[Federal Register Volume 74, Number 11 (Friday, January 16, 2009)]
[Proposed Rules]
[Pages 2915-2931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-534]


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DEPARTMENT OF LABOR

Mine Safety and Health Adminisration

30 CFR Part 74

RIN 1219-AB61


Coal Mine Dust Personal Monitors

AGENCY: Mine Safety and Health Administration (MSHA), Labor.

ACTION: Proposed rule and close of comment period.

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SUMMARY: This proposed rule would revise requirements that the Mine 
Safety and Health Administration (MSHA) and the National Institute for 
Occupational Safety and Health (NIOSH) apply to approve sampling 
devices that monitor miner exposure to respirable coal mine dust. The 
proposal would establish criteria for approval of a new type of 
technology, the ``continuous personal dust monitor,'' which would be 
worn by the miner and would report exposure to dust levels continuously 
during the shift. In addition, the proposal would update application 
requirements for the existing ``coal mine dust personal sampler unit'' 
to reflect improvements in this sampler over the past 15 years. This 
rulemaking is limited to approval requirements and does not address 
requirements concerning how sampling devices must be used to determine 
compliance, e.g., who and when to sample. Those requirements are 
addressed in existing 30 CFR parts 70, 71, and 90.

DATES: MSHA and NIOSH invite comments on this proposed rule from 
interested parties. All comments must be received by midnight Eastern 
Standard Time on March 17, 2009.

ADDRESSES: Comments must clearly be identified with ``RIN 1219-AB61'' 
and may be submitted to MSHA by any of the following methods:
    (1) Federal e-Rulemaking Portal: http://www.regulations.gov. Follow 
the instructions for submitting comments.
    (2) Electronic mail: <a href="/cdn-cgi/l/email-protection#6f1515223c272e422c0002020a011b1c2f0b000341080019"><span class="__cf_email__" data-cfemail="d5afaf98869d94f896bab8b8b0bba1a695b1bab9fbb2baa3">[email protected]</span></a>. Include ``RIN 1219-
AB61'' in the subject line of the message.
    (3) Facsimile: (202) 693-9441. Include ``RIN 1219-AB61'' in the 
subject line of the message.
    (4) Regular Mail: MSHA, Office of Standards, Regulations, and 
Variances, 1100 Wilson Blvd., Room 2350, Arlington, Virginia 22209-
3939.
    (5) Hand Delivery or Courier: MSHA, Office of Standards, 
Regulations, and Variances, 1100 Wilson Blvd., Room 2350, Arlington, 
Virginia 22209-3939. Sign in at the receptionist's desk on the 21st 
floor.
    Comments can be accessed electronically at http://www.msha.gov 
under the ``Rules and Regs'' link. MSHA will post all comments on the 
Internet without change, including any personal information provided. 
Comments may also be reviewed at the Office of Standards, Regulations, 
and Variances, 1100 Wilson Blvd., Room 2350, Arlington, Virginia. Sign 
in at the receptionist's desk on the 21st floor.
    MSHA maintains a list that enables subscribers to receive e-mail 
notification when rulemaking documents are published in the Federal 
Register. To subscribe to the list, go to http://www.msha.gov/subscriptions/subscribe.aspx.
    Information Collection Requirements: Comments concerning the 
information collection requirements of this proposed rule must be 
clearly identified with ``RIN 1219-AB61'' and sent to both the Office 
of Management and Budget (OMB) and MSHA. Comments to OMB may be sent by 
mail addressed to the Office of Information and Regulatory Affairs, 
Office of Management and Budget, New Executive Office Building, 725 
17th Street, NW., Washington, DC 20503, Attn: Desk Officer for MSHA. 
Comments to MSHA may be transmitted either electronically to <a href="/cdn-cgi/l/email-protection#84fefec9d7ccc5a9c7ebe9e9e1eaf0f7c4e0ebe8aae3ebf2"><span class="__cf_email__" data-cfemail="c5bfbf88968d84e886aaa8a8a0abb1b685a1aaa9eba2aab3">[email protected]</span></a>, by facsimile to (202) 693-9441, or by regular mail, 
hand delivery, or courier to MSHA, Office of Standards, Regulations, 
and Variances, 1100 Wilson Blvd., Room 2350, Arlington, Virginia 22209-
3939.

FOR FURTHER INFORMATION CONTACT: Patricia W. Silvey, Director, Office 
of Standards, Regulations, and Variances, MSHA, at 
<a href="/cdn-cgi/l/email-protection#32415b5e44574b1c425346405b515b5372565d5e1c555d44"><span class="__cf_email__" data-cfemail="384b51544e5d411648594c4a515b5159785c5754165f574e">[email protected]</span></a> (e-mail), (202) 693-9440 (voice), or (202) 693-
9441 (facsimile).

SUPPLEMENTARY INFORMATION: The outline of this proposal is as follows:

I. Background
    A. Introduction
    B. Need for Rulemaking
    C. Public Hearings
II. Summary of Proposed Rule
III. Section-by-Section Analysis
    A. Section 74.1 Purpose
    B. Section 74.2 Definitions
    C. Section 74.3 Sampler unit
    D. Section 74.4 Specifications of sampler unit
    E. Section 74.5 Tests of coal mine dust personal sampler units
    F. Section 74.6 Quality control
    G. Section 74.7 Design and construction requirements
    H. Section 74.8 Measurement, accuracy, and reliability 
requirements
    I. Section 74.9 Quality assurance
    J. Section 74.10 Operating and maintenance instructions
    K. Section 74.11 Tests of the Continuous Personal Dust Monitor
    L. Section 74.12 Conduct of tests; demonstrations
    M. Section 74.13 Applications
    N. Section 74.14 Certificate of approval
    O. Section 74.15 Approval labels
    P. Section 74.16 Material required for record
    Q. Section 74.17 Changes after certification
    R. Section 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

[[Page 2916]]

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. Background

A. Introduction

    The Coal Mine Health and Safety Act of 1969, the predecessor to the 
Federal Mine Safety and Health Act of 1977, specified that the average 
concentration of respirable coal mine dust be measured by a device 
approved by the Secretary of Interior and the Secretary of Health 
Education and Welfare (Secretaries). In 1972, the Secretary of Interior 
promulgated 30 CFR part 74--Coal Mine Dust Personal Sampler Units. That 
rulemaking established the requirements for joint approval of the 
device by both Secretaries and specified that MSHA's role was to 
determine if the unit was intrinsically safe. NIOSH would determine if 
the unit 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 precisely weighed under controlled 
conditions to determine the average concentration of respirable coal 
mine dust to which the miner was 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 of 
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 would allow 
mine operators to identify and immediately respond to high dust 
exposures. Operators would evaluate causes of over exposures, implement 
solutions to reduce exposures, and adjust them as necessary.
    In 2003, a private sector monitoring technology company, Rupprecht 
and Patashnick Co., Inc., now Thermo Fisher Scientific, developed an 
initial prototype CPDM under contract with NIOSH. The prototype 
incorporates 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 concentration of respirable dust in the mine atmosphere is 
then determined by a computer internal to the monitor, which divides 
the mass of dust collected by the volume of mine air that passed 
through the system during the time period sampled. The result is 
reported on the monitor'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 by 
the computer for downloading onto any personal computer with a 
Microsoft Windows[supreg] operating system using accompanying software. 
The prototype also projects the end-of-shift average dust concentration 
continuously during the shift. These projections can serve as a warning 
system to mine operators, assisting them in recognizing exposure levels 
that, if not reduced, would result 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 and stakeholders 
representing the mining industry and labor, completed extensive testing 
to evaluate the accuracy of the pre-commercial unit and its suitability 
for use in the coal mine in terms of ergonomics and durability. The 
testing verified that the device achieved with 95 percent confidence 
end-of-shift measurements within <plus-minus>25 percent of reference 
measurements \3\ taken in a variety of coal mines. The testing also 
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. Thus, the testing 
demonstrated to MSHA and NIOSH that it is technically feasible to 
introduce the CPDM as an innovative new measurement tool for the 
protection of coal miners.\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. Need for Rulemaking

