Specifications for Medical Examinations of Coal Miners, 73270-73290 [2016-24405]
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Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations
J. Plain Writing Act of 2010
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 37
[Docket No. CDC–2014–0011; NIOSH–276]
RIN 0920–AA57
Specifications for Medical
Examinations of Coal Miners
Centers for Disease Control and
Prevention, HHS.
ACTION: Final rule.
AGENCY:
With this action, the
Department of Health and Human
Services (HHS), in accordance with
recent rulemaking by the Department of
Labor’s Mine Safety and Health
Administration (MSHA), finalizes
amendments to Coal Workers’ Health
Surveillance Program regulations to
establish standards for the approval of
facilities to conduct spirometry and
requires that all coal mine operators
submit a plan for the provision of
spirometry testing and X-ray
examinations to all surface and
underground coal miners.
DATES: This rule is effective on
November 23, 2016.
FOR FURTHER INFORMATION CONTACT: A.
Scott Laney, Research Epidemiologist,
Division of Respiratory Disease Studies,
NIOSH, Centers for Disease Control and
Prevention, 1095 Willowdale Road, MS
HG900.2, Morgantown, WV 26505–
2888; (304) 285–5754 (this is not a tollfree number); alaney@cdc.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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Table of Contents
I. Public Participation
II. Background
A. History of Coal Workers’ Health
Surveillance Program and Statutory
Authority
B. Need for Rulemaking
III. Summary of Final Rule and Response to
Public Comment
A. Subpart—Chest Radiographic
Examinations
B. Subpart—Spirometry Examinations
C. Subpart—General Requirements
IV. Regulatory Assessment Requirements
A. Executive Orders 12866 and 13563
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
D. Small Business Regulatory Enforcement
Fairness Act
E. Unfunded Mandates Reform Act of 1995
F. Executive Order 12988 (Civil Justice)
G. Executive Order 13132 (Federalism)
H. Executive Order 13045 (Protection of
Children From Environmental Health
Risks and Safety Risks)
I. Executive Order 13211 (Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use)
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I. Public Participation
Interested persons or organizations
were invited to participate in this
rulemaking by submitting written views,
arguments, recommendations, and data.
Comments were invited on any topic
related to this rulemaking.
HHS received submissions to the
docket from two commenters, including
a trade association representing coal
mine operators and a spirometry expert.
miners are to be given in accordance
with specifications prescribed by the
Secretary of Health and Human Services
(30 U.S.C. 843(a)). The Mine Act also
grants the Secretary, HHS general
authority to issue regulations as is
deemed appropriate to carry out
provisions of the Act (30 U.S.C. 957),
and grants NIOSH the authority to
conduct activities in the field of coal
mine health on behalf of the Secretary,
HHS (30 U.S.C. 951(b)).
II. Background
B. Need for Rulemaking
A. History of Coal Workers’ Health
Surveillance Program and Statutory
Authority
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 coal workers’
pneumoconiosis (pneumoconiosis),
silicosis, and chronic obstructive
pulmonary disease, including chronic
bronchitis and emphysema.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 National Institute for
Occupational Safety and Health
(NIOSH) Coal Workers’ Health
Surveillance Program (CWHSP), also
authorized by the Mine Act, was
established to detect pneumoconiosis
and prevent its progression in
individual miners, while at the same
time providing information for
evaluation of temporal and geographic
trends in pneumoconiosis. To inform
each miner of his or her health status,
the Act requires that coal mine
operators provide each miner who
begins work at a coal mine for the first
time 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
a coal mine must be offered a chest
radiograph approximately every 5 years.
All chest radiographs and other
supplemental tests deemed necessary to
protect the health and safety of U.S. coal
On May 1, 2014, the Mine Safety and
Health Administration (MSHA) in the
Department of Labor published a final
rule amending existing health and safety
standards in 30 CFR part 72 to improve
health protections for coal miners,
including the expansion of requirements
for medical surveillance.2 The
amendments added a new section,
§ 72.100, to require that both
underground and surface coal mine
operators provide to each miner chest Xrays and spirometry tests using facilities
approved by NIOSH, as well as the
documentation of occupational history
and symptom assessment.
The expansion of MSHA’s medical
surveillance requirements caused HHS
to amend regulations in 42 CFR part 37
pertaining to the CWHSP, thereby
expanding the scope of the Program to
include coal miners who work in
surface coal mines and adding
spirometry testing and symptom
assessment for all miners. In response to
MSHA’s rulemaking, NIOSH published
an interim final rule on August 4, 2014
(August 2014 IFR) to expand the
existing CWHSP to provide chest
radiographic examinations to miners
who work in surface coal mines and
establish requirements for spirometry
testing for all coal miners under part
37.3 This action finalizes those
provisions promulgated by the August
2014 IFR.
1 Edward L Petsonk and John E Parker, Coal
Workers’ Lung Diseases and Silicosis, in Fishman’s
Pulmonary Diseases and Disorders, 967 (Alfred P.
Fishman ed., McGraw-Hill, 4th ed., 2008).
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III. Summary of Final Rule and
Response to Public Comment
This document finalizes the August
2014 IFR. The following section-bysection summary describes and explains
the amendments to certain provisions of
part 37. Public comments are also
summarized and answered. The final
regulatory text is provided in the last
section of this document.
2 79
3 79
FR 24814.
FR 45110.
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A. Subpart—Chest Radiographic
Examinations
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Section 37.1 Scope
Section 37.1 provides the scope of the
provisions in Subpart—Chest
Radiographic Examinations, and is
amended to clarify the purpose of this
subpart. Under this subpart, coal mine
operators are required to provide
radiographic examinations to each
current and new coal miner, using
medical facilities approved by NIOSH
according to the standards established
in this subpart. Because no comments
were submitted on this section and no
changes are made to the regulatory text,
this section is not included in the
regulatory text below.
Section 37.2 Definitions
Section 37.2 contains definitions for
terms that appear throughout this
subpart and the new subparts
(Subpart—Spirometry Testing and
Subpart—General Requirements). The
existing definitions of several terms are
revised and a new definition of ‘‘B
Reader’’ is added, as discussed below.
The definition ‘‘Act,’’ which refers to
the Federal Mine Safety and Health Act
of 1977, is revised to include reference
to the Public Law number and
amendments.
The definition ‘‘convenient time and
place’’ is revised to strike the phrase
‘‘with respect to the conduct of any
examination under this subpart,’’
because that phrase is not used in part
37. Additional language is added to
clarify how this term is to be
interpreted. Although this definition
was not included in the August 2014
IFR, revising it to be consistent with the
language in §§ 37.40 and 37.100 is thus
a logical outgrowth of this rulemaking.
The definition ‘‘digital radiography
systems’’ is changed to replace the word
‘‘X-ray’’ with ‘‘radiographic.’’ Although
this definition was not included in the
August 2014 IFR, revising it is
consistent with changes made to § 37.51
in this final action and is thus a logical
outgrowth of this rulemaking.
The definition ‘‘ILO Classification’’ is
revised to clarify that using the term
‘‘digital chest image file’’ includes all
electronic standard chest images
included in the set of film radiographs
provided by the International Labour
Office (ILO) in the International
Classification of Radiographs of
Pneumoconioses. The definition is also
revised to recognize that NIOSH must
approve other sets of chest images files
as equivalent to the ILO Classification.
The ILO Classification is incorporated
by reference into certain sections in part
37. Although this definition was not
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included in the August 2014 IFR,
revising it to recognize digitized image
files is consistent with changes made to
§ 37.51 in this final action, and is thus
a logical outgrowth of this rulemaking.
The definition ‘‘NIOSH’’ is revised to
replace the former name of the NIOSH
division responsible for the CWHSP
with its new name, Respiratory Health
Division (RHD). RHD is the
organizational unit within NIOSH
responsible for administration of the
CWHSP.
The definition ‘‘Panel of B Readers’’ is
revised to clarify that B Readers are
certified by NIOSH and classify or
otherwise evaluate radiographs for the
CWHSP.
The definition ‘‘radiologic
technologist’’ is revised to clarify
terminology by replacing ‘‘chest
images’’ with ‘‘chest radiographs.’’
A new definition of ‘‘B Reader’’ is
added to direct readers to § 37.52, which
requires physicians who wish to
evaluate and classify chest radiographs
for pneumoconiosis to take and pass a
specially designed proficiency
examination given by NIOSH. This
definition is predicated on existing
language in § 37.52, and is thus a logical
outgrowth of the August 2014 IFR.
Finally, the definition ‘‘facility’’ is
moved from § 37.91 and is unchanged.
No comments were submitted on this
section.
Section 37.3 Chest Radiographs
Required for Miners
Section 37.3 requires mine operators
to provide miners an opportunity to
receive a chest radiograph. Paragraphs
(a)(1) and (2), concerning the provision
of each employed miner an opportunity
for a chest radiograph at least 3.5 to 4.5
years after the previous period for the
conduct of such examinations, are
revised to eliminate redundancy and
provide greater clarity regarding the
deadlines for voluntary examinations.
The sentence specifying that the period
during which examinations must begin
is removed because it does not provide
any additional information and may be
confusing. The example provided in
paragraph (a)(2) is also removed for
similar reasons.
No changes are made to paragraph (b),
which establishes the periodicity of
three required initial chest radiographs.
Paragraph (c), which establishes that
NIOSH will notify the miner when it is
time for a second or third radiography
examination and will notify the operator
under certain circumstances, is revised
for clarity.
Paragraph (d), concerning the
availability of chest radiographs, is
revised to replace ‘‘subpart’’ with ‘‘part’’
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to clarify that radiographs must be made
available by an operator in accordance
with a plan submitted and approved by
NIOSH in accordance with this part. As
discussed in the August 2014 IFR, the
section requiring operator plans for
medical examinations has been removed
from this subpart and replaced in
Subpart—General Requirements.
One commenter asked that HHS
require miners to submit to mandatory
respiratory examinations. NIOSH does
not have legal authority to require coal
miners to submit to medical
examinations. Although section 203(a)
of the Mine Act (30 U.S.C. 843(a)) states
that medical examinations shall be
given to miners at certain intervals, it
states elsewhere in that section that
miners are to have ‘‘the opportunity’’ to
have such examinations. Moreover,
NIOSH concurs with MSHA’s position,
as addressed in the agency’s May 1,
2014 final rule in response to public
comment, that requiring miners to
submit to medical examinations against
their will would not be appropriate.4 No
changes are made to the regulatory text
in response to public comment.
Section 37.4 Chest Radiographic
Examinations Conducted by the
Secretary
Section 37.4 details the conditions
under which the HHS Secretary will
determine whether to conduct a chest
radiographic examination. Paragraph
(a), which details the circumstances
under which the Secretary, HHS, will
arrange for chest radiographs at a
particular mine, is unchanged.
‘‘Shall’’ is replaced with ‘‘must,’’ in
accordance with Federal plain language
guidelines, in paragraph (b), which
requires the operator to reimburse the
Secretary or person, agency, or
institution directed by the Secretary to
conduct radiography examinations, and
paragraph (c), which requires the
examinations arranged by the Secretary
to be given according to the periodicity
requirements in § 37.3.
Paragraph (d), which stipulates that
operators participating in the National
Study of Coal Workers’ Pneumoconiosis
would not be responsible for assuming
the cost of providing chest radiographs,
is removed in its entirety because that
study no longer exists. No comments
were submitted on this section and no
changes are made to the regulatory text.
Section 37.10 Standards Incorporated
by Reference
Section 37.10 provides references to
the standards incorporated by reference
4 See MSHA final rule, 79 FR 24814, at 24928
(May 1, 2014).
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into part 37. This section is amended
slightly to update the name of the
NIOSH Division of Respiratory Disease
Studies, now known as the Respiratory
Health Division. The link to the
American College of Radiology
publication has been updated. No
public comment was received and no
further edits are made to this section.
Section 37.20 Miner Identification
Document
Section 37.20 requires the use of a
Miner Identification Document as a
component of the examination.
Although this section was not amended
by the August 2014 IFR, revising it here
is consistent with the addition of
spirometry to part 37, and is thus a
logical outgrowth of this rulemaking.
The text is revised slightly to reference
both radiographic and spirometry
examinations. The section is also
changed to clarify that the form (CDC/
NIOSH 2.9) is required for both types of
examination.
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Section 37.40 General Provisions
Section 37.40 outlines general
provisions for chest radiographs.
Paragraphs (a) and (c), which require
that the radiographic examination must
be given at a convenient time and place
and performed in an approved facility,
respectively, are unchanged. Paragraph
(b) is revised to update the name of the
completed form that must accompany
the chest radiographic examination, the
Chest Radiograph Classification Form
(CDC/NIOSH 2.8). No comments were
submitted on this section.
Section 37.43 Approval of
Radiographic Facilities That Use Film
Radiography Systems
Section 37.43 establishes standards
for the approval of radiography facilities
that use film. Although this section was
not included in the August 2014 IFR,
revisions are a logical outgrowth of
other changes throughout the part. The
section heading is revised to clarify that
it applies to film radiography systems.
Paragraph (a), concerning application to
NIOSH for facility participation in the
CWHSP, is unchanged except to divide
it into smaller paragraphs for clarity.
Paragraph (a)(1) concerns the
submission of sample radiographs made
on the equipment intended to be used
to perform radiographs under this part;
(a)(2) concerns the submission of
sample radiographs within 15 days of
being made; (a)(3) concerns the return of
such radiographs submitted as a
component of the A Reader approval
process. The reference provided for
those chest radiographs is corrected to
read § 37.52(a)(2)(i).
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The name of the form referenced in
paragraph (b), the Radiographic Facility
Certification Document, is updated to be
consistent with updates in other
sections of Part 37.
Paragraphs (c), (d), and (f), concerning
the evaluation of radiographs submitted
with applications for NIOSH approval,
the inspection of the applicant facility
by NIOSH, and the establishment of a
quality assurance program at the
applicant facility, respectively, are
unchanged.
The name of the form referenced in
paragraph (e), the Radiographic Facility
Certification Document, is updated to be
consistent with updates in other
sections of part 37. The paragraph is
also divided into smaller paragraphs for
clarity. Paragraph (e)(1) now concerns
the suspension or withdrawal of NIOSH
approval of a radiograph facility;
paragraph (e)(2) requires a copy of a
withdrawal notice be displayed on the
mine bulletin board.
In paragraph (g), concerning the
maintenance of records in accordance
with Federal privacy laws, the word
‘‘interpretations’’ is replaced with
‘‘classifications,’’ to clarify that B
Readers are responsible for recording
classifications on the Chest Radiograph
Classification Form (CDC/NIOSH 2.8).
The term ‘‘classifications’’ describes
surveillance activities, such as
providing standardized descriptions of
chest radiographs, while
‘‘interpretations’’ is a broader term
meant to describe clinical activities,
such as assessing radiographic findings
and generating radiological differential
diagnoses. This revision is consistent
with similar changes in other sections of
part 37.
Section 37.44 Approval of
Radiographic Facilities That Use Digital
Radiography Systems
Section 37.44 establishes standards
for the approval of radiography facilities
that use digital radiography. Although
this section was not included in the
August 2014 IFR, the new organization
and content revisions are a logical
outgrowth of other changes throughout
the part. Paragraph (a), concerning
application to NIOSH for facility
participation in the CWHSP, is
unchanged. Paragraph (a)(1), regarding
the submission of digital radiographic
image files with an application for
facility approval, is redesignated as
paragraph (a) and divided into smaller
paragraphs for clarity. Paragraph (a)(1)
now concerns the submission of image
files; (a)(2) concerns the submission of
images within 60 days of the application
date; (a)(3) concerns the documentation
that must accompany the image files;
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and (a)(4) concerns the orientation of
submitted images.
Paragraph (a)(2) is redesignated as
paragraph (b). The name of the form
referenced in paragraphs (b) and (e), the
Radiographic Facility Certification
Document, is updated to be consistent
with updates in other section of part 37;
similarly, the word ‘‘X-ray’’ is replaced
with ‘‘radiograph’’ in paragraph (g)(2).
Paragraphs (b), (c), (e), (f), and (h),
concerning facility licensure, physical
inspections by NIOSH, the medical
physicist requirement, documentation
of compliance, and maintenance of
records in accordance with Federal
privacy laws are redesignated as
paragraphs (c), (d), (e), (f), and (i),
respectively.
Paragraph (g)(2), regarding radiation
exposure parameters, is redesignated as
paragraph (h)(2) and is divided into
smaller paragraphs for clarity. Paragraph
(h)(2)(i) now concerns the monitoring of
radiological exposures; paragraph
(h)(2)(ii) now concerns annual
assessments of radiation exposures
conducted by a medical physicist. The
substance of paragraph (h) is otherwise
unchanged.
Section 37.50 Interpreting and
Classifying Chest Radiographs—Film
Radiography Systems
Section 37.50 establishes procedures
for the classification of film radiographs.
The section heading is revised to clarify
that the procedures herein apply
specifically to film radiography systems.
Paragraphs (a), which requires
radiographs to be interpreted in
accordance with the ILO Classification,
and (c), which requires those
interpreting chest radiographs to have a
complete set of standard radiographs for
use with the ILO Classification
immediately available for reference, are
unchanged.
Paragraph (b) requires radiographs to
be interpreted and classified by
physicians who read chest radiographs
in the normal course of practice and
who have demonstrated proficiency in
classifying pneumoconiosis in
accordance with the standards in
§ 37.52. Non-substantive revisions to the
regulatory text in paragraph (b)(1),
which requires that interpretations of
findings other than pneumoconiosis
must be provided by a qualified
physician who provides these services
for the examining facility, clarify that
the physician must have all required
licensure and privileges and must
interpret chest radiographs in the
normal course of his or her practice.
Paragraph (c), which requires all
interpreters to have immediately
available a set of standard radiographs
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for use with the ILO Classification, is
unchanged.
Paragraph (d), which establishes
standards for view boxes, is revised to
clarify that view boxes must comply
with the requirements in paragraphs
(d)(1)–(4). No comments were submitted
on this section.
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Section 37.51 Interpreting and
Classifying Chest Radiographs—Digital
Radiography Systems
Section 37.51 establishes procedures
for the classification of digital chest
radiographs. Paragraph (a), which
requires that significant abnormal
findings other than pneumoconiosis
must be initially interpreted and
notification provided by a qualified
physician, is not changed in this action.
Paragraph (b), requiring that
classifications be made by B Readers
and recorded on a Chest Radiograph
Classification form, is revised to clarify
that physician readers who have
demonstrated proficiency in the
classification of pneumoconiosis in
accordance with § 37.52(b) are B
Readers. The paragraph is also changed
to remove the term ‘‘interpretations,’’ for
the reasons discussed above.
Paragraph (c), which requires B
Readers to have a complete set of
NIOSH-approved standard digital
radiographs for use with the ILO
Classification immediately available for
reference, is changed to clarify that
NIOSH-approved digital standard
images used for making classifications
include all approved electronic standard
chest images, thus encompassing the
current digitized standard chest
radiographs provided by ILO. This
paragraph is also divided into smaller
paragraphs to aid the reader; no
substantive changes are made.
Paragraph (c)(1) now concerns the use of
only NIOSH-approved standard digital
images for classification; (c)(2) prohibits
the modification of the appearance of
the standard images.
Paragraphs (d) through (g), which
concern viewing systems, quality
control for display devices, use of soft
copy images, and the impermissibility
of classifications based on digitized
copies of chest radiographs are also
unchanged. No comments were
submitted on this section.
Section 37.52 Proficiency in the Use of
Systems for Classifying the
Pneumoconioses
Section 37.52 establishes the A and B
Reader approval programs. Paragraph (a)
establishes standards for the approval of
A Readers; paragraph (a)(1), which
allows A Reader approvals to continue
if established prior to October 15, 2012,
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is changed to clarify that the approval
continues indefinitely. Paragraph (a)(2)
details the requirements for becoming a
NIOSH-approved A Reader; paragraph
(i), which requires the submission of six
properly-classified sample radiographs,
is revised to remove the word
‘‘interpretations’’ and replace it with
‘‘classifications,’’ and to update the
name of the form to Chest Radiograph
Classification Form (CDC/NIOSH 2.8),
for the reasons discussed above.
Paragraph (a)(2)(ii), requiring the
completion of a NIOSH-approved ILO
Classification course in lieu of the six
sample radiographs referenced in
paragraph (a)(2)(i), is unchanged.
Paragraph (b), which establishes
standards for the approval of B Readers,
and paragraph (b)(1), which establishes
that B Reader approvals received prior
to October 1, 1976 are terminated, are
unchanged. Paragraph (b)(2) requires
that physicians pass a proficiency
examination in order to be approved as
a NIOSH B Reader and is revised to
clarify that B Reader proficiency
examinations are only given on behalf of
or by NIOSH. This paragraph is also
revised to divide the large paragraph
into smaller paragraphs; no substantive
revisions are made. Paragraph (b)(2)(i)
now concerns the provision of a
complete set of NIOSH-approved
standard reference digital radiographs to
physicians taking the B Reader exam;
(b)(2)(ii) states that physicians who
qualify as B Readers need not be
qualified as A Readers.
Paragraph (c) requires physicians who
wish to participate in the CWHSP to
apply to NIOSH. The name of the form
is changed to Physician Application for
Certification; the paragraph is otherwise
unchanged. No comments were
submitted on this section.
Section 37.53 Method of Obtaining
Definitive Chest Radiograph
Classifications
Section 37.53 establishes the method
used by NIOSH to obtain definitive
classifications of chest radiographs. For
the reasons discussed above, the name
of this section is revised to replace
‘‘interpretations’’ with ‘‘chest
radiograph classifications,’’ to clarify
that B Readers provide classifications
according to the ILO system for
classifying radiographs. Paragraph (a)
establishes that radiographs will be
independently classified by an A Reader
and B Reader or two B Readers, or if
agreement is lacking, NIOSH will obtain
a third classification. This paragraph is
revised to clarify that B Readers are
qualified by NIOSH pursuant to § 37.52,
and is also divided into smaller
paragraphs to aid the reader. Paragraph
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(a)(1) now concerns agreement among
the two classifications; (a)(2) concerns
the procedure NIOSH follows when
agreement is lacking, and is further
divided into smaller paragraphs.
Paragraph (a)(2)(i) concerns agreement
between two of three classifications
resulting in a final determination;
(a)(2)(ii) concerns lack of agreement
among three classifications. No other
changes are made to this paragraph.
Paragraph (b), which establishes what
NIOSH considers to be agreement
between chest radiographs, is revised to
clarify that two classifications are
considered to be in agreement when
they meet the standards now in
paragraphs (b)(1), (2), and (3). Paragraph
(b)(3), which contains the current
standard for a determination of simple
pneumoconiosis, is further divided into
smaller paragraphs (i) and (ii) and is
revised slightly to comport with the new
structure. No comments were submitted
on this section.
Section 37.54 Notification of
Abnormal Radiographic Findings
Section 37.54 requires that findings of
abnormalities identified by chest
radiograph be communicated to the
miner. Although this section was not
included in the August 2014 IFR, the
revisions discussed below are consistent
with other changes in this final action.
A new heading is added to clarify the
intent of paragraph (a), which provides
that findings suggesting heart
abnormalities, tuberculosis, lung cancer,
or any other significant health condition
other than pneumoconiosis must be
communicated to the miner or the
miner’s designated physician. The
paragraph is also rearranged to clarify
that the first physician to interpret a
miner’s radiograph must communicate
the findings.
A new heading is added to clarify the
intent of paragraph (b), which provides
that NIOSH will arrange for a physician
to compare a recent radiograph found to
show significant abnormal findings,
including pneumoconiosis, with older
images that NIOSH may have in its
possession. The word ‘‘interpretation’’
is removed from this paragraph to
clarify that NIOSH will arrange for a
physician to compare the most recent
image showing an abnormality to older
images. This change is consistent with
other similar changes throughout part
37, for the reasons discussed above.
A new heading is added to paragraph
(c), to clarify the intent of the paragraph
regarding notice to the miner of
eligibility for Part 90 transfer rights. The
term ‘‘final findings’’ is replaced with
‘‘final determinations,’’ which are
reported to the miner or the miner’s
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designated physician by NIOSH, when
such determinations provide evidence
for the development of pneumoconiosis.
Revisions also clarify that NIOSH will
coordinate with MSHA regarding
notification of part 90 eligibility.
Finally, a heading is added to clarify
the intent of paragraph (d), which states
that NIOSH makes every effort to
process pneumoconiosis determinations
within 60 days of receipt of chest
radiograph images and other
documents. The paragraph is also
divided into smaller paragraphs to aid
the reader. Paragraph (d)(1) now
concerns timely notice by MSHA; this
paragraph is revised to clarify that
NIOSH will work with MSHA to
provide notice within the 60-day
timeframe established in paragraph (d).
Paragraph (d)(2) now states that
examination results may not be
processed by NIOSH if the examination
was made within 6 months of the date
of a prior acceptable examination.
One public commenter recommended
that this section be changed to allow the
results of the radiography examinations
and spirometry to be made available to
a health professional designated by the
mine operator. According to the
commenter, because operators are
required to establish a plan for the
examinations and pay for them, they are
entitled to have access to the results.
The commenter argued that section 203
of the Mine Act (30 U.S.C. 843) does not
support excluding mine operators from
the notification requirements in this
section or in the spirometry results
notification requirements in the new
§ 37.97. According to the commenter,
the decision to not provide examination
results to mine operators is inconsistent
with a 2006 NIOSH guidance document
concerning refractory ceramic fibers and
with the DOL Occupational Safety and
Health Administration (OSHA) asbestos
standards, both of which allow
notification of employers. Further,
according to the commenter, section
103(h) of the Mine Act provides for the
sharing of reports and findings to any
interested person. Finally, the
commenter argued that sharing the
examination findings with operators
would allow the operators to provide
health counseling and medical
management to miners showing
evidence of early disease.
NIOSH declines to make results of
radiography or spirometry available to
either mine operators or health
professionals designated by operators.
Section 203 of the Mine Act specifically
identifies the parties that must be
notified of examination results (i.e.,
Secretary, DOL; Secretary, HHS; miner;
and miner’s designated physician).
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NIOSH is not authorized to expand
notification to mine operators. Section
103 of the Mine Act, referenced by the
commenter and described above, is not
relevant to the matter of medical
examinations of individual miners
because it only addresses the conduct of
mine inspections. Finally, NIOSH
concurs with MSHA in its response to
the question of providing examination
results to operators, published in
MSHA’s 2014 final rule on respirable
coal mine dust, which explained that
the individuals notified of the miner’s
test results are limited in order to
protect miners’ confidentiality and
uphold Federal privacy laws.5
Section 37.60 Submitting Required
Chest Radiographs and Miner
Identification Documents
Section 37.60 establishes the protocol
for submitting radiographs to NIOSH.
Paragraph (a) is revised to clarify that all
submitted items, including each
required chest radiograph, the Chest
Radiograph Classification form, and the
Miner Identification Document, become
the property of NIOSH. Paragraph (a)(1)
is further revised to remove the
redundant sentence concerning the 14day deadline for submission of
documents after the date of the
radiographic examination. The sentence
concerning NIOSH’s notification to the
submitting facility of receipt of image
files and forms is moved into paragraph
(a)(2).
Paragraph (b) is revised to clarify that
the operator must arrange for
reexamination at no expense to the
miner, in the event that NIOSH finds
any submission to be inadequate.
Paragraph (c), which establishes that
failure to comply with paragraph (a) or
(b) may result in revocation of approval
of a plan, is unchanged, as is paragraph
(d), which states that chest radiographs
and required forms must only be
submitted for miners.
Paragraph (e) is revised to replace
‘‘shall’’ with ‘‘must’’ or ‘‘will’’
throughout the paragraph in accordance
with Federal plain language guidelines.
References in this paragraph concerning
the collection of Social Security
numbers are revised slightly to clarify
that only the last four digits are required
by NIOSH; this change is not
substantive and reflects current Program
practice. No comments were submitted
on this section.
Section 37.70 Review of
Classifications
Section 37.70(a) establishes that a
miner may request that NIOSH
5 See
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reevaluate a pneumoconiosis
classification that the miner believes is
in error. The section heading is changed
to replace ‘‘interpretations’’ with
‘‘classifications,’’ consistent with
previous edits discussed above. The
paragraph is also divided into smaller
paragraphs to aid the reader. Paragraph
(a)(1) establishes that after a written
request from a miner, NIOSH will obtain
one or more additional classifications by
B Readers if the contested classification
was based on agreement between an A
Reader and a B Reader, pursuant to
§ 37.53. A reference in this paragraph to
the section in part 37 that addresses the
transfer of miners to a less dusty area is
corrected to read § 37.102. Paragraph
(a)(2) establishes that a classification
based on agreement between two or
more B Readers will be considered final
and will be not be reevaluated. No
comments were submitted on this
section and no other changes are made
to the regulatory text.
§ 37.80 Availability of Records for
Radiographs
Section 37.80 requires that written
consent be provided to NIOSH for the
release of medical information and
radiographs. This section was not
included in the August 2014 IFR, but is
revised in this final action to clarify that
original film radiographs are available
for examination at the NIOSH facility in
Morgantown, WV. No comments were
submitted on this section.
B. Subpart—Spirometry Testing
This subpart establishes standards for
spirometry testing for all coal miners,
working in both underground and
surface mines. As discussed in the
August 2014 IFR, the provisions in this
subpart are consistent with MSHA
regulations in 30 CFR 72.100, which
requires that operators offer periodic
spirometry and respiratory assessments
to document miner respiratory
symptoms and lung function. This is in
addition to chest radiographic
examinations and occupational history
questionnaires. The subpart heading is
revised to replace the word
‘‘examinations’’ with the word
‘‘testing,’’ and similar changes are made
throughout the subpart to reflect the
correct terminology for describing
spirometry.
Section 37.90
Scope
Section 37.90 provides the scope of
the provisions in Subpart—Spirometry
Testing. The text of this section is
changed slightly to clarify that operators
are required to provide spirometry
testing to both current and newly
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employed coal miners. No comments
were submitted on this section.
Section 37.91
Definitions
Section 37.91 defines terms used in
this subpart. Several revisions are made
to this section. The definition ‘‘facility’’
is removed, unchanged, from this
section and moved to the definitions
section in § 37.2.
The definition ‘‘FET’’ is revised to
clarify that forced expiratory time is the
time from the beginning of a forced
exhalation maneuver to the end of the
expiration.
