[Federal Register Volume 78, Number 114 (Thursday, June 13, 2013)]
[Rules and Regulations]
[Pages 35549-35559]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13970]



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Rules and Regulations
                                                Federal Register
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Federal Register / Vol. 78, No. 114 / Thursday, June 13, 2013 / Rules 
and Regulations

[[Page 35549]]



DEPARTMENT OF LABOR

Office of Workers' Compensation Programs

20 CFR Parts 718 and 725

RIN 1240-AA07


Black Lung Benefits Act: Standards for Chest Radiographs

AGENCY: Office of Workers' Compensation Programs, Labor.

ACTION: Direct final rule; request for comments.

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SUMMARY: Physicians and adjudicators use chest radiographs (X-rays) as 
a tool in evaluating whether a coal miner suffers from pneumoconiosis 
(black lung disease). Accordingly, the Department's regulations 
implementing the Black Lung Benefits Act allow the submission of 
radiographs in connection with benefit claims and set out quality 
standards for their performance. These standards are currently limited 
to film radiographs. In recent years, many medical facilities have 
phased out film radiography in favor of digital radiography. This 
direct final rule updates the existing film-radiograph standards and 
provides parallel standards for digital radiographs. This rule also 
updates outdated terminology and removes certain obsolete provisions.

DATES: This direct final rule is effective September 11, 2013, without 
further action unless OWCP receives significant adverse comment to this 
rule by midnight Eastern Standard Time on August 12, 2013. The 
incorporation by reference of certain publications listed in the rule 
is approved by the Director of the Federal Register as of September 11, 
2013. If OWCP receives significant adverse comment, it will publish a 
timely withdrawal of the rule in the Federal Register.

ADDRESSES: You may submit written comments, identified by RIN number 
1240-AA07, by any of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions on the Web site for submitting comments. To 
facilitate receipt and processing of comments, OWCP encourages 
interested parties to submit their comments electronically.
     Fax: (202) 693-1395 (this is not a toll-free number). Only 
comments of ten or fewer pages, including a Fax cover sheet and 
attachments, if any, will be accepted by Fax.
     Regular Mail: Division of Coal Mine Workers' Compensation 
Programs, Office of Workers' Compensation Programs, U.S. Department of 
Labor, Room C-3520, 200 Constitution Avenue NW., Washington, DC 20210. 
The Department's receipt of U.S. mail may be significantly delayed due 
to security procedures. You must take this into consideration when 
preparing to meet the deadline for submitting comments.
     Hand Delivery/Courier: Division of Coal Mine Workers' 
Compensation Programs, Office of Workers' Compensation Programs, U.S. 
Department of Labor, Room C-3520, 200 Constitution Avenue NW., 
Washington, DC 20210.
    Instructions: All submissions received must include the agency name 
and the Regulatory Information Number (RIN) for this rulemaking. All 
comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Steven Breeskin, Director, Division of 
Coal Mine Workers' Compensation, Office of Workers' Compensation 
Programs, U.S. Department of Labor, 200 Constitution Avenue NW., Suite 
N-3464, Washington, DC 20210. Telephone: (202) 693-0824 (this is not a 
toll-free number). TTY/TDD callers may dial toll-free 1-800-877-8339 
for further information.

SUPPLEMENTARY INFORMATION: 

I. Direct Final Rulemaking and Relationship With Companion Proposed 
Rule

    In direct final rulemaking, an agency publishes a direct final rule 
in the Federal Register with a statement that the rule will go into 
effect unless the agency receives significant adverse comment within a 
specified period. The agency concurrently publishes an identical 
proposed rule. If the agency receives no significant adverse comment in 
response to the direct final rule, the rule goes into effect. If the 
agency receives significant adverse comment, the agency withdraws the 
direct final rule and treats such comment as submissions on the 
proposed rule. An agency typically uses direct final rulemaking when it 
anticipates the rule will be non-controversial.
    OWCP has determined that this rule, which primarily adopts quality 
standards for administering and interpreting digital radiographs, is 
suitable for direct final rulemaking. The standards adopted by this 
rule are largely based on those the Department of Health and Human 
Services recently promulgated for use in the National Institute for 
Occupational Safety and Health (NIOSH) Coal Workers' Health 
Surveillance Program (CWHSP) (the NIOSH rules). Those standards were 
subject to full notice-and-comment rulemaking. The NIOSH proposal 
informed the public that the standards might also be used by the 
Department of Labor in the Black Lung Benefits Act (BLBA) context, and 
OWCP alerted the BLBA employer and claimant communities to the NIOSH 
proposed rule. NIOSH addressed all significant comments when it 
promulgated its final rule. OWCP's direct final rule also does not 
impose any new requirements on the parties in BLBA claims; instead, it 
merely provides the parties another option for developing medical 
evidence in claim proceedings. Thus, OWCP does not expect to receive 
significant adverse comment on this rule. In addition, using a direct 
final rule will expedite the rulemaking process to give parties the 
option of using digital radiographs as soon as possible.
    OWCP is also publishing a companion proposed rule in the ``Proposed 
Rules'' section of today's Federal Register to expedite notice-and-
comment rulemaking in the event OWCP receives significant adverse 
comment and

[[Page 35550]]

withdraws this direct final rule. The proposed and direct final rules 
are substantively identical, and their respective comment periods run 
concurrently. OWCP will treat comments received on the companion 
proposed rule as comments regarding the direct final rule and vice 
versa. Thus, if OWCP receives a significant adverse comment on either 
this direct final rule or the companion proposed rule, OWCP will 
publish a Federal Register notice withdrawing this direct final rule 
and proceed with the companion proposed rule. If no significant adverse 
comment is received, this direct final rule will become effective 
September 11, 2013.
    For purposes of this direct final rule, a significant adverse 
comment is one that explains: (1) Why the rule is inappropriate, 
including challenges to the rule's underlying premise or approach; or 
(2) why the direct final rule will be ineffective or unacceptable 
without a change. In determining whether a significant adverse comment 
necessitates withdrawal of this direct final rule, OWCP will consider 
whether the comment raises an issue serious enough to warrant a 
substantive response if it had been submitted in a standard notice-and-
comment process. A comment recommending an addition to the rule will 
not be considered significant and adverse unless the comment explains 
how this direct final rule would be ineffective without the addition.
    OWCP requests comments on all issues related to this rule, 
including economic or other regulatory impacts of this rule on the 
regulated community. All interested parties should comment at this time 
because OWCP will not initiate an additional comment period even if it 
withdraws the direct final rule.

