[Federal Register: December 20, 2000 (Volume 65, Number 245)]
[Rules and Regulations]
[Page 79919-79968]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20de00-16]
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Part II
Department of Labor
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Employment Standards Administration
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20 CFR Part 718 et al.
Regulations Implementing the Federal Coal Mine Health and Safety Act of
1969, as Amended; Final Rule
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DEPARTMENT OF LABOR
Employment Standards Administration
20 CFR Parts 718, 722, 725, 726, 727
RIN 1215-AA99
Regulations Implementing the Federal Coal Mine Health and Safety
Act of 1969, as Amended
AGENCY: Employment Standards Administration, Labor.
ACTION: Final rule.
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SUMMARY: On January 22, 1997, the Department issued a proposed rule to
amend the regulations implementing the Black Lung Benefits Act. 62 FR
3338-3435 (Jan. 22, 1997). When the comment period closed on August 21,
1997, the Department had received written submissions from almost 200
interested persons, including coal miners, coal mine operators,
insurers, physicians, and attorneys. The Department also held hearings
in Charleston, West Virginia, and Washington, D.C. at which over 50
people testified. The Department carefully reviewed the testimony and
the comments and, on October 8, 1999, issued a second notice of
proposed rulemaking. 64 FR 54966-55072 (Oct. 8, 1999). In its second
notice, the Department proposed changing several of the most important
provisions in its initial proposal. The Department also explained its
decision not to alter the original proposal with respect to other key
regulations based on the comments received to date. Finally, the
Department prepared an initial regulatory flexibility analysis. In
order to ensure that small businesses that could be affected by the
Department's proposal received appropriate notice of the Department's
proposed changes, the Department mailed a copy of the second notice of
proposed rulemaking to all coal mine operators contained in the
databases maintained by the Mine Safety and Health Administration.
The Department initially allowed interested parties until December
7, 1999 to file comments to its second proposal, but extended that
period until January 6, 2000. The Department received 37 written
submissions before the close of the comment period, from groups
representing both coal miners and coal mine operators. The Department
also received comments from individual miners, various coal mining and
insurance companies, as well as from claims processing organizations,
attorneys, and various professional organizations. The Department has
carefully reviewed all of the comments, and is issuing its final rule.
The rule contains a final regulatory flexibility analysis as required
by the Regulatory Flexibility Act.
EFFECTIVE DATE: January 19, 2001.
FOR FURTHER INFORMATION CONTACT: James L. DeMarce, (202) 693-0046.
SUPPLEMENTARY INFORMATION: The Department's final rule reprints 20 CFR
Parts 718 (except Tables B1 through B6 in Appendix B), 722, 725, and
726 in their entirety. The Department has not revised all of the
regulations in these parts. A detailed list of the regulations to which
the Department has made substantive revisions follows the Summary of
Noteworthy Regulations below, accompanied by a list of regulations to
which the Department has made technical revisions, a list of
regulations that the Department has deleted, and a list of regulations
that the Department has not changed in any manner.
Summary of Noteworthy Provisions
District Director Claims Processing
These final regulations implementing the Black Lung Benefits Act
provide simplified administrative procedures for the adjudication of
claims pending before the Office of Workers' Compensation Programs
(OWCP). The new streamlined procedures are less formal and should be
easier for claims participants to understand. They require the district
director to issue fewer documents and therefore involve fewer
procedural steps and deadlines. They also require fewer responses from
the parties. These changes are in response to the many comments the
Department has received asking that OWCP's procedures be simplified and
made less formal and adversarial.
In its initial notice of proposed rulemaking, the Department
announced its intent to amend these regulations with the goal of
helping to improve services, streamline the adjudication process and
simplify the regulations' language. The Department noted OWCP's many
years of experience administering the program and the variety of ideas
for change which had resulted from it. 62 FR 3338 (Jan. 22, 1997). In
the second notice of proposed rulemaking, the Department emphasized its
commitment to improve the quality of the information it provides the
parties to a black lung claim. As part of this commitment, the
Department noted its intent to substantially rewrite the documents used
by district directors to notify parties of the ``initial findings'' on
their claims. The Department stated its goal was to help make claim
processing by district offices easier to understand and to give
claimants a clear picture of the medical evidence developed in
connection with their claims so that they were able to make more
informed decisions as to how to proceed. The Department also noted that
it had attempted to ``eliminat[e] the hierarchy of response times'' at
the district director level. 64 FR 54992 (Oct. 8, 1999). After the
receipt of many comments addressing its proposals, the Department has
determined that a more comprehensive streamlining of district director
procedures is warranted.
The Department has therefore eliminated the use of initial findings
and the required responses to them, as well as the district director's
initial adjudication as proposed in Secs. 725.410-725.413. Similarly,
the Department has altered the rules governing informal conferences,
Sec. 725.416. If a conference is held, no memorandum of conference will
result, Sec. 725.417(c). Instead, OWCP will issue only one decisional
document at the conclusion of the district director's processing of a
claim: in most cases a proposed decision and order, Sec. 725.418. The
proposed decision and order will give rise to the thirty-day period for
requesting a hearing before the Office of Administrative Law Judges
and, if no such hearing is requested, to the one-year period for filing
a request for modification, Sec. 725.419. The proposed decision and
order will also contain the district director's final designation of
the responsible operator liable for the payment of benefits, and the
dismissal of all other potentially liable operators that had previously
received notice of the claim.
The Department hopes that the absence of documents with titles such
as ``initial findings'' and ``memorandum of conference'' will encourage
a less adversarial and less formal development of the necessary
evidence and will promote more timely evidentiary development. As
previously proposed, the district director will engage in a preliminary
gathering of the relevant evidence. He will develop medical evidence,
including the complete pulmonary evaluation, Secs. 725.405-725.406. He
will identify and notify those coal mine operators among the claimant's
former employers which he deems to be potentially liable operators,
Sec. 725.407, and gather evidence from them regarding their employment
of the miner and their status as operators, Sec. 725.408. At the
conclusion of this evidence-gathering, however, rather than issue an
initial finding (a document with the appearance of a preliminary
adjudication of the claim), the district director will issue a schedule
for the submission of additional evidence, Sec. 725.410. This
[[Page 79921]]
document will contain a summary of the results of the complete
pulmonary evaluation and the district director's preliminary analysis
of that evidence. The analysis will include a discussion of any of the
elements of entitlement that appear not to have been established and
why. The schedule will also contain the district director's designation
of a responsible operator liable for the payment of claimant's
benefits. If the designated responsible operator is not the miner's
last employer, the district director will include with the schedule the
statements necessary to comply with Sec. 725.495(d).
The schedule will allow the claimant and the designated responsible
operator not less than 60 days to submit additional evidence, including
evidence relevant to the claimant's entitlement to benefits and the
employer's liability for them. The schedule will also allow at least an
additional 30 days within which to respond to evidence the other party
submits, Sec. 725.410(b). These time periods may be extended for good
cause shown, Sec. 725.423. The district director will serve the
schedule by certified mail on all parties and will include with it
copies of all relevant evidence, Sec. 725.410(c). The schedule will
also inform the claimant and the designated responsible operator of
their rights, including the right to submit additional evidence and the
right to further adjudication of the claim, Sec. 725.410(a)(4).
Finally, the schedule will notify the claimant that he has the right to
obtain representation and that, if the designated responsible operator
fails to accept the claimant's entitlement within the specified time
and the claimant establishes his entitlement to benefits payable by
that operator, the responsible operator will be liable for a reasonable
attorney's fee.
The new procedure requires a responsible operator to respond within
30 days as to the liability designation in the schedule,
Sec. 725.412(a)(1). Silence on the responsible operator's part will be
deemed an acceptance of the district director's designation as to its
liability. Silence on the operator's part with respect to claimant's
entitlement, however, will be deemed a controversion. If the operator
wishes to accept a claimant's entitlement to benefits, it must file a
statement indicating this intent within 30 days of issuance of the
district director's schedule, Sec. 725.412(b). Thus, this schedule
requires a less comprehensive operator response than the initial
findings would have. The responsible operator must file a response only
to contest its liability and/or to accept a claimant's entitlement to
benefits. In addition, fewer parties are required to respond to the
schedule since the claimant need not respond at all.
By contrast, if the district director concludes that there is no
operator responsible for the payment of benefits and that the results
of the complete pulmonary evaluation support a finding of eligibility,
the district director shall issue a proposed decision and order
awarding the claimant benefits, Sec. 725.411. In such a case, no
schedule for the submission of additional evidence is necessary, and no
claimant response to the proposed decision and order is required.
At the conclusion of the time scheduled for the submission of
additional evidence, Sec. 725.415(b), the district director may either
notify additional operators of their potential liability for benefits
under Sec. 725.407, issue another schedule for the submission of
additional evidence identifying another potentially liable operator as
the responsible operator liable for the payment of benefits,
Sec. 725.410, schedule a case for an informal conference, Sec. 725.416,
or issue a proposed decision and order, Sec. 725.418. In the event the
district director issues another schedule for the submission of
additional evidence pursuant to Sec. 725.410, the district director
shall not permit the development or submission of any additional
medical evidence until after he has determined the responsible operator
liable for the payment of benefits. If the operator determined to be
the responsible operator has not had the opportunity to submit medical
evidence, the district director shall afford that operator the
opportunity outlined in Sec. 725.410. The designated responsible
operator may elect to adopt any medical evidence previously submitted
by another operator as its own, subject to the Sec. 725.414
limitations.
The regulations also contain significant modifications to the
informal conference procedure in order to reduce delay and to ensure
that conferences are held only in appropriate cases. Thus, if an
informal conference is scheduled, it must be held within 90 days of the
conclusion of the evidentiary development period unless a party
requests that it be postponed for good cause, Sec. 725.416(a). A
district director may schedule a conference only if all the parties to
a claim are represented or deemed represented, although lay
representation is sufficient, Sec. 725.416(b). If all the pertinent
requirements are met, however, and an informal conference is scheduled,
the unexcused failure of a party to appear constitutes grounds for the
imposition of sanctions, Sec. 725.416(c). These sanctions may include
denial of the claim by reason of abandonment, Sec. 725.409(a)(4). In
the event an ALJ ultimately reviews the denial by reason of abandonment
and concludes that it was improper, he may proceed to address the
merits of the claim, but only with the written agreement of the
Director, Sec. 725.409(c).
In most cases, however, at the conclusion of either the evidentiary
development period or informal conference proceedings, the district
director will issue a proposed decision and order setting forth his
findings and conclusions with respect to the claim. In order to reduce
the delay caused by informal conferences, the regulations require
issuance of a proposed decision and order within 20 days after the
conclusion of all informal conference proceedings, Sec. 725.418(a). The
proposed decision and order will contain the district director's final
designation of the responsible operator liable for the payment of
benefits, and will dismiss, as parties to the claim, all other
potentially liable operators that received notification pursuant to
Sec. 725.407. Any party may request a hearing within 30 days of
issuance of the decision and order, Sec. 725.419(a). If no party
responds to the proposed decision, it shall become final and effective
upon the expiration of the 30-day period and no further proceedings
with respect to the claim shall be possible, except for the filing of a
request for modification, Sec. 725.419(d).
The Department hopes that this simplified procedure will reduce, if
not eliminate, hearing requests filed before the conclusion of a
district director's claims processing. In the event a hearing request
is filed before a district director has concluded his adjudication of
the claim, however, OWCP will honor the request at the conclusion of
processing in the absence of a party's affirmative statement that it no
longer desires a hearing. Thus, if a claimant has previously requested
a hearing and has been denied benefits in a proposed decision and
order, the case will be forwarded to the Office of Administrative Law
Judges for hearing in the absence of a statement that a hearing is no
longer desired. Similarly, if an operator has previously requested a
hearing, and the proposed decision and order awards the claimant
benefits, OWCP will forward the claim for hearing absent a statement
from the operator that it no longer desires a hearing, Sec. 725.418(c).
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Evidentiary Development
Documentary Evidence
With one substantive addition and several deletions, these final
rules implement the Department's second proposal with respect to the
development of both documentary medical evidence and evidence
pertaining to operator liability. The designated responsible operator
may submit documentary medical evidence either to the district director
or to the administrative law judge (ALJ) up to 20 days before an ALJ
hearing, or even thereafter, if good cause is shown. Documentary
medical evidence may only be submitted up to the numerical limitations
outlined in Secs. 725.414(a), however, absent a showing of good cause,
Sec. 725.456(b). Thus, each side in a claim may submit two chest x-ray
interpretations, the results of two pulmonary function tests, two
arterial blood gas studies and two medical reports as its affirmative
case. In addition, each party may submit one piece of evidence in
rebuttal of each piece of evidence submitted by the opposing party.
Finally, in a case in which rebuttal evidence has been submitted, the
party that originally proferred the evidence which has been the subject
of rebuttal may submit one additional statement to rehabilitate its
evidence.
By contrast, documentary evidence as to operator liability must be
submitted to the district director, absent a showing of exceptional
circumstances, Secs. 725.408(b)(2), 725.414(d), 725.456(b). There is no
limit on the amount of such evidence that may be submitted, however.
At the urging of commenters representing both industry and
claimants, the Department has made one addition to Sec. 725.414(a). The
Department has added a specific limitation on the amount of autopsy and
biopsy evidence which may be submitted in a claim. Each side may submit
one autopsy report and one report of each biopsy as part of an
affirmative case. Each side may submit one autopsy report and one
report of each biopsy in rebuttal of the opponent's case. Finally,
where the original autopsy or biopsy evidence has been the subject of
rebuttal, the party that submitted the original report may submit an
additional statement from the physician who authored that report.
The Department has deleted language throughout Sec. 725.414
referring to potentially liable operators since only the designated
responsible operator and/or the Trust Fund will have the authority to
develop documentary medical evidence in a claim. The Department has
also deleted one provision of proposed Sec. 725.414, Sec. 725.414(e),
as well as the comparable provision proposed as Sec. 725.456(c). These
subsections would have provided that any evidence obtained by a party
while a claim was pending before a district director but withheld from
the district director or any other party shall not be admitted into the
record in any later proceedings in the absence of extraordinary
circumstances unless its admission is requested by another party.
Commenters opposed these provisions, and the Department has agreed to
delete them. The Department believes they are no longer necessary,
given the significant alteration in the district director's methods for
gathering evidence under the new regulations, see preamble to
Sec. 725.456. In addition, these rules would have posed a danger to
parties who are unrepresented before the district director and might
have run afoul of the rules unintentionally.
Complete Pulmonary Evaluation
With one exception, these final rules implement the Department's
second proposal with respect to the administration of the complete
pulmonary evaluation required by 30 U.S.C. 923(b). The Department will
allow each claimant to select the physician or facility to perform his
evaluation from a list of authorized providers maintained by the
Department. The list in each case will include all authorized
physicians and facilities in the state of the miner's residence and
contiguous states, Sec. 725.406(b). The Department will also make
available to the claimant's treating physician, at the claimant's
request, the results of the objective testing administered as part of
the complete pulmonary evaluation and will inform the claimant that any
opinion submitted by his treating physician will count as one of the
two medical reports that the miner may submit, Sec. 725.406(d).
The Department has not included in the final regulation at
Sec. 725.406, however, the provision proposed as subsection (e) which
would have allowed the district director to require the claimant to be
reexamined after the completion of the complete pulmonary evaluation if
the district director believed that unresolved medical questions
remained. Commenters from both industry and claimants' groups opposed
this provision, and the Department has concluded it is no longer
necessary. The complete pulmonary evaluation will now be performed by a
highly qualified physician who may be asked by the district director to
clarify and/or supplement an initial report if unresolved medical
questions remain. In addition, the components of the complete pulmonary
evaluation are to be in substantial compliance with the applicable
quality standards and the district director retains authority elsewhere
in Sec. 725.406 to schedule the miner for further examination or
testing to ensure compliance with these standards.
In the second notice of proposed rulemaking, the Department also
announced its intent to perform the best possible respiratory and
pulmonary evaluation of miners applying for benefits. The Department
promised a thorough examination, performed in compliance with the
quality standards, in order to provide each claimant with a realistic
appraisal of his condition and the district director with a sound
evidentiary basis for a preliminary evaluation of the claim. The
Department also announced its intent to develop more rigorous standards
for physicians who perform complete pulmonary evaluations. The
Department invited the interested public to comment on the possible
standards that might be used to select physicians and facilities, 64 FR
54988-54989 (Oct. 8, 1999).
The comments the Department received are discussed in detail in the
preamble to Sec. 725.406. It is the Department's intent, however, to
include in its Black Lung Program Manual the requirements for a
physician's or medical facility's inclusion on the list. The Manual is
available to the public in every district office of OWCP. Thus, the
requirements for participation in OWCP's program and the manner in
which the Department has used those requirements to select physicians
for inclusion on the approved list will be public information. The
Department does not intend to screen the contents of physicians' prior
reports and testimony before including them on the list. The Department
intends only to ascertain that the required professional credentials
are present.
Witnesses
These final rules adopt the provisions governing witness testimony
proposed in the Department's second notice of proposed rulemaking. No
person shall be permitted to testify as a witness at a hearing,
pursuant to deposition or by interrogatory unless that person meets the
requirements of Sec. 725.414(c). Thus, in the case of a witness
offering testimony relevant to the liability of a potentially liable
operator or the identification of a responsible operator,
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the witness must have been identified while the claim was pending
before the district director in the absence of extraordinary
circumstances, Sec. 725.457(c)(1). In the case of a physician offering
testimony relevant to the physical condition of the miner, the
physician must have prepared a medical report submitted into evidence.
Alternatively, the party offering the physician's testimony must have
submitted fewer than two medical reports into evidence in which case
the physician's testimony shall be considered a medical report for the
purpose of the evidentiary limitations in Sec. 725.414(c). A party may
offer the testimony of more than two physicians only upon a finding of
good cause, Sec. 725.457(c)(2).
Treating Physicians' Opinions
The Department has adopted a rule governing the weighing of
treating physicians' opinions similar to the one proposed in its second
notice of proposed rulemaking, Sec. 718.104(d). The rule is discussed
in detail in the preamble to Sec. 718.104. The language of
Sec. 718.104(d) has been altered to provide that, in appropriate cases,
the relationship between the miner and his treating physician may
constitute substantial evidence in support of the adjudication
officer's decision to give that physician's opinion controlling weight.
See Sec. 718.104(d)(5). The rule's purpose is to recognize that a
physician's professional relationship with the miner may enhance his
insight into the miner's pulmonary condition. A treating physician may
develop a more in-depth knowledge and understanding of the miner's
respiratory and pulmonary condition than a physician who examines the
miner only once or who reviews others' examination reports. Section
718.104(d) is not an outcome-determinative evidentiary rule, however.
It does not preclude consideration of other relevant evidence of
record. Rather, it provides criteria for evaluating the quality of the
doctor-patient relationship. The criteria at Sec. 718.104(d)(1)-(4) are
indicia of the potential insight the physician may have gained from on-
going treatment of the miner. The rule is designed to force a careful
and thorough assessment of the treatment relationship. If the
adjudicator concludes the treating physician has a special
understanding of the miner's pulmonary health, that opinion may receive
``controlling weight'' over contrary opinions. That determination may
be made, however, only after the adjudicator considers the credibility
of the physician's opinion in light of its documentation and reasoning
and the relative merits of the other relevant medical evidence of
record.
Definition of Pneumoconiosis and Establishing Total Disability Due to
Pneumoconiosis
The Department has adopted the proposed definition of
pneumoconiosis without alteration. In the preamble to Sec. 718.201, the
Department explains that the term ``legal pneumoconiosis'' does not
create a new medical diagnosis, but rather reflects the statute's
definition of the disease as ``a chronic dust disease of the lung and
its sequelae, including respiratory and pulmonary impairments, arising
out of coal mine employment.'' 30 U.S.C. 902(b). The preamble also
explains in detail the Department's decision to include chronic
obstructive pulmonary disease in the definition of pneumoconiosis to
the extent it is shown to have arisen from coal mine employment. The
Department attempts to clarify that not all obstructive lung disease is
pneumoconiosis. It remains the claimant's burden of persuasion to
demonstrate that his obstructive lung disease arose out of his coal
mine employment and therefore falls within the statutory definition of
pneumoconiosis. The Department has concluded, however, that the
prevailing view of the medical community and the substantial weight of
the medical and scientific literature supports the conclusion that
exposure to coal mine dust may cause chronic obstructive pulmonary
disease. Each miner must therefore be given the opportunity to prove
that his obstructive lung disease arose out of his coal mine employment
and constitutes ``legal'' pneumoconiosis.
The Department has also adopted the proposed regulation defining
total disability and disability due to pneumoconiosis with one
alteration, Sec. 718.204. To clarify its original intent concerning the
extent to which pneumoconiosis must contribute to a miner's total
disability, the Department has amended the language of
Secs. 718.204(c)(1)(i) and 718.204(c)(1)(ii) by adding the words
``material'' and ``materially.'' Thus, a miner has established that his
pneumoconiosis is a substantially contributing cause of his disability
if it either has a material adverse effect on his respiratory or
pulmonary condition or materially worsens a totally disabling
respiratory or pulmonary impairment caused by a disease or exposure
unrelated to coal mine dust. Evidence that pneumoconiosis made only a
negligible, inconsequential or insignificant contribution to the
miner's disability is insufficient to establish total disability due to
pneumoconiosis. This change is discussed in detail in the preamble at
Sec. 718.204. The Department has also adopted one important proposed
change with respect to the clinical evidence which may be used to
establish total disability, see preamble to Sec. 718.103. The
Department has concluded that the claims adjudication process would
benefit by making mandatory the use of the flow-volume loop in
pulmonary function testing (spirometry testing). The Department has
previously noted that the test, conducted in this manner, provides a
``more reliable method of ensuring valid, verifiable results * * *.''
64 FR 54975 (Oct. 8, 1999). In the second notice of proposed
rulemaking, the Department announced its intent to conduct a survey of
physicians, clinics and facilities which perform pulmonary function
testing to evaluate the prevalence of spirometers capable of producing
a flow-volume loop. The Department has now evaluated the results of its
survey and has concluded that the prevalence of the necessary equipment
and the willingness of those physicians who do not currently have it to
buy it, warrant the mandatory usage of such equipment.
Subsequent Claims
These final rules adopt the regulation governing subsequent claims
that was proposed in the Department's second notice of proposed
rulemaking. A subsequent claim is an application for benefits filed
more than one year after the denial of a previous claim. It may be
adjudicated on its merits only if the claimant demonstrates that an
applicable condition of entitlement has changed in the interim. In the
second proposal, the Department justified the rule by noting that
``allowing the filing of a subsequent claim for benefits which alleges
a worsening of the miner's condition, * * * merely recognizes the
progressive nature of pneumoconiosis.'' 64 FR 54968 (Oct. 8, 1999). In
the preamble to Sec. 725.309, the Department responds in detail to
those commenters who oppose the regulation. They argue, in part, that
the Department's recognition of pneumoconiosis as a latent and
progressive disease is scientifically unsound. The Department has
summarized the scientific and medical evidence supporting its view that
pneumoconiosis is both latent and progressive and has responded to the
criticism leveled at that evidence. It is the Department's conclusion
that the record contains abundant evidence to justify the regulation
governing subsequent claims.
[[Page 79924]]
Attorneys' Fees
With minor changes, these final rules promulgate the regulation
governing the payment of a claimant's attorney's fee as it was proposed
in the Department's second notice of proposed rulemaking, Sec. 725.367.
The Department wishes to encourage attorneys to represent claimants
early in the administrative process, given the important decisions
which may be made by a claimant while a claim is pending before the
district director. For example, the rules now limit the quantity of
medical evidence that a claimant may submit in support of his
entitlement. A claimant may request that the Department send the
objective test results from his complete pulmonary evaluation to his
treating physician. Any treating physician's opinion which is submitted
to the district director, however, may become one of the claimant's two
medical reports. The Department's rule governing attorney's fees,
therefore, seeks to encourage early attorney involvement by providing a
different starting point for employer and Fund attorney fee liability.
Although the creation of an adversarial relationship and the ultimately
successful prosecution of a claim are still necessary to trigger
employer or Fund liability, once that liability is triggered, a
reasonable fee will be awarded for all necessary work performed, even
if it was performed before the creation of the adversarial
relationship.
The text of the regulation has been altered in minor ways. The
language describing the fee to which an attorney is entitled has been
amended to conform with Sec. 725.366. Section 725.367 therefore
provides for the payment of a ``reasonable fee[] for necessary services
performed. * * *'' In addition, the regulation has been amended to
conform with the revised district director claims procedure. Thus,
Sec. 725.367(a)(1) now provides that if the responsible operator
designated by the district director pursuant to Sec. 725.410(a)(3)
fails to accept the claimant's entitlement to benefits within the 30
day period provided by Sec. 725.412(b) and is ultimately determined to
be liable for benefits, the operator shall also be liable for a
reasonable attorney's fee. Similarly, if there is no operator that may
be held liable for the payment of benefits, the district director
issues a schedule for the submission of additional evidence under
Sec. 725.410, and the claimant successfully prosecutes his application
for benefits, the Fund will be liable for a reasonable attorney's fee,
Sec. 725.367(a)(2). Finally, if the district director issues more than
one schedule for the submission of additional evidence in order to
designate a different operator as the responsible operator, and that
operator is ultimately determined to be liable for the payment of
benefits, that operator will be liable for the payment of claimant's
attorney's fee if it fails to accept the claimant's entitlement within
30 days of the date upon which it is notified of its designation as
responsible operator.
True Doubt
The Department has not adopted a ``true doubt'' rule in these
regulations. The ``true doubt'' rule was an evidentiary weighing
principle under which an issue was resolved in favor of the claimant if
the probative evidence for and against the claimant was in equipoise.
The Department believes that evaluation of conflicting medical evidence
requires careful consideration of a wide variety of disparate factors
affecting the credibility of that evidence. The presence of these
factors makes it unlikely that a factfinder will be able to conclude
that conflicting evidence is truly in equipoise. See preamble to
Sec. 718.3.
Criteria for Determining a Responsible Operator
The Department has made two changes to the regulation governing the
identification of a responsible operator, Sec. 725.495. That regulation
now provides that if the miner's most recent employer was a self-
insured operator which no longer possesses sufficient assets to secure
the payment of benefits when the miner files his claim, the Department
will not name a previous employer as responsible operator. Rather, the
claim will be the responsibility of the Black Lung Disability Trust
Fund. The Department has made this change in response to a comment that
stated that it is unfair to name a prior employer as liable for a claim
when the financial inability of the later employer to pay the claim is
the fault of the Department. Because the Department has the authority
to accept or reject applications for self-insurance and to set minimum
standards for qualifying as a self-insurer, the Department agrees with
the commenter. Thus, to the extent the security deposited by a self-
insured coal mine operator pursuant to Sec. 726.104 proves insufficient
to pay individual claims, liability will not be placed on previous
employers, but rather on the Trust Fund. The Department has also
altered the language of Sec. 725.495(d) to reflect the changes made in
the regulations governing district director claims processing,
Secs. 725.410-725.413. The district director will no longer issue an
initial finding naming a responsible operator but rather will finally
designate in a proposed decision and order one operator as the
responsible operator liable for a claim, Sec. 725.418(d).
Insurance Endorsement
In the second notice of proposed rulemaking, the Department opened
Sec. 726.203 for comment, noting that representatives of the insurance
industry had told the Department that a different version of the
insurance endorsement than the one contained in Sec. 726.203(a) had
been in use since 1984 with the Department's consent. The Department
invited the submission of any document the insurance industry might
possess from the Department authorizing use of the different
endorsement. 64 FR 54969-70, 55005-06 (Oct. 8, 1999). The Department
has carefully considered the comments submitted in response to the
second notice of proposed rulemaking and declines to amend
Sec. 726.203. The revised black lung endorsement offered by the
commenters would materially alter the obligations and coverage provided
by the insurance industry, thereby increasing the potential exposure of
coal mine operators and the Black Lung Disability Trust Fund, see
preamble to Sec. 726.203.
Explanation of Changes
Complete List of Substantive Revisions
The Department has made substantive revisions to the following
regulations: Sec. 718.3, Sec. 718.101, Sec. 718.102, Sec. 718.103,
Sec. 718.104, Sec. 718.105, Sec. 718.106, Sec. 718.107, Sec. 718.201,
Sec. 718.202, Sec. 718.204, Sec. 718.205, Sec. 718.301, Appendix B to
part 718, Appendix C to Part 718, part 722 (entire), Sec. 725.1,
Sec. 725.2, Sec. 725.4, Sec. 725.101, Sec. 725.103, Sec. 725.202,
Sec. 725.203, Sec. 725.204, Sec. 725.209, Sec. 725.212, Sec. 725.213,
Sec. 725.214, Sec. 725.215, Sec. 725.219, Sec. 725.221, Sec. 725.222,
Sec. 725.223, Sec. 725.306, Sec. 725.309, Sec. 725.310, Sec. 725.311,
Sec. 725.351, Sec. 725.362, Sec. 725.367, Sec. 725.403, Sec. 725.405,
Sec. 725.406, Sec. 725.407, Sec. 725.408, Sec. 725.409, Sec. 725.410,
Sec. 725.411, Sec. 725.412, Sec. 725.413, Sec. 725.414, Sec. 725.415,
Sec. 725.416, Sec. 725.417, Sec. 725.418, Sec. 725.421, Sec. 725.423,
Sec. 725.452, Sec. 725.454, Sec. 725.456, Sec. 725.457, Sec. 725.458,
Sec. 725.459, Sec. 725.465, Sec. 725.478, Sec. 725.479, Sec. 725.490,
Sec. 725.491, Sec. 725.492, Sec. 725.493, Sec. 725.494, Sec. 725.495,
Sec. 725.502, Sec. 725.503, Sec. 725.515, Sec. 725.522, Sec. 725.530,
Sec. 725.533, Sec. 725.537, Sec. 725.543, Sec. 725.544, Sec. 725.547,
Sec. 725.548, Sec. 725.606,
[[Page 79925]]
Sec. 725.608, Sec. 725.609, Sec. 725.620, Sec. 725.621, Sec. 725.701,
Sec. 725.706, Sec. 726.2, Sec. 726.3, Sec. 726.8, Sec. 726.101,
Sec. 726.104, Sec. 726.105, Sec. 726.106, Sec. 726.109, Sec. 726.110,
Sec. 726.111, Sec. 726.114, Sec. 726.300, Sec. 726.301, Sec. 726.302,
Sec. 726.303, Sec. 726.304, Sec. 726.305, Sec. 726.306, Sec. 726.307,
Sec. 726.308, Sec. 726.309, Sec. 726.310, Sec. 726.311, Sec. 726.312,
Sec. 726.313, Sec. 726.314, Sec. 726.315, Sec. 726.316, Sec. 726.317,
Sec. 726.318, Sec. 726.319, and Sec. 726.320. Detailed explanations of
the reasons for the Department's revisions may be found in the
discussion of individual regulations below.
Complete List of Technical Revisions
The Department has made only technical changes to the following
regulations: Sec. 718.1, Sec. 718.2, Sec. 718.4, 718.303, Appendix A to
Part 718, Sec. 725.3, Sec. 725.102, Sec. 725.201, Sec. 725.206,
Sec. 725.207, Sec. 725.216, Sec. 725.217, Sec. 725.218, Sec. 725.220,
Sec. 725.301, Sec. 725.302, Sec. 725.350, Sec. 725.360, Sec. 725.366,
Sec. 725.401, Sec. 725.402, Sec. 725.404, Sec. 725.419, Sec. 725.420,
Sec. 725.450, Sec. 725.451, Sec. 725.455, Sec. 725.462, Sec. 725.463,
Sec. 725.466, Sec. 725.480, Sec. 725.496, Sec. 725.497, Sec. 725.501,
Sec. 725.504, Sec. 725.505, Sec. 725.506, Sec. 725.507, Sec. 725.510,
Sec. 725.513, Sec. 725.514, Sec. 725.521, Sec. 725.531, Sec. 725.532,
Sec. 725.536, Sec. 725.540, Sec. 725.601, Sec. 725.603, Sec. 725.604,
Sec. 725.605, Sec. 725.607, Sec. 725.702, Sec. 725.703, Sec. 725.704,
Sec. 725.705, Sec. 725.707, Sec. 725.708, Sec. 725.711, Sec. 726.1,
Sec. 726.4, Sec. 726.103, Sec. 726.203, Sec. 726.207, Sec. 726.208,
Sec. 726.209, Sec. 726.210, Sec. 726.211, Sec. 726.212, and
Sec. 726.213. In its first notice of proposed rulemaking, the
Department revised Sec. 725.3 to create a new subpart E in part 725,
and to recognize the relabeling of the remaining subparts. The
Department inadvertently omitted the regulation from the list of
technical revisions, however. Accordingly, Sec. 725.3 now appears in
the complete list of technical revisions. The Department also
inadvertently omitted Secs. 725.206 and 725.540 from the list of
technical revisions. The Department added a reference to Sec. 725.4(d)
to each regulation, see 62 FR 3340-41 (Jan. 22, 1997). The Department
also inadvertently omitted Sec. 725.207 from the list of technical
revisions. The Department replaced commas in subsections (b) and (c)
with the word ``and.'' The Department also inadvertently omitted
Sec. 725.497 from the list of technical revisions. The Department
replaced references to the ``Trust Fund'' with references to the
``fund,'' the term defined in Sec. 725.101(a)(8), and capitalized the
word ``section'' in subsections (a) and (b). Finally, the Department
inadvertently omitted Sec. 725.601 from the list of technical
revisions. The Department replaced references to ``deputy
commissioner'' with references to ``district director,'' see 62 FR 3340
(Jan. 22, 1997), and replaced a reference to the ``Trust Fund'' with a
reference to the ``fund.'' The Department explained the other technical
changes that it was making to the regulations in its first and second
notices of proposed rulemaking. See 62 FR 3340-41 (Jan. 22, 1997); 64
FR 54970 (Oct. 8, 1999). With the exception of Sec. 726.203, none of
the regulations listed above were open for comment. The Department's
decision not to revise Sec. 726.203, other than the technical revisions
discussed in the Department's first notice of proposed rulemaking, is
explained in the preamble to Sec. 726.203.
Complete List of Deleted Regulations
The following regulations have been deleted: Sec. 718.307,
Sec. 718.401, Sec. 718.402, Sec. 718.403, Sec. 718.404, Sec. 725.453A,
Sec. 725.459A, Sec. 725.503A, Sec. 725.701A, and part 727 (entire). The
Department explained its decision to incorporate the text of sections
725.453A, 725.459A, 725.503A, and 725.701A into other regulations in
its first notice of proposed rulemaking. See list of Technical
revisions, 62 FR 3341 (Jan. 22, 1997). Detailed explanations of the
Department's decision to delete the remaining regulations in this list
may be found in the discussion of individual regulations below.
Complete List of Unchanged Regulations
The following regulations have not been revised: Sec. 718.203,
Sec. 718.206, Sec. 718.302, Sec. 718.304, Sec. 718.305, Sec. 718.306,
Sec. 725.205, Sec. 725.208, Sec. 725.210, Sec. 725.211, Sec. 725.224,
Sec. 725.225, Sec. 725.226, Sec. 725.227, Sec. 725.228, Sec. 725.229,
Sec. 725.230, Sec. 725.231, Sec. 725.232, Sec. 725.233, Sec. 725.303,
Sec. 725.304, Sec. 725.305, Sec. 725.307, Sec. 725.308, Sec. 725.352,
Sec. 725.361, Sec. 725.363, Sec. 725.364, Sec. 725.365, Sec. 725.422,
Sec. 725.453, Sec. 725.460, Sec. 725.461, Sec. 725.464, Sec. 725.475,
Sec. 725.476, Sec. 725.477, Sec. 725.481, Sec. 725.482, Sec. 725.483,
Sec. 725.511, Sec. 725.512, Sec. 725.520, Sec. 725.534, Sec. 725.535,
Sec. 725.538, Sec. 725.539, Sec. 725.541, Sec. 725.542, Sec. 725.545,
Sec. 725.546, Sec. 725.602, Sec. 725.710, Sec. 726.5, Sec. 726.6,
Sec. 726.7, Sec. 726.102, Sec. 726.107, Sec. 726.108, Sec. 726.112,
Sec. 726.113, Sec. 726.115, Sec. 726.201, Sec. 726.202, Sec. 726.204,
Sec. 726.205, and Sec. 726.206. The Department did not accept comments
on these regulations, and is re-promulgating the regulations for the
convenience of readers.
For purposes of this preamble, ``he'', ``his'', and ``him'' shall
include ``she'', ``hers'', and ``her''.
20 CFR Part 718--Standards for Determining Coal Miners' Total
Disability or Death Due to Pneumoconiosis
Subpart A--General
20 CFR 718.3
(a)(i) In the initial notice of proposed rulemaking, the Department
invited public comment on the continued use of the ``true doubt'' rule,
and specifically on the language contained in Sec. 718.3(c), which had
been cited to the Supreme Court in support of the rule. 62 FR 3341
(Jan. 22, 1997). The ``true doubt'' rule is an evidentiary principle
which requires the adjudicator to find in favor of the claimant on a
factual issue if the evidence for and against the claimant is evenly
balanced. The Supreme Court invalidated the ``true doubt'' rule in
Director, OWCP v. Greenwich Collieries, 512 U.S. 267 (1994). The Court
held Sec. 718.3(c) failed to define the rule effectively, and that the
rule, as applied by the Benefits Review Board, violated the
Administrative Procedure Act (APA), 5 U.S.C. 551 et seq., by relieving
the claimant of the burden of proving his or her claim by a
preponderance of the evidence (the ``burden of persuasion''). The
Department therefore proposed deleting Sec. 718.3(c) and moving the
existing 20 CFR 718.403 (1999) (``Burden of proof'') to proposed
Sec. 725.103. (ii) In the second notice of proposed rulemaking, the
Department addressed the comments responding to the proposed deletion
of paragraph (c). 64 FR 54974 (Oct. 8, 1999). Some comments urged the
Department to promulgate a version of the ``true doubt'' rule which
would comply with Greenwich Collieries. Other comments suggested
retaining paragraph (c) as a statement of general principle and a
reminder to adjudicators of the purpose of the Black Lung Benefits Act
(BLBA). The Department rejected both suggestions. The Department
concluded a ``true doubt'' evidentiary rule would not improve claims
adjudication. Rather, the factfinder must conduct an in-depth analysis
of the medical evidence in each case, and resolve credibility issues.
The Department also noted that evidence is rarely in equipoise because
a factfinder must consider such a wide variety of factors in weighing
it: Physicians' qualifications, clinical documentation,
[[Page 79926]]
reasoning, relationship to other medical evidence, etc. With respect to
paragraph (c) as a statement of principle, the Department considered
the provision unnecessary because it would be unenforceable, and
because the principles appear in the legislative history of the BLBA
which may be cited by a party in litigation. Moreover, the Department
noted it had addressed the difficulties confronted by claimants in
proving their claims in other regulations, e.g., by requiring
substantial compliance rather than strict compliance with the quality
standards for medical evidence. (iii) The Department has received four
additional comments concerning the ``true doubt'' rule.
