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Case: 22-70118, 09/01/2022, ID: 12531716, DktEntry: 16-1, Page 1 of 35
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`Case No. 22-70118
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`UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`
`CENTER FOR FOOD SAFETY,
`Petitioners,
`
`v.
`
`UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, et al.,
`Respondents,
`
`and
`
`SYNGENTA CROP PROTECTION, LLC,
`Respondent-Intervenor.
`
`On Petition for Review of an Order of the
`United States Environmental Protection Agency
`
`PETITIONERS’ MOTION FOR SUMMARY VACATUR
`
`
`CENTER FOR FOOD SAFETY
`Amy van Saun
`2009 NE Alberta St., Suite 207
`Portland, OR 97211
`T: (971) 271-7372
`avansaun@centerforfoodsafety.org
`
`Sylvia Shih-Yau Wu
`Meredith Stevenson
`303 Sacramento Street, 2F
`San Francisco, CA 94111
`(415) 826-2770
`swu@centerforfoodsafety.org
`mstevenson@centerforfoodsafety.org
`
`Counsel for Petitioners
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`
`
`
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`

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`Case: 22-70118, 09/01/2022, ID: 12531716, DktEntry: 16-1, Page 2 of 35
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`TABLE OF CONTENTS
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`INTRODUCTION AND SUMMARY OF ARGUMENT .................. 1
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`FACTUAL BACKGROUND .............................................................. 3
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`PROCEDURAL HISTORY ................................................................ 5
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`JURISDICTION ................................................................................ 8
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`STANDARD OF REVIEW .............................................................. 11
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`ARGUMENT .................................................................................... 13
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`I.
`
`II.
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`EPA’s Endangered Species Act Violation
`Is Clear Error. ............................................................... 13
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`EPA’s Lack of Substantial Evidence Under
`FIFRA Is Clear Error. ................................................... 18
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`III. Vacatur Is the Proper Remedy. .................................... 23
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`CONCLUSION ................................................................................ 27
`
`CERTIFICATE OF COMPLIANCE ............................................... 28
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`CERTIFICATE OF SERVICE ........................................................ 29
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`ii
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`TABLE OF AUTHORITIES
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` Page(s)
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`Federal Cases
`All. for the Wild Rockies v. U.S. Forest Serv.,
`907 F.3d 1105 (9th Cir. 2018) ........................................................ 23, 24
`Coal. to Protect Puget Sound Habitat v. U.S. Army Corps. of Eng’rs,
`466 F. Supp. 3d 1217 (W.D. Wash. 2020) ........................................... 25
`Conner v. Burford,
`848 F.2d 1441 (9th Cir. 1988) .............................................................. 12
`Ctr. for Food Safety v. Vilsack,
`734 F. Supp. 2d 948 (N.D. Cal. 2010) .................................................. 25
`Defs. of Wildlife v. Adm’r, EPA,
`882 F.2d 1294 (8th Cir. 1989) .............................................................. 16
`Ellis v. Housenger,
`252 F. Supp. 3d 800 (N.D. Cal. 2017) .................................................. 16
`Farmworker Ass’n of Fla. v. EPA,
`No. 21-1079, 2021 U.S. App. LEXIS 16882 (D.C. Cir. June
`7, 2021) ....................................................................................... 2, 13, 15
`Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc.,
`528 U.S. 167 (2000) ............................................................................ 8, 9
`Humane Soc’y of the United States v. Locke,
`626 F.3d 1040 (9th Cir. 2010) .............................................................. 23
`Idaho Farm Bureau Fed’n v. Babbitt,
`58 F.3d 1392 (9th Cir. 1995) ................................................................ 23
`Karuk Tribe of Cal. v. U.S. Forest Serv.,
`681 F.3d 1006 (9th Cir. 2012) .................................................. 13, 14, 16
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`iii
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`Federal Cases (Cont’d)
`Lane Cty. Audubon Soc’y v. Jamison,
`958 F.2d 290 (9th Cir. 1992) ................................................................ 16
