Opposition Brief — Monsanto Company, Petitioner v. John L. Durnell

Supreme Court briefJun 9, 2025

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No. 24-1068

IN THE

Supreme Court of the United States

__________

MONSANTO COMPANY,

Petitioner,

JOHN L. DURNELL,

Respondent.

__________

On Petition for a Writ of Certiorari

to the Missouri Court of Appeals

__________

BRIEF IN OPPOSITION FOR RESPONDENT

__________

JAMES G. ONDER

W. WYLIE BLAIR

GREGORY J. PALS

MARK E. BERNS

ONDERLAW, LLC

110 E. Lockwood Avenue

St. Louis, Missouri 63119

(314) 963-9000

T. ROE FRAZER II

THOMAS ROE FRAZER III

JAMES GRANT LABAR

FRAZER PLC

30 Burton Hills Boulevard

Suite 450

Nashville, Tennessee 37215

(615) 647-6464

June 9, 2025

DAVID C. FREDERICK

Counsel of Record

DEREK C. REINBOLD

KELLOGG, HANSEN, TODD,

FIGEL & FREDERICK,

P.L.L.C.

1615 M Street, N.W.

Suite 400

Washington, D.C. 20036

(202) 326-7900

(dfrederick@kellogghansen.com)

QUESTION PRESENTED

In Bates v. Dow AgroSciences LLC, 544 U.S. 431

(2005), this Court held that the Federal Insecticide,

Fungicide, and Rodenticide Act preempts only statelaw labeling requirements that are broader than

the statute’s misbranding standard. State-law claims

that target product marketing are not preempted

because they do not “require[ ] that manufacturers

label or package their products in any particular way.”

Id. at 444. And claims that target product labeling

are preempted only if they impose “requirements that

are ‘in addition to or different from’ the labeling and

packaging requirements under FIFRA.” Id. at 447

(quoting 7 U.S.C. § 136v(b)) (emphasis in Bates).

Respondent John L. Durnell developed non-Hodgkin

lymphoma after long exposure to petitioner Monsanto

Company’s weedkiller, Roundup. Durnell relied on

Monsanto’s off-label advertisements, which marketed

Roundup as safe to spray without the need for

personal protective equipment or other precautions.

And he relied on Roundup’s labeling, which contained

no warning that the International Agency for Research

on Cancer considers glyphosate, one of Roundup’s

ingredients, a probable human carcinogen. A jury

found that Roundup caused Durnell’s cancer and held

Monsanto liable for failing to warn of the product’s

danger in off-label marketing or in its label.

The question presented is:

Whether this Court should issue an advisory

opinion holding that the Missouri Court of Appeals

correctly applied Bates in holding that Durnell’s labelbased failure-to-warn claim was not preempted when

it was equivalent to FIFRA’s misbranding standard.

TABLE OF CONTENTS

Page

QUESTION PRESENTED .......................................... i

TABLE OF AUTHORITIES ...................................... iii

STATEMENT .............................................................. 3

A. Statutory And Regulatory Background .......... 3

B. Factual Background ......................................... 5

C. Procedural History ......................................... 14

REASONS FOR DENYING THE PETITION ......... 16

I. This Case Implicates No Circuit Conflict...... 16

A. Durnell’s Failure-To-Warn Verdict

Imposed No Labeling Requirements,

So Monsanto’s Preemption Arguments

Are Irrelevant ........................................... 17

B. The Third Circuit’s Decision In

Schaffner Created No Split Relevant

Here ........................................................... 20

II. The Decision Below Is Correct....................... 23

A. Durnell’s Failure-To-Warn Claim Is

Not Expressly Preempted ......................... 23

B. Monsanto’s Express-Preemption Arguments Lack Merit...................................... 24

C. Durnell’s Failure-To-Warn Claim Is

Not Impliedly Preempted ......................... 30

III. The Petition Meets No Other Traditional

Reason For Certiorari .................................... 33

CONCLUSION.......................................................... 35

APPENDIX ............................................................... 1a

iii

TABLE OF AUTHORITIES

CASES

Page

Anderson v. Monsanto Co., 2025 WL 1497539

(Mo. Ct. App. May 27, 2025) ............................... 35

Bates v. Dow AgroSciences LLC, 544 U.S. 431

(2005) ....................................................... 1, 3-5, 13,

17-21, 23-29, 31, 34

Brooke Grp. Ltd. v. Brown & Williamson

Tobacco Corp., 509 U.S. 209 (1993) ...................... 5

Caranci v. Monsanto Co., --- A.3d ---, 2025 WL

1340970 (Pa. Super. Ct. May 8, 2025) ................ 35

Hardeman v. Monsanto Co., 997 F.3d 941

(9th Cir. 2021)........................................ 7-8, 13, 17,

21-22, 26, 29, 35

Indian Brand Farms, Inc. v. Novartis Crop

Prot. Inc., 617 F.3d 207 (3d Cir. 2010)................ 27

Johnson v. Monsanto Co., 266 Cal. Rptr. 3d 111

(Ct. App. 2020) ..................................................... 35

Kiakombua v. Wolf, 498 F. Supp. 3d 1 (D.D.C.

2020)..................................................................... 24

MacDonald v. Monsanto Co., 27 F.3d 1021

(5th Cir. 1994)...................................................... 27

Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) ......24, 28

Merck Sharp & Dohme Corp. v. Albrecht,

587 U.S. 299 (2019) ............................................. 32

Monsanto Co. v. Hardeman, 142 S. Ct. 2834

(2022) ................................................................... 13

Monsanto Co. v. Pilliod, 142 S. Ct. 2870 (2022) ...... 13

Moore v. Ford Motor Co., 332 S.W.3d 749

(Mo. 2011) .................................................19, 23, 33

National Meat Ass’n v. Harris, 565 U.S. 452

(2012) ................................................................... 34

NRDC v. EPA, 38 F.4th 34 (9th Cir. 2022) ... 12-13, 24

Pilliod v. Monsanto Co., 282 Cal. Rptr. 3d 679

(Ct. App. 2021) .............................................. 6-7, 35

PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) ......... 28,

31-32

Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) .... 27-28

Schaffner v. Monsanto Corp., 113 F.4th 364

(3d Cir. 2024) ................................... 2, 16-17, 20-22

WorldCom, Inc. v. FCC, 246 F.3d 690 (D.C. Cir.

2001)..................................................................... 24

Wyeth v. Levine, 555 U.S. 555 (2009) .................. 30-32

STATUTES AND REGULATIONS

Federal Food, Drug, and Cosmetic Act,

21 U.S.C. § 301 et seq. ................................... 30-31

Federal Insecticide, Fungicide, and Rodenticide

Act, 7 U.S.C. §§ 136-136y ...................................... 1

§ 136(p)(2) ............................................................ 19

§ 136(q)(1)(A) ......................................................... 3

§ 136(q)(1)(F).................................................... 3, 28

§ 136(q)(1)(G) ........................................3, 23, 25, 28

§ 136a(a) ................................................................. 3

§ 136a(c)(2) ........................................................... 25

§ 136a(c)(5)(B)-(D) ........................................... 3, 25

§ 136a(f )(1) ........................................................... 32

§ 136a(f )(2) .................................................. 3, 25-28

§ 136a(g)(1)(A) ................................................. 3, 12

§ 136d(a)(2) ............................................................ 8

§ 136d(b) ................................................................. 3

§ 136j(a)(1)(E) ........................................................ 3

§ 136k(a)................................................................. 3

§ 136k(b)................................................................. 3

§ 136l ...................................................................... 3

§ 136v(a) ......................................................4, 17, 28

§ 136v(b) ................................................ 8, 16-18, 20

Federal Meat Inspection Act, 21 U.S.C. § 601

et seq. ................................................................... 33

Medical Device Amendments of 1976, Pub. L.

