> Motion to Dismiss > Memorandum in Support of

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA

MOTION TO DISMISS FOR LACK
OF JURISDICTION

   Defendants United States Environmental Protection Agency, et al., ("EPA") hereby move pursuant to Fed. R. Civ. P. 12(b)(1) to dismiss the Complaint filed on October 27, 2000, by Plaintiffs Jim J. Tozzi ("Tozzi"), Diatect International Corp. ("Diatect"), and Brevet Industries. And Brevet Inc. ("Brevet") for lack of jurisdiction. The grounds for this motion are:

1. Plaintiffs seek review of two instances of EPA's use of the cancer risk assessment guidelines under the APA. Specifically, Plaintiffs challenge EPA's 1999 cancer reassessment for the pesticide pyrethins and EPA's not yet completed risk reassessment for dioxin on the basis that EPA used updated techniques for assessing the carcinogenic potential of the chemicals, rather than using the methods set forth as guidance in EPA's 1986 Guidelines for Carcinogenic Risk Assessment.
   
   
2. This Court lacks jurisdiction to review the pyrethins and dioxin risk assessments under the Administrative Procedure Act, 5 U.S.C. § 704, because these reassessments are not final agency action. They do not reflect the consummation of EPA's regulatory decision-making processess and do not affect the rights and obligations of Plaintiffs.
   
   
3.  Plaintiffs have not alleged that EPA's risk reassessments for pyrethins or dioxin suffer from any scientific or other substantive flaw. Instead Plaintiffs erroneously claim that guidelines published by EPA in 1986 for conducting cancer risk assessments are a regulation that EPA must follow until it amends those guidelines through a notice-and-comment rulemaking proceeding. Because the Guidelines are not a regulation, this case should be dismissed for failure to state a claim upon which relief can be granted.
   
   
4. Further, all of the plaintiffs lack standing to bring this action since none of the plaintiffs can demonstrate the three critical elements of standing: injury-in-fact, causation or redressability.
   
   
5. Finally, Plaintiffs claim that EPA violated the Congressional Review Act, ("CRA") 5 U.S.C. 801, et seq., by not submitting the1996 and 1999 proposed revised cancer guidelines to Congress, the CRA itself states that actions or omissions under that Act are not subject to judicial review.
   
   
6. For these reasons, and for the reasons set forth in the accompanying Memorandum Of Points And Authorities In Support Of Motion To Dismiss For Lack Of Jurisdiction, the Court should dismiss Plaintiffs' Complaint.
   
   

Of Counsel:

Roland Dubois
Jonathan Fleuchaus

DEFENDANTS' MEMORANDUM IN SUPPORT OF
MOTION TO DISMISS THE COMPLAINT

INTRODUCTION

   Pursuant to Fed. R. Civ. P. 12(b)(1) and 12(b)(6), Defendants Environmental Protection Agency, et al., ("EPA") hereby move to dismiss the challenge of Plaintiffs Jim J. Tozzi ("Tozzi"), Diatect International Corp. ("Diatect"), and Brevet Industries and Brevet Inc. ("Brevet") to EPA's 1999 cancer reassessment for the pesticide pyrethins and EPA's not yet completed risk reassessment for dioxin. Both the challenged actions are just interim steps in ongoing agency processes. EPA's risk reassessments for pyrethins and dioxin are not "final agency action" so as to be reviewable under the Administrative Procedure Act ("APA"), 5 U.S.C. § 706. Accordingly, the Court lacks jurisdiction over Plaintiffs' claims. Plaintiffs challenge these actions on the basis that EPA used updated scientific techniques for assessing the carcinogenic potential of the chemicals, rather than using the methods set forth as guidance in EPA's 1986 Guidelines for Carcinogen Risk Assessment. Plaintiffs have not alleged that EPA's risk reassessments for pyrethrins or dioxin suffer from any scientific or other substantive flaw. Instead, their entire Complaint is based on an erroneous procedural claim -- that guidelines published by EPA in 1986 for conducting cancer risk assessments are a regulation that EPA must follow until it amends those guidelines through a notice-and-comment rulemaking proceeding. On their face, the 1986 guidelines disprove this claim. Therefore, this case should be dismissed for failure to state a claim upon which relief may be granted. Dismissal is also warranted because Plaintiffs lack standing; and because Plaintiffs' claim under the Congressional Review Act, 5 U.S.C. 801 et seq. is barred by the express terms of that statute. Accordingly, EPA's motion to dismiss should be granted.

BACKGROUND

   EPA is directed under various statutes to carry out activities (such as issuing regulations and licenses) that address the levels of chemicals that may be present in the environment or on agricultural commodities taking into consideration possible effects on human health and the environment. Ancillary to any regulatory activity, EPA scientists review and analyze the available scientific information on chemicals of concern to human health or the environment, and summarize their findings in documents of varying scope. The scientists' findings may be summarized in comprehensive "risk assessments" that address all information available on every possible impact that a chemical may have on human health (e.g., cancer, reproductive toxicity, developmental toxicity, allergenic reactions, etc.) and the environment (e.g., effects on wildlife, aquatic life, plants), and which set forth estimates of the risk of adverse effects associated with various levels of exposure to the chemical. At times, however, EPA scientists may prepare a more limited partial risk assessment that analyzes only a particular aspect of risk such as whether or not it appears possible that exposure to a chemical could cause cancer or some other adverse health effect. Risk assessments are not rules, and may be used, revised, or deemed irrelevant in any regulatory proceeding.

   The ability of chemicals to cause cancer in humans is one of the many possible impacts on human health that EPA analyzes. Because new concepts and techniques of assessing carcinogenic potential are continually being developed, EPA scientists periodically review the emerging science and provide guidance to others within the agency on advances in this discipline. EPA's first such guidance was developed in 1976. 41 Fed. Reg. 21,402 (May 25, 1976). Various "proposed" and "final" revisions to this guidance, entitled "Guidelines for Carcinogen Risk Assessment" were released in 1984, 1986, 1996 and 1999 (collectively referred to as "cancer risk assessment guidelines" or "cancer guidelines"). 49 Fed. Reg. 46,294 (Nov. 23, 1984); 51 Fed. Reg. 33,992. (Sept. 24, 1986); 61 Fed. Reg. 17,960 (April 23, 1996); Guidelines for Carcinogenic Risk Assessment, July 1999 Review Draft, available at https://www.epa.gov/ncea/raf/crasab.htm.