`Mass. v. EPA,
`549 U.S. 497 (2007) .............................................................................. 11
`Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co.,
`463 U.S. 29 (1983) ................................................................................ 12
`Nat. Res. Def. Council, Inc. v. EPA,
`38 F.4th 34 (9th Cir. 2022) .......................................................... passim
`Nat. Res. Def. Council, Inc. v. FDA,
`710 F.3d 71 (2d Cir. 2013) ................................................................... 10
`Nat. Res. Def. Council v. EPA,
`No. 20-70787 (9th Cir. filed Aug. 1, 2022) .................................... 26, 27
`Nat’l Family Farm Coal. v. EPA,
`960 F.3d 1120 (9th Cir. 2020) ................................................ 3, 8, 18, 24
`Nat’l Parks Conservation Ass’n v. Jewell,
`62 F. Supp. 3d 7 (D.D.C. 2014) ............................................................ 24
`Pollinator Stewardship Council v. EPA,
`806 F.3d 520 (9th Cir. 2015) ........................................................ passim
`Salmon Spawning & Recovery All. v. Gutierrez,
`545 F.3d 1220 (9th Cir. 2008) .............................................................. 11
`Tucson Herpetological Soc’y v. Salazar,
`566 F.3d 870 (9th Cir. 2009) ................................................................ 22
`United States v. Hooton,
`693 F.2d 857 (9th Cir. 1982) .................................................... 11, 13, 18
`W. States Petroleum Ass’n v. EPA,
`87 F.3d 280 (9th Cir. 1996) .................................................................. 22
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`Page(s)
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`Federal Cases (Cont’d)
`W. Watersheds Project v. Kraayenbrink,
`632 F.3d 472 (9th Cir. 2011) .......................................................... 13, 24
`Wash. Toxics Coal. v. EPA,
`413 F.3d 1024 (9th Cir. 2005) .............................................................. 16
`Williams v. Hampton,
`No. 19-56197, 2020 U.S. App. LEXIS 10473 (9th Cir. Apr.
`2, 2020) ..................................................................................... 11, 13, 18
`Federal Statutes
`5 U.S.C. § 706(2)(A) ............................................................................ 12, 13
`7 U.S.C. § 136a(c)(2)(B) ............................................................................ 19
`7 U.S.C. § 136h(d)(1) ............................................................................ 2, 20
`7 U.S.C. § 136n(b) ........................................................................... 8, 11, 13
`16 U.S.C. § 1536(a) ................................................................................... 14
`16 U.S.C. § 1536(a)(2) ......................................................................... 13, 14
`FIFRA ................................................................................................ passim
`Rules
`9th Cir. R. 3-6(a) ......................................................................................... 1
`9th Cir. R. 3-6(a)(1) ................................................................................... 11
`9th Cir. R. 27-1 ........................................................................................... 1
`9th Cir. R. 27-1(2) ....................................................................................... 1
`Fed. R. App. P. 27 ....................................................................................... 1
`Fed. R. App. P. 32.1 .................................................................................... 2
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`Page(s)
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`v
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`Regulations
`40 C.F.R. § 23.6 ........................................................................................... 8
`40 C.F.R. § 152.112(b)-(c) ......................................................................... 22
`40 C.F.R. § 155.40(a)(1) ............................................................................ 19
`40 C.F.R. § 158.130(d)(6) .......................................................................... 20
`40 C.F.R. § 158.630(d), (e) ........................................................................ 21
`40 C.F.R. § 159.179(a) .............................................................................. 20
`50 C.F.R. § 402.01(b) ................................................................................ 14
`50 C.F.R. §§ 402.13-.14 ............................................................................. 14
`50 C.F.R. § 402.14(a) .......................................................................... 13, 14
`Other Authorities
`EPA, Overview of the Ecological Risk Assessment Process 46-
`47 (Jan. 2004),
`https://www.epa.gov/sites/default/files/2014-
`11/documents/ecorisk-overview.pdf ..................................................... 17
`Pesticide Registration Review; Proposed Interim Decisions for
`Several Pesticides; Notice of Availability, 86 Fed. Reg.
