throbber
Case: 19-72109, 05/03/2021, ID: 12100713, DktEntry: 109, Page 1 of 149
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`REDACTED
`No. 19-72109, 19-72280
`
`IN THE
`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,
`
`
`and
`
`CORTEVA AGRISCIENCE LLC,
` Respondent-Intervenor.
`
`
`
`
`
`ON PETITION FOR REVIEW FROM THE UNITED STATES
`ENVIRONMENTAL PROTECTION AGENCY
`
`
`
`
`
`BRIEF OF INTERVENOR
`CORTEVA AGRISCIENCE LLC
`
`
`
`
`
`
`
`Kirsten L. Nathanson
`Amanda Shafer Berman
`David Y. Chung
`Amy Symonds
`CROWELL & MORING LLP
`1001 Pennsylvania Avenue, NW
`Washington, DC 20004
`(202) 624-2887
`knathanson@crowell.com
`
`Counsel for Intervenor Corteva
`Agriscience LLC
`
`
`
`
`
`
`
`
`
`

`

`C a s e :
`
`
` 1 9 - 7 2 1 0 9 ,
`
` 0 5 / 0 3 / 2 0 2 1 ,
`
`
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`I D :
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` 1 2 1 0 0 7 1 3 ,
`
`CORPORATE DISCLOSURE STATEMENT
`Pursuant to Federal Rule of Appellate Procedure 26,1, Respondent-Intervenor
`
`Corteva Agriscience LLC (“Corteva”) respectfully submits the following Corporate
`
`Disclosure Statement.
`
`Corteva is a Delaware limited liability company. Corteva is 100% owned by
`
`Mycogen LLC, Centen Ag LLC (“Centen”), and DDP AgroSciences US DCOMCO,
`
`Inc. (“DDP”). Centen and DDP are wholly owned by Pioneer Hi-Bred International,
`
`Inc., which is wholly owned by E. I. du Pont de Nemours and Company (“EID”), a
`
`publicly traded company. EID is wholly owned by Corteva, Inc., a publicly traded
`
`company. No other corporation holds a 10% or greater ownership interest in Corteva.
`
`Dated: May 3, 2021
`
`Respectfully submitted,
`
`
`
`
`
`
`
`
`
`/s/ Kirsten L. Nathanson
`Kirsten L. Nathanson
`Amanda Shafer Berman
`David Y. Chung
`Amy Symonds
`CROWELL & MORING LLP
`1001 Pennsylvania Avenue, NW
`Washington, DC 20004
`(202) 624-2887
`knathanson@crowell.com
`Counsel
`for
`Intervenor Corteva
`Agriscience LLC
`
`i
`
`
`
`

`

`Case: 19-72109, 05/03/2021, ID: 12100713, DktEntry: 109, Page 3 of 149
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`
`
`
`TABLE OF CONTENTS
`
`Page
`
`
`CORPORATE DISCLOSURE STATEMENT ......................................................... i 
`INTRODUCTION .................................................................................................... 1 
`STATEMENT OF JURISDICTION......................................................................... 3 
`PERTINENT STATUTES AND REGULATIONS ................................................. 3 
`STATEMENT OF THE CASE ................................................................................. 4 
`A. 
`The 2013 Registration and the Pollinator I decision. .......................... 4 
`B. 
`EPA Re-Registers Sulfoxaflor in 2016. ............................................... 5 
`C. 
`Corteva Submits More Data to Support Additional Uses. ................... 5 
`D. 
`The 2019 Registration Amendments. ................................................... 7 
`E. 
`Petitioners’ Challenge to the 2019 Registration Amendments. ........... 9 
`SUMMARY OF ARGUMENT .............................................................................. 10 
`ARGUMENT .......................................................................................................... 12 
`I. 
`The Registration Amendments Must be Assessed Under FIFRA’s
`Substantial Evidence Standard, with Deference to EPA’s Expert
`Assessment of the Record Data. ................................................................... 12 
`Substantial Evidence Supports EPA’s Conclusion that the Registration
`Amendments Will Not Have Unreasonable Adverse Effects. ..................... 15 
`A. 
`Substantial evidence supports EPA’s conclusion that expanding
`sulfoxaflor usage is environmentally beneficial. ............................... 16 
`There is substantial evidence that sulfoxaflor displaces the use
`of older, less effective pesticides. ....................................................... 22 
`Petitioners’ other attacks on the Registration Amendments fall
`short. ................................................................................................... 29 
`
`II. 
`
`B. 
`
`C. 
`
`ii
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`
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`

