throbber
Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 1 of 115
`
`Nos. 19-72109 & 19-72280
`
`
`
`
`UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`
`
`
`
`
`
`
`
`CENTER FOR FOOD SAFETY, et al.,
`Petitioners,
`
`v.
`
`U.S. ENVIRONMENTAL PROTECTION AGENCY, et al.,
`Respondents.
`
`
`
`
`
`
`On Petition for Review of Final Agency Action of the
`United States Environmental Protection Agency
`
`
`
`
`BRIEF OF THE ENVIRONMENTAL PROTECTION AGENCY
`
`
`
`
`JEAN E. WILLIAMS
`Acting Assistant Attorney General
`BRUCE GELBER
`Deputy Assistant Attorney General
`Meghan E. Greenfield
`Briena Strippoli
`Attorneys
`Environment and Natural Resources
`Division
`U.S. Department of Justice
`150 M Street, N.E.
`Washington, D.C. 20002
`(202) 514-2795
`Meghan.Greenfield@usdoj.gov
`
`Of Counsel:
`Amber Aranda
`U.S. Environmental Protection
`Agency
`
`
`
`
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 2 of 115
`
`
`TABLE OF CONTENTS
`
`GLOSSARY ............................................................................................ viii
`
`INTRODUCTION ...................................................................................... 1
`
`STATEMENT OF THE ISSUES ............................................................... 4
`
`PERTINENT STATUTES AND REGULATIONS ................................... 4
`
`STATEMENT OF THE CASE .................................................................. 5
`
`1.
`
`2.
`
`Federal Insecticide, Fungicide, and
`Rodenticide Act .............................................................. 5
`
`Endangered Species Act ................................................. 7
`
`B. Procedural History ................................................................ 11
`
`1.
`
`2.
`
`3.
`
`4.
`
`2013 Registration ......................................................... 11
`
`2016 Registrations and 2019 Registration
`Amendments ................................................................ 12
`
`Record Supporting 2019 Registration
`Amendments ................................................................ 14
`
`Petitions for Review and Procedural History .............. 15
`
`SUMMARY OF THE ARGUMENT ........................................................ 16
`
`STANDARD OF REVIEW....................................................................... 19
`
`ARGUMENT ........................................................................................... 20
`
`I.
`
`Remand Is Proper to Allow EPA to Remedy the ESA
`Defect and Further Explain Its FIFRA Rationale......................... 20
`
`i
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 3 of 115
`
`A. EPA’s acknowledgment of error, along with the
`intervening decision in National Family Farm
`Coalition v. EPA, provides a proper basis to
`remand this action. ............................................................... 20
`
`B. EPA’s remand request is timely and made in good
`faith. ...................................................................................... 23
`
`II. Vacatur of the Registration Amendments Is Not
`Required or Appropriate During the Pendency of the
`Remand. .......................................................................................... 27
`
`A. The ESA error and EPA’s intent to elucidate its
`FIFRA rationale are not such serious deficiencies
`that vacatur is required. ....................................................... 29
`
`1.
`
`2.
`
`EPA took into account ecological impacts in
`the registration amendments, and so the
`ESA error does not weigh heavily in favor of
`vacatur. ......................................................................... 29
`
`There is no serious deficiency in the FIFRA
`analysis. ........................................................................ 34
`
`3. No procedural flaw warrants vacatur. ........................ 36
`
`B. Vacatur of the 2019 registration amendments
`would be inequitable because it would cause
`environmental and economic harm. ..................................... 40
`
`1.
`
`Vacatur could cause environmental harm. ................. 41
`
`a.
`
`The FIFRA record supports the
`conclusion that sulfoxaflor is less toxic
`than the most widely used
`alternatives. ........................................................ 41
`
`ii
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 4 of 115
`
`b.
`
`The claimed errors with the FIFRA
`analysis do not undermine EPA’s
`analysis of the ecological effects of the
`pesticide. .............................................................. 48
`
`2.
