`
`ORAL ARGUMENT NOT YET SCHEDULED
`
`Case Nos. 19-72109, 19-72280
`
`
`UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`
`CENTER FOR FOOD SAFETY, et al.,
`Petitioners,
`v.
`JANE NISHIDA, et al.,
`Respondents,
`and
`DOW AGROSCIENCES LLC,
`Respondent-Intervenor.
`
`POLLINATOR STEWARDSHIP COUNCIL, et al.,
`Petitioners,
`v.
`JANE NISHIDA, et al.,
`Respondents,
`and
`DOW AGROSCIENCES LLC,
`Intervenor.
`
`ON PETITION FOR REVIEW FROM THE UNITED STATES
`ENVIRONMENTAL PROTECTION AGENCY
`
`CENTER FOR FOOD SAFETY ET AL. PETITIONERS’ OPENING BRIEF
`
`
`CENTER FOR FOOD SAFETY
`George A. Kimbrell
`Sylvia Shih-Yau Wu
`Amy van Saun
`2009 NE Alberta St., Suite 207
`Portland, OR 97211
`T: (971) 271-7372
`gkimbrell@centerforfoodsafety.org
`swu@centerforfoodsafety.org
`avansaun@centerforfoodsafety.org
`
`
`
`
`
`CENTER FOR BIOLOGICAL
`DIVERSITY
`Stephanie M. Parent
`PO Box 11374
`Portland, OR 97211
`T: (971) 717-6404
`SParent@biologicaldiversity.org
`
`Counsel for Petitioners Center for Food Safety,
`et al.
`
`
`
`Case: 19-72109, 02/16/2021, ID: 12005376, DktEntry: 71, Page 2 of 196
`
`TABLE OF CONTENTS
`
`TABLE OF CONTENTS .............................................................................................. ii
`
`TABLE OF AUTHORITIES....................................................................................... iiv
`
`GLOSSARY OF ABBREVIATIONS........................................................................... xi
`
`INTRODUCTION ........................................................................................................ 1
`
`JURISDICTIONAL STATEMENT .............................................................................. 3
`
`ISSUES PRESENTED ................................................................................................... 5
`
`STATEMENT OF THE CASE ..................................................................................... 6
`
`I.
`
`II.
`
`Sulfoxaflor ................................................................................................. 6
`
`EPA’s Legal Duties in Registering Pesticides. .......................................... 7
`
`A.
`
`B.
`
`Federal Insecticide, Fungicide, and Rodenticide Act. .................. 7
`
`Endangered Species Act .............................................................. 10
`
`III.
`
`EPA’s Registration History of Sulfoxaflor. ............................................ 14
`
`A. The 2013 Initial Registration. ..................................................... 14
`
`B.
`
`Pollinator I Litigation. ................................................................... 18
`
`C. Dow’s 2014 Sulfoxaflor Use Application. .................................. 19
`
`D. The 2016 Registration. ................................................................ 20
`
`E.
`
`The Challenged 2019 Registration. ............................................ 21
`
`SUMMARY OF ARGUMENT S.................................................................................24
`
`STANDARD OF REVIEW ......................................................................................... 26
`
`ARGUMENT ............................................................................................................... 28
`
`I.
`
`EPA Violated the ESA. ........................................................................... 28
`
`A.
`
`B.
`
`EPA Has Admitted Its Flagrant Violation of the ESA. .............. 28
`
`EPA’s Justification for Its ESA Failure Has No Basis in
`Law or Fact ................................................................................. 31
`
`II.
`
`EPA Violated FIFRA. ............................................................................. 37
`
`ii
`
`
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`A. The 2019 Registration Violated FIFRA’s Procedural
`Requirements. .............................................................................. 37
`
`B.
`
`EPA’s Conclusion that the Approved Sulfoxaflor Uses Is
`Better for the Environment Is Not Supported by
`Substantial Evidence. ................................................................... 39
`
`C. EPA Failed to Assess Sulfoxaflor Risks to Non-Honey
`Bees............................................................................................... 46
`
`III.
