Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-01-05278/USCOURTS-caDC-01-05278-0/pdf.json

Nature of Suit Code: 790
Nature of Suit: Other Labor Litigation
Cause of Action: 

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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 Justice, 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.

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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 remand the case to the Department of Labor for further

proceedings consistent with this opinion.

I. Background

The BLBA is a federally administered law providing benefits to coal miners who are totally disabled due to pneumoconiosis, 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 conditions that afflict a significant percentage of the nation's coal

miners with "severe, and frequently crippling, chronic respiratory 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 impairment 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.

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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 Director 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 before 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 proposed revisions to the rules governing the adjudication of

miners' claims under the BLBA. See Regulations Implementing 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 Occupational 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

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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, insurance companies, and the National Mining Association (collectively "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 arrangements); 20 C.F.R. Part 726 (entitled "Black Lung Benefits; 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 insurance 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 announced, appellants sought declaratory and injunctive relief

in the United States District Court for the District of Columbia. See Am. Compl. p 1, reprinted in Joint Appendix

("J.A.") 1. They challenged many of the rules as impermissibly 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

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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 summary 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

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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 government, 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 "regulation" 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 language 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 Workplace 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

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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 provided that there would be "no administrative or judicial

review of a determination respecting an application for adjustment 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 unconstitutional practices and policies used by the agency in processing 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 precluded 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 challenged 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.

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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. Before 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 Department's position that the mine operator was obliged to post the

names. The Court held that the District Court lacked jurisdiction 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 meaningfully 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 preenforcement 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).

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Labor Department to prevent the Secretary from independently 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 administrative process by challenging a Department enforcement

position in a district court. Compare Compensation Department, 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, following 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

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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 Conference of Japan/Korea v. Federal Maritime Comm'n, 650

F.2d 1235, 1244-45 (D.C. Cir. 1980) (distinguishing noticeand-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 appellants' 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).

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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 challenged 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 undisputed here that the Secretary was not authorized to promulgate

retroactive rules governing BLBA benefits determinations.

Hence, the parties dispute only whether the challenged regulations 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 procedural 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

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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 retroactively." Id. This inquiry involves a "commonsense, functional judgment about 'whether the new provision attaches new

legal consequences to events completed before its enactment.' " 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 "procedural" 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

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promulgated. See National Mining, 177 F.3d at 8 (explaining that "[w]here before there was 'a range of possible

interpretations,' " of the relevant statutes, a rule may establish " 'a precise interpretation' " that changes the legal landscape) (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 Appellants 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 "subsequent claims." We reject this argument. Under both the

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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" instructs 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 relationship (a doctor's opinion is entitled to more weight if he

has treated the miner for pulmonary, as opposed to nonpulmonary, conditions), its duration, the frequency of treatment, 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 "appropriate 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 documentation, 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

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agency adjudicator may give weight to the treating physician'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. McCandless, 255 F.3d 465, 469 (7th Cir. 2001), relied upon by NMA,

the Seventh Circuit restated its disapproval of "any mechanical 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 demanded 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 documentation" 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 consideration," but rejected any requirement or presumption that

their opinions automatically be given greater weight. Id.

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(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 medical 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 impermissibly retroactive. Section 718.201(a) parrots the statutory definition 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 pneumoconiosis 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 employment." Id. s 718.201(a)(2).

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NMA challenges as retroactive the inclusion of restrictive

or obstructive pulmonary disease in the definition of pneumoconiosis. It argues that most courts require individual miners 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 miner's obstructive lung disease was caused by smoking, rather

than mining. This objection is entirely meritless. The regulation's plain text in no way indicates that medical reports will

be excluded if they conclude that a particular miner's obstructive 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 acceptable. 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 progressive disease which may first become detectable only after the

cessation of coal mine dust exposure." Appellants argue that

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this regulatory statement is impermissibly retroactive, because 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 conceded 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 never 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 pneumoconiosis 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 subsequent claim will be denied unless the deputy commissioner

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tions." 20 C.F.R. s 725.309(d) (2000). Counsel acknowledged 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 progressive. 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 pneumoconiosis 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 condition 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 contested 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 Secretary's prior interpretation. NMA, 160 F. Supp. 2d at 67-68

(citing many cases and adding a "But see" citation to Vigna).

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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 disability 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 pneumoconiosis. 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 determine whether the miner was totally disabled due to pneumoconiosis without considering his unrelated, nonpulmonary

disability. The new regulation thus changes the legal landscape 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 determination 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 creates a rebuttable presumption that when a miner who is

eligible for black lung benefits receives medical treatment for

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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 treatment 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 treatment 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 policy. 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

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of uniformity. Id. at 513-14 (citing Director, OWCP v. Greenwich 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 "benefits" 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 claimant."

