Ciba-Geigy Corp. v. U.S. Environmental Protection Agency

Opinion for the Court filed by Circuit Judge STARR.

Dissenting Opinion filed by Circuit Judge SILBERMAN.

STARR, Circuit Judge:

Ciba-Geigy Corporation appeals from an order of the District Court dismissing its complaint on grounds of ripeness. The gravamen of Ciba-Geigy’s complaint is that the Environmental Protection Agency required it to change the labeling of its registered pesticide, simazine, without affording the Company an adjudicatory hearing required by section 6(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA or Act), 7 U.S.C. § 136d(b) (1982). For the reasons that follow, we conclude that Ciba-Geigy’s claim is ripe for review and remand it to the District Court for adjudication.

I

Under FIFRA, all pesticides sold, distributed or received in the United States must be registered by EPA. 7 U.S.C. § 136a(a). An applicant for registration is required to file, among other things, a copy of the labeling of the pesticide and data supporting the product’s safety and efficacy. Id. § 136a(c)(1)-(2) (1982 & Supp. II 1984). EPA will not approve a registration unless it determines that the proposed labeling satisfies FIFRA’s requirements and that the pesticide “when used in accordance with widespread and commonly recognized practice ... will not generally cause unreasonable adverse effects on the environment.” Id. § 136a(c)(5). When it appears that a registered pesticide no longer conforms to these standards, EPA may seek to cancel the product’s registration or change its classification. Id. § 136d(b). Section 6(b) of the Act, however, expressly grants registrants the right to a formal, public hearing and the views of a Committee of the National Academy of Sciences and a Scientific Advisory Panel before the proposed cancellation or classification change takes effect. Id. § 136d(b); see also id. §§ 136d(d), 136w(d) (1982 & Supp. II 1984).

A separate section of FIFRA renders unlawful the sale, distribution or receipt of “misbranded” pesticides. Id. § 136j(a)(1)(E). The Act provides twelve definitions of a misbranded pesticide, three of which are pertinent here:

the label does not contain a warning or caution statement which may be necessary and if complied with ... is adequate to protect health and the environment; or

the labeling does not contain a statement of the use classification under which the product is registered.

Id. § 136(q)(1)(F), (1)(G), (2)(B). Misbrand-ed pesticides are subject to seizure, id. § 136k(b)(1)(A), and persons who unlawfully use misbranded pesticides are subject to a “ ‘stop sale, use, or removal order,’ ” id. § 136k(a), and civil and criminal penalties, id. § 136l (a), (b).

Ciba-Geigy manufactures and sells chemical products, including the pesticide sima-zine. Simazine has been registered by EPA since 1957 for use on various agricultural, industrial and aquatic sites to control weeds and algae.

During the 1970’s, EPA pursuant to Congressional mandate began the lengthy process of reregistering all pesticides. See id. § 136a(g). In April 1984, EPA promulgated a “Registration Standard” for sima-zine, setting forth the agency’s evaluation of available data and its position regarding the measures necessary to bring simazine into compliance with FIFRA’s registration criteria. Joint Appendix (J.A.) at 45-59. In the Registration Standard, EPA expressed concern about simazine contamination of groundwater. On the basis of that potential hazard, EPA directed additional studies to assess fully the environmental effects of simazine prior to its ultimate-reregistration. In addition, the Registration Standard imposed a deadline of December 31,1984, for changing simazine’s classification from general use to “restricted use,” for changing the product’s label to indicate the use restriction, and for including a warning against use of simazine in areas with specified soil and groundwater conditions.

EPA sent a follow-up notice in July to all twenty simazine registrants reiterating the agency’s concern about groundwater contamination, the need for interim restrictions on simazine’s use, and the need for modification of the product’s label. This notice further stated that “[t]he Agency intends to institute cancellation proceedings to cancel under FIFRA section 6(b)(1) all end-use products containing simazine ... not bearing the required labeling changes as specified above by December 31, 1984.” J.A. at 61.

On December 21, 1984, EPA advised si-mazine registrants by mailgram of a revised labeling statement concerning the groundwater hazard and of a new deadline, January 30, 1985, for the labeling change. The opening paragraph of the mailgram concluded with the following warning: “Affected stocks shipped after that date without the required changes will be considered misbranded.” J.A. at 62. The mailgram also advised registrants that “[i]f revised labels are not submitted, it will be necessary to take steps to cancel the registration(s).” J.A. at 63. After the July and December notices were dispatched by EPA, 17 of the 20 simazine registrants either complied with the new labeling requirements or voluntarily cancelled their registration.

