Coal Mine Dust Sampling Devices, 17512-17529 [2010-7308]
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Federal Register / Vol. 75, No. 65 / Tuesday, April 6, 2010 / Rules and Regulations
DEPARTMENT OF LABOR
Mine Safety and Health Adminisration
30 CFR Part 74
RIN 1219–AB61
Coal Mine Dust Sampling Devices
AGENCY: Mine Safety and Health
Administration, Labor.
ACTION: Final rule.
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SUMMARY: This final rule revises
requirements that the Mine Safety and
Health Administration (MSHA) and the
National Institute for Occupational
Safety and Health (NIOSH) use to
approve sampling devices that monitor
miner exposure to respirable coal mine
dust. The final rule updates approval
requirements for the existing ‘‘coal mine
dust personal sampler unit’’ to reflect
improvements in this sampler over the
past 15 years. The final rule also
establishes criteria for approval of a new
type of technology, the ‘‘continuous
personal dust monitor,’’ which is worn
by the miner and will report dust
exposure levels continuously during the
shift.
DATES: This final rule is effective June
7, 2010.
The incorporation by reference of
certain publications listed in the rule is
approved by the Director of the Federal
Register as of June 7, 2010.
FOR FURTHER INFORMATION CONTACT:
Patricia W. Silvey, Director, Office of
Standards, Regulations, and Variances,
MSHA, at silvey.patricia@dol.gov (Email), (202) 693–9440 (voice), or (202)
693–9441 (facsimile).
SUPPLEMENTARY INFORMATION: The
outline of the final rule is as follows:
I. Introduction
A. Background
B. Rulemaking History
II. Summary of Final Rule
Subpart A—Introduction
III. Section-By-Section Analysis
A. § 74.1 Purpose
B. § 74.2 Definitions
Subpart B—Requirements for Coal Mine
Dust Personal Sampler Unit
C. § 74.3 Sampler Unit
D. § 74.4 Specifications of Sampler Unit
E. § 74.5 Tests of Coal Mine Dust Personal
Sampler Units
F. § 74.6 Quality Control
Subpart C—Requirements for Continuous
Personal Dust Monitors (CPDMs)
G. § 74.7 Design and Construction
Requirements
H. § 74.8 Measurement, Accuracy, and
Reliability Requirements
I. § 74.9 Quality Assurance
J. § 74.10 Operating and Maintenance
Instructions
K. § 74.11 Tests of the Continuous
Personal Dust Monitor
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Subpart D—General Requirements for All
Devices
L. § 74.12 Conduct of Tests;
Demonstrations
M. § 74.13 Applications
N. § 74.14 Certificate of Approval
O. § 74.15 Approval Labels
P. § 74.16 Material Required for Record
Q. § 74.17 Changes After Certification
R. § 74.18 Withdrawal of Certification
IV. Regulatory Economic Analysis
A. Executive Order 12866
B. Benefits
C. Compliance Costs
D. Economic and Technological Feasibility
V. Regulatory Flexibility Act and Small
Business Regulatory Enforcement
Fairness Act
VI. Paperwork Reduction Act of 1995
VII. Other Regulatory Considerations
A. The Unfunded Mandates Reform Act of
1995
B. The Treasury and General Government
Appropriations Act of 1999: Assessment
of Federal Regulations and Policies on
Families
C. Executive Order 12630: Government
Actions and Interference With
Constitutionally Protected Property
Rights
D. Executive Order 12988: Civil Justice
Reform
E. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
F. Executive Order 13132: Federalism
G. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
I. Executive Order 13272: Proper
Consideration of Small Entities in
Agency Rulemaking
I. Introduction
A. Background
The Coal Mine Health and Safety Act
of 1969, the predecessor to the Federal
Mine Safety and Health Act of 1977,
required each operator of a coal mine to
take accurate samples of the amount of
respirable dust in the mine atmosphere
to which each miner in the active
workings of such mine is exposed.
Samples had to be taken by a device
approved by the Secretary and the
Secretary of Health, Education and
Welfare (Secretaries). MSHA’s existing
standards for joint approval of dust
sampling devices were issued in 1972.
They specified that MSHA’s role was to
determine whether the pump unit of a
sampling device was intrinsically safe,
and that the National Institute for
Occupational Safety and Health
(NIOSH) would determine whether the
sampling device met the requirements
of part 74.1
1 In 1978, responsibility for mine safety and
health was transferred from the Department of
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Since 1970, coal mine operators and
MSHA have used approved coal mine
dust personal sampler units (CMDPSUs)
to determine the concentration of
respirable dust in coal mine
atmospheres. These devices sample the
mine atmosphere by drawing mine air
through a filter cassette that collects
respirable coal mine dust. At the end of
a full shift or 8 hours, whichever time
is less, the cassette is sent to MSHA for
processing. Each cassette is weighed
under controlled conditions to
determine the average concentration of
respirable coal mine dust to which the
affected miners were exposed.
In the 1990s, NIOSH began research
and development to produce a
prototype technology for a new type of
personal dust monitor that could
provide readings of dust levels in the
mine immediately during the shift and
at the end of the shift. This would
eliminate the delay in obtaining an
offsite laboratory analysis which
requires days before the results are
made available to the mine operator and
MSHA. The promise of the new
technology, which is referred to
generically as a ‘‘continuous personal
dust monitor’’ (CPDM), was that it could
allow mine operators to promptly
identify and respond to dust exposures
exceeding the applicable MSHA
standards. With this new technology,
operators could evaluate causes of
overexposures, implement control
measures to reduce exposures, and
adjust such controls as necessary.
In 2003, Rupprecht and Patashnick
Co., Inc., now Thermo Fisher Scientific,
developed an initial prototype CPDM
under contract with NIOSH. The
prototype incorporated a unique
mechanical mass sensor system called
Tapered Element Oscillating
Microbalance (TEOM®). The TEOM
mass sensor is made up of a hollow
tapered tube, which is clamped at its
base and free to oscillate at its narrow
or free end on which the collection filter
is mounted. Electronics positioned
around the sensor cause the tube to
oscillate (or resonate) at its natural
frequency. When dust particles are
deposited on the collection filter, the
mass of the collection filter increases,
causing the natural oscillating frequency
of the tapered element to decrease.
Because of the direct relationship
between mass and frequency change,
the amount of respirable dust deposited
on the filter can be determined by
measuring the frequency change. The
Interior to the Department of Labor. In 1980 the
Department of Health Education and Welfare
became the Department of Health and Human
Services (HHS).
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Federal Register / Vol. 75, No. 65 / Tuesday, April 6, 2010 / Rules and Regulations
concentration of respirable dust in the
mine atmosphere is then determined by
a computer incorporated in the CPDM,
which divides the mass of dust
collected by the volume of mine air that
passed through the CPDM during the
sampled period. The result is reported
on the CPDM’s digital display. The
cumulative average dust concentration
is calculated and reported continuously
over the duration of the shift and at the
end of the shift. The data are also
retained for downloading onto any
personal computer with a Microsoft
Windows® operating system using
accompanying software. The prototype
also projected the end-of-shift average
dust concentration continuously during
the shift. This information can be used
to give early warnings of deteriorating
dust controls to mine operators,
allowing corrective action to be taken
before the dust control system fails
resulting in full-shift exposures
exceeding regulatory limits.2
In 2006, NIOSH, in collaboration with
MSHA, the mining industry, and labor,
completed extensive testing to evaluate
the accuracy of the pre-commercial
CPDM and its suitability for use in
underground coal mines in terms of
ergonomics and durability. The testing
verified that the device achieved with
95 percent confidence end-of-shift
measurements within ± 25 percent of
reference measurements 3 taken in a
variety of coal mines. In addition, the
testing demonstrated that the device
was acceptable to miners from an
ergonomics standpoint, and was
sufficiently durable to withstand the
conditions of transportation and use in
the mines.4
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B. Rulemaking History
Existing 30 CFR part 74, ‘‘Coal Mine
Dust Personal Sampler Units,’’ includes
procedures and requirements which
2 For a more complete description of the
technology, see: Volkwein, J.C., Vinson, R.P., S.J.
Page, L.J. McWilliams, G.J. Joy, S.E. Mischler, and
D.P. Tuchman. Laboratory and field performance of
a continuously measuring personal respirable dust
monitor. CDC RI 9669. September 2006. 47 pp. and
Volkwein, J.C., R.P. Vinson, L.J. McWilliams, D.P.
Tuchman, and S.E. Mischler, Performance of a New
Personal Respirable Dust Monitor for Mine Use.
CDC RI 9663. June 2004.
3 Reference measurements were established using
multiple gravimetric samplers in dust exposure
chambers for laboratory testing and using
CMDPSUs in a variety of coal mines for field
testing.
4 See: Volkwein, J.C., R.P. Vinson, S.J. Page, L.J.
McWilliams, G.J. Joy, S.E. Mischler, and D.P.
Tuchman. Laboratory and field performance of a
continuously measuring personal respirable dust
monitor. CDC RI 9669. September 2006. 47 pp. and
Volkwein, J.C., R.P. Vinson, L.J. McWilliams, D.P.
Tuchman, and S.E. Mischler. Performance of a New
Personal Respirable Dust Monitor for Mine Use.
CDC RI 9663. June 2004.
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MSHA and NIOSH use to jointly
approve the design, construction,
performance, and manufacturing quality
of the CMDPSU. Part 74 is designspecific and does not permit the
approval of coal mine dust sampling
devices of a different design than
currently approved. The CMDPSU is
currently the only sampling device
approved for use in coal mines to
monitor miners’ exposure to respirable
coal mine dust. The new CPDM
technology cannot be approved under
the existing regulation.
MSHA and NIOSH recognize that the
CPDM’s ability to measure in real time
the concentrations of respirable coal
mine dust to which a miner is exposed
could improve health protection of
miners because the CPDM allows mine
operators to take prompt action to
prevent dust overexposures.
Accordingly, the CPDM technology can
be a vital element in the strategy used
by mine operators and MSHA to more
effectively control miners’ exposure to
respirable coal mine dust.
To accommodate approval of the new
CPDM technology, MSHA and NIOSH
published a proposed rule to revise part
74 (on January 16, 2009 (74 FR 2915)).
The agency received comments on the
proposed rule and held one public
hearing on July 8, 2009, (74 FR 27265)
in Arlington, Virginia. The comment
period closed on August 14, 2009.
Although this final rule addresses
approval of the CPDM, existing
standards under 30 CFR parts 70, 71 and
90 will need to be revised before any
new dust exposure monitoring
technology can be used in coal mines
for compliance purposes. This final rule
does not address compliance-related
issues, such as how the CPDM will be
used, who would be required to wear
such a device and when.
The final rule also updates existing
design requirements for approving
CMDPSUs to reflect improvements
incorporated voluntarily by the
manufacturer since the mid 1990s in the
currently approved sampling device.
II. Summary of Final Rule
This final rule revises existing
requirements for the approval of
personal dust monitoring devices in 30
CFR part 74. It also establishes
performance-based and other
requirements for approval of the new
CPDM.
Part 74 is renumbered as follows:
Subpart A—General.
Subpart B—Approval Requirements for
Coal Mine Dust Personal Sampler Unit—
specifications for existing technology.
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Subpart C—Approval Requirements for
Continuous Personal Dust Monitors—
specifications for new technology.
Subpart D—General Requirements for All
Devices—administrative provisions
applicable to both the CMDPSU and CPDM.
III. Section-By-Section Analysis
Subpart A—General
A. § 74.1
Purpose
Final § 74.1, establishes requirements
for approval of coal mine dust sampling
devices designed to determine the
concentrations of respirable dust in coal
mine atmospheres; procedures for
applying for such approval; test
procedures; and labeling. Final 74.1 is
unchanged from the proposal and
addresses both CMDPSU and CPDM
technology. MSHA received no
comments on the proposal.
B. § 74.2
Definitions
Final § 74.2, like the proposal, is a
new section that defines key terms used
in the final rule.
Final paragraphs (a) and (b), like the
proposal, define the concepts of
‘‘accuracy’’ and ‘‘bias’’ as they apply to
CPDMs. They are key performance
parameters for testing and approving the
CPDM. MSHA received no comments on
the proposal.
Final paragraphs (c) and (d), like the
proposal, define the two types of coal
mine dust sampling devices covered by
this final rule, the ‘‘CMDPSU’’ and the
‘‘CPDM’’. The definitions are included to
distinguish between the two types of
dust monitoring technology. MSHA
received no comments on the proposal.
Final paragraph (e), like the proposal,
defines the ‘‘International Organization
for Standardization (ISO)’’ as a voluntary
consensus standards-setting
organization. An ISO standard is relied
on in this final rule (see § 74.9). MSHA
received no comments on the proposal.
Final paragraph (f), like the proposal,
defines the concept of ‘‘precision’’ as it
applies to the CPDM. Precision is the
third key performance parameter for the
testing and approval of CPDMs. MSHA
received no comments on the proposal.
Subpart B contains the approval
requirements that apply to the
CMDPSU.
C. § 74.3
Sampler Unit
Final § 74.3, like the proposal,
renumbers existing § 74.2, and specifies
the major components of a CMDPSU
and remains unchanged from the
proposal. MSHA received no comments
on the proposal.
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D. § 74.4
Unit
Federal Register / Vol. 75, No. 65 / Tuesday, April 6, 2010 / Rules and Regulations
Specifications of Sampler
Final § 74.4, like the proposal,
renumbers existing § 74.3 and updates
the requirements of the existing
provision to reflect currently approved
sampling technology.
Final paragraph (a)(1) updates
existing pump dimensions to reflect the
smaller and more compact size of
currently approved sampling device: 4
inches (10 centimeters) in height; 4
inches (10 centimeters) in width; and 2
inches (5 centimeters) in thickness.
A commenter suggested that volume
instead of size would be a preferable
design parameter as it would not restrict
future pump innovation and
improvement and recommended a
nominal value of 500–525cm3. MSHA
believes that this suggestion is
inconsistent with the design-specific
regulatory requirements applicable to
the CMDPSU. MSHA experience
indicates that specifying size as a design
parameter has not restricted pump
innovation and improvement as
evidenced by the reduced size of the
currently-approved pump unit, resulting
from product improvements undertaken
voluntarily by the manufacturer. The
final rule remains unchanged from the
proposal.
Final paragraph (a)(2), like the
proposal, updates the existing
maximum pump weight to 20 ounces
(567 grams) to reflect the reduction in
the weight of the currently approved
pump unit. MSHA received no
comment on the proposal.
Final paragraph (a)(3), like the
proposal, updates existing requirements
for the construction of the pump case
and pump components by requiring
protection against radio frequency and
electromagnetic interference. This
improvement will prevent potential
instrument error or malfunction due to
exposure to electromagnetic fields and
various radio frequency ranges and
signal strengths encountered in coal
mines from power stations, electric
motors and remote control transmitters.
The final rule includes the proposed
requirement that the case and
components of the pump unit must be
of durable construction and tight-fitting.
MSHA received no comments on the
proposal.
Final paragraphs (a)(4) and (a)(5), are
the same as the proposal. These
provisions require that: (1) The pump
exhaust into the pump case to maintain
a slight positive pressure; and (2) the
pump unit be equipped with an ON/
OFF switch that is protected against
accidental operation during use and
protected to keep dust from entering the
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mechanisms. MSHA received no
comments on the proposal.
Final paragraph (a)(6), like the
proposal, requires the pump unit to be
equipped with a means to make flow
rate adjustments accessible from outside
the case. The flow rate adjuster must be
recessed in the pump case and protected
against accidental adjustment. If the
pump is capable of maintaining flow
rate consistency without adjustment, an
external flow rate adjuster is not
required. MSHA received no comments
on the proposal.
Final paragraph (a)(7), like the
proposal, requires that the power supply
for the pump be a suitable battery
located in the pump case or in a
separate case which attaches to the
pump by a permissible electrical
connection. MSHA received no
comments on the proposal.
Final paragraph (a)(8), like the
proposal, requires that the irregularity
in flow rate due to pulsation have a
fundamental frequency of not less than
20 Hz. It also requires that the quantity
of respirable dust collected with a
sampling device be within ± 5 percent of
that collected with a sampling head
assembly operated with nonpulsating
flow. MSHA received no comments on
the proposal.
Final paragraphs (a)(9) and (a)(10),
like the proposal, retains the existing
provisions requiring the pump unit to
be equipped with a belt clip and a
suitable connection to allow the battery
to be recharged without removing it
from the pump case or battery case.
MSHA received no comments on the
proposal.
Final paragraphs (a)(11), like the
proposal, requires a visual indication of
the flow rate and specifies the
calibration of the flow rate indicator. It
updates existing calibration
requirements to be within ±5 percent at
2.2, 2.0, and 1.7 liters per minute. The
higher flow rates for calibration
purposes better reflect the operating
flow rate range specified in final
paragraph (a)(12). MSHA received no
comments on the proposal.
Final paragraph (a)(12), like the
proposal, retains the existing
requirement that the pump operate
within a range from 1.5 to 2.5 liters per
minute and be adjustable over this
range. MSHA received no comments on
the proposal.
Final paragraph (a)(13), like the
proposal, requires the flow rate to
remain consistent or stable over at least
a 10-hour period, when the pump is
operated at 2 liters per minute. This
flow-rate consistency reflects the
operating range of the currently
approved sampling device and the
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prevalence of work shifts exceeding 8
hours in duration. The final rule, like
the proposal, does not include the
existing requirement to readjust the flow
rate during the shift since the currently
approved sampling device is designed
to maintain a constant flow rate without
requiring any readjustments during
sampling. MSHA received no comments
on the proposal.
Final paragraph (a)(14), like the
proposal, is a new provision that
requires the pump unit to be equipped
with a flow restriction indicator. This
new requirement reflects technology
incorporated in the currently approved
sampling device to prevent the
shutdown of the pump during sampling
and subsequent loss of the sample if the
flow restriction is not corrected. The
flow restriction indicator enables more
accurate sampling of the mine
atmosphere in the active workings.
MSHA received no comments on the
proposal.
Final paragraph (a)(15), like the
proposal, specifies the required
maximum expected operating time that
the pump with a fully charged battery
pack must be capable of operating at
specific flow rates and sampling device
loading. This paragraph reflects the
higher level of operating performance
inherent in the currently approved
sampling device to permit sampling of
shifts longer than 8 hours commonly
worked today. Under the final rule, the
existing resistance requirement for 8
hours of operation at a flow rate of 2
liters per minute is increased from 4
inches (10 centimeters) to 25 inches (64
centimeters) of water, as measured at
the inlet of the pump. The final rule,
like the proposal, adds a new provision
that reflects technology incorporated in
the currently approved sampling device.
It requires the pump unit to operate not
less than 10 hours at a flow rate of 2.5
liters per minute against a resistance of
15 inches (38 centimeters) of water.
MSHA received no comments on the
proposal.
Final paragraph (a)(16), like the
proposal, is a new provision that
requires the pump unit to be equipped
with a low battery indicator. This
provision reflects technology
incorporated in the currently approved
sampling device and is considered an
important design feature. Failure of the
battery during sampling results in loss
of the sample and the inability to
determine the concentrations of
respirable coal mine dust in the work
environment being monitored. MSHA
received no comments on the proposal.
Final paragraph (a)(17), like the
proposal, is a new provision and
requires the pump unit to be equipped
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with an elapsed time indicator
displaying the actual pump run time
after the pump is shut down due to a
flow restriction or low battery power, or
at the end of the sampling shift. This
provision reflects technology
incorporated in the currently approved
sampling device and is necessary to
determine if sampling was conducted
for the required duration. Knowing the
actual sampling time is essential for
determining the concentration of
respirable coal mine dust in the work
environment being monitored. MSHA
did not receive any comments on the
proposal.
Final paragraph (b), like the proposal,
addresses requirements for the sampling
head assembly of the CMDPSU, which
consist of a cyclone and a filter
assembly.
Final paragraphs (b)(1) and (b)(2)(i),
like the proposal, specify the
components and construction of the
cyclone, including dimensions of the
components, and the characteristics of
the collection filter. MSHA did not
receive any comments on the proposal.
Final paragraph (b)(2)(ii), like the
proposal, specifies characteristics and
construction of the capsule enclosing
the filter, and requires that the capsule
prevent visual inspection of the filter
surface or filter loading. It reflects the
design and construction of the currently
approved filter assembly, called the dust
cassette, to safeguard the accuracy,
integrity, and validity of the collected
sample. MSHA did not receive any
comments on the proposal.