The definition ‘‘FEV1’’ is revised to
clarify that forced expiratory volume in
one second is the greatest volume of air
that can be forcibly blown out within
the first second after full inspiration.
A new definition of the FEV1/FVC is
added to mean the ratio between the
largest acceptable FEV1 and the largest
acceptable FVC following the forced
vital capacity maneuver.6 Although this
definition was not included in the
August 2014 IFR, it is considered to be
a logical outgrowth of this rulemaking.
(See § 37.96(b)(1).)
The existing definition of ‘‘FEV6’’ is
revised to clarify that forced expiratory
volume in six seconds is the greatest
volume of air that can forcibly be blown
out in six seconds after full inspiration.
The existing definition of ‘‘FVC’’ is
revised to clarify that forced vital
capacity is the greatest volume of air
that can forcibly be blown out after full
inspiration.
The existing definition of ‘‘PEF’’ is
revised to clarify that peak expiratory
flow is the maximal airflow generated
during a forced vital capacity maneuver.
No comments were submitted on this
section.
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Section 37.92 Spirometry Testing
Required for Miners
Section 37.92 requires coal mine
operators to provide all miners an
opportunity to receive spirometry
testing. Paragraph (a), which requires
that each operator must provide an
opportunity for miners to perform
spirometry testing at least once every 5
years, is unchanged except for the
heading, in which ‘‘Voluntary
examinations’’ is replaced with
‘‘Voluntary tests.’’
Paragraphs (b)(1), (2), and (3) establish
the periodicity of initial, second, and
third spirometry tests. The headings for
the lower subparagraphs, ‘‘Initial
spirometry examination,’’ ‘‘Second
examination,’’ and ‘‘Third examination’’
6 See Gregg L. Ruppel, Manual of Pulmonary
Function Testing, 51 (St. Louis: Mosby Inc., 9th ed.,
2009).
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are removed to mirror the structure of
§ 37.3, ‘‘Chest radiographs required for
miners.’’ The word ‘‘examination(s)’’ is
replaced with ‘‘test(s)’’ throughout all
three. Paragraph (b)(3) is revised to
clarify that a third spirometry test and
respiratory assessment will be provided
if the second spirometry test results
demonstrate more than a 15 percent age
adjusted decline in the percent
predicted FEV1 value since the initial
baseline test. This paragraph is also
divided into smaller paragraphs to aid
the reader; the two new sub-paragraphs
clarify how the percent predicted FEV1
value will be calculated (paragraph
(b)(3)(i)) and the appropriate correction
factor for calculating the percent
predicted FEV1 for an individual of
Asian descent (paragraph (b)(3)(ii)). One
comment was received on paragraph
(b)(3), supporting the decision to
establish the 15 percent decline in the
percent predicted FEV1 value.
Paragraph (c) establishes notification
requirements for second and third
spirometry testing sessions. This
paragraph is also divided into smaller
paragraphs to aid the reader. Paragraph
(c)(1) stipulates that the operator would
be notified of a miner’s eligibility for a
third spirometry test only with the
consent of the miner. If the operator is
notified, NIOSH will not specify the
medical reason for the third test nor
reveal that it is the miner’s third.
Paragraph (c)(2) establishes that if the
miner is notified of the time for a third
test and the operator is not notified,
provision for the test in the NIOSHapproved operator’s plan will constitute
the operator’s compliance with this
requirement; no changes are made to the
text of this paragraph.
No revisions are made to paragraph
(d) and no other public comment was
received on this section.
Section 37.93 Approval of Spirometry
Facilities
Section 37.93 establishes standards by
which NIOSH approves facilities that
conduct spirometry tests, including
ensuring that spirometry results are of
adequate quality, and specifying
programmatic approaches to quality
assurance and addressing deficiencies.
Paragraph (a) requires that NIOSHapproved facilities be able to provide
spirometry of high technical quality by
meeting the standards in this subpart.
The paragraph is revised to replace the
term ‘‘spirometry examinations’’ with
the more common ‘‘spirometry testing,’’
and to remove the link to the
Spirometry Facility Certification
Document to avoid incorrect
information if the NIOSH Web site is
updated.
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Paragraph (b) establishes that a
spirometry quality assurance program
must be in place at the facility to
minimize the rate of invalid test results.
Paragraph (b)(1) requires instrument
calibration checks, performed in
accordance with the 2005 ATS/ERS
Standardisation of Spirometry
guidelines. The regulatory text is
revised to clarify that instrument
calibration check records must be
maintained by the facility and available
for inspection by NIOSH, as deemed
necessary. One public commenter stated
that the calibration check procedures as
described in the proposed rule were
most relevant to volume spirometers,
which are no longer being produced and
are increasingly unavailable for
purchase. In response to the public
comment, the regulatory text in
paragraph (b)(1) is revised and divided
into smaller paragraphs to clarify which
calibration check procedures are
expected for volume spirometers
(paragraph (b)(1)(i)) and flow-type
spirometers (paragraph (b)(2)(ii)). These
procedures are consistent with guidance
cited by the commenter and published
by the Occupational Safety and Health
Administration.7 A new paragraph
(b)(1)(iii) contains the existing sentence
regarding the retention and maintenance
of instrument calibration check records,
and is changed to clarify that records
will be available for inspection by
NIOSH, as deemed necessary.
Paragraph (b)(2) requires automated
maneuver and test session qualitychecks. The paragraph is revised to
clarify that the screen displayed error
messages must alert the technician to
maneuver acceptability and test session
non-repeatability. The paragraph is also
revised to clarify that each spirometry
test session must have the goal of
obtaining 3 acceptable with 2 repeatable
forced vital capacity maneuvers. A
public commenter also expressed
concern that technicians understand
that although the error messages
referenced in paragraph (b)(2) are
helpful, they are unreliable and cannot
be relied on alone to evaluate and
determine test validity. NIOSH agrees
that technicians should not rely on the
equipment alone to alert them of testing
errors. Accordingly, § 37.95(a) requires
all providers who collect spirometry
data to successfully complete a NIOSHapproved spirometry training course.
The spirometry course curriculum
includes the identification and
7 Occupational Safety and Health Administration,
U.S. Department of Labor, Spirometry Testing in
Occupational Health Programs: Best Practices for
Healthcare Professionals, OSHA 3637–03 2013,
https://www.osha.gov/Publications/OSHA3637.pdf.
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correction of technical and subject
performance errors.8 Course participants
are given additional curriculum
materials to use as guides for correcting
these testing errors, which they can
retain for future reference in their
clinics.9 Paragraph (b)(2) is not changed
in response to the public comment.
Paragraph (b)(3) requires ongoing
monitoring of spirometry test quality.
The paragraph is revised to clarify that
NIOSH may provide quality
performance feedback to the spirometry
technician(s). The word ‘‘examination,’’
used to characterize spirometry data, is
removed from paragraph (b)(4), which
concerns quality assurance audits.
The word ‘‘as’’ is inserted into
paragraph (c), which concerns
noncompliance, to improve the first
sentence; the word ‘‘examination’’ is
removed, for the reasons discussed
above. Paragraph (d), revocation of
approval, is unchanged.
Finally, in paragraph (e), references to
chest radiographs are removed and/or
changed to reference spirometry tests, in
keeping with the theme of this subpart.
These changes include replacing the
term ’’medical examinations’’ with
‘‘spirometry tests’’ and removing the
reference to radiograph examinations,
classifications, and images.
Section 37.94 Respiratory assessment
form
Section 37.94 requires that a
respiratory assessment form must be
completed for each miner upon testing.
The link to the form on the NIOSH Web
site is removed and the word
‘‘examination’’ is replaced with
‘‘testing.’’ No comments were submitted
on this section.
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Section 37.95 Specifications for
Performing Spirometry Tests
Section 37.95 establishes standards
for the performance of spirometry tests;
the term ‘‘examinations’’ is replaced
with ‘‘tests’’ in the section heading.
Paragraph (a) of this section requires
that persons administering spirometry
tests for the CWHSP demonstrate
completion of NIOSH-approved
spirometry training, and maintain their
knowledge by periodically completing
an approved refresher course. The
paragraph is revised to remove the link
8 See Spirometry: What is the Design and Content
of an Approved Course? https://www.cdc.gov/niosh/
topics/spirometry/content-approved-course.html.
9 See NIOSH, Get Valid Spirometry Results
EVERY Time, DHHS (NIOSH) Publication No.
2011–135, March 2011, https://www.cdc.gov/niosh/
docs/2011-135/, and NIOSH, Spirometry Quality
Assurance: Common Errors and Their Impact on
Test Results, DHHS (NIOSH) Publication Number
2012–116, January 2012, https://www.cdc.gov/niosh/
docs/2012-116/default.html.
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to the Spirometry Results Notification
Form.
Paragraph (b) establishes
specifications for the spirometry testing
equipment used to conduct tests
pursuant to this Part. A public
commenter recommended that the realtime displays should be large in order
to allow the technician to quickly
identify issues with the tests. NIOSH
agrees with the commenter’s concern
and has required that spirometry testing
equipment conform with the 2005 ATS/
ERS Standardisation of Spirometry
specifications for graphics (real-time
displays and test reports), which should
be a minimum size for the proper
recognition of errors and acceptability of
test maneuvers. As part of the approval
process, clinics are required to provide
information pertaining to spirometer
manufacturer, model, and serial number
for each spirometer used during miner
testing. This spirometer information
allows NIOSH to confirm that the
system display meets minimum
requirements. No changes are made to
paragraph (b).
Paragraph (c) specifies certain
required documents and procedures
during performance of spirometry
testing, including the pre-test checklist,
Respiratory Assessment form, collection
of anthropometric and demographic
information, and the spirometry
procedure itself, which must be
conducted in accordance with testing
procedures described in the 2005 ATS/
ERS Standardisation of Spirometry and
the 2010 Standardisation of Lung
Function Testing, authors’ replies to
readers’ comments, which are
incorporated by reference. The
paragraph is revised to include a new
paragraph (c)(1), which clarifies that the
Miner Identification Document
described in § 37.20 must be completed
for each miner at the facility where
spirometry is performed; the remaining
numbered paragraphs are re-numbered
accordingly. In the paragraphs now
designated (c)(2) and (3), which require
completion of the pre-test checklist and
the Respiratory Assessment form,
respectively, the links to those
documents are removed, for the reason
discussed above. Paragraph (c)(4),
which requires the collection of
anthropometric and demographic
information, is revised to clarify that the
data must either be entered into the
facility’s computer and transmitted
electronically with the spirometry data
file or submitted, if required under the
facility’s approval, on the Spirometry
Results Notification form. Language
concerning spirometry equipment that
does not permit electronic transfer of
data files is removed because all
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facilities that are approved to participate
in the CWHSP will submit spirometry
data electronically, whether in the form
of spirometry data files or in the form
of a completed Spirometry Results
Notification Form (CDC/NIOSH 2.15)
accompanied by a spirometry report
PDF that contains graphics for NIOSH
inspection of FVC maneuver quality.
The paragraph (c)(5) heading is revised
to clarify that the topic of the paragraph
is test procedures.
Paragraph (d), concerning the
submission of test results by the
approved facility to NIOSH, is removed
because it is redundant. Requirements
for the submission of spirometry results
to NIOSH are consolidated in § 37.96(c).
No changes are made to former
paragraph (e), now designated
paragraph (d), concerning records
retention, other than to substitute ‘‘test’’
and ‘‘sessions’’ for ‘‘examination’’ and
‘‘examinations,’’ and no other public
comments were received on this section.
Section 37.96 Spirometry
Interpretations, Reports, and
Submission
Section 37.96 establishes
requirements for the interpretation of
spirometry test results, as well as
specifications for the content, deletion,
and transmission of test reports. The
heading of this section is revised to
replace the word ‘‘notifications’’ with
‘‘submission’’ to reflect a reorganization
of this section, discussed below.
Paragraph (a) of this section requires
qualified health care professionals at the
facilities to interpret results using a
standardized approach, described in the
2005 ATS/ERS Interpretative Strategies
for Lung Function Tests, and the 2014
Official ATS Standards: Spirometry in
the Occupational Setting, which are
incorporated by reference. No changes
are made to paragraph (a).
Paragraph (b) specifies the content of
spirometry test reports and the deletion
of files and forms associated with the
testing. The title of paragraph (b) is
edited for clarity, ‘‘Spirometry reports at
NIOSH-approved spirometry facilities.’’
The phrase ‘‘at a minimum’’ is removed
from paragraph (b)(1) to clarify that
spirometry reports must contain the
elements listed in this paragraph.
Paragraph (b)(1) is also divided into
smaller paragraphs to clarify the
required elements, and revised by
adding the word ‘‘threshold’’ to describe
the lower limit of normal values
required. Paragraph (b)(2) is unchanged.
The language in paragraph (c), which
requires that findings are communicated
to the miner or the miner’s designated
physician, is moved from § 37.96 to a
new § 37.97; the existing section
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containing references to documents
incorporated by reference into this
subpart is renumbered § 37.98. The
notifications to miners section, public
comment, and NIOSH response to
comment are discussed below.
With the removal of the language in
paragraph (c), paragraph (d), concerning
the submission of spirometry results to
NIOSH, is redesignated paragraph (c).
The text in this paragraph is revised to
clarify that each facility must submit
spirometry results and completed forms
to NIOSH within 14 days of a
spirometry test. The link to the
Spirometry Notification Form is
removed, as discussed above, and the
name of the form is corrected. This
paragraph is divided into smaller
paragraphs to aid clarity. Paragraph
(c)(1) concerns the submission of
spirometry test results in the form of an
electronic data file. CWHSP prefers the
submission of all test results and data
points using CSV or XML files. The
submission must be carried out as
specified in the facility’s approval.
Paragraph (c)(2) allows the submission
of test results electronically using the
Spirometry Results Notification form,
when specified under a facility’s
approval. Electronic submission of test
results via ePDF is acceptable when
facilities are otherwise unable to submit
electronic files in CSV or XML format.
These changes are not substantive.
The final paragraph, concerning the
confidentiality of test results, is
redesignated paragraph (d). The word
‘‘examinations’’ is removed from the
paragraph heading. The text in this
paragraph is revised to clarify that
medical records containing protected
health information must be maintained
pursuant to the requirements in
§ 37.93(e). Finally, paragraph (d) is
divided into two smaller paragraphs for
clarity. No public comment was
received on this section.
Section 37.97 Notification of
Spirometry Results
New § 37.97, concerning the
notification to miners or the miner’s
designated physician of spirometry
results, comprises text that was located
in § 37.96(c). It is moved to a new
section to make information about
notification procedures more accessible
and to mirror the structure of the
subpart concerning chest radiographs.
The original text is revised slightly to
clarify that a comparison between
current and previously submitted
spirometry tests will be provided by
NIOSH to the miner if the results from
more than one set of spirometry results
are available. One public commenter
recommended that the results of both
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radiography and spirometry be made
available to a health professional
designated by the mine operator. NIOSH
declines to adopt this recommendation;
a summary of the public comment and
NIOSH’s response is located above, in
the discussion concerning § 37.54.
Section 37.98
by Reference
Standards Incorporated
Existing § 37.97, concerning standards
incorporated by reference into this
subpart, is redesignated § 37.98.
Paragraph (a) is revised to update the
name of the NIOSH Respiratory Health
Division, as discussed above. The link
to the ATS Standardization of
Spirometry; 1994 Update, is updated, as
is the link to the 2005 ATS/ERS
Standardisation of Spirometry. No
comments were submitted on this
section.
C. Subpart—General Requirements
This subpart establishes general
requirements for all surface and
underground coal mine operators.
Section 37.100 Coal Mine Operator
Plan for Medical Examinations
Section 37.100 requires that all coal
mine operators submit a plan for
providing miners with radiography and
spirometry examinations. Paragraph (a)
requires operators to submit and receive
NIOSH approval for a plan to provide
the examinations, as well as
occupational histories and respiratory
assessments; it is unchanged. Paragraph
(a)(1) specifies that on or after August 1,
2014, a person becoming a coal mine
operator, for example by purchasing an
existing mine or developing a new
mine, or a mine operator without an
approved plan must submit a plan
within 60 days that provides for chest
radiographs and occupational histories.
The paragraph is revised, inserting the
word ‘‘only,’’ to clarify that the
provision of spirometry tests need not
be included for a plan approved
pursuant to this paragraph.
Paragraph (a)(2) states that all
operators with approved examination
plans providing only for chest
radiographs and occupational histories
will be notified by MSHA when they are
required to submit an amended plan
that includes spirometry and respiratory
assessments.
In paragraph (b), which lists the
required components of the operator’s
plan, the term ‘‘X-ray’’ is replaced with
‘‘radiograph’’ and ‘‘tests’’ are replaced
with ‘‘examinations’’ in paragraph
(b)(4); ‘‘shall’’ is replaced with ‘‘must’’
or ‘‘will’’ in paragraph (b)(5) in
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accordance with the Federal Plain
Language Guidelines.10
Paragraph (c), which allows operators
to provide for alternate examination
facilities, is revised to clarify that the
alternate facilities should be identified
in the operator’s plans submitted to
NIOSH for approval.
‘‘Shall’’ is also replaced by ‘‘must’’
and ‘‘shall be’’ is replaced with ‘‘is’’ in
paragraph (d), which states that an
approved plan remains in effect even
when the mine operator has transferred
responsibility for the mine to a new
operator.
Paragraph (e), concerning changes in
mine plans, is unchanged. Paragraph (f),
which requires the display of a
proposed plan or a proposed change in
plan, is revised slightly to clarify that
only changes to a NIOSH-approved plan
need be displayed.
In paragraph (g), which requires that
mine operators resubmit a plan for each
mine upon notification from NIOSH, the
word ‘‘will’’ is replaced with ‘‘must’’ in
accordance with Federal Plain Language
Guidelines.
No public comment was received and
no other changes are made to this
section.
Section 37.101
Approval of Plans
Section 37.101 establishes that the
operator’s plan will be approved by
NIOSH if it is found to meet the
requirements in this subpart. Paragraphs
(a) and (b), concerning approval and
denial of mine operator plans, are
unchanged. Paragraph (c) is revised to
clarify that NIOSH will inform MSHA if
an operator’s plan is denied, in addition
to the existing requirement for NIOSH to
inform the operator. No comments were
submitted on this section.
Section 37.102 Transfer of Affected
Miner to Less Dusty Area
Section 37.102 requires that any
miner who has evidence of the
development of pneumoconiosis, as
determined by NIOSH, must be given
the option of transferring to a less dusty
area of the mine. A public commenter
recommended that transfer to a less
dusty area should be mandatory for all
miners with ILO classifications greater
than or equal to category 2. According
to the commenter, only 19 percent of
over 3,000 miners who were offered an
opportunity to transfer to a less dusty
area since 1980 have exercised that
option. Thus, the commenter thinks that
the intervention program is ineffective
‘‘in preventing pulmonary function
10 See Federal Plain Language Guidelines, https://
www.plainlanguage.gov/howto/guidelines/
FederalPLGuidelines/index.cfm.
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loss,’’ and that ‘‘stronger measures must
be put in place to increase the
participation in the transfer option.’’
NIOSH cannot require transfer of a
miner who demonstrates evidence of
development of pneumoconiosis to a
less dusty area. NIOSH concurs with
MSHA’s position, as addressed in the
agency’s May 1, 2014 final rule, that a
mandatory transfer program would
compromise the confidentiality of the
CWHSP. In addition, section 203 of the
Mine Act (30 U.S.C. 843) only speaks of
optional transfers, and does not
authorize mandatory transfers. No
additional public comment was
received, and no changes are made to
the regulatory text.
Section 37.103 Medical Examinations
at Miner’s Expense
Section 37.103 states that any miner
who wishes to obtain a radiography
examination or spirometry test at his or
her own expense may do so. For clarity,
the word ‘‘interpretation’’ is replaced
with ‘‘evaluation of spirometry test
results.’’ No public comment was
received on this section.
sradovich on DSK3GMQ082PROD with RULES3
General
One commenter asserted that NIOSH
must take into account the effects of
cigarette smoking on the health
outcomes of coal miners, particularly
chronic obstructive pulmonary disease
(COPD). The commenter referred to a
1995 NIOSH Criteria Document
concerning occupational exposure to
respirable coal mine dust, which
recommended that underground and
surface coal mine operators prohibit
smoking in all mines and other work
areas associated with mining, provide
counseling to smokers about their
increased risk of lung cancer and COPD,
and encourage them to participate in a
smoking cessation program.11
NIOSH acknowledges the effects of
smoking and dust exposure on the
development of occupational respiratory
disease. Accordingly, NIOSH uses the
Respiratory Assessment Form (CDC/
NIOSH 2.13) in the course of conducting
a spirometry test; the form includes
detailed questions designed to establish
the miner’s smoking history.12 At the
population level, this data collection
will allow NIOSH to take smoking into
account in evaluations of coal miners’
respiratory health and will assist NIOSH
in developing interventions to benefit
underground and surface coal miners.
At the level of the individual miner, the
11 National Institute for Occupational Safety and
Health, HHS, Criteria for a Recommended
Standard: Occupational Exposure to Respirable
Coal Mine Dust, DHHS (NIOSH) Publication No.
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goal of the radiography and spirometry
conducted pursuant to part 37 is to
identify radiographic evidence of
pneumoconiosis and spirometric
evidence of respiratory impairment, not
to establish disease causation.
NIOSH lacks authority to prohibit
smoking in underground and surface
coal mines, but includes information
about health effects of smoking in
notifications to individual miners.
Fortunately, many mines prohibit
smoking onsite.
IV. Regulatory Assessment
Requirements
A. Executive Order 12866 and Executive
Order 13563
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). E.O. 13563 emphasizes the
importance of quantifying both costs
and benefits, of reducing costs, of
harmonizing rules, and of promoting
flexibility.
This final rule is not being treated as
a ‘‘significant’’ action under E.O. 12866.
It finalizes and makes non-substantive
revisions to those sections in 42 CFR
part 37 which added requirements for
mine operators to provide symptom
assessment and spirometry testing for
the surveillance of decreased lung
function to all coal miners, and
extended existing requirements to
provide chest X-rays and occupational
histories for underground coal miners to
surface coal mine operators. The nonsubstantive revisions made in this final
action to those sections of 42 CFR part
37 that were promulgated by interim
final rule in August 2014 (79 FR 45110)
will not result in costs to either the
agency or its stakeholders.
The rule does not interfere with State,
local, or Tribal governments in the
exercise of their governmental
functions.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., requires each
agency to consider the potential impact
of its regulations on small entities
including small businesses, small
governmental units, and small not-forprofit organizations. This rule
95–106, September 1995, https://www.cdc.gov/
niosh/docs/95-106/pdfs/95-106.pdf.
12 See Respiratory Assessment Form (CDC/NIOSH
2.13), questions 9, 9a, 9b, 9c, 9d, 10, 11, https://
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establishes requirements for the
provision of chest X-rays and
spirometry tests to all coal miners, and
sets standards for the approval of testing
facilities and transmission of test data.
The potential impact on small
businesses has been analyzed by MSHA,
in the Regulatory Economic Analysis
published in support of that agency’s
May 1, 2014 final rule (see https://
www.msha.gov/REGS/REA/
CoalMineDust2010.pdf). This final rule
does not impose any new requirements
on small radiographic or spirometry
facilities that participate in the Coal
Workers’ Health Surveillance Program
administered by NIOSH under 42 CFR
part 37. This final rule will not impose
a significant economic burden on small
coal mines. Accordingly, HHS certifies
that this rule will not have a significant
economic impact on a substantial
number of small entities within the
meaning of the RFA.
C. Paperwork Reduction Act
The Paperwork Reduction Act, 44
U.S.C. 3501 et seq., requires an agency
to invite public comment on, and to
obtain OMB approval of, any regulation
that requires 10 or more people to report
information to the agency or to keep
certain records. This final action
continues to impose the same
information collection requirements as
under the August 2014 IFR, including
the submission of the following forms:
• Consent, Release, and History Form
for Autopsy [CDC/NIOSH (M)2.6]
• Chest Radiograph Classification Form
[CDC/NIOSH 2.8]
• Miner Identification Document [CDC/
NIOSH 2.9]
• Coal Mine Operator’s Plan [CDC/
NIOSH (M)2.10]
• Radiographic Facility Certification
Document [CDC/NIOSH (M)2.11(E)]
• Physician Application for
Certification [CDC 2.12 (E)]
• Respiratory Assessment Form [CDC/
NIOSH 2.13]
• Spirometry Facility Certification
[CDC/NIOSH 2.14]
• Spirometry Results Notification Form
[CDC/NIOSH 2.15]
• Coal Contractor Plan [CDC/NIOSH
(M) 2.18 (E)]
These forms are approved by OMB for
data collected under the National Coal
Workers’ Health Surveillance Program
(CWHSP) (OMB Control No. 0920–0020,
expires June 30, 2018). HHS estimates
that the paperwork burden associated
with this rulemaking is 20,282 hours.
www.cdc.gov/niosh/topics/surveillance/pdfs/
cwhsp-respiratoryassessment-2-13.pdf.
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Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(in hours)
Total burden
hours
Type of respondent
Form name
Coal Mine Operator .........................................
Coal Mine Contractor ......................................
Radiograph Facility Supervisor .......................
Coal Miner .......................................................
Coal Miner—Radiograph .................................
B Reader Physician .........................................
Physicians taking the B Reader Examination
Spirometry Facility Supervisor .........................
Spirometry Facility Employee ..........................
Spirometry Technician .....................................
Coal Mine—Spirometry ...................................
Pathologist .......................................................
Pathologist .......................................................
388
575
40
14,560
14,560
10
100
100
14,560
14,560
14,560
5
5
1
1
1
1
1
3014
1
1
1
1
1
1
1
30/60
30/60
30/60
20/60
15/60
3/60
10/60
30/60
5/60
20/60
15/60
5/60
5/60
194
288
20
4,854
3,640
1,507
17
50
1,214
4,854
3,640
1
1
Next-of-kin for deceased miner .......................
2.10 ....................................
2.18 ....................................
2.11 ....................................
2.9 ......................................
No form required ...............
2.8 ......................................
2.12 ....................................
2.14 ....................................
2.13 ....................................
2.15 ....................................
No form required ...............
Invoice—No standard form
Pathology Report—No
standard form.
2.6 ......................................
5
1
15/60
2
Total ..........................................................
............................................
........................
........................
........................
20,282
D. Small Business Regulatory
Enforcement Fairness Act
has been reviewed carefully to eliminate
drafting errors and ambiguities.
the Federal Plain Writing Act
guidelines.
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.
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.’’
List of Subjects in 42 CFR Part 37
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.
sradovich on DSK3GMQ082PROD with RULES3
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
classifications that result in a finding of
pneumoconiosis may be an element in
claim processing and adjudication
conducted by DOL’s Black Lung
Compensation Program. This final
action affects radiographs submitted to
DOL for the purpose of reviewing and
administering those claims. This rule
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H. Executive Order 13045 (Protection of
Children From Environmental Health
Risks and Safety Risks)
In accordance with Executive Order
13045, HHS has evaluated the
environmental health and safety effects
of this rule on children. HHS has
determined that the rule would have no
effect on children.
I. Executive Order 13211 (Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use)
In accordance with Executive Order
13211, HHS has evaluated the effects of
this rule on energy supply, distribution
or use, and has determined that the rule
will not have a significant adverse
effect.
J. Plain Writing Act of 2010
Under Public Law 111–274 (October
13, 2010), executive Departments and
Agencies are required to use plain
language in documents that explain to
the public how to comply with a
requirement the Federal government
administers or enforces. HHS has
attempted to use plain language in
drafting this final action consistent with
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Chronic obstructive pulmonary
disease, Coal workers’ pneumoconiosis,
Incorporation by reference, Lung
diseases, Mine safety and health,
Occupational safety and health,
Pneumoconiosis, Respiratory and
pulmonary diseases, Silicosis,
Spirometry, Surface coal mining,
Transfer rights, Underground coal
mining, X-rays.
Text of the Rule
For the reasons discussed in the
preamble, the Department of Health and
Human Services amends 42 CFR part 37
as follows:
PART 37—SPECIFICATIONS FOR
MEDICAL EXAMINATIONS OF 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.
2. Amend § 37.2 by revising the
introductory text and the definitions of
‘‘Act’’, ‘‘Convenient time and place’’,
‘‘Digital radiography systems’’, ‘‘ILO
Classification’’, ‘‘NIOSH’’, ‘‘Panel of B
Readers’’, and ‘‘Radiologic technologist’’
and by adding definitions of ‘‘B Reader’’
and ‘‘Facility’’ to read as follows:
■
§ 37.2
Definitions.
Any term defined in the Federal Mine
Safety and Health Act of 1977 (30 U.S.C.
801 et seq., Pub. L. 95–164, as amended)
and not defined below will have the
meaning given it in the Act. As used in
this subpart:
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Act means the Federal Mine Safety
and Health Act of 1977 (30 U.S.C. 801,
et seq., Pub. L. 95–164, as amended).
B Reader means a physician certified
by NIOSH as able to classify chest
radiographs using the ILO Classification
system, pursuant to § 37.52(b).
*
*
*
*
*
Convenient time and place means that
an examination conducted pursuant to
this part must be given at a reasonable
hour in the locality in which the miner
resides or a location that is equally
accessible to the miner. For example,
examinations at the mine during,
immediately preceding, or immediately
following work and a ‘‘no appointment’’
examination at a medical facility in a
community easily accessible to the
residences of a majority of the miners
working at the mine will be considered
of equivalent convenience for purposes
of this definition.
Digital radiography systems, as used
in this context, include both Digital
Radiography (DR) and Computed
Radiography (CR) systems.
(1) Computed radiography (CR) is the
term for digital radiographic image
acquisition systems that detect
radiographic signals using a cassettebased 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 radiographic image
acquisition systems in which the
radiographic signals received by the
image detector are converted nearly
instantaneously to electronic signals
without movable cassettes.
Facility means a facility or
organization licensed to provide health
care by the State or Territory in which
services are provided, such as a
hospital, a clinic, or other provider that
performs medical examinations.
ILO Classification means the
classification of radiographs using the
International Classification of
Radiographs of Pneumoconioses, a
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
approved by NIOSH as equivalent. The
ILO Classification is incorporated by
reference into §§ 37.50(a) and (c) and
37.51(b).
*
*
*
*
*
NIOSH means the National Institute
for Occupational Safety and Health
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(NIOSH), located within the Centers for
Disease Control and Prevention (CDC).