In January 1985, Ciba-Geigy’s counsel wrote the Director of EPA’s Office of Pesticide Programs setting forth Ciba-Geigy’s position “that the proposed label changes are unwarranted and therefore [the Company] does not intend voluntarily to implement the requested changes.” J.A. at 64. The stated purpose of the letter was to obtain clarification from EPA concerning the procedure by which the agency intended to enforce the label changes. In particular, Ciba-Geigy expressed its understanding that EPA was obliged to follow the registration cancellation process set forth in section 6(b) of FIFRA before it could bring a misbranding action against a pesticide registrant for failure to comply with proposed labeling changes. Ciba-Gei-gy observed that, despite this statutorily mandated procedure, EPA’s December 21 mailgram suggested that EPA could bring an enforcement action for misbranding without first cancelling Ciba-Geigy’s existing registration.

Shortly after Ciba-Geigy submitted a second request to the agency for clarification in early March 1985, EPA’s Director of Pesticide Programs responded by letter advising that “[i]t is the Agency’s position that any [simazine] products not bearing the required statement of restricted use classification or groundwater, advisory statement and sold, distributed, shipped, or released for shipment by Ciba-Geigy Corporation after January 30,1985 are misbrand-ed under §§ 2(q)(1)(F), 2(q)(1)(G), and/or 2(q)(2)(B) of FIFRA” and subject to “appropriate enforcement action concerning mis-branded products under FIFRA.” J.A. at 69-70. In the letter, the Director expressly warned the registrant that “the Agency does not agree with your interpretation” of FIFRA, namely that the section 6(b) notice and hearing procedures for registration cancellation are the sole means by which EPA may require a registrant to make labeling changes. Id. at 69.

Ciba-Geigy thereupon filed suit in federal district court seeking declaratory and in-junctive relief against EPA for imposing labeling changes and use restrictions on a registered product without affording the procedures mandated by section 6(b) of FI-FRA. The complaint briefly chronicled the series of mailings through which EPA, in effect, denied Ciba-Geigy a cancellation hearing, including the April 1984 Registration Standard, the July and December 1984 notices and the March 1985 letter. The Company further alleged that since receipt of EPA’s December 21 mailgram it had halted shipment of all simazine products which do not satisfy EPA’s new labeling requirements; it also asserted that compliance with those requirements would occasion a 50 percent loss in sales because users would instead turn to unrestricted alternative herbicides.

Two days after Ciba-Geigy filed suit, EPA sent another letter to the Company. J.A. at 71-72. This letter reaffirmed EPA’s position that under FIFRA the agency enjoys authority to require all simazine registrants to provide the groundwater contamination warning on the label by threatening immediate EPA enforcement action for misbranding under sections 2(q)(1)(F) and 2(q)(1)(G) of the Act.

On cross-motions for summary judgment and EPA’s motion to dismiss for lack of ripeness, the District Court dismissed the complaint on the ground that EPA “has neither issued a final order directed to the plaintiff Ciba-Geigy nor taken any other final action which is reviewable by the Court.” 607 F.Supp. 1467, 1468 (D.D.C.1985). Although recognizing that the “complaint stems from a series of mailings,” the District Court focused exclusively on the December mailgram and determined that under the standards articulated by the Supreme Court in FTC v. Standard Oil Co. (SOCAL), 449 U.S. 232, 101 S.Ct. 488, 66 L.Ed.2d 416 (1980), “the mailgram may not be deemed final agency action and is itself devoid of legal effect.” 607 F.Supp. at 1468-69.

From this adverse decision, Ciba-Geigy filed the present appeal. We are informed that EPA has taken no action to date to cancel Ciba-Geigy’s simazine registration on the basis of the absence of a groundwater advisory statement.

II

The sole question before us is whether Ciba-Geigy’s complaint presents a controversy ripe for judicial review. Ripeness doctrine serves two important functions as a limitation on judicial review of agency action. See Abbott Laboratories v. Gardner, 387 U.S. 136, 148, 87 S.Ct. 1507, 1515, 18 L.Ed.2d 681 (1967). First, it prevents judicial involvement in abstract or remote controversies that are likely never to require resolution or likely to evolve substantially before resolution becomes necessary. Thus, the ripeness principle conserves judicial resources for cases in which those resources are truly needed and may be efficiently employed. Second, the doctrine enables agencies to deliberate and craft pok-cy free of judicial interference until administrative action has a direct and immediate impact. Judicial intervention into agency decisionmaking at an earlier stage “denies the agency an opportunity to correct its own mistakes and to apply its expertise.” SOCAL, 449 U.S. at 242, 101 S.Ct. at 494.

