Plaintiffs hereby oppose Defendants’ motion to dismiss for lack of subject matter jurisdiction. As discussed further herein, the court has ample jurisdiction to adjudicate the case, and Defendants’ motion should therefore be denied.

The complaint in this case, which seeks declaratory and injunctive relief, was filed October 27, 2000. On January 29, 2001, Plaintiffs moved for a preliminary injunction, requesting that the Court bar Defendants, during the pendency of this case, from publicly releasing as final a forthcoming EPA report entitled, "Exposure and Human Health Reassessment of 2,3,7,8-Tetrachlorodibenzo-p-Dioxin (TCDD) and Related Compounds" (hereinafter "dioxin reassessment"). Pursuant to a negotiated schedule, Defendants filed their motion to dismiss on February 5, 2001. The parties are filing their respective oppositions to these motions today, and replies will be filed April 6. The Court has scheduled a hearing on the two pending motions for April 20, 2001.

Discovery is proceeding on three issues of fact raised in Defendants’ motion to dismiss: (i) whether EPA uses the cancer assessment guidelines as binding directives on agency officials charged with making cancer assessments; (ii) what consequences the dioxin reassessment will have for Plaintiffs or other members of the public; and (iii) what consequences EPA’s April 8, 1999, "Cancer Assessment Document -- Evaluation of the Carcinogenic Potential of Pyrethrins -- Final Report" ("1999 Final Report") (see Compl. Exh. 2) will have for Plaintiffs or other members of the public. Pursuant to Federal Rule 30(b)(6), Plaintiffs have noticed depositions of EPA officials with direct knowledge of these facts and have sought EPA documents relating to these issues. Although that discovery is now underway, it is unlikely to be completed prior to the hearing on April 20.

On March 13, 2001, EPA’s Science Advisory Board ("SAB") publicly released a draft report of the SAB’s Dioxin Reassessment Review Subcommittee ("DRRS"). That report reached a conclusion regarding hazard characterization contrary to the conclusion stated in the draft dioxin reassessment that was released in May 2000. The May 2000 draft report concluded that dioxin was a "human carcinogen". The SAB report released last week states, "[m]ost DRRS Members do not support the classification of TCDD as a human carcinogen". Cover letter to EPA Administrator Whitman, attached to SAB Executive Committee Review Draft, March 12, 2001 (Exh. 1) at 2¹ (emphasis added.) The SAB Executive Committee is scheduled to meet on April 11, 2001, to review the DRRS report and is expected to make a final recommendation to the agency shortly thereafter.

The final dioxin reassessment and the 1999 Final Report on pyrethrins are both final for purposes of review by this Court. Courts are to view the finality rule flexibly, and Defendants’ own characterization of the reports as non-final is not dispositive. Both reports constitute the culmination of major agency proceedings and will have palpable effects on Plaintiffs, in terms of both their informational harm and their regulatory consequences.

With respect to the Administrative Procedure Act ("APA") violations at issue, throughout the memorandum in support of their motion to dismiss ("Def. Mem."), Defendants mischaracterize Plaintiffs’ claims as alleging merely a violation of APA section 553 rulemaking requirements. See, e.g., Def. Mem. at 25 (alleging that section 553 violation is "absolutely essential to Plaintiffs’ case"). Defendants admit that EPA has failed to publish the 1996 or 1999 cancer guidelines as final (with any necessary responses to public comments). Defendants attempt to excuse this failure, however, by claiming that section 553 does not apply to EPA’s cancer assessment guidelines. Plaintiffs dispute this defense and allege that EPA is, in fact, using the cancer guidelines as substantive rules under APA section 553. The cancer assessment rules are binding on EPA reviewers, the decision as to which set of rules will apply is in many cases outcome-determinative, and the application of the guidelines imposes legal consequences on Plaintiffs.

Even if the Court were to conclude that formal rulemaking were not required, however, Defendants still have acted, and are acting, in violation of the APA. First, having adopted and published agency rules for carcinogen assessment in 1986, and having followed those rules for ten years, EPA was not free to depart from its settled policy without providing notice and a reasoned justification for the change in position. Although EPA did publish certain notices in the Federal Register in connection with the proposed 1996 guidelines, the agency has never explained the reason for its shift in policy on key aspects of the cancer guidelines. The absence of any agency rationale in this regard is confirmed by written statements of EPA’s own reviewing scientists as recently as last week. Second, by failing to declare the 1986 guidelines superseded, and by reserving the right to apply either the 1986, the 1996, or the1999 guidelines (or perhaps some combination thereof), EPA is simultaneously applying multiple and conflicting rules against similarly situated parties in an arbitrary and capricious manner. Thus, even putting aside the issue of rulemaking, Defendants’ motion to dismiss must be denied.

Defendants therefore face a Hobson’s choice with respect to their position on the cancer guidelines: Either the guidelines are binding on agency officials charged with making EPA cancer hazard classifications, or the guidelines are not binding. If they are binding, then, under Appalachian Power Co. v. EPA, 208 F.3d 1015 (D.C. Cir. 2000), the agency has violated APA section 553 by adopting substantive rules without publishing either the 1996 or the 1999 guidelines as final. If, on the other hand, the guidelines are not binding, then, without any reasoned explanation for its change in policy, the agency is applying multiple standards -- yielding substantively different conclusions for similar substances, and with respect to similarly situated parties -- in an unpredictable, arbitrary and capricious fashion.

All Plaintiffs in this case, including Plaintiffs Diatect and Brevet, have standing. Plaintiffs satisfy Article III requirements in that they (i) have a reasonable concern of harm, which (ii) is clearly linked to EPA’s publication of the reports at issue, and which (iii) could be redressed by an order from the Court setting aside the reports.

Finally, Defendants’ memorandum presents no argument regarding EPA’s violation of the Congressional Review Act, 5 U.S.C. § 801, et. seq. ("CRA"), beyond the argument Plaintiffs anticipated, and refuted, in their application for preliminary injunction on January 29. The Court should therefore allow Plaintiffs’ CRA claim to move forward.

I. Defendants Fail to Satisfy the Legal Standard for Motions to Dismiss.

In ruling on a motion to dismiss, a court must construe the allegations in the complaint in the light most favorable to the plaintiff. See, e.g., Hohri v. United States, 782 F.2d 227, 241 (D.C. Cir. 1986), vacated on other grounds, 482 U.S. 64 (1987). In evaluating a motion to dismiss for failure to state a claim upon which relief may be granted, a court must accept the allegations in the complaint as true. See, e.g., Croixland Properties Ltd. Partnership v. Corcoran, 174 F.3d 213, 215 (D.C. Cir. 1999). All reasonable inferences must be drawn in favor of the plaintiff, and a court should only dismiss a complaint for failure to state a claim "if it is clear that no relief could be granted under any set of facts that could be proved consistent with the allegations." Id. (quoting Hishon v. King & Spalding, 467 U.S. 69, 73 (1984)); see also Price v. Crestar Secs. Corp., 44 F. Supp. 2d 351, 353 (D.D.C. 1999). A court "does not test whether the plaintiff will prevail on the merits, but instead whether the claimant has properly stated a claim." Price, supra, 44 F. Supp. 2d at 353.

