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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE NORTHERN DISTRICT OF CALIFORNIA
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`Case No. 13-cv-01266-MMC
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`ORDER GRANTING IN PART AND
`DENYING IN PART PLAINTIFFS'
`MOTION FOR SUMMARY JUDGMENT;
`GRANTING IN PART AND DENYING IN
`PART DEFENDANTS' MOTIONS FOR
`SUMMARY JUDGMENT; DIRECTIONS
`TO PARTIES
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`STEVE ELLIS, ET AL.,
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`Plaintiffs,
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`v.
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`JACK HOUSENGER, et al.,
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`Defendants,
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` and
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`BAYER CROPSCIENCE, LP, et al.,
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`Defendant-Intervenors.
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`Before the Court are three motions: (1) "Motion for Summary Judgment," filed
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`April 14, 2016, by plaintiffs Steve Ellis, Tom Theobald, Jim Doan, Bill Rhodes, Center for
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`Food Safety, Beyond Pesticides, Sierra Club and Center for Environmental Health;
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`(2) "Cross-Motion for Summary Judgment," filed June 7, 2016, by defendants Gina
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`McCarthy, Administrator of the United States Environmental Protection Agency, and Jack
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`Housenger, Director of the Office of Pesticide Programs of EPA (collectively, "EPA"); and
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`(3) "Cross-Motion for Summary Judgment," filed June 20, 2016, by defendant-intervenors
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`Bayer CropScience LP, Syngenta Crop Protection, LLC, Valent U.S.A. Corporation, and
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`CropLife America (collectively, "Intervenors"). The motions have been fully briefed.
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`Having read and considered the papers filed in support of and in opposition to the
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`motions, the Court hereby rules as follows.1
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`1By order filed October 25, 2016, the Court took the matters under submission.
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`Northern District of California
`United States District Court
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`Case 3:13-cv-01266-MMC Document 269 Filed 05/08/17 Page 2 of 39
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`By the instant action, plaintiffs, comprising four individuals and four public interest
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`BACKGROUND
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`groups, "challenge the actions of [the EPA] to allow the ongoing use of pesticide products
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`containing the active ingredients clothianidin and thiamethoxam." (See Second
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`Amended Complaint (“SAC”) ¶ 1.) Plaintiffs allege the subject pesticides "have been
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`shown to adversely impact the survival, growth, and health of honey bees and other
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`pollinators vital to U.S. agriculture" and have "harmful effects on other animals, including
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`threatened and endangered species." (See SAC ¶ 2.)
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`More specifically, plaintiffs allege that the EPA failed to comply with the Federal
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`Insecticide, Fungicide, and Rodenticide Act ("FIFRA") by denying plaintiffs' request, made
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`in a petition submitted to the EPA, to suspend the registration of products containing
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`clothianidin (see SAC ¶¶ 82, 104, 110), and by approving applications to register certain
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`products containing clothianidin or thiamethoxam without first providing notice in the
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`Federal Register (see SAC ¶¶ 37, 114, 121). Additionally, plaintiffs allege that the EPA
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`violated the Endangered Species Act ("ESA") by failing to consult with the Fish and
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`Wildlife Service ("FWS") prior to approving certain applications to register products
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`containing clothianidin and thiamethoxam. (See SAC ¶¶ 49-50, 128, 132.)
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`LEGAL STANDARD
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`Northern District of California
`United States District Court
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`Pursuant to Rule 56 of the Federal Rules of Civil Procedure, a "court shall grant
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`summary judgment if the movant shows that there is no genuine issue as to any material
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`fact and that the movant is entitled to judgment as a matter of law." See Fed. R. Civ. P.
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`56(a).
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`The Supreme Court's 1986 "trilogy" of Celotex Corp. v. Catrett, 477 U.S. 317
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`(1986), Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986), and Matsushita Electric
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`Industrial Co. v. Zenith Radio Corp., 475 U.S. 574 (1986), requires that a party seeking
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`summary judgment show the absence of a genuine issue of material fact. Once the
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`moving party has done so, the nonmoving party must "go beyond the pleadings and by
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`[its] own affidavits, or by the depositions, answers to interrogatories, and admissions on
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`Case 3:13-cv-01266-MMC Document 269 Filed 05/08/17 Page 3 of 39
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`file, designate specific facts showing that there is a genuine issue for trial." See Celotex,
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`477 U.S. at 324 (internal quotation and citation omitted). "When the moving party has
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`carried its burden under Rule 56[ ], its opponent must do more than simply show that
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`there is some metaphysical doubt as to the material facts." Matsushita, 475 U.S. at 586.