`41,838 (Aug. 3, 2021) ............................................................................. 5
`
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`INTRODUCTION AND SUMMARY OF ARGUMENT
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`Petitioner Center for Food Safety (CFS) hereby moves this Court
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`to summarily reverse and vacate the Respondent Environmental
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`Protection Agency’s (EPA or Respondent) interim registration of
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`difenoconazole, an approval which violates both the Endangered Species
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`Act (ESA) and the Federal Insecticide, Fungicide, and Rodenticide Act
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`(FIFRA).1 9th Cir. R. 3-6(a); Fed. R. App. P. 27; 9th Cir. R. 27-1.2
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`Pursuant to the ESA, Respondent’s flouting of its consultation duties—
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`for a fungicide that EPA knows causes harm to federally protected
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`endangered species—is clear error warranting summary vacatur. And
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`under FIFRA, EPA’s decision to issue difenoconazole’s interim
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`registration without critical studies on the fungicide’s potential harm to
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`public health also warrants summary vacatur.
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`
`
`1 Difenoconazole: Interim Registration Review Decision, Case Number
`7014, EPA-HQ-OPP-2015-0401 (Interim Registration Review Decision),
`Attachment 1.
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` 2
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` Respondents reserve their position and Respondent-Intervenor
`opposes this motion. See 9th Cir. R. 27-1(2).
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`1
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`The D.C. Circuit recently granted summary vacatur in an
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`analogous situation, for EPA’s failure to comply with the ESA before
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`registering the pesticide aldicarb, based on the “seriousness of the
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`admitted error and the error’s direct impacts on the merits of the EPA’s
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`registration decision.” Farmworker Ass’n of Fla. v. EPA, No. 21-1079,
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`2021 U.S. App. LEXIS 16882 (D.C. Cir. June 7, 2021); see Fed. R. App.
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`P. 32.1. The same is warranted here, for at least two reasons. First,
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`EPA committed clear error in issuing the difenoconazole decision
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`without ESA compliance. Nat. Res. Def. Council, Inc. v. EPA, 38 F.4th
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`34, 59 (9th Cir. 2022) (holding that interim registration review decisions
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`like this one trigger ESA duties). And second, EPA issued its decision
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`without critical studies that the agency itself requested over twenty
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`years ago, studies on a topic (metabolism) which FIFRA itself requires,
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`7 U.S.C. § 136h(d)(1) (requiring EPA to support registrations with, inter
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`alia, studies on “persistence, translocation and fate in the environment,
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`and metabolism.”). See Pollinator Stewardship Council v. EPA, 806 F.3d
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`520, 537 (9th Cir. 2015) (holding EPA pesticide approval lacking
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`substantial evidence and vacating under FIFRA for lack of key studies).
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`For either or both reasons, this Court should summarily vacate the
`2
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`decision and remaexnd. Nat’l Family Farm Coal. v. EPA, 960 F.3d 1120,
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`
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`1144–45 (9th Cir. 2020).
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`FACTUAL BACKGROUND
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`Difenoconazole is a broad-spectrum systematic fungicide.3
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`Fungicides are a subclass of pesticides that target fungal pests like
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`mold and mildew. Attach 1 at 24. Systemic fungicides like
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`difenoconazole are absorbed and distributed throughout the plant’s
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`tissue, flowers, and fruits after application, increasing persistence of the
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`fungicide in the plant and its new growth. Id.
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`Like all pesticides, fungicides like difenoconazole are toxic
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`substances intentionally released or sprayed to kill pests, but that also
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`kill and harm “non-target” plants and animals. As EPA recognized,
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`difenoconazole potentially threatens a wide variety of species, from
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`“mammals, birds, terrestrial invertebrates, freshwater and
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`estuarine/marine fish, and aquatic invertebrates.” Id. at 25.
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`3 EPA, Difenoconazole: Draft Ecological Risk Assessment for
`Registration Review 5 (Sept. 16, 2020), Attachment 2.
`3
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`Despite its potential harm to species and human health, over the
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`years, EPA has approved difenoconazole use across a wide variety of
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`landscapes. Initially approved as a seed treatment4 on commodity crops,
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`today the systemic fungicide is approved for many nationwide uses
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`including: seed treatment on wheat and other cereal grains, cotton, and
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`potatoes; direct spraying on major crops and commodities, including
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`soybeans, sugar beets, various fruits and vegetables, tree nuts; and
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`spraying on golf course turf grass and ornamental plants.