    Existing 30 CFR part 74, ``Coal Mine Dust Personal Sampler Units,'' 
specifies procedures and requirements by which MSHA and NIOSH \5\ 
jointly approve the design, construction, performance, and 
manufacturing quality of the CMDPSU. These regulatory requirements, 
which were issued in 1972, are design-specific and do not permit the 
approval of any monitoring device of a different design. The CMDPSU is 
currently the only personal dust monitor approved for use in coal mines 
to monitor miners' exposure to respirable coal mine dust.
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    \5\ MSHA's role is to approve the ``intrinsic safety'' of the 
device, which assures that the device could be operated safely in 
the potentially explosive atmosphere of an underground coal mine.
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    As discussed above, NIOSH, in collaboration with a private 
technology firm, MSHA, and representatives of industry and labor, has 
developed and evaluated a prototype for a new type of personal 
monitoring device, the ``continuous personal dust

[[Page 2917]]

monitor''(CPDM). The unit is capable of continuously monitoring and 
immediately displaying concentrations of respirable coal mine dust 
during the shift and also provides the end-of-shift summary 
measurements.
    MSHA and NIOSH recognize that the ability to measure in real time 
the amount of respirable coal mine dust to which a miner is exposed 
offers the best solution for protecting miners from occupational lung 
disease. Knowing the actual respirable dust level and being able to 
project the end-of-shift dust exposure continuously during the shift 
will enable mine operators to take immediate action to prevent 
overexposure. This new technology can be a critical element in the 
strategy used by mine operators and MSHA to control respirable dust 
exposure.
    The 1995 Advisory Committee on the Elimination of Pneumoconiosis 
Among Coal Mine Workers, which was established by the Secretary of 
Labor to make recommendations for improving the program to control 
respirable coal mine dust, also supported the use of continuous 
monitoring devices. That committee, which included representatives from 
the mining industry, the United Mine Workers of America and technical 
experts with no economic interests in mining, unanimously concluded 
that continuous monitors have the potential to improve monitoring of 
the work environment significantly and to contribute to the effective 
control of exposure.
    However, existing MSHA standards and procedures for operator and 
agency monitoring of respirable coal mine dust specify that sampling 
must be conducted with an approved sampling device. The new CPDM 
technology cannot be approved under the existing part 74 requirements. 
MSHA and NIOSH are proposing to revise part 74 to accommodate this new 
technology.
    While the proposed requirements under part 74 would allow the 
Secretaries to approve new types of sampling devices, existing 
standards under 30 CFR parts 70, 71 and 90 would need to be revised 
prior to using any new monitoring technology in coal mines for 
compliance purposes. Compliance issues are not within the scope of this 
rulemaking.
    The proposed part 74 addresses performance-based and other 
requirements by which MSHA and NIOSH would approve CPDM devices for use 
in coal mines. The performance-based approach would allow for continued 
innovation in CPDM designs, which would accommodate improvements or 
alternative designs in the technology to be introduced in the future.
    MSHA and NIOSH are also proposing in this rulemaking to revise the 
existing requirements in part 74 applicable to the approval of CMDPSUs. 
This proposed revision reflects improvements incorporated voluntarily 
by the manufacturer into the sampler design since the mid-1990s.

C. Public Hearings

    MSHA and NIOSH will hold two hearings to provide the public with an 
opportunity to present oral statements, written comments, and other 
data on this rulemaking. One of the hearings will be held in the 
eastern part of the United States and the other will be held in the 
west. The hearings will be announced in a separate Federal Register 
notice. As indicated above, the nature of this rulemaking involves 
establishing performance-based approval requirements for manufacturers 
of monitoring devices. MSHA and NIOSH anticipate that two hearings will 
allow for full public input to the proposed rule.

II. Summary of Proposed Rule

    This proposed rule would revise requirements for the approval of 
personal dust monitoring devices in 30 CFR part 74, currently titled 
``Coal Mine Dust Personal Sampler Units,'' and would retitle the part 
``Coal Mine Dust Personal Monitors.'' This rulemaking would establish 
performance-based and other requirements for approval of the new CPDMs. 
The requirements would facilitate innovation among direct-reading 
device manufacturers for the continued improvement of this technology.
    The proposal also updates the existing design-based requirements 
for CMDPSUs. It is not the intent of this rulemaking to require changes 
in the current technology of CMDPSUs, although MSHA and NIOSH invite 
the public to comment on any aspect of this rulemaking.
    Part 74 would be renumbered in this rulemaking as follows:
    Subpart A--Introduction--Purpose and definitions.
    Subpart B--Requirements for Coal Mine Dust Personal Sampler Unit--
specifications for existing technology.
    Subpart C--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

    The section-by-section analysis below describes and explains the 
proposed provisions of part 74. The proposed regulatory text is 
provided in the last section of this notice.
    Subpart A--Introduction would be a new section which would cover 
the purpose and definitions.

A. Section 74.1 Purpose

    Proposed Sec.  74.1 describes the purpose of the rule and would be 
essentially unchanged from the existing provision. The scope has been 
expanded to include both CPDMSU and CPDM technology.

B. Section 74.2 Definitions

    Proposed Sec.  74.2 would be a new section to define key terms in 
the proposal.
    Proposed paragraphs (a) and (b) would define the concepts of 
accuracy and bias as they apply to measurement devices such as the 
CPDM. They are key performance parameters for testing and approving of 
the CPDM.
    Proposed paragraphs (c) and (d) would define the two types of 
sampling devices covered by this proposal, the CMDPSU and the CPDM. The 
definitions are included to distinguish between the two types of dust 
monitoring technology.
    Proposed paragraph (e) would define the International Organization 
for Standardization (ISO), a voluntary consensus standards-setting 
organization. An ISO standard is relied on in this proposal (see Sec.  
74.9).
    Proposed paragraph (f) would define the concept of precision as it 
applies to the CPDM. Precision is the third key performance parameter 
for the testing and approval of CPDMs.
    Subpart B contains the requirements that apply to the CMDPSU.

C. Section 74.3 Sampler Unit

    Proposed Sec.  74.3 would renumber existing Sec.  74.2, which 
specifies the major components of a CMDPSU and would be substantially 
unchanged from the existing provisions.

D. Section 74.4 Specifications of Sampler Unit

    Proposed Sec.  74.4 would renumber existing Sec.  74.3 and update 
the requirements of the existing provision to reflect the sampling 
technology approved for use in coal mines today.
    Existing paragraph (a) would update the existing design 
requirements for the pump unit of the CMPDSU.
    Proposed paragraph (a)(1) would update pump dimensions to reflect 
the smaller size of the device used today: 4 inches (10 centimeters) in 
height; 4