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 "benefits" are awarded. When no benefits are awarded, the cost of

the examination presumably will continue to be paid by the

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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 regulation said nothing about payments funded out of general

revenues, so the court declined to exclude workers' compensation 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 Secretary 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 impermissibly retroactive as applied to claims filed after the regulations' effective date.

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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. Compare 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 determination 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 Security Act definitions found at 42 U.S.C. s 416). The District

Court agreed, holding that the revisions "bring the regulations 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' application 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. Presumably, 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

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an order of this court, the Secretary stated that the provisions would apply to all claims pending on the new regulations' 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 applicability of the provisions).

In either case, we hold that it would be unlawfully retroactive 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 regulations. 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 amendments, 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 surviving 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 dealing 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 regulation promulgated pursuant to notice-and-comment rulemaking. 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 definitions to all claims filed after the 1990 amendment date is

merely a correct application of the law in effect since that

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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 unambiguously 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 construction 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 rationality." 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).

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We give particular deference to an agency's promulgation of

evidentiary rules governing its own adjudications; the agency'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" pneumoconiosis ("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 "redefine[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

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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 detectable only after the cessation of coal mine dust exposure,"

lacks support in the administrative record and is thus arbitrary 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 Pneumoconiosis in Ex-Coalminers After Cessation of Exposure to Coalmine 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 "always" or "typically" a latent and progressive disease. Although the regulation could be so read - "pneumoconiosis is

recognized as a latent and progressive disease" - the remaining language provides that the disease "may first become

detectable only after the cessation of coal mine dust exposure." The Secretary resolved this ambiguity at oral argument. 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]

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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 "irrebuttable presumption" that a claimant has pneumoconiosis, id. at

46, finds no support in the regulation's language. The revised 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 regulation "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 evidence 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 miner'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 authorization, agencies may not informally create rules that supplant 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 inapplicable here, for neither the revised regulation's plain language

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nor the Secretary's interpretation, see Br. for Appellees at 38,

relieves claimants of the burden of proving both pneumoconiosis and the credibility of the doctor's opinion. Indeed, the

Secretary points out that this regulation does not even "address 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 suggests that the rule enables doctors to help claimants obtain

benefits fraudulently by "exaggerating" the extent of claimants' 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 testimony only where physician's opinion is credible and consistent 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 argument, NMA cites record evidence suggesting that "there is a

significant likelihood that a treating physician will use deception 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 conclusions 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

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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 "pneumoconiosis 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 hastening-cause conclusion may be made. Moreover, it expressly

requires claimants to prove that pneumoconiosis is the hastening 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 indicating 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) Hospital). Although NMA cites two medical studies suggesting

contrary conclusions, see J.A. 1167, 2468, the Secretary considered 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 possibility," 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.

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Operator Liability Rules

Section 725.408 establishes a deadline for coal mine operators 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 determined 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 argues 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 assertion 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 regulations 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 'proponent' 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.

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NMA argues that s 725.495(c) is also arbitrary and capricious because it rests on the premise that "employers and

carriers are better situated to identify and prove an alternative liable party." Br. for Appellants at 64. As the Secretary

points out, however, s 725.495(c) is not based on that presumption. 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). Although 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 presumption 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 unrelated 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 Appellants 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 production 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 presumption "shifts only the burden of production, not persuasion"); see also Ling, 176 F.3d at 233-34 (holding that an

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identical "presumption merely reallocates the burden of production, 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

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Sixth, Seventh, and Tenth Circuits). But see Vigna, 22 F.3d

at 1394-95.

Challenging the total disability rule as arbitrary and capricious, NMA claims that the regulation "is supported only by

an intent to reverse" the Seventh Circuit's decision in Peabody 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 assertion 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 interpretations 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 evidentiary 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 concluding 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, because 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

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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 establish 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 arbitrary 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 rereadings 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 arbitrarily 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 Security Act's definition of "dependent." See 30 U.S.C. s 902(a)

(incorporating the Social Security Act's definition of "dependents"). These regulations (ss 725.204, 725.213(c), 725.214,

725.219(d)) broaden the definition of "dependent" to track

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more closely recent revisions of the incorporated Social Security 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 Wildlife 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 "Congress 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 required "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 remedies, 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 representative, [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

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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 "specific 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 authority; 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 feeshifting 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 proceedings consistent with this opinion.

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