42CFR- part 37

Federal Register / Vol. 85, No. 31 / Friday, February 14, 2020 / Proposed Rules
make. The EPA will generally not
consider comments or comment
contents located outside of the primary
submission (i.e. on the web, cloud, or
other file sharing system). For
additional submission methods, please
contact the person identified in the FOR
FURTHER INFORMATION CONTACT section.
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submissions, and general guidance on
making effective comments, please visit
https://www.epa.gov/dockets/
commenting-epa-dockets. Publicly
available docket materials are available
at https://www.regulations.gov or at the
U.S. Environmental Protection Agency,
EPA Region 1 Regional Office, Air and
Radiation Division, 5 Post Office
Square—Suite 100, Boston, MA. EPA
requests that if at all possible, you
contact the contact listed in the FOR
FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional
Office’s official hours of business are
Monday through Friday, 8:30 a.m. to
4:30 p.m., excluding legal holidays.
Bob
McConnell, Environmental Engineer,
Air and Radiation Division (Mail Code
05–2), U.S. Environmental Protection
Agency, Region 1, 5 Post Office Square,
Suite 100, Boston, Massachusetts
02109–3912; (617) 918–1046.
[email protected].

FOR FURTHER INFORMATION CONTACT:

In the
Final Rules Section of this Federal
Register, EPA is approving the State’s
SIP submittal as a direct final rule
without prior proposal because the
Agency views this as a noncontroversial
submittal and anticipates no adverse
comments. A detailed rationale for the
approval is set forth in the direct final
rule. If no adverse comments are
received in response to this action rule,
no further activity is contemplated. If
EPA receives adverse comments, the
direct final rule will be withdrawn and
all public comments received will be
addressed in a subsequent final rule
based on this proposed rule. EPA will
not institute a second comment period.
Any parties interested in commenting
on this action should do so at this time.
Please note that if EPA receives adverse
comment on an amendment, paragraph,
or section of this rule and if that
provision may be severed from the
remainder of the rule, EPA may adopt
as final those provisions of the rule that
are not the subject of an adverse
comment.
For additional information, see the
direct final rule which is located in the
Rules Section of this Federal Register.

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SUPPLEMENTARY INFORMATION:

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Dated: January 30, 2020.
Dennis Deziel,
Regional Administrator, EPA Region 1.
[FR Doc. 2020–02226 Filed 2–13–20; 8:45 am]
BILLING CODE 6560–50–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 37
[Docket No. CDC–2019–0088; NIOSH–330]
RIN 0920–AA68

Coal Workers’ Health Surveillance
Program: B Reader Decertification and
Autopsy Payment
Centers for Disease Control and
Prevention, HHS.
ACTION: Notice of proposed rulemaking.
AGENCY:

HHS proposes to revise the
National Institute for Occupational
Safety and Health (NIOSH), Coal
Workers’ Health Surveillance Program
(Program) regulations by adding a
provision to allow NIOSH to suspend or
revoke B Reader certification.
Certification may be revoked for any B
Reader found by NIOSH to have
engaged in a pattern of providing
unreasonably inaccurate chest
radiograph classifications in practice—
those that are found by the Program to
diverge substantially from a competent
interpretation of the radiographs, as
determined by a panel of practicing,
certified B Readers selected by NIOSH.
In addition to the B Reader provisions,
HHS would also amend existing
regulatory text to allow compensation
for pathologists who perform autopsies
on coal miners at a market rate, on a
discretionary basis as needed for public
health purposes.
DATES: Comments must be received by
May 14, 2020. Comments on the
information collection approval request
sought under the Paperwork Reduction
Act must be received by April 14, 2020.
ADDRESSES: Written comments:
Comments may be submitted by any of
the following methods:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments to
the docket.
• Mail: NIOSH Docket Office, Robert
A. Taft Laboratories, MS–C34, 1090
Tusculum Avenue, Cincinnati, OH
45226.
Instructions: All submissions received
must include the agency name (Centers
for Disease Control and Prevention,
HHS) and docket number (CDC–2019–
0088; NIOSH–330) or Regulation
SUMMARY:

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Identifier Number (0920–AA68) for this
rulemaking. All relevant comments,
including any personal information
provided, will be posted without change
to http://www.regulations.gov. For
detailed instructions on submitting
public comments, see the ‘‘Public
Participation’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
FOR FURTHER INFORMATION CONTACT:
Rachel Weiss, Program Analyst; 1090
Tusculum Ave., MS: C–48, Cincinnati,
OH 45226; telephone (855) 818–1629
(this is a toll-free number); email
[email protected].
SUPPLEMENTARY INFORMATION:
I. Public Participation
Interested parties may participate in
this rulemaking by submitting written
views, opinions, recommendations, and
data. Comments received, including
attachments and other supporting
materials, are part of the public record
and subject to public disclosure. Do not
include any information in your
comment or supporting materials that
you do not wish to be disclosed. You
may submit comments on any topic
related to this notice of proposed
rulemaking.
II. Statutory Authority
The Federal Mine Safety and Health
Act of 1977 (Pub. L. 91–173, 30 U.S.C.
801 et seq.) (Mine Act), authorizes the
HHS Secretary (Secretary) to work with
coal mine operators to make available to
coal miners the opportunity to have
regular and routine chest radiographs
(X-rays) in order to detect coal workers’
pneumoconiosis (i.e., black lung) and
prevent its progression in individual
miners. The Mine Act grants the
Secretary general authority to issue
regulations as is deemed appropriate to
carry out provisions of the Act and
specifically directs that medical
examination of coal miners shall be
given in accordance with specifications
prescribed by the Secretary (30 U.S.C.
843(a), 957). The Mine Act also
authorizes the Secretary to establish
specifications for the reading of
radiographs and to pay for autopsies
submitted to the Program.
III. Background and Need for
Rulemaking
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 dust-induced
fibrotic lung disease (pneumoconiosis)
and chronic obstructive pulmonary
disease, including chronic bronchitis
and emphysema. To address such

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threats to the U.S. coal mining
workforce, the Mine Act was enacted in
1969 and amended in 1977, authorizing
the NIOSH Coal Workers’ Health
Surveillance Program, within the
Respiratory Health Division, 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 radiograph (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.
Under NIOSH supervision, chest
radiographs are assessed and a summary
report based on at least two
independent classifications (readings) of
each periodic chest radiograph is sent to
each participating coal miner, who then
has the opportunity to take action to
reduce further dust exposure if early
dust-induced lung disease is detected.
The combined results of these
radiographic examinations of miners
also enable NIOSH to track rates and
patterns of pneumoconiosis among the
participating miners.
B Readers
Pursuant to NIOSH Coal Workers’
Health Surveillance Program regulations
in 42 CFR 37.51 and 37.52, chest
radiographs taken for the Program are
assessed by qualified licensed physician
B Readers. B Readers are physicians
who have demonstrated proficiency in
the use of the International Labour
Office (ILO) Classification of
Radiographs of Pneumoconioses 1 by
taking and passing a specially-designed
proficiency examination offered by
NIOSH, as specified in 42 CFR 37.52.
The goal of the NIOSH B Reader
Program is to ensure competency in the
detection of pneumoconiosis by
evaluating the ability of readers to
classify a test set of radiographs, thereby
creating and maintaining a pool of
qualified readers having the skills and
ability to provide accurate and precise
1 International Labour Office [2011], Guidelines
for the use of ILO International Classification of
Pneumoconiosis, revised edition 2011, Geneva,
Switzerland: International Labour Office.
Occupational Safety and Health Series No. 22 (Rev.
2011).

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classifications in accordance with ILO
standards. The B Reader examination
currently offered by NIOSH consists of
the classification of 125 chest
radiographs over the course of 6 hours;
the test addresses proficiency in
classification of small opacities, large
opacities, pleural abnormalities, and
certain other abnormalities that may
appear in the lung radiographs. In order
to maintain B Reader status, B Readers
must take and pass the B Reader
recertification exam every 5 years.
B Readers participate in the NIOSH
Coal Workers’ Health Surveillance
Program, as well as other national and
state programs addressing dust-related
illnesses,2 and are also involved with
epidemiologic evaluations, surveillance,
and worker monitoring programs
involving many types of
pneumoconioses. In applying the ILO
Classification, B Readers compare sets
of standard images, which represent
different types of abnormalities and
levels of disease severity, with images of
the individual being evaluated to
identify parenchymal abnormalities
(small and large opacities), pleural
changes, and other features that can
occur in chest radiographs of
individuals with pneumoconiosis. In
the current ILO Classification, the B
Reader is first asked to grade film
quality and then to categorize small
opacities according to their presence,
shape and size, location, and profusion.
Large opacities are classified according
to their presence and size. The B Reader
also assesses the presence, location,
width, extent, and degree of
calcification of pleural abnormalities as
well as provides a description of
additional features related to dust
exposure and other etiologies visible on
the chest radiograph.3
The classification of chest radiographs
is semi-quantitative and relies on the B
Reader’s professional judgment,
comparing case radiographs to the ILO
standard classification radiographs.
Skilled B Readers can disagree about the
presence of disease, particularly in a
radiograph with borderline findings, or
differ somewhat in classifying the
severity of disease. However, since the
beginning of the Program in the 1970s,
the NIOSH Respiratory Health Division
2 Other examples of national compensation
programs that use B Readers include the
Department of Labor, Office of Workers’
Compensation Programs (OWCP), Division of Coal
Mine Workers’ Compensation, Black Lung Program;
and the Asbestos Medical Surveillance Program,
administered by the Navy and Marine Corps Public
Health Center.
3 NIOSH [2015], Chest Radiograph Classification,
CDC/NIOSH form (M) 2.8, http://www.cdc.gov/
niosh/topics/surveillance/ords/pdfs/CWHSPReadingForm-2.8.pdf.

