1360 Federal Register / Vol. 77, No. 5 / Monday, January 9, 2012 / Proposed Rules 

1Petsonk EL, Parker JE [2008]. Coal workers’ lung 

diseases and silicosis. In: Fishman AP, Elias J, 

Fishman J, Grippi M, Senior R, Pack A eds. 

Fishman’s Pulmonary Diseases and Disorders. 4th 

ed. New York: McGraw-Hill, pp. 967–980. 

2The Mine Safety and Health Administration 

(MSHA) has recently published a notice of 

proposed rulemaking that seeks to lower the 

existing exposure limit from 2.0 mg/m3 to 1.0 mg/ 

m3 (75 FR 64412, October 19, 2010). 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 37 

[Docket No. CDC–2011–0013; NIOSH–225] 

RIN 0920–AA21 

Specifications for Medical 

Examinations of Underground Coal 

Miners 

AGENCY: Centers for Disease Control and 

Prevention, HHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: With this notice of proposed 

rulemaking, the Department of Health 

and Human Services (HHS) proposes to 

modify its regulations on Specifications 

for Medical Examinations of 

Underground Coal Miners. Existing 

regulations establish specifications for 

providing, interpreting, classifying, and 

submitting film-based roentgenograms 

(now commonly called chest 

radiographs or X-rays) of underground 

coal miners for the surveillance of coal 

workers’ pneumoconiosis (black lung) 

under the Coal Workers’ Health 

Surveillance Program, administered by 

the National Institute for Occupational 

Safety and Health (NIOSH). The current 

standards specify requirements that 

permit the use of film-based 

radiography systems only; proposed 

amendments would retain those 

standards (with minor modifications 

that reflect more commonly-used terms) 

and add a parallel set of standards to 

specify requirements that would permit 

the use of digital radiography systems. 

An additional proposed amendment 

would require coal mine operators to 

provide NIOSH with employee rosters 

to assist the Program in improving 

participation by miners. 

DATES: Comments must be received by 

March 9, 2012. 

ADDRESSES: You may submit comments, 

identified by ‘‘RIN 0920–AA21,’’ by any 

of the following methods: 

• Internet: Access the Federal erulemaking portal at http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Email: NIOSH Docket Officer, 

nioshdocket@cdc.gov. Include ‘‘RIN 

0920–AA21’’ and ‘‘42 CFR 37’’ in the 

subject line of the message. 

• Mail: NIOSH Docket Office, Robert 

A. Taft Laboratories, MS–C34, 4676 

Columbia Parkway, Cincinnati, OH 

45226. 

Instructions: All submissions received 

must include the agency name and 

docket number or Regulation Identifier 

Number (RIN) for this rulemaking. All 

relevant comments will be posted 

without change to http:// 

www.regulations.gov including any 

personal information provided. For 

detailed instructions on submitting 

comments and additional information 

on the rulemaking process, see the 

‘‘Public Participation’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov or http:// 

www.cdc.gov/niosh/docket/ 

NIOSHdocket0225.html. 

FOR FURTHER INFORMATION CONTACT: 

Anita Wolfe, Public Health Analyst, 

Division of Respiratory Disease Studies, 

National Institute for Occupational 

Safety and Health, 1095 Willowdale 

Road, MS B208, Morgantown, WV, 

26505, Telephone (888) 480–4042 (this 

is a toll-free number). Information 

requests can also be submitted by email 

to cwhsp@cdc.gov. 

SUPPLEMENTARY INFORMATION: The 

preamble to this notice of proposed 

rulemaking is organized as follows: 

Table of Contents 

I. Public Participation 

II. Background 

A. Need for Rulemaking 

B. Scope of Rulemaking 

C. Impact of Rulemaking 

III. Summary of Proposed Rule 

A. Subpart—Chest Radiographic 

Examinations 

B. Subpart—Autopsies 

IV. Regulatory Assessment Requirements 

A. Executive Order 12866 

B. Regulatory Flexibility Act 

C. Paperwork Reduction Act 

D. Small Business Regulatory Enforcement 

Fairness Act 

E. Unfunded Mandates Reform Act of 1995 

F. Executive Order 12988 (Civil Justice) 

G. Executive Order 13132 (Federalism) 

H. Executive Order 13045 (Protection of 

Children From Environmental Health 

Risks and Safety Risks) 

I. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

J. Plain Writing Act of 2010 

V. Proposed Rule 

I. Public Participation 

Interested persons or organizations 

are invited to participate in this 

rulemaking by submitting written views, 

arguments, recommendations, and data. 

Comments are invited on any topic 

related to this proposal. In addition, 

HHS invites comments specifically on 

the following questions related to this 

rulemaking: 

(1) Does the current scientific 

evidence support the assertion that the 

application of digital chest imaging can 

be equivalent to film-screen 

radiography, if appropriate equipment, 

procedures, and methods are applied, in 

meeting the objectives of the Coal 

Workers’ Health Surveillance Program 

mandated by 30 U.S.C. 843? 

(2) Is there evidence that the proposed 

specifications for equipment, personnel, 

procedures, and methods will not be 

adequate to assure that the application 

of digital chest imaging will be 

equivalent to film-screen radiography in 

meeting the objectives of the Coal 

Workers’ Health Surveillance Program? 

What specific changes are needed to 

ensure equivalence and what is the 

evidence supporting those changes? 

(3) Is there evidence that any element 

of the specifications will not be feasible 

(for technological or financial reasons) 

for a significant proportion of the digital 

radiology facilities in coal mining 

regions? If yes, what changes in the 

specifications for equipment, personnel, 

procedures, and/or methods can 

improve feasibility while continuing to 

ensure the equivalence of digital chest 

imaging to film-based chest imaging for 

accurately detecting occurrence and 

progression of coal workers’ 

pneumoconiosis (CWP) among coal 

miners? 

II. Background 

All mining work generates fine 

particles of dust in the air. Coal miners 

who inhale excessive dust are known to 

develop a group of diseases of the lungs 

and airways, including chronic 

bronchitis, emphysema, chronic 

obstructive pulmonary disease, silicosis, 

and CWP.1 To address such threats to 

the U.S. coal mining workforce, the Coal 

Mine Health and Safety Act was enacted 

in 1969 (Pub. L. 91–173) and amended 

by the Federal Mine Safety and Health 

Act of 1977 (Pub. L. 95–164, 30 U.S.C. 

801 et seq.) (Mine Act). The statutes 

included an enforceable 2 milligrams 

per cubic meter limit on respirable dust 

exposure during underground coal mine 

work (30 U.S.C. 842(b)(2)).2 The science 

available at that time indicated that 

enforcement of this limit would greatly 

reduce the development of CWP, but 

could not ensure that all miners would 

be protected from developing disabling 

or lethal disease. 

The NIOSH Coal Workers’ Health 

Surveillance Program (CWHSP), also 


tkelley on DSK3SPTVN1PROD with PROPOSALS4
Federal Register / Vol. 77, No. 5 / Monday, January 9, 2012 / Proposed Rules 1361 

3 International Labour Office [2011]. Guidelines 

for the use of ILO International Classification of 

Pneumoconiosis, revised edition 2011. Geneva, 

Switzerland: International Labour Office. 

Occupational Safety and Health Series No. 22 (Rev. 

2011). 

4NIOSH [2007]. Roentgenographic Interpretation 

Form [http://www.cdc.gov/niosh/topics/ 

surveillance/ords/pdfs/CWHSP-ReadingForm2.8.pdf]. Date accessed: January 5, 2011. 

5NIOSH [1995]. Criteria for a recommended 

standard: Occupational exposure to respirable coal 

mine dust. Cincinnati, Ohio: U.S. Department of 

Health and Human Services, Centers for Disease 

Control and Prevention, National Institute for 

Occupational Safety and Health, DHHS (NIOSH) 

Publication No. 95–106. 

See also NIOSH [2010]. A review of information 

published since 1995 on coal mine dust exposures 

and associated health outcomes. NIOSH Docket 

Number 210 [http://www.cdc.gov/niosh/docket/ 

review/docket210/]. Date accessed: January 5, 2011. 

6NIOSH [2008]. Application of the ILO 

International Classification of Radiographs of 

Pneumoconioses to Digital Chest Radiographic 

Images: A NIOSH Scientific Workshop. Cincinnati, 

Continued 

mandated by the Mine Act, was 

developed to detect CWP and prevent 

progression in individual miners, while 

at the same time providing information 

for evaluation of temporal and 

geographic trends in pneumoconiosis. 

The Mine Act grants NIOSH general 

authority to issue regulations as the 

Institute deems appropriate in carrying 

out provisions of the Act and 

specifically directs that medical 

examinations for underground coal 

miners shall be given in accordance 

with specifications prescribed by 

NIOSH (30 U.S.C. 843(a), 957). 

To inform each miner of his or her 

health status, the Act requires that 

underground coal mine operators offer 

new workers a chest roentgenogram 

(hereafter chest radiograph or X-ray) 

through an approved facility as soon as 

possible after employment starts. Three 

years later a miner must be offered a 

second chest radiograph. If this second 

examination reveals evidence of 

pneumoconiosis, the miner is entitled to 

a third chest radiograph 2 years after the 

second. Further, all miners working in 

an underground coal mine must be 

offered a chest radiograph 

approximately every 5 years. All chest 

radiographs are to be given in 

accordance with specifications 

prescribed by the Secretary of Health 

and Human Services (30 U.S.C. 843(a)). 

Chest radiographs taken for the 

CWHSP are assessed by qualified and 

licensed physician A or B Readers. A 

Readers are physicians who interpret 

chest radiographs for clinical purposes. 

They will have demonstrated 

knowledge of the International Labour 

Office (ILO) Classification of 

Radiographs of Pneumoconioses by 

completing a NIOSH-approved course or 

submitting six radiographs with 

satisfactory classifications, as specified 

in 42 CFR 37.51. 

B Readers are physicians who have 

demonstrated proficiency in the use of 

the ILO classification system by taking 

and passing a specially-designed 

proficiency examination offered by 

NIOSH, as specified in 42 CFR 37.51. 

The NIOSH B Reader Program aims to 

ensure competency in the detection of 

pneumoconiosis by evaluating the 

ability of readers to classify a test set of 

radiographs, thereby creating and 

maintaining a pool of qualified readers 

having the skills and ability to provide 

accurate and precise classifications in 

accordance with ILO standards.3 The B 

Reader examination currently offered by 

NIOSH consists of the classification of 

125 chest radiographs over the course of 

6 hours; the test addresses proficiency 

in classification of small opacities, large 

opacities, pleural abnormalities, and 

certain other abnormalities that may 

appear in the lung radiographs. 

B Readers participate in national 

pneumoconiosis programs directed at 

coal miners and others who suffer from 

dust-related illness, and are also 

involved with epidemiologic 

evaluations, surveillance, and worker 

monitoring programs involving many 

types of pneumoconioses. In applying 

the ILO Classification, B Readers 

compare sets of standard images, which 

represent different types of 

abnormalities and levels of disease 

severity, with images of the individual 

being evaluated to identify parenchymal 

abnormalities (small and large 

opacities), pleural changes, and other 

features associated, or sometimes 

confused, with occupational lung 

disease. In the current ILO 

Classification, the B Reader is first asked 

to grade film quality and is then asked 

to categorize small opacities according 

to their presence, shape and size, 

location, and profusion. Large opacities 

are classified according to their 

presence and size. The B Reader also 

assesses the presence, location, width, 

extent, and degree of calcification of 

pleural abnormalities.4

Under NIOSH supervision (see 42 

CFR 37.53, as amended, below), a 

summary report based upon the 

readings of the periodic chest 

radiograph is sent to each participating 

coal miner, who then has the 

opportunity to take action to reduce 

further dust exposure if early dustinduced lung disease is detected. 

Miners with evidence of 

pneumoconiosis have specific rights to 

transfer to jobs with lower dust levels 

under 30 CFR part 90 (see also 42 CFR 

37.7). The combined results of these 

radiographic examinations of miners 

(radiographic surveillance) also enable 

NIOSH to track rates and patterns of 

CWP among the participating miners, so 

as to evaluate whether the implemented 

dust controls are effective in controlling 

CWP. 

A. Need for Rulemaking 

One goal of the Mine Act is to ensure 

that respirable dust concentrations in 

underground coal mines are sufficiently 

low to permit each miner the 

opportunity to be employed 

underground for a working lifetime 

without incurring any disability from 

pneumoconiosis or any other 

occupational lung disease (30 U.S.C. 

841(b)). Mine operators use primary 

prevention to accomplish this health 

outcome objective; that is, they 

implement procedures for recognizing, 

controlling, and monitoring exposures 

to hazardous conditions. 

However, because primary prevention 

measures may not be fully effective, 

secondary measures are recommended 

as a means to further protect workers. 

Secondary prevention involves ongoing 

miner health monitoring to recognize 

abnormalities early so that the miner 

has the necessary information to take 

appropriate action to prevent disease 

progression. Monitoring data are also 

periodically reviewed and analyzed to 

evaluate whether the primary 

preventive measures have been 

effective. This review permits the 

identification of work processes, 

exposures, or hazardous situations that 

require better control. Secondary 

prevention is particularly important 

when a risk to health remains in spite 

of adherence to recommended or 

permissible exposure levels, as has been 

demonstrated for coal miners.5

Chest radiography has historically 

been a valuable tool for monitoring the 

health of coal miners and other 

individuals potentially exposed to 

fibrogenic dusts such as silica or 

asbestos. Early changes due to 

pneumoconiosis are frequently 

identifiable on a high quality chest 

radiograph before an individual would 

otherwise seek medical attention. Over 

the years, methods for acquiring and 

interpreting film-screen chest 

radiographs have been continuously 

refined, to enhance the accuracy and 

usefulness of this technique as part of 

comprehensive occupational health 

protection programs. However, over the 

past decade digital radiography systems 

have been progressively replacing 

traditional analog film-based 

radiography for chest imaging.6


tkelley on DSK3SPTVN1PROD with PROPOSALS4
1362 Federal Register / Vol. 77, No. 5 / Monday, January 9, 2012 / Proposed Rules 

OH: U.S. Department of Health and Human 

Services, Public Health Service, Centers for Disease 

Control and Prevention, National Institute for 

Occupational Safety and Health. DHHS (NIOSH) 

Publication No. 2008–139. 

7See Work-Related Lung Disease (WoRLD) 

Surveillance System, Volume 1: Coal Workers’ 

Pneumoconiosis: Morbidity, Table 2012. CWXSP: 

Number and percentage of examined underground 

miners with coal workers’ pneumoconiosis (ILO 

category 1/0+) by tenure, 1970–2009, http://

www2a.cdc.gov/drds/WorldReportData/FigureTable

Details.asp?FigureTableID=2550&GroupRef

Number=T02-12. Accessed November 17, 2011. 

8U.S. Department of Labor, Mine Safety and 

Health Administration. Mining Industry Accident, 

Injuries, Employment, and Production Data— 

Address & Employment Self-Extracting Files. 

http://www.msha.gov/stats/part50/p50y2k/ 

aetable.htm. Accessed July 7, 2011. 

9Samei E, Ravin CE [2008]. Assuring image 

quality for classification of digital chest 

radiographs. In: NIOSH. Application of the ILO 

International Classification of Radiographs of 

Pneumoconioses to Digital Chest Radiographic 

Images: A NIOSH Scientific Workshop. Cincinnati, 

OH: U.S. Department of Health and Human 

Services, Public Health Service, Centers for Disease 

Control and Prevention, National Institute for 

Occupational Safety and Health. DHHS (NIOSH) 

Publication No. 2008–139. 

In order to retain the recognized 

benefits of radiographic health 

monitoring as a preventive health 

measure that is easily accessible by 

dust-exposed workers, it is necessary to 

require that underground coal mine 

operators furnish NIOSH with a current 

roster of miners’ names and addresses. 

CWHSP has found that directly 

contacting coal miners who are due for 

a chest examination results in a higher 

number of miners who participate in the 

Program. In 1990, NIOSH responded to 

declining underground coal miner 

participation in the Program by 

obtaining work rosters for contact 

information and sending notifications of 

availability of chest X-ray surveillance 

directly to the miners. Over the next few 

years, this led to increased participation 

in the Program.7 Coal miners themselves 

have indicated that they would prefer to 

receive a letter from CWHSP at their 

residence, rather than being notified by 

their employer, because they feel that 

direct contact with the Program 

provides them greater confidentiality. 

Also, in the experience of CWHSP, the 

increased family involvement that 

follows from receipt of a letter at home 

improves Program participation. Almost 

all underground coal mine operators 

(approximately 505 establishments 8) 

provide CWHSP with a roster of 

employees. The rare instance of an 

operator refusing to comply with the 

request resulted in no coal miners 

employed by a non-compliant operator 

participating in the Program. NIOSH is 

concerned that further noncompliance 

with CWHSP’s request will lead to 

lower rates of participation in the 

Program, and result in higher rates of 

pneumoconiosis. An alternative to the 

roster requirement—asking the mines to 

post Program information on a bulletin 

board in the mine—has been found to be 

ineffective and has not resulted in the 

same level of participation that has been 

demonstrated by direct mailings. 

Finally, previously effective 

approaches to radiographic monitoring 

need to be modified to reflect the 

different characteristics of digital 

imaging compared to film-screen 

radiography. Additionally, due to the 

broad diversity of hardware and 

software utilized in digital imaging, 

specifications are required to assure that 

the operational characteristics of the 

image acquisition and display systems 

are sufficiently standardized to support 

uniformity among these health 

assessments. In addition, they must 

assure confidentiality to the extent 

permitted by law, data integrity, and 

interoperability.9 Most importantly, 

they must permit accurate identification 

of the early changes seen in dust-related 

diseases. 

B. Scope of Rulemaking 

Existing regulations under 42 CFR 

part 37 provide rules and specifications 

for giving, interpreting, classifying, and 

submitting chest radiographs as 

required under section 203 of the 

Federal Mine Safety and Health Act of 

1977, as amended (30 U.S.C. 843). 

Those rules will essentially remain in 

effect: This rulemaking will not 

substantially alter the current standards, 

but will update the terminology used in 

the current standards (e.g., 

‘‘roentgenogram’’ to ‘‘radiograph’’) and 

include edits to maintain the accuracy 

of external references. 

Significantly, the new rule would 

expand the availability of chest 

radiographic examinations by 

establishing additional options for 

giving, interpreting, classifying, and 

submitting digitally-acquired 

radiographs under the same scope as the 

existing rule does for film radiographs. 

The proposed rule would establish the 

minimum specifications for methods, 

procedures, quality assurance, 

documentation, and equipment 

including computer software for 

facilities seeking approval to perform 

and submit digital radiographic 

examinations as well as the physician 

readers who interpret, classify, and 

submit reports using those radiographs. 

The proposed rule would also make 

limited changes to general requirements 

to reflect current terminology (such as 

the use of ‘‘radiograph’’ instead of 

‘‘roentgenogram’’ which is no longer 

commonly used), practice or needs, 

such as requiring mine operators to 

provide a roster of current miners to 

NIOSH, which uses this information to 

promote miner participation in the Coal 

Workers’ Health Surveillance Program. 

The proposed rule will not modify 

existing requirements for miner 

radiographic examinations, eligibility, 

or other rights, including transfer of 

affected miners in accordance with 30 

CFR part 90. 

C. Impact of Rulemaking 

The U.S. Department of Labor (DOL) 

will likely amend its Black Lung 

Benefits Act (BLBA) program 

regulations to correspond with the 

changes proposed here. The BLBA 

provides disability compensation and 

medical benefits to miners disabled by 

pneumoconiosis and monthly 

compensation to their eligible survivors 

(30 U.S.C. 901–944). Because DOL is 

required to consult with NIOSH on the 

development of criteria for medical tests 

for coal miners (30 U.S.C. 902(f)(1)(D)), 

DOL has modeled its technical 

requirements for chest radiographs on 

those adopted by NIOSH for the Coal 

Workers’ Health Surveillance Program 

(see 20 CFR 718.102 and 20 CFR Part 

718 Appendix A). DOL’s Occupational 

Safety and Health Administration 

(OSHA) might also consider amending 

its current asbestos regulations for 

general industry, shipyard employment, 

and construction (29 CFR 1910.1001 

Appendix E, 29 CFR 1915.1001 

Appendix E, and 29 CFR 1926.1101 

Appendix E, respectively). OSHA’s 

asbestos regulations are related to this 

proposed rulemaking, although they are 

not explicitly linked by statute or 

regulation. 

The DOL standards refer to chest 

‘‘roentgenograms,’’ an outdated term 

which NIOSH proposes to replace with 

the more contemporary ‘‘radiograph’’ as 

discussed below in the summary of the 

proposed digital standards. The DOL 

standards also rely upon the same ILO 

standards for the classification of 

radiographs, and might need to be 

amended to comport with the 2011 

version of the ILO Classification, as 

referenced in this proposed rule. 

Finally, the DOL standards refer to filmbased images and might need to be 

expanded to refer to digitally-acquired 

images in order to allow for such images 

to be used for purposes of determining 

eligibility for compensation. 


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III. Summary of Proposed Rule 

A. Subpart—Chest Radiographic 

Examinations 

This proposed rule would establish 

new requirements for digital 

radiography under existing part 37 of 42 

CFR—Specifications for Medical 

Examinations of Underground Coal 

Miners. The new provisions would 

supplement and update the existing 

requirements for film-screen 

radiographs by establishing standards 

for digital radiographs. The following is 

a section-by-section summary which 

describes and explains the provisions of 

the rule. Table 1 matches the current 

regulatory provisions with the 

corresponding proposed provisions. The 

public is invited to provide comment on 

any aspect of the proposed rule. The 

proposed regulatory text for the 

proposed rule is provided in the last 

section of this notice. 

