SYNGENTA CROP v. US ENVIRO. PROTECT., et al

Filing 389

MEMORANDUM OPINION signed by JUDGE N. C. TILLEY, JR on 8/9/11; that for the reasons stated, Sipcam's motion for summary judgment on Syngentas claim of arbitrary and capricious agency action in violation of the Administrative Procedure Act [Dock. 308 ], which Drexel joins, is GRANTED, that Drexels motion for summary judgment on Syngentas claim of EPA action in violation of the Equal Protection Clause and violation of FIFRAs exclusive use provisions [Dock. 312 ], which Sipcam joins, is GRANTED, that EPAs motion for summary judgment on all Counts [Dock. 316 ] is GRANTED, that MANAs motion to dismiss for lack of subject matter jurisdiction [Dock. 317 ], which Sipcam and Drexel join, is GRANTED IN PART AND DENIE D IN PART, that Syngentas motion for summary judgment on all Counts [Dock. 319 ] is DENIED, and that MANAs motion to unseal its motion to dismiss and memorandum in support of its motion to dismiss [Dock. 342 ] is GRANTED. (Welch, Kelly)

IN THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF NORTH CAROLINA
SYNGENTA CROP PROTECTION, INC.,
Plaintiff,
v.
UNITED STATES ENVIRONMENTAL
PROTECTION AGENCY,
LISA P. JACKSON,
Administrator,
U.S. Environmental Protection Agency,
MAKHTESHIM-AGAN OF
NORTH AMERICA, INC.,
SIPCAM AGRO USA, INC.
DREXEL CHEMICAL COMPANY, and
AGAN CHEMICAL
MANUFACTURERS, LTD.
Defendants.

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1:02CV00334

MEMORANDUM OPINION
I. Procedural Posture
This case is before the Court on several outstanding motions, all of which
will be addressed in this Opinion. The outstanding motions are Sipcam Agro USA,
Inc.’s (“Sipcam”) Motion for Summary Judgment on Syngenta’s Claim of Arbitrary
and Capricious Agency Action in Violation of the Administrative Procedure Act
[Dock. 308], Drexel Chemical Company’s (“Drexel”) Motion for Summary

Judgment on Syngenta’s Claim of EPA Action in Violation of the Equal Protection
Clause and Violation of FIFRA’s Exclusive Use Provisions [Dock. 312], United
States Environmental Protection Agency’s and Lisa P. Jackson’s (collectively
“EPA”) Motion for Summary Judgment [Dock. 316], Makhteshim-Agan of North
America, Inc.’s (“MANA”1) Motion to Dismiss for Lack of Subject Matter
Jurisdiction [Dock. 317], Syngenta Crop Protection, Inc.’s (“Syngenta”2) Motion
for Summary Judgment [Dock. 319], and MANA’s Motion to Unseal MANA’s
Motion to Dismiss for Lack of Subject Matter Jurisdiction and Memorandum of Law
in Support [Dock. 342]. Drexel and Sipcam join MANA’s motion to dismiss; Drexel
joins Sipcam’s motion for summary judgment; and Sipcam joins Drexel’s motion for
summary judgment. The private Defendants (collectively “Metolachlor
Registrants”) and EPA present overlapping arguments in their motions and
accompanying briefs, while Syngenta’s response briefs and own motion and
accompanying brief offer related arguments. As a result, all motions can
effectively be resolved together in one Opinion. For the following reasons,
Sipcam’s motion for summary judgment, which Drexel joins, is granted; Drexel’s

1

MANA is substituted for Cedar Chemical Company. In February 2003, EPA
approved the transfer of Cedar’s metolachlor registrations and pending applications
to MANA. See Syngenta Crop Protection Inc. v. U.S. E.P.A., 222 F.R.D. 271, 277
(M.D.N.C. 2004).
2

Syngenta is the successor-in-interest to Novartis Crop Protection, Inc. and
to Ciba-Geigy Crop Protection, Inc. This Opinion refers to this group’s collective
interest as “Syngenta.”
2

motion for summary judgment, which Sipcam joins, is granted; EPA’s motion for
summary judgment is granted; MANA’s motion to dismiss, which Sipcam and
Drexel join, is granted in part and denied in part; Syngenta’s motion for summary
judgment is denied; and MANA’s motion to unseal is granted.
II. Facts
This Court has previously explained the relevant portions of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the background of this
case in its previous opinions and will not restate those here except where
necessary. See, e.g., Mem. Op., Aug. 8, 2006 [Dock. 249]; Mem. Op., July 12,
2004 [Dock. 126].
Metolachlor was first registered in 1976 for general weed control.
Administrative Record [hereinafter “AR”] 7 at 6. In the early 1990's, EPA
developed a reduced risk initiative with two basic objectives: (1) to create
incentives for the development, registration, and use of lower risk pesticides and
(2) to encourage the replacement of higher risk pesticides on the market. AR 3. In
the meantime, EPA issued Data Call-Ins (DCIs) to then-current metolachlor
registrants, including Syngenta, for the submission of data to maintain the
registrations. AR 4-6; see 7 U.S.C. § 136a(c)(2)(B) (explaining EPA’s authority to
require additional data to maintain registrations). However, the registrants did not
submit the required data. AR 211 at 3. Although this resulted in data gaps, EPA
did not cancel the metolachlor registrations. Id. In 1995, EPA issued its 37
3

Reregistration Eligibility Decision (RED) for metolachlor according to which it found
that, with few exceptions, most uses of metolachlor would not cause unreasonable
risk to humans or the environment. AR 7 at v.
In 1996, under EPA’s reduced risk initiative, Syngenta submitted its
application for s-metolachlor which used, in part, bridging data from studies
submitted for metolachlor’s registration. AR 291 at 1; AR11; see also 7 U.S.C.
136a(c)(10) (explaining expedited registration of pesticides). According to the
application, s-metolachlor is as effective at weed control as metolachlor when
applied at approximately 62.5 percent of the metolachlor rate. AR 291 at 2. As a
result, Syngenta believed s-metolachlor would result in reduced environmental
loading. Id. However, because metolachlor was then the second most widely used
herbicide in the United States, Syngenta was not prepared to cancel its registration
immediately in favor of s-metolachlor. Id. at 3. Instead, Syngenta proposed a
three- to five-year phase-in period for s-metolachlor. Id.; AR 9. In order to achieve
this, Syngenta requested expedited review of s-metolachlor under the reduced risk
initiative. AR 291. While EPA was reviewing Syngenta’s application for smetolachlor, EPA’s Environmental Fate and Effects Division (EFED) issued
comments on s-metolachlor and determined it to be a reduced risk because of the
proposed reduction in exposure. AR 9. On March 14, 1997, EPA conditionally

4

registered s-metolachlor3 with an expiration date of February 14, 1998. AR 12; AR
211 att. EPA continued its review of data requirements and submissions for smetolachlor. See, e.g., AR 13 (summarizing EPA’s reviews and Syngenta’s
responses to those reviews).
After EPA registered s-metolachlor conditionally, Syngenta requested
voluntary cancellation of all metolachlor registrations on April 11, 1997. AR 113,
Vol. 1 at 27; see also 7 U.S.C. 136d(f)(1)(A) (explaining that a registrant may
request a voluntary cancellation of a pesticide registration). Syngenta requested
that the cancellation of technical metolachlor be effective July 1999, and the
cancellation of formulations containing metolachlor to be effective April 2000. AR
113, Vol. 1 at 27. According to Syngenta, EPA requested that Syngenta withdraw
its cancellation requests, which it did. Id. at 28.
In January 1998, Syngenta requested that EPA remove the expiration date
of s-metolachlor’s registration. AR 12.4 Syngenta recognized the registration
would remain conditional, however, due to outstanding data requirements. Id. EPA
and Syngenta had remained in communication concerning data requirements for s-

3

Not only was S-metolachlor Technical (CGA-77102) registered on March
14, 1997, but so, too, were products containing s-metolachlor. AR 12. These
include: Dual MAGNUM Herbicide, Bicep II MAGNUM Herbicide, Dual II MAGNUM
Herbicide, Bicep Lite II MAGNUM Herbicide, and Dual II MAGNUM SI Herbicide. Id.
4

Syngenta understood the expiration date associated with the registration of
s-metolachlor to be an oversight by EPA, because, on the same day, EPA
registered a pesticide with tolerances that were, themselves, time-limited. AR 12.
No such time-limited tolerances relate to s-metolachlor. Id.
5

metolachlor since its registration in March 1997. AR 13-23. In response to
Syngenta’s request, EPA “reassessed and found [s-metolachlor] acceptable for
conditional registration” without an expiration date. AR 15. As part of smetolachlor’s conditional registration without an expiration date, EPA did require
that Syngenta submit certain data, including (1) avian reproduction in bobwhite
quail study, (2) aquatic invertebrate life-cycle chronic toxicity study, (3) small-scale
prospective ground water monitoring study including terrestrial field dissipation,5
and (4) fathead minnow life-cycle and early life stage study.6 Id. EPA determined
the bobwhite quail study with metolachlor was not acceptable and could not be
bridged. AR 215. EPA found all chronic fish and invertebrate studies with
metolachlor to be invalid or supplemental. Id. Thus, they could not be bridged. Id.
Most of these studies had been part of the communications between EPA and
Syngenta since at least April 1997. See AR 13. In February 1998, EPA’s EFED
clarified in a memo to the Registration Division which data gaps had to be filled.