`

`2. 
`
`3. 
`
`B. 
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`C a s e :
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` 1 9 - 7 2 1 0 9 ,
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` 0 5 / 0 3 / 2 0 2 1 ,
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`I D :
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` 1 2 1 0 0 7 1 3 ,
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`1. 
`
`Petitioners’ argument that EPA failed to assess risk to
`non-honey bees is misleading and baseless. ............................ 29 
`EPA considered economic and social impacts from
`sulfoxaflor use. ......................................................................... 30 
`EPA’s decision to reconsider certain mitigation measures
`was sound. ................................................................................ 33 
`III.  Vacatur is Not an Appropriate Remedy Because It Would Eliminate
`Sulfoxaflor’s Environmental Benefit and Cause Economic Damage. ......... 35 
`A.  Vacatur is unwarranted because EPA extensively evaluated the
`ecological effects of the Registration Amendments. ......................... 35 
`Remand without vacatur will be environmentally beneficial and
`avoid economic disruption. ................................................................ 43 
`1. 
`Remand without vacatur will be environmentally
`beneficial. ................................................................................. 44 
`Remand without vacatur will avoid disruption to farmers. ..... 53 
`2. 
`CONCLUSION ....................................................................................................... 59 
`
`
`
`
`
`
`iii
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`

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`Case: 19-72109, 05/03/2021, ID: 12100713, DktEntry: 109, Page 5 of 149
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`All. for Wild Rockies v. Marten,
`789 F. App’x 583 (9th Cir. 2020) ....................................................................... 43
`Allied-Signal, Inc. v. U.S. Nuclear Regul. Comm’n,
`988 F.2d 146 (D.C. Cir. 1993) .......................................................... 35, 36, 42, 43
`ASARCO, Inc. v. OSHA,
`746 F.2d 483 (9th Cir. 1984) ........................................................................ 15, 16
`Biestek v. Berryhill,
`139 S. Ct. 1148 (2019) .................................................................................. 13, 14
`Cal. Cmtys. Against Toxics v. EPA,
`688 F.3d 989 (9th Cir. 2012) .......................................................................passim
`California Communities Against Toxics v. EPA,
`688 F.3d 174 (9th Cir. 2012) .............................................................................. 59
`City of Tacoma, Washington v. FERC,
`460 F.3d 53 (D.C. Cir. 2006) .............................................................................. 38
`Consolo v. Fed. Mar. Comm’n,
`383 U.S. 607 (1966) ............................................................................................ 13
`Ctr. for Biological Diversity v. EPA,
`861 F.3d 174 (D.C. Cir. 2017) ................................................................ 36, 44, 45
`Ctr. for Biological Diversity v. Esper,
`958 F.3d 895 (9th Cir. 2020) .............................................................................. 14
`EME Homer City Generation, L.P. v. EPA,
`795 F.3d 118 (D.C. Cir. 2015) ............................................................................ 43
`Idaho Farm Bureau Fed’n v. Babbitt,
`58 F.3d 1392 (9th Cir. 1995) .............................................................................. 43
`Nat. Res. Def. Council, Inc. v. U.S. Dep’t of Interior,
`275 F. Supp. 2d 1136 (C.D. Cal. 2002) .............................................................. 44
`iv
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`