Here, the Court must assume that Plaintiffs’ allegations, including those regarding Defendants’ use of the cancer risk assessment guidelines, the dioxin reassessment, and the 1999 Final Report on pyrethrins, are true. Unless Defendants are able to demonstrate that "no relief could be granted under any set of facts . . . consistent with the allegations", the motion to dismiss must be denied. Croixland Properties, supra, 174 F.3d at 215. Defendants have failed to meet this heavy burden.

II. Plaintiffs Have Sufficiently Alleged Final Agency Action.

The APA makes reviewable "final agency action for which there is no other adequate remedy in a court". 5 U.S.C. § 704. There is a strong presumption in favor of judicial review of agency action under the APA. Bowen v. Michigan Academy of Family Physicians, 476 U.S. 667, 670 (1986). The Supreme Court has recognized that the term "agency action"² is to be interpreted expansively, as it "brings together previously defined terms . . . to assure the complete coverage of every form of agency power." Federal Trade Comm’n v. Standard Oil Co. of California, 449 U.S. 232, 238 n. 7 (1980), quoted in Synthetic Organic Chem. Mfrs. Ass’n v. Secretary, DHHS, 720 F. Supp. 1244, 1249 (W.D. La. 1989) ("SOCMA"). Courts are to take a "pragmatic" and "flexible" approach in determining whether final agency action has occurred. Abbott Labs. v. Gardner, 387 U.S. 136, 149-50 (1967).

Where the threat of harm is imminent, as with the publication of the dioxin reassessment in this case, a court should intercede in time to prevent the threatened harm. Chemical Waste Mgmt. Inc. v. United States EPA, 869 F.2d 1526, 1533 (D.C. Cir. 1989) ("where the likelihood of future harm is demonstrably high, it is often appropriate for courts to intervene before the future feared event occurs.") (quoting Friends of Keeseville, Inc. v. F.E.R.C., 859 F.2d 230, 234 (D.C. Cir. 1988)); Ciba-Geigy Corp. v. United States EPA, 801 F.2d 430, 436-37 (D.C. Cir. 1986) (noting importance of "practical effect" of agency’s pesticide labeling changes on plaintiff).

An agency’s own characterization of finality is not decisive in determining when "final agency action" has occurred for purposes of appellate review. Appalachian Power, supra, 208 F.3d 1015, 1022-23 (D.C. Cir. 2000) (rejecting EPA characterization of science policy guidance as non-final); Natural Resources Defense Council v. EPA, 22 F.3d 1125, 1132-33 (D.C. Cir. 1994); Carter/Mondale Presidential Campaign v. Federal Election Comm’n, 711 F.2d 279, 289 & n. 17 (D.C. Cir. 1983) (citing Fidelity Television, Inc. v. FCC, 502 F.2d 443, 448 (D.C. Cir. 1974)); American Farm Bureau v. EPA, 121 F. Supp. 84, 105-106 (D.D.C. 2000) (holding EPA science policy was final agency action for purposes of surviving motion to dismiss); see also Dow Chem., U.S.A. v. Consumer Product Safety Comm’n, 459 F. Supp. 378, 384 & n.5, 385-87 (W.D. La. 1978) (holding that "interim policy statement", pursuant to which CPSC had made "provisional classification" of perchlorethylene as Category A carcinogen, was final agency action). Whether final agency action has occurred for purposes of APA review should not depend on semantic characterizations but rather on a "realistic assessment of the nature and effect" of the agency action. Fidelity Television, supra, 502 F.2d at 448. The Court should therefore view with a critical eye Defendants’ arguments that there is no final agency action to support judicial review.

A. The Imminent Dioxin Reassessment is Final Agency Action.

Defendants contend that, because the dioxin and pyrethrins reassessments do not have direct regulatory effects, or "regulatory consequences per se", EPA’s issuance of the reports is nonreviewable. Def. Mem. at 15, 20. Like the government carcinogen report held reviewable in SOCMA, however, both the dioxin reassessment and the Final Report on pyrethrins will have "substantial regulatory impact" as a practical matter, as well as significant economic consequences for affected parties, and they therefore are reviewable as "a decisional pronouncement affecting legal rights and obligations". See Bennett v. Spear, 520 U.S. 154, 117 S. Ct. 1154 (1997) (holding Interior Department report reviewable under APA); Troy Corp. v. Browner, 120 F.3d 277 (D.C. Cir. 1997) (enjoining listing of two substances in EPA’s Toxics Release Inventory because agency failed to follow its guidelines).

With respect to the dioxin report, issuance of the draft reassessment as final will have tremendous impact on EPA policy as a practical matter. The agency has reportedly developed a national action plan that employs a "multimedia approach" to deal with perceived health risks. See Risk Policy Report, Feb. 19, 2001 at 23 (attached hereto as Exhibit 2). EPA is ready to launch the plan following the meeting of the agency’s Science Advisory Board dioxin reassessment (now set for April 11, 2001). Id. Major policy shifts are also expected in EPA’s waste and water offices. Id.

Defendants cite only one case in support of their argument that the dioxin reassessment is non-reviewable because it does not represent the "consummation of EPA’s decisionmaking" (Def. Mem. at 23-24), and that case is inapposite. Unlike the Plaintiffs in this case, the plaintiffs in Pacific Gas & Elec. Co. v. Federal Power Comm’n, 506 F.2d 33 (D.C. Cir. 1974), were not faced with "immediate and substantial harm" from the agency action, a distinction noted later in Dow Chem. Co. v. CPSC, 464 F. Supp. 904, 910 (W.D. La. 1979).

Ignoring the threat of immediate harm, Defendants invite Plaintiffs to await a long series of events before appealing to the court to prevent the harms attendant with publication of the dioxin reassessment. Def. Mem. at 7 ("...any faults in the reassessment could furnish a basis for public comment, administrative challenge (in some contexts) and, after issuance of final agency action, judicial review.") The Administrative Conference of the United States has criticized such arguments, however, as a basis for shielding agency "policy statements" from judicial review:

Of course, affected persons could undergo the application of the policy to them, exhaust administrative remedies and then seek judicial review of such denials or enforcement actions, at which time they may find that the policy is given deference by the courts. The practical consequence is that this process may be costly and protracted, and that affected parties have neither the opportunity to participate in the process of policy development nor a realistic opportunity to challenge the policy when applied within the agency or on judicial review. The Conference believes this outcome should be avoided.. . .
* * *

Administrative Conference Recommendation 92-2, "Agency Policy Statements," 1 C.F.R. 305.92-2 (1993) (adopted June 18, 1992).³

Moreover, it is well established that immediate review of agency action is available where "irremediable adverse consequences flow from requiring a later challenge". Toilet Goods Ass’n v. Gardner, 387 U.S. 158, 164 (1967). Where the happening of the agency action sought to be prevented will divest the court of power to prevent the threatened harm to plaintiffs, the court need not wait for "consummation" of all the agency processes. Compare Pfizer, Inc. v. Shalala, 182 F.3d 975, 979 (D.C. Cir. 1999) (declining to review agency action where opportunity for "meaningful judicial review" was not foreclosed). Defendants ignore the fact that Plaintiff Brevet will be unable to recoup its lost sales or to recover for damages to its business reputation caused by the dioxin reassessment in a later judicial action. Thus, even if the final dioxin reassessment does not constitute the "consummation" of EPA’s decision making -- which it clearly does for purposes of the finality analysis -- the absence of meaningful judicial remedy at a later time renders EPA’s release of the report reviewable now.

