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Secretary of Labor Hilda L. Solis
     DOL Home > Federal Register > By Agency > MSHA
MSHA Final Rules

Coal Mine Dust Sampling Devices   [4/6/2010]
[PDF]
FR Doc 2010-7308
[Federal Register: April 6, 2010 (Volume 75, Number 65)]
[Rules and Regulations]               
[Page 17511-17529]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ap10-12]                         


[[Page 17511]]

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Part III





Department of Labor





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Mine Safety and Health Adminisration



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30 CFR Parts 18, 74, and 75



Coal Mine Dust Sampling Devices; High-Voltage Continuous Mining Machine 
Standard for Underground Coal Mines; Final Rules


[[Page 17512]]


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DEPARTMENT OF LABOR

Mine Safety and Health Adminisration

30 CFR Part 74

RIN 1219-AB61

 
Coal Mine Dust Sampling Devices

AGENCY: Mine Safety and Health Administration, Labor.

ACTION: Final rule.

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SUMMARY: This final rule revises requirements that the Mine Safety and 
Health Administration (MSHA) and the National Institute for 
Occupational Safety and Health (NIOSH) use to approve sampling devices 
that monitor miner exposure to respirable coal mine dust. The final 
rule updates approval requirements for the existing ``coal mine dust 
personal sampler unit'' to reflect improvements in this sampler over 
the past 15 years. The final rule also establishes criteria for 
approval of a new type of technology, the ``continuous personal dust 
monitor,'' which is worn by the miner and will report dust exposure 
levels continuously during the shift.

DATES: This final rule is effective June 7, 2010.
    The incorporation by reference of certain publications listed in 
the rule is approved by the Director of the Federal Register as of June 
7, 2010.

FOR FURTHER INFORMATION CONTACT: Patricia W. Silvey, Director, Office 
of Standards, Regulations, and Variances, MSHA, at 
silvey.patricia@dol.gov (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\
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    \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).
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    Since 1970, coal mine operators and MSHA have used approved coal 
mine dust personal sampler units (CMDPSUs) to determine the 
concentration of respirable dust in coal mine atmospheres. These 
devices sample the mine atmosphere by drawing mine air through a filter 
cassette that collects respirable coal mine dust. At the end of a full 
shift or 8 hours, whichever time is less, the cassette is sent to MSHA 
for processing. Each cassette is weighed under controlled conditions to 
determine the average concentration of respirable coal mine dust to 
which the affected miners were exposed.
    In the 1990s, NIOSH began research and development to produce a 
prototype technology for a new type of personal dust monitor that could 
provide readings of dust levels in the mine immediately during the 
shift and at the end of the shift. This would eliminate the delay in 
obtaining an offsite laboratory analysis which requires days before the 
results are made available to the mine operator and MSHA. The promise 
of the new technology, which is referred to generically as a 
``continuous personal dust monitor'' (CPDM), was that it could allow 
mine operators to promptly identify and respond to dust exposures 
exceeding the applicable MSHA standards. With this new technology, 
operators could evaluate causes of overexposures, implement control 
measures to reduce exposures, and adjust such controls as necessary.
    In 2003, Rupprecht and Patashnick Co., Inc., now Thermo Fisher 
Scientific, developed an initial prototype CPDM under contract with 
NIOSH. The prototype incorporated a unique mechanical mass sensor 
system called Tapered Element Oscillating Microbalance (TEOM[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\
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    \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.
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    In 2006, NIOSH, in collaboration with MSHA, the mining industry, 
and labor, completed extensive testing to evaluate the accuracy of the 
pre-commercial CPDM and its suitability for use in underground coal 
mines in terms of ergonomics and durability. The testing verified that 
the device achieved with 95 percent confidence end-of-shift 
measurements within  25 percent of reference measurements 
\3\ taken in a variety of coal mines. In addition, the testing 
demonstrated that the device was acceptable to miners from an 
ergonomics standpoint, and was sufficiently durable to withstand the 
conditions of transportation and use in the mines.\4\
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    \3\ Reference measurements were established using multiple 
gravimetric samplers in dust exposure chambers for laboratory 
testing and using CMDPSUs in a variety of coal mines for field 
testing.
    \4\ See: Volkwein, J.C., R.P. Vinson, S.J. Page, L.J. 
McWilliams, G.J. Joy, S.E. Mischler, and D.P. Tuchman. Laboratory 
and field performance of a continuously measuring personal 
respirable dust monitor. CDC RI 9669. September 2006. 47 pp. and 
Volkwein, J.C., R.P. Vinson, L.J. McWilliams, D.P. Tuchman, and S.E. 
Mischler. Performance of a New Personal Respirable Dust Monitor for 
Mine Use. CDC RI 9663. June 2004.
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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