The framework for analyzing the ripeness of pre-enforcement agency action is well established. Under the two-part test set forth by the Supreme Court in Abbott Laboratories, we must consider “both the fitness of the issue for judicial decision and the hardship to the parties of withholding court consideration.” 387 U.S. at 149, 87 S.Ct. at 1515. Fitness and hardship function as independent but related variables, the former as a measure of the interests of the court and agency in postponing review and the latter as a measure of the challenging party’s countervailing interest in securing immediate judicial review. The judiciary’s ultimate determination of ripeness in a specific setting depends on a pragmatic balancing of those two variables and the underlying interests which they represent. Continental Air Lines, Inc. v. CAB, 522 F.2d 107, 125 (D.C.Cir.1974) (en banc); see also 4 K. Davis, Administrative Law Treatise § 25:15, at 405 (2d ed. 1983).

Under this “practical common sense” approach, the ripeness inquiry does not turn on nice legal distinctions. Continental Air Lines, 522 F.2d at 124. Courts confronted with close questions of ripeness are appropriately guided by the presumption of reviewability, especially when the affected person is confronted with the dilemma of choosing between disadvantageous compliance or risking imposition of serious penalties. Id. at 128; see also 4 K. Davis, supra, § 25:6-7.

The inquiry as to fitness for review encompasses several factors, including whether the issue presented is a purely legal one, whether consideration of that issue would benefit from a more concrete setting, and whether the agency’s action is sufficiently final. See, e.g., Abbott Laboratories, 387 U.S. at 149-52, 87 S.Ct. at 1515-17; Gardner v. Toilet Goods Association, 387 U.S. 167, 171, 87 S.Ct. 1526, 1528, 18 L.Ed.2d 704 (1967). It is beyond peradventure that the first two of these factors are satisfied here. The principal issue presented to the District Court was one of statutory interpretation: whether EPA properly construed FIFRA to allow it to impose labeling changes on registered pesticides without following the cancellation process prescribed in section 6(b). The parties agree that this is a purely legal issue. Both sides moved for summary judgment in the District Court on this point, and EPA has not sought to justify its interpretation of the Act on the basis of the specific facts of the case. As in Abbott Laboratories itself, “both sides have approached this case as one purely of congressional intent,” 387 U.S. at 149, 87 S.Ct. at 1515; moreover, we have no reason to believe that our consideration of the issue would be facilitated by further factual developments.

We next turn to the question whether the agency action is sufficiently final that either the judiciary or the executive has little or no interest in postponing review. The term “agency action” encompasses an agency’s interpretation of law. National Automatic Laundry & Cleaning Council v. Shultz (NALCC), 443 F.2d 689, 698 (D.C.Cir.1971). It is therefore the finality of that interpretative position which is relevant for purposes of determining the ripeness of the statutory question.

The District Court, however, embarked on a different analysis. The District Court concluded that EPA had taken no final misbranding action against Ciba-Geigy and that the absence of any final action in this respect rendered the controversy unripe. But as we have seen, Ciba-Geigy’s complaint did not challenge the merits of EPA’s labeling requirements or the sufficiency of EPA’s case for misbranding. It raised instead a pure legal question as to what procedures EPA was obliged to follow before requiring a labeling change. That narrow legal question is entirely independent of and separable from the largely factual question whether simazine poses a substantial danger of groundwater contamination. Cf. SOCAL, 449 U.S. at 241, 246, 101 S.Ct. at 493, 496 (agency’s issuance of complaint initiating enforcement action held not separable from agency’s ultimate enforcement decision when determining whether agency action is sufficiently final to permit judicial review). The pertinent inquiry before the District Court was whether EPA has taken final action with respect to Ciba-Geigy’s asserted statutory right to a cancellation hearing.