   EPA's cancer guidelines provide guidance to EPA scientists on conducting qualitative cancer assessments (i.e., analyses of the likelihood, expressed in words such as "probable", "likely" or "known," that exposure to a substance could cause cancer) and quantitative cancer risk assessments (i.e., analyses of the likelihood, expressed numerically, that a chemical will cause cancer under existing or expected exposure levels). These documents provide guidance only "in general terms", because "the science of carcinogenesis is in a state of rapid advancement, and overly specific approaches may rapidly become obsolete." 51 Fed. Reg. 33, 993 (Sept. 24, 1986). As stated in the Federal Register introduction to the "final" 1986 guidelines:

Id. at 33,992. In issuing the 1986 cancer guidelines, the EPA Administrator certified that the guidelines were not major rules as defined by Executive Order 12291, "because they are non- binding policy statements and have no direct effect on the regulated community." Id. at 33,992. EPA reaffirmed the non-binding nature of the 1986 cancer guidelines when it stated, soon after publication of the 1996 proposed revised cancer guidelines, that:

61 Fed. Reg. 32,799, 32,801 (June 25, 1996).

   Cancer risk assessments, whether developed in accordance with the cancer guidelines or not, have no regulatory consequence in and of themselves. A regulatory action with respect to the chemical may follow quickly after preparation of a risk assessment, several years thereafter, or never at all. If a regulatory action is taken, the scientific evidence and analysis incorporated in the risk assessment will be only one part of the information that informs the EPA decision. EPA will also consider additional scientific information or methods and, after issuing a proposed regulation or draft permit, will review and consider any comments from the public or the regulated community on the validity or adequacy of the risk assessment and its proposed application, as well as on other relevant matters affecting EPA's ultimate decision. EPA licensing and permitting decisions typically may be appealed administratively, and in some cases such appeals may involve a full adjudicatory hearing. E.g., 7 U.S.C. §§ 136d(b),(d) and 136w(d). Only at the conclusion of the required rulemaking or adjudicatory process will EPA take a final action that may impose restrictions or bind regulated entities.

   Draft Dioxin Reassessment

   The term "dioxin" refers to a group of 30 compounds that share certain chemical structures and modes of action in exposed biological organisms. The term dioxin is also often used to refer to the most well-studied and toxic of the dioxin compounds, 2,3,7,8-tetrachlorodibenzo-p-dioxin (herein, "TCDD"). Many of the dioxins, including TCDD, are produced inadvertently by a number of human activities. Combustion, chlorine bleaching of pulp and paper, certain types of chemical manufacturing and processing, and other industrial processes all can create small quantities of dioxins.

   EPA's last comprehensive risk assessment of TCDD and certain of the other dioxins was completed in 1985. Health Assessment Document for Polychlorinated Dibenzo p-Dioxins, EPAl600/8-84/014F, September 1985. EPA found at that time that the weight of the evidence from human and animal studies and accidental exposures indicated that TCDD alone, and a mixture of a number of other dioxins, should be qualitatively characterized as "probable" human carcinogens. Id. at 2-8. EPA also conducted a quantitative cancer risk assessment of these compounds and determined that TCDD alone, and a mixture of other dioxins, were "the two most potent carcinogens [yet] evaluated" by EPA. Id. The dioxins were also found to demonstrate a range of non-cancer health effects on experimental animals, including lethal poisoning, immune system suppression, altered liver function, neurotoxicity, teratogenicity (fetal malformations), and fetotoxicity (fetal death). Id. at 2-4 to 2-5. In addition, EPA found that these compounds are resistant to degradation in soil and water, id. at 5-18, and that they tend to "bioconcentrate" in fish and other aquatic organisms at levels thousands of times higher than found in the ambient environment. Id. at 5-19,

   In April 1991, EPA initiated a scientific reassessment of dioxin health effects and exposures (the "dioxin reassessment"). EPA began this task in light of significant advances in scientific information regarding mechanisms of dioxin toxicity, significant new studies of dioxin's carcinogenic potential in humans and increased evidence of other adverse health effects. EPA released a draft of the dioxin reassessment in September, 1994, that totaled over 2,200 pages. EPA's Science Advisory Board ("SAB"), a statutory advisory committee, conducted a peer review of that draft and requested that EPA revise and re-submit for its review certain portions of the 1994 draft and update the entire draft to reflect the continually emerging science. EPA completed that effort in September; 2000, and the SAB is currently conducting a peer review of portions of the revised document. When the SAB's review is complete, EPA intends to incorporate any comments from the SAB and issue a revised, final dioxin reassessment.

   Among other advances, the draft dioxin reassessment addresses the risks associated with a greater number of dioxins than the 1985 risk assessment, and sets forth a mechanism for quantifying the cancer risk associated with human exposure to a mixture of dioxins. The latter aspect is particularly important because humans are invariably exposed to mixtures of dioxins, rather than to individual dioxin compounds. The most recent draft reassessment describes information implicating dioxin in causing cancer, reproductive and developmental effects, impairment of immune function, diabetes, heart disease, impaired thyroid function, and other adverse human effects. See EPA Office of Research and Development, Exposure and Human Health Reassessment of 2,3, 7,8-Tetrachlorodibenzo p-Dioxin (TCDD) and Related Compounds: Part Ill: Integrated Summary and Risk Characterization (September 2000 SAB Review Draft) at 19-49, available at https://www.epa gov/ncea/pdfs/dioxin Part 1 and 2 . htm. The draft document identifies TCDD as a "human carcinogen" and mixtures of dioxins as "likely" human carcinogens. Id. at 29-30, 103-107. It provides an updated quantitative analysis of the likelihood that cancer will result from exposure to varying doses of dioxin. Id. at 90-93. It also summarizes information on human exposures, including information indicating that all humans carry significant body burdens of dioxin, regardless of where they live; that human uptake of dioxin appears to occur principally through consumption of animal-derived food products such as milk, eggs, pork, beef and poultry; and that dioxin levels in the U.S. environment appear to be decreasing since the advent of environmental initiatives begun in the 1970's. See generally, id. at 68-76. The dioxin reassessment is focused on human health, and does not include an assessment of dioxin risks to aquatic life or wildlife.

   The final dioxin reassessment will be a scientific document, and will have no regulatory consequences per se. If and when EPA proposes to use the final dioxin reassessment as the basis for any future EPA regulatory action, 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.

   Pyrethrins Revised Risk Assessment

   The challenged revised risk assessment for pyrethrins is one preliminary step in EPA's currently ongoing evaluation of whether the federal regulatory approvals for this pesticide should be continued, modified or revoked. EPA regulates pesticides under both the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA"), 7 U.S.C. § 136 et seq., and section 408 of the Federal Food, Drug, and Cosmetic Act ("FFDCA"), 21 U.S.C. § 346a. FIFRA imposes a federal licensing scheme on pesticides.. Before a pesticide may be sold or distributed, it must be registered with EPA under FIFRA, 7 U.S.C. § 136a(a). Pyrethrins, which are concentrated alkaloid substances extracted from flowers of the family of plants known as chrysanthemums, have been registered under FIFRA for many years for use as insecticides. Under the FFDCA, EPA sets maximum allowable levels ("tolerances") for pesticide residues in foods. See 21 U.S.C. § 346a(a). Tolerances permitting pyrethrin residues in various foods have been established under the FFDCA. 40 C.F.R. § 180.128.

   EPA is currently under a statutory mandate to complete a reregistration process under FIFRA, and a tolerance reassessment process under FFDCA. In these processes, EPA must reevaluate whether pesticides that are registered under FIFRA or have tolerances under FFDCA meet the applicable standards under these laws. See 7 U.S.C. § 136a-1; 21 U.S.C. § 346a(q). A pesticide may not be registered under FIFRA unless EPA determines that "it will not generally cause unreasonable adverse effects on the environment." 7 U.S.C. § 136a(c)(5). "Unreasonable adverse effects on the environment" are defined to mean, in part, "any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide . . . ." 7 U.S.C. § 136(bb). Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance only if EPA determines that the tolerance is "safe." 21 U.S.C. § 346a(b)(2)(A)(i). Section 408(b)(2)(A)(ii) defines "safe" to mean that "there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information." 21 U.S.C. § 346a(b)(2)(A)(ii).

