Black Lung Benefits Act: Standards for Chest Radiographs, 21606-21615 [2014-08636]

Agencies

• DEPARTMENT OF LABOR
• Office of Workers' Compensation Programs

[Federal Register Volume 79, Number 74 (Thursday, April 17, 2014)]
[Rules and Regulations]
[Pages 21606-21615]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08636]


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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: Final rule.

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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 administering and interpreting film-based chest 
radiographs. This final rule updates the Department's existing film-
radiograph standards and provides parallel standards for digital 
radiographs. This rule also updates outdated terminology and removes 
certain obsolete provisions.

DATES: This rule is effective May 19, 2014. The incorporation by 
reference of certain publications listed in the rule is approved by the 
Director of the Federal Register as of May 19, 2014.

FOR FURTHER INFORMATION CONTACT: Gerald Delo, Deputy Director, Division 
of Coal Mine Workers' Compensation, Office of Workers' Compensation 
Programs, U.S. Department of Labor, 200 Constitution Avenue NW., Suite 
C-3520, Washington, DC 20210. Telephone: (202) 343-5907 (this is not a 
toll-free number). TTY/TDD callers may dial toll-free 1-800-877-8339 
for further information.

SUPPLEMENTARY INFORMATION:

I. Background of This Rulemaking

    On June 13, 2013, the Office of Workers' Compensation Programs 
(OWCP) published a direct final rule (78 FR 35549) and a companion 
notice of proposed rulemaking (NPRM) (78 FR 35575) to update the 
existing quality standards for administering and interpreting film-
based chest radiographs and to add parallel standards for digital 
radiographs for claims under the Black Lung Benefits Act (BLBA), 30 
U.S.C. 901-944. Both documents stated that if OWCP received significant 
adverse comment, the direct final rule would be withdrawn. OWCP asked 
for comments on all issues related to the rule, including economic or 
other regulatory impacts on the regulated community. Because OWCP 
received significant adverse comment, OWCP withdrew the direct final 
rule on August 30, 2013, 78 FR 53645. This final rule completes the 
process begun by the notice of proposed rulemaking.
    As explained in the NPRM, OWCP proposed adding digital radiography 
standards to the existing standards

[[Page 21607]]

because digital radiography systems are rapidly replacing traditional 
analog film-based systems in medical facilities. 78 FR 35576-35577. 
Because of this technology shift, claimants, coal mine operators, and 
the Department had been experiencing increasing difficulty in obtaining 
film chest X-rays of miners. Although interpretations of digital X-rays 
were admissible as ``other medical evidence'' under the catch-all 
provision at 20 CFR 718.107, the interpretation's proponent had to 
establish 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) aff'd on recon., 24 BLR 1-1 (2007) (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 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.
    This final rule fills the technological gap with regulatory quality 
standards for digital radiographs. As it did when it first promulgated 
quality standards for film-based chest X-rays, see 78 FR 35576-35577 
(summarizing history of X-ray quality standards and Department's 
authority to adopt them), the Department has based the standards 
adopted in this final rule largely on those promulgated in 2012 by the 
Department of Health and Human Services for use in the National 
Institute for Occupational Safety and Health (NIOSH) Coal Workers' 
Health Surveillance Program (CWHSP) (the NIOSH rules). See 42 CFR 37.1 
et seq.; see also 77 FR 56718-56735 (September 13, 2012) (NIOSH final 
rule); 77 FR 1360-1385 (January 9, 2012) (NIOSH proposed rule). Under 
the CWHSP, NIOSH approves medical facilities for participation in 
monitoring the health of the nation's coal miners through periodic 
chest X-ray screening. See 42 CFR 37.44-37.45; see also 78 FR 35577 
(discussing the CWHSP). Congress designated NIOSH as the Department's 
statutory advisor for establishing standards for BLBA medical testing. 
30 U.S.C. 902(f)(1)(D).
    The standards adopted here 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 final rule also retains 
the current regulatory quality standards for film-based chest X-rays 
with the minor terminology modifications explained in the NPRM. See 78 
FR 35579. The final rule 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.