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`Difenoconazole’s use has increased dramatically since 2008, when EPA
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`first approved direct spraying on soybeans, roughly 20-fold from 2008 to
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`2017 (from 25,000 to 500,000 lbs. per year), and continues to increase.5
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`See id. at 12.
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`4 Seed treatments involve coating crop seeds with systemic pesticides,
`which are absorbed into the plants’ circulatory system as the plant
`grows. Attach. 1 at 25.
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` 5
`
` Center for Food Safety, Comments on Proposed Interim Registration
`Decision for Difenoconazole 2, EPA-HQ-OPP-2015-0401, Attachment 4.
`4
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`PROCEDURAL HISTORY
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`EPA published the proposed interim registration review decision
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`for public comment on August 3, 2021.6 Petitioner submitted comments.
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`See Attach. 4. Among other critiques, Petitioner underscored EPA’s
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`failure to comply with the ESA and consult on difenoconazole with the
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`expert wildlife agencies and obtain the critical studies on
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`difenoconazole’s risks to public health. Id.
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`In the ecological risk assessment accompanying the proposed
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`interim registration, EPA acknowledged that difenoconazole application
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`exceeds EPA’s own acute and/or chronic “levels of concern” (LOCs) for
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`numerous plants and animals, including fish, estuarine/marine
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`invertebrates, aquatic invertebrates, honeybees, aquatic plants, and
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`birds. Attach. 2 at 7, 9-13. Exposure occurs through runoff and spray
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`drift to water and sediment, id. at 43-44, with difenoconazole’s noted
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`
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`6 Difenoconazole: Proposed Interim Registration Review Decision, Case
`Number 7014, EPA-HQ-OPP-2015-0401-0049 (“Proposed Interim
`Registration Review Decision”); Pesticide Registration Review; Proposed
`Interim Decisions for Several Pesticides; Notice of Availability, 86 Fed.
`Reg. 41,838 (Aug. 3, 2021).
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`5
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`persistence increasing its accumulation in soil and aquatic
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`environments. Id. at 8. Indeed, EPA identified chronic risk LOC
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`exceedances for birds for up to 150 days after application in some
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`scenarios, and after 56 days for mammals. Id. at 11.
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`In spite of these acknowledgments of harm to numerous categories
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`of species throughout its risk assessment, EPA at the same time readily
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`admits it has not complied with the ESA. Attach 1 at 4 (“The Agency
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`has not yet fully evaluated difenoconazole’s risks to federally listed
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`species.”); Attach. 2 at 13 (“Federally listed threatened and endangered
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`species are not evaluated in the document.”). Instead, EPA promises
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`only to consult before its final registration decision—an entirely
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`different federal action—and offered no timeline or work plan for when
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`that may happen. Attach. 1 at 34-35.
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`EPA also issued its proposed interim registration without the
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`critical information it requested twenty-two years ago on
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`difenoconazole’s potential adverse public health effects. Specifically, in
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`2000, EPA demanded pesticide registrants provide numerous studies to
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`ensure that use of the fungicides in this class do not impair developing
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`infants’ brains and nervous systems, cause cancer, or disrupt hormonal
`6
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`systems.7 Then, EPA halted any further registrations of fungicides in
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`the triazole class—to which difenoconazole belongs—over twenty years
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`ago.8 Attach. 1 at 9. Yet the proposed registration still contains the
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`same glaring data gaps on difenoconazole’s impacts on reproductive and
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`developmental health.
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`EPA subsequently issued its final interim registration decision
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`and finalized its draft risk assessments on March 31, 2022. Attach. 1 at
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`4. Regarding its ESA duties, EPA stated only that it would not undergo
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`consultation until its separate final registration review decision, and
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`still offered no timeline for that decision, in spite approving
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`difenoconazole’s continued use. Id. at 34-35. And under FIFRA, the
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`human health studies EPA mandated more than twenty years ago still
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`remained lacking, but EPA nonetheless issued the interim registration
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`
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`7 See EPA, 1,2,4-Triazole, Triazole Alanine, Triazole Acetic Acid:
`Human Health Aggregate Risk Assessment in Support of Reregistration
`and Registration Actions for Triazole-derivative Fungicide Compounds 6
`(Feb. 7, 2006), Attachment 3.
