IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA

   Plaintiffs have applied for a preliminary injunction in this action to prevent EPA from publicly releasing a reassessment of human health risks associated with exposure to dioxin - a group of highly toxic, persistent, and widely-dispersed chemicals. Plaintiffs assert that EPA cannot conduct a scientific risk assessment taking into consideration all scientific advances, but must adhere to the methods specified in a 1986 document that EPA stated was guidance at the time it was issued, and which Plaintiffs concede was not issued pursuant to rulemaking proceedings. Plaintiffs wish to constrain the substance of EPA's scientific judgment by forcing EPA to adhere to an alleged "rule" In the hope that dioxin, associated with products they produce, will be described in EPA's dioxin reassessment as a "probable human carcinogen" rather than a "human carcinogen."

   Plaintiffs have failed to satisfy the requirements for a preliminary injunction and their motion should be denied. Plaintiffs do not and cannot show any likelihood of success on the merits of their claims, because: (1) when issued the dioxin reassessment will not be a final agency action subject to judicial review, (2) the 1986 risk assessment guidance that Plaintiffs' allege EPA should follow in conducting the dioxin reassessment is not a rule and, like draft updates of that guidance, serve only as general guidance on EPA risk assessments, (3) Plaintiffs claims under the Congressional Review Act are barred by the express terms of that statute, and (4) Plaintiffs lack standing to bring this action. Plaintiffs have not shown that the balance of the equities or the public interest favor issuance of this motion, since their alleged harm is entirely speculative and controverted by their own statements. Plaintiff Brevet, a manufacturer of connectors for PVC tubing asserts that there is currently no available alternative to PVC tubing, Pls. Prelim. lnj. Mem. Ex. T at ¶ 5, and yet attempts to justify its standing to sue based on a claim that EPA's identification of dioxin as a "human carcinogen" will cause manufacturers of PVC tubing to switch to the use of alternative materials, id., at ¶¶ 6-10. In contrast to the absence of harm to Plaintiffs, any delay in issuance of the dioxin reassessment will adversely affect EPA's and the public's interest because it will frustrate efforts of public health agencies to use the most recent data and analysis on dioxin risks in formulating programs designed to protect human health from contaminants in food and the environment.

   As part of its mission under various statutes to protect human health from exposure to chemicals in the environment, EPA routinely assesses the potential for chemicals to cause cancer in humans. Because new techniques of assessing carcinogenic potential are continually being developed, EPA scientists regularly review 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 (Apr. 23, 1996); Guidelines for Carcinogenic Risk Assessment, July 1999 Review Draft, available at https://www.epa.gov/ncea/raf/crasab.htm (Exhibit A).

   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 at existing or expected exposure levels). The cancer guidelines 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 EPA's decision. EPA will also consider additional scientific information and factors unrelated to health risk (such as economic factors) that may be required under the governing statutory scheme. In addition, after issuing a proposed regulation or draft permit, EPA 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 effecting EPA's ultimate decision. 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. To the extent any such final action rests, in whole or in part, on a cancer risk assessment the validity or adequacy of that risk assessment can then be tested through judicial review of the final action.

   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 ("TCDD").

   EPA's last comprehensive risk assessment of TCDD and certain of the other dioxinswas completed in 1985. Health Assessment Document for Polychlorinated Dibenzo-p-Dioxins, EPA/600/8-84/014F, September 1985, (Exhibit B). 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 each 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. at 2-8, 11-125 to 11-131.

   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. See 65 Fed. Reg. 36,898, 36,899 (June 12, 2000). 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 revisions necessary in light of SAB comments and to then issue the dioxin reassessment.

   Among other advances, it is expected that the dioxin reassessment will address the risks associated with a greater number of dioxins than the 1985 risk assessment, and will set 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 or dioxins, rather than to individual dioxin compounds. The most recent publicly-available draft dioxin 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 III: Integrated Summary and Risk Characterization (September 2000 SAB Review Draft) at 19-49, available at https://www.epa.gov/ncea/pdfs/dioxin/dioxreass.htm. (Exhibit C). The draft reassessment 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 a 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 dioxin reassessment will be a scientific document, and will have no regulatory consequences in and of itself. If and when EPA proposes to use the dioxin reassessment as part of the basis for any future EPA regulatory action, any relevant faults in the reassessment could furnish a basis for public comment, administrative challenge (in permit and licensing proceedings) and, after issuance of final agency action, judicial review.