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`Case: 19-72109, 05/03/2021, ID: 12100713, DktEntry: 109, Page 6 of 149
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`
`Nat. Res. Def. Council v. EPA,
`857 F.3d 1030 (9th Cir. 2017) ................................................................ 13, 14, 28
`Nat’l Parks Conservation Ass’n v. Semonite,
`422 F. Supp. 3d 92 (D.D.C. 2019) ...................................................................... 42
`National Family Farm Coalition v. EPA,
`960 F.3d 1120 (9th Cir. 2020) .................................................................. 2, 31, 32
`National Family Farm Coalition v. EPA,
`966 F.3d 893 (9th Cir. 2020) .......................................................................passim
`Nw. Food Processors Ass’n v. Reilly,
`886 F.2d 1075 (9th Cir. 1989) ............................................................................ 21
`Oglala Sioux Tribe v. U.S. Nuclear Regul. Comm’n,
`896 F.3d 520 (D.C. Cir. 2018) ...................................................................... 42, 44
`Pollinator Stewardship Council v. EPA,
`806 F.3d 520 (9th Cir. 2015) .......................................................................passim
`Standing Rock Sioux Tribe v. U.S. Army Corps of Eng’rs,
`985 F.3d 1032 (D.C. Cir. 2021) .................................................................... 41, 42
`United States v. Alpine Land and Reservoir Co.,
`887 F.2d 207 (9th Cir. 1989) .............................................................................. 29
`W. Oil & Gas Ass’n v. EPA,
`633 F.2d 803 (9th Cir. 1980) .............................................................................. 44
`Statutes
`7 U.S.C. § 136n(b) ................................................................................................... 12
`Regulations
`40 C.F.R. § 158.630 ................................................................................................. 21
`
`v
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`