Defendants’ reliance on Action on Smoking and Health v. Department of Labor, 28 F.3d 162 (D.C. Cir. 1994), is therefore misplaced. In that case the petitioner made no claim that OSHA’s delay in issuing health and safety standards for environmental tobacco smoke jeopardized the court’s future power of review. Id. at 165. The case concerned the claim that OSHA’s proposed rulemaking would violate the regulatory timetable of the agency’s own cancer policy, and the court found that the claim of future delay was not ripe for review. Id. at 163. No comparable claim or facts are present here.

Reviewable agency action is not limited to an agency’s imposition of regulatory restrictions, as Defendants would have the Court believe. An agency’s publication of damaging information in itself may constitute final action reviewable in court. See, e.g., Block v. Meese, 793 F.2d 1303, 1309 (D.C. Cir.) (reviewing Department of Justice classification of environmental films as political propaganda where alleged injury was based on public perception), cert. denied, 478 U.S. 1021 (1986). In SOCMA, the court held that an agency’s publication of a report listing known or reasonably anticipated human carcinogens "is agency action even though it is informational and imposes no sanctions or obligations." SOCMA, supra, 720 F. Supp. at 1249. See also Independent Broker-Dealers’ Trade Ass’n v. SEC, 442 F.2d 132, 142, 143 (D.C. Cir.) (implying that APA review might be proper where agency publicity pressure, itself possibly ultra vires, leads party to take action that injures another), cert. denied, 404 U.S. 828 (1971); Dow Chem. v. Consumer Prod. Safety Comm’n, 459 F. Supp. 337, 386 (W.D. La. 1978) ("‘moral suasion’ is a considerably potent force in our society").

Defendants rely heavily on Industrial Safety Equip. Ass'n, Inc. v. EPA, 837 F. 2d 1115 (D.C. Cir. 1988), for the blanket assertion that an agency’s publication of information, even false and damaging information, cannot constitute reviewable agency action. The court in Industrial Safety was careful to point out, however, that statutory categories of agency action "are imprecise", and determinations of reviewable agency action are to made on a "case-by-case basis". Id. at 1117. In Industrial Safety, the court addressed contentions that EPA had failed to follow notice-and-comment procedures required for substantive rules under APA section 553. Id. at 1116, 1119, 1121 & n.11. Unlike the Plaintiffs in this case, the plaintiffs in Industrial Safety did not challenge the agency’s action as "arbitrary and capricious" under APA section 706, nor, as stated in the opinion, did they allege that the agency’s dissemination of the damaging information was "false". Id. at 1122. The Plaintiffs here have therefore raised arguments that were not addressed in Industrial Safety.

A later federal court distinguished the report in Industrial Safety from an EPA report on carcinogenicity strikingly similar to the reports at issue here. In Flue-Cured Tobacco Co-op. Stabilization Corp. v. U.S. EPA, 857 F. Supp. 1137 (M.D.N.C. 1994), the court explained:

The guide [at issue in Industrial Safety], however, was quite different from the Report [classifying second-hand tobacco smoke as a known human carcinogen] at issue in this case.

In taking a narrow and legalistic analytical approach to the question before it, the D.C. Circuit found that the publication of a guide by EPA and the National Institute for Occupational Safety and Health ("NIOSH") which recommended the use of certain asbestos-protection respirators over others did not constitute agency action. The guide, however, was quite different from the Report at issue in this case. To begin, the guide was descriptive, emphasizing an ideal, 837 F.2d at 1120; therefore it was advisory. In contrast, the Report is declaratory: It states that ETS is a known human carcinogen and backs up its statement through scientific data purportedly analyzed in accordance with agency procedural guidelines. Next, the NIOSH guide was not issued under a specific statutory authorization to distribute the information, see 656 F. Supp. at 855, whereas the Report was issued under such authority. In addition, the Report was issued pursuant to notice-and-comment procedures; this court's research indicates that the guide was not so issued. Further, the Report has been used to justify regulations by other agencies; again, this court's research yields no example of such a use of the guide. Finally, the D.C. Circuit implied that its decision might have come out differently had the agency issued the guide with the intent of penalizing a party, especially if the information contained in the guide were false. See 837 F.2d at 1119. This case presents just that situation, as Plaintiffs have alleged that "[t]he classification of ETS as a Group A carcinogen was intended to and in fact did falsely disparage plaintiffs' products...." (Complaint ¶ 86.)

Id. at 1143 (emphasis in original; footnote omitted) (further stating that Industrial Safety was only "superficially similar").⁴ See also NAACP, Jefferson County Branch v. Secretary of Labor, 846 F. Supp. 91, 98-99 (D.D.C. 1994) (distinguishing Industrial Safety and noting that, in Industrial Safety, the D.C. Circuit cautioned that "courts have made the threshold determination of reviewable agency action on a case-by-case basis").

EPA’s threatened publication of the draft dioxin reassessment, including the alarming conclusions that will directly and adversely affect Plaintiff Brevet, is therefore final agency action reviewable by this Court.

B. The 1999 Final Report on Pyrethrins is Final Agency Action.

Defendants stress that the 1999 Final Report on pyrethrins, which is plainly denominated a "Final Report" on its cover, was prepared by a subordinate committee as part of the FIFRA review process, and that it therefore does not represent the final word of the agency itself. Def. Mem. at 14. The D.C. Circuit has held, however, that a memorandum issued by a subordinate EPA official may constitute final agency action subject to judicial review where the document issues from "the director of the relevant component unit of the administration". Natural Resources Defense Council v. Thomas, 845 F.2d 1088, 1094 (D.C. Cir. 1988) (applying "flexible and pragmatic interpretation" in holding subordinate’s memorandum was final agency action) (citing Abbott Labs).

The 1999 Final Report on pyrethrins in fact represents the culmination of work by the Cancer Assessment Review Committee ("CARC") within EPA’s Health Effects Division. The cover of the document boldly states that it is a "Final Report", and the transmittal memorandum from the Executive Director of the CARC confirms that the report is the "Final Cancer Assessment Document". See Compl. Exh. 2 at 3-4. Understandably, pesticide watchdog groups have interpreted and publicized the report as a final determination by EPA that pyrethrins are likely human carcinogens. See Compl. Exh. 3 at 1; Compl. Exh. 4 at 14-15.

Defendants also attempt to downplay the finality of the 1999 Final Report by reference to a letter submitted to the agency by the Pyrethrins Joint Venture Committee, a non-party. (Def. Mem. at 11). This letter, which Defendants did not attach to their motion and which is not part of the record in this case, evidently supports Plaintiffs’ position that the 1999 Final Report is scientifically flawed. Far from calling into question the finality of the CARC report, however, the PJV letter, as Defendants have described it, merely confirms that a third party also disputes the agency’s findings regarding cancer effects from pyrethrins exposure. That EPA apparently has promised to evaluate additional pyrethrins data as they are produced -- much as it has promised to adopt new methods of carcinogen risk assessment as they emerge -- does not diminish the finality of the 1999 CARC report for purposes of judicial review. See Appalachian Power, supra, 208 F.3d at 1022 ("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.").