(b) Two comments observe that the Department has the regulatory
authority to promulgate a ``true doubt'' rule which will comply with
Greenwich Collieries, and three comments urge the need for such a rule
to implement Congressional intent that all reasonable doubt be resolved
in the claimant's favor. The Department recognizes that it has the
statutory authority to depart from the requirements of the APA and
allocate burdens of production and persuasion among the parties. The
Department, however, does not believe codification of the ``true
doubt'' rule is necessary to afford claimants the protections Congress
intended in directing resolution of reasonable doubts in their favor.
Rather than a statement of general principle, the Department has
provided assistance to claimants in other ways. As noted in the second
notice of proposed rulemaking, the Department eased the level of
compliance with the quality standards for clinical tests and medical
reports from strict adherence to ``substantial compliance.'' 64 FR
54974 (Oct. 8, 1999). The reduced standard allows the adjudicator more
leeway to determine in each particular case whether any defects in
compliance undermine the credibility of the test or report. Another
example is the ``treating physician'' rule in Sec. 718.104(d). The
regulation enhances the weight an adjudicator may give to a miner's
treating physician's opinion provided the opinion meets certain
standards. In addition, Sec. 725.406(d) provides each claimant with the
opportunity to have his or her treating physician receive objective
test results (such as a chest x-ray reading and pulmonary function
study results), in substantial compliance with the regulations' quality
standards. This provision ensures that the claimant's treating
physician's opinion may be based on complying evidence. Finally, the
Department has adopted burden-shifting presumptions such as the default
onset date for the commencement of benefits, Sec. 725.503(b), (d), and
the presumption of coverage for pulmonary-related medical benefits,
Sec. 725.701(e), which assist claimants on medical treatment issues.
These provisions significantly reduce the need for a ``true doubt''
rule.
(c) Three comments contend a ``true doubt'' rule is necessary
because the limitations on the quantity of medical evidence imposed by
the regulations will result in increased instances in which the
evidence for and against entitlement is in equipoise despite scrupulous
consideration of all relevant factors affecting credibility. The
Department disagrees. The adjudicator must examine several variables in
weighing the credibility of each item of medical evidence, especially
physicians' opinions. Age of the opinion, reasoning, underlying
clinical data, the physician's level of expertise, reliability of
employment, social and medical histories, etc., are all factors to be
considered in each report. As for clinical studies, the quality
standards establish criteria to measure the reliability of the clinical
results, and physicians' reviews of the results provide additional
information on the studies' validity. When all available information is
assembled, the Department believes few medical records for and against
entitlement will be in equipoise. Furthermore, the limitations on
evidence should prompt each party to bolster the credibility of its
medical evidence and challenge the credibility of its opponent's case.
(d) One comment states the ``true doubt'' rule is especially needed
for weighing chest x-rays because that type of evidence involves very
few variables (film quality, readers' expertise) which can affect the
credibility of the evidence. The Department believes no need exists to
adopt a specialized ``true doubt'' rule for use in weighing only x-
rays. Such a rule would place undue importance on one type of evidence,
and would overemphasize the role of x-rays in determining whether the
miner has pneumoconiosis. Chest x-rays are used to determine whether
the miner has ``clinical'' pneumoconiosis, i.e., ``the lung disease
caused by fibrotic reaction of the lung tissue to inhaled dust, which
is generally visible on chest x-rays as opacities.'' Hobbs v.
Clinchfield Coal Co., 917 F.2d 790, 791 n. 1 (4th Cir. 1990) (citation
omitted). The BLBA explicitly prohibits the denial of a claim based
solely on negative x-rays. 30 U.S.C. 923(b). The reason for this
prohibition is Congress' reservations about the reliability of negative
x-rays as trustworthy evidence that the miner does not have
pneumoconiosis. Usery v. Turner Elkhorn Mining Co., 428 U.S. 1, 31-34
(1976). Consequently, Congress has limited the use of negative x-rays
in evaluating a miner's entitlement to benefits. Even if the x-ray
readings in a particular claim appear to be truly balanced and
therefore insufficient to meet the preponderance standard, however, the
claimant may nevertheless establish the existence of clinical
pneumoconiosis. For example, a factfinder might find one x-ray reading
more credible than another based on a radiologist's explanation,
contained in a supplemental report or deposition testimony, of the
reasons for his x-ray diagnosis. Such reasons may include consideration
of the miner's complete occupational history, including the length of
his or her coal mine employment, and the absence of other injurious
exposures, see 45 FR 13687, Discussion and changes, Sec. 718.202 (Feb.
29, 1980). In addition, a claimant may prove the existence of ``legal''
pneumoconiosis. This broader category of compensable disease comprises
``all lung diseases which * * * [are] significantly related to, or
substantially aggravated by, dust exposure in coal mine employment.''
Hobbs, 917 F.2d 4 791 n. 1; see also Barber v. Director, OWCP, 43 F.3d
899, 901 (4th Cir. 1995). In weighing medical evidence relevant to
``legal'' pneumoconiosis, the adjudicator may consider a variety of
factors which affect the weight of the medical evidence, e.g., the
physicians' expertise, the reasoning and documentation in the medical
reports, the comparative consistency or inconsistency of the opinions
with other medical evidence such as hospital reports, etc. A claimant
has ample opportunity to establish that (s)he has a lung disease caused
by coal mine employment in addition to the narrow type of disease
discoverable by x-rays. The Department therefore rejects the position
that a ``true doubt'' rule should be available for the purpose of
resolving conflicts in x-ray evidence.
(e) One comment suggests a ``true doubt'' rule would be useful in
resolving conflicts between qualifying and nonqualifying pulmonary
function and blood gas studies. The commenter acknowledges that more
factors exist to determine the credibility of these types of clinical
evidence than exist when chest x-ray evidence is in conflict, but
nevertheless recommends making the rule applicable in the event the
evidence is in equipoise. Both pulmonary function (Sec. 718.103) and
[[Page 79927]]
blood gas studies (Sec. 718.105) must comply with far more detailed
quality standards than x-rays. Although only ``substantial compliance''
is required under the regulations, the more detailed standards
necessarily provide more points of comparison between studies and more
bases for preferring one study to another. A party may challenge
another party's study by submitting expert opinion evidence
demonstrating the study is unreliable or invalid. Given the numerous
means of challenging or bolstering a study, the Department does not
believe a ``true doubt'' rule would play a significant role in weighing
pulmonary function studies and blood gas studies. No change in the
regulation is appropriate.
(f) No other comments have been received concerning this section,
and no changes have been made in it.
Subpart B
20 CFR 718.101
(a) In the initial notice of proposed rulemaking, the Department
added subsection (b) to emphasize that the part 718 quality standards
apply to all evidence developed by any party in connection with a claim
filed after March 31, 1980, and to claims governed by part 727 if the
evidence was developed after that date. 62 FR 3341 (Jan. 22, 1997).
Paragraph (b) also established a single standard of compliance for all
clinical tests and medical reports, in place of the varying standards
contained in the former individual regulations. The Department revised
paragraph (b) in the second notice of proposed rulemaking to clarify
that the quality standards will apply only prospectively to evidence
developed in connection with a claim, after promulgation of these
regulations. The Department noted it wished to avoid invalidating
evidence already submitted in pending claims based on the parties'
settled expectations. 64 FR 54974-75 (Oct. 8, 1999). The Department
also responded to numerous comments received after the initial notice
of proposed rulemaking. It rejected comments opposing the general
applicability of the quality standards to medical evidence and
advocating consideration of noncomplying evidence, citing the need for
technically accurate and reliable evidence for the adjudication of
entitlement issues. For the same reason, the Department rejected
comments disputing its authority to impose quality standards on medical
evidence as inconsistent with the Black Lung Benefits Act's (BLBA)
requirement that ``all relevant evidence'' be considered. See 30 U.S.C.
923(b). The Department concluded quality standards are consistent with
the mandated consideration of all relevant evidence because
noncomplying evidence is inherently unreliable, and therefore not
relevant to the adjudication of a claim. The Department rejected the
suggestion that the criteria enumerated in the quality standards should
provide the only grounds for invalidating medical evidence; rather,
parties may develop any evidence which addresses the validity of the
evidence. The Department explained there was no need to add an
exemption from the quality standards for hospitalization and treatment
records because Sec. 718.101 is clear that it applies quality standards
only to evidence developed ``in connection with a claim'' for black
lung benefits. Finally, the Department rejected as unnecessary a
requirement that the Department notify a party if its evidence is
noncomplying and allow it to rehabilitate the evidence because the
responsibility for submitting complying evidence rests with the party
submitting it. The district director is already responsible for
ensuring the complete pulmonary examination required by 30 U.S.C.
923(b) complies with all applicable quality standards. In addition, if
an opposing party challenges evidence as noncomplying, the party
originally submitting it may rehabilitate the evidence by submitting an
additional report from the author of the original report.
(b) Two comments reiterate the general argument that 30 U.S.C.
923(b) and the Administrative Procedure Act (APA), 5 U.S.C. 556(d),
require consideration of ``all relevant evidence,'' and the Department
therefore cannot exclude from the adjudicator's consideration
noncomplying medical evidence. The Department previously addressed, and
rejected, this argument in the second notice of proposed rulemaking. 64
FR 54974 (Oct. 8, 1999). The Department stated that noncomplying
evidence is not ``relevant evidence'' because it is inherently
unreliable, and cannot form the basis for awarding or denying a claim.
Upon further consideration, the Department concludes this statement,
while accurate in the majority of cases, should be qualified. Evidence
which does not substantially comply with the applicable standard
generally is not very reliable. Noncomplying evidence should only form
the basis for awarding or denying a claim in limited circumstances. All
three of the following requirements must be met: no evidence exists
which does comply with the applicable standards; the defect(s) cannot
be cured by a supplementary opinion or other evidence; and the death of
the miner precludes developing evidence which would be in substantial
compliance. In order for such evidence to support an award or denial,
the adjudicator must find the evidence sufficiently reliable to
establish the fact(s) for which it is offered despite its failure to
meet the threshold ``substantial compliance'' standard. The Department
therefore rejects the commenters' general position that noncomplying
evidence cannot be excluded under 30 U.S.C. 923(b), although the
Department recognizes a limited exception to the standards' gatekeeping
function for some claims involving deceased miners.
(c) Two comments cite specific examples of circumstances in which
allegedly probative physicians' opinions could be disregarded on
compliance grounds. (i) In one example, the commenter cites as
potentially noncomplying a medical opinion diagnosing ``legal''
pneumoconiosis based on valid pulmonary function and arterial blood gas
testing, but omitting any chest x-ray testing. The Department has
previously considered the position that a medical report should not
automatically be found noncomplying based on the absence of an x-ray.
64 FR 54977 (Oct. 8, 1999). In rejecting the comment that the quality
standard applicable to reports of physical examination (Sec. 718.104)
should not make a chest x-ray a standard requirement, the Department
noted that an x-ray is an integral part of any examination for
pneumoconiosis. The Department further noted, however, that medical
evidence must only be in ``substantial compliance'' with the applicable
quality standards; the party proffering the evidence may demonstrate
that the evidence is reliable despite its failure to comply with every
criterion in the standard. The Department reiterates that position.
Whether any particular piece of evidence is in ``substantial
compliance'' with the standards, and therefore reliable, is a matter
for the adjudicator to determine taking into consideration all relevant
circumstances. One important factor is the element(s) of entitlement
for which the evidence is offered. In the example cited above, the lack
of an x-ray is not necessarily fatal. The report may contain: valid and
pertinent other tests and information upon which the physician can make
a diagnosis; accurate medical, smoking and employment histories;
results of a physical examination confirming the
[[Page 79928]]
presence of pulmonary symptoms or impairment; and pulmonary function
study and/or blood gas studies demonstrating impairment. Based on this
documentation, the physician may provide a documented and reasoned
diagnosis of ``legal pneumoconiosis'' which the adjudicator considers
reliable, i.e., in ``substantial compliance'' with the quality
standards. See 45 FR 13687 (Feb. 29, 1980), Sec. 718.202, Discussion
and changes (h). (ii) In another example, the commenter posits a
``positive'' medical opinion based on an invalid pulmonary function
test, valid arterial blood gas testing, physical examination and other
data. The lack of a valid pulmonary function study is not necessarily a
reason to reject the entire report. The hypothetical assumes a valid
blood gas test, physical examination, etc. As in the first example,
this testing and information may support a documented and reasoned
diagnosis depending on the purpose for which the report is offered. If
the physical examination and clinical tests other than the pulmonary
function study substantiate the presence of a pulmonary/respiratory
impairment, the factfinder may deem the physician's diagnosis a
reliable assessment of the miner's extent of impairment. If the
employment, smoking and other personal information is accurate, the
adjudicator may accept the physician's conclusions about the cause of
the miner's pulmonary or respiratory impairment. If, however, the
physician clearly relied on the invalid pulmonary function study (or
other inaccurate data or information), the adjudicator may find the
opinion unreliable in one or more respects. (iii) The Department
emphasizes that the ``substantial compliance'' standard is a rule of
reason. In each case in which an issue of noncompliance is raised, the
factfinder must identify any failure to comply strictly with the
applicable quality standard. The factfinder must then determine whether
the test or report is reliable despite its failure to comply with every
criterion in the standard. This finding is necessarily dependent to an
extent on the element(s) of entitlement for which the test or report
may be relevant. The significance of the particular defect must
therefore be ascertained by considering whether it is critical to the
physician's conclusions. In the first example, the lack of an x-ray may
be excused if the physician has offered a documented and reasoned
diagnosis of ``legal'' pneumoconiosis. In the second example, the
invalid pulmonary function study may or may not affect an otherwise
documented and reasoned evaluation of the miner's respiratory/pulmonary
condition. No categorical response, however, can be given to the
hypotheticals since the reliability, and therefore the probative value,
of the reports can only be evaluated in the context of an actual claim.
No change in the regulation is warranted.
(d) One comment urges the Department to include a provision
specifically exempting those medical tests and reports generated
outside the black lung benefits claim context from the quality
standards. Specifically, the commenter requests that the text of the
regulation make clear that chest x-rays, pulmonary function tests and
blood gas studies administered in the hospital or as part of the
miner's routine care be exempted from quality standards applicability.
The Department previously addressed this concern in the second notice
of proposed rulemaking. 64 FR 54975 (Oct. 8, 1999). The Department
noted that Sec. 718.101 limits the applicability of the quality
standards to evidence ``developed * * * in connection with a claim for
benefits'' governed by 20 CFR parts 718, 725 or 727. Despite the
inapplicability of the quality standards to certain categories of
evidence, the adjudicator still must be persuaded that the evidence is
reliable in order for it to form the basis for a finding of fact on an
entitlement issue. Additional exclusionary language in the regulation
is therefore unnecessary.
(e) One comment contends all medical evidence involving a deceased
miner should be considered without regard to the quality standards
because the miner is no longer available for further testing. The
Department disagrees. The regulations provide that a deceased miner's
noncomplying chest x-rays, pulmonary function studies and medical
reports may form the basis of an award or denial of benefits under
certain circumstances provided no complying study or report is
available. See Secs. 718.102(e) (x-rays), 718.103(c) (pulmonary
function studies), 718.104(c) (medical reports). The Department has
added a similar provision to Sec. 718.105 (arterial blood gas studies).
With respect to each category of evidence, the availability of tests or
reports in substantial compliance with the applicable quality standards
makes reliance on the noncomplying tests or reports unnecessary; the
record already contains reliable evidence addressing the deceased
miner's pulmonary condition, and reliable evidence is the fundamental
purpose of the quality standards. Furthermore, excusing noncompliance
for all evidence involving a deceased miner ignores the fact that
existing evidence may be brought into substantial compliance despite
the unavailability of the miner. The party offering the evidence may
obtain a supplementary opinion from the physician who conducted the
noncomplying test or authored the report, and cure the defect(s).
Finally, the party may submit the noncomplying evidence in any event,
ecognizing that it may be considered but cannot establish any fact for
which complying evidence is in the record.
(f) One comment suggests that applying the quality standards only
prospectively will sanction the acceptance of inferior evidence if the
evidence was developed before the effective date of these regulations.
The commenter also contends the Department's rationale for prospective
application implies the former quality standards will not apply to
evidence developed before the effective date of these regulations,
especially for unrepresented claimants. The Department disagrees. In
the initial notice of proposed rulemaking, proposed Sec. 718.101(b)
required all evidence developed in conjunction with a black lung
benefits claim to comply with the applicable quality standards. 62 FR
3374 (Jan. 22, 1997). The Department stated that the purpose of
Sec. 718.101(b) was to make clear the Department's disagreement with
Benefits Review Board precedent holding the former 20 CFR part 718
quality standards applied only to evidence developed by the Director.
62 FR 3341 (January 22, 1997). One comment, in response to the first
proposal, noted that, as written, Sec. 718.101(b) would invalidate
evidence in claims pending before the Department which was valid under
prevailing Board precedent at the time the evidence was generated. The
Department responded to this concern in the second notice of proposed
rulemaking by revising Sec. 718.101 to apply the quality standards only
to evidence developed after the effective date of the regulations. 64
FR 55010 (Oct. 8, 1999). In explaining the revision, the Department
acknowledged the ``substantial hardship'' which might occur, especially
for unrepresented claimants, if medical evidence which complied with
the law when submitted into evidence became invalid after the
regulations become effective. This explanation, however, is not a
concession as to the correctness of the Board's decisions. Since 1980,
the Department has consistently taken the position that the 20 CFR part
718 quality standards apply to all evidence
[[Page 79929]]
developed by any party in black lung benefits claim litigation.
Although the Board has rejected the Department's position, Gorzalka v.
Big Horn Coal Co., 16 Black Lung Rep. 1-48, 1-51 (1990) (and cases
collected), the only court of appeals to consider the issue has agreed
with the Department. Director, OWCP v. Mangifest, 826 F.2d 1318 (3d
Cir. 1987). The Department adheres to this view with respect to any
evidence developed in conjunction with a claim by any party before the
effective date of the proposed regulations.
(g) Two comments approve of the prospective application of the
quality standards. One comment approves of the ``substantial
compliance'' standard.
(h) No other comments have been received concerning this section,
and no changes have been made in it.
20 CFR 718.102
(a) In the initial notice of proposed rulemaking, the Department
proposed three minor changes to Sec. 718.102: eliminating the reference
to the compliance standard in light of the substantial compliance
language of general applicability in Sec. 718.101(b); adding language
presuming compliance with the technical criteria for chest x-rays in
Appendix A; and correcting a typographical error in subsection (e)
which cited to a nonexistent regulation. 62 FR 3342 (Jan. 22, 1997).
The Department did not propose any additional changes in the second
notice of proposed rulemaking. 64 FR 54971 (Oct. 8, 1999). In the final
rule, the Department has changed subsection (e) to clarify the
probative value of noncomplying x-rays in the case of a deceased miner.
Specifically, this provision states that an x-ray, which is not in
substantial compliance with the quality standard, may still establish
the presence or absence of pneumoconiosis if the x-ray is of sufficient
quality for a board-eligible radiologist, board-certified radiologist,
or ``B'' reader to interpret the film. The Department has also added a
sentence to subsection (b) to inform interested parties where they may
obtain a copy of the ILO classification.
(b) One comment argues that Sec. 718.102(b) should state that an x-
ray cannot establish the absence of pneumoconiosis unless it complies
with the quality standards and is classified according to a recognized
scheme. The commenter further argues that Sec. 718.102(b) and (e), in
conjunction with Sec. 718.101(b), are insufficient to impose this
requirement. Section 718.102(b) identifies the classification systems
which are acceptable for black lung claims. Subsection (e) states that
no x-ray may demonstrate either the presence or absence of
pneumoconiosis unless it complies with reporting requirements, i.e.,
paragraph (b). Section 718.101(b) reinforces this requirement by
stating that ``any evidence'' which is not in substantial compliance
with the applicable quality standard cannot ``establish the fact for
which it is proffered.'' For purposes of the quality standards,
``substantial compliance'' may mean less than strict compliance with
each and every requirement of the applicable quality standard if the
evidence is nevertheless deemed reliable by the factfinder. The
adjudicator must determine whether the x-ray reading is, or is not, in
substantial compliance if one or more items of required information
have been omitted, including classification of x-ray findings according
to any of the reporting schemes in Sec. 718.102(b). In some
circumstances, the adjudicator may determine that the x-ray
interpretation provides sufficient information to make a factual
finding on the presence or absence of pneumoconiosis. For example, the
physician may describe the film findings in terms of ``no
pneumoconiosis,'' rather than classifying the film as ``0/-, 0/0 or 0/
1.'' Such a reading may be considered sufficiently detailed to be in
``substantial compliance'' notwithstanding the lack of classification.
Conversely, the physician's description or reporting of x-ray film
findings may indicate (s)he read the film for reasons unrelated to
diagnosing the existence of pneumoconiosis, e.g., lung cancer or
cardiac surgery. The adjudicator may consider that evidence not in
substantial compliance because it does not reliably address the
presence or absence of pneumoconiosis. Accordingly, the Department
disagrees with the commenter's position that any unclassified x-ray is
not in ``substantial compliance'' with Sec. 718.102.
(c) Four comments suggest adding the phrase ``in and of itself'' to
the subsection (e) prohibition on using unclassified x-rays to
demonstrate the presence or absence of pneumoconiosis. The comments
contend that the change would make clear that x-ray evidence of some
disease process, in conjunction with other evidence, could be used to
prove the miner has a lung disease caused by coal dust exposure, i.e.,
``legal'' pneumoconiosis. The recommended change is unnecessary. An
unclassified x-ray which yields positive indications of lung disease
cannot establish the presence of pneumoconiosis under
Sec. 718.202(a)(1), which is intended as a means of proving only the
existence of clinical pneumoconiosis. An x-ray report, however, may
also be part of a medical report which must be considered under
Sec. 718.202(a)(4). Even an unclassified x-ray may therefore provide
some clinical basis for a diagnosis of a respiratory disease arising
out of coal mine employment under that section. Consequently, provision
is already made for consideration of the results of an unclassified x-
ray in the context of a medical report. In this context, it may be used
to support a diagnosis of legal pneumoconiosis.
(d) No other comments were received concerning this section, and no
other changes have been made in it.
20 CFR 718.103
(a)(i) The Department proposed amending Sec. 718.103 in the initial
notice of proposed rulemaking to take into account proposed
Sec. 718.101(b), which would establish a single standard of
``substantial compliance'' for all of the quality standards. 62 FR 3342
(Jan. 22, 1997). The Department also proposed changes to
Sec. 718.103(c) to harmonize it with Sec. 718.102(e) (X-rays). Both
provisions operate in the same manner and for the same purposes: to
presume compliance with technical requirements in the applicable
appendices to part 718; to permit rebuttal of the presumed compliance
with relevant evidence; and to permit exceptions to the quality
standards for a deceased miner if the claim presents limited evidence.
(ii) In response to comments received concerning the initial notice of
proposed rulemaking, the Department recommended several additional
changes to Sec. 718.103 in the second notice of proposed rulemaking. 64
FR 54975-76 (Oct. 8, 1999). One physician testified at the Washington,
D.C., hearing that a flow-volume loop provided a more acceptable basis
for obtaining verifiable test results than the proposed prohibition on
an initial inspiration from room air. The Department agreed, and
proposed changing both Sec. 718.103 and Appendix B to require flow-
volume loops for every pulmonary function test obtained after the
effective date of the final regulation. The Department invited
additional comment on this proposal. The Department also announced its
intention to survey clinics and facilities which specialize in the
treatment of pulmonary conditions to ascertain the extent to which they
already used spirometers capable of producing flow-volume loops. The
same physician observed that 20 CFR 718.103(a) (1999) required that
pulmonary function
[[Page 79930]]
testing produce either a Forced Vital Capacity (FVC) or a Maximum
Voluntary Ventilation (MVV) result, yet also required a one-second
Forced Expiratory Volume (FEV1) which must be derived from the FVC. The
Department agreed the regulation was inconsistent, and proposed a
revision to Sec. 718.103(a) making the FVC a required result along with
the FEV1 and the MVV optional. The Department also proposed increasing
the allowable difference between the two largest MVV values from 5
percent to 10 percent in Sec. 718.103(b) to harmonize the regulation
with Appendix B. The former and initially proposed Sec. 718.103(b)
required submission of three tracings of the MVV maneuver unless the
two largest MVV results were within 5 percent of each other, in which
case only two tracings were necessary. By contrast, Appendix B has
consistently stated that the variation between the two largest MVV
shall not exceed 10 percent. The Department chose the more liberal
variation. The Department agreed that the validity of the MVV and FEVl/
FVC values must be assessed independently, and that the MVV maneuver is
optional for compliance purposes. The Department, however, rejected the
suggestion to remove certain technical requirements from the quality
standards to avoid invalidating a pulmonary function test for less than
strict compliance; the Department responded that the ``substantial
compliance'' standard would allow a party to establish the credibility
of the study, notwithstanding the absence of one or more of the
Sec. 718.103 requirements. Finally, the Department proposed revisions
to Secs. 718.104(a)(6) and 718.204(b)(2)(iv) to recognize that a
medical report cannot be rejected for lack of a pulmonary function
study if the performance of the test was medically contraindicated.
(iii) For the final rule, the Department has changed the word
``submitted'' in Sec. 718.103(b) to ``developed'' to conform the
regulation to similar usage in Sec. 718.101(b). The Department also
changed the opening phrase of the first sentence in Sec. 718.103(c) to
clarify that paragraph (c) is an exception to the remainder of
Sec. 718.103. Finally, the Department amended the final sentence in
subsection (c) to make clear that a noncomplying pulmonary function
test involving a deceased miner may be used to establish the presence
or absence of a respiratory or pulmonary impairment under limited
circumstances. If no complying test is in the record and, in the
adjudicator's opinion, the noncomplying test yielded technically valid
results and the miner provided good cooperation, the party submitting
the noncomplying test may rely on it.
(b) The Department announced its intention in the second notice of
proposed rulemaking to conduct a survey of the physicians, clinics and
facilities which perform pulmonary function testing (spirometry
testing) to evaluate the prevalence of spirometers capable of producing
a flow-volume loop. The Department considered the survey necessary in
light of its conclusion that the flow-volume loop may provide a ``more
reliable method of ensuring valid, verifiable results in pulmonary
function testing.'' 64 FR 54975 (Oct. 8, 1999). The Department also
cited the relatively inexpensive cost (approximately $2000) for a
spirometer capable of producing the flow-volume loop. The Department
sent out the survey, dated March 7, 2000, to approximately 1800
pulmonary clinics, facilities and physicians board-certified in
internal medicine with a subspecialty in pulmonary disease (Rulemaking
Record Ex. 107), and received 225 responses (Rulemaking Record Ex.
109). Of those responses, only nine indicated they did not perform
pulmonary function testing on equipment producing a flow-volume loop.
Of those nine, five indicated they would consider obtaining the
necessary equipment. An additional 19 surveys did not respond to the
questions concerning spirometric testing. The remaining respondents,
197 in all, unanimously used the flow-volume loop. Based on these
survey results, the Department concludes the benefit to the claims
adjudication process in obtaining reliable pulmonary function data
warrants revising Sec. 718.103(a) and Appendix B to make the flow-
volume loop a mandatory requirement for any pulmonary function test
conducted after the effective date of these regulations in connection
with a claim for benefits under the Black Lung Benefits Act (BLBA).
(c) One comment opposes the flow-volume loop requirement because
spirometric equipment which records this data may not be universally
available. The Department disagrees. In the second notice of proposed
rulemaking, the Department proposed using the flow-volume loop because
it provides a reliable and relatively inexpensive means of producing
valid, verifiable pulmonary function test results. 64 FR 54975 (Oct. 8,
1999). The Department's survey of physicians, clinics and facilities
which perform pulmonary function testing confirmed the widespread use
of spirometers capable of producing flow-volume loops. Although some
clinics and individual physicians may not utilize such machines, the
Department has concluded that the overall benefit to the claims
adjudication process warrants required use of this technology. In any
event, the claimant should always have access to one set of testing
which complies with the quality standards, including the flow-volume
loop requirement, as a result of the pulmonary examination authorized
by 30 U.S.C. 923(b). This provision of the BLBA requires the Black Lung
Disability Trust Fund to afford each miner-claimant the opportunity to
substantiate his or her claim by means of a complete pulmonary
examination at no expense to the claimant. See also Sec. 725.406(a).
Under Sec. 725.406(c), the district director is responsible for
ensuring that the examination authorized by 30 U.S.C. 923(b) is in
``substantial compliance'' with the requirements of part 718, including
the quality standards. Section 725.406(d) requires the Department to
make available to the claimant's physician, on the claimant's request,
the clinical test results obtained in conjunction with the pulmonary
examination. Thus, contrary to the commenter's concern, the claimant's
physician should routinely be able to consider substantially complying
clinical testing of the miner in formulating an opinion, despite the
lack of capable technology in his or her own practice.
(d) One comment approves of the Sec. 718.103 revisions generally,
and particularly approves of the language making clear that the Maximum
Voluntary Ventilation maneuver is optional. One comment supports the
use of flow-volume loops and changes to Sec. 718.103(a) which eliminate
internal inconsistencies and clarify that the Maximum Voluntary
Ventilation maneuver is optional. One comment approves of requiring
pulmonary function test results using flow-volume loops and the
increase from 5 percent to 10 percent in the maximum variation between
the two largest MVV values.
(e) No other comments were received concerning this section, and no
other changes have been made in it.
20 CFR 718.104
(a)(i) The Department proposed several changes to Sec. 718.104 in
the initial notice of proposed rulemaking. 62 FR 3342-43, 3375 (Jan.
22, 1997). One change required that each medical opinion developed in
connection with a claim be based on specified tests and information,
including a chest x-ray and pulmonary function study which comply with
the applicable quality standards. Another change proposed
[[Page 79931]]
guidelines for the adjudicator to determine whether to afford special
weight to an opinion from the miner's treating physician. The
Department considered codification of the treating physician's special
status appropriate, given its longstanding judicial recognition in the
caselaw. In order to ensure a critical analysis of the physician-
patient relationship, the guidelines described four basic factors the
adjudicator must consider: whether the physician provided pulmonary or
non-pulmonary treatment; how long the physician treated the miner; how
often the physician treated the miner; and what types of tests and
examinations the physician conducted. Finally, the Department
emphasized that the adjudicator must consider not only the quality of
the physician's relationship with the miner, but also the reasoning and
documentation in the opinion itself, and in the context of the
remainder of the record, before crediting that opinion. (ii) In the
second notice of proposed rulemaking, the Department responded to the
extensive comments which the proposed regulation had elicited. 64 FR
54976-77 (Oct. 8, 1999). The Department revised the regulation to
excuse mandatory pulmonary function testing if it was medically
contraindicated and the physician conducted other types of medically
accepted diagnostic tests; to make explicit that a treating physician's
opinion could be used to establish all elements of a miner's
entitlement; and to accept the physician's statement as to subsection
(d)'s treating relationship criteria, absent contrary evidence from
another party. The Department rejected comments which advocated the
automatic acceptance of a treating physician's opinion if it satisfied
the criteria of subsections (d)(1) through (5) and was documented and
reasoned, regardless of the remaining medical evidence. The Department
also rejected one comment which contended the regulation already
mandated the automatic acceptance of a treating physician's opinion in
violation of 30 U.S.C. 923(b) (requiring consideration of all relevant
evidence). In response, the Department emphasized that Sec. 718.104(d)
only required the adjudicator to consider the possible enhanced value
of a treating physician's opinion, and did not require a mechanistic
acceptance of that opinion. The Department responded in similar fashion
to several comments which contended that all medical opinions,
including a treating physician's opinion, should be evaluated only on
the strength of their documentation and reasoning and each physician's
professional qualifications. With respect to a comment recommending
placement of the treating physician rule in a separate regulation, the
Department concluded no change was warranted; subsection (d)'s position
in the quality standards governing reports of physician examinations
underscored that a treating physician's opinion was required to satisfy
the same quality standards as any other physician examination report
developed in connection with a claim for benefits. The Department
acknowledged some commenters' concern that unrepresented claimants
would likely submit noncomplying reports from their treating
physicians. The Department, however, rejected the suggestion that
treating physicians' opinions should be exempted from the evidentiary
limitations for that reason. Instead, the Department noted its own
obligation to inform claimants in an understandable manner about the
evidentiary limitations, and to provide any claimant's treating
physician with the results of the Sec. 725.406 objective testing upon
the claimant's request. The Department denied one comment's suggestion
that language in the initial notice of proposed rulemaking (see 62 FR
3339 (Jan. 22, 1997)) made an adjudicator's failure to consider a
physician's training and specialization reversible error. In the
Department's view, a physician's qualifications were an issue only when
raised by a party. The Department also rejected the suggestion that a
chest x-ray, administered and read in accordance with Sec. 718.102, not
be mandatory documentation for a complying report of physical
examination. The Department cited the importance of such a diagnostic
test and the flexibility of the ``substantial compliance'' standard in
excusing noncompliance depending on the particular circumstances of the
case. In response to two comments, the Department declined to remove a
limitation on the use of noncomplying medical opinions. The regulation
therefore allowed consideration of reports of physical examination not
in substantial compliance with Sec. 718.104 only if the miner was
deceased, the physician was unavailable to cure the defects in the
report, and there was no complying report in the record. In
explanation, the Department emphasized that entitlement decisions must
be based on the best available evidence. Finally, the Department
invited additional public comment on alternative means of determining
when a treating physician's opinion should receive ``controlling
weight,'' including whether the Department should adopt the Social
Security Administration's rule. (iii) For purposes of the final rule,
the Department has altered subsection (c) to conform this provision to
the general ``substantial compliance'' standard in Sec. 718.101(b). As
amended, Sec. 718.104(c) makes clear that a noncomplying report of
physical examination may nevertheless provide evidence for a factual
finding in certain limited circumstances involving a deceased miner and
the lack of any complying report of physical examination in the record.
The report must have been prepared by a physician who is
``unavailable,'' e.g., deceased, whose whereabouts are unknown, etc.
The report must also be found to possess sufficient indicia of
reliability that the adjudicator may reasonably rely on it for factual
findings.
(b) Several comments oppose granting special weight to the opinion
of a miner's treating physician, contending the rule either intrudes on
the adjudicator's role in evaluating evidence or compels the acceptance
of an opinion from the treating physician regardless of contrary
opinions from physicians with greater expertise in pulmonary medicine.
The Department responded to a similar criticism in the second notice of
proposed rulemaking. 64 FR 54976 (Oct. 8, 1999). In rejecting a
commenter's view that Sec. 718.104(d) effectively precluded
consideration of all relevant evidence in favor of the opinion of the
miner's treating physician, the Department emphasized the real purpose
of the rule: to recognize that a physician's professional relationship
with the miner may enhance his or her insight into the miner's
pulmonary condition. The Department does not believe that, as proposed,
section 718.104(d) contained an outcome-determinative evidentiary rule.
See 64 FR 54977 (Oct. 8, 1999). The Department has revised the language
of section 718.104(d), however, in light of several commenters'
continued confusion as to the role of Sec. 718.104(d) in weighing
reports of physical examinations. The Department hopes to clarify its
original intent with this revision. Like the previously proposed
version, subsection (d) acknowledges the special weight which the
opinion of a miner's treating physician may receive from the
adjudicator. Section 718.104(d)(1)-(4) provide criteria for evaluating
the quality of that doctor-patient relationship as indicia of the
potential insight the physician may have gained from on-going treatment
of the miner.
[[Page 79932]]
Instead of compelling the automatic acceptance of the treating
physician's opinion, section 718.104(d) is designed to force a careful
and thorough assessment of the treatment relationship. The adjudicator
may conclude that no additional weight is due the physician's opinion
because one or more of the criteria establish facts which make such
weight inappropriate. For example, the physician may have provided only
a short-term course of treatment, or have actually examined the miner
only infrequently. The adjudicator should consider giving additional
weight to the treating physician's opinion only when review of the
regulatory criteria establishes the physician's thorough understanding
of the miner's pulmonary condition. Subsection (d)(5) describes the
next step in the adjudicator's inquiry: the adjudicator must consider
whether the treating physician's opinion is supported by sufficient
documentation and reasoning, and must weigh it with all other reasoned
and documented medical opinions in the record. In addition, the fact
finder must consider all other relevant evidence of record. The
regulation provides that only after the adjudicator finishes this
weighing may he, in appropriate cases, base his decision to give
``controlling weight'' to the opinion of the miner's treating physician
on that physician's superior understanding of the miner's pulmonary
condition. The Department recognizes that each case will present
different issues regarding both the extent to which the treating
physician meets the four criteria in subsection (d)(1)-(4), the
documentation and reasoning of that physician's opinion, and the
relative merits of the other relevant medical evidence of record. As a
result, the regulation does not attempt to dictate the outcome of any
particular case. The Department therefore rejects the position that
Sec. 718.104(d) intrudes on the fact-finding responsibilities of the
adjudicator.
(c) One comment opposes requiring each physician's opinion to
include an x-ray or pulmonary function study conducted according to the
applicable quality standards. The commenter suggests these tests are
not always necessary for a relevant and credible opinion, and cites
three examples: (i) A physician diagnoses an obstructive lung
impairment based on valid pulmonary function testing, examination,
etc., but does not obtain an x-ray. With respect to the mandatory x-ray
requirement, the Department has previously addressed this argument in
the second notice of proposed rulemaking, 64 FR 54977 (Oct. 8, 1999),
and reiterates its position in responding to comments under
Sec. 718.101 of this rule. X-rays are an integral part of any informed
and complete pulmonary evaluation of a miner; a general requirement for
inclusion of this test is therefore appropriate. The Department also
notes, however, that the quality standards require only ``substantial
compliance'' with the various criteria, not technical compliance with
every criterion in every quality standard in every case. A factfinder
may conclude the omission of an x-ray does not undermine the overall
credibility of the opinion, but this determination must be made on a
case-by-case basis. The same commenter poses this example in the
context of Sec. 718.101. The Department's response to that hypothetical
makes certain critical assumptions in concluding the physician's
opinion may be found in ``substantial compliance'' with the quality
standards: the valid pulmonary function study demonstrates the presence
of a pulmonary/respiratory impairment; the physician's examination of
the miner identifies signs or symptoms of a pulmonary condition; and
the physician has an accurate understanding of the miner's employment,
smoking and personal histories. If the clinical tests and other
information provide a documented basis for a reasoned and reliable
opinion, the factfinder may find the diagnosis of ``legal
pneumoconiosis'' in ``substantial compliance'' with Sec. 718.104
despite the absence of the x-ray. (ii) A physician finds complicated
pneumoconiosis on an x-ray, but does not conduct a pulmonary function
test. One means of diagnosing complicated pneumoconiosis is by x-ray.
30 U.S.C. 921(c)(3)(A). The x-ray evidence is relevant to
Secs. 718.202(a)(3) and 718.304(a); accordingly, Sec. 718.102 provides
the applicable quality standards, and not Sec. 718.104. The lack of a
pulmonary function study does not affect the probative value of the x-
ray reading(s) as evidence of complicated pneumoconiosis under 30
U.S.C. 921(c)(3)(A), because a pulmonary function study is not relevant
to that means of invoking the irrebuttable presumption. Although all
relevant evidence must be weighed in determining whether the miner has
complicated pneumoconiosis, Melnick v. Consolidation Coal Co., 16 Black
Lung Rep. 1-31, 1-33 (1991), the evidence must pertain to the means of
diagnosing or refuting the existence of complicated pneumoconiosis as
provided by 30 U.S.C. 921(c)(3)(B) and (C). Cf. Double B Mining v.
