[Federal Register Volume 64, Number 235 (Wednesday, December 8, 1999)]
[Rules and Regulations]
[Pages 68854-68914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31181]



[[Page 68853]]

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Part III





Department of Energy





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10 CFR Part 850



Chronic Beryllium Disease Prevention Program; Final Rule

  Federal Register / Vol. 64, No. 235 / Wednesday, December 8, 1999 / 
Rules and Regulations  

[[Page 68854]]



DEPARTMENT OF ENERGY

10 CFR Part 850

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


Chronic Beryllium Disease Prevention Program

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

ACTION: Final rule.

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SUMMARY: The Department of Energy (DOE) is today publishing a final 
rule to establish a chronic beryllium disease prevention program 
(CBDPP) to reduce the number of workers currently exposed to beryllium 
in the course of their work at DOE facilities managed by DOE or its 
contractors, minimize the levels of, and potential for, exposure to 
beryllium, and establish medical surveillance requirements to ensure 
early detection of the disease. This program improves and codifies 
provisions of a temporary CBDPP established by DOE directive in 1997.

EFFECTIVE DATE: This rule is effective January 7, 2000.

FOR FURTHER INFORMATION CONTACT: Jacqueline D. Rogers, U.S. Department 
of Energy, Office of Environment, Safety and Health, EH-51, 1000 
Independence Avenue SW, Washington, DC 20585, 301-903-5684.

SUPPLEMENTARY INFORMATION:
I. Introduction
    A. Background
    B. Chemical Identification and Use
    C. Health Effects
    1. Chronic Beryllium Disease
    2. Beryllium Exposures at DOE Operations
    3. Epidemiology
    4. Value of Early Detection
II. Legal Authority and Relationship to Other Programs
III. Overview of the Final Rule
IV. Section-by-Section Discussion of Comments and Rule Provisions
    A. Subpart A--General Provisions
    B. Subpart B--Administrative Requirements
    C. Subpart C--Specific Program Requirements
    List of Commenters
V. Procedural Requirements
    A. Review Under Executive Order 12866
    B. Review Under the Regulatory Flexibility Act
    C. Review Under the Paperwork Reduction Act
    D. Review Under the National Environmental Policy Act
    E. Review Under Executive Order 13132
    F. Review Under Executive Order 12988
    G. Review Under the Unfunded Mandates Reform Act of 1995
    H. Review Under Small Business Regulatory Enforcement Fairness 
Act of 1996
Appendix A to the Preamble--References
Appendix B to the Preamble--Questions and Answers Concerning the 
Beryllium Induced Lymphocyte Proliferation Test (Be-LPT), Medical 
Records, and the Department of Energy (DOE) Beryllium Registry

I. Introduction

    This final rule implements a chronic beryllium disease prevention 
program (CBDPP) for the Department of Energy (DOE or the Department). 
This program will reduce the number of workers currently exposed to 
beryllium at DOE facilities managed by DOE or its contractors, minimize 
the levels of, and potential for, exposure to beryllium, establish 
medical surveillance requirements to ensure early detection of disease, 
and improve the state of information regarding chronic beryllium 
disease and beryllium sensitization.
    On December 3, 1998, DOE published a Notice of Proposed Rulemaking 
(NOPR) for public comment in the Federal Register (63 FR 66940) 
proposing regulations for a chronic beryllium disease prevention 
program. The public comment period for the NOPR ended on March 9, 1999. 
DOE received 36 comment letters. In addition, public hearings were held 
on February 3, 1999, in Oak Ridge, Tennessee; February 9, 1999, in 
Golden, Colorado; and February 11, 1999, in Washington, DC. Comment 
letters were received from private individuals, DOE contractors, other 
federal agencies, trade associations, academia, public health and 
medical professionals, and attorneys.
    On June 3, 1999, DOE published a notice of limited reopening of the 
comment period (64 FR 29811) to solicit public comments on options that 
DOE was considering for the criteria to be used for the release or 
transfer of equipment and other items previously used in DOE beryllium 
operations, either to other DOE facilities or to the public. In 
response to this reopening of the comment period, DOE received 15 
additional comments.
    DOE has carefully considered the comments and data from interested 
parties, as well as reference works, journal articles, and other 
information relevant to the subject of the rulemaking.

A. Background

    DOE has a long history of beryllium use because of the element's 
broad application to many nuclear operations and processes. Beryllium 
metal and ceramics are used in nuclear weapons, as nuclear reactor 
moderators or reflectors, and as nuclear reactor fuel element cladding. 
At DOE, beryllium operations have historically included melting, 
casting, grinding, and machine tooling of parts.
    Inhalation of beryllium dust or particles can cause chronic 
beryllium disease (CBD) or beryllium sensitization. CBD is a chronic, 
often debilitating, and sometimes fatal lung condition. Beryllium 
sensitization is a condition in which a person's immune system becomes 
highly responsive (allergic) to the presence of beryllium in the body. 
There has long been scientific consensus that exposure to airborne 
beryllium is the only cause of CBD.
    As of September 1999, among the 11,266 current and former DOE 
federal and contractor workers who were screened for the disease, 130 
workers had been diagnosed with CBD, and another 277 workers had become 
sensitized to beryllium. DOE anticipates an increase in the number of 
workers who may be exposed to beryllium as DOE moves forward with 
deactivating and decommissioning former nuclear weapons production 
facilities.
    The current worker protection permissible exposure limit (PEL) of 2 
g/m3, measured as an 8-hour, time-weighted average 
(TWA), was adopted by the Occupational Safety and Health Administration 
(OSHA) in 1971 and codified in 29 CFR 1910.1000, Tables Z-1, Z-2 and Z-
3 by reference to existing national consensus standards. DOE's 
predecessor agency, the Atomic Energy Commission (AEC), had previously 
established the same limit of 2 g/m3 for 
application at its facilities in 1949, and that limit has remained in 
effect at DOE's facilities up to the present. In 1977, the National 
Institute for Occupational Safety and Health (NIOSH), a federal agency, 
recommended to OSHA an exposure limit of 0.5 g/m3 
for beryllium. NIOSH, at the same time, classified beryllium as a 
potential occupational carcinogen.
    Between the 1970s and 1984, there appeared to be a significant 
reduction in the incidence rate of CBD. This, coupled with the long 
latency period for the disease, led to the assumption that CBD was 
occurring only among workers who had been exposed to high levels of 
beryllium decades earlier (e.g., in the 1940s). However, the number of 
confirmed cases of CBD, more recent data suggesting the occurrence of 
CBD among workers with low-level exposures, and the expected future 
increase in the number of workers potentially exposed to beryllium 
(during decontamination and decommissioning activities) all indicate a 
need for more

[[Page 68855]]

aggressive workplace controls to minimize worker exposure to beryllium 
in the DOE complex.
    In December 1998, the American Conference of Governmental 
Industrial Hygienists (ACGIH) published a Notice of Intended Change for 
its beryllium exposure limit. ACGIH is a professional organization that 
develops and publishes consensus occupational health standards. In the 
Notice, ACGIH proposed an 8-hour TWA of 0.2 g/m3 to 
help minimize the occurrence of CBD and sensitization. DOE's NOPR did 
not address ACGIH's proposed change because publication of the NOPR 
preceded ACGIH's announcement.
    DOE has reviewed current technical information and is of the 
opinion that it is difficult to determine the exposure level that is 
necessary to eliminate the risk of contracting CBD. Until OSHA 
completes its rulemaking, DOE has decided to implement an aggressive, 
two-pronged exposure reduction and minimization program that is 
expected to further protect DOE federal and contractor workers from the 
hazards associated with exposure to beryllium. While DOE acknowledges 
that this rule may not eliminate the risk of contracting CBD, DOE 
believes that this rule will significantly decrease the number of 
workers exposed and the level of exposure to beryllium, and therefore, 
is expected to decrease disease. First, DOE is establishing an 8-hour 
TWA action level of 0.2 g/m3 that triggers certain 
workplace precautions and control measures. Second, DOE is requiring 
its contractors and any covered DOE employers to establish in their 
CBDPPs exposure reduction and minimization measures designed to reduce 
potential exposure to levels below the action level. This program will 
enhance and supplement existing worker protection programs established 
under DOE Order 440.1A, Worker Protection Management for DOE Federal 
and Contractor Employees.
    This rulemaking initiative was preceded by several years of 
information gathering and data analysis. In 1996, DOE surveyed its 
contractors to characterize the extent of beryllium usage, the types of 
tasks involving beryllium usage, the controls in place for each task, 
the estimated number of workers exposed during each task, and the 
estimated exposure levels associated with each task. This survey found 
that between 1994 and 1996, 10 of the 15 DOE sites surveyed performed 
64 different operations or processes that could expose workers to 
beryllium. The surveyed DOE sites estimated that between 518 and 530 
workers in 58 different job categories were potentially exposed to 
beryllium in the performance of these 64 operations or processes. These 
estimates were updated in 1999 through a cost survey conducted by the 
Office of Environment, Safety and Health (1999 Environment, Safety and 
Health Cost Survey). In this survey, 14 DOE sites indicated that they 
would be affected by the proposed rule. These sites reported that 1,634 
workers in more than 100 different job categories would be potentially 
exposed to beryllium and 1,236 of these workers (75.6 percent) would be 
potentially exposed at the proposed action level or PEL.
    The 1996 survey also provided information on exposure levels 
experienced by workers at the surveyed sites. Although the exposure 
data were not comprehensive, the reported 8-hour TWA exposure data 
(personal breathing zone monitoring results) for these workers ranged 
from nondetectable to 25 g/m3. Most of these 
exposure levels were reported to be below the 2 g/
m3 8-hour TWA PEL. To control worker exposures in the 
affected processes or operations, the surveyed sites reported the use 
of various engineering and administrative controls, including 
ventilation hoods, glove boxes, wet machining methods, high-efficiency 
particulate air (HEPA) vacuums, regulated areas, action levels and 
administrative warning levels, and personal protective equipment. The 
survey showed that beryllium exposure controls varied considerably 
among the DOE facilities.
    To supplement the data obtained from the 1996 survey, the 
Department published a Federal Register notice on December 30, 1996, 
requesting scientific data, information, and views relevant to a new 
DOE beryllium health standard (61 FR 68725). This was followed by two 
Beryllium Public Forums, one held in Albuquerque, New Mexico, and one 
held in Oak Ridge, Tennessee, in January 1997.
    Acting on the information compiled from these various sources, and 
in view of the time needed to promulgate a rule, then-Secretary of 
Energy Pena directed the Office of Environment, Safety and Health to 
publish a new DOE policy to protect the workforce while the Department 
moved forward with its rulemaking process. DOE Notice 440.1, Interim 
Chronic Beryllium Disease Prevention Program, was signed by Secretary 
Pena and issued on July 15, 1997. This interim Notice established a 
CBDPP that enhanced and supplemented worker protection programs under 
DOE Order 440.1A.
    Because of the complexity and significance of issues regarding the 
development of a DOE beryllium worker protection rule, Secretary Pena 
also established the Beryllium Rule Advisory Committee (BRAC) in June 
1997 to advise DOE on issues pertinent to the proposed rulemaking. The 
BRAC, which consisted of a diverse set of stakeholders and recognized 
experts from DOE, other federal agencies, industry, labor, medicine, 
and academia, explored issues and generated recommendations for 
consideration in the development of a CBDPP rule.\1\
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    \1\ Individual members and groups of members made BRAC 
recommendations. The recommendations were generated by the 
facilitated process used during the meetings and were not adopted by 
the committee as consensus opinions. For convenience of reference 
these recommendations are referred to as the ``BRAC 
recommendations.''
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B. Chemical Identification and Use

    Beryllium (atomic number 4) is a silver-gray, metallic element with 
a density of 1.85 g/cm3 and a high stiffness. The second 
lightest of the metals, beryllium also has a high melting point 
(1285 deg. C) and heat absorption capacity; a pound of beryllium will 
absorb as much heat as 5 pounds of copper.
    Beryllium occurs naturally in the earth's surface in about 30 
minerals found in rocks, coal and oil, soil, and volcanic dust. 
Beryllium used in industry begins as a silicate (BeSiO3) in 
beryl and bertrandite ores. In very pure crystalline form, beryl takes 
the form of gems, such as blue-green aquamarine and green emeralds. 
Bertrandite is mined in Utah. The United States is the world's leading 
producer, processor, and consumer of beryllium products.
    Beryllium, discovered in 1798, was not widely used in industry 
until the 1940s and 1950s. Beryllium can be used as a pure metal, mixed 
with other metals to form alloys, processed to salts that dissolve in 
water, and processed to form oxides and ceramic materials.
    Beryllium metal has been produced for various industrial uses, 
especially in the aerospace and defense industries. Both structural and 
instrument grade materials are manufactured, including windshield 
frames and other structures in high-speed aircraft and space vehicles, 
aircraft and space shuttle brakes, satellite mirrors and space 
telescopes, inertial guidance systems and gyroscopes, neutron 
moderators or reflectors in nuclear reactors, X-ray windows, and 
nuclear weapons components.
    In alloys, beryllium confers on metal specific properties of 
resistance to corrosion, wear, and fatigue; high electrical and thermal 
conductivity;

[[Page 68856]]

strength; and hardness. Beryllium-copper (BeCu) alloys usually contain 
about 2 percent beryllium, but vary greatly in composition to meet 
different industrial and consumer needs. Beryllium is also added to 
aluminum, nickel, zinc, and zirconium for some applications. Beryllium 
alloys are used for springs, switches, relays, and connectors in 
automobiles, computers, radar and telecommunications equipment, and 
other instruments; high-strength non-sparking tools; molds or casts to 
make metal, glass, and plastic items; sports equipment such as golf 
clubs and bicycle frames; and dental bridges and related applications.
    Other beryllium materials include soluble salts and oxides. 
Beryllium soluble salts, such as beryllium fluoride, chloride, and 
sulfate, are used in nuclear reactors, in glass manufacture, and as 
catalysts for certain chemical reactions. Beryllium Oxide (BeO) is used 
to make ceramics for electronics, and other electrical equipment. 
Beneficial properties of BeO include hardness, strength, excellent heat 
conductivity, and good electrical insulation.

C. Health Effects

    DOE received a number of comments (Exs. 2, 5, 14, 19, 20, 22, 23, 
24, 26, 29, 30) \2\ regarding the ``Health Effects'' section of the 
NOPR. DOE has carefully considered these comments and has revised the 
following health effects discussion as appropriate.
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    \2\ A list of commenters is included as an appendix to the 
Section-by-Section Discussion of Comments and Rule Provisions in 
this Supplementary Information section.
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1. Chronic Beryllium Disease
    Chronic beryllium disease (CBD) is a granulomatous lung disease 
that is caused by the body's immune system response (similar to an 
allergic reaction) to inhaled dust or fumes containing beryllium metal, 
alloys, beryllium compounds or mixtures, or insoluble beryllium salts. 
The body's immune system response to beryllium is often called 
beryllium sensitization. Beryllium sensitization precedes the 
development of CBD. Sensitization can occur quickly or many years after 
exposure to beryllium, progressing into disease at a rate of 
approximately 10 percent a year (ref. 1) \3\.
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    \3\ A listing of references is included as an appendix to this 
Supplementary Information section.
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    It is hypothesized that beryllium is a hapten (a substance that 
provokes an immune response only when combined with another substance, 
generally a protein) that binds to peptides on mucosal surfaces. In 
susceptible individuals the beryllium-peptide complex initiates an 
immune response, which may progress ultimately to granuloma formation 
in the pulmonary interstitium. Data have suggested that CBD can occur 
at relatively low exposure levels and, in some cases, after relatively 
brief durations of exposure. The International Agency for Research on 
Cancer (IARC) and ACGIH classify beryllium as a human carcinogen.
    Frequently reported symptoms include one or more of the following: 
dyspnea (shortness of breath) on exertion, cough, fever, night sweats, 
and chest pain and, less frequently, arthralgias (neuralgic pain in 
joints), fatigue, weight loss, or appetite loss. On physical 
examination, a doctor may find signs of CBD results, such as rales 
(changes in lung sounds), cyanosis (lack of oxygen), digital clubbing, 
or lymphadenopathy (enlarged lymph nodes). A radiograph (X-ray) of the 
lungs may show many small scars. Patients may also have an abnormal 
breathing test, pulmonary function test, and a blood test, the 
peripheral blood beryllium-induced lymphocyte proliferation test (Be-
LPT). Examination of the lung tissue under the microscope may show 
granulomas, which are signs of damage due to the body's reaction to 
beryllium. CBD may be confused with other lung diseases, especially 
sarcoidosis. In advanced cases, there may be manifestations of right-
sided heart failure, including cor pulmonale (enlarged right ventricle 
of the heart caused by blockage in the lungs).
    The Be-LPT is highly specific for beryllium sensitivity and has a 
high predictive value for beryllium disease. It is the most definitive 
means of ruling out beryllium disease as the cause of non-specific lung 
and other symptoms. Therefore, this measurement of sensitization to 
beryllium identifies at-risk individuals, as well as individuals whose 
lung problems are not beryllium related (ref. 1). For individuals whose 
Be-LPT screening results exceed a certain threshold, an additional Be-
LPT is conducted on cells washed from a segment of the lung. The 
presence of granulomata in the lung of an individual with a positive 
lung Be-LPT confirms the presence of CBD. In the absence of granulomata 
or other clinical evidence of CBD, individuals with a positive Be-LPT 
are classified as sensitized to beryllium.
    The clinical course of CBD is highly variable. Some individuals 
deteriorate rapidly; most experience long, gradual deterioration. 
Treatment consists of oral corticosteroid therapy. Individuals with 
impaired respiratory gas exchange may require continuous oxygen 
administration.
    Individuals sensitized to beryllium are asymptomatic and not 
physically impaired. Once sensitization has occurred, it is medically 
prudent to prevent additional exposure to beryllium. Individuals with 
CBD have a clinical illness varying from mild to severe. In severe 
cases, the affected individuals may be permanently and totally 
disabled. Mortality of the sensitized individuals directly attributable 
to CBD and its complications is estimated to be 30 percent (ref. 2). 
This estimate is based upon historical data reflecting both the higher 
levels of exposure that occurred in the workplace prior to regulation 
of workplace exposure in the late 1940s and a tracking of the medical 
history of subjects of CBD over several decades. DOE's more recent 
experience with improved diagnoses and treatments may result in a lower 
mortality rate for CBD cases.
2. Beryllium Exposures at DOE Operations
    DOE's medical surveillance programs are discovering cases of CBD 
among workers who were first exposed after 1970, when DOE facilities 
were expected to maintain workers exposure to beryllium below the OSHA 
PEL. As of June 1999, 119 workers (88 at the Rocky Flats facility in 
Golden Colorado, 29 at the Y-12 Plant in Oak Ridge, Tennessee, and two 
at the Hanford facility in Richland, Washington) have been diagnosed 
with CBD, and another 258 workers (197 at the Rocky Flats facility, 59 
at the Y-12 Plant, one at the Hanford facility, and one at the Mound 
facility in Miamisburg, Ohio) have been diagnosed as sensitized to 
beryllium from among approximately 10,000 current and former DOE 
federal and contractor workers who were screened for the disease.
    A worker's exposure is measured by personal monitoring, which is 
accomplished by sampling the air within the breathing zone of the 
worker. Personal monitoring of occupational exposures to beryllium was 
not widely adopted at DOE sites until the 1980s. Prior to the 1980s, 
many sites relied on area monitoring to assess occupational exposures 
to beryllium. However, results from area monitoring have been shown to 
significantly underestimate actual exposure levels. Since 1984, 
personal sampling data have provided more precise information on 
occupational exposure to beryllium at DOE sites.
    Available personal sampling data provides a clear indication of the 
low

[[Page 68857]]

levels of beryllium exposure that can be achieved in both fabrication 
and machining operations, and decommissioning and decontamination 
projects, when effective control strategies are implemented. Most 
beryllium fabrication and machining operations at DOE have occurred to 
date at the Rocky Flats facility, and at the Y-12 Plant. Over time, 
engineering improvements and advanced control strategies have 
significantly reduced occupational beryllium exposure levels in these 
operations.
    Since 1980, and continuing through 1996, about 1600 personal 
samples were collected at the Oak Ridge Y-12 Plant (Table 1). These 
samples were taken at several different Y-12 operations associated with 
CBD, with a bias toward sampling those jobs where exposure potential 
was greatest or where previous monitoring results were high. Despite 
this bias, over two-thirds of sample results were below the limit of 
detection of 0.1 g/m3 for the sampling and 
analytical method used at Y-12.

                     Table 1.--Oak Ridge Y-12 Plant Personal Sampling for Beryllium Exposure
----------------------------------------------------------------------------------------------------------------
                                                       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\
---------------------------------------------------------------------------

    \4\ The rule does not require that exposure reduction and 
minimization efforts (e.g., engineering controls and work practices) 
be triggered by the action level. DOE expects, however, that 
affected sites will specify that some engineering controls and work 
practices be triggered by the action level in their CBDPP plans.
---------------------------------------------------------------------------

     Regulated areas (10 CFR 850.26);
     Hygiene facilities and practices (10 CFR 850.27);
     Respiratory protection (10 CFR 850.28); and
     Protective clothing and equipment (10 CFR 850.29).
    Thus, DOE sites where exposure levels exceed the action level would 
be required to implement these controls to provide further protection 
to workers exposed above the action level. This additional protection 
will reduce the exposure levels experienced by these workers, 
consequently reducing their risk of developing beryllium-related 
disease and other health effects. Setting the action level at 0.2 
g/m3, as opposed to 0.5 g/m3, 
does not alter the set of controls that are triggered,\5\ but does 
alter the timing of these additional controls. The additional 
protective measures triggered by the action level will be put into 
effect earlier. For example, consider an activity where airborne 
concentrations of beryllium start very low (below 0.2 g/
m3), but rise over time (e.g., over a course of days or 
weeks) in the workplace. Assume also that airborne concentrations will 
eventually exceed 0.5 g/m3. If the responsible 
employer recognizes the potential for exposures to exceed the action 
level in this activity, this rule (as well as prudent industrial 
hygiene practice) would require the responsible employer to conduct 
exposure

[[Page 68875]]

monitoring to determine if and when the action level is exceeded. In 
this situation, once the 0.2 g/m3 threshold is 
crossed, the responsible employer would be required to implement the 
controls specified above, and workers would benefit from the additional 
protection provided by those controls. Under an action level of 0.5 
g/m3, protective measures would not be implemented 
until the airborne concentrations exceeded 0.5 g/
m3. Thus, during the time that exposures are between 0.2 
g/m3 and 0.5 g/m3, workers 
would not be afforded the additional protection of the triggered 
controls. Thus, the first incremental benefit of setting the action 
level lower is the reduction in risk afforded by the controls triggered 
during the time that exposures are between 0.2 g/m3 
and 0.5 g/m3 (See Table 9).
---------------------------------------------------------------------------

    \5\ DOE did alter the set of controls that are triggered by the 
action level between the proposed and the final rule. This, however, 
was not done as a result of setting a lower action level, but was in 
response to comments on the proposed rule.
---------------------------------------------------------------------------

    The second benefit from setting the action level lower is to expand 
the number of workers afforded the additional controls (See Table 10). 
DOE believes there are a number of workers exposed to airborne 
concentrations of beryllium between 0.2 g/m3 and 
0.5 g/m3, but who are never exposed above 0.5 
g/m3. DOE estimates that between 342 and 460 
workers may be exposed at these levels.\6\ Under an action level of 0.5 
g/m3, these workers would not be afforded the 
protection of controls triggered by the action level. Under an action 
level of 0.2 g/m3, however, these workers are 
afforded the additional controls. These additional controls will reduce 
the exposures faced by these workers, leading to a reduction in their 
risk of developing beryllium-related disease and other health effects. 
Thus, the second benefit of using the lower action level is a reduction 
in risk among workers exposed to airborne concentrations between 0.2 
g/m3 and 0.5 g/m3.
---------------------------------------------------------------------------

    \6\ The lower bound estimate (342) is the difference between the 
number of workers exposed above the 0.5 g/m3 
action level estimated in the Economic Analysis (EA) for the 
proposed rule (894 workers) and the number of workers exposed above 
the 0.2 g/m3 action level estimated in the EA 
for the final rule (1,236 workers). The estimates contained in the 
two versions of the EA are not, however, completely comparable. In 
developing the EA for the final rule, DOE obtained new data from the 
sites on the number of workers exposed above 0.2 g/
m3. For some sites, the reported number of workers 
exposed above 0.2 g/m3 was less than DOE's 
previous estimate of the number exposed above 0.5 g/
m3. To correct for this inconsistency, DOE used the 
minimum of the two estimates for each site as an estimate of the 
number exposed above 0.5 g/m3. This resulted in 
an estimated 776 workers exposed above 0.5 g/m3. 
The difference between this new estimate and the estimated number 
exposed above 0.2 g/m3 (1,236 workers) provides 
the upper bound estimate (460 workers).
---------------------------------------------------------------------------

    Quantitative estimates of the reduction in risk and the consequent 
reduction in the incidence of beryllium-related disease and other 
health effects are not possible due to a lack of necessary information. 
As discussed in this preamble and the Economic Analysis (Chapter 1, 
Section 1.1), no quantitative dose-response relationship has been 
defined for beryllium. Without this information, DOE is unable to 
provide a quantitative estimate of the benefit of using a lower action 
level. Nevertheless, DOE believes that the use of 0.2 g/
m3 action level as opposed to the 0.5 g/
m3 is justified based on the benefits discussed above and 
the number of comments that suggested that an action level lower than 
0.5 g/m3 is necessary.
    Other issues. This revision to the final rule does not accommodate 
the comments (Exs. 12, 18, 32) that urged DOE to lower its action level 
to any detectable level of beryllium. DOE believes it would not be 
practicable to use any detectable level of beryllium as its action 
level because beryllium is ubiquitous; it can be detected virtually 
anywhere if a sufficiently large air sample is taken. Furthermore, 
according to the EPA's Integrated Risk Information System, discussed 
above, the United States population is being exposed to detectable 
background levels of beryllium without an appreciable risk of 
contracting CBD in their lifetime. Therefore, that level is not 
supported by the available science.

                         Table 9.--Comparative Cost Analysis for Different Action Levels
----------------------------------------------------------------------------------------------------------------
                                                  Annualized  0.5 g/m3 action  0.1 g/m3 Action
                                                   cost for             level                     level
                                                 0.2 g/m3                  Difference                Difference
              Category/requirement                  action                   from 0.2                  from 0.2
                                                    level      Annualized  g/   Annualized  g/
                                                    (final        cost      m3 action       cost      m3 action
                                                    rule)                     level                     level
----------------------------------------------------------------------------------------------------------------
Requirements Triggered By The Action Level in
 the Final Rule:
    Periodic exposure monitoring...............   $1,962,620   $1,104,421  ($858,199)    $3,574,937   $1,612,317
    Notify workers monitoring results..........       66,932       40,411    (26,521)        82,104       15,171
    Exposure reduction and minimization........    2,707,636  2 2,707,636           0     3,579,513      871,877
    Regulated areas............................            0            0           0         8,496        8,496
    Change rooms and showers...................      249,730      249,730           0       272,337       22,607
    Respiratory protection.....................        9,085        9,085           0       342,495      333,410
    Protective clothing........................            0            0           0       382,528      382,528
    Disposal of protective clothing............            0            0           0        42,738       42,738
                                                ----------------------------------------------------------------
      Subtotal.................................    4,996,004    4,111,284   (884,720)     8,285,149    3,289,144
Other Requirements.............................   26,555,397   26,555,397           0    26,555,397            0
                                                ================================================================
      Total for all requirements 1.............   31,551,401   30,666,680   (884,720)    34,840,545   3,289,144
----------------------------------------------------------------------------------------------------------------
Note: Column totals may contain some rounding error.
1 For this row, the annualized cost represents the annualized cost of the proposed rule for the specified action
  level.
2 The costs for exposure reduction and minimization may be lower with a 0.5 g/m3 action level since
  fewer requirements would be triggered under the higher action level. The information provided to DOE by the
  sites, however, did not contain enough information to make an estimate of the reduction in the costs for this
  category.
 


[[Page 68876]]


                            Table 10.--Estimated Number of Workers by Exposure Level
----------------------------------------------------------------------------------------------------------------
                                                                                   Estimated      Percent of all
                  Beryllium exposure levels (g/m\3\)                      number of         affected
                                                                                  workers \1\        workers
----------------------------------------------------------------------------------------------------------------
0.0 to 0.1....................................................................               0                0
0.1 to 0.2....................................................................             398             24.4
0.2 to 0.5....................................................................      342 to 460     20.9 to 28.2
Above 0.5.....................................................................      776 to 894     47.5 to 54.7
                                                                               ---------------------------------
      Total...................................................................           1,634              100
      Total Above 0.1.........................................................           1,634              100
      Total Above 0.2.........................................................           1,236            75.6
----------------------------------------------------------------------------------------------------------------
\1\ The Economic Analysis (EA) for the final rule estimates that 1,236 workers are exposed above the action
  limit of 0.2 g/m\3\ and that a total of 1,634 workers are currently exposed to beryllium. Thus, 398
  workers must be exposed below 0.2 g/m\3\ (398 = 1,634-1,236). Given that measurements of exposure
  levels below 0.1 g/m\3\ begin to near the detection limits, DOE assumes that all workers exposed
  below 0.2 g/m\3\ would be in the 0.1 to 0.2 group. Next, DOE estimated the upper bound of the above
  0.5 group by taking the estimated number of workers exposed above 0.5 g/m\3\ from the EA for the
  proposed rule (i.e., 894 workers). The difference between this number and 1,236 (the number exposed above 0.2
  g/m\3\) provided the lower bound of the 0.2 to 0.5 group (342 = 1,236+894). To provide the lower
  bound of the above 0.5 group (776 workers), DOE corrected for an inconsistency between the EA for the proposed
  rule and the EA for the final rule. In developing the EA for the final rule, DOE obtained new data from the
  sites on the number of workers exposed above 0.2 g/m\3\. For some sites, the reported number of
  workers exposed above 0.2 g/m\3\ was less than DOE's previous estimate of the number exposed above
  0.5 g/m\3\ (in the EA for the proposed rule). To correct for this inconsistency, DOE used the minimum
  of the two estimates (i.e., the estimated number of workers exposed above 0.2 g/m\3\ in the EA for
  the final rule and the estimated number of workers exposed above 0.5 g/m\3\ in the EA for the
  proposed rule) for each site as an estimate of the number exposed above 0.5 g/m\3\. This resulted in
  an estimated 776 workers exposed above 0.5 g/m\3\ which DOE uses as the lower bound for that group.
  The difference between this number and the estimated number exposed above 0.2 g/m\3\ (1,236 workers)
  provides the upper bound estimate for the 0.2 to 0.5 group (460 = 1,236-776).
 
Note: Column total may contain some rounding error.