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has occasionally learned of B Readers
found to provide unreasonably
inaccurate radiograph classifications in
formal litigation and compensation
proceedings relative to the actual
features of the chest radiographs in
question. ‘‘Unreasonably inaccurate’’
classifications are those that diverge
substantially from a competent
interpretation of the radiographs and are
unsupported by the chest radiographs in
question, as determined by a panel of
practicing, certified B Readers selected
by NIOSH. For example, one B Reader
was accused of ‘‘under-reading’’ chest
radiographs, frequently not identifying
severe cases of pneumoconiosis that
may have been indicated by the
radiographs; 4 another was accused of
‘‘over-reading,’’ frequently identifying
asbestosis where the radiographs were
subsequently found not to support that
determination.5 The Program
regulations in 42 CFR part 37 do not
currently provide a mechanism for
NIOSH to take remedial action
addressing such B Readers.
Autopsies
The Mine Act also authorizes HHS to
provide for coal miner autopsies and to
pay for their submission to NIOSH.
Autopsies can be used for public health
purposes such as studying the emerging
issue of rapidly progressive and severe
pneumoconiosis in coal miners by
assessing its pathology and lung content
of mineral particles relative to what was
seen in the past. Also, autopsies are
sometimes requested after mine
disasters. The current regulatory
language, promulgated over 45 years
ago, provides for payments to
pathologists up to $200; today,
autopsies generally cost between $2,000
and $3,000. As a result, very few
autopsies of coal miners are provided to
the Coal Workers’ Health Surveillance
Program and the Autopsy Program is
rarely used. Increasing the
compensation rate would make it
possible for pathologists to conduct
autopsies of coal miners, thereby
allowing the NIOSH Respiratory Health
Division to better study pneumoconiosis
in contemporary coal miners and to
more thoroughly perform public health
investigations, especially in the
aftermath of mine disasters.
4 The Center for Public Integrity [2013], Johns
Hopkins Medical Unit Rarely Finds Black Lung,
Helping Coal Industry Defeat Miners’ Claims,
https://publicintegrity.org/environment/johnshopkins-medical-unit-rarely-finds-black-lunghelping-coal-industry-defeat-miners-claims/.
5 Fisher D [2012], Law Firm Hit with $429,000
Verdict over Faked Asbestos Suits, Forbes, https://
www.forbes.com/sites/danielfisher/2012/12/21/lawfirm-hit-with-429000-verdict-over-faked-asbestossuits/#14f1d2f92325.

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Federal Register / Vol. 85, No. 31 / Friday, February 14, 2020 / Proposed Rules
IV. Summary of Proposed Rule
To promote administrative efficiency
and ensure program integrity, HHS
proposes to amend 42 CFR part 37 by
adding a new paragraph (d) to § 37.52,
to allow NIOSH to take remedial action
for any B Reader found by NIOSH to
have engaged in a pattern of providing
chest radiograph classifications in
practice that are found by the Program
to be unreasonably inaccurate, as
determined by a panel of practicing,
certified B Readers selected by NIOSH.
Remedial actions may be taken at
NIOSH’s discretion or in response to a
complaint from any interested party or
at the discretion of the Coal Workers’
Health Surveillance Program. To ensure
that NIOSH can identify those B Readers
who provide unreasonably inaccurate
classifications to compensation
programs, a valid complaint from any
interested party must provide the chest
radiograph(s) and ILO classification(s)
being contested, as well as a letter from
a medical professional supporting the
complaint that the classification was
unreasonable. A new § 37.52(d)(1)
would describe the complaint process.
Paragraph (d)(1)(i) would define
‘‘unreasonably inaccurate’’
classifications as those that a panel of B
Readers would unanimously determine
are substantially divergent from a
competent interpretation of the
radiographs and are unsupported by the
radiographs in question. Paragraph
(d)(1)(ii) would describe the elements of
a valid complaint; paragraph (d)(1)(iii)
would describe an invalid complaint.
A new § 37.52(d)(2) would describe
the procedures that would be used by
NIOSH to determine whether an
individual B Reader has engaged in a
pattern of providing unreasonably
inaccurate chest radiographs in practice.
Complaint investigations would involve
a panel of at least four B Readers who
would independently review the
information provided in each
complaint. If at least one B Reader on
the panel finds that the contested
classification is reasonable, no further
review will be conducted. If the B
Readers on the panel independently and
unanimously conclude that the
classification is not reasonable, the
actions described in paragraphs
(d)(2)(ii)–(v) will be taken.
In accordance with the new
provisions in § 37.52(d)(2), the
certification of a B Reader who is under
investigation will remain in good
standing until the Program issues its
final decision regarding remedial
actions. If three independent complaint
investigations conclude that an
individual B Reader has engaged in a

