10 Timing of Judicial Review 10 Timing of Judicial Review
10.1 Ripeness 10.1 Ripeness
10.1.1 Abbott Labs v. Gardner, 387 U.S. 136 (1967) 10.1.1 Abbott Labs v. Gardner, 387 U.S. 136 (1967)
ABBOTT LABORATORIES et al. v. GARDNER, SECRETARY OF HEALTH, EDUCATION, AND WELFARE, et al.
No. 39.
Argued January 16, 1967.
Decided May 22, 1967.
*137Gerhard A. Gesell argued the cause and filed briefs for petitioners.
Nathan Lewin argued the cause for respondents. With him on the brief were Solicitor General Marshall, Assistant Attorney General Vinson, Beatrice Rosenberg, Jerome M. Feit and William W. Goodrich.
delivered the opinion of the Court.
In 1962 Congress amended the Federal Food, Drug, and Cosmetic Act (52 Stat. 1040, as amended by the Drug Amendments of 1962, 76 Stat. 780, 21 U. S. C. § 301 et seq.), to require manufacturers of prescription drugs to print the “established name” of the drug “prominently *138and in type at least half as large as that used thereon for any proprietary name or designation for such drug,” on labels and other printed material, § 502 (e)(1)(B), 21 U. S. C. § 352 (e)(1)(B). The “established name” is one designated by the Secretary of Health, Education, and Welfare pursuant to § 502(e)(2) of the Act, 21 U. S. C. § 352 (e) (2); the “proprietary name” is usually a trade name under which a particular drug is marketed. The underlying purpose of the 1962 amendment was to bring to the attention of doctors and patients the fact that many of the drugs sold under familiar trade names are actually identical to drugs sold under their “established” or less familiar trade names at significantly lower prices. The Commissioner of Food and Drugs, exercising authority delegated to him by the Secretary, 22 Fed. Reg. 1051, 25 Fed. Reg. 8625, published proposed regulations designed to implement the statute, 28 Fed. Reg. 1448. After inviting and considering comments submitted by interested parties the Commissioner promulgated the following regulation for the “efficient enforcement” of the Act, § 701 (a), 21 U. S. C. § 371 (a):
“If the label or labeling of a prescription drug bears a proprietary name or designation for the drug or any ingredient thereof, the established name, if such there be, corresponding to such proprietary name or designation, shall accompany each appearance of such proprietary name or designation.” 21 CFR §1.104 (g)(1).
A similar rule was made applicable to advertisements for prescription drugs, 21 CFR § 1.105 (b)(1).
The present action was brought by a group of 37 individual drug manufacturers and by the Pharmaceutical Manufacturers Association, of which all the petitioner companies are members, and which includes manufacturers of more than 90% of the Nation’s supply of pre*139scription drugs. They challenged the regulations on the ground that the Commissioner exceeded his authority under the statute by promulgating an order requiring labels, advertisements, and other printed matter relating to prescription drugs to designate the established name of the particular drug involved every time its trade name is used anywhere in such material.
The District Court, on cross motions for summary judgment, granted the declaratory and injunctive reliéf sought, finding that the statute did not sweep so broadly as to permit the Commissioner’s “every time” interpretation. 228 F. Supp. 855. The Court of Appeals for the Third Circuit reversed without reaching the merits of the case. 352 F. 2d 286. It held first that under the statutory scheme provided by the Federal Food, Drug, and Cosmetic Act pre-enforcement1 review of these regulations was unauthorized and therefore beyond the jurisdiction of the District Court. Second, the Court of Appeals held that no “actual case or controversy” existed and, for that reason, that no relief under the Administrative Procedure Act, 5 U. S. C. §§ 701-704 (1964 ed., Supp. II), or under the Declaratory Judgment Act, 28 U. S. C. § 2201, was in any event available. Because of the general importance of the question, and the apparent conflict with the decision of the Court of Appeals for the Second Circuit in Toilet Goods Assn. v. Gardner, 360 F. 2d 677, which we also review today, post, p. 158, we granted certiorari. 383 U. S. 924.
I.
The first question we consider is whether Congress by the Federal Food, Drug, and Cosmetic Act intended to forbid pre-enforcement review of this sort of regulation *140promulgated by the Commissioner. The question is phrased in terms of “prohibition” rather than “authorization” because a survey of our cases shows that judicial review of a final agency action by an aggrieved person will not be cut off unless there is persuasive reason to believe that such was the purpose of Congress. Board of Governors v. Agnew, 329 U. S. 441; Heikkila v. Barber, 345 U. S. 229; Brownell v. Tom We Shung, 352 U. S. 180; Harmon v. Brucker, 355 U. S. 579; Leedom v. Kyne, 358 U. S. 184; Rusk v. Cort, 369 U. S. 367. Early cases in which this type of judicial review was entertained, e. g., Shields v. Utah Idaho Central R. Co., 305 U. S. 177; Stark v. Wickard, 321 U. S. 288, have been reinforced by the enactment of the Administrative Procedure Act, which embodies the basic presumption of judicial review to one “suffering legal wrong because of agency action, or adversely affected or aggrieved by agency action within the meaning of a relevant statute,” 5 U. S. C. § 702, so long as no statute precludes such relief or the action is not one committed by law to agency discretion, 5 U. S. C. § 701 (a). The Administrative Procedure Act provides specifically not only for review of “[a]gency action made reviewable by statute” but also for review of “final agency action for which there is no other adequate remedy in a court,” 5 U. S. C. § 704. The legislative material elucidating that seminal act manifests a congressional intention that it cover a broad spectrum of administrative actions,2 and this Court has echoed that theme by noting that the Ad*141ministrative Procedure Act’s “generous review provisions” must be given a “hospitable” interpretation. Shaughnessy v. Pedreiro, 349 U. S. 48, 51; see United States v. Interstate Commerce Comm’n, 337 U. S. 426, 433-435; Brownell v. Tom We Shung, supra; Heikkila v. Barber, supra. Again in Rusk v. Cort, supra, at 379-380, the Court held that only upon a showing of “clear and convincing evidence” of a contrary legislative intent should the courts restrict access to judicial review. See also Jaffe, Judicial Control of Administrative Action 336-359 (1965).
Given this standard, we are wholly unpersuaded that the statutory scheme in the food and drug area excludes this type of action. The Government relies on no explicit statutory authority for its argument that pre-enforcement review is unavailable, but insists instead that because the statute includes a specific procedure for such review of certain enumerated kinds of regulations,3 not encompassing those of the kind involved here, other types were necessarily meant to be excluded from any pre-enforcement review. The issue, however, is not so readily resolved; we must go further and inquire whether in the context of the entire legislative scheme the existence of that circumscribed remedy evinces a congressional purpose to bar agency action not within its purview from judicial review. As a leading authority in this field has noted, “The mere fact that some acts are made reviewable should not suffice to support an implication of exclusion as to others. The right to review is too important to be excluded on such slender and indeterminate evidence of legislative intent.” Jaffe, supra, at 357.
*142In this case the Government has not demonstrated such a purpose; indeed, a study of the legislative history shows rather conclusively that the specific review provisions were designed to give an additional remedy and not to cut down more traditional channels of review. At the time the Pood, Drug, and Cosmetic Act was under consideration, in the late 1930’s, the Administrative Procedure Act had not yet been enacted,4 the Declaratory Judgment Act was in its infancy,5 and the scope of judicial review of administrative decisions under the equity power was unclear.6 It was these factors that led to the form the statute ultimately took. There is no evidence at all that members of Congress meant to preclude traditional avenues of judicial relief. Indeed, throughout the consideration of the various bills submitted to deal with this issue, it was recognized that “There is always an appropriate remedy in equity in cases where an administrative officer has exceeded his authority and there is no adequate remedy of law, . . . [and that] protection is given by the so-called Declaratory Judgments Act . . . H. R. Rep. No. 2755, 74th Cong., 2d Sess., 8. It was specifically brought to the attention of Congress that such methods had in fact been used in the food and drug area,7 and the Department of Justice, in opposing the enactment of the special-review procedures of § 701, submitted a memorandum which was read on the floor of the House *143stating: “As a matter of fact, the entire subsection is really unnecessary, because even without any express provision in the bill for court review, any citizen aggrieved by any order of the Secretary, who contends that the order is invalid, may test the legality of the order by bringing an injunction suit against the Secretary, or the head of the Bureau, under the general equity powers of the court.” 83 Cong. Rec. 7892 (1938).
The main issue in contention was whether these methods of review were satisfactory. Compare the majority and minority reports on the review provisions, H. R. Rep. No. 2139, 75th Cong., 3d Sess. (1938), both of which acknowledged that traditional judicial remedies were available, but disagreed as to the need for additional procedures. The provisions now embodied in a modified form in § 701 (f) were supported by those who feared the life-and-death power given by the Act to the executive officials, a fear voiced by many members of Congress. The supporters of the special-review section sought to include it in the Act primarily as a method of reviewing agency factual determinations. For example, it was argued that the level of tolerance for poisonous sprays on apple crops, which the Secretary of Agriculture had recently set, was a factual matter, not reviewable in equity in the absence of a special statutory review procedure.8 Some congressmen urged that challenge to this type of determination should be in the form of a de novo hearing in a district court, but the Act as it was finally passed compromised the matter by allowing an appeal on a record with a “substantial evidence” test, affording a considerably more generous judicial review than the “arbitrary and capricious” test available in the traditional injunctive suit.9
*144A second reason for the special procedure was to provide broader venue to litigants challenging such technical agency determinations. At that time, a suit against the Secretary was proper only in the District of Columbia, an advantage that the Government sought to preserve. The House bill, however, originally authorized review in any district court, but in the face of a Senate bill allowing review only in the District of Columbia, the Conference Committee reached the compromise preserved in the present statute authorizing review of such agency actions by the courts of appeals.10
Against this background we think it quite apparent that the special-review procedures provided in § 701 (f), applying to regulations embodying technical factual determinations,11 were simply intended to assure adequate judicial review of such agency decisions, and that their enactment does not manifest a congressional purpose to eliminate judicial review of other kinds of agency action.
This conclusion is strongly buttressed by the fact that the Act itself, in § 701 (f)(6), states, “The remedies provided for in this subsection shall be in addition to and not in substitution for any other remedies provided by law.” This saving clause was passed over by the Court of Appeals without discussion. In our view, however, it bears heavily on the issue, for if taken at face value it would foreclose the Government’s main argument in this case. The Government deals with the clause by arguing that it should be read as applying only to review of *145regulations under the sections specifically enumerated in § 701 (e). This is a conceivable reading, but it requires a considerable straining both of language and of common understanding. The saving clause itself contains no limitations, and it requires an artificial statutory construction to read a general grant of a right to judicial review begrudgingly, so as to cut out agency actions that a literal reading would cover.
There is no support in the legislative background for such a reading of the clause. It was included in the House bill, whose report states that the provision . . saved as a method to review a regulation placed in effect by the Secretary whatever rights exist to initiate a historical proceeding in equity to enjoin the enforcement of the regulation, and whatever rights exist to initiate a declaratory judgment proceeding.” H. R. Rep. No. 2139, 75th Cong., 3d Sess., 11. The Senate conferees accepted the provision.12 The Government argues that the clause is included as a part of § 701 (f), and therefore should be read to apply only to those sections to which the § 701 (f) special-review procedure applies. But it is difficult to think of a more appropriate place to put a general saving clause than where Congress placed it — at the conclusion of the section setting out a special procedure for use in certain specified instances. Furthermore, the Government's reading would result in an anomaly. The §§ 701 (e)-(f) procedure was included in the Act in order to deal with the problem of technical determinations for which the normal equity power was deemed insufficient. See, supra, pp. 142-144. There would seem little reason for Congress to have enacted § 701 (f), and at the same time to have included a clause aimed only at preserving for such determinations the *146other types of review whose supposed inadequacy was the very reason for the special-review provisions.
Under the Government’s view, indeed, it is difficult to ascertain when the saving clause would even come into play: when the special provisions apply, presumably they must be used and a court would not grant injunctive or declaratory judgment relief unless the appropriate administrative procedure is exhausted.13 When the special procedure does not apply, the Government deems the saving clause likewise inapplicable. The Government, to be sure, does present a rather far-fetched example of what it considers a possible application of the relief saved by § 701 (f)(6), but merely to state it reveals the weakness of the Government’s position.14 We prefer to take the saving clause at its face value, and to read it in harmony with the policy favoring judicial review expressed in the Administrative Procedure Act and this Court’s decisions.
The only other argument of the Government requiring attention on the preclusive effect of the statute is that Ewing v. Mytinger & Casselberry, Inc., 339 U. S. 594, counsels a restrictive view of judicial review in the food and drug area. In that case the Food and Drug Administrator found that there was probable cause that a drug was “adulterated” because it was misbranded in such a way as to be “fraudulent” or “misleading to *147the injury or damage of the purchaser or consumer.” § 304 (a), 21 U. S. C. § 334 (a). Multiple seizures were ordered through libel actions. The manufacturer of the drug brought an action to challenge directly the Administrator’s finding of probable cause. This Court held that the owner could raise his constitutional, statutory, and factual claims in the libel actions themselves, and that the mere finding of probable cause by the Administrator could not be challenged in a separate action. That decision was quite clearly correct, but nothing in its reasoning or holding has any bearing on this declaratory judgment action challenging a promulgated regulation.
The Court in Ewing first noted that the “administrative finding of probable cause required by § 304 (a) is merely the statutory prerequisite to the bringing of the lawsuit,” at which the issues are aired. 339 U. S., at 598. Such a situation bears no analogy to the promulgation, after formal procedures, of a rule that must be followed by an entire industry. To equate a finding of probable cause for proceeding against a particular drug manufacturer with the promulgation of a self-operative industry-wide regulation, such as we have here, would immunize nearly all agency rulemaking activities from the coverage of the Administrative Procedure Act.
Second, the determination of probable cause in Ewing has “no effect in and of itself,” 339 U. S., at 598; only some action consequent upon such a finding could give it legal life. As the Court there noted, like a determination by a grand jury that there is probable cause to proceed against an accused, it is a finding which only has vitality once a proceeding is commenced, at which time appropriate challenges can be made. The Court also noted that the unique type of relief sought by the drug manufacturer was inconsistent with the policy of the Act favoring speedy action against goods in circulation that are believed on probable cause to be adul*148terated. Also, such relief was not specifically granted by the Act, which did provide another type of relief in the form of a consolidation of multiple libel actions in a convenient venue. 339 U. S., at 602.
The drug manufacturer in Ewing was quite obviously seeking an unheard-of form of relief which, if allowed, would have permitted interference in the early stages of an administrative determination as to specific facts, and would have prevented the regular operation of the seizure procedures established by the Act. That the Court refused to permit such an action is hardly authority for cutting off the well-established jurisdiction of the federal courts to hear, in appropriate cases, suits under the Declaratory Judgment Act and the Administrative Procedure Act challenging final agency action of the kind present here.
We conclude that nothing in the Food, Drug, and Cosmetic Act itself precludes this action.
h — ( 1 — 1
A further inquiry must, however, be made. The injunc-tive and declaratory judgment remedies are discretionary, and courts traditionally have been reluctant to apply them to administrative determinations unless these arise in the context of a controversy “ripe” for judicial resolution. Without undertaking to survey the intricacies of the ripeness doctrine15 it is fair to say that its basic rationale is to prevent the courts, through avoidance of premature adjudication, from entangling themselves in abstract disagreements over administrative policies, and also to protect the agencies from judicial interference until an administrative decision has been formalized and its effects felt in a concrete way by the challenging *149parties. The problem is best seen in a twofold aspect, requiring us to evaluate both the fitness of the issues for judicial decision and the hardship to the parties of withholding court consideration.
As to the former factor, we believe the issues presented are appropriate for judicial resolution at this time. First, all parties agree that the issue tendered is a purely legal one: whether the statute was properly construed by the Commissioner to require the established name of the drug to be used every time the proprietary name is employed.16 Both sides moved for summary judgment in the District Court, and no claim is made here that further administrative proceedings are contemplated. It is suggested that the justification for this rule might vary with different circumstances, and that the expertise of the Commissioner is relevant to passing upon the validity of the regulation. This of course is true, but the suggestion overlooks the fact that both sides have approached this case as one purely of congressional intent, and that the Government made no effort to justify the regulation in factual terms.
Second, the- regulations in issue we find to be “final agency action” within the meaning of § 10 of the Administrative Procedure Act, 5 U. S. C. § 704, as construed in judicial decisions. An “agency action” includes any “rule,” defined by the Act as “an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy,” §§ 2 (c), 2 (g), 5 U. S. C. §§ 551 (4), 551 (13). The cases dealing with judicial review of administrative actions have interpreted the “finality” element in a pragmatic way. Thus in Columbia Broadcasting System *150v. United States, 316 U. S. 407, a suit under the Urgent Deficiencies Act, 38 Stat. 219, this Court held reviewable a regulation of the Federal Communications Commission setting forth certain proscribed contractual arrangements between chain broadcasters and local stations. The FCC did not have direct authority to regulate these contracts, and its rule asserted only that it would not license stations which maintained such contracts with the networks. Although no license had in fact been denied or revoked, and the FCC regulation could properly be characterized as a statement only of its intentions, the Court held that “Such regulations have the force of law before their sanctions are invoked as well as after. When, as here, they are promulgated by order of the Commission and the expected conformity to them causes injury cognizable by a court of equity, they are appropriately the subject of attack . . . 316 U. S., at 418-419.
Two more recent cases have taken a similarly flexible view of finality. In Frozen Food Express v. United States, 351 U. S. 40, at issue was an Interstate Commerce Commission order specifying commodities that were deemed to fall within the statutory class of “agricultural commodities.” Vehicles carrying such commodities were exempt from ICC supervision. An action was brought by a carrier that claimed to be transporting exempt commodities, but which the ICC order had not included in its terms. Although the dissenting opinion noted that this ICC order had no authority except to give notice of how the Commission interpreted the Act and would have effect only if and when a particular action was brought against a particular carrier, and argued that “judicial intervention [should] be withheld until administrative action has reached its complete development,” 351 U. S., at 45, the Court held the order reviewable.
*151Again, in United States v. Storer Broadcasting Co., 351 U. S. 192, the Court held to be a final agency action within the meaning of the Administrative Procedure Act an FCC regulation announcing a Commission policy that it would not issue a television license to an applicant already owning five such licenses, even though no specific application was before the Commission. The Court stated: “The process of rulemaking was complete. It was final agency action ... by which Storer claimed to be ‘aggrieved/ ” 351 U. S., at 198.
We find decision in the present case following a fortiori from these precedents. The regulation challenged here, promulgated in a formal manner after announcement in the Federal Register and consideration of comments by interested parties 17 is quite clearly definitive. There is no hint that this regulation is informal, see Helco Products Co. v. McNutt, 78 U. S. App. D. C. 71, 137 F. 2d 681, or only the ruling of a subordinate official, see Swift & Co. v. Wickham, 230 F. Supp. 398, 409, aff’d, 364 F. 2d 241, or tentative. It was made effective upon publication, and the Assistant General Counsel for Food and Drugs stated in the District Court that compliance was expected.
The Government argues, however, that the present case can be distinguished from cases like Frozen Food Express on the ground that in those instances the agency involved could implement its policy directly, while here the Attorney General must authorize criminal and seizure actions for violations of the statute. In the context of this case, we do not find this argument persuasive. These regulations are not meant to advise the Attorney General, but purport to be directly authorized by the statute. Thus, if within the Commissioner’s authority, *152they have the status of law and violations of them carry heavy criminal and civil sanctions. Also, there is no representation that the Attorney General and the Commissioner disagree in this area; the Justice Department is defending this very suit. It would be adherence to a mere technicality to give any credence to this contention. Moreover, the agency does have direct authority to enforce this regulation in the context of passing upon applications for clearance of new drugs, § 505, 21 U. S. C. § 355, or certification of certain antibiotics, § 507, 21 U. S. C. § 357.