Within NIOSH, the Respiratory Health
Division (RHD), 1095 Willowdale Road,
Morgantown, WV 26505, is the
organizational unit that has
programmatic responsibility for the Coal
Workers’ Health Surveillance Program.
*
*
*
*
*
Panel of B Readers means the group
of physicians that are currently certified
by NIOSH as B Readers and who
classify or otherwise evaluate
radiographs for the Coal Workers’
Health Surveillance Program.
*
*
*
*
*
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 radiographs as
specified by the State or Territory and
examining facility in which such
services are provided. Optimally, such
an individual will have completed a
formal training program in radiography
leading to a certificate, an associate
degree, or a bachelor’s degree and
participated in the voluntary initial
certification and annual renewal of
registration for radiologic technologists
offered by the American Registry of
Radiologic Technologists.
*
*
*
*
*
■ 3. Revise § 37.3 to read as follows:
§ 37.3 Chest radiographs required for
miners.
(a) Voluntary examinations. Every
operator must provide to each miner
who is employed in or at any of its coal
mines and who was employed in coal
mining prior to December 30, 1969, or
who has completed the required
examinations under paragraph (b) of
this section an opportunity for a chest
radiograph at no cost to the miner in
accordance with this subpart:
(1) NIOSH will notify the operator of
each coal mine of a period within which
the operator may provide examinations
to each miner employed at its coal mine.
The period must begin no sooner than
3.5 years and end no later than 4.5 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 for
each mine, the operator may select a 6month period within which to provide
examinations in accordance with a plan
approved under § 37.101.
(2) Within either the next or future
period(s) specified to the operator for
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each of its coal mines, the operator of
the coal mine may select a different 6month period for each of its mines
within which to offer examinations. In
the event the operator does not submit
an approved plan, NIOSH will specify a
6-month period to the operator within
which miners must have the
opportunity for examinations.
(b) Mandatory examinations. Every
operator must provide to each miner
who begins working in or at an
underground coal mine for the first time
after December 30, 1969 or in or at a
surface coal mine for the first time after
August 1, 2014:
(1) An initial chest radiograph, as
soon as possible, but in no event later
than 30 days after commencement of
employment or within 30 days of
approval of a plan to provide chest
radiographs. An initial chest radiograph
given to a miner according to former
regulations for this subpart prior to
August 1, 2014 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 coal mining. A
second radiograph given to a miner
according to former regulations under
this subpart prior to August 1, 2014 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 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 pneumoconiosis, or
complicated pneumoconiosis (ILO
Classification) or if the second
spirometry examination specified in
§ 37.92(b)(2) shows evidence of
decreased lung function to the extent
specified in § 37.92(b)(3).
(c) Notification. NIOSH will notify the
miner when he or she is due to receive
the second or third mandatory
examination under paragraph (b) of this
section. NIOSH will notify the coal
mine operator when the miner is to be
given a second examination.
(1) The operator will be notified of a
miner’s third examination only with the
miner’s written consent. The notice to
the operator will not state the medical
reason for the examination or that it is
the third examination in the series.
(2) 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 NIOSH-approved
operator’s plan will constitute the
operator’s compliance with the
requirement to provide a third
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mandatory examination even if the
miner refuses to take the examination.
(d) Availability of chest radiographs.
The opportunity for chest radiographs to
be made available by an operator for
purposes of this subpart must be
provided in accordance with a plan that
has been submitted and approved in
accordance with this part.
■ 4. Revise § 37.4 to read as follows:
§ 37.4 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:
(1) Where, in the judgment of the
Secretary, due to the lack of adequate
medical or other necessary facilities or
personnel at the mine or in the locality
where the miner resides, the required
radiographic examination cannot be
given.
(2) Where the operator has not
submitted an approvable plan.
(3) Where, after commencement of an
operator’s program pursuant to an
approved plan and after notice to the
operator of his failure to follow the
approved plan and, after allowing 15
calendar days to bring the program into
compliance, the Secretary determines
and notifies the operator in writing that
the operator’s program still fails to
comply with the approved plan.
(b) The operator of the mine must
reimburse the Secretary or other person,
agency, or institution as the Secretary
may direct, for the cost of conducting
each examination made in accordance
with this section.
(c) All examinations given or arranged
by the Secretary will comply with the
time requirements of § 37.3. Whenever
the Secretary gives or arranges for the
examinations of miners at a time, a
written notice of the arrangements will
be sent to the operator who must post
the notice on the mine bulletin board.
■ 5. Revise § 37.10 to read as follows:
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§ 37.10 Standards incorporated by
reference.
(a) Certain material is incorporated by
reference into this subpart, Subpart—
Chest Radiographic Examinations, with
the approval of the Director of the
Federal Register under 5 U.S.C. 552(a)
and 1 CFR part 51. To enforce any
edition other than that specified in this
section, NIOSH must publish notice of
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18:21 Oct 21, 2016
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change in the Federal Register and the
material must be available to the public.
All approved material is available for
inspection at NIOSH, Respiratory Health
Division, 1095 Willowdale Road,
Morgantown, WV 26505. To arrange for
an inspection at NIOSH, call 304–285–
5749. Copies are also available for
inspection at the National Archives and
Records Administration (NARA). For
information on the availability of this
material at NARA, call 202–741–6030 or
go to https://www.archives.gov/federal_
register/code_of_federal_regulations/
ibr_locations.html.
(b) American Association of
Physicists in Medicine, Order
Department, Medical Physics
Publishing, 4513 Vernon Blvd.,
Madison, WI 53705, https://
www.aapm.org/pubs/reports:
(1) AAPM On-Line Report No. 03,
Assessment of Display Performance for
Medical Imaging Systems, April 2005,
into § 37.51(d) and (e).
(2) AAPM Report No. 14, Performance
Specifications and Acceptance Testing
for X-Ray Generators and Automatic
Exposure Control Devices, Report of the
Diagnostic X-Ray Imaging Committee
Task Group on Performance
Specifications and Acceptance Testing
for X-Ray Generators and Automatic
Exposure Control Devices, published by
the American Institute of Physics for
AAPM, January 1985, into §§ 37.42(h)
and 37.44(g).
(3) AAPM Report No. 31,
Standardized Methods for Measuring
Diagnostic X-Ray Exposures, Report of
Task Group 8, Diagnostic X-Ray Imaging
Committee, published by the American
Institute of Physics, July 1990, into
§ 37.44(g).
(4) AAPM Report No. 74, Quality
Control in Diagnostic Radiology, Report
of Task Group 12, Diagnostic X-Ray
Imaging Committee, published by
Medical Physics Publishing for AAPM,
July 2002, into §§ 37.42(h), 37.43(f), and
37.44(g).
(5) AAPM Report No. 93, Acceptance
Testing and Quality Control of
Photostimulable Storage Phosphor
Imaging Systems, October 2006, into
§§ 37.42(i) and 37.44(g).
(6) AAPM Report No. 116, An
Exposure Indicator for Digital
Radiography, Report of AAPM Task
Group 116, published by AAPM, July
2009, into § 37.44(g).
(c) American College of Radiology,
1891 Preston White Dr., Reston, VA
20191, https://www.acr.org:
(1) ACR Practice Guideline for
Diagnostic Reference Levels in Medical
X-Ray Imaging, Revised 2008
(Resolution 3), into §§ 37.42(i) and
37.44(g).
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73281
(2) [Reserved]
(d) International Labour Office, CH–
1211 Geneva 22, Switzerland, https://
www.ilo.org/publns:
(1) Guidelines for the Use of the ILO
International Classification of
Radiographs of Pneumoconioses,
Revised Edition 2011, into §§ 37.50(a),
37.50(c), and 37.51(b).
(2) [Reserved]
(e) National Council on Radiation
Protection and Measurements, NCRP
Publications, 7910 Woodmont Avenue,
Suite 400, Bethesda, MD 20814–3095,
Telephone (800) 229–2652, https://
www.ncrppublications.org:
(1) NCRP Report No. 102, Medical Xray, Electron Beam, and Gamma-Ray
Protection for Energies Up to 50 MeV
(Equipment Design, Performance, and
Use), issued June 30, 1989, into § 37.45.
(2) NCRP Report No. 105, Radiation
Protection for Medical and Allied
Health Personnel, issued October 30,
1989, into § 37.45.
(3) NCRP Report No. 147, Structural
Shielding Design for Medical X-Ray
Imaging Facilities, revised March 18,
2005, into § 37.45.
(f) National Electrical Manufacturers
Association, 1300 N. 17th Street,
Rosslyn, VA 22209, https://
medical.nema.org:
(1) DICOM Standard PS 3.3–2011,
Digital Imaging and Communications in
Medicine (DICOM) standard, Part 3:
Information Object Definitions,
copyright 2011, into § 37.42(i).
(2) DICOM Standard PS3.4–2011,
Digital Imaging and Communications in
Medicine (DICOM) standard, Part 4:
Service Class Specifications, copyright
2011, into § 37.42(i).
(3) DICOM Standard PS 3.10–2011,
Digital Imaging and Communications in
Medicine (DICOM) standard, Part 10:
Media Storage and File Format for
Media Interchange, copyright 2011, into
§ 37.42(i).
(4) DICOM Standard PS 3.11–2011,
Digital Imaging and Communications in
Medicine (DICOM) standard, Part 11:
Media Storage Application Profiles,
copyright 2011, into § 37.42(i).
(5) DICOM Standard PS 3.12–2011,
Digital Imaging and Communications in
Medicine (DICOM) standard, Part 12:
Media Formats and Physical Media for
Media Interchange, copyright 2011, into
§§ 37.42(i) and 37.44(a).
(6) DICOM Standard PS 3.14–2011,
Digital Imaging and Communications in
Medicine (DICOM) standard, Part 14:
Grayscale Standard Display Function,
copyright 2011, into §§ 37.42(i)(5) and
37.51(d).
(7) DICOM Standard PS 3.16–2011,
Digital Imaging and Communications in
Medicine (DICOM) standard, Part 16:
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Content Mapping Resource, copyright
2011, into § 37.42(i).
■ 6. Revise § 37.20 to read as follows:
§ 37.20
Miner identification document.
As part of the examination, a Miner
Identification Document (CDC/NIOSH
(M)2.9) which includes an occupational
history questionnaire must be
completed for each miner at the facility
where the examination is made (this
document is required for both
radiographic and spirometry
examinations conducted pursuant to
this part).
■ 7. Revise § 37.40 to read as follows:
§ 37.40
General provisions.
(a) The chest radiographic
examination must be given at a
convenient time and place.
(b) The chest radiographic
examination consists of the chest
radiograph, a completed Chest
Radiograph Classification Form (CDC/
NIOSH 2.8), and a completed Miner
Identification Document (CDC/NIOSH
2.9).
(c) A radiographic examination must
be made in a facility approved in
accordance with § 37.43 or § 37.44.
Chest radiographs of miners under this
section must be performed:
(1) By or under the supervision of a
physician who makes chest radiographs
in the normal course of practice and
who has demonstrated ability to make
chest radiographs of a quality to best
ascertain the presence of
pneumoconiosis; or
(2) By a radiologic technologist as
defined in § 37.2.
■ 8. Revise § 37.43 to read as follows:
sradovich on DSK3GMQ082PROD with RULES3
§ 37.43 Approval of radiographic facilities
that use film radiography systems.
(a) Facilities become eligible to
participate in this program by
demonstrating their ability to make high
quality diagnostic chest radiographs by
submitting to NIOSH six or more sample
chest radiographs made and processed
at the applicant facility and which are
of acceptable quality to one or more
individuals selected by NIOSH from the
panel of B Readers. Applicants must
also submit a radiograph of a plastic
step-wedge object 1 or other test object
(available on loan from NIOSH) that was
made and processed at the same time
with the same technique as the
radiographs submitted and processed at
the facility for which approval is sought.
1 The plastic step-wedge object is described in E.
Dale Trout, John P. Kelley, A Phantom for the
Evaluation of Techniques and Equipment Used for
Roentgenography of the Chest, Amer J Roentgenol
1973;117(4):771–776.
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(1) At least one chest radiograph and
one test object radiograph must have
been made with each unit to be used
hereunder.
(2) All radiographs must have been
made within 15 calendar days prior to
submission and must be marked to
identify the facility where each
radiograph was made, the X-ray
machine used, and the date each was
made.
(3) The chest radiographs will be
returned and may be the same
radiographs submitted pursuant to
§ 37.52(a)(2)(i).
(b) Each radiographic facility
submitting chest radiographs for
approval under this section must
complete and include a Radiographic
Facility Certification Document (CDC
2.11) describing each unit to be used to
make chest radiographs under the Act.
The form must include:
(1) The date of the last radiation safety
inspection by an appropriate licensing
agency or, if no such agency exists, by
a qualified expert as defined in NCRP
Report No. 102 (incorporated by
reference, see § 37.10);
(2) The deficiencies found;
(3) A statement that all the
deficiencies have been corrected; and
(4) The date of acquisition of the unit.
To be acceptable, the radiation safety
inspection must have been made within
1 year preceding the date of application.
(c) Radiographs submitted with
applications for approval under this
section will be evaluated by one or more
individuals selected by NIOSH from the
panel of B Readers or by a qualified
medical physicist or consultant.
Applicants will be advised of any
reasons for denial of approval.
(d) NIOSH or its representatives may
make a physical inspection of the
applicant’s facility and any approved
radiographic facility at any reasonable
time to determine if the requirements of
this subpart are being met.
(e) NIOSH may require a facility
periodically to resubmit radiographs of
a test object, sample radiographs, or a
Radiographic Facility Certification
Document for quality control purposes.
(1) 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.
(2) A copy of a notice withdrawing
approval will be sent to each operator
who has listed the facility as its facility
for giving chest radiographs and must be
displayed on the mine bulletin board
adjacent to the operator’s approved
plan. The approved plan will be
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reevaluated by NIOSH in light of this
change.
(f) A formal written quality assurance
program must be established at each
facility addressing radiation exposures,
equipment maintenance, and image
quality, and must conform to the
standards in AAPM Report No. 74,
pages 1–19, 47–53, and 56 (incorporated
by reference, see § 37.10).
(g) In conducting medical
examinations pursuant to this part,
physicians and radiographic facilities
must maintain the results and analysis
of these examinations (including any
hard copies or digital files containing
individual data, classifications, and
images) consistent with applicable
statutes and regulations governing the
handling and protection of individually
identifiable health information,
including, as applicable, the HIPAA
Privacy and Security Rules (45 CFR part
160 and 45 CFR part 164, subparts A, C,
and E).
■ 9. Revise § 37.44 to read as follows:
§ 37.44 Approval of radiographic facilities
that use digital radiography systems.
(a) Facilities seeking approval must
demonstrate the ability to make high
quality digital chest radiographs by
submitting to NIOSH digital
radiographic image files of a test object
(e.g., a plastic step-wedge or chest
phantom which will be provided on
loan from NIOSH) as well as digital
radiographic image files from six or
more sample chest radiographs that are
of acceptable quality to one or more
individuals selected by NIOSH from the
panel of B Readers and a qualified
medical physicist or consultant, both
designated by NIOSH.
(1) Image files must be submitted on
standard portable media (compact or
digital video disc) and formatted to meet
specifications of the Digital Imaging and
Communications in Medicine (DICOM)
standard PS 3.12–2011 (incorporated by
reference, see § 37.10). Applicants will
be advised of any reasons for denial of
approval.
(2) All submitted images must be
made within 60 days prior to the date
of application using the same technique,
equipment, and software as will be used
by the facility under the requested
approval. At least six chest radiographs
and one test object radiograph must
have been made with each digital
radiographic unit to be used by the
facility under the requested approval.
The corresponding radiographic image
files must be submitted on standard
portable media (compact or digital video
disc) and formatted to meet
specifications of the current DICOM
Standard PS 3.12–2011.
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(3) Documentation must include the
following: the identity of the facility
where each radiograph was made; the Xray machine used; and the model,
version, and production date of each
image acquisition software program and
hardware component.
(4) The submitted sample digital chest
image files must include at least two
taken with the detector in the vertical
position and two in the horizontal
position where the imaging system
permits these positions, and at least two
chest images must be from persons
within the highest quartile of chest
diameters (28 cm or greater).
(b) Each radiographic facility
submitting chest radiographic image
files for approval under this section
must complete and include an
Radiographic Facility Certification
Document (CDC 2.11) describing each
system component, and the models and
versions of image acquisition hardware
and software to be used to make digital
chest radiographs under the Act. The
form must include:
(1) A copy of a dated report signed by
a qualified medical physicist,
documenting the evaluation of radiation
safety and performance characteristics
specified in this section for each digital
radiography system;
(2) A copy of the report of the most
recent radiation safety inspection by a
licensing agency, if such agency exists;
(3) A listing of all deficiencies noted
in either of the reports;
(4) A statement that all the listed
deficiencies have been corrected; and
(5) The names and relevant training
and experience of facility personnel
described in paragraphs (c), (e), and (f)
of this section. To be acceptable, the
report by the medical physicist and
radiation safety inspection specified in
this paragraph (b) must have been made
within 1 year prior to the date of
submission of the application.
(c) Facilities must maintain ongoing
licensure and certification under
relevant local, State, and Federal laws
and regulations for all digital equipment
and related processes covered under
this part.
(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 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 Radiographic
Facility Certification Document.
Approvals granted to facilities under
this section may be suspended or
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withdrawn by notice in writing when,
in the opinion of NIOSH, deficiencies in
the quality of radiographs or
information submitted under this
section warrant such action. A copy of
a notice suspending or withdrawing
approval will be sent to each operator
that has listed the facility for its use
under this part and must be displayed
on the mine bulletin board adjacent to
the operator’s approved plan. The
operator’s approved plan may be
reevaluated by NIOSH in response to
such suspension or withdrawal.
(f) A qualified medical physicist who
is familiar with the facility hardware
and software systems for image
acquisition, manipulation, display, and
storage, must be on site or available as
a consultant. The physicist must be
trained in evaluating the performance of
radiographic equipment and facility
quality assurance programs, and must
be licensed/approved by a State or
Territory of the United States or
certified by a competent U.S. national
board.
(g) Facilities must document that
testing performed by a qualified medical
physicist has verified that performance
of each image acquisition system for
which approval is sought met initial
specifications and standards of the
equipment manufacturer and
performance testing as required under
paragraphs (c), (f), and (h) of this
section.
(h) A formal written quality assurance
program must be established at each
facility addressing radiation exposures,
equipment maintenance, and image
quality, and must conform to the
standards in AAPM Report No. 74,
pages 1–19, 47–53, and 56, and AAPM
Report No. 116, sections VIII, IX, and X
(incorporated by reference, see § 37.10).
(1) Applications for facility approval
must include a comprehensive
assessment by a qualified medical
physicist within 12 months prior to
application addressing the performance
of X-ray generators, automatic exposure
controls, and image capture systems.
The assessment must comply with the
following guidelines: AAPM Report No.
93, pages 1–68; AAPM Report No. 74,
pages 6–11; and AAPM Report No. 14,
pages 1–96 (incorporated by reference,
see § 37.10).
(2) Radiographic technique charts
must be used that are developed
specifically for the radiography system
and detector combinations used,
indicating exposure parameters by
anatomic measurements. If automated
exposure control devices are used,
calibration for chest imaging must be
documented using the actual voltages
and image capture systems.
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(i) Radiological exposures resulting
from at least ten (randomly selected)
digital chest images obtained at the
facility must be monitored at least
quarterly to detect and correct potential
dose creep, using methods specified in
AAPM Report No. 31 (incorporated by
reference, see § 37.10). Radiation
exposures must be compared to a
professionally accepted reference level
published in the American College of
Radiology (ACR) Practice Guideline for
Diagnostic Reference Levels in Medical
X-Ray Imaging, pages 1–6 (incorporated
by reference, see § 37.10).
(ii) The medical physicist must
conduct an annual assessment of
measured or estimated radiation
exposures, with specific recommended
actions to minimize exposures during
examinations performed under this part.
(3) For each digital radiography
device and system, performance must be
monitored annually in accordance with
the recommendations of AAPM Report
No. 93 (incorporated by reference, see
§ 37.10), except for the testing
specifically excluded below.
Documentation must be maintained on
the completion of quality assurance
testing, including the reproducibility of
X-ray output, linearity and
reproducibility of mA settings, accuracy
and reproducibility of timer and kVp
settings, accuracy of source-to-detector
distance, and X-ray field focal spot size,
selection, beam quality, congruence and
collimation. For DR systems, the
following tests listed in AAPM Report
No. 93 are not required under this part:
(i) Section 8.4.5: Laser beam function.
(ii) Section 8.4.9: Erasure
Thoroughness.
(iii) Section 8.4.11: Imaging Plate (IP)
Throughput.
(4) Facilities must maintain
documentation, available for inspection
by NIOSH for 5 years, of the ongoing
implementation of policies and
procedures for monitoring and
evaluating the effective management,
safety, and proper performance of chest
image acquisition, digitization,
processing, compression, transmission,
display, archiving, and retrieval
functions of digital radiography devices
and systems.
(i) In conducting medical
examinations pursuant to this part,
physicians and radiographic facilities
must maintain the results and analysis
of these examinations (including any
hard copies or digital files containing
individual data, interpretations, and
images) consistent with applicable
statutes and regulations governing the
handling and protection of individually
identifiable health information,
including, as applicable, the HIPAA
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Privacy and Security Rules (45 CFR part
160 and 45 CFR part 164, subparts A, C,
and E).
■ 10. Revise § 37.50 to read as follows:
§ 37.50 Interpreting and classifying chest
radiographs—film radiography systems.
sradovich on DSK3GMQ082PROD with RULES3
(a) Chest radiographs must be
interpreted and classified in accordance
with the Guidelines for the Use of the
ILO International Classification of
Radiographs of Pneumoconioses
(incorporated by reference, see § 37.10).
Chest radiograph interpretations and
classifications must be recorded on a
paper or electronic Chest Radiograph
Classification Form (CDC/NIOSH 2.8).
(b) Radiographs must be interpreted
and classified only by a physician who
reads chest radiographs in the normal
course of practice and who has
demonstrated proficiency in classifying
the pneumoconioses in accordance with
§ 37.52.
(1) Initial clinical interpretations and
notification of findings other than
pneumoconiosis under paragraph (a) of
this section must be provided by a
qualified physician who provides these
services for the examining facility. This
physician must have all required
licensure and privileges, and must
interpret chest radiographs in the
normal course of practice.
(2) [Reserved]
(c) All interpreters, whenever
interpreting chest radiographs made
under the Act, must have immediately
available for reference a complete set of
the standard radiographs for use with
the Guidelines for the Use of the ILO
International Classification of
Radiographs of Pneumoconioses
(incorporated by reference, see § 37.10).
(d) View boxes used for making
interpretations must comply with the
following:
(1) Fluorescent lamps must be
simultaneously replaced with new
lamps at 6-month intervals;
(2) All the fluorescent lamps in a
panel of boxes must have identical
manufacturer’s ratings as to intensity
and color;
(3) The glass, internal reflective
surfaces, and the lamps must be kept
clean;
(4) The unit must be so situated as to
minimize front surface glare.
■ 11. Revise § 37.51 to read as follows:
§ 37.51 Interpreting and classifying chest
radiographs—digital radiography systems.
(a) For each chest radiograph obtained
at an approved facility using a digital
radiography system, a qualified and
licensed physician who reads chest
radiographs in the normal course of
practice must provide an initial clinical
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interpretation and notification, as
specified in § 37.54, of any significant
abnormal findings other than
pneumoconiosis.
(b) Chest radiographs must be
classified for pneumoconiosis by
physician readers (B Readers) who have
demonstrated ongoing proficiency, as
specified in § 37.52(b), in classifying the
pneumoconioses in a manner consistent
with the Guidelines for the Use of the
ILO International Classification of
Radiographs of Pneumoconioses
(incorporated by reference, see § 37.10).
Chest radiograph classifications must be
recorded on a paper or electronic Chest
Radiograph Classification Form (CDC/
NIOSH 2.8).
(c) All B Readers, whenever
classifying digitally-acquired chest
radiographs made under the Act, must
have immediately available for reference
a complete set of NIOSH-approved
standard digital chest radiographic
images, including electronic images
such as scanned images, provided for
use with the Guidelines for the Use of
the ILO International Classification of
Radiographs of Pneumoconioses
(incorporated by reference, see § 37.10).
(1) Only NIOSH-approved standard
digital (electronic) images may be used
for classifying digital chest images for
pneumoconiosis.
(2) Modification of the appearance of
the standard images using software tools
is not permitted.
(d) Viewing systems should enable
readers to display the coal miner’s chest
image at the full resolution of the image
acquisition system, side-by-side with
the selected NIOSH-approved standard
images for comparison.
(1)(i) Image display devices must be
flat panel monitors displaying at least 3
MP at 10 bit depth. Image displays and
associated graphics cards must meet the
calibration and other specifications of
the Digital Imaging and
Communications in Medicine (DICOM)
standard PS 3.14–2011 (incorporated by
reference, see § 37.10).
(ii) Image displays and associated
graphics cards must not deviate by more
than 10 percent from the grayscale
standard display function (GSDF) when
assessed according to the AAPM OnLine Report No. 03, pages 1–146
(incorporated by reference, see § 37.10).
(2) Display system luminance
(maximum and ratio), relative noise,
linearity, modulation transfer function
(MTF), frequency, and glare should
meet or exceed recommendations listed
in AAPM On-Line Report No. 03, pages
1–146 (incorporated by reference, see
§ 37.10). Viewing displays must have a
maximum luminance of at least 171 cd/
m2, a ratio of maximum luminance to
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minimum luminance of at least 250, and
a glare ratio greater than 400. The
contribution of ambient light reflected
from the display surface, after light
sources have been minimized, must be
included in luminance measurements.
(3) Displays must be situated so as to
minimize front surface glare. Readers
must minimize reflected light from
ambient sources during the performance
of classifications.
(4) Measurements of the width and
length of pleural shadows and the
diameter of opacities must be taken
using calibrated software measuring
tools. If permitted by the viewing
software, a record must be made of the
presentation state(s), including any
noise reduction and edge enhancement
or restoration functions that were used
in performing the classification,
including any annotations and
measurements.
(e) Quality control procedures for
devices used to display chest images for
classification must comply with the
recommendations of the American
Association of Physicists in Medicine
AAPM On-Line Report No. 03, pages 1–
146 (incorporated by reference, see
§ 37.10).
(1) If automatic quality assurance
systems are used, visual inspection
must be performed using one or more
test patterns recommended by the
medical physicist every 6 months, or
more frequently, to check for defects
that automatic systems may not detect.
(2) [Reserved]
(f) Classification of CR and DR
digitally-acquired chest radiographs
under this part must be performed based
on the viewing of images displayed as
soft copies using the viewing
workstations specified in this section.
Classification of radiographs must not
be based on the viewing of hard copy
printed transparencies of images that
were digitally-acquired.
(g) The classification of chest
radiographs based on digitized copies of
chest radiographs that were originally
acquired using film-screen techniques is
not permissible under this part.
■ 12. Revise § 37.52 to read as follows:
§ 37.52 Proficiency in the use of systems
for classifying the pneumoconioses.
(a) First or A Readers:
(1) Approval of a physician as an A
Reader continues indefinitely if
established prior to October 15, 2012.
(2) Physicians who desire to become
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
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properly classified by one or more
individuals selected by NIOSH from the
panel of B Readers. The six radiographs
must consist of two without
pneumoconiosis, two with simple
pneumoconiosis, and two with
complicated pneumoconiosis (these
may be the same radiographs submitted
for facility approval pursuant to
§§ 37.43 and 37.44). The films will be
returned to the physician. The
classifications must be on the Chest
Radiograph Classification Form (CDC/
NIOSH 2.8); or
(ii) Satisfactory completion, since
June 11, 1970, of a course approved by
NIOSH on the ILO International
Classification of Radiographs of
Pneumoconioses.
(b) Final or B Readers:
(1) Approval as a B Reader established
prior to October 1, 1976, is hereby
terminated.
(2) Proficiency in evaluating chest
radiographs for radiographic quality and
in the use of the ILO Classification for
interpreting chest radiographs for
pneumoconiosis and other diseases
must be demonstrated by those
physicians who desire to be B Readers
by taking and passing a speciallydesigned proficiency examination given
on behalf of or by NIOSH at a time and
place specified by NIOSH.
(i) 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.
(ii) Physicians who qualify under this
provision need not be qualified under
paragraph (a) of this section.
(c) Physicians who wish to participate
in the program must familiarize
themselves with the necessary
components for attainment of reliable
classification of chest radiographs for
the pneumoconioses2 and apply using a
Physician Application for Certification
Form (CDC 2.12(E)).
■ 13. Revise § 37.53 to read as follows:
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§ 37.53 Method of obtaining definitive
chest radiograph classifications.
(a) All chest radiographs which are
first classified by an A or B Reader will
be submitted by NIOSH to a B Reader
qualified pursuant to § 37.52.
(1) If there is agreement between the
two classifications, as described in
paragraph (b) of this section, the result
will be considered final and reported to
MSHA for transmittal to the miner.
2 NIOSH Safety and Health Topic, Chest
Radiography: Radiographic Classification, https://
www.cdc.gov/niosh/topics/chestradiography/
radiographic-classification.html.
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(2) When agreement is lacking,
NIOSH must obtain a third classification
from the panel of B Readers.
(i) If any two of the three
classifications demonstrate agreement,
the result must be considered the final
determination.
(ii) If agreement is lacking among the
three classifications, 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 classifications are considered
to be in agreement when:
(1) They are derived from complete
classifications recorded using approved
paper or electronic versions of the Chest
Radiograph Classification Form (CDC/
NIOSH 2.8) and received by NIOSH; and
(2) Both find either stage A, B, or C
complicated pneumoconiosis; or,
(3) For simple pneumoconiosis, are
both in the same major category or are
within one minor category (ILO
Classification 12-point scale) of each
other (subject to the exception in
paragraph (b)(3)(ii) of this section).
(i) The higher of the two
classifications must be reported.
(ii) The only exception to the one
minor category principle is a reading
sequence of 0/1, 1/0 or 1/0, 0/1, which
are not considered agreement.
■ 14. Revise § 37.54 to read as follows:
§ 37.54 Notification of abnormal
radiographic findings.