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pattern of providing unreasonably
inaccurate chest radiographs in practice,
the B Reader’s certification will be
permanently revoked.
A new paragraph (d)(3) would
establish an appeal process for those B
Readers whose certifications have been
revoked by the Coal Workers’ Health
Surveillance Program.
HHS is also considering permitting
the revocation or suspension of B
Reader certifications for demonstrated
patterns of violating the B Reader’s Code
of Ethics. The Code of Ethics is available
on the NIOSH website at https://
www.cdc.gov/niosh/topics/
chestradiography/breader-ethics.html,
and would be included in part 37 as an
appendix should this option be adopted.
HHS encourages comments on this
matter.
In addition to the proposed regulatory
language on remediating inaccurate B
Readers, HHS would also amend
existing regulatory text in §§ 37.202
through 37.204 to allow NIOSH, on a
discretionary basis as needed for public
health purposes, to better compensate
pathologists who perform autopsies on
coal miners. Existing text in § 37.202(a)
would be revised to clarify that
pathologists must secure prior
authorization from NIOSH and have
legal consent to conduct an autopsy on
a coal miner. New language in
§ 37.202(a)(2)(i) and (ii) would clarify
the types of chest radiographs accepted
by the Program, and new language in
§ 37.202(b) would specify that
pathologists would be compensated in
accordance with the ordinary, usual, or
customary fee charged by other
pathologists for the same services.
Section 37.203 would be revised to
update the reference for standard
autopsy procedures. Finally, new
language in § 37.204(a) would detail the
new requirement that the pathologist
obtain written authorization from the
NIOSH Respiratory Health Division
prior to completion of the autopsy.
Existing language specifying how claims
for payment should be submitted to
NIOSH would be reorganized.
In existing § 37.201(b), the definition
of Miner would be revised to remove the
word ‘‘underground,’’ to clarify that the
autopsy provisions pertain to all coal
miners. Section 37.201(d) would also be
revised to update the definition of
‘‘NIOSH,’’ clarifying that the name of
the NIOSH division responsible for
administering the Coal Workers’ Health
Surveillance Program is now the
Respiratory Health Division.

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V. Regulatory Assessment
Requirements
A. Executive Order 12866 (Regulatory
Planning and Review) and Executive
Order 13563 (Improving Regulation and
Regulatory Review)
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). E.O. 13563 emphasizes the
importance of quantifying both costs
and benefits, of reducing costs, of
harmonizing rules, and of promoting
flexibility.
This proposed rule has been
determined not to be a ‘‘significant
regulatory action’’ under section 3(f) of
E.O. 12866. The revisions proposed in
this notice would allow NIOSH to take
remedial action addressing any B
Readers who frequently provide chest
radiograph classifications in practice
that are determined by the Program to
be unreasonably inaccurate. Part 37
would also be revised to allow NIOSH
to compensate pathologists at a
contemporary rate for autopsies
submitted to the Coal Workers’ Health
Surveillance Program.
The proposed revisions to Part 37
would not impose significant costs on
the public and would benefit coal
miners and coal mine operators.
Depending on the types of unreasonably
inaccurate classifications they provide,
B Readers can compromise the health of
and benefits owed to coal miners who
have pneumoconiosis by under-reading
or cause unnecessary emotional distress
to miners and unnecessary costs for
mine operators by over-reading.
Allowing the NIOSH Respiratory Health
Division to take remedial actions
addressing these B Readers through
suspension or revocation of their B
Reader certifications would ensure that
these adverse outcomes were minimized
or avoided. Allowing the NIOSH
Respiratory Health Division to better
compensate pathologists for autopsies
submitted to the Program would also
ensure that NIOSH is able to study
pneumoconiosis in coal miners.
The costs to the Federal government
of administering these revisions would
be minor and infrequent. NIOSH
estimates that over a 5-year period, it
might conduct two evaluations of B
Readers, costing NIOSH approximately
$3,000. Over the same period, NIOSH
estimates it might fund up to 20

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autopsies, costing NIOSH approximately
$60,000.
The only costs potentially imposed on
the public would be borne by B Readers
whose certifications are suspended or
revoked. NIOSH estimates that over a 5year period it might suspend or revoke
certifications for one B Reader.
However, conducting B Reader medical
examinations is generally infrequent
within a physician’s medical practice,
and moreover, other medical procedures
similarly compensated would likely
substitute for conducting B Reader
examinations. It is not possible to
reasonably estimate whether such costs
would arise and, if so, their level and
frequency.
B. Executive Order 13771 (Reducing
Regulation and Controlling Regulatory
Costs)
Executive Order 13771 requires
executive departments and agencies to
eliminate at least two existing
regulations for every new significant
regulation that imposes costs. HHS has
determined that this rulemaking is costneutral because it does not require any
new action by stakeholders. The
rulemaking ensures that coal miners
properly receive compensation for their
occupational illness and that NIOSH
can more thoroughly study the
development of pneumoconiosis.
Because OMB has determined that this
rulemaking is not significant, pursuant
to E.O. 12866, and because it does not
impose costs, OMB has determined that
this rulemaking is exempt from the
requirements of E.O. 13771. Thus it has
not been reviewed by OMB.