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`7
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` 8
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` Attach. 3, at 7.
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`by substituting a “conservative” uncertainty factor for actual studies.
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`Id. at 9.
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`Petitioner timely filed this petition for review. ECF No. 1-6 (June
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`13, 2022). Registrant Syngenta intervened. ECF No. 9 (July 13, 2022);
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`ECF No. 15 (July 27, 2022). The parties participated in this Court’s
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`required mediation process but their discussions failed to progress.
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`Petitioner now files this motion seeking summary vacatur of the
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`challenged decision in light of EPA’s admitted ESA violation and
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`continued lack of substantial evidence to support the interim
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`registration approval of difenoconazole under FIFRA.
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`JURISDICTION
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`This Court has jurisdiction under FIFRA, which provides for
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`direct review in the courts of appeals of “any order issued by [EPA]
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`following a public hearing.” 7 U.S.C. § 136n(b); Nat’l Family Farm Coal.
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`v. EPA, 960 F.3d at 1131. EPA provided a “public hearing” by holding
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`notice and comment. Id. Petitioner submitted comments and timely
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`filed this petition for review. 7 U.S.C. § 136n(b); 40 C.F.R. § 23.6.
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`Petitioner has standing. Friends of the Earth, Inc. v. Laidlaw
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`Envtl. Servs. (TOC), Inc., 528 U.S. 167, 180-81 (2000). The
`8
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`environmental interests at stake are germane to Petitioner’s
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`organizational mission, and this Court can redress the injuries to
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`Petitioner’s members. 9 Id. The procedural nature of Petitioner’s
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`injuries (Section 7 consultation sets a strict procedure to ensure
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`compliance with ESA’s substantive commands), calls for a relaxed
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`causation and redressability standard. Nat. Res. Def. Council, 38 F.4th
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`at 54. Namely, Petitioner must only show a “reasonable probability of
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`the challenged action’s threat to [Petitioner’s] concrete interest,” id.
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`(citations omitted), and that “the agency decision ‘could be influenced’
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`by the procedures at issue.” Id. at 56 (quoting Hall v. Norton, 266 F.3d
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`969, 977 (9th Cir. 2001).
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`This low bar is easily met here: EPA’s failure to fulfill its ESA
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`obligations injures Petitioner’s members who have environmental,
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`professional, recreational, and aesthetic interests in seeing, studying,
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`and protecting dozens of ESA-protected species—including the
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`smalltooth sawfish, whooping crane, and Everglade snail kite—all of
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`
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`9 See Attach. 5, Decl. Loda; Attach. 6, Decl. Naegele; Attach. 7, Decl.
`Schudda; Attach. 8, Decl. Wu.
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`9
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`which difenoconazole harms. Crops permitted for difenoconazole
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`spraying and seed treatment overlap with the habitats and range of
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`many ESA-protected species for which difenoconazole exposure exceeds
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`EPA’s levels of concern. Attach. 2 at 7, 9-13. See Attach. 9, Sinclair Decl.
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`(mapping overlap of difenoconazole-approved crop uses with critical
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`habitat for six ESA-protected species). Proper ESA compliance before
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`issuance may have resulted in protective measures included in this
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`decision for species to protect members’ interests.
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`And Petitioner’s members’ exposure to potentially harmful
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`difenoconazole residues also meets this standard. For injuries from
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`exposure, Petitioner only needs to show “a credible threat of harm” due
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`to exposure to “potentially harmful” difenoconazole residues, Nat. Res.
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`Def. Council, Inc. v. FDA, 710 F.3d 71, 81 (2d Cir. 2013), as amended
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`(Mar. 21, 2013) (quoting Baur v. Veneman, 352 F.3d 625, 641 (2d Cir.