II. Background of This Rulemaking

    The BLBA, 30 U.S.C. 901-944, provides for the payment of benefits 
to coal miners and certain of their dependent survivors on account of 
total disability or death due to coal workers' pneumoconiosis. 30 
U.S.C. 901(a); Usery v. Turner Elkhorn Mining Co., 428 U.S. 1, 5 
(1976). Benefits are paid by either an individual coal mine operator 
that employed the coal miner (or its insurance carrier), or the Black 
Lung Disability Trust Fund. Director, OWCP v. Bivens, 757 F.2d 781, 783 
(6th Cir. 1985). The primary purpose of this rulemaking is to update 
the quality standards applicable to chest radiographs (X-rays) used in 
diagnosing the existence of pneumoconiosis by implementing new 
standards for digital radiographs. The Department has also updated 
certain terminology and removed an obsolete provision as explained in 
the section-by-section analysis below.
    From the black lung program's inception, physicians and 
adjudicators have used chest X-rays as one tool in evaluating a miner's 
health. Recognizing their importance to claim adjudications, Congress 
has granted the Secretary of Labor explicit authority to, ``by 
regulation, establish specific requirements for the techniques used to 
take [chest X-rays]'' to ensure adequate and uniform X-ray quality. 30 
U.S.C. 923(b). The BLBA also generally authorizes the Secretary of 
Labor, in consultation with NIOSH, to ``establish criteria for all 
appropriate medical tests'' administered in connection with benefit 
claims. 30 U.S.C. 902(f)(1)(D).
    Based on these directives, the Department promulgated quality 
standards for administering and interpreting chest X-rays in 1980. See 
45 FR 13678, 13680-81 (February 29, 1980). Codified at 20 CFR 718.102, 
718.202, and Appendix A to Part 718, these standards were drawn largely 
from those adopted by NIOSH for what is now known as the Coal Workers' 
Health Surveillance Program (CWHSP). The CWHSP, mandated by the Coal 
Mine Health and Safety Act, was developed to detect coal workers' 
pneumoconiosis and prevent disease progression in individual miners, 
while at the same time providing information for evaluation of temporal 
and geographic trends in pneumoconiosis. 30 U.S.C. 843. To inform each 
miner of his or her health status, the CWHSP requires that underground 
coal mine operators offer new workers a chest X-ray through an approved 
facility as soon as possible after employment starts, another one three 
years later, and additional X-rays at periodic intervals thereafter. 
CWHSP chest X-rays must be administered and read in accordance with 
NIOSH's specifications. 30 U.S.C. 843(a). NIOSH set out these 
specifications--which included standards for administering, 
interpreting, classifying and submitting chest radiographs--for film-
based radiography systems in regulations at 42 CFR part 37.
    The Department modeled its 1980 BLBA chest X-ray quality standards 
on NIOSH's then-current regulations, which HHS had published on August 
1, 1978. 43 FR 33713 (August 1, 1978). In consultation with NIOSH, the 
Department adopted (with minor revisions) those NIOSH rules that were 
relevant to ensuring that quality X-ray films would be submitted in 
BLBA claims. See generally 45 FR 13680-81 (February 29, 1980). Although 
NIOSH later revised two of the 42 CFR part 37 regulations the 
Department had adopted, 52 FR 7866-01 (March 13, 1987), the Department 
did not make similar changes to the BLBA quality standards. Nor did the 
Department revise the technical requirements (including those in 
Appendix A) when it amended other facets of Sec.  718.102 and Sec.  
718.202 in 1983 and 2000. See 48 FR 24273-74 (May 31, 1983); 65 FR 
79929, 79945-46 (December 20, 2000). Thus, the Department's current 
technical quality standards for chest X-rays have not been changed 
since 1980.
    In the past decade, digital radiography systems have been rapidly 
replacing traditional analog film-based systems. Claimants, coal mine 
operators, and the Department have been experiencing increasing 
difficulty in obtaining film chest X-rays--the only type the BLBA 
quality standards address--for miners. Interpretations of digital X-
rays are admissible as ``other medical evidence'' under the catch-all 
provision at 20 CFR 718.107, but only if the interpretation's proponent 
establishes to the adjudicator's satisfaction that digital X-rays are 
medically acceptable and relevant to the claimant's entitlement to 
benefits. See generally Webber v. Peabody Coal Co., 23 BLR 1-123 (2006) 
(en banc); Harris v. Old Ben Coal Co., 23 BLR 1-98 (2006) (en banc), 
aff'd on recon., 24 BLR 1-13 (2007) (en banc). This has led to mixed 
results from adjudicators, with some admitting digitally based 
interpretations and others refusing to consider them or affording them 
less weight based on the technology employed.
    Recognizing the overarching technological shift from film to 
digital radiography systems, NIOSH recently promulgated new standards 
for administering, interpreting, classifying and submitting digital 
chest radiographs for the CWHSP. 77 FR 56718-56735 (September 13, 2012) 
(final rule). See also 77 FR 1360-1385 (January 9, 2012) (proposed 
rule). NIOSH adopted these rules only after fully investigating the 
validity of using digital chest X-rays for diagnosing pneumoconiosis 
and full notice-and-comment proceedings that allowed the public to 
participate. The NIOSH rules also retained the standards for film-based 
radiography systems with minor terminology modifications.
    This direct final rule retains the current regulatory quality 
standards for film-based chest X-rays (with the minor modifications 
explained in the section-by-section analysis below) and adds parallel 
quality standards for digitally acquired chest radiographs. As it did 
when it first promulgated quality standards for film-based chest X-
rays,

[[Page 35551]]

the Department has derived its digital-radiography standards from those 
adopted by NIOSH for the CWHSP. The Department believes this is 
appropriate because Congress designated NIOSH as its statutory advisor 
for establishing standards for BLBA medical testing. These standards 
will ensure that claim adjudications continue to be based on high-
quality, uniform radiographs. By adopting quality standards for 
digitally acquired chest X-rays, the Department intends that 
interpretations of film and digital X-rays--so long as they are made 
and interpreted in accordance with the applicable quality standards--
will be put on equal footing both for admission into evidence and for 
the weight accorded them. The Department believes that claimants, coal 
mine operators, and the BLBA program itself will benefit in a variety 
of ways from these new rules. The additional benefits are outlined in 
more detail below.

III. Statutory Authority

    Section 426(a) of the BLBA, 30 U.S.C. 936(a), authorizes the 
Secretary of Labor to prescribe all rules and regulations necessary for 
the administration and enforcement of the Act. The BLBA also authorizes 
the Secretary of Labor, in consultation with NIOSH, to ``establish 
criteria for all appropriate medical tests'' administered in connection 
with a benefits claim, 30 U.S.C. 902(f)(1)(D), and to ``establish 
specific requirements for the techniques used to take [X-rays] of the 
chest'' to ensure their quality. 30 U.S.C. 923(b).

IV. Section-by-Section Explanation

Updated Terminology

    The Department has made two changes throughout the regulatory 
sections and Appendix that this rule revises. First, the Department has 
replaced the outdated term ``roentgenogram'' with the term 
``radiograph,'' which is currently used in the medical community. See, 
e.g., Sec.  725.406(a).
    Second, the Department has replaced the term ``shall.'' Executive 
Order 13563 states that regulations must be ``accessible, consistent, 
written in plain language, and easy to understand.'' 76 FR 3821 
(January 21, 2011). See also E.O. 12866, 58 FR 51735 (October 4, 1993) 
(``Each agency shall draft its regulations to be simple and easy to 
understand, with the goal of minimizing the potential for uncertainty 
and litigation arising from such uncertainty.''). To that end, the 
Department has replaced the imprecise term ``shall'' in those sections 
and the Appendix it is amending with ``must'' for obligations imposed 
and ``must not'' for prohibitions. See generally Federal Plain Language 
Guidelines, http://www.plainlanguage.gov/howto/guidelines; Black's Law 
Dictionary 1499 (9th ed. 2009) (``shall'' can be read either as 
permissive or mandatory). These revisions required minor additional 
language changes in Sec.  718.202(a)(2), (b), and (c). No change in 
meaning is intended.

20 CFR 718.5 Incorporations by Reference

    This section is new. It was added to comply with the Office of the 
Federal Register's rules on incorporation by reference. The Director of 
the Federal Register has approved the Department's incorporation of the 
industry standards identified in Sec.  718.102 and Appendix A. This 
section also explains how the public may obtain copies of the 
incorporated materials.