5

The terrestrial field dissipation study is also referred to as EPA Guideline
164-1. Sipcam Mem. Opp. 2, n. 5 [Dock. 348].
6

The fathead minnow study is also referred to as EPA Guideline 72-4(a) or
Early Life Stage Fish. Id. at 2, n. 4. However, MANA believes the fathead minnow
study is the 72-3D guideline study. MANA Mem. Supp. Mtn. Dismiss 10, n. 3
[Dock. 318]. The RED lists 72-4A (there is no 72-4(a)) as Early Life Stage Fish. AR
7 at 75. It lists 72-3D as Estuarine/Marine Toxicity Fish - TEP. Id. EPA required
Syngenta to submit a Fathead Minnow Life-Cycle and Early Life Stage Study listed
as 72-4(a). AR 15. EPA’s EFED also listed the fathead minnow life-cycle and early
life stage study as 72-4(a) in its data-gap clarification memo. AR 14. The record
supports the labeling of the fathead minnow study as guideline study 72-4(a) or
72-4A, not 72-3D.
6

AR 14. In listing those data requirements, EFED included additional requirements
not mentioned in its original April 1997 data review. Id. EPA and Syngenta
continued to debate data requirements for s-metolachlor at least through January
1999. AR 16-23.
Syngenta resubmitted its request for voluntary cancellation of metolachlor in
September 1999. AR 113, Vol. 1 at 28 (suggesting Syngenta sought cancellation
of technical and end-use metolachlor); AR 293 (requesting cancellation of
Metolachlor Technical). In December 1999, EPA published notice in the Federal
Register of the receipt of Syngenta’s request to cancel its metolachlor registrations.
AR 294; see also 7 U.S.C. § 136d(f)(1)(B), (C) (explaining that EPA must publish in
the Federal Register for 180 days notice of its receipt of a request for voluntary
cancellation of a pesticide registered for minor agricultural uses and the termination
of which would adversely affect its availability). In addition, Syngenta ceased
paying maintenance fees for its technical and end-use registrations. See AR 295
(informing Syngenta in February 2000 of EPA’s intent to cancel Syngenta’s
registrations due to failure to pay maintenance fees); AR 301 (informing Syngenta
in February 2001 of EPA’s intent to cancel Syngenta’s registrations due to failure
to pay maintenance fees).
Shortly after publication, in January 2000, then-Cedar Chemical Corporation
(“Cedar”) applied for a me-too registration of Metolachlor Technical dependent
upon Syngenta’s metolachlor registrations. See AR 29; see also 7 U.S.C. §
7

136a(c)(7)(A) (describing conditional registration of a pesticide or proposed use
that is identical or substantially similar to any currently registered pesticide or use
thereof and which would not significantly increase the risk of any unreasonably
adverse effect on the environment). In response, in March 2000, Syngenta
petitioned EPA to deny Cedar’s application. AR 25. However, neither Cedar nor
Syngenta provided EPA with sufficient information to determine the relative risk of
s-metolachlor compared with Metolachlor Technical. AR 52. As a result, EPA
requested that both parties submit further data to assist EPA in its determination.
Id.
During the period for public comment regarding Syngenta’s voluntary
cancellation, in June 2000, Cedar submitted objections to the cancellation of
Syngenta’s products, in part due to Cedar’s pending me-too application for
Metolachlor Technical. AR 297. Although the public comment period ended in
June 2000, EPA did not issue a cancellation order immediately thereafter.
Sipcam applied in October 2000 for a me-too Metolachlor Technical
conditional registration dependent, like Cedar’s application, on Syngenta’s
metolachlor registrations. AR 217.7 Just as it had for Cedar’s application,
Syngenta filed in November 2000 a petition to deny Sipcam’s application. AR 222.
In April 2001, Cedar ultimately submitted a revised application for its me-too

7

AR 217 is a sealed document; however, Syngenta acquired the same
document through the Freedom of Information Act. See Dock. 322, Ex. 3. Thus,
the information contained therein is not sealed within this Opinion.
8

technical metolachlor registration and two applications for me-too end-use
registrations.8 AR 55-57. In response, Syngenta petitioned to deny Cedar’s revised
technical metolachlor application.9 AR 82.
EPA eventually cancelled Syngenta’s end-use metolachlor registrations in
July 2001. 66 Fed. Reg. 38675, 38682 (noting the cancellation of, among others,
Dual 8E Herbicide and Dual II Herbicide, for non-payment of maintenance fee).
However, EPA left in effect Syngenta’s Metolachlor Technical registration until EPA
had reviewed the me-too applications. AR 303; AR 304.
Drexel followed Cedar and Sipcam and applied in September 2001 for a metoo Metolachlor Technical registration. AR 263.10 Thereafter, in December 2001,
Syngenta petitioned EPA to deny Drexel’s application. AR 266, 269.
Despite Syngenta’s petitions to deny the me-too applications, EPA issued
Cedar’s me-too conditional Metolachlor Technical and end-use registrations March
2002. AR 208-210. In so doing, EPA’s Herbicide Branch drafted a memorandum
reviewing the unreasonable adverse effect standard and data requirements for the

8

Cedar’s me-too applications were for Technical Metolachlor II, INTER Plus II,
and INTER 8E II.
9

The Court is unable to find in the Administrative Record evidence that
Syngenta petitioned EPA to deny Cedar’s end-use applications.
10

The Administrative Record on file with the Court identifies AR 263 as
having been redacted from the record. However, Syngenta freely cites AR 263 as
Exhibit 4 to Docket 322. Therefore, information from AR 263 is not sealed within
this Opinion.
9

me-too registrations. AR 211. This document also “constitute[d]” EPA’s decision
concerning Syngenta’s petition to deny Cedar’s applications. Id. In April 2002,
EPA issued Sipcam’s and Drexel’s technical me-too registrations. AR 261; AR 289.
Just as it had in anticipation of registering Cedar’s me-too pesticides, EPA drafted
an explanation of its decision which cited the Herbicide Branch’s earlier
memorandum to Cedar. AR 262; AR 290.
EPA conditioned these registrations on the submission of six studies that
remained data gaps from the previously issued DCIs for metolachlor: (1) avian
reproduction in bobwhite quail 71-4(a), (2) aquatic invertebrate life-cycle 72-4(b),
(3) turf field dissipation 164-1, (4) foliar residue dissipation 132-1(a), (5) dermal
passive dosimetry exposure 133-3, and (6) small scale prospective ground water
monitoring 166-1. AR 208; AR 261; AR 289. Since the data submission deadlines
for the DCIs had passed, EPA extended the deadlines for Cedar, Sipcam, and
Drexel to submit the required data. AR 208; AR 261; AR 289.
Once EPA registered Cedar’s, Sipcam’s, and Drexel’s me-too pesticides, EPA
determined “the purpose of FIFRA § 6(f) procedures ha[d] been served,” and it was
“prepared to act on Syngenta’s request for voluntary cancellation.” AR 304.
However, EPA provided Syngenta the opportunity to withdraw its voluntary
cancellation request if it chose “to have continued access to the metolachlor
market.” Id. Syngenta did not withdraw its cancellation request, and EPA
cancelled Syngenta’s technical metolachlor registration in August 2002. Dock.
10

330, Ex. 3.
III. Threshold Issues
In its motion to dismiss for lack of subject matter jurisdiction, MANA
contends (1) the case is moot, (2) the Court lacks jurisdiction to address Count II
because Syngenta erroneously brought it under the Administrative Procedure Act
(APA), (3) Syngenta lacks standing to pursue any of the three counts in its
complaint, and (4) Syngenta’s unclean hands bar its receipt of equitable relief.
EPA also argues Syngenta lacks standing to pursue its claims. Upon review, it is
determined that the Court does not have sufficient information to determine that
the case is moot; the Court does have jurisdiction to hear Count II; Syngenta has
standing to pursue Count I, Count III, and portions of its claims in Count II; and the
Court will not exercise its discretion to apply the unclean hands doctrine.
A. Mootness
MANA argues that events transpiring after Syngenta filed its Second
Amended and Supplemental Complaint (SASC) [Dock. 265] render Syngenta’s
allegations moot. Because “[t]he doctrine of mootness constitutes a part of the
constitutional limits of federal court jurisdiction,” “‘an actual controversy must be
extant at all stages of review, not merely at the time the complaint is filed.’”
Brooks v. Vassar, 462 F.3d 341, 348 (4th Cir. 2006) (quoting Arizonans for
Official English v. Arizona, 520 U.S. 43, 67 (1997)). “[I]f a party can demonstrate
that the apparent absence of a live dispute is merely a temporary abeyance of a
harm that is ‘capable of repetition, yet evading review,’” the case is not moot. Id.
11

Here, as MANA correctly notes, Syngenta stated in its Memorandum in
Opposition to MANA’s Motion to Compel that
even had EPA cancelled Syngenta’s metolachlor registrations as it
should have done, the private defendants could have obtained
unconditional metolachlor applications under FIFRA § 3(c)(5),
notwithstanding the cancellations, if they had applied in the years
earlier or simply cited Syngenta’s metolachlor database, . . . and
undertaken a small handful of studies required to complete the
scientific database for metolachlor before submitting their
applications.
Syngenta’s Mem. Opp. MANA’s Mtn. Compel 14. The studies necessary to fill the
metolachlor data gaps included avian reproduction in bobwhite quail, life cycle
chronic toxicity in mysid shrimp, early life stage chronic toxicity in fathead
minnows, small scale prospective groundwater study including a terrestrial
field/foliar residue dissipation component, and a turf dissipation study. SASC ¶
128. The Metolachlor Registrants’ registrations were conditioned on the
submission of each of these studies except the fathead minnow study.11 AR 208210. However, in August 2002, Drexel and Sipcam notified EPA that they were
removing turf use from their technical metolachlor labels. Dock. 318, Ex. 11. After
publication of the use deletions and time for public comment, EPA was to delete

11

MANA explains that EPA did not require the fathead minnow study
because EPA determined as part of the RED that the study was not applicable.
MANA cites guideline study 72-3D in the RED as being “N/A,” see AR 7 at 75;
however, as explained supra in footnote 6, the fathead minnow study is guideline
study 72-4(a) or 72-4A. The RED provides a citation for the 72-4A study,
indicating no data gap for metolachlor. AR 7 at 75. This is the more likely
explanation for its not appearing on the Metolachlor Registrants’ conditional
registration requirements.
12

officially turf use from their labels. Id. Then, the turf field dissipation and foliar
residue dissipation studies would no longer be required. Id. In July 2005, MANA12
sought a similar cancellation of turf uses from its technical metolachlor registration.
Id. As a result, of the studies initially required of the Metolachlor Registrants, only
the bobwhite quail, mysid shrimp, and groundwater study without the dissipation
component remain required studies. According to MANA, the Metolachlor
Registrants have submitted these studies to EPA and requested unconditional
registration under 7 U.S.C. 136a(c)(5). Dock. 318, Ex. 12. Although MANA
describes EPA’s pending action as “ministerial,” see MANA’s Mem. Supp. Mtn.
Dismiss 11, neither MANA, nor any other Metolachlor Registrant, has submitted
evidence to the Court that EPA has granted the Metolachlor Registrants
unconditional registrations. Thus, there is insufficient evidence to determine
Syngenta’s claims are moot.
MANA also argues Syngenta’s claims are moot because, even if Syngenta’s
studies were entitled to exclusive use protections at the time EPA granted the metoo registrations, they are no longer exclusive use studies. MANA correctly
calculates that, according to the record, Syngenta’s studies would presently not be
exclusive use studies. However, evidence in the record supports Syngenta’s
contention, for purposes of MANA’s mootness argument, that Syngenta’s studies
were entitled to exclusive use protection at the time EPA issued me-too

