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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.
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Civil Action No. _________
Judge_________________ |
COMPLAINT SEEKING
DECLARATORY
AND INJUNCTIVE RELIEF
INTRODUCTION
- 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.
- 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.
- 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.
- 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).
- 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).
- 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.
- The 1996 draft guidelines were
proposed but never promulgated as final.
- 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"
- 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.
- 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.
- 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.
- 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.
- 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
-
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.
-
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.
-
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.
-
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.
-
Defendants’
violation of the Congressional Review Act, as described more fully below, is
a final agency action within the meaning of the APA.
-
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
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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.
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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.
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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.
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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.
-
Defendant Carol
Browner is the current EPA Administrator. In her official role, she is
ultimately responsible for all EPA actions.
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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.
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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.
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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
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Plaintiffs incorporate
by reference the allegations contained in the preceding paragraphs of this
Complaint.
-
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).
-
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.
-
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.
-
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".
-
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.
-
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.
-
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").
-
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.
- 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.
-
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.
-
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.
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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.
-
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.
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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.
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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
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Plaintiffs incorporate
by reference the allegations contained in the preceding paragraphs of this
Complaint.
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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".
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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.
-
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.
-
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.
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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.
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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.).
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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.
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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
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Plaintiffs incorporate
by reference the allegations contained in the preceding paragraphs of this
Complaint.
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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.
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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.
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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.
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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.
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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.
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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
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Plaintiffs re-allege
and incorporate by reference herein all of the statements, allegations, and
claims set forth in the preceding paragraphs of this Complaint.
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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
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Plaintiffs re-allege
and incorporate by reference herein all of the statements, allegations, and
claims set forth in the preceding paragraphs of this Complaint.
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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
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Plaintiffs re-allege
and incorporate by reference herein all of the statements, allegations, and
claims set forth in the preceding paragraphs of this Complaint.
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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
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Plaintiffs re-allege
and incorporate by reference herein all of the statements, allegations, and
claims set forth in the preceding paragraphs of this Complaint.
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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.
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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 ^)
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