20 CFR 718.102 Chest Radiographs (X-Rays)

    The Department has substantially revised Sec.  718.102 to allow 
parties the option of submitting X-rays that are produced either by 
film or digital radiography systems, and to otherwise update the rule. 
Because these changes required reorganization of the regulation, the 
Department is publishing the new regulation in its entirety. Each 
revision is described below.
    Subsection (a) has been retained and remains substantively 
unchanged.
    Subsection (b) is new. It specifically allows for the submission of 
X-rays produced by either film or digital radiography systems as those 
systems are defined in Appendix A. Prior subsection (b) has been 
amended and re-designated subsection (d).
    Subsection (c) is new. In accordance with the NIOSH standards, 
subsection (c) bans the use of X-rays that have been converted from 
film to digital, or vice-versa. NIOSH found that these approaches do 
not assure similar performance to that obtained from film under the 
existing standards. See 77 FR 1366 (January 9, 2012). Prior subsection 
(c) has been amended and re-designated subsection (e).
    Subsection (d) establishes the standards for classifying both film 
and digital radiographs. The regulation continues to direct that 
classifications be made in accordance with the International Labour 
Organization's (ILO) classification system. For film X-rays, subsection 
(d)(1) lists the 1980, 2000, and 2011 editions of the ILO Guidelines. 
The Department has included these three editions to clarify that film 
X-rays acquired prior to the issuance of this regulation and 
interpreted under the earlier editions continue to meet the quality 
standards. Radiographs acquired and interpreted after implementation of 
this rule should be classified in accordance with the 2011 Guidelines. 
For digitally acquired X-rays, subsection (d)(2) requires 
classification using the ILO's 2011 Guidelines. The 2011 edition is the 
first one in which the ILO authorized the use of its classification 
system for digital images and developed a set of standard digital image 
files for use during classification. A party who wishes to introduce 
digital X-ray interpretations that pre-date issuance of the ILO 2011 
Guidelines may still do so under the 20 CFR 718.107 ``other medical 
evidence'' standard. Subsection (d)(3) retains the provision that any 
X-ray classified as category 0 does not constitute evidence of clinical 
pneumoconiosis, whether acquired by film or digital systems. Finally, 
the Department has removed references to various classification systems 
published in 1958, 1968, and 1971 because they are obsolete.
    Subsection (e) retains the current requirement that X-ray reports 
must include the name and qualifications of the medical provider who 
took the X-ray; the name and qualifications of the physician who 
interpreted it, including whether the physician is a Board-certified or 
Board-eligible radiologist or a Certified B Reader; the ILO 
classification; and a compliance statement. Definitions for Board-
certified radiologist, Board-eligible radiologist, and Certified B 
Reader have been moved to subsection (e)(2) from their current location 
in 20 CFR 718.202(a)(1)(ii). The Department also updated the Certified 
B Reader definition by eliminating a reference to the Appalachian 
Laboratory for Occupational Safety and Health and adding a provision 
that the physician's certification must be maintained through the date 
he or she interprets the radiograph.
    Subsection (f) is largely new. It describes the protocol for 
submitting film and digital X-rays to OWCP. The current film protocol, 
previously set forth under subsection (d), remains unchanged. The 
Department has added a protocol for submitting digital X-rays that 
requires parties to submit the data on DVD or other media OWCP 
specifies in a format that meets the standards set forth in Appendix A, 
paragraph (d). These standards preclude compression of the data unless 
the compression is lossless. See Appendix A, paragraph (d)(7)(v).
    Subsection (g) allows an interpretation of a chest X-ray to be

[[Page 35552]]

submitted even in the absence of the underlying X-ray film or digital 
data file where the miner is deceased and the film or data upon which 
the report is based has been lost or destroyed. This provision, 
previously set forth in subsection (d), remains unchanged.
    Subsection (h) provides a rebuttable presumption that the technical 
requirements found in Appendix A have been met. This provision, 
previously set forth in subsection (e), remains unchanged except that 
the cross-reference to 20 CFR 718.202 for the definitions of Board- 
certified radiologist, Board-eligible radiologist, and Certified B 
Reader has been removed.

20 CFR 718.202 Determining the Existence of Pneumoconiosis

    In addition to moving the definitions for radiology qualifications 
to Sec.  718.102 (see explanation at Sec.  718.102), the Department has 
revised this regulation to eliminate outdated material. The Department 
has deleted subsections (a)(1)(i) and (ii), which implement the BLBA's 
X-ray rereading prohibition that applies only to claims filed before 
January 1, 1982. See 30 U.S.C. 923(b). Similarly, the Department has 
eliminated the phrase ``filed on or after January 1, 1982'' in the 
second sentence of subsection (c), which implements the BLBA's 
limitations on using lay evidence to prove pneumoconiosis, and 
reordered that provision for clarity. Few, if any, claims filed prior 
to January 1, 1982 remain in litigation. Thus, it is no longer 
necessary to publish the criteria governing these claims or to draw 
distinctions based on that date. If any claim filed before January 1, 
1982 results in litigation after the effective date of these 
regulations, and the X-ray rereading prohibition or the lay testimony 
provision is at issue, the version of Sec.  718.202(a)(1)(i), (a)(ii), 
and (c) as reflected in the 2011 edition of the Code of Federal 
Regulations will continue to apply.

20 CFR 718.304 Irrebuttable Presumption of Total Disability or Death 
Due to Pneumoconiosis

    The Department has revised this rule to update the references to 
the ILO classification system. Prior subsections (a)(1), (2), and (3) 
set forth several outdated classification systems that could be used to 
diagnose complicated pneumoconiosis. The Department has eliminated 
these provisions and added a phrase to the end of subsection (a) that 
cross-references Sec.  718.102(d): ``in accordance with the 
classification system established in Guidelines for the Use of the ILO 
International Classification of Radiographs of Pneumoconioses provided 
in Sec.  718.102(d).'' As explained above, Sec.  718.102(d) sets out 
the ILO classification systems that must be used when interpreting film 
and digital chest X-rays. This revision streamlines Sec.  718.304 and 
makes it consistent with Sec.  718.102(d).

Appendix A to Part 718--Standards for Administration and Interpretation 
of Chest Radiographs (X-Rays)

    Appendix A retains the current standards for acquiring chest X-rays 
using film-screen technology (with minor modifications) and establishes 
the standards for acquiring and interpreting chest X-rays using digital 
radiography systems.
    The Department has divided Appendix A into four primary sections: 
Paragraph (a) provides definitions applicable to either the film or 
digital chest X-ray standards, or both; paragraph (b) sets out general 
standards applicable to both film and digital X-rays; paragraph (c) 
retains the standards for film-based X-rays; and paragraph (d) 
establishes the new standards for acquiring and interpreting digital X-
rays. The initial paragraph of the Appendix, which describes the 
background and purpose of the standards, remains unchanged.
    Paragraph (a)'s definitions are adopted from the NIOSH rules and 
inform the remaining Appendix provisions.
    Paragraph (b) includes general provisions that are applicable when 
obtaining both film and digital chest radiographs. Subparagraph (b)(1) 
is new and requires that facilities performing chest X-rays must 
continue to meet applicable local, State, and Federal licensing and 
certification requirements. In order to minimize the miner's risk from 
radiation exposure, (b)(1) also recommends that facilities conform to 
recognized industry standards regarding such exposure in the absence of 
other governing regulations. Subparagraph (b)(2) mirrors the NIOSH 
rules and requires that radiographs be performed by a qualified 
physician or radiologic technologist. See 42 CFR 37.40(c). This 
provision applies to both film and digital radiographs. Although the 
Department has not previously imposed this requirement on film-based X-
rays, doing so should not pose any problems for the regulated community 
because it comports with standard industry practice and the term 
``radiologic technologist'' is broadly defined at Appendix A, 
subparagraph (a)(4). Finally, subparagraphs (b)(3) and (4) retain 
general rules for performing X-rays that currently appear in paragraphs 
(2) and (10).
    Paragraph (c) retains the existing standards for chest X-rays 
obtained by film with a few minor changes. For the sake of consistency 
with paragraph (d) of the Appendix, the Department has replaced the 
phrase ``1/20 of a second'' with 50 milliseconds, and the phrase ``1/10 
of a second'' with ``100 milliseconds'' in former subparagraph (8)(i) 
(now located at subparagraph (c)(7)(i)). No change in meaning is 
intended. The Department has also amended the film speed requirements 
in former subparagraph (8)(iii) (now located at subparagraph 
(c)(7)(iii)) by adopting the NIOSH rule. See 42 CFR 37.41(i)(3). This 
change clarifies that the use of medium-speed film and intensifying 
screens is recommended but not required. Finally, the Department has 
deleted the term ``densitometric'' in former paragraph (12) (now 
located at subparagraph (c)(10)) because it is unnecessary.
    Paragraph (d) is new and constitutes the bulk of the revisions to 
the Appendix. It sets out quality standards for acquiring chest 
radiographs using digital radiography systems as well as interpreting 
and transmitting them. As explained above, the Department adopted these 
provisions from the NIOSH rules. NIOSH fully explained these standards 
when it first proposed them and when it promulgated the final version. 
See 77 FR 56718-56735 (September 13, 2012) (final rule); 77 FR 1360-
1385 (January 9, 2012) (proposed rule). In adopting the rule, NIOSH 
emphasized that the burden imposed by the standards would be low 
because they reflected standard industry practice and technology (e.g., 
the DICOM standards). 77 FR 56724 (September 13, 2012); 77 FR 1372 
(January 9, 2012). Moreover, many of the facilities that participate in 
the CWHSP will also be used to provide X-rays for BLBA claims because 
they are located in coal mining regions. These facilities already 
adhere to the NIOSH criteria and will not have to change their 
practices for the BLBA program. Thus, for the reasons stated by NIOSH, 
the Department believes that adopting these standards will ensure the 
quality of digital X-rays.

