[Federal Register Volume 77, Number 5 (Monday, January 9, 2012)]
[Proposed Rules]
[Pages 1360-1385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-33164]



[[Page 1359]]

Vol. 77

Monday,

No. 5

January 9, 2012

Part VI





Department of Health and Human Services





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42 CFR Part 37





Specifications for Medical Examinations of Underground Coal Miners; 
Proposed Rule

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 37

[Docket No. CDC-2011-0013; NIOSH-225]
RIN 0920-AA21


Specifications for Medical Examinations of Underground Coal 
Miners

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: With this notice of proposed rulemaking, the Department of 
Health and Human Services (HHS) proposes to modify its regulations on 
Specifications for Medical Examinations of Underground Coal Miners. 
Existing regulations establish specifications for providing, 
interpreting, classifying, and submitting film-based roentgenograms 
(now commonly called chest radiographs or X-rays) of underground coal 
miners for the surveillance of coal workers' pneumoconiosis (black 
lung) under the Coal Workers' Health Surveillance Program, administered 
by the National Institute for Occupational Safety and Health (NIOSH). 
The current standards specify requirements that permit the use of film-
based radiography systems only; proposed amendments would retain those 
standards (with minor modifications that reflect more commonly-used 
terms) and add a parallel set of standards to specify requirements that 
would permit the use of digital radiography systems. An additional 
proposed amendment would require coal mine operators to provide NIOSH 
with employee rosters to assist the Program in improving participation 
by miners.

DATES: Comments must be received by March 9, 2012.

ADDRESSES: You may submit comments, identified by ``RIN 0920-AA21,'' by 
any of the following methods:
     Internet: Access the Federal e-rulemaking portal at http://www.regulations.gov. Follow the instructions for submitting comments.
     Email: NIOSH Docket Officer, [email protected]. Include 
``RIN 0920-AA21'' and ``42 CFR 37'' in the subject line of the message.
     Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
    Instructions: All submissions received must include the agency name 
and docket number or Regulation Identifier Number (RIN) for this 
rulemaking. All relevant comments will be posted without change to 
http://www.regulations.gov including any personal information provided. 
For detailed instructions on submitting comments and additional 
information on the rulemaking process, see the ``Public Participation'' 
heading of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov or http://www.cdc.gov/niosh/docket/NIOSHdocket0225.html.

FOR FURTHER INFORMATION CONTACT: Anita Wolfe, Public Health Analyst, 
Division of Respiratory Disease Studies, National Institute for 
Occupational Safety and Health, 1095 Willowdale Road, MS B208, 
Morgantown, WV, 26505, Telephone (888) 480-4042 (this is a toll-free 
number). Information requests can also be submitted by email to 
[email protected].

SUPPLEMENTARY INFORMATION: The preamble to this notice of proposed 
rulemaking is organized as follows:

Table of Contents

I. Public Participation
II. Background
    A. Need for Rulemaking
    B. Scope of Rulemaking
    C. Impact of Rulemaking
III. Summary of Proposed Rule
    A. Subpart--Chest Radiographic Examinations
    B. Subpart--Autopsies
IV. Regulatory Assessment Requirements
    A. Executive Order 12866
    B. Regulatory Flexibility Act
    C. Paperwork Reduction Act
    D. Small Business Regulatory Enforcement Fairness Act
    E. Unfunded Mandates Reform Act of 1995
    F. Executive Order 12988 (Civil Justice)
    G. Executive Order 13132 (Federalism)
    H. Executive Order 13045 (Protection of Children From 
Environmental Health Risks and Safety Risks)
    I. Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use)
    J. Plain Writing Act of 2010
V. Proposed Rule

I. Public Participation

    Interested persons or organizations are invited to participate in 
this rulemaking by submitting written views, arguments, 
recommendations, and data. Comments are invited on any topic related to 
this proposal. In addition, HHS invites comments specifically on the 
following questions related to this rulemaking:
    (1) Does the current scientific evidence support the assertion that 
the application of digital chest imaging can be equivalent to film-
screen radiography, if appropriate equipment, procedures, and methods 
are applied, in meeting the objectives of the Coal Workers' Health 
Surveillance Program mandated by 30 U.S.C. 843?
    (2) Is there evidence that the proposed specifications for 
equipment, personnel, procedures, and methods will not be adequate to 
assure that the application of digital chest imaging will be equivalent 
to film-screen radiography in meeting the objectives of the Coal 
Workers' Health Surveillance Program? What specific changes are needed 
to ensure equivalence and what is the evidence supporting those 
changes?
    (3) Is there evidence that any element of the specifications will 
not be feasible (for technological or financial reasons) for a 
significant proportion of the digital radiology facilities in coal 
mining regions? If yes, what changes in the specifications for 
equipment, personnel, procedures, and/or methods can improve 
feasibility while continuing to ensure the equivalence of digital chest 
imaging to film-based chest imaging for accurately detecting occurrence 
and progression of coal workers' pneumoconiosis (CWP) among coal 
miners?

II. Background

    All mining work generates fine particles of dust in the air. Coal 
miners who inhale excessive dust are known to develop a group of 
diseases of the lungs and airways, including chronic bronchitis, 
emphysema, chronic obstructive pulmonary disease, silicosis, and 
CWP.\1\ To address such threats to the U.S. coal mining workforce, the 
Coal Mine Health and Safety Act was enacted in 1969 (Pub. L. 91-173) 
and amended by the Federal Mine Safety and Health Act of 1977 (Pub. L. 
95-164, 30 U.S.C. 801 et seq.) (Mine Act). The statutes included an 
enforceable 2 milligrams per cubic meter limit on respirable dust 
exposure during underground coal mine work (30 U.S.C. 842(b)(2)).\2\ 
The science available at that time indicated that enforcement of this 
limit would greatly reduce the development of CWP, but could not ensure 
that all miners would be protected from developing disabling or lethal 
disease.
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    \1\ Petsonk 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.
    \2\ The Mine Safety and Health Administration (MSHA) has 
recently published a notice of proposed rulemaking that seeks to 
lower the existing exposure limit from 2.0 mg/m\3\ to 1.0 mg/m\3\ 
(75 FR 64412, October 19, 2010).
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    The NIOSH Coal Workers' Health Surveillance Program (CWHSP), also

[[Page 1361]]

mandated by the Mine Act, was developed to detect CWP and prevent 
progression in individual miners, while at the same time providing 
information for evaluation of temporal and geographic trends in 
pneumoconiosis. The Mine Act grants NIOSH general authority to issue 
regulations as the Institute deems appropriate in carrying out 
provisions of the Act and specifically directs that medical 
examinations for underground coal miners shall be given in accordance 
with specifications prescribed by NIOSH (30 U.S.C. 843(a), 957).
    To inform each miner of his or her health status, the Act requires 
that underground coal mine operators offer new workers a chest 
roentgenogram (hereafter chest radiograph or X-ray) through an approved 
facility as soon as possible after employment starts. Three years later 
a miner must be offered a second chest radiograph. If this second 
examination reveals evidence of pneumoconiosis, the miner is entitled 
to a third chest radiograph 2 years after the second. Further, all 
miners working in an underground coal mine must be offered a chest 
radiograph approximately every 5 years. All chest radiographs are to be 
given in accordance with specifications prescribed by the Secretary of 
Health and Human Services (30 U.S.C. 843(a)).
    Chest radiographs taken for the CWHSP are assessed by qualified and 
licensed physician A or B Readers. A Readers are physicians who 
interpret chest radiographs for clinical purposes. They will have 
demonstrated knowledge of the International Labour Office (ILO) 
Classification of Radiographs of Pneumoconioses by completing a NIOSH-
approved course or submitting six radiographs with satisfactory 
classifications, as specified in 42 CFR 37.51.
    B Readers are physicians who have demonstrated proficiency in the 
use of the ILO classification system by taking and passing a specially-
designed proficiency examination offered by NIOSH, as specified in 42 
CFR 37.51. The NIOSH B Reader Program aims to ensure competency in the 
detection of pneumoconiosis by evaluating the ability of readers to 
classify a test set of radiographs, thereby creating and maintaining a 
pool of qualified readers having the skills and ability to provide 
accurate and precise classifications in accordance with ILO 
standards.\3\ The B Reader examination currently offered by NIOSH 
consists of the classification of 125 chest radiographs over the course 
of 6 hours; the test addresses proficiency in classification of small 
opacities, large opacities, pleural abnormalities, and certain other 
abnormalities that may appear in the lung radiographs.
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    \3\ International Labour Office [2011]. Guidelines for the use 
of ILO International Classification of Pneumoconiosis, revised 
edition 2011. Geneva, Switzerland: International Labour Office. 
Occupational Safety and Health Series No. 22 (Rev. 2011).
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    B Readers participate in national pneumoconiosis programs directed 
at coal miners and others who suffer from dust-related illness, and are 
also involved with epidemiologic evaluations, surveillance, and worker 
monitoring programs involving many types of pneumoconioses. In applying 
the ILO Classification, B Readers compare sets of standard images, 
which represent different types of abnormalities and levels of disease 
severity, with images of the individual being evaluated to identify 
parenchymal abnormalities (small and large opacities), pleural changes, 
and other features associated, or sometimes confused, with occupational 
lung disease. In the current ILO Classification, the B Reader is first 
asked to grade film quality and is then asked to categorize small 
opacities according to their presence, shape and size, location, and 
profusion. Large opacities are classified according to their presence 
and size. The B Reader also assesses the presence, location, width, 
extent, and degree of calcification of pleural abnormalities.\4\
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    \4\ NIOSH [2007]. Roentgenographic Interpretation Form [http://www.cdc.gov/niosh/topics/surveillance/ords/pdfs/CWHSP-ReadingForm-2.8.pdf]. Date accessed: January 5, 2011.
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    Under NIOSH supervision (see 42 CFR 37.53, as amended, below), a 
summary report based upon the readings of the periodic chest radiograph 
is sent to each participating coal miner, who then has the opportunity 
to take action to reduce further dust exposure if early dust-induced 
lung disease is detected. Miners with evidence of pneumoconiosis have 
specific rights to transfer to jobs with lower dust levels under 30 CFR 
part 90 (see also 42 CFR 37.7). The combined results of these 
radiographic examinations of miners (radiographic surveillance) also 
enable NIOSH to track rates and patterns of CWP among the participating 
miners, so as to evaluate whether the implemented dust controls are 
effective in controlling CWP.

A. Need for Rulemaking

    One goal of the Mine Act is to ensure that respirable dust 
concentrations in underground coal mines are sufficiently low to permit 
each miner the opportunity to be employed underground for a working 
lifetime without incurring any disability from pneumoconiosis or any 
other occupational lung disease (30 U.S.C. 841(b)). Mine operators use 
primary prevention to accomplish this health outcome objective; that 
is, they implement procedures for recognizing, controlling, and 
monitoring exposures to hazardous conditions.
    However, because primary prevention measures may not be fully 
effective, secondary measures are recommended as a means to further 
protect workers. Secondary prevention involves ongoing miner health 
monitoring to recognize abnormalities early so that the miner has the 
necessary information to take appropriate action to prevent disease 
progression. Monitoring data are also periodically reviewed and 
analyzed to evaluate whether the primary preventive measures have been 
effective. This review permits the identification of work processes, 
exposures, or hazardous situations that require better control. 
Secondary prevention is particularly important when a risk to health 
remains in spite of adherence to recommended or permissible exposure 
levels, as has been demonstrated for coal miners.\5\
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    \5\ NIOSH [1995]. Criteria for a recommended standard: 
Occupational exposure to respirable coal mine dust. Cincinnati, 
Ohio: U.S. Department of Health and Human Services, Centers for 
Disease Control and Prevention, National Institute for Occupational 
Safety and Health, DHHS (NIOSH) Publication No. 95-106.
     See also NIOSH [2010]. A review of information published since 
1995 on coal mine dust exposures and associated health outcomes. 
NIOSH Docket Number 210 [http://www.cdc.gov/niosh/docket/review/docket210/]. Date accessed: January 5, 2011.
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    Chest radiography has historically been a valuable tool for 
monitoring the health of coal miners and other individuals potentially 
exposed to fibrogenic dusts such as silica or asbestos. Early changes 
due to pneumoconiosis are frequently identifiable on a high quality 
chest radiograph before an individual would otherwise seek medical 
attention. Over the years, methods for acquiring and interpreting film-
screen chest radiographs have been continuously refined, to enhance the 
accuracy and usefulness of this technique as part of comprehensive 
occupational health protection programs. However, over the past decade 
digital radiography systems have been progressively replacing 
traditional analog film-based radiography for chest imaging.\6\
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    \6\ NIOSH [2008]. Application of the ILO International 
Classification of Radiographs of Pneumoconioses to Digital Chest 
Radiographic Images: A NIOSH Scientific Workshop. Cincinnati, OH: 
U.S. Department of Health and Human Services, Public Health Service, 
Centers for Disease Control and Prevention, National Institute for 
Occupational Safety and Health. DHHS (NIOSH) Publication No. 2008-
139.

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[[Page 1362]]

    In order to retain the recognized benefits of radiographic health 
monitoring as a preventive health measure that is easily accessible by 
dust-exposed workers, it is necessary to require that underground coal 
mine operators furnish NIOSH with a current roster of miners' names and 
addresses. CWHSP has found that directly contacting coal miners who are 
due for a chest examination results in a higher number of miners who 
participate in the Program. In 1990, NIOSH responded to declining 
underground coal miner participation in the Program by obtaining work 
rosters for contact information and sending notifications of 
availability of chest X-ray surveillance directly to the miners. Over 
the next few years, this led to increased participation in the 
Program.\7\ Coal miners themselves have indicated that they would 
prefer to receive a letter from CWHSP at their residence, rather than 
being notified by their employer, because they feel that direct contact 
with the Program provides them greater confidentiality. Also, in the 
experience of CWHSP, the increased family involvement that follows from 
receipt of a letter at home improves Program participation. Almost all 
underground coal mine operators (approximately 505 establishments \8\) 
provide CWHSP with a roster of employees. The rare instance of an 
operator refusing to comply with the request resulted in no coal miners 
employed by a non-compliant operator participating in the Program. 
NIOSH is concerned that further noncompliance with CWHSP's request will 
lead to lower rates of participation in the Program, and result in 
higher rates of pneumoconiosis. An alternative to the roster 
requirement--asking the mines to post Program information on a bulletin 
board in the mine--has been found to be ineffective and has not 
resulted in the same level of participation that has been demonstrated 
by direct mailings.
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    \7\ See Work-Related Lung Disease (WoRLD) Surveillance System, 
Volume 1: Coal Workers' Pneumoconiosis: Morbidity, Table 2012. 
CWXSP: Number and percentage of examined underground miners with 
coal workers' pneumoconiosis (ILO category 1/0+) by tenure, 1970-
2009, http://www2a.cdc.gov/drds/WorldReportData/FigureTableDetails.asp?FigureTableID=2550&GroupRefNumber=T02-12. 
Accessed November 17, 2011.
    \8\ U.S. Department of Labor, Mine Safety and Health 
Administration. Mining Industry Accident, Injuries, Employment, and 
Production Data--Address & Employment Self-Extracting Files. http://www.msha.gov/stats/part50/p50y2k/aetable.htm. Accessed July 7, 
2011.
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    Finally, previously effective approaches to radiographic monitoring 
need to be modified to reflect the different characteristics of digital 
imaging compared to film-screen radiography. Additionally, due to the 
broad diversity of hardware and software utilized in digital imaging, 
specifications are required to assure that the operational 
characteristics of the image acquisition and display systems are 
sufficiently standardized to support uniformity among these health 
assessments. In addition, they must assure confidentiality to the 
extent permitted by law, data integrity, and interoperability.\9\ Most 
importantly, they must permit accurate identification of the early 
changes seen in dust-related diseases.
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    \9\ Samei E, Ravin CE [2008]. Assuring image quality for 
classification of digital chest radiographs. In: NIOSH. Application 
of the ILO International Classification of Radiographs of 
Pneumoconioses to Digital Chest Radiographic Images: A NIOSH 
Scientific Workshop. Cincinnati, OH: U.S. Department of Health and 
Human Services, Public Health Service, Centers for Disease Control 
and Prevention, National Institute for Occupational Safety and 
Health. DHHS (NIOSH) Publication No. 2008-139.
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B. Scope of Rulemaking

    Existing regulations under 42 CFR part 37 provide rules and 
specifications for giving, interpreting, classifying, and submitting 
chest radiographs as required under section 203 of the Federal Mine 
Safety and Health Act of 1977, as amended (30 U.S.C. 843). Those rules 
will essentially remain in effect: This rulemaking will not 
substantially alter the current standards, but will update the 
terminology used in the current standards (e.g., ``roentgenogram'' to 
``radiograph'') and include edits to maintain the accuracy of external 
references.
    Significantly, the new rule would expand the availability of chest 
radiographic examinations by establishing additional options for 
giving, interpreting, classifying, and submitting digitally-acquired 
radiographs under the same scope as the existing rule does for film 
radiographs. The proposed rule would establish the minimum 
specifications for methods, procedures, quality assurance, 
documentation, and equipment including computer software for facilities 
seeking approval to perform and submit digital radiographic 
examinations as well as the physician readers who interpret, classify, 
and submit reports using those radiographs. The proposed rule would 
also make limited changes to general requirements to reflect current 
terminology (such as the use of ``radiograph'' instead of 
``roentgenogram'' which is no longer commonly used), practice or needs, 
such as requiring mine operators to provide a roster of current miners 
to NIOSH, which uses this information to promote miner participation in 
the Coal Workers' Health Surveillance Program. The proposed rule will 
not modify existing requirements for miner radiographic examinations, 
eligibility, or other rights, including transfer of affected miners in 
accordance with 30 CFR part 90.

C. Impact of Rulemaking

    The U.S. Department of Labor (DOL) will likely amend its Black Lung 
Benefits Act (BLBA) program regulations to correspond with the changes 
proposed here. The BLBA provides disability compensation and medical 
benefits to miners disabled by pneumoconiosis and monthly compensation 
to their eligible survivors (30 U.S.C. 901-944). Because DOL is 
required to consult with NIOSH on the development of criteria for 
medical tests for coal miners (30 U.S.C. 902(f)(1)(D)), DOL has modeled 
its technical requirements for chest radiographs on those adopted by 
NIOSH for the Coal Workers' Health Surveillance Program (see 20 CFR 
718.102 and 20 CFR Part 718 Appendix A). DOL's Occupational Safety and 
Health Administration (OSHA) might also consider amending its current 
asbestos regulations for general industry, shipyard employment, and 
construction (29 CFR 1910.1001 Appendix E, 29 CFR 1915.1001 Appendix E, 
and 29 CFR 1926.1101 Appendix E, respectively). OSHA's asbestos 
regulations are related to this proposed rulemaking, although they are 
not explicitly linked by statute or regulation.
    The DOL standards refer to chest ``roentgenograms,'' an outdated 
term which NIOSH proposes to replace with the more contemporary 
``radiograph'' as discussed below in the summary of the proposed 
digital standards. The DOL standards also rely upon the same ILO 
standards for the classification of radiographs, and might need to be 
amended to comport with the 2011 version of the ILO Classification, as 
referenced in this proposed rule. Finally, the DOL standards refer to 
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.

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III. Summary of Proposed Rule

A. Subpart--Chest Radiographic Examinations

    This proposed rule would establish new requirements for digital 
radiography under existing part 37 of 42 CFR--Specifications for 
Medical Examinations of Underground Coal Miners. The new provisions 
would supplement and update the existing requirements for film-screen 
radiographs by establishing standards for digital radiographs. The 
following is a section-by-section summary which describes and explains 
the provisions of the rule. Table 1 matches the current regulatory 
provisions with the corresponding proposed provisions. The public is 
invited to provide comment on any aspect of the proposed rule. The 
proposed regulatory text for the proposed rule is provided in the last 
section of this notice.

                  Table 1--New and Proposed Provisions
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         Current regulation                  Proposed regulation
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37.2 Definitions                     37.2 Definitions
37.3 Chest roentgenograms required   37.3 Chest radiographs required for
 for miners                           miners
37.4 Plans for chest                 37.4 Plans for chest radiographic
 roentgenographic examinations        examinations
37.5 Approval of plans               37.5 Approval of plans
37.6 Chest roentgenographic          37.6 Chest radiographic
 examinations conducted by the        examinations conducted by the
 Secretary                            Secretary
37.7 Transfer of affected miner to   37.7 Transfer of affected miner to
 less dusty area                      less dusty area
37.8 Roentgenographic examination    37.8 Radiographic examination at
 at miner's expense                   miner's expense
37.20 Miner identification document  37.20 Miner identification document
37.40 General provisions             37.40 General provisions
37.41 Chest roentgenogram            37.41 Chest radiograph
 specifications                       specifications--film
37.42 Approval of roentgenographic   37.42 Chest radiograph
 facilities                           specifications--digital
                                      radiography systems
37.43 Protection against radiation   37.43 Approval of radiographic
 emitted by Roentgenographic          facilities that use film
 equipment
                                     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   37.50 Interpreting and classifying
 chest roentgenogram                  chest radiographs--film
37.51 Proficiency in the use of      37.51 Interpreting and classifying
 systems for classifying the          chest radiographs--digital
 pneumoconioses                       radiography systems
37.52 Method of obtaining            37.52 Proficiency in the use of
 definitive interpretations           systems for classifying the
                                      pneumoconioses
37.53 Notification of abnormal       37.53 Method of obtaining
 roentgenographic findings            definitive interpretations
                                     37.54 Notification of abnormal
                                      radiographic findings
37.60 Submitting required chest      37.60 Submitting required chest
 roentgenograms and miner             radiographs and miner
 identification documents             identification documents
37.70 Review of interpretations      37.70 Review of interpretations
37.80 Availability of records        37.80 ability of records
37.200 Scope                         37.200 Scope
37.201 Definitions                   37.201 Definitions
37.202 Payment for autopsy           37.202 Payment for autopsy
37.203 Autopsy specifications        37.203 Autopsy specifications
37.204 Procedure for obtaining       37.204 Procedure for obtaining
 payment                              payment
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Section 37.1 Scope
    This existing section provides the scope of these provisions, and 
remains unchanged from the current regulation.
Section 37.2 Definitions
    This existing section contains definitions for terms that appear 
throughout part 37. A number of terms appearing in the current 
regulations remain unchanged, including ``Act,'' ``convenient time and 
place,'' ``MSHA,'' ``miner,'' ``operator,'' and ``Secretary.''
    This section proposes to amend the following terms to reflect 
updated terminology and references: ``NIOSH,'' and ``chest 
radiograph.'' We propose to change ``pre-employment physical 
examination'' to ``pre-placement physical examination'' to be 
consistent with the requirements of the Americans with Disabilities Act 
of 1990 (42 U.S.C. 12112(d)) (ADA). The ADA prohibits an employer from 
asking or requiring a job applicant to take a medical examination or 
inquiring about whether an applicant has a disability before an offer 
of employment has been made. However, the ADA does allow an employer to 
require a medical examination after an offer of employment has been 
made, subject to certain restrictions. ``Panel of B Readers'' would be 
amended to indicate that the panel comprises all currently-approved B 
Readers.
    Finally, this section includes definitions of the following 
proposed new terms: ``digital radiography systems,'' ``computed 
radiography,'' ``digital radiography,'' ``NIOSH representatives,'' 
``qualified medical physicist,'' ``radiographic technique chart,'' 
``radiologic technologist,'' and ``soft copy.''
Section 37.3 Chest Radiographs Required for Miners
    This existing section requires mine operators to provide miners an 
opportunity to receive a chest radiograph. We propose a change to this 
provision to delete and replace outdated text. For example, in Sec.  
37.3(a), ``roentgenogram'' would be replaced by ``radiograph.'' 
Similarly in Sec.  37.3(a)(1), ``ALOSH'' would be replaced with 
``NIOSH.''
    Paragraph (b)(1) would be amended to remove reference to a pre-
employment physical examination, which is prohibited by the Americans 
with Disabilities Act of 1990 (42 U.S.C. 12112(d)). Paragraph (b)(3) 
would be amended to further clarify the classification of simple 
pneumoconioses.

[[Page 1364]]

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 X-ray facility 
or facilities.
    We propose to amend Sec.  37.4(a), (d), (e), and (f) to update 
terminology to reflect ``radiographic'' for ``roentgenographic'' and 
``NIOSH'' for ``ALOSH.''
    We propose to amend Sec.  37.4(a)(3) to specifically require the 
mine operator to submit a roster with the names and current addresses 
of covered miners with the operator's proposed plan. This is current 
practice and permits mailings directly from NIOSH to miners, which both 
emphasizes the extent of the confidentiality exercised by the program 
and explains the importance of the health surveillance program. As 
discussed above, such direct communication from NIOSH has proven 
important in encouraging miners' participation.
    We propose to amend Sec.  37.4(a)(6) to specify that when a coal 
mine operator examination plan lists a NIOSH-approved X-ray facility 
that uses a digital radiographic system, the listed physician who 
provides the first clinical reading of a coal miner's digital chest 
radiograph must have appropriate qualifications, but is not required to 
perform an ILO classification for pneumoconiosis. These initial 
clinical readings would therefore not be required to meet the 
specifications for pneumoconiosis classification listed in Sec.  37.51 
(b), (c), (d), and (e). This should increase the number of digital 
radiographic facilities available to miners that can be listed by coal 
mine operators on examination plans.
    We propose to amend Sec.  37.4(a)(7)(ii) to extend the existing 
confidentiality provisions for film radiographs to digital radiographs, 
including requiring, to the extent that is technically feasible for the 
imaging system used, the permanent deletion or rendering permanently 
inaccessible of all digital files at the facility. We further propose 
to amend this section to be consistent with the requirements of the 
Americans with Disabilities Act, which prohibits the use of pre-
employment medical examinations. We propose to strike the reference in 
this paragraph to the pre-employment examination and disclosure of 
information gained during that examination.
Section 37.5 Approval of Plans
    This existing section outlines the process undertaken by the 
Secretary of HHS to approve or deny approval of a Coal Mine Operator's 
Plan (Form CDC/NIOSH (M)2.10, OMB 0920-0020, exp. June 30, 2014). We 
propose to amend this section to redact outdated text and to correct 
gender-exclusive language.
Section 37.6 Chest Radiographic Examinations Conducted by the Secretary
    This existing section details the conditions under which the HHS 
Secretary will determine whether to conduct a chest radiographic 
examination. We propose to amend this section to replace outdated text 
with current terminology.
Section 37.7 Transfer of Affected Miner to Less Dusty Area
    Under 30 CFR part 90, miners whose radiographs show specific 
categories of pneumoconiosis are offered the right to frequent 
workplace dust monitoring, and transfer to a job environment with not 
more than 1 mg/m\3\ respirable dust levels, if needed and such a job is 
available at the mine. If such a work location is not available, 
transfer is offered to the job with the lowest exposure below 2 mg/
m\3\, which is the current permissible exposure limit for respirable 
dust enforced by MSHA in coal mines. We propose to amend this section 
to replace outdated text with current terminology. Also, we propose to 
replace ``2 mg/m\3\'' with ``the maximum respirable dust concentration 
permitted by MSHA'' and replace ``1 mg/m\3\'' with ``50 percent of the 
maximum respirable dust concentration permitted by MSHA.'' The revised 
wording would not impact current requirements; however it would remain 
consistent with any MSHA rulemaking that alters the relevant 
permissible exposure limits.
Section 37.8 Radiographic Examination at Miner's Expense
    This existing section provides for any miner who wishes to obtain a 
radiographic examination at his or her own expense. We propose to amend 
this section only to replace the outdated ``ALOSH'' with ``NIOSH.''
Section 37.20 Miner Identification Document
    This existing section requires the completion of a Miner 
Identification Document (Form CDC/NIOSH (M)2.9, OMB 0920-0020, exp. 
June 30, 2014) for each miner when the chest radiograph is made. We 
propose to amend this section only to replace ``roentgenographic'' and 
``roentgenogram'' with ``radiographic'' and ``radiograph.''
Section 37.40 General Provisions
    This existing section outlines general provisions for chest 
radiographic examinations. We propose to amend this section to update 
the terminology.
Section 37.41 Chest Radiograph Specifications--Film
    This existing section establishes performance standards for the 
acquisition of chest radiographs using film-screen technology. We 
propose to amend this section to update terminology and standards. We 
propose to add Sec.  37.41(c) to require that a radiologic technologist 
perform the radiograph. This requirement is new. The existing rule does 
not clearly specify the qualifications of the provider who performs the 
radiologic examination. In light of ongoing concerns related to 
radiation exposure, it is necessary to specify that this provider have 
documented qualifications.
    We propose to amend Sec.  37.41(i)(7) to remove the current 
language, ``[w]hen using over 90kV,'' because proposed Sec.  37.42(e), 
below, would require that radiographs be made by units having 
generators with a minimum rating of 300 mA at 125 kVp. We also propose 
to amend Sec.  37.41(m) to remove the word ``densitometric,'' as the 
test object may evaluate characteristics of the exposure in addition to 
density.
    We also propose to amend Sec.  37.41(h) to remove the reference to 
Part F of the Suggested State Regulations for the Control of Radiation, 
of the Conference of Radiation Control Program Directors (Rev 2009). 
The beam limiting device must be of the type described in 21 CFR 
1020.31(d), (e), (f), and (g).
    Finally, we propose to remove Sec.  37.41(i)(9), which requires 
that each facility shall establish a formal quality assurance program. 
This requirement would be instead inserted into proposed Sec.  37.43, 
which would set standards for the approval of radiographic facilities 
that use film (see below).
Section 37.42 Chest Radiograph Specifications--Digital Radiography 
Systems
    This proposed section establishes performance standards for the 
acquisition of chest radiographs using digital radiography systems, 
including digital radiography and computed radiography. We propose 
adding this

[[Page 1365]]

new section in its entirety; it is patterned after the existing Sec.  
37.41--Chest radiographic specifications for film.
    Proposed Sec.  37.42(a) would establish basic logistical 
requirements for conducting chest radiographic examination. For 
example, under this provision, the imaging facility would be required 
to provide a dressing area. This provision is identical to the existing 
regulation for film, Sec.  37.41(b).
    Proposed Sec.  37.42(b) would specify minimum requirements for the 
position of the subject of the radiograph and for the resolution and 
positioning of the resulting image. The required size and positioning 
of the X-ray detectors for digital systems is identical to that in the 
existing regulation for film-screen systems (Sec.  37.41(a)). Exact 
specifications for the digital imaging detector are provided because 
detectors must provide sufficient image size and gray scale depth to 
demonstrate the required subtle contrasts, and sufficient density of 
pixels to offer adequate resolution for the fine linear fibrotic 
shadows.\10\ The specification of a maximum pixel pitch of 200 [mu]m, a 
minimum gray-scale bit depth of 10, and spatial resolution of at least 
2.5 line pairs per millimeter are based upon the existing peer-reviewed 
research comparing digital and traditional imaging and ensures that the 
use of digital radiography systems will not result in reduced ability 
to recognize and quantify the abnormalities.\11\ Commercially-available 
imaging systems are able to meet these specifications.\12\
---------------------------------------------------------------------------

    \10\ Samei E [2008]. Acquisition of digital chest images for 
pneumoconiosis classification: Methods, procedures, and hardware. 
In: NIOSH. Application of the ILO International Classification of 
Radiographs of Pneumoconioses to Digital Chest Radiographic Images: 
A NIOSH Scientific Workshop. Cincinnati, OH: U.S. Department of 
Health and Human Services, Public Health Service, Centers for 
Disease Control and Prevention, National Institute for Occupational 
Safety and Health. DHHS (NIOSH) Publication No. 2008-139.
    \11\ Franzblau A, Kazerooni EA, Sen A, Goodsitt MM, Lee SY, 
Rosenman KD, Lockey JE, Meyer CA, Gillespie BW, Petsonk EL, Wang ML 
[2009]. Comparison of digital radiographs with film radiographs for 
the classification of pneumoconiosis. Acad Radiol 16(6):669-677.
     Sen A, Lee SY, Gillespie BW, Kazerooni EA, Goodsitt MM, 
Rosenman KD, Lockey JE, Meyer CA, Petsonk EL, Wang ML, Franzblau A 
[2010]. Comparison of reliability of classification for 
pneumoconiosis of film and digital radiographs: A modeling approach. 
Acad Radiol 17(4):511-519.
     Laney AS, Petsonk EL, Wolfe AL, Attfield MD [2009]. Comparison 
of storage phosphor computed radiography with conventional film-
screen radiography in the recognition of pneumoconiosis. Eur Respir 
J, published ahead of print November 19, 2009.
    \12\ Flynn MJ [2008]. Image presentation: Implications of 
processing and display. In: NIOSH. Application of the ILO 
International Classification of Radiographs of Pneumoconioses to 
Digital Chest Radiographic Images: A NIOSH Scientific Workshop. 
Cincinnati, OH: U.S. Department of Health and Human Services, Public 
Health Service, Centers for Disease Control and Prevention, National 
Institute for Occupational Safety and Health. DHHS (NIOSH) 
Publication No. 2008-139.
---------------------------------------------------------------------------

    Proposed Sec.  37.42(c) would require that chest radiographs 
obtained pursuant to these provisions must be made by a qualified 
radiologic technologist.
    Proposed Sec.  37.42(d) would specify the required size of the X-
ray machine's focal spot. This proposed provision would follow the 
existing regulation for film (Sec.  37.41(c)).
    Proposed Sec.  37.42(e) would specify the minimum amperage and 
voltage required to produce chest radiographs. This section would be 
identical to the existing regulation for film, Sec.  37.41(d), but with 
updated terminology.
    Proposed Sec.  37.42(f) would require radiographic equipment be 
used with a power supply that complies with the X-ray machine's 
manufacturer specifications. Adequately conditioned power is needed for 
consistent generation of the radiation exposure needed for imaging. The 
requirement to meet minimum power supply recommendations for the 
equipment assures that the imaging system can perform as intended and 
specified by the manufacturer.
    Proposed Sec.  37.42(g) would require that radiographic equipment 
has a beam-limiting device to reduce the amount of scatter and off-
focus radiation. While this provision largely mirrors the provision for 
film-screen systems (Sec.  37.41(g)), it also specifies that electronic 
means for limiting the size of the final image shall not be used. 
Electronic ``shutters'' are available for some digital radiography 
systems and can constrain image size but do not limit radiation 
exposure, and thus their use is prohibited to reduce the adverse health 
impact on the miner of unnecessary exposure to ionizing radiation 
associated with the radiograph.
    Proposed Sec.  37.42(h) would require the use of radiographic 
technique charts that are developed specifically for the X-ray system 
and detector combination used at a facility. If automated exposure 
control devices are used, they should be documented using 
professionally recommended methods; such information should be stored 
for 5 years after the miner's examination. NIOSH believes that 
retaining such records for 5 years is already standard business 
practice. Maintaining records is necessary to permit individuals at the 
facility to audit their own adherence to the guidance. Failure to 
maintain documentation is much easier to demonstrate and enforce than 
specific elevated radiation exposures for individual examinations. Five 
years was chosen as a compromise between minimizing records storage 
burden and maintaining the ability to perform meaningful audits both 
for NIOSH and for the facility staff.
    The proposed specifications for digital radiography systems follow 
existing regulations for film (Sec.  37.41(h)(3)) requiring specified 
exposure settings. Because of the recognized potential for higher 
ionizing radiation exposures using digital radiography systems, we have 
included additional requirements to limit these exposures in accordance 
with recommendations established by the American Association of 
Physicists in Medicine.\13\
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    \13\ Shepard SJ, Wang J, Flynn M, Gingold E, Goldman L, Krugh K, 
Leong DL, Mah E, Ogden K, Peck D, Samei E, Willis C [2009]. An 
exposure indicator for digital radiography. Report of AAPM Task 
Group 116. College Park, MD: American Association of Physicists in 
Medicine. AAPM Report No. 116.
    Rossi R, Lin PJ, Rauch P, Strauss K [1985]. Performance 
specifications and acceptance testing for X-ray generators and 
automatic exposure control devices. Report of the Diagnostic X-Ray 
Imaging Committee Task Group on Performance Specifications and 
Acceptance Testing for X-Ray Generators and Automatic Exposure 
Control Devices. AAPM Report No. 14.
    Seibert JA, Bogucki TM, Ciona T, Huda W, Karellas A, Mercier J, 
Samei E, Shepart SJ, Steward B, Strauss K, Suleiman O, Tucker D, 
Uzenoff R, Weiser JC, Willis C [2006]. Acceptance testing and 
quality control of photostimulable storage phosphor imaging systems. 
Report of AAPM Task Group 10. College Park, MD: American Association 
of Physicists in Medicine. AAPM Report No. 93.
---------------------------------------------------------------------------

    Proposed Sec.  37.42(i)(1) would require that the maximum exposure 
time not exceed 50 milliseconds except for subjects of a certain size. 
This provision would mirror the existing regulation for film-screen 
technology (Sec.  37.41(h)(1), although the text is modified to use 
contemporary timing units.
    Proposed Sec.  37.42(i)(2) would specify the required distance from 
the source or focal spot to the detector. This provision mirrors the 
existing regulation for film (Sec.  37.41(g)) but with additional text 
clarifying metric units.
    Proposed Sec.  37.42(i)(3) would specify the required exposure 
setting for digital radiographs and incorporate by reference current 
professional standards intended to limit exposures from digital 
radiographs. This proposed section mirrors existing regulations for 
film-screen technology (Sec.  37.41(h)(3)).
    Proposed Sec.  37.42(i)(4) would establish that digital radiography 
system performance, including image signal-to-noise and detective 
quantum efficiency, be evaluated and meet the standards of

[[Page 1366]]

a qualified medical physicist in accordance with current professional 
standards, which are incorporated by reference in this section. This 
section would also govern the use of image management software. Digital 
systems use direct or indirect quantification of electronic signals 
from the detectors, and thus the character and quality of the resulting 
image is affected by both hardware and software signal management. To 
ensure that images collected for the purposes of this regulation using 
digital systems are adequate, it is important that approved imaging 
systems satisfy the relevant contemporary professionally recommended 
minimum performance criteria. Further, to improve comparability in the 
character of chest radiographic images submitted by different approved 
facilities for the purposes of this regulation, this section would 
require that image management software and settings for routine chest 
imaging be used.
    In addition to management software, manufacturers of digital 
radiography systems provide unique proprietary versions of image 
modifying software, and the resulting images have distinctly different 
appearances. There is currently no scientific consensus that a specific 
approach to image enhancement software provides superior performance in 
imaging pneumoconiotic opacities. Therefore, this section would 
prohibit the use of image enhancement, except to the extent that some 
enhancement features might be integral to the digital radiography 
system and hence are not elective; for such cases, this section would 
specify that image enhancement be minimized to the extent permitted by 
the system.
    Proposed Sec.  37.42(i)(5) would establish the Digital Imaging and 
Communications in Medicine (DICOM) standard \14\ as the relevant data 
storage and transmission standard. At a 2008 NIOSH workshop, entitled 
Application of the ILO International Classification of Radiographs of 
Pneumoconioses to Digital Chest Radiographic Images, participants 
evaluated digital chest radiographic image file formats, and found that 
aside from DICOM, there are currently no other adequately specified 
digital image formats that support the resolution, security, and 
interoperability required for this application.\15\ Chest radiographic 
images obtained using digital systems are stored and transferred as 
electronic data files. To ensure the integrity of the information, 
patient/worker confidentiality, full access by appropriate parties to 
the complete data file, compatibility with hardware systems from 
various manufacturers, and uniformity of image viewing and data 
management, the proposed rule would require that images collected for 
the purposes of this regulation using digital systems be formatted 
using the industry standardized electronic format, and that any data 
compression employed be lossless. Physical, technical, and 
administrative controls are specified to prevent unauthorized access to 
protected health information and confidential medical findings, during 
data acquisition, storage, and transfer. To support the uniform 
grayscale standard display function of image display devices, images 
must be formatted as DICOM ``DX'' objects.\16\ To enable auditing of 
radiation exposure data over time, the facility would be required to 
maintain either written or electronic records, formatted according to 
industry standards when possible.
---------------------------------------------------------------------------

    \14\ DICOM is a widely-accepted standard for handling, storing, 
printing, and transmitting medical imaging information. DICOM is 
managed by the National Electrical Manufacturers Association.
    \15\ NIOSH [2008]. Application of the ILO International 
Classification of Radiographs of Pneumoconioses to Digital Chest 
Radiographic Images: A NIOSH Scientific Workshop. Cincinnati, OH: 
U.S. Department of Health and Human Services, Public Health Service, 
Centers for Disease Control and Prevention, National Institute for 
Occupational Safety and Health. DHHS (NIOSH) Publication No. 2008-
139.
    \16\ Clunie DA. Standardizing file formats, security, and 
integration of digital chest image files for pneumoconiosis 
classification. In: NIOSH. Application of the ILO International 
Classification of Radiographs of Pneumoconioses to Digital Chest 
Radiographic Images: A NIOSH Scientific Workshop. Cincinnati, OH: 
U.S. Department of Health and Human Services, Public Health Service, 
Centers for Disease Control and Prevention, National Institute for 
Occupational Safety and Health. DHHS (NIOSH) Publication No. 2008-
139.
---------------------------------------------------------------------------

    Proposed Sec.  37.42(i)(6) would allow NIOSH the discretion to 
require the use of a test object for an evaluation of image quality. 
This section is identical to existing film regulation Sec.  37.41(l), 
although the term `densitometric' has been omitted in describing the 
test object, as the object may evaluate characteristics of the exposure 
in addition to density.
    Proposed Sec.  37.42(i)(7) would require computed radiography (X-
ray image acquisition systems that detect signals using a cassette-
based photostimulable storage phosphor) imaging plates to be inspected 
regularly and cleaned when necessary. This specification preserves the 
existing required periodicity of cleaning because, for storage phosphor 
digital systems as with film-screen systems, periodic cleaning of 
equipment is necessary to reduce the possibility of image artifacts.
    Proposed Sec.  37.42(i)(8) would require the use of a grid or air 
gap for reducing radiation scatter. This section mirrors the existing 
regulation for film (Sec.  37.41(h)(7)) with additional language 
addressing interference patterns. Such patterns can arise using digital 
techniques, and can interfere with image classification and the 
detection of abnormalities.
    Proposed Sec.  37.42(i)(9) would establish the geometry of the 
radiographic system. This section mirrors existing film regulation 
Sec.  37.41(h)(8), with text amended to reflect the digital technology 
rather than film.
    Proposed Sec.  37.42(i)(10) would require that radiographic 
equipment meet recommended environmental temperature and humidity 
thresholds set by the manufacturer. This requirement would be exclusive 
to digital radiography systems, and would ensure that the imaging 
system can perform as intended and as specified by the manufacturer.
    Proposed Sec.  37.42(i)(11) would ensure that the miner receives a 
chest radiograph determined to be of acceptable quality before being 
advised that the examination is concluded. In the event of a 
substandard radiograph, under this section, a miner would immediately 
be given another. Finally, this section would also require that 
unacceptable digital image files immediately be permanently deleted or 
rendered inaccessible in the event that permanent deletion is not 
technologically feasible. These requirements are identical to that for 
film (Sec.  37.41(j)) except that the text refers to the deletion of 
digital files rather than the disposal of films.
    Proposed Sec.  37.42(j)(1) and (2) would prohibit the use of 
digital images derived from film-screen chest radiographs for the 
purposes of this rule. Similarly, images acquired using digital systems 
and then printed on transparencies would also be prohibited. Research 
has shown that these approaches do not assure similar performance to 
that obtained from film under the existing regulations (Sec.  
37.41).\17\
---------------------------------------------------------------------------

    \17\ Samei E [2008]. Acquisition of digital chest images for 
pneumoconiosis classification: Methods, procedures, and hardware. 
In: NIOSH. Application of the ILO International Classification of 
Radiographs of Pneumoconioses to Digital Chest Radiographic Images: 
A NIOSH Scientific Workshop. Cincinnati, OH: U.S. Department of 
Health and Human Services, Public Health Service, Centers for 
Disease Control and Prevention, National Institute for Occupational 
Safety and Health. DHHS (NIOSH) Publication No. 2008-139.
    Franzblau A, Kazerooni EA, Sen A, Goodsitt MM, Lee SY, Rosenman 
KD, Lockey JE, Meyer CA, Gillespie BW, Petsonk EL, Wang ML [2009]. 
Comparison of digital radiographs with film radiographs for the 
classification of pneumoconiosis. Acad Radiol 16(6):669-677.
     Suganuma N, Murata K, Kusaka Y [2008]. CR and FPD DR chest 
radiographic image parameters for the pneumoconioses: The Japanese 
approach and experience. In: NIOSH. Application of the ILO 
International Classification of Radiographs of Pneumoconioses to 
digital chest radiographic images: A NIOSH Scientific Workshop. 
Cincinnati, OH: U.S. Department of Health and Human Services, Public 
Health Service, Centers for Disease Control and Prevention, National 
Institute for Occupational Safety and Health. DHHS (NIOSH) 
Publication No. 2008-139.
    Franzblau A, Kazerooni EA, Goodsitt M [2009]. Digital X-ray 
imaging in pneumoconiosis screening: Future challenges for the NIOSH 
B Reader Program. In: NIOSH. The NIOSH B Reader Certification 
Program: Looking to the future. Cincinnati, OH: U.S. Department of 
Health and Human Services, Public Health Service, Centers for 
Disease Control and Prevention, National Institute for Occupational 
Safety and Health. DHHS (NIOSH) Publication No. 2009-140.

---------------------------------------------------------------------------

[[Page 1367]]

Section 37.43 Approval of Radiographic Facilities That Use Film
    Proposed Sec.  37.43 would comprise the current requirements in 
existing Sec.  37.42--Approval of roentgenographic facilities. Proposed 
Sec.  37.43(a) would base facility eligibility to participate in the 
Coal Workers' Health Surveillance Program on a demonstrated ability to 
make high quality diagnostic chest radiographs. This section remains 
unchanged from the existing provision but for the addition of text 
indicating that an object other than the plastic step wedge objects may 
be used. Newer test objects have become available, and in the future, 
NIOSH may want to use a more compact and capable test object that is 
simpler to use than the step wedges.
    Proposed Sec.  37.43(b) would specify requirements for an X-ray 
Facility Certification Document (Form CDC/NIOSH (M)2.11, OMB 0920-0020, 
exp. June 30, 2014) describing each X-ray unit to be used to make chest 
radiographs. This section would be unchanged from the existing Sec.  
37.42(c) except for the replacement of outdated terminology, including 
incorporation by reference of National Council on Radiation Protection 
and Measurements (NCRP) Report No. 102.
    Proposed Sec.  37.43(c) would establish that radiographs submitted 
with a facility application be evaluated by a qualified consultant or 
one or more individuals selected by NIOSH from the panel of B Readers. 
This section would be substantively unchanged from the existing Sec.  
37.42(d), although we propose to amend this section to replace outdated 
text with current terminology, specifically by substituting the term 
'medical physicist' for 'radiological physicist.'
    Proposed Sec.  37.43(d) would describe NIOSH's authority to conduct 
a physical inspection of the applicant's facility to determine if the 
requirements of this subpart are being met. We propose to amend this 
section from the existing Sec.  37.42(e) by updating outdated 
terminology.
    Proposed Sec.  37.43(e) would allow NIOSH the discretion to require 
a facility to resubmit radiographs of a test object, sample 
radiographs, or a Facility Certification Document for quality control 
purposes. It would also establish the conditions under which NIOSH may 
suspend or withdraw a facility's approval and how notice must be given. 
We propose to amend this section from the existing Sec.  37.43(f) by 
updating outdated terminology.
    Proposed Sec.  37.43(f) would require that facilities establish a 
formal quality assurance program conforming to standards published by 
the American Association of Physicists in Medicine and incorporated by 
reference here. This provision would replace existing Sec.  
37.41(h)(9), which requires that facilities establish a formal quality 
assurance program, with more specific quality assurance program 
guidelines. We propose that the program must be written, address 
radiation exposures, equipment maintenance, and image quality, and 
conform to the referenced professional standards. Several years ago, 
NIOSH initiated an image quality feedback program to try to improve the 
film quality; NIOSH therefore wishes to ensure that the facilities have 
documented quality assurance programs. This provision will also permit 
NIOSH to easily request copies of the documentation, and thus more 
easily determine if a facility has adequately addressed their image 
quality issues.
    Proposed Sec.  37.43(g) would add the explicit requirement that 
facilities adhere to Federal, State, and local laws, as applicable, to 
protect the confidentiality and privacy of coal miners participating in 
the Program. Through this provision, NIOSH seeks to ensure that X-ray 
facilities maintain miners' sensitive health information securely and 
protect it from disclosure to the extent permitted by law.
Section 37.44 Approval of Radiographic Facilities That Use Digital 
Radiography Systems
    Proposed Sec.  37.44 would establish standards for the approval of 
radiographic facilities that use digital radiography systems. These 
standards mirror those for film-screen technology.
    Proposed Sec.  37.44(a)(1) would specify the requirements for a 
facility approval application, including an image of a test object, and 
six or more sample radiographs of quality acceptable to one or more 
individuals selected by NIOSH from the panel of B Readers and a 
qualified medical physicist. The existing requirements for facilities 
to demonstrate radiograph quality are continued (Sec.  37.42(b)) but to 
reduce the burden on facilities, radiographs made up to 60 days prior 
to the application may be submitted. The time extension (from the 
existing 15 days for film-based systems) eases the burden on applicants 
by giving them a longer window of time to select a representative 
image, while continuing to ensure that the images that are submitted 
reflect the facility's contemporary image quality; changes in digital 
image quality are unlikely to occur in the time frame indicated (i.e., 
60 days). In the past, wet systems such as film processors and 
chemicals could get diluted or dirty in shorter times when many films 
were processed, however, because there are no liquids and very few 
moving parts in digital systems, the time frame for quality 
deterioration is longer, and thus a longer time is more convenient but 
still should be representative of the digital image quality. This 
provision would also require the image files to be submitted using a 
secure electronic file transfer method approved by NIOSH, or on 
standard portable media and meet the current DICOM specifications for 
diagnostic media interchange.
    Proposed Sec.  37.44(a)(2) would specify the contents of the X-ray 
Facility Certification Document. This paragraph would continue the 
existing requirement for documentation and inspection of eligible 
facilities by a qualified expert within 1 year preceding the date of 
the application (Sec.  37.42(c)), and would clarify that the expert 
must be a medical physicist. NIOSH has always expected that a medical 
physicist perform these evaluations, and now intends to codify that 
expectation.
    Proposed Sec.  37.44(b) would require that facilities maintain 
relevant local, State, or Federal licensure and certification. The 
existing requirement that radiographic facilities conform to applicable 
State and Federal regulations (Sec.  37.43) is continued.
    Proposed Sec.  37.44(c) would allow NIOSH the discretion to conduct 
a site inspection of the facility. Existing regulations for film (Sec.  
37.42(e)) specify periodic inspections, and this requirement is 
continued for digital systems.
    Proposed Sec.  37.44(d) would allow NIOSH the discretion to require 
a facility to resubmit image files of the test object, sample 
radiographs, or

[[Page 1368]]

Facility Certification Document. The provision would also authorize 
NIOSH to suspend or withdraw a facility's approval when warranted due 
to noncompliance with provisions of this rule.
    Proposed Sec.  37.44(e) would require that facilities have a 
qualified medical physicist on site or available as a consultant. To 
minimize risks and assure standardized and predictable image quality 
from sophisticated digital radiography systems, facilities must have 
available highly trained individuals who are skilled in evaluating the 
equipment, methods, and procedures.\18\
---------------------------------------------------------------------------

    \18\ Samei E [2008]. Acquisition of Digital Chest Images for 
Pneumoconiosis Classification: Methods, Procedures, and Hardware. 
In: NIOSH. Application of the ILO International Classification of 
Radiographs of Pneumoconioses to Digital Chest Radiographic Images: 
A NIOSH Scientific Workshop. Cincinnati, OH: U.S. Department of 
Health and Human Services, Public Health Service, Centers for 
Disease Control and Prevention, National Institute for Occupational 
Safety and Health. DHHS (NIOSH) Publication No. 2008-139.
---------------------------------------------------------------------------

    Proposed Sec.  37.44(f) would require that facilities document the 
findings by the medical physicist that each image acquisition system 
has met initial specifications and standards of the equipment 
manufacturer and performance testing. Since the 1980s, major advances 
have occurred in the practice of clinical radiology, most notably in 
the widespread adoption of digital technologies and systems for image 
acquisition, storage, transfer, and display.\19\ These digital 
technologies offer unique benefits for the identification and 
classification of pneumoconiosis, but due to the added complexities of 
digital radiography systems compared with film-screen radiology, these 
benefits may only be realized with proper implementation and 
utilization of the digital systems.\20\ To assure that the systems 
perform at the level required to meet the purposes of this Part, 
performance must be assessed by qualified individuals.
---------------------------------------------------------------------------

    \19\ NIOSH [2008]. Application of the ILO International 
Classification of Radiographs of Pneumoconioses to Digital Chest 
Radiographic Images: A NIOSH Scientific Workshop. Cincinnati, OH: 
U.S. Department of Health and Human Services, Public Health Service, 
Centers for Disease Control and Prevention, National Institute for 
Occupational Safety and Health. DHHS (NIOSH) Publication No. 2008-
139.
    \20\ Samei E, Ravin CE [2008]. Assuring image quality for 
classification of digital chest radiographs. In: NIOSH. Application 
of the ILO International Classification of Radiographs of 
Pneumoconioses to Digital Chest Radiographic Images: A NIOSH 
Scientific Workshop. Cincinnati, OH: U.S. Department of Health and 
Human Services, Public Health Service, Centers for Disease Control 
and Prevention, National Institute for Occupational Safety and 
Health. DHHS (NIOSH) Publication No. 2008-139.
---------------------------------------------------------------------------

    Proposed Sec.  37.44(g) would require facilities to implement a 
quality assurance program, and would incorporate by reference the 
standards set by the American Association of Physicists in Medicine. 
This provision continues the existing requirement for a quality control 
program, (Sec.  37.41(h)(9)) and further specifies professionally 
recommended procedures that must be an integral part of the operation 
of each digital radiography system. To ensure that radiologic 
examinations required under this Part are safe, reliable, and accurate, 
facilities that are approved to provide examinations using digital 
equipment must demonstrate that personnel, equipment, and procedures 
adhere to professionally accepted guidelines.\21\
---------------------------------------------------------------------------

    \21\ Franzblau A, Kazerooni EA, Goodsitt M [2009]. Digital X-ray 
imaging in pneumoconiosis screening: Future challenges for the NIOSH 
B Reader Program. In: NIOSH. The NIOSH B Reader Certification 
Program: Looking to the future. Cincinnati, OH: U.S. Department of 
Health and Human Services, Public Health Service, Centers for 
Disease Control and Prevention, National Institute for Occupational 
Safety and Health. DHHS (NIOSH) Publication No. 2009-140.
     NIOSH [2008]. Application of the ILO International 
Classification of Radiographs of Pneumoconioses to Digital Chest 
Radiographic Images: A NIOSH Scientific Workshop. Cincinnati, OH: 
U.S. Department of Health and Human Services, Public Health Service, 
Centers for Disease Control and Prevention, National Institute for 
Occupational Safety and Health. DHHS (NIOSH) Publication No. 2008-
139.
---------------------------------------------------------------------------

    Proposed Sec.  37.44(g)(1) would require that facility approval 
applications include a comprehensive assessment by a qualified medical 
physicist within 12 months prior to application. This paragraph would 
incorporate by reference guidelines established by the American 
Association of Physicists in Medicine. This provision continues the 
existing requirement (Sec.  37.42(c)).
    Proposed Sec.  37.44(g)(2) would require the use of radiographic 
technique charts developed for the specific X-ray system and detector 
combination used at the facility. This section would incorporate by 
reference monitoring methods specified by the American Association of 
Physicists in Medicine, and radiation exposure reference levels 
specified by the American College of Radiology. Unlike film-screen 
radiology, digital radiography systems are susceptible to dose 
creep.\22\ Dose creep in this setting involves increasing examinee 
radiation exposures over time for similar types of examinations (e.g., 
chest radiographs) performed at a facility. The tendency to increase 
radiation exposures over time, beyond the levels necessary, results 
from the characteristics of digital image detectors (which provide 
excellent image quality when images are overexposed, but suboptimal 
image quality when underexposed) combined with the desire on the part 
of facilities to avoid repeat examinations. For this reason, as 
recommended by professional bodies, facilities utilizing digital 
systems for examinations under this Part are required to take 
additional steps to ensure optimal exposures, and to maintain records 
of annual monitoring and evaluation of representative radiation 
exposures over time, using standardized methods, metrics, and 
documentation.\23\
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    \22\ Schaefer-Prokop C, Neitzel U, Venema HW, Uffmann M, Prokop 
M [2008]. Digital chest radiography: An update on modern technology, 
dose containment and control of image quality. Eur Radiol 
18(9):1818-1830.
    \23\ Shepard SJ, Wang J, Flynn M, Gingold E, Goldman L, Krugh K, 
Leong DL, Mah E, Ogden K, Peck D, Samei E, Willis C [2009]. An 
exposure indicator for digital radiography. Report of AAPM Task 
Group 116. College Park, MD: American Association of Physicists in 
Medicine. AAPM Report No. 116.
    ACR Practice Guideline for diagnostic reference levels in 
medical X-ray imaging. Revised 2008 (Res. 3).
    ACR Technical Standard for diagnostic medical physics 
performance monitoring of radiographic and fluoroscopic equipment. 
Revised 2006 (Res. 29,16g,17).
---------------------------------------------------------------------------

    Proposed Sec.  37.44(g)(3) would require that the performance of a 
digital radiography device be monitored according the recommendations 
of the medical physicist. Facilities would be required to maintain 
documentation upon the completion of quality assurance testing, and 
make it available to NIOSH for 5 years. NIOSH believes that retaining 
such records for 5 years is already standard business practice. This 
provision would also specify that certain tests are not required as a 
part of the quality assurance program for digital radiography systems 
(digital image acquisition systems in which the X-ray signals received 
by the image detector are converted to electronic signals without 
movable cassettes). This section provides more detailed guidance 
specific to the contemporary types of digital systems.
    Proposed Sec.  37.44(g)(4) would require that facilities maintain 
documentation on the implementation and monitoring of policies and 
procedures required under this section. Documentation of key metrics is 
essential for facility management to assure adherence to internal 
policies, and provides a mechanism for NIOSH inspections to determine 
if the purposes of this Part are being met.
    Proposed Sec.  37.44(h) would add the explicit requirement that 
facilities adhere to Federal laws to protect the confidentiality and 
privacy of coal miners participating in the program.

[[Page 1369]]

NIOSH seeks to ensure that miners' sensitive health information remains 
secure and is protected to the extent permitted by law.
Section 37.45 Protection Against Radiation Emitted by Radiographic 
Equipment
    This proposed provision would require that radiographic equipment 
conform to applicable State, territorial, and Federal regulations. 
Where no State, territorial or Federal regulations apply, the section 
would incorporate by reference the recommendations of the NCRP. This 
provision is unchanged from the existing Sec.  37.45, although 
references for the NCRP recommendations and contact information would 
be updated.
Section 37.50 Interpreting and Classifying Chest Radiographs--Film
    Proposed procedures for classifying radiographs would be unchanged 
from the existing Sec.  37.50, but for updating the requirement that 
images be interpreted and classified in accordance with the ILO 
International Classification of Radiographs for Pneumoconioses, 2011 
edition.\24\ The revised 2011 edition of the Guidelines for the use of 
the ILO International Classification of Radiographs of Pneumoconioses 
extends the applicability of the prior edition of the Classification to 
digital radiographic images of the chest. The proposed section would 
retain the existing provision that radiographs must be interpreted by 
an A or B Reader who has access to a complete set of the ILO 
Classification standard images, but would clarify that initial 
interpretations and notification of any findings other than that of 
pneumoconiosis shall be performed by a qualified physician. Provisions 
referring to view boxes would also be retained. Further, this section 
would be newly designated to apply only to film-screen radiographs.
---------------------------------------------------------------------------

    \24\ International Labour Office [2011]. Guidelines for the use 
of ILO International Classification of Pneumoconiosis, revised 
edition 2011). Geneva, Switzerland: International Labour Office. 
Occupational Safety and Health Series No. 22 (Rev. 2011).
---------------------------------------------------------------------------

Section 37.51 Interpreting and Classifying Chest Radiographs--Digital 
Radiography Systems
    Proposed Sec.  37.51(a) and (b) are similar to the first two 
provisions of Sec.  37.50 for film radiographs, discussed above. 
Clinical readings of digital chest radiographs obtained under this Part 
must be performed by physicians who are qualified and licensed and who 
read chest radiographs in the normal course of practice. However, in 
NIOSH's judgment, it would not be feasible to require that all 
physicians who provide the initial readings demonstrate proficiency 
with the ILO Classification of digital radiographs as specified in this 
Section. Such physicians are not sufficiently available to conduct 
these initial readings for coal miners in all locations in the United 
States. Thus the proposed rule specifies that a qualified and licensed 
physician who reads chest radiographs in the normal course of practice 
is qualified to provide interpretation and notification of any abnormal 
findings other than pneumoconiosis.
    The ILO has recently authorized the use of the ILO Classification 
for digital images and authorized a set of standard digital image files 
for use during classification. Paragraph Sec.  37.51(b) would specify 
that the classification of digital images be done ``in a manner 
consistent with the ILO International Classification of Radiographs of 
Pneumoconioses 2011.''
    Proposed Sec.  37.51(c) would require radiograph interpreters to 
have available to them a complete set of NIOSH-approved standard 
digital chest radiographic images. The ILO classification system has 
provided a standardized approach to recognizing, describing, and 
quantifying abnormalities on the chest radiograph caused by dust.\25\ A 
set of standard film images is provided by the ILO and required to be 
used in side-by-side comparisons when classifying radiographs. These 
ILO standard images were originally obtained using film-screen 
radiography, without application of edge enhancement or noise reduction 
software. Research using film-screen radiographs and classifications 
based upon the current ILO standard film radiographs has demonstrated 
that chest radiograph classification results correlate significantly 
with objective independent measures of dust exposure or lung dust 
content.\26\ To maintain the documented validity of the ILO 
classification system, the rule specifies that each reader compare 
digital images submitted under this regulation with NIOSH-approved 
digital versions of the standard images, and that no software 
modification of the standard images can be permitted.
---------------------------------------------------------------------------

    \25\ Id.
    \26\ Ruckley VA, Fernie JM, Chapman JS, Collings P, Davis JM, 
Douglas AN, Lamb D, and Seaton A [1984]. Comparison of radiographic 
appearances with associated pathology and lung dust content in a 
group of coalworkers. Br J Ind Med 41(4): 459-467.
    Cockcroft A, Lyons JP, Andersson N, and Saunders MJ [1983]. 
Prevalence and relation to underground exposure of radiological 
irregular opacities in South Wales coal workers with pneumoconiosis. 
Br J Ind Med 40(2): 169-172.
---------------------------------------------------------------------------

    Proposed Sec.  37.51(d) would require that viewing systems enable 
readers to display the chest image at full resolution, side-by-side 
with the selected NIOSH-approved standard image for comparison. This 
section would establish specifications for image display devices, 
including megapixels (MP) and bit depth; displays and associated 
graphics cards should meet the specifications of the current DICOM 
standard. This section would also set standards for display system 
luminance, relative noise, linearity, modulation transfer function 
(MTF), frequency, and glare by incorporating AAPM recommendations by 
reference. Finally, this section would require that displays be 
situated to minimize front surface glare.
    Visualization of the shadows on the chest radiograph caused by 
dust-related fibrosis is one of the most difficult challenges in 
medical diagnostic imaging. The viewing systems must provide sufficient 
luminance and gray scale depth to demonstrate the required subtle 
contrasts, and sufficient display size and density of pixels to reflect 
the resolution of the image file provided by the image detectors and 
required to visualize the fine linear fibrotic shadows.\27\ Research 
studies have demonstrated that reader recognition of pneumoconiosis on 
digital radiology systems can be equivalent to that achieved using 
film-screen radiology systems when appropriate system specifications 
and devices are employed.\28\ Additionally, adherence to the grayscale 
standard display function is required to assure that the appearance

[[Page 1370]]

of the images is independent of the specific digital device used for 
display.
---------------------------------------------------------------------------

    \27\ Flynn MJ [2008]. Image presentation: Implications of 
processing and display. In: NIOSH. Application of the ILO 
International Classification of Radiographs of Pneumoconioses to 
Digital Chest Radiographic Images: A NIOSH Scientific Workshop. 
Cincinnati, OH: U.S. Department of Health and Human Services, Public 
Health Service, Centers for Disease Control and Prevention, National 
Institute for Occupational Safety and Health. DHHS (NIOSH) 
Publication No. 2008-139.
    \28\ Franzblau A, Kazerooni EA, Sen A, Goodsitt MM, Lee SY, 
Rosenman KD, Lockey JE, Meyer CA, Gillespie BW, Petsonk EL, Wang ML 
[2009]. Comparison of digital radiographs with film radiographs for 
the classification of pneumoconiosis. Acad Radiol 16(6):669-677.
     Sen A, Lee SY, Gillespie BW, Kazerooni EA, Goodsitt MM, 
Rosenman KD, Lockey JE, Meyer CA, Petsonk EL, Wang ML, Franzblau A 
[2010]. Comparison of reliability of classification for 
pneumoconiosis of film and digital radiographs: A modeling approach. 
Acad Radiol 17(4):511-519.
     Laney AS, Petsonk EL, Wolfe AL, Attfield MD [2009]. Comparison 
of storage phosphor computed radiography with conventional film-
screen radiography in the recognition of pneumoconiosis. Eur Respir 
J, published ahead of print November 19, 2009.
---------------------------------------------------------------------------

    Proposed Sec.  37.51(d)(4) would also require that the measurements 
of pleural shadows and parenchymal opacities shall be taken using 
calibrated software measuring tools. This section would also require 
that, if possible, a record be made of the presentation state. Each 
individual reader is generally offered the option to select a specific 
setting that he or she judges to optimize the display characteristics 
of the chest radiographic image during the classification process; 
however, recording of the presentation states and annotations would be 
required (with compatible software) and would permit subsequent 
evaluation, using a Grayscale Standard Display Function (GSDF) 
compliant monitor, of the specific image that was displayed and 
interpreted by the reader who performed the classification.\29\
---------------------------------------------------------------------------

    \29\ Samei E, Ravin CE [2008]. Assuring image quality for 
classification of digital chest radiographs. In: NIOSH. Application 
of the ILO International Classification of Radiographs of 
Pneumoconioses to Digital Chest Radiographic Images: A NIOSH 
Scientific Workshop. Cincinnati, OH: U.S. Department of Health and 
Human Services, Public Health Service, Centers for Disease Control 
and Prevention, National Institute for Occupational Safety and 
Health. DHHS (NIOSH) Publication No. 2008-139.
---------------------------------------------------------------------------

    Proposed Sec.  37.51(e) would require that quality control 
procedures for devices used to display images for classification comply 
with the recommendations of the American Association of Physicists in 
Medicine, which are incorporated by reference. Further, this section 
would require that if automatic quality assurance systems are used, 
regular visual inspection also be performed using test patterns 
recommended by the medical physicist. Periodic maintenance and 
assessment of the display devices is essential to document that 
performance continues to meet current professional recommendations.\30\ 
Because various automated systems may not detect all defects in digital 
display devices (such as distortion, dropout of pixels, or surface 
reflections), periodic visual inspections are also important to assure 
the display performance is adequate.
---------------------------------------------------------------------------

    \30\ Id.
---------------------------------------------------------------------------

    Proposed Sec.  37.51(f) would establish that the classification of 
digitally-acquired radiographs be based on the viewing of images 
displayed as soft copies, and not as hard copy printed transparencies. 
Further, proposed Sec.  37.51(g) would prohibit the use of digitized 
copies of film-screen acquired images. There is currently no sufficient 
scientific consensus regarding the equivalence of classifications 
performed using either 1) hard copies of digitally-acquired images or 
2) digitized versions of film-screen radiographs in comparison to 
classifications performed using traditional film screen radiographic 
methods. For this reason, classifications based upon these two 
alternative approaches will not be accepted at this time.\31\
---------------------------------------------------------------------------

    \31\ Samei E. Acquisition of digital chest images for 
pneumoconiosis classification: Methods, procedures, and hardware. 
In: NIOSH. Application of the ILO International Classification of 
Radiographs of Pneumoconioses to Digital Chest Radiographic Images: 
A NIOSH Scientific Workshop. Cincinnati, OH: U.S. Department of 
Health and Human Services, Public Health Service, Centers for 
Disease Control and Prevention, National Institute for Occupational 
Safety and Health. DHHS (NIOSH) Publication No. 2008-139.
    Franzblau A, Kazerooni EA, Sen A, Goodsitt MM, Lee SY, Rosenman 
KD, Lockey JE, Meyer CA, Gillespie BW, Petsonk EL, Wang ML [2009]. 
Comparison of digital radiographs with film radiographs for the 
classification of pneumoconiosis. Acad Radiol 16(6):669-677.
    Suganuma N, Murata K, Kusaka Y [2008]. CR and FPD DR chest 
radiographic image parameters for the pneumoconioses: The Japanese 
approach and experience. In: NIOSH. Application of the ILO 
International Classification of Radiographs of Pneumoconioses to 
digital chest radiographic images: A NIOSH Scientific Workshop. 
Cincinnati, OH: U.S. Department of Health and Human Services, Public 
Health Service, Centers for Disease Control and Prevention, National 
Institute for Occupational Safety and Health. DHHS (NIOSH) 
Publication No. 2008-139.
    Franzblau A, Kazerooni EA, Goodsitt M [2009]. Digital X-ray 
imaging in pneumoconiosis screening: Future challenges for the NIOSH 
B Reader Program. In: NIOSH. The NIOSH B Reader Certification 
Program: Looking to the future. Cincinnati, OH: U.S. Department of 
Health and Human Services, Public Health Service, Centers for 
Disease Control and Prevention, National Institute for Occupational 
Safety and Health. DHHS (NIOSH) Publication No. 2009-140.
---------------------------------------------------------------------------

Section 37.52 Proficiency in the Use of Systems for Classifying the 
Pneumoconioses
    Proposed Sec.  37.52(a) and (b), establishing the A and B Reader 
approval programs, would be modified from existing Sec.  37.51 to make 
clarifications in the current requirements and update older 
terminology. Section 37.52(a)(3) would clarify that initial clinical 
interpretations and notification of findings other than pneumoconiosis 
under Sec.  37.51(a) must be provided by a qualified physician who has 
all required licensure and privileges, and interprets chest radiographs 
in the normal course of practice. Proposed Sec.  37.52(b)(1) would 
retain the requirement under existing Sec.  37.51(b)(1) that B Reader 
approval prior to October 1, 1976 be terminated.
    Proposed Sec.  37.52(b)(2) would retain the requirement under 
existing Sec.  37.51(b)(2) that physicians who desire to be B Readers 
demonstrate their proficiency in evaluating chest radiographs by taking 
an examination. The 6-hour initial certification examination was 
commissioned by NIOSH and developed under a contract through the 
American College of Radiology by the Department of Radiology and 
Radiological Science, Johns Hopkins School of Medicine. The test has 
been given about once a month by NIOSH since 1978. Beginning in 1984, 
physicians who wish to maintain B reader status have been required to 
pass a 3-hour recertification examination every 4 years. Examinees for 
recertification who do not obtain a passing grade are permitted to take 
the initial 6-hour certification examination at the next available 
opportunity. Examinees who do not obtain a passing grade on the 6-hour 
certification examination must wait 6 months before they are eligible 
to sit again for the examination. The performance of the examination 
has been described in two manuscripts published in the peer-reviewed 
literature.\32\
---------------------------------------------------------------------------

    \32\ Morgan RH. Proficiency examination of physicians for 
classifying pneumoconiosis chest films. Am J Roentgenology 
1979;132:803-08.
     Wagner GR, Attfield MD, Kennedy RD, Parker JE. The NIOSH B 
Reader Certification Program--An update report. Journal of 
Occupational Medicine. 1992; 34:879-884.
---------------------------------------------------------------------------

    The examination will be based on either film or digital images. The 
existing provision would be modified to indicate that each physician 
desiring to take the digital version of the B Reader examination will 
be provided with a complete set of the NIOSH-approved digital standard 
reference radiographs. NIOSH intends to offer both the film and digital 
versions of the examination for a number of years. A satisfactory grade 
in either examination will qualify the physician to interpret both 
formats. NIOSH has not found that the format of the exam has any effect 
on performance, and finds no justification for requiring that a 
prospective B Reader take both versions of the exam. NIOSH welcomes 
public comment on the potential benefits as well as the disadvantages 
to requiring prospective readers to demonstrate competence in 
classifying both film and digital images.
    Finally, Sec.  37.52(c) would require that physicians who wish to 
participate in the A and B Reader program familiarize themselves with 
the necessary components for attainment of reliable classification of 
chest radiographs for the pneumoconioses. The proposed requirement that 
prospective A and B Readers review NIOSH guidance on radiographic 
classification is included to ensure that each reader has studied 
recommended classification methods

[[Page 1371]]

and approaches. The referenced NIOSH guidance document is newly-
developed and released; \33\ approval as an A or B Reader requires this 
basic level of knowledge.
---------------------------------------------------------------------------

    \33\ NIOSH [2011]. NIOSH Guideline: Application of Digital 
Radiography for the Detection and Classification of Pneumoconiosis. 
DHHS (NIOSH) Publication Number 2011-198. August 2011. http://www.cdc.gov/niosh/docs/2011-198/. Accessed November 16, 2011.
---------------------------------------------------------------------------

    Records pertaining to the provisions in Sec.  37.52 are maintained 
by NIOSH under CDC/ATSDR Privacy Act System of Records Notice 0920-
0001, Certifying Interpreting Physician File.
Section 37.53 Method of Obtaining Definitive Interpretations
    Proposed Sec.  37.53 would maintain the standards in existing Sec.  
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 Sec.  37.53(b); if 
sufficient agreement is lacking, NIOSH shall obtain a third 
interpretation. Text added to Sec.  37.53(a) amends the existing 
provision to clarify procedures in the event that independent 
classifications from three B Readers do not demonstrate sufficient 
agreement. In that case, the final determination would be based upon 
the median (middle) classification of five interpretations derived from 
the three initial readings plus two other classifications from B 
Readers selected from the panel. This provision is intended to codify 
the process used to resolve disagreements among three or more B 
Readers. Text added to Sec.  37.53(b) would clarify that substantial 
agreement is assessed by NIOSH after complete classifications are 
received on either a paper or electronic version of the standard 
Roentgenographic Interpretation Form (Form CDC/NIOSH (M)2.8).
Section 37.54 Notification of Abnormal Radiographic Findings
    Proposed Sec.  37.54, redesignated from Sec.  37.53, would be 
revised to update outdated terminology. The provision would also allow 
the first reader to communicate certain information directly to the 
miner, including abnormal findings other than pneumoconiosis. The 
notification procedure is intended to facilitate and expedite the 
process by which a miner is informed of potentially important medical 
problems and could seek treatment.
    Notification of important results to miners routinely occurs twice, 
providing a particularly robust notification process. The first 
notification is provided by the first physician to review a chest image 
in the community, who is required to provide documentation of miner 
notification to NIOSH. Subsequently, the image is sent to NIOSH and 
reviewed by NIOSH B readers. Within 60 days of completion of the 
physician readings, NIOSH will send a letter to each miner describing 
all findings in layman's terminology, and recommending a specific 
course of action appropriate to the findings. Current regulations 
specify 60 days for receipt of the letters describing pneumoconiosis 
and any other findings. From many years of experience, NIOSH has found 
this time interval to be both appropriate and reasonable. Text for this 
letter is standardized, and has been used by CWHSP for many years. A 
booklet describing local medical and other resources and contact 
information will be included with each letter.
Section 37.60 Submitting Required Chest Radiographs and Miner 
Identification Documents
    Proposed Sec.  37.60 would be essentially unchanged from existing 
Sec.  37.60, which establishes the protocol for submitting radiographs. 
Paragraph (a)(1) would also allow for the submission of image files for 
digital radiographs, and permit the use of either hard copy or 
electronic versions of the forms. We propose to strike the reference to 
a pre-employment physical examination from paragraph (d) to be 
consistent with the requirements of the Americans with Disabilities 
Act.
    Records pertaining to the provisions in Sec.  37.60 are maintained 
by NIOSH under CDC/ATSDR Privacy Act System of Records Notice 0920-
0149, Morbidity Studies in Coal Mining, Metal and Non-Metal Mining and 
General Industry.
Section 37.70 Review of Interpretations
    This section would be amended only to update terminology. Proposed 
Sec.  37.70(a) would retain the existing requirement that, in the 
situation in which a mine plan provides an A reader to perform the 
first reading of a miner's radiograph, a miner may request, and NIOSH 
will obtain, an additional classification of his or her radiograph, 
performed by a B reader. Proposed Sec.  37.70(b) would retain the 
existing requirement that allows a mine operator who is directed by 
MSHA to transfer a miner to a less dusty atmosphere based on a recent 
examination to request that NIOSH review its findings. Terminology in 
both (a) and (b) would be updated.
Section 37.80 Availability of Records for Radiographs
    Proposed Sec.  37.80 would remain unchanged from the existing 
requirement. Terminology in this section would be updated.

B. Subpart--Autopsies

Section 37.200 Scope
    Proposed Sec.  37.200 would remain unchanged from the existing 
explanation that provisions in this subpart establish conditions under 
which pathologists will be paid to conduct autopsies on deceased 
miners.
Section 37.201 Definitions
    Proposed Sec.  37.201 would retain the existing definitions for 
Secretary, miner, and pathologist, but would update ``ALFORD,'' in the 
existing provision to ``NIOSH.''
Section 37.202 Payment for Autopsy
    Proposed Sec.  37.202 would retain the existing provision setting 
forth circumstances under which a pathologist may be paid by the 
Secretary for performing an autopsy.
Section 37.203 Autopsy Specifications
    Proposed Sec.  37.203 would retain the existing standards 
establishing the manner in which autopsies are conducted.
Section 37.204 Procedure for Obtaining Payment
    Proposed Sec.  37.204 would retain the existing procedure for 
submitting a claim for payment to NIOSH (``NIOSH'' would be updated, 
replacing ``ALFORD'').

IV. Regulatory Assessment Requirements

A. Executive Order 12866 and Executive Order 13563

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). E.O. 
13563 emphasizes the importance of quantifying both costs and benefits, 
of reducing costs, of harmonizing rules, and of promoting flexibility.
    This proposed rule is being treated as a ``significant'' action 
under E.O. 12866. It provides for the use of digital radiography 
systems in the Coal Workers' Health Surveillance Program administered 
by NIOSH under 42 CFR

[[Page 1372]]

part 37, in cooperation with coal mine operators, to monitor and 
protect the health of U.S. coal miners, particularly for the prevention 
of CWP. The current regulations at 42 CFR part 37 only allow for the 
use of film-screen radiography systems in this program. The addition of 
digital X-ray standards in part 37 would not require mine operators to 
change their plans to accommodate digital radiographs, but it is 
expected to substantially increase the amount of access miners will 
have to radiograph facilities because the use of film-screen 
radiography is declining markedly throughout the United States and 
specifically in areas where coal mining is located and where coal 
miners live. In fact, many clinics participating in the Program have 
indicated that they are maintaining their outdated X-ray film 
capabilities only because of Program requirements, and that they intend 
to switch to digital radiography when NIOSH allows its use by 
promulgating the rule proposed here. In general, most health care 
facilities have abandoned the use of film-based X-rays. Mammography was 
the last mainstream radiology procedure that required use of film; many 
facilities made the final switch to digital several years ago when 
digital mammography systems became available.
    Increased access to radiograph facilities that offer digital X-rays 
is expected to result in cost savings to coal miners because they will 
not have to drive as far to visit a suitable clinic.
    Digital radiographs are more cost-effective 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 film-screen radiography, including equipment 
maintenance, chemicals, film, and processing. Based on the responses, 
NIOSH believes that the cost to facilities of maintaining film X-ray 
technology to provide radiographs for approximately 2,500 coal miners 
is between $7,000 and $15,000 per clinic per year. Because NIOSH 
expects that most facilities participating in the Program will switch 
entirely to digital radiography when this rule is promulgated, we 
estimate a one-time cost savings to facilities that currently provide 
both film and digital radiographs of between $700,000 and $1,500,000 
after they have discontinued the use of film radiographs. Although this 
rule does not require any facility to upgrade to digital technology, 
facilities that choose to do so will necessarily incur costs associated 
with its acquisition. NIOSH invites public comment on these estimates.
    The proposed rule would not require any radiography facility to 
perform digital radiographs for this NIOSH program. Facilities may 
continue to perform film-screen radiography under the current 
requirements of Part 37 applicable to film-screen radiography, which 
would not be substantially changed by this proposed rule.
    The proposed provisions for using the DICOM standard and 
incorporating by reference standard best practices for digital 
radiography used in lung imaging ensure that the proposed requirements 
reflect standard practice and technology. For these reasons, the rule 
provisions allowing for the use of digital radiography and specifying 
equipment and practice parameters would not impose any additional costs 
on coal mine operators who provide for their miners' participation in 
this program nor on the radiography facilities that serve the 
participating coal miners.
    The proposed rule would establish a new requirement for coal mine 
operators to provide to NIOSH a roster of current miners as proposed 
under Sec.  37.4(a)(3). The provision of this roster to NIOSH is 
current practice by almost all of the approximately 500 U.S. 
underground coal mine operators; therefore codifying this practice in 
regulation will not result in any additional cost to mine operators. 
For these reasons, the proposed rule is not considered economically 
significant, as defined in 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-for-profit organizations. This rule 
would establish standards for the delivery of digitally-acquired chest 
radiographs for underground coal miners. It would not impose any new 
requirements on small radiographic facilities that participate in the 
Coal Workers' Health Surveillance Program administered by NIOSH under 
42 CFR part 37. These facilities may continue to exclusively use film-
screen technology for radiography under provisions that would be 
essentially unchanged by this rulemaking. The rule would benefit these 
facilities by allowing and facilitating their transition to digital 
radiography for the purposes of this program. In this respect, the 
reliance in the proposal on the DICOM standards, standard technology, 
and current best practices for lung imaging radiography ensure that the 
rule is consistent with current medical practices in digital 
radiography. It should also be noted that if this standard permits some 
facilities to switch entirely to digital imaging, rather than 
maintaining two duplicate technologies, the facilities may be able to 
achieve savings in radiography operating costs, as discussed in the 
Executive Orders 12866 and 13563 analysis above. The proposed standard 
would also introduce a substantial benefit in allowing the 
participation in the program of radiography facilities that solely use 
digital radiography; such facilities currently are prohibited from 
participation due to the current lack of digital radiography standards 
for the program under part 37.
    This proposed rule should increase access to medical facilities for 
small and larger coal mine operators, since many medical facilities 
exclusively use digital radiography or are transitioning to this 
technology. The rule may also decrease the cost to coal mine operators 
of providing X-ray screenings to miners. Lower cost is likely to be one 
of the factors in the trend among radiography facilities to adopt or 
switch entirely to digital radiography. In any event, allowing and 
facilitating the provision of digital radiography under part 37 would 
impose no new costs on small coal mine operators.
    The proposed rule would establish a new requirement for coal mine 
operators to provide to NIOSH a roster of current miners as proposed 
under Sec.  37.4(a)(3). The provision of this roster to NIOSH is 
current practice by almost all coal mine operators. NIOSH estimates 
that, of 488 underground coal mines that can be considered small as of 
the first quarter of 2011,\34\ 130 coal mine plans are submitted to the 
Agency annually. NIOSH further estimates that a clerical worker spends 
0.5 hours per year preparing the roster. According to the Bureau of 
Labor Statistics, the average salary of a coal mine clerical worker is 
$17.38/hour; NIOSH estimates the annual cost for an individual coal

[[Page 1373]]

mine operator to supply a roster to NIOSH is approximately $9 and the 
total cost to all coal mines combined amounts to approximately $1170 
annually. In NIOSH's judgment, this $9 cost would not be significant 
for any coal mine operator. Therefore, a regulatory flexibility 
analysis as provided for under the RFA is not required. NIOSH certifies 
that this rule will not have a significant economic impact on a 
substantial number of small entities within the meaning of the RFA.
---------------------------------------------------------------------------

    \34\ U.S. Department of Labor, Mine Safety and Health 
Administration. Mining Industry Accident, Injuries, Employment, and 
Production Data--Address & Employment Self-Extracting Files. http://www.msha.gov/stats/part50/p50y2k/aetable.htm. Accessed July 7, 2011.
---------------------------------------------------------------------------

C. Paperwork Reduction Act

    The Paperwork Reduction Act, 44 U.S.C. 3501 et seq., requires an 
agency to invite public comment on, and to obtain OMB approval of, any 
regulation that requires 10 or more people to report information to the 
agency or to keep certain records. This proposed rule continues to 
impose the same information collection requirements as under the 
current rule, including the submission of the following forms:
     Roentgenographic Interpretation Form [CDC/NIOSH (M)2.8]
     Miner Identification Document [CDC/NIOSH (M)2.9]
     Coal Mine Operator's Plan [CDC/NIOSH (M)2.10]
     Facility Certification Document [CDC/NIOSH (M)2.11]
     Interpreting Physician Certification Document [CDC/NIOSH 
(M)2.12]
     Consent, Release, and History Form [CDC/NIOSH (M)2.6]
    These forms are approved by OMB for data collected under the CWHSP 
(OMB Control No. 0920-0020, exp. June 30, 2014).
    The additional reporting burden associated with the Coal Mine 
Operator's Plan which would require underground coal mine operators to 
submit a roster of current employees (Sec.  37.4(a)(3)), and the 
Facility Certification Document which would be required of 
participating digital radiography facilities (Sec.  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 Sec.  
37.44(g) because this provision reflects standard industry practice and 
does not impose any new recordkeeping requirements.

----------------------------------------------------------------------------------------------------------------
                                                                     Number of                       Response
      Type of respondent          Form name and      Number of     responses per      Hours/        burden  (in
                                       No.          respondents     respondent       response          hrs)
----------------------------------------------------------------------------------------------------------------
Physicians (B Readers)........  Roentgenographic          10,000               1            3/60             500
                                 Interpretation
                                 Form--CDC/NIOSH
                                 (M) 2.8.
Miners........................  Miner                      5,000               1           20/60           1,667
                                 Identification
                                 Document--CDC/
                                 NIOSH (M) 2.9.
Coal Mine Operators...........  Coal Mine                    200               1           30/60             100
                                 Operator's
                                 Plan--CDC/NIOSH
                                 (M) 2.10.
Supervisors at X-ray            Facility                     100               1           30/60              50
 Facilities.                     Certification
                                 Document--CDC/
                                 NIOSH (M) 2.11.
Physicians (B Readers)........  Interpreting                 300               1           10/60              50
                                 Physician
                                 Certification
                                 Document--CDC/
                                 NIOSH (M) 2.12.
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                       50               1            5/60               4
                                 diagnosis).
Next-of-Kin...................  Consent,                      50               1           15/60              13
                                 Release, and
                                 History Form--
                                 CDC.NIOSH (M)
                                 2.6.
                                                 ---------------------------------------------------------------
    Totals....................  ................          23,250  ..............  ..............           4,471
----------------------------------------------------------------------------------------------------------------

D. Small Business Regulatory Enforcement Fairness Act

    As required by Congress under the Small Business Regulatory 
Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), the Department 
will report the promulgation of this rule to Congress prior to its 
effective date. The report will state that the Department has concluded 
that this rule is not a ``major rule'' because it is not likely to 
result in an annual effect on the economy of $100 million or more.

E. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 
et seq.) directs agencies to assess the effects of Federal regulatory 
actions on State, local, and tribal governments, and the private sector 
``other than to the extent that such regulations incorporate 
requirements specifically set forth in law.'' For purposes of the 
Unfunded Mandates Reform Act, this rule does not include any Federal 
mandate that may result in increased annual expenditures in excess of 
$100 million by State, local or tribal governments in the aggregate, or 
by the private sector.

F. Executive Order 12988 (Civil Justice)

    This rule has been drafted and reviewed in accordance with 
Executive Order 12988, ``Civil Justice Reform,'' and will not unduly 
burden the Federal court system. Chest radiograph interpretations that 
result in a finding of pneumoconiosis may be an element in claim 
processing and adjudication conducted by DOL's Black Lung Compensation 
Program. This proposed rule would affect radiographs submitted to DOL 
for the purpose of reviewing and administering those claims. This rule 
has been reviewed carefully to eliminate drafting errors and 
ambiguities.

G. Executive Order 13132 (Federalism)

    The Department has reviewed this rule in accordance with Executive 
Order 13132 regarding federalism, and has determined that it does not 
have ``federalism implications.'' The rule does not ``have substantial 
direct effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.''

H. Executive Order 13045 (Protection of Children From Environmental 
Health Risks and Safety Risks)

    In accordance with Executive Order 13045, HHS has evaluated the 
environmental health and safety effects of this rule on children. HHS 
has determined that the rule would have no effect on children.

[[Page 1374]]

I. Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use)

    In accordance with Executive Order 13211, HHS has evaluated the 
effects of this rule on energy supply, distribution or use, and has 
determined that the rule will not have a significant adverse effect.

J. Plain Writing Act of 2010

    Under Public Law 111-274 (October 13, 2010), executive Departments 
and Agencies are required to use plain language in documents that 
explain to the public how to comply with a requirement the Federal 
Government administers or enforces. HHS has attempted to use plain 
language in promulgating the proposed rule consistent with the Federal 
Plain Writing Act guidelines.

V. Proposed Rule

List of Subjects in 42 CFR Part 37

    Black lung benefits, Incorporation by reference, Lung diseases, 
Mine safety and health, Occupational safety and health, Pneumoconiosis, 
Respiratory and pulmonary diseases, Underground coal mining, Workers' 
compensation, X-rays.

Text of the Rule

    For the reasons discussed in the preamble, the Department of Health 
and Human Services proposes to amend 42 CFR part 37 as follows:

PART 37--SPECIFICATIONS FOR MEDICAL EXAMINATIONS OF UNDERGROUND 
COAL MINERS

    1. The authority citation for part 37 continues to read as follows:

    Authority: Sec. 203, 83 Stat. 763 (30 U.S.C. 843), unless 
otherwise noted.

Subpart--Chest Radiographic Examinations

    2. Revise Sec.  37.1 to read as follows:


Sec.  37.1  Scope.

    The provisions of this subpart set forth the specifications for 
giving, interpreting, classifying, and submitting chest radiographs 
required by section 203 of the Act to be given to underground coal 
miners and new miners.
    3. Revise Sec.  37.2 to read as follows:


Sec.  37.2  Definitions.

    Any term defined in the Federal Mine Safety and Health Act of 1977 
and not defined below shall have the meaning given it in the Act. As 
used in this subpart:
    Act means the Federal Mine Safety and Health Act of 1977 (30 U.S.C. 
801, et seq.).
    Chest radiograph means a single posteroanterior radiographic 
projection or radiograph of the chest at full inspiration recorded on 
either film or digital radiography systems.
    Convenient time and place with respect to the conduct of any 
examination under this subpart means that the examination must be given 
at a reasonable hour in the locality in which the miner resides or a 
location that is equally accessible to the miner. For example, 
examinations at the mine during, immediately preceding, or immediately 
following work and a ``no appointment'' examination at a medical 
facility in a community easily accessible to the residences of a 
majority of the miners working at the mine, shall be considered of 
equivalent convenience for purposes of this paragraph.
    Digital radiography systems, as used in this context, include both 
Digital Radiography (DR) and Computed Radiography (CR).
    (1) Computed radiography (CR) is the term for digital X-ray image 
acquisition systems that detect X-ray signals using a cassette-based 
photostimulable storage phosphor. Subsequently, the cassette is 
processed using a stimulating laser beam to convert the latent 
radiographic image to electronic signals which are then processed and 
stored so they can be displayed.
    (2) Digital radiography (DR) is the term used for digital X-ray 
image acquisition systems in which the X-ray signals received by the 
image detector are converted nearly instantaneously to electronic 
signals without movable cassettes.
    ILO Classification means the below-referenced classification of 
radiographs of the pneumoconioses system devised by an international 
committee of the International Labour Office (ILO), including a 
complete set of standard film radiographs or digital chest image files 
available from the ILO or other set of chest image files accepted by 
NIOSH as equivalent.
    MSHA means the Mine Safety and Health Administration, Department of 
Labor.
    Miner means any individual including any coal mine construction 
worker who is working in or at any underground coal mine, but does not 
include any surface worker who does not have direct contact with 
underground coal mining or with coal processing operations.
    NIOSH means the National Institute for Occupational Safety and 
Health (NIOSH), located within the Centers for Disease Control and 
Prevention (CDC). Within NIOSH, the Division of Respiratory Disease 
Studies (DRDS), Box 4258, Morgantown, WV 26504, formerly called the 
Appalachian Laboratory for Occupational Safety and Health, is the 
organizational unit that has programmatic responsibility for the chest 
radiographic examination program.
    NIOSH representative means employees of CDC/NIOSH and employees of 
CDC contractors.
    Operator means any owner, lessee, or other person who operates, 
controls, or supervises an underground coal mine or any independent 
contractor performing services or construction at such mine.
    Panel of B Readers means the group of physicians that are currently 
approved by NIOSH as B Readers.
    Pre-placement physical examination means any medical examination 
which includes a chest radiographic examination given in accordance 
with the specifications of this Part to a person not previously 
employed by the same operator. Such examinations should be conducted 
consistent with applicable law, including the Americans with 
Disabilities Act of 1990, which provides that pre-placement 
examinations take place only after an offer of employment has been made 
and subject to certain restrictions (42 U.S.C. 12112(d)).
    Qualified medical physicist means an individual who is trained in 
evaluating the performance of radiographic equipment including 
radiation controls and facility quality assurance programs, and has the 
relevant current certification by a competent U.S. national board, or 
unrestricted license or approval from a U.S. state or territory.
    Radiographic technique chart means a table which specifies the 
types of cassette, intensifying screen, film or digital detector, grid, 
filter, and lists 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

[[Page 1375]]

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 Sec.  37.3 to read as follows:


Sec.  37.3  Chest radiographs required for miners.

    (a) Voluntary examinations. Every operator shall provide to each 
miner who is employed in or at any of its underground coal mines and 
who was employed in underground coal mining prior to December 30, 1969, 
or who has completed the required examinations under Sec.  37.3(b) an 
opportunity for a chest radiograph in accordance with this subpart:
    (1) Following August 1, 1978 NIOSH will notify the operator of each 
underground coal mine of a period within which the operator may provide 
examinations to each miner employed at its coal mine. The period shall 
begin no sooner than the effective date of these regulations and end no 
later than a date specified by NIOSH separately for each coal mine. The 
termination date of the period will be approximately 5 years from the 
date of the first examination which was made on a miner employed by the 
operator in its coal mine under the former regulations of this subpart 
adopted July 27, 1973. Within the period specified by NIOSH for each 
mine, the operator may select a 6-month period within which to provide 
examinations in accordance with a plan approved under Sec.  37.5.

    Example: NIOSH finds that between July 27, 1973, and March 31, 
1975, the first radiograph for a miner who was employed at mine Y 
and who was employed in underground coal mining prior to December 
30, 1969, was made on January 1, 1974. NIOSH will notify the 
operator of mine Y that the operator may select and designate on its 
plan a 6-month period within which to offer its examinations to its 
miners employed at mine Y. The 6-month period shall be scheduled 
between August 1, 1978 and January 1, 1979 (5 years after January 1, 
1974).

    (2) For all future voluntary examinations, NIOSH will notify the 
operator of each underground coal mine when sufficient time has elapsed 
since the end of the previous 6-month period of examinations. NIOSH 
will specify to the operator of each mine a period within which the 
operator may provide examinations to its miners employed at its coal 
mine. The period shall begin no sooner than 3\1/2\ years and end no 
later than 4\1/2\ 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 Sec.  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 (3\1/2\ years after December 31, 1979) that the 
operator may select and designate on its plan the next 6-month 
period within which to offer examinations to its miners employed at 
mine Y. The 6-month period shall be scheduled between July 1, 1983, 
and July 1, 1984 (between 3\1/2\ and 4\1/2\ years after December 31, 
1979).

    (3) Within either the next or future period(s) specified by NIOSH 
to the operator for each of its coal mines, the operator of the coal 
mine may select a different 6-month period for each of its mines within 
which to offer examinations. In the event the operator does not submit 
an approved plan, NIOSH will specify a 6-month period to the operator 
within which miners shall have the opportunity for examinations.
    (b) Mandatory examinations. Every operator shall provide to each 
miner who begins working in or at a coal mine for the first time after 
December 30, 1969:
    (1) An initial chest radiograph, as soon as possible, but in no 
event later than 6 months after commencement of employment. An initial 
chest radiograph given to a miner according to former regulations for 
this subpart prior to August 1, 1978 will also be considered as 
fulfilling this requirement.
    (2) A second chest radiograph, in accordance with this subpart, 3 
years following the initial examination if the miner is still engaged 
in underground coal mining. A second radiograph given to a miner 
according to former regulations under this subpart prior to August 1, 
1978 will be considered as fulfilling this requirement.
    (3) A third chest radiograph 2 years following the second chest 
radiograph if the miner is still engaged in underground coal mining and 
if the second radiograph shows evidence of category 1 (1/0, 1/1, 1/2), 
category 2 (2/1, 2/2, 2/3), category 3 (3/2, 3/3, 3/+) simple 
pneumoconioses, or complicated pneumoconioses (ILO Classification).
    (c) NIOSH will notify the miner when he or she is due to receive 
the second or third mandatory examination under (b) of this section. 
Similarly, NIOSH will notify the coal mine operator when the miner is 
to be given a second examination. The operator will be notified 
concerning a miner's third examination only with the miner's written 
consent, and the notice to the operator shall not state the medical 
reason for the examination nor that it is the third examination in the 
series. If the miner is notified by NIOSH that the third mandatory 
examination is due and the operator is not so notified, availability of 
the radiographic examination under the Coal Mine Operator's Plan (Form 
CDC/NIOSH (M)2.10) shall constitute the operator's compliance with the 
requirement to provide a third mandatory examination even if the miner 
refuses to take the examination.
    (d) The opportunity for chest radiographs to be available by an 
operator for purposes of this subpart shall be provided in accordance 
with a plan which has been submitted and approved in accordance with 
this subpart.
    5. Amend Sec.  37.4 by revising paragraphs (a) introductory text, 
(a)(3), (a)(4), (a)(6), (a)(7), and (d) through (f) to read as follows:


Sec.  37.4  Plans for chest radiographic examinations.

    (a) Every plan for chest radiographic examinations of miners shall 
be submitted on the Coal Mine Operator's Plan form (Form CDC/NIOSH 
(M)2.10) to NIOSH within 120 calendar days after August 1, 1978. In the 
case of a person who after August 1, 1978, becomes an operator of a 
mine for which no plan has been approved, that person shall submit a 
plan within 60 days after such event occurs. A separate plan shall be 
submitted by the operator and by each construction contractor for each 
underground coal mine which has a MSHA identification number. The plan 
shall include:
* * * * *
    (3) The proposed beginning and ending date of the 6-month period 
for voluntary examinations (see Sec.  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

[[Page 1376]]

the approximate date(s) and time(s) of day during which the radiographs 
will be given to miners to enable a determination of whether the 
examinations will be conducted at a convenient time and place;
* * * * *
    (6) The name and address of the A or B Reader who will interpret 
and classify the chest radiographs. In the event a plan lists an 
approved facility with a digital radiography system, the name and 
address of the physician(s) who will perform the initial clinical 
interpretation.
    (7) Assurances that:
    (i) The operator will not solicit a physician's radiographic or 
other findings concerning any miner employed by the operator,
    (ii) Instructions have been given to the person(s) giving the 
examinations that duplicate radiographs or copies of radiographs 
(including, for digital radiographs, copies of electronic files) will 
not be made, and to the extent that it is technically feasible for the 
imaging system used, digital radiographs and all related digital files 
shall be permanently deleted from the facility records or rendered 
permanently inaccessible following the confirmed transfer of such data 
to NIOSH, and that (except as may be necessary for the purpose of this 
subpart) the physician's radiographic and other findings, as well as 
the occupational history information obtained from a miner will not be 
disclosed in a manner that would permit identification of the 
individual with their information, and
    (iii) The radiographic examinations will be made at no charge to 
the miner.
* * * * *
    (d) The operator shall advise NIOSH of any change in its plan. Each 
change in an approved plan is subject to the same review and approval 
as the originally approved plan.
    (e) The operator shall promptly display in a visible location on 
the bulletin board at the mine its proposed plan or proposed change in 
plan when it is submitted to NIOSH. The proposed plan or change in plan 
shall remain posted in a visible location on the bulletin board until 
NIOSH either grants or denies approval of it at which time the approved 
plan or denial of approval shall be permanently posted. In the case of 
an operator who is a construction contractor and who does not have a 
bulletin board, the construction contractor must otherwise notify its 
employees of the examination arrangements. Upon request, the contractor 
must show NIOSH written evidence that its employees have been notified.
    (f) Upon notification from NIOSH that sufficient time has elapsed 
since the previous period of examinations, the operator will resubmit 
its plan for each of its coal mines to NIOSH for approval for the next 
period of examinations (see Sec.  37.3(a)(2)). The plan shall include 
the proposed beginning and ending dates of the next period of 
examinations and all information required by paragraph (a) of this 
section.
    6. Revise Sec.  37.5 to read as follows:


Sec.  37.5  Approval of plans.

    (a) If, after review of any plan submitted pursuant to this 
subpart, the Secretary determines that the action to be taken under the 
plan by the operator meets the specifications of this subpart and will 
effectively achieve its purpose, the Secretary will approve the plan 
and notify the operator(s) submitting the plan of the approval. 
Approval may be conditioned upon such terms as the Secretary deems 
necessary to carry out the purpose of section 203 of the Act.
    (b) Where the Secretary has reason to believe that he or she will 
deny approval of a plan the Secretary will, prior to the denial, give 
reasonable notice in writing to the operator(s) of an opportunity to 
amend the plan. The notice shall specify the ground upon which approval 
is proposed to be denied.
    (c) If a plan is denied approval, the Secretary shall advise the 
operator(s) in writing of the reasons for the denial.
    7. Amend Sec.  37.6 by revising paragraphs (a) and (d) to read as 
follows:


Sec.  37.6  Chest radiographic examinations conducted by the Secretary.

    (a) The Secretary will give chest radiographs or make arrangements 
with an appropriate person, agency, or institution to give the chest 
radiographs and with A or B Readers to interpret the radiographs 
required under this subpart in the locality where the miner resides, at 
the mine, or at a medical facility easily accessible to a mining 
community or mining communities, under the following circumstances:
* * * * *
    (d) Operators of mines selected by NIOSH to participate in the 
National Study of Coal Workers' Pneumoconiosis (an epidemiological 
study of respiratory diseases in coal miners) and who agree to 
cooperate will have all their miners afforded the opportunity to have a 
chest radiograph required hereunder at no cost to the operator. For 
future examinations and for mandatory examinations each participating 
operator shall submit an approvable plan.
    8. Amend Sec.  37.7 by revising paragraph (a) to read as follows:


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

    (a) Any miner who, in the judgment of the Secretary based upon the 
interpretation of one or more of the miner's chest radiographs, shows 
category 1 (1/0, 1/1, 1/2), category 2 (2/1, 2/2, 2/3), or category 3 
(3/2, 3/3, 3/+) simple pneumoconioses, or complicated pneumoconioses 
(ILO Classification) shall be afforded the option of transferring from 
his or her position to another position in an area of the mine where 
the concentration of respirable dust in the mine atmosphere is not more 
than 50 percent of the maximum respirable dust concentration permitted 
by MSHA, or if such level is not attainable in the mine, to a position 
in the mine where the concentration of respirable dust is the lowest 
attainable below the maximum respirable dust concentration permitted by 
MSHA.
* * * * *
    9. Revise Sec.  37.8 to read as follows:


Sec.  37.8  Radiographic examination at miner's expense.

    Any miner who wishes to obtain an examination at the miner's own 
expense at an approved facility and to have the complete examination 
submitted to NIOSH may do so, provided that the examination is made no 
sooner than 6 months after the most recent examination of the miner 
submitted to NIOSH. NIOSH will provide an interpretation and report of 
the examinations made at the miner's expense in the same manner as if 
it were submitted under an operator's plan. Any change in the miner's 
transfer rights under the act which may result from this examination 
will be subject to the terms of Sec.  37.7.
    10. Revise Sec.  37.20 to read as follows:


Sec.  37.20  Miner identification document.

    As part of the radiographic examination, a Miner Identification 
Document (Form CDC/NIOSH (M)2.9) which includes an occupational history 
questionnaire shall be completed for each miner at the facility where 
the radiograph is made at the same time the chest radiograph required 
by this subpart is given.
    11. Revise the undesignated center heading and Sec.  37.40 to read 
as follows:

[[Page 1377]]

Specifications for Performing Chest Radiographic Examinations


Sec.  37.40  General provisions.

    (a) The chest radiographic examination shall be given at a 
convenient time and place.
    (b) The chest radiographic examination consists of the chest 
radiograph, and a complete Roentgenographic Interpretation Form (Form 
CDC/NIOSH (M)2.8), and Miner Identification Document (Form CDC/NIOSH 
(M)2.9).
    (c) A radiographic examination shall be made in a facility approved 
in accordance with Sec.  37.43 or Sec.  37.44 by or under the 
supervision of a physician who makes chest radiographs in the normal 
course of practice and who has demonstrated ability to make chest 
radiographs of a quality to best ascertain the presence of 
pneumoconiosis.
    12. Amend Sec.  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:


Sec.  37.41  Chest radiograph specifications--film.

    (a) Miners shall be disrobed from the waist up at the time the 
radiograph is given. The facility shall provide a dressing area and for 
those miners who wish to use one, the facility shall provide a clean 
gown. Facilities shall be heated to a comfortable temperature.
    (b) Every chest radiograph shall be a single posteroanterior 
projection at full inspiration on a film being no less than 14 by 17 
inches and no greater than 16 by 17 inches. The film and cassette shall 
be capable of being positioned both vertically and horizontally so that 
the chest radiograph will include both apices and costophrenic angles. 
If a miner is too large to permit the above requirements, then the 
projection shall include both apices with minimum loss of the 
costophrenic angle.
    (c) Chest radiographs shall be performed by a radiologic 
technologist.
    (d) Radiographs shall be made only with a diagnostic X-ray machine 
having a rotating anode tube with a maximum of a 2 mm source (focal 
spot).
    (e) Except as provided in paragraph (e) of this section, 
radiographs shall be made with units having generators which comply 
with the following:
    (1) The generators of existing radiographic units acquired by the 
examining facility prior to July 27, 1973, shall have a minimum rating 
of 200 mA at 100 kVp;
    (2) Generators of units acquired subsequent to that date shall have 
a minimum rating of 300 mA at 125 kVp.
    (f) Radiographs made with battery-powered mobile or portable 
equipment shall be made with units having a minimum rating of 100 mA at 
110 kVp at 500 Hz, or of 200 mA at 110 kVp at 60 Hz.
    (g) Capacitor discharge and field emission units may be used if the 
model of such units is approved by NIOSH for quality, performance, and 
safety. NIOSH will consider such units for approval when listed by a 
facility seeking approval under Sec.  37.43 or Sec.  37.44 of this 
subpart.
    (h) Radiographs shall be given only with equipment having a beam-
limiting device which does not cause large unexposed boundaries. The 
beam limiting device shall provide rectangular collimation and shall be 
of the type described in 21 CFR 1020.31(d), (e), (f), and (g). The use 
of such a device shall be discernible from an examination of the 
radiograph.
    (i) To ensure high quality chest radiographs:
    (1) The maximum exposure time shall not exceed 50 milliseconds 
except that with single phase units with a rating less than 300 mA at 
125 kVp and subjects with chests over 28 cm posteroanterior, the 
exposure may be increased to not more than 100 milliseconds;
    (2) The source or focal spot to film distance shall be at least 6 
feet;
    (3) Medium speed film and medium speed intensifying screens are 
recommended. However, any film-screen combination, the rated ``speed'' 
of which is at least 100 and does not exceed 300, which produces 
radiographs with spatial resolution, contrast, latitude and quantum 
mottle similar to those of systems designated as ``medium speed'' may 
be employed;
* * * * *
    (7) A suitable grid or other means of reducing scattered radiation 
shall be used;
* * * * *
    (j) * * *
    (2) If mineral or other impurities in the processing water 
introduce difficulty in obtaining a high-quality radiograph, a suitable 
filter or purification system shall be used.
    (k) Before the miner is advised that the examination is concluded, 
the radiograph shall be processed and inspected and accepted for 
quality by the physician, or if the physician is not available, 
acceptance may be made by the radiologic technologist. In a case of a 
substandard radiograph, another shall be immediately made. All 
substandard radiographs shall be clearly marked as rejected and 
promptly sent to NIOSH for disposal.
* * * * *
    (m) A test object may be required on each radiograph for an 
objective evaluation of film quality at the discretion of NIOSH.
    (n) Each radiograph made hereunder shall be permanently and legibly 
marked with the name and address or NIOSH approval number of the 
facility at which it is made, the social security number of the miner, 
and the date of the radiograph. No other identifying markings shall be 
recorded on the radiograph.


Sec. Sec.  37.42 and 37.43  [Redesignated]

    13a. Redesignate Sec. Sec.  37.42 and 37.43 as Sec. Sec.  37.43 and 
37.45 respectively.
    13b. Add new Sec.  37.42 to read as follows:


Sec.  37.42  Chest radiograph specifications--digital radiography 
systems.

    (a) Miners shall be disrobed from the waist up at the time the 
radiograph is given. The facility shall provide a private dressing area 
and for those miners who wish to use one, the facility shall provide a 
clean gown. Facilities shall be heated to a comfortable temperature.
    (b) Every digital chest radiograph taken as required under this 
regulation shall be a single posteroanterior projection at full 
inspiration on a digital detector being no less than 35 by 43 cm (14 by 
17 if measured in inches) and no greater than 41 by 43 cm (16 by 17 
inches). The imaging plate shall have a maximum pixel pitch of 
200[mu]m, and a minimum matrix size of 5 megapixels (for 35 by 43 cm), 
with a minimum bit depth of 10. Spatial resolution shall be at least 
2.5 line pairs per millimeter. The storage phosphor cassette or digital 
image detector shall be positioned either vertically or horizontally so 
that the image includes the apices and costophrenic angles of both 
right and left lungs. If the detector cannot include the apices and 
costophrenic angles of both lungs as described, then two side by side 
images can be obtained which together include the apices and the 
costophrenic angles of both right and left lungs.
    (c) Chest radiographs shall be given by a radiologic technologist.
    (d) Radiographs shall be made with a diagnostic X-ray machine with 
a maximum of a 2 mm source (focal spot).

[[Page 1378]]

    (e) Radiographs shall be made with units having generators which 
have a minimum rating of 300 mA at 125 kVp. Exposure kilovoltage shall 
be at least the minimum as recommended by the manufacturer for chest 
radiography.
    (f) An electric power supply shall be used which complies with the 
voltage, current, and regulation specified by the manufacturer of the 
machine. If the manufacturer or installer of the radiographic equipment 
recommends equipment for control of electrical power fluctuations, such 
equipment shall be used as recommended.
    (g) Radiographs shall be obtained only with equipment having a 
beam-limiting device that does not cause large unexposed boundaries. 
The beam limiting device shall provide rectangular collimation. 
Electronic post-image acquisition ``shutters'' available on some CR and 
DR systems that limit the size of the final image and that simulate 
collimator limits shall not be used. The use and effect of the beam 
limiting device shall be discernible on the resulting image.
    (h) Radiographic technique charts shall be used that are developed 
specifically for the X-ray system and detector combinations used, 
indicating exposure parameters by anatomic measurements.
    (1) If automated exposure control devices are used, performance 
shall be documented by a medical physicist utilizing the image capture 
systems and exposure parameters used at the facility for chest imaging, 
using methods recommended by the American Association of Physicists in 
Medicine in AAPM Report No. 74, Quality Control in Diagnostic 
Radiology, Report of Task Group 12, Diagnostic X-Ray Imaging 
Committee, published by Medical Physics Publishing for AAPM, July 2002, 
pages 17-18, and in AAPM Report No. 14, Performance Specifications and 
Acceptance Testing for X-Ray Generators and Automatic Exposure Control 
Devices, Report of the Diagnostic X-Ray Imaging Committee Task Group on 
Performance Specifications and Acceptance Testing for X-Ray Generators 
and Automatic Exposure Control Devices, published by the American 
Institute of Physics for AAPM, January 1985, pages 61-62. These reports 
are incorporated by reference. The Director of the Federal Register 
approves this incorporation by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. You may obtain a copy of AAPM Report No. 74 
from the AAPM Web site at http://www.aapm.org/pubs/reports/rpt_74.pdf 
or from Medical Physics Publishing, 4513 Vernon Blvd., Madison, WI 
53705. You may obtain a copy of AAPM Report No. 14 from http://www.aapm.org/pubs/reports/rpt_14.pdf or from AAPM, 335 E. 45 Street, 
New York, NY 10017. You may inspect a copy of AAPM Report No. 74 or 
AAPM Report No. 14 at the NIOSH Docket Office, Robert A. Taft 
Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226, or 
at the National Archives and Records Administration (NARA). For 
information on the availability of these materials at NARA, call (202) 
741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (2) Exposure parameters achieved during the evaluation of the 
automated exposure system shall be recorded by the medical physicist in 
a written report or electronic file that is stored at the facility and 
available for inspection by NIOSH for a minimum of 5 years after the 
miner's examination.
    (i) To ensure high quality digital chest radiographs:
    (1) The maximum exposure time shall not exceed 50 milliseconds 
except for subjects with chests over 28 centimeters posteroanterior, 
for whom the exposure time shall not exceed 100 milliseconds;
    (2) The distance from source or focal spot to detector shall be at 
least 70 inches (or 180 centimeters if measured in centimeters);
    (3) The exposure setting for chest images shall be within the range 
of 100-300 equivalent exposure speeds and shall comply with the 
American College of Radiology (ACR) Practice Guideline For Diagnostic 
Reference Levels in Medical X-Ray Imaging, Section V--Diagnostic 
Reference Levels For Imaging With Ionizing Radiation and Section VII--
Radiation Safety in Imaging, Revised 2008 (Res. 3). The ACR Practice 
Guideline is incorporated by reference. The Director of the Federal 
Register approves this incorporation by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy of the ACR 
Practice Guideline from the ACR Web site at http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/med_phys/reference_levels.aspx. You may inspect a copy of the ACR Practice 
Guideline at the NIOSH Docket Office, Robert A. Taft Laboratories, MS-
C34, 4676 Columbia Parkway, Cincinnati, OH 45226, or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call (202) 741-6030 or go to 
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Radiation exposures should be 
periodically measured and patient radiation doses estimated by the 
medical physicist to assure doses are as low as reasonably achievable.
    (4) Digital radiography system performance, including image signal-
to-noise and detective quantum efficiency shall be evaluated and judged 
acceptable by a qualified medical physicist using the specifications of 
the American Association of Physicists in Medicine, AAPM Report No. 93, 
Acceptance Testing and Quality Control of Photostimulable Storage 
Phosphor Imaging Systems, Report of AAPM Task Group 10, published by 
AAPM, October 2006, pages 1-68. This report is incorporated by 
reference. The Director of the Federal Register approves this 
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. You may obtain a copy of AAPM Report No. 93 from the AAPM Web 
site at http://www.aapm.org/pubs/reports/RPT_93.pdf or from AAPM, One 
Physics Ellipse, College Park, MD 20740. You may inspect a copy of AAPM 
Report No. 93 at the NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226, or at the National 
Archives and Records Administration (NARA). For information on the 
availability of these materials at NARA, call (202) 741-6030 or go to 
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Image management software and settings 
for routine chest imaging shall be used, including routine 
amplification of digital detector signal as well as standard image 
post-processing functions. No image or edge enhancement software 
functions shall be employed unless they are integral to the digital 
radiography system (not elective); in such cases, only the minimum 
image enhancement permitted by the system shall be employed.
    (5) (i) The image object, transmission and associated data storage, 
file format, and transmission of associated information shall conform 
to the following components of the National Electrical Manufacturers 
Association's Digital Imaging and Communications in Medicine (DICOM) 
standard:
    (A) Part 3 (PS 3.3-2011): Information Object Definitions, Annex A--
Composite Information Object Definitions, sections: Digital X-Ray Image 
Information Object Definition; X-Ray Radiation Dose SR Information 
Object Definition; and Grayscale Softcopy Presentation State 
Information Object Definition.

[[Page 1379]]

    (B) Part 4 (PS3.4-2011): Service Class Specifications, sections: 
Annex B--Storage Service Class; Annex N--Softcopy Presentation State 
Storage SOP Classes; Annex O--Structured Reporting Storage SOP Classes.
    (C) Part 10 (PS 3.10-2011): Media Storage and File Format for Data 
Interchange.
    (D) Part 11 (PS 3.11-2011): Media Storage Application Profiles.
    (E) Part 12 (PS 3.12-2011): Media Formats and Physical Media for 
Media Interchange.
    (F) Part 14 (PS 3.14-2011): Grayscale Standard Display Function.
    (G) Part 16 (PS 3.16-2011): Content Mapping Resource, section: X-
Ray Radiation Dose SR IOD Templates.
    (ii) The sections of the DICOM standard indicated above are 
incorporated by reference. The Director of the Federal Register 
approves this incorporation by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. You may obtain a copy of the DICOM standard 
from the NEMA Web site at ftp://medical.nema.org/medical/dicom/2011/ or 
from the National Electrical Manufacturers Association, 1300 N. 17th 
Street, Rosslyn, VA 22209. You may inspect a copy of the DICOM standard 
at the NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 
Columbia Parkway, Cincinnati, OH 45226, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
these materials at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (A) Identification of each miner, chest image, facility, date and 
time of the examination shall be encoded within the image information 
object, according to Part 3 (PS 3.3-2011) of the DICOM standard, 
Information Object Definitions, for the DICOM ``DX'' object. Part 3 is 
incorporated by reference and is available as indicated above. If data 
compression is performed, it shall be lossless. Exposure parameters 
(kVp, mA, time, beam filtration, scatter reduction, radiation exposure) 
shall be stored in the DX information object.
    (B) Exposure parameters as defined in the DICOM Standard PS 3.16-
2011: Content Mapping Resource, shall additionally be provided, when 
such parameters are available from the facility digital image 
acquisition system or recorded in a written report or electronic file 
and either transmitted to NIOSH or stored at the facility and available 
for inspection by NIOSH for 5 years after the examination.
    (6) A specific test object may be required on each radiograph for 
an objective evaluation of image quality at the discretion of NIOSH.
    (7) CR imaging plates shall be inspected at least once a month and 
cleaned when necessary by the method recommended by the manufacturer;
    (8) A grid or air gap for reducing scattered radiation shall be 
used; grids shall not be used that cause Moir[eacute] interference 
patterns in either horizontal or vertical images.
    (9) The geometry of the radiographic system shall ensure that the 
central axis (ray) of the primary beam is perpendicular to the plane of 
the CR imaging plate, or DR detector and is correctly aligned to the 
grid;
    (10) Radiographs shall not be made when the environmental 
temperatures and humidity in the facility are outside the 
manufacturer's recommended range of the CR and DR equipment to be used.
    (11) Before the miner is advised that the examination is concluded, 
the radiograph shall be processed and inspected and accepted for 
quality by the physician, or if the physician is not available, 
acceptance may be made by the radiologic technologist. In a case of a 
substandard radiograph, another shall be made immediately. Unacceptable 
digital image files shall be fully deleted immediately or rendered 
permanently inaccessible in the event that permanent deletion is not 
technologically feasible.
    (j) The following are not authorized for use under this section:
    (1) Digital images derived from film screen chest radiographs 
(e.g., by scanning or digital photography); or
    (2) Images that were acquired using digital systems and then 
printed on transparencies for back-lighted display (e.g., using 
tradition view boxes).
    14. Revise newly designated Sec.  37.43 to read as follows:


Sec.  37.43  Approval of radiographic facilities that use film.

    (a) Facilities become eligible to participate in this program by 
demonstrating their ability to make high quality diagnostic chest 
radiographs by submitting to NIOSH six or more sample chest radiographs 
made and processed at the applicant facility and which are of 
acceptable quality to one or more individuals selected by NIOSH from 
the panel of B Readers. Applicants shall also submit a radiograph of a 
plastic step-wedge object \1\ or other test object (available on loan 
from NIOSH) which was made and processed at the same time with the same 
technique as the radiographs submitted and processed at the facility 
for which approval is sought. At least one chest radiograph and one 
test object radiograph shall have been made with each unit to be used 
hereunder. All radiographs shall have been made within 15 calendar days 
prior to submission and shall be marked to identify the facility where 
each radiograph was made, the X-ray machine used, and the date each was 
made. The chest radiographs will be returned and may be the same 
radiographs submitted pursuant to Sec.  37.50.
---------------------------------------------------------------------------

    \1\ The plastic step-wedge object is described in Trout ED, 
Kelley JP [1973]. A phantom for the evaluation of techniques and 
equipment used for roentgenography of the chest. Amer J Roentgenol 
117(4):771-776.
---------------------------------------------------------------------------

    (b) Each radiographic facility submitting chest radiographs for 
approval under this section shall complete and include an X-ray 
Facility Certification Document (Form CDC/NIOSH (M) 2.11) describing 
each X-ray unit to be used to make chest radiographs under the Act. The 
form shall include:
    (1) The date of the last radiation safety inspection by an 
appropriate licensing agency or, if no such agency exists, by a 
qualified expert as defined in NCRP Report No. 102 (see Sec.  37.45);
    (2) The deficiencies found;
    (3) A statement that all the deficiencies have been corrected; and
    (4) The date of acquisition of the X-ray unit. To be acceptable, 
the radiation safety inspection shall have been made within 1 year 
preceding the date of application.
    (c) Radiographs submitted with applications for approval under this 
section will be evaluated by one or more individuals selected by NIOSH 
from the panel of B Readers or by a qualified medical physicist or 
consultant. Applicants will be advised of any reasons for denial of 
approval.
    (d) NIOSH or its representatives may make a physical inspection of 
the applicant's facility and any approved radiographic facility at any 
reasonable time to determine if the requirements of this subpart are 
being met.
    (e) NIOSH may require a facility periodically to resubmit 
radiographs of a test object, sample radiographs, or a Facility 
Certification Document for quality control purposes. Approvals granted 
hereunder may be suspended or withdrawn by notice in writing when in 
the opinion of NIOSH the quality of radiographs or information 
submitted under this section warrants such action. A copy of a notice 
withdrawing approval will be sent to each operator who has listed the 
facility as its facility for giving chest radiographs and shall be 
displayed on the mine bulletin board adjacent to the operator's 
approved

[[Page 1380]]

plan. The approved plan will be reevaluated by NIOSH in light of this 
change.
    (f) A formal written quality assurance program shall be established 
at each facility addressing radiation exposures, equipment maintenance, 
and image quality, and shall conform to the standards set by the 
American Association of Physicists in Medicine in AAPM Report No. 74, 
Quality Control in Diagnostic Radiology, Report of Task Group 
12, Diagnostic X-Ray Imaging Committee, published by Medical 
Physics Publishing for AAPM, July 2002, pages 1-19, 47-53, and 56. This 
report is incorporated by reference. The Director of the Federal 
Register approves this incorporation by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy of AAPM Report 
No. 74 from the AAPM Web site at http://www.aapm.org/pubs/reports/rpt_74.pdf or from Medical Physics Publishing, 4513 Vernon Blvd., Madison, 
WI 53705. You may inspect a copy of AAPM Report No. 74 at the NIOSH 
Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia 
Parkway, Cincinnati, OH 45226, or at the National Archives and Records 
Administration (NARA). For information on the availability of these 
materials at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (g) In conducting medical examinations pursuant to this Part, 
physicians and radiographic facilities shall maintain the results and 
analysis of these examinations (including any hard copies or digital 
files containing individual data, interpretations, and images) 
consistent with applicable statutes and regulations governing the 
treatment of individually identifiable health information, including, 
as applicable, the HIPAA Privacy and Security Rules (45 CFR part 160 
and subparts A, C, and E of part 164).
    15. Add Sec.  37.44 to read as follows:


Sec.  37.44  Approval of radiographic facilities that use digital 
radiography systems.

    (a) Applications for facility approval.
    (1) Facilities seeking approval shall demonstrate the ability to 
make high quality digital chest radiographs by submitting to NIOSH 
digital radiographic image files of a test object (e.g., a plastic 
step-wedge or chest phantom which will be provided on loan from NIOSH) 
as well as digital radiographic image files from six or more sample 
chest radiographs which are of acceptable quality to (1) one or more 
individuals selected by NIOSH from the panel of B Readers and (2) a 
qualified medical physicist or consultant, both designated by NIOSH. 
Image files shall be submitted on standard portable media (compact or 
digital video disc) and formatted to meet specifications of the Digital 
Imaging and Communications in Medicine (DICOM) standard for diagnostic 
media interchange Part 12 (PS 3.12-2011): Media Formats and Physical 
Media for Media Interchange. Applicants will be advised of any reasons 
for denial of approval. All submitted images shall be made within 60 
days prior to the date of application using the same technique, 
equipment, and software as will be used by the facility under the 
requested approval. At least six chest radiographs and one test object 
radiograph shall have been made with each digital radiographic unit to 
be used by the facility under the requested approval. The corresponding 
radiographic image files shall be submitted on standard portable media 
(compact or digital video disc) and formatted to meet specifications of 
the current Digital Imaging and Communications in Medicine (DICOM) 
standard for diagnostic media interchange Part 12 (PS 3.12-2011): Media 
Formats and Physical Media for Media Interchange. DICOM Part 12 is 
incorporated by reference. The Director of the Federal Register 
approves this incorporation by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. You may obtain a copy of the DICOM standard 
from the NEMA Web site at ftp://medical.nema.org/medical/dicom/2011/ or 
from the National Electrical Manufacturers Association, 1300 N. 17th 
Street, Rosslyn, VA 22209. You may inspect a copy of the DICOM standard 
at the NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 
Columbia Parkway, Cincinnati, OH 45226, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this document at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Documentation shall include the following: the identity 
of the facility where each radiograph was made; the X-ray machine used; 
and the model, version, and production date of each image acquisition 
software program and hardware component. The submitted sample digital 
chest image files shall include at least two taken with the detector in 
the vertical position and two in the horizontal position where the 
imaging system permits these positions, and at least two chest images 
shall be from persons within the highest quartile of chest diameters 
(28 cm or greater).
    (2) Each radiographic facility submitting chest radiographic image 
files for approval under this section shall complete and include an X-
ray Facility Certification Document (Form CDC/NIOSH (M)2.11) describing 
each X-ray system component, and the models and versions of image 
acquisition hardware and software to be used to make digital chest 
radiographs under the Act. The form shall include:
    (i) A copy of a dated report signed by a qualified medical 
physicist, documenting the evaluation of radiation safety and 
performance characteristics specified in this regulation for each 
digital radiography system;
    (ii) A copy of the report of the most recent radiation safety 
inspection by a licensing agency, if such agency exists;
    (iii) A listing of all deficiencies noted in either of the reports;
    (iv) A statement that all the listed deficiencies have been 
corrected; and
    (v) The names and relevant training and experience of facility 
personnel described in paragraphs (b), (d), and (e) of this section. To 
be acceptable, the report by the medical physicist and radiation safety 
inspection specified in this paragraph shall have been made within 1 
year prior to the date of submission of the application.
    (b) Facilities shall maintain ongoing licensure and certification 
under relevant local, State, and Federal laws and regulations for all 
digital equipment and related processes covered under this Part.
    (c) NIOSH or its representatives may make a physical inspection of 
the applicant's facility and any approved radiographic facility at any 
reasonable time to determine if the requirements of this subpart are 
being met.
    (d) NIOSH may periodically require a facility to resubmit 
radiographic image files of the NIOSH-supplied test object (e.g., step-
wedge or chest phantom), sample radiographs, or a Facility 
Certification Document. Approvals granted to facilities under this 
section may be suspended or withdrawn by notice in writing when, in the 
opinion of NIOSH, deficiencies in the quality of radiographs or 
information submitted under this section warrant such action. A copy of 
a notice suspending or withdrawing approval will be sent to each 
operator that has listed the facility for its use under this Part and 
shall be displayed on the mine bulletin board adjacent to the 
operator's approved plan. The operator's approved plan may be 
reevaluated by NIOSH in response to such suspension or withdrawal.

[[Page 1381]]

    (e) A qualified medical physicist who is familiar with the facility 
hardware and software systems for image acquisition, manipulation, 
display, and storage, shall be on site or available as a consultant. 
The physicist shall be trained in evaluating the performance of 
radiographic equipment and facility quality assurance programs, and 
shall be licensed/approved by a State or territory of the United States 
or certified by a competent U.S. national board.
    (f) Facilities shall document that testing performed by a qualified 
medical physicist has verified that performance of each image 
acquisition system for which approval is sought met initial 
specifications and standards of the equipment manufacturer and 
performance testing as required under paragraphs (b), (e), and (g) of 
this section.
    (g) A formal written quality assurance program shall be established 
at each facility addressing radiation exposures, equipment maintenance, 
and image quality, and shall conform to the standards set by the 
American Association of Physicists in Medicine in AAPM Report No. 74, 
Quality Control in Diagnostic Radiology, Report of Task Group 
12, Diagnostic X-Ray Imaging Committee, published by Medical 
Physics Publishing for AAPM, July 2002, pages 1-19, 47-53, and 56, and 
AAPM Report No. 116, An Exposure Indicator for Digital Radiography, 
Report of AAPM Task Group 116, published by AAPM, July 2009, sections 
VIII, IX, and X. These reports are incorporated by reference. The 
Director of the Federal Register approves this incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may 
obtain a copy of AAPM Report No. 74 from the AAPM Web site at http://www.aapm.org/pubs/reports/rpt_74.pdf or from Medical Physics 
Publishing, 4513 Vernon Blvd., Madison, WI 53705. You may obtain a copy 
of AAPM Report No. 116 from the AAPM Web site at http://www.aapm.org/pubs/reports/RPT_116.PDF or from American Association of Physicists in 
Medicine, One Physics Ellipse, College Park, MD 20740. You may inspect 
a copy of AAPM Report No. 74 and No. 116 at the NIOSH Docket Office, 
Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, 
OH 45226, or at the National Archives and Records Administration 
(NARA). For information on the availability of these materials at NARA, 
call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (1) Applications for facility approval shall include a 
comprehensive assessment by a qualified medical physicist within 12 
months prior to application addressing the performance of X-ray 
generators, automatic exposure controls, and image capture systems. The 
assessment shall comply with the following guidelines: American 
Association of Physicists in Medicine, AAPM Report No. 93, Acceptance 
Testing and Quality Control of Photostimulable Storage Phosphor Imaging 
Systems, Report of AAPM Task Group 10, published by AAPM, October 2006, 
pages 1-68; AAPM Report No. 74, Quality Control in Diagnostic 
Radiology, Report of Task Group 12, Diagnostic X-Ray Imaging 
Committee, published by Medical Physics Publishing for AAPM, July 2002, 
page 6-11; and AAPM Report No. 14, Performance Specifications and 
Acceptance Testing for X-Ray Generators and Automatic Exposure Control 
Devices, Report of the Diagnostic X-Ray Imaging Committee Task Group on 
Performance Specifications and Acceptance Testing for X-Ray Generators 
and Automatic Exposure Control Devices, published by the American 
Institute of Physics, January 1985, pages 1-96. These reports are 
incorporated by reference. The Director of the Federal Register 
approves this incorporation by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. You may obtain a copy of AAPM Report No. 93 
from the AAPM Web site at http://www.aapm.org/pubs/reports/RPT_93.pdf 
or from the American Association of Physicists in Medicine, One Physics 
Ellipse, College Park, MD 20740. You may obtain a copy of AAPM Report 
No. 74 from the AAPM Web site at http://www.aapm.org/pubs/reports/rpt_74.pdf or from Medical Physics Publishing, 4513 Vernon Blvd., Madison, 
WI 53705. You may obtain a copy of AAPM Report No.14 from the AAPRM Web 
site at http://www.aapm.org/pubs/reports/rpt_14.pdf or from the 
Executive Secretary, American Association of Physicists in Medicine, 
335 E. 45 Street, New York, NY 10017. A copy of AAPM Reports No. 93, 
74, and 14 may be inspected at the NIOSH Docket Office, Robert A. Taft 
Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226, or 
at the National Archives and Records Administration (NARA). For 
information on the availability of these materials at NARA, call (202) 
741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (2) Radiographic technique charts shall be used that are developed 
specifically for the X-ray system and detector combinations used, 
indicating exposure parameters by anatomic measurements. If automated 
exposure control devices are used, calibration for chest imaging shall 
be documented using the actual voltages and image capture systems. 
Radiological exposures resulting from at least ten (randomly selected) 
digital chest images obtained at the facility shall be monitored at 
least quarterly to detect and correct potential dose creep, using 
methods specified in: American Association of Physicists in Medicine in 
AAPM Report No. 31, Standardized Methods for Measuring Diagnostic X-Ray 
Exposures, Report of Task Group 8, Diagnostic X-Ray Imaging Committee, 
published by the American Institute of Physics, March 2005. This report 
is incorporated by reference. The Director of the Federal Register 
approves this incorporation by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. You may obtain a copy of AAPM Report No. 31 
from the AAPM Web site at http://www.aapm.org/pubs/reports/RPT_31.pdf 
or from the American Institute of Physics, c/o AIDC, 64 Depot Road, 
Colchester, VT 05446. A copy of AAPM Report No. 31 may be inspected at 
the NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 
Columbia Parkway, Cincinnati, OH 45226, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
these materials at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Radiation exposures shall be compared to a 
professionally accepted reference level published in the American 
College of Radiology (ACR) Practice Guideline For Diagnostic Reference 
Levels in Medical X-Ray Imaging, Revised 2008 (Res. 3), pages 1-6. The 
ACR Practice Guideline is incorporated by reference. The Director of 
the Federal Register approves this incorporation by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a 
copy of the ACR Practice Guideline from the ACR Web site at http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/med_phys/reference_levels.aspx. You may inspect a copy of the ACR 
Practice Guideline at the NIOSH Docket Office, Robert A. Taft 
Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226, or 
at the National Archives and Records Administration (NARA). For 
information on the availability of this

[[Page 1382]]

material at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. 
In addition, the medical physicist shall submit an annual assessment of 
measured or estimated radiation exposures, with specific recommended 
actions to minimize exposures during examinations performed under this 
Part.
    (3) For each digital radiography device and system, performance 
shall be monitored annually in accordance with the recommendations of 
AAPM Report No. 93, except for the testing specifically excluded below. 
Documentation shall be maintained on the completion of quality 
assurance testing, including the reproducibility of X-ray output, 
linearity and reproducibility of mA settings, accuracy and 
reproducibility of timer and kVp settings, accuracy of source-to-
detector distance, and X-ray field focal spot size, selection, beam 
quality, congruence and collimation. For DR systems, the following 
tests listed in AAPM Report No. 93, Acceptance Testing and Quality 
Control of Photostimulable Storage Phosphor Imaging Systems, 2006, are 
not required under this Part:

(i) Section 8.4.5: Laser beam function
(ii) Section 8.4.9: Erasure Thoroughness
(iii) Section 8.4.11: Imaging Plate (IP) Throughput

    (4) Facilities shall maintain documentation, available for 
inspection by NIOSH for 5 years, of the ongoing implementation of 
policies and procedures for monitoring and evaluating the effective 
management, safety, and proper performance of chest image acquisition, 
digitization, processing, compression, transmission, display, 
archiving, and retrieval functions of digital radiography devices and 
systems.
    (h) In conducting medical examinations pursuant to this Part, 
physicians and radiographic facilities shall maintain the results and 
analysis of these examinations (including any hard copies or digital 
files containing individual data, interpretations, and images) 
consistent with applicable statutes and regulations governing the 
treatment of individually identifiable health information, including, 
as applicable, the HIPAA Privacy and Security Rules (45 CFR Part 160 
and Subparts A, C, and E of Part 164).
    16. Revise newly designated Sec.  37.45 to read as follows:


Sec.  37.45  Protection against radiation emitted by radiographic 
equipment.

    Except as otherwise specified in Sec.  37.41 and Sec.  37.42, 
radiographic equipment, its use and the facilities (including mobile 
facilities) in which such equipment is used, shall conform to 
applicable State or territorial and Federal regulations. Where no 
applicable regulations exist, radiographic equipment, its use and the 
facilities (including mobile facilities) in which such equipment is 
used shall conform to the recommendations of the National Council on 
Radiation Protection and Measurements in NCRP Report No. 102, Medical 
X-ray, Electron Beam, and Gamma-Ray Protection for Energies Up to 50 
MeV, Equipment Design, Performance, and Use, 1989; NCRP Report No. 105, 
Medical Radiation Protection for Medical and Allied Health Personnel, 
1989; and in NCRP Report No. 49, Structural Shielding Design and 
Evaluation for Medical Use of X-Rays and Gamma Rays of Energies up to 
10 MeV, 1976. These documents are incorporated by reference. The 
Director of the Federal Register approves this incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may 
obtain a copy of the NCRP reports from NCRP Publications, 7910 Woodmont 
Avenue, Suite 400, Bethesda, MD 20814-3095, Telephone (800) 229-2652 or 
from http://www.ncrponline.org/Publications/Publications.html. You may 
inspect a copy of the ACR Practice Guideline at the NIOSH Docket 
Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, 
Cincinnati, OH 45226, or at the National Archives and Records 
Administration (NARA). For information on the availability of these 
materials at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    17. Revise the undesignated center heading and Sec.  37.50 to read 
as follows:

Specifications for Interpretation, Classification, and Submission of 
Chest Radiographs


Sec.  37.50  Interpreting and classifying chest radiographs--film.

    (a) Chest radiographs shall be interpreted and classified in 
accordance with the International Labour Office (ILO) International 
Classification of Radiographs for Pneumoconioses, 2011. The ILO 
Classification is incorporated by reference. The Director of the 
Federal Register approves this incorporation by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51. You may purchase a copy of the 
ILO Classification from ILO Publications, International Labour Office, 
CH-1211 Geneva 22, Switzerland, or from the ILO Web site at http://www.ilo.org/publns. You may inspect the ILO Classification at the NIOSH 
Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia 
Parkway, Cincinnati, OH 45226, or at the National Archives and Records 
Administration (NARA). For information on the availability of these 
materials at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Chest radiograph interpretations and classifications 
shall be recorded on a paper or electronic Roentgenographic 
Interpretation Form (Form CDC/NIOSH (M)2.8).
    (b) Radiographs shall be interpreted and classified only by a 
physician who reads chest radiographs in the normal course of practice 
and who has demonstrated proficiency in classifying the pneumoconioses 
in accordance with Sec.  37.52.
    (1) Initial clinical interpretations and notification of findings 
other than pneumoconiosis under Sec.  37.50(a) shall be provided by a 
qualified physician who has all required licensure and privileges, and 
interprets chest radiographs in the normal course of practice.
    (c) All interpreters, whenever interpreting chest radiographs made 
under the Act, shall have immediately available for reference a 
complete set of the ILO International Classification of Radiographs for 
Pneumoconioses, 2011.
    (d) In all view boxes used for making interpretations:
    (1) Fluorescent lamps shall be simultaneously replaced with new 
lamps at 6-month intervals;
    (2) All the fluorescent lamps in a panel of boxes shall have 
identical manufacturer's ratings as to intensity and color;
    (3) The glass, internal reflective surfaces, and the lamps shall be 
kept clean;
    (4) The unit shall be so situated as to minimize front surface 
glare.


Sec. Sec.  37.51-37.53  [Redesignated]

    18a. Redesignate Sec. Sec.  37.51 through 37.53 as Sec. Sec.  37.52 
through 37.54 respectively.
    18b. Add new Sec.  37.51 to read as follows:


Sec.  37.51  Interpreting and classifying chest radiographs--digital 
radiography systems.

    (a) For each chest radiograph obtained at an approved facility 
using a digital radiography system, a qualified and licensed physician 
who reads chest radiographs in the normal course of practice shall 
provide an initial clinical interpretation and notification, as

[[Page 1383]]

specified in Sec.  37.54, of any significant abnormal findings other 
than pneumoconiosis.
    (b) Chest radiographs shall be classified for pneumoconiosis by 
physician readers who have demonstrated ongoing proficiency, as 
specified in Sec.  37.52(b), in classifying the pneumoconioses in a 
manner consistent with the ILO International Classification of 
Radiographs of Pneumoconioses 2011. The ILO Classification is 
incorporated by reference. The Director of the Federal Register 
approves this incorporation by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. You may purchase a copy of the ILO 
Classification from ILO Publications, International Labour Office, CH-
1211 Geneva 22, Switzerland, or from the ILO Web site at http://www.ilo.org/publns. You may inspect the ILO Classification at the NIOSH 
Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia 
Parkway, Cincinnati, OH 45226, or at the National Archives and Records 
Administration (NARA). For information on the availability of these 
materials at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Chest radiograph interpretations and classifications 
shall be recorded on a paper or electronic Roentgenographic 
Interpretation Form (Form CDC/NIOSH (M)2.8).
    (c) All interpreters, whenever classifying digitally-acquired chest 
radiographs made under the Act, shall have immediately available for 
reference a complete set of NIOSH-approved standard digital chest 
radiographic images provided for use with the ILO International 
Classification of Radiographs of Pneumoconioses, 2011. Only NIOSH-
approved standard digital images shall be used for classifying digital 
chest images for pneumoconiosis. Modification of the appearance of the 
standard images using software tools is not permitted.
    (d) Viewing systems should enable readers to display the coal 
miner's chest image at the full resolution of the image acquisition 
system, side-by-side with the selected NIOSH-approved standard images 
for comparison.
    (1) Image display devices shall be flat panel monitors displaying 
at least 3 MP at 10 bit depth. Image displays and associated graphics 
cards shall meet the calibration and other specifications of the 
National Electrical Manufacturers Association's Digital Imaging and 
Communications in Medicine (DICOM) standard Part 14 (PS 3.14-2011): 
Grayscale Standard Display Function. DICOM Part 14 is incorporated by 
reference. The Director of the Federal Register approves this 
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. You may obtain a copy of the DICOM standard from the NEMA Web 
site at ftp://medical.nema.org/medical/dicom/2011/or from the National 
Electrical Manufacturers Association, 1300 N. 17th Street, Rosslyn, VA 
22209. You may inspect a copy of the DICOM standard at the NIOSH Docket 
Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, 
Cincinnati, OH 45226, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
document at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    Image displays and associated graphics cards shall not deviate by 
more than 10 percent from the grayscale standard display function 
(GSDF) when assessed according the American Association of Physicists 
in Medicine (AAPM) On-Line Report No. 03, Assessment of Display 
Performance for Medical Imaging Systems, Task Group 18, Imaging 
Informatics Subcommittee, published by AAPM, April 2005, pages 1-146. 
This report is incorporated by reference. The Director of the Federal 
Register approves this incorporation by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy of On-Line 
Report No. 03 from American Association of Physicists in Medicine, One 
Physics Ellipse, College Park, MD 20740 or from http://www.aapm.org/pubs/reports/OR_03.pdf. You may inspect a copy of AAPM On-Line Report 
No. 03 at the NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 
4676 Columbia Parkway, Cincinnati, OH 45226, or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this document at NARA, call (202) 741-6030 or go to 
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (2) Display system luminance (maximum and ratio), relative noise, 
linearity, modulation transfer function (MTF), frequency, and glare 
should meet or exceed recommendations listed in AAPM On-Line Report No. 
03, Assessment of Display Performance for Medical Imaging Systems, Task 
Group 18, Imaging Informatics Subcommittee, published by AAPM, April 
2005, pages 1-146. This report is incorporated by reference. The 
Director of the Federal Register approves this incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may 
obtain a copy of On-Line Report No. 03 from American Association of 
Physicists in Medicine, One Physics Ellipse, College Park, MD 20740 or 
from http://www.aapm.org/pubs/reports/OR_03.pdf. You may inspect a 
copy of AAPM On-Line Report No. 03 at the NIOSH Docket Office, Robert 
A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, OH 
45226, or at the National Archives and Records Administration (NARA). 
For information on the availability of this document at NARA, call 
(202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Viewing displays 
shall have a maximum luminance of at least 171 cd/m\2\, a ratio of 
maximum luminance to minimum luminance of at least 250, and a glare 
ratio greater than 400. The contribution of ambient light reflected 
from the display surface, after light sources have been minimized, 
shall be included in luminance measurements.
    (3) Displays shall be situated so as to minimize front surface 
glare. Readers shall minimize reflected light from ambient sources 
during the performance of classifications.
    (4) Measurements of the width and length of pleural shadows and the 
diameter of opacities shall be taken using calibrated software 
measuring tools. If permitted by the viewing software, a record shall 
be made of the presentation state(s), including any noise reduction and 
edge enhancement or restoration functions that were used in performing 
the classification, including any annotations and measurements.
    (e) Quality control procedures for devices used to display chest 
images for classification shall comply with the recommendations of the 
American Association of Physicists in Medicine AAPM On-Line Report No. 
03, Assessment of Display Performance for Medical Imaging Systems, Task 
Group 18, Imaging Informatics Subcommittee, published by AAPM, April 
2005, pages 1-146. This report is incorporated by reference. The 
Director of the Federal Register approves this incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may 
obtain a copy of On-Line Report No. 03 from American Association of 
Physicists in Medicine, One Physics Ellipse, College Park, MD 20740 or 
from http://www.aapm.org/pubs/reports/OR_03.pdf. You may inspect a 
copy of AAPM On-Line Report No. 03 at the

[[Page 1384]]

NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia 
Parkway, Cincinnati, OH 45226, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
document at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (1) If automatic quality assurance systems are used, visual 
inspection shall be performed using one or more test patterns 
recommended by the medical physicist every 6 months, or more 
frequently, to check for defects that automatic systems may not detect.
    (2) [Reserved]
    (f) Classification of CR and DR digitally-acquired chest 
radiographs under this Part shall be performed based on the viewing of 
images displayed as soft copies using the viewing workstations 
specified in this section. Classification of radiographs shall not be 
based on the viewing of hard copy printed transparencies of images that 
were digitally-acquired.
    (g) The classification chest radiographs based on digitized copies 
of chest radiographs that were originally acquired using film-screen 
techniques is not permissible under this Part.
    19. Revise newly designated Sec.  37.52 to read as follows:


Sec.  37.52  Proficiency in the use of systems for classifying the 
pneumoconioses.

    (a) First or A Readers:
    (1) Approval as an A Reader shall continue if established prior to 
the effective date of these regulations.
    (2) Physicians who desire to be A Readers must demonstrate their 
proficiency in classifying the pneumoconioses by either:
    (i) Submitting to NIOSH from the physician's files six sample chest 
radiographs which are considered properly classified by one or more 
individuals selected by NIOSH from the panel of B Readers. The six 
radiographs shall consist of two without pneumoconiosis, two with 
simple pneumoconiosis, and two with complicated pneumoconiosis (these 
may be the same radiographs submitted for facility approval pursuant to 
Sec.  37.43 and Sec.  37.44). The films will be returned to the 
physician. The interpretations shall be on the Roentgenographic 
Interpretation Form (Form CDC/NIOSH (M)2.8), or;
    (ii) Satisfactory completion, since June 11, 1970, of a course 
approved by NIOSH on the ILO International Classification of 
Radiographs of Pneumoconioses.
    (b) Final or B Readers:
    (1) Approval as a B Reader established prior to October 1, 1976, 
shall hereby be terminated.
    (2) Proficiency in evaluating chest radiographs for radiographic 
quality and in the use of the ILO Classification for interpreting chest 
radiographs for pneumoconiosis and other diseases shall be demonstrated 
by those physicians who desire to be B Readers by taking and passing a 
specially-designed proficiency examination given on behalf of or by 
NIOSH at a time and place specified by NIOSH. Each physician who 
desires to take the digital version of the examination will be provided 
a complete set of the current NIOSH-approved standard reference digital 
radiographs. Physicians who qualify under this provision need not be 
qualified under paragraph (a) of this section.
    (c) Physicians who wish to participate in the program shall 
familiarize themselves with the necessary components for attainment of 
reliable classification of chest radiographs for the pneumoconioses \2\ 
and apply using an Interpreting Physician Certification Document (Form 
CDC/NIOSH (M)2.12).
---------------------------------------------------------------------------

    \2\ NIOSH Safety and Health Topic. Chest Radiography: 
Radiographic Classification [http://www.cdc.gov/niosh/topics/chestradiography/radiographic-classification.html]. Date accessed: 
January 25, 2011.
---------------------------------------------------------------------------

    20. Revise newly designated Sec.  37.53 to read as follows:


Sec.  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 Sec.  37.52. If there is agreement between the two interpretations, 
as described in paragraph (b) of this section, the result shall be 
considered final and reported to MSHA for transmittal to the miner. 
When agreement is lacking, NIOSH shall obtain a third interpretation 
from the panel of B Readers. If any two of the three interpretations 
demonstrate agreement, the result shall be considered the final 
determination. If agreement is lacking among the three interpretations, 
NIOSH will obtain independent classifications from two additional B 
Readers selected from the panel, and the final determination will be 
the median category derived from the total of five classifications.
    (b) Two interpretations shall be considered to be in agreement when 
they are derived from complete classifications recorded using approved 
paper or electronic versions of the Roentgenographic Interpretation 
Form (Form CDC/NIOSH (M)2.8) and received by NIOSH, and both find 
either stage A, B, or C complicated pneumoconiosis, or, for simple 
pneumoconiosis, are both in the same major category or (with one 
exception noted below) are within one minor category (ILO 
Classification 12-point scale) of each other. In the last situation, 
the higher of the two interpretations shall be reported. The only 
exception to the one minor category principle is a reading sequence of 
0/1, 1/0, or 1/0, 0/1, which is not considered agreement.
    21. Revise newly designated Sec.  37.54 to read as follows:


Sec.  37.54  Notification of abnormal radiographic findings.

    (a) Findings of, or findings suggesting, enlarged heart, 
tuberculosis, lung cancer, or any other significant abnormal findings 
other than pneumoconiosis shall be communicated by the first physician 
to interpret the radiograph to the miner or to the designated physician 
of the miner indicated on the Miner Identification Document. A notice 
of the communication shall be submitted to NIOSH. NIOSH will also 
notify the miner to contact his or her physician when any physician who 
interprets and classifies the miner's radiograph reports significant 
abnormal findings other than pneumoconiosis.
    (b) In addition, when NIOSH has more than one radiograph of a miner 
in its files and the most recent examination was interpreted to show 
enlarged heart, tuberculosis, cancer, complicated pneumoconiosis, and 
any other significant abnormal findings, NIOSH will submit all of the 
miner's radiographs in its files with their respective interpretations 
to a B Reader. The B Reader will report any significant changes or 
progression of disease or other comments to NIOSH and NIOSH shall 
submit a copy of the report to the miner or to the miner's designated 
physician.
    (c) All final findings regarding pneumoconiosis will be sent to the 
miner by MSHA in accordance with section 203 of the Act (see 30 CFR 
part 90). Positive findings with regard to pneumoconiosis will be 
reported to the miner or to the miner's designated physician by NIOSH.
    (d) NIOSH will make every reasonable effort to process the findings 
described in paragraph (c) of this section within 60 days of receipt of 
the information described in Sec.  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

[[Page 1385]]

an examination made of a miner may not be processed by NIOSH if the 
examination was made within 6 months of the date of a previous 
acceptable examination.
    22. Amend Sec.  37.60 by revising paragraphs (a) through (d) to 
read as follows:


Sec.  37.60  Submitting required chest radiographs and miner 
identification documents.

    (a) Each chest radiograph required to be made under this subpart, 
together with the completed Roentgenographic Interpretation Form and 
the completed Miner Identification Document, shall be submitted 
together for each miner to NIOSH within 14 calendar days after the 
radiographic examination is given and become the property of NIOSH.
    (1) When the radiograph is digital, the image file for each 
radiograph, together with either hard copy or electronic versions of 
the completed Roentgenographic Interpretation Form and the completed 
Miner Identification Document, shall be submitted to NIOSH using the 
software and format specified by NIOSH either using portable electronic 
media, or a secure electronic file transfer within 14 calendar days 
after the radiographic examination. NIOSH will notify the submitting 
facility when it has received the image files and forms from the 
examination. After this notification, the facility will permanently 
delete, or if this is not technologically feasible for the imaging 
system used, render permanently inaccessible all files and forms from 
its electronic and physical files.
    (2) [Reserved]
    (b) If NIOSH deems any submission under paragraph (a) of this 
section inadequate, it will notify the operator of the deficiency. The 
operator shall promptly make appropriate arrangements for the necessary 
reexamination.
    (c) Failure to comply with paragraph (a) or (b) of this section 
shall be cause to revoke approval of a plan or any other approval as 
may be appropriate. An approval which has been revoked may be 
reinstated at the discretion of NIOSH after it receives satisfactory 
assurances and evidence that all deficiencies have been corrected and 
that effective controls have been instituted to prevent a recurrence.
    (d) Chest radiographs and other required documents shall be 
submitted only for miners.
* * * * *
    23. Revise Sec.  37.70 to read as follows:


Sec.  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 Sec.  37.53, 
and MSHA shall report the results to the miner together with 
notification from MSHA of any rights which may accrue to the miner in 
accordance with Sec.  37.7. If the reported interpretation was based on 
agreement between two (or more) B Readers, the reading will be accepted 
as conclusive and the miner shall be so informed by MSHA.
    (b) Any operator who is directed by MSHA to transfer a miner to a 
less dusty atmosphere based on the most recent examination made 
subsequent to August 1, 1978, may file a written request with NIOSH to 
review its findings. The standards set forth in paragraph (a) of this 
section apply and the operator and miner will be notified by MSHA 
whether the miner is entitled to the option to transfer.
    24. Revise Sec.  37.80 to read as follows:


Sec.  37.80  Availability of records for radiographs.

    (a) Medical information and radiographs on miners will be released 
by NIOSH only with the written consent from the miner, or if the miner 
is deceased, written consent from the miner's widow or widower, next of 
kin, or legal representative.
    (b) To the extent authorized, radiographs will be made available 
for examination only at NIOSH.
    25. Amend Sec.  37.201 by revising paragraph (d) to read as 
follows:


Sec.  37.201  Definitions.

* * * * *
    (d) NIOSH means the National Institute for Occupational Safety and 
Health, United States Public Health Service, Department of Health and 
Human Services, Post Office Box 4258, Morgantown, WV 26504.
    26. Amend Sec.  37.202 by revising paragraphs (a)(2) and (b) to 
read as follows:


Sec.  37.202  Payment for autopsy.

    (a) * * *
    (2) Submits the findings and other materials to NIOSH in accordance 
with this subpart within 180 calendar days after having performed the 
autopsy; and
* * * * *
    (b) The Secretary will pay to any pathologist entitled to payment 
under paragraph (a) of this section and additional $10 if the 
pathologist can obtain and submits a good quality copy or original of a 
chest radiograph (posteroanterior view) made of the subject of the 
autopsy within 5 years prior to his death together with a copy of any 
interpretation made.
    26. Amend Sec.  37.204 by revising the introductory text and 
paragraph (b), and removing Figure 1, to read as follows:


Sec.  37.204  Procedure for obtaining payment.

    Every claim for payment under this subpart shall be submitted to 
NIOSH and shall include:
* * * * *
    (b) Completed PHS Consent, Release and History form (Form CDC/NIOSH 
(M)2.6). This form may be completed with the assistance of the 
pathologist, attending physician, family physician, or any other 
responsible person who can provide reliable information.
* * * * *

    Dated: October 11, 2011.
Kathleen Sebelius,
Secretary.
[FR Doc. 2011-33164 Filed 1-6-12; 8:45 am]
BILLING CODE 4163-18-P