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Regulations Implementing the Federal Coal Mine Health and Safety Act of 1969, as Amended [Proposed Rules] [10/08/1999]

ESA Proposed Rule

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Regulations Implementing the Federal Coal Mine Health and Safety Act of 1969, as Amended [10/08/1999]

Volume 64, Number 195, Page 55065-55072

The text of the Preliminary Regulatory Flexibility Analysis, Proposed Regulations Implementing the Federal Coal Mine Health and Safety Act of 1969, is available for review in either .pdf or Word format.

Due to the large file size, this document has been divided into three parts:

[Pages 54965 - 55014] [PDF] [Pages 55015 - 55064] [PDF] [Pages 55065 - 55072] [PDF]
[Federal Register: October 8, 1999 (Volume 64, Number 195)]
[Proposed Rules]               
[Page 54965-55014]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08oc99-52]                         
 

[[Page 54965]]

_______________________________________________________________________

Part II





Department of Labor





_______________________________________________________________________



Employment Standards Administration



_______________________________________________________________________



20 CFR Part 718 et al.



Regulations Implementing the Federal Coal Mine Health and Safety Act of 
1969; Proposed Rule


[[Page 54966]]



DEPARTMENT OF LABOR

Employment Standards Administration

20 CFR Parts 718, 722, 725, 726, and 727

RIN 1215-AA99

 
Regulations Implementing the Federal Coal Mine Health and Safety 
Act of 1969, as Amended

AGENCY: Employment Standards Administration, Labor.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: On January 22, 1997, the Department issued a proposed rule to 
amend the regulations implementing the Black Lung Benefits Act. The 
Department initially allowed interested parties until March 24, 1997 to 
file comments, but extended that deadline twice. When the comment 
period finally closed on August 21, 1997, the Department had received 
almost 200 written submissions from coal miners, coal mine operators, 
insurers, physicians, and attorneys. In addition, the Department held 
two hearings, one on June 19, 1997 in Charleston, West Virginia, and 
another on July 22-23, 1997 in Washington, D.C. Over 50 people 
testified at the Department's hearings. In total, the Department heard 
from over 100 former coal miners and members of their families, over 50 
coal mine operators and insurance companies that provide black lung 
benefits insurance, eight physicians, eight attorneys representing both 
claimants and coal mine operators, nine legislators at the federal and 
state levels, and groups as diverse as the United Mine Workers of 
America, the National Black Lung Association, the National Mining 
Association, the American Insurance Association, and the American Bar 
Association.
    The Department has reviewed all of the comments and testimony, and 
has decided to issue a second proposal, revising a number of the most 
important regulations contained in the earlier proposal. In some cases, 
the Department has proposed additional changes to these regulations. In 
other cases, the Department has explained its decision not to alter its 
proposal based on the comments received to date. Finally, the 
Department has prepared an initial regulatory flexibility analysis. The 
Department's second proposal is intended to accomplish two purposes. 
First, it will provide notice to all interested parties of the proposed 
revisions, as well as of the initial regulatory flexibility analysis 
set forth in this document. Second, the re-proposal will allow small 
entities that may have been unaware of the Department's earlier 
proposal to submit comments on the entire proposed rule.

DATES: Comments must be submitted on or before December 7, 1999.

ADDRESSES: All comments concerning these proposed regulations should be 
addressed to James L. DeMarce, Director, Division of Coal Mine Workers' 
Compensation, Room C-3520, Frances Perkins Building, 200 Constitution 
Ave., NW., Washington, DC 20210.

FOR FURTHER INFORMATION CONTACT: James L. DeMarce, (202) 693-0046.

SUPPLEMENTARY INFORMATION:
    This notice reprints 20 CFR Parts 718, 722, 725, and 726 in their 
entirety for the convenience of interested parties. This notice thus 
necessarily includes proposed revisions contained in the Department's 
original notice of proposed rulemaking. 62 FR 3338 (Jan. 22, 1997). The 
Department intends this notice to supplement the original notice, 
however, and not to replace it. To the extent that previously proposed 
regulatory changes have not been altered by the revisions contained in 
this notice, the explanation of those changes contained in the 
Department's initial notice remains valid. Where the Department has 
proposed additional changes, those changes are explained below.

Summary of Noteworthy Proposed Regulations

Evidentiary Development

Documentary Medical Evidence
    The Department's initial proposal governing evidentiary development 
in black lung claims resulted in the greatest volume of public comment, 
from coal mine operators, their insurers, claims servicing 
organizations and miners. Many commenters were critical of the 
Department's proposal that all documentary medical evidence was to be 
submitted to the district director in the absence of extraordinary 
circumstances. Numerous commenters, expressing widely varying points of 
view, also addressed the proposed limitation on the amount of 
documentary medical evidence that each side could submit in a given 
claim.
    After carefully considering the many valid objections to the 
required submission of documentary medical evidence to the district 
director, the Department now proposes to retain the current process for 
submitting documentary medical evidence into the record. Under this 
process, parties may submit documentary medical evidence either to the 
district director or to an administrative law judge (ALJ) up to 20 days 
before an ALJ hearing, or even thereafter, if good cause is shown. This 
proposal does retain, however, the Department's original limitation on 
the amount of documentary medical evidence which may be submitted in 
each claim. To clarify its intent, the Department has defined 
differently the applicable evidentiary limitations. These limitations 
are now expressed in terms of the types of evidence most commonly used 
to establish or refute entitlement to benefits under Secs. 718.202 and 
718.204. Thus, rather than describing the evidentiary limitations in 
terms of two pulmonary evaluations or consultative reports, the revised 
Sec. 725.414 speaks in terms of two chest X-ray interpretations, the 
results of two pulmonary function tests, two arterial blood gas 
studies, and two medical reports.
    The revised Sec. 725.414 also would make explicit the amount of 
evidence which each side may submit in rebuttal of its opponent's case. 
A party may submit no more than one physician's interpretation of each 
chest X-ray, pulmonary function test, or arterial blood gas study 
submitted by its opponent. In addition, the Department proposes to 
permit a party to rehabilitate evidence that has been the subject of 
rebuttal. For example, where a party submits a physician's 
interpretation in rebuttal of a chest X-ray interpretation or objective 
test, the party that originally submitted the chest X-ray or test into 
evidence may introduce a contrary statement from the physician who 
originally interpreted it.
    This proposal would alter in one significant way the limitations on 
the amount of medical evidence admissible in each claim. In order to 
allow for a more careful consideration of the unique facts and 
circumstances of each case, and to provide an additional procedural 
safeguard, this proposal would permit an administrative law judge to 
admit medical evidence into the record in excess of the limits outlined 
in Sec. 725.414 upon a showing of good cause. The Department's prior 
proposal would have permitted the admission of such evidence only if a 
moving party could demonstrate extraordinary circumstances.
Complete Pulmonary Evaluation
    The Department also proposes a change in the manner in which it 
administers the complete pulmonary evaluation required by the Black 
Lung Benefits Act. Under the Department's original proposal, a miner 
could be examined either by a physician selected

[[Page 54967]]

by the Department or by a physician of his choosing. If the miner 
selected the physician, however, the report of that examination would 
have counted as one of the two pulmonary evaluations the miner was 
entitled to submit into evidence. The Department now proposes to allow 
the miner to choose the physician or facility to perform the complete 
pulmonary evaluation from a list of providers maintained by the 
Department. The authorized list of physicians and facilities in a given 
case would include all those in the state of the miner's residence and 
contiguous states. If, however, a miner chose a provider more than one 
hundred miles from his residence to administer the 413(b) evaluation, 
the designated responsible operator could choose to send the miner a 
comparable distance for its examination. The 413(b) examination results 
would not count against the miner's quota. Sec. 725.406.
    The Department believes that this proposal would benefit all 
parties to a claim. It would make possible the best quality respiratory 
and pulmonary evaluation and would insure each miner a thorough 
examination, performed in compliance with the applicable quality 
standards. Such a pulmonary evaluation would therefore give the 
Department a sound evidentiary basis upon which to make an initial 
finding, a finding which both the claimant and the operator may find 
credible. The Department intends to develop more rigorous standards for 
physicians and facilities that perform pulmonary evaluations and to 
reevaluate the fees it pays physicians to perform and explain the 
results of these examinations. The Department has discussed in the 
preamble to Sec. 725.406 several possible criteria that the Office 
might use in selecting appropriate physicians and facilities, and 
invites comment on these and other possible criteria.
    Developing medical evidence relevant to the claimant's respiratory 
and pulmonary condition, including the objective medical testing 
required by the Department's quality standards, may involve costs 
beyond the reach of some claimants. Thus, this proposal would require a 
district director to inform the claimant that he may have the results 
of the Department's initial objective testing sent to his treating 
physician for use in the preparation of a medical report that complies 
with the Department's quality standards. The district director's notice 
would also inform the claimant that, if submitted, a report from his 
treating physician would count as one of the two reports he is entitled 
to submit under Sec. 725.414, and that he may wish to seek advice, from 
a lawyer or other qualified representative, before requesting his 
treating physician to supply such a report. In this way, the Department 
hopes to assist claimants who may not be able to afford the necessary 
objective testing.
Documentary Evidence Pertaining to the Liability of a Potentially 
Liable Operator or the Responsible Operator
    Although the Department now proposes to allow the submission of new 
documentary medical evidence while a case is pending before the Office 
of Administrative Law Judges, it has not altered the proposal with 
respect to the required submission to the district director of all 
documentary evidence relevant to potentially liable operators and the 
responsible operator. Proposed Secs. 725.408, 725.414 and 725.456 would 
continue to require that such evidence be submitted to the district 
director and that an administrative law judge may admit additional 
evidence on such issues only if the party seeking to submit the 
evidence demonstrates extraordinary circumstances justifying its 
admission. The Department has revised proposed Sec. 725.408, however, 
in response to operators' comments. That section would now allow an 
operator, notified of its potential liability under proposed 
Sec. 725.407, 90 days, rather than 60, to submit documentary evidence 
challenging the district director's determination that it meets the 
requirements in Sec. 725.408(a)(2). In addition, the 90 day period 
could be extended for good cause pursuant to Sec. 725.423.
Witnesses
    This proposal alters the provisions governing witnesses testimony. 
Secs. 725.414, 725.456, 725.457. The revisions would allow a physician 
to testify, either at a hearing or pursuant to deposition, if he 
authored a ``medical report'' admitted into the record pursuant to 
Sec. 725.414. Alternatively, if a party has submitted fewer than the 
two medical reports allowed as an affirmative case, a physician who did 
not prepare a medical report could testify in lieu of such a report. No 
party would be allowed to offer the testimony of more than two 
physicians, however, unless the administrative law judge found good 
cause to allow evidence in excess of the Sec. 725.414 limitations. The 
Department also has proposed altering its original limitation on the 
scope of a physician's testimony. If a physician is permitted to 
testify, he may testify as to any medical evidence of record, and not 
solely with respect to the contents of the report he prepared.
    The regulations governing witnesses testimony would continue to 
require that the parties notify the district director of any potential 
witness whose testimony pertains to the liability of a potentially 
liable operator or the responsible operator. Absent such notice, the 
testimony of such a witness may not be admitted into a hearing record 
absent an administrative law judge's finding of extraordinary 
circumstances. Secs. 725.414, 725.457.
Witnesses' Fees
    The Department received comments from both miners and coal mine 
operators criticizing its initial proposal, which would have assessed 
liability for witnesses' fees on the party seeking to cross-examine a 
witness if the witness's proponent did not intend to call the witness 
to appear at the hearing. In response to these objections, the 
Department now proposes to assess the costs of cross-examination of a 
witness on the party relying on that witness's affirmative testimony. 
This change will make the regulation more consistent with the manner in 
which witnesses' fees are paid in general litigation. Under the 
proposal, the party whose witness is to be cross-examined may request 
the administrative law judge to authorize a less burdensome method of 
cross-examination than an actual appearance at a hearing, provided that 
the alternative method authorized will produce a full and true 
disclosure of the facts.
    The only exception to this general rule would be in the case of an 
indigent claimant. If a claimant is the proponent of the witness whose 
cross-examination is sought, and the claimant demonstrates that he 
would be deprived of ordinary and necessary living expenses if required 
to pay the witness's fee and mileage necessary to produce the witness 
for cross-examination, the administrative law judge may apportion the 
costs of the cross-examination between the parties, up to and including 
the assessment of the total cost against the party opposing claimant's 
entitlement. A claimant shall be considered deprived of funds required 
for ordinary and necessary living expenses under the standards set 
forth at 20 CFR 404.508. The Black Lung Disability Trust Fund may not 
be held liable for such witness's fee in any case in which the district 
director has designated a responsible operator, except that the fund 
may be assessed the cost associated with the cross-examination of the 
physician who performed the miner's complete pulmonary evaluation.