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`2003) (“[T]he relevant ‘injury’ for standing purposes may be exposure to
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`a sufficiently serious risk of medical harm—not the anticipated medical
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`harm itself.”). Petitioner’s members regularly consume foods with
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`potentially harmful difenoconazole residues, which EPA might have
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`addressed had it properly collected and considered the public health
`10
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`Case: 22-70118, 09/01/2022, ID: 12531716, DktEntry: 16-1, Page 17 of 35
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`
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`studies. Salmon Spawning & Recovery All. v. Gutierrez, 545 F.3d 1220,
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`
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`1226-27 (9th Cir. 2008) (Petitioner “need[s] to show only that the relief
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`requested—that the agency follow the correct procedures—may
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`influence the agency’s ultimate decision of whether to take or refrain
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`from taking a certain action.”); Mass. v. EPA, 549 U.S. 497, 518 (2007)
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`(“[A] litigant has standing if there is some possibility that the requested
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`relief will prompt the injury-causing party to reconsider the decision
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`that allegedly harmed the litigant.”).
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`STANDARD OF REVIEW
`
`Summary reversal and vacatur is warranted when this Court
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`concludes the respondent committed “clear error.” 9th Cir. R. 3-6(a)(1);
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`Williams v. Hampton, No. 19-56197, 2020 U.S. App. LEXIS 10473, at *1
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`(9th Cir. Apr. 2, 2020). Where, as here, the agency decision is “obviously
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`controlled by precedent,” then “summary disposition is of obvious
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`benefit to all concerned,” and should be issued. United States v. Hooton,
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`693 F.2d 857, 858 (9th Cir. 1982).
`
`Under FIFRA, this Court may affirm EPA’s difenoconazole’s
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`interim registration approval only if it is “supported by substantial
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`evidence when considered on the record as a whole.” 7 U.S.C. § 136n(b).
`11
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`The FIFRA substantial evidence standard “affords an agency less
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`
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`deference than the arbitrary and capricious standard.” Pollinator
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`Stewardship, 806 F.3d at 533 (N.R. Smith, J., concurring) (citing
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`Universal Camera Corp. v. NLRB, 340 U.S. 474, 477 (1951); Union Oil
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`Co. v. Fed. Power Com., 542 F.2d 1036, 1040-41 (9th Cir. 1976)).
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`Therefore, if EPA’s decision is arbitrary and capricious, it cannot be
`
`supported by substantial evidence. To avoid being arbitrary and
`
`capricious, EPA “must examine the relevant data and articulate a
`
`satisfactory explanation for its action including a rational connection
`
`between the facts found and the choice made.” Motor Vehicle Mfrs. Ass’n
`
`v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983) (internal
`
`citations and quotations omitted).
`
`Similarly, EPA violated the ESA if its failure to consult the expert
`
`wildlife agencies was arbitrary, capricious, an abuse of discretion, or
`
`otherwise not in compliance with law. 5 U.S.C. § 706(2)(A); see Conner
`
`v. Burford, 848 F.2d 1441, 1453 (9th Cir. 1988). Agency actions subject
`
`to mandatory consultation include interim registration review decisions
`
`such as this one. Nat. Res. Def. Council, 38 F.4th at 59. The ESA
`
`requires that federal agencies consult the expert wildlife agencies before
`12
`
`
`
`

`

`Case: 22-70118, 09/01/2022, ID: 12531716, DktEntry: 16-1, Page 19 of 35
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`
`
`taking any action that “may affect” any protected species or critical
`
`
`
`habitat, 50 C.F.R. § 402.14(a); see 16 U.S.C. § 1536(a)(2), and to do so
`
`“at the earliest possible time.” 50 C.F.R. § 402.14(a); Karuk Tribe of Cal.
`
`v. U.S. Forest Serv., 681 F.3d 1006, 1020 (9th Cir. 2012).
`
`If the Court holds EPA unlawfully issued the interim registration
`
`of difenoconazole, it should “set aside,” or vacate it. 7 U.S.C. § 136n(b); 5
`
`U.S.C. § 706(2)(A); Pollinator Stewardship, 806 F.3d at 532-33; see, e.g.,
`
`Farmworker Ass’n of Fla., 2021 U.S. App. LEXIS 16882.