This is also a case in which the impact of the regulations upon the petitioners is sufficiently direct and immediate as to render the issue appropriate for judicial review at this stage. These regulations purport to give an authoritative interpretation of a statutory provision that has a direct effect on the day-to-day business of all prescription drug companies; its promulgation puts petitioners in a dilemma that it was the very purpose of the Declaratory Judgment Act to ameliorate.18 As the District Court found on the basis of uncontested allegations, “Either they must comply with the every time requirement and incur the costs of changing over their promotional material and labeling or they must follow their present course and risk prosecution.” 228 F. Supp. 855, 861. The regulations are clear-cut, and were made effective immediately upon publication; as noted earlier the agency’s counsel represented to the District Court that immediate compliance with their terms was expected. If petitioners wish to comply they must change all their labels, advertisements, and promotional materials; they must destroy stocks of printed matter; and they must invest heavily in new printing type and new supplies. *153The alternative to compliance — continued use of material which they believe in good faith meets the statutory requirements, but which clearly does not meet the regulation of the Commissioner — may be even more costly. That course would risk serious criminal and civil penalties for the unlawful distribution of “mis-branded” drugs.19
It is relevant at this juncture to recognize that petitioners deal in a sensitive industry, in which public confidence in their drug products is especially important. To require them to challenge these regulations only as a defense to an action brought by the Government might harm them severely and unnecessarily. Where the legal issue presented is fit for judicial resolution, and where a regulation requires an immediate and significant change in the plaintiffs’ conduct of their affairs with serious penalties attached to noncompliance, access to the courts under the Administrative Procedure Act and the Declaratory Judgment Act must be permitted, absent a statutory bar or some other unusual circumstance, neither of which appears here.
The Government does not dispute the very real dilemma in which petitioners are placed by the regulation, but contends that “mere financial expense” is not a justification for pre-enforcement judicial review. It is of course true that cases in this Court dealing with the standing of particular parties to bring an action have held that a possible financial loss is not by itself a sufficient interest to sustain a judicial challenge to governmental action. Frothingham v. Mellon, 262 U. S. 447; Perkins v. Lukens *154Steel Co., 310 U. S. 113. But there is no question in the present case that petitioners have sufficient standing as plaintiffs: the regulation is directed at them in particular; it requires them to make significant changes in their everyday business practices; if they fail to observe the Commissioner’s rule they are quite clearly exposed to the imposition of strong sanctions. Compare Columbia Broadcasting System v. United States, 316 U. S. 407; 3 Davis, Administrative Law Treatise, c. 21 (1958). This case is, therefore, remote from the Mellon and Perkins cases.
The Government further contends that the threat of criminal sanctions for noncomplianee with a judicially untested regulation is unrealistic; the Solicitor General has represented that if court enforcement becomes necessary, “the Department of Justice will proceed only civilly for an injunction ... or by condemnation.” We cannot accept this argument as a sufficient answer to petitioners’ petition. This action at its inception was properly brought and this subsequent representation of the Department of Justice should not suffice to defeat it.
Finally, the Government urges that to permit resort to the courts in this type of case may delay or impede effective enforcement of the Act. We fully recognize the important public interest served by assuring prompt and unimpeded administration of the Pure Food, Drug, and Cosmetic Act, but we do not find the Government’s argument convincing. First, in this particular case, a pre-enforcement challenge by nearly all prescription drug manufacturers is calculated to speed enforcement. If the Government prevails, a large part of the industry is bound by the decree; if the Government loses, it can more quickly revise its regulation.
The Government contends, however, that if the Court allows this consolidated suit, then nothing will prevent a multiplicity of suits in various jurisdictions challenging other regulations. The short answer to this contention *155is that the courts are well equipped to deal with such eventualities. The venue transfer provision, 28 U. S. C. § 1404 (a), may be invoked by the Government to consolidate separate actions. Or, actions in all but one jurisdiction might be stayed pending the conclusion of one proceeding. See American Life Ins. Co. v. Stewart, 300 U. S. 203, 215-216. A court may even in its discretion dismiss a declaratory judgment or injunctive suit if the same issue is pending in litigation elsewhere. Maryland Cas. Co. v. Consumers Finance Service, 101 F. 2d 514; Carbide & Carbon C. Corp. v. United States I. Chemicals, 140 F. 2d 47; Note, Availability of a Declaratory Judgment When Another Suit Is Pending, 51 Yale L. J. 511 (1942). In at least one suit for a declaratory judgment, relief was denied with the suggestion that the plaintiff intervene in a pending action elsewhere. Automotive Equip., Inc. v. Trico Prods. Corp., 11F. Supp. 292; See Allstate Ins. Co. v. Thompson, 121 F. Supp. 696.
Further, the declaratory judgment and injunctive remedies are equitable in nature, and other equitable defenses may be interposed. If a multiplicity of suits are undertaken in order to harass the Government or to delay enforcement, relief can be denied on this ground alone. Truly v. Wanzer, 5 How. 141, 142; cf. Brillhart v. Excess Ins. Co., 316 U. S. 491, 495. The defense of laches could be asserted if the Government is prejudiced by a delay, Southern Pac. Co. v. Bogert, 250 U. S. 483, 488-490; 2 Pomeroy’s Equity Jurisprudence §§419c-d (5th ed. Symons, 1941). And courts may even refuse declaratory relief for the nonjoinder of interested parties who are not, technically speaking, indispensable. Cf. Samuel Goldwyn, Inc. v. United Artists Corp., 113 F. 2d 703; 6A Moore, Federal Practice ¶ 57.25 (2d ed. 1966).
In addition to all these safeguards against what the Government fears, it is important to note that the institution of this type of action does not by itself stay the effectiveness of the challenged regulation. There is *156nothing in the record to indicate that petitioners have sought to stay enforcement of the “every time” regulation pending judicial review. See 5 U. S. C. § 705. If the agency believes that a suit of this type will significantly impede enforcement or will harm the public interest, it need not postpone enforcement of the regulation and may oppose any motion for a judicial stay on the part of those challenging the regulation. Ibid. It is scarcely to be doubted that a court would refuse to postpone the effective date of an agency action if the Government could show, as it made no effort to do here, that delay would be detrimental to the public health or safety. See Associated Securities Corp. v. SEC, 283 F. 2d 773, 775, where a stay was denied because “the petitioners . .. [had] not sustained the burden of establishing that the requested stays will not be harmful to the public interest . . see Eastern Air Lines v. CAB, 261 F. 2d 830; cf. Scripps-Howard Radio v. FCC, 316 U. S. 4, 10-11; 5 U. S. C. § 705.
Lastly, although the Government presses us to reach the merits of the challenge to the regulation in the event we find the District Court properly entertained this action, we believe the better practice is to remand the case to the Court of Appeals for the Third Circuit to review the District Court’s decision that the regulation was beyond the power of the Commissioner.20
Reversed and remanded.
Mr. Justice Brennan took no part in the consideration or decision of this case.
*157[For dissenting opinions of Me. Justice Foetas and Me. Justice Claek, see post, pp. 174 and 201, respectively.]
That is, a suit brought by one before any attempted enforcement of the statute or regulation against him.
See H. R. Rep. No. 1980, 79th Cong., 2d Sess., 41 (1946): “To preclude judicial review under this bill a statute, if not specific in withholding such review, must upon its face give clear and convincing evidence of an intent to withhold it. The mere failure to provide specially by statute for judicial review is certainly no evidence of intent to withhold review.” See also S. Rep. No. 752, 79th Cong., 1st Sess., 26 (1945).
Embodied in §§701 (e), (f), 21 U. S. C. §§371 (e), (f), and discussed hereafter. Section 701 (e) provides a procedure for the issuance of regulations under certain specifically enumerated statutory sections. Section 701 (f) establishes a procedure for direct review by a court of appeals of a regulation promulgated under § 701 (e).
The Administrative Procedure Act was enacted in 1946, 60 Stat. 237.
The Declaratory Judgment Act was enacted in 1934, 48 Stat. 955.
See, e. g., the discussion of judicial review under the equity power in the House of Representatives during the debate on these provisions. 83 Cong. Rec. 7891-7896 (1938).
See, e. g., 83 Cong. Rec. 7783 (remarks of Representative Leavy) (1938); Statement of Professor David F. Cavers before a Subcommittee of the Senate Committee on Commerce on S. 1944, 73d Cong., 2d Sess. (1933), reprinted in Dunn, Federal Food, Drug, and Cosmetic Act, A Statement of Its Legislative Record 1110 (1938).
See, e. g., 83 Cong. Rec. 7772-7773, 7781-7784, 7893-7899 (1938).
See, e. g., the discussion of the conference report, 83 Cong. Rec. 9096-9098 (1938).
See, e. g., 83 Cong. Rec. 7772, 7892, 9092-9093 (1938).
See Toilet Goods Assn. v. Gardner, 360 F. 2d 677, 683, where the court noted that “The agency determinations specifically reviewable under § 701 (e) relate to such technical subjects as chemical properties of particular products and the formulation and application of safety standards for protecting public health; Congress naturally did not wish courts to consider such matters without the benefit of the agency’s views after an evidentiary hearing before it.”
H. R. Conf. Rep. No. 2716, 75th Cong., 3d Sess., 25 (1938); 83 Cong. Rec. 8731-8738 (1938) (Senate agreement to the conference report).
See Notes of the Advisory Committee on Federal Rule of Civil Procedure 57, reprinted in 28 U. S. C. App., at 6136: “A declaration may not be rendered if a special statutory proceeding has been provided for the adjudication of some special type of case . . . .” See also 6A Moore, Federal Practice §57.08[3] (2d ed. 1966).
The Government apparently views the clause as applying only when regulations falling within the special-review procedure are promulgated without affording the required public notice and opportunity to file objections and to request a public hearing. In such a case alone, the Government asserts, “an equity proceeding or a declaratory judgment action . . . might be entertained on the ground that the statutory procedures had not been followed.” Brief, p. 28.
See 3 Davis, Administrative Law Treatise, c. 21 (1958); Jaffe, Judicial Control of Administrative Action, c. 10 (1965).
While the “every time” issue has been framed by the parties in terms of statutory compulsion, we think that its essentially legal character would not be different had it been framed in terms of statutory authorization for the requirement.
Compare similar procedures followed in Frozen Food Express, supra, at 41-42, and Storer, supra, at 193-194. The procedure conformed with that prescribed in § 4 of the Administrative Procedure Act, 5 U. S. C. § 1003.
See S. Rep. No. 1005, 73d Cong., 2d Sess., 2-3 (1934); Borchard, Challenging “Penal” Statutes by Declaratory Action, 52 Yale L. J. 445, 454 (1943).
Section 502 (e)(1)(B) declares a drug not complying with this labeling requirement to be “misbranded.” Section 301, 21 U. S. C. § 331, designates as “prohibited acts” the misbranding of drugs in interstate commerce. Such prohibited acts are subject to injunction, § 302, 21 U. S. C. § 332, criminal penalties, § 303, 21 U. S. C. § 333, and seizure, § 304 (a), 21 U. S. C. § 334 (a).
A totally separate issue raised in the petition for certiorari and argued by the parties in their briefs concerns the dismissal of the complaint as to certain of the plaintiffs on the ground that venue was improper as to them. All the petitioners asserted that venue was proper in Delaware not only because some of them are incorporated there but also under 28 U. S. C. § 1391 (e)(4), allowing an *157action against a government official in any judicial district in which “the plaintiff resides . . . .” It is contended that § 1391 (e) (4) must be read to incorporate the definition of “residence” set out in 28 U. S. C. § 1391 (c): “A corporation may be sued in any judicial district in which it is incorporated or licensed to do business or is doing business, and such judicial district shall be regarded as the residence of such corporation for venue purposes.” The issue of construction is whether § 1391 (c) should be read as defining corporate venue only when the corporation is a defendant, or whether it should either (1) be adopted for corporate residence in all cases when a corporation is a plaintiff, or (2) at least as the definition of “resides” as used in § 1391 (e) (4).
This question is a difficult one, with far-reaching effects, and we think it is appropriate to dismiss our writ of certiorari as to this question for the following two reasons. First, the Court of Appeals in affirming the District Court on this issue did not explicitly endorse the lower court’s ruling but held only: “We find no prejudicial error in the dismissal of the complaint as to these plaintiffs . . . 352 F. 2d 524, 525. Review of an issue of this importance is best left to a case where it has been fully dealt with by a court of appeals. Second, one of the plaintiffs whose complaint was not dismissed is the Pharmaceutical Manufacturers Association, of which all the corporate petitioners are members, and we think it should be considered that they are adequately protected in this suit by its participation, as well as by the participation of the remaining drug companies whose interests are identical to those of the petitioners whose complaints were dismissed. Cf. Mishkin v. New York, 383 U. S. 502, 512-514. Moreover, in the further course of this litigation it will be open to the dismissed plaintiffs to seek amicus curiae status.
10.1.2 Toilet Goods Assn., Inc. v. Gardner, 387 U.S. 158 (1967), 10.1.2 Toilet Goods Assn., Inc. v. Gardner, 387 U.S. 158 (1967),
TOILET GOODS ASSOCIATION, INC., et al. v. GARDNER, SECRETARY OF HEALTH, EDUCATION, AND WELFARE, et al.
No. 336.
Argued January 16, 1967.
Decided May 22, 1967.
*159Edward J. Boss argued the cause and filed a brief for petitioners.
Nathan Lewin argued the cause for respondents. With him on the briefs were Solicitor General Marshall, Assistant Attorney General Vinson, Beatrice Rosenberg, Jerome M. Feit and William W. Goodrich.
delivered the opinion of the Court.
Petitioners in this case are the Toilet Goods Association, an organization of cosmetics manufacturers accounting for some 90% of annual American sales in this field, and 39 individual cosmetics manufacturers and distributors. They brought this action in the United States District Court for the Southern District of New York seeking declaratory and injunctive relief against the Secretary of Health, Education, and Welfare and the Commissioner of Food and Drugs, on the ground that certain regulations promulgated by the Commissioner exceeded his statutory authority under the Color Additive Amendments to the Federal Food, Drug, and Cosmetic Act, 74 Stat. 397, 21 U. S. C. §§ 321-376. The District Court held that the Act did not prohibit this type of pre-enforcement suit, that a case and controversy existed, that *160the issues presented were justiciable, and that no reasons had been presented by the Government to warrant declining jurisdiction on discretionary grounds. 235 F. Supp. 648. Recognizing that the subsequent decision of the Court of Appeals for the Third Circuit in Abbott Laboratories v. Celebrezze, 352 F. 2d 286, appeared to conflict with its holding, the District Court reaffirmed its earlier rulings but certified the question of jurisdiction to the Court of Appeals for the Second Circuit under 28 U. S. C. § 1292 (b). The Court of Appeals affirmed the judgment of the District Court that jurisdiction to hear the suit existed as to three of the challenged regulations, but sustained the Government’s contention that judicial review was improper as to a fourth. 360 F. 2d 677.
Each side below sought review here from the portions of the Court of Appeals’ decision adverse to it, the Government as petitioner in Gardner v. Toilet Goods Assn., No. 438, and the Toilet Goods Association and other plaintiffs in the present case. We granted certiorari in both instances, 385 U. S. 813, as we did in Abbott Laboratories v. Gardner, No. 39, 383 U. S. 924, because of the apparent conflict between the Second and Third Circuits. The two Toilet Goods cases were set and argued together with Abbott Laboratories.
In our decisions reversing the judgment in Abbott Laboratories, ante, p. 136, and affirming the judgment in Gardner v. Toilet Goods Assn., post, p. 167, both decided today, we hold that nothing in the Food, Drug, and Cosmetic Act, 52 Stat. 1040, as amended, bars a pre-enforcement suit under the Administrative Procedure Act, 5 U. S. C. §§ 701-704 (1964 ed., Supp. II), and the Declaratory Judgment Act, 28 U. S. C. § 2201. We nevertheless agree with the Court of Appeals that judicial review of this particular regulation in this particular context is inappropriate at this stage because, applying *161the standards set forth in Abbott Laboratories v. Gardner, the controversy is not presently ripe for adjudication.
The regulation in issue here was promulgated under the Color Additive Amendments of 1960, 74 Stat. 397, 21 U. S. C. §§ 321-376, a statute that revised and somewhat broadened the authority of the Commissioner to control the ingredients added to foods, drugs, and cosmetics that impart color to them. The Commissioner of Food and Drugs, exercising power delegated by the Secretary, 22 Fed. Reg. 1051, 25 Fed. Reg. 8625, under statutory authority “to promulgate regulations for the efficient enforcement” of the Act, § 701 (a), 21 U. S. C. § 371 (a), issued the following regulation after due public notice, 26 Fed. Reg. 679, and consideration of comments submitted by interested parties:
“(a) When it appears to the Commissioner that a person has:
“(4) Refused to permit duly authorized employees of the Food and Drug Administration free access to all manufacturing facilities, processes, and formulae involved in the manufacture of color additives and intermediates from which such color additives are derived;
“he may immediately suspend certification service to such person and may continue such suspension until adequate corrective action has been taken.” 28 Fed. Reg. 6445-6446; 21 CFR § 8.28.1
*162The petitioners maintain that this regulation is an impermissible exercise of authority, that the FDA has long sought congressional authorization for free access to facilities, processes, and formulae (see, e. g., the proposed “Drug and Factory Inspection Amendments of 1962,” H. R. 11581, 87th Cong., 2d Sess.; Hearings before the House Committee on Interstate and Foreign Commerce on H. R. 11581 and H. R. 11582, 87th Cong., 2d Sess., 67-74; H. R. 6788, 88th Cong., 1st Sess.), but that Congress has always denied the agency this power except for prescription drugs. § 704, 21 U. S. C. § 374. Framed in this way, we agree with petitioners that a “legal” issue is raised, but nevertheless we are not persuaded that the present suit is properly maintainable.
In determining whether a challenge to an administrative regulation is ripe for review a twofold inquiry must be made: first to determine whether the issues tendered are appropriate for judicial resolution, and second to assess the hardship to the parties if judicial relief is denied at that stage.
As to the first of these factors, we agree with the Court of Appeals that the legal issue as presently framed is not appropriate for judicial resolution. This is not because the regulation is not the agency’s considered and formalized determination, for we are in agreement with petitioners that under this Court’s decisions in Frozen Food Express v. United States, 351 U. S. 40, and United States v. Storer Broadcasting Co., 351 U. S. 192, there can be no question that this regulation — promulgated in a formal manner after notice and evaluation of submitted comments — is a “final agency action” under § 10 of the Administrative Procedure Act, 5 U. S. C. § 704. *163See Abbott Laboratories v. Gardner, ante, p. 136. Also, we recognize the force of petitioners’ contention that the issue as they have framed it presents a purely legal question : whether the regulation is totally beyond the agency’s power under the statute, the type of legal issue that courts have occasionally dealt-with without requiring a specific attempt at enforcement, Columbia Broadcasting System v. United States, 316 U. S. 407; cf. Pierce v. Society of Sisters, 268 U. S. 510, or exhaustion of administrative remedies, Allen v. Grand Central Aircraft Co., 347 U. S. 535; Skinner & Eddy Corp. v. United States, 249 U. S. 557.
These points which support the appropriateness of judicial resolution are, however, outweighed by other considerations. The regulation serves notice only that the Commissioner may under certain circumstances order inspection of certain facilities and data, and that further certification of additives may be refused to those who decline to permit a duly authorized inspection until they have complied in that regard. At this juncture we have no idea whether or when such an inspection will be ordered and what reasons the Commissioner will give to justify his order. The statutory authority asserted for the regulation is the power to promulgate regulations “for the efficient enforcement” of the Act, § 701 (a). Whether the regulation is justified thus depends not only, as petitioners appear to suggest, on whether Congress refused to include a specific section of the Act authorizing such inspections, although this factor is to be sure a highly relevant one, but also on whether the statutory scheme as a whole justified promulgation of the regulation. See Wong Yang Sung v. McGrath, 339 U. S. 33, 47. This will depend not merely on an inquiry into statutory purpose, but concurrently on an understanding of what types of enforcement problems are encountered by the FDA, the need for various sorts of supervision in order to effec*164tuate the goals of the Act, and the safeguards devised to protect legitimate trade secrets (see 21 CFR § 130.14 (c)). We believe that judicial appraisal of these factors is likely to stand on a much surer footing in the context of a specific application of this regulation than could be the case in the framework of the generalized challenge made here.
We are also led to this result by considerations of the effect on the petitioners of the regulation, for the test of ripeness, as we have noted, depends not only on how adequately a court can deal with the legal issue presented, but also on the degree and nature of the regulation's present effect on those seeking relief. The regulation challenged here is not, analogous to those that were involved in Columbia Broadcasting System, supra, and Storer, supra, and those other color additive regulations with which we deal in Gardner v. Toilet Goods Assn., post, p. 167, where the impact of the administrative action could be said to be felt immediately by those subject to it in conducting their day-to-day affairs. See also Federal Communications Comm’n v. American Broadcasting Co., 347 U. S. 284.
