Asbestos Exposure Limit, 43950-43989 [05-14510]
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Federal Register / Vol. 70, No. 145 / Friday, July 29, 2005 / Proposed Rules
DEPARTMENT OF LABOR
Mine Safety and Health Administration
30 CFR Parts 56, 57, and 71
RIN: 1219–AB24
Asbestos Exposure Limit
Mine Safety and Health
Administration (MSHA), Labor.
ACTION: Proposed rule; notice of public
hearings.
AGENCY:
SUMMARY: We (MSHA) are proposing to
revise our existing health standards for
asbestos exposure at metal and
nonmetal mines, surface coal mines,
and surface areas of underground coal
mines. The proposed rule would reduce
the full-shift permissible exposure limit
and the excursion limit for airborne
asbestos fibers, and make several
nonsubstantive changes to add clarity to
the standard. Exposure to asbestos has
been associated with lung and other
cancers, mesotheliomas, and asbestosis.
This proposed rule would help assure
that fewer miners who work in an
environment where asbestos is present
would suffer material impairment of
health or functional capacity over their
working lifetime.
DATES: We must receive your comments
on or before September 20, 2005. We
will hold public hearings on October 18
and 20. Details about the public
hearings are in the SUPPLEMENTARY
INFORMATION section of this preamble.
ADDRESSES: (1) To submit comments,
please include ‘‘RIN: 1219–AB24’’ in the
subject line of the message and send
them to us at either of the following
addresses.
• Federal e-Rulemaking portal: Go to
https://www.regulations.gov and follow
the online instructions for submitting
comments.
• E-mail: zzMSHA-comments@dol.gov.
If you are unable to submit comments
electronically, please identify them by
‘‘RIN: 1219–AB24’’ and send them to us
by any of the following methods.
• Fax: 202–693–9441.
• Mail, hand delivery, or courier:
MSHA, Office of Standards,
Regulations, and Variances, 1100
Wilson Blvd., Rm. 2350, Arlington, VA
22209–3939.
(2) We will post all comments on the
Internet without change, including any
personal information they may contain.
You may access the rulemaking docket
via the Internet at https://www.msha.gov/
regsinfo.htm or in person at MSHA’s
public reading room at 1100 Wilson
Blvd., Rm. 2349, Arlington, VA.
(3) To receive an e-mail notification
when we publish rulemaking
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documents in the Federal Register,
subscribe to our list serve at https://
www.msha.gov/subscriptions/
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FOR FURTHER INFORMATION CONTACT:
Rebecca J. Smith at 202–693–9440
(Voice), 202–693–9441 (Fax), or
mailto:smith.rebecca@dol.gov (E-mail).
SUPPLEMENTARY INFORMATION:
I. Introduction
A. Outline of Preamble
We are including the following
outline to help you find information in
this preamble more quickly.
I. Introduction
A. Outline of Preamble
B. Dates and Locations for Public Hearings
C. Executive Summary
D. Abbreviations and Acronyms
II. Background
A. Scope of Proposed Rule
B. Where Asbestos Is Found at Mining
Operations
C. Asbestos Minerals
III. History of Asbestos Regulation
A. MSHA’s Asbestos Standards for Mining
B. OSHA’s Asbestos Standards for General
Industry and Construction
C. Other Federal Agencies Regulating
Asbestos
D. Other Asbestos-Related Activities
E. U.S. Department of Labor, Office of the
Inspector General (OIG)
IV. Health Effects of Asbestos Exposure
A. Summary of Asbestos Health Hazards
B. Factors Affecting the Occurrence and
Severity of Disease
C. Specific Human Health Effects
D. Support from Toxicological Studies of
Human Health Effects of Asbestos
Exposure
V. Characterization and Assessment of
Exposures in Mining
A. Determining Asbestos Exposures in
Mining
B. Exposures from Naturally Occurring
Asbestos
C. Exposures from Introduced
(Commercial) Asbestos
D. Sampling Data and Exposure
Calculations
VI. The Application of OSHA’s Risk
Assessment to Mining
A. Summary of Studies Used by OSHA in
Its Risk Assessment
B. Models Selected by OSHA (1986) for
Specified Endpoints and for the
Determination of Its PEL and STEL
C. OSHA’s Selection of Its PEL (0.1 f/cc)
D. Applicability of OSHA’s Risk
Assessment to the Mining Industry
E. Significance of Risk
VII. Section-by-Section Discussion of
Proposed Rule
A. Sections 56/57.5001(b)(1) and 71.702(a):
Definitions
B. Sections 56/57.5001(b)(2) and 71.702(b):
Permissible Exposure Limits (PELs)
C. Sections 56/57.5001(b)(3) and 71.702(c):
Measurement of Airborne Fiber
Concentration
D. Discussion of Asbestos Take-Home
Contamination
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E. Section 71.701(c) and (d): Sampling;
General Requirements
VIII. Regulatory Analyses
A. Executive Order (E.O.) 12866
B. Feasibility
C. Alternatives Considered
D. Regulatory Flexibility Analysis (RFA)
and Small Business Regulatory
Enforcement Fairness Act (SBREFA)
E. Other Regulatory Considerations
IX. Copy of the OSHA Reference Method
(ORM)
X. References Cited in the Preamble
B. Dates and Locations for Public
Hearings
We will hold two public hearings. If
you wish to make a statement for the
record, please submit your request to us
at least 5 days prior to the hearing dates
by one of the methods listed in the
ADDRESSES section above. The hearings
will begin at 9 a.m. with an opening
statement from MSHA, followed by
statements or presentations from the
public, and end after the last speaker (in
any event not later than 5 p.m.) on the
following dates at the locations
indicated:
October 18, 2005, Denver Federal
Center, Sixth and Kipling, Second
Street, Building 25, Denver, Colorado
80225, Phone: 303–231–5412.
October 20, 2005, Mine Safety and
Health Administration, 1100 Wilson
Boulevard, Room 2539, Arlington,
Virginia 22209, Phone: 202–693–
9457.
We will hear scheduled speakers first,
in the order that they sign in; however,
you do not have to make a written
request to speak. To the extent time is
available, we will hear from persons
making same-day requests. The
presiding official may exercise
discretion to ensure the orderly progress
of the hearing by limiting the time
allocated to each speaker for their
presentation.
The hearings will be conducted in an
informal manner. Although formal rules
of evidence or cross examination will
not apply, the hearing panel may ask
questions of speakers and a verbatim
transcript of the proceedings will be
prepared and made a part of the
rulemaking record. We also will post the
transcript on MSHA’s Home Page at
https://www.msha.gov, on the Asbestos
Single Source Page.
Speakers and other attendees may
present information to the MSHA panel
for inclusion in the rulemaking record.
We will accept written comments and
data for the record from any interested
party, including those not presenting
oral statements. The post-hearing
comment period will close on
November 21, 2005, 30 days after the
last public hearing.
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C. Executive Summary
In March of 2001, the U.S.
Department of Labor, Office of the
Inspector General (OIG) published a
report evaluating MSHA’s enforcement
actions at the vermiculite mine in Libby,
Montana. The widespread asbestos
contamination at this mine and
surrounding community, together with
the prevalence of asbestos-related
illnesses and fatalities among persons
living in this community, attracted press
and public attention, which prompted
the OIG investigation and report. The
OIG found that MSHA had conducted
regular inspections and personal
exposure sampling at the mine, as
required by the Federal Mine Safety and
Health Act of 1977 (Mine Act). The OIG
report stated, ‘‘We do not believe that
more inspections or sampling would
have prevented the current situation in
Libby.’’ The OIG made five
recommendations to MSHA; two of
which we implemented immediately.
The remaining recommendations are
listed below:
• Lower the existing permissible
exposure limit (PEL) for asbestos to a
more protective level.
• Use transmission electron
microscopy (TEM) instead of phase
contrast microscopy (PCM) in the initial
analysis of fiber samples that may
contain asbestos.
• Implement special safety
requirements to address take-home
contamination.
In response to the OIG’s
recommendations, MSHA published an
advance notice of proposed rulemaking
(ANPRM) on March 29, 2002 (67 FR
15134). MSHA also held seven public
meetings around the country to seek
input and obtain public comment on
how best to protect miners from
exposure to asbestos.
Following review of all public
comments and testimony taken at the
public meetings, and relying on OSHA’s
1986 asbestos risk assessment, we
determined that it is appropriate to
propose reducing the PELs for asbestos
and clarify criteria for asbestos sample
analysis. To enhance the health and
safety of miners, we are proposing to
lower the existing 8-hour, timeweighted average (TWA) PEL of 2.0 f/cc
to 0.1 f/cc, and to lower the short-term
limit from 10.0 f/cc over a minimum
sampling time of 15 minutes to an
excursion limit PEL of 1.0 f/cc over a
minimum sampling time of 30 minutes.
To clarify the criteria for the analytical
method in our existing standards, we
are proposing to incorporate a reference
to Appendix A of OSHA’s asbestos
standard (29 CFR 1910.1001). Appendix
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A specifies basic elements of a PCM
method for analyzing airborne asbestos
samples. It includes the same analytical
elements specified in our existing
standards and allows MSHA’s use of
other methods that meet the statistical
equivalency criteria in OSHA’s asbestos
standard.
The scope of this proposed rule,
therefore, is limited to lowering the
permissible exposure limits, an issue
raised by the OIG; incorporating
Appendix A of OSHA’s asbestos
standard for the analysis of our asbestos
samples; and making several
nonsubstantive conforming
amendments to our existing rule
language. After considering several
regulatory approaches to prevent takehome contamination, we determined
that non-regulatory measures could
adequately address this potential
hazard.
D. Abbreviations and Acronyms
As a quick reference, we list below
some of the abbreviations used in the
preamble.
29 CFR Title 29, Code of Federal
Regulations
30 CFR Title 30, Code of Federal
Regulations
AFL–CIO American Federation of Labor
and Congress of Industrial Organizations
ATSDR Agency for Toxic Substances and
Disease Registry, Centers for Disease
Control and Prevention, U.S. Department
of Health and Human Services
Bureau former Bureau of Mines, U.S.
Department of the Interior
cc cubic centimeter (cm3) = milliliter (mL)
EPA U.S. Environmental Protection Agency
f fiber(s)
FR Federal Register
Lpm liter(s) per minute
MESA former Mining Enforcement and
Safety Administration, U.S. Department of
the Interior (predecessor to MSHA)
MSHA Mine Safety and Health
Administration, U.S. Department of Labor
mm millimeter = 1 thousandth of a meter
(0.001 m)
mL milliliter = 1 thousandth of a liter
(0.001 L) = cubic centimeter
NIOSH National Institute for Occupational
Safety and Health, Centers for Disease
Control and Prevention, U.S. Department
of Health and Human Services
OIG Office of the Inspector General, U.S.
Department of Labor
OSHA Occupational Safety and Health
Administration, U.S. Department of Labor
PCM phase contrast microscopy
PEL permissible exposure limit
PLM polarized light microscopy
STEL short-term exposure limit
SWA shift-weighted average concentration
TEM transmission electron microscopy
TWA time-weighted average concentration
µm micron = micrometer = 1 millionth of a
meter (0.000001 m)
USGS U.S. Geological Survey, U.S.
Department of the Interior
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II. Background
A. Scope of Proposed Rule
This proposed rule would apply to
metal and nonmetal mines, surface coal
mines, and the surface areas of
underground coal mines. Because
asbestos from any source poses a health
hazard to miners if they inhale it, the
proposed rule would cover all miners
exposed to asbestos whether naturally
occurring or contained in building
materials, in other manufactured
products at the mine, or in mine waste
or tailings.
The National Institute for
Occupational Safety and Health
(NIOSH) and other research
organizations and scientists (see Table
VI–5) have observed the occurrence of
cancers and asbestosis among metal and
nonmetal miners involved in the mining
and milling of commodities that contain
asbestos. For this reason, our primary
focus at metal and nonmetal mines is on
asbestos in pockets or veins of mined
commodities. Historically, there has
been no evidence of coal miners
encountering naturally occurring
asbestos.1 The more likely exposure to
asbestos in coal mining would occur
from introduced asbestos-containing
products, such as asbestos-containing
building materials (ACBM) in surface
structures.
In 2000, the OIG investigated MSHA’s
activities at the vermiculite mine in
Libby, Montana. The OIG’s conclusions
and recommendations, discussed later,
are consistent with MSHA’s
observations and concerns that—
• Miners are exposed to asbestos at
mining operations where the ore body
or surrounding rock contains asbestos;
• Miners are potentially exposed to
airborne asbestos at mine facilities with
installed asbestos-containing material
when it is disturbed during
maintenance, construction, renovation,
or demolition activities; and
• Family and community are
potentially exposed if miners take
asbestos home on their person, clothes,
or equipment, or in their vehicle.
We developed this proposed rule
based on our experience with asbestos,
our assessment of the health risks, the
OIG’s recommendations, and public
comments on MSHA’s ANPRM
addressing the OIG’s recommendations.
We received numerous comments in
response to the ANPRM and at the
1 Personal communication with Professor Kot
Unrug, Department of Mining Engineering,
University of Kentucky, on November 14, 2003; and
with Syd S. Peng, Chairman, Department of Mining
Engineering, College of Engineering and Mineral
Resources, West Virginia University, the week of
October 24, 2003.
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public meetings, some of which
suggested or supported additional
requirements beyond those addressed
by the OIG. We believe that the
comments to the ANPRM do not justify
an expansion of the scope, at this time,
beyond the recommendations
specifically raised in the OIG report.
On the contrary, we believe that our
data support a narrowed scope in that
we specifically are not proposing two of
the OIG’s recommendations, i.e., routine
use of TEM for the initial analysis of
exposure samples and promulgation of
standards to prevent take-home
contamination. We are proposing,
however, to lower our permissible
exposure limits.
We have decided not to propose to
change our existing definition of
asbestos in this rulemaking. There are
several reasons for this.
First, this rulemaking is limited in
scope. We believe that a 20-fold
lowering of the exposure limits, as we
have proposed, together with our
enhanced measures to educate the
mining community about the asbestos
hazard in mining, would increase
protection for miners and help avoid the
future development of situations such as
that in Libby, Montana.
Second, interest in the definition of
asbestos extends to numerous agencies
in Federal, state, and local governments.
Our existing definition is consistent
with several Federal agencies’
regulatory provisions, including
OSHA’s. Changing the definition would
require considerable interagency
consultation and coordination;
additional scientific evaluation; and an
unnecessary delay in providing miners
access to the benefits of this proposed
rule.
Third, we believe another Libby-like
mining operation would not exist today
because such a business arguably would
not be economically viable. If a mine’s
ore contained significant amounts of
asbestos-like minerals, there is a strong
likelihood of potential liability risks,
both from customers and workers, and
the possibility that the mine’s product
would be commercially unmarketable.
Such market forces are likely to compel
mining companies of all sizes to sample
the ore for the presence of hazardous
fibrous minerals before purchasing or
developing a mine site. In our view,
these commercial reasons make it
unlikely that a new Libby-like mining
condition would arise in the future.
B. Where Asbestos Is Found at Mining
Operations
Asbestos is no longer mined as a
commodity in the United States. Even
so, veins, pockets, or intrusions of
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asbestos have been found in other ores
in specific geographic regions, primarily
in metamorphic or igneous rock.2
Although less common, it is not
impossible to find asbestos in
sedimentary rock, soil, and air from the
weathering or abrasion of other
asbestos-bearing rock.3 The areas where
asbestos may be located can be
determined from an understanding of
the mineralogy of asbestos and the
geology required for its formation. In
some cases, visual inspection can detect
the presence of asbestos. MSHA
experience indicates that miners may
encounter asbestos during the mining of
a number of mineral commodities,4
such as talc, limestone and dolomite,
vermiculite, wollastonite, banded
ironstone and taconite, lizardite, and
antigorite. Not all mines of a specific
commodity contain asbestos in the ore,
however, and the mines that do have
asbestos in the ore may encounter it
rarely.
Asbestos also is contained in building
materials and other manufactured
products found at mines. Contrary to the
common public perception, asbestos is
not banned in the United States.5 The
U.S. Geological Survey (USGS)
estimates that about 13,000 metric tons
(29 million pounds) of asbestos were
used in product manufacturing in the
United States during 2001.6 In addition
to domestic manufacturing, the United
States continues to import products that
contain asbestos. Asbestos may be used
for a number of purposes at a mine
including insulation; reinforcement of
cements; reinforcement of floor, wall,
and building tile; and automotive clutch
and brake linings.7 If asbestos is present
at the mine, miners in the vicinity are
potentially at increased risk from
asbestos exposure, regardless of whether
or not they are actually working with
asbestos.
C. Asbestos Minerals
To understand the scientific
literature, information about asbestos,
and the issues raised in the public
comments, it is important to understand
the terminology used to describe
minerals, asbestos, and fibers. This
section briefly reviews a number of key
terms and concepts associated with
asbestos that we use in discussing this
proposed rule.
(Bank), 1980.
1995.
4 Roggli et al., 2002; Selden et al., 2001; Amandus
et al., Part I, 1987; Amandus et al., Part III, 1987;
Amandus and Wheeler, Part II, 1987.
5 GETF Report, pp. 12–13, 2003.
6 USGS (Virta), p. 28, 2003.
7 Lemen, 2003; Paustenbach et al., 2003.
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3 USGS,
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1. Mineralogical Classification and
Mineral Names
The terminology used to refer to how
minerals form and how they are named
is complex. A mineral’s physical
properties, composition, crystalline
structure, and morphology determine its
classification. Asbestos minerals belong
to either the serpentine (sheet silicate)
or the amphibole (double-chain silicate)
family of minerals. Most of the
difficulties in classifying minerals as
asbestos have involved the amphiboles.
The formation of a particular mineral
(chemical composition) or habit
(morphology, crystalline structure)
occurs gradually and may be
incomplete, producing intermediate
minerals that are difficult to classify. In
the past, there have been several
different systems used to classify and
name minerals that, in some instances,
led to inconsistent terminology and
classification. Currently, there is no
single, universally accepted system for
naming minerals.
Asbestos is a commercial term used to
describe certain naturally occurring,
hydrated silicate minerals. Several
Federal agencies have regulations that
focus on these minerals. The properties
of asbestos that give it commercial value
include low electrical and thermal
conductivity, chemical and crystalline
stability and durability, high tensile
strength, flexibility, and friability. Much
of the existing health risk data for
asbestos uses commercial mineral
terminology. Meeker et al. (2003)
recognized the confusion associated
with asbestos nomenclature, stating—
Within much of the existing asbestos
literature, mineral names are not applied in
a uniform manner and are not all consistent
with presently accepted mineralogical
nomenclature and definitions.
a. Variations in Mineral Morphology.
There are many types of crystal
habits, such as fibrous, acicular (slender
and needle-like), massive (irregular
form), and columnar (stout and columnlike). The morphology of a mineral may
not fit a precise definition. For example,
Meeker et al. (2003) state that the Libby
amphiboles contain ‘‘a complete range
of morphologies from prismatic crystals
to asbestiform fibers.’’ Some minerals
crystallize in more than one habit. Some
minerals, which can form in different
habits, have a different name for each
habit; others do not.8 For example,
crocidolite is the name for the
asbestiform habit and riebeckite is the
name for the same mineral in its
nonasbestiform habit. Tremolite and
actinolite do not have different names
8 Reger
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and Morgan, 1990; ATSDR, p. 138, 2001.
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depending on habit; therefore, to
distinguish between the different habits,
the descriptive term ‘‘asbestiform’’ or
‘‘asbestos’’ is added to the mineral’s
name. If the identifying, descriptive
term is not used with the mineral name,
misunderstandings or mistakes may
occur.
b. Variations in Mineral Composition.
Atoms similar in size and valence
state can replace each other within a
mineral’s crystal lattice, resulting in the
formation of a different mineral in the
same mineral series. This process is
gradual and can occur to a different
extent in the same mineral depending
on the geological conditions during its
formation. For example, tremolite
contains magnesium, but no (or little)
iron, and holds an end member position
in its mineral series. Iron atoms can
replace the magnesium atoms in
tremolite and the resulting mineral may
then be called actinolite. The quantity of
iron needed before the mineral is called
actinolite varies depending on the
mineral classification scheme used.
Another example is winchite, which is
an intermediate member of the
tremolite-glaucophane series, as well as
an end member in its own sodic-calcic
series.9 Given the chemical similarity
within the series, winchite
[(NaCa)Mg4(Al,Fe3∂)Si8O 22(OH)2] often
has been reported as tremolite
[Ca2Mg5Si8O22(OH)2].
A specific rock formation may contain
a continuum of minerals from one end
member of a series to the other end
member, creating a solid solution of
intermediate minerals. These
intermediate minerals are sometimes
given names, while at other times they
are not. Often, when the exact chemical
composition is not determined or
determined to be a number of different
intermediate minerals, the mineral is
named by one or more of its end
members, such as tremolite-actinolite or
cummingtonite-grunerite. The fibrous
amphiboles in the Libby ore body, for
example, contain both end members and
several intermediate minerals. Meeker et
al. (2003) state that—
The variability of compositions on the
micrometer scale can produce single fibrous
particles that can have different amphibole
names at different points of the particle.
A mineral may also undergo
transition to a different mineral series.
Kelse and Thompson (1989), Ross
(1978), and USGS (Virta, 2002) have
commented on the chemical transition
of anthophyllite to talc. Stewart and Lee
(1992) stated that fibrous talc might
contain intermediate particles not easily
9 Leake
differentiated from asbestos. In the
context of systems for naming and
classifying fibrous amphiboles, Meeker
et al. (2003) state that the regulatory
literature often gives nominal
compositions for a mineral without
specifying chemical boundaries.
2. Differentiating Asbestiform and
Nonasbestiform Habit
In the asbestiform habit, mineral
crystals grow forming long, thread-like
fibers. When pressure is applied to an
asbestos fiber, it bends much like a wire,
rather than breaks. Fibers can separate
into ‘‘fibrils’’ of a smaller diameter
(often less than 0.5 µm). This effect is
referred to as ‘‘polyfilamentous,’’ and
should be viewed as one of the most
important characteristics of asbestos.
Appendix A of the Environmental
Protection Agency’s (EPA’s) Method for
the Determination of Asbestos in Bulk
Building Materials 10 defines
asbestiform as follows:
* * * a mineral that is like asbestos, i.e.,
crystallized with the habit [morphology] of
asbestos. Some asbestiform minerals may
lack the properties which make asbestos
commercially valuable, such as long fiber
length and high tensile strength. With the
light microscope, the asbestiform habit is
generally recognized by the following
characteristics:
Mean aspect [length to width] ratios
ranging from 20:1 to 100:1 or higher for fibers
longer than 5 micrometers. Aspect ratios
should be determined for fibers, not bundles.
Very thin fibrils, usually less than 0.5
micrometers in width, and two or more of the
following:
—Parallel fibers occurring in bundles,
—Fiber bundles displaying splayed ends,
—Matted masses of individual fibers, and/or
—Fibers showing curvature.
In the nonasbestiform habit, mineral
crystals do not grow in long thin fibers.
They grow in a more massive habit. For
example, a long thin crystal may not be
polyfilamentous nor possess high
tensile strength and flexibility, but may
break rather than bend. When pressure
is applied, the nonasbestiform crystals
fracture easily into prismatic particles,
which are called cleavage fragments
because they result from the particle’s
breaking or cleavage, rather than the
crystal’s formation or growth. Some
particles are acicular (needle shaped),
and stair-step cleavage along the edges
of some particles is common.
Cleavage fragments may be formed
when nonfibrous amphibole minerals
are crushed, as may occur in mining and
milling operations. Cleavage fragments
are not asbestiform and do not fall
within our definition of asbestos. For
some minerals, distinguishing between
et al., p. 222, 1997.
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asbestiform fibers and cleavage
fragments in certain size ranges is
difficult or impossible when only a
small number of structures are available
for review, as opposed to a
representative population. Meeker et al.
(2003) states that it is often difficult or
impossible to determine differences
between acicular cleavage fragments
and asbestiform mineral fibers on an
individual fiber basis. A determination
as to whether a mineral is asbestiform
or not must be made, where possible, by
applying existing analytical methods.
Although we have received comments
regarding the hazards associated with
cleavage fragments, we do not intend to
modify our existing definition of
asbestos with this rulemaking.
III. History of Asbestos Regulation
When Federal agencies responsible
for occupational safety and health began
to regulate occupational exposure to
asbestos, studies had already
established that the inhalation of
asbestos fibers was a major cause of
disability and death among exposed
workers. The intent of these first
asbestos rules was to protect workers
from developing asbestosis.11
A. MSHA’s Asbestos Standards for
Mining
1967–1969. In 1967, under the former
Bureau of Mines, predecessor to the
Mining Enforcement and Safety
Administration (MESA) and then
MSHA, the standard for asbestos
exposure in mining was an 8-hour, timeweighted average (TWA) PEL of 5 mppcf
(million particles per cubic foot of air).
In 1969, the Bureau promulgated a 2
mppcf and 12 f/mL (fibers per milliliter)
standard.
1974–1976. In 1974, MESA
promulgated a 5 f/mL standard for
asbestos exposure in metal and
nonmetal mines (39 FR 24316). In 1976,
MESA promulgated a 2 f/cc standard (41
FR 10223) for asbestos exposure in
surface areas of coal mines. We retained
these standards under the authority of
the Federal Mine Safety and Health Act
of 1977.
1978. In November 1978, we
promulgated a 2 f/mL standard for
asbestos exposure in metal and
nonmetal mines (43 FR 54064). Since
then, we have made only
nonsubstantive changes to our asbestos
standards, e.g., renumbering the section
of the standard in 30 CFR.
MSHA’s existing standards for
asbestos at metal and nonmetal mines at
30 CFR 56/57.5001 state,
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(b) The 8-hour time-weighted average
airborne concentration of asbestos dust to
which employees are exposed shall not
exceed 2 fibers per milliliter greater than 5
microns in length, as determined by the
membrane filter method at 400–450
magnification (4 millimeter objective) phase
contrast illumination. No employees shall be
exposed at any time to airborne
concentrations of asbestos fibers in excess of
10 fibers longer than 5 micrometers, per
milliliter of air, as determined by the
membrane filter method over a minimum
sampling time of 15 minutes. ‘‘Asbestos’’ is
a generic term for a number of hydrated
silicates that, when crushed or processed,
separate into flexible fibers made up of
fibrils. Although there are many asbestos
minerals, the term ‘‘asbestos’’ as used herein
is limited to the following minerals:
chrysotile, Amosite, crocidolite, anthophylite
asbestos, tremolite asbestos, and actinolite
asbestos.
The existing standard for asbestos at
surface coal mines and surface work
areas of underground coal mines at 30
CFR 71.702 states,
(a) The 8-hour average airborne
concentration of asbestos dust to which
miners are exposed shall not exceed two
fibers per cubic centimeter of air. Exposure
to a concentration greater than two fibers per
cubic centimeter of air, but not to exceed 10
fibers per cubic centimeter of air, may be
permitted for a total of 1 hour each 8-hour
day. As used in this subpart, the term
asbestos means chrysotile, amosite,
crocidolite, anthophylite asbestos, tremolite
asbestos, and actinolite asbestos but does not
include nonfibrous or nonasbestiform
minerals.
(b) The determination of fiber
concentration shall be made by counting all
fibers longer than 5 micrometers in length
and with a length-to-width ratio of at least 3
to 1 in at least 20 randomly selected fields
using phase contrast microscopy at 400–450
magnification.
1989. In 1989, as part of our Air
Quality rulemaking, we proposed to
lower the full-shift exposure limit for
asbestos from 2 f/cc to 0.2 f/cc to
address the excessive risk quantified in
the Occupational Safety and Health
Administration’s (OSHA’s) 1986
asbestos rule (54 FR 35760). The Air
Quality rulemaking, however, was
withdrawn on September 26, 2002 (67
FR 60611). MSHA has not reinstated the
Air Quality rulemaking at this time.
B. OSHA’s Asbestos Standards for
General Industry and Construction
1971–1972. The initial promulgation
of OSHA standards on May 29, 1971 (36
FR 10466) included a 12 f/cc PEL for
asbestos. Then, on December 7, 1971, in
response to a petition by the Industrial
Union Department of the AFL-CIO,
OSHA issued an emergency temporary
standard (ETS) on asbestos that
established an 8-hour, TWA PEL of 5 f/
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cc and a peak exposure level (ceiling
limit) of 10 f/cc. In June 1972, OSHA
promulgated these limits in a final rule.
1975. In October 1975, OSHA
proposed to revise its asbestos standard
by reducing the 8-hour, TWA PEL to 0.5
f/cc with a ceiling limit of 5 f/cc for 15
minutes (40 FR 47652). OSHA stated
that sufficient medical and scientific
evidence had accumulated to warrant
the designation of asbestos as a human
carcinogen and that advances in
monitoring and protective technology
made re-examination of the standard
appropriate. The final rule, however,
reduced OSHA’s 8-hour, TWA asbestos
PEL to 2 f/cc due to feasibility concerns.
This limit remained in effect until
OSHA revised it in 1986.
1983–1986. On November 4, 1983,
OSHA published another emergency
temporary standard (ETS) for asbestos
(48 FR 51086), which would have
lowered the 8-hour, TWA PEL from 2 f/
cc to 0.5 f/cc. The Asbestos Information
Association challenged the ETS in the
U.S. Court of Appeals for the 5th
Circuit. On March 7, 1984, ruling on
Asbestos Information Association/North
America v. OSHA (727 F.2d 415, 1984),
the Court invalidated the ETS.
Subsequent to this decision, OSHA
published a proposed rule (49 FR
14116) that, together with the ETS,
proposed two alternatives for lowering
the 8-hour, TWA PEL: 0.2 f/cc and 0.5
f/cc.
On June 17, 1986, OSHA issued
comprehensive asbestos standards (51
FR 22612) governing occupational
exposure to asbestos in general industry
workplaces (29 CFR 1910.1001),
construction workplaces (29 CFR
1926.1101), and shipyards (29 CFR
1915.1001). The separate standards
shared the same asbestos PEL and most
ancillary requirements. These standards
reduced OSHA’s 8-hour, TWA PEL to
0.2 f/cc from the previous 2 f/cc limit.
OSHA added specific provisions in the
construction standard to cover unique
hazards relating to asbestos abatement
and demolition jobs.
Although tremolite, actinolite, and
anthophyllite exist in different forms,
OSHA determined that all forms of
these minerals would continue to be
regulated. Following promulgation of
the rule, several parties requested an
administrative stay of the standard
claiming that OSHA improperly
included nonasbestiform minerals. A
temporary stay was granted and OSHA
initiated rulemaking to remove the
nonasbestiform types of these minerals
from the scope of the asbestos
standards.
1988. Several major participants in
OSHA’s rulemaking challenged various
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provisions of the 1986 revised
standards. In Building Construction
Trades Division (BCTD), AFL-CIO v.
Brock (838 F.2d 1258, 1988), the U.S.
Court of Appeals for the District of
Columbia upheld most of the challenged
provisions, but remanded certain issues
to OSHA for reconsideration. In partial
response, on September 14, 1988, OSHA
promulgated an excursion limit of 1 f/
cc for asbestos as measured over a 30minute sampling period (53 FR 35610).
1992. OSHA’s 1986 standards had
applied to occupational exposure to
nonasbestiform actinolite, tremolite, and
anthophylite. On June 8, 1992, OSHA
deleted the nonasbestiform types of
these minerals from the scope of its
asbestos standards. In evaluating the
record, OSHA found (57 FR 24310–
24311) insufficient evidence that
nonasbestiform actinolite, tremolite, and
anthophyllite present ‘‘a risk similar in
kind and extent’’ to their asbestiform
counterparts. Additionally, the evidence
did not show that OSHA’s removal of
the nonasbestiform types of these three
minerals from its asbestos standard
‘‘will pose a significant risk to exposed
employees.’’
1994. On August 10, 1994, OSHA
published a final rule (59 FR 40964) that
lowered its 8-hour, TWA PEL for
asbestos to 0.1 f/cc and retained the 1
f/cc excursion limit as measured over 30
minutes.
C. Other Federal Agencies Regulating
Asbestos
Because the health hazards of
exposure to asbestos are well
recognized, it is highly regulated. OSHA
and MSHA have the primary authority
to regulate occupational exposures to
asbestos. EPA regulates asbestos
exposure of state and local government
workers in those states that do not have
an OSHA State Plan covering them. A
number of other Federal agencies,
primarily EPA and the Consumer
Product Safety Commission (CPSC),
regulate non-occupational asbestos
exposures. For example, CPSC regulates
asbestos in consumer products, such as
patching compounds, under the Federal
Hazardous Substances Act.
EPA regulates asbestos in air and
materials. EPA’s activities have focused
on environmental issues and the public
health by reducing emissions of
hazardous gases and dusts from large
industrial sources, such as taconite ore
processing,12 and the cleanup of
contaminated waste sites. EPA also
regulates asbestos in schools. The
mining and processing of vermiculite in
Libby, Montana, resulted in the spread
12 EPA
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of asbestos to numerous homes, schools,
and businesses throughout the town. In
November 1999, EPA responded to a
request to study the environmental
contamination in the town of Libby and
widespread illnesses and death among
its residents. In October 2002, EPA
designated the area as a Superfund site.
