United States Court of Appeals

               FOR THE DISTRICT OF COLUMBIA CIRCUIT

         Argued April 9, 2002     Decided June 14, 2002

                           No. 01-5278

              National Mining Association, et al.,
                            Appellants

                                v.

                  Department of Labor, et al.,
                            Appellees

          Appeal from the United States District Court
                  for the District of Columbia
                         (No. 00cv03086)

     Mark E. Solomons argued the cause for appellants.  With
him on the briefs was Laura Metcoff Klaus.

     Sushma Soni, Attorney, United States Department of Jus-
tice, argued the cause for federal appellees.  With her on the
brief were Roscoe C. Howard, Jr., United States Attorney,
and Mark B. Stern, Attorney, United States Department of
Justice.


     Thomas E. Johnson argued the cause for appellees United
Mine Workers of America.  With him on the brief were
Grant Crandall and Judith Rivlin.

     Before:  Edwards and Tatel, Circuit Judges, and
Silberman, Senior Circuit Judge.

     Opinion for the Court filed Per Curiam.

     Per Curiam:  This lawsuit challenges regulations issued by
the Secretary of Labor pursuant to the Black Lung Benefits
Act, as amended, 30 U.S.C. ss 901-945 (1994) ("BLBA" or
"Act").  The District Court upheld the regulations against all
challenges.  This appeal followed.  For the reasons stated
herein, we affirm in part and reverse in part.  The case will
be remanded to the District Court with instructions to re-
mand the case to the Department of Labor for further
proceedings consistent with this opinion.

                          I. Background

     The BLBA is a federally administered law providing bene-
fits to coal miners who are totally disabled due to pneumoco-
niosis, also known as black lung disease, and to the surviving
dependents of miners who died of the disease.  Under the
Act, coal mine operators are responsible for paying benefits
to miners whose death or total disability due to black lung
disease arose out of employment in the mines.  30 U.S.C.
s 932.  Black lung disease encompasses a cruel set of condi-
tions that afflict a significant percentage of the nation's coal
miners with "severe, and frequently crippling, chronic respi-
ratory impairment."  Usery v. Turner Elkhorn Mining Co.,
428 U.S. 1, 6 (1976) (citing, inter alia, S. Rep. No. 91-411, at 6
(1969)).  It is caused by the "long-term inhalation of coal
dust."  Id.  A rare and serious form of the disease, known as
"complicated pneumoconiosis," results in pulmonary impair-
ment and respiratory disability.  Id. at 7.  It can lead to
cardiac failure and can contribute to other causes of death. 
Id.  The purpose of the BLBA "is to satisfy a specific need
created by the dangerous conditions under which [coal miners
have] labored--to allocate to the mine operator[s] an actual,
measurable cost of [their] business."  Id. at 19.


     A miner or his survivor may seek benefits under the Act by
filing a claim with the District Director in the Department of
Labor's Office of Workers' Compensation Programs
("OWCP").  After investigating the claim, the District Di-
rector determines whether the claimant is eligible for benefits
and which employer will be held responsible.  See 20 C.F.R.
ss 725.301-725.423 (2001) (all citations to the Code of Federal
Regulations will be to the 2001 edition unless otherwise
noted).  If the employer cannot be identified, the claim is paid
out of the Black Lung Disability Trust Fund ("the Fund"),
which is financed by a tax on coal.  See 30 U.S.C. ss 932, 934; 
26 U.S.C. ss 4121, 9501(d)(1).  Either party may appeal the
District Director's determination and request a hearing be-
fore an Administrative Law Judge ("ALJ").  20 C.F.R.
ss 725.450-725.480.  The ALJ's decision may be appealed to
the Department of Labor's Benefits Review Board, id.
s 725.481, and then to the Court of Appeals for the circuit in
which the impairment occurred, 33 U.S.C. s 921(c);  20 C.F.R.
s 725.482.

     In 1997, the Secretary of Labor ("the Secretary," "the
Department," or "the government") issued a notice of pro-
posed revisions to the rules governing the adjudication of
miners' claims under the BLBA.  See Regulations Imple-
menting the Federal Coal Mine Health and Safety Act of
1969, as Amended, 62 Fed. Reg. 3338-435 (proposed Jan. 22,
1997).  The Secretary received approximately 200 comments
and held two public hearings on the proposed rules.  The
Secretary also consulted the National Institute for Occupa-
tional Safety and Health ("NIOSH"), the federal agency
charged with researching occupational health.  See 29 U.S.C.
s 671.  Congress directed the Secretary to consult with
NIOSH to establish criteria for medical tests to determine
whether coal miners are totally disabled.  30 U.S.C. s 902(f).

     In 1999, the Secretary issued another notice, announcing
revisions to certain proposed regulations.  See Regulations
Implementing the Federal Coal Mine Health and Safety Act
of 1969, as Amended, 64 Fed. Reg. 54,966-55,072 (proposed
Oct. 8, 1999).  After receiving more comments and testimony
and consulting NIOSH and other experts, the Secretary


promulgated the final rule, which would go into effect on
January 19, 2001.  See Regulations Implementing the Federal
Coal Mine Health and Safety Act of 1969, as Amended, 65
Fed. Reg. 79,920-80,107 (Dec. 20, 2000).

     The appellants in this case include mine operators, insur-
ance companies, and the National Mining Association (collec-
tively "NMA").  The BLBA requires coal mine operators to
purchase insurance to cover their liabilities under the Act. 
See 30 U.S.C. s 933 (governing employers' insurance ar-
rangements);  20 C.F.R. Part 726 (entitled "Black Lung Bene-
fits;  Requirements for Coal Mine Operator's Insurance"). 
The Secretary of Labor anticipates that the new rules will
impose costs on mine operators in the form of higher insur-
ance premiums.  See 65 Fed. Reg. at 80,030.  The Secretary's
initial analysis indicated that, in the long term, the new rules
would cause operators' insurance premiums to go up by about
39.3%, resulting in total annual costs to the industry of
approximately $57.56 million.  Id.  The Secretary's analysis
also suggested that the overall approval rate for claims
against responsible coal mine operators would increase from
7.33% to no more than 12.18%.  Id. at 80,036.  It is not clear
how much of this anticipated increase is attributable to an
anticipated increase in approval of claims that are already
pending, and how much is attributable to claims that have not
yet been filed.

     Almost immediately after the final regulations were an-
nounced, appellants sought declaratory and injunctive relief
in the United States District Court for the District of Colum-
bia.  See Am. Compl. p 1, reprinted in Joint Appendix
("J.A.") 1.  They challenged many of the rules as impermissi-
bly retroactive.  See id. pp 19-23.  They alleged that many of
the rules violated the BLBA or applicable provisions of the
Longshore and Harbor Workers Compensation Act
("LHWCA" or "Longshore Act"), 33 U.S.C. ss 901-950, many
provisions of which are incorporated by reference into the
BLBA by 30 U.S.C. s 932(a).  See Am. Compl. pp 24-26. 
They alleged that some of the rules impermissibly shifted the
burden of proof.  See id .pp 27-32.  They alleged that certain
rules ran afoul of the right to a full and fair hearing, treated


parties unequally, or were arbitrary, capricious, and an abuse
of discretion in contravention of the Administrative Procedure
Act ("APA").  See id. pp 33-43.  Finally, they alleged that the
rulemaking procedure was inadequate and that the rules
violated the due process guarantee of the Constitution.  Id.
pp 44-52.  The United Mine Workers of America and other
black lung advocates, including miners, intervened on behalf
of the Secretary.

     The District Court granted the NMA limited injunctive
relief, but ultimately granted the Secretary's motion for sum-
mary judgment, upholding the regulations in every respect. 
Nat'l Mining Ass'n v. Chao, 160 F. Supp. 2d 47 (D.D.C. 2001)
(Mem. Op.) [hereinafter "NMA"].  Rejecting the Secretary's
argument that the District Court lacked jurisdiction, the
court first found that it had jurisdiction pursuant to 28 U.S.C.
s 1331, because NMA challenged a rulemaking, rather than
an "order," of DOL.  Id. at 54-56.  Black lung benefits
determinations ("orders") may be challenged only in the
Court of Appeals.  33 U.S.C. s 921(c), (e).

     The District Court next addressed NMA's claim that many
of the rules were impermissibly retroactive, in part because
they applied to pending claims as well as claims filed after the
effective date of the regulations.  See NMA, 160 F. Supp. 2d
at 65.  The court agreed with all parties that the Secretary
was not authorized to promulgate retroactive regulations, but
found that the challenged regulations were not retroactive,
because some apply only to newly filed claims, while the
remainder "simply clarify legal principles that were already
in effect and [did] not change the substantive standards of
entitlement."  Id.  Finally, the District Court upheld the
regulations against the various substantive challenges.  Id. at
69-90.  Appellants now seek review of the District Court's
determinations.

                          II. Discussion

A.   Jurisdiction

     The government challenged the District Court's jurisdiction
to hear appellants' broad-scale attack on the Department's


regulations and reiterates that argument before us.  It is the
government's contention that the mining companies may only
challenge the regulations piecemeal, insofar as particular
provisions are brought into question, by an appeal directly to
the Court of Appeals from a compensation order of the
Benefits Review Board.  That is so, according to the govern-
ment, because the BLBA provides that a person "adversely
affected or aggrieved by a final order of the Board may
obtain review of that order in the United States court of
appeals for the circuit in which the injury occurred ..."  33
U.S.C. s 921(c) (emphasis added).