(a) Significant abnormal findings
other than pneumoconiosis. The first
physician to interpret the radiograph
must communicate findings of, or
findings suggesting, abnormality of
cardiac shape or size, tuberculosis, lung
cancer, or any other significant
abnormal findings other than
pneumoconiosis to the miner indicated
on the Miner Identification Document or
to the miner’s designated physician. A
notice of the communication must be
submitted to NIOSH. When significant
abnormal findings are reported, NIOSH
will also notify the miner to contact his
or her physician.
(b) Significant changes or progression
of disease. When NIOSH has more than
one radiograph of a miner in its files
and the most recent examination was
found by the first physician to interpret
the radiograph or subsequently by
NIOSH B Readers to show an
abnormality of cardiac shape or size,
tuberculosis, cancer, complicated
pneumoconiosis, and any other
significant abnormal findings, NIOSH
will arrange for a licensed physician to
compare the most recent image to older
images and NIOSH will inform the
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miner of any significant changes or
progression of disease or other findings.
(c) Notice of eligibility for part 90
transfer option. All final determinations
of radiographic classifications providing
evidence for development of
pneumoconiosis will be reported to the
miner or to the miner’s designated
physician by NIOSH. In addition,
NIOSH will coordinate with MSHA to
assure that such miners are notified of
eligibility to transfer to a less dusty area,
in accordance with section 203 of the
Act (see 30 CFR part 90 and § 37.102).
(d) Prompt dispatch of findings.
NIOSH will make every reasonable
effort to process the findings described
in paragraph (c) of this section within
60 days of receipt of the information
described in § 37.60 in a complete and
acceptable form.
(1) NIOSH will coordinate with
MSHA to provide notice of eligibility for
the part 90 transfer option within the
same time frame.
(2) The results of an examination may
not be processed by NIOSH if the
examination was made within 6 months
of the date of a previous acceptable
examination.
■ 15. Revise § 37.60 to read as follows:
§ 37.60 Submitting required chest
radiograph classification and miner
identification documents.
(a) Each chest radiograph required to
be made under this subpart, together
with the completed Chest Radiograph
Classification Form and the completed
Miner Identification Document, must be
submitted together for each miner to
NIOSH within 14 calendar days after the
radiographic examination is given. All
submitted items 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 Chest
Radiograph Classification Form and the
completed Miner Identification
Document, must be submitted to NIOSH
using the software and format specified
by NIOSH either using portable
electronic media, or a secure electronic
file transfer.
(2) 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.
(b) If NIOSH deems any submission
under paragraph (a) of this section
inadequate, the operator will be notified
of the deficiency. The operator must
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promptly make appropriate
arrangements for the necessary
reexamination at no expense to the
miner.
(c) Failure to comply with paragraph
(a) or (b) of this section will be cause to
revoke approval of a plan or any other
approval as may be appropriate. An
approval that has been revoked may be
reinstated at the discretion of NIOSH
after it receives satisfactory assurances
and evidence that all deficiencies have
been corrected and that effective
controls have been instituted to prevent
a recurrence.
(d) Chest radiographs and other
required documents must be submitted
only for miners.
(e) If a miner refuses to participate in
all phases of the examination prescribed
in this subpart, no report need be made.
If a miner refuses to participate in any
phase of the examination prescribed in
this subpart, all forms must be
submitted with his or her name and the
last four digits of the Social Security
number on each. If any form cannot be
completed because of the miner’s
refusal, it must be marked ‘‘Miner
Refuses,’’ and submitted to NIOSH. No
submission will be made, however,
without a completed Miner
Identification Document (CDC/NIOSH
2.9) containing the miner’s name,
address, last four digits of the Social
Security number and place of
employment.
■ 16. Revise § 37.70 to read as follows:
sradovich on DSK3GMQ082PROD with RULES3
§ 37.70
Review of classifications.
(a) Any miner who believes the
classification 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.
(1) If the classification was based on
agreement between an A Reader and a
B Reader, NIOSH will obtain one or
more additional classifications by B
Readers as necessary to obtain
agreement in accordance with § 37.53,
and MSHA must report the results to the
miner together with notification from
MSHA of any rights which may accrue
to the miner in accordance with
§ 37.102.
(2) If the reported classification was
based on agreement between two (or
more) B Readers, the reading will be
accepted as conclusive and the miner
must be so informed by MSHA.
(b) Any operator who is directed by
MSHA to transfer a miner to a less dusty
atmosphere based on the most recent
examination 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
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miner will be notified by MSHA
whether the miner is entitled to the
option to transfer.
■ 17. Revise § 37.80 to read as follows:
§ 37.80 Availability of records for
radiographs.
(a) Medical information and
radiographs on miners will be released
by NIOSH only with the written consent
from the miner, or if the miner is
deceased, written consent from the
miner’s widow or widower, next of kin,
or legal representative.
(b) To the extent authorized, original
film radiographs will be made available
for examination only at the NIOSH
facility in Morgantown, WV.
■ 18. Revise the subpart heading above
§ 37.90 to read as follows:
Subpart—Spirometry Testing
■
19. Revise § 37.90 to read as follows:
§ 37.90
Scope.
Under this subpart, coal mine
operators are required to provide
spirometry testing to both current and
newly employed coal miners, using
medical facilities approved by NIOSH in
accordance with standards established
in this subpart.
■ 20. Revise § 37.91 to read as follows:
§ 37.91
Definitions.
Definitions provided in § 37.2 will
have the same meaning in this subpart.
Any term defined in the Federal Mine
Safety and Health Act of 1977 (Pub. L.
95–164, as amended) and not defined in
§ 37.2 or this section will have the
meaning given it in the Act. As used in
this subpart:
ATS means American Thoracic
Society.
ERS means European Respiratory
Society.
FET means forced expiratory time,
which is the time from the beginning of
a forced exhalation (the backextrapolated ‘‘time zero’’) maneuver to
the end of expiration.
FEV1 means forced expiratory volume
in one second, which is the greatest
volume of air that can be forcibly blown
out within the first second, after full
inspiration.
FEV1/FVC means the ratio between
the largest acceptable FEV1 and the
largest acceptable FVC following the
forced vital capacity maneuver. It is
usually reported as a percentage.
FEV6 means forced expiratory volume
in six seconds, which is the greatest
volume of air that can forcibly be blown
out in six seconds, after full inspiration.
FVC means forced vital capacity,
which is the greatest volume of air that
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can forcibly be blown out after full
inspiration.
PEF means peak expiratory flow,
which is the maximal airflow generated
during a forced vital capacity maneuver.
Spirometry test means a pulmonary
function test that measures expiratory
volume and airflow rates and may
determine the presence and severity of
lung function impairments, if such are
present.
■ 21. Revise § 37.92 to read as follows:
§ 37.92 Spirometry testing required for
miners.
(a) Voluntary tests. Each operator
must provide to all miners who are
employed in or at any of its coal mines
the opportunity to have a spirometry
test and a respiratory assessment at no
cost to the miner at least once every 5
years in accordance with this subpart.
The tests will be available during a 6month period that begins no less than
3.5 years and not more than 4.5 years
from the end of the last 6-month period.
(b) Mandatory tests. Every operator
must provide to each miner who begins
work in or at a coal mine for the first
time on or after August 1, 2014,
spirometry testing and respiratory
assessment at no cost to the miner in
accordance with this subpart.
(1) Initial spirometry testing and
respiratory assessment will be provided
to all miners who begin work in or at
a coal mine for the first time on or after
August 1, 2014 within the first 30 days
of their employment or within 30 days
of approval of a plan to provide
spirometry testing.
(2) A follow-up second spirometry
test and respiratory assessment will be
provided to the miner no later than 3
years after the initial spirometry if the
miner is still engaged in coal mining.
(3) A third spirometry test and
respiratory assessment will be provided
no later than 2 years after the tests in
paragraphs § 37.3(b)(2) and paragraph
(b)(2) of this section if the chest
radiograph shows evidence of
pneumoconiosis as defined in
§ 37.3(b)(3) or if the second spirometry
test results demonstrate a 15 percent or
greater decline in the percent predicted
FEV1 value since the initial (i.e.,
baseline) test.
(i) Percent predicted FEV1 will be
calculated according to prediction
equations published in Spirometric
Reference Values from a Sample of the
General U.S. Population, American
Journal of Respiratory and Critical Care
Medicine, 159(1):179–187, January 1999
(incorporated by reference, see § 37.98).
(ii) A correction factor to Caucasian
reference values will be applied when
testing individuals of Asian descent as
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specified in the ATS Technical
Standards: Spirometry in the
Occupational Setting, p. 987
(incorporated by reference, see § 37.98).
(c) Notification. NIOSH will notify the
miner when he or she is due to receive
the second or third mandatory test
under paragraph (b) of this section.
NIOSH will notify the coal mine
operator when the miner is to perform
a second spirometry test.
(1) The operator will be notified of a
miner’s eligibility for a third test only
with the miner’s written consent. The
notice to the operator will not state the
medical reason for the test or that it is
the third test in the series.
(2) If the miner is notified by NIOSH
that the third mandatory test is due and
the operator is not so notified,
availability of spirometry testing under
the NIOSH-approved operator’s plan
will constitute the operator’s
compliance with the requirement to
provide a third spirometry test even if
the miner does not take the test.
(d) Availability of spirometry testing.
The opportunity for spirometry to be
available for purposes of this subpart
must be indicated in an operator’s plan
that has been submitted and approved
in accordance with this subpart.
■ 22. Revise § 37.93 to read as follows:
sradovich on DSK3GMQ082PROD with RULES3
§ 37.93
Approval of spirometry facilities.
(a) Application for facility approval.
Facilities seeking approval to provide
the spirometry testing specified under
this subpart must have the ability to
provide spirometry of high technical
quality. Thus, NIOSH-approved
facilities must meet the requirements
specified in this subpart for the
following activities: Training of
technicians who perform the tests;
conducting spirometry tests using
equipment and procedures that meet
required specifications; collecting the
respiratory assessment form;
transmitting data to NIOSH; and
communicating with miners as required
for scheduling, testing, and notification
of results. Facilities seeking approval
may apply to NIOSH using the
Spirometry Facility Certification
document (CDC/NIOSH 2.14).
(b) Spirometry quality assurance. A
spirometry quality assurance program
must be in place to minimize the rate of
invalid test results. This program must
include all of the following components:
(1) Instrument calibration checks.
Testing personnel must fully comply
with the 2005 ATS/ERS Standardisation
of Spirometry guidelines for instrument
calibration check procedures, pp. 322–
323, including Table 3 (incorporated by
reference, see § 37.98).
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(i) For volume spirometers,
calibration check procedures must
include daily (day of testing) leak and
volume accuracy checks. In addition,
volume linearity checks must be
performed according to the frequency
established by the 2005 ATS/ERS
guidelines.
(ii) For flow-type spirometers,
calibration must be checked daily by
injecting 3 liters of air from a calibration
syringe at 3 different speeds (fast,
medium, slow). Flow linearity must be
checked weekly as established by the
2005 ATS/ERS guidelines.
(iii) Instrument calibration check
records must be maintained by the
facility and available for inspection by
NIOSH, as deemed necessary.
(2) Automated maneuver and test
session quality checks. The spirometer
software must automatically perform
quality assurance checks on expiratory
maneuvers during each spirometry
testing session. Screen displayed error
messages must alert the technician to
maneuver acceptability and test session
non-repeatability. Each spirometry test
session must have the goal of obtaining
3 acceptable with 2 repeatable forced
vital capacity maneuvers, as defined by
the 2005 ATS/ERS Standardisation of
Spirometry, p. 325 (incorporated by
reference, see § 37.98).
(3) Ongoing monitoring of test quality.
Facilities must submit spirometry
results to NIOSH within 14 calendar
days of testing as specified in § 37.96(c)
to permit NIOSH to monitor test quality
and provide a results report to each
miner. NIOSH may provide quality
performance feedback to the appropriate
technician(s) along with suggestions for
improvement.
(4) Quality assurance audits. NIOSH
may periodically conduct audits to
review tests submitted by approved
facilities and assess the quality of
spirometry provided. Such audits may
include a review of all spirometry data
obtained during a specified time period
or review of spirometry test data
collected over time on selected miners.
(c) Noncompliance. If NIOSH
determines that a facility is not
compliant with the policies and
procedures specified in this subpart, or
determines as the result of a quality
assurance audit as specified in this
section that a facility is not performing
spirometry of adequate quality, the
facility will be notified of the
deficiency. The facility must promptly
make appropriate arrangements for the
deficiency to be rectified.
(d) Revocation of approval. If a
facility fails to rectify deficiencies
within 60 days of notification, NIOSH
approval of the facility may be revoked.
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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 by the facility to prevent a
recurrence.
(e) Maintenance of records. When
conducting spirometry tests pursuant to
this subpart, physicians and facilities
must maintain the results and analyses
of these tests (including any hard copies
or digital files containing individual
data, such as interpretations) in a
manner consistent with applicable
statutes and regulations governing the
handling and protection of individually
identifiable health information,
including, as applicable, the HIPAA
Privacy and Security Rules (45 CFR part
160 and 45 CFR part 164, subparts A, C,
and E).
■ 23. Revise § 37.94 to read as follows:
§ 37.94
Respiratory assessment form.
As part of the spirometry testing and
concurrent with it, personnel at the
facility must complete a Respiratory
Assessment Form (CDC/NIOSH 2.13).
■ 24. Revise § 37.95 to read as follows:
§ 37.95 Specifications for performing
spirometry tests.
(a) Persons administering spirometry
tests. Each person administering
spirometry tests for the Coal Workers’
Health Surveillance Program must
successfully complete a NIOSHapproved spirometry training course
and maintain a valid certificate by
periodically completing NIOSHapproved spirometry refresher training
courses, identified on the NIOSH Web
site at https://www.cdc.gov/niosh/. A
copy of the certificate of completion
from a NIOSH-approved spirometry
training or refresher course, with
validation dates printed on the
document, must be available for
inspection. NIOSH will assign each
person administering spirometry tests a
unique identification number, which
must be entered into the spirometry
system computer whenever instrument
quality assurance or miner testing is
done or on the Spirometry Results
Notification Form (CDC/NIOSH 2.15).
(b) Spirometer specifications.
Spirometry testing equipment must
meet the 2005 ATS/ERS Standardisation
of Spirometry specifications for
spirometer accuracy and precision and
real-time display size and content, pp.
331–333, including Table 2 on p. 322
and Table 6 on p. 332 (incorporated by
reference, see § 37.98). Facilities must
make available for inspection written
verification from a third-party testing
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laboratory (not the manufacturer or
distributor) that the model of spirometer
being used has successfully passed its
validation checks as required by the
Standardization of Spirometry; 1994
Update protocol, Appendix B pp. 1126–
1134, including Table C1 (incorporated
by reference, see § 37.98). Facilities may
request such documentation from
spirometer manufacturers. For each
forced expiratory maneuver submitted
for a miner under this part, the
spirometry data file must retain a record
of the parameters defined in the 2005
ATS/ERS Standardisation of
Spirometry, p. 335 including Table 8
(incorporated by reference, see § 37.98).
Spirometers that provide electronic
transfer of spirometry data results files
must use the format, content, and data
structure specified by the 2005 ATS/
ERS Standardisation of Spirometry, p.
335, or a procedure for data transfer that
is approved by NIOSH.
(c) Spirometry procedures.
Administration of spirometry must
include the following:
(1) Miner Identification Document.
The Miner Identification Document
(CDC/NIOSH (M)2.9), described in
§ 37.20, must be completed for each
miner at the facility where spirometry is
performed.
(2) Pre-test checklist. The Spirometry
Pre-Test Checklist portion of the
Spirometry Results Notification Form
(CDC/NIOSH 2.15) must be completed
prior to each spirometry session to
identify possible contraindications to
testing, or factors that might affect
results.
(3) Respiratory Assessment Form. A
standardized Respiratory Assessment
Form (CDC/NIOSH 2.13) must be
completed at the initial spirometry and
repeated at each spirometry testing
procedure.
(4) Collection of anthropometric and
demographic information. The miner’s
standing height must be measured in
stocking feet using a stadiometer (or
equivalent device) each time the miner
performs spirometry. The miner’s
weight must also be measured (in
stocking feet). The miner’s birth date,
race, and ethnicity must also be
recorded. These data will be entered
into the spirometry system computer
and transmitted with the spirometry
data file or, if required under the
facility’s approval, on the Spirometry
Results Notification Form (CDC/NIOSH
2.15).
(5) Test procedures. Spirometry will
be conducted in accordance with test
procedures defined in the 2005 ATS/
ERS Standardisation of Spirometry, pp.
323–326, and the Standardisation of
Lung Function Testing, Replies to
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Readers, pp. 1496–1498 (both
incorporated by reference, see § 37.98).
(i) The technician must be able to
view real-time testing display screens as
specified in the 2005 ATS/ERS
Standardisation of Spirometry, p. 322
(incorporated by reference, see § 37.98).
(ii) A miner will be tested in the
standing position, but may be seated if
he or she experiences lightheadedness
or other signs or symptoms that raise a
safety concern relating to the standing
position during the spirometry test.
(d) Records retention. On-site records
of the results will include spirometry
test reports and retention of all
spirometry sessions, pre-test checklists,
and standardized respiratory assessment
results in electronic or printed format
until notification to delete or render the
information inaccessible, as described
in § 37.100(b)(6)(ii), is received from
NIOSH.
■ 25. Revise § 37.96 to read as follows:
§ 37.96 Spirometry interpretations,
reports, and submission.
(a) Interpretation of spirometry tests.
Interpretations will be carried out by
physicians or other qualified health care
professionals with expertise in
spirometry who have all required
licensure and privileges to provide this
service in their State or Territory.
Interpretations must be carried out
using procedures and criteria consistent
with recommendations in the ATS
Technical Standards: Spirometry in the
Occupational Setting, pp. 987–990, and
the ATS/ERS Interpretative Strategies
for Lung Function Tests, p. 950, p. 956
including Table 5, and p. 957 including
Table 6 (both incorporated by reference,
see § 37.98).
(b) Spirometry reports at NIOSHapproved spirometry facilities. (1)
Spirometry test reports must contain the
following:
(i) The miner’s age, height, gender,
race, and weight;
(ii) Numerical values (FVC, FEV6,
FEV1, FEV1/FVC, FEV1/FEV6, FET, and
PEF) and volume-time and flow-volume
spirograms for all recorded expiratory
maneuvers; normal reference value set
used; and the predicted, percent
predicted, and lower limit of normal
threshold values;
(iii) Miner position during testing
(standing or sitting);
(iv) Dates of test and last calibration
check;
(v) Ambient temperature and
barometric pressure (volume
spirometers); and
(vi) The technician’s unique
identification number.
(2) NIOSH will notify the submitting
facility when to permanently delete or,
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if this is not technologically feasible for
the spirometry system used, render
permanently inaccessible all files and
forms associated with a miner’s
spirometry test from its electronic and
physical files.
(c) Submission of spirometry results.
Facilities must submit results of
spirometry tests electronically with
content as specified in § 37.96(b),
completed pre-test screening checklists
(found in Spirometry Results
Notification Form CDC/NIOSH 2.15),
and completed Respiratory Assessment
Form (CDC/NIOSH 2.13) within 14
calendar days of testing a miner.
(1) Electronic spirometry test results.
Submission of spirometry test results in
the form of an electronic data file in a
format approved by NIOSH is preferred.
Facilities must utilize a secure internet
data transfer site specified by NIOSH.
Data submission must be performed as
specified in the facility’s approval. The
transmitted spirometry data files must
include a variable length record
providing all parameters in the format,
content, and data structure described by
the 2005 ATS/ERS Standardisation of
Spirometry, p. 335 including Table 8
(incorporated by reference, see § 37.98),
or an alternate data file that is approved
by NIOSH.
(2) Spirometry test results submitted
using the Spirometry Results
Notification form. If specified under a
facility’s approval, spirometry results
may be provided using the Spirometry
Results Notification Form (CDC/NIOSH
2.15). The form must be completed and
submitted electronically, accompanied
by image files in a format approved by
NIOSH that documents the flow-volume
and volume-time curves for each trial
reported on the form. The method of
electronic submission must be approved
by NIOSH and carried out securely as
specified for electronic data files in
§ 37.96(c)(1).
(d) Confidentiality of spirometry
results. Individual medical information
and spirometry results are considered
protected health information under
HIPAA and may only be released as
specified by HIPAA or to NIOSH, as
discussed in paragraph (d)(1) of this
section, and maintained by the
spirometry facility as specified in
§ 37.93(e).
(1) Personally identifiable information
in the possession of NIOSH will be
released only with the written consent
of the miner or, if the miner is deceased,
the written consent of the miner’s next
of kin or legal representative.
(2) To provide on-site back-up and
assure complete data transfer, facilities
must retain the forms and results (in
electronic or paper format) from a
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miner’s test until instruction has been
received from NIOSH to delete the
associated files and forms or, if this is
not technologically feasible, render the
data permanently inaccessible.
■ 26. Revise § 37.97 to read as follows:
§ 37.97
Notification of spirometry results.
(a) Findings must be communicated to
the miner or, if requested by the miner,
to the miner’s designated physician. The
health care professional at the NIOSHapproved facility must inform the miner
if the spirometry shows abnormal
results or if the respiratory assessment
suggests he or she may benefit from the
medical follow-up or a smoking
cessation intervention.
(b) NIOSH will notify the miner of his
or her spirometry test results, a
comparison between current and
previously submitted spirometry tests (if
available), and will advise the miner to
contact a health care professional as
appropriate based on the results.
■ 27. Add § 37.98 to read as follows:
sradovich on DSK3GMQ082PROD with RULES3
§ 37.98 Standards incorporated by
reference.
(a) Certain material is incorporated by
reference into this subpart, Subpart—
Spirometry Testing, with the approval
of the Director of the Federal Register
under 5 U.S.C. 552(a) and 1 CFR part 51.
To enforce any edition other than that
specified in this section, NIOSH must
publish notice of change in the Federal
Register and the material must be
available to the public. All approved
material is available for inspection at
NIOSH, Respiratory Health Division,
1095 Willowdale Road, Morgantown,
WV 26505. To arrange for an inspection
at NIOSH, call 304–285–5749. Copies
are also available for inspection at the
National Archives and Records
Administration (NARA). For
information on the availability of this
material at NARA, call 202–741–6030 or
go to https://www.archives.gov/federal_
register/code_of_federal_regulations/
ibv_locations.html.
(b) American Journal of Respiratory
and Critical Care Medicine, American
Thoracic Society (ATS), 25 Broadway,
18th Floor, New York, NY 10004.
Phone: (800) 635–7181, extension 8065.
Email: Hope.Robinson@sheridan.com.
https://www.atsjournals.org/action/
showHome:
(1) Standardization of Spirometry;
1994 Update. Official Statement of the
ATS, adopted November 11, 1994.
American Journal of Respiratory and
Critical Care Medicine 152(3):1107–
1136, September 1995, into § 37.95(b).
This ATS Official Statement is also
available at https://www.atsjournals.org/
doi/pdf/10.1164/ajrccm.152.3.7663792.
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(2) Official American Thoracic
Society Technical Standards:
Spirometry in the Occupational Setting
(‘‘ATS Technical Standards: Spirometry
in the Occupational Setting’’). Redlich
CA, Tarlo SM, Hankinson JL, Townsend
MC, Eschenbacher WL, Von Essen SG,
Sigsgaard T, and Weissman DN.
American Journal of Respiratory and
Critical Care Medicine 189(8):983–994,
April 15, 2014, into §§ 37.92(b) and
37.96(a).
(3) Spirometric Reference Values from
a Sample of the General U.S.
Population. Hankinson JL, Odencrantz
JR, Fedan KB. American Journal of
Respiratory and Critical Care Medicine,
159(1):179–187, January 1999, into
§ 37.92(b).
(c) European Respiratory Journal, 442
Glossop Road, Sheffield, S10 2PX, UK.
Phone: 44 114 267 28 60; Fax: 44 114
266 50 64. Email: info@ersj.org.uk.
https://erj.ersjournals.com/.
(1) Standardisation of Spirometry
(‘‘2005 ATS/ERS Standardisation of
Spirometry’’). ATS/ERS Task Force:
Standardization of Lung Function
Testing. Miller MR, Hankinson J,
Brusasco V, Burgos F, Casaburi R,
Coates A, Crapo R, Enright P, van der
Grinten CPM, Gustafsson P, Jensen R,
Johnson DC, MacIntyre N, McKay R,
Navajas D, Pedersen OF, Pellegrino R,
Viegi G, and Wanger J. European
Respiratory Journal 26(2):319–338,
August 2005, into §§ 37.93(b); 37.95(b)
and (c); and 37.96(c). The ATS/ERS
Standardisation of Spirometry is also
available on the ATS Web site at https://
www.thoracic.org/statements/resources/
pfet/PFT2.pdf.
(2) Interpretative Strategies for Lung
Function Tests (‘‘ATS/ERS
Interpretative Strategies for Lung
Function Tests’’). ATS/ERS Task Force:
Standardisation of Lung Function
Testing. Pellegrino R, Viegi G, Brusasco
V, Crapo RO, Burgos F, Casaburi R,
Coates A, van der Grinten CPM,
Gustafsson P, Hankinson J, Jensen R,
Johnson DC, MacIntyre N, McKay R,
Miller MR, Navajas D, Pedersen OF, and
Wanger J. European Respiratory Journal
26(5):948–968, November 2005, into
§ 37.96(a). The ATS/ERS
Standardisation of Lung Function
Testing is also available on the ATS
Web site at https://www.thoracic.org/
statements/resources/pft/pft5.pdf.
(3) Standardisation of Lung Function
Testing, the Authors’ Replies to Readers’
Comments (‘‘Standardisation of Lung
Function Testing, Replies to Readers’’).
Miller MR, Hankinson J, Brusasco V,
Burgos F, Casaburi R, Coates A, Enright
P, van der Grinten C, Gustafsson P,
Jensen R, MacIntyre N, McKay RT,
Pedersen OF, Pellegrino R, Viegi G, and
PO 00000
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Fmt 4701
Sfmt 4700
73289
Wanger J. European Respiratory Journal
36(6):1496–1498, December 2010, into
§ 37.95(c). The Standardisation of Lung
Function Testing, Replies to Readers is
also available on the ATS Web site at
https://www.thoracic.org/statements/
resources/pft/clarification-12-2010.pdf.
■ 28. Revise § 37.100 to read as follows:
§ 37.100 Coal mine operator plan for
medical examinations.
(a) Each coal mine operator must
submit and receive NIOSH approval of
a plan for the provision of chest
radiographs, occupational histories,
spirometry tests, and respiratory
assessments of miners, using the
appropriate forms provided by NIOSH.
(1) During the transition from August
1, 2014 until the time when spirometry
facilities are approved by NIOSH, any
person becoming a coal mine operator
on or after August 1, 2014, or any coal
mine operator without an approved plan
as of that date must submit a plan
within 60 days that provides for chest
radiographs and occupational histories
only.
(2) Coal mine operators with
previously approved plans for only
chest radiographs and occupational
histories, or with plans developed
pursuant to paragraph (a)(1) of this
section, will be notified by MSHA when
the plans must be amended to include
spirometry testing and respiratory
assessments. Amendments must be
submitted to NIOSH within 60 days of
MSHA’s notification.
(b) The coal mine operator’s plan
must include:
(1) The name, address, and telephone
number of the operator(s) submitting the
plan;
(2) The name, MSHA identification
number for respirable dust
measurements, and address of the mine
included in the plan;
(3) The proposed beginning and
ending date of the 6-month period(s) for
voluntary radiography exams and
spirometry tests (see §§ 37.3(a) and
37.92(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 radiograph and spirometry
facility or facilities, and the
approximate date(s) and time(s) of day
during which the radiograph
examination and spirometry will be
given to miners to enable a
determination of whether the
examinations will be conducted at a
convenient time and place;
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(5) If a mobile medical examination
facility is proposed to provide some or
all of the surveillance tests specified in
paragraph (a) of this section, the plan
must provide that each miner be given
adequate notice of the opportunity to
have the examination and that no miner
will have to wait for an examination
more than 1 hour before or after his or
her work shift. The plan must include:
(i) The number of change houses at
the mine.
(ii) One or more alternate non-mobile
approved medical examination facilities
for the reexamination of miners and for
the mandatory examination of miners
when necessary (see §§ 37.3(b) and
37.92(b)), or an assurance that the
mobile facility will return to the
location(s) specified in the plan as
frequently as necessary to provide for
medical surveillance examinations in
accordance with these regulations.
(iii) The name and location of each
change house at which examinations
will be given. For mines with more than
one change house, the examinations
must be given at each change house or
at a change house located at a
convenient place for each miner.
(6) Assurances that:
(i) The operator will not solicit a
physician’s spirometric, 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 spirograms or copies of
spirograms (including copies of
electronic files) and 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 all related
electronic files must be permanently
deleted from the facility records or
rendered permanently inaccessible
following the confirmed transfer of such
data to NIOSH, and that (except as may
be necessary for the purpose of this part)
the physician’s spirometric,
radiographic and other findings, as well
as the occupational history and
respiratory assessment information
obtained from a miner will not be
disclosed in a manner that would
permit identification of the individual
miner with his or her information; and
(iii) The spirometry and radiographic
examinations will be made at no charge
to the miner.
(c) Operators may provide for
alternate spirometry or radiography
facilities in plans submitted to NIOSH
for approval.
VerDate Sep<11>2014
18:21 Oct 21, 2016
Jkt 241001
(d) The change of operators of any
mine operating under a plan approved
pursuant to § 37.101(a) must not affect
the plan of the operator which has
transferred responsibility for the mine.
Every plan is subject to revision in
accordance with paragraph (e) of this
section.
(e) The operator must advise NIOSH
of any change in its plan. Each change
in an approved plan is subject to the
same review and approval as the
originally approved plan.
(f) The operator must promptly
display in a visible location on the
bulletin board at the mine its proposed
plan or proposed change in a NIOSHapproved plan when it is submitted to
NIOSH. The proposed plan or change in
a NIOSH-approved plan must remain
posted in a visible location on the
bulletin board until NIOSH either grants
or denies approval at which time the
approved plan or denial of approval
must be permanently posted. In the case
of an operator who does not have a
bulletin board, such as an operator that
is a contractor, the operator must
otherwise notify its employees of the
examination arrangements. Upon
request, the contractor must show
NIOSH written evidence that its
employees have been notified.
(g) Upon notification from NIOSH that
sufficient time has elapsed since the
previous period of examinations, the
operator must resubmit a plan for each
of its coal mines to NIOSH for approval
for the next period of examinations (see
§§ 37.3(a)(2) and 37.92(a)). The plan
must include the proposed beginning
and ending dates of the next period of
examinations and all information
required by paragraph (b) of this section.
