```

[Federal Register Volume 77, Number 178 (Thursday, September 13, 2012)]
[Rules and Regulations]
[Pages 56717-56735]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22253]

[[Page 56717]]

Vol. 77

Thursday,

No. 178

September 13, 2012

Part II

Department of Health and Human Services

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

42 CFR Part 37

Specifications for Medical Examinations of Underground Coal Miners; 
Final Rule

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

[[Page 56718]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 37

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

Specifications for Medical Examinations of Underground Coal 
Miners

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Final rule.

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

SUMMARY: This final rule modifies the Department of Health and Human 
Services (HHS) regulations for medical examinations of underground coal 
miners. Existing regulations established specifications for providing, 
interpreting, classifying, and submitting film-based roentgenograms 
(now commonly called chest radiographs or X-rays) of underground coal 
miners. The revised standards modify the requirements to permit the use 
of film-based radiography systems and add a parallel set of standards 
permitting the use of digital radiography systems. An additional 
amendment requires coal mine operators to provide the National 
Institute for Occupational Safety and Health (NIOSH) with employee 
rosters to assist the Coal Workers' Health Surveillance Program in 
improving participation by miners.

DATES: This final rule is effective October 15, 2012. The incorporation 
by reference of certain publications listed in the rule is approved by 
the Director of the Federal Register as of October 15, 2012.

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

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

Table of Contents

I. Public Participation
II. Background
    A. Scope of Rulemaking
    B. Impact of Rulemaking
III. Summary of Final Rule and Response to Public Comments
    A. Subpart--Chest Radiographic Examinations
    B. Subpart--Autopsies
IV. Regulatory Assessment Requirements
    A. Executive Orders 12866 and 13563
    B. Regulatory Flexibility Act
    C. Paperwork Reduction Act
    D. Small Business Regulatory Enforcement Fairness Act
    E. Unfunded Mandates Reform Act of 1995
    F. Executive Order 12988 (Civil Justice)
    G. Executive Order 13132 (Federalism)
    H. Executive Order 13045 (Protection of Children From 
Environmental Health Risks and Safety Risks)
    I. Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use)
    J. Plain Writing Act of 2010
V. Final Rule

I. Public Participation

    HHS received comments from 11 individuals and organizations. Four 
of the commenters are B Readers; two are West Virginia physicians; one 
is a private citizen; and one is a U.S. Senator. Comments were also 
submitted on behalf of the National Council on Radiation Protection and 
Measurements (NCRP), the American Society of Radiologic Technologists, 
and a law firm representing two coal companies and the West Virginia 
Coal Workers' Pneumoconiosis Fund.

II. Background

    All mining work generates fine particles of dust in the air. Coal 
miners who inhale excessive dust are known to develop a group of 
diseases of the lungs and airways, including chronic bronchitis, 
emphysema, chronic obstructive pulmonary disease, silicosis, and coal 
workers' pneumoconiosis (CWP).\1\ To address such threats to the U.S. 
coal mining workforce, the Coal Mine Health and Safety Act was enacted 
in 1969 (Pub. L. 91-173) and amended by the Federal Mine Safety and 
Health Act of 1977 (Pub. L. 95-164, 30 U.S.C. 801 et seq.) (Mine Act). 
The statutes included an enforceable 2 milligrams per cubic meter limit 
on respirable dust exposure during underground coal mine work (30 
U.S.C. 842(b)(2)). The science available at that time indicated that 
enforcement of this limit would greatly reduce the development of CWP, 
but could not ensure that all miners would be protected from developing 
disabling or lethal disease.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    The NIOSH Coal Workers' Health Surveillance Program (CWHSP), also 
mandated by the Mine Act, was developed to detect CWP and prevent 
progression in individual miners, while at the same time providing 
information for evaluation of temporal and geographic trends in 
pneumoconiosis. The Mine Act grants NIOSH general authority to issue 
regulations as the Institute deems appropriate in carrying out 
provisions of the Act and specifically directs that medical 
examinations for underground coal miners shall be given in accordance 
with specifications prescribed by NIOSH (30 U.S.C. 843(a), 957).
    To inform each miner of his or her health status, the Act requires 
that underground coal mine operators offer new workers a chest 
roentgenogram (hereafter chest radiograph or X-ray) through an approved 
facility as soon as possible after employment starts. Three years later 
a miner must be offered a second chest radiograph. If this second 
examination reveals evidence of pneumoconiosis, the miner is entitled 
to a third chest radiograph 2 years after the second. Further, all 
miners working in an underground coal mine must be offered a chest 
radiograph approximately every 5 years. All chest radiographs are to be 
given in accordance with specifications prescribed by the Secretary of 
Health and Human Services (30 U.S.C. 843(a)).
    Chest radiographs taken for the CWHSP are assessed by qualified and 
licensed physicians who are A or B Readers. A Readers are physicians 
who interpret chest radiographs for clinical purposes. They will have 
demonstrated knowledge of the International Labour Office (ILO) 
Classification of Radiographs of Pneumoconioses by completing a NIOSH-
approved course or submitting six radiographs with satisfactory 
classifications, as specified in 42 CFR 37.51. B Readers are physicians 
who have demonstrated proficiency in the use of the ILO classification 
system by taking and passing a specially-designed proficiency 
examination offered by NIOSH, as specified in 42 CFR 37.51.
    HHS proposed amendments to the existing part 37 regulations in a 
document published in January, 2012 (77 FR 1360, January 9, 2012).

A. Scope of Rulemaking

    Existing regulations under 42 CFR part 37 provide rules and 
specifications for giving, interpreting, classifying, and submitting 
chest radiographs as required under section 203 of the Federal Mine 
Safety and Health Act of 1977, as amended (30 U.S.C. 843). Those rules 
will remain in effect. This rulemaking does not substantially alter the 
current standards.
    Significantly, the new rule expands the availability of chest 
radiographic examinations by establishing additional

[[Page 56719]]

options for giving, interpreting, classifying, and submitting 
digitally-acquired radiographs under the same scope as the existing 
rule does for film radiographs. The final rule establishes the minimum 
specifications for methods, procedures, quality assurance, 
documentation, and equipment including computer software for facilities 
seeking approval to perform and submit digital radiographic 
examinations as well as the physician readers who interpret, classify, 
and submit reports using those radiographs. The final rule also makes 
limited changes to general requirements to reflect current terminology 
(such as the use of ``radiograph'' instead of ``roentgenogram'' which 
is no longer commonly used), practice or needs, such as requiring mine 
operators to provide a roster of current miners to NIOSH, which uses 
this information to promote miner participation in the Coal Workers' 
Health Surveillance Program. The final rule does not modify existing 
requirements for miner radiographic examinations, eligibility, or other 
rights, including transfer of affected miners in accordance with 30 CFR 
part 90.

B. Impact of Rulemaking

    The U.S. Department of Labor (DOL) will likely amend its Black Lung 
Benefits Act (BLBA) program regulations to correspond with this final 
rule. The BLBA provides disability compensation and medical benefits to 
miners disabled by pneumoconiosis and monthly compensation to their 
eligible survivors (30 U.S.C. 901-944). Because DOL is required to 
consult with NIOSH on the development of criteria for medical tests for 
coal miners (30 U.S.C. 902(f)(1)(D)), DOL has modeled its technical 
requirements for chest radiographs on those adopted by NIOSH for the 
Coal Workers' Health Surveillance Program (see 20 CFR 718.102 and 20 
CFR part 718 Appendix A). DOL's Occupational Safety and Health 
Administration (OSHA) might enable the use of digital chest images for 
medical surveillance under its asbestos regulations for general 
industry, shipyard employment, and construction (29 CFR 1910.1001 
Appendix E, 29 CFR 1915.1001 Appendix E, and 29 CFR 1926.1101 Appendix 
E, respectively). OSHA's asbestos regulations include requirements for 
screening asbestos-exposed individuals using chest radiography. 
Enabling the use of modern digital chest imaging in that setting will 
involve similar technical considerations as are addressed in this final 
rule. However, OSHA's asbestos regulations are not linked by statute or 
regulation to this final rule.
    The DOL standards refer to chest ``roentgenograms,'' an outdated 
term which NIOSH is replacing with the more contemporary 
``radiograph.'' The DOL standards also rely upon the same ILO standards 
for the classification of radiographs, and might need to be amended to 
comport with the 2011 version of the ILO Classification, as referenced 
in this final rule. Finally, the DOL standards refer to film-based 
images and might need to be expanded to refer to digitally-acquired 
images in order to allow for such images to be used for purposes of 
determining eligibility for compensation.

III. Summary of Final Rule and Response to Public Comments

    This final rule establishes new requirements for digital 
radiography under existing part 37 of 42 CFR--Specifications for 
Medical Examinations of Underground Coal Miners. The new provisions 
supplement and update the existing requirements for film-screen 
radiographs by establishing standards for digital radiographs. The 
following is a section-by-section introduction to each rule section, 
including a summary of the public comments and NIOSH responses to them. 
In general, the commenters are supportive of this rulemaking and 
welcome its implementation. Commenters offered thoughtful and practical 
suggestions for improvement of the final rule text, and HHS has adopted 
many of those suggestions.
    Table 1 matches the current regulatory provisions with the 
corresponding final provisions. The final regulatory text is provided 
in the last section of this notice.

                  Table 1--Current and Final Provisions
------------------------------------------------------------------------
           Current regulation                    Final regulation
------------------------------------------------------------------------
37.2 Definitions.......................  37.2 Definitions.
37.3 Chest roentgenograms required for   37.3 Chest radiographs required
 miners.                                  for miners.
37.4 Plans for chest roentgenographic    37.4 Plans for chest
 examinations.                            radiographic 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 less  37.7 Transfer of affected miner
 dusty area.                              to less dusty area.
37.8 Roentgenographic examination at     37.8 Radiographic examination
 miner's expense.                         at miner's expense.
                                         37.10 Standards incorporated by
                                          reference.
37.20 Miner identification document....  37.20 Miner identification
                                          document.
37.40 General provisions...............  37.40 General provisions.
37.41 Chest roentgenogram                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 equipment.   facilities that use film.
                                         37.44 Approval of radiographic
                                          facilities that use digital
                                          radiography systems.
                                         37.45 Protection against
                                          radiation emitted by
                                          radiographic equipment.
37.50 Interpreting and classifying       37.50 Interpreting and
 chest roentgenogram.                     classifying chest radiographs--
                                          film.
37.51 Proficiency in the use of systems  37.51 Interpreting and
 for classifying the pneumoconioses.      classifying chest radiographs--
                                          digital radiography systems.
37.52 Method of obtaining definitive     37.52 Proficiency in the use of
 interpretations.                         systems for classifying the
                                          pneumoconioses.