Blankenship, 177 F.3d 240, 243 (4th Cir. 1999) (holding factfinder must
determine whether evidence relevant to each method of invoking
irrebuttable presumption is ``equivalent,'' and establishes same
underlying condition). The physician's report may provide additional
valuable insight into his or her reasons for interpreting the x-ray as
positive for complicated pneumoconiosis rather than some other
condition detectable by x-ray; to that extent, the report may be
relevant to weighing the credibility of the x-ray evidence. As a report
of physical examination, however, the hypothetical report does not
satisfy the ``substantial compliance'' standard. (iii) In his report of
physical examination, a physician relies in part on a noncomplying
pulmonary function test, but another complying test yields comparable
results. Again, ``substantial compliance'' is a test of evidentiary
reliability based on all relevant circumstances of the particular case.
The factfinder must evaluate those circumstances and determine whether
the specific omission undermines the credibility of the evidence. In
the hypothetical, the factfinder must consider not only the defects in
the physician's pulmonary function study, but also the remaining
documentation in the report (other clinical studies, the miner's
employment, smoking and personal information, etc.). If the report
otherwise complies with Sec. 718.104, the invalid pulmonary function
study may be mitigated by the presence of a complying study which
confirms the physician's interpretation of the invalid study.
(d) One comment supports the revision of Sec. 718.104(a)(6) in the
second notice of proposed rulemaking, which exempts a miner from
mandatory pulmonary function testing if the test is medically
contraindicated, and allows a physician preparing a report of physical
examination to substitute other medically acceptable clinical and
laboratory diagnostic techniques in support of his conclusions. 64 FR
54976, 55011 (Oct. 8, 1999).
(e) One comment recommends the Department delete the conditions in
Sec. 718.104(c) that, in the case of a deceased miner, limit the
consideration of a report from a physician who is not available if the
report is not in substantial compliance with the quality standards.
This provision permits the adjudicator to base a finding on such
evidence only if the record does not contain any physician's report
which is in substantial compliance. No change in the regulation is
necessary. Although ``substantial compliance'' is a flexible
[[Page 79933]]
concept, it is also necessary to ensure that claims are adjudicated
using the most reliable evidence available. Consequently, the
Department has incorporated limitations throughout the quality
standards on the use of noncomplying evidence in claims involving
deceased miners in which there is no complying evidence of record. The
fact that a miner is deceased is not necessarily a bar to
rehabilitating noncomplying evidence. With respect to reports of
physical examination, the physician who is available to review and
further comment on his or her own report may cure the defect and bring
the report into substantial compliance. If, however, the physician is
unavailable, Sec. 718.104(c) permits noncomplying evidence to be
considered if there is no complying evidence of record. The Department
believes noncomplying evidence should be used to establish facts about
a deceased miner's condition only when no practical alternative is
available. As long as complying evidence or the means of achieving
compliance exist, noncomplying evidence should not be the basis for
determining the validity of a claim.
(f) One comment objects to the retroactive application of the
changes made to Sec. 718.104. None of these changes, however, apply
retroactively. Section 718.101(b) provides that the ``standards for the
administration of clinical tests and examinations'' will govern all
evidence developed in connection with benefits claims after the
effective date of the final rule. Section 718.104 contains the quality
standards for any ``[r]eport of physical examinations,'' including
reports prepared by a miner's treating physician. Physicians' medical
reports are expressly included in the terms of Sec. 718.101(b).
Consequently, the changes to Sec. 718.104 apply only to evidence
developed after the effective date of the final rule. With respect to
treating physicians' opinions developed and submitted before the
effective date of the final rule, the judicial precedent summarized in
the Department's initial notice of proposed rulemaking continues to
apply. See 62 FR 3342 (Jan. 22, 1997). These decisions recognize that
special weight may be afforded the opinion of a miner's treating
physician based on the physician's opportunity to observe the miner
over a period of time.
(g) Two comments state the ``treating physician'' rule has no
scientific basis because a treating physician is in no better position
than any other physician to assess a miner's pulmonary status. The
commenters note that a primary care physician will often, as a matter
of medical practice, refer an individual to a physician with particular
training for specialized care; the primary care provider may therefore
have little, if any, qualified understanding of the patient's health
problems. The commenters also state that the essential basis for a
reasoned diagnosis is valid objective testing and sound interpretation
of the data rather than patient complaints and physical examinations.
Finally, the commenters conclude that frequency of contact alone does
not provide any advantage for a physician in developing a comprehensive
understanding of the patient's condition. The commenters' concerns do
not provide a basis for abandoning the rule. First, the miner's
``treating physician'' is not necessarily the physician with whom the
miner has a long-standing generalized relationship if another physician
actually provides specialized treatment for respiratory or pulmonary
problems. If the miner's primary care provider refers the miner to a
pulmonary specialist for treatment, then that specialist may be
considered the miner's ``treating physician'' for purposes of his or
her pulmonary condition. If, however, the specialist provides an
opinion to the primary care physician which forms the basis for the
miner's treatment by the latter, the primary care physician's opinion
is strengthened by reliance on the specialist's expertise. Second, the
Department agrees that valid clinical testing and a reasoned medical
report are necessary prerequisites for a credible medical opinion. A
treating physician's opinion is subject to the Department's quality
standards, which require the report to be based on specific clinical
tests, findings and other data and information. See Sec. 718.104(a)(l)-
(6). A treating physician's report must be reasoned as well as
documented (Sec. 718.104(d)(5)). In this regard, a treating physician's
opinion is no different than any other physician's opinion developed in
connection with a claim for benefits. The Department does not intend to
displace the long-standing judicial precedent that sanctions the
rejection of a treating physician's report if it fails the basic
requirements for credible evidence. See, e.g., Sterling Smokeless Coal
Co. v. Akers, 131 F.3d 43 8, 441 (4th Cir. 1997); Lango v. Director,
OWCP, 104 F.3d 573, 577 (3d Cir. 1997); Peabody Coal Co. v. Helms, 901
F.2d 571, 573-74 (7th Cir. 1990); see generally Halsey v. Richardson,
441 F.2d 1230, 1236 (6th Cir. 1971) (rejecting ``a mechanical rule
insulating a treating doctor's opinion from attack, no matter how
respectable and persuasive may be opposing opinions by doctors who
examined a claimant on only one occasion''). As for the commenters'
statement that the frequency of patient contact provides no advantage
to a physician, this view is too simplistic. Frequency of treatment is
only one of the regulatory criteria (Sec. 718.104(d)(3)) the
adjudicator must consider in assessing the treating physician
relationship. The number of visits must be viewed in the context of the
other criteria (nature of relationship, duration of relationship, type
and extent of treatment). The totality of the information demanded by
the criteria establishes the overall quality of the doctor-patient
relationship, which guides the adjudicator in determining whether to
accord the treating physician's opinion controlling weight. The
comments do not state a basis for changing or eliminating the
``treating physician'' rule.
(h) Two comments contend the ``treating physician'' rule creates an
``evidentiary preference'' which violates section 7 of the
Administrative Procedure Act (APA), 5 U.S.C. 556. Although the Social
Security Administration (SSA) has also promulgated a regulation, 20 CFR
404.1527(d) (1999), addressing the weight to be given a treating
physician's opinion, the commenters argue there is no adverse party in
SSA claims, and the APA does not apply to SSA claims adjudication. By
implication, the commenters suggest the Department cannot adopt a
``treating physician'' rule comparable to the SSA model, or any rule
which affords special weight to a treating physician's opinion. The
Department disagrees. As an initial matter, whether the APA does or
does not apply to SSA claims adjudications is irrelevant to evaluating
the validity of Sec. 718.104(d). The Supreme Court has expressly
refused to resolve the issue because ``the social security
administrative procedure does not vary from that prescribed by the APA.
Indeed, the latter is modeled upon the Social Security Act.''
Richardson v. Perales, 402 U.S. 389, 409 (1971). In any event, the
commenters misapprehend both the nature of Sec. 718.104(d) and the
critical differences between that regulation and the SSA version. The
commenters describe the ``treating physician'' rule as an ``evidentiary
preference.'' The Department interprets this phrase to characterize the
rule as a burden-shifting presumption which imposes on the party
opposing the claim the burden to overcome the ``preference'' for the
treating physician's opinion. The Department, however, has repeatedly
emphasized in the second
[[Page 79934]]
notice of proposed rulemaking and its responses to comments in this
rule that Sec. 718.104(d) does not create a presumption in favor of the
treating physician's opinion. See 64 FR 54976-77 (Oct. 8, 1999). The
regulation provides a set of criteria to guide the adjudicator's
evaluation of the treating physician's professional relationship with
the miner, and ensure a critical and thorough factual determination
whether that opinion should ultimately be given ``controlling weight.''
Aside from assessing the strength or weakness of the treating
physician's report, the adjudicator must also weigh that report against
all other relevant evidence in the record. Consequently,
Sec. 718.104(d) is not a strict, outcome-determinative rule like more
traditional evidentiary presumptions. These characteristics also
distinguish Sec. 718.104(d) from SSA's version in 20 CFR 404.1527(d).
Both regulations state that ``controlling weight'' may be given to a
treating physician's report. Section 404.1527(d), however, provides
that ``[g]enerally, we give more weight to opinions from your treating
sources, * * *.'' 20 CFR 404.1527(d)(2) (1999). This language
demonstrates an affirmative preference for reports from treating
physicians; Sec. 718.104(d) is more qualified in permitting
``controlling weight'' only if the regulatory criteria warrant it.
Another significant difference between the regulations is the role the
criteria play in determining the weight given the medical evidence.
Section 404.1527(d) makes the criteria relevant only after the
adjudicator refuses to give the treating physician ``controlling
weight:'' ``Unless we give a treating source's opinion controlling
weight * * * we consider all of the following factors in deciding the
weight we give to any medical opinion.'' The regulation lists several
criteria which are similar to those listed in Sec. 718.104(d)(l)-(4).
Section 718.104(d) makes the same criteria the basis for determining in
the first place whether to give the treating physician controlling
weight. To the extent 20 CFR 404.1527(d) operates like an evidentiary
presumption, it does not affect the validity of Sec. 718.104(d) because
Sec. 718.104(d) clearly is not a presumption in favor of the treating
physician's opinions. Accordingly, the Department rejects the
commenters' position that the rule violates the APA.
(i) Three comments oppose the requirement in Sec. 718.104(d)(5)
that the adjudicator must weigh a treating physician's opinion against
the contrary relevant evidence in the record. One comment states that
affording a treating physician's opinion ``controlling weight'' is
meaningless unless the adjudicator may accept the opinion despite a
reasoned and documented contrary opinion by a pulmonary specialist
submitted by another party; otherwise, according to the commenter, a
treating physician's opinion will prevail only when it echoes similar
opinions from other physicians. Another comment interprets subsection
(d) as a burden-shifting device which affords the treating physician's
opinion presumptive controlling weight unless the opposing party
overcomes that opinion by a preponderance of the evidence. The
Department has previously responded to comments contending that a
treating physician's opinion should receive conclusive weight once the
adjudicator reviews the opinion in light of the criteria enumerated in
subsection (d)(1)-(4). 64 FR 54976 (Oct. 8, 1999). The Department
rejected this position because it artificially limits the adjudicator's
consideration of the evidence, and may promote a mechanistic and
uncritical acceptance of the treating physician's opinion at the
expense of more credible contrary evidence. No basis for departing from
this position is established by the new comments. The Department
emphasizes that the ``treating physician'' rule guides the adjudicator
in determining whether the physician's doctor-patient relationship
warrants special consideration of the doctor's conclusions. The rule
does not require the adjudicator to defer to those conclusions
regardless of the other evidence in the record. The adjudicator must
have the latitude to determine which, among the conflicting opinions,
presents the most comprehensive and credible assessment of the miner's
pulmonary health. For the same reasons, the Department does not
consider subsection (d) to be an evidentiary presumption which shifts
the burden of production or persuasion to the party opposing
entitlement upon the submission of an opinion from a miner's treating
physician. Accordingly, the Department declines to eliminate the
requirement in subsection (d)(5) that a treating physician's opinion
must be considered in light of all relevant evidence in the record.
(j) One comment objects to comparing a treating physician's
qualifications to those of any other physician in the record. The
commenter suggests comparative qualifications may provide a basis for
refusing controlling weight to the treating physician's opinion if
another physician has superior credentials. The Department responded to
a similar comment in the second notice of proposed rulemaking, and
noted that professional credentials are only one factor the adjudicator
may consider in weighing medical opinions. 64 FR 54977 (Oct. 8, 1999).
No basis exists, however, for insulating the treating physician from a
consideration of his or her qualifications, or prohibiting giving
additional weight to the opinion of a physician with specialized
training in a relevant area of medicine. Although expertise is only one
of several potentially relevant factors to consider, it is nonetheless
a significant consideration. See, e.g., Milburn Colliery Co. v. Hicks,
138 F.3d 524, 536 (4th Cir. 1998). Furthermore, the commenter's concern
over comparative qualifications overlooks an important consideration
underlying the ``treating physician'' rule. In black lung benefits
claims, the principal issue ordinarily is the miner's pulmonary
condition. The treating physician may develop a more in-depth knowledge
and understanding of that issue than a physician with greater academic
credentials and minimal, or nonexistent, contact with the miner. The
purpose of the Sec. 718.104(d) criteria is to enable the adjudicator to
determine whether the treating physician has such informed knowledge
that his or her opinion merits special weight.
(k) One comment suggests a consultative physician's opinion should
receive the same weight accorded a treating physician if the consultant
relies on the treating physician's report, the results of clinical
tests, medical records, etc., and the consulting report satisfies the
Sec. 718.104(d) criteria. The Department rejects this suggestion. If
any physician (other than the treating physician) could receive
enhanced weight by incorporating consideration of the treating
physician's opinion into his or her consulting opinion, the
consultative physician(s) for each party would stand on equal footing
based on access to the treating physician's report. No reason would
therefore exist for the rule. In any event, a consultative physician's
reliance on the treating physician's report does not necessarily confer
the same benefit the treating physician may derive from the nature,
duration, frequency and extent of treatment during the physician-
patient relationship with the miner.
(l) Two comments oppose making the quality standards applicable to
the report of physical examination prepared by a miner's treating
physician. The commenters suggest removing subsection (d) from
Sec. 718.104 and making it a separate regulation. The Department
rejected the identical
[[Page 79935]]
argument in the second notice of proposed rulemaking. 64 FR 54976-77
(Oct. 8, 1999). The Department intends the quality standards to apply
to any physician's report developed in connection with a claim for
benefits, including any report prepared by a treating physician.
Although a treating physician may have a superior perspective on the
miner's health in certain circumstances, status alone does not
guarantee the validity of the physician's opinion.
(m) Two comments recommend allowing a miner or a miner's family
members to attest to the nature of the miner's relationship with his or
her treating physician. The Department disagrees. Although persons
other than the physician may have some direct knowledge of the miner's
treatment, only the physician can provide a complete picture of the
doctor-patient relationship, as well as documentary evidence of the
specific clinical tests conducted. In addition, if representations as
to the criteria in (d)(1) through (4) are challenged, it is the
physician's records, including treatment notes, etc., which will enable
the adjudicator to evaluate the quality of the relationship. Evidence
from persons other than the physician may supplement the physician's
characterization of the miner's treatment, but the physician (or the
physician's records) remains the best primary source for depicting the
miner's treatment.
(n) In the second notice of proposed rulemaking, the Department
invited comment on alternatives to the revised ``treating physician''
rule, including whether to adopt a version of the rule comparable to
the Social Security Administration's (SSA) regulation, 20 CFR
404.1527(d) (1999). 64 FR 54976 (Oct. 8, 1999). (i) Two comments oppose
in general terms using the SSA regulation to evaluate the treating
physician's opinion. (ii) One comment recommends incorporating language
from the SSA regulation that more weight should ``generally'' be given
a miner's treating physician. See 20 CFR 404.1527(d)(2) (1999). The
commenter opposes any other use of the SSA regulation. The additional
language is inappropriate. See paragraph (h), above. Section 718.104(d)
outlines the circumstances in which a treating physician may be
afforded ``controlling weight'' on entitlement issues. Although the
regulation recognizes the special value which may attach to a treating
physician's report in certain circumstances, the Department does not
intend to deflect attention from the necessity for critical examination
of the physician's reasoning and documentation. The Department has
previously explained the intended limits of section 718.104(d) as an
evidentiary rule which guides consideration of a treating physician's
opinion but does not impose a strict outcome. 64 FR 54977 (Oct. 8,
1999). The recommended additional language does not further this
purpose. Accordingly, the recommendation is rejected. (iii) No comment
recommended adopting the SSA regulation in place of the regulation as
proposed by the Department.
(o) Several comments approve generally of the ``treating
physician'' rule.
(p) No other comments were received concerning this section, and no
other changes have been made in it.
20 CFR 718.105
(a)(i) In the initial notice of proposed rulemaking, the Department
proposed amending Sec. 718.105 to address arterial blood gas studies
which are administered during a miner's terminal hospitalization, i.e.,
``deathbed'' studies. 62 FR 3342-43 (Jan. 22, 1997). Specifically, the
Department expressed concern that such studies may produce qualifying
values for reasons unrelated to chronic pulmonary disease. The
Department therefore suggested a new requirement that a claimant must
submit a physician's report linking the blood gas study results to a
chronic pulmonary condition caused by exposure to coal mine dust in
order to rely on the qualifying results as evidence of total
disability. 62 FR 3375 (Jan. 22, 1997). (ii) In response to comments
received, the Department deleted the requirement that, in the case of
blood gas studies administered during a hospitalization that ends in
the miner's death, the chronic pulmonary condition must be shown to be
related to the miner's exposure to coal mine dust; the Department
agreed the causation requirement was inappropriate because Sec. 718.105
addresses the existence of a chronic pulmonary impairment, and not its
source. 64 FR 54977-78 (Oct. 8, 1999). The Department also agreed to a
minor change in technical nomenclature by changing ``p'' to ``P'' to
denote partial pressure. Finally, the Department rejected those
comments which opposed requiring the claimant to establish a link
between a miner's ``deathbed'' blood gas study and a chronic pulmonary
condition. The Department concluded the proposed requirement was
necessary because the miner's qualifying test results during a terminal
hospitalization may be related to an acute non-pulmonary condition
rather than a chronic pulmonary impairment. 64 FR 54977 (Oct. 8, 1999).
(b) One comment recommends the Department afford consideration to
noncomplying blood gas studies in the case of a deceased miner since
such consideration is given elsewhere in the regulations for x-rays
(Sec. 718.102(e)) and pulmonary function studies (Sec. 718.103(c)). The
regulations also outline specific circumstances under which a report of
physical examination of a miner now deceased may be considered by an
adjudication officer notwithstanding its failure to substantially
comply with Sec. 718.104(a) and (b). See Sec. 718.104(c), above. The
Department agrees, and has revised Sec. 718.105 accordingly by adding
subsection (e). This provision is comparable to Sec. 718.103(c), and
permits the adjudicator to consider a deceased miner's blood gas
studies not in substantial compliance with subsections (a), (b) and (c)
if they are the only available tests and, in the adjudicator's opinion,
are technically valid. Subsection (e) also requires any such test to
meet the requirements of subsection (d) if the test was obtained during
a miner's hospitalization ending in death and yielded qualifying
values. The claimant must submit a physician's opinion establishing
that the qualifying values reflect a chronic pulmonary impairment and
not some acute condition unrelated to a chronic pulmonary impairment.
(c) Two comments oppose requiring the claimant to prove a miner's
chronic respiratory or pulmonary impairment caused his qualifying
``deathbed'' blood gas results. The commenters argue that the party
opposing entitlement should bear the burden of proving a non-
respiratory or non-pulmonary condition caused the qualifying results
since that party has equal access to the miner's hospital records and
physicians. The Department disagrees. The claimant bears the general
burden of persuasion to establish entitlement to benefits by a
preponderance of the evidence, except to the extent a presumption eases
that burden. See generally Director, OWCP v. Greenwich Collieries, 512
U.S. 267 (1994). One facet of the claimant's burden is the
responsibility to ensure that the clinical tests such as blood gas
studies substantially comply with the quality standard. The quality
standard provides some assurance to the adjudicator that the clinical
test is valid, accurate and reliable evidence of the factual
proposition for which it is proffered. The Department considers a
physician's opinion necessary to establish a nexus between ``deathbed''
[[Page 79936]]
blood gas studies and a chronic pulmonary disease; raw clinical test
results under these circumstances are not sufficiently instructive for
a lay adjudicator to make such a determination. The fact that the party
opposing entitlement may have equal access to relevant information
about the circumstances and interpretation of the blood gas testing is
not determinative in allocating the burden of persuasion. The
Department does not perceive any basis for shifting the overall burden
of proof from the claimant to the opposing party in the case of
qualifying ``deathbed'' blood gas studies. The comments do not address
the Department's explanation in the second notice of proposed
rulemaking, 64 FR 54977-78 (Oct. 8, 1999), for imposing this
requirement, beyond noting continued opposition. The Department
therefore rejects the comments' position.
(d) No other comments were received concerning this section, and no
other changes have been made in it.
20 CFR 718.106
(a) The Department proposed minor changes to Sec. 718.106 in the
initial notice of proposed rulemaking to account for the adoption of a
general standard of substantial compliance with the quality standards
(Sec. 718.101), and to adopt consistent terminology for evidence which
is not in substantial compliance with the applicable standard. 62 FR
3343 (Jan. 22, 1997). The Department responded to several comments in
the second notice of proposed rulemaking. 64 FR 54978 (Oct. 8, 1999).
At the urging of several commenters, the Department restored subsection
(c) to Sec. 718.106, explaining that the omission of that provision
from the initial proposed version of the regulation was inadvertent.
Other comments expressed concern that the requirement for a gross
macroscopic inspection of the lungs would preclude reliance on
reviewing physicians, who ordinarily review only the autopsy protocol
and inspect tissue samples microscopically. The Department responded
that only the autopsy itself must include the gross macroscopic
inspection of the lungs; the requirement does not extend to opinions
prepared by reviewing physicians. Finally, the Department rejected the
recommendation of some commenters to adopt the standards for diagnosing
pneumoconiosis by autopsy or biopsy set forth in Kleinerman et al.,
``Pathologic Criteria for Assessing Coal Workers'' Pneumoconiosis,'' in
the Archives of Pathology and Laboratory Medicine (1979). The
Department emphasized its historic reluctance to adopt specific
standards for such diagnoses; the lack of evidence in the record that
the medical community agrees on a particular standard; and the lack of
evidence indicating the Kleinerman article reflects an accepted
standard.
(b)(i) One comment again recommends adopting the criteria for
diagnosing pneumoconiosis by autopsy or biopsy contained in the
Kleinerman article as the ``accepted'' pathologic standard. The
Department has previously noted that the record does not substantiate
the existence of a consensus among physicians for making diagnoses
using these criteria, or the acceptance of the Kleinerman article as
representative of the medical community's views. 64 FR 54978 (Oct. 8,
1999). Indeed, two other commenters commend the Department for refusing
to accept these criteria, noting that other pathologists do not agree
that this article represents a universal or prevailing standard. One
commenter suggests, for example, that Dr. Kleinerman's view that a two-
centimeter lesion on autopsy or biopsy is necessary for a diagnosis of
complicated pneumoconiosis is not universally accepted, and that other
pathologists would require only a one-centimeter lesion. The commenter
urging adoption of the Kleinerman criteria does not supply any
additional information in support of its recommendation. The Department
therefore has no basis in the record for adopting the suggested
standard. (ii) One comment cites Double B Mining, Inc. v. Blankenship,
177 F.3d 240 (4th Cir. 1999), as legal authority for rejecting the
Kleinerman article. In that case, the Court considered whether a biopsy
diagnosis of a certain-sized fibrotic nodule amounted to a ``massive
lesion'' for purposes of proving the miner had complicated
pneumoconiosis under 30 U.S.C. 921(c)(3) (irrebuttable presumption of
total disability due to pneumoconiosis invoked by proof of complicated
pneumoconiosis). The Court cited, among other sources, the Kleinerman
article as requiring a minimum two-centimeter nodule to constitute a
``massive lesion.'' The Court declined to adopt the two-centimeter rule
because ``[t]he [Black Lung Benefits Act] does not mandate use of the
medical definition of complicated pneumoconiosis.'' 177 F.3d at 244.
Instead, the Court held the adjudicator must determine whether a
particular nodule discovered by biopsy would be equivalent to a one-
centimeter opacity if diagnosed by x-ray. The Blankenship decision
rejects only the mandatory use of the medical community's standards for
diagnosing complicated pneumoconiosis by biopsy in view of the court's
statutory analysis. The Court does not accept or reject any specific
clinical criteria for biopsy diagnoses, and the Department does not
interpret the decision as repudiating the Kleinerman article in
particular.
(c)(i) Three comments approve of the restored paragraph (c). (ii)
Two comments approve of the Department's clarification in the second
notice of proposed rulemaking that the Sec. 718.106(a) requirement for
a gross macroscopic inspection of the lungs applies only to the autopsy
itself and not to a reviewing physician's opinion. 64 FR 54978 (Oct. 8,
1999).
(d) No other comments were received concerning this section, and no
other changes have been made in it.
20 CFR 718.107
(a) In the initial notice of proposed rulemaking, the Department
proposed a clarification of Sec. 718.107 which addresses medical
evidence not otherwise covered by the quality standards. 62 FR 3343
(Jan. 22, 1997). Proposed subsection (b) required the party submitting
such evidence to establish that the evidence is medically acceptable
and relevant to proving the existence or nonexistence of
pneumoconiosis, the sequelae of pneumoconiosis or a ``respiratory
impairment.'' The Department responded to comments received from the
public in the second notice of proposed rulemaking. 64 FR 54978 (Oct.
8, 1999). The Department changed the reference in subsection (a) from
``respiratory impairment'' to ``respiratory or pulmonary impairment.''
The Department rejected as unnecessary a recommendation that disability
and disability causation should be added to the relevant issues because
the regulation adequately stated the purposes for which ``other medical
evidence'' could be submitted. One comment approved of Sec. 718.107 as
proposed in the initial notice of proposed rulemaking.
(b) For purposes of the final rule, the Department emphasizes that
Sec. 718.107 as a whole is intended to permit any party to offer any
medical test or procedure which may be relevant to any disputed medical
issue relating to a claimant's entitlement to benefits provided the
requirements of subsection (b) are met.
(c) No other comments were received concerning this section, and no
other changes have been made in it.
[[Page 79937]]
Subpart C
20 CFR 718.201
(a) In the initial notice of proposed rulemaking, the Department
proposed amending Sec. 718.201. 62 FR 3343-44, 3376 (Jan. 22, 1997).
The amendments were designed to clarify the regulatory definition and
conform it to the statute, which broadly defines pneumoconiosis as ``a
chronic dust disease of the lung and its sequelae, including
respiratory and pulmonary impairments, arising out of coal mine
employment.'' 30 U.S.C. 902(b). To that end, the Department proposed
three revisions.
First, the Department inserted the terms ``clinical'' and ``legal''
pneumoconiosis into the regulation to conform it to the terminology
uniformly adopted by the courts to distinguish between the two forms of
lung disease compensable under the statute: pneumoconiosis, as that
disease is defined by the medical community, and any chronic lung
disease arising out of coal mine employment. Second, the Department
proposed revising the definition to make clear that both restrictive
and obstructive lung disease may fall within the definition of
pneumoconiosis if shown to have arisen from coal mine employment.
Third, the Department proposed a revision to recognize the latent and
progressive nature of the disease. The last two changes, for which the
Department cited scientific evidence in support, 62 FR 3343-44 (Jan.
22, 1997), were proposed as a result of recent litigation on these
issues. The Department specifically sought comments on these revisions.
The Department received numerous favorable and unfavorable comments
and testimony on the proposals. 64 FR 54978-79 (Oct. 8, 1999). One
commenter objected to the revised definition because it would include
all obstructive pulmonary diseases. A number of commenters complained
that the Department lacked the statutory authority to implement the
proposals, and that the Department had violated the statute by failing
to consult with the National Institute for Occupational Safety and
Health (NIOSH) before proposing the changes. 30 U.S.C. 902(f)(1)(D).
Several commenters also argued that the Department's proposed
definition was scientifically unsound, and presented testimony from a
panel of pulmonary physicians at the Department's July 22, 1997 hearing
in Washington, D.C., to substantiate their views. Two commenters
contended that because Congress had rejected an amendment to the
statutory definition of pneumoconiosis which would have included
obstructive lung disorders, the Department could not accomplish the
same change through regulation. The Department also received numerous
comments in support of the revised definition. Among the favorable
comments was one from NIOSH, transmitted by letter dated August 20,
1997 and signed by Dr. Paul A. Schulte, Director of NIOSH's Education
and Information Division. Rulemaking Record, Exhibit 5-173. NIOSH
supported the Department's proposal to amend the definition to include
chronic obstructive pulmonary disease and to reflect the scientific
evidence that pneumoconiosis is a progressive condition that may become
detectable only after cessation of coal mine employment in some cases.
The Department also received favorable comments and testimony from
physicians with expertise in pulmonary diseases.
Given the widely divergent comments and testimony received from
medical professionals on the proposed regulation, the Department sought
additional guidance from NIOSH, notwithstanding the fact that NIOSH had
already commented in support of the initial proposal. The Department
transmitted a copy of all of the testimony and commentary it had
received to Dr. Linda Rosenstock, the Director of NIOSH, and asked
NIOSH to determine, in light of the then existing record, whether NIOSH
continued to support the Department's proposal. Rulemaking Record,
Exhibit 66. NIOSH responded, in a December 7, 1998 letter from Dr.
Schulte, that ``[t]he unfavorable comments received by DOL do not alter
our previous position: NIOSH scientific analysis supports the proposed
definitional changes.'' Dr. Schulte provided additional medical
references to support NIOSH's conclusion. Rulemaking Record, Exhibit
72.
The Department responded to the comments it had received in its
second notice of proposed rulemaking. 64 FR 54978-79 (Oct. 8, 1999).
The Department emphasized that the proposed revision was designed to
make clear that obstructive lung disease may fall within the definition
of pneumoconiosis, but only if it is shown to have arisen from coal
mine employment; thus, the proposed definition would not alter the
former regulations' (20 CFR 718.202(a)(4), 718.203 (1999)) requirement
that each miner bear the burden of proving that his lung disease arose
out of his coal mine employment. The Department also notified the
public of NIOSH's December 7, 1998 response, including the additional
evidence NIOSH cited. 64 FR 54978-79 (Oct. 8, 1999). Recognizing that
Congress created NIOSH as a source of expertise in occupational disease
and the analysis of occupational disease research, the Department
concluded it saw no scientific or legal basis upon which to alter its
proposed change to the definition of pneumoconiosis. The Department
further stated its disagreement that Congressional inaction invalidated
its proposed revision of the definition since it was acting within the
scope of Congress' grant of regulatory authority. Accordingly, the
Department proposed no additional changes to this regulation in the
second notice of proposed rulemaking. 64 FR 55012-13 (Oct. 8, 1999).
The Department has now amended subsection (a)(1) by deleting a comma
for grammatical reasons.
(b) The Department has again received both favorable and
unfavorable comments on its proposed revision to the definition of
pneumoconiosis. To the extent these comments are directed specifically
to the Department's proposal to define pneumoconiosis as a latent and
progressive disease, the Department's response is set forth in the
preamble under Sec. 725.309. The Department responds here to the
remainder of the relevant comments, including those addressing the
Department's proposal to include obstructive lung diseases arising out
of coal mine employment within the definition of pneumoconiosis. Where
a scientific article or treatise is cited, the Department has also
cited to a Rulemaking Record Exhibit or, when appropriate, the Federal
Register, where that source appears. This second citation is not an
exhaustive list; thus, each source may appear at additional points in
the Rulemaking Record.
(c) One comment objects to the Department's inclusion of the term
``legal pneumoconiosis'' in the revised definition because there is no
such ``phenomenon.'' Another comment expresses the concern that the
revised regulation would create a new medical diagnosis. The statute
defines pneumoconiosis as ``a chronic dust disease of the lung and its
sequelae, including respiratory and pulmonary impairments, arising out
of coal mine employment.'' 30 U.S.C. 902(b). This broad definition
encompasses not only coal workers' pneumoconiosis as that disease is
contemplated by the medical community, but also any other chronic lung
disease demonstrably related to coal mine employment but not typically
denominated as pneumoconiosis in medical circles. Thus, the Department
is making a legal distinction, rather than a medical one, by employing
the phrase ``legal pneumoconiosis'' in order to
[[Page 79938]]
properly implement Congress' intent. In so doing, the Department is
acknowledging the distinction already adopted by the circuit courts of
appeals in construing and applying the statutory definition. See, e.g.,
Gulf & Western Industries v. Ling, 176 F.3d 226, 231-32 (4th Cir.
1999); Bradberry v. Director, OWCP, 117 F.3d 1361, 1368 (11th Cir.
1997); Labelle Processing Co. v. Swarrow, 72 F.3d 308, 315 (3d Cir.
1995); Consolidation Coal Co. v. Hage, 908 F.2d 393, 395-396 (8th Cir.
1990); Campbell v. Consolidation Coal Co., 811 F.2d 302, 304 (6th Cir.
1987); Peabody Coal Co. v. Lowis, 708 F.2d 266, 268 n.4 (7th Cir.
1983).
(d) Several comments express concern over including obstructive
pulmonary diseases in the definition of pneumoconiosis, believing such
change will result in compensating miners for diseases caused by
factors unrelated to coal mine employment. Whether coal mine dust
exposure can cause chronic obstructive pulmonary disease is a question
of medical and scientific fact that will not vary from case to case;
thus, it is an appropriate question for the Department to answer by
regulation. See generally Peabody Coal Co. v. Spese, 117 F.3d 1001,
1010 (7th Cir. 1997) (en banc); Davis, Administrative Law Treatise,
Sec. 6.7, 261-262 (3d ed. 1994). The revised definition will eliminate
the need for litigation of this issue on a claim-by-claim basis, and
render invalid as inconsistent with the regulations medical opinions
which categorically exclude obstructive lung disorders from
occupationally-related pathologies. The Department reiterates, however,
that the revised definition does not alter the former regulations' (20
CFR 718.202(a)(4), 718.203 (1999)) requirement that each miner bear the
burden of proving that his obstructive lung disease did in fact arise
out of his coal mine employment, and not from another source. Thus,
instead of attempting to force the conclusion, as one commenter
contends, that all obstructive lung disorders are compensable, or to
require responsible operators to compensate miners for non-
occupationally related diseases, the language of the proposed
regulation makes plain that only ``obstructive pulmonary disease
arising out of coal mine employment'' falls within the definition of
pneumoconiosis.
(e) Several comments criticize the Department's consultation with
NIOSH. Calling the Department's solicitation of an opinion from NIOSH
on the relevant medical questions a ``post-hoc attempt to rationalize
the validity of its medical conclusions'' and a ``purely political
act,'' one commenter states that Dr. Shulte's letter cannot substitute
for ``genuine scientific review.'' Other commenters allege that NIOSH
presented no serious medical or scientific analysis to support its
position. To the extent these comments accuse the Department of
obtaining assistance from NIOSH's information officer rather than its
scientific staff, the Department's response is set forth in the
preamble under Sec. 725.309. NIOSH voluntarily submitted its first
statement in support of the proposed revision to the definition of
pneumoconiosis during the public comment period for the initial
rulemaking proceeding. The Department then actively solicited an
additional opinion from NIOSH in response to other comments the
Department had received requesting such consultation and not, as the
commenter suggests, to provide ``post-hoc'' rationalization for the
proposed revisions to the regulation. NIOSH responded, and the
Department set forth the substance of the response in the second notice
of proposed rulemaking. 64 FR 54978-79. In response to the second
notice, NIOSH once again submitted an unsolicited comment during the
public comment period reaffirming its earlier statements that it had
reviewed the proposed rule and supported it. Thus, NIOSH has supported
the Department's proposal from the outset. Further, in each of its
communications, NIOSH repeatedly provided concrete support for its
comments by referencing appropriate studies and its own publication,
National Institute for Occupational Safety and Health, Criteria for a
Recommended Standard, Occupational Exposure to Respirable Coal Mine
Dust (1995). 62 FR 3343 (Jan. 22, 1997); Rulemaking Record, Exhibit 2-
1. This publication provides the most exhaustive review and analysis of
the relevant scientific and medical evidence through 1995, including
its evaluation of the evidence regarding the role smoking plays in a
coal miner's respiratory status. The conclusions NIOSH reached there as
a result of its analysis fully support the position it has taken in
commenting during these rulemaking proceedings. Accordingly, the
Department rejects these broad-based attacks on NIOSH's conclusions as
a basis for altering this regulation.
(f) Various comments state, without specificity, that the
Department's proposed revisions to the definition of pneumoconiosis
lack valid scientific or medical support. Other comments attack the
scientific basis of the conclusions that the Department and NIOSH have
drawn from the evidence of record. In support, these commenters have
submitted an analysis of some of the available medical literature from
Dr. Gregory Fino, a Board-certified physician in Pulmonary Diseases,
and Dr. Barbara Bahl, who has a doctorate in nursing and biostatistics.
Their review of the literature regarding obstructive lung disease and
pulmonary dysfunction in coal miners led them to conclude that
virtually all of the articles they reviewed are flawed, and that there
is no evidence of a clinically significant reduction in lung function
resulting from coal mine dust exposure. (Rulemaking Record, Exhibit 89-
37, Appendix C). They elaborate:
There are a number of statements that can and cannot be said
about obstruction in coal miners. Some of the articles discussed in
Table 1 above do demonstrate a reduction in the FEV1 in highly
selected cohorts of miners. Because of selection bias, the results
cannot be applied to all miners in general. Since the reductions in
the FEV1 are averages, it is statistically impossible to state
whether a given miner would have FEV1 reductions greater than or
less than the stated amount. The articles do not say and do not show
that coal mine dust inhalation causes a clinically significant
reduction in the FEV1. Just because a statistically significant
reduction was encountered in the selected cohorts, there is no
evidence at all that the reductions would participate in any
respiratory impairment or disability.
While there is no doubt that some miners do have clinically
significant obstruction as a result of coal mine dust inhalation, it
occurs in cases of severe fibrosis where a combined obstructive and
restrictive defect is present. However, there is no evidence that
there is a clinically significant reduction in the FEV1 as a result
of chronic obstructive lung disease due to coal mine dust
inhalation. None of the studies show that. None of the studies can
be generalized to the average coal miner. Moreover, statistical
significance neither implies nor infers clinical significance. As
the above studies demonstrate, statistical significance has created
many numbers that are not applicable to the evaluation of coal
miners. The conclusions reached by Morgan (1, 24, 35) and published
over two decades [ago] still hold true: coal mine dust may cause
slight, clinically insignificant decreases in the FEV1 in some
miners. There is no evidence that these decreases cause or
contribute to pulmonary disability and no support for the assumption
in the Department's regulation that coal dust causes or contributed
to any miner's obstructive lung disease.
