Vol. 77 Thursday, 

No. 178 September 13, 2012 

Part II 

Department of Health and Human Services 

42 CFR Part 37 

Specifications for Medical Examinations of Underground Coal Miners; Final 

Rule 

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56718 Federal Register / Vol. 77, No. 178 / Thursday, September 13, 2012 / Rules and Regulations 

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. 

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 (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Final rule. 

SUMMARY: This final rule modifies the 

Department of Health and Human 

Services (HHS) regulations for medical 

examinations of underground coal 

miners. Existing regulations established 

specifications for providing, 

interpreting, classifying, and submitting 

film-based roentgenograms (now 

commonly called chest radiographs or 

X-rays) of underground coal miners. The 

revised standards modify the 

requirements to permit the use of filmbased radiography systems and add a 

parallel set of standards permitting the 

use of digital radiography systems. An 

additional amendment requires coal 

mine operators to provide the National 

Institute for Occupational Safety and 

Health (NIOSH) with employee rosters 

to assist the Coal Workers’ Health 

Surveillance Program in improving 

participation by miners. 

DATES: This final rule is effective 

October 15, 2012. The incorporation by 

reference of certain publications listed 

in the rule is approved by the Director 

of the Federal Register as of October 15, 

2012. 

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 final 

rulemaking is organized as follows: 

Table of Contents 

I. Public Participation 

II. Background 

A. Scope of Rulemaking 

B. Impact of Rulemaking 

III. Summary of Final Rule and Response to 

Public Comments 

A. Subpart—Chest Radiographic 

Examinations 

B. Subpart—Autopsies 

IV. Regulatory Assessment Requirements 

A. Executive Orders 12866 and 13563 

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. Final Rule 

I. Public Participation 

HHS received comments from 11 

individuals and organizations. Four of 

the commenters are B Readers; two are 

West Virginia physicians; one is a 

private citizen; and one is a U.S. 

Senator. Comments were also submitted 

on behalf of the National Council on 

Radiation Protection and Measurements 

(NCRP), the American Society of 

Radiologic Technologists, and a law 

firm representing two coal companies 

and the West Virginia Coal Workers’ 

Pneumoconiosis Fund. 

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 coal workers’ pneumoconiosis 

(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)). 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 

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 physicians who are 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. 

HHS proposed amendments to the 

existing part 37 regulations in a 

document published in January, 2012 

(77 FR 1360, January 9, 2012). 

A. 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 remain in effect. This 

rulemaking does not substantially alter 

the current standards. 

Significantly, the new rule expands 

the availability of chest radiographic 

examinations by establishing additional 

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Federal Register / Vol. 77, No. 178 / Thursday, September 13, 2012 / Rules and Regulations 56719 

options for giving, interpreting, 

classifying, and submitting digitallyacquired radiographs under the same 

scope as the existing rule does for film 

radiographs. The final rule establishes 

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 final rule also makes 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 final rule does not modify existing 

requirements for miner radiographic 

examinations, eligibility, or other rights, 

including transfer of affected miners in 

accordance with 30 CFR part 90. 

B. Impact of Rulemaking 

The U.S. Department of Labor (DOL) 

will likely amend its Black Lung 

Benefits Act (BLBA) program 

regulations to correspond with this final 

rule. 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 

enable the use of digital chest images for 

medical surveillance under its 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 include 

requirements for screening asbestosexposed individuals using chest 

radiography. Enabling the use of 

modern digital chest imaging in that 

setting will involve similar technical 

considerations as are addressed in this 

final rule. However, OSHA’s asbestos 

regulations are not linked by statute or 

regulation to this final rule. 

The DOL standards refer to chest 

‘‘roentgenograms,’’ an outdated term 

which NIOSH is replacing with the 

more contemporary ‘‘radiograph.’’ 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 final rule. Finally, the 

DOL standards refer to film-based 

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. 

III. Summary of Final Rule and 

Response to Public Comments 

This final rule establishes new 

requirements for digital radiography 

under existing part 37 of 42 CFR— 

Specifications for Medical Examinations 

of Underground Coal Miners. The new 

provisions supplement and update the 

existing requirements for film-screen 

radiographs by establishing standards 

for digital radiographs. The following is 

a section-by-section introduction to 

each rule section, including a summary 

of the public comments and NIOSH 

responses to them. In general, the 

commenters are supportive of this 

rulemaking and welcome its 

implementation. Commenters offered 

thoughtful and practical suggestions for 

improvement of the final rule text, and 

HHS has adopted many of those 

suggestions. 

Table 1 matches the current 

regulatory provisions with the 

corresponding final provisions. The 

final regulatory text is provided in the 

last section of this notice. 

TABLE 1—CURRENT AND FINAL PROVISIONS

Current regulation Final 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. 

37.10 Standards incorporated by reference. 

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 roentgeno graphic 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 Availability of records. 

37.200 Scope ......................................................................................... 37.200 Scope. 

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56720 Federal Register / Vol. 77, No. 178 / Thursday, September 13, 2012 / Rules and Regulations 

TABLE 1—CURRENT AND FINAL PROVISIONS—Continued 

Current regulation Final regulation 

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. 

HHS received no comments on this 

section. 

Section 37.2 Definitions 

HHS amends a number of terms in the 

existing § 37.2 to reflect updated 

terminology and references. 

Comment: One commenter supports 

and agrees with the definition of 

‘‘radiologic technologist’’ included in 

Section 37.2 but suggests that the 

definition contained in this section be 

amended to require the individual to 

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 registration for 

radiologic technologists in radiography 

offered by the American Registry of 

Radiologic Technologists.’’ The 

definition proposed by HHS would 

make those credentials ‘‘optimal,’’ but 

not required. 

HHS response: HHS considers the 

described training, certification, and 

ongoing renewals as optimum for 

radiologic technologists. However, 

because State and Territorial 

governments have regulatory authority 

for oversight of radiologic technologists, 

the Federal government cannot require 

such credentials. Accordingly, the 

commenter’s suggestion cannot be 

implemented. 

Section 37.3 Chest Radiographs 

Required for Miners 

This existing section requires mine 

operators to provide miners an 

opportunity to receive a chest 

radiograph. HHS amends this provision 

to delete and replace outdated text. HHS 

received no comments on § 37.3. 

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. HHS received 

no comments on § 37.4. 

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). HHS amends this section 

to redact outdated text and to correct 

gender-exclusive language. HHS 

received no comments on § 37.5. 

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. HHS amends this section 

to replace outdated text with current 

terminology. HHS received no 

comments on § 37.6. 

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 another position in an 

area of the mine where the 

concentration of respirable dust in the 

mine atmosphere is in compliance with 

MSHA requirements in 30 CFR 90.3. 

HHS received no comments on § 37.7. 

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. HHS received no 

comments on § 37.8. 

Section 37.10 Standards Incorporated 

by Reference 

HHS has added § 37.10 to consolidate 

all of the standards incorporated by 

reference in Part 37. There are no 

substantive changes to the referenced 

standards. 

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. HHS received no comments on 

§ 37.20. 

Section 37.40 General Provisions 

This existing section outlines general 

provisions for chest radiographic 

examinations. HHS received no 

comments on § 37.40. However, 

paragraph (c) is edited to indicate that 

a radiograph may also be performed by 

a radiologic technologist to comport 

with the requirements in §§ 37.41 and 

37.42. 

Section 37.41 Chest Radiograph 

Specifications—Film 

This existing section establishes 

performance standards for the 

acquisition of chest radiographs using 

film-screen technology. HHS amends 

this section to update terminology and 

standards. In response to comments, 

discussed below, subsection (c) is 

amended to require that chest 

radiographs be performed by either a 

physician or a person working under the 

supervision of a physician, or by a 

radiologic technologist. Subsection (d) 

is amended in response to a comment to 

§ 31.42, below, to specify that the size 

of the focal spot should be described as 

the measured size and not the nominal 

size. Subsection (n) is also amended in 

response to comments (see below) to 

require that each radiograph be marked 

with the miner’s date of birth, in 

addition to the identification of the 

facility where it was made, the miner’s 

Social Security number, and the date on 

which the X-ray was made. 

Comment: One commenter supports 

the change to subsection (c), requiring 

that a radiologic technologist perform 

chest radiography using film. According 

to the commenter, a registered 

radiologic technologist in radiography is 

educationally prepared and clinically 

competent to perform chest 

radiography. Several commenters do not 

approve of the proposed requirement, 

asserting that when radiographs of 

miners under this regulation are taken 

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Federal Register / Vol. 77, No. 178 / Thursday, September 13, 2012 / Rules and Regulations 56721 

by State approved and licensed 

radiology facilities in a physician’s 

office or clinic and that X-ray is 

performed under the direct supervision 

of a facility medical or osteopathic 

physician, it is not necessary to employ 

a radiology technician. Commenters 

state that allowing other trained 

professionals to make radiographs will 

improve the availability of surveillance 

health examination in mining regions. 

HHS response: The intent of the 

wording in this section is to assure that 

coal miners are provided high quality 

radiographic examinations using 

professionally-accepted methods that 

minimize radiation exposure. In order to 

optimize quality, safety, and 

accessibility goals, the wording of 

§ 37.41(c) has been edited to indicate 

that the X-ray may be made either a 

physician or a person working under the 

supervision of a physician, or by a 

radiologic technologist. 

Comment: One commenter states that 

use of Social Security number as an 

identifier is increasingly difficult. The 

individual suggests that for 

examinations under this regulation, the 

image file or DICOM header include the 

date of birth of the individual whose 

chest is imaged. 

HHS response: HHS concurs and has 

accordingly modified the regulatory text 

in § 37.41(n) to require that the X-ray 

also be marked with the miner’s date of 

birth. 

Section 37.42 Chest Radiograph 

Specifications—Digital Radiography 

Systems 

This new section establishes 

performance standards for the 

acquisition of chest radiographs using 

digital radiography systems, including 

digital radiography and computed 

radiography. Section 37.42(b), (c), (d), 

and (i)(4) is amended in response to 

comments, as discussed below. Section 

37.42(i)(5)(i)(A) is amended to include 

DICOM Standard PS 3.3–2001, Annex 

A, Computed Radiography Image 

Information Object Definition. This 

section title was inadvertently omitted, 

and references an image information 

object which was already a required 

component of older CR equipment 

models. 

Comment: One commenter notes that 

the regulations ‘‘do not require 

certification that the individual digital 

image taken both complied with the 

specifications of 42 CFR 37.42 and that 

the facility where the digital image was 

taken has been approved, and that its 

approval was current under 42 CFR 

37.44, when the digital image was 

taken.’’ The comment suggests either the 

recording form be revised or 

alternatively, a web-based listing of 

NIOSH-approved radiographic facilities 

be made available. 

HHS response: CWHSP will continue 

to maintain a web-based listing of 

radiographic facilities that are NIOSHapproved under 42 CFR part 37, 

including directions and maps to locate 

approved facilities. (See, http:// 

www.cdc.gov/niosh.) 

Comment: One commenter indicates 

that the size of the detector specified in 

§ 37.42(b) would exclude one prominent 

equipment provider, and also would 

unnecessarily prohibit use of larger 

detectors. The commenter further 

suggests that the specification of a 5 

megapixel matrix size be eliminated 

since the requirements for pixel pitch 

and detector size are sufficient, and 

these are not entirely consistent with 

the specified matrix size. The 

commenter further expresses concern 

that the requirement that ‘‘Spatial 

resolution shall be at least 2.4 line pair 

per millimeter’’ is not adequately 

defined. The commenter offers several 

methods to clarify the requirement, 

including the suggestion that the 

modulation transfer function be 

included in the system performance 

requirements in § 37.42(i)(4). 

HHS response: In response to this 

comment, the text of the final rule is 

modified to specify only pixel pitch and 

detector size, without a specific matrix 

size. Specifically, HHS has omitted the 

proposed maximum size for image 

detectors. The final rule text now 

specifies a minimum area and width for 

detectors which will accommodate the 

equipment mentioned in the comment 

(§ 37.42(b)). Per the commenter’s 

suggestion, § 37.42(i)(4) is also amended 

to address the modulation transfer 

function (MTF). However, HHS reminds 

stakeholders that under § 37.42(i)(6), 

NIOSH retains the discretion to evaluate 

image quality by requiring the facility to 

include a test object on each X-ray. 

Comment: One commenter states that 

when radiographs of miners under this 

regulation are taken by State-approved 

and licensed radiology facilities in a 

physician’s office or clinic and that Xray is performed under the direct 

supervision of a facility medical or 

osteopathic physician, it is not 

necessary to employ a radiologic 

technologist (§ 37.42(c)). 

HHS Response: In order to optimize 

quality, safety, and accessibility goals, 

the wording of § 37.42(c) has been 

edited to indicate that the X-ray may be 

made by either a physician or a person 

working under the supervision of a 

physician, or by a radiologic 

technologist. 

Comment: A commenter suggests that, 

in relation to the specifications for X-ray 

generators in 37.42(d), the size of the 

focal spot should be described as the 

measured size and not the nominal size. 

HHS response: HHS has amended the 

final rule text to specify the measured, 

rather than nominal width of the focal 

point. A similar change is made to 

§ 37.41(d), specifications for film 

radiographs. 

Comment: One commenter suggests 

that the application of edge 

enhancement techniques in image 

processing may result in inaccurate 

appearances and emphasizes the 

importance of using full uncompressed 

DICOM image files, and requiring 

medical grade monitors (§ 37.42(i)). 

HHS response: HHS concurs with the 

commenter and believes that the 

provisions in § 37.42(i) appropriately 

restrict use of edge enhancement 

techniques, require compression of 

DICOM image files to be fully reversible 

(lossless), and stipulate that the image 

display devices must meet the Grayscale 

Standard Display Function for 

diagnostic monitors specified in DICOM 

Part 14. 

Comment: One commenter 

recommends that § 37.42(i)(5)(ii)(A) be 

amended to require that the image file 

or DICOM header include the date of 

birth of the individual whose chest is 

imaged. Another commenter indicates 

that determining whether imaging 

parameters have been met will be 

difficult because only basic information 

is contained in the DICOM header, thus 

placing a burden on small hospitals 

attempting to comply with quality 

assurance standards. 

HHS response: HHS concurs that the 

miner’s date of birth should be required 

for film radiographs. For digital 

radiographs, unique identification of 

each miner, chest image, facility, and 

date and time of the examination are 

encoded within the image information 

object according to Part 3 (PS 3.3–2009) 

of the DICOM standard, as specified in 

§ 37.42. Accordingly, HHS has not 

amended the text of § 37.42(i)(5)(ii)(A). 

With regard to the quality assurance 

standards, since the inception of the 

Program, there has been a continuing 

concern for both safety and image 

properties, and quality assurance has 

always been a component of the 42 CFR 

Part 37 specifications. In this final rule, 

this professionally recommended and 

prudent element is being extended to 

cover the newly permitted digital 

imaging systems. 

Comment: A commenter expresses 

concern that images will be rejected and 

deleted even if, due to emergency 

situations, patients may be elderly, too 

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56722 Federal Register / Vol. 77, No. 178 / Thursday, September 13, 2012 / Rules and Regulations 

2 International Labour Office [2011]. Guidelines 

for the use of ILO International Classification of 

Pneumoconiosis, revised edition 2011). Geneva, 

Switzerland: International Labour Organization. 

Occupational Safety and Health Series No. 22 (Rev. 

2011). 

ill for a high quality standard PA image, 

etc. The commenter further states that 

all images have useful information, and 

that no images should be discarded 

(§ 37.42(i)(11)). 

HHS response: The rule allows each 

physician reader to maintain his or her 

individual professional judgment in 

determining the quality of an image that 

is to be classified. The rule does not 

specifically require deletion of image 

files, but requires that when an image is 

deemed suboptimal and imaging is 

immediately repeated to obtain a better 

quality image, the original suboptimal 

file be fully deleted or rendered 

permanently inaccessible. The 

requirement to delete image files after 

they are transferred to NIOSH or if 

found substandard and thus 

immediately repeated is entirely 

analogous to the current rules regarding 

destruction of copies of film 

radiographs, and is only intended to 

assure maintenance of worker 

confidentiality for participants in the 

mandated Program. Approved facilities 

are permitted to forward to NIOSH all 

files of chest radiographic examinations 

that they have performed for any 

eligible coal miner, independent of 

image quality. 

Section 37.43 Approval of 

Radiographic Facilities That Use Film 

Section 37.43 comprises the current 

requirements in existing § 37.42— 

Approval of roentgenographic facilities. 

HHS received no comments on § 37.43. 

Section 37.44 Approval of 

Radiographic Facilities That Use Digital 

Radiography Systems 

Section 37.44 establishes standards 

for the approval of radiographic 

facilities that use digital radiography 

systems. These standards mirror those 

for film-screen technology. 

Comment: A commenter states that it 

is the position of the American Society 

of Radiologic Technologists that 

radiographic technique charts be used 

by persons performing radiography and 

that all health care facilities make 

radiographic technique charts available 

to persons performing radiography. The 

commenter is pleased to see this 

position reflected by the inclusion of the 

provision in § 37.44(g)(2) along with the 

requirement that facilities have in place 

a documented quality assurance 

program. 

HHS response: HHS appreciates this 

comment. 

Section 37.45 Protection Against 

Radiation Emitted by Radiographic 

Equipment 

This provision requires that 

radiographic equipment conform to 

applicable State, territorial, and Federal 

regulations. Where no State, Territorial 

or Federal regulations apply, the section 

incorporates by reference the 

recommendations of the National 

Council on Radiation Protection and 

Measurements (NCRP). 

Comment: A commenter representing 

the NCRP provided updated references 

to the publications of his organization 

for the text of the regulation. 

HHS response: HHS appreciates the 

comment and has amended the final 

rule text accordingly. 

Section 37.50 Interpreting and 

Classifying Chest Radiographs—Film 

Procedures for classifying radiographs 

are unchanged from the existing § 37.50, 

but for updating the requirement that 

images be interpreted and classified in 

accordance with the Guidelines for the 

Use of the ILO International 

Classification of Radiographs for 

Pneumoconioses, 2011 edition.2 HHS 

received no comments on § 37.50. HHS 

is changing the rule text in § 37.50(a) 

and (c) to clarify that the Guidelines are 

being incorporated by reference. 

Section 37.51 Interpreting and 

Classifying Chest Radiographs—Digital 

Radiography Systems 

Section 37.51 establishes 

requirements for the classification of 

radiographs. Of note, 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. 

HHS is changing the rule text in 

§ 37.51(b) and (c) to clarify that the 

Guidelines are being incorporated by 

reference. 

Comment: A commenter observes that 

it can be difficult for a reader to load the 

subject images on his or her picture 

archiving and communication (PACS) 

system, due to software issues from the 

system manufacturers. The commenter 

further states that that software in most 

PACS systems does not permit viewing 

of the miner radiograph side-by-side 

with another image folder, such as the 

ILO standard images. 

HHS response: NIOSH is aware of this 

concern, and has applied considerable 

resources and effort to make available a 

specific software package (NIOSH 

BViewer®) which is designed to address 

this issue (the BViewer software is 

available for free download at http:// 

www.cdc.gov/niosh/topics/ 

chestradiography/digital-images.html). 

Although initially it is anticipated that 

some readers may have difficulty in 

displaying the standard ILO images 

along with the miner radiograph, over 

time, NIOSH believes that PACS 

manufacturers will incorporate software 

with functionality similar to B Viewer to 

further ameliorate this concern. 

Section 37.52 Proficiency in the Use of 

Systems for Classifying the 

Pneumoconioses 

This section establishes the A and B 

Reader approval programs, and is 

modified from existing § 37.51 to make 

clarifications in the current 

requirements and update older 

terminology. HHS received no 

comments on § 37.52. 

Section 37.53 Method of Obtaining 

Definitive Interpretations 

Section 37.53 maintains 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 will obtain 

a third interpretation. 

Comment: One commenter indicates 

that if the B Reader feels the image is 

satisfactory for identifying the 

abnormality, then it should not be 

disqualified if quality assurance 

standards have not been met. The 

commenter feels technical issues should 

not be used to disqualify evidence and 

therefore deny benefits if the individual 

is not able to return for repeat testing, 

and suggests that consensus among 2 or 

more B Readers be required where the 

quality of an image is in dispute. 

HHS response: A digital or screen film 

radiograph will not be disqualified for 

technical reasons if two or more B 

Readers do not find it unreadable and 

are able to classify it. The B Reader rates 

the quality of the image and classifies it 

for the presence and severity of findings 

associated with pneumoconiosis, but 

does not assess whether the facility 

making the image complied with the 

quality assurance specifications in Part 

37. The rule does not constrain the 

reader in determining whether the 

image is either satisfactory or 

unreadable due to quality issues. Thus, 

responding to this comment does not 

necessitate a change to the rule text. 

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Federal Register / Vol. 77, No. 178 / Thursday, September 13, 2012 / Rules and Regulations 56723 

Section 37.54 Notification of 

Abnormal Radiographic Findings 

Section 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. As discussed below, 

§ 37.54(b) is amended in response to 

public comment. 

Comment: One commenter believes 

that the side-by-side review referenced 

in § 37.54(b) can be confusing to the 

miner, and that all information 

regarding X-ray results should be 

communicated at one time. The 

commenter suggests that because the 

evaluation of findings other than 

pneumoconiosis does not require a B 

Reader, this section should permit the 

comparisons to be done by any licensed 

physician, and/or that the miner be 

provided with copies of the relevant 

images so that their personal physician 

can perform the comparison. Finally, 

the commenter suggests that 

communication about health issues be 

to the miner, and not the designated 

physician to reduce the chance of 

failure of important communications. 

Another commenter recommends that 

NIOSH utilize available in-house 

medical expertise to complete the ‘‘sideby-side’’ readings. Outside consultation 

could still be obtained, where deemed 

useful or necessary. 

HHS response: HHS agrees with 

commenters that the use of a B Reader 

to interpret findings other than 

pneumoconiosis is unnecessary. In 

response to these comments, HHS has 

amended § 37.54(b) to indicate that, 

instead of a B Reader, NIOSH will 

arrange for a licensed physician to 

compare the most recent image and 

interpretation to older ones and inform 

the miner of any significant changes or 

progression of disease or other 

comments. The rule text is also changed 

to clarify that the Department means to 

refer to abnormal findings other than 

pneumoconiosis and substitutes the 

phrase ‘‘abnormality of cardiac shape or 

size’’ for ‘‘enlarged heart.’’ 

Section 37.60 Submitting Required 

Chest Radiographs and Miner 

Identification Documents 

Section 37.60 is essentially 

unchanged from existing § 37.60, which 

establishes the protocol for submitting 

radiographs. HHS received no 

comments on § 37.60. 

Section 37.70 Review of 

Interpretations 

This section is amended only to 

update terminology. HHS received no 

comments on § 37.70. 

Section 37.80 Availability of Records 

for Radiographs 

Section 37.80 remains unchanged 

from the existing requirement, although 

terminology in this section is updated. 

HHS received no comments on § 37.80. 

Section 37.200 Scope 

Section 37.200 remains unchanged 

from the existing explanation that 

provisions in this subpart establish 

conditions under which pathologists 

will be paid to conduct autopsies on 

deceased miners. HHS received no 

comments on § 37.200. 

Section 37.201 Definitions 

Section 37.201 retains the existing 

definitions for Secretary, miner, and 

pathologist, but updates ‘‘ALFORD,’’ in 

the existing provision to ‘‘NIOSH.’’ HHS 

received no comments on § 37.201. 

Section 37.202 Payment for Autopsy 

Section 37.202 retains the existing 

provision setting forth circumstances 

under which a pathologist may be paid 

by the Secretary for performing an 

autopsy. HHS received no comments on 

§ 37.202. 

Section 37.203 Autopsy Specifications 

Section 37.203 retains the existing 

standards establishing the manner in 

which autopsies are conducted. HHS 

received no comments on § 37.203. 

Section 37.204 Procedure for 

Obtaining Payment 

Section 37.204 retains the existing 

procedure for submitting a claim for 

payment to NIOSH (‘‘NIOSH’’ replaces 

‘‘ALFORD’’ in the rule text). HHS has 

received no comments on § 37.204. 

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 final 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 

(CWHSP) administered by NIOSH under 

42 CFR part 37, in cooperation with coal 

mine operators, to monitor and protect 

the health of U.S. coal miners, 

particularly for the prevention of coal 

workers’ pneumoconiosis. 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 does 

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 

this final rule. 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 an approved 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, it is estimated 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 

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56724 Federal Register / Vol. 77, No. 178 / Thursday, September 13, 2012 / Rules and Regulations 

3U.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 June 26, 2012. 

promulgated, we estimate a first year 

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. HHS 

invited public comment on these 

estimates and received one comment 

asserting that meeting the rule’s quality 

assurance standards will be 

prohibitively expensive for small 

facilities. As discussed here, HHS 

expects that facilities voluntarily 

upgrading to digital technology will 

necessarily incur costs associated with 

acquiring the technology and meeting 

regulatory standards. However, the 

quality assurance standards in this rule 

reflect standard industry practice and 

should not create burdens for small 

facilities already using, or planning to 

use, digital chest imaging and wishing 

to join the CWHSP. 

Furthermore, the final rule does 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 

final rule. 

The provisions for using the DICOM 

standard and incorporating by reference 

standard best practices for digital 

radiography used in lung imaging 

ensure that the final 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 final rule establishes a new 

requirement for coal mine operators to 

provide to NIOSH a roster of current 

miners 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 final rule is not 

considered economically significant, as 

defined in sec. 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 

establishes standards for the delivery of 

digitally-acquired chest radiographs for 

underground coal miners. It does not 

impose any new requirements on small 

radiographic facilities that participate in 

the Coal Workers’ Health Surveillance 

Program (CWHSP) 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 will 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 rule 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 final rule also 

introduces a substantial benefit in 

allowing the participation in CWHSP 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 

CWHSP under part 37. 

This final rule is expected to 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 will 

impose no new costs on small coal mine 

operators. 

The final rule establishes a new 

requirement for coal mine operators to 

provide to NIOSH a roster of current 

miners under § 37.4(a)(3). The provision 

of this roster to NIOSH is current 

practice by almost all coal mine 

operators. HHS estimates that, of 488 

underground coal mines that can be 

considered small as of the first quarter 

of 2011,3 130 coal mine plans are 

submitted to the Agency annually. HHS 

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; 

HHS estimates the annual cost for an 

individual coal 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 HHS’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. HHS 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 final 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 requires 

underground coal mine operators to 

submit a roster of current employees 

(§ 37.4(a)(3)), and the Facility 

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Federal Register / Vol. 77, No. 178 / Thursday, September 13, 2012 / Rules and Regulations 56725 

Certification Document which is 

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. For 2012, the 

inflation adjusted threshold is $139 

million. 

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 final 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. 

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 final rule consistent 

with the Federal Plain Writing Act 

guidelines. 

V. Final 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, Xrays. 

Text of the Rule 

For the reasons discussed in the 

preamble, the Department of Health and 

Human Services amends 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 

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56726 Federal Register / Vol. 77, No. 178 / Thursday, September 13, 2012 / Rules and Regulations 

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 will 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, will 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 that 

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 that specifies the types of cassette, 

intensifying screen, film or digital 

detector, grid, filter, and lists X-ray 

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 

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 must 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 must begin no 

sooner than October 15, 2012 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 that 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 

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its plan a 6-month period within which to 

offer its examinations to its miners employed 

at mine Y. The 6-month period must 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 must 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 must 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 must 

have the opportunity for examinations. 

(b) Mandatory examinations. Every 

operator must 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 must 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) will 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 

must be provided in accordance with a 

plan that 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 must 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 must 

submit a plan within 60 days after such 

event occurs. A separate plan must be 

submitted by the operator and by each 

construction contractor for each 

underground coal mine that has a 

MSHA identification number. The plan 

must 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 

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 must 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 must 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 must 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 

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plan or change in plan must 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 

must 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 must 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 § 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 must specify the ground upon 

which approval is proposed to be 

denied. 

(c) If a plan is denied approval, the 

Secretary must 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 must 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) 

must 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 in 

compliance with the MSHA 

requirements in 30 CFR 90.3. 

* * * * * 

■ 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 that may result from this 

examination will be subject to the terms 

of § 37.7. 

■ 10. Add § 37.10 to read as follows: 

§ 37.10 Standards incorporated by 

reference. 

(a) Certain material is incorporated by 

reference into this part with the 

approval of the Director of the Federal 

Register under 5 U.S.C. 552(a) and 1 

CFR part 51. To enforce any edition 

other than that specified in this section, 

NIOSH must publish notice of change in 

the Federal Register and the material 

must be available to the public. All 

approved material is available for 

inspection at NIOSH, Division of 

Respiratory Disease Studies, 1095 

Willowdale Road, Morgantown, WV 

26505. To arrange for an inspection at 

NIOSH, call 304–285–5749. Copies are 

also available for inspection at the 

National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030 or 

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

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

(b) American Association of 

Physicists in Medicine, Order 

Department, Medical Physics 

Publishing, 4513 Vernon Blvd., 

Madison, WI 53705, http:// 

www.aapm.org/pubs/reports: 

(1) AAPM On-Line Report No. 03, 

Assessment of Display Performance for 

Medical Imaging Systems, April 2005, 

into § 37.51(d) and (e). 

(2) 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, into §§ 37.42(h) 

and 37.44(g). 

(3) 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, July 1990, into 

§ 37.44(g). 

(4) 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, into §§ 37.42(h), 37.43(f), and 

37.44(g). 

(5) AAPM Report No. 93, Acceptance 

Testing and Quality Control of 

Photostimulable Storage Phosphor 

Imaging Systems, October 2006, into 

§§ 37.42(i) and 37.44(g). 

(6) AAPM Report No. 116, An 

Exposure Indicator for Digital 

Radiography, Report of AAPM Task 

Group 116, published by AAPM, July 

2009, into § 37.44(g). 

(c) American College of Radiology, 

1891 Preston White Dr., Reston, VA 

20191, http://www.acr.org/∼/media/ 

ACR/Documents/PGTS/guidelines/ 

Reference_Levels.pdf: 

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Federal Register / Vol. 77, No. 178 / Thursday, September 13, 2012 / Rules and Regulations 56729 

(1) ACR Practice Guideline for 

Diagnostic Reference Levels in Medical 

X-Ray Imaging, Revised 2008 

(Resolution 3), into §§ 37.42(i) and 

37.44(g). 

(2) [Reserved] 

(d) International Labour Office, CH– 

1211 Geneva 22, Switzerland, http:// 

www.ilo.org/publns: 

(1) Guidelines for the Use of the ILO 

International Classification of 

Radiographs of Pneumoconioses, 

Revised Edition 2011, into §§ 37.50(a), 

37.50(c), and 37.51(b). 

(2) [Reserved] 

(e) National Council on Radiation 

Protection and Measurements, NCRP 

Publications, 7910 Woodmont Avenue, 

Suite 400, Bethesda, MD 20814–3095, 

Telephone (800) 229–2652, http:// 

www.ncrppublications.org: 

(1) NCRP Report No. 102, Medical Xray, Electron Beam, and Gamma-Ray 

Protection for Energies Up to 50 MeV 

(Equipment Design, Performance, and 

Use), issued June 30, 1989, into § 37.45. 

(2) NCRP Report No. 105, Radiation 

Protection for Medical and Allied 

Health Personnel, issued October 30, 

1989, into § 37.45. 

(3) NCRP Report No. 147, Structural 

Shielding Design for Medical X-Ray 

Imaging Facilities, revised March 18, 

2005, into § 37.45. 

(f) National Electrical Manufacturers 

Association, 1300 N. 17th Street, 

Rosslyn, VA 22209, http:// 

medical.nema.org: 

(1) DICOM Standard PS 3.3–2011, 

Digital Imaging and Communications in 

Medicine (DICOM) standard, Part 3: 

Information Object Definitions, 

copyright 2011, into § 37.42(i). 

(2) DICOM Standard PS3.4–2011, 

Digital Imaging and Communications in 

Medicine (DICOM) standard, Part 4: 

Service Class Specifications, copyright 

2011, into § 37.42(i). 

(3) DICOM Standard PS 3.10–2011, 

Digital Imaging and Communications in 

Medicine (DICOM) standard, Part 10: 

Media Storage and File Format for 

Media Interchange, copyright 2011, into 

§ 37.42(i). 

(4) DICOM Standard PS 3.11–2011, 

Digital Imaging and Communications in 

Medicine (DICOM) standard, Part 11: 

Media Storage Application Profiles, 

copyright 2011, into § 37.42(i). 

(5) DICOM Standard PS 3.12–2011, 

Digital Imaging and Communications in 

Medicine (DICOM) standard, Part 12: 

Media Formats and Physical Media for 

Media Interchange, copyright 2011, into 

§§ 37.42(i) and 37.44(a). 

(6) DICOM Standard PS 3.14–2011, 

Digital Imaging and Communications in 

Medicine (DICOM) standard, Part 14: 

Grayscale Standard Display Function, 

copyright 2011, into §§ 37.42(i)(5) and 

37.51(d). 

(7) DICOM Standard PS 3.16–2011, 

Digital Imaging and Communications in 

Medicine (DICOM) standard, Part 16: 

Content Mapping Resource, copyright 

2011, § 37.42(i). 

■ 11. 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 must 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. 

■ 12. Revise the undesignated center 

heading and § 37.40 to read as follows: 

Specifications for Performing Chest 

Radiographic Examinations 

§ 37.40 General provisions. 

(a) The chest radiographic 

examination must 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 must 

be made in a facility approved in 

accordance with § 37.43 or § 37.44. 

Chest radiographs of miners under this 

section must be performed: 

(1) 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; or 

(2) By a radiologic technologist as 

defined in § 37.2. 

■ 13. 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 must be disrobed from the 

waist up at the time the radiograph is 

given. The facility must provide a 

dressing area and for those miners who 

wish to use one, the facility will provide 

a clean gown. Facilities must be heated 

to a comfortable temperature. 

(b) Every chest radiograph must 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 must 

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 must 

include both apices with minimum loss 

of the costophrenic angle. 

(c) Chest radiographs of miners under 

this section must be performed: 

(1) 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; or 

(2) By a radiologic technologist as 

defined in § 37.2. 

(d) Radiographs must be made with a 

diagnostic X-ray machine with a 

maximum actual (not nominal) source 

(focal spot) of 2 mm, as measured in two 

orthogonal directions. 

(e) Except as provided in this 

paragraph (e), radiographs must be 

made with units having generators that 

comply with the following: 

(1) The generators of existing 

radiographic units acquired by the 

examining facility prior to July 27, 1973, 

must have a minimum rating of 200 mA 

at 100 kVp; 

(2) Generators of units acquired 

subsequent to that date must have a 

minimum rating of 300 mA at 125 kVp. 

(f) Radiographs made with batterypowered mobile or portable equipment 

must 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. 

(h) Radiographs must be given only 

with equipment having a beam-limiting 

device that does not cause large 

unexposed boundaries. The beam 

limiting device must provide 

rectangular collimation and must be of 

the type described in 21 CFR 

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

such a device must be discernible from 

an examination of the radiograph. 

(i) To ensure high quality chest 

radiographs: 

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56730 Federal Register / Vol. 77, No. 178 / Thursday, September 13, 2012 / Rules and Regulations 

(1) The maximum exposure time must 

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 must 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, that 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 must 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 must be used. 

(k) Before the miner is advised that 

the examination is concluded, the 

radiograph must 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 must 

be immediately made. All substandard 

radiographs must 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)(1) Each radiograph made 

hereunder must be permanently and 

legibly marked with: 

(i) The name and address or NIOSH 

approval number of the facility at which 

it is made; 

(ii) The miner’s Social Security 

number; 

(iii) The miner’s date of birth; and 

(iv) The date of the radiograph. 

(2) No other identifying markings may 

be recorded on the radiograph. 

§§ 37.42 and 37.43 [Redesignated as 

§§ 37.43 and 37.45] 

■ 14a. Redesignate § 37.42 and § 37.43 

as § 37.43 and § 37.45 respectively. 

■ 14b. Add new § 37.42 to read as 

follows: 

§ 37.42 Chest radiograph specifications— 

digital radiography systems. 

(a) Miners must be disrobed from the 

waist up at the time the radiograph is 

given. The facility must provide a 

private dressing area and for those 

miners who wish to use one, the facility 

must provide a clean gown. Facilities 

must be heated to a comfortable 

temperature. 

(b) Every digital chest radiograph 

taken as required under this section 

must be a single posteroanterior 

projection at full inspiration on a digital 

detector with sensor area being no less 

than 1505 cm square centimeters with a 

minimum width of 35cm. The imaging 

plate must have a maximum pixel pitch 

of 200mm, with a minimum bit depth of 

10. Spatial resolution must be at least 

2.5 line pairs per millimeter. The 

storage phosphor cassette or digital 

image detector must 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 sideby-side images can be obtained that 

together include the apices and the 

costophrenic angles of both right and 

left lungs. 

(c) Chest radiographs of miners under 

this section must be performed: 

(1) 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; or 

(2) By a radiologic technologist as 

defined in § 37.2. 

(d) Radiographs must be made with a 

diagnostic X-ray machine with a 

maximum actual (not nominal) source 

(focal spot) of 2 mm, as measured in two 

orthogonal directions. 

(e) Radiographs must be made with 

units having generators which have a 

minimum rating of 300 mA at 125 kVp. 

Exposure kilovoltage must be at least 

the minimum as recommended by the 

manufacturer for chest radiography. 

(f) An electric power supply must be 

used that 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 

must be used as recommended. 

(g) Radiographs must be obtained only 

with equipment having a beam-limiting 

device that does not cause large 

unexposed boundaries. The beam 

limiting device must 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 must not be 

used. The use and effect of the beam 

limiting device must be discernible on 

the resulting image. 

(h) Radiographic technique charts 

must 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 must be 

documented by a medical physicist 

utilizing the image capture systems and 

exposure parameters used at the facility 

for chest imaging, using methods 

recommended in AAPM Report No. 74, 

pages 17–18, and in AAPM Report No. 

14, pages 61–62 (incorporated by 

reference, see § 37.10). 

(2) Exposure parameters achieved 

during the evaluation of the automated 

exposure system must 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 must 

not exceed 50 milliseconds except for 

subjects with chests over 28 centimeters 

posteroanterior, for whom the exposure 

time must not exceed 100 milliseconds; 

(2) The distance from source or focal 

spot to detector must be at least 70 

inches (or 180 centimeters if measured 

in centimeters); 

(3) The exposure setting for chest 

images must be within the range of 100– 

300 equivalent exposure speeds and 

must comply with 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 (incorporated by reference, see 

§ 37.10). 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 resolution, 

modulation transfer function (MTF), 

image signal-to-noise and detective 

quantum efficiency must be evaluated 

and judged acceptable by a qualified 

medical physicist using the 

specifications in AAPM Report No. 93, 

pages 1–68 (incorporated by reference, 

see § 37.10). Image management 

software and settings for routine chest 

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Federal Register / Vol. 77, No. 178 / Thursday, September 13, 2012 / Rules and Regulations 56731 

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. 

imaging must be used, including routine 

amplification of digital detector signal 

as well as standard image postprocessing functions. Image or edge 

enhancement software functions must 

not 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 may be 

employed. 

(5)(i) The image object, transmission 

and associated data storage, file format, 

and transmission of associated 

information must conform to the 

following components of the Digital 

Imaging and Communications in 

Medicine (DICOM) standard 

(incorporated by reference, see § 37.10): 

(A) DICOM Standard PS 3.3–2011, 

Annex A—Composite Information 

Object Definitions, sections: Computed 

Radiography Image Information Object 

Definition; Digital X-Ray Image 

Information Object Definition; X-Ray 

Radiation Dose SR Information Object 

Definition; and Grayscale Softcopy 

Presentation State Information Object 

Definition. 

(B) DICOM Standard PS3.4–2011, 

Annex B—Storage Service Class; Annex 

N—Softcopy Presentation State Storage 

SOP Classes; Annex O—Structured 

Reporting Storage SOP Classes. 

(C) DICOM Standard PS 3.10–2011. 

(D) DICOM Standard PS 3.11–2011 

(E) DICOM Standard PS 3.12–2011. 

(F) DICOM Standard PS 3.14–2011. 

(G) DICOM Standard PS 3.16–2011. 

(ii) Identification of each miner, chest 

image, facility, date and time of the 

examination must be encoded within 

the image information object, according 

to DICOM Standard PS 3.3–2011, 

Information Object Definitions, for the 

DICOM ‘‘DX’’ object. If data 

compression is performed, it must be 

lossless. Exposure parameters (kVp, mA, 

time, beam filtration, scatter reduction, 

radiation exposure) must be stored in 

the DX information object. 

(iii) Exposure parameters as defined 

in the DICOM Standard PS 3.16–2011 

must 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 must 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 must be used; grids 

must not be used that cause Moire ́

interference patterns in either horizontal 

or vertical images. 

(9) The geometry of the radiographic 

system must 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 must 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 must 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 must 

be made immediately. Unacceptable 

digital image files must 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). 

■ 15. 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 must 

also submit a radiograph of a plastic 

step-wedge object 1 or other test object 

(available on loan from NIOSH) that 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 must have been 

made with each unit to be used 

hereunder. All radiographs must have 

been made within 15 calendar days 

prior to submission and must 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 must 

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 

must 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 (incorporated by 

reference, see § 37.10); 

(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 must 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 must be 

displayed on the mine bulletin board 

adjacent to the operator’s approved 

plan. The approved plan will be 

reevaluated by NIOSH in light of this 

change. 

(f) A formal written quality assurance 

program must be established at each 

facility addressing radiation exposures, 

equipment maintenance, and image 

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56732 Federal Register / Vol. 77, No. 178 / Thursday, September 13, 2012 / Rules and Regulations 

quality, and must conform to the 

standards in AAPM Report No. 74, 

pages 1–19, 47–53, and 56 (incorporated 

by reference, see § 37.10). 

(g) In conducting medical 

examinations pursuant to this Part, 

physicians and radiographic facilities 

must 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. 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 must 

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 that are 

of acceptable quality to one or more 

individuals selected by NIOSH from the 

panel of B Readers and a qualified 

medical physicist or consultant, both 

designated by NIOSH. Image files must 

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 PS 3.12–2011 (incorporated by 

reference, see § 37.10). Applicants will 

be advised of any reasons for denial of 

approval. All submitted images must 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 must 

have been made with each digital 

radiographic unit to be used by the 

facility under the requested approval. 

The corresponding radiographic image 

files must be submitted on standard 

portable media (compact or digital video 

disc) and formatted to meet 

specifications of the current DICOM 

Standard PS 3.12–2011. Documentation 

must 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 must 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 

must 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 

must 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 must 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 section 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 must have been made 

within 1 year prior to the date of 

submission of the application. 

(b) Facilities must 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 must 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. 

(e) A qualified medical physicist who 

is familiar with the facility hardware 

and software systems for image 

acquisition, manipulation, display, and 

storage, must be on site or available as 

a consultant. The physicist must be 

trained in evaluating the performance of 

radiographic equipment and facility 

quality assurance programs, and must 

be licensed/approved by a State or 

Territory of the United States or 

certified by a competent U.S. national 

board. 

(f) Facilities must 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 must be established at each 

facility addressing radiation exposures, 

equipment maintenance, and image 

quality, and must conform to the 

standards in AAPM Report No. 74, 

pages 1–19, 47–53, and 56, and AAPM 

Report No. 116, sections VIII, IX, and X 

(incorporated by reference, see § 37.10). 

(1) Applications for facility approval 

must 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 must comply with the 

following guidelines: AAPM Report No. 

93, pages 1–68; AAPM Report No. 74, 

pages 6–11; and AAPM Report No. 14, 

pages 1–96 (incorporated by reference, 

see § 37.10). 

(2) Radiographic technique charts 

must 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 must 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 must be monitored at least 

quarterly to detect and correct potential 

dose creep, using methods specified in 

AAPM Report No. 31 (incorporated by 

reference, see § 37.10). Radiation 

exposures must be compared to a 

professionally accepted reference level 

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Federal Register / Vol. 77, No. 178 / Thursday, September 13, 2012 / Rules and Regulations 56733 

published in the American College of 

Radiology (ACR) Practice Guideline for 

Diagnostic Reference Levels in Medical 

X-Ray Imaging, pages 1–6 (incorporated 

by reference, see § 37.10). In addition, 

the medical physicist must 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 must be 

monitored annually in accordance with 

the recommendations of AAPM Report 

No. 93 (incorporated by reference, see 

§ 37.10), except for the testing 

specifically excluded below. 

Documentation must 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 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 must 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 

must 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). 

■ 17. 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, must 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 must 

conform to the recommendations in 

NCRP Report No. 102, NCRP Report No. 

105, and NCRP Report No. 147 

(incorporated by reference, see § 37.10). 

■ 18. 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 must be 

interpreted and classified in accordance 

with the Guidelines for the Use of the 

ILO International Classification of 

Radiographs of Pneumoconioses 

(incorporated by reference, see § 37.10). 

Chest radiograph interpretations and 

classifications must be recorded on a 

paper or electronic Roentgenographic 

Interpretation Form (Form CDC/NIOSH 

(M)2.8). 

(b) Radiographs must 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) must 

be provided by a qualified physician 

who has all required licensure and 

privileges, and interprets chest 

radiographs in the normal course of 

practice. 

(2) [Reserved] 

(c) All interpreters, whenever 

interpreting chest radiographs made 

under the Act, must have immediately 

available for reference a complete set of 

the standard radiographs for use with 

the Guidelines for the Use of the ILO 

International Classification of 

Radiographs of Pneumoconioses 

(incorporated by reference, see § 37.10). 

(d) In all view boxes used for making 

interpretations: 

(1) Fluorescent lamps must be 

simultaneously replaced with new 

lamps at 6-month intervals; 

(2) All the fluorescent lamps in a 

panel of boxes must have identical 

manufacturer’s ratings as to intensity 

and color; 

(3) The glass, internal reflective 

surfaces, and the lamps must be kept 

clean; 

(4) The unit must be so situated as to 

minimize front surface glare. 

§§ 37.51 through 37.53 [Redesignated as 

§§ 37.52 through 37.54] 

■ 19a. Redesignate § 37.51 through 

§ 37.53 as § 37.52 through § 37.54 

respectively. 

■ 19b. 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 must provide an initial clinical 

interpretation and notification, as 

specified in § 37.54, of any significant 

abnormal findings other than 

pneumoconiosis. 

(b) Chest radiographs must 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 Guidelines for the Use of the 

ILO International Classification of 

Radiographs of Pneumoconioses 

(incorporated by reference, see § 37.10). 

Chest radiograph interpretations and 

classifications must 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, must 

have immediately available for reference 

a complete set of NIOSH-approved 

standard digital chest radiographic 

images provided for use with the 

Guidelines for the Use of the ILO 

International Classification of 

Radiographs of Pneumoconioses 

(incorporated by reference, see § 37.10). 

Only NIOSH-approved standard digital 

images may 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)(i) Image display devices must be 

flat panel monitors displaying at least 3 

MP at 10 bit depth. Image displays and 

associated graphics cards must meet the 

calibration and other specifications of 

the Digital Imaging and 

Communications in Medicine (DICOM) 

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56734 Federal Register / Vol. 77, No. 178 / Thursday, September 13, 2012 / Rules and Regulations 

2NIOSH Safety and Health Topic. Chest 

Radiography: Radiographic Classification [http:// 

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

radiographic-classification.html]. Date accessed: 

June 27, 2012. 

standard PS 3.14–2011 (incorporated by 

reference, see § 37.10). 

(ii) Image displays and associated 

graphics cards must not deviate by more 

than 10 percent from the grayscale 

standard display function (GSDF) when 

assessed according to the AAPM OnLine Report No. 03, pages 1–146 

(incorporated by reference, see § 37.10). 

(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, pages 

1–146 (incorporated by reference, see 

§ 37.10). Viewing displays must 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, must be 

included in luminance measurements. 

(3) Displays must be situated so as to 

minimize front surface glare. Readers 

must 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 must be taken 

using calibrated software measuring 

tools. If permitted by the viewing 

software, a record must 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 must comply with the 

recommendations of the American 

Association of Physicists in Medicine 

AAPM On-Line Report No. 03, pages 1– 

146 (incorporated by reference, see 

§ 37.10). 

(1) If automatic quality assurance 

systems are used, visual inspection 

must 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 must be performed based 

on the viewing of images displayed as 

soft copies using the viewing 

workstations specified in this section. 

Classification of radiographs must not 

be based on the viewing of hard copy 

printed transparencies of images that 

were digitally-acquired. 

(g) The classification of chest 

radiographs based on digitized copies of 

chest radiographs that were originally 

acquired using film-screen techniques is 

not permissible under this part. 

■ 20. 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 must 

continue if established prior to October 

15, 2012. 

(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 

must 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 

must 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, is hereby 

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 

must 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 must 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). 

■ 21. 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 

will be considered final and reported to 

MSHA for transmittal to the miner. 

When agreement is lacking, NIOSH 

must obtain a third interpretation from 

the panel of B Readers. If any two of the 

three interpretations demonstrate 

agreement, the result must 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 must 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 must 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. 

■ 22. Revise newly designated § 37.54 to 

read as follows: 

§ 37.54 Notification of abnormal 

radiographic findings. 

(a) Findings of, or findings suggesting, 

abnormality of cardiac shape or size, 

tuberculosis, lung cancer, or any other 

significant abnormal findings other than 

pneumoconiosis must be communicated 

by the first physician to interpret the 

radiograph to the miner indicated on the 

Miner Identification Document or to the 

miner’s designated physician. A notice 

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Federal Register / Vol. 77, No. 178 / Thursday, September 13, 2012 / Rules and Regulations 56735 

of the communication must be 

submitted to NIOSH. When significant 

abnormal findings are reported, NIOSH 

will also notify the miner to contact his 

or her physician. 

(b) In addition, when NIOSH has 

more than one radiograph of a miner in 

its files and the most recent examination 

was found by the first physician to 

interpret the radiograph or subsequently 

by NIOSH B Readers to show an 

abnormality of cardiac shape or size, 

tuberculosis, cancer, complicated 

pneumoconiosis, and any other 

significant abnormal findings, NIOSH 

will arrange for a licensed physician to 

compare the most recent image and 

interpretation to older images and 

NIOSH will inform the miner of any 

significant changes or progression of 

disease or other findings. 

(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 

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. 

■ 23. 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, must 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, must 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 must 

promptly make appropriate 

arrangements for the necessary 

reexamination. 

(c) Failure to comply with paragraph 

(a) or (b) of this section will be cause to 

revoke approval of a plan or any other 

approval as may be appropriate. An 

approval that 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 must be submitted 

only for miners. 

* * * * * 

■ 24. 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 must 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 must 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. 

■ 25. 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. 

■ 26. 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. 

■ 27. 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. 

■ 28. 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 must be submitted to NIOSH 

and must 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: August 28, 2012. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2012–22253 Filed 9–12–12; 8:45 am] 

BILLING CODE 4150–18–P 

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