[Federal Register Volume 77, Number 5 (Monday, January 9, 2012)]
[Proposed Rules]
[Pages 1360-1385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-33164]
[[Page 1359]]
Vol. 77
Monday,
No. 5
January 9, 2012
Part VI
Department of Health and Human Services
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42 CFR Part 37
Specifications for Medical Examinations of Underground Coal Miners;
Proposed Rule
Federal Register / Vol. 77 , No. 5 / Monday, January 9, 2012 /
Proposed Rules
[[Page 1360]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 37
[Docket No. CDC-2011-0013; NIOSH-225]
RIN 0920-AA21
Specifications for Medical Examinations of Underground Coal
Miners
AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Notice of proposed rulemaking.
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SUMMARY: With this notice of proposed rulemaking, the Department of
Health and Human Services (HHS) proposes to modify its regulations on
Specifications for Medical Examinations of Underground Coal Miners.
Existing regulations establish specifications for providing,
interpreting, classifying, and submitting film-based roentgenograms
(now commonly called chest radiographs or X-rays) of underground coal
miners for the surveillance of coal workers' pneumoconiosis (black
lung) under the Coal Workers' Health Surveillance Program, administered
by the National Institute for Occupational Safety and Health (NIOSH).
The current standards specify requirements that permit the use of film-
based radiography systems only; proposed amendments would retain those
standards (with minor modifications that reflect more commonly-used
terms) and add a parallel set of standards to specify requirements that
would permit the use of digital radiography systems. An additional
proposed amendment would require coal mine operators to provide NIOSH
with employee rosters to assist the Program in improving participation
by miners.
DATES: Comments must be received by March 9, 2012.
ADDRESSES: You may submit comments, identified by ``RIN 0920-AA21,'' by
any of the following methods:
Internet: Access the Federal e-rulemaking portal at http://www.regulations.gov. Follow the instructions for submitting comments.
Email: NIOSH Docket Officer, [email protected]. Include
``RIN 0920-AA21'' and ``42 CFR 37'' in the subject line of the message.
Mail: NIOSH Docket Office, Robert A. Taft Laboratories,
MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
Instructions: All submissions received must include the agency name
and docket number or Regulation Identifier Number (RIN) for this
rulemaking. All relevant comments will be posted without change to
http://www.regulations.gov including any personal information provided.
For detailed instructions on submitting comments and additional
information on the rulemaking process, see the ``Public Participation''
heading of the SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or http://www.cdc.gov/niosh/docket/NIOSHdocket0225.html.
FOR FURTHER INFORMATION CONTACT: Anita Wolfe, Public Health Analyst,
Division of Respiratory Disease Studies, National Institute for
Occupational Safety and Health, 1095 Willowdale Road, MS B208,
Morgantown, WV, 26505, Telephone (888) 480-4042 (this is a toll-free
number). Information requests can also be submitted by email to
[email protected].
SUPPLEMENTARY INFORMATION: The preamble to this notice of proposed
rulemaking is organized as follows:
Table of Contents
I. Public Participation
II. Background
A. Need for Rulemaking
B. Scope of Rulemaking
C. Impact of Rulemaking
III. Summary of Proposed Rule
A. Subpart--Chest Radiographic Examinations
B. Subpart--Autopsies
IV. Regulatory Assessment Requirements
A. Executive Order 12866
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
D. Small Business Regulatory Enforcement Fairness Act
E. Unfunded Mandates Reform Act of 1995
F. Executive Order 12988 (Civil Justice)
G. Executive Order 13132 (Federalism)
H. Executive Order 13045 (Protection of Children From
Environmental Health Risks and Safety Risks)
I. Executive Order 13211 (Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use)
J. Plain Writing Act of 2010
V. Proposed Rule
I. Public Participation
Interested persons or organizations are invited to participate in
this rulemaking by submitting written views, arguments,
recommendations, and data. Comments are invited on any topic related to
this proposal. In addition, HHS invites comments specifically on the
following questions related to this rulemaking:
(1) Does the current scientific evidence support the assertion that
the application of digital chest imaging can be equivalent to film-
screen radiography, if appropriate equipment, procedures, and methods
are applied, in meeting the objectives of the Coal Workers' Health
Surveillance Program mandated by 30 U.S.C. 843?
(2) Is there evidence that the proposed specifications for
equipment, personnel, procedures, and methods will not be adequate to
assure that the application of digital chest imaging will be equivalent
to film-screen radiography in meeting the objectives of the Coal
Workers' Health Surveillance Program? What specific changes are needed
to ensure equivalence and what is the evidence supporting those
changes?
(3) Is there evidence that any element of the specifications will
not be feasible (for technological or financial reasons) for a
significant proportion of the digital radiology facilities in coal
mining regions? If yes, what changes in the specifications for
equipment, personnel, procedures, and/or methods can improve
feasibility while continuing to ensure the equivalence of digital chest
imaging to film-based chest imaging for accurately detecting occurrence
and progression of coal workers' pneumoconiosis (CWP) among coal
miners?
II. Background
All mining work generates fine particles of dust in the air. Coal
miners who inhale excessive dust are known to develop a group of
diseases of the lungs and airways, including chronic bronchitis,
emphysema, chronic obstructive pulmonary disease, silicosis, and
CWP.\1\ To address such threats to the U.S. coal mining workforce, the
Coal Mine Health and Safety Act was enacted in 1969 (Pub. L. 91-173)
and amended by the Federal Mine Safety and Health Act of 1977 (Pub. L.
95-164, 30 U.S.C. 801 et seq.) (Mine Act). The statutes included an
enforceable 2 milligrams per cubic meter limit on respirable dust
exposure during underground coal mine work (30 U.S.C. 842(b)(2)).\2\
The science available at that time indicated that enforcement of this
limit would greatly reduce the development of CWP, but could not ensure
that all miners would be protected from developing disabling or lethal
disease.
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\1\ Petsonk EL, Parker JE [2008]. Coal workers' lung diseases
and silicosis. In: Fishman AP, Elias J, Fishman J, Grippi M, Senior
R, Pack A eds. Fishman's Pulmonary Diseases and Disorders. 4th ed.
New York: McGraw-Hill, pp. 967-980.
\2\ The Mine Safety and Health Administration (MSHA) has
recently published a notice of proposed rulemaking that seeks to
lower the existing exposure limit from 2.0 mg/m\3\ to 1.0 mg/m\3\
(75 FR 64412, October 19, 2010).
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The NIOSH Coal Workers' Health Surveillance Program (CWHSP), also
[[Page 1361]]
mandated by the Mine Act, was developed to detect CWP and prevent
progression in individual miners, while at the same time providing
information for evaluation of temporal and geographic trends in
pneumoconiosis. The Mine Act grants NIOSH general authority to issue
regulations as the Institute deems appropriate in carrying out
provisions of the Act and specifically directs that medical
examinations for underground coal miners shall be given in accordance
with specifications prescribed by NIOSH (30 U.S.C. 843(a), 957).
To inform each miner of his or her health status, the Act requires
that underground coal mine operators offer new workers a chest
roentgenogram (hereafter chest radiograph or X-ray) through an approved
facility as soon as possible after employment starts. Three years later
a miner must be offered a second chest radiograph. If this second
examination reveals evidence of pneumoconiosis, the miner is entitled
to a third chest radiograph 2 years after the second. Further, all
miners working in an underground coal mine must be offered a chest
radiograph approximately every 5 years. All chest radiographs are to be
given in accordance with specifications prescribed by the Secretary of
Health and Human Services (30 U.S.C. 843(a)).
Chest radiographs taken for the CWHSP are assessed by qualified and
licensed physician A or B Readers. A Readers are physicians who
interpret chest radiographs for clinical purposes. They will have
demonstrated knowledge of the International Labour Office (ILO)
Classification of Radiographs of Pneumoconioses by completing a NIOSH-
approved course or submitting six radiographs with satisfactory
classifications, as specified in 42 CFR 37.51.
B Readers are physicians who have demonstrated proficiency in the
use of the ILO classification system by taking and passing a specially-
designed proficiency examination offered by NIOSH, as specified in 42
CFR 37.51. The NIOSH B Reader Program aims to ensure competency in the
detection of pneumoconiosis by evaluating the ability of readers to
classify a test set of radiographs, thereby creating and maintaining a
pool of qualified readers having the skills and ability to provide
accurate and precise classifications in accordance with ILO
standards.\3\ The B Reader examination currently offered by NIOSH
consists of the classification of 125 chest radiographs over the course
of 6 hours; the test addresses proficiency in classification of small
opacities, large opacities, pleural abnormalities, and certain other
abnormalities that may appear in the lung radiographs.
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\3\ International Labour Office [2011]. Guidelines for the use
of ILO International Classification of Pneumoconiosis, revised
edition 2011. Geneva, Switzerland: International Labour Office.
Occupational Safety and Health Series No. 22 (Rev. 2011).
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B Readers participate in national pneumoconiosis programs directed
at coal miners and others who suffer from dust-related illness, and are
also involved with epidemiologic evaluations, surveillance, and worker
monitoring programs involving many types of pneumoconioses. In applying
the ILO Classification, B Readers compare sets of standard images,
which represent different types of abnormalities and levels of disease
severity, with images of the individual being evaluated to identify
parenchymal abnormalities (small and large opacities), pleural changes,
and other features associated, or sometimes confused, with occupational
lung disease. In the current ILO Classification, the B Reader is first
asked to grade film quality and is then asked to categorize small
opacities according to their presence, shape and size, location, and
profusion. Large opacities are classified according to their presence
and size. The B Reader also assesses the presence, location, width,
extent, and degree of calcification of pleural abnormalities.\4\
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\4\ NIOSH [2007]. Roentgenographic Interpretation Form [http://www.cdc.gov/niosh/topics/surveillance/ords/pdfs/CWHSP-ReadingForm-2.8.pdf]. Date accessed: January 5, 2011.
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Under NIOSH supervision (see 42 CFR 37.53, as amended, below), a
summary report based upon the readings of the periodic chest radiograph
is sent to each participating coal miner, who then has the opportunity
to take action to reduce further dust exposure if early dust-induced
lung disease is detected. Miners with evidence of pneumoconiosis have
specific rights to transfer to jobs with lower dust levels under 30 CFR
part 90 (see also 42 CFR 37.7). The combined results of these
radiographic examinations of miners (radiographic surveillance) also
enable NIOSH to track rates and patterns of CWP among the participating
miners, so as to evaluate whether the implemented dust controls are
effective in controlling CWP.
A. Need for Rulemaking
One goal of the Mine Act is to ensure that respirable dust
concentrations in underground coal mines are sufficiently low to permit
each miner the opportunity to be employed underground for a working
lifetime without incurring any disability from pneumoconiosis or any
other occupational lung disease (30 U.S.C. 841(b)). Mine operators use
primary prevention to accomplish this health outcome objective; that
is, they implement procedures for recognizing, controlling, and
monitoring exposures to hazardous conditions.
However, because primary prevention measures may not be fully
effective, secondary measures are recommended as a means to further
protect workers. Secondary prevention involves ongoing miner health
monitoring to recognize abnormalities early so that the miner has the
necessary information to take appropriate action to prevent disease
progression. Monitoring data are also periodically reviewed and
analyzed to evaluate whether the primary preventive measures have been
effective. This review permits the identification of work processes,
exposures, or hazardous situations that require better control.
Secondary prevention is particularly important when a risk to health
remains in spite of adherence to recommended or permissible exposure
levels, as has been demonstrated for coal miners.\5\
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\5\ NIOSH [1995]. Criteria for a recommended standard:
Occupational exposure to respirable coal mine dust. Cincinnati,
Ohio: U.S. Department of Health and Human Services, Centers for
Disease Control and Prevention, National Institute for Occupational
Safety and Health, DHHS (NIOSH) Publication No. 95-106.
See also NIOSH [2010]. A review of information published since
1995 on coal mine dust exposures and associated health outcomes.
NIOSH Docket Number 210 [http://www.cdc.gov/niosh/docket/review/docket210/]. Date accessed: January 5, 2011.
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Chest radiography has historically been a valuable tool for
monitoring the health of coal miners and other individuals potentially
exposed to fibrogenic dusts such as silica or asbestos. Early changes
due to pneumoconiosis are frequently identifiable on a high quality
chest radiograph before an individual would otherwise seek medical
attention. Over the years, methods for acquiring and interpreting film-
screen chest radiographs have been continuously refined, to enhance the
accuracy and usefulness of this technique as part of comprehensive
occupational health protection programs. However, over the past decade
digital radiography systems have been progressively replacing
traditional analog film-based radiography for chest imaging.\6\
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\6\ NIOSH [2008]. Application of the ILO International
Classification of Radiographs of Pneumoconioses to Digital Chest
Radiographic Images: A NIOSH Scientific Workshop. Cincinnati, OH:
U.S. Department of Health and Human Services, Public Health Service,
Centers for Disease Control and Prevention, National Institute for
Occupational Safety and Health. DHHS (NIOSH) Publication No. 2008-
139.
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[[Page 1362]]
In order to retain the recognized benefits of radiographic health
monitoring as a preventive health measure that is easily accessible by
dust-exposed workers, it is necessary to require that underground coal
mine operators furnish NIOSH with a current roster of miners' names and
addresses. CWHSP has found that directly contacting coal miners who are
due for a chest examination results in a higher number of miners who
participate in the Program. In 1990, NIOSH responded to declining
underground coal miner participation in the Program by obtaining work
rosters for contact information and sending notifications of
availability of chest X-ray surveillance directly to the miners. Over
the next few years, this led to increased participation in the
Program.\7\ Coal miners themselves have indicated that they would
prefer to receive a letter from CWHSP at their residence, rather than
being notified by their employer, because they feel that direct contact
with the Program provides them greater confidentiality. Also, in the
experience of CWHSP, the increased family involvement that follows from
receipt of a letter at home improves Program participation. Almost all
underground coal mine operators (approximately 505 establishments \8\)
provide CWHSP with a roster of employees. The rare instance of an
operator refusing to comply with the request resulted in no coal miners
employed by a non-compliant operator participating in the Program.
NIOSH is concerned that further noncompliance with CWHSP's request will
lead to lower rates of participation in the Program, and result in
higher rates of pneumoconiosis. An alternative to the roster
requirement--asking the mines to post Program information on a bulletin
board in the mine--has been found to be ineffective and has not
resulted in the same level of participation that has been demonstrated
by direct mailings.
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\7\ See Work-Related Lung Disease (WoRLD) Surveillance System,
Volume 1: Coal Workers' Pneumoconiosis: Morbidity, Table 2012.
CWXSP: Number and percentage of examined underground miners with
coal workers' pneumoconiosis (ILO category 1/0+) by tenure, 1970-
2009, http://www2a.cdc.gov/drds/WorldReportData/FigureTableDetails.asp?FigureTableID=2550&GroupRefNumber=T02-12.
Accessed November 17, 2011.
\8\ U.S. Department of Labor, Mine Safety and Health
Administration. Mining Industry Accident, Injuries, Employment, and
Production Data--Address & Employment Self-Extracting Files. http://www.msha.gov/stats/part50/p50y2k/aetable.htm. Accessed July 7,
2011.
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Finally, previously effective approaches to radiographic monitoring
need to be modified to reflect the different characteristics of digital
imaging compared to film-screen radiography. Additionally, due to the
broad diversity of hardware and software utilized in digital imaging,
specifications are required to assure that the operational
characteristics of the image acquisition and display systems are
sufficiently standardized to support uniformity among these health
assessments. In addition, they must assure confidentiality to the
extent permitted by law, data integrity, and interoperability.\9\ Most
importantly, they must permit accurate identification of the early
changes seen in dust-related diseases.
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\9\ Samei E, Ravin CE [2008]. Assuring image quality for
classification of digital chest radiographs. In: NIOSH. Application
of the ILO International Classification of Radiographs of
Pneumoconioses to Digital Chest Radiographic Images: A NIOSH
Scientific Workshop. Cincinnati, OH: U.S. Department of Health and
Human Services, Public Health Service, Centers for Disease Control
and Prevention, National Institute for Occupational Safety and
Health. DHHS (NIOSH) Publication No. 2008-139.
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B. Scope of Rulemaking
Existing regulations under 42 CFR part 37 provide rules and
specifications for giving, interpreting, classifying, and submitting
chest radiographs as required under section 203 of the Federal Mine
Safety and Health Act of 1977, as amended (30 U.S.C. 843). Those rules
will essentially remain in effect: This rulemaking will not
substantially alter the current standards, but will update the
terminology used in the current standards (e.g., ``roentgenogram'' to
``radiograph'') and include edits to maintain the accuracy of external
references.
Significantly, the new rule would expand the availability of chest
radiographic examinations by establishing additional options for
giving, interpreting, classifying, and submitting digitally-acquired
radiographs under the same scope as the existing rule does for film
radiographs. The proposed rule would establish the minimum
specifications for methods, procedures, quality assurance,
documentation, and equipment including computer software for facilities
seeking approval to perform and submit digital radiographic
examinations as well as the physician readers who interpret, classify,
and submit reports using those radiographs. The proposed rule would
also make limited changes to general requirements to reflect current
terminology (such as the use of ``radiograph'' instead of
``roentgenogram'' which is no longer commonly used), practice or needs,
such as requiring mine operators to provide a roster of current miners
to NIOSH, which uses this information to promote miner participation in
the Coal Workers' Health Surveillance Program. The proposed rule will
not modify existing requirements for miner radiographic examinations,
eligibility, or other rights, including transfer of affected miners in
accordance with 30 CFR part 90.
C. Impact of Rulemaking
The U.S. Department of Labor (DOL) will likely amend its Black Lung
Benefits Act (BLBA) program regulations to correspond with the changes
proposed here. The BLBA provides disability compensation and medical
benefits to miners disabled by pneumoconiosis and monthly compensation
to their eligible survivors (30 U.S.C. 901-944). Because DOL is
required to consult with NIOSH on the development of criteria for
medical tests for coal miners (30 U.S.C. 902(f)(1)(D)), DOL has modeled
its technical requirements for chest radiographs on those adopted by
NIOSH for the Coal Workers' Health Surveillance Program (see 20 CFR
718.102 and 20 CFR Part 718 Appendix A). DOL's Occupational Safety and
Health Administration (OSHA) might also consider amending its current
asbestos regulations for general industry, shipyard employment, and
construction (29 CFR 1910.1001 Appendix E, 29 CFR 1915.1001 Appendix E,
and 29 CFR 1926.1101 Appendix E, respectively). OSHA's asbestos
regulations are related to this proposed rulemaking, although they are
not explicitly linked by statute or regulation.
The DOL standards refer to chest ``roentgenograms,'' an outdated
term which NIOSH proposes to replace with the more contemporary
``radiograph'' as discussed below in the summary of the proposed
digital standards. The DOL standards also rely upon the same ILO
standards for the classification of radiographs, and might need to be
amended to comport with the 2011 version of the ILO Classification, as
referenced in this proposed rule. Finally, the DOL standards refer to
film-based images and might need to be expanded to refer to digitally-
acquired images in order to allow for such images to be used for
purposes of determining eligibility for compensation.
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III. Summary of Proposed Rule
A. Subpart--Chest Radiographic Examinations
This proposed rule would establish new requirements for digital
radiography under existing part 37 of 42 CFR--Specifications for
Medical Examinations of Underground Coal Miners. The new provisions
would supplement and update the existing requirements for film-screen
radiographs by establishing standards for digital radiographs. The
following is a section-by-section summary which describes and explains
the provisions of the rule. Table 1 matches the current regulatory
provisions with the corresponding proposed provisions. The public is
invited to provide comment on any aspect of the proposed rule. The
proposed regulatory text for the proposed rule is provided in the last
section of this notice.