   "It frequently is observed that a preliminary injunction is an extraordinary and drastic remedy, one that should not be granted unless the movant, by a clear showing, carries the burden of persuasion." Mazurek v. Armstrong 520 U.S. 968, 972 (1997); The movant's burden is particularly heavy where, as here, the interim relief sought is to restrain a governmental program intended to serve the public interest. Yakus v. United States , 321 U.S. 414, 440 (1944).

   In this Circuit; the factors considered in determining whether to grant a preliminary injunction are: (1) the likelihood of plaintiffs' success on the merits; (2) the possibility that the plaintiffs will suffer irreparable injury if relief is denied; (3) the extent to which the balance of hardships favors the respective parties; and (4) whether the public interest will be advanced by preliminary relief.  Nat'l Ass'n of Farmworkers Organizations v. Marshall, 628 F.2d 604, 613 (D.C. Cir. 1980); Va. Petroleum Jobbers Ass'n v. Fed. Power Comm'n. 259 F.2d 921, 925 (D.C. Cir. 1958). Plaintiffs have the burden of proving the need for injunctive relief; Defendant bears no burden to defeat the motion.

Granny Goose Foods, Inc. v. Board of Teamsters Local 70, 415 U.S. 423, 442-43 (1974). "The injury must be both certain and great; it must be actual and not theoretical." Kahane v. Secretary of State, 700 F. Supp. 1162, 1165 (D.D.C. 1988). This is an exacting standard that, as we explain below, Plaintiffs have not met.

   Plaintiffs seek a preliminary injunction enjoining EPA from releasing its reassessment of the risks posed by dioxin. Plaintiffs claim that reassessment will be unlawful under the APA because EPA plans to rely on updated methodologies rather than its 1986 Cancer Assessment Guidelines. Plaintiffs are unlikely to succeed on the merits of their action, because the waiver of sovereign immunity under the APA is limited to actions for review of "final agency action," 5 U.S.C. § 704, and the dioxin reassessment is not "final agency action." 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). ^2/

   As explained in EPA's Motion to Dismiss, 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 "mast be one by 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.

   Plaintiffs' request for a preliminary injunction must be denied because their complaint challenges a dioxin reassessment that EPA is still in the process of revising. Regardless of whether the document would be final agency action under the APA, once it is issued, the reassessment unquestionably cannot be reviewed now. See note 1 supra. Plaintiffs are seeking judicial review before the Agency even completes its dioxin reassessment, and there is simply no authority for such interference in EPA's administrative process.

   In fact, however, even when "final," the dioxin reassessment will not satisfy either of the conditions for final agency action identified in Bennett. It will not independently impose any obligations, deny any rights, or otherwise fix any legal relationship. Nor will it mark the consummation of EPA's decisionmaking process, because it is merely an informative tool for EPA decisionmakers. The dioxin reassessment will not by itself represent any decision with regulatory consequences.

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 even 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 permits, 40 C.F.R. § 124.10, and to file an administrative appeal with EPA on any final permit. 40 C.F.R. § 124. 19. 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 (1^st Cir. 1994).

   Two courts of appeals have found that interlocutory steps m this CWA regulatory process are not final agency action subject to review. Natural Res. 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 is "a non-regulatory, scientific assessment of ecological effects." Id. at 1407. The Fourth Circuit found that the criteria document is 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 far 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 Am. 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 is 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 will be even further removed from "finality" than EPA's 1984 dioxin water quality criteria guidance and EPA's regional dioxin policy guidance, in that it will be further removed from an action that actually has an impact on someone. Like EPA's water quality criteria guidance document, the dioxin reassessment will serve as a useful "reference manual," but it will not establish rights or responsibilities fur any party, nor will it mandate legal action. Like the water quality criteria guidance document and EPA's regional dioxin policy guidance, the dioxin reassessment will have no "bite." It will not be, in the words of Bennett 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 may be 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.

   The dioxin reassessment will also lack finality because it will not be the consummation of EPA decisionmaking. 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 analyses presented in the dioxin 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, even the dioxin reassessment will not mark the consummation of EPA's decisionmaking with respect to dioxin risks.