D. Other Asbestos-Related Activities
There have been increasing numbers
of studies on asbestos and its hazards
over the past 40 years. These efforts
encompass government, industry, and
academia on a local, national, and
international scale. Government
agencies and scientific groups in the
United States, such as the National
Institute for Occupational Safety and
Health (NIOSH), the Agency for Toxic
Substances and Disease Registry
(ATSDR), the American Conference of
Governmental Industrial Hygienists
(ACGIH), and the National Toxicology
Program (NTP), have addressed issues
involving carcinogens, such as asbestos.
Organizations from other countries,
such as the United Kingdom (Health
and Safety Executive) and Germany
(Deutche Forschungsgemeinschaft), also
have addressed occupational exposure
to asbestos and other carcinogens.
Similarly, the International Agency for
Research on Cancer (IARC) has
published a monograph on asbestos that
summarizes evidence of its
carcinogenicity.13
1. Interagency Asbestos Work Group
(IAWG)
OSHA’s and EPA’s overlapping
responsibilities and common interest in
addressing asbestos hazards led to the
formation of the IAWG. Participating
Federal agencies include EPA, OSHA,
CPSC, MSHA, NIOSH, ATSDR, USGS,
and the National Institute of Standards
and Technology (NIST). This work
group of government agencies facilitates
the sharing of information and
coordination of activities, including
regulatory activities, environmental
assessment, technical assistance,
consumer protection, and developments
in environmental analysis of
contaminants. The IAWG also seeks to
harmonize the policies, procedures, and
enforcement activities of the
participating agencies, thus minimizing
or eliminating potential conflicts for the
regulated community. For example, the
IAWG is currently discussing the
Federal definition of asbestos.
13 IARC,
1987.
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2. National Institute for Occupational
Safety and Health (NIOSH)
The Workers’ Family Protection Act
of 1992 (29 U.S.C. 671A) directed
NIOSH to study contamination of
workers’ homes by hazardous
substances, including asbestos,
transported from the workplace.
ATSDR, EPA, OSHA, MSHA, the U.S.
Department of Energy (DOE), and the
Centers for Disease Control and
Prevention (CDC) assisted NIOSH in
conducting the study. For this proposed
rule we focused on the asbestos-related
results of these studies.
NIOSH (1995) published its study
results in a Report to Congress on
Workers’ Home Contamination Study
Conducted under the Workers’ Family
Protection Act. This report summarizes
incidents of home contamination,
including the health consequences,
sources, and levels of contamination.
The study documents cases of asbestos
reaching workers’ homes in 36 states in
the United States and in 28 other
countries. These cases covered a wide
variety of materials, industries, and
occupations. The means by which
hazardous substances reached workers’
homes and families included taking the
substance home on the worker’s body,
clothing, tools, and equipment; cottage
industries (i.e., work performed on
home property); and family visits to the
workplace. In an effort to reach
employers and workers, NIOSH (1997)
published its recommendations in
Protect Your Family: Reduce
Contamination at Home. This pamphlet
summarizes the NIOSH study and
provides recommendations to prevent
this contamination.
3. Agency for Toxic Substances and
Disease Registry (ATSDR)
The Superfund Amendments and
Reauthorization Act of 1986 (SARA)
directed ATSDR to prepare toxicological
profiles for hazardous substances most
commonly found at specific waste sites.
ATSDR and EPA determined which
hazardous substances pose the most
significant potential threat to human
health and targeted them for study.
Asbestos is one of these targeted
substances. ATSDR published one of the
most current toxicological profiles for
asbestos in September 2001, which was
an update of an earlier asbestos profile.
In October 2002, ATSDR sponsored a
meeting of expert panelists who
presented their evaluation of state-ofthe-art research concerning the
relationship between fiber length and
the toxicity of asbestos and synthetic
vitreous fibers. We have reviewed the
evidence and arguments presented in
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the updated asbestos toxicological
profile and the meeting proceedings and
have discussed this information in this
preamble, where appropriate.
E. U.S. Department of Labor, Office of
the Inspector General (OIG)
In November 1999, a Seattle
newspaper published a series of articles
on the unusually high incidence of
asbestos-related illnesses and fatalities
among individuals who had lived in
Libby, Montana. There was extensive
national media attention surrounding
the widespread environmental
contamination and asbestos-related
deaths in Libby. Dust and construction
materials from the nearby vermiculite
mine were the alleged cause. This mine
had produced about 90 percent of the
world’s supply of vermiculite from 1924
until 1992.
Because MSHA had jurisdiction over
the mine for two decades before it
closed, the OIG investigated MSHA’s
enforcement actions at the mine. The
OIG confirmed that the processing of
vermiculite at the mine exposed miners
to asbestos. The miners then,
inadvertently, had carried the asbestos
home on their clothes and in their
personal vehicles.14 In doing this, the
miners continued to expose themselves
and family members.
1. OIG Report on MSHA’s Handling of
Inspections at the W.R. Grace &
Company Mine in Libby, Montana
The OIG published its findings and
recommendations in a report dated
March 22, 2001. The OIG found that
MSHA had appropriately conducted
regular inspections and personal
exposure sampling at the Libby mine
and that there were no samples
exceeding the 2.0 f/cc PEL for the 10
years prior to the mine closing in 1992.
The OIG concluded, ‘‘We do not believe
that more inspections or sampling
would have prevented the current
situation in Libby.’’ The OIG stated its
belief that there is a need for MSHA to
lower its asbestos PEL.
In its report, the OIG supported the
development and implementation of
control measures for asbestos and
vermiculite mining and milling. They
also made recommendations for
improving our effectiveness in
controlling this hazard. This proposed
rule addresses our responses to several
of the OIG’s recommendations.
2. MSHA’s Libby, Montana Experience
W.R. Grace acquired the vermiculite
mine in Libby, Montana, in 1963. At
that time, the amphibole in the
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vermiculite was called tremolite, soda
tremolite, soda-rich tremolite, or
richterite, and researchers had already
linked the mine dust to respiratory
disease.15 The suggested exposure limit
for asbestos in mining was much higher
than current limits. The federal standard
for asbestos in mining dropped from 5
mppcf (about 30 f/mL) in 1967 to 2 f/
mL in 1978. When MESA (predecessor
agency to MSHA) began inspecting the
operation, the exposure limit for
asbestos was 5 f/mL.
The mine operator, Federal mine
inspectors, and representatives of the
U.S. Public Health Service [part of the
Centers for Disease Control and
Prevention (CDC)] routinely sampled for
asbestos at the Libby mine, starting
before the mine switched to wet
processing in 1974, and continued
sampling periodically until the mine
closed in 1992. MSHA sampling at the
Libby mine found no exposures
exceeding the 5.0 f/cc asbestos PEL from
1975 through 1978, and only a few over
the 2.0 f/cc asbestos PEL from 1979
through 1986. Almost all the samples
would have exceeded the 0.1 f/cc
proposed limit. Miners’ exposures
continued to decrease and more recent
sampling since 1986 found few
exposures exceeding the OSHA PEL of
0.1 f/cc.
The results from our personal
exposure sampling at the Libby mine
included many of the fibrous
amphiboles present. In addition, the
results from TEM analysis of the air
samples characterized the mineralogy of
the airborne fibers as tremolite and did
not distinguish between the species of
amphiboles. Further characterization of
the amphibole minerals using Scanning
Electron Microscopy/Energy Dispersive
X-ray Spectroscopy technology shows
proportions of about 84 percent
winchite, 11 percent richterite, and 6
percent tremolite.16
As early as 1980, MSHA had
requested that NIOSH investigate health
problems at all vermiculite operations,
including the mine and mill in Libby,
Montana. NIOSH published its study
results in a series of three papers
(Amandus et al., Part I, 1987; Amandus
and Wheeler, Part II, 1987; Amandus et
al., Part III, 1987). The study of
Amandus et al. (Part I, 1987) along with
that of McDonald et al. (1986) found
that, historically, the highest exposures
to fibers at the Libby operation had
occurred in the mill and that exposures
had decreased between the 1960’s and
15 McDonald et al., 1986; Meeker et al., 2003;
Peipins et al., 2003.
16 Meeker et al., 2003
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1970’s. McDonald et al. (1986)
reported—
In 1974, the old dry and wet mills were
closed and the ore was processed in a new
mill built nearby which operated on an
entirely wet basis in which separation was
made by vibrating screens, Humphrey
separators, and flotation.
McDonald et al. (1986) and Amandus
and Wheeler (Part II, 1987) also showed
that, even at reduced exposure levels,
there was still increased risk of lung
cancer among the Libby miners and
millers.
3. MSHA’s Efforts To Minimize
Asbestos Take-Home Contamination
‘‘Take-home’’ contamination is
contamination of workers’ homes or
vehicles by hazardous substances
transported from the workplace. As
discussed previously in this preamble,
the widespread asbestos-related disease
among the residents of Libby, Montana,
was attributed, in part, to take-home
contamination from the vermiculite
mining and milling operation in that
town. The OIG report on MSHA’s
activities recommended that we
promulgate special safety standards
similar to those in our 1989 proposed
Air Quality rule (54 FR 35760) to
address take-home contamination.
In our 1989 Air Quality proposed
rule, we had proposed that miners wear
protective clothing and other personal
protective equipment before entering
areas containing asbestos. Our Air
Quality proposed rule also would have
required miners to remove their
protective clothing and store them in
adequate containers to be disposed of or
decontaminated by the mine operator.
These proposed requirements were
similar to those in OSHA’s asbestos
standard and to NIOSH’s
recommendations.
In March 2000, shortly after the series
of articles on asbestos-related illnesses
and deaths in Libby, Montana, we
issued a Program Information Bulletin
(PIB No. P00–3) about asbestos. The PIB
served to remind the mining industry of
the potential health hazards from
exposure to airborne asbestos fibers and
to raise awareness about potential
asbestos exposure for miners, their
families, and their communities. At that
time, we also issued a Health Hazard
Information Card (No. 21) about
asbestos for distribution to miners to
raise their awareness about the health
hazards related to asbestos exposure.
The PIB included information about
asbestos, its carcinogenic and other
significant health effects, how miners
could be exposed, where asbestos
occurs naturally on mining property,
and what types of commercial products
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may contain asbestos. It included
recommendations to help mine
operators reduce miners’ exposures, to
prevent or minimize take-home
contamination, and for the selection and
use of respiratory protection. The PIB
also urged mine operators to minimize
exposures, to improve controls, and to
train miners, listing specific training
topics as essential for miners potentially
exposed to asbestos.
During this same period, 2000 to
2003, we conducted an asbestos
awareness campaign and increased
asbestos sampling. Section VII.D of this
preamble contains an additional
discussion of measures to prevent
asbestos ‘‘take-home’’ contamination.
We have decided not to pursue a
regulatory approach to minimizing
asbestos ‘‘take-home’’ contamination.
Based on the existing levels of asbestos
exposures in the mining industry,
comments on our 2002 ANPRM, and
testimony at the subsequent public
meetings, we have determined that a
non-regulatory approach would be
effective in minimizing asbestos takehome contamination from mining
operations.
4. Training Inspectors to Recognize and
Sample for Asbestos
The OIG recommended that we
increase MSHA inspectors’ skills for
providing asbestos compliance
assistance to mine operators. In
response, we developed a half-day
multimedia training program that
includes the following:
• A PowerPoint-based training
presentation that examines MSHA’s
procedures for air and bulk asbestos
sampling.
• An updated ‘‘Chapter 8—Asbestos
Fibers’’ from the Metal and Nonmetal
Health Inspection and Procedures
Handbook that serves as a text for the
training sessions.
• A ‘‘hands-on’’ segment that allows
the inspectors to examine asbestos and
asbestiform rock samples and the
equipment used for bulk sampling, and
that provides the inspectors instruction
and practice in assembling and
calibrating asbestos fiber air sampling
apparatus.
We gave this asbestos training to
journeymen inspectors from March 2002
through April 2003, and added it to the
training program for entry-level
inspectors.
IV. Health Effects of Asbestos Exposure
The health hazards from exposure to
asbestos were discussed extensively in
the preamble to OSHA’s 1983 final rule
(51 FR 22615). Subsequently,
researchers have confirmed and
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increased our knowledge of these
hazards. Exposures in occupational and
environmental settings are generally due
to inhalation, although some asbestos
may be absorbed through ingestion.
While the part of the body most likely
affected (target organ) is the lung,
adverse health effects may extend to the
linings of the chest, abdominal, and
pelvic cavities, and the gastrointestinal
tract. The damage following chronic
exposure to asbestos is cumulative and
irreversible. Workplace exposures to
asbestos may be chronic, continuing for
many years. The symptoms of asbestosrelated adverse health effects may not
become evident for 20 or more years
after first exposure (latency period).
A. Summary of Asbestos Health
Hazards
This section presents an overview of
human health effects from exposure to
asbestos. We are proposing to use
OSHA’s 1986 risk assessment to
estimate the risk from asbestos
exposures in mining. OSHA’s risk
assessment has withstood legal scrutiny
and the more recent studies discussed
later in this preamble support it. MSHA
has placed OSHA’s risk assessment in
the asbestos rulemaking record. It can
also be found at https://www.osha.gov.
Studies first identified health
problems associated with occupational
exposure to asbestos in the early 20th
century among workers involved in the
manufacturing or use of asbestoscontaining products.17 Early studies
identified the inhalation of asbestos as
the cause of asbestosis, a slowly
progressive disease that produces lung
scarring and loss of lung elasticity.
Studies also found that asbestos caused
lung and several other types of cancer.
For example, mesotheliomas, rare
cancers of the lining of the chest or
abdominal cavities, are almost
exclusively attributable to asbestos
exposure. Once diagnosed, they are
rapidly fatal. Asbestos-related diseases
have long latency periods, commonly
not producing symptoms for 20 to 30
years following initial exposure.
In the late 1960’s, scientists correlated
phase contrast microscopy fiber
counting methods with the earlier types
of dust measurements. This procedure
provided a means to estimate earlier
workers’ asbestos exposures and
enabled researchers to develop a doseresponse relationship with the
occurrence of disease. The British
Occupational Hygiene Society
reported 18 that a worker exposed to 100
fiber-years per cubic centimeter (e.g., 50
years at 2 f/cc, 25 years at 4 f/cc, 10
years at 10 f/cc) would have a 1 percent
risk of developing early signs of
asbestosis. The correlation of exposure
levels with the disease experience of
populations of exposed workers
provided a basis for setting an
occupational exposure limit for asbestos
measured by the concentration of the
fibers in air.
As mentioned previously, the
hazardous effects from exposure to
asbestos are now well known. For this
reason, our discussion in this section
will focus on the results of the more
recent studies and literature reviews,
those published since the publication of
OSHA’s risk assessment, and those
involving miners. One such review by
Tweedale (2002) stated,
Asbestos has become the leading cause of
occupational related cancer death, and the
second most fatal manufactured carcinogen
(after tobacco). In the public’s mind, asbestos
has been a hazard since the 1960s and 1970s.
However, the knowledge that the material
was a mortal health hazard dates back at least
a century, and its carcinogenic properties
have been appreciated for more than 50
years.
Greenberg (2003) also published a
recent review of the biological effects of
asbestos and provided a historical
perspective similar to that of Tweedale.
The three most commonly described
adverse health effects associated with
asbestos exposure are lung cancer,
mesotheliomas, and pulmonary fibrosis
(i.e., asbestosis). OSHA, in its 1986
asbestos rule, reviewed each of these
diseases and provided details on the
studies demonstrating the relationship
between asbestos exposure and the
clinical evidence of disease. In 2001, the
ATSDR published an updated
Toxicological Profile for Asbestos that
also included an extensive discussion of
these three diseases. A search of peerreviewed scientific literature using
databases, such as Gateway, PubMed,
and ToxLine, accessed through the
National Library of Medicine (NLM),
yielded nearly 900 new references on
asbestos from January 2000 to October
2003. Many of these recent articles 19
continue to demonstrate and support
findings of asbestos-induced lung
cancer, mesotheliomas, and asbestosis,
consistent with the conclusions of
OSHA and ATSDR. Thus, in the
scientific community, there is
compelling evidence of the adverse
health effects of asbestos exposure. This
has led some researchers and
stakeholders to recommend a
worldwide ban of asbestos.20
B. Factors Affecting the Occurrence and
Severity of Disease
The toxicity of asbestos, and the
subsequent occurrence of disease, is
related to its concentration (C) in the
mine air and to the duration (T) of the
miner’s exposure. Other variables, such
as the fiber’s characteristics or the
effectiveness of the miner’s lung
clearance mechanisms, also affect
disease severity.
1. Concentration (C)
Currently, the concentration (C) of
asbestos is expressed as the number of
fibers per cubic centimeter (f/cc). Some
studies have also reported asbestos
concentrations in the number of fibers
per milliliter (f/mL), which is an
equivalent concentration to f/cc.
MSHA’s existing PELs for asbestos are
expressed in f/mL for metal and
nonmetal mines and as f/cc for coal
mines. To improve consistency and
avoid confusion, we express the
concentration of airborne fibers as f/cc
in this proposed rule, for both coal and
metal and nonmetal mines.
Older scientific literature (i.e., 1960’s
and 1970’s) reported exposure
concentrations as million particles per
cubic foot (mppcf) and applied a
conversion factor to convert mppcf to
f/cc. OSHA (51 FR 22617) used a factor
of 1.4 when performing these
conversions. More recently, Hodgson
and Darnton (2000) recommended the
use of a factor of 3. In our evaluation of
the scientific literature, we did not
critically evaluate the impact of these
and other conversion factors. We note
this difference here for completeness.
Because we are relying on OSHA’s risk
assessment, we are using OSHA’s
conversion factor
2. Time (T)
Epidemiological and toxicological
studies generally report time (T) in years
(yr). The product of exposure
concentration and exposure duration
(i.e., C × T) is referred to as ‘‘fiberyears’’.21 When developing exposureresponse relationships for asbestosinduced health effects, researchers
typically use ‘‘fiber-years’’ to indicate
the level of workplace exposure.
Finkelstein 22 noted, however, that this
product of exposure concentration times
duration of exposure (C × T) assumes an
equal weighting of each variable (C, T).
20 Maltoni,
17 GETF
Report, p. 38, 2003; OSHA (40 FR 47654),
1975.
18 Lane et al., 1968; OSHA (40 FR 47654), 1975.
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2001; Bolton et al., 2002; Manning et al.,
2002; Nicholson, 2001; Osinubi et al., 2000; Roach
et al., 2002.
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1999.
2001; Fischer et al., 2002; Liddell,
2001; Pohlabeln et al., 2002.
22 Finkelstein, 1995; ATSDR, p. 42, 2001.
21 ATSDR,
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3. Fiber Characteristics
Baron (2001) reviewed techniques for
the measurement of fibers and stated,
‘‘* * * fiber dose, fiber dimension, and
fiber durability are the three primary
factors in determining fiber [asbestos]
toxicity * * *’’. Manning et al. (2002)
also noted the important roles of biopersistence (i.e., durability), physical
properties, and chemical properties in
defining the ‘‘toxicity, pathogenicity,
and carcinogenicity’’ of asbestos. Roach
et al. (2002) stated that—
Physical properties, such as length,
diameter, length-to-width (aspect ratio), and
texture, and chemical properties are believed
to be determinants of fiber distribution [in
the body] and disease severity.
Many other investigators 23 also have
concluded that the dimensions of
asbestos fibers are biologically
important.
OSHA and MSHA currently specify
that analysts count those fibers that are
over 5.0 micrometers (µm) in length
with a length to diameter aspect ratio of
at least 3:1. Several recent
publications 24 support this aspect ratio,
although larger aspect ratios such as 5:1
or 20:1 have been proposed.25 There is
some evidence that longer, thinner
asbestos fibers (e.g., greater than 20 µm
long and less than 1 µm in diameter) are
more potent carcinogens than shorter
fibers. Suzuki and Yuen (2002),
however, concluded that ‘‘Short, thin
asbestos fibers should be included in
the list of fiber types contributing to the
induction of human malignant
mesotheliomas * * * ’’. More recently,
Dodson et al. (2003) concluded that all
lengths of asbestos fibers induce
pathological responses and that
researchers should exercise caution
when excluding a population of inhaled
fibers based on their length.
We have determined that researchers
have found neither a reliable method for
predicting the contribution of fiber
length to the development of disease,
nor evidence establishing the exact
relationship between them. There is
suggestive evidence that the dimensions
of asbestos fibers may vary with
different diseases. A continuum may
exist in which shorter, wider fibers
produce one disease, such as asbestosis,
and longer, thinner fibers produce
another, such as mesotheliomas.26 The
scientific community continues to
publish new data that will enable
regulatory agencies, such as MSHA, to
23 ATSDR, 2001; Osinubi et al., 2000; Peacock et
al., 2000; Langer et al., 1979.
24 ATSDR, 2001; Osinubi et al., 2000.
25 Wylie et al., 1985.
26 ATSDR, pp. 39–41, 2001; Mossman, pp. 47–50,
2003.
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better understand the relationship
between fiber dimensions, durability,
inhaled dose, and other important
factors that determine the health risks of
exposure not only to asbestos, but also
to other fibers.
4. Differences in Fiber Potency
The theory that the differences among
fibers have an effect on their ability to
produce adverse effects on human
health has received a great deal of
attention. Hodgson and Darnton (2000),
Browne (2001), and Liddell (2001)
discuss a fiber gradient hypothesis,
which is now termed the amphibole
hypothesis. This hypothesis proposes
that the amphiboles (e.g., crocidolite,
amosite) are more hazardous than the
serpentine, chrysotile. ATSDR (p. 39,
2001) recently stated that—
Available evidence indicates that all
asbestos fiber types are fibrogenic, although
there may be some differences in relative
potency among fiber types.
In its 1986 asbestos rule, OSHA (51
FR 22628) stated that—
* * * epidemiological and animal
evidence, taken together, fail to establish a
definitive risk differential for the various
types of asbestos fiber. Accordingly, OSHA
has * * * recognized that all types of
asbestos fiber have the same fibrogenic and
carcinogenic potential * * *
In its comments on MSHA’s asbestos
ANPRM, NIOSH stated that—
(3) experimental animal carcinogenicity
studies with various minerals have provided
strong evidence that the carcinogenic
potential depends on the ‘‘particle’’ length
and diameter. The consistency in
tumorigenic responses observed for various
mineral particles of the same size provides
reasonable evidence that neither composition
nor origin of the particle is a critical factor
in carcinogenic potential; * * *
This issue remains unresolved.
Although possible differences in fiber
potency are beyond the scope of this
proposed rule, we will continue to
monitor results of research in this area.
5. Lung Clearance Mechanisms
Inhaled asbestos may deposit
throughout the respiratory tract,
depending on the aerodynamic behavior
of the fibers.27 As noted by Baron
(2001), ‘‘* * * fiber aerodynamic
behavior indicates that small diameter
fibers are likely to reach into and
deposit in the airways of the lungs.’’
Clearing the lungs of deposited asbestos
occurs by several mechanisms. In the
mid-airways (i.e., bronchial region),
small hair-like cells sweep the mucus
containing asbestos toward the throat, at
which time it is swallowed or
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1966.
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expectorated. The swallowing of mucus
through this clearance mechanism can
result in inhaled asbestos reaching the
gastrointestinal tract.
In the air sacs deep within the lungs
(the alveolar region), pulmonary
macrophages engulf foreign matter,
including asbestos fibers. The
macrophages attempt to remove these
fibers by transporting them to the
circulatory or lymphatic system. Some
studies have shown that groups of
macrophages try to engulf longer
fibers.28 When asbestos fibers are not
cleared, they may initiate inflammation
of the cells lining the alveoli. This
inflammation leads to more serious
physical effects in the lungs. OSHA
(1986), ATSDR (2001), and several
recent papers 29 discuss these
mechanisms for the pulmonary
clearance of asbestos.
C. Specific Human Health Effects
1. Lung Cancer
Lung cancer is a chronic, irreversible,
and often fatal disease of the lungs.
Epidemiological studies confirm, and
toxicological studies support, the
carcinogenicity of asbestos. (See section
IV.D. below.) The form of lung cancer
seen most often in asbestos-exposed
individuals is bronchial carcinoma.
Some of the risk factors for lung cancer
include airborne asbestos concentration,
duration of exposure, fiber dimensions,
the age of the individual at the time of
first exposure, and the number of years
since the first exposure.30 Another
major risk factor is the smoking of
tobacco products. Numerous studies
have concluded that there are
synergistic effects between asbestos and
tobacco smoke in the development of
lung cancer.31 This is especially
relevant to miners as NIOSH (May 2003)
estimates that 33 percent of miners
currently smoke.
The mechanism through which
asbestos causes lung cancer is under
study. Recent papers by Manning et al.
(2002), Xu et al. (2002), and Osinubi et
al. (2000) describe a scheme of cell
signaling and inflammation with the
release of reactive oxygen species and
reactive nitrogen species.
The latency period for asbestosrelated lung cancer is generally 20–30
years, although some cases have been
reported within 10 years, and some up
to 50 years, after initial asbestos
exposure.32 Lung cancer caused by
28 Warheit,
p. 308, 1993.
2001; Osinubi et al., 2000.
30 Yano et al., 2001; ATSDR, 2001.
31 Bolton et al., 2002; Manning et al., 2002;
OSHA, 1986.
32 Roach et al., 2002.
29 Baron,
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asbestos can progress even in the
absence of continued exposure. Thus, in
all of its stages, lung cancer constitutes
a material impairment of human health
or functional capacity.
In the preamble to its 1986 asbestos
standard (51 FR 22615), OSHA stated,
‘‘Of all the diseases caused by asbestos,
lung cancer constitutes the greatest
health risk for American asbestos
workers.’’ OSHA (51 FR 22615–22616)
also stated, ‘‘* * * Asbestos exposure
acts synergistically with cigarette
smoking to multiply the risk of
developing lung cancer.’’ MSHA
believes that the essential points of this
statement remain true today.
Steenland et al. (2003) estimated that
there were about 150,000 lung cancer
deaths in 1997 in the United States, and
that 6.3 to 13 percent (i.e., 9,700 to
19,900) of these lung cancer deaths were
occupationally-related. Steenland et al.
(1996) also had estimated that, in the
mid-1990’s, there were about 5,400
asbestos-related lung cancer deaths per
year. NIOSH (May 2003) identified over
10,000 lung cancer deaths in the United
States during 1999 based on only 20
Census Industry Codes (CIC). This sum
was computed from ‘‘selected states,’’
not the entire United States. NIOSH
(May 2003) also identified 300 lung
cancer deaths among coal miners from
15 selected states.
2. Mesotheliomas
Mesotheliomas are malignant tumors
that are rapidly fatal. They involve thin
membranes that line the chest (the
pleura) and that surround internal
organs (the peritoneum) following
asbestos exposure.33 Mesotheliomas
begin with a localized mass and, like
other malignant tumors, they can spread
(metastasize) to other parts of the
body.34 It does not appear that smoking
is a major risk factor in the development
of mesotheliomas.35
As in cases of lung cancer and
asbestosis, mesotheliomas also have a
latency period, varying from 15 to over
40 years.36 Orenstein et al. (2000)
reported an even wider range for the
latency, from a minimum of 5 years to
a maximum of 72 years. In cases
involving the pleura, patients often
complain of chest pain, breathing
difficulties on exertion, weakness, and
fatigue. Other early symptoms of this
disease may also include weight loss
and cough. As the disease progresses,
there is increased restriction of the chest
wall and highly abnormal respiration,
33 ATSDR,
2001.
et al., 2002.
35 Bolton et al., 2002.
36 Suzuki and Yuen, 2002.
34 Roach
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often characterized by a rapid and
shallow breathing pattern.
Mesotheliomas are rapidly progressive
even in the absence of continued
asbestos exposure. Mesotheliomas have
a poor prognosis in most patients; death
typically occurs within a year or so of
diagnosis.37 Thus, like lung cancer,
mesotheliomas materially impair human
health and functional capacity.
As noted by ATSDR (2001), OSHA
(1986), and many others,38
mesotheliomas are extremely rare
tumors, particularly in non-asbestos
exposed individuals. OSHA (1986) has
stated, ‘‘* * * In some asbestosexposed occupational groups, 10
percent to 18 percent of deaths have
been attributable to malignant
mesotheliomas * * * ’’. NIOSH (May
2003) reported that there were about
2,500 deaths due to malignant
mesotheliomas in the United States in
1999. Steenland et al. (2003) estimated
that there were about 2,100 deaths in
the United States from mesotheliomas
in 1997, and that, in males, 85–90
percent of these deaths from
mesotheliomas were due to
occupational asbestos exposure. These
tumors were generally the underlying
(primary) cause of death, and not just a
contributing cause of death. NIOSH
found that most mesothelioma deaths
were included with the categories of
‘‘all other industries’’ (56 percent) or
‘‘all other occupations’’ (57 percent). For
those death certificates that included a
Census Industry Code (CIC), the most
frequently recorded was ‘‘construction.’’
The 2003 NIOSH publication, WorkRelated Lung Disease Surveillance
Report 2002 (WoRLD), did not provide
specific data on mesotheliomas among
miners.
One commenter expressed concern
that the use of perchlorate in explosives
might be a co-factor for increasing the
incidence or shortening the latency
period for mesothelioma among miners.
In investigating this comment, we found
that perchlorate can be a component in
explosives 39 and that perchlorate may
cause or contribute to thyroid disease.40
We found no studies linking perchlorate
to mesotheliomas. The California State
Department of Toxic Substances Control
states that perchlorate ‘‘* * * has not
been linked to cancer in humans
* * *’’.41
37 Bolton et al., 2002; Roach et al., 2002; Osinubi
et al., 2000; West, 2003.
38 Bolton et al., 2002; Britton, 2002; Carbone et
al., 2002; Manning et al., 2002; Orenstein et al.,
2000; Roach et al., 2002; Suzuki and Yuen, 2002.
39 EPA, 2002.
40 ATSDR, 1998.
41 https://www.dtsc.ca.gov/ToxicQuestions/
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3. Asbestosis
Asbestosis is a chronic and
irreversible disease caused by the
deposition and accumulation of asbestos
in the lungs. It can lead to substantial
injury and may cause death from the
build up of bands of scar tissue and a
loss of lung elasticity (i.e., pulmonary
fibrosis).42 It is not a tumor. Following
exposure to asbestos, chronic
inflammation may occur that leads to
the multiplication of collagen-producing
cells in the lung and the accumulation
of thick collagen bundles in essential
lung tissues.43 These structural changes
result in a hardening or stiffening of the
lungs. Physicians who specialize in
diseases of the lung also classify
asbestosis as a restrictive lung disease
due to this loss of elasticity.
In asbestosis, the lungs are unable to
properly expand and contract during the
breathing cycle and, thus, lung volumes,
airflows, and respiratory frequencies are
likely to be abnormal.44 Two common
symptoms of this disease are cough and
breathing difficulties. Patients with
asbestosis may also complain of a
general feeling of discomfort, weakness,
and fatigue. Breathing difficulties,
weakness, and fatigue are often more
severe with work or exercise. As the
disease progresses, patients begin to
experience symptoms even while
resting and are likely to become
permanently disabled.45 Patients with
severe asbestosis also may experience
heart or circulation problems, such as
heart enlargement. Like lung cancer and
mesotheliomas, asbestosis may be
progressive even in the absence of
continued asbestos exposure. Thus,
asbestosis, even in its earliest stages,
constitutes a material impairment of
human health and functional capacity.
NIOSH (May 2003) reported that there
were about 1,200 asbestosis-related
deaths in the United States in 1999. Of
these, asbestosis was the underlying
cause in about a third of these deaths
(400) and a contributing cause in the
others (800). Steenland et al. (2003)
estimated that there were about 400
deaths from asbestosis in 1997, and that
100 percent of these asbestosis-deaths
were due to occupational exposure. As
shown by NIOSH (May 2003), the
number of deaths related to asbestosis
increased over ten-fold between 1968
and 1999. NIOSH also reported that
these figures likely reflect improved
diagnostic tools and the long latency
period for evidence of disease that
follows asbestos exposure.
42 ATSDR,
2001.
et al., 2000.
44 West, 2000; West, 2003.
45 OSHA, 1986.
43 Osinubi
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The death certificates for most
individuals who died from asbestosis
lacked the Census Industry Code (CIC)
and the Census Occupation Code (COC).
Most asbestosis deaths were classified
under ‘‘all other industries’’ (45 percent)
and ‘‘all other occupations’’ (57
percent). For those death certificates
that included a CIC and a COC, the most
frequently recorded industry and
occupation were ‘‘construction’’ (CIC =
060) and ‘‘plumbers, pipefitters, and
steamfitters’’ (COC = 585), respectively.
There were no specific data on
asbestosis-related deaths among miners
in the NIOSH WoRLD publication (May
2003).