II. 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).

III. Discussion of Comments

    The Department received comments from only three sources: The 
American College of Radiology (ACR), a coal mine operator, and an 
insurance company that insures coal mine operators for BLBA 
liabilities. The latter two submissions (industry comments) were 
identical in all substantive respects. While the commenters commend the 
Department for moving forward with digital radiograph standards, they 
also criticize the proposed rules. Their comments pertain primarily to 
very limited portions of Sec.  718.102 and Part 718, Appendix A. The 
Department had proposed substantially revising these regulations to 
allow parties the option of submitting X-rays that are produced either 
by film or digital radiography systems. The Department explained in 
detail each of the proposed revisions, deletions, and additions in the 
NPRM. See 78 FR 35577-79.
    The Department has considered the comments received but declines to 
revise the proposed rule for the reasons set forth in this section. In 
reaching this conclusion, the Department consulted extensively with 
NIOSH, and NIOSH has reviewed this final rule. The Department's 
response to cost-related comments is set forth below in the section on 
Executive Orders 12866 and 13563.

20 CFR 718.102(c) and Part 718 Appendix A, Paragraph (d)(16): Converted 
Radiographs

    Section 718.102(c) and paragraph (d)(16) of Appendix A, as 
proposed, prohibit the use of interpretations of X-rays that have been 
converted from digital to film, or vice-versa. The Department proposed 
the limitation because NIOSH had determined that these ``converted'' 
radiographs do not assure similar results to that obtained from film 
under the existing standards. See 78 FR 35578.
    The ACR and the industry comments ask the Department to remove this 
provision from the regulation. Acknowledging that converted images are 
not ideal, the ACR states that they nevertheless can be adequate for 
interpretation. The industry comments claim that using converted images 
is a common practice and that disallowing their use is inconsistent 
with the Guidelines for the Use of ILO International Classification of 
Radiographs of Pneumoconiosis, 2011 edition. Both the ACR and the 
industry argue that determining whether any particular converted image 
is of sufficient quality and suitable for classification under the ILO 
Guidelines should be left to a qualified B-reader's discretion.
    All parties recognize the importance of valid, accurate medical 
evidence in claims adjudications. In promulgating these rules, the 
Department is expanding accessibility to medical providers by 
permitting the use of digitally acquired images. But it must still 
assure that decisions regarding a miner's physical condition do not 
vary depending on the radiographic technology used for evaluations.
    A primary difficulty with using converted images is that, at the 
current time, the Department is unaware of specifications for 
equipment, procedures, and methods that can assure the accuracy and 
precision of converted images when used for ILO classification 
purposes. In fact, the available scientific evidence casts doubt on the 
accuracy of some converted images. Studies of digital images converted 
to film showed that the apparent profusion of small opacities was 
greater on printed hard copies of digital images than on either 
digitally acquired radiographs displayed on a monitor or analog film-
based radiographs obtained at the same time. Franzblau A, Kazerooni EA, 
Sen A, Goodsitt MM, Lee SY, Rosenman KD, Lockey JE, Meyer CA, Gillespie 
BW, Petsonk EL, Wang ML [2009], Comparison of digital radiographs with

[[Page 21608]]