   Plaintiffs erroneously claim that the dioxin reassessment is judicially reviewable final agency action because it is an "informational document," which they allege will have "severe repercussions" on them. Plaintiffs ignore extensive case law from the Supreme Court, the D.C. Circuit and elsewhere holding that informational reports that do not have direct legal consequences are not final agency action. Instead, the Plaintiffs rely on three district court decisions that are clearly out of step with Supreme Court and other authority on "final agency action." See Pls. Prelim. Inj. Mem at 10-12.

   The Supreme Court has repeatedly held that government reports that do not determine rights or obligations are not final agency action. See Franklin v. Mass., 505 U.S. 788, 796-800 (1992) (holding the Secretary of Commerce's report tabulating the results of the census was not final agency action because it "carried `no direct consequences' and served `more like a tentative recommendation than a final and binding determination."'); Dalton v. Specter, 511 U.S. 462, 470 (1994) (holding base closing reports by the Secretary of Defense and Base Closure Commission were not final agency action because the recommendations in the reports were not binding on the President). Consistent with these cases, and with the cases arising under the Clean Water Act discussed above (supra, at 11), the D.C. Circuit has emphasized that an agency report must have legal consequences to constitute reviewable agency action. See Indus. Safety Equip. 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 Indus. Safety Equip., 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. Here, the effects that Plaintiffs claim will flow from the dioxin reassessment are similarly indirect.

   In contrast to this authority, Plaintiffs rely principally on two decisions from the Western District of Louisiana, Synthetic Organic Chem. Mfr. Ass'n v. Secretary, Dept. of Health & Human Services, 720 F. Supp. 1244 (W.D. La. 1989), and Dow Chemical, USA v. CPSC. 459 F. Supp. 378 (W.D. La. 1978). These decisions found agency cancer classifications to be final agency action under the APA even though they had no direct legal effect. These holdings are contradicted, however, by the Supreme Court's requirement in that an agency report is not final where it has no "direct . . . legal consequences," Bennett, 117 S. Ct. at 1169, and by the many other cases we have cited on this point.

   Plaintiffs also cite the federal district court decision in Flue-Cured Tobacco Coop. Stabilization Corp. v. EPA, 857 F. Supp. 1137 (M.D.N.C. 1994), appeal pending. (4th Cir.). That court held that EPA's report on the cancer potential of environmental tobacco smoke was reviewable final agency action even though the court recognized the report had no more than an "indirect" regulatory effect and "the Report and [cancer] classification do not themselves create any legal rights or obligations." Id. at 42. The court relied on the fact that the report would have a persuasive effect on action by other government agencies. This decision, which EPA is appealing, is directly inconsistent with Franklin, Dalton, Bennett, and Ind. Safety Equip. Those cases demonstrate that an agency report, no matter how influential, is not final agency action unless the report itself fixes rights or obligations or has direct legal consequences.^3/ Moreover, the district court in the Flue-Cured Tobacco seemed to be influenced to a large degree by the fact that, as to second-hand tobacco smoke, EPA was authorized to do no more than issue a report; EPA could not take further regulatory action. Flue-Cured Tobacco, 857 F Supp. at 1144. That is not the case as to dioxin.

   Plaintiffs speculate that EPA and other governmental agencies will rely on the dioxin reassessment in taking regulatory action. Pls. Prelim. Inj. Mem. at 12-14. Yet, as described above, the Supreme Court expressly rejected the notion in Franklin and Dalton that subsequent regulatory action could furnish the "direct legal consequences" necessary to make a report "final agency action."

   Inappositely, Plaintiffs assert that: (l) EPA's issuance of the 1986 cancer risk assessment guidelines constitutes reviewable "final agency action" under the APA and (2) EPA's use of the guidelines also is "final agency action."^4/ Pls. Prelim. Inj. Mem. at 14-18. Both arguments are red herrings that divert attention from the critical issue of whether the action under review -- dioxin reassessment --is "final agency action."

  Plaintiffs do not seek review of the 1986 Cancer Guidelines or any of EPA's subsequent revisions to the Guidelines. Instead, they claim that the dioxin reassessment will be flawed because EPA relied on what they claim is the wrong set of guidelines. It is the reassessment that Plaintiffs must show is final agency action, and as shown above, they cannot do so.^5/ See Compl.