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`Case: 19-72109, 05/03/2021, ID: 12100713, DktEntry: 109, Page 7 of 149
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`
`Other Authorities
`EPA, Reduced Risk and Organophosphate Alternative Decisions for
`Conventional Pesticides, available at
`https://www.epa.gov/pesticide-registration/reduced-risk-and-
`organophosphate-alternative-decisions-conventional (last accessed
`Apr. 30, 2021) ............................................................................................... 26, 27
`Insecticide Resistance Action Committee, Interactive MoA
`Classification, available at https://irac-online.org/modes-of-action/
`(last visited Mar. 7, 2021) ................................................................................... 17
`U.S. EPA, Overview of the Ecological Risk Assessment Process in the
`Office of Pesticide Programs, U.S. Environmental Protection
`Agency (Jan. 23, 2004) ........................................................................................ 38
`
`vi
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`INTRODUCTION
`Petitioners’ briefs are high on histrionics but low on science. Corteva deeply
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`appreciates the importance of bees to U.S. food supply. Indeed, Corteva’s success—
`
`and the success of the farmers it serves—depends on providing products that prevent
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`pests from destroying crops, while safeguarding beneficial insects, including bees.
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`That is exactly what sulfoxaflor does: it pinpoints piercing, sucking, and sap-feeding
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`insects, while posing minimal risk to other species (including bees) and the
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`environment when applied in accordance with the label instructions applicable to the
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`uses of sulfoxaflor approved by Respondent EPA in 2019.
`
`EPA’s decision to approve the 2019 Registration Amendments is supported
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`by substantial record evidence, as required by FIFRA.1 In direct response to this
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`Court’s 2015 decision in Pollinator Stewardship Council v. EPA, 806 F.3d 520, 532–
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`33 (9th Cir. 2015) (“Pollinator I”), Corteva submitted, and EPA carefully reviewed
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`and relied on, extensive data showing that sulfoxaflor products are effective in
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`preventing damage from piercing and sucking insects in a broad range of crops,
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`while causing no unreasonable adverse effects on bees, any other species, or the
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`environment more broadly. That data included “Tier II” studies specific to the effects
`
`of sulfoxaflor on bees, including colony feeding and tunnel studies, which
`
`
`1 The Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. §§ 136, et seq.
`1
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`demonstrated that sulfoxaflor poses very little (if any) risk to bees and bee colonies.
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`Further, EPA’s analysis confirmed that sulfoxaflor is a more effective alternative to
`
`certain older pesticides that: are more acutely toxic to bees; must be applied more
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`frequently and in greater quantities than sulfoxaflor; and persist much longer in the
`
`environment. See 1-PSCER-010, 1-PSCER-016-022.
`
`Petitioners’ contrary arguments are based on speculation and hyperbole,
`
`supported by snippets from the record taken out of context. For example, Petitioners
`
`repeatedly cite a reference to the “potential” for colony-level impacts. See 1-PSCER-
`
`008. But Petitioners omit critical context: that such impacts were “indicat[ed] . . .
`
`conservatively assuming that bees feed exclusively on the treated crop.” 1-PSCER-
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`009. Thus, EPA was clear that it was referring to potential impacts from exceptional,
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`prolonged exposure. Petitioners conveniently ignore the robust record evidence
`
`marshaled by EPA to support its ultimate conclusion that, based on the Tier II studies
`
`and additional data submitted by Corteva, as well as the agency’s own analyses,
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`there will be no unreasonable adverse impacts on bee colonies in actuality.
`
`In its brief, EPA offers to provide additional explanation on certain of the
`
`FIFRA issues raised by Petitioners while completing its Endangered Species Act
`
`(“ESA”) analysis. See Dkt. Entry 87 at 2. While Corteva agrees that such an offer
`
`makes sense in light of the intervening decision in National Family Farm Coalition
`
`v. EPA, 960 F.3d 1120, 1127 (9th Cir. 2020), wherein this Court addressed certain
`
`2
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`FIFRA issues in more detail than prior cases, that does not mean that the Registration
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`Amendments are not supported by substantial evidence. EPA reasonably concluded
`
`that the Tier I and II studies, coupled with data showing that sulfoxaflor is less toxic
`
`and persistent in the environment than the alternatives, collectively showed that the
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`sulfoxaflor uses at issue pose no unreasonable adverse environmental effects.
`
`Finally, while EPA did not undertake an ESA analysis before issuing the
`
`Registration Amendments, that procedural misstep—which the Agency has
`
`committed to rectifying by mid-2022—does not justify vacatur. Not only would that
`
`harm growers who depend on sulfoxaflor to manage pests that can destroy their
`
`crops, it eliminates sulfoxaflor’s environmental benefit. Growers would revert to
`
`applying less effective and more environmentally persistent pesticides, which EPA’s
`
`analysis plainly shows pose more risk to pollinators and endangered species. Given
`
`those negative environmental and economic impacts, this is a classic case for remand
`
`without vacatur while EPA meets its obligations under the ESA.
`
`STATEMENT OF JURISDICTION
`Corteva agrees with Respondent EPA’s jurisdictional statement.
`
`STATEMENT OF THE ISSUES
`Corteva agrees with EPA’s Issues Statement.
`
`PERTINENT STATUTES AND REGULATIONS
`The pertinent statutes and regulations are included in the Addendums to
`
`
`
`Petitioners’ and EPA’s briefs.
`
`3
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`STATEMENT OF THE CASE
`A. The 2013 Registration and the Pollinator I decision.
`In May 2013, EPA unconditionally registered sulfoxaflor for a wide range of
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`crops, including leafy and fruiting vegetables, citrus, cotton, cucurbits, root
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`vegetables, berries, pome fruits, soybeans, stone fruits, and tree nuts. 4-PSCER-642.
`
`The Pollinator Stewardship Council (“PSC”), among others, petitioned for review,
`
`alleging that the data on which EPA relied were inadequate.
`
`In November 2015, this Court held that the 2013 Registration Decision was
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`not supported by substantial evidence. Pollinator I, 806 F.3d at 531. It vacated and
`
`remanded “for the EPA to obtain further studies and data regarding the effects of
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`sulfoxaflor on bees.” Id. at 533. Specifically, the Court found that the Tier II studies
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`were flawed because four of the six studies tested sulfoxaflor at application rates that
`
`were much lower than EPA’s maximum proposed application rate. Id. at 529. The
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`Court also found that the existing studies provided inconclusive or insufficient data
`
`to evaluate the effects of sulfoxaflor on brood development and long-term colony
`
`strength. Id. The Court further explained that the two studies providing the best data
`
`on brood development had insufficient controls and low application rates. Id. at 530.
`
`Studies on colony strength suffered from the same limitations, and were measured
`
`for too short a time period—between 7 and 17 days after application. Id. Finally, the
`
`Court asserted that EPA needed more residue studies to understand the nature and
`
`4
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`