37.53 Notification of abnormal           37.53 Method of obtaining
 roentgeno graphic 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 Availability of records.
37.200 Scope...........................  37.200 Scope.

[[Page 56720]]

 
37.201 Definitions.....................  37.201 Definitions.
37.202 Payment for autopsy.............  37.202 Payment for autopsy.
37.203 Autopsy specifications..........  37.203 Autopsy specifications.
37.204 Procedure for obtaining payment.  37.204 Procedure for obtaining
                                          payment.
------------------------------------------------------------------------

Section 37.1 Scope

    This existing section provides the scope of these provisions, and 
remains unchanged from the current regulation. HHS received no comments 
on this section.

Section 37.2 Definitions

    HHS amends a number of terms in the existing Sec.  37.2 to reflect 
updated terminology and references.
    Comment: One commenter supports and agrees with the definition of 
``radiologic technologist'' included in Section 37.2 but suggests that 
the definition contained in this section be amended to require the 
individual to have ``completed a formal training program in radiography 
leading to a certificate, an associate degree, or a bachelor's degree 
and participated in the voluntary initial certification and annual 
renewal of registration for radiologic technologists in radiography 
offered by the American Registry of Radiologic Technologists.'' The 
definition proposed by HHS would make those credentials ``optimal,'' 
but not required.
    HHS response: HHS considers the described training, certification, 
and ongoing renewals as optimum for radiologic technologists. However, 
because State and Territorial governments have regulatory authority for 
oversight of radiologic technologists, the Federal government cannot 
require such credentials. Accordingly, the commenter's suggestion 
cannot be implemented.

Section 37.3 Chest Radiographs Required for Miners

    This existing section requires mine operators to provide miners an 
opportunity to receive a chest radiograph. HHS amends this provision to 
delete and replace outdated text. HHS received no comments on Sec.  
37.3.

Section 37.4 Plans for Chest Radiographic Examinations

    This existing section requires that mine operators submit to NIOSH 
a Coal Mine Operator's Plan (Form CDC/NIOSH (M)2.10, OMB 0920-0020, 
exp. June 30, 2014) for chest radiographic examinations, including the 
beginning and ending dates of the 6-month period for voluntary 
examinations, and the name and location of the approved X-ray facility 
or facilities. HHS received no comments on Sec.  37.4.

Section 37.5 Approval of Plans

    This existing section outlines the process undertaken by the 
Secretary of HHS to approve or deny approval of a Coal Mine Operator's 
Plan (Form CDC/NIOSH (M)2.10, OMB 0920-0020, exp. June 30, 2014). HHS 
amends this section to redact outdated text and to correct gender-
exclusive language. HHS received no comments on Sec.  37.5.

Section 37.6 Chest Radiographic Examinations Conducted by the Secretary

    This existing section details the conditions under which the HHS 
Secretary will determine whether to conduct a chest radiographic 
examination. HHS amends this section to replace outdated text with 
current terminology. HHS received no comments on Sec.  37.6.

Section 37.7 Transfer of Affected Miner to Less Dusty Area

    Under 30 CFR part 90, miners whose radiographs show specific 
categories of pneumoconiosis are offered the right to frequent 
workplace dust monitoring, and transfer to another position in an area 
of the mine where the concentration of respirable dust in the mine 
atmosphere is in compliance with MSHA requirements in 30 CFR 90.3. HHS 
received no comments on Sec.  37.7.

Section 37.8 Radiographic Examination at Miner's Expense

    This existing section provides for any miner who wishes to obtain a 
radiographic examination at his or her own expense. HHS received no 
comments on Sec.  37.8.

Section 37.10 Standards Incorporated by Reference

    HHS has added Sec.  37.10 to consolidate all of the standards 
incorporated by reference in Part 37. There are no substantive changes 
to the referenced standards.

Section 37.20 Miner Identification Document

    This existing section requires the completion of a Miner 
Identification Document (Form CDC/NIOSH (M)2.9, OMB 0920-0020, exp. 
June 30, 2014) for each miner when the chest radiograph is made. HHS 
received no comments on Sec.  37.20.

Section 37.40 General Provisions

    This existing section outlines general provisions for chest 
radiographic examinations. HHS received no comments on Sec.  37.40. 
However, paragraph (c) is edited to indicate that a radiograph may also 
be performed by a radiologic technologist to comport with the 
requirements in Sec. Sec.  37.41 and 37.42.

Section 37.41 Chest Radiograph Specifications--Film

    This existing section establishes performance standards for the 
acquisition of chest radiographs using film-screen technology. HHS 
amends this section to update terminology and standards. In response to 
comments, discussed below, subsection (c) is amended to require that 
chest radiographs be performed by either a physician or a person 
working under the supervision of a physician, or by a radiologic 
technologist. Subsection (d) is amended in response to a comment to 
Sec.  31.42, below, to specify that the size of the focal spot should 
be described as the measured size and not the nominal size. Subsection 
(n) is also amended in response to comments (see below) to require that 
each radiograph be marked with the miner's date of birth, in addition 
to the identification of the facility where it was made, the miner's 
Social Security number, and the date on which the X-ray was made.
    Comment: One commenter supports the change to subsection (c), 
requiring that a radiologic technologist perform chest radiography 
using film. According to the commenter, a registered radiologic 
technologist in radiography is educationally prepared and clinically 
competent to perform chest radiography. Several commenters do not 
approve of the proposed requirement, asserting that when radiographs of 
miners under this regulation are taken

[[Page 56721]]

by State approved and licensed radiology facilities in a physician's 
office or clinic and that X-ray is performed under the direct 
supervision of a facility medical or osteopathic physician, it is not 
necessary to employ a radiology technician. Commenters state that 
allowing other trained professionals to make radiographs will improve 
the availability of surveillance health examination in mining regions.
    HHS response: The intent of the wording in this section is to 
assure that coal miners are provided high quality radiographic 
examinations using professionally-accepted methods that minimize 
radiation exposure. In order to optimize quality, safety, and 
accessibility goals, the wording of Sec.  37.41(c) has been edited to 
indicate that the X-ray may be made either a physician or a person 
working under the supervision of a physician, or by a radiologic 
technologist.
    Comment: One commenter states that use of Social Security number as 
an identifier is increasingly difficult. The individual suggests that 
for examinations under this regulation, the image file or DICOM header 
include the date of birth of the individual whose chest is imaged.
    HHS response: HHS concurs and has accordingly modified the 
regulatory text in Sec.  37.41(n) to require that the X-ray also be 
marked with the miner's date of birth.

Section 37.42 Chest Radiograph Specifications--Digital Radiography 
Systems

    This new section establishes performance standards for the 
acquisition of chest radiographs using digital radiography systems, 
including digital radiography and computed radiography. Section 
37.42(b), (c), (d), and (i)(4) is amended in response to comments, as 
discussed below. Section 37.42(i)(5)(i)(A) is amended to include DICOM 
Standard PS 3.3-2001, Annex A, Computed Radiography Image Information 
Object Definition. This section title was inadvertently omitted, and 
references an image information object which was already a required 
component of older CR equipment models.
    Comment: One commenter notes that the regulations ``do not require 
certification that the individual digital image taken both complied 
with the specifications of 42 CFR 37.42 and that the facility where the 
digital image was taken has been approved, and that its approval was 
current under 42 CFR 37.44, when the digital image was taken.'' The 
comment suggests either the recording form be revised or alternatively, 
a web-based listing of NIOSH-approved radiographic facilities be made 
available.
    HHS response: CWHSP will continue to maintain a web-based listing 
of radiographic facilities that are NIOSH-approved under 42 CFR part 
37, including directions and maps to locate approved facilities. (See, 
http://www.cdc.gov/niosh.)
    Comment: One commenter indicates that the size of the detector 
specified in Sec.  37.42(b) would exclude one prominent equipment 
provider, and also would unnecessarily prohibit use of larger 
detectors. The commenter further suggests that the specification of a 5 
megapixel matrix size be eliminated since the requirements for pixel 
pitch and detector size are sufficient, and these are not entirely 
consistent with the specified matrix size. The commenter further 
expresses concern that the requirement that ``Spatial resolution shall 
be at least 2.4 line pair per millimeter'' is not adequately defined. 
The commenter offers several methods to clarify the requirement, 
including the suggestion that the modulation transfer function be 
included in the system performance requirements in Sec.  37.42(i)(4).
    HHS response: In response to this comment, the text of the final 
rule is modified to specify only pixel pitch and detector size, without 
a specific matrix size. Specifically, HHS has omitted the proposed 
maximum size for image detectors. The final rule text now specifies a 
minimum area and width for detectors which will accommodate the 
equipment mentioned in the comment (Sec.  37.42(b)). Per the 
commenter's suggestion, Sec.  37.42(i)(4) is also amended to address 
the modulation transfer function (MTF). However, HHS reminds 
stakeholders that under Sec.  37.42(i)(6), NIOSH retains the discretion 
to evaluate image quality by requiring the facility to include a test 
object on each X-ray.
    Comment: One commenter states that when radiographs of miners under 
this regulation are taken by State-approved and licensed radiology 
facilities in a physician's office or clinic and that X-ray is 
performed under the direct supervision of a facility medical or 
osteopathic physician, it is not necessary to employ a radiologic 
technologist (Sec.  37.42(c)).
    HHS Response: In order to optimize quality, safety, and 
accessibility goals, the wording of Sec.  37.42(c) has been edited to 
indicate that the X-ray may be made by either a physician or a person 
working under the supervision of a physician, or by a radiologic 
technologist.
    Comment: A commenter suggests that, in relation to the 
specifications for X-ray generators in 37.42(d), the size of the focal 
spot should be described as the measured size and not the nominal size.
    HHS response: HHS has amended the final rule text to specify the 
measured, rather than nominal width of the focal point. A similar 
change is made to Sec.  37.41(d), specifications for film radiographs.
    Comment: One commenter suggests that the application of edge 
enhancement techniques in image processing may result in inaccurate 
appearances and emphasizes the importance of using full uncompressed 
DICOM image files, and requiring medical grade monitors (Sec.  
37.42(i)).
    HHS response: HHS concurs with the commenter and believes that the 
provisions in Sec.  37.42(i) appropriately restrict use of edge 
enhancement techniques, require compression of DICOM image files to be 
fully reversible (lossless), and stipulate that the image display 
devices must meet the Grayscale Standard Display Function for 
diagnostic monitors specified in DICOM Part 14.
    Comment: One commenter recommends that Sec.  37.42(i)(5)(ii)(A) be 
amended to require that the image file or DICOM header include the date 
of birth of the individual whose chest is imaged. Another commenter 
indicates that determining whether imaging parameters have been met 
will be difficult because only basic information is contained in the 
DICOM header, thus placing a burden on small hospitals attempting to 
comply with quality assurance standards.