As the Supreme Court has instructed, we are to apply the finality requirement in a “flexible” and “pragmatic” way. Abbott Laboratories, 387 U.S. at 149-50, 87 S.Ct. at 1515-16. In particular, we look primarily to whether the agency’s position is “definitive” and whether it has a “ ‘direct and immediate ... effect on the day-to-day business’ ” of the parties challenging the action. SOCAL, 449 U.S. at 239, 101 S.Ct. at 493 (quoting Abbott Laboratories, 387 U.S. at 151-52, 87 S.Ct. at 1516-17). These indicia of finality are ordinarily controlling because they are highly probative of whether the agency’s position is merely tentative or, on the other hand, whether the agency views its deliberative process as sufficiently final to demand compliance with its announced position. The interest in postponing review is powerful when the agency position is tentative. See, e.g., Public Citizen Health Research Group v. Commissioner, FDA, 740 F.2d 21, 31 (D.C.Cir.1984); Continental Air Lines, 522 F.2d at 125. Judicial review at that stage improperly intrudes into the agency’s deci-sionmaking process. It also squanders judicial resources since the challenging party still enjoys an opportunity to convince the agency to change its mind. See Public Citizen Health Research Group, 740 F.2d at 31; Continental Air Lines, 522 F.2d at 125. Once the agency publicly articulates an unequivocal position, however, and expects regulated entities to alter their primary conduct to conform to that position, the agency has voluntarily relinquished the benefit of postponed judicial review.

Both the criteria of “definitiveness” and “direct and immediate effect” suggest that EPA’s position is final. The March 1985 letter to Ciba-Geigy from EPA’s Director of Pesticide Programs unequivocally stated EPA’s position on the question whether registrants were entitled to a cancellation hearing before labeling changes could be required. Not only did the statement of position admit of no ambiguity, cf. Action Alliance of Senior Citizens v. Heckler, 789 F.2d 931, 940 (D.C.Cir.1986) (issue may be unfit for judicial review when “further administrative action is needed to clarify the agency’s position”), but it gave no indication that it was subject to further agency consideration or possible modification. Cf. SOCAL, 449 U.S. at 241, 101 S.Ct. at 493 (agency statement of position held not definitive when “[i]t represents a threshold determination that further fdinquiry is warranted”); Abbott Laboratories, 387 U.S. at 149, 87 S.Ct. at 1515 (“[N]o claim is made here that further administrative proceedings [concerning issue tendered for judicial review] are contemplated.”); Eagle-Picher Industries v. United States EPA, 759 F.2d 905, 917 (D.C.Cir.1985) (absence of “equivocal or tentative language” indicates that position was sufficiently final for judicial review). The letter emphatically required Ciba-Geigy’s “ ‘immediate compliance.’ ” SOCAL, 449 U.S. at 239, 101 S.Ct. at 493 (quoting Abbott Laboratories, 387 U.S. at 152, 87 S.Ct. at 1517). Moreover, we have no reason to believe that the EPA Director of Pesticide Programs lacks authority to speak for EPA on this issue or that his statement of the agency’s position was “only the ruling of a subordinate official” that could be appealed to a higher level of EPA’s hierarchy. Abbot Laboratories, 387 U.S. at 151, 87 S.Ct. at 1516 (citing & Co. v. Wickham, 230 F.Supp. 398, 409 (S.D.N.Y.1964), aff'd, 364 F.2d 241 (2d Cir.1966), cert. denied, 385 U.S. 1036, 87 S.Ct. 776, 17 L.Ed.2d 683 (1967)). The follow-up letter from EPA was equally definitive, reiterating “the Agency position” that Ciba-Geigy had no statutory right to a cancellation hearing and that the Company must conform to the new labeling requirement on pain of civil and criminal penalties. J.A. at 72.

In addition to its “practical effect,” SOCAL, 449 U.S. at 242, 101 S.Ct. at 494, EPA’s interpretation of FIFRA has a significant “legal ... effect” on Ciba-Geigy. Id. It is well settled that “[t]he authoritative interpretation of an executive official has the legal consequence, if it is reasonable and not inconsistent with ascertainable legislative intent, of commanding deference from a court that itself might have reached a different view if it had been free to consider the issue as on a blank slate.” NALCC, 443 F.2d at 697. See generally Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). We can divine no reason why the letter from the head of the EPA’s Pesticide Division, speakding for the agency charged with administering FIFRA, would not be entitled to deference from the least dangerous branch. EPA’s steadfast failure to initiate a cancellation proceeding, coupled with the representations of its counsel that EPA construes its statute not to require such a hearing before imposing labeling changes, only serves to confirm the finality of the agency’s pre-litigation position. Compare Church of Scientology v. Internal Revenue Service, 792 F.2d 153, 162 n. 3 (D.C.Cir.1986) (en banc), with id. at 164-66 (Silberman, J., concurring).