No. 94-295, 90 Stat. 539 ...................................... 28

40 C.F.R.:

§ 152.44 ................................................................ 22

§ 152.44(a) ............................................................ 22

§ 152.44(b) ............................................................ 22

§ 152.46(a) ............................................................ 21

§ 152.50(e) ............................................................ 32

§ 159.158(a) ............................................................ 8

ADMINISTRATIVE MATERIALS

California Off. of Env’t Health Hazard Assessment:

Glyphosate, https://perma.cc/E6VM-MCAF ....... 10

Initial Statement of Reasons: Glyphosate

Proposition 65 Safe Harbors (Mar. 28, 2017),

https://perma.cc/BL9Q-MPAY.......................... 9-10

Env’t Prot. Agency:

EPA Withdraws Glyphosate Interim Decision

(Sept. 23, 2022), https://perma.cc/EU77LMGN .................................................................. 25

Glyphosate: Proposed Interim Registration

Review Decision, No. 0178 (Apr. 2019),

https://perma.cc/P84R-A93H .......................... 10-11

Letter to Glyphosate Registrants (Aug. 7,

2019), https://perma.cc/6ZL4-JF8P ..................... 11

Off. of Pesticide Programs, Env’t Prot.

Agency, Revised Glyphosate Issue Paper:

Evaluation of Carcinogenic Potential (Dec.

12, 2017), https://perma.cc/2WJM-MT7R ........... 10

Fed. Jud. Ctr., Reference Manual on Scientific

Evidence (3d ed. 2011), https://perma.cc/V9UT98DR ...................................................................... 9

OTHER MATERIALS

Brief for the United States as Amicus Curiae,

Monsanto Co. v. Hardeman, No. 21-241

(U.S. May 10, 2022) ............................ 13, 17, 20-21,

23-27, 30, 32

vii

Class Action Settlement Agreement, In re

Roundup Prods. Liab. Litig., No. 3:16-md2741-VC, ECF #12509-2 (N.D. Cal. Feb. 3,

2021)....................................................................... 4

Jack Suntrup, Nine Missouri Republicans

declare Bayer legal shield ‘dead on arrival’

in Senate, St. Louis Post-Dispatch (Feb. 24,

2025), available at https://www.stltoday.com/

news/local/government-politics/article_

4131afb6-f2c0-11ef-ae59-dfe1b4dfa17d.html ..... 13

INTRODUCTION

Monsanto has known for decades that its popular

weedkiller, Roundup, can cause cancer. But the

company has refused to make its product safer or to

inform consumers that they should exercise caution

when using it. Instead, Monsanto has marketed

Roundup as safe to spray in a t-shirt and shorts.

Respondent John L. Durnell is one of Monsanto’s

victims. Unaware of the dangers, he used Roundup to

keep his St. Louis community free from weeds. From

the 1990s until his cancer diagnosis in 2018, Durnell

sprayed the weedkiller in parks near his home.

The result was a deadly and incurable form of nonHodgkin lymphoma, a blood cancer. The jury found

that Roundup caused that cancer and that Monsanto

was liable for Durnell’s damages.

Monsanto now argues—as it has argued with little

success for years—that it should be immune from

claims like Durnell’s, which it says are preempted by

the Federal Insecticide, Fungicide, and Rodenticide

Act, 7 U.S.C. §§ 136-136y, or FIFRA. As the Solicitor

General explained in a similar case, Monsanto is

incorrect.

This case meets none of the traditional criteria for

certiorari. To begin, this Court’s review of Monsanto’s

preemption argument would be purely advisory. In

Bates v. Dow AgroSciences LLC, 544 U.S. 431 (2005),

the leading case on FIFRA preemption, this Court

held it was “perfectly clear” that FIFRA does not

preempt claims that would not require manufacturers

to “label or package their products in any particular

way.” Id. at 444. That describes Durnell’s claim,

which covered off-label conduct like Monsanto’s failure to warn of Roundup’s dangers in advertisements

on which Durnell relied. Nothing in FIFRA prevented

those advertisements from warning consumers that

Roundup may be carcinogenic or that they should

wear protective gear when spraying it. This Court’s

review of the labeling issue would not affect this alternative basis for affirmance, which Monsanto ignores.

Even if this Court views the labeling issues as

central, there is no split in authority and the decision

below is correct. The only case Monsanto cites as

favorable is Schaffner v. Monsanto Corp., 113 F.4th 364

(3d Cir. 2024), where the Third Circuit “express[ed] no

opinion as to whether” the theory of liability Durnell

has advanced was preempted. Id. at 386 n.13. It is

not: FIFRA preempts only state-law labeling requirements broader than federal requirements. Missouri

failure-to-warn claims parallel FIFRA, so they are not

preempted. As the Solicitor General has explained,

FIFRA’s preemption provision is “narrow” and does

not cover claims like Durnell’s.

Finally, Monsanto’s implied-preemption argument

—that federal law prohibits the cancer warning that

Missouri law requires—lacks merit. Monsanto never

has proposed a cancer warning for formulated

Roundup, and the U.S. Environmental Protection

Agency never has rejected one. Instead, EPA has

confirmed that FIFRA permits Monsanto to warn that

the science shows Roundup is carcinogenic.

Missouri has a right to protect its citizens from the

detrimental health effects of dangerous pesticides.

And Monsanto has exposed unwitting Missourians

to deadly harm. The company has tried and failed to

get Missouri’s legislature to immunize it from liability

for this misconduct. This Court should reject the

company’s attempt to get that same relief by judicial

fiat.

STATEMENT

A. Statutory And Regulatory Background

1. FIFRA regulates “the use, as well as the sale

and labeling, of pesticides.” Bates 544 U.S. at 437. As

relevant here, the statute proscribes marketing “any

pesticide which is . . . misbranded.” § 136j(a)(1)(E).1 A

pesticide is “misbranded” if its label contains a statement that is “false or misleading,” § 136(q)(1)(A), or

omits adequate instructions for use, necessary warnings, or cautionary statements, § 136(q)(1)(F), (G).

If EPA determines a pesticide is misbranded, it

may cancel the pesticide’s registration, § 136d(b);

issue “stop sale, use, or removal” orders, § 136k(a); and

seize misbranded products, § 136k(b). Manufacturers

that sell misbranded products face civil and criminal

penalties. § 136l.

2. FIFRA requires pesticide manufacturers to

a pesticide if it determines—based on data the manufacturer submits—that (1) the product will not cause

unreasonable harm to humans and the environment

and (2) the product label is not “misbranded” under

FIFRA. § 136a(c)(5)(B)-(D). EPA re-reviews a pesticide’s registration, including its effects on human

health, every 15 years. § 136a(g)(1)(A).

FIFRA confirms that obtaining registration does

not relieve the registrant of liability if the pesticide is

misbranded. “In no event shall registration of an

article be construed as a defense for the commission

of any offense under [FIFRA].” § 136a(f )(2). Instead,

registration is merely “prima facie evidence that the

pesticide, its labeling and packaging comply with the

registration provisions.” Id. “Because it is unlawful

1 Except where noted, U.S. Code citations are to Title 7.

under the statute to sell a pesticide that is registered

but nevertheless misbranded, manufacturers have a

continuing obligation to adhere to FIFRA’s labeling

requirements.” Bates, 544 U.S. at 438.

Monsanto has updated Roundup’s labeling 44 times

since 1991 but never has sought permission from EPA

to warn of the product’s cancer risks. As part of a

proposed settlement of multidistrict litigation, the

company agreed to seek permission from EPA to

add on Roundup labels “links to relevant scientific

evidence and materials related to whether exposure to

Roundup Products causes [non-Hodgkin lymphoma]”

going forward. Class Action Settlement Agreement

at PDF p. 167, In re Roundup Prods. Liab. Litig.,

No. 3:16-md-2741-VC, ECF #12509-2 (N.D. Cal. Feb.

3, 2021). The MDL court rejected the settlement on

other grounds, and Monsanto never made that request

of EPA.

3. FIFRA “authorizes a relatively decentralized

scheme that preserves a broad role for state regulation.” Bates, 544 U.S. at 450. Indeed, States may ban

a federally registered pesticide, even if EPA does not

consider it misbranded. Id. at 446. Section 136v(a)

thus recognizes States’ historic authority to regulate

pesticides:

(a) In general

A State may regulate the sale or use of any

federally registered pesticide or device in the

State, but only if and to the extent the regulation

does not permit any sale or use prohibited by

[FIFRA].