film radiographs for the classification of pneumoconiosis, Acad Radiol 
16(6):669-677. See also 78 FR 35578 citing 77 FR 1366 (NIOSH discussion 
of scientific studies). Moreover, there is no standardized approach to 
the process of creating the hard copy or for the equipment used to do 
so.
    The Department also lacks data about the accuracy of scanned, 
digitized images obtained from analog chest radiographs when used for 
ILO classification purposes. Theoretically, available image receptors 
for digital radiography systems can detect a depth of gray scale that 
is considerably greater than for analog photographic film, and the 
additional gray scale is not available when analog images are scanned 
to digital. Signal processing after digital image acquisition also 
generally improves the visualization of structures that might not be 
visible on an analog film image, for example those overlying the 
mediastinum and heart. This post-processing cannot generally be done 
when analog images are digitized. Another barrier to using scanned, 
digitized versions of analog images is the absence of an industry-wide 
standard for the digitizing process that is documented to provide image 
characteristics that are relatively uniform and acceptable for 
pneumoconiosis classification. Specifications, operation, and 
maintenance of the scanning equipment used to digitize images can all 
affect the quality of the resulting image.
    The industry comments state that disallowing converted radiographs 
is contrary to the ILO Guidelines and that the ILO itself converted its 
standard film radiographs to create standardized digital images for use 
with the ILO classification system. While the ILO Guidelines do not 
prohibit application of the classification system to converted 
radiographs, the Guidelines are necessarily broad because they are used 
worldwide, including countries where the industry has strict standards 
for conversion processes and the associated hardware (e.g., printers 
and scanners). In fact, the ILO's experience in digitizing its standard 
analog films highlights the problems with the digital conversion 
process and the difficulty of preserving the integrity of 
pneumoconiotic findings during that process. It is a highly subjective 
process that is not easily routinized; multiple iterations and software 
manipulations were required to provide images with characteristics that 
the ILO experts felt adequately reflected their original standard 
films. These labor-intensive efforts are simply not a normal part of 
current clinical practice in the United States, and it is unlikely a 
clinician would go to such extraordinary lengths to ensure accurate 
conversion of an individual miner's radiographs. Although the ACR 
comment asserts that existing technology can display excellent analog 
images converted from digitally-acquired images, it does not include 
any details or other information on that technology for the Department 
to consider.
    The Department also does not agree that detection of quality 
problems in the conversion process should be left to certified B 
readers for several reasons. First, even assuming a B-reader could 
detect quality problems, parties are not required to submit 
interpretations made by B-readers or physicians who specialize in 
radiology. Readings made by the miner's treating physician or 
pulmonologist are often offered as evidence, even when these physicians 
are not certified B-readers. Thus, it is important that the radiographs 
themselves are consistently high-quality for all interpreting 
physicians. Second, the Department is not confident that a B-reader 
could reliably detect quality deficiencies such as data loss from the 
converted image alone, and the Department is unaware of any scientific 
studies suggesting otherwise. Finally, leaving the validity of 
converted radiographs to resolution on a claim-by-claim, radiograph-by-
radiograph basis would generate additional litigation in BLBA claims. 
The quality standards are designed to avoid such a result.
    In sum, the Department is unaware of any scientific evidence 
supporting the use of converted radiographs for pneumoconiosis 
classification, and the comments point to none. The Department intends 
to monitor the scientific literature, and will consider further 
modification of the rule if additional evidence becomes available 
regarding specific methods of converting images between analog and 
digital formats, and the equivalence of ILO classifications of such 
converted images.
    The commenters suggest two alternatives to banning converted 
radiographs. First, they ask the Department to allow interpretations of 
converted images to be submitted under Sec.  718.107, which permits 
submission of ``any medically acceptable test or procedure reported by 
a physician and not addressed in this subpart[.]'' 20 CFR 718.107(a) 
(emphasis added). The submitting party must demonstrate the medical 
acceptability of the test or procedure and its relevance to the claim's 
adjudication. 20 CFR 718.107(b). Section 718.107 is a flexible catch-
all provision for admitting existing or future types of testing not 
specifically addressed by the regulatory quality standards at 20 CFR 
718.101-718.106 (standards for chest X-rays, pulmonary function tests, 
reports of physical examinations, arterial blood gas studies, and 
autopsy and biopsy evidence). For instance, parties may submit chest 
computed tomography (CT) scan results under Sec.  718.107 if the 
submitter satisfies the adjudicator as to its reliability and relevance 
because the Department has not established quality standards for that 
particular test. Likewise, prior to this final rule's promulgation, 
parties could submit interpretations based on digital chest radiographs 
under Sec.  718.107 because the Department had not addressed that 
particular technology. See, e.g., Harris v. Old Ben Coal Co., 23 BLR 1-
98 (2006) (en banc), aff'd on recon., 24 BLR 1-13 (2007) (en banc). 
Because the final rule now provides standards for digital radiographs, 
Sec.  718.107's catch-all provision, by its plain language, no longer 
applies. Instead, the new rule embodies the Department's determination 
of what digital radiographs (and their interpretations) are medically 
acceptable for purposes of adjudicating BLBA claims. This relieves 
parties of the burden of proving medical acceptability in each case and 
sets a quality threshold for digital radiographic evidence used for 
entitlement determinations. To accept the commenter's suggestion and 
allow submission of digital radiographs under Sec.  718.107 that do not 
meet the new criteria would effectively create a loophole that negates 
the very purpose of those criteria.
    Second, the commenters ask the Department to delay the effective 
date of Sec.  718.102(c) and Appendix A, paragraph (d)(16) for 2 to 3 
years so that medical facilities and state regulatory bodies have time 
to comply with the rule. In support, the ACR states that some 
facilities may not have a system that allows for digital image 
transmission and that they should be allowed time to modernize their 
equipment to comply with the new standards. The ACR also notes at least 
one state requires film radiographs for workers' compensation 
evaluations and that it is unclear whether legal entities involved in 
state workers' compensation claims have the ability to display digital 
images on medical-grade monitors.
    The Department does not agree that delaying the effective date of 
Sec.  718.102(c) is necessary. While some facilities may not yet have 
acquired the equipment necessary to meet the final rule's requirements, 
many have. In 2011, prior to NIOSH's promulgation of

