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IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
CIVIL DIVISION

 

JIM J. TOZZI
          8995 Kildownet Court
          Vienna, Virginia 22182,

DIATECT INTERNATIONAL CORP.1134 N.
          Orchard, Suite 206
          Boise, Idaho 83706,

                    and

BREVET INDUSTRIES and BREVET, INC.,
          16661 Jamboree Blvd.
          Irvine, CA 92606-5118,

                              Plaintiffs,

                    v.

UNITED STATES ENVIRONMENTAL
PROTECTION AGENCY; CAROL
BROWNER, Administrator, U.S. EPA;
SUSAN H. WAYLAND, Acting Assistant
Administrator for Prevention, Pesticides,
and Toxic Substances, U.S. EPA; MARCIA
E. MULKEY, Director, Office of Pesticide
Programs, U.S. EPA; and NORINE E.
NOONAN, Assistant Administrator for
Research and Development, U.S. EPA,

                              Defendants.            

 Civil Action No. _________
 Judge_________________

COMPLAINT SEEKING DECLARATORY
AND INJUNCTIVE RELIEF

INTRODUCTION

  1. This action seeks declaratory and injunctive relief against the Defendants, the U.S. Environmental Agency ("EPA" or "agency") and key EPA officials, for their use of draft cancer risk assessment guidelines in performing human carcinogen hazard classification and risk assessments for certain environmental chemicals. The hazard classification and risk assessments at issue include a review of the pesticide pyrethrins, which EPA undertook pursuant to the Federal Insecticide, Fungicide and Rodenticide Act, 7 U.S.C. § 136, et seq. ("FIFRA"), and a forthcoming EPA final reassessment of 2,3,7,8 tetrachlorodibenzo-p-dioxin ("dioxin"). EPA improperly has used, and/or is using, draft cancer risk assessment guidelines as a basis for these hazard classifications and risk assessments, rather than the final and still effective guidelines for such reviews which the agency has promulgated.
  2. EPA promulgated the currently effective cancer risk assessment guidelines through rulemaking in 1986, after public notice and comment. 51 Fed. Reg. 33992 (Sept. 4, 1986) ("1986 guidelines"). The final 1986 guidelines differ significantly from the draft cancer guidelines at issue in this suit. The more recent draft guidelines, for example, allow placement of substances into the higher cancer hazard categories on the basis of less scientific evidence than would be required under the 1986 guidelines.
  3. The draft agency guidelines at issue include, but are not limited to, EPA’s Proposed Guidelines for Carcinogen Risk Assessment, 61 Fed. Reg. 17960 (April 10, 1996) ("1996 draft guidelines" or "1996 draft cancer guidelines"). While Defendants refer to these risk assessment policies as "guidelines," they are in fact statements of general applicability and future effect designed to implement, interpret or prescribe agency policy, and are otherwise "rules" under section 551(4) of the Administrative Procedure Act ("APA"), 5 U.S.C. §§ 551, et seq.1 Defendants are routinely violating the APA by using draft cancer risk assessment guidelines in connection with hazard classifications and risk assessments for pesticides, herbicides and other substances, including the dioxin reassessment at issue in this case.
  4. The 1986 guidelines and the later draft versions of the guidelines all require classification of substances into separate cancer hazard categories. The guidelines -- both final and draft -- all provide names or "hazard descriptors" for each category, such names purporting to correspond to the level of scientific certainty associated with each chemical’s carcinogenic potential. The 1986 guidelines’ hazard categories and corresponding descriptors are as follows:

    "Group A -- Carcinogenic to Humans"
    "Group B -- Probably Carcinogenic to Humans"
    "Group C -- Possibly Carcinogenic to Humans"
    "Group D -- Not Classifiable as to Human Carcinogenicity"
    "Group E -- Evidence of Non-Carcinogenicity for Humans"