V. Administrative Law Considerations

A. Information Collection Requirements (Subject to the Paperwork 
Reduction Act)

    This rulemaking imposes no new collections of information.

[[Page 35553]]

B. Executive Orders 12866 and 13563 (Regulatory Planning and 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). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. The Department has considered this rule with these 
principles in mind and has concluded that the regulated community will 
greatly benefit from this regulation.
    This rule's greatest benefit is that it will increase the amount of 
access the Department and the parties to BLBA claims have to 
radiographic technology. From the Department's view, this rule will 
likely reduce delays in processing miners' benefits claims. The 
Department must offer each miner who files a claim an opportunity for a 
complete pulmonary evaluation. 30 U.S.C. 923(b); 20 CFR 718.101(a), 
725.406. One component of that complete evaluation is a chest X-ray. 20 
CFR 725.406(a). In recent years, many medical providers otherwise 
qualified to perform these evaluations have declined because they do 
not have film-based radiography systems available to them. This has led 
to a shortage of examining physicians. Because this rule now allows for 
routine acceptance of digital radiographs, the Department anticipates 
that it will be able to increase the number of providers available to 
conduct the initial complete pulmonary evaluation and reduce some 
delays in claim processing.
    Claimants and coal mine operators (and their insurers) will 
similarly benefit. As the medical industry has transitioned from film 
to digital radiography systems over the past several years, the private 
parties have faced challenges in obtaining film-based X-rays. Miners 
have often had to travel long distances to obtain a film-based X-ray 
because the digital radiography services offered at a local clinic 
would not suffice. Not surprisingly, black lung claimants, coal-mine 
operators, and their representatives have repeatedly made informal 
requests for the Department to promulgate quality standards for digital 
X-rays.
    This rule also relieves parties of a demanding evidentiary burden 
they faced when submitting interpretations based on digital X-rays. 
Until now, digital X-ray interpretations have been admissible in BLBA 
claim proceedings, but only if the interpretation's proponent 
established to the adjudicator's satisfaction that digital X-rays are 
medically acceptable and relevant to the claimant's entitlement to 
benefits. See generally 20 CFR 718.107; Webber v. Peabody Coal Co., 23 
BLR 1-123 (2006) (en banc); Harris v. Old Ben Coal Co., 23 BLR 1-98 
(2006) (en banc), aff'd on recon., 24 BLR 1-13 (2007) (en banc). If the 
proponent failed to meet this burden, the adjudicator did not have to 
consider the evidence. This rule will relieve all parties of this 
additional proof burden, putting digital X-rays on a similar footing to 
film X-rays. So long as the regulatory quality standards are met, a 
party need not prove medical acceptability to have interpretations of 
digital X-rays admitted and considered.
    The Department has considered whether the parties will realize any 
monetary benefits or incur any additional costs in light of this rule, 
and has concluded that it is a cost-neutral rule for several reasons. 
The rule expands opportunities for claimants and coal mine employers to 
obtain X-ray evidence. But it does not require any party to use digital 
X-ray systems. Thus, even if obtaining digital X-rays proved more 
costly, absorbing that cost is optional. In addition, the Department 
believes that medical facilities generally do not have different fee 
structures for film and digital radiographs. Instead, standard medical 
coding systems (e.g., CPT codes) used to reimburse these facilities and 
process payments for chest X-rays use codes that do not reference the 
type of technology used to perform the X-rays. See, e.g., http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html. Finally, to the extent miners are able to 
go to digital X-ray facilities closer to their homes, their lower 
travel costs--which in some instances are paid either by the Department 
or passed on to the coal mine operator if the miner prevails on his 
benefits claim, 20 CFR 725.406(e)--will result in some minor savings.
    Executive Order 13563 also instructs agencies to review ``rules 
that may be outmoded, ineffective, insufficient, or excessively 
burdensome, and to modify, streamline, expand, or repeal them.'' As 
explained in the section-by-section analysis above, this rule revises 
obsolete terms (e.g., replacing ``roentgenogram'' with ``radiograph'' 
or ``X-ray'') and removes outmoded provisions (e.g., eliminating X-ray 
rereading prohibition provisions).
    Finally, because this is not a ``significant'' rule within the 
meaning of Executive Order 12866, the Office of Management and Budget 
has not reviewed it prior to publication.

C. 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.'' 2 U.S.C. 1531. For 
purposes of the Unfunded Mandates Reform Act, this rule does not 
include any Federal mandate that may result in increased expenditures 
by State, local, tribal governments, or increased expenditures by the 
private sector of more than $100,000,000.

D. Regulatory Flexibility Act and Executive Order 13272 (Proper 
Consideration of Small Entities in Agency Rulemaking)

    The Regulatory Flexibility Act of 1980, as amended, 5 U.S.C. 601 et 
seq. (RFA), requires agencies to evaluate the potential impacts of 
their proposed and final rules on small businesses, small 
organizations, and small governmental jurisdictions and to prepare an 
analysis (called a ``regulatory flexibility analysis'') describing 
those impacts. See 5 U.S.C. 601, 603-604. But if the rule is not 
expected to ``have a significant economic impact on a substantial 
number of small entities[,]'' the RFA allows an agency to so certify in 
lieu of preparing the analysis. See 5 U.S.C. 605.
    The Department has determined that a regulatory flexibility 
analysis under the RFA is not required for this rulemaking. While many 
coal mine operators are small entities within the meaning of the RFA, 
see 77 FR 19471-72 (March 30, 2012), this rule will not have a 
significant economic impact on them for several reasons. First, this 
rule does not require operators to obtain digital radiographs. By 
promulgating quality standards specific to digital X-rays, the 
Department is simply providing another option to coal mine operators 
(and their insurers) for developing medical evidence in the BLBA claims 
process. Operators are free to continue to use film-based technology. 
Second, even if an operator chooses to obtain digital radiographs, the 
Department believes that the cost for obtaining a digital X-ray will be 
comparable if not identical to a film-X-ray's cost. In considering this 
issue, the Department reviewed the medical reimbursement schedule 
published by the U.S. Department of Health and

[[Page 35554]]

Human Services Centers for Medicare and Medicaid Services (CMS). The 
CMS schedule, which forms the basis for many public and private 
reimbursement schemes, does not differentiate between film-based and 
digitally acquired chest X-rays; instead, the schedule lists 
reimbursement computation formulas for different types of chest X-rays 
without reference to the technology used to obtain them. See http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html). Moreover, NIOSH anticipates that lower 
costs for chest X-rays in general may result from medical facilities 
switching to digital radiography systems. See 77 FR 1372 (January 9, 
2012). Third, this rule is expected to benefit all coal mine operators 
by increasing access to medical facilities that exclusively use digital 
radiography or are transitioning to this technology.
    Based on these facts, the Department certifies that this rule will 
not have a significant economic impact on a substantial number of small 
entities. Thus, a regulatory flexibility analysis is not required. The 
Department invites comments from members of the public who believe the 
regulations will have a significant economic impact on a substantial 
number of small coal mine operators. The Department has provided the 
Chief Counsel for Advocacy of the Small Business Administration with a 
copy of this certification. See 5 U.S.C. 605.

E. 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.'' E.O. 13132, 64 FR 43255 (Aug. 4, 
1999). The proposed rule will 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.'' Id.