   1. To establish jurisdiction in this Court to challenge the lawfulness of the dioxin reassessment, Plaintiffs must show that the dioxin reassessment, and not some other action, is "final agency action."

   The claim that the use of the Cancer Assessment Guidelines in the dioxin reassessment constitutes final agency action is meritless. First, EPA has not completed the reassessment. Second, an agency's rationale for reaching a decision is not itself final agency action. Just as a judicial litigant can be adversely affected by, and thus can appeal, only a judgment and not the court's rationale, an agency's rationale does not have sufficient effect on a person's rights or obligations to constitute final agency action. See United States v. Accra Pac., Inc., 173 F.3d 630, 632 (7^th Cir. 1999) ("A court of appeals reviews judgments, not opinions. Someone who seeks an alteration in the language of the opinion but not the judgment may not appeal; likewise if the document is an administrative decision rather than a judicial one.") To establish jurisdiction in this Court to challenge the dioxin reassessment, Plaintiffs must show that the dioxin reassessment itself will have direct legal consequences.

   In sum, the draft dioxin risk assessment is not final agency action because EPA is still in the process of revising the document. Moreover, even when EPA finishes the reassessment, it will not be final agency action under the APA because it will have no independent or binding legal effect on EPA, the Plaintiffs, or anyone else. Nothing in the dioxin reassessment will require any party to take any affirmative action or to refrain from acting. Similarly, nothing in the document will deny Plaintiffs or any other party any legal right. In addition, EPA will not be bound by the dioxin reassessment, and will continue to evaluate dioxin risks to human health, as well to the environment, prior to actually taking any action that has a binding effect on any party. To the extent that EPA may, in the future, rely on the dioxin reassessment as part of its rationale for an action that does impose a legal requirement, any adversely affected party could raise its concerns with the reassessment at the time it challenges the regulatory action in question. But this is neither the appropriate time, nor possibly the right forum, for such an inquiry.^6/

   In its work on the dioxin ; reassessment EPA has attempted to incorporate the best arc most up-to-date scientific knowledge available. The reassessment has been subjected to numerous peer reviews and is undergoing another review both within the Agency and by specialists in carcinogenicity The reassessment will contain a detailed explanation of all of the data, assumptions, and methodologies used in deriving its conclusions.

   Plaintiffs assert that EPA's reliance on its 1996 and 1999 proposed revisions to the 1986 Cancer Assessment Guidelines in conducting the reassessment was arbitrary and capricious because EPA has never formally announced its intent to depart from the 1986 Guidelines, Pls. Prelim. Inj. Mem. at 20, and because EPA allegedly has not provided a reasoned explanation for the changes in policy contained in the proposed revisions. Id. For at least three reasons, these arguments lack merit.

   First, Plaintiffs' acknowledge in their brief that EPA announced in 1996 that it would be using the 1996 draft cancer guidelines on a case-by-case basis, including in the dioxin risk reassessment. Pls. Prelim. Inj. Mem. at 4-5 (citing 61 Fed. Reg. 32,779, 32,801 (June 25, 1996). Although EPA issued no such specific announcement with respect the 1999 draft risk assessment guidelines, it was under no obligation to do so. The dioxin reassessment is hot a rule, and there are no advance notice or other public participation processes prescribed by the APA or any other law for its development.

   Second, it is EPA's standing policy, consistent with all versions of its cancer risk assessment guidelines, to use the test available science in conducting risk assessments. It follows without the need for further notice, that EPA should use the 1999 risk assessment guidelines if those guidelines offer a scientific approach superior to earlier versions of the risk assessment guidelines. Indeed, the D.C. Circuit recently held that EPA acted arbitrarily and capriciously in issuing a rule that was inconsistent with EPA's view of the best available science, including scientific principles set forth in the 1996 proposed cancer guidelines. Chlorine Chemistry Council v. EPA 206 F.3d 1286, 1290 (D.C. Cir. 2000). In Chlorine, EPA issued a maximum contaminant level goal of zero for chloroform under the Safe Drinking Water Act, 42 U.S.C. 300f et seq. The rule was based on EPA's longstanding practice of assigning zero MCLG's to carcinogens, based on the general view that there is no safe threshold concentration below which exposure to carcinogens is without risk. See id. at 1287-1288. The Court found the challenged rule arbitrary and capricious because, among other reasons, EPA stated that the best available science indicated that there actually is a threshold (non-zero) concentration below which chloroform will pose no carcinogenic risk, and because EPA's 1996 proposed cancer guidelines specifically provided that in such circumstances EPA should not apply its general non-threshold default hypothesis. Id. at 1290. Plaintiffs' attempt to force EPA to base its dioxin reassessment on scientific understandings prevalent in 1986, and thus ignore fourteen years of developing science, is inconsistent with the D.C. Circuit's Chlorine decision.^7/