[[Page 21609]]

its digital radiography regulations, approximately sixty-one analog 
film facilities were approved to participate in the CWHSP. After NIOSH 
adopted digital radiography standards in 2012, the total number of 
NIOSH-approved facilities rose to ninety in 2013, with forty-two of 
these facilities approved to perform digital radiographs. This dramatic 
growth in the number of NIOSH-approved facilities would not have 
occurred so quickly if facilities either did not already have the 
capacity or could not easily acquire it to perform digital radiographs 
in compliance with the standards adopted in this final rule. More 
importantly, the regulations do not force any party to use digital 
radiography systems; the traditional analog film option remains 
available. Thus, if a state requires film radiographs, interpretations 
of those films will also be admissible in BLBA claims, provided the X-
rays were administered and interpreted in compliance with the analog-
film standards set forth in Sec.  718.102 and Appendix A.

Part 718 Appendix A, Paragraph (d)(14): Software Availability for 
Interpreting Digital Radiographs

    The industry comments state that no commercial picture archiving 
and communications system (PACS) vendors provide software that allows 
side-by-side display of the miner's radiograph with the ILO standard 
digital images. This method of interpreting digital radiographs is set 
forth in proposed Part 718 Appendix A, paragraph (d)(14). Although 
software availability is limited, facilities seeking to provide this 
service are not without options. Facilities can use the NIOSH BViewer 
software, which is offered free to the public and available on NIOSH's 
Web site. Facilities can also work with their PACS vendor to adapt 
existing software, utilize the BViewer software, or develop other 
innovative solutions. Indeed, at least one PACS provider has given 
NIOSH a software supplement that permits chest image classifications to 
be performed side-by-side with the ILO standard digital images on its 
commercially available system. The Department believes the availability 
of chest image classification software will increase as more of the 
industry utilizes digital systems. Moreover, limited software 
availability should not forestall the Department from adopting a rule 
for classifying digital radiographs for use by those facilities that 
currently have the capacity to meet the quality standards. Accordingly, 
no change has been made in response to this comment.

Remaining Provisions

    No comments were received on several proposed provisions--Sec.  
718.5 (incorporations by reference), Sec.  718.202 (determining the 
existence of pneumoconiosis), and Sec.  718.304 (Irrebuttable 
presumption of total disability or death due to pneumoconiosis). These 
regulations are therefore promulgated in this final rule as proposed 
with one technical revision to Sec.  718.202(a)(3). As proposed, 
section 718.202(a)(3) included a cross-reference to Sec.  718.306. 78 
FR 35582. After the proposal was published, however, the Department 
promulgated a final rule revising Sec.  718.202(a)(3) to remove the 
cross-reference because the Department had ceased publication of Sec.  
718.306. 78 FR 39114 (September 25, 2013). This final rule conforms 
Sec.  718.202(a)(3) to the intervening September 25, 2013 final rule.