F. Executive Order 12988 (Civil Justice Reform)

    This rule meets the applicable standards in Sections 3(a) and 
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize 
litigation, eliminate ambiguity, and reduce burden. 61 FR 4729 (Feb. 5, 
1996).

G. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a report, which includes a copy of the rule, to 
each House of the Congress and to the Comptroller General of the United 
States. OWCP will report this rule's promulgation to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States simultaneously with publication of the rule in the 
Federal Register. The report will state that the rule is not a ``major 
rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 20 CFR Parts 718 and 725

    Black lung benefits, Claims, Coal miners' entitlement to benefits, 
Incorporation by reference, Survivors' entitlement to benefits, Total 
disability due to pneumoconiosis, Workers' compensation, X-rays.

    For the reasons set forth in the preamble, the Department of Labor 
amends 20 CFR parts 718 and 725 as follows:

PART 718--STANDARDS FOR DETERMINING COAL MINERS' TOTAL DISABILITY 
OR DEATH DUE TO PNEUMOCONIOSIS

0
1. The authority citation for part 718 is revised to read as follows:

    Authority: 5 U.S.C. 301; Reorganization Plan No. 6 of 1950, 15 
FR 3174; 30 U.S.C. 901 et seq., 902(f), 934, 936; 33 U.S.C. 901 et 
seq.; 42 U.S.C. 405; Secretary's Order 10-2009, 74 FR 58834.



0
2. Add Sec.  718.5 to Subpart A to read as follows:


Sec.  718.5  Incorporations by reference.

    (a) The materials listed in paragraphs (b) through (f) of this 
section are incorporated by reference in this part. The Director of the 
Federal Register has approved these incorporations by reference under 5 
U.S.C. 522(a) and 1 CFR Part 51. To enforce any edition other than that 
specified in these regulations, OWCP must publish notice of change in 
the Federal Register. All approved material is available from the 
sources listed below. You may inspect a copy of the approved material 
at the Division of Coal Mine Workers' Compensation, OWCP, U.S. 
Department of Labor, Washington, DC. To arrange for an inspection at 
OWCP, call 202-693-0046. These materials are also available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030 or go to http://www.archives.gov/federalregister/codeoffederalregulations/ibrlocations.html.
    (b) American Association of Physicists in Medicine, Order 
Department, Medical Physics Publishing, 4513 Vernon Blvd., Madison, WI 
53705, http://www.aapm.org/pubs/reports:
    (1) AAPM On-Line Report No. 03, Assessment of Display Performance 
for Medical Imaging Systems, April 2005, IBR approved for Appendix A to 
part 718, paragraph (d).
    (2) AAPM Report No. 93, Acceptance Testing and Quality Control of 
Photostimulable Storage Phosphor Imaging Systems, October 2006, IBR 
approved for Appendix A to part 718, paragraph (d).
    (c) American College of Radiology, 1891 Preston White Dr., Reston, 
VA 20191, http://www.acr.org/~/media/ACR/Documents/PGTS/guidelines/
Reference--Levels.pdf:
    (1) ACR Practice Guideline for Diagnostic Reference Levels in 
Medical X-Ray Imaging, Revised 2008 (Resolution 3), IBR approved for 
Appendix A to part 718, paragraph (d).
    (2) [Reserved]
    (d) International Labour Office, CH-1211 Geneva 22, Switzerland, 
http://www.ilo.org/publns:
    (1) Occupational Safety and Health Series No. 22, Guidelines for 
the Use of the ILO International Classification of Radiographs of 
Pneumoconioses, Revised edition 2011, IBR approved for Sec.  718.102(d) 
and Appendix A to part 718, paragraph (d).
    (2) Occupational Safety and Health Series No. 22 (Rev. 2000), 
Guidelines for the Use of the ILO International Classification of 
Radiographs of Pneumoconioses, Revised edition 2000, IBR approved for 
Sec.  718.102(d).
    (3) Occupational Safety and Health Series No. 22 (Rev. 80), 
Guidelines for the Use of ILO International Classification of 
Radiographs of Pneumoconioses, Revised edition 1980, IBR approved for 
Sec.  718.102(d).
    (e) National Council on Radiation Protection and Measurements, NCRP 
Publications, 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3095, 
Telephone (800) 229-2652, http://www.ncrppublications.org:
    (1) NCRP Report No. 102, Medical X-Ray, Electron Beam, and Gamma-
Ray Protection for Energies Up to 50 MeV (Equipment Design, 
Performance, and Use), issued June 30, 1989, IBR approved for Appendix 
A to part 718, paragraph (b).
    (2) NCRP Report No. 105, Radiation Protection for Medical and 
Allied Health Personnel, issued October 30,

[[Page 35555]]

1989, IBR approved for Appendix A to part 718, paragraph (b).
    (3) NCRP Report No. 147, Structural Shielding Design for Medical X-
Ray Imaging Facilities, revised March 18, 2005, IBR approved for 
Appendix A to part 718, paragraph (b).
    (f) National Electrical Manufacturers Association, 1300 N. 17th 
Street, Rosslyn, VA 22209, http://medical.nema.org:
    (1) DICOM Standard PS 3.3-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 3: Information Object Definitions, 
copyright 2011, IBR approved for Appendix A to part 718, paragraph (d).
    (2) DICOM Standard PS3.4-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 4: Service Class Specifications, 
copyright 2011, IBR approved for Appendix A to part 718, paragraph (d).
    (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, IBR approved for Appendix A to 
part 718, paragraph (d).
    (4) DICOM Standard PS 3.11-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 11: Media Storage Application 
Profiles, copyright 2011, IBR approved for Appendix A to part 718, 
paragraph (d).
    (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, IBR approved for Appendix A to 
part 718, paragraph (d).
    (6) DICOM Standard PS 3.14-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 14: Grayscale Standard Display 
Function, copyright 2011, IBR approved for Appendix A to part 718, 
paragraph (d).
    (7) DICOM Standard PS 3.16-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 16: Content Mapping Resource, 
copyright 2011, IBR approved for Appendix A to part 718, paragraph (d).


0
3. Revise Sec.  718.101(a) to read as follows:


Sec.  718.101  General.

    (a) The Office of Workers' Compensation Programs (hereinafter OWCP 
or the Office) must develop the medical evidence necessary to determine 
each claimant's entitlement to benefits. Each miner who files a claim 
for benefits under the Act must be provided an opportunity to 
substantiate his or her claim by means of a complete pulmonary 
evaluation including, but not limited to, a chest radiograph (X-ray), 
physical examination, pulmonary function tests, and a blood-gas study.
* * * * *

0
4. Revise Sec.  718.102 to read as follows:


Sec.  718.102  Chest radiographs (X-rays).