`
`The Court Should Vacate the 2019 Decision. ...................................... 51
`
`A. The Seriousness of EPA’s Violations Weighs Heavily in
`Favor of Vacatur. ......................................................................... 53
`
`B.
`
`The Disruptive Consequences Prong Also Weighs in
`Favor of Vacatur. ......................................................................... 57
`
`C. EPA Cannot Meet Its Burden for Remand Without
`Vacatur. ........................................................................................ 62
`
`CONCLUSION........................................................................................................... 65
`
`STATEMENT OF RELATED CASES ....................................................................... 67
`
`CERTIFICATE OF COMPLIANCE ......................................................................... 67
`
`iii
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`
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`
`
`Federal Cases
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`AFL–CIO v. Chao,
`496 F. Supp. 2d 76 (D.D.C. 2007) ........................................................................ 54
`
`All. for the Wild Rockies v. U.S. Forest Serv.,
`907 F.3d 1105 (9th Cir. 2018) ......................................................................... passim
`
`Allied-Signal, Inc. v. U.S. Nuclear Regul. Comm’n,
`988 F.2d 146 (D.C. Cir. 1993) .............................................................................. 58
`
`Babbitt v. Sweet Home Chapter of Cmtys. for a Great Or.,
`515 U.S. 687 (1995) ............................................................................................... 32
`
`Bennett v. Spear,
`520 U.S. 154 (1997) ............................................................................................... 62
`
`California Communities Against Toxics v. EPA,
`688 F.3d 174 (9th Cir. 2012) ........................................................................... 59, 60
`
`California ex rel. Lockyer v. U.S. Dep’t of Agric.,
`575 F.3d 999 (9th Cir. 2009) ..................................................................... 11, 12, 54
`
`Center for Biological Diversity v. EPA,
`861 F.3d 174 (D.C. Cir. 2017) .................................................................. 33, 34, 63
`
`City of Tacoma, Washington v. F.E.R.C.,
`460 F.3d 53 (D.C. Cir. 2006) ................................................................................ 34
`
`Conner v. Burford,
`848 F.2d 1441 (9th Cir. 1988) ............................................................................... 11
`
`Containerfreight Corp. v. United States,
`752 F.2d 419 (9th Cir. 1985) ................................................................................. 26
`
`Cottonwood Env’t Law Ctr. v. U.S. Forest Serv.,
`789 F.3d 1075 (9th Cir. 2015) ................................................................... 11, 31, 53
`
`
`
`iv
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`
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`
`
`Federal Cases (Cont’d)
`
`Page(s)
`
`Ctr. for Biological Diversity v. Bureau of Land Mgmt.,
`698 F.3d 1101 (9th Cir. 2012) ............................................................ 33, 34, 36, 60
`
`Ctr. for Env’t Health v. Vilsack,
`No. 15-cv-01690-JSC, 2016 WL 3383954 (N.D. Cal. June 20, 2016) .................. 62
`
`Ctr. for Food Safety v. Vilsack,
`734 F. Supp. 2d 948 (N.D. Cal. 2010) ...................................................... 57, 59, 60
`
`Defs. of Wildlife v. U.S. Env’t Prot. Agency,
`420 F.3d 946 (9th Cir. 2005) ................................................................................. 52
`
`Friends of Earth, Inc. v. Laidlaw Envtl. Serv. (TOC), Inc.,
`528 U.S. 167 (2000) ................................................................................................. 4
`
`Heartland Reg’l Med. Ctr. v. Sebelius,
`566 F.3d 193 (D.C. Cir. 2009) ........................................................................ 54, 61
`
`Humane Soc’y of U.S. v. Locke,
`626 F.3d 1040 (9th Cir. 2010) ............................................................................... 52