`
`Vacatur would cause economic hardship. .................... 57
`
`CONCLUSION ........................................................................................ 61
`
`
`
`iii
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 5 of 115
`
`TABLE OF AUTHORITIES
`
`Cases
`
`Allied–Signal, Inc. v. U.S. Nuclear Regulatory Comm’n,
`988 F.2d 146 (D.C. Cir. 1993) .......................... 19, 28, 32, 33, 34, 39, 40
`
`
`ASARCO, Inc. v. Occupational Safety & Health Admin.,
`746 F.2d 483 (9th Cir. 1984) ................................................................ 19
`
`
`B.J. Alan Co. v. ICC,
`897 F.2d 561 (D.C. Cir. 1990) .............................................................. 21
`
`
`Cal. Cmtys. Against Toxics v. EPA,
`688 F.3d 989 (9th Cir. 2012) ........... 18, 19, 21, 22, 23, 27, 28, 32, 39, 40
`
`
`Ctr. for Biological Diversity v. EPA,
`861 F.3d 174 (D.C. Cir. 2017) ................................ 24, 28, 29, 30, 32, 47
`
`
`Ethyl Corp. v. Browner,
`989 F.2d 522 (D.C. Cir. 1993) ........................................................ 20, 21
`
`
`Heartland Reg’l Med. Ctr. v. Sebelius,
`566 F.3d 193 (D.C. Cir. 2009) .............................................................. 33
`
`
`Idaho Farm Bureau Fed’n v. Babbitt,
`58 F.3d 1392 (9th Cir. 1995) ................................................................ 39
`
`
`Lands Council v. McNair,
`537 F.3d 981 (9th Cir. 2008), rev’d on other grounds by
` Winter v. NRDC, 555 U.S. 7 (2008) ..................................................... 35
`
`Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co.,
`463 U.S. 29 (1983) ................................................................................ 20
`
`
`Nat’l Family Farm Coal. v. EPA,
`960 F.3d 1120 (9th Cir. 2020) ........................................ 2, 24, 25, 33, 52
`
`
`
`iv
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 6 of 115
`
`Nat’l Family Farm Coal. v. EPA,
`966 F.3d 893 (9th Cir. 2020) ................................................ 5, 30, 31, 34
`
`
`Nat’l Fuel Gas Supply Corp. v. FERC,
`899 F.2d 1244 (D.C. Cir. 1990) ............................................................ 33
`
`
`Pac. Rivers Council v. Thomas,
`30 F.3d 1050 (9th Cir. 1994) .................................................................. 8
`
`
`Pollinator Stewardship Council v. EPA,
`806 F.3d 520 (9th Cir. 2015) ................. 11, 12, 28, 31, 33, 36, 37, 44, 51
`
`
`SKF USA, Inc. v. United States,
`254 F.3d 1022 (Fed. Cir. 2001) ................................................ 20, 21, 33
`
`
`Standing Rock Sioux Tribe v. U.S. Army Corps of Eng’rs,
`985 F.3d 1032 (D.C. Cir. 2021) ...................................................... 32, 40
`
`
`United States v. Alpine Land & Reservoir Co.,
`887 F.2d 207 (9th Cir. 1989) ................................................................ 19
`
`
`Wash. Toxics Coal. v. EPA,
`413 F.3d 1024 (9th Cir. 2005), abrogated on other grounds by
`Cottonwood Envtl. Law Ctr. v. U.S. Forest Serv.,
` 789 F.3d 1075 (9th Cir. 2015) ................................................................ 9
`Statutes
`
` U.S.C. § 136(bb) .......................................................................... 6, 25, 26
`
` 7
`
` 7
`
` U.S.C. § 136(l) ....................................................................................... 24
`
` U.S.C. § 136(p) ........................................................................................ 5
`
` 7
`
` 7
`
` U.S.C. § 136a(a) ...................................................................................... 5
`
` U.S.C. § 136a(c)(1) .................................................................................. 5
`
`
`
`v
`
` 7
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 7 of 115
`
`7 U.S.C. § 136a(c)(4) .............................................. 5, 13, 27, 35, 36, 37, 38
`
` U.S.C. § 136a(c)(5) ............................................................................ 6, 11
`
` U.S.C. § 136a(c)(11) .............................................................................. 10
`
` 7
`
` 7
`
` 7
`
` U.S.C. § 136j(a)(2)(G) ............................................................................. 6
`