   One of the key components of the reregistration and tolerance reassessment determinations regarding "unreasonable risk" and "safety" is the completion of an up-to-date and comprehensive risk assessment. As a preliminary step in such a risk assessment, EPA identifies all potential toxic effects, or endpoints, that may be associated with exposure to the pesticide, including, but certainly not limited to, carcinogenicity. In examining whether a pesticide may cause cancer, EPA first has its staff scientist review pertinent scientific data and prepare detailed data evaluation memoranda. These data reviews are then considered in an internal peer review process by the Cancer Peer Review Committee ("CPRC") in the Health Effects Division of EPA's Office of Pesticide Programs. The report prepared by the CPRC generally includes a recommendation as to whether a quantitative cancer risk assessment should be performed as well as a cancer classification (e.g., classifying the pesticide as a "likely human carcinogen"). As new information becomes available, CPRC reports are updated or reevaluated as necessary. CPRC reports are considered by EPA scientists, along with information on a pesticide's other toxic endpoints and exposure, in conducting a quantitative risk assessment, including a quantitative cancer risk assessment, if appropriate, for a pesticide. In turn, these risk assessments and the underlying scientific and factual conclusions are considered, among other things, by EPA in making reregistration, reassessment, and other regulatory decisions. At any stage in the process, EPA retains the discretion to modify its risk assessments or decision-making to take into account new information or better science. If the reregistration or reassessment efforts lead EPA to undertake to cancel or suspend a FIFRA registration or to revoke or modify a FFDCA tolerance, affected parties are entitled to both administrative and judicial review of the EPA action. See 7 U.S.C. § 136d; 21 U.S.C. § 346a(g) and (h).

   Currently, pyrethrins are in the midst of the FIFRA reregistration and FFDCA tolerance reassessment processes. EPA has taken some preliminary steps toward conducting an up-do-date risk assessment for pyrethrins but further data collection and evaluation is necessary before completion of the risk assessment. One of the preliminary steps undertaken involves the assessment of pyrethrins carcinogenic potential. Two CPRC reviews have been held on this question.

   In 1995, the CPRC concluded that there was "sufficient evidence of carcinogenicity" based "principally on thyroid tumors in male and female rats" but was "unable to classify pyrethrins for carcinogenicity because of questionable accuracy of the histopathological evaluation for several tissue types." Office of Pesticide Programs, Cancer Assessment Document: Evaluation of the Carcinogenic Potential of Pvrethrins, iv (April 1999). Nonetheless, the CPRC thought a quantitative cancer risk assessment was appropriate because it recommended using "the linear low dose extrapolation model for carcinogenic risk assessment, based on combined thyroid follicular cell adenomas and carcinomas in female rats." Id. In 1999, the CPRC revisited the question of pyrethrins' carcinogenicity. Taking into account additional data and a pathology peer review submitted by the Pyrethrins Joint Venture, a group comprised of the major pyrethrin FIFRA registrants, the CPRC, in 1999, concluded that pyrethrins should be classified as "likely to be a human carcinogen by the oral route" based on evidence of liver and thyroid tumors in rats. Id. at 20. It is this revised 1999 CPRC report that Plantiffs challenge.

   In response to the 1999 CPRC report, the Pyrethrins Joint Venture submitted a letter to EPA arguing that the CPRC had misapprehended the importance of data showing benign liver tumors and suggesting that the thyroid tumor data was likely to have little toxicological significance due to the toxicological mechanism of action of pyrethrins in the thyroid. Letter from Thomas G. Osimitz, Pyrethrin Joint Venture Committee, to Barry O'Keefe, Office of Pesticide Programs regarding EPA Cancer Assessment of Pyrethrins 2 (December 15, 1999). On this latter point, the Pyrethrins Joint Venture noted that it was proceeding with studies on the mechanism of toxicity for pyrethrins in the thyroid and it requested that "the Agency prepare to reassess the cancer potential of pyrethrins as soon as possible after the PJV submits new mechanistic and other relevant data." Id. at 3. EPA understands that such mechanistic data are being produced and EPA will evaluate such data when submitted.

   In its pesticide reregistration and tolerance reassessment review process for pyrethrins, EPA has not progressed beyond its evaluation of the potential of pyrethrins to cause cancer. EPA has not conducted a quantitative risk assessment of the potential cancer risk posed by exposure to pyrethrins, made any regulatory determinations, or proposed any regulatory action. EPA's cancer evaluation can be described, at best, as a "partial" risk assessment.

SUMMARY OF ARGUMENT

   To prevail over a Motion to Dismiss, the complainant must set forth "sufficient information to suggest that there exists some recognized legal theory upon which relief may be granted." District of Columbia v. Air Florida. Inc., 750 F.2d 1077, 1081 (D.C. Cir. 1984). Accordingly, a court must assume all factual allegations are true and must dismiss a complaint if the plaintiff fails to establish a rid to relief based on the facts alleged in the complaint. Gregg v. Barrett, 771 F.2d 539 (D.C. Cir. 1985).

   This Court does not have jurisdiction over Plaintiffs' claims because EPA's revised cancer risk assessment of the pyrethrins and its ongoing dioxin reassessment are not "final agency actions" so as to be reviewable under the Administrative Procedure Act, ("APA"). 5 U.S.C. § 706. The two risk reassessments have no binding legal effect on the EPA, Plaintiffs or any other party, and do not represent the consummation of any agency process. Accordingly, the Complaint must be dismissed.

   Plaintiffs also have failed to state a claim on which relief can be granted because EPA's 1986 cancer guidelines are not a regulation. Plaintiffs do not challenge the quality or accuracy of the Agency's scientific determinations, but instead argue simply that the Agency must follow the 1986 Guidelines, regardless of the scientific justification for doing so, until such time as the Guidelines are formally revised. Because the Guidelines are not a regulation, there is simply no basis in law or logic for EPA to use the 1986 Guidelines in preparing risk assessments when more recent methods are available that reflect the constantly-emerging science in this area.

   Further, all of the Plaintiffs lack standing to bring this action. Plaintiffs can demonstrate none of the three critical elements of standing: injury-in-fact, causation, or redressability. Tozzi's challenge to EPA's use of the cancer risk assessment guidelines amounts to a generalized grievance common to members of the public and not a particularized injury. Further, all of the Plaintiffs' alleged injuries are too remote and speculative to establish a concrete injury-in-fact. Causation is lacking because Plaintiffs cannot demonstrate that their alleged injury is dependent on the challenged risk reassessments rather than pre-existing risk assessments by EPA or other scientific bodies. For similar reasons, the relief sought by Plaintiffs is unlikely to redress their purported injuries.