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`magnitude of sulfoxaflor residue on pollinator-attractive crops. Id.
`
`B.
`EPA Re-Registers Sulfoxaflor in 2016.
`In 2016, Corteva2 submitted to EPA a substantially amended sulfoxaflor label,
`
`designed to eliminate exposure to bees. See 4-PSCER-689. EPA granted the
`
`amended registration, which limited the application of sulfoxaflor to post-bloom for
`
`crops that may be attractive to pollinators, and altogether prohibited application to
`
`crops grown for seed. Id. The registration also mandated a 12-foot down-wind, on-
`
`field aerial buffer. 4-PSCER-696. Indeterminate blooming crops that had been
`
`originally registered in 2013, such as citrus, cotton, cucurbits, soybeans, and
`
`strawberries, were excluded from the 2016 Registration. Id. EPA determined that
`
`limiting the use of sulfoxaflor to certain crops and restricting the timing of
`
`applications would result in “essentially no exposure to bees on the treated field.”
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`4-PSCER-717. The 2016 registration decision was not challenged, and so the uses
`
`approved therein are not at issue here. However, that action did not cover many
`
`important crops, prompting farmers to seek and EPA to grant a number of Section
`
`18 “Emergency Exemptions” permitting additional short-term uses.
`
`C. Corteva Submits More Data to Support Additional Uses.
`Because the 2016 registration did not cover certain important crops, Corteva
`
`
`2 Until recently, Corteva was known as Dow AgroSciences LLC (“DAS”), see Dkt.
`Entry No. 77. Thus, throughout the Administrative Record, the court will see
`references to and submissions by DAS.
`
`5
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`thereafter requested that EPA amend it to permit expanded sulfoxaflor usage. In
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`support of that request, Corteva spent several million dollars conducting extensive
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`additional testing and studies to evaluate whether sulfoxaflor causes unreasonable
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`adverse effects on the environment, including bees and other pollinators. Decl. of
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`James D. Thomas ¶ 10, Doc. ID # 11437265 (ECF No. 8-2). In addition to several
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`new Tier I studies, Corteva submitted three new Tier II semi-field (tunnel) studies
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`and two colony feeding studies, each of which evaluated long-term effects on honey
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`bee colonies. 1-PSCER-008. Corteva also provided EPA with 14 additional Tier II
`
`field residue studies for assessing oral exposure. Id.
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`EPA used the Tier II tunnel studies to assess risk to honey bees from contact
`
`and oral exposure, and subsequently determined that “there was no impact on long
`
`term hive health, including hive strength, brood indices, brood strength, or food
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`stores prior to overwintering up to the maximum rate of .09 lb. [of active ingredient
`
`per acre].” Id. The colony feeding studies assessed risk to bees 10–42 days after oral
`
`exposure and revealed that there would be a low potential for colony-level risks to
`
`honey bees in many crops, such as canola, corn, cotton, pome fruit, and sorghum.
`
`Id. Although EPA found a “potential” for “colony-level risk” in the remaining crops,
`
`that statement was predicated on the highly conservative assumption that bees would
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`feed exclusively on the treated crop. 1-PSCER-009.
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`6
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`Finally, the Tier II residue studies analyzed sulfoxaflor residues in pollen and
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`nectar for multiple crops, demonstrating that “the short persistence of sulfoxaflor in
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`pollen and nectar . . . [was] not expected to sequentially accumulate in pollen and
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`nectar . . . based on [application interval restrictions].” 1-PSCER-022. The studies
`
`showed that, even when sprayed directly on foraging honey bees, sulfoxaflor had no
`
`long-term effects on colonies, and its impacts dissipated within three days. Id.
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`D. The 2019 Registration Amendments.
`After reviewing the full Tier I suite of studies, nine Tier II tunnel studies, two
`
`Tier II colony feeding studies, and 16 Tier II field residue studies, EPA amended
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`Corteva’s registration of sulfoxaflor on July 12, 2019. The 2019 Registration
`
`Amendments (i) permitted sulfoxaflor’s use on alfalfa, corn cacao, grains, pineapple,
`
`sorghum, teff, teosinte, and tree plantations; and (ii) added citrus, cotton, cucurbits,
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`soybeans and strawberries back to the Transform WG, Closer SC, and Sulfoxaflor
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`Technical labels. 1-PSCER-023.
`
`In approving the 2019 Registration Amendments, EPA concluded that
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`sulfoxaflor is not only more effective against certain target pests than existing
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`pesticides, but that earlier pesticides “present a greater degree of risk to listed species
`
`than most new chemistries, including sulfoxaflor.” 1-PSCER-010. EPA also