` U.S.C. § 136n(b) ...................................................................................... 3
`
`
`16 U.S.C. § 1531(b) .................................................................................... 7
`
`16 U.S.C. § 1536 ........................................................................................ 7
`
`16 U.S.C. § 1536(a)(2) .......................................................................... 7, 23
`
`16 U.S.C. § 1536(b)(3) ................................................................................ 8
`
`Pub. L. No. 113-79, § 10013, 128 Stat. 649 (2014) .................................... 9
`
`Pub. L. No. 115-334, 132 Stat. 4490 (2018) ............................................ 10
`
`Code of Federal Regulations
`
`40 C.F.R. § 152.102 ........................................................................... 35, 38
`
`40 C.F.R. § 158.45(a) ............................................................................... 49
`
`50 C.F.R. pt. 402 ........................................................................................ 7
`
`50 C.F.R. § 402.12 ..................................................................................... 8
`
`50 C.F.R. § 402.13 ............................................................................... 8, 24
`
`50 C.F.R. § 402.13(a) ................................................................................. 8
`
`50 C.F.R. § 402.14 ........................................................................... 7, 8, 24
`
`vi
`
` 7
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 8 of 115
`
`
`50 C.F.R. § 402.14(a) ............................................................................... 24
`
`50 C.F.R. § 402.14(b)(1) ............................................................................. 8
`
`Federal Registers
`
`75 Fed. Reg. 80,490 (Dec. 20, 2010) .................................................. 13, 36
`
`79 Fed. Reg. 22,963 (Apr. 25, 2014) .................................................. 14, 36
`
`83 Fed. Reg. 51,678 (Oct. 12, 2018) ................................................... 14, 36
`
`Other
`
`Charles H. Koch Jr., Administrative Law & Practice
` § 8:31, at 187 (3d ed. 2010) .................................................................. 20
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`vii
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 9 of 115
`
`
`
`GLOSSARY
`Endangered Species Act ....................................................................... ESA
`
`U.S. Environmental Protection Agency .............................................. EPA
`
`Federal Insecticide, Fungicide, and Rodenticide Act ...................... FIFRA
`
`U.S. Department of Agriculture ....................................................... USDA
`
`viii
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 10 of 115
`
`INTRODUCTION
`
`
`
`Sulfoxaflor is a highly selective pesticide that targets a range of
`
`piercing and sucking insects. It has become an indispensable form of
`
`pest control for growers as numerous crops have become resistant to
`
`older pesticides. Further, sulfoxaflor is generally less toxic, has lower
`
`application rates and requires fewer applications than many older,
`
`widely used pesticides. It also dissipates quickly in pollen and nectar,
`
`thereby posing less risk to pollinator species than other widely-used
`
`alternatives.
`
`Petitioners here challenge the U.S. Environmental Protection
`
`Agency’s (EPA) 2019 issuance of amendments to the registration of
`
`sulfoxaflor under the Federal Insecticide, Fungicide, and Rodenticide
`
`Act (FIFRA).1 One of the consolidated petitions for review also advances
`
`claims under the Endangered Species Act (ESA). EPA recognizes that
`
`the Agency failed to comply with the ESA’s requirement of issuing an
`
`effects determination prior to issuing the 2019 registration amendments
`
`
`1 The actions challenged in this case are amendments to the
`registrations that were first issued in 2019. See July 12, 2019 PRIA
`Label Amendment – Closer SG, PSCER000031; July 12, 2019 PRIA
`Label Amendment – Transform WG, PSCER000111. The earlier
`registrations of sulfoxaflor in 2016 are not at issue in this case.