4. Other Cancers
OSHA, in its 1986 rule, reviewed
epidemiologic studies of asbestos
workers with cancer of the colon,
rectum, kidney, larynx (voice box),
throat, or stomach. Of these studies,
researchers placed the greatest emphasis
on those involving gastrointestinal
cancers. OSHA concluded, ‘‘* * * the
risk of incurring cancers at these [other]
sites is not as great as the increased risk
of lung cancer * * *’’. Thus, OSHA
included lung and gastrointestinal
cancers, and not these other cancer
sites, in its 1986 risk assessment. MSHA
believes that the statement remains true
today, based on studies cited by ATSDR
(2001) and by recent papers on kidney
cancer,46 laryngeal cancer,47
lymphomas,48 and pancreatic cancer.49
We have not attempted to quantify the
risks of these other cancers, which are
small in comparison to lung cancer and
mesotheliomas.
5. Reversible Airways Obstruction
(RAO)
Under normal physiological
conditions, oxygen and other inhaled
chemical substances pass through a
branching network of airways that
become narrower, shorter, and more
numerous as they penetrate deeper into
the lung.50 The diameter of each airway
has an important effect on its airflow. A
reduction in airway diameter occurs
temporarily on exposure to some
chemical substances and permanently
in some diseases. These reductions lead
to temporary or permanent airflow
limitations. A temporary reduction of
airway diameter and the resulting
difficulties in breathing have also been
called broncho-constriction, acute
airways constriction or obstruction, or
46 McLaughlin
and Lipworth, 2000; Sali and
Boffetta, 2000.
47 Browne and Gee, 2000.
48 Becker et al., 2001.
49 Ojajarvi et al., 2000.
50 West, 2000.
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reversible airways obstruction (RAO).
Such constriction or obstruction
typically involves airways in the mid to
lower respiratory tract.
Several recent studies have examined
respiratory health and respiratory
symptoms of asbestos-exposed
workers.51 Wang et al. (2001) reported
permanent changes in airway diameters
and, thus, permanent airflow limitations
in diseases such as asbestosis or chronic
obstructive pulmonary disease (COPD).
Although patients can recover from
RAO, they do not recover from
asbestosis or COPD, which are typically
progressive, leading to increasingly
severe illness and premature death.
Delpierre et al. (2002) reported that
RAO in asbestos workers was
independent of x-ray signs of
pulmonary or pleural fibrosis, as well as
a worker’s smoking status. The longterm implications of RAO are unknown
at this time. Delpierre et al., however,
encouraged physicians to screen
asbestos workers for RAO. Lung
function tests may be useful in the early
diagnosis of asbestos-disease, especially
if RAO precedes the development of
irreversible pulmonary disease, such as
asbestosis.
6. Other Nonmalignant Pleural Disease
and Pleural Plaques
The pleura is the membrane lining the
chest cavity. Pleural plaques are
discrete, elevated areas of nearly
transparent fibrous tissue (scar tissue)
and are composed of thick collagen
bundles. Pleural thickening and pleural
plaques are biologic markers reflecting
previous asbestos exposure.52 They
appear opaque on radiographic images
and white to yellow in microscopic
sections.53 The American Thoracic
Society (ATS, 2004) has described the
criteria for diagnosis of non-malignant
asbestos-related pleural disease and
pleural plaques.
Pleural plaques are the most common
manifestation of asbestos exposure.54
Only rarely do they occur in persons
who have no history or evidence of
asbestos exposure. Pleural thickening
and pleural plaques may occur in
individuals exposed to asbestos in both
occupational settings, such as miners,
and non-occupational settings, such as
family members. For example, the
prevalence of pleural plaques ranges
from 0.53 percent to 8 percent in
environmentally exposed populations,
51 Delpierre et al., 2002; Eagen et al., 2002; Selden
et al., 2001.
52 ATSDR, 2001; Manning et al., 2002.
53 Bolton et al., 2002; Manning et al., 2002; Roach
et al., 2002; Peacock et al., 2000; ATSDR, 2001.
54 Cotran et al., p. 732–734, 1999; Peacock et al.,
2000.
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such as the residents of Libby, Montana;
3 percent to 14 percent in dockyard
workers; and up to 58 percent among
insulation workers.
Pleural plaques may develop within
10–20 years after an initial asbestos
exposure 55 and slowly progress in size
and amount of calcification,
independent of any further exposure.
There is no evidence that pleural
plaques undergo malignant
degeneration into mesothelioma.56
Pleural thickening and pleural plaques,
however, may impair lung function and
may precede chronic lung disease that
develops in some individuals.57 Rudd
(1996), for example, reported that the
incidence of lung cancer in patients
with pleural plaques is higher than that
of other patients. These plaques are also
part of the clinical picture of asbestosis.
7. Asbestos Bodies
Some asbestos-exposed individuals
may expel asbestos fibers from the lungs
with a coating of iron and protein.
These collections of coated fibers, found
in sputum or broncho-alveolar lavage
(BAL) fluid, are called asbestos bodies
or ferruginous bodies.58 Like pleural
thickening and pleural plaques, these
bodies indicate prior asbestos exposure.
D. Support From Toxicological Studies
of Human Health Effects of Asbestos
Exposure
Many studies are available that clearly
demonstrate the toxicity of asbestos
(e.g., carcinogenicity, genotoxicity,
pneumotoxicity) and confirm observed
human responses.59 Studies conducted
in baboons, mice, monkeys, and rats
have all demonstrated that asbestos
fibers are carcinogenic.60 OSHA’s risk
assessment, however, did not rely on
data from in vivo or in vitro
toxicological studies to determine the
human health effects from exposure to
asbestos. In the preamble to its 1986
asbestos rule (51 FR 22632), OSHA
stated—
OSHA chose not [emphasis added] to use
animal studies to predict quantitative
estimates of risk from asbestos exposure
because of the many high quality human
studies available that were conducted in
actual workplace situations * * * OSHA has
supplemented the human data with results
from the animal studies when evaluating the
55 Bolton
et al., 2002; OSHA, 1986.
et al., 2000; West, 2003.
57 Schwartz et al., 1994.
58 ATSDR, 2001; Peacock et al., 2000.
56 Peacock
59 OSHA,
1986; ATSDR, 2001.
et al., 1986; Davis and Jones, 1988; Davis
et al., (in IARC) 1980; Davis et al., 1980; Donaldson
et al., 1988; Goldstein and Coetzee, 1990; McGavran
et al., 1989; Reeves, et al., 1974; Wagner et al., 1974,
1980; Webster et al., 1993.
60 Davis
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health information and determining the
significance of risk.
A. Determining Asbestos Exposures in
Mining
1. Asbestos-Contaminated Ore Case
Study: Wollastonite
Because we are relying on OSHA’s 1986
asbestos risk assessment for this
proposed rule, we do not use the
toxicological studies for a quantitative
assessment of risk, but as supportive of
the causative relationship between
asbestos exposure and observed human
health effects.
Toxicological studies are providing
important information on possible
mechanism(s) through which asbestos
causes disease. The ATSDR
Toxicological Profile for Asbestos
(updated 2001) contains a more detailed
discussion on this topic and describes
several mechanisms of action for
asbestos. These include—
• Its direct interaction with cellular
macromolecules,
• Its recruitment of pulmonary
macrophages that produce reactive
oxygen and nitrogen species, and
• Its initiation of other cellular
responses (e.g., inflammation).
To evaluate asbestos exposures in
mines, MSHA collects personal
exposure air samples using a personal
sampling pump and a filter-cassette
assembly, composed of a 50-mm
electrically conductive extension cowl
and a 25-mm diameter mixed cellulose
ester (MCE) filter. Following standard
sampling procedures, we also submit
blank filters for analysis. Analysts use
the blanks to correct the sampling
results for background fiber counts due
to variations in the manufacturing and
analysis of the filter.
Since 2001, we have used contract
laboratories to analyze our asbestos
samples by PCM. The contract
laboratories report analytical results as
the fiber concentration (f/cc) for each
filter analyzed. Then, to evaluate a
miner’s full-shift exposure, MSHA
calculates an 8-hour time-weighted
average concentration from a
consecutive series of individual filters.
Several factors complicate the
evaluation of personal exposure levels
in mining. Non-asbestos particles
collected on the filter can hide the
asbestos fibers (overloading) and, as
discussed earlier (see section II.C.2),
mining samples may also contain
intermediate fibers that are difficult to
classify. (See section II.B in this
preamble.)
Wollastonite is a monocalcium
silicate found in the United States,
Mexico, and Finland. It occurs as
prismatic crystals that can split into
massive-to-acicular (needle-like)
fragments when processed, and is used
mainly in ceramics.64
A consumer recently sent a sample of
the final bulk product from a
wollastonite mine to a commercial
laboratory for analysis. When the
analysis indicated the presence of
asbestos contamination, the consumer
informed the mine operator. The mine
operator contacted MSHA and informed
us of this finding after their contract
laboratory confirmed the presence of
tremolite in product samples. MSHA
then conducted industrial hygiene
sampling in the mill and the pit to
verify and track the source of the
tremolite. We found that concentrations
in the mill exceeded 2.0 f/cc as
measured by PCM. Although asbestos
averaged only about 1.3 percent of the
total fibers, over half of the exposures in
the mill exceeded 0.1 f/cc of asbestos
(the OSHA 8-hour, TWA PEL). Miners’
exposures in the pit were much lower
and further analyses indicated that few
of these samples contained asbestos.
The mine instituted an aggressive
cleanup and control policy in the
interest of the company and their
miners’ health. This wollastonite facility
provides and launders uniforms for the
millers, provides physical examinations
to miners and their families, and uses
other administrative controls to limit
take-home contamination. In addition to
conducting personal asbestos sampling,
MSHA assisted mine management
through the following compliance
assistance activities:
• Assistance in developing cleanup
and monitoring procedures.
• Discussion of hazards of asbestos
exposure with miners and the operator.
• Identification of accredited
laboratories familiar with mining
samples to perform asbestos analyses.
• Assistance in implementation of a
respiratory protection program.
• Instruction in recognition and
avoidance of asbestos. MSHA and the
mine operator worked together in
recognizing the problem, evaluating the
hazard, and determining ways to control
exposures. This case study demonstrates
successful cooperation to protect the
health of miners.
V. Characterization and Assessment of
Exposures in Mining
Asbestos minerals are widespread in
the environment.61 The use of asbestoscontaminated crushed rocks in roads,
asbestos in insulation and other
building materials, and the release of
asbestos from brakes on vehicles
contributes to its presence in the
environment. Occupational asbestos
exposures can be much higher than the
asbestos levels the public typically
encounters.
Miners may be exposed to asbestos in
nature, as well as in commercial
products. Mining, milling, maintenance,
or other activities at the mine may result
in the release or re-suspension of
asbestos into the air.62 In some geologic
formations, asbestos may be in isolated
pockets or distributed throughout the
ore. Mining operations, such as blasting,
cutting, crushing, grinding, or simply
disturbing the ore or surrounding earth
may cause the asbestos to become
airborne. Milling operations may
transform bulk ore containing
asbestiform minerals into respirable
fibers. Similarly, other activities
conducted at mine sites, such as
removing asbestos-containing materials
during renovation or demolition of
buildings and equipment repair work,63
may contribute to a miner’s asbestos
exposure.
61 ATSDR,
62 MSHA
2001.
(Bank), 1980; Amandus et al., Part I,
1987.
63 EPA, 1986, 1993, April 2003.
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B. Exposures From Naturally Occurring
Asbestos
Mining and milling of asbestoscontaminated ore can release fibers into
the ambient air. Beginning in January
2000, we initiated a focused effort to
determine the extent of asbestos
exposure among miners. We chose 124
metal and nonmetal mines for sampling
based on the following:
• Geological information linking a
higher probability for asbestos
contamination with certain types of ores
or commodities.
• Historical records identifying
locations of potential problem mines.
• Complaints from miners reporting
asbestos on mine property.
Asbestos tends to accumulate during
the milling process, which is often in
enclosed buildings. The use of
equipment and machinery or other
activities in these locations may resuspend the asbestos-containing dust
from workplace surfaces into the air. For
this reason, we generally find higher
airborne concentrations in mills than
among mobile equipment operators or
in ambient environments, such as pits.
The following example supports this
finding.
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64 Warheit,
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2. Methods of Reducing or Avoiding
Miners’ Exposures to Naturally
Occurring Asbestos
Some mine operators mining other
commodities that are likely to contain
asbestos, such as vermiculite, have
stated that they are making an effort to
avoid deposits and seams likely to
contain substantial quantities of
asbestos. They use knowledge of the
geology of the area, visual inspections of
the working face, and sample analysis to
avoid encountering asbestos deposits,
thus preventing asbestos contamination
of their product.65 In addition, some
mine operators have voluntarily
adopted the OSHA 8-hour, TWA PEL
(0.1 f/cc), thus reducing the potential for
asbestos-related illness among miners.
C. Exposures From Introduced
(Commercial) Asbestos
Asbestos is an important component
in some commercial products and may
be found as a contaminant in others.
Due to improved technology and
increased awareness, however,
substitutes for asbestos in products are
available for almost all uses, and
manufacturers have removed the
asbestos from many new products.66
Nevertheless, there are mines, including
coal mines, that have introduced
commercial asbestos-containing
products on their property. Some of
these introduced products may include
asbestos-containing building materials,
such as Transite board, used during
construction, rehabilitation, or
demolition projects. Other examples of
introduced commercial products that
may contain asbestos are brake linings
for mining equipment, insulation, joint
and packing compounds, and asbestos
welding blankets.
Occasionally, miners report incidents
of possible asbestos release through
MSHA’s Hazard Complaint Program.
Inspectors also report mines with
noticeably deteriorated asbestoscontaining building materials (ACBM).
We investigate these reported situations
and take appropriate action. The
following example describes an incident
in which miners unsafely removed
asbestos at a mining operation.
1. Introduced Asbestos Case Study:
Potash
In June 2003, eight miners removed
siding on three transfer conveyors
originally installed in 1962 at a potash
mine in Utah. The siding was weathered
and deteriorated to the point of being
friable (crumbling). The type of siding
was a commercial product named
65 GETF
66 GETF
Report, pp. 17–18, 2003.
Report, pp. 12 and 15, 2003.
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Galbestos, which contains 7 percent
chrysotile asbestos, as indicated on the
Material Safety Data Sheet (MSDS).
Analysis of bulk samples of the debris
left behind by the removal of the siding
confirmed that it contained chrysotile
asbestos. When the miners removed it
without using special precautions, they
released asbestos into the air. It is
possible that these miners contaminated
themselves with asbestos and carried it
to their families and communities (i.e.,
take-home contamination).
MSHA became aware of this asbestosremoval work when one of the miners
made a hazard complaint to the MSHA
District Office. We conducted an
investigation and determined that the
company officials had known of the
potential asbestos hazard for at least 2
years. We found no asbestos in the
personal air samples collected after the
siding had been removed. Although we
did not issue citations for overexposure
to asbestos, we issued citations to the
company for failure to implement
special work procedures, failure to issue
appropriate personal protective
equipment, and failure to train the
affected miners for the task. The mine
operator took corrective action and we
terminated these citations.
2. Methods of Reducing or Avoiding
Miners’ Exposures to Introduced
(Commercial) Asbestos
Existing Federal and state standards
already address the removal of asbestoscontaining building materials (ACBM).
If the asbestos-containing material is
intact, it is preferable to leave it where
it is. If the asbestos-containing material
is worn or deteriorating, these standards
require the use of special precautions
(e.g., personal protective equipment,
training, decontamination) to prevent or
minimize exposure of workers and the
public and contamination of the
environment. We train our inspectors to
encourage mine operators to have worn
or deteriorating asbestos-containing
products removed by persons specially
trained to remove the asbestoscontaining material safely.
D. Sampling Data and Exposure
Calculations
After the national publicity
surrounding asbestos-related diseases
and death among the population of
Libby, Montana, MSHA closely
reviewed and updated its asbestosrelated health procedures and policies
for metal and nonmetal mines. We then
made sure these procedures and policies
were applied consistently across the
country. For example, we switched from
a 37-mm to a 25-mm filter cassette and
recommended appropriate flow rates
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and sampling times. We also allocated
additional resources to asbestos
sampling and analysis to verify and
evaluate the extent of asbestos
exposures in mining.
1. Explanation of Sampling Data and
Related Calculations
The time-weighted average (TWA)
concentration (f/cc) for individual filters
(n = 1, 2 * * *) is calculated by
dividing the number of fibers (f)
collected on the filter by the volume of
air (cc) drawn through the filter.
TWAsum is the total time-weighted
average concentration for all filters in
the series over the total sampling time.
The exposure limits in MSHA standards
are based on an 8-hour workday,
regardless of the actual length of the
shift. MSHA measures the miner’s
exposure for the entire time the miner
works. We then calculate a full-shift
airborne exposure concentration as if
the fibers had been collected over an 8hour shift. This allows us to compare
the miner’s exposure to the 8-hour
TWA, full-shift exposure limit. MSHA
calls this calculated 8-hour TWA a
‘‘shift-weighted average (SWA).’’
We calculate the TWAsum and SWA
exposure levels for each miner sampled
according to the following formulas,
respectively.
TWAsum = (TWA1t1 + TWA2t2 + * * *
+ TWAntn)/(t1 + t2 + * * * + tn)
SWA = (TWA1t1 + TWA2t2 + * * * +
TWAntn)/480 minutes
Where:
TWAn is the time-weighted average
concentration for filter ‘‘n’’.
tn is the duration sampled in minutes for
filter ‘‘n’’.
TWAntn is the time-weighted average
concentration for filter ‘‘n’’
multiplied by the duration sampled
for filter ‘‘n’’.
(t1 + t2 + * * * + tn) is the total time
sampled in minutes.
MSHA defines a ‘‘sample’’ as the
average 8-hour full-shift airborne
concentration that represents an
individual miner’s full-shift exposure.
The following information from our
database illustrates the sampling results
from these calculations. For one
mechanic at the potash mine in our
previous example, MSHA used a series
of three filter-cassettes to determine the
miner’s full-shift exposure. We sampled
a total of 577 minutes. The highest TWA
concentration for one filter-cassette in
this series was 4.100 f/cc as analyzed by
PCM. MSHA calculated the mechanic’s
full-shift exposure to report the fiber
concentration as if the mechanic had
received the full exposure in 8 hours
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(480 minutes). The mechanic’s shiftweighted average (SWA) was 1.982 f/cc.
2. Summary of MSHA’s Asbestos
Sampling and Analysis Results
To assess exposures and present our
TABLE V–1.—EXAMPLE OF PERSONAL asbestos sampling results to the public,
SAMPLING RESULTS
we compiled our asbestos sampling data
for the period January 1, 2000 through
Mechanic
PCM TWA
December 31, 2003. We formatted these
sampled 6/ Sampling time
fiber
data into four Excel workbooks, one for
17/2003 at
(minutes)
concentration
each year, and placed them, together
1.7 Lpm
(f/cc)
with additional explanatory
information, on our Asbestos Single
Filter-cassette 1 ...
230
4.100 Source Page at https://www.msha.gov/
asbestos/asbestos.htm.
Filter-casWe calculated an 8-hour full-shift
sette 2 ...
252
0.016
exposure for each miner sampled from
Filter-cassette 3 ...
95
0.045 the TWA of individual filters, typically
TWAsum rethree filters per shift. These data include
sult .........
577
1.649 the results of 703 full-shift personal
Sample
exposure samples, comprised of 2,184
(SWA)
filter-cassettes, and cover 163 industrial
result .....
480
1.982 hygiene sampling visits at 125 mines
(124 metal and nonmetal mines and one
coal mine), including some mines and
mills that are now closed. Because the
last remaining asbestos mine in the
United States (Joe 5 Pit in California)
closed in December 2002 and its
associated mill (King City) closed in
June 2003, we excluded those data in
our analysis.
Of the remaining 123 mines that
MSHA sampled during this 4-year
period, 18 mines could be potentially
impacted by the lowering of the fullshift permissible exposure limit to 0.1 f/
cc as measured by PCM. These 18 mines
have had at least one miner exposed to
airborne fiber concentrations exceeding
0.1 f/cc during this period. Two of the
18 mines (iron ore and wollastonite) had
personal asbestos exposures confirmed
by TEM exceeding 0.1 f/cc. Excluding
the 42 samples from the asbestos mine
and mill, 8 percent of the remaining 661
personal samples had 8-hour TWA, fullshift fiber concentrations greater than
the proposed 0.1 f/cc PEL, as measured
by PCM. Table V–2 below summarizes
these sampling results.
TABLE V–2.—PERSONAL EXPOSURE SAMPLES, ANALYZED BY PCM, AT CURRENTLY ACTIVE MINES 1 BY COMMODITY (1/
2000–12/2003)
Number of
mines
sampled
Commodity
Rock & quarry products 3 .........................................................................
Vermiculite ...............................................................................................
Wollastonite .............................................................................................
Iron (taconite) ...........................................................................................
Talc ..........................................................................................................
Boron .......................................................................................................
Other 4 ......................................................................................................
61
4
1
14
12
2
29
Total ..................................................................................................
Number (%) of
mines
>0.1 f/cc SWA
123
4 (7%)
3 (75%)
1 (100%)
5 (36%)
1 (8%)
1 (50%)
5 3 (10%)
6 18
(15%)
Number of
samples
Number (%) of
samples
>0.1 f/cc SWA 2
215
127
18
178
38
9
76
7 (3%)
5 (4%)
18 (100%)
17 (10%)
2 (5%)
4 (44%)
3 (4%)
661
56 (8%)
1 Excludes
data from a closed asbestos mine and mill.
2 MSHA uses TEM to confirm the presence of asbestos on samples showing exposures exceeding 0.1 f/cc.
3 Including stone, sand and gravel mines.
4 Coal, potash, gypsum, salt, cement, clay, lime, mica, metal ore NOS, olivine, shale, pumice, trona, perlite, and gold.
5 Coal, potash, and gypsum (Coal and potash personal exposures are due to commercially introduced fiber release episodes, i.e., not from a
mineral found at the mine).
6 TEM confirmed asbestos exposures exceeding 0.1 f/cc in two of the 18 mines.
MSHA is proposing to lower its 8hour TWA, full-shift PEL from 2.0 f/cc
to 0.1 f/cc to provide increased
protection for miners. As noted in
OSHA’s risk assessment for its 1986
asbestos rule, there is significant risk of
material impairment of health or
functional capacity even at this lower
PEL. MSHA compliance data indicate
that some miners’ asbestos exposures
have exceeded 0.1 f/cc. Available data
from death certificates in 24 states
confirm that there is asbestos-related
mortality among miners.67
67 NIOSH
World, p. E–1, 2003.
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VI. The Application of OSHA’s Risk
Assessment to Mining
We are applying OSHA’s risk
assessment to our exposure sampling
data on miners to estimate the risk from
asbestos exposure in mining. In
response to the ANPRM, the National
Mining Association (NMA) expressed
their belief that health risk is related to
fiber type and that OSHA’s risk
assessment is no longer adequate or
appropriate for us to use for the mining
industry. In developing this proposed
rule, we evaluated studies published
over the last 20 years since OSHA
completed its risk assessment, and
studies that specifically focused on
asbestos exposures of miners. We have
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found that these additional studies
confirm OSHA’s conclusions.
Section VIII of this preamble contains
a summary of our findings from
applying OSHA’s quantitative
assessment of risk to the mining
industry. The Preliminary Regulatory
Economic Analysis (PREA) contains a
more in-depth discussion of our
methodology and conclusions. We
placed our PREA in the rulemaking
docket and posted it on our Asbestos
Single Source Page at https://
www.msha.gov/asbestos/asbestos.htm.
We also placed OSHA’s risk assessment
in the rulemaking docket.
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A. Summary of Studies Used by OSHA
in Its Risk Assessment
OSHA relied on eight non-mining and
milling studies to estimate the risk of
lung cancer due to asbestos exposure.
They used four studies to estimate the
risk of mesotheliomas, and two studies,
involving three occupational cohorts,
for asbestosis. We briefly review these
studies below, since they also serve as
the basis of our risk assessment. For
completeness, we are including Table
VI–1 of some mining and milling
studies that have been conducted.
EPA, in its Integrated Risk
Information System (IRIS), presents a
useful table summarizing data from lung
cancer and mesothelioma studies. We
extracted that portion of their table
dealing with the studies included in
OSHA’s risk assessment. This is the
basis for Table VI–1 below.
TABLE VI–1.—SUMMARY OF LUNG CANCER AND MESOTHELIOMA STUDIES
Human data occupational group
Reported
average
exposure
(f-yr/mL)
Fiber type
Percent (%)
increase in
cancer per
f-yr/mL
Reference
Lung Cancer
Friction Products .......................
Textile Products ........................
Cement Products ......................
Chrysotile ..................................
Mostly Chrysotile .......................
Mixed (Amosite, Chrysotile,
Crocidolite).
32
44
112
0.058
2.8
6.7
Asbestos Products ....................
Mixed (Amosite, Chrysotile,
Crocidolite).
Chrysotile ..................................
Amosite .....................................
Mixed (Amosite, Chrysotile,
Crocidolite).
Mixed (Amosite, Chrysotile,
Crocidolite).
374
0.49
Henderson and Enterline, 1979.
200
67
300
1.1
4.3
0.75
Peto, 1980.
Seidman et al., 1979; Seidman, 1984.
Selikoff et al., 1979.
89
0.53
Weill et al., 1979.
Textile Products ........................
Insulation Products ....................
Insulation Workers ....................
Cement Products ......................
Berry and Newhouse, 1983.
Dement et al., 1982.
Finkelstein, 1983.
Mesotheliomas
Cement Products ......................
Textile Products ........................
Insulation Products ....................
Insulation Workers ....................
1. Lung Cancer
a. Berry and Newhouse, 1983
Berry and Newhouse (1983)
conducted a retrospective mortality
study (1942–1980) using data from an
English factory that manufactured
asbestos-containing friction materials
(e.g., brake blocks, stair treads). There
were 13,460 workers included in this
study, of which two-thirds were men.
Most had worked in this factory for 2–
10 years. The asbestos exposures
generally involved chrysotile, although
this site also had used crocidolite for
two brief periods, one from 1922–1933
and a second from 1939–1944.
Personal air sampling for the
assessment of asbestos concentrations in
this factory began in 1968. Fiber levels
for time periods prior to 1968 were
‘‘estimated by reproducing earlier work
conditions using detailed knowledge of
when processes were changed and
exhaust ventilation introduced.’’
Asbestos fiber concentrations were
determined over four time periods: Pre1931, 1932–1950, 1951–1969, and 1970–
1979. Before 1931, asbestos levels
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1.2 E–5 Finkelstein, 1983.
67
400
375
Mixed (Amosite, Chrysotile,
Crocidolite).
Chrysotile ..................................
Amosite .....................................
Mixed (Amosite, Chrysotile,
Crocidolite).
3.2 E–6 Peto et al., 1982.
1.0 E–6 Seidman et al., 1979; Seidman, 1984.
1.5 E–6 Selikoff et al., 1979.
typically exceeded 20 f/mL throughout
the factory. From 1932–1969, asbestos
levels decreased and most exposures
ranged from 2–5 f/mL. After 1970, levels
decreased to below 1 f/mL.
Berry and Newhouse (1983) did not
detect excessive mortality at this factory
over the period 1942 to 1980. OSHA
noted, however, the relatively short
duration of employee exposures and the
short follow-up period (e.g., less than 20
years for 33 percent of the men). In the
preamble to their 1986 asbestos rule,
OSHA stated,
* * * Because of the short follow-up period
used, OSHA does not believe that the nonsignificant increases in lung cancer mortality
found by these investigators [Berry and
Newhouse] contradict the findings from other
studies which show that low-level exposure
to asbestos has resulted in excessive
mortality from lung cancer * * *
b. Dement et al., 1982
Dement et al. (1982) conducted a
retrospective cohort mortality (1930–
1975) study of 768 men. These men had
worked in an asbestos textile factory
located in South Carolina where ‘‘only
an insignificant quantity of asbestos
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fiber other than chrysotile was ever
processed.’’ The men in this study had
at least 1 month of employment between
January 1, 1940 and December 31, 1965.
Dement et al. then followed the cohort
for another 10 years.
Air samples were collected in this
factory between 1930 and 1975 to
determine asbestos levels. Impinger
samples were collected prior to 1965;
then membrane filter sampling was
introduced. Membrane filter sampling
fully replaced the impinger method in
1971. There were 193 air samples
collected in 1930–1945, 183 in 1945–
1960, and 5,576 in 1960–1975. The
estimated mean asbestos exposure levels
by job and calendar time periods, using
linear regression models, were as high
as 78 f/cc before 1940 and generally
ranged from 5–10 f/cc after 1940.
Dement et al. (1982) demonstrated a
linear dose-response relationship for
lung cancer mortality that did not
appear to have a threshold. They also
found a linear dose-response
relationship for non-malignant
respiratory disease, other than upper
respiratory infection, influenza,
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pneumonia, or bronchitis. Like the lung
cancer data, the dose-response
relationship for non-malignant
respiratory disease did not appear to
have a threshold.
OSHA’s 1986 rulemaking considered
that Dement et al.’s report of excess risk
at low cumulative [asbestos] exposures
was well supported because of their
‘‘* * * careful estimation of exposure
histories for members of the cohort
* * *’’.
c. Finkelstein, 1983
Finkelstein (1983) studied a group of
328 men who worked in an Ontario,
Canada, factory that manufactured
asbestos-cement pipe and rock-wool
insulation. Men selected to participate
in this study began working at the
factory prior to 1961 and worked for the
company for at least 9 years. Finkelstein
divided the men into three groups based
on estimated levels of asbestos
exposure: 186 in production (consistent
exposure), 55 in maintenance
(intermittent exposure), and 87 controls
(minimal exposure). The asbestos
exposures involved chrysotile and
crocidolite, both of which the factory
mixed with cement and silica. This
study report did not indicate the
proportions of asbestos and silica used
in the cement.
Air samples were collected to assess
asbestos levels at this cement factory.
Impinger sampling was conducted
between 1943 and 1968. In 1969–1970,
the factory began to use the personal
membrane filter sampling method and
used this sampling data to classify the
men who worked in cement production
according to their probable cumulative
asbestos exposure. They used three subgroups (A, B, C) of estimated exposure
ranges and means as follows:
d. Henderson and Enterline, 1979
In 1979, Henderson and Enterline
published an update of their 1941–1967
mortality study. The extended study
provided data through 1973 and
included 1,075 men who had worked
for an asbestos company in the United
States for an average of 25 years. Most
of the workplace exposures involved
chrysotile, although some involved
amosite or crocidolite.
Henderson and Enterline conducted
impinger sampling to determine
asbestos levels for this study and
reported asbestos concentrations in
millions of particles per cubic foot
(mppcf). They also identified five
cumulative exposure categories (87, 255,
493, 848, and 1,366 fiber-years/cc) by
converting their original data, reported
in mppcf, to f/cc using a factor of 1:1.4
as discussed in the 1986 OSHA asbestos
rule (51 FR 22617).
For the period 1941–1973, Henderson
and Enterline (1979) found that this
cohort had an overall mortality rate that
was about 20 percent higher than that of
males in the general population. This
increase in mortality rate was mainly
due to lung cancer and other respiratory
diseases.
OSHA (1986) noted that the excess
mortality risk found by Henderson and
Enterline (1979) was less than that
found by Dement et al. (1982).
Henderson and Enterline, however,
studied retired asbestos workers, which
‘‘constitute a select group of survivors’’
(51 FR 22617), and which might explain
the difference in results of these two
mortality studies.
e. Peto, 1980
Peto (1980) continued the study of
workers in an asbestos textile factory in
England. His paper, published in 1980,
was an extension of two earlier reports,
one by Doll (1955) and a second by Peto
CUMULATIVE EXPOSURE
et al. (1977). In this updated study
[Fiber-years/mL]
(1980), Peto included 679 men who
were hired in 1933 or later, and who
Range
Mean
had been employed by the company for
Subgroup A ...............
8–69
44 at least 10 years by 1972. Peto divided
Subgroup B ...............
69–121
92 the workers into two cohorts: those first
Subgroup C ..............
122–420
180 exposed before 1951 (Cohort 1, n = 424
men) and those first exposed during or
Finkelstein also relied on detailed
after 1951 (Cohort 2, n = 255 men). The
employment histories and medical
National Health Central Register and
records for each man in the study.
factory personnel followed the workers
Finkelstein (1983) found that the
until 1978. The exposures in this textile
asbestos-exposed workers had all-cause factory involved chrysotile.
mortality rates that were twice that of
Although routine measurements of
the general Ontario population. He also
asbestos levels were not made prior to
reported that the mortality rates due to
1951, Peto et al. (1977) had estimated
malignancies and the deaths attributable the workers’ exposures in an earlier
to lung cancer were five and eight times study. Between 1951 and 1961, a
those of the general population,
thermal precipitator was used to sample
respectively.
for asbestos, then was gradually
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replaced by membrane filters. In this
study, Peto revised earlier estimates of
asbestos exposure concentrations and
reported mean levels in fibers/mL for
six selected years as follows: 32.4
(1951), 23.9 (1956), 12.2 (1961), 12.7
(1966), 6.7 (1971), and 1.1 (1974). Peto
et al. then used these values to calculate
cumulative exposures. The average
cumulative exposure for men first
exposed to asbestos during or after 1951
(i.e., Cohort 2) was 200–300 fiber-years/
mL.