§ 136v(a).

The only statutory limit on that traditional state

authority is a “narrow” preemption provision, Bates, 544

U.S. at 452, which “prohibits only state-law labeling

and packaging requirements that are ‘in addition to

or different from’ the labeling and packaging requirements under FIFRA,” id. at 447 (quoting § 136v(b))

(emphasis in Bates):

(b) Uniformity

Such State shall not impose or continue in effect

any requirements for labeling or packaging in

addition to or different from those required under

[FIFRA].

§ 136v(b).

Companies like Monsanto routinely obtain approval

for state- and locality-specific warnings on the labels

of their products. For example, Roundup Power Max’s

label discusses “requirements specific to your State

or Tribe,” App.30a,2 and includes such state-specific

requirements as restrictions on aerial spraying in

California and Arkansas, App.35a-40a, or different

application rates for sugarcane in Florida, Hawaii,

Louisiana, and Texas, App.42a-43a.

B. Factual Background

Roundup is a weedkiller developed by Monsanto. It

contains the active ingredient glyphosate, which kills

plants at their roots. Court of Appeals Respondent’s

Appendix (“RA”) 4 (¶ 12); 3 Tr. 1663:23-25.3 What

follows is the evidence relevant to preemption introduced at Durnell’s trial, where the jury found Monsanto liable for failing to warn of Roundup’s cancer

risks. This Court “view[s] the evidence in the light

most favorable” to the jury’s verdict. Brooke Grp. Ltd.

v. Brown & Williamson Tobacco Corp., 509 U.S. 209,

213 (1993).

2 Citations to “App.__a” are to the Appendix accompanying this

brief, which reproduces certain trial exhibits.

3 Citations to “Tr.” are to the Transcript on Appeal in

No. ED112410 (Mo. Ct. App. June 13, 2024).

1. Monsanto long has marketed Roundup as a

general-purpose weedkiller. RA4 (¶ 13), RA45 (¶ 38).

Roundup’s labeling does not tell consumers to wear a

mask, gloves, or other personal protective equipment

when spraying the weedkiller. 4 Tr. 2509:9-21. And

Monsanto has marketed Roundup as safe to use

without such precautions, including in television

advertisements with a man using Roundup “sort of

like a sharp shooter” shooting “weeds in his driveway”

while dressed in a “[s]hort-sleeve shirt, no gloves.”

4 Tr. 2515:11-2516:11.

The company offers stronger warnings to more

sophisticated users. Farmers, who typically buy

Roundup in concentrated form, are warned to wear

gloves when spraying the product and to wash their

clothes afterward. 3 Tr. 2344:10-2347:21; App.30a.

2. Monsanto has had EPA’s approval to sell

glyphosate-based weedkillers since the mid-1970s.

RA4 (¶ 12), RA8 (¶ 16). To obtain that approval,

Monsanto submitted studies conducted by Industrial

Bio-Test Laboratories, or IBT. RA39 (¶ 9).

IBT’s studies were fraudulent, as the Food and Drug

Administration (not EPA) later uncovered. RA68;

2 Tr. 1020:8-1022:24; see Pilliod v. Monsanto Co., 282

Cal. Rptr. 3d 679, 710 (Ct. App. 2021) (“fraudulent

data” from IBT). Three IBT executives were convicted

of criminal fraud in 1983. RA39 (¶ 11). Dr. Paul Wright,

a longtime Monsanto employee, was one of them. Id.;

2 Tr. 1021:14-16.

IBT’s fraud surfaced in 1976. RA68. Yet Monsanto

did not inform consumers about the fraud, remove

Roundup from the market, or add warnings. See

Pilliod, 282 Cal. Rptr. 3d at 712. A 1983 EPA report

explained that, after IBT’s fraud was exposed, some

experts advocated “that all 212 pesticides tested in

whole or in part by IBT be removed from the market

pending retesting.” RA63. But “that option [wa]s not

available under [then-]current law.” Id.

Nearly a decade passed before a valid study

assessed glyphosate. RA40 (¶ 13). In 1985, EPA

reviewed studies showing that glyphosate could cause

cancer in laboratory animals. Id. (¶ 15); App.18a.

Based on that review, EPA classified glyphosate as a

possible human carcinogen. RA40 (¶ 15); see Hardeman v. Monsanto Co., 997 F.3d 941, 951 (9th Cir.

2021).

3. In the late 1990s, four studies concluded that

glyphosate was possibly genotoxic. RA41 (¶ 22);

see RA73. Genotoxic substances damage genetic

information in cells, causing mutations that may lead

to cancer. See Pilliod, 282 Cal. Rptr. 3d at 689 n.2.

Monsanto hired Dr. James Parry to review the studies.

App.1a; 3 Tr. 1702:21-1703:4. Dr. Parry concluded

that glyphosate could be genotoxic and suggested a

battery of tests that Monsanto could conduct to learn

more. App.1a-8a.

After reading one of Dr. Parry’s reports, Monsanto’s

Dr. William Heydens candidly wrote to colleagues:

[L]et’s step back and look at what we are really

trying to achieve here. We want to find/develop

someone who is comfortable with the genetox

profile of glyphosate/Roundup and who can be

influential with regulators and Scientific Outreach

operations when genetox[ ] issues arise. My read

is that Parry is not currently such a person, and

it would take quite some time and $$$/studies to

get him there. . . . Mark, do you think Parry can

become a strong advocate without doing this work

. . . ? If not, we should seriously start looking for

one or more other individuals to work with. Even

if we think we can eventually bring Parry around

closer to where we need him, we should be

currently looking for a second/back-up genetox[ ]

supporter.

App.9a-10a. Dr. Heydens decreed that “We simply

aren’t going to do the studies Parry suggests.” Id.

And Monsanto never did conduct any of Dr. Parry’s

suggested tests. RA43 (¶ 28). Nor did Monsanto

share Dr. Parry’s report or suggestions with EPA.

RA44 (¶ 30).4

Monsanto instead retained Dr. Gary Williams, a

pathologist. RA45 (¶ 39). Dr. Williams published an

article in 2000 concluding that Roundup does not pose

a health risk to humans. Id. But Dr. Williams did not

write that article; Monsanto’s Dr. Heydens ghostwrote

it. RA46 (¶ 40). EPA later relied on the Williams

article when evaluating glyphosate’s carcinogenic

potential. Id. (¶ 42).

In sum, “after its own hired expert, Dr. Parry, found

that glyphosate—alone and when mixed with other

chemicals in Roundup—had increased genotoxic risks,

evidence was sufficient to infer that Monsanto largely

failed to perform further studies. Instead, Monsanto

helped author an article downplaying glyphosate’s

health and safety concerns.” Hardeman, 997 F.3d at

971.

4. Monsanto has resisted testing formulated

Roundup. Glyphosate is not the only ingredient in the

weedkiller; it also contains a surfactant. In the United

States, the surfactant is polyethoxylated tallow amine,

4 Monsanto’s failure to share Dr. Parry’s report with EPA

violated FIFRA, which requires manufacturers to report “factual

information regarding unreasonable adverse effects on the

environment of [a] pesticide” to EPA on an ongoing basis,

§ 136d(a)(2); see 40 C.F.R. § 159.158(a).

or POEA. RA44 (¶ 33). Surfactants decrease surface

tension, so POEA enables Roundup to penetrate the

waxy surface of a leaf—or human skin. 3 Tr. 1664:36, 1665:4-8, 2008:12-16.

POEA makes Roundup more genotoxic. RA44 (¶ 34).

POEA is banned in Europe, where Monsanto now sells

Roundup with a less toxic surfactant. Monsanto’s

Dr. Heydens wrote in 2015 that he believed “the

surfactant in the formulation . . . played a role” in a

tumor promotion study. RA80; see RA45 (¶ 36).