    HHS response: HHS concurs that the miner's date of birth should be 
required for film radiographs. For digital radiographs, unique 
identification of each miner, chest image, facility, and date and time 
of the examination are encoded within the image information object 
according to Part 3 (PS 3.3-2009) of the DICOM standard, as specified 
in Sec.  37.42. Accordingly, HHS has not amended the text of Sec.  
37.42(i)(5)(ii)(A).
    With regard to the quality assurance standards, since the inception 
of the Program, there has been a continuing concern for both safety and 
image properties, and quality assurance has always been a component of 
the 42 CFR Part 37 specifications. In this final rule, this 
professionally recommended and prudent element is being extended to 
cover the newly permitted digital imaging systems.
    Comment: A commenter expresses concern that images will be rejected 
and deleted even if, due to emergency situations, patients may be 
elderly, too

[[Page 56722]]

ill for a high quality standard PA image, etc. The commenter further 
states that all images have useful information, and that no images 
should be discarded (Sec.  37.42(i)(11)).
    HHS response: The rule allows each physician reader to maintain his 
or her individual professional judgment in determining the quality of 
an image that is to be classified. The rule does not specifically 
require deletion of image files, but requires that when an image is 
deemed suboptimal and imaging is immediately repeated to obtain a 
better quality image, the original suboptimal file be fully deleted or 
rendered permanently inaccessible. The requirement to delete image 
files after they are transferred to NIOSH or if found substandard and 
thus immediately repeated is entirely analogous to the current rules 
regarding destruction of copies of film radiographs, and is only 
intended to assure maintenance of worker confidentiality for 
participants in the mandated Program. Approved facilities are permitted 
to forward to NIOSH all files of chest radiographic examinations that 
they have performed for any eligible coal miner, independent of image 
quality.

Section 37.43 Approval of Radiographic Facilities That Use Film

    Section 37.43 comprises the current requirements in existing Sec.  
37.42--Approval of roentgenographic facilities. HHS received no 
comments on Sec.  37.43.

Section 37.44 Approval of Radiographic Facilities That Use Digital 
Radiography Systems

    Section 37.44 establishes standards for the approval of 
radiographic facilities that use digital radiography systems. These 
standards mirror those for film-screen technology.
    Comment: A commenter states that it is the position of the American 
Society of Radiologic Technologists that radiographic technique charts 
be used by persons performing radiography and that all health care 
facilities make radiographic technique charts available to persons 
performing radiography. The commenter is pleased to see this position 
reflected by the inclusion of the provision in Sec.  37.44(g)(2) along 
with the requirement that facilities have in place a documented quality 
assurance program.
    HHS response: HHS appreciates this comment.

Section 37.45 Protection Against Radiation Emitted by Radiographic 
Equipment

    This provision requires that radiographic equipment conform to 
applicable State, territorial, and Federal regulations. Where no State, 
Territorial or Federal regulations apply, the section incorporates by 
reference the recommendations of the National Council on Radiation 
Protection and Measurements (NCRP).
    Comment: A commenter representing the NCRP provided updated 
references to the publications of his organization for the text of the 
regulation.
    HHS response: HHS appreciates the comment and has amended the final 
rule text accordingly.

Section 37.50 Interpreting and Classifying Chest Radiographs--Film

    Procedures for classifying radiographs are unchanged from the 
existing Sec.  37.50, but for updating the requirement that images be 
interpreted and classified in accordance with the Guidelines for the 
Use of the ILO International Classification of Radiographs for 
Pneumoconioses, 2011 edition.\2\ HHS received no comments on Sec.  
37.50. HHS is changing the rule text in Sec.  37.50(a) and (c) to 
clarify that the Guidelines are being incorporated by reference.
---------------------------------------------------------------------------

    \2\ International Labour Office [2011]. Guidelines for the use 
of ILO International Classification of Pneumoconiosis, revised 
edition 2011). Geneva, Switzerland: International Labour 
Organization. Occupational Safety and Health Series No. 22 (Rev. 
2011).
---------------------------------------------------------------------------

Section 37.51 Interpreting and Classifying Chest Radiographs--Digital 
Radiography Systems

    Section 37.51 establishes requirements for the classification of 
radiographs. Of note, the ILO has recently authorized the use of the 
ILO Classification for digital images and authorized a set of standard 
digital image files for use during classification. HHS is changing the 
rule text in Sec.  37.51(b) and (c) to clarify that the Guidelines are 
being incorporated by reference.
    Comment: A commenter observes that it can be difficult for a reader 
to load the subject images on his or her picture archiving and 
communication (PACS) system, due to software issues from the system 
manufacturers. The commenter further states that that software in most 
PACS systems does not permit viewing of the miner radiograph side-by-
side with another image folder, such as the ILO standard images.
    HHS response: NIOSH is aware of this concern, and has applied 
considerable resources and effort to make available a specific software 
package (NIOSH BViewer[supreg]) which is designed to address this issue 
(the BViewer software is available for free download at http://www.cdc.gov/niosh/topics/chestradiography/digital-images.html). 
Although initially it is anticipated that some readers may have 
difficulty in displaying the standard ILO images along with the miner 
radiograph, over time, NIOSH believes that PACS manufacturers will 
incorporate software with functionality similar to B Viewer to further 
ameliorate this concern.

Section 37.52 Proficiency in the Use of Systems for Classifying the 
Pneumoconioses

    This section establishes the A and B Reader approval programs, and 
is modified from existing Sec.  37.51 to make clarifications in the 
current requirements and update older terminology. HHS received no 
comments on Sec.  37.52.

Section 37.53 Method of Obtaining Definitive Interpretations

    Section 37.53 maintains 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 will obtain a third interpretation.
    Comment: One commenter indicates that if the B Reader feels the 
image is satisfactory for identifying the abnormality, then it should 
not be disqualified if quality assurance standards have not been met. 
The commenter feels technical issues should not be used to disqualify 
evidence and therefore deny benefits if the individual is not able to 
return for repeat testing, and suggests that consensus among 2 or more 
B Readers be required where the quality of an image is in dispute.
    HHS response: A digital or screen film radiograph will not be 
disqualified for technical reasons if two or more B Readers do not find 
it unreadable and are able to classify it. The B Reader rates the 
quality of the image and classifies it for the presence and severity of 
findings associated with pneumoconiosis, but does not assess whether 
the facility making the image complied with the quality assurance 
specifications in Part 37. The rule does not constrain the reader in 
determining whether the image is either satisfactory or unreadable due 
to quality issues. Thus, responding to this comment does not 
necessitate a change to the rule text.

[[Page 56723]]

Section 37.54 Notification of Abnormal Radiographic Findings

    Section 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. As discussed 
below, Sec.  37.54(b) is amended in response to public comment.
    Comment: One commenter believes that the side-by-side review 
referenced in Sec.  37.54(b) can be confusing to the miner, and that 
all information regarding X-ray results should be communicated at one 
time. The commenter suggests that because the evaluation of findings 
other than pneumoconiosis does not require a B Reader, this section 
should permit the comparisons to be done by any licensed physician, 
and/or that the miner be provided with copies of the relevant images so 
that their personal physician can perform the comparison. Finally, the 
commenter suggests that communication about health issues be to the 
miner, and not the designated physician to reduce the chance of failure 
of important communications. Another commenter recommends that NIOSH 
utilize available in-house medical expertise to complete the ``side-by-
side'' readings. Outside consultation could still be obtained, where 
deemed useful or necessary.
    HHS response: HHS agrees with commenters that the use of a B Reader 
to interpret findings other than pneumoconiosis is unnecessary. In 
response to these comments, HHS has amended Sec.  37.54(b) to indicate 
that, instead of a B Reader, NIOSH will arrange for a licensed 
physician to compare the most recent image and interpretation to older 
ones and inform the miner of any significant changes or progression of 
disease or other comments. The rule text is also changed to clarify 
that the Department means to refer to abnormal findings other than 
pneumoconiosis and substitutes the phrase ``abnormality of cardiac 
shape or size'' for ``enlarged heart.''

Section 37.60 Submitting Required Chest Radiographs and Miner 
Identification Documents

    Section 37.60 is essentially unchanged from existing Sec.  37.60, 
which establishes the protocol for submitting radiographs. HHS received 
no comments on Sec.  37.60.

Section 37.70 Review of Interpretations

    This section is amended only to update terminology. HHS received no 
comments on Sec.  37.70.

Section 37.80 Availability of Records for Radiographs

    Section 37.80 remains unchanged from the existing requirement, 
although terminology in this section is updated. HHS received no 
comments on Sec.  37.80.

Section 37.200 Scope

    Section 37.200 remains unchanged from the existing explanation that 
provisions in this subpart establish conditions under which 
pathologists will be paid to conduct autopsies on deceased miners. HHS 
received no comments on Sec.  37.200.

Section 37.201 Definitions

    Section 37.201 retains the existing definitions for Secretary, 
miner, and pathologist, but updates ``ALFORD,'' in the existing 
provision to ``NIOSH.'' HHS received no comments on Sec.  37.201.

Section 37.202 Payment for Autopsy

    Section 37.202 retains the existing provision setting forth 
circumstances under which a pathologist may be paid by the Secretary 
for performing an autopsy. HHS received no comments on Sec.  37.202.

Section 37.203 Autopsy Specifications

    Section 37.203 retains the existing standards establishing the 
manner in which autopsies are conducted. HHS received no comments on 
Sec.  37.203.

Section 37.204 Procedure for Obtaining Payment

    Section 37.204 retains the existing procedure for submitting a 
claim for payment to NIOSH (``NIOSH'' replaces ``ALFORD'' in the rule 
text). HHS has received no comments on Sec.  37.204.

IV. Regulatory Assessment Requirements

A. Executive Order 12866 and Executive Order 13563

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). E.O. 
13563 emphasizes the importance of quantifying both costs and benefits, 
of reducing costs, of harmonizing rules, and of promoting flexibility.
    This final rule is being treated as a ``significant'' action under 
E.O. 12866. It provides for the use of digital radiography systems in 
the Coal Workers' Health Surveillance Program (CWHSP) administered by 
NIOSH under 42 CFR part 37, in cooperation with coal mine operators, to 
monitor and protect the health of U.S. coal miners, particularly for 
the prevention of coal workers' pneumoconiosis. The current regulations 
at 42 CFR part 37 only allow for the use of film-screen radiography 
systems in this program. The addition of digital X-ray standards in 
part 37 does not require mine operators to change their plans to 
accommodate digital radiographs, but it is expected to substantially 
increase the amount of access miners will have to radiograph facilities 
because the use of film-screen radiography is declining markedly 
throughout the United States and specifically in areas where coal 
mining is located and where coal miners live. In fact, many clinics 
participating in the Program have indicated that they are maintaining 
their outdated X-ray film capabilities only because of Program 
requirements, and that they intend to switch to digital radiography 
when NIOSH allows its use by promulgating this final rule. In general, 
most health care facilities have abandoned the use of film-based X-
rays. Mammography was the last mainstream radiology procedure that 
required use of film; many facilities made the final switch to digital 
several years ago when digital mammography systems became available.