[[Page 54968]]

Subsequent Claims
    Subsequent applications for benefits are filed more than one year 
after the denial of a previous claim and may be adjudicated only if the 
claimant demonstrates that an applicable condition of entitlement has 
changed in the interim. In its initial notice of proposed rulemaking, 
the Department attempted to clarify the regulation governing subsequent 
claims by summarizing and incorporating into the regulation's language 
the outcome of considerable appellate litigation. 62 FR 3351-3353 (Jan. 
22, 1997). Because the courts of appeals have issued additional 
decisions since the Department's initial proposal, the proposal now 
merely codifies caselaw that is already applicable to more than 90 
percent of the claimants who apply for black lung benefits. The 
Department's complete discussion of the numerous comments received in 
response to the first notice of proposed rulemaking is found under 
Sec. 725.309.
    This second proposal contains two changes to Sec. 725.309 as 
initially proposed. Both changes affect Sec. 725.309(d)(3). The 
Department now proposes elimination of the rebuttable presumption that 
the miner's physical condition has changed if the miner proves with new 
medical evidence one of the applicable conditions of entitlement. 
Commenters responded that the proposal was confusing and would lead to 
considerable litigation. The Department agrees that the presumption is 
unnecessary and suggests its deletion. Under the new proposal, a 
subsequent claim will be denied unless the claimant demonstrates that 
one of the applicable conditions of entitlement has changed since the 
date upon which the order denying the prior claim became final. Section 
725.309(d)(3) of this proposal also clarifies the Department's original 
intent with respect to subsequent survivors' claims. In order to avoid 
an automatic denial, the applicant in a subsequent survivor's claim 
must demonstrate that at least one of the applicable conditions of 
entitlement is unrelated to the miner's physical condition at the time 
of his death. Thus, if the prior denial was based solely on the 
survivor's failure to establish that the miner had pneumoconiosis, that 
the miner's pneumoconiosis was caused by coal mine employment, or that 
the pneumoconiosis contributed to the miner's death, any subsequent 
claim must also be denied, absent waiver by the liable party.
    By allowing the filing of a subsequent claim for benefits which 
alleges a worsening of the miner's condition, the Department merely 
recognizes the progressive nature of pneumoconiosis. The proposed 
regulation does not allow the reopening of any prior claim which was 
denied more than one year before the filing of the subsequent claim. It 
also prohibits any award of benefits for a period of time covered by 
that prior denial. Responsible operators have argued to the circuit 
courts of appeals that the Department's regulatory scheme allows the 
``recycling'' of an old claim in violation of the Supreme Court's 
holding that a black lung claimant may not ``seek[] to avoid the bar of 
res judicata [finality] on the ground that the decision was wrong.'' 
Pittston Coal Group v. Sebben, 488 U.S. 105, 123 (1988). The courts 
have uniformly rejected this argument, see Lovilia Coal Co. v. Harvey, 
109 F.3d 445, 449-450 (8th Cir. 1997), cert. denied, 118 S. Ct. 1385 
(1998). Thus, the Department's proposal is fully consistent with the 
Supreme Court's holding in Sebben, and gives appropriate finality to 
prior denials.
    The Department's experience with subsequent claims also 
demonstrates the need for such filings. During the period between 
January 1, 1982, when the Black Lung Benefits Amendments of 1981 took 
effect, and July 16, 1998, 10.56 percent of the subsequent claims filed 
by living miners were ultimately awarded as opposed to only 7.47 
percent of first-time claims. To prevent a miner who has previously 
been denied benefits from filing a subsequent claim would force each 
miner to ``guess'' correctly when he has become totally disabled due to 
pneumoconiosis arising out of coal mine employment because a premature 
and unsuccessful filing would forever bar an award. In addition, the 
total number of subsequent claims filed by miners during that same time 
period, 30,964, as compared to the total number of claims filed, 
approximately 107,000, indicates that the provision is not abused. Of 
the total number of claims filed, only approximately 1,400, or 1.3 
percent, were from individuals who had been denied benefits three or 
more times. Thus, in general, only an individual who believes his 
condition has truly worsened files a subsequent claim.
    Although the Department's proposal would allow the filing of 
subsequent claims, the Department also intends to take steps to better 
educate claimants with respect to the requirements for entitlement. The 
Department intends to provide better initial pulmonary evaluations and 
better reasoned, more detailed explanations of denials of claims. By 
providing claimants with a more realistic view of their possible 
entitlement, the Department expects that the number of nonmeritorious 
applications will be reduced.
Attorneys' Fees
    In its first notice of proposed rulemaking, the Department 
attempted to clarify an operator's liability for a claimant's 
attorney's fees and the dates on which the operator's liability 
commenced. The Department also recognized the Trust Fund's liability 
for attorneys' fees and made it coextensive with a liable operator's. 
In general, the Department used the date of the event which created an 
adversarial relationship between the claimant and either the operator 
or the fund as the date on which liability for a claimant's attorney's 
fees commenced. The Department used this date based on the theory that 
it was the creation of an adversarial relationship which required 
employment of an attorney. Thus, for example, a successful claimant's 
attorney could only collect a fee from an operator or the fund for 
necessary work performed after the liable operator first contested the 
claimant's eligibility or the fund first denied the claim. See 62 FR 
3354, 3399 (Jan. 22, 1997).
    Upon further reflection and consideration of the comments received, 
however, the Department now proposes to allow successful claimants' 
attorneys to collect fees from an operator or the fund for all 
necessary work they perform in a case rather than only the work 
performed after creation of an adversarial relationship. Although the 
creation of an adversarial relationship and the ultimately successful 
prosecution of a claim are still necessary to trigger employer or fund 
liability for attorneys' fees, the date on which the adversarial 
relationship commenced will no longer serve as the starting point of 
liability. The Department believes this change may be appropriate in 
light of the evidentiary limitations present in the proposal. These 
limitations significantly alter the consequences of an early submission 
of evidence and make the quality of each piece of evidence submitted 
significantly more important. Thus, in an attempt to avoid setting a 
trap for the unwary claimant and to encourage early attorney 
involvement in these claims, the Department proposes allowing 
successful attorneys to collect fees for all of the necessary work they 
perform.
Treating Physicians' Opinions
    In the preamble accompanying its initial proposal, the Department 
noted that its proposal to allow a fact-finder to give controlling 
weight to the opinion of

[[Page 54969]]

a treating physician attempted to codify principles embodied in case 
law and also drew on a similar regulation adopted by the Social 
Security Administration, 20 CFR 404.1527(d)(2). See 62 Fed. Reg. 3338, 
3342 (Jan. 22, 1997). The Department's proposal elicited widely 
divergent comment from numerous sources. The Department now invites 
comment on alternative ways to determine when a treating physician's 
opinion may be entitled to controlling weight.
    The purpose of this proposal is not to limit a factfinder's 
consideration of any properly admitted medical or other relevant 
evidence. Rather, this regulation would mandate only that the 
factfinder recognize that a treating physician may possess additional 
insight into the miner's respiratory or pulmonary condition by virtue 
of his extended treatment. The Department has proposed two changes to 
Sec. 718.104(d). In the absence of contrary probative evidence, the 
adjudication officer would be required to accept the physician's 
statement with regard to the nature and duration of the doctor's 
treatment relationship with the miner, and the frequency and extent of 
that treatment. Sec. 718.104(d)(5). The Department has also added 
language to Sec. 718.104(d) to make explicit its intent that a treating 
physician's opinion may establish all of the medical elements of 
entitlement. Finally, the Department has retained the language in the 
original proposal that whether controlling weight is given to the 
opinion of a treating physician shall also be based on the credibility 
of that opinion in light of its reasoning and documentation, other 
relevant evidence and the record as a whole.
Waiver of Overpayments
    In its previous notice of proposed rulemaking, the Department 
extended the right to seek waiver of recovery of an overpayment to all 
claimants, without regard to whether recovery was sought by a 
responsible operator or the Black Lung Disability Trust Fund. 62 FR 
3366-3367 (Jan. 22, 1997). The Department received numerous comments in 
response, many urging adoption of a more generous waiver provision 
fashioned after the Longshore and Harbor Workers' Compensation Act. 
Many other comments opposed the extension of waiver rights to all 
claimants as an unconstitutional deprivation of responsible operators' 
property rights and right to appeal. Thus far, these comments have not 
provided the Department with a sufficient basis for altering its 
original proposal. See the discussion under Sec. 725.547.
    The Department also heard testimony from a number of witnesses 
generally critical of the application of the criteria used to determine 
whether recoupment of an overpayment would defeat the purposes of title 
IV of the Federal Coal Mine Health and Safety Act or would be against 
equity and good conscience. These waiver criteria are incorporated into 
the Black Lung Benefits Act from the Social Security Act, 30 U.S.C. 
923(b), 940, incorporating 42 U.S.C. 404(b), and the Social Security 
Administration uses them in its adjudication of overpayments arising 
under title II of the Social Security Act. Thus, Social Security's 
current interpretation of these criteria is found in Social Security 
regulations governing title II claims, 20 CFR 404.506 through 404.512, 
not in their regulations governing Part B claims filed under the Black 
Lung Benefits Act, 20 CFR 410.561 through 410.561h. In order to make 
the standards for waiver of recovery of a black lung overpayment more 
current, the Department proposes to amend section 725.543 to 
incorporate Social Security's title II standards, rather than its Part 
B regulations.
Definition of Pneumoconiosis and Establishing Total Disability Due to 
Pneumoconiosis
    The Department has suggested no further change to its initial 
proposal defining pneumoconiosis, Sec. 718.201, and no significant 
change to its regulation defining total disability and disability 
causation, Sec. 718.204. The miner retains the burden of proving each 
of these required elements of entitlement.
    The Department received widely divergent comments from medical 
professionals on its proposed definition of pneumoconiosis. Some 
commenters argued that the proposal lacked a sound medical basis and 
would therefore unjustifiably increase the number of claims approved. 
Other physicians, also with expertise in pulmonary medicine, supported 
the proposal. As a result, the Department sought additional guidance on 
this issue from the National Institute for Occupational Safety and 
Health (NIOSH). The Department forwarded to NIOSH all of the comments 
and testimony it had received relevant to Sec. 718.201 and requested 
that NIOSH advise the Department whether any of the material altered 
that agency's original opinion, submitted during the comment period, 
which supported the Department's proposal. NIOSH concluded that the 
unfavorable comments and testimony did not alter its previous position: 
NIOSH scientific analysis supports the proposed definitional changes.
    The Department also received numerous comments on its proposed 
regulation defining total disability and disability causation, and 
setting out the criteria for establishing total disability. The 
Department has proposed no significant change to Sec. 718.204. It has 
proposed, however, a change in the methodology by which pulmonary 
function tests are administered. Sec. 718.103(a) and Appendix B to Part 
718. This proposal would require that pulmonary function testing be 
administered by means of a flow-volume loop, a more reliable method of 
ensuring valid, verifiable results in pulmonary function testing. The 
Department invites comment on these proposed changes.
True Doubt
    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. In its first 
notice of proposed rulemaking, the Department proposed deleting 
subsection (c) of the current regulation at Sec. 718.3, because the 
Supreme Court held that this language failed to define the ``true 
doubt'' rule effectively. 62 FR 3341 (Jan. 22, 1997). Although the 
Department received a number of comments urging the proposal of a 
``true doubt'' rule, the Department has not done so in this second 
notice of proposed rulemaking.
    The Department believes that evaluation of conflicting medical 
evidence requires careful consideration of a wide variety of disparate 
factors, making the applicability of any true doubt rule extremely 
limited. The availability of these factors makes it unlikely that a 
factfinder will be able to conclude that the evidence, although in 
conflict, is equally probative. Thus, the Department does not believe 
that promulgation of a true doubt rule will enhance decision-making 
under the Act.
Federal Coal Mine Health and Safety Act Endorsement
    Section 726.203 was not among the regulations the Department opened 
for comment in its previous notice of proposed rulemaking. 
Representatives of the insurance industry commented, however, that a 
different version of the endorsement contained in Sec. 726.203(a) has 
been in use since 1984, with the Department's knowledge and consent. 
The Department is now opening Sec. 726.203 for comment. Although this 
proposal does not suggest alternative language for the endorsement, the

[[Page 54970]]

preamble does contain the version of the endorsement which the industry 
provided. The Department invites comment on its possible use, but urges 
commenters to bear in mind the requirement in Sec. 726.205 that 
endorsements other than those provided by Sec. 726.203 may be used only 
if they do not ``materially alter or attempt [] to alter an operator's 
liability for the payment of any benefits under the Act.* * *'' The 
Department also requests that the insurance industry submit for the 
record any document it might possess from the Department authorizing 
use of the different endorsement.
Medical Benefits
    Since the Department's initial proposal, the U.S. Court of Appeals 
for the Sixth Circuit has issued a decision addressing the 
compensability of medical expenses incurred as a result of treatment 
for totally disabling pneumoconiosis. Glen Coal Co. v. Seals, 147 F.3d 
502 (6th Cir. 1998). A majority of that panel held that the Benefits 
Review Board had erred by applying the Fourth Circuit's presumption to 
a miner whose coal mine employment took place within the jurisdiction 
of the Sixth Circuit. In the Fourth Circuit, if a miner entitled to 
monthly black lung benefits receives treatment for a pulmonary 
disorder, it is presumed that that disorder is caused or aggravated by 
the miner's pneumoconiosis. Doris Coal Co. v. Director, OWCP, 938 F.2d 
492 (4th Cir. 1991); Gulf & Western Indus. v. Ling, __ F.3d __, 1999 WL 
148851 (4th Cir. Mar. 19, 1999).
    The Department believes that black lung benefit claims adjudication 
should vary as little as possible from circuit to circuit, and 
consequently continues to propose a regulatory presumption, based on 
the Fourth Circuit's approach, that would apply nationwide. The Sixth 
Circuit's opinion would allow such a result, given the separate views 
expressed by each of the three judges sitting on that panel. The 
Department also believes that a regulatory presumption governing the 
compensability of medical expenses for the treatment of totally 
disabling pneumoconiosis is appropriate given the rational connection 
between the facts proven and the facts presumed.