`
`ARGUMENT
`
`I.
`
`EPA’s Endangered Species Act Violation Is Clear Error.
`EPA’s violation of its ESA Section 7 consultation duties for
`
`difenoconazole is “clear error” that is “obviously controlled by
`
`precedent,” and thus warrants summary reversal. Williams, 2020 U.S.
`
`App. LEXIS at *1; Hooton, 693 F.2d at 858.
`
`Section 7(a)(2) is the “heart” of the ESA. W. Watersheds Project v.
`
`Kraayenbrink, 632 F.3d 472, 495 (9th Cir. 2011). It mandates that
`
`“[e]ach federal agency” “insure” that its action—here, EPA completing
`
`its interim registration review—is not likely to either jeopardize any
`
`endangered species or adversely modify any designated “critical”
`
`
`
`13
`
`

`

`Case: 22-70118, 09/01/2022, ID: 12531716, DktEntry: 16-1, Page 20 of 35
`
`
`
`habitat, by consulting with the U.S. Fish and Wildlife Service and
`
`
`
`National Marine Fisheries Service (the Expert Agencies). 16 U.S.C.
`
`§ 1536(a)(2); 50 C.F.R. § 402.01(b). If an action agency makes a “may
`
`affect” determination, it must then insure, through consultation with
`
`the Expert Agencies, that the action is not likely to cause jeopardy or
`
`adversely modify designated critical habitat. 16 U.S.C. § 1536(a); 50
`
`C.F.R. §§ 402.13-.14. The ESA commands that agencies complete this
`
`review and make this determination “at the earliest possible time.” 50
`
`C.F.R. § 402.14(a); Karuk Tribe, 681 F.3d at 1020.
`
`Just two months ago, this Court made plain that EPA cannot flout
`
`its ESA duties as it did here when making an interim registration
`
`review decision. Rather as this Court held, interim registration review
`
`falls squarely within the purview of “agency action” and triggers
`
`mandatory consultation. Nat. Res. Def. Council, 38 F.4th at 58. In
`
`Natural Resources Defense Council, regarding the interim registration
`
`of the pesticide glyphosate, this Court explained that interim
`
`registrations are cognizable “agency actions” triggering consultation
`
`because 1) they are “affirmative” actions, and 2) they delineate the way
`
`in which producers may continue pesticide use consistent with FIFRA.
`14
`
`
`
`

`

`Case: 22-70118, 09/01/2022, ID: 12531716, DktEntry: 16-1, Page 21 of 35
`
`
`
`Id. at 58-59. Through the interim registration, EPA has discretionary
`
`
`
`control to benefit protected species through mitigation measures or
`
`otherwise, like deciding which factors to consider in the ecological risk
`
`assessment. Id.
`
`The present case is no different than the glyphosate interim
`
`registration. In both instances, EPA issued a so-called “interim”
`
`registration that actually finalized the agency’s ecological and human
`
`health risk assessments, yet deferred ESA consultation until a final
`
`registration review decision at some later, undetermined time. See id. at
`
`43. As this Court found in Natural Resources Defense Council, EPA
`
`violated the ESA by failing to comply with the ESA consultation
`
`requirements before issuing the interim registration. Id. at 59.
`
`In fact, EPA’s violation of the ESA here is even more egregious
`
`than in Natural Resources Defense Council, because unlike in that case
`
`here EPA has not even started a draft ESA Biological Evaluation to
`
`make the required effects determination. Accordingly, pursuant to
`
`Natural Resources Defense Council, the ESA and its implementing
`
`regulations’ plain language, as well as numerous other ESA precedent,
`
`EPA violated the ESA. E.g., Farmworker Ass’n of Fla., 2021 U.S. App.
`15
`
`
`
`

`

`Case: 22-70118, 09/01/2022, ID: 12531716, DktEntry: 16-1, Page 22 of 35
`
`
`
`LEXIS 16882; Wash. Toxics Coal. v. EPA, 413 F.3d 1024, 1029 (9th Cir.