Table 1--New and Proposed Provisions
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Current regulation Proposed regulation
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37.2 Definitions 37.2 Definitions
37.3 Chest roentgenograms required 37.3 Chest radiographs required for
for miners miners
37.4 Plans for chest 37.4 Plans for chest radiographic
roentgenographic examinations examinations
37.5 Approval of plans 37.5 Approval of plans
37.6 Chest roentgenographic 37.6 Chest radiographic
examinations conducted by the examinations conducted by the
Secretary Secretary
37.7 Transfer of affected miner to 37.7 Transfer of affected miner to
less dusty area less dusty area
37.8 Roentgenographic examination 37.8 Radiographic examination at
at miner's expense miner's expense
37.20 Miner identification document 37.20 Miner identification document
37.40 General provisions 37.40 General provisions
37.41 Chest roentgenogram 37.41 Chest radiograph
specifications specifications--film
37.42 Approval of roentgenographic 37.42 Chest radiograph
facilities specifications--digital
radiography systems
37.43 Protection against radiation 37.43 Approval of radiographic
emitted by Roentgenographic facilities that use film
equipment
37.44 Approval of radiographic
facilities that use digital
radiography systems
37.45 Protection against radiation
emitted by radiographic equipment
37.50 Interpreting and classifying 37.50 Interpreting and classifying
chest roentgenogram chest radiographs--film
37.51 Proficiency in the use of 37.51 Interpreting and classifying
systems for classifying the chest radiographs--digital
pneumoconioses radiography systems
37.52 Method of obtaining 37.52 Proficiency in the use of
definitive interpretations systems for classifying the
pneumoconioses
37.53 Notification of abnormal 37.53 Method of obtaining
roentgenographic findings definitive interpretations
37.54 Notification of abnormal
radiographic findings
37.60 Submitting required chest 37.60 Submitting required chest
roentgenograms and miner radiographs and miner
identification documents identification documents
37.70 Review of interpretations 37.70 Review of interpretations
37.80 Availability of records 37.80 ability of records
37.200 Scope 37.200 Scope
37.201 Definitions 37.201 Definitions
37.202 Payment for autopsy 37.202 Payment for autopsy
37.203 Autopsy specifications 37.203 Autopsy specifications
37.204 Procedure for obtaining 37.204 Procedure for obtaining
payment payment
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Section 37.1 Scope
This existing section provides the scope of these provisions, and
remains unchanged from the current regulation.
Section 37.2 Definitions
This existing section contains definitions for terms that appear
throughout part 37. A number of terms appearing in the current
regulations remain unchanged, including ``Act,'' ``convenient time and
place,'' ``MSHA,'' ``miner,'' ``operator,'' and ``Secretary.''
This section proposes to amend the following terms to reflect
updated terminology and references: ``NIOSH,'' and ``chest
radiograph.'' We propose to change ``pre-employment physical
examination'' to ``pre-placement physical examination'' to be
consistent with the requirements of the Americans with Disabilities Act
of 1990 (42 U.S.C. 12112(d)) (ADA). The ADA prohibits an employer from
asking or requiring a job applicant to take a medical examination or
inquiring about whether an applicant has a disability before an offer
of employment has been made. However, the ADA does allow an employer to
require a medical examination after an offer of employment has been
made, subject to certain restrictions. ``Panel of B Readers'' would be
amended to indicate that the panel comprises all currently-approved B
Readers.
Finally, this section includes definitions of the following
proposed new terms: ``digital radiography systems,'' ``computed
radiography,'' ``digital radiography,'' ``NIOSH representatives,''
``qualified medical physicist,'' ``radiographic technique chart,''
``radiologic technologist,'' and ``soft copy.''
Section 37.3 Chest Radiographs Required for Miners
This existing section requires mine operators to provide miners an
opportunity to receive a chest radiograph. We propose a change to this
provision to delete and replace outdated text. For example, in Sec.
37.3(a), ``roentgenogram'' would be replaced by ``radiograph.''
Similarly in Sec. 37.3(a)(1), ``ALOSH'' would be replaced with
``NIOSH.''
Paragraph (b)(1) would be amended to remove reference to a pre-
employment physical examination, which is prohibited by the Americans
with Disabilities Act of 1990 (42 U.S.C. 12112(d)). Paragraph (b)(3)
would be amended to further clarify the classification of simple
pneumoconioses.
[[Page 1364]]
Section 37.4 Plans for Chest Radiographic Examinations
This existing section requires that mine operators submit to NIOSH
a Coal Mine Operator's Plan (Form CDC/NIOSH (M)2.10, OMB 0920-0020,
exp. June 30, 2014) for chest radiographic examinations, including the
beginning and ending dates of the 6-month period for voluntary
examinations, and the name and location of the approved X-ray facility
or facilities.
We propose to amend Sec. 37.4(a), (d), (e), and (f) to update
terminology to reflect ``radiographic'' for ``roentgenographic'' and
``NIOSH'' for ``ALOSH.''
We propose to amend Sec. 37.4(a)(3) to specifically require the
mine operator to submit a roster with the names and current addresses
of covered miners with the operator's proposed plan. This is current
practice and permits mailings directly from NIOSH to miners, which both
emphasizes the extent of the confidentiality exercised by the program
and explains the importance of the health surveillance program. As
discussed above, such direct communication from NIOSH has proven
important in encouraging miners' participation.
We propose to amend Sec. 37.4(a)(6) to specify that when a coal
mine operator examination plan lists a NIOSH-approved X-ray facility
that uses a digital radiographic system, the listed physician who
provides the first clinical reading of a coal miner's digital chest
radiograph must have appropriate qualifications, but is not required to
perform an ILO classification for pneumoconiosis. These initial
clinical readings would therefore not be required to meet the
specifications for pneumoconiosis classification listed in Sec. 37.51
(b), (c), (d), and (e). This should increase the number of digital
radiographic facilities available to miners that can be listed by coal
mine operators on examination plans.
We propose to amend Sec. 37.4(a)(7)(ii) to extend the existing
confidentiality provisions for film radiographs to digital radiographs,
including requiring, to the extent that is technically feasible for the
imaging system used, the permanent deletion or rendering permanently
inaccessible of all digital files at the facility. We further propose
to amend this section to be consistent with the requirements of the
Americans with Disabilities Act, which prohibits the use of pre-
employment medical examinations. We propose to strike the reference in
this paragraph to the pre-employment examination and disclosure of
information gained during that examination.
Section 37.5 Approval of Plans
This existing section outlines the process undertaken by the
Secretary of HHS to approve or deny approval of a Coal Mine Operator's
Plan (Form CDC/NIOSH (M)2.10, OMB 0920-0020, exp. June 30, 2014). We
propose to amend this section to redact outdated text and to correct
gender-exclusive language.
Section 37.6 Chest Radiographic Examinations Conducted by the Secretary
This existing section details the conditions under which the HHS
Secretary will determine whether to conduct a chest radiographic
examination. We propose to amend this section to replace outdated text
with current terminology.
Section 37.7 Transfer of Affected Miner to Less Dusty Area
Under 30 CFR part 90, miners whose radiographs show specific
categories of pneumoconiosis are offered the right to frequent
workplace dust monitoring, and transfer to a job environment with not
more than 1 mg/m\3\ respirable dust levels, if needed and such a job is
available at the mine. If such a work location is not available,
transfer is offered to the job with the lowest exposure below 2 mg/
m\3\, which is the current permissible exposure limit for respirable
dust enforced by MSHA in coal mines. We propose to amend this section
to replace outdated text with current terminology. Also, we propose to
replace ``2 mg/m\3\'' with ``the maximum respirable dust concentration
permitted by MSHA'' and replace ``1 mg/m\3\'' with ``50 percent of the
maximum respirable dust concentration permitted by MSHA.'' The revised
wording would not impact current requirements; however it would remain
consistent with any MSHA rulemaking that alters the relevant
permissible exposure limits.
Section 37.8 Radiographic Examination at Miner's Expense
This existing section provides for any miner who wishes to obtain a
radiographic examination at his or her own expense. We propose to amend
this section only to replace the outdated ``ALOSH'' with ``NIOSH.''
Section 37.20 Miner Identification Document
This existing section requires the completion of a Miner
Identification Document (Form CDC/NIOSH (M)2.9, OMB 0920-0020, exp.
June 30, 2014) for each miner when the chest radiograph is made. We
propose to amend this section only to replace ``roentgenographic'' and
``roentgenogram'' with ``radiographic'' and ``radiograph.''
Section 37.40 General Provisions
This existing section outlines general provisions for chest
radiographic examinations. We propose to amend this section to update
the terminology.
Section 37.41 Chest Radiograph Specifications--Film
This existing section establishes performance standards for the
acquisition of chest radiographs using film-screen technology. We
propose to amend this section to update terminology and standards. We
propose to add Sec. 37.41(c) to require that a radiologic technologist
perform the radiograph. This requirement is new. The existing rule does
not clearly specify the qualifications of the provider who performs the
radiologic examination. In light of ongoing concerns related to
radiation exposure, it is necessary to specify that this provider have
documented qualifications.
We propose to amend Sec. 37.41(i)(7) to remove the current
language, ``[w]hen using over 90kV,'' because proposed Sec. 37.42(e),
below, would require that radiographs be made by units having
generators with a minimum rating of 300 mA at 125 kVp. We also propose
to amend Sec. 37.41(m) to remove the word ``densitometric,'' as the
test object may evaluate characteristics of the exposure in addition to
density.
We also propose to amend Sec. 37.41(h) to remove the reference to
Part F of the Suggested State Regulations for the Control of Radiation,
of the Conference of Radiation Control Program Directors (Rev 2009).
The beam limiting device must be of the type described in 21 CFR
1020.31(d), (e), (f), and (g).
Finally, we propose to remove Sec. 37.41(i)(9), which requires
that each facility shall establish a formal quality assurance program.
This requirement would be instead inserted into proposed Sec. 37.43,
which would set standards for the approval of radiographic facilities
that use film (see below).
Section 37.42 Chest Radiograph Specifications--Digital Radiography
Systems
This proposed section establishes performance standards for the
acquisition of chest radiographs using digital radiography systems,
including digital radiography and computed radiography. We propose
adding this
[[Page 1365]]
new section in its entirety; it is patterned after the existing Sec.
37.41--Chest radiographic specifications for film.
Proposed Sec. 37.42(a) would establish basic logistical
requirements for conducting chest radiographic examination. For
example, under this provision, the imaging facility would be required
to provide a dressing area. This provision is identical to the existing
regulation for film, Sec. 37.41(b).
Proposed Sec. 37.42(b) would specify minimum requirements for the
position of the subject of the radiograph and for the resolution and
positioning of the resulting image. The required size and positioning
of the X-ray detectors for digital systems is identical to that in the
existing regulation for film-screen systems (Sec. 37.41(a)). Exact
specifications for the digital imaging detector are provided because
detectors must provide sufficient image size and gray scale depth to
demonstrate the required subtle contrasts, and sufficient density of
pixels to offer adequate resolution for the fine linear fibrotic
shadows.\10\ The specification of a maximum pixel pitch of 200 [mu]m, a
minimum gray-scale bit depth of 10, and spatial resolution of at least
2.5 line pairs per millimeter are based upon the existing peer-reviewed
research comparing digital and traditional imaging and ensures that the
use of digital radiography systems will not result in reduced ability
to recognize and quantify the abnormalities.\11\ Commercially-available
imaging systems are able to meet these specifications.\12\
---------------------------------------------------------------------------
\10\ Samei E [2008]. Acquisition of digital chest images for
pneumoconiosis classification: Methods, procedures, and hardware.
In: NIOSH. Application of the ILO International Classification of
Radiographs of Pneumoconioses to Digital Chest Radiographic Images:
A NIOSH Scientific Workshop. Cincinnati, OH: U.S. Department of
Health and Human Services, Public Health Service, Centers for
Disease Control and Prevention, National Institute for Occupational
Safety and Health. DHHS (NIOSH) Publication No. 2008-139.
\11\ Franzblau A, Kazerooni EA, Sen A, Goodsitt MM, Lee SY,
Rosenman KD, Lockey JE, Meyer CA, Gillespie BW, Petsonk EL, Wang ML
[2009]. Comparison of digital radiographs with film radiographs for
the classification of pneumoconiosis. Acad Radiol 16(6):669-677.
Sen A, Lee SY, Gillespie BW, Kazerooni EA, Goodsitt MM,
Rosenman KD, Lockey JE, Meyer CA, Petsonk EL, Wang ML, Franzblau A
[2010]. Comparison of reliability of classification for
pneumoconiosis of film and digital radiographs: A modeling approach.
Acad Radiol 17(4):511-519.
Laney AS, Petsonk EL, Wolfe AL, Attfield MD [2009]. Comparison
of storage phosphor computed radiography with conventional film-
screen radiography in the recognition of pneumoconiosis. Eur Respir
J, published ahead of print November 19, 2009.
\12\ Flynn MJ [2008]. Image presentation: Implications of
processing and display. In: NIOSH. Application of the ILO
International Classification of Radiographs of Pneumoconioses to
Digital Chest Radiographic Images: A NIOSH Scientific Workshop.
Cincinnati, OH: U.S. Department of Health and Human Services, Public
Health Service, Centers for Disease Control and Prevention, National
Institute for Occupational Safety and Health. DHHS (NIOSH)
Publication No. 2008-139.
---------------------------------------------------------------------------
Proposed Sec. 37.42(c) would require that chest radiographs
obtained pursuant to these provisions must be made by a qualified
radiologic technologist.
Proposed Sec. 37.42(d) would specify the required size of the X-
ray machine's focal spot. This proposed provision would follow the
existing regulation for film (Sec. 37.41(c)).
Proposed Sec. 37.42(e) would specify the minimum amperage and
voltage required to produce chest radiographs. This section would be
identical to the existing regulation for film, Sec. 37.41(d), but with
updated terminology.
Proposed Sec. 37.42(f) would require radiographic equipment be
used with a power supply that complies with the X-ray machine's
manufacturer specifications. Adequately conditioned power is needed for
consistent generation of the radiation exposure needed for imaging. The
requirement to meet minimum power supply recommendations for the
equipment assures that the imaging system can perform as intended and
specified by the manufacturer.
Proposed Sec. 37.42(g) would require that radiographic equipment
has a beam-limiting device to reduce the amount of scatter and off-
focus radiation. While this provision largely mirrors the provision for
film-screen systems (Sec. 37.41(g)), it also specifies that electronic
means for limiting the size of the final image shall not be used.
Electronic ``shutters'' are available for some digital radiography
systems and can constrain image size but do not limit radiation
exposure, and thus their use is prohibited to reduce the adverse health
impact on the miner of unnecessary exposure to ionizing radiation
associated with the radiograph.
Proposed Sec. 37.42(h) would require the use of radiographic
technique charts that are developed specifically for the X-ray system
and detector combination used at a facility. If automated exposure
control devices are used, they should be documented using
professionally recommended methods; such information should be stored
for 5 years after the miner's examination. NIOSH believes that
retaining such records for 5 years is already standard business
practice. Maintaining records is necessary to permit individuals at the
facility to audit their own adherence to the guidance. Failure to
maintain documentation is much easier to demonstrate and enforce than
specific elevated radiation exposures for individual examinations. Five
years was chosen as a compromise between minimizing records storage
burden and maintaining the ability to perform meaningful audits both
for NIOSH and for the facility staff.
The proposed specifications for digital radiography systems follow
existing regulations for film (Sec. 37.41(h)(3)) requiring specified
exposure settings. Because of the recognized potential for higher
ionizing radiation exposures using digital radiography systems, we have
included additional requirements to limit these exposures in accordance
with recommendations established by the American Association of
Physicists in Medicine.\13\
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\13\ Shepard SJ, Wang J, Flynn M, Gingold E, Goldman L, Krugh K,
Leong DL, Mah E, Ogden K, Peck D, Samei E, Willis C [2009]. An
exposure indicator for digital radiography. Report of AAPM Task
Group 116. College Park, MD: American Association of Physicists in
Medicine. AAPM Report No. 116.
Rossi R, Lin PJ, Rauch P, Strauss K [1985]. Performance
specifications and acceptance testing for X-ray generators and
automatic exposure control devices. Report of the Diagnostic X-Ray
Imaging Committee Task Group on Performance Specifications and
Acceptance Testing for X-Ray Generators and Automatic Exposure
Control Devices. AAPM Report No. 14.
Seibert JA, Bogucki TM, Ciona T, Huda W, Karellas A, Mercier J,
Samei E, Shepart SJ, Steward B, Strauss K, Suleiman O, Tucker D,
Uzenoff R, Weiser JC, Willis C [2006]. Acceptance testing and
quality control of photostimulable storage phosphor imaging systems.
Report of AAPM Task Group 10. College Park, MD: American Association
of Physicists in Medicine. AAPM Report No. 93.
---------------------------------------------------------------------------
Proposed Sec. 37.42(i)(1) would require that the maximum exposure
time not exceed 50 milliseconds except for subjects of a certain size.
This provision would mirror the existing regulation for film-screen
technology (Sec. 37.41(h)(1), although the text is modified to use
contemporary timing units.
Proposed Sec. 37.42(i)(2) would specify the required distance from
the source or focal spot to the detector. This provision mirrors the
existing regulation for film (Sec. 37.41(g)) but with additional text
clarifying metric units.
Proposed Sec. 37.42(i)(3) would specify the required exposure
setting for digital radiographs and incorporate by reference current
professional standards intended to limit exposures from digital
radiographs. This proposed section mirrors existing regulations for
film-screen technology (Sec. 37.41(h)(3)).
Proposed Sec. 37.42(i)(4) would establish that digital radiography
system performance, including image signal-to-noise and detective
quantum efficiency, be evaluated and meet the standards of
[[Page 1366]]
a qualified medical physicist in accordance with current professional
standards, which are incorporated by reference in this section. This
section would also govern the use of image management software. Digital
systems use direct or indirect quantification of electronic signals
from the detectors, and thus the character and quality of the resulting
image is affected by both hardware and software signal management. To
ensure that images collected for the purposes of this regulation using
digital systems are adequate, it is important that approved imaging
systems satisfy the relevant contemporary professionally recommended
minimum performance criteria. Further, to improve comparability in the
character of chest radiographic images submitted by different approved
facilities for the purposes of this regulation, this section would
require that image management software and settings for routine chest
imaging be used.
In addition to management software, manufacturers of digital
radiography systems provide unique proprietary versions of image
modifying software, and the resulting images have distinctly different
appearances. There is currently no scientific consensus that a specific
approach to image enhancement software provides superior performance in
imaging pneumoconiotic opacities. Therefore, this section would
prohibit the use of image enhancement, except to the extent that some
enhancement features might be integral to the digital radiography
system and hence are not elective; for such cases, this section would
specify that image enhancement be minimized to the extent permitted by
the system.
Proposed Sec. 37.42(i)(5) would establish the Digital Imaging and
Communications in Medicine (DICOM) standard \14\ as the relevant data
storage and transmission standard. At a 2008 NIOSH workshop, entitled
Application of the ILO International Classification of Radiographs of
Pneumoconioses to Digital Chest Radiographic Images, participants
evaluated digital chest radiographic image file formats, and found that
aside from DICOM, there are currently no other adequately specified
digital image formats that support the resolution, security, and
interoperability required for this application.\15\ Chest radiographic
images obtained using digital systems are stored and transferred as
electronic data files. To ensure the integrity of the information,
patient/worker confidentiality, full access by appropriate parties to
the complete data file, compatibility with hardware systems from
various manufacturers, and uniformity of image viewing and data
management, the proposed rule would require that images collected for
the purposes of this regulation using digital systems be formatted
using the industry standardized electronic format, and that any data
compression employed be lossless. Physical, technical, and
administrative controls are specified to prevent unauthorized access to
protected health information and confidential medical findings, during
data acquisition, storage, and transfer. To support the uniform
grayscale standard display function of image display devices, images
must be formatted as DICOM ``DX'' objects.\16\ To enable auditing of
radiation exposure data over time, the facility would be required to
maintain either written or electronic records, formatted according to
industry standards when possible.