`
`
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 11 of 115
`
`for sulfoxaflor. EPA further recognizes that the Agency’s rationale
`
`describing why the amendments satisfy the FIFRA standard could be
`
`more robust, particularly in light of the recent decision in Nat’l Family
`
`Farm Coal. v. EPA, 960 F.3d 1120, 1127 (9th Cir. 2020). Accordingly,
`
`EPA respectfully requests that this Court remand the challenged
`
`registration amendments to the Agency to allow EPA to correct the ESA
`
`error and also to provide additional detail on why the FIFRA standard
`
`is satisfied on this record. It is well established that remand is proper in
`
`the circumstances here—namely, where EPA acknowledges a legal
`
`error and also where an intervening court decision requires further
`
`examination by the Agency.
`
`EPA further seeks that the remand be granted without vacatur.
`
`The ESA error may be remedied through further Agency action on
`
`remand, and EPA can—at the same time—provide additional
`
`explanation as to why the registration amendments satisfy the FIFRA
`
`standard. Vacatur would be inequitable because it would render sale
`
`and distribution of sulfoxaflor for the uses permitted in the 2019
`
`amendments unlawful under FIFRA, thereby removing a pesticide with
`
`reduced toxicity from the market and very likely increasing the use of
`2
`
`
`
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 12 of 115
`
`older, generally more toxic alternatives. In fact, increased use of these
`
`alternatives could pose greater risk to the very species that Petitioners
`
`seek to protect as well as to other species and humans. This
`
`environmental harm, along with the clear adverse economic
`
`consequences that would result from vacatur, establishes that remand
`
`without vacatur is proper.
`
`STATEMENT OF JURISDICTION
`
`
`
`This court has jurisdiction over the consolidated petitions for
`
`review under 7 U.S.C. § 136n(b), which provides for judicial review in
`
`the courts of appeals “of any order issued by the Administrator
`
`following a public hearing.” The 2019 actions challenged here amend
`
`the 2016 registrations. Decision Mem. Supporting Registration Decision
`
`for New Uses of the Active Ingredient Sulfoxaflor (July 12, 2019) (July
`
`2019 Decision), EPA-HQ-OPP-2010-0889-0570, 1-PSCER-000001-
`
`000030. EPA issued the 2016 registration amendments after notice and
`
`comment proceedings. See EPA, Registration Decision for Sulfoxaflor for
`
`Use on Agricultural Crops, Ornamentals and Turf (Oct. 14, 2016) (2016
`
`Registration), EPA-HQ-OPP-2010-0889-0563, 4-PSCER-000687-000697.
`
`
`
`3
`
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 13 of 115
`
`STATEMENT OF THE ISSUES
`1. Whether remand of the challenged agency actions is proper where
`
`EPA has acknowledged a legal error under the Endangered
`
`Species Act (ESA), and wishes to provide further explanation for
`
`its actions under the Federal Insecticide, Fungicide, and
`
`Rodenticide Act (FIFRA) after an intervening court decision
`
`interpreting the requirements of that statute.
`
`2. Whether the Court should exercise its equitable discretion and
`
`decline to vacate the challenged pesticide registration actions
`
`where EPA can remedy the ESA error and elucidate its FIFRA
`
`rationale on remand, and where vacating the actions could cause
`
`environmental and economic harm by taking a valuable tool away
`
`from farmers and resulting in the use of more toxic pesticides.
`
`PERTINENT STATUTES AND REGULATIONS
`
`
`
`The pertinent statutes and regulations not included as part of the
`
`Petitioners’ briefs are reproduced in an appendix to this brief.
`
`
`
`4
`
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 14 of 115
`
`STATEMENT OF THE CASE
`
`A. Legal Background
`
`1. Federal Insecticide, Fungicide, and
`Rodenticide Act
`
`FIFRA generally precludes the distribution or sale of any pesticide
`
`unless it is “registered” by EPA. 7 U.S.C. § 136a(a). The registration
`
`process begins through submission of a “statement,” which includes,
`
`among other things, the name and complete “formula of the pesticide.”