Explanation of Proposed Changes

Open Regulations

    The Department invites comments from interested parties on 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, 
Sec. 718.307, Sec. 718.401, Sec. 718.402, Sec. 718.403, Sec. 718.404, 
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, Sec. 725.608, Sec. 725.609, 
Sec. 725.620, Sec. 725.621, Sec. 725.701, Sec. 725.706, Sec. 726.2, 
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. 726.203, 
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, 
Sec. 726.320, and part 727 (entire).
New Regulations Open for Comment
    The Department's initial notice of proposed rulemaking contained a 
list of regulations, entitled ``Substantive Revisions,'' that the 
Department proposed to revise. 62 FR at 3340 (Jan. 22, 1997). That list 
of regulations is reproduced above with six additions. The Department 
is now proposing changes to ten regulations that were not open for 
comment previously: Sec. 725.351, Sec. 725.403, Sec. 725.465, 
Sec. 725.515, Sec. 725.533, Sec. 725.543, Sec. 725.544, Sec. 725.548, 
Sec. 726.3, and Sec. 726.203. Although the Department has not proposed 
any specific changes to section 726.203, the Department seeks comment 
from interested parties on the changes to that regulation suggested by 
the insurance industry. Accordingly, the Department now invites comment 
from all interested parties on the regulations listed above as Open 
Regulations.
Additional Technical changes
    The Department's first proposal identified a number of regulations 
to which the Department was proposing to make technical revisions. See 
62 FR 3340-41 (Jan. 22, 1997). The Department is now proposing 
additional technical revisions. Among other things, these proposed 
changes delete references to the control numbers used by the Office of 
Management and Budget to approve revisions to the regulations in 1984 
because the inclusion of these numbers is neither necessary nor helpful 
to understanding the Department's regulations. See, e.g., 20 CFR 
718.102 (1999). In addition, at the request of the Office of the 
Federal Register, the Department is proposing to change references to 
various components of title 20 of the Code of Federal Regulations and 
to various statutory provisions and to add a colon to Sec. 726.1. The 
following regulations should be added to the list of regulations to 
which the Department is making only technical revisions: Appendix A to 
Part 718, Sec. 725.201, Sec. 725.218, Sec. 725.220, Sec. 725.531, 
Sec. 725.536, Sec. 726.1, Sec. 726.103, Sec. 726.207, Sec. 726.208, 
Sec. 726.209, Sec. 726.210, Sec. 726.211, Sec. 726.212, and 
Sec. 726.213.
Complete List of Technical Revisions
    The complete list of regulations to which the Department is making 
technical changes is as follows: Sec. 718.1, Sec. 718.2, Sec. 718.4, 
Sec. 718.303, Appendix A to Part 718, Sec. 725.102, Sec. 725.201, 
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. 725.453A, Sec. 725.455, Sec. 725.459A, Sec. 725.462, 
Sec. 725.463, Sec. 725.466, Sec. 725.480, Sec. 725.496, Sec. 725.501, 
Sec. 725.503A, 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. 725.603, Sec. 725.604, Sec. 725.605, 
Sec. 725.607, Sec. 725.701A, 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. 726.207, Sec. 726.208, Sec. 726.209, 
Sec. 726.210, Sec. 726.211, Sec. 726.212, and Sec. 726.213. Pursuant to 
the authority set forth in 5 U.S.C. 552(b)(3)(A), which allows federal 
agencies to alter ``rules of agency organization, procedure, or 
practice'' without notice and comment, the Department is not accepting 
comments on any of these regulations.

Unchanged Regulations

    Certain regulations are merely being re-promulgated without 
alteration and are also not open for public comment. To the extent 
appropriate, the Department's previous explanations of

[[Page 54971]]

these regulations, set forth in the Federal Register, see 43 FR 36772-
36831, Aug. 18, 1978; 48 FR 24272-24294, May 31, 1983, remain 
applicable. The same is true of those regulations to which the 
Department is making only technical changes. The following regulations 
are being re-promulgated for the convenience and readers: Sec. 718.203, 
Sec. 718.206, Sec. 718.302, Sec. 718.304, Sec. 718.305, Sec. 718.306, 
Sec. 725.3, Sec. 725.205, Sec. 725.206, Sec. 725.207, 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. 725.497, Sec. 725.511, 
Sec. 725.512, Sec. 725.520, Sec. 725.534, Sec. 725.535, Sec. 725.538, 
Sec. 725.539, Sec. 725.540, Sec. 725.541, Sec. 725.542, Sec. 725.545, 
Sec. 725.546, Sec. 725.601, 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.
Changes in the Department's Second Proposal
    The Department's second proposal contains substantive changes, 
either in the regulation or the preamble language, or both, to the 
following regulations: Sec. 718.3, Sec. 718.101, Sec. 718.103, 
Sec. 718.104, Sec. 718.105, Sec. 718.106, Sec. 718.107, Sec. 718.201, 
Sec. 718.204, Sec. 718.205, Part 718, Appendix B, Sec. 725.2, 
Sec. 725.101, Sec. 725.209, Sec. 725.223, Sec. 725.309, Sec. 725.310, 
Sec. 725.351, Sec. 725.367, Sec. 725.403, Sec. 725.406, Sec. 725.407, 
Sec. 725.408, Sec. 725.409, Sec. 725.411, Sec. 725.414, Sec. 725.416, 
Sec. 725.456, Sec. 725.457, Sec. 725.459, Sec. 725.465, 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. 725.533, Sec. 725.543, Sec. 725.544, 
Sec. 725.547, Sec. 725.548, Sec. 725.606, Sec. 725.701, Sec. 726.3, 
Sec. 726.8 and Sec. 726.203. The Department has carefully considered 
all of the comments that it has received to date with regard to the 
regulations. The preamble contains an explanation of the Department's 
proposed changes as well as its reason for rejecting other suggestions.
    In particular, the Department invites comment from small businesses 
that may not have been aware of the potential impact of the 
Department's proposed rule. In order to ensure that small businesses 
have adequate information, the Department intends to mail a copy of 
this proposal to each coal mine operator who is identified in current 
records maintained by the Mine Safety and Health Administration.
    Several commenters suggest that the Department lacks the authority 
to revise the regulations governing claims filed under the Black Lung 
Benefits Act. Although some of these objections are limited to 
individual regulations, such as the definition of ``pneumoconiosis,'' 
and will be addressed in the discussion of those regulations, two of 
the objections apply to a substantial number of the revisions made by 
the Department. They are: first, that the Department lacks the 
authority to promulgate regulations covering matters that were the 
subject of an unsuccessful attempt to amend the Act in 1994; and, 
second, that the Supreme Court's decision in Director, OWCP v. 
Greenwich Collieries, 512 U.S. 267 (1994), prohibits the Department 
from adopting any regulation that requires coal mine operators to bear 
a burden of proof.
Regulatory Authority
    In 1994, the 104th Congress considered legislation that would have 
amended the Black Lung Benefits Act by, among other things, limiting 
the amount of evidence parties may submit, providing claimants with 
overpayment relief, and allowing previously denied applicants to seek 
de novo review of their claims. The House passed a version of this 
legislation, H.R. 2108, on May 19, 1994, but the Senate adjourned in 
September, 1994 without acting on several similar bills. Numerous 
commenters have argued that in ``rejecting'' H.R. 2108, the Congress 
has already disapproved certain of the revisions now proposed by the 
Department. This argument fails on two grounds. First, Congress' 
failure to act does not deprive the Department of the authority to 
promulgate regulations otherwise conferred by the Black Lung Benefits 
Act. Second, Congress did not reject the legislation. Instead, the 
Senate adjourned without considering its version of the bill passed by 
the House.
    The starting point for determining the validity of any regulation 
is the legislation authorizing the agency to issue binding rules. As a 
general matter, ``[t]he power of an administrative agency to administer 
a congressionally created * * * program necessarily requires the 
formulation of policy and the making of rules to fill any gap left, 
implicitly or explicitly, by Congress.'' Morton v. Ruiz, 415 U.S. 199, 
231 (1974). ``If Congress has explicitly left a gap for the agency to 
fill, there is an express delegation of authority to the agency to 
elucidate a specific provision of the statute by regulation. Such 
legislative regulations are given controlling weight unless they are 
arbitrary, capricious, or manifestly contrary to the statute.'' Chevron 
v. Natural Resources Defense Council, 467 U.S. 837, 843-44 (1984).
    In Pauley v. Bethenergy Mines, Inc., 501 U.S. 680 (1991), the 
Supreme Court recognized the applicability of the Chevron analysis to 
regulations implementing the Black Lung Benefits Act:

    It is precisely this recognition that informs our determination 
that deference to the Secretary is appropriate here. The Black Lung 
Benefits Act has produced a complex and highly technical regulatory 
program. The identification and classification of medical 
eligibility criteria necessarily require significant expertise, and 
entail the exercise of judgment grounded in policy concerns. In 
those circumstances, courts appropriately defer to the agency 
entrusted by Congress to make such policy determinations.

Id. at 696. In addition to providing this general authority, the Black 
Lung Benefits Act contains several explicit provisions authorizing 
rule-making by the Department of Labor. Section 422(a) of the Act 
provides that ``[i]n administering this part [Part C of the Act], the 
Secretary is authorized to prescribe in the Federal Register such 
additional provisions * * * as [s]he deems necessary to provide for the 
payment of benefits by such operator to persons entitled thereto as 
provided in this part and thereafter those provisions shall be 
applicable to such operator.'' 30 U.S.C. 932(a). Section 426(a) of the 
Act similarly authorizes the Secretary to ``issue such regulations as 
[she] deems appropriate to carry out the provisions of this title.'' 30 
U.S.C. 936(a). As the Fourth Circuit has pointed out, these two 
provisions represent a ``broad grant of rulemaking authority.'' Harman 
Mining Co. v. Director, OWCP, 826 F.2d 1388, 1390 (4th Cir. 1987). 
Finally, the Act contains several other provisions authorizing the 
Secretary to promulgate regulations on specific subjects. See, e.g., 30 
U.S.C. 902(f)(1)(D) (criteria for medical tests which accurately 
reflect total disability), 932(h) (standards for assigning liability to 
operators), and 933(b)(3) (required insurance contract provisions).
    The Secretary's rulemaking authority is not unlimited. For example, 
section 422(a) prohibits the Department from promulgating regulations 
that are inconsistent with Congress's decision to exclude certain 
provisions of the Longshore and Harbor Workers' Compensation Act from 
those