Roundup contains other carcinogenic ingredients,

too. App.20a-22a. As one of Durnell’s experts

testified, formulated Roundup contains “[s]everal”

cancer-causing contaminants and impurities, including “Ethylene oxide and 1,4-Dioxane.” 3 Tr. 2007:222008-2.

Monsanto never has tested whether Roundup as

formulated causes cancer. App.45a. In a 2009 email,

Dr. Farmer wrote that the company “cannot say that

Roundup does not cause cancer . . . we have not done

carcinogenicity studies with ‘Roundup.’ ” App.11a

(ellipsis in original).

5. In 2015, a working group at the International

Agency for Research on Cancer, or IARC, concluded

that glyphosate is probably carcinogenic to humans.

RA48 (¶ 50). IARC is one “of the most well-respected

and prestigious scientific bodies,” whose assessments

of the carcinogenicity of chemicals “are generally

recognized as authoritative.” Fed. Jud. Ctr., Reference

Manual on Scientific Evidence 20, 564 n.46 (3d ed.

2011), https://perma.cc/V9UT-98DR. Soon after, other

countries banned Roundup.

In 2017, based on IARC’s finding, California categorized glyphosate as a chemical known to the State

to cause cancer. See California Off. of Env’t Health

Hazard Assessment, Initial Statement of Reasons:

Glyphosate Proposition 65 Safe Harbors (Mar. 28,

2017), https://perma.cc/BL9Q-MPAY. California requires

a warning label on glyphosate products. See OEHHA,

Glyphosate, https://perma.cc/E6VM-MCAF.

6. EPA has made no formal findings about

whether formulated Roundup causes cancer. In 2017,

the agency determined that it could not reach “a conclusion regarding the association between glyphosate

exposure and risk of [non-Hodgkin lymphoma].”5

EPA explained that the data were uncertain,

partly because “farmers and other applicators apply

formulations, not the active ingredient alone.”6 Agency

advisors had “conflicting views on how to interpret

the overall results for [non-Hodgkin lymphoma].”7

And EPA acknowledged the need for more research

“to determine whether formulation components, such

as surfactants, influence the toxicity of glyphosate

formulations.”8

In April 2019, EPA noted that “[m]any commenters

expressed concerns that glyphosate formulations are

more toxic than glyphosate alone and questioned the

toxicity of inert ingredients and the lack of transparency for inert ingredients and other contaminants in

pesticide products.”9 In response, EPA acknowledged

5 Off. of Pesticide Programs, EPA, Revised Glyphosate Issue

Paper: Evaluation of Carcinogenic Potential 68 (Dec. 12, 2017),

https://perma.cc/2WJM-MT7R.

6 Id. at 137 (emphasis added).

7 Id. at 67.

8 Id. at 144.

9 EPA, Glyphosate: Proposed Interim Registration Review

Decision, No. 0178, at 10 (Apr. 2019), https://perma.cc/P84RA93H.

that “few research projects” had tried to compare

“technical grade glyphosate” to glyphosate-based

formulations like Roundup.10 EPA said if, “at any

time, information becomes available that indicates

adverse human health effects of concern for exposure

to glyphosate or its formulations, the EPA intends to

review it and determine the appropriate regulatory

action.”11

In August 2019, the Director of the Registration

Division within EPA’s Office of Pesticide Programs

issued a letter to all glyphosate-based product registrants. Letter from EPA to Glyphosate Registrants

(Aug. 7, 2019), https://perma.cc/6ZL4-JF8P (“August

2019 Letter”). The letter stated EPA would no longer

approve labeling that warned consumers glyphosate

was a chemical known to California to cause cancer,

and that manufacturers must remove such a glyphosatebased cancer warning. Id. This letter was not the

product of notice-and-comment rulemaking and took

no position on whether Roundup causes cancer.

In April 2022, a higher-ranking EPA official, the

Assistant Administrator for the Office of Chemical

Safety and Pollution Prevention, wrote that “EPA

could approve” California’s newly proposed glyphosatespecific warning:

CALIFORNIA PROPOSITION 65 WARNING:

Using this product can expose you to glyphosate.

[IARC] classified glyphosate as probably carcinogenic to humans. US EPA has determined that

glyphosate is not likely to be carcinogenic to

humans; other authorities have made similar

determinations. A wide variety of factors affect

10 Id. at 11.

11 Id.

your potential risk, including the level and duration of exposure to the chemical. For more information, including ways to reduce your exposure,

go to www.P65Warnings.ca.gov/glyphosate.

RA57 (“April 2022 Letter”). The Assistant Administrator added that EPA “could” approve the warning

“if pesticide registrants” like Monsanto “requested

it for inclusion on glyphosate product labels.” RA58.

Because the warning “would not be considered false

and misleading,” products bearing it “would not be

considered misbranded.” Id.

7. EPA’s conclusion that glyphosate is not likely

to cause cancer has been vacated. FIFRA requires

that “registrations of pesticides are to be periodically

reviewed” by EPA every 15 years. § 136a(g)(1)(A). In

2009, EPA started its re-registration review of glyphosate. EPA “decided to conduct registration review

on glyphosate, an active ingredient,” rather than to

“evaluate each pesticide product registration [such as

Roundup] individually.” NRDC v. EPA, 38 F.4th 34,

41 n.2 (9th Cir. 2022).

EPA’s re-registration proceeding lasted 11 years. In

January 2020, the agency “determined that there are

no risks to human health from the current registered

uses of glyphosate and that glyphosate is not likely to

be carcinogenic to humans.” Id. at 43.

The Ninth Circuit vacated the agency’s “not likely to

be carcinogenic” conclusion, calling EPA’s reasoning

“the hallmark of arbitrary action.” Id. at 51. The

“not likely” determination was “in tension with parts

of the agency’s own analysis and with the guidelines

it purports to follow,” and thus not supported by

“substantial evidence.” Id. at 46, 51. For example,

“most studies EPA examined indicated that human

exposure to glyphosate is associated with an at least

somewhat increased risk of developing [non-Hodgkin

lymphoma].” Id. at 46.

8. The United States has taken the position that

EPA registration decisions do not preempt state-law

claims. In May 2021, the Ninth Circuit in Hardeman

affirmed a jury verdict that Roundup caused Edwin

Hardeman’s cancer. The court rejected Monsanto’s

preemption claim because “EPA actions that Monsanto

alleges preempt Hardeman’s claims”—registration of

Roundup and the August 2019 Letter—“do not carry

the force of law.” Hardeman, 997 F.3d at 956.

Monsanto sought certiorari, and this Court called

for the views of the Solicitor General. The United

States opposed certiorari, explaining that Hardeman

was correctly decided.

See U.S. Amicus Brief,

Monsanto Co. v. Hardeman, No. 21-241 (U.S. May

10, 2022) (“SG Hardeman Br.”). The United States

said, “EPA’s approval of pesticide labeling without a

chronic-risk warning is not naturally characterized as

a FIFRA ‘requirement’ that no such warning appear,”

noting that a “ ‘requirement is a rule of law that must

be obeyed.’ ” Id. at 11-12 (quoting Bates, 544 U.S. at

445). The Court denied certiorari. Monsanto Co. v.

Hardeman, 142 S. Ct. 2834 (2022); see also Monsanto

Co. v. Pilliod, 142 S. Ct. 2870 (2022) (same).

9. For two years, Monsanto has been seeking a

legislative fix in Missouri. It tried and failed to get

a bill passed in 2024 granting it immunity from

Missouri failure-to-warn liability. And it tried and

failed to get similar legislation passed this year. See

Jack Suntrup, Nine Missouri Republicans declare

Bayer legal shield ‘dead on arrival’ in Senate, St. Louis

Post-Dispatch (Feb. 24, 2025), available at https://www.

stltoday.com/news/local/government-politics/article_

4131afb6-f2c0-11ef-ae59-dfe1b4dfa17d.html.

C. Procedural History

1. Respondent John L. Durnell started using

Roundup in 1996. 4 Tr. 2584:18-22. For more than

two decades, Durnell sprayed the weedkiller at the

parks around the historic Soulard neighborhood of

St. Louis—he “was the spray guy” for a neighborhood

association. 4 Tr. 2461:4-10, 2463:9-12, 2520:13-15.