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C. 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. HHS certifies that

this proposed rule has ‘‘no significant
economic impact upon a substantial
number of small entities’’ within the
meaning of the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.).
D. Paperwork Reduction Act
The Paperwork Reduction Act (PRA),
44 U.S.C. 3501 et seq., requires an
agency to invite public comment on,
and to obtain Office of Management and
Budget (OMB) approval of, any
regulation that requires 10 or more
people to report information to the
agency or to keep certain records. In
accordance with section 3507(d) of the
PRA, HHS has determined that the PRA
does apply to information collection
and recordkeeping requirements
included in this rule. OMB has already
approved the information collection and
recordkeeping requirements under OMB
Control Number 0920–0020, National
Coal Workers’ Health Surveillance
Program (CWHSP) (expiration date 9/
30/2021). HHS has determined that the
proposed amendments in this
rulemaking would not impact the
existing collection of data but would
add two new items to the approval: B
Reader challenge and appeal, and the
pathologist prior authorization request.
To request more information or to
obtain a copy of the data collection
plans and instruments, you may call
404–639–5960; send comments to
Kimberly S. Lane, 1600 Clifton Road,
MS–D74, Atlanta, GA 30333; or send an
email to [email protected].
Comments are invited on the
following: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the Agency, including
whether the information shall have
practical utility; (b) the accuracy of the
Agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be

collected; and (d) ways to minimize the
burden of the collection of information
on respondents. Written comments
should be received within 60 days of the
publication of this notice. The addition
of additional paperwork requirements
resulting from this proposed rule will
increase the burden associated with the
following provisions:
Section 37.52 Proficiency in the use of
systems for classifying the
pneumoconioses. This section
establishes the process for certifying B
Readers. Of the 167 B Readers currently
certified and the approximately
additional 200 who will be certified
over the next 10 years, HHS anticipates
that no more than three B Readers may
be disciplined over time. Of those, HHS
expects two B Readers to challenge or
appeal the decision to take disciplinary
action; if all decisions are challenged
and the final decision to revoke
certification is appealed, NIOSH would
receive up to eight letters (for each of
the four final disciplinary decisions).
HHS estimates that the challenge or
appeal letter will take no more than 30
minutes to complete, totaling 4 hours
annually. There will be no form
associated with this collection.
Section 37.204 Procedure for
obtaining payment. This section would
establish that a pathologist who wants
to submit an autopsy to the Coal
Workers’ Health Surveillance Program
must first obtain written authorization
from the NIOSH Respiratory Health
Division. HHS expects that the number
of requests will vary substantially from
year-to-year. For example, more requests
might be granted following a mine
disaster. Over a period of years, HHS
expects an average of about four
requests for prior authorization
annually. HHS estimates that each
request for prior authorization will take
no more than 15 minutes to complete,
averaging about 1 hour annually over a
period of years.
Average
burden per
response
(min)

Responses
per
respondent

Number of
respondents

Total burden
(hr)

Section

Title

37.52 ....................

2

4

30/60

4

37.204 ..................

Challenge to disciplinary action and appeal of decertification decision.
Autopsy prior authorization ............................................

4

1

15/60

1

Total ..............

........................................................................................

........................

........................

........................

5

E. 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

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seq.), HHS will report the promulgation
of this rule to Congress prior to its
effective date.

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F. 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

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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 proposed
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.
G. Executive Order 12988 (Civil Justice
Reform)
This proposed rule has been drafted
and reviewed in accordance with
Executive Order 12988 and will not
unduly burden the Federal court
system. This rule has been reviewed
carefully to eliminate drafting errors and
ambiguities.
H. Executive Order 13132 (Federalism)
HHS has reviewed this proposed 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.’’
I. 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 proposed rule on children. HHS
has determined that the rule would have
no environmental health and safety
effect on children.

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J. 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 proposed rule on energy supply,
distribution or use, and has determined
that the rule will not have a significant
adverse effect.
K. Plain Writing Act of 2010
Under Public Law 111–274 (October
13, 2010), executive Departments and
Agencies are required to use plain
language in documents that explain to
the public how to comply with a
requirement the Federal government
administers or enforces. HHS has
attempted to use plain language in
promulgating the proposed rule

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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, Part 90
miner, Part 90 transfer rights,
Pneumoconiosis, Respiratory and
pulmonary diseases, Silicosis,
Spirometry, Surface coal mining,
Underground coal mining, X-rays.
Proposed Rule
For the reasons discussed in the
preamble, the Department of Health and
Human Services proposes to amend 42
CFR part 37 as follows:
PART 37—SPECIFICATIONS FOR
MEDICAL EXAMINATIONS OF 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. Revise § 37.52 by adding paragraph
(d) to read as follows:

■

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

*

*
*
*
*
(d) Remedial Actions. (1) Any
interested party may make a complaint
to the NIOSH Coal Workers’ Health
Surveillance Program against any B
Reader who routinely provides chest
radiograph classifications in practice
that are believed to be unreasonably
inaccurate.
(i) Inaccurate classifications are those
that fail to identify small or large
opacities in lung fields, pleural changes,
and other features indicating the
presence of lung disease where they
exist, or those that identify small or
large opacities, pleural changes, and
other features where they do not exist.
Unreasonably inaccurate classifications
are those that a panel of B Readers
would unanimously determine are
substantially divergent from a
competent interpretation of the
radiographs and are unsupported by the
chest radiographs in question.
(ii) A valid complaint must be
submitted to the NIOSH Coal Workers’
Health Surveillance Program,
Respiratory Health Division, and
include the chest radiographs and ILO
classifications being contested as well as
a letter of support from a medical
professional. A complaint that
demonstrates more than a reasonable
difference of opinion will be considered
valid.