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`"If the [opposing party's] evidence is merely colorable, or is not significantly probative,
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`summary judgment may be granted." Liberty Lobby, 477 U.S. at 249-50 (citations
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`omitted). "[I]nferences to be drawn from the underlying facts," however, "must be viewed
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`in the light most favorable to the party opposing the motion." See Matsushita, 475 U.S. at
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`587 (internal quotation and citation omitted).
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`DISCUSSION
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`All parties seek summary judgment on the issue of liability as to the six claims
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`alleged in the SAC.2
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`A. First and Second Claims
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`The First and Second Claims challenge the EPA's denial of a request made in a
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`petition that was submitted to the EPA by four of the plaintiffs, specifically, a request to
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`immediately suspend the registration of products containing clothianidin.
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`1. Applicable Statutory and Regulatory Framework
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`Under FIFRA, no pesticide may be distributed or sold unless it has been registered
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`by the EPA. See 7 U.S.C. § 136a(a). If, after the EPA registers a pesticide, it "appears
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`to the [EPA] that a pesticide . . . generally causes unreasonable adverse effects on the
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`environment," the EPA may issue a notice of intention "to cancel its registration or to
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`change its classification." See 7 U.S.C. § 136d(b). If the EPA issues a notice of intention
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`to cancel or change the classification of a registration, "a person adversely affected by
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`the notice" may request a hearing, see 7 U.S.C. § 136d(b)(2), which hearing is conducted
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`2In their cross-motion for summary judgment, the Intervenors join in the EPA’s
`cross-motion for summary judgment (see Intervenors' Cross-Mot. at 1:2-3); accordingly,
`the Court’s rulings on the arguments made by the EPA pertain equally to the Intervenors.
`Where the Intervenors have made arguments in addition to those made by the EPA, the
`Court has separately addressed those arguments herein.
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`Northern District of California
`United States District Court
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`Case 3:13-cv-01266-MMC Document 269 Filed 05/08/17 Page 4 of 39
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`by an administrative law judge, see 40 C.F.R. § 164.20(c). "[C]ancellation or
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`reclassification proceedings may take one or two years to complete." Love v. Thomas,
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`858 F.2d 1347, 1350 (9th Cir. 1988), cert. denied, 490 U.S. 1035 (1989)
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` "If the [EPA] determines that action is necessary to prevent an imminent hazard
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`during the time required for cancellation or change in classification proceedings, the
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`[EPA] may, by order, suspend the registration of the pesticide immediately." 7 U.S.C.
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`§ 136d(c)(1). The term "imminent hazard" is defined as "a situation which exists when
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`the continued use of a pesticide during the time required for [a] cancellation proceeding
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`would be likely to result in unreasonable adverse effects on the environment or will
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`involve unreasonable hazard to the survival of a species declared endangered or
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`threatened." See 7 U.S.C. § 136(l). The term "unreasonable adverse effects on the
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`environment" is defined as "any unreasonable risk to man or the environment, taking into
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`account the economic, social, and environmental costs and benefits of the use of any
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`pesticide." See 7 U.S.C. § 136(bb).
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`Subject to one exception, discussed below, the EPA may not issue an order of
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`suspension unless it has "issued, or at the same time issues, a notice of intention to
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`cancel the registration or change the classification of the pesticide" and "notif[ies] the
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`registrant prior to issuing any suspension order." See 7 U.S.C. § 136d(c)(1). If the
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`registrant does not request a hearing within five days, the "suspension order may be
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`issued and shall take effect." See 7 U.S.C. § 136d(c)(2). If the registrant timely requests
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`a hearing, the EPA conducts an "expedited hearing . . . on the question of whether an
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`imminent hazard exists." See 7 U.S.C. §§ 136d(c)(1). Following the expedited hearing,
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`the EPA "shall issue a final decision and order" addressing the issue of suspension. See
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`40 C.F.R. § 164.122(a). The "administrative suspension process" may take three to four
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`months to complete. See Dow Chemical Co. v. Blum, 469 F. Supp. 892, 899, 902 (E.D.