---------------------------------------------------------------------------
\14\ DICOM is a widely-accepted standard for handling, storing,
printing, and transmitting medical imaging information. DICOM is
managed by the National Electrical Manufacturers Association.
\15\ NIOSH [2008]. Application of the ILO International
Classification of Radiographs of Pneumoconioses to Digital Chest
Radiographic Images: A NIOSH Scientific Workshop. Cincinnati, OH:
U.S. Department of Health and Human Services, Public Health Service,
Centers for Disease Control and Prevention, National Institute for
Occupational Safety and Health. DHHS (NIOSH) Publication No. 2008-
139.
\16\ Clunie DA. Standardizing file formats, security, and
integration of digital chest image files for pneumoconiosis
classification. In: NIOSH. Application of the ILO International
Classification of Radiographs of Pneumoconioses to Digital Chest
Radiographic Images: A NIOSH Scientific Workshop. Cincinnati, OH:
U.S. Department of Health and Human Services, Public Health Service,
Centers for Disease Control and Prevention, National Institute for
Occupational Safety and Health. DHHS (NIOSH) Publication No. 2008-
139.
---------------------------------------------------------------------------
Proposed Sec. 37.42(i)(6) would allow NIOSH the discretion to
require the use of a test object for an evaluation of image quality.
This section is identical to existing film regulation Sec. 37.41(l),
although the term `densitometric' has been omitted in describing the
test object, as the object may evaluate characteristics of the exposure
in addition to density.
Proposed Sec. 37.42(i)(7) would require computed radiography (X-
ray image acquisition systems that detect signals using a cassette-
based photostimulable storage phosphor) imaging plates to be inspected
regularly and cleaned when necessary. This specification preserves the
existing required periodicity of cleaning because, for storage phosphor
digital systems as with film-screen systems, periodic cleaning of
equipment is necessary to reduce the possibility of image artifacts.
Proposed Sec. 37.42(i)(8) would require the use of a grid or air
gap for reducing radiation scatter. This section mirrors the existing
regulation for film (Sec. 37.41(h)(7)) with additional language
addressing interference patterns. Such patterns can arise using digital
techniques, and can interfere with image classification and the
detection of abnormalities.
Proposed Sec. 37.42(i)(9) would establish the geometry of the
radiographic system. This section mirrors existing film regulation
Sec. 37.41(h)(8), with text amended to reflect the digital technology
rather than film.
Proposed Sec. 37.42(i)(10) would require that radiographic
equipment meet recommended environmental temperature and humidity
thresholds set by the manufacturer. This requirement would be exclusive
to digital radiography systems, and would ensure that the imaging
system can perform as intended and as specified by the manufacturer.
Proposed Sec. 37.42(i)(11) would ensure that the miner receives a
chest radiograph determined to be of acceptable quality before being
advised that the examination is concluded. In the event of a
substandard radiograph, under this section, a miner would immediately
be given another. Finally, this section would also require that
unacceptable digital image files immediately be permanently deleted or
rendered inaccessible in the event that permanent deletion is not
technologically feasible. These requirements are identical to that for
film (Sec. 37.41(j)) except that the text refers to the deletion of
digital files rather than the disposal of films.
Proposed Sec. 37.42(j)(1) and (2) would prohibit the use of
digital images derived from film-screen chest radiographs for the
purposes of this rule. Similarly, images acquired using digital systems
and then printed on transparencies would also be prohibited. Research
has shown that these approaches do not assure similar performance to
that obtained from film under the existing regulations (Sec.
37.41).\17\
---------------------------------------------------------------------------
\17\ Samei E [2008]. Acquisition of digital chest images for
pneumoconiosis classification: Methods, procedures, and hardware.
In: NIOSH. Application of the ILO International Classification of
Radiographs of Pneumoconioses to Digital Chest Radiographic Images:
A NIOSH Scientific Workshop. Cincinnati, OH: U.S. Department of
Health and Human Services, Public Health Service, Centers for
Disease Control and Prevention, National Institute for Occupational
Safety and Health. DHHS (NIOSH) Publication No. 2008-139.
Franzblau A, Kazerooni EA, Sen A, Goodsitt MM, Lee SY, Rosenman
KD, Lockey JE, Meyer CA, Gillespie BW, Petsonk EL, Wang ML [2009].
Comparison of digital radiographs with film radiographs for the
classification of pneumoconiosis. Acad Radiol 16(6):669-677.
Suganuma N, Murata K, Kusaka Y [2008]. CR and FPD DR chest
radiographic image parameters for the pneumoconioses: The Japanese
approach and experience. In: NIOSH. Application of the ILO
International Classification of Radiographs of Pneumoconioses to
digital chest radiographic images: A NIOSH Scientific Workshop.
Cincinnati, OH: U.S. Department of Health and Human Services, Public
Health Service, Centers for Disease Control and Prevention, National
Institute for Occupational Safety and Health. DHHS (NIOSH)
Publication No. 2008-139.
Franzblau A, Kazerooni EA, Goodsitt M [2009]. Digital X-ray
imaging in pneumoconiosis screening: Future challenges for the NIOSH
B Reader Program. In: NIOSH. The NIOSH B Reader Certification
Program: Looking to the future. Cincinnati, OH: U.S. Department of
Health and Human Services, Public Health Service, Centers for
Disease Control and Prevention, National Institute for Occupational
Safety and Health. DHHS (NIOSH) Publication No. 2009-140.
---------------------------------------------------------------------------
[[Page 1367]]
Section 37.43 Approval of Radiographic Facilities That Use Film
Proposed Sec. 37.43 would comprise the current requirements in
existing Sec. 37.42--Approval of roentgenographic facilities. Proposed
Sec. 37.43(a) would base facility eligibility to participate in the
Coal Workers' Health Surveillance Program on a demonstrated ability to
make high quality diagnostic chest radiographs. This section remains
unchanged from the existing provision but for the addition of text
indicating that an object other than the plastic step wedge objects may
be used. Newer test objects have become available, and in the future,
NIOSH may want to use a more compact and capable test object that is
simpler to use than the step wedges.
Proposed Sec. 37.43(b) would specify requirements for an X-ray
Facility Certification Document (Form CDC/NIOSH (M)2.11, OMB 0920-0020,
exp. June 30, 2014) describing each X-ray unit to be used to make chest
radiographs. This section would be unchanged from the existing Sec.
37.42(c) except for the replacement of outdated terminology, including
incorporation by reference of National Council on Radiation Protection
and Measurements (NCRP) Report No. 102.
Proposed Sec. 37.43(c) would establish that radiographs submitted
with a facility application be evaluated by a qualified consultant or
one or more individuals selected by NIOSH from the panel of B Readers.
This section would be substantively unchanged from the existing Sec.
37.42(d), although we propose to amend this section to replace outdated
text with current terminology, specifically by substituting the term
'medical physicist' for 'radiological physicist.'
Proposed Sec. 37.43(d) would describe NIOSH's authority to conduct
a physical inspection of the applicant's facility to determine if the
requirements of this subpart are being met. We propose to amend this
section from the existing Sec. 37.42(e) by updating outdated
terminology.
Proposed Sec. 37.43(e) would allow NIOSH the discretion to require
a facility to resubmit radiographs of a test object, sample
radiographs, or a Facility Certification Document for quality control
purposes. It would also establish the conditions under which NIOSH may
suspend or withdraw a facility's approval and how notice must be given.
We propose to amend this section from the existing Sec. 37.43(f) by
updating outdated terminology.
Proposed Sec. 37.43(f) would require that facilities establish a
formal quality assurance program conforming to standards published by
the American Association of Physicists in Medicine and incorporated by
reference here. This provision would replace existing Sec.
37.41(h)(9), which requires that facilities establish a formal quality
assurance program, with more specific quality assurance program
guidelines. We propose that the program must be written, address
radiation exposures, equipment maintenance, and image quality, and
conform to the referenced professional standards. Several years ago,
NIOSH initiated an image quality feedback program to try to improve the
film quality; NIOSH therefore wishes to ensure that the facilities have
documented quality assurance programs. This provision will also permit
NIOSH to easily request copies of the documentation, and thus more
easily determine if a facility has adequately addressed their image
quality issues.
Proposed Sec. 37.43(g) would add the explicit requirement that
facilities adhere to Federal, State, and local laws, as applicable, to
protect the confidentiality and privacy of coal miners participating in
the Program. Through this provision, NIOSH seeks to ensure that X-ray
facilities maintain miners' sensitive health information securely and
protect it from disclosure to the extent permitted by law.
Section 37.44 Approval of Radiographic Facilities That Use Digital
Radiography Systems
Proposed Sec. 37.44 would establish standards for the approval of
radiographic facilities that use digital radiography systems. These
standards mirror those for film-screen technology.
Proposed Sec. 37.44(a)(1) would specify the requirements for a
facility approval application, including an image of a test object, and
six or more sample radiographs of quality acceptable to one or more
individuals selected by NIOSH from the panel of B Readers and a
qualified medical physicist. The existing requirements for facilities
to demonstrate radiograph quality are continued (Sec. 37.42(b)) but to
reduce the burden on facilities, radiographs made up to 60 days prior
to the application may be submitted. The time extension (from the
existing 15 days for film-based systems) eases the burden on applicants
by giving them a longer window of time to select a representative
image, while continuing to ensure that the images that are submitted
reflect the facility's contemporary image quality; changes in digital
image quality are unlikely to occur in the time frame indicated (i.e.,
60 days). In the past, wet systems such as film processors and
chemicals could get diluted or dirty in shorter times when many films
were processed, however, because there are no liquids and very few
moving parts in digital systems, the time frame for quality
deterioration is longer, and thus a longer time is more convenient but
still should be representative of the digital image quality. This
provision would also require the image files to be submitted using a
secure electronic file transfer method approved by NIOSH, or on
standard portable media and meet the current DICOM specifications for
diagnostic media interchange.
Proposed Sec. 37.44(a)(2) would specify the contents of the X-ray
Facility Certification Document. This paragraph would continue the
existing requirement for documentation and inspection of eligible
facilities by a qualified expert within 1 year preceding the date of
the application (Sec. 37.42(c)), and would clarify that the expert
must be a medical physicist. NIOSH has always expected that a medical
physicist perform these evaluations, and now intends to codify that
expectation.
Proposed Sec. 37.44(b) would require that facilities maintain
relevant local, State, or Federal licensure and certification. The
existing requirement that radiographic facilities conform to applicable
State and Federal regulations (Sec. 37.43) is continued.
Proposed Sec. 37.44(c) would allow NIOSH the discretion to conduct
a site inspection of the facility. Existing regulations for film (Sec.
37.42(e)) specify periodic inspections, and this requirement is
continued for digital systems.
Proposed Sec. 37.44(d) would allow NIOSH the discretion to require
a facility to resubmit image files of the test object, sample
radiographs, or
[[Page 1368]]
Facility Certification Document. The provision would also authorize
NIOSH to suspend or withdraw a facility's approval when warranted due
to noncompliance with provisions of this rule.
Proposed Sec. 37.44(e) would require that facilities have a
qualified medical physicist on site or available as a consultant. To
minimize risks and assure standardized and predictable image quality
from sophisticated digital radiography systems, facilities must have
available highly trained individuals who are skilled in evaluating the
equipment, methods, and procedures.\18\
---------------------------------------------------------------------------
\18\ Samei E [2008]. Acquisition of Digital Chest Images for
Pneumoconiosis Classification: Methods, Procedures, and Hardware.
In: NIOSH. Application of the ILO International Classification of
Radiographs of Pneumoconioses to Digital Chest Radiographic Images:
A NIOSH Scientific Workshop. Cincinnati, OH: U.S. Department of
Health and Human Services, Public Health Service, Centers for
Disease Control and Prevention, National Institute for Occupational
Safety and Health. DHHS (NIOSH) Publication No. 2008-139.
---------------------------------------------------------------------------
Proposed Sec. 37.44(f) would require that facilities document the
findings by the medical physicist that each image acquisition system
has met initial specifications and standards of the equipment
manufacturer and performance testing. Since the 1980s, major advances
have occurred in the practice of clinical radiology, most notably in
the widespread adoption of digital technologies and systems for image
acquisition, storage, transfer, and display.\19\ These digital
technologies offer unique benefits for the identification and
classification of pneumoconiosis, but due to the added complexities of
digital radiography systems compared with film-screen radiology, these
benefits may only be realized with proper implementation and
utilization of the digital systems.\20\ To assure that the systems
perform at the level required to meet the purposes of this Part,
performance must be assessed by qualified individuals.
---------------------------------------------------------------------------
\19\ NIOSH [2008]. Application of the ILO International
Classification of Radiographs of Pneumoconioses to Digital Chest
Radiographic Images: A NIOSH Scientific Workshop. Cincinnati, OH:
U.S. Department of Health and Human Services, Public Health Service,
Centers for Disease Control and Prevention, National Institute for
Occupational Safety and Health. DHHS (NIOSH) Publication No. 2008-
139.
\20\ Samei E, Ravin CE [2008]. Assuring image quality for
classification of digital chest radiographs. In: NIOSH. Application
of the ILO International Classification of Radiographs of
Pneumoconioses to Digital Chest Radiographic Images: A NIOSH
Scientific Workshop. Cincinnati, OH: U.S. Department of Health and
Human Services, Public Health Service, Centers for Disease Control
and Prevention, National Institute for Occupational Safety and
Health. DHHS (NIOSH) Publication No. 2008-139.
---------------------------------------------------------------------------
Proposed Sec. 37.44(g) would require facilities to implement a
quality assurance program, and would incorporate by reference the
standards set by the American Association of Physicists in Medicine.
This provision continues the existing requirement for a quality control
program, (Sec. 37.41(h)(9)) and further specifies professionally
recommended procedures that must be an integral part of the operation
of each digital radiography system. To ensure that radiologic
examinations required under this Part are safe, reliable, and accurate,
facilities that are approved to provide examinations using digital
equipment must demonstrate that personnel, equipment, and procedures
adhere to professionally accepted guidelines.\21\
---------------------------------------------------------------------------
\21\ Franzblau A, Kazerooni EA, Goodsitt M [2009]. Digital X-ray
imaging in pneumoconiosis screening: Future challenges for the NIOSH
B Reader Program. In: NIOSH. The NIOSH B Reader Certification
Program: Looking to the future. Cincinnati, OH: U.S. Department of
Health and Human Services, Public Health Service, Centers for
Disease Control and Prevention, National Institute for Occupational
Safety and Health. DHHS (NIOSH) Publication No. 2009-140.
NIOSH [2008]. Application of the ILO International
Classification of Radiographs of Pneumoconioses to Digital Chest
Radiographic Images: A NIOSH Scientific Workshop. Cincinnati, OH:
U.S. Department of Health and Human Services, Public Health Service,
Centers for Disease Control and Prevention, National Institute for
Occupational Safety and Health. DHHS (NIOSH) Publication No. 2008-
139.
---------------------------------------------------------------------------
Proposed Sec. 37.44(g)(1) would require that facility approval
applications include a comprehensive assessment by a qualified medical
physicist within 12 months prior to application. This paragraph would
incorporate by reference guidelines established by the American
Association of Physicists in Medicine. This provision continues the
existing requirement (Sec. 37.42(c)).
Proposed Sec. 37.44(g)(2) would require the use of radiographic
technique charts developed for the specific X-ray system and detector
combination used at the facility. This section would incorporate by
reference monitoring methods specified by the American Association of
Physicists in Medicine, and radiation exposure reference levels
specified by the American College of Radiology. Unlike film-screen
radiology, digital radiography systems are susceptible to dose
creep.\22\ Dose creep in this setting involves increasing examinee
radiation exposures over time for similar types of examinations (e.g.,
chest radiographs) performed at a facility. The tendency to increase
radiation exposures over time, beyond the levels necessary, results
from the characteristics of digital image detectors (which provide
excellent image quality when images are overexposed, but suboptimal
image quality when underexposed) combined with the desire on the part
of facilities to avoid repeat examinations. For this reason, as
recommended by professional bodies, facilities utilizing digital
systems for examinations under this Part are required to take
additional steps to ensure optimal exposures, and to maintain records
of annual monitoring and evaluation of representative radiation
exposures over time, using standardized methods, metrics, and
documentation.\23\
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\22\ Schaefer-Prokop C, Neitzel U, Venema HW, Uffmann M, Prokop
M [2008]. Digital chest radiography: An update on modern technology,
dose containment and control of image quality. Eur Radiol
18(9):1818-1830.
\23\ Shepard SJ, Wang J, Flynn M, Gingold E, Goldman L, Krugh K,
Leong DL, Mah E, Ogden K, Peck D, Samei E, Willis C [2009]. An
exposure indicator for digital radiography. Report of AAPM Task
Group 116. College Park, MD: American Association of Physicists in
Medicine. AAPM Report No. 116.
ACR Practice Guideline for diagnostic reference levels in
medical X-ray imaging. Revised 2008 (Res. 3).
ACR Technical Standard for diagnostic medical physics
performance monitoring of radiographic and fluoroscopic equipment.
Revised 2006 (Res. 29,16g,17).
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Proposed Sec. 37.44(g)(3) would require that the performance of a
digital radiography device be monitored according the recommendations
of the medical physicist. Facilities would be required to maintain
documentation upon the completion of quality assurance testing, and
make it available to NIOSH for 5 years. NIOSH believes that retaining
such records for 5 years is already standard business practice. This
provision would also specify that certain tests are not required as a
part of the quality assurance program for digital radiography systems
(digital image acquisition systems in which the X-ray signals received
by the image detector are converted to electronic signals without
movable cassettes). This section provides more detailed guidance
specific to the contemporary types of digital systems.
Proposed Sec. 37.44(g)(4) would require that facilities maintain
documentation on the implementation and monitoring of policies and
procedures required under this section. Documentation of key metrics is
essential for facility management to assure adherence to internal
policies, and provides a mechanism for NIOSH inspections to determine
if the purposes of this Part are being met.
Proposed Sec. 37.44(h) would add the explicit requirement that
facilities adhere to Federal laws to protect the confidentiality and
privacy of coal miners participating in the program.
[[Page 1369]]
NIOSH seeks to ensure that miners' sensitive health information remains
secure and is protected to the extent permitted by law.
Section 37.45 Protection Against Radiation Emitted by Radiographic
Equipment
This proposed provision would require that radiographic equipment
conform to applicable State, territorial, and Federal regulations.
Where no State, territorial or Federal regulations apply, the section
would incorporate by reference the recommendations of the NCRP. This
provision is unchanged from the existing Sec. 37.45, although
references for the NCRP recommendations and contact information would
be updated.