   Finally, Plaintiffs' claim that EPA violated the Congressional Review Act ("CRA"), 5 U.S.C. 801, et seq ., by not submitting the 1996 and 1999 proposed revised cancer guidelines to Congress, should be dismissed because the CRA itself states that violations of that Act are not subject to judicial review." 5 U.S.C. § 805

1. THIS COURT LACKS SUBJECT MATTER JURISDICTION BECAUSE THE CHALLENGED GUIDANCE DOCUMENTS ARE NOT FINAL AGENCY ACTION

   Plaintiffs seek review of two instances of EPA's use of the cancer risk assessment guidelines under the APA. However, the waiver of sovereign immunity under the APA is limited to "final agency action." 5 U.S.C. § 704. If the challenged agency action is not final, the court lacks subject matter jurisdiction for judicial review. Veldhoen v. United States Coast Guard. 35 F.3d 222, 225 (5th Cir. 1994).⁽¹⁾

   The Supreme Court has established that two conditions must be satisfied for agency action to be final under the APA. Bennett v. Spear, 520 U.S. 154, 177 (1997). First, the action "must be one from which 'rights or obligations have been determined,' or from which 'legal consequences will flow.'" id. (citations omitted); see also Action on Smoking & Health v. Dep't of Labor, 28 F.3d 162, 165 (D.C. Cir. 1994) (agency action is not final unless it "imposes an obligation, denies a right, or fixes some legal relationship"). Second, the action "must mark the 'consummation' of the agency's decisionmaking process," and not be "of a merely tentative or interlocutory nature." 520 U.S. at 177.

   For the reasons that follow, the challenged risk assessments do not satisfy either of the conditions for final agency action identified in Bennett. They do not independently impose any obligations, deny any rights, or otherwise fix any legal relationship. Nor do they mark the consummation of EPA's decisionmaking process, because they are merely informative tools for EPA decisionmakers. They do not themselves represent any decision with regulatory consequences.

   A. EPA's Revised Cancer Risk Assessment for Pyrethrins' is Not Final Agency Action

   In challenging the pyrethrins' revised partial cancer risk assessment, Plaintiffs seek to involve this Court in review of an intermediate step in EPA's efforts to complete the FIFRA reregistration and the FFDCA tolerance reassessment processess for pyrethrins. This intermediate step, however, does not fix the rights or responsibilities of the Plaintiffs or result in legal consequences for Plaintiffs because it is not determinative of the regulatory outcome of reregistration or tolerance reassessment. Neither does the intermediate risk assessment step constitute the consummation of the agency's decision-making regarding FIFRA reregistration or FFDCA tolerance reassessment. This partial risk assessment is the subject of a reconsideration request and will remain subject to revision by EPA up until a regulatory decision is made. Further, the partial risk assessment does not even conclude the cancer portion of pyrethrins risk assessment. Accordingly, review of the revised partial cancer risk assessment should await the ultimate regulatory outcome of the reregistration and tolerance reassessment processes.⁽²⁾

      1. No Legal Consequences Flow from the Revised Partial Cancer Risk Assessment

   In conducting FIFRA reregistration, EPA must decide whether a pesticide causes an "unreasonable risk." 7 U.S.C.§ 136(bb). The FFDCA tolerance reassessment requires an examination by EPA of whether a tolerance is "safe." 21 U.S.C. § 346a(b)(2)(A). Although, as explained below, a finding concerning cancer potential is an important preliminary step in making these unreasonable risk and safety decisions, a finding that a pesticide is a carcinogen is not determinative of the ultimate outcome of these decisions and thus results in no legal consequences.

   The assessment of what particular hazards a pesticide may pose (e.g., cancer, birth defects) is just the first step in assessing the magnitude of the risk a pesticide may pose. If that initial scientific assessment shows, as it did with pyrethrins, that the pesticide is, or may be, a carcinogen, then EPA must evaluate the route, duration, and magnitude of exposure to the pesticide in order to quantify the magnitude of the risk. See 61 Fed. Reg. 17,960, 17,970 (April 23, 1996); 51 Fed. Reg. 33,992, 33,996 (Sept. 24, 1996). Once the magnitude of the risk is understood, EPA is generally able to evaluate whether regulatory action is required under the FFDCA as part of the tolerance reassessment.⁽³⁾ See H. Rep. 104-669, pt. 2 at 41 (1996) ("The Committee expects . . . that a tolerance will be considered to provide a reasonable certainty of no harm if any increase in lifetime risk, based on quantitative risk assessment using conservative assumptions, will be no greater than negligible.) Under FIFRA, however, assessing a the magnitude of a pesticide's risk is only half of the reregistration process. FIFRA also requires EPA to evaluate a pesticide's risks in light of the benefits provided from use of the pesticide.⁽⁴⁾ Until regulatory action is taken by EPA, however, Plaintiffs' legal rights and obligations are not affected. Simply stated, there are no legal consequences that flow from the release of the 1999 revised partial cancer risk assessment in the CPRC report for pyrethrins.

   The D.C. Circuit has emphasized that an agency report must have legal consequences to constitute reviewable agency action. See Industrial Safety Equipment Ass'n v. EPA, 837 F.2d 1115, 1120-21 (D.C. Cir. 1988). That is true, even where the agency report contains conclusions viewed as potentially economically damaging to commercial products. In Industrial Safety Equipment, an association representing safety equipment manufacturers argued that the alleged "substantial impact" from an EPA report recommending against the use of certain asbestos-protection respirators justified judicial review of the report. The court disagreed, pointing out that "publication of the Guide establishes no rule that the regulated industry must obey . . .[and] does not deny any rights to the appellants. Rather, any effect it might have on [the product] manufacturers is indirect and arises from the reactions and choices of industry customers and workers." Id. at 1121.

   The facts in Bennett v. Spear provide a useful contrast to the situation in Industrial Safety Equipment and the present case. There, the Court found that a Biological Opinion issued by the Fish and Wildlife Service pursuant to the Endangered Species Act was final agency action, because it represented the consummation of the Service's process, and because the Opinion had "direct and appreciable legal consequences" on the Bureau of Reclamation's operation of a water project which was alleged to be jeopardizing endangered species. 520 U.S. at 178. Specifically, the Opinion and accompanying Incidental Take Statement "alter the legal regime to which the action agency is subject, authorizing it to take the endangered species if (but only if) it complies with the prescribed conditions." Id. at 178.

   The partial cancer risk assessment in the CPRC report for pyrethrins affects no rights or obligations of Plaintiffs, results in no legal consequences, and alters no legal regime. Rather, like in Industrial Safety Equipment, such risk assessment may, at most, have indirect impacts due to decisions made by third parties. Such impacts, however, are not cognizable under the Bennett v. Spear final agency action test.

      2. EPA's Revised Partial Risk Assessment for Pyrethrins Is Not the Consummation of EPA's Decisionmaking

   As indicated above, the EPA's revised partial cancer risk assessment for pyrethrins in the 1999 CPRC report is only an intermediate step in the risk assessment and regulatory process. This partial risk assessment does not predetermine the regulatory outcome. It certainly is not the consummation of that process. The D.C. Circuit has repeatedly cautioned that an action is not final when the matter before the agency is still "in flux." See American Portland Cement Alliance v. EPA, 101 F.3d 772, 777 (D.C. Cir. 1996); Action on Smoking & Health v. Dep't of Labor, 28 F.3d 162, 165 (D.C. Cir. 1994). Rather, "[a]n agency's order becomes `final' or `effective' for appellate review purposes when the agency arrives at a terminal, complete resolution of the case before it. An order lacks finality in this sense while it remains tentative, provisional, or contingent, subject to recall, revision, or reconsideration by the issuing agency." Nat'l Treasury Employees Union v. FLRA,712 F.2d 669, 670-671 (D.C. Cir. 1983).