     The obvious difficulty with the government's position is
that this provision putting exclusive review jurisdiction in the
Court of Appeals speaks of orders, but Congress in passing
the APA drew a distinction between orders, which typically
follow adjudications, and regulations.  See National Treasury
Employees Union v. Weise, 100 F.3d 157, 160 (D.C. Cir. 1996)
(explaining that courts and Congress use the terms "regula-
tion" and "rule" interchangeably);  compare 5 U.S.C. s 551(4)
(defining "rule") with id. s 551(6) (defining "order").  Indeed,
the BLBA itself indicates that Congress was using order in
the same sense it used the term in the APA.  The other
provision the government points to, 33 U.S.C. s 921(e), states
that "proceedings for suspending, setting aside, or enforcing a
compensation order, whether rejecting a claim or making an
award, shall not be instituted otherwise than as provided
above" (referring to s 921(c) (emphasis added)).  That lan-
guage makes rather clear that in s 921(c) Congress used the
term "order" to refer to an adjudicatory compensation order,
not the promulgation of a regulation, and therefore the
preclusion of review other than by s 921(c) would seem not to
apply to review of a regulation.  Since Congress was silent on
how review of regulations was to be accomplished, it would
appear accordingly that persons seeking such review would
be directed by the APA to go to district court.  See Work-
place Health & Safety Council v. Reich, 56 F.3d 1465, 1467
(D.C. Cir. 1995).

     In that regard, the Supreme Court's decision in McNary v.
Haitian Refugee Center, Inc., 498 U.S. 479 (1991), instructs


us to read very carefully legislative restrictions on district
court review of generic challenges to agency action.  In the
Immigration Reform and Control Act of 1986, Congress pro-
vided that there would be "no administrative or judicial
review of a determination respecting an application for ad-
justment of status" except in accordance with that subsection,
which eventually provided for judicial review in the Court of
Appeals.  8 U.S.C. s 1160(e).  The Court held that s 210(e)
of the Reform Act did not deprive a district court of subject
matter jurisdiction of "general collateral challenges to uncon-
stitutional practices and policies used by the agency in pro-
cessing applications."  McNary, 498 U.S. at 492.

     The Court read the phrase "determination respecting an
application for adjustment of status" to refer only to an
individual adjudication - not a determination made in a
regulation.  In our case, the word order is more obviously
confined to an adjudication than the word determination, so
therefore this case, linguistically, appears a fortiori to
McNary.1  To be sure, the Court also observed that plaintiffs'
challenge to the procedures would not easily be remedied by
individual appeals to the Court of Appeals, a notion we return
to below.  Id. at 496.

     The government points to another Supreme Court case,
Thunder Basin Coal Company v. Reich, 510 U.S. 200 (1994),
holding that the Federal Mine Safety and Health Act preclud-
ed district court jurisdiction over a pre-enforcement challenge
to several Department of Labor regulations.  In that case, a

__________
     1 The Second Circuit has also recognized that the term "order"
carries a limited meaning.  In Merritt v. Shuttle, Inc., 187 F.3d 263
(2d Cir. 1999) (Merritt I), that court held that Merritt could not
bring a Bivens claim challenging an FAA order suspending his
pilot's certificate because 49 U.S.C. s 46110(a) vested review of an
FAA "order" in the Court of Appeals and his Bivens claim chal-
lenged the merits of the administrative adjudication.  By contrast,
in Merritt v. Shuttle, Inc., 245 F.3d 182, 188 (2d Cir. 2001) (Merritt
II), the Second Circuit clarified that s 46110(a), which referred only
to an FAA order, did not preclude district court jurisdiction over
Merritt's FTCA claim, which did not claim that he was either
injured or aggrieved by the order suspending his license.


mine operator refused to post the names of two United Mine
Workers of America employees - not employees of the mine
operator - who had been chosen by its employees as their
representatives to "walk around" with federal inspectors. 
The Mine Safety statute authorized the Secretary of Labor to
seek enforcement of the posting in proceedings before the
Federal Mine Safety and Health Review Commission.  Be-
fore the Secretary could do so, the mine operator, claiming
rights under both the National Labor Relations Act and the
Constitution, sought an injunction against the Labor Depart-
ment's position that the mine operator was obliged to post the
names.  The Court held that the District Court lacked juris-
diction over "such" a pre-enforcement challenge in light of the
comprehensive administrative and judicial review procedures
culminating in the Court of Appeals.  Id. at 208.  Although
the statute was silent on pre-enforcement review, this sort of
case was thought to be implicitly precluded.  The company
had simply jumped the gun by suing before the Secretary
issued a citation, and the company's argument that both the
Constitution and the National Labor Relations Act allowed it
to exclude non-employee representatives could be meaningful-
ly reviewed in the Court of Appeals.  It is important to note
that the case did not involve a regulation, which is typically
treated differently from an adjudication.  United States v.
Florida East Coast Ry. Co., 410 U.S. 810, 820-21 (1973). 
Indeed, under the Mine Safety Act safety standards are
issued as regulations and are explicitly reviewable in the
Court of Appeals. 30 U.S.C. s 811(d).2

     The government also relies on two circuit court cases,
Compensation Dep't of Dist. Five v. Marshall, 667 F.2d 336,
340-44 (3d Cir. 1981), and Louisville & Nashville R.R. v.
Donovan, 713 F.2d 1243, 1245-47 (6th Cir. 1983), denying pre-
enforcement review under this very statute.  The first of
these, upon which the second relies, involved a request for an
injunction brought by the United Mine Workers against the

__________
     2 The Court did not indicate how it would treat the review of a
regulation that was not a safety standard.  Compare Chamber of
Commerce of the United States v. Dep't of Labor, 174 F.3d 206
(D.C. Cir. 1999), with id. at 213 (Silberman, J., dissenting).


Labor Department to prevent the Secretary from indepen-
dently examining x-rays presented by those seeking eligibility
for black lung benefits.  The statute obliged the Secretary to
accept a radiologist's interpretation of an x-ray if certain
requirements were met.  The Secretary's position was that
although his Office of Workers' Compensation was bound,
neither an ALJ nor the independent Benefits Review Board
was so bound, and therefore nothing prevented the Secretary
from turning over a competing interpretation to the mine
operator to be used as rebuttal evidence.

     The Third Circuit held that the District Court lacked
jurisdiction because the "scheme of review" established by
Congress "for determination of black lung benefits" was
exclusive;  it provided administrative review and then review
in the Court of Appeals.  There was no reason why the
United Mine Workers could not challenge the Secretary's
enforcement policy in an individual adjudication before the
Benefits Review Board and, if necessary, in the Court of
Appeals.  The case therefore bears a strong resemblance to
Thunder Basin;  a plaintiff sought to short-circuit the admin-
istrative process by challenging a Department enforcement
position in a district court.  Compare Compensation Depart-
ment, 667 F.2d at 340, with Thunder Basin, 510 U.S. at 216.

     The Sixth Circuit's Louisville & Nashville R.R. case is
somewhat more problematic.  There, fifteen railroads sought
and gained an injunction in district court preventing the
Secretary from extending coverage of the BLBA to railroad
employees.  The Department of Labor had issued guidelines
defining the statutory term "transportation of coal" to include
railroad employees if they were transporting coal between the
extraction site and the tipple and if their work was necessary
to the extraction process.  The Sixth Circuit reversed, follow-
ing the Third Circuit's analysis in Compensation Department,
pointing out that any railroad could contest the Secretary's
position before the Benefits Review Board, and if necessary
challenge an order awarding benefits in the Court of Appeals. 
Although the guidelines involved seem a bit more generic
than the enforcement policies implicated in either Thunder
Basin or Compensation Department, the Secretary had not


issued a formal regulation, as is true in our case, and again as
in Compensation Department, 667 F.2d at 334, there was no
reason to believe that a railroad's legal position, if correct,
could not be fully remedied through review in the Court of
Appeals.  Louisville & Nashville RR, 713 F.2d at 1246-47.3

     In the case at bar the Secretary of Labor has chosen, as
was not true in any of the cases upon which the government
relies, to gain all of the law-declaring attributes of an APA
notice-and-comment rulemaking.  Trans-Pacific Freight Con-
ference of Japan/Korea v. Federal Maritime Comm'n, 650
F.2d 1235, 1244-45 (D.C. Cir. 1980) (distinguishing notice-
and-comment rulemaking, which is "prospective in operation
and general in scope," from adjudications).  Accordingly, the
cases upon which she relies do not really support her position. 
Moreover, the regulations before us are challenged primarily
on the ground that they are impermissibly retroactive.  To
determine whether that is true it is necessary to analyze
carefully all of the regulations together as well as the entire
rulemaking process, which would not be feasible in individual
adjudications dealing with particular regulatory provisions. 
Cf. Kreschollek v. Southern Stevedoring Co., 78 F.3d 868 (3d
Cir. 1996) (holding that 33 U.S.C. s 921 did not deprive a
district court of jurisdiction over plaintiff's constitutional
claim as to the lack of a pre-deprivation hearing because the
statutory review process would be insufficient to provide him
with the full relief to which he might be entitled).  In that
respect, this case is closer to McNary than Thunder Basin. 
As such, the District Court did have jurisdiction over appel-
lants' challenges, to which we now turn.