Section 850.24--Exposure Monitoring
    Section 850.24 establishes CBDPP worker exposure monitoring 
requirements. The exposure monitoring provisions in this section are 
necessary to determine the extent of exposure at the worksite; prevent 
worker overexposure; identify the sources of exposure to beryllium; 
collect exposure data so that the responsible employer can select the 
proper control methods to be used; evaluate the effectiveness of 
selected controls; and provide continual feedback on the effectiveness 
of the program in controlling exposures. These requirements are more 
specific than the provisions of exposure monitoring in DOE Order 
440.1A.
    Exposure monitoring is important not only to determine the level of 
beryllium to which workers are exposed and the frequency at which 
workers should be monitored, but also to determine whether other 
protective provisions of the rule need to be implemented. The 
employer's obligation to provide respiratory protection under section 
850.28, for example, is triggered by monitoring results showing that a 
worker is exposed at or above the action level. Exposure monitoring 
results also may help DOE to resolve uncertainties regarding the 
adequacy of the existing beryllium PEL and to refine the requirements 
of this rule as needed to protect worker health.
    Because of the importance of adequately characterizing and 
monitoring worker exposures to beryllium, DOE included a specific 
request in the NOPR asking interested persons for views or information 
on the need for daily exposure monitoring of all beryllium workers. DOE 
was considering whether daily exposure monitoring was needed to 
document and characterize more completely a worker's exposure to 
beryllium, and to better evaluate the adequacy of existing exposure 
levels or determine appropriate levels for alternative exposure limits. 
Of the ten commenters who responded to this request for information, 
three favored a daily monitoring requirement while seven were opposed.
    The commenters who favored daily monitoring for all workers (Exs. 
18, 25, 30) argued that daily monitoring of each worker would more 
accurately document and characterize beryllium exposures. One commenter 
(Ex. 16) suggested that initial daily monitoring could be replaced with 
periodic monitoring after sufficient data was obtained. Another (Ex. 
30) noted that daily exposure monitoring might be the only accurate way 
to determine exposures during changing workplace conditions. This 
commenter suggested that daily monitoring is important in identifying 
specific work activities that contribute to the worker exposures.
    The majority of commenters responding to this request (Exs. 3, 4, 
16, 17, 26, 28, 29) objected to daily monitoring of all workers to 
determine beryllium exposures. These commenters stated that daily 
monitoring would generate large amounts of data, at great cost, while 
producing little or no added benefit. Some of these commenters (Exs. 3, 
26, 28, 29) favored representative sampling of the workplace, using 
statistical analysis to determine the number of samples required. These 
commenters asserted that the principal benefits of a statistically-
based monitoring strategy would be the reduction in the number of 
samples needed and resources used.
    After considering all of the comments, DOE agrees that daily 
monitoring would be unnecessarily burdensome for responsible employers, 
and that a statistically-based approach will ensure the adequate 
characterization of worker exposures. This position is reflected in 
section 850.24(b), as discussed below.
    Section 850.24(a) requires that exposure monitoring be managed by a 
qualified individual such as a CIH, and conducted by individuals with 
sufficient industrial hygiene knowledge and experience. DOE requested 
in the NOPR that interested persons submit comments on the need to 
further specify the minimum qualifications that an individual must 
possess to perform certain key functions under the CBDPP, including 
exposure monitoring. Most of the commenters suggested or supported 
adding a requirement that exposure monitoring be performed under the 
supervision of a CIH. DOE agrees that a CIH is often best qualified to 
manage exposure monitoring activities, and provides in section 
850.24(a)(1) that exposure monitoring performed for the CBDPP be 
managed by a qualified individual, such as a CIH. However, in keeping 
with the performance-based philosophy underlying this rule, DOE

[[Page 68877]]

does not preclude a responsible employer from determining, in a 
particular situation, that a person other than a CIH possesses the 
requisite knowledge to perform this function. Most of the commenters 
were of the view that individuals conducting the monitoring, under the 
management of a qualified individual, need sufficient knowledge and 
experience but not necessarily the same level of qualification as a 
CIH.
    Section 850.24(b) requires the responsible employer to perform 
initial exposure monitoring for all persons who work in areas that may 
have airborne concentrations of beryllium, as determined through the 
baseline beryllium inventory and hazard assessment. The responsible 
employer must employ a statistically-based monitoring strategy to 
obtain the number of samples needed to characterize worker exposures. 
The initial exposure information is necessary to determine the need for 
engineering and work practice controls, to select appropriate personal 
protective clothing and respiratory protective equipment where needed, 
and to identify the need to establish regulated areas. One commenter 
(Ex. 28) recommended that sampling should be conducted to determine 
particle size and chemical characterization of the potential exposure, 
and another commenter (Ex. 30) recommended use of particle size-
selective personal monitoring. DOE has decided to leave details of this 
nature to the qualified individual who manages exposure monitoring 
under the CBDPP, rather than attempt to prescribe them in regulations. 
This type of issue also may be addressed in future DOE guidance on 
implementing the CBDPP.
    Section 850.24(b)(1) requires the responsible employer to determine 
the beryllium exposure of workers by collecting personal breathing zone 
samples that reflect worker's exposure to airborne concentrations of 
beryllium over an eight-hour period. As specified in the definition of 
``worker exposure'' in section 850.3, this is a measurement of the 
exposure that would occur if the worker were not using respiratory 
protective equipment. Section 850.3 also includes a definition of 
``breathing zone,'' which means ``a hemisphere forward of the 
shoulders, centered on the mouth and nose, with a radius of 6 to 9 
inches.'' Thus, a breathing zone sample is taken as close as practical 
to the nose and mouth of the worker. For a full description of 
breathing zone samples, see OSHA's Instruction CPL 2-2.20B, CH-1, Nov. 
13, 1990.
    DOE recognizes that many of its responsible employers may have 
performed initial monitoring as part of their efforts to implement DOE 
Notice 440.1. DOE does not intend to require employers to repeat these 
efforts if they are adequate under the rule. Accordingly, section 
850.24(b)(2) allows employers to use initial monitoring data collected 
within 12 months before the effective date of this rule to satisfy the 
rule's initial monitoring requirements. One commenter (Ex. 31) 
cautioned DOE that any sampling performed prior to the issuance of the 
final beryllium rule should only be accepted by DOE if the work 
conditions during the sampling period are the same as current 
conditions. DOE agrees with this commenter, and notes that several 
provisions of the final rule require responsible employers to ensure 
that sampling results reflect current workplace conditions. 
Specifically, section 850.24(b) requires that the responsible employer 
obtain a sufficient number of sample results to adequately characterize 
exposures, and section 850.24(d) requires that the responsible employer 
perform additional monitoring if operations, maintenance, or procedures 
change, or if the responsible employer has any reason to suspect a 
change has occurred which may result in new or additional exposures. 
Further, DOE believes that the requirement that exposure monitoring be 
managed by a qualified individual will help assure that exposure 
monitoring results accurately characterize worker exposures.
    Section 850.24(c) requires the responsible employer to conduct 
periodic exposure monitoring of workers who work in areas where 
airborne concentrations of beryllium are at or above the action level. 
Periodic monitoring provides the responsible employer with assurance 
that workers are not experiencing higher exposures that may require the 
use of additional controls. In addition, periodic monitoring reminds 
workers and responsible employers of the continued need to protect 
against the hazards associated with exposure to beryllium. The 
collection of exposure monitoring data also enables the SOMD to be 
informed of the existence and extent of potential sources of beryllium 
exposure.
    Some commenters argued that the periodic monitoring requirements in 
the rule should be more conservative than proposed in the NOPR. For 
instance, one commenter (Ex. 13) recommended that the requirement for 
periodic monitoring be implemented if employee exposures exceed 10% of 
the PEL while another commenter (Ex. 18) suggested that periodic 
monitoring be required for all workers regardless of previously 
measured exposures. DOE has addressed the first commenter's concerns by 
establishing the action level in the final rule at no greater than 0.2 
g/m\3\ (ten percent of the PEL). DOE does not believe that 
periodic monitoring should be mandated for all workers regardless of 
exposure level, as suggested by the other commenter, but rather that 
the responsible employer should determine the frequency of periodic 
monitoring where levels are below the action level. However, DOE does 
encourage sites to establish lower action levels to trigger components 
of their CBDPP, as part of their exposure reduction and minimization 
efforts required under section 850.25.
    A third commenter (Ex. 14), addressing the periodic monitoring 
requirements of proposed section 850.24(c), stated that periodic 
monitoring on a continuous basis is the only way to determine worker 
exposures. While DOE acknowledges that certain operations may warrant 
continuous monitoring due to the dynamic nature of day-to-day 
operations, DOE believes that an inflexible, one-size-fits all 
monitoring policy is inappropriate due to the wide range of beryllium-
related operations within the DOE complex. Accordingly, DOE provides 
responsible employers the flexibility to determine the monitoring 
frequency that is needed to sufficiently characterize worker exposures. 
DOE believes that responsible employers are best positioned to evaluate 
the potential variability of worker exposures in their operations and 
to tailor their periodic monitoring approaches as appropriate. 
Nevertheless, because slight process or procedural changes may go 
unnoticed over time and because equipment maintenance, aging, or 
deterioration can affect performance, DOE, in section 850.24(c), is 
requiring a minimum exposure monitoring frequency of every 3 months 
(quarterly) for workers who are exposed to airborne concentrations of 
beryllium at or above the action level.
    DOE recognizes that the minimum quarterly monitoring of workers 
exposed at or above the action level is more frequent than is required 
in most OSHA expanded health standards. However, DOE considers this 
minimum monitoring frequency to be necessary due to the uncertainties 
regarding the adequacy of the current PEL. To supplement this periodic 
monitoring requirement, section 850.24(d) requires that responsible 
employers perform additional exposure monitoring when beryllium-related 
operations or

[[Page 68878]]

procedures change, or they have any reason to suspect a change, which 
may cause new or additional exposures to workers. This additional 
monitoring is needed to protect workers from elevated exposures 
resulting from changed circumstances, to quantify how changes affect 
worker exposure to airborne beryllium, to ensure the continued 
effectiveness of existing engineering and work-practice controls, and 
to identify the need for additional control measures to minimize worker 
exposure to beryllium.
    To obtain accurate exposure monitoring results, section 850.24(e) 
requires that responsible employers use monitoring and analytical 
methods that have accuracy, at a confidence level of 95 percent, of not 
less than plus or minus 25 percent for airborne concentrations of 
beryllium at the action level. The main reason DOE is requiring this 
degree of accuracy for exposure monitoring results is to ensure that 
exposure monitoring results are sufficiently accurate at the exposure 
level that is relevant for the CBDPP. Accuracy of measurements is 
critical, since certain central requirements of the rule (e.g., 
engineering controls, exposure reduction and minimization, respirator 
use, and regulated areas) are triggered by measured worker exposures 
that meet or exceed the action level. In addition, the medical removal 
provision requires that a removed worker not be placed in a job where 
exposure levels are at or above the action level.
    Section 850.24(f) further ensures the quality of monitoring results 
by requiring that all laboratory analyses of air sampling data be 
performed in a laboratory accredited for metals by the AIHA, or a 
laboratory that demonstrates quality assurance for metals that is 
equivalent to AIHA accreditation. Equivalency to AIHA's accreditation 
means that a laboratory can demonstrate that their testing protocols 
meet the accreditation standards of AIHA. These accuracy and quality 
requirements are consistent with similar requirements that appear in 
many of OSHA's expanded health standards for toxic substances. The only 
commenter (Ex. 13) to address this issue agreed with DOE that the use 
of an AIHA accredited laboratory will ensure the quality control, 
consistency, and accuracy of beryllium sample analyses. DOE has added 
to the final rule the language ``or a laboratory that demonstrates 
quality assurance for metals analysis that is equivalent to AIHA 
accreditation,'' to provide responsible employers more flexibility in 
selecting a laboratory and to allow the use of an appropriate 
laboratory currently being used by the employer.
    Section 850.24(g)(1) requires responsible employers to notify 
affected workers of monitoring results, in writing, within 10 working 
days of receipt of the monitoring results. This section also provides 
responsible employers with two alternative methods of worker 
notification: (1) written notification to each affected worker, or (2) 
posting of monitoring results in a location or locations readily 
accessible to affected workers. Two commenters (Exs. 16, 23) expressed 
concern about the use of personal identifiers in posted monitoring 
results, citing worker privacy concerns.
    One commenter (Ex. 26) objected strongly to DOE's proposal to 
provide notice to workers in a manner that does not identify the 
worker. This commenter argued that not only is there no right to 
privacy implicated by posting of sampling results, but that anonymous 
notification would not further personal accountability for work 
practices. This commenter cited the Atomic Weapons Establishment's 
(AWE) experience at its Cardiff (United Kingdom) facility to show the 
beneficial effects of peer pressure on individual workers' adherence to 
good work practice. DOE recognizes AWE's experience and the benefits of 
peer pressure on workers' adherence to good work practices. However, 
DOE is following the approach used in OSHA's substance-specific 
standards that have posting requirements, which does not incorporate 
the principle of applying peer pressure to establish good work practice 
procedures. DOE, therefore, provides in the final rule that when the 
posting option is selected, responsible employers must post the results 
without disclosing the identity of the affected workers. This 
protection of workers' privacy is consistent with OSHA's substance-
specific standards that have posting requirements.
    Sections 850.24(g)(2) and (3) deal with cases in which monitoring 
results indicate that the worker exposure level meets or exceeds the 
action level. In such cases, the responsible employer is required by 
paragraph (g)(2) to include in the notice to workers a description of 
the corrective actions being taken to reduce worker exposure to below 
the action level. Paragraph (g)(3) requires the responsible employer to 
notify the SOMD of the results within 10 working days of receipt of the 
monitoring results. DOE believes that the SOMD must be informed of such 
exposures in order to refine, as appropriate, the medical surveillance 
protocol for affected workers to ensure effective monitoring and early 
detection of beryllium-related health effects.
Section 850.25--Exposure Reduction and Minimization
    Section 850.25 establishes the exposure reduction and minimization 
provisions of the CBDPP that reflect DOE's goal of achieving aggressive 
reduction and minimization of worker exposures to airborne beryllium.
    Section 850.25(a) establishes the baseline requirement that 
responsible employers ensure that no worker is exposed to airborne 
beryllium at levels above the exposure limit established in section 
850.22.
    Section 850.25(b)(1) requires the responsible employer to include 
in the CBDPP a formal exposure reduction and minimization program to 
reduce exposure levels that are at or above the action level to below 
the action level, if practicable. Sections 850.25 (b)(1)(i)-(iv) 
provide that the formal exposure reduction and minimization program 
must include: (1) exposure reduction and minimization goals, (2) the 
rationale to support the goals and a strategy for achieving them, (3) 
the specific actions that the responsible employer plans to take to 
achieve the goals, and (4) a means of tracking progress towards meeting 
the goals or demonstrating that the goals have been met. Where levels 
are below the action level, section 850.25(b)(2) requires responsible 
employers to include in their CBDPP a description and rationale for the 
steps they plan to take to reduce and minimize exposures, if such steps 
are practicable. Such steps are applicable when exposures are measured 
below the action level to provide additional worker protection. This 
requirement assures responsible employer's commitment to address and 
further reduce exposures, as practicable, below the action level and 
implementing the steps included in their CBDPP.
    Section 850.25(c) provides that responsible employers must apply 
the hierarchy of industrial hygiene controls, as already required under 
DOE Order 440.1A, to achieve exposure control. This hierarchy dictates 
that responsible employers first must implement feasible engineering 
controls, followed by administrative controls, in their efforts to 
reduce and minimize exposures. Responsible employers can supplement 
these controls with personal protective clothing and equipment to 
reduce exposures where engineering and administrative controls are not 
feasible.
    In summary, section 850.25 establishes a graded approach to 
reducing and minimizing beryllium exposures to levels as low as

[[Page 68879]]

practicable. This approach is familiar to the DOE community because it 
is similar to DOE's ``as low as reasonably achievable'' approach to 
radiation protection. DOE's requirement that the responsible employer 
establish a formal program of setting and tracking reduction goals for 
exposures above the action level will result in greater management 
attention to potential high exposures. The requirement that the 
responsible employer take steps to reduce and minimize exposures that 
are below the action level commits DOE to continue reducing and 
minimizing exposures, but without the same level of management 
attention since these exposures are believed to represent a lower risk 
to workers.
    Six persons commented on the exposure reduction and minimization 
requirements of the proposed rule. Two of the commenters (Exs. 18, 23) 
recommended that the rule require responsible employers to initiate 
reduction and minimization actions to maintain exposures below the 
action level, rather than below the exposure limit. DOE would 
essentially be setting a new DOE exposure limit if it followed this 
recommendation. As previously explained, DOE believes that setting a 
new exposure limit would be inappropriate because the scientific data 
is not fully developed and does not yet provide an adequate basis for 
determining an appropriate new limit. The discussion of section 850.22, 
Permissible Exposure Limit, provides greater detail on the issue of 
lowering the exposure limit.
    Three of the commenters (Exs. 4, 18, 33) made recommendations that 
relate to the appropriate trigger for requiring responsible employers 
to initiate reduction and minimization actions where exposure levels 
are below the action level. Two commenters (Exs. 18, 33) recommended 
that the rule require responsible employers to initiate reduction and 
minimization actions wherever beryllium is detected. One commenter (Ex. 
4) interpreted Table 5 in the NOPR preamble to mean that DOE would 
expect the responsible employer to undertake actions anywhere exposure 
levels are greater than zero. DOE believes that using either the limit 
of detection or greater than zero as the trigger is not practicable 
because trace levels of beryllium are ubiquitous, and beryllium levels 
in air can be measured everywhere if a large enough air sample is taken 
to accumulate sufficient beryllium to exceed the lower detection limit 
of the analytic method being used. DOE believes that final section 
850.25(b)(2) best meets DOE's intention of establishing an effective 
performance-based rule by requiring responsible employer actions, if 
practicable, where exposure levels are below the action level.
    Another commenter (Ex. 3) questioned the efficacy of enforcing a 
rule that allows each site to establish individual exposure reduction 
and minimization goals. DOE believes that this approach is adequately 
enforceable based on its positive experience using contractual 
mechanisms to enforce similar requirements in radiation protection 
regulations.
Section 850.26--Regulated Areas
    Section 850.26 establishes the regulated area provisions of the 
CBDPP. Regulated areas are an effective means of minimizing the number 
of workers exposed to airborne concentrations of beryllium because they 
prevent or minimize the spread of beryllium to clean areas. This is 
consistent with good industrial hygiene practice whenever exposure to a 
toxic substance can cause serious health effects.
    The final rule's requirements for regulated areas are essentially 
the same as those proposed, with certain good hygiene practices being 
added in response to a commenter's (Ex. 1) concern discussed below 
under section 850.26(d).
    Section 850.26(a) requires the responsible employer to establish 
regulated areas where, based on breathing zone samples, the employer 
determines that workers are exposed to airborne concentrations of 
beryllium at or above the action level.
    Three commenters addressed this provision, as proposed, and 
suggested either alternate or supplemental criteria to trigger the 
establishment of regulated areas. One commenter (Ex. 18) suggested that 
the trigger level be lowered to require that regulated areas be 
established wherever beryllium is detected. DOE believes that the final 
rule's significantly lower action level provides a suitable mandatory 
trigger for the establishment of regulated areas. In addition, DOE 
believes that the CBDPP exposure reduction and minimization provisions 
will result in the use of an even lower site-specific action level as 
improved controls become feasible throughout the DOE complex.
    The two other commenters (Ex. 3, 34) suggested that the proposed 
provision for regulated areas be supplemented with a surface 
contamination level limit that would trigger the establishment of 
regulated areas. No reliable correlation has been established between 
surface contamination level and airborne concentrations of beryllium. 
DOE, therefore, believes that using a surface contamination level limit 
as a trigger for the establishment of regulated areas would produce 
minimal benefits to worker health and has not adopted this 
recommendation.
    One of the commenters (Ex. 3) suggested that if engineering or 
process controls bring exposure levels to below the action level in a 
regulated area, the area should remain a regulated area to ensure that 
controls remain in place. DOE does not agree with this comment. While 
the rule would not prevent responsible employers from implementing such 
a practice, requiring that regulated area provisions remain in effect 
after exposures have been reduced to acceptable levels would impose 
additional financial burdens on employers with no corresponding 
improvement in worker protection. In addition, DOE believes that such a 
mandatory provision could undermine the incentives this rule creates 
for employers to implement effective engineering or process controls. 
If employers were required to maintain regulated areas regardless of 
whether they had implemented effective engineering controls, employers 
might have less motivation to implement the controls. This commenter's 
concern is at least partly addressed by section 850.24(d), which 
requires the performance of additional exposure monitoring if 
operations or procedures change or if the employer suspects a change 
that could affect exposure levels.
    Section 850.26(b) of the rule requires responsible employers to 
demarcate areas where worker exposures are at or above the action level 
in a manner that alerts workers to the boundaries of such areas. Under 
section 850.38 of this part, warning signs must be posted, stating that 
only authorized personnel are allowed in the area. Due to the serious 
nature of the adverse health effects associated with exposure to 
beryllium, no one should be in a regulated area without proper personal 
protection.
    Section 850.26(c) requires responsible employers to limit access to 
regulated areas to authorized persons only. DOE intends that only 
individuals who are essential to the performance of work in the 
regulated area will be authorized to enter regulated areas. Responsible 
employers will have to evaluate the affected operation and determine 
which personnel (including managers, supervisors, and workers) are 
necessary for the performance of the work and thus are authorized to 
enter. Methods for preventing unauthorized persons from entering a 
regulated area may include posting a sign indicating that only 
authorized persons may enter, the use of locked access doors, and other

[[Page 68880]]

security measures as required by worksite conditions. DOE believes that 
employers are best equipped to determine whether any access control 
methods are needed in addition to warning signs specified in section 
850.38.
    Two commenters (Exs. 1, 31) suggested the incorporation of 
additional personal hygiene controls, specifically recommending that 
the rule prohibit smoking, eating, and drinking in regulated areas. DOE 
agrees with these commenters and has included in section 850.27 a 
prohibition on smoking, eating, and drinking in areas where beryllium 
is above the action level (i.e., in regulated areas).
    Section 850.26(d) requires responsible employers to keep a record 
of all persons who enter regulated areas. The record must include the 
name of the person who entered, the date of entry, the time in and time 
out, and the type of work performed. One commenter (Ex. 26) stated that 
a log of worker activities is not needed unless DOE is conducting a 
``prospective risk assessment.'' This commenter believed that a simple 
log, only documenting who entered regulated areas, would be sufficient. 
The intended function of these records is clarified in section 850.39, 
Recordkeeping and Use of Information. DOE believes that recordkeeping 
must be adequate to permit DOE to monitor the effectiveness of each 
responsible employer's compliance activities and to provide information 
regarding each worker's history of potential exposures. This 
information will assist the responsible employer's occupational 
medicine staff in establishing appropriate medical surveillance 
protocols and will aid in DOE's efforts to establish links between 
working conditions and potential health outcomes. DOE has retained the 
proposed regulated area recordkeeping requirements in section 850.26(d) 
of the final rule.
Section 850.27--Hygiene Facilities and Practices
    Section 850.27 of the final rule retains the NOPR requirements for 
responsible employers to provide change rooms or areas and hand washing 
and shower facilities for beryllium workers. In addition to these 
provisions, the final rule also requires responsible employers to 
provide lunchroom facilities that are readily accessible to beryllium 
workers, ensure that tables for eating are free of beryllium, that no 
worker is exposed at any time at or above the action level, and 
specifies that all of these facilities must comply with the 
requirements of 29 CFR 1910.141. These hygiene provisions are common in 
OSHA's expanded health standards designed to protect workers from 
exposures to hazardous particulates.
    Sections 850.27(a)(1) and (2) requires responsible employers to 
assure that workers observe prohibitions on the availability and use of 
cosmetics, tobacco and chewing products, and food and beverages in 
areas where beryllium is above the action level. Section 850.27(a)(3) 
requires responsible employers to prevent beryllium workers from 
exiting areas that contain beryllium with contamination on their bodies 
or their personal clothing. DOE believes that these provisions promote 
sound work place hygiene practices that may protect workers from 
exposure to other substances present in the workplace, as well as 
beryllium. These provisions are commonly included in OSHA's substance-
specific health standards.
    Section 850.27(b) requires responsible employers to provide clean 
change rooms or areas for workers who work in regulated areas. In 
addition, section 850.27(b)(1) requires that separate facilities be 
provided for workers to change into and store personal clothing and 
clean protective clothing and equipment. DOE believes that such 
provisions are necessary to prevent cross-contamination between work 
and personal clothing and the subsequent spread of beryllium into clean 
areas of the facility and into workers' private automobiles and homes. 
These provisions also address the need to prevent contamination of 
clean protective clothing and equipment, ensuring that protective 
clothing and equipment actually protect workers rather than contribute 
to their exposures.
    Section 850.27(b)(2) requires that the change-rooms used to remove 
beryllium-contaminated clothing and protective equipment be maintained 
under negative pressure, or be located in a manner or area that 
prevents dispersion of beryllium contamination into clean areas.
    DOE received two comments on the hygiene facilities and practices 
provisions of the NOPR. A commenter (Ex. 25) suggested that the 
requirement to provide change rooms, hand washing facilities, and 
showers be based on a hazard assessment. DOE believes that requiring 
responsible employers to perform a separate hazard assessment to 
determine the need for change rooms and showers is unnecessary and 
overly burdensome to responsible employers. The requirement for change 
rooms and showers is triggered by the requirement to establish 
regulated areas. Regulated areas, in turn, are required wherever a 
hazard assessment identifies the potential for worker exposures at or 
above the action level. Thus, the requirement for change rooms and 
showers is already indirectly triggered by the results of a hazard 
assessment.
    A commenter (Ex. 23) expressed concern that the impact and burden 
of constructing new change rooms for D&D closure sites has not been 
considered in the development of the change room provisions, and argued 
that alternative methods of compliance should be considered for D&D 
operations. In fact, DOE has addressed the economic impact of requiring 
responsible employers to provide change rooms for workers in the 
economic analysis prepared for the NOPR and made available for public 
review. Based on that economic analysis, DOE is aware that the cost of 
change rooms may be substantial for some DOE facilities. However, DOE 
believes that providing change rooms and showers for workers who work 
in regulated areas is the most effective method for preventing workers 
from carrying beryllium contamination on their work clothes and bodies 
from regulated areas to other areas of DOE facilities and to workers' 
private automobiles and homes. DOE is unaware of any equally effective 
alternative method for achieving this objective and, thus, has retained 
the change room and shower provisions in the final rule. The economic 
burden may be lessened by steps employers already have taken to comply 
with existing hygiene facility requirements. For example, 29 CFR 
1910.120(n)(7) of OSHA's Hazardous Waste Operations and Emergency 
Response standard already requires employers to provide showers and 
change rooms for workers on D&D operations of six months duration or 
longer. DOE contractors at DOE sites are subject to this requirement 
through their contracts, which require compliance with DOE Order 440.1A 
or other analogous Orders or standards.
    Consistent with the goal of preventing the spread of contamination 
into adjacent work areas and into affected workers' homes, section 
850.27(c)(1) requires responsible employers to provide shower and hand-
washing facilities for workers assigned to regulated areas. In addition 
to controlling the spread of contamination, showering also reduces the 
worker's period of exposure to beryllium by removing any beryllium that 
may have accumulated on the skin and hair. Requiring workers to change 
out of work clothes, which are segregated from their street clothes, 
and to shower before leaving the plant, leaving work clothing

[[Page 68881]]

at the workplace, significantly reduces the movement of beryllium from 
the workplace. These steps ensure that the duration of beryllium 
exposure does not extend beyond the work shift and, thus, protect 
workers and their families from off-site exposures. DOE recognizes that 
the installation of such facilities may take time in some cases. 
Accordingly, section 850.13(b) of the final rule allows responsible 
employers two years to achieve full compliance with the requirements of 
the rule.
    Section 850.27(d) requires responsible employers to provide 
beryllium workers working in regulated areas with readily accessible 
lunchroom facilities in which tables for eating are free of beryllium 
and no worker is exposed at any time to a concentration of beryllium at 
or above the action level. DOE believes that it is imperative that 
workers have a clean place to eat to reduce the likelihood of 
additional exposure to loose beryllium dust through inhalation or 
ingestion.
    Responsible employers must also assure that workers in regulated 
areas do not enter the lunchroom wearing protective clothing unless the 
clothing is properly cleaned beforehand. Responsible employers are 
given discretion to choose any method for removing surface beryllium 
from the clothing that does not disperse the dust into the air. These 
requirements are similar to the hygiene facilities and practices 
provisions in a number of OSHA's health standards.
Section 850.28-Respiratory Protection
    Section 850.28 establishes the respiratory protection requirements 
for the CBDPP. Section 850.28(a) requires that responsible employers 
comply with OSHA's Respiratory Protection standard (29 CFR 1910.134). 
Section 850.28(b) requires that responsible employers provide 
appropriate respiratory protective equipment for all workers exposed, 
or potentially exposed based upon task analyses, to airborne 
concentrations of beryllium at or above the action level. This section 
also requires the responsible employer to ensure that workers use 
respirators. Section 850.28(c) requires the responsible employer to 
include in the respiratory protection program any beryllium-associated 
worker who requests to use a respirator, regardless of exposure level. 
Section 850.28(d) requires that responsible employers select and use 
only National Institute for Occupational Safety and Health (NIOSH)-
approved respiratory protective equipment or, if none exist for a DOE 
beryllium activity, DOE-accepted respiratory protective equipment.
    Some of the requirements of section 850.28 are not new. For 
instance, DOE contractors have historically been required to comply 
with OSHA standards, including 29 CFR 1910.134, through contract 
provisions requiring compliance with DOE Order 440.1A and its 
predecessor orders. DOE also has followed OSHA standards in 
implementing the Federal Employee Occupational Safety and Health 
Program. DOE Order 440.1A requires employers to provide, and DOE 
workers to use, appropriate respiratory protective equipment necessary 
to protect workers from exposures to hazardous substances. In addition, 
the provisions of 29 CFR 1910.134 include a requirement that employers 
select only NIOSH-approved respirators. DOE Order 440.1A expands this 
requirement to allow for the use of DOE-accepted respiratory protection 
if NIOSH-approved respiratory protection does not exist for a specific 
DOE task. The provisions of section 850.28 that are new in this final 
rule are the requirements for the use of respiratory protection: (1) at 
the action level (rather than at OSHA's PEL); (2) based on the analyses 
of job activities (rather than only on measured levels); and (3) when 
requested by beryllium-associated workers regardless of exposure level. 
DOE does not expect that these new provisions will greatly increase the 
number of workers who wear respirators at DOE sites. Under current 
practice, DOE sites require use of respirators at their established 
action level (ranging from 0.2 to 1.0 g/m\3\) rather than at 
the PEL (see CBDPP Economic Analysis, Chapter 3, Section 3.2.8).
    The NOPR (Section V, Request for Information) requested comments on 
changing the trigger for requiring respiratory protection from the PEL 
to the action level. Seven of the thirteen commenters on respiratory 
protection (Exs. 16, 18, 23, 25, 26, 28, 30) recommended that the rule 
be more protective of workers' health by requiring the use of 
respiratory protection at the proposed action level. None of the 
remaining four commenters on this issue (Exs. 3, 4, 20, 31) recommended 
retaining the PEL as a trigger. The seven supporters of using the 
action level as a trigger represent a wide variety of stakeholders. 
These commenters' predominant reason for recommending the more 
protective level as the trigger is the uncertainty about the protection 
afforded by the current PEL. These commenters provided the following 
additional reasons for lowering the respiratory protection trigger from 
the PEL to the action level: (1) To provide a greater margin of safety 
because of the imperfections in measuring exposure levels; (2) to 
provide a greater margin of safety because of the imperfections in 
understanding how to set exposure limits for materials, such as 
beryllium, for which the cause of illness is the body's immune system 
reaction; and (3) to establish an internally consistent CBDPP which 
includes consistent triggers for its protective provisions and, 
therefore, is rational and easy to communicate. DOE generally agrees 
with these comments and has revised section 850.28 to require the use 
of respirators when exposures are at or above the action level.
    One commenter (Ex. 3) was concerned that using the action level as 
a trigger for respiratory protection would render the action level a de 
facto PEL, because OSHA uses the PEL as the trigger for respiratory 
protection in OSHA substance-specific standards. Similarly, two 
commenters (Exs. 4, 20) believed that using the action level as a 
trigger for respiratory protection signifies that DOE believes that the 
PEL is not adequately protective. Section I.C., Health Effects, of the 
Supplementary Information section provides a detailed explanation of 
the difficulties of determining a safe threshold level for occupational 
exposure to beryllium, given the current state of knowledge of 
occupational exposures and the etiology of beryllium disease. DOE's 
strategy is to require a rigorous program to prevent chronic beryllium 
disease by reducing and minimizing exposures, while studies continue 
that may provide the data needed to establish a safe level of exposure 
to airborne beryllium. The preamble discussions of sections 850.22 and 
850.23 explain in greater detail DOE's rationale for continuing to 
defer to OSHA's PEL, while establishing a more protective action level 
for DOE.
    One commenter (Ex. 26) recommended that the responsible employer 
provide respiratory protection when warranted based upon an analysis of 
the worker's job activities. DOE recognizes that many tasks involving 
beryllium may result in high concentrations of airborne beryllium due 
to a procedure error, a work error, or an equipment failure. An 
analysis of the worker's job activities will determine whether 
respiratory protection is necessary for such tasks. Therefore, DOE 
added section 850.28(b)(2) requiring responsible employers to provide 
respiratory protection for task involving such circumstances.