   In several ways, regulatory matters regarding the pyrethrins are still in flux at EPA, and the 1999 CPRC report may have little or no impact on EPA's ultimate regulatory decision. First, EPA may revise its cancer classification for pyrethrins. The major pyrethrin manufacturers have asked EPA to revisit its 1999 CPRC report and have indicated they intend to produce data challenging the conclusions in that report. Second, completion of a quantitative risk assessment may show that any cancer risk that is present is negligible and does not justify regulatory action. See, e.g., 65 Fed. Reg. 58,375, 58,380 (Sept. 29, 2000) (approving a tolerance based on finding the cancer risk of 7.1x 10⁸ for residues in food is below EPA's level of concern); 64 Fed. Reg. 19,050, 19,055 (April 19, 1999) (approving tolerance based on a finding that a cancer risk of 1.8 x 10⁶ is negligible). Finally, EPA may determine that dietary or worker risks other than cancer or environmental risks necessitate a FIFRA cancellation or a FFDCA revocation or modification of pyrethrin tolerances. Under any of these scenarios, the conclusions in the 1999 CPRC report would ultimately have little or no impact on EPA's regulatory action.

   The situation in this case is analogous to the facts of DRG Funding Corp. v. HUD, 76 F.3d 1212 (D.C. Cir. 1996). That case involved a dispute between a financial corporation and HUD over HUD's conclusions that (1) the financial corporation owed HUD a substantial sum due to the corporation's default under a mortgagebacked securities program, and (2) HUD could collect that debt through an offset against a judgment HUD was required to pay to the corporation. The corporation challenged these conclusions in an administrative proceeding before HUD; however, when HUD issued a determination that the offset was lawful, the corporation sought immediate judicial review of this decision. The D.C. Circuit dismissed the action on finality grounds. The court noted that HUD's determination clearly specified that the administrative process should continue with regard to the corporation's challenge to the validity of the underlying debt and that the resolution of this issue might completely "obviate the need for judicial review." Id. at 1215. Citing the Attorney General's Manual on the Administrative Procedure Act, 101-02 (1947), the court held that "any intermediate decision in the review procedure is necessarily 'tentative, provisional, or contingent,' and therefore nonfinal." DRG Funding, 76 F.3d at 1215 (quoting National Treasury Employees Union v. FLRA, 712 F.2d 669, 671 (D.C. Cir. 1983). Likewise, the 1999 CPRC report is an intermediate and non-determinative step in the reregistration and tolerance reassessment process. Numerous variables could obviate any need for review of this report.

      3. Judicial Review of the Revised Partial Risk Assessment Should Await Appropriate Regulatory Action

   Prior to EPA taking regulatory action regarding the pyrethrins, the 1999 CPRC report and the conclusion of the reregistration and tolerance reassessment processes remain in flux, and Plaintiffs' rights and obligations remain unaffected. If EPA takes regulatory action under the FFDCA or FIFRA, all of EPA's risk assessment, including its conclusions in the 1999 CPRC report regarding the cancer potentiality of pyrethrins, would be fully subject to the administrative and judicial review processes provided in the respective statutes.

   Accordingly, there is no final agency action on pyrethrins and no jurisdiction under the APA to review Plaintiffs' claims regarding this pesticide. Any judicial review of the 1999 CPRC report should await a final decision by EPA under the ongoing reregistration and tolerance reassessment programs, and should proceed through the existing statutory administrative and judicial avenues.

   B. The Dioxin Reassessment is Not Final Agency Action

   As with the pyrethrins reassessment, the dioxin reassessment does not determine rights or obligations, and does not mark the consummation of the Agency's decisionmaking process. The dioxin reassessment is not a final agency action subject to judicial review, and Plaintiffs' action should be dismissed for lack of subject matter jurisdiction.

      1. No Legal Consequences Flow from the Dioxin Reassessment

   The dioxin reassessment will not in and of itself have any legal consequences for any party. It is a scientific document that will help inform EPA decisionmaking. An illustrative example of the sequence of events that will follow issuance of the dioxin reassessment is EPA action under the Clean Water Act, 33 U.S.C. § 1251 et seq. EPA issues water quality criteria guidance to the states on the concentrations of pollutants, such as dioxin, in surface water that are consistent with the protection of surface waters for drinking water, fish consumption, and other uses. CWA Section 304(a), 33 U.S.C. § 1314(a). States then use this guidance as a basis for the adoption of regulatory water quality criteria, which are subject to EPA approval or disapproval. CWA Section 303(c), 33 U.S.C. § 1313(c). Existing state water quality criteria must be reviewed and revised as necessary at least every three years. CWA 303(c)(1), 33 U.S.C. § 1313(c)(1). Any permits issued under CWA authority must ensure attainment of regulatory water quality criteria. CWA Section 301(b)(1)(C), 33 U.S.C. § 1311(b)(1)(C).

   After EPA issues its dioxin reassessment, EPA's Office of Water will consider whether or not it should revise its existing 1984 dioxin water quality criteria guidance. Any such change in the guidance will be provided to states for their consideration in conducting their triennial review of regulatory water quality criteria. EPA's approval or promulgation of regulatory dioxin criteria based on EPA's reassessment would be final agency action subject to judicial review. See City of Albuquerque v. Browner, 865 F. Supp. 733 (D.N.Mex. 1993), aff'd 97 F.3d 415 (10th Cir. 1996). In any such challenge, the public and regulated community could argue that the dioxin reassessment was flawed, inaccurate, or outdated, or that it was misapplied by the Agency in its decisionmaking. Once a revised state regulatory dioxin criterion is in place, proposed surface water discharge permits in that state would thereafter need to ensure attainment of the revised regulatory criterion. For EPA-issued permits, the public and regulated entities would be afforded an opportunity to comment on a draft permit, 40 CFR 124.10, and to file an administrative appeal with EPA on any final permit. 40 CFR 124.19. Such challenges might include arguments to the effect that the facility's discharges need not be regulated to attain the applicable regulatory dioxin water quality criterion. At the conclusion of all administrative appeals of the discharge permit EPA's permit action would be final agency action for purposes of judicial review. See Adams v. EPA, 38 F.3d 43 (1st Cir. 1994).

   Two courts of appeals have found that interlocutory steps in this CWA regulatory process are not considered final agency action subject to review. Natural Resources Def. Council v. EPA, 16 F.3d 1395 (4th Cir. 1993), involved a challenge to EPA's 1984 water quality criteria guidance document for dioxin. This document "summarized the scientific information available . . . regarding dioxin toxicity and provided useful information for the states to use in adopting their own water quality standards." Id. at 1399 n.3. The criteria document described itself as "a non-regulatory, scientific assessment of ecological effects." Id. at 1407. The Fourth Circuit found that the criteria document was not a reviewable final agency action, stating that "[a]lthough this document does serve as an important reference manual to states as they develop water quality criteria for dioxin, we note that it does not purport to create or establish rights or responsibilities for any party, nor does it mandate legal action." Id. at 1407.