Peto (1980) confirmed earlier
conclusions by Doll (1955) and Peto et
al. (1977) that there was excess lung
cancer mortality in this asbestos textile
factory. Although Peto et al. (1977)
suggested a dose-response relationship
for lung cancer using measurements
from a static dust sampler, Peto did not
demonstrate such a dose-response
relationship in this later study (1980).
f. Seidman et al., 1979 (With Update to
OSHA in 1984)
Seidman et al. (1979) conducted a
mortality study (1946–1977) of 820 men
who worked in an amosite factory in
New Jersey. This factory supplied the
U.S. Navy with insulation for pipes,
boilers, and turbines. The men in this
study were first employed between 1941
and 1945 and were followed for 35
years. Due to wartime conditions,
however, there was a changing
composition of the workforce. Seidman
et al. (1979) stated that—
This resulted in a unique experience; men
with a very limited duration of intense
exposure to Amosite asbestos, followed by
long observation * * *
The men were classified according to
the time in which they came into direct
contact with the amosite: Less than 1
month, 1 month, 2 months, 3–5 months,
6–11 months, 1 year, or 2 or more years.
Thus, this cohort is unlike those of other
studies where workers were exposed to
asbestos for long periods, often 20 or
more years.
In this amosite factory, there were no
direct measurements of asbestos levels.
The determination of asbestos
concentrations was made solely by
analogy with another factory in which
air sampling was done in the late 1960’s
and in the 1970’s. Seidman et al.
reported that, in samples taken in this
latter factory in October of 1971,
asbestos counts averaged as high as 23
f/mL.
Seidman et al. (1979) demonstrated
that the amosite workers were at risk of
developing lung cancer and dying from
this disease. Seidman et al. (1979)
concluded that—
• Prolonged follow-up is necessary to
evaluate the effects of asbestos on
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health, especially with lower
concentration or shorter duration
exposures.
• Asbestos retained in tissues may
continue to produce adverse effects long
after the exposure may have stopped.
• The length of the latency period for
asbestos-related diseases depends
directly on the dosage and the age at
which exposure takes place. For
example, older workers will show a
more pronounced and quicker effect
than younger workers with the same
level of exposure.
• The longer the time after first
exposure to asbestos, the more
pronounced the excesses in mortality.
• Reducing the asbestos exposure
(lowering the dosage) can both delay the
occurrence of adverse effects (e.g., time
to death) and lower the frequency of
their occurrence (e.g., fewer deaths).
In 1984, Seidman updated his earlier
work by adding 593 cases involving
deaths that occurred 5–40 years beyond
each man’s first amosite exposure.
Seidman again developed a
classification scheme, but now he based
it on cumulative exposure to amosite
and not on time alone. The exposure
categories were less than 6, 6–11.9, 12–
24.9, 25–49.9, 50–99.9, 100–149.9, 150–
249.9, and 250 or more fiber-years/cc.
Using this new information, he was able
to demonstrate an exposure-response
relationship for lung cancer mortality.
g. Selikoff et al., 1979.
Selikoff et al. (1979) conducted a
mortality study (1943–1976) of 17,800
men who belonged to the insulation
workers’ union. Members of this
insulation union worked mainly in
construction in the United States and
Canada, but some worked in refineries,
industrial plants, shipyards, and power
plants. Selikoff et al. (1979) described
the content of the asbestos insulation as
follows.
Until approximately the early 1940s,
chrysotile alone was utilized in the
manufacture of the asbestos insulation
products used by these men. Amosite began
to be used in the mid-1930s in small
quantities but became more widely utilized
during World War II and subsequently.
The ages of men in this study ranged
from 15 to over 85 years and Selikoff et
al. (1979) established a series of ‘‘age
categories,’’ each including a 5-year age
span (e.g., 15–19 years, 20–24 years,
etc.) Those men age 85 or older were
grouped together. The investigators
identified the time at which each man
was first exposed to asbestos and then
separated the data into a series of
categories based on how long it had
been since their first exposure (e.g., less
than 20, 20–34, and 35 or more years
ago).
Selikoff et al. (1979) reported that few
measurements were made to assess
asbestos levels in insulation work until
the mid-1960’s. For this reason, they
estimated exposure levels using
reconstructions of past work conditions
and extrapolations of more current
measurements to past conditions. They
concluded that insulation workers
would have been exposed to TWA
concentrations of 4–12 f/mL.
Selikoff et al. (1979) concluded that
the asbestos insulation workers were at
‘‘extraordinary increased risk of death of
cancer and asbestosis.’’ The study had
found an excessive number of lung
cancers (486) in this cohort, particularly
at 15–35 years after the first exposure to
asbestos. This figure was even more
striking when compared to the expected
number of lung cancer cases (106) for
this same group of men.
(1979), however, did not provide the
proportion of silica in the asbestos
cement mixture.
Impinger sampling was conducted in
this factory to determine asbestos levels.
The sampling results were reported in
millions of particles per cubic foot
(mppcf). Based on sampling data, Weill
et al. (1979) defined five categories of
exposure in mppcf/year as follows: Less
than 10, 11–50, 51–100, 101–200, and
more than 200. OSHA (51 FR 22618)
converted the original data of Weill et
al. (1979) from mppcf/year to fiberyears/cc using a factor of 1:1.4, as given
in the 1986 OSHA rule (51 FR 22617).
This yielded the following exposure
categories in fiber-years/cc: Less than
14, 15–70, 71–140, 141–280, more than
280.
Weill et al. (1979) found excess
mortality due to cancers, mainly lung
cancer, in men whose cumulative
exposures were moderate (141–280
fiber-years/cc) to high (greater than 280
fiber-years/cc). About 25 percent of their
cohort, however, was lost in the followup period. For the purpose of the study,
Weill et al. assumed they were alive.
This assumption may have led to an
underestimation of lung cancer risk. For
this reason, OSHA (51 FR 22618) stated
its opinion as follows:
h. Weill et al., 1979.
* * * the presence of an excess risk of
mortality from lung cancer could not be ruled
out for the cohorts in these exposure
categories. [The other three, lower exposure
categories defined by Weill et al., 1979.]
Weill et al. (1979) conducted a
mortality study of 5,645 men who had
at least 1 month of continuous
employment before January 1, 1970 in
one of two asbestos cement building
materials plants in New Orleans,
Louisiana. The men in this study had
worked at some time during the 1940’s
to the mid-1970’s. The investigators
followed this cohort for at least 20 years
and found that—
For both plants, 7 percent [of the men]
were initially employed before 1940, 76
percent during the 1940s, and 17 percent
during 1950 to 1954. Sixty percent were
employed for less than one year, 24 percent
for one to 10 years, and 16 percent for more
than 10 years.
The asbestos exposures mainly
involved chrysotile, although the two
plants also processed crocidolite and
amosite. The cement products were
comprised of about 15–28 percent
asbestos and some silica. Weill et al.
2. Mesotheliomas
a. Finkelstein, 1983.
We reviewed the most important
aspects of this study above. (See section
VI.A.1.) Based on death records,
Finkelstein (1983) found 11
mesotheliomas among the total of 58
deaths in his study. The mean age at
which these men were first exposed to
asbestos was 25 years, and their mean
latency period for mesotheliomas was
25 years. The mean age at death was 51
years, and none was over 60 years. This
demonstrates that death follows quickly
after this disease becomes evident.
Finkelstein noted that the rates of
death from mesotheliomas were
proportional to the magnitude of
cumulative asbestos exposure, as shown
in Table VI–2 below.
TABLE VI–2.—MESOTHELIOMAS MORTALITY RATES COMPARED TO EXPOSURE
Estimated
exposure
range
(fiber-years/
mL)
Mesotheliomas
mortality rates
(per 1,000 man-years)
1.9 ............................................................................................................................................................................
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8–69
Estimated
mean
exposure
fiber-years/mL)
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TABLE VI–2.—MESOTHELIOMAS MORTALITY RATES COMPARED TO EXPOSURE—Continued
Estimated
exposure
range
(fiber-years/
mL)
Mesotheliomas
mortality rates
(per 1,000 man-years)
4.9 ............................................................................................................................................................................
11.9 ..........................................................................................................................................................................
Based on the exposure-response data,
Finkelstein concluded, ‘‘* * * the
relation is compatible with a linear
function through the origin * * *.’’
Accordingly, Finkelstein’s data suggest
the lack of a threshold for
mesotheliomas.
b. Peto et al., 1982.
Peto et al. (1982) evaluated
mesothelioma mortality (1967–1979) in
the same group of 17,800 insulation
workers previously described by
Selikoff et al. (1979). We reviewed the
salient features of Selikoff et al. (1979)
above. (See section VI.A.1.) Members of
this insulation workers’ union worked
in the United States and Canada and
were exposed to chrysotile and amosite.
Peto et al. (1982) reported ‘‘a high
incidence’’ of mesotheliomas in this
cohort. There were 236 deaths from
mesotheliomas, of which 87 were
pleural and 149 were peritoneal. They
closely examined each man’s age at the
first asbestos exposure and the number
of years since his first exposure. Peto et
al. (1982) concluded that mesothelioma
mortality was strongly dependent on the
number of years since the first asbestos
exposure, but was independent of the
age at the first exposure. They stated—
Mesothelioma death rates in asbestos
workers appear to be proportional to the
third or fourth power of time * * * Age at
first exposure has little or no influence,
however, which supports the multi-stage
model of carcinogenesis * * *
mesotheliomas may constitute a high
proportion of cancer deaths resulting from
early exposure to asbestos.
Peto et al. (1982) also reviewed
mesothelioma mortality data from
several other studies in addition to
those from Selikoff et al. (1979). They
were interested in determining if they
could establish a relationship between
deaths from mesotheliomas and fiber
type. Although there were some data to
suggest that deaths from mesotheliomas
were more common in men who worked
with amphiboles (e.g., crocidolite), Peto
et al. (1982) were cautious when
drawing conclusions. They stated that—
Chemical [and physical] differences
between different fibre types may also be
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important, but until carcinogenic effects of
such differences have been demonstrated, it
would seem sensible to concentrate on fibre
dimension rather than mineral type in
developing dose-response relationships.
* * * It may therefore be dangerously
optimistic to attribute the substantial
incidence of pleural mesothelioma among
chrysotile factory workers to occasional
crocidolite exposure * * *
c. Seidman et al. 1979 (With Update
to OSHA in 1984).
We reviewed the salient features of
this study and its update above. (See
section VI.A.1.) Based on death records,
Seidman et al. (1979) found 14
mesotheliomas among the total 528
deaths in their study. They reported an
additional three mesotheliomas in their
update. OSHA commented that this was
‘‘a finding of great significance given the
rarity of the disease’’ (51 FR 22617).
d. Selikoff et al. (1979).
The salient features of this study were
reviewed above. (See section IV.A.1.)
Based on death records, Selikoff et al.
(1979) found 38 mesotheliomas (pleural
and peritoneal) in their initial cohort of
632 asbestos insulation workers. There
were 223 deaths in this part of their
study (1943–1976). Some of these
deaths from mesotheliomas occurred
20–34 years after the first exposure to
asbestos, described by the authors as
‘‘duration from onset.’’ For most men
who died from mesotheliomas,
however, it was 35 or more years after
their first exposure.
In the second and much larger cohort
(n = 17,800) of Selikoff et al. (1979),
there were 175 deaths due to
mesotheliomas of the total 2,271 deaths
in this group. Some (14) of these deaths
caused by mesotheliomas occurred 15–
24 years after the first asbestos
exposure, while most (161) were
recorded 25 or more years after the first
exposure. Selikoff et al. (1979) had been
unable to provide expected death rates
for mesotheliomas due to their rarity in
the general population. This study
demonstrated an unequivocal
association between mesotheliomas and
prior asbestos exposure. In the 25 years
since this paper was published, there
has been no evidence to the contrary.
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70–121
122–420
Estimated
mean
exposure
fiber-years/mL)
92
180
3. Asbestosis
a. Berry and Lewinsohn, 1979.
Berry and Lewinsohn (1979) studied
the same group of textile workers that
was originally described by Berry et al.
(1979) and, thus, a short summary of the
original paper is presented here.
Berry et al. (1979) studied a group of
379 men who worked in an asbestos
textile factory located in northern
England. Most of the worker exposures
involved chrysotile, although this site
also used crocidolite. Asbestos fiber
levels were measured in this factory
since 1951 and had been estimated
since 1936. Berry et al. defined two
cohorts. One included men who were
first employed between 1933 and 1950,
and were still working in this textile
factory in 1966. The other included men
who were employed after 1966, and had
worked for at least 10 years in this
textile factory. Berry et al. (1979) found
relationships between cumulative
asbestos exposure and crepitations
(abnormal lung sounds), possible
asbestosis, and certified asbestosis.
As noted above, Berry and Lewinsohn
(1979) used data from the same textile
factory as that described by Berry et al.
(1979); but Berry and Lewinsohn (1979)
defined two different cohorts. One
included men who were first employed
before 1951. The other included men
first employed after 1950. Berry and
Lewinsohn (1979) plotted the incidence
of cases of possible asbestosis against
the cumulative asbestos exposure up to
1966. They stated—
The data are compatible with a linear
relationship through the origin [indicating no
threshold], with no statistically significant
difference between the two groups [cohorts].
b. Finkelstein, 1982.
Finkelstein (1982) studied a group of
201 men who worked in a factory in
Ontario, Canada, that manufactured
asbestos-cement pipe and rock-wool
insulation. Finkelstein defined two
subsets in his study population: A group
of 157 production workers and a group
of 44 maintenance workers. The men
selected to participate in this study
worked in the pipe or board shop for at
least one year prior to 1961 and had
been employed at least 15 years. Most
of the asbestos exposures involved
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chrysotile and crocidolite, both of
which were mixed with cement and
silica.
Between the 1940’s and 1968,
impinger sampling was conducted to
assess total dust levels. In 1969/1970,
the company began to conduct quarterly
personal sampling for asbestos using the
membrane filter method. Finkelstein
used the results of such sampling as
baseline values for various jobs.
Of the workers in this study, 39
percent of those in production and 20
percent of those in maintenance had
certified asbestosis. Finkelstein
demonstrated that there was a
relationship between cumulative
asbestos exposure and certified
asbestosis. He describes the exposureresponse curve as sigmoidal, a shape
commonly observed in toxicology. The
curve also appears to intersect the
origin, which suggests a lack of
threshold.
B. Models Selected by OSHA (1986) for
Specified Endpoints and for the
Determination of Its PEL and STEL
Based on their critical review of the
studies described above (see section
VI.A), OSHA (51 FR 22631)
concluded—
* * * asbestos exposure causes lung
disease, respiratory cancer, mesothelioma,
and gastrointestinal cancer. * * * excess
disease risk has been observed at cumulative
exposures at or below those permitted by the
existing OSHA 8-hour permissible exposure
limit [PEL] of 2 f/cc. In addition, OSHA has
made risk estimates of the excess mortality
from lung cancer, mesothelioma,
gastrointestinal cancer, and the incidence of
asbestosis using mathematical models * * *
The following is a summary of the
mathematical models that OSHA used
in its asbestos risk assessment.
1. Lung Cancer
For lung cancer, OSHA (1986) relied
on a relative risk model that was linear
in dose, as described by the following
equation:
RL = RE[1 + (KL)(f)(dt-10)]
Where:
RL = Predicted lung cancer mortality.
RE = Expected lung cancer mortality in
the absence of asbestos exposure.
KL = Slope of the dose-response
relationship for lung cancer.
f = Asbestos fiber concentration (f/cc).
d = Duration of the exposure (minus 10
years to account for latency).
The following list gives the KL values
for the eight studies used by OSHA.
OSHA (51 FR 22637) used KL = 0.01, the
geometric mean of these eight studies,
in their risk assessment.
Study
KL
Berry and Newhouse, 1983 ....
Dement et al., 1982 ................
Finkelstein, 1983 ....................
Henderson and Enterline,
1979 ....................................
Peto, 1980 ..............................
Seidman et al., 1979;
Seidman, 1984 ....................
Selikoff et al., 1979 .................
Weill et al., 1979 .....................
0.0006
0.042
0.048
0.0047
0.0076
0.045
0.020
0.0033
2. Mesotheliomas
For mesotheliomas, OSHA (1986)
relied on an absolute risk model that is
linear in dose, but exponentially related
to the time after the first exposure to
asbestos. The following three equations
describe the risk.
ARM = (f)(KM)[(t-10)3 ¥ (t-10-d)3], for t
> 10 + d
ARM = (f)(KM)[(t-10)3], for 10 + d > t >
10
ARM = 0, for 10 > t
Where:
RM = Excess risk of mesotheliomas.
f = Asbestos fiber concentration.
KM = Slope of the dose-response
relationship for mesotheliomas.
d = Duration of the exposure.
t = Time after the first exposure to
asbestos.
The following list gives the KM values
for the four studies used by OSHA.
OSHA (51 FR 22640 and 22642) used
KM = 1 × 10¥8, the ratio of KM/KL, rather
than KM = 2.91 × 10¥8, the geometric
mean of these four studies, to account
for the bias in its analysis and avoid
overestimation of mesotheliomas in
their risk assessment.
KM(10¥8)
Study
Finkelstein, 1983 ....................
Peto et al., 1982 .....................
Seidman et al., 1979;
Seidman, 1984 ....................
Selikoff et al., 1979 .................
12
0.7
5.7
1.0
3. Asbestosis
For asbestosis, OSHA (1986) relied on
an absolute risk model that was linear
in cumulative dose. The following
equation describes the lifetime
incidence of asbestosis:
RA = m(f)(d)
Where:
RA = Predicted lifetime incidence of
asbestosis.
f = Asbestos fiber concentration.
d = Duration of the exposure.
m = Slope of the linear regression.
OSHA stated (48 FR 51132), ‘‘the best
estimates of asbestosis incidence are
derived from the Finkelstein data ‘‘and
OSHA did not rely on the values for the
slope as determined by Berry and
Lewinsohn (1979). Thus, based on
Finkelstein’s data (1982) alone, the
slope (m) is 0.055 and the equation
becomes RA = 0.055(f)(d).
Using this linear model, OSHA also
calculated estimates of lifetime
asbestosis incidence at five exposure
levels of asbestos (i.e., 0.5, 1, 2, 5, 10 f/
cc) and published Table VI–3 (48 FR
51132), which we have reproduced
below. OSHA concluded that for
lifetime exposures to asbestos at
concentrations of 2 or 0.5 f/cc, there
would be a 5 percent or a 1.24 percent
incidence of asbestosis, respectively (48
FR 51132). Based on Finkelstein’s linear
relationship for lifetime asbestosis
incidence, OSHA later stated (51 FR
22646) that, ‘‘Reducing the exposure to
0.2 f/cc [a concentration not included in
Table VI–3] would result in a lifetime
incidence of asbestosis of 0.5%.’’
TABLE VI–3.—ESTIMATES OF LIFETIME ASBESTOSIS INCIDENCE
Percent (%) Incidence
Exposure level, fiber/cc
Finkelstein
0.5 ................................................................................................................................................
1 ...................................................................................................................................................
2 ...................................................................................................................................................
5 ...................................................................................................................................................
10 .................................................................................................................................................
Slope ............................................................................................................................................
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1.24
2.49
4.97
12.43
24.86
0.055
29JYP2
Berry (employed before
1951)
Berry (first employed after
1950)
0.45
0.89
1.79
4.46
8.93
0.020
0.35
0.69
1.38
*3.45
6.93
0.015
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TABLE VI–3.—ESTIMATES OF LIFETIME ASBESTOSIS INCIDENCE—Continued
Percent (%) Incidence
Exposure level, fiber/cc
Finkelstein
R2 .................................................................................................................................................
0.975
Berry (employed before
1951)
Berry (first employed after
1950)
0.901
0.994
* Note: 1.38 in original table was a typographical error. The text (48 FR 51132) and the regression formula indicate that 3.45 is the correct
percent.
C. OSHA’s Selection of Its PEL (0.1 f/cc)
Using the models described above in
section VI.B., OSHA estimated cancer
mortality for workers exposed to
asbestos at various cumulative
exposures (i.e., combining exposure
concentration and duration of
exposure). These data were published in
its 1986 risk assessment (51 FR 22644),
which we have reproduced in the
following Table VI–4.
It is clear from Table VI–4 that the
estimated mortality from asbestos-
related cancer decreases significantly by
lowering exposure. This is true
regardless of the type of cancer: lung,
pleural, peritoneal, or gastrointestinal.
Although excess relative risk is linear in
dose, the excess mortality rates in Table
VI–4 are not strictly linear in dose.68
TABLE VI–4.—ESTIMATED ASBESTOS-RELATED CANCER MORTALITY PER 100,000 BY NUMBER OF YEARS EXPOSED AND
EXPOSURE LEVEL
Cancer Mortality per 100,000 Exposed
Asbestos fiber concentration (fiber/cc)
Lung
Mesothelioma
Gastrointestinal
Total
1-year exposure
0.1 ....................................................................................................................
0.2 ....................................................................................................................
0.5 ....................................................................................................................
2.0 ....................................................................................................................
4.0 ....................................................................................................................
5.0 ....................................................................................................................
10.0 ..................................................................................................................
7.2
14.4
36.1
144
288
360
715
6.9
13.8
34.6
138
275
344
684
0.7
1.4
3.6
14.4
28.8
36.0
71.5
14.8
29.6
74.3
296.4
591.8
740.0
1,470.5
139
278
692
2,713
5,278
6,509
12,177
73
146
362
1,408
2,706
3,317
6,024
13.9
27.8
69.2
271.3
527.8
650.9
1,217.7
225.9
451.8
1,123.2
4,392.3
8,511.8
10,476.9
13,996.7
231
460
1,143
4,416
8,441
10,318
18,515
82
164
407
1,554
2,924
3,547
6,141
23.1
46.0
114.3
441.6
844.1
1,031.8
1,851.5
336.1
670.0
1,664.3
6,411.6
12,209.1
14,896.8
26,507.5
20-year exposure
0.1 ....................................................................................................................
0.2 ....................................................................................................................
0.5 ....................................................................................................................
2.0 ....................................................................................................................
4.0 ....................................................................................................................
5.0 ....................................................................................................................
10.0 ..................................................................................................................
45-year exposure
0.1 ....................................................................................................................
0.2 ....................................................................................................................
0.5 ....................................................................................................................
2.0 ....................................................................................................................
4.0 ....................................................................................................................
5.0 ....................................................................................................................
10.0 ..................................................................................................................
OSHA’s PEL for asbestos was 2 f/cc in
1983. Table VI–4 shows that after 45
years of exposure to asbestos at this
concentration, there would be an
estimated 6,411.6 deaths (per 100,000
workers). This is the sum of deaths from
4,416 lung cancers, 1,554
mesotheliomas, and 441.6
gastrointestinal cancers. By lowering its
PEL to 0.1 f/cc, OSHA decreased the
risk of cancer mortality to an estimated
68 Nicholson,
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336.1 deaths (per 100,000 workers),
which is the sum of deaths from 231
lung cancers, 82 mesotheliomas, and
23.1 gastrointestinal cancers.
As shown above in Table VI–3, there
is also a significant reduction in the
incidence of asbestosis by lowering
exposures. For example, the lifetime
incidence of asbestosis would be
reduced from 4.97 percent (4,970 cases
per 100,000 workers) at 2 f/cc to 1.24
percent (1,240 cases per 100,000
workers) at 0.5 f/cc. Using the linear
model described above [RA =
0.055(f)(d)], the incidence of asbestosis
can also be calculated at a concentration
of 0.1 f/cc (not included by OSHA in
Table VI–4) following 45 years of
exposure to asbestos. This yields 0.25
percent, or 250 cases per 100,000
workers. Thus, by lowering the 8-hour
TWA PEL from 2 f/cc to 0.1 f/cc, we
p. 53, 1983.
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would reduce the lifetime asbestosis
risk from 4,970 cases to 250 cases per
100,000 exposed miners.
Based on these reductions in cancer
deaths and asbestosis cases, OSHA
demonstrated that a lowering of the PEL
below 2 f/cc would ‘‘substantially
reduce that risk’’ (51 FR 22612). OSHA
also noted—
Evidence in the record ‘‘has shown that
employees exposed at the revised standards’’
PEL of 0.2 fiber/cc [OSHA’s 1986 standard]
remain at significant risk of incurring a
chronic exposure-related disease, but
considerations of feasibility have constrained
OSHA to set the revised PEL at the 0.2 fiber/
cc level.
When OSHA further reduced its PEL
from 0.2 to 0.1 f/cc in 1994, this
statement was still true and the PEL
continued to reflect technical feasibility
issues. OSHA stated (59 FR 40967)—
The 0.1 f/cc level leaves a remaining
significant risk. However as discussed below
[in OSHA’s 1994 Final Rule] and in earlier
documents, OSHA believes that this is the
practical lower limit of feasibility for
measuring asbestos levels reliably.
D. Applicability of OSHA’s Risk
Assessment to the Mining Industry
In its asbestos emergency temporary
standard, and in its proposed, amended,
and final asbestos rules (1983, 1984,
1986, 1992, 1994), OSHA discussed few
mining and milling studies and
excluded these data in their risk
assessment. OSHA (51 FR 22637) stated,
The distinct nature of mining-milling data
(and hence the estimate of KL from these
data) has been considered earlier. There is
some evidence that risks in the asbestos
mining-milling operations are lower than
other industrial operations due to differences
in fiber size. ‘‘Thus, in determining the KL
for the final rule, the data from mining and
milling processes were not considered.
OSHA suggested that the
proportionality constants (i.e., KL, KM),
also known as the slopes of the
respective dose response curves, from
mining and milling studies are lower
than the slopes for the studies included
in its risk assessment (51 FR 22632 and
22637). This difference in slopes may
suggest that the risk of asbestos-related
cancers is lower in miners and millers.
Because there is remaining significant
risk of asbestos-related cancer at the
OSHA PEL of 0.1 f/cc, we may be
accepting a higher estimate of risk by
relying on OSHA’s quantitative risk
assessment that excluded mining and
milling studies.
Although we are relying on OSHA’s
risk assessment, we also reviewed the
scientific literature to identify studies
that involved the exposure of miners
and millers to asbestos. Most of these
studies were conducted in Canada,
although some have been conducted in
Australia, India, Italy, South Africa, and
the United States. Table VI–5 lists some
of these mining and milling studies, in
chronological order, and gives the
salient features of each study. These
studies are in the rulemaking docket.
TABLE VI–5.—SELECTED STUDIES INVOLVING MINERS EXPOSED TO ASBESTOS
Author(s), year of publication
Study group, type of asbestos
Major finding(s) or conclusion(s)
Rossiter et al., 1972 ...........................................
Canadian miners and millers, Chrysotile .........
Becklake, 1979 ...................................................
Canadian miners and millers, Chrysotile .........
Gibbs and du Toit, 1979 ....................................
Irwig et al., 1979 .................................................
Canadian and South African miners,
Chrysotile.
South African miners, Amosite and crocidolite
McDonald and Liddell, 1979 ..............................
Canadian miners and millers, Chrysotile .........
Nicholson et al., 1979 ........................................
Canadian miners and millers, Chrysotile .........
Rubino et al., Ann NY Ac Sci 1979 ....................
Italian miners, Chrysotile .................................
Rubino et al., Br J Ind Med 1979 .......................
Solomon et al., 1979 ..........................................
Italian miners, Chrysotile .................................
South African miners, Amosite and Crocidolite
McDonald et al., 1980 ........................................
McDonald et al., 1986 ........................................
Canadian miners and millers, Chrysotile .........
U.S. miners, Tremolite .....................................
McDonald et al., 1980 ........................................
U.S. miners, Tremolite .....................................
Cookson et al., 1986 ..........................................
Australian miners and millers, Crocidolite .......
Amandus et al., 1987 .........................................
U.S. miners, and millers, Tremolite-Actinolite
Amandus and Wheeler, 1987 ............................
U.S. miners, and millers, Tremolite-Actinolite
Amandus et al., 1987 .........................................
U.S. miners, and millers, Tremolite-Actinolite
Armstrong et al., 1988 ........................................
Australian miners and millers, Crocidolite .......
Enarson et al., 1988 ...........................................
Canadian miners, Chrysotile ............................
McDonald et al., 1988 ........................................
U.S. miners, and millers, Tremolite .................
McDonald et al., 1993 ........................................
Canadian miners and millers, Chrysotile .........
Radiographic changes (opacities) related to
age and exposure.
Weak relationship between exposure and disease.
Need for workplace epidemiologic surveillance
and environmental programs.
Parenchymal radiographic abnormalities preventable by reduced exposure.
Lower risk of mesotheliomas and lung cancer
from chrysotile than crocidolite.
Miners and millers: At lower risk of
mesotheliomas, at risk of asbestosis (as
factory workers and insulators), at risk of
lung cancer (as factory workers).
Role of individual susceptibility in appearance
and progression of asbestosis.
Elevated risk of lung cancer.
Sign of exposure to asbestos: Thickened
interlobar fissures.
No statistically significant increases in SMRs.
A. Increased risk of mortality from respiratory
cancer.
B. Increased prevalence of small opacities by
retirement age.
No threshold dose for development of radiographic abnormality.
Part I: Increased prevalence of radiographic
abnormalities associated with past exposure.
Part II: Increased mortality from nonmalignant
respiratory disease and lung cancer.
Part III: Exposures below 1 f/cc after 1977, up
to 100–200X higher in 1960’s and 1970’s.
Increased mortality from mesotheliomas and
lung cancer.
Increased cough, breathlessness, abnormal
lung volume and capacity.
Low exposure and no statistically significant
SMRs.
Increased SMRs for lung cancer and
mesotheliomas as cohort aged.
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43971
TABLE VI–5.—SELECTED STUDIES INVOLVING MINERS EXPOSED TO ASBESTOS—Continued
Author(s), year of publication
Study group, type of asbestos
Major finding(s) or conclusion(s)
Dave et al., 1996 ................................................
Indian miners and millers, Chrysotile ..............
McDonald et al., 1997 ........................................
Canadian miners and millers, Chrysotile .........
Nayebzadeh et al., 2001 ....................................
Canadian miners and millers, Chrysotile .........
Ramanathan and Subramanian, 2001 ...............
Indian miners and millers, Chrysotile and
tremolite.
Higher exposures in surface than underground mines; higher exposures in mills
than mines; restrictive lung impairment and
radiologic parenchymal changes more common in millers.
Risk of mesotheliomas related to geography
and mineralogy of region; mesotheliomas
caused by amphiboles.
Respiratory disease related to regional differences in fiber concentration and not dimension.
Increased risk of cancer, restrictive lung disease, radiologic changes, and breathing difficulties; more common in milling.
These studies of miners and millers
provide further evidence of potential
adverse health effects from asbestos
exposure. MSHA found that many of the
observations presented in these studies
(e.g., age of first exposure, latency,
radiologic changes) are consistent with
those from studies of factory and
insulation workers. The exposure to
asbestos, a known human carcinogen,
results in similar disease endpoints
regardless of the occupation that has
been studied.
E. Significance of Risk
1. Defining ‘‘Significant’’ Risk: The
Benzene Case
We (MSHA) believe that this
proposed rule for asbestos meets the
requirements set forth by the OSHA
Benzene Case described below. We have
relied on OSHA’s risk assessment, the
studies used by OSHA in its
development, and our review of more
recent studies and mining studies,
which further support OSHA’s findings.
In the Benzene Case, Industrial Union
Department, AFL–CIO v. American
Petroleum Institute et al. (448 U.S. 607,
1980), the U.S. Supreme Court ruled
that, prior to the issuance of a new or
revised standard regulating
occupational exposures to toxic
materials, such as asbestos, OSHA is
required to make two findings:
• They must determine that a
‘‘significant’’ health risk exists, and
• They must demonstrate that the
new standard will reduce or eliminate
that risk.
In the preamble to its 1994 final
asbestos rule (59 FR 40966, 1994),
OSHA provided an interpretation of a
‘‘significant health risk’’. They stated,
OSHA has always considered that a
working lifetime risk of death of over 1 per
1000 from occupational causes is significant.
This has been consistently upheld by the
courts.
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When OSHA lowered its PEL for
asbestos from 2 to 0.2 f/cc (1986), and
then to 0.1 f/cc (1994), they used this
definition of a ‘‘significant health risk’’
and made the two findings as outlined
in the Benzene Case. With respect to the
first finding, OSHA estimated the excess
lifetime cancer risk to be 3.4 deaths per
1,000 workers exposed to asbestos at 0.1
f/cc for a working lifetime. OSHA stated
(51 FR 22646),
The finding that a significant risk exists is
supported by OSHA’s quantitative risk
assessment, which is based upon studies of
asbestos-exposed worker populations.
