Case: 19-72280, 06/04/2021, ID: 12133543, DktEntry: 124-1, Page 1 of 38
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`
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`Nos. 19-72109 & 19-72280
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`
`IN THE UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`
`
`POLLINATOR STEWARDSHIP COUNCIL, AMERICAN BEEKEEPING
`FEDERATION, and JEFFERY S. ANDERSON,
`
`Petitioners,
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`v.
`
`UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, et al.,
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`Respondents,
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`and
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`CORTEVA AGRISCIENCE LLC,
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`Respondent-Intervenor.
`
`
`On Petition for Review of an Order of the
`United States Environmental Protection Agency
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`
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`PETITIONERS’ REPLY BRIEF
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`
`
`
`
`
`SURBHI SARANG
`Earthjustice
`48 Wall Street, 19th Floor
`New York, NY 10005
`T: 212.845.7376
`E: ssarang@earthjustice.org
`
`
`GREGORY C. LOARIE
`Earthjustice
`50 California Street, Suite 500
`San Francisco, CA 94111
`T: 415.217.2000
`E: gloarie@earthjustice.org
`
`
`Counsel for Petitioners
`
`

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`TABLE OF CONTENTS
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`INTRODUCTION ..................................................................................................... 1
`ARGUMENT ............................................................................................................. 4
`I.
`The Court Should Address the Merits of Beekeepers’ FIFRA Claims Before
`Remanding EPA’s Registration Decision. ....................................................... 4
`A.
`EPA Does Not Intend to Reconsider Its Registration Decision. ........... 4
`B.
`Remanding EPA’s Decision Without Reaching the Merits Would
`Unduly Prejudice Beekeepers. ............................................................... 6
`No Intervening Change in Law Warrants Remanding EPA’s Decision
`Without Reaching the Merits. ................................................................ 8
`This Is Not an Exceptional Case Warranting Remand Without Vacatur. ..... 10
`A.
`EPA Committed Many Serious Violations of Law. ............................ 10
`1.
`EPA Still Lacks Sufficient Data to Conduct the Required
`Assessment of Risk to Bees. ..................................................... 10
`EPA Lacks Information Necessary to Assess the Cost of
`Registering Sulfoxaflor’s New Uses. ........................................ 16
`EPA Failed to Provide the Requisite Public Notice and
`Opportunity for Comment. ........................................................ 18
`EPA Violated the “Heart of the ESA.” ..................................... 20
`4.
`Leaving EPA’s Decision in Place During Remand Would Cause
`Significant Environmental Harm, and Vacating It Will Not. .............. 21
`1.
`Honey Bee Populations Are More Precarious than Ever. ......... 22
`2.
`There Is No Basis for EPA’s Speculation that Vacatur May
`Cause Growers to Use Even More Harmful Insecticides. ........ 24
`a.
`EPA Lacks Sufficient Data to Assert Sulfoxaflor Is
`Better for Bees than the Alternatives It Identifies. ......... 24
`
`C.
`
`II.
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`2.
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`3.
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`B.
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`ii
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`b.
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`Vacatur Is Unlikely to Affect Overall Use of the
`Alternative Insecticides EPA Identifies. ......................... 26
`Vacatur Will Not Cause Significant Economic Disruption. ............... 27
`C.