[[Page 68882]]

    Two commenters (Exs. 26, 30) recommended that the responsible 
employer provide respiratory protection when it is not otherwise 
required if requested by a worker due to the uncertainty about what is 
a safe level and uncertainties in monitoring and controlling a 
substance like airborne beryllium. DOE agrees with these commenters and 
has added section 850.28(c), which requires the responsible employer to 
provide respiratory protection upon the request of the beryllium-
associated worker regardless of measured exposure levels.
    One commenter (Ex. 3) recommended requiring respiratory protection 
for exposures at or above the STEL. DOE agrees with the commenter that 
the STEL would have been an appropriate trigger for respiratory 
protection if the action level had remained at 0.5 g/m\3\. 
However, a STEL of 10 g/m\3\ for 15 minutes, as proposed in 
the NOPR, would provide no added protection for workers as a trigger 
for respiratory protection in the final rule because its action level 
of 0.2 g/m\3\ will be exceeded in less than 15 minutes where 
exposure levels are at 10 g/m\3\. As explained in the 
discussion of section 850.22, DOE has decided that it would not be 
appropriate, given the current science, to establish a lower STEL in 
this rule.
    DOE has clarified its expectations on the use of DOE-accepted 
respirators in response to one commenter (Ex. 31) who questioned the 
use of DOE-accepted respirators rather than NIOSH-approved respirators. 
This requirement as proposed in section 850.28(c) could have been 
interpreted, as it was by this commenter, to mean that responsible 
employers could choose between NIOSH-approved respirators and DOE-
accepted respirators. This was not DOE's intent. DOE's revision in 
section 850.28(d)(2) clarifies that responsible employers may use the 
DOE-accepted respirators only if NIOSH-approved respirators do not 
exist for particular DOE tasks. This section also references DOE's 
Respirator Acceptance Program to clarify that DOE only accepts for use 
respirators that DOE deems acceptable based upon the results of a 
formal testing and evaluation program.
    One commenter (Ex. 31) recommended that the rule specify that all 
respiratory protective equipment be furnished at no cost to the worker. 
Section 850.28(a) requires that responsible employers comply with 29 
CFR 1910.134, Respiratory Protection, which currently requires in 
section 1910.134(c)(4), that employers provide respirators at no cost 
to the employee. Accordingly, DOE will continue to rely upon OSHA's 
requirements in lieu of making specific changes to the rule.
Section 850.29-Protective Clothing and Equipment
    Section 850.29 establishes the protective clothing and equipment 
provisions (other than respirator use) of the CBDPP. The objectives of 
this section are to provide clothing and equipment that protects 
workers against the hazards of skin and eye contact with dispersible 
forms of beryllium and to prevent the spread of contamination outside 
work areas that could occur from the improper handling of beryllium-
contaminated clothing and equipment.
    DOE has clarified the proposed requirement for the responsible 
employer to provide protective clothing and equipment where skin or eye 
contact with beryllium is possible. Section 850.29(a) requires that 
responsible employers provide protective clothing and equipment to 
beryllium workers where dispersible forms of beryllium may contact 
workers' skin, enter openings in workers' skin, or contact workers' 
eyes.
    The openings in workers' skin could include fissures, cuts, and 
abrasions. DOE recognizes that the potential for the development of 
contact dermatitis, chronic ulcerations, and conjunctivitis is mainly 
associated with contact with soluble forms of beryllium compounds that 
are not included in the definition of ``beryllium'' in this rule. 
Insoluble beryllium, however, has also been shown to cause chronic 
ulcerations if introduced into or below the skin via cuts or abrasions 
(ref. 34). DOE believes that it is prudent industrial hygiene practice 
to avoid skin or eye contact with a material that causes chronic 
ulcerations and, therefore, has included protecting workers' skin and 
eyes from contact with insoluble beryllium in section 850.29(a). The 
protective equipment required by this section could include coveralls, 
overalls, jackets, footwear, headwear, face shields, goggles, gloves, 
and gauntlets, depending on the nature of the operation and the related 
skin and eye exposure hazards involved.
    In the NOPR, DOE requested information regarding the presence of 
soluble beryllium compounds within the DOE complex and the 
appropriateness of the exclusion of such compounds from the definition 
of ``beryllium'' in the proposed rule. In addition, DOE requested 
comments regarding the need for the protective clothing and equipment 
provisions of proposed section 850.29(a)(2), given a DOE survey that 
had found that soluble beryllium compounds apparently were not present 
within the DOE complex. One commenter (Ex. 4) recommended excluding 
soluble beryllium from section 850.29 based on that survey result. 
However, as a result of other public comments, DOE learned that that 
survey result was incorrect because one DOE commenter (Ex. 16) 
indicated that its facilities contain soluble beryllium. Moreover, 
other commenters (Exs. 26, 30) pointed out that DOE facilities may 
contain soluble beryllium in the future.
    Nevertheless, DOE has not changed the definition of ``beryllium'' 
in the final rule to include soluble forms of beryllium, because the 
principal focus of this rule is on preventing CBD, which is caused by 
exposure to insoluble forms of beryllium. One commenter (Ex. 26) 
correctly pointed out that the skin and eye effects that this section 
is intended to prevent are different health effects than CBD. Although 
another commenter (Ex. 25) questioned DOE's view that soluble beryllium 
exposure to the lungs does not cause CBD, DOE finds no evidence in the 
information on health effects presented in section I.C. that exposure 
of the lungs to soluble forms of beryllium causes CBD. DOE expects 
responsible employers to address soluble beryllium hazards in existing 
worker protection programs under DOE Order 440.1 or analogous Orders or 
standards cited in responsible employers' contracts with DOE.
    Section 850.29(a)(1) requires responsible employers to provide 
protective clothing and equipment to beryllium workers, at no cost, 
where airborne beryllium levels are measured or presumed to be at or 
above the action level, because elevated airborne levels are likely to 
generate elevated surface levels which represent a skin and eye hazard. 
DOE has included ``presumed to be'' in section 850.29(a)(1) in response 
to a recommendation that one commenter (Ex. 26) made with respect to 
respiratory protection that applies equally to protective clothing and 
equipment. The commenter recommended that the responsible employer 
provide respiratory protection when warranted based upon task analyses. 
DOE recognizes that many tasks involve beryllium that could readily 
become airborne in high concentrations due to a procedure error, a 
worker error, or an equipment failure, but which will have no 
measurable exposure level unless one or more of these problems occur. 
DOE believes that an analysis of the worker's job activities would show 
the need for protective clothing and equipment, and respiratory 
protection to perform such activities.

[[Page 68883]]

    Another commenter (Ex. 3) recommended that DOE add a surface 
contamination level that would also trigger the requirement to provide 
protective clothing and equipment. DOE agrees with this commenter 
because elevated surface levels represent a skin and eye hazard, and, 
accordingly, DOE has added paragraphs (a)(2) and (a)(3) to this 
section. Section 850.29(a)(2) requires responsible employers to provide 
protective clothing and equipment to beryllium workers where surface 
contamination levels are measured to be, or prior to initiating work 
are presumed to be, above the housekeeping level prescribed in section 
850.30. Section 850.29(a)(3) requires responsible employers to provide 
protective clothing and equipment to beryllium workers where surface 
contamination level results obtained to confirm housekeeping efforts 
are above the prescribed housekeeping level.
    Section 850.29(a)(2) addresses the situation in which the 
responsible employer is planning to conduct a task involving beryllium 
and has time to measure or estimate surface levels before the task 
begins. Section 850.29(a)(3) addresses the situation in which the 
responsible employer learns from routine surface monitoring conducted 
at the end of a shift that housekeeping efforts did not reduce surface 
levels to below the surface contamination level specified in section 
850.30. DOE recognizes that sampling to confirm the adequacy of 
housekeeping efforts at the end of shifts, and the turnaround time of 
as much as 24 hours for sample analysis, could result in workers not 
using protective clothing and equipment for more than a day where 
surface contamination levels exceed the prescribed surface 
contamination level. However, DOE believes that these situations will 
be rare, because routine post-shift cleaning should keep these surface 
contamination levels from becoming excessive. Also, DOE believes that 
responsible employers will be motivated to reduce turnaround times for 
analyses in their efforts to reduce and minimize exposures. DOE 
selected the term ``results'' in section 850.29(a)(3) to avoid creating 
a situation in which the responsible employer would violate the rule 
simply because the employer did not know that the housekeeping 
criterion had been exceeded until surface monitoring results were 
available.
    Section 850.29(a)(4) requires the responsible employer to provide 
protective clothing and equipment upon the request of the beryllium-
associated worker, regardless of measured exposure levels.
    Section 850.29(b) incorporates into this rule 29 CFR 1910.132, 
Personal Protective Equipment General Requirements. This OSHA standard 
is responsive to a commenter's (Ex. 31) recommendation that the rule 
should require the responsible employer to furnish the clothing and 
equipment at no cost to the employee, and covers other well-established 
practices, such as the topics to be included in protective clothing and 
equipment training, and ensuring that protective clothing and equipment 
fits properly. This requirement to comply with 29 CFR 1910.132 is 
consistent with the general worker protection provisions of DOE Order 
440.1A, and analogous Orders or standards cited in the responsible 
employer's contract with DOE.
    Section 850.29(c)(1) requires the responsible employer to establish 
procedures for donning, doffing, handling, and storing protective 
clothing and equipment that prevent beryllium workers from exiting 
areas that contain beryllium with contamination on their bodies or 
their personal clothing. DOE added this provision because one commenter 
(Ex. 3) correctly pointed out that it was omitted in the proposed rule 
and is needed to ensure that workers do not track contamination out of 
areas that contain beryllium. The same commenter recommended that DOE 
explicitly require HEPA vacuuming of contaminated protective clothing 
and equipment as part of the required doffing procedure. This final 
rule does not include a requirement to include HEPA vacuuming in 
doffing procedure, because DOE believes that this would not allow the 
employer sufficient flexibility in selecting cleaning procedures.
    Section 850.29(c)(2) requires that the procedures for donning, 
doffing, handling, and storing protective clothing and equipment 
include a requirement that beryllium workers exchange their personal 
clothing for full-body protective clothing and footwear (work shoes or 
booties) before beginning work in regulated areas. This change from 
personal clothes into protective work clothing must occur in a change 
room that protects the worker's personal clothes and clean protective 
clothing from beryllium contamination. DOE believes that the use of 
full-body protective clothing in lieu of personal clothes in regulated 
areas is necessary to prevent the spread of beryllium contamination 
into adjacent work areas and to preclude the possible transport of 
beryllium onto affected workers' private property. A recent study (ref. 
35) has documented the transport from work areas of beryllium on 
workers' hands and inside their personal vehicles.
    One of DOE's objectives is to prevent the spread of beryllium 
contamination, thereby reducing the number of persons exposed and the 
opportunities for potential exposures. Thus, sections 850.29(d) through 
(f) establish provisions to control the handling, maintenance, 
cleaning, and disposal of beryllium-contaminated protective clothing 
and equipment.
    Section 850.29(d) requires the responsible employer to ensure that 
workers do not remove beryllium-contaminated protective clothing and 
equipment from areas that contain beryllium, except for authorized 
activities such as cleaning and repairing the clothing and equipment. 
DOE replaced ``site'' in the proposed rule with ``area that contains 
beryllium'' in the final rule to clarify its intent to minimize 
contamination of other areas at the site as well as outside the site.
    Section 850.29(e) requires the responsible employer to prohibit the 
removal of beryllium from protective clothing and equipment by blowing, 
shaking, or other means that may disperse beryllium into the air. 
Although DOE generally believes that responsible employers should have 
the flexibility to determine the most appropriate means to clean 
contaminated clothes based on their own specific worksite conditions, 
DOE has included this well recognized and accepted industrial hygiene 
control to prevent the dispersion of beryllium particles into the 
workplace atmosphere.
    Section 850.29(f), which was proposed as section 850.29(c), 
requires responsible employers to clean, launder, repair, and replace 
protective clothing and equipment as needed to ensure its continued 
effectiveness in protecting workers. This section allows contractors 
flexibility in determining the required frequency for laundering 
protective clothing based on specific work conditions and the potential 
for contamination.
    Section 850.29(f)(1), which was proposed as section 850.29(b), 
paragraphs (1)-(2), requires the responsible employer to ensure that 
protective clothing and equipment removed for laundering, cleaning, 
maintenance, or disposal, is placed in containers that prevent the 
dispersion of beryllium dust, and that these containers are labeled in 
accordance with section 850.38. These warning labels will help ensure 
appropriate subsequent handling of beryllium-

[[Page 68884]]

contaminated materials and may prevent inadvertent exposures that could 
result if laundry, maintenance, or disposal personnel are not aware of 
the beryllium contamination and the precautions prescribed by the 
responsible employer to prevent the release of airborne beryllium. In 
section 850.29(f)(1) of the final rule, DOE has deleted the words 
``impermeable'' and ``are designed'' which were in proposed section 
850.29(b)(1) in response to a commenter's (Ex. 8) recommendation to 
clarify DOE's intent. This change eliminates the possible implication 
that DOE expects responsible employers to provide special containers 
even if existing containers are capable of preventing the spread of 
contamination.
    Section 850.29(f)(2), which was proposed as section 850.29(d), 
requires the responsible employer to ensure that organizations that 
launder or clean DOE beryllium-contaminated protective clothing or 
equipment are informed that exposure to beryllium is potentially 
harmful, and that clothing and equipment should be laundered or cleaned 
in the manner prescribed by the responsible employer to prevent the 
release of airborne beryllium. DOE replaced ``any individual'' with 
``organizations'' to clarify that DOE's objective for this section is 
to ensure that any organization that launders beryllium contaminated 
clothing is informed of the hazards of handling beryllium contaminated 
items so that the organization can take steps to protect its workers. 
The proposed wording ``any individual'' could have been interpreted as 
establishing a direct relationship between the responsible employer 
that generated the contaminated clothing and the employee of the 
laundry or cleaning organization, which is not DOE's intent. Also, DOE 
clarifies in section 850.29(f)(2) that this section requires informing 
both on-site cleaning and laundry services, as well as off-site 
cleaning and laundry vendors. On-site cleaning and laundry services are 
covered by this rule, but may not know about the presence and hazards 
of beryllium on the clothing and equipment unless the responsible 
employer informs them.
    DOE has deleted the words ``at or above the action level or above 
the STEL,'' which in proposed section 850.29(a) qualified the 
requirement to inform downstream launderers or cleaners of beryllium-
contaminated protective clothing and equipment. This change is 
consistent with final section 850.25, which requires reduction and 
minimization, if practicable, where exposure levels are below the 
action level.
    One commenter (Ex. 31) recommended including in the rule provisions 
for preventing heat stress. DOE recognizes that requiring protective 
clothing and equipment for dispersible forms of beryllium compounds at 
the final rule's lower action level is likely to result in greater use 
of protective clothing and equipment, including respirators, and 
consequently greater potential for heat stress. DOE believes that the 
health benefit from lowering the risk of CBD outweighs any increased 
health risk caused by heat stress that results from the requirements of 
this section. DOE has not included heat stress provisions in this rule 
because it is a potential problem for many DOE activities that require 
the use of protective clothing and equipment; and DOE expects heat 
stress issues to be addressed in the responsible employer's existing 
worker protection program.
Section 850.30--Housekeeping
    Section 850.30 establishes the housekeeping provisions of the 
CBDPP. Good housekeeping practices are necessary in operational areas 
where beryllium is used or handled, to prevent the accumulation of 
beryllium contamination on surfaces throughout the workplace. Such 
accumulations, if not controlled, may lead to the spread of beryllium 
contamination on surfaces and the re-suspension of beryllium particles 
into the air, both in the area where beryllium dusts were originally 
generated and in other work areas. In addition, the uncontrolled 
accumulation of beryllium-contamination on equipment in the workplace 
increases the potential for worker exposure to beryllium during the 
performance of equipment maintenance, handling, and disposal tasks.
    DOE in section 850.30(a) has established that the removable 
contamination housekeeping level on surfaces must not exceed 3 
/100 cm2 during non-operational periods. 
Establishing a surface removable contamination limit reduces the 
potential for spread of beryllium contamination. Responsible employers 
must perform measurements to determine if the operational work area is 
in compliance with the rule. In addition, monitoring surface 
contamination levels is an indispensable tool for ensuring that 
beryllium emissions from operations are under control. The only 
practical method of monitoring surface levels is to maintain the 
surface contamination at an established housekeeping level so that 
elevations above that level can readily be detected.
    The performance of housekeeping tasks can, in and of itself, lead 
to worker exposures to beryllium-contaminated dust. Therefore, the 
housekeeping section also seeks to prevent the spread and re-suspension 
of dust during housekeeping activities.
    Two commenters (Exs. 26, 28) questioned the scientific basis for 
establishing a 3 g/100 cm2 surface removable 
contamination level. In addition, these two commenters stated that the 
variability associated with wipe sampling makes surface sampling method 
an unreliable method for sampling. DOE views wipe sampling as a useful 
and accepted method for providing qualitative information on chemical 
contamination of work surfaces, and agrees with the following statement 
in the OSHA Technical Manual (Section II: Chapter 2, Sampling for 
Surface Contamination): ``Wipe sampling is an important tool of work 
site analysis for both identifying hazardous conditions, and in 
evaluating the effectiveness of * * * housekeeping, and decontamination 
programs.'' Accordingly, this requirement is intended only as a 
housekeeping performance measure, and should not be viewed as a 
mechanism for measuring, or predicting airborne concentrations of 
beryllium. In addition, this requirement only applies to removable or 
loose surface contamination, which could become re-suspended in the 
workplace air or spread to non-controlled areas.
    DOE does not intend the requirement for surface wipe sampling in 
this rule to preclude the use of other surface sampling methods for 
measuring beryllium contamination. DOE agrees with comments calling for 
more research (Exs. 16, 28) and encourages the use, research, and 
development of new technologies such as direct reading instruments, 
which may provide better results than wipe sampling.
    Section 850.30(a) requires that responsible employers conduct 
routine surface sampling in operational areas, to ensure the 
effectiveness of their housekeeping efforts. This sampling would not 
include the interior of installed closed systems such as enclosures, 
glove boxes, chambers, or ventilation systems. Sampling should not be 
carried out during a normal work shift, but rather it should be 
undertaken after normal clean-up and during non-operational periods.
    Affected sites throughout DOE have already established, under the 
interim CBDPP, allowable beryllium surface contamination levels to 
ensure the

[[Page 68885]]

effectiveness of their housekeeping procedures. These levels range from 
1 to greater than 5 g/100 cm2, with the majority of 
the sites using approximately 3 g/100 cm2 or less 
as the criterion for determining the cleanliness of their working 
environment outside of regulated areas. Comments on the NOPR called for 
setting levels ranging from less than 1 g/100 cm2 
(Exs. 14, 18) to 5 g/100 cm2 (Ex. 24). Information 
collected from the sites during the development of the interim 
beryllium CBDPP indicated that the Pantex and Y-12 facilities currently 
have an allowable surface concentration level of 25 g/100 
cm2 for regulated areas. Los Alamos National Laboratory 
(LANL) procedures call for re-evaluation of the operations with 
additional cleaning of beryllium operations areas at levels greater 
than 26 g/ft2 (2.8 g /100 cm2). 
Lawrence Livermore National Laboratory (LLNL) indicated those areas 
with surface concentrations greater than 3 g/100 
cm2 are designated as regulated areas. Rocky Mountain 
Remediation Services (a sub-contractor at Rocky Flats) indicated that a 
surface contamination level greater than 25 g/ft (2.7 
g/100 cm2) outside of regulated areas triggers 
clean up actions at its site. The AWE facility at Cardiff (United 
Kingdom) has utilized a surface action level of 10 g/
ft2 (1 g/100 cm2) outside of regulated 
areas since 1990. Based on this range of data, DOE adopted the 3 
g/100 cm2 housekeeping level in the proposed rule 
and continues to believe it is a reasonable surface removable 
contamination level that should not be exceeded.
    One commenter (Ex. 3) recommended that the surface removable 
contamination level be the same level as the criterion for releasing 
contaminated equipment for other uses. Another commenter (Ex. 23) 
objected to establishing a single surface limit for removable beryllium 
contamination that would be both a housekeeping and release level, 
recommending instead a tiered approach, with different levels for 
normal or safe work conditions (and free release of equipment), for 
beryllium work, and for special work conditions. For the reasons 
discussed under section 850.31, Release Criteria, DOE has adopted 
different levels for the release of equipment that depend on the 
intended future use of the equipment.
    One commenter (Ex. 24) expressed concern that certain beryllium 
oxide weapons components could not meet the 3 g/100 
cm2 level, and recommended that weapons components be exempt 
from surface contamination limits. DOE has revised section 850.30 to 
clarify that the surface removable contamination level is to be 
measured post-shift, and that the purpose of the surface level is not 
to have an absolute value of 3 g/100 cm2 at all 
times during the machining or working with beryllium or beryllium 
parts. DOE is aware that it may not be possible to maintain surface 
levels of beryllium in an operational work area below the 3 g/
100 cm2 limit at all times. Again, the surface removable 
contamination level is intended as a post-shift measure of the 
effectiveness of routine housekeeping efforts.
    DOE emphasizes that the housekeeping concerns addressed by section 
850.30 apply to areas where workers may be exposed to beryllium, not to 
closed-off rooms or buildings. To make this clear, DOE has added the 
term ``operational areas'' in section 850.30(a). If routine surface 
sampling during non-operational or post-shift periods shows that the 
removable contamination level has been exceeded, clean-up measures must 
be instituted.
    DOE agrees with the comment (Ex. 28) that the meaning of the term 
``removable'' contamination may not be clear. Therefore, DOE has added 
a new definition of ``removable contamination'' and deleted the 
definition of ``surface contamination'' in section 850.3. The 
definition of ``removable contamination'' is taken from the U.S. 
Department of Energy Radiological Control Manual (DOE/EH-0256T Revision 
1, April 1994). Use of this language in this rule maintains a 
consistent approach with DOE's radiological surface sampling program.
    Two commenters suggested the use of wet wipes for surface sampling, 
while another commenter (Ex. 24) indicated that there is no basis for 
the application of a wet method. NIOSH, in its recent publication on 
beryllium contamination inside worker vehicles, supports the use of a 
wet wipe sampling method to collect beryllium samples in potentially 
contaminated employee vehicles (ref. 35).
    The use of diverse sampling methods (e.g., differences in type of 
sample media, type of solvent (if any) on the sample media, area 
sampled, etc.) may easily lead to the reporting of inconsistent 
results. To reduce the variability in reported surface contamination 
across the DOE complex, DOE recommends, but does not require, the use 
of a single sampling method: NIOSH method 9100 (NIOSH Manual of 
Analytical Methods, 4th Edition, August 15, 1994, Lead in Surface Wipe 
Samples). This method may have to be modified for surfaces smaller than 
100 cm2 using a procedure such as that described in Appendix 
D of 10 CFR part 835. Sites using other methods, e.g., dry wipe 
sampling, should transition to the NIOSH method in a cost-effective 
manner. Current data is not clear on the relative efficiency of dry 
verses wet sampling on the variety of surfaces found in the DOE. 
Therefore, immediate adoption of the NIOSH method at sites across DOE 
may be impractical and add no immediate value to worker health and 
safety. In the long term, by recommending a single method (a wet 
method) for conducting the surface sampling, DOE believes that the 
variability associated with surface sampling will be reduced without 
specifying a particular method in the rule.
    One commenter (Ex. 3) suggested that the term ``routine'' in 
section 850.30(a) should be more clearly defined, i.e., weekly or 
monthly. Because DOE believes that this rule should be as performance-
based as possible, the frequency of ``routine'' monitoring procedures 
under this section should be developed by the local health and safety 
specialist (industrial hygienist) based on the specific circumstances 
at the site.
    Section 850.30(b) prohibits the use of compressed air or dry 
methods and requires the use of vacuuming, wet or similar methods for 
the cleaning of beryllium-contaminated floors and other surfaces. The 
purpose of using these methods is to reduce or eliminate the potential 
for re-suspension of beryllium dust into the air and breathing zone of 
the worker.
    One commenter (Ex. 23) requested flexibility in cleaning methods, 
such as permitting the use of sticky tack cloths. DOE agrees with the 
comment and in the final rule has allowed the use of other cleaning 
methods, such as sticky tack cloths, that have the same end result as 
wet vacuuming (i.e., a reduction of dust-producing cleaning methods). 
These are appropriate methods for complying with the housekeeping 
requirement of the rule.
    Section 850.30(c) requires the use of HEPA filters in all vacuuming 
operations used to clean contaminated or potentially contaminated 
surfaces, and further requires filter replacement as needed, to 
maintain the capture efficiency of the vacuum system. The use of wet 
methods for reducing or minimizing the dispersal of dust during general 
housekeeping tasks, such as sweeping, is a common industrial hygiene 
practice. HEPA filters must be used to prevent the spread of dust by 
effectively collecting the dust that is collected by vacuum systems. 
Responsible employers should have procedures for the cleaning or 
replacement of filters that ensure

[[Page 68886]]

minimum employee exposure to beryllium dust on the filter.
    As discussed in earlier sections of this analysis, the movement of 
contaminated equipment from a regulated area to a nonregulated area may 
result in the spread of beryllium contamination to the nonregulated 
area. To prevent the potential spread of contamination from the 
performance of housekeeping activities required by this rule, section 
850.30(d) requires that cleaning equipment used in areas where surfaces 
are contaminated or potentially contaminated with beryllium be labeled, 
controlled, and not used for other, non-hazardous materials. These 
procedures are similar to those required under OSHA's asbestos standard 
for equipment used during cleanup or removal of asbestos from 
buildings.
Section 850.31--Release Criteria
    Section 850.31 establishes beryllium contamination levels and other 
requirements that must be met before equipment and other items used in 
beryllium work areas may be released or transferred to the general 
public and non-beryllium areas of DOE facilities, or to facilities 
engaged in work involving beryllium. DOE requested comments on the 
setting of ``beryllium free-release'' public contamination levels in 
the NOPR. After considering the comments received in response to this 
broad request for views and information, DOE reopened the comment 
period on June 3, 1999, to invite public comment on specific options 
for release criteria that were being considered by DOE (64 FR 29811). 
Section 850.31 reflects DOE's consideration of the substantial number 
of comments received from organizations and individuals on this topic.
    In the notice of reopening of the comment period, DOE suggested 
that a reasonable contamination level for release of equipment and 
other items to the public for non-beryllium uses would be 0.1 
g/100cm2. This level was based on the housekeeping 
and release levels believed to be in effect at various DOE facilities 
and the AWE facility in the United Kingdom. DOE also stated that it was 
inclined to adopt a contamination level of 3 g/100 
cm2 for release of items for beryllium work in other 
facilities. This level was based principally on the practice at the 
Rocky Flats.
    Ten organizations and individuals submitted comments that 
recommended release level values. These values ranged from non-
detectable to 3 g/100 cm2 for public release and 
non-detectable to 10 g/100 cm2 for release to 
beryllium facilities.
    One commenter (Ex. 47) stated that there should be a single 
contamination level for both the housekeeping standard for beryllium 
areas and for release of items for beryllium and non-beryllium uses. 
Another commenter (Ex. 43) urged DOE to adopt a single criterion for 
release to the public and DOE non-beryllium facilities and to 
beryllium-handling facilities because it would be simpler to 
administer. DOE does not agree with these comments, because the workers 
in operational areas where beryllium is used have been trained in the 
hazards of beryllium and the proper use of protective equipment that is 
required to be worn in those areas. DOE does not believe that the 
general population or DOE non-beryllium workers should be exposed to 
the same level of a hazardous material as workers who have been trained 
in the safe handling of that material. DOE, therefore, has included in 
the rule separate requirements for the release of beryllium-
contaminated equipment and other items to facilities engaged in 
beryllium work and for releases to the general public or DOE non-
beryllium facilities.
    Section 850.31(a) requires the responsible employer to clean 
beryllium-contaminated equipment and other items to a contamination 
level that is as low as practicable, but not to exceed the removable 
contamination levels specified in section 850.31(b), for release to the 
general public or to non-beryllium areas of DOE facilities, and section 
850.31(c), for release to facilities performing work with beryllium. In 
addition, DOE has included in these sections other requirements that 
are designed to protect workers and others from the hazards associated 
with exposure to beryllium. DOE uses the words ``and other items'' 
after ``equipment'' in section 850.31(a) to cover tools, supplies, 
documents, etc., and any personal property in beryllium-handling areas 
that may not be encompassed by the term ``equipment.'' The phrase 
``equipment and other items'' does not include real property or 
buildings.
    Release to the public and for use in DOE non-beryllium areas. 
Section 850.31(b)(1) sets the removable contamination level for 
equipment and other items to be released to the general public or for 
use in DOE non-beryllium work areas at 0.2 g/100cm2 
or the concentration level of beryllium in soil at the point of 
release, whichever is higher. The equipment also must be labeled, in 
accordance with section 850.38(b), to warn recipients of potential 
beryllium hazards. The responsible employer must condition the release 
of equipment and other items to the public based on the recipient's 
commitment to implement controls to ensure that exposure does not 
occur. Such a commitment should be based on the nature and possible 
future uses of the equipment and other items, the nature of the 
beryllium contamination, and whether exposure to beryllium is 
foreseeable.
    In the notice of reopening, DOE referenced a comment by the AWE 
(Ex. 1) which reported that the housekeeping surface action level in 
its Cardiff, Wales facility had been reduced to 1 g/ft\2\ 
(about 0.1 g/100 cm\2\) in 1990. DOE reasoned that, based on 
the AWE experience and release limits included in DOE facilities' 
interim CBDPPs, a public release limit as low as 0.1 g/100 
cm\2\ would be achievable. Several commenters (Exs. 41, 43, 46, 47, 51) 
argued that this level would be difficult and costly to achieve, and 
that there is no technical basis for concluding that it would be more 
beneficial than a higher level. AWE (Ex. 38) commented that it is not 
using 0.1 g/100 cm\2\ as a release level; its current policy 
is to dispose of contaminated items in a landfill site. The Pantex 
Plant (Ex. 46) stated that its reported use of 0.1 g/100 cm\2\ 
as a release criterion was incorrect, possibly due to a typographical 
error, and it recommended using 3 g/100 cm\2\ for the public 
release limit. Rocky Flats (Ex. 47) pointed out significant differences 
between the AWE Cardiff facility, which is a stable work environment, 
and the Rocky Flats facility, which is engaged in decontamination and 
decommissioning work. Two commenters (Exs. 43, 46) argued that a 
surface removable contamination level of 0.1 g/100 cm\2\ could 
easily be exceeded by background levels of beryllium.
    Other commenters (Exs. 44, 45, 48, 49) took the position that any 
detectable level of beryllium on the surface of an item should be 
presumed to present a health risk and, therefore, that no item having a 
detectable level of beryllium should be released to anyone for any 
purpose. One commenter (Ex. 48) stated that the correlation between 
surface beryllium levels and associated health hazards is unknown, and 
the possibility exists for fixed or inaccessible beryllium to be 
liberated when equipment is worked on or repaired. Another commenter 
(Ex. 49) stated that DOE should take a cautious stance because of the 
current lack of information regarding the nature of the exposure-
response relationship and the factors that underlie individual 
sensitization towards beryllium. Two commenters (Exs. 49, 52) 
recommended life-cycle