12

Cedar transferred its registrations to MANA in 2003.
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registrations to the Metolachlor Registrants. The expiration of such protection due
to the passage of time does not make Syngenta’s claims of exclusive use right
violations moot.
B. Jurisdiction to Hear Count II
The APA “provides a framework for judicial review of final agency action
when an adequate remedy is otherwise lacking.” Defenders of Wildlife v. Admin.,
E.P.A., 882 F.2d 1294, 1303 (8th Cir. 1989) (analyzing the relationship between
the APA and FIFRA) (citing 5 U.S.C. § 704). This is not such a case. Instead,
“FIFRA provides for judicial review of the EPA’s pesticide registration decisions.”
Dow AgroSciences LLC v. Nat’l Marine Fisheries Serv., 637 F.3d 259, 262 (4th
Cir. 2011) (citing 7 U.S.C. § 136n). While FIFRA provides for judicial review, the
APA provides the scope of such review. Defenders of Wildlife, 882 F.2d at 1303
(citing 5 U.S.C. § 706).
Syngenta entitled Count II “Arbitrary and Capricious Agency Action in
Violation of the APA.” Although this title is inartful in its suggestion that a
violation of the APA is sufficient for judicial review in this case, Syngenta asserts
that it “is not attempting to make a collateral attack on EPA’s actions under FIFRA
by invoking the APA.” Syngenta Mem. Opp. MANA’s Mtn. Dismiss 15 [Dock.
358]. Syngenta not only acknowledges that FIFRA provides for judicial review of
agency action under the statute, but it contends its claims in Count II are violations
of FIFRA reviewable under the APA standard of review. Id. at 14-15. In reviewing
14

Count II and Syngenta’s understanding of the law, it is determined that Syngenta’s
allegations in Count II are brought as violations of FIFRA, not the APA. Therefore,
the Court does have jurisdiction to hear Count II.
C. Standing
“The standing doctrine is an indispensable expression of the Constitution’s
limitation on Article III courts’ power to adjudicate ‘cases and controversies.’”
Frank Krasner Enters., Ltd. v. Montgomery County, MD, 401 F.3d 230, 234 (4th
Cir. 2005) (quoting Allen v. Wright, 468 U.S. 737, 750-51 (1984)). The standing
analysis involves “constitutional limitations on federal-court jurisdiction and
prudential limitations on its exercise.” Warth v. Seldin, 422 U.S. 490, 498 (1975).
“‘[T]he question of standing is whether the litigant is entitled to have the court
decide the merits of the dispute or of particular issues,’ which is always a distinct
inquiry from the question of how a litigant’s claim should be decided.” Long Term
Care Partners, LLC v. United States, 516 F.3d 225, 241 (4th Cir. 2008) (quoting
Warth, 422 U.S. at 498). Standing “does not depend upon [a plaintiff’s] ultimate
success on the merits underlying his case.” Covenant Media of SC, LLC v. City of
North Charleston, 493 F.3d 421, 429 (4th Cir. 1007) (citing Warth, 422 U.S. at
500).
It is the burden of the plaintiff to support each element of standing “in the
same way as any other matter on which the plaintiff bears the burden of proof,
i.e., with the manner and degree of evidence required at the successive stages of
15

the litigation.” Lujan v. Defenders of Wildlife, 504 U.S. 555, 561 (1992).
Therefore, in response to a motion for summary judgment, the plaintiff must cite to
particular parts of materials in the record. Lujan, 504 U.S. at 561 (citing earlier
version of Fed. R. Civ. P. 56(e)). Furthermore, the plaintiff must establish standing
for each claim it asserts. DaimlerChrysler Corp. v. Cuno, 547 U.S. 332, 352
(2006) (citing Allen, 468 U.S. at 752).
The “irreducible constitutional minimum of standing” requires (1) that the
plaintiff have suffered an injury in fact, (2) that there be a causal connection
between the injury and the conduct challenged, and (3) that a favorable decision
will redress the injury. Lujan, 504 U.S. at 560-61. The plaintiff’s injury in fact
must be an invasion of a legally protected interest which is concrete, particularized,
and actual or imminent. Id. at 560. The causal connection demands the plaintiff’s
injury be “‘fairly ... trace[able] to the challenged action of the defendant, and not
... th[e] result [of] the independent action of some third party not before the
court.’” Id. (quoting Simon v. E. Ky. Welfare Rts. Org., 426 U.S. 26, 41, 42
(1976)). Finally, it must be “likely,” not merely speculative, that a favorable ruling
will redress plaintiff’s injury. Id. (quoting Simon, 426 U.S. at 38, 43). If the
plaintiff is an object of the challenged action or inaction, “there is ordinarily little
question that the action or inaction has caused him injury, and that a judgment
preventing or requiring the action will redress it.” Id. at 561-62. On the other
hand, standing becomes “substantially more difficult” to prove when the plaintiff’s
16

injury results from unlawful government regulation of someone else. Id. at 562.
Prudential standing often involves matters of judicial self-governance that
protect courts from having to “decide abstract questions of wide public
significance even though other governmental institutions may be more competent
to address the questions and even though judicial intervention may be unnecessary
to protect individual rights.” Warth, 422 U.S. at 500. Prudential considerations
include “the requirement that a plaintiff’s complaint fall within the zone of interests
protected by the law invoked” and the general prohibitions on a plaintiff raising a
third party’s rights and the adjudication of general grievances. Allen, 468 U.S. at
751; see also Ass’n of Data Processing Serv. Orgs., Inc. v. Camp, 397 U.S. 150,
153 (1970) (“[T]he question [is] whether the interest sought to be protected by the
complainant is arguably within the zone of interests to be protected or regulated by
the statute or constitutional guarantee in question.”). In determining whether the
plaintiff’s interests fall within those arguably to be protected, the “inquiry must be
determined not by reference to the overall purpose of the statute in question but,
instead, by reference to the particular provision(s) of law upon which the plaintiff
seeks redress.” Taubman Realty Grp. Ltd. P’ship v. Mineta, 320 F.3d 475, 480
(4th Cir. 2003) (internal citations omitted).
In order for a plaintiff’s interests to be within the zone of interests regulated
by the statute in question, the plaintiff must be directly regulated by the agency
action it challenges. Calumet Indus., Inc. v. Brock, 807 F.2d 225, 228-29 (D.C.
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Cir. 1986). “It is not enough that [a plaintiff] be regulated merely by the statute
upon which the agency action is based.” Id.; cf. Taubman Realty Grp. Ltd. P’ship,
320 F.3d at 480 (stating the relevant focus is on the particular provision of the law
upon which the plaintiff seeks redress).
In order for a plaintiff that is not the subject of the contested regulatory
action to have prudential standing, its interests cannot be “so marginally related to
or inconsistent with the purposes implicit in the statute.” TAP Pharm. v. U.S. Dep’t
of Health & Hum. Servs., 163 F.3d 199, 203 (4th Cir. 1998) (quoting Clarke v.
Sec. Indus. Ass’n, 479 U.S. 388, 399 (1987)). Therefore, to determine whether
plaintiff’s interests are within the zone of interests to be protected, the court must
“first discern the interests ‘arguably . . . to be protected’ by the statutory provision
at issue” and “then inquire whether the plaintiff’s interests affected by the agency
action in question are among them.” Id. (quoting Nat’l Credit Union Admin. v. First
Nat’l Bank & Trust Co., 522 U.S. 479, 492 (1998)). The statute’s language and
legislative history are relevant to determining what interests the statutory provision
arguably protects. Blackhawk Indus. Prods. Grp. Unltd., LLC v. U.S. Gen. Servs.
Admin., 348 F.Supp.2d 662, 671 (E.D.Va. 2004) (citing Air Courier Conf. of Am.
v. Am. Postal Workers Union AFL-CIO, 498 U.S. 517 (1991)). When a plaintiff
asserts its commercial interests, those interests are within the zone of interest only
if those interests “put [the plaintiff] in the same position as a member of the [group
subject to the statutory provision] or a commercial competitor of such a member.”
18

TAP Pharm., 163 F.3d at 208. The Fourth Circuit has recognized that
[t]he Supreme Court rulings providing commercial competitors with
standing reflect the principle that when Congress passes a statute
regulating a defined class, its intention to limit the class must be given
the same respect as its intention to regulate it. . . . Where . . .
commercial interests are concerned, this legislative restraint can be
presumed to indicate a Congressional intention to protect the interests
of the competitors of the parties regulated from encroachment beyond
that caused by the statute’s terms. Such a presumption can safely be
made because, in the commercial sphere, benefit or detriment to one
party can be fairly assumed to have the opposite effect on the
interests of the party’s competitors.
Id. at 207-08.
1. Count I
In Count I of the SASC, Syngenta asserts a violation of the exclusive use
protection provisions in FIFRA. Specifically, Syngenta alleges that it has a
proprietary right to the ten-year exclusive use of studies that it submitted in 1998
to EPA in support of its application to register s-metolachlor. SASC ¶ 175.
Syngenta alleges that, in issuing metolachlor registrations to the Metolachlor
Registrants, EPA relied on Syngenta’s chronic toxicity study on fathead minnows
and terrestrial field dissipation study. Id. at ¶ 177. Syngenta further alleges that
EPA failed to provide Syngenta, the original data submitter, with the requisite thirty
days notice and opportunity to obtain information on the Metolachlor Registrants’
applications. Id. at ¶¶ 178-80. Not only has Syngenta alleged injury in fact in its
complaint, but it has, as it must at this stage, supported its allegations with facts