Spraying Roundup would take Durnell hours each

week during the growing months. 4 Tr. 2537:10-23.

He did not wear protective equipment—gloves, a face

mask, or goggles—when spraying. 4 Tr. 2518:14-19.

Durnell thought safety precautions were unnecessary. Based on Roundup’s marketing and labeling,

he thought the weedkiller “was a safe product to use.”

4 Tr. 2485:17-21. He trusted Monsanto to sell safe

products—or at least to warn about any dangers or

risks associated with its products. 4 Tr. 2514:12-22.

Monsanto never included such a safety warning on

its Roundup bottles or in its advertisements. 4 Tr.

2514:23-25, 2515:21-2516:4. Instead, the company

marketed the weedkiller with Western-themed advertisements featuring a homeowner wearing short

sleeves and “using the small Windex-size bottle of

Roundup sort of like a sharp shooter.” 4 Tr. 2515:1520, 2516:7-11.

Durnell would not have bought

Roundup if Monsanto had disclosed that the weedkiller could cause cancer. 4 Tr. 2515:7-10, 2517:8-10.

Durnell was diagnosed with mantle cell lymphoma

in 2018. Mantle cell lymphoma is both fatal and

incurable—in other words, if Durnell does not die of

other means, he will die of this cancer. 4 Tr. 2671:2324, 2681:8-12. Durnell’s first thought after receiving

his diagnosis was “who’s going to take care of

Richard,” his husband and partner of five decades.

4 Tr. 2564:3-8.

Durnell is in remission. 4 Tr. 2569:19; see App.49a.

But multiple rounds of chemotherapy have left a

lasting mark: Durnell lost 15 pounds, 4 Tr. 2567:14,

endured excruciating pain, and has continuing issues

with his legs, 4 Tr. 2568:10-12, 2568:19-2569:25.

He is no longer able to work to beautify his neighborhood—in his words, “I’m not that physical any longer.”

4 Tr. 2573:1-5.

2. Durnell sued Monsanto in January 2019. RA2

(¶ 1). He brought design-defect and failure-to-warn

claims in strict liability and negligence.

At summary judgment, the trial court rejected Monsanto’s express- and implied-preemption arguments.

Court of Appeals Appellant’s Appendix (“AA”) 4. The

court likewise found a triable issue of fact on Durnell’s

claim for punitive damages. Id.

At trial, Durnell presented expert testimony proving

that Roundup causes non-Hodgkin lymphoma and

that his own exposure to Roundup was a direct cause

of his cancer. And the jury heard testimony about

Monsanto’s reprehensible conduct.

The jury awarded $1.25 million to Durnell in

compensatory damages on his failure-to-warn claim.

AA10. The jury found for Monsanto on Durnell’s

claims for design defect, negligence, and punitive

damages. Id.

Monsanto moved for judgment notwithstanding the

verdict. The trial court denied the motion. AA9.

3. Monsanto appealed on preemption grounds.

App.4. The Missouri Court of Appeals, Eastern

District, affirmed. App.2. The appellate court found

Durnell’s claim not preempted because “a strict liability failure to warn claim in Missouri does not impose

a requirement ‘in addition to or different from’ the

requirements of FIFRA.” App.7.

Monsanto sought further review from the Supreme

Court of Missouri, which denied the application. App.1.

REASONS FOR DENYING THE PETITION

Monsanto’s petition does not challenge Durnell’s

off-label failure-to-warn claim. FIFRA does not reach

that claim, which presents an alternative basis to

affirm the Missouri Court of Appeals. That court also

rightly decided that Durnell’s label-based failure-towarn claim against Monsanto was neither expressly

nor impliedly preempted. There is no split on that

issue, and no other criterion for certiorari is met. The

petition therefore should be denied.

I. This Case Implicates No Circuit Conflict

Monsanto’s purported circuit split is (1) irrelevant

and (2) illusory. It is irrelevant because the jury’s

verdict here did not turn exclusively on Roundup’s

labeling. The evidence at trial showed that Monsanto

had marketed Roundup as safe in television advertisements that failed to warn Durnell that the weedkiller

can cause cancer. Those advertisements are beyond

FIFRA’s reach; § 136v(b) addresses only pesticide

labeling, not TV ads. So no federal requirement

stopped Monsanto from warning Durnell about

Roundup’s cancer risks in advertising or elsewhere.

Monsanto ignores this issue, but it provides an

independent basis to deny review.

But even as to Monsanto’s failure to warn of

Roundup’s risks in its labeling, there is no real split.

In the company’s lead case, the Third Circuit

“express[ed] no opinion” on the core preemption

question here: whether “FIFRA required Monsanto”

to seek “EPA approval for a modified Roundup label

that included” a cancer warning, thus imposing a

federal duty that parallels Missouri law. Schaffner,

113 F.4th at 386 n.13. Monsanto’s claimed split is an

illusion, not a basis for certiorari.

A. Durnell’s Failure-To-Warn Verdict Imposed

No Labeling Requirements, So Monsanto’s

Preemption Arguments Are Irrelevant

When the government opposed certiorari in Hardeman, it noted that “[f ]uture cases involving similar

state-law claims may contemplate warnings through

non-labeling mechanisms that would not require

altering EPA-approved labeling.” SG Hardeman

Br. 20. This is such a case, which makes it unsuitable

for further review: no appellate court has assessed

whether a failure-to-warn claim involving Monsanto’s

marketing of Roundup is preempted under FIFRA.

“[U]nless and until a conflict in authority emerges” on

that issue, “[t]here is no sound reason for the Court to

grant review.” Id. at 19.

1. FIFRA “authorizes a relatively decentralized

scheme that preserves a broad role for state regulation.” Bates, 544 U.S. at 450. Indeed, States may ban

a federally registered pesticide, even if EPA does not

consider it misbranded. Id. at 446 (citing § 136v(a)).

State tort claims supplement federal pesticide

regulation. Although FIFRA itself “does not provide a

federal remedy to [those] who are injured as a result

of a manufacturer’s violation of FIFRA’s labeling

requirements, nothing in § 136v(b) precludes States

from providing such a remedy.” Id. at 448. There is a

“long history of tort litigation against manufacturers

of poisonous substances.” Id. at 449-51. This Court

thus observed that “[p]rivate remedies that enforce

federal misbranding requirements would seem to aid,

rather than hinder,” FIFRA’s functioning. Id. at 451.

The only statutory limit on state authority is a

“narrow” preemption provision, id. at 452, which

“prohibits only state-law labeling and packaging

requirements that are ‘in addition to or different

from’ the labeling and packaging requirements under

FIFRA,” id. at 447 (quoting § 136v(b)) (emphasis in

Bates). This provision “calls for an examination of the

elements of the common-law duty at issue.” Id. at 445.

For a state tort claim to be preempted, it must set

forth (1) “a requirement ‘for labeling or packaging’ ”

(2) “that is ‘in addition to or different from’ ” one of

FIFRA’s requirements. Id. at 443-44 (quoting § 136v(b))

(emphases in Bates).

The preemption inquiry thus proceeds in two steps:

Courts first ask whether a state-law claim imposes

any requirement for pesticide labeling or packaging.

Claims that would not require manufacturers to “label

or package their products in any particular way” are

not preempted. Id. at 444; see id. (“petitioners’ claims

for defective design . . . are not pre-empted”). For

example, Bates found it “perfectly clear” that commonlaw claims “that require manufacturers to design

reasonably safe products” and “use due care in

conducting appropriate testing of their products” are

not preempted. Id.

Next, courts ask whether the state-law labeling

requirement is “in addition to or different from those

required under [FIFRA].” § 136v(b). Common-law

duties are not preempted if they are “equivalent to,

and fully consistent with, FIFRA’s misbranding

provisions.” Bates, 544 U.S. at 447; see id. at 454 (“[A]

manufacturer should not be held liable under a state

labeling requirement subject to § 136v(b) unless the

manufacturer is also liable for misbranding as defined

by FIFRA.”). In other words, FIFRA does not preempt

state-law claims that impose “parallel requirements”

to those in FIFRA. Id. at 447.

