throbber
Case: 20-70787, 05/18/2021, ID: 12116743, DktEntry: 80-1, Page 1 of 95
`
`Nos. 20-70787, 20-70801
`
`
`
`
`UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`
`
`
`
`
`
`
`
`NATURAL RESOURCES DEFENSE COUNCIL, et al.,
`Petitioners,
`
`v.
`
`UNITED STATES ENVIRONMENTAL PROTECTION AGENCY,
`Respondent.
`
`
`
`RURAL COALITION, et al.,
`Petitioners,
`
`v.
`
`UNITED STATES ENVIRONMENTAL PROTECTION AGENCY,
`Respondent.
`
`
`
`
`
`
`On Petition for Review of Final Agency Action of the
`United States Environmental Protection Agency
`
`
`
`
`BRIEF FOR U.S. ENVIRONMENTAL PROTECTION AGENCY
`
`
`
`
`
`Of Counsel:
`
`DEVI CHANDRASEKARAN
`Attorney Advisor
`
`
`Jean E. Williams
`Acting Assistant Attorney General
`Bruce S. Gelber
`Deputy Assistant Attorney General
`
`BENJAMIN CARLISLE
`
`

`

`Case: 20-70787, 05/18/2021, ID: 12116743, DktEntry: 80-1, Page 2 of 95
`
`FORREST PITTMAN
`Attorney Advisor
`Office of General Counsel
`U.S. Environmental Protection
`Agency
`Mail Code 2333A
`1200 Pennsylvania Avenue, N.W.
`Washington, DC 20460
`
`U.S. Environmental Protection
`Agency
`
`
`Senior Attorney
`ROBERT WILLIAMS
`Senior Trial Attorney
`Environment and Natural Resources
`Division
`U.S. Department of Justice
`Post Office Box 7411
`Washington, D.C. 20044
`(202) 514-9771 (Carlisle)
`Benjamin.Carlisle@usdoj.gov
`(202) 305-0206 (Williams)
`Robert.P.Williams@usdoj.gov
`
`
`

`

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`
`TABLE OF CONTENTS
`
`TABLE OF AUTHORITIES ...................................................................... iv 
`
`GLOSSARY ............................................................................................... xii 
`
`INTRODUCTION ....................................................................................... 1 
`
`STATEMENT OF JURISDICTION ........................................................... 3 
`
`STATEMENT OF THE ISSUES ................................................................ 3 
`
`PERTINENT STATUTES AND REGULATIONS .................................... 4 
`
`STATEMENT OF THE CASE ................................................................... 5 
`
`I. 
`
`Statutory and regulatory background. ............................................. 5 
`
`A. 
`
`Federal Insecticide, Fungicide, and Rodenticide
`Act (“FIFRA”). .......................................................................... 5 
`
`B.  Endangered Species Act (“ESA”). ............................................ 9 
`
`II.  The glyphosate registration review. ............................................... 10 
`
`A.  Glyphosate. ............................................................................. 10 
`
`B.  Overview of the glyphosate registration review
`process. ................................................................................... 13 
`
`C. 
`
`The Interim Decision. ............................................................ 14 
`
`D.  Motion for voluntary remand. ............................................... 16 
`
`SUMMARY OF ARGUMENT .................................................................. 17 
`
`STANDARD OF REVIEW ........................................................................ 19 
`
`ARGUMENT ............................................................................................. 22 
`
`i
`
`

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`I. 
`
`The Court should not consider Petitioners’ extra-record
`evidence. ........................................................................................... 22 
`
`II.  EPA’s conclusion that glyphosate does not pose human-
`health risks of concern is supported by substantial
`evidence. ........................................................................................... 24 
`
`III.  Petitioners’ attempts to contradict EPA’s expert
`human-health analysis misconstrue the record. ........................... 30 
`
`A.  EPA thoroughly considered cancer risk and its
`decision is supported by substantial evidence. ..................... 30 
`
`B. 
`
`Substantial evidence supports EPA’s analysis of
`workers’ skin exposure to glyphosate. .................................. 40 
`
`C.  EPA’s consideration of glyphosate formulations
`was consistent with its regulations and supported
`by substantial evidence. ......................................................... 44 
`
`D.  EPA thoroughly assessed human-health risks
`raised in comments. ............................................................... 56 
`
`IV.  Petitioners fail to show that EPA is violating the ESA. ................ 57 
`
`V. 
`
`Petitioners’ ESA claim is prudentially moot. ................................. 65 
`
`VI.  Remedy. ........................................................................................... 69 
`
`A. 
`
`Petitioners’ are wrong in claiming that vacatur of
`the Interim Decision means vacating hundreds of
`glyphosate registrations. ....................................................... 69 
`
`B.  Vacatur of over five hundred glyphosate
`registrations is not an appropriate remedy. ......................... 74 
`
`CONCLUSION ......................................................................................... 77 
`
`STATEMENT OF RELATED CASES ..................................................... 78 
`
`ii
`
`