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`Mich. 1979); see also Love, 858 F.2d at 1353 n.10 (noting "suspension hearing would
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`require approximately four months").
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`//
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`Case 3:13-cv-01266-MMC Document 269 Filed 05/08/17 Page 5 of 39
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`The one instance in which the EPA may suspend a registration prior to issuing a
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`notice of intention to cancel and prior to notifying the registrant is where "the [EPA]
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`determines that an emergency exists that does not permit the [EPA] to hold a hearing
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`before suspending." See 7 U.S.C. § 136d(c)(3). Upon issuing an "emergency" order of
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`suspension, see 40 C.F.R. § 164.123(a), the EPA must, however, "immediately notify the
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`registrant," who, in turn, may request an expedited hearing on the question of whether an
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`imminent hazard exists, see 40 C.F.R. § 164.123(b). Such "emergency order" of
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`suspension remains in place pending the conclusion of the administrative suspension
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`process. See 7 C.F.R. § 136d(c)(3); 40 C.F.R. § 164.123(b); see also National Coalition
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`Against the Misuse of Pesticides v. EPA, 867 F.2d 636, 644 (D.C. Cir. 1989) (holding
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`"[t]he extraordinary step of emergency suspension is available only if the requisite
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`unreasonable harm would be likely to materialize during the pendency of ordinary
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`suspension proceedings").
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`2. Administrative Proceedings Conducted on Plaintiffs' Petition
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`On March 20, 2012, plaintiffs Steve Ellis, Tom Theobald, the Center For Food
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`Safety, and Beyond Pesticides, along with other individuals and entities who are not
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`parties to the instant action, jointly submitted to the EPA an "Emergency Citizen Petition"
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`("Petition"). (See Administrative Record ("AR") 44323-44370.) In the Petition, plaintiffs
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`requested that the EPA, inter alia, suspend clothianidin's registration "on an emergency
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`basis," or, alternatively, "promptly initiate Special Review and cancellation procedures for
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`clothianidin pursuant to 7 U.S.C. § 136d[,] and then suspend its registration pending
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`completion of the cancellation procedures based on the ongoing and imminent harm
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`posed." (See AR 44327.) 3 Thereafter, in support of the Petition, plaintiffs submitted
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`3The EPA may institute a "Special Review" to "help the [EPA] determine whether
`to initiate procedures to cancel . . . or reclassify registration of a pesticide product." See
`40 C.F.R. § 154.1(a). The EPA may initiate a Special Review “on [its] own initiative” or
`“at the suggestion of any interested party” who submits a “petition[ ] to begin the Special
`Review process.” See 40 C.F.R. § 154.10; see also 40 C.F.R. § 154.7 (identifying
`“criteria for initiation of Special Review”). During the Special Review process, the EPA
`creates a "docket," provides an opportunity for the registrant and others to submit
`comments, and conducts, if it deems such proceedings appropriate, "informal public
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`Northern District of California
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`Case 3:13-cv-01266-MMC Document 269 Filed 05/08/17 Page 6 of 39
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`supplemental filings dated, respectively, May 3, 2012, and June 18, 2012. (See AR
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`44598-618.)
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`On July 17, 2012, the EPA issued a responsive letter, denominated a "partial
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`response" ("Partial Response"). (See AR 44419-30.) The EPA explained therein that it
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`was posting on its website for public comment "the [P]etition (including the [P]etition
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`exhibits and supplemental filings)," its Partial Response thereto (see AR 44419), and
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`"additional materials from other sources" (see AR 44420). The EPA then denied the
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`request for an emergency order of suspension and stated it would respond to the other
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`requests made in the Petition "[a]fter reviewing the public comments submitted." (See
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`AR 44419.)