`
`Id. § 136a(c)(1). EPA then provides “a notice of each application for
`
`registration of any pesticide if it contains any new active ingredient or if
`
`it would entail a changed use pattern” and allows opportunity for
`
`comments. Id. § 136a(c)(4).
`
`EPA issues a license, referred to as a “registration,” for each
`
`specific pesticide product allowed to be marketed. Id. at § 136a(a); see
`
`also Nat’l Family Farm Coal. v. EPA, 966 F.3d 893, 912 (9th Cir. 2020)
`
`(same). “The terms and conditions on the license include exactly what
`
`product can be sold, the specific packaging it must be sold in, and
`
`labeling that contains instructions on proper use.” Id. (citing 7 U.S.C.
`
`§ 136(p)). The Act directs that EPA “shall register a pesticide” if the
`
`Agency determines that:
`
`
`
`5
`
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 15 of 115
`
`(A) its composition is such as to warrant the proposed claims
`for it;
`
`(B) its labeling and other material required to be submitted
`comply with the requirements of this subchapter;
`
`(C) it will perform its intended function without
`unreasonable adverse effects on the environment; and
`
`(D) when used in accordance with widespread and commonly
`recognized practice it will not generally cause unreasonable
`adverse effects on the environment.
`
`7 U.S.C. § 136a(c)(5).
`
`To evaluate whether an application to amend an existing
`
`registration should be granted, EPA evaluates whether the requested
`
`amendment, e.g., a proposed use, is likely to cause unreasonable
`
`adverse effects. Relevant here, Congress expressly directs EPA to
`
`balance benefits and costs. Thus, “unreasonable adverse effects on the
`
`environment” include “any unreasonable risk to man or the
`
`environment, taking into account the economic, social, and
`
`environmental costs and benefits of the use of any pesticide.” Id.
`
`§ 136(bb).
`
`It is unlawful to use a pesticide “in a manner inconsistent with its
`
`labeling.” Id. § 136j(a)(2)(G). A pesticide product’s labeling is therefore
`
`integral to EPA’s registration decision and is the primary means of
`6
`
`
`
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 16 of 115
`
`accomplishing FIFRA’s mandate to prevent unreasonable adverse
`
`effects.
`
`2. Endangered Species Act
`Congress enacted the ESA “to provide a means whereby the
`
`ecosystems upon which endangered species and threatened species
`
`depend may be conserved,” and “to provide a program for the
`
`conservation of such endangered species and threatened species.” 16
`
`U.S.C. § 1531(b). ESA section 7 directs each federal agency to insure, in
`
`consultation with the U.S. Fish and Wildlife Service and/or National
`
`Marine Fisheries Service (collectively, the Services), that “any action
`
`authorized, funded, or carried out by such agency . . . is not likely to
`
`jeopardize the continued existence of” any listed species or destroy or
`
`adversely modify designated critical habitat. Id. § 1536(a)(2).
`
`Section 7 and its implementing regulations delineate a process for
`
`determining the biological impacts of a proposed action known as
`
`section 7 consultation. 16 U.S.C. § 1536; 50 C.F.R. pt. 402. Through this
`
`process, the agency proposing the relevant action (referred to as the
`
`action agency) must determine whether its action “may affect” a listed
`
`species or its designated critical habitat. 50 C.F.R. § 402.14. If the
`7
`
`
`
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 17 of 115
`
`action agency determines that the action will have “no effect” on listed
`
`species or critical habitat, it need not “consult” under section 7. See 50
`
`C.F.R. § 402.12; Pac. Rivers Council v. Thomas, 30 F.3d 1050, 1054 n.8
`
`(9th Cir. 1994). If, however, the agency determines that the action “may
`
`affect” listed species or critical habitat, the action agency must pursue
`
`either informal or formal consultation with one or both of the Services.
`
`50 C.F.R. §§ 402.13-402.14.