19

in the Administrative Record.13
As part of its registration of s-metolachlor, Syngenta submitted studies,
including: (1) avian reproduction in bobwhite quail, (2) aquatic invertebrate lifecycle chronic toxicity, (3) early life stage chronic toxicity in fathead minnows, and
(4) small scale prospective ground water monitoring, including a terrestrial field
dissipation study. AR 15. Ten-year exclusive use protection is afforded to studies
that (1) pertain to a new active ingredient/chemical first registered after September
30, 1978, (2) were submitted in support of or as a condition of the application
resulting in the first application of a product with the new active
ingredient/chemical or an application to amend such registration to add a new use,
and (3) were not submitted to satisfy FIFRA § 3(c)(2)(B), which requires data to
maintain a registration. 40 C.F.R. § 152.83.
Syngenta contends its studies submitted in support of s-metolachlor’s
registration meet the requirements as exclusive use studies. Syngenta applied to
register s-metolachlor under the reduced risk initiative’s expedited review process.
AR 291. As part of its application, Syngenta used bridging data from
metolachlor’s registration. Id. EPA conditionally registered s-metolachlor on March
14, 1997 with an expiration date of February 14, 1998. AR 211, att.; AR 15.
During its continued review of data requirements and submissions for s-

13

At this stage in the Opinion, Syngenta’s allegations and facts in the AR are
used solely to determine the issue of standing. The merits of Syngenta’s claims
are addressed later in the Opinion.
20

metolachlor, EPA determined Syngenta needed to submit additional studies
particular to s-metolachlor. AR 14-23. Syngenta agreed to submit certain studies,
but contested the necessity of others. See, e.g., AR 13.
In January 1998, Syngenta requested removal of the expiration date to
which EPA agreed as long as Syngenta submitted various studies. AR 15. These
studies had been part of the discussion between EPA and Syngenta since smetolachlor’s conditional registration. AR 13 (summarizing EPA’s reviews and
Syngenta’s responses). EPA acknowledged that it had “reassessed” s-metolachlor
and “found [it] acceptable for conditional registration” as long as the listed studies
were submitted by particular dates. AR 15. Subsequently, Syngenta submitted
requested studies. See, e.g., AR 23.
According to Syngenta, not only were its studies entitled to exclusive use
protection, but EPA allegedly violated Syngenta’s exclusive use protection.
Syngenta argues EPA did so by permitting the Metolachlor Registrants to use
Syngenta’s fathead minnow and terrestrial field dissipation studies to support their
me-too metolachlor registrations. In assessing data requirements for s-metolachlor,
EPA determined the existing fathead minnow study for metolachlor to be
supplemental. AR 14. In addition, EPA listed the terrestrial field dissipation study
as part of the 164-1 dissipation studies that remained data gaps from EPA’s review
of s-metolachlor in April 1997. AR 15. Therefore, EPA required Syngenta to
submit these studies as part of s-metolachlor’s registration. AR 15. However, EPA
21

did not require the Metolachlor Registrants to submit those studies in support of
their me-too registrations. AR 208; AR 261; AR 289. Syngenta reasons that if it
had to submit the studies according to EPA’s explanations, so, too, should the
Metolachlor Registrants. Since EPA did not require the Metolachlor Registrants to
submit either study, Syngenta concludes EPA must have relied on Syngenta’s
fathead minnow study and terrestrial field dissipation study to support the me-too
registrations. If EPA did so, as Syngenta alleges, EPA violated Syngenta’s
exclusive use rights to those studies.
Syngenta also alleges EPA failed to provide it thirty days notice before
registering “a product containing an active ingredient for which a previously
submitted study is eligible for exclusive use.” 40 C.F.R. § 152.116(a). If the
exclusive use data submitter requests within thirty days of the notice, EPA must
provide the applicant’s data requirements and method of demonstrating compliance
with the requirements. Id. According to Syngenta, EPA failed to do so. See AR 25
at 30; AR 82 at 45.
Without determining Syngenta’s claim on its merits, the Court finds
Syngenta has supported its allegations of injury in fact with evidence from the
record14 that describe an injury in fact. The same facts from the record also
suggest the injury is fairly traceable to the actions of EPA.
Finally, a favorable decision by this Court would redress the injury. Among

14

See supra pp. 20-22.
22

the relief Syngenta seeks are its requests that the Court order the Metolachlor
Registrants’ me-too registrations cancelled and, at the request of the Metolachlor
Registrants, remand to EPA to allow it to evaluate properly the me-too registrations
as the Metolachlor Registrants may revise them. SASC at 47, ¶ 13. Further,
Syngenta requests this Court to enjoin the Metolachlor Registrants from
manufacturing, distributing, or selling metolachlor, using any metolachlor
registration, or transferring any metolachlor registration. Id. at ¶ 14. If the Court
were to grant Syngenta any of these requests for relief, the Metolachlor
Registrants would effectively be unable to continue to benefit from the me-too
registrations at issue in this case that EPA allegedly registered using Syngenta’s
exclusive use studies. Although Syngenta’s studies submitted for s-metolachlor in
1998 would likely not be exclusive use studies presently,15 they would have been
exclusive use studies, if at all, at the time the me-too registrations were issued.
Thus, if the me-too registrations were issued using Syngenta’s exclusive use
studies, not only were they unlawfully issued, but any subsequent registrations
based on the me-too registrations at issue would likely also be unlawful.
Cancelling those registrations and, at the request of the Metolachlor Registrants,
remanding to EPA and permitting the Metolachlor Registrants to revise their

15

Exclusive use studies are protected for ten years. 7 U.S.C. §
136a(c)(1)(F)(I). However, in certain instances, the period of exclusive use can be
extended. 7 U.S.C. § 136a(c)(1)(F)(ii). It is unclear whether Syngenta’s studies
would have received an extended period of protection.
23

metolachlor applications would protect Syngenta from any further injury.
Not only has Syngenta established constitutional standing regarding Count
1, but it also has prudential standing to bring the claim. Exclusive use protection is
“primarily concerned with protecting the economic interests of data submitters.”
49 Fed. Reg. 30884, 30888. Its purpose it to “encourage continued research and
development of new, more effective, and safer pesticides by giving producers —
who often devote many years and millions of dollars to developing a new pesticide
— a period of protection against competition.” Id. If Syngenta’s studies submitted
for s-metolachlor are exclusive use studies, Syngenta is certainly within the zone of
interests of 7 U.S.C. 136a(c)(1)(F) and 40 C.F.R. § 152.83. Syngenta has,
therefore, cited to evidence in the Administrative Record that supports the
determination that Syngenta is in the proper position so as to make the argument
that its exclusive use rights were violated and to pursue such a claim.
2. Count II
Syngenta’s standing to pursue Count I does not confer standing for the
remaining counts. Syngenta must establish standing for each claim it asserts. In
Count II of the SASC, Syngenta broadly alleges arbitrary and capricious agency
action in violation of the APA. However, the allegations in Count II are varied and,
at times, redundant. Thus, the Court analyzes each paragraph of Count II that
asserts a claim to determine whether Syngenta has standing to pursue that
particular claim. After doing so, it is determined that Syngenta has standing to
24

challenge the actions asserted in paragraph 188. While Syngenta meets the
standing requirements for the allegation in paragraphs 184, the assertion is
duplicative of those made in paragraphs 178 and 179 of Count I. Likewise,
although Syngenta has standing to pursue the allegations in paragraphs 189 and
193 that relate to EPA’s registering the Metolachlor Registrants’ pesticides under 7
U.S.C. § 136a(c)(7)(A) when Syngenta had requested that EPA cancel its
registrations, these assertions reiterate the allegation in paragraph 188 of Count II.
In paragraph 184, Syngenta alleges “EPA’s failure, in violation of FIFRA and
its implementing regulations, to provide Syngenta with thirty days notice prior to
issuing the metolachlor registrations, and the opportunity to obtain additional
information regarding any support that exists for the registrations, is arbitrary and
capricious.” This allegation mirrors those in paragraph 178, 179, and 180 of
Count I. See supra p. 22. As such, although Syngenta meets the standing
requirements to pursue the allegation in paragraph 184, see supra pp. 20-24, the
paragraph is duplicative of Syngenta’s contentions in Count I.
Syngenta’s allegations in paragraphs 185, 186, and 187 are not stand alone
claims, nor may they be integrated in Syngenta’s allegations in Count 1 because
Syngenta lacks standing to assert them. In paragraphs 185, 186, and 187,
Syngenta presents very similar, if not the same, allegations. In paragraph 185,
Syngenta asserts that EPA’s refusal to provide a reasoned basis for its decision to
deny Syngenta’s petitions to deny was arbitrary and capricious. Similarly, in
25

paragraph 186, Syngenta contends EPA’s March 21, 2002 memorandum did not
explain EPA’s decision to grant the Metolachlor Registrants’ registrations and failed
to address the issues Syngenta raised in its petitions to deny. Consequently,
according to Syngenta, these actions were also arbitrary and capricious. In
paragraph 187, Syngenta merely reiterates its argument that EPA de facto denied
Syngenta’s petitions to deny and states the standard of review of such actions
under the APA. All three paragraphs assert the same claim — EPA’s failure to
provide a reasoned explanation for its denial of Syngenta’s petitions to deny and
grant of the Metolachlor Registrants’ registrations was arbitrary and capricious. If,
as Syngenta contends, its studies submitted in support of s-metolachlor are
exclusive use studies, then Syngenta would have been able to “petition [EPA] to
deny . . . the registration of a product . . . [since Syngenta] has submitted to [EPA]
a valid study which, [Syngenta] claims, satisfies a data requirement that an
applicant purportedly has failed to satisfy.” 40 C.F.R. § 152.99. Under the
impression that it held exclusive use rights to the studies in question, Syngenta
petitioned EPA to deny the Metolachlor Registrants’ registrations. AR 25; AR 222;
AR 82; AR 266; AR 269. Although Syngenta alleges EPA’s response to the
petitions was arbitrary and capricious, Syngenta alleges no injury in fact. If its
exclusive use rights allegations are correct and it, therefore, had the right to
petition EPA to deny a registration pursuant to 40 C.F.R. § 152.99, Syngenta was
not prevented from doing so. Consequently, Syngenta does not have standing to
26