B.   Retroactivity

     Appellants argue that some of the provisions in the new
regulations are impermissibly retroactive.  In particular, ap-

__________
     3 The Seventh Circuit, by contrast, has explained that even "an
order denying or revoking a certificate of exemption, not being a
compensation order, would not be subject to the special review
procedure established by 33 U.S.C. s 921."  Maxon Marine, Inc. v.
Director, Office of Workers' Compensation Programs, 39 F.3d 144,
146 (7th Cir. 1994).


pellants cite the following rules:  ss 718.104(d), 718.201(a)(2),
718.201(c), 718.204(a), 725.101(a)(6), 725.101(a)(31), 725.204,
725.212(b), 725.213(c), 725.214(d), 725.219(c), 725.219(d),
725.309(d), and 725.701.  We will address each rule in turn.

     1.   Legal Principles Governing Retroactivity
         
     The general legal principles governing retroactivity are
relatively easy to state, although not as easy to apply.  An
agency may not promulgate retroactive rules absent express
congressional authority.  Bowen v. Georgetown Univ. Hosp.,
488 U.S. 204, 208 (1988).  A provision operates retroactively
when it "impair[s] rights a party possessed when he acted,
increase[s] a party's liability for past conduct, or impose[s]
new duties with respect to transactions already completed." 
Landgraf v. USI Film Prods., 511 U.S. 244, 280 (1994).  In
the administrative context, a rule is retroactive if it " 'takes
away or impairs vested rights acquired under existing law, or
creates a new obligation, imposes a new duty, or attaches a
new disability in respect to transactions or considerations
already past.' "  Nat'l Mining Ass'n v. United States Dep't of
Interior, 177 F.3d 1, 8 (D.C. Cir. 1999) (quoting Ass'n of
Accredited Cosmetology Sch. v. Alexander, 979 F.2d 859, 864
(D.C. Cir. 1992)).  The critical question is whether a chal-
lenged rule establishes an interpretation that "changes the
legal landscape."  Id. (quoting Health Ins. Ass'n of Am., Inc.
v. Shalala, 23 F.3d 412, 423 (D.C. Cir. 1994)).  It is undisput-
ed here that the Secretary was not authorized to promulgate
retroactive rules governing BLBA benefits determinations. 
Hence, the parties dispute only whether the challenged regu-
lations are retroactive.

     The Secretary argues that none of the rules is retroactive,
even as applied to pending claims, because all are merely
procedural and do not confer new substantive rights or
liabilities.  See Landgraf, 511 U.S. at 275 ("Changes in proce-
dural rules may often be applied in suits arising before their
enactment without raising concerns about retroactivity.").  It
is true that purely procedural rules often do not operate
retroactively even when applied to transactions predating
their institution.  This is because such rules often regulate


only "secondary rather than primary conduct."  Id.  Where a
"procedural" rule changes the legal landscape in a way that
affects substantive liability determinations, however, it may
operate retroactively.  See Martin v. Hadix, 527 U.S. 343,
359 (1999) (noting that, in Landgraf, the Court "took pains to
dispel the 'suggest[ion] that concerns about retroactivity have
no application to procedural rules' ") (quoting Landgraf, 511
U.S. at 275 n.29).

     Rather than rely on "procedural" and "substantive" labels,
a court must "ask whether the [regulation] operates retroac-
tively."  Id.  This inquiry involves a "commonsense, function-
al judgment about 'whether the new provision attaches new
legal consequences to events completed before its enact-
ment.' "  Id. at 357-58 (quoting Landgraf, 511 U.S. at 270). 
Thus, where a rule "changes the law in a way that adversely
affects [a party's] prospects for success on the merits of the
claim," it may operate retroactively even if designated "proce-
dural" by the Secretary.  Ibrahim v. District of Columbia,
208 F.3d 1032, 1036 (D.C. Cir. 2000).

     The Secretary argues, and the District Court agreed, that
none of the challenged rules changes the landscape, because
the rules merely clarify the Secretary's position or conform to
cases decided by the Courts of Appeals.  In analyzing each
new regulation, we first look to see whether it effects a
substantive change from the agency's prior regulation or
practice.  If a new regulation is substantively consistent with
prior regulations or prior agency practices, and has been
accepted by all Courts of Appeals to consider the issue, then
its application to pending cases has no retroactive effect.  If a
new regulation is substantively inconsistent with a prior
regulation, prior agency practice, or any Court of Appeals
decision rejecting a prior regulation or agency practice, it is
retroactive as applied to pending claims.

     Some of the challenged rules here codify the results of a
case in one circuit while effectively reversing a case in
another circuit in which the court rejected the Secretary's
practice or policy.  Such rules change the legal landscape as
applied to cases that were pending when the regulations were


promulgated.  See National Mining, 177 F.3d at 8 (explain-
ing that "[w]here before there was 'a range of possible
interpretations,' " of the relevant statutes, a rule may estab-
lish " 'a precise interpretation' " that changes the legal land-
scape) (citing Health Ins. Ass'n, 23 F.3d at 423-24).  It goes
without saying that such rules change the law for cases
pending in the circuit that previously rejected the Secretary's
approach.  In those cases, the operators insured against the
filed claims based on the law in effect at the time the claims
were filed.  Less obviously, the regulations preclude the
courts in other circuits from adopting the view of their sister
court rejecting the Secretary's position, a possibility that was
still available when the cases were initially filed.  Thus, to the
extent that a new rule reflects a substantive change from the
position taken by any of the Courts of Appeals and is likely to
increase liability, that rule is impermissibly retroactive as
applied to pending claims.

     2.   Application of Legal Principles to Challenged Rules
         
     We find some of the challenged rules to be impermissibly
retroactive as applied to claims that were pending on the
regulations' effective date.  None of the new regulations is
retroactive as to claims filed on or after the effective date. 
The distinction between pending and newly filed claims is one
on which appellants rely in their briefs.  See Br. for Appel-
lants at 15 n.6 (stating that the relevant date for purposes of
retroactivity is the date the claim is filed, as that is the last
date on which the operators' and insurers' transactions are
closed and expectations are settled);  Reply Br. for Appellants
at 4 (arguing that the Secretary "fails to explain why key
provisions are expressly made retroactively applicable to
pending and previously filed claims," while saying nothing
about claims filed after the effective date).  Moreover, NMA
never affirmatively argues that the rules should be considered
retroactive as applied to claims first filed after the effective
date.  Nor would the record support such an argument.

     Appellants do argue that the regulations are retroactive as
applied to newly filed claims when those claims are "subse-
quent claims."  We reject this argument.  Under both the


new and old regulations, a miner whose claim is initially
denied may later file a new claim if he subsequently develops
black lung disease or can show that another condition of
entitlement has changed.  See 20 C.F.R. s 725.309(d).  As we
explain in more detail below, a claimant bringing such a claim
still bears the burden of demonstrating that he meets all of
the relevant conditions.  For this reason, we agree with the
Secretary that such claims are new claims to which the
application of the new regulations is permissible.

     20 C.F.R. s 718.104(d):  The "treating physician rule" in-
structs the officer adjudicating a miner's claim to consider the
relationship between the miner and any treating physician
whose report is submitted when determining whether the
miner suffers from black lung disease and whether he was
totally disabled or died because of the disease.  The disputed
rule instructs the officer to consider the nature of the rela-
tionship (a doctor's opinion is entitled to more weight if he
has treated the miner for pulmonary, as opposed to non-
pulmonary, conditions), its duration, the frequency of treat-
ment, and the extent of treatment in weighing the doctor's
opinion along with the other evidence.  20 C.F.R.
s 718.104(d)(1)-(4).  The regulation provides that in "appro-
priate cases," the doctor-patient relationship "may constitute
substantial evidence in support of the adjudication officer's
decision to give that physician's opinion controlling weight,"
but only when the weight given is based on the credibility of
that physician's opinion "in light of its reasoning and docu-
mentation, other relevant evidence and the record as a
whole."  Id. s 718.104(d)(5) (emphasis added).  It applies
both to pending claims and claims filed after the regulations'
effective date.  See id. ss 718.2, 725.4(a) (setting forth the
applicability of the regulations in Part 718).  The old rule said
nothing about the relationship between the miner and the
evaluating doctor.  See 20 C.F.R. s 718.104 (2000).

     We hold that treating physician rule is not retroactive,
because it codifies judicial precedent and does not work a
substantive change in the law.  NMA argues that the rule
contravenes a number of court decisions.  This argument is
unfounded.  The consensus among courts has been that an


agency adjudicator may give weight to the treating physi-
cian's opinion when doing so makes sense in light of the
evidence and the record, but may not mechanistically credit
the treating physician solely because of his relationship with
the claimant.  For example, in Peabody Coal Co. v. McCand-
less, 255 F.3d 465, 469 (7th Cir. 2001), relied upon by NMA,
the Seventh Circuit restated its disapproval of "any mechani-
cal rule that the views of a treating physician prevail" (citing
Consolidation Coal Co. v. OWCP, 54 F.3d 434, 438 (7th Cir.
1995)).  Instead, the Seventh Circuit has repeatedly demand-
ed that the adjudicator explain his or her decision to credit
the treating physician in terms of "a medical reason," id., or
explain why the opinion of the treating physician was viewed
to be "better reasoned" than the opinions of non-treating
physicians, Consolidation Coal Co., 54 F.3d at 438;  see also
Amax Coal Co. v. Beasley, 957 F.2d 324, 327 (7th Cir. 1992)
(holding, in a case where both doctors agreed that coal
exposure probably had not caused the miner's death, that an
ALJ may not disregard uncontradicted medical evidence nor
give more weight to the examining physician "solely because
that doctor personally treated the claimant") (emphasis in
original).  These holdings are codified in the new
s 718.104(d), which by its terms allows an adjudicator to give
weight to the treating physician's opinion only when that
decision is supported by the opinion's "reasoning and docu-
mentation" in light of the other evidence in the record.  20
C.F.R. s 718.104(d)(5).