`
`explained that, because of its “unique chemistry and lack of cross-resistance to
`
`7
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`neonicotinoids and other insecticides,” sulfoxaflor is a valuable tool for managing
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`pesticide resistance. 1-PSCER-018.
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`Sulfoxaflor’s value is also evidenced by the numerous growers who applied
`
`for a Section 18 emergency exemption after the 2015 vacatur of sulfoxaflor
`
`registrations went into effect. 1-PSCER-013. In granting such emergency
`
`exemptions, EPA determined that registered alternatives had lost their efficacy, or
`
`that there were no registered alternatives against, certain pests including the invasive
`
`sugarcane aphid. Id. Importantly, EPA found that sulfoxaflor is highly selective to
`
`pests and less disruptive to beneficial arthropods. 1-PSCER-016. By registering
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`sulfoxaflor for use on various crops, EPA determined that there would be less impact
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`on beneficial predatory insects, which would in turn reduce the need for pesticide
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`treatment for later-season damaging pests. Id.
`
`Finally, EPA determined that sulfoxaflor has a better ecological and human
`
`health profile compared to registered alternatives. 1-PSCER-019. Sulfoxaflor’s
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`toxicity against non-target organisms is significantly lower than the toxicity of the
`
`six most commonly used pesticides currently registered for sulfoxaflor’s proposed
`
`uses. Id. Sulfoxaflor is also unique because it presents no acute or chronic risk to
`
`aquatic animals or plants. Id. EPA also concluded that sulfoxaflor “has less of an
`
`impact on bees than its main alternatives.” 1-PSCER-021. Importantly, despite being
`
`in use since 2012, either under Section 18 emergency authorizations or under Section
`
`8
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`3 registrations, sulfoxaflor has never been found to have adversely affected
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`pollinators in the field. 1-PSCER-009.3
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`Based on the robust studies submitted by Corteva, EPA found that the benefits
`
`of registering sulfoxaflor far outweighed the minimal risks. 1-PSCER-023. And
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`those minimal risks were mitigated by EPA’s label restrictions for certain crops; for
`
`example, EPA prohibited application to pome and stone fruit crops during bloom.
`
`1-PSCER-029.
`
`E.
`Petitioners’ Challenge to the 2019 Registration Amendments.
`On August 20, 2019, Petitioners Center for Biological Diversity and Center
`
`for Food Safety petitioned for review of EPA’s 2019 Registration Decision (the
`
`“CFS Petition” or “CFS Br.”). Case No. 19-72109, Dkt. Entry No. 1. Petitioners
`
`Pollinator Stewardship Council and American Beekeeping Federation filed their
`
`Petition for Review on September 16, 2019. Case No. 19-72280, Dkt. Entry No. 1.
`
`EPA moved to remand the Registration Amendments without vacatur on
`
`October, 26, 2020. Dkt. Entry No. 51. The Court denied EPA’s motion without
`
`discussion (Dkt. Entry No. 51) and the case proceeded to merits briefing.
`
`
`3 One incident concerning bees was reported to EPA in early 2014, but EPA
`concluded it was unlikely that the bees had been exposed to sulfoxaflor, given that
`the incident had occurred in mid-2013, when sulfoxaflor was still undergoing state-
`specific registration and “had not yet entered channels of trade,” and several other
`pesticides as well as “unnamed chemicals” were also involved. 1-PSCER-009.
`9
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`Case: 19-72109, 05/03/2021, ID: 12100713, DktEntry: 109, Page 17 of 149
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`SUMMARY OF ARGUMENT
`EPA’s conclusion that amending its 2016 registration of sulfoxaflor to permit
`
`additional uses would not have unreasonable adverse environmental effects was well
`
`supported by the record before the agency, including the many new “Tier II” studies
`
`submitted by Corteva and thoroughly reviewed by EPA. FIFRA’s substantial
`
`evidence standard does not require complete certainty or perfect data, and EPA’s
`
`assessment of whether additional data is needed and what the data before it shows is
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`entitled to deference—particularly in a case like this, where the agency must deploy
`
`its scientific expertise and considerable experience with the FIFRA program to
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`decide whether, and with what mitigation measures, to register certain new uses of
`
`a previously approved pesticide.
`
`The sufficiency of the data before EPA here is not a close question. The
`
`numerous new studies of the effects of sulfoxaflor (including on bees), combined
`
`with EPA’s comparative analysis of sulfoxaflor’s attributes vis-à-vis the most
`
`commonly used alternative pesticides, provide strong support for EPA’s conclusion
`
`that expanded usage of sulfoxaflor would not have adverse environmental effects,
`
`but rather would be environmentally beneficial. Petitioners would have this Court
`
`second-guess EPA’s analysis, questioning whether additional studies should have
`
`been required (beyond the 27 Tier II studies and full suite of Tier I data considered
`
`by the agency), and arguing that EPA should have compared sulfoxaflor to a broader
`
`10
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`
`
`