    (a) A chest radiograph (X-ray) must be of suitable quality for 
proper classification of pneumoconiosis and must conform to the 
standards for administration and interpretation of chest X-rays as 
described in appendix A to this part.
    (b) Chest X-rays may be produced by either film or digital 
radiography systems as defined in Appendix A.
    (c) The images described in paragraphs (c)(1) and (2) of this 
section will not be considered of suitable quality for proper 
classification of pneumoconiosis under this section:
    (1) Digital images derived from film screen chest X-rays (e.g., by 
scanning or digital photography); and
    (2) Images that were acquired using digital systems and then 
printed on transparencies for back-lighted display (e.g., using 
traditional view boxes).
    (d) Standards for classifying radiographs:
    (1) To establish the existence of pneumoconiosis, a film chest X-
ray must be classified as Category 1, 2, 3, A, B, or C, in accordance 
with the International Labour Organization (ILO) classification system 
established in one of the following:
    (i) Guidelines for the Use of the ILO International Classification 
of Radiographs of Pneumoconioses, revised edition 2011 (incorporated by 
reference, see Sec.  718.5).
    (ii) Guidelines for the Use of the ILO International Classification 
of Radiographs of Pneumoconioses, revised edition 2000 (incorporated by 
reference, see Sec.  718.5).
    (iii) Guidelines for the Use of ILO International Classification of 
Radiographs of Pneumoconioses, revised edition 1980 (incorporated by 
reference, see Sec.  718.5).
    (2) To establish the existence of pneumoconiosis, a digital chest 
radiograph must be classified as Category 1, 2, 3, A, B, or C, in 
accordance with the ILO classification system established in Guidelines 
for the Use of the ILO International Classification of Radiographs of 
Pneumoconioses, revised edition 2011.
    (3) A chest radiograph classified under any of the foregoing ILO 
classification systems as Category 0, including subcategories 0-, \0/
0\, or \0/1\, does not constitute evidence of pneumoconiosis.
    (e) An X-ray report must include the following:
    (1) The name and qualifications of the person who took the X-ray.
    (2) The name and qualifications of the physician who interpreted 
the X-ray. The interpreting physician must indicate whether he or she 
was a Board-certified radiologist, a Board-eligible radiologist, or a 
Certified B Reader as defined below on the date the interpretation was 
made.
    (i) Board-certified radiologist means that the physician is 
certified in radiology or diagnostic radiology by the American Board of 
Radiology, Inc., or the American Osteopathic Association.
    (ii) Board-eligible radiologist means that the physician has 
successfully completed a formal accredited residency program in 
radiology or diagnostic radiology.
    (iii) Certified B Reader means that the physician has demonstrated 
ongoing 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 by taking and passing 
a specially designed proficiency examination given on behalf of or by 
the National Institute for Occupational Safety and Health (NIOSH), and 
has maintained that certification through the date the interpretation 
is made. See 42 CFR 37.52(b).
    (3) A description and interpretation of the findings in terms of 
the ILO classification described in paragraph (d) of this section.
    (4) A statement that the X-ray was interpreted in compliance with 
this section.
    (f) Radiograph submission: For film X-rays, the original film on 
which the X-ray report is based must be supplied to OWCP. For digital 
X-rays, a copy of the original digital object upon which the X-ray 
report is based, formatted to meet the standards for transmission of 
diagnostic chest images set forth in Appendix A, paragraph (d), must be 
provided to OWCP on a DVD or other media specified by OWCP. In cases 
where the law prohibits the parties or a physician from supplying the 
original film or a copy of the digital image, the report will be 
considered as evidence only if the original film or digital image is 
otherwise available to OWCP and the other parties.
    (g) Where the chest X-ray of a deceased miner has been lost or 
destroyed, or is otherwise unavailable, a report of the chest X-ray 
submitted by any party may be considered in connection with the claim.

[[Page 35556]]

    (h) Except as provided in this paragraph (h), no chest X-ray may 
constitute evidence of the presence or absence of pneumoconiosis unless 
it is conducted and reported in accordance with the requirements of 
this section and Appendix A. In the absence of evidence to the 
contrary, compliance with the requirements of Appendix A must be 
presumed. In the case of a deceased miner where the only available X-
ray does not substantially comply with paragraphs (a) through (e) of 
this section, the X-ray may form the basis for a finding of the 
presence or absence of pneumoconiosis if it is of sufficient quality 
for determining whether pneumoconiosis is present and it was 
interpreted by a Board-certified radiologist, Board-eligible 
radiologist, or Certified B Reader.


0
5. Revise Sec.  718.202 to read as follows:


Sec.  718.202  Determining the existence of pneumoconiosis.

    (a) A finding of the existence of pneumoconiosis may be made as 
follows in paragraphs (a)(1) through (4):
    (1) A chest X-ray conducted and classified in accordance with Sec.  
718.102 may form the basis for a finding of the existence of 
pneumoconiosis. Except as otherwise provided in this section, where two 
or more X-ray reports are in conflict, in evaluating such X-ray reports 
consideration must be given to the radiological qualifications of the 
physicians interpreting such X-rays (see Sec.  718.102(d)).
    (2) A biopsy or autopsy conducted and reported in compliance with 
Sec.  718.106 may be the basis for a finding of the existence of 
pneumoconiosis. A finding in an autopsy or biopsy of anthracotic 
pigmentation, however, must not be considered sufficient, by itself, to 
establish the existence of pneumoconiosis. A report of autopsy must be 
accepted unless there is evidence that the report is not accurate or 
that the claim has been fraudulently represented.
    (3) If the presumptions described in Sec.  718.304, Sec.  718.305, 
or Sec.  718.306 are applicable, it must be presumed that the miner is 
or was suffering from pneumoconiosis.
    (4) A determination of the existence of pneumoconiosis may also be 
made if a physician, exercising sound medical judgment, notwithstanding 
a negative X-ray, finds that the miner suffers or suffered from 
pneumoconiosis as defined in Sec.  718.201. Any such finding must be 
based on objective medical evidence such as blood-gas studies, 
electrocardiograms, pulmonary function studies, physical performance 
tests, physical examination, and medical and work histories. Such a 
finding must be supported by a reasoned medical opinion.
    (b) A claim for benefits must not be denied solely on the basis of 
a negative chest X-ray.
    (c) A determination of the existence of pneumoconiosis must not be 
made--
    (1) Solely on the basis of a living miner's statements or 
testimony; or
    (2) In a claim involving a deceased miner, solely on the basis of 
the affidavit(s) (or equivalent testimony) of the claimant and/or his 
or her dependents who would be eligible for augmentation of the 
claimant's benefits if the claim were approved.


0
6. Revise Sec.  718.304 to read as follows:


Sec.  718.304  Irrebuttable presumption of total disability or death 
due to pneumoconiosis.

    There is an irrebuttable presumption that a miner is totally 
disabled due to pneumoconiosis, that a miner's death was due to 
pneumoconiosis or that a miner was totally disabled due to 
pneumoconiosis at the time of death, if such miner is suffering or 
suffered from a chronic dust disease of the lung which:
    (a) When diagnosed by chest X-ray (see Sec.  718.202 concerning the 
standards for X-rays and the effect of interpretations of X-rays by 
physicians) yields one or more large opacities (greater than one 
centimeter in diameter) and would be classified in Category A, B, or C 
in accordance with the classification system established in Guidelines 
for the Use of the ILO International Classification of Radiographs of 
Pneumoconioses as provided in Sec.  718.102(d); or
    (b) When diagnosed by biopsy or autopsy, yields massive lesions in 
the lung; or
    (c) When diagnosed by means other than those specified in 
paragraphs (a) and (b) of this section, would be a condition which 
could reasonably be expected to yield the results described in 
paragraph (a) or (b) of this section had diagnosis been made as therein 
described: Provided, however, that any diagnosis made under this 
paragraph must accord with acceptable medical procedures.


0
7. Revise appendix A to part 718 to read as follows:

Appendix A to Part 718--Standards for Administration and Interpretation 
of Chest Radiographs (X-rays)

    The following standards are established in accordance with 
sections 402(f)(1)(D) and 413(b) of the Act. They were developed in 
consultation with the National Institute for Occupational Safety and 
Health (NIOSH) of the Centers for Disease Control and Prevention in 
the Department of Health and Human Services. These standards are 
promulgated for the guidance of physicians and medical technicians 
to ensure that uniform procedures are used in administering and 
interpreting X-rays and that the best available medical evidence 
will be submitted in connection with a claim for black lung 
benefits. If it is established that one or more standards have not 
been met, the claims adjudicator may consider such fact in 
determining the evidentiary weight to be assigned to the physician's 
report of an X-ray.
    (a) Definitions
    (1) Digital radiography systems, as used in this context, 
include both digital radiography (DR) and computed radiography (CR). 
Digital radiography is the term used for digital X-ray image 
acquisition systems in which the X-ray signals received by the image 
detector are converted nearly instantaneously to electronic signals 
without moveable cassettes. Computed radiography is the term for 
digital X-ray image acquisition systems that detect X-ray signals 
using a cassette-based photostimulable storage phosphor. 
Subsequently, the cassette is processed using a stimulating laser 
beam to convert the latent radiographic image to electronic signals 
which are then processed and stored so they can be displayed.
    (2) Qualified medical physicist means an individual who is 
trained in evaluating the performance of radiographic equipment 
including radiation controls and facility quality assurance 
programs, and has the relevant current certification by a competent 
U.S. national board, or unrestricted license or approval from a U.S. 
State or Territory.
    (3) Radiographic technique chart means a table that specifies 
the types of cassette, intensifying screen, film or digital 
detector, grid, filter, and lists X-ray machine settings (timing, 
kVp, mA) that enables the radiographer to select the correct 
settings based on the body habitus or the thickness of the chest 
tissue.
    (4) Radiologic technologist means an individual who has met the 
requirements for privileges to perform general radiographic 
procedures and for competence in using the equipment and software 
employed by the examining facility to obtain chest images as 
specified by the State or Territory and examining facility in which 
such services are provided. Optimally, such an individual will have 
completed a formal training program in radiography leading to a 
certificate, an associate's 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.
    (5) Soft copy means the image of a coal miner's chest radiograph 
acquired using a digital radiography system, viewed at the full 
resolution of the image acquisition system using an electronic 
medical image display device.
    (b) General provisions
    (1) Facilities must maintain ongoing licensure and certification 
under relevant local, State, and Federal laws and regulations