     The other cases cited by appellants similarly express the
principles embodied in the new rule.  In Sterling Smokeless
Coal Co. v. Akers, 131 F.3d 438, 441 (4th Cir. 1997), the
Fourth Circuit vacated an award of benefits where the ALJ
had "mechanistically credited, to the exclusion of all other
testimony," the opinions of two examining physicians who had
only treated the miner for a month, despite allegations that
the two doctors had not independently evaluated the miner
themselves.  The court acknowledged that the opinions of
treating physicians can be "deserv[ing of] especial consider-
ation," but rejected any requirement or presumption that
their opinions automatically be given greater weight.  Id.


(quoting Grizzle v. Pickands Mather & Co., 994 F.2d 1093,
1097 (4th Cir. 1993)).

     Likewise, the Sixth Circuit recently summarized its law in
Peabody Coal Co. v. Groves, 277 F.3d 829 (6th Cir. 2002). 
Reviewing past cases, the court explained that opinions of
treating physicians are entitled to greater weight, but should
not "automatically be presumed to be correct";  rather, "their
opinions should be 'properly credited and weighed.' "  Id. at
834 (quoting Tussey v. Island Creek Coal Co., 982 F.2d 1036,
1042 (6th Cir. 1993)).  Adjudicators must "examine the medi-
cal opinions of treating physicians on their merits and ...
make a reasoned judgment about their credibility."  Id.; 
accord Griffith v. Director, OWCP, 49 F.3d 184, 186-87 (6th
Cir. 1995) (holding that an ALJ was not required to give
greater weight to the opinion of the treating physician where
the physician was equivocal as to the cause of the miner's
disease).

     In short, appellants do not cite a single case from any
circuit in which a Court of Appeals espoused principles at
odds with the new rule embodied in s 718.104(d).  As the
cases demonstrate, the courts to consider the issue have
adopted the balanced policy reflected in the new rule.  Thus,
the rule does not upset settled expectations, and it is not
retroactive as applied to pending claims for benefits.

     20 C.F.R. s 718.201(a)(2):  NMA argues that the new rule
in s 718.201(a), which defines pneumoconiosis, is impermissi-
bly retroactive.  Section 718.201(a) parrots the statutory defi-
nition of pneumoconiosis, i.e., "a chronic dust disease of the
lung and its sequelae, including respiratory and pulmonary
impairments, arising out of coal mine employment."  See 30
U.S.C. s 902(b).  The regulation goes on to define pneumoco-
niosis as including both medical or "clinical" pneumoconiosis
and statutory or "legal" pneumoconiosis.  20 C.F.R.
s 718.201(a).  Legal pneumoconiosis is defined to include
"any chronic lung disease or impairment ... arising out of
coal mine employment," including "any chronic restrictive or
obstructive pulmonary disease arising out of coal mine em-
ployment."  Id. s 718.201(a)(2).


     NMA challenges as retroactive the inclusion of restrictive
or obstructive pulmonary disease in the definition of pneumo-
coniosis.  It argues that most courts require individual min-
ers to prove the causal relationship between mining and their
obstructive lung disease, and that the new rule will change
this.  This argument is misplaced.  NMA concedes that the
record supports the premise that obstructive lung disease
may be caused by mining exposure and can contribute to a
miner's disability.  Br. for Appellants at 17 n.8.  The new
rule does no more than reflect this reality.  It does not, as
appellants suggest, create a presumption that all or even
most obstructive disease is caused by exposure to coal dust. 
The District Court correctly found that, under both the old
and new regulations, "each miner bear[s] the burden of
proving that his obstructive lung disease did in fact arise out
of his coal mine employment."  NMA, 160 F. Supp. 2d at 79
(quoting 65 Fed. Reg. at 79,938) (emphasis added).

     NMA also alleges that the preamble to the regulations
impermissibly suggests that an adjudicator may ignore a
medical report if the reporting doctor concludes that a min-
er's obstructive lung disease was caused by smoking, rather
than mining.  This objection is entirely meritless.  The regu-
lation's plain text in no way indicates that medical reports will
be excluded if they conclude that a particular miner's obstruc-
tive disease was caused by smoking, rather than mining. 
Indeed, the preamble itself states that the revised definition
does not alter the requirement that individual miners must
demonstrate that their obstructive lung disease arose out of
their work in the mines.  See 65 Fed. Reg. at 79,938.  And
appellants acknowledge that this regulatory statement is ac-
ceptable.  Br. for Appellants at 17 n.8.  To the extent that
appellants' objection is based on anticipated misapplications
of the rule by agency adjudicators, it is unripe for review. 
Appellants may object to applications of the rule only in the
context of concrete cases.

     20 C.F.R. s 718.201(c), 725.309(d):  Section 718.201(c) states
that pneumoconiosis is "recognized as a latent and progres-
sive disease which may first become detectable only after the
cessation of coal mine dust exposure."  Appellants argue that


this regulatory statement is impermissibly retroactive, be-
cause the question whether pneumoconiosis is latent and
progressive is unsettled.  This contention is based on a false
reading of the rule.

     Appellants acknowledge that at least one rare type of
pneumoconiosis is both latent and progressive, but argue that
the more common "simple pneumoconiosis" is not.  Br. for
Appellants at 17.  During oral argument, the Secretary con-
ceded that the most common forms of pneumoconiosis are not
latent.  Moreover, the Secretary acknowledged that latent
and progressive pneumoconiosis is rare, occurring in a small
percentage of cases by all accounts.  Tr. of Oral Arg. at 52-55. 
Nothing in the disputed rule says otherwise.  The rule simply
prevents operators from claiming that pneumoconiosis is nev-
er latent and progressive.  The medical literature makes it
clear that pneumoconiosis may be latent and progressive, and
appellants do not dispute this point.

     NMA's concern about the definition of pneumoconiosis as
latent and progressive is tied to the fact that, under 20 C.F.R.
s 725.309(d), a claimant whose claim was previously denied
may file a subsequent claim.  The subsequent claim will be
denied unless the claimant demonstrates that one of the
applicable conditions of entitlement has changed since the
claim was denied.  Id.  The "applicable condition" must be
one of the conditions on which the claim was denied in the
first place.  Id. s 725.309(d)(2).  Thus, a miner who was
originally found not to suffer from black lung disease may file
again if he develops the disease subsequently.  Any such
claimant, however, must still prove that he now has pneumo-
coniosis and that his disease arose out of employment in coal
mines.

     On its own, s 725.309(d) is not retroactive.  First, it applies
only to claims filed after the regulations' effective date and
has no application to pending subsequent claims.  See id.
s 725.2(c).  In any event, the new regulation, in relevant part,
mirrors the prior s 725.309(d), which provided that a subse-
quent claim will be denied unless the deputy commissioner
determines that "there has been a material change in condi-


tions."  20 C.F.R. s 725.309(d) (2000).  Counsel acknowl-
edged at oral argument that, under the old regulatory regime,
a claimant who had been denied benefits could reapply when
relevant conditions changed.  Tr. of Oral Arg. at 39.  The
new rule does not allow anything more.  Because it is not
substantively new, it does not change the legal landscape.

     Nor is s 725.309(d) retroactive in combination with the rule
recognizing that pneumoconiosis can be latent and progres-
sive.  While appellants express concern that the regulations
allow claimants to relitigate old claims under an irrebuttable
presumption that the miners' pneumoconiosis is progressive,
the rules afford no such presumption.  The fundamental
requirement that the claimant must prove a change in a
relevant condition (such as whether he developed pneumoco-
niosis after his claim was denied) has not changed.  A miner
will only be successful in his subsequent claim if he has
actually developed pneumoconiosis or another relevant condi-
tion of entitlement in the interim.

     20 C.F.R. s 718.204(a):  The "total disability rule" provides
that nonpulmonary diseases that "cause[ ] an independent
disability unrelated to the miner's pulmonary or respiratory
disability, shall not be considered in determining whether a
miner is totally disabled due to pneumoconiosis."  The con-
tested language does not appear in the prior version of the
regulation.  We find that the rule is retroactive as applied to
pending cases, because it changes the legal landscape in a
way that is likely to affect liability determinations.

     NMA contends that the rule's purpose and effect is to
overrule a Seventh Circuit decision in Peabody Coal Co. v.
Vigna, 22 F.3d 1388 (7th Cir. 1994).  The record supports this
suggestion.  See 62 Fed. Reg. at 3344-45 (stating that the
new regulation "makes clear the Department's disagreement
with the holding in [Vigna]" and was "designed to ensure that
the Seventh Circuit's view will not be applied outside that
circuit to cases arising under part 718").  The District Court
held that the regulation codified existing law and the Secre-
tary's prior interpretation.  NMA, 160 F. Supp. 2d at 67-68
(citing many cases and adding a "But see" citation to Vigna).


     In Vigna, a miner who had mined for forty years suffered a
stroke and became totally disabled.  22 F.3d at 1390.  The
miner was also a longtime smoker.  Id.  The Seventh Circuit
held, contrary to the ALJ's finding, that the coal company
successfully rebutted the presumption that the miner's dis-
ability arose from his coal mine employment.  Id. at 1394. 
The court found that the evidence left no doubt that the
miner's employment did not contribute to his stroke, which
was the cause of his total disability.  Id.  At the time of the
stroke, there was no evidence that the miner had pneumoco-
niosis.  Id.

