Federal Register: January 16, 2009 (Volume 74, Number 11)
DOCID: fr16ja09-43 FR Doc E9-534
DEPARTMENT OF LABOR
Mine Safety and Health Administration
CFR Citation: 30 CFR Part 74
RIN ID: RIN 1219-AB61
NOTICE: PROPOSED RULES
DOCID: fr16ja09-43
DOCUMENT ACTION: Proposed rule and close of comment period.
SUBJECT CATEGORY:
Coal Mine Dust Personal Monitors
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.
DOCUMENT 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.
SUMMARY:
Coal Mine Dust Personal Monitors,
SUPPLEMENTAL 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. SectionbySection 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
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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 74Coal 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\
\1\ In 1978, responsibility for mine safety and health was
transferred from the Department of Interior to the Department of
Labor. In 1980 the Department of Health Education and Welfare became the Department of Health and Human Services (HHS).
Since 1970, coal mine operators and MSHA have used approved coal mine dust personal sampler units (CMDPSUs) to determine the concentration of respirable dust in coal mine atmospheres. These devices sample the mine atmosphere by drawing mine air through a filter cassette that collects respirable coal mine dust. At the end of a full shift or 8 hours, whichever time is less, the cassette is sent to MSHA for processing. Each cassette is 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 endofshift 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 fullshift exposures exceeding regulatory limits.\2\
\2\ For a more complete description of the technology, see:
Volkwein, J.C., Vinson, R.P., S.J. Page, L.J. McWilliams, G.J. Joy,
S.E. Mischler, and D.P. Tuchman. Laboratory and field performance of
a continuously measuring personal respirable dust monitor. CDC RI
9669. September 2006. 47 pp. and Volkwein, J.C., R.P. Vinson, L.J.
McWilliams, D.P. Tuchman, and S.E. Mischler, Performance of a New
Personal Respirable Dust Monitor for Mine Use. CDC RI 9663. June 2004.
In 2006, NIOSH, in collaboration with MSHA and stakeholders
representing the mining industry and labor, completed extensive testing
to evaluate the accuracy of the precommercial 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
endofshift measurements within
\3\ Reference measurements were established using multiple
gravimetric samplers in dust exposure chambers for laboratory
testing and using CMDPSUs in a variety of coal mines for field testing.
\4\ See: Volkwein, J.C., R.P. Vinson, S.J. Page, L.J.
McWilliams, G.J. Joy, S.E. Mischler, and D.P. Tuchman. Laboratory
and field performance of a continuously measuring personal
respirable dust monitor. CDC RI 9669. September 2006. 47 pp. and
Volkwein, J.C., R.P. Vinson, L.J. McWilliams, D.P. Tuchman, and S.E.
Mischler. Performance of a New Personal Respirable Dust Monitor for Mine Use. CDC RI 9663. June 2004.
B. 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 designspecific 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.
\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.
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 endofshift 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 endofshift 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 performancebased and other requirements by which MSHA and NIOSH would approve CPDM devices for use in coal mines. The performancebased 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 mid1990s. 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 performancebased 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 performancebased and other requirements for approval of the new CPDMs. The requirements would facilitate innovation among directreading device manufacturers for the continued improvement of this technology.
The proposal also updates the existing designbased 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 AIntroductionPurpose and definitions.
Subpart BRequirements for Coal Mine Dust Personal Sampler Unit specifications for existing technology.
Subpart CRequirements for Continuous Personal Dust Monitors specifications for new technology.
Subpart DGeneral Requirements for All Devicesadministrative provisions applicable to both the CMDPSU and CPDM.
III. SectionbySection Analysis
The sectionbysection 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 AIntroduction 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 standardssetting 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 tightfitting.
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
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 10hour period, versus an 8hour 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
cyclonecassette 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 CRequirements 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. Designspecific 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 2kg 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 endofshift 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 standardssetting 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 3foot 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 endofshift 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
\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 12hour shift, since the noncompliant 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 nonCPDM 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 nonCPDM 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 DirectReading Monitors for
Gases and Vapors).\7\ The proposed requirements also reflect the state
oftheart technology of the CPDM prototype. Accordingly, this proposed
rulemaking establishes a sciencebased, 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 peerreviewed journal articles.\8\
\7\ Kennedy, E. R., T.J. Fischbach, R. Song, P.M. Eller, and
S.A. Shulman, 1995. Guidelines for air sampling and analytical
method development and evaluation, DHHS (NIOSH) Publication No. 95 117.
\8\ Volkwein, J.C., R.P. Vinson, S.J. Page, L.J. McWilliams,
G.J. Joy, S.E. Mischler and D.P. Tuchman. Laboratory and field
performance of a continuously measuring personal respirable dust
monitor. CDC RI 9669. September 2006. 47 pp. and Volkwein, J.C.,
R.P. Vinson, L.J. McWilliams, D.P. Tuchman, and S.E. Mischler.
Performance of a New Personal Respirable Dust Monitor for Mine Use. CDC RI 9663. June 2004.
Proposed paragraph (a) would require that the CPDM be capable of measuring
[[Page 2921]]
respirable dust within the personal breathing zone of the miner whose
exposure is being monitored. The breathing zone is generally considered
to be the area surrounding the worker's nose and mouth. This zone is
pictured by drawing a sphere with a 10inch 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,
62:416427, 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 fullshift measurements
of 8 hours or more, a 95 percent confidence that the recorded
measurements are within
\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
precommercial 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, fullshift 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 intrashift measurements of less than 8 hours, proposed
paragraph (b)(2) would require a 95 percent confidence that the
recorded measurements are within
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 8hour 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 Q90012000 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 systemsRequirements, 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 Q90012000 to NIOSH, together with the application and, subsequent to
[[Page 2922]]
an approval, upon request. Registration under any updated version of
ISO Q90012000 would be considered evidence of compliance with the ISO
Q90012000 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 qualityrelated 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. 74.774.8 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 inhouse 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 DGeneral 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. Longterm exposure to excessive levels of respirable coal mine dust causes coal workers' pneumoconiosis (CWP), commonly known as ``black lung.'' Overexposure to respirable silica dust can lead to silicosis. These occupational lung diseases can devastate a miner's quality of life, create a heavy burden on the victim and the victim's family, and in some cases lead to premature death. While significant progress has been made over the years in reducing respirable dust levels, coal miners continue to be at risk of developing CWP and silicosis, including progressive massive fibrosis (PMF), the most disabling and potentially fatal form of CWP. While there is no cure for these disabling lung diseases, they are entirely preventable.
According to the U.S. Department of Labor's (DOL) Office of
Workers' Compensation Programs, which administers the Black Lung
benefits program to compensate victims of dust exposure in mines and
certain eligible survivors of deceased miners, black lung benefits
(monthly wage replacement and medical benefits) totaled $676 million in FY 2005.\13\
\13\ U.S. DOL Employment Standards Administration, Office of
Workers' Compensation Programs, Annual Report to Congress FY 2005, Submitted to Congress 2008.
Under the Federal Coal Mine Health and Safety Act of 1969 (Pub. L. 91173), the predecessor to the Federal Mine Safety and Health Act of 1977 (Pub. L. 95164), 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 personwearable batterypowered 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 realtime 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
realtime 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 realtime 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 realtime 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 performanceoriented, 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.
FOR FURTHER INFORMATION CONTACT
Patricia W. Silvey, Director, Office of Standards, Regulations, and Variances, MSHA, at
silvey.patricia@dol.gov (email), (202) 6939440 (voice), or (202) 693
9441 (facsimile).