pursue its allegations in paragraphs 185, 186, and 187.
In paragraph 188, Syngenta contends EPA’s refusal to cancel Syngenta’s
technical metolachlor registration until EPA had evaluated the Metolachlor
Registrants’ applications was arbitrary and capricious, not in accordance with the
law, and, thereby, singled out Syngenta for treatment that differed from all other
similarly-situated parties. As 7 U.S.C. § 136d(f)(1)(A) permits, in September
1999, Syngenta submitted its request for voluntary cancellation of metolachlor,
including technical metolachlor. AR 293. As required, EPA published notice of
Syngenta’s cancellation request in the Federal Register in December 1999. AR
294. Syngenta also ceased paying maintenance fees for its technical metolachlor.
AR 295; AR 301. However, EPA did not cancel Syngenta’s technical metolachlor
until August 2002. Dock. 330, Ex. 3.
After Syngenta sought voluntary cancellation and EPA published notice of
the request, Cedar, Sipcam, and Drexel applied for me-too registrations dependent
on Syngenta’s metolachlor registrations. AR 29; AR 217; AR 263. As a result,
EPA delayed cancelling Syngenta’s technical metolachlor while EPA reviewed
applications for technical me-too registrations. AR 303; AR 304. EPA would not
have been able to grant the me-too registrations without a substantially similar or
identical pesticide currently registered. 7 U.S.C. § 136a(c)(7)(A). Prior to its
cancellation of Syngenta’s technical metolachlor registration, EPA issued me-too
registrations to Cedar, Sipcam, and Drexel. AR 208; AR 261; AR 289. By
27

delaying the cancellation of Syngenta’s technical metolachlor registration, EPA
permitted Cedar, Sipcam, and Drexel to obtain me-too registrations based on
Syngenta’s technical metolachlor registration.
Cedar, Sipcam, and Drexel obtained registration under 7 U.S.C. §
136a(c)(7)(A). However, had Syngenta’s technical metolachlor been cancelled
after EPA complied with the procedures set forth in 7 U.S.C. § 136d(f)(1)(A)-(C) by
providing notice and time for public comment, Cedar, Sipcam, and Drexel would
likely have had to register under the 7 U.S.C. § 136a(c)(7)(C) or 7 U.S.C. §
136a(c)(5) more stringent registration provisions. Instead, Syngenta’s metolachlor
registrations were used by EPA to provide a me-too basis for Cedar’s, Sipcam’s,
and Drexel’s registrations despite Syngenta’s request to cancel its registrations.
As a result, Cedar, Sipcam, and Drexel became competitors of Syngenta in the
technical metolachlor market. If EPA’s actions were improper, not only did
Syngenta suffer a competitive or commercial injury, but EPA’s actions clearly
caused the injury which a favorable court decision would redress. Among
Syngenta’s requests for relief is the request that the me-too registrations be
cancelled and, if the Metolachlor Registrants choose, revised and reassessed by
EPA. As a result, Cedar, Sipcam, and Drexel would likely have to submit
applications no longer based on Syngenta’s now-cancelled registrations.
Not only does Syngenta meet the constitutional requirements for standing to
pursue the claim in paragraph 188, but Syngenta also meets the prudential
28

requirements. Syngenta is directly regulated by the agency action - or delayed
action - it challenges. Syngenta sought voluntary cancellation pursuant to 7 U.S.C.
§ 136d(f)(1), and EPA delayed such cancellation in order to review and register metoo applications submitted after public notice of Syngenta’s cancellation request.
As the subject of the contested regulatory action, Syngenta is within the zone of
interests regulated by the statutory provision in question. Thus, Syngenta has
cited to evidence in the Administrative Record that supports the determination that
Syngenta is in the proper position to make the argument that EPA’s delay in
cancelling Syngenta’s metolachlor registrations was arbitrary and capricious and to
pursue such a claim.
Although Syngenta does have standing to challenge EPA’s actions alleged in
paragraph 188 as arbitrary and capricious, Syngenta’s assertion that EPA’s actions
“singled out Syngenta for treatment that differed from all other similarly-situated
parties” is an equal protection claim, not a claim of arbitrary and capricious agency
action.
Paragraphs 189 and 193 seem to allege the same violation and are treated
as asserting the same claim for purposes of the standing analysis. Paragraph 189
alleges “EPA acted arbitrarily and capriciously, in violation of FIFRA, in granting
metolachlor registrations . . . under FIFRA § 3(c)(7)(A) rather than FIFRA §
3(c)(7)(C).” Similarly, in paragraph 193, Syngenta contends “EPA acted arbitrarily
and capriciously . . . in evaluating the Metolachlor Registrants’ applications under
29

FIFRA § 3(c)(7)(A), because the products proposed for registrations were not
identical or substantially similar in composition and proposed use to any pesticide
product then currently registered.” It is unclear both from the SASC and
Syngenta’s briefs on what basis it is challenging EPA’s actions. Syngenta seems
to be arguing either (1) EPA relied on Syngenta’s registrations for which it was
seeking voluntary cancellation when EPA analyzed and registered the me-too
pesticides or (2) EPA registered Cedar’s two end-use me-too pesticides after EPA
had cancelled Syngenta’s end-use registration or (3) both. Compare Syngenta Mtn.
S.J. 3, ¶ 9 [Dock. 319] (stating that because Syngenta’s technical registration was
effectively cancelled, EPA was required to analyze and register the Metolachlor
Registrants’ applications under FIFRA § 3(c)(5) or FIFRA § 3(c)(7)(C)), with
Syngenta Mem. Supp. Mtn. S.J. 7 [Dock. 320] (stating EPA violated FIFRA by
issuing Cedar’s two end-use registrations after EPA cancelled Syngenta’s end-use
registration), and Syngenta Mem. Opp. Sipcam’s Mtn. S.J. 4-8 [Dock. 346]
(distinguishing technical and end-use metolachlor and arguing applications for enduse metolachlor must be compared to existing end-use, not technical, metolachlor).
This Court found in its March 31, 2006 Memorandum Opinion that EPA’s
determination of the substantial similarity of the Metolachlor Registrants’ pesticides
to Syngenta’s pesticides was committed to the Agency’s discretion and, thus, not
reviewable. Syngenta Crop Prot., Inc. v. U.S. EPA, 439 F.Supp.2d 458, 463
(M.D.N.C. 2006). In its Memorandum in Opposition to Sipcam’s Motion for
30

Summary Judgment, Syngenta essentially argues technical metolachlor is not
substantially similar to end-use metolachlor, and, consequently, EPA improperly
found the two to be substantially similar when it registered the me-too end-use
pesticides. Syngenta Mem. Opp. Sipcam’s Mtn. S.J. 4-8. These allegations are
not reviewable.
However, in so far as Syngenta alleges in paragraphs 189 and 193 that
EPA’s actions are arbitrary and capricious because it registered the me-too
pesticides under 7 U.S.C. § 136a(c)(7)(A) when Syngenta had previously
requested cancellation of its registrations, Syngenta’s allegations parallel those
made in paragraph 188. Although Syngenta has standing to pursue its allegations
in paragraphs 189 and 193 that relate to Syngenta’s request for voluntary
cancellation and EPA’s delay in cancellation in order to analyze and register me-too
pesticides, see supra pp. 27-29, these allegations are duplicative of those in
paragraph 188 of Count II.
The allegations in paragraph 190 center around EPA’s permitting the
Metolachlor Registrants to submit required data “years after the deadlines imposed
upon Syngenta for its registration of similar pesticides had passed.” There is no
support in the record that Syngenta suffered an injury in fact from EPA’s permitting
the Metolachlor Registrants to submit studies that remained data gaps for
metolachlor years after the original deadline for then-metolachlor-registrants to
submit the data. None of Syngenta’s rights were violated by such action.
31

Furthermore, Syngenta has no prudential standing to pursue this claim. Syngenta
is not regulated by EPA’s permitting the Metolachlor Registrants to submit data
under new deadlines. Nor are Syngenta’s interests — competitive interests if there
were such an injury in fact — protected by the statutory provision at issue. 7
U.S.C. § 136a(c)(7)(A) permits EPA to register a pesticide even if an applicant is
unable to submit certain data, as long as EPA “will require the submission of such
data not later than the time such data are required to be submitted with respect to
similar pesticides already registered.” Congress enacted legislation in 1978
authorizing EPA to issue conditional registrations, something EPA had never before
had the authority to do. 47 Fed. Reg. 57624, 57625 (Dec. 27, 1982). Prior to the
1978 amendment to FIFRA, EPA believed it was required to deny registrations of
new products, even if they contained old ingredients, until all testing of the
pesticide was complete and results reviewed. Id. EPA, Congress, and the pesticide
industry were concerned about the difficulty this posed for applicants seeking to
enter the market with products essentially the same as already-registered products.
Id. Therefore, conditional registration serves to “eliminate barriers to registration
and market entry” and “provide a needed transition phase between the case-bycase approach [of the past] and the new registration standards process.” Id.
Syngenta’s commercial interests as the registrant of an already-registered pesticide
are not protected by EPA’s discretionary authority to grant conditional registrations
and set deadlines for data submission. As a result, Syngenta does not have
32

standing to pursue it claim in paragraph 190.
Nor does Syngenta have standing to pursue its claims in paragraphs 191 and
192. In paragraph 191, Syngenta alleges EPA acted arbitrarily and capriciously in
determining that the me-too registrations would not significantly increase the risk
of unreasonable adverse effects on the environment. In paragraph 192, Syngenta
asserts that EPA failed to conduct an incremental risk assessment. EPA has
discretion to conditionally register pesticides if EPA determines doing so “would
not significantly increase the risk of any unreasonable adverse effect on the
environment.” 7 U.S.C. § 136a(c)(7(A). “[C]entral” to conditional registration is
the incremental risk assessment. 47 Fed. Reg. 57624, 57626. However, the
record does not support an injury in fact — a concrete, particularized, and actual
injury — to Syngenta. Instead, the only injury is likely a perceived harm to the
environment due to “unnecessary additional loading on the environment of millions
of pounds of pesticide each year.” SASC p. 49, ¶ 164. This “generally available
grievance about government — claiming only harm to [Syngenta’s] and every
citizen’s interest in proper application of the . . . laws . . . does not state an Article
III case or controversy.” Lujan, 504 U.S. at 573-74.
In sum, of the allegations in Count II, Syngenta has standing to pursue as a
stand-alone claim that in paragraph 188.
3. Count III
In Count III of SASC, Syngenta alleges EPA’s actions violate the Equal
33