[[Page 54972]]

incorporated into the Black Lung Benefits Act. Moreover, under Chevron, 
the Department clearly has no authority to issue regulations on a 
subject which Congress has addressed unambiguously. Pittston Coal Group 
v. Sebben, 488 U.S. 105 (1988). For example, in 1981, Congress amended 
the Act to limit the eligibility of surviving spouses of deceased coal 
miners who filed claims on or after January 1, 1982. Congress provided 
that such a spouse would be entitled to survivors' benefits only if 
[s]he could establish that the miner had died due to pneumoconiosis. 
Pub. L. 97-119, 95 Stat. 1635, Sec. 203(a)(2), (3). The bill passed by 
the House in 1994 would have reinstated so-called unrelated death 
benefits so as to allow a surviving spouse to collect benefits, no 
matter the miner's cause of death, so long as the miner was totally 
disabled due to pneumoconiosis at the time of death. Because that bill 
did not become law, however, the 1981 requirement remains in effect, 
and quite obviously limits the Department's ability to regulate in this 
area.
    The mere fact that Congress considered legislation affecting some 
of the same subjects addressed by the Department's regulatory proposal, 
however, cannot be construed as a similar limitation. ``Ordinarily, and 
quite appropriately, courts are slow to attribute significance to the 
failure of Congress to act on particular legislation.'' Bob Jones 
University v. United States, 461 U.S. 574, 600 (1983). In particular, 
the Department is not aware of any case holding that the failure of a 
previous Congress to enact legislation prevents an administrative 
agency from promulgating regulations on similar topics.
    Moreover, the regulations proposed by the Department are, for the 
most part, quite different in content from the provisions of either the 
bill that was passed by the House or the bills that were under 
consideration by the Senate when it adjourned. The Department's 
proposed revision of the definition of ``pneumoconiosis'' is similar in 
one respect to a provision in H.R. 2108 (recognizing that both 
obstructive and restrictive lung disease may be caused by exposure to 
coal mine dust). Other provisions, however, are significantly 
different. For example, H.R. 2108 would have completely relieved 
claimants of the obligation to repay overpaid amounts. In contrast, the 
Department's proposal would ensure only that the rules governing waiver 
of overpayments are applied without regard to whether the overpayment 
was made by the Black Lung Disability Trust Fund or a responsible 
operator. In fact, the Department has specifically rejected comments 
urging it to use certain provisions incorporated from the Longshore and 
Harbor Workers' Compensation Act that would bar the recoupment of 
overpayments by employers, an approach similar to that considered by 
the 104th Congress. Although the Department is not proposing the 
widespread overpayment relief that was contained in H.R. 2108 and was 
sought by these commenters, the Department also does not believe that 
Congress intended that claimants who receive payment from the Trust 
Fund be treated differently than claimants who receive payments from 
liable coal mine operators. The Department's proposal would simply 
guarantee the equitable treatment of both claimant groups.
    The Department's proposed evidentiary limitation is also 
significantly different from the limitation set forth in H.R. 2108. 
Under the bill passed by the House, claimants would have been allowed 
to submit three medical opinions, and responsible operators or the 
Trust Fund would have been allowed only one. The Department agrees that 
evidentiary limitations are needed to level the playing field between 
operators and claimants, but does not believe that the playing field 
should be tilted in favor of one party. Rather, the Department's 
proposal treats all parties equally and encourages them to rely on the 
quality of their medical evidence rather than its quantity. Hopefully, 
the proposal's evidentiary limitations will improve the decisionmaking 
process in black lung benefit claims.
    Finally, the Department's treatment of denied claims also differs 
significantly from that proposed in the legislation. H.R. 2108 would 
have allowed any claimant denied benefits based on a claim filed on or 
after January 1, 1982 to seek readjudication of that claim without 
regard to the previous denial. The Department's proposed revision of 
Sec. 725.309, on the other hand, specifically forbids the parties from 
seeking readjudication of the earlier denial of benefits. 
Sec. 725.309(d). Instead, the Department has proposed the codification 
of a solution that has already been accepted by five courts of appeals 
with jurisdiction over more than 90 percent of black lung claims filed. 
That solution requires a claimant to establish, with new evidence, at 
least one of the elements previously resolved against him before a new 
claim may even be considered on the merits. Even if a claimant 
establishes his entitlement to benefits based on a subsequent claim, 
benefits will be paid based only on that application and not for time 
periods covered by the earlier, final denial.
    The Department therefore cannot accept the argument that Congress' 
failure to enact legislation in 1994 prevents the Department from 
revising regulations that have not been amended since 1983. In many 
cases, the Department is simply proposing to codify the decisions of a 
majority of the appellate courts. In other cases, the Department's 
proposed revisions represent reasonable methods of dealing with 
problems that have arisen since the black lung benefits regulations 
were first promulgated in 1978. The Department's ability to address 
those problems in regulations is independent of any Congressional 
effort to reform the Black Lung Benefits Act, and should be judged 
according to the standards set forth in Chevron. For the reasons set 
forth in its initial notice of proposed rulemaking, 62 FR 3337 (Jan. 
22, 1997) and in this notice, the Department believes that its proposed 
revisions meet those standards.
Administrative Procedure Act
    A number of commenters also suggest that the Department's ability 
to create regulatory presumptions is constrained by the Administrative 
Procedure Act and the Supreme Court's decision in Greenwich Collieries. 
In Greenwich Collieries, the Supreme Court invalidated the use of the 
``true doubt'' rule, an evidentiary principle that effectively shifted 
the risk of non-persuasion from black lung applicants to coal mine 
operators. Under the ``true doubt'' rule, fact-finders were required to 
resolve any issue in favor of the claimant if the evidence for and 
against entitlement was equally probative. In contrast, section 7(c) of 
the Administrative Procedure Act (APA), 5 U.S.C. 556(d), states that 
``[e]xcept as otherwise provided by statute, the proponent of a rule or 
order has the burden of proof.'' The Court held that, even assuming 
that the Department could displace the APA through regulation, the 
Department's existing regulation, 20 CFR 718.403, was insufficient to 
do so. Finally, the Court determined that the party assigned the 
``burden of proof'' by the APA bore the risk of non-persuasion. As a 
result, the court held the APA required that the Department resolve 
cases of equally probative evidence against the claimant, the party 
seeking an order compelling the payment of benefits.
    The commenters argue that the Court's decision effectively 
prohibits the Department from imposing any burden of proof on an 
operator under the Black Lung Benefits Act. The Department does

[[Page 54973]]

not believe that Greenwich Collieries requires such a result. At the 
outset, it should be clear that the Court's decision did not address 
the relationship between the Department's rulemaking authority and the 
APA. Section 956 of the Federal Mine Safety and Health Act (FMSHA) 
provides as follows:

    Except as otherwise provided in this chapter, the provisions of 
sections 551 to 559 and sections 701 to 706 of Title 5 shall not 
apply to the making of any order, notice, or decision made pursuant 
to this chapter, or to any proceeding for the review thereof.

30 U.S.C. 956. ``This chapter'' is a reference to chapter 22 of Title 
30, United States Code, which codifies the FMSHA. Because the Black 
Lung Benefits Act is subchapter IV of the FMSHA, section 956 generally 
exempts the Act from the requirements of the section 7(c) of the APA. 
Similarly, although section 19 of the Longshore and Harbor Workers' 
Compensation Act, 33 U.S.C. 919, incorporated into the BLBA by 30 
U.S.C. 932(a), makes the APA applicable to the adjudication of claims 
under the LHWCA, that provision is incorporated into the Black Lung 
Benefits Act only ``except as otherwise provided * * * by regulations 
of the Secretary.'' The clear language of the FMSHA and the BLBA thus 
authorize the Secretary to depart from the dictates of section 7(c) 
when she determines it is in the best interest of the black lung 
benefits program.
    Moreover, the Court's decision in Greenwich Collieries did not 
purport to decide the issues on which a particular party bears the 
burden of persuasion. Rather, the Court merely decided that with 
respect to two issues on which the claimant bears the burden of proof 
under the Secretary's existing regulations (the existence of 
pneumoconiosis and the cause of that disease), the claimant must 
prevail by a preponderance of the evidence. As the Court observed in 
its subsequent decision in Metropolitan Stevedore Co. v. Rambo, 117 S. 
Ct. 1953, 1963 (1997), ``the preponderance standard goes to how 
convincing the evidence in favor of a fact must be in comparison with 
the evidence against it before that fact may be found, but does not 
determine what facts must be proven as a substantive part of a claim or 
defense.''
    Under Greenwich Collieries, then, the Department remains free to 
assign burdens of proof to parties as necessary to accomplish the 
purposes of the Black Lung Benefits Act. The Department has 
historically used regulatory presumptions where they were appropriate. 
For example, current 20 CFR 725.492(c), presumes that each employee of 
a coal mine operator was regularly and continuously exposed to coal 
dust during the course of his employment. In promulgating this 
regulation, the Department noted that such a showing required evidence 
that was not generally available to the Department; rather such 
evidence was within the control of the employer. 43 FR 36802-03 (Aug. 
18, 1978). Current 20 CFR 725.493(a)(6) presumes that a miner's 
pneumoconiosis arose in whole or in part out of employment with the 
employer that meets the conditions for designation as the responsible 
operator. Unless the presumption is rebutted, the regulation requires 
the responsible operator to pay benefits to the claimant on account of 
the miner's total disability or death. One commenter objected to this 
presumption, set forth in revised Sec. 725.494(a), as a violation of 
Greenwich Collieries, notwithstanding the Act's specific provision 
authorizing the use of presumptions with respect to assignment of 
liability to a miner's former employers. 30 U.S.C. 932(h).
    Even where the BLBA is silent, the Act grants the Secretary 
sufficiently broad rulemaking authority to authorize the adoption of 
other presumptions. In American Hospital Association v. NLRB, 499 U.S. 
606 (1991), the Court considered the ability of the National Labor 
Relations Board, using similarly broad regulatory authority, to define 
an appropriate bargaining unit by rulemaking even though the statute 
required the Board to decide the appropriate bargaining unit ``in each 
case.'' Citing a series of previous decisions, the Court held that 
``even if a statutory scheme requires individualized determinations, 
the decisionmaker has the authority to rely on rulemaking to resolve 
certain issues of general applicability unless Congress clearly 
expresses an intent to withhold that authority.'' Id. at 612. The Court 
expanded on the NLRB's rulemaking authority in Allentown Mack Sales and 
Service, Inc. v. NLRB, 118 S. Ct. 818 (1998). In dicta, the Court 
concluded as follows:

    The Board can, of course, forthrightly and explicitly adopt 
counterfactual evidentiary presumptions (which are in effect 
substantive rules of law) as a way of furthering legal or policy 
goals--for example, the Board's irrebuttable presumption of majority 
support for the union during the year following certification, see, 
e.g., Station KKHI, 284 N.L.R.B. 1339, 1340, 1987 WL 89811 (1987), 
enf'd, 891 F.2d 230 (C.A.9 1989). The Board might also be justified 
in forthrightly and explicitly adopting a rule of evidence that 
categorically excludes certain testimony on policy grounds, without 
regard to its inherent probative value. (Such clearly announced 
rules of law or of evidentiary exclusion would of course by subject 
to judicial review for their reasonableness and their compatibility 
with the Act.)

Id. at 828.
    The NLRB's rulemaking authority in this regard is not unique. The 
federal courts have upheld the use of presumptions by agencies as 
diverse as the Department of Transportation, see Chemical Manufacturers 
Association v. Department of Transportation, 105 F.3d 702, 705 (D.C. 
Cir. 1997) (``It is well settled that an administrative agency may 
establish evidentiary presumptions''); the Interstate Commerce 
Commission, see Western Resources, Inc. v. Surface Transportation 
Board, 109 F.3d 782, 788 (D.C. Cir. 1997); the Nuclear Regulatory 
Commission, see New England Coalition on Nuclear Pollution v. NRC, 727 
F.2d 1127, 1129 (D.C.Cir.1984) (Scalia, J.) (even a statutory mandate 
requiring consideration of a specific issue ``does not preclude the 
adoption of appropriate generalized criteria that would render some 
case-by-case evaluations unnecessary''); and the Department of 
Education, see Atlanta College of Medical and Dental Careers, Inc. v. 
Riley, 987 F.2d 821, 830 (D.C. Cir. 1993) (``* * * under the 
circumstances, it would seem quite reasonable for the Secretary to 
adopt regulations or even adjudicatory presumptions--bright-line 
rules--as to what a school must show * * *''). To the extent that the 
Department, like any other administrative agency, uses rulemaking to 
establish a presumption, that presumption must be based on a rational 
nexus between the proven facts and the presumed facts. Chemical 
Manufacturers Association, 105 F.3d at 705; NLRB v. Baptist Hosp., 
Inc., 442 U.S. 773, 787 (1979).
    The Department's proposed regulations include provisions that 
adjust burdens of proof among the parties. Section 725.495(c)(2), for 
example, provides that the potentially liable operator designated as 
the responsible operator by the Office of Workers' Compensation 
Programs bears the burden of establishing that another operator that 
employed the miner more recently is financially capable of assuming 
liability for the payment of benefits. Section 726.312 specifically 
allocates various burdens of proof between the Department and a coal 
mine operator against which the Department is seeking a civil money 
penalty for failure to secure the payment of benefits.
    In its initial notice of proposed rulemaking, 62 FR 3337 (Jan. 22, 
1997) and in this notice, the Department has demonstrated that such 
assignments of

[[Page 54974]]

burdens of proof have been carefully tailored to meet the specific 
needs of the black lung benefits program. Accordingly, the Department 
does not agree with those commenters who argue that the Supreme Court's 
decision in Greenwich Collieries prohibits the Department from 
requiring responsible operators and their insurers to meet any burden 
of proof in adjudications under the Act.