2. Monsanto’s argument fails at the first step,

as Durnell’s failure-to-warn claim imposed no labeling

or packaging requirements. Monsanto ignores this

issue, but it provides an independent basis to affirm

the judgment and to deny the petition.

Durnell’s failure-to-warn claim was not limited to

Roundup’s labeling. Under Missouri law, he just

had to show that Monsanto failed to “give adequate

warning of the danger.” Moore v. Ford Motor Co.,

332 S.W.3d 749, 756 (Mo. 2011) (en banc); see 5 Tr.

3378:21-22 (instructing jury to consider whether

Monsanto failed to “give an adequate warning of the

danger” from Roundup). The jury thus heard evidence

about the marketing and promotion of Roundup,

where Monsanto failed to warn consumers like

Durnell about the product’s cancer risks. For example, Durnell described an advertisement depicting

Roundup as a product that ordinary consumers safely

could spray without needing any particular precautions or protective gear. And the jury heard evidence

that Durnell saw an advertisement, relied on it, and

sprayed the weedkiller around his neighborhood for

two decades, all while thinking it was safe. The jury

then concluded that “Roundup being sold without

an adequate warning”—whether in advertising or

elsewhere—“directly [caused] or directly contributed

to cause damage to plaintiff John Durnell.” 5 Tr.

3378:24-3379:2.

Durnell’s failure-to-warn claim thus imposed no

requirements for labeling or packaging. First, television

advertising is not “labeling,” which FIFRA defines as

“all labels and all other written, printed, or graphic

matter” that accompany a pesticide. § 136(p)(2). Like

“a sales agent’s oral representations,” Bates, 544 U.S.

at 444 n.17, a video advertisement does not meet this

definition.

Second, Durnell’s failure-to-warn claim did not

require Monsanto to “label or package their products

in any particular way.” Id. at 444; cf. SG Hardeman

Br. 20 (“It is far from clear . . . that California common

law actually requires an on-label warning.”). The

company could have avoided liability by adding a

warning to its television commercials, but chose not

to.

Monsanto also could have avoided failure-to-warn

liability by providing adequate warnings on Roundup’s

labeling. But that does not transform Durnell’s claim

into a labeling or packaging requirement subject to

§ 136v(b). Under Bates, “[a] requirement is a rule of

law that must be obeyed.” 544 U.S. at 445 (emphasis

added). Monsanto did not have to obey any labeling

or packaging rule—it could have kept Roundup’s

labeling and packaging the same yet avoided liability

by adding a warning to its advertisements.

B. The Third Circuit’s Decision In Schaffner

Created No Split Relevant Here

Even as to Roundup’s labeling, this case implicates

no circuit conflict. The central feature of Monsanto’s

petition is an illusory split the company says was

opened by Schaffner.12 But that narrow decision

provides no support for Monsanto’s petition.

1. In Schaffner, the Third Circuit found that the

plaintiff ’s Pennsylvania-law claim against Monsanto

was preempted. The court explained that a pesticide

manufacturer generally has two options to update

its product labeling: (1) “ ‘by notification,’ a procedure

under which the registrant must inform the EPA of

12 Counsel for Durnell represented Schaffner in petitioning for

en banc review in the Third Circuit, which evidently disagreed

that the panel had created a conflict warranting further review.

the modification but need not receive approval before

selling or distributing the modified pesticide”; or (2) by

applying for amended registration, which requires

EPA approval. 113 F.4th at 382. Schaffner addressed

only the first option, finding it unavailable. Id. at 385.

Schaffner did not address the second option because

of a unique quirk of that case: The plaintiff there had

not argued that “FIFRA required Monsanto” to seek

“EPA approval for a modified Roundup label that

included” a cancer warning.” Id. at 386 n.13. So the

court “express[ed] no opinion as to whether [that

argument] could succeed.” Id. That express limitation deprives Schaffner of any broader applicability.

In contrast to the plaintiff in Schaffner, Durnell has

argued all along that FIFRA requires Monsanto to

seek EPA approval for a modified Roundup label that

includes a cancer warning. Indeed, that conclusion is

compelled by Bates. There, the Court made clear that

“manufacturers have a continuing obligation to adhere

to FIFRA’s labeling requirements.” 544 U.S. at 438.

“[I]t is unlawful under the statute to sell a pesticide

that is registered but nevertheless misbranded.” Id.

Bates thus requires a manufacturer of a registeredbut-misbranded pesticide to fix the issue, “including

by seeking EPA approval to amend a label that does

not contain all ‘necessary warnings or cautionary

statements.’ ” SG Hardeman Br. 2 (quoting Bates,

544 U.S. at 438-39). FIFRA and its regulatory regime

thus “contemplate[ ] that pesticide labels will evolve

over time, as manufacturers gain more information.”

Bates, 544 U.S. at 451; see SG Hardeman Br. 12 n.3.13

13 Manufacturers have seized on that flexibility. “EPA has

repeatedly permitted pesticide manufacturers . . . to add notices

related to cancer to their products’ labels.” Hardeman, 997

F.3d at 959. For example, under 40 C.F.R. § 152.46(a), “Bayer

2. Because of the way it was argued, Schaffner

rests on the assumption that Monsanto had no option

to update Roundup’s labeling. So to rely on Schaffner

here, Monsanto echoes that assumption, asserting

(at 20-21, 24) that Roundup’s labeling is “lock[ed] . . .

in place.” But Monsanto’s assumption is false and was

disproved in this case.

Monsanto’s own actions put the lie to its claim that

Roundup’s labeling cannot be changed: The company

has updated Roundup’s labeling 44 times. And when

Monsanto thought it might rid itself of future liability

through a settlement of federal multidistrict litigation,

it proposed to seek EPA permission to add information

about Roundup’s cancer risks to its labeling. Supra

p. 4. The company can add a cancer warning at any

time; it has made the business decision not to.

Monsanto focuses (at 20, 29) on 40 C.F.R. § 152.44.

But that regulation does not forbid the company from

warning of Roundup’s cancer risks; it just establishes

procedures for manufacturers to update their labels.

For example, § 152.44(a) provides that a manufacturer

generally must submit proposed labeling changes for

EPA approval, and § 152.44(b) gives EPA discretion to

waive that requirement. So § 152.44 not only permits

Monsanto to add a cancer warning to Roundup’s labeling, but explains how to do so—indeed, the title of that

regulation is “Application for amended registration.”

CropScience notified EPA ‘of a minor labeling amendment for

LARVIN Technical,’ informing EPA that ‘as required by California Proposition 65, the following statement has been added to the

label, “This product contains a chemical known to the state of

California to cause cancer.” ’ ” 997 F.3d at 959 n.10 (cleaned up).

Had Monsanto—now a Bayer subsidiary—taken the same approach

here, it could have prevented Durnell’s injuries.

The United States has explained that nothing in

FIFRA or its implementing regulations prevents

Monsanto from warning of Roundup’s cancer risks.

“In the FIFRA registration process,” where EPA reviews

and approves a manufacturer’s proposed pesticide

label, “EPA neither requires nor precludes any specific

chronic-risk warnings, through regulation or otherwise.” SG Hardeman Br. 19.

II. The Decision Below Is Correct

A. Durnell’s Failure-To-Warn Claim Is Not

Expressly Preempted

The court of appeals was correct: “Missouri’s strict

liability failure to warn cause of action is fully consistent” with FIFRA’s requirements. App.6. Durnell’s

claim thus is “equivalent to, and fully consistent with,

FIFRA’s misbranding provisions,” Bates, 544 U.S. at

447, not preempted.

First, Durnell had to prove at trial that Monsanto

failed to “give an adequate warning of the danger”

posed by Roundup. 5 Tr. 3378:21-22; App.6. That

duty tracks § 136(q)(1)(G), which requires a warning

“necessary” and “adequate to protect health.”