Final paragraph (b)(2)(iii), like the
proposal, specifies requirements for the
cassette enclosing the capsule. It
requires the cassette to completely
enclose the filter capsule so as to
prevent contamination and intentional
or inadvertent alteration of dust
deposited on the filter. The final rule
also requires the cassette be designed to
prevent reversal of the air flow through
the capsule or other means of removing
dust collected on the filter. These
requirements reflect design of the
currently approved filter assembly or
dust cassette technology and are
intended to safeguard the accuracy,
integrity, and validity of the sample.
MSHA did not receive any comments on
the proposal.
Final paragraphs (b)(3) and (b)(4) are
the same as the proposal. Final
paragraph (b)(3) addresses the
connections between the cyclone vortex
finder and the filter capsule and
connections between the filter capsule
and hose. Final paragraph (b)(4), like the
proposal, addresses clamping and
positioning requirements of
components. It requires that the
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cyclone-cassette assembly be firmly in
contact, airtight and be attached firmly
to a backing plate or other means of
holding the sampling head in position.
MSHA did not receive any comments on
the proposal.
Final paragraph (b)(5), like the
proposal, includes requirements for the
hose connecting the sampler pump and
the filter assembly. It requires that the
hose be clear plastic. This provision
reflects currently-approved technology
and allows for examination of the
external tubing to assure that it is clean
and free of leaks, as accumulations or
leaks could affect the accuracy of
sampling results. MSHA did not receive
any comments on the proposal.
Final paragraph (c) addresses
requirements for the battery charger of
the CMDPSU.
Final paragraph (c)(1), like the
proposal, specifies the voltage and
frequency requirements for the battery
charger. It reflects currently used power
supply voltage of 110 (VAC)(nominal).
MSHA did not receive any comments on
the proposal.
Final paragraphs (c)(2) and (c)(3), like
the proposal, require that the battery
charger be provided with a cord and
polarized connector and that it be fused
and have a grounded power plug.
MSHA did not receive any comments on
the proposal.
Final paragraph (c)(4), like the
proposal, reflects currently approved
technology and requires that the battery
charger be capable of fully recharging
the battery in the pump unit within 16
hours. MSHA did not receive any
comments on the proposal.
E. § 74.5 Tests of Coal Mine Dust
Personal Sampler Units
Final § 74.5, like the proposal,
renumbers existing § 74.4 and provides
authority for NIOSH and MSHA testing
to evaluate whether the CMDPSU meets
the requirements of the final rule.
MSHA did not receive any comments on
the proposal.
F. § 74.6
Quality Control
Final § 74.6, like the proposal,
includes a clarifying reference to final
§ 74.13 (filing applications). MSHA did
not receive any comments on the
proposal.
Subpart C—Requirements for
Continuous Personal Dust Monitors
(CPDMs)
G. § 74.7 Design and Construction
Requirements
Final § 74.7 provides design and
construction requirements for the
CPDM. The requirements are
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performance-oriented to allow
manufacturers flexibility for continued
innovation in this new technology.
Where necessary and appropriate, the
final rule includes design requirements
to assure miner safety or accommodate
specific mining conditions.
Final paragraph (a), like the proposal,
requires that the CPDM be designed and
constructed to allow miners to work
safely. It also requires that the device be
suitable to work requirements and
working conditions of coal mining.
MSHA did not receive any comments on
the proposal.
Final paragraph (b), like the proposal,
addresses ergonomic design
requirements. It requires that, prior to
filing an application under final § 74.13,
the applicant must develop a testing
protocol to determine if coal miners can
wear the CPDM safely and without
discomfort or impairment in the
performance of their work duties
throughout a full work shift. The
protocol includes provisions for testing
in one or more active mines under
routine operating conditions. The
testing protocol must be submitted to
NIOSH prior to testing. In addition, the
testing protocol and testing results must
be submitted to NIOSH as part of the
application for approval. NIOSH will
advise and assist the applicant in
developing an adequate testing protocol
and arranging for adequate and
competent testing resources, including,
but not limited to, identifying testing
experts and facilitating the cooperation
of coal operators and miners. NIOSH
reserves the authority to waive the
requirement for the applicant to conduct
such testing when it is apparent ‘‘that
the device can be worn safely, without
discomfort, and without impairing a
coal miner in the performance of duties
throughout a full work shift.’’ MSHA did
not receive any comments on the
proposal.
Final paragraph (c), like the proposal,
requires that the weight of a CPDM add
no more than 2 kg to the total weight
carried by the miner. However, a CPDM
combined with other functions, such as
communications or illumination, could
weigh more than 2 kg if offset by the
weight of a device the miner would no
longer have to carry. In this case, the
total added weight must not exceed the
weight normally carried by miners
without CPDMs by more than 2 kg. The
2-kg limit is based on the professional
judgment of MSHA and NIOSH staff
that the added load to miners needs to
be minimized, considering that the
safety gear and equipment currently
worn and carried by underground coal
miners can weigh up to approximately
16 kg. The limit in the final rule reflects
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the weight of the prototype CPDM,
which in NIOSH testing was worn and
used by miners for full shifts and
proved to be tolerable. The prototype
device weighed approximately 3 kg, but
served to power the cap lamp as well,
so that a separate battery was not
needed for the miner’s cap lamp. In
combination, the prototype with its
dual-use battery increased the personal
equipment load of the miners by less
than 2 kg. MSHA did not receive any
specific comments on this provision.
Final paragraph (d) requires that the
CPDM provide accurate end-of-shift
measurements of average respirable coal
mine dust concentrations within the
range of 0.2 to 4.0 mg/m3. For end-ofshift average concentrations exceeding
4.0 mg/m3, the CPDM must provide a
reliable indication that the
concentration exceeded 4.0 mg/m3. This
represents a change from the proposal in
response to comments, which indicated
some confusion and misinterpretation of
the proposal. The proposal would have
required that the CPDM provide
accurate end-of-shift measurements of
average respirable dust concentrations
within the range of 10% to 2 times the
permissible exposure limit (PEL) for
respirable coal mine dust (currently 2.0
mg/m3 when quartz content does not
exceed 5%), and provide a reliable
indication when the concentration
exceeds 2 times the PEL. A commenter
asked if the proposed requirement
would remain the same if a dust sample
contains more than 5% quartz causing
the PEL to be subsequently reduced.
This commenter also asked if the
proposed requirement would remain the
same if MSHA ever reduces the PEL for
respirable dust or for quartz dust
through future rulemaking. MSHA
believes that the proposal could have
been more clearly stated.
To provide better clarity regarding the
actual range of average respirable coal
mine dust concentrations over which
the CPDM must provide accurate endof-shift measurements, the final rule
establishes the measurement range by
defining a lower and upper range of
average dust concentrations over which
the CPDM must perform accurately. The
final rule does not change the original
intent of the proposal, which was to
establish performance criteria for
approving CPDM devices that accurately
measure end-of-shift average dust
concentrations based on current directreading monitoring technology.
The measurement range in the final
rule reflects the actual range of average
dust concentrations over which current
CPDM technology performed accurately.
The final requirement assures that the
CPDM will provide accurate
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measurements of actual dust
concentrations as low as 0.2 mg/m3
(10% of the existing PEL) to permit
monitoring of dust concentrations in
active workings of coal mines under
existing reduced standards due to quartz
with no further accuracy testing. MSHA
did not intend to address any issues
related to a lower PEL for respirable coal
mine dust or quartz in this rulemaking.
In the event the PEL is reduced through
rulemaking in the future resulting in
reduced dust standards below 0.2 mg/
m3, the accuracy of the CPDM in
monitoring the lower concentration
limits would need to be verified with
additional testing.
Final paragraph (e), like the proposal,
requires that the CPDM operate reliably
and accurately within the full range of
environmental conditions encountered
in coal mines. It requires that the CPDM
operate reliably and accurately at any
ambient temperature and varying
temperatures ranging from minus 30 to
plus 40 degrees Centigrade; at any
atmospheric pressure from 700 to 1000
millibars; at any ambient humidity from
10 to 100 percent relative humidity; and
while exposed to water mists generated
for dust suppression and while
monitoring atmospheres including such
water mists. These parameters, in
addition to those in paragraphs (f) and
(g) of this section, address the full range
of environmental conditions found in
coal mines. MSHA and NIOSH
specifically solicited comments on these
parameters, as well as any others that
might be appropriate. MSHA did not
receive any comments on the proposal.
Final paragraph (f), like the proposal,
requires that the CPDM meet standards
established by the American National
Standards Institute (ANSI), the Federal
Communications Commission (FCC),
and the International Electrotechnical
Commission (IEC) for control of and
protection from electromagnetic
interference. The FCC is an independent
Federal agency that regulates
radiofrequency emitting devices. ANSI
and IEC are voluntary standards-setting
organizations, the former covering a
variety of technical and management
areas and the latter specializing in
electrotechnology. The use of these
standards would address the potential
for interference associated with the
increasing use of radiofrequency
controls for mining machinery and mine
communication systems.
Final paragraph (f)(1) requires the
CPDM to meet emissions requirements
of IEEE Std. C95.1–2005, IEEE Standard
for Safety Levels with Respect to Human
Exposure to Radio Frequency
Electromagnetic Fields, 3 kHz to 300
GHz. The proposal would have required
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that the operator meet the requirements
of ANSI C95.1–1982 (Standard for
Safety Levels with Respect to Human
Exposure to Radio Frequency
Electromagnetic Fields). The ANSI
C95.1–1982 reference in the proposal
has been updated and the final rule is
changed to include the latest reference.
MSHA did not receive any comments on
the proposal.
Final paragraph (f)(2), like the
proposal, requires that the CPDM meet
the immunity and susceptibility
requirements of the International
Electrotechnical Commission (IEC)
61000–4–6.
A commenter stated that the proposal
was confusing as to the depth of testing
required. This commenter asked if the
intent of the proposal was to test against
the entire section of 610000–4 through
61000–6, or only sections 61000–4 and
61000–6, or the specific test defined in
61000–4–6.
MSHA inadvertently cited the IEC
reference in the proposal as IEC 61000–
4 and 61000–6. The proposal should
have been phrased as follows: ‘‘persons
must proceed in accordance with IEC
61000–4–6 (Electromagnetic
compatibility—Part 4–6: Testing and
measurement techniques—Immunity to
conducted disturbances, induced by
radio-frequency fields).’’ In response to
the commenter’s question, the Agency
clarified in the hearing notice (74 FR
27263) its intent that the proposed test
be in accordance with the specific test
defined in IEC 61000–4–6. The final
rule includes this nonsubstantive
correction.
Final paragraph (g), like the proposal,
requires that the CPDM be designed and
constructed to remain safe and accurate
after undergoing durability evaluation
involving vibration and drop tests
representative of conditions of use in
the mine. In testing for vibration,
NIOSH will use Military Standard 810F,
514.5. This test measures the degree of
vibration expected while the device is
worn by miners on and operating
mining equipment and during transport
in and out of the mine. The drop test
that NIOSH applies will involve three 3foot drops onto a bare concrete surface
(one drop testing each axis of the
device). This test represents the
occasional drops and knocking of the
device expected during use of the
device by miners. NIOSH will conduct
the testing regime on test devices prior
to further testing by the applicant under
§ 74.8 and intrinsic safety testing by
MSHA under § 74.11(d). MSHA did not
receive any comments on this proposal.
Final paragraphs (h)(1) and (2) require
adequate legibility or audibility of
monitoring results, computer (i.e.,
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digital) recording of results in a form
compatible with widely available
computer technology, and reporting of
results as cumulative mass
concentration in units of mass per
volume of air (mg/m3). The visibility
requirement for a minimum digital
character height of 6 millimeters is
based on testing during CPDM prototype
development. All other requirements in
this provision allow flexibility for new
innovative designs that would provide
timely, reliable, and appropriately
quantified information.
A commenter stated that, except for
provisions for the size of characters and
end of shift results, there is nothing in
the rule that provides for results for
shorter time periods (from minutes to
hours). This commenter stated that an
instrument that provides only the end of
shift results would not be acceptable.
Additionally, whatever number the
instrument displays should not be
truncated and, instead, should be
rounded as is the customary practice in
most other applications. This
commenter suggested that the
information displayed on the CPDM be
the same as described in NIOSH
Publication RI 9669, ‘‘Laboratory and
Field Performance of a Continuously
Measuring Personal Respirable Dust
Monitor.’’
Since monitoring of compliance with
the applicable dust standard will
continue to be based on the average dust
concentration measured over a full shift,
it is vital that the CPDM provide
accurate full-shift (or end-of-shift)
measurements. It should be noted that
shorter time period data may also be
available. However, MSHA believes that
to prescribe the time period for intrashift measurements of less than 8 hours
may limit future CPDM development.
The final rule does not include the
commenter’s suggestion.
In response to the commenter’s
suggestion that the concentration values
displayed by the instrument should be
rounded instead of truncated, paragraph
(h)(2) in the final rule has been modified
to require the CPDM to report
cumulative mass concentrations with
two significant figures of accuracy
rounded as the customary practice. The
commenter’s suggestion that the
information displayed on the CPDM be
the same as described in NIOSH
Publication RI 9669, ‘‘Laboratory and
Field Performance of a Continuously
Measuring Personal Respirable Dust
Monitor’’ was not adopted to permit
continued innovation in how dust
concentration measurements are
displayed by CPDMs.
Final paragraph (i), like the proposal,
requires that the power source for the
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CPDM have sufficient capacity to enable
continuous sampling for 12 hours in a
coal mine dust atmosphere up to 4.0
mg/m3. This requirement provides
reasonable assurance that the power
supply is sufficient to enable accurate
measurement of respirable dust
concentrations for 12-hour work shifts,
which according to MSHA data, would
accommodate some of the longer
recorded shifts currently being worked
in underground coal mines. MSHA’s
data indicate that 98 percent of work
shifts in active underground mines are
10 hours or less and over 99 percent of
work shifts are 12 hours or less.
It should be recognized that if dust
concentrations in the active workings
being monitored exceed 4.0 mg/m3
continuously over a 12-hour period, a
power supply meeting this requirement
might not be sufficient to sustain
monitoring for the complete shift. This
is because sampling environments
containing higher dust concentrations
will result in increased particulate
loading on the sample collection media
which places greater power demands on
the CPDM to increase pump speed and
maintain the required sample flow rate
without requiring any mid-course
adjustments. However, since over 99
percent of the underground coal mines
work shifts that are 12 hours or less, the
final rule provides sufficient assurance
that the CPDM will have the power
capacity to monitor high dust
concentrations during the entire work
shift, and to cumulatively document
that miner’s exposure exceeded the PEL
for the full shift. Final paragraph (i), like
the proposal, also requires that a CPDM
that uses a rechargeable battery be
recharged using the standard power
supplies in mines (110 VAC).
Several commenters supported the
proposed requirement that the CPDM be
powered continuously for 12 hours
since miners work shifts longer than 8
hours. However, they also suggested
that CPDMs be capable of operating for
a minimum of 16 hours to accommodate
full work shifts, up to 16 hours. One of
the commenters further suggested that,
if this is not feasible, it should be
required in two years. While MSHA
recognizes that some miners may work
longer than 12 hours, those situations
are neither typical nor wide spread.
Since the performance requirements in
the final rule are intended to address
typical mining operating conditions,
they do not include the commenters’
suggestion that the CPDM be capable of
operating up to 16 hours. Further, given
the current state of battery technology,
a 16-hour battery would significantly
increase the size and weight of the
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CPDM beyond the limits specified in
this final rule.
Final paragraph (j), like the proposal,
requires that if a CPDM uses a pump to
sample the atmosphere, it must perform
with a flow stability within ± five
percent of the calibrated flow for 95%
of samples for a continuous duration of
12 hours.5 This requirement is integral
to achieving representative, accurate
measurements of respirable coal mine
dust concentrations. The paragraph also
requires that the applicant specify the
flow calibration maintenance interval
necessary to achieve the required level
of flow stability in the calibration
instructions for the device. MSHA did
not receive any comments on the
proposal.
Final paragraph (k), like the proposal,
requires that a CPDM using a
rechargeable battery have a battery
check feature to indicate to the user that
the device is adequately recharged to
operate as intended for an entire work
shift of up to 12 hours under normal
conditions of use. This important
feature will minimize using CPDMs
whose battery was not fully charged to
permit full-shift monitoring without
experiencing a monitoring failure
during the shift due to low battery
power. MSHA did not receive any
comments on the proposal.
Final paragraph (l), like the proposal,
sets forth requirements for CPDMs that
share components with other personal
equipment carried by an underground
miner, such as cap lamps.
Final paragraph (l)(1), like the
proposal, requires the applicant to
obtain necessary approvals required for
other devices if the CPDM is integrated
or shares functions with such devices
used in mines, such as cap lights or
power sources, prior to receiving final
approval of the CPDM from NIOSH.
This provision enables NIOSH to assure
all requirements, as appropriate, are met
for other devices integrated with or
sharing functions with the CPDM that
are not approved by NIOSH.
Final paragraph (l)(2), like the
proposal, requires that the CPDM
operate effectively with the integrated
functions. This provision assures that
the CPDM is not compromised by
integration of functions and provides
reasonable assurance that the device
functions as intended. MSHA did not
receive any comments on the proposal.
Final paragraph (m), like the proposal,
specifies performance requirements that
help assure that CPDMs are designed to
prevent intentional tampering or
inadvertent altering of monitoring
5 NIOSH Manual of Analytic Methods, Method
0600, Issue 3, Fourth Edition, January 15, 1998.
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results. It requires that the CPDM have
a safeguard or indicator which either
prevents altering the measuring or
reporting functions of the device or
indicates if these functions have been
altered.
This requirement will assure that
manufacturers design and incorporate
tampering safeguards and indicators in
the CPDM that address foreseeable
actions by users. It also allows NIOSH
to require, to the extent feasible,
changes in the design of an already
approved device, following discovery of
tampering methods or inadvertent
actions that can alter monitoring results.
A commenter supported the proposed
requirement; however, the commenter
doubted that safeguards could prevent
tampering altogether. This commenter
suggested that MSHA have other
methods to prevent and detect
tampering and to prosecute those who
perpetuate this action. MSHA
recognizes the importance of having a
credible monitoring program that
provides meaningful health surveillance
and confidence in the program. MSHA’s
actions to improve sampling technology,
to investigate questionable sampling
practices, and take appropriate legal
action demonstrate the Agency’s
commitment to maintain a credible and
reliable dust monitoring program. While
it may be difficult to prevent tampering
all together, MSHA has not ignored this
important issue and believes that the
CPDM technology should limit the
ability to alter monitoring results.
MSHA believes that the final rule
addresses commenters’ concerns with
respect to tampering or altering CPDM
results. MSHA will continue to evaluate
operator results, conduct its own
sampling, follow-up on reports of
inappropriate sampling practices,
conduct investigations as it has in the
past, and take appropriate enforcement
action.
Final paragraph (n), like the proposal,
requires that the CPDM be designed to
assure that it can be properly cleaned
and maintained to perform accurately
and reliably for the duration of its
service life. The infiltration and
accumulation of dust and moisture in
components can adversely affect the
operability and monitoring accuracy of
a CPDM. MSHA did not receive any
comments on the proposal.
H. § 74.8 Measurement, Accuracy, and
Reliability Requirements
Final § 74.8, like the proposal,
establishes new performance
requirements for CPDMs. These
requirements reflect current evaluation
methods for assessment of directreading monitors. These methods have
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been summarized and issued as general
guidelines by NIOSH in ‘‘Components
for the Evaluation of Direct-Reading
Monitors for Gases and Vapors’’.6 The
requirements also reflect the state-ofthe-art technology of the CPDM
prototype. Accordingly, this final rule
establishes a science-based, feasible
baseline for the performance of the new
CPDM technology. Upon request,
NIOSH will provide a report on the
performance of the prototype CPDMs.
The results are partially summarized in
several peer-reviewed journal articles.7
Final paragraph (a), like the proposal,
requires that the CPDM be capable of
measuring respirable dust within the
personal breathing zone of the miner
whose exposure is being monitored. The
breathing zone is generally considered
to be the area surrounding the worker’s
nose and mouth. This zone is pictured
by drawing a sphere with a 10-inch
radius which is centered on the nose.
Current industrial hygiene principles
accept breathing zone samples as most
representative of the atmosphere to
which workers are exposed.8 MSHA did
not receive any comments on the
proposal.
Final paragraph (b), like the proposal,
provides requirements for the
measurement accuracy of the CPDM.
MSHA did not receive any comments on
the proposal.