[[Page 68887]]

administrative controls for beryllium-contaminated equipment.
    Section 850.31(b)(3) responds to the recommendation of comments 
(Exs. 26, 38) calling for a risk assessment that considers the 
downstream user's exposure potential, the history and type of 
equipment, and the nature of the contamination, in order to decide 
whether and how to release equipment and other items for non-beryllium 
uses. As recognized by DOE in the reopening notice, surface or wipe 
sampling is not an adequate means of characterizing potential exposure 
risk. For example, a lathe or other piece of equipment released because 
it is determined to be beryllium-free on the surface may contain 
internal beryllium dust that could become airborne and present a health 
hazard during future maintenance. On the other hand, other types of 
equipment may contain internal beryllium that is combined with other 
substances (e.g., grease) which would make it unlikely that the 
beryllium would ever become airborne. The presence of this type of 
suspended contamination, even at levels above the surface release 
criterion, would not necessarily present a health hazard. Accordingly, 
an assessment of potential risk of exposure should be undertaken before 
the release of any equipment or other item to either the general public 
or to DOE for non-beryllium uses. Based upon the assessment, the 
decision should be made as to ultimate disposition of the equipment and 
any conditions that should be placed on its future use.
    After considering the comments, DOE is persuaded that it would be 
costly, if not infeasible, to implement a contamination level of 0.1 
g/100 cm\2\ or lower as the public release criterion. Section 
850.31(a)(1) requires responsible employers to clean equipment and 
other items to the lowest contamination level practicable and to ensure 
that removable contamination on surfaces does not exceed 0.2 
g/100 cm\2\ or the concentration level of beryllium in local 
soil. This removable contamination criterion is based, in large 
measure, on information provided in comments submitted by the 
contractor that manages the Rocky Flats facility (Ex. 47). To comply 
with the interim CBDPP established by DOE Notice 440.1, Rocky Flats 
conducted an extensive site characterization (over 6000 samples) using 
0.2 g/100 cm\2\ as the target contamination level. Rocky Flats 
reported that they found the 0.2 g/100 cm\2\ to be an 
achievable level and determined (using recently published re-suspension 
factors) that any airborne beryllium generated from re-suspending 
beryllium from surfaces, even with some beryllium surface levels above 
0.2 g/100 cm\2\, would be expected to be well below the EPA's 
National Emission Standards for Hazardous Air Pollutants (NESHAP) limit 
of 0.01 g/m\3\ and therefore, at safe levels. EPA's NESHAP is 
the national standard for community air that the population 
continuously breathes.
    DOE has addressed the concerns of commenters (Exs. 46, 50) that it 
may not be possible to clean equipment and other items to below the 
natural background of beryllium in local soil. It is highly unlikely 
that this rule would apply to soil because soils generally contains 
less than 0.1 percent beryllium and, therefore, is not considered 
beryllium for the purposes of this rule. Nonetheless, DOE included in 
section 850.31(b)(3) the words ``or the concentration level of 
beryllium in local soil at the point of release'' to eliminate the 
possibility that the rule would compel a responsible employer to clean 
local soil off of equipment and other items before release.
    DOE does not agree with the view of some commenters that, in the 
absence of scientific evidence of a threshold or ``safe'' level of 
exposure to beryllium, the surface contamination release level should 
be at the limit of detection or zero. Although one commenter (Ex. 45, 
45B) submitted information indicating that re-suspension of beryllium 
in the air is possible on surfaces with less than 1.0 g/100 
cm\2\ of beryllium, there currently is no scientific evidence that 
surfaces cleaned to that level would result in airborne concentrations 
of beryllium at levels that would be harmful to workers.
    DOE has addressed the concern about the potential for exposure to 
re-suspended beryllium by requiring a case-by-case assessment of risk 
before equipment and other items are released for non-beryllium uses. 
There is likely to be wide variation in these situations, and DOE is 
not prepared at this time to prescribe uniform management controls. 
However, this is an area for which DOE may develop guidance to assist 
field elements, as experience is gained under this rule.
    One commenter (Ex. 43) recommended establishing a general surface 
release level of 1 g/100 cm\2\, plus labeling of items. The 
commenter suggested the use of labels to shift responsibility for 
controlling future exposures to the recipients of the equipment or 
items. DOE does not believe that simply cleaning the outside of the 
equipment and other items and providing warning to the new user is 
adequate because some recipients, particularly recipients who have not 
performed work using beryllium, may not fully understand the risks 
associated with beryllium exposure.
    Release for beryllium work. Section 850.31(c)(1) sets the 
contamination level for equipment or other items released for use in 
other facilities engaged in beryllium work at 3 g/100 cm\2\. 
The equipment or item also must be labeled in accordance with section 
850.38(b). Section 850.31(c)(3) requires the responsible employer to 
ensure that a released item is enclosed or placed in sealed, 
impermeable bags or containers to prevent exposure to beryllium during 
handling and transportation to its destination. Enclosure of equipment 
and other items to be released to other beryllium operations can be 
accomplished by any practical means, such as wrapping in plastic.
    Several commenters recommended that DOE establish a higher surface 
contamination release level for equipment and other items to be 
transferred to another facility for beryllium work than is allowed for 
items released to the public or for use in DOE non-beryllium work (Exs. 
38, 41, 42, 46, 51). Surface contamination levels recommended by the 
commenters (see Table 9) for release of equipment and other items to be 
used in beryllium areas range from 0 and non-detectable to 10 
g/100 cm\2\. Rocky Flats (Ex. 47) previously established a 
release level for equipment and other items to be transferred to other 
DOE facilities for beryllium work at 2.5 g/100 cm\2\. Several 
commenters (Exs. 41, 42, 51) and a number of the DOE sites reporting 
release levels support the use of 3 g/100 cm\2\ or less as a 
release level for equipment and other items that will be used for 
beryllium work.
    Based upon current surface sampling technology, DOE sees no 
appreciable difference between 2.5 g/100 cm\2\ and 3 
g/100 cm\2\ and, therefore, has adopted the 3 g 100 
cm\2\ value for release of equipment and other items to other 
facilities for beryllium work. Adoption of this value also maintains a 
consistency with the housekeeping requirements for operational 
beryllium areas, which will simplify implementation by DOE facilities.
    Other issues. One commenter (Ex. 51) recommended that the rule 
specify that an industrial hygienist should determine the number and 
location of swipe samples. DOE views the determination of the number 
and location of swipe samples to be part of the hazard assessment, 
which must be managed by a qualified individual such as a CIH (see 
discussion for section 850.21).

[[Page 68888]]

    Two commenters (Exs. 49, 50) were concerned with dermal exposures 
to beryllium. DOE agrees that there is a potential health hazard 
associated with dermal exposure to beryllium, and has imposed 
requirements under sections 850.29 and 850.37 to protect workers 
handling beryllium. The hazards associated with dermal exposures also 
are dealt with in the DOE facilities' health and safety programs under 
DOE Order 440.1A or, analogous Orders or standards cited in responsible 
employers' contract with DOE.

Section 850.32--Waste Disposal

    Section 850.32 (proposed as section 850.31) establishes the waste 
disposal provisions of the CBDPP. Like many of the provisions of the 
rule (e.g., regulated areas, protective clothing and equipment, and 
housekeeping), the waste disposal provisions are designed to minimize 
the spread of beryllium contamination throughout the facility or beyond 
the sites boundaries.
    DOE believes that the most effective way to control the spread of 
contamination resulting from waste disposal activities is to prevent or 
minimize the generation of beryllium waste. Accordingly, section 
850.32(a) of the final rule requires responsible employers to employ 
waste minimization principles in conducting beryllium activities. Good 
housekeeping practices, required by section 850.30, aid in this effort 
by continually removing beryllium dust accumulations from work 
surfaces, thereby reducing the level of contamination of workplace 
equipment. The performance of hazard analyses on operations with the 
potential to generate wastes, as required by section 850.21, can help 
responsible employers identify potential sources of wastes and evaluate 
possible controls that could be implemented to prevent or reduce waste 
generation. Other waste minimization practices, such as minimizing the 
equipment and material that is exposed to beryllium contamination, will 
also assist in reducing the amount of material that must be disposed of 
as beryllium or beryllium-contaminated waste, thus reducing the 
potential beryllium exposure hazards.
    Section 850.32(b) of the final rule requires responsible employers 
to dispose of beryllium-containing waste, and beryllium-contaminated 
equipment and other items that are disposed of as waste, in sealed 
impermeable bags, containers, or enclosures that are labeled in 
accordance with section 850.38. Enclosure can be any practical 
mechanism for sealing, such as wrapping in plastic. DOE believes these 
waste disposal provisions are necessary to prevent the re-suspension of 
beryllium contamination into the workplace atmosphere. Warning labels 
are necessary to ensure that workers are aware that bags, containers, 
or enclosures contain beryllium so that they can take appropriate 
precautions. Furthermore, responsible employers must comply with 
applicable Federal, state, and local regulations governing the 
management, transportation, and disposal of waste that contain 
beryllium.
    DOE received two comments regarding the waste disposal provisions 
of the NOPR. One commenter (Ex. 31) applauded DOE for including waste 
minimization principles as a control measure for reducing beryllium 
exposures. This commenter suggested that DOE consider developing a non-
mandatory appendix to the rule or stand-alone guidance to illustrate 
waste minimization principles and provide ideas for workers and 
employers. DOE recognizes the utility of non-mandatory guidance in 
assisting responsible employers in implementing certain mandatory 
requirements of the CBDPP. DOE notes, however, that the U.S. 
Environmental Protection Agency and other Federal agencies have already 
developed a wide variety of guidance materials addressing waste 
management, waste minimization, and pollution prevention principles and 
practices. Not only are these guides readily available to the DOE 
community, but many DOE sites have used these guides to develop their 
own hazardous waste management plans. For this reason, DOE believes 
that the development of an additional guidance document to address 
waste minimization principles for the final CBDPP rule is not 
necessary. DOE is developing an implementation guide for the CBDPP rule 
that will provide general guidance for disposal of beryllium waste.
    The other commenter (Ex. 18) suggested that the waste disposal 
provisions should address the declassification of beryllium parts that 
are classified for national security purposes at certain DOE sites. 
This section of the final rule requires responsible employers to 
control the generation of beryllium-containing waste, and beryllium-
contaminated equipment and other items that are disposed of as waste 
and to dispose of this equipment and other items in a safe manner. DOE 
does not intend for these provisions to alter or affect the 
classification of beryllium-contaminated equipment and other items, nor 
to supersede the applicable requirements for protection of such 
equipment and items. Accordingly, beryllium-contaminated materials that 
are classified must be handled in accordance with the governing 
national security regulations, standards, and policies. Responsible 
employers also must dispose of such materials in accordance with the 
provisions of this rule.

Section 850.33--Beryllium Emergencies

    Section 850.33 (proposed as section 850.32) establishes the 
beryllium-related emergency provisions of the CBDPP. Such provisions 
are particularly important in light of the possibility, suggested by 
several commenters, that a single, high-level beryllium exposure may 
have been the cause of CBD occurring among several workers thought to 
have had no exposure or only incidental, low-level exposures to 
beryllium.
    Proposed section 850.32 would have established broad performance-
based provisions requiring responsible employers to develop procedures 
for responding to and alerting workers to beryllium emergencies, to 
ensure the availability and use of appropriate protective equipment 
during related cleanup operations, and to provide emergency response 
workers with appropriate training on proper response procedures.
    Two commenters (Exs. 11, 31) responded to the proposed beryllium 
emergencies section, and both requested that DOE provide additional 
guidance regarding beryllium emergency procedures, training, and 
personal protective equipment requirements. One commenter (Ex. 31) 
suggested that this guidance was needed to ensure a consistent and 
coordinated response to beryllium emergencies in cases in which workers 
from different employers respond to the same event. Both commenters 
suggested that DOE consider incorporating elements of the emergency 
response provisions of OSHA's Hazardous Waste Operations and Emergency 
Response standard (29 CFR 1910.120) in the CBDPP rule.
    DOE agrees with the commenters, and notes that the beryllium 
emergencies provisions of the NOPR were not intended to supersede the 
applicable provisions of 29 CFR 1910.120. Accordingly, to avoid 
confusion and duplicative efforts and to ensure consistent and 
coordinated responses to beryllium emergencies at DOE facilities, DOE 
has revised the beryllium emergencies section (renumbered section 
850.33 in the final rule) to require responsible employers to comply 
with 29 CFR 1910.120(l) for

[[Page 68889]]

emergency response activities related to hazardous waste cleanup 
operations, and 29 CFR 1910.120(q) for emergency response activities 
related to all other operations. Also, DOE will provide general 
guidance on preparing for, and responding to, emergencies involving 
beryllium in the DOE implementation guide for this rule.

Section 850.34--Medical Surveillance

    Section 850.34 (proposed as section 850.33) establishes the medical 
surveillance provisions of the CBDPP. These provisions are aimed at: 
(1) Identifying workers at higher risk of adverse health effects from 
exposure to beryllium; (2) preventing beryllium-induced disease by 
linking health outcomes to beryllium tasks; and (3) making possible the 
early treatment of beryllium-induced disease.
    Several changes have been made to the medical surveillance 
provisions as proposed. These changes include enlarging the scope of 
the covered population to include former beryllium workers who are 
still employed at DOE facilities in non-beryllium work; adding the term 
``beryllium-associated worker,'' which includes all current workers who 
have or had the potential for exposure to beryllium; adding a multiple 
and alternate physician review process; deleting the requirement that 
exposure be at or above the action level before initiating medical 
surveillance; and deleting the requirement for Office of Environment, 
Safety and Health review of the written medical surveillance program. 
In addition, DOE has made editorial changes to clarify various 
provisions.
    The medical surveillance program is designed to ensure the prompt 
identification, and makes possible the proper treatment, of workers who 
become sensitized to beryllium or develop CBD. In addition to 
determining the incidence of CBD in the workforce, the medical 
surveillance program fulfills a critical information development 
function, including identifying the risk factors associated with the 
development of CBD and beryllium sensitization. This rule requires that 
medical surveillance be given to workers who are at the greatest risk 
from continued exposure. This determination should be made on the basis 
of the air monitoring results, the SOMD's recommendation, and any other 
relevant information the responsible employer may possess, such as past 
medical or air monitoring records, workers' job tenure, etc.
    DOE realizes that some workers may elect not to participate in the 
medical surveillance program because they believe that a diagnosis of 
CBD or beryllium sensitization could have a negative impact on future 
employment opportunities or on their health insurance. In light of this 
concern and DOE's desire to maximize worker participation in the 
medical surveillance program, DOE in the NOPR requested interested 
parties to comment on the feasibility and utility of including 
anonymous testing as a provision in the final rule. In requesting 
public comment, DOE noted two concerns it had regarding the use of 
anonymous testing; specifically, concern about DOE's inability to 
correlate collected exposure data to health outcomes for workers 
choosing anonymous testing, and concern about the effect of anonymous 
testing on DOE's ability to conduct follow-up tests to confirm positive 
Be-LPT results.
    Eight commenters (Exs. 4, 16, 17, 23, 26, 28, 30, 31) responded to 
DOE's request for information regarding anonymous testing. Most 
commenters stated that anonymous testing would not provide significant 
additional benefits or protection for workers. In addition, all of the 
commenters shared DOE's concerns regarding the resulting inability to 
correlate collected exposure data to health outcomes, and the 
difficulty of tracking employees for follow-up testing to confirm 
positive results. The commenters believed that these two drawbacks 
overshadow any potential increase in worker participation.
    One commenter (Ex. 17) expressed concern that the use of anonymous 
testing would limit the employer's ability to provide support to 
workers receiving medical surveillance. This commenter noted that 
ongoing support and reassurance is essential for those workers with 
positive or inconclusive test results. Three commenters (Exs. 16, 23, 
26) stated that medical surveillance should be used to determine 
workplace exposures and evaluate the effectiveness of workplace 
controls. These commenters believe that anonymous testing would hamper 
this effort by preventing responsible employers from identifying 
specific jobs or tasks that lead to beryllium-related health effects.
    For reasons stated in the NOPR and expressed by all eight 
commenters, DOE has decided against the use of anonymous testing. 
However, DOE has taken steps in the final rule to protect the privacy 
of beryllium-associated workers, e.g., by requiring the use of unique 
identifiers (see discussion of section 850.39). DOE cannot responsibly 
accomplish the tasks of ameliorating the effects of exposure to 
beryllium and developing needed data on the cause and development of 
CDB through anonymous testing. DOE also believes that offering 
anonymous testing as a supplement to identified testing would 
discourage workers from participating in identified testing. 
Accordingly, provisions for anonymous testing are not included in the 
final beryllium rule.
    Section 850.34(a)(1) requires responsible employers to establish 
and implement a medical surveillance program for beryllium-associated 
workers. DOE adheres to its view that participation in the medical 
surveillance program should not be mandatory for workers. The 
responsible employer's obligation is to offer to provide the medical 
tests and procedures as required. DOE expects that where worker 
confidence in the medical program exists, refusal to participate will 
be minimal.
    The term ``beryllium-associated worker'' is used in the final rule 
where DOE has determined that coverage of provisions should not be 
limited to current workers regularly employed in DOE beryllium 
activities. Use of the term ``beryllium-associated worker'' will 
increase the population eligible to receive medical surveillance by 
including current workers with past beryllium exposures or potential 
for exposures.
    Numerous commenters (Exs. 2, 3, 4, 14, 16, 17, 28, 30, 29, 31) made 
recommendations regarding the level of employee exposure that should 
trigger worker participation in the medical surveillance program. Two 
of these commenters (Exs. 3, 4) objected to offering medical 
surveillance to all workers potentially exposed to beryllium. However, 
their reasons for not wanting to include all potentially exposed 
workers differed. One commenter (Ex. 3) stated that placing all 
potentially exposed employees in the medical surveillance program would 
be inconsistent with the permissible exposure limit. The other 
commenter (Ex. 4) was concerned with the costs associated with such a 
strategy, and the potential for causing worker anxiety from false-
positive Be-LPT test results for workers with limited exposure 
potential. While these commenters agreed that some level of worker 
beryllium exposure should trigger the medical surveillance program, 
neither provided recommendations for an appropriate trigger level.
    One commenter (Ex. 16) suggested that DOE use a graded approach to 
the medical surveillance program which would include current beryllium 
workers and other workers with exposures or potential exposures at or 
above the action level. DOE has

[[Page 68890]]

determined that a graded approach linked to exposure at or above the 
action level would not ensure the necessary surveillance of all DOE and 
contractor workers who may have had exposure to beryllium, whether 
current or past.
    Several commenters (Exs. 2, 14, 16, 17, 28, 29, 30, 31) favored the 
inclusion of all potentially exposed workers in the medical 
surveillance program regardless of the measured exposure level. These 
commenters argued that medical surveillance should not be limited to 
workers exposed to levels of beryllium at or above the action level, 
but rather should include all workers with the potential for any 
beryllium exposure. Three of these commenters stated that current 
scientific evidence does not indicate a ``safe'' level of beryllium 
exposure, and that CBD has been identified in individuals thought to 
have only low or incidental exposure to beryllium. Their concern was 
that restricting medical surveillance to ``beryllium workers,'' as 
defined in proposed section 850.3, would exclude such workers, who in 
their view are also at risk of contracting CBD. In addition, two of the 
commenters (Exs. 28, 30) noted that allowing workers exposed at any 
level to participate in the medical surveillance program would act as 
an incentive for employers to minimize the number of individuals who 
work in beryllium areas.
    Similarly, three commenters (Exs. 28, 29, 31) argued that current 
workers with past beryllium exposures should be offered the opportunity 
to participate in the medical surveillance program. One commenter (Ex. 
31) noted that, based on the proposed definition of ``beryllium 
worker,'' medical surveillance would not be made available to current 
workers with past beryllium exposure unless they were covered under the 
medical removal provisions of proposed section 850.34. Another 
commenter (Ex.15) suggested that all employees at DOE facilities, even 
those with no exposure to beryllium, should be given the option of 
participating in the medical surveillance program.
    Several commenters (Exs. 2, 16, 28, 31, 19) raised the issue of 
medical surveillance for former workers with past beryllium exposures 
who no longer work at a DOE facility. The commenters stated that former 
DOE workers should also be provided the opportunity to participate in 
medical monitoring. They acknowledged DOE's proposed establishment of a 
separate, directly funded program that offers medical examinations to 
former workers at risk of developing CBD. However, two of the 
commenters (Exs. 16, 31) argued that this program should be made 
available to former workers at the same time as the program for current 
workers. Another commenter argued that maintaining two separate 
databases and programs was not practical.
    DOE has revised the final rule to require responsible employers to 
provide medical surveillance for all beryllium-associated workers. DOE 
based this revision on the beryllium cases suggesting that low and even 
incidental exposure to beryllium can lead to sensitization or beryllium 
disease. This approach will ensure the early identification of workers 
at risk of health effects from exposure to beryllium, provide the 
greatest protection of worker health, and provide a more complete 
documentation of beryllium exposures. Beryllium-associated workers 
eligible for medical surveillance include any current worker who is 
exposed or was exposed or potentially exposed to airborne 
concentrations of beryllium at a DOE facility. Thus medical 
surveillance will be available to a beryllium worker (as defined in 
section 850.3), a current worker whose work history shows that the 
worker may have been exposed to airborne concentrations of beryllium at 
DOE facilities, a current worker who exhibits signs and symptoms of 
beryllium exposure, and a worker who is receiving medical removal 
protection benefits.
    Section 850.34(a)(2) requires responsible employers to designate a 
Site Occupational Medical Director (SOMD) who will be responsible for 
administering the medical surveillance program. One commenter (Ex. 18) 
stated that a panel comprised of individuals representing management, 
labor, the public, and the local medical community should select the 
SOMD. DOE has not adopted this recommendation because DOE believes that 
the responsible employer must have ultimate responsibility for ensuring 
compliance with this requirement.
    A number of commenters (Exs. 12, 14, 20, 23) were concerned about 
the quality of health care for workers with CBD and, more specifically, 
whether or not workers would have a choice of physicians. One commenter 
(Ex. 20) pointed out that OSHA no longer restricts the performance of 
medical evaluations to licensed physicians because this requirement is 
too prescriptive and fails to recognize the realities of today's health 
care system. This commenter suggested adding a provision to include 
other licensed health care professionals among those who may perform 
medical evaluations.
    DOE agrees with this commenter and has revised section 850.34(a)(3) 
of the final rule to require responsible employers to ensure that all 
medical evaluations and procedures are performed by or under the 
supervision of a licensed physician who is familiar with the health 
effects of beryllium. Although a licensed physician is the appropriate 
person to supervise and evaluate a medical evaluation, certain required 
elements of the evaluation may be performed by another, appropriately 
qualified person under the supervision of the physician. The licensed 
physician is required to be familiar with the health effects of 
beryllium. DOE expects that the medical evaluations and procedures 
required to diagnose CBD will be performed or validated by a specialist 
in pulmonary medicine, occupational medicine, or other physician with 
specialized equipment and examination protocols required to 
definitively differentiate between CBD and other lung diseases. DOE 
believes that this is necessary due to the unusual nature of CBD and 
the fact that not all physicians are familiar with the evaluation of 
beryllium-associated patients.
    Three commenters (Exs. 15, 18, 22) expressed concern about certain 
language in the NOPR preamble that they interpreted to mean that 
workers would be limited to an evaluation performed by an employer's 
physician. One commenter (Ex. 22) suggested that DOE adopt OSHA's Lead 
Standard as a model for selecting physicians. DOE never intended to 
limit an employee's choice of physicians. To clarify this point, DOE 
has included in section 850.34, paragraphs (c) and (d), provisions for 
a multiple physician and alternate physician review. These provisions 
are explained in the discussion that follows.
    DOE views medical surveillance as a primary tool for determining 
the extent of CBD risk within the worker population. Therefore, section 
850.34(a)(4) requires responsible employers to maintain and give to the 
SOMD a list of beryllium-associated workers who may be eligible for 
medical surveillance. The list must be based on hazard assessments, 
exposure records, and any other information that will identify 
beryllium-associated workers (section 850.34(a)(4)(i)). In addition, 
section 850.34(a)(4)(ii) requires responsible employers to regularly 
update the list based on the information from the periodic evaluations 
performed pursuant to paragraph (b)(2) of this section.
    One commenter (Ex. 16) questioned why DOE proposed to give the SOMD 
the task of identifying working conditions that contribute to the risk 
of CBD and determining the need for

[[Page 68891]]

additional exposure controls. This commenter believed that this task 
should be performed by an industrial hygienist. Similarly, another 
commenter (Ex. 23) stated that the SOMD should not be responsible for 
performing data analysis to determine which workers should be included 
in the medical surveillance program, or for maintaining the list of 
beryllium workers at a site. The commenter argued that both of these 
tasks are management functions that should be carried out by the 
responsible employer based on technical guidance provided by the 
industrial hygiene department and the SOMD. DOE agrees with both of 
these commenters. The responsible employer, not the SOMD, should have 
the function of identifying working conditions and evaluating the need 
for workplace controls. Consequently, DOE has revised the final rule to 
require that responsible employers identify beryllium-associated 
workers. However, medical judgments that are requisite to management 
decisions are the SOMD's responsibility.
    Section 850.34(a)(5) requires the responsible employer to provide 
the SOMD with the information needed to operate and administer the 
medical surveillance program. This information includes, but is not 
limited to, the baseline beryllium inventory, hazard assessment 
results, and exposure monitoring data, as well as information regarding 
the identity and nature of activities or operations on the site that 
are covered under the CBDPP, the related duties of beryllium workers, 
and the types of personal protective equipment employed in the 
performance of these duties.
    Section 850.34(a)(6) requires the responsible employer to provide 
the SOMD and the examining physician with (1) A copy of this rule and 
its preamble; (2) a description of the workers' duties as they pertain 
to beryllium exposure; (3) records of the workers' beryllium exposure; 
and (4) a description of personal protective and respiratory protective 
equipment in current or anticipated use. DOE believes that this 
information is necessary to ensure that the physician can make informed 
decisions regarding the required content of the medical evaluation and 
the subsequent development of recommendations related to each 
beryllium-associated worker.
    Several commenters (Ex. 8, 17, 18, 19) suggested including 
provisions for providing beryllium education and training programs to 
physicians and other health care providers in the rule. DOE has not 
adopted this suggestion, because it would expand the scope of the rule.
    Section 850.34(b) requires responsible employers to provide, 
without cost to beryllium-associated workers, all medical evaluations 
and procedures performed to comply with these regulations. This section 
also requires that all evaluations and procedures be performed at a 
time and place that are convenient for the worker. This provision is 
consistent with similar provisions in OSHA's expanded health standards. 
This section also requires responsible employers to provide the SOMD 
with a list of beryllium-associated workers who may be eligible for 
protective measures under the rule.
    Section 850.34(b)(1) requires responsible employers to provide a 
baseline medical evaluation to beryllium-associated workers. The 
purpose of the baseline medical evaluation is to: (1) Establish the 
current health status of the worker and determine whether it is 
appropriate to assign the worker to jobs with beryllium exposure; (2) 
initially determine what level of medical surveillance the responsible 
employer must provide to the worker; and (3) establish essential 
baseline data for the worker which is used to assess subsequent health 
changes attributable to beryllium exposure.
    DOE received a number of comments regarding baseline medical 
evaluations and medical testing. One commenter (Ex. 25) requested 
clarification as to the differences between pre-placement exams, as 
specified in DOE Notice 440.1, ``Interim Chronic Beryllium Disease 
Prevention Program,'' and the baseline exams specified in the NOPR. The 
final rule will supersede DOE Notice 440.1, and the interim medical 
surveillance program requirements will be replaced with those of the 
final rule. The final rule does not refer to pre-placement exams. 
Another commenter (Ex. 23) recommended that the meaning of spirometry 
be clarified to ensure consistency. DOE agrees and has specified the 
measurement of forced vital capacity (FVC) and forced expiratory volume 
at 1 second (FEV 1) in section 850.34(b)(1)(v) of the final 
rule.
    A commenter (Ex. 19) questioned the value of baseline pulmonary 
function tests and x-rays. This commenter suggested that baseline 
studies cannot be used to determine which health changes are related to 
work hazards and which are related to other activities or disease 
processes. This commenter favored the approach of following patients 
clinically and using Be-LPT and other studies, to augment clinical 
impressions. Early identification of CBD, this commenter states, might 
have no positive effect on the course of the disease.
    DOE disagrees with this comment. Early identification and 
intervention are important for identifying workers at higher risk of 
exposure to beryllium, and for preventing and minimizing the effects of 
beryllium-induced disease. DOE's position is supported by a commenter 
(Ex. 29) who stated that while spirometry and X-rays may not be 
predictive, X-rays have in some instances identified CBD cases in 
individuals who had a normal Be-LPT. This commenter stated that these 
cases are likely to be missed if spirometry and X-rays are not 
required, and also recommended X-ray screening for Be-LPT negative 
individuals with persistent chest problems. Another commenter (Ex. 19) 
emphasized the benefits of good data collection to determine if early 
removal of beryllium sensitized workers prevents the progression to 
CBD.
    One commenter (Ex. 33) suggested that, if available, recent chest 
X-rays be utilized for the baseline medical evaluation to reduce X-ray 
exposure. DOE agrees that if previous chest X-rays have been conducted, 
for a baseline beryllium evaluation, additional X-rays should not be 
used unless specified by a physician. However, to ensure that the chest 
X-ray correlates with other diagnostic and historical information, only 
those X-rays taken for the purpose of a baseline beryllium evaluation 
or equivalent evaluation should be used to establish a baseline.
    Section 850.34(b)(1)(vi) requires responsible employers to provide 
a Be-LPT as part of the baseline evaluation. The Be-LPT is the only 
available laboratory test for determining individual immune response to 
beryllium in vitro. Its use in a surveillance program will permit 
detection of beryllium-related health effects at a pre-clinical stage. 
A positive Be-LPT would indicate the need for further evaluation to 
determine the presence of CBD. The use of the Be-LPT as an evaluation 
tool provides an early opportunity for diagnosis and treatment of CBD.
    Finally, section 850.34(b)(1)(vii) authorizes the examining 
physician to make available to the worker any additional tests deemed 
medically necessary. DOE believes that it is important that the 
examining physician have such discretion because individuals may 
exhibit different responses to beryllium. In this regard, one commenter 
(Ex. 16) expressed concern regarding proposed section 850.33(i), which 
provided that workers