With respect to the second finding,
OSHA went on to say (51 FR 22647),
In accordance with the second element
[finding, sic] of the Supreme Court’s Benzene
decision on the determination of significant
risk, OSHA has determined that reducing the
permissible exposure limit for asbestos [from
2 f/cc, sic] to 0.2 f/cc is reasonably necessary
to reduce the cancer mortality risk from
exposure to asbestos. * * * significant risks
of asbestos-related cancer mortality and
asbestosis are not eliminated at the exposure
level that is permitted under the new
standard [0.2 f/cc, sic]; however, the
reduction in the risk of asbestos-related death
and disease brought about by promulgation
of the new standard is both significant and
dramatic.
OSHA concluded that the lowering of
their PEL from 0.2 to 0.1 f/cc would
‘‘further reduce a significant health
risk’’ (59 FR 40966–40967).
2. Demonstrating Significant Health
Risk for the Miner
The Federal Mine Safety and Health
Act of 1977 (Mine Act), Title I, section
101(a), requires MSHA
* * * to develop, promulgate, and revise
as may be appropriate, improved mandatory
health or safety standards for the protection
of life and prevention of injuries in coal or
other mines.
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Furthermore, section 101(a)(6)(A) of
the Mine Act requires MSHA to set
health or safety standards—
* * * on the basis of the best available
evidence that no miner shall suffer material
impairment of health or functional capacity
even if such miner has regular exposure to
the hazards * * * for the period of his
working lifetime.
A significant health risk exists for
miners exposed to asbestos at our
existing 8-hour full-shift exposure limit
of 2 f/cc. Miners, like the insulation
workers in the studies cited by OSHA,
are at risk of developing lung cancer,
mesotheliomas, and asbestosis. These
effects are significant and clearly
constitute a material impairment of
health and functional capacity. They
also emphasize the need for us to lower
our PEL. By lowering the 8-hour fullshift exposure limit to 0.1 f/cc, we
would significantly reduce the risk of
asbestos-related lung cancers,
mesotheliomas, and asbestosis.
3. Using the Experience of OSHA and
Current Studies to Demonstrate
Significant Risk
Under the Mine Act, section
101(a)(6)(A), MSHA must base its health
and safety standards on—
* * * the latest available scientific data in
the field, the feasibility of the standards, and
experience gained under this and other
health and safety laws.
In our proposed rule for asbestos, we
have relied heavily on the experience of
OSHA, which demonstrates the
feasibility of a 0.1 f/cc exposure limit for
asbestos. We believe that this limit is
technically and economically feasible
for the mining industry. (See section
VIII.B. Feasibility.) We also have
obtained and reviewed the latest
available scientific data on the health
effects of asbestos exposure. MSHA
concludes that these studies provide
further support of the significant risk of
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adverse health effects following
exposure to asbestos.
Using OSHA’s risk assessment, we
have demonstrated that a lowering of
our 8-hour full-shift exposure limit from
2 to 0.1 f/cc would significantly reduce
the risk of asbestos-related disease in
miners. MSHA believes that other
existing standards help reduce the
remaining significant risk at this new
0.1 f/cc PEL. For example, MSHA
requires the use of engineering and
work practice controls to reduce a
miner’s exposure to the PEL and, until
this concentration is reached, the use of
an approved respirator. MSHA also
requires the use of personal protective
clothing and equipment, as necessary,
for equipment repair and for
construction or demolition activities 69
and hazard communication and task
training.70 As long as miners are likely
to encounter asbestos, miners and mine
operators will need to follow adequate
safety procedures to ensure a reduction
of exposures. We anticipate risk
reduction to occur by the use of
engineering controls and accepted
industrial hygiene administrative
controls that effectively avoid disturbing
asbestos on mine property.
VII. Section-by-Section Discussion of
Proposed Rule
In the ANPRM, we asked commenters
for supporting information to help us
evaluate whether or not to—
• Lower our asbestos PEL,
• Revise our analytical methods and
criteria to make them more appropriate
for the mining industry, and
• Implement safeguards to limit takehome exposures.
We received almost 100 comments,
considered the commenters’ concerns,
and discussed them in the following
sections.
To make the standard easier to read,
we have divided the requirements in the
proposed standards into three
paragraphs: Definitions, Permissible
Exposure Limits (PELs), and
Measurement of Airborne Fiber
Concentration. For §§ 56/57.5001(b), the
metal and nonmetal asbestos standards,
we numbered the paragraphs (b)(1),
(b)(2), and (b)(3). For § 71.702, the coal
asbestos standard, we assigned the
paragraphs letters (a), (b), and (c).
A. Sections 56/57.5001(b)(1) and
71.702(a): Definitions
Our existing definition of asbestos is
consistent with several Federal
agencies’ regulatory provisions,
including OSHA’s. As discussed in
69 30
CFR 56/57.5005, 56/57.15006, and 71.701
70 30 CFR parts 46, 47, and 48.
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section II.B of this preamble and in the
existing regulatory language, asbestos is
not a definitive mineral name, but rather
a commercial name for a group of
minerals with specific characteristics.
Our existing standards clearly state that,
‘‘when crushed or processed, [asbestos]
separate[s] into flexible fibers made up
of fibrils’’ [§§ 56/57.5001(b)]; and ‘‘does
not include nonfibrous or
nonasbestiform minerals’’ (§ 71.702).
Although there are many asbestiform
minerals, the term ‘‘asbestos’’ in our
existing standards is limited to the
following six (Federal Six): 71
• Chrysotile (serpentine asbestos,
white asbestos);
• Amosite (cummingtonite-grunerite
asbestos, brown asbestos);
• Crocidolite (riebeckite asbestos,
blue asbestos);
• Anthophylite asbestos (asbestiform
anthophyllite);
• Tremolite asbestos (asbestiform
tremolite); and
• Actinolite asbestos (asbestiform
actinolite).
Substantive changes to the definition
of asbestos are beyond the scope of this
proposed rule. We recognize that there
are limitations in the general analytical
methods, such as PCM and TEM, used
to identify and quantify the Federal Six.
Without the use of more complicated
and costly analyses, it may not always
be possible to differentiate other
chemically similar amphiboles from the
Federal Six. Also, the International
Minerals Association has proposed
more specific nomenclature in the
literature to classify some of the
amphiboles.72 We decline to adopt such
classifications here, because they are
beyond the scope of this proposed rule,
and propose to continue to use the
existing regulatory designations.
However, we are proposing a few
nonsubstantive changes to the existing
regulatory language to clarify the
standard. These wording changes would
have no impact on the minerals that we
regulate as asbestos from that contained
in the existing standards. This proposed
rule would—
• Clarify the term ‘‘amosite,’’ a name
tied to asbestos from a specific
geographical region, by adding the
mineralogical term ‘‘cummingtonitegrunerite asbestos’’ parenthetically.
• Add a definition for fiber to be more
consistent with OSHA. This change
would clarify that the dimensional
criteria in our existing standards refer to
the asbestiform habit of the listed
minerals.
71 ATSDR, p.136, 2001; NIOSH Pocket Guide,
2003.
72 Leake et al., 1997.
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• Conform the asbestos standards for
metal and nonmetal mines, surface coal
mines, and the surface work areas of
underground coal mines by using the
same structure and wording in the rule
text. For example, we retain the
descriptive language ‘‘Asbestos is a
generic term for a number of hydrated
silicates that, when crushed or
processed, separate into flexible fibers
made up of fibrils’’ from the metal and
nonmetal standards rather than the
comparable language from the coal
standards. We believe that this
descriptive language assists mine
operators in understanding the scope of
the standard.
MSHA’s ANPRM did not specifically
solicit information about which
asbestiform minerals we should
regulate. Even so, some commenters
suggested that MSHA should expand its
definition of asbestos to include other
asbestiform minerals, so long as our
analytical method excluded the
counting of cleavage fragments. One
commenter recommended that the PEL
be reduced not only for the six currently
regulated asbestos minerals, but also for
other amphibole minerals in their
asbestiform habit. NIOSH commented
that cleavage fragments of the
serpentine minerals antigorite and
lizardite and amphibole minerals
contained in the series cummingtonitegrunerite, tremolite-ferro-actinolite, and
glaucophane-riebeckite should be
counted as asbestos if they meet the
counting requirements for a fiber (3:1
aspect ratio and greater than 5 µm in
length). Another commenter asked that
MSHA not include nonasbestiform
fibrous minerals and mineral cleavage
fragments when we perform
microscopic analysis of samples.
Most commenters did not want
MSHA to make changes to the fibers
regulated as asbestos in the existing
standards. Specifically, they do not
want us to address other asbestiform
amphiboles found in mineral deposits
because they may not pose the same
health problems that asbestos does.
Some said that it would be unreasonable
and expensive to try to meet exposure
limits for all these minerals. Other
commenters at MSHA’s public hearing
in New York (2002) stated that,
whatever they are called, these minerals
cause illness.
At this time, we decline to propose
substantive changes to the definition of
asbestos as suggested by some
commenters. These changes are beyond
the scope of this rulemaking. We will
continue to monitor the toxicological,
epidemiological, and mineralogical
research studies and other new
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information relevant to protecting the
health of miners.
B. Sections 56/57.5001(b)(2) and
71.702(b): Permissible Exposure Limits
(PELs)
MSHA currently limits a miner’s 8hour TWA, full-shift exposure to 2.0 f/
cc over a full shift; and limits a miner’s
short-term exposure to 10 f/cc over a 15minute sampling period for metal and
nonmetal miners and 10 f/cc for a total
of one hour in an 8-hour day for miners
at surface work areas of coal mines. We
are proposing to adopt OSHA’s 8-hour
TWA, full-shift exposure limit of 0.1 f/
cc and their 30-minute excursion limit
of 1.0 f/cc for the mining industry.
These actions would reduce by almost
20-fold the risk of asbestos-related
deaths from a lifetime exposure at
MSHA’s existing permissible exposure
limits. The proposed exposure limits,
however, were based on feasibility and
would not completely eliminate the
risk. We believe that the proposed
excursion limit would help reduce the
residual risk from long-term exposure at
the 0.1 f/cc 8-hour TWA, full-shift
exposure limit.
As noted by the OIG, the continued
occurrence of asbestos-related diseases
and deaths among miners emphasizes
the need to reduce asbestos exposures.
MSHA’s recent field sampling data
(2000 through 2003) show that 2 percent
of the total number of MSHA’s samples
exceed OSHA’s PEL of 0.1 f/cc based on
TEM analysis. This same data indicate
that 10 percent of the samples exceed
OSHA’s PEL of 0.1 f/cc based on PCM.
MSHA’s asbestos ANPRM requested
information to help us determine
appropriate exposure limits for the
mining industry, considering the health
risk and technological and economic
feasibility. We specifically asked what
would be an appropriate agency action
considering these levels, and if OSHA’s
asbestos exposure limits would afford
sufficient protection to miners. Most
commenters supported our adoption of
OSHA’s exposure limits.
As discussed below in section VII.C of
this preamble, we are proposing to
incorporate the generic elements of PCM
analytical methods for asbestos
exposure monitoring by referencing
Appendix A of OSHA’s asbestos
standard (29 CFR 1910.1001). Appendix
A lists both NIOSH 7400 and OSHA ID
160 as examples of analytical methods
that meet the equivalency criteria in
OSHA’s asbestos standard. The
evaluation or inclusion of other
protocols that deviate from the criteria
for counting fibers in our existing
standards is beyond the scope of this
rulemaking.
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1. Sections 56/57.5001(b)(2)(i) and
71.702(b)(1): 8-Hour Time-Weighted
Average (TWA), Full-Shift Exposure
Limit
Our sampling results indicate that
there is not widespread overexposure to
asbestos in the mining industry.
Recognizing this low exposure, many
industry commenters generally
supported reducing the PEL for asbestos
to the OSHA level of 0.1 f/cc, if MSHA
also ensured that the analytical method
only counted asbestos fibers. Labor
representatives supported reducing the
PEL for asbestos to the OSHA level of
0.1 f/cc and recommended that MSHA
propose additional requirements from
the OSHA asbestos standard.
Even though there was general
agreement among the commenters to the
ANPRM that MSHA should adopt
OSHA’s asbestos exposure limits, some
commenters from a community
association expressed concern about
asbestos originating at a local mine.
They seemed concerned not only with
the health of miners, but also with
exposures of people in relative
proximity to the mining operations.
They believe that any level of airborne
asbestos is unacceptable.
While we are concerned about the
spread of asbestos from mine sites into
the atmosphere, asbestos occurs
naturally in many types of soils and ore
bodies. Although comments concerning
the asbestos exposure of those living
close to a mining operation fall outside
the scope of this rule, the proposed
reduction in the permissible exposure
limits may reduce environmental levels
as well.
We are proposing an 8-hour TWA,
full-shift exposure limit of 0.1 f/cc. This
limit would significantly reduce the risk
of material impairment of health or
functional capacity for miners exposed
to asbestos.
2. Sections 56/57.5001(b)(2)(ii) and
71.702(b)(2): Excursion Limit
As previously discussed, asbestos
poses a long-term health risk to exposed
workers. There are no toxicological data
identifying a ‘‘dose-rate’’ 73 health effect
from exposure to airborne
concentrations of asbestos. ‘‘Dose-rate’’
effect means that a specific dose can
cause different health problems
depending on the length of exposure.
For example, asbestos does not seem to
have a ‘‘dose-rate’’ effect because
exposure to a high concentration over a
short time period poses no greater risk
of an adverse health effect than if the
worker received the same dose at a
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(51 FR 22709), 1986.
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43973
lower concentration over a longer time
period. An excursion limit sets
boundaries for peak episodes of
exposure that are not based on
toxicological data. We are proposing an
excursion limit for asbestos to help
maintain the average airborne
concentration below the full-shift
exposure limit. For example, the 8-hour,
TWA airborne asbestos concentration
would be 0.06 f/cc for miners exposed
to one 30-minute excursion per day at
1.0 f/cc and 0.13 f/cc for miners exposed
to two 30-minute excursions per day at
1.0 f/cc.
In the ANPRM, we requested
comments on an appropriate level for a
short-term exposure limit (67 FR 15134).
We specifically asked whether adopting
the OSHA limit of 1 f/cc over 30
minutes would afford sufficient
protection to miners in light of the
health risk and the technical and
economic feasibility of such a limit.
Commenters offered no objections to
adopting OSHA’s excursion limit for
airborne asbestos, and some agreed that
this level is appropriate.
a. OSHA’s Short-Term Exposure
Limit.
When OSHA issued its 1986 asbestos
standard, it decided not to issue an
explicit short-term exposure limit
(STEL). OSHA stated the basis for its
decision (51 FR 22709) as follows.
To summarize, OSHA is not promulgating
a short-term exposure limit for asbestos
because toxicological and dose-response
evidence fail to show that short-term
exposure to asbestos is associated with an
independent or greater adverse health effect
than is exposure to the corresponding 8-hour
TWA level; that is, there is no evidence that
exposure to asbestos results in a ‘‘dose-rate’’
effect. This is reflected in OSHA’s risk
models for lung cancer and mesothelioma,
which associate health risk with cumulative
dose. The decision not to promulgate a shortterm exposure limit for asbestos is consistent
with OSHA’s recent policy decision
described in the Supplemental Statement of
Reasons for the Final Rule for Ethylene Oxide
(50 FR 64) in which OSHA established that
short-term exposure limits for toxic
substances are not warranted in the absence
of health evidence demonstrating a dose-rate
effect.
OSHA’s decision not to issue a STEL
was challenged in Public Citizen Health
Research Group v. OSHA (796 F.2d
1505), 1986. The U.S. Court of Appeals
for the District of Columbia held that the
Occupational Safety and Health Act
compels OSHA to adopt a short-term
limit, if the rulemaking record shows
that it would further reduce a significant
health risk and is feasible to implement,
regardless of whether the record
supports a ‘‘dose-rate’’ effect.
Subsequently, OSHA found that
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compliance with a short-term limit
would further reduce a significant
health risk remaining after complying
with the 8-hour TWA, full-shift
exposure limit. OSHA also found that
the lowest excursion level which is
feasible both to measure and to achieve
primarily through engineering and work
practice controls is 1 f/cc measured over
30 minutes. For these reasons, in 1988,
OSHA promulgated an asbestos
excursion limit of 1 f/cc over a sampling
period of 30 minutes (53 FR 35610).
b. Minimum Detectable Level and
Feasibility of Measuring Short-Term
Excursions.
As discussed in OSHA’s 1986
asbestos final rule (51 FR 22686), the
key factor in sampling precision is fiber
loading. To determine whether the
analytical method described in
Appendix A of its asbestos standard
could be used to analyze short-term
samples, OSHA calculated the lowest
reliable limit of quantification using the
following formula:
C = [(f/[(n)(Af)])(Ac)]/[(V)(1,000)]
where:
C is fiber concentration (in f/cc of air);
f is the total fiber count;
n is the number of microscope fields
examined;
Af is the field area (0.00785 mm2) for a
properly calibrated Walton-Beckett
graticule;
Ac is the effective area of the filter (in
mm2); and
V is the sample volume (liters).
Table VII–1 was generated from the
above equation. The table shows that 1.0
f/cc measured over 30 minutes can be
reliably measured when pumps are used
at the higher flow rates of 1.6 Lpm or
more, using the 25-mm filters.
TABLE VII–1.—RELATIONSHIP OF SAM- proposing to retain this requirement for
PLING METHOD TO MEASUREMENT PCM analysis. The proposed rule would
require fiber concentration to be
OF ASBESTOS
Flow rate
(Lpm)
2.5
2.0
1.6
1.0
0.5
2.5
2.0
1.6
1.0
0.5
Sampling
time
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
15 minutes ..
.....................
.....................
.....................
.....................
30 minutes ..
.....................
.....................
.....................
.....................
Lowest level
reliably measured (f/cc)
using 25-mm
filters
1.05
1.31
1.63
2.61
5.23
0.51
0.65
0.82
1.31
2.61
We recognize that in some situations,
such as low background dust levels,
ower exposures could be measured;
however, the risk of overloading the
filter with debris increases when using
the higher flow rates. We can be
confident that we are measuring the
actual airborne concentrations of
asbestos, within a standard sampling
and analytical error (±25 percent), when
we use the minimum loading suggested
by the OSHA Reference Method (29 CFR
1910.1001, Appendix A). The excursion
limit of 1.0 f/cc for 30 minutes is the
lowest concentration that we can
measure reliably for determining
compliance with the excursion limit.
Some commenters supported MSHA’s
adoption of OSHA’s asbestos excursion
limit of 1.0 f/cc for 30-minutes. Many
other commenters offered no objections,
choosing to remain silent on this issue.
We have considered the comments and
are proposing an asbestos excursion
limit of 1.0 f/cc over a minimum
sampling time of 30 minutes.
C. §§ 56/57.5001(b)(3) and 71.702(c):
Measurement of Airborne Fiber
Concentrations
We currently require asbestos samples
to be analyzed by PCM for the initial
determination of exposure and
compliance with the PELs. We are
determined by PCM using a method
statistically equivalent to the OSHA
Reference Method in OSHA’s asbestos
standard (29 CFR 1910.1001, Appendix
A).
The OIG recommended that we use
TEM for the initial analysis of samples
collected to evaluate a miner’s personal
exposure to asbestos. In our 2002
asbestos ANPRM, we requested
information to help us determine the
benefits and feasibility of changing our
asbestos analytical method from PCM to
TEM for evaluating a miner’s exposure
to asbestos. For the reasons discussed in
this preamble, we cannot justify using a
TEM analytical method for the initial
determination of compliance with our
asbestos PELs.
1. Brief Description and Comparison of
Three Analytical Techniques
To ease understanding of the
discussion that follows, this section
briefly describes the three analytical
techniques that MSHA has used for
analyzing asbestos samples. All three
techniques involve counting fibers.
MSHA has used—
• Phase contrast microscopy (PCM)
on air samples to determine a miner’s
exposure for comparison with our
permissible exposure limits (PELs) for
asbestos.
• Transmission electron microscopy
(TEM) on the same air samples analyzed
by PCM when we need to confirm the
presence of asbestos and distinguish
asbestos from other fibers in the sample.
• Polarized light microscopy (PLM)
to analyze bulk samples collected from
an area suspected of having asbestos in
the ore or dust, not for air samples
collected to determine a miner’s
exposure.
Table VII–2 below presents a brief
summary of various features of these
three analytical techniques. The values
listed are approximate.
TABLE VII–2.—MSHA’S COMPARISON OF THREE ANALYTICAL TECHNIQUES 74 USED TO ANALYZE ASBESTOS SAMPLES
Criteria
PCM
TEM
Magnification ..................................
Up to 1,000X; typically 400–450X
Up to 1,000X; typically 10–45X.
Resolution ......................................
Sample Area Examined .................
Additional information ....................
0.2 µm ...........................................
Minimum: 100 fibers & 20 fields;
or 100 fields (0.157–0.785
mm2).
None .............................................
Up to 1,000,000X; typically
10,000X.
0.001 µm 75 ...................................
100 fibers or 4.4 mm2 minimum
(0.06–0.4 mm2)*.
Refractive index.
Microscope cost .............................
Analysis cost/filter ..........................
Analysis time/filter ..........................
$1,500–$2,000 ..............................
$10–$15 ........................................
0.25–0.5 hour ...............................
Crystal structure & elemental
composition.
$200,000–$300,000 ......................
$100–$400 ....................................
3–4 hours or more ........................
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Scan entire prepared sample (1
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$1,500–$2,000.
$10–$15.
0.25–0.5 hour.
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TABLE VII–2.—MSHA’S COMPARISON OF THREE ANALYTICAL TECHNIQUES 74 USED TO ANALYZE ASBESTOS SAMPLES—
Continued
Criteria
PCM
TEM
PLM
Degree of expertise of analysts .....
Requires a moderate level of expertise; 40 hours training minimum.
Requires a high level of expertise
and experience.
Requires a moderate level of expertise; 40 hours training minimum.
* NIOSH
7402 depends on loading: light–40 fields; medium–40 fields or 100 fibers; heavy–6 fields and 100 fibers.
2. Fiber Identification Using
Transmission Electron Microscopy
(TEM)
a. Advantages and Disadvantages of
TEM Analysis
The transmission electron microscope
(TEM), equipped with an energy
dispersive x-ray spectrometer (EDS) and
using selected area electron diffraction
(SAED) is generally capable of
identifying the mineralogy of individual
asbestos fibers. Even so, TEM does not
always have sufficient precision to make
definitive distinctions between closely
related minerals, such as between
winchite
[(NaCa)Mg4(Al,Fe3∂)Si8O22(OH)2] and
tremolite [Ca2Mg5Si8O22(OH)2].76
Because electron microscopes provide
greater magnification and greater image
clarity, including sharper threedimensional images than light
microscopes, TEM can detect fibers that
are undetectable using PCM. Routine
use of TEM analysis, however, would
have some significant disadvantages.
• Epidemiological data correlating
TEM asbestos exposure levels with
asbestos-related diseases is not available
for conducting a new risk assessment.
• TEM analysis is time consuming
and expensive, requiring highly skilled
personnel for instrument operation and
data interpretation, especially when
applied as the primary analytical
method.
• Few facilities offer TEM analysis for
asbestos air samples collected in a
mining environment.
Another disadvantage of TEM is that
it uses an even smaller amount of
sample than is used in PLM or PCM
analysis. Asbestos fibers may not be
present in the small portion of sample
examined under the electron
microscope, even when it is present in
the larger sample examined by PLM or
PCM. Despite its disadvantages, TEM
allows us to better identify asbestos
minerals in air samples collected in a
mine.
b. Use of TEM to Determine
Compliance with MSHA’s PELs.
74 MSHA’s summary of its literature reviews and
experience.
75 Clark, p. 5, 1977.
76 Leake et al., 1997.
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The OIG recommended that MSHA
use TEM for its initial analysis to
determine if an asbestos sample is over
the PEL. MSHA believes that analyzing
an airborne dust sample from a mine,
which might contain asbestos, requires
additional expertise not readily
developed through experience analyzing
samples known to contain asbestos. We
recognize that EPA routinely uses TEM
for the analysis of air samples collected
for asbestos abatement under the
Asbestos Hazard Emergency Response
Act (AHERA) and requires the use of
TEM to characterize workers’ asbestos
exposures (40 CFR part 763). MSHA
currently uses TEM on a limited basis,
when necessary, to verify the presence
of asbestos in samples. These samples
often contain few fibers among much
dust and a variety of other interferences.
In the ANPRM, we requested
comments on the use of TEM including
cost, availability, comparisons of PCM
to TEM, and a possible relationship of
TEM to a PEL. In response to the
ANPRM, some commenters suggested
that MSHA use TEM to augment PCM
measurements. Overall, industry
commenters did not recommend the use
of TEM for the initial analysis of fiber
samples for comparison to the PELs.
Commenters did not dispute additional,
confirmatory analysis of samples that
show possible exposure to asbestos in
excess of the PELs. NIOSH also did not
believe that TEM should be used for
routine monitoring even though they
consider TEM a valuable tool in mineral
identification. NIOSH comments stated
the reasons for not using TEM as the
primary method for determining
compliance with the PELs as (i) the lack
of health risk data associated with TEM,
(ii) the level of expertise required, and
(iii) the high cost.
(i) Lack of Health Risk Data Based on
TEM.
OSHA did not use analytical results
based on TEM in its original risk
assessment for asbestos. Although
attempts have been made,77 researchers
have not reported a strong, consistent
correlation between PCM and TEM
analyses. The relationships that are
reported are specific to the fiber type
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et al., 1987.
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and environment sampled.78 To set a
meaningful permissible exposure limit
based on TEM analysis, we must have
either—
• Peer-reviewed epidemiology or
toxicology studies relating TEM analysis
and adverse health effects, or
• A predictive relationship
correlating TEM and PCM for samples
collected in a mining environment.
(ii) Level of Expertise.
One commenter representing an
industry association at MSHA’s public
hearing in Charlottesville, Virginia
(2002) testified that TEM was not a
method for routine monitoring. This
commenter also pointed out—
* * *that very few commercial TEM labs
are competent to perform valid analyses of
the complicated mineralogical mixtures that
you find in mining and quarrying operations.
Another commenter at the
Charlottesville public hearing testified
that TEM is fallible. This commenter
said that electron diffraction patterns for
structurally similar minerals can be
difficult to distinguish from one
another. Each particle in the sample
may be of a different composition and
the analyst cannot assume that every
particle with the same shape is the same
mineral.
(iii) High Cost of TEM Analysis.
Several commenters representing an
industry association each commented
on the high cost of TEM analysis. One
commenter stated that, because the
variability of the measurement increases
at the lower concentrations, when the
PEL is lowered it is important to
increase the frequency of monitoring
and, therefore, the cost of sample
analysis becomes an issue.
3. Phase Contrast Microscopy (PCM) for
the Analysis of Personal Exposure
Samples
The use of PCM for quantitative
analysis of samples does not
differentiate between mineral species.
There is industry concern that
misidentification of fibers as asbestos
can lead to incorrect conclusions,
resulting in unnecessary expenses for
mining companies. PCM counting
schemes address the key problem of
78 Verma
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needing to make a relatively fast, costeffective evaluation of a situation in a
mine so as to protect miners from
danger to their health. PCM maintains
the integrity, meaning, and usefulness of
the analytical method for evaluating
samples relative to the historic health
data.79
a. Discussion of Microscope
Properties.
One issue commenters mentioned
repeatedly concerning PCM is the
limited resolution and magnification of
light microscopes compared to electron
microscopes.
(i) Resolution.
The resolution of the microscope is
the smallest separation between two
objects that will allow them to be
distinctly visible. The higher the
resolving power of a microscope, the
smaller the distance can be between two
particles and have them still appear as
two distinct particles. Resolution is
about 0.22 µm using PCM and 0.00025
µm using TEM. This means that where
the analyst sees a single fiber using
PCM, that same analyst might see a
number of thinner fibers using TEM.
(ii) Magnification.
The level of magnification is another
PCM microscopy issue. Magnification is
the ratio of the size that the object
appears under the microscope to its
actual size. PCM analytical methods
specify a magnification of 400 to 450
times (×) the object’s actual size. The
magnification using TEM can be
10,000X to 1,000,000X. This means that
the analyst sees a smaller amount of the
sample using TEM than when using
PCM.
b. Health Risk Data Based on PCM.
Historically, asbestos samples have
been analyzed by mass (weighing),
counting (microscopy), or a qualitative
property (spectroscopy). When
recommending an exposure standard for
chrysotile asbestos, the British
Occupational Hygiene Society
contended 80 that the microscopic
counting of particles greater than 5 µm
in length would show a relationship
with the prevalence of asbestosis similar
to those based on the mass of respirable
asbestos. Many scientific papers have
suggested that counting only fibers
longer than 5 µm would minimize
variations between microscopic
techniques 81 and improve the precision
of the results.82 Nonetheless, this
criterion was accepted as an index of
exposure, even though some believed
that, due to their possible health effects,
the smaller fibers should not be
excluded.83
In recommending an asbestos
standard in 1972, NIOSH suggested
using the same size criteria that the
British adopted. They also
recommended reevaluating these
criteria when more definitive
information on the biologic response
and precise epidemiologic data were
developed. When exposure data were
not obtained using PCM, NIOSH applied
a conversion factor to the non-PCM data
to estimate PCM concentrations for use
as the basis of a recommended
permissible occupational exposure
level.
A number of commenters testified
(Charlottesville, 2002) that PCM
methodology includes more than
asbestos when determining fiber
concentration in air. The commenters
suggested that the lower risk seen in
epidemiological studies relating PCM to
adverse health outcomes in miners was
possibly due to the background material
inherent in air samples taken in a
mining environment. They speculated
that the background material had been
counted and included in the estimated
asbestos concentrations. This may have
overestimated exposures and resulted in
a dilution of the dose-response
relationship presented in scientific
publications.
c. Subjectivity and Consistency of
Counting Asbestos Fibers
The fiber count obtained using the
PCM method is dependent on several
factors. These factors include the
analyst’s interpretation of the counting
rules, the analyst’s visual acuity, the
optical performance of the microscope,
and the optical properties of the
prepared sample.84 Much of the
variability is attributed to the ability of
the analyst to observe and size fibers.
The American Industrial Hygiene
Association (AIHA) Proficiency
Analytical Testing Program (PAT),
operated in cooperation with NIOSH,
maintains a database for historical data
relating to asbestos fiber counting using
PCM. This program, begun in 1972,
provides statistical evaluation of
laboratory performance on test samples.
At its inception in 1968, the method
used by laboratories participating in this
program was the U.S. Public Health
Service method (USPHS 68).85 The
counting rules for this method were
vague and required little microscope
standardization.
Work has been done to modify the
PCM method to address these
79 Wylie
et al., 1985.
et al., 1968.
81 ACGIH–AIHA, 1975.
82 Wylie, 2000.
80 Lane
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83 ACGIH–AIHA,
1975; NIOSH, 1972.
et al., 1982.
85 Schlecht and Shulman, 1995.
consistency issues.86 Commenters to our
asbestos ANPRM suggested that we
consider thoracic sampling to minimize
interference from large particles.
Testimony at MSHA’s public hearing in
Charlottesville (2002) presented a
counting technique based on the typical
characteristics of asbestos in air.
Another commenter stated that several
approaches have been tried to remove
non-asbestos minerals from samples,
such as low temperature ashing or
dissolution, but they would not be
useful for mining samples. Another
commenter suggested using a higher
aspect ratio to increase the probability
that the structures counted are fibers.
Several commenters suggested the
development of a new analytical
method.
Overall, commenters recognized that
it takes far less time to develop expertise
in counting fibers using PCM than in
developing expertise using TEM. NIOSH
has developed a 40-hour training course
for teaching analysts to count asbestos
fibers.
The availability of analyst training
courses, and the formation of
accreditation bodies requiring
laboratory quality assurance programs,
helps minimize the variations in
measurements between and within
laboratories. Accreditation bodies
require laboratories to use standardized
analytical methods. AIHA also has the
Asbestos Analyst Registry that specifies
criteria for competence, education, and
performance for analysts. In addition to
these programs, our incorporation of
OSHA’s Appendix A would help
minimize the subjectivity and increase
consistency of measuring airborne
asbestos concentrations by specifying
core elements of acceptable analytical
PCM methods.
4. MSHA’s Incorporation of OSHA’s
Appendix A
Commenters generally supported the
use of PCM for the initial analysis of
fiber samples for determining
compliance with the PELs. Commenters’
major concerns focused on fiber
counting procedures. Commenters
suggested that differential counting
techniques be developed to analyze air
samples for asbestos using PCM and
taking into consideration the fiber
morphology and the distributions or
populations of distinct fiber groups with
characteristic dimensions. Other
commenters stated that particle
characteristics could not reliably be
used to differentiate fibers from cleavage
fragments when examining relatively
small numbers of fibers.
84 Rooker
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In this rulemaking, we propose to
continue to use PCM to determine
asbestos concentrations. PCM was used
in the development of past exposure
assessments and risk estimates and is
relatively quick and cost-effective. Thus,
with respect to analytical methods, this
proposed rule is not substantively
different than our existing standards.
We also have added language to allow
for our acceptance of other asbestos
analytical methods that are at least as
effective in identifying potential
overexposures.