[[Page 35557]]

for all digital equipment and related processes covered by this 
Appendix. Radiographic equipment, its use and the facilities 
(including mobile facilities) in which such equipment is used must 
conform to applicable State or Territorial and Federal regulations. 
Where no applicable regulations exist regarding reducing the risk 
from ionizing radiation exposure in the clinical setting, 
radiographic equipment, its use and the facilities (including mobile 
facilities) in which such equipment is used should conform to the 
recommendations in NCRP Report No. 102, NCRP Report No. 105, and 
NCRP Report No. 147 (incorporated by reference, see Sec.  718.5).
    (2) Chest radiographs of miners must be performed:
    (i) 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
    (ii) By a radiologic technologist.
    (3) Miners must be disrobed from the waist up at the time the 
radiograph is given. The facility must provide a dressing area and 
for those miners who wish to use one, the facility will provide a 
clean gown. Facilities must be heated to a comfortable temperature.
    (4) Before the miner is advised that the examination is 
concluded, the radiograph must be processed and inspected and 
accepted for quality standards by the physician, or if the physician 
is not available, acceptance may be made by the radiologic 
technologist. In a case of a substandard radiograph, another must be 
made immediately.
    (c) Chest radiograph specifications--film.
    (1) Every chest radiograph must be a single posteroanterior 
projection at full inspiration on a film being no less than 14 by 17 
inch film. Additional chest films or views must be obtained if they 
are necessary for clarification and classification. The film and 
cassette must be capable of being positioned both vertically and 
horizontally so that the chest radiograph will include both apices 
and costophrenic angles. If a miner is too large to permit the above 
requirements, then a projection with minimum loss of costophrenic 
angle must be made.
    (2) Radiographs must be made with a diagnostic X-ray machine 
having a rotating anode tube with a maximum of a 2 mm source (focal 
spot).
    (3) Except as provided in paragraph (c)(4), radiographs must be 
made with units having generators that comply with the following:
    (i) Generators of existing radiographic units acquired by the 
examining facility prior to July 27, 1973, must have a minimum 
rating of 200 mA at 100 kVp;
    (ii) Generators of units acquired subsequent to that date must 
have a minimum rating of 300 mA at 125 kVp. A generator with a 
rating of 150 kVp is recommended.
    (4) Radiographs made with battery-powered mobile or portable 
equipment must be made with units having a minimum rating of 100 mA 
at 110 kVp at 500 Hz, or 200 mA at 110 kVp at 60 Hz.
    (5) Capacitor discharge and field emission units may be used.
    (6) Radiographs must be given only with equipment having a beam-
limiting device that does not cause large unexposed boundaries. The 
use of such a device must be discernible from an examination of the 
radiograph.
    (7) To ensure high quality chest radiographs:
    (i) The maximum exposure time must not exceed 50 milliseconds 
except that with single phase units with a rating less than 300 mA 
at 125 kVp and subjects with chests over 28 cm postero-anterior, the 
exposure may be increased to not more than 100 milliseconds;
    (ii) The source or focal spot to film distance must be at least 
6 feet.
    (iii) Medium-speed film and medium-speed intensifying screens 
are recommended. However, any film-screen combination, the rated 
``speed'' of which is at least 100 and does not exceed 300, which 
produces radiographs with spatial resolution, contrast, latitude and 
quantum mottle similar to those of systems designated as ``medium 
speed'' may be employed;
    (iv) Film-screen contact must be maintained and verified at 6-
month or shorter intervals.
    (v) Intensifying screens must be inspected at least once a month 
and cleaned when necessary by the method recommended by the 
manufacturer;
    (vi) All intensifying screens in a cassette must be of the same 
type and made by the same manufacturer;
    (vii) When using over 90 kV, a suitable grid or other means of 
reducing scattered radiation must be used;
    (viii) The geometry of the radiographic system must ensure that 
the central axis (ray) of the primary beam is perpendicular to the 
plane of the film surface and impinges on the center of the film.
    (8) Radiographic processing:
    (i) Either automatic or manual film processing is acceptable. A 
constant time-temperature technique must be meticulously employed 
for manual processing.
    (ii) If mineral or other impurities in the processing water 
introduce difficulty in obtaining a high-quality radiograph, a 
suitable filter or purification system must be used.
    (9) An electric power supply must be used that complies with the 
voltage, current, and regulation specified by the manufacturer of 
the machine.
    (10) A test object may be required on each radiograph for an 
objective evaluation of film quality at the discretion of the 
Department of Labor.
    (11) Each radiograph made under this Appendix must be 
permanently and legibly marked with the name and address of the 
facility at which it is made, the miner's DOL claim number, the date 
of the radiograph, and left and right side of the film. No other 
identifying markings may be recorded on the radiograph.
    (d) Chest radiograph specifications--digital radiography systems
    (1) Every digital chest radiograph must be a single 
posteroanterior projection at full inspiration on a digital detector 
with sensor area being no less than 1505 square centimeters with a 
minimum width of 35 cm. The imaging plate must have a maximum pixel 
pitch of 200 [micro]m, with a minimum bit depth of 10. Spatial 
resolution must be at least 2.5 line pairs per millimeter. The 
storage phosphor cassette or digital image detector must be 
positioned either vertically or horizontally so that the image 
includes the apices and costophrenic angles of both right and left 
lungs. If the detector cannot include the apices and costophrenic 
angles of both lungs as described, then the two side-by-side images 
can be obtained that together include the apices and costophrenic 
angles of both right and left lungs.
    (2) Radiographs must be made with a diagnostic X-ray machine 
with a maximum actual (not nominal) source (focal spot) of 2 mm, as 
measured in two orthogonal directions.
    (3) Radiographs must be made with units having generators which 
have a minimum rating of 300 mA at 125 kVp. Exposure kilovoltage 
must be at least the minimum as recommended by the manufacturer for 
chest radiography.
    (4) An electric power supply must be used that complies with the 
voltage, current, and regulation specified by the manufacturer of 
the machine. If the manufacturer or installer of the radiographic 
equipment recommends equipment for control of electrical power 
fluctuations, such equipment must be used as recommended.
    (5) Radiographs must be obtained only with equipment having a 
beam-limiting device that does not cause large unexposed boundaries. 
The beam limiting device must provide rectangular collimation. 
Electronic post-image acquisition ``shutters'' available on some CR 
or DR systems that limit the size of the final image and that 
simulate collimator limits must not be used. The use and effect of 
the beam limiting device must be discernible on the resulting image.
    (6) Radiographic technique charts must be used that are 
developed specifically for the X-ray system and detector 
combinations used, indicating exposure parameters by anatomic 
measurements.
    (7) To ensure high quality chest radiographs:
    (i) The maximum exposure time must not exceed 50 milliseconds 
except for subjects with chests over 28 cm posteroanterior, for whom 
the exposure time must not exceed 100 milliseconds.
    (ii) The distance from source or focal spot to detector must be 
at least 70 inches (or 180 centimeters if measured in centimeters).
    (iii) The exposure setting for chest images must be within the 
range of 100-300 equivalent exposure speeds and must comply with ACR 
Practice Guidelines for Diagnostic Reference Levels in Medical X-ray 
Imaging, Section V--Diagnostic Reference Levels for Imaging with 
Ionizing Radiation and Section VII--Radiation Safety in Imaging 
(incorporated by reference, see Sec.  718.5). Radiation exposures 
should be periodically measured and patient radiation doses 
estimated by the medical physicist to assure doses are as low as 
reasonably achievable.
    (iv) Digital radiography system performance, including 
resolution, modulation transfer function (MTF), image signal-to-
noise and detective quantum