   Third, Plaintiffs' argument fails to take into account the administrative flexibility an agency has to depart from existing policy. A key characteristic of an agency policy, as opposed to a legislative rule, is that a policy can be amended without following a formal process, As to a policy, an "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 effect the legal norm." Syncor Int'1 Corp. v. Shalala, 127 F.3d 90, 94 (D.C. Cir. 1997). The agency must merely supply a reasoned analysis for its change in policy. Troy Corp. v. EPA, 120 F.3d 277, 286 (D.C. Cir. 1997). ("an agency is obligated not to depart without reasoned explanation from its prior conclusions'").

   In an appropriate challenge to a future application of the dioxin reassessment, EPA could be found to have acted arbitrarily and capriciously only if it fails to provide an adequate explanation for any deviations from its 1986 guidelines. This explanation could be supplied together with the proposed revised cancer risk guidelines, in the subsequent challenged agency action, or in the forthcoming dioxin reassessment document. Plaintiffs' claim that the proposed revisions do not provide any explanation is without merit. EPA explained its rationale for the major changes between the 1996 and 1986 versions of the cancer guidelines in a separate section of its Federal Register Notice inviting public comment on the 1996 draft guidelines. 61 Fed. Reg. 17,960,17,961-63. A draft revision of this discussion was included with the 1999 draft guidelines prepared for review by the Agency's Science Advisory Board. Exhibit A at v-xx. Moreover, given that EPA has not yet completed its dioxin reassessment, any claim that the reassessment will not supply any additional necessary explanation is nothing but speculation.

   EPA, thus, must be free to consider updated scientific principles such as those set forth in the 1996 and 1999 proposed revisions to the 1986 Guidelines in conducting the dioxin reassessment. In fact, any other course would be inconsistent with the D.C. Circuit's ruling in Chlorine, 206 F.3d at 1290.

   In unmistakably language, Congress has precluded judicial review of any ''determination, finding, action, or omission under the [Congressional Review Act]," 5 U.S.C. § 805. Despite this express bar on judicial review, Plaintiffs assert that judicial review is necessary to make the Congressional Review Act ("CRA") meaningful and that they are rot really seeking "review" of EPA's action but rather for this Court "to simply recognize and give effect to the plain congressional mandate.' Pls. Prelim. Inj. Mem. at 26. This argument must be rejected because it, in effect, asks this Court to rewrite the CRA.

   Plaintiffs contend that Congress' bar on judicial review should be construed narrowly and look to post-enactment legislative history to support their view that a court has authority to determine whether a rule has "taken effect" under section 801 of the CRA. Plaintiffs' argument, however, fails at every turn. First, although judicial review over administrative action is generally favored, it is certainly within Congress' prerogative to deny judicial review with respect to a given matter. Bowen v. Mich. Acad. of Family Physicians, 476 U.S. 667, 673 (1976) ("Subject to constitutional constraints, Congress can, of course, make exceptions to the historic practice whereby courts review agency action."): see also 5 U.S.C. § 701 (generally providing for judicial review of agency action except where "statutes preclude judicial review")

   Second, because the statute is unambiguous, Plaintiffs' resort to legislative history is unwarranted. Ardestani v. INS, 502 U.S. 129, 135-1361(1991) ("The strong presumption that the plain language of the statute expresses congressional intent is rebutted only in rare and exceptional circumstances). On its face, the statute bars judicial review of agency omissions under the statute and that is precisely what Plaintiffs seek here - a review of EPA's alleged omission to provide the proposed revisions to the cancer risk assessment guidelines to Congress.