Defendants cite American Portland Cement Alliance v. EPA, 101 F.3d 772 (D.C. Cir. 1996), in support of their assertion that the 1999 Final Report on pyrethrins is not reviewable. Def. Mem. at 17. In American Portland Cement, the court held that EPA's administrative "determination" regarding hazardous waste regulation of kiln dust was not reviewable because the applicable statute (Resource Conservation and Recovery Act § 7006(a)(1)) "by its plain terms" provided for judicial review of only three types of EPA actions -- (1) promulgation of final regulations, (2) promulgation of requirements, and (3) denial of petition for promulgation, amendment, or repeal or regulations -- none of which included the kiln dust determination at issue. Here, there is no comparable statutory provision circumscribing the Court's APA review authority.

C. EPA’s Use of Draft Cancer Guidelines is Final Agency Action.

Like the Department of Health and Human Services’ adoption of specific criteria for listings in the Report on Carcinogens in SOCMA, EPA’s adoption of scientific principles for characterizing carcinogen hazards for its cancer assessments clearly falls within the scope of reviewable agency action. As the SOCMA court concluded, "The Secretary’s adoption of the Classification Procedures and Criteria fits well within the rubric of reviewable ‘agency action.’" 720 F. Supp. at 1249. Specifically, the SOCMA court found:

[T]he Criteria are "designed to implement" the statutory requirement that the Secretary classify substances as known or reasonably anticipated to be carcinogens and limit the Secretary's discretion in making future classification decisions. The Criteria thus constitute a "rule" as defined in [5 U.S.C.] § 551(4), subject to judicial review pursuant to § 702.

Id., 720 F. Supp. at 1249.

In Tozzi v. DHHS, Civ. No. 99-1170 (D.D.C. Sept. 30, 2000), Judge Emmet Sullivan ruled that Brevet, as an affected party, could challenge a proposed agency report listing dioxin as a known human carcinogen. The government had urged the court to disregard the above holding in SOCMA and to find that the report was not final and reviewable agency action. Although Judge Sullivan ultimately ruled in favor of the agency on the merits (a decision presently under appeal), the fact that the court reached the merits confirms the persuasiveness of SOCMA on the issue of reviewability. EPA’s use of similar criteria for carcinogen classifications here is likewise reviewable.

Defendants rely heavily on the finality analysis set forth in Bennett v. Spear, 520 U.S. 154, 117 S. Ct. 1154 (1997), and the Supreme Court’s rationale in finding final agency action in Bennett v. Spear, is indeed instructive. Like the Fish and Wildlife Service’s issuance of the biological opinion in Bennett, the actions of the Defendants here are only "virtually determinative" of the ultimate outcome -- the published agency conclusions that dioxin is a "human carcinogen" and that pyrethrins are "likely human carcinogens". See 117 S. Ct. at 1165. As in Bennett, however, "final agency action" has nevertheless occurred.

Moreover, even if the Court were to conclude that EPA’s use of draft cancer guidelines is not reviewable as a "final agency action" in the first instance, the use of draft guidelines is nevertheless reviewable as a "preliminary, procedural, or intermediate agency action or ruling" and is "subject to review on the review of the final agency action" (i.e., upon publication of the dioxin and pyrethrins reports). 5 U.S.C. § 704. Thus, if the Court finds that either the dioxin or the pyrethrins report is reviewable agency action, then the agency’s use of the non-finalized cancer guidelines in support of that report is also reviewable.

III. Defendants Have Violated the Administrative Procedure Act.

A. EPA’s Use of Non-Finalized Cancer Guidelines Violates The Rulemaking Requirements of APA Section 553.

Plaintiffs have alleged that directives from EPA officials to reviewing scientists instructing the scientists on which set of cancer guidelines to use in their work make the guidelines, as a factual matter, binding on the agency scientists. Discovery on this factual issue is now underway.⁵ While Defendants dispute the binding nature of the guidelines in their motion to dismiss, they have presented no examples of incidences where EPA scientists in fact have been permitted to disregard such instructions. To the contrary, as Defendants candidly point out (Def. Mem at 27), the D.C. Circuit in Chlorine Chemistry Council v. EPA, 206 F.3d 1286, 1290 (D.C. Cir. 2000), held that it was arbitrary and capricious for EPA to establish a maximum contaminant level goal for chloroform under the Safe Drinking Water Act that was at variance with the cancer guidelines.

That EPA has failed to pronounce the new draft or proposed rules as "final" goes to the heart of the notice and comment purpose of section 553. "In enacting the APA, Congress made a judgment that notions of fairness and informed administrative decisionmaking require that agency decisions be made only after affording interested persons notice and an opportunity to comment." Chrysler Corp. v. Brown, 441 U.S. 281, 316 (1979).

In McLouth Steel Products Corp. v. Thomas, 838 F.2d 1317 (D.C. Cir.1988), the D.C. Circuit ruled that an EPA model used to predict hazardous waste levels was a legislative rule subject to notice and comment requirements, rather than a general statement of policy. The court held that even though EPA had published Federal Register notices indicating it retained discretion to deviate from its use of the model, the model nevertheless was a substantive rule because EPA’s conduct demonstrated the binding character of the model. Id. at 1320-21.

The Federal Register notices that Defendants cite are insufficient to relieve the agency of its duty to provide notice and comment rulemaking. In denying a motion to dismiss in a similar case, the court in American Farm Bureau v. EPA, 121 F. Supp. 2d 84 (D.D.C. 2000) (Huvelle, J.), took judicial notice of EPA Federal Register notices describing the agency’s science policies, but it ruled that the notices "cannot defeat the fact that plaintiffs have set forth the necessary elements of a claim for failure to provide notice and comment." Id., 121 F. Supp. 2d at 106. The court in American Farm Bureau went on to state: "While it is entirely possible, if not likely, that EPA could prove, after discovery, that its science policies do not qualify as final agency action or are not binding rules, at the 12(b)(6) motion to dismiss stage the court is required to ‘accept as true all well-pleaded factual allegations and draw all reasonable inferences in favor of the plaintiff.’" Id., 121 F. Supp. 2d at 105-06 (citation omitted).

In the event that the ongoing discovery in this case confirms the conclusion of the D.C. Circuit in Chlorine Chemistry Council, i.e., that the so-called cancer "guidelines" are, in fact, binding on agency officials, then the agency’s failure to complete the notice and comment procedure by publishing the guidelines as final (with the necessary responses to public comment) would render the 1996 and 1999 cancer guidelines invalid. See Natural Resources Defense Council v. EPA, supra, 22 F.3d at 1146 (requiring notice and comment rulemaking, rather than informal guidance proceedings, to establish EPA performance standards for enhanced state vehicle inspection and maintenance programs under Clean Air Act). Following Judge Huvelle’s example in American Farm Bureau, the Court should therefore allow Plaintiffs an opportunity to uncover the facts necessary to support their rulemaking claim.⁶

B. EPA Has Failed to Provide a Reasoned Explanation for Abandoning the Settled Policy Established by the 1986 Final Guidelines.