    51 Fed. Reg. 33992, 33996 (Sept. 24, 1986).

  5.  The 1996 draft guidelines proposed to revise the above hazard descriptors and adopt the following hazard descriptors:

    "Known/Likely"
    "Cannot Be Determined"
    "Not Likely"

    61 Fed. Reg. 17960, 17985-86 (April 23, 1996).

  6. The 1996 draft guidelines also include proposed new criteria for classifying substances within the new carcinogen categories. These criteria differ substantially from the criteria contained in the still effective 1986 guidelines. In particular, less evidence of carcinogenicity is required for the known/likely category in the 1996 draft guidelines, and substances that would have been classified as "not classifiable" or as "possible" under the 1986 final guidelines can be classified as "known/likely" under the 1996 draft guidelines.
  7. The 1996 draft guidelines were proposed but never promulgated as final.
  8. In 1999 EPA generated another set of revised draft cancer risk assessment guidelines ("1999 draft guidelines" or "1999 draft cancer guidelines"). The 1999 draft guidelines differ significantly from both the 1986 guidelines and the 1996 draft guidelines. They include, for example, new cancer hazard descriptors -- or classifications -- that do not exist in either the 1986 guidelines or the 1996 draft guidelines. The hazard categories under the 1999 draft guidelines are:

    "Carcinogenic to humans"
    "Likely to be carcinogenic to humans"
    "Suggestive evidence of carcinogenicity, but not sufficient to
    assess human carcinogenic potential"
    "Data are inadequate for an assessment of human carcinogenic
    potential"
    "Not likely to be carcinogenic to humans"
  9. Under the 1999 draft guidelines a substance may be classified in the highest cancer classification, "carcinogenic to humans", based on a "weight of the evidence" approach. In contrast to the 1986 guidelines, which require that human cancer causation be demonstrated by reference to sufficient epidemiologic evidence alone before a substance is placed into the highest category, the 1999 draft guidelines permit such classifications to be based on insufficient epidemiological evidence in conjunction with animal and mode of action evidence.
  10. EPA has not published the 1999 draft guidelines in the Federal Register for public notice and comment, and it has not published them as final. The 1999 draft guidelines state on their cover:

DRAFT
DO NOT CITE OR QUOTE

* * *

THIS DOCUMENT IS A PRELIMINARY DRAFT. 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.

  1. Both the 1996 draft guidelines and the 1999 draft guidelines are "rules" as defined by the Administrative Procedure Act, 5 U.S.C. §551(4). Notwithstanding the above disclaimers in the 1999 draft guidelines, EPA has used both the 1996 and the 1999 draft guidelines as the basis for agency risk assessments. Both the 1996 draft guidelines and the 1999 draft guidelines thus constitute statements of general applicability and future effect that are designed to implement, interpret, or prescribe EPA policy. EPA’s use of the 1996 and/or 1999 draft guidelines in the cancer hazard classifications and risk assessments described below therefore violates the APA because the draft guidelines have not been promulgated as final rules.
  2. EPA’s failure to explain which set of cancer risk assessment guidelines, or combination(s) thereof, will be used during agency risk assessments leaves Plaintiffs and the regulated community without fair notice or knowledge of Defendants’ risk assessment policies and procedures. The draft guidelines constitute clear evidence of arbitrary and capricious agency conduct, because EPA has failed to provide the regulated community with clear standards by which the agency will assess carcinogen risk. An August 31, 2000, memorandum from the Science Analysis Branch Chief of EPA’s Health Effects Division to the Director of the Health Effects Division sets forth, in table format, the multiple and conflicting sets of guidelines that EPA claims it may or may not apply during the agency’s cancer risk assessments. See Exhibit 1, attached hereto, at 2-6.
  3. As described more fully below, in addition to violating the APA, EPA has also violated the Congressional Review Act, 5 U.S.C. 801-808, by giving effect to rules which it has not finalized and submitted to Congress and the Comptroller General.