Under these circumstances, we see not the slightest danger that judicial review will disrupt the orderly process of administrative decisionmaking. See, e.g. Bell v. New Jersey, 461 U.S. 773, 779, 103 S.Ct. 2187, 2191, 76 L.Ed.2d 312 (1983); SOCAL, 449 U.S. at 242, 101 S.Ct. at 494. Having definitively stated its position that Ciba-Geigy has no statutory right to a cancellation hearing, EPA has provided its final word on the matter “[s]hort of an enforcement action.” Harrison v. PPG Industries, Inc., 446 U.S. 578, 586, 100 S.Ct. 1889, 1894, 64 L.Ed.2d 525 (1980); see also Port of Boston Marine Terminal Association v. Rederiaktiebolaget Transatlantic, 400 U.S. 62, 71, 91 S.Ct. 203, 209, 27 L.Ed.2d 203 (1970); Frozen Food Express v. United States, 351 U.S. 40, 44, 76 S.Ct. 569, 571, 100 L.Ed. 910 (1956); cf. Chicago & Southern Air Lines, Inc. v. Waterman Steamship Corp., 333 U.S. 103, 112-13, 68 S.Ct. 431, 436-37, 92 L.Ed. 568 (1948) (administrative orders reviewable when they “deny a right ... as a consummation of the administrative process”). With the agency at rest in this respect, judicial review now will hasten, not delay, resolution of the ultimate question whether the Act requires a cancellation hearing before EPA may impose labelling changes. Cf. SOCAL, 449 U.S. at 242, 101 S.Ct. at 494. Nor will judicial review jeopardize the public health or safety. Ciba-Geigy has complied with EPA’s labeling changes to date and will presumably continue to do so unless a court holds that the Company is entitled to a cancellation hearing. See J.A. at 13; cf. Abbott Laboratories, 387 U.S. at 156, 87 S.Ct. at 1519. We conclude, as this court has repeatedly held before, that “an agency’s interpretation of its governing statute, with the expectation that regulated parties will conform to and rely on this interpretation, is final agency action fit for judicial review.” Independent Bankers Association v. Smith, 534 F.2d 921, 929 (D.C.Cir.) (citations omitted), cert. denied, 429 U.S. 862, 97 S.Ct. 166, 50 L.Ed.2d 141 (1976). Respect for our coordinate branch of government, as well as fidelity to precedent and common sense, allows for no other conclusion.

The second branch of the ripeness inquiry requires consideration of the hardship that Ciba-Geigy will incur if judicial review is postponed. In our view, the hardship here is indistinguishable from that deemed compelling by the Supreme Court in Abbott Laboratories. Just as FDA did in that case, here EPA “purport[s] to give an authoritative interpretation of a statutory provision that has a direct effect on the [Company’s] day-to-day business.” 387 U.S. at 152, 87 S.Ct. at 1517. The costs of compliance for Ciba-Geigy may be even greater than those the Supreme Court found onerous for Abbott Laboratories. In its complaint, Ciba-Geigy asserted that it would suffer a substantial drop (estimated at 50 percent) in sales due to warnings contained on the EPA-mandated labeling. On appeal, the Company contends that it “continues to suffer economic loss, including reduced sales, erosion of market share and loss of goodwill, as farmers turn to competing products.” Appellant’s Brief at 6 n. 3; see supra note 3. The Company’s only alternative to costly compliance with EPA’s regulatory directive would be to run the risk of serious civil and criminal penalties for unlawful distribution of “misbrand-ed” products. That is the very dilemma the Court found sufficient to warrant judicial review in Abbott Laboratories. Cf. SOCAL, 449 U.S. at 242, 244, 101 S.Ct. at 494, 495 (litigation expenses were only hardship to challenging party of delaying review).

For the foregoing reasons, we conclude that the issue presented is fit for judicial review and that EPA’s action imposes a sufficient hardship to warrant review now. The court’s and agency’s interests in postponing review are relatively slight, whereas the regulated entity faces “irremediable adverse consequences” each day that judicial review is delayed. Toilet Goods Association v. Gardner, 387 U.S. 158, 164, 87 S.Ct. 1520, 1524, 18 L.Ed.2d 697 (1967). Under those circumstances, we discern no principled justification for refusing to relieve Ciba-Geigy “of an onerous legal uncertainty.” Continental Air Lines, 522 F.2d at 128.