    Increased access to radiograph facilities that offer digital X-rays 
is expected to result in cost savings to coal miners because they will 
not have to drive as far to visit an approved clinic.
    Digital radiographs are more 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, 
it is estimated that the cost to facilities of maintaining film X-ray 
technology to provide radiographs for approximately 2,500 coal miners 
is between $7,000 and $15,000 per clinic per year. Because NIOSH 
expects that most facilities participating in the Program will switch 
entirely to digital radiography when this rule is

[[Page 56724]]

promulgated, we estimate a first year cost savings to facilities that 
currently provide both film and digital radiographs of between $700,000 
and $1,500,000 after they have discontinued the use of film 
radiographs.
    Although this rule does not require any facility to upgrade to 
digital technology, facilities that choose to do so will necessarily 
incur costs associated with its acquisition. HHS invited public comment 
on these estimates and received one comment asserting that meeting the 
rule's quality assurance standards will be prohibitively expensive for 
small facilities. As discussed here, HHS expects that facilities 
voluntarily upgrading to digital technology will necessarily incur 
costs associated with acquiring the technology and meeting regulatory 
standards. However, the quality assurance standards in this rule 
reflect standard industry practice and should not create burdens for 
small facilities already using, or planning to use, digital chest 
imaging and wishing to join the CWHSP.
    Furthermore, the final rule does not require any radiography 
facility to perform digital radiographs for this NIOSH program. 
Facilities may continue to perform film-screen radiography under the 
current requirements of Part 37 applicable to film-screen radiography, 
which would not be substantially changed by this final rule.
    The provisions for using the DICOM standard and incorporating by 
reference standard best practices for digital radiography used in lung 
imaging ensure that the final requirements reflect standard practice 
and technology. For these reasons, the rule provisions allowing for the 
use of digital radiography and specifying equipment and practice 
parameters would not impose any additional costs on coal mine operators 
who provide for their miners' participation in this program nor on the 
radiography facilities that serve the participating coal miners.
    The final rule establishes a new requirement for coal mine 
operators to provide to NIOSH a roster of current miners under 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 
final rule is not considered economically significant, as defined in 
sec. 3(f)(1) of E.O. 12866.
    The rule is consistent with the requirements of 42 U.S.C. 7384n(c). 
The rule does not interfere with State, local, or tribal governments in 
the exercise of their governmental functions.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., 
requires each agency to consider the potential impact of its 
regulations on small entities including small businesses, small 
governmental units, and small not-for-profit organizations. This rule 
establishes standards for the delivery of digitally-acquired chest 
radiographs for underground coal miners. It does not impose any new 
requirements on small radiographic facilities that participate in the 
Coal Workers' Health Surveillance Program (CWHSP) administered by NIOSH 
under 42 CFR part 37. These facilities may continue to exclusively use 
film-screen technology for radiography under provisions that would be 
essentially unchanged by this rulemaking. The rule will benefit these 
facilities by allowing and facilitating their transition to digital 
radiography for the purposes of this program. In this respect, the 
reliance in the rule on the DICOM standards, standard technology, and 
current best practices for lung imaging radiography ensure that the 
rule is consistent with current medical practices in digital 
radiography. It should also be noted that if this standard permits some 
facilities to switch entirely to digital imaging, rather than 
maintaining two duplicate technologies, the facilities may be able to 
achieve savings in radiography operating costs, as discussed in the 
Executive Orders 12866 and 13563 analysis above. The final rule also 
introduces a substantial benefit in allowing the participation in CWHSP 
of radiography facilities that solely use digital radiography; such 
facilities currently are prohibited from participation due to the 
current lack of digital radiography standards for CWHSP under part 37.
    This final rule is expected to increase access to medical 
facilities for small and larger coal mine operators, since many medical 
facilities exclusively use digital radiography or are transitioning to 
this technology. The rule may also decrease the cost to coal mine 
operators of providing X-ray screenings to miners. Lower cost is likely 
to be one of the factors in the trend among radiography facilities to 
adopt or switch entirely to digital radiography. In any event, allowing 
and facilitating the provision of digital radiography under part 37 
will impose no new costs on small coal mine operators.
    The final rule establishes a new requirement for coal mine 
operators to provide to NIOSH a roster of current miners under Sec.  
37.4(a)(3). The provision of this roster to NIOSH is current practice 
by almost all coal mine operators. HHS estimates that, of 488 
underground coal mines that can be considered small as of the first 
quarter of 2011,\3\ 130 coal mine plans are submitted to the Agency 
annually. HHS further estimates that a clerical worker spends 0.5 hours 
per year preparing the roster. According to the Bureau of Labor 
Statistics, the average salary of a coal mine clerical worker is 
$17.38/hour; HHS estimates the annual cost for an individual coal mine 
operator to supply a roster to NIOSH is approximately $9 and the total 
cost to all coal mines combined amounts to approximately $1170 
annually. In HHS's judgment, this $9 cost would not be significant for 
any coal mine operator. Therefore, a regulatory flexibility analysis as 
provided for under the RFA is not required. HHS certifies that this 
rule will not have a significant economic impact on a substantial 
number of small entities within the meaning of the RFA.
---------------------------------------------------------------------------

    \3\ 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 June 26, 
2012.
---------------------------------------------------------------------------

C. Paperwork Reduction Act

    The Paperwork Reduction Act, 44 U.S.C. 3501 et seq., requires an 
agency to invite public comment on, and to obtain OMB approval of, any 
regulation that requires 10 or more people to report information to the 
agency or to keep certain records. This final rule continues to impose 
the same information collection requirements as under the current rule, 
including the submission of the following forms:
    [dec221] Roentgenographic Interpretation Form [CDC/NIOSH (M)2.8]
    [dec221] Miner Identification Document [CDC/NIOSH (M)2.9]
    [dec221] Coal Mine Operator's Plan [CDC/NIOSH (M)2.10]
    [dec221] Facility Certification Document [CDC/NIOSH (M)2.11]
    [dec221] Interpreting Physician Certification Document [CDC/NIOSH 
(M)2.12]
    [dec221] Consent, Release, and History Form [CDC/NIOSH (M)2.6]
    These forms are approved by OMB for data collected under the CWHSP 
(OMB Control No. 0920-0020, exp. June 30, 2014).
    The additional reporting burden associated with the Coal Mine 
Operator's Plan which requires underground coal mine operators to 
submit a roster of current employees (Sec.  37.4(a)(3)), and the 
Facility

[[Page 56725]]

Certification Document which is 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 No.     Number of    responses per     Hours/     burden (in
                                                           respondents    respondent      response       hrs)
----------------------------------------------------------------------------------------------------------------
Physicians (B Readers)............  Roentgenographic            10,000               1         3/60          500
                                     Interpretation Form--
                                     CDC/NIOSH (M) 2.8.
Miners............................  Miner Identification         5,000               1        20/60        1,667
                                     Document--CDC/NIOSH
                                     (M) 2.9.
Coal Mine Operators...............  Coal Mine Operator's           200               1        30/60          100
                                     Plan--CDC/NIOSH (M)
                                     2.10.
Super visors at X-ray Facilities..  Facility                       100               1        30/60           50
                                     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 diagnosis)...           50               1         5/60            4
Next-of-Kin.......................  Consent, Release, and           50               1        15/60           13
                                     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. For 2012, the inflation adjusted threshold is 
$139 million.

F. Executive Order 12988 (Civil Justice)

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

G. Executive Order 13132 (Federalism)

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

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

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

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

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

J. Plain Writing Act of 2010

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

V. Final Rule

List of Subjects in 42 CFR Part 37

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

Text of the Rule

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

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

0
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

0
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

[[Page 56726]]

underground coal miners and new miners.

0
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 will have the meaning given it in the Act. As 
used in this subpart:
    Act means the Federal Mine Safety and Health Act of 1977 (30 U.S.C. 
801, et seq.).
    Chest radiograph means a single posteroanterior radiographic 
projection or radiograph of the chest at full inspiration recorded on 
either film or digital radiography systems.
    Convenient time and place with respect to the conduct of any 
examination under this subpart means that the examination must be given 
at a reasonable hour in the locality in which the miner resides or a 
location that is equally accessible to the miner. For example, 
examinations at the mine during, immediately preceding, or immediately 
following work and a ``no appointment'' examination at a medical 
facility in a community easily accessible to the residences of a 
majority of the miners working at the mine, will be considered of 
equivalent convenience for purposes of this paragraph.
    Digital radiography systems, as used in this context, include both 
Digital Radiography (DR) and Computed Radiography (CR).
    (1) Computed radiography (CR) is the term for digital X-ray image 
acquisition systems that detect X-ray signals using a cassette-based 
photostimulable storage phosphor. Subsequently, the cassette is 
processed using a stimulating laser beam to convert the latent 
radiographic image to electronic signals which are then processed and 
stored so they can be displayed.
    (2) Digital radiography (DR) is the term used for digital X-ray 
image acquisition systems in which the X-ray signals received by the 
image detector are converted nearly instantaneously to electronic 
signals without movable cassettes.
    ILO Classification means the 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 
that includes a chest radiographic examination given in accordance with 
the specifications of this Part to a person not previously employed by 
the same operator. Such examinations should be conducted consistent 
with applicable law, including the Americans with Disabilities Act of 
1990, which provides that pre-placement examinations take place only 
after an offer of employment has been made and subject to certain 
restrictions (42 U.S.C. 12112(d)).
    Qualified medical physicist means an individual who is trained in 
evaluating the performance of radiographic equipment including 
radiation controls and facility quality assurance programs, and has the 
relevant current certification by a competent U.S. national board, or 
unrestricted license or approval from a U.S. State or territory.
    Radiographic technique chart means a table that specifies the types 
of cassette, intensifying screen, film or digital detector, grid, 
filter, and lists X-ray machine settings (timing, kVp, mA) that enables 
the radiographer to select the correct settings based on the body 
habitus or the thickness of the chest tissue.
    Radiologic technologist means an individual who has met the 
requirements for privileges to perform general radiographic procedures 
and for competence in using the equipment and software employed by the 
examining facility to obtain chest images as specified by the State or 
Territory and examining facility in which such services are provided. 
Optimally, such an individual will have completed a formal training 
program in radiography leading to a certificate, an associate degree, 
or a bachelor's degree and participated in the voluntary initial 
certification and annual renewal of registration for radiologic 
technologists offered by the American Registry of Radiologic 
Technologists.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of the Department of Health and Human 
Services to whom the authority involved may be delegated.
