IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA JIM J. TOZZI, et al., Plaintiffs, v. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, et al., Defendants. Civil Action No. 00-2604 Judge Thomas Penfield Jackson PLAINTIFFS' APPLICATION FOR PRELIMINARY INJUNCTION

Plaintiffs, through their undersigned counsel, respectfully move the Court for entry of an Order enjoining Defendants, during the pendency of this litigation, from publicly releasing a final version of the EPA risk assessment for dioxin, which is a subject of this lawsuit. The EPA report, a current draft of which is entitled, "Exposure and Human Health Reassessment of 2,3,7,8-Tetrachlorodibenzo-p-Dioxin (TCDD) and Related Compounds", will have tremendous real world and regulatory consequences for Plaintiffs and the public.

As discussed in the accompanying memorandum of points and authorities in support of this application, Plaintiffs meet the necessary showing of (i) likelihood of success on the merits, (ii) threat of irreparable harm, (iii) absence of harm to non-moving parties, and (iv) public interest.

Defendants have asserted, and continue to assert, that they legally are entitled to use new draft cancer risk assessment guidelines as a basis for the dioxin reassessment. In particular, the agency is using these disputed guidelines, which were drafted in 1999 but which have never been formally adopted or subjected to congressional review, as a basis for the agency's conclusion that dioxin poses a dramatically higher cancer risk than had previously been estimated and should be placed in the highest carcinogen hazard classification. EPA's previous cancer risk assessment guidelines, which were formally adopted in 1986, would yield a substantially lower cancer risk characterization and would not permit classification of dioxin in the highest hazard classification category based on the given data set.

Prior events demonstrate beyond question that, if the dioxin reassessment is released as final in its current form, the report will be widely publicized and will greatly fuel efforts to ban the manufacture, sale and use of polyvinyl chloride ("PVC") products, including Plaintiffs' products. Plaintiffs will suffer severe and irreparable injury in the form of damage to business reputation and lost sales. Such damages, even if calculable, could never be recovered against the federal government.

For these reasons and for the reasons set forth in the accompanying memorandum, Plaintiffs respectfully request that the Court enjoin Defendants from publicly releasing the EPA dioxin reassessment as final until the Court has had an opportunity to rule on the merits of Plaintiffs' claims.

Plaintiffs, through undersigned counsel and pursuant to LCvR 65.1(c), file this memorandum of points and authorities in support of their attached application for preliminary injunction.

Plaintiffs request that the Court issue an order enjoining Defendants from publicly releasing as final a forthcoming EPA report entitled, "Exposure and Human Health Reassessment of 2,3,7,8-Tetrachlorodibenzo-p-Dioxin (TCDD) and Related Compounds" (hereinafter "dioxin reassessment"), until the Court has reached a final decision on the merits of this case.

The dioxin reassessment is based on non-final carcinogen risk assessment "guidelines". Defendants are violating the Administrative Procedure Act, 5 U.S.C. § 551, et seq. ("APA"), because the agency never formally adopted the guidelines as final, and there still exist final guidelines which the agency is not using for the dioxin reassessment. Even though the draft guidelines have never been finalized, EPA is using the draft guidelines as "rules" under the APA.

Use of the draft cancer guidelines also violates the Small Business Regulatory Enforcement Fairness Act, 5 U.S.C. § 801, et seq. ("Congressional Review Act" or "CRA"), because they were never submitted to Congress for review. They therefore have yet to "take effect" and may not be used as the basis for agency action, including preparation and publication of the final dioxin reassessment.

A preliminary injunction is necessary because EPA has announced that it is nearing completion of the review process for the dioxin reassessment. Defendants have agreed to provide Plaintiffs ten business days notice of any EPA decision to release the reassessment on or before the date of the Court's hearing on Plaintiffs' application for preliminary injunction. After the hearing, however, Plaintiffs will have no advance notice that EPA intends to release the dioxin reassessment publicly.⁽¹⁾

In order for the Court to have an opportunity to fully review this case on the merits, Defendants must be directed not to release a final dioxin reassessment pendente lite.

The complaint in this case was filed October 27, 2000. Defendants sought and received an enlargement of time until January 19, 2001 to respond to the complaint. During discussion between counsel prior to that date, counsel for Defendants indicated that Defendants intended to move to dismiss some or all of Plaintiffs' claims, and counsel for Plaintiffs informed Defendants that Plaintiffs intended to file a motion for preliminary injunction. The parties reached agreement on a briefing schedule on the two motions, and Plaintiffs filed a consent motion for entry of that schedule on January 18, 2001. The Court granted the consent motion on January 22, 2001.

Pursuant to the agreed upon briefing schedule, the parties are filing simultaneous briefing on the instant motion and on Defendants' motion to dismiss. A hearing on the two motions has been set for March 16, 2001 at 10:00 a.m. The Court's January 22, 2001 Order confirmed Defendants' agreement to provide Plaintiffs ten days pre-publication notice in the event EPA intends to release the final dioxin reassessment on or before the date of the hearing.