20 CFR Part 718--Standards for Determining Coal Miners' Total 
Disability or Death Due to Pneumoconiosis

Subpart A--General

20 CFR 718.3
    (a) In its earlier proposal, the Department proposed to delete 
subsection (c) of Sec. 718.3, which the Department had cited to the 
Supreme Court in support of its argument in favor of a ``true doubt'' 
rule. Under the ``true doubt'' rule, an evidentiary issue was resolved 
in favor of the claimant if the probative evidence for and against the 
claimant was in equipoise. In Director, OWCP v. Greenwich Collieries, 
512 U.S. 267 (1994), the Court held that an administrative law judge's 
use of the rule violated the Administrative Procedure Act, and that 
Sec. 718.3 was an ambiguous regulation that could not be read as 
authorizing such a rule.
    A number of commenters argue that the Supreme Court held any ``true 
doubt'' rule improper. Other comments urge the Department to reinstate 
the ``true doubt'' rule by promulgating a regulation that clearly 
authorizes fact-finders to use the rule in evaluating evidence in black 
lung benefits claims. Throughout this rulemaking, however, the 
Department has consistently stressed the need for factfinders to 
conduct in-depth analyses of the evidence based on its quality rather 
than quantity. Moreover, opinions by the courts of appeals and the 
Benefits Review Board over the past twenty years have firmly 
established that the evaluation of conflicting medical evidence 
includes consideration of a wide variety of disparate factors, thus 
making the applicability of any true doubt rule extremely limited. In 
the case of a medical report, for example, the factfinder must examine 
the report's documentation, its reasoning, its relationship to the 
other medical reports of record, and the physician's qualifications or 
other special status. The availability of all of these factors makes it 
unlikely that a factfinder will be able to conclude that the evidence, 
although in conflict, is equally probative. Accordingly, the Department 
does not believe that the promulgation of a revised ``true doubt'' rule 
will enhance decision-making under the Black Lung Benefits Act.
    (b) Several comments urge the Department to retain subsection (c) 
of the current version of Sec. 718.3. They argue that even if the 
language does not explicitly provide a ``true doubt'' rule, it is a 
useful reminder to factfinders of the purposes of the Black Lung 
Benefits Act. In particular, they point to the Department's quality 
standards for medical evidence and issues in which medical science does 
not provide a definitive answer. The Department recognizes that the 
adjudication of black lung benefits claims requires recognition of the 
difficulties faced by claimants in establishing their entitlement to 
benefits. Revised Sec. 718.101, for example, will require ``substantial 
compliance'' with all of the quality standards applicable to medical 
evidence, rather than strict adherence. Requiring ``substantial 
compliance'' with the quality standards will give the fact-finder 
sufficient flexibility to determine whether a particular piece of 
evidence is probative of the claimant's condition notwithstanding its 
failure to meet a relatively minor quality standard provision. The 
Department does not agree, however, that section 718.3 should contain a 
separate, and wholly unenforceable, statement of general principles. 
Subsection (c) simply restates Congressional intent reflected in the 
legislative history of the 1972 and 1978 amendments to the Black Lung 
Benefits Act, see S. Rep. No. 743, 92nd Cong., 2nd Sess. 11, 1972 
U.S.C.C.A.N. 2305; S. Rep. No. 95-209, 95th Cong., 2nd Sess. 13, 1978 
U.S.C.C.A.N. 237. That legislative history may be used to support a 
party's argument regardless of whether it is repeated in the 
Secretary's regulations.

Subpart B

20 CFR 718.101
    (a) The Department's proposed revision is intended to make clear 
its disagreement with Benefits Review Board case law holding that the 
Department's quality standards are applicable only to evidence 
developed by the Director, OWCP. See Gorzalka v. Big Horn Coal Co., 16 
Black Lung Rep. 1-48, 1-51 (Ben. Rev. Bd. 1990). Accordingly, the 
Department proposed to amend the regulations to ensure that all 
evidence developed in connection with black lung benefits claims meets 
certain minimal quality standards. One comment observes that, as 
drafted, the Department's revisions would allow factfinders to 
invalidate medical evidence in claims already pending before the 
Department although that evidence was valid under Board precedent when 
it was developed. The Department agrees that upsetting settled 
expectations regarding the applicability of the quality standards may 
work a substantial hardship in some cases, particularly those involving 
unrepresented claimants. Consequently, the Department has revised the 
language in section 718.101(b) to clarify that the mandatory nature and 
general applicability of the quality standards is prospective only. 
Once a final rule takes effect, any testing or examination conducted 
thereafter in connection with a black lung benefits claim that does not 
substantially comply with the applicable quality standard will be 
insufficient to establish the fact for which it is proffered.
    (b) Four comments oppose the general requirement in Sec. 718.101(b) 
that all evidence developed by any party in conjunction with a claim 
for black lung benefits must be in substantial compliance with the 
quality standards contained in subpart B. One comment notes the special 
hardship imposed on miners in trying to generate conforming evidence. 
Three comments assert that exclusion of nonconforming evidence violates 
the statutory mandate that ``all relevant evidence'' be considered in 
determining whether a claimant is entitled to benefits. 30 U.S.C. 
923(b). The Department disagrees. The quality standards have been an 
integral part of claims development and adjudication since the Part 718 
regulations were first promulgated in 1980. The Department has also 
consistently taken the position that the standards apply to all 
evidence developed by any party for purposes of prosecuting, or 
defending against, a claim for benefits. The proposed change simply 
makes this position clear. Finally, employing quality standards to 
ensure the use of reliable and technically accurate evidence is 
consistent with section 923(b). Evidence which fails the ``substantial 
compliance'' standard is inherently unreliable and thus necessarily 
inadequate to prove or disprove entitlement issues, and therefore is 
not ``relevant'' to the adjudication of the claim.
    (c) One comment asks that the Department clarify that the quality 
standards represent the only basis on which the reliability of a 
medical opinion or test may be challenged. As an example, the comment 
states that physicians cite the correlation between the one-second 
Forced Expiratory Volume and the Maximum Voluntary Ventilation as a 
basis for invalidating a

[[Page 54975]]

pulmonary function test, even though the MVV is not a required part of 
the test. In the Department's view, the quality standards provide 
factfinders with flexibility in their examination of the medical 
evidence of record. If an alleged flaw in medical evidence is not 
relevant to the necessary test results, the factfinder may properly 
ignore that flaw. The Department's quality standards, however, are not 
intended to serve as the sole basis upon which medical evidence may be 
evaluated. Instead, parties are free to develop any evidence that 
pertains to the validity of the medical evidence in order to provide 
the factfinder with the best evidence upon which to base a finding 
regarding the miner's physical condition.
    (d) Two comments are concerned that the quality standards could 
result in the exclusion of a miner's hospitalization and/or medical 
treatment records, or a report of biopsy or autopsy. Section 718.101, 
however, makes the quality standards applicable only to evidence 
``developed * * * in connection with a claim for benefits'' governed by 
20 CFR Parts 725 and 727. Therefore, the quality standards are 
inapplicable to evidence, such as hospitalization reports or treatment 
records, that is not developed for the purpose of establishing, or 
defeating, entitlement to black lung benefits.
    (e) One comment advocates permitting consideration of nonconforming 
tests which produce clinical results comparable to conforming tests. 
This suggestion is rejected for the reasons expressed in paragraph (b): 
failure to comply with the applicable quality standards deprives the 
evidence of its probative worth. Moreover, a nonconforming test which 
produces results similar to a conforming test does not significantly 
enhance the fact-finding process, given the availability of the 
technically accurate results.
    (f) One comment would require the Department to notify a party who 
submits nonconforming evidence, and afford an opportunity to 
rehabilitate the evidence. This requirement is unnecessary. Each party 
is responsible for developing evidence in support of its position which 
complies with the quality standards. Moreover, proposed Sec. 725.406 
does impose a duty on the district director to ensure that the medical 
examination sponsored by the Department is valid and conforming. If the 
district director identifies any deficiency in that examination, he 
must notify the physician and the miner, and take reasonable steps to 
correct that deficiency. Finally, evidence may be submitted up to 
twenty days before the formal hearing up to the limits provided in 
proposed Sec. 725.414. If the opposing party submits evidence in 
rebuttal, proposed Sec. 725.414 will permit the party that proffered 
the original evidence to attempt to rehabilitate evidence by submitting 
an additional report from the preparer of the original report.
    (g) Other comments oppose the use of quality standards in general 
terms. For the reasons expressed in the preamble to the proposed 
regulations, 62 FR 3341-42 (Jan. 22, 1997), the Department believes 
that such standards are necessary to ensure the development of reliable 
and technically accurate evidence for the adjudication of claims. 
Several comments express general support for requiring all parties to 
develop their medical evidence in conformance with the relevant quality 
standards.
20 CFR 718.103
    (a) One physician who testified at the Department's Washington, 
D.C. hearing objected to the proposal, set forth in Appendix B to Part 
718, that would have precluded miners undergoing pulmonary function 
testing from taking an initial inspiration from room air and instead 
would have required an initial inspiration from the spirometer. 
Transcript, Hearing on Proposed Changes to the Black Lung Program 
Regulations (July 22, 1997), p. 306 (testimony of Dr. David James). 
Under questioning by the Department's medical consultant, Dr. Leon 
Cander, Dr. James stated that use of the flow-volume loop would be more 
widely acceptable than the Department's proposal prohibiting an initial 
open-air inspiration. Transcript, pp. 319-320. After careful 
consideration, the Department agrees that the flow-volume loop may 
offer a more reliable method of ensuring valid, verifiable results in 
pulmonary function testing, and proposes to revise Sec. 718.103 in 
order to require that the flow-volume loop be used for every pulmonary 
function test administered to establish or defeat entitlement under the 
Black Lung Benefits Act. Spirometers capable of producing a flow-volume 
loop, and of electronically deriving a set of tracings showing volume 
versus time, are in use in a number of clinics and facilities 
specializing in the treatment of pulmonary conditions. While this 
notice of proposed rulemaking is open for public comment, the 
Department intends to conduct a survey of those clinics and facilities. 
Among the information the Department will seek is the extent to which 
they already use spirometers capable of producing flow-volume loops. 
The Department further notes that for clinics that do not already 
possess such a spirometer, the cost is less than $2,000. Because the 
use of flow-volume loops will increase the reliability of the pulmonary 
function study evidence submitted in black lung claims with only 
minimal cost, the Department proposes that all pulmonary function tests 
conducted after the effective date of the final rule be submitted in 
this form. Proposed changes have been made to subsections (a) and (b), 
as well as Appendix B, to accomplish this result. The Department 
invites comment on these changes.
    (b) Dr. James also observed that the language of subsection (a) is 
misleading in suggesting that pulmonary function testing may produce 
either a Forced Vital Capacity (FVC) or a Maximum Voluntary Ventilation 
(MVV) value. Transcript, Hearing on Proposed Changes to the Black Lung 
Program Regulations (July 22, 1997), pp. 304-5 (testimony of Dr. David 
James). Dr. James noted that a test must produce an FVC value in order 
to obtain a Forced Expiratory Volume for one second (FEV1), which is 
required by the regulation. The Department agrees, and has proposed 
revising subsection (a) accordingly.
    (c) The Department also proposes to revise subsection (b) in order 
to conform the regulation to the requirements of Appendix B. Currently, 
section 718.103(b) requires that three tracings of the MVV be performed 
unless the largest two values of the MVV are within 5 percent of each 
other. 20 CFR 718.103(b). Appendix B, however, provides that MVV 
results will be considered to have excessive variability if the two 
largest values vary by more than 10 percent. The Department proposes to 
adopt the 10 percent standard uniformly.
    (d) Two comments request the Department to amend section 718.103 to 
ensure that a miner's failure to produce a valid MVV value will not 
affect the validity of the FEV1 and FVC values. The Department agrees 
that the validity of the two tests should be assessed independently. 
The proposed change to subsection (a) will highlight the optional 
nature of the MVV test. Both comments also suggest that the failure of 
a test report to meet all of the requirements of subsection (b), such 
as the DOL claim number, should not wholly invalidate a test. Like 
other medical evidence, pulmonary function tests will be subject to the 
requirement of proposed Sec. 718.101 that they be in ``substantial 
compliance'' with the Department's quality standards. In a particular 
case, the parties remain free

