Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Proposed Rules 2915 

0.96, we amend 28 CFR part 548 as 

follows. 

Subchapter C—Institutional Management 

PART 548—RELIGIOUS PROGRAMS 

1. The authority citation for 28 CFR 

part 548 continues to read as follows: 

Authority: 5 U.S.C. 301; 18 U.S.C. 3621, 

3622, 3624, 4001, 4042, 4081, 4082 (Repealed 

in part as to offenses committed on or after 

November 1, 1987), 5006–5024 (Repealed 

October 12, 1984 as to offenses committed 

after that date), 5039; 28 U.S.C. 509, 510; 42 

U.S.C. 1996; 28 CFR 0.95–0.99. 

2. Add a new § 548.21 to read as 

follows: 

§ 548.21 Chapel library materials. 

(a) The Bureau maintains chapel 

library materials for inmates to pursue 

religious beliefs and practices while in 

Bureau custody consistent with 

ensuring that such materials do not 

jeopardize the safety, security, or 

orderly operation of Bureau facilities, or 

protection of the public. 

(b) Material may be excluded from the 

chapel library if it is determined that 

such material could incite, promote, or 

otherwise suggest the commission of 

violence or criminal activity. 

(c) For purposes of this subpart, 

inciting, promoting, or otherwise 

suggesting the commission of violence 

or criminal activity may include, but is 

not limited to: 

(1) Advocating or fostering violence, 

vengeance, or hatred toward particular 

religious, racial, or ethnic groups; or 

(2) Urging the overthrow or 

destruction of the United States. 

[FR Doc. E9–550 Filed 1–15–09; 8:45 am] 

BILLING CODE 4410–05–P 

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. 

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: zzMSHAComments@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 zzMSHAComments@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 (email), (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 


hsrobinson on PROD1PC76 with PROPOSALS
2916 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Proposed Rules 

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). 

2For 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. 

3Reference 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. 

4See: 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. 

5MSHA’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. 

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

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®). 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®

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

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

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. 

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 


hsrobinson on PROD1PC76 with PROPOSALS
Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Proposed Rules 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 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 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 directreading 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 § 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 § 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 § 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 § 74.3 would renumber 

existing § 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 § 74.4 would renumber 

existing § 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 


hsrobinson on PROD1PC76 with PROPOSALS
2918 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Proposed Rules 

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 


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Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Proposed Rules 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 § 74.5 renumbers existing 

§ 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 § 74.6 is derived from 

existing § 74.6(d) regarding applications. 

The proposal makes only clarifying 

changes by referencing proposed § 74.13 

(filing applications). 

Subpart C—Requirements for 

Continuous Personal Dust Monitors 

(CPDMs) 

G. Section 74.7 Design and 

Construction Requirements 

Proposed § 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 § 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 endof-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 


hsrobinson on PROD1PC76 with PROPOSALS
2920 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Proposed Rules 

6NIOSH Manual of Analytic Methods, Method 

0600, Issue 3, Fourth Edition, January 15, 1998. 

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. 

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 § 74.8 and intrinsic safety testing 

by MSHA under § 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. 

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 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 

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 § 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

Proposed paragraph (a) would require 

that the CPDM be capable of measuring 


hsrobinson on PROD1PC76 with PROPOSALS
Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Proposed Rules 2921 

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). 

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. 

11NIOSH 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. 

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. 

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. 

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

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, 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. 

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 § 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. 

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 


hsrobinson on PROD1PC76 with PROPOSALS
2922 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Proposed Rules 

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 § 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 §§ 74.7–74.8 of this part, 

with the exception of durability testing 

under § 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 § 74.12, concerning the 

conduct of tests, renumbers existing 

§ 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 § 74.13 would renumber 

existing § 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 

§ 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 § 74.14 renumbers existing 

§ 74.7 and would specify procedures by 

which NIOSH and MSHA would 

approve or disapprove an application 

for either a CMDPSU or CPDM. 

Proposed § 74.14 is unchanged from the 

existing provision, except to expand the 

scope to include the CPDM. 

O. Section 74.15 Approval Labels 

Proposed § 74.15 renumbers existing 

§ 74.8 and would specify labeling 

procedures, requirements, and related 

obligations of the applicant. Proposed 

§ 74.15 is unchanged from the existing 

provision, except to expand the scope to 

include the CPDM. 


hsrobinson on PROD1PC76 with PROPOSALS
Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Proposed Rules 2923 

13U.S. DOL Employment Standards 

Administration, Office of Workers’ Compensation 

Programs, Annual Report to Congress FY 2005, 

Submitted to Congress 2008. 

P. Section 74.16 Material Required for 

Record 

Proposed § 74.16 renumbers existing 

§ 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 § 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 § 74.17 renumbers § 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 § 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 § 74.18 renumbers § 74.11 

and would authorize NIOSH or MSHA 

to revoke for cause any certification of 

approval for a CMDPSU or CPDM. 

Proposed § 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

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 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 


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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 precommercial 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 

× 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 

§§ 74.7 and 74.8); $9,500 for MSHA to 

evaluate and test the CPDM for intrinsic 

safety (under proposed § 74.11); $3,200 

to file an application for approval of the 

CPDM (under proposed § 74.13); and 

$30,000 for the cost of the CPDMs 

provided to NIOSH and MSHA by the 

applicant (under proposed §§ 74.16(a) 

and (b)). Derivation of the proposed rule 

costs are detailed below. 