In 1986 EPA issued "Guidelines for Carcinogen Risk Assessment" containing instructions on the use of certain analytical methodologies and policy positions for the conduct of human health risk assessments for suspected environmental hazards. The 1986 cancer guidelines were promulgated as "Final Guidelines", following public notice and comment. 51 Fed. Reg. 33992 (Sept. 4, 1986). The agency has never announced that these guidelines were being rescinded or superseded. As discussed further below, EPA has used the 1986 guidelines in a variety of regulatory contexts during the past 15 years to set agency policy and develop regulations.

In April 1996 EPA published new "Proposed Guidelines" for cancer risk assessment in the Federal Register and invited public comment. 61 Fed. Reg. 17960 (April 23, 1996). The notice stated, "When final, these guidelines will replace the 1986 guidelines." Id. (emphasis added). The agency issued a separate Federal Register notice later that year in which it invited comment on a proposal to "identify, prioritize and select agents for reevaluation." 61 Fed. Reg. 32779 (June 25, 1996). This notice also stated that the revised reevaluation process "would take effect when the Proposed Guidelines are issued as final". As previously noted, however, the 1996 proposed guidelines were never promulgated as final. The agency nonetheless announced that it intended to apply the proposed 1996 guidelines "in whole or in part on a case-by-case basis for new assessments as data warrant" and noted that EPA was using "new approaches to cancer reassessment" for its pending reevaluation of dioxin. Id. at 32801.

In 1999 EPA released another version of draft carcinogen risk assessment guidelines. The document was prominently labeled "DRAFT" and cautioned:

It has not been formally released by the United States Environmental Protection Agency and should not at this stage be construed to represent Agency policy. It is being circulated for comment on its technical accuracy and policy implications.

Another disclaimer on the inside cover (p. ii) of the 1999 draft guidelines describes them as a "work in progress" and notes that EPA is continuing to assess recommendations from the agency's Science Advisory Board. Excerpts of these draft cancer guidelines, dated July 1999, including the pages containing the cited text, are attached as Exhibit A. EPA has yet to publish the 1999 draft guidelines in the Federal Register for public comment, and it has not published them as final. These guidelines nevertheless are being used in the dioxin reassessment that the agency is planning to release soon.⁽²⁾

Both the 1996 and the 1999 proposed cancer guidelines differ significantly from the still effective, final 1986 guidelines. Under the 1986 guidelines, for example, placement of a substance in the highest level hazard classification requires sufficient epidemiological data, i.e., evidence derived from studies of human subjects exposed to the substance or agent. See Complaint Exh. 1. Evidence derived from studies of experimental animals and so-called "mechanistic" data are not considered in classifying a substance in the top hazard category under the 1986 guidelines. By contrast, both the 1996 and the 1999 guidelines would allow the agency to rely on non-epidemiological data to classify substances in the highest level hazard categories.⁽³⁾ The "weight of the evidence" approach in the draft 1999 guidelines, for example, allows classification of a substance in the highest, or "carcinogenic to humans", category in the absence of conclusive epidemiological evidence if there is (i) compelling animal data and (ii) mechanistic data. See Complaint Exh. 1. In addition, a dramatically higher quantitative risk estimate results from use of the 1999 guidelines.

In 1991 EPA announced a scientific reassessment of the human health and exposure issues concerning dioxin and dioxin-like compounds.⁽⁴⁾ 56 Fed. Reg. 50903 (Oct. 9, 1991). EPA completed a draft of the reassessment in 1994 and submitted the report to the agency's Science Advisory Board ("SAB"). The SAB recommended that two sections of the report be revised -- the risk characterization section and the dose-response chapter -- and also recommended that a new section be developed addressing dioxin toxicity equivalence factors ("TEF"). The SAB recommended (i) that these three sections be subjected to external peer review, and (ii) that the SAB review the new and revised sections before the reassessment is completed.⁽⁵⁾ EPA claims on its Internet website that it will not "use the conclusions of the draft dioxin reassessment for regulatory purposes until all the science peer reviews are completed."

The cancer hazard classification of the 1994 EPA report was based on the 1986 cancer guidelines. Using those guidelines, the agency concluded that dioxin should be classified as a "probable human carcinogen". Following the issuance of the 1996 proposed cancer guidelines and the 1999 draft guidelines, however, EPA began to rely on these later documents in certain risk assessments, including the dioxin reassessment.

Thus, in a draft of the revised dioxin reassessment released in May, 2000, EPA concluded that the risk of contracting cancer from environmental dioxin exposure at ordinary levels is dramatically higher -- 10 times higher for some populations -- than EPA had previously projected. Based on the 1999 draft guidelines, the hazard classification section of the draft report also upgraded dioxin to a "human carcinogen", the highest-tier hazard classification, elevating it from EPA's previous "probable human carcinogen" ranking. See C. Skrzycki, Washington Post (May 17, 2000) Exh. B.

In the 1994 draft, EPA had tentatively found that exposures to dioxin and related compounds would pose a cancer risk only at exposures ten to 100 times above general background levels. In the 2000 draft of the reassessment, by contrast, EPA tentatively concluded that there is a risk at current background levels. This is the fundamental conclusion stated in the dioxin reassessment that EPA intends to release as final.