[[Page 54976]]

to argue that a report's failure to meet certain technical requirements 
contained in the quality standards should not necessarily invalidate 
the report. The Department does not believe, however, that it would be 
appropriate to wholly remove these requirements from its quality 
standards.
    (e) One commenter observes that pulmonary function tests are not 
appropriate in all cases, noting that such testing may pose a danger to 
the health of some claimants. Section 718.103 does not affirmatively 
require the performance of pulmonary function tests, but merely sets 
forth the standards applicable to such studies, if performed. The 
Department agrees, however, that there may be cases in which 
performance of a pulmonary function test may be medically 
contraindicated. As a result, the Department has proposed revising 
Sec. 718.104(a)(6) to recognize that a medical report may not be 
excluded from consideration simply because the claimant's condition 
does not allow a physician to administer a pulmonary function test. The 
Department has also proposed reinstating language in 
Sec. 718.204(b)(2)(iv) that was inadvertently deleted from its initial 
proposal, 62 FR 3377 (Jan. 22, 1997).
20 CFR 718.104
    (a) One commenter objects to the requirement in subsection (a)(6) 
that all medical reports contain the results of pulmonary function 
testing. The commenter notes that in some cases, a miner may be 
physically unable to perform a pulmonary function test, or such a test 
may be medically contraindicated. The Department agrees, and has 
proposed revising subsection (a)(6) in order to recognize this 
possibility. When a miner cannot take a pulmonary function test, a 
physician writing a medical report must substantiate his conclusion(s) 
with other medically acceptable clinical and laboratory diagnostic 
techniques. This proposed addition merely recognizes the Department's 
longstanding position that pulmonary function tests may be medically 
contraindicated. The current regulation at 20 CFR 718.204(c)(4), which 
provides that a reasoned medical judgment may establish the presence of 
a totally disabling respiratory or pulmonary impairment, expressly 
recognizes that pulmonary function tests may be contraindicated. 
Similarly, the 1980 discussion accompanying promulgation of 20 CFR 
718.103 acknowledged the same point: ``If the physician believes that 
pulmonary function testing would impose a risk to the patient's well-
being, the physician should so state and refuse to have the patient 
perform the pulmonary function tests.'' 45 FR 13682 (Feb. 29, 1980).
    (b) Several commenters request that the regulation recognize that a 
treating physician's opinion may be used to establish all elements of a 
miner's entitlement to benefits. Although the proposed regulation was 
not intended to restrict the use of such a report, the Department has 
revised subsection (d) to explicitly list the elements of entitlement 
which a treating physician's opinion may establish.
    (c) Several commenters suggest that the Department accept a 
physician's statement as to the nature and duration of his relationship 
with the miner, and the frequency and extent of his treatment of the 
miner. The Department agrees that a claimant should not have to produce 
additional proof documenting these factors beyond that provided in the 
four corners of the physician's report unless the opposing party 
supplies credible evidence that demonstrates that the physician's 
statement is mistaken. The Department has therefore proposed an 
addition to subsection (d)(5) to make its intent clear.
    (d) Proposed paragraph (d), which would allow a fact-finder to give 
controlling weight to the opinion of a treating physician provided 
certain conditions are met, elicited a great deal of comment. Many 
commenters supported the proposal, noting that a treating physician has 
a greater familiarity with the miner's physical condition than a doctor 
who has only seen him once. Others opposed giving special credence to 
``small-town'' doctors without special expertise or training in 
respiratory or pulmonary disorders. Others simply expressed general 
opposition to the proposal. In the preamble accompanying its initial 
proposal, the Department explained that the proposed regulation 
attempted to codify existing case law and drew on a similar regulation 
adopted by the Social Security Administration, 20 CFR 404.1527(d)(2). 
See 62 FR 3338, 3342 (Jan. 22, 1997). The Department specifically 
invites comment on alternative methods for determining when a treating 
physician's opinion is entitled to controlling weight, including 
whether to adopt the Social Security Administration's rule.
    (e) Several commenters suggest that the proposed subsection (d)(5) 
is unnecessary and undermines any Departmental attempt to give a 
treating physician's opinion controlling weight. They request that the 
Department delete certain language in subsection (d)(5), which requires 
the factfinder to consider not only the treating physician's 
documentation and reasoning but also the other relevant evidence of 
record in determining whether the treating physician's opinion is 
entitled to controlling weight. These commenters would have the finder 
of fact credit a treating physician's opinion which meets the criteria 
in (d)(1)-(4) and is documented and reasoned without regard to the 
other relevant evidence of record. Another comment suggests that the 
Department has already accomplished this result, in violation of 
section 413(b) of the Act, 30 U.S.C. 923(b). The Department does not 
accept either suggestion. The purpose of the regulation is not to limit 
a factfinder's consideration of any properly admitted medical or other 
relevant evidence. Indeed, to do so might result in a mechanistic 
crediting of a treating physician's opinion which the courts have 
cautioned the Department to avoid. See Sterling Smokeless Coal Co. v. 
Akers, 131 F.3d 438, 441 (4th Cir. 1997); 62 FR at 3342 (Jan. 22, 
1997). Rather, the proposed regulation would mandate only that the 
factfinder recognize that a physician's long-term treatment of the 
miner may give that physician additional insight into the miner's 
respiratory or pulmonary condition.
    (f) Several commenters oppose any rule suggesting treating 
physicians' opinions may be given controlling weight. They argue that a 
factfinder's evaluation of a medical opinion should be based solely on 
the documentation and reasoning of that opinion as well as the 
qualifications of the physician. As the Department noted in its initial 
notice of proposed rulemaking, 62 FR 3342 (Jan. 22, 1997), special 
weight may be given a treating physician's opinion because that 
physician has been able to observe the miner over a period of time, and 
therefore may have a better understanding of the miner's physical 
condition. Although the factfinder must still evaluate the treating 
physician's report in light of all of the other relevant evidence of 
record, he should nevertheless be aware of the additional insight that 
a treating physician may bring to bear on the miner's respiratory or 
pulmonary condition.
    (g) Some commenters suggest that the ``treating physician'' rule 
should be removed from Sec. 718.104 and made a separate regulation. One 
suggests that its current placement appears to require that the 
treating physician's opinion must conform to the quality standards 
applicable to a report of physical examination. The Department intends 
that all reports of physical examination, including a report submitted 
by the

[[Page 54977]]

miner's treating physician, conform to the quality standards set forth 
in Sec. 718.104 if they are to be sufficient to establish or refute 
entitlement. The Department thus does not agree that subsection (d), 
governing treating physicians' opinions, should be made a separate 
regulation.
    (h) Several commenters state that the miner should be able to 
submit his treating physician's opinion without regard to the 
limitation on the amount of evidence each party would be able to submit 
under Sec. 725.414. These commenters argue that claimants, who are 
often unrepresented at the earliest stages of claims processing, will 
submit opinions from their treating physicians that do not conform to 
the Department's quality standards. The Department recognizes that the 
limitation on documentary medical evidence could have a substantial 
impact on unrepresented claimants who submit reports prematurely. 
Although the Department cannot agree to provide claimants with the 
opportunity to submit additional reports, the Department takes very 
seriously its obligation to inform all claimants of the evidentiary 
limitations in language that is clear and easily understood. In 
addition, as set forth in the proposed revision of Sec. 725.406, the 
Department intends to make the objective test results from each miner's 
section 413(b) pulmonary evaluation available to his treating physician 
at the miner's request. By providing these test results to the treating 
physician, the Department hopes to ensure that the ensuing opinion is 
as well documented as the other medical opinions of record and meets 
the Sec. 718.104 quality standard.
    (i) Several commenters argue that the terms ``treating physician'' 
and ``controlling weight'' are not defined. The intent of subsection 
(d), however, is not to create a strict rule to determine the outcome 
of a factfinder's evaluation of the medical evidence. Instead, the 
Department's goal is simply to require the factfinder to recognize the 
additional weight to which a physician's opinion may be entitled, in 
light of all of the other relevant evidence of record, where that 
physician has observed and treated the claimant over a period of time.
    (j) Several commenters object to certain language the Department 
used in the preamble of its initial notice of proposed rulemaking to 
explain its proposed revisions to Sec. 718.104. In the ``Summary of 
Noteworthy Proposed Changes,'' 62 FR 3339 (Jan. 22, 1997), the 
Department indicated that in evaluating a treating physician's opinion, 
a factfinder ``must'' consider, among other things, the physician's 
training and specialization. The Department did not intend to suggest 
that a factfinder's failure to consider such factors would necessarily 
represent reversible error. Only when a party raises the issue, for 
example, in the context of comparing the credentials of physicians 
offering contrary opinions, would the factfinder be required to 
consider such a factor. Moreover, even under such circumstances, a 
physician's training and specialization are only one factor for the 
factfinder to weigh in his evaluation of this evidence.
    (k) One commenter states that the quality standard applicable to 
medical reports should not require that the report include a chest X-
ray. The Department disagrees. A chest X-ray, administered and read in 
accordance with Sec. 718.102, is an important component of any 
evaluation for pneumoconiosis. Although a physician remains free to 
explain an opinion contrary to the medical testing that he conducted or 
reviewed, he must nevertheless have the benefit of that testing and 
account for its results. The requirement set forth in Sec. 718.101, 
that all evidence must be in ``substantial compliance'' with the 
applicable quality standards, affords all parties the opportunity to 
establish the reliability of any evidence notwithstanding its failure 
to strictly conform to the quality standards.
    (l) Two commenters request that the Department remove the clause 
from subsection (c) that limits the factfinder's use of non-conforming 
evidence in cases in which the miner is deceased and the physician is 
unavailable to clarify or correct his report. In such cases, the 
factfinder may consider a non-conforming medical report only if the 
record does not contain another conforming report. In this way, the 
Department hopes to ensure that entitlement determinations are based on 
the best quality medical evidence possible.
    (m) One comment requests that the Department include ``cardio-
pulmonary exercise testing'' as an ``other procedure[]'' under 
subsection (b). The Department does not intend that subsection (b) 
contain an exclusive list of medically acceptable procedures that may 
be used by a physician in the course of a physical examination. A 
physician is free to use any test, including cardio-pulmonary exercise 
testing, if he believes that it would aid in his evaluation of the 
miner.
20 CFR 718.105
    (a) One comment directed toward Appendix C is also relevant to 
paragraph (c)(6). The comment notes that the correct nomenclature for 
partial pressure of oxygen and carbon dioxide is an upper-case ``P'', 
not the lower-case ``p'' currently in use. The comment is correct, and 
the reference to the partial pressures will be changed.
    (b) Four comments oppose proposed paragraph (d), which requires the 
claimant to obtain a physician's opinion that a qualifying blood gas 
study conducted during a miner's terminal illness reflects a chronic 
respiratory or pulmonary condition caused by coal dust exposure. The 
comments suggest that qualifying scores should be presumed indicative 
of a totally disabling respiratory impairment unless the party opposing 
the claim produces evidence linking the test results to some other 
condition. While recognizing the concerns expressed by the comments, 
the Department nevertheless believes that paragraph (d) imposes an 
appropriate evidentiary burden on the claimant. Arterial blood gas 
studies conducted during a terminal illness hospitalization may be 
especially susceptible to producing low values unrelated to chronic 
respiratory or pulmonary disease. Consequently, reliance on such 
studies should be predicated on an additional showing that the 
qualifying (or abnormal) test results can be medically linked to 
chronic lung disease. One comment supported this proposal.
    (c) Two comments object to the requirement in paragraph (d) that 
the chronic respiratory or pulmonary impairment demonstrated by the 
``deathbed'' blood gas study must also be ``related to coal mine dust 
exposure.'' The Department agrees. The primary objective behind 
paragraph (d) is to ensure a connection between the qualifying blood 
gas values and a chronic respiratory or pulmonary impairment, rather 
than some other acute pathologic cause incidental to the miner's 
terminal illness. Thus, paragraph (d) addresses only the existence of a 
chronic respiratory or pulmonary impairment itself, not its cause. 
Including a requirement linking the chronic impairment to coal mine 
dust exposure is therefore inappropriate for purposes of Sec. 718.105. 
The claimant must still prove that any totally disabling respiratory or 
pulmonary impairment demonstrated by these blood gas study results 
arose out of coal mine employment in order to receive benefits, 20 CFR 
718.204(c)(1). Paragraph (d) has been revised to delete

[[Page 54978]]

the phrase ``related to coal mine dust exposure.''
20 CFR 718.106
    (a) Five comments urge the Department to restore the current 
paragraph (c), 20 CFR 718.106(c), which was omitted from the proposed 
regulation. This paragraph provides that the negative findings on a 
biopsy are not conclusive evidence that pneumoconiosis is absent, while 
positive findings do constitute evidence of the disease. The omission 
was inadvertent, and paragraph (c) will be restored in the final rule.
    (b) Two comments oppose the requirement in paragraph (a) that the 
autopsy protocol must include a gross macroscopic inspection of the 
lungs. The comments suggest that the requirement would implicitly 
preclude a pathologist from submitting an opinion based exclusively on 
a review of microscopic tissue samples. Paragraph (a) was not altered 
when the Department proposed changes to Sec. 718.106. This provision 
only requires macroscopic findings for purposes of the autopsy itself; 
no such findings are required for a reviewing physician. Consequently, 
a physician other than the autopsy prosector may submit an opinion 
based exclusively on the microscopic tissue samples. No change is 
necessary to permit such opinions.
    (c) Several comments urge the Department to adopt the criteria for 
diagnosing pneumoconiosis by autopsy or biopsy generated by the 
American College of Pathologists and Public Health Service in 1979. The 
Department has previously declined to promulgate specific pathological 
standards for diagnosing pneumoconiosis by autopsy or biopsy. 45 FR at 
13684 (Feb. 29, 1980); 48 FR at 24273 (May 31, 1983). Furthermore, the 
record does not contain any evidence addressing, or establishing, a 
consensus in the medical community about the accepted standards for 
diagnosing pneumoconiosis by autopsy or biopsy. Although the comment 
refers to Kleinerman et al., ``Pathologic Criteria for Assessing Coal 
Workers' Pneumoconiosis,'' in the Archives of Pathology and Laboratory 
Medicine (June 1979), the record does not establish whether this 
article reflects the current prevailing standards for diagnosing 
pneumoconiosis. The recommendation is therefore rejected.
20 CFR 718.107
    (a) One comment suggests modifying the reference to ``respiratory 
impairment'' in paragraph (a) to ``respiratory or pulmonary 
impairment.'' The Department accepts this suggestion because the 
current paragraph (a) refers to ``respiratory or pulmonary 
impairment,'' and the omission of ``pulmonary'' was inadvertent. 
Another comment recommended adding disability and disability causation 
to the list of issues for which a party may submit ``other medical 
evidence.'' Paragraph (a) is unchanged from the current provision, 
except as described in the previous discussion, and satisfactorily sets 
forth the general purposes for which ``other medical evidence'' may be 
offered. The suggested change is therefore unnecessary.
    (b) One comment supports the addition of proposed paragraph (b).