■ 29. Revise § 37.101 to read as follows:
§ 37.101
Approval of plans.
(a) If, after review of any plan
submitted pursuant to this subpart,
NIOSH 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,
NIOSH will approve the plan and notify
the operator 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 NIOSH has reason to
believe that it will deny approval of a
plan NIOSH will, prior to the denial,
give notice in writing to the operator(s)
of an opportunity to amend the plan.
The notice must specify the ground(s)
PO 00000
Frm 00022
Fmt 4701
Sfmt 9990
upon which approval is proposed to be
denied.
(c) If a plan is denied approval,
NIOSH will advise the operator(s) in
writing of the reasons for the denial and
inform MSHA that the plan was denied.
■ 30. Revise § 37.102 to read as follows:
§ 37.102 Transfer of affected miner to less
dusty area.
(a) Any miner who, in the judgment
of NIOSH, has evidence of the
development of pneumoconiosis, must
be afforded the option of transferring
from his or her position to another
position in an area of the mine where
the concentration of respirable dust in
the mine atmosphere is in compliance
with the MSHA requirements in 30 CFR
part 90. A classification of one or more
of the miner’s chest radiographs as
showing 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 pneumoconiosis, or
complicated pneumoconiosis (ILO
Classification) will be accepted as such
evidence. NIOSH will, at its discretion,
also accept other medical examinations
provided to NIOSH for review, such as
computed tomography scans of the
chest or lung biopsies, as evidence of
the development of pneumoconiosis.
(b) Any transfer under this section
shall be in accordance with the
procedures specified in 30 CFR part 90.
■ 31. Revise § 37.103 to read as follows:
§ 37.103 Medical examination at miner’s
expense.
Any miner who wishes to obtain a
medical examination at the miner’s own
expense at an approved spirometry or
radiography 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
radiographic classification, evaluation
of spirometry test results, and reporting
of the results of examinations made at
the miner’s expense in the same manner
as if they were submitted under an
operator’s plan. Any change in the
miner’s transfer rights under the Act
that may result from this examination
will be subject to the terms of § 37.102.
Dated: October 4, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human
Services.
[FR Doc. 2016–24405 Filed 10–21–16; 8:45 am]
BILLING CODE 4163–19–P
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[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)]
[Rules and Regulations]
[Pages 73270-73290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24405]
[[Page 73269]]
Vol. 81
Monday,
No. 205
October 24, 2016
Part III
Department of Health and Human Services
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42 CFR Part 37
Specifications for Medical Examinations of Coal Miners; Final Rule
Federal Register / Vol. 81 , No. 205 / Monday, October 24, 2016 /
Rules and Regulations
[[Page 73270]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 37
[Docket No. CDC-2014-0011; NIOSH-276]
RIN 0920-AA57
Specifications for Medical Examinations of Coal Miners
AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Final rule.
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SUMMARY: With this action, the Department of Health and Human Services
(HHS), in accordance with recent rulemaking by the Department of
Labor's Mine Safety and Health Administration (MSHA), finalizes
amendments to Coal Workers' Health Surveillance Program regulations to
establish standards for the approval of facilities to conduct
spirometry and requires that all coal mine operators submit a plan for
the provision of spirometry testing and X-ray examinations to all
surface and underground coal miners.
DATES: This rule is effective on November 23, 2016.
FOR FURTHER INFORMATION CONTACT: A. Scott Laney, Research
Epidemiologist, Division of Respiratory Disease Studies, NIOSH, Centers
for Disease Control and Prevention, 1095 Willowdale Road, MS HG900.2,
Morgantown, WV 26505-2888; (304) 285-5754 (this is not a toll-free
number); alaney@cdc.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Public Participation
II. Background
A. History of Coal Workers' Health Surveillance Program and
Statutory Authority
B. Need for Rulemaking
III. Summary of Final Rule and Response to Public Comment
A. Subpart--Chest Radiographic Examinations
B. Subpart--Spirometry Examinations
C. Subpart--General Requirements
IV. Regulatory Assessment Requirements
A. Executive Orders 12866 and 13563
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
D. Small Business Regulatory Enforcement Fairness Act
E. Unfunded Mandates Reform Act of 1995
F. Executive Order 12988 (Civil Justice)
G. Executive Order 13132 (Federalism)
H. Executive Order 13045 (Protection of Children From
Environmental Health Risks and Safety Risks)
I. Executive Order 13211 (Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use)
J. Plain Writing Act of 2010
I. Public Participation
Interested persons or organizations were invited to participate in
this rulemaking by submitting written views, arguments,
recommendations, and data. Comments were invited on any topic related
to this rulemaking.
HHS received submissions to the docket from two commenters,
including a trade association representing coal mine operators and a
spirometry expert.
II. Background
A. History of Coal Workers' Health Surveillance Program and Statutory
Authority
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 coal workers'
pneumoconiosis (pneumoconiosis), silicosis, and chronic obstructive
pulmonary disease, including chronic bronchitis and emphysema.\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).
---------------------------------------------------------------------------
\1\ Edward L Petsonk and John E Parker, Coal Workers' Lung
Diseases and Silicosis, in Fishman's Pulmonary Diseases and
Disorders, 967 (Alfred P. Fishman ed., McGraw-Hill, 4th ed., 2008).
---------------------------------------------------------------------------
The National Institute for Occupational Safety and Health (NIOSH)
Coal Workers' Health Surveillance Program (CWHSP), also authorized by
the Mine Act, was established to detect pneumoconiosis and prevent its
progression in individual miners, while at the same time providing
information for evaluation of temporal and geographic trends in
pneumoconiosis. To inform each miner of his or her health status, the
Act requires that coal mine operators provide each miner who begins
work at a coal mine for the first time 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 a
coal mine must be offered a chest radiograph approximately every 5
years.
All chest radiographs and other supplemental tests deemed necessary
to protect the health and safety of U.S. coal miners are to be given in
accordance with specifications prescribed by the Secretary of Health
and Human Services (30 U.S.C. 843(a)). The Mine Act also grants the
Secretary, HHS general authority to issue regulations as is deemed
appropriate to carry out provisions of the Act (30 U.S.C. 957), and
grants NIOSH the authority to conduct activities in the field of coal
mine health on behalf of the Secretary, HHS (30 U.S.C. 951(b)).
B. Need for Rulemaking
On May 1, 2014, the Mine Safety and Health Administration (MSHA) in
the Department of Labor published a final rule amending existing health
and safety standards in 30 CFR part 72 to improve health protections
for coal miners, including the expansion of requirements for medical
surveillance.\2\ The amendments added a new section, Sec. 72.100, to
require that both underground and surface coal mine operators provide
to each miner chest X-rays and spirometry tests using facilities
approved by NIOSH, as well as the documentation of occupational history
and symptom assessment.
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\2\ 79 FR 24814.
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The expansion of MSHA's medical surveillance requirements caused
HHS to amend regulations in 42 CFR part 37 pertaining to the CWHSP,
thereby expanding the scope of the Program to include coal miners who
work in surface coal mines and adding spirometry testing and symptom
assessment for all miners. In response to MSHA's rulemaking, NIOSH
published an interim final rule on August 4, 2014 (August 2014 IFR) to
expand the existing CWHSP to provide chest radiographic examinations to
miners who work in surface coal mines and establish requirements for
spirometry testing for all coal miners under part 37.\3\ This action
finalizes those provisions promulgated by the August 2014 IFR.
---------------------------------------------------------------------------
\3\ 79 FR 45110.
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III. Summary of Final Rule and Response to Public Comment
This document finalizes the August 2014 IFR. The following section-
by-section summary describes and explains the amendments to certain
provisions of part 37. Public comments are also summarized and
answered. The final regulatory text is provided in the last section of
this document.
[[Page 73271]]
A. Subpart--Chest Radiographic Examinations
Section 37.1 Scope
Section 37.1 provides the scope of the provisions in Subpart--Chest
Radiographic Examinations, and is amended to clarify the purpose of
this subpart. Under this subpart, coal mine operators are required to
provide radiographic examinations to each current and new coal miner,
using medical facilities approved by NIOSH according to the standards
established in this subpart. Because no comments were submitted on this
section and no changes are made to the regulatory text, this section is
not included in the regulatory text below.
Section 37.2 Definitions
Section 37.2 contains definitions for terms that appear throughout
this subpart and the new subparts (Subpart--Spirometry Testing and
Subpart--General Requirements). The existing definitions of several
terms are revised and a new definition of ``B Reader'' is added, as
discussed below.
The definition ``Act,'' which refers to the Federal Mine Safety and
Health Act of 1977, is revised to include reference to the Public Law
number and amendments.
The definition ``convenient time and place'' is revised to strike
the phrase ``with respect to the conduct of any examination under this
subpart,'' because that phrase is not used in part 37. Additional
language is added to clarify how this term is to be interpreted.
Although this definition was not included in the August 2014 IFR,
revising it to be consistent with the language in Sec. Sec. 37.40 and
37.100 is thus a logical outgrowth of this rulemaking.
The definition ``digital radiography systems'' is changed to
replace the word ``X-ray'' with ``radiographic.'' Although this
definition was not included in the August 2014 IFR, revising it is
consistent with changes made to Sec. 37.51 in this final action and is
thus a logical outgrowth of this rulemaking.
The definition ``ILO Classification'' is revised to clarify that
using the term ``digital chest image file'' includes all electronic
standard chest images included in the set of film radiographs provided
by the International Labour Office (ILO) in the International
Classification of Radiographs of Pneumoconioses. The definition is also
revised to recognize that NIOSH must approve other sets of chest images
files as equivalent to the ILO Classification. The ILO Classification
is incorporated by reference into certain sections in part 37. Although
this definition was not included in the August 2014 IFR, revising it to
recognize digitized image files is consistent with changes made to
Sec. 37.51 in this final action, and is thus a logical outgrowth of
this rulemaking.
The definition ``NIOSH'' is revised to replace the former name of
the NIOSH division responsible for the CWHSP with its new name,
Respiratory Health Division (RHD). RHD is the organizational unit
within NIOSH responsible for administration of the CWHSP.
The definition ``Panel of B Readers'' is revised to clarify that B
Readers are certified by NIOSH and classify or otherwise evaluate
radiographs for the CWHSP.
The definition ``radiologic technologist'' is revised to clarify
terminology by replacing ``chest images'' with ``chest radiographs.''
A new definition of ``B Reader'' is added to direct readers to
Sec. 37.52, which requires physicians who wish to evaluate and
classify chest radiographs for pneumoconiosis to take and pass a
specially designed proficiency examination given by NIOSH. This
definition is predicated on existing language in Sec. 37.52, and is
thus a logical outgrowth of the August 2014 IFR.
Finally, the definition ``facility'' is moved from Sec. 37.91 and
is unchanged. No comments were submitted on this section.
Section 37.3 Chest Radiographs Required for Miners
Section 37.3 requires mine operators to provide miners an
opportunity to receive a chest radiograph. Paragraphs (a)(1) and (2),
concerning the provision of each employed miner an opportunity for a
chest radiograph at least 3.5 to 4.5 years after the previous period
for the conduct of such examinations, are revised to eliminate
redundancy and provide greater clarity regarding the deadlines for
voluntary examinations. The sentence specifying that the period during
which examinations must begin is removed because it does not provide
any additional information and may be confusing. The example provided
in paragraph (a)(2) is also removed for similar reasons.
No changes are made to paragraph (b), which establishes the
periodicity of three required initial chest radiographs. Paragraph (c),
which establishes that NIOSH will notify the miner when it is time for
a second or third radiography examination and will notify the operator
under certain circumstances, is revised for clarity.
Paragraph (d), concerning the availability of chest radiographs, is
revised to replace ``subpart'' with ``part'' to clarify that
radiographs must be made available by an operator in accordance with a
plan submitted and approved by NIOSH in accordance with this part. As
discussed in the August 2014 IFR, the section requiring operator plans
for medical examinations has been removed from this subpart and
replaced in Subpart--General Requirements.
One commenter asked that HHS require miners to submit to mandatory
respiratory examinations. NIOSH does not have legal authority to
require coal miners to submit to medical examinations. Although section
203(a) of the Mine Act (30 U.S.C. 843(a)) states that medical
examinations shall be given to miners at certain intervals, it states
elsewhere in that section that miners are to have ``the opportunity''
to have such examinations. Moreover, NIOSH concurs with MSHA's
position, as addressed in the agency's May 1, 2014 final rule in
response to public comment, that requiring miners to submit to medical
examinations against their will would not be appropriate.\4\ No changes
are made to the regulatory text in response to public comment.
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\4\ See MSHA final rule, 79 FR 24814, at 24928 (May 1, 2014).
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Section 37.4 Chest Radiographic Examinations Conducted by the Secretary
Section 37.4 details the conditions under which the HHS Secretary
will determine whether to conduct a chest radiographic examination.
Paragraph (a), which details the circumstances under which the
Secretary, HHS, will arrange for chest radiographs at a particular
mine, is unchanged.
``Shall'' is replaced with ``must,'' in accordance with Federal
plain language guidelines, in paragraph (b), which requires the
operator to reimburse the Secretary or person, agency, or institution
directed by the Secretary to conduct radiography examinations, and
paragraph (c), which requires the examinations arranged by the
Secretary to be given according to the periodicity requirements in
Sec. 37.3.
Paragraph (d), which stipulates that operators participating in the
National Study of Coal Workers' Pneumoconiosis would not be responsible
for assuming the cost of providing chest radiographs, is removed in its
entirety because that study no longer exists. No comments were
submitted on this section and no changes are made to the regulatory
text.
Section 37.10 Standards Incorporated by Reference
Section 37.10 provides references to the standards incorporated by
reference
[[Page 73272]]
into part 37. This section is amended slightly to update the name of
the NIOSH Division of Respiratory Disease Studies, now known as the
Respiratory Health Division. The link to the American College of
Radiology publication has been updated. No public comment was received
and no further edits are made to this section.
Section 37.20 Miner Identification Document
Section 37.20 requires the use of a Miner Identification Document
as a component of the examination. Although this section was not
amended by the August 2014 IFR, revising it here is consistent with the
addition of spirometry to part 37, and is thus a logical outgrowth of
this rulemaking. The text is revised slightly to reference both
radiographic and spirometry examinations. The section is also changed
to clarify that the form (CDC/NIOSH 2.9) is required for both types of
examination.
Section 37.40 General Provisions
Section 37.40 outlines general provisions for chest radiographs.
Paragraphs (a) and (c), which require that the radiographic examination
must be given at a convenient time and place and performed in an
approved facility, respectively, are unchanged. Paragraph (b) is
revised to update the name of the completed form that must accompany
the chest radiographic examination, the Chest Radiograph Classification
Form (CDC/NIOSH 2.8). No comments were submitted on this section.
Section 37.43 Approval of Radiographic Facilities That Use Film
Radiography Systems
Section 37.43 establishes standards for the approval of radiography
facilities that use film. Although this section was not included in the
August 2014 IFR, revisions are a logical outgrowth of other changes
throughout the part. The section heading is revised to clarify that it
applies to film radiography systems. Paragraph (a), concerning
application to NIOSH for facility participation in the CWHSP, is
unchanged except to divide it into smaller paragraphs for clarity.
Paragraph (a)(1) concerns the submission of sample radiographs made on
the equipment intended to be used to perform radiographs under this
part; (a)(2) concerns the submission of sample radiographs within 15
days of being made; (a)(3) concerns the return of such radiographs
submitted as a component of the A Reader approval process. The
reference provided for those chest radiographs is corrected to read
Sec. 37.52(a)(2)(i).
The name of the form referenced in paragraph (b), the Radiographic
Facility Certification Document, is updated to be consistent with
updates in other sections of Part 37.
Paragraphs (c), (d), and (f), concerning the evaluation of
radiographs submitted with applications for NIOSH approval, the
inspection of the applicant facility by NIOSH, and the establishment of
a quality assurance program at the applicant facility, respectively,
are unchanged.
The name of the form referenced in paragraph (e), the Radiographic
Facility Certification Document, is updated to be consistent with
updates in other sections of part 37. The paragraph is also divided
into smaller paragraphs for clarity. Paragraph (e)(1) now concerns the
suspension or withdrawal of NIOSH approval of a radiograph facility;
paragraph (e)(2) requires a copy of a withdrawal notice be displayed on
the mine bulletin board.
In paragraph (g), concerning the maintenance of records in
accordance with Federal privacy laws, the word ``interpretations'' is
replaced with ``classifications,'' to clarify that B Readers are
responsible for recording classifications on the Chest Radiograph
Classification Form (CDC/NIOSH 2.8). The term ``classifications''
describes surveillance activities, such as providing standardized
descriptions of chest radiographs, while ``interpretations'' is a
broader term meant to describe clinical activities, such as assessing
radiographic findings and generating radiological differential
diagnoses. This revision is consistent with similar changes in other
sections of part 37.
Section 37.44 Approval of Radiographic Facilities That Use Digital
Radiography Systems
Section 37.44 establishes standards for the approval of radiography
facilities that use digital radiography. Although this section was not
included in the August 2014 IFR, the new organization and content
revisions are a logical outgrowth of other changes throughout the part.
Paragraph (a), concerning application to NIOSH for facility
participation in the CWHSP, is unchanged. Paragraph (a)(1), regarding
the submission of digital radiographic image files with an application
for facility approval, is redesignated as paragraph (a) and divided
into smaller paragraphs for clarity. Paragraph (a)(1) now concerns the
submission of image files; (a)(2) concerns the submission of images
within 60 days of the application date; (a)(3) concerns the
documentation that must accompany the image files; and (a)(4) concerns
the orientation of submitted images.
Paragraph (a)(2) is redesignated as paragraph (b). The name of the
form referenced in paragraphs (b) and (e), the Radiographic Facility
Certification Document, is updated to be consistent with updates in
other section of part 37; similarly, the word ``X-ray'' is replaced
with ``radiograph'' in paragraph (g)(2).
Paragraphs (b), (c), (e), (f), and (h), concerning facility
licensure, physical inspections by NIOSH, the medical physicist
requirement, documentation of compliance, and maintenance of records in
accordance with Federal privacy laws are redesignated as paragraphs
(c), (d), (e), (f), and (i), respectively.
Paragraph (g)(2), regarding radiation exposure parameters, is
redesignated as paragraph (h)(2) and is divided into smaller paragraphs
for clarity. Paragraph (h)(2)(i) now concerns the monitoring of
radiological exposures; paragraph (h)(2)(ii) now concerns annual
assessments of radiation exposures conducted by a medical physicist.
The substance of paragraph (h) is otherwise unchanged.
Section 37.50 Interpreting and Classifying Chest Radiographs--Film
Radiography Systems
Section 37.50 establishes procedures for the classification of film
radiographs. The section heading is revised to clarify that the
procedures herein apply specifically to film radiography systems.
Paragraphs (a), which requires radiographs to be interpreted in
accordance with the ILO Classification, and (c), which requires those
interpreting chest radiographs to have a complete set of standard
radiographs for use with the ILO Classification immediately available
for reference, are unchanged.
Paragraph (b) requires radiographs to be interpreted and classified
by physicians who read chest radiographs in the normal course of
practice and who have demonstrated proficiency in classifying
pneumoconiosis in accordance with the standards in Sec. 37.52. Non-
substantive revisions to the regulatory text in paragraph (b)(1), which
requires that interpretations of findings other than pneumoconiosis
must be provided by a qualified physician who provides these services
for the examining facility, clarify that the physician must have all
required licensure and privileges and must interpret chest radiographs
in the normal course of his or her practice.
Paragraph (c), which requires all interpreters to have immediately
available a set of standard radiographs
[[Page 73273]]
for use with the ILO Classification, is unchanged.
Paragraph (d), which establishes standards for view boxes, is
revised to clarify that view boxes must comply with the requirements in
paragraphs (d)(1)-(4). No comments were submitted on this section.
Section 37.51 Interpreting and Classifying Chest Radiographs--Digital
Radiography Systems
Section 37.51 establishes procedures for the classification of
digital chest radiographs. Paragraph (a), which requires that
significant abnormal findings other than pneumoconiosis must be
initially interpreted and notification provided by a qualified
physician, is not changed in this action.
Paragraph (b), requiring that classifications be made by B Readers
and recorded on a Chest Radiograph Classification form, is revised to
clarify that physician readers who have demonstrated proficiency in the
classification of pneumoconiosis in accordance with Sec. 37.52(b) are
B Readers. The paragraph is also changed to remove the term
``interpretations,'' for the reasons discussed above.
Paragraph (c), which requires B Readers to have a complete set of
NIOSH-approved standard digital radiographs for use with the ILO
Classification immediately available for reference, is changed to
clarify that NIOSH-approved digital standard images used for making
classifications include all approved electronic standard chest images,
thus encompassing the current digitized standard chest radiographs
provided by ILO. This paragraph is also divided into smaller paragraphs
to aid the reader; no substantive changes are made. Paragraph (c)(1)
now concerns the use of only NIOSH-approved standard digital images for
classification; (c)(2) prohibits the modification of the appearance of
the standard images.
Paragraphs (d) through (g), which concern viewing systems, quality
control for display devices, use of soft copy images, and the
impermissibility of classifications based on digitized copies of chest
radiographs are also unchanged. No comments were submitted on this
section.
Section 37.52 Proficiency in the Use of Systems for Classifying the
Pneumoconioses
Section 37.52 establishes the A and B Reader approval programs.
Paragraph (a) establishes standards for the approval of A Readers;
paragraph (a)(1), which allows A Reader approvals to continue if
established prior to October 15, 2012, is changed to clarify that the
approval continues indefinitely. Paragraph (a)(2) details the
requirements for becoming a NIOSH-approved A Reader; paragraph (i),
which requires the submission of six properly-classified sample
radiographs, is revised to remove the word ``interpretations'' and
replace it with ``classifications,'' and to update the name of the form
to Chest Radiograph Classification Form (CDC/NIOSH 2.8), for the
reasons discussed above. Paragraph (a)(2)(ii), requiring the completion
of a NIOSH-approved ILO Classification course in lieu of the six sample
radiographs referenced in paragraph (a)(2)(i), is unchanged.
Paragraph (b), which establishes standards for the approval of B
Readers, and paragraph (b)(1), which establishes that B Reader
approvals received prior to October 1, 1976 are terminated, are
unchanged. Paragraph (b)(2) requires that physicians pass a proficiency
examination in order to be approved as a NIOSH B Reader and is revised
to clarify that B Reader proficiency examinations are only given on
behalf of or by NIOSH. This paragraph is also revised to divide the
large paragraph into smaller paragraphs; no substantive revisions are
made. Paragraph (b)(2)(i) now concerns the provision of a complete set
of NIOSH-approved standard reference digital radiographs to physicians
taking the B Reader exam; (b)(2)(ii) states that physicians who qualify
as B Readers need not be qualified as A Readers.
Paragraph (c) requires physicians who wish to participate in the
CWHSP to apply to NIOSH. The name of the form is changed to Physician
Application for Certification; the paragraph is otherwise unchanged. No
comments were submitted on this section.
Section 37.53 Method of Obtaining Definitive Chest Radiograph
Classifications
Section 37.53 establishes the method used by NIOSH to obtain
definitive classifications of chest radiographs. For the reasons
discussed above, the name of this section is revised to replace
``interpretations'' with ``chest radiograph classifications,'' to
clarify that B Readers provide classifications according to the ILO
system for classifying radiographs. Paragraph (a) establishes that
radiographs will be independently classified by an A Reader and B
Reader or two B Readers, or if agreement is lacking, NIOSH will obtain
a third classification. This paragraph is revised to clarify that B
Readers are qualified by NIOSH pursuant to Sec. 37.52, and is also
divided into smaller paragraphs to aid the reader. Paragraph (a)(1) now
concerns agreement among the two classifications; (a)(2) concerns the
procedure NIOSH follows when agreement is lacking, and is further
divided into smaller paragraphs. Paragraph (a)(2)(i) concerns agreement
between two of three classifications resulting in a final
determination; (a)(2)(ii) concerns lack of agreement among three
classifications. No other changes are made to this paragraph.
Paragraph (b), which establishes what NIOSH considers to be
agreement between chest radiographs, is revised to clarify that two
classifications are considered to be in agreement when they meet the
standards now in paragraphs (b)(1), (2), and (3). Paragraph (b)(3),
which contains the current standard for a determination of simple
pneumoconiosis, is further divided into smaller paragraphs (i) and (ii)
and is revised slightly to comport with the new structure. No comments
were submitted on this section.
Section 37.54 Notification of Abnormal Radiographic Findings
Section 37.54 requires that findings of abnormalities identified by
chest radiograph be communicated to the miner. Although this section
was not included in the August 2014 IFR, the revisions discussed below
are consistent with other changes in this final action.
A new heading is added to clarify the intent of paragraph (a),
which provides that findings suggesting heart abnormalities,
tuberculosis, lung cancer, or any other significant health condition
other than pneumoconiosis must be communicated to the miner or the
miner's designated physician. The paragraph is also rearranged to
clarify that the first physician to interpret a miner's radiograph must
communicate the findings.
A new heading is added to clarify the intent of paragraph (b),
which provides that NIOSH will arrange for a physician to compare a
recent radiograph found to show significant abnormal findings,
including pneumoconiosis, with older images that NIOSH may have in its
possession. The word ``interpretation'' is removed from this paragraph
to clarify that NIOSH will arrange for a physician to compare the most
recent image showing an abnormality to older images. This change is
consistent with other similar changes throughout part 37, for the
reasons discussed above.
A new heading is added to paragraph (c), to clarify the intent of
the paragraph regarding notice to the miner of eligibility for Part 90
transfer rights. The term ``final findings'' is replaced with ``final
determinations,'' which are reported to the miner or the miner's
[[Page 73274]]
designated physician by NIOSH, when such determinations provide
evidence for the development of pneumoconiosis. Revisions also clarify
that NIOSH will coordinate with MSHA regarding notification of part 90
eligibility.
Finally, a heading is added to clarify the intent of paragraph (d),
which states that NIOSH makes every effort to process pneumoconiosis
determinations within 60 days of receipt of chest radiograph images and
other documents. The paragraph is also divided into smaller paragraphs
to aid the reader. Paragraph (d)(1) now concerns timely notice by MSHA;
this paragraph is revised to clarify that NIOSH will work with MSHA to
provide notice within the 60-day timeframe established in paragraph
(d). Paragraph (d)(2) now states that examination results may not be
processed by NIOSH if the examination was made within 6 months of the
date of a prior acceptable examination.
One public commenter recommended that this section be changed to
allow the results of the radiography examinations and spirometry to be
made available to a health professional designated by the mine
operator. According to the commenter, because operators are required to
establish a plan for the examinations and pay for them, they are
entitled to have access to the results. The commenter argued that
section 203 of the Mine Act (30 U.S.C. 843) does not support excluding
mine operators from the notification requirements in this section or in
the spirometry results notification requirements in the new Sec.
37.97. According to the commenter, the decision to not provide
examination results to mine operators is inconsistent with a 2006 NIOSH
guidance document concerning refractory ceramic fibers and with the DOL
Occupational Safety and Health Administration (OSHA) asbestos
standards, both of which allow notification of employers. Further,
according to the commenter, section 103(h) of the Mine Act provides for
the sharing of reports and findings to any interested person. Finally,
the commenter argued that sharing the examination findings with
operators would allow the operators to provide health counseling and
medical management to miners showing evidence of early disease.
NIOSH declines to make results of radiography or spirometry
available to either mine operators or health professionals designated
by operators. Section 203 of the Mine Act specifically identifies the
parties that must be notified of examination results (i.e., Secretary,
DOL; Secretary, HHS; miner; and miner's designated physician). NIOSH is
not authorized to expand notification to mine operators. Section 103 of
the Mine Act, referenced by the commenter and described above, is not
relevant to the matter of medical examinations of individual miners
because it only addresses the conduct of mine inspections. Finally,
NIOSH concurs with MSHA in its response to the question of providing
examination results to operators, published in MSHA's 2014 final rule
on respirable coal mine dust, which explained that the individuals
notified of the miner's test results are limited in order to protect
miners' confidentiality and uphold Federal privacy laws.\5\
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\5\ See 79 FR 24814, at 24928 (May 1, 2014).
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Section 37.60 Submitting Required Chest Radiographs and Miner
Identification Documents
Section 37.60 establishes the protocol for submitting radiographs
to NIOSH. Paragraph (a) is revised to clarify that all submitted items,
including each required chest radiograph, the Chest Radiograph
Classification form, and the Miner Identification Document, become the
property of NIOSH. Paragraph (a)(1) is further revised to remove the
redundant sentence concerning the 14-day deadline for submission of
documents after the date of the radiographic examination. The sentence
concerning NIOSH's notification to the submitting facility of receipt
of image files and forms is moved into paragraph (a)(2).
Paragraph (b) is revised to clarify that the operator must arrange
for reexamination at no expense to the miner, in the event that NIOSH
finds any submission to be inadequate.
Paragraph (c), which establishes that failure to comply with
paragraph (a) or (b) may result in revocation of approval of a plan, is
unchanged, as is paragraph (d), which states that chest radiographs and
required forms must only be submitted for miners.
Paragraph (e) is revised to replace ``shall'' with ``must'' or
``will'' throughout the paragraph in accordance with Federal plain
language guidelines. References in this paragraph concerning the
collection of Social Security numbers are revised slightly to clarify
that only the last four digits are required by NIOSH; this change is
not substantive and reflects current Program practice. No comments were
submitted on this section.
Section 37.70 Review of Classifications
Section 37.70(a) establishes that a miner may request that NIOSH
reevaluate a pneumoconiosis classification that the miner believes is
in error. The section heading is changed to replace ``interpretations''
with ``classifications,'' consistent with previous edits discussed
above. The paragraph is also divided into smaller paragraphs to aid the
reader. Paragraph (a)(1) establishes that after a written request from
a miner, NIOSH will obtain one or more additional classifications by B
Readers if the contested classification was based on agreement between
an A Reader and a B Reader, pursuant to Sec. 37.53. A reference in
this paragraph to the section in part 37 that addresses the transfer of
miners to a less dusty area is corrected to read Sec. 37.102.
Paragraph (a)(2) establishes that a classification based on agreement
between two or more B Readers will be considered final and will be not
be reevaluated. No comments were submitted on this section and no other
changes are made to the regulatory text.