   Third, even if it was appropriate to consult legislative history in this case. the legislative history Plaintiffs rely upon is particularly weak. The individual statements by congressmen relied upon by Plaintiffs all were inserted into the record after March 29, 1996 -- the date of enactment of the CRA. See Pub. L. No. 104-121, 110 Stat. 862 (Mar. 29, 1996); 143 Cong. Rec. S3686 (Apr. 18, 1996) (statement of Sen. Nickles); 143 Cong. Rec. E577 (Apr, 19, 1996) (statement of Rep. Hyde). For good reason, courts give little weight to post-enactment statements of individual legislators. Thomas v. Network Solutions Inc., 176 F.3d 500, 507 n.10 (D.C. Cir. 1999) ("Such isolated post-enactment statements, to the extent that they are legislative history, carry little weight, and in any event, do not alter the plain meaning of this statute."); Cont'l Air Lines, Inc. v. Dep't of Transp., 843 F.2d 1444. 1447 n.3 (D.C. Cir. 1988) ("It should go without saying that post-enactment legislative history is singularly unavailing in the sensitive process of divining meaning."). As Justice Scalia succinctly put it, to "post-legislation legislative history" is an "oxymoron, United States v. Carlton, 512 U.S. 26, 39 (1994) (concurring opinion).

   Finally, Plaintiffs are just engaging in semantics to assert that a court's review of whether an agency has violated a statutory mandate, would merely give "effect" to that mandate, and would not constitute judicial review of an agency action or omission. Here, Plaintiffs' claim is that EPA's draft risk assessment guidelines are required to be submitted to Congress under the CRA and that EPA's "omission" in submitting them renders them ineffective. Plaintiffs' strained reading of the CRA cannot establish a cause of action barred by the statute's plain terms. See Fischer v. Resolution Trust Corp. 59 F.3d 1344, 1348 (D.C. Cir. 1995) (cannot avoid provision barring judicial review by "labored and unnatural construction of the statute").

   The "irreducible constitutional minimum of standing" requires that there be an injury-in-fart, together with "a fairly traceable connection between the plaintiff's 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)). Plaintiffs fail to establish that they meet these elements of standing.

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 or imminent, not 'conjectural' or 'hypothetical."' Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992) (citation omitted). "Abstract injury is not enough," it must be "real and immediate." Los Angeles v. Lyons. 461 U.S. 95, 101-102 (1983).

   Brevet Industries ("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 forthcoming dioxin reassessment is issued with a determination that dioxin is a "human carcinogen." Compl. ¶¶ 22, 49. Plaintiffs have submitted the Affidavit of Charles Brewer, President and Director of Brevet, to substantiate this claim. Pls. Prelim. Inj. Mem., Ex. T. The Brewer Affidavit, on its face, fails to explain how Brevet could be harmed for purposes of standing by release of the dioxin reassessment. Mr. Brewer asserts that Brevet produces both rigid polycarbonate connectors and flexible PVC connectors as its principal product line, Brewer Aff. at ¶ 4, and that these connectors are "designed to connect exclusively to flexible PVC tubing." Brewer Aff. at ¶ 5 (emphasis original). Further, he states that "[v]irtually all of Brevet's sales depend upon the continued use of flexible PVC tubing in the medical equipment industry." Id. Importantly, Mr. Brewer states that "I know of no presently available suitable substitute material for PVC tubing that offers the physical properties necessary to perform the critical functions of the devices used with the connectors Brevet produces."^9/ Id. (emphasis added.) In light of Mr. Brewer's unambiguous declaration that there are no available alternatives for PVC tubing in the medical applications regarding which Brevet's connectors are used, his opinion that as a result of the release of the dioxin reassessment his customers will immediately switch to the use of PVC. alternatives is simply not tenable.^10/ The harm alleged by Brevet is entirely "speculative,"' in that it rest s not only on the possibility that a substitute for PVC will be found sometime in the future, but also that of that future date EPA's finding that dioxin is a human carcinogen will make a material difference in activists' anti-PVC campaigns, and that Brevet's customers will change their practices as a result of those campaigns. It is also based on the conjecture that the label "human carcinogen" rather than "probable human carcinogen" will make a meaningful difference to environmental activists and the public. This chain of conjecture is insufficient to establish injury-in-fact- E.g., Fla. Audubon Soc'y v. Bentsen, 94 F.3d 658, 663 (D.C. Cir. 1996) (en banc) (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 La. Envtl. Action Network v. Browner, 87 F.3d 1379 (D.C. Cir. 1996) (alleged injury based on a string of contingent actions is not "imminent")^11/

   The causation inquiry examines whether there is "a fairly traceable connection between the plaintiff’s injury and the complained-of conduct of the defendant." Steel Co., 523 U.S. at 1(03. 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," EPA's use of updated cancer risk assessment guidelines in preparing the dioxin reassessment. In addition, they cannot show that the release of the forthcoming dioxin reassessment will cause them harm, or that withholding its release will prevent that alleged harms from occurring.