Section 37.50 Interpreting and Classifying Chest Radiographs--Film
Proposed procedures for classifying radiographs would be unchanged
from the existing Sec. 37.50, but for updating the requirement that
images be interpreted and classified in accordance with the ILO
International Classification of Radiographs for Pneumoconioses, 2011
edition.\24\ The revised 2011 edition of the Guidelines for the use of
the ILO International Classification of Radiographs of Pneumoconioses
extends the applicability of the prior edition of the Classification to
digital radiographic images of the chest. The proposed section would
retain the existing provision that radiographs must be interpreted by
an A or B Reader who has access to a complete set of the ILO
Classification standard images, but would clarify that initial
interpretations and notification of any findings other than that of
pneumoconiosis shall be performed by a qualified physician. Provisions
referring to view boxes would also be retained. Further, this section
would be newly designated to apply only to film-screen radiographs.
---------------------------------------------------------------------------
\24\ International Labour Office [2011]. Guidelines for the use
of ILO International Classification of Pneumoconiosis, revised
edition 2011). Geneva, Switzerland: International Labour Office.
Occupational Safety and Health Series No. 22 (Rev. 2011).
---------------------------------------------------------------------------
Section 37.51 Interpreting and Classifying Chest Radiographs--Digital
Radiography Systems
Proposed Sec. 37.51(a) and (b) are similar to the first two
provisions of Sec. 37.50 for film radiographs, discussed above.
Clinical readings of digital chest radiographs obtained under this Part
must be performed by physicians who are qualified and licensed and who
read chest radiographs in the normal course of practice. However, in
NIOSH's judgment, it would not be feasible to require that all
physicians who provide the initial readings demonstrate proficiency
with the ILO Classification of digital radiographs as specified in this
Section. Such physicians are not sufficiently available to conduct
these initial readings for coal miners in all locations in the United
States. Thus the proposed rule specifies that a qualified and licensed
physician who reads chest radiographs in the normal course of practice
is qualified to provide interpretation and notification of any abnormal
findings other than pneumoconiosis.
The ILO has recently authorized the use of the ILO Classification
for digital images and authorized a set of standard digital image files
for use during classification. Paragraph Sec. 37.51(b) would specify
that the classification of digital images be done ``in a manner
consistent with the ILO International Classification of Radiographs of
Pneumoconioses 2011.''
Proposed Sec. 37.51(c) would require radiograph interpreters to
have available to them a complete set of NIOSH-approved standard
digital chest radiographic images. The ILO classification system has
provided a standardized approach to recognizing, describing, and
quantifying abnormalities on the chest radiograph caused by dust.\25\ A
set of standard film images is provided by the ILO and required to be
used in side-by-side comparisons when classifying radiographs. These
ILO standard images were originally obtained using film-screen
radiography, without application of edge enhancement or noise reduction
software. Research using film-screen radiographs and classifications
based upon the current ILO standard film radiographs has demonstrated
that chest radiograph classification results correlate significantly
with objective independent measures of dust exposure or lung dust
content.\26\ To maintain the documented validity of the ILO
classification system, the rule specifies that each reader compare
digital images submitted under this regulation with NIOSH-approved
digital versions of the standard images, and that no software
modification of the standard images can be permitted.
---------------------------------------------------------------------------
\25\ Id.
\26\ Ruckley VA, Fernie JM, Chapman JS, Collings P, Davis JM,
Douglas AN, Lamb D, and Seaton A [1984]. Comparison of radiographic
appearances with associated pathology and lung dust content in a
group of coalworkers. Br J Ind Med 41(4): 459-467.
Cockcroft A, Lyons JP, Andersson N, and Saunders MJ [1983].
Prevalence and relation to underground exposure of radiological
irregular opacities in South Wales coal workers with pneumoconiosis.
Br J Ind Med 40(2): 169-172.
---------------------------------------------------------------------------
Proposed Sec. 37.51(d) would require that viewing systems enable
readers to display the chest image at full resolution, side-by-side
with the selected NIOSH-approved standard image for comparison. This
section would establish specifications for image display devices,
including megapixels (MP) and bit depth; displays and associated
graphics cards should meet the specifications of the current DICOM
standard. This section would also set standards for display system
luminance, relative noise, linearity, modulation transfer function
(MTF), frequency, and glare by incorporating AAPM recommendations by
reference. Finally, this section would require that displays be
situated to minimize front surface glare.
Visualization of the shadows on the chest radiograph caused by
dust-related fibrosis is one of the most difficult challenges in
medical diagnostic imaging. The viewing systems must provide sufficient
luminance and gray scale depth to demonstrate the required subtle
contrasts, and sufficient display size and density of pixels to reflect
the resolution of the image file provided by the image detectors and
required to visualize the fine linear fibrotic shadows.\27\ Research
studies have demonstrated that reader recognition of pneumoconiosis on
digital radiology systems can be equivalent to that achieved using
film-screen radiology systems when appropriate system specifications
and devices are employed.\28\ Additionally, adherence to the grayscale
standard display function is required to assure that the appearance
[[Page 1370]]
of the images is independent of the specific digital device used for
display.
---------------------------------------------------------------------------
\27\ Flynn MJ [2008]. Image presentation: Implications of
processing and display. In: NIOSH. Application of the ILO
International Classification of Radiographs of Pneumoconioses to
Digital Chest Radiographic Images: A NIOSH Scientific Workshop.
Cincinnati, OH: U.S. Department of Health and Human Services, Public
Health Service, Centers for Disease Control and Prevention, National
Institute for Occupational Safety and Health. DHHS (NIOSH)
Publication No. 2008-139.
\28\ Franzblau A, Kazerooni EA, Sen A, Goodsitt MM, Lee SY,
Rosenman KD, Lockey JE, Meyer CA, Gillespie BW, Petsonk EL, Wang ML
[2009]. Comparison of digital radiographs with film radiographs for
the classification of pneumoconiosis. Acad Radiol 16(6):669-677.
Sen A, Lee SY, Gillespie BW, Kazerooni EA, Goodsitt MM,
Rosenman KD, Lockey JE, Meyer CA, Petsonk EL, Wang ML, Franzblau A
[2010]. Comparison of reliability of classification for
pneumoconiosis of film and digital radiographs: A modeling approach.
Acad Radiol 17(4):511-519.
Laney AS, Petsonk EL, Wolfe AL, Attfield MD [2009]. Comparison
of storage phosphor computed radiography with conventional film-
screen radiography in the recognition of pneumoconiosis. Eur Respir
J, published ahead of print November 19, 2009.
---------------------------------------------------------------------------
Proposed Sec. 37.51(d)(4) would also require that the measurements
of pleural shadows and parenchymal opacities shall be taken using
calibrated software measuring tools. This section would also require
that, if possible, a record be made of the presentation state. Each
individual reader is generally offered the option to select a specific
setting that he or she judges to optimize the display characteristics
of the chest radiographic image during the classification process;
however, recording of the presentation states and annotations would be
required (with compatible software) and would permit subsequent
evaluation, using a Grayscale Standard Display Function (GSDF)
compliant monitor, of the specific image that was displayed and
interpreted by the reader who performed the classification.\29\
---------------------------------------------------------------------------
\29\ Samei E, Ravin CE [2008]. Assuring image quality for
classification of digital chest radiographs. In: NIOSH. Application
of the ILO International Classification of Radiographs of
Pneumoconioses to Digital Chest Radiographic Images: A NIOSH
Scientific Workshop. Cincinnati, OH: U.S. Department of Health and
Human Services, Public Health Service, Centers for Disease Control
and Prevention, National Institute for Occupational Safety and
Health. DHHS (NIOSH) Publication No. 2008-139.
---------------------------------------------------------------------------
Proposed Sec. 37.51(e) would require that quality control
procedures for devices used to display images for classification comply
with the recommendations of the American Association of Physicists in
Medicine, which are incorporated by reference. Further, this section
would require that if automatic quality assurance systems are used,
regular visual inspection also be performed using test patterns
recommended by the medical physicist. Periodic maintenance and
assessment of the display devices is essential to document that
performance continues to meet current professional recommendations.\30\
Because various automated systems may not detect all defects in digital
display devices (such as distortion, dropout of pixels, or surface
reflections), periodic visual inspections are also important to assure
the display performance is adequate.
---------------------------------------------------------------------------
\30\ Id.
---------------------------------------------------------------------------
Proposed Sec. 37.51(f) would establish that the classification of
digitally-acquired radiographs be based on the viewing of images
displayed as soft copies, and not as hard copy printed transparencies.
Further, proposed Sec. 37.51(g) would prohibit the use of digitized
copies of film-screen acquired images. There is currently no sufficient
scientific consensus regarding the equivalence of classifications
performed using either 1) hard copies of digitally-acquired images or
2) digitized versions of film-screen radiographs in comparison to
classifications performed using traditional film screen radiographic
methods. For this reason, classifications based upon these two
alternative approaches will not be accepted at this time.\31\
---------------------------------------------------------------------------
\31\ Samei E. Acquisition of digital chest images for
pneumoconiosis classification: Methods, procedures, and hardware.
In: NIOSH. Application of the ILO International Classification of
Radiographs of Pneumoconioses to Digital Chest Radiographic Images:
A NIOSH Scientific Workshop. Cincinnati, OH: U.S. Department of
Health and Human Services, Public Health Service, Centers for
Disease Control and Prevention, National Institute for Occupational
Safety and Health. DHHS (NIOSH) Publication No. 2008-139.
Franzblau A, Kazerooni EA, Sen A, Goodsitt MM, Lee SY, Rosenman
KD, Lockey JE, Meyer CA, Gillespie BW, Petsonk EL, Wang ML [2009].
Comparison of digital radiographs with film radiographs for the
classification of pneumoconiosis. Acad Radiol 16(6):669-677.
Suganuma N, Murata K, Kusaka Y [2008]. CR and FPD DR chest
radiographic image parameters for the pneumoconioses: The Japanese
approach and experience. In: NIOSH. Application of the ILO
International Classification of Radiographs of Pneumoconioses to
digital chest radiographic images: A NIOSH Scientific Workshop.
Cincinnati, OH: U.S. Department of Health and Human Services, Public
Health Service, Centers for Disease Control and Prevention, National
Institute for Occupational Safety and Health. DHHS (NIOSH)
Publication No. 2008-139.
Franzblau A, Kazerooni EA, Goodsitt M [2009]. Digital X-ray
imaging in pneumoconiosis screening: Future challenges for the NIOSH
B Reader Program. In: NIOSH. The NIOSH B Reader Certification
Program: Looking to the future. Cincinnati, OH: U.S. Department of
Health and Human Services, Public Health Service, Centers for
Disease Control and Prevention, National Institute for Occupational
Safety and Health. DHHS (NIOSH) Publication No. 2009-140.
---------------------------------------------------------------------------
Section 37.52 Proficiency in the Use of Systems for Classifying the
Pneumoconioses
Proposed Sec. 37.52(a) and (b), establishing the A and B Reader
approval programs, would be modified from existing Sec. 37.51 to make
clarifications in the current requirements and update older
terminology. Section 37.52(a)(3) would clarify that initial clinical
interpretations and notification of findings other than pneumoconiosis
under Sec. 37.51(a) must be provided by a qualified physician who has
all required licensure and privileges, and interprets chest radiographs
in the normal course of practice. Proposed Sec. 37.52(b)(1) would
retain the requirement under existing Sec. 37.51(b)(1) that B Reader
approval prior to October 1, 1976 be terminated.
Proposed Sec. 37.52(b)(2) would retain the requirement under
existing Sec. 37.51(b)(2) that physicians who desire to be B Readers
demonstrate their proficiency in evaluating chest radiographs by taking
an examination. The 6-hour initial certification examination was
commissioned by NIOSH and developed under a contract through the
American College of Radiology by the Department of Radiology and
Radiological Science, Johns Hopkins School of Medicine. The test has
been given about once a month by NIOSH since 1978. Beginning in 1984,
physicians who wish to maintain B reader status have been required to
pass a 3-hour recertification examination every 4 years. Examinees for
recertification who do not obtain a passing grade are permitted to take
the initial 6-hour certification examination at the next available
opportunity. Examinees who do not obtain a passing grade on the 6-hour
certification examination must wait 6 months before they are eligible
to sit again for the examination. The performance of the examination
has been described in two manuscripts published in the peer-reviewed
literature.\32\
---------------------------------------------------------------------------
\32\ Morgan RH. Proficiency examination of physicians for
classifying pneumoconiosis chest films. Am J Roentgenology
1979;132:803-08.
Wagner GR, Attfield MD, Kennedy RD, Parker JE. The NIOSH B
Reader Certification Program--An update report. Journal of
Occupational Medicine. 1992; 34:879-884.
---------------------------------------------------------------------------
The examination will be based on either film or digital images. The
existing provision would be modified to indicate that each physician
desiring to take the digital version of the B Reader examination will
be provided with a complete set of the NIOSH-approved digital standard
reference radiographs. NIOSH intends to offer both the film and digital
versions of the examination for a number of years. A satisfactory grade
in either examination will qualify the physician to interpret both
formats. NIOSH has not found that the format of the exam has any effect
on performance, and finds no justification for requiring that a
prospective B Reader take both versions of the exam. NIOSH welcomes
public comment on the potential benefits as well as the disadvantages
to requiring prospective readers to demonstrate competence in
classifying both film and digital images.
Finally, Sec. 37.52(c) would require that physicians who wish to
participate in the A and B Reader program familiarize themselves with
the necessary components for attainment of reliable classification of
chest radiographs for the pneumoconioses. The proposed requirement that
prospective A and B Readers review NIOSH guidance on radiographic
classification is included to ensure that each reader has studied
recommended classification methods
[[Page 1371]]
and approaches. The referenced NIOSH guidance document is newly-
developed and released; \33\ approval as an A or B Reader requires this
basic level of knowledge.
---------------------------------------------------------------------------
\33\ NIOSH [2011]. NIOSH Guideline: Application of Digital
Radiography for the Detection and Classification of Pneumoconiosis.
DHHS (NIOSH) Publication Number 2011-198. August 2011. http://www.cdc.gov/niosh/docs/2011-198/. Accessed November 16, 2011.
---------------------------------------------------------------------------
Records pertaining to the provisions in Sec. 37.52 are maintained
by NIOSH under CDC/ATSDR Privacy Act System of Records Notice 0920-
0001, Certifying Interpreting Physician File.
Section 37.53 Method of Obtaining Definitive Interpretations
Proposed Sec. 37.53 would maintain the standards in existing Sec.
37.52, which establishes that radiographs will be independently
interpreted by an A Reader and B Reader, or two B Readers, whose
classifications must be in agreement as defined in Sec. 37.53(b); if
sufficient agreement is lacking, NIOSH shall obtain a third
interpretation. Text added to Sec. 37.53(a) amends the existing
provision to clarify procedures in the event that independent
classifications from three B Readers do not demonstrate sufficient
agreement. In that case, the final determination would be based upon
the median (middle) classification of five interpretations derived from
the three initial readings plus two other classifications from B
Readers selected from the panel. This provision is intended to codify
the process used to resolve disagreements among three or more B
Readers. Text added to Sec. 37.53(b) would clarify that substantial
agreement is assessed by NIOSH after complete classifications are
received on either a paper or electronic version of the standard
Roentgenographic Interpretation Form (Form CDC/NIOSH (M)2.8).
Section 37.54 Notification of Abnormal Radiographic Findings
Proposed Sec. 37.54, redesignated from Sec. 37.53, would be
revised to update outdated terminology. The provision would also allow
the first reader to communicate certain information directly to the
miner, including abnormal findings other than pneumoconiosis. The
notification procedure is intended to facilitate and expedite the
process by which a miner is informed of potentially important medical
problems and could seek treatment.
Notification of important results to miners routinely occurs twice,
providing a particularly robust notification process. The first
notification is provided by the first physician to review a chest image
in the community, who is required to provide documentation of miner
notification to NIOSH. Subsequently, the image is sent to NIOSH and
reviewed by NIOSH B readers. Within 60 days of completion of the
physician readings, NIOSH will send a letter to each miner describing
all findings in layman's terminology, and recommending a specific
course of action appropriate to the findings. Current regulations
specify 60 days for receipt of the letters describing pneumoconiosis
and any other findings. From many years of experience, NIOSH has found
this time interval to be both appropriate and reasonable. Text for this
letter is standardized, and has been used by CWHSP for many years. A
booklet describing local medical and other resources and contact
information will be included with each letter.
Section 37.60 Submitting Required Chest Radiographs and Miner
Identification Documents
Proposed Sec. 37.60 would be essentially unchanged from existing
Sec. 37.60, which establishes the protocol for submitting radiographs.
Paragraph (a)(1) would also allow for the submission of image files for
digital radiographs, and permit the use of either hard copy or
electronic versions of the forms. We propose to strike the reference to
a pre-employment physical examination from paragraph (d) to be
consistent with the requirements of the Americans with Disabilities
Act.
Records pertaining to the provisions in Sec. 37.60 are maintained
by NIOSH under CDC/ATSDR Privacy Act System of Records Notice 0920-
0149, Morbidity Studies in Coal Mining, Metal and Non-Metal Mining and
General Industry.
Section 37.70 Review of Interpretations
This section would be amended only to update terminology. Proposed
Sec. 37.70(a) would retain the existing requirement that, in the
situation in which a mine plan provides an A reader to perform the
first reading of a miner's radiograph, a miner may request, and NIOSH
will obtain, an additional classification of his or her radiograph,
performed by a B reader. Proposed Sec. 37.70(b) would retain the
existing requirement that allows a mine operator who is directed by
MSHA to transfer a miner to a less dusty atmosphere based on a recent
examination to request that NIOSH review its findings. Terminology in
both (a) and (b) would be updated.
Section 37.80 Availability of Records for Radiographs
Proposed Sec. 37.80 would remain unchanged from the existing
requirement. Terminology in this section would be updated.
B. Subpart--Autopsies
Section 37.200 Scope
Proposed Sec. 37.200 would remain unchanged from the existing
explanation that provisions in this subpart establish conditions under
which pathologists will be paid to conduct autopsies on deceased
miners.
Section 37.201 Definitions
Proposed Sec. 37.201 would retain the existing definitions for
Secretary, miner, and pathologist, but would update ``ALFORD,'' in the
existing provision to ``NIOSH.''
Section 37.202 Payment for Autopsy
Proposed Sec. 37.202 would retain the existing provision setting
forth circumstances under which a pathologist may be paid by the
Secretary for performing an autopsy.
Section 37.203 Autopsy Specifications
Proposed Sec. 37.203 would retain the existing standards
establishing the manner in which autopsies are conducted.
Section 37.204 Procedure for Obtaining Payment
Proposed Sec. 37.204 would retain the existing procedure for
submitting a claim for payment to NIOSH (``NIOSH'' would be updated,
replacing ``ALFORD'').
IV. Regulatory Assessment Requirements
A. Executive Order 12866 and Executive Order 13563
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). E.O.
13563 emphasizes the importance of quantifying both costs and benefits,
of reducing costs, of harmonizing rules, and of promoting flexibility.
This proposed rule is being treated as a ``significant'' action
under E.O. 12866. It provides for the use of digital radiography
systems in the Coal Workers' Health Surveillance Program administered
by NIOSH under 42 CFR
[[Page 1372]]
part 37, in cooperation with coal mine operators, to monitor and
protect the health of U.S. coal miners, particularly for the prevention
of CWP. The current regulations at 42 CFR part 37 only allow for the
use of film-screen radiography systems in this program. The addition of
digital X-ray standards in part 37 would not require mine operators to
change their plans to accommodate digital radiographs, but it is
expected to substantially increase the amount of access miners will
have to radiograph facilities because the use of film-screen
radiography is declining markedly throughout the United States and
specifically in areas where coal mining is located and where coal
miners live. In fact, many clinics participating in the Program have
indicated that they are maintaining their outdated X-ray film
capabilities only because of Program requirements, and that they intend
to switch to digital radiography when NIOSH allows its use by
promulgating the rule proposed here. In general, most health care
facilities have abandoned the use of film-based X-rays. Mammography was
the last mainstream radiology procedure that required use of film; many
facilities made the final switch to digital several years ago when
digital mammography systems became available.