[[Page 2918]]

inches (10 centimeters) in width; and 2 inches (5 centimeters) in 
thickness. The existing specifications allow for dimensions of up to 8 
inches (20 centimeters), 6 inches (15 centimeters), and 4 inches (10 
centimeters), respectively.
    Proposed paragraph (a)(2), which specifies the maximum pump weight, 
would be updated to reflect the reduction in the weight of these units, 
from 4 pounds (1.814 kilograms) to 20 ounces (567 grams).
    Proposed paragraph (a)(3), which specifies the characteristics of 
the construction of the pump case and pump components, would be updated 
to add the requirement that they must protect against radio frequency 
interference and electromagnetic interference. This improvement, 
implemented in the 1990s, is necessary to 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 proposal would retain the existing requirement that 
the case and components of the pump unit must be of durable 
construction and tight-fitting.
    Proposed paragraphs (a)(4) and (a)(5) would be unchanged from the 
existing provisions. These paragraphs require that the pump exhaust 
into the pump case to maintain a slight positive pressure and the pump 
unit be equipped with an ON/OFF switch to protect against accidental 
operation during use.
    Existing paragraph (a)(6), which specifies pump design 
characteristics for flow rate adjustment, would be revised to provide 
more flexibility in the design to avoid inadvertent changes in the flow 
rate. The existing specification requires the use of a flow rate 
adjusting ``tool'' to prevent inadvertent changes in the flow rate. 
This specific requirement would be deleted.
    Proposed paragraph (a)(7), like the existing provision, would 
require that the power supply for the pump be a suitable battery 
located in the pump case or in a separate case which is attached by a 
permissible electrical connection.
    Existing paragraph (a)(8), which concerns regulating the effect of 
pulsation on the flow rate of the pump, would be revised to delete the 
reference to the expired date (July 1, 1974) in paragraph (ii).
    Proposed paragraphs (9) and (10), like the existing provisions, 
would require that the pump unit be equipped with a belt clip and that 
a suitable connection be provided to allow the battery to be recharged 
without removing it from the pump case or battery case.
    Existing paragraph (a)(11), which requires a visual indication of 
the flow rate and specifies the calibration of the flow rate indicator, 
would be updated to require that it be calibrated within <plus-minus>5 
percent at 2.2, 2.0, and 1.7 liters per minute, versus at 2.0, 1.8, and 
1.6 liters per minute as required under the existing rule. The proposed 
higher flow rates better reflect the operating flow rate range 
specified in proposed paragraph (a)(12).
    Proposed paragraph (a)(12), like the existing provision, would 
require that the pump operate within a range from 1.5 to 2.5 liters per 
minute and be adjustable over this range.
    Existing paragraph (a)(13), which requires the flow rate to remain 
consistent or stable during sampling, would be revised to require that 
the consistency be sustained over at least a 10-hour period, versus an 
8-hour period under the existing provision. This change reflects the 
operating performance of these devices today and the prevalence of 10-
hour shifts in coal mining. The existing requirements for readjustment 
of the flow rate would be deleted since all units currently in use have 
constant flow pumps and do not require readjustment.
    Proposed paragraph (a)(14) would be a new provision that would 
require a flow restriction indicator. This new requirement would 
reflect current technology and would be incorporated to prevent the 
shutdown of a pump and loss of a sample if the flow restriction is not 
corrected. This helps assure that the mine atmosphere is accurately 
sampled. The requirements in existing paragraph (a)(14), which address 
duration of operation of the pump unit, would be transferred to new 
proposed paragraph (a)(15).
    Existing paragraph (a)(14) would be redesignated as paragraph 
(a)(15). This provision would specify 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 would be revised to reflect the extended and 
higher level of performance achieved by existing technology. This 
increased capacity is necessary to enable the sampling of work shifts 
longer than 8 hours, which are prevalent today. The existing resistance 
requirement for 8 hours of operation at a flow rate of 2 liters per 
minute would be increased from 4 inches (10 centimeters) of water to 25 
inches (64 centimeters) of water, as measured at the inlet of the pump. 
The proposal adds a new provision that reflects existing technology by 
requiring the pump to operate for 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.
    Proposed paragraph (a)(16) is a new provision which would require 
the pump unit to be equipped with a low battery indicator. This 
provision reflects existing technology and is an important feature for 
ensuring the successful sampling of the mine atmosphere. Failure of the 
battery during sampling results in invalidation of the sample and the 
inability to determine the respirable coal mine dust concentration 
measured by the CMDPSU.
    Proposed paragraph (a)(17) is a new provision which would require 
the pump unit to be equipped 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 proposal reflects existing technology and is necessary to 
determine if sampling was conducted for the required duration, which is 
essential for the accurate measurement of the respirable coal mine dust 
concentration that occurred during the work shift.
    Proposed paragraph (b) addresses requirements for the sampling head 
assembly of the CMDPSU.
    Proposed paragraphs (b)(1) and (b)(2)(i), retain the requirements 
of the existing provisions for the cyclone and the filter (with a minor 
wording change).
    Proposed paragraph (b)(2)(ii), which specifies characteristics of 
the capsule enclosing the filter, would be revised to require that the 
capsule prevent visual inspection of the filter surface or filter 
loading. This reflects existing technology and is intended to safeguard 
the accuracy, integrity, and validity of the sample.
    Existing paragraph (b)(2)(iii), which specifies characteristics of 
the cassette enclosing the capsule, would be revised to add the 
requirement that the cassette be designed to prevent intentional or 
inadvertent alteration of the dust deposited on the filter. The 
proposal would also add a requirement that the capsule covers be 
designed to prevent reversal of the air flow through the capsule or 
other means of removing dust collected on the filter. These provisions 
would reflect existing technology and are intended to safeguard the 
accuracy, integrity, and validity of the sample.
    Proposed paragraphs (b)(3) and (b)(4) are the same as the existing 
provisions. Proposed paragraph (b)(3) relates to the connections 
between the cyclone vortex

[[Page 2919]]

finder and the capsule and between the capsule and hose. Proposed 
paragraph (b)(4) requires that the clamping and positioning of the 
cyclone-cassette assembly be firmly in contact, airtight and be 
attached firmly to a backing plate.
    Existing paragraph (b)(5), which specifies the characteristics of 
the hose connecting the sampler pump and the filter assembly, would be 
revised to require that the hose be clear plastic. This proposed 
revision would reflect existing technology and allow the examination of 
the external tubing to assure that it is clean and free of leaks, as 
accumulations or leaks could affect the accuracy of the sampling 
results.
    Proposed paragraph (c) would address requirements for the battery 
charger of the CMDPSU.
    Existing paragraph (c)(1), which specifies the voltage and 
frequency requirements for the battery charger, would be updated to 
reflect currently used power supply voltage of 110 (VAC) (nominal), 
versus 117 volt in the existing standard.
    Proposed paragraphs (c)(2) and (c)(3) are identical to existing 
(c)(2) and (c)(3), which require that the battery charger be provided 
with a cord and polarized connector and that it be fused and have a 
grounded power plug.
    Existing paragraph (c)(4), which specifies the recharging rate of 
the battery charger, would be revised to reflect current technology, 
which fully recharges the battery in the pump unit within 16 hours.

E. Section 74.5 Tests of Coal Mine Dust Personal Sampler Units

    Proposed Sec.  74.5 renumbers existing Sec.  74.4 and would provide 
authority for NIOSH and MSHA testing to evaluate whether the CMDPSU 
meets the requirements of this rule. This section has not been 
substantively changed.

F. Section 74.6 Quality Control

    Proposed Sec.  74.6 is derived from existing Sec.  74.6(d) 
regarding applications. The proposal makes only clarifying changes by 
referencing proposed Sec.  74.13 (filing applications).