JURISDICTION AND VENUE

  1. This Court possesses federal question subject matter jurisdiction pursuant to 28 U.S.C.§ 1331, and has authority to review this matter and grant the relief requested pursuant to the Declaratory Judgment Act, 28 U.S.C. §§ 2201-2202, and the Administrative Procedure Act, 5 U.S.C. §§ 701-706. Defendants’ sovereign immunity is waived under the APA, 5 U.S.C. §§ 702-703.

  2. Venue is proper in this judicial district under 28 U.S.C. § 1391, because a substantial portion of the actions or omissions giving rise to the causes of action occurred or failed to occur at EPA headquarters in the District of Columbia.

  3. Defendants’ classification of pyrethrins as a "likely" human carcinogen is a final agency action within the meaning of APA sections 704 and 706. Plaintiffs have no other adequate remedy in a court.

  4. Defendants’ classification of dioxin as a "human carcinogen" or "carcinogenic to humans" under draft rules is a final agency action within the meaning of APA sections 704 and 706. Drafts of the EPA dioxin reassessment have already been used in the regulatory context, including Superfund site risk assessments and remedial action decisions. The release of the classification in final form is imminent, and Plaintiffs will have no opportunity to challenge the legality of the agency’s action before the report is published as final. Plaintiffs have no other adequate remedy in a court.

  5. Defendants’ violation of the Congressional Review Act, as described more fully below, is a final agency action within the meaning of the APA.

  6. Plaintiffs’ allegations and claims present a justiciable controversy within the meaning of Article III, section 2, clause 1 of the United States Constitution, and an actual controversy within the meaning of the Declaratory Judgment Act. The facts of the controversy have been fully developed, allowing entry of judgment and ordering of relief that will resolve the controversy between Plaintiffs and Defendants.

THE PARTIES

  1. Plaintiff Tozzi is a resident of the Commonwealth of Virginia. Plaintiff Tozzi and his wife are purchasers and consumers of pyrethrin-containing products, including pet shampoo and garden and house plant insecticides. Defendants’ action threatens the continued availability of such products.

  2. Plaintiff Diatect International Corporation ("Diatect") is a publicly traded California corporation organized in May, 1979, with its principal place of business in Boise, Idaho. Diatect manufactures and sells "environmentally-friendly" insecticide products for home and garden, pet care, and agricultural use under the name "Diatect Insecticides" and the company’s trade name, "ResultsTM". All of Diatect’s products contain pyrethrins, a botanical extract. Operation of Diatect’s plant facility, which is located in Lebanon, Kansas, is handled through a wholly owned subsidiary, Diatect International, Inc.

  3. Plaintiffs Brevet Industries and Brevet, Inc. (collectively, "Brevet" or "the PVC Plaintiffs") are privately held California corporations, whose principal place of business is located in Irvine, California. Brevet manufactures medical products that contain polyvinyl chloride ("PVC"), including flexible plastic connectors for use in blood transfusions, surgery and other medical procedures. The manufacturer of PVC products and the incineration of PVC medical waste have been alleged to contribute to dioxin levels in the environment.

  4. Defendant EPA is the principal federal agency responsible for protecting the environment and for regulating herbicides and pesticides under FIFRA. EPA also has responsibility for protecting environmental health and safety.

  5. Defendant Carol Browner is the current EPA Administrator. In her official role, she is ultimately responsible for all EPA actions.

  6. Defendant Susan H. Wayland is the Acting Assistant Administrator for EPA’s Office for Prevention, Pesticides, and Toxic Substances. In her official role, she is in charge of the EPA Division that includes the Office that regulates pesticides and herbicides under FIFRA.

  7. Defendant Marcia E. Mulkey is Director of EPA’s Office of Pesticide Programs. In her official role, she is in charge of the EPA Office that regulates herbicides and pesticides under FIFRA.

  8. Defendant Norine E. Noonan is EPA’s Assistant Administrator for Research and Development. In her official role, she is one of the lead officials in charge of the EPA dioxin reassessment described herein.