Increased access to radiograph facilities that offer digital X-rays
is expected to result in cost savings to coal miners because they will
not have to drive as far to visit a suitable clinic.
Digital radiographs are more cost-effective than their film-based
counterparts because they do not require costly chemical processing,
they eliminate the need for a separate device to develop the image, and
they avoid costs associated with managing and archiving hard-copy
images. Over the past 5 years approximately 100 clinics have submitted
film-screen radiographs to CWHSP. NIOSH queried several clinics on the
costs associated with film-screen radiography, including equipment
maintenance, chemicals, film, and processing. Based on the responses,
NIOSH believes that the cost to facilities of maintaining film X-ray
technology to provide radiographs for approximately 2,500 coal miners
is between $7,000 and $15,000 per clinic per year. Because NIOSH
expects that most facilities participating in the Program will switch
entirely to digital radiography when this rule is promulgated, we
estimate a one-time cost savings to facilities that currently provide
both film and digital radiographs of between $700,000 and $1,500,000
after they have discontinued the use of film radiographs. Although this
rule does not require any facility to upgrade to digital technology,
facilities that choose to do so will necessarily incur costs associated
with its acquisition. NIOSH invites public comment on these estimates.
The proposed rule would not require any radiography facility to
perform digital radiographs for this NIOSH program. Facilities may
continue to perform film-screen radiography under the current
requirements of Part 37 applicable to film-screen radiography, which
would not be substantially changed by this proposed rule.
The proposed provisions for using the DICOM standard and
incorporating by reference standard best practices for digital
radiography used in lung imaging ensure that the proposed requirements
reflect standard practice and technology. For these reasons, the rule
provisions allowing for the use of digital radiography and specifying
equipment and practice parameters would not impose any additional costs
on coal mine operators who provide for their miners' participation in
this program nor on the radiography facilities that serve the
participating coal miners.
The proposed rule would establish a new requirement for coal mine
operators to provide to NIOSH a roster of current miners as proposed
under Sec. 37.4(a)(3). The provision of this roster to NIOSH is
current practice by almost all of the approximately 500 U.S.
underground coal mine operators; therefore codifying this practice in
regulation will not result in any additional cost to mine operators.
For these reasons, the proposed rule is not considered economically
significant, as defined in Sec. 3(f)(1) of E.O. 12866.
The rule is consistent with the requirements of 42 U.S.C. 7384n(c).
The rule does not interfere with State, local, or tribal governments in
the exercise of their governmental functions.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq.,
requires each agency to consider the potential impact of its
regulations on small entities including small businesses, small
governmental units, and small not-for-profit organizations. This rule
would establish standards for the delivery of digitally-acquired chest
radiographs for underground coal miners. It would not impose any new
requirements on small radiographic facilities that participate in the
Coal Workers' Health Surveillance Program administered by NIOSH under
42 CFR part 37. These facilities may continue to exclusively use film-
screen technology for radiography under provisions that would be
essentially unchanged by this rulemaking. The rule would benefit these
facilities by allowing and facilitating their transition to digital
radiography for the purposes of this program. In this respect, the
reliance in the proposal on the DICOM standards, standard technology,
and current best practices for lung imaging radiography ensure that the
rule is consistent with current medical practices in digital
radiography. It should also be noted that if this standard permits some
facilities to switch entirely to digital imaging, rather than
maintaining two duplicate technologies, the facilities may be able to
achieve savings in radiography operating costs, as discussed in the
Executive Orders 12866 and 13563 analysis above. The proposed standard
would also introduce a substantial benefit in allowing the
participation in the program of radiography facilities that solely use
digital radiography; such facilities currently are prohibited from
participation due to the current lack of digital radiography standards
for the program under part 37.
This proposed rule should increase access to medical facilities for
small and larger coal mine operators, since many medical facilities
exclusively use digital radiography or are transitioning to this
technology. The rule may also decrease the cost to coal mine operators
of providing X-ray screenings to miners. Lower cost is likely to be one
of the factors in the trend among radiography facilities to adopt or
switch entirely to digital radiography. In any event, allowing and
facilitating the provision of digital radiography under part 37 would
impose no new costs on small coal mine operators.
The proposed rule would establish a new requirement for coal mine
operators to provide to NIOSH a roster of current miners as proposed
under Sec. 37.4(a)(3). The provision of this roster to NIOSH is
current practice by almost all coal mine operators. NIOSH estimates
that, of 488 underground coal mines that can be considered small as of
the first quarter of 2011,\34\ 130 coal mine plans are submitted to the
Agency annually. NIOSH further estimates that a clerical worker spends
0.5 hours per year preparing the roster. According to the Bureau of
Labor Statistics, the average salary of a coal mine clerical worker is
$17.38/hour; NIOSH estimates the annual cost for an individual coal
[[Page 1373]]
mine operator to supply a roster to NIOSH is approximately $9 and the
total cost to all coal mines combined amounts to approximately $1170
annually. In NIOSH's judgment, this $9 cost would not be significant
for any coal mine operator. Therefore, a regulatory flexibility
analysis as provided for under the RFA is not required. NIOSH certifies
that this rule will not have a significant economic impact on a
substantial number of small entities within the meaning of the RFA.
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\34\ U.S. Department of Labor, Mine Safety and Health
Administration. Mining Industry Accident, Injuries, Employment, and
Production Data--Address & Employment Self-Extracting Files. http://www.msha.gov/stats/part50/p50y2k/aetable.htm. Accessed July 7, 2011.
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C. Paperwork Reduction Act
The Paperwork Reduction Act, 44 U.S.C. 3501 et seq., requires an
agency to invite public comment on, and to obtain OMB approval of, any
regulation that requires 10 or more people to report information to the
agency or to keep certain records. This proposed rule continues to
impose the same information collection requirements as under the
current rule, including the submission of the following forms:
Roentgenographic Interpretation Form [CDC/NIOSH (M)2.8]
Miner Identification Document [CDC/NIOSH (M)2.9]
Coal Mine Operator's Plan [CDC/NIOSH (M)2.10]
Facility Certification Document [CDC/NIOSH (M)2.11]
Interpreting Physician Certification Document [CDC/NIOSH
(M)2.12]
Consent, Release, and History Form [CDC/NIOSH (M)2.6]
These forms are approved by OMB for data collected under the CWHSP
(OMB Control No. 0920-0020, exp. June 30, 2014).
The additional reporting burden associated with the Coal Mine
Operator's Plan which would require underground coal mine operators to
submit a roster of current employees (Sec. 37.4(a)(3)), and the
Facility Certification Document which would be required of
participating digital radiography facilities (Sec. 37.44(a)(2)), are
both accounted for in the OMB information collection approval
referenced above. There is no additional recordkeeping burden
associated with the quality assurance program referenced in Sec.
37.44(g) because this provision reflects standard industry practice and
does not impose any new recordkeeping requirements.
----------------------------------------------------------------------------------------------------------------
Number of Response
Type of respondent Form name and Number of responses per Hours/ burden (in
No. respondents respondent response hrs)
----------------------------------------------------------------------------------------------------------------
Physicians (B Readers)........ Roentgenographic 10,000 1 3/60 500
Interpretation
Form--CDC/NIOSH
(M) 2.8.
Miners........................ Miner 5,000 1 20/60 1,667
Identification
Document--CDC/
NIOSH (M) 2.9.
Coal Mine Operators........... Coal Mine 200 1 30/60 100
Operator's
Plan--CDC/NIOSH
(M) 2.10.
Supervisors at X-ray Facility 100 1 30/60 50
Facilities. Certification
Document--CDC/
NIOSH (M) 2.11.
Physicians (B Readers)........ Interpreting 300 1 10/60 50
Physician
Certification
Document--CDC/
NIOSH (M) 2.12.
Spirometry Test--Coal Miners.. No form involved 2,500 1 20/60 833
X-ray--Coal Miners............ No form involved 5,000 1 15/60 1250
Pathologist................... (Invoice)....... 50 1 5/60 4
Pathologist................... (Final 50 1 5/60 4
diagnosis).
Next-of-Kin................... Consent, 50 1 15/60 13
Release, and
History Form--
CDC.NIOSH (M)
2.6.
---------------------------------------------------------------
Totals.................... ................ 23,250 .............. .............. 4,471
----------------------------------------------------------------------------------------------------------------
D. Small Business Regulatory Enforcement Fairness Act
As required by Congress under the Small Business Regulatory
Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), the Department
will report the promulgation of this rule to Congress prior to its
effective date. The report will state that the Department has concluded
that this rule is not a ``major rule'' because it is not likely to
result in an annual effect on the economy of $100 million or more.
E. Unfunded Mandates Reform Act of 1995
Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531
et seq.) directs agencies to assess the effects of Federal regulatory
actions on State, local, and tribal governments, and the private sector
``other than to the extent that such regulations incorporate
requirements specifically set forth in law.'' For purposes of the
Unfunded Mandates Reform Act, this rule does not include any Federal
mandate that may result in increased annual expenditures in excess of
$100 million by State, local or tribal governments in the aggregate, or
by the private sector.
F. Executive Order 12988 (Civil Justice)
This rule has been drafted and reviewed in accordance with
Executive Order 12988, ``Civil Justice Reform,'' and will not unduly
burden the Federal court system. Chest radiograph interpretations that
result in a finding of pneumoconiosis may be an element in claim
processing and adjudication conducted by DOL's Black Lung Compensation
Program. This proposed rule would affect radiographs submitted to DOL
for the purpose of reviewing and administering those claims. This rule
has been reviewed carefully to eliminate drafting errors and
ambiguities.
G. Executive Order 13132 (Federalism)
The Department has reviewed this rule in accordance with Executive
Order 13132 regarding federalism, and has determined that it does not
have ``federalism implications.'' The rule does not ``have substantial
direct effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
H. Executive Order 13045 (Protection of Children From Environmental
Health Risks and Safety Risks)
In accordance with Executive Order 13045, HHS has evaluated the
environmental health and safety effects of this rule on children. HHS
has determined that the rule would have no effect on children.
[[Page 1374]]
I. Executive Order 13211 (Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use)
In accordance with Executive Order 13211, HHS has evaluated the
effects of this rule on energy supply, distribution or use, and has
determined that the rule will not have a significant adverse effect.
J. Plain Writing Act of 2010
Under Public Law 111-274 (October 13, 2010), executive Departments
and Agencies are required to use plain language in documents that
explain to the public how to comply with a requirement the Federal
Government administers or enforces. HHS has attempted to use plain
language in promulgating the proposed rule consistent with the Federal
Plain Writing Act guidelines.
V. Proposed Rule
List of Subjects in 42 CFR Part 37
Black lung benefits, Incorporation by reference, Lung diseases,
Mine safety and health, Occupational safety and health, Pneumoconiosis,
Respiratory and pulmonary diseases, Underground coal mining, Workers'
compensation, X-rays.
Text of the Rule
For the reasons discussed in the preamble, the Department of Health
and Human Services proposes to amend 42 CFR part 37 as follows:
PART 37--SPECIFICATIONS FOR MEDICAL EXAMINATIONS OF UNDERGROUND
COAL MINERS
1. The authority citation for part 37 continues to read as follows:
Authority: Sec. 203, 83 Stat. 763 (30 U.S.C. 843), unless
otherwise noted.
Subpart--Chest Radiographic Examinations
2. Revise Sec. 37.1 to read as follows:
Sec. 37.1 Scope.
The provisions of this subpart set forth the specifications for
giving, interpreting, classifying, and submitting chest radiographs
required by section 203 of the Act to be given to underground coal
miners and new miners.
3. Revise Sec. 37.2 to read as follows:
Sec. 37.2 Definitions.
Any term defined in the Federal Mine Safety and Health Act of 1977
and not defined below shall have the meaning given it in the Act. As
used in this subpart:
Act means the Federal Mine Safety and Health Act of 1977 (30 U.S.C.
801, et seq.).
Chest radiograph means a single posteroanterior radiographic
projection or radiograph of the chest at full inspiration recorded on
either film or digital radiography systems.
Convenient time and place with respect to the conduct of any
examination under this subpart means that the examination must be given
at a reasonable hour in the locality in which the miner resides or a
location that is equally accessible to the miner. For example,
examinations at the mine during, immediately preceding, or immediately
following work and a ``no appointment'' examination at a medical
facility in a community easily accessible to the residences of a
majority of the miners working at the mine, shall be considered of
equivalent convenience for purposes of this paragraph.
Digital radiography systems, as used in this context, include both
Digital Radiography (DR) and Computed Radiography (CR).
(1) Computed radiography (CR) is the term for digital X-ray image
acquisition systems that detect X-ray signals using a cassette-based
photostimulable storage phosphor. Subsequently, the cassette is
processed using a stimulating laser beam to convert the latent
radiographic image to electronic signals which are then processed and
stored so they can be displayed.
(2) Digital radiography (DR) is the term used for digital X-ray
image acquisition systems in which the X-ray signals received by the
image detector are converted nearly instantaneously to electronic
signals without movable cassettes.
ILO Classification means the below-referenced classification of
radiographs of the pneumoconioses system devised by an international
committee of the International Labour Office (ILO), including a
complete set of standard film radiographs or digital chest image files
available from the ILO or other set of chest image files accepted by
NIOSH as equivalent.
MSHA means the Mine Safety and Health Administration, Department of
Labor.
Miner means any individual including any coal mine construction
worker who is working in or at any underground coal mine, but does not
include any surface worker who does not have direct contact with
underground coal mining or with coal processing operations.
NIOSH means the National Institute for Occupational Safety and
Health (NIOSH), located within the Centers for Disease Control and
Prevention (CDC). Within NIOSH, the Division of Respiratory Disease
Studies (DRDS), Box 4258, Morgantown, WV 26504, formerly called the
Appalachian Laboratory for Occupational Safety and Health, is the
organizational unit that has programmatic responsibility for the chest
radiographic examination program.
NIOSH representative means employees of CDC/NIOSH and employees of
CDC contractors.
Operator means any owner, lessee, or other person who operates,
controls, or supervises an underground coal mine or any independent
contractor performing services or construction at such mine.
Panel of B Readers means the group of physicians that are currently
approved by NIOSH as B Readers.
Pre-placement physical examination means any medical examination
which includes a chest radiographic examination given in accordance
with the specifications of this Part to a person not previously
employed by the same operator. Such examinations should be conducted
consistent with applicable law, including the Americans with
Disabilities Act of 1990, which provides that pre-placement
examinations take place only after an offer of employment has been made
and subject to certain restrictions (42 U.S.C. 12112(d)).
Qualified medical physicist means an individual who is trained in
evaluating the performance of radiographic equipment including
radiation controls and facility quality assurance programs, and has the
relevant current certification by a competent U.S. national board, or
unrestricted license or approval from a U.S. state or territory.
Radiographic technique chart means a table which specifies the
types of cassette, intensifying screen, film or digital detector, grid,
filter, and lists X-ray machine settings (timing, kVp, mA) that enables
the radiographer to select the correct settings based on the body
habitus or the thickness of the chest tissue.
Radiologic technologist means an individual who has met the
requirements for privileges to perform general radiographic procedures
and for competence in using the equipment and software employed by the
examining facility to obtain chest images as specified by the state or
territory and examining facility in which such services are provided.
Optimally, such an individual will have completed a formal training
program in radiography leading to a certificate, an associate degree,
or a bachelor's degree and participated in the voluntary initial
certification and annual renewal of
[[Page 1375]]
registration for radiologic technologists offered by the American
Registry of Radiologic Technologists.
Secretary means the Secretary of Health and Human Services and any
other officer or employee of the Department of Health and Human
Services to whom the authority involved may be delegated.
Soft copy means the image of a coal miner's chest radiograph
acquired using a digital radiography system, viewed at the full
resolution of the image acquisition system using an electronic medical
image display device.
4. Revise Sec. 37.3 to read as follows:
Sec. 37.3 Chest radiographs required for miners.
(a) Voluntary examinations. Every operator shall provide to each
miner who is employed in or at any of its underground coal mines and
who was employed in underground coal mining prior to December 30, 1969,
or who has completed the required examinations under Sec. 37.3(b) an
opportunity for a chest radiograph in accordance with this subpart:
(1) Following August 1, 1978 NIOSH will notify the operator of each
underground coal mine of a period within which the operator may provide
examinations to each miner employed at its coal mine. The period shall
begin no sooner than the effective date of these regulations and end no
later than a date specified by NIOSH separately for each coal mine. The
termination date of the period will be approximately 5 years from the
date of the first examination which was made on a miner employed by the
operator in its coal mine under the former regulations of this subpart
adopted July 27, 1973. Within the period specified by NIOSH for each
mine, the operator may select a 6-month period within which to provide
examinations in accordance with a plan approved under Sec. 37.5.
Example: NIOSH finds that between July 27, 1973, and March 31,
1975, the first radiograph for a miner who was employed at mine Y
and who was employed in underground coal mining prior to December
30, 1969, was made on January 1, 1974. NIOSH will notify the
operator of mine Y that the operator may select and designate on its
plan a 6-month period within which to offer its examinations to its
miners employed at mine Y. The 6-month period shall be scheduled
between August 1, 1978 and January 1, 1979 (5 years after January 1,
1974).
(2) For all future voluntary examinations, NIOSH will notify the
operator of each underground coal mine when sufficient time has elapsed
since the end of the previous 6-month period of examinations. NIOSH
will specify to the operator of each mine a period within which the
operator may provide examinations to its miners employed at its coal
mine. The period shall begin no sooner than 3\1/2\ years and end no
later than 4\1/2\ years subsequent to the ending date of the previous
6-month period specified for a coal mine either by the operator on an
approved plan or by NIOSH if the operator did not submit an approved
plan. Within the period specified by NIOSH for each mine, the operator
may select a 6-month period within which to provide examinations in
accordance with a plan approved under Sec. 37.5.
Example: NIOSH finds that examinations were previously provided
to miners employed at mine Y in a 6-month period from July 1, 1979,
to December 31, 1979. NIOSH notifies the operator at least 3 months
before July 1, 1983 (3\1/2\ years after December 31, 1979) that the
operator may select and designate on its plan the next 6-month
period within which to offer examinations to its miners employed at
mine Y. The 6-month period shall be scheduled between July 1, 1983,
and July 1, 1984 (between 3\1/2\ and 4\1/2\ years after December 31,
1979).
(3) Within either the next or future period(s) specified by NIOSH
to the operator for each of its coal mines, the operator of the coal
mine may select a different 6-month period for each of its mines within
which to offer examinations. In the event the operator does not submit
an approved plan, NIOSH will specify a 6-month period to the operator
within which miners shall have the opportunity for examinations.
(b) Mandatory examinations. Every operator shall provide to each
miner who begins working in or at a coal mine for the first time after
December 30, 1969:
(1) An initial chest radiograph, as soon as possible, but in no
event later than 6 months after commencement of employment. An initial
chest radiograph given to a miner according to former regulations for
this subpart prior to August 1, 1978 will also be considered as
fulfilling this requirement.
(2) A second chest radiograph, in accordance with this subpart, 3
years following the initial examination if the miner is still engaged
in underground coal mining. A second radiograph given to a miner
according to former regulations under this subpart prior to August 1,
1978 will be considered as fulfilling this requirement.
(3) A third chest radiograph 2 years following the second chest
radiograph if the miner is still engaged in underground coal mining and
if the second radiograph shows evidence of category 1 (1/0, 1/1, 1/2),
category 2 (2/1, 2/2, 2/3), category 3 (3/2, 3/3, 3/+) simple
pneumoconioses, or complicated pneumoconioses (ILO Classification).