It is axiomatic under federal administrative law that agency action based on a change in settled policy is arbitrary and capricious unless the agency formally announces the change in policy and supplies a reasoned explanation for the change of course. Motor Vehicle Mfrs. Ass’n v. State Farm, 463 U.S. 29, 57 (1983) ("an agency changing its course by rescinding a rule must supply a reasoned analysis"); Bell Atlantic Tel. Co. v. FCC, 206 F.3d 1, 8 (D.C. Cir. 2000) (vacating and remanding because of commission’s failure to provide "real explanation"); Troy Corp., supra, 120 F.3d at 286 ("Were the EPA to abandon a long-held exposure policy and take a new direction we would, as urged, require a thorough explanation of its reasons for doing so."); see also Abbs v. Sullivan, 756 F. Supp. 1172, 1187 (W.D. Wis. 1990) (holding change in agency position required notice and comment), vacated on jurisdictional grounds, 963 F.2d 918 (7th Cir. 1992).

Although Defendants quote liberally from EPA Federal Register statements regarding the agency’s plans for use of the cancer guidelines, what the Federal Register notices lack -- and what Plaintiffs challenge Defendants to cite -- is any published explanation of why the agency changed its position away from the 1986 guidelines on key aspects of cancer hazard assessment. Specifically, as Plaintiffs explained in their complaint (at ¶¶ 6, 9, 48), under the 1986 cancer guidelines, a substance cannot be categorized in the highest EPA cancer hazard classification unless the agency finds a causal relationship between exposure and cancer based on epidemiological evidence. Under the newer versions of the guidelines, however, such a finding is not required, and a highest level hazard categorization may be based more loosely on a "weight of the evidence" approach, i.e., on some combination of epidemiological and mechanistic data. EPA has never explained why such a change in policy was warranted.

The fact that the agency has failed to explain its rationale for changing its position on cancer hazard characterization away from the 1986 guidelines is borne out vividly by the recent words of its own scientists. In the draft report on dioxin released March 13, 2001, the SAB subcommittee stated:

Some of the uncertainty in the Subcommittee on the issue of what constitutes a definite human carcinogen arises from the fact that the Agency has not explained why it shifted from the position in the 1986 Cancer Risk Assessment Guidelines to that in the proposed 1999⁷ Guideline revisions. The 1986 Guidelines requires [sic] decisive evidence in humans and animals to categorize an agent as a definite human carcinogen. The proposed Guidelines accept suggestive human evidence, coupled with decisive animal evidence, to assign an agent to the "definite human carcinogen category." It would clarify the issue considerably if the rationale for this change was made clear by the agency.

SAB Executive Committee Review Draft, March 12, 2001 (Exh. 1 hereto) at 49 (emphasis added.)

Because EPA has failed to provide any adequate explanation for the change in its cancer assessment policy away from the procedures set forth in the 1986 guidelines, the Court should find EPA’s use of the later guidelines arbitrary and capricious.

C. EPA is Applying the Cancer Guidelines in an Arbitrary and Capricious Manner.

Plaintiffs do not dispute that the agency is entitled to substantial deference in evaluating the carcinogenic properties of various substances, provided that such evaluations are conducted pursuant to a single, properly adopted set of rules. Such scientific determinations are rightly left to the expertise and sound discretion of the agency. It is another thing altogether, however, to claim that the agency is free to apply divergent sets of rules to various substances in making these determinations. EPA’s ad hoc and unpredictable use of multiple and inconsistent cancer classification guidelines, as evidenced by the agency’s own "menu" approach to the pyrethrins assessment (see Compl. Exh. 1 at 2-6), represents the epitome of arbitrary and capricious agency action.

Defendants emphasize EPA statements in the Federal Register, following publication of the 1996 proposed guidelines, in which the agency asserted its right to disregard the previously adopted 1986 rules and to make carcinogen assessments on a "case-by-case" basis. If, by reading these statements and EPA’s cancer risk assessment rules, however, affected parties are not able to determine, with "ascertainable certainty", EPA’s processes for making carcinogen assessments, then the agency has failed to provide proper notice. See General Elec. Co. v. EPA, 53 F.3d 1324, 1329 (D.C. Cir. 1995) (agency has "fairly noticed" its interpretation where "a regulated party acting in good faith would be able to identify, with ‘ascertainable certainty,’ the standards with which the agency expects parties to conform"). The absence of a reasoned basis for decision making is, by definition, arbitrary and capricious agency action.

The EPA Federal Register statements Defendants cite merely indicate that EPA will continue to develop and revise its cancer guidelines, and that the agency will decide which principles to apply on a case-by-case basis. Such statements are not sufficient to notify the public of what cancer assessment rules the agency, in fact, is using or intends to use for a given assessment. In a case similar to the one before the Court, where petitioners challenged a rule ostensibly allowing EPA "to formulate alternative [air emission] limits on a case-by-case basis", the D.C. Circuit cautioned:

As we have stated before, general notice that a new standard will be adopted affords the parties scant opportunity for comment. The agency’s obligation is more demanding -- it must "describe the range of alternatives being considered with reasonable specificity. Otherwise, interested parties will not know what to comment on, and notice will not lead to better-informed agency decision-making."

Horsehead Resource Dev. Co. v. Browner, 16 F.3d 1246, 1266, 1268 (D.C. Cir. 1994) (quoting Small Refiner Lead Phase-Down Task Force v. EPA, 705 F.2d 506, 549 (D.C. Cir. 1983)). In Horsehead Dev. Co., the court went on to vacate EPA’s Tier III standard because "EPA simply failed to give interested parties sufficient notice of the form the standard might take" and the rule was not "a logical outgrowth of any precursor proposal." Id. at 1268-69.

EPA’s perfunctory explanation that the 1996 cancer guidelines "will be applied in part or in whole, on a case-by-case basis" (Def. Mem. at 4) (quoting 61 Fed. Reg. at 32,801 (June 25, 1996)), fails to explain how or why the agency intends to apply the new guidelines in some cases but not in others. "A long line of precedent has established that an agency action is arbitrary when the agency offer[s] insufficient reasons for treating similar situations differently." County of Los Angeles v. Shalala, 192 F.3d 1005, 1022 (D.C. Cir. 1999) (quoting Transactive Corp. v. United States, 91 F.3d 232, 237 (D.C. Cir.1996)); see also Motor Vehicle Mfrs., supra, 463 U.S. at 57; Airmark Corp. v. FAA, 758 F.2d 685, 691-92 (D.C. Cir.1985); Local 777, Democratic Union Org. Comm. v. NLRB, 603 F.2d 862, 872 (D.C. Cir.1978).