DEFENDANTS’ USE OF DRAFT CANCER GUIDELINES
FOR THE PYRETHRINS CANCER CLASSIFICATION,
IN VIOLATION OF THE APA

  1. Plaintiffs incorporate by reference the allegations contained in the preceding paragraphs of this Complaint.

  2. In 1986, after providing public notice and opportunity to comment, EPA promulgated final rules governing cancer risk assessments in all EPA proceedings. 51 Fed. Reg. 33992 (Sept. 24, 1986).

  3.  On April 23, 1996, EPA proposed for public comment revisions to the 1986 cancer risk assessment guidelines. The 1996 draft guidelines differ significantly from the 1986 guidelines. In the preamble published in the Federal Register, the 1996 draft guidelines stated, "When final, these guidelines will replace the 1986 guidelines." The 1996 draft guidelines have never been promulgated as final rules.

  4. Upon information and belief, EPA has applied either the 1996 draft guidelines or the 1999 draft guidelines in numerous carcinogen risk assessment proceedings, including over 40 herbicide or pesticide reviews or registrations under FIFRA.

  5. Plaintiffs include a manufacturer/distributor and a consumer of pesticide products that contain the active ingredient pyrethrins. Pyrethrins are oily liquid esters refined from flowers of the chrysanthemum family, commonly known as the "African Daisy".

  6. In February 1995, EPA attempted to classify pyrethrins under the 1986 final guidelines. At that time EPA decided to defer cancer classification of pyrethrins pending further review of animal test data.

  7. In February 1999, Defendant EPA’s Cancer Assessment Review Committee ("CARC"), a body within the Health Effects Division of EPA’s Office of Pesticides Programs, conducted a review of pyrethrins. The CARC inappropriately used the 1996 draft guidelines to assess and classify the carcinogenic potential of pyrethrins. Following this review, the CARC concluded that pyrethrins were "likely to be a human carcinogen by the oral route." A true and correct copy of the CARC report, dated April 8, 1999, is attached hereto, with two related EPA cover letters, as Exhibit 2.

  8. Although the CARC classified pyrethrins as "likely to be a human carcinogen by the oral route", the April 8, 1999, CARC report also concluded, "Since there are no carcinogenicity studies by other routes of exposure, pyrethrins are assumed to be carcinogenic by these other routes." Exh. 2 at vi (handwritten page "9").

  9. The CARC makes final decisions on cancer classifications for EPA’s pesticides program, and it did so with respect to pyrethrins in 1999. The CARC’s evaluation of pyrethrins dated April 8, 1999, was denominated a "FINAL REPORT". Exh. 2 at handwritten page "4". An August 31, 2000, memorandum from the Chief of the Science Analysis Branch in EPA’s Health Effects Division to the Director of the Health Effects Division also describes the pyrethrins listing as the "‘final’ OPP classification." Exh. 1 at 1. The CARC pyrethrin classification decision and its subsequent report thus constitute final agency action.

  10. EPA has published its new hazard classification for pyrethrins on the EPA Internet website and has made agency documents reflecting the pyrethrin cancer classification available to the public.
  11. Had EPA continued to use the duly promulgated 1986 guidelines when it examined pyrethrins in 1999, it would not have concluded that pyrethrins should be classified as "likely" human carcinogens.

  12. EPA’s classification of pyrethrins as "likely" human carcinogens has been noted by certain "pesticide watchdog" and other activists groups, and by state authorities. These groups have placed the EPA classification information on the Internet in a context designed to convince the public that such substances are toxic and unsafe. Two examples of Internet postings referencing EPA’s conclusion that pyrethrins are "likely" human carcinogens are attached hereto as Exhibits 3 (at 1) and 4 (at 14-15). Upon information and belief, the activist groups are taking additional steps to publicize EPA’s conclusion that pyrethrins are "likely" human carcinogens and to discourage use of pyrethrins by the public.