[[Page 68892]]

would be referred for further diagnostic evaluation if there were two 
or more positive Be-LPTs. The commenter interpreted this provision as a 
mandatory requirement. DOE's intent is that workers have the 
opportunity for additional testing if recommended by the examining 
physician. A worker is not required by the rule to undergo additional 
medical evaluation and treatment.
    One commenter (Ex. 29) recommended clinical referral for additional 
diagnostic tests after one positive Be-LPT, instead of two or more as 
proposed by DOE. DOE believes that the examining physician is in the 
best position to determine which additional tests, if any, would be 
useful in evaluating the health of an individual worker. Therefore, DOE 
has removed the requirement for follow-up testing based on two or more 
positive Be-LPT tests, relying instead on the examining physician's 
discretion under section 850.34(b)(1)(vii) to order follow-up tests 
when appropriate.
    Section 850.34(b)(2) requires responsible employers to provide 
medical evaluations to beryllium workers annually, and to other 
beryllium-associated workers every 3 years. Responsible employers must 
provide the periodic medical evaluation elements described in section 
850.34(b)(2)(i) to detect, at an early stage, any pathological changes 
that could lead to CBD or be aggravated by beryllium exposure. By 
detecting abnormalities early, workers may be medically removed to 
prevent further beryllium exposure.
    Section 850.34(b)(2)(ii) requires responsible employers to provide 
to beryllium-associated workers a chest radiograph (X-ray) every 5 
years. DOE includes this requirement for periodic X-rays because X-rays 
have been shown to be effective in the early detection of beryllium-
related health effects (Ex. 29).
    Following an emergency in which a worker, who is not already 
participating in the beryllium medical surveillance program, is exposed 
to an elevated amount of beryllium, the responsible employer is 
required by section 850.34(b)(3) to provide a medical evaluation as 
soon as possible.
    A commenter (Ex. 23) suggested that a standard respiratory symptom 
questionnaire, medical work history form, and physical examination form 
be used at all DOE sites for consistency. DOE agrees that such 
standardized forms may help ensure consistency across the DOE complex, 
but is concerned that mandating the use of standardized forms may limit 
the discretion of the SOMD in determining the appropriate medical 
surveillance for each individual. Accordingly, DOE has decided to 
include appropriate standardized forms as non-mandatory guidance in an 
implementation guide to accompany the final rule. Another commenter 
(Ex. 29) was concerned that the NOPR required a respiratory symptom 
questionnaire for periodic medical evaluations, but not for the 
baseline evaluation. DOE acknowledges this oversight and has included 
the respiratory symptom questionnaire as part of both the periodic and 
baseline medical evaluations in sections 850.34(b)(1)(ii) and 
(b)(2)(I)(B) of the final rule.
    Section 850.34(c) requires responsible employers to establish a 
multiple physician review process for affected beryllium-associated 
workers. DOE has identified three benefits of providing a multiple 
physician review process: (1) to strengthen and broaden the bases for 
medical decisions made pursuant to this rule when a beryllium-
associated worker questions the findings, recommendations, or 
determinations of an initial physician retained by the responsible 
employer; (2) to increase beryllium-associated workers' confidence in 
the soundness of medical findings, recommendations and determinations 
made under this rule; and (3) to increase beryllium-associated worker's 
acceptance of, and participation, in the medical surveillance program.
    Given the shortage of trained and experienced occupational 
physicians, it is possible that some physicians performing examinations 
or consultations under the beryllium rule will misdiagnose CBD. 
However, rather than requiring multiple medical opinions in all cases, 
which would be expensive and potentially wasteful, DOE is providing to 
beryllium-associated workers an opportunity to obtain an independent 
review of the findings, determinations or recommendations of the 
physician selected by the responsible employer. Over time, this 
independent review is likely to show either that a perceived low level 
of confidence in the physician retained by the responsible employer is 
unwarranted, or that the responsible employer should improve the 
quality of the medical surveillance being provided. In either case, the 
multiple physician review process will have served a beneficial 
purpose.
    In section 850.34(c)(1), a beryllium-associated worker may 
designate a second physician to review any findings, determinations, or 
recommendations of the physician chosen by the responsible employer, 
and to conduct such examinations, consultations, and laboratory tests 
as the second physician may deem necessary to facilitate this review. 
The responsible employer's obligation to provide information to the 
examining physician extends to other physicians involved in the 
multiple physician review or alternate physician review process so that 
all of the physicians involved will have an equal opportunity to assess 
the beryllium-associated worker's health status.
    Section 850.34(c)(2) requires that after an initial physician 
conducts an examination or consultation, the responsible employer must 
promptly notify the worker of his or her right to seek a second medical 
opinion. This notification must be in writing.
    Section 850.34(c)(3) requires that after the worker is notified of 
this right, the responsible employer may condition its participation 
in, and payment for, multiple physician review upon the worker, within 
15 days after receipt of the notification or the initial physician's 
written opinion, whichever is later, both (1) informing the responsible 
employer that the worker intends to seek a second medical opinion, and 
(2) initiating steps to make an appointment with a second physician.
    The rule contains no limitation on a beryllium-associated worker's 
choice of a second physician, except the requirement in section 
850.34(a)(3) that the second physician must be a licensed physician who 
is familiar with the health effects of beryllium.
    If the second physician's findings, determinations, and 
recommendations are the same as those of the initial physician, then 
the multiple physician review process comes to an end. However, as 
provided in section 850.34(c)(4), if the opinions of the two physicians 
are in conflict, then the responsible employer and the beryllium-
associated worker must undertake to encourage the two physicians to 
resolve any disagreement. DOE expects that the two physicians will 
communicate with each other to resolve their differences, but the rule 
requires the responsible employer and worker to encourage such a 
resolution. In most cases, this professional interaction should resolve 
any differences of opinion.
    In cases where differences remain, these differences of opinion are 
likely to be genuine and substantial. If the first two physicians are 
unable to resolve expeditiously any differences of opinion with respect 
to a beryllium-associated worker, then it is necessary for a third 
qualified physician to resolve the dispute. It is critical that this 
third

[[Page 68893]]

physician has the confidence of those concerned and is competent to 
resolve the dispute. Consequently, section 850.34(c)(5) requires that 
the responsible employer and the beryllium-associated worker together, 
through their respective physicians, must designate the third 
physician.
    Under section 850.34(c)(5) the third physician will have a full 
opportunity to review the findings, determinations, and recommendations 
of the two prior physicians, and to conduct such examinations, 
consultations and laboratory tests as the third physician deems 
necessary. DOE's expects that the third physician will consult with the 
other two physicians. The third physician should provide a written 
medical opinion to the SOMD which will be used to resolve the 
disagreement between the other two physicians. Section 850.34(c)(6) 
requires the SOMD to act in a manner consistent with the findings, 
determinations, and recommendations of the third physician, unless the 
SOMD and the beryllium-associated worker reach an agreement that is 
otherwise consistent with the recommendations of at least one of the 
other two physicians.
    Since the multiple physician review process will be a means by 
which medical surveillance is provided to a beryllium-associated 
worker, responsible employers must bear the expense of this process 
when it is used. Based on OSHA's practice and experience with multiple 
physician review in its health standards, DOE does not expect the costs 
of this process to be burdensome to the responsible employers. If 
responsible employers establish and administer medical surveillance 
programs that engender worker confidence, workers should have little or 
no need to seek second medical opinions.
    The requirement for multiple physician review is not intended to 
preclude responsible employers from establishing and implementing 
alternate medical protocols. DOE has included language in section 
850.34(d) to provide for alternate physician determination. Under that 
section, the responsible employer and beryllium-associated worker, or 
the worker's designated representative, may agree upon the use of any 
expeditious alternate physician determination process, instead of the 
multiple physician review process. The only condition is that the 
alternate process be no less protective of the worker's health than the 
multiple review process. For example, a jointly agreed upon physician 
might be used in the first instance without recourse to other 
physicians. DOE encourages responsible employers and workers to adopt 
medical determination procedures in which all parties have trust and 
confidence.
    Section 850.34(e)(1) requires the SOMD to provide to responsible 
employers, within two weeks after receipt of results, a written and 
signed medical opinion after each medical evaluation of a beryllium-
associated worker. The purpose of requiring the SOMD to give the 
responsible employer a written opinion is to inform the responsible 
employer of the medical basis for determining the job placement of the 
examined worker. This written medical opinion, as described in section 
850.34(e)(i-iii), must contain any diagnosis of the worker's condition 
related to occupational exposure to beryllium; any other detected 
medical conditions relevant to further beryllium exposure; any 
recommended restrictions on the worker's exposure to beryllium or on 
the use of protective clothing or equipment; and a statement indicating 
that the SOMD or the examining physician has provided to the worker the 
results of the test, the medical evaluation, including all tests 
results and any medical condition related to beryllium exposure that 
requires further evaluation or treatment.
    Section 850.34(e)(2) requires the SOMD to withhold from the 
responsible employer, orally or in the written medical opinion, 
specific findings or diagnoses not related to occupational exposure to 
beryllium.
    Two commenters (Ex. 23, 28) expressed concern regarding proposed 
section 850.33(j)(2), which stipulated that the physician's written 
medical reports be delivered within 15 calendar days after the 
completion of a medical evaluation. The commenters noted that Be-LPT 
tests are time-consuming and may exceed the 15-day time frame, and 
suggested that the 15-day period should begin after receipt of the test 
results. DOE agrees, and has revised section 850.34(f) to require the 
SOMD to give beryllium-associated workers a written medical opinion 
containing the results of all medical tests or procedures, an 
explanation of any abnormal findings, and any recommendation that the 
worker be referred for additional testing within 10 working days after 
the SOMD's receipt of test results.
    In section 850.34(f)(2), upon request by the beryllium-associated 
worker, the responsible employer is required to provide the worker with 
a copy of the information the responsible employer is required to 
provide to the examining physician.
    Section 850.34(g) requires the responsible employer to report on 
the applicable OSHA reporting form (currently OSHA Form No. 200) 
beryllium sensitization, CBD, or any other abnormal condition or 
disorder of workers caused or aggravated by occupational exposure to 
beryllium. Although not included in the proposed rule, this provision 
reflects current practices and does not impose a new burden on 
employers. Reporting abnormal conditions and disorders that are 
occupationally caused and beryllium-related will contribute to the 
development of occupational health statistics that eventually may lead 
to improved disease prevention and medical intervention for beryllium-
associated workers. It will also provide DOE with information and data 
helpful in assessing the effectiveness of the CBDPP rule and in 
considering what, if any, modification should be made to the rule in 
the future.
    Section 850.34(h)(1) requires responsible employers to establish a 
routine and systematic analysis of medical, job, and exposure data. The 
purpose of this requirement is to collect and analyze information so 
that the prevalence of disease can be accurately described and 
conclusions reached on causes or risk factors for the disease. This 
data analysis is an effective means of measuring performance under the 
CBDPP, and for correcting and improving the CBDPP. Section 850.34(h)(2) 
requires the responsible employer to use the results of these analyses 
to determine which workers should be offered medical surveillance and 
the need for additional exposure controls.
Section 850.35--Medical Removal
    Section 850.35 (proposed as section 850.34) requires responsible 
employers to establish medical removal protection (MRP) and medical 
removal protection benefits (MRPB) as part of the CBDPP.
    Medical surveillance can only be effective in detecting and 
preventing disease if beryllium-associated workers: (1) voluntarily 
seek medical attention when they feel ill; (2) refrain from efforts to 
conceal their true health status; and (3) fully cooperate with 
examining physicians to facilitate accurate medical diagnoses and 
effective treatment. This sort of worker participation and cooperation 
cannot be evoked by coercion; it will occur only where no major 
disincentives to meaningful worker participation exist. Without such 
participation, it would be much more difficult, if not impossible, to 
adequately monitor workers' health and to identify workers who need 
temporary or permanent medical removal.

[[Page 68894]]

    MRP is a logical result of medical surveillance. Without MRP, 
responsible employers would be free to maintain high-risk workers in 
their current jobs, which would not be sufficiently protective of their 
health. Alternatively, responsible employers could choose to terminate 
workers or transfer them from higher-paying, beryllium-exposed jobs to 
lower-paying, non-beryllium jobs. This might be protective, but it 
would impair the workers' standards of living. In either case, the 
effectiveness and integrity of the medical surveillance program would 
be compromised.
    With MRP, beryllium-associated workers are assured of being removed 
to jobs where exposure to beryllium is low if such removal is 
determined to be necessary to protect their health. With MRPB, workers 
are assured that, if they fully participate in medical surveillance and 
if the results of medical surveillance require removal from their 
beryllium exposed jobs, their normal earnings and job status will be 
protected for a pre-determined period.
    Thirty-two commenters (Ex. 12 is a form letter submitted by 16 
beryllium workers) commented on the proposed MRP and MRPB provisions in 
the NOPR. They addressed a wide variety of issues and frequently 
expressed opposing viewpoints. For instance, two commenters (Exs. 16, 
26) stated that the proposed MRP provisions went too far (e.g., two 
years of protection is too long; accepted applicants should not be 
included under the provisions), while others (Exs. 3, 8, 12, 14, 17, 
18, 22, 24, 28, 29, 31) stated that the provisions did not go far 
enough (e.g., two years of protection is not long enough; one follow-up 
examination is not enough; the training costs limits are too 
restrictive; the rule should provide provisions for multiple physician 
reviews). Several commenters (Exs. 20, 22, 31) argued against the 
voluntary nature of the proposed provisions, stating that it would be 
unethical to allow a worker with CBD to continue to be exposed to 
beryllium, and suggesting that workers could be wrongfully pressured 
into staying in beryllium-related jobs. Other commenters (Exs. 29, 30) 
agreed with DOE's proposal to require employee consent, and requested 
that DOE provide additional guidance to help workers make more informed 
decisions regarding their medical removal. DOE has decided, consistent 
with some of the comments, to use the provisions of OSHA's expanded 
health standards as the basis for the MRP and MRPB provisions of the 
final rule. DOE has modeled the MRP and MRPB provisions of this final 
rule upon similar provisions in OSHA's Cadmium, Lead and Benzene 
standards, 29 CFR 1910.27, 1910.1025 and 1910.1028, respectively. DOE's 
rationale for each provision of section 850.35 in the final rule is 
discussed below.
    Section 850.35(a) requires responsible employers to offer a 
beryllium-associated worker medical removal from exposure to beryllium 
on each occasion that the SOMD determines in a written medical opinion 
that medical removal is required. The SOMD's determination must be 
based upon one or more positive Be-LPT results, CBD diagnosis, an 
examining physician's recommendation, or any other signs or symptoms 
the SOMD deems medically sufficient to show that the worker has a 
medical condition that places the worker at increased risk of material 
impairment to health from further exposure to beryllium.
    Section 850.35(a)(1) deals with temporary removal. It requires the 
responsible employer to offer temporary medical removal to a beryllium-
associated worker whenever the SOMD determines in a written medical 
opinion that the worker should be removed pending a final medical 
determination on the worker's health. The responsible employer must 
offer to temporarily remove a worker regardless of whether a job is 
available into which the removed worker may be transferred. If no such 
job is available, the responsible employer must pay medical removal 
protection benefits to the worker for up to one year. Section 
850.35(a)(1) (iii) and (iv) require that for each time a beryllium-
associated worker is temporarily removed, the responsible employer must 
maintain the worker's total normal earnings, seniority and other 
employment rights as if the worker were not removed, either by 
providing an appropriate alternative job or by paying MRPB, for one 
year.
    If a final medical determination is made that the worker does not 
have a medical condition which places the worker at increased risk of 
material impairment to health from exposure to beryllium, the temporary 
MRP must be lifted so that the affected worker may return to his or her 
normal duties.
    Section 850.35(a)(2) requires the responsible employer to offer 
beryllium-associated workers permanent medical removal whenever the 
SOMD determines in a written medical opinion that the beryllium-
associated worker should be permanently removed from exposure to 
beryllium. Once a worker is permanently removed, the worker will 
receive the medical removal protection benefits specified in section 
850.35(b) of this rule.
    Section 850.35(a)(3) is intended to ensure that beryllium-
associated workers are given the information needed to make an informed 
decision on whether to accept temporary or permanent removal from a job 
with a potential for beryllium exposure.
    Section 850.35(a)(4)(i) prohibits the responsible employer from 
returning a beryllium-associated worker who has been permanently 
removed to the worker's former job status, unless the SOMD has 
determined in a written medical opinion that removal is no longer 
necessary to protect the worker's health, or the exception in section 
850.35(a)(4)(ii) applies. Under section 850.35(a)(4)(ii), if there are 
special circumstances that make medical removal an inappropriate 
remedy, or if the SOMD's professional opinion is that continued 
exposure will not pose an increased risk to the worker's health (e.g., 
the potential decrements to the worker's lung function are not 
projected to be any greater if the worker were permitted to continue on 
the job than they would be if the worker were removed), the SOMD must 
fully discuss the matter with the worker and, in a written medical 
determination, may recommend returning the worker to his or her former 
job status. The purpose of this exception is to provide some 
flexibility where it is reasonably clear that returning the worker to 
his or her normal job is unlikely to adversely affect the worker's 
health. For example, a return to work may be justified if a worker who 
is not experiencing a decrease in lung function, has been on medical 
removal for 2 years and is about to retire, and the time that the 
worker will continue to be occupationally exposed at or above the 
action level is very limited. If the SOMD recommends return of the 
worker in such cases, the SOMD may require the responsible employer to 
provide the worker with additional protection, such as a supplied air 
respirator operated in a positive pressure mode. In any event, a 
decision to return the worker should be made only after the SOMD has 
fully explained the relevant facts and prognoses to the worker.
    Section 850.35(b) establishes the MRPB that must be provided to 
removed workers. DOE believes that the establishment of MRPB is 
critical to minimize the disability associated with CBD. Removal from 
exposure and effective job-placement efforts, coupled with early 
diagnosis and treatment, will increase the likelihood that affected 
beryllium-associated workers will continue as productive members of the 
DOE workforce. In addition, MRPB will encourage worker participation in 
the

[[Page 68895]]

medical surveillance program by providing beryllium-associated workers 
with a reasonable level of assurance that a finding of sensitization or 
diagnosis of CBD will not lead to the loss of their employment.
    Under section 850.35(b)(1), the responsible employer is required to 
provide up to two years of MRPB to a beryllium-associated worker on 
each occasion that he or she is medically removed from exposure to 
beryllium in accordance with this part.
    Section 850.35(b)(2) requires the responsible employer to provide 
the ``total normal earnings, seniority, and all other workers rights 
and benefits'' of a removed beryllium-associated worker as if the 
worker had not been removed. The purpose of this requirement is to 
ensure that a removed worker does not suffer economic loss due to the 
removal. Thus, if a removed worker routinely earned overtime pay on the 
job from which he or she was removed and would have continued to do so 
during the removal period, then MRPB must include the amount of 
expected overtime as part of the worker's ``total normal earnings.'' 
DOE selected 2 years as the maximum period during which the responsible 
employer is required to pay MRBP to a worker who accepts removal 
instead of the 18 month protection period established in OSHA's Lead 
and Cadmium standards. DOE has established a different protection 
period for beryllium because of the toxicological differences between 
beryllium and the two metals covered in the OSHA standards. 
Specifically, the early stages of the health impairments associated 
with exposure to lead or cadmium will reverse in time with no 
additional exposure, but beryllium sensitization and CBD will not. The 
objective of OSHA's 18 month period is to provide workers with 
sufficient recovery time so that they can return to their job. The 
objective of DOE's 24 month period, however, is to allow beryllium-
associated workers who accept permanent medical removal sufficient time 
to be retrained and placed in different job. DOE believes that this 
period should be long enough to enable the majority of removed 
beryllium-associated workers to be retrained and placed in another job 
or, for those workers who can be returned to their former job status, 
to be returned before their MRPB expire.
    Under section 850.35(b)(3), if a removed worker files a claim for 
workers' compensation payments for a beryllium-related disability, the 
responsible employer must provide MRPB pending disposition of the 
claim. The responsible employer receives no credit for the workers' 
compensation payments received by the worker for treatment related 
expenses.
    In section 850.35(b)(4), the responsible employer's obligation to 
provide MRPB is reduced by the amount of any compensation the 
beryllium-associated worker receives from any other source for earnings 
lost during the period of removal. This provision is necessary to 
ensure that MRPB does not result in a ``windfall'' to the worker who 
collects other compensation, including salary from another job, while 
the worker is on medical removal from exposure to beryllium.
    Section 850.35(b)(5) provides that the requirement that a 
responsible employer provide MRPB is not intended to expand upon or 
restrict any rights a worker has or would have had, absent medical 
removal, to a specific job classification or position under the terms 
of a collective bargaining agreement.
    Section 850.35(b)(6) provides that a responsible employer may 
condition the provision of MRPB upon the beryllium-associated worker's 
participation in medical surveillance. Thus, although the rule does not 
require worker participation in medical surveillance, it permits the 
responsible employer to deny economic protection to workers who are 
unwilling to participate in medical surveillance. Since the responsible 
employer must bear the financial burden of medical removal, the 
employer has a legitimate interest in minimizing the need for medical 
removal. Unless workers participate in medical surveillance, the 
responsible employer may not be able to identify workers whose exposure 
to beryllium should be reduced to avoid the need for medical removal.
    In providing the responsible employer the authority to condition 
provision of MPRB upon a beryllium-associated worker's participation in 
medical surveillance, DOE does not intend to permit an employer to deny 
MRPB for insignificant lapses in such participation. The worker's 
actions should be assessed reasonably, in light of the goal of 
prevention of disease and the employer's interest in minimizing the 
need for medical removal.
Section 850.36--Medical Consent
    Section 850.36 (proposed as section 850.35) establishes the medical 
consent provisions of the CBDPP. Because worker participation in the 
medical surveillance program established by this rule is voluntary, 
this section is necessary to ensure that beryllium-associated workers 
receive adequate information to make an informed decision regarding 
their participation in the program.
    Section 850.36(a) requires responsible employers to provide 
beryllium-associated workers with a summary of the medical surveillance 
program, the type and purpose of data to be collected, how the data 
will be maintained, and protections for ensuring the confidentiality of 
medical records. Responsible employers must provide this information at 
least one week before any medical evaluation or tests, or when 
requested by the worker.
    Section 850.36(b) requires responsible employers to provide 
beryllium-associated workers with information on the benefits and risks 
of the medical tests and examinations offered as part of medical 
surveillance. This information must be provided at least one week prior 
to any examination or test. DOE expects responsible employers to make 
reasonable efforts to help workers understand the material. 
Accordingly, section 850.36(b) requires responsible employers to give 
beryllium-associated workers an opportunity to ask questions and 
receive answers before a medical evaluation is performed.
    Section 850.36(c) requires responsible employers to have the SOMD 
obtain the beryllium-associated worker's signature on the informed 
consent form found in Appendix A to this part, before medical 
evaluations or tests are performed.
Section 850.37--Training and Counseling
    Section 850.37 (proposed as section 850.36) establishes 
requirements for training and counseling workers regarding exposure to 
beryllium, and the potential health effects associated with such 
exposure. This worker training is necessary because the appropriate 
implementation of the required workplace procedures of the CBDPP 
ultimately rests upon the front-line workers who will be performing 
work on, with, or near beryllium or beryllium-contaminated materials. 
These workers cannot be expected to implement the required CBDPP 
procedures if they are not aware or fully appreciative of the 
significance of these procedures.
    DOE expects that responsible employers will conduct training in a 
manner that is easy to understand. Training material should be 
appropriate in content and vocabulary to the education level, and 
language background of affected workers. The goal of training is to 
ensure that all workers, regardless of cultural or educational 
background, have the knowledge necessary to reduce and minimize their 
exposure to beryllium.

[[Page 68896]]

    Section 850.37(a)(1) requires responsible employers to develop and 
implement a worker training program for beryllium-associated workers 
and all other individuals who work at a site where beryllium activities 
are conducted, and ensure their participation in the program. DOE 
recognizes that OSHA's Hazard Communication standard (29 CFR 1910.1200) 
already requires that employers provide their workers with training 
regarding the risks associated with all hazardous materials in the 
workplace. DOE does not intend that employers would implement separate 
and redundant training and information programs to comply with both 
this rule and the Hazard Communication standard. Accordingly, sections 
850.37(b)(1) and (2) require responsible employers' CBDPP training and 
information programs to comply with the Hazard Communication standard 
as well as address the contents of the CBDPP. Through this provision, 
DOE intends for responsible employers to integrate their CBDPP training 
and information efforts into their existing Hazard Communication 
training program. This will minimize the burden on responsible 
employers and provide for a consistent approach to worker training and 
the communication of workplace hazards.
    DOE added ``contents of the CBDPP'' to the training requirements in 
section 850.37(b) because this information is essential for a worker to 
understand how to effectively participate in the CBDPP. OSHA's Hazard 
Communication standard (29 CFR 1910.1200) does not explicitly refer to 
anything like a CBDPP. In the final rule, DOE has removed specific 
mention of several subjects (beryllium health risk, exposure reduction, 
and safe handling of beryllium and medical surveillance) that were 
specifically identified in the proposed rule. These subjects are 
adequately covered in the Hazard Communication standard.
    One commenter (Ex. 3) recommended detailed training for workers who 
have had, or are likely to have, exposures to beryllium because their 
assigned tasks may have involved beryllium. DOE generally agrees with 
the commenter and in the final rule has used a performance-based 
approach to identifying the workers to be trained. Section 850.37(b), 
paragraphs (1) and (2), require detailed training for beryllium-
associated workers.
    In the NOPR (Section V, Request for Information), DOE stated that 
it was considering including a requirement that responsible employers 
develop and implement an outreach education program for family members 
of beryllium workers. Commenters generally agreed on the need to inform 
workers' families about beryllium hazards, but had different views 
about how it should be accomplished. Two commenters (Exs. 16, 26) 
recommended that an outreach requirement not be included in the rule 
and, instead, that workers be relied upon to relay beryllium 
information to their families. Several other commenters (Exs. 17, 28, 
30, 31) recommended that DOE include an outreach requirement in the 
rule, and require employers to provide beryllium information without 
relying on the workers. After considering all of the comments, DOE has 
added section 850.37(b)(3), which requires the responsible employer to 
provide to its workers information about risks to family members. This 
section relies upon the workers to relay the relevant beryllium hazard 
information to their families. DOE encourages responsible employers to 
provide beryllium-associated workers with information about beryllium 
risks that is readily understandable to family members and others, as 
well as to the workers.
    One commenter (Ex. 4) recommended that the requirement for outreach 
not be included as part of the rule, but that DOE provide outreach 
information from a central point in DOE. The commenter felt that this 
approach would be more efficient than having each responsible employer 
develop and provide its own outreach information. DOE disagrees with 
this comment, and is of the view that more effective outreach will be 
provided if responsible employers include information about beryllium 
risks to families and others as part of the detailed training provided 
to beryllium-associated workers and those who use protective clothing 
and equipment.
    One commenter (Ex. 3) recommended general awareness training for 
workers who are not beryllium-associated workers but who, at some time, 
may be at risk because they work at a site where beryllium activities 
are conducted. DOE agrees with this recommendation, and section 
850.37(c) requires the responsible employer to provide general 
awareness training about beryllium hazards and controls to these 
workers.
    Section 850.37(d) requires that the responsible employer provide 
training to workers prior to initial assignment and at least every two 
years thereafter to ensure that workers are appropriately prepared to 
deal with the hazards and risks of working with beryllium. The initial 
training requirement of this paragraph is important to ensure that 
workers have the information they need to protect themselves before 
they are actually subject to exposure or potential exposure hazards. 
Periodic training is necessary to reinforce and update initial 
training, especially with regard to the protective actions workers must 
take at their current jobs to reduce their potential for exposure to 
beryllium. DOE has established the frequency of two years as a minimum 
requirement, rather than the proposed one year.
    Section 850.37(e) requires the responsible employer to provide 
additional training when the employer has reason to believe that a 
beryllium worker lacks the proficiency, knowledge, or understanding 
needed to work safely with beryllium. This situation could occur 
because of changes in workplace operations, controls, or procedures or 
the availability of new or updated information regarding the health 
risk associated with exposures to beryllium. Also, a worker's 
performance may show that the worker has not retained the requisite 
proficiency. DOE used the retraining requirements of the OSHA scaffold 
standard (29 CFR 1926.454(c)) as a model for section 850.37(e).
    Section 850.37(f) requires the responsible employer to develop and 
implement a worker counseling program to assist beryllium-sensitized 
workers and workers diagnosed with CBD. The purpose of the counseling 
program is to communicate to workers information that may help them 
make important health-and work-related decisions and perform 
administrative activities, such as filing workers' compensation claims. 
This section also requires the responsible employer to communicate 
information concerning the following topics: the medical surveillance 
program; medical treatment options; medical, psychological, and career 
counseling; medical benefits; administrative procedures and worker 
rights under applicable workers' compensation laws and regulations; 
work practices aimed at limiting worker exposure to beryllium; and the 
risk of continued exposure after sensitization.
    One commenter (Ex. 23) cautioned that the proposed language dealing 
with workers' compensation counseling could have been interpreted as 
imposing obligations that exceed employer obligations under states' 
workers' compensation statutes. DOE has included in section 850.37(f) 
the qualifying language ``administrative procedures and worker rights'' 
and ``under applicable workers' compensation laws and regulations'' to 
make clear that DOE does not intend to establish any new workers' 
compensation obligations. DOE understands that responsible employers

[[Page 68897]]

may develop such counseling programs in consultation with labor 
organizations representing covered workers, and that employers may wish 
to advise the workers to consult their own attorneys on these matters.
    Another commenter (Ex. 22) recommended that beryllium training be 
provided by organizations or persons who receive grants from DOE. This 
commenter asserted that it is inappropriate for DOE contractors, who 
are responsible employers, to conduct beryllium training because these 
employers are not sufficiently independent. DOE does not agree with 
this comment and has not adopted this recommendation. The vast majority 
of DOE's safety and health training is currently being conducted 
adequately by responsible employers, and it is common outside of DOE 
for employers to provide safety and health training to their employees.
    One commenter (Ex. 21) recommended that this section be revised to 
include the adult education principles outlined in Appendix E of OSHA's 
Hazard Communication standard (29 CFR 1910.1200) because these 
principles have been effective when applied to training workers. While 
DOE has not explicitly referenced this advisory Appendix in the final 
rule, nothing in the rule prohibits its use. Although the Appendix 
appears to be a good example of the use of adult educational principles 
that an employer could use to train workers on their hazard 
communication program, it does not expressly identify or describe these 
principles. Responsible employers would have to infer the principles 
from Appendix E and then apply those principles to their beryllium 
training program. In addition, DOE believes that an explicit reference 
to this Appendix in the rule would be confusing because this Appendix 
is not specifically applicable to beryllium training.
Section 850.38--Warning Signs and Labels
    Section 850.38 (proposed as section 850.37) requires responsible 
employers to post warning signs and labels to ensure that the presence 
and dangers associated with beryllium and beryllium-contaminated 
materials or areas are communicated to workers. Section 850.38(a) 
requires the posting of warning signs at all entranceways to 
established regulated areas and that these signs bear the following 
warning:

DANGER
BERYLLIUM CAN CAUSE LUNG DAMAGE
CANCER HAZARD
AUTHORIZED PERSONNEL ONLY
    The purpose of these signs is to minimize the number of persons in 
a regulated area by warning workers prior to entry. The signs alert 
workers to the fact that they must have the appropriate authorization 
from their supervisor to enter the regulated area. This is especially 
important when regulated areas are established on a temporary basis, 
such as during cleanup operations. In such cases, workers who typically 
work in or travel through the area may not be aware of the new 
potential for exposures to beryllium and, thus, may not be 
appropriately equipped for or aware of the need to protect themselves 
from potential exposures. Warning signs also serve as a constant 
reminder to those who work in regulated areas that the potential for 
exposure to beryllium exists in the area and that appropriate controls 
must be used.
    Sections 850.38(b)(1) requires responsible employers to label with 
appropriate hazard warnings all containers of beryllium, beryllium 
compounds, or beryllium-contaminated clothing, equipment, waste, scrap, 
or debris to ensure that individuals who come in contact with the 
containers are aware of their contents and the need to implement 
special handling precautions. Because the effectiveness of the warning 
labels in achieving these objectives is greatly dependent upon the 
visibility, accuracy, and understandability of the content of the 
labels, section 850.38(b)(2) further specifies that labels bear the 
following information:

DANGER
CONTAMINATED WITH BERYLLIUM
DO NOT REMOVE DUST BY BLOWING OR SHAKING
CANCER AND LUNG DISEASE HAZARD
    Section 850.38(c) clarifies that the warning signs and labels 
developed to comply with the CBDPP must also comply with the OSHA 
Hazard Communication standard, 29 CFR 1910.1200. DOE believes this 
clarification is needed to avoid duplication of effort. In addition, 
DOE believes that ensuring that the content and format of warning signs 
and labels comply with the Hazard Communication standard will result in 
a consistent, recognizable, and comprehensive approach to alerting 
workers to beryllium's potential to cause disease.
    One commenter (Ex. 20) asked if DOE had given consideration to 
requiring that warning signs and labels be provided in languages other 
than English or the use of universal symbols to communicate 
information. DOE notes that 29 CFR 1910.1200(f)(9) (OSHA's Hazard 
Communication standard) states that employers with employees who speak 
other languages may present the information in those other languages, 
as long as the information is presented in English as well. DOE agrees 
with this approach. Thus, section 850.38(c) requires that all warning 
signs and labels comply with 29 CFR 1910.1200.
    Another commenter (Ex. 23) noted that the warning signs provisions 
specified in the NOPR differed slightly from those in DOE Notice 440.1, 
and suggested that DOE retain the NOPR language in the final rule in 
lieu of the language in the Interim CBDPP. DOE notes that the warning 
signs and labels provisions of the NOPR were based on the provisions of 
the Interim CBDPP, with minor modifications added to clarify the intent 
of the requirements. DOE has retained these clarifications in section 
850.38 of the final rule.
    A third commenter (Ex. 9) was concerned that references to cancer 
and cancer hazards in warning signs and labels may be misleading and 
deceptive, and, noting that the reference did not represent the opinion 
of a qualified medical professional, recommended that DOE obtain a 
``qualified medical opinion'' to resolve this issue. DOE believes that 
the action of the International Agency for Research on Cancer (IARC) 
and ACGIH in classifying beryllium as a human carcinogen provides 
sufficient basis for retaining the cancer warning on warning signs and 
labels for beryllium-contaminated materials. DOE further notes that 
NIOSH has classified beryllium as a potential occupational carcinogen 
since 1977.
Section 850.39--Recordkeeping and Use of Information
    Section 850.39 (proposed as section 850.38) requires responsible 
employers to establish and effectively manage records that relate to 
the CBDPP and to periodically submit to the Office of Environment, 
Safety and Health a registry of beryllium-associated workers.
    Section 850.39(a) requires the responsible employer to establish 
and maintain up-to-date and accurate records of all beryllium inventory 
information, hazard assessments, exposure measurements, exposure 
controls, and medical surveillance data. DOE believes that up-to-date 
and accurate records are essential for effectively implementing the 
CBDPP, assessing its adequacy, and studying the relationship between 
workplace conditions and CBD. Some of these records will be needed to 
implement the

[[Page 68898]]

performance feedback provisions in section 850.40.
    One commenter (Ex. 31) recommended that the final rule explicitly 
reference OSHA's regulations at 29 CFR 1910.1200 and CFR 1910.1020. 
OSHA regulations at 29 CFR 1910.1200 (Hazard Communication) already 
require employers to keep records of beryllium inventory information, 
and regulations at 29 CFR 1910.20 (Access to Employee Exposure and 
Medical Records) already require employers to keep records of beryllium 
hazard assessments, exposure measurements, and medical surveillance 
data. DOE has not, however, included in section 850.39 references to 
these OSHA standards. DOE believes that this rule's requirements for 
maintaining and transferring CBDPP-related records, while ensuring 
confidentiality of personal information, are stated in clear and 
concise wording specifically related to the CBDPP that is preferable to 
cross-referenced OSHA standards. Furthermore, one commenter's (Ex. 31) 
primary concern was ensuring that workers have access to the 
information that relates to their personal exposure and medical status. 
DOE has addressed this concern in section 850.24(g), by requiring 
responsible employers to notify affected workers of beryllium 
monitoring results, and in section 850.34(d)(2), by requiring the SOMD 
to provide to workers the results of medical tests and procedures.
    DOE encourages responsible employers to take advantage of existing 
recordkeeping systems to minimize the burden of implementing section 
850.39. Responsible employers also may find that records that are 
generated outside the CBDPP may be useful in implementing the CBDPP. 
Examples are records of beryllium training, personnel demographics, 
beryllium mission descriptions, and payroll records of projects that 
can be used to link workers with potential beryllium exposure.
    Section 850.39(b) requires Heads of DOE Departmental Elements to 
designate all record series required to be generated under this rule as 
federal records and, therefore, subject to all applicable federal 
records management and access laws.
    One commenter (Ex. 18), in commenting on the baseline inventory 
provisions of the proposed rule, recommended that DOE require full 
public disclosure of health and safety documents related to past 
beryllium emissions and exposures. In the final rule, DOE is requiring 
Heads of DOE Departmental Elements to designate the CBDPP-required 
records as federal records. Federal records, except for records 
containing specific types of sensitive information, are available to 
the public under the Freedom of Information Act (FOIA) and related 
federal policy. The FOIA requires the federal government to release 
government records upon request, except for information that is 
exempted from disclosure to protect an overriding interest, such as 
privacy, national security, and trade secrets and other confidential 
business information. The FOIA exemption for information in personnel 
and medical files (5 U.S.C. 552(b)(6)) is especially important for DOE 
CBDPP-required records, because many of these records contain medical 
information that is protected from release by this FOIA provision and 
other federal laws.
    One commenter (Ex. 21) recommended that DOE address the retention 
of records in this rule. DOE has added to section 850.39(b) the 
requirement that Heads of DOE Departmental Elements ensure that the 
record series generated as required under this rule are retained for at 
least 75 years, which is consistent with DOE's policy on retaining 
medical records. This requirement will ensure that required CBDPP 
records that relate to workplace conditions will be available in the 
future to correlate with the beryllium-associated workers' medical 
records. Heads of DOE Departmental elements will be able to ensure that 
they can comply with section 850.39(b) if the CBDPP-required records 
generated by DOE responsible employer contractors are identified in the 
relevant contracts as DOE-owned documents. Therefore, DOE expects that 
Heads of DOE Departmental elements will direct their DOE contract 
officers to stipulate DOE ownership of these documents in those 
contracts.
    The same commenter recommended that DOE address the transfer of 
records to successive responsible employers. DOE agrees that this 
information should be covered in the rule, and has added section 
850.39(c) to require responsible employers to convey to DOE, or its 
designee, all record series generated under this rule if the 
responsible employer ceases to be involved in the CBDPP (e.g., ceases 
to be a DOE contractor).
    Section 850.39(d) requires that responsible employers create links 
between data sets on workplace conditions and health outcomes to serve 
as a basis for understanding the beryllium health risk. This linkage of 
data will assist DOE and responsible employers in identifying unsafe 
work practices and understanding the relationship between workplace 
conditions and CBD.
    Section 850.39(e) requires the responsible employer to ensure the 
confidentiality of all records containing personal, private information 
that are generated as required by this rule. Protecting the 
confidentiality of these records is required by the Americans with 
Disabilities Act (42 U.S.C. 12112(d)(4)), the Privacy Act (5 U.S.C. 
552a) and other applicable laws. In addition, DOE recognizes that many 
beryllium-associated workers will participate in some of the voluntary 
components of the CBDPP only if they believe that their personal 
information will be kept confidential.
    Section 850.39(e)(1) explicitly requires responsible employers to 
ensure that all records that are transmitted to other parties do not 
contain names, social security numbers or any other variables, or 
combination of variables, that could be used to identify individuals. 
DOE recognizes that responsible employers must take these precautions 
to prevent the violation of confidentiality laws because personal 
information could be obtained from transmitted records, or inferred 
from information other than personal identifiers in the records, unless 
these precautions are taken.
    One commenter (Ex. 4) stated that the rule's confidentiality 
requirements could prevent industrial hygienists from obtaining the 
health outcome information that is necessary to perform the linkage of 
site workplace conditions and health outcomes required by section 
850.39(d). DOE does not intend health outcome information that would 
compromise confidentiality to be provided to industrial hygienists. DOE 
believes that the linkage required by section 850.39(d) could be 
performed after personal identifiers are removed from the health 
outcome information, making it consistent with section 850.39(e)(1).
    Another commenter (Ex. 16) recommended that the final rule require 
the responsible employer to place beryllium medical records in the 
custody of a medical director, as opposed to the proposed requirement 
that medical records be held by the responsible employer. DOE 
recognizes that beryllium medical records may be in the custody of 
physicians involved in CBD studies other than the SOMD. DOE responds to 
this commenter's (Ex. 16) concern in section 850.39(e)(2)(i) by 
requiring responsible employers to ensure that individual medical 
information generated by the CBDPP is either included as part of the 
worker's site medical records and maintained by

[[Page 68899]]

the SOMD, or is maintained by another physician designated by the 
responsible employer.
    Section 850.39(e)(2)(ii) (proposed section 850.38(d)) retains the 
proposed requirement that responsible employers ensure that individual 
medical information generated by the CBDPP is maintained separately 
from other records. A commenter (Ex. 19) recommended that the rule 
require responsible employers to use only one data system, maintained 
by the SOMD, to facilitate the analysis of the data and to increase 
workers' confidence in the confidentiality of SOMD-maintained records. 
DOE retained this requirement, however, because the separation of 
medical and other records is good file management. Further, the 
Americans with Disabilities Act (42 U.S.C. 12112(d)(4)(C)) requires 
such separation for privately-owned medical information. DOE recognizes 
that analysis of the data may be somewhat more difficult with 
separately maintained medical records, but separation of these records 
is required by law. There also are practical reasons to require the 
separation of these records. Personnel officials would require 
authorization from medical directors before accessing personnel records 
that were stored with medical records. At the same time, the medical 
directors would need a system to ensure that no confidential medical 
information was mixed in with the personnel records that personnel 
officials accessed. Employers eliminate these administrative burdens by 
maintaining separate medical and personnel records.
    Section 850.39(f) requires the responsible employer to maintain all 
records required by this part in current and accessible electronic form 
to permit ready retrieval of data in a format that maintains 
confidentiality. This requirement is necessary to facilitate timely, 
efficient, and cost-effective transfer and analysis of CBDPP-related 
data. DOE has added the phrase ``in current and accessible'' to this 
section because DOE's experience indicates that the ability to use 
information held in electronic records is severely hampered if the 
electronic systems are out-of-date or the records are difficult to 
obtain. Similarly, DOE has added the phrase ``that maintains 
confidentiality'' to this section because DOE's experience indicates 
that transferring information while maintaining confidentiality cannot 
practically be accomplished using systems that must be modified, 
converted, or replaced before the transfer can occur.
    A commenter (Ex. 21) recommended that the final rule require 
responsible employer contractors to use the same record retrieval 
identifiers that any predecessor contractor used. This would allow 
current contractors easily to link their data to the predecessor 
contractors' data on the same subject. DOE agrees that successive 
contractor's use of the same record retrieval identifiers would make 
exposure-health outcome and epidemiology studies easier to conduct. 
Therefore, DOE encourages successor contractors to use the same record 
retrieval identifiers as the predecessor contractor. DOE has not, 
however, made this a requirement in the final rule because it would be 
inconsistent with DOE's commitment to a performance-based rule to 
mandate this practice. DOE's goal in developing this rule is to allow 
the responsible employer maximum flexibility by specifying in the final 
rule only those record system characteristics and practices that DOE 
believes are essential for achieving successful CBDPPs.
    Section 850.39(g) requires the responsible employer to transmit all 
records required by this rule, in a format that protects the 
confidentiality of individuals, to the DOE Assistant Secretary for 
Environment, Safety and Health on request. DOE replaced 
``Headquarters'' in the proposed rule with ``Assistant Secretary for 
Environment, Safety and Health'' in the final rule to clarify that 
DOE's Office of Environment, Safety and Health is the DOE organization 
that is responsible for conducting occupational health studies that 
involve DOE workers.
    Section 850.39(h) requires the responsible employer semi-annually 
to transmit to the DOE Office of Epidemiologic Studies, Office of 
Environment, Safety and Health, an electronic registry of beryllium-
associated workers. The transmitted registry must protect 
confidentiality and include (but is not limited to) the following 
information for each worker in the registry: a unique identifier, date 
of birth, gender, site, job history, medical screening test results, 
exposure measurements, and results of referrals for specialized medical 
evaluations. DOE's collection of this information conforms to DOE 
Record System 88, ''Epidemiologic and Other Studies, Surveys, and 
Surveillance,'' established as required by the Privacy Act. The Office 
of Epidemiologic Surveillance is responsible for administrative and 
policy decisions related to the beryllium registry and provides 
technical support to the SOMD.
    The medical records generated by the CBDPP will be kept in 
appropriate agency Privacy Act systems of records, such as DOE-33, 
``Personnel Medical Records,'' and/or DOE-88, and will be afforded the 
protection provided by the Privacy Act. Should the agency receive a 
request for these records, it will use every argument legally and 
reasonably available to it, including the authority granted under the 
FOIA and the Privacy Act and the agency's regulations implementing 
those statutes, to protect the privacy of individuals in the records 
generated by the CBDPP. DOE's policy expressed in 10 CFR 1004.3(e)(ii), 
to maximize public disclosure of records that pertain to concerns about 
the environment, public health or safety, or employee grievances, has 
never been applied to jeopardize the privacy interests of individuals 
in their medical records and will not be applied to jeopardize privacy 
interests in records generated by the CBDPP.
    Section 850.39(h) includes ``exposure measurements'' in the 
registry as recommended by a commenter (Ex. 14). DOE had inadvertently 
omitted exposure measurements in the proposed registry provision. Also, 
section 850.39(h) includes beryllium-associated workers as recommended 
by a commenter (Ex. 28), rather than the narrower category of beryllium 
workers as proposed. DOE accepts this recommended change because it 
recognizes that some DOE workers who currently do not perform tasks 
involving beryllium are nonetheless at risk of contracting CBD (based 
on past potential exposure to beryllium) and must be included to 
complete the registry.
    DOE proposed including beryllium-associated workers' names and 
social security numbers in the data that would be included in the 
beryllium registry. Several commenters (Exs. 16, 23, 28) argued that 
including the names and social security numbers of the beryllium-
associated workers in the registry would compromise their privacy. DOE 
has responded to these commenters' concerns by replacing the proposed 
``names'' and ``social security numbers'' with ``unique identifier.'' 
The term ``unique identifier'' is defined in section 850.3(a) to mean 
the part of a paired set of labels, used in records that contain 
confidential information, that does not identify individuals except by 
using the matching label. Only the SOMD will have the key to match the 
unique identifier to the individual. This approach allows health and 
safety professionals and researchers to access the registry data and 
allows the SOMD to inform individuals of relevant study results, while 
maintaining confidentiality at all times.

[[Page 68900]]

    The beryllium registry will serve as a repository for information 
on beryllium-associated workers. DOE will use the registry to determine 
the exposure profile and disease status of beryllium-associated 
workers, and provide feedback to the responsible employer on the 
effectiveness of the CBDPP. The registry will give DOE the ability to 
combine data from different facilities and perform analyses that are 
impossible to perform with the small amount of data that is available 
from each individual facility. The combined data may help DOE identify 
risk factors for CBD and evaluate the predictive value of medical tests 
such as the Be-LPT. Also, researchers may use the registry to conduct 
further epidemiological studies to better understand the cause and 
development of CBD and better identify those at risk.
    One commenter (Ex. 26) recommended that DOE delete the beryllium 
registry from the final rule because the commenter believes that: (1) 
DOE has not adequately described the research for which it will be 
used, and (2) implementing the registry will be costly. This commenter 
suggested, as an alternative, that DOE retain the beryllium registry, 
but include in the rule the specific research protocol that would be 
used. DOE does not agree with the commenter. DOE is confident that the 
registry as provided in the final rule will support the studies needed 
to better understand the relationship between workplace conditions and 
CBD. This knowledge should provide the basis for improved worker 
protections. DOE also thinks that the expense of the registry is well 
justified by these benefits. DOE also disagrees with the recommended 
alternative of including the research protocols in this rule. 
Stipulating research protocols in regulations that could only be 
changed through notice-and-comment rulemaking could stifle research 
activities.
    One commenter (Ex. 19) expressed the concern that DOE's Office of 
Environment, Safety, and Health use of the beryllium registry could 
overshadow important site-specific studies. DOE believes that studies 
at both the site and national level are important for understanding the 
relationship between workplace conditions and CBD. DOE has included 
section 850.39(d), which requires responsible employers to link data on 
workplace conditions and health outcomes, in part to facilitate the 
site level studies. The beryllium registry established by section 
850.39(h) will be used by the Office of Epidemiologic Surveillance to 
support national level studies.
    Two commenters (Exs. 19, 23) recommended that the rule require that 
a university or a university with input from an oversight board, or 
other suitably qualified organizations design the epidemiological 
analysis of the CBDPP-generated data. Although responsible employers 
and DOE's Office of Environment, Safety and Health may use universities 
or other suitably qualified organizations to design these analyses, DOE 
thinks it would be inappropriate to specify the use of such 
organizations in the rule. This recommendation is not adopted.
Section 850.40--Performance Feedback
    The final rule requirements for performance feedback in section 
850.40 are essentially the same as those proposed. Section 850.40(a) 
requires that responsible employers conduct periodic analysis and 
assessment of monitoring results, hazards identified, medical 
surveillance results, attainment of exposure reduction and minimization 
goals, and occurrence reporting data. DOE believes that the analysis of 
these data is important for the continuous improvement of the program.
    To ensure that all workers have the information needed to safely 
perform their assigned tasks, section 850.40(b) requires that results 
of performance assessments conducted in accordance with this rule be 
provided to line managers, planners, worker protection staff, workers, 
medical staff, and others.

                           List of Commenters
------------------------------------------------------------------------
 Exhibit
   No.                         Company/Organization
------------------------------------------------------------------------
      1   Atomic Weapons Establishment (AWE)
      2   Oak Ridge Institute for Science and Education (ORISE)
      3   U.S. Department of Navy, Navy Environmental Health Center
      4   Fluor Daniel Hanford, Incorporated
      5   Burlin McKinney
      6   Idaho National Engineering and Environmental Laboratory
           (INEEL), Operated by Lockheed Martin
      7   Freddy D. Marler Jr.
      8   Alfred Glenn Bell
      9   Lockheed Martin Idaho Technologies Company, INEEL
     10   A Concerned American Citizen
     11   Robert A. Gadon, CIH
     12   Daniel R. Roberts, Danny Bush, Willie James Brooks, C.E.
           Tilley, Robert Lang Freels, Edna & Ernest Hugart, Victoria L.
           O'Sheel, Kenneth L. Moore, Cheryll A. Dyer, James M. Harvey,
           J. R. Miller, Luis Revilla, Connie Willis, Bruce Lawson, Lynn
           & Linda Cox, Roy & Debra Jones
     13   American Industrial Hygiene Association (AIHA)
     14   Gary Foster
     15   Darrell Lawson
     16   University of California, Laboratory Administration
     17   Hanford Environmental Health Foundation
     18   Serious Texans Against Nuclear Dumping (STAND), Incorporated
     19   American College of Occupational and Environmental Medicine
     20   Occupational Safety and Health Administration (OSHA)
     21   University of Cincinnati Medical Center
     22   Paper, Allied Industrial Chemical & Energy Workers Union
           (PACE)
     23   Kaiser-Hill Company, Rocky Flats Environmental Technology Site
     24   Lockheed Martin Energy Systems, Incorporated, (Y-12 Facility)
     25   Lockheed Martin Energy Research Corporation (Oak Ridge
           Laboratory)
     26   Brush Wellman, Incorporated
     27   James Turner
     28   National Jewish Medical and Research Center
     29   National Institute for Occupational Safety and Health (NIOSH)
     30   Consortium for Risk Evaluation with Stakeholder Participation
           (CRESP)
     31   International Chemical Workers Union Council of the United
           Food and Commercial Workers International Union (ICWUC/UFCW)
     32   Concerned Citizens for Nuclear Safety (CCNS)
     33   Stanford Linear Accelerator Center (SLAC)
     34   Fermi National Accelerator Laboratory (Fermi Lab)
     35   United Steelworkers, Local 8031
     36   U.S. House of Representatives, Van Hilleary
     37   National Institute for Occupational Safety and Health (NIOSH)
     38   Atomic Weapons Establishment (AWE)
     38   Commodore Advance Science, Incorporated
     40   Hanford Environmental Health Foundation
     41   Oak Ridge National Laboratory
     42   Argonne National Laboratory
     43   Fluor Daniel Hanford, Incorporated
     44   University of Cincinnati Medical Center
     45   Gary Foster
     46   Pantex Plant
     47   Kaiser-Hill, Rocky Flats Environmental Technology Site
     48   Paper, Allied Industrial Chemical & Energy Workers Union
           (PACE)
     49   Consortium for Risk Evaluation with Stakeholder Participation
           (CRESP)
     50   Brush Wellman, Incorporated
     51   University of Cincinnati

[[Page 68901]]

 
     52   Building & Construction Trades Department, AFL-CIO
------------------------------------------------------------------------

V. Procedural Requirements

A. Review Under Executive Order 12866

    This rulemaking has been determined to be a significant regulatory 
action under Executive Order 12866, ``Regulatory Planning and Review,'' 
58 FR 51735 (October 4, 1993). Accordingly, today's action was subject 
to review under the executive order by the Office of Information and 
Regulatory Affairs (OIRA). The assessment of the potential costs and 
benefits of the proposed rule, which was made available to the public 
when the NOPR was published in the Federal Register, was updated to 
reflect changes made in the final rule.
    Before conducting the assessment, DOE profiled the sites and 
activities that will be affected by the CBDPP rule and estimated the 
number of workers that will be affected by the rule. DOE estimates that 
1,634 workers may be exposed or potentially exposed to airborne 
concentrations of beryllium in the DOE complex. Furthermore, DOE 
estimates that 1,236 of these workers (75.6 percent) are potentially 
exposed above the action level or the PEL prescribed in the CBDPP rule.
    DOE began the cost estimation by reviewing the rule to determine 
which requirements of the rule will impose costs on affected entities. 
DOE then determined the controls (e.g., implementation of procedures, 
purchase of equipment) necessary for affected entities to be in 
compliance with each requirement. DOE's assessment refers to these 
determinations as compliance profiles. Since the goal of the compliance 
cost estimation is to determine the incremental costs of compliance 
(OMB Guidance, 1996), the compliance profiles were compared to the 
procedures and controls that are currently in place at DOE facilities 
affected by the rule (i.e., the baseline). Procedures and controls 
required by the CBDPP rule that are not currently in place at DOE 
facilities were considered new to the facilities, and thus would impose 
incremental costs on the affected entities. The compliance profiles 
were then adjusted to reflect only the required incremental controls.
    The next step in DOE's assessment was to estimate the costs for 
each compliance profile. DOE collected data on the cost of each element 
contained in the compliance profiles. The profiles are designed to 
reflect the full opportunity cost of compliance. For example, the 
compliance profile for performing a Be-LPT test includes not only the 
test itself, but also the labor time for the worker and physician to 
conduct the test, shipping the sample to a lab, and analyzing and 
interpreting the results of the test. The cost data was obtained from a 
variety of sources, including CBDPP plans submitted under DOE Notice 
440.1, a 1999 Environment, Safety and Health (EH) Cost Survey, contact 
with DOE facilities subject to the CBDPP rule, trade publications, the 
U.S. Office of Personnel Management (OPM) (e.g., for wage rates), and 
previous economic analyses of other regulations (e.g., regulatory 
impact analyses of OSHA health standards). This cost data was then 
applied to the compliance profiles to determine the costs associated 
with each profile, providing an estimate of the incremental cost for 
each requirement.
    DOE-wide cost estimates for each requirement were generated by 
multiplying the number of units affected by each requirement by the 
incremental cost for each requirement. Costs estimated in this step 
were then annualized using a discount rate. Discount rates are used to 
translate costs (and benefits) that are incurred in future years into a 
present value. Following OMB Guidance (1992), DOE chose a 7 percent 
discount rate. In the analysis, DOE uses the 7 percent discount rate 
for three purposes: (1) To annualize the costs of equipment or other 
program elements that have a lifetime of more than one year, (2) to 
translate the costs incurred in future years into a present value, and 
(3) to calculate the annualized cost of initial requirements of DOE N 
440.1 and the CBDPP rule.
    DOE estimated the total compliance costs of the CBDPP, including 
the costs of the interim CBDPP under DOE Notice 440.1 and the costs of 
this final rule. DOE estimates an $8.54 million annualized cost on DOE 
contractors between July 1997 and December 1999 (compliance with DOE 
Notice 440.1) and a $31.55 million annualized cost on DOE contractors 
between December 1999 (the assumed effective date of the final rule) 
and December 2009. This includes an initial (i.e., startup) cost of 
$9.02 million incurred in July 1997 and another initial cost of $2.22 
million incurred in December 1999.
    DOE also assessed the potential benefits of the CBDPP for DOE, DOE 
contractors, and workers. DOE assessed the following benefits of the 
CBDPP rule: (1) Reduced medical costs; (2) reduced mortality; (3) 
increased quality of life; (4) increased medical surveillance for 
workers at risk; (5) increased work-life for beryllium workers; (6) 
increased productivity; (7) reduced legal costs for DOE and DOE 
contractors; and (8) a reduction in the externality associated with 
beryllium exposure through a transfer of the medical costs from workers 
to DOE contractors. Because sufficient information on the dose-response 
relationship for beryllium is not available within the scientific 
community, DOE could not relate reduced levels of exposure to a 
specific reduction in CBD and beryllium sensitization. Nevertheless, 
DOE estimates that the monetary benefits from reduced lifetime medical 
costs could range from $10,100 to $16,093 for each avoided case of 
beryllium sensitization or CBD.
    DOE also assessed the potential economic impacts of the rule on the 
provision of public goods that contain beryllium and the impact on the 
market for beryllium. DOE assessed each of these potential impacts and 
determined neither will impose a significant economic impact. DOE 
determined that the potential reduction in the provision of beryllium-
containing public goods will be minimal and, consequently, the 
reduction in demand for beryllium will also be small.
    DOE's assessment of the potential costs and benefits of the final 
has been placed in the rulemaking file (Docket Number EH-RM-98-BRYLM). 
DOE also has placed in the rulemaking file a document that identifies 
the substantive changes between the draft final rule submitted to the 
OIRA for review and the final rule published today, including 
identification of the changes suggested or recommended by OIRA. These 
documents may be reviewed and copied at the DOE of Information Reading 
Room, Room 1E-190, 1000 Independence Avenue, SW, Washington, DC 20585, 
between the hours of 8:30 a.m. and 4:00 p.m., Monday through Friday, 
except Federal holidays.

B. Review Under the Regulatory Flexibility Act

    The Regulatory Flexibility Act, 5 U.S.C. 601-612, requires that an 
agency prepare a regulatory flexibility analysis and publish it at the 
time of publication of general notice of proposed rulemaking for the 
rule. This requirement does not apply if the agency certifies that the 
rule will not, if promulgated, have a significant economic impact on a 
substantial number of small entities (5 U.S.C. 605(b)).

[[Page 68902]]

    Today's action establishes DOE's regulations for a CBDPP to reduce 
the number of DOE Federal and contractor workers exposed to beryllium, 
minimize the levels of and potential for exposure to beryllium, and 
establish medical surveillance requirements to ensure early detection 
of disease. The contractors who manage and operate DOE facilities are 
principally responsible for implementing the CBDPP. DOE has considered 
whether these contractors are ``small businesses,'' as that term is 
defined by the Regulatory Flexibility Act (5 U.S.C. 601(3)). The 
Regulatory Flexibility Act's definition incorporates the definition of 
``small business concern'' in the Small Business Act, which the Small 
Business Administration (SBA) has developed through size standards in 
13 CFR part 121. Small businesses are business concerns which, together 
with their affiliates, have no more than 500 to 1500 employees, varying 
by SIC category, and annual receipts of between $0.5 million to $25 
million, again varying by SIC category. The DOE contractors subject to 
the CBDPP requirements exceed the SBA's size standards for small 
businesses. In addition, DOE contractors are reimbursed through their 
contracts with DOE for the costs of complying with DOE health and 
safety program requirements. They will not, therefore, be adversely 
impacted by the requirements in the rule. For these reasons, DOE 
certifies that the final rule will not have a significant economic 
impact on a substantial number of small entities.

C. Review Under the Paperwork Reduction Act

    DOE submitted the proposed collections of information in this rule 
to the Office of Management and Budget for review under section 3507(d) 
of the Paperwork Reduction Act of 1995 (42 U.S.C. 3507(d)). The 
information that DOE contractors are required to produce, maintain and 
report is necessary to permit the Department to manage and oversee the 
health and safety programs that control worker exposure to beryllium. 
The Office of Management and Budget has not yet approved the 
collections of information in this rule. An agency may not conduct or 
sponsor, and a person is not required to respond to a collection of 
information unless it displays a currently valid OMB control number (5 
CFR 1320.5(b)).

D. Review Under the National Environmental Policy Act

    DOE has reviewed the promulgation of 10 CFR Part 850 under the 
National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321 et 
seq.), the Council on Environmental Quality regulations for 
implementing NEPA (40 CFR parts 1500-1508), and DOE's NEPA implementing 
procedures (10 CFR Part 1021). DOE has completed an Environmental 
Assessment, and on the basis of that assessment has determined that an 
environmental impact statement is not required and issued a Finding of 
No Significant Impact (FONSI) for this rule. In the Notice of Proposed 
Rulemaking, the Department announced the availability of the draft 
Environmental Assessment and requested comments on the Assessment. DOE 
did not receive any comments on the draft Environmental Assessment. The 
Environmental Assessment updates the draft Environmental Assessment 
(DOE/EA 1249) to reflect changes in the final rule made in response to 
public comments on the rule. The Environmental Assessment and FONSI are 
available for inspection at the DOE Freedom of Information Reading 
Room, 1E-190, 1000 Independence Avenue SW, Washington, DC 20585, 
between the hours of 9 a.m. and 4 p.m., Monday through Friday, except 
Federal holidays.