     Under the new rule, the adjudicator would not be able to
consider a nonpulmonary condition (such as a stroke) at all in
determining whether the miner was totally disabled due to
pneumoconiosis.  Instead, the adjudicator would have to de-
termine whether the miner was totally disabled due to pneu-
moconiosis without considering his unrelated, nonpulmonary
disability.  The new regulation thus changes the legal land-
scape by precluding adjudicators from considering unrelated
medical disabilities, reversing the rule in the Seventh Circuit,
and precluding any other circuit from adopting the Seventh
Circuit's interpretation.  It cannot be said to be merely
"procedural," because it has a direct effect on the determina-
tion of liability.

     In finding the rule to be impermissibly retroactive as
applied to pending cases, we do not, of course, intend to affect
the law in circuits that have adopted or might adopt positions
that conform with the Secretary's interpretation.  See, e.g.,
Cross Mountain Coal, Inc. v. Ward, 93 F.3d 211, 217 (6th Cir.
1996) (holding that "the fact that claimant may, or may not,
also be disabled by a back injury is not grounds for denying
his claim for benefits").  Instead, the effect of our ruling is to
leave the state of the law on this question exactly as it was
prior to the regulations' promulgation for cases that had
already been filed when the regulations were promulgated.

     20 C.F.R. s 725.701:  The rule embodied in s 725.701 cre-
ates a rebuttable presumption that when a miner who is
eligible for black lung benefits receives medical treatment for


a pulmonary disorder, the disorder is "caused or aggravated
by the miner's pneumoconiosis."  20 C.F.R. s 725.701(e). 
The employer may rebut the presumption with "credible
evidence that the medical service or supply provided was for
a pulmonary disorder apart from those previously associated
with the miner's disability" or was beyond the treatment
necessary to treat the covered disorder, or "was not for a
pulmonary disorder at all."  Id.  The regulation codifies the
so-called Doris Coal presumption, named for a Fourth Circuit
case that adopted the presumption before it was included in
the new regulations.  See Doris Coal Co. v. Director, OWCP,
938 F.2d 492, 496-97 (4th Cir. 1991) ("Since most pulmonary
disorders are going to be related or at least aggravated by
the presence of pneumoconiosis, when a miner receives treat-
ment for a pulmonary disorder, a presumption arises that the
disorder was caused or at least aggravated by the miner's
pneumoconiosis, making the employer liable for the medical
costs.").  The Fourth Circuit later reaffirmed and clarified
the presumption, using language that was mirrored in the
new regulation.  See Gulf & W. Indus. v. Ling, 176 F.3d 226,
233 (4th Cir. 1999) (holding that the employer can rebut the
presumption by producing "credible evidence that the treat-
ment rendered is for a pulmonary disorder apart from those
previously associated with the miner's disability, or is beyond
that necessary to effectively treat a covered disorder, or is
not for a pulmonary disorder at all").

     NMA argues that the regulation codifying the judicial
presumption is retroactive as applied to pending cases, and
we agree.  The rule is not reflected in the prior regulation,
even though it may reflect the Secretary's longstanding poli-
cy.  See Doris Coal, 938 F.2d at 496-97.  Moreover, the rule
contradicts the Sixth Circuit's holding in Glen Coal Co. v.
Seals, 147 F.3d 502 (6th Cir. 1998).  In that case, the court
held that the Doris Coal presumption is permissible under
the APA, because it only reallocates the burden of production,
not the burden of proof.  Id. at 512-13.  Nonetheless, the
court struck down the presumption as inconsistent with Sixth
Circuit law, in part because it found that the creation of such
judicial presumptions ran afoul of the BLBA's statutory goal


of uniformity.  Id. at 513-14 (citing Director, OWCP v. Green-
wich Collieries, 512 U.S. 267 (1994)).  The regulation changes
the outcome for cases that have already been filed in the
Sixth Circuit and any other circuit that would have rejected
Doris Coal.  Our holding is, of course, not intended to affect
the law in the Fourth Circuit or any other circuit that would
have embraced the Doris Coal presumption.  That judicial
presumption remains the law in the circuits that adopt it. 
Our holding simply prevents the Secretary from imposing the
presumption, in the form of a new regulation, on all of the
other circuits for cases that were filed before the regulations
were promulgated.

     20 C.F.R. s 725.101(a)(6):  The rule propounded in
s 725.101(a)(6) defines "benefits" to include any expenses
related to the medical examination and testing authorized
pursuant to s 725.406, which requires the Department of
Labor to provide each applicant for benefits with a pulmonary
evaluation at no expense to the miner.  The new
s 725.101(a)(6) conforms the regulatory definition of "bene-
fits" to s 725.406, both the old and new versions.  The prior
version of s 725.406(c) already provided that the cost of the
medical examination would be paid by the Fund and that the
Fund would be reimbursed "by an operator, if any, found
liable for the payment of benefits to the claimant."  20 C.F.R.
s 725.406(c) (2000).  Likewise, the new s 725.406(e) provides
that the cost of the medical examination will be paid by the
Fund and that the Fund will be reimbursed "by an operator,
if any, found liable for the payment of benefits to the claim-
ant."

     NMA argues that s 725.101(a)(6) retroactively shifts to the
employer the cost of the medical examination provided under
s 725.406.  NMA recognizes that the cost always has been
shifted under s 725.406 when an operator is found liable for
the payment of benefits.  Its challenge is based on the
misperception that the new rule shifts the cost of the medical
examination even when the miner does not prevail.  This is
incorrect.  The cost shifts to the employer only when "bene-
fits" are awarded.  When no benefits are awarded, the cost of
the examination presumably will continue to be paid by the


Fund, as set forth in s 725.406.  Appellants have not pointed
to anything in the new definition that departs from the
system already in place under the old s 725.406(c).  Thus, the
new definition changes nothing and is not impermissibly
retroactive.

     20 C.F.R. s 725.101(a)(31):  The rule in s 725.101(a)(31)
provides that "[a] payment funded wholly out of general
revenues shall not be considered a payment under a workers'
compensation law."  This provision is significant because the
benefits payable under the BLBA must be offset by any
amount the miner receives for his black lung disability under
a state or federal workers' compensation law.  See 30 U.S.C.
s 932(g).  NMA agrees that the new rule reflects prior
agency practice, but argues that it is nonetheless retroactive
as applied to pending cases because at least one Court of
Appeals has rejected the agency's practice.  We agree.

     In Director, OWCP v. Eastern Associated Coal Corp., 54
F.3d 141 (3d Cir. 1995), the Third Circuit declined to defer to
the Director of the OWCP's policy of not reducing a miner's
BLBA benefits by the amount that he received from general
revenues under a state occupational disease compensation act. 
The court agreed that the statutory reference to "workers'
compensation law" was ambiguous.  However, the old regula-
tion said nothing about payments funded out of general
revenues, so the court declined to exclude workers' compensa-
tion payments funded out of general revenues.  Id. at 147-49; 
20 C.F.R. s 725.101(a)(4) (2000).  The court suggested that
the Secretary rewrite the regulations to achieve the agency's
regulatory goal.  Id. at 149.  This is exactly what the Secre-
tary did in promulgating 20 C.F.R. s 725.101(a)(31).  It would
be impermissibly retroactive, however, to apply the new
regulation to claims that were already pending when the new
regulation took effect.  It would also be retroactive to apply
the regulation to adjust the payments being made on settled
or resolved claims.  Of course, other circuits remain free to
apply the Secretary's longstanding interpretation of the prior
regulation to pending claims.  The regulation is not imper-
missibly retroactive as applied to claims filed after the regula-
tions' effective date.


     20 C.F.R. ss 725.204, 725.212(b), 725.213(c), 725.214(d),
725.219(c), (d):  These regulations, as applied to claims other
than those filed after the regulations' effective date, are
impermissibly retroactive, because they expand the scope of
coverage by making more dependents and survivors eligible
for benefits.  For example, the new s 725.204 describes
criteria for determining whether a claimant qualifies for
augmented benefits as a miner's spouse.  The new version of
the regulation eliminates a provision in the prior version that
essentially prevented a miner from having more than one
qualifying spouse for purposes of augmented benefits.  Com-
pare 20 C.F.R. s 725.204(a)(4) with 20 C.F.R. s 725.204(d)(1)
(2000).  Similarly, under the new 20 C.F.R. s 725.212(b) and
s 725.214(d), a miner could have more than one surviving
spouse if he divorced and remarried during the pertinent
period.  Sections 725.209 and 725.219 address the determina-
tion of the miner's dependent children.  Section 725.213(c)
provides that a surviving spouse or surviving divorced spouse
whose entitlement to benefits is terminated because she
remarries may thereafter again become entitled to benefits,
either by divorcing or through the death of her successor
spouse.

     The Secretary recognizes that the new definitions expand
the scope of liability, but defends the expansion as necessary
to conform to the 1990 amendments to the Social Security
Act, portions of which are incorporated into the BLBA.  See
30 U.S.C. s 902(a)(2), (e) (incorporating various Social Securi-
ty Act definitions found at 42 U.S.C. s 416).  The District
Court agreed, holding that the revisions "bring the regula-
tions into conformity with changes made by Congress in 1990
to the" Social Security Act's definitions of "dependent wife"
and other key terms.  NMA, 160 F. Supp. 2d at 69.