  13. Plaintiffs have suffered and will suffer economic and other harm as a result of the wrongful application of the new draft cancer guidelines to pyrethrins, and the resulting classification of pyrethrins into the category "likely" human carcinogen. Plaintiff Diatect, for example, depends on promoting its pyrethrins products as safe. Diatect is reasonably concerned that classification of its products as likely human carcinogens will cause it serious and irreparable harm.

  14. Defendants’ action in utilizing draft rules in connection with the pyrethrins review, rather than the final rules which are still in effect, is action that is arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law.

  15. Unless and until EPA formally promulgates its new draft cancer guidelines as final rules, Defendants may not use or rely upon the draft guidelines during agency cancer review proceedings, including reviews of pyrethrins and other pesticides under FIFRA, and instead Defendants are required to use the currently effective 1986 guidelines.

  16. In the event that EPA were to undertake a new reassessment of pyrethrins, EPA would attempt to base its pyrethrins reassessment on either the 1999 draft guidelines or the 1996 draft guidelines, or some combination of the two. In any event, Plaintiffs would be unaware of the reassessment until the process was completed and would be unable to seek timely relief.

DEFENDANTS’ USE OF DRAFT CANCER GUIDELINES FOR
THE DIOXIN REASSESSMENT, IN VIOLATION OF THE APA

  1. Plaintiffs incorporate by reference the allegations contained in the preceding paragraphs of this Complaint.

  2. EPA is nearing completion of a final assessment of dioxin health risks, including a review of dioxin’s carcinogenic potential. The current draft of the dioxin report is entitled, "Exposure and Human Health Reassessment of 2,3,7,8-Tetrachlorodibenzo-p-Dioxin (TCDD) and Related Compounds".

  3. EPA is using the 1999 draft cancer guidelines in the dioxin reassessment to support the agency’s conclusion that dioxin should be placed in the highest carcinogen category. A draft of the reassessment states that its conclusion regarding dioxin carcinogenic potential is based on "the weight of all the evidence (human, animal, mode of action)". EPA released a draft of the final report earlier this year, and the report was severely criticized in the scientific community. An independent peer review committee, which met after reviewing the report in July, 2000, was also sharply critical of EPA’s conclusions.

  4. Defendants’ action in utilizing draft rules in connection with the dioxin reassessment, rather than the final 1986 guidelines which are still in effect, is action that is arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law.

  5. Had EPA used the currently effective 1986 guidelines in connection with the dioxin reassessment, EPA could not have concluded that dioxin is "best characterized as a ‘human carcinogen’". The epidemiological evidence alone is not sufficient to support a causal relationship between dioxin exposure and cancer in humans. Only by resorting to other evidence, which is permitted under the 1999 draft guidelines but which is disallowed under the 1986 guidelines, could the agency conclude that the highest level carcinogenic classification was warranted.

  6. Plaintiff Brevet stands to suffer irreparable harm if the threatened EPA dioxin reassessment is published as final. Environmental and other activist groups have alleged that the manufacture and disposal of PVC leads to increased levels of environmental dioxin exposure and that PVC products must be eliminated. These groups will trumpet the EPA dioxin findings in the media and elsewhere in an effort to discourage PVC use. Brevet, which manufactures surgical connectors from PVC, will suffer severe economic harm from lost sales and damage to business reputation.

  7. 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. (D.D.C. Civ. No. 99-1170) (Sullivan, J.).

  8. Notwithstanding the significant scientific concerns raised with EPA’s dioxin reassessment, Defendants intend to publish the dioxin report in final form before a new Administration takes office early in 2001. William H. Farland, Director of EPA’s National Center for Environmental Assessment, has made statements to this effect in the trade media.