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`CERTIFICATE OF COMPLIANCE ........................................................ 79 
`
`CERTIFICATE OF SERVICE .................................................................. 80 
`
`ADDENDUM ............................................................................................ 81 
`
`
`
`
`
`iii
`
`

`

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`
`TABLE OF AUTHORITIES
`
`Cases
`
`A.L. Mechling Barge Lines v. United States,
`368 U.S. 324 (1961) ............................................................................... 66
`
`
`Alaska Survival v. Surface Transp. Bd.,
`705 F.3d 1073 (9th Cir. 2013) ............................................................... 43
`
`
`Alon Ref. Krotz Springs, Inc. v. EPA,
`936 F.3d 628 (D.C. Cir. 2019) ............................................................... 36
`
`
`Arkansas v. Oklahoma,
`503 U.S. 91 (1992) ................................................................................. 20
`
`
`ASARCO, Inc. v. Occupational Safety & Health Admin.,
`746 F.2d 483 (9th Cir. 1984) ..................................................... 21, 39, 44
`
`
`Ass’n of Data Processing Serv. Orgs., Inc. v. Bd. of Governors of Fed.
`Reserve Sys.,
`745 F.2d 677 (D.C. Cir. 1984) ............................................................... 20
`
`
`Baltimore Gas & Elec. Co. v. NRDC,
`462 U.S. 87 (1983) ................................................................................. 21
`
`
`Bonnichsen v. United States,
`357 F.3d 962 (9th Cir. 2004) ................................................................. 20
`
`
`Bowman Transp., Inc. v. Ark.-Best Freight Sys., Inc.,
`419 U.S. 281 (1974) ......................................................................... 20, 51
`
`
`Cal. Cmtys. Against Toxics v. EPA,
`688 F.3d 989 (9th Cir. 2012) ........................................................... 75, 76
`
`
`Cal., Dep't of Educ. v. Bennett,
`843 F.2d 333 (9th Cir. 1988) ................................................................. 40
`
`iv
`
`

`

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`
`
`Cal. Sportfishing Prot. All. v.FERC,
`472 F.3d 593 (9th Cir. 2006) ................................................................. 61
`
`
`Camp v. Pitts,
`411 U.S. 138 (1973) ............................................................................... 22
`
`
`Chamber of Commerce v. U.S. Dep’t of Energy,
`627 F.2d 289 (D.C. Cir. 1980) ......................................................... 66, 67
`
`
`Chamber of Commerce v. SEC,
`412 F.3d 133 (D.C. Cir. 2005) ............................................................... 52
`
`
`Cmtys. for a Better Env't v. EPA,
`748 F.3d 333 (D.C. Cir. 2014) ............................................................... 33
`
`
`Conner v. Burford,
`848 F.2d 1441 (9th Cir. 1988) ............................................................... 63
`
`
`Ctr. for Biological Diversity v. U.S. Fish & Wildlife Serv.,
`450 F.3d 930 (9th Cir. 2006) ........................................................... 22, 23
`
`
`Deutsche Bank Nat’l Tr. Co. v. FDIC,
`744 F.3d 1124 (9th Cir. 2014) ............................................................... 66
`
`
`Dickinson v. Zurko,
`527 U.S. 150 (1999) ............................................................................... 19
`
`
`Earth Island Inst. v. Carlton,
`626 F.3d 462 (9th Cir. 2010) ................................................................. 21
`
`
`FCC v. Fox TV Stations, Inc.,
` 556 U.S. 502 (2009) ............................................................................... 72
`
`FCC v. Prometheus Radio Project,
`141 S. Ct. 1150 (2021) ........................................................................... 52
`
`
`
`v
`
`