`

`Case: 19-72109, 05/03/2021, ID: 12100713, DktEntry: 109, Page 18 of 149
`
`
`set of alternatives (even though many of those Petitioners point to are barely used).
`
`But the relevant question is not whether Petitioners, or even the Court, might have
`
`made different choices in analyzing the data or come to a different conclusion.
`
`Rather, it is whether, as a whole, the evidence before the agency is substantial
`
`enough to support EPA’s decision.
`
`That is plainly the case here. The data amassed by EPA on sulfoxaflor and its
`
`effects, including on bees, well exceeds the data available in regard to most
`
`alternatives. That data (including many Tier II studies specific to bees) clearly
`
`demonstrates that sulfoxaflor poses minimal risks to bees both short and long-term.
`
`It also shows that sulfoxaflor is both less toxic and less persistent in the environment
`
`than the commonly used alternatives. Petitioners themselves urged EPA to regard
`
`that last factor—persistence—as critically important, and EPA did so: it compared
`
`“RT25” dissipation rates, and found that sulfoxaflor dissipates faster (in less than 3
`
`hours, as compared to days in some cases) than every commonly used alternative.
`
`Petitioners’ insistence that a pesticide shown to be less toxic; less persistent in the
`
`environment; and more effective, such that it can be applied less often and in lesser
`
`quantities, should not be permitted to be used in lieu of more environmentally
`
`persistent and less effective alternatives is unmoored from both science and reason.
`
`Finally, while a remand of the 2019 Registration Amendments is appropriate
`
`to allow EPA to complete its ESA analysis for sulfoxaflor, vacatur is not warranted.
`
`11
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`
`
`