TABLE 1—NEW AND PROPOSED PROVISIONS

Current regulation Proposed regulation 

37.2 Definitions 37.2 Definitions 

37.3 Chest roentgenograms required for miners 37.3 Chest radiographs required for miners 

37.4 Plans for chest roentgenographic examinations 37.4 Plans for chest radiographic examinations 

37.5 Approval of plans 37.5 Approval of plans 

37.6 Chest roentgenographic examinations conducted by the Secretary 37.6 Chest radiographic examinations conducted by the Secretary 

37.7 Transfer of affected miner to less dusty area 37.7 Transfer of affected miner to less dusty area 

37.8 Roentgenographic examination at miner’s expense 37.8 Radiographic examination at miner’s expense 

37.20 Miner identification document 37.20 Miner identification document 

37.40 General provisions 37.40 General provisions 

37.41 Chest roentgenogram specifications 37.41 Chest radiograph specifications—film 

37.42 Approval of roentgenographic facilities 37.42 Chest radiograph specifications—digital radiography systems 

37.43 Protection against radiation emitted by Roentgenographic 

equipment 

37.43 Approval of radiographic facilities that use film 

37.44 Approval of radiographic facilities that use digital radiography 

systems 

37.45 Protection against radiation emitted by radiographic equipment 

37.50 Interpreting and classifying chest roentgenogram 37.50 Interpreting and classifying chest radiographs—film 

37.51 Proficiency in the use of systems for classifying the 

pneumoconioses 

37.51 Interpreting and classifying chest radiographs—digital radiography systems 

37.52 Method of obtaining definitive interpretations 37.52 Proficiency in the use of systems for classifying the 

pneumoconioses 

37.53 Notification of abnormal roentgenographic findings 37.53 Method of obtaining definitive interpretations 

37.54 Notification of abnormal radiographic findings 

37.60 Submitting required chest roentgenograms and miner identification documents 37.60 Submitting required chest radiographs and miner identification 

documents 

37.70 Review of interpretations 37.70 Review of interpretations 

37.80 Availability of records 37.80 ability of records 

37.200 Scope 37.200 Scope 

37.201 Definitions 37.201 Definitions 

37.202 Payment for autopsy 37.202 Payment for autopsy 

37.203 Autopsy specifications 37.203 Autopsy specifications 

37.204 Procedure for obtaining payment 37.204 Procedure for obtaining payment 

Section 37.1 Scope 

This existing section provides the 

scope of these provisions, and remains 

unchanged from the current regulation. 

Section 37.2 Definitions 

This existing section contains 

definitions for terms that appear 

throughout part 37. A number of terms 

appearing in the current regulations 

remain unchanged, including ‘‘Act,’’ 

‘‘convenient time and place,’’ ‘‘MSHA,’’ 

‘‘miner,’’ ‘‘operator,’’ and ‘‘Secretary.’’ 

This section proposes to amend the 

following terms to reflect updated 

terminology and references: ‘‘NIOSH,’’ 

and ‘‘chest radiograph.’’ We propose to 

change ‘‘pre-employment physical 

examination’’ to ‘‘pre-placement 

physical examination’’ to be consistent 

with the requirements of the Americans 

with Disabilities Act of 1990 (42 U.S.C. 

12112(d)) (ADA). The ADA prohibits an 

employer from asking or requiring a job 

applicant to take a medical examination 

or inquiring about whether an applicant 

has a disability before an offer of 

employment has been made. However, 

the ADA does allow an employer to 

require a medical examination after an 

offer of employment has been made, 

subject to certain restrictions. ‘‘Panel of 

B Readers’’ would be amended to 

indicate that the panel comprises all 

currently-approved B Readers. 

Finally, this section includes 

definitions of the following proposed 

new terms: ‘‘digital radiography 

systems,’’ ‘‘computed radiography,’’ 

‘‘digital radiography,’’ ‘‘NIOSH 

representatives,’’ ‘‘qualified medical 

physicist,’’ ‘‘radiographic technique 

chart,’’ ‘‘radiologic technologist,’’ and 

‘‘soft copy.’’ 

Section 37.3 Chest Radiographs 

Required for Miners 

This existing section requires mine 

operators to provide miners an 

opportunity to receive a chest 

radiograph. We propose a change to this 

provision to delete and replace outdated 

text. For example, in § 37.3(a), 

‘‘roentgenogram’’ would be replaced by 

‘‘radiograph.’’ Similarly in § 37.3(a)(1), 

‘‘ALOSH’’ would be replaced with 

‘‘NIOSH.’’ 

Paragraph (b)(1) would be amended to 

remove reference to a pre-employment 

physical examination, which is 

prohibited by the Americans with 

Disabilities Act of 1990 (42 U.S.C. 

12112(d)). Paragraph (b)(3) would be 

amended to further clarify the 

classification of simple 

pneumoconioses. 


tkelley on DSK3SPTVN1PROD with PROPOSALS4
1364 Federal Register / Vol. 77, No. 5 / Monday, January 9, 2012 / Proposed Rules 

Section 37.4 Plans for Chest 

Radiographic Examinations 

This existing section requires that 

mine operators submit to NIOSH a Coal 

Mine Operator’s Plan (Form CDC/ 

NIOSH (M)2.10, OMB 0920–0020, exp. 

June 30, 2014) for chest radiographic 

examinations, including the beginning 

and ending dates of the 6-month period 

for voluntary examinations, and the 

name and location of the approved Xray facility or facilities. 

We propose to amend § 37.4(a), (d), 

(e), and (f) to update terminology to 

reflect ‘‘radiographic’’ for 

‘‘roentgenographic’’ and ‘‘NIOSH’’ for 

‘‘ALOSH.’’ 

We propose to amend § 37.4(a)(3) to 

specifically require the mine operator to 

submit a roster with the names and 

current addresses of covered miners 

with the operator’s proposed plan. This 

is current practice and permits mailings 

directly from NIOSH to miners, which 

both emphasizes the extent of the 

confidentiality exercised by the program 

and explains the importance of the 

health surveillance program. As 

discussed above, such direct 

communication from NIOSH has proven 

important in encouraging miners’ 

participation. 

We propose to amend § 37.4(a)(6) to 

specify that when a coal mine operator 

examination plan lists a NIOSHapproved X-ray facility that uses a 

digital radiographic system, the listed 

physician who provides the first clinical 

reading of a coal miner’s digital chest 

radiograph must have appropriate 

qualifications, but is not required to 

perform an ILO classification for 

pneumoconiosis. These initial clinical 

readings would therefore not be 

required to meet the specifications for 

pneumoconiosis classification listed in 

§ 37.51 (b), (c), (d), and (e). This should 

increase the number of digital 

radiographic facilities available to 

miners that can be listed by coal mine 

operators on examination plans. 

We propose to amend § 37.4(a)(7)(ii) 

to extend the existing confidentiality 

provisions for film radiographs to digital 

radiographs, including requiring, to the 

extent that is technically feasible for the 

imaging system used, the permanent 

deletion or rendering permanently 

inaccessible of all digital files at the 

facility. We further propose to amend 

this section to be consistent with the 

requirements of the Americans with 

Disabilities Act, which prohibits the use 

of pre-employment medical 

examinations. We propose to strike the 

reference in this paragraph to the preemployment examination and 

disclosure of information gained during 

that examination. 

Section 37.5 Approval of Plans 

This existing section outlines the 

process undertaken by the Secretary of 

HHS to approve or deny approval of a 

Coal Mine Operator’s Plan (Form CDC/ 

NIOSH (M)2.10, OMB 0920–0020, exp. 

June 30, 2014). We propose to amend 

this section to redact outdated text and 

to correct gender-exclusive language. 

Section 37.6 Chest Radiographic 

Examinations Conducted by the 

Secretary 

This existing section details the 

conditions under which the HHS 

Secretary will determine whether to 

conduct a chest radiographic 

examination. We propose to amend this 

section to replace outdated text with 

current terminology. 

Section 37.7 Transfer of Affected 

Miner to Less Dusty Area 

Under 30 CFR part 90, miners whose 

radiographs show specific categories of 

pneumoconiosis are offered the right to 

frequent workplace dust monitoring, 

and transfer to a job environment with 

not more than 1 mg/m3 respirable dust 

levels, if needed and such a job is 

available at the mine. If such a work 

location is not available, transfer is 

offered to the job with the lowest 

exposure below 2 mg/m3, which is the 

current permissible exposure limit for 

respirable dust enforced by MSHA in 

coal mines. We propose to amend this 

section to replace outdated text with 

current terminology. Also, we propose 

to replace ‘‘2 mg/m3’’ with ‘‘the 

maximum respirable dust concentration 

permitted by MSHA’’ and replace ‘‘1 

mg/m3’’ with ‘‘50 percent of the 

maximum respirable dust concentration 

permitted by MSHA.’’ The revised 

wording would not impact current 

requirements; however it would remain 

consistent with any MSHA rulemaking 

that alters the relevant permissible 

exposure limits. 

Section 37.8 Radiographic 

Examination at Miner’s Expense 

This existing section provides for any 

miner who wishes to obtain a 

radiographic examination at his or her 

own expense. We propose to amend this 

section only to replace the outdated 

‘‘ALOSH’’ with ‘‘NIOSH.’’ 

Section 37.20 Miner Identification 

Document 

This existing section requires the 

completion of a Miner Identification 

Document (Form CDC/NIOSH (M)2.9, 

OMB 0920–0020, exp. June 30, 2014) for 

each miner when the chest radiograph 

is made. We propose to amend this 

section only to replace 

‘‘roentgenographic’’ and 

‘‘roentgenogram’’ with ‘‘radiographic’’ 

and ‘‘radiograph.’’ 

Section 37.40 General Provisions 

This existing section outlines general 

provisions for chest radiographic 

examinations. We propose to amend 

this section to update the terminology. 

Section 37.41 Chest Radiograph 

Specifications—Film 

This existing section establishes 

performance standards for the 

acquisition of chest radiographs using 

film-screen technology. We propose to 

amend this section to update 

terminology and standards. We propose 

to add § 37.41(c) to require that a 

radiologic technologist perform the 

radiograph. This requirement is new. 

The existing rule does not clearly 

specify the qualifications of the provider 

who performs the radiologic 

examination. In light of ongoing 

concerns related to radiation exposure, 

it is necessary to specify that this 

provider have documented 

qualifications. 

We propose to amend § 37.41(i)(7) to 

remove the current language, ‘‘[w]hen 

using over 90kV,’’ because proposed 

§ 37.42(e), below, would require that 

radiographs be made by units having 

generators with a minimum rating of 

300 mA at 125 kVp. We also propose to 

amend § 37.41(m) to remove the word 

‘‘densitometric,’’ as the test object may 

evaluate characteristics of the exposure 

in addition to density. 

We also propose to amend § 37.41(h) 

to remove the reference to Part F of the 

Suggested State Regulations for the 

Control of Radiation, of the Conference 

of Radiation Control Program Directors 

(Rev 2009). The beam limiting device 

must be of the type described in 21 CFR 

1020.31(d), (e), (f), and (g). 

Finally, we propose to remove 

§ 37.41(i)(9), which requires that each 

facility shall establish a formal quality 

assurance program. This requirement 

would be instead inserted into proposed 

§ 37.43, which would set standards for 

the approval of radiographic facilities 

that use film (see below). 

Section 37.42 Chest Radiograph 

Specifications—Digital Radiography 

Systems 

This proposed section establishes 

performance standards for the 

acquisition of chest radiographs using 

digital radiography systems, including 

digital radiography and computed 

radiography. We propose adding this 


tkelley on DSK3SPTVN1PROD with PROPOSALS4
Federal Register / Vol. 77, No. 5 / Monday, January 9, 2012 / Proposed Rules 1365 

10Samei E [2008]. Acquisition of digital chest 

images for pneumoconiosis classification: Methods, 

procedures, and hardware. In: NIOSH. Application 

of the ILO International Classification of 

Radiographs of Pneumoconioses to Digital Chest 

Radiographic Images: A NIOSH Scientific 

Workshop. Cincinnati, OH: U.S. Department of 

Health and Human Services, Public Health Service, 

Centers for Disease Control and Prevention, 

National Institute for Occupational Safety and 

Health. DHHS (NIOSH) Publication No. 2008–139. 

11Franzblau A, Kazerooni EA, Sen A, Goodsitt 

MM, Lee SY, Rosenman KD, Lockey JE, Meyer CA, 

Gillespie BW, Petsonk EL, Wang ML [2009]. 

Comparison of digital radiographs with film 

radiographs for the classification of 

pneumoconiosis. Acad Radiol 16(6):669–677. 

Sen A, Lee SY, Gillespie BW, Kazerooni EA, 

Goodsitt MM, Rosenman KD, Lockey JE, Meyer CA, 

Petsonk EL, Wang ML, Franzblau A [2010]. 

Comparison of reliability of classification for 

pneumoconiosis of film and digital radiographs: A 

modeling approach. Acad Radiol 17(4):511–519. 

Laney AS, Petsonk EL, Wolfe AL, Attfield MD 

[2009]. Comparison of storage phosphor computed 

radiography with conventional film-screen 

radiography in the recognition of pneumoconiosis. 

Eur Respir J, published ahead of print November 19, 

2009. 

12Flynn MJ [2008]. Image presentation: 

Implications of processing and display. In: NIOSH. 

Application of the ILO International Classification 

of Radiographs of Pneumoconioses to Digital Chest 

Radiographic Images: A NIOSH Scientific 

Workshop. Cincinnati, OH: U.S. Department of 

Health and Human Services, Public Health Service, 

Centers for Disease Control and Prevention, 

National Institute for Occupational Safety and 

Health. DHHS (NIOSH) Publication No. 2008–139. 

13Shepard SJ, Wang J, Flynn M, Gingold E, 

Goldman L, Krugh K, Leong DL, Mah E, Ogden K, 

Peck D, Samei E, Willis C [2009]. An exposure 

indicator for digital radiography. Report of AAPM 

Task Group 116. College Park, MD: American 

Association of Physicists in Medicine. AAPM 

Report No. 116. 

Rossi R, Lin PJ, Rauch P, Strauss K [1985]. 

Performance specifications and acceptance testing 

for X-ray generators and automatic exposure control 

devices. Report of the Diagnostic X–Ray Imaging 

Committee Task Group on Performance 

Specifications and Acceptance Testing for X–Ray 

Generators and Automatic Exposure Control 

Devices. AAPM Report No. 14. 

Seibert JA, Bogucki TM, Ciona T, Huda W, 

Karellas A, Mercier J, Samei E, Shepart SJ, Steward 

B, Strauss K, Suleiman O, Tucker D, Uzenoff R, 

Weiser JC, Willis C [2006]. Acceptance testing and 

quality control of photostimulable storage phosphor 

imaging systems. Report of AAPM Task Group 10. 

College Park, MD: American Association of 

Physicists in Medicine. AAPM Report No. 93. 

new section in its entirety; it is 

patterned after the existing § 37.41— 

Chest radiographic specifications for 

film. 

Proposed § 37.42(a) would establish 

basic logistical requirements for 

conducting chest radiographic 

examination. For example, under this 

provision, the imaging facility would be 

required to provide a dressing area. This 

provision is identical to the existing 

regulation for film, § 37.41(b). 

Proposed § 37.42(b) would specify 

minimum requirements for the position 

of the subject of the radiograph and for 

the resolution and positioning of the 

resulting image. The required size and 

positioning of the X-ray detectors for 

digital systems is identical to that in the 

existing regulation for film-screen 

systems (§ 37.41(a)). Exact specifications 

for the digital imaging detector are 

provided because detectors must 

provide sufficient image size and gray 

scale depth to demonstrate the required 

subtle contrasts, and sufficient density 

of pixels to offer adequate resolution for 

the fine linear fibrotic shadows.10 The 

specification of a maximum pixel pitch 

of 200 mm, a minimum gray-scale bit 

depth of 10, and spatial resolution of at 

least 2.5 line pairs per millimeter are 

based upon the existing peer-reviewed 

research comparing digital and 

traditional imaging and ensures that the 

use of digital radiography systems will 

not result in reduced ability to recognize 

and quantify the abnormalities.11

Commercially-available imaging 

systems are able to meet these 

specifications.12

Proposed § 37.42(c) would require 

that chest radiographs obtained 

pursuant to these provisions must be 

made by a qualified radiologic 

technologist. 

Proposed § 37.42(d) would specify the 

required size of the X-ray machine’s 

focal spot. This proposed provision 

would follow the existing regulation for 

film (§ 37.41(c)). 

Proposed § 37.42(e) would specify the 

minimum amperage and voltage 

required to produce chest radiographs. 

This section would be identical to the 

existing regulation for film, § 37.41(d), 

but with updated terminology. 

Proposed § 37.42(f) would require 

radiographic equipment be used with a 

power supply that complies with the 

X-ray machine’s manufacturer 

specifications. Adequately conditioned 

power is needed for consistent 

generation of the radiation exposure 

needed for imaging. The requirement to 

meet minimum power supply 

recommendations for the equipment 

assures that the imaging system can 

perform as intended and specified by 

the manufacturer. 

Proposed § 37.42(g) would require 

that radiographic equipment has a 

beam-limiting device to reduce the 

amount of scatter and off-focus 

radiation. While this provision largely 

mirrors the provision for film-screen 

systems (§ 37.41(g)), it also specifies that 

electronic means for limiting the size of 

the final image shall not be used. 

Electronic ‘‘shutters’’ are available for 

some digital radiography systems and 

can constrain image size but do not 

limit radiation exposure, and thus their 

use is prohibited to reduce the adverse 

health impact on the miner of 

unnecessary exposure to ionizing 

radiation associated with the 

radiograph. 

Proposed § 37.42(h) would require the 

use of radiographic technique charts 

that are developed specifically for the 

X-ray system and detector combination 

used at a facility. If automated exposure 

control devices are used, they should be 

documented using professionally 

recommended methods; such 

information should be stored for 5 years 

after the miner’s examination. NIOSH 

believes that retaining such records for 

5 years is already standard business 

practice. Maintaining records is 

necessary to permit individuals at the 

facility to audit their own adherence to 

the guidance. Failure to maintain 

documentation is much easier to 

demonstrate and enforce than specific 

elevated radiation exposures for 

individual examinations. Five years was 

chosen as a compromise between 

minimizing records storage burden and 

maintaining the ability to perform 

meaningful audits both for NIOSH and 

for the facility staff. 

The proposed specifications for 

digital radiography systems follow 

existing regulations for film 

(§ 37.41(h)(3)) requiring specified 

exposure settings. Because of the 

recognized potential for higher ionizing 

radiation exposures using digital 

radiography systems, we have included 

additional requirements to limit these 

exposures in accordance with 

recommendations established by the 

American Association of Physicists in 

Medicine.13

Proposed § 37.42(i)(1) would require 

that the maximum exposure time not 

exceed 50 milliseconds except for 

subjects of a certain size. This provision 

would mirror the existing regulation for 

film-screen technology (§ 37.41(h)(1), 

although the text is modified to use 

contemporary timing units. 

Proposed § 37.42(i)(2) would specify 

the required distance from the source or 

focal spot to the detector. This provision 

mirrors the existing regulation for film 

(§ 37.41(g)) but with additional text 

clarifying metric units. 

Proposed § 37.42(i)(3) would specify 

the required exposure setting for digital 

radiographs and incorporate by 

reference current professional standards 

intended to limit exposures from digital 

radiographs. This proposed section 

mirrors existing regulations for filmscreen technology (§ 37.41(h)(3)). 

Proposed § 37.42(i)(4) would establish 

that digital radiography system 

performance, including image signal-tonoise and detective quantum efficiency, 

be evaluated and meet the standards of 


tkelley on DSK3SPTVN1PROD with PROPOSALS4
1366 Federal Register / Vol. 77, No. 5 / Monday, January 9, 2012 / Proposed Rules 

14 DICOM is a widely-accepted standard for 

handling, storing, printing, and transmitting 

medical imaging information. DICOM is managed 

by the National Electrical Manufacturers 

Association. 

15NIOSH [2008]. Application of the ILO 

International Classification of Radiographs of 

Pneumoconioses to Digital Chest Radiographic 

Images: A NIOSH Scientific Workshop. Cincinnati, 

OH: U.S. Department of Health and Human 

Services, Public Health Service, Centers for Disease 

Control and Prevention, National Institute for 

Occupational Safety and Health. DHHS (NIOSH) 

Publication No. 2008–139. 

16Clunie DA. Standardizing file formats, security, 

and integration of digital chest image files for 

pneumoconiosis classification. In: NIOSH. 

Application of the ILO International Classification 

of Radiographs of Pneumoconioses to Digital Chest 

Radiographic Images: A NIOSH Scientific 

Workshop. Cincinnati, OH: U.S. Department of 

Health and Human Services, Public Health Service, 

Centers for Disease Control and Prevention, 

National Institute for Occupational Safety and 

Health. DHHS (NIOSH) Publication No. 2008–139. 

17Samei E [2008]. Acquisition of digital chest 

images for pneumoconiosis classification: Methods, 

procedures, and hardware. In: NIOSH. Application 

of the ILO International Classification of 

Radiographs of Pneumoconioses to Digital Chest 

Radiographic Images: A NIOSH Scientific 

Workshop. Cincinnati, OH: U.S. Department of 

Health and Human Services, Public Health Service, 

Centers for Disease Control and Prevention, 

National Institute for Occupational Safety and 

Health. DHHS (NIOSH) Publication No. 2008–139. 