Subpart C--Requirements for Continuous Personal Dust Monitors (CPDMs)

G. Section 74.7 Design and Construction Requirements

    Proposed Sec.  74.7 would provide design and construction 
requirements for the CPDM. The requirements would be performance 
oriented to the extent possible to allow manufacturers flexibility for 
continued innovation in this new technology. Design-specific 
requirements are proposed when necessary and appropriate for assuring 
miner safety or accommodating mining conditions.
    Proposed paragraph (a) would require that the CPDM be designed and 
constructed to allow miners to work safely and be suited to work 
requirements and working conditions of coal mining.
    Proposed paragraph (b) addresses ergonomic design and would require 
that, prior to filing an application under proposed 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 would be required to include provisions for testing in one or 
more active mines under routine operating conditions. NIOSH would 
approve the protocol prior to testing and would review the written 
results as a component of the application for approval. NIOSH would 
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 would 
reserve 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.''
    Proposed paragraph (c) would require 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 other means. The 
result should be that the total extra weight is no more than 2 kg more 
than the weight normally carried by miners without the CPDMs. The 2-kg 
limit is proposed based on the professional judgment of MSHA and NIOSH 
field 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 proposed limit accommodates the weight of the prototype CPDM, which 
in NIOSH testing was worn and used by miners for full shifts and proved 
to be acceptable. The prototype weighed approximately 3 kg, but served 
to power the cap lamp as well, so that a separate battery was not 
required for the cap lamp. In combination, the prototype with its dual-
use battery increased the personal equipment load of the miners by less 
than 2 kg.
    Proposed paragraph (d) would require that the CPDM provide accurate 
measurements of respirable coal mine 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<SUP>3</SUP> when quartz 
content does not exceed 5%) for an end-of-shift average measurement, 
and provide a reliable indication when the concentration exceeds 2 
times the PEL.
    Proposed paragraph (e) would require that the CPDM operate reliably 
and accurately within the full range of environmental conditions 
encountered in coal mines. It would require 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 proposed parameters, in 
addition to those in proposed paragraphs (f) and (g) of this section, 
would address the full range of environmental conditions found in coal 
mines. MSHA and NIOSH specifically solicit comments on these 
parameters, as well as any others that might be appropriate.
    Proposed paragraph (f) would require that the CPDM meet standards 
for the control of and protection from electromagnetic interference 
established by the American National Standards Institute (ANSI), the 
Federal Communications Commission (FCC), and the International 
Electrotechnical Commission (IEC). The FCC is an independent federal 
agency that regulates radiofrequency emitting devices. ANSI and IEC are 
voluntary standards-setting organizations, the former covering a wide 
array of technical and management fields 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.
    Proposed paragraph (g) would require that the CPDM be designed and 
constructed to remain intrinsically safe and accurate after undergoing 
vibration and shock tests representative of conditions of use in the 
mine. In testing for vibration, NIOSH proposes to use Military Standard 
810F, 514.5. This test

[[Page 2920]]

would measure 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 shock test that NIOSH would apply would involve 
three 3-foot drops onto a bare concrete surface (one drop testing each 
axis of the device). This test would represent the occasional drops and 
knocking of the device expected during use of the device by miners. 
NIOSH would conduct the testing regime on test units prior to further 
testing by the applicant under Sec.  74.8 and intrinsic safety testing 
by MSHA under Sec.  74.11(d).
    Proposed paragraphs (h)(1) and (2) would require adequate 
legibility or audibility of monitoring results, computer (i.e., 
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<SUP>3</SUP>). The proposed visibility requirement for a minimum 
digital character height of 6 millimeters is based on testing during 
CPDM prototype development. All other proposed requirements in this 
provision allow flexibility for new innovative designs that would 
provide timely, reliable, and appropriately quantified information.
    Proposed paragraph (i) would require that the power source for the 
CPDM have sufficient capacity to enable continuous sampling for 12 
hours in a coal mine dust atmosphere of 2 times the PEL. This 
requirement would provide reasonable assurance that the power supply 
would be sufficient to enable accurate measurement of respirable dust 
concentrations for 12 hour work shifts, which are the longest current 
work shifts in U.S. coal mines. If the dust concentrations in a mine 
exceeded 4 mg/m<SUP>3</SUP> continuously for 12 hours, a power supply 
meeting this proposed standard might not be sufficient to sustain 
monitoring for the complete shift, since a higher dust concentration 
would place higher power demands on certain types of filtering 
technology. Nevertheless, this proposed standard would be sufficient to 
assure that the CPDM would have the power capacity to measure high dust 
concentrations during the shift, and to cumulatively document that they 
substantially exceeded the PEL for the full shift. These are the 
essential performance considerations for the CPDM for continuous and 
end-of-shift monitoring.
    Proposed paragraph (i) also would require that a CPDM that uses a 
rechargeable battery must be recharged using the standard power 
supplies in mines (110 VAC).
    Proposed paragraph (j) would require that if a CPDM uses a pump to 
sample the atmosphere, it must perform with a flow stability within 
<plus-minus> five percent of the calibrated flow for a continuous 
duration of 12 hours.\6\ This requirement is integral to achieving 
representative, accurate measurements of respirable coal mine dust 
concentrations. The paragraph would also require that the applicant 
specify in the calibration instructions for the device the flow 
calibration maintenance interval required to achieve this level of flow 
stability.
---------------------------------------------------------------------------

    \6\ NIOSH Manual of Analytic Methods, Method 0600, Issue 3, 
Fourth Edition, January 15, 1998.
---------------------------------------------------------------------------

    Proposed paragraph (k) would require that a CPDM using a 
rechargeable battery have a feature to indicate to the user that the 
unit is adequately recharged to provide accurate measurements for an 
entire shift of 12 hours. This feature is necessary to avoid monitoring 
failures due to power deficiency. The requirement of ``* * * under 
normal conditions of use'' is included to account for the possibility 
that exceptionally high dust concentrations, exceeding 4 mg/
m<SUP>3</SUP>, which normally should not occur, might deplete the 
battery power before the end of the shift. CPDM battery power does not 
have to be sufficient to continue accurate monitoring under such 
excessive exposure conditions for an entire 12-hour shift, since the 
non-compliant exposure would be measured and documented within the 
initial portion of the shift during which the device would operate with 
adequate battery power.
    Proposed paragraph (l) sets forth requirements for CPDMs that share 
components with other personal equipment carried by an underground 
miner, such as cap lamps.
    Proposed paragraph (l)(1) would require that the applicant obtain 
any necessary approvals required for the non-CPDM equipment prior to 
receiving final certification of the CPDM from NIOSH. This provision 
will enable NIOSH to assure that all approvals for devices not approved 
by NIOSH are obtained, as appropriate.
    Proposed paragraph (l)(2) would require that the CPDM operate 
effectively with the integrated function or functions. This provision 
would assure that the CPDM is not compromised by integration of 
functions and provide reasonable assurance that the integrated non-CPDM 
functions operate as intended.
    Proposed paragraph (m) would specify performance requirements that 
would help assure that CPDMs are designed to prevent intentional 
tampering and limit inadvertent altering of monitoring results. It 
would require that the CPDM have a safeguard or indicator which either 
prevents altering the measuring or reporting function of the device or 
indicates if these functions have been altered.
    This proposed provision is intended to direct manufacturers to 
design tampering safeguards and indicators that address foreseeable 
actions by users. In addition, the provision would allow NIOSH to 
require, to the extent feasible, changes in the design of an already 
approved device, following the discovery of tampering methods or 
inadvertent actions that can alter monitoring results.
    Proposed paragraph (n) would require that the CPDM be designed to 
assure 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 might adversely affect 
the operability and monitoring accuracy of a CPDM.

H. Section 74.8 Measurement, Accuracy, and Reliability Requirements

    Proposed Sec.  74.8 is new and would establish the performance 
requirements for CPDMs. These proposed requirements reflect current 
evaluation methods regarding the assessment of direct reading monitors. 
These methods have been summarized and issued as general guidelines by 
NIOSH (Components for the Evaluation of Direct-Reading Monitors for 
Gases and Vapors).\7\ The proposed requirements also reflect the state-
of-the-art technology of the CPDM prototype. Accordingly, this proposed 
rulemaking establishes a science-based, feasible baseline for the 
performance of this new CPDM technology. Upon request, NIOSH will 
provide a report on the performance of the prototype CPDMs, which are 
partially summarized in several peer-reviewed journal articles.\8\
---------------------------------------------------------------------------

    \7\ 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.
    \8\ 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.
---------------------------------------------------------------------------

    Proposed paragraph (a) would require that the CPDM be capable of 
measuring

[[Page 2921]]

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.\9\ The proposed rule provides a reasonably specific definition 
of the breathing zone to guide applicants.
---------------------------------------------------------------------------

    \9\ 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).
---------------------------------------------------------------------------