Subpart C

20 CFR 718.201
    (a) In its initial notice of proposed rulemaking, 62 FR 3343, 3376 
(Jan. 22, 1997), the Department proposed revising the definition of the 
term ``pneumoconiosis'' to recognize the progressive nature of the 
disease. The Department also proposed clarifying the existing 
definition to make clear that obstructive lung disease may fall within 
the definition of pneumoconiosis if it is shown to have arisen from 
coal mine employment. The proposal would not alter the current 
regulations' requirement that each miner bear the burden of proving 
that he has pneumoconiosis, 20 CFR 718.403, 725.202(b); proposed 
Secs. 725.103, 725.202(d)(2)(i). Thus, notwithstanding the proposed 
revision, in order to demonstrate that he has pneumoconiosis, each 
miner would be required to prove that his lung disease arose out of 
coal mine employment. If a miner's chest X-rays, autopsy or biopsy 
demonstrate the presence of the disease, and the miner has at least ten 
years of coal mine employment, he is aided by a statutory presumption 
that his pneumoconiosis arose out of coal mine employment. 30 U.S.C. 
921(c)(1). If, however, the miner fails to demonstrate the existence of 
pneumoconiosis by means of X-ray, biopsy or autopsy, he must prove that 
his lung disease arose out of coal mine employment in order to carry 
his burden of proof and establish that he has pneumoconiosis.
    A number of commenters representing coal mine operators and the 
insurance industry object strongly to both revisions, arguing that the 
Department lacks the authority to elaborate on the statute's definition 
of pneumoconiosis, and that, in any event, 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). The commenters also argue that the Department's 
proposed revision lacks a sound medical basis and would therefore 
unjustifiably increase the number of claims approved. In support of 
their arguments, these commenters presented testimony at the 
Department's Washington, DC, hearing from a panel of physicians with 
expertise in pulmonary medicine. Transcript, Hearing on Proposed 
Changes to the Black Lung Program Regulations (July 22, 1997), pp. 19-
83.
    The Department also received comments, as well as testimony, 
supporting the proposed changes from black lung associations, miners, 
and several physicians with expertise in pulmonary medicine. Among the 
favorable comments was one from NIOSH, which approved both aspects of 
the Department's proposed revision to Sec. 718.201. In so doing, NIOSH 
referenced its own 1995 publication, the same document that the 
Department had cited in its initial notice of proposed rulemaking, 
``National Institute for Occupational Safety and Health, Occupational 
Exposure to Respirable Coal Mine Dust,'' Secs. 4.1.2, 4.2.2 et seq. 
(1995). 62 FR 3343 (Jan. 22, 1997).
    NIOSH was created by the Occupational Safety and Health Act ``in 
order to carry out the policy set forth in section 651'' of that Act as 
well as to perform certain functions in support of the Occupational 
Safety and Health Administration. 29 U.S.C. 671. Among its other 
provisions, section 651 encourages the Occupational Safety and Health 
Administration to ``explor[e] ways to discover latent diseases, 
establish [] causal connections between diseases and work in 
environmental conditions, and conduct [] other research relating to 
health problems.'' 29 U.S.C. 651(b)(6). Accordingly, Congress created 
NIOSH as a source of expertise in occupational disease and as an expert 
in the analysis of occupational disease research. Given the widely 
divergent comments received from medical professionals on this proposed 
regulation, the Department sought additional guidance from NIOSH by 
providing it with all of the comments and testimony the Department had 
received relevant to the proposed revisions to Sec. 718.201. The 
Department requested that NIOSH advise it whether any of the material 
altered that agency's original opinion.
    NIOSH concluded as follows:


[[Page 54979]]


    The unfavorable comments received by DOL do not alter our 
previous position: NIOSH scientific analysis supports the proposed 
definitional changes. Research indicates that the proposed changes 
are reasonable and could be incorporated to further refine the 
definition of pneumoconiosis in the BLBA regulations.

Letter from Dr. Paul Schulte, Director, Education and Information 
Division (Dec. 7, 1998). In addition to the 1995 NIOSH publication, Dr. 
Schulte cited several recent studies and other sources: ``Coal mining 
and chronic obstructive pulmonary disease: a review of the evidence'' 
[Coggon and Newman-Taylor 1998]; ``The British Coal Respiratory Disease 
Litigation'' [Judgment of Mr. Justice Turner]; ``Progression of simple 
pneumoconiosis in ex-coalminers after cessation of exposure to coalmine 
dust'' [Donnan et al. 1997]; ``Adverse effects of crystalline silica 
exposure'' [American Thoracic Society (ATS) 1997]; ``Risk of silicosis 
in a Colorado mining community'' [Kriess and Zehn 1996]; and ``Risk of 
silicosis in a cohort of white South African gold miners'' [Hnizdo and 
Sluis-Cremer 1993]. He concluded as follows:

    These publications provide additional support for the NIOSH 
position stated in the August 20, 1997 letter: ``NIOSH continues to 
support the proposed amendment to Section 718.201 to include chronic 
obstructive pulmonary disease in the definition of pneumoconiosis; 
NIOSH also supports the revision of the definition of pneumoconiosis 
to reflect the scientific evidence that pneumoconiosis is an 
irreversible, progressive condition that may become detectable only 
after cessation of coal mine employment, in some cases.''

    Given this NIOSH review and conclusion, the Department sees no 
scientific or legal basis upon which to alter its original proposal. To 
the extent that the Department was required to consult with NIOSH, it 
has now done so. Finally, as addressed elsewhere in this proposal, the 
Department believes that it possesses the statutory authority to 
promulgate a legislative regulation defining the term 
``pneumoconiosis.'' See Old Ben Coal Co. v. Scott, 144 F.3d 1045, 1048 
(7th Cir. 1998), citing Peabody Coal Co. v. Spese, 117 F.3d 1001, 1009-
1010 (7th Cir. 1997) (en banc).
    (b) One commenter objects to the proposed definition of ``legal 
pneumoconiosis'' on the ground that Sec. 718.202(a)(2) does not contain 
the requirement that the covered disease must be a ``dust'' disease of 
the lung. The commenter also believes that this definition would 
include all obstructive pulmonary disease. The Department disagrees 
with both points. Section 718.201 begins in paragraph (a) with the 
statutory definition of pneumoconiosis, stating that pneumoconiosis 
means a chronic ``dust'' disease of the lung and its sequelae. 
Paragraph (a)(2) is a subdivision of the introductory paragraph and in 
no way contradicts it. In fact, by its very terms, the proposed 
definition of pneumoconiosis would cover only that lung disease arising 
out of coal mine employment, i.e., lung disease significantly related 
to, or substantially aggravated by, dust exposure in coal mine 
employment. Sec. 718.201(b).
    (c) Two commenters argue that Congress rejected an amendment to the 
definition of pneumoconiosis that would have included obstructive lung 
disorders, and that the Department therefore lacks the authority to 
make such a change. Above, the Department explained that Congress's 
consideration of, but failure to enact, legislation on particular 
subjects does not bar the Department from promulgating regulations on 
those subjects, provided the Department is acting within the scope of 
Congress's grant of regulatory authority. Thus, the Department does not 
agree that Congressional inaction renders invalid its proposed 
amendment of the definition of ``pneumoconiosis.''
20 CFR 718.204
    (a) In reviewing the comments submitted in response to the initial 
notice of proposed rulemaking, the Department realized that it had 
inadvertently omitted language from the current version of 20 CFR 
718.204(c)(4) setting out circumstances under which a claimant may 
establish total disability by means of a medical report. The Department 
intended no change in the regulation's meaning and has restored the 
omitted language to proposed Sec. 718.204(b)(2)(iv).
    (b) A number of commenters object to the Department's proposed 
amendment to subsection (a), while others support it. That revision is 
intended to ensure that disabling nonrespiratory conditions are not 
considered a bar to entitlement when the miner also suffers from 
totally disabling pneumoconiosis. As the Department explained in its 
initial notice of proposed rulemaking, the revision announces the 
Department's preference for the Sixth Circuit's decision in 
Youghiogheny & Ohio Coal Co. v. McAngues, 996 F.2d 130 (6th Cir. 1993), 
cert. den., 510 U.S. 1040 (1994), over the Seventh Circuit's decision 
in Peabody Coal Co. v. Vigna, 22 F.3d 1388 (7th Cir. 1994). 62 FR 3344-
45 (Jan. 22, 1997). After preparation of the Department's proposal, the 
Sixth Circuit held, for the first time in a Part 718 case, that a miner 
may not be denied black lung benefits simply because he may also be 
totally disabled by a coexisting non-respiratory impairment. Cross 
Mountain Coal Co., Inc. v. Ward, 93 F.3d 211, 216-217 (6th Cir. 1996). 
The commenters have provided no basis upon which to alter the 
Department's original proposal.
    (c) A number of commenters object to the Department's proposal to 
revise subsection (b)(1) to codify the Department's position that a 
miner is entitled to benefits only if his respiratory or pulmonary 
impairment is totally disabling. The commenters urge that the 
Department adopt a ``whole person'' approach, allowing an award of 
benefits if pneumoconiosis contributed at least in part to the miner's 
overall disability, considering both respiratory and nonrespiratory 
impairments. Although the commenters argue that the Department's 
position violates the statute, the Third and Fourth Circuits have 
reached a contrary conclusion. Beatty v. Danri Corp. & Triangle 
Enterprises, 49 F.3d 993 (3d Cir. 1995); Jewell Smokeless Coal Corp. v. 
Street, 21 F.3d 241 (4th Cir. 1994). Because the commenters offer no 
other basis upon which to amend the Department's proposal, subsection 
(b)(1) has not been changed.
    (d) A number of commenters take issue with the Department's 
proposal to define disability causation in subsection (c). Several 
commenters state that the Department has no authority to issue such a 
regulation, suggesting that the statutory language is clear. The 
Department disagrees. The statute authorizes the payment of benefits 
``[i]n the case of total disability of a miner due to pneumoconiosis,'' 
30 U.S.C. 922(a)(1), and explicitly provides that ``[t]he term ``total 
disability'' has the meaning given it by regulations * * * of the 
Secretary of Labor under part C of this title * * *.'' 30 U.S.C. 
902(f)(1). Even absent such an explicit grant of rulemaking authority, 
Congress' use of the broad phrase ``due to'' leaves significant 
questions in resolving the issue of disability causation. In Atlanta 
College of Medical and Dental Careers, Inc. v. Riley, 987 F.2d 821 
(1993), the D.C. Circuit noted that the Secretary of Education was 
authorized to promulgate interpretative regulations under the Student 
Loan Default Prevention Initiative Act. That statute authorized the 
Secretary to calculate a default rate from participating schools, but 
required him to exclude loans which ``due to improper servicing or 
collection, would result in an inaccurate or incomplete calculation.'' 
Addressing Congress' use of the phrase ``due to,'' the court held:


[[Page 54980]]


    And must the school show ``but for'' causation, proximate 
causation or merely some reasonable link? The statute itself 
provides no answers to these riddles; accordingly, under Chevron's 
second step, we would defer to any reasonable interpretation of the 
``due to'' language that the Secretary proffered. See also Jerry 
Mashaw, A Comment on Causation, Law Reform, and Guerilla Warfare, 73 
Geo. L. Rev. 1393, 1396 (1985) (identifying the ``cause'' of 
something necessarily implicates a policy choice).