Rulemaking Record, Exhibit 89-37, Appendix C at 24-25. In a
separate review of literature relating to emphysema in particular, Drs.
Fino and Bahl conclude that ``[t]he amount of emphysema in the lungs of
miners increases with the severity of simple coal workers'
pneumoconiosis.'' This increase in severity as shown by chest
[[Page 79939]]
X-ray or autopsy ``is not correlated with a worsening of lung
function,'' and the relevant studies ``have not shown clinically
significant deterioration in lung function as the emphysema worsens.''
Rulemaking Record, Exhibit 89-37, Appendix C at 32-33.
The Department has reviewed all of the medical and scientific
evidence referenced in the rulemaking record, and does not agree that
the record lacks valid support for the proposition that coal mine dust
exposure can cause obstructive pulmonary disease. The Department's
position is fully supported by NIOSH, the statutory advisor to the
black lung benefits program, which responded favorably to the
Department's proposed revisions. Rulemaking Record, Exhibits 5-173, 72,
89-26. The considerable body of literature documenting coal mine dust
exposure's causal effect on the development of chronic bronchitis,
emphysema and associated airways obstruction constitutes a clear and
substantial basis for this aspect of the revised definition of
pneumoconiosis.
The term ``chronic obstructive pulmonary disease'' (COPD) includes
three disease processes characterized by airway dysfunction: chronic
bronchitis, emphysema and asthma. Airflow limitation and shortness of
breath are features of COPD, and lung function testing is used to
establish its presence. Clinical studies, pathological findings, and
scientific evidence regarding the cellular mechanisms of lung injury
link, in a substantial way, coal mine dust exposure to pulmonary
impairment and chronic obstructive lung disease. In discharging its
congressionally-mandated duty to recommend a permissible exposure limit
for coal mine dust, NIOSH conducted a comprehensive review of the
available medical and scientific evidence addressing the impact of coal
mine dust exposure on coal miners. It published its findings in
National Institute for Occupational Safety and Health, Criteria for a
Recommended Standard, Occupational Exposure to Respirable Coal Mine
Dust (1995) (Criteria). 62 FR 3343 (Jan. 22, 1997); Rulemaking Record,
Exhibit 2-1. NIOSH concluded that ``[i]n addition to the risk of simple
CWP and PMF [progressive massive fibrosis], epidemiological studies
have shown that coal miners have an increased risk of developing
COPD.'' Criteria 4.2.3.2, Rulemaking Record, Exhibit 2-1 at 57.
Drs. Fino and Bahl disagree, but the Department believes that their
opinions are not in accord with the prevailing view of the medical
community or the substantial weight of the medical and scientific
literature. For example, Seaton, in ``Coal Workers' Pneumoconiosis,''
in Morgan WKC, Seaton A, eds., Occupational Lung Diseases (WB Saunders
Co., 3d ed. 1995) 374-406, see also Rulemaking Record, Exhibit 89-37,
Appendix C at 34, 42, reviewed much of the same published evidence and
made the following analysis:
Lung function, measured as the forced expiratory volume in 1
second (FEV1) has been shown both in cross-sectional and
longitudinal studies to decline in relation to increasing
underground dust exposure but not in relation to estimates of
exposure to oxides of nitrogen. This decline occurs at a similar
rate in smokers and nonsmokers, although the loss of lung function
overall is greater in smokers, the two effects being additive.
Similarly, Becklake, in ``Pneumoconiosis,'' in Murray J, Nadel J,
eds., Textbook of Pulmonary Medicine (1st ed. 1988) 1556-1592, see also
Criteria, Rulemaking Record, Exhibit 2-1 at 204, concludes:
Most evidence to date indicates that exposure to coal mine dust
can cause chronic airflow limitation in life and emphysema at
autopsy, and this may occur independently of CWP * * * The
relationships between hypersecretion of mucus (chronic bronchitis)
and chronic airflow limitation (emphysema) on the one hand and
environmental factor of coal mining exposure on the other appear to
be similar to those found for cigarette smoking.
Oxman and colleagues analyzed the available literature assessing
the relationship between occupational dust exposures and COPD in 1993.
Oxman AD, Muir DCF, Shannon HS, Stock SR, Hnizdo E, Lange HJ,
``Occupational dust exposure and chronic obstructive pulmonary disease:
A systematic overview of the evidence,'' Am Rev Resp Dis, 148:38-48
(1993); see also Rulemaking Record, Exhibit 5-174, Appendix 8. Reports
were analyzed for methodological criteria including dust exposure,
control for smoking, exclusion of confounding pulmonary conditions,
referral bias, and adequate follow-up. Thirteen reports that met their
rigorous screening criteria were analyzed. They concluded that all of
the studies found a statistically significant association between
cumulative dust exposure and decline in lung function, and that coal
mine dust can be a cause of chronic bronchitis. Unlike Drs. Fino and
Bahl, the Oxman analysis concluded there was also a clinically
significant loss of lung function in smokers and nonsmokers.
Drs. Fino and Bahl state that all of the studies identifying a
decline in lung function ``are flawed because of selection bias. The
results are not generalizable to the general population of miners.''
Rulemaking Record, Exhibit 89-37, Appendix C at 21. As recognized by
many of the authors of these studies, the results are susceptible to a
selection bias caused by miners leaving the industry between the time
of initial pulmonary function measurement and those taken later during
the follow-up period. Because of the ``healthy worker effect,'' it
would be expected that workers more prone to the respiratory
impairments caused by coal mine dust inhalation would leave mining and
the healthier workers would continue working. Oxman concluded that
``[a]lthough it is impossible to estimate precisely the magnitude of
this bias,'' its direction ``is towards underestimating the association
between dust and loss of lung function, or failure to recognize a more
susceptible subgroup of workers.'' Oxman at 46. Thus, this selection
bias actually underestimates the association between inhalation of coal
mine dust and loss of lung function. As Oxman explains, ``it is likely
that the results underestimate the effect of occupational dust exposure
on lung function, COPD, and chronic bronchitis. The magnitude of the
bias is not clear, but it might, in some cases, result in estimates
that are 50% or more of the true coefficients.'' Oxman at 47. Moreover,
as Coggon and Newman Taylor remarked in the course of surveying the
relevant medical literature, such selection effects are relatively
unimportant because ``[t]here is no obvious reason why the relation of
symptoms and lung function to dust should have been weaker in those
omitted from investigation.'' Coggon D, Newman Taylor A, ``Coal mining
and chronic obstructive pulmonary disease: a review of the evidence,''
Thorax 53:398-407, 400 (1998); see also 64 FR 54979 (Oct. 8, 1999)
Simply stated, there is a clear relationship between coal mine dust and
COPD and lung dysfunction, and that relationship is likely to be
stronger than what we are able to measure.
Drs. Fino and Bahl conclude that any minimal obstruction resulting
from coal mine dust exposure is not clinically significant. Marine's
cross-sectional 1988 study of coal miners, however, found clinically
significant decreases in pulmonary function in both smokers and
nonsmokers. Marine WM, Gurr D, Jacobsen M, ``Clinically important
respiratory effects of dust exposure and smoking in British coal
miners,'' Am Rev Resp Dis, 137:106-112 (1988); see also Criteria,
Sec. 4.2.2.1, Rulemaking Record, Exhibit 2-1 at 52. This study also
noted that the presence of chronic
[[Page 79940]]
bronchitis was clearly related to cumulative dust exposure. The table
below summarizes the study's data:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cumulative dust exposure (in percent)
---------------------------------------------------------------------------------------------------------------------------------------------------------
Zero exposure Intermediate exposure (174 ghm High exposure (348 ghm -3)
-------------------------------- -3) -------------------------------
Measure of respiratory dysfunction --------------------------------
Smoker Nonsmoker Smoker Nonsmoker Smoker Nonsmoker
--------------------------------------------------------------------------------------------------------------------------------------------------------
FEV1 80%................................................ 17.1 9.7 24.2 15.5 40.0 23.9
Chronic bronchitis...................................... 30.5 7.9 41.2 14.8 52.8 26.3
Chronic bronchitis+FEV1 80%............................. 7.6 1.5 14.9 3.9 27.3 9.8
FEV1 65%................................................ 5.0 3.2 8.5 5.0 14.2 7.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note to table: Percentages are estimates of prevalence of measures of respiratory dysfunction based on linear logistic models at an age of 47 years at
varying amounts of cumulative dust exposure.
As can be seen from this table, the incidence of nonsmoking coal
miners with intermediate dust exposure developing moderate obstruction
(FEV1 of less than 80%) is roughly equal to the incidence of moderate
obstruction in smokers with no mining exposure (15.5% v. 17.1%).
Similarly, the incidence of non-smoking miners with intermediate
exposure developing severe airways obstruction (FEV1 of less than 65%)
is equal to the incidence of severe obstruction in non-mining smokers
(5.0% for both groups). Nonsmokers with high exposure are at greater
risk for developing moderate or severe obstruction than unexposed
smokers. Smokers who mine have additive risk for developing significant
obstruction. The risk of chronic bronchitis clearly increases with
increasing dust exposure; again smokers who mine have an additive risk
of developing chronic bronchitis. The message from the Marine study is
unequivocal: Even in the absence of smoking, coal mine dust exposure is
clearly associated with clinically significant airways obstruction and
chronic bronchitis. The risk is additive with cigarette smoking.
Drs. Fino and Bahl criticize the Marine study because it used the
mean of each miner's three FEV1 values rather than the highest.
Rulemaking Record, Exhibit 89-37, Appendix C at 17, 21. This, however,
does not appear to be a significant problem given that a number of
other studies which used the highest FEV1 value for analysis also
showed the same adverse relationship between coal dust inhalation and
pulmonary impairment. One such study was reported by Attfield and
Hodous in 1992. Attfield MD, Hodous TK, ``Pulmonary function of U.S.
coal miners related to dust exposure estimates,'' Am Rev Respir Dis
145:605-609 (1992); see also Criteria, Sec. 4.2.2, Rulemaking Record,
Exhibit 2-1 at 51. Attfield and Hodous analyzed pulmonary function data
(specifically, FEV1, FVC and FEV1/FVC ratio) drawn from Round 1 of the
National Study of Coal Workers' Pneumoconiosis, along with job-specific
cumulative dust exposure estimates for U.S. underground coal miners, to
determine whether there was an exposure-response relationship. This
group of 7,139 miners worked both before and after 1970, when
federally-mandated dust control standards were implemented. Allowing
for decrements due to age and smoking history, Attfield and Hodous
demonstrated a clear relationship between dust exposure and a decline
in pulmonary function of about 5 to 9 milliliters a year, even in
miners with no radiographic evidence of clinical coal workers'
pneumoconiosis. These results were similar to those reached in studies
of British coal miners.
Drs. Fino and Bahl (Rulemaking Record, Exhibit 89-37, Appendix C at
22), as well as other commenters, criticize this study and similar ones
that are based on exposures prior to 1970, when federally-mandated dust
control standards were implemented, on the grounds of selection bias.
Their theory is that only those miners who worked in a dust-controlled
environment are representative of the current adverse effects of coal
mine dust exposure. This theory is flawed. While lower dust exposure
should reduce both the occurrence and the severity of lung disease, the
kinds of diseases will remain the same. Indeed, Attfield and Hodous
specifically chose to use data from miners with presumably higher dust
exposures so as to facilitate the detection of exposure-response
relationships. Attfield and Hodous, Am Rev Respir Dis 145:605.
In any event, analysis of data from miners who worked only in dust-
controlled conditions confirm the connection between coal mine dust
exposure and obstructive lung disease. Seixas and colleagues considered
a group of 1,185 miners who began working in 1970 or later. Seixas NS,
Robins TG, Attfield MD, Moulton LH, ``Exposure-response relationships
for coal mine dust and obstructive lung disease following enactment of
the Federal Coal Mine Health and Safety Act of 1969,'' Am J Ind Med
21:715-732 (1992); see also Criteria, Sec. 4.2.2.3.1, Rulemaking
Record, Exhibit 2-1 at 54. The data they reviewed was collected during
Round 4 of the National Study of Coal Workers' Pneumoconiosis, and
included chest X-rays, ventilatory function tests (including FEV1, FVC
and FEV1/FVC ratio), and relevant histories for each miner. The results
of this cross-sectional analysis, when adjusted for age, race/ethnicity
and smoking, demonstrated a declination in pulmonary function
attributable to coal mine dust-induced obstructive lung disease.
Longitudinal studies have confirmed these results. See generally
Criteria, Sec. 4.2.2.3.1.2, Rulemaking Record, Exhibit 2-1 at 55. One
noteworthy study is Attfield MD, ``Longitudinal decline in FEV1 in
United States coalminers,'' Thorax 40:132-137 (1985); see also
Criteria, Sec. 4.2.2.3.1.2, Rulemaking Record, Exhibit 2-1 at 55. Using
medical data from two National Coal Study surveys held nine years
apart, Attfield evaluated the effects of dust exposure on a group of
1,072 miners aged 20-49 years. The data included chest X-rays, smoking
and work histories, and spirometry, as well as dust exposure estimates.
After accounting for age, height and smoking, Attfield found a coal
mine dust-related FEV1 loss of 36 to 84 ml over 11 years, with an
additional loss among smokers. Attfield's results confirmed similar
studies analyzing data from miners in the U.K. See, e.g., Love RG,
Miller BG, ``Longitudinal study of lung function in coal-miners,''
Thorax 37:193-197 (1982); see also Criteria, Sec. 4.2.2.3.1.2,
Rulemaking Record, Exhibit 2-1 at 55.
Drs. Fino and Bahl contend, however, that the average decline shown
in these studies, while perhaps statistically
[[Page 79941]]
relevant, is not clinically relevant and does not result in any
impairment. Attfield and Hodous responded succinctly to such criticism,
equating pulmonary function decrements in miners to the decline of lung
function in non-mining smokers from the general population: ``If it is
thought that a 5- to 9-ml decrement of FEV1 per year is clinically
insignificant, it must be remembered that the average decrement for
smokers was only 5 ml per pack year. This, in itself, is also a minor
loss of lung function. However it is well known that smoking can cause
severe effects in some smokers.'' Attfield and Hodous, Am Rev Respir
Dis 145:608. Just as not all smokers develop COPD and pulmonary
dysfunction, pulmonary impairment is not universal in coal miners. Drs.
Fino and Bahl state that ``an average loss of FEV1 means that 50% of
the miners will have losses in excess of the average and 50% will have
losses smaller than the average.'' Rulemaking Record, Exhibit 89-37,
Appendix C at 21. This conclusion does not stand up to scrutiny because
it confuses the average with the median. As can be seen from Marine's
table above, only a minority of miners will have significant decrements
in pulmonary function. As the majority of miners may have small or,
perhaps in some cases, no decline in pulmonary function, the average
decline of the population studied can appear to be relatively small.
Despite this, the individual miners affected can have quite severe
disease, and statistical averaging hides this effect. The amended
definition clarifies that these miners have a right to prove their case
with evidence of a disabling obstructive lung disease that arose out of
coal mine employment.
Pointing to Coggon and Newman Taylor's statement that ``some
scientists have expressed doubts as to whether coal mine dust can cause
clinically important loss of lung function,'' Coggon D, Newman Taylor
A, ``Coal mining and chronic obstructive pulmonary disease: A review of
the evidence,'' Thorax 53:398-407 (1998); see also 64 FR 54979 (Oct. 8.
1999); Rulemaking Record, Exhibit 89-37, Appendix C at 24, Drs. Fino
and Bahl state that the studies have not shown this type of loss of
pulmonary function. Rulemaking Record, Exhibit 89-37, Appendix C at 24.
The implication that Coggon and colleague agree with this conclusion is
misleading. The paragraph containing the quoted sentence notes that
there is evidence connecting COPD with coal mining and that ``in view
of this continuing controversy, it is helpful to review the evidence as
it now stands.'' The authors reviewed data from the National Study of
Coal Workers' Pneumoconiosis, the Pneumoconiosis Field Research
Programme (U.K.), studies from Sardinia and Germany, and mortality and
necropsy studies. They concluded:
Reductions in lung function have been found in relation to coal
mining with remarkable consistency. * * * Individually, all of the
studies that have addressed the relation of coal mining to lung
function have limitations, but these vary from one investigation to
another and often would tend to obscure rather than exaggerate any
effect of dust. The balance of evidence points overwhelmingly to
impairment of lung function from coal mine dust exposure.
Coggon, Thorax 53:405. Coggon and Newman Taylor further concluded
that: Coal mine dust inhalation can be disabling, and arguments against
this thesis are ``unconvincing'; and ``the combined effects of coal
mine dust and smoking on FEV1 appear to be additive.'' Coggon, Thorax
53:405-406. Thus, this study supports the Department's position.
Similarly, several of the medical treatises and studies cited by
another commenter in support of its contention that there is no such
causal link between coal mine dust exposure and obstructive lung
disease do not negate (and, in fact, support) the conclusion the
Department and NIOSH have reached. See, e.g., Morgan WKC,
``Pneumoconiosis,'' in Brewis RAL, Corrin B, Geddes DM, Gibson GJ,
eds., Respiratory Medicine (WB Saunders Co., 2d ed. 1995) 581; see also
Rulemaking Record, Exhibit 89-21, attachment 1 (``it is clear that
bronchitis induced by coal-mine dust, henceforth referred to as
industrial bronchitis, leads to a reduction in ventilatory capacity'');
Green FHY, Vallyathan V, ``Coal Workers'' Pneumoconiosis and
Pneumoconiosis Due to Other Carbonaceous Dusts,'' in Chung A, Green
FHY, eds., Pathology of Occupational Lung Disease (2d ed. 1998) 189;
see also Rulemaking Record, Exhibit 89-21, attachment 2 (coal dust
exposure is ``associated with significant deficits in lung function in
the absence of [clinical] CWP, reinforcing the view that COPD and CWP
have independent risk factors''); ``Occupational Lung Disease,'' in
Hasleton PS, ed., Spencer's Pathology of the Lung (5th ed. 1996) 482;
see also Rulemaking Record, Exhibit 89-21, attachment 4 (``A
considerable body of evidence indicates that chronic bronchitis and
emphysema in coal workers is directly related to tobacco usage and
cumulative exposure to respirable dust during life.''); Roy TM et al.,
``Cigarette Smoking and Federal Black Lung Benefits in Bituminous Coal
Miners,'' J Occ Med 31(2):100 (1989); see also Rulemaking Record,
Exhibit 89-21, attachment 5 (``Well-designed investigations have now
documented that coal dust exposure can cause reductions in FEV1 that
are independent of age and cigarette smoking. * * * it appears that the
major damage caused by cigarette smoking is additive to the minor
damage which can be attributed to coal dust.''); Surgeon General, U.S.
Department of Health and Human Services, ``Respiratory Disease in Coal
Miners,'' The Health Consequences of Smoking: Cancer and Chronic Lung
disease in the Workplace, 313 (1985); see also Rulemaking Record,
Exhibit 89-21, attachment 11 (concluding that ``increasing coal dust
exposure is associated with increasing airflow obstruction in both
smokers and nonsmokers''). To the extent this commenter advocates that
tobacco smoking, rather than coal mine dust exposure, causes the only
significant obstructive disorders miners develop, and that the
definition of pneumoconiosis ``must be tightened to deal with the truth
of tobacco's role in causing what has been compensated as black lung,''
the Department reiterates that the studies cited above, as well as
others, found a significant decrement in coal miners' pulmonary
function in addition to that caused by smoking. Whether a particular
miner's disability is due to his coal mine employment or smoking habit
must be resolved on a claim-by-claim basis under the criteria set forth
at Sec. 718.204.
Drs. Fino and Bahl find no scientific support that clinically
significant emphysema exists in coal miners without progressive massive
fibrosis, Rulemaking Record, Exhibit 89-37, Appendix C at 31, but the
available pathologic evidence is to the contrary. Cockcroft evaluated
39 coal workers and 48 non-coal worker controls dying of cardiac causes
in 1979. Cockcroft A, Wagner JC, Ryder R, Seal RME, Lyons JP, Andersson
N, ``Post-mortem study of emphysema in coalworkers and non-
coalworkers,'' Lancet 2:600-603 (1982); see also Criteria,
Sec. 4.2.2.2, Rulemaking Record, Exhibit 2-1 at 52. Centrilobular
emphysema (the predominant type observed) was significantly more common
among the coal workers. The severity of the emphysema was related to
the amount of dust in the lungs. These findings held even after
controlling for age and smoking habits.
Similarly, Leigh and colleagues analyzed 886 miners who died
between 1949 and 1982. Leigh J, Outhred KG, McKenzie HI, Glick M, Wiles
AN,
[[Page 79942]]
``Quantified pathology of emphysema, pneumoconiosis and chronic
bronchitis in coal workers,'' BR J Indust Med 40:258-263 (1983); see
also Criteria, Sec. 4.2.2.2, Rulemaking Record, Exhibit 2-1 at 53. They
found that miners with more years of face work had worse emphysema
pathologically. In a subsequent study of 264 underground coal miners
exposed to mixed coal and silica dust, Leigh performed a multiple
regression analysis to assess the effects of total lung coal content,
total lung silica content, smoking history, and years at the coal face
on pulmonary function, extent of emphysema, and extent of fibrosis.
Leigh J, Driscoll TR, Cole BD, Beck RW, Hull BP, Yang J, ``Quantitative
relation between emphysema and lung mineral content in coalworkers,''
Occ Environ Med 51:400-407 (1994); see also Criteria, Sec. 4.2.2.2,
Rulemaking Record, Exhibit 2-1 at 53. Multiple regression analysis is a
powerful statistical tool used to identify which of a series of
variables is responsible for an observed correlation, and to eliminate
apparent correlations that can be explained by other true
relationships. He made the following important findings: (1) The extent
of emphysema was strongly related to the total coal content of the
lung, age and smoking; (2) in miners who were lifelong non-smokers, the
extent of emphysema was strongly related to coal content and age; (3)
the extent of emphysema was unrelated to lung silica content; and (4)
the extent of lung fibrosis was related to silica content. The authors
concluded that ``these results provide strong evidence that emphysema
in coalworkers is causally related to lung coal content.'' Leigh, Occ
Environ Med 51:400.
Ruckley and colleagues achieved similar results in examining the
lungs of 450 coal workers to determine the association between coal
mine dust exposure and dust-related fibrosis and emphysema. Ruckley VA,
Gauld SJ, Chapman JS, et al., ``Emphysema and dust exposure in a group
of coal workers,'' Am Rev Resp Dis 129:528-532 (1984); see also
Criteria, Sec. 4.2.2.2, Rulemaking Record, Exhibit 2-1 at 53. Emphysema
was graded by standard techniques, smoking histories were obtained by
questionnaire and Pneumoconiosis Panel records, and lung dust content
was analyzed pathologically. Relationships between emphysema and
possible explanatory variables were tested by multiple logistic
regression models, which exclude confounding variables in analyzing
causal effects. The authors found emphysematous changes in 72% of
miners who smoked, 65% of ex-smokers, and 42% of nonsmoking miners;
emphysema scores were higher in patients with increasing evidence of
pneumoconiotic disease; and increasing coal lung dust was associated
with the presence of emphysema. Forty-seven percent of miners with no
fibrotic lesions had emphysema. Ruckley concluded that ``the results
support the conclusion that the relationship observed between
respirable dust and emphysema in coal workers is, in some way,
causal.'' Ruckley, Am Rev Resp Dis 129:532.
Drs. Fino and Bahl point to several other sources in support of
their view that clinically significant emphysema is not related to coal
dust exposure in the absence of PMF. They quote Morgan's textbook,
Occupational Lung Diseases, as saying that changes of focal emphysema
cannot be equated with airways obstruction. The commenters fail to note
additional comments in the same textbook:
The increased risk of centriacinar emphysema in PMF cases away
from the lesion, and, in simple pneumoconiosis, in relation to dust
exposure supports the hypothesis that coal dust exposure sufficient
to cause alveolar inflammation and fibrosis also initiates
centriacinar emphysema. This seems a likely explanation for the
consistent epidemiologic finding of decrements in FEV1 and FVC and a
rise in residual volume in relation to the indices of dust exposure
in coal miners.
Seaton, Occupational Lung Diseases at 400-401. Morgan's conclusions are
also somewhat suspect because he has admitted that at least in
commenting on the Cockcroft paper, some of his criticisms were
inaccurate and not valid or fair. Judgement of Mr. Justice Turner, The
British Coal Respiratory Disease Litigation, Jan. 23, 1998, Rulemaking
Record, Exhibit 72. Dr. Fino and Bahl's citation to Snider, Snider GL,
``Emphysema: the first two centuries-and beyond. A historical overview,
with suggestions for future reference,'' Am Rev Resp Dis 146:1333-1344
(Part 1) and 146:1615-1622 (Part 2) (1992); see also Rulemaking Record,
Exhibit 89-37, Appendix C at 34, is also unhelpful because the articles
contain no opinion as to whether emphysema in coal miners can be
clinically significant or affects pulmonary function. Coal dust
exposure was plainly not the focus of these articles.
The Department's proposed revision to the definition of
pneumoconiosis is also supported by the growing evidence of the adverse
affects of coal mine dust exposure at the cellular level leading to
obstructive lung disease. Criteria, 4.3, Rulemaking Record, Exhibit 2-1
at 65-69; see generally Coggon, Thorax 53:404. Alveolar macrophages are
cells that are normally situated in the alveoli, or gas-exchange units
of the lung. Their normal function is to recognize foreign substances,
phagocytize (ingest) these substances, and activate other inflammatory
cells. Coal dust, in turn, causes leakage of destructive protease and
elastase enzymes from alveolar macrophages. These enzymes can destroy
the network of elastin and collagen proteins that comprise the
underlying support structure of the lung architecture; the release of
these enzymes from inflammatory cells is thus associated with the
production of emphysema. Lung lavage studies are performed by washing
an area of lung with saline instilled through a fiberoptic bronchoscope
placed through a subject's throat and wedged into the lung. These
studies of nonsmoking coal miners with simple CWP showed activation of
macrophages with evidence of ingestion of dust particles, a finding not
present in normal controls. Takemura T, Rom WM, Ferrans VJ, Crystal RG,
``Morphologic characterization of alveolar macrophages from subject
with occupational exposure to inorganic particles,'' Am Rev Resp Dis
140:1674-1685 (1989); see also Criteria, Sec. 4.3.3, Rulemaking Record,
Exhibit 2-1 at 69. A subsequent lavage study of nonsmoking coal miners
found that the macrophages spontaneously released substances toxic to
the lung, including reactive oxygen species and elastase. These
substances were released in significantly higher quantities in miners
than in non-mining smokers or in non-mining nonsmokers without lung
disease. Rom WN, ``Basic mechanisms leading to focal emphysema in coal
workers'' pneumoconiosis,'' Environ Res 53:16-28 (1990); see also
Rulemaking Record, Exhibit 5-174, Appendix 8. As noted, the reactive
oxygen species damage cell membranes, cell proteins, and DNA. Over-
secretion of these substances may overwhelm the lung's natural defenses
(such as anti-oxidants and anti-proteases). The unopposed proteases and
elastases can destroy lung tissue, causing emphysema.
Reactive oxygen substances have been shown to damage anti-proteases
in the lung. Anti-proteases are enzymes that protect the lung from
proteases and elastases that are released during an inflammatory
reaction (such as that produced by inhalation of coal mine dust).
Without this protection, the proteases and elastases can destroy the
elastin and collagen that comprise the structure of the lung, resulting
in
[[Page 79943]]
emphysematous changes. This was demonstrated in an animal model of coal
dust inhalation, where the coal dust was found to increase elastase
levels and cause degradation of alpha-1 antitrypsin (one of the
protective enzymes) in association with pathologic findings of
emphysema. In vitro studies have also demonstrated that the protective
anti-protease activity of alpha-1 antitrypsin is decreased by exposure
to coal dust. These observations support the theory that dust-induced
emphysema and smoke-induced emphysema occur through similar
mechanisms--namely, the excess release of destructive enzymes from
dust- (or smoke-) stimulated inflammatory cells in association with a
decrease in protective enzymes in the lung.
Animal and human studies have also shown that coal mine dust
inhalation can recruit neutrophils, another inflammatory cell, into the
lung. Rom WN (1990). Activated neutrophils produce elastase as well as
other inflammatory mediators. The recruitment of neutrophils and the
activation of alveolar macrophages is greater in nonsmoking coal miners
with pulmonary impairment than either non-miners or nonsmoking miners
without pulmonary impairment. This suggests that a combination of coal
mine dust exposure and host susceptibility may be required to produce
disease. Thus, although many of the studies evaluating mechanisms of
pathogenesis of coal mine dust exposure concentrate on the development
of fibrosis, there is considerable basic scientific data linking coal
mine dust to the development of obstructive airways disease.
Moreover, cytokines, which are chemical substances released from a
number of cells in the lung, have been implicated in the development of
lung disease in coal miners. Criteria, Sec. 4.3.1, Rulemaking Record,
Exhibit 2-1 at 65-69. Tumor necrosis factor- (TNF) and
Interleukin 6 (IL-6) are two of them. TNF is released by alveolar
macrophages as well as other cells in response to coal dusts (as well
as other mineral dusts). TNF stimulates lung fibrosis. Patients with
progressive CWP have higher TNF release from lung monocytes. TNF
release is also increased in coal miners with airflow obstruction. TNF
has been demonstrated to be an important mediator in obstructive
airways diseases including COPD and asthma. Alveolar macrophages have
been shown to release IL-6 in response to exposure to coal mine dust.
Increased IL-6 levels were noted in lungs of coal miners with CWP. IL-6
has been implicated in the creation of inflammatory changes of the
lower respiratory tract in chronic bronchitis as well as reactive
airways disease. In addition, other cellular mediators, including
leukotriene B4, thromboxane A2, prostaglandin E2, and platelet
activating factor, have been shown to be produced by alveolar
macrophages or other pulmonary cells in response to coal mine dust and
are well known to play a role in the production of reactive airways
disease. Thus, there is considerable basic scientific data linking coal
dust to the development of obstructive airways disease.
One commenter repeatedly accuses the Department of not supporting
its definitional change with ``peer-reviewed'' scientific and medical
studies, but does not point to any study or article in particular. The
Department rejects this assertion. Each of the articles and studies
cited above, as well as the majority relied upon by NIOSH in the
Criteria document, appeared in a peer-reviewed journal: American Review
of Respiratory Disease, American Journal of Industrial Medicine,
Thorax, Journal of Occupational Medicine, Lancet, British Journal of
Industrial Medicine, Occupational Environmental Medicine, Environmental
Research, and others. The textbooks relied upon are authored and edited
by highly respected professionals in the field. Textbook editors serve
as peer-reviewers of the relevant published literature because they
comprehensively survey, evaluate the validity of, and comment on, the
literature. Seaton's review in Morgan and Seaton's Occupational Lung
Disease is a good example. Moreover, the NIOSH Criteria document,
Rulemaking Record, Exhibit 2-1, received extensive peer review prior to
its publication. See Criteria, Rulemaking Record, Exhibit 2-1 at xxii-
xxiv.
It bears repeating that in developing its recommended dust exposure
standard, NIOSH carefully reviewed the available evidence on lung
disease in coal miners. NIOSH also considered the strength of the
evidence, including the sampling and statistical analysis techniques
used, Criteria, Sec. 7.3.4, Rulemaking Record, Exhibit 2-1 at 124, and
concluded that the science provided a substantial basis for adopting a
permissible dust exposure limit. NIOSH summarized its findings based on
some of the studies detailed above, along with others, as follows:
In addition to the risk of simple CWP and PMF, epidemiological
studies have shown that coal miners have an increased risk of
developing COPD. COPD may be detected from decrements in certain
measures of lung function, especially FEV1 and the ratio of FEV1/
FVC. Decrements in lung function associated with exposure to coal
mine dust are severe enough to be disabling in some miners, whether
or not pneumoconiosis is also present. A severe or disabling
decrement in lung function is defined here as an FEV1 65% of
expected normal values; an impairment in lung function is defined as
an FEV1 80% of predicted normal values. An exposure-response
relationship between respirable coal mine dust exposure and
decrements in lung function has been observed in cross-sectional
studies and confirmed in longitudinal studies.
Criteria, 4.2.3.2 (citations omitted), Rulemaking Record, Exhibit 2-1
at 57. That coal mine dust exposure can cause obstructive lung disease
is now a well-documented fact.
Finally, the Department's position is consistent with the growing
body of case law recognizing that obstructive lung diseases can arise
from coal mine dust exposure. See generally Labelle Processing Co. v.
Swarrow, 72 F.3d 308, 315 (3d Cir. 1995) (``Chronic bronchitis, as a
chronic pulmonary disease, falls within the legal definition of
pneumoconiosis.''); Kline v. Director, OWCP, 877 F.2d 1175, 1178 (3d
Cir. 1989) (The legal definition of pneumoconiosis ``encompasses a
wider range of afflictions than does the more restrictive medical
definition of coal workers' pneumoconiosis.''); Richardson v. Director,
OWCP, 94 F.3d 164, 166 n.2 (4th Cir. 1996) (``COPD, if it arises out of
coal-mine employment, clearly is encompassed within the legal
definition of pneumoconiosis, even though it is a disease apart from
clinical pneumoconiosis.''); Warth v. Southern Ohio Coal Co., 60 F.3d
173, 175 (4th Cir. 1995) (``Chronic obstructive lung disease * * * is
encompassed within the definition of pneumoconiosis for purposes of
entitlement to Black Lung benefits.''); Barber v. Director, OWCP, 43
F.3d 899, 901 (4th Cir. 1995) (``physicians generally use
`pneumoconiosis' as a medical term that comprises merely a small subset
of the afflictions compensable under the Act''); Bethlehem Mines Corp.
v. Massey, 736 F.2d 120, 124 (4th Cir. 1984) (recognizing that
emphysema can be aggravated by coal dust exposure); Peabody Coal Co. v.
Holskey, 888 F.2d 440, 442 (6th Cir. 1989) (substantial evidence
supported ALJ's decision to credit doctor who believed miner's chronic
obstructive pulmonary disease was related to coal dust exposure over
doctor who believed the disease was caused solely by cigarette
smoking); Campbell v. Consolidation Coal Co., 811 F.2d 302, 304 (6th
Cir. 1987) (where miner had obstructive lung disease and no evidence
demonstrated it was not
[[Page 79944]]
related to coal mine employment, employer failed to rebut interim
presumption of entitlement); Freeman United Coal Mining Co. v. OWCP,
957 F.2d 302, 303 (7th Cir. 1992) (recognizing that the Act's
definition of pneumoconiosis encompasses obstructive disease caused in
whole or in part by exposure to coal dust); Old Ben Coal Co. v.
Prewitt, 755 F.2d 588, 591 (7th Cir. 1985) (recognizing that chronic
obstructive pulmonary disease ``fits the statutory definition'' of
pneumoconiosis); Associated Elec. Coop., Inc. v. Hudson, 73 F.3d 845,
847 (8th Cir. 1996) (affirming award of benefits based on medical
evidence of ``severe obstructive lung disease caused by coal dust
exposure''); Consolidation Coal Co. v. Hage, 908 F.2d 393, 395 (8th
Cir. 1990) (chronic obstructive lung disease ``constitutes a type of
ailment which Congress deems sufficient to entitle a claimant to Black
Lung benefits''); Bradberry v. Director, OWCP, 117 F.3d 1361, 1368
(11th Cir. 1997) (``COPD that arises from coal-mine employment falls
within the legal definition of pneumoconiosis.''); Stomps v. Director,
OWCP, 816 F.2d 1533, 1536 (11th Cir. 1987) (ordering award of benefits
on strength of medical opinion that miner's totally disabling chronic
obstructive pulmonary disease was caused in part by coal mine
employment).
Contrary to the commenters' argument, then, the record does contain
overwhelming scientific and medical evidence demonstrating that coal
mine dust exposure can cause obstructive lung disease. The Department
therefore declines to change the definition of pneumoconiosis as
proposed.
(g) One comment suggests that the Department delete the term
``anthracosis'' from the definition of pneumoconiosis, contending that
it is a term commonly used to denote anthracotic pigmentation, without
associated disease process, on biopsy or autopsy of the lungs. The
Department has accommodated this concern in the proposed revisions to
Sec. 718.202(a)(2). The revised version of Sec. 718.202(a)(2)
explicitly provides that ``[a] finding in an autopsy or biopsy of
anthracotic pigmentation * * * shall not be sufficient, by itself, to
establish the existence of pneumoconiosis.'' 64 FR 55013 (Oct. 8,
1999). Thus, the Department does not believe that a change to the
definition of pneumoconiosis is necessary.
(h) Several comments suggest that the Department appoint an expert
panel to review the scientific and medical evidence on the obstructive
disease, latency and progressivity proposed revisions to the
regulation. The Department declines to follow this suggestion. As set
forth above, the relevant scientific and medical information available
on these topics has been thoroughly reviewed by highly-qualified
experts, including NIOSH, the advisor designated by Congress to consult
with the Department in developing criteria for total disability due to
pneumoconiosis under the Black Lung Benefits Act. 30 U.S.C.
902(f)(1)(D). Accordingly, to the extent these commenters note that
``since coal-workers'' pneumoconiosis is a medical condition, * * *
this determination [establishing a proper definition of pneumoconiosis]
should be left to the medical experts,'' the comment ignores both the
statutory definition of pneumoconiosis and the large body of scientific
evidence already reviewed by medical experts, as outlined above.
(i) One comment criticizes the Department for not considering two
major sources of information regarding U.S. coal miners: the National
Coal Study, which the commenter states has provided a wealth of
longitudinal information about the health of miners, and the NIOSH X-
ray Surveillance Program. The commenter is incorrect. The information
from both of these programs is a major focus of NIOSH's Criteria
document, Rulemaking Record, Exhibit 2-1, and is further analyzed in
many of the articles considered by the Department and NIOSH in
proposing the revisions.
(j) One comment generally objects to the proposed revisions and
urges the Department to collect data developed by the Universities of
Kentucky and Louisville since the 1996 comprehensive reform of the
Kentucky state workers' compensation law, a program the commenter
states is based on objective medical findings of ``certified B
readers.'' The commenter believes that this data would more accurately
reflect modern day dust control in coal mining than the studies relied
upon by the Department. As discussed above, the Department's
conclusions are fully supported by the ample data it has already
reviewed, including data generated from time periods post-dating
implementation of federally-mandated dust control measures. Moreover,
the Department does not believe this information would be particularly
relevant to the proposed revisions of the definition of pneumoconiosis.
A ``certified B reader'' is a physician proved by examination to be
proficient in assessing the quality of chest X-rays and in using the
ILO-U/C system to classify X-rays for pneumoconiosis. 20 CFR
718.202(a)(1)(ii)(E) (1999). While this information may show the
incidence of clinical pneumoconiosis in a given population of coal
miners, it is not particularly relevant to the other subset of diseases
compensable under the Black Lung Benefits Act, namely, any chronic lung
disease arising out of coal mine employment.