  9. Plaintiffs will have no way of knowing exactly when Defendants will issue the dioxin reassessment in final form. In light of the near completion of EPA’s internal review process and the high level EPA statements regarding the agency’s intention to publish the report before the next Administration takes office, however, it is unlikely that Plaintiffs would be able to obtain timely pre-publication relief from this Court if this suit is delayed. Once the report is released in final form, the harm to Plaintiffs will be unavoidable and irreparable. Plaintiffs’ request for relief is therefore timely at this point.


DEFENDANTS’ VIOLATION OF THE
CONGRESSIONAL REVIEW ACT

  1. Plaintiffs incorporate by reference the allegations contained in the preceding paragraphs of this Complaint.

  2. In 1996 Congress adopted new procedures for congressional review of agency rules. The provisions were included in a separate congressional review title of H.R. 3136, the Small Business Regulatory Enforcement Fairness Act of 1996, Pub. L. No. 104-121, 110 Stat. 847. The provisions added a new chapter to the APA and are codified at 5 U.S.C. Chapter 8. This new chapter has come to be known as the "Congressional Review Act" (or "CRA") and is referred to as such in this Complaint.

  3. Section 801(a)(1) of the CRA provides that, "[b]efore an agency rule can take effect", the agency promulgating the rule must submit to each House of Congress a copy of the rule, a concise statement of the rule’s effect, and the proposed effective date. That section also requires the agency to submit further detail regarding the rule to the Comptroller General and make such detail available to Congress.

  4. Under section 802 of the CRA, Congress may, within 60 days after submission of an agency rule under section 801, issue a joint resolution declaring that the rule shall have no force or effect.

  5. Both the 1996 and the 1999 EPA draft cancer guidelines are statements of general EPA policy. Accordingly, both the 1996 and 1999 draft cancer guidelines are non-final "rules" as defined under section 804 of the CRA.

  6. Notwithstanding the requirements of the CRA, EPA has never submitted either the 1996 or the 1999 draft cancer guidelines to Congress and the Comptroller General for review. The 1996 and 1999 draft cancer guidelines thus have not legally taken effect.

  7. Accordingly, the 1996 and 1999 draft cancer guidelines should be declared without force and effect, and EPA should be judicially precluded from utilizing the draft guidelines in connection with agency risk assessments, including the pyrethrin and dioxin reviews at issue in this suit.

FIRST CAUSE OF ACTION:
ARBITRARY AND CAPRICIOUS AGENCY ACTION IN
FAILING TO APPLY THE AGENCY’S OWN FINAL AND

PUBLISHED RULES DURING THE PYRETHRINS REVIEW

  1. Plaintiffs re-allege and incorporate by reference herein all of the statements, allegations, and claims set forth in the preceding paragraphs of this Complaint.

  2. Defendants the United States Environmental Protection Agency and Carol Browner, through their delegated representatives, Defendants Wayland and Mulkey, failed to use the 1986 cancer guidelines in connection with the review of the carcinogenic potential of pyrethrins in 1999. As set out previously in this Complaint, Defendants’ use of the 1996 draft cancer guidelines constituted conduct that was arbitrary, capricious, an abuse of discretion, not in accordance with law, and without observance of procedure required by law. Had Defendants used the still effective 1986 cancer guidelines, EPA could not have concluded that pyrethrins are a "likely" human carcinogen.

SECOND CAUSE OF ACTION:
ARBITRARY AND CAPRICIOUS AGENCY ACTION IN
FAILING TO APPLY THE AGENCY’S OWN FINAL AND

PUBLISHED RULES DURING THE DIOXIN REASSESSMENT

  1. Plaintiffs re-allege and incorporate by reference herein all of the statements, allegations, and claims set forth in the preceding paragraphs of this Complaint.