   Similarly, Plaintiffs in American Paper Inst. v. EPA, 882 F.2d 287 (7th Cir. 1989), sought review of an EPA regional office document entitled "Approach to Regulation of Dioxin Discharges from Pulp and Paper Mills that Bleach with Chlorine." The Court noted that if EPA's "'Approach to Regulation' ever leads to the denial or modification of a permit, the paper mill will be entitled to judicial review." Id. at 289. The Court explained that the dioxin guidance lacked finality because it had no practical impact on the parties. As the Court said, to have an impact "[i]t must have bite-- it must at least control the states or the permit holders, rather than serve as advice about how EPA will look at things when the time comes." Id.

   The dioxin reassessment is even further removed from "finality" than EPA's 1984 dioxin water quality criteria guidance and EPA's regional dioxin policy guidance, in that it is further removed from an action that actually has an impact on someone. Like EPA's water quality criteria guidance document, the dioxin reassessment serves as a useful "reference manual," but it does not establish rights or responsibilities for any party, nor does it mandate legal action. Like the water quality criteria guidance document and EPA's regional dioxin policy guidance, the dioxin reassessment has no "bite." It is not, in the words of Bennet v. Spear, an action from which "rights or obligations have been determined" or from which "legal consequences will flow." 520 U.S. at 178. To the extent that the dioxin reassessment is relevant to a future EPA regulatory action that does determine rights or obligations, Plaintiffs can raise their concerns with the reassessment at that time, and seek to have EPA's final action reflect their view of the science. If EPA does not adopt their view, Plaintiffs can challenge the EPA action through EPA administrative procedures and, ultimately, in the courts.

      2. The Dioxin Reassessment is Not the Consummation of EPA's Decisionmaking Process

   The dioxin reassessment also lacks finality because it is not the consummation of EPA decisionmaking. As a preliminary matter, the dioxin reassessment is not yet finished.⁽⁵⁾ Furthermore, even when finished it will not be a complete analysis of dioxin risks. The dioxin reassessment is directed at characterizing risks to human health from dioxin exposures; it does not address the risks that dioxin poses to aquatic life or wildlife.

   More importantly, publication of the dioxin reassessment will not end EPA's evaluation of the risks that dioxin poses to human health. Each time that EPA takes a regulatory action it will update the data and analysis presented in the reassessment, and consider public comments on the accuracy and methodology used in the reassessment before any conclusion or finding of the reassessment is relied on to establish a regulatory obligation. Thus, the dioxin reassessment does not mark the consummation of EPA's decisionmaking with respect to dioxin risks.

   In sum, the draft dioxin risk assessment does not constitute final agency action because it has no independent or binding legal effect. It is neither a rule nor an order. See Pacific Gas & Elec. Co. v. Fed. Power Comm'n, 506 F.2d 33, 37 (D.C. Cir. 1974) (policy statement is neither rule nor order). It is a statement of Agency position without binding effect on courts, EPA, the Plaintiffs, or anyone else. Nothing in the draft dioxin risk reassessment requires any party to take any affirmative action or to refrain from acting. Similarly, nothing in the document denies Plaintiffs or any other party any legal right. In addition, EPA is not bound by the dioxin reassessment, and will continue to evaluate dioxin risks to human health, as well as ecological impacts, prior to actually taking any action that has a binding effect on any party. To the extent that the dioxin risk reassessment is ultimately relied upon in reaching a final agency action, that risk reassessment would be part of the administrative record and EPA would have to defend against arguments that the reliance on the risk reassessment made the final action arbitrary and capricious. But this is neither the appropriate time, nor possibly the right forum, for such an inquiry.⁽⁶⁾

2. PLAINTIFFS FAIL TO STATE A CLAIM BECAUSE THE 1986 CANCER ASSESSMENT GUIDELINES ARE NON-BINDING GUIDANCE AND MAY BE AMENDED THROUGH PROCEDURES OTHER THAN NOTICE-AND-COMMENT RULEMAKING

   A complaint must be dismissed for failure to state a claim, if "no relief could be granted under any set of facts that could be proved consistent with [Plaintiffs'] allegations." Hishon v. King & Spaulding, 467 U.S. 69, 73 (1984). Although the court must accept as true all well-pleaded factual allegations and draw all reasonable inferences in favor of the Plaintiffs, Plaintiffs' legal conclusions receive no such presumption. Artis v. Greenspan, 158 F.3d 1301, 1306 (D.C. Cir. 1998). Because the very theory of Plaintiffs' Complaint hinges on demonstrably incorrect legal conclusion, -- i.e., that EPA's 1986 risk assessment guidelines are a binding rules that cannot be amended without notice and comment rulemaking, the Complaint must be dismissed for failure to state a claim.

   In their Complaint, Plaintiffs raise a procedural challenge to EPA's reliance in two cancer assessments on draft revisions to EPA's 1986 Cancer Assessment Guidelines. Plaintiffs claim that use of these draft revisions is unlawful because EPA has not promulgated these revisions as final rules through notice-and-comment rulemaking under section 553 of the APA The theory of Plaintiffs' case is that such rulemaking is required because the 1986 Cancer Assessment Guidelines were "promulgated...through rulemaking..." Compl. ¶ 2. This legal conclusion is absolutely essential to Plaintiffs' case: if the 1986 Cancer Assessment Guidelines are non-binding policy guidance and not a validly-promulgated binding, legislative rule, then EPA is not obliged to amend the guidelines through APA section 553 rulemaking and it would not be unlawful for EPA to use draft revisions to the 1986 Guidelines in conducting risk assessments. See Syncor Int'1 Corp. v. Shalala, 127 F.3d 90, 94 (D.C. Cir. 1997) ("The agency retains the discretion and the authority to change its position -- even abruptly -- in any specific case because a change in its policy does not affect the legal norm."). Plaintiffs' alleged legal conclusion regarding the promulgation of the 1986 Guideline as a rule, however, is demonstrably incorrect.

   When EPA released the 1986 Cancer Assessment Guidelines, the Agency stated that the Guidelines were "nonbinding policy statements." 51 Fed. Reg. 33,992 (Sept. 24, 1986). EPA consistently described the Guidelines as "proposed" or "final guidelines," not "proposed" or "final rules." See 49 Fed. Reg. 46,294 (Nov. 23, 1984). Moreover, the final Guidelines were published in the "Notices" section of the Federal Register not in the "Final Rule" section and the Guidelines were not included in the Code of Federal Regulations. Yet, Office of Federal Register regulations dictate that final rules must be published in the "Final Rule" section of the Federal Register and that "each Federal regulation of general applicability and legal effect" must be included in the Code of Federal Regulations. 1 C.F.R. §§ 5.9, 8.1; See Brock v. Cathedral Bluffs Shale Oil Co., 796 F.2d 533, 539 (D.C. Cir, 1986) ("Publication in the Federal Register does not suggest that the matter published was meant to be a regulation...The real dividing point between regulations and general statements of policy is publication in the Code of Federal Regulations . . . .").⁽⁷⁾ Finally, the language of the Guidelines repeatedly stresses that the Guidelines are designed to "guide" agency personnel while providing sufficient "flexibility" to address developing science. 51 Fed. Reg. at 33,993, 34,002. Such language is inconsistent with a binding legislative rule. In such circumstances, the Guidelines cannot qualify as binding, legislative rules under APA section 553 because the "notice" required by section 553 was not provided.