[[Page 35558]]

efficiency must be evaluated and judged acceptable by a qualified 
medical physicist using the specifications in AAPM Report No. 93, 
pages 1-68 (incorporated by reference, see Sec.  718.5). Image 
management software and settings for routine chest imaging must be 
used, including routine amplification of digital detector signal as 
well as standard image post-processing functions. Image or edge 
enhancement software functions must not be employed unless they are 
integral to the digital radiography system (not elective); in such 
cases, only the minimum image enhancement permitted by the system 
may be employed.
    (v)(A) The image object, transmission and associated data 
storage, film format, and transmissions of associated information 
must conform to the following components of the Digital Imaging and 
Communications in Medicine (DICOM) standard (incorporated by 
reference, see Sec.  718.5):
    (1) DICOM Standard PS 3.3-2011, Annex A--Composite Information 
Object Definitions, sections: Computed Radiographic Image 
Information Object Definition; Digital X-Ray Image Information 
Object Definition; X-Ray Radiation Dose SR Information Object 
Definition; and Grayscale Softcopy Presentation State Information 
Object Definition.
    (2) DICOM Standard PS 3.4-2011: Annex B--Storage Service Class; 
Annex N--Softcopy Presentation State Storage SOP Classes; Annex O--
Structured Reporting Storage SOP Classes.
    (3) DICOM Standard PS 3.10-2011.
    (4) DICOM Standard PS 3.11-2011.
    (5) DICOM Standard PS 3.12-2011.
    (6) DICOM Standard PS 13.14-2011.
    (7) DICOM Standard PS 3.16-2011.
    (B) Identification of each miner, chest image, facility, date 
and time of the examination must be encoded within the image 
information object, according to DICOM Standard PS 3.3-2011, 
Information Object Definitions, for the DICOM ``DX'' object. If data 
compression is performed, it must be lossless. Exposure parameters 
(kVp, mA, time, beam filtration, scatter reduction, radiation 
exposure) must be stored in the DX information object.
    (C) Exposure parameters as defined in the DICOM Standard PS 
3.16-2011 must additionally be provided when such parameters are 
available from the facility digital image acquisition system or 
recorded in a written report or electronic file and transmitted to 
OWCP.
    (8) A specific test object may be required on each radiograph 
for an objective evaluation of image quality at the Department of 
Labor's discretion.
    (9) CR imaging plates must be inspected at least once a month 
and cleaned when necessary by the method recommended by the 
manufacturer.
    (10) A grid or air gap for reducing scattered radiation must be 
used; grids must not be used that cause Moir[eacute] interference 
patterns in either horizontal or vertical images.
    (11) The geometry of the radiographic system must ensure that 
the central axis (ray) of the primary beam is perpendicular to the 
plane of the CR imaging plate or DR detector and is correctly 
aligned to the grid.
    (12) Radiographs must not be made when the environmental 
temperatures and humidity in the facility are outside the 
manufacturer's recommended range of the CR and DR equipment to be 
used.
    (13) All interpreters, whenever classifying digitally acquired 
chest radiographs, must have immediately available for reference a 
complete set of ILO standard digital chest radiographic images 
provided for use with the Guidelines for the Use of the ILO 
International Classification of Radiographs of Pneumoconioses (2011 
Revision) (incorporated by reference, see Sec.  718.5). Modification 
of the appearance of the standard images using software tools is not 
permitted.
    (14) 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 ILO standard images for 
comparison.
    (i)(A) 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.  
718.5).
    (B) 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.  718.5).
    (ii) 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.  
718.5). Viewing displays must have a maximum luminance of at least 
171 cd/m\2\, a ratio of maximum luminance to minimum luminance of at 
least 250, and a glare ratio greater than 400. The contribution of 
ambient light reflected from the display surface, after light 
sources have been minimized, must be included in luminance 
measurements.
    (iii) Displays must be situated so as to minimize front surface 
glare. Readers must minimize reflected light from ambient sources 
during the performance of classifications.
    (iv) 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.
    (15) 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.  
718.5). 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.
    (16) Classification of CR and DR digitally-acquired chest 
radiographs under this Part must be performed based on the viewing 
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.
    (17) The classification of chest radiographs based on digitized 
copies of chest radiographs that were originally acquired using 
film-screen techniques is not permissible.

PART 725--CLAIMS FOR BENEFITS UNDER PART C OF TITLE IV OF THE 
FEDERAL MINE SAFETY AND HEALTH ACT, AS AMENDED

0
8. The authority citation for part 725 is revised to read as follows:

    Authority: 5 U.S.C. 301; Reorganization Plan No. 6 of 1950, 15 
FR 3174; 30 U.S.C. 901 et seq., 902(f), 921, 932, 936; 33 U.S.C. 901 
et seq.; 42 U.S.C. 405; Secretary's Order 10-2009, 74 FR 58834.


0
9. In Sec.  725.406, revise paragraphs (a), (b), (c) and (e) to read as 
follows:


Sec.  725.406  Medical examinations and tests.

    (a) The Act requires the Department to provide each miner who 
applies for benefits with the opportunity to undergo a complete 
pulmonary evaluation at no expense to the miner. A complete pulmonary 
evaluation includes a report of physical examination, a pulmonary 
function study, a chest radiograph, and, unless medically 
contraindicated, a blood gas study.
    (b) As soon as possible after a miner files an application for 
benefits, the district director will provide the miner with a list of 
medical facilities and physicians in the state of the miner's residence 
and states contiguous to the state of the miner's residence that the 
Office has authorized to perform complete pulmonary evaluations. The 
miner must select one of the facilities or physicians on the list, 
provided that the miner may not select any physician to whom the miner 
or the miner's spouse is related to the fourth degree of consanguinity, 
and the miner may not select any physician who has examined or provided 
medical treatment to the miner within the twelve months preceding the 
date of the miner's application. The district director will make 
arrangements for the miner to be given a complete pulmonary evaluation 
by that facility or physician. The results of the complete pulmonary 
evaluation must not be counted as evidence submitted by the miner under 
Sec.  725.414.

[[Page 35559]]

    (c) If any medical examination or test conducted under paragraph 
(a) of this section is not administered or reported in substantial 
compliance with the provisions of part 718 of this subchapter, or does 
not provide sufficient information to allow the district director to 
decide whether the miner is eligible for benefits, the district 
director must schedule the miner for further examination and testing. 
Where the deficiencies in the report are the result of a lack of effort 
on the part of the miner, the miner will be afforded one additional 
opportunity to produce a satisfactory result. In order to determine 
whether any medical examination or test was administered and reported 
in substantial compliance with the provisions of part 718 of this 
subchapter, the district director may have any component of such 
examination or test reviewed by a physician selected by the district 
director.
* * * * *
    (e) The cost of any medical examination or test authorized under 
this section, including the cost of travel to and from the examination, 
must be paid by the fund. Reimbursement for overnight accommodations 
must not be authorized unless the district director determines that an 
adequate testing facility is unavailable within one day's round trip 
travel by automobile from the miner's residence. The fund must be 
reimbursed for such payments by an operator, if any, found liable for 
the payment of benefits to the claimant. If an operator fails to repay 
such expenses, with interest, upon request of the Office, the entire 
amount may be collected in an action brought under section 424 of the 
Act and Sec.  725.603 of this part.

    Signed at Washington, DC, this 3rd day of June, 2013.
Gary A. Steinberg,
Acting Director, Office of Workers' Compensation Programs.
[FR Doc. 2013-13970 Filed 6-12-13; 8:45 am]
BILLING CODE 4510-CR-P