(k) Another comment implies that the proposed definitional changes
adopt arbitrary medical ``presumptions'' without consultation with any
pulmonary experts. As discussed above, all of the scientific and
medical evidence upon which the Department relies has been thoroughly
reviewed and evaluated by experts in the field. It is not the
Department's intent to create a ``presumption'' with the proposed
revisions to the definition. Instead, the revisions are designed to
define pneumoconiosis in accordance with the best science currently
available to the Department while leaving with the miner the burden of
persuading the factfinder that he has a lung disease falling within
this definition.
(l) Two comments note that the proposed definition (at least
insofar as it recognizes that both obstructive and restrictive lung
disease may be caused by exposure to coal mine dust) was rejected by
Congress and should not be adopted. The Department has already
responded to this criticism. 64 FR 54972 (Oct. 8, 1999). No further
discussion is necessary.
(m) Two comments, while supporting the proposed changes, ask the
Department to amend the regulation further by requiring factfinders to
categorically reject as non-conforming any physician's opinion stating
either that coal dust cannot cause, or causes only trivial, obstructive
lung impairments, or that coal dust-induced lung diseases cannot
manifest themselves after a miner's exposure to coal mine dust ceases.
The commenters state that such a change would forestall parties
opposing miners' entitlement from needlessly prolonging litigation. A
physician's opinion based on a premise fundamentally at odds with the
statute and regulations is flawed, and the factfinder must weigh that
physician's opinion accordingly. See, e.g., Robinson v. Missouri Mining
Co., 955 F.2d 1181, 1183 (8th Cir. 1992); Penn Allegheny Coal Co. v.
Mercatell, 878 F.2d 106, 109-110 (3d Cir. 1989). This principle will
continue to govern under the revised regulation. Thus, the Department
does not believe a change to the proposed regulation is necessary.
(n) Several comments support the proposal, noting that the
revisions to the
[[Page 79945]]
definition of pneumoconiosis are supported by the current state of
medical knowledge.
(o) Two comments urge the Department to join the lawsuit filed by
the Department of Justice to recover money from the tobacco industry
for costs incurred by the black lung program for compensating and
treating smoking-related disabilities. The comment is not directed to
any regulatory proposal, and no response is warranted.
(p) No other comments were received concerning this section, and no
further changes have been made in it.
20 CFR 718.202
(a) In the initial notice of proposed rulemaking, the Department
proposed changing Sec. 718.202 only to the extent of clarifying that a
diagnosis of anthracotic pigment by biopsy, standing alone, is not
equivalent to a diagnosis of pneumoconiosis. Former Sec. 718.202(a)(2)
imposed this limitation with respect to autopsy evidence only, and the
Department noted there was no reason to treat the two types of evidence
differently. 62 FR 3345, 3376 (Jan. 22, 1997). The Department did not
propose any further changes to Sec. 718.202 in the second notice of
proposed rulemaking, although the regulation remained open for comment.
64 FR 54971 (Oct. 8, 1999).
(b) One comment supports the Department's proposed change as
consistent with mainstream scientific findings. Several other comments
support this change, but also advocate adopting the criteria for
diagnosing pneumoconiosis by autopsy or biopsy developed by the
American College of Pathologists and Public Health Service. For the
reasons set out in the preamble to Sec. 718.106, the Department cannot
make this change.
(c) Two comments urge the inclusion of language stating that a
negative chest x-ray cannot form the basis of a physician's reasoned
finding of no pneumoconiosis as the disease is defined in the statute
and regulations. The suggested addition is unnecessary for several
reasons. The Black Lung Benefits Act already prohibits the denial of a
claim solely on the basis of a negative x-ray. 30 U.S.C. 923(b). A
physician's opinion ruling out the presence of the disease based solely
on a negative x-ray would be similarly insufficient; such an opinion
would amount to no more than a repetition of the x-ray findings. See
Worhach v. Director, OWCP, 17 Black Lung Rep. 1-105, 1-110 (1993)
(physician's opinion which merely restates x-ray findings is not a
diagnosis of pneumoconiosis for purposes of Sec. 718.202(a)(4)).
Furthermore, Sec. 718.202(a)(4) already recognizes that a diagnosis of
pneumoconiosis may be made based on a documented and reasoned medical
opinion despite a negative x-ray. Warth v. Southern Ohio Coal Co., 60
F.3d 173, 174-75 n.* (4th Cir. 1995) (holding physician's opinion that
pneumoconiosis cannot be diagnosed absent positive x-ray or tissue
samples conflicts with Sec. 718.202(a)(4) because physician's diagnosis
may be based on other clinical evidence notwithstanding negative x-
ray). Finally, only a physician can determine the diagnostic value of a
negative x-ray in assessing the presence or absence of a respiratory or
pulmonary disease in a particular miner. The law only prohibits making
the negative x-ray the sole and conclusive basis for ruling out the
disease.
(d) One comment would limit relevant radiological qualifications to
board-certification in radiology and certification as a B-reader.
Although these two qualifications may encompass most physicians' expert
training, a rigid rule prohibiting consideration of any other aspect of
a physician's background is undesirable. The adjudicator should
consider any relevant factor in assessing a physician's credibility,
and each party may prove or refute the relevance of that factor. See
Worhach v. Director, OWCP, 17 Black Lung Rep. 1-105, 1-108 (1993)
(holding adjudicator may properly consider physician's professorship in
radiology in weighing radiological qualifications under
Sec. 718.202(a)(1)); compare Melnick v. Consolidation Coal Co., 16
Black Lung Rep. 1-31, 1-37 (1991) (en banc) (holding adjudicator may
not consider physician's ``prestigious teaching position'' outside the
field of radiology under Sec. 718.202(a)(1) in assessing physician's
radiological competence).
(e)(i) Three comments favor language recognizing that CT scans are
not reliable diagnostic tools for evaluating the presence or absence of
pneumoconiosis because no standardized criteria exist for interpreting
them. Another comment, however, argues that a negative CT scan
effectively precludes a diagnosis of pneumoconiosis because of its
level of clinical sophistication. General language accepting or
rejecting the use of CT scans is not necessary. The Department did not
propose any such language, or develop the record to ascertain the
medical community's views. The comments take diametrically opposite
views on the use of these tests, which provides no basis for adopting
either view. Furthermore, the Department favors consideration of new
and more accurate diagnostic technologies as they become available in
the future. See preamble to Sec. 718.107, 62 FR 3343 (Jan. 22, 1997).
Any party may support or challenge the probative value of a particular
test with expert opinions. No useful purpose would therefore be served
by adopting a blanket exclusion of any particular type of testing. (ii)
Based on the alleged unreliability of CT scans, two comments urge the
Department to make clear that a claimant may refuse to undergo a CT
scan without prejudicing the adjudication of his or her claim. The
Department rejects this position. The adjudicator should determine
whether a claimant's refusal to undergo a CT scan (or any other medical
test) is reasonable in light of all relevant circumstances in the
particular case. A general exoneration for all claimants refusing CT
scans is not warranted, especially since the Department does not
endorse the commenters' premise that this technology is necessarily
unreliable in the absence of standardized criteria for interpreting it.
(iii) One comment contends the CT scan is sufficiently reliable that a
negative result effectively rules out the existence of pneumoconiosis.
The statutory definition of ``pneumoconiosis,'' however, encompasses a
broader spectrum of diseases than those pathologic conditions which can
be detected by clinical diagnostic tests such as x-rays or CT scans.
See generally Island Creek Coal Co. v. Compton, F.3d, No. 98-2051, 2000
WL 524798, *4 (4th Cir. May 2, 2000) (reviewing medical and legal
definitions of ``pneumoconiosis,'' the latter of which is broader). For
purposes of the Black Lung Benefits Act, ``pneumoconiosis'' includes
any ``chronic dust disease of the lung and its sequelae, including
respiratory and pulmonary impairments, arising out of coal mine
employment.'' 30 U.S.C. 902(b). A CT scan may provide reliable evidence
in a particular claim that the miner does not have any evidence of the
disease which can be detected by that particular diagnostic technique.
The record, however, does not contain any medical evidence
demonstrating the capacity of CT scans to rule out the existence of all
diseases ``arising out of coal mine employment.'' See Compton, F.3d,
2000 WL 524798, *4 (noting that a medical diagnosis of no
pneumoconiosis is not equivalent to a diagnosis of no legal
pneumoconiosis), citing Hobbs v. Clinchfield Coal Co., 45 F.3d 819, 821
(4th Cir. 1995). The Department therefore cannot accept the commenter's
[[Page 79946]]
position that a negative CT scan is self-sufficient evidence that the
miner does not have ``pneumoconiosis'' for purposes of the statute.
(e) No other comments were received concerning this section, and no
changes have been made in it.
20 CFR 718.204
(a)(i) The Department proposed several significant changes to
Sec. 718.204 in the initial notice of proposed rulemaking. 62 FR 3344-
45, 3377-78 (Jan. 22, 1997). One revision clarified that ``total
disability'' does not take into consideration any disabling non-
respiratory conditions, i.e., a miner may be totally disabled for
purposes of the Black Lung Benefits Act (BLBA) notwithstanding the
existence of any independently disabling non-respiratory/pulmonary
impairments. This change emphasized the Department's disagreement with
Peabody Coal Co. v. Vigna, 22 F.3d 1388 (7th Cir. 1994) (holding
claimant's entitlement precluded by disabling stroke which was
unrelated to coal mine employment and occurred before evidence of
disability due to pneumoconiosis); contra Youghiogheny & Ohio Coal Co.
v. McAngues, 996 F.2d 130 (6th Cir. 1993), cert. den. 510 U.S. 1040
(1994) (holding miner's disabling injuries from automobile accident
irrelevant to disability determination under BLBA). Another revision
codified holdings in two circuits that ``disability'' for purposes of
the BLBA is a totally disabling respiratory or pulmonary impairment,
and not ``whole person'' disability. The Department also proposed a
definition for ``disability causation'' to harmonize the various
formulations of that standard in circuit court decisions: a miner is
totally disabled ``due to pneumoconiosis'' if the disease is a
``substantially contributing cause'' of the miner's disability.
Similarly, the Department proposed recognizing that pneumoconiosis may
worsen a totally disabling respiratory or pulmonary impairment which is
itself unrelated to coal mine employment. Finally, the Department
proposed a number of editorial changes to Sec. 718.204 to rationalize
its structure. 62 FR 3344-45 (Jan. 22, 1997). (ii) In the second notice
of proposed rulemaking, the Department proposed a minor revision to
Sec. 718.204(b)(2)(iv) by restoring language from 20 CFR 718.204(c)(4)
(1999), which had been omitted inadvertently. The language set forth
the circumstances under which a medical report may establish the
miner's total disability. 64 FR 54979, 55014 (Oct. 8, 1999). The
Department also responded to numerous comments it had received
concerning the proposed regulation. 64 FR 54979-80 (Oct. 8, 1999).
Several comments expressed both support for, and opposition to, the
Department's rejection of Vigna's holding that a pre-existing totally
disabling impairment which is unrelated to coal mine employment
precludes entitlement under the BLBA. The Department concluded the
commenters had provided no reason for changing the proposed regulation.
The Department also rejected comments which recommended adopting a
``whole person'' standard for total disability, rather than the
proposed definition limiting disability to pulmonary and respiratory
impairments. The commenters offered no rationale in support of the
requested change other than a statutory interpretation of ``total
disability'' previously rejected by two circuit courts in favor of the
Department's position. With respect to ``disability causation,'' the
Department rejected: challenges to its authority to define ``disability
due to pneumoconiosis'' given the statute's broad grant of rulemaking
authority and the ambiguity in the statutory term; various alternative
formulations of the disability causation standard in place of
``substantially contributing cause'' inasmuch as the Department's
definition reflected a general consensus in the existing caselaw; and
arguments that the ``substantially contributing cause'' standard
permitted awards based solely on smoking-related disability because
such awards are contrary to both the BLBA and judicial precedent. Other
than the restoration of language to Sec. 718.204(b)(2)(iv), the
Department did not propose any additional changes to Sec. 718.204. 64
FR 54979-80 (Oct. 8, 1999).
(b) In both the first and second notices of proposed rulemaking,
the Department proposed identical language defining total disability
due to pneumoconiosis. 62 FR 3345, 3377; 64 FR 54979-54980, 55014. The
Department explained its authority to define this statutory element of
entitlement and proposed using a substantially contributing cause
standard. Thus, a miner would be found totally disabled due to
pneumoconiosis if he establishes that his pneumoconiosis is a
substantially contributing cause of his totally disabling respiratory
or pulmonary impairment. In both proposals, the Department explained
that this standard was based on court of appeals precedent which had
developed since 1989 and varied very little from circuit to circuit.
The Department also proposed that pneumoconiosis be considered a
substantially contributing cause of the miner's disability if it either
has an adverse effect on the miner's respiratory or pulmonary condition
or worsens a totally disabling respiratory or pulmonary impairment
caused by a disease or exposure unrelated to coal mine employment.
Secs. 718.204(c)(1)(i), 718.204(c)(1)(ii). In neither proposal did the
Department describe the extent to which pneumoconiosis must have
produced an adverse effect or worsened a totally disabling respiratory
impairment. The Department did not mean to alter the current law
through its proposals, however, or to suggest that any adverse effect,
no matter how limited, was sufficient to establish total disability due
to pneumoconiosis. Rather, the Department meant only to codify the
numerous decisions of the courts of appeals which, in the process of
deciding when a miner is totally disabled due to pneumoconiosis, have
also ruled on what evidence is legally sufficient to establish that
element of entitlement. In order to clarify this consistent intent, the
Department has added the word ``material'' to Sec. 718.204(c)(1)(i) and
``materially'' to Sec. 718.204(c)(1)(ii). In so doing, the Department
intends merely to implement the holdings of the courts of appeals.
Thus, evidence that pneumoconiosis makes only a negligible,
inconsequential, or insignificant contribution to the miner's total
disability is insufficient to establish that pneumoconiosis is a
substantially contributing cause of that disability.
The Department is also mindful, however, that Congress enacted the
Act in large part to permit benefit awards to miners whose entitlement
under state workers' compensation laws was precluded by burdensome
causation requirements. Adams v. Director, OWCP, 886 F.2d 818, 825 (6th
Cir. 1989); Mangus v. Director, OWCP, 882 F.2d 1527, 1530-1531 (10th
Cir. 1989). Moreover, the courts have also recognized the difficulties
that would confront a miner who must prove the relative amounts that
various causal elements contribute to his totally disabling respiratory
or pulmonary impairment. See Compton v. Inland Steel Coal Co., 933 F.2d
477, 481-483 (7th Cir. 1991); Adams, 886 F.2d at 825; Mangus, 882 F.2d
at 1530-1531. The courts have held that a claim will not be denied
simply because a physician reasonably may be unwilling or unable to
account, as a percentage or otherwise, for the exact degree of
impairment caused by pneumoconiosis. See, e.g., Barger v. Abston
Constr. Co., 196 F.3d 1261 (11th Cir. 1999) (Table) (opinion
[[Page 79947]]
that pneumoconiosis was ``at least a partial contributing cause'' of
miner's disability sufficient to prove disability due to
pneumoconiosis); Cross Mountain Coal Co. v. Ward, 93 F.3d 211, 218 (6th
Cir. 1996) (opinion that miner's ``impairment is due to his combined
dust exposure, coal workers'' pneumoconiosis as well as his cigarette
smoking history'' sufficient); Benjamin Coal Co. v. McMasters, 27 F.3d
555 (3d Cir. 1994) (Table) (opinions that (1) pneumoconiosis was the
``least significant'' factor contributing to miner's disability, and
(2) coal dust exposure and cigarette smoking contributed to miner's
impairment but doctor was unable ``to differentiate between the effects
of the two causes'' sufficient); Compton v. Inland Steel Coal Co., 933
F.2d 477, 479 (7th Cir. 1991) (opinion that ``pneumoconiosis * * * was
one of the conditions that brought about the pulmonary impairment''
sufficient); Robinson v. Pickands Mather & Co., 914 F.2d 35, 36 (4th
Cir. 1990) (opinion that miner's ``disability was consistent with
occupational pneumoconiosis'' sufficient); Lollar v. Alabama By-
Products Corp., 893 F.2d 1258, 1267 (11th Cir. 1989) (physician's
diagnosis of ``restrictive pulmonary functions and pleural disease by
chest x-ray with minimal parenchymal disease, all of which is
consistent with coal workers' pneumoconiosis,'' sufficient); Adams v.
Director, OWCP, 886 F.2d 818, 826 (6th Cir. 1989) (diagnosis of ``total
disability resulting from a combination of pneumoconiosis, emphysema
and chronic obstructive lung disease'' sufficient); Bonessa v. United
States Steel Corp., 884 F.2d 726 (3d Cir. 1989) (opinion that
pneumoconiosis made a ``substantial contribution'' to miner's
disability sufficient); Mangus v. Director, OWCP, 882 F.2d 1527 (10th
Cir. 1989) (evidence that miner's pneumoconiosis caused complications
requiring removal of entire lung during surgery intended to remove only
part of lung as treatment of lung cancer, sufficient).
(c)(i) One comment states the Department has not justified its
revision of Sec. 718.204(a) making disabling non-pulmonary/respiratory
impairments irrelevant in determining whether a miner is totally
disabled under the BLBA. The Department has previously addressed this
issue in both the initial and second notices of proposed rulemaking. 62
FR 3344-45 (Jan. 22, 1997); 64 FR 54979 (Oct. 8, 1999). In both
instances, the Department cited McAngues, 996 F.2d 130, as authority
for its view that non-pulmonary/respiratory impairments cannot be
considered in a disability determination. McAngues, 996 F.2d at 134-35,
quotes with approval the following language from Twin Pines Coal Co. v.
U.S. Dept. of Labor, 854 F.2d 1212 (10th Cir. 1988):
* * * [A] review of the cases, the statute, its legislative
history, and its interpretation by the benefits review board * * *
shows that the statute is intended to confer special benefits on
miners who are disabled due to pneumoconiosis whether or not they
are disabled from a different cause. Even when other causes are
themselves independently disabling `[t]he concurrence of two
sufficient disabling medical causes one within the ambit of the Act,
and the other not, will in no way prevent a miner from claiming
benefits under the Act.'
854 F.2d at 1215, quoting Peabody Coal Co. v. Director, OWCP
[Huber], 778 F.2d 358, 363 (7th Cir. 1985); see also Cross Mountain
Coal Co. v. Ward, 93 F.3d 211, 217 (6th Cir. 1996). This line of
authority from three federal courts of appeals fully supports the
Department's revision of Sec. 718.204(a). Although Vigna adopts a
contrary interpretation of the BLBA, the Seventh Circuit did not
address its own precedent in Huber or the contrary decisions in
McAngues and Twin Pines. Accordingly, the Department does not consider
Vigna a sufficient basis for altering the regulation. (ii) Several
comments support the Department's position.
(d) One comment contends the limitations on introducing evidence
concerning non-respiratory or pulmonary impairments deprive the ``but
for'' disability causation standard of any practical meaning in terms
of proving that pneumoconiosis played little, if any, role in the
miner's disability. The Department disagrees with the commenter's
position for two reasons. First, the Department has adopted a
``substantially contributing cause'' standard, which is not the
equivalent of a ``but for'' standard. ``Substantially contributing
cause'' means pneumoconiosis has a material adverse effect on a miner's
respiratory or pulmonary condition (Sec. 718.204(c)(1)(i)). This
standard is less rigorous than a ``but for'' test. Second, only
respiratory and pulmonary impairments are relevant to determining
whether the miner is totally disabled for purposes of the Black Lung
Benefits Act, and identifying the causes of that disability. The
commenter's position effectively rests on the Seventh Circuit's
interpretation of disability causation in Peabody Coal Co. v. Vigna, 22
F.3d 1388 (7th Cir. 1994). In that decision, the Court held a miner's
entitlement to benefits was precluded by his disabling stroke because
the stroke was unrelated to coal mine employment and occurred before
any evidence the miner was disabled by pneumoconiosis. The Department
disagrees with Vigna. Non-respiratory or pulmonary disabilities may co-
exist with total disability due to pneumoconiosis, but the former are
irrelevant for purposes of determining whether a miner is entitled to
black lung benefits. Consequently, non-respiratory or pulmonary
impairments have no relevance to the disability causation standard, and
the limitation on introducing evidence concerning such conditions is
appropriate.
(e) Three comments oppose the revised definition of ``total
disability'' to the extent it requires proof of a totally disabling
respiratory or pulmonary impairment. The commenters urge the Department
to adopt a definition which incorporates a ``whole person'' definition
of disability, i.e., total disability based on a combination of
pneumoconiosis and any other physical impairments which prevent the
miner from performing his or her usual coal mine work or comparable and
gainful work. The Department has previously rejected the ``whole
person'' standard in both the initial and second notices of proposed
rulemaking. 62 FR 3345 (Jan. 22, 1997); 64 FR 54979 (Oct. 8, 1999). The
Department has consistently taken the position that proof of a totally
disabling respiratory or pulmonary impairment is an essential element
of a miner's claim for black lung benefits. See, e.g., Beatty v. Danri
Corp. & Triangle Enter., 49 F.3d 993, 1001 (3d Cir. 1995); Jewell
Smokeless Coal Corp. v. Street, 42 F.3d 241, 243 (4th Cir. 1994);
Lollar v. Alabama By-Products Corp., 893 F.2d 1258, 1262-1263 (11th
Cir. 1990); Bosco v. Twin Pines Coal Co., 892 F.2d 1473, 1480 (10th
Cir. 1989); Adams v. Director, OWCP, 886 F.2d 818, 820 (6th Cir. 1989).
Adoption of a ``whole person'' definition of total disability would
greatly expand the black lung benefits program and transform it into a
general disability program for coal miners. The Department is convinced
such a result has never been the intent of Congress. Moreover, unlike
the Social Security Administration which has regulations, procedures,
and personnel devoted to the evaluation of impairments from the ``whole
person'' perspective, the Department simply is not equipped to evaluate
such impairments. The Department's approach to the definition of total
disability is not undermined by the allowance of survivors' claims
where death was due in part to nonrespiratory or nonpulmonary
[[Page 79948]]
conditions but was actually hastened by pneumoconiosis.
Allowance of survivors' claims in such situations is consistent
with the legislative history of the 1981 amendments to the BLBA. 62 FR
3345 (Jan. 22, 1997); 48 FR 24276-77 (May 31, 1983), In addition, the
determination of whether pneumoconiosis actually hastened death in a
given case does not require the types of regulations, procedures and
personnel that would be required by a ``whole person'' disability
definition.
(f) One comment opposes the requirement in Sec. 718.204(b)(2)(iv)
that a physician's opinion must be documented as well as reasoned in
order to establish the existence of a totally disabling respiratory or
pulmonary impairment. The commenter states that an opinion should be
considered sufficient if it is ``reasoned.'' The commenter also
criticizes the regulation for failing to define the requisite
documentation. The commenter does not state a basis for changing the
regulation. The most fundamental requirement for any physician's
opinion is that it identify the information and data upon which the
physician relies in order to form a judgment about the miner's
pulmonary condition. Unless the adjudicator is aware of the
documentation, (s)he is in no position to determine whether the opinion
is ``reasoned.'' A physician provides a ``reasoned'' opinion by
explaining conclusions in light of factual premises which consist of
personal and occupational information about the miner and the results
of clinical tests and a physical examination, i.e., the
``documentation.'' See generally Director, OWCP v. Rowe, 710 F.2d 251,
255 (6th Cir. 1983). If one or more of the premises is faulty or
inconsistent with the conclusions reached by the physician, the
adjudicator may find the opinion not credible. Contrary to the
commenter's position, a physician's reasoning cannot be divorced from
the underlying documentation. As for defining the necessary
documentation, Sec. 718.104(a) sets forth the basic requirements for
any report of physical examination obtained in connection with a claim
for black lung benefits, and subsection (b) accommodates any additional
testing the physician may consider useful.
(g) One comment challenges the Department's authority to promulgate
a disability causation standard. The commenter also contends the
Department cannot adopt a causation standard which permits a finding of
total disability due to pneumoconiosis if the miner's pneumoconiosis
worsens a totally disabling respiratory or pulmonary impairment which
is itself unrelated to coal mine employment. Sec. 718.204(c)(1)(ii).
The Department rejects both positions. The Department has previously
addressed comments contesting its authority to issue a regulation
defining disability causation in the second notice of proposed
rulemaking. 64 FR 54979-80 (Oct. 8, 1999). The Department cited the
explicit rulemaking authority conferred by Congress in 30 U.S.C.
902(f)(1), which makes ``total disability'' subject to the meaning
established by the Department through regulations. The Department also
noted that benefits may be paid for total disability ``due to
pneumoconiosis,'' 30 U.S.C. 922(a)(1), but that ``due to'' is ambiguous
and therefore a valid subject for regulatory interpretation. With
respect to the ``worsening'' standard, the Department adopted this
definition in response to the Fourth Circuit's decision in Dehue Coal
Co. v. Ballard, 65 F.3d 1189 (4th Cir. 1995). In that decision, the
Court held that a miner who had totally-disabling lung cancer was not
entitled to benefits because his pneumoconiosis, by definition, could
not contribute to his disability. The Department believes a miner
should not be denied benefits if the miner's pneumoconiosis causes
further deterioration of a totally disabling (non-occupationally
related) pulmonary or respiratory impairment. Although the effect is
cumulative or additive, the pneumoconiosis nevertheless further
diminishes the miner's already-compromised lung function. The
Department stresses that this causation standard does not require an
award of benefits simply because the miner has pneumoconiosis and the
pneumoconiosis adversely affects his or her pulmonary condition. No
award is permitted if there is not also present a totally disabling
respiratory or pulmonary impairment. In such a case, the miner is
entitled to benefits because (s)he is totally disabled and
pneumoconiosis is a part of the overall disabling condition.
(h) Three comments contend generally that the disability causation
standard promotes awards for smoking-induced disability. The Department
has previously considered, and rejected, the same contention in the
second notice of proposed rulemaking. 64 FR 54980 (Oct. 8, 1999). The
BLBA, judicial precedent, and the program regulations do not permit an
award based solely on smoking-induced disability. Because the
commenters do not state any additional grounds for their contention, no
further response is necessary.
(i) One comment suggests the role of smoking in causing disability
undermines the regulatory presumptions by negating the validity of
their factual premises. Specifically, the commenter argues that the
rational connection between established and presumed facts is broken if
the miner smoked. The Department disagrees with this analysis. The
presumptions contained in Secs. 718.302-718.306 are all derived from
the BLBA. See 30 U.S.C. 921(c)(1) [implemented by Sec. 718.302];
921(c)(2) [implemented by Sec. 718.303]; 921(c)(3) [implemented by
Sec. 718.304]; 921(c)(4) [implemented by Sec. 718.305]; 921(c)(5)
[implemented by Sec. 718.306]. The regulatory presumptions are
therefore authorized by the statute itself. The Supreme Court has
upheld the constitutionality of 30 U.S.C. 921(c)(1)-(4) in Usery v.
Turner Elkhorn Mining Co., 428 U.S. 1, 22-31 (1976). In the 1981
amendments to the BLBA, Congress limited the applicability of 30 U.S.C.
921(c)(2) and (4) to claims filed before January 1, 1982, and 921(c)(5)
to claims filed before June 30, 1982. Consequently, three of the
statutory presumptions have little effect on the adjudication of black
lung claims at this time. The Department also does not accept the
commenter's premise that allegedly widespread cigarette smoking among
miners has effectively destroyed the basis for the presumptions. If any
individual miner's smoking is proven the sole cause of his or her
disability, death or disease, the party opposing entitlement has
rebutted the presumption (except with respect to Sec. 718.304, which is
irrebuttable). The presumption itself is not invalid if the presumed
fact is disproved; rather, the evidence simply establishes that the
presumed facts are not true in the particular case. Accordingly, the
Department rejects the commenter's view that the incidence of smoking
among miners necessarily causes constitutional infirmities in the
regulatory presumptions.
(j) One comment urges the Department to join the lawsuit filed by
the Department of Justice to recover money from the tobacco industry
for benefits approved by the Department based on disability caused by
cigarette smoking. The comment is not directed to any regulatory
proposal, and no response is warranted.
(k) One comment supports the ``substantially contributing cause''
standard.
(l) No other comments have been received concerning this section,
and no changes have been made in it.
[[Page 79949]]
20 CFR 718.205
(a) In the initial notice of proposed rulemaking, the Department
proposed codifying its position, unanimously supported by circuit court
precedent, that recognizes a causal relationship between a miner's
death and pneumoconiosis if the disease hastened the miner's death. 62
FR 3345-46, 3378 (Jan. 22, 1997). The Department responded to the
comments received when it issued the second notice of proposed
rulemaking. 64 FR 54980 (Oct. 8, 1999). Several comments urged the
Department to reinstate automatic entitlement for survivors of miners
who were totally disabled by pneumoconiosis, but did not die from that
disease (so-called ``unrelated death benefits''); one comment concluded
the Department had effectuated that result by adopting the ``hastening
death'' standard in Sec. 718.205(c)(5). The Department rejected the
first suggestion because the 1981 amendments to the Black Lung Benefits
Act (BLBA) allow benefits in survivors' claims filed after January 1,
1982, only if the miner died due to pneumoconiosis. Similarly, the
Department disagreed with the commenter's interpretation of the
``hastening death'' standard, citing its universal acceptance by the
six circuits with jurisdiction over 90 percent of black lung claims
litigation. The Department also rejected a recommendation that it make
applicable to claims filed after January 1, 1982, a more lenient
regulatory standard applicable to claims filed before 1982, since the
standard was based on a statutory presumption (30 U.S.C. 921(c)(2))
repealed by Congress in the 1981 amendments. The Department did not
propose any further changes to Sec. 718.205 in the second notice of
proposed rulemaking, although the regulation remained open for further
comment. 64 FR 54971 (Oct. 8, 1999).
(b) One comment opposes the ``hastening death'' standard because it
reinstates survivors' ``unrelated death benefits.'' The commenter
states broadly that any lingering, non-traumatic, death will be
affected by every disease process present in the individual. The
Department disagrees. The commenter does not cite any medical support
for its position, and it does not respond to the Department's
explanation rejecting any similarity between the ``hastening death''
standard and ``unrelated death benefits'' in the second notice of
proposed rulemaking. 64 FR 54980 (Oct. 8, 1999). Moreover, the
commenter's premise overlooks the role of the claims adjudication
process, which requires the claimant to submit credible medical
evidence establishing a detectable hastening of the miner's death on
account of pneumoconiosis. The party opposing entitlement has ample
opportunity in each survivor's claim to submit evidence proving
pneumoconiosis played no role in the miner's death.
(c) One comment argues that at least half of approved survivors'
claims are based on deaths attributable to the adverse health effects
of smoking. The commenter recommends reallocating the costs of these
claims to the tobacco industry. The comment is not directed toward any
regulatory proposal, and no response is warranted.
(d) Two comments generally assert the ``hastening death'' standard
cannot be implemented by the Department because the regulation violates
the notice and comment provisions of the Administrative Procedure Act
(APA), 5 U.S.C. 551 et seq. The commenters do not indicate in what
manner these APA requirements have been violated. Assuming the
commenters are asserting the Department improperly adopted the
``hastening death'' standard in litigation rather than through
rulemaking, the Department disagrees. The Department promulgated 20 CFR
718.205 in 1983, after complying with the APA's notice and comment
provisions, in response to the 1981 amendments to the BLBA. 48 FR 24272
(May 31, 1983). Under those amendments, a deceased miner's survivor who
filed a claim on or after January 1, 1982, is eligible for benefits
only if the miner's death was due to pneumoconiosis. Based on the
legislative history of the 1981 amendments, the Department provided
that death will be considered ``due to pneumoconiosis'' where
pneumoconiosis was at least ``a substantially contributing cause or
factor.'' 20 CFR 718.205(c)(2) (1999). In later litigation, the
Department set forth its interpretation of the regulatory phrase
``substantially contributing cause or factor,'' and consistently
maintained that this standard is met by evidence proving pneumoconiosis
actually hastened the miner's death. The ``hastening death'' standard
gives practical meaning to the phrase ``substantially contributing
cause.'' See Bradberry v. Director, OWCP, 117 F.3d 1361, 1365-66 (11
Cir. 1997) and cases cited therein. The Department is the administrator
of the BLBA and, in that role, has the authority to interpret its own
regulations. Indeed, because the Department's interpretation is
reasonable and consistent with the regulatory language, every court of
appeals to have considered the question has deferred to the
Department's interpretation. Bradberry, 117 F.3d 1361, 1366-67;
Northern Coal Co. v. Director, OWCP, 100 F.3d 871, 874 (10th Cir.
1996); Brown v. Rock Creek Mining Co., 996 F.2d 812, 816 (6th Cir.
1993); Peabody Coal Co. v. Director, OWCP, 972 F.2d 178, 183 (7th Cir.
1992); Shuff v. Cedar Creek Coal Co., 967 F.2d 977, 980 (4th Cir.
1992), cert. den. 506 U.S. 1050 (1993); Lukosevicz v. Director, OWCP,
888 F.3d 1001, 1006 (3d Cir. 1989). Accordingly, the ``hastening
death'' standard is a permissible interpretation of Sec. 718.205(c)(2),
which was promulgated after public notice and comment in accordance
with the APA.
(e) Two comments contend the Department cannot apply
Sec. 718.205(c)(5) to pending claims without violating a prohibition on
retroactive rulemaking. (i) The Department previously addressed the
retroactivity issue in the initial notice of proposed rulemaking. 62 FR
3347-48 (Jan. 22, 1997). The Department acknowledged the Supreme
Court's holding in Bowen v. Georgetown University Hospital, 488 U.S.
204, 208 (1988), which limits the retroactive applicability of agency
regulations unless Congress has expressly authorized such regulations.
Although the Black Lung Benefits Act (BLBA) does not contain the
express statutory authority required by Bowen, the Department concluded
many of the proposed regulations could nevertheless apply to pending
claims. These regulations, or revisions to regulations, principally
clarify the Department's interpretation of the BLBA and the current
program regulations. Revised regulations which could significantly
change the regulated community's existing obligations and expectations,
however, apply only prospectively to claims filed after the effective
date of the final regulations. The Department reiterated this position
in the second notice of proposed rulemaking. 64 FR 54981-82 (Oct. 8,
1999). It rejected recommendations to make all of the revisions either
fully retroactive or entirely prospective. The Department adhered to
its earlier explanation in the initial notice of proposed rulemaking:
some regulations could apply to pending claims because they codify
existing agency interpretations of the BLBA and regulations, while
other regulations must be limited to prospective application because
they involve significant changes to the existing program which could
disrupt the parties' interests. The Department therefore declined to
adopt a single approach for all of the revisions. Finally, the
Department rejected arguments against retroactive
[[Page 79950]]
rulemaking premised on the Contract Clause of the United States
Constitution, art. I, Sec. 10, cl. 1, and the impairment of contracts.
64 FR 54981-82 (Oct. 8, 1999). (ii) The most recent comments do not
cite any legal authority contradicting the Department's extensive
analysis of the retroactivity issues in the initial and second notices
of proposed rulemaking. In any event, the Department's analysis remains
valid. An agency regulation does not run afoul of Bowen simply because
it may operate retroactively. ``So long as a change in a regulation
does not announce a new rule, but rather merely clarifies or codifies
an existing policy, that regulation can apply retroactively. A rule
clarifying an unsettled or confusing area of the law `does not change
the law, but restates what the law according to the agency is and has
always been' * * * [.]'' Orr v. Hawk, 156 F.3d 651, 654 (6th Cir.
1998), reh'g en banc den., 172 F.3d 411 (6th Cir. 1999), quoting Pope
v. Shalala, 998 F.2d 473, 483 (7th Cir. 1993). See also First National
Bank of Chicago v. Standard Bank & Trust, 172 F.3d 472, 478 (7th Cir.
1999) (noting Bowen's ban on retroactivity is inapplicable if rule is
clarification rather than legislative change); compare National Mining
Assoc. v. U.S. Dept. of Interior, 177 F.3d 1, 8 (D.C. Cir. 1999)
(agency rule interpreting statute to impose liability for pre-rule acts
gives retroactive effect which Bowen prohibits absent express statutory
authority). As the Department explained in both the initial and second
notices of proposed rulemaking, Sec. 718.205(c)(5) simply codifies the
Department's longstanding interpretation of the legal standard for
proving a miner's pneumoconiosis was a ``substantially contributing
cause'' of his or her death under the BLBA and part 718 regulations. 62
FR 3345-46 (Jan. 22, 1997); 64 FR 54980 (Oct. 8, 1999). Six circuit
courts have adopted this interpretation while no court has disagreed.
Bradberry v. Director, OWCP, 117 F.3d 1361, 1365-66 (11th Cir. 1997);
Northern Coal Co. v. Director, OWCP, 100 F.3d 871, 874 (10th Cir.
1996); Brown v. Rock Creek Mining Co., 996 F.2d 812, 816 (6th Cir.
1993); Peabody Coal Co. v. Director, OWCP, 972 F.2d 178, 183 (7th Cir.
1992); Shuff v. Cedar Creek Coal Co., 967 F.2d 977, 980 (4th Cir.
1992), cert. den. 506 U.S. 1050 (1993); Lukosevicz v. Director, OWCP,
888 F.2d 1001, 1006 (3d Cir. 1989); but see Tackett v. Armco, Inc., 16
Black Lung Rep. 1-88, 1-93 (1992), vacated on remand 17 Black Lung Rep.
1-103, 1-104 (1993) (rejecting ``hastening death'' standard, but
vacating opinion on remand in light of controlling decision in Shuff).
Section 718.205(c)(5) therefore represents a clarifying regulation
which the Department may validly implement with retroactive effect for
claims pending on the date the regulation becomes effective. (iii)
Based on the foregoing analysis, the Department also rejects one
commenter's position that the BLBA requires a ``direct cause and effect
relationship'' between the miner's pneumoconiosis and death in order
for a survivor to be entitled to benefits, at least insofar as the
commenter would require that pneumoconiosis be the immediate, sole and
proximate cause of the miner's death. Pneumoconiosis may be the direct,
or proximate, cause of a miner's death (Sec. 718.205(c)(1)), but
entitlement may also be premised on the lesser ``hastening death''
standard (Sec. 718.205(c)(2), (5)). The circuit court precedents cited
above have unanimously upheld this interpretation. In both cases, a
``direct'' effect links the pneumoconiosis to the miner's death, i.e.,
either as the leading, or contributing, cause of the miner's death. The
Department's interpretation reflects Congressional intent that benefits
be awarded if the survivor establishes that pneumoconiosis was a
contributing cause of the miner's death, although not the sole and
immediate cause. See 45 FR 13690 (Feb. 29, 1980); 48 FR 24276-78 (May
31, 1983).