(c) NIOSH will notify the miner when he or she is due to receive
the second or third mandatory examination under (b) of this section.
Similarly, NIOSH will notify the coal mine operator when the miner is
to be given a second examination. The operator will be notified
concerning a miner's third examination only with the miner's written
consent, and the notice to the operator shall not state the medical
reason for the examination nor that it is the third examination in the
series. If the miner is notified by NIOSH that the third mandatory
examination is due and the operator is not so notified, availability of
the radiographic examination under the Coal Mine Operator's Plan (Form
CDC/NIOSH (M)2.10) shall constitute the operator's compliance with the
requirement to provide a third mandatory examination even if the miner
refuses to take the examination.
(d) The opportunity for chest radiographs to be available by an
operator for purposes of this subpart shall be provided in accordance
with a plan which has been submitted and approved in accordance with
this subpart.
5. Amend Sec. 37.4 by revising paragraphs (a) introductory text,
(a)(3), (a)(4), (a)(6), (a)(7), and (d) through (f) to read as follows:
Sec. 37.4 Plans for chest radiographic examinations.
(a) Every plan for chest radiographic examinations of miners shall
be submitted on the Coal Mine Operator's Plan form (Form CDC/NIOSH
(M)2.10) to NIOSH within 120 calendar days after August 1, 1978. In the
case of a person who after August 1, 1978, becomes an operator of a
mine for which no plan has been approved, that person shall submit a
plan within 60 days after such event occurs. A separate plan shall be
submitted by the operator and by each construction contractor for each
underground coal mine which has a MSHA identification number. The plan
shall include:
* * * * *
(3) The proposed beginning and ending date of the 6-month period
for voluntary examinations (see Sec. 37.3(a)), the estimated number of
miners to be given or offered examinations during the 6-month period
under the plan, and a roster specifying the names and current home
mailing addresses of each miner covered by the plan;
(4) The name and location of the approved X-ray facility or
facilities, and
[[Page 1376]]
the approximate date(s) and time(s) of day during which the radiographs
will be given to miners to enable a determination of whether the
examinations will be conducted at a convenient time and place;
* * * * *
(6) The name and address of the A or B Reader who will interpret
and classify the chest radiographs. In the event a plan lists an
approved facility with a digital radiography system, the name and
address of the physician(s) who will perform the initial clinical
interpretation.
(7) Assurances that:
(i) The operator will not solicit a physician's radiographic or
other findings concerning any miner employed by the operator,
(ii) Instructions have been given to the person(s) giving the
examinations that duplicate radiographs or copies of radiographs
(including, for digital radiographs, copies of electronic files) will
not be made, and to the extent that it is technically feasible for the
imaging system used, digital radiographs and all related digital files
shall be permanently deleted from the facility records or rendered
permanently inaccessible following the confirmed transfer of such data
to NIOSH, and that (except as may be necessary for the purpose of this
subpart) the physician's radiographic and other findings, as well as
the occupational history information obtained from a miner will not be
disclosed in a manner that would permit identification of the
individual with their information, and
(iii) The radiographic examinations will be made at no charge to
the miner.
* * * * *
(d) The operator shall advise NIOSH of any change in its plan. Each
change in an approved plan is subject to the same review and approval
as the originally approved plan.
(e) The operator shall promptly display in a visible location on
the bulletin board at the mine its proposed plan or proposed change in
plan when it is submitted to NIOSH. The proposed plan or change in plan
shall remain posted in a visible location on the bulletin board until
NIOSH either grants or denies approval of it at which time the approved
plan or denial of approval shall be permanently posted. In the case of
an operator who is a construction contractor and who does not have a
bulletin board, the construction contractor must otherwise notify its
employees of the examination arrangements. Upon request, the contractor
must show NIOSH written evidence that its employees have been notified.
(f) Upon notification from NIOSH that sufficient time has elapsed
since the previous period of examinations, the operator will resubmit
its plan for each of its coal mines to NIOSH for approval for the next
period of examinations (see Sec. 37.3(a)(2)). The plan shall include
the proposed beginning and ending dates of the next period of
examinations and all information required by paragraph (a) of this
section.
6. Revise Sec. 37.5 to read as follows:
Sec. 37.5 Approval of plans.
(a) If, after review of any plan submitted pursuant to this
subpart, the Secretary determines that the action to be taken under the
plan by the operator meets the specifications of this subpart and will
effectively achieve its purpose, the Secretary will approve the plan
and notify the operator(s) submitting the plan of the approval.
Approval may be conditioned upon such terms as the Secretary deems
necessary to carry out the purpose of section 203 of the Act.
(b) Where the Secretary has reason to believe that he or she will
deny approval of a plan the Secretary will, prior to the denial, give
reasonable notice in writing to the operator(s) of an opportunity to
amend the plan. The notice shall specify the ground upon which approval
is proposed to be denied.
(c) If a plan is denied approval, the Secretary shall advise the
operator(s) in writing of the reasons for the denial.
7. Amend Sec. 37.6 by revising paragraphs (a) and (d) to read as
follows:
Sec. 37.6 Chest radiographic examinations conducted by the Secretary.
(a) The Secretary will give chest radiographs or make arrangements
with an appropriate person, agency, or institution to give the chest
radiographs and with A or B Readers to interpret the radiographs
required under this subpart in the locality where the miner resides, at
the mine, or at a medical facility easily accessible to a mining
community or mining communities, under the following circumstances:
* * * * *
(d) Operators of mines selected by NIOSH to participate in the
National Study of Coal Workers' Pneumoconiosis (an epidemiological
study of respiratory diseases in coal miners) and who agree to
cooperate will have all their miners afforded the opportunity to have a
chest radiograph required hereunder at no cost to the operator. For
future examinations and for mandatory examinations each participating
operator shall submit an approvable plan.
8. Amend Sec. 37.7 by revising paragraph (a) to read as follows:
Sec. 37.7 Transfer of affected miner to less dusty area.
(a) Any miner who, in the judgment of the Secretary based upon the
interpretation of one or more of the miner's chest radiographs, shows
category 1 (1/0, 1/1, 1/2), category 2 (2/1, 2/2, 2/3), or category 3
(3/2, 3/3, 3/+) simple pneumoconioses, or complicated pneumoconioses
(ILO Classification) shall be afforded the option of transferring from
his or her position to another position in an area of the mine where
the concentration of respirable dust in the mine atmosphere is not more
than 50 percent of the maximum respirable dust concentration permitted
by MSHA, or if such level is not attainable in the mine, to a position
in the mine where the concentration of respirable dust is the lowest
attainable below the maximum respirable dust concentration permitted by
MSHA.
* * * * *
9. Revise Sec. 37.8 to read as follows:
Sec. 37.8 Radiographic examination at miner's expense.
Any miner who wishes to obtain an examination at the miner's own
expense at an approved facility and to have the complete examination
submitted to NIOSH may do so, provided that the examination is made no
sooner than 6 months after the most recent examination of the miner
submitted to NIOSH. NIOSH will provide an interpretation and report of
the examinations made at the miner's expense in the same manner as if
it were submitted under an operator's plan. Any change in the miner's
transfer rights under the act which may result from this examination
will be subject to the terms of Sec. 37.7.
10. Revise Sec. 37.20 to read as follows:
Sec. 37.20 Miner identification document.
As part of the radiographic examination, a Miner Identification
Document (Form CDC/NIOSH (M)2.9) which includes an occupational history
questionnaire shall be completed for each miner at the facility where
the radiograph is made at the same time the chest radiograph required
by this subpart is given.
11. Revise the undesignated center heading and Sec. 37.40 to read
as follows:
[[Page 1377]]
Specifications for Performing Chest Radiographic Examinations
Sec. 37.40 General provisions.
(a) The chest radiographic examination shall be given at a
convenient time and place.
(b) The chest radiographic examination consists of the chest
radiograph, and a complete Roentgenographic Interpretation Form (Form
CDC/NIOSH (M)2.8), and Miner Identification Document (Form CDC/NIOSH
(M)2.9).
(c) A radiographic examination shall be made in a facility approved
in accordance with Sec. 37.43 or Sec. 37.44 by or under the
supervision of a physician who makes chest radiographs in the normal
course of practice and who has demonstrated ability to make chest
radiographs of a quality to best ascertain the presence of
pneumoconiosis.
12. Amend Sec. 37.41 as follows:
a. Revise the section heading.
b. Redesignate paragraphs (a) and (b) as paragraphs (b) and (a)
respectively.
c. Redesignate paragraphs (c) through (m) as (d) through (n).
d. Add new paragraph (c).
e. Revise newly designated paragraphs (a), (b), (d) through (h),
(i) introductory text, (i)(1) through (i)(3), (i)(7), (j)(2), (k), (m),
and (n) to read as follows:
Sec. 37.41 Chest radiograph specifications--film.
(a) Miners shall be disrobed from the waist up at the time the
radiograph is given. The facility shall provide a dressing area and for
those miners who wish to use one, the facility shall provide a clean
gown. Facilities shall be heated to a comfortable temperature.
(b) Every chest radiograph shall be a single posteroanterior
projection at full inspiration on a film being no less than 14 by 17
inches and no greater than 16 by 17 inches. The film and cassette shall
be capable of being positioned both vertically and horizontally so that
the chest radiograph will include both apices and costophrenic angles.
If a miner is too large to permit the above requirements, then the
projection shall include both apices with minimum loss of the
costophrenic angle.
(c) Chest radiographs shall be performed by a radiologic
technologist.
(d) Radiographs shall be made only with a diagnostic X-ray machine
having a rotating anode tube with a maximum of a 2 mm source (focal
spot).
(e) Except as provided in paragraph (e) of this section,
radiographs shall be made with units having generators which comply
with the following:
(1) The generators of existing radiographic units acquired by the
examining facility prior to July 27, 1973, shall have a minimum rating
of 200 mA at 100 kVp;
(2) Generators of units acquired subsequent to that date shall have
a minimum rating of 300 mA at 125 kVp.
(f) Radiographs made with battery-powered mobile or portable
equipment shall be made with units having a minimum rating of 100 mA at
110 kVp at 500 Hz, or of 200 mA at 110 kVp at 60 Hz.
(g) Capacitor discharge and field emission units may be used if the
model of such units is approved by NIOSH for quality, performance, and
safety. NIOSH will consider such units for approval when listed by a
facility seeking approval under Sec. 37.43 or Sec. 37.44 of this
subpart.
(h) Radiographs shall be given only with equipment having a beam-
limiting device which does not cause large unexposed boundaries. The
beam limiting device shall provide rectangular collimation and shall be
of the type described in 21 CFR 1020.31(d), (e), (f), and (g). The use
of such a device shall be discernible from an examination of the
radiograph.
(i) To ensure high quality chest radiographs:
(1) The maximum exposure time shall not exceed 50 milliseconds
except that with single phase units with a rating less than 300 mA at
125 kVp and subjects with chests over 28 cm posteroanterior, the
exposure may be increased to not more than 100 milliseconds;
(2) The source or focal spot to film distance shall be at least 6
feet;
(3) Medium speed film and medium speed intensifying screens are
recommended. However, any film-screen combination, the rated ``speed''
of which is at least 100 and does not exceed 300, which produces
radiographs with spatial resolution, contrast, latitude and quantum
mottle similar to those of systems designated as ``medium speed'' may
be employed;
* * * * *
(7) A suitable grid or other means of reducing scattered radiation
shall be used;
* * * * *
(j) * * *
(2) If mineral or other impurities in the processing water
introduce difficulty in obtaining a high-quality radiograph, a suitable
filter or purification system shall be used.
(k) Before the miner is advised that the examination is concluded,
the radiograph shall be processed and inspected and accepted for
quality by the physician, or if the physician is not available,
acceptance may be made by the radiologic technologist. In a case of a
substandard radiograph, another shall be immediately made. All
substandard radiographs shall be clearly marked as rejected and
promptly sent to NIOSH for disposal.
* * * * *
(m) A test object may be required on each radiograph for an
objective evaluation of film quality at the discretion of NIOSH.
(n) Each radiograph made hereunder shall be permanently and legibly
marked with the name and address or NIOSH approval number of the
facility at which it is made, the social security number of the miner,
and the date of the radiograph. No other identifying markings shall be
recorded on the radiograph.
Sec. Sec. 37.42 and 37.43 [Redesignated]
13a. Redesignate Sec. Sec. 37.42 and 37.43 as Sec. Sec. 37.43 and
37.45 respectively.
13b. Add new Sec. 37.42 to read as follows:
Sec. 37.42 Chest radiograph specifications--digital radiography
systems.
(a) Miners shall be disrobed from the waist up at the time the
radiograph is given. The facility shall provide a private dressing area
and for those miners who wish to use one, the facility shall provide a
clean gown. Facilities shall be heated to a comfortable temperature.
(b) Every digital chest radiograph taken as required under this
regulation shall be a single posteroanterior projection at full
inspiration on a digital detector being no less than 35 by 43 cm (14 by
17 if measured in inches) and no greater than 41 by 43 cm (16 by 17
inches). The imaging plate shall have a maximum pixel pitch of
200[mu]m, and a minimum matrix size of 5 megapixels (for 35 by 43 cm),
with a minimum bit depth of 10. Spatial resolution shall be at least
2.5 line pairs per millimeter. The storage phosphor cassette or digital
image detector shall be positioned either vertically or horizontally so
that the image includes the apices and costophrenic angles of both
right and left lungs. If the detector cannot include the apices and
costophrenic angles of both lungs as described, then two side by side
images can be obtained which together include the apices and the
costophrenic angles of both right and left lungs.
(c) Chest radiographs shall be given by a radiologic technologist.
(d) Radiographs shall be made with a diagnostic X-ray machine with
a maximum of a 2 mm source (focal spot).
[[Page 1378]]
(e) Radiographs shall be made with units having generators which
have a minimum rating of 300 mA at 125 kVp. Exposure kilovoltage shall
be at least the minimum as recommended by the manufacturer for chest
radiography.
(f) An electric power supply shall be used which complies with the
voltage, current, and regulation specified by the manufacturer of the
machine. If the manufacturer or installer of the radiographic equipment
recommends equipment for control of electrical power fluctuations, such
equipment shall be used as recommended.
(g) Radiographs shall be obtained only with equipment having a
beam-limiting device that does not cause large unexposed boundaries.
The beam limiting device shall provide rectangular collimation.
Electronic post-image acquisition ``shutters'' available on some CR and
DR systems that limit the size of the final image and that simulate
collimator limits shall not be used. The use and effect of the beam
limiting device shall be discernible on the resulting image.
(h) Radiographic technique charts shall be used that are developed
specifically for the X-ray system and detector combinations used,
indicating exposure parameters by anatomic measurements.
(1) If automated exposure control devices are used, performance
shall be documented by a medical physicist utilizing the image capture
systems and exposure parameters used at the facility for chest imaging,
using methods recommended by the American Association of Physicists in
Medicine in AAPM Report No. 74, Quality Control in Diagnostic
Radiology, Report of Task Group 12, Diagnostic X-Ray Imaging
Committee, published by Medical Physics Publishing for AAPM, July 2002,
pages 17-18, and in AAPM Report No. 14, Performance Specifications and
Acceptance Testing for X-Ray Generators and Automatic Exposure Control
Devices, Report of the Diagnostic X-Ray Imaging Committee Task Group on
Performance Specifications and Acceptance Testing for X-Ray Generators
and Automatic Exposure Control Devices, published by the American
Institute of Physics for AAPM, January 1985, pages 61-62. These reports
are incorporated by reference. The Director of the Federal Register
approves this incorporation by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may obtain a copy of AAPM Report No. 74
from the AAPM Web site at http://www.aapm.org/pubs/reports/rpt_74.pdf
or from Medical Physics Publishing, 4513 Vernon Blvd., Madison, WI
53705. You may obtain a copy of AAPM Report No. 14 from http://www.aapm.org/pubs/reports/rpt_14.pdf or from AAPM, 335 E. 45 Street,
New York, NY 10017. You may inspect a copy of AAPM Report No. 74 or
AAPM Report No. 14 at the NIOSH Docket Office, Robert A. Taft
Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226, or
at the National Archives and Records Administration (NARA). For
information on the availability of these materials at NARA, call (202)
741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(2) Exposure parameters achieved during the evaluation of the
automated exposure system shall be recorded by the medical physicist in
a written report or electronic file that is stored at the facility and
available for inspection by NIOSH for a minimum of 5 years after the
miner's examination.
(i) To ensure high quality digital chest radiographs:
(1) The maximum exposure time shall not exceed 50 milliseconds
except for subjects with chests over 28 centimeters posteroanterior,
for whom the exposure time shall not exceed 100 milliseconds;
(2) The distance from source or focal spot to detector shall be at
least 70 inches (or 180 centimeters if measured in centimeters);
(3) The exposure setting for chest images shall be within the range
of 100-300 equivalent exposure speeds and shall comply with the
American College of Radiology (ACR) Practice Guideline For Diagnostic
Reference Levels in Medical X-Ray Imaging, Section V--Diagnostic
Reference Levels For Imaging With Ionizing Radiation and Section VII--
Radiation Safety in Imaging, Revised 2008 (Res. 3). The ACR Practice
Guideline is incorporated by reference. The Director of the Federal
Register approves this incorporation by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy of the ACR
Practice Guideline from the ACR Web site at http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/med_phys/reference_levels.aspx. You may inspect a copy of the ACR Practice
Guideline at the NIOSH Docket Office, Robert A. Taft Laboratories, MS-
C34, 4676 Columbia Parkway, Cincinnati, OH 45226, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call (202) 741-6030 or go to
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Radiation exposures should be
periodically measured and patient radiation doses estimated by the
medical physicist to assure doses are as low as reasonably achievable.
(4) Digital radiography system performance, including image signal-
to-noise and detective quantum efficiency shall be evaluated and judged
acceptable by a qualified medical physicist using the specifications of
the American Association of Physicists in Medicine, AAPM Report No. 93,
Acceptance Testing and Quality Control of Photostimulable Storage
Phosphor Imaging Systems, Report of AAPM Task Group 10, published by
AAPM, October 2006, pages 1-68. This report is incorporated by
reference. The Director of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain a copy of AAPM Report No. 93 from the AAPM Web
site at http://www.aapm.org/pubs/reports/RPT_93.pdf or from AAPM, One
Physics Ellipse, College Park, MD 20740. You may inspect a copy of AAPM
Report No. 93 at the NIOSH Docket Office, Robert A. Taft Laboratories,
MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226, or at the National
Archives and Records Administration (NARA). For information on the
availability of these materials at NARA, call (202) 741-6030 or go to
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Image management software and settings
for routine chest imaging shall be used, including routine
amplification of digital detector signal as well as standard image
post-processing functions. No image or edge enhancement software
functions shall be employed unless they are integral to the digital
radiography system (not elective); in such cases, only the minimum
image enhancement permitted by the system shall be employed.
(5) (i) The image object, transmission and associated data storage,
file format, and transmission of associated information shall conform
to the following components of the National Electrical Manufacturers
Association's Digital Imaging and Communications in Medicine (DICOM)
standard:
(A) Part 3 (PS 3.3-2011): Information Object Definitions, Annex A--
Composite Information Object Definitions, sections: Digital X-Ray Image
Information Object Definition; X-Ray Radiation Dose SR Information
Object Definition; and Grayscale Softcopy Presentation State
Information Object Definition.