`
`Hunt v. Wash. State Apple Advert. Comm’n,
`432 U.S. 333 (1977) ................................................................................................. 4
`
`Idaho Farm Bureau Fed’n v. Babbitt,
`58 F.3d 1392 (9th Cir. 1995) ................................................................................. 61
`
`Karuk Tribe of Cal. v. U.S. Forest Serv.,
`681 F.3d 1006 (9th Cir. 2012) ......................................................................... 12, 26
`
`Massachusetts v. EPA,
`549 U.S. 497 (2007) ............................................................................................... 64
`
`N. Plains Res. Council v. Surface Transp. Bd.,
`668 F.3d 1067 (9th Cir. 2011) ............................................................................... 60
`
`Nat. Res. Def. Council v. Houston,
`146 F.3d 1118 (9th Cir. 1998) ............................................................................... 60
`
`
`
`v
`
`
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`
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`Federal Cases (Cont’d)
`
`Page(s)
`
`Nat. Res. Def. Council v. U.S. Dep’t of Interior,
`275 F. Supp. 2d 1136 (C.D. Cal. 2002) ................................................................ 61
`
`Nat. Res. Def. Council v. U.S. Env’t Prot. Agency,
`676 F. Supp. 2d 307 (S.D.N.Y. 2009) .............................................................. 54, 63
`
`Nat’l Ass’n of Home Builders v. Defs. of Wildlife,
`551 U.S. 644 (2007) ............................................................................................... 10
`
`Nat’l Family Farm Coal. v. Env’t Prot. Agency,
`960 F.3d 1120 (9th Cir. 2020) ......................................................................... passim
`
`Nat’l Parks Conservation Ass’n v. Jewell,
`62 F. Supp. 3d 7 (D. D.C. 2014) ........................................................................... 54
`
`Nat’l Wildlife Fed’n v. Nat’l Marine Fisheries Serv.,
`524 F.3d 917 (9th Cir. 2008) ................................................................................. 61
`
`New Hampshire v. Maine,
`532 U.S. 742 (2001) ......................................................................................... 29, 32
`
`Ocean Advocates v. U.S. Army Corps of Eng’rs,
`361 F.3d 1108 (9th Cir. 2004) ............................................................................... 27
`
`Pollinator Stewardship Council v. EPA,
`806 F.3d 520 (9th Cir. 2015) ........................................................................... passim
`
`Rocky Mt. Farmers Union v. Corey,
`740 F.3d 507 (9th Cir. 2014) ................................................................................ 64
`
`Se. Alaska Conservation Council v. Fed. Highway Admin.,
`649 F.3d 1050 (9th Cir. 2011) ............................................................................... 60
`
`Sierra Club v. Marsh,
`816 F.2d 1376 (9th Cir. 1987) ............................................................................... 11
`
`Standing Rock Sioux Tribe v. U.S. Army Corps of Eng’rs,
`--- F.3d ---, No. 20-5197, 2021 WL 244862 (D.C. Cir. Jan. 26, 2021) ............. 55, 56
`
`
`
`vi
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`
`
`Federal Cases (Cont’d)
`
`Page(s)
`
`Tenn. Valley Auth. v. Hill,
`437 U.S. 153 (1978) .............................................................................. 1, 10, 33, 60
`
`Thomas v. Peterson,
`753 F.2d 754 (9th Cir. 1985) ..................................................................... 11, 31, 53
`
`United Farm Workers of Am. v. Env’t Prot. Agency,
`592 F.3d 1080 (9th Cir. 2010) ................................................................................. 3
`
`Federal Statutes
`
`5 U.S.C. § 706(2)(A) .................................................................................................... 26
`
`7 U.S.C. § 136(bb) ......................................................................................................... 9
`
`7 U.S.C. § 136a(c) ......................................................................................................... 7