Final paragraph (b)(1), like the
proposal, requires for full-shift
measurements of 8 hours or more, a 95
percent confidence that the recorded
measurements are within ±25 percent of
the true dust concentration, as
determined by CMDPSU reference
measurements, over a concentration
range from 0.2 to 4.0 mg/m3. The
specific degree of accuracy required is
based on the current state of the
technology of direct-reading monitors
and on the need for reasonable accuracy
6 Kennedy, E. R., T.J. Fischbach, R. Song, P.M.
Eller, and S.A. Shulman, 1995. Guidelines for air
sampling and analytical method development and
evaluation, DHHS (NIOSH) Publication No. 95–117.
7 Volkwein, J.C., R.P. Vinson, S.J. Page, L.J.
McWilliams, G.J. Joy. S.E. Mischler and D.P.
Tuchman. Laboratory and field performance of a
continuously measuring personal respirable dust
monitor. CDC RI 9669. September 2006. 47 pp. and
Volkwein, J. C., R.P. Vinson, L.J. McWilliams, D.P.
Tuchman, and S.E. Mischler. Performance of a New
Personal Respirable Dust Monitor for Mine Use.
CDC RI 9663. June 2004.
8 Guffy, S.E., M.E. Flanagan, G. VanBelle. Air
Sampling at the chest and ear as representative of
the breathing zone. AIHAJ, 62:416–427, 2001, show
that ear locations are preferred and that dust
sources relative to sample position are important.
A NIOSH study on miners shows that the chest and
cap lamp positions are representative of exposures
at the miner’s nose (Vinson, R.P. and J. C.
Volkwein, Determining the Spatial Variability of
Personal Sampler Inlet Locations (in press) JOEH,
2007).
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in industrial hygiene assessments to
assure worker protection. NIOSH has
demonstrated the feasibility of this
accuracy requirement through testing of
the CPDM prototype.9
The concentration range of 0.2 to 4.0
mg/m3 over which the CPDM must
provide accurate measurements is also
based on current CPDM technology, as
represented by the pre-commercial
device. This technology requires a
minimum quantity of dust loading on
the microbalance filter before the CPDM
can provide an accurate measurement.
This allows the CPDM to distinguish
actual exposure quantities from small
measurement variations due to
imperfections of the CPDM equipment.
The lower range of dust concentration
levels tested (0.2 mg/m3) assures that
accuracy is maintained for situations
where the quartz content in the mine
environment exceeds 5 percent causing
the PEL to be reduced. Similarly, there
is an upper bound of dust loading,
which is likely to exceed the
concentration level of 4.0 mg/m3,10
specified in the final rule. Above this
concentration level the current CPDM
technology may lose sensitivity as a
result of the heavily loaded filter on the
microbalance. The Agencies are
confident that the final rule will assure
that the range of end-of-shift average
dust concentrations over which the
CPDM must provide accurate
measurements will be adequate to
quantify actual full-shift exposures that
may range from exceptionally low to
exceptionally high concentrations.
MSHA did not receive any comments on
the proposal.
For intra-shift measurements of less
than 8 hours, final paragraph (b)(2), like
the proposal, requires a 95 percent
confidence that the recorded
measurements are within ±25 percent of
the true dust concentration, as
determined by CMDPSU reference
measurements, over the dust
concentration range equivalent to 0.2 to
4.0 mg/m3 for an 8-hour period. This
provision includes a formula for
calculating the equivalent dust
concentration range for assessing
accuracy of intra-shift measurements.
MSHA did not receive any comments on
the proposal.
9 Volkwein, J.C., R.P. Vinson, L.J. McWilliams,
D.P. Tuchman, and S.E. Mischler. Performance of
a New Personal Respirable Dust Monitor for Mine
Use. CDC RI 9663. June 2004.
10 NIOSH testing of the CPDM prototype used 4.0
mg/m3 dust concentration as the upper limit in
challenging the device for accuracy. NIOSH did not
conduct testing to identify the actual upper limit at
which the accuracy of the prototype would be
degraded below the testing standard, although the
ultimate occurrence of such degradation is
predictable based on engineering principles.
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Final paragraph (c), like the proposal,
requires the CPDM to meet the accuracy
requirements of the final rule regardless
of the variation in density, composition,
size distribution of respirable coal mine
dust particles, and presence of spray
mist in coal mines. Some monitoring
devices, such as light scattering
detectors, use technologies that have
potential for monitoring aerosol dust
concentrations. These devices currently
lack the ability to distinguish
differences in density and composition
of coal mine dust particles and other
aerosols in the mine, or to accommodate
variation in the coal mine dust particle
distribution. To be effective, the CPDM
must produce accurate measurements
for any coal mine atmosphere. MSHA
did not receive any comments on the
proposal.
Final paragraph (d), like the proposal,
requires that the CPDM monitor with
sufficient precision. Under the final
rule, precision must be established
through testing to determine the degree
to which the CPDM is able to closely
replicate multiple concentration
measurements when sampling identical
dust concentrations. The precision
requirement is a relative standard
deviation of less than 0.1275 without
bias for multiple measurements. It will
enable MSHA and mine operators to
monitor changes in dust concentrations
with reasonable confidence. MSHA did
not receive any comments on the
proposal.
Final paragraph (e), like the proposal,
requires the bias of CPDM
measurements to be limited such that
the uncorrectable discrepancy between
the mean of the distribution of
measurements and the true dust
concentration being measured during
testing be no greater than 10 percent. It
also requires that measurement bias be
constant over the range of dust
concentration levels tested, between 0.2
to 4.0 mg/m3, for an 8-hour sampling
period. This requirement assures that
the CPDM does not consistently either
overestimate or underestimate
respirable coal mine dust concentrations
to a substantial degree. This provides
further assurance of the accuracy of the
CPDM with respect to multiple
measurements. MSHA did not receive
any comments on the proposal.
Final paragraph (f), like the proposal,
requires applicants to use the NIOSH
testing procedure ‘‘Continuous Personal
Dust Monitor Accuracy Testing,’’ June
23, 2008, to evaluate the accuracy,
reliability, precision, and bias of a
CPDM. The NIOSH procedure is
incorporated by reference. The
procedure is available at the NIOSH
Web site: https://www.cdc.gov/niosh/
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mining/pubs/pubreference/
outputid3076.htm. The procedure
requires that testing be performed under
diverse environmental conditions and
that test results be submitted, in writing,
to NIOSH. The protocol assures that all
CPDMs are evaluated consistently.
NIOSH will provide assistance to
applicants, as necessary, to make the
arrangement of such testing feasible.
MSHA did not receive any comments on
the proposal.
I. § 74.9 Quality Assurance
Final § 74.9, like the proposal,
establishes new quality assurance
requirements for CPDM manufacturers.
Final paragraph (a), like the proposal,
requires the applicant to establish and
maintain a quality control system that
assures devices produced under the
applicant’s certificate of approval meet
the specifications to which they are
certified under this part and are reliable,
safe, effective, and otherwise fit for their
intended use. The quality control
system must meet the specifications in
ISO Q9001–2000 standard established
by the ISO.11 The ISO standard is
incorporated by reference. This
consensus standard for quality
management is in widespread use in
U.S. and international manufacturing
and service industries. It requires a
comprehensive quality management
system, which is essential for the
manufacture of sophisticated technical
equipment used in worker safety and
health.
Final paragraph (a), like the proposal,
also requires the applicant to submit a
copy of the most recent registration
under ISO Q9001–2000 to NIOSH,
together with the application and,
subsequent to an approval, upon
request. Registration under ISO Q9001–
2000, American National Standard,
Quality Management SystemsRequirements, will be considered
evidence of compliance with the ISO
Q9001–2000 standard. NIOSH considers
registration under the ISO quality
management standard as evidence that
the applicant has established a sound
quality assurance program. The
registration will allow the applicant to
use existing and widely available
independent auditing services. MSHA
did not receive any comments on the
proposal.
Final paragraph (b), like the proposal,
requires applicants or approval holders
to allow NIOSH to conduct quality
11 ISO Q9001:2000 is the International Standard:
Quality management systems—Requirements, 3rd
edition, approved on December 15, 2000 and
available from the International Organization for
Standardization and the American National
Standards Institute.
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management audits when requested or
in response to quality-related
complaints. NIOSH has similar
authority under its respirator
certification program (42 CFR part 84),
which has been used to assure product
quality in the respirator market. This
audit authority is essential in the event
of substantial quality management
problems in the manufacture of CPDMs.
MSHA did not receive any comments on
the proposal.
Final paragraph (c), like the proposal,
requires the applicant or approval
holder to correct any quality
management deficiencies identified by
NIOSH or an independent audit within
a reasonable time as determined by
NIOSH. The final rule also provides that
failure to correct a deficiency may result
in the disapproval of a pending
application or revocation of an existing
approval until such time as NIOSH has
determined that the deficiency is
corrected. NIOSH has similar authority
under its respirator certification
program, although NIOSH has rarely
had to employ it. MSHA did not receive
any comments on the proposal.
J. § 74.10 Operating and Maintenance
Instructions
Final § 74.10(a), like the proposal,
requires the manufacturer to include
operating and storage instructions and
maintenance and service life plan with
each new CPDM sold.
A commenter suggested that the
proposal provide more specific and
objective criteria so that anybody in the
industry can, after reading them, operate
the CPDM. In response to this
commenter’s suggestion, final § 74.10(a)
has been changed from the proposal to
include a new requirement in paragraph
(a)(iv) that the operating instructions
include a one page ‘‘quick start guide’’
that will enable a novice to start and
operate the CPDM. Except for
renumbering, all other provisions
remain the same.
Final paragraph (b), like the proposal,
is new and requires the manufacturer to
submit the instructions and plan under
paragraph (a) to NIOSH with the
application for approval. It also requires
that instructions and the plan be
submitted if any substantive changes are
made to the approved device or the
approved instructions. Adequate
instructions must be provided to
facilitate effective use of sophisticated
monitoring equipment. NIOSH review
and approval of instructions serves an
important final quality control function
for the manufacturer and assures that
instructions are clearly written and
easily understood. NIOSH has similar
authority under its respirator
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certification program (42 CFR part 84).
MSHA did not receive any comments on
the proposal.
K. § 74.11
Tests of the CPDM
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Final § 74.11 establishes new testing
requirements for evaluation of CPDMs.
Final paragraph (a), like the proposal,
requires the applicant to conduct all
testing specified in §§ 74.7–74.8 of this
part, with the exception of durability
testing under § 74.7(g). It further
requires that the testing be performed by
an independent testing entity approved
by NIOSH. This requirement provides
reasonable assurance of the quality of
testing and the reliability of test results.
MSHA did not receive any comments on
the proposal.
Final paragraph (b), like the proposal,
provides for NIOSH to assist the
applicant in identifying appropriate
testing services. It also requires that
applicants submit testing protocols to
NIOSH prior to testing so that NIOSH
can verify their adequacy. It is unlikely
that an applicant would be familiar with
testing resources capable of addressing
every element of the final rule. NIOSH
will be able to provide the applicant
with information on private and
university laboratories available for
testing. In addition, NIOSH review of
testing protocols will minimize the
possibility of inadequate testing, which
might result in the applicant incurring
unnecessary delay and costs. MSHA did
not receive any comments on the
proposal.
Final paragraph (c), like the proposal,
requires the applicant to arrange for the
independent testing entity to report
testing protocols and results directly to
NIOSH. This direct reporting
relationship between the testing entity
and NIOSH further establishes the
independence of the applicant from the
testing. MSHA did not receive any
comments on the proposal.
Final paragraph (d), like the proposal,
requires the applicant to submit the
CPDM to MSHA for testing and
evaluation to determine the intrinsic
safety of a CPDM submitted for
approval. MSHA conducts all intrinsic
safety testing for mining equipment
used in underground coal mines. A
CPDM that does not pass intrinsic safety
testing will not be approved for use in
coal mines. MSHA did not receive any
comments on the proposal.
Subpart D—General Requirements for
All Devices
L. § 74.12 Conduct of Tests;
Demonstrations
Final § 74.12, like the proposal,
addresses procedures for conducting
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tests, and renumbers and makes
clarifying changes to the existing
provision. This section concerns the
management of testing information prior
to and after the issuance of a certificate
of approval.
Final paragraph (a), like the proposal,
requires MSHA and NIOSH to continue
the existing practice of not disclosing
details of applicant’s drawings or
product specifications or other related
materials.
Final paragraph (b), like the proposal,
clarifies that after issuing a certificate of
approval, MSHA and NIOSH may reveal
test protocols and results considered for
approval of the CPDM. It provides for
the Agencies to protect disclosure of
this information to the fullest extent,
consistent with the Freedom of
Information Act. MSHA did not receive
any comments on the proposal.
M. § 74.13
Applications
Final § 74.13 substantively the same
as the proposal, addresses requirements
for filing an application for approval of
a coal mine dust sampling device. Final
paragraph (a), like the proposal, requires
the submission of an application in
duplicate to both NIOSH and MSHA for
approval of a CMDPSU. It also requires
that 10 complete CMDPSUs be
submitted to NIOSH and one pump be
sent to MSHA for testing. This provision
is the same as the existing requirement
for the CMDPSU. MSHA did not receive
any comments on the proposal.
Final paragraph (b), like the proposal,
requires the submission of an
application in duplicate to both NIOSH
and MSHA. It also requires that three
complete CPDMs be submitted to
NIOSH and one to MSHA. The
submitted devices will be used by
NIOSH to evaluate compliance with the
design and construction requirements,
verify any testing results, evaluate the
use and maintenance instructions, and
address quality assurance matters. The
device sent to MSHA will undergo
intrinsic safety testing. MSHA did not
receive any comments on the proposal.
Final paragraph (c), like the proposal,
requires that drawings and
specifications provided in the
application must be detailed to identify
the design of the CMDPSU or its pump
unit or CPDM and disclose the
dimension, and materials of all
component parts. This information is
necessary for a complete evaluation of
compliance with design and
construction requirements in the final
rule. MSHA did not receive any
comments on the proposal.
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N. § 74.14
Certificate of Approval
Final § 74.14, like the proposal,
specifies the procedures that NIOSH
and MSHA will use to approve or
disapprove an application for a
CMDPSU or CPDM. MSHA did not
receive any comments on the proposal.
O. § 74.15
Approval Labels
Final § 74.15, like the proposal,
specifies labeling procedures and other
requirements for the applicant. MSHA
did not receive any comments on the
proposal.
P. § 74.16
Record
Material Required for
Final § 74.16, like the proposal,
addresses requirements for a permanent
record of each application, the return of
CMDPSU or CPDM test devices to the
applicant, and the delivery of a
commercially produced device to
NIOSH. MSHA did not receive any
comments on the proposal.
Q. § 74.17
Changes After Certification
Final § 74.17, like the proposal,
includes procedures which the
applicant must follow to change features
of an approved CMDPSU or CPDM. This
provision requires the applicant to file
an application to change any feature and
to test the modified device if NIOSH
determines that testing is required.
MSHA did not receive any comments on
the proposal.
R. § 74.18
Withdrawal of Certification
Final § 74.18, like the proposal,
authorizes NIOSH or MSHA to revoke
for cause any certificate of approval for
a CMDPSU or CPDM. MSHA did not
receive any comments on the proposal.
IV. Regulatory Economic Analysis
A. Executive Order 12866
Under Executive Order (E.O.) 12866
(58 FR 51735), as amended by Executive
Order 13258 (amending Executive Order
12866 on Regulatory Planning and
Review (67 FR 9385)), the Agency must
determine whether a regulatory action is
‘‘significant’’ and subject to review by
the Office of Management and Budget
(OMB) and the requirements of the
Executive Order. Under section 3(f), the
order defines a ‘‘significant regulatory
action’’ as an action that is likely to
result in a rule (1) Having an annual
effect on the economy of $100 million
or more, or adversely and materially
affecting a sector of the economy,
productivity, competition, jobs, the
environment, public health or safety, or
State, local, or Tribal governments or
communities (also referred to as
‘‘economically significant’’); (2) creating
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serious inconsistency or otherwise
interfering with an action taken or
planned by another agency; (3)
materially altering the budgetary
impacts of entitlements, grants, user
fees, or loan programs or the rights and
obligations of recipients thereof; or (4)
raising novel legal or policy issues
arising out of legal mandates, the
President’s priorities, or the principles
set forth in this Executive Order. MSHA
has determined that the final rule does
not have an annual effect of $100
million or more on the economy and, is
not an economically ‘‘significant
regulatory action’’ pursuant to section
3(f) of Executive Order 12866. MSHA,
however, has concluded that the final
rule is otherwise significant under
Executive Order 12866 because it raises
novel legal or policy issues.
This final rule updates existing
requirements for the approval of a coal
mine dust personal sampler unit
(CMDPSU) to reflect the current state of
this technology. The current approval
holder of this device has voluntarily
incorporated the improved requirements
in the final rule into the device. The
final rule also includes procedures and
requirements by which NIOSH and
MSHA could approve a new monitoring
technology, continuous personal dust
monitor (CPDM), for use in coal mines.
Providing requirements to allow the
approval of a new monitoring
technology, the CPDM, for use in coal
mines, does not have any potential for
adversely impacting the economy.
Although there is a commercial version
of the CPDM available for use by the
mining industry, the final rule does not
address matters related to its use in coal
mines. It only addresses the
performance requirements for the
approval of CPDM devices.
B. Benefits
MSHA received no comments on the
Agency’s benefits analysis concerning
the approval of the CPDM. The only
comments received regarding benefits
pertained to the use of the CPDM, which
is not a subject of this rulemaking.
Therefore, the Agency is retaining the
benefits analysis used for the proposal.
Respirable coal mine dust is produced
when material is extracted from the coal
seam by drilling, blasting, and cutting,
and during loading and transporting of
that material from the mine. It consists
of a mixture of very small particles of
coal, silica, and other mineral and
organic materials found in the mine
environment that can be inhaled and
deposited in the lungs. It presents a
significant health hazard if not
adequately controlled. Long-term
exposure to excessive levels of
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respirable coal mine dust causes coal
workers’ pneumoconiosis (CWP) and
other occupational lung diseases like
chronic obstructive pulmonary disease
(COPD) which are collectively known as
‘‘black lung.’’ Overexposure to respirable
silica dust can lead to silicosis. These
occupational lung diseases can
devastate a miner’s quality of life, create
a heavy burden on the victim and the
victim’s family, and in some cases lead
to premature death.
The existing approved dust sampler
used by coal mine operators and MSHA
consists of a person-wearable batterypowered pump that draws mine air
through a cyclone that separates
respirable dust that can enter the inner
lung and deposits it on a filter that is
then weighed by MSHA. The dust
concentration is calculated based on the
volume of air sampled and the mass of
dust collected. Usually, this procedure
takes several days before mine operators
and MSHA receive the results. The final
rule updates application requirements
for the existing coal mine dust sampling
device to reflect design improvements
incorporated voluntarily by the
manufacturer since the mid 1990s.
Updating the CMDPSU application
requirements will ensure that any new
manufacturer entering the market will
produce a sampling device that reflects
currently-used technology.
The CPDM represents an innovative
technology that provides real-time and
continuous accurate measurement of
respirable coal mine dust during a
working shift. Continuous exposure
readings enable mine management to be
proactive and take immediate
preventive action to avoid potentially
excessive exposures. The devices can
also be used as an engineering tool to
permit the operator to rapidly evaluate
the effectiveness of various dust control
strategies.
MSHA and NIOSH recognize that
benefits derived from real-time
continuous monitoring will occur when
monitoring devices with this new
technology and strategies for their use
are developed and implemented.
However, before CPDMs can be
introduced in coal mines, they must be
approved for use by MSHA and NIOSH.
The existing regulations limit approval
to dust sampling devices of the current
design and do not permit the Agencies
to approve other technologically
advanced sampling devices that are
capable of monitoring dust
concentrations on a real-time and
continuous basis.
In summary, the final rule
incorporates requirements for approval
of the CPDM and includes improved
requirements for the CMDPSU.
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17521
C. Compliance Costs
MSHA received no comments on the
Agency’s proposed cost analysis
concerning the cost of approving coal
mine dust sampling devices. Similar to
the comments on benefits, the only
comments that MSHA received
regarding costs pertained to the use of
the CPDM, which is not a subject of this
rulemaking. The Agency is therefore
retaining the analysis used for the
proposal. Further, due to the small
magnitude of the costs, the Agency has
not prepared a separate regulatory
economic analysis. All cost estimates
are, therefore, included in this final
rule.
There is only one manufacturer of the
CMDPSU currently approved for use in
coal mines. No new applications for
approval have been received in over 30
years. The final rule, which updates the
design requirements for the CMDPSU,
does not require this manufacturer to
submit an application for a new
approval or any additional information
to MSHA and NIOSH. The CMDPSU
approved under existing requirements
already meets the final rule’s updated
requirements.