   EPA, thus, remains free to consider more recent policy pronouncements such as the 1996 and 1999 proposed revisions to the 1986 Guidelines in conducting cancer risk assessments. In fact, any other course would be in direct contravention of D.C. Circuit precedent. In Chlorine Chemistry Council v. EPA, 206 F.3d 1286, 1290 (D.C. Cir. 2000), the D.C. Circuit 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 1996 proposed revisions to the Cancer Assessment Guidelines. Accordingly, Plaintiffs' assertion that it is unlawful for EPA to use the 1996 proposed revisions to the 1986 Guidelines is difficult to square with the D.C. Circuit's conclusion that EPA ignores them at its peril.

3. EVEN IF THE RISK ASSESSMENT GUIDELINES WERE SUBJECT TO JUDICIAL REVIEW, THE PLAINTIFFS LACK STANDING TO BRING THIS CLAIM

   The "irreducible constitutional minimum of standing" requires that there be an injury-in-fact, together with "a fairly traceable connection between the plaintiffs injury and the complained-of conduct of the defendant," and "a likelihood that the requested relief will redress the alleged injury." Steel Co. v. Citizens for a Better Env't, 523 U.S. 83, 103 (1998) (citations omitted). "[T]he party invoking federal jurisdiction bears the burden of establishing its existence." Id., citing FW/PBS, Inc. v. Dallas, 493 U.S. 215, 231 (1990). See Florida Audubon Soc'y, et al., v. Bentsen, 94 F.3d 658 (D.C. Cir. 1996) (en banc). None of the Plaintiffs can establish that they meet these elements of standing. In fact, Plaintiffs' claims are so nonspecific, speculative, and indirect, that they can demonstrate neither injury-in-fact, causation, or redressability,

      1. Injury-in-Fact

   To demonstrate injury sufficient for standing, a party must show an "injury-in-fact" -- an "invasion of a legally protected interest which is (a) concrete and particularized" and (b) "actual of imminent, not 'conjectural' or 'hypothetical.'" Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992). "Abstract injury is not enough," it must be "real and immediate." Los Angeles v. Lyons, 461 U.S. 95, 101-102 (1983). Nor can the injury be one generally shared by the public. "[A] individual lacks standing to assert 'generalized grievances' about the conduct of Government." Spann v. Colonial Village, Inc., 899 F.2d 24, 27 (D.C. Cir. 1990) (quoting Schlesinger v. Reservists to Stop the War, 418 U.S. 208, 217 (1974)).

   The only allegation of injury by the Tozzi is that "Defendants' action threatens the continued availability of consumer products containing pyrethrins," Compl. ¶ 20. This allegation fails to meet the injury-in-fact requirement for several reasons. First, it is nothing more than mere conjecture. As discussed above, the "partial" cancer risk assessment for pyrethrins may or may not have an effect on the regulatory status of these pesticide products. For example, in Florida Audubon Soc'y v. Bentsen, 94 F.3d 658, 663 (D.C. Cir. 1996) (en banc), the court found that environmental groups lacked standing to challenge an Environmental Impact Statement for tax credit use of alternative fuel where claims of particularized injury and causation were based on a chain of conjecture that tax credit would increase fuel production. See also Louisiana Envtl. Action Network v. Browner, 87 F.3d 1379 (D.C, Cir. 1996) (injury based on a string of contingent government actions is not "imminent"). Second, Tozzi's speculative injury is one that is common to all members of the public. As such it is a mere "generalized grievance" and cannot be the basis for demonstrating injury-in-fact.

   Diatect, a manufacturer of products containing pyrethrins, claims that it is "reasonably concerned" that the pyrethrins risk reassessment will cause it economic harm due to publicity-undertaken by "activist groups". Compl.¶¶ 21, 40. Brevet, a manufacturer of products containing polyvinyl chloride, alleges that it stands to be harmed through "lost sales and damage to business reputation" if the dioxin reassessment is published as final. Compl.¶¶ 22, 49. Such assertions are no less conjectural than Tozzi's, hinging entirely on speculative acts of third party activist groups and guesses regarding the possible reaction of business customers and the general public to learning of EPA's reassessments. As described below, however, even more damaging to Plaintiffs' case is their inability to demonstrate causation or redressibility because the body of information already available from EPA and other governmental and public health organizations is more than sufficient to spur the kind of possible activity by activist groups that is the basis of Plaintiffs' allegations of harm. The challenged EPA actions therefore will not "cause" the alleged injury to Plaintiffs, nor will withholding the documents prevent the harm that Plaintiffs seek to avoid.

      2. Causation

   The causation inquiry examines whether there is "a fairly traceable connection between the plaintiffs injury and the complained-of conduct of the defendant." Steel Co. v. Citizens for a Better Env't. 523 U.S. 83, 103. Plaintiffs must demonstrate that the alleged injury-in-fact "is dependent upon" the challenged agency action. Wilderness Soc'y v. Griles, 824 F.2d 4, 18 (D.C. Cir. 1987). Here, none of the Plaintiffs can show that their alleged injuries are "fairly traceable" to, or "dependent on," the government actions challenged the use of the 1996 and 1999 proposed revisions to the 1986 cancer risk assessment guidelines in the 1999 pyrethrins partial cancer risk assessment or the dioxin risk reassessment.

   The harms alleged by Tozzi and Diatect relating to pyrethrins are not dependent solely on the 1999 CPRC report and EPA's use of the 1996 proposed revisions to the cancer risk assessment guidelines, The 1995 CPRC report concluded that pyrethrins were carcinogenic and that a quantitative cancer risk assessment was appropriate. Thus, Diatect's claimed injury, loss of business due to the characterization of pyrethrins as carcinogens, is not dependent solely on the 1999 CPRC report. The 1995 report reached essentially the same conclusion. Similarly, Tozzi's fear that the 1999 CPRC report will lead to cancellation of pyrethrins must logically be equally "dependent' 'on the 1995 report recommending a quantitative cancer risk assessment for pyrethrins, Yet, Tozzi challenges only the 1999 CPRC report. Plaintiffs must show that EPA action in the absence of the 1999 CPRC report would not cause the alleged harm. See Nat'l Law Ctr, on Homelessness & Povegy v. Kantor, 91 F.3d 178, 183 (D.C. Cir. 1996) (in challenge to census counting methodology, to demonstrate causation for standing, Plaintiffs "must show that the homeless were improperly undercounted by the S Night methodology [the challenged government act] as compared to a feasible, alternative methodology.")