   The existing wealth of information and findings on the carcinogencity of dioxin from governmental and public health organizations are more than sufficient to cause the harms that Plaintiffs allege. Therefore, Plaintiffs cannot meet their burden to establish that EPA's forthcoming release of the dioxin reassessment will be the "cause" of their alleged harms. Dioxin is one of the most notorious of environmental contaminants. The release of EPA's dioxin reassessment with a characterization of dioxin as a "known carcinogen" will not "cause" harm to Plaintiff's by alerting activist groups and the public to dioxin risks, because activist groups are already well aware of the health effects of dioxin. See EPA Mem. at 31. (reviewing existing information on dioxin health effects). EPA's existing 1985 cancer risk assessment identifies TCDD as a "probable'' human carcinogen. Health Assessment Document for Polychlorinated Dibenzo-p-Dioxins, EPA/600/8-84/014F, Sept. 1985 at 2-8 (Exhibit B). See also id, ac 11-125 to 11131. Non-cancer adverse human health effects of TCDD include "chloracne, altered liver function, hematological abnormalities, porphyria cutanea tarda, hyherpigmentation and hirsutism." Id. at 8-88. In addition, occupational or accidental exposures to TCDD were shown to cause "sight disorders, loss of hearing, taste and sense of smell, central lassitude, weakness, impotence and loss of libido." Id. TCDD was also found to demonstrate a range of noncancer 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 addition to its 1985 dioxin risk assessment, EPA has publicly released 1994 and 2000 drafts of the dioxin reassessment. The latter document, available on the internet, includes the draft characterization of TCDD as a "human carcinogen" and mixtures of dioxins as "likely" human carcinogens. Exhibit C at 29-30. Although the draft reassessment includes a disclaimer that it should not be cited or quoted, some activist groups have already done so, as noted by Plaintiffs. See Pls. Prelim. Inj. Mem. at 30.

   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) (Exhibit F).

   The World Health Organization's International Agency for Research on Cancer ("IARC") published a monograph in 1997 that classified TCDD as "carcinogenic to humans," it's highest ranking or carcinogenic hazard. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Volume 69, Polychlorinated Dibenzo-para-Dioxins and Polychlorinated Dibenzofurans at 343, IARC Press 1997 (Exhibit G). IARC also noted that TCDD has been associated with "chloracne alterations in liver enzyme levels in both children and adults. Changes in the immune system and glucose metabolism have also been observed in adults. Infants exposed. . .through breastmilk exhibit alterations in thyroid hormone levels and possible neurobehavioral and neurological deficits." Id. at 339.

   In 1997, the Governing Council of the United Nations Environment Programme ("UNEP") requested that UNEP convene an international negotiating committee to prepare an international treaty addressing control of twelve "persistent organic pollutants" (POPs), including dioxin. See Exhibit H at 1. At the fifth session of this negotiating group, in December 2000, the negotiators from 122 countries approved a draft treaty. Id. at 7-11. This draft treaty recognizes the toxic nature of the 12 POPs and includes for them the most stringent international controls on chemical production and use that have ever been adopted. The draft treaty includes specific obligations related to reducing, and when feasible, eliminating releases of dioxins and several other unintentionally produced chemicals. See id., Article D, Paragraph 3 and Annex C. A meeting has been scheduled in Sweden from May 22-23 for adoption of the treaty, after which it is expected to be ratified by participating countries. Id. at 12, ¶ 87.

   Recently the U.S. Department of Health and Human Services Public Health Service, National Toxicology Program, updated its Ninth Report on Carcinogens to identify TCDD 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. (Exhibit I).