`
`Formal consultation is required unless the action agency
`
`determines, with the Services’ written concurrence, that the proposed
`
`action is “not likely to adversely affect” a listed species or critical
`
`habitat. 50 C.F.R. §§ 402.13(a), 402.14(b)(1). If formal consultation is
`
`required, then one or both of the Services must prepare a biological
`
`opinion stating whether the proposed action is likely to “jeopardize the
`
`continued existence of” any listed species or destroy or adversely modify
`
`designated critical habitat. 16 U.S.C. § 1536(b)(3); 50 C.F.R. § 402.14.
`
`B. Historical Background
`FIFRA predates the ESA, and many hundreds of pesticides that
`
`have been approved and are available for use have not undergone ESA
`
`review—namely, without EPA first undertaking an effects
`8
`
`
`
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 18 of 115
`
`determination or, as appropriate, initiating consultation under the ESA.
`
`See Wash. Toxics Coal. v. EPA, 413 F.3d 1024 (9th Cir. 2005), abrogated
`
`on other grounds by Cottonwood Envtl. Law Ctr. v. U.S. Forest Serv.,
`
`789 F.3d 1075 (9th Cir. 2015). EPA has acknowledged its duty to make
`
`an effects determination and, if required, consult under ESA section 7
`
`prior to issuing a registration for a pesticide. See id. In recent years,
`
`EPA has worked with the Services, along with help from the National
`
`Academy of Sciences, to address the backlog and remedy noncompliance
`
`by creating a framework for pesticide consultation. See Jan Matuszko’s
`
`Declaration in Support of Answering Brief (EPA’s Second Decl.), ¶¶ 12-
`
`13.2 Congress is aware of this dialogue and has requested that EPA
`
`report on consultation progress and streamline integration of ESA and
`
`FIFRA procedures. Pub. L. No. 113-79, § 10013, 128 Stat. 649 (2014).
`
`To this end, EPA began several “pilot” Biological Evaluations
`
`using the methods identified by the National Academy of Sciences as a
`
`
`2 Jan Matuszko’s first declaration was filed in support of EPA’s motion
`to remand. See EPA’s First Decl., Doc. Id. No. 11871851. Ms.
`Matuszko’s second declaration provides an updated assessment of the
`reasonable amount of time EPA projects it will require to make an
`effects determination for sulfoxaflor. See EPA’s Second Decl. ¶ 5.
`9
`
`
`
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 19 of 115
`
`first step towards implementing the Academy’s recommendations. See
`
`EPA’s Second Decl. ¶¶ 13-14. In doing so, EPA has been allocating most
`
`resources to the review of older, generally more toxic pesticides, rather
`
`than to the first-time registration of new, generally less toxic
`
`ingredients. See EPA’s Second Decl. ¶¶ 14, 19.
`
`Subsequently, EPA, the Department of the Interior, and the
`
`Department of Commerce signed a memorandum of agreement
`
`establishing an interagency working group to include these and other
`
`federal agencies tasked with providing recommendations to the
`
`agencies’ leadership on improving the ESA consultation process for
`
`pesticides. See EPA’s Second Decl. ¶ 13. The intent of the interagency
`
`working group is to improve the consultation process for pesticide
`
`registration and registration review. Id. On December 20, 2018, the
`
`Agriculture Improvement Act of 2018 (2018 Farm Bill) (Pub. L. No. 115-
`
`334, 132 Stat. 4490) was signed into law, codifying the interagency
`
`working group and the memorandum of agreement. As required under
`
`section 10115 of the 2018 Farm Bill and FIFRA, 7 U.S.C. § 136a(c)(11),
`
`the interagency working group report was delivered to Congress in
`
`December 2019, and an update was provided in June 2020. Id.
`10
`
`
`
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 20 of 115
`
`B. Procedural History
`2013 Registration
`1.