`CONCLUSION ........................................................................................................ 30
`FORM 8 ................................................................................................................... 31
`CERTIFICATE OF SERVICE ................................................................................ 32
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`iii
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`TABLE OF AUTHORITIES
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`Cases
`Alsea Valley All. v. Dep’t of Com.,
`358 F.3d 1181 (9th Cir. 2004) ............................................................................ 10
`Am. Great Lakes Ports Ass’n v. Schultz,
`962 F.3d 510 (D.C. Cir. 2020) ............................................................................ 28
`Cottonwood Envtl. Law Ctr. v. U.S. Forest Serv.,
`789 F.3d 1075 (9th Cir. 2015) ...................................................................... 27, 28
`Ctr. for Biological Diversity v. EPA,
`861 F.3d 174 (D.C. Cir. 2017) ............................................................................ 21
`Ethyl Corp. v. Browner,
`989 F.2d 522 (D.C. Cir. 1993) .............................................................................. 5
`Humane Soc. v. Locke,
`626 F.3d 1040 (9th Cir. 2010) .............................................................................. 4
`Idaho Farm Bureau Fed’n v. Babbitt,
`58 F.3d 1392 (9th Cir. 1995) .............................................................................. 21
`Karuk Tribe of California v. U.S. Forest Serv.,
`681 F.3d 1006 (9th Cir. 2012) ............................................................................ 20
`League of United Latin Am. Citizens v. Regan,
`996 F.3d 673 (9th Cir. 2021) .......................................................................... 8, 26
`Limnia v. Dep’t of Energy,
`857 F.3d 379 (D.C. Cir. 2017) .............................................................................. 5
`Love v. Thomas,
`858 F.2d 1347 (9th Cir. 1988) ............................................................................ 17
`In re Nat. Res. Def. Council v. EPA,
`956 F.3d 1134 (9th Cir. 2020) .............................................................................. 8
`Nat’l Family Farm Coal. v. EPA,
`960 F.3d 1120 (9th Cir. 2020) .............................................................. 3, 9, 16, 17
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`iv
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`Nat’l Family Farm Coal. v. EPA,
`966 F.3d 893 (9th Cir. 2020) .............................................................................. 18
`Nat’l Fuel Gas Supply Corp. v. Fed. Energy Reg. Comm’n,
`899 F.2d 1244 ....................................................................................................... 9
`Natural Res. Def. Council v. EPA,
`676 F. Supp. 2d 307 (S.D.N.Y. 2009) ................................................................ 18
`Natural Res. Def. Council v. EPA,
`735 F.3d 873 (9th Cir. 2013) .............................................................................. 12
`Pollinator Stewardship Council v. EPA,
`806 F.3d 520 (9th Cir. 2015) .......................................................................passim
`Sierra Forest Legacy v. Sherman,
`646 F.3d 1161 (9th Cir. 2011) ............................................................................ 21
`Skagit Cty. Pub. Hosp. Dist. No. 2 v. Shalala,
`80 F.3d 379 (9th Cir. 1996) .................................................................................. 4
`Standing Rock Sioux Tribe v. Army Corps of Engineers,
`985 F.3d 1032 (D.C. Cir. 2021) .............................................................. 10, 18, 20
`Thomas v. Peterson,
`753 F.2d 754 (9th Cir. 1985) .............................................................................. 20
`United Farm Workers v. EPA,
`592 F.3d 1080 (9th Cir. 2010) .............................................................................. 8
`United States v. Houser,
`804 F.2d 565 (9th Cir. 1986) ................................................................................ 2
`Util. Solid Waste Activities Grp. v. EPA,
`901 F.3d 414 (D.C. Cir. 2018) .............................................................................. 6
`Statutes
`7 U.S.C. 136n ......................................................................................................... 4, 7
`7 U.S.C. § 136(bb) ..................................................................................................... 3
`7 U.S.C. § 136a(c)(4) ......................................................................................... 18, 19
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`v
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`7 U.S.C. § 136p ........................................................................................................ 28
`Regulations
`40 C.F.R. § 158.630 ................................................................................................. 11
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`vi
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`INTRODUCTION
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`Beekeepers brought this case because EPA violated the Federal Insecticide,
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`Fungicide, and Rodenticide Act (FIFRA) in three fundamental ways when it
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`approved sulfoxaflor for use on bee-attractive crops before and during bloom.
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`First, as in Pollinator Stewardship Council v. EPA, 806 F.3d 520, 532 (9th Cir.