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(iii) A complaint that fails to include
any required element will be considered
invalid, and the NIOSH Respiratory
Health Division will notify the
complainant that no further
investigation will occur.
(2) Investigations may be initiated at
NIOSH’s discretion or in response to a
valid complaint, pursuant to paragraph
(d)(1) of this section, to determine
whether a B Reader has provided chest
radiograph classifications in practice
that are unreasonably inaccurate.
(i) Investigations will include the
following:
(A) The NIOSH Respiratory Health
Division will choose a panel of at least
four B Readers who will independently
review the information provided in each
valid complaint.
(B) If one or more of the B Readers on
the panel independently determines
that the classification being contested is
reasonable, the NIOSH Respiratory
Health Division will conclude that the
classification being contested is
reasonable. The complainant will be
notified of the finding and no further
action will be conducted.
(C) If the B Readers on the panel
independently and unanimously concur
that the classification being contested is
unreasonable, remedial actions will be
taken by the NIOSH Respiratory Health
Division pursuant to paragraphs
(d)(2)(ii) through (v) of this section,
accordingly.
(ii) If, after an investigation, a panel
of B Readers unanimously finds that the
classification contested in a complaint
is unreasonably inaccurate, the Program
will issue an initial report to the B
Reader under review. If the B Reader
chooses not to challenge the initial
report within 30 days, the initial report
becomes a final determination. If the B
Reader chooses to challenge the initial
report, the Coal Workers’ Health
Surveillance Program will respond
within 90 days; the Program’s decision
is final. The first final report may be
considered a warning that further
misclassification of small or large
opacities or other types of pleural
abnormalities will result in suspension
or revocation of the B Reader’s
certification.
(iii) If, after an investigation, a panel
of B Readers unanimously finds that the
classification contested in a second
complaint is unreasonably inaccurate,
the Program will issue an initial report
to the B Reader under review. If the B
Reader chooses not to challenge the
initial report within 30 days, the initial
report becomes a final determination. If
the B Reader chooses to challenge the
initial report, the Coal Workers’ Health
Surveillance Program will respond

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within 90 days, during which time the
B Reader’s certification will remain in
good standing; the Program’s decision is
final and may result in the 1-year
suspension of the B Reader’s
certification with the 1-year period
beginning on the date the Program
issues the final decision letter. The
suspended B Reader must take and pass
the certification examination at the
conclusion of the suspension period in
order to be reinstated.
(iv) If, after an investigation, a panel
of B Readers unanimously finds that the
classification contested in a third
complaint is unreasonably inaccurate,
the Program will issue an initial report
to the B Reader under review. If the B
Reader chooses not to challenge the
initial report within 30 days, the initial
report becomes a final determination. If
the B Reader chooses to challenge the
initial report, the Coal Workers’ Health
Surveillance Program will respond
within 90 days, during which time the
B Reader’s certification will remain in
good standing; the Program’s decision is
final, unless the B Reader successfully
appeals the decision pursuant to
§ 37.52(d)(3), and will result in
permanent revocation of the B Reader’s
certification beginning on the date the
Program issues the final decision letter.
(v) If the first complaint is found to be
valid and to demonstrate a pattern of
inaccurate chest radiograph
classifications, the Program will issue
an initial report to the B Reader under
review and immediately apply the
procedures in paragraph (d)(2)(iv) of
this section. To demonstrate a pattern of
inaccurate classifications, the valid
complaint must provide radiographs
from three or more patients conducted
within a one-year period that are
determined by the Program to be
inaccurate.
(3) A B Reader whose certification is
revoked after three final adverse
determinations is no longer a certified B
Reader. Such B Reader may appeal the
Coal Workers’ Health Surveillance
Program’s decision to revoke the B
Reader’s certification.
(i) An appeal request must be
submitted in writing to the NIOSH
Respiratory Health Division Director,
signed and postmarked within 30
calendar days of the date of the letter
notifying the B Reader of the
decertification decision. Electronic
versions of the signed appeal request
letter will also be accepted.
(ii) The appeal request must state the
reason(s) the B Reader believes the
decertification decision is incorrect and
should be reversed. The appeal request
may include scientific or medical
information correcting factual errors,

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any information demonstrating that the
decertification decision was not
reasonable, and/or relevant new
information not previously considered
by the Coal Workers’ Health
Surveillance Program.
(iii) The appeal request must be sent
to the NIOSH Respiratory Health
Division Director at the address
specified in the decertification letter.
(iv) The NIOSH Respiratory Health
Division Director will review the Coal
Workers’ Health Surveillance Program
decision and any relevant information
provided by the B Reader and make a
final decision on the appeal. The
Director will notify the B Reader of the
following in writing:
(A) The Director’s final decision on
the appeal;
(B) An explanation of the reason(s) for
the Director’s final decision on the
appeal; and
(C) Any administrative actions taken
by the Coal Workers’ Health
Surveillance Program.
■ 3. Revise § 37.201 to read as follows:
§ 37.201

Definitions.