   The public availability of existing findings and documents regarding dioxin toxicity is demonstrated by many of the examples of activism and state regulatory activity that Plaintiffs themselves note in their brief. For example, Plaintiffs refer to resolutions by the Cities of Oakland, San Francisco and Berkeley to eliminate or reduce the use of products like PVC, the manufacture or disposal of which could generate dioxin pollution. Each of those resolutions states that dioxin is a "known human carcinogen," and provides a citation to IARC the finding. Pls. Prelim. Inj. Mem., Ex. R at ¶ 3, Ex. S at ¶ 3, Ex. Y, numbered ¶ 11, Plaintiffs cite a press report, Pls. Prelim. Inj. Mem. at 13, Ex. F., for the notion that the State of New Hampshire is developing a dioxin strategy in light of EPA’s finding that dioxin is a human carcinogen. However, the actual New Hampshire strategy cites the existing HHS finding to that effect, not EPA's draft findings. The New Hampshire Dioxin Reduction Strategy, Feb. 2001 at p.11 ( Exhibit J ). It is abundantly clear , that the harm Plaintiffs seek to avoid is ongoing, does not turn on EPA's finding that dioxin is a "human carcinogen," and is as likely to occur with or without EPA's issuance of a "final" dioxin reassessment. Therefore, the reassessment is not the" cause" of Plaintiffs' alleged harms and Plaintiffs lack standing.

   "Redressability examines whether the relief sought . . . will likely alleviate the particularized injury alleged by the plaintiff:" Florida Audubon Soc'y 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 essentially the same reasons they cannot show causation.

   An injunction prohibiting EPA from publicly releasing the dioxin reassessment will not prevent the harms that Brevet seeks to avoid.^12/ Such an injunction would not effect public availability of EPA’s existing 1985 risk assessment for dioxin, EPA's 2000 draft dioxin reassessment, IARC's 1997 Monograph on dioxin, California's determinations that dioxin is "known to the State to cause cancer" and reproductive toxicity, HHS's 9th Report on Carcinogens, or any of the many other documents that include the same types of statements and conclusions regarding dioxin risk that Plaintiffs seek to keep from the public. Because activist groups can rely on these existing documents to cause the harm Plaintiffs have alleged, enjoining the forthcoming release of the dioxin reassessment will not redress Plaintiffs' alleged injuries.

   Plaintiffs cite this Court's September 3 , 2000, decision in Tozzi v. DHHS ("Tozzi"), 2000 U.S. Dist. LEXIS 15990, 51 Env't. Rep. Cas. (BNA) 1893, app. pend., No. 00-5364 (D.C. Cir.), as support for their standing in this case. Pls. Prelim., Inj. Mem. at 31-32. Though distinguishable, Tozzi I is similar in some respects to this action, in that it involved a challenge to the Department of Health and Human Services' planned identification of dioxin as a "known human carcinogen" in its Ninth Report on Carcinogens. Tozzi I, 2000 U.S. Dist. LEXIS at *2. The district court found that Brevet had standing, id. at *10, but ruled against Brevet on the merits, id. at *15-*16. The findings regarding shading in Tozzi I are distinguishable from, the facts in the present case.^13/ First, in finding that Brevet had established injury in fact, the Tozzi I Court apparently assumed that substitutes for PVC tubing were available and that Brevet's customers were already moving towards selection of those alternative products. Id. at *7-*8. As described above, however, Mr. Brewer's affidavit in this case states that such substitutes are not available. Pls. Prelim. Inj. Mem., Ex. T at ¶ 5.

   Second, although the Court in Tozzi I rejected HHS's arguments that Brevet could not establish redressability in light of existing studies and governmental positions regarding; dioxin toxicity, Tozzi I, 2000 U.S. Dist. LEXIS at *10, the ground has substantially shifted since the Court rendered its opinion. Not only has a final international treaty been negotiated that identifies dioxin as one of a handful of chemicals warranting the most stringent international controls, "POPs Treaty," Exhibit H, but, HHS has issued its 9th Report on Carcinogens identifying dioxin (TCDD) as a "known human carcinogen." Exhibit I. Mr. Brewer stated in the affidavit that he filed in Tozzi I that:

^14/ Plaintiffs Tozzi and Diatect International claim that they will be harmed by release of the dioxin reassessment because "such release will confirm the agency's authority to use the disputed cancer risk assessment guidelines for risk assessment purposes." Pls. Prelim. Inj. Mem. at 2, fn. 1. A denial of a motion for preliminary injunction is not, however, a ruling on the merits, and so could not be construed as confirming" EPA's ability to use its draft cancer risk assessment guidelines in conducting risk assessments.