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`2015) (Pollinator I), EPA lacked sufficient scientific data to conduct the required
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`assessment of sulfoxaflor’s risk to bees. Second, EPA lacked the economic and
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`agricultural information necessary to assess the cost of placing bees at additional
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`risk during a worsening pollinator crisis. Third, EPA failed to provide the requisite
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`public notice and opportunity for comment.
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`
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`EPA’s answering brief asks the Court to remand the registration decision at
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`issue without reaching these serious violations of FIFRA. EPA requests a remand
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`not to obtain additional data, solicit public comment, or reconsider its decision.
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`Instead, EPA seeks a remand so it can (1) comply with a requirement of the
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`Endangered Species Act (ESA) the agency previously elected to ignore and (2)
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`“explain more clearly” the rationale for its FIFRA decision. EPA commits to no
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`timeline for completing these tasks on remand, nor does EPA confirm its remand
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`will culminate in a superseding decision that will be subject to future review under
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`FIFRA. In the meantime, EPA asks the Court to leave the disputed registration
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`decision in place so sulfoxaflor’s new uses can continue indefinitely.
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`1
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`A motions panel of this Court properly rejected an earlier request by EPA
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`for a remand without vacatur in these consolidated cases. See Jan. 12, 2021 Order
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`(DktEntry 67). EPA’s veiled attempt to evade judicial review is no more
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`persuasive the second time around, and “a merits panel does not lightly overturn a
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`decision made by a motions panel during the course of the same appeal.” United
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`States v. Houser, 804 F.2d 565, 568 (9th Cir. 1986). Beekeepers ask the Court to
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`rule on the merits of their claims and vacate the decision at issue before remanding
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`to EPA for further administrative proceedings.
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`There are three compelling reasons for the Court to decide the merits of
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`Beekeepers’ claims before remanding EPA’s decision. First, EPA has made clear
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`it has no plans to reconsider its decision. Neither belated compliance with the ESA
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`nor post-hoc rationalizations will address the violations described in Beekeepers’
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`opening brief, redress Beekeepers’ injuries, or obviate the need for judicial review
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`of Beekeepers’ claims.
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`Second, remanding this case without reaching the merits would prejudice
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`Beekeepers, because whether the equities favor vacatur depends in part on the
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`merits of Beekeepers’ claims. Moreover, EPA’s indefinite remand may never
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`culminate in another opportunity for judicial review of Beekeepers’ claims.
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`Third, there has been no intervening change in law to warrant EPA’s
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`proposed remand. EPA understood its obligations under the ESA when it
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`2
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`registered sulfoxaflor’s new uses, and the agency made a strategic decision to
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`violate the ESA at that time. EPA also knew FIFRA’s “unreasonable risk”
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`standard requires it to consider the “costs and benefits of the use of any pesticide.”
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`7 U.S.C. § 136(bb). This Court’s opinion in Nat’l Family Farm Coal. v. EPA, 960
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`F.3d 1120 (9th Cir. 2020), did not change the law and does not warrant EPA’s
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`proposed remand.
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`There are equally compelling reasons for the Court to vacate EPA’s decision
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`before remanding. EPA committed multiple, serious violations of law when it
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`registered sulfoxaflor’s new uses. Addressing those violations of law will require
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`EPA to gather additional data and solicit public comments, at which point EPA
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`may reach a very different conclusion about sulfoxaflor’s costs and benefits.
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`EPA’s near-Orwellian argument that sulfoxaflor is good for bees does not
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`withstand scrutiny. There is no evidentiary basis for EPA to assert vacatur may
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`cause growers to use alternative insecticides that are even more harmful. Instead,
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`the evidence confirms leaving sulfoxaflor’s registration in place during a
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`pollination crisis “risks more potential environmental harm than vacating it.”
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`Pollinator I, 806 F.3d at 532.
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`Arguments from EPA and Corteva (formerly, Dow) about the economic
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`consequences of vacatur are likewise unfounded. In fact, the States that produce
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`the lion’s share of the fruits, nuts, berries, and other bee-attractive crops EPA
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`3
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`improperly added to sulfoxaflor’s label have asked the Court to “vacate EPA’s
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`registration of sulfoxaflor.” States’ Amicus Br. (DktEntry 40) at 2.
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`In short, this case does not present the “rare circumstances” in which equity
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`demands remand without vacatur. Humane Soc. v. Locke, 626 F.3d 1040, 1053
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`(9th Cir. 2010). EPA’s decision must be “set aside” and remanded so EPA can
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`collect the data and conduct the public process FIFRA requires. 7 U.S.C. § 136n.
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`ARGUMENT
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`I.
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`The Court Should Address the Merits of Beekeepers’ FIFRA Claims
`Before Remanding EPA’s Registration Decision.
`A. EPA Does Not Intend to Reconsider Its Registration Decision.
`There is no reason for the Court to pass over the merits of Beekeepers’
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`FIFRA claims, because EPA does not intend to reconsider its FIFRA decision.
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`Instead, EPA seeks a remand so it can (1) comply with the ESA and (2) “provide
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`additional detail on why the FIFRA standard is satisfied on this record.” EPA Br.
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`2. From Beekeepers’ perspective, EPA “is essentially promoting a meaningless
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`remand” and inviting Beekeepers “to a party with no cake.” Skagit Cty. Pub.
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`Hosp. Dist. No. 2 v. Shalala, 80 F.3d 379, 384 (9th Cir. 1996). EPA’s proposed
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`remand will not address the violations of FIFRA described in Beekeepers’ opening
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`brief, redress Beekeepers’ injuries, or eliminate the need for judicial review of
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`Beekeepers’ claims.
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`4
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`

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`Voluntary remands are judicially efficient only when agencies intend “to
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`cure their own mistakes rather than wasting the courts’ and the parties’ resources
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`reviewing a record that both sides acknowledge to be incorrect or incomplete.”
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`Ethyl Corp. v. Browner, 989 F.2d 522, 524 (D.C. Cir. 1993). Following this logic,
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`“[t]he leading voluntary remand cases confirm that agency reconsideration of the
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`action under review is part and parcel of a voluntary remand.” Limnia v. Dep’t of
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`Energy, 857 F.3d 379, 386-87 (D.C. Cir. 2017) (emphasis added). Absent the
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`agency’s intent to reconsider the decision at issue, voluntary remands only frustrate
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`judicial review and function “as a dismissal of a party’s claims.” Id.
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`The voluntary remand EPA has proposed here is inefficient, because EPA
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`has not acknowledged any substantive or procedural defect in its FIFRA decision.
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`EPA insists the existing evidentiary record “supports the decision made,” and EPA
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`intends to “substantiate its FIFRA decision on remand” without additional data or
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`public process. EPA Br. 54.
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`To be clear, EPA’s “plan to provide additional record explanation on
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`FIFRA” will not address the violations of FIFRA Beekeepers have briefed. EPA
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`Br. 2. EPA’s registration decision is illegal not because it lacks explanation, but
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`rather because (1) the evidentiary record is insufficient for EPA to conclude
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`sulfoxaflor presents a reasonable risk to bees, and (2) EPA did not provide the
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`requisite public process. No amount of additional explanation on the existing
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`5
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`record can address these fundamental violations of FIFRA. EPA is therefore off
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`base in its assertion that Beekeepers’ claims “primarily concern the adequacy of
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`the Agency’s explanation.” Id. at 35.
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`EPA’s belated decision to comply with the ESA by assessing whether
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`sulfoxaflor “may affect” threatened and endangered species is no more likely to
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`address Beekeepers’ claims, because honey bees receive no protection under the
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`ESA. Beekeepers’ injuries are the result of EPA’s failure to comply with FIFRA,
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`not the ESA, which is why Beekeepers did not challenge EPA’s ESA compliance.
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`According to EPA, compliance with the ESA will not require the agency to
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`reconsider its FIFRA decision. See EPA’s Mot. for Voluntary Remand (DktEntry
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`51-1) at 19.
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`In short, EPA does not plan to reconsider its FIFRA decision, so there is no
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`reason to avoid the merits of Beekeepers’ FIFRA claims.
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`B. Remanding EPA’s Decision Without Reaching the Merits Would
`Unduly Prejudice Beekeepers.
`The Court must also consider whether remanding this case without reaching
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`the merits could “unduly prejudice” Beekeepers. Util. Solid Waste Activities Grp.
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`v. EPA, 901 F.3d 414, 436 (D.C. Cir. 2018). Beekeepers would be severely
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`prejudiced for two reasons.
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`First, remanding this case without reaching the merits would prejudice
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`Beekeepers’ ability to obtain appropriate relief, because whether the equities favor
`
`6
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`vacatur pending remand depends in part upon the merits of Beekeepers’ claims.
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`For example, EPA’s argument that it committed no “serious” legal errors presumes
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`Beekeepers’ FIFRA claims lack merit. EPA Br. 34. Similarly, EPA’s argument
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`that “vacatur could cause environmental harm” presumes “the FIFRA record
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`supports the conclusion that sulfoxaflor is less toxic than the most widely used
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`alternatives,” which Beekeepers’ dispute. Id. at 41. Whether the record contains
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`sufficient scientific data for EPA to assert that sulfoxaflor is “less risky” to bees
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`depends upon the merits of Beekeepers’ claims.
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`Second, EPA’s proposed remand could frustrate Beekeepers’ statutory right
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`to judicial review of EPA’s FIFRA decision, because it may never culminate in a
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`“final action” or “order” subject to review under Section 16 of FIFRA, 7 U.S.C.
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`136n. EPA has represented it could “begin” its assessment of sulfoxaflor’s effect
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`on threatened and endangered species “this summer,” and EPA “believes” it could
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`“complete an assessment by spring of next year if preparation of a biological
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`evaluation is not necessary.”1 EPA Br. 26.
`
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`1 EPA’s own analysis strongly suggests preparation of a biological evaluation will
`be necessary, because EPA found sulfoxaflor’s use on many crops will result in a
`“risk quotient” (RQ) that exceeds EPA’s “level of concern” (LOC) for many
`species that will be exposed. PSCER360-61. According to EPA, “[a]n initial ‘may
`affect’ finding is made for species that may be co-located with a potential use site
`AND either an acute or chronic RQ exceeds the appropriate LOC for the relevant
`taxonomic group.” EPA’s 2nd Decl., ¶15(g).
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`7
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`Notably, EPA commits to no deadline for completing its proposed remand.
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`Nor does EPA confirm its remand will culminate in another opportunity for
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`judicial review of Beekeepers’ FIFRA claims. EPA has certainly not made a
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`“commitment to taking new final action in the very near term.” Corteva Br. 42.
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`Given EPA’s track record of delay and obfuscation in pesticide cases, it could
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`require a writ of mandate for EPA to take any action on remand, let alone a final
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`action subject to review under FIFRA. See, e.g., In re Nat. Res. Def. Council v.
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`EPA, 956 F.3d 1134, 1139 (9th Cir. 2020); League of United Latin Am. Citizens v.
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`Regan, 996 F.3d 673, *3 (9th Cir. 2021). Meanwhile, the statute of limitations for
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`challenging the registration decision now at issue has already expired. See United
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`Farm Workers v. EPA, 592 F.3d 1080, 1083 (9th Cir. 2010).
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`For both these reasons, remanding EPA’s registration without reaching the
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`merits would unduly prejudice Beekeepers.
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`C. No Intervening Change in Law Warrants Remanding EPA’s
`Decision Without Reaching the Merits.
`Finally, there has been no intervening change in law to warrant remanding
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`
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`EPA’s registration decision without reaching the merits of Beekeepers’ claims.
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`EPA’s obligations under the ESA have not changed since Beekeepers petitioned
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`this Court to review the decision at issue. It has been over 15 years since EPA
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`“acknowledged its duty to make an effects determination and, if required, consult
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`under ESA section 7 prior to issuing a registration for a pesticide.” EPA Br. 9
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`8
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`(citing Washington Toxics Coal. v. EPA, 413 F.3d 1024 (9th Cir. 2005)). EPA
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`understood its obligations under the ESA when it registered sulfoxaflor’s new uses,
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`and EPA made a calculated decision to violate the ESA at that time. See
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`PSCER10. Under the circumstances, EPA’s decision to reverse course and comply
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`with the ESA appears motivated solely by the agency’s desire to extricate itself
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`from this litigation.
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`EPA’s obligations under FIFRA are also unchanged. EPA misconstrues the
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`Court’s opinion in Nat’l Family Farm Coal. v. EPA, 960 F.3d 1120 (9th Cir.
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`2020), as an intervening event that “elucidates the FIFRA standard.” EPA Br. 17.
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`In fact, Nat’l Family Farm merely confirms EPA’s longstanding duty under
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`FIFRA “to consider, as part of a cost-benefit analysis, ‘any unreasonable risk to
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`man or the environment, taking into account the economic, social, and
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`environmental costs and benefits of the use of any pesticide.’” 960 F.3d at 1142
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`(quoting 7 U.S.C. § 136(bb)). Nat’l Family Farm did not turn on some novel
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`interpretation of FIFRA, but rather on the facts. Cf. Nat’l Fuel Gas Supply Corp.
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`v. Fed. Energy Reg. Comm’n, 899 F.2d 1244, 1247-50 (remanding for the agency
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`to address a judicial opinion invaliding the administrative order that formed the
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`basis for the agency decision under review).
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`In short, there have been no intervening changes in law since Beekeepers
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`petitioned the Court to review EPA’s decision to register new uses for sulfoxaflor.
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`9
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`For all these reasons, the Court should rule on the merits of Beekeepers’ claims
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`before remanding to EPA.
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`II. This Is Not an Exceptional Case Warranting Remand Without Vacatur.
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`“[V]acatur of an unlawful agency action normally accompanies a remand.”
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`Alsea Valley All. v. Dep’t of Com., 358 F.3d 1181, 1185 (9th Cir. 2004); accord
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`Standing Rock Sioux Tribe v. Army Corps of Engineers, 985 F.3d 1032, 1050 (D.C.
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`Cir. 2021) (“The ordinary practice . . . is to vacate unlawful agency action.”).
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`Remand without vacatur is warranted “only in limited circumstances” and “only
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`when equity demands.” Pollinator I, 806 F.3d at 532.
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`
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`None of the exceptional circumstances warranting remand without vacatur
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`are present here. EPA committed multiple, serious violations of law when it
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`registered sulfoxaflor’s new uses, and addressing those violations will require
`
`additional data and public process. Leaving EPA’s illegal decision in place is not
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`necessary to prevent environmental harm, and vacating EPA’s decision will not
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`have significant disruptive consequences.
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`A. EPA Committed Many Serious Violations of Law.
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`1.
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`EPA Still Lacks Sufficient Data to Conduct the Required
`Assessment of Risk to Bees.
`EPA committed serious violations of law when it registered sulfoxaflor for
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`use on bee-attractive crops before and during bloom. Foremost among them, EPA
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`still lacks sufficient scientific data to assess sulfoxaflor’s risk to bees and therefore
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`10
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`

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`still has “no real idea whether sulfoxaflor will cause unreasonable adverse effects
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`on bees, as prohibited by FIFRA.” Pollinator I, 806 F.3d at 532. EPA’s failure to
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`assess sulfoxaflor’s toxicity to bees in accordance with its regulations and guidance
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`remains a serious legal violation requiring vacatur. Id.
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`The additional Tier 2 studies EPA received from Corteva in 2018 did not
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`resolve the data gaps identified by this Court in Pollinator I. As detailed on pages
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`23 to 33 of Beekeepers’ opening brief, EPA determined Corteva’s additional Tier 2
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`studies indicated “a potential for colony-level risk,” PSCER362-63, because they
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`show colonies will be exposed to levels of sulfoxaflor that exceed EPA’s “lowest
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`observed adverse effect concentration” (LOAEC) and/or “no observed adverse
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`effects concentration” (NOAEC). PSCER441-87. EPA therefore concluded
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`Corteva’s Tier 2 studies triggered the legal requirement for Tier 3 field studies.
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`See 40 C.F.R. § 158.630(d) and (e) n.25 (requiring Tier 3 studies when data
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`“indicate potential adverse effects on colonies”); PSCER346 (EPA concluding
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`“field testing for sulfoxaflor would be required under 40 CFR Part 158.630.”).
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`EPA’s decision to register sulfoxaflor in the absence of Tier 3 studies is
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`unsupported by substantial evidence. EPA claims “Tier 2 studies provide a more
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`conservative estimate of the impacts of exposure to sulfoxaflor than Tier 3
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`studies.” EPA Br. 50-51. But here, Corteva’s Tier 2 studies indicated colonies’
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`exposure to sulfoxaflor often exceed EPA’s own thresholds of concern for colony-
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`level risk—i.e., the LOAEC and NOAEC.2 This Court has made clear it “cannot
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`allow the EPA to avoid its own regulations when actual measurements trigger risk
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`concerns.” Pollinator I, 806 F.3d at 531. “EPA chose to set its level of concern at
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`a measurement it now feels is overly conservative, but a court cannot alter the
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`agency’s own rule.” Id.; see also Natural Res. Def. Council v. EPA, 735 F.3d 873,
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`884 (9th Cir. 2013) (“Nor can we revise EPA’s assumptions, alter its rule of
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`decision, or perform our own risk assessment.”).
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`EPA’s argument that Corteva’s Tier 2 studies were “adequate” is further
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`belied by the agency’s record-based finding that the Tier 2 studies were lacking in
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`two key respects. First, EPA concluded Corteva’s Tier 2 studies were unable to
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`assess sulfoxaflor’s effect on colonies’ overwintering success at higher application
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`rates. PSCER436-37. EPA explained only two of Corteva’s Tier 2 tunnel studies
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`(the “North Carolina” and “Kansas” studies) evaluated sulfoxaflor’s overwinter
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`effect on colonies at application rates above 0.04 pounds of active ingredient per
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`acre (lb a.i./A), which is less than half the maximum application rate. PSCER426-
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`31. In both studies, most hives exposed to higher application rates failed to survive
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`2 For example, EPA concluded “the colony level NOAEC . . . is exceeded for at least
`15 days by a maximum of 6X” when sulfoxaflor is applied to citrus. PSCER448.
`EPA found substantial exceedances of the NOAEC and LOAEC for many other crops.
`See PSCER442 (cucurbits), 445 (stone fruits), 460 (small fruits and berries), 469 (non-
`grass animal feeds), 477 (other orchard crops). EPA explained exceedances of the
`NOAEC and LOAEC trigger “a colony level ‘risk’ conclusion.” PSCER441.
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`through winter. PSCER249 (“[C]olonies in control, 0.023, 0.071, and 0.090
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`lb a.i./A treatments had overwintering survival rates of 50, 83, 17 and 17%
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`respectively.”); PSCER430 (“Colonies in control, 0.023, 0.070 and 0.090 lb a.i./A
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`treatments had overwintering survival rates of 37, 33, 17, and 50% respectively.).
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`EPA nevertheless deemed these results “inconclusive,” due to the number of
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`control colonies that also failed to overwinter.3 PSCER431.
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`In short, Corteva’s additional Tier 2 studies were unable to gauge whether
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`sulfoxaflor’s registered uses will cause colonies to collapse overwinter. EPA’s
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`failure to assess sulfoxaflor’s overwinter effects is significant, because according
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`to EPA “[t]he number of hives that do not survive over the winter months” is “the
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`overall indicator for bee health.” See EPA, Pollinator Protection (Apr. 26, 2018),
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`https://www.epa.gov/pollinator-protection/colony-collapse-disorder.
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`Second, Corteva’s additional Tier 2 studies were unable to assess the effect
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`of exposing colonies to sulfoxaflor for more than 10 days. PSCER497-98. In
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`general, Tier 2 tunnel studies “can only accommodate relatively short exposure
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`periods in the tunnel (e.g., up to 10 days or so) due to confinement-related stress on
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`3 Corteva’s two Tier 2 colony feedings studies were equally alarming, but ultimately
`unable to assess sulfoxaflor’s overwinter effects. EPA explained only 60% of hives
`fed higher doses of sulfoxaflor survived through winter in Corteva’s “Germany”
`colony feeding study, “compared to 100% in controls and lower treatments.”
`PSCER435. Overwinter survival rates ranged from 25-75% in Corteva’s “U.S.”
`colony feeding study, but EPA concluded the failure rate among controls “invalidated
`the overwintering portion of this study.” PSCER434, 436.
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`the bees.” PSCER1278. Here, Corteva’s Tier 2 tunnel studies evaluated the effect
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`of exposing colonies to sulfoxaflor “for 7-10 days.” PSCER424. According to
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`EPA’s pollinator risk assessment White Paper, “this relatively short exposure
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`period introduces uncertainty when attempting to relate results to longer-term
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`exposures that bees may experience in the field (e.g., commercial hives being
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`moved to multiple crops in a growing season).” PSCER1107-08.
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`In theory, Tier 2 colony feeding studies “can provide information on the
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`effects to honey bees over longer durations of exposure compared to tunnel
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`studies.” PSCER1278. Here, however, one of Corteva’s two colony feeding
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`studies (the Germany study) exposed colonies to sulfoxaflor for only10 days.
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`PSCER434. And while the other colony feeding study (the U.S. study) exposed
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`hives to sulfoxaflor for 42 days, EPA found “several major uncertainties associated
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`with the US colony feeding study render it unsuitable for quantitative use in risk
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`assessment.” PSCER438. EPA determined the U.S. study was “unable to provide
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`conclusive data regarding the effects of 42-d[ay] oral exposures.” PSCER438.
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`Because Corteva’s Tier 2 studies could not assess the effect of exposing
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`colonies to sulfoxaflor for more than 10 days, EPA concluded “there is a potential
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`for the oral Tier II risk assessments results to underestimate colony-level risk to
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`honey bees.” PSCER498. EPA explained, “there is a potential for repeated
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`applications of sulfoxaflor to honey-bee attractive crops during or near bloom to
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`result in combined oral exposures that exceed the 10-d[ay] exposure duration of
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`the colony feeding study upon which the Tier II oral risk assessment is based.”
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`PSCER497. In addition, “colonies used to pollinate multiple crops in succession
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`could potentially become exposed to sulfoxaflor for combined time periods lasting
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`longer than 10 days.” Id. EPA does not know what effect these longer-term
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`exposures to sulfoxaflor will have on colonies.4
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`Given EPA’s assessment of Corteva’s Tier 2 studies, there is no basis for
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`EPA’s speculation that “Tier 3 studies would not add significant value and clarity
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`to the risk management decision.” EPA Br. 52. EPA’s 2016 guidance for
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`assessing a pesticide’s risk to bees specifically recommends Tier 3 studies where,
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`as in the case of sulfoxaflor, “Tier 2 studies either under semi-field tunnel
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`conditions and/or feeding studies have indicated potential adverse effects at the
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`colony level.” PSCER1279. EPA’s 2016 guidance also confirms Tier 3 studies
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`can help “to address specific uncertainties that are identified in the lower-tier
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`studies.” Id. Specifically, Tier 3 studies can assess “effects on the ability of
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`4 Corteva is mistaken in asserting colon