This is not a situation in which primary conduct is affected — when contracts must be negotiated, ingredients tested or substituted, or special records compiled. This regulation merely states that the Commissioner may authorize inspectors to examine certain processes or formulae; no advance action is required of cosmetics manufacturers, who since the enactment of the 1938 Act have been under a statutory duty to permit reasonable inspection of a “factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials; containers, and labeling therein.” § 704 (a). Moreover, no irremediable adverse consequences flow from requiring a later challenge to this regulation by a manufacturer who refuses to allow this type *165of inspection. Unlike the other regulations challenged in this action, in which seizure of goods, heavy fines, adverse publicity for distributing “adulterated” goods, and possible criminal liability might penalize failure to comply, see Gardner v. Toilet Goods Assn., post, p. 167, a refusal to admit an inspector here would at most lead only to a suspension of certification services to the particular party, a determination that can then be promptly challenged through an administrative procedure,2 which in turn is reviewable by a court.3 Such review will provide an adequate forum for testing the regulation in a concrete situation.
It is true that the administrative hearing will deal with the “factual basis” of the suspension, from which petitioners infer that the Commissioner will not entertain and consider a challenge to his statutory authority to pro*166mulgate the regulation.4 Whether or not this assumption is correct, given the fact that only minimal, if any, adverse consequences will face petitioners if they challenge the regulation in this manner, we think it wiser to require them to exhaust this administrative process through which the factual basis of the inspection order will certainly be aired and where more light may be thrown on the Commissioner’s statutory and practical justifications for the regulation. Compare Federal Security Adm’r v. Quaker Oats Co., 318 U. S. 218.5 Judicial review will then be available, and a court at that juncture will be in a better position to deal with the question of statutory authority. Administrative Procedure Act § 10 (e) (B)(3), 5 U. S. C. § 706 (2)(C).
For these reasons the judgment of the Court of Appettls is
Affirmed.
Mr. Justice Douglas dissents for the reasons stated by Judge Tyler of the District Court, 235 F. Supp. 648, 651-652.
Mr. Justice Brennan took no part in the consideration or decision of this case.
[For concurring opinion of Mr. Justice Fortas, see post, p. 174.]
10.1.3 NYS v. HHS (Ripeness discussion) 10.1.3 NYS v. HHS (Ripeness discussion)
NY State v. HHS, 414 F.Supp.3d 475 (2019)
[Ripeness Discussion}
1. Ripeness
HHS argues that the Spending Clause claim is unripe, and that the Court therefore lacks subject-matter jurisdiction to resolve it, because no enforcement action has been taken against the State Plaintiffs under the Rule. The State Plaintiffs counter that because the Rule forces them either to make significant and costly changes by November 22, 2019, or risk losing billions of dollars in federal funding, and because they have already begun to make such changes, their claim is ripe.
a. Applicable Legal Standards
A claim is “properly dismissed for lack of subject matter jurisdiction under Rule 12(b)(1) when the district court lacks the statutory or constitutional power to adjudicate it.” Makarova v. United States, 201 F.3d 110, 113 (2d Cir. 2000). A court lacks constitutional authority to adjudicate a claim that is unripe because “[r]ipeness is a jurisdictional inquiry.” Murphy v. New Milford Zoning Comm’n, 402 F.3d 342, 347 (2d Cir. 2005). “The burden of proving jurisdiction is on the party asserting it.” Daly v. Citigroup Inc., 939 F.3d 415, 425 (2d Cir. 2019). Plaintiffs may rely “solely on the pleadings and supporting affidavits,” and, although a court “will not draw ‘argumentative inferences’ in the plaintiff’s favor,” it is to “construe jurisdictional allegations liberally and take as true uncontroverted factual allegations.” Robinson, 21 F.3d at 507.
“The ripeness doctrine is drawn both from Article III limitations on judicial power and from prudential reasons for refusing to exercise jurisdiction.” N.Y. Civil Liberties Union v. Grandeau, 528 F.3d 122, 130 (2d Cir. 2008). In its prudential form, the doctrine serves “to prevent the courts, through avoidance of premature adjudication, from entangling themselves in abstract disagreements over administrative policies.” Abbott Labs. v. Gardner, 387 U.S. 136, 148 (1967). “At its heart is whether we would benefit from deferring initial review until the claims we are called on to consider have arisen in a more concrete and final form.” Murphy, 402 F.3d at 347.
“[D]etermining whether a dispute is ripe for review requires a two-pronged analysis of (1) whether the issues presented to the district court are fit for review, and (2) what hardship the parties will suffer in the absence of review.” Connecticut v. Duncan, 612 F.3d 107, 113 (2d Cir. 2010). The “fitness” inquiry addresses “whether the issues sought to be adjudicated are contingent on future events or may never occur.” Grandeau, 528 F.3d at 132. As to that inquiry, the Second Circuit has “dr[awn] a distinction between pre-enforcement judicial review of specific regulations promulgated by [an] agency and judicial review of a nonfinal proposed policy,” finding the latter category less likely to present a ripe controversy. Id. The “hardship” inquiry addresses “whether the challenged action creates a direct and immediate dilemma for the parties.” Id. at 134. “The mere possibility of future injury, unless it is the cause of some present detriment, does not constitute hardship.” Simmonds, 326 F.3d at 360.
b. Discussion
Measured against these standards, the State Plaintiffs’ Spending Clause claim here is clearly ripe.
First, where a dispute over agency action “presents legal questions and there is a concrete dispute between the parties, the issues are fit for judicial decision,” even where the “factual record is not yet fully developed.” Sharkey v. Quarantillo, 541 F.3d 75, 89 (2d Cir. 2008). And, when an agency issues “a substantive rule which as a practical matter requires the plaintiff to adjust his conduct immediately ... [s]uch agency action is ‘ripe’ for review at once.” Lujan v. Nat’l Wildlife Fed’n, 497 U.S. 871, 891 (1990).
Such is the case here. The Rule assigns significant new substantive meaning to the Conscience Provisions. On taking effect, it would require major and immediate changes in the policies and actions of the State Plaintiffs and their subrecipients, including with respect to hiring, staffing, transfer, and other employment decisions. And the Rule announces HHS’s intention to assure that States and others comply.
By its terms, the Rule also forces the State Plaintiffs either to adapt their operations by its effective date of November 22, 2019, or risk termination of their federal health care funding. These plaintiffs have chronicled the changes the Rule is forcing them to make. Thus, as a substantive and final regulation which raises pure questions of law and requires plaintiffs immediately to conform their conduct, the Rule is fit for immediate review. See Lujan, 497 U.S. at 891.
Second, without judicial review, the State Plaintiffs will suffer hardship. A rule that “requires an immediate and significant change in [a party’s] conduct of its affairs with serious penalties attached to noncompliance” presents a prototypical instance of hardship. Abbott Labs., 387 U.S. at 153. Where “plaintiffs must either incur great expense to comply with [a regulation’s] requirements” or risk “potentially even greater” consequences for non-compliance, they will suffer hardship if the court foregoes review. Thomas v. City of New York, 143 F.3d 31, 36 (2d Cir. 1998).
The State Plaintiffs face this predicament. By November 22, they must take major actions—with respect to policy, administration, and personnel—to bring their offices into compliance. Efforts to this end have already begun.
HHS’s claim that the State Plaintiffs must await an enforcement action against them to challenge the Rule blinks these realities.Plaintiffs “deal in a sensitive industry, in which public confidence in their [services] is especially important,” and “[t]o require them to challenge these regulations only as a defense to an action brought by the Government might harm them severely and unnecessarily.” Abbott Labs., 387 U.S. at 153. This is especially so here, where noncompliance could cost a State or locality many millions, or even billions, of dollars in federal health care funding.
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|
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The Court therefore holds that the Spending Clause claim is ripe for review.
10.2 Finality 10.2 Finality
10.2.1 National Ass’n of Homebuilders v. U.S. Army Corps of Eng’rs, 297 F. Supp. 2d 74 (D.D.C. 2003) 10.2.1 National Ass’n of Homebuilders v. U.S. Army Corps of Eng’rs, 297 F. Supp. 2d 74 (D.D.C. 2003)
NATIONAL ASSOCIATION OF HOME BUILDERS et al., Plaintiffs, v. UNITED STATES ARMY CORPS OF ENGINEERS et al., Defendants.
No. CIV.00-379(RJL).
United States District Court, District of Columbia.
Nov. 24, 2003.
*76Rafe Petersen, Lawrence R. Liebesman, Rafe Petersen, Holland & Knight, L.L.P., Washington, DC, Virginia Swisshelm Al-brecht, Hunton & Williams, Washington, DC, for Plaintiffs.
Christopher Peak, U.S. Department of Justice, Washington, DC, Eileen T. Mc-Donough, Martin F. McDermott, Silvia Se-pulveda-Hambor, Department of Justice, Environment & Natural Resources Division, Washington, DC, for Defendants.
Memorandum Opinion and Order
Before the Court are the parties’ cross-motions for summary judgment. In these three consolidated cases, the plaintiffs1 challenge nationwide permits (“NWPs”) issued under Section 404(e) of the Clean Water Act (“CWA”) by the defendant U.S. Army Corps of Engineers (“Corps”) in March 2000 and January 2002. After considering the parties motions and the opposition thereto, the Court dismisses the plaintiffs’ claims for lack of jurisdiction because the agency action setting NWPs is not a final agency action subject to review.
I. Background
Congress enacted the Clean Water Act (“CWA”) to “restore and maintain the chemical, physical, and biological” of the nation’s waters. 33 U.S.C. § 1251(a). To that end, the CWA prohibits a party from discharging pollutants, such as dredged or fill material, into navigable waters of the United States. Id. § 1311(a). Under the CWA, however, the U.S. Army Corps of Engineers (“Corps”) is authorized to allow such discharges through the issuance of permits, both general and individual. Id. § 1344. The purpose of general permits, including nationwide permits (“NWPs”), issued under CWA Section 404(e) is to allow projects that cause minimal environmental impact to go forward with little delay or paperwork. 33 C.F.R. § 330.1(b) (explaining that general permits are “designed to authorize with little, if any, delay or paperwork certain activities having minimal impacts”). If a proposed activity meets the conditions for general permits, it need not subject itself to the individual permit process through which the Corps makes de*77terminations on a case-by-case basis. 33 U.S.C. § 1344. Specifically, Section 404(e) states that
the Secretary may, after notice and opportunity for public hearing, issue general permits on a State, regional, or nationwide basis for any category of activities involving discharges of dredged or fill material if the Secretary determines that the activities in such category are similar in nature, will cause only minimal adverse environmental effects when performed separately, and will have only minimal cumulative adverse effect on the environment.
Id. § 1344(e)(1). Thus, the Corps has the discretion to issue such general permits if the polluting activities are similar in nature and will only cause minimal environmental effects. Id. If á party discharges pollutants into navigable water without meeting the conditions of a general permit or otherwise acquiring an individual permit, then the party can be subject to enforcement actions, such.as a civil administrative action by the Corps or a civil and criminal proceeding by the Department of Justice. Id. § 1319(g); 33 C.F.R. §§ 326.5, 326.6.
For five-year intervals since 1977 the Corps has been issuing NWPs, including the most widely used permit, NWP 26. 61 Fed.Reg. 65,893.2 Before the 2000 changes to the NWPs at issue in this litigation, NWP 26 authorized discharges affecting up to ten acres of waters without a party having to acquire an individual permit, and required that a party notify a Corps’ district engineer of any discharges causing loss or substantial adverse modification of one to ten acres of wetlands (this second requirement is known as a “precon-struction notification”). On June 17, 1996, the Corps proposed reissuing many of the NWPs, including NWP 26, which was to expire on January 21, 1997. On December 13, 1996, the Corps reissued NWP 26 for a period of two years, with somewhat different conditions. 61 Fed.Reg. 65,874, 65,877, 65,891, 65,895. In July 1998, the Corps published its proposed replacement permits, and extended the term of NWP 26 again. 63 Fed.Reg. 36,040. Following a public comment period in which it received 10,000 comments on the proposal, the Corps issued the final NWP 29 in August 1999, 64 Fed.Reg. 41,175, and set forth a second proposal regarding the other new permits in July 1999. 64 Fed.Reg. 39,252. On March 9, 2000, after considering even more comments, the Corps issued the permits that replaced NWP 26. 65 Fed.Reg. 12,818.
Overall this process resulted in five new NWPs (known collectively as “Replacement Permits”), modification of seven NWPs, two, new General Conditions (“GGs”), and modification of nine existing GCs. These changes to the NWPs process authorized many of the same activities allowed under NWP 26, but the new and modified NWPs were activity-specific. 65 Fed.Reg. 12,818. Among the controversial changes, the Corps narrowed the maximum per-project acreage impact at a half of an acre instead of ten acres, and precon-struction notification was required for impacts greater than one-tenth of an acre instead of one acre.3 The new NWPs be*78came effective on June 7, 2000, and NWP 26 expired the same day. 65 Fed.Reg. 14,255.
NAHB’s complaint was filed on February 28, 2000, and on March 16, 2000, the NSSGA et al. filed its complaint. The two cases were consolidated on June 15, 2000. The NFIB et al. filed its complaint on June 16, 2000, and was consolidated with the other two cases on September 12, 2000. The plaintiffs argue, inter alia, that the NWPs exceed the Corps’ authority under the CWA because the Corps only has jurisdiction over “discharges” of dredged or fill material into “waters of the United States,” the NWPs exceed the Corps’ authority under the CWA because the Corps can only issue NWPs for categories of activities that are similar in nature and will cause only minimal adverse environmental impacts, the Corps did not conduct a flexibility analysis as required by the Regulatory Flexibility Act, and the NWPs violated NEPA because the Corps did not conduct a Programmatic Environmental Impact Statement.4 On February 15, 2001, all three sets of plaintiffs filed motions for summary judgment, and the defendants and intervenors responded with cross-motions for summary judgment on June 14, 2001.
While the parties’ cross-motions for summary judgment were pending, the Corps issued new NWPs and conditions on January 15, 2002. Because the NWPs were reissued, the Court initially assigned the case permitted the parties to submit supplemental complaints and pleadings. While that supplemental briefing was in progress, this case was reassigned to this Court on April 9, 2002. The parties completed their supplemental filings on August 12, 2002.
II. Discussion
The defendants contend that the Court lacks subject matter jurisdiction because the Corps’ issuance of NWPs is not a final agency action. The Court concludes, for the following reasons, that the Corps’ issuance of the new NWPs and general conditions, while constituting the completion of a decisionmaking process, does not constitute a “final” agency action because no legally binding action has taken place as to any given project until either an individual permit application is denied or an enforcement action is instituted.
Under the Administrative Procedures Act (“APA”), courts can only exercise judicial review over a “final agency action for which there is no other adequate remedy in a court.” 5 U.S.C. § 704; see also FTC v. Standard Oil Co., 449 U.S. 232, 288, 101 S.Ct. 488, 66 L.Ed.2d 416 (1980).5 In Bennett v. Spear, the Supreme Court explained further that an agency action is final only if it meets two conditions: The first condition is that “the action must mark the consummation of the *79agency’s decisionmaking process — it must not be of a merely tentative or interlocutory nature.” 520 U.S. 154, 177-78, 117 S.Ct. 1154, 137 L.Ed.2d 281 (1997); Reliable Automatic Sprinkler Co. v. Consumer Product Safety Commission, 324 F.3d 726, 731 (D.C.Cir.2003) (stating that the agency decision must be “definitive”) (quoting Standard Oil Co., 449 U.S. at 239, 101 S.Ct. 488) (internal quotes omitted). The second condition, which overlaps closely with the requirements for ripeness,6 is that “the. action must be one by which rights or obligations have been determined, or from which legal consequences will flow.” Bennett, 520 U.S. at 177-78, 117 S.Ct. 1154; Reliable Automatic Sprinkler Co., 324 F.3d at 731 (stating the action must have “ ‘direct and immediate ... effect on the day-to-day business’ of the parties”) (quoting Standard Oil Co., 449 U.S. at 239, 101 S.Ct. 488). In sum, an agency action is only final “to the extent that it imposes an obligation, denies a right, or fixes some legal relationship.” Reliable Automatic Sprinkler Co., 324 F.3d at 731 (citing Role Models Am., Inc. v. White, 317 F.3d 327, 331-32 (D.C.Cir.2003)).
The first condition of the finality test — that the agency action be a definite declaration of the agency’s policy — is met in this case. After congressionally mandated notice and public hearings, the Corps issued general permits pursuant to Section 404(e). 33 U.S.C. § 1344(e)(1). The Corps set conditions that, if met, allow parties to discharge pollutants, exempting them from the clear-cut prohibition on discharges into navigable waters. In its own words, the Corps set forth the “Final Notice of Issuance and Modification of Nationwide Permits,” 64 Fed.Reg. 47,175; 65 Fed.Reg. 12,818, and declared that the “Nationwide Permits are issued,” 65 Fed. Reg. 12,885. There can be no doubt that these new NWPs constitute an “action” because review under the APA covers all sorts of agency decisions, see Whitman v. American Trucking Ass’ns, 531 U.S. 457, 478, 121 S.Ct. 903, 149 L.Ed.2d 1 (2001) (explaining that “final action” is “meant to cover comprehensively every manner in which an agency may exercise its power”) (citing FTC v. Standard Oil Co. of Cal., 449 U.S. 232, 238, n. 7, 101 S.Ct. 488, 66 L.Ed.2d 416 (1980)). It is equally clear that the Corp has “rendered the last word,” Whitman, 531 U.S. at 478, 121 S.Ct. 903 (quoting Harrison v. PPG Industries, Inc., 446 U.S. 578, 586, 100 S.Ct. 1889, 64 L.Ed.2d 525 (1980) (internal quotes omitted)), on the contours of the nationwide permitting program by establishing conclusively a pollution impact threshold below which a party can discharge pollutants without having to acquire an individual permit from the Corps. Thus the issuance of the NWPs marks the “consummation” of the agency’s action as to that aspect of the Corp’s duties. Bennett, 520 U.S. at 177-178, 117 S.Ct. 1154.
*80However, just because the agency has definitively declared its policy by setting this new threshold through the NWPs does not mean that the action is necessarily final as to any given project. Indeed, the second condition of the finality test requires this Court to determine whether there are any legal consequences inherent in the agency’s decision, and, if so, whether those consequences are sufficient to establish finality. Because Congress specified that the Corps “may” issue general permits, but did not require it to do so, 33 U.S.C. § 1344(e)(1), the Corps’ decision, in effect, to allow certain projects to pollute if its impact is limited in geographic consequence, or if they meet other minimal conditions, does not deprive the parties whose projects exceed the pollution impact threshold set by NWPs of any right that they would otherwise have. Indeed, a party whose project will exceed an NWP threshold is not denied anything until it has exhausted all of its permit options. Thus, the general permit program, in effect, is the first step of a larger permitting process that enables the agency to streamline the overall process by limiting the pool of applicants at the front-end of the process. Those who are not eliminated simply apply for an individual permit. 65 Fed.Reg. 12,821 (“If a prospective permit-tee cannot comply with all of the terms and conditions of the NWPs, then he or she can request another form of Department of the Army (DA) authorization, such as a regional general permit or a standard individual permit.”); 67 Fed.Reg. at 2053 (stating that if prospective permittee does not qualify for a NWP, he can request individual or regional general permit). Since the Corps determines whether to issue these individual permits on a case-by-case basis after site-specific analysis and opportunity for public hearing, 33 C.F.R. §§ 320.4, 323, a party is not legally denied anything until its individual permit is rejected.
In Industrial Highway Corp. v. Danielson, 796 F.Supp. 121 (D.N.J.1992), aff'd, 995 F.2d 217 (3d Cir.1993), a district court considered whether the Corps’ decision— that Industrial Highway could not proceed under a NWP and must acquire an individual permit for its building construction— was a final decision under the APA. Id. at 122. The facts in that case involved a company’s attempt to construct a building. After providing the Corps’ with precon-struction notification, Industrial Highway was informed by the Corps that it must apply for an individual permit because a previous violation remained uncorrected. Id. The court concluded that the Corps’ decision requiring Industrial Highway to apply for an individual permit did not have the “status of law,” id. (quoting Solar Turbines, Inc. v. Seif, 879 F.2d 1073, 1080 (3rd Cir.1989)), because the Corps did not prevent Industrial Highway from proceeding forward with its construction. Id. at 127-28. Moreover, the court concluded that any purported hardship of having to comply with the Corps’ individual permit program was not substantial enough for the Corps’ decision to be considered a final agency action. Id. at 128.
Though the case here involves considerably more parties than in Industrial Highway, the effect is the same. The issuance of the NWPs alone does not necessarily preclude any party from proceeding with a discharge activity. To proceed with an activity, a party simply must apply for an individual permit. As the court in Industrial Highway explained: “The Corps has not directed [the plaintiff] to engage in any act, nor has it forbid Industrial from engaging in any act.” Id. at 127.