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`In denying an immediate suspension, the EPA found the Petition suffered from a
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`"facial inadequacy," specifically, the lack of "an explanation as to how the harm identified
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`outweigh[ed] the benefits to growers and the agricultural economy from the use of the
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`pesticide" (see AR 44423-24), and that, in any event, "nowhere in the [P]etition [did]
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`[plaintiffs] explain how the use of clothianidin rises to the level of the FIFRA imminent
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`hazard standard" (see AR 44424; see also AR 44425-30).4 In setting forth said findings,
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`the EPA stated that, "due to the emergency nature of [the] request," it had only
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`considered the materials "received prior to May 4, 2012" (see AR 44420), and that it
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`would consider plaintiffs' supplemental filings, namely, those dated May 3, 2012, and
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`June 18, 2012, along with the "additional materials from other sources," once it had
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`received the public comments, and thereafter would determine whether reconsideration
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`was warranted (see AR 44419).5
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`hearings." See 40 C.F.R. §§ 154.15, 154.26, 154.29. At the conclusion of a Special
`Review, the EPA may, inter alia, issue notice of its intention to cancel a registration or to
`change the classification of a registration. See 40 C.F.R. § 154.33(a).
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`4With respect to the latter basis for its denial, the EPA attached to the Partial
`Response a 30-page "Technical Support Document" in which it set forth a detailed
`analysis of the studies cited in the Petition. (See AR 44431-60.)
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`5The administrative record does not indicate whether, and if so when, the EPA
`ruled on the remaining requests in the Petition.
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`Northern District of California
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`Case 3:13-cv-01266-MMC Document 269 Filed 05/08/17 Page 7 of 39
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`3. Merits of First and Second Claims
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`In the First Claim, plaintiffs allege it was "arbitrary and capricious" for the EPA,
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`when ruling on plaintiffs' request for an immediate suspension, not to consider plaintiffs'
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`"supplemental filings." (See SAC ¶ 104.) In the Second Claim, plaintiffs allege the
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`"EPA's failure to suspend the registrations of [clothianidin] products in view of their
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`unreasonable adverse effects violates FIFRA." (See SAC ¶ 110.)
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`District courts have jurisdiction to review "the refusal of the [EPA] to cancel or
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`suspend a registration or change a classification not following a hearing." See 7 U.S.C.
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`§ 136n(a). Where a federal statute providing for judicial review of an agency's action
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`does not itself provide a standard of review, the "general standard of review of agency
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`action established in the Administrative Procedure Act ('APA')" applies. See Oregon
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`Natural Resources Council v. Allen, 476 F.3d 1031, 1036 (2007). Here, FIFRA does not
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`provide a standard of review for the denial of a request to immediately suspend a
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`pesticide product, and, consequently, the standard set forth in the APA applies. Under
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`the APA, a reviewing court shall "hold unlawful and set aside agency action, findings, and
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`conclusions found to be . . . arbitrary, capricious, an abuse of discretion, or otherwise not
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`in accordance with law." See 5 U.S.C. § 706(2). A plaintiff has the burden to show the
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`agency's decision was improper, and, "[a]bsent a showing of arbitrary action, [courts]
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`must assume that the [agency has] exercised [its] discretion appropriately." See Kleppe
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`v. Sierra Club, 427 U.S. 390, 412 (1976).
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`a. Imminent Hazard: Harm to Endangered/Threatened Species
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`As discussed above, the EPA has the authority to immediately suspend the
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`registration of a pesticide "to prevent an imminent hazard." See 7 U.S.C. § 136d(c)(1).
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`An "imminent hazard" is "a situation which exists when the continued use of a pesticide
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`during the time required for [a] cancellation proceeding [1] would be likely to result in
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`unreasonable adverse effects on the environment or [2] will involve unreasonable hazard
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`to the survival of a species declared endangered or threatened . . . pursuant to the
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`[ESA]." See 7 U.S.C. § 136(l).
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`Case 3:13-cv-01266-MMC Document 269 Filed 05/08/17 Page 8 of 39
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`Plaintiffs argue the denial of their request for an immediate suspension was
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`arbitrary and capricious for the reason that the Partial Response did not address the
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`second of the two alternative definitions of "imminent hazard," specifically, whether
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`continued use of clothianidin would "involve unreasonable hazard to the survival of a
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`species declared endangered or threatened." See id.