The OSHA Reference Method,
mandatory Appendix A to the OSHA
asbestos standard (29 CFR 1910.1001),
specifies the elements of an acceptable
analytical method for asbestos and the
quality control procedures that
laboratories performing the analysis
must implement. Paragraph (d)(6)(iii) of
OSHA’s asbestos standard (29 CFR
1910.1001) requires employers, who
must monitor for asbestos exposure, to
use a method for collecting and
analyzing samples that is equivalent to
the OSHA Reference Method (ORM),
and also describes the criteria for
equivalency. For the purpose of this
proposed rule, MSHA would consider a
method equivalent if it meets the
following criteria:
[from 29 CFR 1910.1001(d)(6)(iii)]
(A) Replicate exposure data used to
establish equivalency are collected in sideby-side field and laboratory comparisons;
and
(B) The comparison indicates that 90% of
the samples collected in the range 0.5 to 2.0
times the permissible limit have an accuracy
range of plus or minus 25 percent of the ORM
results at a 95% confidence level as
demonstrated by a statistically valid protocol;
and
(C) The equivalent method is documented
and the results of the comparison testing are
maintained.
Appendix A of OSHA’s asbestos
standard lists NIOSH 7400 and OSHA
ID–160 as examples of analytical
methods that meet these criteria. In
addition, there are other PCM analytical
methods for asbestos:
• The Asbestos International
Association (AIA), AIA RTM1,
‘‘Airborne Asbestos Fiber
Concentrations at Workplaces by Light
Microscopy (Membrane Filter Method).’’
• The International Organization for
Standardization (ISO), ISO
8672:1993(E), ‘‘Air quality—
Determination of the number
concentration of airborne inorganic
fibres by phase contrast microscopy—
Membrane filter method.’’
MSHA recognizes that there are
advantages and disadvantages of various
PCM analytical methods, especially as
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they relate to the processing of samples
collected in a mining environment. For
example, the ASTM dilution method (D
5755–95) for overloaded samples has
allowed laboratories to recover useable
results from airborne exposure samples
that, in the past, had been invalidated.
We note that both ASTM and the
National Stone Sand and Gravel
Association are pursuing the
development of an analytical method for
asbestos in mining samples. We would
consider analytical methods that afford
a better measurement alternative as they
become available. We believe that
allowing statistically equivalent
analytical methods would remove
barriers to innovation and technological
advancement.
We specifically request information
on additional criteria for equivalency for
use in evaluating alternative analytical
methods for the determination of
asbestos in air samples collected in a
mining environment. We also request
information about analytical methods
for which equivalency has already been
demonstrated.
5. MSHA Asbestos Control Program
In the ANPRM, we asked whether or
not our current sampling methods met
the needs of the mining community and
how mineral dust interferences could be
removed from mining samples. The
ANPRM also asked for comments on
other ways to reduce miners’ exposures,
such as increased awareness of potential
asbestos hazards at the mine site and the
provision of adequate protection. We
also asked for suggestions on what
educational and technical assistance
MSHA could provide and what other
factors, circumstances, or measures we
should consider when engineering
controls are unable to reduce asbestos
exposure below the PEL.
We received some criticism
concerning our sampling and analysis
procedures from a few commenters who
believed that we should develop
specific test procedures for the sampling
and analysis of bulk samples for the
mining environment, as well as specific
air sampling procedures (including
pump flow rates, cassette types, and
filter matrix). They also believed that we
should improve our reports by
including inspection field notes,
location, purpose, and procedure
followed, as well as descriptions of the
accuracy, meaning, and limitations of
the results. In its comments to the
ANPRM, one trade association
recommended that we maintain our
current, established asbestos monitoring
protocols with emphasis on full-shift
monitoring for comparison to the PEL.
Another trade association stated that our
current field sampling methods are
adequate for most mines and quarries,
particularly when no significant amount
of asbestos is found. They also
suggested that respirable dust sampling
using a cyclone might be a means to
remove interfering dust from the
sample. NIOSH suggested that we could
use thoracic samplers, but that studies
performed on their use did not include
mines and further positive test results
would be needed before they could
promote their use in mining.
We believe that our current sampling
procedures are adequate and we are
proposing to continue using them. Our
current procedures, which we updated
in 2000, specify using several, typically
three, 25-mm filter-cassettes in series to
collect a full-shift sample. Depending on
the amount of visible dust in the air,
these procedures allow the setting of
pump flow rates to optimize fiber
loading and minimize or eliminate
mixed dust overload. We are not
considering the use of a cyclone to
capture respirable dust because research
indicates that larger durable fibers also
could cause adverse health effects.
6. Bulk Sample Analysis Using
Polarized Light Microscopy (PLM)
In the ANPRM, we asked what
method was most appropriate for MSHA
to use to analyze bulk samples for
asbestos in the mining industry. The
presence of asbestos in a bulk sample
does not mean that it poses a hazard.
The asbestos must become airborne and
be respirable, or contaminate food or
water, to pose a health hazard to miners.
The detection of asbestos in a bulk
sample serves to alert mine operators,
miners, and MSHA to the possible
presence of asbestos. One mining
association stated that air monitoring is
not the preferred scheme to screen for
possible asbestos exposure. They
believe, and we agree, that knowledge of
the geology of asbestos and
identification of asbestos in bulk
samples may be a useful step in
determining whether asbestos is present
in the ore or host rock.
We are not proposing to use bulk
samples to determine asbestos
exposures in mining. We are requesting
comments on whether MSHA’s use of
routine, periodic bulk sampling would
be useful in determining whether or not
we should take personal exposure air
samples to evaluate miners’ exposures
to asbestos at mines suspected of having
naturally occurring asbestos.
MSHA also uses the detection of
asbestos in bulk samples as a trigger for
its compliance assistance activities. We
have trained MSHA inspectors on ways
to identify asbestos in the ore and
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surrounding rock formations at mines
and to pass this information on to mine
operators. Analysis of samples of
accumulated settled dust from a mill or
construction debris can identify areas or
activities that would require special
precautions. After considering the
results of the bulk sample analysis,
together with its strengths and
weaknesses, the mine operator, miners,
and MSHA can take appropriate action
to reduce the risk of exposure, which
would help reduce the risk of asbestosrelated diseases among miners.
Analysis of bulk samples is usually
performed using PLM. Commenters to
the ANPRM expressed concern that the
PLM analysis may not detect asbestos
when it is present. A particle must be
at least 0.5 µm in diameter to refract
light and many asbestos fibers are too
thin to refract light. Asbestos may be a
small percentage of the parent material
or not uniformly dispersed in the
sample and, therefore, may not be seen
in the small portion of sample that is
examined under the microscope. In
addition, the method could detect
asbestos erroneously because a
nonasbestiform mineral could have a
refractive index similar to one of the
asbestos minerals. Another problem
with identifying asbestos using PLM is
that all varieties of a mineral show the
same refractive index. For example,
even an experienced analyst might not
differentiate between the asbestiform
and nonasbestiform varieties of a
mineral based on their refractive
indices.
Although a trained individual may be
able to identify bulk asbestos by its
appearance and physical properties, the
identification can be more difficult
when the asbestos is dispersed in a dust
sample or is present in low
concentration in a rock. A commenter at
MSHA’s hearing in Charlottesville
(2002) testified that none of the existing
methods for bulk sample analysis (EPA,
NIOSH, ASTM) were designed for
complex mine environments.
D. Discussion of Asbestos Take-Home
Contamination
This proposed rule does not include
standards to address asbestos take-home
contamination. We recognize the
important role of take-home exposures
in contributing to asbestos disease of
workers and their family members. We
believe that a combination of
enforcement and compliance assistance
activities, together with increased
education and training of mine
inspectors, mine operators, and miners,
coupled with the lowering of the PELs,
would be effective in preventing
asbestos take-home contamination.
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Mine operators are encouraged to
measure the potential for take-home
contamination and provide protective
measures where necessary to minimize
secondary take-home exposures.
1. MSHA’s Request for Information
MSHA’s ANPRM for measuring and
controlling asbestos exposures at mines
included requests for information and
data to help us evaluate what we could
do to eliminate or minimize take-home
contamination. We asked how and/or
should MSHA be addressing take-home
contamination. We also asked about
provisions for the special needs of small
mine operators and what assistance
(e.g., step-by-step instructions, model
programs, certification of private
programs) we could provide. We also
requested information on the types of
protective clothing miners currently use
when working in areas where asbestos
may be present, and the types of
preventive measures currently in use
when miners leave the area, to prevent
the spread of asbestos exposure.
2. Commenters’ Responses to the TakeHome Contamination Issue in MSHA’s
Asbestos ANPRM
Commenters expressed concern that
we would apply the requirements in
OSHA’s and EPA’s standards to trace
levels of fibrous mineral exposures at
mines, pits, and quarries. Many industry
commenters urged MSHA to limit
protective measures for take-home
contamination to those activities
involving known asbestos and asbestoscontaining products, such as those
regulated by OSHA and EPA. For
example, commenters suggested that
MSHA adopt appropriate provisions
from the OSHA asbestos standard for
construction workers, for asbestos
abatement workers, and for those miners
whose exposures exceed MSHA’s PEL.
Commenters cautioned MSHA to be
mindful of the definitions of asbestos
when analyzing samples to determine
compliance. They also urged MSHA to
acknowledge the presence of
interferences in mining samples, as well
as the differences between
nonasbestiform amphiboles and their
asbestos analogues. Some commenters
cautioned that, unless MSHA
constructed the provisions for reducing
take-home contamination carefully, the
consequences for the mining industry
might be costly with little or no benefit
to miners.
NIOSH encouraged MSHA to adopt
measures included in its 1995 Report to
Congress on their Workers’ Home
Contamination Study Conducted under
the Workers’ Family Protection Act.
Labor participants also supported
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protective measures, such as personal
protective equipment and showers
before leaving work, to prevent takehome contamination.
3. MSHA’s Considerations in Making Its
Decision To Use Non-Regulatory
Methods To Address the Hazard From
Take-Home Contamination
In determining an appropriate
proposed action for preventing takehome contamination, we considered the
comments to the ANPRM, OSHA’s and
EPA’s requirements, and the
recommendations of NIOSH and the
OIG. We based our determination to
propose to address asbestos take-home
contamination through non-regulatory
measures on the following factors:
• Existing standards requiring
engineering controls for airborne
contaminants, respiratory protection,
personal protective clothing, hazard
communication, and housekeeping,
together with a lower PEL, would
provide sufficient enforcement authority
to assure that mine operators take
adequate measures when necessary to
prevent asbestos take-home
contamination.
• There are no asbestos mines or
mills currently operating in this country
and different ore bodies of the same
commodity, such as vermiculite mining,
are not consistent in the presence,
amount, or dispersion of asbestiform
minerals. Currently, asbestos exposures
in mining are low. As discussed in
section V.D.2 of this preamble, only two
of the 123 mines sampled for asbestos
in the ore show personal asbestos
exposures exceeding 0.1 f/cc. This is
less than 2 percent of the sampled
mines.
• Some mines with asbestos minerals
in the ore or host rock have
implemented protective measures
voluntarily. MSHA experience in the
recent past indicates that mine operators
and mining companies are increasingly
aware of asbestos hazards and have been
willing to cooperate with MSHA to
eliminate this hazard.
• The measures taken to prevent takehome contamination are varied, and
mine operators would have the freedom
to eliminate this hazard in a manner
based on site-specific exposure
measurements and the nature of the
asbestos exposures at the mine. For
example, mine operators could
minimize or prevent asbestos take-home
contamination by providing disposable
coveralls or on-site shower facilities
coupled with clothing changes.
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4. MSHA’s Activities for Eliminating the
Risk of Asbestos Take-Home
Contamination
We believe that mine operators and
miners would take action to eliminate
any possible recurrence of a disaster,
such as that in Libby, Montana, if they
understand the hazards and ways to
minimize the risk. To that end, we are
placing special emphasis on the
potential hazard from asbestos takehome contamination in our
enforcement, compliance assistance,
and educational activities as follows.
a. Enforcement Activities.
• Enforce the new, lower PELs when
they become effective.
• Continue enforcement of standards
applicable to providing special
protective equipment and clothing
whenever environmental hazards are
encountered in a manner capable of
causing injury or impairment, e.g.,
§ 56.15006.
• Ensure that mine operators provide
miners, who are at risk of being
exposed, with information about the
signs, symptoms, and risk for
developing asbestos-related illness as
required by the hazard communication
standard.
b. Compliance Assistance.
• Continue to monitor targeted mines
for the presence of asbestos.
• Encourage mine operators to
comply with OSHA’s asbestos standard,
or hire professionals skilled and
certified in working with asbestos, when
they engage in construction, demolition,
or renovation activities at the mine.
• Issue an updated Program
Information Bulletin (PIB) on asbestos to
include a greater emphasis on protective
measures to reduce take-home
contamination. We expect distribution
this year.
c. Educational Activities.
• Continue outreach to mine
operators through training courses,
informational materials, and topical
local meetings.
• Issue an updated Health Hazard
Information Card for miners this year to
increase miners’ awareness of the
hazards of take-home contamination
from asbestos or other asbestiform
minerals and to suggest measures that
the miners can take to prevent it.
• Continue specialized asbestos
hazard and sampling training for mine
inspectors.
E. Section 71.701(c) and (d): Sampling;
General Requirements [Controlling
Asbestos Exposures in Coal Mines]
For surface coal mines and surface
worksites at underground coal mines,
we are proposing to add a reference to
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§ 71.702 (the asbestos standard for coal
mines) in paragraphs (c) and (d) of
§ 71.701, which contain the
requirements for controls and sampling.
The existing language in § 71.701(c) and
(d) references the Threshold Limit
Values (TLVs) and excursion limits in
§ 71.700, but not the asbestos exposure
limits in § 71.702. MSHA regulations
currently require mine operators to
control miners’ exposures to airborne
contaminants and to sample for airborne
contaminants, as necessary, to
determine when and where such
controls may be needed. In developing
this proposed rule, we determined that
§ 71.701 was unclear as to its
applicability to asbestos exposures. This
proposed rule would clarify our intent
that coal mine operators control miners’
exposures to asbestos.
VIII. Regulatory Analyses
A. Executive Order (E.O.) 12866
In our ANPRM on asbestos exposure,
we specifically requested information,
data, and comments on the costs and
benefits of an asbestos rule, including
what engineering controls and personal
protective equipment are being used to
protect miners from exposure to
asbestos and to prevent take-home
contamination. Considering the public
comments, and MSHA data and
experience, we assessed both the costs
and benefits of this proposed rule in
accordance with Executive Order 12866.
The following sections summarize the
analysis of benefits and costs presented
in the Preliminary Regulatory Economic
Analysis (PREA) for this proposed rule.
The PREA contains a full disclosure of
our methodology and the basis for our
estimates.
1. Discussion of Benefits
The benefits of a rulemaking
addressing measurement and control of
asbestos would be the reduction or
elimination of diseases arising from
exposure to asbestos. Exposure to
airborne asbestos can cause the
development of lung cancer,
mesothelioma, gastrointestinal cancer,
and asbestosis. Other associated adverse
health effects include cancers of the
larynx, pharynx, and kidneys. A person
with an asbestos-related disease suffers
material impairment of health or
functional capacity.
a. Summary of Benefits.
We estimate that between 1 and 19
deaths could be avoided during the next
65 years by lowering the 8-hour TWA,
full-shift exposure limit from 2.0 f/cc to
0.1 f/cc. This equates to a reduction of
between 9 and 84 percent of
occupationally related deaths caused by
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asbestos exposures. Additional deaths
would be avoided by decreasing miners’
exposures to short-term bursts of
airborne asbestos undetectable by the
proposed 8-hour TWA, full-shift
exposure limit. We estimate that
lowering the excursion limit from 10 f/
cc over 15 minutes to 1 f/cc over 30
minutes would reduce the risk of death
from lung cancer, mesothelioma, or
gastrointestinal cancer by 1 additional
avoidable death for every 1,000 miners
exposed to asbestos at the proposed
PELs.
We are aware that lowering our PELs
would not completely eliminate the risk
of asbestos-related material impairment
of health or functional capacity. We
expect some additional risk reduction
from mine operators’ management
directives to avoid disturbing asbestos
on mine property.
b. Calculation of Deaths Avoided.
The benefits resulting from the
lowered PELs depend on several factors
including—
• Existing and projected exposure
levels,
• Age of the miner at first exposure,
• Number of workers exposed, and
• Risk associated with each exposure
level.
We estimate the number of miners
currently exposed and their level of
exposure from personal exposure
information gathered during our
inspections between January 2000 and
December 2003. These data are available
on our Web site at https://
www.msha.gov. Section V of this
preamble contains the characterization
and assessment of exposures in mining.
Laboratory results indicate that
exposure concentrations are unevenly
distributed across mines and miners.
We use four fiber concentration levels to
estimate the risk to miners. The break
points for these exposure levels are the
proposed and existing exposure limits.
Observations show that 90 percent of
the sampling results are below 0.1 f/cc.
To estimate the expected number of
asbestos-related deaths, we applied
OSHA’s linear, no-threshold, doseresponse risk assessment model to our
existing and proposed PELs. The upper
exposure limit is 10 f/cc because the
range of information derived from the
epidemiological studies used to
determine the dose-response
relationship in OSHA’s quantitative risk
assessment does not include higher
levels. The expected reduction of deaths
resulting from lowering the PELs would
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be the differences between the expected
deaths at each exposure level.87
OSHA estimated cancer mortality for
workers exposed to asbestos and
published these data in their 1986 final
rule (51 FR 22644). We discuss OSHA’s
asbestos risk assessment in section VI of
this preamble and have reproduced
OSHA’s mortality data in Table VI–4.
c. Benefit of the Proposed 0.1 f/cc 8hour TWA, Full-Shift Exposure Limit.
The current deaths from lung cancer,
mesotheliomas, gastrointestinal cancer,
and asbestosis are the result of past
exposures to much higher air
concentrations of asbestos than those
found in mines today. The risks of these
diseases still exist, however, and these
risks are significant for miners exposed
to lower air concentrations of asbestos.
Most diseases resulting from a current
asbestos exposure may not become
evident for another 20 to 30 years. Most
likely, the full benefits will occur over
a 65-year period following
implementation of the lower PELs. The
rate at which the incidence of the
cancers decreases depends on several
factors including—
• Latency of onset of cancer,
• Attrition of the mining workforce,
• Changing rates of competing causes
of death,
• Dynamics of other risk factors,
• Changes in life expectancy, and
• Advances in cancer treatments.
It is not possible to quantify accurately
the complete dynamics of this process.
Supplemental examination of
MSHA’s personal exposure samples
using TEM analysis indicates that not
all fibers counted by PCM are the
currently regulated asbestos minerals.
This is especially true for operations
mining and processing wollastonite. We
distinguish between different
mineralogical fibers using TEM and
87 Nicholson, 1983; JRB Associates, 1983; OSHA
(51 FR 22612), 1986; OSHA (53 FR 35609), 1988;
OSHA (59 FR 40964), 1994.
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combine this supplemental information
with PCM information to calculate our
lower estimate of benefits.
We estimate that there would be from
0.5 to 13.1 lung cancer deaths avoided,
0.2 to 4.4 mesothelioma deaths avoided,
and 0.1 to 1.3 gastrointestinal cancer
deaths avoided. The total number of
cancer deaths avoided by this rule
would be the sum of cancer deaths
avoided at all the mines included in the
exposure data, that is, the mines we
have sampled. Based on the best
available information, we expect a
reduction of between 1 and 19 deaths
avoided due to lowering the 8-hour
TWA PEL to 0.1 f/cc.
d. Benefits of the Proposed 1.0 f/cc
Excursion Limit.
We are proposing an asbestos
excursion limit of 1.0 f/cc as measured
over a 30-minute period for metal and
nonmetal miners and coal miners
working at surface work areas. We
intend that the excursion limit protect
miners from the adverse health risks
associated with brief fiber-releasing
episodes. We anticipate that some
mining operations will be subject to
brief fiber-releasing episodes even after
lowering airborne asbestos
concentrations to the 8-hour TWA, fullshift exposure limit. We have
insufficient data, however, to obtain a
meaningful estimate of the frequency of
these episodes, the actual exposure
concentrations, or the numbers of
miners exposed. Miners may encounter
brief fiber-releasing episodes from
exposure to commercial asbestos in
asbestos-containing building materials
(ACBM) or as settled dust containing
asbestos; while working on equipment
that may have asbestos-containing parts;
and while drilling, dozing, blasting, or
roof bolting in areas of naturally
occurring asbestos.
Because we have little information
from short-term exposure
measurements, we estimate the benefit
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of an excursion limit from the difference
in concentration between the 8-hour
TWA, full-shift exposure limit (0.1 f/cc)
and the excursion limit averaged over
the full shift [(1 f/cc)/(16 30-minute
periods) = 0.063 f/cc]. The lifetime risk
associated with an exposure to 0.1 f/cc
from either of the three types of cancer
is 0.00336, if first exposed at age 25 and
exposure continues every work day at
that level for a duration of 45 years. The
risk associated with exposure to 0.063
f/cc using the same age and duration of
exposure is 0.00212. The difference in
lifetime risk is 0.00124. This risk
equates to 1.24 additional deaths
avoided for every 1,000 miners exposed
to asbestos at a concentration afforded
by the proposed excursion limit.
e. Further Consideration of Benefits.
We believe that the pressure of public
scrutiny and government intervention
has prompted mine operators to take
precautionary measures to limit miners’
exposures to asbestos. If public
pressures were to subside, and we did
not have a regulation limiting exposures
to 0.1 f/cc over an 8-hour shift, we
would not have a means to enforce the
same level of protection provided in
other industries.
Enforcement of the lower PELs
together with the direct support from
the federal government in education,
identification, and elimination of the
asbestos hazard would increase
awareness and attention to the presence
of asbestos on mine property. These
activities also would help focus efforts
on preventing exposures, thus providing
miners with added health benefits. As
seen in Chart VIII–1, mining operations
with ore containing naturally occurring
asbestos seem to have reduced miners’
exposures, perhaps due to their
awareness of the lower exposure limits
OSHA promulgated in 1986.88
88 NIOSH
89 NIOSH
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WoRLD, 2003.
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The estimates of the cancer deaths
avoided by reducing the PELs
understate the total amount of benefit
gained from this rule. These benefits do
not include the reduced incidence of
asbestosis-related disabilities.
Asbestosis cases often lead to
tremendous societal costs in terms of
health care utilization, loss of worker
productivity, and a decrease in the
quality of life of the affected individual.
Similarly, MSHA’s analysis does not
quantify benefits among groups
incidentally exposed, such as miners’
family members. We note that several
published articles document and
discuss the health effects resulting from
exposure to asbestos incident to living
with a miner.90
This analysis overstates health
benefits to the extent that we do not
account for differential risks posed by
different types of fibers as identified by
PCM, and differences in the cancer
mortality risk for asbestos-exposed
workers who smoke and those who do
not.
2. Discussion of Costs
The proposed rule would result in
total yearly costs of about $136,100. The
43981
cost would be about $91,500 per year for
metal and nonmetal mines and about
$44,600 per year for coal mines. These
costs represent less than 0.001 percent
of the yearly revenues of $38.0 billion
for the metal and nonmetal mining
industry and $10.1 billion for the
surface coal mining industry.
Table VIII–1 presents our estimate of
the total yearly compliance costs by
compliance strategy and mine size. The
total costs reported are projected costs,
in 2002 dollars, based on our
knowledge, experience, and available
information.
TABLE VIII–1.—SUMMARY OF YEARLY COMPLIANCE COSTS
Compliance strategy
Metal and nonmetal mine size
Selective
mining
Wet methods
Mill ventilation
Removal of
introduced
asbetos
Total for metal
and nonmetal
mines
Small (<20) ..........................................................................
Large (20–500) ....................................................................
Large (>500) ........................................................................
$1,058
4,922
1,641
$1,235
8,614
2,871
$747
12,916
19,001
$1,750
21,000
15,750
$4,790
47,452
39,264
Total ..............................................................................
7,622
12,721
32,664
38,500
91,506
Compliance strategy
Selective
mining
Small (<20) ..........................................................................
Large (20–500) ....................................................................
Large (>500) ........................................................................
90 NIOSH
Wet methods
Mill ventilation
........................
........................
........................
........................
........................
........................
........................
........................
........................
Publication No. 2002–113, May 2002.
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Removal of
introduced
asbetos
$875
12,250
31,500
Total for coal
mines
$875
12,250
31,500
EP29JY05.005
Coal mine size
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Compliance strategy
Coal mine size
Selective
mining
Total ..............................................................................
B. Feasibility
MSHA has concluded that the
requirements of this proposed rule
would be both technologically and
economically feasible. This proposed
rule is not a technology-forcing standard
and does not involve activities on the
frontiers of scientific knowledge. All
devices that would be required by the
proposed rule are already available in
the marketplace and have been used in
either the United States or the
international mining community. We
have concluded, therefore, that this
proposed rule is technologically
feasible.
As previously estimated, the mining
industry would incur costs of about
$136,100 yearly to comply with this
proposed rule. These compliance costs
represent well less than 0.001 percent of
the yearly revenues of the mines
covered by this rule, thus providing
convincing evidence that the proposed
rule is economically feasible.
C. Alternatives Considered
In our discussion of PELs in section
VII.B of this preamble, we recognize that
there is a remaining residual risk of
adverse health effects for miners
exposed at the proposed asbestos 8-hour
TWA PEL. We considered proposing a
lower PEL as a regulatory alternative to
further reduce the risk of adverse health
effects from a working lifetime of
exposure. Assuming 0.05 f/cc, for
example, and interpolating the data
from OSHA’s risk assessment
summarized in Table VI–4 of this
preamble, there would be about 1.68
cancer deaths per 1,000 miners exposed
to asbestos at 0.05 f/cc for 45 years. The
1.68 cancer mortality rate is 50 percent
less than the rate of 3.36 cancer deaths
per 1,000 exposed miners calculated for
the proposed 0.1 f/cc PEL; and about 97
percent less than we estimate for our
existing standard (64.12 cancer deaths
per 1,000 exposed miners). We also
project that reducing miner’s exposure
to an 8-hour TWA of 0.05 f/cc would
reduce the expected cases of asbestosis
to about 50 percent less than at the
proposed 8-hour TWA PEL.
About 85 percent of the 123 sampled
mines are already well in compliance
with the 0.1 f/cc proposed PEL. We
believe that, theoretically, almost all of
the mining industry could be in
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Wet methods
Mill ventilation
........................
........................
........................
compliance with a lower alternative PEL
(0.05 f/cc 8-hour TWA). However, we
cannot enforce an 8-hour TWA limit
below 0.1 f/cc. The diversity of airborne
particles prevalent in mining
environments can interfere with sample
analysis. Our existing standardized
sampling techniques minimize
interferences, but also impose
limitations of accuracy below
concentrations of 0.1 f/cc. We address
these limitations in more detail in
Chapter III of the PREA that
accompanies this proposed rule. These
accuracy issues make it infeasible for us
to enforce a concentration lower than
0.1 f/cc airborne asbestos.
Although TEM provides greater
characterization of asbestos fibers than
PCM methodology, there is no
predictable relationship between PCM
and TEM measures of exposure using
either method alone. We do not know of
a risk assessment correlating TEM
measures of exposure with adverse
health effects. TEM measurements,
therefore, cannot be used as the basis for
an occupational exposure limit at this
time. Additionally, TEM is much more
expensive and time consuming than
PCM. If we were to analyze each of the
2,184 personal exposure filters
(collected by us to determine full-shift
asbestos exposures from 2000 through
2003) using TEM, rather than PCM, it
would cost us about $186,000 to
$852,000 more. The mine operator’s
costs would increase in so far as the
operator would do comparable
sampling. We expect the operator to
sample to determine whether control
measures are needed, what controls
might be needed, and the effectiveness
of controls when implemented. A
number of commenters supported our
continued use of PCM for the initial
analysis of asbestos samples.
We conclude that it is not feasible to
regulate the mining industry below the
proposed limit at this time. We welcome
comments on the exposure limit
proposed and the rationale used for
choosing it over the alternative
discussed above.
D. Regulatory Flexibility Analysis (RFA)
and Small Business Regulatory
Enforcement Fairness Act (SBREFA)
Based on our data, our experience,
and information submitted to the
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Removal of
introduced
asbetos
44,625
Total for coal
mines
44,625
record, we determined, and here certify,
that this proposed rule would not have
a significant economic impact on a
substantial number of small entities.
The PREA for this proposed rule (RIN:
1219–AB24), Measuring and Controlling
Asbestos Exposure, contains the factual
basis for this certification as well as
complete details about data, equations,
and methods used to calculate the costs
and quantified benefits. We have placed
the PREA in the rulemaking docket and
posted it on MSHA’s Web site at
https://www.msha.gov.
E. Other Regulatory Considerations
1. The National Environmental Policy
Act of 1969 (NEPA)
We have reviewed this proposed rule
in accordance with the requirements of
NEPA (42 U.S.C. 4321 et seq.), the
regulations of the Council on
Environmental Quality (40 CFR 1500),
and the Department of Labor’s NEPA
procedures (29 CFR 11) and have
assessed its environmental impacts. We
found that this proposed rule would
have no significant impact on air, water,
or soil quality; plant or animal life; the
use of land; or other aspects of the
human environment.
2. Paperwork Reduction Act of 1995
This proposed rule contains no
information collection or recordkeeping
requirements. Thus, there are no
additional paperwork burden hours and
related costs associated with the
proposed rule. Accordingly, the
Paperwork Reduction Act requires no
further agency action or analysis.
3. The Unfunded Mandates Reform Act
of 1995
This proposed rule does not include
any Federal mandate that may result in
increased expenditures by State, local,
or tribal governments; nor would it
significantly or uniquely affect small
governments. It would not increase
private sector expenditures by more
than $100 million annually.
Accordingly, the Unfunded Mandates
Reform Act requires no further agency
action or analysis.
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4. Treasury and General Government
Appropriations Act of 1999, (Section
654: Assessment of Impact of Federal
Regulations and Policies on Families)
This proposed rule would have no
affect on family well-being or stability,
marital commitment, parental rights or
authority, or income or poverty of
families and children. Accordingly, the
Treasury and General Government
Appropriations Act requires no further
agency action, analysis, or assessment.
5. Executive Order 12630: Government
Actions and Interference With
Constitutionally Protected Property
Rights
This proposed rule would not
implement a policy with takings
implications. Accordingly, Executive
Order 12630 requires no further agency
action or analysis.
6. Executive Order 12988: Civil Justice
Reform
We have drafted and reviewed this
proposed rule in accordance with
Executive Order 12988. We wrote this
proposed rule to provide a clear legal
standard for affected conduct and
carefully reviewed it to eliminate
drafting errors and ambiguities, thus
minimizing litigation and undue burden
on the Federal court system. MSHA has
determined that this proposed rule
would meet the applicable standards in
section 3 of Executive Order 12988.
7. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
This proposed rule would have no
adverse impact on children. This
proposed asbestos standard might
benefit children by reducing
occupational exposure limits, thus
reducing their risk of disease from takehome contamination. Accordingly,
Executive Order 13045 requires no
further agency action or analysis.
8. Executive Order 13132: Federalism
This proposed rule would not have
‘‘federalism implications,’’ because it
would not ‘‘have substantial direct
effects 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.’’
Accordingly, Executive Order 13132
requires no further agency action or
analysis.
9. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This proposed rule would not have
‘‘tribal implications,’’ because it would
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not ‘‘have substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
government and Indian tribes.’’
Accordingly, Executive Order 13175
requires no further agency action or
analysis.
10. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
In accordance with Executive Order
13211, we have reviewed this proposed
rule for its impact on the supply,
distribution, and use of energy. This
proposed rule would regulate both the
coal and metal and nonmetal mining
sectors. Because this proposed rule
would result in negligible yearly costs of
less than 0.001 percent of revenues to
the coal mining industry, the proposed
rule would neither significantly reduce
the supply of coal nor significantly
increase its price. Regulation of the
metal and nonmetal sector of the mining
industry has no significant impact on
the supply, distribution, or use of
energy.
This proposed rule is not a
‘‘significant energy action,’’ because it
would not be ‘‘likely to have a
significant adverse effect on the supply,
distribution, or use of energy’’
‘‘(including a shortfall in supply, price
increases, and increased use of foreign
supplies).’’ Accordingly, Executive
Order 13211 requires no further agency
action or analysis.
11. Executive Order 13272: Proper
Consideration of Small Entities in
Agency Rulemaking
In accordance with Executive Order
13272, we have thoroughly reviewed
this proposed rule to assess and take
appropriate account of its potential
impact on small businesses, small
governmental jurisdictions, and small
organizations. As discussed in section
VIII.C. above and in chapter V of the
PREA, MSHA has determined and
certified that this proposed rule would
not have a significant economic impact
on a substantial number of small
entities.
IX. Copy of the OSHA Reference
Method (ORM)
MSHA’s existing asbestos standards
require that the analyst determine fiber
concentrations using a phase contrast
microscopy analytical method with
400–450X magnification and count
fibers 5 µm or longer having a length to
diameter aspect ratio of at least 3:1. The
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OSHA Reference Method contains these
requirements.