Proposed §§ 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 § 74.7(b)); environmental 

conditions (under proposed § 74.7(e)); 

electromagnetic interference (under 

proposed § 74.7(f)); flow stability and 

calibration of pump (under proposed 

§ 74.7(j)); and accuracy testing which 

includes reliability measurement, 

precision, and bias testing (under 

proposed §§ 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 §§ 74.7 and 74.8. The 

annualized cost is $17,500 ($250,000 × 

0.07). 

Proposed § 74.11 requires that the 

applicant submit the CPDM to MSHA 

for testing and evaluation, pursuant to 

30 CFR § 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 § 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 

§§ 18.68(a)(1) and (b)(1). The methane 

thermal ignition test would be 

performed under §§ 18.68(a)(1) and 

(b)(6). The maximum surface 

temperature test would be performed 

under § 18.68(a)(1) and (b)(3). The spark 

ignition test would be performed under 

§§ 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. × $84 × 1.617) + (40 hrs. 

× $84)]. The annualized cost is 

approximately $700 ($9,500 × 0.07). 

Proposed § 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 × 40 

hrs. x $74.32 per hr.) + (0.25 hrs. × 

$26.37 per hour × 4 copies) + (250 pages 

x $0.15 cost per page × 4 copies) + ($5 

× 4 copies)]. The annualized cost is 

approximately $200 ($3,200 × 0.07). 

Proposed § 74.16(a) would require 

that MSHA and NIOSH each retain one 

CPDM that is submitted with the 

application. In addition, proposed 

§ 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 


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approval of the application is estimated 

to be $30,000 (3 CPDMs × $10,000 per 

CPDM). The annualized cost is $2,100 

($30,000 × 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 

§ 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 × 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. × $74.32) 

+ (0.25 hrs. × $26.37 × 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 


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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 

§ 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. 

§ 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 

§ 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. 

§ 74.4 Specifications of sampler unit. 

(a) Pump unit: 


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(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 preweighed 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 cyclonecassette 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. 


hsrobinson on PROD1PC76 with PROPOSALS
2928 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Proposed Rules 

(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. 

§ 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 § 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. 

§ 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 § 74.13 of this part. 

Subpart C—Requirements for 

Continuous Personal Dust Monitors 

§ 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 § 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 § 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 § 74.8, for an end-ofshift 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 § 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 Varembe ́, P.O. 


hsrobinson on PROD1PC76 with PROPOSALS
Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Proposed Rules 2929 

1The equivalent dust concentration range to the 

8-hour range of 10% to 2 times the PEL (currently 

0.2 ¥ 4 mg/m3) 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 × (0.2 ¥ 4 mg/m3) = 1.6 

¥ 32 mg/m3; for a two-hour measurement, the 

applicable concentration range would be calculated 

as: 8 hours/2 hours × (0.2 ¥ 4 mg/m3) = 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. 

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 § 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 § 74.8 of this subpart: 

Vibration Mil-Std-810F, 514.5 US Highway vibration, restrained figure 

514.5C–1 

1 Hours/axis, 3 axis; total duration = 

3 hrs, equivalent to 1,000 miles 

Drop ....................... 3-foot drop onto bare concrete surface In standard in-use configuration ........... 1 drop per axis (3 total). 

Persons must proceed in accordance 

with Mil-Std-810F, 514.5. The Director 

of the Federal Register approves this 

incorporation by reference in 

accordance with 5 U.S.C. 552(a) and 1 

CFR part 51. Persons may obtain a copy 

from the U.S. Department of Defense at 

the address provided below. ASC/ENOI, 

Bldg. 560, 2530 Loop Road West, 

Wright-Patterson AFB OH 45433–7101, 

http://www.dtc.army.mil/navigator/. 

Persons may inspect a copy at MSHA, 

Office of Standards, Regulations, and 

Variances, 1100 Wilson Boulevard, 

Room 2350, Arlington, Virginia 22209– 

3939 or at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, 

or go to: http://www.archives.gov/ 

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

(h) Reporting of monitoring results. 

(1) The CPDM shall report continuous 

monitoring results legibly and/or 

audibly during use. A digital display, if 

used, shall be illuminated and shall 

provide a minimum character height of 

6 millimeters. Other forms of display 

(e.g., analogue) must provide 

comparable visibility. Auditory 

reporting, if used, shall be clear, have 

adjustable volume, and provide means 

for the user to obtain data reports 

repetitively. The CPDM shall also report 

end-of-shift results using computer 

software compatible with current, 

commonly used personal computer 

technology. 

(2) The CPDM shall report results as 

cumulative mass concentration in units 

of mass per volume of air (mg/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. 

§ 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

(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 


hsrobinson on PROD1PC76 with PROPOSALS
2930 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Proposed Rules 

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 § 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 § 74.13. 

§ 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 § 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. 

§ 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. 

§ 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 §§ 74.7– 

74.8 of this part, with the exception of 

durability testing, which shall be 

conducted by NIOSH as specified in 

§ 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 §§ 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 § 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 

§ 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 


hsrobinson on PROD1PC76 with PROPOSALS
Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Proposed Rules 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. 

§ 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 § 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 § 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. 

§ 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. 

§ 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 fullscale 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. 

§ 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. 

§ 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 § 74.11(d). 

§ 74.18 Withdrawal of certification. 

Any certificate of approval issued 

under the regulations in this part may 

be revoked for cause by NIOSH or 

MSHA which issued the certificate. 

[FR Doc. E9–534 Filed 1–15–09; 8:45 am] 

BILLING CODE 4510–43–P 


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