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`In their Petition, plaintiffs cited to studies, articles and other publications
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`addressing whether clothianidin causes harm to bees. Plaintiffs did not, however, cite to
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`a study or article, or otherwise reference any evidence, to show the continued use of
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`clothianidin would pose an unreasonable hazard to the survival of an endangered or
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`threatened species.6 Plaintiffs argue that the EPA nonetheless was required to address
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`the second of the two alternative definitions of imminent harm. As the Petition referenced
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`no evidence that could support such a finding, plaintiffs are arguing, in essence, that the
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`EPA was itself required to locate any evidence that might support a showing that
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`continued use of clothianidin would pose an unreasonable hazard to the survival of an
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`endangered or threatened species and then to determine whether such evidence would
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`suffice to support an immediate suspension.
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`The issue presented is one of burden. Neither FIFRA nor its implementing
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`regulations directly address the showing a party must make when it requests that the
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`EPA immediately suspend the registration of a pesticide product on account of an
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`asserted imminent hazard. As the EPA points out, however, the Code of Federal
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`Regulations does provide that, at a contested hearing on the issue of whether an order of
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`immediate suspension is proper, although "the ultimate burden of persuasion shall rest
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`with the proponent of the registration," the "proponent of suspension shall have the
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`burden of going forward to present an affirmative case for the suspension." See 40
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`6Although the Petition did state that "[n]umerous native Federally-listed insects
`may be directly impacted and non-insect species, such as insectivorous birds, may be
`indirectly affected [by clothianidin]" (see AR 44328), plaintiffs cited no evidence in support
`of such assertion.
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`Northern District of California
`United States District Court
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`Case 3:13-cv-01266-MMC Document 269 Filed 05/08/17 Page 9 of 39
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`C.F.R. § 164.121(g). The Court finds the principle underlying said regulation, specifically,
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`that the party who proposes a suspension bears the initial burden of coming forward with
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`evidence in support thereof, is properly applied to any procedure by which a party seeks
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`an immediate suspension.7
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`As plaintiffs' Petition did not identify any evidence that might show an imminent
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`hazard existed under the second of the two statutory definitions, plaintiffs did not meet
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`their initial burden of presenting an "affirmative case," see 40 C.F.R. § 164.121(g), for the
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`suspension. Under such circumstances, the Court finds plaintiffs have not met their
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`burden to show the EPA acted arbitrarily and capriciously when it did not address in the
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`Partial Response whether an immediate suspension was necessary to prevent an
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`unreasonable hazard to the survival of an endangered or threatened species.
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`b. Imminent Harm: Unreasonable Adverse Effects on Environment
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`Plaintiffs also argue that the EPA's failure to immediately suspend the petition,
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`under the "unreasonable adverse effects on the environment" definition of "imminent
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`harm," see 7 U.S.C. § 136(l), was arbitrary and capricious.
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`As noted above, the term "unreasonable adverse effects on the environment" is
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`defined as "any unreasonable risk to man or the environment, taking into account the
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`economic, social, and environmental costs and benefits of the use of any pesticide." See
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`7 U.S.C. § 136(bb). "[T]he statute thus requires the EPA to consider the benefits as well
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`as the risks of its use, including the economic consequences of suspension." See Love,
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`858 F.2d at 1357; see also id. at 1350, 1358, 1361-62 (holding, although evidence
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`supported EPA's finding that challenged pesticide "may cause serious health risks to
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`persons exposed to it, including sterility in men and birth defects in the unborn children of
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`7Although, as the Supreme Court has observed, "the ordinary rule, based on
`considerations of fairness, does not place the burden upon a litigant of establishing facts
`peculiarly within the knowledge of his adversary," see Campbell v. United States, 365
`U.S. 85, 96 (1961), plaintiffs did not assert during the administrative process and have
`not argued in the instant action that the facts pertinent to any effects clothianidin might
`have on endangered or threatened species are peculiarly within the knowledge of the
`EPA.
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`9
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`Northern District of California
`United States District Court
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`Case 3:13-cv-01266-MMC Document 269 Filed 05/08/17 Page 10 of 39
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`pregnant women," issuing order of immediate suspension was "arbitrary and capricious"
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`where EPA had not balanced risk of such harm against "economic impact of
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`suspension").