29 CFR 1910.1001 Appendix A: OSHA
Reference Method—Mandatory
This mandatory appendix specifies the
procedure for analyzing air samples for
asbestos and specifies quality control
procedures that must be implemented by
laboratories performing the analysis. The
sampling and analytical methods described
below represent the elements of the available
monitoring methods (such as Appendix B of
their regulation, the most current version of
the OSHA method ID–160, or the most
current version of the NIOSH Method 7400).
All employers who are required to conduct
air monitoring under paragraph (d) of the
[OSHA] standard are required to utilize
analytical laboratories that use this
procedure, or an equivalent method, for
collecting and analyzing samples.
Sampling and Analytical Procedure
1. The sampling medium for air samples
shall be mixed cellulose ester filter
membranes. These shall be designated by the
manufacturer as suitable for asbestos
counting. See below for rejection of blanks.
2. The preferred collection device shall be
the 25-mm diameter cassette with an openfaced 50-mm electrically conductive
extension cowl. The 37-mm cassette may be
used if necessary but only if written
justification for the need to use the 37-mm
filter cassette accompanies the sample results
in the employee’s exposure monitoring
record. Do not reuse or reload cassettes for
asbestos sample collection.
3. An air flow rate between 0.5 liter/min
and 2.5 liters/min shall be selected for the
25-mm cassette. If the 37-mm cassette is
used, an air flow rate between 1 liter/min and
2.5 liters/min shall be selected.
4. Where possible, a sufficient air volume
for each air sample shall be collected to yield
between 100 and 1,300 fibers per square
millimeter on the membrane filter. If a filter
darkens in appearance or if loose dust is seen
on the filter, a second sample shall be started.
5. Ship the samples in a rigid container
with sufficient packing material to prevent
dislodging the collected fibers. Packing
material that has a high electrostatic charge
on its surface (e.g., expanded polystyrene)
cannot be used because such material can
cause loss of fibers to the sides of the
cassette.
6. Calibrate each personal sampling pump
before and after use with a representative
filter cassette installed between the pump
and the calibration devices.
7. Personal samples shall be taken in the
‘‘breathing zone’’ of the employee (i.e.,
attached to or near the collar or lapel near the
worker’s face).
8. Fiber counts shall be made by positive
phase contrast using a microscope with an 8
to 10 X eyepiece and a 40 to 45 X objective
for a total magnification of approximately
400 X and a numerical aperture of 0.65 to
0.75. The microscope shall also be fitted with
a green or blue filter.
9. The microscope shall be fitted with a
Walton-Beckett eyepiece graticule calibrated
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for a field diameter of 100 micrometers (+/
¥2 micrometers).
10. The phase-shift detection limit of the
microscope shall be about 3 degrees
measured using the HSE phase shift test slide
as outlined below.
a. Place the test slide on the microscope
stage and center it under the phase objective.
b. Bring the blocks of grooved lines into
focus.
Note: The slide consists of seven sets of
grooved lines (ca. 20 grooves to each block)
in descending order of visibility from sets 1
to 7, seven being the least visible. The
requirements for asbestos counting are that
the microscope optics must resolve the
grooved lines in set 3 completely, although
they may appear somewhat faint, and that the
grooved lines in sets 6 and 7 must be
invisible. Sets 4 and 5 must be at least
partially visible but may vary slightly in
visibility between microscopes. A
microscope that fails to meet these
requirements has either too low or too high
a resolution to be used for asbestos counting.
c. If the image deteriorates, clean and
adjust the microscope optics. If the problem
persists, consult the microscope
manufacturer.
11. Each set of samples taken will include
10 percent blanks or a minimum of 2 field
blanks. These blanks must come from the
same lot as the filters used for sample
collection. The field blank results shall be
averaged and subtracted from the analytical
results before reporting. A set consists of any
sample or group of samples for which an
evaluation for this standard must be made.
Any samples represented by a field blank
having a fiber count in excess of the
detection limit of the method being used
shall be rejected.
12. The samples shall be mounted by the
acetone/triacetin method or a method with
an equivalent index of refraction and similar
clarity.
13. Observe the following counting rules.
a. Count only fibers equal to or longer than
5 micrometers. Measure the length of curved
fibers along the curve.
b. In the absence of other information,
count all particles as asbestos that have a
length-to-width ratio (aspect ratio) of 3:1 or
greater.
c. Fibers lying entirely within the
boundary of the Walton-Beckett graticule
field shall receive a count of 1. Fibers
crossing the boundary once, having one end
within the circle, shall receive the count of
one half (1⁄2). Do not count any fiber that
crosses the graticule boundary more than
once. Reject and do not count any other
fibers even though they may be visible
outside the graticule area.
d. Count bundles of fibers as one fiber
unless individual fibers can be identified by
observing both ends of an individual fiber.
e. Count enough graticule fields to yield
100 fibers. Count a minimum of 20 fields;
stop counting at 100 fields regardless of fiber
count.
14. Blind recounts shall be conducted at
the rate of 10 percent.
Quality Control Procedures
1. Intralaboratory program. Each laboratory
and/or each company with more than one
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microscopist counting slides shall establish a
statistically designed quality assurance
program involving blind recounts and
comparisons between microscopists to
monitor the variability of counting by each
microscopist and between microscopists. In a
company with more than one laboratory, the
program shall include all laboratories and
shall also evaluate the laboratory-tolaboratory variability.
2.a. Interlaboratory program. Each
laboratory analyzing asbestos samples for
compliance determination shall implement
an interlaboratory quality assurance program
that as a minimum includes participation of
at least two other independent laboratories.
Each laboratory shall participate in round
robin testing at least once every 6 months
with at least all the other laboratories in its
interlaboratory quality assurance group. Each
laboratory shall submit slides typical of its
own work load for use in this program. The
round robin shall be designed and results
analyzed using appropriate statistical
methodology.
2.b. All laboratories should also participate
in a national sample testing scheme such as
the Proficiency Analytical Testing Program
(PAT), or the Asbestos Registry sponsored by
the American Industrial Hygiene Association
(AIHA).
3. All individuals performing asbestos
analysis must have taken the NIOSH course
for sampling and evaluating airborne asbestos
dust or an equivalent course.
4. When the use of different microscopes
contributes to differences between counters
and laboratories, the effect of the different
microscope shall be evaluated and the
microscope shall be replaced, as necessary.
5. Current results of these quality
assurance programs shall be posted in each
laboratory to keep the microscopists
informed.
[57 FR 24330, June 8, 1992; 59 FR 40964,
Aug. 10, 1994]
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List of Subjects
30 CFR Parts 56 and 57
Air quality, Asbestos, Chemicals,
Hazardous substances, Metals, Mine
safety and health.
30 CFR Part 71
Air quality, Asbestos, Chemicals, Coal
mining, Hazardous substances, Mine
safety and health.
Dated: July 14, 2005.
David G. Dye,
Deputy Assistant Secretary of Labor for Mine
Safety and Health.
For the reasons set out in the
preamble, and under the authority of the
Federal Mine Safety and Health Act of
1977, we are proposing to amend
chapter I of title 30 of the Code of
Federal Regulations as follows.
PART 56—[AMENDED]
1. The authority citation for part 56
would continue to read as follows:
Authority: 30 U.S.C. 811.
2. Section 56.5001 would be amended
by revising paragraph (b) to read as
follows:
§ 56.5001 Exposure limits for airborne
contaminants.
*
*
*
*
*
(b) Asbestos standard. (1) Definitions.
Asbestos is a generic term for a number
of hydrated silicates that, when crushed
or processed, separate into flexible
fibers made up of fibrils. As used in this
part—
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Asbestos means chrysotile, amosite
(cummingtonite-grunerite asbestos),
crocidolite, anthophylite asbestos,
tremolite asbestos, and actinolite
asbestos.
Fiber means a particulate form of
asbestos 5 micrometers (µm) or longer
with a length-to-diameter ratio of at
least 3–to–1.
(2) Permissible Exposure Limits
(PELs).
(i) Full-shift exposure limit. A miner’s
personal exposure to asbestos shall not
exceed an 8-hour time-weighted
average, full-shift airborne
concentration of 0.1 fibers per cubic
centimeter of air (f/cc).
(ii) Excursion limit. No miner shall be
exposed at any time to airborne
concentrations of asbestos in excess of
1.0 fiber per cubic centimeter of air
(f/cc) as averaged over a sampling
period of 30 minutes.
(3) Measurement of airborne fiber
concentration. Fiber concentration shall
be determined by phase contrast
microscopy using a method statistically
equivalent to the OSHA Reference
Method in OSHA’s asbestos standard
found in 29 CFR 1910.1001, appendix
A.
*
*
*
*
*
PART 57—[AMENDED]
3. The authority citation for part 57
would continue to read as follows:
Authority: 30 U.S.C. 811.
4. Section 57.5001 would be amended
by revising paragraph (b) to read as
follows:
§ 57.5001 Exposure limits for airborne
contaminants.
*
*
*
*
*
(b) Asbestos standard. (1) Definitions.
Asbestos is a generic term for a number
of hydrated silicates that, when crushed
or processed, separate into flexible
fibers made up of fibrils. As used in this
part—
Asbestos means chrysotile, amosite
(cummingtonite-grunerite asbestos),
crocidolite, anthophylite asbestos,
tremolite asbestos, and actinolite
asbestos.
Fiber means a particulate form of
asbestos 5 micrometers (µm) or longer
with a length-to-diameter ratio of at
least 3–to–1.
(2) Permissible Exposure Limits
(PELs).
(i) Full-shift exposure limit. A miner’s
personal exposure to asbestos shall not
exceed an 8-hour time-weighted
average, full-shift airborne
concentration of 0.1 fibers per cubic
centimeter of air (f/cc).
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(ii) Excursion limit. No miner shall be
exposed at any time to airborne
concentrations of asbestos in excess of
1.0 fiber per cubic centimeter of air
(f/cc) as averaged over a sampling
period of 30 minutes.
(3) Measurement of airborne fiber
concentration. Fiber concentration shall
be determined by phase contrast
microscopy using a method statistically
equivalent to the OSHA Reference
Method in OSHA’s asbestos standard
found in 29 CFR 1910.1001, appendix
A.
*
*
*
*
*
PART 71—[AMENDED]
5. The authority citation for part 71
would be revised to read as follows:
Authority: 30 U.S.C. 811, 951, 957.
6. Section 71.701 would be amended
by revising paragraphs (c) and (d) to
read as follows:
§ 71.701
Sampling; general requirements.
*
*
*
*
*
(c) Where concentrations of airborne
contaminants in excess of the applicable
threshold limit values, permissible
exposure limits, or permissible
excursions are known by the operator to
exist in a surface installation or at a
surface worksite, the operator shall
immediately provide necessary control
measures to assure compliance with
§ 71.700 or § 71.702, as applicable.
(d) Where the operator has reasonable
grounds to believe that concentrations
of airborne contaminants in excess of
the applicable threshold limit values,
permissible exposure limits, or
permissible excursions exist, or are
likely to exist, the operator shall
promptly conduct appropriate air
sampling tests to determine the
concentration of any airborne
contaminant which may be present and
immediately provide the necessary
control measures to assure compliance
with § 71.700 or § 71.702, as applicable.
7. Section 71.702 would be revised to
read as follows:
§ 71.702
Asbestos standard.
(a) Definitions. Asbestos is a generic
term for a number of hydrated silicates
that, when crushed or processed,
separate into flexible fibers made up of
fibrils. As used in this part—
Asbestos means chrysotile, amosite
(cummingtonite-grunerite asbestos),
crocidolite, anthophylite asbestos,
tremolite asbestos, and actinolite
asbestos.
Fiber means a particulate form of
asbestos 5 micrometers (µm) or longer
with a length-to-diameter ratio of at
least 3–to–1.
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(b) Permissible Exposure Limits
(PELs). (1) Full-shift exposure limit. A
miner’s personal exposure to asbestos
shall not exceed an 8-hour timeweighted average, full-shift airborne
concentration of 0.1 fibers per cubic
centimeter of air (f/cc).
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(2) Excursion limit. No miner shall be
exposed at any time to airborne
concentrations of asbestos in excess of
1.0 fiber per cubic centimeter of air
(f/cc) as averaged over a sampling
period of 30 minutes.
(c) Measurement of airborne fiber
concentration. Fiber concentration shall
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be determined by phase contrast
microscopy using a method statistically
equivalent to the OSHA Reference
Method in OSHA’s asbestos standard
found in 29 CFR 1910.1001, appendix
A.
[FR Doc. 05–14510 Filed 7–28–05; 8:45 am]
BILLING CODE 4510–43–P
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Agencies
[Federal Register Volume 70, Number 145 (Friday, July 29, 2005)]
[Proposed Rules]
[Pages 43950-43989]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14510]
[[Page 43949]]
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Part II
Department of Labor
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Mine Safety and Health Administration
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30 CFR Parts 56, 57, and 71
Asbestos Exposure Limit; Proposed Rule
Federal Register / Vol. 70, No. 145 / Friday, July 29, 2005 /
Proposed Rules
[[Page 43950]]
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DEPARTMENT OF LABOR
Mine Safety and Health Administration
30 CFR Parts 56, 57, and 71
RIN: 1219-AB24
Asbestos Exposure Limit
AGENCY: Mine Safety and Health Administration (MSHA), Labor.
ACTION: Proposed rule; notice of public hearings.
-----------------------------------------------------------------------
SUMMARY: We (MSHA) are proposing to revise our existing health
standards for asbestos exposure at metal and nonmetal mines, surface
coal mines, and surface areas of underground coal mines. The proposed
rule would reduce the full-shift permissible exposure limit and the
excursion limit for airborne asbestos fibers, and make several
nonsubstantive changes to add clarity to the standard. Exposure to
asbestos has been associated with lung and other cancers,
mesotheliomas, and asbestosis. This proposed rule would help assure
that fewer miners who work in an environment where asbestos is present
would suffer material impairment of health or functional capacity over
their working lifetime.
DATES: We must receive your comments on or before September 20, 2005.
We will hold public hearings on October 18 and 20. Details about the
public hearings are in the SUPPLEMENTARY INFORMATION section of this
preamble.
ADDRESSES: (1) To submit comments, please include ``RIN: 1219-AB24'' in
the subject line of the message and send them to us at either of the
following addresses.
Federal e-Rulemaking portal: Go to https://
www.regulations.gov and follow the online instructions for submitting
comments.
E-mail: zzMSHA-comments@dol.gov. If you are unable to
submit comments electronically, please identify them by ``RIN: 1219-
AB24'' and send them to us by any of the following methods.
Fax: 202-693-9441.
Mail, hand delivery, or courier: MSHA, Office of
Standards, Regulations, and Variances, 1100 Wilson Blvd., Rm. 2350,
Arlington, VA 22209-3939.
(2) We will post all comments on the Internet without change,
including any personal information they may contain. You may access the
rulemaking docket via the Internet at https://www.msha.gov/regsinfo.htm
or in person at MSHA's public reading room at 1100 Wilson Blvd., Rm.
2349, Arlington, VA.
(3) To receive an e-mail notification when we publish rulemaking
documents in the Federal Register, subscribe to our list serve at
https://www.msha.gov/subscriptions/subscribe.aspx.
FOR FURTHER INFORMATION CONTACT: Rebecca J. Smith at 202-693-9440
(Voice), 202-693-9441 (Fax), or mailto:smith.rebecca@dol.gov (E-mail).
SUPPLEMENTARY INFORMATION:
I. Introduction
A. Outline of Preamble
We are including the following outline to help you find information
in this preamble more quickly.
I. Introduction
A. Outline of Preamble
B. Dates and Locations for Public Hearings
C. Executive Summary
D. Abbreviations and Acronyms
II. Background
A. Scope of Proposed Rule
B. Where Asbestos Is Found at Mining Operations
C. Asbestos Minerals
III. History of Asbestos Regulation
A. MSHA's Asbestos Standards for Mining
B. OSHA's Asbestos Standards for General Industry and
Construction
C. Other Federal Agencies Regulating Asbestos
D. Other Asbestos-Related Activities
E. U.S. Department of Labor, Office of the Inspector General
(OIG)
IV. Health Effects of Asbestos Exposure
A. Summary of Asbestos Health Hazards
B. Factors Affecting the Occurrence and Severity of Disease
C. Specific Human Health Effects
D. Support from Toxicological Studies of Human Health Effects of
Asbestos Exposure
V. Characterization and Assessment of Exposures in Mining
A. Determining Asbestos Exposures in Mining
B. Exposures from Naturally Occurring Asbestos
C. Exposures from Introduced (Commercial) Asbestos
D. Sampling Data and Exposure Calculations
VI. The Application of OSHA's Risk Assessment to Mining
A. Summary of Studies Used by OSHA in Its Risk Assessment
B. Models Selected by OSHA (1986) for Specified Endpoints and
for the Determination of Its PEL and STEL
C. OSHA's Selection of Its PEL (0.1 f/cc)
D. Applicability of OSHA's Risk Assessment to the Mining
Industry
E. Significance of Risk
VII. Section-by-Section Discussion of Proposed Rule
A. Sections 56/57.5001(b)(1) and 71.702(a): Definitions
B. Sections 56/57.5001(b)(2) and 71.702(b): Permissible Exposure
Limits (PELs)
C. Sections 56/57.5001(b)(3) and 71.702(c): Measurement of
Airborne Fiber Concentration
D. Discussion of Asbestos Take-Home Contamination
E. Section 71.701(c) and (d): Sampling; General Requirements
VIII. Regulatory Analyses
A. Executive Order (E.O.) 12866
B. Feasibility
C. Alternatives Considered
D. Regulatory Flexibility Analysis (RFA) and Small Business
Regulatory Enforcement Fairness Act (SBREFA)
E. Other Regulatory Considerations
IX. Copy of the OSHA Reference Method (ORM)
X. References Cited in the Preamble
B. Dates and Locations for Public Hearings
We will hold two public hearings. If you wish to make a statement
for the record, please submit your request to us at least 5 days prior
to the hearing dates by one of the methods listed in the ADDRESSES
section above. The hearings will begin at 9 a.m. with an opening
statement from MSHA, followed by statements or presentations from the
public, and end after the last speaker (in any event not later than 5
p.m.) on the following dates at the locations indicated:
October 18, 2005, Denver Federal Center, Sixth and Kipling, Second
Street, Building 25, Denver, Colorado 80225, Phone: 303-231-5412.
October 20, 2005, Mine Safety and Health Administration, 1100 Wilson
Boulevard, Room 2539, Arlington, Virginia 22209, Phone: 202-693-9457.
We will hear scheduled speakers first, in the order that they sign
in; however, you do not have to make a written request to speak. To the
extent time is available, we will hear from persons making same-day
requests. The presiding official may exercise discretion to ensure the
orderly progress of the hearing by limiting the time allocated to each
speaker for their presentation.
The hearings will be conducted in an informal manner. Although
formal rules of evidence or cross examination will not apply, the
hearing panel may ask questions of speakers and a verbatim transcript
of the proceedings will be prepared and made a part of the rulemaking
record. We also will post the transcript on MSHA's Home Page at https://
www.msha.gov, on the Asbestos Single Source Page.
Speakers and other attendees may present information to the MSHA
panel for inclusion in the rulemaking record. We will accept written
comments and data for the record from any interested party, including
those not presenting oral statements. The post-hearing comment period
will close on November 21, 2005, 30 days after the last public hearing.
[[Page 43951]]
C. Executive Summary
In March of 2001, the U.S. Department of Labor, Office of the
Inspector General (OIG) published a report evaluating MSHA's
enforcement actions at the vermiculite mine in Libby, Montana. The
widespread asbestos contamination at this mine and surrounding
community, together with the prevalence of asbestos-related illnesses
and fatalities among persons living in this community, attracted press
and public attention, which prompted the OIG investigation and report.
The OIG found that MSHA had conducted regular inspections and personal
exposure sampling at the mine, as required by the Federal Mine Safety
and Health Act of 1977 (Mine Act). The OIG report stated, ``We do not
believe that more inspections or sampling would have prevented the
current situation in Libby.'' The OIG made five recommendations to
MSHA; two of which we implemented immediately. The remaining
recommendations are listed below:
Lower the existing permissible exposure limit (PEL) for
asbestos to a more protective level.
Use transmission electron microscopy (TEM) instead of
phase contrast microscopy (PCM) in the initial analysis of fiber
samples that may contain asbestos.
Implement special safety requirements to address take-home
contamination.
In response to the OIG's recommendations, MSHA published an advance
notice of proposed rulemaking (ANPRM) on March 29, 2002 (67 FR 15134).
MSHA also held seven public meetings around the country to seek input
and obtain public comment on how best to protect miners from exposure
to asbestos.
Following review of all public comments and testimony taken at the
public meetings, and relying on OSHA's 1986 asbestos risk assessment,
we determined that it is appropriate to propose reducing the PELs for
asbestos and clarify criteria for asbestos sample analysis. To enhance
the health and safety of miners, we are proposing to lower the existing
8-hour, time-weighted average (TWA) PEL of 2.0 f/cc to 0.1 f/cc, and to
lower the short-term limit from 10.0 f/cc over a minimum sampling time
of 15 minutes to an excursion limit PEL of 1.0 f/cc over a minimum
sampling time of 30 minutes. To clarify the criteria for the analytical
method in our existing standards, we are proposing to incorporate a
reference to Appendix A of OSHA's asbestos standard (29 CFR 1910.1001).
Appendix A specifies basic elements of a PCM method for analyzing
airborne asbestos samples. It includes the same analytical elements
specified in our existing standards and allows MSHA's use of other
methods that meet the statistical equivalency criteria in OSHA's
asbestos standard.
The scope of this proposed rule, therefore, is limited to lowering
the permissible exposure limits, an issue raised by the OIG;
incorporating Appendix A of OSHA's asbestos standard for the analysis
of our asbestos samples; and making several nonsubstantive conforming
amendments to our existing rule language. After considering several
regulatory approaches to prevent take-home contamination, we determined
that non-regulatory measures could adequately address this potential
hazard.
D. Abbreviations and Acronyms
As a quick reference, we list below some of the abbreviations used
in the preamble.
29 CFR Title 29, Code of Federal Regulations
30 CFR Title 30, Code of Federal Regulations
AFL-CIO American Federation of Labor and Congress of Industrial
Organizations
ATSDR Agency for Toxic Substances and Disease Registry, Centers for
Disease Control and Prevention, U.S. Department of Health and Human
Services
Bureau former Bureau of Mines, U.S. Department of the Interior
cc cubic centimeter (cm3) = milliliter (mL)
EPA U.S. Environmental Protection Agency
f fiber(s)
FR Federal Register
Lpm liter(s) per minute
MESA former Mining Enforcement and Safety Administration, U.S.
Department of the Interior (predecessor to MSHA)
MSHA Mine Safety and Health Administration, U.S. Department of Labor
mm millimeter = 1 thousandth of a meter (0.001 m)
mL milliliter = 1 thousandth of a liter (0.001 L) = cubic centimeter
NIOSH National Institute for Occupational Safety and Health, Centers
for Disease Control and Prevention, U.S. Department of Health and
Human Services
OIG Office of the Inspector General, U.S. Department of Labor
OSHA Occupational Safety and Health Administration, U.S. Department
of Labor
PCM phase contrast microscopy
PEL permissible exposure limit
PLM polarized light microscopy
STEL short-term exposure limit
SWA shift-weighted average concentration
TEM transmission electron microscopy
TWA time-weighted average concentration
[mu]m micron = micrometer = 1 millionth of a meter (0.000001 m)
USGS U.S. Geological Survey, U.S. Department of the Interior
II. Background
A. Scope of Proposed Rule
This proposed rule would apply to metal and nonmetal mines, surface
coal mines, and the surface areas of underground coal mines. Because
asbestos from any source poses a health hazard to miners if they inhale
it, the proposed rule would cover all miners exposed to asbestos
whether naturally occurring or contained in building materials, in
other manufactured products at the mine, or in mine waste or tailings.
The National Institute for Occupational Safety and Health (NIOSH)
and other research organizations and scientists (see Table VI-5) have
observed the occurrence of cancers and asbestosis among metal and
nonmetal miners involved in the mining and milling of commodities that
contain asbestos. For this reason, our primary focus at metal and
nonmetal mines is on asbestos in pockets or veins of mined commodities.
Historically, there has been no evidence of coal miners encountering
naturally occurring asbestos.\1\ The more likely exposure to asbestos
in coal mining would occur from introduced asbestos-containing
products, such as asbestos-containing building materials (ACBM) in
surface structures.
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\1\ Personal communication with Professor Kot Unrug, Department
of Mining Engineering, University of Kentucky, on November 14, 2003;
and with Syd S. Peng, Chairman, Department of Mining Engineering,
College of Engineering and Mineral Resources, West Virginia
University, the week of October 24, 2003.
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In 2000, the OIG investigated MSHA's activities at the vermiculite
mine in Libby, Montana. The OIG's conclusions and recommendations,
discussed later, are consistent with MSHA's observations and concerns
that--
Miners are exposed to asbestos at mining operations where
the ore body or surrounding rock contains asbestos;
Miners are potentially exposed to airborne asbestos at
mine facilities with installed asbestos-containing material when it is
disturbed during maintenance, construction, renovation, or demolition
activities; and
Family and community are potentially exposed if miners
take asbestos home on their person, clothes, or equipment, or in their
vehicle.
We developed this proposed rule based on our experience with
asbestos, our assessment of the health risks, the OIG's
recommendations, and public comments on MSHA's ANPRM addressing the
OIG's recommendations. We received numerous comments in response to the
ANPRM and at the
[[Page 43952]]
public meetings, some of which suggested or supported additional
requirements beyond those addressed by the OIG. We believe that the
comments to the ANPRM do not justify an expansion of the scope, at this
time, beyond the recommendations specifically raised in the OIG report.
On the contrary, we believe that our data support a narrowed scope
in that we specifically are not proposing two of the OIG's
recommendations, i.e., routine use of TEM for the initial analysis of
exposure samples and promulgation of standards to prevent take-home
contamination. We are proposing, however, to lower our permissible
exposure limits.
We have decided not to propose to change our existing definition of
asbestos in this rulemaking. There are several reasons for this.
First, this rulemaking is limited in scope. We believe that a 20-
fold lowering of the exposure limits, as we have proposed, together
with our enhanced measures to educate the mining community about the
asbestos hazard in mining, would increase protection for miners and
help avoid the future development of situations such as that in Libby,
Montana.
Second, interest in the definition of asbestos extends to numerous
agencies in Federal, state, and local governments. Our existing
definition is consistent with several Federal agencies' regulatory
provisions, including OSHA's. Changing the definition would require
considerable interagency consultation and coordination; additional
scientific evaluation; and an unnecessary delay in providing miners
access to the benefits of this proposed rule.
Third, we believe another Libby-like mining operation would not
exist today because such a business arguably would not be economically
viable. If a mine's ore contained significant amounts of asbestos-like
minerals, there is a strong likelihood of potential liability risks,
both from customers and workers, and the possibility that the mine's
product would be commercially unmarketable. Such market forces are
likely to compel mining companies of all sizes to sample the ore for
the presence of hazardous fibrous minerals before purchasing or
developing a mine site. In our view, these commercial reasons make it
unlikely that a new Libby-like mining condition would arise in the
future.
B. Where Asbestos Is Found at Mining Operations
Asbestos is no longer mined as a commodity in the United States.
Even so, veins, pockets, or intrusions of asbestos have been found in
other ores in specific geographic regions, primarily in metamorphic or
igneous rock.\2\ Although less common, it is not impossible to find
asbestos in sedimentary rock, soil, and air from the weathering or
abrasion of other asbestos-bearing rock.\3\ The areas where asbestos
may be located can be determined from an understanding of the
mineralogy of asbestos and the geology required for its formation. In
some cases, visual inspection can detect the presence of asbestos. MSHA
experience indicates that miners may encounter asbestos during the
mining of a number of mineral commodities,\4\ such as talc, limestone
and dolomite, vermiculite, wollastonite, banded ironstone and taconite,
lizardite, and antigorite. Not all mines of a specific commodity
contain asbestos in the ore, however, and the mines that do have
asbestos in the ore may encounter it rarely.
---------------------------------------------------------------------------
\2\ MSHA (Bank), 1980.
\3\ USGS, 1995.
\4\ Roggli et al., 2002; Selden et al., 2001; Amandus et al.,
Part I, 1987; Amandus et al., Part III, 1987; Amandus and Wheeler,
Part II, 1987.
---------------------------------------------------------------------------
Asbestos also is contained in building materials and other
manufactured products found at mines. Contrary to the common public
perception, asbestos is not banned in the United States.\5\ The U.S.
Geological Survey (USGS) estimates that about 13,000 metric tons (29
million pounds) of asbestos were used in product manufacturing in the
United States during 2001.\6\ In addition to domestic manufacturing,
the United States continues to import products that contain asbestos.
Asbestos may be used for a number of purposes at a mine including
insulation; reinforcement of cements; reinforcement of floor, wall, and
building tile; and automotive clutch and brake linings.\7\ If asbestos
is present at the mine, miners in the vicinity are potentially at
increased risk from asbestos exposure, regardless of whether or not
they are actually working with asbestos.
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\5\ GETF Report, pp. 12-13, 2003.
\6\ USGS (Virta), p. 28, 2003.
\7\ Lemen, 2003; Paustenbach et al., 2003.
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C. Asbestos Minerals
To understand the scientific literature, information about
asbestos, and the issues raised in the public comments, it is important
to understand the terminology used to describe minerals, asbestos, and
fibers. This section briefly reviews a number of key terms and concepts
associated with asbestos that we use in discussing this proposed rule.
1. Mineralogical Classification and Mineral Names
The terminology used to refer to how minerals form and how they are
named is complex. A mineral's physical properties, composition,
crystalline structure, and morphology determine its classification.
Asbestos minerals belong to either the serpentine (sheet silicate) or
the amphibole (double-chain silicate) family of minerals. Most of the
difficulties in classifying minerals as asbestos have involved the
amphiboles. The formation of a particular mineral (chemical
composition) or habit (morphology, crystalline structure) occurs
gradually and may be incomplete, producing intermediate minerals that
are difficult to classify. In the past, there have been several
different systems used to classify and name minerals that, in some
instances, led to inconsistent terminology and classification.
Currently, there is no single, universally accepted system for naming
minerals.
Asbestos is a commercial term used to describe certain naturally
occurring, hydrated silicate minerals. Several Federal agencies have
regulations that focus on these minerals. The properties of asbestos
that give it commercial value include low electrical and thermal
conductivity, chemical and crystalline stability and durability, high
tensile strength, flexibility, and friability. Much of the existing
health risk data for asbestos uses commercial mineral terminology.
Meeker et al. (2003) recognized the confusion associated with asbestos
nomenclature, stating--
Within much of the existing asbestos literature, mineral names
are not applied in a uniform manner and are not all consistent with
presently accepted mineralogical nomenclature and definitions.
a. Variations in Mineral Morphology.
There are many types of crystal habits, such as fibrous, acicular
(slender and needle-like), massive (irregular form), and columnar
(stout and column-like). The morphology of a mineral may not fit a
precise definition. For example, Meeker et al. (2003) state that the
Libby amphiboles contain ``a complete range of morphologies from
prismatic crystals to asbestiform fibers.'' Some minerals crystallize
in more than one habit. Some minerals, which can form in different
habits, have a different name for each habit; others do not.\8\ For
example, crocidolite is the name for the asbestiform habit and
riebeckite is the name for the same mineral in its nonasbestiform
habit. Tremolite and actinolite do not have different names
[[Page 43953]]
depending on habit; therefore, to distinguish between the different
habits, the descriptive term ``asbestiform'' or ``asbestos'' is added
to the mineral's name. If the identifying, descriptive term is not used
with the mineral name, misunderstandings or mistakes may occur.
---------------------------------------------------------------------------
\8\ Reger and Morgan, 1990; ATSDR, p. 138, 2001.
---------------------------------------------------------------------------
b. Variations in Mineral Composition.
Atoms similar in size and valence state can replace each other
within a mineral's crystal lattice, resulting in the formation of a
different mineral in the same mineral series. This process is gradual
and can occur to a different extent in the same mineral depending on
the geological conditions during its formation. For example, tremolite
contains magnesium, but no (or little) iron, and holds an end member
position in its mineral series. Iron atoms can replace the magnesium
atoms in tremolite and the resulting mineral may then be called
actinolite. The quantity of iron needed before the mineral is called
actinolite varies depending on the mineral classification scheme used.
Another example is winchite, which is an intermediate member of the
tremolite-glaucophane series, as well as an end member in its own
sodic-calcic series.\9\ Given the chemical similarity within the
series, winchite
[(NaCa)Mg4(Al,Fe3+)Si8O
22(OH)2] often has been reported as tremolite
[Ca2Mg5Si8O22(OH)2
].
---------------------------------------------------------------------------
\9\ Leake et al., p. 222, 1997.