Sec. 37.80 Availability of Records for Radiographs
Section 37.80 requires that written consent be provided to NIOSH
for the release of medical information and radiographs. This section
was not included in the August 2014 IFR, but is revised in this final
action to clarify that original film radiographs are available for
examination at the NIOSH facility in Morgantown, WV. No comments were
submitted on this section.
B. Subpart--Spirometry Testing
This subpart establishes standards for spirometry testing for all
coal miners, working in both underground and surface mines. As
discussed in the August 2014 IFR, the provisions in this subpart are
consistent with MSHA regulations in 30 CFR 72.100, which requires that
operators offer periodic spirometry and respiratory assessments to
document miner respiratory symptoms and lung function. This is in
addition to chest radiographic examinations and occupational history
questionnaires. The subpart heading is revised to replace the word
``examinations'' with the word ``testing,'' and similar changes are
made throughout the subpart to reflect the correct terminology for
describing spirometry.
Section 37.90 Scope
Section 37.90 provides the scope of the provisions in Subpart--
Spirometry Testing. The text of this section is changed slightly to
clarify that operators are required to provide spirometry testing to
both current and newly
[[Page 73275]]
employed coal miners. No comments were submitted on this section.
Section 37.91 Definitions
Section 37.91 defines terms used in this subpart. Several revisions
are made to this section. The definition ``facility'' is removed,
unchanged, from this section and moved to the definitions section in
Sec. 37.2.
The definition ``FET'' is revised to clarify that forced expiratory
time is the time from the beginning of a forced exhalation maneuver to
the end of the expiration.
The definition ``FEV1'' is revised to clarify that forced
expiratory volume in one second is the greatest volume of air that can
be forcibly blown out within the first second after full inspiration.
A new definition of the FEV1/FVC is added to mean the ratio between
the largest acceptable FEV1 and the largest acceptable FVC following
the forced vital capacity maneuver.\6\ Although this definition was not
included in the August 2014 IFR, it is considered to be a logical
outgrowth of this rulemaking. (See Sec. 37.96(b)(1).)
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\6\ See Gregg L. Ruppel, Manual of Pulmonary Function Testing,
51 (St. Louis: Mosby Inc., 9th ed., 2009).
---------------------------------------------------------------------------
The existing definition of ``FEV6'' is revised to clarify that
forced expiratory volume in six seconds is the greatest volume of air
that can forcibly be blown out in six seconds after full inspiration.
The existing definition of ``FVC'' is revised to clarify that
forced vital capacity is the greatest volume of air that can forcibly
be blown out after full inspiration.
The existing definition of ``PEF'' is revised to clarify that peak
expiratory flow is the maximal airflow generated during a forced vital
capacity maneuver.
No comments were submitted on this section.
Section 37.92 Spirometry Testing Required for Miners
Section 37.92 requires coal mine operators to provide all miners an
opportunity to receive spirometry testing. Paragraph (a), which
requires that each operator must provide an opportunity for miners to
perform spirometry testing at least once every 5 years, is unchanged
except for the heading, in which ``Voluntary examinations'' is replaced
with ``Voluntary tests.''
Paragraphs (b)(1), (2), and (3) establish the periodicity of
initial, second, and third spirometry tests. The headings for the lower
subparagraphs, ``Initial spirometry examination,'' ``Second
examination,'' and ``Third examination'' are removed to mirror the
structure of Sec. 37.3, ``Chest radiographs required for miners.'' The
word ``examination(s)'' is replaced with ``test(s)'' throughout all
three. Paragraph (b)(3) is revised to clarify that a third spirometry
test and respiratory assessment will be provided if the second
spirometry test results demonstrate more than a 15 percent age adjusted
decline in the percent predicted FEV1 value since the initial baseline
test. This paragraph is also divided into smaller paragraphs to aid the
reader; the two new sub-paragraphs clarify how the percent predicted
FEV1 value will be calculated (paragraph (b)(3)(i)) and the appropriate
correction factor for calculating the percent predicted FEV1 for an
individual of Asian descent (paragraph (b)(3)(ii)). One comment was
received on paragraph (b)(3), supporting the decision to establish the
15 percent decline in the percent predicted FEV1 value.
Paragraph (c) establishes notification requirements for second and
third spirometry testing sessions. This paragraph is also divided into
smaller paragraphs to aid the reader. Paragraph (c)(1) stipulates that
the operator would be notified of a miner's eligibility for a third
spirometry test only with the consent of the miner. If the operator is
notified, NIOSH will not specify the medical reason for the third test
nor reveal that it is the miner's third. Paragraph (c)(2) establishes
that if the miner is notified of the time for a third test and the
operator is not notified, provision for the test in the NIOSH-approved
operator's plan will constitute the operator's compliance with this
requirement; no changes are made to the text of this paragraph.
No revisions are made to paragraph (d) and no other public comment
was received on this section.
Section 37.93 Approval of Spirometry Facilities
Section 37.93 establishes standards by which NIOSH approves
facilities that conduct spirometry tests, including ensuring that
spirometry results are of adequate quality, and specifying programmatic
approaches to quality assurance and addressing deficiencies. Paragraph
(a) requires that NIOSH-approved facilities be able to provide
spirometry of high technical quality by meeting the standards in this
subpart. The paragraph is revised to replace the term ``spirometry
examinations'' with the more common ``spirometry testing,'' and to
remove the link to the Spirometry Facility Certification Document to
avoid incorrect information if the NIOSH Web site is updated.
Paragraph (b) establishes that a spirometry quality assurance
program must be in place at the facility to minimize the rate of
invalid test results. Paragraph (b)(1) requires instrument calibration
checks, performed in accordance with the 2005 ATS/ERS Standardisation
of Spirometry guidelines. The regulatory text is revised to clarify
that instrument calibration check records must be maintained by the
facility and available for inspection by NIOSH, as deemed necessary.
One public commenter stated that the calibration check procedures as
described in the proposed rule were most relevant to volume
spirometers, which are no longer being produced and are increasingly
unavailable for purchase. In response to the public comment, the
regulatory text in paragraph (b)(1) is revised and divided into smaller
paragraphs to clarify which calibration check procedures are expected
for volume spirometers (paragraph (b)(1)(i)) and flow-type spirometers
(paragraph (b)(2)(ii)). These procedures are consistent with guidance
cited by the commenter and published by the Occupational Safety and
Health Administration.\7\ A new paragraph (b)(1)(iii) contains the
existing sentence regarding the retention and maintenance of instrument
calibration check records, and is changed to clarify that records will
be available for inspection by NIOSH, as deemed necessary.
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\7\ Occupational Safety and Health Administration, U.S.
Department of Labor, Spirometry Testing in Occupational Health
Programs: Best Practices for Healthcare Professionals, OSHA 3637-03
2013, https://www.osha.gov/Publications/OSHA3637.pdf.
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Paragraph (b)(2) requires automated maneuver and test session
quality-checks. The paragraph is revised to clarify that the screen
displayed error messages must alert the technician to maneuver
acceptability and test session non-repeatability. The paragraph is also
revised to clarify that each spirometry test session must have the goal
of obtaining 3 acceptable with 2 repeatable forced vital capacity
maneuvers. A public commenter also expressed concern that technicians
understand that although the error messages referenced in paragraph
(b)(2) are helpful, they are unreliable and cannot be relied on alone
to evaluate and determine test validity. NIOSH agrees that technicians
should not rely on the equipment alone to alert them of testing errors.
Accordingly, Sec. 37.95(a) requires all providers who collect
spirometry data to successfully complete a NIOSH-approved spirometry
training course. The spirometry course curriculum includes the
identification and
[[Page 73276]]
correction of technical and subject performance errors.\8\ Course
participants are given additional curriculum materials to use as guides
for correcting these testing errors, which they can retain for future
reference in their clinics.\9\ Paragraph (b)(2) is not changed in
response to the public comment.
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\8\ See Spirometry: What is the Design and Content of an
Approved Course? https://www.cdc.gov/niosh/topics/spirometry/content-approved-course.html.
\9\ See NIOSH, Get Valid Spirometry Results EVERY Time, DHHS
(NIOSH) Publication No. 2011-135, March 2011, https://www.cdc.gov/niosh/docs/2011-135/, and NIOSH, Spirometry Quality Assurance:
Common Errors and Their Impact on Test Results, DHHS (NIOSH)
Publication Number 2012-116, January 2012, https://www.cdc.gov/niosh/docs/2012-116/default.html.
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Paragraph (b)(3) requires ongoing monitoring of spirometry test
quality. The paragraph is revised to clarify that NIOSH may provide
quality performance feedback to the spirometry technician(s). The word
``examination,'' used to characterize spirometry data, is removed from
paragraph (b)(4), which concerns quality assurance audits.
The word ``as'' is inserted into paragraph (c), which concerns
noncompliance, to improve the first sentence; the word ``examination''
is removed, for the reasons discussed above. Paragraph (d), revocation
of approval, is unchanged.
Finally, in paragraph (e), references to chest radiographs are
removed and/or changed to reference spirometry tests, in keeping with
the theme of this subpart. These changes include replacing the term
''medical examinations'' with ``spirometry tests'' and removing the
reference to radiograph examinations, classifications, and images.
Section 37.94 Respiratory assessment form
Section 37.94 requires that a respiratory assessment form must be
completed for each miner upon testing. The link to the form on the
NIOSH Web site is removed and the word ``examination'' is replaced with
``testing.'' No comments were submitted on this section.
Section 37.95 Specifications for Performing Spirometry Tests
Section 37.95 establishes standards for the performance of
spirometry tests; the term ``examinations'' is replaced with ``tests''
in the section heading. Paragraph (a) of this section requires that
persons administering spirometry tests for the CWHSP demonstrate
completion of NIOSH-approved spirometry training, and maintain their
knowledge by periodically completing an approved refresher course. The
paragraph is revised to remove the link to the Spirometry Results
Notification Form.
Paragraph (b) establishes specifications for the spirometry testing
equipment used to conduct tests pursuant to this Part. A public
commenter recommended that the real-time displays should be large in
order to allow the technician to quickly identify issues with the
tests. NIOSH agrees with the commenter's concern and has required that
spirometry testing equipment conform with the 2005 ATS/ERS
Standardisation of Spirometry specifications for graphics (real-time
displays and test reports), which should be a minimum size for the
proper recognition of errors and acceptability of test maneuvers. As
part of the approval process, clinics are required to provide
information pertaining to spirometer manufacturer, model, and serial
number for each spirometer used during miner testing. This spirometer
information allows NIOSH to confirm that the system display meets
minimum requirements. No changes are made to paragraph (b).
Paragraph (c) specifies certain required documents and procedures
during performance of spirometry testing, including the pre-test
checklist, Respiratory Assessment form, collection of anthropometric
and demographic information, and the spirometry procedure itself, which
must be conducted in accordance with testing procedures described in
the 2005 ATS/ERS Standardisation of Spirometry and the 2010
Standardisation of Lung Function Testing, authors' replies to readers'
comments, which are incorporated by reference. The paragraph is revised
to include a new paragraph (c)(1), which clarifies that the Miner
Identification Document described in Sec. 37.20 must be completed for
each miner at the facility where spirometry is performed; the remaining
numbered paragraphs are re-numbered accordingly. In the paragraphs now
designated (c)(2) and (3), which require completion of the pre-test
checklist and the Respiratory Assessment form, respectively, the links
to those documents are removed, for the reason discussed above.
Paragraph (c)(4), which requires the collection of anthropometric and
demographic information, is revised to clarify that the data must
either be entered into the facility's computer and transmitted
electronically with the spirometry data file or submitted, if required
under the facility's approval, on the Spirometry Results Notification
form. Language concerning spirometry equipment that does not permit
electronic transfer of data files is removed because all facilities
that are approved to participate in the CWHSP will submit spirometry
data electronically, whether in the form of spirometry data files or in
the form of a completed Spirometry Results Notification Form (CDC/NIOSH
2.15) accompanied by a spirometry report PDF that contains graphics for
NIOSH inspection of FVC maneuver quality. The paragraph (c)(5) heading
is revised to clarify that the topic of the paragraph is test
procedures.
Paragraph (d), concerning the submission of test results by the
approved facility to NIOSH, is removed because it is redundant.
Requirements for the submission of spirometry results to NIOSH are
consolidated in Sec. 37.96(c).
No changes are made to former paragraph (e), now designated
paragraph (d), concerning records retention, other than to substitute
``test'' and ``sessions'' for ``examination'' and ``examinations,'' and
no other public comments were received on this section.
Section 37.96 Spirometry Interpretations, Reports, and Submission
Section 37.96 establishes requirements for the interpretation of
spirometry test results, as well as specifications for the content,
deletion, and transmission of test reports. The heading of this section
is revised to replace the word ``notifications'' with ``submission'' to
reflect a reorganization of this section, discussed below.
Paragraph (a) of this section requires qualified health care
professionals at the facilities to interpret results using a
standardized approach, described in the 2005 ATS/ERS Interpretative
Strategies for Lung Function Tests, and the 2014 Official ATS
Standards: Spirometry in the Occupational Setting, which are
incorporated by reference. No changes are made to paragraph (a).
Paragraph (b) specifies the content of spirometry test reports and
the deletion of files and forms associated with the testing. The title
of paragraph (b) is edited for clarity, ``Spirometry reports at NIOSH-
approved spirometry facilities.'' The phrase ``at a minimum'' is
removed from paragraph (b)(1) to clarify that spirometry reports must
contain the elements listed in this paragraph. Paragraph (b)(1) is also
divided into smaller paragraphs to clarify the required elements, and
revised by adding the word ``threshold'' to describe the lower limit of
normal values required. Paragraph (b)(2) is unchanged.
The language in paragraph (c), which requires that findings are
communicated to the miner or the miner's designated physician, is moved
from Sec. 37.96 to a new Sec. 37.97; the existing section
[[Page 73277]]
containing references to documents incorporated by reference into this
subpart is renumbered Sec. 37.98. The notifications to miners section,
public comment, and NIOSH response to comment are discussed below.
With the removal of the language in paragraph (c), paragraph (d),
concerning the submission of spirometry results to NIOSH, is
redesignated paragraph (c). The text in this paragraph is revised to
clarify that each facility must submit spirometry results and completed
forms to NIOSH within 14 days of a spirometry test. The link to the
Spirometry Notification Form is removed, as discussed above, and the
name of the form is corrected. This paragraph is divided into smaller
paragraphs to aid clarity. Paragraph (c)(1) concerns the submission of
spirometry test results in the form of an electronic data file. CWHSP
prefers the submission of all test results and data points using CSV or
XML files. The submission must be carried out as specified in the
facility's approval. Paragraph (c)(2) allows the submission of test
results electronically using the Spirometry Results Notification form,
when specified under a facility's approval. Electronic submission of
test results via ePDF is acceptable when facilities are otherwise
unable to submit electronic files in CSV or XML format. These changes
are not substantive.
The final paragraph, concerning the confidentiality of test
results, is redesignated paragraph (d). The word ``examinations'' is
removed from the paragraph heading. The text in this paragraph is
revised to clarify that medical records containing protected health
information must be maintained pursuant to the requirements in Sec.
37.93(e). Finally, paragraph (d) is divided into two smaller paragraphs
for clarity. No public comment was received on this section.
Section 37.97 Notification of Spirometry Results
New Sec. 37.97, concerning the notification to miners or the
miner's designated physician of spirometry results, comprises text that
was located in Sec. 37.96(c). It is moved to a new section to make
information about notification procedures more accessible and to mirror
the structure of the subpart concerning chest radiographs. The original
text is revised slightly to clarify that a comparison between current
and previously submitted spirometry tests will be provided by NIOSH to
the miner if the results from more than one set of spirometry results
are available. One public commenter recommended that the results of
both radiography and spirometry be made available to a health
professional designated by the mine operator. NIOSH declines to adopt
this recommendation; a summary of the public comment and NIOSH's
response is located above, in the discussion concerning Sec. 37.54.
Section 37.98 Standards Incorporated by Reference
Existing Sec. 37.97, concerning standards incorporated by
reference into this subpart, is redesignated Sec. 37.98. Paragraph (a)
is revised to update the name of the NIOSH Respiratory Health Division,
as discussed above. The link to the ATS Standardization of Spirometry;
1994 Update, is updated, as is the link to the 2005 ATS/ERS
Standardisation of Spirometry. No comments were submitted on this
section.
C. Subpart--General Requirements
This subpart establishes general requirements for all surface and
underground coal mine operators.
Section 37.100 Coal Mine Operator Plan for Medical Examinations
Section 37.100 requires that all coal mine operators submit a plan
for providing miners with radiography and spirometry examinations.
Paragraph (a) requires operators to submit and receive NIOSH approval
for a plan to provide the examinations, as well as occupational
histories and respiratory assessments; it is unchanged. Paragraph
(a)(1) specifies that on or after August 1, 2014, a person becoming a
coal mine operator, for example by purchasing an existing mine or
developing a new mine, or a mine operator without an approved plan must
submit a plan within 60 days that provides for chest radiographs and
occupational histories. The paragraph is revised, inserting the word
``only,'' to clarify that the provision of spirometry tests need not be
included for a plan approved pursuant to this paragraph.
Paragraph (a)(2) states that all operators with approved
examination plans providing only for chest radiographs and occupational
histories will be notified by MSHA when they are required to submit an
amended plan that includes spirometry and respiratory assessments.
In paragraph (b), which lists the required components of the
operator's plan, the term ``X-ray'' is replaced with ``radiograph'' and
``tests'' are replaced with ``examinations'' in paragraph (b)(4);
``shall'' is replaced with ``must'' or ``will'' in paragraph (b)(5) in
accordance with the Federal Plain Language Guidelines.\10\
---------------------------------------------------------------------------
\10\ See Federal Plain Language Guidelines, https://www.plainlanguage.gov/howto/guidelines/FederalPLGuidelines/index.cfm.
---------------------------------------------------------------------------
Paragraph (c), which allows operators to provide for alternate
examination facilities, is revised to clarify that the alternate
facilities should be identified in the operator's plans submitted to
NIOSH for approval.
``Shall'' is also replaced by ``must'' and ``shall be'' is replaced
with ``is'' in paragraph (d), which states that an approved plan
remains in effect even when the mine operator has transferred
responsibility for the mine to a new operator.
Paragraph (e), concerning changes in mine plans, is unchanged.
Paragraph (f), which requires the display of a proposed plan or a
proposed change in plan, is revised slightly to clarify that only
changes to a NIOSH-approved plan need be displayed.
In paragraph (g), which requires that mine operators resubmit a
plan for each mine upon notification from NIOSH, the word ``will'' is
replaced with ``must'' in accordance with Federal Plain Language
Guidelines.
No public comment was received and no other changes are made to
this section.
Section 37.101 Approval of Plans
Section 37.101 establishes that the operator's plan will be
approved by NIOSH if it is found to meet the requirements in this
subpart. Paragraphs (a) and (b), concerning approval and denial of mine
operator plans, are unchanged. Paragraph (c) is revised to clarify that
NIOSH will inform MSHA if an operator's plan is denied, in addition to
the existing requirement for NIOSH to inform the operator. No comments
were submitted on this section.
Section 37.102 Transfer of Affected Miner to Less Dusty Area
Section 37.102 requires that any miner who has evidence of the
development of pneumoconiosis, as determined by NIOSH, must be given
the option of transferring to a less dusty area of the mine. A public
commenter recommended that transfer to a less dusty area should be
mandatory for all miners with ILO classifications greater than or equal
to category 2. According to the commenter, only 19 percent of over
3,000 miners who were offered an opportunity to transfer to a less
dusty area since 1980 have exercised that option. Thus, the commenter
thinks that the intervention program is ineffective ``in preventing
pulmonary function
[[Page 73278]]
loss,'' and that ``stronger measures must be put in place to increase
the participation in the transfer option.'' NIOSH cannot require
transfer of a miner who demonstrates evidence of development of
pneumoconiosis to a less dusty area. NIOSH concurs with MSHA's
position, as addressed in the agency's May 1, 2014 final rule, that a
mandatory transfer program would compromise the confidentiality of the
CWHSP. In addition, section 203 of the Mine Act (30 U.S.C. 843) only
speaks of optional transfers, and does not authorize mandatory
transfers. No additional public comment was received, and no changes
are made to the regulatory text.
Section 37.103 Medical Examinations at Miner's Expense
Section 37.103 states that any miner who wishes to obtain a
radiography examination or spirometry test at his or her own expense
may do so. For clarity, the word ``interpretation'' is replaced with
``evaluation of spirometry test results.'' No public comment was
received on this section.
General
One commenter asserted that NIOSH must take into account the
effects of cigarette smoking on the health outcomes of coal miners,
particularly chronic obstructive pulmonary disease (COPD). The
commenter referred to a 1995 NIOSH Criteria Document concerning
occupational exposure to respirable coal mine dust, which recommended
that underground and surface coal mine operators prohibit smoking in
all mines and other work areas associated with mining, provide
counseling to smokers about their increased risk of lung cancer and
COPD, and encourage them to participate in a smoking cessation
program.\11\
---------------------------------------------------------------------------
\11\ National Institute for Occupational Safety and Health, HHS,
Criteria for a Recommended Standard: Occupational Exposure to
Respirable Coal Mine Dust, DHHS (NIOSH) Publication No. 95-106,
September 1995, https://www.cdc.gov/niosh/docs/95-106/pdfs/95-106.pdf.
---------------------------------------------------------------------------
NIOSH acknowledges the effects of smoking and dust exposure on the
development of occupational respiratory disease. Accordingly, NIOSH
uses the Respiratory Assessment Form (CDC/NIOSH 2.13) in the course of
conducting a spirometry test; the form includes detailed questions
designed to establish the miner's smoking history.\12\ At the
population level, this data collection will allow NIOSH to take smoking
into account in evaluations of coal miners' respiratory health and will
assist NIOSH in developing interventions to benefit underground and
surface coal miners. At the level of the individual miner, the goal of
the radiography and spirometry conducted pursuant to part 37 is to
identify radiographic evidence of pneumoconiosis and spirometric
evidence of respiratory impairment, not to establish disease causation.
---------------------------------------------------------------------------
\12\ See Respiratory Assessment Form (CDC/NIOSH 2.13), questions
9, 9a, 9b, 9c, 9d, 10, 11, https://www.cdc.gov/niosh/topics/surveillance/pdfs/cwhsp-respiratoryassessment-2-13.pdf.
---------------------------------------------------------------------------
NIOSH lacks authority to prohibit smoking in underground and
surface coal mines, but includes information about health effects of
smoking in notifications to individual miners. Fortunately, many mines
prohibit smoking onsite.
IV. Regulatory Assessment Requirements
A. Executive Order 12866 and Executive Order 13563
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). E.O.
13563 emphasizes the importance of quantifying both costs and benefits,
of reducing costs, of harmonizing rules, and of promoting flexibility.
This final rule is not being treated as a ``significant'' action
under E.O. 12866. It finalizes and makes non-substantive revisions to
those sections in 42 CFR part 37 which added requirements for mine
operators to provide symptom assessment and spirometry testing for the
surveillance of decreased lung function to all coal miners, and
extended existing requirements to provide chest X-rays and occupational
histories for underground coal miners to surface coal mine operators.
The non-substantive revisions made in this final action to those
sections of 42 CFR part 37 that were promulgated by interim final rule
in August 2014 (79 FR 45110) will not result in costs to either the
agency or its stakeholders.
The rule does not interfere with State, local, or Tribal
governments in the exercise of their governmental functions.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq.,
requires each agency to consider the potential impact of its
regulations on small entities including small businesses, small
governmental units, and small not-for-profit organizations. This rule
establishes requirements for the provision of chest X-rays and
spirometry tests to all coal miners, and sets standards for the
approval of testing facilities and transmission of test data.
The potential impact on small businesses has been analyzed by MSHA,
in the Regulatory Economic Analysis published in support of that
agency's May 1, 2014 final rule (see https://www.msha.gov/REGS/REA/CoalMineDust2010.pdf). This final rule does not impose any new
requirements on small radiographic or spirometry facilities that
participate in the Coal Workers' Health Surveillance Program
administered by NIOSH under 42 CFR part 37. This final rule will not
impose a significant economic burden on small coal mines. Accordingly,
HHS certifies that this rule will not have a significant economic
impact on a substantial number of small entities within the meaning of
the RFA.
C. Paperwork Reduction Act
The Paperwork Reduction Act, 44 U.S.C. 3501 et seq., requires an
agency to invite public comment on, and to obtain OMB approval of, any
regulation that requires 10 or more people to report information to the
agency or to keep certain records. This final action continues to
impose the same information collection requirements as under the August
2014 IFR, including the submission of the following forms:
Consent, Release, and History Form for Autopsy [CDC/NIOSH
(M)2.6]
Chest Radiograph Classification Form [CDC/NIOSH 2.8]
Miner Identification Document [CDC/NIOSH 2.9]
Coal Mine Operator's Plan [CDC/NIOSH (M)2.10]
Radiographic Facility Certification Document [CDC/NIOSH
(M)2.11(E)]
Physician Application for Certification [CDC 2.12 (E)]
Respiratory Assessment Form [CDC/NIOSH 2.13]
Spirometry Facility Certification [CDC/NIOSH 2.14]
Spirometry Results Notification Form [CDC/NIOSH 2.15]
Coal Contractor Plan [CDC/NIOSH (M) 2.18 (E)]
These forms are approved by OMB for data collected under the
National Coal Workers' Health Surveillance Program (CWHSP) (OMB Control
No. 0920-0020, expires June 30, 2018). HHS estimates that the paperwork
burden associated with this rulemaking is 20,282 hours.
[[Page 73279]]
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondent Form name respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Coal Mine Operator............ 2.10............ 388 1 30/60 194
Coal Mine Contractor.......... 2.18............ 575 1 30/60 288
Radiograph Facility Supervisor 2.11............ 40 1 30/60 20
Coal Miner.................... 2.9............. 14,560 1 20/60 4,854
Coal Miner--Radiograph........ No form required 14,560 1 15/60 3,640
B Reader Physician............ 2.8............. 10 3014 3/60 1,507
Physicians taking the B Reader 2.12............ 100 1 10/60 17
Examination.
Spirometry Facility Supervisor 2.14............ 100 1 30/60 50
Spirometry Facility Employee.. 2.13............ 14,560 1 5/60 1,214
Spirometry Technician......... 2.15............ 14,560 1 20/60 4,854
Coal Mine--Spirometry......... No form required 14,560 1 15/60 3,640
Pathologist................... Invoice--No 5 1 5/60 1
standard form.
Pathologist................... Pathology 5 1 5/60 1
Report--No
standard form.
Next-of-kin for deceased miner 2.6............. 5 1 15/60 2
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 20,282
----------------------------------------------------------------------------------------------------------------
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 classifications that
result in a finding of pneumoconiosis may be an element in claim
processing and adjudication conducted by DOL's Black Lung Compensation
Program. This final action affects radiographs submitted to DOL for the
purpose of reviewing and administering those claims. This rule has been
reviewed carefully to eliminate drafting errors and ambiguities.
G. Executive Order 13132 (Federalism)
The Department has reviewed this rule in accordance with Executive
Order 13132 regarding federalism, and has determined that it does not
have ``federalism implications.'' The rule does not ``have substantial
direct effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
H. Executive Order 13045 (Protection of Children From Environmental
Health Risks and Safety Risks)
In accordance with Executive Order 13045, HHS has evaluated the
environmental health and safety effects of this rule on children. HHS
has determined that the rule would have no effect on children.
I. Executive Order 13211 (Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use)
In accordance with Executive Order 13211, HHS has evaluated the
effects of this rule on energy supply, distribution or use, and has
determined that the rule will not have a significant adverse effect.
J. Plain Writing Act of 2010
Under Public Law 111-274 (October 13, 2010), executive Departments
and Agencies are required to use plain language in documents that
explain to the public how to comply with a requirement the Federal
government administers or enforces. HHS has attempted to use plain
language in drafting this final action consistent with the Federal
Plain Writing Act guidelines.
List of Subjects in 42 CFR Part 37
Chronic obstructive pulmonary disease, Coal workers'
pneumoconiosis, Incorporation by reference, Lung diseases, Mine safety
and health, Occupational safety and health, Pneumoconiosis, Respiratory
and pulmonary diseases, Silicosis, Spirometry, Surface coal mining,
Transfer rights, Underground coal mining, X-rays.
Text of the Rule
For the reasons discussed in the preamble, the Department of Health
and Human Services amends 42 CFR part 37 as follows:
PART 37--SPECIFICATIONS FOR MEDICAL EXAMINATIONS OF COAL MINERS
0
1. The authority citation for part 37 continues to read as follows:
Authority: Sec. 203, 83 Stat. 763 (30 U.S.C. 843), unless
otherwise noted.
0
2. Amend Sec. 37.2 by revising the introductory text and the
definitions of ``Act'', ``Convenient time and place'', ``Digital
radiography systems'', ``ILO Classification'', ``NIOSH'', ``Panel of B
Readers'', and ``Radiologic technologist'' and by adding definitions of
``B Reader'' and ``Facility'' to read as follows:
Sec. 37.2 Definitions.
Any term defined in the Federal Mine Safety and Health Act of 1977
(30 U.S.C. 801 et seq., Pub. L. 95-164, as amended) and not defined
below will have the meaning given it in the Act. As used in this
subpart:
[[Page 73280]]
Act means the Federal Mine Safety and Health Act of 1977 (30 U.S.C.
801, et seq., Pub. L. 95-164, as amended).
B Reader means a physician certified by NIOSH as able to classify
chest radiographs using the ILO Classification system, pursuant to
Sec. 37.52(b).
* * * * *
Convenient time and place means that an examination conducted
pursuant to this part must be given at a reasonable hour in the
locality in which the miner resides or a location that is equally
accessible to the miner. For example, examinations at the mine during,
immediately preceding, or immediately following work and a ``no
appointment'' examination at a medical facility in a community easily
accessible to the residences of a majority of the miners working at the
mine will be considered of equivalent convenience for purposes of this
definition.
Digital radiography systems, as used in this context, include both
Digital Radiography (DR) and Computed Radiography (CR) systems.
(1) Computed radiography (CR) is the term for digital radiographic
image acquisition systems that detect radiographic 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
radiographic image acquisition systems in which the radiographic
signals received by the image detector are converted nearly
instantaneously to electronic signals without movable cassettes.
Facility means a facility or organization licensed to provide
health care by the State or Territory in which services are provided,
such as a hospital, a clinic, or other provider that performs medical
examinations.