`
`
`
`2005) (failure to consult for fifty-four pesticides); Ellis v. Housenger, 252
`
`F. Supp. 3d 800, 820 (N.D. Cal. 2017) (failure to consult for dozens of
`
`pollinator-harming pesticides); Lane Cty. Audubon Soc’y v. Jamison,
`
`958 F.2d 290, 294 (9th Cir. 1992) (interim management strategy
`
`designed to be implemented immediately constitutes agency action
`
`triggering consultation); Defs. of Wildlife v. Adm’r, EPA, 882 F.2d 1294,
`
`1301 (8th Cir. 1989) (strychnine registration violated ESA).
`
`And had EPA complied with the ESA and completed a Biological
`
`Evaluation, it almost certainly would have triggered formal ESA
`
`consultation. The “may affect” threshold triggering consultation is
`
`extremely low: “actions that have any chance of affecting listed species
`
`or critical habitat … require at least some consultation under the ESA.”
`
`Karuk Tribe, 681 F.3d at 1027 (emphasis added); id. (“Any possible
`
`effect, whether beneficial, benign, adverse or of an undetermined
`
`character, triggers the requirement.”) (citation and quotation omitted).
`
`Here, EPA admits in its ecological risk assessment that difenoconazole,
`
`approved for dozens of crops across the country, exceeds its own toxicity
`
`level of concern for exposures when used as approved for wide
`16
`
`
`
`

`

`Case: 22-70118, 09/01/2022, ID: 12531716, DktEntry: 16-1, Page 23 of 35
`
`
`
`categories of species, including fish, estuarine/marine and aquatic
`
`
`
`invertebrates, honeybees, aquatic plants, and birds. Attach 2 at 7, 9-13.
`
`EPA found the level of concern exceeded for non-federally protected
`
`species, meaning that under EPA’s own risk assessment framework, the
`
`same difenoconazole uses would also potentially harm federally
`
`protected species belonging to the same categories.10
`
`And there are hundreds of endangered species that fall into these
`
`broad species categories for which EPA acknowledges risk. To give just
`
`a few examples, extensive difenoconazole use: in California’s Central
`
`Valley overlaps with California condor and conservancy fairy shrimp
`
`habitat; in the Midwest with whooping crane habitat; and in Florida
`
`with smalltooth sawfish and the Everglade snail kite habitat. See
`
`Attach. 9, Decl. Sinclair (and exhibits). But EPA admits it failed to do
`
`any analysis of these risks to ESA-protected birds, fish, and other
`
`species. Attach 1 at 3.
`
`
`
`10 See EPA, Overview of the Ecological Risk Assessment Process 46-47
`(Jan. 2004), https://www.epa.gov/sites/default/files/2014-
`11/documents/ecorisk-overview.pdf (explaining that the level of
`concerns are set at lower thresholds for endangered species compared to
`their non-federally listed counterparts).
`17
`
`
`
`

`

`Case: 22-70118, 09/01/2022, ID: 12531716, DktEntry: 16-1, Page 24 of 35
`
`
`
`Because EPA’s well-established ESA violation is “clear error” that
`
`
`
`is “obviously controlled by precedent,” Williams, 2020 U.S. App. LEXIS
`
`at *1; Hooton, 693 F.2d at 858, this Court should grant summary
`
`reversal.
`
`II. EPA’s Lack of Substantial Evidence Under FIFRA Is Clear
`Error.
`The ESA violation alone is more than sufficient ground on which
`
`to vacate the interim registration. However and additionally, EPA’s
`
`failure to obtain the requisite studies on public health it mandated
`
`more than two decades ago also constitutes “clear error … obviously
`
`controlled by precedent.” Williams, 2020 U.S. App. LEXIS at *1;
`
`Hooton, 693 F.2d at 858. Without these studies, EPA cannot support its
`
`interim registration decision with substantial evidence as FIFRA
`
`requires, since the need for the health data prompted EPA to issue a
`
`moratorium on further registrations in 2000. Attach. 3; see Nat’l Family
`
`Far

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