   As to dioxin, EPA's existing 1985 cancer risk assessment identifies dioxin as a "probable" human carcinogen. Health Assessment Document for Polychlorinated Dibenzo p-Dioxins, EPA1600/8-84/014F, September 1985 at 2-8. The quantitative portion of EPA's 1985 risk assessment identifies both TCDD and a mixture of other dioxins as "two of the most potent carcinogens [yet] evaluated." Id. That document also identifies a host of other likely adverse human health effects associated with exposure to dioxin. Id. at 2-4 to 2-5. In addition, EPA is hardly alone in drawing attention to the hazards of dioxin. For example, the State of California, where Brevet is located, Compl.¶ 22, has placed TCDD on its lists developed pursuant to the Safe Drinking Water and Toxic Enforcement Act of 1986 (commonly known as "Proposition 65"), as a chemical "known to the state to cause cancer" and "known to the state to cause reproductive toxicity." Cal. Code Regs., tit. 22, § 12000(b), (c) (2001). Recently the U.S. Department of Health and Human Services Public Health Service, National Toxicology Program, updated its Ninth Report on Carcinogens to identify TODD as "known to be a human carcinogen." U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Report on Carcinogens, Ninth Edition, Carcinogen Profiles 2000 (dioxin addendum released January 19, 2001, available at https://ehis.niehs.nih.gov/roc/ninth/rahc/tcddsticker.pdf.). In these circumstances, proving that release of EPA's dioxin reassessment would be the cause of the harms that Brevet seeks to avoid would be difficult at best.

      3. Redressabilitv

   "Redressability examines whether the relief sought . . . will likely alleviate the particularized injury alleged by the plaintiff." Florida Audubon Soc'y, et al., v. Bentsen, 94 F.3d at 663-64. The inquiry should focus on whether it is "likely," as opposed to merely "speculative," that the injury will be "redressed by a favorable decision." Lujan v. Defenders of Wildlife, 504 U.S. at 561. Plaintiffs cannot demonstrate redressability for reasons similar to why they cannot show EPA's reliance on the revised guideline caused their alleged injury.

   Tozzi fears that EPA will remove pyrethrins from the market and requests that the 1999 CPRC report be declared invalid. Even if the court granted such relief, however, any EPA action concerning the cancer risks posed by pyrethrins is unlikely to be affected. If the 1999 CPRC report is set aside, the applicable cancer report for use the pyrethrins risk assessment would be the 1995 CPRC pyrethrins report that included a finding of carcinogenicity and recommended that a quantitative cancer risk assessment be performed. Tozzi has not claimed that a quantitative cancer risk assessment based on the 1995 CPRC report would vary from such an assessment carried out in reliance on the 1999 report, In the same manner, Diatect's fears regarding actions of third parties would not be addressed by removing only one of two CPRC reports.

   Similarly, Plaintiffs' request in its Prayer for Relief that the Court enjoin public release of the dioxin reassessment will not prevent the harms that Brevet seeks to avoid.⁽⁸⁾ Such an injunction would not effect EPA's existing 1985 risk assessment for dioxin, which includes the same type of statements and conclusions regarding dioxin risk that Plaintiffs now seek to keep from the public. Because activist groups can rely on the existing document to cause the harm Plaintiffs have alleged, enjoining release of the dioxin reassessment will not redress Plaintiffs' alleged injuries. Furthermore, enjoining release of the dioxin reassessment will not prevent activist groups from relying on information available from other sources on the risks associated with dioxin. See supra at p. 31.

4. PLAINTIFFS' CANNOT SEEK REVIEW UNDER THE CRA

   Finally, Plaintiffs also allege that EPA violated the Congressional Review Act, 5 U.S.C. 801, et seq., by not submitting the 1996 and 1999 proposed revised cancer guidelines for Congressional review as final agency rules. Plaintiffs' reliance on the CRA is misplaced since Section 805 of the CRA states, "[n]o determination, finding, action or omission under this chapter shall be subject to judicial review." 5 U.S.C. § 805.

CONCLUSION

    For the foregoing reasons, EPA respectfully requests that this Court dismiss the Complaint.

CERTIFICATE OF SERVICE

   I hereby certify that on February 5, 2001, a copy of the foregoing was served by first-class mail, postage prepaid, upon:

_________________
Gertrude Kelly

End Notes:

1. Plaintiffs do not identify any non-APA statutory waiver of governmental immunity from suit, and none exists that would cover the claims they advance here. It is well settled that neither of the other statutes cited in the "Jurisdiction" section of their Complaint - 28 U.S.C. § 1331 and the Declaratory Judgment Act (see Compl. ¶ 2 -constitute a waiver of sovereign immunity. See, e.g., Garcia v. United States. 666 F.2d 960, 966 (5th Cir. Unit B 1982) (28 U.S.C § 1331 does not waive the United States' immunity); Amalgamated Sugar Co. v. Bergland, 664 F.2d 818, 822 (10th Cir. 1981) (28 U.S.C. § 2201 does not waive the United States' immunity); Benvenuti v. Dep't of Defense, 587 F. Supp. 348, 352 (D.D.C. 1984) (neither 28 U.S.C § 1331 nor 28 U.S.C. § 2201 waives the United States' immunity).

2. Certainly nothing in the judicial review provisions of FIFRA or the FFDCA provides Plaintiffs with a right to judicial review at this time. See 7 U.S.C. § 136n; 21 U.S.C. § 346a(h).

3. The exception would be for the narrow group of pesticide tolerances that would qualify under section 408(b)(2)(B) as "eligible pesticide chemical residues." For this group of tolerances a specific benefits test is applicable. See 21 U.S.C. § 346a(b)(2)(B)(iii).

4. It should also be noted that a pesticide may pose other dietary risks than cancer that necessitate action under FIFRA or the FFDCA. Further, adverse action against a FIFRA registration may be required due to risks to workers or the environment.

5. A draft of the document is currently undergoing peer review by EPA's Science Advisory Board. Once the SAB report is issued, EPA will revise the draft reassessment to incorporate the SAB's comments as appropriate, and to-reflect EPA's continuing evaluation of the draft document and the emerging science.

6. Some of the actions EPA might take in reliance on the dioxin reassessment may be reviewed only by a court of appeals rather than a district court. See, e.g., 33 U.S.C. § 1369(b)(1)(F) (review of CWA permits). It is moreover well settled in this circuit that where review of final agency action is committed to the exclusive jurisdiction of the court of appeals, that court generally also has exclusive jurisdiction over a reviewable interlocutory step leading to the final action. Telecomm. Research & Action Ctr. v. FCC, 800 F.2d 1181, 1186 (D.C. Cir. 1986).

7. EPA did provide notice of the Guidelines, and seek public comment on the proposed Guidelines, through publication in the Federal Register. However, in using notice-and-comment procedures on a policy statement such as the Guidelines, EPA was merely following a recommendation of the Administrative Conference of the United States to use such procedures for policy statements where possible. ACUS Recommendation 76-5, Interpretive Rules of General Applicability and Statements of General Policy, 41 Fed. Reg. 56,769 (1976). If policy statements are held to be converted to binding rules whenever the Agency relies on notice-and-comment procedures, agencies would be effectively discouraged from using the widely-distributed and widely-read Federal Register as a means of seeking public input in devising agency policies.

8. That Plaintiffs' speculative claimed injuries are insufficiently concrete and imminent to establish standing also raises concerns regarding the ripeness of their claims. As we have shown, the risk assessments have no effect on these Plaintiffs, and the injuries they assert are speculative and remote. See Louisiana Envtl. Action Network v: Browner 87 F.3d 1379, 1384 (1996) (ripeness and standing analyses overlap).