Moreover, the Corps’ decision to set a NWP threshold does not constitute an enforcement action against any party. By *81setting a threshold for permitting purposes, it has not necessarily prohibited any party from moving forward with construction or any activity that would involve discharging pollutants. Indeed, until an enforcement action is initiated, or denial of an individual permit occurs, no “legally binding decision” has taken place. Lotz Realty Co. v. United States et al., 757 F.Supp. 692, 696 (E.D.Va.1990) (quoting Avella v. U.S. Army Corps of Engineers, 1990 WL 84499 (S.D.Fla.1990)); Lotz Realty Co., 757 F.Supp. at 696 (finding that Corps’ decision requiring plaintiff to seek individual permit is not a final agency action under the APA because the plaintiff “faces no automatic, unavoidable adverse consequences as a result of the agency action”); cf. Reliable Automatic Sprinkler Co., 324 F.3d at 732 (“No legal consequences flow from the agency’s conduct to date, for there has been no order compelling [a party] to do anything.”).
The defendants’ argument that the delay and cost of having to apply for an individual permit, or to notify the Corps of proposed projects, is hardship enough that the NWP issuance should constitute a final agency action is inherently flawed and inconsistent with a fair understanding of the permitting process. While it is true that the delay for those applying for an individual permit amounted, on average, to one hundred days in fiscal year 1999, 65 Fed.Reg. 12,820, additional delay and cost alone have never been held to render an agency’s decision a final agency action. In Standard Oil, the Supreme Court made clear that having to respond to further administrative requirements “is different in kind and legal effect from the burdens attending what heretofore has been considered to be final agency action.” 449 U.S. at 242, 101 S.Ct. 488. The administrative requirement in Standard Oil was an administrative enforcement hearing, and here it is the requirement that the parties apply for an individual permit. Both requirements incur additional costs and delay, but neither can be considered final agency actions. Just as in Standard Oil, the parties here cannot challenge the agency decision even though they incur the injuries of cost and delay; such injuries are not legally recognizable. See also Abbott Labs., 387 U.S. at 153, 87 S.Ct. 1507 (“[A] possible financial loss is not by itself a sufficient interest to sustain a judicial challenge to government action.”). Simply put, there is no final agency action until a party is either denied an individual permit or an actual enforcement action ensues. See Reliable Automatic Sprinkler, 324 F.3d at 732 (citing Standard Oil, 449 U.S. at 243, 101 S.Ct. 488).
Finally, the Court disagrees with the plaintiffs’ claim that if the Court does not exercise judicial review now, then there will never be an opportunity to do so. There is no legal authority prohibiting a party denied an individual permit from challenging a NWP’s application to its individual project. That is, if a party pursuing a discharging activity — an activity that does not qualify for a NWP — applies for an individual permit and is rejected by the Corps, there is nothing that prohibits the party from challenging both the NWP’s application to its project and the denial of its individual permit application. Cf. Bragg v. Robertson, 54 F.Supp.2d 653, 654 (S.D.W.Va.1999) (finding that the Corps’ decision to require individual permit applications, instead of allowing the plaintiffs to proceed under an NWP, is not necessarily a final agency action because the plaintiffs “have not demonstrated that, once the Corps makes its final determination on the individual permit, an applicant could not challenge the decision requiring an individual permit application”). In the end, as *82the Supreme Court explained clearly in Lujan v. National Wildlife Federation:
Absent [a statutory provision providing for immediate judicial review], a regulation is not ordinarily considered the type of agency action ‘ripe’ for judicial review under the [APA] until the scope of the controversy has been reduced to more manageable proportions, and its factual components fleshed out, by some concrete action applying the regulation to the claimant’s situation in a fashion that harms or threatens to harm him.
497 U.S. 871, 891, 110 S.Ct. 3177, 111 L.Ed.2d 695 (1990).
Here, the time for a plaintiff to challenge a NWP is when the Corps has explicitly prohibited a party from proceeding with its desired activity and thus caused the party actual legal harm. Absent a directive from Congress instructing courts to review these specific administrative decisions, a court must wait until harm actually occurs to an applicant and review the decisions on a case-by-case basis, deferring the proposed “sweeping actions” to the branches of government better suited for such reform. See id. at 894, 110 S.Ct. 3177.
III. Order
For the above-stated reasons, it is this 24th day of November, 2003, hereby
ORDERED that the defendants’ cross-motion for summary judgment [## 60, 62] is GRANTED;
ORDERED that the intervenors’ cross-motion for summary judgment [# 77] is GRANTED;
ORDERED that the plaintiffs’ motions for summary judgment [##46-48] are DENIED;
ORDERED that plaintiff NFIB’s motion to sever case from other two eases is DENIED as moot;
SO ORDERED.
10.2.2 National Ass'n of Home Builders v. United States Army Corps of Engineers 10.2.2 National Ass'n of Home Builders v. United States Army Corps of Engineers
NATIONAL ASSOCIATION OF HOME BUILDERS, Appellant v. UNITED STATES ARMY CORPS OF ENGINEERS et al., Appellees.
Nos. 04-5009, 04-5010, 04-5011.
United States Court of Appeals, District of Columbia Circuit.
Argued April 19, 2005.
Decided July 29, 2005.
*1274Virginia S. Albrecht argued the cause for the appellants. Karma B. Brown, Duane J. Desiderio, Felicia K. Watson, Lawrence R. Liebesman, Rafe Petersen, Ethan Arenson, David E. Frulla, Andrew D. Herman and Elizabeth A. Gaudio were on brief.
Peter L. Gray, Robin S. Conrad, Richard S. Moskowitz, Alan C. Raul and Brian T. Fitzpatrick were on brief for amici curiae Honorable Donald A. Manzullo et al. Prasad Sharma and Stephen A. Bokat entered appearances.
Greer S. Goldman, Attorney, United States Department of Justice, argued the cause for appellees United States Army Corp of Engineers et al. David C. Shilton, Martin McDermott and Stephanie Tai, Attorneys, United States Department of Justice, were on brief.
Howard I. Fox was on brief for appel-lees, Natural Resources Defense Council and Sierra Club.
Eliot Spitzer, Attorney General, State of New York, Peter H. Lehner, Philip M. Bein and Tracy Hughes, Assistant Attorneys General, State of New Mexico, were on brief for amici curiae States of New York and New Mexico.
Before: GINSBURG, Chief Judge, and HENDERSON and GARLAND, Circuit Judges.
Opinion for the court filed by Circuit Judge HENDERSON.
The National Association of Home Builders (NAHB) and others1 (collectively, the appellants) appeal the dismissal of their multi-pronged challenge to the issuance of certain permits by the United States Army Corps of Engineers (Corps) pursuant to section 404(e) of the Clean Water Act (CWA), 33 U.S.C. § 1344. The district court granted summary judgment to the Corps, concluding that it lacked subject matter jurisdiction to entertain any of the appellants’ claims because the Corps’ issuance of the permits did not constitute “final agency action” subject to judicial review under the Administrative Procedure Act (APA), 5 U.S.C. § 704. See Nat’l Ass’n of Home Builders v. United States Army Corps of Eng’rs, 297 F.Supp.2d 74 (D.D.C.2003), reprinted in Joint Appendix (J.A.) at 146-52. We disagree; the appellants’ claims, with one exception, are cognizable. Accordingly, we reverse the district court in part and re*1275mand for further proceedings consistent with this opinion.
I.
The CWA aims to “restore and maintain the chemical, physical, and biological integrity of the Nation’s waters,” 33 U.S.C. § 1251(a), by prohibiting the discharge of pollutants into navigable waters of the United States — except, that is, by permit, see id. § 1311(a). The CWA divides the authority to issue permits to discharge pollutants between the United States Environmental Protection Agency and the United States Secretary of the Army, acting through the Corps, conferring on the latter the power to issue permits for discharges of “dredged or fill material” only. Id. § 1344(a). Responsibility for the day-to-day administration of the permitting regime falls to the Corps’ district and division engineers. See 33 C.F.R. § 320.1(a)(2).
The Corps issues a permit under section 404 of the CWA either on a class-wide (“general permit”) or a case-by-case (“individual permit”) basis. 33 U.S.C. § 1344(a), (e). The Corps issues a general permit “on a State, regional, or nationwide basis for any category of activities involving discharges of dredged or fill material.” Id. § 1344(e)(1); see also 33 C.F.R. § 323.2(h). Before issuing a general permit for a “category of activities,” the Corps must “determine[ ] that the activities in such category are similar in nature, will cause only minimal adverse environmental effects when performed separately, and will have only minimal cumulative adverse effect on the environment.” 33 U.S.C. § 1344(e)(1); see also 33 C.F.R. § 323.2(h)(1). A general permit has a statutorily-limited lifespan— i.e., no longer than five years — and may be revoked or modified if the authorized activities “have an adverse impact on the environment or ... are more appropriately authorized by individual permits.” 33 U.S.C. § 1344(e)(2).
The Corps’ individual permit process is, by contrast, “a longer, more comprehensive procedure.” New Hanover Township v. United States Army Corps of Eng’rs, 992 F.2d 470, 471 (3d Cir.1993). The Corps makes a formal decision on an individual application following site-specific documentation and analysis, public interest review, public notice and comment and, if necessary, a public hearing. See 33 C.F.R. § 320.4; id. §§ 323, 325; see also Home Builders Ass’n of Greater Chicago v. United States Army Corps of Eng’rs, 335 F.3d 607, 612 (7th Cir.2003). If the Corps initially denies an individual application, the applicant may challenge that determination through an administrative appeals process. See 33 C.F.R. § 331.1. Indeed, a disappointed applicant must exhaust his administrative remedies before heading to federal court. See id. § 331.12.
Thus a party desiring to discharge fill or dredged material into our nation’s navigable waters may do so in either of two ways. See New Hanover Township, 992 F.2d at 471. If the proposed discharge activity is covered by a general permit, the party may proceed without obtaining an individual permit or, in some cases, even without giving the Corps notice of the discharge. See 33 C.F.R. § 330.1(e)(1) (“In most cases, permittees may proceed with activities authorized by [nationwide general permits] without notifying the [district engineer].”); New Hanover Township, 992 F.2d at 471 (discharger may “simply operate under the [general] permit without informing the Corps in advance unless the [general] permit in question requires advance approval from the Corps”). On the other hand, if the proposed discharge is not covered by a general permit, the party must secure an individual permit before undertaking the discharge. See 33 C.F.R. *1276§ 323.3(a). A party that discharges without meeting the conditions of a general permit or obtaining an individual permit faces both civil and criminal enforcement actions. See 33 U.S.C. § 1319; 33 C.F.R. § 326.5-6.
This litigation involves several nationwide permits, or NWPs, a species of general permit designed to minimize delays and paperwork for projects with minimal environmental impact. See 33 C.F.R. § 330.1(b). The Corps has issued this kind of permit for five-year intervals since 1977, see, Nat’l Ass’n of Home Builders, 297 F.Supp.2d at 77; Public Notice Concerning Changes to Nationwide Permit 26, 63 Fed. Reg. 39,276, 39,277 (July 22, 1998), including the once widely-used but now defunct NWP 26, see Final Notice of Issuance, Reissuance, and Modification of Nationwide Permits, 61 Fed. Reg. 65,874, 65,892 (Dec. 13, 1996) (noting 13,837 activities were authorized by NWP 26 in 1995 alone). There are currently 43 NWPs in force — covering activities ranging from “Single-family Housing” (NWP 29) to “Mining Activities” (NWP 44) to “Cranberry Production Activities” (NWP 34) — that are subject to 27 General Conditions (GCs)2 — regarding matters like “Soil Erosion and Sediment Controls” (GC 3) and “Notification” (GC 13). See Issuance of Nationwide Permits; Notice, 67 Fed. Reg. 2020, 2077, 2078-94 (Jan. 15, 2002). In their current version, the assorted NWPs, applicable conditions and relevant definitions span nearly 20 pages in the Federal Register. See id. at 2077-94.
In 1996, the Corps proposed to reissue a number of existing NWPs, albeit with modifications, that were otherwise set to expire on January 21, 1997. See Proposal to Issue, Reissue, and Modify Nationwide Permits; Public Hearing, 61 Fed. Reg. 30,780 (June 17, 1996). As to NWP 26, which, at the time, authorized a party to discharge dredged or fill materials affecting up to ten acres of water into headlands and isolated wetlands without an individual permit and required only notice to a Corps district engineer of any discharge causing loss or substantial adverse modification of one to ten acres of wetlands, the Corps gave public notice of — and sought comment on — proposed changes to its “pre-construction notification” timeline and acreage threshold limits. See id. at 30,783. It also notified the public that it planned to “initiate a process to regionalize” NWP 26 to “further improve its effectiveness.” Id.
Following public comment, the .Corps decided to replace NWP 26 with “activity-specific” general permits. See Final Notice of Issuance, Reissuance, and Modification of Nationwide Permits, 61 Fed. Reg. 65,874, 65,875 (Dec. 13, 1996). To allow ample time to develop replacement permits, however, it reissued NWP 26 for a two-year period but with more stringent conditions. See id. at 65,877, 65,891, 65,-895. In July 1998, the Corps published a proposed suite of activity-specific general permits to replace NWP 26, see Proposal to Issue and Modify Nationwide Permits, 63 Fed Reg. 36,040 (July 1, 1998), and extended, once more, the life of NWP 26 until December 30, 1999 “or the effective date of the new and modified NWPs, whichever comes first,” Proposal to Issue and Modify Nationwide Permits; Notice, 64 Fed. Reg. 39,252, 39,260 (July 21, 1999). That same month the Corps also reissued the NWP regarding single-family housing (NWP 29), but reduced the authorized maximum acreage impact from one-half to one-quarter acre. See Final Notice of Modification of Nationwide Permit 29 for *1277Single Family Housing, 64 Fed. Reg. 47,-175 (Aug. 30, 1999).
The Corps issued a second proposed set of activity-specific NWPs to replace NWP 26 one year later. See 64 Fed. Reg. at 39,252. In March 2000, following another round of public comment, the Corps promulgated activity-specific permits consisting of five new NWPs and six modified NWPs, all intended to replace NWP 26. See Final Notice of Issuance and Modification of Nationwide Permits, 65 Fed. Reg. 12,818 (Mar. 9, 2000). With some of the activity-specific NWPs, the Corps reduced the authorized maximum per-project acreage impact from ten acres to one-half acre and required preconstruction notification for impacts greater than one-tenth acre. See 65 Fed. Reg. at 12,818. Although December 30, 1999 preceded the effective date of the replacement permits, the Corps nevertheless decided to have NWP 26 expire the same day the new permits took effect — June 7, 2000. Compare 65 Fed. Reg. at 12,818 (extending NWP 26’s expiration date to June 5, 2000), with Final Notice of Issuance and Modification of Nationwide Permits, 65 Fed. Reg. 14,255 (Mar. 16, 2000) (making June 7, 2000 “the correct effective date for the new and modified NWPs, as well as the correct expiration date for NWP 26.”).
The Corps’ new permits prompted three law suits the district court eventually consolidated into one. The NAHB’s suit was filed on February 28, 2000, followed by the NSSGA’s suit on March 16, 2000, and the NFIB’s suit on June 14, 2000. Together, the three suits allege four claims against the Corps, to wit: (1) it exceeded its statutory authority under the CWA by imposing certain permit conditions; (2) it acted arbitrarily and capriciously, in violation of the APA, 5 U.S.C. § 706(2)(A), by failing to provide a rational basis for its permit acreage thresholds; (3) it violated the Regulatory Flexibility Act (RFA), 5 U.S.C. §§ 601 et seq., by failing to evaluate the potential impact of the permits on small businesses and other small entities as well as alternatives to the permits; and (4) it violated the National Environmental Policy Act (NEPA), 42 U.S.C. §§ 4231 et seq., by failing to prepare a Programmatic Environmental Impact Statement (PEIS) for the permits. The National Resources Defense Council and the Sierra Club (the intervenors) intervened in the district court proceedings in support of the Corps.
The appellants moved for summary judgment on February 15, 2001. The Corps and intervenors responded with motions for summary judgment of their own on June 14, 2001. While the parties’ cross-motions for summary judgment lay pending, on January 15, 2002, the Corps reissued all 43 NWPs, including the eleven March 2000 NWPs it issued to replace NWP 26, to make their expiration dates coincide, thereby “reducing] confusion regarding the expiration of the NWPs and the administrative burden of reissuing NWPs at different times.”3 See 67 Fed. Reg. at 2020. In November 2003, the district court granted summary judgment to the Corps, concluding that “the Corps’ issuance of the new NWPs and general conditions, while constituting the completion of a decisionmaking process, does not constitute a ‘final’ agency action because no legally binding action has taken place as to any given project until either an individual permit application is denied or an enforcement action is instituted.” Nat’l *1278Ass'n of Home Builders, 297 F.Supp.2d at 78. Calling the “general permit program ... the first step of a larger permitting process that enables the agency to streamline the overall process by limiting the pool of applicants at the front-end of the process,” the district court concluded that a party not eliminated from the applicant pool must “simply apply for an individual permit” and, consequently, “is not legally denied anything until [his] individual permit is rejected.” Id. at 80.
The appellants now appeal the district court’s judgment, which we review de novo. See, e.g., Mylan Labs., Inc. v. Thompson, 389 F.3d 1272, 1278 (D.C.Cir.2004).
II.
The jurisdictional infirmity the lower court found fatal to this case was the want of a final agency action subject to judicial review; that is only one of the issues, however, joined by the parties and requiring our resolution. First, we consider whether the Corps took “final agency action” subject to challenge under the APA and, if so, whether the appellants’ challenge is otherwise ripe for judicial review. Next, we address whether the appellants may challenge the Corps’ compliance with the RFA and, again, whether that challenge is ripe. Finally, we review the appellants’ standing vel non to challenge the Corps’ compliance with NEPA.
A.
Where, as here, no more specific statute provides for judicial review, the APA empowers a federal court to review a “final agency action for which there is no other adequate remedy in a court.” 5 U.S.C. § 704; see Home Builders Ass’n of Greater Chicago, 335 F.3d at 614. “[T]wo conditions,” the United States Supreme Court tells us, “must be satisfied for agency action to be ‘final.’ ” Bennett v. Spear, 520 U.S. 154, 177, 117 S.Ct. 1154, 137 L.Ed.2d 281 (1997). “First, the action must mark the consummation of the agency’s decisionmaking process — it must not be of a merely tentative or interlocutory nature. And second, the action must be one by which rights or obligations have been determined, or from which legal consequences will flow.” Id. at 177-78, 117 S.Ct. 1154 (internal quotation marks & citations omitted). In other words, an agency action is final if, as the Supreme Court has said, it is “ ‘definitive’ ” and has a “ ‘direct and immediate ... effect on the day-to-day business’ ” of the party challenging it, FTC v. Standard Oil Co., 449 U.S. 232, 239, 101 S.Ct. 488, 66 L.Ed.2d 416 (1980) (quoting & citing Abbott Labs. v. Gardner, 387 U.S. 136, 152, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967), overruled on other grounds by Califano v. Sanders, 430 U.S. 99, 105, 97 S.Ct. 980, 51 L.Ed.2d 192 (1977)); see also Reliable Automatic Sprinkler Co. v. Consumer Prod. Safety Comm’n, 324 F.3d 726, 731 (D.C.Cir.2003), or if, as our court has said, “it imposes an obligation, denies a right or fixes some legal relationship.” Reliable Automatic Sprinkler Co., 324 F.3d at 731 (citing Role Models Am., Inc. v. White, 317 F.3d 327, 331-32 (D.C.Cir.2003)). There can be little doubt that under these standards the Corps’ issuance of the NWPs challenged by the appellants constitutes final agency action subject to judicial review.4
We need not tarry long on the finality test’s first prong; plainly, the Corps’ issuance of the revised NWPs “mark[s] the *1279consummation of [its] decisionmaking process.” Bennett, 520 U.S. at 178, 117 S.Ct. 1154. There is nothing “tentative” or “interlocutory” about the issuance of permits allowing any party who meets certain conditions to discharge fill and dredged material into navigable waters. The interve-nors argue, however, that, by “setting terms and conditions for NWPs, the Corps did not finally decide that a would-be dis-charger must comply with those terms and conditions, nor did the Corps finally deny authorization for discharges that exceed those terms and conditions.” Intervenors’ Br. at 15. In their view, “[a] would-be discharger remains free to pursue an individual or general permit that is free of those restrictions.” Intervenors’ Br. at 15. The district court similarly opined that a party whose activities do not meet the conditions set by the NWPs has not been “denied anything until [he] has exhausted all of [his] permit options.” Nat’l Ass’n of Home Builders, 297 F.Supp.2d at 80. This is so, said the district court, because “the general permit program, in effect, is the first step of a larger permitting process that enables the agency to streamline the overall process by limiting the pool of applicants at the front-end of the process.” Id. If the issuance of the NWPs had merely altered the procedural framework for obtaining the Corps’ permission to discharge fill or dredged material into navigable waters, the district court’s reasoning— now advanced by the intervenors — might be sound. A requirement that a party participate in additional administrative proceedings “is different in kind and legal effect from the burdens attending what heretofore has been considered to be final agency action.” Standard Oil Co., 449 U.S. at 242, 101 S.Ct. 488. We have in fact noted that “the doctrine of finality” would be no more than “an empty box” if the mere denial of a procedural advantage constituted final agency action subject to judicial review. ALCOA v. United States, 790 F.2d 938, 942 (D.C.Cir.1986).