     The Secretary's position as to the new provisions' applica-
tion remains unclear.  In its brief, the Secretary suggests
that the expanded definitions apply to all BLBA claims filed
after the 1990 amendments to the Social Security Act.  Pre-
sumably, this could even affect payments made on claims that
were finally adjudicated before the new regulations were
promulgated.  In a post-hearing chart submitted pursuant to


an order of this court, the Secretary stated that the provi-
sions would apply to all claims pending on the new regula-
tions' effective date, as well as to claims filed after that date,
and to all benefit payments made after that date, including
still-open claims filed on or after, or pending on, August 18,
1978.  See also 20 C.F.R. s 725.2 (setting forth the applicabil-
ity of the provisions).

     In either case, we hold that it would be unlawfully retroac-
tive to apply the definitions to any claims other than those
filed on or after the regulations' effective date.  Before the
effective date, mine operators had no notice of the new
definitions, for they were never incorporated in the old regu-
lations.  The Secretary and intervenors contend that the
Secretary had changed the functional definitions as early as
1994 to conform with the 1990 Social Security Act amend-
ments, by changing the Department of Labor's procedural
manual.  Tr. of Oral Arg. at 80-84.  There are two problems
with this argument.  The first is that counsels' citation to the
record does not bear out the claim.  Counsel cited 65 Fed.
Reg. 79,964 in support of the argument that the Secretary
had already adopted these new definitions as far back as
1994.  But the cited page states only that, since 1994, the
Secretary's procedure manual has provided that when a sur-
viving spouse and a surviving divorced spouse both qualify,
each is entitled to full benefits.  This citation does not
address the other challenged regulations, such as those deal-
ing with surviving children and those addressing surviving
spouses who become ineligible and then become eligible
again.  The second problem is that the Secretary's prior
practice was encapsulated only in a manual, not in a regula-
tion promulgated pursuant to notice-and-comment rulemak-
ing.  There is nothing to indicate that the cited manual
purported to state substantive rules or that it was generally
known by and available to regulated parties.  The Secretary
cannot bind parties to substantive rules of which they had no
notice.

     The Secretary argues that application of the revised defini-
tions to all claims filed after the 1990 amendment date is
merely a correct application of the law in effect since that


time.  The Secretary relies on Regions Hospital v. Shalala,
522 U.S. 448, 456 (1998), in which the Court held that the
government's reaudit rule was not impermissibly retroactive
because it merely called for the correct "application of the
cost-reimbursement principles in effect" when the costs were
incurred.  By contrast, the instant regulations would actually
change the scope of liability for claims that were filed at a
time when these rules were not in effect.  The decision in
Regions Hospital does not support an argument that the
Secretary may apply newly updated regulations retroactively
to pending claims that were initiated before the change. 
Claims that have been resolved or settled, and claims that
were filed after the effective date of the new rules, are not
affected by this holding.

C.   Substantive Challenges

     In considering NMA's challenges to the revised regulations,
we are guided by well-accepted principles of administrative
law.  To the extent NMA argues that the regulations conflict
with the statute, we begin by asking whether "Congress has
directly spoken to the precise question at issue.  If the intent
of Congress is clear, that is the end of the matter;  for the
court, as well as the agency, must give effect to the unambig-
uously expressed intent of Congress."  Chevron, U.S.A., Inc.
v. Natural Res. Def. Council, 467 U.S. 837, 842 (1984).  If,
however, "the statute is silent or ambiguous with respect to
the specific issue," we defer to the agency's reasonable con-
struction of that statute.  Id. at 843.  As for NMA's arbitrary
and capricious challenges, we will uphold the regulations as
long as they "conform to certain minimal standards of ration-
ality."  Small Refiner Lead Phase-Down Task Force v. EPA,
705 F.2d 506, 521 (D.C. Cir. 1983) (citation and internal
quotation marks omitted).  Though agencies have a duty of
reasoned decisionmaking, see Motor Vehicle Mfrs. Ass'n v.
State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983), we
"presume the validity of agency action," Kisser v. Cisneros,
14 F.3d 615, 618 (D.C. Cir. 1994), and may vacate only if the
regulation is unsupported by substantial evidence, or if the
agency has made a clear error in judgment, see Citizens to
Preserve Overton Park v. Volpe, 401 U.S. 402, 415-16 (1971). 


We give particular deference to an agency's promulgation of
evidentiary rules governing its own adjudications;  the agen-
cy's defense of those regulations need only be "reasonable" so
long as they are not "inconsistent with a federal statute,"
such as the APA. Chem. Mfrs. Ass'n v. Dep't of Transp., 105
F.3d 702, 706 (D.C. Cir. 1997).  Finally, to the extent NMA
argues that where, as here, we consider a challenge to a
recently promulgated regulation, "[i]t is not uncommon ...
that ... the meaning of the disputed provisions does not
appear clearly until the case is before the courts of appeals. 
We typically accept the agency's construction - which often
eliminates or narrows the dispute - because we recognize the
agency is entitled to deference as to the meaning of its own
regulation."  Nat'l Mining Ass'n v. Babbitt, 172 F.3d 906, 911
(D.C. Cir. 1999).  And in such cases, that construction may be
expressed in the agency's brief or even at oral argument.

     With these standards in mind, we consider each section of
the revised regulations challenged by NMA.

     Pneumoconiosis Definition

     As revised, s 718.201(a) largely repeats the pneumoconiosis
definition contained in the regulation's prior version but
divides that definition into two groups, "clinical" pneumoconi-
osis ("those diseases recognized by the medical community as
pneumoconiosis") and "legal" pneumoconiosis ("any chronic
lung disease or impairment ... arising out of coal mine
employment").  Compare 20 C.F.R. s 718.201 (2000) with 20
C.F.R. s 718.201(a) (2001).  This revision merely adopts a
distinction embraced by all six circuits to have considered the
issue, see, e.g., Ling, 176 F.3d at 231-32;  see also 65 Fed.
Reg. at 79,938 (citing six circuit court cases), and, contrary to
NMA's repeated assertions, neither "expand[s]" nor "rede-
fine[s]" the meaning of pneumoconiosis beyond its statutory
definition, Br. for Appellants at 38.  Even if the regulation
could be read to change the definition, the Black Lung
Benefits Act broadly invests the Secretary with authority not
only to write regulations defining "total disability," 30 U.S.C.
s 902(f)(1) - which in turn depends on the definition of


pneumoconiosis - but also to supplement statutory terms "as
[s]he deems necessary," id. s 932(a).

     NMA also argues that another part of the pneumoconiosis
definition, section 718.201(c), defining pneumoconiosis as a
"latent and progressive disease which may first become de-
tectable only after the cessation of coal mine dust exposure,"
lacks support in the administrative record and is thus arbi-
trary and capricious.  In support of this argument, NMA
points to record evidence indicating that pneumoconiosis is
latent and progressive in - at most - eight percent of cases. 
See P.T. Donnan, et al., Progression of Simple Pneumoconio-
sis in Ex-Coalminers After Cessation of Exposure to Coal-
mine Dust iv (Inst. of Occupational Medicine, December
1997).  We would thus sustain NMA's challenge to section
718.201(c) if the regulation said that pneumoconiosis is "al-
ways" or "typically" a latent and progressive disease.  Al-
though the regulation could be so read - "pneumoconiosis is
recognized as a latent and progressive disease" - the remain-
ing language provides that the disease "may first become
detectable only after the cessation of coal mine dust expo-
sure."  The Secretary resolved this ambiguity at oral argu-
ment.  Asked whether her "position is [that the] regulation
simply states [pneumoconiosis] can be a progressive and
latent disease," counsel answered "that's correct."  Tr. of
Oral Arg. at 54.  In light of this narrowing construction, we
conclude that the record evidence of the disease's latency and
progressivity - which also includes a study (not explicitly
relied on by the government in its brief) indicating that
pneumoconiosis is latent and progressive as much as 24% of
the time, see 62 Fed. Reg. 3338, 3344 (Jan. 22, 1997) (citing
studies) - is sufficient to support section 718.201(c).

     Change in Condition Rule

     Revised s 725.309(d) governs the circumstances under
which miners may file a claim after denial of an earlier claim. 
The prior regulation allowed such claims only upon proof of
"a material change in conditions," 20 C.F.R. s 725.309(d)
(2000), while the revised regulation requires "the claimant [to]
demonstrate[ ] that one of the applicable conditions of entitle-


ment has changed," 20 C.F.R. s 725.309(d) (2001).  NMA's
assertion that the revised rule is arbitrary and capricious
because it "requires no exacting proof of materially changed
conditions," Br. for Appellants at 40, and creates an "irrebutt-
able presumption" that a claimant has pneumoconiosis, id. at
46, finds no support in the regulation's language.  The re-
vised rule actually places the burden of proof squarely on the
claimant to prove a change in condition, stating that "the
claim shall be denied unless the claimant demonstrates that
one of the applicable conditions of entitlement ... has
changed."  20 C.F.R. s 725.309(d) (2001).  Nor do we find
convincing NMA's related argument that the revised regula-
tion "waives res judicata or traditional notions of finality," Br.
for Appellants at 45, as the Secretary has interpreted the
regulation to permit new claims based only on the claimant's
current condition and to preclude the admission of any evi-
dence that existed at the time the previous claim was denied,
see Br. for Appellees at 31.

     Treating Physician Rule

     A new rule, s 718.104(d) establishes that in determining
whether a successful claimant's subsequent treatment for a
pulmonary disorder is "compensable, the opinion of the min-
er's treating physician may be entitled to controlling weight." 
The rule is not mandatory.  Instead, it permits ALJs to
accord controlling weight to a treating physician's opinion if
that opinion is "based on the credibility of the physician's
opinion in light of its reasoning and documentation, other
relevant evidence and the record as a whole."  20 C.F.R.
s 718.104(d)(5).