ILO Classification means the classification of radiographs using
the International Classification of Radiographs of Pneumoconioses, a
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 approved by NIOSH as equivalent. The ILO
Classification is incorporated by reference into Sec. Sec. 37.50(a)
and (c) and 37.51(b).
* * * * *
NIOSH means the National Institute for Occupational Safety and
Health (NIOSH), located within the Centers for Disease Control and
Prevention (CDC). Within NIOSH, the Respiratory Health Division (RHD),
1095 Willowdale Road, Morgantown, WV 26505, is the organizational unit
that has programmatic responsibility for the Coal Workers' Health
Surveillance Program.
* * * * *
Panel of B Readers means the group of physicians that are currently
certified by NIOSH as B Readers and who classify or otherwise evaluate
radiographs for the Coal Workers' Health Surveillance Program.
* * * * *
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 radiographs as specified by the
State or Territory and examining facility in which such services are
provided. Optimally, such an individual will have completed a formal
training program in radiography leading to a certificate, an associate
degree, or a bachelor's degree and participated in the voluntary
initial certification and annual renewal of registration for radiologic
technologists offered by the American Registry of Radiologic
Technologists.
* * * * *
0
3. Revise Sec. 37.3 to read as follows:
Sec. 37.3 Chest radiographs required for miners.
(a) Voluntary examinations. Every operator must provide to each
miner who is employed in or at any of its coal mines and who was
employed in coal mining prior to December 30, 1969, or who has
completed the required examinations under paragraph (b) of this section
an opportunity for a chest radiograph at no cost to the miner in
accordance with this subpart:
(1) NIOSH will notify the operator of each coal mine of a period
within which the operator may provide examinations to each miner
employed at its coal mine. The period must begin no sooner than 3.5
years and end no later than 4.5 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 for each mine, the
operator may select a 6-month period within which to provide
examinations in accordance with a plan approved under Sec. 37.101.
(2) Within either the next or future period(s) specified to the
operator for each of its coal mines, the operator of the coal mine may
select a different 6-month period for each of its mines within which to
offer examinations. In the event the operator does not submit an
approved plan, NIOSH will specify a 6-month period to the operator
within which miners must have the opportunity for examinations.
(b) Mandatory examinations. Every operator must provide to each
miner who begins working in or at an underground coal mine for the
first time after December 30, 1969 or in or at a surface coal mine for
the first time after August 1, 2014:
(1) An initial chest radiograph, as soon as possible, but in no
event later than 30 days after commencement of employment or within 30
days of approval of a plan to provide chest radiographs. An initial
chest radiograph given to a miner according to former regulations for
this subpart prior to August 1, 2014 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 coal mining. A second radiograph given to a miner according to
former regulations under this subpart prior to August 1, 2014 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 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
pneumoconiosis, or complicated pneumoconiosis (ILO Classification) or
if the second spirometry examination specified in Sec. 37.92(b)(2)
shows evidence of decreased lung function to the extent specified in
Sec. 37.92(b)(3).
(c) Notification. NIOSH will notify the miner when he or she is due
to receive the second or third mandatory examination under paragraph
(b) of this section. NIOSH will notify the coal mine operator when the
miner is to be given a second examination.
(1) The operator will be notified of a miner's third examination
only with the miner's written consent. The notice to the operator will
not state the medical reason for the examination or that it is the
third examination in the series.
(2) 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 NIOSH-approved operator's plan
will constitute the operator's compliance with the requirement to
provide a third
[[Page 73281]]
mandatory examination even if the miner refuses to take the
examination.
(d) Availability of chest radiographs. The opportunity for chest
radiographs to be made available by an operator for purposes of this
subpart must be provided in accordance with a plan that has been
submitted and approved in accordance with this part.
0
4. Revise Sec. 37.4 to read as follows:
Sec. 37.4 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:
(1) Where, in the judgment of the Secretary, due to the lack of
adequate medical or other necessary facilities or personnel at the mine
or in the locality where the miner resides, the required radiographic
examination cannot be given.
(2) Where the operator has not submitted an approvable plan.
(3) Where, after commencement of an operator's program pursuant to
an approved plan and after notice to the operator of his failure to
follow the approved plan and, after allowing 15 calendar days to bring
the program into compliance, the Secretary determines and notifies the
operator in writing that the operator's program still fails to comply
with the approved plan.
(b) The operator of the mine must reimburse the Secretary or other
person, agency, or institution as the Secretary may direct, for the
cost of conducting each examination made in accordance with this
section.
(c) All examinations given or arranged by the Secretary will comply
with the time requirements of Sec. 37.3. Whenever the Secretary gives
or arranges for the examinations of miners at a time, a written notice
of the arrangements will be sent to the operator who must post the
notice on the mine bulletin board.
0
5. Revise Sec. 37.10 to read as follows:
Sec. 37.10 Standards incorporated by reference.
(a) Certain material is incorporated by reference into this
subpart, Subpart--Chest Radiographic Examinations, with the approval of
the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR
part 51. To enforce any edition other than that specified in this
section, NIOSH must publish notice of change in the Federal Register
and the material must be available to the public. All approved material
is available for inspection at NIOSH, Respiratory Health Division, 1095
Willowdale Road, Morgantown, WV 26505. To arrange for an inspection at
NIOSH, call 304-285-5749. Copies are also available for inspection at
the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030 or go to https://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(b) American Association of Physicists in Medicine, Order
Department, Medical Physics Publishing, 4513 Vernon Blvd., Madison, WI
53705, https://www.aapm.org/pubs/reports:
(1) AAPM On-Line Report No. 03, Assessment of Display Performance
for Medical Imaging Systems, April 2005, into Sec. 37.51(d) and (e).
(2) AAPM Report No. 14, Performance Specifications and Acceptance
Testing for X-Ray Generators and Automatic Exposure Control Devices,
Report of the Diagnostic X-Ray Imaging Committee Task Group on
Performance Specifications and Acceptance Testing for X-Ray Generators
and Automatic Exposure Control Devices, published by the American
Institute of Physics for AAPM, January 1985, into Sec. Sec. 37.42(h)
and 37.44(g).
(3) AAPM Report No. 31, Standardized Methods for Measuring
Diagnostic X-Ray Exposures, Report of Task Group 8, Diagnostic X-Ray
Imaging Committee, published by the American Institute of Physics, July
1990, into Sec. 37.44(g).
(4) AAPM Report No. 74, Quality Control in Diagnostic Radiology,
Report of Task Group 12, Diagnostic X-Ray Imaging Committee, published
by Medical Physics Publishing for AAPM, July 2002, into Sec. Sec.
37.42(h), 37.43(f), and 37.44(g).
(5) AAPM Report No. 93, Acceptance Testing and Quality Control of
Photostimulable Storage Phosphor Imaging Systems, October 2006, into
Sec. Sec. 37.42(i) and 37.44(g).
(6) AAPM Report No. 116, An Exposure Indicator for Digital
Radiography, Report of AAPM Task Group 116, published by AAPM, July
2009, into Sec. 37.44(g).
(c) American College of Radiology, 1891 Preston White Dr., Reston,
VA 20191, https://www.acr.org:
(1) ACR Practice Guideline for Diagnostic Reference Levels in
Medical X-Ray Imaging, Revised 2008 (Resolution 3), into Sec. Sec.
37.42(i) and 37.44(g).
(2) [Reserved]
(d) International Labour Office, CH-1211 Geneva 22, Switzerland,
https://www.ilo.org/publns:
(1) Guidelines for the Use of the ILO International Classification
of Radiographs of Pneumoconioses, Revised Edition 2011, into Sec. Sec.
37.50(a), 37.50(c), and 37.51(b).
(2) [Reserved]
(e) National Council on Radiation Protection and Measurements, NCRP
Publications, 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3095,
Telephone (800) 229-2652, https://www.ncrppublications.org:
(1) NCRP Report No. 102, Medical X-ray, Electron Beam, and Gamma-
Ray Protection for Energies Up to 50 MeV (Equipment Design,
Performance, and Use), issued June 30, 1989, into Sec. [thinsp]37.45.
(2) NCRP Report No. 105, Radiation Protection for Medical and
Allied Health Personnel, issued October 30, 1989, into Sec.
[thinsp]37.45.
(3) NCRP Report No. 147, Structural Shielding Design for Medical X-
Ray Imaging Facilities, revised March 18, 2005, into Sec.
[thinsp]37.45.
(f) National Electrical Manufacturers Association, 1300 N. 17th
Street, Rosslyn, VA 22209, https://medical.nema.org:
(1) DICOM Standard PS 3.3-2011, Digital Imaging and Communications
in Medicine (DICOM) standard, Part 3: Information Object Definitions,
copyright 2011, into Sec. 37.42(i).
(2) DICOM Standard PS3.4-2011, Digital Imaging and Communications
in Medicine (DICOM) standard, Part 4: Service Class Specifications,
copyright 2011, into Sec. 37.42(i).
(3) DICOM Standard PS 3.10-2011, Digital Imaging and Communications
in Medicine (DICOM) standard, Part 10: Media Storage and File Format
for Media Interchange, copyright 2011, into Sec. 37.42(i).
(4) DICOM Standard PS 3.11-2011, Digital Imaging and Communications
in Medicine (DICOM) standard, Part 11: Media Storage Application
Profiles, copyright 2011, into Sec. 37.42(i).
(5) DICOM Standard PS 3.12-2011, Digital Imaging and Communications
in Medicine (DICOM) standard, Part 12: Media Formats and Physical Media
for Media Interchange, copyright 2011, into Sec. Sec. 37.42(i) and
37.44(a).
(6) DICOM Standard PS 3.14-2011, Digital Imaging and Communications
in Medicine (DICOM) standard, Part 14: Grayscale Standard Display
Function, copyright 2011, into Sec. Sec. 37.42(i)(5) and 37.51(d).
(7) DICOM Standard PS 3.16-2011, Digital Imaging and Communications
in Medicine (DICOM) standard, Part 16:
[[Page 73282]]
Content Mapping Resource, copyright 2011, into Sec. 37.42(i).
0
6. Revise Sec. 37.20 to read as follows:
Sec. 37.20 Miner identification document.
As part of the examination, a Miner Identification Document (CDC/
NIOSH (M)2.9) which includes an occupational history questionnaire must
be completed for each miner at the facility where the examination is
made (this document is required for both radiographic and spirometry
examinations conducted pursuant to this part).
0
7. Revise Sec. 37.40 to read as follows:
Sec. 37.40 General provisions.
(a) The chest radiographic examination must be given at a
convenient time and place.
(b) The chest radiographic examination consists of the chest
radiograph, a completed Chest Radiograph Classification Form (CDC/NIOSH
2.8), and a completed Miner Identification Document (CDC/NIOSH 2.9).
(c) A radiographic examination must be made in a facility approved
in accordance with Sec. 37.43 or Sec. 37.44. Chest radiographs of
miners under this section must be performed:
(1) By or under the supervision of a physician who makes chest
radiographs in the normal course of practice and who has demonstrated
ability to make chest radiographs of a quality to best ascertain the
presence of pneumoconiosis; or
(2) By a radiologic technologist as defined in Sec. 37.2.
0
8. Revise Sec. 37.43 to read as follows:
Sec. 37.43 Approval of radiographic facilities that use film
radiography systems.
(a) Facilities become eligible to participate in this program by
demonstrating their ability to make high quality diagnostic chest
radiographs by submitting to NIOSH six or more sample chest radiographs
made and processed at the applicant facility and which are of
acceptable quality to one or more individuals selected by NIOSH from
the panel of B Readers. Applicants must also submit a radiograph of a
plastic step-wedge object \1\ or other test object (available on loan
from NIOSH) that was made and processed at the same time with the same
technique as the radiographs submitted and processed at the facility
for which approval is sought.
---------------------------------------------------------------------------
\1\ The plastic step-wedge object is described in E. Dale Trout,
John P. Kelley, A Phantom for the Evaluation of Techniques and
Equipment Used for Roentgenography of the Chest, Amer J Roentgenol
1973;117(4):771-776.
---------------------------------------------------------------------------
(1) At least one chest radiograph and one test object radiograph
must have been made with each unit to be used hereunder.
(2) All radiographs must have been made within 15 calendar days
prior to submission and must be marked to identify the facility where
each radiograph was made, the X-ray machine used, and the date each was
made.
(3) The chest radiographs will be returned and may be the same
radiographs submitted pursuant to Sec. 37.52(a)(2)(i).
(b) Each radiographic facility submitting chest radiographs for
approval under this section must complete and include a Radiographic
Facility Certification Document (CDC 2.11) describing each unit to be
used to make chest radiographs under the Act. The form must include:
(1) The date of the last radiation safety inspection by an
appropriate licensing agency or, if no such agency exists, by a
qualified expert as defined in NCRP Report No. 102 (incorporated by
reference, see Sec. 37.10);
(2) The deficiencies found;
(3) A statement that all the deficiencies have been corrected; and
(4) The date of acquisition of the unit. To be acceptable, the
radiation safety inspection must have been made within 1 year preceding
the date of application.
(c) Radiographs submitted with applications for approval under this
section will be evaluated by one or more individuals selected by NIOSH
from the panel of B Readers or by a qualified medical physicist or
consultant. Applicants will be advised of any reasons for denial of
approval.
(d) NIOSH or its representatives may make a physical inspection of
the applicant's facility and any approved radiographic facility at any
reasonable time to determine if the requirements of this subpart are
being met.
(e) NIOSH may require a facility periodically to resubmit
radiographs of a test object, sample radiographs, or a Radiographic
Facility Certification Document for quality control purposes.
(1) 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.
(2) A copy of a notice withdrawing approval will be sent to each
operator who has listed the facility as its facility for giving chest
radiographs and must be displayed on the mine bulletin board adjacent
to the operator's approved plan. The approved plan will be reevaluated
by NIOSH in light of this change.
(f) A formal written quality assurance program must be established
at each facility addressing radiation exposures, equipment maintenance,
and image quality, and must conform to the standards in AAPM Report No.
74, pages 1-19, 47-53, and 56 (incorporated by reference, see Sec.
37.10).
(g) In conducting medical examinations pursuant to this part,
physicians and radiographic facilities must maintain the results and
analysis of these examinations (including any hard copies or digital
files containing individual data, classifications, and images)
consistent with applicable statutes and regulations governing the
handling and protection of individually identifiable health
information, including, as applicable, the HIPAA Privacy and Security
Rules (45 CFR part 160 and 45 CFR part 164, subparts A, C, and E).
0
9. Revise Sec. 37.44 to read as follows:
Sec. 37.44 Approval of radiographic facilities that use digital
radiography systems.
(a) Facilities seeking approval must demonstrate the ability to
make high quality digital chest radiographs by submitting to NIOSH
digital radiographic image files of a test object (e.g., a plastic
step-wedge or chest phantom which will be provided on loan from NIOSH)
as well as digital radiographic image files from six or more sample
chest radiographs that are of acceptable quality to one or more
individuals selected by NIOSH from the panel of B Readers and a
qualified medical physicist or consultant, both designated by NIOSH.
(1) Image files must be submitted on standard portable media
(compact or digital video disc) and formatted to meet specifications of
the Digital Imaging and Communications in Medicine (DICOM) standard PS
3.12-2011 (incorporated by reference, see Sec. 37.10). Applicants will
be advised of any reasons for denial of approval.
(2) All submitted images must be made within 60 days prior to the
date of application using the same technique, equipment, and software
as will be used by the facility under the requested approval. At least
six chest radiographs and one test object radiograph must have been
made with each digital radiographic unit to be used by the facility
under the requested approval. The corresponding radiographic image
files must be submitted on standard portable media (compact or digital
video disc) and formatted to meet specifications of the current DICOM
Standard PS 3.12-2011.
[[Page 73283]]
(3) Documentation must include the following: the identity of the
facility where each radiograph was made; the X-ray machine used; and
the model, version, and production date of each image acquisition
software program and hardware component.
(4) The submitted sample digital chest image files must include at
least two taken with the detector in the vertical position and two in
the horizontal position where the imaging system permits these
positions, and at least two chest images must be from persons within
the highest quartile of chest diameters (28 cm or greater).
(b) Each radiographic facility submitting chest radiographic image
files for approval under this section must complete and include an
Radiographic Facility Certification Document (CDC 2.11) describing each
system component, and the models and versions of image acquisition
hardware and software to be used to make digital chest radiographs
under the Act. The form must include:
(1) A copy of a dated report signed by a qualified medical
physicist, documenting the evaluation of radiation safety and
performance characteristics specified in this section for each digital
radiography system;
(2) A copy of the report of the most recent radiation safety
inspection by a licensing agency, if such agency exists;
(3) A listing of all deficiencies noted in either of the reports;
(4) A statement that all the listed deficiencies have been
corrected; and
(5) The names and relevant training and experience of facility
personnel described in paragraphs (c), (e), and (f) of this section. To
be acceptable, the report by the medical physicist and radiation safety
inspection specified in this paragraph (b) must have been made within 1
year prior to the date of submission of the application.
(c) Facilities must maintain ongoing licensure and certification
under relevant local, State, and Federal laws and regulations for all
digital equipment and related processes covered under this part.
(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 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 Radiographic Facility
Certification Document. Approvals granted to facilities under this
section may be suspended or withdrawn by notice in writing when, in the
opinion of NIOSH, deficiencies in the quality of radiographs or
information submitted under this section warrant such action. A copy of
a notice suspending or withdrawing approval will be sent to each
operator that has listed the facility for its use under this part and
must be displayed on the mine bulletin board adjacent to the operator's
approved plan. The operator's approved plan may be reevaluated by NIOSH
in response to such suspension or withdrawal.
(f) A qualified medical physicist who is familiar with the facility
hardware and software systems for image acquisition, manipulation,
display, and storage, must be on site or available as a consultant. The
physicist must be trained in evaluating the performance of radiographic
equipment and facility quality assurance programs, and must be
licensed/approved by a State or Territory of the United States or
certified by a competent U.S. national board.
(g) Facilities must document that testing performed by a qualified
medical physicist has verified that performance of each image
acquisition system for which approval is sought met initial
specifications and standards of the equipment manufacturer and
performance testing as required under paragraphs (c), (f), and (h) of
this section.
(h) A formal written quality assurance program must be established
at each facility addressing radiation exposures, equipment maintenance,
and image quality, and must conform to the standards in AAPM Report No.
74, pages 1-19, 47-53, and 56, and AAPM Report No. 116, sections VIII,
IX, and X (incorporated by reference, see Sec. 37.10).
(1) Applications for facility approval must include a comprehensive
assessment by a qualified medical physicist within 12 months prior to
application addressing the performance of X-ray generators, automatic
exposure controls, and image capture systems. The assessment must
comply with the following guidelines: AAPM Report No. 93, pages 1-68;
AAPM Report No. 74, pages 6-11; and AAPM Report No. 14, pages 1-96
(incorporated by reference, see Sec. 37.10).
(2) Radiographic technique charts must be used that are developed
specifically for the radiography system and detector combinations used,
indicating exposure parameters by anatomic measurements. If automated
exposure control devices are used, calibration for chest imaging must
be documented using the actual voltages and image capture systems.
(i) Radiological exposures resulting from at least ten (randomly
selected) digital chest images obtained at the facility must be
monitored at least quarterly to detect and correct potential dose
creep, using methods specified in AAPM Report No. 31 (incorporated by
reference, see Sec. 37.10). Radiation exposures must be compared to a
professionally accepted reference level published in the American
College of Radiology (ACR) Practice Guideline for Diagnostic Reference
Levels in Medical X-Ray Imaging, pages 1-6 (incorporated by reference,
see Sec. 37.10).
(ii) The medical physicist must conduct an annual assessment of
measured or estimated radiation exposures, with specific recommended
actions to minimize exposures during examinations performed under this
part.
(3) For each digital radiography device and system, performance
must be monitored annually in accordance with the recommendations of
AAPM Report No. 93 (incorporated by reference, see Sec. 37.10), except
for the testing specifically excluded below. Documentation must be
maintained on the completion of quality assurance testing, including
the reproducibility of X-ray output, linearity and reproducibility of
mA settings, accuracy and reproducibility of timer and kVp settings,
accuracy of source-to-detector distance, and X-ray field focal spot
size, selection, beam quality, congruence and collimation. For DR
systems, the following tests listed in AAPM Report No. 93 are not
required under this part:
(i) Section 8.4.5: Laser beam function.
(ii) Section 8.4.9: Erasure Thoroughness.
(iii) Section 8.4.11: Imaging Plate (IP) Throughput.
(4) Facilities must maintain documentation, available for
inspection by NIOSH for 5 years, of the ongoing implementation of
policies and procedures for monitoring and evaluating the effective
management, safety, and proper performance of chest image acquisition,
digitization, processing, compression, transmission, display,
archiving, and retrieval functions of digital radiography devices and
systems.
(i) In conducting medical examinations pursuant to this part,
physicians and radiographic facilities must maintain the results and
analysis of these examinations (including any hard copies or digital
files containing individual data, interpretations, and images)
consistent with applicable statutes and regulations governing the
handling and protection of individually identifiable health
information, including, as applicable, the HIPAA
[[Page 73284]]
Privacy and Security Rules (45 CFR part 160 and 45 CFR part 164,
subparts A, C, and E).
0
10. Revise Sec. 37.50 to read as follows:
Sec. 37.50 Interpreting and classifying chest radiographs--film
radiography systems.
(a) Chest radiographs must be interpreted and classified in
accordance with the Guidelines for the Use of the ILO International
Classification of Radiographs of Pneumoconioses (incorporated by
reference, see Sec. 37.10). Chest radiograph interpretations and
classifications must be recorded on a paper or electronic Chest
Radiograph Classification Form (CDC/NIOSH 2.8).
(b) Radiographs must be interpreted and classified only by a
physician who reads chest radiographs in the normal course of practice
and who has demonstrated proficiency in classifying the pneumoconioses
in accordance with Sec. 37.52.
(1) Initial clinical interpretations and notification of findings
other than pneumoconiosis under paragraph (a) of this section must be
provided by a qualified physician who provides these services for the
examining facility. This physician must have all required licensure and
privileges, and must interpret chest radiographs in the normal course
of practice.
(2) [Reserved]
(c) All interpreters, whenever interpreting chest radiographs made
under the Act, must have immediately available for reference a complete
set of the standard radiographs for use with the Guidelines for the Use
of the ILO International Classification of Radiographs of
Pneumoconioses (incorporated by reference, see Sec. 37.10).
(d) View boxes used for making interpretations must comply with the
following:
(1) Fluorescent lamps must be simultaneously replaced with new
lamps at 6-month intervals;
(2) All the fluorescent lamps in a panel of boxes must have
identical manufacturer's ratings as to intensity and color;
(3) The glass, internal reflective surfaces, and the lamps must be
kept clean;
(4) The unit must be so situated as to minimize front surface
glare.
0
11. Revise Sec. 37.51 to read as follows:
Sec. 37.51 Interpreting and classifying chest radiographs--digital
radiography systems.
(a) For each chest radiograph obtained at an approved facility
using a digital radiography system, a qualified and licensed physician
who reads chest radiographs in the normal course of practice must
provide an initial clinical interpretation and notification, as
specified in Sec. 37.54, of any significant abnormal findings other
than pneumoconiosis.
(b) Chest radiographs must be classified for pneumoconiosis by
physician readers (B Readers) who have demonstrated ongoing
proficiency, as specified in Sec. 37.52(b), in classifying the
pneumoconioses in a manner consistent with the Guidelines for the Use
of the ILO International Classification of Radiographs of
Pneumoconioses (incorporated by reference, see Sec. 37.10). Chest
radiograph classifications must be recorded on a paper or electronic
Chest Radiograph Classification Form (CDC/NIOSH 2.8).
(c) All B Readers, whenever classifying digitally-acquired chest
radiographs made under the Act, must have immediately available for
reference a complete set of NIOSH-approved standard digital chest
radiographic images, including electronic images such as scanned
images, provided for use with the Guidelines for the Use of the ILO
International Classification of Radiographs of Pneumoconioses
(incorporated by reference, see Sec. 37.10).
(1) Only NIOSH-approved standard digital (electronic) images may be
used for classifying digital chest images for pneumoconiosis.
(2) Modification of the appearance of the standard images using
software tools is not permitted.
(d) Viewing systems should enable readers to display the coal
miner's chest image at the full resolution of the image acquisition
system, side-by-side with the selected NIOSH-approved standard images
for comparison.
(1)(i) Image display devices must be flat panel monitors displaying
at least 3 MP at 10 bit depth. Image displays and associated graphics
cards must meet the calibration and other specifications of the Digital
Imaging and Communications in Medicine (DICOM) standard PS 3.14-2011
(incorporated by reference, see Sec. 37.10).
(ii) Image displays and associated graphics cards must not deviate
by more than 10 percent from the grayscale standard display function
(GSDF) when assessed according to the AAPM On-Line Report No. 03, pages
1-146 (incorporated by reference, see Sec. 37.10).
(2) Display system luminance (maximum and ratio), relative noise,
linearity, modulation transfer function (MTF), frequency, and glare
should meet or exceed recommendations listed in AAPM On-Line Report No.
03, pages 1-146 (incorporated by reference, see Sec. 37.10). Viewing
displays must have a maximum luminance of at least 171 cd/m2, a ratio
of maximum luminance to minimum luminance of at least 250, and a glare
ratio greater than 400. The contribution of ambient light reflected
from the display surface, after light sources have been minimized, must
be included in luminance measurements.
(3) Displays must be situated so as to minimize front surface
glare. Readers must minimize reflected light from ambient sources
during the performance of classifications.
(4) Measurements of the width and length of pleural shadows and the
diameter of opacities must be taken using calibrated software measuring
tools. If permitted by the viewing software, a record must be made of
the presentation state(s), including any noise reduction and edge
enhancement or restoration functions that were used in performing the
classification, including any annotations and measurements.
(e) Quality control procedures for devices used to display chest
images for classification must comply with the recommendations of the
American Association of Physicists in Medicine AAPM On-Line Report No.
03, pages 1-146 (incorporated by reference, see Sec. 37.10).
(1) If automatic quality assurance systems are used, visual
inspection must be performed using one or more test patterns
recommended by the medical physicist every 6 months, or more
frequently, to check for defects that automatic systems may not detect.
(2) [Reserved]
(f) Classification of CR and DR digitally-acquired chest
radiographs under this part must be performed based on the viewing of
images displayed as soft copies using the viewing workstations
specified in this section. Classification of radiographs must not be
based on the viewing of hard copy printed transparencies of images that
were digitally-acquired.
(g) The classification of chest radiographs based on digitized
copies of chest radiographs that were originally acquired using film-
screen techniques is not permissible under this part.
0
12. Revise 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 of a physician as an A Reader continues indefinitely
if established prior to October 15, 2012.
(2) Physicians who desire to become 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
[[Page 73285]]
properly classified by one or more individuals selected by NIOSH from
the panel of B Readers. The six radiographs must consist of two without
pneumoconiosis, two with simple pneumoconiosis, and two with
complicated pneumoconiosis (these may be the same radiographs submitted
for facility approval pursuant to Sec. Sec. 37.43 and 37.44). The
films will be returned to the physician. The classifications must be on
the Chest Radiograph Classification Form (CDC/NIOSH 2.8); or
(ii) Satisfactory completion, since June 11, 1970, of a course
approved by NIOSH on the ILO International Classification of
Radiographs of Pneumoconioses.
(b) Final or B Readers:
(1) Approval as a B Reader established prior to October 1, 1976, is
hereby terminated.
(2) Proficiency in evaluating chest radiographs for radiographic
quality and in the use of the ILO Classification for interpreting chest
radiographs for pneumoconiosis and other diseases must be demonstrated
by those physicians who desire to be B Readers by taking and passing a
specially-designed proficiency examination given on behalf of or by
NIOSH at a time and place specified by NIOSH.
(i) 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.
(ii) Physicians who qualify under this provision need not be
qualified under paragraph (a) of this section.
(c) Physicians who wish to participate in the program must
familiarize themselves with the necessary components for attainment of
reliable classification of chest radiographs for the pneumoconioses\2\
and apply using a Physician Application for Certification Form (CDC
2.12(E)).
---------------------------------------------------------------------------
\2\ NIOSH Safety and Health Topic, Chest Radiography:
Radiographic Classification, https://www.cdc.gov/niosh/topics/chestradiography/radiographic-classification.html.
0
13. Revise Sec. 37.53 to read as follows:
Sec. 37.53 Method of obtaining definitive chest radiograph
classifications.
(a) All chest radiographs which are first classified by an A or B
Reader will be submitted by NIOSH to a B Reader qualified pursuant to
Sec. 37.52.
(1) If there is agreement between the two classifications, as
described in paragraph (b) of this section, the result will be
considered final and reported to MSHA for transmittal to the miner.
(2) When agreement is lacking, NIOSH must obtain a third
classification from the panel of B Readers.
(i) If any two of the three classifications demonstrate agreement,
the result must be considered the final determination.
(ii) If agreement is lacking among the three classifications, 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 classifications are considered to be in agreement when:
(1) They are derived from complete classifications recorded using
approved paper or electronic versions of the Chest Radiograph
Classification Form (CDC/NIOSH 2.8) and received by NIOSH; and
(2) Both find either stage A, B, or C complicated pneumoconiosis;
or,
(3) For simple pneumoconiosis, are both in the same major category
or are within one minor category (ILO Classification 12-point scale) of
each other (subject to the exception in paragraph (b)(3)(ii) of this
section).
(i) The higher of the two classifications must be reported.
(ii) The only exception to the one minor category principle is a
reading sequence of 0[sol]1, 1[sol]0 or 1[sol]0, 0[sol]1, which are not
considered agreement.
0
14. Revise Sec. 37.54 to read as follows:
Sec. 37.54 Notification of abnormal radiographic findings.
(a) Significant abnormal findings other than pneumoconiosis. The
first physician to interpret the radiograph must communicate findings
of, or findings suggesting, abnormality of cardiac shape or size,
tuberculosis, lung cancer, or any other significant abnormal findings
other than pneumoconiosis to the miner indicated on the Miner
Identification Document or to the miner's designated physician. A
notice of the communication must be submitted to NIOSH. When
significant abnormal findings are reported, NIOSH will also notify the
miner to contact his or her physician.