[[Page 1379]]
(B) Part 4 (PS3.4-2011): Service Class Specifications, sections:
Annex B--Storage Service Class; Annex N--Softcopy Presentation State
Storage SOP Classes; Annex O--Structured Reporting Storage SOP Classes.
(C) Part 10 (PS 3.10-2011): Media Storage and File Format for Data
Interchange.
(D) Part 11 (PS 3.11-2011): Media Storage Application Profiles.
(E) Part 12 (PS 3.12-2011): Media Formats and Physical Media for
Media Interchange.
(F) Part 14 (PS 3.14-2011): Grayscale Standard Display Function.
(G) Part 16 (PS 3.16-2011): Content Mapping Resource, section: X-
Ray Radiation Dose SR IOD Templates.
(ii) The sections of the DICOM standard indicated above are
incorporated by reference. The Director of the Federal Register
approves this incorporation by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may obtain a copy of the DICOM standard
from the NEMA Web site at ftp://medical.nema.org/medical/dicom/2011/ or
from the National Electrical Manufacturers Association, 1300 N. 17th
Street, Rosslyn, VA 22209. You may inspect a copy of the DICOM standard
at the NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676
Columbia Parkway, Cincinnati, OH 45226, or at the National Archives and
Records Administration (NARA). For information on the availability of
these materials at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(A) Identification of each miner, chest image, facility, date and
time of the examination shall be encoded within the image information
object, according to Part 3 (PS 3.3-2011) of the DICOM standard,
Information Object Definitions, for the DICOM ``DX'' object. Part 3 is
incorporated by reference and is available as indicated above. If data
compression is performed, it shall be lossless. Exposure parameters
(kVp, mA, time, beam filtration, scatter reduction, radiation exposure)
shall be stored in the DX information object.
(B) Exposure parameters as defined in the DICOM Standard PS 3.16-
2011: Content Mapping Resource, shall additionally be provided, when
such parameters are available from the facility digital image
acquisition system or recorded in a written report or electronic file
and either transmitted to NIOSH or stored at the facility and available
for inspection by NIOSH for 5 years after the examination.
(6) A specific test object may be required on each radiograph for
an objective evaluation of image quality at the discretion of NIOSH.
(7) CR imaging plates shall be inspected at least once a month and
cleaned when necessary by the method recommended by the manufacturer;
(8) A grid or air gap for reducing scattered radiation shall be
used; grids shall not be used that cause Moir[eacute] interference
patterns in either horizontal or vertical images.
(9) The geometry of the radiographic system shall ensure that the
central axis (ray) of the primary beam is perpendicular to the plane of
the CR imaging plate, or DR detector and is correctly aligned to the
grid;
(10) Radiographs shall not be made when the environmental
temperatures and humidity in the facility are outside the
manufacturer's recommended range of the CR and DR equipment to be used.
(11) Before the miner is advised that the examination is concluded,
the radiograph shall be processed and inspected and accepted for
quality by the physician, or if the physician is not available,
acceptance may be made by the radiologic technologist. In a case of a
substandard radiograph, another shall be made immediately. Unacceptable
digital image files shall be fully deleted immediately or rendered
permanently inaccessible in the event that permanent deletion is not
technologically feasible.
(j) The following are not authorized for use under this section:
(1) Digital images derived from film screen chest radiographs
(e.g., by scanning or digital photography); or
(2) Images that were acquired using digital systems and then
printed on transparencies for back-lighted display (e.g., using
tradition view boxes).
14. Revise newly designated Sec. 37.43 to read as follows:
Sec. 37.43 Approval of radiographic facilities that use film.
(a) Facilities become eligible to participate in this program by
demonstrating their ability to make high quality diagnostic chest
radiographs by submitting to NIOSH six or more sample chest radiographs
made and processed at the applicant facility and which are of
acceptable quality to one or more individuals selected by NIOSH from
the panel of B Readers. Applicants shall also submit a radiograph of a
plastic step-wedge object \1\ or other test object (available on loan
from NIOSH) which was made and processed at the same time with the same
technique as the radiographs submitted and processed at the facility
for which approval is sought. At least one chest radiograph and one
test object radiograph shall have been made with each unit to be used
hereunder. All radiographs shall have been made within 15 calendar days
prior to submission and shall be marked to identify the facility where
each radiograph was made, the X-ray machine used, and the date each was
made. The chest radiographs will be returned and may be the same
radiographs submitted pursuant to Sec. 37.50.
---------------------------------------------------------------------------
\1\ The plastic step-wedge object is described in Trout ED,
Kelley JP [1973]. A phantom for the evaluation of techniques and
equipment used for roentgenography of the chest. Amer J Roentgenol
117(4):771-776.
---------------------------------------------------------------------------
(b) Each radiographic facility submitting chest radiographs for
approval under this section shall complete and include an X-ray
Facility Certification Document (Form CDC/NIOSH (M) 2.11) describing
each X-ray unit to be used to make chest radiographs under the Act. The
form shall include:
(1) The date of the last radiation safety inspection by an
appropriate licensing agency or, if no such agency exists, by a
qualified expert as defined in NCRP Report No. 102 (see Sec. 37.45);
(2) The deficiencies found;
(3) A statement that all the deficiencies have been corrected; and
(4) The date of acquisition of the X-ray unit. To be acceptable,
the radiation safety inspection shall have been made within 1 year
preceding the date of application.
(c) Radiographs submitted with applications for approval under this
section will be evaluated by one or more individuals selected by NIOSH
from the panel of B Readers or by a qualified medical physicist or
consultant. Applicants will be advised of any reasons for denial of
approval.
(d) NIOSH or its representatives may make a physical inspection of
the applicant's facility and any approved radiographic facility at any
reasonable time to determine if the requirements of this subpart are
being met.
(e) NIOSH may require a facility periodically to resubmit
radiographs of a test object, sample radiographs, or a Facility
Certification Document for quality control purposes. Approvals granted
hereunder may be suspended or withdrawn by notice in writing when in
the opinion of NIOSH the quality of radiographs or information
submitted under this section warrants such action. A copy of a notice
withdrawing approval will be sent to each operator who has listed the
facility as its facility for giving chest radiographs and shall be
displayed on the mine bulletin board adjacent to the operator's
approved
[[Page 1380]]
plan. The approved plan will be reevaluated by NIOSH in light of this
change.
(f) A formal written quality assurance program shall be established
at each facility addressing radiation exposures, equipment maintenance,
and image quality, and shall conform to the standards set by the
American Association of Physicists in Medicine in AAPM Report No. 74,
Quality Control in Diagnostic Radiology, Report of Task Group
12, Diagnostic X-Ray Imaging Committee, published by Medical
Physics Publishing for AAPM, July 2002, pages 1-19, 47-53, and 56. This
report is incorporated by reference. The Director of the Federal
Register approves this incorporation by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy of AAPM Report
No. 74 from the AAPM Web site at http://www.aapm.org/pubs/reports/rpt_74.pdf or from Medical Physics Publishing, 4513 Vernon Blvd., Madison,
WI 53705. You may inspect a copy of AAPM Report No. 74 at the NIOSH
Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia
Parkway, Cincinnati, OH 45226, or at the National Archives and Records
Administration (NARA). For information on the availability of these
materials at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(g) In conducting medical examinations pursuant to this Part,
physicians and radiographic facilities shall maintain the results and
analysis of these examinations (including any hard copies or digital
files containing individual data, interpretations, and images)
consistent with applicable statutes and regulations governing the
treatment of individually identifiable health information, including,
as applicable, the HIPAA Privacy and Security Rules (45 CFR part 160
and subparts A, C, and E of part 164).
15. Add Sec. 37.44 to read as follows:
Sec. 37.44 Approval of radiographic facilities that use digital
radiography systems.
(a) Applications for facility approval.
(1) Facilities seeking approval shall demonstrate the ability to
make high quality digital chest radiographs by submitting to NIOSH
digital radiographic image files of a test object (e.g., a plastic
step-wedge or chest phantom which will be provided on loan from NIOSH)
as well as digital radiographic image files from six or more sample
chest radiographs which are of acceptable quality to (1) one or more
individuals selected by NIOSH from the panel of B Readers and (2) a
qualified medical physicist or consultant, both designated by NIOSH.
Image files shall be submitted on standard portable media (compact or
digital video disc) and formatted to meet specifications of the Digital
Imaging and Communications in Medicine (DICOM) standard for diagnostic
media interchange Part 12 (PS 3.12-2011): Media Formats and Physical
Media for Media Interchange. Applicants will be advised of any reasons
for denial of approval. All submitted images shall be made within 60
days prior to the date of application using the same technique,
equipment, and software as will be used by the facility under the
requested approval. At least six chest radiographs and one test object
radiograph shall have been made with each digital radiographic unit to
be used by the facility under the requested approval. The corresponding
radiographic image files shall be submitted on standard portable media
(compact or digital video disc) and formatted to meet specifications of
the current Digital Imaging and Communications in Medicine (DICOM)
standard for diagnostic media interchange Part 12 (PS 3.12-2011): Media
Formats and Physical Media for Media Interchange. DICOM Part 12 is
incorporated by reference. The Director of the Federal Register
approves this incorporation by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may obtain a copy of the DICOM standard
from the NEMA Web site at ftp://medical.nema.org/medical/dicom/2011/ or
from the National Electrical Manufacturers Association, 1300 N. 17th
Street, Rosslyn, VA 22209. You may inspect a copy of the DICOM standard
at the NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676
Columbia Parkway, Cincinnati, OH 45226, or at the National Archives and
Records Administration (NARA). For information on the availability of
this document at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Documentation shall include the following: the identity
of the facility where each radiograph was made; the X-ray machine used;
and the model, version, and production date of each image acquisition
software program and hardware component. The submitted sample digital
chest image files shall include at least two taken with the detector in
the vertical position and two in the horizontal position where the
imaging system permits these positions, and at least two chest images
shall be from persons within the highest quartile of chest diameters
(28 cm or greater).
(2) Each radiographic facility submitting chest radiographic image
files for approval under this section shall complete and include an X-
ray Facility Certification Document (Form CDC/NIOSH (M)2.11) describing
each X-ray system component, and the models and versions of image
acquisition hardware and software to be used to make digital chest
radiographs under the Act. The form shall include:
(i) A copy of a dated report signed by a qualified medical
physicist, documenting the evaluation of radiation safety and
performance characteristics specified in this regulation for each
digital radiography system;
(ii) A copy of the report of the most recent radiation safety
inspection by a licensing agency, if such agency exists;
(iii) A listing of all deficiencies noted in either of the reports;
(iv) A statement that all the listed deficiencies have been
corrected; and
(v) The names and relevant training and experience of facility
personnel described in paragraphs (b), (d), and (e) of this section. To
be acceptable, the report by the medical physicist and radiation safety
inspection specified in this paragraph shall have been made within 1
year prior to the date of submission of the application.
(b) Facilities shall maintain ongoing licensure and certification
under relevant local, State, and Federal laws and regulations for all
digital equipment and related processes covered under this Part.
(c) NIOSH or its representatives may make a physical inspection of
the applicant's facility and any approved radiographic facility at any
reasonable time to determine if the requirements of this subpart are
being met.
(d) NIOSH may periodically require a facility to resubmit
radiographic image files of the NIOSH-supplied test object (e.g., step-
wedge or chest phantom), sample radiographs, or a Facility
Certification Document. Approvals granted to facilities under this
section may be suspended or withdrawn by notice in writing when, in the
opinion of NIOSH, deficiencies in the quality of radiographs or
information submitted under this section warrant such action. A copy of
a notice suspending or withdrawing approval will be sent to each
operator that has listed the facility for its use under this Part and
shall be displayed on the mine bulletin board adjacent to the
operator's approved plan. The operator's approved plan may be
reevaluated by NIOSH in response to such suspension or withdrawal.
[[Page 1381]]
(e) A qualified medical physicist who is familiar with the facility
hardware and software systems for image acquisition, manipulation,
display, and storage, shall be on site or available as a consultant.
The physicist shall be trained in evaluating the performance of
radiographic equipment and facility quality assurance programs, and
shall be licensed/approved by a State or territory of the United States
or certified by a competent U.S. national board.
(f) Facilities shall document that testing performed by a qualified
medical physicist has verified that performance of each image
acquisition system for which approval is sought met initial
specifications and standards of the equipment manufacturer and
performance testing as required under paragraphs (b), (e), and (g) of
this section.
(g) A formal written quality assurance program shall be established
at each facility addressing radiation exposures, equipment maintenance,
and image quality, and shall conform to the standards set by the
American Association of Physicists in Medicine in AAPM Report No. 74,
Quality Control in Diagnostic Radiology, Report of Task Group
12, Diagnostic X-Ray Imaging Committee, published by Medical
Physics Publishing for AAPM, July 2002, pages 1-19, 47-53, and 56, and
AAPM Report No. 116, An Exposure Indicator for Digital Radiography,
Report of AAPM Task Group 116, published by AAPM, July 2009, sections
VIII, IX, and X. These reports are incorporated by reference. The
Director of the Federal Register approves this incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may
obtain a copy of AAPM Report No. 74 from the AAPM Web site at http://www.aapm.org/pubs/reports/rpt_74.pdf or from Medical Physics
Publishing, 4513 Vernon Blvd., Madison, WI 53705. You may obtain a copy
of AAPM Report No. 116 from the AAPM Web site at http://www.aapm.org/pubs/reports/RPT_116.PDF or from American Association of Physicists in
Medicine, One Physics Ellipse, College Park, MD 20740. You may inspect
a copy of AAPM Report No. 74 and No. 116 at the NIOSH Docket Office,
Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati,
OH 45226, or at the National Archives and Records Administration
(NARA). For information on the availability of these materials at NARA,
call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(1) Applications for facility approval shall include a
comprehensive assessment by a qualified medical physicist within 12
months prior to application addressing the performance of X-ray
generators, automatic exposure controls, and image capture systems. The
assessment shall comply with the following guidelines: American
Association of Physicists in Medicine, AAPM Report No. 93, Acceptance
Testing and Quality Control of Photostimulable Storage Phosphor Imaging
Systems, Report of AAPM Task Group 10, published by AAPM, October 2006,
pages 1-68; AAPM Report No. 74, Quality Control in Diagnostic
Radiology, Report of Task Group 12, Diagnostic X-Ray Imaging
Committee, published by Medical Physics Publishing for AAPM, July 2002,
page 6-11; and AAPM Report No. 14, Performance Specifications and
Acceptance Testing for X-Ray Generators and Automatic Exposure Control
Devices, Report of the Diagnostic X-Ray Imaging Committee Task Group on
Performance Specifications and Acceptance Testing for X-Ray Generators
and Automatic Exposure Control Devices, published by the American
Institute of Physics, January 1985, pages 1-96. These reports are
incorporated by reference. The Director of the Federal Register
approves this incorporation by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may obtain a copy of AAPM Report No. 93
from the AAPM Web site at http://www.aapm.org/pubs/reports/RPT_93.pdf
or from the American Association of Physicists in Medicine, One Physics
Ellipse, College Park, MD 20740. You may obtain a copy of AAPM Report
No. 74 from the AAPM Web site at http://www.aapm.org/pubs/reports/rpt_74.pdf or from Medical Physics Publishing, 4513 Vernon Blvd., Madison,
WI 53705. You may obtain a copy of AAPM Report No.14 from the AAPRM Web
site at http://www.aapm.org/pubs/reports/rpt_14.pdf or from the
Executive Secretary, American Association of Physicists in Medicine,
335 E. 45 Street, New York, NY 10017. A copy of AAPM Reports No. 93,
74, and 14 may be inspected at the NIOSH Docket Office, Robert A. Taft
Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226, or
at the National Archives and Records Administration (NARA). For
information on the availability of these materials at NARA, call (202)
741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(2) Radiographic technique charts shall be used that are developed
specifically for the X-ray system and detector combinations used,
indicating exposure parameters by anatomic measurements. If automated
exposure control devices are used, calibration for chest imaging shall
be documented using the actual voltages and image capture systems.
Radiological exposures resulting from at least ten (randomly selected)
digital chest images obtained at the facility shall be monitored at
least quarterly to detect and correct potential dose creep, using
methods specified in: American Association of Physicists in Medicine in
AAPM Report No. 31, Standardized Methods for Measuring Diagnostic X-Ray
Exposures, Report of Task Group 8, Diagnostic X-Ray Imaging Committee,
published by the American Institute of Physics, March 2005. This report
is incorporated by reference. The Director of the Federal Register
approves this incorporation by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may obtain a copy of AAPM Report No. 31
from the AAPM Web site at http://www.aapm.org/pubs/reports/RPT_31.pdf
or from the American Institute of Physics, c/o AIDC, 64 Depot Road,
Colchester, VT 05446. A copy of AAPM Report No. 31 may be inspected at
the NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676
Columbia Parkway, Cincinnati, OH 45226, or at the National Archives and
Records Administration (NARA). For information on the availability of
these materials at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Radiation exposures shall be compared to a
professionally accepted reference level published in the American
College of Radiology (ACR) Practice Guideline For Diagnostic Reference
Levels in Medical X-Ray Imaging, Revised 2008 (Res. 3), pages 1-6. The
ACR Practice Guideline is incorporated by reference. The Director of
the Federal Register approves this incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a
copy of the ACR Practice Guideline from the ACR Web site at http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/med_phys/reference_levels.aspx. You may inspect a copy of the ACR
Practice Guideline at the NIOSH Docket Office, Robert A. Taft
Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226, or
at the National Archives and Records Administration (NARA). For
information on the availability of this
[[Page 1382]]
material at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
In addition, the medical physicist shall submit an annual assessment of
measured or estimated radiation exposures, with specific recommended
actions to minimize exposures during examinations performed under this
Part.
(3) For each digital radiography device and system, performance
shall be monitored annually in accordance with the recommendations of
AAPM Report No. 93, except for the testing specifically excluded below.
Documentation shall be maintained on the completion of quality
assurance testing, including the reproducibility of X-ray output,
linearity and reproducibility of mA settings, accuracy and
reproducibility of timer and kVp settings, accuracy of source-to-
detector distance, and X-ray field focal spot size, selection, beam
quality, congruence and collimation. For DR systems, the following
tests listed in AAPM Report No. 93, Acceptance Testing and Quality
Control of Photostimulable Storage Phosphor Imaging Systems, 2006, are
not required under this Part:
(i) Section 8.4.5: Laser beam function
(ii) Section 8.4.9: Erasure Thoroughness
(iii) Section 8.4.11: Imaging Plate (IP) Throughput
(4) Facilities shall maintain documentation, available for
inspection by NIOSH for 5 years, of the ongoing implementation of
policies and procedures for monitoring and evaluating the effective
management, safety, and proper performance of chest image acquisition,
digitization, processing, compression, transmission, display,
archiving, and retrieval functions of digital radiography devices and
systems.
(h) In conducting medical examinations pursuant to this Part,
physicians and radiographic facilities shall maintain the results and
analysis of these examinations (including any hard copies or digital
files containing individual data, interpretations, and images)
consistent with applicable statutes and regulations governing the
treatment of individually identifiable health information, including,
as applicable, the HIPAA Privacy and Security Rules (45 CFR Part 160
and Subparts A, C, and E of Part 164).
16. Revise newly designated Sec. 37.45 to read as follows:
Sec. 37.45 Protection against radiation emitted by radiographic
equipment.