`

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`Fla. Power & Light Co. v. Lorion,
`470 U.S. 729 (1985) ............................................................................... 22
`
`
`Friends of the Earth v. Hintz,
`800 F.2d 822 (9th Cir. 1986) ................................................................. 23
`
`
`Friends of the Santa Clara River v. USACE,
`887 F.3d 906 (9th Cir. 2009) ................................................................. 67
`
`
`Hunt v. Imperial Merch. Servs.,
`560 F.3d 1137 (9th Cir. 2018) ............................................................... 10
`
`
`Lands Council v. McNair,
`537 F.3d 981 (9th Cir. 2008),
` overruled in part on other grounds by 555 U.S. 7 (2008 ......... 17, 20, 40,
` ......................................................................................................... 52, 56
`
`
`Lands Council v. McNair,
`629 F.3d 1070 (9th Cir. 2010) ............................................................... 22
`
`
`Lands Council v. Powell,
`379 F.3d 738 (9th Cir. 2004) ................................................................. 42
`
`
`Lane Cty. Audubon Soc’y v. Jamison,
`958 F.2d 290 (9th Cir. 1992) ................................................................. 63
`
`
`League of Wilderness Defs./Blue Mountains Biodiversity Project v.
`Connaughton,
`752 F.3d 755 (9th Cir. 2014) ................................................................. 43
`
`
`Lee v. City of Los Angeles,
`250 F.3d 668 (9th Cir. 2001) ................................................................. 23
`
`
`Nathan Kimmel, Inc. v. DowElanco,
`275 F.3d 1199 (9th Cir. 2002) ................................................................. 5
`
`
`Nat'l Ass'n of Wheat Growers v. Becerra,
`468 F. Supp. 3d 1247 (E.D. Cal. 2020) ................................................. 32
`
`vi
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`

`

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`
`Nat'l Family Farm Coal. v. EPA,
`966 F.3d 893 (9th Cir. 2020) ............................. 10, 39, 52, 55, 74, 75, 76
`
`
`Nat. Res. Def. Council v. EPA,
`735 F.3d 873 (9th Cir. 2013) ............................. 19, 21, 31, 33, 39, 44, 51
`
`
`N. Plains Res. Council, Inc. v. Surface Transp. Bd.,
`668 F.3d 1067 (9th Cir. 2011) ............................................................... 42
`
`
`Norton v. S. Utah Wilderness All.,
`542 U.S. 55 (2004) ................................................................................. 72
`
`
`Nw. Food Processors Ass’n v. Reilly,
`886 F.2d 1075 (9th Cir. 1989) ............................................................... 20
`
`
`Padgett v. Wright,
`587 F.3d 983 (9th Cir. 2009) ........................................................... 23, 45
`
`
`Pollinator Stewardship Council v. EPA,
`806 F.3d 520 (9th Cir. 2015) ................................................................. 21
`
`
`Reckitt Benckiser Inc. v. EPA,
`613 F.3d 1131 (D.C. Cir. 2010) ................................................... 7, 70, 71
`
`
`Reeve Aleutian Airways v. United States,
`889 F.2d 1139 (D.C. Cir. 1989) ............................................................. 67
`
`
`Rybachek v. EPA,
` 904 F.2d 1276 (9th Cir. 1990) ............................................................... 22
`
`Sierra Club v. EPA,
`671 F.3d 955 (9th Cir. 2012) ................................................................. 42
`
`
`Singh-Kaur v. INS,
`183 F.3d 1147 (9th Cir. 1999) ............................................................... 19
`
`
`
`vii
`
`

`

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`Sw. Ctr. for Biological Diversity v. U.S. Forest Serv.,
`100 F.3d 1443 (9th Cir. 1996) ................................................................. 9
`
`
`United States v. Kimble,
`107 F.3d 712 (9th Cir. 1997) ................................................................. 43
`
`
`Western Watersheds Project v. Matejko,
`468 F.3d 1099 (9th Cir. 2006) ............................................................... 61
`Statutes
`5 U.S.C. § 701 ........................................................................................... 21
`
` 5
`
` 7
`
` 7
`
` 7
`
` 7
`
` U.S.C. § 706(2)(A) .................................................................................. 21
`
` U.S.C. § 136(bb) ....................................................................................... 6
`
` U.S.C. § 136a-1 ...................................................................................... 13
`
` U.S.C. § 136a ......................................................................................... 75
`
` U.S.C. § 136a(a) ................................................................................. 5, 69
`
` U.S.C. § 136a(c)........................................................................................ 5
`
` U.S.C. § 136a(c)(1)(A)-(F) ........................................................................ 5
`
` U.S.C. § 136a(c)(2)(B) .............................................................................. 6
`
` U.S.C. § 136a(c)(5) ................................................................................... 6
`
` U.S.C. § 136a(d)(1) ................................................................................... 5
`
` U.S.C. § 136a(g) ....................................................................................... 6
`
` U.S.C. § 136a(g)(1)(A)(i) ........................................................................ 69
`
` U.S.C. § 136a(g)(1)(A)(iii) .......................................................... 13, 45, 73
`
`viii
`
` 7
`
` 7
`
` 7
`
` 7
`
` 7
`
` 7
`
` 7
`
` 7
`
`
`
`

`

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`7 U.S.C. § 136a(g)(1)(A)(v) ................................................. 9, 18, 57, 70, 73
`
` 7
`
` 7
`
` 7
`
` U.S.C. § 136n(b) ................................................................................. 3, 19
`
`
`16 U.S.C. § 1536(a)(2) ................................................................................. 9
`
`16 U.S.C. § 1536(b)(3) ............................................................................... 10
`
`21 U.S.C. § 346a........................................................................................ 50
`
`28 U.S.C. § 2401(a) ................................................................................... 45
`Rules
`Fed. R. Evid. 201....................................................................................... 23
`Code of Federal Regulations
`40 C.F.R. pt. 152 ......................................................................................... 5
`
`40 C.F.R. § 152.3 ....................................................................................... 46
`
`40 C.F.R. § 155.40 ............................................................................. 6, 7, 45
`
`40 C.F.R. § 155.40(a)(2) ............................................................................ 70
`
`40 C.F.R. § 155.42 ....................................................................................... 6
`
`ix
`
` U.S.C. § 136a(g)(2) ................................................................................... 6
`
` U.S.C. § 136d(a)(1) ................................................................................. 76
`
` U.S.C. § 136d(b)-(c) .................................................................................. 7
`
` U.S.C. § 136d(b) ........................................................... 7, 8, 57, 70, 71, 72
`
` U.S.C. § 136d(d) ....................................................................................... 8
`
` U.S.C. § 136j(a)(2)(G) ........................................................................ 6, 75
`
` 7
`
` 7
`
` 7
`
` 7
`
`

`

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`
`
`40 C.F.R. § 155.42(a) ................................................................................ 45
`
`40 C.F.R. § 155.48 ....................................................................................... 6
`
`40 C.F.R. § 155.50 ....................................................................................... 6
`
`40 C.F.R. § 155.53 ....................................................................................... 7
`
`40 C.F.R. § 155.53(a) .......................................................................... 46, 63
`
`40 C.F.R. § 155.53(b) ................................................................................ 46
`
`40 C.F.R. § 155.53(b)(2) ............................................................................ 46
`
`40 C.F.R. § 155.56 ....................................................................................... 7
`
`40 C.F.R. § 155.57 ....................................................................................... 6
`
`40 C.F.R. § 155.58(b)(2) .............................................................................. 7
`
`40 C.F.R. § 155.58(b)(4) .............................................................................. 7
`
`40 C.F.R. § 155.58(d) ................................................................................ 72
`
`40 C.F.R pt. 158 ................................................................................... 5, 55
`
`40 C.F.R. § 158.110(b) .............................................................................. 41
`
`40 C.F.R. § 158.500(d) .............................................................................. 41
`
`40 C.F.R. § 158.500(e) ............................................................................... 41
`
`40 C.F.R. pt. 164 ......................................................................................... 8
`
`40 C.F.R. pt. 180 ....................................................................................... 50
`
`50 C.F.R. § 402.02 ................................................................................. 9, 58
`
`x
`
`

`

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`
`50 C.F.R. § 402.13 ..................................................................................... 10
`
`50 C.F.R. § 402.13(c) ................................................................................. 10
`
`50 C.F.R. § 402.14 ..................................................................................... 10
`
`50 C.F.R. § 402.14(a) ............................................................................ 9, 58
`
`50 C.F.R. § 402.14(b)(1) ........................................................................ 9, 10
`
`50 C.F.R. § 402.46 ..................................................................................... 10
`
`State Regulations
`Cal. Code Regs. 27 § 25306(a) .................................................................. 32
`
`Cal. Code Regs. 27 § 25306(m) ................................................................. 32
`Federal Registers
`65 Fed. Reg. 24,586 (Apr. 21, 2000) ......................................................... 47
`
`69 Fed. Reg. 47,732 (Aug. 5, 2004) ............................................................ 5
`
`70 Fed. Reg. 40,251 (July 13, 2005) ............................................. 45, 47, 48
`
`71 Fed. Reg. 45,720 (Aug. 9, 2006) .................................................... 45, 48
`
`74 Fed. Reg. 28,616 (June 17, 2009) ........................................................ 53
`
`
`
`
`
`
`xi
`
`

`

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`
`ATSDR
`
`EPA
`
`ESA
`
`FIFRA
`
`IARC
`
`GLOSSARY
`
`U.S. Agency for Toxic Substances and Disease
`Registry
`
`
`
`
`
`
`
`Environmental Protection Agency
`
`Endangered Species Act
`
`Federal Insecticide, Fungicide, and Rodenticide
`Act
`
`World Health Organization’s International
`Agency for Research on Cancer
`
`Interim Decision
`
`EPA’s Interim Registration Review Decision for
`glyphosate
`
`
`
`
`
`
`
`
`
`NRDC
`
`ORD
`
`SAP
`
`
`
`Natural Resources Defense Council
`
`EPA’s Office of Research and Development
`
`Scientific Advisory Panel
`
`
`
`xii
`
`

`

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`
`INTRODUCTION
`
`In its Interim Registration Review Decision for glyphosate
`
`(“Interim Decision”), EPA reasonably concluded that glyphosate is not
`
`likely to be a human carcinogen and poses no human-health risks of
`
`concern. The record underlying these conclusions is robust, reflecting
`
`more than a decade of analysis and thorough review of the scientific
`
`literature. Petitioners respond to this record with a studied blindness,
`
`attempting to inflate the appearance of risk while disregarding the
`
`reams of evidence that rebut their arguments. Petitioners cannot
`
`overturn EPA’s expert scientific conclusions, which are entitled to the
`
`highest deference, merely by arguing that there is some evidence in the
`
`record that might support an alternative conclusion or closing their eyes
`
`to the record as a whole. That record supports EPA’s conclusions with
`
`well more than substantial evidence.1
`
`Petitioners also contend that EPA violated the Endangered
`
`Species Act (“ESA”) by not completing a consultation pursuant to
`
`
`1 EPA’s Interim Decision included other analysis, including in
`particular of ecological risks, but by separate motion filed
`simultaneously herewith, EPA is seeking voluntary remand without
`vacatur of that portion of its decision.
`
`1
`
`

`

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`
`Section 7(a)(2) “prior to registering glyphosate.” This claim fails on its
`
`face, as the Interim Decision did not register glyphosate. It is evident
`
`that the true aim of Petitioners’ ESA claim is not to compel consultation
`
`on the Interim Decision, but rather to take glyphosate off the market.
`
`To justify such relief, Petitioners mischaracterize the Interim Decision
`
`as a registration decision and the cause of all alleged effects of
`
`glyphosate. But because the Interim Decision is neither a registration
`
`decision nor the cause of the effects Petitioners complain of, their
`
`“failure to consult” claim fails. Petitioners do not show that the Interim
`
`Decision “may affect” ESA-listed species or critical habitats, which is
`
`the trigger for consultation. In fact, Petitioners defeat their own
`
`argument by contending that the Interim Decision fails to alter the
`
`status quo. Furthermore, EPA has already committed to complete a
`
`comprehensive, nationwide ESA consultation of the effects of glyphosate
`
`before it issues its final registration review decision. Ordering EPA to
`
`consult on the Interim Decision—or vacating it—would be
`
`counterproductive.
`
`To call Petitioners’ proposed remedy an overreach would be an
`
`understatement. Their request that the Court abruptly declare each of
`
`2
`
`

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`
`the more than five hundred glyphosate product registrations unlawful
`
`is contrary to FIFRA, which forbids automatic cancellation of product
`
`registrations as a result of the registration review process. It would
`
`also cause widespread disruption, as glyphosate is the most widely used
`
`herbicide in the United States, such that this remedy would be
`
`inappropriate even if it were lawful.
`
`The Court should deny the petitions for review.
`
`STATEMENT OF JURISDICTION
`
`The consolidated petitions for review of the Interim Decision were
`
`timely filed on March 20, 2020, “within 60 days after the entry of [the]
`
`order.” 7 U.S.C. § 136n(b).
`
`STATEMENT OF THE ISSUES
`
`(1) Have Petitioners carried their burden to show that EPA’s
`
`conclusion that glyphosate does not pose human-health risks of concern
`
`is not supported by substantial evidence, where they disregard key
`
`components of the record, EPA’s analysis, and governing regulations?
`
`(2) Have Petitioners shown that EPA breached a duty to
`
`complete ESA consultation on the Interim Decision, when that action
`
`did not register glyphosate or cause the effects of glyphosate, and
`
`3
`
`

`

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`
`Petitioners make no showing that the Interim Decision, itself, “may
`
`affect” any listed species or critical habitat?
`
`(3)
`
`Is Petitioners’ claim that EPA failed to complete ESA
`
`consultation prudentially moot, where EPA has committed to complete
`
`a comprehensive, nationwide consultation on glyphosate prior to issuing
`
`its final registration review decision, to begin by November 12, 2021,
`
`and consulting on the Interim Decision would likely delay that
`
`consultation?
`
`(4)
`
`Is vacatur of more than 500 glyphosate product registrations
`
`a lawful and appropriate remedy where FIFRA forbids automatic
`
`cancellation of such registrations as a result of the registration review
`
`process and such cancellation would cause profound disruption?
`
`PERTINENT STATUTES AND REGULATIONS
`
`The pertinent statutes and regulations not provided in Petitioners’
`
`briefs are set forth in the Addendum following this brief.
`
`4
`
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`Case: 20-70787, 05/18/2021, ID: 12116743, DktEntry: 80-1, Page 19 of 95
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`STATEMENT OF THE CASE
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`I.
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`Statutory and regulatory background.
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`A. Federal Insecticide, Fungicide, and Rodenticide
`Act (“FIFRA”).
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`FIFRA generally precludes the distribution or sale of any pesticide
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`unless it is “registered” by EPA. 7 U.S.C. § 136a(a); 40 C.F.R. pts. 152,
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`158. Entities that seek such a registration must provide EPA
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`information about the applicant, their specific pesticide product, and
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`the pesticide label. 7 U.S.C. § 136a(c). Once granted, a FIFRA
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`registration is a license conferred to the applicant that establishes the
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`terms and conditions under which the applicant’s specific pesticide
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`product may be lawfully sold, distributed, and used in the United
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`States. 7 U.S.C. §§ 136a(c)(1)(A)-(F), 136a(d)(1); see also Nathan
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`Kimmel, Inc. v. DowElanco, 275 F.3d 1199, 1204 (9th Cir. 2002); 69 Fed.
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`Reg. 47,732, 47,733 (Aug. 5, 2004).
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`EPA will register a pesticide if it determines that the pesticide
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`“will perform its intended function without unreasonable adverse effects
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`on the environment,” and “when used in accordance with widespread
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`and commonly recognized practice it will not generally cause
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`unreasonable adverse effects on the environment,” among other
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`5
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`Case: 20-70787, 05/18/2021, ID: 12116743, DktEntry: 80-1, Page 20 of 95
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`requirements. 7 U.S.C. § 136a(c)(5). FIFRA defines “unreasonable
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`adverse effects on the environment” to include “any unreasonable risk
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`to man or the environment, taking into account the economic, social,
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`and environmental costs and benefits of the use of any pesticide.” Id. §
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`136(bb). It is unlawful to use a pesticide “in a manner inconsistent with
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`its labeling.” Id. § 136j(a)(2)(G).
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`EPA must periodically review pesticide registrations. Id. §
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`136a(g); 40 C.F.R. § 155.40 et seq.2 A registration review reflects EPA’s
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`“determination whether a pesticide meets, or does not meet, the
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`standard for registration in FIFRA.” 40 C.F.R. § 155.57. EPA will
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`create a “registration review case” for one or more active ingredients in
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`a pesticide and all of the products containing such ingredients, establish
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`a docket for public participation, and provide an opportunity for
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`comment. Id. §§ 155.42, 155.50. It may “call in” data necessary to
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`conduct its review. See 7 U.S.C. §§ 136a(c)(2)(B), (g)(2); 40 C.F.R. §
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`155.48. EPA will assess changes since the pesticide’s last review and
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`2 EPA is currently reviewing roughly 1,140 pesticide active ingredients.
`See https://www.epa.gov/pesticide-reevaluation/registration-review-
`process.
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`6