Plaintiffs are entitled to a preliminary injunction if they establish four points: (1) likelihood of success on the merits; (2) irreparable harm if a preliminary injunction is not granted; (3) that the harm to Plaintiffs if a preliminary injunction is not granted outweighs the harm to Defendants if the preliminary injunction is granted; and (4) that granting of a preliminary injunction would further the public interest. Mova Pharmaceutical Corp. v. Shalala, 140 F.3d 1060, 1066 (D.C. Cir. 1998); Washington Metropolitan Area Transit Comm'n v. Holiday Tours, Inc., 559 F.2d 841, 843 (D.C. Cir. 1977).

Courts are to weigh all the elements together, and the D.C. Circuit has recognized that a strong showing on one factor, such as likelihood of success on the merits, can justify a preliminary injunction even if the showing on one or more other factors, such as irreparable injury, is relatively weak. CityFed Financial Corp. v. Office of Thrift Supervision, 58 F.3d 738, 747 (D.C. Cir. 1995).⁽⁶⁾

In the case at hand, there is a strong likelihood of success on the merits, and the balancing of possible harm and consideration of the public interest also strongly favor a preliminary injunction. The threat of irreparable harm, while having an element of quantitative uncertainty, is sufficient to support the requested relief. Accordingly, a preliminary injunction should be granted.

Plaintiffs's complaint sets forth two separate grounds for relief. As demonstrated below, Plaintiffs are likely to prevail on both theories when the Court hears the case on the merits.⁽⁷⁾

A. EPA's Release of a Final Dioxin Reassessment Based on Proposed and Draft Cancer Guidelines Would Violate the Administrative Procedure Act.

The dioxin reassessment is based on EPA cancer risk assessment guidelines that have never been finalized and which the agency is using, in violation of the APA, in lieu of still effective guidelines formally adopted in 1986. The report thus rests on arbitrary and capricious conduct and agency action not in accordance with law. 5 U.S.C. § 706(1)(A). Plaintiffs are entitled to relief under the judicial review provisions of the APA, 5 U.S.C. §§ 701-706.

As a threshold matter, the dioxin reassessment is reviewable by this court. Under the APA, there is a strong presumption in favor of judicial review. Bowen v. Michigan Academy of Family Physicians, 476 U.S. 667, 670 (1986). Courts are to take a pragmatic approach to issues of finality and reviewability. See, e.g., Abbott Labs. v. Gardner, 387 U.S. 136, 149-50 (1967); Flue-Cured Tobacco Co-op Stabilization Corp. v. United States EPA, 857 F. Supp. 1137, 1143 (M.D.N.C. 1994) (employing "a pragmatic approach, as well as a flexible view of finality"). Here, the dioxin reassessment is reviewable both as an "informational" document that is likely to have direct impact on Plaintiffs and as a policy statement used by the agency to affect legal rights.

The dioxin reassessment is judicially reviewable as an informational document. See, e.g., Synthetic Organic Chem. Mfrs. Ass'n v. Secretary, DHHS, 720 F. Supp. 1244, 1249 (W.D. La. 1989) (issuance of agency report on carcinogenicity is reviewable even though report is "informational and imposes no sanctions"); Dow Chemical v. Consumer Prod. Safety Comm'n, 459 F. Supp. 337, 386 (W.D. La. 1978) (holding government report classifying companies' chemical as suspected carcinogen was reviewable because of likely third party reactions, noting "'moral suasion' is a considerably potent force in our society.").

In a case recently decided in this district, the court reviewed a challenge to a proposed government report on dioxin similar to the report at issue here. In that case, which involved some of the same parties who are Plaintiffs in this action, the court ultimately deferred to the agency's interpretation of listing criteria not at issue here. Tozzi v. DHHS, Civ. No. 99-1170 (Sept. 30, 2000) (Sullivan, J.). The key point for purposes of this case is that Judge Sullivan reviewed the case on the merits despite the government's argument that the proposed report -- an "informational document" only -- was not reviewable.

In Flue-Cured Tobacco Cooperative Stabilization Corp. v. EPA, 857 F. Supp. 1137 (M.D.N.C.), the court held that EPA's classification of environmental tobacco smoke as a "known human carcinogen" was reviewable, even though the agency report was "informational" and no regulatory actions were "automatically" triggered. The court noted that the listing would assist other agencies in "setting priorities for action". Id. at 1142 & n.7. See also Block v. Meese 793 F.2d 1303, 1309 (D.C. Cir. 1986) (reviewing Department of Justice classification of environmental films as political propaganda where alleged injury was based on public perception).

As discussed further in section III, infra, Plaintiffs and others whose products are even alleged to contribute to environmental dioxin levels will suffer severe repercussions from EPA's release of the draft reassessment as final. Plaintiffs therefore are entitled to seek review of the report in this Court.