MSHA and NIOSH are aware of only
one manufacturer capable of mass
producing a CPDM that could be
submitted for approval under this final
rule. The Agencies believe that very few
instrument manufacturers have the
capacity or interest to develop
technology suitable for directly and
continuously measuring concentrations
of respirable coal mine dust in mine
atmospheres. The CPDM required a
Federal investment of approximately
$5.3 million, an additional private
investment of approximately $750,000,
and more than four years of
development before a suitable device
could be produced that could accurately
measure respirable dust concentrations
in coal mine atmospheres. It is likely
that few, if any, firms would undertake
this substantial level of research and
development given the limited market
for such a product.
Consequently, MSHA and NIOSH
expect that in the first year under the
final rule, there would be one
manufacturer filing an application
seeking approval of a CPDM. The cost
of the final rule in the first year is
estimated to be $293,000. The first year
approval costs are annualized over an
infinite time period by using a 7 percent
discount factor 12 that results in a cost
12 The 7 percent discount rate was obtained from
the Office of Management and Budget (OMB)
Circular A–4, issued September 17, 2003. The 7
percent rate is an estimate of the average before-tax
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of approximately $20,500 ($293,000 ×
0.07). The $293,000 consists of
approximately: $250,000 for the
applicant to have tests performed on the
CPDM by a third party (under final
§§ 74.7 and 74.8); $9,500 for MSHA to
evaluate and test the CPDM for intrinsic
safety (under proposed § 74.11); $3,200
for the applicant to file an application
for approval of the CPDM (under final
§ 74.13); and $30,000 for the cost of the
three CPDMs retained by NIOSH and
MSHA (under final §§ 74.16(a) and (b)).
The final rule costs are detailed below.
Final §§ 74.7 and 74.8 require tests
that the applicant must have performed
by a third party. These tests are for:
ergonomic design (under final § 74.7(b));
environmental conditions (under final
§ 74.7(e)); electromagnetic interference
(under final § 74.7(f)); flow stability and
calibration of pump (under final
§ 74.7(j)); and accuracy testing which
includes reliability measurement,
precision, and bias testing (under final
§§ 74.8(c), (d), and (e)). MSHA estimates
that it would cost the applicant
approximately $250,000 to conduct the
tests that are required by final §§ 74.7
and 74.8. The annualized cost is
$17,500 ($250,000 × 0.07).
Final § 74.11 requires that the
applicant submit the CPDM to MSHA
for testing and evaluation, under 30 CFR
§ 18.68, to determine whether the
electronic components of the CPDM
submitted for approval meet the
applicable permissibility requirements.
The following tests will be performed by
MSHA under § 18.68(a)(1): Current
limiting resistor adequacy test; coal dust
thermal ignition test; optical isolator
test; impact test and force test of
encapsulated electrical assemblies; drop
testing intrinsically safe apparatus;
mechanical test of partitions;
piezoelectric device impact test; and
dielectric strength test. The battery flash
current test will be performed under
§§ 18.68(a)(1) and (b)(1). The methane
thermal ignition test will be performed
under §§ 18.68(a)(1) and (b)(6). The
maximum surface temperature test will
be performed under § 18.68(a)(1) and
(b)(3). The spark ignition test will be
performed under §§ 18.68(a)(1), (a)(2),
(a)(4), (a)(5), (b)(4), and (b)(5).
MSHA estimates that it will take an
average of 45 hours to evaluate and 40
hours to test each application. MSHA
charges an hourly fee of $84 per hour for
evaluation and testing time. In addition,
MSHA applies a support factor of 1.617
to cover the administrative, clerical and
rate of return to private capital in the U.S. economy.
It is a broad measure that reflects the returns to real
estate and small business capital as well as
corporate capital.
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technical support services involved in
evaluating an application. Thus, the cost
for MSHA evaluation and testing is
approximately $9,500 [(45 hrs. × $84 ×
1.617) + (40 hrs. × $84)]. The annualized
cost is approximately $700 ($9,500 ×
0.07).
Final § 74.13(b) requires that a written
application for approval be submitted to
MSHA and NIOSH in duplicate. MSHA
estimates that it takes an engineer,
earning $74.32 per hour, a total of 40
hours to prepare and compile the
materials needed to accompany an
application. MSHA estimates that it
takes a clerical employee, earning
$26.37 per hour, 0.25 hours (15
minutes) to copy an application,
averaging 250 pages, at $0.15 per page.
The postage cost per application is
estimated to be $5. Thus, the cost to file
an application is estimated at $3,200 [(1
application × 40 hrs. × $74.32 per hr.)
+ (0.25 hrs. × $26.37 per hour × 4
copies) + (250 pages × $0.15 cost per
page × 4 copies) + ($5 × 4 copies)]. The
annualized cost is approximately $200
($3,200 × 0.07).
Final § 74.16(a) requires that MSHA
and NIOSH each retain one CPDM that
is submitted with the application. In
addition, final § 74.16(b) requires that
NIOSH receive one commercially
produced CPDM free of charge, if it is
approved by NIOSH and MSHA. MSHA
estimates that the cost of a CPDM could
range between $8,000 and $12,000 (for
an average of $10,000 per device). Thus,
the cost to provide two CPDMs with the
application and one subsequent to the
approval of the application is estimated
to be $30,000 (3 CPDMs × $10,000 per
CPDM). The annualized cost is $2,100
($30,000 × 0.07).
D. Economic and Technological
Feasibility
MSHA received no comments on the
feasibility analysis, and, is therefore
restating the feasibility analysis from the
proposed rule. Although the CPDM is a
new type of sampling device, the final
rule is technologically feasible. The
device has been developed and
successfully tested in underground coal
mines. This final rule puts in place the
necessary requirements to enable an
applicant to seek NIOSH and MSHA
approval of a CPDM for use in coal
mines. The one-time, first year cost to
obtain an approval for the CPDM is
estimated to be approximately $293,000.
MSHA concludes that the final rule is
economically feasible.
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V. Regulatory Flexibility Act and Small
Business Regulatory Enforcement
Fairness Act
Pursuant to the Regulatory Flexibility
Act (RFA) of 1980, as amended by the
Small Business Regulatory Enforcement
Fairness Act (SBREFA), MSHA has
analyzed the impact of the final rule on
small entities. Based on that analysis,
MSHA has notified the Chief Counsel
for Advocacy, Small Business
Administration, and made the
certification under the Regulatory
Flexibility Act at 5 U.S.C. 605(b) that
the final rule does not have a significant
economic impact on a substantial
number of small entities.
The final rule updates requirements
for the existing CMDPSU and
establishes procedures and
requirements for approving a new
technology, or CPDM, for use in coal
mines. A manufacturer of a CPDM
receiving an approval would be able to
market the device. The U.S. market
might also serve as a basis for marketing
the device internationally.
Currently, the new CPDM cannot be
approved because the existing design
specifications of 30 CFR Part 74 provide
for the approval of only one,
substantially different type of
technology, for monitoring
concentrations of respirable dust in coal
mine atmospheres. NIOSH’s evaluation
of the design and performance of the
CPDM has provided the empirical basis
for the approval requirements in the
final rule requirements. Accordingly,
MSHA has determined that this final
rule fosters the commercialization of the
CPDM.
Since the final rule does not impact
the manufacturer of the existing sampler
and permits the approval of the new
CPDM, MSHA concludes that it will not
have a significant economic impact on
a substantial number of small entities.
VI. Paperwork Reduction Act of 1995
The final rule will impose estimated
information collection requirements of
41 burden hours which are related to
filing approval applications required by
final § 74.13. This burden occurs in the
first year that the rule is in effect. MSHA
estimates that it takes an engineer 40
hours to compile the material for the
application, and a clerical employee 1
hour to prepare and send four copies of
the application (0.25 hours per
application × 4 copies). Two copies of
the application need to be sent to both
NIOSH and MSHA. Based on hourly
wage rates of $74.32 for an engineer and
$26.37 for a clerical employee, the
related burden costs are estimated to be
approximately $3,000 (40 hrs. × $74.32)
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+ (0.25 hrs. × $26.37 × 4 copies). The
final burden will be accounted for in
OMB control No. 1219–0066 which
contains the burden for applications
filed with MSHA that involve intrinsic
safety testing.
VII. Other Regulatory Considerations
A. The Unfunded Mandates Reform Act
of 1995
MSHA has reviewed the final rule
under the Unfunded Mandates Reform
Act of 1995 (2 U.S.C. 1501 et seq.).
MSHA has determined that this final
rule does not include any Federal
mandate that may result in increased
expenditures by State, local, or Tribal
governments; nor will it increase private
sector expenditures by more than $100
million in any one year or significantly
or uniquely affect small governments.
Accordingly, the Unfunded Mandates
Reform Act of 1995 (2 U.S.C. 1501 et
seq.) requires no further agency action
or analysis.
B. The Treasury and General
Government Appropriations Act of
1999: Assessment of Federal
Regulations and Policies on Families
C. Executive Order 12630: Government
Actions and Interference With
Constitutionally Protected Property
Rights
The final rule does not implement a
policy with takings implications.
Accordingly, E.O. 12630 requires no
further Agency action or analysis.
D. Executive Order 12988: Civil Justice
Reform
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The final rule was written to provide
a clear legal standard for affected
conduct and was carefully reviewed to
eliminate drafting errors and
ambiguities, so as to minimize litigation
and undue burden on the Federal court
system. Accordingly, the final rule
meets the applicable standards provided
in § 3 of E.O. 12988.
E. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
The final rule has no adverse impact
on children. Accordingly, E.O. 13045
requires no further Agency action or
analysis.
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The final rule does not have
‘‘federalism implications’’ because it
does 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, E.O. 13132, requires no
further Agency action or analysis.
G. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
The final rule does not have ‘‘Tribal
implications’’ because it does 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, E.O. 13175 requires, no
further Agency action or analysis.
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This final rule has no effect on family
well-being or stability, marital
commitment, parental rights or
authority, or income or poverty of
families and children. Accordingly,
§ 654 of the Treasury and General
Government Appropriations Act of 1999
(5 U.S.C. 601 note) requires no further
agency action, analysis, or assessment.
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F. Executive Order 13132: Federalism
Executive Order 13211 requires
agencies to publish a statement of
energy effects when a rule has a
significant energy action that adversely
affects energy supply, distribution, or
use. The final rule only addresses the
approval of coal mine dust sampling
devices. As stated previously, this rule
does not address their particular use in
coal mines. Therefore, the final rule
does not affect coal mines, nor does it
have a significant energy action that
adversely affects energy supply,
distribution, or use. Accordingly, MSHA
has concluded that the final rule is not
a ‘‘significant energy action’’ because it
is not ‘‘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, E.O. 13211
requires no further Agency action or
analysis.
I. Executive Order 13272: Proper
Consideration of Small Entities in
Agency Rulemaking
MSHA has reviewed the final rule to
assess and take appropriate account of
its potential impact on small businesses,
small governmental jurisdictions, and
small organizations. MSHA has
determined and certified that the final
rule does not have a significant
economic impact on a substantial
number of small entities.
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17523
List of Subjects in 30 CFR Part 74
Incorporation by reference, Mine
safety and health, Occupational safety
and health, Direct reading devices,
Monitoring technology.
Dated: March 29, 2010.
Joseph A. Main
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 as amended by the Mine
Improvement and New Emergency
Response Act of 2006, MSHA is
amending chapter I of title 30 of the
Code of Federal Regulations by revising
part 74 to read as follows:
■
PART 74—COAL MINE DUST
SAMPLING DEVICES
Subpart A—General
Sec.
74.1 Purpose.
74.2 Definitions.
Subpart B—Approval Requirements for
Coal Mine Dust Personal Sampler Unit
74.3 Sampler unit.
74.4 Specifications of sampler unit.
74.5 Tests of coal mine dust personal
sampler units.
74.6 Quality control.
Subpart C—Requirements for Continuous
Personal Dust Monitors (CPDMs)
74.7 Design and construction requirements.
74.8 Measurement, accuracy, and reliability
requirements.
74.9 Quality assurance.
74.10 Operating and maintenance
instructions.
74.11 Tests of the continuous personal dust
monitor.
Subpart D—General Requirements for All
Devices
74.12 Conduct of tests; demonstrations.
74.13 Applications.
74.14 Certificate of approval.
74.15 Approval labels.
74.16 Material required for record.
74.17 Changes after certification.
74.18 Withdrawal of certification.
Authority: 30 U.S.C. 957.
Subpart A—General
§ 74.1
Purpose.
The regulations in this part set forth
the requirements for approval of coal
mine dust sampling devices for
determining the concentrations of
respirable dust in coal mine
atmospheres; procedures for applying
for such approval; test procedures; and
labeling.
§ 74.2
Definitions.
(a) Accuracy: the ability of a
continuous personal dust monitor
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(CPDM) to determine the ‘‘true’’
concentration of the environment
sampled. Accuracy describes the
closeness of a typical measurement to
the quantity measured, although it is
defined and expressed in terms of the
relative discrepancy of a typical
measurement from the quantity
measured. The accuracy of a CPDM is
the theoretical maximum error of
measurement, expressed as the
proportion or percentage of the amount
being measured, without regard for the
direction of the error, which is achieved
with a 0.95 probability by the method.
(b) Bias: the uncorrectable relative
discrepancy between the mean of the
distribution of measurements from a
CPDM and the true concentration being
measured.
(c) Coal mine dust personal sampler
unit (CMDPSU): a personal device for
measuring concentrations of respirable
dust in coal mine atmospheres that
meets the requirements specified under
Subpart B of this part.
(d) Continuous personal dust monitor
(CPDM): a sampling device for
continuously measuring concentrations
of respirable dust in coal mine
atmospheres that reports within-shift
and end-of shift measurements of dust
concentrations immediately upon the
completion of the period of exposure
that was monitored and that meets the
requirements specified under Subpart C
of this part.
(e) ISO: the International Organization
for Standardization, an international
standard-setting organization composed
of representatives from various national
standards-setting organizations. ISO
produces industrial and commercial
voluntary consensus standards used
worldwide.
(f) Precision: the relative variability of
measurements from a homogeneous
atmosphere about the mean of the
population of measurements, divided by
the mean at a given concentration. It
reflects the ability of a CPDM to
replicate measurement results.
Subpart B—Approval Requirements for
Coal Mine Dust Personal Sampler Unit
§ 74.3
Sampler unit.
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A CMDPSU shall consist of:
(a) A pump unit,
(b) A sampling head assembly, and
(c) If rechargeable batteries are used in
the pump unit, a battery charger.
§ 74.4
Specifications of sampler unit.
(a) Pump unit:
(1) Dimensions. The overall
dimensions of the pump unit, hose
connections, and valve or switch covers
shall not exceed 4 inches (10
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centimeters) in height, 4 inches (10
centimeters) in width, and 2 inches (5
centimeters) in thickness.
(2) Weight. The pump unit shall not
weigh more than 20 ounces (567 grams).
(3) Construction. The case and all
components of the pump unit shall be
of sufficiently durable construction to
endure the wear of use in a coal mine,
shall be tight fitting to minimize the
amount of dust entering the pump case,
and shall be designed to protect against
radio frequency interference and
electromagnetic interference.
(4) Exhaust. The pump shall exhaust
into the pump case, maintaining a slight
positive pressure which will reduce the
entry of dust into the pump case.
(5) Switch. The pump unit shall be
equipped with an ON/OFF switch or
equivalent device on the outside of the
pump case. This switch shall be
protected against accidental operation
during use and protected to keep dust
from entering the mechanisms.
(6) Flow rate adjustment. Except as
provided in the last sentence of this
paragraph, the pump unit shall be
equipped with a suitable means of flow
rate adjustment accessible from outside
the case. The flow rate adjuster shall be
recessed in the pump case and protected
against accidental adjustment. If the
pump is capable of maintaining the flow
rate consistency required in this part
without adjustment, an external flow
rate adjuster is not required.
(7) Battery. The power supply for the
pump shall be a suitable battery located
in the pump case or in a separate case
which attaches to the pump case by a
permissible electrical connection.
(8) Pulsation. (i) The irregularity in
flow rate due to pulsation shall have a
fundamental frequency of not less than
20 Hz.
(ii) The quantity of respirable dust
collected with a sampler unit shall be
within ±5 percent of that collected with
a sampling head assembly operated with
nonpulsating flow.
(9) Belt clips. The pump unit shall be
provided with a belt clip which will
hold the pump securely on a coal
miner’s belt.
(10) Recharging connection. A
suitable connection shall be provided so
that the battery may be recharged
without removing the battery from the
pump case or from the battery case if a
separate battery case is used.
(11) Flow rate indicator. A visual
indicator of flow rate shall be provided
either as an integral part of the pump
unit or of the sampling head assembly.
The flow rate indicator shall be
calibrated within ±5 percent at 2.2, 2.0,
and 1.7 liters per minute to indicate the
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rate of air passing through the
accompanying sampling head assembly.
(12) Flow rate range. The pump shall
be capable of operating within a range
of from 1.5 to 2.5 liters per minute and
shall be adjustable over this range.
(13) Flow rate consistency. The flow
shall remain within ±0.1 liters per
minute over at least a 10-hour period
when the pump is operated at 2 liters
per minute with a standard sampling
head assembly.
(14) Flow restriction indicator. The
pump shall be capable of detecting
restricted flow and providing a visual
indication if it occurs. The flow
restriction indicator shall remain
activated until the cause is corrected.
The pump shall shut down
automatically if flow is restricted for
one minute.
(15) Duration of operation. The pump
with a fully charged battery pack shall
be capable of operating for (i) not less
than 8 hours at a flow rate of 2 liters per
minute against a resistance of 25 inches
(64 centimeters) of water measured at
the inlet of the pump; and (ii) for not
less than 10 hours at a flow rate of 2
liters per minute against a resistance of
15 inches (38 centimeters) of water
measured at the inlet of the pump.
(16) Low battery indicator. The pump
unit shall be equipped with a visual
indicator of low battery power.
(17) Elapsed time indicator. The
pump unit shall be capable of
displaying the actual pump run time in
minutes (up to 999 minutes) and
retaining the last reading after the pump
is shut down due to either a flow
restriction described in paragraph
(a)(14) of this section or low battery
power described in paragraph (a)(16) of
this section or at the end of the
sampling shift.
(b) Sampling head assembly. The
sampling head assembly shall consist of
a cyclone and a filter assembly as
follows:
(1) Cyclone. The cyclone shall consist
of a cyclone body with removable grit
cap and a vortex finder and shall be
constructed of nylon or a material
equivalent in performance. The
dimensions of the components, with the
exception of the grit cap, shall be
identical to those of a Dorr-Oliver 10
millimeter cyclone body, part No.
28541/4A or 01B11476–01 and vortex
finder, part No. 28541/4B.
(2) Filter assembly. The filter
assembly shall meet the following
requirements:
(i) Filter. The filter shall be a
membrane filter type with a nominal
pore size not over 5 micrometers. It
shall be nonhydroscopic and shall not
dissolve or decompose when immersed
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in ethyl or isopropyl alcohol. The
strength and surface characteristics of
the filter shall be such that dust
deposited on its surface may be
removed by ultrasonic methods without
tearing the filter. The filter resistance
shall not exceed 2 inches (0.5
centimeters) of water at an airflow rate
of 2 liters per minute.
(ii) Capsule. The capsule enclosing
the filter shall not permit sample air to
leak around the filter and shall prevent
visual inspection of the filter surface or
filter loading. The capsule shall be made
of nonhydroscopic material. Its weight,
including the enclosed filter, shall not
exceed 5 grams and it shall be preweighed by the manufacturer with a
precision of ± 0.001 milligrams. Impact
to the capsule shall not dislodge any
dust from the capsule, which might then
be lost to the weight measurement.
(iii) Cassette. The cassette shall
enclose the capsule so as to prevent
contamination and intentional or
inadvertent alteration of dust deposited
on the filter. The cassette must be easily
removable without causing a loss or
gain of capsule weight. The cassette
shall be designed to prevent
contaminants from entering or dust from
leaving the capsule when it is not in
use, and to prevent the reversal of
airflow through the capsule or other
means of removing dust collected on the
filter.
(3) Arrangement of components. The
connections between the cyclone vortex
finder and the capsule and between the
capsule and the 1⁄4-inch (0.64
centimeters) (inside diameter) hose
mentioned in paragraph (b)(5) of this
section shall be mechanically firm and
shall not leak at a rate of more than 0.1
liters per hour under a vacuum of 4
inches (10 centimeters) of water.