IV. Administrative Law Considerations

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

    In the NPRM, the Department stated that the proposed rules did not 
impose any new information collections under the Paperwork Reduction 
Act, 44 U.S.C. 3501 et seq. 78 FR 35579. The final rule at Sec.  
718.102(f) requires physicians obtaining radiographs of miners on 
digital radiography systems to submit the radiograph in electronic 
format, rather than analog film format. The Department is incorporating 
this format change into an existing approved information collection 
titled ``Claim Adjudication Process for Alleged Presence of 
Pneumoconiosis,'' OMB Control Number 1240-0023. Although the Department 
does not believe this is a new information collection, changes the 
actual data collected, or alters the estimated information collection 
(paperwork) burdens imposed on the public, the additional electronic 
format option could be considered a change to an existing information 
collection currently approved under the PRA.
    Accordingly, the Department published a notice in the Federal 
Register on November 19, 2013, 78 FR 69449, requesting comments from 
the public on revising the collection to include information in 
electronic format. The notice directed the public to submit comments to 
the Office of Management and Budget (OMB) on or before December 19, 
2013. No comments were received. The Department also submitted a 
revised information collection request to OMB. OMB preapproved the 
revisions to the information collection on December 27, 2013. See 
https://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=1240-0023 (last visited Feb. 24, 2014).

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.
    The Department fully explained this conclusion in the NPRM (78 FR 
35579-80). The rule will increase access to radiographic technology, 
which in turn will increase the number of medical providers available 
to OWCP and reduce delays in processing miners' benefits claims; 
increase access for claimants and coal mine operators (and their 
insurers) to additional radiographic facilities; and relieve parties of 
the demanding evidentiary burden of proving medical acceptability of 
digital X-rays under Sec.  718.107. The Department also considered 
whether the parties will realize any monetary benefits or incur any 
additional costs in light of this rule, and concluded that it is a 
cost-neutral rule. The rule expands opportunities for claimants and 
coal mine employers to obtain X-ray evidence, but does not require any 
party to use digital X-ray systems; medical facilities generally charge 
the same fee for film and digital radiographs; and miners' reimbursable 
travel costs may decrease if miners have access to a digital facility 
in their locality.
    The industry comments state that the Department has underestimated 
the cost impact of the rule. They note that to comply with the 
requirements set forth in Part 718, Appendix A, medical facilities will 
need to obtain physics support, conduct annual testing of monitors, and 
purchase additional medical-grade monitors so that the X-ray 
interpreter can display the miner's digital radiograph side-by-side 
with the standard ILO-approved digital images when reading the 
radiograph. They believe these requirements will impose additional 
costs on medical facilities.

[[Page 21610]]