     According to NMA, the revised rule impermissibly shifts
the burden of proof from claimant to employer.  In support of
this argument, NMA relies on Greenwich Collieries, where
the Supreme Court held that absent specific statutory autho-
rization, agencies may not informally create rules that sup-
plant the APA's requirement that "the proponent of a rule or
order has the burden of proof."  512 U.S. at 269-71 (quoting 5
U.S.C. s 556(d)).  Greenwich Collieries, however, is inappli-
cable here, for neither the revised regulation's plain language


nor the Secretary's interpretation, see Br. for Appellees at 38,
relieves claimants of the burden of proving both pneumoconi-
osis and the credibility of the doctor's opinion.  Indeed, the
Secretary points out that this regulation does not even "ad-
dress which party bears the burden of proving the proposition
to which the medical opinion evidence relates."  Br. for
Appellees at 38 (citing 65 Fed. Reg. at 79,933-34).  Equally
without merit is NMA's related argument that the treating
physician rule is invalid because it "treats proof differently"
by unfairly advantaging claimants' evidence;  NMA even sug-
gests that the rule enables doctors to help claimants obtain
benefits fraudulently by "exaggerating" the extent of claim-
ants' illnesses.  Br. for Appellants at 34.  This argument
assumes that ALJs will automatically give controlling weight
to treating physicians' opinions, yet the regulation actually
places limits on their capacity to do so.  See 20 C.F.R.
s 718.104(d)(5) (permitting reliance on treating physician tes-
timony only where physician's opinion is credible and consis-
tent with record evidence).  The requirement that a treating
physician's opinion be credible, moreover, largely eliminates
any risk of fraud.

     Arguing that the treating physician rule is also arbitrary
and capricious, NMA claims that "[t]here is no scientific or
medical reason to conclude that a treating physician has
clearer insight into any medical question that might arise in a
black lung claim than a pulmonary specialist or any other
doctor."  Br. for Appellants at 35.  In support of this argu-
ment, NMA cites record evidence suggesting that "there is a
significant likelihood that a treating physician will use decep-
tion to assist patients in obtaining third party paid benefits." 
Cmts. of the Nat'l Mining Ass'n at 44 (1/6/2000), reprinted at
J.A. 2231.  Yet the agency considered and rejected this
allegation, convincingly pointing out that the claim could "as
easily be directed toward any party-affiliated physician, or
group of such physicians, who may benefit by tailoring conclu-
sions to fit the interests of the party paying for the medical
opinion."  65 Fed. Reg. at 80,024;  see also State Farm, 463
U.S. at 51-54 (holding that an agency's duty of reasoned


decisionmaking includes the requirement to explain away
contrary evidence) and, e.g., id. at 52 ("Rescission of the
[safety restraint] requirement would not be arbitrary and
capricious merely because there was no evidence in direct
support of the agency's conclusion.").

     Hastening Death Rule

     The Secretary revised s 718.205(c)(5) to state that "pneu-
moconiosis is a substantially contributing cause of a miner's
death if it hastens the miner's death."  Calling the rule
arbitrary and capricious, NMA says "there is no science to
support" a hastening death rule in the case of a death caused
by a non-respiratory condition.  Br. for Appellants at 50. 
The regulation, however, nowhere mandates the conclusion
that pneumoconiosis be regarded as a hastening cause of
death, but only describes circumstances under which a has-
tening-cause conclusion may be made.  Moreover, it expressly
requires claimants to prove that pneumoconiosis is the has-
tening cause.  The fact that pneumoconiosis may, as NMA
asserts, rarely or never hasten death primarily caused by
other diseases does not undermine the regulation;  it merely
means that few or no claimants will succeed on the theory
that black lung disease hastened death from other causes.

     In any event, the record contains medical testimony indi-
cating that "impairment of lung function from pneumoconiosis
[can] weaken the body's defenses to infections and increase
susceptibility to other disease processes."  65 Fed. Reg. at
79,950 (discussing testimony of Dr. Robert Cohen, Chief of
the Division of Pulmonary Medicine, Cook County (IL) Hospi-
tal).  Although NMA cites two medical studies suggesting
contrary conclusions, see J.A. 1167, 2468, the Secretary con-
sidered this evidence and gave plausible reasons for rejecting
it, noting that both studies focused on the narrower medical
definition of pneumoconiosis rather than the broader legal
one, and that one of the studies concluded only that hastening
death was rare but "did not rule it out as a medical possibili-
ty," 65 Fed. Reg. at 79,951.  In light of all this, we think it
obvious that the Secretary has successfully discharged her
duty of reasoned decisionmaking.


     Operator Liability Rules

     Section 725.408 establishes a deadline for coal mine opera-
tors to submit evidence if they disagree with their designation
as parties potentially liable for a miner's claim, while
s 725.495(c) provides that once an operator has been deter-
mined to be responsible for a claim, that operator may be
relieved of liability only if it proves both that it is financially
incapable of assuming liability and that another operator that
more recently employed the miner is financially capable of
doing so.  Again relying on Greenwich Collieries, NMA ar-
gues that the revised rules "relieve the agency of its normal
burden to identify the correct responsible party" and shift
that burden onto coal mine operators in violation of the APA's
requirement that proponents of an order sustain the burden
of proof.  Br. for Appellants at 62.  NMA misreads both
revised regulations.  Section 725.408 shifts the burden of
production, not the burden of proof;  it requires nothing more
than that operators must submit evidence rebutting an asser-
tion of liability within a given period of time.  Greenwich
Collieries carefully distinguishes agency regulations that shift
the burden of proof (prohibited by the APA "except as
otherwise provided by statute," 5 U.S.C. s 556(d)) from regu-
lations that shift the burden of production (which the APA
does not prohibit, see 512 U.S. at 270-80 (distinguishing
burden of proof from burden of production)).  NMA argues
that s 725.495(c) nevertheless violates Greenwich Collieries
because it "reliev[es] the agency of its natural burden of
proving the identity of the correct responsible party."  Br. for
Appellants at 64.  The regulation, however, shifts the burden
of proof only to the "designated responsible operator," 20
C.F.R. s 725.495(c);  i.e., it applies only to the extent that a
claimant has already carried his burden of proving that an
operator is liable.  "In seeking to be excused from liability,"
the District Court explained, "the operator becomes the 'pro-
ponent' of a remedial order of the ALJ and, therefore, the
party to which [the APA] assigns the burden of proof."  Nat'l
Mining Ass'n v. Sec'y of Labor, No. 00-3086, slip op. at 52
(D.D.C. Aug. 9, 2001);  see also Greenwich Collieries, 512 U.S.
at 278.


     NMA argues that s 725.495(c) is also arbitrary and capri-
cious because it rests on the premise that "employers and
carriers are better situated to identify and prove an alterna-
tive liable party."  Br. for Appellants at 64.  As the Secretary
points out, however, s 725.495(c) is not based on that pre-
sumption.  See 65 Fed. Reg. at 80,008-09 (discussing
s 725.495(c) but nowhere mentioning the rationale that mine
operators and insurance carriers have superior access to
information about miners' subsequent employment).  Al-
though the Secretary offers little in the way of positive
support for the rule, s 725.495(c) - an evidentiary rule - need
only be "reasonable" and not "inconsistent with a federal
statute" to survive review.  Chem. Mfrs. Ass'n, 105 F.3d at
706.  Where, as here, the Secretary affords a mine operator
liable for a claimant's black lung disease the opportunity to
shift liability to another party, it is hardly irrational to
require the operator to bear the burden of proving that the
other party is in fact liable.

     Medical Benefits Rule

     The Secretary's revision of s 725.201(e) creates a presump-
tion that any pulmonary disorder for which a miner receives
treatment after successfully filing a BLBA claim is caused by
that miner's pneumoconiosis.  The new regulation allows the
operator to rebut this presumption with credible evidence
that the disorder was not pulmonary, the disorder was unre-
lated to the miner's pneumoconiosis, or the treatment the
miner received was unnecessary.

     Claiming that the medical benefits rule "shifts the burden
to the employer to disprove medical coverage," Br. for Appel-
lants at 52, NMA argues it too runs afoul of Greenwich
Colleries.  Although the regulation could be so read, the
Secretary explains that it shifts only the burden of produc-
tion to operators to produce evidence that the treated disease
was unrelated to the miner's pneumoconiosis;  the ultimate
burden of proof remains on claimants at all times.  See 65
Fed. Reg. at 80,022 (explaining that "invocation" of the pre-
sumption "shifts only the burden of production, not persua-
sion");  see also Ling, 176 F.3d at 233-34 (holding that an


identical "presumption merely reallocates the burden of pro-
duction, and does not affect the burden of proof");  Seals, 147
F.3d at 512 (same).

     NMA argues that the medical benefits rule is also arbitrary
and capricious, pointing to a comment claiming that "[w]hen a
miner receives a medical service or supply for a pulmonary
disorder, it is not reasonable to assume that the disorder is
caused or aggravated by pneumoconiosis."  Cmts. of Gregory
J. Fino, M.D., and Barbara J. Bahl, Ph.D. at 11 (1/4/2000),
reprinted at J.A. 2439.  Carefully considering this comment,
however, the Secretary rejected it because the comment
failed to distinguish between medical pneumoconiosis and the
much broader legal definition of the disease.  See 65 Fed.
Reg. at 80,023.  As the Secretary points out, there is a clear
rational relationship between the fact proved (that a miner
suffered from totally disabling pneumoconiosis in the past)
and the fact presumed (that the miner's treated pulmonary
disorder is related to that pneumoconiosis);  this suffices for
purposes of our review.