Id. at 830. The Department's definition of disability causation under 
the Black Lung Benefits Act is similarly necessary and well within the 
scope of its regulatory authority.
    Other commenters argue that the Department has selected the wrong 
definition. Several commenters suggest that the Department delete the 
word ``substantially'' from paragraph (c)(1). Another asks that the 
standard be ``due at least in part.'' One commenter requests that the 
Department add the word ``substantially'' to paragraphs (c)(1)(i) and 
(c)(1)(ii). Several comments suggest that the term ``substantially 
contributing'' is undefined, and urge that the Department set a 
percentage of disability as the threshold, while another commenter asks 
that the Department use the term ``actual contributing cause'' in order 
to bar the award of benefits where pneumoconiosis has made only a de 
minimis contribution to total disability.
    The Department discussed its selection of the ``substantially 
contributing cause'' standard in its initial notice of proposed 
rulemaking. 62 FR 3345 (Jan. 22, 1997). The Department explained that 
its selection was intended to codify a body of caselaw from various 
federal appellate courts that differed very little in determining 
disability causation. In addition, the proposal paralleled the standard 
used by the Department to determine whether a miner's death was caused 
by pneumoconiosis. Because the language of the death standard is a 
direct reflection of Congressional intent, see 48 FR 24275-24278 (May 
31, 1983), the Department believes that it should be used for 
disability causation as well. Finally, the Department does not agree 
that a percentage threshold is appropriate. As the Department 
previously explained, the ``substantially contributing cause'' standard 
requires that pneumoconiosis make a tangible and actual contribution to 
a miner's disability. The standard is also further defined in the 
proposed regulation. It requires that pneumoconiosis must either have 
an adverse effect on the miner's respiratory or pulmonary condition or 
worsen an already totally disabling respiratory or pulmonary 
impairment. Whether a particular miner meets the ``substantially 
contributing cause'' standard is a matter to be resolved based on the 
medical evidence submitted in each case.
    Finally, several commenters suggest that the Department's proposal 
will allow compensation where a miner's totally disabling respiratory 
impairment has been caused by cigarette smoking. Neither the Black Lung 
Benefits Act, nor the court of appeals decisions, nor the Department's 
proposed regulation allows benefits to be awarded where a miner's 
totally disabling respiratory impairment is caused solely by cigarette 
smoking. The courts have held irrelevant, however, the existence of 
causes of a miner's total respiratory or pulmonary disability in 
addition to pneumoconiosis. See Jonida Trucking, Inc. v. Hunt, 124 F.3d 
739, 744 (6th Cir. 1997) (coexisting heart disease). In such a case, 
the miner meets the statutory and regulatory criteria for an award of 
benefits.
20 CFR 718.205
    (a) Several comments request that the Department reinstate 
unrelated death benefits, that is, benefits to surviving spouses of 
miners who were totally disabled due to pneumoconiosis at the time of 
their death but who did not die due to pneumoconiosis. Although such 
benefits were formerly available, Congress amended the Act in 1981 to 
require that a surviving spouse who filed her claim on or after January 
1, 1982 establish that the miner died due to pneumoconiosis. Pub. L. 
97-119, 95 Stat. 1635, Sec. 203(a)(2), (3). The Department cannot issue 
regulations contrary to the expressed will of Congress.
    Another comment, however, suggests that the Department has done 
just that by proposing that a surviving spouse may establish death due 
to pneumoconiosis by proving that pneumoconiosis hastened the miner's 
death. The Department disagrees. Rather, the Department has simply 
proposed codifying a standard that has been unanimously adopted by the 
federal courts of appeals, a fact recognized by other commenters. In 
addition to the Third, Fourth, Sixth, and Seventh Circuit decisions 
cited in the initial notice of proposed rulemaking, 62 FR 3345-3346 
(Jan. 22, 1997), the Tenth and Eleventh Circuits have also deferred to 
the Director's interpretation of the current regulation, and announced 
their support for the standard that the Department is proposing to 
codify. Northern Coal Co. v. Director, Office of Workers' Compensation 
Programs, 100 F.3d 871, 874 (10th Cir.1996); Bradberry, v. Director, 
Office of Workers' Compensation Programs, 117 F.3d 1361, 1365-1366 
(11th Cir. 1997). The Department's proposal thus does no more than 
recognize the decisions of appellate courts with jurisdiction over more 
than 90 percent of the claims filed under the Black Lung Benefits Act. 
The suggestion that the Department has violated Congressional intent is 
simply incorrect.
    (b) One commenter asks the Department to apply the standard set 
forth in subsection (b)(2) to claims filed on or after January 1, 1982, 
the effective date of the Black Lung Benefits Amendments of 1981. 
Subsection (b)(2) permits an award of benefits in a survivor's claim 
filed before January 1, 1982 if death was due to multiple causes, 
including pneumoconiosis, and it is not medically feasible to 
distinguish which disease caused death or the extent to which 
pneumoconiosis contributed to the miner's death. This provision is 
derived in substantial part from the presumption set forth in section 
411(c)(2) of the Act, 30 U.S.C. 921(c)(2), and implemented by 20 CFR 
718.304. Under section 411(c)(2), a deceased miner with ten or more 
years of coal mine employment, who died from a respirable disease, is 
presumed to have died due to pneumoconiosis. In implementing this 
provision, the Secretary added Sec. 718.303(a)(1) to the regulations, 
allowing death to be found due to a respirable disease if such disease 
was one of several causes of the miner's death and it is not feasible 
to determine which disease caused death or the extent to which the 
respirable disease contributed to the cause of death. Section 
718.205(b)(2) permitted an award under similar circumstances in cases 
in which the miner had less than 10 years of coal mine employment, but 
the survivor had established that pneumoconiosis was one of the 
multiple causes of death. In 1981, Congress eliminated the section 
411(c)(2) presumption for survivors' claims filed on or after January 
1, 1982. Pub. L. 97-119, Sec. 202(b)(1). In promulgating regulations to 
effectuate Congress's intent, the Department applied the same 
limitation to subsection (b)(2). See comment (p), 48 FR 24278 (May 31, 
1983). Because subsection (b)(2) is so closely connected with the 
section 411(c)(2) presumption, the Department continues to believe that 
it may not apply this regulatory provision to claims filed on or after 
January 1, 1982.

[[Page 54981]]

Appendix B to Part 718

    (a) The proposed changes to Appendix B are designed to implement 
the Department's proposed requirement that physicians use the flow-
volume loop in reporting the results of pulmonary function tests. See 
Explanation of proposed Sec. 718.103. The Department invites comment on 
these changes.
    (b) A number of commenters suggest that one Appendix provision is 
unnecessarily restrictive. It requires that the two highest FEV1 
results of the three acceptable tracings agree within 5 percent or 100 
ml, whichever is greater. Appendix B(2)(ii)(G). They suggest that the 
standard either be eliminated entirely, or that it be replaced with a 
variability limit of 10 percent or 200 ml. One comment recommends that 
the Department should have a separate standard for ensuring the 
reliability of FVC results. As proposed, Appendix B limits the 
variability only of FEV1 and MVV results.
    The Department is reluctant to eliminate the Appendix B(2)(ii)(G) 
standard entirely; the standard provides a baseline measurement which 
serves to guarantee the reproducibility, and thus the validity, of each 
conforming pulmonary function study. However, the Department recognizes 
that there may be individuals who are physically unable to produce 
results that fall within the 5 percent limit, but whose results are, in 
the opinion of the physician administering the test, a valid reflection 
of the individual's best effort to perform the test. Accordingly, the 
Department invites comment as to how to maintain a standard that 
guarantees the reproducibility of the FEV1 and FVC values, but also 
allows consideration of valid FEV1 results in excess of the current 5 
percent requirement.
    (c) Several commenters argue that the Appendix B tables are too 
stringent and should be revised. These tables set forth pulmonary 
function test results which may establish that a miner's respiratory or 
pulmonary impairment is totally disabling. The Black Lung Benefits 
Reform Act of 1977 required the Department to consult with the National 
Institute for Occupational Safety and Health in the development of 
criteria for medical tests that accurately reflect total disability in 
coal miners. 30 U.S.C. 902(f)(1)(D). On April 25, 1978, the Department 
proposed the pulmonary function test criteria set forth in Appendix B, 
setting the ``qualifying'' values for the FEV1 and MVV test at 60 
percent of normal pulmonary function, as adjusted for sex, height, and 
age. 43 FR 17730-31 (Apr. 25, 1978). When the Department published the 
final Part 718 rules on February 29, 1980, it added tables for the FVC 
test. 45 FR 13703-06 (Feb. 29, 1980). The Department also responded to 
comments urging that the qualifying values be reduced, observing that 
although there was no consensus on the correct values, the record 
contained substantial support from experts for the 60 percent figure. 
Id. at 13711. The Department did not re-propose the Appendix B tables 
in its initial notice of proposed rulemaking, see 62 FR 3373 (Jan. 22, 
1997) (noting that the tables in Appendix B remain unchanged), and the 
commenters offer no medical support for the request that they be 
revised. Consequently, the Department has not proposed any revision of 
the table values.

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--General

20 CFR 725.2
    (a) The Department has made several technical changes to the 
language of the proposed regulation to make the regulation easier to 
read.
    (b) This proposal changes Sec. 725.2(c) to add Sec. 725.351 to the 
list of amended regulations which will apply only to claims filed after 
the effective date of the final rule. The Department's proposal 
requires the district director's development of a complete evidentiary 
record identifying the proper responsible operator. Once a case is 
referred to the Office of Administrative Law Judges, neither the 
Director, OWCP, nor a potentially liable operator identified by the 
district director will be able to submit any additional evidence on 
issues relevant to the responsible operator question. For example, only 
while a claim is pending before the district director may a potentially 
liable operator contest that it was an operator after June 30, 1973, 
that it employed the miner for one year, or that the miner's employment 
included at least one working day after December 31, 1969, 
Sec. 725.408. Accordingly, the district director must be able to obtain 
all of the information necessary to meet the Department's burden of 
proof under Sec. 725.495.
    To aid the district director in gathering such information, this 
proposal revises and streamlines Sec. 725.351, which grants district 
directors the power to issue subpoenas duces tecum. A district director 
will no longer be required to seek written approval from the Director, 
OWCP, prior to issuing such a subpoena. See explanation of 
Sec. 725.351. Because the revised regulations governing the 
identification of responsible operators, Secs. 725.407-.408, will apply 
only to newly filed claims, however, the district director's new 
authority under Sec. 725.351 must be similarly limited. Accordingly, 
Sec. 725.351 is added to the list of amended regulations which will not 
be effective with respect to claims pending on the effective date of 
the final rule.
    (c) A number of comments request that the Department make the final 
rule applicable to all pending claims. As the Department explained in 
its original proposal, 62 FR 3347-48 (Jan. 22, 1997), however, it lacks 
the statutory authority to make many changes retroactive. In addition, 
certain changes, such as the limitation on the quantity of medical 
evidence, would seriously disrupt the adjudication of currently pending 
claims if they were made universally applicable.
    (d) A number of commenters believe that the Department lacks the 
authority to make any of the changes retroactive, particularly because 
those changes will apply to subsequent claims filed by miners who have 
previously been denied benefits. They argue that subsequent claims are 
typically based on employment that ended many years ago, and that the 
insurance industry is not permitted to charge additional premiums in 
order to cover the increased liability that will result under the 
Department's proposal. In support of their argument that the Department 
is not permitted to effect such a change, they cite the Contract Clause 
of the United States Constitution. The Contract Clause is in Section 10 
of Article I, which is a series of prohibitions against actions by 
state governments. In relevant part, it states that ``[n]o State shall 
* * * pass any Bill of Attainder, ex post facto Law, or Law impairing 
the Obligation of Contracts, or grant any Title of Nobility.'' The 
Supreme Court has observed that ``[i]t could not justifiably be claimed 
that the Contract Clause applies, either by its own terms or by 
convincing historical evidence, to actions of the National 
Government.'' Pension Benefit Guaranty Corp. v. R.A. Gray & Co., 467 
U.S. 717, 732, n. 9 (1984). Thus, the Contract Clause does not bar 
Congress from enacting any legislation. Similarly, the Contract Clause 
is inapplicable to the Secretary's rulemaking by its very terms, and 
the comment has cited no precedent to the contrary.
    Moreover, the Department does not agree that its proposed 
rulemaking results in the impairment of any contracts. At the hearing 
held in Washington, D.C., on July 22-23, 199