In County of Los Angeles v. Shalala, hospitals seeking adjustments to Medicare payments claimed that the Secretary of Health and Human Services had acted arbitrarily and capriciously when she calculated outlier thresholds for the years 1985-1986 using a 1981 data file, instead of an alternative 1984 data file, without explaining her decision adequately. Id., 192 F.3d at 1020. In rejecting the agency’s assertion that its cursory statement in the Federal Register had provided a sufficient explanation of the agency’s disparate payment methodology, the D.C. Circuit concluded:

In sum, the Secretary has inadequately explained why the 1984 data were suitable for one significant calculation but unreliable for another.
* * *

The Secretary's proffered distinction is thus not reasonable. She may in her discretion, of course, rely on preliminary data to make an across-the-board adjustment to variables that ordinarily are determined on a case-by-case basis. But when she does so, she must be prepared to explain why she cannot also use that data to make a similar adjustment to variables that are also typically calculated on an individual basis. As broad as her discretion is, it "is not a license to . . . treat like cases differently."

Id. at 1023 (citations omitted) (emphasis added).

A legal analogy outside the science policy context is illustrative. If an issue arose as to whether a plaintiff had brought a case within a two-year statute of limitations, a court would be well within its discretion to decide when the claim arose, when the plaintiff had notice of the claim, and other relevant factual issues. The court would not, however, be free to apply a one-year or a four-year statute of limitations on a "case-by-case basis". Such sweeping authority is nevertheless what EPA has asserted in its Federal Register statements.

EPA’s Federal Register assurances that it will "use the most scientifically appropriate interpretation" also does not insulate the agency from a claim of arbitrariness if its actions are taken without adequate explanation. "A judicial disposition to accord an administrative agency wide latitude in adjusting its regulatory policies from case to case does not dispense with the necessity of adequate explication of the reasons why such alteration or adaptation may be seen to be rational and to escape the domain of the seemingly arbitrary." FTC v. Crowther 430 F.2d 510, 514 (D.C. Cir. 1970) (noting that absent such a requirement, "Judicial review of agency action otherwise becomes meaningless and incapable of fulfilling the Congressional purposes in providing it.")

Here, the Federal Register statements Defendants cite do not explain what criteria the agency will use in deciding whether to apply the 1996 proposed guidelines -- let alone the 1999 draft guidelines, which have never even been published in the Federal Register

-- instead of the final and still effective 1986 cancer guidelines. Affected parties thus have no way of knowing in advance the scientific principles the agency will employ in evaluating the parties’ pesticide products or any other allegedly carcinogenic substance.

There is even some indication that the agency itself does not know which set of guidelines it will apply in a given context. As the recent statement from the SAB dioxin subcommittee demonstrates (see p. 22 & n. 7, supra), the agency’s own scientists are uncertain which of the newer guidelines -- 1996 or 1999 -- are to be applied during the dioxin reassessment.⁸ Given this state of affairs, there is every indication that the guidelines are being applied in an arbitrary and capricious manner.

IV. Both the Dioxin and the Pyrethrins Plaintiffs Have Standing.

Applicable case precedent clearly supports the standing of Plaintiffs in this case. As an initial matter, the Court must accept as true all material allegations of a petition for review, and it will suffice if these allegations show that the party seeking review has standing. See, e.g., Village of Arlington Heights v. Metropolitan Development Corp., 429 U.S. 552, 264 n. 9 (1977); Block v. Meese, 793 F.2d 1303, 1307 (D.C. Cir.) (holding distributor of foreign film classified as "political propaganda" by Department of Justice had standing to challenge classification in view of assertion that potential customers would not purchase film), cert. denied, 478 U.S. 1021 (1986).

In addition, the threatened harm to plaintiffs as a result of public reaction to the EPA reports need not be great. In cases where the harm is visited on the plaintiff through acts of third parties, the question "usually turns on a determination of ‘how likely it is that the third party’s response to the challenged governmental action will injure the plaintiff at all’". Natural Resources Defense Council v. Jamison, 787 F. Supp. 231, 234 (D.D.C. 1990) (holding environmental group had standing to challenge rules affecting leasing and mining of federally owned coal) (emphasis in original) (quoting Wilderness Soc’y v. Griles, 824 F.2d 4, 12 (D.C. Cir. 1987)).

Moreover, Defendants must refute the standing of all Plaintiffs, including Tozzi, Diatect and Brevet, in order to prevail on their standing argument. Once the Court concludes that any one Plaintiff has standing, the Court need not engage in a separate standing analysis with respect to other Plaintiffs. Watt v. Energy Action Educ. Found., 454 U.S. 151, 160 (1981). As discussed below, it is clear that both Plaintiff Brevet and Plaintiff Diatect have standing sufficient to support jurisdiction.

A. Brevet Has Standing to Challenge the Final Dioxin Reassessment.

Plaintiff Brevet manufactures disposable plastic connectors for use with polyvinyl chloride ("PVC") tubing and surgical units used during open-heart surgery and other medical procedures. The imminent release of the dioxin reassessment threatens Brevet’s ability to continue manufacturing and marketing its medical equipment products. As noted above and in Plaintiffs’ application for preliminary injunction, Judge Emmet Sullivan recently ruled that Brevet had standing to challenge a similar federal agency report regarding the alleged carcinogenicity of dioxin. Tozzi v. DHHS, Civ. No. 99-1170 (D.D.C. Sept. 30, 2000). If Brevet does not have standing to challenge the issuance of the EPA dioxin reassessment, then arguably no one does.⁹

1. Injury-in-Fact

For purposes of satisfying the injury prong of the standing analysis, it is enough for plaintiffs to support, by affidavit, a "reasonable concern" of harm. Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S. 167, 169 (2000). The irreparable harm Brevet faces from release of the draft dioxin reassessment as final is addressed in detail in Plaintiffs’ application for preliminary injunction at pp. 28-32, and that discussion is incorporated herein. Even if the Court were to conclude that the threat of irreparable harm to Brevet did not support the preliminary injunction plaintiffs seek, there can be no doubt that the affidavit of Charles Brewer demonstrates a reasonable concern of harm. In summary, and for purposes of the standing analysis, Brevet has a reasonable concern that the dioxin reassessment will result in harm, based on the following facts:

• Over 95 percent of Brevet’s sales depend upon the continued use of flexible PVC tubing in the medical equipment industry.
• The dioxin reassessment specifically cites "medical wastes" and PVC manufacturing as sources of dioxin releases and concludes that dioxin, at current background levels, is ten times more likely to cause cancer than previously had been thought.
• Vocal activist groups have cited government findings on dioxin in the past and are poised to trumpet the proposed dioxin reassessment as part of their campaign to eliminate PVC use.
• Citing previous EPA findings, municipal resolutions in Brevet’s home state have called for the "phase-out" of PVC medical products.
• Brevet has already lost customers due to concerns over the alleged link between PVC and environmental dioxin levels.¹⁰

On February 5, 2001, a week after Plaintiffs filed their last brief, the Stop Dioxin Exposure Campaign transmitted a letter to President Bush urging him to release the dioxin reassessment as final in its current form. The letter, which was signed by over 400 organizations, is further evidence in support of Plaintiff Brevet’s reasonable concern. See Exhibit 4 hereto (letter and press release issued same day). Citing statements by Dr. William Farland, Director of EPA’s National Center for Environmental Assessment, the letter also confirms that EPA is poised to release a "Cross-Media Dioxin Strategy" in March. The letter reiterates the dioxin draft reassessment’s conclusions that (i) EPA considers dioxin to be "carcinogenic to humans", and (ii) "The risk of getting cancer from dioxin is 10 times higher than reported in 1994." The letter also specifically identifies medical waste as a leading source of dioxin.