     Total Disability Rule

     An entirely new provision, s 718.204(a) states that "any
nonpulmonary or nonrespiratory condition or disease, which
causes an independent disability unrelated to the miner's
pulmonary or respiratory disability, shall not be considered"
in determining a miner's total disability under the BLBA. 
According to NMA, the rule runs counter to the proposition
that parties may submit all relevant evidence in support of
their position.  See 30 U.S.C. s 923(b).  This argument,
however, ignores the BLBA's clear grant of authority to the
Secretary to establish the medical criteria for adequate proof
of "total disability."  Id. s 902(f)(1)(D).  And contrary to
NMA's claim that "DOL's rule excludes relevant evidence for
no good reason," Br. for Appellants at 48, we see an obvious
rational basis for the rule:  the statute only pertains to
whether a miner is disabled "due to pneumoconiosis," and
evidence of nonpulmonary conditions has no relevance to that
inquiry.  Indeed, three circuits have adopted just this reading
of the Act.  See 65 Fed. Reg. at 79,947 (citing cases from


Sixth, Seventh, and Tenth Circuits).  But see Vigna, 22 F.3d
at 1394-95.

     Challenging the total disability rule as arbitrary and capri-
cious, NMA claims that the regulation "is supported only by
an intent to reverse" the Seventh Circuit's decision in Pea-
body Coal v. Vigna, which held that a miner totally disabled
due to a nonpulmonary ailment could not be compensated
under the Black Lung Benefits Act.  See id.  NMA's asser-
tion regarding intent is irrelevant:  no authority supports the
proposition that a rule is arbitrary and capricious merely
because it abrogates a circuit court decision.  Quite to the
contrary, "regulations promulgated to clarify disputed inter-
pretations of a regulation are to be encouraged.  Tidying-up a
conflict in the circuits with a clarifying regulation permits a
nationally uniform rule without the need for the Supreme
Court to essay the meaning of every debatable regulation." 
Pope v. Shalala, 998 F.2d 473, 486 (7th Cir. 1999) (citation
and internal quotation marks omitted).

     NMA also claims that the total disability rule "is contrary
to all of the medical testimony," Br. for Appellants at 49, but
points only to record evidence generally indicating that evi-
dentiary restrictions are "inconsistent with good medical
practice," Cmts. of Drs. Fino and Bahl at 4, reprinted in J.A.
2432, evidence far too vague to supply any basis for conclud-
ing that the total disability rule is arbitrary and capricious. 
The revised regulation has a rational basis and is consistent
with the APA;  that is enough.

     Evidence Limitation Rules

     NMA next argues that nothing in the APA authorizes the
revised regulations (ss 725.310(b), 725.414, 725.456,
725.457(d), and 725.458) setting limits on the amount and
timing of evidence admissible in benefits determinations, be-
cause that statute "authorizes each party to submit whatever
evidence that party thinks is needed to prove its case or
defense."  Br. for Appellants at 56.  NMA's theory - that the
APA permits introduction of unlimited amounts of evidence -
is flatly contradicted by the statute itself, which empowers
agencies to "exclu[de] ... irrelevant, immaterial, or unduly


repetitious evidence" as "a matter of policy," 5 U.S.C.
s 556(d), as well as the Black Lung Benefits Act, which
authorizes the Secretary to issue regulations "provid[ing] for
the nature and extent of the proofs and evidence and the
method of taking and furnishing the same in order to estab-
lish the rights to benefits," 30 U.S.C. s 923(b) (incorporating
42 U.S.C. s 405(a)).  Nor do the revised rules set inflexible
limits, as NMA claims.  On the contrary, the rules give ALJs
discretion to hear additional evidence for "good cause," 20
C.F.R. s 725.456(b)(1).

     NMA claims that the evidence-limiting rules are also arbi-
trary and capricious because they are unsupported by medical
evidence.  NMA bases this claim on a commenter's argument
that "it is unreasonable to artificially limit" the amount of
evidence heard in benefits determinations.  Cmts. of Drs.
Fino and Bahl at 4, reprinted in J.A. 2432.  Other record
evidence, however, indicates that the new evidentiary limits
are not at all "artificial[ ]," but - as the Secretary explained -
will enable ALJs to focus their attention "on the quality of the
medical evidence in the record before [them]."  64 Fed. Reg.
at 54,994.  The record also makes clear the need for evidence
limitations;  in their absence, lawyers often waste ALJs' time
and resources with excessive evidence - in one case, a mine
operator's lawyer submitted eighty-nine separate X-ray re-
readings from fourteen different experts.  Cmts. of Robert
Cohen at 71 (6/19/1997), reprinted in J.A. 1381.  At oral
argument, moreover, NMA conceded that ALJs have always
had discretion to exclude evidence in precisely the manner
outlined by the new evidence-limiting rules;  it would be
strange indeed to conclude that the Secretary acted arbitrari-
ly and capriciously by codifying evidentiary limits that ALJs
have always had the discretion to impose.

     Dependency Rules

     The Black Lung Benefits Act incorporates the Social Secu-
rity Act's definition of "dependent."  See 30 U.S.C. s 902(a)
(incorporating the Social Security Act's definition of "depen-
dents").  These regulations (ss 725.204, 725.213(c), 725.214,
725.219(d)) broaden the definition of "dependent" to track


more closely recent revisions of the incorporated Social Secu-
rity Act provisions.  Like the District Court, though, we
decline to consider this claim, because NMA failed to raise it
during the notice-and-comment period.  See, e.g., Nat'l Wild-
life Fed'n v. EPA, 286 F.3d 554, 562 (D.C. Cir. 2002) ("It is
well established that issues not raised in comments before the
agency are waived and this Court will not consider them."). 
NMA points out that it argued before the agency that "Con-
gress did not intend to treat the black lung program as a
social safety net," Br. for Appellants at 69, but this general
claim falls well short of providing the agency with the re-
quired "adequate notice" of NMA's specific claim.  Nat'l
Recycling Coalition, Inc. v. Reilly, 884 F.2d 1431, 1437 (D.C.
Cir. 1989).  Contrary to NMA's argument, moreover, this
notice requirement is not undermined by Darby v. Cisneros,
509 U.S. 137 (1993), and Sims v. Apfel, 530 U.S. 103 (2000). 
As we recently noted, Darby "addresses exhaustion of reme-
dies, not waiver of claims, and is thus wholly inapposite" to
the latter issue.  Nat'l Wildlife Fed'n, 286 F.3d at 562.  Sims
is equally inapplicable, for it addresses issue exhaustion, not
issue waiver.

     Attorney's Fee Rule

     Section 725.366(b) provides that in calculating attorney's
fees that are shifted from claimant to mine operator, the ALJ
"shall take into account" a number of factors, including "the
quality of the representation, the qualifications of the repre-
sentative, [and] the complexity of the legal issues involved." 
In Burlington v. Dague, the Supreme Court held that shifted
attorney's fees must be calculated according to the "lodestar
method," which requires that such fees be determined by
multiplying reasonable time spent by the attorney's hourly
fee.  See 505 U.S. 557, 562 (1992).  Although the revised
regulation requires consideration of no factors not already
included in the lodestar analysis, NMA argues that the rule
will require ALJs to consider some factors more than once,
resulting in prohibited "double counting."  Br. for Appellants
at 67;  see Pennsylvania v. Delaware Valley City Council, 483
U.S. 711, 726 (1987).  Not only does nothing in the revised
regulation require such double counting, but the Secretary


interprets the regulation to mean that "the factors identified
in s 725.366(b) do not supplant the 'lodestar' method of
calculating reasonable fees, or enhance the lodestar fee once
it is calculated."  Br. for Appellees at 54.

     Cost and Expense Rules

     Section 725.101(a)(6) (the cost rule) expands the definition
of BLBA "benefits" to include "any expenses related to the
medical authorization."  As a result, employers now bear the
costs of successful claimants' medical examinations.  Section
725.459 (the expense rule) empowers ALJs in their discretion
to shift costs incurred by claimants' production of witnesses
to an employer, regardless of which party prevails.

     NMA rests its challenge to these regulations on the twin
premises that parties presumptively bear the costs of their
own litigation expenditures and that such costs may only be
shifted to the losing party pursuant to "specific statutory
authorization."  See W. Va. Univ. Hosp. v. Casey, 499 U.S. 83,
97-100 (1991).  The cost rule, however, finds just such "specif-
ic statutory authorization" in the Black Lung Benefits Act's
express authorization to "[t]he Secretary ... to charge the
cost of examination ... to the employer."  33 U.S.C. s 907(e).

     In support of the expense rule, the Secretary first cites 33
U.S.C. s 928(d), which permits her to shift attorney's fees. 
But that section of the Act authorizes fee-shifting only when
the claimant prevails, while the expense rule authorizes such
shifting for both successful and unsuccessful claimants.  Nor
does 30 U.S.C. s 907(e) provide an adequate source of author-
ity;  that clause only permits the Secretary to assign costs of
a single pulmonary examination - not any cost associated with
claimants' witnesses - to the employer.  The expense rule
thus lacks the "specific statutory authorization" for fee-
shifting required by Casey and is the one regulation that we
find invalid on its face.

                         III. Conclusion

     For the foregoing reasons, we affirm in part, reverse in
part, and remand to the District Court for further proceed-
ings consistent with this opinion.