In addition to its effects on public perception, the dioxin reassessment will serve as a direct predicate to EPA regulatory action. EPA has used earlier draft versions of the dioxin reassessment to impose regulatory limits that have substantial effects on private parties. One frequent use is in the determination and imposition of cleanup levels under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), 42 U.S.C. § 9601, et seq. In a case now pending before the Eighth Circuit Court of Appeals, United States v. Hercules, Inc. (Civ. Nos. 99-3684, 99-3685), for example, EPA is relying on the 1994 draft dioxin reassessment (as well as the 1986 cancer guidelines) in defense of cleanup levels the agency imposed under CERCLA.

Like earlier drafts, the final dioxin reassessment, once completed, will provide a predicate for EPA's establishment, or adjustment, of permissible dioxin levels in numerous regulatory contexts. EPA officials have publicly stated, for example, that the increased cancer risks contained in the dioxin reassessment may lead to a six-fold lowering of the allowable level of dioxins in sewage sludge. See Exh. C (Risk Policy Rpt., Nov. 30, 2000 at 26). EPA has also committed to "revisiting" both Superfund cleanup standards and water quality criteria once the dioxin reassessment is finalized. See Exh. D (Risk Policy Rpt., Nov. 30, 2000 at 5).

Plaintiffs have attached as Exhibit E a copy of an April 2000⁽⁸⁾ EPA slide presentation by Dr. William H. Farland, Director of EPA's National Center for Environmental Assessment, and Dwain L. Winters, Director of the Dioxin Policy Project, Office of Pollution Prevention and Toxics. These slides set forth a 14-point agenda for expansion of current regulatory and other programs as part of the agency's "Dioxin Exposure Initiative". See Exh. E at pp. 8-10. The list specifically notes revisions to EPA's water criteria (item 9) and remedial action clean-up levels (item 10).

In addition to supporting EPA's own regulatory programs, the dioxin reassessment is intended to serve -- and will serve -- as a basis for regulatory action by third parties, including state and local regulatory agencies. The State of New Hampshire, for example, is moving to reduce dioxin releases from five sources, including medical waste, "because of EPA's recent determination that the pollutant is a 'known' carcinogen." Exh. F. ⁽⁹⁾

The fact that no particular dioxin regulation is at issue in this case does not make the case unripe, nor does it dispossess the Court of subject matter jurisdiction. The D.C. Circuit has held that a challenge to an agency "guidance" document may be ripe for review, even if the challenge is not raised in connection with a particular regulatory standard. In Appalachian Power Co. v. EPA, 208 F.3d 1015 (D.C. Cir. 2000), the court noted that the case was presented "in pure abstraction" and that the question of "[w]hich, if any, federal standards are susceptible to State revision [based on the EPA guidance] is thus something about which we can only guess." Id. at 1024. The court nevertheless reviewed the guidance and held that its promulgation was improper absent formal rulemaking procedures. Because the EPA dioxin reassessment will serve as an agency reference to determine other regulatory activity, the agency's use of the non-finalized draft cancer guidelines to support the reassessment is reviewable agency action.

2. Defendants' Use of the Cancer Guidelines Is Judicially Reviewable Under the APA.

EPA's adoption and use of formal guidelines for carcinogen risk assessments also is a final agency action, reviewable by this Court under 5 U.S.C. §§ 702, 704 and 706. The so-called "guidelines" are, in reality, final agency action, binding on EPA officials, whose use by the agency has real and legal consequences for private parties. Thus, they are judicially reviewable under the APA. See, e.g., SOCMA, supra, at 1249.

a. EPA Cannot Avoid Judicial Review By Characterizing Its Rules for Cancer Risk Assessment as "Guidelines".

EPA's characterizations of the cancer risk assessment guidelines at issue in this case as mere "guidance documents" is not dispositive on the issue of their reviewability. An agency cannot escape judicial review by labeling its actions "guidelines". Barrick Goldstrike Mines, Inc. v. EPA, 215 F.3d 45 (D.C. Cir. 2000) (EPA guidance stating that chemicals in waste rock from metal mining are not eligible for the de minimis exception in Toxic Release Inventory program was "final agency action" and ripe for judicial review); Appalachian Power, supra, at 1022; NRDC v. EPA, 22 F.3d 1125, 1132-33 (D.C. Cir. 1994); American Farm Bureau v. EPA, 121 F. Supp. 84, 105-106 (D.D.C. 2000) (science policy, which EPA characterized as "guidance", qualified as final agency action and binding rule for purposes of surviving motion to dismiss).

In Appalachian Power, supra, the court held that EPA's issuance of a "guidance" document in connection with states operating permit programs under the Clean Air Act was a final action subject to judicial review. The court held that since the document represented EPA's settled position as to states' responsibility to review state and federal emission standards, and to impose more stringent standards in the event a state found existing monitoring requirements inadequate, the document had legal consequences both for state agencies and parties subject to permit requirements. EPA's issuance of the so-called "guidance" was therefore subject to judicial review, notwithstanding the possibility that the agency might one day modify it.