But the NWPs do not simply work a change in the Corps’ permitting procedures, thereby disadvantaging some within the class of would-be dischargers. The NWPs are not a definitive, but otherwise idle, statement of agency policy — they carry easily-identifiable legal consequences for the appellants and other would-be dis-chargers. Admittedly, our precedent announces no self-implementing, bright-line rule in this regard; the finality inquiry is a “pragmatic” and “flexible” one. See, e.g., Ciba-Geigy Corp. v. EPA, 801 F.2d 430, 435-36 (D.C.Cir.1986) (“[W]e are to apply the finality requirement in a ‘flexible’ and ‘pragmatic’ way.” (quoting & citing Abbott Labs., 387 U.S. at 149-50, 87 S.Ct. 1507)). Nevertheless, if an EPA directive forbidding the use of third-party human test data to evaluate pesticides’ effects constituted final agency action subject to judicial review before the EPA invoked it against any pesticide applicant, see CropLife Am. v. EPA, 329 F.3d 876, 881-83 (D.C.Cir.2003), and a Federal Communications Commission decision putting the burden on telephone companies to show their entitlement to certain costs was suitable for judicial review before any telephone company was denied costs, see Mountain States Tel. & Tel. Co. v. FCC, 939 F.2d 1035, 1041 (D.C.Cir.1991), the Corps’ issuance of NWPs likewise satisfies the second prong of the finality test. To our mind, all three constitute challenges to agency action “with legal consequences that are binding on both petitioners and the agency.” CropLife Am., 329 F.3d at 882; see also Mountain States Tel. & Tel. Co., 939 F.2d at 1041.
The Corps’ NWPs create legal rights and impose binding obligations insofar as they authorize certain discharges of dredged and fill material into navigable *1280waters without any detailed, project-specific review by the Corps’ engineers. See, e.g., 65 Fed. Reg. at 12,818 (“The terms and limits of the new and modified NWPs are intended to authorize activities that have minimal adverse effects on the aquatic environment, individually and cumulatively.”). The “direct and immediate” consequence of these authorizations for the appellants’ “day-to-day business” is not hard to understand: While some builders can discharge immediately, others cannot. If the appellants’ planned activities do not meet the applicable NWP’s conditions and thresholds, they have two options. They can either put their projects on hold and run the Corps’ individual-permit gauntlet or modify the projects to meet the conditions. Either way, through increased delay or project modification, the NWPs directly affect the investment and project development choices of those whose activities are subject to the CWA. Indeed, the Corps itself appreciated that its permits would influence project design. “Many project proponents,” it noted, “will design their projects to comply with the % acre limit so that they can qualify for an NWP and receive authorization more quickly than they could through the standard permit process.” 65 Fed. Reg. at 12,821. We would be hard pressed, and in fact decline, to conclude that the NWPs do not “impose[ ] an obligation, den[y] a right or fbc[ ] some legal relationship.” Reliable Automatic Sprinkler Co., 324 F.3d at 731.
In addition, the intervenors argue that environmental groups, such as themselves, may challenge the Corps’ issuance of NWPs as final agency action but the appellants may not. This is so, they say, because an environmental group would challenge the discharges authorized by the Corps — that is, it would oppose an agency action — while the appellants challenge the Corps’ failure to authorize certain discharges — that is, they seek to compel agency action. The appellants seek to compel agency action in this instance, the intervenors maintain, because “the Corps did not finally decide that a would-be dis-charger must comply with [the NWP] terms and conditions, nor did the Corps finally deny authorization for discharges that exceed those terms and conditions.” Intervenors’ Br. at 15. Thus “would-be dischargers” such as the appellants “remain free to pursue an individual or general permit.” Intervenors’ Br. at 15. It is true that a party seeking to challenge an agency’s failure to act faces a different burden from that borne by a challenger of agency action. An action to “compel agency action unlawfully withheld or unreasonably delayed,” 5 U.S.C. § 706(1), is similar to a petition for mandamus and we apply a six-factor standard to determine if “the agency has a duty to act and [if] it has ‘unreasonably delayed’ in discharging that duty.” In re Am. Rivers, 372 F.3d 413, 418 (D.C.Cir.2004); see also Telecomms. Research & Action Ctr. v. FCC, 750 F.2d 70, 76 (D.C.Cir.1984). A challenge to agency action, by contrast, is simply resolved according to the APA. But the case on which the intervenors principally ground their argument — Norton v. S. Utah Wilderness Alliance, 542 U.S. 55, 124 S.Ct. 2373, 159 L.Ed.2d 137 (2004) — tends only to demonstrate why the oppose action/compel action dichotomy does not make the Corps’ action non-final as to the appellants. In S. Utah Wilderness Alliance, various environmental groups challenged the Bureau of Land Management’s failure to protect public lands from damage allegedly caused by off-road vehicles. See id at 2377-78. At the outset, the Supreme Court noted that “[failures to act are sometimes remediable under the APA, but not always,” and ultimately held that the BLM’s failure was not renewable because “a claim under § 706(1) can pro*1281ceed only where a plaintiff asserts that an agency failed to take a discrete agency action that it is required to take,” id. at 2379 (emphases in S. Utah Wilderness Alliance), and the BLM did not fail to take “required” action, id. at 2380, 2384. Here the appellants challenge not the Corps’ failure to act — ie., “the omission of an action without formally rejecting a request,” id. at 2379 — as unreasonable under APA section 706(1); instead, they attack the NWPs the Corps did issue as arbitrary and capricious and beyond its permitting authority under APA section 706(2)(A). Because the Corps’ NWPs mark the completion of the Corps’ decision-making process and affect the appellants’ day-to-day operations, they constitute final agency action regardless of the fact that the Corps’ action might carry different (or no) consequences for a different challenger, such as an environmental group. In any event, the notion that “would-be dischargers” like the appellants nevertheless “remain free to pursue an individual or general permit” suggests a ripeness — not a finality — problem. See Office of Communication of United Church of Christ v. FCC, 911 F.2d 813, 816-17 (D.C.Cir.1990) (FCC’s refusal to adopt anti-trafficking policy and presumption that broadcast license transfer in less than three years is contrary to public interest are matters ripe for review). We turn to that issue now.
B.
Both the Corps and the intervenors, recognizing that we may affirm the district court on an alternative ground, see, e.g., Tymshare, Inc. v. Covell, 727 F.2d 1145, 1150 (D.C.Cir.1984) (“In this appeal, appel-lee has sought to justify the judgment below upon a ground argued below but not relied upon by the opinion of the district court. We may of course sustain on such a ground.”) (citing Langnes v. Green, 282 U.S. 531, 538-39, 51 S.Ct. 243, 75 L.Ed. 520 (1931)), maintain that the appellants’ challenge is not ripe for judicial review. Not so.
The doctrine of ripeness shares with its statutory counterpart, viz., finality, “the dual concerns of prematurity of judicial intervention in agency processes and the proper and principled exercise of judicial power.” USAA Fed. Sav. Bank v. McLaughlin, 849 F.2d 1505, 1508 (D.C.Cir.1988). That is, “its basic rationale,” the Supreme Court tells us, “is to prevent the courts, through avoidance of premature adjudication, from entangling themselves in abstract disagreements over administrative policies, and also to protect agencies from judicial interference until an administrative decision has been formalized and its effects felt in a concrete way by the challenging parties.” Abbott Labs., 387 U.S. at 148-49, 87 S.Ct. 1507. The ripeness doctrine has two components: “[It] requires us to consider ‘the fitness of the issues for judicial review and the hardship to the parties of withholding court consideration.’ ” Village of Bensenville v. FAA, 376 F.3d 1114, 1119 (D.C.Cir.2004) (quoting & citing Abbott Labs., 387 U.S. at 149, 87 S.Ct. 1507). Neither of these considerations — which we address in turn — counsels in favor of postponement here.
The appellants’ challenge easily satisfies the first ripeness prong — fitness. “[T]he fitness of an issue for judicial decision depends on whether it is ‘purely legal, whether consideration of the issue would benefit from a more concrete setting, and whether the agency’s action is sufficiently final.’ ” Atl. States Legal Found. v. EPA, 325 F.3d 281, 284 (D.C.Cir.2003) (quoting & citing Clean Air Implementation Project v. EPA, 150 F.3d 1200, 1204 (D.C.Cir.1998)). The appellants’ APA challenge is “purely legal,” Atl. States Legal Found., 325 F.3d at 284: They allege that the *1282Corps exceeded its statutory authority in drafting the NWPs and that the Corps failed to offer a reasoned basis for their conditions and restrictions. See J.A. 8-9, 27, 44-51, 73-78; Appellants’ Br. at 14-16. We have repeatedly held that “[ejlaims that an agency’s action is arbitrary and capricious or contrary to law present purely legal issues.” See, e.g., Atl. States Legal Found., 325 F.3d at 284 (citing Fox Television Stations, Inc. v. FCC, 280 F.3d 1027, 1039 (D.C.Cir.2002)). We have also often observed that a purely legal claim in the context of a facial challenge, such as the appellants’ claim, is “presumptively reviewable.” Nat'l Mining Ass’n v. Fowler, 324 F.3d 752, 757 (D.C.Cir.2003); see also Mountain States Tel. & Tel. Co., 939 F.2d at 1041 (“In light of the wholly legal and facial nature of the present challenge, we cannot agree that our ability to review the agency’s decision would be increased by delay.”).
While we have cautioned that sometimes “even purely legal issues may be unfit for review,” Atl. States Legal Found., 325 F.3d at 284, we cannot accept the Corps’ argument that the appellants’ purely legal challenge is unfit for review at this time. It initially argues that the NWPs are not fit for review because their applicability to a given activity remains within the Corps’ discretion. We have already debunked this theory. In Appalachian Power Co. v. EPA, 208 F.3d 1015, 1022 (D.C.Cir.2000), we explained that “the fact that a law may be altered in the future has nothing to do with whether it is subject to judicial review at the moment.” Id. In addressing the ripeness of an EPA Guidance, we recently explained that “if the possibility ... of future revision in fact could make agency action non-final as a matter of law, then it would be hard to imagine when any agency rule ... would ever be final as a matter of law.” Gen. Elec. Co. v. EPA, 290 F.3d 377, 380 (D.C.Cir.2002). That the Corps retains some measure of discretion with respect to the NWPs does not make the appellants’ purely legal challenge unripe.
The Corps and the intervenors further argue that the appellants’ APA challenge remains “hopelessly abstract” until “a member submits an actual individual permit application proposing a specific project, has its application denied or unlawfully conditioned, and completes the administrative appeal process provided by Corps regulations.” Appellees’ Br. at 24; see also Intervenors’ Br. at 20-23. While it is undoubtedly true that a “claim is not ripe for adjudication if it rests upon contingent future events that may not occur as anticipated, or indeed not occur at all,” we see no reason here to “wait for a rule to be applied to see what its effect will be.” Atl. States Legal Found., 325 F.3d at 284 (internal quotation marks & alteration omitted). No further factual development is necessary to evaluate the appellants’ challenge. All of the facts necessary for judicial review were before the Corps when it issued the permits and, on APA review, its action necessarily stands or falls on that administrative record and its statutory permitting authority under the CWA. See Fox Television Stations, 280 F.3d at 1039 (issue fit for judicial review because whether agency action is arbitrary and capricious or contrary to law is “purely legal” question); cf. Elec. Power Supply Ass’n v. FERC, 391 F.3d 1255, 1263 (D.C.Cir.2004) (claim fit for review “as it can be wholly resolved by an analysis of the Sunshine Act, the Act’s legislative history, and its construction by relevant case law”).
Relying on Lujan v. Nat’l Wildlife Fed’n, 497 U.S. 871, 110 S.Ct. 3177, 111 L.Ed.2d 695 (1990), the intervenors also argue that the appellants’ challenge is not ripe because the CWA does not explicitly *1283provide for facial review of a NWP and because the appellants need not adjust their conduct immediately. In Lujan, the Supreme Court rejected the National Wildlife Federation’s attempt to challenge the “continuing (and thus constantly changing) operations of the [Bureau of Land Management] in reviewing withdrawal revocation applications and the classifications of public lands and developing land use plans.” Id. at 890, 110 S.Ct. 3177. The Court explained:
[Respondent cannot seek wholesale improvement of this program by court decree .... Under the terms of the APA, respondent must direct its attack against some particular “agency action” that causes it harm. Some statutes permit broad regulations to serve as the “agency action,” and thus to be the object of judicial review directly, even before the concrete effects normally required for APA review are felt. Absent such a provision, however, a regulation is not ordinarily considered the type of agency action “ripe” for judicial review under the APA until the scope of the controversy has been reduced to more manageable proportions, and its factual components fleshed out, by some concrete action applying the regulation to the claimant’s situation in a fashion that harms or threatens to harm him. (The major exception, of course, is a substantive rule which as a practical matter requires the appellant to adjust his conduct immediately. Such agency action is “ripe” for review at once, ivhether or not explicit statutory revieiv apart from the APA is provided.)
Id. at 891, 110 S.Ct. 3177 (internal citations omitted; second emphasis added). But the appellants, unlike the National Wildlife Federation in Lujan, do not seek “wholesale” revision of the Corps’ permitting framework. Rather, they challenge a specific agency action' — i.e., the Corps’ issuance of NWPs authorizing certain discharges of dredged and fill material — that requires them to adjust their conduct immediately, as discussed above. And “[s]ueh agency action,” the Court observed in Lujan, “is ‘ripe’ for review at once, whether or not explicit statutory review apart from the APA is provided.” Id. Accordingly, “[i]n light of the wholly legal and facial nature of the present challenge,” the appellants’ APA claim is fit for judicial review now. Mountain States Tel. & Tel. Co., 939 F.2d at 1041.
Turning to the hardship prong of the ripeness test, we conclude that this requirement is also satisfied. Any institutional interest in postponing review must be balanced against the resultant hardship to the appellants in order to determine whether immediate review is proper. See Consol. Rail Corp. v. United States, 896 F.2d 574, 577 (D.C.Cir.1990) (“If we have doubts about the fitness of the issue for judicial resolution, then we balance the institutional interests in postponing review against the hardship to the parties that will result from delay.”). On the one hand, no institutional interest of the court supports postponement. See Mountain States Tel. & Tel. Co., 939 F.2d at 1041. The administrative process has run its course, resulting in general permits and conditions that the appellants have challenged as arbitrary, capricious and contrary to law under the APA. Their success depends on the administrative record and the statutory parameters of the Corps’ permitting authority under the CWA. On the other hand, we cannot agree with the Corps that the appellants face no hardship as a result of postponed judicial review because, as it would have us believe, legal consequences flow only from “a collective permitting decision on a specific project” and consequently any alleged harm is purely “hypothetical at this time.” Appel-*1284lees’ Br. at 28. Nor do we agree with the intervenors’ similar suggestion that any alleged harm is ameliorated by the appellants’ ability to “pursue further agency remedies.” Intervenors’ Br. at 23. To the contrary, the fact of the matter is that in the absence of judicial review the appellants are left with the choices we identified earlier: They must either modify their projects to conform to the NWP thresholds and conditions (as the Corps contemplates they will do) or refrain from building until they can secure individual permits. The NWPs therefore affect the appellants’ activities in a “direct and immediate” way. See Elec. Power Supply Ass’n, 391 F.3d at 1263 (hardship demonstrated where “implementation of the market monitor exemption will have a direct and immediate impact on the appellant that rises to the level of hardship.” (internal quotation marks & alteration & citations omitted)); Better Gov’t Ass’n v. Dep’t of State, 780 F.2d 86, 93 (D.C.Cir.1986) (DOJ guidelines caused hardship where “ ‘direct and immediate impact’ ” on appellants’ “primary conduct” would be “felt immediately” (citing & quoting Abbott Labs., 387 U.S. at 152, 87 S.Ct. 1507; Toilet Goods Ass’n, Inc. v. Gardner, 387 U.S. 158, 164, 87 S.Ct. 1520, 18 L.Ed.2d 697 (1967))); cf. Texas v. United States, 523 U.S. 296, 301, 118 S.Ct. 1257, 140 L.Ed.2d 406 (1998) (no hardship where party “not required to engage in, or to refrain from, any conduct”); Pfizer Inc. v. Shalala, 182 F.3d 975, 979 (D.C.Cir.1999). Accordingly, we hold that the appellants’ APA challenge is ripe for judicial review.
C.
For “any rule subject” to the RFA, “a small entity that is adversely affected or aggrieved by final agency action is entitled to judicial review of agency compliance with the requirements of sections 601, 604, 605(b), 608(b), and 610.” 5 U.S.C. § 611(a)(1). The Corps and the interve-nors have an argument apiece as to why the appellants cannot challenge the Corps’ compliance with the RFA under this provision. We reject both and hold instead that the appellants’ RFA claim, like their APA claim, is justiciable.
The NWPs, the Corps says, do not constitute a “rule” subject to review under section 604 of the RFA for two reasons, both of which hinge on the RFA’s definition of a rule as “any rule for which the agency publishes a general notice of proposed rulemaking pursuant to section 553(b) of [the APA], or any other law.” 5 U.S.C. § 601(2). The Corps initially contends that the NWPs fall within the APA’s definition of “adjudication” — defined as an “agency process for the formulation of an order,” id. § 551(7) — rather than “rule,” which is defined as “the whole or a part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy,” id. § 551(4). Each NWP constitutes an “adjudication,” so the Corps’ argument goes, because it fits the APA’s definition of adjudication as the formulation of an “order,” id. § 551(7), an “order” includes a “licensing” disposition, id. § 551(6), and a “license” includes a “permit,” id. § 551(8). We reject this elaborate statutory construction for the more straightforward one.
Each NWP easily fits within the APA’s definition of “rule.” This is so because each NWP, which authorizes a permittee to discharge dredged and fill material (and thereby does not allow others without an individual permit), is a legal prescription of general and prospective applicability which the Corps has issued to implement the permitting authority the Congress entrusted to it in section 404 of the CWA. See 33 U.S.C. § 1344(e). As such, each NWP *1285constitutes a rule: An “agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy.” 5 U.S.C. § 551(4); see generally Hercules, Inc. v. EPA, 598 F.2d 91, 117 (D.C.Cir.1978). It is of course the Corps’ decision whether to proceed by rule or adjudication, see SEC v. Chenery Corp., 332 U.S. 194, 203, 67 S.Ct. 1575, 91 L.Ed. 1995 (1947), but “rules is rules,” no matter their gloss. See Granholm, ex rel. Mich. Dep’t of Natural Res. v. FERC, 180 F.3d 278, 282 (D.C.Cir.1999) (quoting & citing Bartlett J. Whitting, MODERN PROVERBS AND PROVERBIAL SAYINGS 541 (1989)).
Relying again on section 601(2) of the RFA, the Corps asserts that the NWPs are not rules because it did not issue any notice of proposed rulemaking pursuant to APA’s rulemaking provision, 5 U.S.C. § 553, or publish them in the Code of Federal Regulations. We have explained that an agency must comply with the “procedures laid down” in the APA only when it promulgates “legislative rules.” Appalachian Power Co., 208 F.3d at 1020. “Legislative rules,” we have said, “are those that grant rights, impose obligations, or produce other significant effects on private interests.” Batterton v. Marshall, 648 F.2d 694, 701-02 (D.C.Cir.1980).
Despite our declarations that “[o]nly ‘legislative rules’ have the force and effect of law” and “[a] ‘legislative rule’ is one the agency has duly promulgated in compliance with the procedures laid down in the statute or in the Administrative Procedure Act,” Appalachian Power Co., 208 F.3d at 1020, we have not hesitated to consider an agency pronouncement issued without meeting required APA procedures a rule. See id. at 1020 n. 11 (‘We have also used ‘legislative rule’ to refer to rules the agency should have, but did not, promulgate through notice and comment rulemaking.”) (citing Am. Mining Cong. v. Dep’t of Labor, 995 F.2d 1106, 1110 (D.C.Cir.1993)). While an “agency’s characterization of an official statement as binding or nonbinding has been given some weight, of far greater importance is the language used in the statement itself.” Brock v. Cathedral Bluffs Shale Oil Co., 796 F.2d 533, 537-38 (D.C.Cir.1986) (citation omitted; emphasis added). As we said in Appalachian Power Co.:
If an agency ... treats the document in the same manner as it treats a legislative rule, if it bases enforcement actions on the policies or interpretations formulated in the document, if it leads private parties or State permitting authorities to believe that it will declare permits invalid unless they comply with the terms of the document, then the agency’s document is for all practical purposes “binding.”