(4) Clamping of components. The
clamping and positioning of the cyclone
body, vortex finder, and cassette shall
be rigid, remain in alignment, be firmly
in contact and airtight. The cyclonecassette assembly shall be attached
firmly to a backing plate or other means
of holding the sampling head in
position. The cyclone shall be held in
position so that the inlet opening of the
cyclone is pointing perpendicular to,
and away from, the backing plate.
(5) Hose. A 3-foot (91 centimeter)
long, 1⁄4-inch (0.64 centimeters) (inside
diameter) clear plastic hose shall be
provided to form an airtight connection
between the inlet of the sampler pump
and the outlet of the filter assembly. A
device, capable of sliding along the hose
and attaching to the miner’s outer
garment, shall be provided.
(c) Battery charger.
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(1) Power supply. The battery charger
shall be operated from a 110 (VAC)
(nominal), 60 Hz power line.
(2) Connection. The battery charger
shall be provided with a cord and
polarized connector so that it may be
connected to the charge socket on the
pump or battery case.
(3) Protection. The battery charger
shall be fused, shall have a grounded
power plug, and shall not be susceptible
to damage by being operated without a
battery on charge.
(4) Charge rates. The battery charger
shall be capable of fully recharging the
battery in the pump unit within 16
hours.
§ 74.5 Tests of coal mine dust personal
sampler units.
(a) The National Institute for
Occupational Safety and Health
(NIOSH), Department of Health and
Human Services, shall conduct tests to
determine whether a CMDPSU that is
submitted for approval under these
regulations meets the requirements set
forth in § 74.4.
(b) The Mine Safety and Health
Administration (MSHA), Department of
Labor, will conduct tests and
evaluations to determine whether the
pump unit of a CMDPSU that is
submitted for approval under these
regulations complies with the
applicable permissibility provisions of
30 CFR 18.68.
§ 74.6
Quality control.
The applicant shall describe the way
in which each lot of components will be
sampled and tested to maintain its
quality prior to assembly of each
sampler unit. In order to assure that the
quality of the CMDPSU will be
maintained in production through
adequate quality control procedures,
MSHA and NIOSH reserve the right to
have their qualified personnel inspect
each applicant’s control-test equipment
procedures and records and to interview
the employees who conduct the control
tests. Two copies of the results of any
tests made by the applicant on the
CMDPSU or the pump unit thereof shall
accompany an application provided
under § 74.13 of this part.
Subpart C—Requirements for
Continuous Personal Dust Monitors
§ 74.7 Design and construction
requirements.
(a) General requirement. Continuous
Personal Dust Monitors (CPDMs) shall
be designed and constructed for coal
miners to wear and operate without
impeding their ability to perform their
work safely and effectively, and shall be
sufficiently durable to perform reliably
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in the normal working conditions of
coal mines.
(b) Ergonomic design testing. Prior to
submitting an application under § 74.13,
the applicant shall develop a testing
protocol and test the CPDM to assure
that the device can be worn safely,
without discomfort, and without
impairing a coal miner in the
performance of duties throughout a full
work shift. The results of the test shall
also demonstrate that the device will
operate consistently throughout a full
work shift under representative working
conditions of underground coal miners,
including representative types and
durations of physical activity, tasks, and
changes in body orientation.
(1) The testing protocol shall specify
that the tests be conducted in one or
more active mines under routine
operating conditions during production
shifts.
(2) The applicant shall submit the
testing protocol, in writing, to NIOSH
for approval prior to conducting such
testing.
(3) The applicant shall include the
testing protocol and written test results
in the application submitted to NIOSH
as specified in § 74.13.
(4) NIOSH will advise and assist the
applicant, as necessary, to develop a
testing protocol and arrange for the
conduct of testing specified in this
paragraph.
(5) NIOSH may further inspect the
device or conduct such tests as it deems
necessary to assure the safety, comfort,
practicality, and operability of the
device when it is worn by coal miners
in the performance of their duties.
(6) NIOSH may waive the requirement
for the applicant to conduct testing
under paragraph (b) of this section if
NIOSH determines that such testing is
unnecessary to assure the safety,
comfort, practicality, and operability of
the device when it is worn by coal
miners in the performance of their
duties.
(c) Maximum weight. A CPDM shall
not add more than 2 kg to the total
weight carried by the miner. CPDMs
that are combined with other functions,
such as communication or illumination,
may exceed 2 kg provided that the total
added weight carried by the miner does
not exceed 2 kg.
(d) Dust concentration range. The
CPDM shall measure respirable coal
mine dust concentrations accurately, as
specified under § 74.8, for an end-ofshift average measurement, for
concentrations within a range from 0.2
to 4.0 mg/m3 for respirable coal mine
dust. For end-of-shift average
concentrations exceeding 4.0 mg/m3,
the CPDM shall provide a reliable
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indication that the concentration
exceeded 4.0 mg/m3.
(e) Environmental conditions. The
CPDM shall operate reliably and
accurately as specified under § 74.8,
under the following environmental
conditions:
(1) At any ambient temperature and
varying temperatures from minus 30 to
plus 40 degrees centigrade;
(2) At any atmospheric pressure from
700 to 1000 millibars;
(3) At any ambient humidity from 10
to 100 percent relative humidity; and
(4) While exposed to water mists
generated for dust suppression and
while monitoring atmospheres
including such water mists.
(f) Electromagnetic interference. The
CPDM shall meet the following
standards for control of and protection
from electromagnetic interference.
(1) For emissions control, operators
must follow: IEEE Std C95.1–2005,
(IEEE Standard for Safety Levels with
Respect to Human Exposure to Radio
Frequency Electromagnetic Fields, 3
kHz to 300 GHz) and 47 CFR 15.1
through 15.407 (FCC Radio Frequency
Devices). Persons must proceed in
accordance with IEEE Std C95.1–2005
(IEEE Standard for Safety Levels with
Respect to Human Exposure to Radio
Frequency Electromagnetic Fields, 3
kHz to 300 GHz).
(i) The Director of the Federal Register
approves this incorporation by reference
in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. Persons may obtain a
copy from: American National
Standards Institute (ANSI), 25 West
43rd Street, New York, NY 10036.
https://www.ansi.org.
(ii) Persons may inspect a copy at
MSHA, Office of Standards,
Regulations, and Variances, 1100
Wilson Boulevard, Room 2350,
Arlington, Virginia 22209–3939, (202)
693–9440, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030, or go to: https://www.archives.gov/
federal_register/code_of_federal_
regulations/ibr_locations.html.
(2) For immunity/susceptibility
protection, operators must follow: IEC
61000–4–6, International Standard
(Electromagnetic compatibility—Part 4–
6: Testing and measurement
techniques—Immunity to conducted
disturbances, induced by radiofrequency fields), Edition 3.0, 2008–10.
Persons must proceed in accordance
with IEC 61000–4–6, International
Standard (Electromagnetic
compatibility—Part 4–6: Testing and
measurement techniques—Immunity to
conducted disturbances, induced by
radio-frequency fields), Edition 3.0,
Mil-Std-810F, 514.5 ..............................
Drop .......................
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Vibration .................
3-foot drop onto bare concrete surface
(1) Persons must proceed in
accordance with Mil-Std-810F, 514.5,
Department of Defense Test Method for
Environmental Engineering
Considerations and Laboratory Tests, 1
January 2000. The Director of the
Federal Register approves this
incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51. Persons may obtain a copy
from the U.S. Department of Defense at
the address provided below.
ASC/ENOI, Bldg. 560, 2530 Loop
Road West, Wright-Patterson AFB OH
45433–7101. https://www.dtc.army.mil/
navigator/.
(2) Persons may inspect a copy at
MSHA, Office of Standards,
Regulations, and Variances, 1100
Wilson Boulevard, Room 2350,
Arlington, Virginia 22209–3939, (202)
693–9440, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030, or go to: https://www.archives.gov/
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U.S. Highway Vibration, Restrained
Figure 514.5C–1.
In standard in-use configuration ...........
federal_register/code_of_federal_
regulations/ibr_locations.html.
(h) Reporting of monitoring results.
(1) The CPDM shall report continuous
monitoring results legibly or audibly
during use. A digital display, if used,
shall be illuminated and shall provide a
minimum character height of 6
millimeters. Other forms of display (e.g.,
analogue) must provide comparable
visibility. Auditory reporting, if used,
shall be clear, have adjustable volume,
and provide means for the user to obtain
data reports repetitively. The CPDM
shall also report end-of-shift results
using computer software compatible
with current, commonly used personal
computer technology.
(2) The CPDM shall report results as
cumulative mass concentration in units
of mass per volume of air (mg/m3) with
two significant figures of accuracy
rounded as customary.
(i) Power requirements. The power
source of the CPDM shall have sufficient
capacity to enable continuous sampling
for 12 hours in a coal mine dust
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2008–10. The Director of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51.
(i) Persons may obtain a copy from the
International Electrotechnical
Commission at the address provided
below:
International Electrotechnical
Commission, IEC Central Office, 3, rue
´
de Varembe, P.O. Box 131, CH–1211
GENEVA 20, Switzerland. https://
www.standardsinfo.net.
(ii) Persons may inspect a copy at
MSHA, Office of Standards,
Regulations, and Variances, 1100
Wilson Boulevard, Room 2350,
Arlington, Virginia 22209–3939, (202)
693–9440, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030, or go to: https://www.archives.gov/
federal_register/code_of_federal_
regulations/ibr_locations.html.
(g) Durability testing. The CPDM shall
be designed and constructed to remain
safe and measure respirable coal mine
dust concentrations accurately, as
specified under § 74.8 of this section
after undergoing the following
durability tests, which NIOSH will
apply to test devices prior to their use
in further testing under § 74.8 of thissubpart:
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1 Hours/Axis, 3 Axis; Total Duration =
3 Hrs, equivalent to 1,000 miles.
1 drop per axis (3 total).
atmosphere of up to 4.0 mg/m3. If the
CPDM uses a rechargeable battery, the
battery charger shall be operated from a
110 (VAC) (nominal), 60 Hz power line.
(j) Flow stability and calibration of
pump. If a pump is used, the flow shall
not vary more than ±5 percent of the
calibrated flow for 95 percent of
samples taken for any continuous
duration for up to 12 hours. The flow
calibration maintenance interval to
assure such performance shall be
specified in the calibration instructions
for the device.
(k) Battery check. If the CPDM uses a
rechargeable battery, the CPDM shall
have a feature to indicate to the user
that the device is sufficiently charged to
operate and provide accurate
measurements for an entire shift of 12
hours under normal conditions of use.
(l) Integration with other personal
mining equipment.
(1) If the CPDM is integrated or shares
functions with any other devices used
in mines, such as cap lights or power
sources, then the applicant shall obtain
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approvals for such other devices, prior
to receiving final certification of the
CPDM under this section.
(2) A CPDM that is integrated with
another device shall be tested, according
to all the requirements under this part,
with the other device coupled to the
CPDM and operating.
(m) Tampering safeguards or
indicators. The CPDM shall include a
safeguard or indicator which either
prevents intentional or inadvertent
altering of the measuring or reporting
functions or indicates that the
measuring or reporting functions have
been altered.
(n) Maintenance features. The CPDM
shall be designed to assure that the
device can be cleaned and maintained
to perform accurately and reliably for
the duration of its service life.
§ 74.8 Measurement, accuracy, and
reliability requirements.
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(a) Breathing zone measurement
requirement. The CPDM shall be
capable of measuring respirable dust
within the personal breathing zone of
the miner whose exposure is being
monitored.
(b) Accuracy. The ability of a CPDM
to determine the true concentration of
respirable coal mine dust at the end of
a shift shall be established through
testing that demonstrates the following:
(1) For full-shift measurements of 8
hours or more, a 95 percent confidence
that the recorded measurements are
within ± 25 percent of the true
respirable dust concentration, as
determined by CMDPSU reference
measurements, over a concentration
range from 0.2 to 4.0 mg/m3; and
(2) For intra-shift measurements of
less than 8 hours, a 95 percent
confidence that the recorded
measurements are within ± 25 percent
of the true respirable dust
concentration, as determined by
CMDPSU reference measurements, over
the concentration range equivalent to
0.2 to 4.0 mg/m3 for an 8-hour period.1
(c) Reliability of measurements. The
CPDM shall meet the accuracy
1 The equivalent dust concentration range to the
8-hour range of 0.2 ¥ 4 mg/m3 is calculated by
multiplying this 8-hour range by the dividend of
eight hours divided by the duration of the intrashift
measurement specified in units of hours. For
example, for a measurement taken at exactly one
hour into the shift, the 8-hour equivalent dust
concentration range would be a one-hour average
concentration range of: 8 hours/1 hour × (0.2 ¥ 4
mg/m3) = 1.6 ¥ 32 mg/m3; for a two-hour
measurement, the applicable concentration range
would be calculated as: 8 hours/2 hours × (0.2 ¥
4 mg/m3) = 0.8 ¥ 16 mg/m3; for a 4-hours
measurement, the equivalent range would be: 0.4
¥ 8 mg/m3; * * * etc. A CPDM must perform
accurately, as specified, for intrashift measurements
within such equivalent concentration ranges.
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requirements under paragraph (b) of this
section, regardless of the variation in
density, composition, size distribution
of respirable coal mine dust particles,
and the presence of water spray mist in
coal mines.
(d) Precision. The precision of the
CPDM shall be established through
testing to determine the variability of
multiple measurements of the same dust
concentration, as defined by the relative
standard deviation of the distribution of
measurements. The relative standard
deviation shall be less than 0.1275
without bias for both full-shift
measurements of 8 hours or more, and
for intra-shift measurements of less than
8 hours within the dust concentration
range equivalent to 0.2 to 4.0 mg/m3 for
an 8-hour period, as specified under
paragraph (b)(2) of this section.
(e) Bias. The bias of the CPDM
measurements shall be limited such that
the uncorrectable discrepancy between
the mean of the distribution of
measurements and the true dust
concentration being measured during
testing shall be no greater than 10
percent. Bias must be constant over the
range of dust concentration levels
tested, 0.2 to 4.0 mg/m3 for an 8-hour
sampling period.
(f) Testing conditions. Laboratory and
mine testing of the CPDM for accuracy,
precision, bias, and reliability under
diverse environmental conditions (as
defined under § 74.7(e) and (g)) shall be
determined using the NIOSH testing
procedure, ‘‘Continuous Personal Dust
Monitor Accuracy Testing,’’ June 23,
2008, available at: https://www.cdc.gov/
niosh/mining/pubs/pubreference/
outputid3076.htm. All testing results
shall be submitted to NIOSH in writing
on the application filed under § 74.11.
(1) Persons must proceed in
accordance with NIOSH testing
procedure ‘‘Continuous Personal Dust
Monitor Accuracy Testing,’’ June 23,
2008. The Director of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Persons may
obtain a copy at the address below:
NIOSH–Publications Dissemination,
4676 Columbia Parkway, Cincinnati, OH
45226. https://www.cdc.gov/niosh/
mining.
(2) Persons may inspect a copy at
MSHA, Office of Standards,
Regulations, and Variances, 1100
Wilson Boulevard, Room 2350,
Arlington, Virginia 22209–3939, (202)
693–9440, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030, or go to: https://www.archives.gov/
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§ 74.9
Quality assurance.
(a) General requirements. The
applicant shall establish and maintain a
quality control system that assures that
CPDM devices produced under the
applicant’s certificate of approval meet
the required specifications and are
reliable, safe, effective, and otherwise
suitable for their intended use. To
establish and to maintain an approval
under this part, the applicant shall:
(1) Submit a copy of the most recent
registration under ISO Q9001–2000,
American National Standard, Quality
Management Systems-Requirements,
published by ISO:
(i) With the application for approval
under § 74.13 of this part; and
(ii) Upon request by NIOSH,
subsequent to the approval of a CPDM
under this part.
(2) Persons must proceed in
accordance with ISO Q9001–2000,
American National Standard, Quality
Management Systems-Requirements.
The Director of the Federal Register
approves this incorporation by reference
in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. Persons may obtain a
copy from the International
Organization for Standardization at the
address provided below.
International Organization for
Standardization, ISO Central Secretariat,
1, ch. de la Voie-Creuse, Case Postale
56, CH–1211 GENEVA 20, Switzerland.
https://www.standardsinfo.net.
(3) Persons may inspect a copy at
MSHA, Office of Standards,
Regulations, and Variances, 1100
Wilson Boulevard, Room 2350,
Arlington, Virginia 22209–3939, (202)
693–9440, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030, or go to: https://www.archives.gov/
federal_register/code_of_federal_
regulations/ibr_locations.html.
(b) Quality management audits. Upon
request, applicants or approval holders
must allow NIOSH to inspect the quality
management procedures and records,
and to interview any employees who
may be knowledgeable of quality
management processes associated with
the production of the CPDM. Audits
may be conducted either on an
occasional or periodic basis or in
response to quality-related complaints
or concerns.
(c) Applicant remediation of quality
management deficiencies. An applicant
or approval holder must correct any
quality management deficiency
identified by an audit within a
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Federal Register / Vol. 75, No. 65 / Tuesday, April 6, 2010 / Rules and Regulations
reasonable time as determined by
NIOSH. Failure to correct a deficiency
may result in NIOSH disapproval of a
pending application or, in the case of an
approved device, revocation of approval
until NIOSH determines that the
deficiency is corrected.
§ 74.10 Operating and maintenance
instructions.
(a) Contents. The manufacturer must
include operating and storage
instructions and a maintenance and
service life plan with each new CPDM
device sold. These documents must be
clearly written.
(1) Operating and storage instructions
must include:
(i) An explanation of how the CPDM
works;
(ii) A schematic diagram of the CPDM;
(iii) Procedures for wearing and use of
the CPDM;
(iv) A one page ‘‘quick start guide’’
that will enable a novice to start and
operate the CPDM.
(v) Procedures for calibration of the
CPDM;
(vi) Procedures for inspecting the
operating condition of the CPDM;
(vii) Procedures and conditions for
storage, including the identification of
any storage conditions that would likely
impair the effective functioning of the
CPDM; and
(viii) Procedures and conditions of
use, including identification of any
conditions of use that would likely
impair the effective functioning of the
CPDM.
(2) The maintenance and service life
plan must address:
(i) Conditions that should govern the
removal from service of the CPDM; and
(ii) Procedures that a user or others
should follow when inspecting,
performing maintenance and
calibration, and determining when the
CPDM should be removed from service.
(b) Submission to NIOSH for
approval. A copy of the instructions and
plan under paragraph (a) of this section
shall be submitted to NIOSH with the
application for approval of the CPDM
and if substantive changes are made to
the approved device or approved
instructions.
erowe on DSKH9S0YB1PROD with RULES3
§ 74.11 Tests of the continuous personal
dust monitor.
(a) Applicant testing. The applicant
shall conduct tests to determine
whether a CPDM that is submitted for
approval under these regulations meets
the requirements specified in §§ 74.7–
74.8 of this part, with the exception of
durability testing, which shall be
conducted by NIOSH as specified in
§ 74.7(g) of this part. Applicant testing
VerDate Nov<24>2008
16:52 Apr 05, 2010
Jkt 220001
shall be performed by an independent
testing entity approved by NIOSH.
(b) NIOSH testing assistance. NIOSH
will provide consultation to the
applicant to identify and secure
necessary testing services for meeting
the requirements specified in §§ 74.7–
74.8 of this part. Applicants must
submit testing protocols to NIOSH prior
to testing to verify that the testing
protocols adequately address the
requirements.
(c) Reporting of applicant testing
results. The applicant shall include the
results from testing specified under
paragraph (a) of this section when
submitting the application under § 74.13
of this part to NIOSH.
(d) Intrinsic safety testing. The
applicant shall submit the CPDM to
MSHA for testing and evaluation,
pursuant to 30 CFR 18.68, to determine
whether the electronic components of
the CPDM submitted for approval meet
the applicable permissibility provisions.
Subpart D—General Requirements for
All Devices
§ 74.12
Conduct of tests; demonstrations.
(a) Prior to the issuance of a certificate
of approval, only personnel of MSHA
and NIOSH, representatives of the
applicant, and such other persons as
may be mutually agreed upon may
observe the tests conducted. MSHA and
NIOSH shall hold as confidential, and
shall not disclose, principles of
patentable features, nor shall MSHA or
NIOSH disclose any details of the
applicant’s drawings or specifications or
other related material.