(b) Significant changes or progression of disease. When NIOSH has
more than one radiograph of a miner in its files and the most recent
examination was found by the first physician to interpret the
radiograph or subsequently by NIOSH B Readers to show an abnormality of
cardiac shape or size, tuberculosis, cancer, complicated
pneumoconiosis, and any other significant abnormal findings, NIOSH will
arrange for a licensed physician to compare the most recent image to
older images and NIOSH will inform the miner of any significant changes
or progression of disease or other findings.
(c) Notice of eligibility for part 90 transfer option. All final
determinations of radiographic classifications providing evidence for
development of pneumoconiosis will be reported to the miner or to the
miner's designated physician by NIOSH. In addition, NIOSH will
coordinate with MSHA to assure that such miners are notified of
eligibility to transfer to a less dusty area, in accordance with
section 203 of the Act (see 30 CFR part 90 and Sec. 37.102).
(d) Prompt dispatch of findings. 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.
(1) NIOSH will coordinate with MSHA to provide notice of
eligibility for the part 90 transfer option within the same time frame.
(2) The results of an examination may not be processed by NIOSH if
the examination was made within 6 months of the date of a previous
acceptable examination.
0
15. Revise Sec. 37.60 to read as follows:
Sec. 37.60 Submitting required chest radiograph classification and
miner identification documents.
(a) Each chest radiograph required to be made under this subpart,
together with the completed Chest Radiograph Classification Form and
the completed Miner Identification Document, must be submitted together
for each miner to NIOSH within 14 calendar days after the radiographic
examination is given. All submitted items 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 Chest Radiograph Classification Form and the completed
Miner Identification Document, must be submitted to NIOSH using the
software and format specified by NIOSH either using portable electronic
media, or a secure electronic file transfer.
(2) 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.
(b) If NIOSH deems any submission under paragraph (a) of this
section inadequate, the operator will be notified of the deficiency.
The operator must
[[Page 73286]]
promptly make appropriate arrangements for the necessary reexamination
at no expense to the miner.
(c) Failure to comply with paragraph (a) or (b) of this section
will be cause to revoke approval of a plan or any other approval as may
be appropriate. An approval that has been revoked may be reinstated at
the discretion of NIOSH after it receives satisfactory assurances and
evidence that all deficiencies have been corrected and that effective
controls have been instituted to prevent a recurrence.
(d) Chest radiographs and other required documents must be
submitted only for miners.
(e) If a miner refuses to participate in all phases of the
examination prescribed in this subpart, no report need be made. If a
miner refuses to participate in any phase of the examination prescribed
in this subpart, all forms must be submitted with his or her name and
the last four digits of the Social Security number on each. If any form
cannot be completed because of the miner's refusal, it must be marked
``Miner Refuses,'' and submitted to NIOSH. No submission will be made,
however, without a completed Miner Identification Document (CDC/NIOSH
2.9) containing the miner's name, address, last four digits of the
Social Security number and place of employment.
0
16. Revise Sec. 37.70 to read as follows:
Sec. 37.70 Review of classifications.
(a) Any miner who believes the classification 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.
(1) If the classification was based on agreement between an A
Reader and a B Reader, NIOSH will obtain one or more additional
classifications by B Readers as necessary to obtain agreement in
accordance with Sec. 37.53, and MSHA must report the results to the
miner together with notification from MSHA of any rights which may
accrue to the miner in accordance with Sec. 37.102.
(2) If the reported classification was based on agreement between
two (or more) B Readers, the reading will be accepted as conclusive and
the miner must be so informed by MSHA.
(b) Any operator who is directed by MSHA to transfer a miner to a
less dusty atmosphere based on the most recent examination may file a
written request with NIOSH to review its findings. The standards set
forth in paragraph (a) of this section apply and the operator and miner
will be notified by MSHA whether the miner is entitled to the option to
transfer.
0
17. 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, original film radiographs will be
made available for examination only at the NIOSH facility in
Morgantown, WV.
0
18. Revise the subpart heading above Sec. 37.90 to read as follows:
Subpart--Spirometry Testing
0
19. Revise Sec. 37.90 to read as follows:
Sec. 37.90 Scope.
Under this subpart, coal mine operators are required to provide
spirometry testing to both current and newly employed coal miners,
using medical facilities approved by NIOSH in accordance with standards
established in this subpart.
0
20. Revise Sec. 37.91 to read as follows:
Sec. 37.91 Definitions.
Definitions provided in Sec. 37.2 will have the same meaning in
this subpart. Any term defined in the Federal Mine Safety and Health
Act of 1977 (Pub. L. 95-164, as amended) and not defined in Sec. 37.2
or this section will have the meaning given it in the Act. As used in
this subpart:
ATS means American Thoracic Society.
ERS means European Respiratory Society.
FET means forced expiratory time, which is the time from the
beginning of a forced exhalation (the back-extrapolated ``time zero'')
maneuver to the end of expiration.
FEV1 means forced expiratory volume in one second, which is the
greatest volume of air that can be forcibly blown out within the first
second, after full inspiration.
FEV1/FVC means the ratio between the largest acceptable FEV1 and
the largest acceptable FVC following the forced vital capacity
maneuver. It is usually reported as a percentage.
FEV6 means forced expiratory volume in six seconds, which is the
greatest volume of air that can forcibly be blown out in six seconds,
after full inspiration.
FVC means forced vital capacity, which is the greatest volume of
air that can forcibly be blown out after full inspiration.
PEF means peak expiratory flow, which is the maximal airflow
generated during a forced vital capacity maneuver.
Spirometry test means a pulmonary function test that measures
expiratory volume and airflow rates and may determine the presence and
severity of lung function impairments, if such are present.
0
21. Revise Sec. 37.92 to read as follows:
Sec. 37.92 Spirometry testing required for miners.
(a) Voluntary tests. Each operator must provide to all miners who
are employed in or at any of its coal mines the opportunity to have a
spirometry test and a respiratory assessment at no cost to the miner at
least once every 5 years in accordance with this subpart. The tests
will be available during a 6-month period that begins no less than 3.5
years and not more than 4.5 years from the end of the last 6-month
period.
(b) Mandatory tests. Every operator must provide to each miner who
begins work in or at a coal mine for the first time on or after August
1, 2014, spirometry testing and respiratory assessment at no cost to
the miner in accordance with this subpart.
(1) Initial spirometry testing and respiratory assessment will be
provided to all miners who begin work in or at a coal mine for the
first time on or after August 1, 2014 within the first 30 days of their
employment or within 30 days of approval of a plan to provide
spirometry testing.
(2) A follow-up second spirometry test and respiratory assessment
will be provided to the miner no later than 3 years after the initial
spirometry if the miner is still engaged in coal mining.
(3) A third spirometry test and respiratory assessment will be
provided no later than 2 years after the tests in paragraphs Sec.
37.3(b)(2) and paragraph (b)(2) of this section if the chest radiograph
shows evidence of pneumoconiosis as defined in Sec. 37.3(b)(3) or if
the second spirometry test results demonstrate a 15 percent or greater
decline in the percent predicted FEV1 value since the initial (i.e.,
baseline) test.
(i) Percent predicted FEV1 will be calculated according to
prediction equations published in Spirometric Reference Values from a
Sample of the General U.S. Population, American Journal of Respiratory
and Critical Care Medicine, 159(1):179-187, January 1999 (incorporated
by reference, see Sec. 37.98).
(ii) A correction factor to Caucasian reference values will be
applied when testing individuals of Asian descent as
[[Page 73287]]
specified in the ATS Technical Standards: Spirometry in the
Occupational Setting, p. 987 (incorporated by reference, see Sec.
37.98).
(c) Notification. NIOSH will notify the miner when he or she is due
to receive the second or third mandatory test under paragraph (b) of
this section. NIOSH will notify the coal mine operator when the miner
is to perform a second spirometry test.
(1) The operator will be notified of a miner's eligibility for a
third test only with the miner's written consent. The notice to the
operator will not state the medical reason for the test or that it is
the third test in the series.
(2) If the miner is notified by NIOSH that the third mandatory test
is due and the operator is not so notified, availability of spirometry
testing under the NIOSH-approved operator's plan will constitute the
operator's compliance with the requirement to provide a third
spirometry test even if the miner does not take the test.
(d) Availability of spirometry testing. The opportunity for
spirometry to be available for purposes of this subpart must be
indicated in an operator's plan that has been submitted and approved in
accordance with this subpart.
0
22. Revise Sec. 37.93 to read as follows:
Sec. 37.93 Approval of spirometry facilities.
(a) Application for facility approval. Facilities seeking approval
to provide the spirometry testing specified under this subpart must
have the ability to provide spirometry of high technical quality. Thus,
NIOSH-approved facilities must meet the requirements specified in this
subpart for the following activities: Training of technicians who
perform the tests; conducting spirometry tests using equipment and
procedures that meet required specifications; collecting the
respiratory assessment form; transmitting data to NIOSH; and
communicating with miners as required for scheduling, testing, and
notification of results. Facilities seeking approval may apply to NIOSH
using the Spirometry Facility Certification document (CDC/NIOSH 2.14).
(b) Spirometry quality assurance. A spirometry quality assurance
program must be in place to minimize the rate of invalid test results.
This program must include all of the following components:
(1) Instrument calibration checks. Testing personnel must fully
comply with the 2005 ATS/ERS Standardisation of Spirometry guidelines
for instrument calibration check procedures, pp. 322-323, including
Table 3 (incorporated by reference, see Sec. 37.98).
(i) For volume spirometers, calibration check procedures must
include daily (day of testing) leak and volume accuracy checks. In
addition, volume linearity checks must be performed according to the
frequency established by the 2005 ATS/ERS guidelines.
(ii) For flow-type spirometers, calibration must be checked daily
by injecting 3 liters of air from a calibration syringe at 3 different
speeds (fast, medium, slow). Flow linearity must be checked weekly as
established by the 2005 ATS/ERS guidelines.
(iii) Instrument calibration check records must be maintained by
the facility and available for inspection by NIOSH, as deemed
necessary.
(2) Automated maneuver and test session quality checks. The
spirometer software must automatically perform quality assurance checks
on expiratory maneuvers during each spirometry testing session. Screen
displayed error messages must alert the technician to maneuver
acceptability and test session non-repeatability. Each spirometry test
session must have the goal of obtaining 3 acceptable with 2 repeatable
forced vital capacity maneuvers, as defined by the 2005 ATS/ERS
Standardisation of Spirometry, p. 325 (incorporated by reference, see
Sec. 37.98).
(3) Ongoing monitoring of test quality. Facilities must submit
spirometry results to NIOSH within 14 calendar days of testing as
specified in Sec. 37.96(c) to permit NIOSH to monitor test quality and
provide a results report to each miner. NIOSH may provide quality
performance feedback to the appropriate technician(s) along with
suggestions for improvement.
(4) Quality assurance audits. NIOSH may periodically conduct audits
to review tests submitted by approved facilities and assess the quality
of spirometry provided. Such audits may include a review of all
spirometry data obtained during a specified time period or review of
spirometry test data collected over time on selected miners.
(c) Noncompliance. If NIOSH determines that a facility is not
compliant with the policies and procedures specified in this subpart,
or determines as the result of a quality assurance audit as specified
in this section that a facility is not performing spirometry of
adequate quality, the facility will be notified of the deficiency. The
facility must promptly make appropriate arrangements for the deficiency
to be rectified.
(d) Revocation of approval. If a facility fails to rectify
deficiencies within 60 days of notification, NIOSH approval of the
facility may be revoked. 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 by the facility to prevent
a recurrence.
(e) Maintenance of records. When conducting spirometry tests
pursuant to this subpart, physicians and facilities must maintain the
results and analyses of these tests (including any hard copies or
digital files containing individual data, such as interpretations) in a
manner consistent with applicable statutes and regulations governing
the handling and protection of individually identifiable health
information, including, as applicable, the HIPAA Privacy and Security
Rules (45 CFR part 160 and 45 CFR part 164, subparts A, C, and E).
0
23. Revise Sec. 37.94 to read as follows:
Sec. 37.94 Respiratory assessment form.
As part of the spirometry testing and concurrent with it, personnel
at the facility must complete a Respiratory Assessment Form (CDC/NIOSH
2.13).
0
24. Revise Sec. 37.95 to read as follows:
Sec. 37.95 Specifications for performing spirometry tests.
(a) Persons administering spirometry tests. Each person
administering spirometry tests for the Coal Workers' Health
Surveillance Program must successfully complete a NIOSH-approved
spirometry training course and maintain a valid certificate by
periodically completing NIOSH-approved spirometry refresher training
courses, identified on the NIOSH Web site at https://www.cdc.gov/niosh/.
A copy of the certificate of completion from a NIOSH-approved
spirometry training or refresher course, with validation dates printed
on the document, must be available for inspection. NIOSH will assign
each person administering spirometry tests a unique identification
number, which must be entered into the spirometry system computer
whenever instrument quality assurance or miner testing is done or on
the Spirometry Results Notification Form (CDC/NIOSH 2.15).
(b) Spirometer specifications. Spirometry testing equipment must
meet the 2005 ATS/ERS Standardisation of Spirometry specifications for
spirometer accuracy and precision and real-time display size and
content, pp. 331-333, including Table 2 on p. 322 and Table 6 on p. 332
(incorporated by reference, see Sec. 37.98). Facilities must make
available for inspection written verification from a third-party
testing
[[Page 73288]]
laboratory (not the manufacturer or distributor) that the model of
spirometer being used has successfully passed its validation checks as
required by the Standardization of Spirometry; 1994 Update protocol,
Appendix B pp. 1126-1134, including Table C1 (incorporated by
reference, see Sec. 37.98). Facilities may request such documentation
from spirometer manufacturers. For each forced expiratory maneuver
submitted for a miner under this part, the spirometry data file must
retain a record of the parameters defined in the 2005 ATS/ERS
Standardisation of Spirometry, p. 335 including Table 8 (incorporated
by reference, see Sec. 37.98). Spirometers that provide electronic
transfer of spirometry data results files must use the format, content,
and data structure specified by the 2005 ATS/ERS Standardisation of
Spirometry, p. 335, or a procedure for data transfer that is approved
by NIOSH.
(c) Spirometry procedures. Administration of spirometry must
include the following:
(1) Miner Identification Document. The Miner Identification
Document (CDC/NIOSH (M)2.9), described in Sec. 37.20, must be
completed for each miner at the facility where spirometry is performed.
(2) Pre-test checklist. The Spirometry Pre-Test Checklist portion
of the Spirometry Results Notification Form (CDC/NIOSH 2.15) must be
completed prior to each spirometry session to identify possible
contraindications to testing, or factors that might affect results.
(3) Respiratory Assessment Form. A standardized Respiratory
Assessment Form (CDC/NIOSH 2.13) must be completed at the initial
spirometry and repeated at each spirometry testing procedure.
(4) Collection of anthropometric and demographic information. The
miner's standing height must be measured in stocking feet using a
stadiometer (or equivalent device) each time the miner performs
spirometry. The miner's weight must also be measured (in stocking
feet). The miner's birth date, race, and ethnicity must also be
recorded. These data will be entered into the spirometry system
computer and transmitted with the spirometry data file or, if required
under the facility's approval, on the Spirometry Results Notification
Form (CDC/NIOSH 2.15).
(5) Test procedures. Spirometry will be conducted in accordance
with test procedures defined in the 2005 ATS/ERS Standardisation of
Spirometry, pp. 323-326, and the Standardisation of Lung Function
Testing, Replies to Readers, pp. 1496-1498 (both incorporated by
reference, see Sec. 37.98).
(i) The technician must be able to view real-time testing display
screens as specified in the 2005 ATS/ERS Standardisation of Spirometry,
p. 322 (incorporated by reference, see Sec. 37.98).
(ii) A miner will be tested in the standing position, but may be
seated if he or she experiences lightheadedness or other signs or
symptoms that raise a safety concern relating to the standing position
during the spirometry test.
(d) Records retention. On-site records of the results will include
spirometry test reports and retention of all spirometry sessions, pre-
test checklists, and standardized respiratory assessment results in
electronic or printed format until notification to delete or render the
information inaccessible, as described in Sec. 37.100(b)(6)(ii), is
received from NIOSH.
0
25. Revise Sec. 37.96 to read as follows:
Sec. 37.96 Spirometry interpretations, reports, and submission.
(a) Interpretation of spirometry tests. Interpretations will be
carried out by physicians or other qualified health care professionals
with expertise in spirometry who have all required licensure and
privileges to provide this service in their State or Territory.
Interpretations must be carried out using procedures and criteria
consistent with recommendations in the ATS Technical Standards:
Spirometry in the Occupational Setting, pp. 987-990, and the ATS/ERS
Interpretative Strategies for Lung Function Tests, p. 950, p. 956
including Table 5, and p. 957 including Table 6 (both incorporated by
reference, see Sec. 37.98).
(b) Spirometry reports at NIOSH-approved spirometry facilities. (1)
Spirometry test reports must contain the following:
(i) The miner's age, height, gender, race, and weight;
(ii) Numerical values (FVC, FEV6, FEV1, FEV1/FVC, FEV1/FEV6, FET,
and PEF) and volume-time and flow-volume spirograms for all recorded
expiratory maneuvers; normal reference value set used; and the
predicted, percent predicted, and lower limit of normal threshold
values;
(iii) Miner position during testing (standing or sitting);
(iv) Dates of test and last calibration check;
(v) Ambient temperature and barometric pressure (volume
spirometers); and
(vi) The technician's unique identification number.
(2) NIOSH will notify the submitting facility when to permanently
delete or, if this is not technologically feasible for the spirometry
system used, render permanently inaccessible all files and forms
associated with a miner's spirometry test from its electronic and
physical files.
(c) Submission of spirometry results. Facilities must submit
results of spirometry tests electronically with content as specified in
Sec. 37.96(b), completed pre-test screening checklists (found in
Spirometry Results Notification Form CDC/NIOSH 2.15), and completed
Respiratory Assessment Form (CDC/NIOSH 2.13) within 14 calendar days of
testing a miner.
(1) Electronic spirometry test results. Submission of spirometry
test results in the form of an electronic data file in a format
approved by NIOSH is preferred. Facilities must utilize a secure
internet data transfer site specified by NIOSH. Data submission must be
performed as specified in the facility's approval. The transmitted
spirometry data files must include a variable length record providing
all parameters in the format, content, and data structure described by
the 2005 ATS/ERS Standardisation of Spirometry, p. 335 including Table
8 (incorporated by reference, see Sec. 37.98), or an alternate data
file that is approved by NIOSH.
(2) Spirometry test results submitted using the Spirometry Results
Notification form. If specified under a facility's approval, spirometry
results may be provided using the Spirometry Results Notification Form
(CDC/NIOSH 2.15). The form must be completed and submitted
electronically, accompanied by image files in a format approved by
NIOSH that documents the flow-volume and volume-time curves for each
trial reported on the form. The method of electronic submission must be
approved by NIOSH and carried out securely as specified for electronic
data files in Sec. 37.96(c)(1).
(d) Confidentiality of spirometry results. Individual medical
information and spirometry results are considered protected health
information under HIPAA and may only be released as specified by HIPAA
or to NIOSH, as discussed in paragraph (d)(1) of this section, and
maintained by the spirometry facility as specified in Sec. 37.93(e).
(1) Personally identifiable information in the possession of NIOSH
will be released only with the written consent of the miner or, if the
miner is deceased, the written consent of the miner's next of kin or
legal representative.
(2) To provide on-site back-up and assure complete data transfer,
facilities must retain the forms and results (in electronic or paper
format) from a
[[Page 73289]]
miner's test until instruction has been received from NIOSH to delete
the associated files and forms or, if this is not technologically
feasible, render the data permanently inaccessible.
0
26. Revise Sec. 37.97 to read as follows:
Sec. 37.97 Notification of spirometry results.
(a) Findings must be communicated to the miner or, if requested by
the miner, to the miner's designated physician. The health care
professional at the NIOSH-approved facility must inform the miner if
the spirometry shows abnormal results or if the respiratory assessment
suggests he or she may benefit from the medical follow-up or a smoking
cessation intervention.
(b) NIOSH will notify the miner of his or her spirometry test
results, a comparison between current and previously submitted
spirometry tests (if available), and will advise the miner to contact a
health care professional as appropriate based on the results.
0
27. Add Sec. 37.98 to read as follows:
Sec. 37.98 Standards incorporated by reference.
(a) Certain material is incorporated by reference into this
subpart, Subpart--Spirometry Testing, with the approval of the Director
of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To
enforce any edition other than that specified in this section, NIOSH
must publish notice of change in the Federal Register and the material
must be available to the public. All approved material is available for
inspection at NIOSH, Respiratory Health Division, 1095 Willowdale Road,
Morgantown, WV 26505. To arrange for an inspection at NIOSH, call 304-
285-5749. Copies are also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030 or go to
https://www.archives.gov/federal_register/code_of_federal_regulations/ibv_locations.html.
(b) American Journal of Respiratory and Critical Care Medicine,
American Thoracic Society (ATS), 25 Broadway, 18th Floor, New York, NY
10004. Phone: (800) 635-7181, extension 8065. Email:
Hope.Robinson@sheridan.com. https://www.atsjournals.org/action/showHome:
(1) Standardization of Spirometry; 1994 Update. Official Statement
of the ATS, adopted November 11, 1994. American Journal of Respiratory
and Critical Care Medicine 152(3):1107-1136, September 1995, into Sec.
37.95(b). This ATS Official Statement is also available at https://www.atsjournals.org/doi/pdf/10.1164/ajrccm.152.3.7663792.
(2) Official American Thoracic Society Technical Standards:
Spirometry in the Occupational Setting (``ATS Technical Standards:
Spirometry in the Occupational Setting''). Redlich CA, Tarlo SM,
Hankinson JL, Townsend MC, Eschenbacher WL, Von Essen SG, Sigsgaard T,
and Weissman DN. American Journal of Respiratory and Critical Care
Medicine 189(8):983-994, April 15, 2014, into Sec. Sec. 37.92(b) and
37.96(a).
(3) Spirometric Reference Values from a Sample of the General U.S.
Population. Hankinson JL, Odencrantz JR, Fedan KB. American Journal of
Respiratory and Critical Care Medicine, 159(1):179-187, January 1999,
into Sec. 37.92(b).
(c) European Respiratory Journal, 442 Glossop Road, Sheffield, S10
2PX, UK. Phone: 44 114 267 28 60; Fax: 44 114 266 50 64. Email:
info@ersj.org.uk. https://erj.ersjournals.com/.
(1) Standardisation of Spirometry (``2005 ATS/ERS Standardisation
of Spirometry''). ATS/ERS Task Force: Standardization of Lung Function
Testing. Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R,
Coates A, Crapo R, Enright P, van der Grinten CPM, Gustafsson P, Jensen
R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino
R, Viegi G, and Wanger J. European Respiratory Journal 26(2):319-338,
August 2005, into Sec. Sec. 37.93(b); 37.95(b) and (c); and 37.96(c).
The ATS/ERS Standardisation of Spirometry is also available on the ATS
Web site at https://www.thoracic.org/statements/resources/pfet/PFT2.pdf.
(2) Interpretative Strategies for Lung Function Tests (``ATS/ERS
Interpretative Strategies for Lung Function Tests''). ATS/ERS Task
Force: Standardisation of Lung Function Testing. Pellegrino R, Viegi G,
Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten
CPM, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N,
McKay R, Miller MR, Navajas D, Pedersen OF, and Wanger J. European
Respiratory Journal 26(5):948-968, November 2005, into Sec. 37.96(a).
The ATS/ERS Standardisation of Lung Function Testing is also available
on the ATS Web site at https://www.thoracic.org/statements/resources/pft/pft5.pdf.
(3) Standardisation of Lung Function Testing, the Authors' Replies
to Readers' Comments (``Standardisation of Lung Function Testing,
Replies to Readers''). Miller MR, Hankinson J, Brusasco V, Burgos F,
Casaburi R, Coates A, Enright P, van der Grinten C, Gustafsson P,
Jensen R, MacIntyre N, McKay RT, Pedersen OF, Pellegrino R, Viegi G,
and Wanger J. European Respiratory Journal 36(6):1496-1498, December
2010, into Sec. 37.95(c). The Standardisation of Lung Function
Testing, Replies to Readers is also available on the ATS Web site at
https://www.thoracic.org/statements/resources/pft/clarification-12-2010.pdf.
0
28. Revise Sec. 37.100 to read as follows:
Sec. 37.100 Coal mine operator plan for medical examinations.
(a) Each coal mine operator must submit and receive NIOSH approval
of a plan for the provision of chest radiographs, occupational
histories, spirometry tests, and respiratory assessments of miners,
using the appropriate forms provided by NIOSH.
(1) During the transition from August 1, 2014 until the time when
spirometry facilities are approved by NIOSH, any person becoming a coal
mine operator on or after August 1, 2014, or any coal mine operator
without an approved plan as of that date must submit a plan within 60
days that provides for chest radiographs and occupational histories
only.
(2) Coal mine operators with previously approved plans for only
chest radiographs and occupational histories, or with plans developed
pursuant to paragraph (a)(1) of this section, will be notified by MSHA
when the plans must be amended to include spirometry testing and
respiratory assessments. Amendments must be submitted to NIOSH within
60 days of MSHA's notification.
(b) The coal mine operator's plan must include:
(1) The name, address, and telephone number of the operator(s)
submitting the plan;
(2) The name, MSHA identification number for respirable dust
measurements, and address of the mine included in the plan;
(3) The proposed beginning and ending date of the 6-month period(s)
for voluntary radiography exams and spirometry tests (see Sec. Sec.
37.3(a) and 37.92(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 radiograph and spirometry
facility or facilities, and the approximate date(s) and time(s) of day
during which the radiograph examination and spirometry will be given to
miners to enable a determination of whether the examinations will be
conducted at a convenient time and place;
[[Page 73290]]
(5) If a mobile medical examination facility is proposed to provide
some or all of the surveillance tests specified in paragraph (a) of
this section, the plan must provide that each miner be given adequate
notice of the opportunity to have the examination and that no miner
will have to wait for an examination more than 1 hour before or after
his or her work shift. The plan must include:
(i) The number of change houses at the mine.
(ii) One or more alternate non-mobile approved medical examination
facilities for the reexamination of miners and for the mandatory
examination of miners when necessary (see Sec. Sec. 37.3(b) and
37.92(b)), or an assurance that the mobile facility will return to the
location(s) specified in the plan as frequently as necessary to provide
for medical surveillance examinations in accordance with these
regulations.
(iii) The name and location of each change house at which
examinations will be given. For mines with more than one change house,
the examinations must be given at each change house or at a change
house located at a convenient place for each miner.
(6) Assurances that:
(i) The operator will not solicit a physician's spirometric,
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 spirograms or copies of spirograms
(including copies of electronic files) and 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 all related electronic files must be permanently deleted from
the facility records or rendered permanently inaccessible following the
confirmed transfer of such data to NIOSH, and that (except as may be
necessary for the purpose of this part) the physician's spirometric,
radiographic and other findings, as well as the occupational history
and respiratory assessment information obtained from a miner will not
be disclosed in a manner that would permit identification of the
individual miner with his or her information; and
(iii) The spirometry and radiographic examinations will be made at
no charge to the miner.
(c) Operators may provide for alternate spirometry or radiography
facilities in plans submitted to NIOSH for approval.
(d) The change of operators of any mine operating under a plan
approved pursuant to Sec. 37.101(a) must not affect the plan of the
operator which has transferred responsibility for the mine. Every plan
is subject to revision in accordance with paragraph (e) of this
section.
(e) The operator must advise NIOSH of any change in its plan. Each
change in an approved plan is subject to the same review and approval
as the originally approved plan.
(f) The operator must promptly display in a visible location on the
bulletin board at the mine its proposed plan or proposed change in a
NIOSH-approved plan when it is submitted to NIOSH. The proposed plan or
change in a NIOSH-approved plan must remain posted in a visible
location on the bulletin board until NIOSH either grants or denies
approval at which time the approved plan or denial of approval must be
permanently posted. In the case of an operator who does not have a
bulletin board, such as an operator that is a contractor, the operator
must otherwise notify its employees of the examination arrangements.
Upon request, the contractor must show NIOSH written evidence that its
employees have been notified.
(g) Upon notification from NIOSH that sufficient time has elapsed
since the previous period of examinations, the operator must resubmit a
plan for each of its coal mines to NIOSH for approval for the next
period of examinations (see Sec. Sec. 37.3(a)(2) and 37.92(a)). The
plan must include the proposed beginning and ending dates of the next
period of examinations and all information required by paragraph (b) of
this section.
0
29. Revise Sec. 37.101 to read as follows:
Sec. 37.101 Approval of plans.
(a) If, after review of any plan submitted pursuant to this
subpart, NIOSH 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, NIOSH will approve the plan and notify
the operator 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 NIOSH has reason to believe that it will deny approval of
a plan NIOSH will, prior to the denial, give notice in writing to the
operator(s) of an opportunity to amend the plan. The notice must
specify the ground(s) upon which approval is proposed to be denied.
(c) If a plan is denied approval, NIOSH will advise the operator(s)
in writing of the reasons for the denial and inform MSHA that the plan
was denied.
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30. Revise Sec. 37.102 to read as follows:
Sec. 37.102 Transfer of affected miner to less dusty area.
(a) Any miner who, in the judgment of NIOSH, has evidence of the
development of pneumoconiosis, must be afforded the option of
transferring from his or her position to another position in an area of
the mine where the concentration of respirable dust in the mine
atmosphere is in compliance with the MSHA requirements in 30 CFR part
90. A classification of one or more of the miner's chest radiographs as
showing 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 pneumoconiosis, or
complicated pneumoconiosis (ILO Classification) will be accepted as
such evidence. NIOSH will, at its discretion, also accept other medical
examinations provided to NIOSH for review, such as computed tomography
scans of the chest or lung biopsies, as evidence of the development of
pneumoconiosis.
(b) Any transfer under this section shall be in accordance with the
procedures specified in 30 CFR part 90.
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31. Revise Sec. 37.103 to read as follows:
Sec. 37.103 Medical examination at miner's expense.
Any miner who wishes to obtain a medical examination at the miner's
own expense at an approved spirometry or radiography 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
radiographic classification, evaluation of spirometry test results, and
reporting of the results of examinations made at the miner's expense in
the same manner as if they were submitted under an operator's plan. Any
change in the miner's transfer rights under the Act that may result
from this examination will be subject to the terms of Sec. 37.102.
Dated: October 4, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-24405 Filed 10-21-16; 8:45 am]
BILLING CODE 4163-19-P