`Sulfoxaflor is an insecticide that targets a broad range of piercing
`
`and sucking insects including aphids, plant bugs, whiteflies,
`
`planthoppers, mealybugs, and scales. July 2019 Decision at 13,
`
`1-PSCER-000013. In 2010, Intervenor Corteva Agriscience LLC
`
`(Corteva)3 submitted registration applications to EPA for three
`
`pesticide products that contain sulfoxaflor as their active ingredient. In
`
`May 2013, EPA granted unconditional registration of these products
`
`under FIFRA, 7 U.S.C. § 136a(c)(5), with certain mitigating measures to
`
`protect pollinator species like bees. See EPA, Registration of the New
`
`Active Ingredient Sulfoxaflor for Use on Multiple Commodities,
`
`Turfgrass and Ornamentals (May 2013), 4-PSCER-000757. These
`
`registrations were challenged on FIFRA grounds by a number of
`
`petitioners. See Pollinator Stewardship Council v. EPA, 806 F.3d 520
`
`(9th Cir. 2015). No party challenged the registrations under the ESA at
`
`
`3 Corteva was formerly known as Dow AgroSciences LLC. For ease of
`reference, the intervenor is referred to as “Corteva” throughout this
`brief.
`
`
`
`11
`
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 21 of 115
`
`that juncture—rather, challenges were solely brought under FIFRA. See
`
`id.
`
`In 2015, the Court granted the petitions for review on the ground
`
`that EPA lacked sufficient data on the impacts of sulfoxaflor on bee
`
`populations. Id. at 531. Because of this, the Court held that EPA’s
`
`decision was not supported by substantial evidence under FIFRA. Id.
`
`The Court then vacated the registration because, on that record,
`
`“leaving the EPA’s registration of sulfoxaflor in place risks more
`
`potential environmental harm than vacating it.” Id. at 532.
`
`2.
`
`2016 Registrations and 2019 Registration
`Amendments
`
`After the vacatur of the registration in 2015, EPA reevaluated the
`
`sulfoxaflor application to take into account the errors identified by the
`
`Pollinator Stewardship Council court. In 2016, EPA granted
`
`unconditional registrations of three pesticide products containing
`
`sulfoxaflor for use on specified crops, turf, and ornamentals. See 2016
`
`Decision, 4-PSCER-000687 (discussing issuance of registrations for
`
`Sulfoxaflor Technical (Registration No. 62719-631) and two end use
`
`
`
`12
`
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 22 of 115
`
`products, Transform WG (Registration No. 62719-625) and Closer SC
`
`(Registration No. 62719-623)). These registrations were not challenged.
`
`Then, in July 2019, EPA granted unconditional amendments
`
`under FIFRA section 3(c)(5) to those same registrations. These
`
`amendments granted the following new uses: alfalfa, corn, cacao, grains
`
`(millet, oats), pineapple, sorghum, teff, teosinte, tree plantations, citrus,
`
`cotton, cucurbits, soybeans, and strawberry. July 2019 Decision,
`
`1-PSCER-000001. Finally, the 2019 actions removed certain restrictions
`
`that were included in the October 2016 registrations. Id.
`
`Applications for each of the uses that were approved in the 2019
`
`registration amendments were publicly noticed under FIFRA section
`
`3(c)(4), 7 U.S.C. § 136a(c)(4). See July 2019 Decision, 1-PSCER-000001
`
`(approving uses on alfalfa, corn, cacao, grains (millet and oats),
`
`pineapple, sorghum, teff, teosinte, tree plantations, citrus, cotton,
`
`cucurbits, soybeans, and strawberry). Specifically, the 2010 notice
`
`advised the public of the application for use on citrus, cotton, cucurbits,
`
`soybeans, and strawberry. Notice of Receipt of Several Pesticide
`
`Petitions Filed for Residues of Pesticide Chemicals in or on Various
`
`Commodities, 75 Fed. Reg. 80,490 (Dec. 22, 2010). The 2014 notice
`13
`
`
`
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 23 of 115
`
`advised the public of the application for use on alfalfa, cacao, corn, grain
`
`(millet and oats), pineapple, sorghum, teff, and teosinte. See Pesticide
`
`Product Registration; Receipt of Applications for New Uses, 79 Fed.
`
`Reg. 22,963 (Apr. 25, 2014). And, in 2018, a notice advised the public on
`
`the application for use on tree plantations. See Pesticide Product
`
`Registration; Receipt of Applications for New Uses, 83 Fed. Reg. 51,678
`
`(Oct. 12, 2018). Each of these notices provided an opportunity for public
`
`comment.