(b) After the issuance of a certificate
of approval, MSHA or NIOSH will
conduct such public demonstrations
and tests of the approved device as
MSHA or NIOSH deem appropriate, and
may reveal the protocols and results of
testing considered for the approval of
the device. The conduct of any
additional investigations, tests, and
demonstrations shall be under the sole
direction of MSHA and NIOSH and any
other persons shall be present only as
observers.
§ 74.13
Applications.
(a) Testing of a CMDPSU will be
performed by NIOSH, and testing of the
pump unit of the CMDPSU will be
conducted by MSHA. The applicant
must submit a written application in
duplicate to both NIOSH and MSHA.
Each copy of the application must be
accompanied by complete scale
drawings, specifications, and a
description of materials. Ten complete
CMDPSUs must be submitted to NIOSH
PO 00000
Frm 00018
Fmt 4701
Sfmt 4700
with the application, and one pump
unit must be submitted to MSHA.
(b) Testing of a CPDM will be
performed by the applicant as specified
under § 74.11. The applicant must
submit a written application in
duplicate to both NIOSH and MSHA.
Each copy of the application must be
accompanied by complete scale
drawings, specifications, a description
of materials, and a copy of the testing
protocol and test results which were
provided by an independent testing
entity, as specified in § 74.11(a). Three
complete CPDM units must be sent to
NIOSH with the application, and one
CPDM device must be sent to MSHA.
(c) Complete drawings and
specifications accompanying each copy
of the application shall be fully detailed
to identify the design of the CMDPSU or
pump unit thereof or of the CPDM and
to disclose the dimensions and
materials of all component parts.
§ 74.14
Certificate of approval.
(a) Upon completion of the testing of
a CMDPSU or the pump unit or after
review of testing protocols and testing
results for the CPDM, NIOSH or MSHA,
as appropriate, shall issue to the
applicant either a certificate of approval
or a written notice of disapproval.
NIOSH will not issue a certificate of
approval unless MSHA has first issued
a certificate of approval for either the
pump unit of a CMDPSU or for the
CPDM. If a certificate of approval is
issued, no test data or detailed results of
tests will accompany such approval. If
a notice of disapproval is issued, it will
be accompanied by details of the
defects, resulting in disapproval, with a
view to possible correction.
(b) A certificate of approval will be
accompanied by a list of the drawings
and specifications covering the details
of design and construction of the
CMDPSU and the pump unit, or of the
CPDM, as appropriate, upon which the
certificate of approval is based. The
applicant shall keep exact duplicates of
the drawings and specifications
submitted to NIOSH and to MSHA
relating to the CMDPSU, the pump unit
thereof, or the CPDM, which has
received a certificate of approval. The
approved drawings and specifications
shall be adhered to exactly in the
production of the certified CMDPSU,
including the pump unit or of the
CPDM, for commercial purposes. In
addition, the applicant shall observe
such procedures for, and keep such
records of, the control of component
parts as either MSHA or NIOSH may in
writing require as a condition of
approval.
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Federal Register / Vol. 75, No. 65 / Tuesday, April 6, 2010 / Rules and Regulations
§ 74.15
Approval labels.
(a) Certificate of approval will be
accompanied by photographs of designs
for the approval labels to be affixed to
each CMDPSU or CPDM, as appropriate.
(b) The labels showing approval by
NIOSH and by MSHA shall contain
such information as MSHA or NIOSH
may require and shall be reproduced
legibly on the outside of a CMDPSU or
CPDM, as appropriate, as directed by
NIOSH or MSHA.
(c) The applicant shall submit fullscale designs or reproductions of
approval labels and a sketch or
description of the position of the labels
on each sampling device.
(d) Use of the approval labels
obligates the applicant to whom the
certificate of approval was issued to
maintain the quality of the complete
CMDPSU or CPDM, as appropriate, and
to guarantee that the complete CMDPSU
or CPDM, as appropriate, is
manufactured or assembled according to
the drawings and specifications upon
which the certificate of approval was
based. Use of the approval labels is
authorized only on CMDPSUs or
CPDMs, as appropriate, that conform to
the drawings and specifications upon
which the certificate of approval we
based.
§ 74.16
erowe on DSKH9S0YB1PROD with RULES3
§ 74.18
Withdrawal of certification.
Any certificate of approval issued
under this part may be revoked for
cause by NIOSH or MSHA which issued
the certificate.
[FR Doc. 2010–7308 Filed 4–5–10; 8:45 am]
BILLING CODE 4510–43–P
Material required for record.
(a) As part of the permanent record of
the approval application process,
NIOSH will retain a complete CMDPSU
or CPDM, as appropriate, and MSHA
will retain a CMDPSU or CPDM, as
appropriate, that has been tested and
certified. Material not required for
record purposes will be returned to the
applicant at the applicant’s request and
expense upon receipt of written
shipping instructions by MSHA or
NIOSH.
(b) As soon as a CMDPSU or CPDM,
as appropriate, is commercially
available, the applicant shall deliver a
complete sampling device free of charge
to NIOSH at the address specified on the
NIOSH Web page: https://www.cdc.gov/
niosh/mining.
§ 74.17
(2) The application and
accompanying material will be
examined by NIOSH to determine
whether testing of the modified
CMDPSU or CPDM or components will
be required. Testing will be necessary if
there is a possibility that the
modification may adversely affect the
performance of the CMDPSU or CPDM.
NIOSH will inform the applicant
whether such testing is required.
(3) If the proposed modification meets
the pertinent requirements of these
regulations, a formal extension of
certification will be issued,
accompanied by a list of new and
revised drawings and specifications to
be added to those already on file as the
basis for the extension of certification.
(b) If a change is proposed in a pump
unit of a certified CMDPSU or in
electrical components of a CPDM, the
approval of MSHA with respect to
intrinsic safety shall be obtained in
accordance with the procedures set
forth in § 74.11(d).
Changes after certification.
(a) If the applicant desires to change
any feature of a certified CMDPSU or a
certified CPDM, the applicant shall first
obtain the approval of NIOSH pursuant
to the following procedures:
(1) Application shall be made as for
an original certificate of approval,
requesting that the existing certification
be extended to encompass the proposed
change. The application shall be
accompanied by drawings,
specifications, and related material.
VerDate Nov<24>2008
16:52 Apr 05, 2010
Jkt 220001
DEPARTMENT OF LABOR
Mine Safety and Health Administration
30 CFR Parts 18 and 75
RIN 1219–AB34
High-Voltage Continuous Mining
Machine Standard for Underground
Coal Mines
AGENCY: Mine Safety and Health
Administration, Labor.
ACTION: Final rule.
SUMMARY: This final rule revises the
Mine Safety and Health
Administration’s (MSHA’s) electrical
safety standards for the installation, use,
and maintenance of high-voltage
continuous mining machines in
underground coal mines. It also revises
MSHA’s design requirements for
approval of these mining machines. The
final rule will allow mine operators to
use high-voltage continuous mining
machines with enhanced safety
protection against fires, explosions, and
shock hazards and will facilitate the use
of advanced equipment designs.
DATES: The final rule is effective on June
7, 2010. The incorporation by reference
in this rule is approved by the Director
PO 00000
Frm 00019
Fmt 4701
Sfmt 4700
17529
of the Federal Register as of June 7,
2010.
FOR FURTHER INFORMATION CONTACT:
Patricia W. Silvey, Director, Office of
Standards, Regulations, and Variances,
MSHA, 1100 Wilson Boulevard, Room
2350, Arlington, Virginia 22209–3939.
Ms. Silvey can be reached at
silvey.patricia@dol.gov (e-mail), 202–
693–9440 (voice), or 202–693–9441
(facsimile). (These are not toll-free
numbers.)
The
outline of this final rule is as follows:
SUPPLEMENTARY INFORMATION:
I. Introduction
A. Background
B. Petition for Modification (PFM)
Requirements in the Final Rule
II. Discussion of the Final Rule
A. General Discussion—Part 18—Electric
Motor-Driven Mine Equipment and
Accessories
B. General Discussion—Part 75—
Mandatory Safety Standards—
Underground Coal Mines
III. Section-by-Section Analysis
A. Part 18—Electric Motor-Driven Mine
Equipment and Accessories
B. Part 75—Mandatory Safety Standards—
Underground Coal Mines
IV. Executive Order 12866: Regulatory
Planning and Review
A. Population at Risk
B. Benefits
C. Compliance Costs
V. Feasibility
A. Technological Feasibility
B. Economic Feasibility
VI. Regulatory Flexibility Act (RFA) and
Small Business Regulatory Enforcement
Fairness Act (SBREFA)
A. Definition of a Small Mine
B. Factual Basis for Certification
VII. Paperwork Reduction Act of 1995
A. Elimination of Burden Hours
B. Annual Burden Hours
C. Details
VIII. Other Regulatory Considerations
A. The Unfunded Mandates Reform Act of
1995
B. Executive Order 13132: Federalism
C. The Treasury and General Government
Appropriations Act of 1999: Assessment
of Federal Regulations and Policies on
Families
D. Executive Order 12630: Government
Actions and Interference With
Constitutionally Protected Property
Rights
E. Executive Order 12988: Civil Justice
Reform
F. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
G. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
E:\FR\FM\06APR3.SGM
06APR3
]]>Agencies
[Federal Register Volume 75, Number 65 (Tuesday, April 6, 2010)]
[Rules and Regulations]
[Pages 17512-17529]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7308]
[[Page 17511]]
-----------------------------------------------------------------------
Part III
Department of Labor
-----------------------------------------------------------------------
Mine Safety and Health Adminisration
-----------------------------------------------------------------------
30 CFR Parts 18, 74, and 75
Coal Mine Dust Sampling Devices; High-Voltage Continuous Mining Machine
Standard for Underground Coal Mines; Final Rules
Federal Register / Vol. 75 , No. 65 / Tuesday, April 6, 2010 / Rules
and Regulations
[[Page 17512]]
-----------------------------------------------------------------------
DEPARTMENT OF LABOR
Mine Safety and Health Adminisration
30 CFR Part 74
RIN 1219-AB61
Coal Mine Dust Sampling Devices
AGENCY: Mine Safety and Health Administration, Labor.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule revises requirements that the Mine Safety and
Health Administration (MSHA) and the National Institute for
Occupational Safety and Health (NIOSH) use to approve sampling devices
that monitor miner exposure to respirable coal mine dust. The final
rule updates approval requirements for the existing ``coal mine dust
personal sampler unit'' to reflect improvements in this sampler over
the past 15 years. The final rule also establishes criteria for
approval of a new type of technology, the ``continuous personal dust
monitor,'' which is worn by the miner and will report dust exposure
levels continuously during the shift.
DATES: This final rule is effective June 7, 2010.
The incorporation by reference of certain publications listed in
the rule is approved by the Director of the Federal Register as of June
7, 2010.
FOR FURTHER INFORMATION CONTACT: Patricia W. Silvey, Director, Office
of Standards, Regulations, and Variances, MSHA, at
silvey.patricia@dol.gov (E-mail), (202) 693-9440 (voice), or (202) 693-
9441 (facsimile).
SUPPLEMENTARY INFORMATION: The outline of the final rule is as follows:
I. Introduction
A. Background
B. Rulemaking History
II. Summary of Final Rule
Subpart A--Introduction
III. Section-By-Section Analysis
A. Sec. 74.1 Purpose
B. Sec. 74.2 Definitions
Subpart B--Requirements for Coal Mine Dust Personal Sampler Unit
C. Sec. 74.3 Sampler Unit
D. Sec. 74.4 Specifications of Sampler Unit
E. Sec. 74.5 Tests of Coal Mine Dust Personal Sampler Units
F. Sec. 74.6 Quality Control
Subpart C--Requirements for Continuous Personal Dust Monitors
(CPDMs)
G. Sec. 74.7 Design and Construction Requirements
H. Sec. 74.8 Measurement, Accuracy, and Reliability
Requirements
I. Sec. 74.9 Quality Assurance
J. Sec. 74.10 Operating and Maintenance Instructions
K. Sec. 74.11 Tests of the Continuous Personal Dust Monitor
Subpart D--General Requirements for All Devices
L. Sec. 74.12 Conduct of Tests; Demonstrations
M. Sec. 74.13 Applications
N. Sec. 74.14 Certificate of Approval
O. Sec. 74.15 Approval Labels
P. Sec. 74.16 Material Required for Record
Q. Sec. 74.17 Changes After Certification
R. Sec. 74.18 Withdrawal of Certification
IV. Regulatory Economic Analysis
A. Executive Order 12866
B. Benefits
C. Compliance Costs
D. Economic and Technological Feasibility
V. Regulatory Flexibility Act and Small Business Regulatory
Enforcement Fairness Act
VI. Paperwork Reduction Act of 1995
VII. Other Regulatory Considerations
A. The Unfunded Mandates Reform Act of 1995
B. The Treasury and General Government Appropriations Act of
1999: Assessment of Federal Regulations and Policies on Families
C. Executive Order 12630: Government Actions and Interference
With Constitutionally Protected Property Rights
D. Executive Order 12988: Civil Justice Reform
E. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
F. Executive Order 13132: Federalism
G. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
I. Executive Order 13272: Proper Consideration of Small Entities
in Agency Rulemaking
I. Introduction
A. Background
The Coal Mine Health and Safety Act of 1969, the predecessor to the
Federal Mine Safety and Health Act of 1977, required each operator of a
coal mine to take accurate samples of the amount of respirable dust in
the mine atmosphere to which each miner in the active workings of such
mine is exposed. Samples had to be taken by a device approved by the
Secretary and the Secretary of Health, Education and Welfare
(Secretaries). MSHA's existing standards for joint approval of dust
sampling devices were issued in 1972. They specified that MSHA's role
was to determine whether the pump unit of a sampling device was
intrinsically safe, and that the National Institute for Occupational
Safety and Health (NIOSH) would determine whether the sampling device
met the requirements of part 74.\1\
---------------------------------------------------------------------------
\1\ In 1978, responsibility for mine safety and health was
transferred from the Department of Interior to the Department of
Labor. In 1980 the Department of Health Education and Welfare became
the Department of Health and Human Services (HHS).
---------------------------------------------------------------------------
Since 1970, coal mine operators and MSHA have used approved coal
mine dust personal sampler units (CMDPSUs) to determine the
concentration of respirable dust in coal mine atmospheres. These
devices sample the mine atmosphere by drawing mine air through a filter
cassette that collects respirable coal mine dust. At the end of a full
shift or 8 hours, whichever time is less, the cassette is sent to MSHA
for processing. Each cassette is weighed under controlled conditions to
determine the average concentration of respirable coal mine dust to
which the affected miners were exposed.
In the 1990s, NIOSH began research and development to produce a
prototype technology for a new type of personal dust monitor that could
provide readings of dust levels in the mine immediately during the
shift and at the end of the shift. This would eliminate the delay in
obtaining an offsite laboratory analysis which requires days before the
results are made available to the mine operator and MSHA. The promise
of the new technology, which is referred to generically as a
``continuous personal dust monitor'' (CPDM), was that it could allow
mine operators to promptly identify and respond to dust exposures
exceeding the applicable MSHA standards. With this new technology,
operators could evaluate causes of overexposures, implement control
measures to reduce exposures, and adjust such controls as necessary.
In 2003, Rupprecht and Patashnick Co., Inc., now Thermo Fisher
Scientific, developed an initial prototype CPDM under contract with
NIOSH. The prototype incorporated a unique mechanical mass sensor
system called Tapered Element Oscillating Microbalance (TEOM[supreg]).
The TEOM mass sensor is made up of a hollow tapered tube, which is
clamped at its base and free to oscillate at its narrow or free end on
which the collection filter is mounted. Electronics positioned around
the sensor cause the tube to oscillate (or resonate) at its natural
frequency. When dust particles are deposited on the collection filter,
the mass of the collection filter increases, causing the natural
oscillating frequency of the tapered element to decrease. Because of
the direct relationship between mass and frequency change, the amount
of respirable dust deposited on the filter can be determined by
measuring the frequency change. The
[[Page 17513]]
concentration of respirable dust in the mine atmosphere is then
determined by a computer incorporated in the CPDM, which divides the
mass of dust collected by the volume of mine air that passed through
the CPDM during the sampled period. The result is reported on the
CPDM's digital display. The cumulative average dust concentration is
calculated and reported continuously over the duration of the shift and
at the end of the shift. The data are also retained for downloading
onto any personal computer with a Microsoft Windows[supreg] operating
system using accompanying software. The prototype also projected the
end-of-shift average dust concentration continuously during the shift.
This information can be used to give early warnings of deteriorating
dust controls to mine operators, allowing corrective action to be taken
before the dust control system fails resulting in full-shift exposures
exceeding regulatory limits.\2\
---------------------------------------------------------------------------
\2\ For a more complete description of the technology, see:
Volkwein, J.C., Vinson, R.P., S.J. Page, L.J. McWilliams, G.J. Joy,
S.E. Mischler, and D.P. Tuchman. Laboratory and field performance of
a continuously measuring personal respirable dust monitor. CDC RI
9669. September 2006. 47 pp. and Volkwein, J.C., R.P. Vinson, L.J.
McWilliams, D.P. Tuchman, and S.E. Mischler, Performance of a New
Personal Respirable Dust Monitor for Mine Use. CDC RI 9663. June
2004.
---------------------------------------------------------------------------
In 2006, NIOSH, in collaboration with MSHA, the mining industry,
and labor, completed extensive testing to evaluate the accuracy of the
pre-commercial CPDM and its suitability for use in underground coal
mines in terms of ergonomics and durability. The testing verified that
the device achieved with 95 percent confidence end-of-shift
measurements within 25 percent of reference measurements
\3\ taken in a variety of coal mines. In addition, the testing
demonstrated that the device was acceptable to miners from an
ergonomics standpoint, and was sufficiently durable to withstand the
conditions of transportation and use in the mines.\4\
---------------------------------------------------------------------------
\3\ Reference measurements were established using multiple
gravimetric samplers in dust exposure chambers for laboratory
testing and using CMDPSUs in a variety of coal mines for field
testing.
\4\ See: Volkwein, J.C., R.P. Vinson, S.J. Page, L.J.
McWilliams, G.J. Joy, S.E. Mischler, and D.P. Tuchman. Laboratory
and field performance of a continuously measuring personal
respirable dust monitor. CDC RI 9669. September 2006. 47 pp. and
Volkwein, J.C., R.P. Vinson, L.J. McWilliams, D.P. Tuchman, and S.E.
Mischler. Performance of a New Personal Respirable Dust Monitor for
Mine Use. CDC RI 9663. June 2004.
---------------------------------------------------------------------------
B. Rulemaking History
Existing 30 CFR part 74, ``Coal Mine Dust Personal Sampler Units,''
includes procedures and requirements which MSHA and NIOSH use to
jointly approve the design, construction, performance, and
manufacturing quality of the CMDPSU. Part 74 is design-specific and
does not permit the approval of coal mine dust sampling devices of a
different design than currently approved. The CMDPSU is currently the
only sampling device approved for use in coal mines to monitor miners'
exposure to respirable coal mine dust. The new CPDM technology cannot
be approved under the existing regulation.
MSHA and NIOSH recognize that the CPDM's ability to measure in real
time the concentrations of respirable coal mine dust to which a miner
is exposed could improve health protection of miners because the CPDM
allows mine operators to take prompt action to prevent dust
overexposures. Accordingly, the CPDM technology can be a vital element
in the strategy used by mine operators and MSHA to more effectively
control miners' exposure to respirable coal mine dust.
To accommodate approval of the new CPDM technology, MSHA and NIOSH
published a proposed rule to revise part 74 (on January 16, 2009 (74 FR
2915)). The agency received comments on the proposed rule and held one
public hearing on July 8, 2009, (74 FR 27265) in Arlington, Virginia.
The comment period closed on August 14, 2009.
Although this final rule addresses approval of the CPDM, existing
standards under 30 CFR parts 70, 71 and 90 will need to be revised
before any new dust exposure monitoring technology can be used in coal
mines for compliance purposes. This final rule does not address
compliance-related issues, such as how the CPDM will be used, who would
be required to wear such a device and when.
The final rule also updates existing design requirements for
approving CMDPSUs to reflect improvements incorporated voluntarily by
the manufacturer since the mid 1990s in the currently approved sampling
device.
II. Summary of Final Rule
This final rule revises existing requirements for the approval of
personal dust monitoring devices in 30 CFR part 74. It also establishes
performance-based and other requirements for approval of the new CPDM.
Part 74 is renumbered as follows:
Subpart A--General.
Subpart B--Approval Requirements for Coal Mine Dust Personal
Sampler Unit--specifications for existing technology.
Subpart C--Approval Requirements for Continuous Personal Dust
Monitors--specifications for new technology.