Protection Clause of the Fifth Amendment of the United States Constitution.
Despite this claim, Syngenta is unable to show injury from EPA’s alleged actions.
An injury in fact suffered from an equal protection violation is the “inability to
compete ‘on an equal footing.’” Farmer v. Ramsay, No. 01-2039, 2002 WL
1766615 *1, *5 (4th Cir. 2002) (quoting N.E. Fla. Chapter, Associated Gen.
Contractors of Am. v. City of Jacksonville, 508 U.S. 656, 666 (1993)) (both cases
involving race-based equal protection violation allegations).
In the February 2008 hearing before Magistrate Judge Eliason involving the
compelling of discovery, Judge Eliason inquired of Syngenta in the context of its
equal protection claim, “[I]s your claim that you’re injured because your
competitors gained an advantage and that’s where your injury is?” Hr’g Tr. 18:2023 [Dock. 304]. Syngenta’s response was “We’re not alleging an injury to
Syngenta, we’re challenging the legality of EPA’s decision to grant registrations
improperly to our competitors.” Id. at 18:24-19:2. Judge Eliason attempted to
clarify Syngenta’s equal protection claim and associated injury when he said,
[I]f I thought that part of your equal protection claim was going to
start saying that, and this benefited [sic] our competitors and that’s
where the injury is, then, I’m going to grant the motion to compel
because you’re bringing competition in as a factor for the court to
weigh in determining whether EPA somehow applied the incorrect
standard.
Id. at 19:3-11. Syngenta responded, “That is really not where we have gone.” Id.
at 19:19-18. Again Judge Eliason responded,
If you’re going to tell the Court, and by the way, we were treated
34

differently and we have suffered a competitive injury, that is, our
competitors profited from this, and, therefore, that’s why we wanted
you to allow us to pursue the equal protection claim, . . . then, I think
that the request with respect to your motives in wanting to cancel
may well come into play. But if we’re not going to get into that, and
it may well cut out your equal protection claim entirely because you
don’t have any injury.
Id. at 19:15-20:2. Syngenta replied, “We’re not seeking any relief for injury to
Syngenta. . . . We do think that the biggest benefit from pursuing this lawsuit is to
ensure that there is consistency, certainty and transparency in how EPA applied
the standards that Congress laid out in the statute.” Id. at 20:28-19.
Not only did Syngenta disavow injury in the hearing before Judge Eliason as
it relates to its equal protection claim, but since that time Syngenta has not
proffered evidence of any such injury. Instead, Syngenta asserts injury for all of its
claims solely on the alleged exclusive use rights violation. See, e.g., Syngenta’s
Opp. MANA’s Mtn. Dismiss 6. However, if a a violation of its exclusive use rights
occurred, such injury is insufficient to support Syngenta’s equal protection violation
claim. In pursuing its equal protection claim, Syngenta has focused on EPA’s
refusal to cancel Syngenta’s technical metolachlor registration while me-too
applications were pending, not on EPA’s alleged violation of Syngenta’s exclusive
use rights. Consequently, it is determined that, having suffered no injury related to
its equal protection claim, Syngenta does not have standing to pursue Count III.

35

D. Unclean Hands
1. Applicability of the Doctrine
The doctrine of unclean hands “closes the door of a court of equity to one
tainted with inequitableness or bad faith relative to the matter in which he seeks
relief, however improper may have been the behavior of the defendant.” Precision
Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806, 814 (1945). The
“misconduct need not necessarily have been of such a nature as to be punishable
as a crime or as to justify legal proceedings of any character.” Id. at 815. Instead,
“[a]ny willful act concerning the cause of action which rightfully can be said to
transgress equitable standards of conduct is sufficient cause for the invocation of
the maxim.” Id. Further, if a party’s hands are unclean, a court has discretion in
applying the doctrine. Id. at 814. Thus, a court may bar all recovery for the party
or a court may bar recovery for only the claims tainted by the unclean hands.
Smith v. Cessna Aircraft Co., 124 F.R.D. 103, 107 (D.Md. 1989) (citing
Pennsylvania, Illinois, New Jersey cases for this proposition).
MANA claims the doctrine of unclean hands bars any equitable relief this
Court could grant Syngenta. However, neither the internal memoranda nor any
other of Syngenta’s actions supports the application of the doctrine of unclean
hands. Instead, the documents MANA cites reflect appropriate business decisions
discussed by Syngenta, a participant in a competitive market. Therefore, it is
determined that the doctrine of unclean hands is inapplicable.
36

2. MANA’s Motion to Unseal
After filing its Motion to Dismiss for Lack of Subject Matter Jurisdiction and
Memorandum in Support, MANA filed a motion to unseal those documents, along
with accompanying exhibits. MANA filed its motion to dismiss and memorandum
in support of its motion under seal because, not only did it attach as exhibits two
confidential internal memoranda of Syngenta, but it referred specifically to those
documents in its memorandum. The two internal Syngenta memoranda were
submitted to MANA during discovery limited to MANA’s unclean hands defense.
These discovery documents were governed by a Second Amended Protective Order
Governing Confidentiality to which the parties agreed16 and the Court entered on
March 28, 2008. By its terms, the Protective Order governed “discovery and the
pre-trial stage of this litigation[,]” but did “not address the introduction of any
evidence at the final trial of this matter or the reference to any information in open
court at the final trial of this matter.” Moreover, the Court entered the Protective
Order pursuant to Federal Rule of Civil Procedure 26(c) which provides for the
entry of an order for good cause protecting a party or person during discovery.
“Once the documents [sealed under the Protective Order governing discovery] are
made part of a dispositive motion, they lose their status of being raw fruits of

16

At the time of the agreement, Agan Chemical Manufacturers, Ltd. (“Agan”)
was awaiting decision from the Court on its motion to dismiss for insufficient
service of process. See Dock. 277. Therefore, Agan was not a party to the
Second Amended Protective Order Governing Confidentiality.
37

discovery.” Rushford, 846 F.2d 249, 252 (internal citations omitted); see also id.
(“[Pre-trial] discovery, which is ordinarily conducted in private, stands on a wholly
different footing than does a motion filed by a party seeking action by the court.”).
Although the Fourth Circuit has recognized that there may be times when
discovery documents should remain sealed even after their submission as part of a
dispositive motion, id. at 253, Syngenta has not made a sufficient showing that its
interests override the public right of access under either the common law or First
Amendment doctrines of public access.17 While Syngenta argues in opposition to
MANA’s motion to unseal that the confidential documents “contain sensitive and
valuable confidential business information regarding Syngenta’s internal decisionmaking and strategy regarding business, regulatory, and legal analysis and
decisions,” the Court does not find that the confidential memoranda reveal
information damaging to Syngenta. Instead, the documents, now over a decade
old, contain innocuous business plans that, not only fail to support the unclean
hands doctrine, but also do not reveal strategies unique to Syngenta. The
documents certainly provide no information which would benefit a competitor nor
otherwise harm Syngenta. Therefore, it is determined that MANA’s motion to

17

MANA filed its motion to unseal on April 28, 2008, and Syngenta filed its
opposition to the motion on May 22, 2008 to which MANA replied on June 6,
2008. See Docks. 342, 359, 360. The public and other interested parties have
had ample notice of MANA’s and Syngenta’s positions and have not commented
on the issue. See Va. Dep’t of State Police v. Washington Post, 386 F.3d 567,
576 (4th Cir. 2004) (describing the procedure the district court must follow in
determining whether or not to seal documents).
38

dismiss for lack of subject matter jurisdiction, Dock. 317, and memorandum in
support of its motion along with the attached exhibits, Dock. 318, should be
unsealed.
IV. Summary Judgment Motions - Arbitrary and Capricious Agency Action
In this case, the Court is reviewing the decision of EPA, the finder of fact, to
determine summary judgment. This is different than determining summary
judgment in an original district court proceeding. Occidental Eng’g Co. v. INS, 753
F.2d 766, 770 (9th Cir. 1985). Here, “summary judgment is an appropriate
mechanism for deciding the legal question of whether the agency could reasonably
have found the facts as it did.” Id. “‘[T]he focal point for judicial review should be
the administrative record already in existence’ . . . [that] the agency presents to
the reviewing court.” Fla. Power & Light Co. v. Lorion, 470 U.S. 729, 743-44
(1985) (quoting Camp v. Pitts, 411 U.S. 138, 142 (1973) and citing Citizens to
Pres. Overton Park v. Volpe, 401 U.S. 402 (1971)). This record need not be the
product of a formal hearing, but may instead be compiled by the agency during the
course of its informal action. Id. at 744.
When reviewing agency actions under the APA, a court will set aside agency
actions or find them unlawful only when they are “found to be . . . arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with the law.” 5
U.S.C. § 706(2)(A). This narrow review is “highly deferential, with a presumption
in favor of finding the agency action valid.” Ohio Valley Envtl. Coal. v. Aracoma
39

Coal Co., 556 F.3d 177, 192 (4th Cir. 2009); see also Thomas Jefferson Univ. v.
Shalala, 512 U.S. 504, 512 (1994) (stating a court must give substantial
deference to an agency’s interpretation of its own regulations unless an
“alternative reading is compelled by the regulation’s plain language or by other
indications of the [agency’s] intent at the time of the regulation’s promulgation”)
(internal citations omitted). This is especially true when “the regulation concerns
‘a complex and highly technical regulatory program,’ in which the identification and
classification of relevant ‘criteria necessarily require significant expertise and entail
the exercise of judgment grounded in policy concerns.’” Thomas Jefferson Univ.,
512 U.S. at 512 (quoting Pauley v. BethEnergy Mines, Inc., 501 U.S. 680, 697
(1991)). Nonetheless, the court must engage in a “searching and careful” inquiry
that “educate[s] the court” so it may “understand enough about the problem
confronting the agency to comprehend the meaning of the evidence relied upon
and the evidence discarded; the questions addressed by the agency and those
bypassed; the choices open to the agency and those made.” Ohio Valley Envtl.
Coal., 556 F.3d at 192-93 (quoting Ethyl Corp. v. EPA, 541 F.2d 1, 34 (D.C.Cir.
1976)).
Agency action is arbitrary and capricious
if the agency has relied on factors which Congress had not intended it
to consider, entirely failed to consider an important aspect of the
problem, offered an explanation for its decision that runs counter to
the evidence before the agency, or is so implausible that it could not
be ascribed to a difference in view or the product of agency expertise.
40