208 F.3d at 1021. The NWPs authorize certain discharges of dredged and fill material and in so doing “grant rights, impose obligations, [and] produce other significant effects on private interests.” Batterton, 648 F.2d at 701-02; see also Appalachian Power Co., 208 F.3d at 1021.
The intervenors, for their part, contend that “even if an NWP could be considered a ‘rule’ within the meaning of the RFA, [the appellants’] claims here do not challenge final agency action, ... and thus are not cognizable under the RFA’s judicial review provision.” Intervenors’ Br. at 28 (citing 5 U.S.C. § 611(a)(3)(A)). We have already explained at length that, as the Corps’ NWPs represent its final word, there can be little doubt that the appellants do challenge a final agency action. Accordingly, we hold that the appellants are entitled to press their RFA challenge now as the Corps’ issuance of the NWPs constitutes final agency action in the form of a legislative rule and their challenge *1286focuses on the Corps’ compliance with sections 604 and 605 of the RFA. See J.A. 27-28.
Although both the Corps and the inter-venors appear not to question the ripeness of the appellants’ RFA claim, we briefly explain why we think the RFA claim is ripe. The Supreme Court has admonished that “ ‘procedural rights’ are special,” Lujan v. Defenders of Wildlife, 504 U.S. 555, 572 n. 7, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992), and that “a person with standing who is injured by a failure to comply with the NEPA procedure may complain of that failure at the time the failure takes place, for the claim can never get riper.” Ohio Forestry Ass’n, Inc. v. Sierra Club, 523 U.S. 726, 737, 118 S.Ct. 1665, 140 L.Ed.2d 921 (1998). The RFA, similar to NEPA in the environmental sphere, requires an agency to evaluate the adverse economic effects of and less harmful alternatives to its actions before taking them. See Associated Fisheries of Maine, Inc. v. Daley, 127 F.3d 104, 114 (1st Cir.1997) (“[A] useful parallel can be drawn between RFA § 604 and the National Environmental Policy Act, which furthers a similar objective .... ”). Thus, as with a NEPA challenge, the appellants may complain of the Corps’ alleged failure to comply with the procedures set forth in sections 604 and 605 of the RFA at the time the alleged failure occurred, i.e., when the Corps issued the NWPs without complying with those procedures. In sum, the appellants’ RFA challenge “can never get riper.” Ohio Forestry Ass’n, 523 U.S. at 737, 118 S.Ct. 1665.
D.
Finally, we address the Corps’ assertion that the appellants lack prudential standing to maintain their NEPA challenge.5 Three propositions bearing on federal court jurisdiction are by now obvious: Want of jurisdiction robs a federal court of the power to act, see, e.g., B & J Oil & Gas v. FERC, 353 F.3d 71, 74-75 (D.C.Cir.2004), standing is a prerequisite to jurisdiction, see, e.g., Crow Creek Sioux Tribe v. Brownlee, 331 F.3d 912, 915-16 (D.C.Cir.2003), and the appellants bear the burden of establishing their standing to sue, see, e.g., KERM, Inc. v. FCC, 353 F.3d 57, 59 (D.C.Cir.2004). A fourth is now equally manifest in our Circuit. When a complainant’s standing is not “self-evident,” he must “supplement the record to the extent necessary to explain and substantiate [his] entitlement to judicial review.” Sierra Club v. ERA 292 F.3d 895, 900 (D.C.Cir.2002). That is, in Sierra Club, we put on notice all complainants whose standing is unclear that they must prove their standing by a “substantial probability,” id. at 899, and that they should do so “by the submission of [their] arguments and any affidavits or other evidence appurtenant thereto at the first appropriate point in the review proceeding,” id. at 900. Our Sierra Club rule is rooted in notions of fairness and judicial economy not difficult to grasp: As the complainant is ordinarily in possession of the facts on which he relies for standing, making those facts manifest at the outset saves the parties and the court from squandering time and energy, either by “flail[ing] at the unknown in an attempt to prove the negative” or by needlessly wrangling over an uncontested point. Id. at 901.
We think that it is fairly “self-evident” that the various appellants as representatives of the regulated parties satis*1287fy the “irreducible constitutional minimum” of Article III standing, Lujan, 504 U.S. at 560, 112 S.Ct. 2130 (injury-in-fact, causation, redressability) and the additional requirements for representational standing, see Hunt v. Wash. State Apple Adver. Comm’n, 432 U.S. 333, 342-43, 97 S.Ct. 2434, 53 L.Ed.2d 383 (1977) (one member with standing to sue in his own right, association seeks to protect interests germane to its purpose, no individual member need participate in lawsuit). But as the Supreme Court has explained, constitutional standing is not the end of the game because the “question of standing ‘involves both constitutional limitations on federal-court jurisdiction and prudential limitations on its exercise.’ ” Bennett, 520 U.S. at 162, 117 S.Ct. 1154 (quoting & citing Warth v. Seldin, 422 U.S. 490, 498, 95 S.Ct. 2197, 45 L.Ed.2d 343 (1975)). Prudential standing requires “that a plaintiffs grievance must arguably fall within the zone of interests protected or regulated by the statutory provision.” Bennett, 520 U.S. at 162, 117 S.Ct. 1154; Nuclear Energy Inst. v. EPA, 373 F.3d 1251, 1266 (D.C.Cir.2004). The zone-of-interest test, however, is intended to “exclude only those whose interests are so marginally related to or inconsistent with the purposes implicit in the statute that it cannot reasonably be assumed that Congress intended to permit the suit.” Clarke v. Sec. Indus. Ass’n, 479 U.S. 388, 399, 107 S.Ct. 750, 93 L.Ed.2d 757 (1987). And it is by no means self-evident to us that the appellants have prudential standing to advance their NEPA challenge.
The Corps and the intervenors agree with our conclusion but for reasons with which we do not agree. The Corps offers that the appellants do not fall within NEPA’s zone-of-interest because their claims are more likely to frustrate than effectuate NEPA’s purposes, their asserted injury is “purely economic” and their interest is merely “in avoiding ‘unnecessary delays, regulatory uncertainty, and considerable cost to [their] members.’ ” Appellees’ Br. at 35-36 (quoting NSSGA’s complaint; alteration' in Appellees’ Br.). The intervenors similarly assert that the appellants do not constitute “an appropriate representative of the environmental interests underlying the statute.” Inter-venors’ Br. at 28 n.14. The premise underlying this reasoning is flawed — commercial entities are not per se excluded from NEPA’s zone-of-interest.
“[A]n allegation of injury to monetary interest alone may not,” of course, “bring a party within the zone of environmental interests as contemplated by NEPA for purposes of standing.” Realty Income Trust v. Eckerd, 564 F.2d 447, 452 (D.C.Cir.1977). But we have often observed that “a party is not precluded from asserting cognizable injury to environmental values because his ‘real’ or ‘obvious’ interest may be viewed as monetary” or “ ‘disqualified’ from asserting a legal claim under NEPA because the ‘impetus’ behind the NEPA claim may be economic.” Id.; see also Mountain States Legal Found. v. Glickman, 92 F.3d 1228, 1236 (D.C.Cir.1996). “[P]arties motivated by purely commercial interests routinely satisfy the zone of interests test,” we have said, as “[cjongruence of interests, rather than identity of interests, is the benchmark.” Amgen, Inc. v. Smith, 357 F.3d 103, 109 (D.C.Cir.2004). We have even observed that “it surely does not square with the broad Congressional purpose in NEPA of assuring that environmental values would be adequately and pervasively considered in federal decision-making for private parties who may not be ‘pure of heart’ to be excluded from vindicating the Act.” Realty Income Trust, 564 F.2d at 453.
*1288Thus the appellants’ problem is not that their “economic interests ... blight [their] qualifying ones,” Mountain States Legal Found., 92 F.3d at 1236; rather, they have failed to demonstrate by a “substantial probability” that they have any qualifying ones, Sierra Club, 292 F.3d at 899. Prudential standing need only be shown by one appellant and, as only the NPPC presses the NEPA challenge, it is no surprise that the appellants rely solely on NPPC’s averments in their effort to demonstrate prudential standing. See Mountain States Legal Found., 92 F.3d at 1232 (Because “prudential standing can be shown for at least one appellant,” court need “not consider the standing of the other appellants to raise th[is] claim.” (citing Watt v. Energy Action Educ. Found., 454 U.S. 151, 160, 102 S.Ct. 205, 70 L.Ed.2d 309 (1981); Vill. of Arlington Heights v. Metro. Hous. Dev. Corp., 429 U.S. 252, 264 n. 9, 97 S.Ct. 555, 50 L.Ed.2d 450 (1977))). The NPPC’s membership is principally composed of local government agencies that “are involved in municipal, industrial and agricultural water supply, flood control, irrigation, wastewater and stormwater management, street and highway construction and maintenance, and environmental quality amenities.” J.A. 125. To support its contention that it falls within NEPA’s zone-of-interest to challenge the NWPs, it relies on the averments of its Executive Director, Robert Tonsing, in paragraph eight of his affidavit:
[D]ue to the inflexible one-half acre rule, the incentive for NPPC members to narrowly tailor their projects so as to fit under the “minimal effects” acreage cap has been significantly reduced. In many cases, under the three-acre rule previously enforced by the Corps, members would scale back their projects in order to satisfy the “minimal effect” standard. But with the one-half acre rule, it is virtually impossible for NPPC members to do so because very few projects can fit within the one-half acre cap. Thus, the imagined environmental benefit to be achieved by the Corps’ inflexible one-half acre rule is unlikely to be realized.
J.A. 128. In their brief, the appellants characterize this paragraph as supporting the proposition that “[t]he restrictions in the [permits] and the delays in processing times mean that NPPC members cannot provide [their] important public services in a timely manner, increasing flood risk for the communities that NPPC members serve, posing a significant threat to people and property.” Appellants’ Br. at 13 (citing J.A. 128, ¶ 8).
NPPC’s theory of prudential standing, so far as we can tell, is rooted in the contention that the Corps’ failure to issue more lenient NWPs prevents NPPC from improving the environment. We need not conclude that NPPC’s theory fails to “square with the broad Congressional purpose in NEPA of assuring that environmental values would be adequately and pervasively considered in federal decision-making.” Realty Income Trust, 564 F.2d at 453. Even if we accept that it may be possible for NPPC’s members to suffer a procedural injury sufficient to bring them within NEPA’s zone-of-interest, nowhere does NPPC point to any evidence “supporting the proposition that there is a ‘substantial probability’ of ‘actual or imminent’ injury to its members arising from” the Corps’ failure to conduct an environmental analysis (i.e., a PEIS) of permits it did not issue but should have. Sierra Club, 292 F.3d at 902 (quoting & citing Am. Petroleum Inst. v. EPA, 216 F.3d 50, 63 (D.C.Cir.2000)). Tonsing’s declaration offers plenty of speculation: Paragraph eight speaks of its members’ “reduced” incentives in attempting to bring them projects within the parameters of the general *1289permits, of the “very few” projects that “can” fit the new conditions, of the “virtu-alt ] impossibility]” of meeting the conditions and of the “imagined environmental benefits” resulting from them. J.A. 128. But it offers nothing concrete from which we can conclude there is a “substantial probability” that NPPC’s members will suffer an injury sufficient under Sierra Club. See 292 F.3d at 898. The declaration does not mention a single specific project or activity that will not be undertaken because of the more restrictive NWPs the Corps did issue — as opposed to some other, presumably more lenient, permits favored by NPPC’s membership. See J.A. 125-29. Further casting doubt on the likelihood that, under its theory, NPPC will suffer any NEPA procedural harm is that, to the extent that NPPC members refuse to scale back their projects and try to secure an individual permit instead, the environmental impact of any such project would be evaluated as part of the individual permitting process. See 33 C.F.R. § 325.2(a)(4) (“A decision on a permit application will require either an environmental assessment or an environmental impact statement unless it is included within a categorical exclusion.”). Accordingly, because “a NEPA claim may not be raised by a party with no ... apparent environmental interest,” we are constrained to hold that the appellants cannot advance theirs. Town of Stratford, Conn. v. FAA, 285 F.3d 84, 88 (D.C.Cir.2002) (citation omitted). NEPA “cannot be used as a handy stick by a party with no interest in protecting against an environmental injury to attack a defendant.” Id.
Because we conclude that the appellants have not demonstrated a “substantial probability” that they fall within NEPA’s zone of interest, we affirm the dismissal of this claim. In view of this holding, we do not reach the NEPA ripeness issue. See N.J. Television Corp. v. FCC, 393 F.3d 219, 221 (D.C.Cir.2004) (“The priority for jurisdictional issues ... doesn’t control the sequence in which we resolve non-merits issues that prevent us from reaching the merits.” (citing Ruhrgas AG v. Marathon Oil Co., 526 U.S. 574, 584-85, 119 S.Ct. 1563, 143 L.Ed.2d 760 (1999); Grand Council of the Crees v. FERC, 198 F.3d 950, 954 (D.C.Cir.2000))); see also Galvan v. Fed. Prison Indus., Inc., 199 F.3d 461, 463 (D.C.Cir.1999) (“There is an array of nonmerits questions that we may decide in any order.”).
III.
For the foregoing reasons, the district court’s grant of summary judgment to the Corps on the appellants’ APA and RFA claims is reversed and remanded for further proceedings consistent with this opinion. The dismissal of the appellants’ NEPA claim is affirmed.
So ordered.
10.3 Exhaustion 10.3 Exhaustion
10.3.1 McCarthy v. Madigan, 503 U.S. 140 (1992) 10.3.1 McCarthy v. Madigan, 503 U.S. 140 (1992)
McCARTHY v. MADIGAN et al.
No. 90-6861.
Argued December 9, 1991
Decided March 4, 1992
*141Blackmun, J., delivered the opinion of the Court, in which White, Stevens, O’Connor, Kennedy, and Souter, JJ., joined. Rehnquist, C. J., filed an opinion concurring in the judgment, in which Scalia and Thomas, JJ., joined, post, p. 156.
Paul M. Smith argued the cause and filed briefs for petitioner.
Deputy Solicitor General Mahoney argued the cause for respondents. With her on the brief were Solicitor General Starr, Assistant Attorney General Mueller, Amy L. Wax, Victor D. Stone, and William D. Braun.
delivered the opinion of the Court.
The issue in this case is whether a federal prisoner must resort to the internal grievance procedure promulgated by the Federal Bureau of Prisons before he may initiate a suit, pursuant to the authority of Bivens v. Six Unknown Fed. Narcotics Agents, 403 U. S. 388 (1971), solely for money damages. The Court of Appeals for the Tenth Circuit ruled that exhaustion of the grievance procedure was required. 914 F. 2d 1411 (1990). We granted certiorari to resolve a conflict among the Courts of Appeals.1 499 U. S. 974 (1991).
*142I
While he was a prisoner in the federal penitentiary at Leavenworth, petitioner John J. McCarthy filed a pro se complaint in the United States District Court for the District of Kansas against four prison employees: the hospital administrator, the chief psychologist, another psychologist, and a physician. McCarthy alleged that respondents had violated his constitutional rights under the Eighth Amendment by their deliberate indifference to his needs and medical condition resulting from a back operation and a history of psychiatric problems. On the first page of his complaint, he wrote: “This Complaint seeks Money Damages Only.” App. 7.
The District Court dismissed the complaint on the ground that petitioner had failed to exhaust prison administrative remedies. Id., at 12. Under 28 CFR pt. 542 (1991), setting forth the general “Administrative Remedy Procedure for Inmates” at federal correctional institutions, a prisoner may “seek formal review of a complaint which relates to any aspect of his imprisonment.” § 542.10.2 When an inmate files a complaint or appeal, the responsible officials are directed to acknowledge the filing with a “signed receipt” which is returned to the inmate, to “[c]onduct an investigation,” and to “[rjespond to and sign all complaints or appeals.” §§ 542.11(a)(2) to (4). The general grievance regulations do not provide for any kind of hearing or for the granting of any particular type of relief.
*143To promote efficient dispute resolution, the procedure includes rapid filing and response timetables. An inmate first seeks informal resolution of his claim by consulting prison personnel. § 542.13(a). If this informal effort fails, the prisoner “may file a formal written complaint on the appropriate form, within fifteen (15) calendar days of the date on which the basis of the complaint occurred.” § 542.13(b). Should the warden fail to respond to the inmate’s satisfaction within 15 days, the inmate has 20 days to appeal to the Bureau’s Regional Director, who has 30 days to respond. If the inmate still remains unsatisfied, he has 30 days to make a final appeal to the Bureau’s general counsel, who has another 30 days to respond. §§542.14 and 542.15. If the inmate can demonstrate a “valid reason for delay,” he “shall be allowed” an extension of any of these time periods for filing. § 542.13(b).
Petitioner McCarthy filed with the District Court a motion for reconsideration under Federal Rule of Civil Procedure 60(b), arguing that he was not required to exhaust his administrative remedies, because he sought only money damages which, he claimed, the Bureau could not provide.3 1 Record, Exh. 7. The court denied the motion. App. 14.
The Court of Appeals, in affirming, observed that because Bivens actions are a creation of the judiciary, the courts may impose reasonable conditions upon their filing. 914 F. 2d, at 1412. The exhaustion rule, the court reasoned, “is not keyed to the type of relief sought, but to the need for prelim*144inary fact-finding” to determine “whether there is a possible Bivens cause of action.” Ibid. Accordingly, “‘[although the administrative apparatus could not award money damages . . . , administrative consideration of the possibility of corrective action and a record would have aided a court in measuring liability and determining the extent of the damages.’” Ibid., quoting Goar v. Civiletti, 688 F. 2d 27, 29 (CA6 1982) (emphasis in original). Exhaustion of the general grievance procedure was required notwithstanding the fact that McCarthy’s request was solely for money damages.
II
The doctrine of exhaustion of administrative remedies is one among related doctrines — including abstention, finality, and ripeness — that govern the timing of federal-court deci-sionmaking. Of “paramount importance” to any exhaustion inquiry is congressional intent. Patsy v. Board of Regents of Florida, 457 U. S. 496, 501 (1982). Where Congress specifically mandates, exhaustion is required. Coit Independence Joint Venture v. FSLIC, 489 U. S. 561, 579 (1989); Patsy, 457 U. S., at 502, n. 4. But where Congress has not clearly required exhaustion, sound judicial discretion governs. McGee v. United States, 402 U. S. 479, 483, n. 6 (1971). See also Patsy, 457 U. S., at 518 (White, J., concurring in part) (“[Ejxhaustion is ‘a rule of judicial administration,’. .. and unless Congress directs otherwise, rightfully subject to crafting by judges”). Nevertheless, even in this field of judicial discretion, appropriate deference to Congress’ power to prescribe the basic procedural scheme under which a claim may be heard in a federal court requires fashioning of exhaustion principles in a manner consistent with congressional intent and any applicable statutory scheme. Id., at 501-502, and n. 4.
A
This Court long has acknowledged the general rule that parties exhaust prescribed administrative remedies before *145seeking relief from the federal courts. See, e. g., Myers v. Bethlehem Shipbuilding Corp., 303 U. S. 41, 50-51, and n. 9 (1938) (discussing cases as far back as 1898). Exhaustion is required because it serves the twin purposes of protecting administrative agency authority and promoting judicial efficiency.
As to the first of these purposes, the exhaustion doctrine recognizes the notion, grounded in deference to Congress’ delegation of authority to coordinate branches of Government, that agencies, not the courts, ought to have primary responsibility for the programs that Congress has charged them to administer. Exhaustion concerns apply with particular force when the action under review involves exercise of the agency’s discretionary power or when the agency proceedings in question allow the agency to apply its special expertise. McKart v. United States, 395 U. S. 185, 194 (1969). See also Bowen v. City of New York, 476 U. S. 467, 484 (1986). The exhaustion doctrine also acknowledges the commonsense notion of dispute resolution that an agency ought to have an opportunity to correct its own mistakes with respect to the programs it administers before it is haled into federal court. Correlatively, exhaustion principles apply with special force when “frequent and deliberate flouting of administrative processes” could weaken an agency’s effectiveness by encouraging disregard of its procedures. McKart v. United States, 395 U. S., at 195.