E. Review Under Executive Order 13132

    Executive Order 13132 (64 FR 43255, August 4, 1999), imposes 
certain requirements on agencies formulating and implementing policies 
or regulations that preempt State law or that have federalism 
implications. Agencies are required to examine the constitutional and 
statutory authority supporting any action that would limit the 
policymaking discretion of the States and carefully assess the 
necessity for such actions. DOE has examined today's rule and has 
determined that it does not preempt State law and does not have a 
substantial direct effect on the States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government. No further 
action is required by Executive Order 13132.

F. Review Under Executive Order 12988

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

G. Review Under the Unfunded Mandates Reform Act of 1995

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

H. Review Under Small Business Regulatory Enforcement Fairness Act of 
1996

    As required by 5 U.S.C. 801, DOE will report to Congress 
promulgation of this rule prior to its effective date. The report will 
state that it has been

[[Page 68903]]

determined that the rule is not a ``major rule'' as defined by 5 U.S.C. 
804(2).

Appendix A to the Preamble References

1. ``Beryllium Disease: Reducing the Risks.'' National Jewish 
Medical and Research Center Website (http://www.nationaljewish.org/
beryllium/). 1999.
2. Green DM et al. ``Agency for Toxic Substances and Disease 
Registry (ASTDR) Case Studies in Environmental Medicine, No.19.'' 
U.S. Department of Health and Human Services. 1992.
3. Hardy HL, Tabershaw IR. ``Delayed Chemical Pneumonitis Occurring 
in Workers Exposed to Beryllium Compounds.'' Journal of Industrial 
Hygiene Toxicology, Volume 28:197 (1946).
4. Powers MB. ``History of Beryllium.'' In Beryllium Biomedical and 
Environmental Aspects. Rossman MD, Preuss OP, and Powers MB, eds. 
Baltimore: Williams and Wilkins, 1991.
5. Eisenbud M et al. ``Non-occupational Berylliosis.'' Journal of 
Industrial Hygiene Toxicology, Volume 31:282-294 (1949).
6. Eisenbud M, Lisson J. ``Epidemiologic Aspects of Beryllium-
Induced Nonmalignant Lung Disease: A 30-Year Update.'' Journal of 
Occupational Medicine, Volume 25:196-202 (1983).
7. Sterner JH, Eisenbud M. ``Epidemiology of Beryllium 
Intoxication.'' Archives of Industrial Hygiene and Occupational 
Medicine, Volume 4:123-157 (1951).
8. Newman LS, Kreiss K. ``Nonoccupational Beryllium Disease 
Masquerading as Sarcoidosis: Identification by Blood Lymphocyte 
Proliferative Response to Beryllium.'' American Review of 
Respiratory Disease, Volume 145:1212-1214 (1992).
9. Tepper LB. ``Introduction.'' In: Beryllium Biomedical and 
Environmental Aspects. Rossman MD, Preuss OP, and Powers MB, eds. 
Baltimore: Williams and Wilkins, 1991.
10. Sprince NL, Kazemi H. ``Beryllium Disease.'' In: Environmental 
and Occupational Medicine, 2nd ed. Room W, ed. Boston: Little, 
Brown, 1992.
11. Newman LS et al. ``Pathologic and Immunologic Alterations in 
Early Stages of Beryllium Disease. Reexamination of Disease 
Definition and Natural History.'' American Review of Respiratory 
Disease, Volume 139:1479-11486, (1989).
12. Kreiss K, Newman LS, Mroz MM, Campbell, PA. ``Screening Blood 
Test Identifies Subclinical Beryllium Disease.'' Journal of 
Occupational Medicine, Volume 31:603-608 (1989).
13. Rossman MD, Kern JA, Elias JA et al. ``Proliferative Response of 
Bronchoalveolar Lymphocytes to Beryllium: A Test For Chronic 
Beryllium Disease.'' Annals of Internal Medicine, Volume 108:687-693 
(1988).
14. Saltini C, Winestock K, Kirby M et al. ``Maintenance of 
Alveolitis in Patients with Chronic Beryllium Disease by Beryllium 
Specific Helper T-Cells.'' New England Journal of Medicine, Volume 
320:103-1109 (1989).
15. Cullen MR et al. ``Chronic Beryllium Disease in a Metal 
Refinery. Clinical Epidemiologic and Immunologic Evidence for 
Continuing Risk from Exposure to Low Level Beryllium Fume.'' 
American Review of Respiratory Disease, Volume 135(1):201-208 
(1987).
16. Kreiss K, Mroz MM, Zhen B et al. ``Epidemiology of Beryllium 
Sensitization and Disease in Nuclear Workers.'' American Review of 
Respiratory Disease, Volume 148:985-991 (1993).
17. Kreiss K et al. ``Beryllium Disease Screening in the Ceramics 
Industry.'' Journal of Occupational Medicine, Volume 35:267-274 
(1993).
18. Health Assessment Document for Beryllium [Publication No. EPA/
600/8-84/026F] U.S. Environmental Protection Agency. (1987).
19. Stange AW et al. ``Possible Health Risks from Low Level Exposure 
to Beryllium.'' Toxicology, Volume 111:213-224 (1996).
20. Barnard AE, et al. ``Retrospective Beryllium Exposure Assessment 
at the Rocky Flats Environmental Technology Site.'' American 
Industrial Hygiene Association Journal, Volume 57:804-808 (1996).
21. Kreiss K et al. ``Machining Risk of Beryllium Disease and 
Sensitization with Median Exposures Below 2 g/m\3\,'' 
American Journal of Industrial Medicine, Volume 30:16-25 (1996).
22. Kreiss K, Mroz M, Zhen B, Wiedemann H, Barna B. Risks of 
beryllium disease related to work processes at a metal, alloy, and 
oxide production plant. Occupational and Environmental Medicine, 
Volume 54:605-612 (1997).
23. Cohen BS. ``Air Sampling.'' In: Beryllium Biomedical and 
Environmental Aspects. Rossman MD, Preuss OP, and Powers MB, eds. 
Baltimore: Williams and Wilkins, 1991.
24. Finch GL. ``In Vitro Dissolution Characteristics of Beryllium 
Oxide and Beryllium Metal Aerosols.'' Journal of Aerosols Science, 
Volume 19:333-342 (1988).
25. Newman LS. ``To Be2+ or Not to Be2+ : 
Immunogenetics and Occupational Exposure.'' Science, Volume 262:197-
198 (8 October 1993).
26. Haley PJ. ``Mechanisms of Granulomatous Lung Disease from 
Inhaled Beryllium: The Role of Antigenicity in Granuloma 
Formation.'' Toxicologic Pathology, Volume 19:514-525 (1991).
27. Finch GL. ``Clearance, Translocation, and Excretion of Beryllium 
Following Inhalation of Beryllium Oxide by Beagle Dogs.'' 
Fundamentals of Applied Toxicology, Volume 15:231-241 (1990).
28. Richeldi L et al. ``HLA-DPB1 Glutamate 69: A Genetic Marker of 
Beryllium Disease.'' Science, Volume 262:242-244 (8 October 1993).
29. Eisenbud M. ``The Standard for Control of Chronic Beryllium 
Disease.'' Applied Occupational Environmental Hygiene, Volume 
13(1):25-31 (January 1998).
30. Pappas GP et al. ``Early Pulmonary Physiologic Abnormalities in 
Beryllium Disease.'' American Review of Respiratory Disease, Volume 
148:661-666 (1993).
31. Yoshida T et. al. ``A Study on the Beryllium Lymphocyte 
Transformation Test and the Beryllium Levels in Working 
Environment.'' Industrial Health, Volume 35(3):374-9 (Jul 1997).
32. Threshold Limit Value for Chemical Substances and Physical 
Agents and Biological Exposure Indices, Notice of Intended Change 
(1999).
33. U.S. Environmental Protection Agency: Integrated Risk 
Information System, Substance File--Beryllium and Compounds, CASRN 
7440-41; U.S. Environmental Protection Agency, Washington, DC 
(1998).
34. Epstein WL. ``Cutaneous Effects of Beryllium.'' In: Beryllium 
Biomedical and Environmental Aspects. Rossman MD, Preuss OP, and 
Powers MB, eds. Baltimore: Williams and Wilkins, 1991.
35. Sanderson WT et. al. ``Beryllium Contamination Inside Vehicles 
of Machine Shop Workers.'' Applied Occupational Environmental 
Hygiene, Volume 14:223-230 (1999).

Appendix B to the Preamble--Questions and Answers Concerning the 
Beryllium-Induced Lymphocyte Proliferation Test (Be-LPT), Medical 
Records, and the Department of Energy (DOE) Beryllium Registry

What Is the Be-LPT Blood Test?

    In the Be-LPTs, disease-fighting blood cells that are normally 
found in the body, called lymphocytes, are examined in the laboratory 
and separated from your blood. Beryllium and other test agents are then 
added to small groups of these lymphocytes. If these lymphocytes react 
to the beryllium in a specific way, the test results are ``positive.'' 
If they do not react to beryllium, the test is ``negative.''
    Experts believe that the Be-LPT shows positive results in 
individuals who have become sensitive or allergic to beryllium. It is 
unclear what this sensitivity means. Studies have shown it to be an 
early sign of chronic beryllium disease (CBD) in many individuals. In 
others, sensitivity might simply mean that the person was exposed to 
beryllium and that his or her body has reacted. It might mean that an 
individual is more likely than others to get CBD. You are being offered 
the Be-LPT because doctors believe it is useful in detecting cases of 
CBD early or cases that might otherwise be missed or diagnosed as 
another type of lung problem. Once CBD is identified, doctors can 
determine the treatment that is needed to minimize the lung damage that 
CBD causes.
    As in any other medical test, the Be-LPT sometimes fails or 
provides unclear results. The laboratory calls these results 
``uninterpretable.'' Even when the test appears successful, it may 
appear positive when a person is not sensitive or allergic to 
beryllium. This is called a ``false positive'' result. It is also

[[Page 68904]]

possible that the test will show ``negative'' results when a person is 
actually ``sensitized'' to beryllium. This is a ``false negative'' 
result. If you have a ``uninterpretable'' blood Be-LPT result, you will 
be asked to provide another blood sample so the test can be repeated. 
If you have ``positive'' results, you will be offered further medical 
tests to confirm or rule out CBD. Remember that you may refuse further 
tests at this point or at any point during your medical evaluations.
    It is important for you to know that if the physical examination or 
the results from other tests you are receiving suggest that you have 
CBD, you may be offered further medical tests. These medical tests may 
be offered even if your Be-LPT is ``negative.''
    Some individuals with confirmed ``positive'' Be-LPTs but no other 
signs of CBD have developed the disease. The likelihood of this 
happening will only be known after large groups of potentially exposed 
individuals have had their blood tested, have had further medical 
tests, and are studied for many years.

Do I Have To Have the Be-LPT Done?

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

What Will Happen if I Decide To Have the Be-LPT Blood Test?

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

When Will I Receive the Results of My Be-LPT Blood Test?

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

Could a Positive Be-LPT Blood Test Affect My Job Assignment?

    Yes. If you have a positive Be-LPT or have been diagnosed with CBD, 
your employer may inform you that the SOMD has recommended that you be 
temporarily or permanently removed from working with beryllium. You 
will be given information and counseling to help you decide whether to 
accept medical removal. If you agree to medical removal, every effort 
will be made to offer you another job that you are qualified (or can be 
trained for in a short period) to perform and where the beryllium 
exposures will be as low as possible, but in no case above the action 
level.
    If you are temporarily removed, you will maintain your total normal 
earnings, seniority, and other benefits until you are placed in another 
job for 1 year, whichever comes first. If you are permanently removed, 
you will maintain your total normal earnings, seniority, and other 
benefits until you are placed in another job or for 2 years, whichever 
comes first. If you become physically unable to continue working, you 
may be eligible for workers' compensation and other benefits.

Will I Lose Any Pay or Any Other Benefits by Having the Examination 
During Normal Working Hours?

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

What Will Happen to the Records of the Medical Examination Results?

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

What Laws Protect Me if I Consent To Participate in the Blood Be-LPT 
Testing Program?

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

Can My Privacy and the Confidentiality of My Medical Records Be 
Guaranteed?

    No. Access to or release of records could be required under court 
order, or DOE directive, but it is unlikely. It would also be available 
as the Freedom of Information Act or Privacy Act provide, such as to 
Congress, to an individual upon a showing of compelling circumstances 
affecting the health and safety of an individual, etc. If you apply for 
another job or for insurance, you may be requested to release the 
records to a future employer or an insurance company. If, for medical 
reasons, it is recommended that you transfer to an area where you will 
not contact beryllium, and you elect to do so, the personnel department 
and your supervisor will be notified. They will not be told the 
specific results of your tests but, because of the restrictions, they 
may assume that your Be-LPT results were positive.

[[Page 68905]]

What Is the DOE Beryllium Registry?

    Your health and the health of all workers is a major concern to 
DOE. There is a need to learn more about chronic beryllium disease and 
what causes some individuals to react more strongly than others do. A 
DOE beryllium registry has been established to collect and maintain 
information on workers who are exposed to beryllium. This registry is a 
tool that will be used in health studies to better understand the 
nature of the disease. With it we can measure the burden of health 
effects related to beryllium exposure. The registry will also be used 
to evaluate the effectiveness of exposure control programs.
    In addition to information about your beryllium-related exposures, 
the results of beryllium sensitization testing and/or CBD status 
collected by your employer will be added to the registry. Your employer 
must treat this information as confidential medical information and can 
only use or disclose this information in conformance with the Privacy 
Act of 1974, the Americans with Disabilities Act, and other applicable 
laws. Your employer will establish a unique identifier for you that 
will be included in the registry instead of your personal identifying 
information (such as your name and social security number). The unique 
identifier will be used to inform your employer of any study results 
that you and your employer's Site Occupational Medical Director (SOMD) 
should know about. The SOMD will know to whom the unique identifier 
refers and will notify you of these results. At no time will your name 
or other personal identifying information be included in any report. 
The confidentiality of personal information in DOE records is protected 
under the Privacy Act of 1974.

List of Subjects in 10 CFR Part 850

    Beryllium, Chronic beryllium disease, Hazardous substances, Lung 
diseases, Occupational safety and health, Reporting and recordkeeping 
requirements.

    Issued in Washington, D.C., on November 24, 1999.
Bill Richardson,
Secretary of Energy.
    For the reason set forth in the preamble, Title 10, Chapter III of 
the Code of Federal Regulations is amended by adding a new part 850 as 
set forth below.

PART 850--CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM

Subpart A--General Provisions

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

Subpart B--Administrative Requirements

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

Subpart C--Specific Program Requirements

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

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

    Authority: 42 U.S.C. 2201(i)(3), (p); 29 U.S.C. 668; E.O. 12196, 
3 CFR 1981 comp., p. 145 as amended.

Subpart A--General Provisions


Sec. 850.1  Scope.

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


Sec. 850.2  Applicability.

    (a) This part applies to:
    (1) DOE offices responsible for operations or activities that 
involve present or past exposure, or the potential for exposure, to 
beryllium at DOE facilities;
    (2) DOE contractors with operations or activities that involve 
present or past exposure, or the potential for exposure, to beryllium 
at DOE facilities; and
    (3) Any current DOE employee, DOE contractor employee, or other 
worker at a DOE facility who is or was exposed or potentially exposed 
to beryllium at a DOE facility.
    (b) This part does not apply to:
    (1) Beryllium articles; and
    (2) DOE laboratory operations that meet the definition of 
laboratory use of hazardous chemicals in 29 CFR 1910.1450, Occupational 
Exposure to Hazardous Chemical in Laboratories.


Sec. 850.3  Definitions.

    (a) As used in this part:
    Action level means the level of airborne concentration of beryllium 
established pursuant to section 850.23 of this part that, if met or 
exceeded, requires the implementation of worker protection provisions 
specified in that section.
    Authorized person means any person required by work duties to be in 
a regulated area.
    Beryllium means elemental beryllium and any insoluble beryllium 
compound or alloy containing 0.1 percent beryllium or greater that may 
be released as an airborne particulate.
    Beryllium activity means an activity taken for, or by, DOE at a DOE 
facility that can expose workers to airborne beryllium, including but 
not limited to design, construction, operation, maintenance, or 
decommissioning, and which may involve one DOE facility or operation or 
a combination of facilities and operations.
    Beryllium article means a manufactured item that is formed to a 
specific shape or design during manufacture, that has end-use functions 
that depend in whole or in part on its shape or design during end use, 
and that does not release beryllium or otherwise result in exposure to 
airborne concentrations of beryllium under normal conditions of use.
    Beryllium-associated worker means a current worker who is or was 
exposed or potentially exposed to airborne concentrations of beryllium 
at a DOE facility, including:
    (1) A beryllium worker;
    (2) A current worker whose work history shows that the worker may 
have been exposed to airborne concentrations of beryllium at a DOE 
facility;
    (3) A current worker who exhibits signs or symptoms of beryllium 
exposure; and
    (4) A current worker who is receiving medical removal protection 
benefits.
    Beryllium emergency means any occurrence such as, but not limited 
to, equipment failure, container rupture, or failure of control 
equipment or operations that results in an unexpected

[[Page 68906]]

and significant release of beryllium at a DOE facility.
    Beryllium-induced lymphocyte proliferation test (Be-LPT) is an in 
vitro measure of the beryllium antigen-specific, cell-mediated immune 
response.
    Beryllium worker means a current worker who is regularly employed 
in a DOE beryllium activity.
    Breathing zone is defined as a hemisphere forward of the shoulders, 
centered on the mouth and nose, with a radius of 6 to 9 inches.
    DOE means the U.S. Department of Energy.
    DOE contractor means any entity under contract with DOE (or its 
subcontractor) that has responsibility for performing beryllium 
activities at DOE facilities.
    DOE facility means any facility operated by or for DOE.
    Head of DOE Field Element means an individual who is the manager or 
head of the DOE operations office or field office, or any official to 
whom the Head of DOE Field Element delegates his or her functions under 
this part.
    High-efficiency particulate air (HEPA) filter means a filter 
capable of trapping and retaining at least 99.97 percent of 0.3 
micrometer monodispersed particles.
    Immune response refers to the series of cellular events by which 
the immune system reacts to challenge by an antigen.
    Medical removal protection benefits means the employment rights 
established by section 850.35 of this part for beryllium-associated 
workers who voluntarily accept temporary or permanent medical removal 
from beryllium areas following a recommendation by the Site 
Occupational Medicine Director.
    Operational area means an area where workers are routinely in the 
presence of beryllium as part of their work activity.
    Regulated area means an area demarcated by the responsible employer 
in which the airborne concentration of beryllium exceeds, or can 
reasonably be expected to exceed, the action level.
    Removable contamination means beryllium contamination that can be 
removed from surfaces by nondestructive means, such as casual contact, 
wiping, brushing or washing.
    Responsible employer means:
    (1) For DOE contractor employees, the DOE contractor office that is 
directly responsible for the safety and health of DOE contractor 
employees while performing a beryllium activity or other activity at a 
DOE facility; or
    (2) For DOE employees, the DOE office that is directly responsible 
for the safety and health of DOE Federal employees while performing a 
beryllium activity or other activity at a DOE facility; and
    (3) Any person acting directly or indirectly for such office with 
respect to terms and conditions of employment of beryllium-associated 
workers.
    Site Occupational Medical Director (SOMD) means the physician 
responsible for the overall direction and operation of the site 
occupational medicine program.
    Unique identifier means the part of a paired set of labels, used in 
records that contain confidential information, that does not identify 
individuals except by using the matching label.
    Worker means a person who performs work for or on behalf of DOE, 
including a DOE employee, an independent contractor, a DOE contractor 
or subcontractor employee, or any other person who performs work at a 
DOE facility.
    Worker exposure means the exposure of a worker to airborne 
beryllium that would occur if the worker were not using respiratory 
protective equipment.
    (b) Terms undefined in this part that are defined in the Atomic 
Energy Act of 1954 shall have the same meaning as under that Act.


Sec. 850.4  Enforcement.

    DOE may take appropriate steps under its contracts with DOE 
contractors to ensure compliance with this part. These steps include, 
but are not limited to, contract termination or reduction in fee.


Sec. 850.5  Dispute resolution.

    (a) Subject to paragraphs (b) and (c) of this section, any worker 
who is adversely affected by an action taken, or failure to act, under 
this part may petition the Office of Hearings and Appeals for relief in 
accordance with 10 CFR part 1003, Subpart G.
    (b) The Office of Hearings and Appeals may not accept a petition 
from a worker unless the worker requested the responsible employer to 
correct the violation, and the responsible employer refused or failed 
to take corrective action within a reasonable time.
    (c) If the dispute relates to a term or condition of employment 
that is covered by a grievance-arbitration provision in a collective 
bargaining agreement, the worker must exhaust all applicable grievance-
arbitration procedures before filing a petition for relief with the 
Office of Hearings and Appeals. A worker is deemed to have exhausted 
all applicable grievance-arbitration procedures if 150 days have passed 
since the filing of a grievance and a final decision on it has not been 
issued.

Subpart B--Administrative Requirements


Sec. 850.10  Development and approval of the CBDPP.

    (a) Preparation and submission of initial CBDPP to DOE. (1) The 
responsible employer at a DOE facility must ensure that a CBDPP is 
prepared for the facility and submitted to the appropriate Head of DOE 
Field Element before beginning beryllium activities, but no later than 
April 6, 2000 of this part.
    (2) If the CBDPP has separate sections addressing the activities of 
multiple contractors at the facility, the Head of DOE Field Element 
will designate a single DOE contractor to review and approve the 
sections prepared by other contractors, so that a single consolidated 
CBDPP for the facility is submitted to the Head of DOE Field Element 
for review and approval.
    (b) DOE review and approval. The appropriate Head of DOE Field 
Element must review and approve the CBDPP.
    (1) The initial CBDPP and any updates are deemed approved 90 days 
after submission if they are not specifically approved or rejected by 
DOE earlier.
    (2) The responsible employer must furnish a copy of the approved 
CBDPP, upon request, to the DOE Assistant Secretary for Environment, 
Safety and Health or designee, DOE program offices, and affected 
workers or their designated representatives.
    (c) Update. The responsible employer must submit an update of the 
CBDPP to the appropriate Head of DOE Field Element for review and 
approval whenever a significant change or significant addition to the 
CBDPP is made or a change in contractors occurs. The Head of DOE Field 
Element must review the CBDPP at least annually and, if necessary, 
require the responsible employer to update the CBDPP.
    (d) Labor Organizations. If a responsible employer employs or 
supervises beryllium-associated workers who are represented for 
collective bargaining by a labor organization, the responsible employer 
must:
    (1) Give the labor organization timely notice of the development 
and implementation of the CBDPP and any updates thereto; and
    (2) Upon timely request, bargain concerning implementation of this 
part, consistent with the Federal labor laws.


Sec. 850.11  General CBDPP requirements.

    (a) The CBDPP must specify the existing and planned operational 
tasks that are within the scope of the CBDPP. The CBDPP must augment 
and, to the

[[Page 68907]]

extent feasible, be integrated into the existing worker protection 
programs that cover activities at the facility.
    (b) The detail, scope, and content of the CBDPP must be 
commensurate with the hazard of the activities performed, but in all 
cases the CBDPP must:
    (1) Include formal plans and measures for maintaining exposures to 
beryllium at or below the permissible exposure level prescribed in 
Sec. 850.22;
    (2) Satisfy each requirement in subpart C of this part;
    (3) Contain provisions for:
    (i) Minimizing the number of workers exposed and potentially 
exposed to beryllium;
    (ii) Minimizing the number of opportunities for workers to be 
exposed to beryllium;
    (iii) Minimizing the disability and lost work time of workers due 
to chronic beryllium disease, beryllium sensitization and associated 
medical care; and
    (iv) Setting specific exposure reduction and minimization goals 
that are appropriate for the beryllium activities covered by the CBDPP 
to further reduce exposure below the permissible exposure limit 
prescribed in Sec. 850.22.


Sec. 850.12  Implementation.

    (a) The responsible employer must manage and control beryllium 
exposures in all DOE beryllium activities consistent with the approved 
CBDPP.
    (b) No person employed by DOE or a DOE contractor may take or cause 
any action inconsistent with the requirements of:
    (1) This part,
    (2) An approved CBDPP, and
    (3) Any other Federal statute or regulation concerning the exposure 
of workers to beryllium at DOE facilities.
    (c) No task involving potential exposure to airborne beryllium that 
is outside the scope of the existing CBDPP may be initiated until an 
update of the CBDPP is approved by the Head of DOE Field Element, 
except in an unexpected situation and, then, only upon approval of the 
Head of DOE Field Element.
    (d) Nothing in this part precludes a responsible employer from 
taking any additional protective action that it determines to be 
necessary to protect the health and safety of workers.
    (e) Nothing in this part affects the responsibilities of DOE 
officials under the Federal Employee Occupational Safety and Health 
Program (29 CFR part 1960) and related DOE directives.


Sec. 850.13  Compliance.

    (a) The responsible employer must conduct activities in compliance 
with its CBDPP.
    (b) The responsible employer must achieve compliance with all 
elements of its CBDPP no later than January 7, 2002.
    (c) With respect to a particular beryllium activity, the contractor 
in charge of the activity is responsible for complying with this part. 
If no contractor is responsible for a beryllium activity, DOE must 
ensure implementation of, and compliance with, this part.

Subpart C--Specific Program Requirements


Sec. 850.20  Baseline beryllium inventory.

    (a) The responsible employer must develop a baseline inventory of 
the locations of beryllium operations and other locations of potential 
beryllium contamination, and identify the workers exposed or 
potentially exposed to beryllium at those locations.
    (b) In conducting the baseline inventory, the responsible employer 
must:
    (1) Review current and historical records;
    (2) Interview workers;
    (3) Document the characteristics and locations of beryllium at the 
facility; and
    (4) Conduct air, surface, and bulk sampling.
    (c) The responsible employer must ensure that:
    (1) The baseline beryllium inventory is managed by a qualified 
individual (e.g., a certified industrial hygienist); and
    (2) The individuals assigned to this task have sufficient knowledge 
and experience to perform such activities properly.


Sec. 850.21  Hazard assessment.

    (a) If the baseline inventory establishes the presence of 
beryllium, the responsible employer must conduct a beryllium hazard 
assessment that includes an analysis of existing conditions, exposure 
data, medical surveillance trends, and the exposure potential of 
planned activities. The exposure determinants, characteristics and 
exposure potential of activities must be prioritized so that the 
activities with the greatest risks of exposure are evaluated first.
    (b) The responsible employer must ensure that:
    (1) The hazard assessment is managed by a qualified individual 
(e.g., a certified industrial hygienist); and
    (2) The individuals assigned to this task have sufficient knowledge 
and experience to perform such activities properly.


Sec. 850.22  Permissible exposure limit.

    The responsible employer must assure that no worker is exposed to 
an airborne concentration of beryllium greater than the permissible 
exposure limit established in 29 CFR 1910.1000, as measured in the 
worker's breathing zone by personal monitoring, or a more stringent TWA 
PEL that may be promulgated by the Occupational Safety and Health 
Administration as a health standard.


Sec. 850.23  Action level.

    (a) The responsible employer must include in its CBDPP an action 
level that is no greater than 0.2 g/m3, calculated 
as an 8-hour TWA exposure, as measured in the worker's breathing zone 
by personal monitoring.
    (b) If an airborne concentration of beryllium is at or above the 
action level, the responsible employer must implement Secs. 850.24(c) 
(periodic monitoring), 850.25 (exposure reduction and minimization), 
850.26 (regulated areas), 850.27 (hygiene facilities and practices), 
850.28 (respiratory protection), 850.29 (protective clothing and 
equipment), and 850.38 (warning signs) of this part.


Sec. 850.24  Exposure monitoring.

    (a) General. The responsible employer must ensure that:
    (1) Exposure monitoring is managed by a qualified individual (e.g., 
a certified industrial hygienist); and
    (2) The individuals assigned to this task have sufficient 
industrial hygiene knowledge and experience to perform such activities 
properly.
    (b) Initial monitoring. The responsible employer must perform 
initial monitoring in areas that may have airborne beryllium, as shown 
by the baseline inventory and hazard assessment. The responsible 
employer must apply statistically-based monitoring strategies to obtain 
a sufficient number of sample results to adequately characterize 
exposures, before reducing or terminating monitoring.
    (1) The responsible employer must determine workers' 8-hour TWA 
exposure levels by conducting personal breathing zone sampling.
    (2) Exposure monitoring results obtained within the 12 months 
preceding the effective date of this part may be used to satisfy this 
requirement if the measurements were made as provided in paragraph 
(b)(1) of this section.
    (c) Periodic exposure monitoring. The responsible employer must 
conduct

[[Page 68908]]

periodic monitoring of workers who work in areas where airborne 
concentrations of beryllium are at or above the action level. The 
monitoring must be conducted in a manner and at a frequency necessary 
to represent workers' exposure, as specified in the CBDPP. This 
periodic exposure monitoring must be performed at least every 3 months 
(quarterly).
    (d) Additional exposure monitoring. The responsible employer must 
perform additional monitoring if operations, maintenance or procedures 
change, or when the responsible employer has any reason to suspect such 
a change has occurred.
    (e) Accuracy of monitoring. The responsible employer must use a 
method of monitoring and analysis that has an accuracy of not less than 
plus or minus 25 percent, with a confidence level of 95 percent, for 
airborne concentrations of beryllium at the action level.
    (f) Analysis. The responsible employer must have all samples 
collected to satisfy the monitoring requirements of this part analyzed 
in a laboratory accredited for metals by the American Industrial 
Hygiene Association (AIHA) or a laboratory that demonstrates quality 
assurance for metals analysis that is equivalent to AIHA accreditation.
    (g) Notification of monitoring results. (1) The responsible 
employer must, within 10 working days after receipt of any monitoring 
results, notify the affected workers of monitoring results in writing. 
This notification of monitoring results must be:
    (i) Made personally to the affected worker; or
    (ii) Posted in location(s) that is readily accessible to the 
affected worker, but in a manner that does not identify the individual 
to other workers.
    (2) If the monitoring results indicate that a worker's exposure is 
at or above the action level, the responsible employer must include in 
the notice:
    (i) A statement that the action level has been met or exceeded; and
    (ii) A description of the corrective action being taken by the 
responsible employer to reduce the worker's exposure to below the 
action level, if practicable.
    (3) If the monitoring results indicate that worker exposure is at 
or above the action level, the responsible employer must also notify 
DOE and the SOMD of these results within 10 working days after receipt.


Sec. 850. 25  Exposure reduction and minimization.

    (a) The responsible employer must ensure that no worker is exposed 
above the exposure limit prescribed in Sec. 850.22.
    (b) The responsible employer must, in addition:
    (1) Where exposure levels are at or above the action level, 
establish a formal exposure reduction and minimization program to 
reduce exposure levels to below the action level, if practicable. This 
program must be described in the responsible employer's CBDPP and must 
include:
    (i) Annual goals for exposure reduction and minimization;
    (ii) A rationale for and a strategy for meeting the goals;
    (iii) Actions that will be taken to achieve the goals; and
    (iv) A means of tracking progress towards meeting the goals or 
demonstrating that the goals have been met.
    (2) Where exposure levels are below the action level, implement 
actions for reducing and minimizing exposures, if practicable. The 
responsible employer must include in the CBDPP a description of the 
steps to be taken for exposure reduction and minimization and a 
rationale for those steps.
    (c) The responsible employer must implement exposure reduction and 
minimization actions using the conventional hierarchy of industrial 
hygiene controls (i.e., engineering controls, administrative controls, 
and personal protective equipment in that order).