Ohio River Valley Envtl. Coal., Inc. v. Kempthorne, 473 F.3d 94, 102 (4th Cir.
2006) (quoting Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463
U.S. 29, 43 (1983)). The agency needs to have examined the relevant data and
provided an explanation of its determination that includes “a ‘rational connection
between the facts found and the choice made.’” Ohio Valley Envtl. Coal., 556 F.3d
at 192 (quoting Motor Vehicle Mfrs. Ass’n, 463 U.S. at 43 (1983) (internal
citations omitted)). The agency must have provided the explanation at the time of
its action, and neither the court nor the agency may do so on appeal. Inova
Alexandria Hosp. v. Shalala, 244 F.3d 342, 350 (4th Cir. 2001).
A. Count I
Syngenta alleges that the studies it submitted in support of its s-metolachlor
registration were exclusive use studies and EPA violated its exclusive use rights by
permitting the Metolachlor Registrants to rely on two of those studies in support of
their me-too registrations. While, for the following reasons, the Court finds the
studies Syngenta submitted in support of its s-metolachlor registration to be
exclusive use studies,18 EPA did not violate Syngenta’s exclusive use rights. EPA
18

In his memorandum explaining EPA’s me-too registration of Cedar’s
Technical Metolachlor, EPA’s Herbicide Branch Chief stated that Cedar’s me-too
application did not rely on any data that Syngenta submitted for s-metolachlor. AR
211. “For this reason, [Herbicide Branch] did not need to determine whether the
Syngenta S-Metolachlor studies are entitled to exclusive use treatment.” Id.
However, in a footnote, the Chief declares that the studies would not be
considered exclusive use studies because they were required to maintain in effect
an existing registration. Id. Although agency determinations are due deference,
41

did not act arbitrarily and capriciously when registering the Metolachlor Registrants’
me-too pesticides as its actions pertain to the allegations in Count I of the SASC.
Thus, summary judgment in favor of EPA, Drexel, and Sipcam for Count I is
appropriate.
Syngenta applied to register s-metolachlor under EPA’s reduced risk
initiative. AR 291. As part of its data in support of the registration, Syngenta used
bridging data from studies submitted for metolachlor’s registration. Id.; AR 11. On
March 14, 1997, EPA conditionally registered s-metolachlor with an expiration
date of February 14, 1998. AR 211 att. After registering s-metolachlor, EPA
continued to evaluate the sufficiency of bridging data Syngenta used to support smetolachlor. AR 11; see also AR 14 (clarifying EPA’s April 11, 1997 review of
data submitted for s-metolachlor) and AR 17 (explaining that Syngenta received in
May 1997 a review of the environmental fate studies it submitted in January 1996
as part of its s-metolachlor registration). When EPA agreed in its February 6,
1998 letter to Syngenta to remove s-metolachlor’s registration expiration, it
required the submission of studies that had been part of the communications
between EPA and Syngenta. AR 15 (noting that Syngenta had already responded
to data gaps for environmental fate studies such as field dissipation studies with
terrestrial and turf studies but that its response was pending EPA review); AR 12

this particular EPA determination is found only in a footnote to a sentence that
acknowledged the Herbicide Branch itself did not determine whether Syngenta’s
studies were exclusive use studies.
42

(discussing the need for rat metabolism and side-by-side subchronic studies); AR
14 (clarifying the requirement for avian reproduction studies, fathead minnow lifecycle and early life stage study, daphnia 21-day flow-thru study, acute fish
sheepshead minnow study, acute mysid shrimp study, and acute molluskC.virginica study). Although Syngenta refers to several required studies, including
the fathead minnow life cycle and early life stage study, as “new data
requirements” in its July 2, 1998 letter to EPA, these requirements were not new
to the conversation between EPA and Syngenta that took place over the course of
the prior year concerning data submission. See, e.g., AR 14. Instead, the studies
required of Syngenta, in particular the fathead minnow life-cycle and early life
stage study and the terrestrial field dissipation study, had been part of EPA’s
review of the bridging data Syngenta submitted in support of s-metolachlor’s
registration. Those studies and others would continue to be debated between EPA
and Syngenta. See, e.g., AR 23 (detailing EFED’s completed review in late 1998 of
ecological testing requirements for s-metolachlor).
Admittedly, EPA’s explicit requirement in its February 6, 1998 letter to
Syngenta of the submission of particular studies, including the fathead minnow lifecycle and early life stage study and the terrestrial field dissipation study, comes
after the March 14, 1997 conditional registration of s-metolachlor. However, this
chronology does not necessarily mean that the studies Syngenta submitted as a
result of the February 6, 1998 letter are defensive data. These studies were not
43

submitted as a result of EPA’s determination that additional data was necessary to
maintain in effect an existing registration, see 7 U.S.C. § 136a(c)(2)(B), such as
the early 1990's Data Call-Ins EPA issued to all metolachlor registrants. Instead,
detailed review of the communications between EPA and Syngenta reveal that the
required studies became necessary after EPA determined bridging data used to
register s-metolachlor was insufficient. The initial expedited review pursuant to the
reduced risk initiative of s-metolachlor permitted EPA to register s-metolachlor
according to 7 U.S.C. § 136a(c)(7)(C), which states, in relevant part
The Administrator may conditionally register a pesticide
containing an active ingredient not contained in any currently
registered pesticide for a period reasonably sufficient for the
generation and submission of required data [on certain conditions]. A
conditional registration under this subparagraph shall be granted only
if the Administrator determines that use of the pesticide during such
period will not cause any unreasonable adverse effect on the
environment, and that use of the pesticide is in the public interest.
Syngenta’s fathead minnow life-cycle and early life stage study and the
terrestrial field dissipation study (1) pertained to a new active ingredient first
registered after September 30, 1978, (2) were submitted in support of, or as a
condition of approval of, the application resulting in the first registration of a
product containing such new chemical, and (3) were not submitted to maintain an
existing registration. See 40 C.F.R. § 152.83. Therefore, the studies are exclusive
use studies for the ten-year period following the date of first registration. Id.
Although Syngenta’s fathead minnow and terrestrial field dissipation studies
were exclusive use studies, Syngenta’s exclusive use rights were not violated
44

because EPA did not use Syngenta’s studies when it registered the Metolachlor
Registrants’ me-too pesticides. EPA’s EFED drafted a “note to file” in February
2002 stating “selected ecotoxicity data19 for s-metolachlor were used to satisfy
data requirements for metolachlor.” AR 177. However, in March 2002, EPA’s
EFED drafted a “note to file - clarification” in which it explained that the question
of whether certain ecotoxicity and environmental fate studies that Syngenta
submitted for s-metolachlor could be used to assess ecotoxicity and fate of
metolachlor was “posed from a scientific perspective.” AR 197. “It was not [the
EFED’s] intent to give an opinion as to whether certain Syngenta ecotoxicty studies
conducted on S-Metolachlor fulfilled any data requirements for Metolachlor.” Id. In
addition, the Herbicide Branch Chief stated in his memorandum explaining the
registration of Cedar’s me-too pesticide that Cedar’s application did not rely on any
data that Syngenta had submitted in support of s-metolachlor’s registration. AR
211.
Moreover, neither the fathead minnow life-cycle and early life stage study
nor the terrestrial field dissipation study were listed as data gaps in the RED for
metolachlor. See AR 7 (listing 72-4A Early Life Stage Fish with a citation study
number and 164-1 Terrestrial Field Dissipation with three citation study numbers).
EPA required Syngenta to submit the studies for s-metolachlor, though, because s-

19

Ecotoxicity data includes the fathead minnow life-cycle and early life stage
study. Syngenta’s Br. Supp. Mtn. S.J. 11.
45

metolachlor was registered as a new active ingredient using bridging data for
metolachlor. AR 211, att.; AR 291. In its review of sufficient data for bridging
purposes, EPA determined the fathead minnow study performed for metolachlor
was supplemental and could not be bridged. AR 14. EPA found discrepancies in
the original and new metolachlor bridging data for the environmental fate studies,
of which the terrestrial field dissipation is one. AR 17. Ultimately, EPA required
Syngenta to submit both studies for s-metolachlor’s registration. AR 15.
When EPA conditionally registered the Metolachlor Registrants’ me-too
metolachlor pesticides, EPA did not require the submission of the fathead minnow
life-cycle and early life stage study or the terrestrial field dissipation study. This
was not because, as Syngenta argues, EPA was relying on Syngenta’s studies to
satisfy those two requirements. Instead, as noted above, those two studies were
not data gaps for metolachlor.20 Consequently, they were not required in order to

20

In a memorandum drafted after its February 5, 1998 memorandum, EFED
updated its review of the ecological effects data. AR 215. When explaining that
EFED needed satisfactory chronic testing for fish and invertebrates with smetolachlor, EFED stated “EFED presently has no valid chronic aquatic data for
metolachlor or s-metolachlor. All studies with metolachlor (fish and invertebrate)
were found to be invalid or supplemental.” Id. EFED further states “no fully
acceptable chronic data for either of the two chemicals” exists so “no true chronic
risk potential for s-metolachlor can be predicted.” Id. Syngenta argues that this
evidences a data gap for metolachlor for the fish chronic aquatic data which
includes the fathead minnow study. However, this EFED analysis is in the context
of permitting Syngenta to use bridging data from metolachlor for s-metolachlor, a
new active ingredient. In that context, EFED found the chronic fish study to be
invalid or supplemental and not fully acceptable. This does not mean, however,
that EPA would find the study necessary for a me-too metolachlor registration.
46

register the me-too metolachlor pesticides.
Since EPA was not relying on Syngenta’s studies submitted in support of smetolachlor when it registered the Metolachlor Registrants’ me-too pesticides, EPA
was not required to provide thirty days notice to Syngenta. Such notice is required
before EPA registers a product containing an active ingredient for which a
previously submitted study is eligible for exclusive use. 40 C.F.R. § 152.116(a).
However, the Metolachlor Registrants’ me-too applications and registrations did not
rely on any of Syngenta’s s-metolachlor studies. Therefore, Syngenta was not due
thirty days notice.
In sum, although Syngenta’s studies submitted in support of s-metolachlor
were exclusive use studies, they were not used in support of the Metolachlor
Registrants’ me-too pesticide registrations. The administrative record is replete
with evidence, see, e.g., supra pp. 42-46, that EPA examined the relevant facts as
it determined what data were sufficient for Syngenta to bridge with s-metolachlor,
what data were gaps for metolachlor, and ultimately what data were required of
Syngenta and the Metolachlor Registrants. The record provides an explanation
that reflects a rational connection between the facts found and the choice made.
Therefore, not only did EPA not violate Syngenta’s exclusive use rights under
FIFRA, but it also did not act arbitrarily and capriciously. It is determined that
EPA’s motion for summary judgment and Drexel’s motion for summary judgment,
which Sipcam joins, for Count I be granted and that Syngenta’s motion for
47