(f) The Department received written comments and expert hearing
testimony from physicians on the role pneumoconiosis may play in a
miner's death. (i) Expert Comments. Drs. Ben V. Branscomb,
Distinguished Professor Emeritus, University of Alabama (Birmingham),
and William C. Bailey, Professor of Medicine and Eminent Scholar, Chair
in Pulmonary Disease, University of Alabama (Birmingham), (Rulemaking
Record Ex. 5-174, Appendix 8), comment that the medical literature does
not substantiate any hastening effect of simple pneumoconiosis on the
timing of a miner's death. They do acknowledge that severe complicated
pneumoconiosis could have an additive effect in some instances, but
only by reducing the miner's lifespan marginally. The physicians
conclude that pneumoconiosis usually does not affect a miner's death
from non-lung disease conditions, nor does mild or moderate stable
pulmonary insufficiency affect other diseases leading to death. At the
Department's Washington, D.C., public hearing, Dr. Branscomb also
observed that simple pneumoconiosis has no effect on the common causes
of death, and does not otherwise influence the course of a miner's
death. Rulemaking Record (Ex. 35), Transcript, Hearing on Proposed
Changes to the Black Lung Program Regulations (July 22, 1997), pp 47-
48. At the same hearings, Dr. Robert Cohen, Chief, Division of
Pulmonary Medicine, Cook County (IL) Hospital, generally described the
means by which impairment of lung function from pneumoconiosis could
weaken the body's defenses to infections and increase susceptibility to
other disease processes. Rulemaking Record (Ex. 35), Transcript (July
23, 1997), pp 421-23. Dr. Gregory J. Fino, board-certified in Internal
Medicine and in the subspecialty of Pulmonary Disease, (Rulemaking
Record, Ex. 89-37, Appendix C), notes several studies which have shown
that complicated pneumoconiosis is a cause of death, while other
studies provide less authoritative evidence that simple pneumoconiosis
may be a cause of death. This physician concludes that pneumoconiosis
may be implicated in a miner's death provided the death is respiratory-
related and the pneumoconiosis has caused respiratory dysfunction
during the miner's life. With respect to non-respiratory deaths, Dr.
Fino states that the medical literature does not document any
contributory relationship between death and pneumoconiosis. (ii)
Scientific literature. One of the principal scientific documents cited
by the Department in both the initial and second notices of proposed
rulemaking is the National Institute of Occupational Safety and
Health's (NIOSH) Criteria for a Recommended Standard, Occupational
Exposure to Respirable Coal Mine Dust (1995) (Criteria). 62 FR 3343
(Jan. 22, 1997); 64 FR 54978-79 (Oct. 8, 1999); Rulemaking Record,
Exhibit 2-1. NIOSH cited studies from the United States and the United
Kingdom which documented increases in mortality among miners from lung
diseases related to respirable dust. Criteria, Sec. 4.2.5.1, Rulemaking
Record, Exhibit 2-1 at 63-64, citing Miller BG, Jacobsen M, ``Dust
exposure, pneumoconiosis, and mortality of coal miners,'' Br J Ind Med
42:723-733 (1985), and Keumpel ED, et al., ``An exposure-response
analysis of mortality among U.S. miners,'' Am J Ind Med 28(2):167-184
(1995). Miller and Jacobson noted ``significant'' increases in
mortality among U.K. miners with radiographic evidence of progressive
massive fibrosis, and ``slightly decreased'' survival rates among
miners with radiographic evidence of simple pneumoconiosis compared to
miners without pneumoconiosis. Kuempel et
[[Page 79951]]
al. found increases in pneumoconiosis mortality among U.S. miners with
progressive massive fibrosis, simple pneumoconiosis and exposure to
dust of higher-rank coals. Based on these studies, NIOSH concluded:
``[M]iners with working lifetime exposures to respirable coal mine dust
at a mean concentration of 2 mg/m3 have an increased risk of
dying from pneumoconiosis, chronic bronchitis, or emphysema.''
Criteria, Sec. 4.2.5.1, Rulemaking Record, Exhibit 2-1 at 64. In the
second notice of proposed rulemaking, the Department referenced another
study which NIOSH had cited to the Department, Coggon D, et al., ``Coal
mining and chronic obstructive pulmonary disease: a review of the
evidence,'' Thorax 53:398-407 (1998); see also 64 FR 54979 (Oct. 8.
1999). The authors reviewed studies on mortality in coal miners and
reported that mortality attributed to chronic obstructive pulmonary
disease was higher in miners than the general population. Among the
studies submitted by one commenter is Green FHY, Vallyathan V, ``Coal
Workers' Pneumoconiosis and Pneumoconiosis Due to Other Carbonaceous
Dusts,'' in Chung A, Green FHY, eds., Pathology of Occupational Lung
Disease (2d ed. 1998) 129; see also Rulemaking Record, Exhibit 89-21,
attachment 2. Green and Vallyathan state that ``[a]pproximately 4% of
coal miner deaths are directly attributable to pneumoconiosis,'' but
note that the ``excess mortality rate from pneumoconiosis'' is
primarily attributable to progressive massive fibrosis. (p. 137). The
authors further note, however, that ``[d]eath from pneumoconiosis,
chronic bronchitis, and emphysema has been related to cumulative dust
exposure,'' citing Miller and Jacobson, and Kuempel et al. In contrast,
Parker and Banks conclude, ``a series of mortality reports have not
convincingly shown that simple [coal workers' pneumoconiosis] is
associated with premature mortality, but that [progressive massive
fibrosis] adversely affects survival * * *.'' Parker, Banks, ``Lung
diseases in coal workers,'' Occupational Lung Disease (1998); see also
Rulemaking Record, Exhibit 89-21, attachment 3. Parker and Banks also
cite the results of the study by Kuempel et al. See also Morgan WKC,
``Dust, Disability, and Death,'' Am Rev Resp Dis 134:639, 641 (1986);
Rulemaking Record, Exhibit 89-21, attachment 8 (concluding more
emphasis should be placed on reducing cigarette smoking among miners
than dust levels in mines to reduce mortality). (iii) By incorporating
the ``hastening death'' standard into the regulation, the Department is
clarifying the applicable statutory standard: a survivor is entitled to
benefits if the miner's death was due to pneumoconiosis. This standard,
in the Department's view as well as in the unanimous view of the
circuit courts of appeals that have considered it, accords with
Congress' intent to compensate survivors of miners whose deaths were in
some way related to pneumoconiosis, as that term is broadly defined by
the statute. The Department emphasizes, however, that the survivor must
establish that the miner's death was hastened by pneumoconiosis in each
case. The Rulemaking Record, including the variety of expert medical
comments, studies and opinions on the potential contributory role of
pneumoconiosis in the deaths of coal miners, does not demonstrate the
necessity to depart from the hastening death legal standard. These
views appear relatively consistent in stating that complicated
pneumoconiosis (also called progressive massive fibrosis) may
contribute to a miner's death given the severity of the disease. While
opinions differ as to the possibility that simple pneumoconiosis can
adversely affect the mortality process, the Department is persuaded by
NIOSH's conclusion that the mortality studies it reviewed substantiate
an increased risk of death from respiratory diseases which may be
encompassed within the BLBA's definition of ``pneumoconiosis.'' NIOSH
is the government agency charged with conducting research into
occupationally-related health problems. In that capacity, the
Department has previously consulted with NIOSH concerning issues
related to the proposed definition of pneumoconiosis in Sec. 718.201.
64 FR 54978-79 (Oct. 8, 1999); see also 30 U.S.C. 902(f)(1)(D)
(Department to consult with NIOSH on criteria for tests which establish
total disability in miners). The Department therefore considers NIOSH's
view particularly significant in evaluating the conflicting medical
opinions concerning the ``hastening death'' standard, especially since
its views are consistent with other studies submitted into the record.
To the extent the commenters express the view that simple
pneumoconiosis can never cause death, such views are inconsistent with
the BLBA. The statute contemplates an award of benefits based upon
proof of pneumoconiosis as defined in the statute (which encompasses
simple pneumoconiosis), and not just upon proof of complicated
pneumoconiosis. See, e.g., Penn Allegheny Coal Co. v. Mercatell, 878
F.2d 106, 109-110 (3d Cir. 1989); Wetherill v. Director, OWCP, 812 F.2d
376, 382 (7th Cir. 1987). Similarly, regarding the connection between
simple pneumoconiosis and non-respiratory deaths in particular, the
comments from Drs. Bailey and Branscomb, along with those of Dr. Fino,
focus on clinical pneumoconiosis as opposed to pneumoconiosis as more
broadly defined by the statute; thus, they do not address whether, for
instance, chronic obstructive pulmonary disease induced by coal mine
dust exposure can, in certain circumstances, contribute to a non-
respiratory death. Moreover, while Drs. Bailey and Branscomb indicate
that a causal nexus between pneumoconiosis and a non-respiratory death
would be unusual, they do not rule it out as a medical possibility. Dr.
Cohen explained how such a cause and effect relationship could occur.
Even though non-respiratory deaths hastened by pneumoconiosis may occur
relatively infrequently, the survivor should nevertheless be given the
opportunity to prove that pneumoconiosis had a tangible impact on the
miner's death in those instances. Thus, the Department believes the
``hastening death'' standard sets a reasonable benchmark for proving,
in any particular case, that pneumoconiosis contributed to the miner's
death. Of course, the burden of persuasion remains with the survivor to
prove that the miner's death was due to pneumoconiosis.
(g) One comment supports the ``hastening death'' standard.
(h) No other comments have been received concerning this section,
and no changes have been made in it.
Subpart D
20 CFR 718.301
(a) In the initial notice of proposed rulemaking, the Department
proposed deleting 20 CFR 718.301(b) (1999), which defined ``year'' for
purposes of calculating the length of a miner's coal mine employment.
62 FR 3346 (Jan. 22, 1997). The Department proposed replacing
subsection (b) and a separate provision in 20 CFR 725.493(b) (1999)
(defining ``year'' of coal mine employment for identifying responsible
operator) with a single definition of ``year'' in Sec. 725.101(a)(32).
The Department concluded that a single definition with general
applicability was appropriate since the calculation of the length of a
miner's employment is the same inquiry under both Secs. 718.301 and
725.493(b). The Department proposed no additional changes to this
regulation in the second notice of
[[Page 79952]]
proposed rulemaking. 64 FR 54971 (Oct. 8, 1999).
(b) No comments were received concerning this section, and no other
changes have been made in it.
20 CFR 718.307
(a) In the initial notice of proposed rulemaking, the Department
proposed moving the content of Sec. 718.307(a) to Sec. 725.103 to
establish a regulation of general applicability concerning burdens of
proof. 62 FR 3346 (Jan. 22, 1997). The Department also proposed
deleting Sec. 718.307(b) because it duplicated proposed Sec. 725.103.
The Department did not discuss Sec. 718.307 in its second notice of
proposed rulemaking, although the regulation remained open for public
comment. 64 FR 54971 (Oct. 8, 1999).
(b) No comments were received concerning this section. It has
therefore been removed.
20 CFR 718.401
(a) The Department proposed deleting 20 CFR 718.401 (1999) in the
initial notice of proposed rulemaking because the provision duplicated
material in proposed Secs. 725.405 and 725.406. Former Sec. 718.401
addressed each miner's statutory right to a complete pulmonary
evaluation at no expense to the miner, a right outlined in proposed
Sec. 725.406. See 30 U.S.C. 923(b). Former Sec. 718.401 also addressed
the development of additional medical evidence necessary for the
adjudication of a claim, subject matter that has been relocated to
proposed Sec. 725.405. Since both proposed Sec. 725.405 and
Sec. 725.406 are regulations with program-wide applicability, the
Department noted that no comparable regulation was necessary in part
718. 62 FR 3346 (Jan. 22, 1997). The Department proposed no additional
changes to this regulation in the second notice of proposed rulemaking.
64 FR 54971 (Oct. 8, 1999).
(b) No comments were received concerning this section. It has
therefore been removed.
20 CFR 718.402
(a) The Department proposed deleting 20 CFR 718.402 (1999) in the
initial notice of proposed rulemaking because its content duplicated
provisions of proposed Sec. 725.414, which addressed a claimant's
unreasonable refusal to cooperate in the medical development of his
claim. 62 FR 3346 (Jan. 22, 1997). The Department proposed no
additional changes to this regulation in the second notice of proposed
rulemaking. 64 FR 54971 (Oct. 8, 1999).
(b) No comments were received concerning this section. It has
therefore been removed.
20 CFR 718.403
(a) The Department proposed deleting 20 CFR 718.403 (1999) in the
initial notice of proposed rulemaking and placing its provisions in
part 725 as proposed Sec. 725.103. Section 718.403 dealt with a party's
burden of proof, and part 725 did not contain a comparable provision of
program-wide applicability. 62 FR 3346 (Jan. 22, 1997). The Department
proposed no additional changes to this regulation in the second notice
of proposed rulemaking. 64 FR 54971 (Oct. 8, 1999).
(b) No comments were received concerning this section. It has
therefore been removed.
20 CFR 718.404
(a) The Department proposed deleting 20 CFR 718.404 (1999) in the
initial notice of proposed rulemaking and placing its provisions in
part 725 as proposed Sec. 725.203(c) and (d). Former Sec. 718.404(a)
addressed a miner's obligation to inform the Department if (s)he
returns to coal mine employment; subsection (b) recognized the
Department's authority to reopen a miner's final award during his or
her lifetime and develop additional evidence if any issue arises
concerning the continuing validity of the award. 62 FR 3346 (Jan. 22,
1997). The Department proposed no additional changes to this regulation
in the second notice of proposed rulemaking. 64 FR 54971 (Oct. 8,
1999).
(b) No comments were received concerning this section. It has
therefore been removed.
Appendix B to Part 718
(a) In the initial notice of proposed rulemaking, the Department
proposed eliminating the option of taking an initial inspiration from
the open air before commencing the pulmonary function maneuver. 62 FR
3346 (Jan. 22, 1997). The Department noted that open-air inspiration
could not be recorded on the spirogram, which precluded any
confirmation by a reviewing physician that the miner had taken a full
breath. Thus, the test could yield spurious abnormal values. In the
second notice of proposed rulemaking, the Department proposed Appendix
changes to implement a requirement that physicians use the flow-volume
loop in reporting pulmonary function test results. 64 FR 54981 (Oct. 8,
1999). The Department also responded to numerous comments. Some
comments considered the requirement that the two highest FEV1 results
vary by no more than 5 percent or 100 ml to be overly restrictive, and
suggested either eliminating the requirement or liberalizing it to
allow a variability limit of 10 percent or 200 ml. The Department was
reluctant to eliminate the variation standard completely because it
provided a baseline for ensuring the validity of the test. The
Department acknowledged, however, that some individuals might be unable
to provide pulmonary function results within the 5 percent variance
standard. The Department therefore invited comment on alternative
criteria which would guarantee reproducibility of the FEV1 and FVC
values while permitting consideration of valid FEV1 results exceeding
the 5 percent standard. Other comments criticized the disability table
values as too stringent. The Department declined to consider any
changes to the tables because it did not propose revising them in the
initial notice of proposed rulemaking, and the commenters did not
provide medical support for any revisions.
(b) Three comments oppose limiting the acceptable variation between
the two largest FEV1's of the three acceptable tracings to 5 percent of
the largest FEV1 or 100 ml, whichever is greater. See Appendix
B(2)(ii)(G), of part 718. One comment urges the Department to raise the
acceptable percentage of variability from 5 percent to 10 percent. A
second comment states the 5 percent variation is too specific. This
commenter recommends the physician reporting the study be allowed to
use his judgment as to whether the test is acceptable. The third
comment, submitted by the National Institute of Occupational Safety and
Health (NIOSH), does not identify a specific percentage of increased
acceptable variability, but recommends the Department include a
provision permitting consideration of pulmonary function studies which
exceed the 5 percent limit provided the failure of the test to comply
with the standard is noted in the report. The Department agrees with
the suggested revision recommended by NIOSH, and has amended Appendix
B(2)(ii)(G) to adopt that suggestion with one addition. The Department
has added the phrase ``by the physician conducting or reviewing the
test.'' This language will ensure that a physician certifies the
results of the pulmonary function test while recognizing that it does
not meet the 5 percent variability requirement. The amended language
will provide the adjudicator with greater flexibility in determining
whether the pulmonary
[[Page 79953]]
function study actually substantiates the presence of a significant
pulmonary impairment, despite the lack of reproducible spirometric
curves within the 5 percent range.
(c) One comment recommends the Department revise the disability
tables and adopt the more liberal pulmonary function disability
criteria used by the Department of Justice for the Radiation Exposure
Compensation Program. Although the Department received comments
criticizing the table values as too stringent in response to its
initial notice of proposed rulemaking, the Department did not propose
any revisions to the tables in the second notice of proposed
rulemaking, in part, because the commenters failed to provide any
medical support for their recommendation that the tables be modified.
64 FR 54981, 55009 (Oct. 8, 1999). The Department does not consider the
present comment to provide a sufficient basis for revision of these
disability criteria. It constitutes the only comment the Department has
received which included medical evidence suggesting alternate table
values. Thus, the Department cannot determine whether the proffered
evidence represents a consensus within the medical community about
disability as measured by pulmonary function studies. The Department
does not have an adequate record upon which to formulate a judgment
about the validity of the current tables or the proposed changes. No
change in the Appendix B table values is made.
(d) No other comments have been received concerning this section,
and no other changes have been made in it.
Appendix C to Part 718
(a) The Department proposed amending Appendix C in the initial
notice of proposed rulemaking to state that arterial blood gas studies
should not be administered to a miner during, or soon after, an acute
respiratory illness. 62 FR 3346, 3381 (Jan. 22, 1997). In the preamble
to Sec. 718.105 in the second notice of proposed rulemaking, the
Department stated that one comment had noted the correct nomenclature
for partial pressure of oxygen and carbon dioxide is an upper-case
``P,'' not the lower-case ``p'' then in use. The Department changed the
references in Sec. 718.105(c)(6) in the second proposal, but neglected
to change the Appendix C table headings. Those changes have now been
made. 64 FR 54971, 54977, 55012, 55017-18 (Oct. 8, 1999).
(b) No other comments were received concerning Appendix C, and no
further changes have been made in it.
20 CFR Part 722--Criteria for Determining Whether State Workers'
Compensation Laws Provide Adequate Coverage for Pneumoconiosis and
Listing of Approved State Laws
20 CFR Part 722
(a) In its initial notice of proposed rulemaking, the Department
proposed removing many of the regulations in 20 CFR Part 722 because
they were obsolete. 62 FR 3346-47 (Jan. 22, 1997). Since 1973, Part 722
has set forth a procedure under which any state may request that the
Secretary certify that its workers' compensation laws provide
``adequate coverage'' for occupational pneumoconiosis. Such a
certification would prevent any claim for benefits arising in that
state from being adjudicated under the Black Lung Benefits Act. 30
U.S.C. 931. In addition, Part 722 has provided a set of specific
criteria that states were required to meet in order to obtain the
requested certification. Because the Part 722 regulations had not been
amended since 1973 although the statute had been amended in both 1978
and 1981, the Department proposed replacing the specific Part 722
criteria with a general statement of the statutory criteria for
certification and the statement that in the future, the Department
would review the workers' compensation laws of any state that applies
for certification in light of the then-current statutory requirements.
The Department stated that it would certify adequate coverage only if
state law guaranteed at least the same compensation, to the same
individuals, as is provided by the Act. The Department did not address
Part 722 in its second notice of proposed rulemaking. See list of
Changes in the Department's Second Proposal, 64 FR 54971 (Oct. 8,
1999).
(b) The Department has replaced a comma in the second sentence of
Sec. 722.3(a) with a semicolon to correct the punctuation of that
sentence. In addition, the Department has added the word ``relevant''
to qualify the phrase ``administrative or court decision'' in the same
sentence. This revision clarifies the Department's intent that states
submit only relevant administrative or court decisions.
(c) One comment, in the context of setting forth alternatives for
the Department to consider under the Regulatory Flexibility Act, urges
the Department to establish specific criteria the Department will use
to determine when a state black lung program provides adequate coverage
for pneumoconiosis. This revision, the commenter suggests, would allow
state legislatures to make reasoned decisions about whether to amend
their workers' compensation laws in an attempt to provide the
``adequate coverage for pneumoconiosis'' the federal statute requires.
In addition, the commenter suggests that the Department establish a
formal, ongoing review of state workers' compensation laws to determine
whether or not they provide adequate coverage.
Although no state has applied for certification in the 27 years
that the Department has administered the program, the Department
accepts the commenter's suggestion that the publication of specific
criteria would be helpful to state legislators who wish to amend their
state's laws in order to obtain Secretarial certification and thereby
preclude the application of federal law to their state's coal mine
operators. Publication of a current set of criteria, however, will
require considerable study and additional drafting, and would
needlessly delay final promulgation of the remaining regulations in the
Department's proposal. Following completion of that work, the
Department will issue a new notice of proposed rulemaking in order to
ensure that interested parties have an opportunity to comment upon
possible Secretarial certification criteria. The Department believes
that in the interim the revised Part 722 will accommodate any state
seeking certification.
The Department does not believe, however, that it would be
productive to engage in a formal, ongoing review of each state's laws
in order to determine whether they provide adequate coverage for
occupational pneumoconiosis. States that revise their workers'
compensation laws to meet the Department's criteria will do so in order
to preempt the application of the Black Lung Benefits Act. Those states
will have a clear incentive to submit an application to the Department
for the appropriate certification. Relying on states to initiate the
certification process thus makes the most efficient use of government
resources at both the state and federal levels.
(d) The Department has not received any specific comments relevant
to the individual regulations in Part 722, and no changes have been
made in them.
20 CFR Part 725--Claims for Benefits Under Part C of Title IV of
the Federal Mine Safety and Health Act, As Amended
Subpart A
20 CFR 725.1
(a) In its first notice of proposed rulemaking, the Department
proposed adding subsection (k) to Sec. 725.1 to
[[Page 79954]]
describe the incorporation into the Black Lung Benefits Act of a number
of provisions of the Social Security Act. In addition, the new
subsection noted the Department's authority to vary the application of
the incorporated provisions. 62 FR 3347 (Jan. 22, 1997). The Department
did not discuss section 725.1 in its second notice of proposed
rulemaking, see list of Changes in the Department's Second Proposal, 64
FR 54971 (Oct. 8, 1999).
(b) One comment submitted in connection with the Department's first
notice of proposed rulemaking and renewed in connection with the
Department second notice of proposed rulemaking criticizes subsections
(j) and (k) as confusing and inconsistent. The comment states that the
subsections are confusing because they do not identify the individual
instances in which the Department has altered the incorporated
provisions of the Longshore and Harbor Workers' Compensation Act
(LHWCA) and the Social Security Act (SSA). The comment also argues that
the two subsections are inconsistent because subsection (j) limits the
instances in which the BLBA departs from the LHWCA, while subsection
(k) implies other departures may be contemplated. With respect to the
first criticism, the Department believes that specific enumeration of
the departures from incorporated LHWCA provisions is unnecessary. The
objective of subsection (j) is simply to acknowledge that certain LHWCA
provisions are incorporated into the Black Lung Benefits Act (BLBA) and
that the BLBA confers specific authority on the Department to
promulgate regulations which vary the terms of these incorporated
provisions. See 30 U.S.C. Sec. 932(a). Subsection (k) fulfills the same
objective by acknowledging that there are also SSA provisions
incorporated into the BLBA. Most of those provisions were incorporated
into Part B of the BLBA, governing the adjudication of claims filed
with the Social Security Administration prior to July 1, 1973, when
Congress amended the BLBA in 1972 and 1977. See, e.g., 30 U.S.C.
922(a)(5)(1)(B), incorporating the SSA definition of the term
``disability.'' These provisions are also incorporated into Part C,
governing the adjudication of claims filed with the Labor Department,
by 30 U.S.C. 940, but only ``to the extent appropriate.'' Subsection
(k) recognizes the Department's authority to determine the extent to
which the use of these incorporated provisions is appropriate.
Furthermore, subsection (k) is consistent with subsection (j) because
it notes that the Department may resolve conflicts which arise from the
incorporation of inconsistent provisions of the two statutes. Thus, for
example, the Department may choose to depart from an incorporated LHWCA
provision (subsection (j)) because it has determined that a comparable
but inconsistent SSA provision, which is also incorporated, better
serves the interests of the program.
The Department acknowledges that, as originally proposed,
subsection (k) did not contain any reference to the SSA excess earnings
offset, 42 U.S.C. 403(b)-(1), incorporated into section 422(g). The
Department's original explanation of subsection (k), 62 FR 3385 (Jan.
22, 1997), also inadvertently omitted specific mention of section
422(g). Section 430 gives the Department the authority to determine the
extent to which application of incorporated SSA provisions into Part B
of the Act is appropriate in the context of adjudicating claims under
Part C. Section 422(g), however, provides no similar authority. It is
located in Part C of the Act, and the Department applies the
incorporated SSA offset provision as if it were a part of the BLBA. See
20 CFR 725.536 (1999). The Department has added an additional sentence
to the end of subsection (k) to describe this incorporation. In
addition, the Department has revised the first sentence of subsection
(k) to recognize that section 402 of the BLBA is contained in Part A.
The Department has also revised the fourth and seventh sentences of
subsection (k) to clarify their meaning.
(c) No other comments were received concerning this section, and no
other changes have been made in it.
20 CFR 725.2
(a) In its first notice of proposed rulemaking, the Department
proposed revising section 725.2 in order to distinguish between
revisions that would affect pending claims and revisions that would be
applied prospectively only, i.e., only to claims filed after the
effective date of the revised regulations. The Department drew a
distinction between revisions that merely clarified the Department's
interpretation of the statute and existing regulations or were
procedural regulations, and those that altered the obligations and
expectations of the parties or could not easily be applied to pending
claims. 62 FR 3347-48 (Jan. 22, 1997). The Department also explained
the legal basis for its decision to apply certain regulations
retroactively. In its second notice of proposed rulemaking, the
Department added a regulation, Sec. 725.351, to the list of revised
regulations which would apply only prospectively. 64 FR 54981-82 (Oct.
8, 1999). In addition, the Department answered several comments,
reiterating its belief that it lacked the statutory authority to make
the final rule applicable, in its entirety, to all pending claims and
rejecting the argument that the Department lacked the authority to
apply any of the regulations to pending claims.
(b) One of the comments received in connection with section 725.367
contends that the Department's regulation governing the payment of
attorneys' fees by responsible operators should not be applied
retroactively. The Department agrees; section 725.367 was inadvertently
omitted from the list of revised regulations in the Department's second
notice of proposed rulemaking that should apply only to claims filed
after the effective date of these revisions. As revised, the regulation
significantly alters the attorneys' fees that are payable by the
responsible coal mine operator. See 64 FR 54987 (Oct. 8, 1999)
(discussing the Fourth Circuit's decision in Clinchfield Coal Co. v.
Harris, 149 F.3d 407 (4th Cir. 1998)). In addition, because section
725.367 may increase the amount of attorneys' fees an operator has to
pay in a contested case, it may influence the operator's decision to
controvert the claimant's entitlement to benefits. In these
circumstances, the Department agrees that the revised version of
Sec. 725.367 should not be applied to claims filed before the effective
date of the Department's rulemaking. The Department also inadvertently
omitted Secs. 725.409, which governs denials of a claim by reason of
abandonment, 725.416, which governs informal conference proceedings,
and 725.458, which governs deposition testimony, from the list of
revised regulations that should be applied prospectively only.
Similarly, section 725.465 was not open for comment in the
Department's first notice of proposed rulemaking, 62 FR 3340-41 (Jan.
22, 1997). The Department proposed revising Sec. 725.465 in its second
notice of proposed rulemaking, 64 FR 54971, 54997 (Oct. 8, 1999), and
has revised the regulation again in the final rule. As revised,
Sec. 725.465 prohibits the dismissal of the responsible operator
finally designated by the district director from the adjudication of
claims without the consent of the Director. The revision is an integral
part of the new rules governing the identification, notification, and
adjudication of which of the miner's former employers, if any, should
be held liable for the payment of
[[Page 79955]]
his benefits (Secs. 725.407-725.408, 725.415, 725.418, 725.491-
725.495). The Department has also revised Sec. 725.421(b), which
governs the referral of a claim to the Office of Administrative Law
Judges and the evidence to be transmitted to that Office for admission
into the record at the hearing. The revisions to Sec. 725.421(b)
reflect the new rules governing the identification, notification and
adjudication of the responsible operator. Because the revisions of
those rules are prospective only, the revised version of sections
725.421(b) and 725.465 should be treated similarly. The Department has
amended subsection (c) to add Secs. 725.367, 725.409, 725.416,
725.421(b), 725.458, and 725.465 to the list of regulations which may
be applied only prospectively.
(c) A number of comments continue to insist that the Department's
regulations are impermissibly retroactive, and that the Department's
proposal violates the Supreme Court's decisions in Bowen v. Georgetown
University Hospital, 488 U.S. 204 (1988) and Eastern Enterprises v.
Apfel, 524 U.S. 498 (1998). In Bowen, the Supreme Court held that,
absent an explicit statutory grant of authority, administrative
agencies could not promulgate retroactive rules. In its first notice of
proposed rulemaking, the Department acknowledged that the Black Lung
Benefits Act did not give the Department authority to promulgate
regulations with a retroactive effect. 62 FR 3347 (Jan. 22, 1997).
Eastern Enterprises did not involve the regulatory authority of
administrative agencies; in that case, a majority of the Court held the
Congress had violated the due process clause of the Fifth Amendment to
the Constitution by improperly imposing retroactive burdens on coal
mine operators in enacting certain provisions of the Coal Industry
Retiree Health Benefit Act. For purposes of analyzing the Department's
regulations, Bowen is the more restrictive decision. Because Congress
did not grant the Department specific authority to engage in
retroactive rulemaking under the Black Lung Benefits Act, the
regulations will be permissible under Bowen only if they do not have a
true retroactive effect. Eastern Enterprises, a case in which the
retroactive effect of the legislation was clear, is inapposite to this
analysis.
The Department addressed the retroactivity issue in its earlier
notices of proposed rulemaking, 62 FR 3347-48 (Jan. 22, 1997) and 64 FR
54981-82 (Oct. 8, 1999). The Department observed that the issue of what
constitutes a retroactive effect is complex. With respect to rules that
clarify the Department's interpretation of former regulations, the
Department quoted Pope v. Shalala, 998F.2d 473 (7th Cir. 1993),
overruled on other grounds, Johnson v. Apfel, 189 F.3d 561, 563 (7th
Cir. 1999), for the proposition that an agency's rules of
clarification, in contrast to its rules of substantive law, may be
given retroactive effect. The Sixth Circuit issued a similar holding in
Orr v. Hawk, 156 F.3d 651, 654 (1994).
Underlying both the Pope and Orr decisions is the Supreme Court's
opinion in Manhattan General Equipment Co. v. Commissioner, 297 U.S.
129 (1936). Both the Sixth and Seventh Circuits quote Manhattan General
for the proposition that a rule clarifying an unsettled or confusing
area of law ``is no more retroactive in its operation than is a
judicial determination construing and applying a statute to a case in
hand.'' 297 U.S. at 135, quoted at 998 F.2d at 483; 156 F.3d at 653.
Both courts thus recognized that the Supreme Court's decision in Bowen,
which was issued in 1988, did not overrule its 1936 decision in
Manhattan General with respect to what constitutes a retroactive rule.
See First National Bank of Chicago v. Standard Bank & Trust, 172 F.3d
472, 478 (7th Cir. 1999) (stating that if the regulation at issue ``was
merely a clarification, rather than a legislative change, Bowen's ban
on retroactivity is inapplicable'').
The Department's rulemaking includes a number of such
clarifications. For example, the revised versions of Secs. 718.201
(definition of pneumoconiosis), 718.204 (criteria for establishing
total disability due to pneumoconiosis) and 718.205 (criteria for
establishing death due to pneumoconiosis) each represent a consensus of
the federal courts of appeals that have considered how to interpret
former regulations. See preamble to Secs. 718.201 (citing cases
recognizing an obstructive component to pneumoconiosis); 725.309
(citing cases recognizing the progressive nature of pneumoconiosis);
718.204; and 718.205. Moreover, none of the appellate decisions with
respect to these regulations represents a change from prior
administrative practice. Thus, a party litigating a case in which the
court applied such an interpretation would not be entitled to have the
case remanded to allow that party an opportunity to develop additional
evidence. See Betty B Coal Co. v. Director, OWCP, 194 F.3d 491, 501
(4th Cir. 1999) (``* * * we are reluctant to compel reopening as a
matter of constitutional law any time debatable questions of law are
resolved by the BRB or the courts. When such open questions are
answered, the law has been declared, not changed.''). Any party to
litigation must assume the risk that a law or regulation will be
interpreted in a manner other than that which it had hoped. The
Department's embodiment of those decisions in regulatory form should
not insulate the parties from their application to pending claims.
Similarly, the regulations in Part 725 that the Department intends
to apply to pending claims represent clarifications of unsettled or
confusing areas of the law. In particular, one commenter has objected
to the application of Secs. 725.502, 725.537, and 726.8 to pending
claims. Section 725.502 provides parties to a claim with knowledge of
when each benefit payment is due. In the first notice of proposed
rulemaking, the Department observed that the revisions are consistent
with the Department's current practice, and with appellate decisions
interpreting section 21(a) of the Longshore and Harbor Workers'
Compensation Act, 33 U.S.C. 921(a), as incorporated into the Black Lung
Benefits Act by 30 U.S.C. 932(a). 62 FR 3365 (Jan. 22, 1997). Section
725.537 codifies the Department's position, upheld in litigation, with
respect to the payment of benefits in cases in which the miner is
survived by more than one surviving spouse. The revision ensures the
proper implementation of 42 U.S.C. 416(d)(1) and (h)(1), Social
Security Act provisions that are incorporated into the Black Lung
Benefits Act by 30 U.S.C. 902(a)(2). As Pope and Orr recognize, Bowen
does not prohibit the Department from promulgating regulations to
codify its position with respect to these issues. Finally, the
Department has responded to the contention that retroactive liability
is imposed by Sec. 726.8 in the preamble to Sec. 726.8.
The same commenter has also argued that Secs. 725.542-.544,
725.547, and 725.548 should not be retroactively applied to coal mine
operators. Section 725.2, however, explicitly makes Sec. 725.547
applicable to newly filed claims only. Sections 725.542 through 725.544
are applicable to operators only by operation of section 725.547; they
are therefore also applicable only to claims filed after the effective
date of these regulations. Finally, Sec. 725.548 represents a renaming
and renumbering of a part of the former regulation at Sec. 725.547. 64
FR 55003 (Oct. 8, 1999). The Department does not believe that its
decision to rename and renumber a previous regulation should be
considered in any way retroactive.
[[Page 79956]]
By contrast, where the revision represents a clear change in the
Department's interpretation, such as the regulation governing the
payment of attorneys' fees by responsible operators, see 64 FR 54987
(Oct. 8, 1999) (discussing the Fourth Circuit's decision in Clinchfield
Coal Co. v. Harris, 149 F.3d 407 (4th Cir. 1998)), the Department has
made the change prospective only. Similarly, the revised procedures
governing the processing and adjudication of claims, sections 725.351,
725.406 through 725.418, 725.423, 725.454 through 725.459, and 725.465,
the regulations governing the identity of the responsible operator
liable for the payment of benefits, sections 725.491 through 725.495,
and the revised regulation governing operator overpayments, section
725.547, are expressly limited in their applicability to newly filed
claims. In addition, the revisions of sections 725.309 and 725.310,
governing additional claims and modification, respectively, are
prospective only. The Department has thus taken considerable care to
ensure that its revisions do not violate the Supreme Court's general
prohibition against retroactive regulations.
(c) One commenter urges that the Department's prospective revisions
not be made applicable to subsequent claims. Instead, the commenter
suggests, they should be applied only to first-time claims filed by new
claimants. The Department does not agree that a subsequent claim
differs from a first-time claim for purposes of applying the revised
regulations. In 1983, the Department considered a similar request when
it promulgated regulations to implement the Black Lung Benefits
Amendments of 1981, which transferred liability for certain claims from
coal mine operators to the Black Lung Disability Trust Fund. A number
of commenters suggested that a ``claim'' should be defined as a cause
of action, so that an individual would only ever have one ``claim'' for
benefits. The Department rejected the suggestion:
The Department believes that the claims as cause of action
analogy is misplaced. The more correct analogy would be to a
complaint or other preliminary pleading which is filed to initiate
an adjudication of the nature of the right or the validity of the
cause of action which is being asserted. Throughout its various
versions, the Act has been consistent in requiring that a claim must
be filed before any determination of eligibility for benefits could
be undertaken.
48 FR 24283 (May 31, 1983). Similarly, the Department has always
required that a subsequent claim be adjudicated according to the
standards in effect at the time the new application is filed. For
example, a miner whose 1977 claim was adjudicated and denied under the
interim presumption, 20 CFR Sec. 727.203 (1999), is not entitled to
have a 1987 claim adjudicated under the same criteria. Instead, that
claim must be adjudicated under the more restrictive Part 718 criteria.
See Peabody Coal Co. v. Spese, 117 F.3d 1001, 1007 (7th Cir. 1997). The
Department does not believe that it should alter its consistent
treatment of subsequent claims in order to exclude those claims from
consideration under the Department's revised regulations.
(d) One commenter urges the Department to alter its definition of a
``pending'' claim, which allows a claim to be considered ``pending''
for up to one year after it is denied. The commenter suggests that the
definition violates the jurisdictional rules governing finality set
forth in 33 U.S.C. Sec. 921. The Department does not agree that its
definition violates any principles of finality. Currently, a claimant
may file a request for modification at any time within one year after
the denial of a claim. 20 CFR Sec. 725.310 (1999). In fact, even a new
claim filed during the one-year period will serve to reopen the
existing claim. See Betty B Coal Co. v. Director, OWCP, 194 F3d 491,
497 (4th Cir. 1999). Consequently, an employer has no expectation that
a denied claim has been fully and completely resolved until after the
one-year period has passed.
The Department's definition of a ``pending claim'' is intended to
prevent the application of certain regulatory revisions (those which
will be applied only on a prospective basis) to any claim that was
filed before the date on which those revisions take effect. The
definition includes claims pending at various stages of adjudication
(i.e., before the district directors, the Office of Administrative Law
Judges, the Benefits Review Board, or the federal courts). In addition,
some claims that have been finally denied prior to the effective date
of the revisions can be revived by a subsequent request for
modification. For example, a claim may have been finally denied three
months before the rules became effective, and the claimant may file a
request for modification nine months later (or six months after the
revised regulations took effect). The Department does not intend that
the revised regulations that are prospective only (including, for
example, the limitation on evidence) be used to adjudicate such a
claim, and has drafted the definition of a ``pending claim'' to ensure
that result.
20 CFR 725.4
(a) In its first notice of proposed rulemaking, the Department
proposed revising subsection (d) to reflect the Department's decision
to discontinue publication of the Part 727 regulations in the Code of
Federal Regulations. 62 FR 3348 (Jan. 22, 1997). Subsection (d)
therefore referred parties interested in reviewing the Part 727
regulations to the Federal Register or the most recent version of the
Code of Federal Regulations containing the rules. The Department did
not discuss Sec. 725.4 in its second notice of proposed rulemaking. See
list of Changes in the Department's Second Proposal, 64 FR 54971 (Oct.
8, 1999).
(b) Three comments urge the Department to continue publishing the
Part 727 regulations because some claims governed by those regulations
are still in litigation. It remains the Department's position, however,
that future publication of Part 727 is unnecessary, in part because
these regulations do not apply to any claim filed after March 31, 1980.
Thus, more than twenty years have passed since claims were filed to
which these regulations apply. In addition, the Code of Federal
Regulations has printed these regulations annually for twenty years.