`

`Case: 19-72109, 05/03/2021, ID: 12100713, DktEntry: 109, Page 19 of 149
`
`
`EPA’s FIFRA analysis provides strong support for its conclusion that expanded
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`sulfoxaflor usage would in fact be environmentally beneficial, as it will replace
`
`older, more persistent pesticides—that have to be used more frequently because they
`
`are also less effective—in growers’ integrated pest management (“IPM”) programs.
`
`This is therefore a classic case for remand without vacatur, which would be
`
`environmentally detrimental, as well as economically harmful to growers relying on
`
`sulfoxaflor to provide the protection from pests that older, less effective alternatives
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`previously used cannot. Vacatur is also particularly inappropriate given that EPA
`
`has committed to completing its ESA analysis by next spring, and has offered to
`
`provide additional explanation in regard to certain of the FIFRA issues raised by
`
`Petitioners during that time as well. Growers should not be penalized—to the
`
`detriment of the environment and species, including bees—where EPA can complete
`
`its analysis in the near term, and (given its prior fulsome assessment of
`
`environmental effects) is highly likely to reaffirm that sulfoxaflor will not adversely
`
`affect either endangered species or the environment.
`
`I.
`
`ARGUMENT
`The Registration Amendments Must be Assessed Under FIFRA’s
`Substantial Evidence Standard, with Deference to EPA’s Expert
`Assessment of the Record Data.
`
`This Court must uphold EPA’s registration decision “if it is supported by
`
`substantial evidence when considered on the record as a whole.” 7 U.S.C. § 136n(b).
`
`12
`
`
`
`

`

`Case: 19-72109, 05/03/2021, ID: 12100713, DktEntry: 109, Page 20 of 149
`
`
`Substantial evidence “means—and means only—such relevant evidence as a
`
`reasonable mind might accept as adequate to support a conclusion.” Biestek v.
`
`Berryhill, 139 S. Ct. 1148, 1154 (2019) (citation and internal quotation marks
`
`omitted). It is more than a mere scintilla, but less than a preponderance. Nat. Res.
`
`Def. Council v. EPA, 857 F.3d 1030, 1036 (9th Cir. 2017) (“Nanosilver II”). Even if
`
`two inconsistent conclusions could be drawn from the evidence, that does not mean
`
`that the agency’s decision is not supported by substantial evidence. Id.
`
`Here, as discussed below, EPA’s decision is supported by substantial
`
`evidence—including the numerous Tier II studies conducted by Corteva and
`
`submitted to EPA to address the specific data gaps identified by the Court in in
`
`Pollinator I. At the very least, EPA’s conclusion that sulfoxaflor will not cause
`
`unreasonable adverse effects on the environment is one a “reasonable mind might
`
`accept” given the ample data supporting that conclusion. Biestek, 139 S. Ct. at 1154
`
`(citation omitted).
`
`Acknowledging the deferential approach to substantive evidence review, the
`
`Supreme Court stated that the standard “frees the reviewing courts of the time
`
`consuming and difficult task of weighing the evidence” and “gives proper respect to
`
`the expertise of the administrative tribunal . . . .” Consolo v. Fed. Mar. Comm’n, 383
`
`U.S. 607, 620 (1966). Accordingly, this Court should defer to EPA’s selection and
`
`evaluation of the data and studies used to support its registration decision, as the
`
`13
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`
`
`

`

`Case: 19-72109, 05/03/2021, ID: 12100713, DktEntry: 109, Page 21 of 149
`
`
`Agency has deployed its considerable scientific expertise and longstanding
`
`familiarity with the technical issues raised in this case. See Nanosilver II, 857 F.3d
`
`at 1036 (“When . . . the agency is making predictions, within its area of special
`
`expertise, at the frontiers of science . . . a reviewing court must generally be at its
`
`most deferential.”) (citation and internal quotation marks omitted).
`
`On substantial evidence review, EPA need not present evidence to support an
`
`outcome with certainty. See id. at 1038–39; Biestek, 139 S. Ct. at 1154 (“[W]hatever
`
`the meaning of ‘substantial’ in other contexts, the threshold for such evidentiary
`
`sufficiency is not high.”). And as this Court explained in National Family Farm
`
`Coalition v. EPA, 966 F.3d 893, 919 (9th Cir. 2020), the fact that a study is limited
`
`in some res

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