Sec. 850.26  Regulated areas.

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


Sec. 850.27  Hygiene facilities and practices.

    (a) General. The responsible employer must assure that in areas 
where workers are exposed to beryllium at or above the action level, 
without regard to the use of respirators:
    (1) Food or beverage and tobacco products are not used;
    (2) Cosmetics are not applied, except in change rooms or areas and 
shower facilities required under paragraphs (b) and (c) of this 
section; and
    (3) Beryllium workers are prevented from exiting areas that contain 
beryllium with contamination on their bodies or their personal 
clothing.
    (b) Change rooms or areas. The responsible employer must provide 
clean change rooms or areas for beryllium workers who work in regulated 
areas.
    (1) Separate facilities free of beryllium must be provided for 
beryllium workers to change into, and store, personal clothing, and 
clean protective clothing and equipment to prevent cross-contamination;
    (2) The change rooms or areas that are used to remove beryllium-
contaminated clothing and protective equipment must be maintained under 
negative pressure or located so as to minimize dispersion of beryllium 
into clean areas; and
    (c) Showers and handwashing facilities. (1) The responsible 
employer must provide handwashing and shower facilities for beryllium 
workers who work in regulated areas.
    (2) The responsible employer must assure that beryllium workers who 
work in regulated areas shower at the end of the work shift.
    (d) Lunchroom facilities. (1) The responsible employer must provide 
lunchroom facilities that are readily accessible to beryllium workers, 
and ensure that tables for eating are free of beryllium, and that no 
worker in a lunchroom facility is exposed at any time to beryllium at 
or above the action level.
    (2) The responsible employer must assure that beryllium workers do 
not enter lunchroom facilities with protective work clothing or 
equipment unless the surface beryllium has been removed from clothing 
and equipment by HEPA vacuuming or other method that removes beryllium 
without dispersing it.
    (e) The change rooms or areas, shower and handwashing facilities, 
and lunchroom facilities must comply with 29 CFR 1910.141, Sanitation.


Sec. 850.28  Respiratory protection.

    (a) The responsible employer must establish a respiratory 
protection program that complies with the respiratory protection 
program requirements of 29 CFR 1910.134, Respiratory Protection.
    (b) The responsible employer must provide respirators to, and 
ensure that they are used by, all workers who:

[[Page 68909]]

    (1) Are exposed to an airborne concentration of beryllium at or 
above the action level, or
    (2) Are performing tasks for which analyses indicate the potential 
for exposures at or above the action level.
    (c) The responsible employer must include in the respiratory 
protection program any beryllium-associated worker who requests to use 
a respirator for protection against airborne beryllium, regardless of 
measured exposure levels.
    (d) The responsible employer must select for use by workers:
    (1) Respirators approved by the National Institute for Occupational 
Safety and Health (NIOSH) if NIOSH-approved respirators exist for a 
specific DOE task; or
    (2) Respirators that DOE has accepted under the DOE Respiratory 
Protection Acceptance Program if NIOSH-approved respirators do not 
exist for specific DOE tasks.


Sec. 850.29  Protective clothing and equipment.

    (a) The responsible employer must provide protective clothing and 
equipment to beryllium workers and ensure its appropriate use and 
maintenance, where dispersible forms of beryllium may contact worker's 
skin, enter openings in workers' skin, or contact workers' eyes, 
including where:
    (1) Exposure monitoring has established that airborne 
concentrations of beryllium are at or above the action level;
    (2) Surface contamination levels measured or presumed prior to 
initiating work are above the level prescribed in Sec. 850.30;
    (3) Surface contamination levels results obtained to confirm 
housekeeping efforts are above the level prescribed in Sec. 850.30; and
    (4) Any beryllium-associated worker who requests the use of 
protective clothing and equipment for protection against airborne 
beryllium, regardless of measured exposure levels.
    (b) The responsible employer must comply with 29 CFR 1910.132, 
Personal Protective Equipment General Requirements, when workers use 
personal protective clothing and equipment.
    (c) The responsible employer must establish procedures for donning, 
doffing, handling, and storing protective clothing and equipment that:
    (1) Prevent beryllium workers from exiting areas that contain 
beryllium with contamination on their bodies or their personal 
clothing; and
    (2) Include beryllium workers exchanging their personal clothing 
for full-body protective clothing and footwear before they begin work 
in regulated areas.
    (d) The responsible employer must ensure that no worker removes 
beryllium-contaminated protective clothing and equipment from areas 
that contain beryllium, except for workers authorized to launder, 
clean, maintain, or dispose of the clothing and equipment.
    (e) The responsible employer must prohibit the removal of beryllium 
from protective clothing and equipment by blowing, shaking, or other 
means that may disperse beryllium into the air.
    (f) The responsible employer must ensure that protective clothing 
and equipment is cleaned, laundered, repaired, or replaced as needed to 
maintain effectiveness. The responsible employer must:
    (1) Ensure that beryllium-contaminated protective clothing and 
equipment, when removed for laundering, cleaning, maintenance, or 
disposal, is placed in containers that prevent the dispersion of 
beryllium dust and that are labeled in accordance with Sec. 850.38 of 
this part; and
    (2) Inform organizations that launder or clean DOE beryllium-
contaminated protective clothing or equipment that exposure to 
beryllium is potentially harmful, and that clothing and equipment 
should be laundered or cleaned in a manner prescribed by the 
responsible employer to prevent the release of airborne beryllium.


Sec. 850.30  Housekeeping.

    (a) Where beryllium is present in operational areas of DOE 
facilities, the responsible employer must conduct routine surface 
sampling to determine housekeeping conditions. Surfaces contaminated 
with beryllium dusts and waste must not exceed a removable 
contamination level of 3 g/100 cm\2\ during non-operational 
periods. This sampling would not include the interior of installed 
closed systems such as enclosures, glove boxes, chambers, or 
ventilation systems.
    (b) When cleaning floors and surfaces in areas where beryllium is 
present at DOE facilities, the responsible employer must clean 
beryllium-contaminated floors and surfaces using a wet method, 
vacuuming or other cleaning methods, such as sticky tack cloths, that 
avoid the production of airborne dust. Compressed air or dry methods 
must not be used for such cleaning.
    (c) The responsible employer must equip the portable or mobile 
vacuum units that are used to clean beryllium-contaminated areas with 
HEPA filters, and change the filters as often as needed to maintain 
their capture efficiency.
    (d) The responsible employer must ensure that the cleaning 
equipment that is used to clean beryllium-contaminated surfaces is 
labeled, controlled, and not used for non-hazardous materials.


Sec. 850.31  Release criteria.

    (a) The responsible employer must clean beryllium-contaminated 
equipment and other items to the lowest contamination level 
practicable, but not to exceed the levels established in paragraphs (b) 
and (c) of this section, and label the equipment or other items, before 
releasing them to the general public or a DOE facility for non-
beryllium use, or to another facility for work involving beryllium.
    (b) Before releasing beryllium-contaminated equipment or other 
items to the general public or for use in a non-beryllium area of a DOE 
facility, the responsible employer must ensure that:
    (1) The removable contamination level of equipment or item surfaces 
does not exceed the higher of 0.2 g/100 cm \2\ or the 
concentration level of beryllium in soil at the point or release, 
whichever is greater;
    (2) The equipment or item is labeled in accordance with 
Sec. 850.38(b); and
    (3) The release is conditioned on the recipient's commitment to 
implement controls that will prevent foreseeable beryllium exposure, 
considering the nature of the equipment or item and its future use and 
the nature of the beryllium contamination.
    (c) Before releasing beryllium-contaminated equipment or other 
items to another facility performing work with beryllium, the 
responsible employer must ensure that:
    (1) The removable contamination level of equipment or item surfaces 
does not exceed 3 g/100 cm \2\;
    (2) The equipment or item is labeled in accordance with 
Sec. 850.38(b); and
    (3) The equipment or item is enclosed or placed in sealed, 
impermeable bags or containers to prevent the release of beryllium dust 
during handling and transportation.


Sec. 850.32  Waste disposal.

    (a) The responsible employer must control the generation of 
beryllium-containing waste, and beryllium-contaminated equipment and 
other items that are disposed of as waste, through the application of 
waste minimization principles.
    (b) Beryllium-containing waste, and beryllium-contaminated 
equipment and other items that are disposed of as waste, must be 
disposed of in sealed, impermeable bags, containers, or

[[Page 68910]]

enclosures to prevent the release of beryllium dust during handling and 
transportation. The bags, containers, and enclosures that are used for 
disposal of beryllium waste must be labeled according to Sec. 850.38.


Sec. 850.33  Beryllium emergencies.

    (a) The responsible employer must comply with 29 CFR 1910.120(l) 
for handling beryllium emergencies related to decontamination and 
decommissioning operations.
    (b) The responsible employer must comply with 29 CFR 1910.120(q) 
for handling beryllium emergencies related to all other operations.


Sec. 850.34  Medical surveillance.

    (a) General. (1) The responsible employer must establish and 
implement a medical surveillance program for beryllium-associated 
workers who voluntarily participate in the program.
    (2) The responsible employer must designate a Site Occupational 
Medical Director (SOMD) who is responsible for administering the 
medical surveillance program.
    (3) The responsible employer must ensure that the medical 
evaluations and procedures required by this section are performed by, 
or under the supervision of, a licensed physician who is familiar with 
the health effects of beryllium.
    (4) The responsible employer must establish, and maintain, a list 
of beryllium-associated workers who may be eligible for protective 
measures under this part. The list must be:
    (i) Based on the hazard assessment, exposure records, and other 
information regarding the identity of beryllium-associated workers; and
    (ii) Adjusted at regular intervals based on periodic evaluations of 
beryllium-associated workers performed under paragraph (b)(2) of this 
section;
    (5) The responsible employer must provide the SOMD with the 
information needed to operate and administer the medical surveillance 
program, including the:
    (i) List of beryllium-associated workers required by paragraph 
(a)(4) of this section;
    (ii) Baseline inventory;
    (iii) Hazard assessment and exposure monitoring data;
    (iv) Identity and nature of activities or operations on the site 
that are covered under the CBDPP, related duties of beryllium-
associated workers; and
    (v) Type of personal protective equipment used.
    (6) The responsible employer must provide the following information 
to the SOMD and the examining physician:
    (i) A copy of this rule and its preamble;
    (ii) A description of the worker's duties as they pertain to 
beryllium exposure;
    (iii) Records of the worker's beryllium exposure; and
    (iv) A description of the personal protective and respiratory 
protective equipment used by the worker in the past, present, or 
anticipated future use.
    (b) Medical evaluations and procedures. The responsible employer 
must provide, to beryllium-associated workers who voluntarily 
participate in the medical surveillance program, the medical 
evaluations and procedures required by this section at no cost and at a 
time and place that is reasonable and convenient to the worker.
    (1) Baseline medical evaluation. The responsible employer must 
provide a baseline medical evaluation to beryllium-associated workers. 
This evaluation must include:
    (i) A detailed medical and work history with emphasis on past, 
present, and anticipated future exposure to beryllium;
    (ii) A respiratory symptoms questionnaire;
    (iii) A physical examination with special emphasis on the 
respiratory system, skin and eyes;
    (iv) A chest radiograph (posterior-anterior, 14 x 17 inches) 
interpreted by a National Institute for Occupational Safety and Health 
(NIOSH) B-reader of pneumoconiosis or a board-certified radiologist 
(unless a baseline chest radiograph is already on file);
    (v) Spirometry consisting of forced vital capacity (FVC) and forced 
expiratory volume at 1 second (FEV1);
    (vi) A Be-LPT; and
    (vii) Any other tests deemed appropriate by the examining physician 
for evaluating beryllium-related health effects.
    (2) Periodic evaluation. (i) The responsible employer must provide 
to beryllium workers a medical evaluation annually, and to other 
beryllium-associated workers a medical evaluation every three years. 
The periodic medical evaluation must include:
    (A) A detailed medical and work history with emphasis on past, 
present, and anticipated future exposure to beryllium;
    (B) A respiratory symptoms questionnaire;
    (C) A physical examination with emphasis on the respiratory system;
    (D) A Be-LPT; and
    (E) Any other medical evaluations deemed appropriate by the 
examining physician for evaluating beryllium-related health effects.
    (ii) The responsible employer must provide to beryllium-associated 
workers a chest radiograph every five years.
    (3) Emergency evaluation. The responsible employer must provide a 
medical evaluation as soon as possible to any worker who may have been 
exposed to beryllium because of a beryllium emergency. The medical 
evaluation must include the requirements of paragraph (b)(2) of this 
section.
    (c) Multiple physician review. The responsible employer must 
establish a multiple physician review process for beryllium-associated 
workers that allows for the review of initial medical findings, 
determinations, or recommendations from any medical evaluation 
conducted pursuant to paragraph (b) of this section.
    (1) If the responsible employer selects the initial physician to 
conduct any medical examination or consultation provided to a 
beryllium-associated worker, the worker may designate a second 
physician to:
    (i) Review any findings, determinations, or recommendations of the 
initial physician; and
    (ii) Conduct such examinations, consultations and laboratory tests, 
as the second physician deems necessary to facilitate this review.
    (2) The responsible employer must promptly notify a beryllium-
associated worker in writing of the right to seek a second medical 
opinion after the initial physician provided by the responsible 
employer conducts a medical examination or consultation.
    (3) The responsible employer may condition its participation in, 
and payment for, multiple physician review upon the beryllium-
associated worker doing the following within fifteen (15) days after 
receipt of the notice, or receipt of the initial physician's written 
opinion, whichever is later:
    (i) Informing the responsible employer in writing that he or she 
intends to seek a second medical opinion; and
    (ii) Initiating steps to make an appointment with a second 
physician.
    (4) If the findings, determinations, or recommendations of the 
second physician differ from those of the initial physician, then the 
responsible employer and the beryllium-associated worker must make 
efforts to encourage and assist the two physicians to resolve any 
disagreement.
    (5) If, despite the efforts of the responsible employer and the 
beryllium-associated worker, the two physicians are unable to resolve 
their disagreement, then the responsible employer and the worker, 
through their respective physicians, must designate a third physician 
to:

[[Page 68911]]

    (i) Review any findings, determinations, or recommendations of the 
other two physicians; and
    (ii) Conduct such examinations, consultations, laboratory tests, 
and consultations with the other two physicians, as the third physician 
deems necessary to resolve the disagreement among them.
    (6) The SOMD must act consistently with the findings, 
determinations, and recommendations of the third physician, unless the 
SOMD and the beryllium-associated worker reach an agreement that is 
consistent with the recommendations of at least one of the other two 
physicians.
    (d) Alternate physician determination. The responsible employer and 
the beryllium-associated worker or the worker's designated 
representative may agree upon the use of any alternate form of 
physician determination in lieu of the multiple physician review 
process provided by paragraph (c) of this section, so long as the 
alternative is expeditious and at least as protective of the worker.
    (e) Written medical opinion and recommendation. (1) Within two 
weeks of receipt of results, the SOMD must provide to the responsible 
employer a written, signed medical opinion for each medical evaluation 
performed on each beryllium-associated worker. The written opinion must 
take into account the findings, determinations and recommendations of 
the other examining physicians who may have examined the beryllium-
associated worker. The SOMD's opinion must contain:
    (i) The diagnosis of the worker's condition relevant to 
occupational exposure to beryllium, and any other medical condition 
that would place the worker at increased risk of material impairment to 
health from further exposure to beryllium;
    (ii) Any recommendation for removal of the worker from DOE 
beryllium activities, or limitation on the worker's activities or 
duties or use of personal protective equipment, such as a respirator; 
and
    (iii) A statement that the SOMD or examining physician has clearly 
explained to the worker the results of the medical evaluation, 
including all tests results and any medical condition related to 
beryllium exposure that requires further evaluation or treatment.
    (2) The SOMD's written medical opinion must not reveal specific 
records, findings, and diagnoses that are not related to medical 
conditions that may be affected by beryllium exposure.
    (f) Information provided to the beryllium-associated worker. (1) 
The SOMD must provide each beryllium-associated worker with a written 
medical opinion containing the results of all medical tests or 
procedures, an explanation of any abnormal findings, and any 
recommendation that the worker be referred for additional testing for 
evidence of CBD, within 10 working days after the SOMD's receipt of the 
results of the medical tests or procedures.
    (2) The responsible employer must, within 30 days after a request 
by a beryllium-associated worker, provide the worker with the 
information the responsible employer is required to provide the 
examining physician under paragraph (a)(6) of this section.
    (g) Reporting. The responsible employer must report on the 
applicable OSHA reporting form beryllium sensitization, CBD, or any 
other abnormal condition or disorder of workers caused or aggravated by 
occupational exposure to beryllium.
    (h) Data analysis. (1) The responsible employer must routinely and 
systematically analyze medical, job, and exposure data with the aim of 
identifying individuals or groups of individuals potentially at risk 
for CBD and working conditions that are contributing to that risk.
    (2) The responsible employer must use the results of these analyses 
to identify additional workers to whom the responsible employer must 
provide medical surveillance and to determine the need for additional 
exposure controls.


Sec. 850.35  Medical removal.

    (a) Medical removal protection. The responsible employer must offer 
a beryllium-associated worker medical removal from exposure to 
beryllium if the SOMD determines in a written medical opinion that it 
is medically appropriate to remove the worker from such exposure. The 
SOMD's determination must be based on one or more positive Be-LPT 
results, chronic beryllium disease diagnosis, an examining physician's 
recommendation, or any other signs or symptoms that the SOMD deems 
medically sufficient to remove a worker.
    (1) Temporary removal pending final medical determination. The 
responsible employer must offer a beryllium-associated worker temporary 
medical removal from exposure to beryllium on each occasion that the 
SOMD determines in a written medical opinion that the worker should be 
temporarily removed from such exposure pending a final medical 
determination of whether the worker should be removed permanently.
    (i) In this section, ``final medical determination'' means the 
outcome of the multiple physician review process or the alternate 
medical determination process provided for in paragraphs (c) and (d) of 
Sec. 850.34.
    (ii) If a beryllium-associated worker is temporarily removed from 
beryllium exposure pursuant to this section, the responsible employer 
must transfer the worker to a comparable job for which the worker is 
qualified (or for which the worker can be trained in a short period) 
and where beryllium exposures are as low as possible, but in no event 
at or above the action level.
    (iii) The responsible employer must maintain the beryllium-
associated worker's total normal earnings, seniority, and other worker 
rights and benefits as if the worker had not been removed.
    (iv) If there is no such job available, the responsible employer 
must provide to the beryllium-associated worker the medical removal 
protection benefits specified in paragraph (b)(2) of this section, 
until a job becomes available or for one year, whichever comes first.
    (2) Permanent medical removal. (i) The responsible employer must 
offer a beryllium-associated worker permanent medical removal from 
exposure to beryllium if the SOMD determines in a written medical 
opinion that the worker should be permanently removed from exposure to 
beryllium.
    (ii) If a beryllium-associated worker is removed permanently from 
beryllium exposure based on the SOMD's recommendation pursuant to this 
section, the responsible employer must provide the worker the medical 
removal protection benefits specified in paragraph (b) of this section.
    (3) Worker consultation before temporary or permanent medical 
removal. If the SOMD determines that a beryllium-associated worker 
should be temporarily or permanently removed from exposure to 
beryllium, the SOMD must:
    (i) Advise the beryllium-associated worker of the determination 
that medical removal is necessary to protect the worker's health;
    (ii) Provide the beryllium-associated worker with a copy of this 
rule and its preamble, and any other information the SOMD deems 
necessary on the risks of continued exposure to beryllium and the 
benefits of removal;
    (iii) Provide the beryllium-associated worker the opportunity to 
have any questions concerning medical removal answered; and
    (iv) Obtain the beryllium-associated worker's signature 
acknowledging that the worker has been advised to accept

[[Page 68912]]

medical removal from beryllium exposure as provided in this section, 
and has been provided with the information specified in this paragraph, 
on the benefits of removal and the risks of continued exposure to 
beryllium.
    (4) Return to work after medical removal. (i) The responsible 
employer, subject to paragraph (a)(4)(ii) of this section, must not 
return a beryllium-associated worker who has been permanently removed 
under this section to the worker's former job status unless the SOMD 
first determines in a written medical opinion that continued medical 
removal is no longer necessary to protect the worker's health.
    (ii) Not withstanding paragraph (a)(4) (i) of this section, if, in 
the SOMD's opinion, continued exposure to beryllium will not pose an 
increased risk to the beryllium-associated worker's health, and medical 
removal is an inappropriate remedy in the circumstances, the SOMD must 
fully discuss these matters with the worker and then, in a written 
determination, may authorize the responsible employer to return the 
worker to his or her former job status. Thereafter, the returned 
beryllium-associated worker must continue to be provided with medical 
surveillance under Sec. 850.34 of this part.
    (b) Medical removal protection benefits. (1) If a beryllium-
associated worker has been permanently removed from beryllium exposure 
pursuant to paragraph (a)(2) of this section, the responsible employer 
must provide the beryllium-associated worker:
    (i) The opportunity to transfer to another position which is 
available, or later becomes available, for which the beryllium-
associated worker is qualified (or for which the worker can be trained 
in a short period) and where beryllium exposures are as low as 
possible, but in no event at or above the action level; or
    (ii) If the beryllium-associated worker cannot be transferred to a 
comparable job where beryllium exposures are below the action level, a 
maximum of 2 years of permanent medical removal protection benefits 
(specified in paragraph (b)(2) of this section).
    (2) If required by this section to provide medical removal 
protection benefits, the responsible employer must maintain the removed 
worker's total normal earnings, seniority and other worker rights and 
benefits, as though the worker had not been removed.
    (3) If a removed beryllium-associated worker files a claim for 
workers' compensation payments for a beryllium-related disability, then 
the responsible employer must continue to provide medical removal 
protection benefits pending disposition of the claim. The responsible 
employer must receive no credit for the workers' compensation payments 
received by the worker for treatment related expenses.
    (4) The responsible employer's obligation to provide medical 
removal protection benefits to a removed beryllium-associated worker is 
reduced to the extent that the worker receives compensation for 
earnings lost during the period of removal either from a publicly- or 
employer-funded compensation program, or from employment with another 
employer made possible by virtue of the worker's removal.
    (5) For the purposes of this section, the requirement that a 
responsible employer provide medical removal protection benefits is not 
intended to expand upon, restrict, or change any rights to a specific 
job classification or position under the terms of an applicable 
collective bargaining agreement.
    (6) The responsible employer may condition the provision of medical 
removal protection benefits upon the beryllium-associated worker's 
participation in medical surveillance provided in accordance with 
Sec. 850.34 of this part.


Sec. 850.36  Medical consent.

    (a) The responsible employer must provide each beryllium-associated 
worker with a summary of the medical surveillance program established 
in Sec. 850.34 at least one week before the first medical evaluation or 
procedure or at any time requested by the worker. This summary must 
include:
    (1) The type of data that will be collected in the medical 
surveillance program;
    (2) How the data will be collected and maintained;
    (3) The purpose for which the data will be used; and
    (4) A description of how confidential data will be protected.
    (b) Responsible employers must also provide each beryllium-
associated worker with information on the benefits and risks of the 
medical tests and examinations available to the worker at least one 
week prior to any such examination or test, and an opportunity to have 
the worker's questions answered.
    (c) The responsible employer must have the SOMD obtain a beryllium-
associated worker's signature on the informed consent form found in 
Appendix A to this part, before performing medical evaluations or any 
tests.


Sec. 850.37  Training and counseling.

    (a) The responsible employer must develop and implement a beryllium 
training program and ensure participation for:
    (1) Beryllium-associated workers;
    (2) All other individuals who work at a site where beryllium 
activities are conducted.
    (b) The training provided for workers identified in paragraph 
(a)(1) of this section, must:
    (1) Be in accordance with 29 CFR 1910.1200, Hazard Communication;
    (2) Include the contents of the CBDPP; and
    (3) Include potential health risks to beryllium worker family 
members and others who may come in contact with beryllium on beryllium 
workers or beryllium workers' personal clothing or other personal items 
as the result of a beryllium control failure at a DOE facility.
    (c) The training provided for workers identified in paragraph 
(a)(2) of this section must consist of general awareness about 
beryllium hazards and controls.
    (d) The responsible employer must provide the training required by 
this section before or at the time of initial assignment and at least 
every two years thereafter.
    (e) The employer must provide retraining when the employer has 
reason to believe that a beryllium worker lacks the proficiency, 
knowledge, or understanding needed to work safely with beryllium, 
including at least the following situations:
    (1) To address any new beryllium hazards resulting from a change to 
operations, procedures, or beryllium controls about which the beryllium 
worker was not previously trained; and
    (2) If a beryllium worker's performance involving beryllium work 
indicates that the worker has not retained the requisite proficiency.
    (f) The responsible employer must develop and implement a 
counseling program to assist beryllium-associated workers who are 
diagnosed by the SOMD to be sensitized to beryllium or to have CBD. 
This counseling program must include communicating with beryllium-
associated workers concerning:
    (1) The medical surveillance program provisions and procedures;
    (2) Medical treatment options;
    (3) Medical, psychological, and career counseling;
    (4) Medical benefits;
    (5) Administrative procedures and workers rights under applicable 
Workers' Compensation laws and regulations;

[[Page 68913]]

    (6) Work practice procedures limiting beryllium-associated worker 
exposure to beryllium; and
    (7) The risk of continued beryllium exposure after sensitization.


Sec. 850.38  Warning signs and labels.

    (a) Warning signs. The responsible employer must post warning signs 
at each access point to a regulated area with the following 
information:

DANGER
BERYLLIUM CAN CAUSE LUNG DAMAGE
CANCER HAZARD
AUTHORIZED PERSONNEL ONLY
    (b) Warning labels. (1) The responsible employer must affix warning 
labels to all containers of beryllium, beryllium compounds, or 
beryllium-contaminated clothing, equipment, waste, scrap, or debris.
    (2) Warning labels must contain the following information:

DANGER
CONTAMINATED WITH BERYLLIUM
DO NOT REMOVE DUST BY BLOWING OR SHAKING
CANCER AND LUNG DISEASE HAZARD
    (c) Warning signs and labels must be in accordance with 29 CFR 
1910.1200, Hazard Communication.


Sec. 850. 39  Recordkeeping and use of information.

    (a) The responsible employer must establish and maintain accurate 
records of all beryllium inventory information, hazard assessments, 
exposure measurements, exposure controls, and medical surveillance.
    (b) Heads of DOE Departmental Elements must:
    (1) Designate all record series as required under this rule as 
agency records and, therefore, subject to all applicable agency records 
management and access laws; and
    (2) Ensure that these record series are retained for a minimum of 
seventy-five years.
    (c) The responsible employer must convey to DOE or its designee all 
record series required under this rule if the employer ceases to be 
involved in the CBDPP.
    (d) The responsible employer must link data on workplace conditions 
and health outcomes in order to establish a basis for understanding the 
beryllium health risk.
    (e) The responsible employer must ensure the confidentiality of all 
work-related records generated under this rule by ensuring that:
    (1) All records that are transmitted to other parties do not 
contain names, social security numbers or any other variables, or 
combination of variables, that could be used to identify particular 
individuals; and
    (2) Individual medical information generated by the CBDPP is:
    (i) Either included as part of the worker's site medical records 
and maintained by the SOMD, or is maintained by another physician 
designated by the responsible employer;
    (ii) Maintained separately from other records; and
    (iii) Used or disclosed by the responsible employer only in 
conformance with any applicable requirements imposed by the Americans 
with Disabilities Act, the Privacy Act of 1974, the Freedom of 
Information Act, and any other applicable law.
    (f) The responsible employer must maintain all records required by 
this part in current and accessible electronic systems, which include 
the ability readily to retrieve data in a format that maintains 
confidentiality.
    (g) The responsible employer must transmit all records generated as 
required by this rule, in a format that protects the confidentiality of 
individuals, to the DOE Assistant Secretary for Environment, Safety and 
Health on request.
    (h) The responsible employer must semi-annually transmit to the DOE 
Office of Epidemiologic Studies within the Office of Environment, 
Safety and Health an electronic registry of beryllium-associated 
workers that protects confidentiality, and the registry must include, 
but is not limited to, a unique identifier, date of birth, gender, 
site, job history, medical screening test results, exposure 
measurements, and results of referrals for specialized medical 
evaluations.


Sec. 850.40  Performance feedback.

    (a) The responsible employer must conduct periodic analyses and 
assessments of monitoring activities, hazards, medical surveillance, 
exposure reduction and minimization, and occurrence reporting data.
    (b) To ensure that information is available to maintain and improve 
all elements of the CBDPP continuously, the responsible employer must 
give results of periodic analyses and assessments to the line managers, 
planners, worker protection staff, workers, medical staff, and labor 
organizations representing beryllium-associated workers who request 
such information.

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

    I, ______________ have carefully read and understand the 
attached information about the Be-LPT and other medical tests. I 
have had the opportunity to ask any questions that I may have had 
concerning these tests.
    I understand that this program is voluntary and I am free to 
withdraw at any time from all or any part of the medical 
surveillance program. I understand that the tests are confidential, 
but not anonymous. I understand that if the results of any test 
suggest a health problem, the examining physician will discuss the 
matter with me, whether or not the result is related to my work with 
beryllium. I understand that my employer will be notified of my 
diagnosis only if I have a beryllium sensitization or chronic 
beryllium disease. My employer will not receive the results or 
diagnoses of any health conditions not related to beryllium 
exposure.
    I understand that, if the results of one or more of these tests 
indicate that I have a health problem that is related to beryllium, 
additional examinations will be recommended. If additional tests 
indicate I do have a beryllium sensitization or CBD, the Site 
Occupational Medical Director may recommend that I be removed from 
working with beryllium. If I agree to be removed, I understand that 
I may be transferred to another job for which I am qualified (or can 
be trained for in a short period) and where my beryllium exposures 
will be as low as possible, but in no case above the action level. I 
will maintain my total normal earnings, seniority, and other 
benefits for up to two years if I agree to be permanently removed.
    I understand that if I apply for another job or for insurance, I 
may be requested to release my medical records to a future employer 
or an insurance company.
    I understand that my employer will maintain all medical 
information relative to the tests performed on me in segregated 
medical files separate from my personnel files, treated as 
confidential medical records, and used or disclosed only as provided 
by the Americans with Disability Act, the Privacy Act of 1974, or as 
required by a court order or under other law.
    I understand that the results of my medical tests for beryllium 
will be included in the Beryllium Registry maintained by DOE, and 
that a unique identifier will be used to maintain the 
confidentiality of my medical information. Personal identifiers will 
not be included in any reports generated from the DOE Beryllium 
Registry. I understand that the results of my tests and examinations 
may be published in reports or presented at meetings, but that I 
will not be identified.
    I consent to having the following medical evaluations:

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

[[Page 68914]]

----------------------------------------------------------------------

Signature of Participant:
----------------------------------------------------------------------

Date: ____________

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

Name of Examining Physician:
----------------------------------------------------------------------

Signature of Examining Physician:
----------------------------------------------------------------------

Dated: ____________

[FR Doc. 99-31181 Filed 12-6-99; 8:45 am]
BILLING CODE 6450-01-P