2. Causation

Defendants claim that Plaintiffs have failed to satisfy the causation prong of the standing analysis, emphasizing that neither the dioxin reassessment nor the 1999 Final Report on pyrethrins directly imposes a regulatory burden on Plaintiffs. The fact that harm to Brevet and Diatect will result from the actions of third parties, however, does not defeat standing. National Wildlife Federation v. Hodel, 839 F.2d 694, 705 (D.C. Cir. 1988) ("mere indirectness of causation is no barrier to standing, and thus, an injury worked on one party by another through a third party intermediary may suffice"). As the D.C. Circuit has further stated, "We are concerned here not with the length of the chain of causation, but on [sic] the plausibility of the links that comprise the chain." Public Citizen v. Lockheed Aircraft Corporation, 565 F.2d 708, 717 n. 31 (D.C. Cir. 1977).

Here it is not only "plausible" that Plaintiff Brevet will suffer adverse economic consequences from publication of the draft dioxin reassessment as final, but virtually inevitable. The dioxin reassessment unmistakably links the Plaintiffs’ products with an increased risk of cancer. The report will thus be perceived by the public, as well as vocal opponents of Brevet’s products, as scientific confirmation of those alleged risks. This linkage is more than sufficient to demonstrate causation for purposes of the standing analysis. Blum v. Yaretsky, 457 U.S. 991, 1001 (1982); Block v. Meese, supra, 793 F.2d at 1309; National Comm. to Preserve Social Security v. Bowen, 735 F. Supp. 1069, 1081 (D.D.C. 1990) (holding presence of intermediary in causation chain insufficient to deny standing); SOCMA, supra, 720 F. Supp. at 1248; see also Dow Chem., supra, 459 F. Supp. at 393 (enjoining release of interim regulations classifying plaintiffs’ consumer product as suspected carcinogen where agency action "will result in substantial loss of business for the plaintiffs"). Moreover, as Brevet’s president noted in his affidavit, Brevet is entirely dependent on the continued manufacture of PVC products.

3. Redressability

Plaintiffs do not dispute the familiar language on redressability that Defendants cite from Lujan v. Defenders of Wildlife, 504 U.S. 555, 561 (1992), and Florida Audubon Soc’y v. Bentsen, 94 F.3d 658, 663-64 (D.C. Cir. 1996). Def. Mem. at 31. Defendants grossly distort the record, however, in applying these principles to Plaintiff Brevet.

Defendants’ brazen assertion that the 1985 risk assessment for dioxin "includes the same type of statements and conclusions regarding dioxin that Plaintiffs now seek to keep from the public" (Def. Mem. at 32) ignores the alarming -- and new -- conclusions that EPA is poised to announce. The draft dioxin reassessment EPA is threatening to publish as final states that (i) dioxin is a "human carcinogen" (not a "probable" human carcinogen, as the 1985 assessment concluded), and (ii) the risk of cancer from environmental dioxin exposure is ten times greater than had been previously projected. See, e.g., C. Skrzycki, Washington Post (May 17, 2000) P.I. Appl. Exh. B. To assert that an order from the Court barring the agency’s release of such inflammatory statements would have no positive effect on Brevet’s ongoing struggle with anti-PVC activists ignores the obvious.

The "other sources" on dioxin risk that Defendants cite (Def. Mem. at 31) do not carry the same weight with the public as would a final determination, capping a decade-long study, by the federal government’s foremost environmental agency. The California regulations Defendants cite are the product of a state, not a federal, body, and have far less influence nationally than would EPA’s dioxin reassessment. The only other "source" of information on dioxin "risks" that Defendants cite, the 9^th Report on Carcinogens, is not even a risk-based document. Moreover, the controversial findings on dioxin in that report are still in litigation. The Court need only examine the February 5, 2001 letter to President Bush from the Stop Dioxin Exposure Campaign (Exh. 4 hereto) to understand the prominence of the EPA dioxin reassessment among all studies in the field.

B. Plaintiff Diatect Has Standing to Challenge the 1999 Final Report on Pyrethrins.

1. Injury-in-Fact

Plaintiff Diatect faces the threat of severe economic harm as a direct result of the 1999 Final Report. As discussed in the affidavit of Diatect’s President, George H. ("Herb") Henderson (attached as Exhibit 5), the widespread publication of EPA’s "false and misleading" 1999 Final Report could be ruinous to the company. Id. at ¶ 3. All of Diatect’s products contain pyrethrins, and Diatect has staked its entire corporate future on the continued marketability of these products as safe. Id. at ¶ 12. The Final Report puts that marketability at significant risk.

The Final Report is particularly threatening at this moment in Diatect’s operations. Over the past several months, the company has embarked on a major new marketing campaign for two of its pyrethrin-based products. Diatect has made substantial investment in these programs, both in time and money, and is counting on customer acceptance of its products in new geographic markets. Id. at ¶ 9. The Final Report seriously threatens the success of these initiatives, as well as the continued viability of all the company’s products.

2. Causation

Diatect also satisfies the causation prong for standing. Diatect targets niche markets in the home and garden and agribusiness pesticide industries. Id. at ¶ 5. Customers in these markets are highly sensitive to product safety issues, including any perceived threats to the environment or human health. Id. Thus, if EPA’s Final Report is not retracted or substantially revised, the report will have serious and unjustified adverse effects on Diatect. Id. at ¶ 3.

Defendants claim that the 1999 Final Report on pyrethrins could not "cause" the threatened harm that Diatect foresees because the 1999 report merely confirmed previous agency conclusions the agency had reached in 1995. Specifically, Defendants assert (Def. Mem. at 30) that the 1999 Final Report, which was based on the 1996 proposed cancer guidelines, and the agency’s 1995 pyrethrins findings, which were based on the 1986 guidelines, "reached essentially the same conclusion." This statement is demonstrably false.

The agency’s conclusions in 1995 related to sufficient evidence of carcinogenic activity in laboratory animals. Nothing in the 1995 report raised the alarming specter of pyrethrins being likely to cause cancer in humans. Only through the agency’s application of new default principles contained in the non-finalized 1996 proposed guidelines was EPA able to conclude that pyrethrins were "likely to be a human carcinogen by the oral route." Compl. Exh. 2 at vi (handwritten page "9"). Then, based on that conclusion, EPA went on to state, "Since there are no carcinogenicity studies by other routes of exposure, pyrethrins are assumed to be carcinogenic by these other routes." Id.

Defendants misquote the record in support of their "same conclusion" claim, asserting that in 1995 the agency had found "sufficient evidence of carcinogenicity". Def. Mem. at 30. The summary of the 1995 findings, as set forth in the 1999 Final Report, however, actually states: "There was sufficient evidence of carcinogenic activity...", but that the Committee was "unable to classify pyrethrins for carcinogenicity". Compl. Exh. 2 at iv (emphasis added). The distinction between "carcinogenicity" and "carcinogenic activity" is significant because the latter may also include common pre-cancerous markers that may or may not ultimately lead to cancer. There certainly is nothing in the 1995 report indicating that EPA had concluded that pyrethrins are "likely" carcinogens, let alone likely human carcinogens.