Franzblau A, Kazerooni EA, Sen A, Goodsitt MM, 

Lee SY, Rosenman KD, Lockey JE, Meyer CA, 

Gillespie BW, Petsonk EL, Wang ML [2009]. 

a qualified medical physicist in 

accordance with current professional 

standards, which are incorporated by 

reference in this section. This section 

would also govern the use of image 

management software. Digital systems 

use direct or indirect quantification of 

electronic signals from the detectors, 

and thus the character and quality of the 

resulting image is affected by both 

hardware and software signal 

management. To ensure that images 

collected for the purposes of this 

regulation using digital systems are 

adequate, it is important that approved 

imaging systems satisfy the relevant 

contemporary professionally 

recommended minimum performance 

criteria. Further, to improve 

comparability in the character of chest 

radiographic images submitted by 

different approved facilities for the 

purposes of this regulation, this section 

would require that image management 

software and settings for routine chest 

imaging be used. 

In addition to management software, 

manufacturers of digital radiography 

systems provide unique proprietary 

versions of image modifying software, 

and the resulting images have distinctly 

different appearances. There is currently 

no scientific consensus that a specific 

approach to image enhancement 

software provides superior performance 

in imaging pneumoconiotic opacities. 

Therefore, this section would prohibit 

the use of image enhancement, except to 

the extent that some enhancement 

features might be integral to the digital 

radiography system and hence are not 

elective; for such cases, this section 

would specify that image enhancement 

be minimized to the extent permitted by 

the system. 

Proposed § 37.42(i)(5) would establish 

the Digital Imaging and 

Communications in Medicine (DICOM) 

standard 14 as the relevant data storage 

and transmission standard. At a 2008 

NIOSH workshop, entitled Application 

of the ILO International Classification of 

Radiographs of Pneumoconioses to 

Digital Chest Radiographic Images, 

participants evaluated digital chest 

radiographic image file formats, and 

found that aside from DICOM, there are 

currently no other adequately specified 

digital image formats that support the 

resolution, security, and interoperability 

required for this application.15 Chest 

radiographic images obtained using 

digital systems are stored and 

transferred as electronic data files. To 

ensure the integrity of the information, 

patient/worker confidentiality, full 

access by appropriate parties to the 

complete data file, compatibility with 

hardware systems from various 

manufacturers, and uniformity of image 

viewing and data management, the 

proposed rule would require that images 

collected for the purposes of this 

regulation using digital systems be 

formatted using the industry 

standardized electronic format, and that 

any data compression employed be 

lossless. Physical, technical, and 

administrative controls are specified to 

prevent unauthorized access to 

protected health information and 

confidential medical findings, during 

data acquisition, storage, and transfer. 

To support the uniform grayscale 

standard display function of image 

display devices, images must be 

formatted as DICOM ‘‘DX’’ objects.16 To 

enable auditing of radiation exposure 

data over time, the facility would be 

required to maintain either written or 

electronic records, formatted according 

to industry standards when possible. 

Proposed § 37.42(i)(6) would allow 

NIOSH the discretion to require the use 

of a test object for an evaluation of 

image quality. This section is identical 

to existing film regulation § 37.41(l), 

although the term ‘densitometric’ has 

been omitted in describing the test 

object, as the object may evaluate 

characteristics of the exposure in 

addition to density. 

Proposed § 37.42(i)(7) would require 

computed radiography (X-ray image 

acquisition systems that detect signals 

using a cassette-based photostimulable 

storage phosphor) imaging plates to be 

inspected regularly and cleaned when 

necessary. This specification preserves 

the existing required periodicity of 

cleaning because, for storage phosphor 

digital systems as with film-screen 

systems, periodic cleaning of equipment 

is necessary to reduce the possibility of 

image artifacts. 

Proposed § 37.42(i)(8) would require 

the use of a grid or air gap for reducing 

radiation scatter. This section mirrors 

the existing regulation for film 

(§ 37.41(h)(7)) with additional language 

addressing interference patterns. Such 

patterns can arise using digital 

techniques, and can interfere with 

image classification and the detection of 

abnormalities. 

Proposed § 37.42(i)(9) would establish 

the geometry of the radiographic system. 

This section mirrors existing film 

regulation § 37.41(h)(8), with text 

amended to reflect the digital 

technology rather than film. 

Proposed § 37.42(i)(10) would require 

that radiographic equipment meet 

recommended environmental 

temperature and humidity thresholds 

set by the manufacturer. This 

requirement would be exclusive to 

digital radiography systems, and would 

ensure that the imaging system can 

perform as intended and as specified by 

the manufacturer. 

Proposed § 37.42(i)(11) would ensure 

that the miner receives a chest 

radiograph determined to be of 

acceptable quality before being advised 

that the examination is concluded. In 

the event of a substandard radiograph, 

under this section, a miner would 

immediately be given another. Finally, 

this section would also require that 

unacceptable digital image files 

immediately be permanently deleted or 

rendered inaccessible in the event that 

permanent deletion is not 

technologically feasible. These 

requirements are identical to that for 

film (§ 37.41(j)) except that the text 

refers to the deletion of digital files 

rather than the disposal of films. 

Proposed § 37.42(j)(1) and (2) would 

prohibit the use of digital images 

derived from film-screen chest 

radiographs for the purposes of this 

rule. Similarly, images acquired using 

digital systems and then printed on 

transparencies would also be 

prohibited. Research has shown that 

these approaches do not assure similar 

performance to that obtained from film 

under the existing regulations 

(§ 37.41).17


tkelley on DSK3SPTVN1PROD with PROPOSALS4
Federal Register / Vol. 77, No. 5 / Monday, January 9, 2012 / Proposed Rules 1367 

Comparison of digital radiographs with film 

radiographs for the classification of 

pneumoconiosis. Acad Radiol 16(6):669–677. 

Suganuma N, Murata K, Kusaka Y [2008]. CR and 

FPD DR chest radiographic image parameters for the 

pneumoconioses: The Japanese approach and 

experience. In: NIOSH. Application of the ILO 

International Classification of Radiographs of 

Pneumoconioses to digital chest radiographic 

images: A NIOSH Scientific Workshop. Cincinnati, 

OH: U.S. Department of Health and Human 

Services, Public Health Service, Centers for Disease 

Control and Prevention, National Institute for 

Occupational Safety and Health. DHHS (NIOSH) 

Publication No. 2008–139. 

Franzblau A, Kazerooni EA, Goodsitt M [2009]. 

Digital X-ray imaging in pneumoconiosis screening: 

Future challenges for the NIOSH B Reader Program. 

In: NIOSH. The NIOSH B Reader Certification 

Program: Looking to the future. Cincinnati, OH: 

U.S. Department of Health and Human Services, 

Public Health Service, Centers for Disease Control 

and Prevention, National Institute for Occupational 

Safety and Health. DHHS (NIOSH) Publication No. 

2009–140. 

Section 37.43 Approval of 

Radiographic Facilities That Use Film 

Proposed § 37.43 would comprise the 

current requirements in existing 

§ 37.42—Approval of roentgenographic 

facilities. Proposed § 37.43(a) would 

base facility eligibility to participate in 

the Coal Workers’ Health Surveillance 

Program on a demonstrated ability to 

make high quality diagnostic chest 

radiographs. This section remains 

unchanged from the existing provision 

but for the addition of text indicating 

that an object other than the plastic step 

wedge objects may be used. Newer test 

objects have become available, and in 

the future, NIOSH may want to use a 

more compact and capable test object 

that is simpler to use than the step 

wedges. 

Proposed § 37.43(b) would specify 

requirements for an X-ray Facility 

Certification Document (Form CDC/ 

NIOSH (M)2.11, OMB 0920–0020, exp. 

June 30, 2014) describing each X-ray 

unit to be used to make chest 

radiographs. This section would be 

unchanged from the existing § 37.42(c) 

except for the replacement of outdated 

terminology, including incorporation by 

reference of National Council on 

Radiation Protection and Measurements 

(NCRP) Report No. 102. 

Proposed § 37.43(c) would establish 

that radiographs submitted with a 

facility application be evaluated by a 

qualified consultant or one or more 

individuals selected by NIOSH from the 

panel of B Readers. This section would 

be substantively unchanged from the 

existing § 37.42(d), although we propose 

to amend this section to replace 

outdated text with current terminology, 

specifically by substituting the term 

’medical physicist’ for ’radiological 

physicist.’ 

Proposed § 37.43(d) would describe 

NIOSH’s authority to conduct a physical 

inspection of the applicant’s facility to 

determine if the requirements of this 

subpart are being met. We propose to 

amend this section from the existing 

§ 37.42(e) by updating outdated 

terminology. 

Proposed § 37.43(e) would allow 

NIOSH the discretion to require a 

facility to resubmit radiographs of a test 

object, sample radiographs, or a Facility 

Certification Document for quality 

control purposes. It would also establish 

the conditions under which NIOSH may 

suspend or withdraw a facility’s 

approval and how notice must be given. 

We propose to amend this section from 

the existing § 37.43(f) by updating 

outdated terminology. 

Proposed § 37.43(f) would require that 

facilities establish a formal quality 

assurance program conforming to 

standards published by the American 

Association of Physicists in Medicine 

and incorporated by reference here. This 

provision would replace existing 

§ 37.41(h)(9), which requires that 

facilities establish a formal quality 

assurance program, with more specific 

quality assurance program guidelines. 

We propose that the program must be 

written, address radiation exposures, 

equipment maintenance, and image 

quality, and conform to the referenced 

professional standards. Several years 

ago, NIOSH initiated an image quality 

feedback program to try to improve the 

film quality; NIOSH therefore wishes to 

ensure that the facilities have 

documented quality assurance 

programs. This provision will also 

permit NIOSH to easily request copies 

of the documentation, and thus more 

easily determine if a facility has 

adequately addressed their image 

quality issues. 

Proposed § 37.43(g) would add the 

explicit requirement that facilities 

adhere to Federal, State, and local laws, 

as applicable, to protect the 

confidentiality and privacy of coal 

miners participating in the Program. 

Through this provision, NIOSH seeks to 

ensure that X-ray facilities maintain 

miners’ sensitive health information 

securely and protect it from disclosure 

to the extent permitted by law. 

Section 37.44 Approval of 

Radiographic Facilities That Use Digital 

Radiography Systems 

Proposed § 37.44 would establish 

standards for the approval of 

radiographic facilities that use digital 

radiography systems. These standards 

mirror those for film-screen technology. 

Proposed § 37.44(a)(1) would specify 

the requirements for a facility approval 

application, including an image of a test 

object, and six or more sample 

radiographs of quality acceptable to one 

or more individuals selected by NIOSH 

from the panel of B Readers and a 

qualified medical physicist. The 

existing requirements for facilities to 

demonstrate radiograph quality are 

continued (§ 37.42(b)) but to reduce the 

burden on facilities, radiographs made 

up to 60 days prior to the application 

may be submitted. The time extension 

(from the existing 15 days for film-based 

systems) eases the burden on applicants 

by giving them a longer window of time 

to select a representative image, while 

continuing to ensure that the images 

that are submitted reflect the facility’s 

contemporary image quality; changes in 

digital image quality are unlikely to 

occur in the time frame indicated (i.e., 

60 days). In the past, wet systems such 

as film processors and chemicals could 

get diluted or dirty in shorter times 

when many films were processed, 

however, because there are no liquids 

and very few moving parts in digital 

systems, the time frame for quality 

deterioration is longer, and thus a longer 

time is more convenient but still should 

be representative of the digital image 

quality. This provision would also 

require the image files to be submitted 

using a secure electronic file transfer 

method approved by NIOSH, or on 

standard portable media and meet the 

current DICOM specifications for 

diagnostic media interchange. 

Proposed § 37.44(a)(2) would specify 

the contents of the X-ray Facility 

Certification Document. This paragraph 

would continue the existing 

requirement for documentation and 

inspection of eligible facilities by a 

qualified expert within 1 year preceding 

the date of the application (§ 37.42(c)), 

and would clarify that the expert must 

be a medical physicist. NIOSH has 

always expected that a medical 

physicist perform these evaluations, and 

now intends to codify that expectation. 

Proposed § 37.44(b) would require 

that facilities maintain relevant local, 

State, or Federal licensure and 

certification. The existing requirement 

that radiographic facilities conform to 

applicable State and Federal regulations 

(§ 37.43) is continued. 

Proposed § 37.44(c) would allow 

NIOSH the discretion to conduct a site 

inspection of the facility. Existing 

regulations for film (§ 37.42(e)) specify 

periodic inspections, and this 

requirement is continued for digital 

systems. 

Proposed § 37.44(d) would allow 

NIOSH the discretion to require a 

facility to resubmit image files of the 

test object, sample radiographs, or 


tkelley on DSK3SPTVN1PROD with PROPOSALS4
1368 Federal Register / Vol. 77, No. 5 / Monday, January 9, 2012 / Proposed Rules 

18Samei E [2008]. Acquisition of Digital Chest 

Images for Pneumoconiosis Classification: Methods, 

Procedures, and Hardware. In: NIOSH. Application 

of the ILO International Classification of 

Radiographs of Pneumoconioses to Digital Chest 

Radiographic Images: A NIOSH Scientific 

Workshop. Cincinnati, OH: U.S. Department of 

Health and Human Services, Public Health Service, 

Centers for Disease Control and Prevention, 

National Institute for Occupational Safety and 

Health. DHHS (NIOSH) Publication No. 2008–139. 

19NIOSH [2008]. Application of the ILO 

International Classification of Radiographs of 

Pneumoconioses to Digital Chest Radiographic 

Images: A NIOSH Scientific Workshop. Cincinnati, 

OH: U.S. Department of Health and Human 

Services, Public Health Service, Centers for Disease 

Control and Prevention, National Institute for 

Occupational Safety and Health. DHHS (NIOSH) 

Publication No. 2008–139. 

20Samei E, Ravin CE [2008]. Assuring image 

quality for classification of digital chest 

radiographs. In: NIOSH. Application of the ILO 

International Classification of Radiographs of 

Pneumoconioses to Digital Chest Radiographic 

Images: A NIOSH Scientific Workshop. Cincinnati, 

OH: U.S. Department of Health and Human 

Services, Public Health Service, Centers for Disease 

Control and Prevention, National Institute for 

Occupational Safety and Health. DHHS (NIOSH) 

Publication No. 2008–139. 

21Franzblau A, Kazerooni EA, Goodsitt M [2009]. 

Digital X-ray imaging in pneumoconiosis screening: 

Future challenges for the NIOSH B Reader Program. 

In: NIOSH. The NIOSH B Reader Certification 

Program: Looking to the future. Cincinnati, OH: 

U.S. Department of Health and Human Services, 

Public Health Service, Centers for Disease Control 

and Prevention, National Institute for Occupational 

Safety and Health. DHHS (NIOSH) Publication No. 

2009–140. 

NIOSH [2008]. Application of the ILO 

International Classification of Radiographs of 

Pneumoconioses to Digital Chest Radiographic 

Images: A NIOSH Scientific Workshop. Cincinnati, 

OH: U.S. Department of Health and Human 

Services, Public Health Service, Centers for Disease 

Control and Prevention, National Institute for 

Occupational Safety and Health. DHHS (NIOSH) 

Publication No. 2008–139. 

22Schaefer-Prokop C, Neitzel U, Venema HW, 

Uffmann M, Prokop M [2008]. Digital chest 

radiography: An update on modern technology, 

dose containment and control of image quality. Eur 

Radiol 18(9):1818–1830. 

23Shepard SJ, Wang J, Flynn M, Gingold E, 

Goldman L, Krugh K, Leong DL, Mah E, Ogden K, 

Peck D, Samei E, Willis C [2009]. An exposure 

indicator for digital radiography. Report of AAPM 

Task Group 116. College Park, MD: American 

Association of Physicists in Medicine. AAPM 

Report No. 116. 

ACR Practice Guideline for diagnostic reference 

levels in medical X-ray imaging. Revised 2008 (Res. 

3). 

ACR Technical Standard for diagnostic medical 

physics performance monitoring of radiographic 

and fluoroscopic equipment. Revised 2006 (Res. 

29,16g,17). 

Facility Certification Document. The 

provision would also authorize NIOSH 

to suspend or withdraw a facility’s 

approval when warranted due to 

noncompliance with provisions of this 

rule. 

Proposed § 37.44(e) would require 

that facilities have a qualified medical 

physicist on site or available as a 

consultant. To minimize risks and 

assure standardized and predictable 

image quality from sophisticated digital 

radiography systems, facilities must 

have available highly trained 

individuals who are skilled in 

evaluating the equipment, methods, and 

procedures.18

Proposed § 37.44(f) would require that 

facilities document the findings by the 

medical physicist that each image 

acquisition system has met initial 

specifications and standards of the 

equipment manufacturer and 

performance testing. Since the 1980s, 

major advances have occurred in the 

practice of clinical radiology, most 

notably in the widespread adoption of 

digital technologies and systems for 

image acquisition, storage, transfer, and 

display.19 These digital technologies 

offer unique benefits for the 

identification and classification of 

pneumoconiosis, but due to the added 

complexities of digital radiography 

systems compared with film-screen 

radiology, these benefits may only be 

realized with proper implementation 

and utilization of the digital systems.20

To assure that the systems perform at 

the level required to meet the purposes 

of this Part, performance must be 

assessed by qualified individuals. 

Proposed § 37.44(g) would require 

facilities to implement a quality 

assurance program, and would 

incorporate by reference the standards 

set by the American Association of 

Physicists in Medicine. This provision 

continues the existing requirement for a 

quality control program, (§ 37.41(h)(9)) 

and further specifies professionally 

recommended procedures that must be 

an integral part of the operation of each 

digital radiography system. To ensure 

that radiologic examinations required 

under this Part are safe, reliable, and 

accurate, facilities that are approved to 

provide examinations using digital 

equipment must demonstrate that 

personnel, equipment, and procedures 

adhere to professionally accepted 

guidelines.21

Proposed § 37.44(g)(1) would require 

that facility approval applications 

include a comprehensive assessment by 

a qualified medical physicist within 12 

months prior to application. This 

paragraph would incorporate by 

reference guidelines established by the 

American Association of Physicists in 

Medicine. This provision continues the 

existing requirement (§ 37.42(c)). 

Proposed § 37.44(g)(2) would require 

the use of radiographic technique charts 

developed for the specific X-ray system 

and detector combination used at the 

facility. This section would incorporate 

by reference monitoring methods 

specified by the American Association 

of Physicists in Medicine, and radiation 

exposure reference levels specified by 

the American College of Radiology. 

Unlike film-screen radiology, digital 

radiography systems are susceptible to 

dose creep.22 Dose creep in this setting 

involves increasing examinee radiation 

exposures over time for similar types of 

examinations (e.g., chest radiographs) 

performed at a facility. The tendency to 

increase radiation exposures over time, 

beyond the levels necessary, results 

from the characteristics of digital image 

detectors (which provide excellent 

image quality when images are 

overexposed, but suboptimal image 

quality when underexposed) combined 

with the desire on the part of facilities 

to avoid repeat examinations. For this 

reason, as recommended by professional 

bodies, facilities utilizing digital 

systems for examinations under this 

Part are required to take additional steps 

to ensure optimal exposures, and to 

maintain records of annual monitoring 

and evaluation of representative 

radiation exposures over time, using 

standardized methods, metrics, and 

documentation.23

Proposed § 37.44(g)(3) would require 

that the performance of a digital 

radiography device be monitored 

according the recommendations of the 

medical physicist. Facilities would be 

required to maintain documentation 

upon the completion of quality 

assurance testing, and make it available 

to NIOSH for 5 years. NIOSH believes 

that retaining such records for 5 years is 

already standard business practice. This 

provision would also specify that 

certain tests are not required as a part 

of the quality assurance program for 

digital radiography systems (digital 

image acquisition systems in which the 

X-ray signals received by the image 

detector are converted to electronic 

signals without movable cassettes). This 

section provides more detailed guidance 

specific to the contemporary types of 

digital systems. 

Proposed § 37.44(g)(4) would require 

that facilities maintain documentation 

on the implementation and monitoring 

of policies and procedures required 

under this section. Documentation of 

key metrics is essential for facility 

management to assure adherence to 

internal policies, and provides a 

mechanism for NIOSH inspections to 

determine if the purposes of this Part 

are being met. 

Proposed § 37.44(h) would add the 

explicit requirement that facilities 

adhere to Federal laws to protect the 

confidentiality and privacy of coal 

miners participating in the program. 


tkelley on DSK3SPTVN1PROD with PROPOSALS4
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24 International Labour Office [2011]. Guidelines 

for the use of ILO International Classification of 

Pneumoconiosis, revised edition 2011). Geneva, 

Switzerland: International Labour Office. 

Occupational Safety and Health Series No. 22 (Rev. 

2011). 

25 Id. 

26Ruckley VA, Fernie JM, Chapman JS, Collings 

P, Davis JM, Douglas AN, Lamb D, and Seaton A 

[1984]. Comparison of radiographic appearances 

with associated pathology and lung dust content in 

a group of coalworkers. Br J Ind Med 41(4): 459– 

467. 

Cockcroft A, Lyons JP, Andersson N, and 

Saunders MJ [1983]. Prevalence and relation to 

underground exposure of radiological irregular 

opacities in South Wales coal workers with 

pneumoconiosis. Br J Ind Med 40(2): 169–172. 

27Flynn MJ [2008]. Image presentation: 

Implications of processing and display. In: NIOSH. 

Application of the ILO International Classification 

of Radiographs of Pneumoconioses to Digital Chest 

Radiographic Images: A NIOSH Scientific 

Workshop. Cincinnati, OH: U.S. Department of 

Health and Human Services, Public Health Service, 

Centers for Disease Control and Prevention, 

National Institute for Occupational Safety and 

Health. DHHS (NIOSH) Publication No. 2008–139. 

28Franzblau A, Kazerooni EA, Sen A, Goodsitt 

MM, Lee SY, Rosenman KD, Lockey JE, Meyer CA, 

Gillespie BW, Petsonk EL, Wang ML [2009]. 

Comparison of digital radiographs with film 

radiographs for the classification of 

pneumoconiosis. Acad Radiol 16(6):669–677. 

Sen A, Lee SY, Gillespie BW, Kazerooni EA, 

Goodsitt MM, Rosenman KD, Lockey JE, Meyer CA, 

Petsonk EL, Wang ML, Franzblau A [2010]. 

Comparison of reliability of classification for 

pneumoconiosis of film and digital radiographs: A 

modeling approach. Acad Radiol 17(4):511–519. 

Laney AS, Petsonk EL, Wolfe AL, Attfield MD 

[2009]. Comparison of storage phosphor computed 

radiography with conventional film-screen 

radiography in the recognition of pneumoconiosis. 

Eur Respir J, published ahead of print November 19, 

2009. 

NIOSH seeks to ensure that miners’ 

sensitive health information remains 

secure and is protected to the extent 

permitted by law. 

Section 37.45 Protection Against 

Radiation Emitted by Radiographic 

Equipment 

This proposed provision would 

require that radiographic equipment 

conform to applicable State, territorial, 

and Federal regulations. Where no State, 

territorial or Federal regulations apply, 

the section would incorporate by 

reference the recommendations of the 

NCRP. This provision is unchanged 

from the existing § 37.45, although 

references for the NCRP 

recommendations and contact 

information would be updated. 

Section 37.50 Interpreting and 

Classifying Chest Radiographs—Film 

Proposed procedures for classifying 

radiographs would be unchanged from 

the existing § 37.50, but for updating the 

requirement that images be interpreted 

and classified in accordance with the 

ILO International Classification of 

Radiographs for Pneumoconioses, 2011 

edition.24 The revised 2011 edition of 

the Guidelines for the use of the ILO 

International Classification of 

Radiographs of Pneumoconioses 

extends the applicability of the prior 

edition of the Classification to digital 

radiographic images of the chest. The 

proposed section would retain the 

existing provision that radiographs must 

be interpreted by an A or B Reader who 

has access to a complete set of the ILO 

Classification standard images, but 

would clarify that initial interpretations 

and notification of any findings other 

than that of pneumoconiosis shall be 

performed by a qualified physician. 

Provisions referring to view boxes 

would also be retained. Further, this 

section would be newly designated to 

apply only to film-screen radiographs. 

Section 37.51 Interpreting and 

Classifying Chest Radiographs—Digital 

Radiography Systems 

Proposed § 37.51(a) and (b) are similar 

to the first two provisions of § 37.50 for 

film radiographs, discussed above. 

Clinical readings of digital chest 

radiographs obtained under this Part 

must be performed by physicians who 

are qualified and licensed and who read 

chest radiographs in the normal course 

of practice. However, in NIOSH’s 

judgment, it would not be feasible to 

require that all physicians who provide 

the initial readings demonstrate 

proficiency with the ILO Classification 

of digital radiographs as specified in 

this Section. Such physicians are not 

sufficiently available to conduct these 

initial readings for coal miners in all 

locations in the United States. Thus the 

proposed rule specifies that a qualified 

and licensed physician who reads chest 

radiographs in the normal course of 

practice is qualified to provide 

interpretation and notification of any 

abnormal findings other than 

pneumoconiosis. 

The ILO has recently authorized the 

use of the ILO Classification for digital 

images and authorized a set of standard 

digital image files for use during 

classification. Paragraph § 37.51(b) 

would specify that the classification of 

digital images be done ‘‘in a manner 

consistent with the ILO International 

Classification of Radiographs of 

Pneumoconioses 2011.’’ 

Proposed § 37.51(c) would require 

radiograph interpreters to have available 

to them a complete set of NIOSHapproved standard digital chest 

radiographic images. The ILO 

classification system has provided a 

standardized approach to recognizing, 

describing, and quantifying 

abnormalities on the chest radiograph 

caused by dust.25 A set of standard film 

images is provided by the ILO and 

required to be used in side-by-side 

comparisons when classifying 

radiographs. These ILO standard images 

were originally obtained using filmscreen radiography, without application 

of edge enhancement or noise reduction 

software. Research using film-screen 

radiographs and classifications based 

upon the current ILO standard film 

radiographs has demonstrated that chest 

radiograph classification results 

correlate significantly with objective 

independent measures of dust exposure 

or lung dust content.26 To maintain the 

documented validity of the ILO 

classification system, the rule specifies 

that each reader compare digital images 

submitted under this regulation with 

NIOSH-approved digital versions of the 

standard images, and that no software 

modification of the standard images can 

be permitted. 

Proposed § 37.51(d) would require 

that viewing systems enable readers to 

display the chest image at full 

resolution, side-by-side with the 

selected NIOSH-approved standard 

image for comparison. This section 

would establish specifications for image 

display devices, including megapixels 

(MP) and bit depth; displays and 

associated graphics cards should meet 

the specifications of the current DICOM 

standard. This section would also set 

standards for display system luminance, 

relative noise, linearity, modulation 

transfer function (MTF), frequency, and 

glare by incorporating AAPM 

recommendations by reference. Finally, 

this section would require that displays 

be situated to minimize front surface 

glare. 

Visualization of the shadows on the 

chest radiograph caused by dust-related 

fibrosis is one of the most difficult 

challenges in medical diagnostic 

imaging. The viewing systems must 

provide sufficient luminance and gray 

scale depth to demonstrate the required 

subtle contrasts, and sufficient display 

size and density of pixels to reflect the 

resolution of the image file provided by 

the image detectors and required to 

visualize the fine linear fibrotic 

shadows.27 Research studies have 

demonstrated that reader recognition of 

pneumoconiosis on digital radiology 

systems can be equivalent to that 

achieved using film-screen radiology 

systems when appropriate system 

specifications and devices are 

employed.28 Additionally, adherence to 

the grayscale standard display function 

is required to assure that the appearance 


tkelley on DSK3SPTVN1PROD with PROPOSALS4
1370 Federal Register / Vol. 77, No. 5 / Monday, January 9, 2012 / Proposed Rules 

29Samei E, Ravin CE [2008]. Assuring image 

quality for classification of digital chest 

radiographs. In: NIOSH. Application of the ILO 

International Classification of Radiographs of 

Pneumoconioses to Digital Chest Radiographic 

Images: A NIOSH Scientific Workshop. Cincinnati, 

OH: U.S. Department of Health and Human 

Services, Public Health Service, Centers for Disease 

Control and Prevention, National Institute for 

Occupational Safety and Health. DHHS (NIOSH) 

Publication No. 2008–139. 

30 Id. 

31Samei E. Acquisition of digital chest images for 

pneumoconiosis classification: Methods, 

procedures, and hardware. In: NIOSH. Application 

of the ILO International Classification of 

Radiographs of Pneumoconioses to Digital Chest 

Radiographic Images: A NIOSH Scientific 

Workshop. Cincinnati, OH: U.S. Department of 

Health and Human Services, Public Health Service, 

Centers for Disease Control and Prevention, 

National Institute for Occupational Safety and 

Health. DHHS (NIOSH) Publication No. 2008–139. 

Franzblau A, Kazerooni EA, Sen A, Goodsitt MM, 

Lee SY, Rosenman KD, Lockey JE, Meyer CA, 

Gillespie BW, Petsonk EL, Wang ML [2009]. 

Comparison of digital radiographs with film 

radiographs for the classification of 

pneumoconiosis. Acad Radiol 16(6):669–677. 

Suganuma N, Murata K, Kusaka Y [2008]. CR and 

FPD DR chest radiographic image parameters for the 

pneumoconioses: The Japanese approach and 

experience. In: NIOSH. Application of the ILO 

International Classification of Radiographs of 

Pneumoconioses to digital chest radiographic 

images: A NIOSH Scientific Workshop. Cincinnati, 

OH: U.S. Department of Health and Human 

Services, Public Health Service, Centers for Disease 

Control and Prevention, National Institute for 

Occupational Safety and Health. DHHS (NIOSH) 

Publication No. 2008–139. 

Franzblau A, Kazerooni EA, Goodsitt M [2009]. 

Digital X-ray imaging in pneumoconiosis screening: 

Future challenges for the NIOSH B Reader Program. 

In: NIOSH. The NIOSH B Reader Certification 

Program: Looking to the future. Cincinnati, OH: 

U.S. Department of Health and Human Services, 

Public Health Service, Centers for Disease Control 

and Prevention, National Institute for Occupational 

Safety and Health. DHHS (NIOSH) Publication No. 

2009–140. 

32Morgan RH. Proficiency examination of 

physicians for classifying pneumoconiosis chest 

films. Am J Roentgenology 1979;132:803–08. 

Wagner GR, Attfield MD, Kennedy RD, Parker JE. 

The NIOSH B Reader Certification Program—An 

update report. Journal of Occupational Medicine. 

1992; 34:879–884. 

of the images is independent of the 

specific digital device used for display. 

Proposed § 37.51(d)(4) would also 

require that the measurements of pleural 

shadows and parenchymal opacities 

shall be taken using calibrated software 

measuring tools. This section would 

also require that, if possible, a record be 

made of the presentation state. Each 

individual reader is generally offered 

the option to select a specific setting 

that he or she judges to optimize the 

display characteristics of the chest 

radiographic image during the 

classification process; however, 

recording of the presentation states and 

annotations would be required (with 

compatible software) and would permit 

subsequent evaluation, using a 

Grayscale Standard Display Function 

(GSDF) compliant monitor, of the 

specific image that was displayed and 

interpreted by the reader who 

performed the classification.29

Proposed § 37.51(e) would require 

that quality control procedures for 

devices used to display images for 

classification comply with the 

recommendations of the American 

Association of Physicists in Medicine, 

which are incorporated by reference. 

Further, this section would require that 

if automatic quality assurance systems 

are used, regular visual inspection also 

be performed using test patterns 

recommended by the medical physicist. 

Periodic maintenance and assessment of 

the display devices is essential to 

document that performance continues to 

meet current professional 

recommendations.30 Because various 

automated systems may not detect all 

defects in digital display devices (such 

as distortion, dropout of pixels, or 

surface reflections), periodic visual 

inspections are also important to assure 

the display performance is adequate. 

Proposed § 37.51(f) would establish 

that the classification of digitallyacquired radiographs be based on the 

viewing of images displayed as soft 

copies, and not as hard copy printed 

transparencies. Further, proposed 

§ 37.51(g) would prohibit the use of 

digitized copies of film-screen acquired 

images. There is currently no sufficient 

scientific consensus regarding the 

equivalence of classifications performed 

using either 1) hard copies of digitallyacquired images or 2) digitized versions 

of film-screen radiographs in 

comparison to classifications performed 

using traditional film screen 

radiographic methods. For this reason, 

classifications based upon these two 

alternative approaches will not be 

accepted at this time.31

Section 37.52 Proficiency in the Use of 

Systems for Classifying the 

Pneumoconioses 

Proposed § 37.52(a) and (b), 

establishing the A and B Reader 

approval programs, would be modified 

from existing § 37.51 to make 

clarifications in the current 

requirements and update older 

terminology. Section 37.52(a)(3) would 

clarify that initial clinical 

interpretations and notification of 

findings other than pneumoconiosis 

under § 37.51(a) must be provided by a 

qualified physician who has all required 

licensure and privileges, and interprets 

chest radiographs in the normal course 

of practice. Proposed § 37.52(b)(1) 

would retain the requirement under 

existing § 37.51(b)(1) that B Reader 

approval prior to October 1, 1976 be 

terminated. 

Proposed § 37.52(b)(2) would retain 

the requirement under existing 

§ 37.51(b)(2) that physicians who desire 

to be B Readers demonstrate their 

proficiency in evaluating chest 

radiographs by taking an examination. 

The 6-hour initial certification 

examination was commissioned by 

NIOSH and developed under a contract 

through the American College of 

Radiology by the Department of 

Radiology and Radiological Science, 

Johns Hopkins School of Medicine. The 

test has been given about once a month 

by NIOSH since 1978. Beginning in 

1984, physicians who wish to maintain 

B reader status have been required to 

pass a 3-hour recertification 

examination every 4 years. Examinees 

for recertification who do not obtain a 

passing grade are permitted to take the 

initial 6-hour certification examination 

at the next available opportunity. 

Examinees who do not obtain a passing 

grade on the 6-hour certification 

examination must wait 6 months before 

they are eligible to sit again for the 

examination. The performance of the 

examination has been described in two 

manuscripts published in the peerreviewed literature.32

The examination will be based on 

either film or digital images. The 

existing provision would be modified to 

indicate that each physician desiring to 

take the digital version of the B Reader 

examination will be provided with a 

complete set of the NIOSH-approved 

digital standard reference radiographs. 

NIOSH intends to offer both the film 

and digital versions of the examination 

for a number of years. A satisfactory 

grade in either examination will qualify 

the physician to interpret both formats. 

NIOSH has not found that the format of 

the exam has any effect on performance, 

and finds no justification for requiring 

that a prospective B Reader take both 

versions of the exam. NIOSH welcomes 

public comment on the potential 

benefits as well as the disadvantages to 

requiring prospective readers to 

demonstrate competence in classifying 

both film and digital images. 

Finally, § 37.52(c) would require that 

physicians who wish to participate in 

the A and B Reader program familiarize 

themselves with the necessary 

components for attainment of reliable 

classification of chest radiographs for 

the pneumoconioses. The proposed 

requirement that prospective A and B 

Readers review NIOSH guidance on 

radiographic classification is included 

to ensure that each reader has studied 

recommended classification methods 


tkelley on DSK3SPTVN1PROD with PROPOSALS4
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33NIOSH [2011]. NIOSH Guideline: Application 

of Digital Radiography for the Detection and 

Classification of Pneumoconiosis. DHHS (NIOSH) 

Publication Number 2011–198. August 2011. 

http://www.cdc.gov/niosh/docs/2011-198/. 

Accessed November 16, 2011. 

and approaches. The referenced NIOSH 

guidance document is newly-developed 

and released; 33 approval as an A or B 

Reader requires this basic level of 

knowledge. 

Records pertaining to the provisions 

in § 37.52 are maintained by NIOSH 

under CDC/ATSDR Privacy Act System 

of Records Notice 0920–0001, Certifying 

Interpreting Physician File. 

Section 37.53 Method of Obtaining 

Definitive Interpretations 

Proposed § 37.53 would maintain the 

standards in existing § 37.52, which 

establishes that radiographs will be 

independently interpreted by an A 

Reader and B Reader, or two B Readers, 

whose classifications must be in 

agreement as defined in § 37.53(b); if 

sufficient agreement is lacking, NIOSH 

shall obtain a third interpretation. Text 

added to § 37.53(a) amends the existing 

provision to clarify procedures in the 

event that independent classifications 

from three B Readers do not 

demonstrate sufficient agreement. In 

that case, the final determination would 

be based upon the median (middle) 

classification of five interpretations 

derived from the three initial readings 

plus two other classifications from B 

Readers selected from the panel. This 

provision is intended to codify the 

process used to resolve disagreements 

among three or more B Readers. Text 

added to § 37.53(b) would clarify that 

substantial agreement is assessed by 

NIOSH after complete classifications are 

received on either a paper or electronic 

version of the standard 

Roentgenographic Interpretation Form 

(Form CDC/NIOSH (M)2.8). 

Section 37.54 Notification of 

Abnormal Radiographic Findings 

Proposed § 37.54, redesignated from 

§ 37.53, would be revised to update 

outdated terminology. The provision 

would also allow the first reader to 

communicate certain information 

directly to the miner, including 

abnormal findings other than 

pneumoconiosis. The notification 

procedure is intended to facilitate and 

expedite the process by which a miner 

is informed of potentially important 

medical problems and could seek 

treatment. 

Notification of important results to 

miners routinely occurs twice, 

providing a particularly robust 

notification process. The first 

notification is provided by the first 

physician to review a chest image in the 

community, who is required to provide 

documentation of miner notification to 

NIOSH. Subsequently, the image is sent 

to NIOSH and reviewed by NIOSH B 

readers. Within 60 days of completion 

of the physician readings, NIOSH will 

send a letter to each miner describing all 

findings in layman’s terminology, and 

recommending a specific course of 

action appropriate to the findings. 

Current regulations specify 60 days for 

receipt of the letters describing 

pneumoconiosis and any other findings. 

From many years of experience, NIOSH 

has found this time interval to be both 

appropriate and reasonable. Text for this 

letter is standardized, and has been used 

by CWHSP for many years. A booklet 

describing local medical and other 

resources and contact information will 

be included with each letter. 

Section 37.60 Submitting Required 

Chest Radiographs and Miner 

Identification Documents 

Proposed § 37.60 would be essentially 

unchanged from existing § 37.60, which 

establishes the protocol for submitting 

radiographs. Paragraph (a)(1) would also 

allow for the submission of image files 

for digital radiographs, and permit the 

use of either hard copy or electronic 

versions of the forms. We propose to 

strike the reference to a pre-employment 

physical examination from paragraph 

(d) to be consistent with the 

requirements of the Americans with 

Disabilities Act. 

Records pertaining to the provisions 

in § 37.60 are maintained by NIOSH 

under CDC/ATSDR Privacy Act System 

of Records Notice 0920–0149, Morbidity 

Studies in Coal Mining, Metal and NonMetal Mining and General Industry. 

Section 37.70 Review of 

Interpretations 

This section would be amended only 

to update terminology. Proposed 

§ 37.70(a) would retain the existing 

requirement that, in the situation in 

which a mine plan provides an A reader 

to perform the first reading of a miner’s 

radiograph, a miner may request, and 

NIOSH will obtain, an additional 

classification of his or her radiograph, 

performed by a B reader. Proposed 

§ 37.70(b) would retain the existing 

requirement that allows a mine operator 

who is directed by MSHA to transfer a 

miner to a less dusty atmosphere based 

on a recent examination to request that 

NIOSH review its findings. Terminology 

in both (a) and (b) would be updated. 

Section 37.80 Availability of Records 

for Radiographs 

Proposed § 37.80 would remain 

unchanged from the existing 

requirement. Terminology in this 

section would be updated. 

B. Subpart—Autopsies 

Section 37.200 Scope 

Proposed § 37.200 would remain 

unchanged from the existing 

explanation that provisions in this 

subpart establish conditions under 

which pathologists will be paid to 

conduct autopsies on deceased miners. 

Section 37.201 Definitions 

Proposed § 37.201 would retain the 

existing definitions for Secretary, miner, 

and pathologist, but would update 

‘‘ALFORD,’’ in the existing provision to 

‘‘NIOSH.’’ 

Section 37.202 Payment for Autopsy 

Proposed § 37.202 would retain the 

existing provision setting forth 

circumstances under which a 

pathologist may be paid by the Secretary 

for performing an autopsy. 

Section 37.203 Autopsy Specifications 

Proposed § 37.203 would retain the 

existing standards establishing the 

manner in which autopsies are 

conducted. 

Section 37.204 Procedure for 

Obtaining Payment 

Proposed § 37.204 would retain the 

existing procedure for submitting a 

claim for payment to NIOSH (‘‘NIOSH’’ 

would be updated, replacing 

‘‘ALFORD’’). 

IV. Regulatory Assessment 

Requirements 

A. Executive Order 12866 and Executive 

Order 13563 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). E.O. 13563 emphasizes the 

importance of quantifying both costs 

and benefits, of reducing costs, of 

harmonizing rules, and of promoting 

flexibility. 

This proposed rule is being treated as 

a ‘‘significant’’ action under E.O. 12866. 

It provides for the use of digital 

radiography systems in the Coal 

Workers’ Health Surveillance Program 

administered by NIOSH under 42 CFR 


tkelley on DSK3SPTVN1PROD with PROPOSALS4
1372 Federal Register / Vol. 77, No. 5 / Monday, January 9, 2012 / Proposed Rules 

34U.S. Department of Labor, Mine Safety and 

Health Administration. Mining Industry Accident, 

Injuries, Employment, and Production Data— 

Address & Employment Self-Extracting Files. 

http://www.msha.gov/stats/part50/p50y2k/ 

aetable.htm. Accessed July 7, 2011. 

part 37, in cooperation with coal mine 

operators, to monitor and protect the 

health of U.S. coal miners, particularly 

for the prevention of CWP. The current 

regulations at 42 CFR part 37 only allow 

for the use of film-screen radiography 

systems in this program. The addition of 

digital X-ray standards in part 37 would 

not require mine operators to change 

their plans to accommodate digital 

radiographs, but it is expected to 

substantially increase the amount of 

access miners will have to radiograph 

facilities because the use of film-screen 

radiography is declining markedly 

throughout the United States and 

specifically in areas where coal mining 

is located and where coal miners live. 

In fact, many clinics participating in the 

Program have indicated that they are 

maintaining their outdated X-ray film 

capabilities only because of Program 

requirements, and that they intend to 

switch to digital radiography when 

NIOSH allows its use by promulgating 

the rule proposed here. In general, most 

health care facilities have abandoned 

the use of film-based X-rays. 

Mammography was the last mainstream 

radiology procedure that required use of 

film; many facilities made the final 

switch to digital several years ago when 

digital mammography systems became 

available. 

Increased access to radiograph 

facilities that offer digital X-rays is 

expected to result in cost savings to coal 

miners because they will not have to 

drive as far to visit a suitable clinic. 

Digital radiographs are more costeffective than their film-based 

counterparts because they do not 

require costly chemical processing, they 

eliminate the need for a separate device 

to develop the image, and they avoid 

costs associated with managing and 

archiving hard-copy images. Over the 

past 5 years approximately 100 clinics 

have submitted film-screen radiographs 

to CWHSP. NIOSH queried several 

clinics on the costs associated with filmscreen radiography, including 

equipment maintenance, chemicals, 

film, and processing. Based on the 

responses, NIOSH believes that the cost 

to facilities of maintaining film X-ray 

technology to provide radiographs for 

approximately 2,500 coal miners is 

between $7,000 and $15,000 per clinic 

per year. Because NIOSH expects that 

most facilities participating in the 

Program will switch entirely to digital 

radiography when this rule is 

promulgated, we estimate a one-time 

cost savings to facilities that currently 

provide both film and digital 

radiographs of between $700,000 and 

$1,500,000 after they have discontinued 

the use of film radiographs. Although 

this rule does not require any facility to 

upgrade to digital technology, facilities 

that choose to do so will necessarily 

incur costs associated with its 

acquisition. NIOSH invites public 

comment on these estimates. 

The proposed rule would not require 

any radiography facility to perform 

digital radiographs for this NIOSH 

program. Facilities may continue to 

perform film-screen radiography under 

the current requirements of Part 37 

applicable to film-screen radiography, 

which would not be substantially 

changed by this proposed rule. 

The proposed provisions for using the 

DICOM standard and incorporating by 

reference standard best practices for 

digital radiography used in lung 

imaging ensure that the proposed 

requirements reflect standard practice 

and technology. For these reasons, the 

rule provisions allowing for the use of 

digital radiography and specifying 

equipment and practice parameters 

would not impose any additional costs 

on coal mine operators who provide for 

their miners’ participation in this 

program nor on the radiography 

facilities that serve the participating 

coal miners. 

The proposed rule would establish a 

new requirement for coal mine 

operators to provide to NIOSH a roster 

of current miners as proposed under 

§ 37.4(a)(3). The provision of this roster 

to NIOSH is current practice by almost 

all of the approximately 500 U.S. 

underground coal mine operators; 

therefore codifying this practice in 

regulation will not result in any 

additional cost to mine operators. For 

these reasons, the proposed rule is not 

considered economically significant, as 

defined in § 3(f)(1) of E.O. 12866. 

The rule is consistent with the 

requirements of 42 U.S.C. 7384n(c). The 

rule does not interfere with State, local, 

or tribal governments in the exercise of 

their governmental functions. 

B. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA), 

5 U.S.C. 601 et seq., requires each 

agency to consider the potential impact 

of its regulations on small entities 

including small businesses, small 

governmental units, and small not-forprofit organizations. This rule would 

establish standards for the delivery of 

digitally-acquired chest radiographs for 

underground coal miners. It would not 

impose any new requirements on small 

radiographic facilities that participate in 

the Coal Workers’ Health Surveillance 

Program administered by NIOSH under 

42 CFR part 37. These facilities may 

continue to exclusively use film-screen 

technology for radiography under 

provisions that would be essentially 

unchanged by this rulemaking. The rule 

would benefit these facilities by 

allowing and facilitating their transition 

to digital radiography for the purposes 

of this program. In this respect, the 

reliance in the proposal on the DICOM 

standards, standard technology, and 

current best practices for lung imaging 

radiography ensure that the rule is 

consistent with current medical 

practices in digital radiography. It 

should also be noted that if this 

standard permits some facilities to 

switch entirely to digital imaging, rather 

than maintaining two duplicate 

technologies, the facilities may be able 

to achieve savings in radiography 

operating costs, as discussed in the 

Executive Orders 12866 and 13563 

analysis above. The proposed standard 

would also introduce a substantial 

benefit in allowing the participation in 

the program of radiography facilities 

that solely use digital radiography; such 

facilities currently are prohibited from 

participation due to the current lack of 

digital radiography standards for the 

program under part 37. 

This proposed rule should increase 

access to medical facilities for small and 

larger coal mine operators, since many 

medical facilities exclusively use digital 

radiography or are transitioning to this 

technology. The rule may also decrease 

the cost to coal mine operators of 

providing X-ray screenings to miners. 

Lower cost is likely to be one of the 

factors in the trend among radiography 

facilities to adopt or switch entirely to 

digital radiography. In any event, 

allowing and facilitating the provision 

of digital radiography under part 37 

would impose no new costs on small 

coal mine operators. 

The proposed rule would establish a 

new requirement for coal mine 

operators to provide to NIOSH a roster 

of current miners as proposed under 

§ 37.4(a)(3). The provision of this roster 

to NIOSH is current practice by almost 

all coal mine operators. NIOSH 

estimates that, of 488 underground coal 

mines that can be considered small as 

of the first quarter of 2011,34 130 coal 

mine plans are submitted to the Agency 

annually. NIOSH further estimates that 

a clerical worker spends 0.5 hours per 

year preparing the roster. According to 

the Bureau of Labor Statistics, the 

average salary of a coal mine clerical 

worker is $17.38/hour; NIOSH estimates 

the annual cost for an individual coal 


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mine operator to supply a roster to 

NIOSH is approximately $9 and the 

total cost to all coal mines combined 

amounts to approximately $1170 

annually. In NIOSH’s judgment, this $9 

cost would not be significant for any 

coal mine operator. Therefore, a 

regulatory flexibility analysis as 

provided for under the RFA is not 

required. NIOSH certifies that this rule 

will not have a significant economic 

impact on a substantial number of small 

entities within the meaning of the RFA. 

C. Paperwork Reduction Act 

The Paperwork Reduction Act, 

44 U.S.C. 3501 et seq., requires an 

agency to invite public comment on, 

and to obtain OMB approval of, any 

regulation that requires 10 or more 

people to report information to the 

agency or to keep certain records. This 

proposed rule continues to impose the 

same information collection 

requirements as under the current rule, 

including the submission of the 

following forms: 

• Roentgenographic Interpretation 

Form [CDC/NIOSH (M)2.8] 

• Miner Identification Document 

[CDC/NIOSH (M)2.9] 

• Coal Mine Operator’s Plan [CDC/ 

NIOSH (M)2.10] 

• Facility Certification Document 

[CDC/NIOSH (M)2.11] 

• Interpreting Physician Certification 

Document [CDC/NIOSH (M)2.12] 

• Consent, Release, and History Form 

[CDC/NIOSH (M)2.6] 

These forms are approved by OMB for 

data collected under the CWHSP (OMB 

Control No. 0920–0020, exp. June 30, 

2014). 

The additional reporting burden 

associated with the Coal Mine 

Operator’s Plan which would require 

underground coal mine operators to 

submit a roster of current employees 

(§ 37.4(a)(3)), and the Facility 

Certification Document which would be 

required of participating digital 

radiography facilities (§ 37.44(a)(2)), are 

both accounted for in the OMB 

information collection approval 

referenced above. There is no additional 

recordkeeping burden associated with 

the quality assurance program 

referenced in § 37.44(g) because this 

provision reflects standard industry 

practice and does not impose any new 

recordkeeping requirements. 

Type of respondent Form name and No. Number of 

respondents 

Number of 

responses per 

respondent 

Hours/ 

response 

Response 

burden 

(in hrs) 

Physicians (B Readers) ............... Roentgenographic Interpretation 

Form—CDC/NIOSH (M) 2.8.

10,000 1 3/60 500 

Miners .......................................... Miner Identification Document—CDC/ 

NIOSH (M) 2.9.

5,000 1 20/60 1,667 

Coal Mine Operators ................... Coal Mine Operator’s Plan—CDC/ 

NIOSH (M) 2.10.

200 1 30/60 100 

Supervisors at X-ray Facilities ..... Facility Certification Document—CDC/ 

NIOSH (M) 2.11.

100 1 30/60 50 

Physicians (B Readers) ............... Interpreting Physician Certification Document—CDC/NIOSH (M) 2.12.300 1 10/60 50 

Spirometry Test—Coal Miners .... No form involved ................................... 2,500 1 20/60 833 

X-ray—Coal Miners ..................... No form involved ................................... 5,000 1 15/60 1250 

Pathologist ................................... (Invoice) ................................................. 50 1 5/60 4 

Pathologist ................................... (Final diagnosis) .................................... 50 1 5/60 4 

Next-of-Kin ................................... Consent, Release, and History Form— 

CDC.NIOSH (M) 2.6.

50 1 15/60 13 

Totals .................................... ................................................................ 23,250 ........................ ........................ 4,471 

D. Small Business Regulatory 

Enforcement Fairness Act 

As required by Congress under the 

Small Business Regulatory Enforcement 

Fairness Act of 1996 (5 U.S.C. 801 et 

seq.), the Department will report the 

promulgation of this rule to Congress 

prior to its effective date. The report 

will state that the Department has 

concluded that this rule is not a ‘‘major 

rule’’ because it is not likely to result in 

an annual effect on the economy of 

$100 million or more. 

E. Unfunded Mandates Reform Act of 

1995 

Title II of the Unfunded Mandates 

Reform Act of 1995 (2 U.S.C. 1531 et 

seq.) directs agencies to assess the 

effects of Federal regulatory actions on 

State, local, and tribal governments, and 

the private sector ‘‘other than to the 

extent that such regulations incorporate 

requirements specifically set forth in 

law.’’ For purposes of the Unfunded 

Mandates Reform Act, this rule does not 

include any Federal mandate that may 

result in increased annual expenditures 

in excess of $100 million by State, local 

or tribal governments in the aggregate, 

or by the private sector. 

F. Executive Order 12988 (Civil Justice) 

This rule has been drafted and 

reviewed in accordance with Executive 

Order 12988, ‘‘Civil Justice Reform,’’ 

and will not unduly burden the Federal 

court system. Chest radiograph 

interpretations that result in a finding of 

pneumoconiosis may be an element in 

claim processing and adjudication 

conducted by DOL’s Black Lung 

Compensation Program. This proposed 

rule would affect radiographs submitted 

to DOL for the purpose of reviewing and 

administering those claims. This rule 

has been reviewed carefully to eliminate 

drafting errors and ambiguities. 

G. Executive Order 13132 (Federalism) 

The Department has reviewed this 

rule in accordance with Executive Order 

13132 regarding federalism, and has 

determined that it does not have 

‘‘federalism implications.’’ The rule 

does 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.’’ 

H. Executive Order 13045 (Protection of 

Children From Environmental Health 

Risks and Safety Risks) 

In accordance with Executive Order 

13045, HHS has evaluated the 

environmental health and safety effects 

of this rule on children. HHS has 

determined that the rule would have no 

effect on children. 


tkelley on DSK3SPTVN1PROD with PROPOSALS4
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I. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

In accordance with Executive Order 

13211, HHS has evaluated the effects of 

this rule on energy supply, distribution 

or use, and has determined that the rule 

will not have a significant adverse 

effect. 

J. Plain Writing Act of 2010 

Under Public Law 111–274 (October 

13, 2010), executive Departments and 

Agencies are required to use plain 

language in documents that explain to 

the public how to comply with a 

requirement the Federal Government 

administers or enforces. HHS has 

attempted to use plain language in 

promulgating the proposed rule 

consistent with the Federal Plain 

Writing Act guidelines. 

V. Proposed Rule 

List of Subjects in 42 CFR Part 37 

Black lung benefits, Incorporation by 

reference, Lung diseases, Mine safety 

and health, Occupational safety and 

health, Pneumoconiosis, Respiratory 

and pulmonary diseases, Underground 

coal mining, Workers’ compensation, 

X-rays. 

Text of the Rule 

For the reasons discussed in the 

preamble, the Department of Health and 

Human Services proposes to amend 

42 CFR part 37 as follows: 

PART 37—SPECIFICATIONS FOR 

MEDICAL EXAMINATIONS OF 

UNDERGROUND COAL MINERS 

1. The authority citation for part 37 

continues to read as follows: 

Authority: Sec. 203, 83 Stat. 763 (30 U.S.C. 

843), unless otherwise noted. 

Subpart—Chest Radiographic 

Examinations 

2. Revise § 37.1 to read as follows: 

§ 37.1 Scope. 

The provisions of this subpart set 

forth the specifications for giving, 

interpreting, classifying, and submitting 

chest radiographs required by section 

203 of the Act to be given to 

underground coal miners and new 

miners. 

3. Revise § 37.2 to read as follows: 

§ 37.2 Definitions. 

Any term defined in the Federal Mine 

Safety and Health Act of 1977 and not 

defined below shall have the meaning 

given it in the Act. As used in this 

subpart: 

Act means the Federal Mine Safety 

and Health Act of 1977 (30 U.S.C. 801, 

et seq.). 

Chest radiograph means a single 

posteroanterior radiographic projection 

or radiograph of the chest at full 

inspiration recorded on either film or 

digital radiography systems. 

Convenient time and place with 

respect to the conduct of any 

examination under this subpart means 

that the examination must be given at a 

reasonable hour in the locality in which 

the miner resides or a location that is 

equally accessible to the miner. For 

example, examinations at the mine 

during, immediately preceding, or 

immediately following work and a ‘‘no 

appointment’’ examination at a medical 

facility in a community easily accessible 

to the residences of a majority of the 

miners working at the mine, shall be 

considered of equivalent convenience 

for purposes of this paragraph. 

Digital radiography systems, as used 

in this context, include both Digital 

Radiography (DR) and Computed 

Radiography (CR). 

(1) Computed radiography (CR) is the 

term for digital X-ray image acquisition 

systems that detect X-ray signals using 

a cassette-based photostimulable storage 

phosphor. Subsequently, the cassette is 

processed using a stimulating laser 

beam to convert the latent radiographic 

image to electronic signals which are 

then processed and stored so they can 

be displayed. 

(2) Digital radiography (DR) is the 

term used for digital X-ray image 

acquisition systems in which the X-ray 

signals received by the image detector 

are converted nearly instantaneously to 

electronic signals without movable 

cassettes. 

ILO Classification means the belowreferenced classification of radiographs 

of the pneumoconioses system devised 

by an international committee of the 

International Labour Office (ILO), 

including a complete set of standard 

film radiographs or digital chest image 

files available from the ILO or other set 

of chest image files accepted by NIOSH 

as equivalent. 

MSHA means the Mine Safety and 

Health Administration, Department of 

Labor. 

Miner means any individual 

including any coal mine construction 

worker who is working in or at any 

underground coal mine, but does not 

include any surface worker who does 

not have direct contact with 

underground coal mining or with coal 

processing operations. 

NIOSH means the National Institute 

for Occupational Safety and Health 

(NIOSH), located within the Centers for 

Disease Control and Prevention (CDC). 

Within NIOSH, the Division of 

Respiratory Disease Studies (DRDS), 

Box 4258, Morgantown, WV 26504, 

formerly called the Appalachian 

Laboratory for Occupational Safety and 

Health, is the organizational unit that 

has programmatic responsibility for the 

chest radiographic examination 

program. 

NIOSH representative means 

employees of CDC/NIOSH and 

employees of CDC contractors. 

Operator means any owner, lessee, or 

other person who operates, controls, or 

supervises an underground coal mine or 

any independent contractor performing 

services or construction at such mine. 

Panel of B Readers means the group 

of physicians that are currently 

approved by NIOSH as B Readers. 

Pre-placement physical examination 

means any medical examination which 

includes a chest radiographic 

examination given in accordance with 

the specifications of this Part to a person 

not previously employed by the same 

operator. Such examinations should be 

conducted consistent with applicable 

law, including the Americans with 

Disabilities Act of 1990, which provides 

that pre-placement examinations take 

place only after an offer of employment 

has been made and subject to certain 

restrictions (42 U.S.C. 12112(d)). 

Qualified medical physicist means an 

individual who is trained in evaluating 

the performance of radiographic 

equipment including radiation controls 

and facility quality assurance programs, 

and has the relevant current 

certification by a competent U.S. 

national board, or unrestricted license 

or approval from a U.S. state or territory. 

Radiographic technique chart means a 

table which specifies the types of 

cassette, intensifying screen, film or 

digital detector, grid, filter, and lists Xray machine settings (timing, kVp, mA) 

that enables the radiographer to select 

the correct settings based on the body 

habitus or the thickness of the chest 

tissue. 

Radiologic technologist means an 

individual who has met the 

requirements for privileges to perform 

general radiographic procedures and for 

competence in using the equipment and 

software employed by the examining 

facility to obtain chest images as 

specified by the state or territory and 

examining facility in which such 

services are provided. Optimally, such 

an individual will have completed a 

formal training program in radiography 

leading to a certificate, an associate 

degree, or a bachelor’s degree and 

participated in the voluntary initial 

certification and annual renewal of 


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registration for radiologic technologists 

offered by the American Registry of 

Radiologic Technologists. 

Secretary means the Secretary of 

Health and Human Services and any 

other officer or employee of the 

Department of Health and Human 

Services to whom the authority 

involved may be delegated. 

Soft copy means the image of a coal 

miner’s chest radiograph acquired using 

a digital radiography system, viewed at 

the full resolution of the image 

acquisition system using an electronic 

medical image display device. 

4. Revise § 37.3 to read as follows: 

§ 37.3 Chest radiographs required for 

miners. 

(a) Voluntary examinations. Every 

operator shall provide to each miner 

who is employed in or at any of its 

underground coal mines and who was 

employed in underground coal mining 

prior to December 30, 1969, or who has 

completed the required examinations 

under § 37.3(b) an opportunity for a 

chest radiograph in accordance with 

this subpart: 

(1) Following August 1, 1978 NIOSH 

will notify the operator of each 

underground coal mine of a period 

within which the operator may provide 

examinations to each miner employed at 

its coal mine. The period shall begin no 

sooner than the effective date of these 

regulations and end no later than a date 

specified by NIOSH separately for each 

coal mine. The termination date of the 

period will be approximately 5 years 

from the date of the first examination 

which was made on a miner employed 

by the operator in its coal mine under 

the former regulations of this subpart 

adopted July 27, 1973. Within the 

period specified by NIOSH for each 

mine, the operator may select a 6-month 

period within which to provide 

examinations in accordance with a plan 

approved under § 37.5. 

Example: NIOSH finds that between July 

27, 1973, and March 31, 1975, the first 

radiograph for a miner who was employed at 

mine Y and who was employed in 

underground coal mining prior to December 

30, 1969, was made on January 1, 1974. 

NIOSH will notify the operator of mine Y 

that the operator may select and designate on 

its plan a 6-month period within which to 

offer its examinations to its miners employed 

at mine Y. The 6-month period shall be 

scheduled between August 1, 1978 and 

January 1, 1979 (5 years after January 1, 

1974). 

(2) For all future voluntary 

examinations, NIOSH will notify the 

operator of each underground coal mine 

when sufficient time has elapsed since 

the end of the previous 6-month period 

of examinations. NIOSH will specify to 

the operator of each mine a period 

within which the operator may provide 

examinations to its miners employed at 

its coal mine. The period shall begin no 

sooner than 31⁄2 years and end no later 

than 41⁄2 years subsequent to the ending 

date of the previous 6-month period 

specified for a coal mine either by the 

operator on an approved plan or by 

NIOSH if the operator did not submit an 

approved plan. Within the period 

specified by NIOSH for each mine, the 

operator may select a 6-month period 

within which to provide examinations 

in accordance with a plan approved 

under § 37.5. 

Example: NIOSH finds that examinations 

were previously provided to miners 

employed at mine Y in a 6-month period 

from July 1, 1979, to December 31, 1979. 

NIOSH notifies the operator at least 3 months 

before July 1, 1983 (31⁄2 years after December 

31, 1979) that the operator may select and 

designate on its plan the next 6-month period 

within which to offer examinations to its 

miners employed at mine Y. The 6-month 

period shall be scheduled between July 1, 

1983, and July 1, 1984 (between 31⁄2 and 41⁄2

years after December 31, 1979). 

(3) Within either the next or future 

period(s) specified by NIOSH to the 

operator for each of its coal mines, the 

operator of the coal mine may select a 

different 6-month period for each of its 

mines within which to offer 

examinations. In the event the operator 

does not submit an approved plan, 

NIOSH will specify a 6-month period to 

the operator within which miners shall 

have the opportunity for examinations. 

(b) Mandatory examinations. Every 

operator shall provide to each miner 

who begins working in or at a coal mine 

for the first time after December 30, 

1969: 

(1) An initial chest radiograph, as 

soon as possible, but in no event later 

than 6 months after commencement of 

employment. An initial chest 

radiograph given to a miner according to 

former regulations for this subpart prior 

to August 1, 1978 will also be 

considered as fulfilling this 

requirement. 

(2) A second chest radiograph, in 

accordance with this subpart, 3 years 

following the initial examination if the 

miner is still engaged in underground 

coal mining. A second radiograph given 

to a miner according to former 

regulations under this subpart prior to 

August 1, 1978 will be considered as 

fulfilling this requirement. 

(3) A third chest radiograph 2 years 

following the second chest radiograph if 

the miner is still engaged in 

underground coal mining and if the 

second radiograph shows evidence of 

category 1 (1/0, 1/1, 1/2), category 2 (2/ 

1, 2/2, 2/3), category 3 (3/2, 3/3, 3/+) 

simple pneumoconioses, or complicated 

pneumoconioses (ILO Classification). 

(c) NIOSH will notify the miner when 

he or she is due to receive the second 

or third mandatory examination under 

(b) of this section. Similarly, NIOSH 

will notify the coal mine operator when 

the miner is to be given a second 

examination. The operator will be 

notified concerning a miner’s third 

examination only with the miner’s 

written consent, and the notice to the 

operator shall not state the medical 

reason for the examination nor that it is 

the third examination in the series. If 

the miner is notified by NIOSH that the 

third mandatory examination is due and 

the operator is not so notified, 

availability of the radiographic 

examination under the Coal Mine 

Operator’s Plan (Form CDC/NIOSH 

(M)2.10) shall constitute the operator’s 

compliance with the requirement to 

provide a third mandatory examination 

even if the miner refuses to take the 

examination. 

(d) The opportunity for chest 

radiographs to be available by an 

operator for purposes of this subpart 

shall be provided in accordance with a 

plan which has been submitted and 

approved in accordance with this 

subpart. 

5. Amend § 37.4 by revising 

paragraphs (a) introductory text, (a)(3), 

(a)(4), (a)(6), (a)(7), and (d) through (f) to 

read as follows: 

§ 37.4 Plans for chest radiographic 

examinations. 

(a) Every plan for chest radiographic 

examinations of miners shall be 

submitted on the Coal Mine Operator’s 

Plan form (Form CDC/NIOSH (M)2.10) 

to NIOSH within 120 calendar days after 

August 1, 1978. In the case of a person 

who after August 1, 1978, becomes an 

operator of a mine for which no plan 

has been approved, that person shall 

submit a plan within 60 days after such 

event occurs. A separate plan shall be 

submitted by the operator and by each 

construction contractor for each 

underground coal mine which has a 

MSHA identification number. The plan 

shall include: 

* * * * * 

(3) The proposed beginning and 

ending date of the 6-month period for 

voluntary examinations (see § 37.3(a)), 

the estimated number of miners to be 

given or offered examinations during 

the 6-month period under the plan, and 

a roster specifying the names and 

current home mailing addresses of each 

miner covered by the plan; 

(4) The name and location of the 

approved X-ray facility or facilities, and 


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the approximate date(s) and time(s) of 

day during which the radiographs will 

be given to miners to enable a 

determination of whether the 

examinations will be conducted at a 

convenient time and place; 

* * * * * 

(6) The name and address of the A or 

B Reader who will interpret and classify 

the chest radiographs. In the event a 

plan lists an approved facility with a 

digital radiography system, the name 

and address of the physician(s) who will 

perform the initial clinical 

interpretation. 

(7) Assurances that: 

(i) The operator will not solicit a 

physician’s radiographic or other 

findings concerning any miner 

employed by the operator, 

(ii) Instructions have been given to the 

person(s) giving the examinations that 

duplicate radiographs or copies of 

radiographs (including, for digital 

radiographs, copies of electronic files) 

will not be made, and to the extent that 

it is technically feasible for the imaging 

system used, digital radiographs and all 

related digital files shall be permanently 

deleted from the facility records or 

rendered permanently inaccessible 

following the confirmed transfer of such 

data to NIOSH, and that (except as may 

be necessary for the purpose of this 

subpart) the physician’s radiographic 

and other findings, as well as the 

occupational history information 

obtained from a miner will not be 

disclosed in a manner that would 

permit identification of the individual 

with their information, and 

(iii) The radiographic examinations 

will be made at no charge to the miner. 

* * * * * 

(d) The operator shall advise NIOSH 

of any change in its plan. Each change 

in an approved plan is subject to the 

same review and approval as the 

originally approved plan. 

(e) The operator shall promptly 

display in a visible location on the 

bulletin board at the mine its proposed 

plan or proposed change in plan when 

it is submitted to NIOSH. The proposed 

plan or change in plan shall remain 

posted in a visible location on the 

bulletin board until NIOSH either grants 

or denies approval of it at which time 

the approved plan or denial of approval 

shall be permanently posted. In the case 

of an operator who is a construction 

contractor and who does not have a 

bulletin board, the construction 

contractor must otherwise notify its 

employees of the examination 

arrangements. Upon request, the 

contractor must show NIOSH written 

evidence that its employees have been 

notified. 

(f) Upon notification from NIOSH that 

sufficient time has elapsed since the 

previous period of examinations, the 

operator will resubmit its plan for each 

of its coal mines to NIOSH for approval 

for the next period of examinations (see 

§ 37.3(a)(2)). The plan shall include the 

proposed beginning and ending dates of 

the next period of examinations and all 

information required by paragraph (a) of 

this section. 

6. Revise § 37.5 to read as follows: 

§ 37.5 Approval of plans. 

(a) If, after review of any plan 

submitted pursuant to this subpart, the 

Secretary determines that the action to 

be taken under the plan by the operator 

meets the specifications of this subpart 

and will effectively achieve its purpose, 

the Secretary will approve the plan and 

notify the operator(s) submitting the 

plan of the approval. Approval may be 

conditioned upon such terms as the 

Secretary deems necessary to carry out 

the purpose of section 203 of the Act. 

(b) Where the Secretary has reason to 

believe that he or she will deny 

approval of a plan the Secretary will, 

prior to the denial, give reasonable 

notice in writing to the operator(s) of an 

opportunity to amend the plan. The 

notice shall specify the ground upon 

which approval is proposed to be 

denied. 

(c) If a plan is denied approval, the 

Secretary shall advise the operator(s) in 

writing of the reasons for the denial. 

7. Amend § 37.6 by revising 

paragraphs (a) and (d) to read as follows: 

§ 37.6 Chest radiographic examinations 

conducted by the Secretary. 

(a) The Secretary will give chest 

radiographs or make arrangements with 

an appropriate person, agency, or 

institution to give the chest radiographs 

and with A or B Readers to interpret the 

radiographs required under this subpart 

in the locality where the miner resides, 

at the mine, or at a medical facility 

easily accessible to a mining community 

or mining communities, under the 

following circumstances: 

* * * * * 

(d) Operators of mines selected by 

NIOSH to participate in the National 

Study of Coal Workers’ Pneumoconiosis 

(an epidemiological study of respiratory 

diseases in coal miners) and who agree 

to cooperate will have all their miners 

afforded the opportunity to have a chest 

radiograph required hereunder at no 

cost to the operator. For future 

examinations and for mandatory 

examinations each participating 

operator shall submit an approvable 

plan. 

8. Amend § 37.7 by revising paragraph 

(a) to read as follows: 

§ 37.7 Transfer of affected miner to less 

dusty area. 

(a) Any miner who, in the judgment 

of the Secretary based upon the 

interpretation of one or more of the 

miner’s chest radiographs, shows 

category 1 (1/0, 1/1, 1/2), category 2 (2/ 

1, 2/2, 2/3), or category 3 (3/2, 3/3, 3/ 

+) simple pneumoconioses, or 

complicated pneumoconioses (ILO 

Classification) shall be afforded the 

option of transferring from his or her 

position to another position in an area 

of the mine where the concentration of 

respirable dust in the mine atmosphere 

is not more than 50 percent of the 

maximum respirable dust concentration 

permitted by MSHA, or if such level is 

not attainable in the mine, to a position 

in the mine where the concentration of 

respirable dust is the lowest attainable 

below the maximum respirable dust 

concentration permitted by MSHA. 

* * * * * 

9. Revise § 37.8 to read as follows: 

§ 37.8 Radiographic examination at 

miner’s expense. 

Any miner who wishes to obtain an 

examination at the miner’s own expense 

at an approved facility and to have the 

complete examination submitted to 

NIOSH may do so, provided that the 

examination is made no sooner than 6 

months after the most recent 

examination of the miner submitted to 

NIOSH. NIOSH will provide an 

interpretation and report of the 

examinations made at the miner’s 

expense in the same manner as if it were 

submitted under an operator’s plan. Any 

change in the miner’s transfer rights 

under the act which may result from 

this examination will be subject to the 

terms of § 37.7. 

10. Revise § 37.20 to read as follows: 

§ 37.20 Miner identification document. 

As part of the radiographic 

examination, a Miner Identification 

Document (Form CDC/NIOSH (M)2.9) 

which includes an occupational history 

questionnaire shall be completed for 

each miner at the facility where the 

radiograph is made at the same time the 

chest radiograph required by this 

subpart is given. 

11. Revise the undesignated center 

heading and § 37.40 to read as follows: 


tkelley on DSK3SPTVN1PROD with PROPOSALS4
Federal Register / Vol. 77, No. 5 / Monday, January 9, 2012 / Proposed Rules 1377 

Specifications for Performing Chest 

Radiographic Examinations 

§ 37.40 General provisions. 

(a) The chest radiographic 

examination shall be given at a 

convenient time and place. 

(b) The chest radiographic 

examination consists of the chest 

radiograph, and a complete 

Roentgenographic Interpretation Form 

(Form CDC/NIOSH (M)2.8), and Miner 

Identification Document (Form CDC/ 

NIOSH (M)2.9). 

(c) A radiographic examination shall 

be made in a facility approved in 

accordance with § 37.43 or § 37.44 by or 

under the supervision of a physician 

who makes chest radiographs in the 

normal course of practice and who has 

demonstrated ability to make chest 

radiographs of a quality to best ascertain 

the presence of pneumoconiosis. 

12. Amend § 37.41 as follows: 

a. Revise the section heading. 

b. Redesignate paragraphs (a) and (b) 

as paragraphs (b) and (a) respectively. 

c. Redesignate paragraphs (c) through 

(m) as (d) through (n). 

d. Add new paragraph (c). 

e. Revise newly designated 

paragraphs (a), (b), (d) through (h), (i) 

introductory text, (i)(1) through (i)(3), 

(i)(7), (j)(2), (k), (m), and (n) to read as 

follows: 

§ 37.41 Chest radiograph specifications— 

film. 

(a) Miners shall be disrobed from the 

waist up at the time the radiograph is 

given. The facility shall provide a 

dressing area and for those miners who 

wish to use one, the facility shall 

provide a clean gown. Facilities shall be 

heated to a comfortable temperature. 

(b) Every chest radiograph shall be a 

single posteroanterior projection at full 

inspiration on a film being no less than 

14 by 17 inches and no greater than 16 

by 17 inches. The film and cassette shall 

be capable of being positioned both 

vertically and horizontally so that the 

chest radiograph will include both 

apices and costophrenic angles. If a 

miner is too large to permit the above 

requirements, then the projection shall 

include both apices with minimum loss 

of the costophrenic angle. 

(c) Chest radiographs shall be 

performed by a radiologic technologist. 

(d) Radiographs shall be made only 

with a diagnostic X-ray machine having 

a rotating anode tube with a maximum 

of a 2 mm source (focal spot). 

(e) Except as provided in paragraph 

(e) of this section, radiographs shall be 

made with units having generators 

which comply with the following: 

(1) The generators of existing 

radiographic units acquired by the 

examining facility prior to July 27, 1973, 

shall have a minimum rating of 200 mA 

at 100 kVp; 

(2) Generators of units acquired 

subsequent to that date shall have a 

minimum rating of 300 mA at 125 kVp. 

(f) Radiographs made with batterypowered mobile or portable equipment 

shall be made with units having a 

minimum rating of 100 mA at 110 kVp 

at 500 Hz, or of 200 mA at 110 kVp at 

60 Hz. 

(g) Capacitor discharge and field 

emission units may be used if the model 

of such units is approved by NIOSH for 

quality, performance, and safety. NIOSH 

will consider such units for approval 

when listed by a facility seeking 

approval under § 37.43 or § 37.44 of this 

subpart. 

(h) Radiographs shall be given only 

with equipment having a beam-limiting 

device which does not cause large 

unexposed boundaries. The beam 

limiting device shall provide 

rectangular collimation and shall be of 

the type described in 21 CFR 

1020.31(d), (e), (f), and (g). The use of 

such a device shall be discernible from 

an examination of the radiograph. 

(i) To ensure high quality chest 

radiographs: 

(1) The maximum exposure time shall 

not exceed 50 milliseconds except that 

with single phase units with a rating 

less than 300 mA at 125 kVp and 

subjects with chests over 28 cm 

posteroanterior, the exposure may be 

increased to not more than 100 

milliseconds; 

(2) The source or focal spot to film 

distance shall be at least 6 feet; 

(3) Medium speed film and medium 

speed intensifying screens are 

recommended. However, any filmscreen combination, the rated ‘‘speed’’ 

of which is at least 100 and does not 

exceed 300, which produces 

radiographs with spatial resolution, 

contrast, latitude and quantum mottle 

similar to those of systems designated as 

‘‘medium speed’’ may be employed; 

* * * * * 

(7) A suitable grid or other means of 

reducing scattered radiation shall be 

used; 

* * * * * 

(j) * * * 

(2) If mineral or other impurities in 

the processing water introduce 

difficulty in obtaining a high-quality 

radiograph, a suitable filter or 

purification system shall be used. 

(k) Before the miner is advised that 

the examination is concluded, the 

radiograph shall be processed and 

inspected and accepted for quality by 

the physician, or if the physician is not 

available, acceptance may be made by 

the radiologic technologist. In a case of 

a substandard radiograph, another shall 

be immediately made. All substandard 

radiographs shall be clearly marked as 

rejected and promptly sent to NIOSH for 

disposal. 

* * * * * 

(m) A test object may be required on 

each radiograph for an objective 

evaluation of film quality at the 

discretion of NIOSH. 

(n) Each radiograph made hereunder 

shall be permanently and legibly 

marked with the name and address or 

NIOSH approval number of the facility 

at which it is made, the social security 

number of the miner, and the date of the 

radiograph. No other identifying 

markings shall be recorded on the 

radiograph. 

§§ 37.42 and 37.43 [Redesignated] 

13a. Redesignate §§ 37.42 and 37.43 

as §§ 37.43 and 37.45 respectively. 

13b. Add new § 37.42 to read as 

follows: 

§ 37.42 Chest radiograph specifications— 

digital radiography systems. 

(a) Miners shall be disrobed from the 

waist up at the time the radiograph is 

given. The facility shall provide a 

private dressing area and for those 

miners who wish to use one, the facility 

shall provide a clean gown. Facilities 

shall be heated to a comfortable 

temperature. 

(b) Every digital chest radiograph 

taken as required under this regulation 

shall be a single posteroanterior 

projection at full inspiration on a digital 

detector being no less than 35 by 43 cm 

(14 by 17 if measured in inches) and no 

greater than 41 by 43 cm (16 by 17 

inches). The imaging plate shall have a 

maximum pixel pitch of 200mm, and a 

minimum matrix size of 5 megapixels 

(for 35 by 43 cm), with a minimum bit 

depth of 10. Spatial resolution shall be 

at least 2.5 line pairs per millimeter. 

The storage phosphor cassette or digital 

image detector shall be positioned either 

vertically or horizontally so that the 

image includes the apices and 

costophrenic angles of both right and 

left lungs. If the detector cannot include 

the apices and costophrenic angles of 

both lungs as described, then two side 

by side images can be obtained which 

together include the apices and the 

costophrenic angles of both right and 

left lungs. 

(c) Chest radiographs shall be given 

by a radiologic technologist. 

(d) Radiographs shall be made with a 

diagnostic X-ray machine with a 

maximum of a 2 mm source (focal spot). 


tkelley on DSK3SPTVN1PROD with PROPOSALS4
1378 Federal Register / Vol. 77, No. 5 / Monday, January 9, 2012 / Proposed Rules 

(e) Radiographs shall be made with 

units having generators which have a 

minimum rating of 300 mA at 125 kVp. 

Exposure kilovoltage shall be at least the 

minimum as recommended by the 

manufacturer for chest radiography. 

(f) An electric power supply shall be 

used which complies with the voltage, 

current, and regulation specified by the 

manufacturer of the machine. If the 

manufacturer or installer of the 

radiographic equipment recommends 

equipment for control of electrical 

power fluctuations, such equipment 

shall be used as recommended. 

(g) Radiographs shall be obtained only 

with equipment having a beam-limiting 

device that does not cause large 

unexposed boundaries. The beam 

limiting device shall provide 

rectangular collimation. Electronic postimage acquisition ‘‘shutters’’ available 

on some CR and DR systems that limit 

the size of the final image and that 

simulate collimator limits shall not be 

used. The use and effect of the beam 

limiting device shall be discernible on 

the resulting image. 

(h) Radiographic technique charts 

shall be used that are developed 

specifically for the X-ray system and 

detector combinations used, indicating 

exposure parameters by anatomic 

measurements. 

(1) If automated exposure control 

devices are used, performance shall be 

documented by a medical physicist 

utilizing the image capture systems and 

exposure parameters used at the facility 

for chest imaging, using methods 

recommended by the American 

Association of Physicists in Medicine in 

AAPM Report No. 74, Quality Control in 

Diagnostic Radiology, Report of Task 

Group #12, Diagnostic X-Ray Imaging 

Committee, published by Medical 

Physics Publishing for AAPM, July 

2002, pages 17–18, and in AAPM Report 

No. 14, Performance Specifications and 

Acceptance Testing for X-Ray 

Generators and Automatic Exposure 

Control Devices, Report of the 

Diagnostic X-Ray Imaging Committee 

Task Group on Performance 

Specifications and Acceptance Testing 

for X-Ray Generators and Automatic 

Exposure Control Devices, published by 

the American Institute of Physics for 

AAPM, January 1985, pages 61–62. 

These reports are incorporated by 

reference. 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. You may 

obtain a copy of AAPM Report No. 74 

from the AAPM Web site at http:// 

www.aapm.org/pubs/reports/rpt_74.pdf 

or from Medical Physics Publishing, 

4513 Vernon Blvd., Madison, WI 53705. 

You may obtain a copy of AAPM Report 

No. 14 from http://www.aapm.org/pubs/ 

reports/rpt_14.pdf or from AAPM, 335 

E. 45 Street, New York, NY 10017. You 

may inspect a copy of AAPM Report No. 

74 or AAPM Report No. 14 at the 

NIOSH Docket Office, Robert A. Taft 

Laboratories, MS–C34, 4676 Columbia 

Parkway, Cincinnati, OH 45226, or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of these 

materials at NARA, call (202) 741–6030 

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

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

(2) Exposure parameters achieved 

during the evaluation of the automated 

exposure system shall be recorded by 

the medical physicist in a written report 

or electronic file that is stored at the 

facility and available for inspection by 

NIOSH for a minimum of 5 years after 

the miner’s examination. 

(i) To ensure high quality digital chest 

radiographs: 

(1) The maximum exposure time shall 

not exceed 50 milliseconds except for 

subjects with chests over 28 centimeters 

posteroanterior, for whom the exposure 

time shall not exceed 100 milliseconds; 

(2) The distance from source or focal 

spot to detector shall be at least 70 

inches (or 180 centimeters if measured 

in centimeters); 

(3) The exposure setting for chest 

images shall be within the range of 100– 

300 equivalent exposure speeds and 

shall comply with the American College 

of Radiology (ACR) Practice Guideline 

For Diagnostic Reference Levels in 

Medical X-Ray Imaging, Section V— 

Diagnostic Reference Levels For Imaging 

With Ionizing Radiation and Section 

VII—Radiation Safety in Imaging, 

Revised 2008 (Res. 3). The ACR Practice 

Guideline is incorporated by reference. 

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. You may obtain a copy 

of the ACR Practice Guideline from the 

ACR Web site at http://www.acr.org/ 

SecondaryMainMenuCategories/ 

quality_safety/guidelines/med_phys/ 

reference_levels.aspx. You may inspect 

a copy of the ACR Practice Guideline at 

the NIOSH Docket Office, Robert A. Taft 

Laboratories, MS–C34, 4676 Columbia 

Parkway, Cincinnati, OH 45226, 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. Radiation exposures 

should be periodically measured and 

patient radiation doses estimated by the 

medical physicist to assure doses are as 

low as reasonably achievable. 

(4) Digital radiography system 

performance, including image signal-tonoise and detective quantum efficiency 

shall be evaluated and judged 

acceptable by a qualified medical 

physicist using the specifications of the 

American Association of Physicists in 

Medicine, AAPM Report No. 93, 

Acceptance Testing and Quality Control 

of Photostimulable Storage Phosphor 

Imaging Systems, Report of AAPM Task 

Group 10, published by AAPM, October 

2006, pages 1–68. This report is 

incorporated by reference. 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. You may obtain a copy of 

AAPM Report No. 93 from the AAPM 

Web site at http://www.aapm.org/pubs/ 

reports/RPT_93.pdf or from AAPM, One 

Physics Ellipse, College Park, MD 

20740. You may inspect a copy of 

AAPM Report No. 93 at the NIOSH 

Docket Office, Robert A. Taft 

Laboratories, MS–C34, 4676 Columbia 

Parkway, Cincinnati, OH 45226, or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of these 

materials at NARA, call (202) 741–6030 

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

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. Image management 

software and settings for routine chest 

imaging shall be used, including routine 

amplification of digital detector signal 

as well as standard image postprocessing functions. No image or edge 

enhancement software functions shall 

be employed unless they are integral to 

the digital radiography system (not 

elective); in such cases, only the 

minimum image enhancement 

permitted by the system shall be 

employed. 

(5) (i) The image object, transmission 

and associated data storage, file format, 

and transmission of associated 

information shall conform to the 

following components of the National 

Electrical Manufacturers Association’s 

Digital Imaging and Communications in 

Medicine (DICOM) standard: 

(A) Part 3 (PS 3.3–2011): Information 

Object Definitions, Annex A— 

Composite Information Object 

Definitions, sections: Digital X-Ray 

Image Information Object Definition; XRay Radiation Dose SR Information 

Object Definition; and Grayscale 

Softcopy Presentation State Information 

Object Definition. 


tkelley on DSK3SPTVN1PROD with PROPOSALS4
Federal Register / Vol. 77, No. 5 / Monday, January 9, 2012 / Proposed Rules 1379 

1The plastic step-wedge object is described in 

Trout ED, Kelley JP [1973]. A phantom for the 

evaluation of techniques and equipment used for 

roentgenography of the chest. Amer J Roentgenol 

117(4):771–776. 

(B) Part 4 (PS3.4–2011): Service Class 

Specifications, sections: Annex B— 

Storage Service Class; Annex N— 

Softcopy Presentation State Storage SOP 

Classes; Annex O—Structured Reporting 

Storage SOP Classes. 

(C) Part 10 (PS 3.10–2011): Media 

Storage and File Format for Data 

Interchange. 

(D) Part 11 (PS 3.11–2011): Media 

Storage Application Profiles. 

(E) Part 12 (PS 3.12–2011): Media 

Formats and Physical Media for Media 

Interchange. 

(F) Part 14 (PS 3.14–2011): Grayscale 

Standard Display Function. 

(G) Part 16 (PS 3.16–2011): Content 

Mapping Resource, section: X-Ray 

Radiation Dose SR IOD Templates. 

(ii) The sections of the DICOM 

standard indicated above are 

incorporated by reference. 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. You may obtain a copy of 

the DICOM standard from the NEMA 

Web site at ftp://medical.nema.org/ 

medical/dicom/2011/ or from the 

National Electrical Manufacturers 

Association, 1300 N. 17th Street, 

Rosslyn, VA 22209. You may inspect a 

copy of the DICOM standard at the 

NIOSH Docket Office, Robert A. Taft 

Laboratories, MS–C34, 4676 Columbia 

Parkway, Cincinnati, OH 45226, or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of these 

materials at NARA, call (202) 741–6030 

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

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

(A) Identification of each miner, chest 

image, facility, date and time of the 

examination shall be encoded within 

the image information object, according 

to Part 3 (PS 3.3–2011) of the DICOM 

standard, Information Object 

Definitions, for the DICOM ‘‘DX’’ object. 

Part 3 is incorporated by reference and 

is available as indicated above. If data 

compression is performed, it shall be 

lossless. Exposure parameters (kVp, mA, 

time, beam filtration, scatter reduction, 

radiation exposure) shall be stored in 

the DX information object. 

(B) Exposure parameters as defined in 

the DICOM Standard PS 3.16–2011: 

Content Mapping Resource, shall 

additionally be provided, when such 

parameters are available from the 

facility digital image acquisition system 

or recorded in a written report or 

electronic file and either transmitted to 

NIOSH or stored at the facility and 

available for inspection by NIOSH for 5 

years after the examination. 

(6) A specific test object may be 

required on each radiograph for an 

objective evaluation of image quality at 

the discretion of NIOSH. 

(7) CR imaging plates shall be 

inspected at least once a month and 

cleaned when necessary by the method 

recommended by the manufacturer; 

(8) A grid or air gap for reducing 

scattered radiation shall be used; grids 

shall not be used that cause Moire ́

interference patterns in either horizontal 

or vertical images. 

(9) The geometry of the radiographic 

system shall ensure that the central axis 

(ray) of the primary beam is 

perpendicular to the plane of the CR 

imaging plate, or DR detector and is 

correctly aligned to the grid; 

(10) Radiographs shall not be made 

when the environmental temperatures 

and humidity in the facility are outside 

the manufacturer’s recommended range 

of the CR and DR equipment to be used. 

(11) Before the miner is advised that 

the examination is concluded, the 

radiograph shall be processed and 

inspected and accepted for quality by 

the physician, or if the physician is not 

available, acceptance may be made by 

the radiologic technologist. In a case of 

a substandard radiograph, another shall 

be made immediately. Unacceptable 

digital image files shall be fully deleted 

immediately or rendered permanently 

inaccessible in the event that permanent 

deletion is not technologically feasible. 

(j) The following are not authorized 

for use under this section: 

(1) Digital images derived from film 

screen chest radiographs (e.g., by 

scanning or digital photography); or 

(2) Images that were acquired using 

digital systems and then printed on 

transparencies for back-lighted display 

(e.g., using tradition view boxes). 

14. Revise newly designated § 37.43 to 

read as follows: 

§ 37.43 Approval of radiographic facilities 

that use film. 

(a) Facilities become eligible to 

participate in this program by 

demonstrating their ability to make high 

quality diagnostic chest radiographs by 

submitting to NIOSH six or more sample 

chest radiographs made and processed 

at the applicant facility and which are 

of acceptable quality to one or more 

individuals selected by NIOSH from the 

panel of B Readers. Applicants shall 

also submit a radiograph of a plastic 

step-wedge object 1 or other test object 

(available on loan from NIOSH) which 

was made and processed at the same 

time with the same technique as the 

radiographs submitted and processed at 

the facility for which approval is sought. 

At least one chest radiograph and one 

test object radiograph shall have been 

made with each unit to be used 

hereunder. All radiographs shall have 

been made within 15 calendar days 

prior to submission and shall be marked 

to identify the facility where each 

radiograph was made, the X-ray 

machine used, and the date each was 

made. The chest radiographs will be 

returned and may be the same 

radiographs submitted pursuant to 

§ 37.50. 

(b) Each radiographic facility 

submitting chest radiographs for 

approval under this section shall 

complete and include an X-ray Facility 

Certification Document (Form CDC/ 

NIOSH (M) 2.11) describing each X-ray 

unit to be used to make chest 

radiographs under the Act. The form 

shall include: 

(1) The date of the last radiation safety 

inspection by an appropriate licensing 

agency or, if no such agency exists, by 

a qualified expert as defined in NCRP 

Report No. 102 (see § 37.45); 

(2) The deficiencies found; 

(3) A statement that all the 

deficiencies have been corrected; and 

(4) The date of acquisition of the Xray unit. To be acceptable, the radiation 

safety inspection shall have been made 

within 1 year preceding the date of 

application. 

(c) Radiographs submitted with 

applications for approval under this 

section will be evaluated by one or more 

individuals selected by NIOSH from the 

panel of B Readers or by a qualified 

medical physicist or consultant. 

Applicants will be advised of any 

reasons for denial of approval. 

(d) NIOSH or its representatives may 

make a physical inspection of the 

applicant’s facility and any approved 

radiographic facility at any reasonable 

time to determine if the requirements of 

this subpart are being met. 

(e) NIOSH may require a facility 

periodically to resubmit radiographs of 

a test object, sample radiographs, or a 

Facility Certification Document for 

quality control purposes. Approvals 

granted hereunder may be suspended or 

withdrawn by notice in writing when in 

the opinion of NIOSH the quality of 

radiographs or information submitted 

under this section warrants such action. 

A copy of a notice withdrawing 

approval will be sent to each operator 

who has listed the facility as its facility 

for giving chest radiographs and shall be 

displayed on the mine bulletin board 

adjacent to the operator’s approved 


tkelley on DSK3SPTVN1PROD with PROPOSALS4
1380 Federal Register / Vol. 77, No. 5 / Monday, January 9, 2012 / Proposed Rules 

plan. The approved plan will be 

reevaluated by NIOSH in light of this 

change. 

(f) A formal written quality assurance 

program shall be established at each 

facility addressing radiation exposures, 

equipment maintenance, and image 

quality, and shall conform to the 

standards set by the American 

Association of Physicists in Medicine in 

AAPM Report No. 74, Quality Control in 

Diagnostic Radiology, Report of Task 

Group #12, Diagnostic X-Ray Imaging 

Committee, published by Medical 

Physics Publishing for AAPM, July 

2002, pages 1–19, 47–53, and 56. This 

report is incorporated by reference. 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. You may obtain a copy 

of AAPM Report No. 74 from the AAPM 

Web site at http://www.aapm.org/pubs/ 

reports/rpt_74.pdf or from Medical 

Physics Publishing, 4513 Vernon Blvd., 

Madison, WI 53705. You may inspect a 

copy of AAPM Report No. 74 at the 

NIOSH Docket Office, Robert A. Taft 

Laboratories, MS–C34, 4676 Columbia 

Parkway, Cincinnati, OH 45226, or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of these 

materials at NARA, call (202) 741–6030 

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

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

(g) In conducting medical 

examinations pursuant to this Part, 

physicians and radiographic facilities 

shall maintain the results and analysis 

of these examinations (including any 

hard copies or digital files containing 

individual data, interpretations, and 

images) consistent with applicable 

statutes and regulations governing the 

treatment of individually identifiable 

health information, including, as 

applicable, the HIPAA Privacy and 

Security Rules (45 CFR part 160 and 

subparts A, C, and E of part 164). 

15. Add § 37.44 to read as follows: 

§ 37.44 Approval of radiographic facilities 

that use digital radiography systems. 

(a) Applications for facility approval. 

(1) Facilities seeking approval shall 

demonstrate the ability to make high 

quality digital chest radiographs by 

submitting to NIOSH digital 

radiographic image files of a test object 

(e.g., a plastic step-wedge or chest 

phantom which will be provided on 

loan from NIOSH) as well as digital 

radiographic image files from six or 

more sample chest radiographs which 

are of acceptable quality to (1) one or 

more individuals selected by NIOSH 

from the panel of B Readers and (2) a 

qualified medical physicist or 

consultant, both designated by NIOSH. 

Image files shall be submitted on 

standard portable media (compact or 

digital video disc) and formatted to meet 

specifications of the Digital Imaging and 

Communications in Medicine (DICOM) 

standard for diagnostic media 

interchange Part 12 (PS 3.12–2011): 

Media Formats and Physical Media for 

Media Interchange. Applicants will be 

advised of any reasons for denial of 

approval. All submitted images shall be 

made within 60 days prior to the date 

of application using the same technique, 

equipment, and software as will be used 

by the facility under the requested 

approval. At least six chest radiographs 

and one test object radiograph shall 

have been made with each digital 

radiographic unit to be used by the 

facility under the requested approval. 

The corresponding radiographic image 

files shall be submitted on standard 

portable media (compact or digital video 

disc) and formatted to meet 

specifications of the current Digital 

Imaging and Communications in 

Medicine (DICOM) standard for 

diagnostic media interchange Part 12 

(PS 3.12–2011): Media Formats and 

Physical Media for Media Interchange. 

DICOM Part 12 is incorporated by 

reference. 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. You may 

obtain a copy of the DICOM standard 

from the NEMA Web site at ftp:// 

medical.nema.org/medical/dicom/2011/ 

or from the National Electrical 

Manufacturers Association, 1300 N. 

17th Street, Rosslyn, VA 22209. You 

may inspect a copy of the DICOM 

standard at the NIOSH Docket Office, 

Robert A. Taft Laboratories, MS–C34, 

4676 Columbia Parkway, Cincinnati, OH 

45226, or at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

document at NARA, call (202) 741–6030 

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

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. Documentation shall 

include the following: the identity of the 

facility where each radiograph was 

made; the X-ray machine used; and the 

model, version, and production date of 

each image acquisition software 

program and hardware component. The 

submitted sample digital chest image 

files shall include at least two taken 

with the detector in the vertical position 

and two in the horizontal position 

where the imaging system permits these 

positions, and at least two chest images 

shall be from persons within the highest 

quartile of chest diameters (28 cm or 

greater). 

(2) Each radiographic facility 

submitting chest radiographic image 

files for approval under this section 

shall complete and include an X-ray 

Facility Certification Document (Form 

CDC/NIOSH (M)2.11) describing each Xray system component, and the models 

and versions of image acquisition 

hardware and software to be used to 

make digital chest radiographs under 

the Act. The form shall include: 

(i) A copy of a dated report signed by 

a qualified medical physicist, 

documenting the evaluation of radiation 

safety and performance characteristics 

specified in this regulation for each 

digital radiography system; 

(ii) A copy of the report of the most 

recent radiation safety inspection by a 

licensing agency, if such agency exists; 

(iii) A listing of all deficiencies noted 

in either of the reports; 

(iv) A statement that all the listed 

deficiencies have been corrected; and 

(v) The names and relevant training 

and experience of facility personnel 

described in paragraphs (b), (d), and (e) 

of this section. To be acceptable, the 

report by the medical physicist and 

radiation safety inspection specified in 

this paragraph shall have been made 

within 1 year prior to the date of 

submission of the application. 

(b) Facilities shall maintain ongoing 

licensure and certification under 

relevant local, State, and Federal laws 

and regulations for all digital equipment 

and related processes covered under 

this Part. 

(c) NIOSH or its representatives may 

make a physical inspection of the 

applicant’s facility and any approved 

radiographic facility at any reasonable 

time to determine if the requirements of 

this subpart are being met. 

(d) NIOSH may periodically require a 

facility to resubmit radiographic image 

files of the NIOSH-supplied test object 

(e.g., step-wedge or chest phantom), 

sample radiographs, or a Facility 

Certification Document. Approvals 

granted to facilities under this section 

may be suspended or withdrawn by 

notice in writing when, in the opinion 

of NIOSH, deficiencies in the quality of 

radiographs or information submitted 

under this section warrant such action. 

A copy of a notice suspending or 

withdrawing approval will be sent to 

each operator that has listed the facility 

for its use under this Part and shall be 

displayed on the mine bulletin board 

adjacent to the operator’s approved 

plan. The operator’s approved plan may 

be reevaluated by NIOSH in response to 

such suspension or withdrawal. 


tkelley on DSK3SPTVN1PROD with PROPOSALS4
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(e) A qualified medical physicist who 

is familiar with the facility hardware 

and software systems for image 

acquisition, manipulation, display, and 

storage, shall be on site or available as 

a consultant. The physicist shall be 

trained in evaluating the performance of 

radiographic equipment and facility 

quality assurance programs, and shall be 

licensed/approved by a State or territory 

of the United States or certified by a 

competent U.S. national board. 

(f) Facilities shall document that 

testing performed by a qualified medical 

physicist has verified that performance 

of each image acquisition system for 

which approval is sought met initial 

specifications and standards of the 

equipment manufacturer and 

performance testing as required under 

paragraphs (b), (e), and (g) of this 

section. 

(g) A formal written quality assurance 

program shall be established at each 

facility addressing radiation exposures, 

equipment maintenance, and image 

quality, and shall conform to the 

standards set by the American 

Association of Physicists in Medicine in 

AAPM Report No. 74, Quality Control in 

Diagnostic Radiology, Report of Task 

Group #12, Diagnostic X–Ray Imaging 

Committee, published by Medical 

Physics Publishing for AAPM, July 

2002, pages 1–19, 47–53, and 56, and 

AAPM Report No. 116, An Exposure 

Indicator for Digital Radiography, 

Report of AAPM Task Group 116, 

published by AAPM, July 2009, sections 

VIII, IX, and X. These reports are 

incorporated by reference. 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. You may obtain a copy of 

AAPM Report No. 74 from the AAPM 

Web site at http://www.aapm.org/pubs/ 

reports/rpt_74.pdf or from Medical 

Physics Publishing, 4513 Vernon Blvd., 

Madison, WI 53705. You may obtain a 

copy of AAPM Report No. 116 from the 

AAPM Web site at http:// 

www.aapm.org/pubs/reports/ 

RPT_116.PDF or from American 

Association of Physicists in Medicine, 

One Physics Ellipse, College Park, MD 

20740. You may inspect a copy of 

AAPM Report No. 74 and No. 116 at the 

NIOSH Docket Office, Robert A. Taft 

Laboratories, MS–C34, 4676 Columbia 

Parkway, Cincinnati, OH 45226, or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of these 

materials at NARA, call (202) 741–6030 

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

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

(1) Applications for facility approval 

shall include a comprehensive 

assessment by a qualified medical 

physicist within 12 months prior to 

application addressing the performance 

of X-ray generators, automatic exposure 

controls, and image capture systems. 

The assessment shall comply with the 

following guidelines: American 

Association of Physicists in Medicine, 

AAPM Report No. 93, Acceptance 

Testing and Quality Control of 

Photostimulable Storage Phosphor 

Imaging Systems, Report of AAPM Task 

Group 10, published by AAPM, October 

2006, pages 1–68; AAPM Report No. 74, 

Quality Control in Diagnostic Radiology, 

Report of Task Group #12, Diagnostic XRay Imaging Committee, published by 

Medical Physics Publishing for AAPM, 

July 2002, page 6–11; and AAPM Report 

No. 14, Performance Specifications and 

Acceptance Testing for X-Ray 

Generators and Automatic Exposure 

Control Devices, Report of the 

Diagnostic X-Ray Imaging Committee 

Task Group on Performance 

Specifications and Acceptance Testing 

for X-Ray Generators and Automatic 

Exposure Control Devices, published by 

the American Institute of Physics, 

January 1985, pages 1–96. These reports 

are incorporated by reference. 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. You may obtain a copy 

of AAPM Report No. 93 from the AAPM 

Web site at http://www.aapm.org/pubs/ 

reports/RPT_93.pdf or from the 

American Association of Physicists in 

Medicine, One Physics Ellipse, College 

Park, MD 20740. You may obtain a copy 

of AAPM Report No. 74 from the AAPM 

Web site at http://www.aapm.org/pubs/ 

reports/rpt_74.pdf or from Medical 

Physics Publishing, 4513 Vernon Blvd., 

Madison, WI 53705. You may obtain a 

copy of AAPM Report No.14 from the 

AAPRM Web site at http:// 

www.aapm.org/pubs/reports/rpt_14.pdf 

or from the Executive Secretary, 

American Association of Physicists in 

Medicine, 335 E. 45 Street, New York, 

NY 10017. A copy of AAPM Reports No. 

93, 74, and 14 may be inspected at the 

NIOSH Docket Office, Robert A. Taft 

Laboratories, MS–C34, 4676 Columbia 

Parkway, Cincinnati, OH 45226, or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of these 

materials at NARA, call (202) 741–6030 

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

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

(2) Radiographic technique charts 

shall be used that are developed 

specifically for the X-ray system and 

detector combinations used, indicating 

exposure parameters by anatomic 

measurements. If automated exposure 

control devices are used, calibration for 

chest imaging shall be documented 

using the actual voltages and image 

capture systems. Radiological exposures 

resulting from at least ten (randomly 

selected) digital chest images obtained 

at the facility shall be monitored at least 

quarterly to detect and correct potential 

dose creep, using methods specified in: 

American Association of Physicists in 

Medicine in AAPM Report No. 31, 

Standardized Methods for Measuring 

Diagnostic X-Ray Exposures, Report of 

Task Group 8, Diagnostic X-Ray Imaging 

Committee, published by the American 

Institute of Physics, March 2005. This 

report is incorporated by reference. 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. You may obtain a copy 

of AAPM Report No. 31 from the AAPM 

Web site at http://www.aapm.org/pubs/ 

reports/RPT_31.pdf or from the 

American Institute of Physics, c/o AIDC, 

64 Depot Road, Colchester, VT 05446. A 

copy of AAPM Report No. 31 may be 

inspected at the NIOSH Docket Office, 

Robert A. Taft Laboratories, MS–C34, 

4676 Columbia Parkway, Cincinnati, OH 

45226, or at the National Archives and 

Records Administration (NARA). For 

information on the availability of these 

materials at NARA, call (202) 741–6030 

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

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. Radiation exposures 

shall be compared to a professionally 

accepted reference level published in 

the American College of Radiology 

(ACR) Practice Guideline For Diagnostic 

Reference Levels in Medical X-Ray 

Imaging, Revised 2008 (Res. 3), pages 1– 

6. The ACR Practice Guideline is 

incorporated by reference. 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. You may obtain a copy of 

the ACR Practice Guideline from the 

ACR Web site at http://www.acr.org/ 

SecondaryMainMenuCategories/ 

quality_safety/guidelines/med_phys/ 

reference_levels.aspx. You may inspect 

a copy of the ACR Practice Guideline at 

the NIOSH Docket Office, Robert A. Taft 

Laboratories, MS–C34, 4676 Columbia 

Parkway, Cincinnati, OH 45226, or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of this 


tkelley on DSK3SPTVN1PROD with PROPOSALS4
1382 Federal Register / Vol. 77, No. 5 / Monday, January 9, 2012 / Proposed Rules 

material at NARA, call (202) 741–6030 

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

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. In addition, the 

medical physicist shall submit an 

annual assessment of measured or 

estimated radiation exposures, with 

specific recommended actions to 

minimize exposures during 

examinations performed under this Part. 

(3) For each digital radiography 

device and system, performance shall be 

monitored annually in accordance with 

the recommendations of AAPM Report 

No. 93, except for the testing 

specifically excluded below. 

Documentation shall be maintained on 

the completion of quality assurance 

testing, including the reproducibility of 

X-ray output, linearity and 

reproducibility of mA settings, accuracy 

and reproducibility of timer and kVp 

settings, accuracy of source-to-detector 

distance, and X-ray field focal spot size, 

selection, beam quality, congruence and 

collimation. For DR systems, the 

following tests listed in AAPM Report 

No. 93, Acceptance Testing and Quality 

Control of Photostimulable Storage 

Phosphor Imaging Systems, 2006, are 

not required under this Part: 

(i) Section 8.4.5: Laser beam function 

(ii) Section 8.4.9: Erasure Thoroughness 

(iii) Section 8.4.11: Imaging Plate (IP) 

Throughput 

(4) Facilities shall maintain 

documentation, available for inspection 

by NIOSH for 5 years, of the ongoing 

implementation of policies and 

procedures for monitoring and 

evaluating the effective management, 

safety, and proper performance of chest 

image acquisition, digitization, 

processing, compression, transmission, 

display, archiving, and retrieval 

functions of digital radiography devices 

and systems. 

(h) In conducting medical 

examinations pursuant to this Part, 

physicians and radiographic facilities 

shall maintain the results and analysis 

of these examinations (including any 

hard copies or digital files containing 

individual data, interpretations, and 

images) consistent with applicable 

statutes and regulations governing the 

treatment of individually identifiable 

health information, including, as 

applicable, the HIPAA Privacy and 

Security Rules (45 CFR Part 160 and 

Subparts A, C, and E of Part 164). 

16. Revise newly designated § 37.45 to 

read as follows: 

§ 37.45 Protection against radiation 

emitted by radiographic equipment. 

Except as otherwise specified in 

§ 37.41 and § 37.42, radiographic 

equipment, its use and the facilities 

(including mobile facilities) in which 

such equipment is used, shall conform 

to applicable State or territorial and 

Federal regulations. Where no 

applicable regulations exist, 

radiographic equipment, its use and the 

facilities (including mobile facilities) in 

which such equipment is used shall 

conform to the recommendations of the 

National Council on Radiation 

Protection and Measurements in NCRP 

Report No. 102, Medical X-ray, Electron 

Beam, and Gamma-Ray Protection for 

Energies Up to 50 MeV, Equipment 

Design, Performance, and Use, 1989; 

NCRP Report No. 105, Medical 

Radiation Protection for Medical and 

Allied Health Personnel, 1989; and in 

NCRP Report No. 49, Structural 

Shielding Design and Evaluation for 

Medical Use of X–Rays and Gamma 

Rays of Energies up to 10 MeV, 1976. 

These documents are incorporated by 

reference. 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. You may 

obtain a copy of the NCRP reports from 

NCRP Publications, 7910 Woodmont 

Avenue, Suite 400, Bethesda, MD 

20814–3095, Telephone (800) 229–2652 

or from http://www.ncrponline.org/ 

Publications/Publications.html. You 

may inspect a copy of the ACR Practice 

Guideline at the NIOSH Docket Office, 

Robert A. Taft Laboratories, MS–C34, 

4676 Columbia Parkway, Cincinnati, OH 

45226, or at the National Archives and 

Records Administration (NARA). For 

information on the availability of these 

materials at NARA, call (202) 741–6030 

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

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

17. Revise the undesignated center 

heading and § 37.50 to read as follows: 

Specifications for Interpretation, 

Classification, and Submission of Chest 

Radiographs 

§ 37.50 Interpreting and classifying chest 

radiographs—film. 

(a) Chest radiographs shall be 

interpreted and classified in accordance 

with the International Labour Office 

(ILO) International Classification of 

Radiographs for Pneumoconioses, 2011. 

The ILO Classification is incorporated 

by reference. 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. You may 

purchase a copy of the ILO 

Classification from ILO Publications, 

International Labour Office, CH–1211 

Geneva 22, Switzerland, or from the ILO 

Web site at http://www.ilo.org/publns. 

You may inspect the ILO Classification 

at the NIOSH Docket Office, Robert A. 

Taft Laboratories, MS–C34, 4676 

Columbia Parkway, Cincinnati, OH 

45226, or at the National Archives and 

Records Administration (NARA). For 

information on the availability of these 

materials at NARA, call (202) 741–6030 

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

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. Chest radiograph 

interpretations and classifications shall 

be recorded on a paper or electronic 

Roentgenographic Interpretation Form 

(Form CDC/NIOSH (M)2.8). 

(b) Radiographs shall be interpreted 

and classified only by a physician who 

reads chest radiographs in the normal 

course of practice and who has 

demonstrated proficiency in classifying 

the pneumoconioses in accordance with 

§ 37.52. 

(1) Initial clinical interpretations and 

notification of findings other than 

pneumoconiosis under § 37.50(a) shall 

be provided by a qualified physician 

who has all required licensure and 

privileges, and interprets chest 

radiographs in the normal course of 

practice. 

(c) All interpreters, whenever 

interpreting chest radiographs made 

under the Act, shall have immediately 

available for reference a complete set of 

the ILO International Classification of 

Radiographs for Pneumoconioses, 2011. 

(d) In all view boxes used for making 

interpretations: 

(1) Fluorescent lamps shall be 

simultaneously replaced with new 

lamps at 6-month intervals; 

(2) All the fluorescent lamps in a 

panel of boxes shall have identical 

manufacturer’s ratings as to intensity 

and color; 

(3) The glass, internal reflective 

surfaces, and the lamps shall be kept 

clean; 

(4) The unit shall be so situated as to 

minimize front surface glare. 

§§ 37.51–37.53 [Redesignated] 

18a. Redesignate §§ 37.51 through 

37.53 as §§ 37.52 through 37.54 

respectively. 

18b. Add new § 37.51 to read as 

follows: 

§ 37.51 Interpreting and classifying chest 

radiographs—digital radiography systems. 

(a) For each chest radiograph obtained 

at an approved facility using a digital 

radiography system, a qualified and 

licensed physician who reads chest 

radiographs in the normal course of 

practice shall provide an initial clinical 

interpretation and notification, as 


tkelley on DSK3SPTVN1PROD with PROPOSALS4
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specified in § 37.54, of any significant 

abnormal findings other than 

pneumoconiosis. 

(b) Chest radiographs shall be 

classified for pneumoconiosis by 

physician readers who have 

demonstrated ongoing proficiency, as 

specified in § 37.52(b), in classifying the 

pneumoconioses in a manner consistent 

with the ILO International Classification 

of Radiographs of Pneumoconioses 

2011. The ILO Classification is 

incorporated by reference. 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. You may purchase a copy 

of the ILO Classification from ILO 

Publications, International Labour 

Office, CH–1211 Geneva 22, 

Switzerland, or from the ILO Web site 

at http://www.ilo.org/publns. You may 

inspect the ILO Classification at the 

NIOSH Docket Office, Robert A. Taft 

Laboratories, MS–C34, 4676 Columbia 

Parkway, Cincinnati, OH 45226, or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of these 

materials at NARA, call (202) 741–6030 

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

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. Chest radiograph 

interpretations and classifications shall 

be recorded on a paper or electronic 

Roentgenographic Interpretation Form 

(Form CDC/NIOSH (M)2.8). 

(c) All interpreters, whenever 

classifying digitally-acquired chest 

radiographs made under the Act, shall 

have immediately available for reference 

a complete set of NIOSH-approved 

standard digital chest radiographic 

images provided for use with the ILO 

International Classification of 

Radiographs of Pneumoconioses, 2011. 

Only NIOSH-approved standard digital 

images shall be used for classifying 

digital chest images for 

pneumoconiosis. Modification of the 

appearance of the standard images using 

software tools is not permitted. 

(d) Viewing systems should enable 

readers to display the coal miner’s chest 

image at the full resolution of the image 

acquisition system, side-by-side with 

the selected NIOSH-approved standard 

images for comparison. 

(1) Image display devices shall be flat 

panel monitors displaying at least 3 MP 

at 10 bit depth. Image displays and 

associated graphics cards shall meet the 

calibration and other specifications of 

the National Electrical Manufacturers 

Association’s Digital Imaging and 

Communications in Medicine (DICOM) 

standard Part 14 (PS 3.14–2011): 

Grayscale Standard Display Function. 

DICOM Part 14 is incorporated by 

reference. 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. You may 

obtain a copy of the DICOM standard 

from the NEMA Web site at ftp:// 

medical.nema.org/medical/dicom/2011/ 

or from the National Electrical 

Manufacturers Association, 1300 N. 

17th Street, Rosslyn, VA 22209. You 

may inspect a copy of the DICOM 

standard at the NIOSH Docket Office, 

Robert A. Taft Laboratories, MS–C34, 

4676 Columbia Parkway, Cincinnati, OH 

45226, or at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

document at NARA, call (202) 741–6030 

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

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

Image displays and associated 

graphics cards shall not deviate by more 

than 10 percent from the grayscale 

standard display function (GSDF) when 

assessed according the American 

Association of Physicists in Medicine 

(AAPM) On-Line Report No. 03, 

Assessment of Display Performance for 

Medical Imaging Systems, Task Group 

18, Imaging Informatics Subcommittee, 

published by AAPM, April 2005, pages 

1–146. This report is incorporated by 

reference. 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. You may 

obtain a copy of On-Line Report No. 03 

from American Association of Physicists 

in Medicine, One Physics Ellipse, 

College Park, MD 20740 or from 

http://www.aapm.org/pubs/reports/ 

OR_03.pdf. You may inspect a copy of 

AAPM On-Line Report No. 03 at the 

NIOSH Docket Office, Robert A. Taft 

Laboratories, MS–C34, 4676 Columbia 

Parkway, Cincinnati, OH 45226, or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of this 

document at NARA, call (202) 741–6030 

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

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

(2) Display system luminance 

(maximum and ratio), relative noise, 

linearity, modulation transfer function 

(MTF), frequency, and glare should 

meet or exceed recommendations listed 

in AAPM On-Line Report No. 03, 

Assessment of Display Performance for 

Medical Imaging Systems, Task Group 

18, Imaging Informatics Subcommittee, 

published by AAPM, April 2005, pages 

1–146. This report is incorporated by 

reference. 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. You may 

obtain a copy of On-Line Report No. 03 

from American Association of Physicists 

in Medicine, One Physics Ellipse, 

College Park, MD 20740 or from 

http://www.aapm.org/pubs/reports/ 

OR_03.pdf. You may inspect a copy of 

AAPM On-Line Report No. 03 at the 

NIOSH Docket Office, Robert A. Taft 

Laboratories, MS–C34, 4676 Columbia 

Parkway, Cincinnati, OH 45226, or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of this 

document at NARA, call (202) 741–6030 

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

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. Viewing displays 

shall have a maximum luminance of at 

least 171 cd/m2, a ratio of maximum 

luminance to minimum luminance of at 

least 250, and a glare ratio greater than 

400. The contribution of ambient light 

reflected from the display surface, after 

light sources have been minimized, 

shall be included in luminance 

measurements. 

(3) Displays shall be situated so as to 

minimize front surface glare. Readers 

shall minimize reflected light from 

ambient sources during the performance 

of classifications. 

(4) Measurements of the width and 

length of pleural shadows and the 

diameter of opacities shall be taken 

using calibrated software measuring 

tools. If permitted by the viewing 

software, a record shall be made of the 

presentation state(s), including any 

noise reduction and edge enhancement 

or restoration functions that were used 

in performing the classification, 

including any annotations and 

measurements. 

(e) Quality control procedures for 

devices used to display chest images for 

classification shall comply with the 

recommendations of the American 

Association of Physicists in Medicine 

AAPM On-Line Report No. 03, 

Assessment of Display Performance for 

Medical Imaging Systems, Task Group 

18, Imaging Informatics Subcommittee, 

published by AAPM, April 2005, pages 

1–146. This report is incorporated by 

reference. 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. You may 

obtain a copy of On-Line Report No. 03 

from American Association of Physicists 

in Medicine, One Physics Ellipse, 

College Park, MD 20740 or from 

http://www.aapm.org/pubs/reports/ 

OR_03.pdf. You may inspect a copy of 

AAPM On-Line Report No. 03 at the 


tkelley on DSK3SPTVN1PROD with PROPOSALS4
1384 Federal Register / Vol. 77, No. 5 / Monday, January 9, 2012 / Proposed Rules 

2NIOSH Safety and Health Topic. Chest 

Radiography: Radiographic Classification [http:// 

www.cdc.gov/niosh/topics/chestradiography/ 

radiographic-classification.html]. Date accessed: 

January 25, 2011. 

NIOSH Docket Office, Robert A. Taft 

Laboratories, MS–C34, 4676 Columbia 

Parkway, Cincinnati, OH 45226, or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of this 

document at NARA, call (202) 741–6030 

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

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

(1) If automatic quality assurance 

systems are used, visual inspection shall 

be performed using one or more test 

patterns recommended by the medical 

physicist every 6 months, or more 

frequently, to check for defects that 

automatic systems may not detect. 

(2) [Reserved] 

(f) Classification of CR and DR 

digitally-acquired chest radiographs 

under this Part shall be performed based 

on the viewing of images displayed as 

soft copies using the viewing 

workstations specified in this section. 

Classification of radiographs shall not 

be based on the viewing of hard copy 

printed transparencies of images that 

were digitally-acquired. 

(g) The classification chest 

radiographs based on digitized copies of 

chest radiographs that were originally 

acquired using film-screen techniques is 

not permissible under this Part. 

19. Revise newly designated § 37.52 to 

read as follows: 

§ 37.52 Proficiency in the use of systems 

for classifying the pneumoconioses. 

(a) First or A Readers: 

(1) Approval as an A Reader shall 

continue if established prior to the 

effective date of these regulations. 

(2) Physicians who desire to be A 

Readers must demonstrate their 

proficiency in classifying the 

pneumoconioses by either: 

(i) Submitting to NIOSH from the 

physician’s files six sample chest 

radiographs which are considered 

properly classified by one or more 

individuals selected by NIOSH from the 

panel of B Readers. The six radiographs 

shall consist of two without 

pneumoconiosis, two with simple 

pneumoconiosis, and two with 

complicated pneumoconiosis (these 

may be the same radiographs submitted 

for facility approval pursuant to § 37.43 

and § 37.44). The films will be returned 

to the physician. The interpretations 

shall be on the Roentgenographic 

Interpretation Form (Form CDC/NIOSH 

(M)2.8), or; 

(ii) Satisfactory completion, since 

June 11, 1970, of a course approved by 

NIOSH on the ILO International 

Classification of Radiographs of 

Pneumoconioses. 

(b) Final or B Readers: 

(1) Approval as a B Reader established 

prior to October 1, 1976, shall hereby be 

terminated. 

(2) Proficiency in evaluating chest 

radiographs for radiographic quality and 

in the use of the ILO Classification for 

interpreting chest radiographs for 

pneumoconiosis and other diseases 

shall be demonstrated by those 

physicians who desire to be B Readers 

by taking and passing a speciallydesigned proficiency examination given 

on behalf of or by NIOSH at a time and 

place specified by NIOSH. Each 

physician who desires to take the digital 

version of the examination will be 

provided a complete set of the current 

NIOSH-approved standard reference 

digital radiographs. Physicians who 

qualify under this provision need not be 

qualified under paragraph (a) of this 

section. 

(c) Physicians who wish to participate 

in the program shall familiarize 

themselves with the necessary 

components for attainment of reliable 

classification of chest radiographs for 

the pneumoconioses 2 and apply using 

an Interpreting Physician Certification 

Document (Form CDC/NIOSH (M)2.12). 

20. Revise newly designated § 37.53 to 

read as follows: 

§ 37.53 Method of obtaining definitive 

interpretations. 

(a) All chest radiographs which are 

first interpreted by an A or B Reader 

will be submitted by NIOSH to a B 

Reader qualified as described in § 37.52. 

If there is agreement between the two 

interpretations, as described in 

paragraph (b) of this section, the result 

shall be considered final and reported to 

MSHA for transmittal to the miner. 

When agreement is lacking, NIOSH 

shall obtain a third interpretation from 

the panel of B Readers. If any two of the 

three interpretations demonstrate 

agreement, the result shall be 

considered the final determination. If 

agreement is lacking among the three 

interpretations, NIOSH will obtain 

independent classifications from two 

additional B Readers selected from the 

panel, and the final determination will 

be the median category derived from the 

total of five classifications. 

(b) Two interpretations shall be 

considered to be in agreement when 

they are derived from complete 

classifications recorded using approved 

paper or electronic versions of the 

Roentgenographic Interpretation Form 

(Form CDC/NIOSH (M)2.8) and received 

by NIOSH, and both find either stage A, 

B, or C complicated pneumoconiosis, or, 

for simple pneumoconiosis, are both in 

the same major category or (with one 

exception noted below) are within one 

minor category (ILO Classification 12- 

point scale) of each other. In the last 

situation, the higher of the two 

interpretations shall be reported. The 

only exception to the one minor 

category principle is a reading sequence 

of 0/1, 1/0, or 1/0, 0/1, which is not 

considered agreement. 

21. Revise newly designated § 37.54 to 

read as follows: 

§ 37.54 Notification of abnormal 

radiographic findings. 

(a) Findings of, or findings suggesting, 

enlarged heart, tuberculosis, lung 

cancer, or any other significant 

abnormal findings other than 

pneumoconiosis shall be communicated 

by the first physician to interpret the 

radiograph to the miner or to the 

designated physician of the miner 

indicated on the Miner Identification 

Document. A notice of the 

communication shall be submitted to 

NIOSH. NIOSH will also notify the 

miner to contact his or her physician 

when any physician who interprets and 

classifies the miner’s radiograph reports 

significant abnormal findings other than 

pneumoconiosis. 

(b) In addition, when NIOSH has 

more than one radiograph of a miner in 

its files and the most recent examination 

was interpreted to show enlarged heart, 

tuberculosis, cancer, complicated 

pneumoconiosis, and any other 

significant abnormal findings, NIOSH 

will submit all of the miner’s 

radiographs in its files with their 

respective interpretations to a B Reader. 

The B Reader will report any significant 

changes or progression of disease or 

other comments to NIOSH and NIOSH 

shall submit a copy of the report to the 

miner or to the miner’s designated 

physician. 

(c) All final findings regarding 

pneumoconiosis will be sent to the 

miner by MSHA in accordance with 

section 203 of the Act (see 30 CFR part 

90). Positive findings with regard to 

pneumoconiosis will be reported to the 

miner or to the miner’s designated 

physician by NIOSH. 

(d) NIOSH will make every reasonable 

effort to process the findings described 

in paragraph (c) of this section within 

60 days of receipt of the information 

described in § 37.60 in a complete and 

acceptable form. The information 

forwarded to MSHA will be in a form 

intended to facilitate prompt dispatch of 

the findings to the miner. The results of 


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Federal Register / Vol. 77, No. 5 / Monday, January 9, 2012 / Proposed Rules 1385 

an examination made of a miner may 

not be processed by NIOSH if the 

examination was made within 6 months 

of the date of a previous acceptable 

examination. 

22. Amend § 37.60 by revising 

paragraphs (a) through (d) to read as 

follows: 

§ 37.60 Submitting required chest 

radiographs and miner identification 

documents. 

(a) Each chest radiograph required to 

be made under this subpart, together 

with the completed Roentgenographic 

Interpretation Form and the completed 

Miner Identification Document, shall be 

submitted together for each miner to 

NIOSH within 14 calendar days after the 

radiographic examination is given and 

become the property of NIOSH. 

(1) When the radiograph is digital, the 

image file for each radiograph, together 

with either hard copy or electronic 

versions of the completed 

Roentgenographic Interpretation Form 

and the completed Miner Identification 

Document, shall be submitted to NIOSH 

using the software and format specified 

by NIOSH either using portable 

electronic media, or a secure electronic 

file transfer within 14 calendar days 

after the radiographic examination. 

NIOSH will notify the submitting 

facility when it has received the image 

files and forms from the examination. 

After this notification, the facility will 

permanently delete, or if this is not 

technologically feasible for the imaging 

system used, render permanently 

inaccessible all files and forms from its 

electronic and physical files. 

(2) [Reserved] 

(b) If NIOSH deems any submission 

under paragraph (a) of this section 

inadequate, it will notify the operator of 

the deficiency. The operator shall 

promptly make appropriate 

arrangements for the necessary 

reexamination. 

(c) Failure to comply with paragraph 

(a) or (b) of this section shall be cause 

to revoke approval of a plan or any other 

approval as may be appropriate. An 

approval which has been revoked may 

be reinstated at the discretion of NIOSH 

after it receives satisfactory assurances 

and evidence that all deficiencies have 

been corrected and that effective 

controls have been instituted to prevent 

a recurrence. 

(d) Chest radiographs and other 

required documents shall be submitted 

only for miners. 

* * * * * 

23. Revise § 37.70 to read as follows: 

§ 37.70 Review of interpretations. 

(a) Any miner who believes the 

interpretation for pneumoconiosis 

reported to him or her by MSHA is in 

error may file a written request with 

NIOSH that his or her radiograph be 

reevaluated. If the interpretation was 

based on agreement between an A 

Reader and a B Reader, NIOSH will 

obtain one or more additional 

interpretations by B Readers as 

necessary to obtain agreement in accord 

with § 37.53, and MSHA shall report the 

results to the miner together with 

notification from MSHA of any rights 

which may accrue to the miner in 

accordance with § 37.7. If the reported 

interpretation was based on agreement 

between two (or more) B Readers, the 

reading will be accepted as conclusive 

and the miner shall be so informed by 

MSHA. 

(b) Any operator who is directed by 

MSHA to transfer a miner to a less dusty 

atmosphere based on the most recent 

examination made subsequent to August 

1, 1978, may file a written request with 

NIOSH to review its findings. The 

standards set forth in paragraph (a) of 

this section apply and the operator and 

miner will be notified by MSHA 

whether the miner is entitled to the 

option to transfer. 

24. Revise § 37.80 to read as follows: 

§ 37.80 Availability of records for 

radiographs. 

(a) Medical information and 

radiographs on miners will be released 

by NIOSH only with the written consent 

from the miner, or if the miner is 

deceased, written consent from the 

miner’s widow or widower, next of kin, 

or legal representative. 

(b) To the extent authorized, 

radiographs will be made available for 

examination only at NIOSH. 

25. Amend § 37.201 by revising 

paragraph (d) to read as follows: 

§ 37.201 Definitions. 

* * * * * 

(d) NIOSH means the National 

Institute for Occupational Safety and 

Health, United States Public Health 

Service, Department of Health and 

Human Services, Post Office Box 4258, 

Morgantown, WV 26504. 

26. Amend § 37.202 by revising 

paragraphs (a)(2) and (b) to read as 

follows: 

§ 37.202 Payment for autopsy. 

(a) * * * 

(2) Submits the findings and other 

materials to NIOSH in accordance with 

this subpart within 180 calendar days 

after having performed the autopsy; and 

* * * * * 

(b) The Secretary will pay to any 

pathologist entitled to payment under 

paragraph (a) of this section and 

additional $10 if the pathologist can 

obtain and submits a good quality copy 

or original of a chest radiograph 

(posteroanterior view) made of the 

subject of the autopsy within 5 years 

prior to his death together with a copy 

of any interpretation made. 

26. Amend § 37.204 by revising the 

introductory text and paragraph (b), and 

removing Figure 1, to read as follows: 

§ 37.204 Procedure for obtaining payment. 

Every claim for payment under this 

subpart shall be submitted to NIOSH 

and shall include: 

* * * * * 

(b) Completed PHS Consent, Release 

and History form (Form CDC/NIOSH 

(M)2.6). This form may be completed 

with the assistance of the pathologist, 

attending physician, family physician, 

or any other responsible person who can 

provide reliable information. 

* * * * * 

Dated: October 11, 2011. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2011–33164 Filed 1–6–12; 8:45 am] 

BILLING CODE 4163–18–P 


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