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`Here, plaintiffs argue, the denial was arbitrary and capricious for the asserted
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`reason that the "EPA failed to assess any alleged benefits from clothianidin's continued
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`use." (See Pls.' Mot. at 30:8.) As noted above, the EPA found plaintiffs' request for an
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`immediate suspension to be facially inadequate as it did not include "an explanation as to
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`how the harm identified outweighs the benefits to growers and the agricultural economy
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`from the use of the pesticide." (See AR 44423-24; see also AR 44429.) As the Petition
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`in fact included no such explanation, the issue presented is, again, one of burden.
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`In that regard, plaintiffs cite no authority to support their implicit argument that
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`where a party seeks an immediate suspension under the first of the two alternative
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`definitions of imminent harm, such party, to meet its initial burden, need do no more than
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`identify a harm,8 and, for the reasons discussed above, the Court finds a petitioner who
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`proposes an immediate suspension bears the initial burden of making an "affirmative
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`case" for such relief. See 40 C.F.R. § 164.121(g). As the Petition lacked any showing
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`that the asserted harm outweighed the pesticide's benefits, plaintiffs did not meet their
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`initial burden of presenting a case for an immediate suspension.9
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` Under such circumstances, the Court finds plaintiffs have not met their burden to
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`show the EPA, based on a finding of facial inadequacy, acted arbitrarily and capriciously
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`8Plaintiffs rely on two cases holding the EPA, before suspending a pesticide
`registration, must consider both "benefits" and "risks." See Love, 858 F.2d at 1357;
`Environmental Defense Fund, Inc. v. EPA, 465 F.2d 528 (D.C. Cir. 1972). The cited
`cases, however, do not address the burden placed on a party petitioning the EPA for a
`suspension. In one of the cases, the EPA issued the suspension order on its own
`initiative, see Love, 858 F.2d at 1350-51, and, in the other, the party petitioning for a
`suspension did offer evidence it contended showed the harm outweighed the benefits,
`see Environmental Defense Fund, 465 F.2d at 539 (noting petitioner's "submission" to
`EPA showing "alternative pest control mechanisms [were] available").
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`9Plaintiffs did not assert during the administrative process and have not argued in
`the instant action that facts pertinent to balancing the risks and benefits of clothianidin are
`peculiarly within the knowledge of the EPA.
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`10
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`Northern District of California
`United States District Court
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`Case 3:13-cv-01266-MMC Document 269 Filed 05/08/17 Page 11 of 39
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`in denying the request for an immediate suspension.10
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`c. Supplemental Filings
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`As noted above, the EPA did not consider, at the time it issued the Partial
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`Response, two supplemental filings plaintiffs had submitted to the EPA in support of the
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`Petition. Rather, as also noted, the EPA indicated it would consider those submissions
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`later in the administrative proceedings, specifically, after it had reviewed public comments
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`received in response to the Petition.
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`Under the APA, "due account shall be taken of the rule of prejudicial error," see 5
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`U.S.C. § 706; in other words, to be entitled to an order setting aside an agency decision
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`due to an error on the part of that agency, the plaintiff must show such error "was
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`harmful," see Shinseki v. Sanders, 556 U.S. 396, 406, 409-10 (2009) (holding § 706 is
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`codification of "harmless error rule"). Here, even assuming the EPA acted arbitrarily in
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`not considering plaintiffs' supplemental filings before it denied the request for an
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`immediate suspension, plaintiffs suffered no prejudice thereby, as none of the
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`supplemental filings addressed whether a suspension was necessary to prevent an
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`unreasonable hazard to the survival of a species declared endangered or threatened
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`under the ESA or whether the economic, social, and environmental benefits of
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`clothianidin were outweighed by the risks of its continued use.
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`Accordingly, plaintiffs have not shown they are entitled to relief based on the
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`EPA's determination not to review plaintiffs' supplemental filings prior to ruling on the
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`request for an immediate suspension.