`
`7 U.S.C § 136a(c)(2)(A) ................................................................................................. 8
`
`7 U.S.C. § 136a(c)(4) ......................................................................................... 9, 37, 38
`
`7 U.S.C. § 136a(c)(5) ..................................................................................................... 8
`
`7 U.S.C. § 136a(d)(1)(C) ............................................................................................. 41
`
`7 U.S.C. § 136a(g) ................................................................................................. 31, 32
`
`7 U.S.C. § 136n(b)............................................................................................. 3, 26, 27
`
`16 U.S.C. § 1532(5)(A) ................................................................................................ 11
`
`16 U.S.C. § 1536(a)(2) .............................................................................. 11, 26, 28, 29
`
`Federal Regulations
`
`40 C.F.R § 23.6 .............................................................................................................. 3
`
`40 C.F.R. § 152.3 ............................................................................................ 10, 38, 39
`
`40 C.F.R. § 152.102 ................................................................................................ 9, 37
`
`40 C.F.R. § 152.115 ...................................................................................................... 7
`vii
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`
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`Federal Regulations (Cont’d)
`
`Page(s)
`
`40 C.F.R. § 156.10 ........................................................................................................ 7
`
`40 C.F.R. § 158.1(b)(1) .................................................................................................. 8
`
`40 C.F.R. § 158.500-.510 .............................................................................................. 8
`
`40 C.F.R. § 158.630-.660 .............................................................................................. 8
`
`40 C.F.R. § 158.1300 .................................................................................................... 8
`
`50 C.F.R. § 402.01(b) ............................................................................................ 11, 26
`
`50 C.F.R. § 402.02 ................................................................................................ 11, 28
`
`50 C.F.R. §§ 402.12-402.16 ........................................................................................ 53
`
`50 C.F.R. § 402.13 ...................................................................................................... 12
`
`50 C.F.R. § 402.14(a) ............................................................................... 11, 12, 14, 26
`
`50 C.F.R. § 402.14(b)(1) .............................................................................................. 12
`
`Rules
`
`Ninth Cir. Rule 30-1.4(a) .............................................................................................. 3
`
`Other Authorities
`
`82 Fed. Reg. 3,186, 3,187 (Jan. 11, 2017) .................................................................. 30
`
`EPA, Conventional Reduced Risk Pesticide Program,
`https://www.epa.gov/pesticide-registration/conventional-reduced-
`risk-pesticide-program#:~:text=OP)%20Alternative%20Status-
`,What%20is%20the%20Conventional%20Reduced%20Risk%20Pe
`sticide%20Program%3F,environment%20than%20existing%20con
`ventional%20alternatives ....................................................................................... 41
`
`EPA, Guidance for Assessing Pesticide Risks to Bees (June 19, 2014),
`available at https://www.epa.gov/sites/production/files/2014-
`06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf ................ 15
`
`
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`
`
`Other Authorities (Cont’d)
`
`Page(s)
`
`EPA, Imidacloprid Proposed Interim Registration Review Decision (Jan.