    Soft copy means the image of a coal miner's chest radiograph 
acquired using a digital radiography system, viewed at the full 
resolution of the image acquisition system using an electronic medical 
image display device.

0
4. Revise Sec.  37.3 to read as follows:

Sec.  37.3  Chest radiographs required for miners.

    (a) Voluntary examinations. Every operator must provide to each 
miner who is employed in or at any of its underground coal mines and 
who was employed in underground coal mining prior to December 30, 1969, 
or who has completed the required examinations under 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 must 
begin no sooner than October 15, 2012 and end no later than a date 
specified by NIOSH separately for each coal mine. The termination date 
of the period will be approximately 5 years from the date of the first 
examination that was made on a miner employed by the operator in its 
coal mine under the former regulations of this subpart adopted July 27, 
1973. Within the period specified by NIOSH for each mine, the operator 
may select a 6-month period within which to provide examinations in 
accordance with a plan approved under 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

[[Page 56727]]

its plan a 6-month period within which to offer its examinations to 
its miners employed at mine Y. The 6-month period must be scheduled 
between August 1, 1978 and January 1, 1979 (5 years after January 1, 
1974).

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

0
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 must 
be submitted on the Coal Mine Operator's Plan form (Form CDC/NIOSH 
(M)2.10) to NIOSH within 120 calendar days after August 1, 1978. In the 
case of a person who after August 1, 1978, becomes an operator of a 
mine for which no plan has been approved, that person must submit a 
plan within 60 days after such event occurs. A separate plan must be 
submitted by the operator and by each construction contractor for each 
underground coal mine that has a MSHA identification number. The plan 
must include:
* * * * *
    (3) The proposed beginning and ending date of the 6-month period 
for voluntary examinations (see 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 the approximate date(s) and time(s) of day during which 
the radiographs will be given to miners to enable a determination of 
whether the examinations will be conducted at a convenient time and 
place;
* * * * *
    (6) The name and address of the A or B Reader who will interpret 
and classify the chest radiographs. In the event a plan lists an 
approved facility with a digital radiography system, the name and 
address of the physician(s) who will perform the initial clinical 
interpretation.
    (7) Assurances that:
    (i) The operator will not solicit a physician's radiographic or 
other findings concerning any miner employed by the operator,
    (ii) Instructions have been given to the person(s) giving the 
examinations that duplicate radiographs or copies of radiographs 
(including, for digital radiographs, copies of electronic files) will 
not be made, and to the extent that it is technically feasible for the 
imaging system used, digital radiographs and all related digital files 
must be permanently deleted from the facility records or rendered 
permanently inaccessible following the confirmed transfer of such data 
to NIOSH, and that (except as may be necessary for the purpose of this 
subpart) the physician's radiographic and other findings, as well as 
the occupational history information obtained from a miner will not be 
disclosed in a manner that would permit identification of the 
individual with their information, and
    (iii) The radiographic examinations will be made at no charge to 
the miner.
* * * * *
    (d) The operator must advise NIOSH of any change in its plan. Each 
change in an approved plan is subject to the same review and approval 
as the originally approved plan.
    (e) The operator must promptly display in a visible location on the 
bulletin board at the mine its proposed plan or proposed change in plan 
when it is submitted to NIOSH. The proposed

[[Page 56728]]

plan or change in plan must remain posted in a visible location on the 
bulletin board until NIOSH either grants or denies approval of it at 
which time the approved plan or denial of approval must be permanently 
posted. In the case of an operator who is a construction contractor and 
who does not have a bulletin board, the construction contractor must 
otherwise notify its employees of the examination arrangements. Upon 
request, the contractor must show NIOSH written evidence that its 
employees have been notified.
    (f) Upon notification from NIOSH that sufficient time has elapsed 
since the previous period of examinations, the operator will resubmit 
its plan for each of its coal mines to NIOSH for approval for the next 
period of examinations (see Sec.  37.3(a)(2)). The plan must include 
the proposed beginning and ending dates of the next period of 
examinations and all information required by paragraph (a) of this 
section.

0
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 Sec.  203 of the Act.
    (b) Where the Secretary has reason to believe that he or she will 
deny approval of a plan the Secretary will, prior to the denial, give 
reasonable notice in writing to the operator(s) of an opportunity to 
amend the plan. The notice must specify the ground upon which approval 
is proposed to be denied.
    (c) If a plan is denied approval, the Secretary must advise the 
operator(s) in writing of the reasons for the denial.

0
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 must submit an approvable plan.

0
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) must be afforded the option of 
transferring from his or her position to another position in an area of 
the mine where the concentration of respirable dust in the mine 
atmosphere is in compliance with the MSHA requirements in 30 CFR 90.3.
* * * * *

0
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 that may result from this examination 
will be subject to the terms of Sec.  37.7.

0
10. Add Sec.  37.10 to read as follows:

Sec.  37.10  Standards incorporated by reference.

    (a) Certain material is incorporated by reference into this part 
with the approval of the Director of the Federal Register under 5 
U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that 
specified in this section, NIOSH must publish notice of change in the 
Federal Register and the material must be available to the public. All 
approved material is available for inspection at NIOSH, Division of 
Respiratory Disease Studies, 1095 Willowdale Road, Morgantown, WV 
26505. To arrange for an inspection at NIOSH, call 304-285-5749. Copies 
are also available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (b) American Association of Physicists in Medicine, Order 
Department, Medical Physics Publishing, 4513 Vernon Blvd., Madison, WI 
53705, http://www.aapm.org/pubs/reports:
    (1) AAPM On-Line Report No. 03, Assessment of Display Performance 
for Medical Imaging Systems, April 2005, into Sec.  37.51(d) and (e).
    (2) AAPM Report No. 14, Performance Specifications and Acceptance 
Testing for X-Ray Generators and Automatic Exposure Control Devices, 
Report of the Diagnostic X-Ray Imaging Committee Task Group on 
Performance Specifications and Acceptance Testing for X-Ray Generators 
and Automatic Exposure Control Devices, published by the American 
Institute of Physics for AAPM, January 1985, into Sec. Sec.  37.42(h) 
and 37.44(g).
    (3) AAPM Report No. 31, Standardized Methods for Measuring 
Diagnostic X-Ray Exposures, Report of Task Group 8, Diagnostic X-Ray 
Imaging Committee, published by the American Institute of Physics, July 
1990, into Sec.  37.44(g).
    (4) AAPM Report No. 74, Quality Control in Diagnostic Radiology, 
Report of Task Group 12, Diagnostic X-Ray Imaging Committee, published 
by Medical Physics Publishing for AAPM, July 2002, into Sec. Sec.  
37.42(h), 37.43(f), and 37.44(g).
    (5) AAPM Report No. 93, Acceptance Testing and Quality Control of 
Photostimulable Storage Phosphor Imaging Systems, October 2006, into 
Sec. Sec.  37.42(i) and 37.44(g).
    (6) AAPM Report No. 116, An Exposure Indicator for Digital 
Radiography, Report of AAPM Task Group 116, published by AAPM, July 
2009, into Sec.  37.44(g).
    (c) American College of Radiology, 1891 Preston White Dr., Reston, 
VA 20191, http://www.acr.org/~/media/ACR/Documents/PGTS/guidelines/
Reference--Levels.pdf:

[[Page 56729]]

    (1) ACR Practice Guideline for Diagnostic Reference Levels in 
Medical X-Ray Imaging, Revised 2008 (Resolution 3), into Sec. Sec.  
37.42(i) and 37.44(g).
    (2) [Reserved]
    (d) International Labour Office, CH-1211 Geneva 22, Switzerland, 
http://www.ilo.org/publns:
    (1) Guidelines for the Use of the ILO International Classification 
of Radiographs of Pneumoconioses, Revised Edition 2011, into Sec. Sec.  
37.50(a), 37.50(c), and 37.51(b).
    (2) [Reserved]
    (e) National Council on Radiation Protection and Measurements, NCRP 
Publications, 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3095, 
Telephone (800) 229-2652, http://www.ncrppublications.org:
    (1) NCRP Report No. 102, Medical X-ray, Electron Beam, and Gamma-
Ray Protection for Energies Up to 50 MeV (Equipment Design, 
Performance, and Use), issued June 30, 1989, into Sec.  37.45.
    (2) NCRP Report No. 105, Radiation Protection for Medical and 
Allied Health Personnel, issued October 30, 1989, into Sec.  37.45.
    (3) NCRP Report No. 147, Structural Shielding Design for Medical X-
Ray Imaging Facilities, revised March 18, 2005, into Sec.  37.45.
    (f) National Electrical Manufacturers Association, 1300 N. 17th 
Street, Rosslyn, VA 22209, http://medical.nema.org:
    (1) DICOM Standard PS 3.3-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 3: Information Object Definitions, 
copyright 2011, into Sec.  37.42(i).
    (2) DICOM Standard PS3.4-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 4: Service Class Specifications, 
copyright 2011, into Sec.  37.42(i).
    (3) DICOM Standard PS 3.10-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 10: Media Storage and File Format 
for Media Interchange, copyright 2011, into Sec.  37.42(i).
    (4) DICOM Standard PS 3.11-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 11: Media Storage Application 
Profiles, copyright 2011, into Sec.  37.42(i).
    (5) DICOM Standard PS 3.12-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 12: Media Formats and Physical Media 
for Media Interchange, copyright 2011, into Sec. Sec.  37.42(i) and 
37.44(a).
    (6) DICOM Standard PS 3.14-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 14: Grayscale Standard Display 
Function, copyright 2011, into Sec. Sec.  37.42(i)(5) and 37.51(d).
    (7) DICOM Standard PS 3.16-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 16: Content Mapping Resource, 
copyright 2011, Sec.  37.42(i).

0
11. 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 must be completed for each miner at the facility where 
the radiograph is made at the same time the chest radiograph required 
by this subpart is given.

0
12. Revise the undesignated center heading and Sec.  37.40 to read as 
follows:

Specifications for Performing Chest Radiographic Examinations

Sec.  37.40  General provisions.

    (a) The chest radiographic examination must be given at a 
convenient time and place.
    (b) The chest radiographic examination consists of the chest 
radiograph, and a complete Roentgenographic Interpretation Form (Form 
CDC/NIOSH (M)2.8), and Miner Identification Document (Form CDC/NIOSH 
(M)2.9).
    (c) A radiographic examination must be made in a facility approved 
in accordance with Sec.  37.43 or Sec.  37.44. Chest radiographs of 
miners under this section must be performed:
    (1) By or under the supervision of a physician who makes chest 
radiographs in the normal course of practice and who has demonstrated 
ability to make chest radiographs of a quality to best ascertain the 
presence of pneumoconiosis; or
    (2) By a radiologic technologist as defined in Sec.  37.2.