    Proposed paragraph (b) would provide requirements for the 
measurement accuracy of the CPDM.
    Proposed paragraph (b)(1) would require for full-shift measurements 
of 8 hours or more, a 95 percent confidence that the recorded 
measurements are within <plus-minus>25 percent of the true dust 
concentration, as determined by CMDPSU reference measurements, over a 
concentration range of 10% to 2 times the PEL. The specific quantified 
degree of accuracy proposed 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.\10\
---------------------------------------------------------------------------

    \10\ 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 proposed measurement range over which the CPDM must be accurate 
is also based on the current CPDM technology, as represented by the 
pre-commercial unit. This technology requires a minimum quantity of 
filter loading on the microbalance filter before the CPDM can measure 
accurately, distinguishing actual exposure quantities from small 
measurement variations due to imperfections of the CPDM equipment. The 
lower bound assures that accuracy is maintained for situations where 
silica is present and the permitted levels of respirable dust are 
reduced. Similarly, there is an upper bound of loading, which is likely 
to exceed the specified 4.0 mg/m<SUP>3</SUP> level,\11\ after which 
current CPDM technology may lose sensitivity as a result of the heavily 
loaded filter on the microbalance. Nonetheless, the proposed standard 
would assure that the range of average, full-shift dust concentrations 
over which the CPDM would perform accurately would be adequate to 
quantify full shift exposures that range from exceptionally low to 
exceptionally high, allowing for identification of overexposures.
---------------------------------------------------------------------------

    \11\ NIOSH testing of the CPDM prototype used 4.0 mg/
m<SUP>3</SUP> dust concentrations as the upper limit in challenging 
the device for accuracy. NIOSH did not conduct testing to identify 
the upper bound 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, proposed 
paragraph (b)(2) would require a 95 percent confidence that the 
recorded measurements are within <plus-minus>25 percent of the true 
dust concentration, as determined by CMDPSU reference measurements, 
over the dust concentration of 10% to 2 times the PEL for an 8-hour 
period. The proposal includes a formula for calculating the equivalent 
dust concentration range for assessing the accuracy of intra-shift 
measurements.
    Proposed paragraph (c) would require the CPDM to meet the accuracy 
requirements regardless of the variation in density, composition, size 
distribution of respirable coal mine dust particles, or presence of 
spray mist found in U.S. 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.
    Proposed paragraph (d) would establish a requirement for the CPDM 
to monitor with sufficient precision, meaning the degree to which it is 
able to closely replicate its measurement result, when monitoring 
identical dust concentrations. The proposed precision requirement is a 
relative standard deviation of less than 0.1275 without bias for 
multiple measurements. The proposed precision requirement will enable 
MSHA and mine operators to monitor changes in dust concentrations with 
reasonable confidence.
    Proposed paragraph (e) would require 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 shall be no greater than 10 percent. The 
proposal requires that measurement bias be constant over the range of 
dust concentration levels tested, between 10% and 2 times the PEL, for 
an 8-hour sampling period. The proposed bias requirement is sufficient 
to assure 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 and would also provide useful 
information to MSHA in support of compliance determinations and 
actions.
    Proposed paragraph (f) would require that applicants use the NIOSH 
testing procedure ``Continuous Personal Dust Monitor Testing 
Procedures'' to evaluate the accuracy (including reliability, 
precision, and bias) of a CPDM. The procedure is available at the NIOSH 
Web site: http://www.cdc.gov/niosh/mining. The protocol would assure 
that all CPDMs are evaluated consistently. NIOSH will provide 
assistance to applicants, as necessary, to make the arrangement of such 
testing feasible.

I. Section 74.9 Quality Assurance

    Proposed Sec.  74.9 is new and would establish quality assurance 
requirements for CPDM manufacturers.
    Proposed paragraph (a) would require that the applicant 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 proposed 
quality control system must be compliant with ISO Q9001-2000 standard 
established by the ISO.\12\ 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.
---------------------------------------------------------------------------

    \12\ 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.
---------------------------------------------------------------------------

    Proposed paragraph (a) would also require the applicant to submit a 
copy of the most recent registration under ISO Q9001-2000 to NIOSH, 
together with the application and, subsequent to

[[Page 2922]]

an approval, upon request. Registration under any updated version of 
ISO Q9001-2000 would be considered evidence of compliance with the ISO 
Q9001-2000 standard. Registration under the ISO quality management 
standard would represent evidence that the applicant has established a 
sound quality assurance program, and allow for the use of existing and 
widely available independent auditing services.
    Proposed paragraph (b) would require 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 
authority is essential in the event of substantial quality management 
problems in the manufacture of CPDMs.
    Proposed paragraph (c) would require a manufacturer to remedy a 
quality management deficiency identified by NIOSH or an independent 
audit within a reasonable time as determined by NIOSH. Refusal by the 
manufacturer would potentially result in the disapproval of a pending 
application or revocation of an approval until such time as NIOSH has 
determined that the deficiency is remedied. NIOSH has similar authority 
under its respirator certification program, although NIOSH has rarely 
had to employ it.

J. Section 74.10 Operating and Maintenance Instructions

    Proposed Sec.  74.10(a) is new and would require the manufacturer 
to include operating and maintenance instructions with each new CPDM 
unit sold.
    Proposed paragraph (b) would require the manufacturer to submit the 
instructions to NIOSH with the application for approval. It would also 
require that revised instructions be submitted if any substantive 
changes are made to the unit or the approved instructions after initial 
approval. Adequate instructions must be provided to facilitate 
effective use of sophisticated monitoring equipment. NIOSH review and 
approval of instructions would serve an important final quality control 
function for the manufacturer and assure that instructions are clearly 
written and easily understood. NIOSH has similar authority under its 
respirator certification program (42 CFR part 84).

K. Section 74.11 Tests of the Continuous Personal Dust Monitor

    This section is new and would establish testing requirements and 
services for the evaluation of CPDMs.
    Proposed paragraph (a) would require the applicant to conduct all 
testing regarding design, construction, and measurement accuracy 
requirements specified in Sec. Sec.  74.7-74.8 of this part, with the 
exception of durability testing under Sec.  74.7(g). It would further 
require that the testing be performed by an independent testing entity 
approved by NIOSH. This requirement would reduce concerns about 
conflicts of interest and would provide reasonable assurance of the 
quality of the testing and the reliability of the results.
    NIOSH considered the alternative of developing an in-house testing 
program for the evaluation of CPDMs. This alternative is not being 
proposed because NIOSH does not expect a substantial number of CPDM 
applications.
    Proposed paragraph (b) would provide for NIOSH to assist the 
applicant in identifying appropriate testing services and in assuring 
that testing protocols used by the independent testing entity are 
adequate. Applicants would be required to submit testing protocols to 
NIOSH prior to testing. It is unlikely that a manufacturer would be 
familiar with testing resources capable of addressing every element of 
the proposed requirements. NIOSH would be able to provide the applicant 
with information on private and university laboratories available for 
testing. In addition, NIOSH review of testing protocols would minimize 
the possibility of inadequate testing, which might result in the 
applicant incurring unnecessary delay and costs.
    Proposed paragraph (c) would require 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 would further establish the independence of 
the testing from the applicant.
    Under proposed paragraph (d) MSHA would evaluate and 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 such testing would not be approved for 
use in U.S. coal mines.

Subpart D--General Requirements for All Devices

L. Section 74.12 Conduct of Tests; Demonstrations

    Proposed Sec.  74.12, concerning the conduct of tests, renumbers 
existing Sec.  74.5 and would make clarifying changes to the existing 
provision. This section, which concerns the management of testing 
information prior to and after the issuance of a certificate of 
approval, would clarify that MSHA and NIOSH may reveal test protocols 
and results considered for approval of the device.

M. Section 74.13 Applications

    Proposed Sec.  74.13 would renumber existing Sec.  74.6 and add 
requirements necessary for filing an application for CPDMs. The 
application requirements for CMDPSUs remain substantively unchanged.
    Proposed paragraph (a) would require that a written application in 
duplicate be submitted to NIOSH and MSHA for approval of a CMDPSU 
(i.e., a total of four applications). Also, 10 complete units must be 
submitted to NIOSH with the application and one pump must be sent to 
MSHA. This is the same as the existing requirement for the CMDPSU.
    Proposed paragraph (b) would require the submission of an 
application in duplicate and 4 complete CPDM units, 3 to NIOSH and one 
to MSHA. The 4 units would allow MSHA to conduct intrinsic safety 
testing and NIOSH to evaluate compliance with the ``Design and 
Construction Requirements'' (See Sec.  74.7), verify any testing 
results, evaluate the use and maintenance instructions, and address 
quality assurance matters.
    Proposed paragraph (c) would require that drawings and 
specifications provided in the application identify the design, 
dimension, and materials of the CMDPSU or CPDM. This information is 
necessary for a complete evaluation of compliance with design and 
construction requirements proposed under this part.

N. Section 74.14 Certificate of Approval

    Proposed Sec.  74.14 renumbers existing Sec.  74.7 and would 
specify procedures by which NIOSH and MSHA would approve or disapprove 
an application for either a CMDPSU or CPDM. Proposed Sec.  74.14 is 
unchanged from the existing provision, except to expand the scope to 
include the CPDM.

O. Section 74.15 Approval Labels

    Proposed Sec.  74.15 renumbers existing Sec.  74.8 and would 
specify labeling procedures, requirements, and related obligations of 
the applicant. Proposed Sec.  74.15 is unchanged from the existing 
provision, except to expand the scope to include the CPDM.

[[Page 2923]]

P. Section 74.16 Material Required for Record

    Proposed Sec.  74.16 renumbers existing Sec.  74.9 and would 
provide for adequate records on each application, the return of CMDPSU 
or CPDM test units to the applicant, and the delivery of a commercially 
produced unit to NIOSH. Proposed Sec.  74.16 is unchanged from the 
existing provision, except to expand the scope to include the CPDM.

Q. Section 74.17 Changes After Certification

    Proposed Sec.  74.17 renumbers Sec.  74.10 and would specify 
procedures by which the applicant could seek to change features of an 
approved CMDPSU or CPDM. This section requires the manufacturer to file 
an application to change any feature and to test the modified device if 
NIOSH determines that testing is required. Proposed Sec.  74.17 is 
unchanged from the existing provision, except to expand the scope to 
include the CPDM.

R. Section 74.18 Withdrawal of Certification

    Proposed Sec.  74.18 renumbers Sec.  74.11 and would authorize 
NIOSH or MSHA to revoke for cause any certification of approval for a 
CMDPSU or CPDM. Proposed Sec.  74.18 is unchanged from the existing 
provision, except to expand the scope to include the CPDM.

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 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 proposed rule would not have annual effect of $100 million or 
more on the economy and, therefore, it is not an economically 
``significant regulatory action'' pursuant to section 3(f) of Executive 
Order 12866. MSHA, however, has concluded that the proposed rule is 
otherwise significant under Executive Order 12866 because it raises 
novel legal or policy issues.
    This proposed rule would update existing requirements for the 
approval of a CMPDSU to reflect the current state of this technology. 
The current approval holder of this device has voluntarily incorporated 
these improved requirements into the device. The proposal would also 
provide procedures and requirements by which NIOSH and MSHA could 
approve a new monitoring technology, CPDM devices, 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. No such device has been 
commercialized for the mining industry. This proposal does not 
establish compliance requirements. It addresses the approval of dust 
monitoring devices.

B. Benefits

    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. Respirable coal mine dust 
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), commonly 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. While significant progress has been made over the 
years in reducing respirable dust levels, coal miners continue to be at 
risk of developing CWP and silicosis, including progressive massive 
fibrosis (PMF), the most disabling and potentially fatal form of CWP. 
While there is no cure for these disabling lung diseases, they are 
entirely preventable.
    According to the U.S. Department of Labor's (DOL) Office of 
Workers' Compensation Programs, which administers the Black Lung 
benefits program to compensate victims of dust exposure in mines and 
certain eligible survivors of deceased miners, black lung benefits 
(monthly wage replacement and medical benefits) totaled $676 million in 
FY 2005.\13\
---------------------------------------------------------------------------

    \13\ U.S. DOL Employment Standards Administration, Office of 
Workers' Compensation Programs, Annual Report to Congress FY 2005, 
Submitted to Congress 2008.
---------------------------------------------------------------------------

    Under the Federal Coal Mine Health and Safety Act of 1969 (Pub. L. 
91-173), the predecessor to the Federal Mine Safety and Health Act of 
1977 (Pub. L. 95-164), the dust sampling technology used to measure 
miners' exposure to respirable coal mine dust has basically remained 
unchanged since 1970. 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. By that time, the mining workplace has moved and conditions 
may have changed substantially. Under the existing sampling method, it 
may be difficult for a mine operator to identify conditions of high 
dust exposure as they occur, often preventing necessary and timely 
intervention to reduce the exposures.
    CPDMs represent 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 the major benefits to be 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

[[Page 2924]]

to approve other technologically advanced sampling devices that are 
capable of monitoring dust concentrations on a real-time and continuous 
basis.
    MSHA and NIOSH have developed new procedures that would allow 
manufacturers to apply for approval of the new CPDM technology. This 
proposal would require manufacturers to demonstrate that devices using 
continuous monitoring technology are durable and can withstand the mine 
environment; can be worn by miners performing normal tasks for an 
entire work shift; provide accurate and precise measurements; and can 
be safely used in mine atmospheres where explosive mixtures of gases 
may occur.
    This proposed revision to the approval regulations is an important 
initial step to permit the introduction of the new continuous 
monitoring technology in coal mines. The use of real-time monitoring 
devices in the future would allow mine management to take immediate 
action to prevent miner overexposure and thereby reduce occupational 
lung disease.
    This proposed rule would assure that existing health benefits 
associated with the CMDPSU are maintained by updating existing 
requirements for the approval of a CMDPSU to reflect the current state 
of this technology.
    The introduction of the CPDM likely would establish some degree of 
competition in the broader market of personal monitoring technology for 
coal mining, since the CPDM is likely to evolve as a potential 
substitute for the existing CMDPSU, which is currently unique to this 
broader market and produced by a single manufacturer. Moreover, the 
proposed requirements for the approval of the CPDM, which are 
essentially performance-oriented, would provide incentives for 
continued innovation of this technology.