---------------------------------------------------------------------------
A specific rock formation may contain a continuum of minerals from
one end member of a series to the other end member, creating a solid
solution of intermediate minerals. These intermediate minerals are
sometimes given names, while at other times they are not. Often, when
the exact chemical composition is not determined or determined to be a
number of different intermediate minerals, the mineral is named by one
or more of its end members, such as tremolite-actinolite or
cummingtonite-grunerite. The fibrous amphiboles in the Libby ore body,
for example, contain both end members and several intermediate
minerals. Meeker et al. (2003) state that--
The variability of compositions on the micrometer scale can
produce single fibrous particles that can have different amphibole
names at different points of the particle.
A mineral may also undergo transition to a different mineral
series. Kelse and Thompson (1989), Ross (1978), and USGS (Virta, 2002)
have commented on the chemical transition of anthophyllite to talc.
Stewart and Lee (1992) stated that fibrous talc might contain
intermediate particles not easily differentiated from asbestos. In the
context of systems for naming and classifying fibrous amphiboles,
Meeker et al. (2003) state that the regulatory literature often gives
nominal compositions for a mineral without specifying chemical
boundaries.
2. Differentiating Asbestiform and Nonasbestiform Habit
In the asbestiform habit, mineral crystals grow forming long,
thread-like fibers. When pressure is applied to an asbestos fiber, it
bends much like a wire, rather than breaks. Fibers can separate into
``fibrils'' of a smaller diameter (often less than 0.5 [mu]m). This
effect is referred to as ``polyfilamentous,'' and should be viewed as
one of the most important characteristics of asbestos. Appendix A of
the Environmental Protection Agency's (EPA's) Method for the
Determination of Asbestos in Bulk Building Materials \10\ defines
asbestiform as follows:
---------------------------------------------------------------------------
\10\ EPA, 1993.
* * * a mineral that is like asbestos, i.e., crystallized with
the habit [morphology] of asbestos. Some asbestiform minerals may
lack the properties which make asbestos commercially valuable, such
as long fiber length and high tensile strength. With the light
microscope, the asbestiform habit is generally recognized by the
following characteristics:
Mean aspect [length to width] ratios ranging from 20:1 to 100:1
or higher for fibers longer than 5 micrometers. Aspect ratios should
be determined for fibers, not bundles.
Very thin fibrils, usually less than 0.5 micrometers in width,
and two or more of the following:
--Parallel fibers occurring in bundles,
--Fiber bundles displaying splayed ends,
--Matted masses of individual fibers, and/or
--Fibers showing curvature.
In the nonasbestiform habit, mineral crystals do not grow in long
thin fibers. They grow in a more massive habit. For example, a long
thin crystal may not be polyfilamentous nor possess high tensile
strength and flexibility, but may break rather than bend. When pressure
is applied, the nonasbestiform crystals fracture easily into prismatic
particles, which are called cleavage fragments because they result from
the particle's breaking or cleavage, rather than the crystal's
formation or growth. Some particles are acicular (needle shaped), and
stair-step cleavage along the edges of some particles is common.
Cleavage fragments may be formed when nonfibrous amphibole minerals
are crushed, as may occur in mining and milling operations. Cleavage
fragments are not asbestiform and do not fall within our definition of
asbestos. For some minerals, distinguishing between asbestiform fibers
and cleavage fragments in certain size ranges is difficult or
impossible when only a small number of structures are available for
review, as opposed to a representative population. Meeker et al. (2003)
states that it is often difficult or impossible to determine
differences between acicular cleavage fragments and asbestiform mineral
fibers on an individual fiber basis. A determination as to whether a
mineral is asbestiform or not must be made, where possible, by applying
existing analytical methods. Although we have received comments
regarding the hazards associated with cleavage fragments, we do not
intend to modify our existing definition of asbestos with this
rulemaking.
III. History of Asbestos Regulation
When Federal agencies responsible for occupational safety and
health began to regulate occupational exposure to asbestos, studies had
already established that the inhalation of asbestos fibers was a major
cause of disability and death among exposed workers. The intent of
these first asbestos rules was to protect workers from developing
asbestosis.\11\
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\11\ GETF Report, p. 33, 2003.
---------------------------------------------------------------------------
A. MSHA's Asbestos Standards for Mining
1967-1969. In 1967, under the former Bureau of Mines, predecessor
to the Mining Enforcement and Safety Administration (MESA) and then
MSHA, the standard for asbestos exposure in mining was an 8-hour, time-
weighted average (TWA) PEL of 5 mppcf (million particles per cubic foot
of air). In 1969, the Bureau promulgated a 2 mppcf and 12 f/mL (fibers
per milliliter) standard.
1974-1976. In 1974, MESA promulgated a 5 f/mL standard for asbestos
exposure in metal and nonmetal mines (39 FR 24316). In 1976, MESA
promulgated a 2 f/cc standard (41 FR 10223) for asbestos exposure in
surface areas of coal mines. We retained these standards under the
authority of the Federal Mine Safety and Health Act of 1977.
1978. In November 1978, we promulgated a 2 f/mL standard for
asbestos exposure in metal and nonmetal mines (43 FR 54064). Since
then, we have made only nonsubstantive changes to our asbestos
standards, e.g., renumbering the section of the standard in 30 CFR.
MSHA's existing standards for asbestos at metal and nonmetal mines
at 30 CFR 56/57.5001 state,
[[Page 43954]]
(b) The 8-hour time-weighted average airborne concentration of
asbestos dust to which employees are exposed shall not exceed 2
fibers per milliliter greater than 5 microns in length, as
determined by the membrane filter method at 400-450 magnification (4
millimeter objective) phase contrast illumination. No employees
shall be exposed at any time to airborne concentrations of asbestos
fibers in excess of 10 fibers longer than 5 micrometers, per
milliliter of air, as determined by the membrane filter method over
a minimum sampling time of 15 minutes. ``Asbestos'' is a generic
term for a number of hydrated silicates that, when crushed or
processed, separate into flexible fibers made up of fibrils.
Although there are many asbestos minerals, the term ``asbestos'' as
used herein is limited to the following minerals: chrysotile,
Amosite, crocidolite, anthophylite asbestos, tremolite asbestos, and
actinolite asbestos.
The existing standard for asbestos at surface coal mines and
surface work areas of underground coal mines at 30 CFR 71.702 states,
(a) The 8-hour average airborne concentration of asbestos dust
to which miners are exposed shall not exceed two fibers per cubic
centimeter of air. Exposure to a concentration greater than two
fibers per cubic centimeter of air, but not to exceed 10 fibers per
cubic centimeter of air, may be permitted for a total of 1 hour each
8-hour day. As used in this subpart, the term asbestos means
chrysotile, amosite, crocidolite, anthophylite asbestos, tremolite
asbestos, and actinolite asbestos but does not include nonfibrous or
nonasbestiform minerals.
(b) The determination of fiber concentration shall be made by
counting all fibers longer than 5 micrometers in length and with a
length-to-width ratio of at least 3 to 1 in at least 20 randomly
selected fields using phase contrast microscopy at 400-450
magnification.
1989. In 1989, as part of our Air Quality rulemaking, we proposed
to lower the full-shift exposure limit for asbestos from 2 f/cc to 0.2
f/cc to address the excessive risk quantified in the Occupational
Safety and Health Administration's (OSHA's) 1986 asbestos rule (54 FR
35760). The Air Quality rulemaking, however, was withdrawn on September
26, 2002 (67 FR 60611). MSHA has not reinstated the Air Quality
rulemaking at this time.
B. OSHA's Asbestos Standards for General Industry and Construction
1971-1972. The initial promulgation of OSHA standards on May 29,
1971 (36 FR 10466) included a 12 f/cc PEL for asbestos. Then, on
December 7, 1971, in response to a petition by the Industrial Union
Department of the AFL-CIO, OSHA issued an emergency temporary standard
(ETS) on asbestos that established an 8-hour, TWA PEL of 5 f/cc and a
peak exposure level (ceiling limit) of 10 f/cc. In June 1972, OSHA
promulgated these limits in a final rule.
1975. In October 1975, OSHA proposed to revise its asbestos
standard by reducing the 8-hour, TWA PEL to 0.5 f/cc with a ceiling
limit of 5 f/cc for 15 minutes (40 FR 47652). OSHA stated that
sufficient medical and scientific evidence had accumulated to warrant
the designation of asbestos as a human carcinogen and that advances in
monitoring and protective technology made re-examination of the
standard appropriate. The final rule, however, reduced OSHA's 8-hour,
TWA asbestos PEL to 2 f/cc due to feasibility concerns. This limit
remained in effect until OSHA revised it in 1986.
1983-1986. On November 4, 1983, OSHA published another emergency
temporary standard (ETS) for asbestos (48 FR 51086), which would have
lowered the 8-hour, TWA PEL from 2 f/cc to 0.5 f/cc. The Asbestos
Information Association challenged the ETS in the U.S. Court of Appeals
for the 5th Circuit. On March 7, 1984, ruling on Asbestos Information
Association/North America v. OSHA (727 F.2d 415, 1984), the Court
invalidated the ETS. Subsequent to this decision, OSHA published a
proposed rule (49 FR 14116) that, together with the ETS, proposed two
alternatives for lowering the 8-hour, TWA PEL: 0.2 f/cc and 0.5 f/cc.
On June 17, 1986, OSHA issued comprehensive asbestos standards (51
FR 22612) governing occupational exposure to asbestos in general
industry workplaces (29 CFR 1910.1001), construction workplaces (29 CFR
1926.1101), and shipyards (29 CFR 1915.1001). The separate standards
shared the same asbestos PEL and most ancillary requirements. These
standards reduced OSHA's 8-hour, TWA PEL to 0.2 f/cc from the previous
2 f/cc limit. OSHA added specific provisions in the construction
standard to cover unique hazards relating to asbestos abatement and
demolition jobs.
Although tremolite, actinolite, and anthophyllite exist in
different forms, OSHA determined that all forms of these minerals would
continue to be regulated. Following promulgation of the rule, several
parties requested an administrative stay of the standard claiming that
OSHA improperly included nonasbestiform minerals. A temporary stay was
granted and OSHA initiated rulemaking to remove the nonasbestiform
types of these minerals from the scope of the asbestos standards.
1988. Several major participants in OSHA's rulemaking challenged
various provisions of the 1986 revised standards. In Building
Construction Trades Division (BCTD), AFL-CIO v. Brock (838 F.2d 1258,
1988), the U.S. Court of Appeals for the District of Columbia upheld
most of the challenged provisions, but remanded certain issues to OSHA
for reconsideration. In partial response, on September 14, 1988, OSHA
promulgated an excursion limit of 1 f/cc for asbestos as measured over
a 30-minute sampling period (53 FR 35610).
1992. OSHA's 1986 standards had applied to occupational exposure to
nonasbestiform actinolite, tremolite, and anthophylite. On June 8,
1992, OSHA deleted the nonasbestiform types of these minerals from the
scope of its asbestos standards. In evaluating the record, OSHA found
(57 FR 24310-24311) insufficient evidence that nonasbestiform
actinolite, tremolite, and anthophyllite present ``a risk similar in
kind and extent'' to their asbestiform counterparts. Additionally, the
evidence did not show that OSHA's removal of the nonasbestiform types
of these three minerals from its asbestos standard ``will pose a
significant risk to exposed employees.''
1994. On August 10, 1994, OSHA published a final rule (59 FR 40964)
that lowered its 8-hour, TWA PEL for asbestos to 0.1 f/cc and retained
the 1 f/cc excursion limit as measured over 30 minutes.
C. Other Federal Agencies Regulating Asbestos
Because the health hazards of exposure to asbestos are well
recognized, it is highly regulated. OSHA and MSHA have the primary
authority to regulate occupational exposures to asbestos. EPA regulates
asbestos exposure of state and local government workers in those states
that do not have an OSHA State Plan covering them. A number of other
Federal agencies, primarily EPA and the Consumer Product Safety
Commission (CPSC), regulate non-occupational asbestos exposures. For
example, CPSC regulates asbestos in consumer products, such as patching
compounds, under the Federal Hazardous Substances Act.
EPA regulates asbestos in air and materials. EPA's activities have
focused on environmental issues and the public health by reducing
emissions of hazardous gases and dusts from large industrial sources,
such as taconite ore processing,\12\ and the cleanup of contaminated
waste sites. EPA also regulates asbestos in schools. The mining and
processing of vermiculite in Libby, Montana, resulted in the spread
[[Page 43955]]
of asbestos to numerous homes, schools, and businesses throughout the
town. In November 1999, EPA responded to a request to study the
environmental contamination in the town of Libby and widespread
illnesses and death among its residents. In October 2002, EPA
designated the area as a Superfund site.
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\12\ EPA (68 FR 61868), 2003.
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D. Other Asbestos-Related Activities
There have been increasing numbers of studies on asbestos and its
hazards over the past 40 years. These efforts encompass government,
industry, and academia on a local, national, and international scale.
Government agencies and scientific groups in the United States, such as
the National Institute for Occupational Safety and Health (NIOSH), the
Agency for Toxic Substances and Disease Registry (ATSDR), the American
Conference of Governmental Industrial Hygienists (ACGIH), and the
National Toxicology Program (NTP), have addressed issues involving
carcinogens, such as asbestos. Organizations from other countries, such
as the United Kingdom (Health and Safety Executive) and Germany
(Deutche Forschungsgemeinschaft), also have addressed occupational
exposure to asbestos and other carcinogens. Similarly, the
International Agency for Research on Cancer (IARC) has published a
monograph on asbestos that summarizes evidence of its
carcinogenicity.\13\
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\13\ IARC, 1987.
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1. Interagency Asbestos Work Group (IAWG)
OSHA's and EPA's overlapping responsibilities and common interest
in addressing asbestos hazards led to the formation of the IAWG.
Participating Federal agencies include EPA, OSHA, CPSC, MSHA, NIOSH,
ATSDR, USGS, and the National Institute of Standards and Technology
(NIST). This work group of government agencies facilitates the sharing
of information and coordination of activities, including regulatory
activities, environmental assessment, technical assistance, consumer
protection, and developments in environmental analysis of contaminants.
The IAWG also seeks to harmonize the policies, procedures, and
enforcement activities of the participating agencies, thus minimizing
or eliminating potential conflicts for the regulated community. For
example, the IAWG is currently discussing the Federal definition of
asbestos.
2. National Institute for Occupational Safety and Health (NIOSH)
The Workers' Family Protection Act of 1992 (29 U.S.C. 671A)
directed NIOSH to study contamination of workers' homes by hazardous
substances, including asbestos, transported from the workplace. ATSDR,
EPA, OSHA, MSHA, the U.S. Department of Energy (DOE), and the Centers
for Disease Control and Prevention (CDC) assisted NIOSH in conducting
the study. For this proposed rule we focused on the asbestos-related
results of these studies.
NIOSH (1995) published its study results in a Report to Congress on
Workers' Home Contamination Study Conducted under the Workers' Family
Protection Act. This report summarizes incidents of home contamination,
including the health consequences, sources, and levels of
contamination. The study documents cases of asbestos reaching workers'
homes in 36 states in the United States and in 28 other countries.
These cases covered a wide variety of materials, industries, and
occupations. The means by which hazardous substances reached workers'
homes and families included taking the substance home on the worker's
body, clothing, tools, and equipment; cottage industries (i.e., work
performed on home property); and family visits to the workplace. In an
effort to reach employers and workers, NIOSH (1997) published its
recommendations in Protect Your Family: Reduce Contamination at Home.
This pamphlet summarizes the NIOSH study and provides recommendations
to prevent this contamination.
3. Agency for Toxic Substances and Disease Registry (ATSDR)
The Superfund Amendments and Reauthorization Act of 1986 (SARA)
directed ATSDR to prepare toxicological profiles for hazardous
substances most commonly found at specific waste sites. ATSDR and EPA
determined which hazardous substances pose the most significant
potential threat to human health and targeted them for study. Asbestos
is one of these targeted substances. ATSDR published one of the most
current toxicological profiles for asbestos in September 2001, which
was an update of an earlier asbestos profile.
In October 2002, ATSDR sponsored a meeting of expert panelists who
presented their evaluation of state-of-the-art research concerning the
relationship between fiber length and the toxicity of asbestos and
synthetic vitreous fibers. We have reviewed the evidence and arguments
presented in the updated asbestos toxicological profile and the meeting
proceedings and have discussed this information in this preamble, where
appropriate.
E. U.S. Department of Labor, Office of the Inspector General (OIG)
In November 1999, a Seattle newspaper published a series of
articles on the unusually high incidence of asbestos-related illnesses
and fatalities among individuals who had lived in Libby, Montana. There
was extensive national media attention surrounding the widespread
environmental contamination and asbestos-related deaths in Libby. Dust
and construction materials from the nearby vermiculite mine were the
alleged cause. This mine had produced about 90 percent of the world's
supply of vermiculite from 1924 until 1992.
Because MSHA had jurisdiction over the mine for two decades before
it closed, the OIG investigated MSHA's enforcement actions at the mine.
The OIG confirmed that the processing of vermiculite at the mine
exposed miners to asbestos. The miners then, inadvertently, had carried
the asbestos home on their clothes and in their personal vehicles.\14\
In doing this, the miners continued to expose themselves and family
members.
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\14\ Weis et al., 2001.
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1. OIG Report on MSHA's Handling of Inspections at the W.R. Grace &
Company Mine in Libby, Montana
The OIG published its findings and recommendations in a report
dated March 22, 2001. The OIG found that MSHA had appropriately
conducted regular inspections and personal exposure sampling at the
Libby mine and that there were no samples exceeding the 2.0 f/cc PEL
for the 10 years prior to the mine closing in 1992. The OIG concluded,
``We do not believe that more inspections or sampling would have
prevented the current situation in Libby.'' The OIG stated its belief
that there is a need for MSHA to lower its asbestos PEL.
In its report, the OIG supported the development and implementation
of control measures for asbestos and vermiculite mining and milling.
They also made recommendations for improving our effectiveness in
controlling this hazard. This proposed rule addresses our responses to
several of the OIG's recommendations.
2. MSHA's Libby, Montana Experience
W.R. Grace acquired the vermiculite mine in Libby, Montana, in
1963. At that time, the amphibole in the
[[Page 43956]]
vermiculite was called tremolite, soda tremolite, soda-rich tremolite,
or richterite, and researchers had already linked the mine dust to
respiratory disease.\15\ The suggested exposure limit for asbestos in
mining was much higher than current limits. The federal standard for
asbestos in mining dropped from 5 mppcf (about 30 f/mL) in 1967 to 2 f/
mL in 1978. When MESA (predecessor agency to MSHA) began inspecting the
operation, the exposure limit for asbestos was 5 f/mL.
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\15\ McDonald et al., 1986; Meeker et al., 2003; Peipins et al.,
2003.
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The mine operator, Federal mine inspectors, and representatives of
the U.S. Public Health Service [part of the Centers for Disease Control
and Prevention (CDC)] routinely sampled for asbestos at the Libby mine,
starting before the mine switched to wet processing in 1974, and
continued sampling periodically until the mine closed in 1992. MSHA
sampling at the Libby mine found no exposures exceeding the 5.0 f/cc
asbestos PEL from 1975 through 1978, and only a few over the 2.0 f/cc
asbestos PEL from 1979 through 1986. Almost all the samples would have
exceeded the 0.1 f/cc proposed limit. Miners' exposures continued to
decrease and more recent sampling since 1986 found few exposures
exceeding the OSHA PEL of 0.1 f/cc.
The results from our personal exposure sampling at the Libby mine
included many of the fibrous amphiboles present. In addition, the
results from TEM analysis of the air samples characterized the
mineralogy of the airborne fibers as tremolite and did not distinguish
between the species of amphiboles. Further characterization of the
amphibole minerals using Scanning Electron Microscopy/Energy Dispersive
X-ray Spectroscopy technology shows proportions of about 84 percent
winchite, 11 percent richterite, and 6 percent tremolite.\16\
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\16\ Meeker et al., 2003
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As early as 1980, MSHA had requested that NIOSH investigate health
problems at all vermiculite operations, including the mine and mill in
Libby, Montana. NIOSH published its study results in a series of three
papers (Amandus et al., Part I, 1987; Amandus and Wheeler, Part II,
1987; Amandus et al., Part III, 1987). The study of Amandus et al.
(Part I, 1987) along with that of McDonald et al. (1986) found that,
historically, the highest exposures to fibers at the Libby operation
had occurred in the mill and that exposures had decreased between the
1960's and 1970's. McDonald et al. (1986) reported--
In 1974, the old dry and wet mills were closed and the ore was
processed in a new mill built nearby which operated on an entirely
wet basis in which separation was made by vibrating screens,
Humphrey separators, and flotation.
McDonald et al. (1986) and Amandus and Wheeler (Part II, 1987) also
showed that, even at reduced exposure levels, there was still increased
risk of lung cancer among the Libby miners and millers.
3. MSHA's Efforts To Minimize Asbestos Take-Home Contamination
``Take-home'' contamination is contamination of workers' homes or
vehicles by hazardous substances transported from the workplace. As
discussed previously in this preamble, the widespread asbestos-related
disease among the residents of Libby, Montana, was attributed, in part,
to take-home contamination from the vermiculite mining and milling
operation in that town. The OIG report on MSHA's activities recommended
that we promulgate special safety standards similar to those in our
1989 proposed Air Quality rule (54 FR 35760) to address take-home
contamination.
In our 1989 Air Quality proposed rule, we had proposed that miners
wear protective clothing and other personal protective equipment before
entering areas containing asbestos. Our Air Quality proposed rule also
would have required miners to remove their protective clothing and
store them in adequate containers to be disposed of or decontaminated
by the mine operator. These proposed requirements were similar to those
in OSHA's asbestos standard and to NIOSH's recommendations.
In March 2000, shortly after the series of articles on asbestos-
related illnesses and deaths in Libby, Montana, we issued a Program
Information Bulletin (PIB No. P00-3) about asbestos. The PIB served to
remind the mining industry of the potential health hazards from
exposure to airborne asbestos fibers and to raise awareness about
potential asbestos exposure for miners, their families, and their
communities. At that time, we also issued a Health Hazard Information
Card (No. 21) about asbestos for distribution to miners to raise their
awareness about the health hazards related to asbestos exposure.
The PIB included information about asbestos, its carcinogenic and
other significant health effects, how miners could be exposed, where
asbestos occurs naturally on mining property, and what types of
commercial products may contain asbestos. It included recommendations
to help mine operators reduce miners' exposures, to prevent or minimize
take-home contamination, and for the selection and use of respiratory
protection. The PIB also urged mine operators to minimize exposures, to
improve controls, and to train miners, listing specific training topics
as essential for miners potentially exposed to asbestos.
During this same period, 2000 to 2003, we conducted an asbestos
awareness campaign and increased asbestos sampling. Section VII.D of
this preamble contains an additional discussion of measures to prevent
asbestos ``take-home'' contamination.
We have decided not to pursue a regulatory approach to minimizing
asbestos ``take-home'' contamination. Based on the existing levels of
asbestos exposures in the mining industry, comments on our 2002 ANPRM,
and testimony at the subsequent public meetings, we have determined
that a non-regulatory approach would be effective in minimizing
asbestos take-home contamination from mining operations.
4. Training Inspectors to Recognize and Sample for Asbestos
The OIG recommended that we increase MSHA inspectors' skills for
providing asbestos compliance assistance to mine operators. In
response, we developed a half-day multimedia training program that
includes the following:
A PowerPoint-based training presentation that examines
MSHA's procedures for air and bulk asbestos sampling.
An updated ``Chapter 8--Asbestos Fibers'' from the Metal
and Nonmetal Health Inspection and Procedures Handbook that serves as a
text for the training sessions.
A ``hands-on'' segment that allows the inspectors to
examine asbestos and asbestiform rock samples and the equipment used
for bulk sampling, and that provides the inspectors instruction and
practice in assembling and calibrating asbestos fiber air sampling
apparatus.
We gave this asbestos training to journeymen inspectors from March
2002 through April 2003, and added it to the training program for
entry-level inspectors.
IV. Health Effects of Asbestos Exposure
The health hazards from exposure to asbestos were discussed
extensively in the preamble to OSHA's 1983 final rule (51 FR 22615).
Subsequently, researchers have confirmed and
[[Page 43957]]
increased our knowledge of these hazards. Exposures in occupational and
environmental settings are generally due to inhalation, although some
asbestos may be absorbed through ingestion. While the part of the body
most likely affected (target organ) is the lung, adverse health effects
may extend to the linings of the chest, abdominal, and pelvic cavities,
and the gastrointestinal tract. The damage following chronic exposure
to asbestos is cumulative and irreversible. Workplace exposures to
asbestos may be chronic, continuing for many years. The symptoms of
asbestos-related adverse health effects may not become evident for 20
or more years after first exposure (latency period).
A. Summary of Asbestos Health Hazards
This section presents an overview of human health effects from
exposure to asbestos. We are proposing to use OSHA's 1986 risk
assessment to estimate the risk from asbestos exposures in mining.
OSHA's risk assessment has withstood legal scrutiny and the more recent
studies discussed later in this preamble support it. MSHA has placed
OSHA's risk assessment in the asbestos rulemaking record. It can also
be found at https://www.osha.gov.
Studies first identified health problems associated with
occupational exposure to asbestos in the early 20th century among
workers involved in the manufacturing or use of asbestos-containing
products.\17\ Early studies identified the inhalation of asbestos as
the cause of asbestosis, a slowly progressive disease that produces
lung scarring and loss of lung elasticity. Studies also found that
asbestos caused lung and several other types of cancer. For example,
mesotheliomas, rare cancers of the lining of the chest or abdominal
cavities, are almost exclusively attributable to asbestos exposure.
Once diagnosed, they are rapidly fatal. Asbestos-related diseases have
long latency periods, commonly not producing symptoms for 20 to 30
years following initial exposure.
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\17\ GETF Report, p. 38, 2003; OSHA (40 FR 47654), 1975.
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In the late 1960's, scientists correlated phase contrast microscopy
fiber counting methods with the earlier types of dust measurements.
This procedure provided a means to estimate earlier workers' asbestos
exposures and enabled researchers to develop a dose-response
relationship with the occurrence of disease. The British Occupational
Hygiene Society reported \18\ that a worker exposed to 100 fiber-years
per cubic centimeter (e.g., 50 years at 2 f/cc, 25 years at 4 f/cc, 10
years at 10 f/cc) would have a 1 percent risk of developing early signs
of asbestosis. The correlation of exposure levels with the disease
experience of populations of exposed workers provided a basis for
setting an occupational exposure limit for asbestos measured by the
concentration of the fibers in air.
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\18\ Lane et al., 1968; OSHA (40 FR 47654), 1975.
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As mentioned previously, the hazardous effects from exposure to
asbestos are now well known. For this reason, our discussion in this
section will focus on the results of the more recent studies and
literature reviews, those published since the publication of OSHA's
risk assessment, and those involving miners. One such review by
Tweedale (2002) stated,
Asbestos has become the leading cause of occupational related
cancer death, and the second most fatal manufactured carcinogen
(after tobacco). In the public's mind, asbestos has been a hazard
since the 1960s and 1970s. However, the knowledge that the material
was a mortal health hazard dates back at least a century, and its
carcinogenic properties have been appreciated for more than 50
years.
Greenberg (2003) also published a recent review of the biological
effects of asbestos and provided a historical perspective similar to
that of Tweedale.
The three most commonly described adverse health effects associated
with asbestos exposure are lung cancer, mesotheliomas, and pulmonary
fibrosis (i.e., asbestosis). OSHA, in its 1986 asbestos rule, reviewed
each of these diseases and provided details on the studies
demonstrating the relationship between asbestos exposure and the
clinical evidence of disease. In 2001, the ATSDR published an updated
Toxicological Profile for Asbestos that also included an extensive
discussion of these three diseases. A search of peer-reviewed
scientific literature using databases, such as Gateway, PubMed, and
ToxLine, accessed through the National Library of Medicine (NLM),
yielded nearly 900 new references on asbestos from January 2000 to
October 2003. Many of these recent articles \19\ continue to
demonstrate and support findings of asbestos-induced lung cancer,
mesotheliomas, and asbestosis, consistent with the conclusions of OSHA
and ATSDR. Thus, in the scientific community, there is compelling
evidence of the adverse health effects of asbestos exposure. This has
led some researchers and stakeholders to recommend a worldwide ban of
asbestos.\20\
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\19\ Baron, 2001; Bolton et al., 2002; Manning et al., 2002;
Nicholson, 2001; Osinubi et al., 2000; Roach et al., 2002.
\20\ Maltoni, 1999.
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B. Factors Affecting the Occurrence and Severity of Disease
The toxicity of asbestos, and the subsequent occurrence of disease,
is related to its concentration (C) in the mine air and to the duration
(T) of the miner's exposure. Other variables, such as the fiber's
characteristics or the effectiveness of the miner's lung clearance
mechanisms, also affect disease severity.
1. Concentration (C)
Currently, the concentration (C) of asbestos is expressed as the
number of fibers per cubic centimeter (f/cc). Some studies have also
reported asbestos concentrations in the number of fibers per milliliter
(f/mL), which is an equivalent concentration to f/cc. MSHA's existing
PELs for asbestos are expressed in f/mL for metal and nonmetal mines
and as f/cc for coal mines. To improve consistency and avoid confusion,
we express the concentration of airborne fibers as f/cc in this
proposed rule, for both coal and metal and nonmetal mines.
Older scientific literature (i.e., 1960's and 1970's) reported
exposure concentrations as million particles per cubic foot (mppcf) and
applied a conversion factor to convert mppcf to f/cc. OSHA (51 FR
22617) used a factor of 1.4 when performing these conversions. More
recently, Hodgson and Darnton (2000) recommended the use of a factor of
3. In our evaluation of the scientific literature, we did not
critically evaluate the impact of these and other conversion factors.
We note this difference here for completeness. Because we are relying
on OSHA's risk assessment, we are using OSHA's conversion factor
2. Time (T)
Epidemiological and toxicological studies generally report time (T)
in years (yr). The product of exposure concentration and exposure
duration (i.e., C x T) is referred to as ``fiber-years''.\21\ When
developing exposure-response relationships for asbestos-induced health
effects, researchers typically use ``fiber-years'' to indicate the
level of workplace exposure. Finkelstein \22\ noted, however, that this
product of exposure concentration times duration of exposure (C x T)
assumes an equal weighting of each variable (C, T).
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\21\ ATSDR, 2001; Fischer et al., 2002; Liddell, 2001; Pohlabeln
et al., 2002.
\22\ Finkelstein, 1995; ATSDR, p. 42, 2001.
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[[Page 43958]]
3. Fiber Characteristics
Baron (2001) reviewed techniques for the measurement of fibers and
stated, ``* * * fiber dose, fiber dimension, and fiber durability are
the three primary factors in determining fiber [asbestos] toxicity * *
*''. Manning et al. (2002) also noted the important roles of bio-
persistence (i.e., durability), physical properties, and chemical
properties in defining the ``toxicity, pathogenicity, and
carcinogenicity'' of asbestos. Roach et al. (2002) stated that--
Physical properties, such as length, diameter, length-to-width
(aspect ratio), and texture, and chemical properties are believed to
be determinants of fiber distribution [in the body] and disease
severity.
Many other investigators \23\ also have concluded that the
dimensions of asbestos fibers are biologically important.
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\23\ ATSDR, 2001; Osinubi et al., 2000; Peacock et al., 2000;
Langer et al., 1979.
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OSHA and MSHA currently specify that analysts count those fibers
that are over 5.0 micrometers ([mu]m) in length with a length to
diameter aspect ratio of at least 3:1. Several recent publications \24\
support this aspect ratio, although larger aspect ratios such as 5:1 or
20:1 have been proposed.\25\ There is some evidence that longer,
thinner asbestos fibers (e.g., greater than 20 [mu]m long and less than
1 [mu]m in diameter) are more potent carcinogens than shorter fibers.
Suzuki and Yuen (2002), however, concluded that ``Short, thin asbestos
fibers should be included in the list of fiber types contributing to
the induction of human malignant mesotheliomas * * * ''. More recently,
Dodson et al. (2003) concluded that all lengths of asbestos fibers
induce pathological responses and that researchers should exercise
caution when excluding a population of inhaled fibers based on their
length.
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\24\ ATSDR, 2001; Osinubi et al., 2000.
\25\ Wylie et al., 1985.
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We have determined that researchers have found neither a reliable
method for predicting the contribution of fiber length to the
development of disease, nor evidence establishing the exact
relationship between them. There is suggestive evidence that the
dimensions of asbestos fibers may vary with different diseases. A
continuum may exist in which shorter, wider fibers produce one disease,
such as asbestosis, and longer, thinner fibers produce another, such as
mesotheliomas.\26\ The scientific community continues to publish new
data that will enable regulatory agencies, such as MSHA, to better
understand the relationship between fiber dimensions, durability,
inhaled dose, and other important factors that determine the health
risks of exposure not only to asbestos, but also to other fibers.
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\26\ ATSDR, pp. 39-41, 2001; Mossman, pp. 47-50, 2003.
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4. Differences in Fiber Potency
The theory that the differences among fibers have an effect on
their ability to produce adverse effects on human hea