0
13. Amend Sec.  37.41 as follows:
0
a. Revise the section heading.
0
b. Redesignate paragraphs (a) and (b) as paragraphs (b) and (a) 
respectively.
0
c. Redesignate paragraphs (c) through (m) as (d) through (n).
0
d. Add new paragraph (c).
0
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 must be disrobed from the waist up at the time the 
radiograph is given. The facility must provide a dressing area and for 
those miners who wish to use one, the facility will provide a clean 
gown. Facilities must be heated to a comfortable temperature.
    (b) Every chest radiograph must be a single posteroanterior 
projection at full inspiration on a film being no less than 14 by 17 
inches and no greater than 16 by 17 inches. The film and cassette must 
be capable of being positioned both vertically and horizontally so that 
the chest radiograph will include both apices and costophrenic angles. 
If a miner is too large to permit the above requirements, then the 
projection must include both apices with minimum loss of the 
costophrenic angle.
    (c) Chest radiographs of miners under this section must be 
performed:
    (1) By or under the supervision of a physician who makes chest 
radiographs in the normal course of practice and who has demonstrated 
ability to make chest radiographs of a quality to best ascertain the 
presence of pneumoconiosis; or
    (2) By a radiologic technologist as defined in Sec.  37.2.
    (d) Radiographs must be made with a diagnostic X-ray machine with a 
maximum actual (not nominal) source (focal spot) of 2 mm, as measured 
in two orthogonal directions.
    (e) Except as provided in this paragraph (e), radiographs must be 
made with units having generators that comply with the following:
    (1) The generators of existing radiographic units acquired by the 
examining facility prior to July 27, 1973, must have a minimum rating 
of 200 mA at 100 kVp;
    (2) Generators of units acquired subsequent to that date must have 
a minimum rating of 300 mA at 125 kVp.
    (f) Radiographs made with battery-powered mobile or portable 
equipment must be made with units having a minimum rating of 100 mA at 
110 kVp at 500 Hz, or of 200 mA at 110 kVp at 60 Hz.
    (g) Capacitor discharge and field emission units may be used if the 
model of such units is approved by NIOSH for quality, performance, and 
safety. NIOSH will consider such units for approval when listed by a 
facility seeking approval under Sec. Sec.  37.43 or 37.44.
    (h) Radiographs must be given only with equipment having a beam-
limiting device that does not cause large unexposed boundaries. The 
beam limiting device must provide rectangular collimation and must be 
of the type described in 21 CFR 1020.31(d), (e), (f), and (g). The use 
of such a device must be discernible from an examination of the 
radiograph.
    (i) To ensure high quality chest radiographs:

[[Page 56730]]

    (1) The maximum exposure time must not exceed 50 milliseconds 
except that with single phase units with a rating less than 300 mA at 
125 kVp and subjects with chests over 28 cm posteroanterior, the 
exposure may be increased to not more than 100 milliseconds;
    (2) The source or focal spot to film distance must be at least 6 
feet;
    (3) Medium speed film and medium speed intensifying screens are 
recommended. However, any film-screen combination, the rated ``speed'' 
of which is at least 100 and does not exceed 300, that produces 
radiographs with spatial resolution, contrast, latitude and quantum 
mottle similar to those of systems designated as ``medium speed'' may 
be employed;
* * * * *
    (7) A suitable grid or other means of reducing scattered radiation 
must be used;
* * * * *
    (j) * * *
    (2) If mineral or other impurities in the processing water 
introduce difficulty in obtaining a high-quality radiograph, a suitable 
filter or purification system must be used.
    (k) Before the miner is advised that the examination is concluded, 
the radiograph must be processed and inspected and accepted for quality 
by the physician, or if the physician is not available, acceptance may 
be made by the radiologic technologist. In a case of a substandard 
radiograph, another must be immediately made. All substandard 
radiographs must be clearly marked as rejected and promptly sent to 
NIOSH for disposal.
* * * * *
    (m) A test object may be required on each radiograph for an 
objective evaluation of film quality at the discretion of NIOSH.
    (n)(1) Each radiograph made hereunder must be permanently and 
legibly marked with:
    (i) The name and address or NIOSH approval number of the facility 
at which it is made;
    (ii) The miner's Social Security number;
    (iii) The miner's date of birth; and
    (iv) The date of the radiograph.
    (2) No other identifying markings may be recorded on the 
radiograph.

Sec. Sec.  37.42 and 37.43  [Redesignated as Sec. Sec.  37.43 and 
37.45]

0
14a. Redesignate Sec.  37.42 and Sec.  37.43 as Sec.  37.43 and Sec.  
37.45 respectively.
0
14b. Add new Sec.  37.42 to read as follows:

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

    (a) Miners must be disrobed from the waist up at the time the 
radiograph is given. The facility must provide a private dressing area 
and for those miners who wish to use one, the facility must provide a 
clean gown. Facilities must be heated to a comfortable temperature.
    (b) Every digital chest radiograph taken as required under this 
section must be a single posteroanterior projection at full inspiration 
on a digital detector with sensor area being no less than 1505 cm 
square centimeters with a minimum width of 35cm. The imaging plate must 
have a maximum pixel pitch of 200[mu]m, with a minimum bit depth of 10. 
Spatial resolution must be at least 2.5 line pairs per millimeter. The 
storage phosphor cassette or digital image detector must be positioned 
either vertically or horizontally so that the image includes the apices 
and costophrenic angles of both right and left lungs. If the detector 
cannot include the apices and costophrenic angles of both lungs as 
described, then two side-by-side images can be obtained that together 
include the apices and the costophrenic angles of both right and left 
lungs.
    (c) Chest radiographs of miners under this section must be 
performed:
    (1) By or under the supervision of a physician who makes chest 
radiographs in the normal course of practice and who has demonstrated 
ability to make chest radiographs of a quality to best ascertain the 
presence of pneumoconiosis; or
    (2) By a radiologic technologist as defined in Sec.  37.2.
    (d) Radiographs must be made with a diagnostic X-ray machine with a 
maximum actual (not nominal) source (focal spot) of 2 mm, as measured 
in two orthogonal directions.
    (e) Radiographs must be made with units having generators which 
have a minimum rating of 300 mA at 125 kVp. Exposure kilovoltage must 
be at least the minimum as recommended by the manufacturer for chest 
radiography.
    (f) An electric power supply must be used that complies with the 
voltage, current, and regulation specified by the manufacturer of the 
machine. If the manufacturer or installer of the radiographic equipment 
recommends equipment for control of electrical power fluctuations, such 
equipment must be used as recommended.
    (g) Radiographs must be obtained only with equipment having a beam-
limiting device that does not cause large unexposed boundaries. The 
beam limiting device must provide rectangular collimation. Electronic 
post-image acquisition ``shutters'' available on some CR and DR systems 
that limit the size of the final image and that simulate collimator 
limits must not be used. The use and effect of the beam limiting device 
must be discernible on the resulting image.
    (h) Radiographic technique charts must be used that are developed 
specifically for the X-ray system and detector combinations used, 
indicating exposure parameters by anatomic measurements.
    (1) If automated exposure control devices are used, performance 
must be documented by a medical physicist utilizing the image capture 
systems and exposure parameters used at the facility for chest imaging, 
using methods recommended in AAPM Report No. 74, pages 17-18, and in 
AAPM Report No. 14, pages 61-62 (incorporated by reference, see Sec.  
37.10).
    (2) Exposure parameters achieved during the evaluation of the 
automated exposure system must be recorded by the medical physicist in 
a written report or electronic file that is stored at the facility and 
available for inspection by NIOSH for a minimum of 5 years after the 
miner's examination.
    (i) To ensure high quality digital chest radiographs:
    (1) The maximum exposure time must not exceed 50 milliseconds 
except for subjects with chests over 28 centimeters posteroanterior, 
for whom the exposure time must not exceed 100 milliseconds;
    (2) The distance from source or focal spot to detector must be at 
least 70 inches (or 180 centimeters if measured in centimeters);
    (3) The exposure setting for chest images must be within the range 
of 100-300 equivalent exposure speeds and must comply with ACR Practice 
Guideline for Diagnostic Reference Levels in Medical X-Ray Imaging, 
Section V--Diagnostic Reference Levels For Imaging With Ionizing 
Radiation and Section VII--Radiation Safety in Imaging (incorporated by 
reference, see Sec.  37.10). Radiation exposures should be periodically 
measured and patient radiation doses estimated by the medical physicist 
to assure doses are as low as reasonably achievable.
    (4) Digital radiography system performance, including resolution, 
modulation transfer function (MTF), image signal-to-noise and detective 
quantum efficiency must be evaluated and judged acceptable by a 
qualified medical physicist using the specifications in AAPM Report No. 
93, pages 1-68 (incorporated by reference, see Sec.  37.10). Image 
management software and settings for routine chest

[[Page 56731]]

imaging must be used, including routine amplification of digital 
detector signal as well as standard image post-processing functions. 
Image or edge enhancement software functions must not be employed 
unless they are integral to the digital radiography system (not 
elective); in such cases, only the minimum image enhancement permitted 
by the system may be employed.
    (5)(i) The image object, transmission and associated data storage, 
file format, and transmission of associated information must conform to 
the following components of the Digital Imaging and Communications in 
Medicine (DICOM) standard (incorporated by reference, see Sec.  37.10):
    (A) DICOM Standard PS 3.3-2011, Annex A--Composite Information 
Object Definitions, sections: Computed Radiography Image Information 
Object Definition; Digital X-Ray Image Information Object Definition; 
X-Ray Radiation Dose SR Information Object Definition; and Grayscale 
Softcopy Presentation State Information Object Definition.
    (B) DICOM Standard PS3.4-2011, Annex B--Storage Service Class; 
Annex N--Softcopy Presentation State Storage SOP Classes; Annex O--
Structured Reporting Storage SOP Classes.
    (C) DICOM Standard PS 3.10-2011.
    (D) DICOM Standard PS 3.11-2011
    (E) DICOM Standard PS 3.12-2011.
    (F) DICOM Standard PS 3.14-2011.
    (G) DICOM Standard PS 3.16-2011.
    (ii) Identification of each miner, chest image, facility, date and 
time of the examination must be encoded within the image information 
object, according to DICOM Standard PS 3.3-2011, Information Object 
Definitions, for the DICOM ``DX'' object. If data compression is 
performed, it must be lossless. Exposure parameters (kVp, mA, time, 
beam filtration, scatter reduction, radiation exposure) must be stored 
in the DX information object.
    (iii) Exposure parameters as defined in the DICOM Standard PS 3.16-
2011 must additionally be provided, when such parameters are available 
from the facility digital image acquisition system or recorded in a 
written report or electronic file and either transmitted to NIOSH or 
stored at the facility and available for inspection by NIOSH for 5 
years after the examination.