    In the context of this rulemaking, the Department's primary concern 
is the direct financial impact on parties to BLBA claims. Cf. Mid-Tex 
Elec. Coop., Inc. v. Fed. Energy Regulatory Comm'n, 773 F.2d 327, 343 
(D.C. Cir. 1985) (recognizing that ``Congress did not intend to require 
that every agency consider every indirect effect that any regulation 
might have on small businesses in any stratum of the national 
economy''). The comments neither suggest that the parties will incur 
higher costs to obtain digital radiographs than analog film radiographs 
nor disagree with the Department's analysis of that cost as set out in 
the NPRM. Thus, the Department continues to believe that the rule is 
cost-neutral for the parties in claim proceedings.
    Looking further downstream at potential costs imposed on medical 
facilities, the Department notes that any costs incurred for purchasing 
and maintaining digital radiography systems is at the facilities' 
option and is not required by these rules. The final rule continues to 
allow submission of traditional analog film radiographs. Thus, 
facilities may proceed as they have in the past with no change in cost 
burden.
    Facilities that choose to transition to a digital environment are 
already investing in the core hardware, software, and maintenance 
needed to perform digital radiography and evaluate digital images. As 
both the Department and NIOSH have noted, the burden imposed by these 
standards is low because they reflect standard industry practice and 
technology that digital-radiography facilities already follow. See 78 
FR 35579; 77 FR 56724 (September 13, 2012); 77 FR 1372 (January 9, 
2012). Although a particular facility might incur an added cost for 
purchasing an additional medical-grade monitor or computer processing 
unit so that images may be displayed side-by-side with the ILO standard 
images when interpreting them for pneumoconiosis--a requirement in both 
the NIOSH regulations and this final rule--the Department believes that 
many, if not most, radiography facilities already have this capacity. 
Notably, no member of the medical community commented on this 
requirement or raised cost-related concerns in response to either the 
NPRM or NIOSH's proposed rule.
    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 NPRM, this rule revises obsolete terms (e.g., 
replacing ``roentgenogram'' with ``radiograph'' or ``X-ray''), 
discontinues publication of obsolete provisions (e.g., the X-ray 
rereading prohibition provisions), and replaces the imprecise term 
``shall.'' 78 FR 35577-35578. Because the Department received no 
comment on these revisions, the affected regulations have been 
promulgated as proposed.
    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.
    For the reasons set forth in the NPRM, the Department determined 
that a complete regulatory flexibility analysis was not necessary, and 
certified that the proposed rules would not have a significant economic 
impact on a substantial number of small entities. 78 FR 35580. The 
Department invited public comment on the certification and delivered a 
copy of the certification to the Chief Counsel for Advocacy of the 
Small Business Administration. See generally 5 U.S.C. 605.
    The Chief Counsel for Advocacy has not filed comments on the 
certification. Although the industry comments state generally that 
medical facilities could incur additional costs under the new rule, 
these comments do not challenge the Department's stated factual basis 
for the certification: (1) Using digital radiography (and incurring 
associated additional costs, if any) is optional; (2) the costs for a 
party to obtain a film or digital radiograph are equivalent; and (3) 
the rule will benefit all parties by providing access to additional 
medical facilities. These comments also were not couched in terms of 
small business and made no allegation that the parties in claim 
proceedings would incur additional costs. See, e.g., United Distrb. 
Companies v. Fed. Energy Regulatory Comm'n, 88 F.3d 1105, 1170 (D.C. 
Cir. 1996) (holding that agency has ``no obligation to conduct a small 
entity impact analysis of effects on entities which it does not 
regulate''); Mid-Tex Elec. Coop., Inc., 773 F.2d at 343; see also White 
Eagle Coop. Ass'n v. Conner, 553 F.3d 467, 480 (7th Cir. 2009) (holding 
that milk producers did not have standing to bring challenge to 
regulation of milk market under the RFA where the regulation reached 
the producers only indirectly).
    Because the comments provide no basis for departing from its prior 
conclusion, the Department again certifies that this rule will not have 
a significant economic impact on a substantial number of small 
entities. As a result, no regulatory impact analysis is required.

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 final 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

[[Page 21611]]

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 https://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, https://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, https://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, 
https://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, https://www.ncrppublications.org:
    (1) NCRP Report No. 102, Medical X-Ray, Electron Beam, and Gamma-
Ray Protection for Energies Up to 50 MeV (Equipment Design, 
Performance, and Use), issued June 30, 1989, 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, 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, https://medical.nema.org:
    (1) DICOM Standard PS 3.3-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 3: Information Object Definitions, 
copyright 2011, IBR approved for Appendix A to part 718, paragraph (d).
    (2) DICOM Standard PS 3.4-2011, 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-

[[Page 21612]]

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.
    (b) Chest X-rays may be produced by either film or digital 
radiography systems as defined in Appendix A to this part.
    (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.
    (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) of this section:
    (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 or Sec.  718.305 
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

[[Page 21613]]

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 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) of this appendix, 
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.

[[Page 21614]]

    (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 [mu]m, with a minimum bit depth of 10. Spatial 
resolution must be at least 2.5 line pairs per millimeter. The 
storage phosphor cassette or digital image detector must be 
positioned either vertically or horizontally so that the image 
includes the apices and costophrenic angles of both right and left 
lungs. If the detector cannot include the apices and costophrenic 
angles of both lungs as described, then 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 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.

[[Page 21615]]

    (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.
    (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.

Gary A. Steinberg,
Acting Director, Office of Workers' Compensation Programs.
[FR Doc. 2014-08636 Filed 4-16-14; 8:45 am]
BILLING CODE 4510-CR-P