Second, Durnell’s claim requires warnings in

narrower circumstances than FIFRA does. FIFRA

requires adequate safety warnings no matter the consumer’s knowledge. § 136(q)(1)(G). Missouri requires

a warning only if the product is “unreasonably

dangerous when put to a reasonably anticipated use

without knowledge of its characteristics.” 5 Tr. 3378:1921; see Moore, 332 S.W.3d at 756; App.6-7. So

Durnell’s claim, if anything, imposes less of a duty

on Monsanto than FIFRA does.

Because Durnell’s failure-to-warn claim parallels

FIFRA’s misbranding provisions, it functionally

enforces the statutory misbranding prohibition. “[A]

state cause of action that seeks to enforce” FIFRA’s

misbranding provisions “ ‘does not impose a requirement that is “different from, or in addition to,” requirements under federal law,’ ” and so is not preempted.

Bates, 544 U.S. at 447-48 (quoting Medtronic, Inc. v.

Lohr, 518 U.S. 470, 513 (1996) (O’Connor, J., concurring in part and dissenting in part)).

B. Monsanto’s Express-Preemption Arguments

Lack Merit

Monsanto’s cornerstone argument is that EPA’s

decision to register a pesticide and approve its label

imposes a preemptive “requirement” under FIFRA.

That argument always has been “incorrect,” SG

Hardeman Br. 6-7; see infra pp. 25-27, but it is even

less persuasive now that the Ninth Circuit has vacated

the reasoning EPA used when registering glyphosate.

1. After an 11-year re-registration process that

began in 2009, EPA failed to sustain its initial view

that glyphosate was not likely to cause cancer. The

Ninth Circuit held that EPA lacked substantial

evidence for that position and that its reasoning was

“the hallmark of arbitrary action.” NRDC, 38 F.4th

at 51.

Though glyphosate remains registered, whatever

preemptive effect registration might have had has

been nullified. An agency decision that has been

vacated has no legal effect. “In essence, a vacatur

order takes the unlawful agency action off the books,

which is an entirely appropriate response when a

plaintiff successfully establishes that the agency’s

conduct violates the law.” Kiakombua v. Wolf, 498 F.

Supp. 3d 1, 50 (D.D.C. 2020) (Jackson, J.) (cleaned up).

The D.C. Circuit therefore has vacated an agency

order because it “relied not only on [an already vacated

order] but also on its defective reasoning.” WorldCom,

Inc. v. FCC, 246 F.3d 690, 696 (D.C. Cir. 2001).

EPA’s now-vacated conclusion that glyphosate is not

carcinogenic thus cannot support preemption. Even

so, Monsanto cites (at 11) EPA’s statement that its

“underlying scientific findings regarding glyphosate,

including its finding that glyphosate is not likely to

be carcinogenic in humans, remain the same.” EPA,

EPA Withdraws Glyphosate Interim Decision (Sept.

23, 2022), https://perma.cc/EU77-LMGN. That bare

(and incorrect) statement has no legal effect, much

less a preemptive one. As the United States itself has

explained, “EPA’s repeated statements that glyphosate is unlikely to be carcinogenic to humans” “do[ ]

not alone preempt enforcement of state tort law.”

SG Hardeman Br. 12-13.

2. Even setting vacatur aside, EPA’s decision to

tort liability. Registration is not even the last word on

whether the pesticide’s labeling is misbranded. The

agency determines whether a pesticide’s warnings

are “necessary” and “adequate to protect [public]

health” based on material the manufacturer submits.

§ 136(q)(1)(G); see § 136a(c)(2), (c)(5)(B)-(D). If other

information, like an “incident[ ] involving a pesticide’s

toxic effects,” shows the labeling to be misbranded,

Bates, 544 U.S. at 439, EPA’s prior registration decision offers a manufacturer no safe harbor: “EPA may

institute cancellation proceedings and take other

enforcement action if it determines that a registered

pesticide is misbranded.” Id. (citation omitted).

A manufacturer cannot use EPA’s registration of

its pesticide “as a defense for the commission of any

offense under [FIFRA],” including the misbranding

offense. § 136a(f )(2). Rather, registration is only “prima

facie evidence” that the pesticide is not misbranded.

Id.14 As a result, even if EPA approved a label, “a

judge or jury” could “find that [the] same label violates

FIFRA.” Hardeman, 997 F.3d at 956.

That is why Bates recognized that a pesticide can

be “registered but nevertheless misbranded.” 544 U.S.

at 438. “Against that backdrop,” the United States

has explained, “EPA’s approval of pesticide labeling

without a chronic-risk warning is not naturally

characterized as a FIFRA ‘requirement’ that no such

warning appear.” SG Hardeman Br. 11-12. And for

good reason: EPA’s registration decisions are “based

in significant part on proposed labeling and scientific

studies submitted by the manufacturer.” Id. at 12 n.3.

Those submissions may be inaccurate, incomplete, or

proven inadequate based on later research.

If a pesticide is “registered but nevertheless misbranded,” the manufacturer has a duty to update

its label. Id. at 2. FIFRA does not authorize, much

less require, a manufacturer to retain the label of

a misbranded pesticide just because EPA registered

the pesticide. Indeed, retaining a registered but

misbranded label is not a “requirement” of FIFRA—it

is a violation. And registration does not establish any

relevant “requirement” that might supersede a duty

under state law. For this reason, EPA’s registration

of glyphosate does not preempt Durnell’s claims. See

Hardeman, 997 F.3d at 956 (“[B]ecause EPA’s labeling

14 Section 136a(f )(2) provides in full:

(2) Registration not a defense

In no event shall registration of an article be construed

as a defense for the commission of any offense under this

subchapter. As long as no cancellation proceedings are in

effect registration of a pesticide shall be prima facie evidence

that the pesticide, its labeling and packaging comply with

the registration provisions of the subchapter.

determinations are not dispositive of FIFRA compliance, they similarly are not conclusive as to which

common law requirements are ‘in addition to or

different from’ the requirements imposed by FIFRA.”);

Indian Brand Farms, Inc. v. Novartis Crop Prot. Inc.,

617 F.3d 207, 222 (3d Cir. 2010) (similar).

3. Monsanto’s counterarguments lack merit. First,

the company contends that § 136a(f )(2) “has ‘no bearing on’ ” preemption. Pet. 28 (quoting MacDonald v.

Monsanto Co., 27 F.3d 1021, 1025 n.4 (5th Cir. 1994)).

“But the fact that ‘EPA’s labeling determinations are

not dispositive of FIFRA compliance’ supports the . . .

conclusion that, for purposes of preemption . . . , those

determinations ‘similarly are not conclusive as to

which common law requirements are “in addition to or

different from” the requirements imposed by FIFRA.’ ”

SG Hardeman Br. 8-9 (quoting Hardeman, 997 F.3d

at 956). Just as a manufacturer with a registered

pesticide still may be liable for misbranding under

FIFRA, a manufacturer with a registered pesticide

still may be liable under state law. See Bates, 544 U.S.

at 451 (discussing “[p]rivate remedies that enforce

federal misbranding requirements”).

Monsanto relies (at 28) on MacDonald, in which a

pre-Bates panel of the Fifth Circuit adopted its view of

§ 136a(f )(2). But MacDonald, decided 11 years before

Bates, is no longer good law. See Indian Brand Farms,

617 F.3d at 221-22 (“Bates introduced a different

analysis of FIFRA preemption, one that compels us to

depart from this pre-Bates precedent.”).

Second, § 136a(f )(2) also shows why Monsanto

cannot rely (at 25-26) on Riegel v. Medtronic, Inc.,

552 U.S. 312 (2008). In Riegel, the Court held that

FDA’s premarket medical-device approval imposes

“requirements” under the preemption clause of a

Medical Device statute and preempts state failure-towarn claims based on inconsistent duties. Id. at 32223, 327-30. FDA’s premarket approval of the riskiest

medical devices serves as conclusive evidence that

“the approved form [of the devices] provides a reasonable assurance of safety and effectiveness.” Id. at 323.