    (6) A specific test object may be required on each radiograph for 
an objective evaluation of image quality at the discretion of NIOSH.
    (7) CR imaging plates must be inspected at least once a month and 
cleaned when necessary by the method recommended by the manufacturer;
    (8) A grid or air gap for reducing scattered radiation must be 
used; grids must not be used that cause Moir[eacute] interference 
patterns in either horizontal or vertical images.
    (9) The geometry of the radiographic system must ensure that the 
central axis (ray) of the primary beam is perpendicular to the plane of 
the CR imaging plate, or DR detector and is correctly aligned to the 
grid;
    (10) Radiographs must not be made when the environmental 
temperatures and humidity in the facility are outside the 
manufacturer's recommended range of the CR and DR equipment to be used.
    (11) Before the miner is advised that the examination is concluded, 
the radiograph must be processed and inspected and accepted for quality 
by the physician, or if the physician is not available, acceptance may 
be made by the radiologic technologist. In a case of a substandard 
radiograph, another must be made immediately. Unacceptable digital 
image files must be fully deleted immediately or rendered permanently 
inaccessible in the event that permanent deletion is not 
technologically feasible.
    (j) The following are not authorized for use under this section:
    (1) Digital images derived from film screen chest radiographs 
(e.g., by scanning or digital photography); or
    (2) Images that were acquired using digital systems and then 
printed on transparencies for back-lighted display (e.g., using 
tradition view boxes).

0
15. 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 must also submit a radiograph of a 
plastic step-wedge object \1\ or other test object (available on loan 
from NIOSH) that was made and processed at the same time with the same 
technique as the radiographs submitted and processed at the facility 
for which approval is sought. At least one chest radiograph and one 
test object radiograph must have been made with each unit to be used 
hereunder. All radiographs must have been made within 15 calendar days 
prior to submission and must be marked to identify the facility where 
each radiograph was made, the X-ray machine used, and the date each was 
made. The chest radiographs will be returned and may be the same 
radiographs submitted pursuant to 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 must complete and include an X-ray Facility 
Certification Document (Form CDC/NIOSH (M) 2.11) describing each X-ray 
unit to be used to make chest radiographs under the Act. The form must 
include:
    (1) The date of the last radiation safety inspection by an 
appropriate licensing agency or, if no such agency exists, by a 
qualified expert as defined in NCRP Report No. 102 (incorporated by 
reference, see Sec.  37.10);
    (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 must have been made within 1 year 
preceding the date of application.
    (c) Radiographs submitted with applications for approval under this 
section will be evaluated by one or more individuals selected by NIOSH 
from the panel of B Readers or by a qualified medical physicist or 
consultant. Applicants will be advised of any reasons for denial of 
approval.
    (d) NIOSH or its representatives may make a physical inspection of 
the applicant's facility and any approved radiographic facility at any 
reasonable time to determine if the requirements of this subpart are 
being met.
    (e) NIOSH may require a facility periodically to resubmit 
radiographs of a test object, sample radiographs, or a Facility 
Certification Document for quality control purposes. Approvals granted 
hereunder may be suspended or withdrawn by notice in writing when in 
the opinion of NIOSH the quality of radiographs or information 
submitted under this section warrants such action. A copy of a notice 
withdrawing approval will be sent to each operator who has listed the 
facility as its facility for giving chest radiographs and must be 
displayed on the mine bulletin board adjacent to the operator's 
approved plan. The approved plan will be reevaluated by NIOSH in light 
of this change.
    (f) A formal written quality assurance program must be established 
at each facility addressing radiation exposures, equipment maintenance, 
and image

[[Page 56732]]

quality, and must conform to the standards in AAPM Report No. 74, pages 
1-19, 47-53, and 56 (incorporated by reference, see Sec.  37.10).
    (g) In conducting medical examinations pursuant to this Part, 
physicians and radiographic facilities must maintain the results and 
analysis of these examinations (including any hard copies or digital 
files containing individual data, interpretations, and images) 
consistent with applicable statutes and regulations governing the 
treatment of individually identifiable health information, including, 
as applicable, the HIPAA Privacy and Security Rules (45 CFR part 160 
and subparts A, C, and E of part 164).

0
16. 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 must demonstrate the ability to make high quality digital 
chest radiographs by submitting to NIOSH digital radiographic image 
files of a test object (e.g., a plastic step-wedge or chest phantom 
which will be provided on loan from NIOSH) as well as digital 
radiographic image files from six or more sample chest radiographs that 
are of acceptable quality to one or more individuals selected by NIOSH 
from the panel of B Readers and a qualified medical physicist or 
consultant, both designated by NIOSH. Image files must be submitted on 
standard portable media (compact or digital video disc) and formatted 
to meet specifications of the Digital Imaging and Communications in 
Medicine (DICOM) standard PS 3.12-2011 (incorporated by reference, see 
Sec.  37.10). Applicants will be advised of any reasons for denial of 
approval. All submitted images must be made within 60 days prior to the 
date of application using the same technique, equipment, and software 
as will be used by the facility under the requested approval. At least 
six chest radiographs and one test object radiograph must have been 
made with each digital radiographic unit to be used by the facility 
under the requested approval. The corresponding radiographic image 
files must be submitted on standard portable media (compact or digital 
video disc) and formatted to meet specifications of the current DICOM 
Standard PS 3.12-2011. Documentation must include the following: the 
identity of the facility where each radiograph was made; the X-ray 
machine used; and the model, version, and production date of each image 
acquisition software program and hardware component. The submitted 
sample digital chest image files must include at least two taken with 
the detector in the vertical position and two in the horizontal 
position where the imaging system permits these positions, and at least 
two chest images must be from persons within the highest quartile of 
chest diameters (28 cm or greater).
    (2) Each radiographic facility submitting chest radiographic image 
files for approval under this section must complete and include an X-
ray Facility Certification Document (Form CDC/NIOSH (M)2.11) describing 
each 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 must include:
    (i) A copy of a dated report signed by a qualified medical 
physicist, documenting the evaluation of radiation safety and 
performance characteristics specified in this section for each digital 
radiography system;
    (ii) A copy of the report of the most recent radiation safety 
inspection by a licensing agency, if such agency exists;
    (iii) A listing of all deficiencies noted in either of the reports;
    (iv) A statement that all the listed deficiencies have been 
corrected; and
    (v) The names and relevant training and experience of facility 
personnel described in paragraphs (b), (d), and (e) of this section. To 
be acceptable, the report by the medical physicist and radiation safety 
inspection specified in this paragraph must have been made within 1 
year prior to the date of submission of the application.
    (b) Facilities must maintain ongoing licensure and certification 
under relevant local, State, and Federal laws and regulations for all 
digital equipment and related processes covered under this part.
    (c) NIOSH or its representatives may make a physical inspection of 
the applicant's facility and any approved radiographic facility at any 
reasonable time to determine if the requirements of this subpart are 
being met.
    (d) NIOSH may periodically require a facility to resubmit 
radiographic image files of the NIOSH-supplied test object (e.g., step-
wedge or chest phantom), sample radiographs, or a Facility 
Certification Document. Approvals granted to facilities under this 
section may be suspended or withdrawn by notice in writing when, in the 
opinion of NIOSH, deficiencies in the quality of radiographs or 
information submitted under this section warrant such action. A copy of 
a notice suspending or withdrawing approval will be sent to each 
operator that has listed the facility for its use under this Part and 
must be displayed on the mine bulletin board adjacent to the operator's 
approved plan. The operator's approved plan may be reevaluated by NIOSH 
in response to such suspension or withdrawal.
    (e) A qualified medical physicist who is familiar with the facility 
hardware and software systems for image acquisition, manipulation, 
display, and storage, must be on site or available as a consultant. The 
physicist must be trained in evaluating the performance of radiographic 
equipment and facility quality assurance programs, and must be 
licensed/approved by a State or Territory of the United States or 
certified by a competent U.S. national board.
    (f) Facilities must document that testing performed by a qualified 
medical physicist has verified that performance of each image 
acquisition system for which approval is sought met initial 
specifications and standards of the equipment manufacturer and 
performance testing as required under paragraphs (b), (e), and (g) of 
this section.
    (g) A formal written quality assurance program must be established 
at each facility addressing radiation exposures, equipment maintenance, 
and image quality, and must conform to the standards in AAPM Report No. 
74, pages 1-19, 47-53, and 56, and AAPM Report No. 116, sections VIII, 
IX, and X (incorporated by reference, see Sec.  37.10).
    (1) Applications for facility approval must include a comprehensive 
assessment by a qualified medical physicist within 12 months prior to 
application addressing the performance of X-ray generators, automatic 
exposure controls, and image capture systems. The assessment must 
comply with the following guidelines: AAPM Report No. 93, pages 1-68; 
AAPM Report No. 74, pages 6-11; and AAPM Report No. 14, pages 1-96 
(incorporated by reference, see Sec.  37.10).
    (2) Radiographic technique charts must be used that are developed 
specifically for the X-ray system and detector combinations used, 
indicating exposure parameters by anatomic measurements. If automated 
exposure control devices are used, calibration for chest imaging must 
be documented using the actual voltages and image capture systems. 
Radiological exposures resulting from at least ten (randomly selected) 
digital chest images obtained at the facility must be monitored at 
least quarterly to detect and correct potential dose creep, using 
methods specified in AAPM Report No. 31 (incorporated by reference, see 
Sec.  37.10). Radiation exposures must be compared to a professionally 
accepted reference level

[[Page 56733]]

published in the American College of Radiology (ACR) Practice Guideline 
for Diagnostic Reference Levels in Medical X-Ray Imaging, pages 1-6 
(incorporated by reference, see Sec.  37.10). In addition, the medical 
physicist must submit an annual assessment of measured or estimated 
radiation exposures, with specific recommended actions to minimize 
exposures during examinations performed under this part.
    (3) For each digital radiography device and system, performance 
must be monitored annually in accordance with the recommendations of 
AAPM Report No. 93 (incorporated by reference, see Sec.  37.10), except 
for the testing specifically excluded below. Documentation must be 
maintained on the completion of quality assurance testing, including 
the reproducibility of X-ray output, linearity and reproducibility of 
mA settings, accuracy and reproducibility of timer and kVp settings, 
accuracy of source-to-detector distance, and X-ray field focal spot 
size, selection, beam quality, congruence and collimation. For DR 
systems, the following tests listed in AAPM Report No. 93 are not 
required under this part:

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

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

0
17. 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, must conform to applicable 
State or Territorial and Federal regulations. Where no applicable 
regulations exist, radiographic equipment, its use and the facilities 
(including mobile facilities) in which such equipment is used must 
conform to the recommendations in NCRP Report No. 102, NCRP Report No. 
105, and NCRP Report No. 147 (incorporated by reference, see Sec.  
37.10).

0
18. 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 must be interpreted and classified in 
accordance with the Guidelines for the Use of the ILO International 
Classification of Radiographs of Pneumoconioses (incorporated by 
reference, see Sec.  37.10). Chest radiograph interpretations and 
classifications must be recorded on a paper or electronic 
Roentgenographic Interpretation Form (Form CDC/NIOSH (M)2.8).
    (b) Radiographs must be interpreted and classified only by a 
physician who reads chest radiographs in the normal course of practice 
and who has demonstrated proficiency in classifying the pneumoconioses 
in accordance with Sec.  37.52.
    (1) Initial clinical interpretations and notification of findings 
other than pneumoconiosis under Sec.  37.50(a) must be provided by a 
qualified physician who has all required licensure and privileges, and 
interprets chest radiographs in the normal course of practice.
    (2) [Reserved]
    (c) All interpreters, whenever interpreting chest radiographs made 
under the Act, must have immediately available for reference a complete 
set of the standard radiographs for use with the Guidelines for the Use 
of the ILO International Classification of Radiographs of 
Pneumoconioses (incorporated by reference, see Sec.  37.10).
    (d) In all view boxes used for making interpretations:
    (1) Fluorescent lamps must be simultaneously replaced with new 
lamps at 6-month intervals;
    (2) All the fluorescent lamps in a panel of boxes must have 
identical manufacturer's ratings as to intensity and color;
    (3) The glass, internal reflective surfaces, and the lamps must be 
kept clean;
    (4) The unit must be so situated as to minimize front surface 
glare.

Sec. Sec.  37.51 through 37.53   [Redesignated as Sec. Sec.  37.52 
through 37.54]

0
19a. Redesignate Sec.  37.51 through Sec.  37.53 as Sec.  37.52 through 
Sec.  37.54 respectively.
0
19b. 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 must 
provide an initial clinical interpretation and notification, as 
specified in Sec.  37.54, of any significant abnormal findings other 
than pneumoconiosis.
    (b) Chest radiographs must be classified for pneumoconiosis by 
physician readers who have demonstrated ongoing proficiency, as 
specified in Sec.  37.52(b), in classifying the pneumoconioses in a 
manner consistent with the Guidelines for the Use of the ILO 
International Classification of Radiographs of Pneumoconioses 
(incorporated by reference, see Sec.  37.10). Chest radiograph 
interpretations and classifications must be recorded on a paper or 
electronic Roentgenographic Interpretation Form (Form CDC/NIOSH 
(M)2.8).
    (c) All interpreters, whenever classifying digitally-acquired chest 
radiographs made under the Act, must have immediately available for 
reference a complete set of NIOSH-approved standard digital chest 
radiographic images provided for use with the Guidelines for the Use of 
the ILO International Classification of Radiographs of Pneumoconioses 
(incorporated by reference, see Sec.  37.10). Only NIOSH-approved 
standard digital images may be used for classifying digital chest 
images for pneumoconiosis. Modification of the appearance of the 
standard images using software tools is not permitted.
    (d) Viewing systems should enable readers to display the coal 
miner's chest image at the full resolution of the image acquisition 
system, side-by-side with the selected NIOSH-approved standard images 
for comparison.
    (1)(i) Image display devices must be flat panel monitors displaying 
at least 3 MP at 10 bit depth. Image displays and associated graphics 
cards must meet the calibration and other specifications of the Digital 
Imaging and Communications in Medicine (DICOM)

[[Page 56734]]

standard PS 3.14-2011 (incorporated by reference, see Sec.  37.10).
    (ii) Image displays and associated graphics cards must not deviate 
by more than 10 percent from the grayscale standard display function 
(GSDF) when assessed according to the AAPM On-Line Report No. 03, pages 
1-146 (incorporated by reference, see Sec.  37.10).
    (2) Display system luminance (maximum and ratio), relative noise, 
linearity, modulation transfer function (MTF), frequency, and glare 
should meet or exceed recommendations listed in AAPM On-Line Report No. 
03, pages 1-146 (incorporated by reference, see Sec.  37.10). Viewing 
displays must 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, must 
be included in luminance measurements.
    (3) Displays must be situated so as to minimize front surface 
glare. Readers must minimize reflected light from ambient sources 
during the performance of classifications.
    (4) Measurements of the width and length of pleural shadows and the 
diameter of opacities must be taken using calibrated software measuring 
tools. If permitted by the viewing software, a record must be made of 
the presentation state(s), including any noise reduction and edge 
enhancement or restoration functions that were used in performing the 
classification, including any annotations and measurements.
    (e) Quality control procedures for devices used to display chest 
images for classification must comply with the recommendations of the 
American Association of Physicists in Medicine AAPM On-Line Report No. 
03, pages 1-146 (incorporated by reference, see Sec.  37.10).
    (1) If automatic quality assurance systems are used, visual 
inspection must be performed using one or more test patterns 
recommended by the medical physicist every 6 months, or more 
frequently, to check for defects that automatic systems may not detect.
    (2) [Reserved]
    (f) Classification of CR and DR digitally-acquired chest 
radiographs under this Part must be performed based on the viewing of 
images displayed as soft copies using the viewing workstations 
specified in this section. Classification of radiographs must not be 
based on the viewing of hard copy printed transparencies of images that 
were digitally-acquired.
    (g) The classification of chest radiographs based on digitized 
copies of chest radiographs that were originally acquired using film-
screen techniques is not permissible under this part.

0
20. 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 must continue if established prior to 
October 15, 2012.
    (2) Physicians who desire to be A Readers must demonstrate their 
proficiency in classifying the pneumoconioses by either:
    (i) Submitting to NIOSH from the physician's files six sample chest 
radiographs which are considered properly classified by one or more 
individuals selected by NIOSH from the panel of B Readers. The six 
radiographs must consist of two without pneumoconiosis, two with simple 
pneumoconiosis, and two with complicated pneumoconiosis (these may be 
the same radiographs submitted for facility approval pursuant to Sec.  
37.43 and Sec.  37.44). The films will be returned to the physician. 
The interpretations must be on the Roentgenographic Interpretation Form 
(Form CDC/NIOSH (M)2.8), or;
    (ii) Satisfactory completion, since June 11, 1970, of a course 
approved by NIOSH on the ILO International Classification of 
Radiographs of Pneumoconioses.
    (b) Final or B Readers:
    (1) Approval as a B Reader established prior to October 1, 1976, is 
hereby terminated.
    (2) Proficiency in evaluating chest radiographs for radiographic 
quality and in the use of the ILO Classification for interpreting chest 
radiographs for pneumoconiosis and other diseases must be demonstrated 
by those physicians who desire to be B Readers by taking and passing a 
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 must 
familiarize themselves with the necessary components for attainment of 
reliable classification of chest radiographs for the pneumoconioses \2\ 
and apply using an Interpreting Physician Certification Document (Form 
CDC/NIOSH (M)2.12).
---------------------------------------------------------------------------

    \2\ NIOSH Safety and Health Topic. Chest Radiography: 
Radiographic Classification [http://www.cdc.gov/niosh/topics/chestradiography/radiographic-classification.html]. Date accessed: 
June 27, 2012.

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

0
22. Revise newly designated Sec.  37.54 to read as follows:

Sec.  37.54  Notification of abnormal radiographic findings.

    (a) Findings of, or findings suggesting, abnormality of cardiac 
shape or size, tuberculosis, lung cancer, or any other significant 
abnormal findings other than pneumoconiosis must be communicated by the 
first physician to interpret the radiograph to the miner indicated on 
the Miner Identification Document or to the miner's designated 
physician. A notice

[[Page 56735]]

of the communication must be submitted to NIOSH. When significant 
abnormal findings are reported, NIOSH will also notify the miner to 
contact his or her physician.
    (b) In addition, when NIOSH has more than one radiograph of a miner 
in its files and the most recent examination was found by the first 
physician to interpret the radiograph or subsequently by NIOSH B 
Readers to show an abnormality of cardiac shape or size, tuberculosis, 
cancer, complicated pneumoconiosis, and any other significant abnormal 
findings, NIOSH will arrange for a licensed physician to compare the 
most recent image and interpretation to older images and NIOSH will 
inform the miner of any significant changes or progression of disease 
or other findings.
    (c) All final findings regarding pneumoconiosis will be sent to the 
miner by MSHA in accordance with section 203 of the Act (see 30 CFR 
part 90). Positive findings with regard to pneumoconiosis will be 
reported to the miner or to the miner's designated physician by NIOSH.
    (d) NIOSH will make every reasonable effort to process the findings 
described in paragraph (c) of this section within 60 days of receipt of 
the information described in 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 
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.

0
23. 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, must be submitted together 
for each miner to NIOSH within 14 calendar days after the radiographic 
examination is given and become the property of NIOSH.
    (1) When the radiograph is digital, the image file for each 
radiograph, together with either hard copy or electronic versions of 
the completed Roentgenographic Interpretation Form and the completed 
Miner Identification Document, must be submitted to NIOSH using the 
software and format specified by NIOSH either using portable electronic 
media, or a secure electronic file transfer within 14 calendar days 
after the radiographic examination. NIOSH will notify the submitting 
facility when it has received the image files and forms from the 
examination. After this notification, the facility will permanently 
delete, or if this is not technologically feasible for the imaging 
system used, render permanently inaccessible all files and forms from 
its electronic and physical files.
    (2) [Reserved]
    (b) If NIOSH deems any submission under paragraph (a) of this 
section inadequate, it will notify the operator of the deficiency. The 
operator must promptly make appropriate arrangements for the necessary 
reexamination.
    (c) Failure to comply with paragraph (a) or (b) of this section 
will be cause to revoke approval of a plan or any other approval as may 
be appropriate. An approval that has been revoked may be reinstated at 
the discretion of NIOSH after it receives satisfactory assurances and 
evidence that all deficiencies have been corrected and that effective 
controls have been instituted to prevent a recurrence.
    (d) Chest radiographs and other required documents must be 
submitted only for miners.
* * * * *
0
24. 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 must 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 must be so informed by MSHA.
    (b) Any operator who is directed by MSHA to transfer a miner to a 
less dusty atmosphere based on the most recent examination made 
subsequent to August 1, 1978, may file a written request with NIOSH to 
review its findings. The standards set forth in paragraph (a) of this 
section apply and the operator and miner will be notified by MSHA 
whether the miner is entitled to the option to transfer.

0
25. 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.

0
26. 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.

0
27. 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.

0
28. 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 must be submitted to 
NIOSH and must include:
* * * * *
    (b) Completed PHS Consent, Release and History form (Form CDC/NIOSH 
(M)2.6). This form may be completed with the assistance of the 
pathologist, attending physician, family physician, or any other 
responsible person who can provide reliable information.
* * * * *

    Dated: August 28, 2012.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2012-22253 Filed 9-12-12; 8:45 am]
BILLING CODE 4150-18-P
```