Relying on the non-finalized 1996 cancer guidelines, the agency thus has reached a conclusion regarding the carcinogenicity of pyrethrins that is dramatically more inflammatory than any previous EPA statements, including those in the 1995 report. The Court should reject the agency’s disingenuous attempt to whitewash the contrast between the two reports.

Thus, as with Plaintiff Brevet, it is not merely "plausible", but very likely, that

Diatect will suffer adverse economic consequences as a result of the EPA report at issue. The 1999 Final Report unmistakably, if erroneously, links Diatect’s products with an increased risk of cancer in humans. The report will be perceived and publicized by pesticide watchdog groups -- indeed, this already has occurred to some extent (see Compl. Exhs. 3, 4) -- as confirmation of the alleged risks from pyrethrins use. Finally, like Brevet, Diatect is entirely dependent on the public’s acceptance of it products and is highly vulnerably to changes in public attitude. See, e.g., Blum v. Yaretsky, supra, 457 U.S. at 1001; Block v. Meese, supra, 793 F.2d at 1309; National Comm. to Preserve Social Security, supra, 735 F. Supp. at 1081; SOCMA, supra, 720 F. Supp. at 1248; Dow Chem., supra, 459 F. Supp. at 393.

3. Redressability

Defendants claim that "Diatect's fears regarding actions of third parties would not be addressed by removing only one of two CPRC reports." Def. Mem. at 32. As discussed above, the 1995 report is not the source of the harm to Diatect, and Defendants’ argument concerning redressability therefore misses the mark entirely. The Court clearly has authority to issue an order directing EPA to withdraw the 1999 Final Report, and that order will redress the harm to Diatect that Plaintiffs have alleged.

The Congressional Review Act, 5 U.S.C. § 801, et seq. ("CRA"), required EPA to submit the 1996 and 1999 cancer guidelines to Congress and the Comptroller General for review, prior to using those guidelines as a basis for the dioxin reassessment or the 1999 Final Report on pyrethrins. See P.I. App. at 23-28. EPA failed to finalize and submit either of the new rules to Congress and the Comptroller General as required, however. The Court should therefore declare that the 1996 and 1999 cancer guidelines cannot be given effect.

As Plaintiffs correctly anticipated in their application for preliminary injunction, Defendants argue that the CRA is not judicially enforceable, based on the partial bar to reviewability set forth in CRA section 805. Significantly, Defendants make no attempt to argue that EPA has, in fact, complied with the CRA. Rather, Defendants’ entire defense rests on the assertion that the CRA -- in its entirety -- is beyond review and enforcement by this Court. Plaintiffs already have responded to this facial challenge at pp. 25-28 of the memorandum in support of their application for preliminary injunction. For the convenience of the Court, that text is reproduced immediately below:

Plaintiffs anticipate that Defendants will cite a provision of the Congressional Review Act in support of an argument that the statute is simply not reviewable by this Court. Section 805 of the CRA provides:

No determination, finding, action, or omission under this chapter shall be subject to judicial review.

5 U.S.C. § 805.

Section 805, at first appearance an absolute bar to all judicial review under the CRA, must be read in the context of the entire Congressional Review Act. Established principles of statutory construction dictate that a court must, whenever possible, give effect to all a statute’s provisions. See, e.g., Mountain States Tel. & Tel. Co. v. Pueblo of Santa Ana, 472 U.S. 237, 249 (1985) (statute should be interpreted so as not to render one provision redundant); Edison Elec. Inst. v. EPA, 996 F.326 (D.C. Cir. 1993) ("The problem with this interpretation is that it effectively reads fifteen words . . . out of section 3004(j)"); Vymetalik v. FBI, 785 F.2d 1090, 1096 (D.C. Cir. 1986).

Here, if section 805 were read to preclude all judicial review, then section 801(a) would be rendered completely meaningless. Agencies could utilize rules against private parties to the same extent as before passage of the CRA, even if such rules had not "take[n] effect". Without at least some judicial role, the statute would become a total nullity. See Leedom v. Kyne, 358 U.S. 184, 189-90 (1958) (allowing judicial review where "‘absence of jurisdiction of the federal courts’ would mean ‘a sacrifice or obliteration of a right which Congress has given professional employees, for there is no other means within their control . . . to protect and enforce that right"). In the case at hand, the draft guidelines are without effect by operation of law, through a plainly worded congressional mandate that constitutes a limitation on the agency's delegated authority. Strictly speaking, there is nothing for the court to "review"; rather, the court must simply recognize and give effect to that plain congressional mandate.

In order to reconcile section 801 and section 803, it is therefore appropriate for the Court to examine the legislative history behind the CRA. Florida Power & Light Co. v. Lorion, 470 U.S. 729, 737 (1985) ("Because we find the statute ambiguous on its face, we seek guidance in the statutory structure [and] relevant legislative history. . .").

The legislative history of the Congressional Review Act makes unmistakably clear that the statute does not preclude the judicial review sought here. The Joint Explanatory Statement of H.R. 3136 in the Congressional Record clarifies that Congress did not intend section 805 to preclude adjudication of whether a rule is "in effect". While the report makes clear that certain provisions of the law are beyond the reach of courts (e.g., compliance by Congress with procedures set forth in the statute and determinations by the Office of Management and Budget as to whether a rule is a "major rule"), the statute does not preclude the kind of review Plaintiffs seek:

The limitation on judicial review in no way prohibits a court from determining whether a rule is in effect. For example, the authors expect that a court might recognize that a rule has no legal effect due to the operation of subsections 801(a)(1)(A) or 801(a)(3).

143 Cong. Rec. S3686, (April 18, 1996) (Statements by Senators Nickles, Reid and Stevens); see also 143 Cong. Rec. E577 (April 19, 1996) (Statements by Rep. Hyde). The relevant excerpts from the Congressional Record are attached at [P.I. Appl.] Exh. K.

Significantly, Senator Nickles was an author of the congressional review subtitle and a co-sponsor of S. 219, the Senate forerunner of the final bill. Id. at S3683. The legislation that unanimously passed the Senate in 1996 (S. 942) was similar to the original version of S. 219, which Senator Nickles had co-sponsored the year before. Id. at S3684. The Supreme Court has held that the remarks of a sponsoring Senator "are an authoritative guide to the statute’s construction." North Haven Bd. of Educ. v. Bell, 456 U.S. 512, 526-27 (1982). Congressman Hyde was the primary author/sponsor of the bill in the House, as Senator Nickles was in the Senate.

In the face of clear and authoritative legislative history to the contrary, any claim that section 805 bars judicial review of EPA’s compliance with the Congressional Review Act must necessarily fail. The Court thus has ample jurisdiction to issue a ruling that the 1996 and 1999 cancer guidelines have not "take[n] effect" and therefore cannot be used as a basis for the dioxin reassessment or other agency decision making.

For the foregoing reasons, Defendants’ motion to dismiss should be denied.

Respectfully submitted, ________________________________ Charles J. Fromm DC Bar No. 420021 Multinational Legal Services, PLLC 11 Dupont Circle, Suite 700 Washington, DC 20036 Ph: (202) 797-7124 Fax: (202) 939-6969 Attorneys for Plaintiffs

Dated: March 22, 2001