Subpart D--General Requirements for All Devices--administrative
provisions applicable to both the CMDPSU and CPDM.
III. Section-By-Section Analysis
Subpart A--General
A. Sec. 74.1 Purpose
Final Sec. 74.1, establishes requirements for approval of coal
mine dust sampling devices designed to determine the concentrations of
respirable dust in coal mine atmospheres; procedures for applying for
such approval; test procedures; and labeling. Final 74.1 is unchanged
from the proposal and addresses both CMDPSU and CPDM technology. MSHA
received no comments on the proposal.
B. Sec. 74.2 Definitions
Final Sec. 74.2, like the proposal, is a new section that defines
key terms used in the final rule.
Final paragraphs (a) and (b), like the proposal, define the
concepts of ``accuracy'' and ``bias'' as they apply to CPDMs. They are
key performance parameters for testing and approving the CPDM. MSHA
received no comments on the proposal.
Final paragraphs (c) and (d), like the proposal, define the two
types of coal mine dust sampling devices covered by this final rule,
the ``CMDPSU'' and the ``CPDM''. The definitions are included to
distinguish between the two types of dust monitoring technology. MSHA
received no comments on the proposal.
Final paragraph (e), like the proposal, defines the ``International
Organization for Standardization (ISO)'' as a voluntary consensus
standards-setting organization. An ISO standard is relied on in this
final rule (see Sec. 74.9). MSHA received no comments on the proposal.
Final paragraph (f), like the proposal, defines the concept of
``precision'' as it applies to the CPDM. Precision is the third key
performance parameter for the testing and approval of CPDMs. MSHA
received no comments on the proposal.
Subpart B contains the approval requirements that apply to the
CMDPSU.
C. Sec. 74.3 Sampler Unit
Final Sec. 74.3, like the proposal, renumbers existing Sec. 74.2,
and specifies the major components of a CMDPSU and remains unchanged
from the proposal. MSHA received no comments on the proposal.
[[Page 17514]]
D. Sec. 74.4 Specifications of Sampler Unit
Final Sec. 74.4, like the proposal, renumbers existing Sec. 74.3
and updates the requirements of the existing provision to reflect
currently approved sampling technology.
Final paragraph (a)(1) updates existing pump dimensions to reflect
the smaller and more compact size of currently approved sampling
device: 4 inches (10 centimeters) in height; 4 inches (10 centimeters)
in width; and 2 inches (5 centimeters) in thickness.
A commenter suggested that volume instead of size would be a
preferable design parameter as it would not restrict future pump
innovation and improvement and recommended a nominal value of 500-
525cm\3\. MSHA believes that this suggestion is inconsistent with the
design-specific regulatory requirements applicable to the CMDPSU. MSHA
experience indicates that specifying size as a design parameter has not
restricted pump innovation and improvement as evidenced by the reduced
size of the currently-approved pump unit, resulting from product
improvements undertaken voluntarily by the manufacturer. The final rule
remains unchanged from the proposal.
Final paragraph (a)(2), like the proposal, updates the existing
maximum pump weight to 20 ounces (567 grams) to reflect the reduction
in the weight of the currently approved pump unit. MSHA received no
comment on the proposal.
Final paragraph (a)(3), like the proposal, updates existing
requirements for the construction of the pump case and pump components
by requiring protection against radio frequency and electromagnetic
interference. This improvement will prevent potential instrument error
or malfunction due to exposure to electromagnetic fields and various
radio frequency ranges and signal strengths encountered in coal mines
from power stations, electric motors and remote control transmitters.
The final rule includes the proposed requirement that the case and
components of the pump unit must be of durable construction and tight-
fitting. MSHA received no comments on the proposal.
Final paragraphs (a)(4) and (a)(5), are the same as the proposal.
These provisions require that: (1) The pump exhaust into the pump case
to maintain a slight positive pressure; and (2) the pump unit be
equipped with an ON/OFF switch that is protected against accidental
operation during use and protected to keep dust from entering the
mechanisms. MSHA received no comments on the proposal.
Final paragraph (a)(6), like the proposal, requires the pump unit
to be equipped with a means to make flow rate adjustments accessible
from outside the case. The flow rate adjuster must be recessed in the
pump case and protected against accidental adjustment. If the pump is
capable of maintaining flow rate consistency without adjustment, an
external flow rate adjuster is not required. MSHA received no comments
on the proposal.
Final paragraph (a)(7), like the proposal, requires that the power
supply for the pump be a suitable battery located in the pump case or
in a separate case which attaches to the pump by a permissible
electrical connection. MSHA received no comments on the proposal.
Final paragraph (a)(8), like the proposal, requires that the
irregularity in flow rate due to pulsation have a fundamental frequency
of not less than 20 Hz. It also requires that the quantity of
respirable dust collected with a sampling device be within
5 percent of that collected with a sampling head assembly operated with
nonpulsating flow. MSHA received no comments on the proposal.
Final paragraphs (a)(9) and (a)(10), like the proposal, retains the
existing provisions requiring the pump unit to be equipped with a belt
clip and a suitable connection to allow the battery to be recharged
without removing it from the pump case or battery case. MSHA received
no comments on the proposal.
Final paragraphs (a)(11), like the proposal, requires a visual
indication of the flow rate and specifies the calibration of the flow
rate indicator. It updates existing calibration requirements to be
within 5 percent at 2.2, 2.0, and 1.7 liters per minute.
The higher flow rates for calibration purposes better reflect the
operating flow rate range specified in final paragraph (a)(12). MSHA
received no comments on the proposal.
Final paragraph (a)(12), like the proposal, retains the existing
requirement that the pump operate within a range from 1.5 to 2.5 liters
per minute and be adjustable over this range. MSHA received no comments
on the proposal.
Final paragraph (a)(13), like the proposal, requires the flow rate
to remain consistent or stable over at least a 10-hour period, when the
pump is operated at 2 liters per minute. This flow-rate consistency
reflects the operating range of the currently approved sampling device
and the prevalence of work shifts exceeding 8 hours in duration. The
final rule, like the proposal, does not include the existing
requirement to readjust the flow rate during the shift since the
currently approved sampling device is designed to maintain a constant
flow rate without requiring any readjustments during sampling. MSHA
received no comments on the proposal.
Final paragraph (a)(14), like the proposal, is a new provision that
requires the pump unit to be equipped with a flow restriction
indicator. This new requirement reflects technology incorporated in the
currently approved sampling device to prevent the shutdown of the pump
during sampling and subsequent loss of the sample if the flow
restriction is not corrected. The flow restriction indicator enables
more accurate sampling of the mine atmosphere in the active workings.
MSHA received no comments on the proposal.
Final paragraph (a)(15), like the proposal, specifies the required
maximum expected operating time that the pump with a fully charged
battery pack must be capable of operating at specific flow rates and
sampling device loading. This paragraph reflects the higher level of
operating performance inherent in the currently approved sampling
device to permit sampling of shifts longer than 8 hours commonly worked
today. Under the final rule, the existing resistance requirement for 8
hours of operation at a flow rate of 2 liters per minute is increased
from 4 inches (10 centimeters) to 25 inches (64 centimeters) of water,
as measured at the inlet of the pump. The final rule, like the
proposal, adds a new provision that reflects technology incorporated in
the currently approved sampling device. It requires the pump unit to
operate not less than 10 hours at a flow rate of 2.5 liters per minute
against a resistance of 15 inches (38 centimeters) of water. MSHA
received no comments on the proposal.
Final paragraph (a)(16), like the proposal, is a new provision that
requires the pump unit to be equipped with a low battery indicator.
This provision reflects technology incorporated in the currently
approved sampling device and is considered an important design feature.
Failure of the battery during sampling results in loss of the sample
and the inability to determine the concentrations of respirable coal
mine dust in the work environment being monitored. MSHA received no
comments on the proposal.
Final paragraph (a)(17), like the proposal, is a new provision and
requires the pump unit to be equipped
[[Page 17515]]
with an elapsed time indicator displaying the actual pump run time
after the pump is shut down due to a flow restriction or low battery
power, or at the end of the sampling shift. This provision reflects
technology incorporated in the currently approved sampling device and
is necessary to determine if sampling was conducted for the required
duration. Knowing the actual sampling time is essential for determining
the concentration of respirable coal mine dust in the work environment
being monitored. MSHA did not receive any comments on the proposal.
Final paragraph (b), like the proposal, addresses requirements for
the sampling head assembly of the CMDPSU, which consist of a cyclone
and a filter assembly.
Final paragraphs (b)(1) and (b)(2)(i), like the proposal, specify
the components and construction of the cyclone, including dimensions of
the components, and the characteristics of the collection filter. MSHA
did not receive any comments on the proposal.
Final paragraph (b)(2)(ii), like the proposal, specifies
characteristics and construction of the capsule enclosing the filter,
and requires that the capsule prevent visual inspection of the filter
surface or filter loading. It reflects the design and construction of
the currently approved filter assembly, called the dust cassette, to
safeguard the accuracy, integrity, and validity of the collected
sample. MSHA did not receive any comments on the proposal.
Final paragraph (b)(2)(iii), like the proposal, specifies
requirements for the cassette enclosing the capsule. It requires the
cassette to completely enclose the filter capsule so as to prevent
contamination and intentional or inadvertent alteration of dust
deposited on the filter. The final rule also requires the cassette be
designed to prevent reversal of the air flow through the capsule or
other means of removing dust collected on the filter. These
requirements reflect design of the currently approved filter assembly
or dust cassette technology and are intended to safeguard the accuracy,
integrity, and validity of the sample. MSHA did not receive any
comments on the proposal.
Final paragraphs (b)(3) and (b)(4) are the same as the proposal.
Final paragraph (b)(3) addresses the connections between the cyclone
vortex finder and the filter capsule and connections between the filter
capsule and hose. Final paragraph (b)(4), like the proposal, addresses
clamping and positioning requirements of components. It requires that
the cyclone-cassette assembly be firmly in contact, airtight and be
attached firmly to a backing plate or other means of holding the
sampling head in position. MSHA did not receive any comments on the
proposal.
Final paragraph (b)(5), like the proposal, includes requirements
for the hose connecting the sampler pump and the filter assembly. It
requires that the hose be clear plastic. This provision reflects
currently-approved technology and allows for examination of the
external tubing to assure that it is clean and free of leaks, as
accumulations or leaks could affect the accuracy of sampling results.
MSHA did not receive any comments on the proposal.
Final paragraph (c) addresses requirements for the battery charger
of the CMDPSU.
Final paragraph (c)(1), like the proposal, specifies the voltage
and frequency requirements for the battery charger. It reflects
currently used power supply voltage of 110 (VAC)(nominal). MSHA did not
receive any comments on the proposal.
Final paragraphs (c)(2) and (c)(3), like the proposal, require that
the battery charger be provided with a cord and polarized connector and
that it be fused and have a grounded power plug. MSHA did not receive
any comments on the proposal.
Final paragraph (c)(4), like the proposal, reflects currently
approved technology and requires that the battery charger be capable of
fully recharging the battery in the pump unit within 16 hours. MSHA did
not receive any comments on the proposal.
E. Sec. 74.5 Tests of Coal Mine Dust Personal Sampler Units
Final Sec. 74.5, like the proposal, renumbers existing Sec. 74.4
and provides authority for NIOSH and MSHA testing to evaluate whether
the CMDPSU meets the requirements of the final rule. MSHA did not
receive any comments on the proposal.
F. Sec. 74.6 Quality Control
Final Sec. 74.6, like the proposal, includes a clarifying
reference to final Sec. 74.13 (filing applications). MSHA did not
receive any comments on the proposal.
Subpart C--Requirements for Continuous Personal Dust Monitors (CPDMs)
G. Sec. 74.7 Design and Construction Requirements
Final Sec. 74.7 provides design and construction requirements for
the CPDM. The requirements are performance-oriented to allow
manufacturers flexibility for continued innovation in this new
technology. Where necessary and appropriate, the final rule includes
design requirements to assure miner safety or accommodate specific
mining conditions.
Final paragraph (a), like the proposal, requires that the CPDM be
designed and constructed to allow miners to work safely. It also
requires that the device be suitable to work requirements and working
conditions of coal mining. MSHA did not receive any comments on the
proposal.
Final paragraph (b), like the proposal, addresses ergonomic design
requirements. It requires that, prior to filing an application under
final Sec. 74.13, the applicant must develop a testing protocol to
determine if coal miners can wear the CPDM safely and without
discomfort or impairment in the performance of their work duties
throughout a full work shift. The protocol includes provisions for
testing in one or more active mines under routine operating conditions.
The testing protocol must be submitted to NIOSH prior to testing. In
addition, the testing protocol and testing results must be submitted to
NIOSH as part of the application for approval. NIOSH will advise and
assist the applicant in developing an adequate testing protocol and
arranging for adequate and competent testing resources, including, but
not limited to, identifying testing experts and facilitating the
cooperation of coal operators and miners. NIOSH reserves the authority
to waive the requirement for the applicant to conduct such testing when
it is apparent ``that the device can be worn safely, without
discomfort, and without impairing a coal miner in the performance of
duties throughout a full work shift.'' MSHA did not receive any
comments on the proposal.
Final paragraph (c), like the proposal, requires that the weight of
a CPDM add no more than 2 kg to the total weight carried by the miner.
However, a CPDM combined with other functions, such as communications
or illumination, could weigh more than 2 kg if offset by the weight of
a device the miner would no longer have to carry. In this case, the
total added weight must not exceed the weight normally carried by
miners without CPDMs by more than 2 kg. The 2-kg limit is based on the
professional judgment of MSHA and NIOSH staff that the added load to
miners needs to be minimized, considering that the safety gear and
equipment currently worn and carried by underground coal miners can
weigh up to approximately 16 kg. The limit in the final rule reflects
[[Page 17516]]
the weight of the prototype CPDM, which in NIOSH testing was worn and
used by miners for full shifts and proved to be tolerable. The
prototype device weighed approximately 3 kg, but served to power the
cap lamp as well, so that a separate battery was not needed for the
miner's cap lamp. In combination, the prototype with its dual-use
battery increased the personal equipment load of the miners by less
than 2 kg. MSHA did not receive any specific comments on this
provision.
Final paragraph (d) requires that the CPDM provide accurate end-of-
shift measurements of average respirable coal mine dust concentrations
within the range of 0.2 to 4.0 mg/m\3\. For end-of-shift average
concentrations exceeding 4.0 mg/m\3\, the CPDM must provide a reliable
indication that the concentration exceeded 4.0 mg/m\3\. This represents
a change from the proposal in response to comments, which indicated
some confusion and misinterpretation of the proposal. The proposal
would have required that the CPDM provide accurate end-of-shift
measurements of average respirable dust concentrations within the range
of 10% to 2 times the permissible exposure limit (PEL) for respirable
coal mine dust (currently 2.0 mg/m\3\ when quartz content does not
exceed 5%), and provide a reliable indication when the concentration
exceeds 2 times the PEL. A commenter asked if the proposed requirement
would remain the same if a dust sample contains more than 5% quartz
causing the PEL to be subsequently reduced. This commenter also asked
if the proposed requirement would remain the same if MSHA ever reduces
the PEL for respirable dust or for quartz dust through future
rulemaking. MSHA believes that the proposal could have been more
clearly stated.
To provide better clarity regarding the actual range of average
respirable coal mine dust concentrations over which the CPDM must
provide accurate end-of-shift measurements, the final rule establishes
the measurement range by defining a lower and upper range of average
dust concentrations over which the CPDM must perform accurately. The
final rule does not change the original intent of the proposal, which
was to establish performance criteria for approving CPDM devices that
accurately measure end-of-shift average dust concentrations based on
current direct-reading monitoring technology.
The measurement range in the final rule reflects the actual range
of average dust concentrations over which current CPDM technology
performed accurately. The final requirement assures that the CPDM will
provide accurate measurements of actual dust concentrations as low as
0.2 mg/m\3\ (10% of the existing PEL) to permit monitoring of dust
concentrations in active workings of coal mines under existing reduced
standards due to quartz with no further accuracy testing. MSHA did not
intend to address any issues related to a lower PEL for respirable coal
mine dust or quartz in this rulemaking. In the event the PEL is reduced
through rulemaking in the future resulting in reduced dust standards
below 0.2 mg/m\3\, the accuracy of the CPDM in monitoring the lower
concentration limits would need to be verified with additional testing.
Final paragraph (e), like the proposal, requires that the CPDM
operate reliably and accurately within the full range of environmental
conditions encountered in coal mines. It requires that the CPDM operate
reliably and accurately at any ambient temperature and varying
temperatures ranging from minus 30 to plus 40 degrees Centigrade; at
any atmospheric pressure from 700 to 1000 millibars; at any ambient
humidity from 10 to 100 percent relative humidity; and while exposed to
water mists generated for dust suppression and while monitoring
atmospheres including such water mists. These parameters, in addition
to those in paragraphs (f) and (g) of this section, address the full
range of environmental conditions found in coal mines. MSHA and NIOSH
specifically solicited comments on these parameters, as well as any
others that might be appropriate. MSHA did not receive any comments on
the proposal.
Final paragraph (f), like the proposal, requires that the CPDM meet
standards established by the American National Standards Institute
(ANSI), the Federal Communications Commission (FCC), and the
International Electrotechnical Commission (IEC) for control of and
protection from electromagnetic interference. The FCC is an independent
Federal agency that regulates radiofrequency emitting devices. ANSI and
IEC are voluntary standards-setting organizations, the former covering
a variety of technical and management areas and the latter specializing
in electrotechnology. The use of these standards would address the
potential for interference associated with the increasing use of
radiofrequency controls for mining machinery and mine communication
systems.
Final paragraph (f)(1) requires the CPDM to meet emissions
requirements of IEEE Std. C95.1-2005, IEEE Standard for Safety Levels
with Respect to Human Exposure to Radio Frequency Electromagnetic
Fields, 3 kHz to 300 GHz. The proposal would have required that the
operator meet the requirements of ANSI C95.1-1982 (Standard for Safety
Levels with Respect to Human Exposure to Radio Frequency
Electromagnetic Fields). The ANSI C95.1-1982 reference in the proposal
has been updated and the final rule is changed to include the latest
reference. MSHA did not receive any comments on the proposal.
Final paragraph (f)(2), like the proposal, requires that the CPDM
meet the immunity and susceptibility requirements of the International
Electrotechnical Commission (IEC) 61000-4-6.
A commenter stated that the proposal was confusing as to the depth
of testing required. This commenter asked if the intent of the proposal
was to test against the entire section of 610000-4 through 61000-6, or
only sections 61000-4 and 61000-6, or the specific test defined in
61000-4-6.
MSHA inadvertently cited the IEC reference in the proposal as IEC
61000-4 and 61000-6. The proposal should have been phrased as follows:
``persons must proceed in accordance with IEC 61000-4-6
(Electromagnetic compatibility--Part 4-6: Testing and measurement
techniques--Immunity to conducted disturbances, induced by radio-
frequency fields).'' In response to the commenter's question, the
Agency clarified in the hearing notice (74 FR 27263) its intent that
the proposed test be in accordance with the specific test defined in
IEC 61000-4-6. The final rule includes this nonsubstantive correction.
Final paragraph (g), like the proposal, requires that the CPDM be
designed and constructed to remain safe and accurate after undergoing
durability evaluation involving vibration and drop tests representative
of conditions of use in the mine. In testing for vibration, NIOSH will
use Military Standard 810F, 514.5. This test measures the degree of
vibration expected while the device is worn by miners on and operating
mining equipment and during transport in and out of the mine. The drop
test that NIOSH applies will involve three 3-foot drops onto a bare
concrete surface (one drop testing each axis of the device). This test
represents the occasional drops and knocking of the device expected
during use of the device by miners. NIOSH will conduct the testing
regime on test devices prior to further testing by the applicant under
Sec. 74.8 and intrinsic safety testing by MSHA under Sec. 74.11(d).
MSHA did not receive any comments on this proposal.
Final paragraphs (h)(1) and (2) require adequate legibility or
audibility of monitoring results, computer (i.e.,
[[Page 17517]]
digital) recording of results in a form compatible with widely
available computer technology, and reporting of results as cumulative
mass concentration in units of mass per volume of air (mg/m\3\). The
visibility requirement for a minimum digital character height of 6
millimeters is based on testing during CPDM prototype development. All
other requirements in this provision allow flexibility for new
innovative designs that would provide timely, reliable, and
appropriately quantified information.
A commenter stated that, except for provisions for the size of
characters and end of shift results, there is nothing in the rule that
provides for results for shorter time periods (from minutes to hours).