  2. Defendants the United States Environmental Protection Agency and Carol Browner, through their delegated representative, Defendant Noonan, have failed, and are failing, to use the 1986 cancer guidelines in connection with the dioxin reassessment. As set out previously in this Complaint, Defendants’ use of the 1996 and/or 1999 draft cancer guidelines constitutes conduct that is arbitrary, capricious, an abuse of discretion, not in accordance with law, and without observance of procedure required by law. Were Defendants to use the still effective 1986 cancer guidelines, EPA could not conclude that dioxin is a "human carcinogen" or "carcinogenic to humans."

THIRD CAUSE OF ACTION:
FAILURE TO COMPLY WITH CONGRESSIONAL REVIEW ACT
REQUIREMENTS FOR SUBMISSION OF FINAL RULES TO

CONGRESS AND COMPTROLLER GENERAL

  1. Plaintiffs re-allege and incorporate by reference herein all of the statements, allegations, and claims set forth in the preceding paragraphs of this Complaint.

  2. Defendants the United States Environmental Protection Agency and Carol Browner failed to submit either the 1996 or the 1999 draft cancer risk assessment guidelines to Congress and the Comptroller as required under section 801 of the Congressional Review Act. Accordingly, these draft guidelines have not taken effect, and the agency actions taken in reliance on them should be adjudged null and void.

FOURTH CAUSE OF ACTION:
ARBITRARY, CAPRICIOUS AND UNLAWFUL AGENCY ACTION
IN APPLYING RULES THAT HAD FAILED TAKE EFFECT

UNDER TERMS OF THE CONGRESSIONAL REVIEW ACT

  1. Plaintiffs re-allege and incorporate by reference herein all of the statements, allegations, and claims set forth in the preceding paragraphs of this Complaint.

  2.  In connection with both the pyrethrin review and the dioxin reassessment, Defendants the United States Environmental Protection Agency and Carol Browner, through their delegated representatives, Defendants Wayland, Mulkey and Noonan, improperly applied, and are applying, draft cancer guidelines that have not taken effect. As set out previously in this Complaint, Defendants’ use of the 1996 and/or 1999 draft cancer guidelines constitutes conduct that is arbitrary, capricious, an abuse of discretion, not in accordance with law, and without observance of procedure required by law.

PRAYER FOR RELIEF

Plaintiffs request the following relief on their claims:

(1) A declaratory judgment stating that EPA’s use of the 1996 draft guidelines to classify pyrethrins as "likely" human carcinogens in 1999 violated the APA;

(2) Injunctive relief directing that Defendants take action, in the form of an agency press release, affirmatively disavowing the 1999 classification of pyrethrins as a "likely" human carcinogen;

(3) A declaratory judgment stating that EPA’s use of the 1996 and/or 1999 draft cancer guidelines in connection with the dioxin reassessment violates the APA;

(4) An injunction barring EPA from releasing any version of the dioxin reassessment now underway that is based on the 1996, 1999 or any other draft cancer risk assessment guidelines;

(5) An injunction barring EPA from using the 1996, 1999 or any other draft cancer risk assessment guidelines in connection with reviews of pyrethrin, dioxin or other chemicals or substances unless and until EPA rescinds the 1986 guidelines and promulgates such draft guidelines as final rules in accordance with the requirements of the APA and the Congressional Review Act;

(6) A judicial declaration that EPA failed to comply with the requirements of the Congressional Review Act by failing to submit the 1996 and 1999 draft guidelines to Congress for review as final rules and, accordingly, that agency actions taken pursuant to the 1996 and 1999 draft cancer risk assessment guidelines are null and void;

(7) An injunction barring EPA from using either the 1996 or 1999 draft cancer risk assessment guidelines unless and until Defendants fulfill the statutory requirements of the CRA; and

(8) Such other and further relief as the Court deems just and appropriate.

 

Respectfully submitted,

 


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

Attorneys for Plaintiffs

Dated: October 27, 2000


 


End Notes:
1 Plaintiffs' adaptation and use herein of Defendants' term "guidelines" does not imply an admission that the draft cancer guidelines are not, in fact, "rules" under the APA. (back to text ^)