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`Case: 20-70787, 05/18/2021, ID: 12116743, DktEntry: 80-1, Page 21 of 95
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`conduct new assessments as needed. 40 C.F.R. § 155.53. In the course
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`of a registration review, EPA may determine that certain label
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`restrictions are appropriate. See id. § 155.58(b)(2), (4).
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`EPA need not tackle the entirety of the registration review at
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`once, but rather may make an “interim registration review decision.”
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`Id. § 155.56. “Among other things, the interim registration review
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`decision may require new risk mitigation measures, impose interim risk
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`mitigation measures, identify data or information required to complete
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`the review, and include schedules for submitting the required data,
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`conducting the new risk assessment and completing the registration
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`review.” Id.
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`A FIFRA registration remains effective until EPA cancels it, which
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`is a statutorily defined administrative action subject to specific
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`safeguards. See 7 U.S.C. § 136d(b); 40 C.F.R. § 155.40; Reckitt
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`Benckiser Inc. v. EPA, 613 F.3d 1131, 1134 (D.C. Cir. 2010). If EPA
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`concludes that a pesticide product does not meet FIFRA’s standard,
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`cancellation is not automatic. Rather, EPA has discretion to initiate
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`cancellation proceedings. See 7 U.S.C. § 136d(b). To do so, EPA must
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`typically notify the Secretary of Agriculture, provide the Secretary an
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`7
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`Case: 20-70787, 05/18/2021, ID: 12116743, DktEntry: 80-1, Page 22 of 95
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`analysis of the impact of cancellation on the agricultural economy, and
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`afford the Secretary an opportunity to comment. Id. EPA must then
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`send the registrant notice of EPA’s intent to cancel the registration or to
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`hold a hearing on cancellation, and publish that notice. Id. If EPA
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`issues a notice of intent to cancel the registration (rather than a notice
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`of intent to hold a hearing), EPA may cancel the registration unless the
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`registrant corrects the defect EPA identified or “a person adversely
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`affected by the notice” requests a hearing. Id. If a hearing is requested
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`or EPA has issued a notice of intent to hold a hearing, the final decision
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`on cancellation will occur only after completion of an administrative
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`adjudicatory hearing. See id. § 136d(b), (d); 40 C.F.R. pt. 164. In
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`making a decision, EPA “shall” consider restricting a pesticide’s use or
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`uses as an alternative to cancellation, taking into account the impact of
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`its decision on agriculture. 7 U.S.C. § 136d(b).
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`This rule—that cancellation of a FIFRA registration cannot be
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`automatic—extends to registration review. Congress provided that
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`pesticide registrations shall not be cancelled “as a result of the
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`registration review process unless [EPA] follows the procedures and
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`8
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`Case: 20-70787, 05/18/2021, ID: 12116743, DktEntry: 80-1, Page 23 of 95
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`substantive requirements” for cancellation set forth in Section 136d. Id.
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`§ 136a(g)(1)(A)(v).
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`B. Endangered Species Act (“ESA”).
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`ESA Section 7(a)(2) directs each federal agency to insure that “any
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`action authorized, funded, or carried out by such agency . . . is not likely
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`to jeopardize the continued existence of” a listed species or destroy or
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`adversely modify designated critical habitat. 16 U.S.C. § 1536(a)(2). To
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`facilitate compliance with those mandates, the ESA’s implementing
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`regulations outline a process whereby federal “action agencies” consult
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`with the appropriate expert “consulting agency” (either the National
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`Marine Fisheries Service or the U.S. Fish & Wildlife Service or both,
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`depending on the species involved) to, among other things, analyze the
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`potential impacts of a proposed action on listed species and designated
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`critical habitat. 50 C.F.R. §§ 402.13(a), 402.14(b)(1).
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`Consultation is required whenever a proposed federal action “may
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`affect” listed species or critical habitat. Id. § 402.14(a). Agency “action”
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`and “effects of the action” are defined terms under the ESA. Id. §
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`402.02. If the action will

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