By virtue of its disposition of the case, the District Court had no occasion to address the merits of the statutory question presented by the complaint. Similarly, the parties’ arguments on appeal were devoted almost exclusively to the ripeness issue. We therefore vacate the judgment and remand the case to the District Court for resolution of the FIFRA issue. See International Union, UAW v. Brock, 783 F.2d 237, 251 (D.C.Cir.1986); cf. Abbott Laboratories, 387 U.S. at 156, 87 S.Ct. at 1519.

So ordered.

APPENDIX

SIMAZINE TELEGRAM

BY CERTIFIED LETTER DATED JULY 30, 1984, YOU WERE NOTIFIED OF REQUIRED LABEL CHANGES FOR THESE PESTICIDES. THESE REQUIREMENTS WERE TO ADD A RESTRICTED USE CLASSIFICATION FOR CERTIFIED APPLICATORS AND A GROUNDWATER ADVISORY STATEMENT. WE HAVE REVISED THE GROUNDWATER ADVISORY STATEMENT AS SHOWN BELOW. THESE REQUIREMENTS ARE TO BE PLACED ON LABELS FOR THE ABOVE PESTICIDE© ENTERING CHANNELS OF TRADE AS OF JANUARY 30, 1985. AFFECTED STOCKS SHIPPED AFTER THAT DATE WITHOUT THE REQUIRED CHANGES WILL BE CONSIDERED MISBRAND-ED.

THE LABEL MUST BEAR THE FOLr LOWING RESTRICTED USE STATEMENT AT THE TOP OF THE FRONT PANEL:

******

FIVE COPIES OF REVISED LABEL FOR EACH AFFECTED PRODUCT MUST BE SUBMITTED WITHIN 30 DAYS OF RECEIPT OF THIS MAIL-GRAM. IF REVISED LABELS ARE NOT SUBMITTED, IT WILL BE NECESSARY TO TAKE STEPS TO CANCEL THE REGISTRATION(S).

J.A. at 62-63.

. If the registered product is found to pose an "imminent hazard,” the EPA may suspend the registration immediately pending a cancellation hearing. Id. § 136d(c)(1). The registrant, in turn, has the right to an "expedited hearing before the Agency on the question of whether an imminent hazard exists.” Id.

. The pertinent portions of the mailgram are reproduced in the Appendix to this opinion. The language, which our dissenting colleague believes was merely "suggested in passing," Dissent at 441, speaks for itself.

. We are informed that since the filing of its complaint, Ciba-Geigy has changed the labeling of five simazine products to conform to EPA’s new requirements and has stopped selling its six other simazine products.

. EPA also stated in the letter that, although it would continue to require immediate compliance with new label warnings concerning groundwater contamination, it had decided to seek restricted use classification of simazine through a cancellation proceeding or a rulemak-ing. The agency further agreed that it would not bring any misbranding enforcement action against Ciba-Geigy for omitting a statement of the restricted use classification on its simazine labeling until Ciba-Geigy had an opportunity to present its views regarding the need for such a change in classification at a cancellation hearing or rulemaking. Ciba-Geigy thereupon dismissed voluntarily that part of its complaint challenging EPA’s method for enforcing the proposed restricted use classification.

. With respect to its decision to reclassify sima-zine for restricted use, EPA did issue a notice of intent to cancel simazine’s general use registration. See supra note 4. The FIFRA Scientific Advisory Panel, however, found that existing no toxic effects to humans after 27 years of extensive use of adequate until more detailed studies can be completed and reviewed.” Appellant's Brief (Addendum 2 at 2).

. The dissent’s contention that ”[t]he case or controversy requirement strongly suggests that there can be no such creature [as a pure question of law]” is difficult to fathom. Dissent at 443 n. 3. The term "pure question of law” merely reflects the truism that a case or controversy sometimes turns entirely on an issue of law where the facts are not in dispute.

. The dissent charges that our pragmatic approach to finality "suggests a casual treatment of the plain language” of the statutory requirement of final agency action. Dissent at 443. This contention is, niceties aside, a thinly disguised attack on the Supreme Court’s interpretation of the statutory requirement of finality. See generally Mathews v. Eldridge, 424 U.S. 319, 331 n. 11, 96 S.Ct. 893, 901 n. 11, 47 L.Ed.2d 18 (1976).