`
`3. Record Supporting 2019 Registration
`Amendments
`
`As part of the 2019 registration amendment decisions, EPA
`
`prepared an assessment of the ecological risks from the proposed
`
`amendments to the registrations. See Sulfoxaflor: Ecological Risk
`
`Assessment for Section 3 Registration for Various Proposed New Uses
`
`(July 10, 2019) (Risk Assessment), EPA-HQ-OPP-2010-0889-0566,
`
`3-PSCER-000354. EPA also considered the impacts to pollinators based
`
`on existing and newly submitted data. See July 2019 Decision at 7-9,
`
`1-PSCER-000007-000009. Finally, EPA prepared a benefits analysis of
`
`the amendments to help determine whether the proposed uses of the
`
`
`
`14
`
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 24 of 115
`
`pesticide pose unreasonable adverse effects to the environment and
`
`concluded that they did not. See Benefits for New Uses of Sulfoxaflor on
`
`Alfalfa, Avocado, Citrus, Corn, Cotton, Cucurbits, Fruiting Vegetables,
`
`Pineapple, Pome Fruit (Pre-bloom), Rice, Sorghum, Soybean,
`
`Strawberry, Ornamental and Home Fruit Trees (Mar. 7, 2019) (Benefits
`
`Assessment), EPA-HQ-OPP-2010-0889-0569, PSCER000641-000686;
`
`July 2019 Decision at 1-22, 1-PSCER-000010-000022 (discussing
`
`findings). In short, EPA concluded that sulfoxaflor provides numerous
`
`benefits against hard to control pests and is less acutely toxic generally,
`
`including to beneficial insects like honeybees, than the most widely
`
`used alternatives. See id.
`
`4. Petitions for Review and Procedural
`History
`
`
`
`Shortly after the 2019 amendments were issued, the petitioners
`
`filed petitions for review challenging these amendments. Petitioners
`
`Center for Biological Diversity and Center for Food Safety challenged
`
`the registration amendments on ESA and FIFRA grounds. See Pet. for
`
`Review, Case No. 19-72109, Doc. Id. No. 11403618. Petitioners
`
`Pollinator Stewardship Council, American Beekeeping Federation, and
`
`
`
`15
`
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 25 of 115
`
`Jeffrey Andersen challenged the actions on FIFRA grounds alone. See
`
`Pet. for Review, Case No. 19-72280, Doc. Id. No. 11423191. The
`
`petitions for review have been consolidated. See Nov. 4, 2019 Order,
`
`Doc. Id. No. 11487539. The registrant, Corteva, intervened in support of
`
`EPA. See Oct. 3, 2019 Order, Doc. Id. No. 11453342.
`
`
`
`In October of 2020, EPA filed a motion for remand of the
`
`registration amendments without vacatur. Mot. to Remand, Doc. Id. No.
`
`11871851. EPA explained that it did not comply with the ESA’s
`
`requirements before issuing the registration amendments. Id. at 11-12.
`
`EPA further argued that remand without vacatur was proper because
`
`EPA could correct the legal error on remand, and vacatur of the
`
`amendments could cause adverse environmental and economic
`
`consequences. Id. at 15-21. Petitioners opposed EPA’s motion. Id. at 2.
`
`The Court denied EPA’s motion on January 12, 2021 and ordered
`
`merits briefing. Doc. Id. No. 11960653.
`
`SUMMARY OF THE ARGUMENT
`
`
`
`This Court should grant remand without vacatur of the 2019
`
`registration amendments that are challenged here. As a threshold
`
`matter, EPA easily satisfies the standard for voluntary remand. The
`16
`
`
`
`
`

`

`Case: 19-72109, 04/15/2021, ID: 12074930, DktEntry: 87, Page 26 of 115
`
`Agency has acknowledged a legal error—namely, that it must make an
`
`effects determination and take other action as appropriate under the
`
`ESA. EPA further r

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket