case nos. 17-70810, 17-70817 united states court of ... · 4/11/2018 · case nos. 17-70810,...

Case Nos. 17-70810, 17-70817

UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT

______________________________________________________________________________

NATIONAL FAMILY FARM COALITION, ET AL., Petitioners,

v. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, et al.,

Respondents, DOW AGROSCIENCES LLC,

Respondent-Intervenor. ______________________________________________________________________________

NATURAL RESOURCES DEFENSE COUNCIL, Petitioner,

v. SCOTT PRUITT, ET AL.,


Respondent-Intervenor. ______________________________________________________________________________

On Petition for Review of an Order of the United States Environmental Protection Agency

______________________________________________________________________________

BRIEF OF PETITIONER NATURAL RESOURCES DEFENSE COUNCIL Margaret T. Hsieh Mitchell S. Bernard Kaitlin Morrison Natural Resources Defense Council 40 West 20th Street New York, NY 10011 Telephone: (212) 727-2700

Peter J. DeMarco Natural Resources Defense Council 1152 15th Street NW Suite 300 Washington, DC 20005 Telephone: (202) 289-6868

Counsel for Petitioner Natural Resources Defense Council Dated: April 11, 2018

Case: 17-70810, 04/11/2018, ID: 10832785, DktEntry: 63, of 139

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CORPORATE DISCLOSURE STATEMENT REQUIRED BY FED. R. APP. P. 26.1

Petitioner Natural Resources Defense Council, Inc. (NRDC) is a non-profit

corporation with no parent corporation and no outstanding stock shares or other

securities in the hands of the public. NRDC does not have any parent, subsidiary,

or affiliate that has issued stock shares or other securities to the public. No publicly

held corporation owns any stock in NRDC.


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TABLE OF CONTENTS

CORPORATE DISCLOSURE STATEMENT .......................................................... i TABLE OF AUTHORITIES .................................................................................... iv INTRODUCTION ..................................................................................................... 1 STATEMENT OF JURISDICTION.......................................................................... 4 ISSUES PRESENTED ............................................................................................... 6 STATUTORY AND REGULATORY FRAMEWORK ........................................... 6 I. Unconditional pesticide registration ................................................................ 7 II. Conditional pesticide registration .................................................................... 8 STATEMENT OF THE CASE ................................................................................ 10 I. Enlist Duo is a new pesticide combining 2,4-D and glyphosate that will increase 2,4-D use and bolster glyphosate use ....................................... 10 II. Enlist Duo poses a significant risk to monarch butterflies ............................ 14 III. Enlist Duo may pose serious risks to human health ...................................... 22 IV. Procedural history .......................................................................................... 23 A. EPA’s previous registration orders (2014 and 2015) .......................... 23 B. EPA’s current registration order (2017) .............................................. 25 SUMMARY OF ARGUMENT ............................................................................... 30 STANDARD OF REVIEW ..................................................................................... 33


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ARGUMENT ........................................................................................................... 35 I. EPA’s registration of Enlist Duo is unlawful because FIFRA does not

authorize EPA to register a new pesticide under § 136a(c)(7)(B) ................ 35 A. EPA’s registration of Enlist Duo contravenes the plain text of § 136a(c)(7)(B) ........................................................................ 35 B. EPA fails to provide a reasonable explanation that reconciles its registration of Enlist Duo with the plain text of § 136a(c)(7)(B) ........................................................................ 38 C. EPA’s misguided approach to § 136a(c)(7)(B) undermines

FIFRA’s core purpose because it allows new pesticides on the market without adequate assessment of their risks .................. 40

II. EPA’s registration of Enlist Duo under § 136a(c)(7)(B) is not supported by substantial evidence because EPA failed adequately to consider increased risk of harm to monarch butterflies and human health ................. 43 A. EPA declined to assess harm to milkweed and monarchs from Enlist Duo’s expansion of 2,4-D use .......................................... 44 B. EPA ignored evidence that registering Enlist Duo would result in increased glyphosate use over time and thereby amplify risks that glyphosate poses to both monarchs and humans ................. 47 III. NRDC has standing to challenge EPA’s registration of Enlist Duo ............. 49 CONCLUSION ........................................................................................................ 52 STATEMENT OF RELATED CASES ................................................................... 54 CERTIFICATE OF COMPLIANCE ....................................................................... 55 CERTIFICATE OF SERVICE ................................................................................ 56 ADDENDUM OF STATUTES AND REGULATIONS ............................ ADD 001 ADDENDUM OF DECLARATIONS IN SUPPORT OF STANDING ..... ADD 049


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TABLE OF AUTHORITIES

CASES Benitez v. Califano, 573 F.2d 653 (9th Cir. 1978) ......................................................................... 38 Burlington Truck Lines v. United States, 371 U.S. 156 (1962)....................................................................................... 34 Cent. Delta Water Agency v. United States, 306 F.3d 938 (9th Cir. 2002) ......................................................................... 51 Containerfreight Corp. v. United States, 752 F.2d 419 (9th Cir. 1985) ......................................................................... 33 Cty. of Amador v. U.S. Dep’t of Interior, 872 F.3d 1012 (9th Cir. 2017) ...................................................................... 42 Dilley v. Gunn, 64 F.3d 1365 (9th Cir. 1995) ......................................................................... 49 Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S. 167 (2000)....................................................................................... 50 Hunt v. Wash. State Apple Advert. Comm’n, 432 U.S. 333 (1977)................................................................................. 49, 50 L.A. Lakers, Inc. v. Fed. Ins. Co., 869 F.3d 795 (9th Cir. 2017) ......................................................................... 35 Lujan v. Defs. of Wildlife, 504 U.S. 555 (1992)................................................................................. 50, 51 Ma v. Ashcroft, 361 F.3d 553 (9th Cir. 2004) ......................................................................... 43 Mont. Wilderness Ass’n v. McAllister, 666 F.3d 549 (9th Cir. 2011) ....................................................... 34, 46, 47, 49


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Motor Vehicle Mfrs. Ass’n of U.S. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983) ....................................................................... 34, 46, 47, 49 Nat’l Ass’n of Mfrs. v. Dep’t of Def., 138 S. Ct. 617 (2018) ..................................................................................... 37 NRDC v. EPA (Nanosilver I), 735 F.3d 873 (9th Cir. 2013) ....................................................... 33, 34, 39, 51 NRDC v. EPA (Nanosilver II), 857 F.3d 1030 (9th Cir. 2017) ..................................................... 33, 34, 39, 48 Nw. Coal. for Alternatives to Pesticides v. EPA, 544 F.3d 1043 (9th Cir. 2008) ......................................................................... 7 N.Y. State Pesticide Coal., Inc. v. Jorling, 874 F.2d 115 (2d Cir. 1989) .......................................................................... 42 Pollinator Stewardship Council v. EPA,

806 F.3d 520 (9th Cir. 2015) ......................................... 1, 7, 33-34, 34, 41, 46 Sultan Chemists, Inc. v. EPA, 281 F.3d 73 (3d Cir. 2002) ...................................................................... 40, 42 Union Oil Co. of Cal. v. Fed. Power Comm’n, 542 F.2d 1036 (9th Cir. 1976) ................................................................. 33, 46 Util. Air Regulatory Grp. v. EPA, 134 S. Ct. 2427 (2014) ................................................................................... 37 United Farm Workers of Am., AFL-CIO v. Adm’r, EPA, 592 F.3d 1080 (9th Cir. 2010) ......................................................................... 4 Yith v. Nielsen, 881 F.3d 1155 (9th Cir. 2018) ....................................................................... 35


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STATUTES AND REGULATIONS 7 U.S.C. § 136 .......................................................................................................... 36 7 U.S.C. § 136(a) ....................................................................................................... 7 7 U.S.C. § 136(bb) ........................................................................................... 1, 7, 40 7 U.S.C. § 136(t) ........................................................................................................ 6 7 U.S.C. § 136(u) ....................................................................................... 6, 7, 36, 38 7 U.S.C. § 136a(a) ................................................................................................ 6, 43 7 U.S.C. § 136a(c)(1)(F) .......................................................................................... 42 7 U.S.C. § 136a(c)(5) ............................................................................... 7, 26, 31, 41 7 U.S.C. § 136a(c)(5)(C) ............................................................................ 7, 8, 28, 31 7 U.S.C. §136a(c)(5)(D) .................................................................................. 7, 8, 31 7 U.S.C. § 136a(c)(7) ............................................................................................. 7, 8 7 U.S.C. § 136a(c)(7)(A) ................................................................................... 26, 29 7 U.S.C. § 136a(c)(7)(B) ...................................................................................passim 7 U.S.C. § 136a(g) ..................................................................................................... 9 7 U.S.C. § 136n(b) ........................................................................................... 4, 5, 33 40 C.F.R. § 23.6 ......................................................................................................... 5 40 C.F.R. § 152.44 ..................................................................................................... 7 40 C.F.R. § 152.112(b) ........................................................................ 7-8, 31, 41, 42 40 C.F.R. § 152.112(c) ......................................................................................... 8, 31


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40 C.F.R. § 152.112(e) ......................................................................................... 7, 31 40 C.F.R. § 155.40 ..................................................................................................... 9 40 C.F.R. § 155.42 ..................................................................................................... 9 40 C.F.R. § 155.53(a) ................................................................................................. 9 40 C.F.R. § 158.75 ............................................................................................... 7, 31


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INTRODUCTION

Petitioner Natural Resources Defense Council (NRDC) challenges the

unlawful order of Respondents Scott Pruitt and U.S. Environmental Protection

Agency (together, EPA) registering Enlist Duo herbicide under the Federal

Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA’s order violates FIFRA

because the agency applied the wrong legal standard in registering Enlist Duo. In

the alternative, the order contravenes that standard because EPA had “no real

idea,” Pollinator Stewardship Council v. EPA, 806 F.3d 520, 532 (9th Cir. 2015),

of whether Enlist Duo will “significantly increase the risk of any unreasonable

adverse effect” on human health or the environment, 7 U.S.C. § 136a(c)(7)(B); see

id. § 136(bb). Of particular concern, EPA failed to consider Enlist Duo’s potential

to destroy crucial monarch butterfly habitat, and ignored recent science on the

herbicide’s human health risks.

Enlist Duo threatens the vulnerable remnant of North American monarch

butterflies. The monarch butterfly, Danaus plexippus, is an iconic species famed

for its annual migration across the continent. But the migrating population of

butterflies has declined precipitously in recent years. This decline has been driven

in large part by the sharply increasing use of herbicides enabled by herbicide-

resistant crops, which has decimated milkweed, the sole food source for monarch

caterpillars. In 1997, nearly 700 million monarchs journeyed from summer habitat


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in the United States and Canada to wintering grounds in Mexico. That number has

fallen by over 80 percent. A 2014 survey found only about 25 million butterflies—

a record low—in their winter refuge. Scientists warn that the monarch population

faces a significant risk of collapse within the next twenty years.

Enlist Duo is a new herbicide that combines the active ingredients 2,4-

dichlorophenoxyacetic acid (2,4-D) and glyphosate. Both 2,4-D and glyphosate kill

the milkweed that sustains the monarch migration. Enlist Duo is designed for use

on corn, soybeans, and cotton that have been engineered to resist 2,4-D and

glyphosate. This allows more Enlist Duo to be sprayed on the crops to kill weeds,

without damaging the crops themselves. Registration of the herbicide will

significantly increase overall 2,4-D use and bolster glyphosate use. Although

NRDC requested that EPA evaluate Enlist Duo’s potential to harm monarchs by

destroying milkweed, EPA evaded the issue and registered the herbicide for use in

thirty-four states squarely within the butterflies’ migration path.

The agency also ignored NRDC’s request to fully evaluate the effects of

glyphosate on human health. Over the past decade, scientists have published a

significant number of peer-reviewed studies on glyphosate’s health risks, including

research suggesting that glyphosate may cause serious harms such as kidney

toxicity and birth defects. Despite troubling questions that the recent studies raise


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about glyphosate’s safety to humans, EPA declined to review much of this new

science prior to registering Enlist Duo.

EPA may not rely on 7 U.S.C. § 136a(c)(7)(B), the FIFRA standard under

which the agency unlawfully chose to register Enlist Duo, to justify its failure to

evaluate critical evidence of the herbicide’s risks. Section 136a(c)(7)(B) narrowly

authorizes EPA to “amend” previously approved registrations. But Enlist Duo is a

new herbicide without any preexisting registration to amend; consequently, EPA

may not register Enlist Duo under that provision. To circumvent this limitation,

EPA treated the application to register Enlist Duo as if it were simply an

application to amend a prior registration of 2,4-D. But § 136a(c)(7)(B) provides no

basis for transmuting an amended registration for 2,4-D into a brand-new

registration for Enlist Duo. This approach violates the plain statutory text.

In the alternative, even if EPA may register the new uses of Enlist Duo

under § 136a(c)(7)(B) in defiance of the unambiguous statutory language, the

registration is not supported by substantial evidence. The agency failed to make the

mandatory showing that Enlist Duo would not “significantly increase the risk of

any unreasonable adverse effect on the environment,” because it ignored evidence

of amplified risks to monarchs from milkweed destruction, and of extended risks to

human health. 7 U.S.C. § 136a(c)(7)(B). EPA’s registration of Enlist Duo therefore

violates FIFRA and should be vacated.


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STATEMENT OF JURISDICTION

This Court has jurisdiction under FIFRA, which provides for review in the

courts of appeals of “any order issued by the Administrator following a public

hearing.” 7 U.S.C. § 136n(b). NRDC is challenging EPA’s final order registering

Enlist Duo for use in thirty-four states. ER 1-36. The order followed a public

hearing because EPA solicited and reviewed public comments before issuing the

order. See United Farm Workers of Am., AFL-CIO v. Adm’r, EPA, 592 F.3d 1080,

1082-84 (9th Cir. 2010).

NRDC may bring this action because it was “a party to the proceedings”

before EPA and is “adversely affected” by EPA’s order registering Enlist Duo.

7 U.S.C. § 136n(b). NRDC participated in the agency proceedings by timely

submitting comments opposing the proposed registration. ER 144-211. In its

comments, NRDC asserted that EPA cannot lawfully register Enlist Duo without

adequately assessing potential adverse effects on monarch butterflies and human

health. ER 146-51, 158-78.

NRDC and its members are adversely affected by EPA’s registration of

Enlist Duo.1 NRDC has members who live in agricultural regions in states where

EPA approved the use of Enlist Duo, and EPA’s action increases the risk that these

1 As discussed further below, these adverse effects give NRDC standing to challenge the registration order. See infra Argument III.


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members will suffer health harms from exposure to the herbicide. See Bristol Decl.

¶¶ 2-8 (ADD 051-53); Gruber Decl. ¶¶ 3-9 (ADD 058-61); Wetzel Decl. ¶¶ 3-9, 15

(ADD 069-72, 074).2 Registration of Enlist Duo also injures NRDC’s members

who derive aesthetic and recreational enjoyment from watching and interacting

with monarchs, because Enlist Duo kills milkweed and hence exacerbates monarch

decline. See Bristol Decl. ¶¶ 10-14 (ADD 053-54); Gruber Decl. ¶¶ 10-12 (ADD

061); Wetzel Decl. ¶¶ 10-15 (ADD 072-74).

Finally, NRDC’s petition is timely and venue is proper in this Court because

NRDC filed the petition “in the United States court of appeals for the circuit

wherein [NRDC] resides or has a place of business, within 60 days after the entry

of [the challenged] order.” 7 U.S.C. § 136n(b). EPA’s final order registering Enlist

Duo for use in thirty-four states was signed on January 12, 2017, and entered

fourteen days later, on January 26, 2017. See 40 C.F.R. § 23.6; Case No. 17-70817,

ECF No. 22-1, at 1-2. NRDC filed a petition for review challenging that order on

March 21, 2017. See ER 1; Case No. 17-70817, ECF No. 1-5. Venue is proper

because NRDC has offices within the Ninth Circuit, in San Francisco and Santa

Monica, California, and in Bozeman, Montana. Trujillo Decl. ¶ 4 (ADD 065).

2 “ADD” indicates the page number in the addendum of standing

declarations bound with this brief.


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ISSUES PRESENTED

I. Did EPA violate FIFRA by registering Enlist Duo—a new pesticide—under

§ 136a(c)(7)(B), which authorizes the agency only to “amend the registration of a

pesticide to permit additional uses of such pesticide”? 7 U.S.C. § 136a(c)(7)(B).

II. In the alternative, even if EPA may register the inaugural uses of Enlist Duo

under § 136a(c)(7)(B), did the agency lack substantial evidence to conclude that

the herbicide would not “significantly increase the risk of any unreasonable

adverse effect on the environment,” id., because it failed to consider the

registration’s potential to destroy additional monarch butterfly habitat and to

extend risk to human health?

STATUTORY AND REGULATORY FRAMEWORK

Under FIFRA, any pesticide must be “registered” by EPA before it can be

sold or distributed in the United States. 7 U.S.C. § 136a(a). A “pesticide” includes

“any substance or mixture of substances intended for preventing, destroying,

repelling, or mitigating any pest,” id. § 136(u), including any “weed,” id. § 136(t),

and thus includes chemicals commonly known as herbicides (or weed killers).

Enlist Duo herbicide is a “pesticide,” because it is a mixture of active and inert

ingredients that is intended to kill weeds.3 Although glyphosate and 2,4-D are

3 EPA’s registration documents and this brief refer to Enlist Duo alternately

as an “herbicide” and a “pesticide.”


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“pesticides” as well, they are also “active ingredients” when used in the “pesticide”

Enlist Duo. See id. § 136(a), (u) (defining “active ingredient” and “pesticide”).

EPA may issue either an “unconditional” or “conditional” registration for a

pesticide. See id. § 136a(c)(5), (7).

I. Unconditional pesticide registration

FIFRA authorizes EPA to unconditionally register a new pesticide, or

unconditionally amend an existing pesticide registration, only upon determining

that the pesticide “will perform its intended function without unreasonable adverse

effects on the environment,” and that “when used in accordance with widespread

and commonly recognized practice it will not generally cause unreasonable

adverse effects on the environment.” Id. § 136a(c)(5)(C), (D); see 40 C.F.R.

§§ 152.112(e), 152.44; Nw. Coal. for Alternatives to Pesticides v. EPA, 544 F.3d

1043, 1045 (9th Cir. 2008). The statute defines “unreasonable adverse effects on

the environment” to 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.” 7 U.S.C. § 136(bb).

“Unconditional registration necessarily requires sufficient data to evaluate

the environmental risks.” Pollinator Stewardship Council, 806 F.3d at 523; see 40

C.F.R. § 158.75. Before unconditionally registering a pesticide under § 136a(c)(5),

EPA must review “all relevant data in the possession of the Agency,” 40 C.F.R.


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§ 152.112(b), and conclude “that no additional data are necessary to make the

determinations required by [that standard],” id. § 152.112(c)—including the

determinations that use of the pesticide will not cause unreasonable adverse

effects, see 7 U.S.C. § 136a(c)(5)(C), (D); Pollinator Stewardship Council, 806

F.3d at 528.

II. Conditional pesticide registration

If EPA lacks sufficient data to determine whether an application for a new or

amended pesticide registration warrants unconditional approval, the agency may

conditionally grant a new or amended registration for that pesticide—but only if

certain criteria are met. 7 U.S.C. § 136a(c)(7). Conditional registration allows a

pesticide to be marketed temporarily for specific uses on the condition that the

registrant submit, within a limited time, all remaining data necessary for EPA to

determine whether unconditional registration of those uses are justified. See id.

Although EPA may grant a conditional registration under three “special

circumstances,” id., only one is relevant here because it is the only one on which

the agency relied to register Enlist Duo, see ER 4, 30. Under § 136a(c)(7)(B):

The [EPA] Administrator may conditionally amend the registration of a pesticide to permit additional uses of such pesticide notwithstanding that data concerning the pesticide may be insufficient to support an unconditional amendment, if the Administrator determines that (i) the applicant has submitted satisfactory data pertaining to the proposed additional use, and (ii) amending the registration in the manner proposed by the applicant would not significantly increase the risk of any unreasonable adverse effect on the environment.


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Id. § 136a(c)(7)(B).

An applicant seeking amended registration under this provision “shall

submit such data as would be required to obtain registration of a similar pesticide

under [the unconditional registration standard].” Id. However, “[i]f the applicant is

unable to submit an item of data (other than data pertaining to the proposed

additional use) because it has not yet been generated,” the EPA Administrator may

amend the registration on the condition that the applicant submit the outstanding

data “not later than the time such data are required to be submitted with respect to

similar pesticides already registered.” Id. That time is usually during the periodic

“registration review” process, pursuant to which EPA must review every pesticide

registration to make sure it “still satisfies the FIFRA standard for registration” in

light of “new data or information.” 40 C.F.R. § 155.53(a); see 7 U.S.C. § 136a(g).

Registration review must be completed for each registered pesticide every fifteen

years, and the agency assesses all pesticide products containing the same active

ingredient as part of a single registration review case. See 40 C.F.R. §§ 155.40,

155.42.


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STATEMENT OF THE CASE

I. Enlist Duo is a new pesticide combining 2,4-D and glyphosate that will increase 2,4-D use and bolster glyphosate use

Enlist Duo is a pesticide manufactured by Dow AgroSciences, LLC (Dow)

that contains the active ingredients 2,4-D and glyphosate. ER 2. Although there are

various forms of 2,4-D and glyphosate, the specific forms found in Enlist Duo are

2,4-dichlorophenoxyacetic acid choline salt (2,4-D choline salt) and glyphosate

dimethylammonium salt. See id.

Enlist Duo is designed and registered for use on Enlist Duo-resistant corn,

soybean, and cotton crops—that is, crops that have been genetically engineered

(GE) to resist both 2,4-D and glyphosate, allowing Enlist Duo to be sprayed later

in the growing season and in greater amounts, to kill weeds without killing treated

crops. ER 321, 558, 1763-64. Although EPA had previously registered other

pesticides containing 2,4-D for limited uses on 2,4-D-resistant corn, soybeans, and

cotton, Enlist Duo is the first pesticide that EPA registered for additional,

expanded uses on those crops. See ER 28. In contrast, all of Enlist Duo’s uses of

glyphosate on glyphosate-resistant corn, soybeans, and cotton are shared by

previously registered pesticides containing glyphosate (many developed by

Monsanto Co. and marketed under the trade name Roundup). See ER 1-3, 387.

EPA acknowledged that registration of Enlist Duo “will result in an

increased usage of 2,4-D.” ER 83, 158. This is primarily because of the new and


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expanded ways in which the registration allows 2,4-D to be used. See ER 28, 158.

Compared to other pesticides containing 2,4-D, Enlist Duo contemplates use of

2,4-D on 2,4-D-resistant corn for a significantly longer part of the growing season;

on 2,4-D resistant soybean plants after they have emerged from the ground; and on

2,4-D-resistant cotton plants after they have emerged from the ground but before

they are harvested.4 See ER 28 (explaining in further detail why registration of

Enlist Duo would expand 2,4-D use), 547, 558, 1763-64. The U.S. Department of

Agriculture made similar findings and predicted that approval of Enlist Duo will

cause a 200 to 600 percent increase in the overall use of 2,4-D. See ER 353.

While recognizing that registration of Enlist Duo would augment overall

2,4-D use, EPA failed to consider evidence that the registration would bolster total

glyphosate use. The agency assumed (without citing any evidence) that Enlist Duo

will not “significantly change the locations, methods, or volume of glyphosate used

on corn, soybeans, or cotton” and that “any decision on the Enlist DuoTM

registration . . . would only impact which glyphosate product would be used.” ER

4; accord ER 84. But the agency did not actually assess how registration of Enlist

4 Enlist Duo entails the very first uses of 2,4-D choline salt on 2,4-D-

resistant corn, soybeans, and cotton. See ER 3. However, non-choline-salt forms of 2,4-D have previously been registered for more limited uses on these crops, including use on 2,4-D-resistant corn during an early phase of the growing season; use on 2,4-D-resistant soybeans before planting; and use on 2,4-D-resistant cotton before planting, for spot treatment, and after harvest. See ER 28.


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Duo would affect total herbicide loading in the environment. See ER 1769. Rather,

EPA noted that the analysis was “difficult” and the agency could reach no

conclusions. Id.

Contrary to EPA’s unsubstantiated assumption that registration of Enlist

Duo would have no material effect on overall glyphosate use, evidence in the

record indicates that the registration would abate or even reverse likely declines in

glyphosate use. The evidence indicates that widespread use of glyphosate is

causing weeds to develop resistance to the chemical, and that Enlist Duo provides

growers with a unique means of addressing that problem. See ER 155-57, 1763,

1769.

In 2014, the U.S. Department of Agriculture recognized that the “nearly

exclusive use of glyphosate over the past fifteen years led to the selection of

glyphosate-resistant . . . weeds, weeds that could survive an application of the

herbicide.” ER 346. A 2012 survey of farmers in thirty-one states found that 49

percent reported having glyphosate-resistant weeds in their fields. ER 2005.

During the Enlist Duo registration process, Dow represented that “increasing

prevalence of glyphosate-resistant” weeds is “rapidly getting worse.” ER 2133,

2136. EPA concurred, acknowledging that “resistance to glyphosate . . . has

become a significant economic and pest management issue to growers.” ER 28; see

ER 559.


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Glyphosate is rapidly losing efficacy, falling victim to its own popularity.

ER 156-57. In comments to EPA, members of the agricultural industry reported

that many growers are resorting to non-glyphosate-based pesticides. See, e.g., ER

459 (“[O]nce glyphosate resistant weeds started to show up nearly everyone would

use 2,4-D or some dicamba product to control weeds.”). Agricultural scientists

echoed this observation. See, e.g., ER 508. Likewise, in case studies that Dow

submitted to EPA, growers in areas infested with glyphosate-resistant weeds used a

“variety of alternatives” to glyphosate, including not only other pesticides, but also

increased tillage. ER 1766; see also ER 2136 (asserting that without new pesticides

like Enlist Duo “to address problems with glyphosate-resistant weeds, U.S.

growers will be forced to revert to earlier cultural practices”). Recognizing the

severity of the problem, EPA concluded that “[t]he continued viability of the

glyphosate . . . technology is widely predicated on the containment of currently

resistant weed biotype populations and the delay of any future resistant weed

biotype population development.” ER 1768.

Enlist Duo is a “tool that could prolong the viability of the glyphosate

herbicide technology.” ER 1769; accord ER 28, 156, 558, 1763. Its two active

ingredients have different mechanisms of action, which means that the 2,4-D in

Enlist Duo can kill glyphosate-resistant weeds and stave off further weed

resistance to glyphosate. ER 28, 156-57, 1762-64, 1768-69. This would allow more


14

glyphosate to remain on the market, for a longer time. Therefore, at a minimum,

Enlist Duo is likely to perpetuate glyphosate use at levels well above what would

otherwise be expected. See ER 1763, 1769. Enlist Duo may even cause glyphosate

use to increase beyond current levels by, for example, allowing growers to expand

crop acreage. See, e.g., ER 458, 503; see also ER 560 (noting that “use of Enlist

Duo on GE cotton is not expected to eliminate the use of any other herbicide”). But

for Enlist Duo, there would be less use of both 2,4-D and glyphosate.

II. Enlist Duo poses a significant risk to monarch butterflies

The use of herbicides on herbicide-resistant crops is a leading cause in the

sharp decline of the eastern population of North American monarch butterflies.5

ER 159-73. Each spring, the monarch population embarks on a multi-generational

migration that begins in the forests of central Mexico. ER 266. The butterflies fly

north across the United States, reproducing along the way. Id. By mid-to-late

summer, over the span of four to five generations, the population reaches southern

Canada. See id. In the fall, the last generation of monarchs flies back to the same

forests in Mexico where the population’s journey began. See id. The butterflies

5 Monarch butterflies are found both east and west of the Rocky Mountains, although the western population is much smaller. ER 148 n.10. This brief focuses on the eastern population of North American monarchs because that population migrates across the thirty-four states where EPA has approved the use of Enlist Duo. See id.


15

overwinter in Mexico until spring, when the migration cycle begins again. See id.;

infra Figure 1. The entire migration spans over 2,500 miles. ER 170.

Fig. 1. Aerial photo showing trees tinged orange by an overwintering monarch butterfly colony at El Rosario Monarch Reserve, Michoacán, Mexico. (C) Lincoln Brower 1999.

Monarchs cannot complete this extraordinary migration without milkweed.

See ER 166-68, 212, 221-24, 266. Because monarch caterpillars eat only

milkweed, migrating female monarchs lay their eggs only on milkweed. ER 167,

231, 403. When milkweed is scarce, females deplete large amounts of body fat in

search of the plant, which can cause them to lay fewer eggs or even die before

laying any eggs. ER 167-68, 303-04. Fewer eggs means fewer monarchs. ER 270.

Reduction of milkweed also decreases the number of caterpillars that survive to


16

adulthood, by intensifying competition over a limited food supply. ER 298, 303-

04.

EPA registered the first pesticide containing glyphosate in 1974. ER 160. As

a non-selective herbicidal active ingredient, glyphosate does not discriminate

between target and non-target plant species: it can damage and kill both crops and

weeds. ER 2, 160, 267. For this reason, growers previously limited their use of

herbicides containing glyphosate. ER 267.

In the mid-to-late 1990s, however, glyphosate-resistant crops were

introduced to farmers and rapidly gained market share. ER 161, 257, 391. This

triggered a dramatic increase in the application of glyphosate-based herbicides. ER

161-63, 391-92. In 1995, before the introduction of glyphosate-resistant crops,

agricultural use of glyphosate totaled under 28 million pounds; by 2014,

agricultural use of glyphosate skyrocketed to nearly 250 million pounds—an

approximate tenfold increase. ER 391.

Glyphosate use has already decimated a substantial portion of the milkweed

on which monarchs rely. ER 164-66, 267, 320-21. Milkweed loss, particularly in

the Midwest, has been well documented, and is in large part attributed to increased

glyphosate use. ER 257, 266. A survey of milkweed in Iowa corn and soybean

fields in 1999 found milkweed in at least 50 percent of the fields. ER 257. By

2009, milkweed was recorded in only 8 percent of the fields. Id. Additionally, the


17

overall area occupied by milkweed within the fields decreased by 90 percent. Id.

Relying on these and other data, one study extrapolated the loss of milkweed in

both agricultural and non-agricultural areas across the entire Midwest and found a

58 percent decline in milkweed from 1999 to 2010. ER 266, 270.

The extensive loss of milkweed has devastated the monarch population. ER

166-73. The Midwest, in particular, constitutes a significant portion of the

monarchs’ migratory pathway. ER 229, 303-04. Fifty percent of monarchs that

overwinter in Mexico feed on Midwestern milkweed as caterpillars, so reduced

milkweed availability in this region has significant effects on the population. ER

229. Furthermore, monarchs tend to lay more eggs in agricultural areas than in

non-agricultural areas. ER 239, 273. The decline of milkweed in the agricultural

Midwest has thereby caused a greater-than-proportional reduction in monarch

reproduction. See ER 168, 266, 273. Between 1999 and 2010, monarch

reproduction in the Midwest declined by 81 percent. ER 266, 273.

Decreased monarch reproduction has caused the monarch population to

plummet. See ER 168-69. During the same period that herbicide-resistant crops

became prevalent in the United States, leading to rapidly accelerating herbicide use

and milkweed loss, there has been a dramatic, corresponding decline in the

overwintering monarch population in Mexico. ER 168-69, 266-73. That population

dropped from a high of nearly 700 million butterflies in 1997 to a low of


18

approximately 25 million butterflies in 2014.6 ER 377, 382. While interannual

variation in the population size is expected, the long-term trend of decline is clear.

See ER 403, 409-11.

It is widely acknowledged among monarch experts that a driving force

behind the butterfly’s decline is milkweed loss in the United States caused by

widespread use of herbicides, particularly those containing glyphosate, on

herbicide-resistant crops. See ER 168-70; 319-22, 2191-92; see, e.g., ER 257-58;

261-62; 267, 303-04, 360-65, 403. A 2014 study examining the relative magnitude

of different threats to monarchs found that “[r]ecent population declines stem from

reduction in milkweed host plants in the United States that arise from increasing

adoption of genetically modified crops and land-use change, not from climate

change or degradation of forest habitats in Mexico.” ER 297. The study concluded

that “conserving monarch butterflies by addressing the negative impacts of

changing land-use and the adoption of genetically-modified, herbicide-resistant

crops on host plant abundance is the highest conservation priority.” ER 304.

6 The number of monarchs overwintering in Mexico is estimated by

multiplying the total number of hectares occupied by the butterflies by their density per hectare. ER 377. Monarchs occupied 18.19 hectares of forest during the winter of 1996-1997 compared with .67 acres in the winter of 2013-2014. Id. The density of overwintering monarchs was recently estimated at 37.5 million butterflies per hectare. ER 382. To the extent that NRDC’s comments used an older density estimate to calculate overwintering population size, the population estimates in the comments differ from those in this brief. See, e.g., ER 159.


19

EPA’s registration of Enlist Duo poses a significant risk to the beleaguered

monarch population, threatening to drive it towards collapse. Enlist Duo is

intended to suppress milkweed, and both 2,4-D and glyphosate are toxic to

milkweed. ER 112, 158-60, 321-322. EPA’s approval of Enlist Duo for use on

herbicide-resistant crops is particularly problematic for monarchs. Herbicides are

applied more frequently, and at higher rates, when used on herbicide-resistant

crops. ER 320-21; see, e.g., ER 28. In addition, herbicides that cause limited

damage to target plants when applied at lower rates are often much more damaging

when sprayed at higher rates. ER 321. Furthermore, milkweed tends to regrow

when it is mowed, damaged by tilling, or treated with herbicides that are applied

before milkweed shoots emerge in late spring. ER 320. But when herbicides are

paired with herbicide-resistant crops, they can be applied later in the growing

season during the milkweed plant’s most vulnerable flowering stage. Id.

The final, approved label for Enlist Duo recommends application “when

most [common milkweed] plants have reached the late bud to flower stage of

growth,” thereby reducing the chances that affected plants can recover and regrow.

ER 112; see ER 320. Compounding the risk to monarchs, EPA registered Enlist

Duo for use in thirty-four states that fall directly within the pathway of migrating

butterflies. Compare ER 2, with ER 212-14, 229.


20

The migrating monarch population is already so diminished that its

prospects for recovery are fading. ER 171-73. Continued milkweed loss renders the

population susceptible to further decline, compromising its ability to withstand

additional stressors such as severe weather, freezing temperatures, disease,

predation, and deforestation. See ER 223, 262-63. In 2002, a single storm killed

more than 450 million monarchs, which constituted approximately 75 percent of

the overwintering population—and exceeded, by over three times, the 150 million

monarchs overwintering in Mexico during the 2015-2016 season. See ER 252;

compare ER 382 (estimating overwintering monarch population density of 37.5

million butterflies per hectare), with ER 409-11 (reporting that overwintering

monarchs occupied 4.01 hectares during the 2015-2016 winter season).

Severe storms occur periodically, leaving the diminished monarch

population in a precarious state. In 2004, another serious storm killed about 70

percent of the overwintering monarch population, with casualties far exceeding the

total number of monarchs overwintering in Mexico during the recent 2015-2016

season. Compare ER 409 (reporting that overwintering monarch colonies occupied

approximately 8 to 11.12 hectares during the 2003-2004 winter season, but only

4.01 hectares during the 2015-2016 winter season), with ER 412. Subsequently, a

2010 storm killed approximately 50 percent of the monarchs overwintering in

Mexico. ER 262-63. Owing to its current size, the monarch population is


21

susceptible to complete eradication by comparable storms. ER 1097-1098; see also

ER 406 (explaining that “tightly clustered overwintering colonies convey

important microclimate advantages that diminish as colony size decreases,” so that

“[d]iminishing colony size can therefore result in higher winter mortality rates”).

The smaller the population becomes, the more vulnerable it is to these kinds of

natural events. ER 172-73, 1098.

Continued suppression of milkweed across the butterflies’ breeding grounds

perpetuates the risk of monarch population collapse, and additional milkweed

destruction exacerbates that risk. ER 172-73. The population is so precariously

small that experts—including those at the Department of Agriculture—have

warned that the monarch migration may be coming to an end. See, e.g., ER 263,

279-80, 405-06. In 2016, a group of academic researchers and scientists from

federal and state agencies jointly published a study finding that migrating eastern

monarchs face a “high probability of quasi-extinction [that is, population collapse]

over the next two decades.” ER 405. “Given the population’s present low

numbers,” the study concluded, “poor reproductive success by monarchs in future

breeding seasons due to weather conditions and reduced breeding habitat, followed

by catastrophic mortality while over-wintering in Mexico, could bring the monarch

migration to the brink of extinction.” Id.


22

III. Enlist Duo may pose serious risks to human health

There is a growing body of published scientific literature suggesting that

exposure to either of Enlist Duo’s active ingredients may cause significant human

health risks. Glyphosate is the most widely used pesticide in the country, with

about 250 million pounds applied to fields each year. ER 347, 391. People can be

exposed to glyphosate on or near the many farms where the pesticide is used, as

well as when they eat food, or drink water, contaminated with glyphosate. See ER

179-80, 3158-60, 3180 n.56.

Recent studies link exposure to glyphosate and glyphosate products to

serious health harms, including kidney damage, birth defects, pre-term deliveries,

miscarriages, and neural tube defects. See, e.g., ER 173-74 & nn. 134-35, 176-77,

462-63; see also ER 515-16 (former EPA senior research scientist expressing

concern about glyphosate’s health risks, including its potential for endocrine

disruption). Although EPA recently concluded that glyphosate is not likely to be

carcinogenic to humans, ER 53, the agency registered Enlist Duo without

considering new, peer-reviewed literature on glyphosate’s non-cancer health risks

highlighted by commenters, including NRDC. See ER 3 (refusing to conduct any

new assessment for glyphosate); see, e.g., ER 173-74 & nn. 134-35, 176-77.

2,4-D’s exposure pathways are similar to glyphosate’s; they include food

residues, contaminated drinking water, spray drift, and vapor residues emitted from


23

treated fields. See ER 11-12, 14-16, 190-95. As with glyphosate, there are many

published studies implicating 2,4-D in significant human health risks, such as

thyroid problems and Non-Hodgkin lymphoma. ER 183-87, 463, 466-67. Although

EPA concluded that 2,4-D does not present significant health risks, the agency’s

analyses are flawed. EPA disregarded evidence of 2,4-D’s carcinogenicity and

thyroid toxicity, and underestimated individuals’ aggregate exposures to 2,4-D. ER

182-97, 463-67. The agency did not fully account for health risks posed by the

2,4-D in Enlist Duo, particularly to pregnant women and children. ER 188-97.

IV. Procedural history

EPA’s current order registering Enlist Duo supersedes two previous

registration orders of more limited scope. Compare ER 1-2, 5, 37, with ER 1371-

72, 1401, and ER 1019, 1055-56.

A. EPA’s previous registration orders (2014 and 2015)

On October 15, 2014, EPA issued a final order registering Enlist Duo for use

on Enlist Duo-resistant corn and soybeans in six states.7 ER 1371-72, 1394, 1400.

EPA’s decisional documents were unclear as to whether the registration was

unconditional or conditional.8 Because EPA failed to consider harm to monarchs

7 Those states are Illinois, Indiana, Iowa, Ohio, South Dakota, and

Wisconsin. ER 1400. 8 Although the agency’s Final Registration Decision referenced FIFRA’s

provision for conditional amendment, the Notice of Registration that EPA


24

and to fully evaluate glyphosate’s health risks before registering Enlist Duo,

NRDC petitioned this Court for review of EPA’s order. Petition for Review,

NRDC v. EPA, No. 14-73353 (9th Cir. Oct. 30, 2014), ECF No. 1-1; see ER 1372,

1436. The Center for Food Safety and other petitioners (CFS Petitioners) also

challenged EPA’s registration order on other grounds. Petition for Review, CFS v.

EPA, No. 14-73359 (9th Cir. Oct. 30, 2014), ECF No. 1-2.

On March 31, 2015, EPA issued a second final order amending the

registration of Enlist Duo to allow use on Enlist Duo-resistant corn and soybeans in

nine additional states.9 See ER 1055-56. Because EPA still had not examined harm

to monarchs or fully assessed glyphosate’s health risks, NRDC filed an additional

petition for review challenging the amended registration order. Petition for

Review, NRDC v. EPA, No. 15-71213 (9th Cir. Apr. 20, 2015), ECF No. 1-2. CFS

Petitioners also filed an additional petition for review challenging this amended

order. Petition for Review, CFS v. EPA, No. 15-71207 (9th Cir. Apr. 20, 2015),

ECF No. 1-2.

concurrently issued deemed the registration unconditional. Compare ER 1394, with ER 1401. In defending the registration in litigation, EPA characterized the registration as unconditional. See, e.g., Resp’ts’ Mot. for Voluntary Vacatur and Remand at 3-4, NRDC v. EPA, No. 14-73353 (9th Cir. Nov. 24, 2015), ECF No. 121-1.

9 Those states are Arkansas, Kansas, Louisiana, Minnesota, Mississippi, Missouri, Nebraska, North Dakota, and Oklahoma. ER 1056.


25

While the cases were pending, EPA discovered that Dow had filed an

application with the U.S. Patent and Trademark Office claiming synergism

between 2,4-D and glyphosate. ER 2-3. This discovery prompted the agency to

concede that it “could no longer represent to the Court that its conclusions were

correct regarding whether issuance of the registration met the standard in FIFRA.”

ER 3. Accordingly, EPA moved for remand and vacatur of the registration. Id.

Dow opposed vacatur. See Resp. to Resp’ts’ Mot. for Voluntary Vacatur and

Remand at 2, NRDC v. EPA, No. 14-73353 (9th Cir. Dec. 7, 2015), ECF No. 122.

On January 25, 2016, the Court granted the motion for remand but denied vacatur.

ER 3.

B. EPA’s current registration order (2017)

On October 31, 2016, EPA issued a new proposal to register Enlist Duo on

Enlist Duo-resistant corn, soybeans, and cotton in thirty-four states. ER 521, 523.

EPA invoked FIFRA’s conditional registration provision generally, without

specifying which of the three types of conditional registration it was considering.

See ER 549. In addition, the agency explained that it had assessed some of the

anticipated risks from the expanded use of 2,4-D that the registration would cause,

but concluded that “no new assessment is needed for glyphosate” because “no new

use patterns and no new exposures for glyphosate are being considered with this

registration action.” ER 522. EPA provided no indication that it had ever


26

considered 2,4-D’s or glyphosate’s potential to harm monarchs by destroying

milkweed, or that it had evaluated recent literature on glyphosate’s health risks.

NRDC timely submitted comments opposing the proposed registration on

December 1, 2016. ER 144-211. In its comments, NRDC asserted that EPA may

not conditionally register Enlist Duo, and explained that EPA must, consistent with

FIFRA’s unconditional registration provision, undertake the full range of analyses

necessary to determine whether the registration would cause unreasonable adverse

impacts on human health and the environment.10 ER 206-11; see 7 U.S.C.

§ 136a(c)(5). The comments underscored EPA’s obligation to “consider the

substantial adverse impacts that Enlist Duo will have on monarch butterflies,

insofar as both glyphosate and 2,4-D destroy milkweed, which is critical to the

monarch life cycle.” ER 151; see ER 158-73. In addition, the comments called on

EPA to “complete an updated assessment of glyphosate’s human health risks.” ER

151. NRDC urged EPA to consider recent studies that had been published on

glyphosate’s health effects, including studies suggesting that glyphosate may cause

kidney toxicity and birth defects. ER 173-78. Other commenters likewise requested

10 NRDC’s comments assumed that EPA was proposing to register Enlist

Duo under § 136a(c)(7)(A) and explained why registration under that provision would be unlawful. ER 206-11. As described below, EPA ultimately relied on a different conditional registration provision, § 136a(c)(7)(B), to register Enlist Duo; the agency specified this choice for the first time in its Final Registration Decision. See ER 4, 30.


27

that EPA assess Enlist Duo’s effects on monarch habitat and evaluate up-to-date

science on glyphosate’s health risks. See ER 484 (incorporating previous CFS

comments); see, e.g., ER 462-65, 515-16, 1714-22, 2191-92.

Disregarding these comments, EPA issued its third final order

registering Enlist Duo on January 12, 2017. Mirroring the proposed order,

the final order included “three new decisions”:

First, EPA is issuing a new decision on the currently registered Enlist DuoTM for use on GE soybean and corn in 15 states, following the remand decision . . . . Second, the EPA is granting the approval of Enlist DuoTM for use on GE soybean and corn in an additional 19 states.[11] Third, EPA is granting a new use for Enlist DuoTM on GE cotton in 34 states (corresponding with the 15 states previously registered [sic], plus the 19 additional states approved for use of Enlist DuoTM on GE corn and soybean).

ER 2. Together, the three decisions registered Enlist Duo for use on Enlist

Duo-resistant corn, soybeans, and cotton in thirty-four states. See id.

Despite expressly characterizing these decisions as registration

decisions for Enlist Duo, EPA simultaneously insisted that it was merely

registering new uses of 2,4-D on 2,4-D-resistant corn, soybeans, and cotton.

See ER 1-4, 29. The agency emphasized that the “application in front of

11 Those states are Alabama, Arizona, Colorado, Delaware, Florida, Georgia,

Kentucky, Maryland, Michigan, North Carolina, New Jersey, New Mexico, New York, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and West Virginia. ER 2.


28

EPA is for a new use for 2,4-D choline salt” and that “this new use action is

specific to the 2,4-D.” ER 3-4. As before, EPA maintained that it was “not

taking any action as it relates to the glyphosate component of Enlist Duo.”

ER 4. Because “Enlist DuoTM uses on GE corn, soybeans, and cotton are

already registered on other glyphosate products,” EPA averred, “no new use

patterns and no new exposures for glyphosate are being considered” and “no

new assessment is needed for glyphosate.” ER 3.

To justify its decisions, EPA haphazardly referenced three different

FIFRA registration standards. ER 4, 28-30. First, the agency asserted that it

“only registers a pesticide when it determines that it will not cause

unreasonable adverse effects on man or the environment.” ER 28. This is a

criterion specific to the unconditional registration standard. See 7 U.S.C.

§ 136a(c)(5)(C). The order concluded that both glyphosate (based on data

from preexisting pesticide registrations) and 2,4-D (based on currently

available data), meet this criterion. See ER 4, 28-29. It is ambiguous whether

EPA determined that Enlist Duo, as a whole, likewise meets this criterion.

See ER 30 (concluding that “registering these uses will not generally cause

unreasonable adverse effects on human health or the environment,” but not

specifying whether “these uses” refer to the new uses of 2,4-D, Enlist Duo,

or both).


29

In addition, EPA referenced two different conditional registration

standards to explain its new decisions. EPA purported to treat the glyphosate

component of Enlist Duo “as if it were” a registration under § 136a(c)(7)(A).

ER 3 & n.3, 4; see 7 U.S.C. § 136a(c)(7)(A) (allowing EPA to conditionally

register, or conditionally amend an existing registration for, any pesticide or

proposed use that is “identically or substantially similar to any currently

registered pesticide and use thereof”). The agency qualified, however, that it

was not actually relying on that provision to register either glyphosate or

Enlist Duo. ER 3-4.

At the same time, EPA stated that it was registering the 2,4-D

component of Enlist Duo under a different conditional registration provision,

§ 136a(c)(7)(B). ER 4. Ultimately, EPA also indicated that it was registering

Enlist Duo under § 136a(c)(7)(B). ER 30. But not once did the agency

explicitly address whether registration of Enlist Duo would “significantly

increase the risk of any unreasonable adverse effect on the environment,” as

required for registration under that provision. 7 U.S.C. § 136a(c)(7)(B). Of

particular concern here, EPA neglected to consider Enlist Duo’s potential to

harm monarch butterflies through its suppression of milkweed, and the

agency ignored new evidence of glyphosate’s human health risks.


30

On March 21, 2017, NRDC filed a petition for review in this Court

challenging the registration. Case No. 17-70817, ECF No. 1-5. That same

day, a group of petitioners led by the National Family Farm Coalition filed a

separate petition for review challenging the registration. Case No. 17-70810,

ECF No. 1-2. The Court consolidated the two lawsuits. Case No. 17-70810,

ECF No. 14.

SUMMARY OF ARGUMENT

I. EPA violated FIFRA by registering Enlist Duo, a new pesticide, under

§ 136a(c)(7)(B), even though that provision authorizes EPA only to “amend”

existing registrations. 7 U.S.C. § 136a(c)(7)(B). To escape the plain meaning of the

statute, EPA treated the application to register Enlist Duo as though it were simply

an application to amend an existing registration of one of Enlist Duo’s two active

ingredients: 2,4-D. But even if EPA may amend an existing registration of 2,4-D

under § 136a(c)(7)(B), this does not mean that the agency may register Enlist Duo,

a new pesticide, under the same provision. EPA fails to provide a reasonable

explanation for how the plain language of § 136a(c)(7)(B) permits the agency to

register the inaugural uses of Enlist Duo.

In addition, EPA may not rely on § 136a(c)(7)(B) to avoid assessing all

available, relevant information on the full range of Enlist Duo’s risks. Section

136a(c)(7)(B) requires EPA to assess only the incremental risks associated with the


31

additional uses of a previously registered pesticide, based on data specific to those

additional uses. See id. In contrast, unconditional registration requires EPA to

comprehensively assess all of a pesticide’s risks, based on data sufficient to inform

that thorough analysis. See id. § 136a(c)(5); 40 C.F.R. §§ 152.112(c), 158.75. To

grant an unconditional registration, EPA must determine—based on all relevant

data before the agency—that Enlist Duo would not cause “unreasonable adverse

effects” on human health or the environment.12 7 U.S.C. § 136a(c)(5)(C), (D); see

40 C.F.R. § 152.112(b), (e).

Here, EPA evaded the analysis for unconditional registration through its

improper reliance on § 136a(c)(7)(B). The agency refused even to consider

pertinent, recent studies indicating that glyphosate may cause serious human health

harms such as kidney toxicity and birth defects. Similarly, despite having never

assessed, in relation to any prior pesticide application, glyphosate’s potential to

harm monarchs by destroying milkweed, EPA declined to consider the weighty

evidence that NRDC and others put before the agency substantiating this harm.

II. In the alternative, even if EPA may conditionally register the very first uses

of Enlist Duo under § 136a(c)(7)(B), the agency must first determine that those

uses “would not significantly increase the risk of any unreasonable adverse effect

12 EPA must also make other determinations that are not relevant here. See 7

U.S.C. § 136a(c)(5).


32

on the environment” beyond the risks posed by currently registered pesticides

containing 2,4-D or glyphosate. 7 U.S.C. § 136a(c)(7)(B).

In public comments, NRDC and others timely notified EPA of extensive

evidence that use of herbicides on herbicide-resistant crops has been a dominant

cause of monarch-habitat destruction and resulting population decline. 2,4-D kills

milkweed, and EPA recognized that registering Enlist Duo for new uses on 2,4-D-

resistant crops will expand overall use of 2,4-D. The agency nonetheless failed to

assess how Enlist Duo’s expanded uses of 2,4-D would affect milkweed and

monarchs. In addition, EPA ignored evidence that registration of Enlist Duo for

use on glyphosate-resistant crops will bolster widespread use of glyphosate, insofar

as the novel combination of 2,4-D and glyphosate in Enlist Duo will stave off

rapidly spreading weed-resistance to glyphosate that would otherwise limit

glyphosate’s efficacy. Because Enlist Duo is likely to reinvigorate glyphosate use,

EPA must consider glyphosate’s potential to harm milkweed and monarchs, and to

adversely affect human health—concerns repeatedly identified in recent scientific

literature that EPA failed to consider.

By declining to assess evidence of Enlist Duo’s incremental impacts on

monarchs and human health, EPA lacked substantial evidence to conclude that

registration of Enlist Duo “would not significantly increase the risk of any


33

unreasonable adverse effect on the environment.” 7 U.S.C. § 136a(c)(7)(B). The

registration should therefore be vacated.

STANDARD OF REVIEW

Under FIFRA, a pesticide-registration order “shall be sustained if it is

supported by substantial evidence when considered on the record as a whole.” 7

U.S.C. § 136n(b). “Substantial evidence means more than a mere scintilla but less

than a preponderance; it is such relevant evidence as a reasonable mind might

accept as adequate to support a conclusion.” NRDC v. EPA (Nanosilver II), 857

F.3d 1030, 1036 (9th Cir. 2017) (quoting NRDC v. EPA (Nanosilver I), 735 F.3d

873, 877 (9th Cir. 2013)). “Although the substantial evidence standard of review is

relatively deferential to the agency factfinder, [the Court’s] review still must be

searching and careful, subjecting the agency’s decision to close judicial scrutiny.”

Containerfreight Corp. v. United States, 752 F.2d 419, 422 (9th Cir. 1985)

(internal quotation marks omitted).

To the extent that the “substantial evidence” test differs from arbitrary-and-

capricious review under the Administrative Procedure Act, “Congress expected

greater scrutiny when the enabling statute contains a substantial evidence test.”

Union Oil Co. of Cal. v. Fed. Power Comm’n, 542 F.2d 1036, 1041 (9th Cir.

1976). Consequently, “if the EPA’s pesticide registration is arbitrary and


34

capricious, the EPA cannot show it was supported by substantial evidence.”

Pollinator Stewardship Council, 806 F.3d at 1188 (Smith, N.R., J., concurring).

To survive the arbitrary-and-capricious test, and hence substantial-evidence

review, an “agency must examine the relevant data and articulate a satisfactory

explanation for its action including a ‘rational connection between the facts found

and the choice made.’” Motor Vehicle Mfrs. Ass’n of U.S. v. State Farm Mut. Auto.

Ins. Co., 463 U.S. 29, 43 (1983) (quoting Burlington Truck Lines v. United States,

371 U.S. 156, 168 (1962)). An agency’s decision cannot be supported by

substantial evidence if the agency failed to consider adequate relevant data. See

Pollinator Stewardship Council, 806 F.3d at 532. (“Without sufficient data, the

EPA has no real idea whether sulfoxaflor will cause unreasonable adverse effects

on bees, as prohibited by FIFRA. Accordingly, the EPA’s decision to register

sulfoxaflor was not supported by substantial evidence.”). Nor can the agency meet

this standard if it “entirely failed to consider an important aspect of the problem.”

State Farm, 463 U.S. at 43; accord Mont. Wilderness Ass’n v. McAllister, 666 F.3d

549, 555, 558, 561 (9th Cir. 2011). Further, “[i]t is well-established that an

agency’s action must be upheld, if at all, on the basis articulated by the agency

itself.” Nanosilver II, 857 F.3d at 1036 (alteration in original) (quoting Nanosilver

I, 735 F.3d at 877).


35

ARGUMENT

I. EPA’s registration of Enlist Duo is unlawful because FIFRA does not authorize EPA to register a new pesticide under § 136a(c)(7)(B)

Section 136a(c)(7)(B)’s grant of authority to EPA is narrow: the agency may

only “amend” existing pesticide registrations conditionally to “permit additional

uses.” 7 U.S.C. § 136a(c)(7)(B). Enlist Duo is a new pesticide, never before

registered. For this reason, it is not eligible for amended registration under

§ 136a(c)(7)(B).

A. EPA’s registration of Enlist Duo contravenes the plain text of § 136a(c)(7)(B)

“The preeminent canon of statutory interpretation requires [courts] to

presume that [the] legislature says in a statute what it means and means in a statute

what it says there.” L.A. Lakers, Inc. v. Fed. Ins. Co., 869 F.3d 795, 802 (9th Cir.

2017) (second alternation in original) (internal quotation marks omitted).

Section 136a(c)(7)(B) plainly states that EPA may “conditionally amend the

registration of a pesticide to permit additional uses of such pesticide.” 7 U.S.C.

§ 136a(c)(7)(B) (emphases added). In accordance with the ordinary meaning of

those terms, EPA cannot “amend” the registration of “a pesticide,” or add

“additional uses” to the registration of “such pesticide,” if there is no lawful

registration of that pesticide in the first place. See Yith v. Nielsen, 881 F.3d 1155,

1165 (9th Cir. 2018) (“[U]nless otherwise defined, words will be interpreted as


36

taking their ordinary, contemporary, common meaning.”); 7 U.S.C. § 136

(providing no definition for “amend” or “additional”). This means that new

pesticides do not qualify for registration under § 136a(c)(7)(B).

As a novel mixture of glyphosate, 2,4-D, and various inert ingredients, Enlist

Duo is a new pesticide. See 7 U.S.C. § 136(u) (defining pesticide as “any substance

or mixture of substances intended for preventing, destroying, repelling, or

mitigating any pest”). The registration challenged here is the only operative

registration for Enlist Duo, because it supersedes EPA’s earlier registration orders,

which this Court remanded to the agency. See ER 3; Resp’ts’ Opp’n to Pet’rs’ Mot.

to Adjudicate Pending Claims or, in the Alternative, to Stay the Mandate and

Retain Jurisdiction at 8-9, NRDC v. EPA, No. 14-73353 (9th Cir. Mar. 21, 2016),

ECF No. 130-1 (conveying EPA’s intent that the previous registration orders be

fully incorporated into, or replaced by, the new final registration order issued by

the agency following remand); compare ER 1-2, 5, 37 (2017 final registration

documents), with ER 1371-72, 1401 (2014 final registration documents), and ER

1019, 1055-56 (2015 final registration documents). There is thus no valid,

preexisting registration of Enlist Duo for EPA to “amend.” Similarly, because there

are no lawful, previously approved uses of Enlist Duo, the new uses approved by

EPA do not qualify as “additional uses” of the pesticide. As a consequence, EPA

may not register Enlist Duo under § 136a(c)(7)(B).


37

It is a “core administrative-law principle that an agency may not rewrite

clear statutory terms to suit its own sense of how the statute should operate.” Util.

Air Regulatory Grp. v. EPA, 134 S. Ct. 2427, 2446 (2014); see also id. at 2445.

Defying this fundamental principle, EPA has essentially rewritten § 136a(c)(7)(B)

to say:

The Administrator may conditionally amend grant the registration of a pesticide to permit additional uses of such pesticide notwithstanding that data concerning the pesticide may be insufficient to support an unconditional amendment registration, if the Administrator determines that (i) the applicant has submitted satisfactory data pertaining to the proposed additional use, and (ii) amending granting the registration in the manner proposed by the applicant would not significantly increase the risk of any unreasonable adverse effect on the environment.

7 U.S.C. § 136a(c)(7)(B). “[T]he need to rewrite clear provisions of the statute

should have alerted EPA that it had taken a wrong interpretive turn.” Util. Air

Regulatory Grp., 134 S. Ct. at 2446. Instead, EPA ignored the plain language of

§ 136a(c)(7)(B) and proceeded to register Enlist Duo under its distorted

interpretation of that provision.

“An agency,” however, “has no power to ‘tailor’ legislation to bureaucratic

policy goals by rewriting unambiguous statutory terms.” Id. at 2445. Here,

FIFRA’s plain text forecloses EPA from relying on § 136a(c)(7)(B) to register

Enlist Duo. Because the Court’s “inquiry begins with the statutory text, and ends

there as well,” the registration is unlawful and must be nullified. Nat’l Ass’n of


38

Mfrs. v. Dep’t of Def., 138 S. Ct. 617, 631 (2018); see also Benitez v. Califano, 573

F.2d 653, 655 (9th Cir. 1978) (holding that regardless of whether an agency’s

findings are supported by substantial evidence, a decision “should be set aside if

the proper legal standards were not applied in weighing the evidence and making

the decision”).

B. EPA fails to provide a reasonable explanation that reconciles its registration of Enlist Duo with the plain text of § 136a(c)(7)(B)

EPA attempts to circumvent § 136a(c)(7)(B)’s plain inapplicability to Enlist

Duo by claiming that the “new use . . . being conditionally registered under FIFRA

section 3(c)(7(B) [sic]” is merely “a new use for 2,4-D choline salt.” ER 4; see ER

29. But both EPA’s Final Registration Decision and its Notice of Registration state

that the agency registered “Enlist Duo”—and not “2,4-D Choline Salt.” ER 1, 37.

Simply put, Enlist Duo is not 2,4-D. EPA may not claim that it registered only new

uses of the active ingredient 2,4-D when it actually registered new uses of Enlist

Duo, a distinct and novel pesticide. See 7 U.S.C. § 136(u). That EPA voluntarily

moved to remand and vacate its previous registrations of Enlist Duo to scrutinize

potential synergistic effects between the pesticide’s active ingredients underscores

that a pesticide containing multiple active ingredients must be evaluated as an

integrated unit, and confirms that it is Enlist Duo, and not just 2,4-D, that is a

subject of this registration. See ER 4-5, 23-24, 54-56, 66-69. Despite the agency’s

attempted sleight-of-hand, the “pesticide” at issue in this § 136a(c)(7)(B) analysis


39

is Enlist Duo, and the phrases “a pesticide” and “such pesticide” in that provision

must refer to Enlist Duo. 7 U.S.C. § 136a(c)(7)(B).

Although EPA could “conditionally amend the registration of [Enlist Duo]

to permit additional uses of [Enlist Duo]” after Enlist Duo has already been

lawfully registered, EPA may not rely on § 136a(c)(7)(B) to register Enlist Duo in

the first instance. Id. If, as EPA represents, “the application in front of EPA is for a

new use for 2,4-D choline salt”—and if, as EPA asserts, it “only assess[ed] the

risks and benefits of the active ingredient [2,4-D choline salt]”—then the

registration EPA granted should have been limited to “a new use for 2,4-D choline

salt,” and not extended to the inaugural use of Enlist Duo. ER 3, 4.

“[A]n agency’s action must be upheld, if at all, on the basis articulated by

the agency itself.” Nanosilver II, 857 F.3d at 1036 (quoting Nanosilver I, 735 F.3d

at 877). Here, EPA failed to explain how its registration of Enlist Duo under

§ 136a(c)(7)(B) can be squared with the plain text of that provision.13 The

convoluted reasoning that EPA offered to support its decisions—mixing and

matching elements of three different registration standards to justify the agency’s

diverging approaches to the 2,4-D component of Enlist Duo, the glyphosate

component of Enlist Duo, and Enlist Duo herbicide overall—goes further to show

13 Nor has EPA attempted to demonstrate that there is substantial evidence to

support registration of Enlist Duo under any other FIFRA registration provision.


40

that EPA cannot articulate an interpretation of § 136a(c)(7)(B) that permits it to

register Enlist Duo. See supra Statement of the Case IV.B.

C. EPA’s misguided approach to § 136a(c)(7)(B) undermines FIFRA’s core purpose because it allows new pesticides on the market without adequate assessment of their risks

FIFRA aims “to protect against the risk of harm from pesticide products.”

Sultan Chemists, Inc. v. EPA, 281 F.3d 73, 83 (3d Cir. 2002). EPA’s unlawful

reliance on § 136a(c)(7)(B) has the practical consequence of allowing the agency

to defer evaluating evidence relating to the full range of Enlist Duo’s risks, in

defiance of the statute’s fundamental purpose. In particular, EPA relied on

§ 136a(c)(7)(B) to ignore evidence before the agency regarding the glyphosate

component of Enlist Duo.14

Section 136a(c)(7)(B) instructs EPA to determine whether “amending the

registration” of a pesticide to grant additional uses will “significantly increase the

risk of any unreasonable adverse effect” on human health and the environment. 7

U.S.C. § 136a(c)(7)(B); see id. § 136(bb). Under this standard, the agency

evaluates only the incremental increase in risk created by a pesticide’s additional

14 Although EPA also disregarded evidence relating to risks posed by the

2,4-D in Enlist Duo, the agency did not attempt to justify its failure to consider that evidence through its reliance on § 136a(c)(7)(B). Instead, the agency simply glossed over the omission without providing any responsive explanation. See infra Argument II.A.


41

uses—and does so based on the limited set of data pertinent to that incremental

risk. By contrast, when EPA unconditionally registers a new pesticide, the agency

conducts a comprehensive assessment of all risks of unreasonable adverse effects

posed by the pesticide. See id. § 136a(c)(5). This assessment requires EPA to

evaluate “all relevant data in the possession of the Agency.” 40 C.F.R.

§ 152.112(b); accord Pollinator Stewardship Council, 806 F.3d at 528. Through its

unlawful invocation of § 136a(c)(7)(B), EPA selected a narrower scope for its risk

assessment than would be required for unconditional registration, both in terms of

the breadth of the risks evaluated and the range of the data necessary to support

that analysis.

As a result, EPA ignored critical evidence of risks posed by Enlist Duo.

NRDC presented EPA with overwhelming evidence that the glyphosate in Enlist

Duo harms monarchs by killing milkweed. See supra Statement of the Case II; ER

15-30. NRDC also referred EPA to new peer-reviewed studies indicating that

glyphosate may cause serious health risks, including kidney toxicity and birth

defects. See supra Statement of the Case III. EPA had never evaluated this

information in connection with any previous registration of a glyphosate-

containing pesticide. Yet, the agency refused to consider this new evidence of

glyphosate’s harms before registering Enlist Duo. See ER 3-4. EPA did not find

that the new data were irrelevant or not credible. Instead, it claimed that registering


42

Enlist Duo would not significantly affect glyphosate use,15 and thus no new risk

analysis of glyphosate was necessary. See id.

But had EPA used the § 136a(c)(5) standard for unconditional registration to

assess Dow’s application to register Enlist Duo, the agency could not have ignored

new, “relevant data in the possession of the Agency,” 40 C.F.R. § 152.112(b)—

even if EPA were correct that Enlist Duo would not materially change overall

glyphosate use. While EPA certainly could have drawn on past assessments of

glyphosate, see 7 U.S.C. § 136a(c)(1)(F), the agency could not disregard new data

before it about glyphosate’s health and environmental harms. Compare ER 3-4,

with ER 1438 (“Proposed new registrations are held to the most current data

requirements and up-to-date risk assessment practices and must meet the FIFRA no

unreasonable adverse effects standard to be registered.”).

Affirming EPA’s misuse of § 136a(c)(7)(B) would allow the agency to defer

evaluating relevant evidence of Enlist Duo’s risks, thereby undermining the

statute’s core purpose to prevent unreasonable harm from pesticide use. See Cty. of

Amador v. U.S. Dep’t of Interior, 872 F.3d 1012, 1022 (9th Cir. 2017) (noting that

a statute should be interpreted with respect to its purpose); Sultan Chemists, 281

F.3d at 83; N.Y. State Pesticide Coal., Inc. v. Jorling, 874 F.2d 115, 117 (2d Cir.

15 As discussed below, this determination is not supported by substantial

evidence. See infra Argument II.B.


43

1989) (explaining that Congress passed FIFRA to protect humans and the

environment from the “deleterious effects” of pesticides); see also 7 U.S.C.

§ 136a(a) (authorizing EPA to restrict the sale or distribution of any unregistered

pesticide “[t]o the extent necessary to prevent unreasonable adverse effects on the

environment”); Ma v. Ashcroft, 361 F.3d 553, 558 (9th Cir. 2004) (stating that

statutory interpretations producing absurd results are to be avoided).

II. EPA’s registration of Enlist Duo under § 136a(c)(7)(B) is not supported by substantial evidence because EPA failed adequately to consider increased risk of harm to monarch butterflies and human health

In the alternative, even if FIFRA allows EPA to conditionally register new

uses of Enlist Duo under § 136a(c)(7)(B) in the atextual manner proposed, the

agency must still determine that the registration “would not significantly increase

the risk of any unreasonable adverse effect on the environment.” 7 U.S.C.

§ 136a(c)(7)(B). EPA lacked substantial evidence to conclude that Enlist Duo

satisfies this criterion,16 because it ignored evidence that the pesticide’s new uses

of 2,4-D would harm the imperiled monarch population through destruction of

additional milkweed habitat; as well as evidence that the registration would bolster

glyphosate use and the associated risks to milkweed and monarchs, and to human

health.

16 If EPA reached this conclusion for Enlist Duo, as opposed to just 2,4-D, it

did so implicitly rather than explicitly. See ER 28-30. For the sake of this argument in the alternative, Petitioners assume that the agency did reach this conclusion.


44

A. EPA declined to assess harm to milkweed and monarchs from Enlist Duo’s expansion of 2,4-D use

In public comments on EPA’s proposed decisions to register Enlist Duo,

NRDC and others brought to the agency’s attention an extensive body of scientific

literature documenting the significant decline of the North American monarch

butterfly population. See ER 159, 164-73, 319-20. The comments alerted EPA to

the considerable risk that Enlist Duo poses to monarchs, and specifically noted that

this risk arises in part from Enlist Duo’s inclusion of 2,4-D, which kills the

milkweed that monarchs need to survive. ER 158-73, 319-22, 2191-92.

Although, in contrast to its approach toward glyphosate, EPA did conduct

new analyses of some risks posed by 2,4-D, it failed to consider harm to monarch

habitat. The new uses of Enlist Duo approved by EPA present an acute threat to

monarchs by increasing 2,4-D use and thereby reducing agricultural milkweed

habitat. EPA’s registration of Enlist Duo will increase 2,4-D use by as much as 600

percent. ER 83, 353. But the risk to monarchs comes not just from the steep rise in

use of an active ingredient that targets milkweed, but also from changes in how

that chemical can now be used. EPA’s registration of Enlist Duo allows 2,4-D to

be applied both at higher rates and later in the growing season, during milkweed’s

vulnerable flowering stage. See ER 28, 320-21, 547, 1765. Without evaluating

potential harm to monarchs’ milkweed habitat from Enlist Duo’s new uses of 2,4-

D, EPA lacked substantial evidence to conclude that Enlist Duo would not


45

“significantly increase the risk of any unreasonable adverse effect on the

environment.” 7 U.S.C. § 136a(c)(7)(B).

Although the question of risks to monarchs through increased milkweed

destruction was properly before the agency, EPA refused to consider it before

registering Enlist Duo. In its Response to Comments, EPA skirted the issue

through two oblique responses. First, EPA proffered its completion of a 2,4-D-

related “non-target direct effects risk assessment for terrestrial invertebrates,

specifically referencing monarch butterflies as a member of this taxa” and cited its

underlying 2016 Ecological Risk Assessment. ER 63-64; see ER 568. But the

“direct effects” that EPA studied included only acute oral and contact toxicity to

monarchs from direct 2,4-D exposure—and did not include any indirect effects that

the 2,4-D in Enlist Duo would have on monarchs through destruction of the

butterflies’ milkweed habitat. See ER 626-28, 66; see also ER 173 (commenting to

EPA that “it is not sufficient for EPA to examine whether 2,4-D is toxic to

monarchs or other invertebrates”).

Second, EPA asserted that it had “conducted a risk assessment for the

combined toxic effects to non-target plants . . . for glyphosate and 2,4-D

choline” and concluded “that effects to non-target plants . . . would be

limited to the treated field itself.” ER 63. But EPA was silent as to how

Enlist Duo’s effects on milkweed—a target plant that grows within treated


46

fields, see ER 112—would affect the monarch population. Notably, there is

evidence that monarchs have a pronounced preference for milkweed in

agricultural fields and lay more eggs there. ER 239, 273. Consequently,

further milkweed decline in agricultural fields across thirty-four states

squarely within the monarch migration pathway could have particularly

significant repercussions for the species’ survival. See ER 168, 266, 273.

Without considering how Enlist Duo’s novel uses of 2,4-D would impact

monarchs through their effects on milkweed, EPA lacked substantial evidence to

conclude that Enlist Duo “would not significantly increase the risk of any

unreasonable adverse effect on the environment,” as required for registration under

§ 136a(c)(7)(B). 7 U.S.C. § 136a(c)(7)(B); see Pollinator Stewardship Council,

806 F.3d at 532. Because EPA “entirely failed to consider an important aspect of

the problem,” its registration decisions were arbitrary, capricious, and not in

accordance with the law. State Farm, 463 U.S. at 43; accord Mont. Wilderness

Ass’n, 666 F.3d at 555, 558, 561. It follows that the decisions fail the substantial

evidence test under FIFRA, which is at least as rigorous as arbitrary-and-capricious

review. See Union Oil Co. of Cal., 542 F.2d at 1041.

The Court need not find that Enlist Duo increases risks to monarchs to

vacate the unlawful registration: that is a question for EPA. It is possible that had

EPA considered Enlist Duo’s harm to monarch habitat, it would have concluded


47

that the pesticide “would not significantly increase the risk of any unreasonable

adverse effect on the environment.” 7 U.S.C. § 136a(c)(7)(B). The agency’s legal

error was in refusing even to consider the matter before registering Enlist Duo. See

State Farm, 463 U.S. at 43; Mont. Wilderness Ass’n, 666 F.3d at 555, 558, 561.

Without having done so, EPA’s decisions lack substantial evidence and violate the

law.

B. EPA ignored evidence that registering Enlist Duo would result in increased glyphosate use over time and thereby amplify risks that glyphosate poses to both monarchs and humans

There is considerable evidence in the record suggesting that glyphosate use

would decrease but for EPA’s registration of Enlist Duo. As the agency observed,

“weed control experts warn that the problem of glyphosate resistance is increasing,

and that significant economic consequences will continue to increase without

effective alternatives for weed control.” ER 29-30. In other words, glyphosate is

losing efficacy, as confirmed by comments from growers and experts reporting

adoption of non-glyphosate-based alternatives. See, e.g., ER 459, 507.

Enlist Duo presents a pathway for reversing, or at least slowing,

glyphosate’s descent toward obsolescence: “the herbicide combination in this weed

control systems approach could potentially prolong the effectiveness of the

glyphosate technology if the two herbicides are controlling weeds that are not

resistant to either herbicide.” ER 28. As a result, Enlist Duo may perpetuate


48

glyphosate use at higher levels, for a longer time, in comparison to a landscape

without Enlist Duo.

Compared to that status quo, registration of Enlist Duo will thus likely

amplify glyphosate use and any risks inherent in that use. These include not only

risks to monarchs from destruction of milkweed, see supra Statement of the Case

II, but also risks to human health, as identified in recent scientific studies that EPA

declined to consider, see supra Statement of the Case III. EPA assumed, without

evidence, that registration of Enlist Duo will not “significantly change the

locations, methods, or volume of glyphosate used on corn, soybeans, or cotton.”

ER 4. But without any analysis to support this “expect[ation],” id., and without

considering the new evidence of glyphosate’s potential to harm monarchs and

human health, the agency lacked substantial evidence to conclude that Enlist Duo

“would not significantly increase the risk of any unreasonable adverse effect on the

environment.” 7 U.S.C. § 136a(c)(7)(B); see Nanosilver II, 857 F.3d at 1039-40

(holding as unsupported by substantial evidence EPA’s finding that registration of

a new nanosilver pesticide was in the public interest because it may reduce the

total amount of silver released to the environment, where the agency failed to

substantiate the assumptions underlying that finding).

As with 2,4-D’s potential to harm milkweed and monarchs, the Court need

not decide that the glyphosate in Enlist Duo actually increases risk of harm to


49

monarchs or human health. The agency erred by failing to evaluate evidence of

those risks before registering Enlist Duo, and this failure warrants vacatur.17 See

State Farm, 463 U.S. at 43, 56; Mont. Wilderness Ass’n, 666 F.3d at 555, 558, 561.

III. NRDC has standing to challenge EPA’s registration of Enlist Duo

To establish standing, NRDC must show that the interests it seeks to protect

are germane to its organizational purposes, that this litigation will not require its

members’ individual participation, and that its members would have standing to

sue in their own right. See Hunt v. Wash. State Apple Advert. Comm’n, 432 U.S.

333, 343 (1977).

NRDC satisfies this test. Protection of wildlife and human health is germane

to NRDC’s organizational mission, which is “to safeguard the Earth: its people, its

plants and animals, and the natural systems on which all life depends.” Trujillo

Decl. ¶¶ 6-8 (ADD 065-66). In addition, this lawsuit does not require the

17 To the extent that vacatur of the 2017 registration order would result in

reinstatement of the 2014 and 2015 registration orders, those earlier orders should also be vacated. The Supreme Court has “[made] clear that the touchstone of vacatur is equity,” Dilley v. Gunn, 64 F.3d 1365, 1370 (9th Cir. 1995), and it would be inequitable to allow EPA to reinstate the 2014 and 2015 orders following vacatur of the 2017 order. Those earlier orders are fully incorporated into the 2017 order, see ER 5 (“[T]he agency has made the decision to maintain the previously approved uses of Enlist DuoTM on GE corn and soybeans in 15 states with no changes to the original registration, as amended.”), and are unlawful for the same reasons. Furthermore, Petitioners timely challenged the earlier orders, but this Court dismissed Petitioners’ challenge after granting EPA’s voluntary motion for remand. See Order, NRDC v. EPA, No. 14-73353 (9th Cir. Jan. 25, 2016), ECF No. 128; Order, NRDC v. EPA, No. 14-73353 (9th Cir. Mar. 28, 2016), ECF No. 132.


50

participation of individual NRDC members, because NRDC does not seek any

individualized relief for its members. See Hunt, 432 U.S. at 344.

NRDC’s members would have standing to sue on their own because they

suffer “injury in fact” that is fairly traceable to the challenged EPA order and likely

to be redressed by a favorable decision. See Friends of the Earth, Inc. v. Laidlaw

Envtl. Servs. (TOC), Inc., 528 U.S. 167, 180-81 (2000) (citing Lujan v. Defs. of

Wildlife, 504 U.S. 555, 560-61 (1992)). NRDC members suffer at least two injuries

from the Enlist Duo registration: health risks from potential exposure to Enlist Duo

and diminished enjoyment of their natural environment resulting from loss of

monarch butterflies.

First, NRDC’s members include individuals who live in areas where Enlist

Duo is registered for use and who risk exposure to the pesticide during their daily

activities. Gruber Decl. ¶¶ 4-9 (ADD 059-61); Bristol ¶¶ 2-8 (ADD 051-53);

Wetzel Decl. ¶¶ 3-9 (ADD 069-72). Because both active ingredients in Enlist Duo

are linked to serious health harms, NRDC’s members are reasonably concerned

that exposure to Enlist Duo may harm them. See ER 148-51, 173-97, 202-05

(identifying potential health risks from exposure to glyphosate and 2,4-D); Gruber

Decl. ¶¶ 4-9 (ADD 059-61); Bristol ¶¶ 2-8 (ADD 051-53); Wetzel Decl. ¶¶ 3-9

(ADD 069-72). These members have no control over whether, when, how, and

where Enlist Duo will be applied to corn, soybean, and cotton crops grown in their


51

communities. Gruber Decl. ¶ 9 (ADD 060-61); Bristol ¶¶ 2-8 (ADD 051-53);

Wetzel Decl. ¶¶ 3-9 (ADD 069-72). This “credible threat of harm” to NRDC

members’ health interests “is sufficient to constitute actual injury for standing

purposes.” Cent. Delta Water Agency v. United States, 306 F.3d 938, 950 (9th Cir.

2002); see Nanosilver I, 735 F.3d at 878-79 (holding that NRDC had standing to

challenge EPA’s registration of a pesticide that “increase[d] the threat of future

harm to NRDC’s members”).

In addition, NRDC’s members include individuals who enjoy observing,

studying, and interacting with monarch butterflies in the states where EPA has

approved the use of Enlist Duo. Gruber Decl. ¶¶ 10-12 (ADD 061); Bristol ¶¶ 10-

14 (ADD 053-54); Wetzel Decl. ¶¶ 10-15 (ADD 072-74). These members’ “desire

to use or observe an animal species, even for purely esthetic purposes, is

undeniably a cognizable interest for purpose of standing.” Lujan, 504 U.S. at 562-

63. EPA’s registration of Enlist Duo is likely to exacerbate milkweed and monarch

decline. For these reasons, the registration harms these members’ interests in

monarch butterflies and impairs their enjoyment of the outdoors. Gruber Decl.

¶¶ 10-12 (ADD 061); Bristol ¶¶ 10-14 (ADD 053-54); Wetzel Decl. ¶¶ 10-15

(ADD 072-74).

The injuries to NRDC members’ health and enjoyment of monarch

butterflies are fairly traceable to EPA’s order registering Enlist Duo. EPA’s


52

registration order enables the sale and distribution of Enlist Duo, thereby allowing

Enlist Duo to be used in ways that may expose NRDC members to the herbicide

and making it possible for Enlist Duo to harm milkweed and monarchs.

Finally, the injuries to NRDC members are likely to be redressed, at least in

part, by an order vacating Enlist Duo’s registration. If the Court vacates the

registration, Enlist Duo will no longer be authorized for sale or distribution in the

United States. As a result, vacatur would prevent NRDC members from being

exposed to Enlist Duo, ameliorating their concerns and eliminating the health risks

from that exposure. Vacatur would also help to safeguard NRDC members’

interests in observing and interacting with monarch butterflies. Enlist Duo’s

registration is expected to increase 2,4-D use and bolster glyphosate use, which is

likely to harm milkweed. See supra Statement of the Case I; Argument II.B.

Vacating the registration would prevent this adverse effect, thereby benefiting

monarch butterflies and NRDC’s members. NRDC therefore has standing to

challenge EPA’s registration of Enlist Duo.

CONCLUSION

For the foregoing reasons, the Court should grant the petition for review and

vacate EPA’s registration of Enlist Duo. Vacatur should extend not only to EPA’s

2017 registration order, but also to the superseded 2014 and 2015 registration

orders if those orders would otherwise be reinstated.


53

Dated: April 11, 2018 Respectfully submitted, /s/ Margaret T. Hsieh Margaret T. Hsieh Mitchell S. Bernard Kaitlin Morrison Natural Resources Defense Council 40 West 20th Street New York, NY 10011 Telephone: (212) 727-2700 Facsimile: (415) 795-4799 [email protected] [email protected] [email protected] Peter J. DeMarco Natural Resources Defense Council 1152 15th Street NW Suite 300 Washington, DC 20005 Telephone: (202) 289-6868 Facsimile: (415) 795-4799 [email protected] Counsel for Petitioner NRDC


54

STATEMENT OF RELATED CASES

There are no known related cases pending in this Court.


55

CERTIFICATE OF COMPLIANCE

This brief complies with the type-volume limitation of Cir. R. 32-1(a)

because it contains 12,007 words, excluding the parts of the brief exempted by Cir.

R. 32-1(c) and Fed. R. App. P. 32(f).

This brief complies with the typeface requirements of Fed. R. App. P.

32(a)(5) and the type style requirements of Fed. R. App. P. 32(a)(6) because it has

been prepared in a proportionally spaced typeface using 14-point Times New

Roman font.

Dated: April 11, 2018 /s/ Margaret T. Hsieh

Counsel for Petitioner NRDC


56

CERTIFICATE OF SERVICE

I hereby certify that on April 11, 2018, I electronically filed the foregoing

brief and the accompanying declarations of Joan Bristol, LeRoy Gruber, Gina

Trujillo, and Diane Wetzel with the Clerk of the Court for the United States Court

of Appeals for the Ninth Circuit using the appellate CM/ECF system.

I certify that all participants in the case are registered CM/ECF users and

that service will be accomplished by the appellate CM/ECF system.

Dated: April 11, 2018 /s/ Margaret T. Hsieh

Counsel for Petitioner NRDC


ADDENDUM OF STATUTES AND REGULATIONS

Table of Contents

7 U.S.C. § 136 .................................................................................................. ADD 2

7 U.S.C. § 136a .............................................................................................. ADD 14

7 U.S.C. § 136n .............................................................................................. ADD 36

40 C.F.R. § 152.44 ......................................................................................... ADD 38

40 C.F.R. § 152.112 ....................................................................................... ADD 40

40 C.F.R. § 155.40 ......................................................................................... ADD 42

40 C.F.R. § 155.42 ......................................................................................... ADD 44

40 C.F.R. § 155.53 ......................................................................................... ADD 46

40 C.F.R. § 158.75 ......................................................................................... ADD 48

ADD 001


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ADD 047

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ADD 048

ADDENDUM OF DECLARATIONS IN SUPPORT OF STANDING

Table of Contents

Declaration of Joan Bristol ............................................................................ ADD 50

Declaration of LeRoy Gruber ......................................................................... ADD 57

Declaration of Gina Trujillo ........................................................................... ADD 64

Declaration of Diane Wetzel .......................................................................... ADD 68

ADD 049



NATIONAL FAMILY FARM COALITION, et al.,

Petitioners,



Respondent-Intervenor.

)))))))))))))))))

No. 17-70810

NATURAL RESOURCES DEFENSE COUNCIL, INC.,

Petitioner,

v. E. SCOTT PRUITT, et al.,



))))))))))))))))

No. 17-70817

DECLARATION OF JOAN BRISTOL

ADD 050


2

I, Joan Bristol, declare as follows:

1. I am currently a member of NRDC, and have been for about twenty

years. I appreciate and support NRDC’s work on human health and wildlife

protection.

2. I live about an hour west of Philadelphia in a rural area. I’m always

concerned about what farmers are putting into their crops because there are many

agricultural fields around where I live. We’re on an eight-acre farm surrounded by

other farms, and we also live right along a run which goes into the Brandywine and

Delaware Rivers. In addition, a lot of land around here has been put into

conservancy, but they can still be affected by pesticide use on nearby farms.

3. My neighbors’ fields are extremely close, less than a football field

away from my house. Fields that are directly adjacent to our property have always

been used for hay, but around here there are also soy, corn, and wheat fields. I have

noticed the farms nearby use a sprayer attached to a big tractor. I tried to find out

which pesticides they use but couldn’t get an answer.

4. I know that EPA has approved the use of the herbicide Enlist Duo for

use on corn, soybeans, and cotton in Pennsylvania, and I understand that Enlist

Duo contains glyphosate and 2,4-D, which have been linked to a number of human

health harms. I am concerned that Enlist Duo will be applied to the corn and

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soybean fields near my property, and especially concerned about cancer and other

health risks related to its use.

5. There are fields near our property that are also adjacent to our water

supply. We being rural are on our own well water, so even people just spraying

their lawns upstream can have an impact on our aquifer. I believe that pesticides

from adjacent fields—possibly including Enlist Duo—could get into our water

supply, and I don’t have a way of knowing how bad the impact is.

6. We ride horses in our neighbors’ fields three or four times a week for

an hour-and-a-half to two hours each time. We also walk twice a day, for about an

hour each day. I plan to continue living in my current home, and riding horses and

going for walks regularly.

7. I am concerned about being exposed to Enlist Duo since it can travel

through the air after being sprayed. If we’re walking around the neighboring farms

and a farmer has sprayed recently, I worry about inhaling the spray, and also worry

about my dog and other domestic pets in the area which might be impacted.

8. I also worry that residue on my own foods can contain Enlist Duo. I

purchase fresh corn from local farmers every week during the summer, and

although I try to verify with the famers that they do not use genetically modified

seeds or spray pesticides on their crops, I fear that the corn I purchase from them

may still contain traces of Enlist Duo that is applied to neighboring fields.

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Additionally, I fear that my horses could be eating hay contaminated with Enlist

Duo that has drifted through the air or hay grown in soil which has been exposed to

the pesticide.

9. I worked in the pharmaceutical industry for over thirty years, and

understand that if a new drug is going into the market that people are going to

ingest or swallow, it goes through rigorous testing. I believe a pesticide should

have to go through that process, too. A doctor must prescribe a drug, and if EPA is

“prescribing” Enlist Duo, it should make sure that the pesticide is actually safe for

people and the environment. I also think there should be a greater emphasis on

measuring and reining in the amount of contamination from chemicals like this.

10. I am also aware that Enlist Duo kills milkweed, the only source of

food for the monarch caterpillar, and that glyphosate and 2,4-D have been linked to

the decline of monarch populations.

11. As a kid I was always interested in the monarch butterfly, but at that

point they weren’t imperiled. Back then they were fairly common; I saw them all

the time and just considered them as part of nature. I remember going to camp and

easily catching butterflies. Now they’re much more rare, and when I see them it’s

such a treat.

12. Five or six years ago I learned about their plight, through

organizations like NRDC, World Wildlife Fund, and Friends of the Earth, as well

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as through films made by PBS, NRDC, World Wildlife Fund, and National

Geographic. There is a group called Natural Habitat Adventures which takes

people on tours down to Mexico to watch the Monarch migration. I have not yet

participated in the tour because spots fill up quickly and the timing has not worked

out so far, but given the opportunity I would do so.

13. Pennsylvania is in the path of the monarch migration, and I try to

observe monarchs whenever they’re here. Whenever I walk outside I try to keep an

eye out for monarchs. My husband and I have milkweed in the garden, and if they

have eggs out we try to observe without harming them. I hope to continue

watching the monarch migration in future years.

14. Monarchs are beautiful and wonderful insects, and the fact that

monarchs have decreased by ninety percent in twenty years is pathetic. We need to

do something about that.

15. My understanding of EPA’s role in regulating pesticides is that it is

required to make sure that they don’t pose unreasonable risks to people and the

environment. I think EPA should be taking a closer look at the effects of Enlist

Duo and scrutinizing the science on what’s really happening here. I think EPA

should put a hold on this chemical until it can prove it’s not unsafe, and in the

meantime nobody should be able to use it. I support NRDC’s lawsuit to revoke

EPA’s approval of Enlist Duo. If NRDC were to prevail, my health-related

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concerns regarding the risks posed by Enlist Duo would be resolved, and I would

be happy to know that monarch butterflies are protected from this threat.

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Petitioners,




) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) )

No. 17-70810


Petitioner,




) ) ) ) ) ) ) ) ) ) ) ) ) ) ) )

No. 17-70817

DECLARATION OF LEROY GRUBER

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I, LEROY GRUBER, do hereby affirm and state:

1. I am currently a member of the Natural Resources Defense Council

(NRDC) and have been for nearly fifteen years.

2. Among other reasons, I support the NRDC because I am concerned

about the impacts of chemicals, including pesticides, on human health and the

environment. Reading Rachel Carson’s Silent Spring was a major turning point in

my life, opening my eyes to the detrimental effects of indiscriminate pesticide use

on the natural world. Another critical moment in my life occurred when I read The

Limits to Growth, a report commissioned by the Club of Rome. Through this

report, I became convinced that mankind is releasing chemicals into the

environment much more quickly than we can neutralize the resulting harmful

effects; I firmly believe that we must take action to reverse this trend. I understand

that one of NRDC’s central purposes is to safeguard human health and the

environment from the toxic effects of pesticides and other chemicals, and I

strongly support this objective.

3. I worked in the environmental field for thirty-five years. As a

Supervising Engineer at the Hamilton County Department of Environmental

Services (DES) in Ohio, I became acutely aware of the human health risks, such as

cancers and neurodevelopmental harms, posed by exposure to chemicals in the

environment. I realized that exposures to even low concentrations of chemicals can

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pose serious health risks over time. I also realized that exposures to high

concentrations of chemicals, even if briefly, can result in significant health harms.

This awareness has heightened my concerns regarding exposure to pesticides,

including the herbicide Enlist Duo.

4. Since 2001, I have lived in rural Goshen, Ohio. My property is

situated near large agricultural fields planted with soybeans and corn. I am aware

that chemicals are sprayed on these fields, even though I do not know the exact

identity of those substances. I have seen machines spraying chemicals in the

morning, even when winds are blowing at higher speeds.

5. I am aware that EPA recently approved the herbicide Enlist Duo for

use on soybeans, corn, and cotton in Ohio. In addition, I am aware that Enlist Duo

contains 2,4-D and glyphosate, and that both chemicals are associated with various

human health risks. In particular, I understand that glyphosate is a probable human

carcinogen. I am concerned that Enlist Duo will be used on the fields next to my

property, and that I will be exposed to this herbicide and the health risks it poses,

including increased risk of developing cancer.

6. I am particularly concerned about exposure to Enlist Duo through

aerial pathways between my property and the adjacent fields. I am aware that

pesticides do not end up only on target crops. Rather, they invariably travel off site,

including through spray drift and volatilization. Among my other responsibilities at

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the Hamilton County DES, I used to model air pollutant emissions. Through this

experience, I became aware of the ease with which chemicals can be borne through

the air. I am thus especially worried about breathing in Enlist Duo through spray

drift and volatilization from the fields next to my home.

7. I had a three-quarter acre pond put on my property after moving in. I

stocked the pond with fish. We eat fish we catch from the pond. I am concerned

that pesticides and herbicides could settle out from the air into the pond or be

carried in by the stream that feeds into the pond. The fish could be contaminated.

We also grow vegetables to eat. Rain or fallout on our garden is another concern.

8. When I first moved to Goshen, I obtained drinking water from a

cistern on my property. Because I was concerned about pesticide spray drift

contaminating my cistern water, however, I spent about $5,000 installing a water

line that would allow me to obtain public drinking water from Clermont County.

Although I am now less concerned about herbicide exposure through my drinking

water, I remain very concerned that I may be exposed to harmful chemicals such as

glyphosate and 2,4-D through inhalation of airborne Enlist Duo from the

neighboring fields.

9. I avoid using herbicides on my own property, in part because I am

concerned about the health risks associated with exposure to these chemicals.

However, there is nothing I can do to prevent Enlist Duo from being used on the

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fields next to my property, where I intend to stay.

10. I understand that the monarch population has declined by nearly

ninety percent over the past twenty years, and that a main cause of this decline is

due to the destruction of milkweed, their only food source, by pesticides such as

glyphosate and 2,4-D.

11. I love to watch butterflies and even started a collection of photographs

of butterflies. When I was in college in downtown Cincinnati many years ago, I

used to watch countless monarchs fly by my window. I just don’t see as many now.

12. This year I planted milkweed on my property. It’s been a personal joy

of mine this year and every year to watch the monarch caterpillars, observe them

going through the chrysalis stage, release them and have them fly back to Mexico

in their final stage. Although there are fewer now, I plan to watch them as long as I

have eyes and monarchs continue to go through the area.

13. EPA has a duty to protect the public from the health risks and to

ensure the evaluation of environmental consequences posed by exposure to

herbicides. I am aware that NRDC has challenged EPA’s decision to approve Enlist

Duo in part because the agency failed to take into account adequately the health

and environmental risks the pesticide poses. I support NRDC’s lawsuit to revoke

EPA’s approval of Enlist Duo. If the court were to invalidate EPA’s approval of

Enlist Duo, and thereby prevent the herbicide from being used near my home, this

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would protect me from the health risks posed by glyphosate and 2,4-D. It would

also help protect the annual migration of monarchs through my area and the joy

that I attain from watching them.

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Petitioners,




)))))))))))))))))

No. 17-70810


Petitioner,




))))))))))))))))

No. 17-70817

DECLARATION OF GINA TRUJILLO

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I, GINA TRUJILLO, do hereby affirm and state:

1. I am the Director of Membership for the Natural Resources Defense

Council (NRDC). I have served in this position since January 2015.

2. My duties include supervising the preparation of materials that

NRDC distributes to members and prospective members. Those materials describe

NRDC and identify its mission.

3. NRDC is a membership organization incorporated under the laws of

the State of New York. It is recognized as a not-for-profit corporation under section

501(c)(3) of the United States Internal Revenue Code.

4. NRDC’s U.S. offices are located in New York, New York;

Washington, D.C.; Chicago, Illinois; Bozeman, Montana; San Francisco,

California; and Santa Monica, California.

5. NRDC currently has approximately 410,260 members in the United

States. There are NRDC members residing in each of the fifty United States and in

the District of Columbia.

6. NRDC’s mission statement declares that the organization’s purpose is

“to safeguard the Earth: its people, its plants and animals, and the natural systems

on which all life depends.” The mission statement goes on to declare that NRDC

strives “to protect nature in ways that advance the long-term welfare of present and

future generations,” and “to help create a new way of life for humankind, one that

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can be sustained indefinitely without fouling or depleting the resources that support

all life on Earth.” Accordingly, protecting human health by preventing pollution

ranks among NRDC’s top institutional priorities. As set forth in NRDC’s statement

of priorities: “Toxic chemicals in our environment . . . have been linked to cancer,

birth defects and brain impairments. Reducing or eliminating the load of these

dangerous chemicals in . . . the air we breathe, the food we eat and the water we

drink can help reduce the toll of human disease and suffering.”

7. Protecting monarch butterflies from the adverse effects of Enlist Duo

is paradigmatic of NRDC’s efforts to safeguard wildlife. NRDC has dedicated

significant resources to defending animal species against toxic chemicals,

including pesticides.

8. Protecting human health from the adverse effects of Enlist Duo

likewise exemplifies NRDC’s work. NRDC has sought for years to limit human

exposure to toxics.

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Petitioners,




)))))))))))))))))

No. 17-70810


Petitioner,




))))))))))))))))

No. 17-70817

DECLARATION OF DIANE WETZEL

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I, DIANE WETZEL, do hereby affirm and state:

1. I am currently a member of the Natural Resources Defense Council

(NRDC) and have been for approximately thirteen years.

2. My support for NRDC stems from my love of the outdoors and my

profound concerns about environmental degradation and its impacts on both

human beings and other creatures. Being a member of NRDC helps me give voice

to my environmental concerns. I support NRDC’s efforts to safeguard human

health and wildlife, including monarch butterflies, from the harms arising from

rampant pesticide use in America.

3. I have lived in West Lafayette, Indiana, for the past twenty years, and

plan to continue to live there for the foreseeable future. My home is located in a

heavily agricultural area, where corn and soybeans are the dominant crops. There

is a field directly behind my home, where corn and soybeans are planted in

alternating years. Half a mile down the road in the opposite direction, there is

another field planted with corn and soybeans. In addition, the entire area starting

from about two miles north of my home is devoted to agriculture, with corn and

soybean fields stretching as far as the eye can see.

4. I have seen pesticides being sprayed on the corn and soybean fields

near my home. Sometimes, vehicles with large, liquid-filled tanks, bearing

“flammable” warning labels, use mechanical arms to spray chemicals on the fields.

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I have also seen crop-dusting planes spraying pesticides on the fields two miles

from my home.

5. I am aware that EPA has approved the use of the herbicide Enlist Duo

for use on corn, soybeans, and cotton in Indiana. I understand that Enlist Duo

contains the chemicals 2,4-D and glyphosate. I am aware that 2,4-D has been

linked to thyroid disorders and other human health harms, and that glyphosate is

probably carcinogenic to humans, according to recent findings. I am concerned that

Enlist Duo will be applied to the corn and soybean fields near my property, and

that my health will be detrimentally affected by both inhalation of 2,4-D or

glyphosate and consumption of drinking water contaminated with 2,4-D or

glyphosate.

6. I am worried about direct exposure to Enlist Duo through

volatilization and spray drift. When the weather permits, I go running or biking

through the countryside three or four times a week. Doing so takes me past the

corn and soybean fields near my home. I have breathed in pesticides on some of

these excursions. While biking, for example, I have smelled heavy chemical odors

emanating from the fields. I am therefore concerned that I will inhale Enlist Duo

used in the fields around my property during my regular runs and bike rides.

7. I am also concerned about being exposed to Enlist Duo through my

drinking water. Although my drinking water comes from the West Lafayette

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municipal water system rather than local wells, testing has revealed high levels of

the pesticide atrazine in that system. This indicates to me that pesticides enter, and

are not fully removed from, the municipal water supply from which I obtain my

drinking water. Accordingly, I fear that Enlist Duo, like atrazine, will contaminate

the water that I drink.

8. I plan to continue living in my current home for at least the next five

years, and perhaps indefinitely. My husband is Director of Convocations at Purdue

University, and given the job market, it is unlikely that he will take a post

elsewhere in the near future. In addition, maintaining an active lifestyle is

important to me, so I plan to continue running and biking in the area around my

home three to four times a week. EPA’s approval of Enlist Duo for use in my area

thus threatens to expose me to 2,4-D and glyphosate, thereby putting my health at

risk.

9. In addition, I am concerned that my sixteen-year-old son—who

breathes the same air and drinks the same water as I do—will suffer health harms

through exposure to Enlist Duo. I understand that there has been an increase in

thyroid disorders among children in my area in recent years. One of my friend’s

doctors informed her, for example, that he has observed more and more cases of

thyroid conditions among local children. I am aware that 2,4-D has been

implicated in thyroid and developmental disorders. I am also aware that children

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are particularly vulnerable to the health risks posed by 2,4-D. I am therefore

especially concerned that my son will be harmed by inhalation of Enlist Duo

applied to the corn and soybean fields in my area, and by drinking municipal water

contaminated with 2,4-D.

10. My misgivings about EPA’s approval of Enlist Duo are grounded not

only in my concerns about my health and the health of my family, but also in my

concerns about the fate of the monarch butterfly migration. I am aware that

glyphosate and 2,4-D have contributed significantly to the decline of the monarch

butterfly. I have personally observed this decline in the area where I live.

11. I first became interested in monarch butterflies about ten years ago,

when my son was in kindergarten. As part of a school project, my son was given a

monarch cocoon. I bought my son books on monarchs and, upon reading about the

butterflies myself, became fascinated by these complex and lovely creatures. I have

since followed news on monarchs in newspapers and magazines, and on the

websites of organizations including NRDC.

12. I moved to West Lafayette in the summer of 1997. During my initial

years here, I saw approximately twenty monarchs every spring and summer. I saw

the butterflies while running or biking near my home and sometimes on my own

property. Seeing these marvelous insects filled me with delight. About fourteen

years ago, however, I began noticing a decline in the monarchs migrating through

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my area. Although the decline took place gradually, it has reached a point where I

see only one monarch—or no monarchs at all—each year.

13. When I first moved to West Lafayette, milkweed grew naturally along

the road at the edge of my property, but there was nothing growing on my lot. I

have since tried to attract monarchs to my property by planting a variety of

flowering, butterfly-attractive plants to complement the milkweed that grows on

nearby roads. For example, I have planted purple asters, sedum, black-eyed susans,

lavender, basil, and thyme. Despite these efforts, I see almost no monarchs now.

On the rare occasion that I do spot a monarch, I am filled with excitement.

However, the sighting also fills me with anxiety, as I fear that it will be my last.

Witnessing the monarch’s decline has filled me with great sadness, diminishing the

fulfillment I derive from observing these marvelous creatures. It has also lessened

my pleasure in gardening, insofar as the plants that I cultivate fail to attract and

benefit the butterflies.

14. I understand that glyphosate and 2,4-D both destroy milkweed, which

is the only food source for monarch caterpillars. I am also aware that glyphosate is

an ingredient in “Roundup Ready” pesticides. When I drive through the area

around my home, I see signs bearing the “Roundup Ready” logo along the corn

and soybean fields. I am concerned that EPA’s approval of Enlist Duo for use in

Indiana will increase the amount of glyphosate used in West Lafayette, further

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decimating the milkweed upon which monarchs depend. That Enlist Duo might

also increase the amount of 2,4-D used in my area troubles me further. I have been

dismayed by the significant decline in the number of monarchs migrating through

my area, a loss that has taken away from my enjoyment of living in the

countryside.

15. EPA should do more to protect both humans and monarchs from the

adverse effects of Enlist Duo. I am aware that NRDC has challenged EPA’s

decision to register Enlist Duo, based on harms to both human health and monarch

butterflies. I support NRDC’s lawsuit to nullify EPA’s approval of Enlist Duo. If

the court were to invalidate EPA’s approval of Enlist Duo, this would safeguard

the air I breathe and the water I drink from contamination by 2,4-D and glyphosate,

thereby protecting me from the health risks linked to exposure to these chemicals;

it would likewise protect my son from these same health risks. Revocation of

Enlist Duo’s registration would also limit further expansion in the use of 2,4-D and

glyphosate in West Lafayette, protecting the fragile migration of monarchs through

my area and the satisfaction I derive from observing the butterflies.

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