Coal Mine Dust Personal Monitors, 2915-2931 [E9-534]

Agencies

• DEPARTMENT OF LABOR
• Mine Safety and Health Adminisration
• Mine Safety and Health Administration

[Federal Register Volume 74, Number 11 (Friday, January 16, 2009)]
[Proposed Rules]
[Pages 2915-2931]
From the Federal Register Online via the Government Printing 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: https://www.regulations.gov. Follow 
the instructions for submitting comments.
    (2) Electronic mail: zzMSHA-Comments@dol.gov. 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 https://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 https://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 zzMSHA-Comments@dol.gov, 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 
silvey.patricia@dol.gov (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 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 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/m3 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/
m3). 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/m3 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 
 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/
m3, 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 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/m3 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/
m3 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 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: https://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\
----------------------------------------