As to the second of the purposes, exhaustion promotes judicial efficiency in at least two ways. When an agency has the opportunity to correct its own errors, a judicial controversy may well be mooted, or at least piecemeal appeals may be avoided. See, e. g., Parisi v. Davidson, 405 U. S. 34, 37 (1972); McKart v. United States, 395 U. S., at 195. And even where a controversy survives administrative review, exhaustion of the administrative procedure may produce a useful record for subsequent judicial consideration, especially in a complex or technical factual context. See, e. g., Weinberger *146v. Salfi, 422 U. S. 749, 765 (1975) (exhaustion may allow agency “to compile a record which is adequate for judicial review”).
B
Notwithstanding these substantial institutional interests, federal courts are vested with a “virtually unflagging obligation” to exercise the jurisdiction given them. Colorado River Water Conservation Dist. v. United States, 424 U. S. 800, 817-818 (1976). “We have no more right to decline the exercise of jurisdiction which is given, than to usurp that which is not given.” Cohens v. Virginia, 6 Wheat. 264, 404 (1821). Accordingly, this Court has declined to require exhaustion in some circumstances even where administrative and judicial interests would counsel otherwise. In determining whether exhaustion is required, federal courts must balance the interest of the individual in retaining prompt access to a federal judicial forum against countervailing institutional interests favoring exhaustion. “[A]dministrative remedies need not be pursued if the litigant’s interests in immediate judicial review outweigh the government’s interests in the efficiency or administrative autonomy that the exhaustion doctrine is designed to further.” West v. Bergland, 611 F. 2d 710, 715 (CA8 1979), cert. denied, 449 U. S. 821 (1980). Application of this balancing principle is “intensely practical,” Bowen v. City of New York, 476 U. S., at 484, citing Mathews v. Eldridge, 424 U. S. 319, 331, n. 11 (1976), because attention is directed to both the nature of the claim presented and the characteristics of the particular administrative procedure provided.
C
This Court’s precedents have recognized at least three broad sets of circumstances in which the interests of the individual weigh heavily against requiring administrative exhaustion. First, requiring resort to the administrative remedy may occasion undue prejudice to subsequent assertion *147of a court action. Such prejudice may result, for example, from an unreasonable or indefinite timeframe for administrative action. See Gibson v. Berryhill, 411 U. S. 564, 575, n. 14 (1973) (administrative remedy deemed inadequate “[m]ost often . . . because of delay by the agency”). See also Coit Independence Joint Venture v. FSLIC, 489 U. S., at 587 (“Because the Bank Board’s regulations do not place a reasonable time limit on FSLIC’s consideration of claims, Coit cannot be required to exhaust those procedures”); Walker v. Southern R. Co., 385 U. S. 196, 198 (1966) (possible delay of 10 years in administrative proceedings makes exhaustion unnecessary); Smith v. Illinois Bell Telephone Co., 270 U. S. 587, 591-592 (1926) (claimant “is not required indefinitely to await a decision of the rate-making tribunal before applying to a federal court for equitable relief”). Even where the administrative decisionmaking schedule is otherwise reasonable and definite, a particular plaintiff may suffer irreparable harm if unable to secure immediate judicial consideration of his claim. Bowen v. City of New York, 476 U. S., at 483 (disability-benefit claimants “would be irreparably injured were the exhaustion requirement now enforced against them”); Aircraft & Diesel Equipment Corp. v. Hirsch, 331 U. S. 752, 773 (1947) (“impending irreparable injury flowing from delay incident to following the prescribed procedure” may contribute to finding that exhaustion is not required). By the same token, exhaustion principles apply with less force when an individual’s failure to exhaust may preclude a defense to criminal liability. Moore v. East Cleveland, 431 U. S. 494, 497, n. 5 (1977) (plurality opinion); McKart v. United States, 395 U. S., at 197.
Second, an administrative remedy may be inadequate “because of some doubt as to whether the agency was empowered to grant effective relief.” Gibson v. Berryhill, 411 U. S., at 575, n. 14. For example, an agency, as a preliminary matter, may be unable to consider whether to grant relief because it lacks institutional competence to resolve the par*148ticular type of issue presented, such as the constitutionality of a statute. See, e. g., Moore v. East Cleveland, 431 U. S., at 497, n. 5; Mathews v. Diaz, 426 U. S. 67, 76 (1976). In a similar vein, exhaustion has not been required where the challenge is to the adequacy of the agency procedure itself, such that “ 'the question of the adequacy of the administrative remedy . . . [is] for all practical purposes identical with the merits of [the plaintiff’s] lawsuit.’ ” Barry v. Barchi, 443 U. S. 55, 63, n. 10 (1979) (quoting Gibson v. Berryhill, 411 U. S., at 575). Alternatively, an agency may be competent to adjudicate the issue presented, but still lack authority to grant the type of relief requested. McNeese v. Board of Ed. for Community Unit School Dist. 187, 373 U. S. 668, 675 (1963) (students seeking to integrate public school need not file complaint with school superintendent because the “Superintendent himself apparently has no power to order corrective action” except to request the Attorney General to bring suit); Montana National Bank of Billings v. Yellowstone County, 276 U. S. 499, 505 (1928) (taxpayer seeking refund not required to exhaust where “any such application [would have been] utterly futile since the county board of equalization was powerless to grant any appropriate relief” in face of prior controlling court decision).
Third, an administrative remedy may be inadequate where the administrative body is shown to be biased or has otherwise predetermined the issue before it. Gibson v. Berryhill, 411 U. S., at 575, n. 14; Houghton v. Shafer, 392 U. S. 639, 640 (1968) (in view of Attorney General’s submission that the challenged rules of the prison were “validly and correctly applied to petitioner,” requiring administrative review through a process culminating with the Attorney General “would be to demand a futile act”); Association of National Advertisers, Inc. v. FTC, 201 U. S. App. D. C. 165, 170-171, 627 F. 2d 1151, 1156-1157 (1979) (bias of Federal Trade Commission chairman), cert. denied, 447 U. S. 921 (1980). See also Patsy v. Florida International University, *149634 F. 2d 900, 912-913 (CA6 1981) (en banc) (administrative procedures must “not be used to harass or otherwise discourage those with legitimate claims”), rev’d on other grounds sub nom. Patsy v. Board of Regents of Florida, 457 U. S. 496 (1982).
Ill
In light of these general principles, we conclude that petitioner McCarthy need not have exhausted his constitutional claim for money damages. As a preliminary matter, we find that Congress has not meaningfully addressed the appropriateness of requiring exhaustion in this context. Although respondents’ interests are significant, we are left with a firm conviction that, given the type of claim McCarthy raises and the particular characteristics of the Bureau’s general grievance procedure, McCarthy’s individual interests outweigh countervailing institutional interests favoring exhaustion.
A
Turning first to congressional intent, we note that the general grievance procedure was neither enacted nor mandated by Congress. Respondents, however, urge that Congress, in effect, has acted to require exhaustion by delegating power to the Attorney General and the Bureau of Prisons to control and manage the federal prison system. See 18 U. S. C. §§ 4001(b) and 4042. Brief for Respondents 3, 16; Tr. of Oral Arg. 41-42. We think respondents confuse what Congress could be claimed to allow by implication with what Congress affirmatively has requested or required. By delegating authority, in the most general of terms, to the Bureau to administer the federal prison system, Congress cannot be said to have spoken to the particular issue whether prisoners in the custody of the Bureau should have direct access to the federal courts.
Respondents next argue that Congress, by enactment of §7 of the Civil Rights of Institutionalized Persons Act, 94 Stat. 352, 42 U. S. C. § 1997e, has articulated a policy favoring *150exhaustion of the prison grievance procedure prior to the filing of a constitutional claim against prison officials. Section 1997e imposes a limited exhaustion requirement for a claim brought by a state prisoner under Rev. Stat. § 1979, 42 U. S. C. § 1983, provided that the underlying state prison administrative remedy meets specified standards. See Patsy v. Board of Regents of Florida, 457 U. S., at 507-512. Section 1997e has no direct application in this case, because at issue here is a Bivens claim by a federal prisoner against federal prison officials. We find it significant that Congress, in enacting § 1997e, stopped short of imposing a parallel requirement in the federal prison context.
Section 1997e is not only inapplicable to Bivens claims, but — by its own terms — cuts against respondents’ claim that the particular procedure now at issue need be exhausted. First, unlike the rule of exhaustion proposed here, §1997e does not authorize dismissal of an action for failure to exhaust. Instead, it provides that the action is to be stayed for a maximum of 90 days. See § 1997e(a)(l). Second, § 1997e does not mechanically require exhaustion in every case where an acceptable state procedure is in place. Rather, it directs federal courts to abstain “if the court believes that such a [waiting] requirement would be appropriate and in the interests of justice.” § 1997e(a)(l). In other words, if an inmate fails to meet filing deadlines under an administrative scheme, a court has ample discretion to determine that exhaustion nonetheless should be forgone. Third, in contrast to the absence of any provision for the award of money damages under the Bureau’s general grievance procedure, the statute conditions exhaustion on the existence of “effective administrative remedies.”4 It is diffi*151cult to see why a stricter rule of exhaustion than Congress itself has required in the state prison context should apply in the federal prison context.
Respondents also argue that requiring exhaustion is appropriate because Bivens relief gives way when necessary to accommodate either the effective functioning of Government or an articulated congressional policy. Brief for Respondents 15. We have recognized that a Bivens remedy does not lie in two situations: (1) where Congress has provided an equally effective alternative remedy and declared it to be a substitute for recovery under the Constitution, and (2) where, in the absence of affirmative action by Congress, special factors counsel hesitation. Carlson v. Green, 446 U. S. 14, 18-19 (1980). As to the first exception, Congress did not create the remedial scheme at issue here and that scheme, in any case, as noted above, cannot be considered to be equally effective with respect to a claim for money damages. As to the second exception, respondents appear to confuse the presence of special factors with any factors counseling hesitation. In Carlson, the Court held that “special factors” do not free prison officials from Bivens liability, because prison officials do not enjoy an independent status in our constitutional scheme, nor are they likely to be unduly inhibited in the performance of their duties by the assertion of a Bivens claim. Carlson v. Green, 446 U. S., at 19.
Interpreting the “special factors” exception in Schweiker v. Chilicky, 487 U. S. 412 (1988), and in Bush v. Lucas, 462 *152U. S. 367 (1983), the Court found the Bivens remedy displaced because Congress had legislated an elaborate and comprehensive remedial scheme. Schweiker, 487 U. S., at 425; Bush, 462 U. S., at 388. “When the design of a Government program suggests that Congress has provided what it considers adequate remedial mechanisms for constitutional violations that may occur in the course of its administration, we have not created additional Bivens remedies.” Schweiker, 487 U. S., at 423. Here Congress has enacted nothing.
B
Because Congress has not required exhaustion of a federal prisoner’s Bivens claim, we turn to an evaluation of the individual and institutional interests at stake in this case. The general grievance procedure heavily burdens the individual interests of the petitioning inmate in two ways. First, the procedure imposes short, successive filing deadlines that create a high risk of forfeiture of a claim for failure to comply. Second, the administrative “remedy” does not authorize an award of monetary damages — the only relief requested by McCarthy in this action. The combination of these features means that the prisoner seeking only money damages has everything to lose and nothing to gain from being required to exhaust his claim under the internal grievance procedure.
The filing deadlines for the grievance procedure require an inmate, within 15 days of the precipitating incident, not only to attempt to resolve his grievance informally but also to file a formal written complaint with the prison, warden. 28 CFR §542.13 (1991). Then, he must successively hurdle 20-day and 30-day deadlines to advance to the end of the grievance process. §542.15. Other than the Bureau’s general and quite proper interest in having early notice of any claim, we have not been apprised of any urgency or exigency justifying this timetable. Cf. Yakus v. United States, 321 U. S. 414, 435 (1944) (“The sixty days’ period allowed for protest of the Administrator’s regulations cannot be said to be *153unreasonably short in view of the urgency and exigencies of wartime price regulation”). As a practical matter, the filing deadlines, of course, may pose little difficulty for the knowledgeable inmate accustomed to grievances and court actions. But they are a likely trap for the inexperienced and unwary inmate, ordinarily indigent and unrepresented by counsel, with a substantial claim.
Respondents argue that the deadlines are not jurisdictional and may be extended for any “valid” reason. See 28 CFR §§ 542.13(b) and 542.15 (1991). Yet the regulations do not elaborate upon what a “valid” reason is. Moreover, it appears that prison officials — perhaps the very officials subject to suit — are charged with determining what is a “valid” reason.
All in all, these deadlines require a good deal of an inmate at the peril of forfeiting his claim for money damages. The “first” of “the principles that necessarily frame our analysis of prisoners’ constitutional claims” is that “federal courts must take cognizance of the valid constitutional claims of prison inmates.” Turner v. Safley, 482 U. S. 78, 84 (1987). Because a prisoner ordinarily is divested of the privilege to vote, the right to file a court action might be said to be his remaining most “fundamental political right, because preservative of all rights.” Yick Wo v. Hopkins, 118 U. S. 356, 370 (1886). The rapid filing deadlines counsel strongly against exhaustion as a prerequisite to the filing of a federal-court action.5
*154As we have noted, the grievance procedure does not include any mention of the award of monetary relief. Respondents argue that this should not matter, because “in most cases there are other things that the inmate wants.” Tr. of Oral Arg. 30. This may be true in some instances. But we cannot presume, as a general matter, that when a litigant has deliberately forgone any claim for injunctive relief and has singled out discrete past wrongs, specifically requesting monetary compensation only, that he is likely interested in “other things.” The Bureau, in any case, is always free to offer an inmate administrative relief in return for withdrawal of his lawsuit. We conclude that the absence of any monetary remedy in the grievance procedure also weighs heavily against imposing an exhaustion requirement.
In the alternative, respondents argue that, despite the absence of any provision in the general grievance procedure for the award of money damages, such damages in fact are available for most prisoners asserting Bivens claims. As to Bivens claims that could have been brought under the Federal Tort Claims Act (FTCA),6 respondents contend that a grievance asking for money damages can be “converted” by prison officials to a FTCA claim for which prison officials are au*155thorized, under 28 CFR § 543.30 (1991), to award money damages. This “conversion” authority does not appear in the regulations having to do with the grievance procedure, which raises substantial doubt that an inmate would have sufficient notice as to how his claim would be treated. In any event, respondents have not pointed to anything in the record showing that prison officials have a practice of converting a claim filed under the general grievance procedure to a claim under the FTCA procedure. We agree with petitioner that it is implausible to think that they do. The availability of a money damages remedy is, at best, uncertain, and the uncertainty of the administrative agency’s authority to award relief counsels against requiring exhaustion. See Hillsborough v. Cromwell, 326 U. S. 620, 626 (1946); Union Pacific R. Co. v. Board of Comm’rs of Weld County, 247 U. S. 282, 287 (1918).
We do not find the interests of the Bureau of Prisons to weigh heavily in favor of exhaustion in view of the remedial scheme and particular claim presented here. To be sure, the Bureau has a substantial interest in encouraging internal resolution of grievances and in preventing the undermining of its authority by unnecessary resort by prisoners to the federal courts. But other institutional concerns relevant to exhaustion analysis appear to weigh in hardly at all. The Bureau’s alleged failure to render medical care implicates only tangentially its authority to carry out the control and management of the federal prisons. Furthermore, the Bureau does not bring to bear any special expertise on the type of issue presented for resolution here.
The interests of judicial economy do not stand to be advanced substantially by the general grievance procedure. No formal factfindings are made. The paperwork generated by the grievance process might assist a court somewhat in ascertaining the facts underlying a prisoner’s claim more quickly than if it has only a prisoner’s complaint to review. But the grievance procedure does not create a formal factual *156record of the type that can be relied on conclusively by a court for disposition of a prisoner’s claim on the pleadings or at summary judgment without the aid of affidavits.
C
In conclusion, we are struck by the absence of supporting material in the regulations, the record, or the briefs that the general grievance procedure here was crafted with any thought toward the principles of exhaustion of claims for money damages. The Attorney General’s professed concern for internal dispute resolution has not translated itself into a more effective grievance procedure that might encourage the filing of an administrative complaint as opposed to a court action. Congress, of course, is free to design or require an appropriate administrative procedure for a prisoner to exhaust his claim for money damages. Even without further action by Congress, we do not foreclose the possibility that the Bureau itself may adopt an appropriate administrative procedure consistent with congressional intent.
The judgment of the Court of Appeals is reversed.
It is so ordered.
with whom Justice Scalia and Justice Thomas join, concurring in the judgment.
I agree with the Court’s holding that a federal prisoner need not exhaust the procedures promulgated by the Federal Bureau of Prisons. My view, however, is based entirely on the fact that the grievance procedure at issue does not provide for any award of monetary damages. As a result, in cases such as this one where prisoners seek monetary relief, the Bureau’s administrative remedy furnishes no effective remedy at all, and it is therefore improper to impose an exhaustion requirement. See McNeese v. Board of Ed. for Community Unit School Dist. 187, 373 U. S. 668, 675 (1963); Montana National Bank of Billings v. Yellowstone County, 276 U. S. 499, 505 (1928).
*157Because I would base the decision on this ground, I do not join the Court’s extensive discussion of the general principles of exhaustion, nor do I agree with the implication that those general principles apply without modification in the context of a Bivens claim. In particular, I disagree with the Court’s reliance on the grievance procedure’s filing deadlines as a basis for excusing exhaustion. As the majority observes, ante, at 146-147, we have previously refused to require exhaustion of administrative remedies where the administrative process subjects plaintiffs to unreasonable delay or to an indefinite timeframe for decision. See Coit Independence Joint Venture v. FSLIC, 489 U. S. 561, 587 (1989); Gibson v. Berryhill, 411 U. S. 564, 575, n. 14 (1973); Walker v. Southern R. Co., 385 U. S. 196, 198 (1966); Smith v. Illinois Bell Telephone Co., 270 U. S. 587, 591-592 (1926). This principle rests on our belief that when a plaintiff might have to wait seemingly forever for an agency decision, agency procedures are “inadequate” and therefore need not be exhausted. Coit Independence Joint Venture v. FSLIC, supra, at 587.
But the Court makes strange use of this principle in holding that filing deadlines imposed by agency procedures may provide a basis for finding that those procedures need not be exhausted. Ante, at 152-153. Whereas before we have held that procedures without “reasonable time limit[s]” may be inadequate because they make a plaintiff wait too long, Coit Independence Joint Venture v. FSLIC, supra, at 587, today the majority concludes that strict filing deadlines might also contribute to a finding of inadequacy because they make a plaintiff move too quickly. But surely the second proposition does not follow from the first. In fact, short filing deadlines will almost always promote quick decision-making by an agency, the very result that we have advocated repeatedly in the cases cited above. So long as there is an escape clause, as there is here, and the time limit is within a *158zone of reasonableness, as I believe it is here, the length of the period should not be a factor in deciding the adequacy of the remedy.
10.3.2 Darby v. Cisneros, 509 U.S. 137 (1993) 10.3.2 Darby v. Cisneros, 509 U.S. 137 (1993)
DARBY et al. v. CISNEROS, SECRETARY OF HOUSING AND URBAN DEVELOPMENT, et al.
No. 91-2045.
Argued March 22, 1993
Decided June 21, 1993
*138Blackmun, J., delivered the opinion for a unanimous Court with respect to Parts I, II, and IV, and the opinion of the Court with respect to Part III, in which White, Stevens, O’Connor, Kennedy, and Souter, JJ., joined.
Steven D. Gordon argued the cause for petitioners. With him on the briefs was Michael H. Ditton.
James A. Feldman argued the cause for respondents. With him on the brief were Acting Solicitor General Bryson, Assistant Attorney General Gerson, Deputy Solicitor General Mahoney, and Anthony J. Steinmeyer.
delivered the opinion of the Court.* This case presents the question whether federal courts have the authority to require that a plaintiff exhaust available administrative remedies before seeking judicial review under the Administrative Procedure Act (APA), 5 U. S. C. § 701 et seq., where neither the statute nor agency rules specifically mandate exhaustion as a prerequisite to judicial re- ' view. At issue is the relationship between the judicially created doctrine of exhaustion of administrative remedies and the statutory requirements of § 10(c) of the APA.1
*139I
Petitioner R. Gordon Darby2 is a self-employed South Carolina real estate developer who specializes in the development and management of multifamily rental projects. In the early 1980’s, he began working with Lonnie Garvin, Jr., a mortgage banker, who had developed a plan to enable multifamily developers to obtain single-family mortgage insurance from respondent Department of Housing and Urban Development (HUD). Respondent Secretary of HUD (Secretary) is authorized to provide single-family mortgage insurance under § 203(b) of the National Housing Act, 48 Stat. 1249, as amended, 12 U. S. C. § 1709(b).3 Although HUD also provides mortgage insurance for multifamily projects under § 207 of the National Housing Act, 12 U. S. C. § 1713, the greater degree of oversight and control over such projects makes it less attractive for investors than the single-family mortgage insurance option.