As used in this subpart:
(a) Secretary means the Secretary of
Health and Human Services.
(b) Miner means any individual who
during his/her life was employed in any
coal mine.
(c) Pathologist means
(1) A physician certified in anatomic
pathology or pathology by the American
Board of Pathology or the American
Osteopathic Board of Pathology,
(2) A physician who possesses
qualifications which are considered
board-eligible by the American Board of
Pathology or American Osteopathic
Board of Pathology, or
(3) An intern, resident, or other
physician in a training program in
pathology who performs the autopsy
under the supervision of a pathologist as
defined in paragraph (c) (1) or (2) of this
section.
(d) NIOSH means the National
Institute for Occupational Safety and
Health, located within the Centers for
Disease Control and Prevention (CDC).
Within NIOSH, the Respiratory Health
Division (formerly called the Division of
Respiratory Disease Studies and the
Appalachian Laboratory for
Occupational Safety and Health) is the
organizational unit that has
programmatic responsibility for the
medical examination and surveillance
program.
■ 4. Revise § 37.202 to read as follows:
§ 37.202

Payment for autopsy.

(a) NIOSH may, at its discretion, pay
any pathologist who has received prior

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authorization from NIOSH pursuant to
§ 37.204(a), and with legal consent:
(1) Performs an autopsy on a miner in
accordance with this subpart; and
(2) Submits the findings and other
materials to NIOSH in accordance with
this subpart within 180 calendar days
after having performed the autopsy.
(i) Types of chest radiographic images
accepted for submission include a
digital chest image (posteroanterior
view) provided in an electronic format
consistent with the DICOM standards
described in § 37.42(c)(5), a chest
computed tomography provided in an
electronic format consistent with
DICOM standards, or a good-quality
copy or original of a film chest
radiograph (posteroanterior view).
(ii) More than one type of chest
radiographic image may be submitted.
(b) Pathologists will be compensated
in accordance with the ordinary, usual,
or customary fee charged by other
pathologists for the same services, at the
discretion of NIOSH. NIOSH will
additionally compensate a pathologist
for the submission of chest radiographic
images made of the subject of the
autopsy within 5 years prior to his/her
death together with copies of any
interpretations made.
(c) A pathologist who receives any
other specific payment, fee, or
reimbursement in connection with the
autopsy from the miner’s widow/
widower, his/her family, his/her estate,
or any other Federal agency will not
receive compensation from NIOSH.
■ 5. Revise § 37.203 to read as follows:
§ 37.203 Autopsy specifications.

(a) Each autopsy for which a claim for
payment is submitted pursuant to this
subpart must be performed in a manner
consistent with standard autopsy
procedures such as those, for example,
set forth in Autopsy Performance &
Reporting, third edition (Kim A. Collins,
ed., College of American Pathologists,
2017). Copies of this document may be
borrowed from NIOSH.
(b) Each autopsy must include:
(1) Gross and microscopic
examination of the lungs, pulmonary
pleura, and tracheobronchial lymph
nodes;
(2) Weights of the heart and each lung
(these and all other measurements
required under this subparagraph must
be in the metric system);
(3) Circumference of each cardiac
valve when opened;
(4) Thickness of right and left
ventricles; these measurements must be
made perpendicular to the ventricular
surface and must not include
trabeculations or pericardial fat. The
right ventricle must be measured at a

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point midway between the tricuspid
valve and the apex, and the left
ventricle must be measured directly
above the insertion of the anterior
papillary muscle;
(5) Size, number, consistency,
location, description and other relevant
details of all lesions of the lungs;
(6) Level of the diaphragm;
(7) From each type of suspected
pneumoconiotic lesion, representative
microscopic slides stained with
hematoxylin eosin or other appropriate
stain, and one formalin fixed, paraffinimpregnated block of tissue; a minimum
of three stained slides and three blocks
of tissue must be submitted. When no
such lesion is recognized, similar
material must be submitted from three
separate areas of the lungs selected at
random; a minimum of three stained
slides and three formalin fixed, paraffinimpregnated blocks of tissue must be
submitted.
(c) Needle biopsy techniques will not
be accepted.
■ 6. Revise § 37.204 to read as follows:

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§ 37.204

Procedure for obtaining payment.

