[Federal Register: January 16, 2009 (Volume 74, Number 11)]
[Proposed Rules]
[Page 2915-2931]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ja09-43]
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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: 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 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 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.
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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: 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\
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\13\ U.S. DOL Employment Standards Administration, Office of
Workers' Compensation Programs, Annual Report to Congress FY 2005,
Submitted to Congress 2008.
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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
king.darrin@dol.gov or by phone request at (202) 693-4129.
MSHA requests comments to:
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;
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;
Enhance the quality, utility, and clarity of the
information to be collected; and
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 5 percent of that collected with a sampling
head assembly operated with nonpulsating flow.
(9) Belt clips. The pump unit shall be provided with a belt clip
which will hold the pump securely on a coal miner's belt.
(10) Recharging connection. A suitable connection shall be provided
so that the battery may be recharged without removing the battery from
the pump case or from the battery case if a separate battery case is
used.
(11) Flow rate indicator. A visual indicator of flow rate shall be
provided either as an integral part of the pump unit or of the sampling
head assembly. The flow rate indicator shall be calibrated within
5 percent at 2.2, 2.0, and 1.7 liters per minute to
indicate the rate of air passing through the accompanying sampling head
assembly.
(12) Flow rate range. The pump shall be capable of operating within
a range of from 1.5 to 2.5 liters per minute and shall be adjustable
over this range.
(13) Flow rate consistency. The flow shall remain within 0.1 liters per minute over at least a 10-hour period when the
pump is operated at 2 liters per minute with a standard sampling head
assembly.
(14) Flow restriction indicator. The pump shall be capable of
detecting restricted flow and providing a visual indication if it
occurs. The flow restriction indicator shall remain activated until the
cause is corrected. The pump shall shut down automatically if flow is
restricted for one minute.
(15) Duration of operation. The pump with a fully charged battery
pack shall be capable of operating for (i) not less than 8 hours at a
flow rate of 2 liters per minute against a resistance of 25 inches (64
centimeters) of water measured at the inlet of the pump; and (ii) for
not less than 10 hours at a flow rate of 2 liters per minute against a
resistance of 15 inches (38 centimeters) of water measured at the inlet
of the pump.
(16) Low battery indicator. The pump unit shall be equipped with a
visual indicator of low battery power.
(17) Elapsed time indicator. The pump unit shall be capable of (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 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:
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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
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Drop................................. 3-foot drop onto bare In standard in-use 1 drop per axis (3
concrete surface. configuration. total).
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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/m3).
(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/m3. If the CPDM uses a rechargeable battery, the
battery charger shall be operated from a 110 (VAC) (nominal), 60 Hz
power line.
(j) Flow stability and calibration of pump. If a pump is used, the
flow shall not vary more than 5 percent 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 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 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\
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\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