[Federal Register Volume 75, Number 65 (Tuesday, April 6, 2010)]
[Rules and Regulations]
[Pages 17512-17529]
From the Federal Register Online via the Government Publishing 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
[email protected] (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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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: http://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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 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. Sec. 74.13 Applications
Final Sec. 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.
N. Sec. 74.14 Certificate of Approval
Final Sec. 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. Sec. 74.15 Approval Labels
Final Sec. 74.15, like the proposal, specifies labeling procedures
and other requirements for the applicant. MSHA did not receive any
comments on the proposal.
P. Sec. 74.16 Material Required for Record
Final Sec. 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. Sec. 74.17 Changes After Certification
Final Sec. 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. Sec. 74.18 Withdrawal of Certification
Final Sec. 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
[[Page 17521]]
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
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 battery-powered 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.
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
[[Page 17522]]
of approximately $20,500 ($293,000 x 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 Sec. Sec. 74.7 and 74.8);
$9,500 for MSHA to evaluate and test the CPDM for intrinsic safety
(under proposed Sec. 74.11); $3,200 for the applicant to file an
application for approval of the CPDM (under final Sec. 74.13); and
$30,000 for the cost of the three CPDMs retained by NIOSH and MSHA
(under final Sec. Sec. 74.16(a) and (b)). The final rule costs are
detailed below.
---------------------------------------------------------------------------
\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 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.
---------------------------------------------------------------------------
Final Sec. Sec. 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 Sec. 74.7(b)); environmental conditions (under
final Sec. 74.7(e)); electromagnetic interference (under final Sec.
74.7(f)); flow stability and calibration of pump (under final Sec.
74.7(j)); and accuracy testing which includes reliability measurement,
precision, and bias testing (under final Sec. Sec. 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 Sec. Sec.
74.7 and 74.8. The annualized cost is $17,500 ($250,000 x 0.07).
Final Sec. 74.11 requires that the applicant submit the CPDM to
MSHA for testing and evaluation, under 30 CFR Sec. 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 Sec. 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
Sec. Sec. 18.68(a)(1) and (b)(1). The methane thermal ignition test
will be performed under Sec. Sec. 18.68(a)(1) and (b)(6). The maximum
surface temperature test will be performed under Sec. 18.68(a)(1) and
(b)(3). The spark ignition test will be performed under Sec. Sec.
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
technical support services involved in evaluating an application. Thus,
the cost for MSHA evaluation and testing is approximately $9,500 [(45
hrs. x $84 x 1.617) + (40 hrs. x $84)]. The annualized cost is
approximately $700 ($9,500 x 0.07).
Final Sec. 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 x 40 hrs. x $74.32
per hr.) + (0.25 hrs. x $26.37 per hour x 4 copies) + (250 pages x
$0.15 cost per page x 4 copies) + ($5 x 4 copies)]. The annualized cost
is approximately $200 ($3,200 x 0.07).
Final Sec. 74.16(a) requires that MSHA and NIOSH each retain one
CPDM that is submitted with the application. In addition, final Sec.
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 x $10,000 per CPDM).
The annualized cost is $2,100 ($30,000 x 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.
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 Sec. 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 x 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. x $74.32)
[[Page 17523]]
+ (0.25 hrs. x $26.37 x 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
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, Sec. 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.
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
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 Sec. 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.
F. Executive Order 13132: Federalism
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
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.
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.
0
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
Sec. 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.
Sec. 74.2 Definitions.
(a) Accuracy: the ability of a continuous personal dust monitor
[[Page 17524]]
(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
Sec. 74.3 Sampler unit.
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.
Sec. 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
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 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
[[Page 17525]]
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 pre-weighed 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 cyclone-cassette
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.
(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.
Sec. 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 Sec. 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.
Sec. 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 Sec. 74.13 of this part.
Subpart C--Requirements for Continuous Personal Dust Monitors
Sec. 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 in
the normal working conditions of coal mines.
(b) Ergonomic design testing. Prior to submitting an application
under Sec. 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
Sec. 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 Sec.
74.8, for an end-of-shift average measurement, for concentrations
within a range from 0.2 to 4.0 mg/m\3\ for respirable coal mine dust.
For end-of-shift average concentrations exceeding 4.0 mg/m\3\, the CPDM
shall provide a reliable
[[Page 17526]]
indication that the concentration exceeded 4.0 mg/m\3\.
(e) Environmental conditions. The CPDM shall operate reliably and
accurately as specified under Sec. 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. http://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:
http://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 radio-frequency 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, 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 Varemb[eacute], P.O. Box 131, CH-1211 GENEVA 20, Switzerland.
http://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:
http://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 Sec. 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 Sec. 74.8 of
this-subpart:
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Vibration............................ Mil-Std-810F, 514.5.... U.S. Highway Vibration, 1 Hours/Axis, 3 Axis;
Restrained Figure Total Duration = 3
514.5C-1. Hrs, equivalent to
1,000 miles.
Drop................................. 3-foot drop onto bare In standard in-use 1 drop per axis (3
concrete surface. configuration. total).
----------------------------------------------------------------------------------------------------------------
(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. http://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:
http://www.archives.gov/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/m\3\) 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 atmosphere of up to 4.0 mg/m\3\. 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
[[Page 17527]]
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.
Sec. 74.8 Measurement, accuracy, and reliability requirements.
(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/m\3\; 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/m\3\ for an 8-hour period.\1\
---------------------------------------------------------------------------
\1\ The equivalent dust concentration range to the 8-hour range
of 0.2 - 4 mg/m\3\ 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 x (0.2 - 4 mg/m\3\) = 1.6 -
32 mg/m\3\; for a two-hour measurement, the applicable concentration
range would be calculated as: 8 hours/2 hours x (0.2 - 4 mg/m\3\) =
0.8 - 16 mg/m\3\; for a 4-hours measurement, the equivalent range
would be: 0.4 - 8 mg/m\3\; * * * etc. A CPDM must perform
accurately, as specified, for intrashift measurements within such
equivalent concentration ranges.
---------------------------------------------------------------------------
(c) Reliability of measurements. The CPDM shall meet the accuracy
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/m\3\ 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/m\3\ 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 Sec. 74.7(e) and (g)) shall be determined
using the NIOSH testing procedure, ``Continuous Personal Dust Monitor
Accuracy Testing,'' June 23, 2008, available at: http://www.cdc.gov/niosh/mining/pubs/pubreference/outputid3076.htm. All testing results
shall be submitted to NIOSH in writing on the application filed under
Sec. 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. http://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:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
Sec. 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 Sec. 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. http://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:
http://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
[[Page 17528]]
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.
Sec. 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.
Sec. 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 Sec. Sec. 74.7-74.8 of
this part, with the exception of durability testing, which shall be
conducted by NIOSH as specified in Sec. 74.7(g) of this part.
Applicant testing 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 Sec. Sec. 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 Sec. 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
Sec. 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.
Sec. 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 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 Sec. 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 Sec. 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.
Sec. 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.
[[Page 17529]]
Sec. 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 full-scale 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.
Sec. 74.16 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:
http://www.cdc.gov/niosh/mining.
Sec. 74.17 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.
(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 Sec. 74.11(d).
Sec. 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