This commenter stated that an instrument that provides only the end of
shift results would not be acceptable. Additionally, whatever number
the instrument displays should not be truncated and, instead, should be
rounded as is the customary practice in most other applications. This
commenter suggested that the information displayed on the CPDM be the
same as described in NIOSH Publication RI 9669, ``Laboratory and Field
Performance of a Continuously Measuring Personal Respirable Dust
Monitor.''
Since monitoring of compliance with the applicable dust standard
will continue to be based on the average dust concentration measured
over a full shift, it is vital that the CPDM provide accurate full-
shift (or end-of-shift) measurements. It should be noted that shorter
time period data may also be available. However, MSHA believes that to
prescribe the time period for intra-shift measurements of less than 8
hours may limit future CPDM development. The final rule does not
include the commenter's suggestion.
In response to the commenter's suggestion that the concentration
values displayed by the instrument should be rounded instead of
truncated, paragraph (h)(2) in the final rule has been modified to
require the CPDM to report cumulative mass concentrations with two
significant figures of accuracy rounded as the customary practice. The
commenter's suggestion that the information displayed on the CPDM be
the same as described in NIOSH Publication RI 9669, ``Laboratory and
Field Performance of a Continuously Measuring Personal Respirable Dust
Monitor'' was not adopted to permit continued innovation in how dust
concentration measurements are displayed by CPDMs.
Final paragraph (i), like the proposal, requires that the power
source for the CPDM have sufficient capacity to enable continuous
sampling for 12 hours in a coal mine dust atmosphere up to 4.0 mg/m\3\.
This requirement provides reasonable assurance that the power supply is
sufficient to enable accurate measurement of respirable dust
concentrations for 12-hour work shifts, which according to MSHA data,
would accommodate some of the longer recorded shifts currently being
worked in underground coal mines. MSHA's data indicate that 98 percent
of work shifts in active underground mines are 10 hours or less and
over 99 percent of work shifts are 12 hours or less.
It should be recognized that if dust concentrations in the active
workings being monitored exceed 4.0 mg/m\3\ continuously over a 12-hour
period, a power supply meeting this requirement might not be sufficient
to sustain monitoring for the complete shift. This is because sampling
environments containing higher dust concentrations will result in
increased particulate loading on the sample collection media which
places greater power demands on the CPDM to increase pump speed and
maintain the required sample flow rate without requiring any mid-course
adjustments. However, since over 99 percent of the underground coal
mines work shifts that are 12 hours or less, the final rule provides
sufficient assurance that the CPDM will have the power capacity to
monitor high dust concentrations during the entire work shift, and to
cumulatively document that miner's exposure exceeded the PEL for the
full shift. Final paragraph (i), like the proposal, also requires that
a CPDM that uses a rechargeable battery be recharged using the standard
power supplies in mines (110 VAC).
Several commenters supported the proposed requirement that the CPDM
be powered continuously for 12 hours since miners work shifts longer
than 8 hours. However, they also suggested that CPDMs be capable of
operating for a minimum of 16 hours to accommodate full work shifts, up
to 16 hours. One of the commenters further suggested that, if this is
not feasible, it should be required in two years. While MSHA recognizes
that some miners may work longer than 12 hours, those situations are
neither typical nor wide spread. Since the performance requirements in
the final rule are intended to address typical mining operating
conditions, they do not include the commenters' suggestion that the
CPDM be capable of operating up to 16 hours. Further, given the current
state of battery technology, a 16-hour battery would significantly
increase the size and weight of the CPDM beyond the limits specified in
this final rule.
Final paragraph (j), like the proposal, requires that if a CPDM
uses a pump to sample the atmosphere, it must perform with a flow
stability within five percent of the calibrated flow for
95% of samples for a continuous duration of 12 hours.\5\ This
requirement is integral to achieving representative, accurate
measurements of respirable coal mine dust concentrations. The paragraph
also requires that the applicant specify the flow calibration
maintenance interval necessary to achieve the required level of flow
stability in the calibration instructions for the device. MSHA did not
receive any comments on the proposal.
---------------------------------------------------------------------------
\5\ NIOSH Manual of Analytic Methods, Method 0600, Issue 3,
Fourth Edition, January 15, 1998.
---------------------------------------------------------------------------
Final paragraph (k), like the proposal, requires that a CPDM using
a rechargeable battery have a battery check feature to indicate to the
user that the device is adequately recharged to operate as intended for
an entire work shift of up to 12 hours under normal conditions of use.
This important feature will minimize using CPDMs whose battery was not
fully charged to permit full-shift monitoring without experiencing a
monitoring failure during the shift due to low battery power. MSHA did
not receive any comments on the proposal.
Final paragraph (l), like the proposal, sets forth requirements for
CPDMs that share components with other personal equipment carried by an
underground miner, such as cap lamps.
Final paragraph (l)(1), like the proposal, requires the applicant
to obtain necessary approvals required for other devices if the CPDM is
integrated or shares functions with such devices used in mines, such as
cap lights or power sources, prior to receiving final approval of the
CPDM from NIOSH. This provision enables NIOSH to assure all
requirements, as appropriate, are met for other devices integrated with
or sharing functions with the CPDM that are not approved by NIOSH.
Final paragraph (l)(2), like the proposal, requires that the CPDM
operate effectively with the integrated functions. This provision
assures that the CPDM is not compromised by integration of functions
and provides reasonable assurance that the device functions as
intended. MSHA did not receive any comments on the proposal.
Final paragraph (m), like the proposal, specifies performance
requirements that help assure that CPDMs are designed to prevent
intentional tampering or inadvertent altering of monitoring
[[Page 17518]]
results. It requires that the CPDM have a safeguard or indicator which
either prevents altering the measuring or reporting functions of the
device or indicates if these functions have been altered.
This requirement will assure that manufacturers design and
incorporate tampering safeguards and indicators in the CPDM that
address foreseeable actions by users. It also allows NIOSH to require,
to the extent feasible, changes in the design of an already approved
device, following discovery of tampering methods or inadvertent actions
that can alter monitoring results.
A commenter supported the proposed requirement; however, the
commenter doubted that safeguards could prevent tampering altogether.
This commenter suggested that MSHA have other methods to prevent and
detect tampering and to prosecute those who perpetuate this action.
MSHA recognizes the importance of having a credible monitoring program
that provides meaningful health surveillance and confidence in the
program. MSHA's actions to improve sampling technology, to investigate
questionable sampling practices, and take appropriate legal action
demonstrate the Agency's commitment to maintain a credible and reliable
dust monitoring program. While it may be difficult to prevent tampering
all together, MSHA has not ignored this important issue and believes
that the CPDM technology should limit the ability to alter monitoring
results. MSHA believes that the final rule addresses commenters'
concerns with respect to tampering or altering CPDM results. MSHA will
continue to evaluate operator results, conduct its own sampling,
follow-up on reports of inappropriate sampling practices, conduct
investigations as it has in the past, and take appropriate enforcement
action.
Final paragraph (n), like the proposal, requires that the CPDM be
designed to assure that it can be properly cleaned and maintained to
perform accurately and reliably for the duration of its service life.
The infiltration and accumulation of dust and moisture in components
can adversely affect the operability and monitoring accuracy of a CPDM.
MSHA did not receive any comments on the proposal.
H. Sec. 74.8 Measurement, Accuracy, and Reliability Requirements
Final Sec. 74.8, like the proposal, establishes new performance
requirements for CPDMs. These requirements reflect current evaluation
methods for assessment of direct-reading monitors. These methods have
been summarized and issued as general guidelines by NIOSH in
``Components for the Evaluation of Direct-Reading Monitors for Gases
and Vapors''.\6\ The requirements also reflect the state-of-the-art
technology of the CPDM prototype. Accordingly, this final rule
establishes a science-based, feasible baseline for the performance of
the new CPDM technology. Upon request, NIOSH will provide a report on
the performance of the prototype CPDMs. The results are partially
summarized in several peer-reviewed journal articles.\7\
---------------------------------------------------------------------------
\6\ Kennedy, E. R., T.J. Fischbach, R. Song, P.M. Eller, and
S.A. Shulman, 1995. Guidelines for air sampling and analytical
method development and evaluation, DHHS (NIOSH) Publication No. 95-
117.
\7\ Volkwein, J.C., R.P. Vinson, S.J. Page, L.J. McWilliams,
G.J. Joy. S.E. Mischler and D.P. Tuchman. Laboratory and field
performance of a continuously measuring personal respirable dust
monitor. CDC RI 9669. September 2006. 47 pp. and Volkwein, J. C.,
R.P. Vinson, L.J. McWilliams, D.P. Tuchman, and S.E. Mischler.
Performance of a New Personal Respirable Dust Monitor for Mine Use.
CDC RI 9663. June 2004.
---------------------------------------------------------------------------
Final paragraph (a), like the proposal, requires that the CPDM be
capable of measuring respirable dust within the personal breathing zone
of the miner whose exposure is being monitored. The breathing zone is
generally considered to be the area surrounding the worker's nose and
mouth. This zone is pictured by drawing a sphere with a 10-inch radius
which is centered on the nose. Current industrial hygiene principles
accept breathing zone samples as most representative of the atmosphere
to which workers are exposed.\8\ MSHA did not receive any comments on
the proposal.
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\8\ Guffy, S.E., M.E. Flanagan, G. VanBelle. Air Sampling at the
chest and ear as representative of the breathing zone. AIHAJ,
62:416-427, 2001, show that ear locations are preferred and that
dust sources relative to sample position are important. A NIOSH
study on miners shows that the chest and cap lamp positions are
representative of exposures at the miner's nose (Vinson, R.P. and J.
C. Volkwein, Determining the Spatial Variability of Personal Sampler
Inlet Locations (in press) JOEH, 2007).
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Final paragraph (b), like the proposal, provides requirements for
the measurement accuracy of the CPDM. MSHA did not receive any comments
on the proposal.
Final paragraph (b)(1), like the proposal, requires for full-shift
measurements of 8 hours or more, a 95 percent confidence that the
recorded measurements are within 25 percent of the true
dust concentration, as determined by CMDPSU reference measurements,
over a concentration range from 0.2 to 4.0 mg/m\3\. The specific degree
of accuracy required is based on the current state of the technology of
direct-reading monitors and on the need for reasonable accuracy in
industrial hygiene assessments to assure worker protection. NIOSH has
demonstrated the feasibility of this accuracy requirement through
testing of the CPDM prototype.\9\
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\9\ Volkwein, J.C., R.P. Vinson, L.J. McWilliams, D.P. Tuchman,
and S.E. Mischler. Performance of a New Personal Respirable Dust
Monitor for Mine Use. CDC RI 9663. June 2004.
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The concentration range of 0.2 to 4.0 mg/m\3\ over which the CPDM
must provide accurate measurements is also based on current CPDM
technology, as represented by the pre-commercial device. This
technology requires a minimum quantity of dust loading on the
microbalance filter before the CPDM can provide an accurate
measurement. This allows the CPDM to distinguish actual exposure
quantities from small measurement variations due to imperfections of
the CPDM equipment. The lower range of dust concentration levels tested
(0.2 mg/m\3\) assures that accuracy is maintained for situations where
the quartz content in the mine environment exceeds 5 percent causing
the PEL to be reduced. Similarly, there is an upper bound of dust
loading, which is likely to exceed the concentration level of 4.0 mg/
m\3\,\10\ specified in the final rule. Above this concentration level
the current CPDM technology may lose sensitivity as a result of the
heavily loaded filter on the microbalance. The Agencies are confident
that the final rule will assure that the range of end-of-shift average
dust concentrations over which the CPDM must provide accurate
measurements will be adequate to quantify actual full-shift exposures
that may range from exceptionally low to exceptionally high
concentrations. MSHA did not receive any comments on the proposal.
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\10\ NIOSH testing of the CPDM prototype used 4.0 mg/m\3\ dust
concentration as the upper limit in challenging the device for
accuracy. NIOSH did not conduct testing to identify the actual upper
limit at which the accuracy of the prototype would be degraded below
the testing standard, although the ultimate occurrence of such
degradation is predictable based on engineering principles.
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For intra-shift measurements of less than 8 hours, final paragraph
(b)(2), like the proposal, requires a 95 percent confidence that the
recorded measurements are within 25 percent of the true
dust concentration, as determined by CMDPSU reference measurements,
over the dust concentration range equivalent to 0.2 to 4.0 mg/m\3\ for
an 8-hour period. This provision includes a formula for calculating the
equivalent dust concentration range for assessing accuracy of intra-
shift measurements. MSHA did not receive any comments on the proposal.
[[Page 17519]]
Final paragraph (c), like the proposal, requires the CPDM to meet
the accuracy requirements of the final rule regardless of the variation
in density, composition, size distribution of respirable coal mine dust
particles, and presence of spray mist in coal mines. Some monitoring
devices, such as light scattering detectors, use technologies that have
potential for monitoring aerosol dust concentrations. These devices
currently lack the ability to distinguish differences in density and
composition of coal mine dust particles and other aerosols in the mine,
or to accommodate variation in the coal mine dust particle
distribution. To be effective, the CPDM must produce accurate
measurements for any coal mine atmosphere. MSHA did not receive any
comments on the proposal.
Final paragraph (d), like the proposal, requires that the CPDM
monitor with sufficient precision. Under the final rule, precision must
be established through testing to determine the degree to which the
CPDM is able to closely replicate multiple concentration measurements
when sampling identical dust concentrations. The precision requirement
is a relative standard deviation of less than 0.1275 without bias for
multiple measurements. It will enable MSHA and mine operators to
monitor changes in dust concentrations with reasonable confidence. MSHA
did not receive any comments on the proposal.
Final paragraph (e), like the proposal, requires the bias of CPDM
measurements to be limited such that the uncorrectable discrepancy
between the mean of the distribution of measurements and the true dust
concentration being measured during testing be no greater than 10
percent. It also requires that measurement bias be constant over the
range of dust concentration levels tested, between 0.2 to 4.0 mg/m\3\,
for an 8-hour sampling period. This requirement assures that the CPDM
does not consistently either overestimate or underestimate respirable
coal mine dust concentrations to a substantial degree. This provides
further assurance of the accuracy of the CPDM with respect to multiple
measurements. MSHA did not receive any comments on the proposal.
Final paragraph (f), like the proposal, requires applicants to use
the NIOSH testing procedure ``Continuous Personal Dust Monitor Accuracy
Testing,'' June 23, 2008, to evaluate the accuracy, reliability,
precision, and bias of a CPDM. The NIOSH procedure is incorporated by
reference. The procedure is available at the NIOSH Web site: https://www.cdc.gov/niosh/mining/pubs/pubreference/outputid3076.htm. The
procedure requires that testing be performed under diverse
environmental conditions and that test results be submitted, in
writing, to NIOSH. The protocol assures that all CPDMs are evaluated
consistently. NIOSH will provide assistance to applicants, as
necessary, to make the arrangement of such testing feasible. MSHA did
not receive any comments on the proposal.
I. Sec. 74.9 Quality Assurance
Final Sec. 74.9, like the proposal, establishes new quality
assurance requirements for CPDM manufacturers.
Final paragraph (a), like the proposal, requires the applicant to
establish and maintain a quality control system that assures devices
produced under the applicant's certificate of approval meet the
specifications to which they are certified under this part and are
reliable, safe, effective, and otherwise fit for their intended use.
The quality control system must meet the specifications in ISO Q9001-
2000 standard established by the ISO.\11\ The ISO standard is
incorporated by reference. This consensus standard for quality
management is in widespread use in U.S. and international manufacturing
and service industries. It requires a comprehensive quality management
system, which is essential for the manufacture of sophisticated
technical equipment used in worker safety and health.
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\11\ ISO Q9001:2000 is the International Standard: Quality
management systems--Requirements, 3rd edition, approved on December
15, 2000 and available from the International Organization for
Standardization and the American National Standards Institute.
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Final paragraph (a), like the proposal, also requires the applicant
to submit a copy of the most recent registration under ISO Q9001-2000
to NIOSH, together with the application and, subsequent to an approval,
upon request. Registration under ISO Q9001-2000, American National
Standard, Quality Management Systems-Requirements, will be considered
evidence of compliance with the ISO Q9001-2000 standard. NIOSH
considers registration under the ISO quality management standard as
evidence that the applicant has established a sound quality assurance
program. The registration will allow the applicant to use existing and
widely available independent auditing services. MSHA did not receive
any comments on the proposal.
Final paragraph (b), like the proposal, requires applicants or
approval holders to allow NIOSH to conduct quality management audits
when requested or in response to quality-related complaints. NIOSH has
similar authority under its respirator certification program (42 CFR
part 84), which has been used to assure product quality in the
respirator market. This audit authority is essential in the event of
substantial quality management problems in the manufacture of CPDMs.
MSHA did not receive any comments on the proposal.
Final paragraph (c), like the proposal, requires the applicant or
approval holder to correct any quality management deficiencies
identified by NIOSH or an independent audit within a reasonable time as
determined by NIOSH. The final rule also provides that failure to
correct a deficiency may result in the disapproval of a pending
application or revocation of an existing approval until such time as
NIOSH has determined that the deficiency is corrected. NIOSH has
similar authority under its respirator certification program, although
NIOSH has rarely had to employ it. MSHA did not receive any comments on
the proposal.
J. Sec. 74.10 Operating and Maintenance Instructions
Final Sec. 74.10(a), like the proposal, requires the manufacturer
to include operating and storage instructions and maintenance and
service life plan with each new CPDM sold.
A commenter suggested that the proposal provide more specific and
objective criteria so that anybody in the industry can, after reading
them, operate the CPDM. In response to this commenter's suggestion,
final Sec. 74.10(a) has been changed from the proposal to include a
new requirement in paragraph (a)(iv) that the operating instructions
include a one page ``quick start guide'' that will enable a novice to
start and operate the CPDM. Except for renumbering, all other
provisions remain the same.
Final paragraph (b), like the proposal, is new and requires the
manufacturer to submit the instructions and plan under paragraph (a) to
NIOSH with the application for approval. It also requires that
instructions and the plan be submitted if any substantive changes are
made to the approved device or the approved instructions. Adequate
instructions must be provided to facilitate effective use of
sophisticated monitoring equipment. NIOSH review and approval of
instructions serves an important final quality control function for the
manufacturer and assures that instructions are clearly written and
easily understood. NIOSH has similar authority under its respirator
[[Page 17520]]
certification program (42 CFR part 84). MSHA did not receive any
comments on the proposal.
K. Sec. 74.11 Tests of the CPDM
Final Sec. 74.11 establishes new testing requirements for
evaluation of CPDMs.
Final paragraph (a), like the proposal, requires the applicant to
conduct all testing specified in Sec. Sec. 74.7-74.8 of this part,
with the exception of durability testing under Sec. 74.7(g). It
further requires that the testing be performed by an independent
testing entity approved by NIOSH. This requirement provides reasonable
assurance of the quality of testing and the reliability of test
results. MSHA did not receive any comments on the proposal.
Final paragraph (b), like the proposal, provides for NIOSH to
assist the applicant in identifying appropriate testing services. It
also requires that applicants submit testing protocols to NIOSH prior
to testing so that NIOSH can verify their adequacy. It is unlikely that
an applicant would be familiar with testing resources capable of
addressing every element of the final rule. NIOSH will be able to
provide the applicant with information on private and university
laboratories available for testing. In addition, NIOSH review of
testing protocols will minimize the possibility of inadequate testing,
which might result in the applicant incurring unnecessary delay and
costs. MSHA did not receive any comments on the proposal.
Final paragraph (c), like the proposal, requires the applicant to
arrange for the independent testing entity to report testing protocols
and results directly to NIOSH. This direct reporting relationship
between the testing entity and NIOSH further establishes the
independence of the applicant from the testing. MSHA did not receive
any comments on the proposal.
Final paragraph (d), like the proposal, requires the applicant to
submit the CPDM to MSHA for testing and evaluation to determine the
intrinsic safety of a CPDM submitted for approval. MSHA conducts all
intrinsic safety testing for mining equipment used in underground coal
mines. A CPDM that does not pass intrinsic safety testing will not be
approved for use in coal mines. MSHA did not receive any comments on
the proposal.
Subpart D--General Requirements for All Devices
L. Sec. 74.12 Conduct of Tests; Demonstrations
Final Sec. 74.12, like the proposal, addresses procedures for
conducting tests, and renumbers and makes clarifying changes to the
existing provision. This section concerns the management of testing
information prior to and after the issuance of a certificate of
approval.
Final paragraph (a), like the proposal, requires MSHA and NIOSH to
continue the existing practice of not disc