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`B. Third and Fourth Claims
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`In the Third Claim, titled "EPA's Failure to Publish Notices of Pesticide
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`Applications for Clothianidin Products Violated FIFRA and the APA," plaintiffs allege the
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`10Plaintiffs also challenge as arbitrary and capricious the EPA's denial to the extent
`the EPA relied on the additional ground that plaintiffs had not shown a "substantial
`likelihood of serious imminent harm." (See AR 44424.) The Court has not considered
`herein such claimed error as, for the reasons stated above, plaintiffs have not shown the
`EPA acted arbitrarily and capriciously in finding the Petition was facially inadequate.
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`11
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`Case 3:13-cv-01266-MMC Document 269 Filed 05/08/17 Page 12 of 39
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`EPA registered seven products containing clothianidin without first providing in the
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`Federal Register notice of the applications to register such products, and that, when the
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`EPA approved said applications, it approved "new uses" for clothianidin, e.g., for use on
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`lawns. (See SAC ¶¶ 114-16.)11 In the similarly titled Fourth Claim, plaintiffs allege the
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`EPA registered nineteen products containing thiamethoxam without first providing in the
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`Federal Register notice of the applications to register those products, and, that when the
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`EPA approved said applications, it approved "new uses" for thiamethoxam, e.g., for use
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`on apples. (See SAC ¶¶ 121-23.)12 Plaintiffs argue that, in light of the alleged failures by
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`the EPA to provide notice to the public prior to registering the subject products, plaintiffs
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`10
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`are entitled to an order vacating the subject registrations. (See SAC ¶ 137.)
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`11
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`1. Applicable Statutory and Regulatory Framework
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`As noted, no pesticide may be distributed or sold, unless the pesticide has been
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`registered by the EPA. See 7 U.S.C. § 136a(a). To register a pesticide, an applicant
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`must file with the EPA an application that includes certain information, such as "the
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`complete formula of the pesticide" and "a request that the pesticide be classified for
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`general use or for restricted use, or for both." See 7 U.S.C. § 136a(c)(1). The EPA "shall
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`publish in the Federal Register . . . a notice of each application for registration of any
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`pesticide if it contains any new ingredient," see 7 U.S.C § 136a(c)(4), or, alternatively, "if
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`it would entail a changed use pattern," see id., which alternative pertains when the
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`application "proposes a new use" for the pesticide, see 40 C.F.R. § 152.102. When it
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`publishes such a notice in the Federal Register, the EPA must "provide for a period of 30
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`days in which any Federal agency or any other interested person may comment," see 7
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`11Although the SAC alleges the EPA, without notice to the public, approved twenty-
`four applications that sought new uses for clothianidin (see SAC ¶¶ 114-16), plaintiffs
`clarify in their motion for summary judgment that only seven product registrations are
`challenged by the Third Claim (see Wu Decl., filed April 14, 2016, Ex. V).
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`12Although the SAC alleges the EPA, without notice to the public, approved forty-
`one applications that sought new uses for thiamethoxam (see SAC ¶¶ 121-23), plaintiffs
`clarify in their motion for summary judgment that only nineteen product registrations are
`challenged by the Fourth Claim (see Wu Decl., filed April 14, 2016, Ex. V).
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`12
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`Northern District of California
`United States District Court
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`Case 3:13-cv-01266-MMC Document 269 Filed 05/08/17 Page 13 of 39
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`U.S.C. § 136a(c)(4), and, in the event the EPA subsequently grants the application, it
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`must "issue in the Federal Register a notice of issuance" and, inter alia, must "respond
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`[therein] to comments received on the notice of application," see 40 C.F.R. § 152.102.
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`2. Standing
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`At the outset, the EPA challenges plaintiffs' standing to bring the Third and Fourth
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`Claims.
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`"To satisfy Article III's standing requirements, a plaintiff must show (1) it has
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`suffered an injury in fact that is (a) concrete and particularized and (b) actual or imminent,
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`not conjectural or hypothetical; (2) the injury is fairly traceable to the challenged action of
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`the defendant; and (3) it is likely, as opposed to merely speculative, that the injury will be
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`redressed by a favorable decision." Citizens for Better Forestry v. U.S. Dep't of
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`Agriculture, 341 F.3d 961, 969 (9th Cir. 2003) (internal q