Consequently, access to Part 727 is readily available in the public
domain for the relatively few claims still subject to those
regulations.
(c) No other comments were received concerning this section, and no
changes have been made in it.
20 CFR 725.101
(a)(i) The Department proposed amending the definition of
``benefits'' (Sec. 725.101(a)(6)) in the initial notice of proposed
rulemaking to include the cost of the initial complete pulmonary
examination of the claimant authorized by the statute, 30 U.S.C.
923(b); Sec. 725.406, and subsidized by the Trust Fund. 62 FR 3386
(Jan. 22, 1997). Several commenters opposed the change because they
believed the revised definition would impose liability for the
examination's cost on the claimant if the claim were ultimately denied
or withdrawn. In response, the Department assured the commenters that
the cost could not be shifted to the claimant despite its
classification as a ``benefit.'' 64 FR 54982 (Oct. 8, 1999). The
Department also proposed adding a reference to augmented benefits and a
cross-reference to its definitional regulation (Sec. 725.520(c)). 64 FR
55023 (Oct. 8, 1999). The Department intended this change for the
convenience of parties looking for a comprehensive
[[Page 79957]]
definition. 64 FR 54982 (Oct. 8, 1999). (ii) Citing the Department's
representations concerning the exclusion of the complete pulmonary
examination from costs recoverable from the claimant, two comments now
support the amended definition. (iii) One comment opposes the change
because it shifts the cost of the examination to the responsible
operator if the claim is approved. The Department responded to this
argument in the second notice of proposed rulemaking by noting its
disagreement; since 1978, the regulations (20 CFR 725.406(c)) have
required the operator found liable for the claimant's benefits to
reimburse the Fund for the expenses associated with the initial
pulmonary examination. 64 FR 54982 (Oct. 8, 1999). The present comment
states the Department does not have the authority to shift the cost of
the examination, citing West Virginia University Hospitals, Inc. v.
Casey, 499 U.S. 83 (1991). At issue in Casey was the authority of a
federal court to shift liability from one party to its opponent for the
fees of experts retained to perform nontestimonial services. The
Supreme Court held the fee shifting must be limited to the specific
categories of expenses enumerated in the statute which authorized the
trial court to award fees. Because nontestimonial expert services did
not come within the ambit of any statutory category of reimbursable
expenses, the Court held the district court could not reallocate fee
liability. In so holding, the Court rejected the argument that such
expenses could be considered part of an ``attorney's fee,'' liability
for which did shift.
The Department considers Casey inapposite to the redefinition of
``benefits.'' That decision establishes only that fees for
nontestimonial expert services cannot be considered ``attorney fees''
for purposes of a statute which shifts attorney fee liability to a
prevailing party's opponent. Casey does not preclude the Department
from defining a particular nontestimonial expert service--the
Sec. 725.406 medical examination--as a ``benefit,'' liability for which
does shift to the responsible operator if the claim is ultimately
approved. (iv) The Department has the statutory authority to define
``benefits'' to include the cost of the initial medical examination,
and to require a responsible operator to pay for the examination in the
event the claim is ultimately approved. The Black Lung Benefits Act
(BLBA) incorporates section 7 of the Longshore and Harbor Workers'
Compensation Act (LHWCA). 33 U.S.C 907, as incorporated by 30 U.S.C
932(a). Section 7(e) provides:
In the event that medical questions are raised in any case, the
Secretary shall have the power to cause the employee to be examined
by a physician employed or selected by the Secretary and to obtain
from such physician a report containing his estimate of the
employee's physical impairment * * * The Secretary shall have the
power in his discretion to charge the cost of examination or review
under this subsection to the employer, if he is a self-insurer, or
to the insurance company which is carrying the risk, in appropriate
cases, or to the special fund * * *.
33 U.S.C. 907(e). Each miner's claim filed under the Black Lung
Benefits Act (BLBA) raises ``medical questions'' because the status of
the miner-claimant's pulmonary condition is the primary issue in every
claim. Section 7(e) authorizes the Department to provide each miner-
claimant with a complete pulmonary examination, and therefore address
the ``medical questions'' raised by the claim. Thus, Section 7(e)
provides the Department with the method for fulfilling its obligation
under 30 U.S.C. 923(b) to provide each miner with the opportunity to
substantiate his claim by undergoing a complete pulmonary evaluation.
Section 7(e) also authorizes the Department, at its discretion, to
charge the cost of the examination to the responsible operator. The
Department's regulations have recognized this statutory authority since
1972, when section 7 was first incorporated into the BLBA, without
regard to whether the claimant ultimately prevailed. 20 CFR 725.139, 37
FR 25466 (Nov. 30, 1972) (deputy commissioner has discretion to assess
the operator or its insurer for the cost of a physician's examination
conducted to resolve medical questions raised); 725.133 (1978) (deputy
commissioner has the authority to assess a notified operator or its
insurer for the cost of the miner-claimant's initial medical
examination). The Department promulgated its current regulation
implementing section 7(e) for BLBA purposes (20 CFR 725.406(c)) in 1978
after Congress amended section 413(b) to provide for complete pulmonary
examinations. It requires the operator adjudged liable for the
claimant's benefits to reimburse the Fund for the expenses associated
with the examination. The Department has determined that such
assessments are appropriate in those cases in which the award of
benefits for which an individual operator is liable has become final.
In the remaining cases, the Department believes the cost of the
examinations should be absorbed by the coal mining industry as a whole
by imposing the costs on the Trust Fund. 26 U.S.C. 9501(d)(1). As money
payable under section 932(a), which incorporates section 7, the
pulmonary examination cost is properly classified as a ``benefit'' and
the liable operator must reimburse the Trust Fund for such cost under
30 U.S.C. 934. The responsible operator is required to secure the
payment of benefits for which it is liable under section 932. 30 U.S.C.
933(a). The Department accordingly rejects the comment's position that
it lacks the authority to define ``benefits'' to include the cost of
the pulmonary examination required by 30 U.S.C. 923(b). (v) No other
comments were received concerning this definition, and no changes were
made in it.
(b)(i) In the initial notice of proposed rulemaking, the Department
proposed amending Sec. 725.101(a)(13), ``Coal Preparation,'' and
(a)(19), ``Miner or Coal Miner,'' to specify that coke oven workers are
excluded from coverage under the BLBA. 62 FR 3386, 3387 (Jan. 22,
1997). The Department received three comments supporting the proposed
change, which were noted in the preamble to the second proposed
rulemaking, 64 FR 54982 (Oct. 8, 1999). The Department further
clarifies the intended scope of these definitions. In the initial
notice of proposed rulemaking, the Department noted a long held
position that ``the preparation activities undertaken at coke ovens are
not covered by the BLBA.'' 62 FR 3348 (Jan. 22, 1997). The Department
now believes this language may have been too broad, and accordingly
amends the language of Sec. 725.101(a)(19) to effectuate its intention
that the definition of ``Miner'' exclude from coverage only those
workers in the coke industry who are actually employed as coke-oven
workers, i.e., those at the coke-producing ovens. See, e.g., Sexton v.
Mathews, 538 F.2d 88, 89 (4th Cir. 1975) (holding an individual who
loaded coke ovens with coal, leveled the coal inside the oven, and
shoveled finished coke for shipment, was not a ``coal miner'' under the
BLBA). The Department, however, does not intend for the identity of the
individual's employer as a coke manufacturer to be the determinative
inquiry. In some cases, coke industry employees may be otherwise
employed in activities which amount to custom coal preparation or come
within the types of activities enumerated in Sec. 725.101(a)(13). Those
workers should not be excluded from BLBA coverage solely because they
are employed by a coke producer. See Hanna v. Director,
[[Page 79958]]
OWCP, 860 F.2d 88, 92 (3d Cir. 1988) (stating: ``[T]he appropriate
characterization of [the claimant's] work for purposes of entitlement
under the Act is determined by evaluation of what he did, and not by
who employed him''). The plain language of the statutory and regulatory
definitions of ``miner'' focuses on what work the individual performed
and where (s)he performed that work, and not who employed the
individual. With respect to ``Coal preparation,'' the Department has
deleted the reference to coke oven workers because the phrase is
redundant in view of the language in ``Miner.'' (ii) No other comments
were received concerning these definitions. (iii) The Department has
changed Sec. 725.101(a)(19) by substituting the words ``coal mine
dust'' for ``coal dust.'' This change makes the regulation consistent
with the Department's long-held position that the occupational dust
exposure at issue under the BLBA is the total exposure arising from
coal mining and not only exposure to coal dust itself. The Department
previously explained this position in the second notice of proposed
rulemaking. There the Department made the same change to
Sec. 725.491(d). 64 FR 54998 (Oct. 8, 1999). A comment responding to
the initial notice of proposed rulemaking, 62 FR 3409 (Jan. 22, 1997),
had identified an inconsistency between the reference to ``coal mine
dust'' in the definition of a ``miner'' (Sec. 725.202) and the
reference to ``coal dust'' in Sec. 725.491. The Department agreed that
a consistent reference to ``coal mine dust'' should be used throughout
the regulations. ``Coal mine dust'' means any dust generated in the
course of coal mining operations, including construction. The
Department noted that this interpretation is consistent with
Congressional intent to compensate for a broad array of dust-related
lung diseases which can be linked to coal mining. 64 FR 54998 (Oct. 8,
1999). Finally, by making the change in Sec. 725.101(a)(19), the
Department expresses its disagreement with the result reached by the
Tenth Circuit in Bridger Coal Co./Pac. Minerals, Inc. v. Director, OWCP
[Harrop], 927 F.2d 1150 (10th Cir. 1991), which held that ``coal dust''
means only dust actually containing coal particulates. 927 F.2d at
1154. In the Department's view, Harrop represents too narrow a reading
of Congress' intent. See William Bros., Inc. v. Pate, 833 F.2d 261, 264
(11th Cir. 1987); Williamson Shaft Contracting Co. v. Phillips, 794
F.2d 865, 870 (3d Cir. 1986) (both cases agreeing with the Department
that ``coal mine dust'' is a permissible interpretation of BLBA).
(c) The Department proposed amending Sec. 725.101(a)(16),
``District Director,'' in the initial notice of proposed rulemaking to
substitute that title for ``Deputy Commissioner,'' and ensure that any
actions taken by a district director would be afforded the same legal
force as any action of a deputy commissioner. 62 FR 3348, 3386 (Jan.
22, 1997). No comments were received concerning this definition, and no
changes were made in it.
(d) The Department proposed amending Sec. 725.101(a)(17),
``Division or DCMWC,'' in the initial notice of proposed rulemaking to
identify the agency within the Department which contains the Office of
Workers' Compensation Programs and the Division of Coal Mine Workers'
Compensation. 62 FR 3348, 3386 (Jan. 22, 1999). No comments were
received concerning this definition, and no changes were made in it.
(e)(i) In the initial notice of proposed rulemaking, the Department
proposed amending the definition of ``workers' compensation law''
(725.101(a)(31)) to exclude certain benefits paid from a state's
general revenues. 62 FR 3387 (Jan. 22, 1997). The proposal responded to
decisions from the Benefits Review Board and Third Circuit rejecting
the Department's longstanding interpretation of the term. O'Brockta v.
Eastern Associated Coal Co., 18 Black Lung Rep.1-72, 1-79/1-80 (1994),
aff'd sub nom Director, OWCP v. Eastern Associated Coal Co., 54 F.3d
141, 148-150 (3d Cir. 1995). 62 FR 3348-49 (Jan. 22, 1997). The
Department received comments to its initial proposal opposing the
change and, in the second notice of proposed rulemaking, explained that
the Third Circuit had suggested the Department alter the regulation to
reflect accurately the Department's intended meaning. 64 FR 54982-83
(Oct. 8, 1999). (ii) Two new comments support the Department's change.
(iii) One comment opposes the amended definition because it will
adversely affect the Trust Fund financially by making certain state
benefits unavailable for offset against corresponding federal benefits.
The commenter notes the change will therefore indirectly affect the
coal producers who finance the Fund. The comment, however, overlooks
the fact that any adverse effect on operators is expected to be minimal
because of the very small number of claims which would be affected by
the exclusion of state-funded benefits. This effect is also spread
across the entire industry since the industry as a whole pays the coal
excise tax. Finally, using state benefits entirely funded by state
general revenues to offset federal benefits would confer a windfall on
responsible operators, at least in those few cases in which such state
payments may be available concurrently with a period of federal
entitlement. If such were the case, an individual operator would be
able to offset its monthly federal benefits liability by an amount of
money the state paid the claimant from its own general revenues. Thus,
the operator would profit by using state benefits which it had not paid
to reduce its federal liability. The proposed definition of ``workers'
compensation law'' eliminates this windfall. (iv) One comment opposes
the change because it codifies an alleged political agreement between
the Department and one congressman, and favors only Pennsylvania
residents. The commenter also states that the change will not affect
pending or new claims from that state, but may have unintended
consequences elsewhere. Neither point provides any basis for changing
the Department's proposal, the purpose of which is to clarify long-
standing policy. With respect to the first point, the comment fails to
consider the historical basis of the Department's policy and its
grounding in the legislative history of the BLBA. Part B of the BLBA
contains a ``maintenance of effort'' provision, 30 U.S.C. 924(d), which
states that no federal benefits shall be paid to the resident of any
State which reduces the resident's state worker's compensation benefits
because of a federal award. Both Parts B and C also each require
federal benefits to be reduced by the amount of any payments received
by a claimant under a state workers' compensation program for
disability caused by pneumoconiosis. 30 U.S.C. 922(b), 932(g). On the
eve of the BLBA's enactment in 1969, the House Managers of the bill
explained in the joint conference report: ``Benefit payments made under
State programs funded by general revenues are not included in the
maintenance of effort provision in the House amendment for the reason
that they are not to be considered workmen's compensation, unemployment
compensation, disability insurance programs as such programs are
generally understood, and as they are intended to be understood within
the context of this benefit program.'' H.R. Rep. No. 761, 91st Cong.,
1st Sess. (1969), reprinted in Senate Comm. on Labor and Public
Welfare, Legislative History of the Federal Coal Mine Health and Safety
Act of 1969, 1507, 1530 (1975). Congressman Dent of Pennsylvania
[[Page 79959]]
reinforced this understanding in his discussion of the offset
provisions and which state benefits could be used to offset the federal
benefits:
We are not talking about State programs funded through general
revenues. Any State that has such programs could reduce benefits
payable to persons eligible to receive them under this provision. If
the State did not so reduce the benefits, such benefits could not be
offset or deducted from payments under this provision.
115 Cong. Rec. 39713 (1969). No contrary expression of understanding
appears in the legislative history. Consequently, the Department fairly
understood Congressional intent to exclude state-funded disability
benefits being used to reduce federal benefits. The Third Circuit did
not invalidate the Department's policy or contradict its understanding
of Congressional intent; the Court merely held that the Department's
regulation was inconsistent with its policy, and therefore the policy
could not be sustained. As for the limited impact of proposed
Sec. 725.101(a)(31) on Pennsylvania residents, the Department
acknowledges that Pennsylvania enacted legislation in 1970 to suspend
state benefits paid from general revenues if the claimant received a
federal award. 77 P.S. 1401(k). Those benefits therefore become
unavailable for offset against federal payments in any event. The
possibility remains that Pennsylvania may change its law in the future.
Because the O'Brockta decision raises doubt concerning the Department's
interpretation of ``workers' compensation law,'' the Department
believes the regulation should be clarified to implement Congressional
intent to exclude state benefits funded by general revenues. Finally,
the potential impact of the change on states other than Pennsylvania is
speculative at best, but all states, like the public as a whole, are
entitled to a clear statement of governmental policy. In the event any
other State enacts legislation comparable to the Pennsylvania program
in the future, the legislature will have a clear understanding of the
Department's position on the meaning of ``workers' compensation law.''
(v) No other comments were received concerning this definition, and no
changes were made in it.
(f)(i) The Department initially proposed a uniform definition of
``year'' (Sec. 725.101(a)(32)) for computing the length of coal mine
employment when required in the adjudication of claims. 62 FR 3387
(Jan. 22, 1997). Under the proposed definition, a ``year'' encompassed
either a calendar year or partial periods totaling a year, during which
the miner must have received pay for work as a miner for at least 125
days; computing a year included periods when the miner received pay
while on an approved absence, e.g. vacation or sick leave. The
Department proposed that, to the extent the evidence permitted, the
beginning and ending dates of all periods of coal mine employment be
ascertained. In the event the evidence was insufficient to establish
such dates or if the miner's employment lasted less than a year, the
Department proposed a formula for computing the length of coal mine
employment based on the miner's annual earnings compared to average
wage statistics for miners compiled by the Bureau of Labor Statistics
(BLS). In response to a comment opposing the inclusion of approved
absences from work in computing the length of coal mine employment, the
Department cited judicial decisions upholding its position. 64 FR 54983
(Oct. 8, 1999). In the second notice of proposed rulemaking, the
Department altered the regulation to account for leap years by adding
``366 days'' to the definition. 64 FR 55024 (Oct. 8, 1999). The
Department now has amended the language of Sec. 725.101(a)(32) to
clarify that periods of approved absences count only towards the
miner's ``year'' of employment, and not to the actual 125 ``working
days'' during which the miner must have worked and received pay as a
miner. Thus, in order to have one year of coal mine employment, the
regulation contemplates an employment relationship totaling 365 days,
within which 125 days were spent working and being exposed to coal mine
dust, as opposed to being on vacation or sick leave. (ii) In response
to the second notice of proposed rulemaking, two comments support the
new definition because it does not afford definitive weight to Social
Security Administration records. The Department emphasized in its
second notice of proposed rulemaking that Sec. 725.101(a)(32) does not
place special weight on any particular type of evidence in determining
how long an individual worked as a coal miner. 64 FR 54983 (Oct. 8,
1999). Rather, Sec. 725.101(a)(32)(ii) recognizes that factual findings
concerning a miner's work history should be based on all of the
credible evidence available to the adjudicator. (iii) One comment
opposes the proposed formula for computing a year because it may
underestimate a miner's employment if the miner worked in a low-wage
geographic area. The commenter urges crediting a Social Security
earnings quarter of coverage as a calendar quarter of coal mine
employment, particularly for periods of coal mine employment that
occurred many years ago. Although this comment raises a legitimate
concern, no change in the regulation is necessary. The proposed formula
provides a default means of determining the length of time an
individual worked as a coal miner. This method may be used when the
beginning and ending dates of the miner's work cannot be ascertained
from the existing evidence, or the miner worked less than a year as a
miner. Moreover, the Department notes that the regulation allows a
party to introduce any relevant evidence concerning the miner's
employment. In any individual case, the miner may prove that the wages
he received were below the industry average. (iv) One comment opposes
the inclusion of non-work periods of employment when calculating a year
of employment because the miner is not exposed to any occupational
hazard during such periods. The Department disagrees, at least with
respect to determining whether the miner worked a ``year.'' Judicial
precedent has firmly established the legitimacy of counting periods of
absence from the workplace for sickness or vacations as part of the
miner's year(s) of employment. See 64 FR 54983 (Oct. 8, 1999). Despite
the lack of actual exposure to coal mine dust during these periods, the
employment relationship between the miner and his employer remains
intact. Consequently, such periods of non-exposure may be included in
the computation of the miner's work history. The Department agrees,
however, that such absences should not be included when determining
whether the miner actually worked at least 125 days during the year.
The 125-day requirement means days of actual employment as a coal
miner, and the regulation has been clarified to make the Department's
position clear. See generally Director, OWCP v. Gardner, 882 F.2d 67,
69-70 (3d Cir. 1989) (noting ``[t]he 125 day limit [in 20 CFR
725.493(b)] relates to the minimum amount of time the miner may have
been exposed to coal dust while in employment by [the] operator.'');
but see Thomas v. BethEnergy Mines, Inc., 21 Black Lung Rep. 1-10
(1997) (holding sick leave may be counted in determining whether miner
worked 125 days during year). Thus, the periods of approved absence
from the workplace may be counted only towards the miner's calendar
year of work. (v) One comment generally opposes the definition
contending it is based on outmoded concepts and
[[Page 79960]]
science. The commenter notes that miners today are exposed to less dust
as a result of more hygienic working conditions. The Department,
however, believes the definition provides a rational methodology for
determining the length of a miner's employment relationship with an
operator. The essential issues are the period(s) of time the coal mine
operator employed the miner, and the number of days during a year of
employment that the individual actually worked as a coal miner. If the
miner actually worked at least 125 days during a calendar year or
partial periods of different years totaling a 365-day period, then the
miner has worked one year for purposes of the program regulations.
Whether the miner was exposed to reduced levels of coal mine dust
during the working days is irrelevant to this computation. Rather, such
evidence may be relevant to an operator's attempt to rebut the
presumption of regular and continuous exposure to coal mine dust found
in Sec. 725.491(d). With respect to the 125-working day issue, the
Department notes its disagreement with Landes v. Director, OWCP, 997
F.2d 1192, 1197-98 (7th Cir. 1993), and Yauk v. Director, OWCP, 912
F.2d 192, 195 (8th Cir. 1989) (both cases decided under 20 CFR
718.301(b)). In both cases, the court held that a miner should receive
credit for a full year of employment for each partial period of each
calendar year during which the miner worked at least 125 days. The
Department believes the partial periods must be aggregated until they
amount to one year of coal mine employment comprising a 365-day period.
Only then should the factfinder determine whether the miner spent at
least 125 working days as a coal miner during the year. See Croucher v.
Director, OWCP, 20 Black Lung Rep. 1-67 (1996) (holding ``year'' means
calendar year or partial periods totaling calendar year; opposing party
may establish irregular employment by showing miner worked fewer than
125 days during year). Consequently, no basis has been provided for
abandoning the proposed definition of a ``year.'' (vi) No other
comments were received concerning this definition, and no changes were
made in it.
20 CFR 725.103
(a) In the initial notice of proposed rulemaking, the Department
proposed Sec. 725.103 as a regulation of general applicability to
delineate the general burdens of proof for the parties to a claim. 62
FR 3388 (Jan. 22, 1997). The comments opposing this regulation
challenged the Department's authority to adjust the burdens of proof
among the parties. The Department responded with a detailed analysis of
the relevant precedent and its own authority. 64 FR 54972-74 (Oct. 8,
1999). For a number of reasons, the Department concluded that the
Administrative Procedure Act (APA), 5 U.S.C. 556(d), does not preclude
it from incorporating presumptions into the regulations which
reallocate the burden of proving certain facts. First, the statute
itself places limitations on the operation of the APA while conferring
on the Secretary broad regulatory authority. The Federal Mine Safety
and Health Act (FMSHA), which includes the Black Lung Benefits Act
(BLBA) as title IV, generally exempts its provisions from the APA. 30
U.S.C. 956. The BLBA, however, incorporates section 19 of the Longshore
and Harbor Workers' Compensation Act (LHWCA), 33 U.S.C. 919(d), thereby
making the APA applicable to the adjudication of claims. The
incorporation of the APA is subject to one important constraint:
Congress conferred on the Secretary the authority to vary the terms of
the incorporated provisions by regulation. 30 U.S.C. 932(a) (provisions
of LHWCA apply to BLBA ``except as otherwise provided * * * by
regulations of the Secretary''). See generally Director, OWCP v.
National Mines Corp., 554 F.2d 1267, 1273-74 (4th Cir. 1977); Patton v.
Director, OWCP, 763 F.2d 553, 559-60 (3d Cir. 1985). Second, the
Department noted that the Supreme Court's decision in Director, OWCP v.
Greenwich Collieries, 512 U.S. 267 (1994), did not address, much less
restrict, the Department's statutory authority to alter the
applicability of the APA. In Greenwich Collieries, the Supreme Court
addressed only whether the Department had promulgated a regulatory
presumption (20 CFR 718.3) that required a finding for the claimant if
the evidence for and against a claimant on a particular issue was
evenly balanced. The Court considered Sec. 718.3(c) too ambiguous to
operate as an exception to the APA's requirement that the party who
bears the burden of persuasion must prevail by a preponderance of the
evidence. Because the Court's interpretation of the regulation resolved
the issue, the Court did not reach the Department's argument that it
has statutory authority to override 5 U.S.C. 556(d) by regulation and
shift the burden of persuasion as well. Furthermore, the Court did not
decide which party bears the burden of persuasion; rather, it
determined only what standard of proof must be met by the party bearing
the burden of persuasion. The Department therefore concluded Greenwich
Collieries does not prohibit the Department from assigning burdens of
proof to parties other than the claimant if necessary to achieve the
goals of the BLBA. 64 FR 54973 (Oct. 8, 1999). Finally, the Department
surveyed other decisions which upheld the authority of an agency to
allocate the burden of persuasion by means of factual presumptions.
This caselaw lent additional support for the Department's conclusion
that its general rulemaking authority permitted it to adjust the
burdens of proof among the parties, provided a rational basis existed
between the proven facts and those presumed.
(b) One comment contends the Department has no authority under the
APA to allocate burdens of proof in a proceeding before an
administrative law judge (ALJ). The comment cites no authority,
statutory or otherwise, for this proposition. For purposes of
responding to the comment, the Department assumes the reference to ALJ
proceedings means a reference to a proceeding governed by the APA,
including 5 U.S.C. 556(d) (allocating burden of persuasion to proponent
of a rule or order). In the second notice of proposed rulemaking, the
Department examined the statutory authority which permits it to vary
the terms of the APA by regulation. 64 FR 54973 (Oct. 8, 1999). The
comment provides no refutation of the conclusions drawn from this
analysis. Because the Department has already responded to the substance
of the comment's objection, no further response is warranted.
(c) One comment suggests the Supreme Court's decision in Allentown
Mack Sales & Service, Inc. v. NLRB, 522 U.S. 359 (1998), prohibits the
Department from reallocating burdens of proof absent statutory
authority. As an initial matter, the Department addressed this decision
in its second notice of proposed rulemaking. 64 FR 54973 (Oct. 8,
1999). The Department quoted dicta from the majority opinion which
explicitly supports the authority of an agency to promulgate
``counterfactual evidentiary presumptions * * * as a way of furthering
legal or policy goals[.]'' 522 U.S. at 378. The comment does not
respond to this analysis, or explain in what manner the Department has
erroneously interpreted the decision. In any event, the Department
believes Allentown Mack provides no precedential basis for limiting the
Department's authority to assign burdens of production and persuasion
to parties other than the claimant. That case involved a dispute over
the evidentiary showing a company must
[[Page 79961]]
make to deny recognition to an incumbent union. According to NLRB case
law, the company must establish a ``reasonable doubt'' that the union
enjoys the majority support of its members. The NLRB held that
Allentown Mack had not established the existence of such doubt by a
preponderance of the evidence. The Supreme Court ultimately overturned
the Board's factual findings because the Court concluded the Board had
applied in actuality a higher burden of proof than it had announced in
its decisions. 522 U.S. at 378-80. Although the comment depicts this
decision as an extension of Greenwich Collieries, Allentown Mack has no
bearing on an agency's authority to vary the terms of the APA or
reallocate the burden of persuasion to a party other than the proponent
of a rule or order. Allentown Mack establishes only the proposition
that an agency cannot announce one standard of proof in principle and
apply a higher standard of proof in practice. The Department therefore
rejects the comment's position.
(d) No other comments were received concerning this definition, and
no changes were made in it.
Subpart B
20 CFR 725.202
(a) The Department proposed changing the definition of ``miner'' in
the initial notice of proposed rulemaking. 62 FR 3388-89 (Jan. 22,
1997). Specifically, the Department proposed creating a rebuttable
presumption that any individual working in or around a coal mine or
coal preparation facility was a ``miner'' within the meaning of the
Black Lung Benefits Act (BLBA). The party liable for benefits could
rebut the presumption by proving the individual did not perform coal
extraction, preparation or transportation work while at the mine site,
or did not engage in mine maintenance or construction. The presumption
could also be rebutted by demonstrating that the individual was not
regularly employed around a coal mine or coal preparation facility. The
Department also proposed restructuring the existing regulation (20 CFR
725.202) to differentiate special provisions applicable only to
transportation and construction workers. See generally 64 FR 3349 (Jan.
22, 1997). The Department did not propose any further changes to this
regulation in the second notice of proposed rulemaking. 64 FR 54971
(Oct. 8, 1999).
(b) Two comments generally object to the revised definition of
``miner,'' arguing that it forces operators to defend against claims
from employees only peripherally involved in the coal mining process.
The revisions primarily rearrange the component parts of 20 CFR
725.202(a), and segregate special provisions involving construction and
transportation workers. The regulation does include a rebuttable
presumption that any on-site worker at a coal mine or coal preparation
facility is a ``miner.'' This presumption reflects the rational
assumption that an individual working in or around a coal mine is
involved in the extraction, preparation or transportation of coal, or
in the construction of a mine site; these functions are enumerated by
the statutory definition of a ``miner.'' The operator may rebut the
presumption by disproving either the required nexus between the
worker's duties and coal mining, or any regular employment at a coal
mine facility. This burden is not onerous given the operator's access
to information about the use and duties of the workers at its
facilities.
(c) One comment objects to coverage for coal mine construction
workers whose jobs are integral to the construction of a coal mine site
or facility. The commenter argues that coverage should include only
those construction workers whose jobs are integral to the extraction or
preparation of coal, citing William Bros., Inc. v. Pate, 833 F.2d 261
(11th Cir. 1987), and Bridger Coal Co./Pac. Minerals, Inc. v. Director,
OWCP [Harrop], 927 F.2d 1150 (10th Cir. 1991), and only if those
individuals are also exposed to coal dust as a result of their work.
The Department, however, believes the focus on mine construction,
rather than coal extraction or preparation, is consistent with
Congressional intent in extending coverage to construction workers. The
Fourth Circuit has identified the flaw in using the traditional
``situs/function'' test for coal mine construction workers: ``Coal mine
construction * * * involves neither the extraction nor preparation of
coal. If, therefore, we apply the two-step test to coal mine
construction workers, they would rarely, if ever, qualify as miners
under the Act.'' The Glem Co. v. McKinney, 33 F.3d 340, 342 (4th Cir.
1994). The logical inquiry concerning the construction workers'
activities must therefore look to coal mine construction, which
inevitably (and generally) involves the pre-extraction work of building
the mine facility itself. That such work is consistent with work at a
coal mine is evident from the statutory definition of ``coal mine:''
``an area of land and all structures, facilities, * * * shafts, slopes,
tunnels * * * and other property, real or personal, * * * used in, or
to be used in, the work of extracting'' coal. 30 U.S.C. 802(h)(2)
(emphasis supplied); see also 20 CFR 725.101(a)(23) (renumbered as
Sec. 725.101(a)(12)). A construction worker who builds the ``coal
mine'' is a ``miner'' to the extent work at the covered site exposes
him or her to ``coal mine dust.'' Moreover, the fact that the claimant
worked at non-operational mines is not, by itself, sufficient to
establish a lack of coal mine dust exposure. The construction process
itself may expose the miner to coal mine dust. In addition, a coal mine
construction worker exposed to coal mine dust from an operating coal
mine in the vicinity of the construction site is a ``miner'' under the
Black Lung Benefits Act (BLBA). R&H Steel Buildings v. Director, OWCP,
146 F.3d 514, 516-17 (7th Cir. 1998).
Pate and Harrop, cited by the commenter, do not provide compelling
authority to depart from the proposed regulation. In Pate, the Court
stated that ``construction workers are covered only if they have been
exposed to dust arising from the extraction or preparation of coal.''
833 F.2d at 266 (footnote omitted). Limiting covered construction
activities to work involving dust exposure from coal extraction and
preparation, however, incorrectly combines two independent elements of
the definition of ``miner'': the ``function'' requirement for
qualifying as a miner under the BLBA, i.e., working in the extraction
or preparation or transportation of coal or in coal mine construction,
and the exposure requirement for a construction worker. The two are
unrelated. The only plausible explanation for separately including
construction workers in the statutory definition of ``miner'' is
Congress' recognition of their unique functional status. Construction
workers generally perform their work before a mine becomes operational.
Consequently, they generally will not be involved in the extraction or
preparation of coal, or exposed to dust from such activities. While
rejecting this position, the Court did acknowledge the Department's
authority to implement its views through regulation: ``If the Secretary
has a position he wishes to express, he can do it through the proper
forum, i.e., the implementation of new, clarifying regulations.'' 833
F.2d at 265. Section 725.202 represents the exercise of that authority.
In Harrop, the Court held that the exposure to ``coal mine dust,''
required by 20 CFR 725.202(a) for coverage of a construction worker,
involves exposure to ``dust containing coal.'' 927 F.2d at 1154, citing
Pate. It interpreted the
[[Page 79962]]
statutory coverage of construction workers to reach only those
individuals who are exposed to actual coal dust, despite acknowledging
the variety of other (non-coal) dusts which may be inhaled at a mine
construction site. The Department has consistently taken the position
that ``coal mine dust'' means any dust generated at a coal mine site,
and that exposure to coal mine dust is sufficient to meet the statutory
definition of ``miner''for construction workers. 20 CFR 725.202(a); see
generally Williamson Shaft Contracting Co. v. Phillips, 794 F.2d 865,
869 (3d Cir. 1986) (upholding validity of 20 CFR 725.202(a) because
Congress understood ``coal dust'' to mean ``the various dusts around a
coal mine''). The interpretation of coverage reached by the Court in
Harrop would effectively exclude most, if not all, construction workers
from the definition of ``miner'' after Congress explicitly changed the
definition to include them. The Department declines to adopt the more
restrictive standard suggested by the Tenth Circuit and the commenter.
(d) One comment objects to the application to construction workers
of the rebuttable presumption that any on-site worker is a ``miner.''
For the reasons expressed in paragraph (b), the Department believes any
individual whose employment requires him or her to perform work at a
coal mine can logically be presumed to be involved in a covered coal
mine function. The commenter has provided no reason to exclude
construction workers from that presumption, and the Department declines
to do so.
(e) One comment received after publication of the initial notice of
proposed rulemaking and referenced again after publication of the
second notice objects to subsection (d), which describes the elements
of entitlement for a miner and references the specific regulatory
criteria in Part 718 for establishing those elements. The comment links
its objection to criticisms of the specific Part 718 regulations rather
than any aspect of subsection (d). The Department's responses to those
criticisms are discussed under the particular Part 718 sections. No
further response in the context of this regulation is necessary.
(f) Two comments support the revised section 725.202.
(g) No other comments concerning this section have been received,
and no changes have been made in it.
20 CFR 725.203
(a)(i) The Department proposed changing Sec. 725.203 in the initial
notice of proposed rulemaking to eliminate the filing of a claim as an
element of entitlement for a miner. 62 FR 3389 (Jan. 22, 1997). This
change clarified that a miner is entitled to benefits for all periods
of compensable disability, including any period which occurred prior to
the filing of the claim. 62 FR 3349 (Jan. 22, 1997). The Department
also incorporated into Sec. 725.203 provisions from 20 CFR 718.404,
which was deleted. These provisions require an entitled miner to notify
the Department if (s)he returns to coal mining or comparable work, and
authorize the Department to reopen a final miner's award in appropriate
circumstances for the development of additional evidence and the
reevaluation of entitlement. 62 FR 3349, 3389 (Jan. 22, 1997). Finally,
Sec. 725.203(b)(2) now refers to Sec. 725.504, which is the renumbered
version of Sec. 725.503A. 62 FR 3341 (Jan. 22, 1997). The Department
proposed no further changes to Sec. 725.203 in the second notice of
proposed rulemaking. 64 FR 54971 (Oct. 8, 1999). (ii) The Department
has now further amended Sec. 725.203(d), however, to restore language
requiring the beneficiary to submit ``medical reports and other
evidence'' if the Office determines the evidence is necessary to
resolve any question concerning the validity of the award. This phrase
appears in 20 CFR 718.404(b), and was inadvertently omitted in the
earlier proposal to change Sec. 725.203. The Benefits Review Board has
since interpreted the phrase in Sec. 718.404(b) to involve discovery
requests. Stiltner v. Westmoreland Coal Co., Black Lung Rep., BRB No.
98-0337, slip op. at 5 (Jan. 31, 2000) (en banc). The Department did
not intend the changes to Sec. 725.203(d) to foreclose evidentiary
development other than medical examinations of the miner. The
Department therefore adds the language formerly in Sec. 718.404(b) to
Sec. 725.203(d), and clarifies its intent that the miner may be
required to submit to medical examinations, produce medical evidence
and answer discovery requests when the circumstances raise any issue
concerning the validity of the award after the award becomes final.
(b)(i) One comment suggests the revision of subsection (a)
improperly extends the eligibility period. The Department rejects this
interpretation. The change merely harmonizes that provision with
Sec. 725.503, and ensures the miner's entitlement to benefits for any
period of eligibility which predates the filing of a claim. See 62 FR
3349 (Jan. 22, 1997). (ii) Two comments approve of the change to
subsection (a).
(c) Three comments oppose subsection (d) because it permits the
Department to reopen an approved claim if issues arise concerning its
validity. Subsection (d) simply recognizes the Department's authority
to investigate any finally approved miner's claim if circumstances
raise an issue pertaining to the validity of the award. Such authority
is necessary in order to monitor a miner's continuing eligibility and
prevent the payment of benefits to any claimant whose eligibility
ceases. The Department rejects the suggestion that this authority
should be limited to cases involving fraud or the miner's return to
coal mining. Limiting the reopening authority under subsection (d) in
this manner would be inconsistent with the Department's statutory
authority to modify an award based on a factual mistake or change in
condition at any time within one year after the last payment of
benefits. 33 U.S.C. 922, as incorporated by 30 U.S.C. 932(a); 20 CFR
725.310. Furthermore, such a limitation would impinge on the right of
responsible operator to petition for modification and request a medical
examination if circumstances call into question the entitlement of the
miner. The Department emphasizes that the responsible operator does not
have an absolute right to compel the claimant to submit to a medical
examination for purposes of the modification petition. Selak v. Wyoming
Pocahantas Land Company, 21 Black Lung Rep. 1-173, 1-178 (1999); see
also Stiltner v. Westmoreland Coal Co., Black Lung Rep., BRB No. 98-
0337, slip op. at 5 (Jan. 31, 2000) (en banc) (holding operator does
not have absolute right to compel claimant to respond to discovery
request under 20 CFR 718.404(b) in connection with modification
petition). Upon production of reasonable evidence justifying the
request, however, the district director (or administrative law judge)
may order the claimant to submit to a medical examination. Selak, 21
Black Lung Rep. at 1-179.
(d) One comment urges the Department to limit its authority to
reopen awards under subsection (d) to the first year after the award
becomes final. Such a limitation, however, is inconsistent with the
Department's statutory authority to modify. 33 U.S.C. 922, as
incorporated. In the case of an award, that authority extends to ``one
year after the date of the last payment of compensation.'' Furthermore,
the limitation would also adversely affect the responsible operator's
right to request modification if it became aware of circumstances which
call into question the validity of the award. See response to comments
(c).