Except as otherwise specified in Sec. 37.41 and Sec. 37.42,
radiographic equipment, its use and the facilities (including mobile
facilities) in which such equipment is used, shall conform to
applicable State or territorial and Federal regulations. Where no
applicable regulations exist, radiographic equipment, its use and the
facilities (including mobile facilities) in which such equipment is
used shall conform to the recommendations of the National Council on
Radiation Protection and Measurements in NCRP Report No. 102, Medical
X-ray, Electron Beam, and Gamma-Ray Protection for Energies Up to 50
MeV, Equipment Design, Performance, and Use, 1989; NCRP Report No. 105,
Medical Radiation Protection for Medical and Allied Health Personnel,
1989; and in NCRP Report No. 49, Structural Shielding Design and
Evaluation for Medical Use of X-Rays and Gamma Rays of Energies up to
10 MeV, 1976. These documents are incorporated by reference. The
Director of the Federal Register approves this incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may
obtain a copy of the NCRP reports from NCRP Publications, 7910 Woodmont
Avenue, Suite 400, Bethesda, MD 20814-3095, Telephone (800) 229-2652 or
from http://www.ncrponline.org/Publications/Publications.html. You may
inspect a copy of the ACR Practice Guideline at the NIOSH Docket
Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway,
Cincinnati, OH 45226, or at the National Archives and Records
Administration (NARA). For information on the availability of these
materials at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
17. Revise the undesignated center heading and Sec. 37.50 to read
as follows:
Specifications for Interpretation, Classification, and Submission of
Chest Radiographs
Sec. 37.50 Interpreting and classifying chest radiographs--film.
(a) Chest radiographs shall be interpreted and classified in
accordance with the International Labour Office (ILO) International
Classification of Radiographs for Pneumoconioses, 2011. The ILO
Classification is incorporated by reference. The Director of the
Federal Register approves this incorporation by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. You may purchase a copy of the
ILO Classification from ILO Publications, International Labour Office,
CH-1211 Geneva 22, Switzerland, or from the ILO Web site at http://www.ilo.org/publns. You may inspect the ILO Classification at the NIOSH
Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia
Parkway, Cincinnati, OH 45226, or at the National Archives and Records
Administration (NARA). For information on the availability of these
materials at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Chest radiograph interpretations and classifications
shall be recorded on a paper or electronic Roentgenographic
Interpretation Form (Form CDC/NIOSH (M)2.8).
(b) Radiographs shall be interpreted and classified only by a
physician who reads chest radiographs in the normal course of practice
and who has demonstrated proficiency in classifying the pneumoconioses
in accordance with Sec. 37.52.
(1) Initial clinical interpretations and notification of findings
other than pneumoconiosis under Sec. 37.50(a) shall be provided by a
qualified physician who has all required licensure and privileges, and
interprets chest radiographs in the normal course of practice.
(c) All interpreters, whenever interpreting chest radiographs made
under the Act, shall have immediately available for reference a
complete set of the ILO International Classification of Radiographs for
Pneumoconioses, 2011.
(d) In all view boxes used for making interpretations:
(1) Fluorescent lamps shall be simultaneously replaced with new
lamps at 6-month intervals;
(2) All the fluorescent lamps in a panel of boxes shall have
identical manufacturer's ratings as to intensity and color;
(3) The glass, internal reflective surfaces, and the lamps shall be
kept clean;
(4) The unit shall be so situated as to minimize front surface
glare.
Sec. Sec. 37.51-37.53 [Redesignated]
18a. Redesignate Sec. Sec. 37.51 through 37.53 as Sec. Sec. 37.52
through 37.54 respectively.
18b. Add new Sec. 37.51 to read as follows:
Sec. 37.51 Interpreting and classifying chest radiographs--digital
radiography systems.
(a) For each chest radiograph obtained at an approved facility
using a digital radiography system, a qualified and licensed physician
who reads chest radiographs in the normal course of practice shall
provide an initial clinical interpretation and notification, as
[[Page 1383]]
specified in Sec. 37.54, of any significant abnormal findings other
than pneumoconiosis.
(b) Chest radiographs shall be classified for pneumoconiosis by
physician readers who have demonstrated ongoing proficiency, as
specified in Sec. 37.52(b), in classifying the pneumoconioses in a
manner consistent with the ILO International Classification of
Radiographs of Pneumoconioses 2011. The ILO Classification is
incorporated by reference. The Director of the Federal Register
approves this incorporation by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may purchase a copy of the ILO
Classification from ILO Publications, International Labour Office, CH-
1211 Geneva 22, Switzerland, or from the ILO Web site at http://www.ilo.org/publns. You may inspect the ILO Classification at the NIOSH
Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia
Parkway, Cincinnati, OH 45226, or at the National Archives and Records
Administration (NARA). For information on the availability of these
materials at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Chest radiograph interpretations and classifications
shall be recorded on a paper or electronic Roentgenographic
Interpretation Form (Form CDC/NIOSH (M)2.8).
(c) All interpreters, whenever classifying digitally-acquired chest
radiographs made under the Act, shall have immediately available for
reference a complete set of NIOSH-approved standard digital chest
radiographic images provided for use with the ILO International
Classification of Radiographs of Pneumoconioses, 2011. Only NIOSH-
approved standard digital images shall be used for classifying digital
chest images for pneumoconiosis. Modification of the appearance of the
standard images using software tools is not permitted.
(d) Viewing systems should enable readers to display the coal
miner's chest image at the full resolution of the image acquisition
system, side-by-side with the selected NIOSH-approved standard images
for comparison.
(1) Image display devices shall be flat panel monitors displaying
at least 3 MP at 10 bit depth. Image displays and associated graphics
cards shall meet the calibration and other specifications of the
National Electrical Manufacturers Association's Digital Imaging and
Communications in Medicine (DICOM) standard Part 14 (PS 3.14-2011):
Grayscale Standard Display Function. DICOM Part 14 is incorporated by
reference. The Director of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain a copy of the DICOM standard from the NEMA Web
site at ftp://medical.nema.org/medical/dicom/2011/or from the National
Electrical Manufacturers Association, 1300 N. 17th Street, Rosslyn, VA
22209. You may inspect a copy of the DICOM standard at the NIOSH Docket
Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway,
Cincinnati, OH 45226, or at the National Archives and Records
Administration (NARA). For information on the availability of this
document at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
Image displays and associated graphics cards shall not deviate by
more than 10 percent from the grayscale standard display function
(GSDF) when assessed according the American Association of Physicists
in Medicine (AAPM) On-Line Report No. 03, Assessment of Display
Performance for Medical Imaging Systems, Task Group 18, Imaging
Informatics Subcommittee, published by AAPM, April 2005, pages 1-146.
This report is incorporated by reference. The Director of the Federal
Register approves this incorporation by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy of On-Line
Report No. 03 from American Association of Physicists in Medicine, One
Physics Ellipse, College Park, MD 20740 or from http://www.aapm.org/pubs/reports/OR_03.pdf. You may inspect a copy of AAPM On-Line Report
No. 03 at the NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34,
4676 Columbia Parkway, Cincinnati, OH 45226, or at the National
Archives and Records Administration (NARA). For information on the
availability of this document at NARA, call (202) 741-6030 or go to
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(2) Display system luminance (maximum and ratio), relative noise,
linearity, modulation transfer function (MTF), frequency, and glare
should meet or exceed recommendations listed in AAPM On-Line Report No.
03, Assessment of Display Performance for Medical Imaging Systems, Task
Group 18, Imaging Informatics Subcommittee, published by AAPM, April
2005, pages 1-146. This report is incorporated by reference. The
Director of the Federal Register approves this incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may
obtain a copy of On-Line Report No. 03 from American Association of
Physicists in Medicine, One Physics Ellipse, College Park, MD 20740 or
from http://www.aapm.org/pubs/reports/OR_03.pdf. You may inspect a
copy of AAPM On-Line Report No. 03 at the NIOSH Docket Office, Robert
A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, OH
45226, or at the National Archives and Records Administration (NARA).
For information on the availability of this document at NARA, call
(202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Viewing displays
shall have a maximum luminance of at least 171 cd/m\2\, a ratio of
maximum luminance to minimum luminance of at least 250, and a glare
ratio greater than 400. The contribution of ambient light reflected
from the display surface, after light sources have been minimized,
shall be included in luminance measurements.
(3) Displays shall be situated so as to minimize front surface
glare. Readers shall minimize reflected light from ambient sources
during the performance of classifications.
(4) Measurements of the width and length of pleural shadows and the
diameter of opacities shall be taken using calibrated software
measuring tools. If permitted by the viewing software, a record shall
be made of the presentation state(s), including any noise reduction and
edge enhancement or restoration functions that were used in performing
the classification, including any annotations and measurements.
(e) Quality control procedures for devices used to display chest
images for classification shall comply with the recommendations of the
American Association of Physicists in Medicine AAPM On-Line Report No.
03, Assessment of Display Performance for Medical Imaging Systems, Task
Group 18, Imaging Informatics Subcommittee, published by AAPM, April
2005, pages 1-146. This report is incorporated by reference. The
Director of the Federal Register approves this incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may
obtain a copy of On-Line Report No. 03 from American Association of
Physicists in Medicine, One Physics Ellipse, College Park, MD 20740 or
from http://www.aapm.org/pubs/reports/OR_03.pdf. You may inspect a
copy of AAPM On-Line Report No. 03 at the
[[Page 1384]]
NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia
Parkway, Cincinnati, OH 45226, or at the National Archives and Records
Administration (NARA). For information on the availability of this
document at NARA, call (202) 741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(1) If automatic quality assurance systems are used, visual
inspection shall be performed using one or more test patterns
recommended by the medical physicist every 6 months, or more
frequently, to check for defects that automatic systems may not detect.
(2) [Reserved]
(f) Classification of CR and DR digitally-acquired chest
radiographs under this Part shall be performed based on the viewing of
images displayed as soft copies using the viewing workstations
specified in this section. Classification of radiographs shall not be
based on the viewing of hard copy printed transparencies of images that
were digitally-acquired.
(g) The classification chest radiographs based on digitized copies
of chest radiographs that were originally acquired using film-screen
techniques is not permissible under this Part.
19. Revise newly designated Sec. 37.52 to read as follows:
Sec. 37.52 Proficiency in the use of systems for classifying the
pneumoconioses.
(a) First or A Readers:
(1) Approval as an A Reader shall continue if established prior to
the effective date of these regulations.
(2) Physicians who desire to be A Readers must demonstrate their
proficiency in classifying the pneumoconioses by either:
(i) Submitting to NIOSH from the physician's files six sample chest
radiographs which are considered properly classified by one or more
individuals selected by NIOSH from the panel of B Readers. The six
radiographs shall consist of two without pneumoconiosis, two with
simple pneumoconiosis, and two with complicated pneumoconiosis (these
may be the same radiographs submitted for facility approval pursuant to
Sec. 37.43 and Sec. 37.44). The films will be returned to the
physician. The interpretations shall be on the Roentgenographic
Interpretation Form (Form CDC/NIOSH (M)2.8), or;
(ii) Satisfactory completion, since June 11, 1970, of a course
approved by NIOSH on the ILO International Classification of
Radiographs of Pneumoconioses.
(b) Final or B Readers:
(1) Approval as a B Reader established prior to October 1, 1976,
shall hereby be terminated.
(2) Proficiency in evaluating chest radiographs for radiographic
quality and in the use of the ILO Classification for interpreting chest
radiographs for pneumoconiosis and other diseases shall be demonstrated
by those physicians who desire to be B Readers by taking and passing a
specially-designed proficiency examination given on behalf of or by
NIOSH at a time and place specified by NIOSH. Each physician who
desires to take the digital version of the examination will be provided
a complete set of the current NIOSH-approved standard reference digital
radiographs. Physicians who qualify under this provision need not be
qualified under paragraph (a) of this section.
(c) Physicians who wish to participate in the program shall
familiarize themselves with the necessary components for attainment of
reliable classification of chest radiographs for the pneumoconioses \2\
and apply using an Interpreting Physician Certification Document (Form
CDC/NIOSH (M)2.12).
---------------------------------------------------------------------------
\2\ NIOSH Safety and Health Topic. Chest Radiography:
Radiographic Classification [http://www.cdc.gov/niosh/topics/chestradiography/radiographic-classification.html]. Date accessed:
January 25, 2011.
---------------------------------------------------------------------------
20. Revise newly designated Sec. 37.53 to read as follows:
Sec. 37.53 Method of obtaining definitive interpretations.
(a) All chest radiographs which are first interpreted by an A or B
Reader will be submitted by NIOSH to a B Reader qualified as described
in Sec. 37.52. If there is agreement between the two interpretations,
as described in paragraph (b) of this section, the result shall be
considered final and reported to MSHA for transmittal to the miner.
When agreement is lacking, NIOSH shall obtain a third interpretation
from the panel of B Readers. If any two of the three interpretations
demonstrate agreement, the result shall be considered the final
determination. If agreement is lacking among the three interpretations,
NIOSH will obtain independent classifications from two additional B
Readers selected from the panel, and the final determination will be
the median category derived from the total of five classifications.
(b) Two interpretations shall be considered to be in agreement when
they are derived from complete classifications recorded using approved
paper or electronic versions of the Roentgenographic Interpretation
Form (Form CDC/NIOSH (M)2.8) and received by NIOSH, and both find
either stage A, B, or C complicated pneumoconiosis, or, for simple
pneumoconiosis, are both in the same major category or (with one
exception noted below) are within one minor category (ILO
Classification 12-point scale) of each other. In the last situation,
the higher of the two interpretations shall be reported. The only
exception to the one minor category principle is a reading sequence of
0/1, 1/0, or 1/0, 0/1, which is not considered agreement.
21. Revise newly designated Sec. 37.54 to read as follows:
Sec. 37.54 Notification of abnormal radiographic findings.
(a) Findings of, or findings suggesting, enlarged heart,
tuberculosis, lung cancer, or any other significant abnormal findings
other than pneumoconiosis shall be communicated by the first physician
to interpret the radiograph to the miner or to the designated physician
of the miner indicated on the Miner Identification Document. A notice
of the communication shall be submitted to NIOSH. NIOSH will also
notify the miner to contact his or her physician when any physician who
interprets and classifies the miner's radiograph reports significant
abnormal findings other than pneumoconiosis.
(b) In addition, when NIOSH has more than one radiograph of a miner
in its files and the most recent examination was interpreted to show
enlarged heart, tuberculosis, cancer, complicated pneumoconiosis, and
any other significant abnormal findings, NIOSH will submit all of the
miner's radiographs in its files with their respective interpretations
to a B Reader. The B Reader will report any significant changes or
progression of disease or other comments to NIOSH and NIOSH shall
submit a copy of the report to the miner or to the miner's designated
physician.
(c) All final findings regarding pneumoconiosis will be sent to the
miner by MSHA in accordance with section 203 of the Act (see 30 CFR
part 90). Positive findings with regard to pneumoconiosis will be
reported to the miner or to the miner's designated physician by NIOSH.
(d) NIOSH will make every reasonable effort to process the findings
described in paragraph (c) of this section within 60 days of receipt of
the information described in Sec. 37.60 in a complete and acceptable
form. The information forwarded to MSHA will be in a form intended to
facilitate prompt dispatch of the findings to the miner. The results of
[[Page 1385]]
an examination made of a miner may not be processed by NIOSH if the
examination was made within 6 months of the date of a previous
acceptable examination.
22. Amend Sec. 37.60 by revising paragraphs (a) through (d) to
read as follows:
Sec. 37.60 Submitting required chest radiographs and miner
identification documents.
(a) Each chest radiograph required to be made under this subpart,
together with the completed Roentgenographic Interpretation Form and
the completed Miner Identification Document, shall be submitted
together for each miner to NIOSH within 14 calendar days after the
radiographic examination is given and become the property of NIOSH.
(1) When the radiograph is digital, the image file for each
radiograph, together with either hard copy or electronic versions of
the completed Roentgenographic Interpretation Form and the completed
Miner Identification Document, shall be submitted to NIOSH using the
software and format specified by NIOSH either using portable electronic
media, or a secure electronic file transfer within 14 calendar days
after the radiographic examination. NIOSH will notify the submitting
facility when it has received the image files and forms from the
examination. After this notification, the facility will permanently
delete, or if this is not technologically feasible for the imaging
system used, render permanently inaccessible all files and forms from
its electronic and physical files.
(2) [Reserved]
(b) If NIOSH deems any submission under paragraph (a) of this
section inadequate, it will notify the operator of the deficiency. The
operator shall promptly make appropriate arrangements for the necessary
reexamination.
(c) Failure to comply with paragraph (a) or (b) of this section
shall be cause to revoke approval of a plan or any other approval as
may be appropriate. An approval which has been revoked may be
reinstated at the discretion of NIOSH after it receives satisfactory
assurances and evidence that all deficiencies have been corrected and
that effective controls have been instituted to prevent a recurrence.
(d) Chest radiographs and other required documents shall be
submitted only for miners.
* * * * *
23. Revise Sec. 37.70 to read as follows:
Sec. 37.70 Review of interpretations.
(a) Any miner who believes the interpretation for pneumoconiosis
reported to him or her by MSHA is in error may file a written request
with NIOSH that his or her radiograph be reevaluated. If the
interpretation was based on agreement between an A Reader and a B
Reader, NIOSH will obtain one or more additional interpretations by B
Readers as necessary to obtain agreement in accord with Sec. 37.53,
and MSHA shall report the results to the miner together with
notification from MSHA of any rights which may accrue to the miner in
accordance with Sec. 37.7. If the reported interpretation was based on
agreement between two (or more) B Readers, the reading will be accepted
as conclusive and the miner shall be so informed by MSHA.
(b) Any operator who is directed by MSHA to transfer a miner to a
less dusty atmosphere based on the most recent examination made
subsequent to August 1, 1978, may file a written request with NIOSH to
review its findings. The standards set forth in paragraph (a) of this
section apply and the operator and miner will be notified by MSHA
whether the miner is entitled to the option to transfer.
24. Revise Sec. 37.80 to read as follows:
Sec. 37.80 Availability of records for radiographs.
(a) Medical information and radiographs on miners will be released
by NIOSH only with the written consent from the miner, or if the miner
is deceased, written consent from the miner's widow or widower, next of
kin, or legal representative.
(b) To the extent authorized, radiographs will be made available
for examination only at NIOSH.
25. Amend Sec. 37.201 by revising paragraph (d) to read as
follows:
Sec. 37.201 Definitions.
* * * * *
(d) NIOSH means the National Institute for Occupational Safety and
Health, United States Public Health Service, Department of Health and
Human Services, Post Office Box 4258, Morgantown, WV 26504.
26. Amend Sec. 37.202 by revising paragraphs (a)(2) and (b) to
read as follows:
Sec. 37.202 Payment for autopsy.
(a) * * *
(2) Submits the findings and other materials to NIOSH in accordance
with this subpart within 180 calendar days after having performed the
autopsy; and
* * * * *
(b) The Secretary will pay to any pathologist entitled to payment
under paragraph (a) of this section and additional $10 if the
pathologist can obtain and submits a good quality copy or original of a
chest radiograph (posteroanterior view) made of the subject of the
autopsy within 5 years prior to his death together with a copy of any
interpretation made.
26. Amend Sec. 37.204 by revising the introductory text and
paragraph (b), and removing Figure 1, to read as follows:
Sec. 37.204 Procedure for obtaining payment.
Every claim for payment under this subpart shall be submitted to
NIOSH and shall include:
* * * * *
(b) Completed PHS Consent, Release and History form (Form CDC/NIOSH
(M)2.6). This form may be completed with the assistance of the
pathologist, attending physician, family physician, or any other
responsible person who can provide reliable information.
* * * * *
Dated: October 11, 2011.
Kathleen Sebelius,
Secretary.
[FR Doc. 2011-33164 Filed 1-6-12; 8:45 am]
BILLING CODE 4163-18-P