Even if we were at liberty to reject the teachings of Abbott Laboratories and its progeny, which we emphatically are not, we would find the dissent’s criticism unpersuasive. We question the premise that the phrase “final agency action,” 5 U.S.C. § 704 (1982), conveys some settled, inflexible meaning that precludes pragmatic or functional considerations. See also 7 U.S.C. § 136n(a) (FIFRA provision authorizing judicial review of "final Agency actions”). In particular, we are unpersuaded that the statutory language prohibits us from considering whether final agency action has resulted from a series of agency pronouncements rather than a single edict. Nor does the dissent advance any principled reason for its refusal to consider the cumulative effect of the agency’s actions on Ciba-Geigy and its alleged statutory right. Its approach is the familiar one of divide and conquer.

But Congress gave no indication that it intended the finality requirement to be applied in the hypertechnical fashion championed by the dissent. To the contrary, the legislative history of § 704 suggest that Congress was merely codifying the self-imposed judicial practice of exercising restraint in reviewing tentative agency action. See generally Carter/Mondale Presidential Comm., Inc. v. FEC, 711 F.2d 279, 284 n. 9 (D.C.Cir.1983).

. Under logic and settled law, the fact that the letter was a response to inquiries by Ciba-Geigy did not preclude the agency from expressing a final position in that document. See Harrison v. PPG Indus., Inc., 446 U.S. 578, 583, 100 S.Ct. 1889, 1893, 64 L.Ed.2d 525 (1980). But see Dissent at 444.

The dissent asserts that by considering EPA’s March 1985 letter we improperly sustain jurisdiction on a theory not advanced by plaintiff. Dissent at 441. But, as noted supra at page 432, the complaint expressly identifies the March 1985 letter as one of a series of steps taken by EPA that had the practical effect of imposing labeling changes on Ciba-Geigy without affording it a hearing. J.A. at 9. Unlike the dissent, which would apparently bring back code pleading and overturn Abbott Laboratories in one fell swoop, we do not believe that the failure of the complaint specifically to label the March letter as a "final order” precludes us from considering whether that letter sufficiently clarified the action taken by the agency in the December mailgram to render that action ripe for judicial review.

In our view, it is the dissent that distorts the substance of the complaint in order to deny jurisdiction on a theory not advanced by the plaintiff. The dissent would find Ciba-Geigy’s challenge unripe on the ground that ”[a] threat to commence misbranding proceedings is equivalent to an agency’s ‘probable cause’ determination or preliminary finding that enforcement proceedings are justified. Such actions have long been thought to lie outside the realm of ‘final agency action.’ ’’ Dissent at 442-43 (citations and footnote omitted).

The analogy to probable cause determinations would indeed be controlling, as Ciba-Geigy commendably concedes and we forthrightly acknowledge, if the Company were seeking a declaratory judgment that the available scientific evidence does not warrant a misbranding action. But the complaint before us seeks no such relief; rather, it is based on the entirely separate legal theory that the Act requires EPA to bring a cancellation hearing when it wants to change the labeling requirements for a registered pesticide. Because the complaint states a colorable allegation that Congress “has indicated an intent to circumscribe agency enforcement discretion, and has provided meaningful standards for defining the limits of that discretion,” Heckler v. Chaney, 470 U.S. 821, 105 S.Ct. 1649, 1657, 84 L.Ed.2d 714 (1984), we are not at liberty to decline jurisdiction for fear of interfering with prosecutorial discretion. Cf. Leedom v. Kyne, 358 U.S. 184, 79 S.Ct. 180, 3 L.Ed.2d 210 (1958).

. We are aware that the formality attending an agency action may be helpful in determining whether the action is reviewable. See Abbott Laboratories, 387 U.S. at 151, 87 S.Ct. at 1516. It is settled, however, that an agency may not avoid judicial review merely by choosing the form of a letter to express its definitive position on a general question of statutory interpretation. See NALCC, 443 F.2d at 701. Moreover, to hold that an agency may not adopt a final interpretation of its statute without following formal procedures would fly in the teeth of the admonition delivered time and again that agencies, not courts, are to be the shapers and craft-ers of agency procedures consistent with statutory constraints. See, e.g., Vermont Yankee Nuclear Power Corp. v. Natural Resources Defense Council, Inc., 435 U.S. 519, 98 S.Ct. 1197, 55 L.Ed.2d 460 (1978). Because "administrative reconsideration of the ruling seems quite unlikely,” we do not find the relatively informal nature of the agency ruling here to be grounds for postponing review. Independent Bankers Ass'n, 534 F.2d at 929; cf. New York Stock Exchange, Inc. v. Bloom, 562 F.2d 736, 741 (D.C.Cir.1977) (informal opinion letter held not ripe for review where the letter expressly reserved the possibility that agency's view might change if agency were presented with certain evidence), cert. denied, 435 U.S. 942, 98 S.Ct. 1520, 55 L.Ed.2d 538 (1978).