(a) Prior to performing an autopsy, the
pathologist must obtain written
authorization from NIOSH and
agreement regarding payment amount
for services specified in § 37.202(a) by
submitting an Authorization for
Payment of Autopsy (form CDC
#0.1585).
(1) NIOSH will maintain up-to-date
information about the availability of
payments on its website. If payments are
not available, the online Authorization
of Payment for Autopsy form will not be
active and available for completion on
the NIOSH website.
(2) After receiving a completed
authorization request form, NIOSH will
reply in writing with an authorization
determination within 3 working days.
(b) After performance of an autopsy,
each claim for payment under this
subpart must be submitted to NIOSH
and must include:
(1) An invoice (in duplicate) on the
pathologist’s letterhead or billhead
indicating the date of autopsy, the
amount of the claim and a signed
statement that the pathologist is not
receiving any other specific
compensation for the autopsy from the
miner’s widow/widower, his/her
surviving next-of-kin, the estate of the
miner, or any other source.
(2) Completed Consent, Release and
History Form for Autopsy (CDC/NIOSH
(M)2.6). This form may be completed
with the assistance of the pathologist,
attending physician, family physician,
or any other responsible person who can
provide reliable information.

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(3) Report of autopsy:
(i) The information, slides, and blocks
of tissue required by this subpart.
(ii) Clinical abstract of terminal illness
and other data that the pathologist
determines is relevant.
(iii) Final summary, including final
anatomical diagnoses, indicating
presence or absence of simple and
complicated pneumoconiosis, and
correlation with clinical history if
indicated.
Dated: January 10, 2020.
Alex M. Azar II
Secretary, Department of Health and Human
Services.
[FR Doc. 2020–02705 Filed 2–13–20; 8:45 am]
BILLING CODE 4163–218–P

FEDERAL MARITIME COMMISSION
46 CFR Part 530
[Docket No. 20–02]
RIN 3072–AC80

Service Contracts
Federal Maritime Commission.
Notice of proposed rulemaking.

AGENCY:
ACTION:

The Federal Maritime
Commission (FMC or Commission)
proposes to amend its rules governing
Service Contracts. The proposed rule is
intended to reduce regulatory burden.
DATES: Submit comments on or before:
April 14, 2020.
In compliance with the Paperwork
Reduction Act, the Commission is also
seeking comment on revisions to one
information collections. See the
Paperwork Reduction Act section under
Regulatory Analyses and Notices below.
Please submit all comments relating to
the revised information collections to
the Commission and to the Office of
Management and Budget (OMB) at the
address listed in the ADDRESSES section
on or before April 14, 2020. Comments
to OMB are most useful if submitted
within 30 days of publication.
ADDRESSES: You may submit comments
identified by the Docket No. 20–02 in
the heading of this document, by the
following methods:
• Email: [email protected]. Include
in the subject line: ‘‘Docket No. 20–02,
Comments on Proposed Service
Contract Regulations.’’ Comments
should be attached to the email as a
Microsoft Word or text-searchable PDF
document. Comments containing
confidential information should not be
submitted by email.
• Mail: Rachel E. Dickon, Secretary,
Federal Maritime Commission, 800
SUMMARY:

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North Capitol Street NW, Washington,
DC 20573–0001. Phone: (202) 523–5725.
Email: [email protected].
• Comments regarding the revised
information collections should be
submitted to the Commission through
one of the preceding methods and a
copy should also be sent to the Office
of Information and Regulatory Affairs,
Office of Management and Budget,
Attention: Desk Officer for Federal
Maritime Commission, 725 17th Street
NW, Washington, DC 20503; by Fax:
(202) 395–5167; or by email: OIRA_
[email protected].
Instructions: For detailed instructions
on submitting comments, including
requesting confidential treatment of
comments, and additional information
on the rulemaking process, see the
Public Participation heading of the
Supplementary Information section of
this document. Note that all comments
received will be posted without change
to the Commission’s website, unless the
commenter has requested confidential
treatment.
Docket: For access to the docket to
read background documents or
comments received, go to the
Commission’s Electronic Reading Room
at: https://www2.fmc.gov/readingroom/
proceeding/20-02/, or to the Docket
Activity Library at 800 North Capitol
Street NW, Washington, DC 20573, 9:00
a.m. to 5:00 p.m., Monday through
Friday, except Federal holidays.
Telephone: (202) 523–5725.
FOR FURTHER INFORMATION CONTACT: For
questions regarding submitting
comments or the treatment of
confidential information, contact Rachel
E. Dickon, Secretary. Phone: (202) 523–
5725. Email: [email protected]. For
technical questions, contact Florence A.
Carr, Director, Bureau of Trade
Analysis, Federal Maritime
Commission, 800 North Capitol Street
NW, Washington, DC 20573–0001.
Phone: (202) 523–5796. Email:
[email protected].
SUPPLEMENTARY INFORMATION:
Introduction
On September 18, 2018, the Federal
Maritime Commission (FMC or
Commission) issued a Notice of Filing
and Request for Comments to obtain
public comments on Petition No. P3–18,
the petition of the World Shipping
Council (WSC), (Petitioner) pursuant to
46 CFR 502.92 ‘‘. . . for an exemption
from service contract filing and essential
terms publication requirements set forth
at 46 U.S.C 40502(b) and (d),
respectively . . .’’ Petitioner further
petitions the Commission for the
initiation of a rulemaking proceeding to

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