`2020), available at
`https://www.epa.gov/sites/production/files/2020-
`01/documents/imidacloprid_pid_signed_1.22.2020.pdf .................................... 41
`
`EPA, Interim Approaches for National-Level Pesticide Endangered Species Act
`Assessment Based on the Recommendations of the National Academy of
`Sciences April 2013 Report (July 2017), available at
`https://www.epa.gov/sites/production/files/2015-
`07/documents/interagency.pdf ............................................................................. 13
`
`EPA, Overview of the Ecological Risk Assessment Process 46-47 (Jan. 2004),
`https://www.epa.gov/sites/production/files/2014-
`11/documents/ecorisk-overview.pdf ....................................................................... 8
`
`EPA, Public Participation Process for Registration Actions,
`https://www.epa.gov/pesticide-registration/public-participation-
`process-registration-actions ..................................................................................... 10
`
`EPA, Restricted Use Product Summary Report (Oct. 24, 2019), available at
`https://www.epa.gov/sites/production/files/2019-
`10/documents/rup-report-oct2019.pdf ................................................................. 41
`
`EPA, Revised Method for National Level Listed Species Biological Evaluations
`of Conventional Pesticides (Mar. 12, 2020), available at
`https://www3.epa.gov/pesticides/nas/revised/revised-method-
`march2020.pdf ....................................................................................................... 13
`
`EPA’s Registration of the New Active Ingredient Inpyrfluxam, available at
`https://www.regulations.gov/document?D=EPA-HQ-OPP-2018-
`0038-0039 .............................................................................................................. 44
`
`Nat’l Academy of Sciences, Assessing Risks to Endangered and Threatened
`Species from Pesticides (2013),
`https://www.nap.edu/catalog/18344/assessing-risks-to-endangered-
`and-threatened-species-from-pesticides ................................................................... 13
`
`
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`
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`Other Authorities (Cont’d)
`
`Page(s)
`
`U.S. Fish & Wildlife Serv., Species Status Assessment 4 (June 2016),
`available at
`https://www.fws.gov/midwesT/endangered/insects/rpbb/pdf/SSA
`ReportRPBBwAdd.pdf ........................................................................................... 30
`
`U.S. Gov’t Accountability Office, Bee Health: USDA and EPA Should
`Take Additional Actions to Address Threats to Bee Populations 39 (Feb.
`2016), available at https://www.gao.gov/assets/680/675109.pdf .................. 50, 51
`
`
`
`
`
`
`
`
`
`x
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`
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`
`2019 Registration
`
`Academy
`
`APA
`
`CFS Petitioners
`
`Dow
`
`EPA
`
`ESA
`
`FIFRA
`
`FWS
`
`GAO
`
`Interim Approaches
`
`LD50
`
`GLOSSARY OF ABBREVIATIONS
`
`EPA’s July 12, 2019 registration decision adding new
`uses of sulfoxaflor on alfalfa, cacao, citrus, corn, cotton,
`cucurbits, grains, pineapple, sorghum, soybeans,
`strawberries, and tree plantations, as well as amending
`preexisting uses of sulfoxaflor
`
`National Academy of Sciences
`
`Administrative Procedure Act
`
`Center for Food Safety and Center for Biological
`Diversity, Petitioners in No. 19-72109
`
`Respondent-Intervenor Dow Agrosciences LLC
`
`Respondent U.S. Environmental Protection Agency
`
`Endangered Species Act
`
`Federal Insecticide, Fungicide, and Rodenticide Act
`
`U.S. Fish and Wildlife Service
`
`U.S. Government Accountability Office
`
`A joint guidance issued by the EPA, U.S. Fish and
`Wildlife Service, National Marine Fisheries Service, and
`the U. S. Department of Agriculture on the ESA
`consultation process, based on the recommendations of
`the National Academy of Sciences
`
`A standard of measurement of acute toxicity used by
`EPA, stated in milligrams of pesticide per kilogram of
`body weight (mg/kg), which represents the individual
`dose of a pesticide required to kill 50 percent of a
`population of test animals
`
`NEPA
`
`National Environmental Policy Act
`
`xi
`
`
`
`
`
`
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`PSC Petitioners
`
`Pollinator Stewardship Council, American Beekeeping
`Federation, and Jeffrey S. Anderson, Petitioners in No.
`19-72280
`
`Revised Methods
`
`EPA’s guidance on the three steps of its ESA
`consultation process
`
`Wildlife Agencies
`
`U.S. Fish and Wildlife Service and National Marine
`Fisheries Service
`
`xii
`
`
`
`
`
`
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`
`
`INTRODUCTION
`
`This petition for review challenges an unexpected July 12, 2019 decision (the
`
`2019 Registration) by Respondent U.S. Environmental Protection Agency (EPA) to
`
`authorize the spraying of the insecticide sulfoxaflor across the United States, over
`
`major agricultural crops, such as soybean, cotton, citrus, apples, and strawberries,
`
`and without the protective measures EPA itself previously deemed necessary to
`
`prevent harm to honey bees. EPA nonetheless concluded that approving sulfoxaflor
`
`uses in this manner would not result in unreasonable adverse effects on the
`
`environment, and granted unconditional registration under the Federal Insecticide,
`
`Fungicide, and Rodenticide Act (FIFRA).
`
`EPA’s conclusion is wrong and its decision unlawful, first for a simple reason
`
`that EPA has now admitted to this Court: EPA intentionally disregarded its
`
`mandatory duties under the Endangered Species Act (ESA) to insure that sulfoxaflor
`
`does not jeopardize the existence of endangered species, before issuing the 2019
`
`Registration. This Court previously vacated the initial sulfoxaflor registration after
`
`holding EPA violated FIFRA’s “unreasonable adverse effect” standard, a more
`
`lenient standard than the ESA’s mandate that agencies prioritize endangered species
`
`protection. See Pollinator Stewardship Council v. EPA (Pollinator I), 806 F.3d 520, 532
`
`(9th Cir. 2015); Tenn. Valley Auth. v. Hill, 437 U.S. 153, 185 (1978).
`
`
`
`1
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`
`
`The 2019 Registration is also unlawful under FIFRA. EPA issued the 2019
`
`Registration without providing an opportunity for public input, as it was required to
`
`do under the statute. And, despite the fact that the data before EPA shows that the
`
`approved sulfoxaflor uses can harm honey bees, and pose even greater risks to other
`
`bumble bees, leaf cutter bees, native bees, and wild bees, EPA relied on an
`
`inaccurate, skewed analysis comparing sulfoxaflor to only six of the most toxic
`
`insecticides to conclude that authorizing sulfoxaflor use across the U.S. agricultural
`
`landscape would be beneficial to the environment.
`
`Consequently, more than a decade after the initial application to register
`
`sulfoxaflor use, EPA still has “no real idea whether sulfoxaflor [would] cause
`
`unreasonable adverse effects on bees,” Pollinator I, 806 F.3d at 532, not to mention
`
`endangered and threatened species. EPA still has not taken the legally required
`
`steps, mandated by the ESA and outlined by EPA’s own guidance, to insure
`
`protection of our nation’s most imperiled species already in danger of extinction.
`
`This Court should grant this petition for review, hold that EPA violated FIFRA and
`
`the ESA, and vacate the 2019 Registration.
`
`
`
`
`
`
`
`
`
`2
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`
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`JURISDICTIONAL STATEMENT
`
`Petitioners Center for Food Safety and Center for Biological Diversity
`
`(collectively CFS Petitioners) seek review of the 2019 Registration by EPA to register
`
`new uses of the insecticide sulfoxaflor under section 16(b) of FIFRA. CFSER-3-32.1
`
`This Court has jurisdiction under FIFRA, which provides for review in the courts of
`
`appeals of “any order issued by [EPA] following a public hearing.” 7 U.S.C.
`
`§ 136n(b), see United Farm Workers of Am. v. Env’t Prot. Agency, 592 F.3d 1080,
`
`1082-83 (9th Cir. 2010). EPA’s 2019 Registration was issued with public notice and
`
`comments on EPA’s prior registrations of sulfoxaflor uses. CFSER-4-5; see Nat’l
`
`Family Farm Coal. v. Env’t Prot. Agency, 960 F.3d 1120, 1132 (9th Cir. 2020) (holding
`
`jurisdiction proper where challenged EPA registration followed notice and comment
`
`on a prior decision). CFS Petitioners had submitted comments on EPA’s previous
`
`sulfoxaflor decisions, and timely filed this petition for review. 7 U.S.C. § 136n(b),
`
`40 C.F.R § 23.6; see CFSER-224-33; CFSER-219-23; CFSER190-211.
`
`
`
`1 Pursuant to Circuit Rule 30-1.4(a), CFS Petitioners include the challenged
`2019 Registration in volume 1 of CFS Petitioners’ Excerpts of Record (CFSER). For
`other cited record documents, CFS Petitioners cite to Pollinator Stewardship
`Council Petitioners (PSC Petitioners)’s excerpts of record, referred to as “PSCER”
`along with their volume and Bates number, if they are produced therein. See PSC
`Pet’rs’ Excerpts of Record, ECF Nos. 38-1 to 38-6.
`
`
`
`3
`
`
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`
`
`CFS Petitioners also satisfy the requirements of Article III standing for their
`
`ESA and FIFRA claims. See Friends of Earth, Inc. v. Laidlaw Envtl. Serv. (TOC), Inc.,
`
`528 U.S. 167, 180-81 (2000); Hunt v. Wash. State Apple Advert. Comm’n, 432 U.S.
`
`333, 343 (1977). The challenged registration directly injures Petitioners’ members’
`
`environmental and aesthetic interests in seeing and protecting federally endangered
`
`and threatened species. See CFS’s Pet’rs’ Remand Opp’n Addendum, ECF No. 59-2,
`
`at CFS_A002-9 (Newman Decl. ¶¶ 6-29) (interests in endangered whooping crane
`
`and rusty patched bumble bee), CFS_A012-19 (Celano Decl. ¶¶ 6-25) (interests in
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`endangered mammals, birds, and reptiles), CFS_A023-28 (Buse Decl. ¶¶ 9-26)
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`(interests in endangered Indiana bat, Karner blue butterfly, Hine’s emerald
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`dragonfly, Mitchell’s satyr butterfly), CFS_A032-36 (Williams Decl. ¶¶ 5-14)
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`(interests in endangered fishes and mussels); CFS_A049-54 (Burd Decl. ¶¶ 23-31)
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`(interests in the preservation of the Fender’s blue butterfly, Oregon silverspot, and
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`Chiricahua leopard frog). CFS Petitioners also have members whose recreational
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`and vocational interests as beekeepers and gardeners in preserving the health of our
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`nation’s pollinator species are being injured by EPA’s 2019 Registration. See id., at
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`CFS_A056-59 (Burkey Decl. ¶¶ 5-14) (gardening and recreational interests in
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`pollinator species), CFS_A062-64 (Holterman Decl. ¶¶ 6-14) (gardening,
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`Case: 19-72109, 02/16/2021, ID: 12005376, DktEntry: 71, Page 17 of 196
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`beekeeping, and bird-watching interests), CFS_A068-72 (Gregory Decl. ¶¶ 6-16)
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`(gardening and birding interests).
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`ISSUES PRESENTED
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`1. Whether the Court should hold that EPA violated the ESA by failing
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`to comply with the ESA’s section 7 consultation procedures concerning sulfoxaflor’s
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`effects on threatened and endangered species and their critical habitats before
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`issuing the challenged decision, where hundreds of species are potentially affected,
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`over millions of acres, and where EPA now admits itself that it failed to so comply
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`and is in violation of the statute;
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`2. Whether EPA violated FIFRA by issuing the 2019 Registration’s new
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`uses of sulfoxaflor but failed to solicit public input despite pesticide new uses
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`requiring notice and comment;
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`3. Whether EPA’s conclusion that the 2019 Registration authorizing
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`sulfoxaflor spraying on numerous agricultural crops would not result in
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`unreasonable adverse effects on the environment is supported by substantial
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`evidence, as required under FIFRA, where EPA failed to assess the impacts of
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`sulfoxaflor exposure on non-honey bees, and where EPA supported its registration
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`decision with an inaccurate, flawed alternative pesticide analysis; and
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`Case: 19-72109, 02/16/2021, ID: 12005376, DktEntry: 71, Page 18 of 196
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`4. Whether the Court should vacate the 2019 Registration, where EPA
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`has committed serious errors of law in violating both the ESA and FIFRA and where
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`EPA cannot meet its heavy burden to show this is the rare exceptional instance
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`where remand without vacatur is warranted because it is the more environmentally
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`protective remedy.
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`STATEMENT OF THE CASE
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`Sulfoxaflor is a relatively new insecticidal active ingredient, developed by
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`Intervenor Dow Agrosciences, LLC (Dow) , which kills insects by disrupting their
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`central nervous system. 3-PSCER-359. EPA classifies sulfoxaflor as “the only member
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`of the sulfoxamine subclass of neonicotinoid insecticides,” a now infamous group of
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`insecticides known for its deadly impact on honey bees and pollinator insects vital to
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`U.S. agriculture, and on threatened and endangered species on the brink of
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`extinction. 4-PSCER-782-83, 4-PSCER-844, 4-PSCER-880; 6-PSCER-1267; Pollinator
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`I, 806 F.3d at 532 (9th Cir. 2015); 5-PSCER-960 (“Sulfoxaflor can be considered to
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`be a neonicotinoid.”).
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`When bees and other pollinators forage on pollen or nectar from
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`neonicotinoid-treated plants, or are otherwise exposed to extremely small doses of
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`these insecticides, tremors, paralysis and death result. 4-PSCER-782; 4-PSCER-783;
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`Case: 19-72109, 02/16/2021, ID: 12005376, DktEntry: 71, Page 19 of 196
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`4-PSCER-880. Like other neonicotinoids, sulfoxaflor is a “systemic” insecticide,
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`meaning that it is absorbed into the treated plant and distributed via the plant’s
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`vascular system. 4-PSCER-782. As a result, spraying a plant with sulfoxaflor not only
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`kills insects that come into direct contact with spray droplets, but also renders the
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`plant itself—including the leaves, stem, flowers, nectar and pollen—highly toxic to
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`insects for long periods thereafter. Id.; see Pollinator I, 806 F.3d at 523. Consequently,
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`the widespread use of sulfoxaflor alongside other neonicotinoids and pesticides have
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`exacerbated the loss of bees (both honey and non-honey bees) and other vital
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`pollinators, and have worsened the fate of endangered species already teetering on
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`the brink of extinction. See 6-PSCER-1267.
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`Federal Insecticide, Fungicide, and Rodenticide Act.
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`FIFRA charges EPA with regulating the sale and use of pesticides. Before any
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`pesticide can be sold or used in the United States, EPA must register the pesticide. A
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`pesticide registration is a license that includes the terms and conditions under which
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`the pesticide may be lawfully sold, distributed, and used, including specific uses of
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`the pesticide, what the pesticide can be sprayed on, and instructions or limitations of
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`the pesticide use. See 7 U.S.C. § 136a(c); 40 C.F.R. §§ 152.115, 156.10.
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`Case: 19-72109, 02/16/2021, ID: 12005376, DktEntry: 71, Page 20 of 196
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`In passing FIFRA, Congress tasked EPA with implementing the specific data
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`that an applicant must submit to support the pesticide use, consistent with the
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`statute’s mandates. See 7 U.S.C § 136a(c)(2)(A). EPA has promulgated regulations
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`specifying “the minimum data and information EPA typically requires” to analyze
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`and approve a pesticide registration application. 40 C.F.R. § 158.1(b)(1). EPA
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`requires data on a pesticide’s toxicology, environmental fate, and ecological effects.
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`See, e.g., 40 C.F.R. §§ 158.500-.510, 158.630-.660, 158.1300. From these and other
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`data submissions, EPA prepares an ecological risk assessment to evaluate the risks of
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`pesticide exposure to different taxonomic groups, including risks of pesticide
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`exposure to endangered species.2 See, e.g., 4-PSCER-879-880.
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`EPA may only register a pesticide for a specific use if it determines, among
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`other factors, that the proposed use of the pesticide “will perform its intended
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`function without unreasonable adverse effects on the environment.” 7 U.S.C.
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`§ 136a(c)(5). The meaning of “unreasonable adverse effect” is broad, and includes
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`“any unreasonable risk to man or the environment, taking into account the
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`economic