. Ciba-Geigy’s alleged economic loss clearly constitutes a "distinct and palpable” injury, Worth v. Seldin, 422 U.S. 490, 501, 95 S.Ct. 2197, 2206, 45 L.Ed.2d 343 (1975), that "fairly can be traced to the challenged action” and "is likely to be redressed by a favorable decisipn,” Simon v. Eastern Kentucky Welfare Rights Org., 426 U.S. 26, 38, 41, 96 S.Ct. 1917, 1924, 1925, 48 L.Ed.2d 450 (1976). If the Company prevails on the merits of its complaint, it may lawfully disregard EPA’s new labeling requirements for si-mazine until it has been afforded the opportunity to challenge them at a formal, public hearing. Thus, the dissent plainly errs in contending that "[t]he legal issue which the majority believes was properly before the district court ... has no direct effect on anyone, including the appellant.” Dissent at 442, see also id. at 440 n. 1 (complaint arguably nonjusticiable "academic debate over points of law”).

The dissent nevertheless argues that Ciba-Gei-gy’s claim is unripe for judicial review because the Company has complied with EPA’s labeling requirement rather than risk civil and criminal enforcement action for non-compliance. Dissent at 440 & n. 1. Relying primarily on International Longshoreman’s Union Local 37 v. Boyd, 347 U.S. 222, 74 S.Ct. 447, 98 L.Ed. 650 (1954), the dissent disregards the Supreme Court’s more recent pronouncements on the law of ripeness, which "reflect[ ] a greater judicial willingness to aid litigants faced with the necessity of risking substantial harm in order to challenge the validity of governmental action.” Joseph v. United States Civil Serv. Comm’n, 554 F.2d 1140, 1151 (D.C.Cir.1977). In particular, the dissent evidently feels free to reject the principle laid down in Abbott Laboratories and faithfully adhered to by this court on numerous occasions that agency action is generally ripe for review when it places a regulated entity in the dilemma of enduring costly compliance measures or risking civil and criminal penalties. See, e.g., Abbott Laboratories, 387 U.S. at 152-53, 87 S.Ct. at 1517-18; Continental Air Lines, 522 F.2d at 124-28 (en banc). That the lapse of time since judicial review was sought has forced Ciba-Gei-gy to choose one of its disadvantageous options hardly provides a principled basis for distinguishing Abbott Laboratories.

. Under Abbott Laboratories, it is clear that Ciba-Geigy’s complaint should not be held unripe merely because EPA has not specified the exact type of enforcement proceeding it is likely to bring against the Company. See Abbott Laboratories, 387 U.S. at 153 & n. 19, 87 S.Ct. at 1518 & n. 19. But see Dissent at 443 n. 2. It is enough that the agency has put to Ciba-Geigy the "hard choice between compliance certain to be disadvantageous and a high probability of strong sanctions.” Tennessee Gas Pipeline Co. v. FERC, 736 F.2d 747, 751 (D.C.Cir.1984); see Abbott Laboratories, 387 U.S. at 153, 87 S.Ct. at 1517 (noting "risk ” of serious criminal and civil penalties) (emphasis added).

It would be inadmissible to attribute Ciba-Geigy’s dilemma solely to the statute itself and not to EPA’s interpretation. First, such an approach would depend on acceptance of EPA's view of the merits, that is its interpretation of FIFRA. But when " '[t]he issue of harm and the issue on the merits are intertwined,’ ” we must assume the challenging party’s view of the merits in determining ripeness. Better Gov’t Ass'n v. Department of State, 780 F.2d 86, 94 (D.C.Cir.1986) (quoting National Wildlife Fed’n v. Snow, 561 F.2d 227, 237 (D.C.Cir.1976)). Second, as we have observed, EPA's interpretation of FI-FRA has independent legal consequences under settled principles of judicial deference to an agency’s interpretation of its statute. See supra pp. 437-38.