Courts specifically have recognized that an agency's adoption of criteria for classifying environmental hazards are reviewable "agency action" under the APA. See, e.g., SOCMA, supra, at 1249 (agency's adoption of classification procedures and criteria for classifying chemical substances as known or reasonably anticipated carcinogens constituted reviewable "agency action" under APA); see also Troy Corp. v. EPA, 120 F.3d 277 (D.C. Cir. 1997) (holding EPA's adherence to criteria for adding substance to list of reportable chemicals under Toxics Release Inventory was reviewable agency action). Here, the agency's adoption (or nonadoption) and use of the draft cancer guidelines is similarly reviewable.

With respect to whether an agency's policy statement is "binding" on private parties, the D.C. Circuit in Appalachian Power set forth the following test:

If an agency acts as if a document issued at headquarters is controlling in the field, if it treats the document in the same manner as it treats a legislative rule, if it bases enforcement actions on the policies or interpretations formulated in the document, if it leads private parties or State permitting authorities to believe that it will declare permits invalid unless they comply with the terms of the document, then the agency's document is for all practical purposes "binding."

Appalachian Power, supra, 208 F.3d at 1021 (citing Robert A. Anthony, Interpretive Rules, Guidances, Manuals, and the Like -- Should Federal Agencies Use Them to Bind the Public?, 41 Duke L.J. 1311, 1328-29 (1992) and cases cited therein). The EPA cancer guidelines clearly satisfy the above test.

b. EPA Has Used the Cancer Guidelines to Set Binding Standards and Affect Legal Rights.

Defendants will be hard pressed to dispute the fact that EPA has used, and is still using, the cancer guidelines to set environmental standards and to make other binding regulatory decisions, with respect to both dioxin and other chemicals. In Greenpeace, Inc. v. Waste Tech. Indus., 1993 WL 134861 (N.D. Ohio Mar. 5, 1993), for example, the court noted that "Consistent with the risk assessment guidelines" EPA had assessed risk to a hypothetical maximally exposed individual in connection with proposed operation of an Ohio waste incinerator. The court noted EPA had concluded that the excess lifetime cancer risk to the hypothetical individual due to inhalation exposure of dioxin and dioxin-like compounds is 1.3 x 10^-6. Id. at *17.

The most obvious example of EPA's use of the guidelines outside the dioxin context, an example that directly concerns Plaintiffs in this case, is EPA's pesticide registration program under the Federal Insecticide Fungicide and Rodenticide Act, 7 U.S.C. § 136, et. seq. Defendants surely must admit that the agency uses the cancer guidelines in the pesticide context to establish legal rights. See Compl. Exh. 1 (Aug. 31, 2000 EPA Pesticides Program Memorandum and attached hazard descriptor chart for 1986, 1996 and 1999 cancer guidelines).⁽¹⁰⁾

The D.C. Circuit previously has characterized the cancer guidelines as a "final rule". International Fabricare Inst. v. EPA, 972 F.2d 384, 397 (D.C. Cir. 1992). When EPA has failed to follow the guidelines, in fact, the D.C. Circuit has reversed the agency action. In Chlorine Chem. Council v. EPA, 206 F.3d 1286 (D.C. Cir. 2000), a case involving a maximum contaminant level goal (MCLG) for chloroform under the Safe Drinking Water Act, the court held that the agency had acted arbitrarily and capriciously in not following the guidelines' directive regarding use of a default assumption for linear extrapolation. The court recognized EPA's obligation to apply the cancer guidelines as "the relevant rules." Id. at 1290. In its 1998 final rule on the chloroform MCLG, EPA had acknowledged that the agency "is required to use the 1986 Cancer Guidelines (EPA 1986) until the 1996 Cancer Guidelines (EPA 1996b) are formally finalized". 63 Fed. Reg. 69390, 69401 (Dec. 16, 1998).

In that the cancer guidelines indisputably constitute an agency statement of general or particular applicability and future effect designed to implement, interpret or prescribe agency policy, they clearly fall within the APA definition of "rule", 5 U.S.C. § 551(4). Plaintiffs intend to seek additional examples of the agency's use of the cancer guidelines in order to provide the Court a more comprehensive description of how the agency uses these rules for regulatory purposes.⁽¹¹⁾

3. EPA Has Neither Formally Rescinded the Final and Still Effective 1986 Cancer Guidelines nor Given any Notice to the Public That It Was Superseding the 1986 Guidelines with the 1996 or 1999 Draft Guidelines.

Defendants have never formally announced that the 1986 guidelines have been rescinded, nor have they formally stated that either the 1996 or the 1999 guidelines supersede the 1986 guidelines, which the D.C. Circuit has referred to as "final rules." International Fabricare, supra, at 397.

As noted above, when EPA published its revised proposed cancer guidelines in 1996 it stated expressly that the 1986 guidelines would remain in effect until the later guidelines were finalized. Other agency statements also indicate that EPA did not intend the 1996 proposed guidelines to supersede the 1986 guidelines until the 1996 guidelines were finalized. See, e.g., 63 Fed. Reg. 43756, 43758 (Aug. 14, 1998) (agency's "Notice of Draft Revisions to the Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health"). Significantly, only the 1986 guidelines -- not the later versions -- are referenced in the Code of Federal Regulations. See 40 C.F.R. Pt. 132 App. C (Great Lakes Water Quality Initiative Methodologies for Development of Human Health Criteria and Values) (excerpt attached as Exhibit H).

Similarly, the agency issued the 1999 draft guidelines as "Draft" only. These guidelines have never been published in the Federal Register, and EPA has never announced that it is adopting them as final. To the contrary, the 1999 draft guidelines go out of their way to disclaim that they represent final agency policy. The cover states that it is a "Preliminary Draft" and that "[i]t has not been formally released by the United States Environmental Protection Agency and should not at this stage be construed to represent Agency policy." The inside cover (p. ii) describes the draft guidelines as a "work in progress" and notes that EPA is continuing to assess recommendations from the agency's Science Advisory Board. Stamped in large type at the bottom of each page are the words "DRAFT -- DO NOT CITE OR QUOTE." See Exh. A.

4. Defendants' Use of Draft Rules in Place of Still Effective Final Rules Is Arbitrary and Capricious Agency Action under the APA.

Defendants' departure from the still final and effective 1986 guidelines without announcing formally that departure and providing a reasoned explanation is arbitrary and capricious. Moreover, the agency's inconsistent use of varying standards is further evidence of arbitrary and capricious conduct.

Courts have long held that agency action based on change in settled policy is arbitrary and capricious unless the agency formally announces the change in policy and supplies a reasoned explanation for the change of course. Motor Vehicle Mfrs. Ass'n v. State Farm, 463 U.S. 29, 57 (1983) ("an agency changing its course by rescinding a rule must supply a reasoned analysis"); Bell Atlantic Tel. Co. v. FCC, 206 F.3d 1, 8 (D.C. Cir. 2000) (vacating and remanding because of commission's failure to provide "real explanation"); Troy Corp., supra, at 286 ("Were the EPA to abandon a long-held exposure policy and take a new direction we would, as urged, require a thorough explanation of its reasons for doing so."); Sierra Club v. EPA, 719 F.2d 436, 457 (D.C. Cir. 1983) ("EPA must at least explain its rejection of alternatives with reasons that are not contradicted by the record.").⁽¹²⁾

Far from formally announcing and explaining a change in settled policy, however, EPA has done exactly the opposite. As noted above, the 1999 guidelines prominently state that they are "draft" only, and that they "should not at this stage be construed to represent Agency policy". Likewise, the agency has repeatedly stated that the 1996 guidelines will not supersede the 1986 guidelines until the 1996 guidelines are finalized. EPA is thus attempting to reverse its long-standing, final, and still effective 1986 cancer risk assessment procedures without advising the public that it is doing so, i.e., without declaring that any of the more recent guidelines are final.

It may be the case that, because the SAB has criticized the hazard descriptors and definitions in the draft guidelines and has raised other issues, EPA has simply been reluctant to finalize the guidelines in the face of such criticism. Indeed it may be difficult for EPA to provide a "reasoned" justification for its changes in the hazard descriptors and definitions in the face of SAB criticism that the proposed changes are not reasonable. Whatever the reasons for delaying finalization of the new guidelines, however, it is clear that the agency has never formally announced a final change in its pre-existing, established policy, as evidenced by the many statements on the drafts that they are preliminary, are not yet final, do not represent agency policy, are a "work in progress", and should not be quoted or cited.

EPA's disregard of its still effective final rules is arbitrary and capricious in another respect as well. At various times over the past five years the agency has conducted risk assessments by reference to at least three, and perhaps four, different and inconsistent versions of its cancer risk assessment guidelines. The recurring changes in terminology and methodology, as a result of the varying cancer risk guidelines EPA has sought to apply, have led to confusion among the regulated community, the public, and even among reviewing scientists themselves. Difficulties raised by EPA's invocation of these shifting policies were evident in the course of the dioxin reassessment. The Final Report of the Peer Review for the dioxin reassessment noted:

The reviewers' discussion was hampered by the fact that EPA has not yet finalized its 1999 "Proposed Guidelines for Carcinogenic Risk Assessment." Many reviewers wondered exactly what EPA's criteria were for characterizing cancer hazards in the Integrated Summary.

Report on the Peer Review of the Dioxin Reassessment Documents: Toxicity Equivalency Factors for Dioxin and Related Compounds (Chapter 9) and Integrated Risk Characterization Document (EPA Aug. 24, 2000) at 2-32 to 2-33 (attached as Exh. I) (emphasis added).⁽¹³⁾

The agency's admitted practice of relying on a multiplicity of inconsistent cancer guidelines is graphically demonstrated by the EPA document attached as Exhibit 1 to the complaint. The table portion of that memorandum sets forth a menu of differing guidelines from which EPA claims it may choose in performing pesticide risk assessments. Regulatory decisions that turn on such unpredictable application of inconsistent agency criteria are, by definition, arbitrary and capricious.

B. EPA's Use of Draft Rules That Were Never Submitted to Congress Violates the Congressional Review Act.

Beginning in 1996, Congress required that an agency wishing to promulgate a rule must first submit that rule to Congress for review. Codified at 5 U.S.C. § 801, et. seq., the statute commonly referred to as the "Congressional Review Act" provides, in part:

Before a rule can take effect, the Federal agency promulgating such rule shall submit to each House of the Congress and to the Comptroller General a report containing --

	(i)	a copy of the rule;
	(ii)	a concise general statement relating to the rule, including whether it is a major rule; and
	(iii)	the proposed effective date of the rule.

Although EPA refers to them as "guidelines", the cancer risk assessment guidelines are in reality statements of policy,⁽¹⁴⁾ and as such, they are clearly within the definition of "rule" under the CRA. See 5 U.S.C. § 804(3) (incorporating APA definition of "rule" under 5 U.S.C. § 551, with certain exceptions not applicable here).

While the 1986 cancer guidelines were adopted prior to the effective date of the CRA, both the 1996 and the 1999 guidelines were issued following the effective date of that statute (March 29, 1996). EPA therefore is under a statutory obligation to submit the "guidelines" to Congress and to the Comptroller General in accordance with the above law prior to using the new rules in risk assessments, including the dioxin reassessment, or other agency programs. Yet neither the 1996 nor the 1999 draft cancer guidelines were ever submitted to Congress. In using the guidelines/rules without finalizing them and submitting them to Congress, EPA is acting outside its congressionally delegated authority.

Accordingly, pursuant to that statue, neither the proposed 1996 guidelines nor the draft 1999 guidelines have yet to "take effect" under the plain language of CRA section 801(a)(1)(A). Use of the rules without submission to Congress is agency action not in accordance with law and must be set aside. 5 U.S.C. § 706(2). In that these EPA issuances are without force and effect, the Court should not permit the agency to use them as the basis for establishment of federal policy, including the forthcoming dioxin reassessment. Plaintiffs therefore request an appropriate Order from the Court immediately enjoining EPA's release of the dioxin reassessment and prohibiting EPA's use of either the 1996 or 1999 cancer risk assessment guidelines until such time as the guidelines are finalized and duly submitted to Congress as required by law.

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

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

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

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

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

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

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

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

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

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

III. EPA's Public Release of a Final Dioxin Reassessment That Places Dioxin in the Agency's Highest Carcinogen Hazard Classification and Characterizes Health Risks Dramatically Higher than Previously Estimated Threatens Plaintiffs with Imminent Irreparable Harm.

EPA is nearing completion of the dioxin reassessment, and the threat to Plaintiffs is therefore imminent. In a Federal Register notice earlier this month, EPA announced a meeting of the SAB Executive Committee for February 5-6, 2001, to review a draft of the dioxin reassessment. 66 Fed. Reg. 4824 (Jan. 18. 2001) (attached Exh. X). EPA recently posted notice on its website that the SAB Executive Committee "anticipate that the SAB Dioxin Reassessment Review Committee's (DRRC) report 'Review of EPA's Draft Exposure and Human Health Reassessment of 2,3,7,8-Tetrachlorodibenzo-p-Dioxin (TCDD) and Related Compounds' will be ready for EC review at this meeting." See Exh. L. A senior EPA official on the reassessment team has advised the trade press that the agency may be able to publicly release the report by late March, 2001, if the SAB issues its critique in early February. Exh. M (BNA Daily Envt. Rpt., Jan. 18, 2001).

If the dioxin reassessment is released as final in its current form, the report will generate enormous publicity. When a draft of the report was leaked to the press in May 2000, wire services and the mainstream press immediately carried the story nationwide. See, e.g., Exh. N. The most alarming conclusions regarding dioxin's carcinogenicity and the public's alleged risk of cancer from exposure to ordinary environmental levels of dioxin in that draft report are substantially unchanged in the report set for final release this spring.

Environmental activist groups are eagerly awaiting government support for their claims that dioxin in the environment at ordinary exposure levels poses a significant cancer threat. See Exhs. O, P, Q. These groups, including Greenaction, the Zero Dioxin Alliance, and others, can be expected to hail any new government information on the subject, particularly a report as widely disseminated as the EPA dioxin reassessment. Such groups have cited drafts of the dioxin reassessment to influence public opinion and to generate local government regulatory action. See Exhs. R, S at 4 n. 5.

Plaintiffs Brevet Industries and Brevet, Inc. (collectively, "Brevet") are likely to suffer severe and irreparable injury as a result of EPA's proposed release of the dioxin reassessment as final. Brevet's owner and President, Charles Brewer, has filed a detailed affidavit describing the threatened harm to Brevet from the publication of the dioxin reassessment as proposed. Mr. Brewer's affidavit is submitted herewith as Exhibit T.

Brevet is a small California-based business that manufactures medical connectors and similar medical equipment from polyvinyl chloride ("PVC") plastic, a substance that has been unremittingly under fire by activist groups for allegedly contributing to dioxin levels in the environment. Brevet products include disposable plastic connectors for use with PVC tubing and surgical units used during open-heart surgery. Brevet produces, as its foremost product line, both rigid polycarbonate connectors and flexible PVC connectors. Approximately five to ten percent of Brevet's total revenue comes from the sale of the flexible connectors containing PVC plastic. Exh. T at ¶ 4. More importantly, Brevet's flexible PVC connectors and its rigid polycarbonate connectors are designed to connect exclusively to flexible PVC vinyl tubing. Ex. T at ¶ 5. Virtually all (over 95 percent) of Brevet's sales depend upon the continued use of flexible PVC tubing in the medical equipment industry. Exh. T at ¶¶ 5, 10(a).

In addition to identifying dioxin as a human carcinogen and dramatically increasing the estimated risk of cancer from environmental dioxin exposure, the proposed dioxin reassessment specifically cites "medical wastes" and PVC manufacturing as sources of environmental dioxin releases. See Sept. 2000 Draft Reassessment, Part 1, Vol. 2, pp. 3-23 to 3-37, 8-16 to 8-24. Exh. U. If the dioxin reassessment were published as proposed, including a finding that dioxin is a "human carcinogen", vocal activist groups would therefore immediately trumpet the dioxin reassessment as a formal endorsement of their campaign against the use of PVC medical equipment, including Brevet's products. See Exh. V (dioxin activist paper describing "medical waste problem"); Exhs. O, W.

Brevet's participation in this lawsuit was prompted in part by recent events in Brevet's home state of California. In the past several months local authorities in three northern California municipalities have passed forceful resolutions calling for the phase out and eventual elimination of PVC plastic products. See Exhs. R, S, Y. These resolutions were all based, in part, on the EPA's conclusions regarding dioxin in the 1994 draft dioxin reassessment. The new dioxin reassessment now imminent would characterize the cancer hazard and risks, based on the draft cancer guidelines, as dramatically higher than in 1994. These municipal actions, spurred on by the activist groups noted above, seriously threaten Brevet's continued ability to sell its products in a major local market.

Brevet has already begun to feel the initial effect of this anti-PVC movement. Under pressure from shareholder groups, as well as Greenpeace and other activist organizations, one of Brevet's medical equipment customers, Baxter International, has announced its intention to develop and introduce intravenous systems that do not use PVC tubing. See Brewer Affid. (Exh. T) at Exh. 1. Other major medical equipment purchasers, including Tenet Healthcare, Universal Health Services, Kaiser Permanente and Catholic Healthcare West have indicated they will follow Baxter's lead and shift away from PVC tubing. Id.

The EPA dioxin reassessment is a widely publicized formal determination and carries the imprimatur of the nation's foremost environmental agency. Statements in that document concluding that (i) dioxin is a "human carcinogen" (ii) the risk of cancer from exposure to environmental dioxin at ordinary levels is dramatically greater than had previously been reported and (iii) significant sources of dioxin include "medical waste" and PVC manufacturing, will lead directly to the adverse public reaction, regulatory initiatives, and purchaser de-selections described above. Brevet therefore stands to suffer significant adverse economic harm if the dioxin reassessment is published as proposed.

In a separate lawsuit relating to another federal agency's proposed publication of a report reaching a similar conclusion on dioxin carcinogenicity, the District Court for the District of Columbia held on September 30, 2000, that Plaintiff Brevet had standing to bring an action for declaratory and injunctive relief. Tozzi v. DHHS, D.D.C. Civ. No. 99-1170 (Sullivan, J.). Plaintiffs anticipate that Defendants may challenge Brevet's standing to participate in this lawsuit as well. As the discussion above concerning irreparable harm demonstrates, however, the district court in the DHHS case was correct to reject the government's standing argument with respect to Plaintiff Brevet.⁽¹⁵⁾

IV. The Balance of Interests Between the Parties, As Well As the Public Interest, Clearly Support the Issuance of a Preliminary Injunction.

EPA's failure to issue final cancer risk assessment guidelines, even after prolonged delay, reflects uncertainty as to whether the various drafts are scientifically supportable (in other words, whether they are "reasonable" in a scientific sense). Had the SAB approved of either the proposed 1996 or the draft 1999 guidelines, EPA would likely have issued one (or perhaps both) versions as final. In the face of the agency's own demonstrated uncertainty, the Court must seriously question the benefit of releasing the dioxin reassessment itself, which is based on these non-finalized guidelines.

The final dioxin reassessment will be an extremely important and highly publicized document, as evidenced by the obvious media interest in even a draft version. The public would be ill served by premature release of a risk assessment whose underpinnings (i.e., the draft cancer risk assessment guidelines) are considered by the agency as unworthy of being finalized. The scientific credibility of such an important document is too critical.

On the other hand, there is the very real concern of the Plaintiffs that release of the risk assessment with this likely flawed underpinning would cause them, and others similarly situated, irreparable and unjustified harm. The draft reassessment, as currently written and if finalized, would indict the PVC medical devices Plaintiff Brevet manufactures as possible sources of dioxin in the environment. The balance of interests here thus clearly favors the Plaintiffs.

The public has a right to know about risks, but it also has a right to have accurate, scientifically sound information. To disseminate to the public flawed information would certainly be a disservice.

For the foregoing reasons, Plaintiffs' application for a preliminary injunction should be granted.