The principal advantage of Garvin’s plan was that it promised to avoid HUD’s “Rule of Seven.” This rule prevented rental properties from receiving single-family mortgage insurance if the mortgagor already had financial interests in seven or more similar rental properties in the same project *140or subdivision. See 24 CFR § 203.42(a) (1992).4 Under Garvin’s plan, a person seeking financing would use straw purchasers as mortgage insurance applicants. Once the loans were closed, the straw purchasers would transfer title back to the development company. Because no single purchaser at the time of purchase would own more than seven rental properties within the same project, the Rule of Seven appeared not to be violated. HUD employees in South Carolina apparently assured Garvin that his plan was lawful and that he thereby would avoid the limitation of the Rule of Seven.
Darby obtained financing for three separate multiunit projects, and, through Garvin’s plan, Darby obtained single-family mortgage insurance from HUD. Although Darby successfully rented the units, a combination of low rents, falling interest rates, and a generally depressed rental market forced him into default in 1988. HUD became responsible for the payment of over $6.6 million in insurance claims.
HUD had become suspicious of Garvin’s financing plan as far back as 1983. In 1986, HUD initiated an audit but concluded that neither Darby nor Garvin had done anything wrong or misled HUD personnel. Nevertheless, in June 1989, HUD issued a limited denial of participation (LDP) that prohibited petitioners for one year from participating in any program in South Carolina administered by respondent Assistant Secretary of Housing.5 Two months later, the Assistant Secretary notified petitioners that HUD was also proposing to debar them from further participation in all HUD *141procurement contracts and in any nonprocurement transaction with any federal agency. See 24 CFR §24.200 (1992).
Petitioners’ appeals of the LDP and of the proposed debarment were consolidated, and an Administrative Law Judge (ALJ) conducted a hearing on the consolidated appeals in December 1989. The judge issued an “Initial Decision and Order” in April 1990, finding that'the financing method used by petitioners was “a sham which improperly circumvented the Rule of Seven.” App. to Pet. for Cert. 69a. The ALJ concluded, however, that most of the relevant facts had been disclosed to local HUD employees, that petitioners lacked criminal intent, and that Darby himself “genuinely cooperated with HUD to try [to] work out his financial dilemma and avoid foreclosure.” Id., at 88a. In light of these mitigating factors, the ALJ concluded that an indefinite debarment would be punitive and that it would serve no legitimate purpose; 6 good cause existed, however, to debar petitioners for a period of 18 months.7 Id., at 90a.
Under HUD regulations,
“The hearing officer’s determination shall be final unless, pursuant to 24 CFR part 26, the Secretary or the Secretary’s designee, within 30 days of receipt of a request decides as a matter of discretion to review the finding of the hearing officer. The 30 day period for deciding whether to review a determination may be extended upon written notice of such extension by the Secretary or his designee. Any party may request such a review in writing within 15 days of receipt of the hearing officer’s determination.” 24 CFR § 24.314(c) (1992).
*142Neither petitioners nor respondents sought further administrative review of the ALJ’s “Initial Decision and Order.”
On May 31,1990, petitioners filed suit in the United States District Court for the District of South Carolina. They sought an injunction and a declaration that the administrative sanctions were imposed for purposes of punishment, in violation of HUD’s own debarment regulations, and therefore were “not in accordance with law” within the meaning of § 10(e)(B)(l) of the APA, 5 U. S. C. § 706(2)(A).
Respondents moved to dismiss the complaint on the ground that petitioners, by forgoing the option to seek review by the Secretary, had failed to exhaust administrative remedies. The District Court denied respondents’ motion to dismiss, reasoning that the administrative remedy was inadequate and that resort to that remedy would have been futile. App. to Pet. for Cert. 29a. In a subsequent opinion, the District Court granted petitioners’ motion for summary judgment, concluding that the “imposition of debarment in this case encroached too heavily on the punitive side of the line, and for those reasons was an abuse of discretion and not in accordance with the law.” Id., at 19a.
The Court of Appeals for the Fourth Circuit reversed. Darby v. Kemp, 957 F. 2d 145 (1992). It recognized that neither the National Housing Act nor HUD regulations expressly mandate exhaustion of administrative remedies prior to filing suit. The court concluded, however, that the District Court had erred in denying respondents’ motion to dismiss, because there was no evidence to suggest that further review would have been futile or that the Secretary would have abused his discretion by indefinitely extending the time limitations for review.
The court denied petitioners’ petition for rehearing with suggestion for rehearing en banc. See App. to Pet. for Cert. 93a. In order to resolve the tension between this and the APA, as well as to settle a perceived conflict among the *143Courts of Appeals,8 we granted certiorari. 506 U. S. 952 (1992).
II
Section 10(c) of the APA bears the caption “Actions reviewable.” It provides in its first two sentences that judicial review is available for “final agency action for which there is no other adequate remedy in a court,” and that “preliminary, procedural, or intermediate agency action ... is subject to review on the review of the final agency action.” The last sentence of § 10(c) reads:
“Except as otherwise expressly required by statute, agency action otherwise final is final for the purposes of this section whether or not there has been presented or determined an application for a declaratory order, for any form of reconsideration [see n. 1, supra], or, unless the agency otherwise requires by rule and provides that the action meanwhile is inoperative, for an appeal to superior agency authority.” 80 Stat. 392-393, 5 U. S. C. §704.
Petitioners argue that this provision means that a litigant seeking judicial review of a final agency action under the APA need not exhaust available administrative remedies unless such exhaustion is expressly required by statute or agency rule. According to petitioners, since § 10(c) contains an explicit exhaustion provision, federal courts are not free to require further exhaustion as a matter of judicial discretion.
*144Respondents contend that § 10(c) is concerned solely with timing, that is, when agency actions become “final,” and that Congress had no intention to interfere with the courts' ability to impose conditions on the timing of their exercise of jurisdiction to review final agency actions. Respondents concede that petitioners’ claim is “final” under § 10(c), for neither the National Housing Act nor applicable HUD regulations require that a litigant pursue further administrative appeals prior to seeking judicial review. However, even though nothing in § 10(c) precludes judicial review of petitioners’ claim, respondents argue that federal courts remain free under the APA to impose appropriate exhaustion requirements.9
We have recognized that the judicial doctrine of exhaustion of administrative remedies is conceptually distinct from the doctrine of finality:
“[T]he finality requirement is concerned with whether the initial decisionmaker has arrived at a definitive position on the issue that inflicts an actual, concrete injury; the exhaustion requirement generally refers to administrative and judicial procedures by which an injured party may seek review of an adverse decision and obtain a remedy if the decision is found to be unlawful or otherwise inappropriate.” Williamson County Regional Planning Comm’n v. Hamilton Bank of Johnson City, 473 U. S. 172, 193 (1985).
Whether courts are free to impose an exhaustion requirement as a matter of judicial discretion depends, at least in part, on whether Congress has provided otherwise, for “[o]f *145‘paramount importance’ to any exhaustion inquiry is congressional intent,” McCarthy v. Madigan, 503 U. S. 140, 144 (1992), quoting Patsy v. Board of Regents of Florida, 457 U. S. 496, 501 (1982). We therefore must consider whether § 10(c), by providing the conditions under which agency action becomes “final for the purposes of” judicial review, limits the authority of courts to impose additional exhaustion requirements as a prerequisite to judicial review.
It perhaps is surprising that it has taken over 45 years since the passage of the APA for this Court definitively to address this question. Professor Davis noted in 1958 that § 10(c) had been almost completely ignored in judicial opinions, see 3 K. Davis, Administrative Law Treatise §20.08, p. 101 (1958); he reiterated that observation 25 years later, noting that the “provision is relevant in hundreds of eases and is customarily overlooked.” 4 K. Davis, Administrative Law Treatise §26.12, pp. 468-469 (2d ed. 1983). Only a handful of opinions in the Courts of Appeals have considered the effect of § 10(c) on the general exhaustion doctrine. See n. 8, supra.
This Court has had occasion, however, to consider § 10(c) in other contexts. For example, in ICC v. Locomotive Engineers, 482 U. S. 270 (1987), we recognized that the plain language of § 10(c), which provides that an agency action is final “whether or not there has been presented or determined an application” for any form of reconsideration, could be read to suggest that the agency action is final regardless whether a motion for reconsideration has been filed. We noted, however, that § 10(c) “has long been construed by this and other courts merely to relieve parties from the requirement of petitioning for rehearing before seeking judicial review (unless, of course, specifically required to do so by statute — see, e. g., 15 U. S. C. §§ 717r, 3416(a)), but not to prevent petitions for reconsideration that are actually filed from rendering the orders under reconsideration nonfinal” (emphasis in original). Id., at 284-285.
*146In Bowen v. Massachusetts, 487 U. S. 879 (1988), we were concerned with whether relief available in the Claims Court was an “adequate remedy in a court” so as to preclude review in Federal District Court of a final agency action under the first sentence of § 10(c). We concluded that “although the primary thrust of [§ 10(c)] was to codify the exhaustion requirement,” id., at 903, Congress intended by that provision simply to avoid duplicating previously established special statutory procedures for review of agency actions.
While some dicta in these cases might be claimed to lend support to respondents’ interpretation of § 10(c), the text of the APA leaves little doubt that petitioners are correct. Under § 10(a) of the APA, “[a] person suffering legal wrong because of agency action, or adversely affected or aggrieved by agency action within the meaning of a relevant statute, is entitled to judicial review thereof.” 5 U. S. C. § 702 (emphasis added). Although § 10(a) provides the general right to judicial review of agency actions under the APA, § 10(c) establishes when such review is available. When an aggrieved party has exhausted all administrative remedies expressly prescribed by statute or agency rule, the agency action is “final for the purposes of this section” and therefore “subject to judicial review” under the first sentence. While federal courts may be free to apply, where appropriate, other prudential doctrines of judicial administration to limit the scope and timing of judicial review, § 10(c), by its very terms, has limited the availability of the doctrine of exhaustion of administrative remedies to that which the statute or rule clearly mandates.
The last sentence of § 10(c) refers explicitly to “any form of reconsideration” and “an appeal to superior agency authority.” Congress clearly was concerned with making the exhaustion requirement unambiguous so that aggrieved parties would know precisely what administrative steps were required before judicial review would be available. If courts were able to impose additional exhaustion requirements be*147yond those provided by Congress or the agency, the last sentence of § 10(c) would make no sense. To adopt respondents’ reading would transform § 10(c) from a provision designed to “‘remove obstacles to judicial review of agency action,’” Bowen v. Massachusetts, 487 U. S., at 904, quoting Shaughnessy v. Pedreiro, 349 U. S. 48, 51 (1955), into a trap for unwary litigants. Section 10(c) explicitly requires exhaustion of all intra-agency appeals mandated either by statute or by agency rule; it would be inconsistent with the plain language of § 10(c) for courts to require litigants to exhaust optional appeals as well.
Ill
Recourse to the legislative history of § 10(c) is unnecessary in light of the plain meaning of the statutory text. Nevertheless, we consider that history briefly because both sides have spent much of their time arguing about its implications. In its report on the APA, the Senate Judiciary Committee explained that the last sentence of § 10(c) was “designed to implement the provisions of section 8(a).” Section 8(a), now codified, as amended, as 5 U. S. C. § 557(b), provides, unless the agency requires otherwise, that an initial decision made by a hearing officer “becomes the decision of the agency without further proceedings unless there is an appeal to, or review on motion of, the agency within time provided by rule.” The Judiciary Committee explained:
“[A]n agency may permit an examiner to make the initial decision in a case, which becomes the agency’s decision in the absence of an appeal to or review by the agency. If there is such review or appeal, the examiner’s initial decision becomes inoperative until the agency determines the matter. For that reason this subsection [§ 10(c)] permits an agency also to require by rule that, if any party is not satisfied with the initial decision of a subordinate hearing officer, the party must first appeal to the agency (the decision meanwhile being inopera*148tive) before resorting to the courts. In no case may appeal to ‘superior agency authority’ be required by rule unless the administrative decision meanwhile is inoperative, because otherwise the effect of such a requirement would be to subject the party to the agency action and to repetitious administrative process without recourse. There is a fundamental inconsistency in requiring a person to continue ‘exhausting’ administrative processes after administrative action has become, and while it remains, effective.” S. Rep. No. 752, 79th Cong., 1st Sess., 27 (1945); Administrative Procedure Act: Legislative History 1944-1946, S. Doc. No. 248, 79th Cong., 2d Sess., 213 (1946) (hereinafter Leg. Hist.).
In a statement appended to a letter dated October 19, 1945, to the Judiciary Committee, Attorney General Tom C. Clark set forth his understanding of the effect of § 10(c):
“This subsection states (subject to the provisions of section 10(a)) the acts which are reviewable under section 10. It is intended to state existing law. The last sentence makes it clear that the doctrine of exhaustion of administrative remedies with respect to finality of agency action is intended to be applied only (1) where expressly required by statute ... or (2) where the agency’s rules require that decisions by subordinate officers must be appealed to superior agency authority before the decision may be regarded as final for purposes of judicial review.” Id., at 44, Leg. Hist. 230.10
*149Respondents place great weight on the Attorney General’s statement that § 10(c) “is intended to state existing law.” That law, according to respondents, “plainly permitted federal courts to require exhaustion of adequate administrative remedies.” Brief for Respondents 19-20. We cannot agree with this categorical pronouncement. With respect to the exhaustion of motions for administrative reconsideration or rehearing, the trend in pre-APA cases was in the opposite direction. In Vandalia R. Co. v. Public Serv. Comm’n of Ind., 242 U. S. 255 (1916), for example, this Court invoked the “general rule” that “one aggrieved by the rulings of such an administrative tribunal may not complain that the Constitution of the United States has been violated if he has not availed himself of the remedies prescribed by the state law for a rectification of such rulings.” Id., at 261. The state law provided only that the Railroad Commission had the authority to grant a rehearing; it did not require that a rehearing be sought. Nevertheless, “since the record shows that plaintiff in error and its associates were accorded a rehearing upon the very question of modification, but abandoned it, nothing more need be said upon that point.” Ibid.
Seven years later, in Prendergast v. New York Telephone Co., 262 U. S. 43, 48 (1923), without even mentioning the Vandalia case, the Court stated:
“It was not necessary that the Company should apply to the Commission for a rehearing before resorting to the court. While under the Public Service Commission Law any person interested in an order of the Commission has the right to apply for a rehearing, the Commission is not required to grant such rehearing unless in its judgment sufficient reasons therefor appear .... As the law does not require an application for a rehearing *150to be made and its granting is entirely within the discretion of the Commission, we see no reason for requiring it to be made as a condition precedent to the bringing of a suit to enjoin the enforcement of the order.”
Accord, Banton v. Belt Line R. Corp., 268 U. S. 413, 416-417 (1925) (“No application to the commission for relief was required by the state law. None was necessary as a condition precedent to the suit”).
Shortly before Congress adopted the APA, the Court, in Levers v. Anderson, 326 U. S. 219 (1945), held that where a federal statute provides that a district supervisor of the Alcohol Tax Unit of the Bureau of Internal Revenue “may hear the application” for a rehearing of an order denying certain liquor permits, such an application was not a prerequisite to judicial review. Nothing “persuades us that the ‘may’ means must, or that the Supervisors were required to hear oral argument.” Id., at 223 (emphasis added). Despite the fact that the regulations permitted a stay pending the motion for reconsideration, the Court concluded that “the motion is in its effect so much like the normal, formal type of motion for rehearing that we cannot read into the Act an intention to make it a prerequisite to the judicial review specifically provided by Congress.” Id., at 224.
Respondents in effect concede that the trend in the law prior to the enactment of the APA was to require exhaustion of motions for administrative reconsideration or rehearing only when explicitly mandated by statute. Respondents argue, however, that the law governing the exhaustion of administrative appeals prior to the APA was significantly different from § 10(c) as petitioners would have us interpret it. Brief for Respondents 23. Respondents rely on United States v. Sing Tuck, 194 U. S. 161 (1904), in which the Court considered whether, under the relevant statute, an aggrieved party had to appeal an adverse decision by the Inspector of Immigration to the Secretary of Commerce and Labor before *151judicial review would be available.11 It recognized that the relevant statute “points out a mode of procedure which must be followed before there can be a resort to the courts,” id., at 167, and that a party must go through “the preliminary sifting process provided by the statutes,” id., at 170. Accord, Chicago, M., St. P. & P. R. Co. v. Risty, 276 U. S. 567, 574-575 (1928).12
Nothing in this pre-APA history, however, supports respondents’ argument that initial decisions that were “final” for purposes of judicial review were nonetheless unreviewable unless and until an administrative appeal was taken. The pre-APA cases concerning judicial review of federal agency action stand for the simple proposition that, until an administrative appeal was taken, the agency action was unreviewable because it was not yet “final.” This is hardly surprising, given the fact that few, if any, administrative agencies authorized hearing officers to make final agency decisions prior to the enactment of the APA. See Federal Administrative Law Developments — 1971, 1972 Duke L. J. 115, 295, n. 22 (“[Pjrior to the passage of the APA, the existing agencies ordinarily lacked the authority to make binding de*152terminations at a level below that of the agency board or commission, so that section 10(c) would be expected to affect the exhaustion doctrine in only a very limited number of instances”).
The purpose of § 10(c) was to permit agencies to require an appeal to “superior agency authority” before an examiner’s initial decision became final. This was necessary because, under § 8(a), initial decisions could become final agency decisions in the absence of an agency appeal. See 5 U. S. C. § 557(b). Agencies may avoid the finality of an initial decision, first, by adopting a rule that an agency appeal be taken before judicial review is available, and, second, by providing that the initial decision would be “inoperative” pending appeal. Otherwise, the initial decision becomes final and the aggrieved party is entitled to judicial review.
Respondents also purport to find support for their view in the text and legislative history of the 1976 amendments of the APA. After eliminating the defense of sovereign immunity in APA cases, Congress provided: “Nothing herein . . . affects other limitations on judicial review or the power or duty of the court to dismiss any action or deny relief on any other appropriate legal or equitable ground,” Pub. L. 94-574, § 1, 90 Stat. 2721 (codified as 5 U. S. C. § 702). According to respondents, Congress intended by this proviso to ensure that the judicial doctrine of exhaustion of administrative remedies would continue to apply under the APA to permit federal courts to refuse to review agency actions that were nonetheless final under § 10(c). See S. Rep. No. 94-996, p. 11 (1976) (among the limitations on judicial review that remained unaffected by the 1976 amendments was the “failure to exhaust administrative remedies”).13
*153Putting to one side the obvious problems with relying on postenactment legislative history, see, e. g., United States v. Texas, 507 U. S. 529, 535, n. 4 (1993); Pension Benefit Guaranty Corporation v. LTV Corp., 496 U. S. 633, 650 (1990), the proviso was added in 1976 simply to make clear that “[a]ll other than the law of sovereign immunity remain unchanged,” S. Rep. No. 94-996, at 11. The elimination of the defense of sovereign immunity did not affect any other limitation on judicial review that would otherwise apply under the APA. As already discussed, the exhaustion doctrine continues to exist under the APA to the extent that it is required by statute or by agency rule as a prerequisite to judicial review. Therefore, there is nothing inconsistent between the 1976 amendments to the APA and our reading of § 10(c).
IV
We noted just last Term in a non-APA case that
“appropriate deference to Congress’ power to prescribe the basic procedural scheme under which a claim may be heard in a federal court requires fashioning of exhaustion principles in a manner consistent with congressional intent and any applicable statutory scheme.” McCarthy v. Madigan, 503 U. S., at 144.
Appropriate deference in this case requires the recognition that, with respect to actions brought under the APA, Congress effectively codified the doctrine of exhaustion of administrative remedies in § 10(c). Of course, the exhaustion *154doctrine continues to apply as a matter of judicial discretion in cases not governed by the APA. But where the APA applies, an appeal to “superior agency authority” is a prerequisite to judicial review only when expressly required by statute or when an agency rule requires appeal before review and the administrative action is made inoperative pending that review. Courts are not free to impose an exhaustion requirement as a rule of judicial administration where the agency action has already become “final” under § 10(c).
The judgment of the Court of Appeals is reversed, and the case is remanded for further proceedings consistent with this opinion.
It is so ordered.