[[Page 79963]]
(e) In response to the initial notice of proposed rulemaking, one
comment opposed subsection (d) because the provision did not expressly
acknowledge that a claim may be reopened if the miner's condition
improved. The Department previously rejected a similar suggestion when
it promulgated the final version of 20 CFR 718.404 in 1980. The
Department initially proposed Sec. 718.404 with a requirement that an
entitled individual contact the Office of Workers' Compensation
Programs if ``[h]is or her respiratory or pulmonary condition
improves[.]'' 43 FR 17727 (Apr. 25, 1978). The requirement was deleted
in the final version ``in response to comments and testimony stating
that pneumoconiosis does not, in fact, improve.'' 45 FR 13694 (Feb. 29,
1980). The same commenter submitted an additional response to the
second notice of proposed rulemaking, and now approves of subsection
(d) because it does not preclude the right of a liable party to
challenge a final award at a later date. The Department therefore
declines to incorporate any language affirmatively citing improvement
in a miner's health as grounds for reopening an award.
(f) No other comments were received concerning this section, and no
changes have been made in it.
20 CFR 725.204
(a) The Department proposed amending Sec. 725.204 in the initial
notice of proposed rulemaking to conform the regulatory criteria for
marital relationships to intervening changes in the law since the
regulation was issued in 1978. 62 FR 3349-50 (Jan. 22, 1997). The
Department provided a detailed statutory analysis in the initial
notice. To summarize: the Black Lung Benefits Act (BLBA) incorporates
the definition of a dependent ``wife'' used by the Social Security Act
(SSA), 42 U.S.C. 416(h)(1), as incorporated by 30 U.S.C. 902(a)(2),
(e). The SSA recognizes both ``legal'' and ``deemed'' spouses; the
latter is an individual who married the wage earner while ignorant that
some legal impediment existed to deny validity to the marriage. Before
1990, Sec. 416(h) contained a provision preventing a ``deemed spouse''
from receiving benefits if a ``legal'' spouse existed and was receiving
benefits on the wage earner's account. 42 U.S.C. 416(h)(1)(B). The
Department included this limitation in the dependency criteria when it
promulgated Sec. 725.204. 20 CFR 725.204(d)(1). In 1990, Congress
amended the SSA to remove the prohibition on ``deemed spouse''
entitlement if a legal spouse existed and was receiving benefits. 104
Stat. 1388-278 to 1388-280 (1990). Legislative history clearly
established Congressional intent to permit both the ``deemed'' spouse
and the legal spouse to receive concurrent benefits. See H.R. Rep. No.
101-964, 1990 U.S.C.C. & A.N. 2649, 2650 (conference report).
Accordingly, the Department proposed similar changes to Sec. 725.204 to
delete the regulatory bar to ``deemed'' spouse entitlement under the
BLBA. The Department proposed no additional changes to this regulation
in its second notice of proposed rulemaking. 64 FR 54971 (Oct. 8,
1999).
(b) Two comments approve of the change to this section
acknowledging the eligibility of a spouse to receive benefits despite
the existence of a legal impediment to the validity of the marriage to
the miner unless the individual entered into the marriage with
knowledge it was not valid.
(c) No other comments concerning this section were received, and no
changes have been made in it.
20 CFR 725.209
(a) In the initial notice of proposed rulemaking, the Department
erroneously proposed changing Sec. 725.209(a)(2)(ii) to state that, in
order to be considered a dependent, a child who is at least 18 and not
a student must be under a disability that commenced before the age of
22. 62 FR 3390 (Jan. 22, 1997). The purpose of the change was to
reflect in the regulation itself the age by which certain children's
disabilities must commence, a requirement imposed by an incorporated
provision of the Social Security Act. 42 U.S.C. 402(d)(1)(B)(ii), as
incorporated into the BLBA by 30 U.S.C. 902(g). 62 FR 3350 (Jan. 22,
1997). After further consideration, however, the Department reproposed
the regulation without the new language. 64 FR 55026 (Oct. 8, 1999).
Eliminating the age by which the disability must have begun for a
dependent child harmonizes Sec. 725.209 with the statutory definition
by preserving the distinction between a child/augmentee and a child/
beneficiary (see Sec. 725.221). A child who claims benefits in his or
her own right based on personal disability (child/beneficiary) must
prove the disability arose before age 22 as required by 30 U.S.C.
902(g). 30 U.S.C. 922(a)(3). A dependent child who is an augmentee of a
beneficiary, however, is exempt from this requirement because the
statutory definition of ``dependent'' explicitly exempts a ``child''
from the requirement that disability begin by a certain age. 30 U.S.C.
902(a)(1). See generally 64 FR 54983 (Oct. 8, 1999).
(b) Reference should be made to the Department's response to
comments concerning Sec. 725.219 to determine the effect of marriage on
a child's dependency status under Sec. 725.209(a)(1).
(c) No comments concerning changes to this section were received in
response to either the initial notice of proposed rulemaking or the
second notice of proposed rulemaking, and no further changes have been
made in it.
20 CFR 725.212
(a) In the initial notice of proposed rulemaking, the Department
proposed amending Sec. 725.212 to codify the right of each surviving
spouse of a deceased miner to receive a full monthly benefit without
regard to the existence of any other entitled surviving spouse. 62 FR
3390 (Jan. 22, 1997). The Department concluded that both statutory
analysis and Congress' intent compelled this result, and explained at
length the reasoning behind the conclusion. 62 FR 3350-51 (Jan. 22,
1997). See also Sec. 725.537, and response to comments. The Department
proposed no further changes to this regulation in its second notice of
proposed rulemaking. 64 FR 54971 (Oct. 8, 1999).
(b) Five comments object to subsection (b) because it permits each
surviving spouse of a deceased miner to receive full monthly benefits
if (s)he establishes eligibility regardless of the existence of any
other entitled surviving spouse. The commenters assert that the change
will increase the cost of paying survivors' benefits. Increased costs
alone do not justify denying eligible individuals the benefits to which
they are entitled by law.
(c) Two comments argue the change is not permitted by the relevant
statutes; one comment disputes the Department's conclusion that its
earlier procedure was adopted in error, citing undocumented
representations by the Social Security Administration (SSA) to the
Department in 1978. In the initial notice of proposed rulemaking, the
Department provided a detailed legal analysis of the pertinent
statutory authorities and legislative history, all of which support
awarding full monthly benefits to more than one surviving spouse. See
62 FR 3350-51 (Jan. 22, 1997). Congress amended the Social Security Act
in 1965 to allow benefits to a divorced surviving spouse as a ``widow''
of the miner. Pub. L. No. 89-97, Sec. 308(b)(1), 79 Stat. 286 (1965).
The legislative history of the amendment clearly established Congress'
intent that payment of benefits to two (or more) ``widows'' would not
reduce the benefits paid to either of the widows. S.
[[Page 79964]]
Rep. No. 404, 89th Cong., 1st Sess. (1965), reprinted in 1965 U.S.C.C.
& A.N. 1943, 2047. In 1972, Congress amended the BLBA definition of
``widow'' to adopt the Social Security Act definition. 30 U.S.C.
902(e). The legislative history is equally clear that Congress intended
to conform the BLBA definition to the Social Security Act definition.
S. Rep. No. 743, 92nd Cong., 2d. Sess., reprinted in 1972 U.S.C.C. &
A.N. 2305, 2332. The BLBA also reinforces this interpretation because
it requires a ``widow'' to receive benefits at prescribed rates and
makes no allowance for a reduction based on the existence of more than
one widow. 30 U.S.C. 922(a)(2). To date, two courts of appeals and the
Benefits Review Board have accepted the Department's position. Peabody
Coal Co. v. Director, OWCP [Ricker], 182 F.3d 637, 642 (8th Cir. 1999);
Mays et al. v. Piney Mountain Coal Co., 21 Black Lung Rep. 1-59, 1-65/
1-66 (1997), aff'd 176 F.3d 753, 764-765 (4th Cir. 1999). No court has
reached a contrary result, and no comment has addressed the substance
of this analysis. Consequently, the Department has no basis for
changing the regulation. Finally, the Department cannot respond to the
alleged communication between SSA and the Department because the
comment provides no detailed evidence as to the nature or content of
the communication. In any event, an undocumented assertion concerning
another agency's intention cannot form the basis for displacing a
proper interpretation of the pertinent statutes, especially when courts
have unanimously upheld that interpretation.
(d) One comment states that the SSA regulations implementing part B
of the BLBA do not permit more than one surviving spouse to receive
full benefits. SSA's program regulations (20 CFR part 410) are silent
on the entitlement of multiple surviving spouses. In any event, the
Department has independent authority to issue regulations for part C of
the BLBA, 30 U.S.C. 936(a), and Sec. 725.212 is consistent with the
applicable provisions of the BLBA and the SSA as incorporated.
(e) One comment states that the current Coal Mine (BLBA) Procedure
Manual is consistent with the position that full monthly benefits
cannot be paid to each surviving spouse when more than one spouse
qualifies for one deceased miner. This statement is simply erroneous.
Since at least 1994, the Procedure Manual has unequivocally provided
that ``[w]hen a surviving spouse and a surviving divorced spouse both
qualify as primary beneficiaries, each is entitled to full basic
benefits plus full augmentation.'' Coal Mine (BLBA) Procedure Manual,
ch. 2-900, para. 8.f (Sept. 1994).
(f) One comment contends the Department lacks the authority to
require an operator to pay the same benefit twice. The Department
rejects this contention. As discussed above, the BLBA unequivocally
requires the payment of full monthly benefits to each surviving spouse
who fulfills the eligibility criteria. The statute does not recognize
any limitation on the liability for these benefits, or any reduction in
the amount to which the eligible surviving spouse is entitled.
(g) Two comments support the change in subsection (b).
(h) No other comments were received concerning this section, and no
changes have been made in it.
20 CFR 725.213
(a) The Department proposed amending Sec. 725.213 in the initial
notice of proposed rulemaking to harmonize that regulation with changes
to Sec. 725.204, which now recognizes the independent eligibility of a
``deemed'' spouse to receive benefits notwithstanding the existence of
a legal spouse who is also receiving benefits. 62 FR 3351 (Jan. 22,
1997) The Department also proposed adding paragraph (c) to codify the
right of a surviving beneficiary, who loses eligibility through some
legal impediment, to resume eligibility upon the cessation of that
impediment. The Department did not propose any further changes to the
regulation in its second notice of proposed rulemaking. 64 FR 54971
(Oct. 8, 1999).
(b) Two comments object to reentitlement for a surviving spouse who
loses eligibility, but later reestablishes all the requirements. The
commenter states in general terms that the provision is contrary to the
Social Security Act (SSA), represents an unwarranted increase in
benefits liability, and should be abandoned. The commenter cites no
specific authority for its argument. The legislative history of 30
U.S.C. 902(e), the statutory definition of ``widow'' which Sec. 725.213
implements, establishes congressional intent to afford a miner's widow
the same right to resumption of black lung benefits upon termination of
a remarriage as exists for a widow receiving SSA benefits.
The Black Lung Benefits Act (BLBA), as enacted in 1969, defined
``widow'' to mean
the wife living with or dependent for support on the decedent at the
time of his death, or living apart for reasonable cause or because
of his desertion, who has not remarried.
Pub. L. 91-173, Sec. 402(e), 83 Stat. 793 (1969) (emphasis supplied).
The emphasized language excluded from coverage any miner's survivor who
later remarried, without regard to the subsequent termination of the
marriage. In 1972, Congress amended the definition of `widow' by
enacting the current version. In pertinent part, the phrase ``who is
not married'' replaced ``who has not remarried.'' The Senate report
accompanying the proposed amendments states that ``[t]he term `widow'
in Sec. 402(e) is likewise redefined to conform to the Social Security
Act definition.'' S. Rep. No. 743, 92nd Cong., 2d. Sess. 30, reprinted
in 2 Comm. On Labor and Pub. Welfare, 94th Cong., 1st Sess.,
Legislative History of the Federal Coal Mine Health and Safety Act of
1969, at 1974 (1975). The legislative history therefore unequivocally
establishes congressional intent to define ``widow'' for purposes of
the Black Lung Benefits Act and SSA in the same manner.
At the time of the 1972 amendments to the BLBA, the SSA defined a
``widow'' as an individual who ``is not married.'' 42 U.S.C.
403(e)(1)(A). Congress had previously amended the SSA definition in
1965 by replacing the phrase ``has not remarried'' with ``is not
married.'' Pub. L. 89-97, Sec. 308(b)(1), 79 Stat. 286, 376 (1965). The
legislative history of the amendment indicates that Congress intended
an aged divorced wife, widow or surviving divorced wife, who was not
married at the age of eligibility, to retain ``whatever rights to
benefits she has ever had, regardless of intervening marriages, which
have ended in death, divorce or annulment.'' S. Rep. No. 404, 89th
Cong., 1st Sess., reprinted in 1965 U.S.C.C. & A.N. 1943, 2048. The
legislative history therefore underscores the congressional intention
to permit restoration of SSA eligibility to a widow whose intervening
marriage has terminated. The Social Security Administration regulations
implementing Part B of the BLBA confirm this view:
An individual is entitled to benefits as a widow, or as a
surviving divorced wife, for each month beginning with the first
month in which all of the conditions of entitlement * * * are
satisfied. If such individual remarries, payment of benefits ends
with the month before the month of remarriage * * *. Should the
remarriage subsequently end, payment of benefits may be resumed * *
*.
20 CFR 410.211(a). The Sixth Circuit and the Benefits Review Board have
also adopted the Department's position, and no circuit has taken a
contrary view. Wolf Creek Collieries v. Robinson, 872 F.2d 1264, 1266
(6th Cir. 1989); Luchino v. Director, OWCP, 8 Black Lung Rep. 1-
[[Page 79965]]
453, 1-456 (1986). The commenter's objection must be rejected.
In promulgating Sec. 725.213, the Department recognizes that
permitting reentitlement of surviving spouses and children
(Sec. 725.219) treats these classes of beneficiaries more generously
than surviving brothers and sisters of the deceased miner
(Sec. 725.223). One comment notes it is appropriate to end benefit
entitlement permanently when a brother or sister marries, and implies
the same treatment should be accorded all other classes of
beneficiaries and augmentees, including surviving spouses and children.
The Department believes the difference in treatment is required by the
BLBA. Section 412(a)(5) states that ``[n]o benefits to a sister or
brother shall be payable under this paragraph for any month beginning
with the month in which he or she * * * marries.'' 30 U.S.C. 922(a)(5).
This provision terminates eligibility if a miner's brother or sister
who is receiving benefits marries. Unlike the statutory definitions of
``widow'' and ``child,'' 30 U.S.C. 902(e), (g), section 412(a)(5)
focuses on the occurrence of an event when ineligibility commences
rather than the individual's status. The widow's or child's marriage
status can change over time; once the event of marriage occurs for a
brother or sister, ``no benefits shall be payable.'' The regulations
therefore exclude brothers and sisters from reentitlement once they
marry.
(c) One comment states that reentitling a surviving spouse after
the termination of his or her intervening marriage is contrary to the
SSA regulations implementing part B of the BLBA. The comment is
incorrect. Section 410.211(a) provides that payment of benefits
terminates if a surviving spouse or divorced wife remarries while
receiving benefits; however, ``[s]hould the remarriage subsequently
end, payment of benefits may be resumed * * * .'' 20 CFR 410.211(a).
Sections 725.213 and 410.211 are therefore entirely consistent.
(d) Two comments support the new subsection (c).
(e) No other comments concerning this section were received, and no
changes have been made in it.
20 CFR 725.214
(a) The Department proposed amending Sec. 725.214 in the initial
notice of proposed rulemaking to conform the regulatory criteria for
marital relationships to intervening changes in the law since the
regulation was issued in 1978. 62 FR 3349-50 (Jan. 22, 1997).
Specifically, the Department intended this regulation (as well as
Sec. 725.204) to reflect statutory changes which now permit the
surviving spouse of a miner, whose marriage is invalid due to a legal
impediment, to receive benefits notwithstanding the existence of a
legally-married spouse who also is receiving benefits. Consequently,
the Department proposed eliminating language in 20 CFR 725.214(d) which
required the termination of benefits for the surviving spouse whose
marriage is invalid upon the entitlement of the legal spouse. The
Department proposed no additional changes to this regulation in the
second notice of proposed rulemaking. 64 FR 54971 (Oct. 8, 1999). For
purposes of this rule, the Department has corrected one typographical
error and made minor grammatical changes. The first and second notices
of proposed rulemaking used the word ``interstate'' in Sec. 725.214(c)
to describe a miner's personal property. 62 FR 3391 (Jan. 22, 1997); 64
FR 55027 (Oct. 8, 1999). The correct word is ``intestate,'' and that
word has been substituted in the regulation. In Sec. 725.214(d), the
Department has deleted the word ``and'' which immediately followed the
phrase ``in a purported marriage between them,'' and added commas, as
appropriate, to clarify the meaning of the provision.
(b) One comment objects to permitting a surviving spouse, whose
marriage to the deceased miner may be invalid due to certain legal
impediments, to maintain eligibility despite another person's
eligibility as the miner's surviving spouse. The commenter states
generally that the provision is contrary to the Social Security Act
(SSA) and imposes an unwarranted increase in benefits liability.
Neither objection demonstrates any basis for abandoning the revision.
The Department proposed the same change in connection with
Sec. 725.204, and provided a detailed legal analysis of the reasons
supporting the revision in its initial notice of proposed rulemaking.
See 62 FR 3349-50 (Jan. 22, 1997). The Black Lung Benefits Act (BLBA)
incorporates the definition of a dependent ``wife'' used by the SSA, 42
U.S.C. 416(h)(1), as incorporated by 30 U.S.C. 902(a)(2), (e). The SSA
recognizes both ``legal'' and ``deemed'' spouses as potentially
eligible for benefits on a single wage earner's record. The ``deemed''
spouse is an individual who married the wage earner while unaware that
some legal impediment existed to the marriage. Before 1990, Sec. 416(h)
prohibited a ``deemed spouse'' from receiving benefits if a ``legal''
spouse existed and was receiving benefits on the wage earner's account.
42 U.S.C. 416(h)(1)(B). The Department imposed a similar limitation in
the dependency criteria when it promulgated 20 CFR 725.204(d)(1). In
1990, Congress amended the SSA to remove the prohibition on ``deemed
spouse'' entitlement if a legal spouse existed and was receiving
benefits. 104 Stat. 1388-278 to 1388-280 (1990). Legislative history
clearly established Congressional intent to permit both the ``deemed''
spouse and the legal spouse to receive concurrent benefits. See H.R.
Rep. No. 101-964, 1990 U.S.C.C. & A.N. 2649, 2650 (conference report).
Accordingly, the Department proposed similar changes to Sec. 725.214 to
delete the regulatory bar to ``deemed'' spouse entitlement under the
BLBA. The comment does not respond to this analysis with any specific
reasoning demonstrating the alleged inconsistency with the SSA or
refuting the Department's authority to implement this change. Finally,
increased benefits liability alone is not a legitimate basis for
denying benefits to eligible claimants under the BLBA.
(c) No other comments concerning this section were received, and no
other changes have been made in it.
20 CFR 725.215
(a) In the initial notice of proposed rulemaking, the Department
proposed clarifying the intended operation of Sec. 725.215(g)(3) by
changing a reference in that regulation from ``section'' to
``paragraph.'' 62 FR 3391 (Jan. 22, 1997). The change ensures that the
exception to the nine-month marriage rule is confined to subsection (g)
rather than applicable to the entire regulation. 62 FR 3351 (Jan. 22,
1997). The Department proposed no additional changes to this regulation
in the second notice of proposed rulemaking. 64 FR 54971 (Oct. 8,
1999).
(b) No comments concerning this section were received, and no
changes have been made in it.
20 CFR 725.219
(a) In the initial notice of proposed rulemaking, the Department
proposed changing Sec. 725.219 to account for a change in the age of
onset of disability in the Social Security Act (SSA), 42 U.S.C.
402(d)(1)(B), which is incorporated into the Black Lung Benefits Act's
(BLBA) definition of ``child,'' 30 U.S.C. 902(g). 62 FR 3350 (Jan. 22,
1997). The Department did not propose any additional changes in the
second notice of proposed rulemaking. 64 FR 54971 (Oct. 8, 1999). The
Department, however, did assert in general terms that marriage is a
[[Page 79966]]
permanent bar to future entitlement for any individual other than a
miner's surviving spouse or surviving divorced spouse. 64 FR 54983-84
(Oct. 8, 1999). Based on this position, the Department withdrew a
proposed change to Sec. 725.223 which extended reentitlement to a
miner's surviving dependent brother or sister if the sibling married
while receiving benefits, but the marriage later ended.
(b) Two comments recommend adopting a provision (analogous to
Sec. 725.213(c)) which would allow a deceased miner's surviving
disabled child, whose entitlement terminates upon marriage, to regain
eligibility when that marriage ends. Formerly, the regulations
permitted a child whose entitlement terminated at age 18 to apply for
reinstatement if the child was a student, younger than age 23, and was
not married. 20 CFR 725.219(c). The regulations did not make any
provision for reentitling a disabled child whose entitlement is
terminated by marriage. The Department agrees with the comments that
such a provision is appropriate, and therefore has added subsection
(d). This provision enables a child whose entitlement terminates upon
marriage to apply for reinstatement of benefits once the marriage
terminates. Subsection (d) also excuses the child-beneficiary from any
requirement to reestablish the deceased miner's total disability or
death due to pneumoconiosis.
The BLBA provides that survivor's benefits ``shall only be paid to
a child for so long as he meets the criteria for the term `child'
contained in section 402(g).'' 30 U.S.C. 922(a)(3). Section 402(g)
defines ``child'' to mean a:
child or a stepchild who is--
(1) unmarried; and
(2)(A) under eighteen years of age, or
(B)(i) under a disability as defined in section 423(d) of title 42
(ii) which began before the age specified in section
402(d)(1)(B)(ii) of title 42, or, in the case of a student, before he
ceased to be a student; or
(C) a student.
30 U.S.C. 902(g). The literal language of the statute does not preclude
a child's eligibility for all time based upon the existence of a
marriage. Rather, the two statutory provisions authorize the payment of
benefits to an eligible child survivor ``for so long as'' (s)he ``is
unmarried.'' If a marriage terminates prior to any period of
eligibility, the child is nevertheless unmarried when (s)he becomes
entitled to benefits. See Adler v. Peabody Coal Co., Black Lung Rep.,
BRB No. 98-1513 BLA (Feb. 4, 2000). If the child marries while
receiving benefits, (s)he cannot continue as an eligible survivor for
the duration of the marriage. Sullenberger v. Director, OWCP, Black
Lung Rep., BRB No. 99-0449 BLA (March 8, 2000) Upon cessation of the
marital relationship, however, the child again ``is unmarried,'' which
complies with the statutory requirement. Assuming all other conditions
for eligibility are met, an ``unmarried'' child retains his or her
status as a ``child'' under the plain language of the statute
notwithstanding the occurrence of the marriage. In this regard, the
Department disagrees with the broad statement in Reigh v. Director,
OWCP, 20 Black Lung Rep. 1-44 (1996), that a surviving child of a miner
cannot revive her status as the unmarried dependent of her parents upon
the death of her husband. 20 Black Lung Rep. at 1-48.
The Department's interpretation of the plain language of
Sec. 402(g) gains support from Congress' decision to omit certain
provisions of 42 U.S.C. 402(d) (the Social Security Act) from the BLBA.
Significantly, Congress did not incorporate Sec. 402(d)(6), which
permits a child to become reentitled to benefits after turning 18 if
the child is a student under age 22 or disabled, ``provided no event
specified in paragraph (1)(D) has occurred.'' 42 U.S.C. 402(d)(6).
Section 402(d)(1)(D) states that a child's benefits terminate ``the
month preceding * * * the month in which such child dies or
marries[.]'' In McMahon v. Califano, 605 F.2d 49 (2d Cir. 1979), cert.
den. 444 U.S. 847 the Court held that ``the only reasonable
interpretation of [Sec. 402(d)(6) and (d)(1)(D)] is that any marriage
occurring subsequent to a child's initial entitlement to benefits
terminates those benefits and prevents re-entitlement in the future.''
605 F.2d at 53; see also Downs v. D.C. Police & Firefighters Retirement
and Relief Bd., 666 A.2d 860 (D.C.C.A. 1995) (holding disabled child's
annuity permanently terminated when child married and later divorced).
Otherwise, the Court concluded, the proviso language of Sec. 402(d)(6)
would be superfluous because no other interpretation would afford it
any meaning. Congress therefore has implemented a policy determination
that a disabled child receiving SSA benefits should become permanently
ineligible if the child marries, regardless of the subsequent
termination of the marriage. By omitting the incorporation of these
provisions into the BLBA definition of ``child,'' however, the
Department concludes that Congress did not intend to adopt the same
policy for the BLBA.
The legislative history of the definition of ``child'' does not
support a contrary interpretation. The BLBA originally defined
``dependent'' to mean a dependent wife or child within the meaning of 5
U.S.C. 8110; ``wife'' and ``child'' were not defined separately. 30
U.S.C. 902(a) (1969). Section 8110 defined a dependent child as an
``unmarried child'' living with, or receiving regular contributions
from, the employee if the child is under 18 years of age; over that age
but incapable of self-support because of a physical or mental
impairment; or a student. 5 U.S.C. 8110(a)(3). In 1972, Congress
amended the BLBA to include a new definition of ``dependent'' and
separate definitions of ``child'' and ``widow.'' 30 U.S.C. 902(a), (g),
(e) (1972). The legislative history of the 1972 amendments simply
states that the statutory definition of ``child'' conformed to the SSA
definition. S. Rep. No. 743, 92nd Cong., 2nd Sess. (1972), reprinted in
Senate Subcommittee on Labor, Committee on Labor and Public Welfare,
94th Cong., 1st Sess., History of the Federal Coal Mine Health and
Safety Act of 1969, as amended through 1974, Part 2--Appendix at 1946,
1974 (1975). That conformance extended only to the specific adoption of
SSA eligibility criteria for age, disability, and student requirements,
but did not include provisions such as the permanent ban on
reentitlement for a child who marries in Sec. 402(d)(6). Consequently,
the Department is free to depart from the SSA eligibility scheme
contained in Sec. 402(d)(6) by permitting reentitlement.
The effect of marriage on a claimant's eligibility has also arisen
in connection with a miner's surviving spouse. 30 U.S.C. 902(e). Since
the 1972 amendments, the statutory definition of ``widow'' has limited
eligibility to a miner's surviving spouse or surviving divorced spouse
``who is not married.'' Legislative history linking the 1972 amendment
of 30 U.S.C. 902(e) to changes in the parallel SSA definition clearly
establish Congress' intention to permit reentitlement for a widow who
remarried after the beneficiary's death and later became unmarried. See
generally Wolf Creek Collieries v. Robinson, 872 F.2d 1264, 1266 (6th
Cir. 1989); Luchino v. Director, OWCP, 8 Black Lung Rep. 1-453, 1-456
(1986). The statutory definitions of ``widow'' and ``child'' are alike
in that both require the individual to be unmarried as a condition of
eligibility. The legislative history of the Black Lung Benefits Act's
1972 amendments strongly supports limiting the effect of an intervening
marriage on a surviving spouse's eligibility, and does not contradict
affording the same treatment
[[Page 79967]]
to a child. In the absence of such contradictory evidence of Congress'
intentions, both statutory definitions should be construed alike given
the similarities in their language. Accordingly, a presently unmarried
child of a miner is eligible for benefits notwithstanding any prior
marriage. The marriage merely suspends the child's eligibility for
benefits for the duration of the marriage if the child marries during a
period of entitlement. Eligibility then resumes upon termination of the
marriage, assuming all other conditions of eligibility can be
satisfied. If the child's marriage terminates prior to any period of
entitlement, the marriage has no effect upon the child's eligibility.
(c) No other comments concerning this section were received, and no
other changes have been made in it.
20 CFR 725.221
(a) The Department proposed changing the date of onset of
disability in Sec. 725.221 from 18 to 22 years of age to conform the
regulation to the same change in 42 U.S.C. 423(d). 62 FR 3350, 3392
(Jan. 22, 1997). The Department proposed no additional changes in the
second notice of proposed rulemaking. 64 FR 54791 (Oct. 8, 1999).
(b) One comment supported the change in the age by which disability
must commence.
(c) No other comments were received concerning this section, and no
changes have been made in it.
20 CFR 725.222
(a) The Department proposed changing the date of onset of
disability in Sec. 725.222 from 18 to 22 years of age to conform the
regulation to the same change in 42 U.S.C. 423(d). 62 FR 3350, 3392
(Jan. 22, 1997). The Department proposed no additional changes in the
second notice of proposed rulemaking. 64 FR 54791 (Oct. 8, 1999).
(b) One comment recommends that subsection (b) allow a deceased
miner's parent, brother or sister to claim benefits unless the miner's
surviving spouse or child has established entitlement. The Department
rejects this change because it is inconsistent with the Black Lung
Benefits Act. Section 412 of the Act provides guidelines for the
payment of benefits to eligible beneficiaries. 30 U.S.C. 922. Section
412(a)(5) states, in pertinent part, that a dependent parent of a
deceased miner ``who is not survived at the time of [the miner's] death
by a widow or a child'' is eligible for benefits. 30 U.S.C. 922(a)(5).
The same provision also states that a dependent surviving sibling of
the deceased miner ``who is not survived at the time of [the miner's]
death by a widow, child, or parent'' is eligible for benefits. The
current language in 20 CFR 725.222(b) follows the statutory language,
and no change in that subsection is appropriate. The statutory
provisions are unequivocal: the existence of a surviving spouse or
child is sufficient to preclude entitlement for other survivors even if
the spouse or child is not receiving benefits.
This interpretation is further supported by another provision of
section 412. Paragraph (a)(3) states that ``no entitlement to benefits
as a child shall be established under this paragraph (3) for any month
for which entitlement to benefits as a widow is established under
paragraph (2).'' 30 U.S.C. 922(a)(3). Under this provision, a child may
receive benefits even if a surviving spouse exists unless (or until)
the spouse establishes his or her own entitlement and supersedes the
child as the primary beneficiary. By using different eligibility
criteria within the same statutory provision, Congress drew a clear
distinction between the circumstances in which the existence of an
eligible surviving spouse could preclude any potential beneficiary with
lesser standing from obtaining benefits. The child may therefore
constitute a primary beneficiary until such time as the spouse asserts
(and proves) his or her own entitlement; at that time, the spouse
replaces the child as the beneficiary. The mere existence of a
surviving spouse or child, however, does preclude an otherwise eligible
parent or sibling from claiming benefits. The commenter's recommended
change would violate the distinction between classes of eligible
beneficiaries which Congress has drawn. The recommendation must be
rejected.
(c) One comment supported the change in age, from 18 to 22, by
which disability must commence.
(d) No other comments concerning this section were received, and no
changes have been made in it.
20 CFR 725.223
(a) In the initial notice of proposed rulemaking, the Department
proposed revising Sec. 725.223 to adopt the change in age limits for
disability specified by 42 U.S.C. 402(d)(1)(B), as incorporated by the
Black Lung Benefits Act (BLBA), 30 U.S.C. 922(a)(5). 62 FR 3351, 3393
(Jan. 22, 1997). The Department also proposed adding subsection (d) to
permit reentitlement for a miner's dependent brother or sister whose
eligibility had terminated upon marriage, provided the marriage ended
and the individual again fulfilled all the eligibility criteria. The
Department thereafter reconsidered this proposal, and suggested its
removal in the second notice of proposed rulemaking. 64 FR 55029 (Oct.
8, 1999). The Department concluded that the proposed subsection (d)
contradicted longstanding agency policy, which permitted reentitlement
upon cessation of marriage only in the case of a surviving spouse.
Because the Department stated it considered a miner's children
permanently barred from reentitlement upon the cessation of marriage,
it declined to afford preferential treatment to the miner's siblings.
In the case of a married sibling who becomes the miner's dependent, the
Department concluded that eligibility should not be precluded by the
existence of the marriage if the sibling's spouse provided no support.
Once a married sibling received support or an unmarried dependent
married, however, the Department relied on the assumption that the
married sibling would receive support from the spouse and a sibling
whose marriage terminated would rely on savings or property from the
marriage, etc. 64 FR 54983-84 (Oct. 8, 1999).
(b) The Department has changed its position that reentitlement for
beneficiaries after resumption of unmarried status must be confined to
surviving spouses and surviving divorced spouses. See Sec. 725.219(d)
above, with respect to children. Although the Department recognizes
reentitlement for children as well as spouses, the Department has not
changed its views about the effect of marriage as a permanent bar to
reentitlement for a miner's brother or sister. The BLBA supports this
policy. Section 412(a)(5) states that ``[n]o benefits to a sister or
brother shall be payable under this paragraph for any month beginning
with the month in which he or she * * * marries.'' 30 U.S.C. 922(a)(5).
This provision is unequivocal. Once a brother or sister who is
receiving benefits marries, eligibility terminates. That the
termination is permanent may be inferred from the phrasing of the
provision: upon marriage, no benefits are payable to the sibling ``for
any month'' starting with the month of the marriage. Section 412(a)(5)
does not include any qualifying language which would suggest that
benefits are not payable simply for the duration of the marriage.
Rather, it identifies a point when ineligibility commences, with no
provision for restoring eligibility. In this regard, section 412(a)(5)
differs from the statutory definitions of ``widow'' and ``child,'' 30
U.S.C. 902(e), (g). Section 412(a)(5) links the occurrence of an event
to the termination of eligibility
[[Page 79968]]
while the ``widow'' and ``child'' definitions focus on the individual's
status. The widow's or child's marriage status can change; consequently
these individuals can move in or out of eligibility. Once a brother or
sister marries, ``no benefits shall be payable * * *.'' The BLBA
therefore requires that a miner's brothers and sisters be excluded from
reentitlement upon the dissolution of marriage.
(c) One comment endorses the withdrawal of proposed subsection (d),
and a return to current practice with respect to the marriage of a
miner's brothers and sisters.
(d) No other comments concerning this section were received, and no
changes have been made in it.
Subpart C
20 CFR 725.306
(a) In its first notice of proposed rulemaking, the Department
proposed revising Sec. 725.306(a)(3) by cross-referencing Sec. 725.522
so that an unrelated revision of the term ``benefits'' in section
725.101(a)(6) would not adversely affect a claimant's ability to
withdraw his claim for benefits. The Department specifically noted its
intention not to require reimbursement of the amount spent on the
claimant's complete pulmonary evaluation as a condition for withdrawal
of a claim, notwithstanding its proposal to include the complete
pulmonary evaluation within the definition of ``benefits.'' 62 FR 3351
(Jan. 22, 1997). The Department did not discuss section 725.306 in its
second notice of proposed rulemaking. See list of changes in the
Department's second proposal, 64 FR 54971 (Oct. 8, 1999).
(b) Several comments opposed the revised definition of
``benefits,'' Sec. 725.101(a)(6), because it includes the cost of the
miner's complete pulmonary examination for which the Department is
liable in the absence of a final award of benefits. The commenters
believe the revised definition will impose liability on the miner under
Sec. 725.306 for repayment of the cost of the examination if he should
decide to withdraw his claim. For the reasons stated in the
Department's initial notice of proposed rulemaking, 62 FR 3351 (Jan.
22, 1997), and in response to comments received in connection with
Sec. 725.101(a)(6), 64 FR 54982 (Oct. 8, 1999), the Department has not
made reimbursement of the examination ``benefit'' a price for
withdrawing a claim. No other comments were received concerning this
section, and no changes have been made in it.
20 CFR 725.308
Although the Department received comments relevant to this section,
the regulation was not open for comment, see 62 Fed. Reg. 3341 (Jan.
22, 1997); 64 Fed. Reg. 54971 (Oct. 8, 1999). It was repromulgated only
for the convenience of readers. Accordingly, no changes are being made
in this section.
20 CFR 725.309
(a) In its first notice of proposed rulemaking, the Department
proposed revising Sec. 725.309 to clarify the rule governing subsequent
claims. 62 FR 3351 (Jan. 22, 1997). A subsequent claim is an
application filed by the same individual after final denial of a prior
claim. The Department observed that a majority of the federal appellate
courts that had considered the issue had deferred to the Department's
interpretation of the former regulation governing such claims. That
regulation required a claimant to establish that he had suffered a
material change in condition since the denial of his earlier claim in
order to escape the denial of the later claim on the grounds of the
prior denial. 20 CFR 725.309 (1999). The Department's interpretation of
that rule allowed miners to establish the necessary material change in
condition by introducing new evidence that demonstrated a change in one
of the necessary elements of entitlement, such as the existence of
pneumoconiosis. The Department proposed to codify its interpretation by
creating a rebuttable presumption that the miner's condition had
changed if new evidence established one of the elements of entitlement
previously resolved against the miner. An operator could rebut the
presumption by establishing that the earlier denial was erroneous,
i.e., that the new evidence submitted by the claimant did not
demonstrate a change in his condition but simply that the earlier
determination was mistaken. If the presumption was not rebutted, the
factfinder would weigh all of the evidence on the remaining elements of
entitlement to determine whether the claimant was entitled to benefits.
The original proposal also provided that the remaining issues of
entitlement were subject to de novo adjudication unless the parties had
stipulated to, or waived their right to contest, those issues in the
earlier proceeding. Thus, once the claimant established a change in his
condition, no parties to the claim were entitled to rely on findings
made in connection with the denial of the prior claim.
The Department substantially revised its proposal in its second
notice of proposed rulemaking. 64 FR 54984-85 (Oct. 8, 1999). The
Department deleted the rebuttable presumption and substituted a
threshold test which allowed the miner to litigate his entitlement to
benefits without regard to any previous findings by producing new
evidence that established any of the elements of entitlement previously
resolved against him. The Department explained that this test
effectuated the Fourth Circuit's decision in Lisa Lee Mines v.
Director, OWCP, 86 F.3d 1358 (4th Cir. 1996), cert. denied, 117 S. Ct.
763 (1997), by accepting the correctness of the earlier denial of
benefits. In addition, in response to several comments, the Department
restored a provision requiring the denial of an additional survivor's
claim, but limited the circumstances in which such a denial was
appropriate. The Department proposed the automatic denial of an
additional survivor's claim in cases in which the denial of the
previous claim was based solely on a finding or findings that were not
subject to change. For example, if the earlier claim was denied solely
because the miner did not die due to pneumoconiosis, the regulation
would require the denial of any additional claim as well. The
Department responded to other comments, rejecting the suggestion that
the revised regulation was inconsistent with Sec. 22 of the Longshore
and Harbor Workers' Compensation Act, 33 U.S.C. 922, as incorporated by
30 U.S.C. 932(a), and Sec. 413(d) of the Black Lung Benefits Act, 30
U.S.C. 923(d). Finally, the Department discussed why findings favorable
to the claimant that were made in the previous denial of benefits
should not be given preclusive effect, and clarified the date from
which benefits were payable in the event an additional claim was
awarded.
(b) Two comments object to the Department's rule allowing
subsequent claims on the basis that the record lacks adequate
justification of the latency and progressivity of pneumoconiosis. In
its first notice of proposed rulemaking, the Department proposed
revising the definition of the term ``pneumoconiosis'' in Sec. 718.201
to, among other things, explicitly recognize that it referred to a
progressive disease. 62 FR 3343-44 (Jan. 22, 1997). Several commenters
argued that the Department's proposed definition was scientifically
unsound, and presented testimony from a panel of physicians with
expertise in pulmonary medicine at the Department's July 22, 1997
hearing in Washington, D.C. The Department also received comments and
testimony in support of its proposal.
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