summary judgment for Count I be denied.
B. Count II
Because Syngenta only has standing to pursue the claim in paragraph 188 —
as reiterated in paragraphs 189 and 193 — of Count II, the Court’s review for
summary judgment focuses only on Syngenta’s assertions concerning EPA’s delay
in cancelling Syngenta’s technical metolachlor registration while EPA reviewed and
ultimately registered the Metolachlor Registrants’ me-too pesticides. Although EPA
admittedly delayed cancelling Syngenta’s technical metolachlor registration while
the Metolachlor Registrants’ me-too applications were pending, EPA did not act
arbitrarily and capriciously in doing so.
Syngenta resubmitted its request for voluntary cancellation of its technical
metolachlor registration in September 1999. AR 293. 7 U.S.C. § 136d(f)(1)(A)
provides that Syngenta may, at any time, request EPA to cancel its metolachlor
registrations. The statute dictates that, upon receipt of cancellation request, EPA
must publish in the Federal Register notice of such receipt for either a 30-day or
180-day period. 7 U.S.C. § 136d(f)(1)(B), (C). EPA published notice beginning in
December 1999 for a 180-day period. AR 294. During the period for public
comment, Cedar applied for a me-too technical metolachlor registration based on
Syngenta’s technical metolachlor registration and submitted objections to the
cancellation of Syngenta’s registration. AR 29; AR 297. Once the period for public
comment ended in June 2000, EPA “may [have] approve[d] or den[ied]
48

[Syngenta’s cancellation] request.” 7 U.S.C. § 136d(f)(1)(D). But, the statute does
not require that EPA act within any period of time, nor does the statute require EPA
to approve the cancellation at all.
Not only does the statute not require cancellation, but EPA determined that
delaying cancellation of Syngenta’s technical metolachlor registration was
consistent with FIFRA. In its communications with Syngenta, EPA noted that it
“will continue to leave Syngenta’s Technical Metolachlor registration in effect until
EPA completes its review of all pending me-too applications to register metolachlor.
[EPA] believe[s] this is consistent with the purpose of the procedures set forth in
FIFRA § 6(f).” AR 303; see 7 U.S.C. 136d(f) (procedures for voluntary
cancellation). Deference is given to EPA’s interpretation of the purpose of the
voluntary cancellation procedures. The statute’s plain language does not does not
demand a different reading. See Thomas Jefferson Univ., 512 U.S. at 512 (noting
no deference afforded when plain language compels alternate reading). Instead,
the statute involves a “complex and highly technical regulatory program” that
“require[s] significant expertise and entails the exercise of judgment grounded in
policy concerns.” Id.
EPA expressed its opinion about the purpose of the voluntary cancellation
procedures to Syngenta. In April 2002, EPA responded to Syngenta’s inquiry
concerning its cancellation request. AR 303. In its response, EPA stated that its
earlier communications with Syngenta concerning Syngenta’s cancellation request
49

were not intended “to commit the Agency to making decisions on Cedar’s me-too
applications or Syngenta’s voluntary cancellation request by a date certain.” Id.
Instead, EPA wrote that the intent of its earlier communication with Syngenta was
“to ensure that Syngenta would continue to have the option of continued access to
the Metolachlor market in the event Cedar’s application was granted, and that
Syngenta would have notice about the Agency’s approach to its voluntary
cancellation in the same time frame as any Agency action on the then-pending
Cedar applications.” Id. Since EPA granted Cedar’s, Sipcam’s, and Drexel’s me-too
metolachlor registrations in March and April 2002, EPA offered Syngenta the
opportunity to withdraw its voluntary cancellation request in order to remain in the
market. Id.; AR 304. However, if EPA did not receive a withdrawal request from
Syngenta, EPA was prepared to cancel Syngenta’s technical metolachlor
registration since “the purpose of the FIFRA § 6(f) procedures [had] been served”
with the registrations of the me-too pesticides. AR 304. Syngenta did not submit
a withdrawal request, and EPA cancelled Syngenta’s technical metolachlor
registration in August 2002. Dock. 330, Ex. 3.
Affording discretion to EPA’s understanding of FIFRA and the purpose
behind its procedures, the Court determines EPA’s actions in delaying the
cancellation of Syngenta’s technical metolachlor registration were not arbitrary and
capricious. Therefore, EPA’s motion for summary judgment and Sipcam’s motion
for summary judgment, which Drexel joins, are granted as to Count II, and
50

Syngenta’s motion for summary judgment as to Count II is denied.
C. Count III
Even had the Court determined that Syngenta had standing to pursue its
equal protection claim in Count III, summary judgment in favor of EPA, Drexel, and
Sipcam would be mandated. Syngenta alleges in Count III that “EPA has taken
actions, including its refusal to cancel Syngenta’s registration of metolachlor, by
which it has intentionally treated Syngenta differently from similarly situated
persons regulated under FIFRA and thereby discriminated against Syngenta.”
Syngenta is unable to support its allegations.
In order to succeed on this claim, Syngenta “must first demonstrate that [it]
has been treated differently from others with whom [it] is similarly situated and
that the unequal treatment was the result of intentional or purposeful
discrimination.” Morrison v. Garraghty, 239 F.3d 648, 654 (4th Cir. 2001). If
Syngenta were able to make this showing, the Court would then “determine
whether the disparity in treatment can be justified under the requisite level of
scrutiny.” Id. Syngenta, however, is unable to overcome the first hurdle of
demonstrating that EPA treated Syngenta differently from others similarly situated.
The class similarly situated to Syngenta would be pesticide manufacturers
who sought voluntary cancellation of their registrations prior to the submission of

51

me-too applications.21 The only similarly situated pesticide manufacturer is
Sergeant’s.22 Sergeant’s sought voluntary cancellation of products containing
naled on September 28, 2001. EPA’s Resp. Syngenta’s 2nd Interrogs. & Reqs. 23
[Dock. 316, Att. 11]. During the thirty-day notice and comment period, Amvac
submitted a me-too application based on Sergeant’s naled products. Id. at 24.
“Because EPA could not grant (under section 3(c)(7)(A) of FIFRA) Amvac’s pending
me-too application after canceling Sergeant’s registrations, EPA delayed acting on
Sergeant’s cancellation request so that it would have time to evaluate whether the

21

Syngenta also argues EPA treated it differently than other pesticide
registrants who failed to pay annual maintenance fees. Although Syngenta cites to
the Federal Register announcing cancellation of hundreds of registrations for failure
to pay maintenance fees with the exception of Syngenta’s registration and to the
deposition of John Jamula where he states “generally [EPA] cancel[s] the product”
when a registrant indicates it is not going to pay the maintenance fee, Syngenta
does not provide evidence that those registrations had pending me-too applications
dependent upon the continuation of the registrations. See 66 Fed. Reg. 38675
(July 25, 2001) [Dock. 326, Ex. 2]; 67 Fed. Reg. 54114 (Sept. 6, 2000) [Dock.
337, Ex. 5]; Dep. J. Jamula 24:11-15 [Dock. 321, Ex. 8].
22

The only other situation in which manufacturers sought voluntary
cancellation when me-too applications were involved was not similar to Syngenta’s
situation. On June 30, 2003 Osmose submitted a request for voluntary
cancellation of its product containing chromic acid and cupric oxide (ACC). EPA’s
Resp. Syngenta’s 2nd Interrogs. & Reqs. 31. Six days prior, on June 24, 2003,
Forest Products Research Laboratory submitted a me-too application based on
Osmose’s ACC registration. Id. Like in Syngenta’s and Sergeant’s situations, EPA
did delay cancelling Osmose’s registration in order to review the pending me-too
application. Id. However, not only did Osmose request cancellation after the metoo application had been filed, but Osmose ultimately withdrew its cancellation
request. Id. at 32. Nonetheless, while the me-too application was pending, EPA
did not cancel Osmose’s ACC registration. Id. Thus, EPA did not treat Osmose
differently than Syngenta.
52

pending me-too applications met section 3(c)(7)(A) standard for registration.” Id.
As of August 2004, EPA had not cancelled the naled registrations, nearly three
years after Sergeant’s requested voluntary cancellation and approximately two and
a half years after Amvac submitted its me-too application. Id. As of the date of
EPA’s Response to Syngenta’s Second Set of Interrogatories and Requests for
Documents,23 EPA was unable to determine whether and, if so, when Sergeant’s
products containing naled were cancelled. Id. Further, the me-too applications
were still pending because of concerns of risk to humans. Id.

There is no evidence

EPA treated Syngenta differently than Sergeant’s by cancelling Sergeant’s
registrations for products containing naled pending review of me-too applications.
To the contrary, the evidence before the Court shows EPA treated Sergeant’s and
Syngenta similarly - delaying their voluntary cancellation requests in order to review
and perhaps ultimately register the me-too pesticide applications.
Because Syngenta cannot show that EPA treated it differently than others
similarly situated, it is unable to support a claim for denial of equal protection
rights.
VI. Conclusion
For the reasons stated above, IT IS HEREBY ORDERED that Sipcam’s motion
for summary judgment on Syngenta’s claim of arbitrary and capricious agency
action in violation of the Administrative Procedure Act [Dock. 308], which Drexel

23

November 29, 2007.
53

joins, is GRANTED, that Drexel’s motion for summary judgment on Syngenta’s
claim of EPA action in violation of the Equal Protection Clause and violation of
FIFRA’s exclusive use provisions [Dock. 312], which Sipcam joins, is GRANTED,
that EPA’s motion for summary judgment on all Counts [Dock. 316] is GRANTED,
that MANA’s motion to dismiss for lack of subject matter jurisdiction [Dock. 317],
which Sipcam and Drexel join, is GRANTED IN PART AND DENIED IN PART, that
Syngenta’s motion for summary judgment on all Counts [Dock. 319] is DENIED,
and that MANA’s motion to unseal its motion to dismiss and memorandum in
support of its motion to dismiss [Dock. 342] is GRANTED.
This, the 9th day of August, 2011.

/s/ N. Carlton Tilley, Jr.
Senior United States District Judge

54