C. Compliance Costs

    There is only one manufacturer of the existing sampler technology, 
CMDPSU. No new applications for approval have been received in over 30 
years. The proposed revisions to the design requirements for the CMDPSU 
would 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 proposed updated 
requirements since the requirements have been integrated by policy into 
existing approvals.
    MSHA and NIOSH are aware of only one prospective manufacturer 
capable of mass producing a CPDM that could be submitted for approval 
under this proposal. 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 current pre-
commercial 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 proposed rule, there would be one manufacturer filing an 
application seeking approval of a CPDM. The cost of the proposed rule 
in the first year is estimated to be $293,000. The first year approval 
costs are annualized over an indefinite time period by using a 7 
percent discount factor that results in a cost 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 proposed 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 to file an application for approval of the CPDM (under proposed 
Sec.  74.13); and $30,000 for the cost of the CPDMs provided to NIOSH 
and MSHA by the applicant (under proposed Sec. Sec.  74.16(a) and (b)). 
Derivation of the proposed rule costs are detailed below.
    Proposed Sec. Sec.  74.7 and 74.8 would require tests that the 
applicant must have performed by a third party. These tests are for: 
Ergonomic design (under proposed Sec.  74.7(b)); environmental 
conditions (under proposed Sec.  74.7(e)); electromagnetic interference 
(under proposed Sec.  74.7(f)); flow stability and calibration of pump 
(under proposed Sec.  74.7(j)); and accuracy testing which includes 
reliability measurement, precision, and bias testing (under proposed 
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 proposed Sec. Sec.  74.7 and 74.8. The annualized cost is 
$17,500 ($250,000 x 0.07).
    Proposed Sec.  74.11 requires that the applicant submit the CPDM to 
MSHA for testing and evaluation, pursuant to 30 CFR Sec.  18.68 to 
determine whether the electronic components of the CPDM unit submitted 
for approval meet the applicable permissibility provisions. The 
following tests would 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 would be 
performed under Sec. Sec.  18.68(a)(1) and (b)(1). The methane thermal 
ignition test would be performed under Sec. Sec.  18.68(a)(1) and 
(b)(6). The maximum surface temperature test would be performed under 
Sec.  18.68(a)(1) and (b)(3). The spark ignition test would be 
performed under Sec. Sec.  18.68(a)(1), (a)(2), (a)(4), (a)(5), (b)(4), 
and (b)(5).
    The estimated time per application is 45 hours for evaluation and 
40 hours for testing. 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).
    Proposed Sec.  74.13(b) requires that a written application for 
approval be submitted to MSHA and NIOSH in duplicate. MSHA estimates 
that it would take 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 would take 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).
    Proposed Sec.  74.16(a) would require that MSHA and NIOSH each 
retain one CPDM that is submitted with the application. In addition, 
proposed Sec.  74.16(b) would require 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 would 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

[[Page 2925]]

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

    Although the CPDM is a new type of sampling device, the proposed 
rule is technologically feasible. The device has been developed and 
successfully tested in underground coal mines. This proposed rule would 
put in place the necessary requirements to enable a prospective 
manufacturer 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, which MSHA concludes is 
economically feasible for a CPDM manufacturer.

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 proposed 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 
proposed rule would not have a significant economic impact on a 
substantial number of small entities.
    The proposed rule establishes procedures and requirements for 
approving a CPDM for use in coal mines. A manufacturer of a CPDM 
receiving such an approval would thus be able to market the device to 
U.S. coal mine operators and MSHA. This U.S. market might also provide 
a commercial base for marketing the device to coal mine operators 
internationally.
    Currently, such device has not been commercialized 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. 
The proposed requirements take into account the design and performance 
of a prototype CPDM, which was developed with the financial and 
technical support of MSHA and NIOSH, in collaboration with a private 
sector monitoring technology company, as discussed under section I(A) 
of this preamble. NIOSH has carefully evaluated the design and 
performance of this prototype. This empirical basis assures the 
feasibility of the proposed requirements.
    Accordingly, since this proposed rule would foster rather than 
inhibit such commercialization, since there is not currently a CPDM 
commercialized by any entity, and since the proposed rule takes into 
account the capabilities of the single currently available prototype 
for such devices, the proposed rule should not have a significant 
economic impact on a substantial number of small entities.

VI. Paperwork Reduction Act of 1995

    The proposed rule will impose estimated information collection 
requirements of 41 burden hours which are related to filing approval 
applications required by proposed Sec.  74.13. This burden would occur 
in the first year that the rule is in effect. MSHA estimates that it 
would take 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 each of the application would need to be sent to MSHA and NIOSH. 
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) + (0.25 hrs. x $26.37 x 4 
copies). The proposed 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.The information collection 
package has been submitted to the Office of Management and Budget (OMB) 
for review under 44 U.S.C. 3504(h) of the Paperwork Reduction Act of 
1995, as amended. A copy of the information collection package can be 
obtained from the Department of Labor by e-mail request to 
<a href="/cdn-cgi/l/email-protection#87eceee9e0a9e3e6f5f5eee9c7e3e8eba9e0e8f1"><span class="__cf_email__" data-cfemail="e2898b8c85cc868390908b8ca2868d8ecc858d94">[email protected]</span></a> or by phone request at (202) 693-4129.
    MSHA requests comments to:
    <bullet> Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    <bullet> Evaluate the accuracy of the Agency's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used;
    <bullet> Enhance the quality, utility, and clarity of the 
information to be collected; and
    <bullet> Minimize the burden of the collection of information on 
those who are to respond, including through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., permitting 
electronic submission of responses.
    Comments regarding the information collection requirements should 
be sent to both OMB and MSHA. Addresses for both offices can be found 
in the ADDRESSES section of this preamble. The regulated community is 
not required to respond to any collection of information unless it 
displays a current, valid, OMB control number. MSHA displays OMB 
control numbers in 30 CFR part 3.

VII. Other Regulatory Considerations

A. The Unfunded Mandates Reform Act of 1995

    MSHA has reviewed the proposed rule under the Unfunded Mandates 
Reform Act of 1995 (2 U.S.C. 1501 et seq.). MSHA has determined that 
this proposed rule would not include any Federal mandate that may 
result in increased expenditures by State, local, or tribal 
governments; nor would 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 proposed rule would have no effect on family well-being or 
stability, marital commitment, parental rights or authority, or income 
or poverty of families and children. Accordingly, section 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

    This proposed rule would 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

    This proposed 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, this proposed rule meets the 
applicable

[[Page 2926]]

standards provided in section 3 of E.O. 12988.

E. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    This proposed rule would have no adverse impact on children. 
Accordingly, E.O. 13045 requires no further Agency action or analysis.

F. Executive Order 13132: Federalism

    This proposed rule would not have ``federalism implications'' 
because it would not ``have substantial direct effects on the States, 
on the relationship between the national government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government.'' Accordingly, E.O. 13132, requires no further 
Agency action or analysis.

G. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This proposed rule would not have ``tribal implications'' because 
it would 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. This proposed 
rule does not directly affect coal mines, only prospective 
manufacturers of CPDMs that seek to obtain the Agencies' approval for 
use of such monitoring devices in coal mines. Accordingly, MSHA has 
concluded that the proposed 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 proposed 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 proposed rule would not have a significant economic 
impact on a substantial number of small entities.

List of Subjects in 30 CFR Part 74

    Mine safety and health, Incorporation by reference, Occupational 
safety and health, Direct reading devices, Monitoring technology.

    Dated: January 8, 2009.
Richard E. Stickler,
Acting Assistant Secretary for Mine Safety and Health.

    For the reasons set out in the preamble, and under the authority of 
the Federal Mine Safety and Health Act of 1977 as amended by the Mine 
Improvement and New Emergency Response Act of 2006, MSHA proposes to 
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 PERSONAL MONITORS

Subpart A--Introduction
Sec.
74.1 Purpose.
74.2 Definitions.
Subpart B--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 CPDM.
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--Introduction


Sec.  74.1  Purpose.

    The regulations in this part set forth the requirements for 
approval of coal mine dust measurement units designed to determine 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 monitor 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 
monitor 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 monitor 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 personal 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 monitor to replicate measurement results.

Subpart B--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:

[[Page 2927]]

    (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 <plus-minus>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 
<plus-minus>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 <plus-
minus>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 (i) 
displaying the actual pump run time in minutes (up to 999 minutes) and 
(ii) retaining the last reading after the pump is shut down due to 
either a flow restriction described in paragraph (a)(14) or low battery 
power described in paragraph (a)(16) 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 Door-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 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 <plus-minus> 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 the intentional or inadvertent alteration of 
the dust deposited on the filter. The cassette must be easily removable 
without causing a loss or gain of capsule weight. Covers enclosing the 
capsule 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 and 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.

[[Page 2928]]

    (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 this 30 CFR 
part 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 or tests 
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 resulting total added weight carried by the miner by 
such combination 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 the range from 10% to 2 times the PEL for respirable coal mine 
dust. For end-of-shift average concentrations exceeding 2 times the 
PEL, the CPDM shall, at minimum, provide a reliable indication that the 
concentration exceeded 2 times the PEL.
    (e) Environmental conditions. The CPDM shall operate reliably and 
measure respirable coal mine dust concentrations 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 the control of and protection from electromagnetic 
interference.
    (1) Emissions: ANSI C95.1-1982 (Standard for Safety Levels with 
Respect to Human Exposure to Radio Frequency Electromagnetic Fields) 
and 47 CFR part 15 (FCC Radio Frequency Devices). Persons must proceed 
in accordance with ANSI C95.1-1982. 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.
    Persons may inspect a copy at MSHA, Office of Standards, 
Regulations, and Variances, 1100 Wilson Boulevard, Room 2350, 
Arlington, Virginia 22209-3939 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) Immunity/Susceptibility: IEC 61000-4 and -6 (Electromagnetic 
compatibility--Part 4-6: Testing and measurement techniques--Immunity 
to conducted disturbances, induced by radio-frequency fields). Persons 
must proceed in accordance with IEC 61000-4 and 6. 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 Electrotechnical Commission at the address provided 
below. International Electrotechnical Commission, IEC Central Office, 
3, rue de Varemb[eacute], P.O.

[[Page 2929]]

Box 131, CH-1211 GENEVA 20, Switzerland, http://www.standardsinfo.net.
    Persons may inspect a copy at MSHA, Office of Standards, 
Regulations, and Variances, 1100 Wilson Boulevard, Room 2350, 
Arlington, Virginia 22209-3939 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 part, after 
undergoing the following durability tests, which NIOSH will apply to 
test units prior to their use in further testing under Sec.  74.8 of 
this subpart:

----------------------------------------------------------------------------------------------------------------
                                                                                          1 Hours/axis, 3 axis;
                                                                 US Highway vibration,   total duration = 3 hrs,
              Vibration                  Mil-Std-810F, 514.5       restrained figure       equivalent to 1,000
                                                                        514.5C-1                  miles
----------------------------------------------------------------------------------------------------------------
Drop.................................  3-foot drop onto bare    In standard in-use       1 drop per axis (3
                                        concrete surface.        configuration.           total).
----------------------------------------------------------------------------------------------------------------

    Persons must proceed in accordance with Mil-Std-810F, 514.5. 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/.
    Persons may inspect a copy at MSHA, Office of Standards, 
Regulations, and Variances, 1100 Wilson Boulevard, Room 2350, 
Arlington, Virginia 22209-3939 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 
and/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<SUP>3</SUP>).
    (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 4.0 mg/m<SUP>3</SUP>. 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 <plus-minus>5 percent from the calibrated 
flow for 95 percent of samples taken of 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 unit is 
adequately charged to 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 approvals for such other devices, as might be 
required under federal regulations, prior to receiving final 
certification of the CPDM under this part.
    (2) A CPDM that is integrated with another device shall be tested, 
pursuant 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 provides an 
indication 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 <plus-minus>25 
percent of the true respirable dust concentration, as determined by 
CMDPSU reference measurements, over a concentration range of 10% to 2 
times the PEL; and
    (2) For intra-shift measurements of less than 8 hours, a 95 percent 
confidence that the recorded measurements are within <plus-minus> 25 
percent of the true respirable dust concentration, as determined by 
CMDPSU reference measurements, over the concentration range equating to 
10% to 2 times the PEL for an 8-hour period.\1\
---------------------------------------------------------------------------

    \1\ The equivalent dust concentration range to the 8-hour range 
of 10% to 2 times the PEL (currently 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/m3; 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/m3; for a 4-hours 
measurement, the equivalent range would be: 0.4 - 8 mg/m3; * * * 
etc. A CPDM must perform accurately, as specified, for intrashift 
measurements within such equivalent concentration ranges.
---------------------------------------------------------------------------

    (c) Reliability of measurements. The CPDM shall meet the accuracy 
requirements under paragraph (b) of this section, regardless of the 
variation in density, composition, or size distribution of respirable 
coal mine dust particles, or the presence of spray mist.
    (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

[[Page 2930]]

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 equating to 10% 
to 2 times the PEL 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, between 10% and 2 times 
the PEL 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 
Testing Procedures'' available at: http://www.cdc.gov/niosh/mining. All 
testing results shall be submitted to NIOSH in writing on the 
application filed under Sec.  74.13.


Sec.  74.9  Quality assurance.

    (a) General requirements. The applicant shall be responsible for 
the establishment and maintenance of a quality control system that 
assures that 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. To establish and to maintain an approval under this part, 
the applicant shall:
    Submit a copy of the most recent registration under ISO Q9001-2000, 
or under any updated version of this quality management standard 
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.
    Persons must proceed in accordance with Q9001-2000. 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 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.
    Persons may inspect a copy at MSHA, Office of Standards, 
Regulations, and Variances, 1100 Wilson Boulevard, Room 2350, 
Arlington, Virginia 22209-3939 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 reasonable time as 
determined by NIOSH. Failure to correct a deficiency may result in 
NIOSH disapproving the pending application or, in the case of an 
approved device, revoking the approval of the device, until such time 
as NIOSH has determined that the deficiency is remedied.


Sec.  74.10  Operating and maintenance instructions.

    (a) Contents. The manufacturer must include operating instructions 
and a maintenance and service life plan with each new CPDM unit sold. 
These documents must be clearly written.
    (1) Operating and storage instructions must address the following 
topics and elements:
    (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) Procedures for calibration of the CPDM;
    (v) Procedures for inspecting the operating condition of the CPDM;
    (vi) Procedures and conditions for storage, including the 
identification of any storage conditions that would likely impair the 
effective functioning of the CPDM; and
    (vii) 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 completely address 
the following topics:
    (i) Any conditions that should govern the removal from service of 
the CPDM; and
    (ii) Any procedures by which a user or others should inspect the 
CPDM, perform any maintenance and calibration procedures, and determine 
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 for approval with the application for approval of the device and 
resubmitted to NIOSH if substantive changes are made to the approved 
unit 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 the 
conduct of testing to verify that protocols are adequate to address the 
requirements.
    (c) Reporting of applicant testing results. The applicant shall 
arrange for the protocols and results from testing specified under 
paragraph (a) of this section to be reported by the independent testing 
entity directly to NIOSH when submitting the application under Sec.  
74.13 of this part.
    (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

[[Page 2931]]

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. The Freedom of Information 
Act governs disclosure of applicant materials requested by the public.


Sec.  74.13  Applications.

    (a) Testing of a CMDPSU will be undertaken by NIOSH, and testing of 
the pump unit of such a sampler unit will be undertaken by MSHA, only 
pursuant to a written application in duplicate. 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 sent to MSHA.
    (b) Testing of a CPDM will be undertaken by the applicant as 
specified under Sec.  74.11 and by MSHA only pursuant to a written 
application in duplicate. 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 directly to NIOSH by the independent testing entity, as 
specified under Sec.  74.11. Three complete CPDM units must be sent to 
NIOSH with the application, and one CPDM unit must be sent to MSHA.
    (c) Complete drawings and specifications shall be adequate in 
number and 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 
thereof, 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, as 
the case may require. NIOSH shall 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. No informal notification of 
approval will be issued. 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 thereof, 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 thereof, 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 certification.


Sec.  74.15  Approval labels.

    (a) Certificates 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 unit.
    (d) Use of the approval labels obligates the applicant to whom the 
certificates of approval were 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 
certificates of approval were based. Use of the approval labels is 
authorized only on CMDPSUs or CPDMs, as appropriate, that conform 
strictly to the drawings and specifications upon which the certificates 
of approval were based.


Sec.  74.16  Material required for record.

    (a) As part of the permanent record of the investigation, 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 unit 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, as in the case of an 
original application.
    (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 the regulations in this 
part may be revoked for cause by NIOSH or MSHA which issued the 
certificate.

 [FR Doc. E9-534 Filed 1-15-09; 8:45 am]
BILLING CODE 4510-43-P


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