In contrast, FIFRA provides that registration is only

“prima facie evidence” of compliance, § 136a(f )(2),

not proof the labeling is “adequate to protect health,”

§ 136(q)(1)(F), (G). And because a manufacturer

with a registered product still could be liable for

misbranding, it could be liable for state-law claims

(like Durnell’s) “that are fully consistent with federal

requirements.” Bates, 544 U.S. at 452.

More generally, the statutory schemes in Riegel and

here are meaningfully different. The Medical Device

Amendments “swept back some state obligations

and imposed a regime of detailed federal oversight,”

Riegel, 552 U.S. at 316, while FIFRA “authorizes a

relatively decentralized scheme” that leaves States

with broad power to regulate pesticide products—

including the power to ban the sale of unsafe, but

registered, pesticides, Bates, 544 U.S. at 450 (citing

§ 136v(a)). Thus, “different federal statutes and regulations may . . . lead to different pre-emption results.”

PLIVA, Inc. v. Mensing, 564 U.S. 604, 626 (2011).

For medical devices, “premarket approval is specific

to individual devices,” requiring FDA to determine the

device “offers a reasonable assurance of safety and

effectiveness.” Riegel, 552 U.S. at 322-23. By contrast,

FIFRA’s misbranding provisions impose only “general

standards.” Bates, 544 U.S. at 453 n.27; see Lohr, 518

U.S. at 501 (no preemption when federal requirements

“reflect[ed] important but entirely generic concerns

about device regulation generally”). And EPA has

acknowledged that it has not specifically evaluated

glyphosate “formulations” like Roundup. See supra

pp. 10-11; Hardeman, 997 F.3d at 952 (“EPA explained

that there are few research projects that have

attempted to directly compare technical grade glyphosate to the formulations under the same experimental

design, but if at any time, information becomes available that indicates adverse human health effects of

concern for exposure to glyphosate or its formulations,

EPA intends to review it and determine the appropriate regulatory action.”) (cleaned up).

Third, the company argues (at 33) that permitting

States to require cancer warnings would undermine

Congress’s goal of national “uniformity” in pesticide

labeling. But Bates cautioned against “overstat[ing]

the degree of uniformity and centralization that

characterizes FIFRA,” noting that “[FIFRA] authorizes

a relatively decentralized scheme that preserves a broad

role for state regulation.” 544 U.S. at 450. So to Bates,

“it seem[ed] unlikely that Congress considered a relatively obscure provision like § 136v(b) to give pesticide

manufacturers virtual immunity from certain forms of

tort liability.” Id.

To be sure, FIFRA’s preemption provision plays

“a narrow, but still important, role”: it bars state-law

labeling requirements that conflict with federal ones.

Id. at 452. “For example, a failure-to-warn claim alleging that a given pesticide’s label should have stated

‘DANGER’ instead of the more subdued ‘CAUTION’

would be pre-empted because it is inconsistent with 40

CFR § 156.64 (2004), which specifically assigns these

warnings to particular classes of pesticides based on

their toxicity.” Id. at 453.

No such federal regulation exists for chronic-risk

warnings about glyphosate. EPA could have, through a

“notice-and-comment process,” issued “binding requirements or prohibitions governing chronic-hazard warnings for glyphosate.” SG Hardeman Br. 13 n.4. But

“it did not.” Id. So FIFRA’s “narrow, but still important,”

preemption provision does not apply.

The existing regulatory structure confirms that

FIFRA already accommodates meaningful variation.

For example, Roundup Power Max’s label discusses

“requirements specific to your State or Tribe,”

instructing users to “consult the agency responsible

for pesticide regulation.” App.30a. That label also

includes state-specific deviations—for example, special

restrictions on aerial spraying in California and

Arkansas, App.35a-40a, or different application rates

for sugarcane in Florida, Hawaii, Louisiana, and Texas,

App.42a-43a. Monsanto complains (at 34) about the

problem of 50 different state labeling regimes, but

never explains why it can offer state-specific advice for

sugarcane but not cancer.

C. Durnell’s Failure-To-Warn Claim Is Not

Impliedly Preempted

The court of appeals also was right that Monsanto

cannot show implied preemption. As the court noted,

the company did not even try to carry its heavy burden:

“The record contains no evidence that Monsanto

either informed the EPA of the justifications for a

change to its warning label or that the EPA has

informed Monsanto it would not approve such a

warning.” App.9.

Monsanto draws its implied-preemption arguments

from prescription-drug cases under the Federal Food,

Drug, and Cosmetic Act. This Court conducts an

implied-preemption analysis in such cases because

Congress has “declined to enact [an express-preemption]

provision for prescription drugs.” Wyeth v. Levine, 555

U.S. 555, 567 (2009). Those cases have little relevance

here because FIFRA has an express-preemption provision, and implied preemption likely does not apply.

See Bates, 544 U.S. at 459 (Thomas, J., concurring in

judgment in part and dissenting in part) (favorably

noting “this Court’s increasing reluctance to expand

federal statutes beyond their terms through doctrines

of implied pre-emption”). But even setting that

threshold issue aside, Monsanto’s implied-preemption

arguments lack merit.

1. Monsanto’s first implied-preemption theory (at

28-30) is that it could not add a warning to Roundup’s

labels without EPA’s approval. But the company

misunderstands the case from which it derives this

supposed rule: In PLIVA, the Court addressed implied

preemption in the generic-drug context. Under the

FDCA, FDA imposes a “duty of sameness” on genericdrug labels, which must always match the label of the

brand-name equivalent drug. 564 U.S. at 616. If a

generic-drug manufacturer wants to update a label, it

must “ask the agency to work toward strengthening

the label that applies to both the generic and brandname equivalent drug.” Id. The manufacturer has

no right to update the label on its own, so when a

state-law claim imposes a duty to change the label, it

is impliedly preempted.

Unlike generic-drug manufacturers, which have a

“federal-law duty to keep the label the same,” id. at

618, pesticide manufacturers “have a continuing obligation to adhere to FIFRA’s labeling requirements,”

Bates, 544 U.S. at 438. The statute “contemplates

that pesticide labels will evolve over time, as manufacturers gain more information about their products’

performance in diverse settings.” Id. at 451. When an

updated label is necessary, a manufacturer generally

must submit the revisions to EPA. See § 136a(f )(1);

40 C.F.R. § 152.50(e). And when a manufacturer’s

proposed label is not misbranded, FIFRA provides

that EPA “shall” approve it. § 136a(f )(1).

EPA has made clear it would approve a label

warning of Roundup’s cancer risks. In its April 2022

Letter, the agency said that, if a company like

Monsanto asked to include a warning that IARC

“classified glyphosate as probably carcinogenic to

humans,” “this revised language could be approved by

EPA” because it would not be misbranded. RA57-58;

see SG Hardeman Br. 14. As a result, federal law

imposes no competing “duty to keep the label the same,”

PLIVA, 564 U.S. at 618, and Monsanto’s argument

lacks merit.

2. Monsanto’s second theory (at 30-32) is that

it cannot add a cancer warning to Roundup labels

because EPA would not accept it. Again under the

FDCA, failure-to-warn claims are preempted when

there is “clear evidence” that FDA would not have

approved the warning that state law requires. Wyeth,

555 U.S. at 571. The only sources of “clear evidence”

of what an agency would do in such a hypothetical

situation “are agency actions taken pursuant to the

FDA’s congressionally delegated authority”: “noticeand-comment rulemaking,” an order “formally rejecting a warning label,” or “other agency action carrying

the force of law.” Merck Sharp & Dohme Corp. v.

Albrecht, 587 U.S. 299, 315-16 (2019).

There is no “clear evidence” showing Durnell’s

failure-to-warn claim is preempted. EPA has promulgated no regulation requiring certain warnings on

glyphosate-based product labels and barring others.

Nor has the agency taken other formal action rejecting

a warning about the cancer risks of Roundup. Instead,

the agency said in its April 2022 Letter that, if a company like Monsanto asked to include a warning that

IARC “classified glyphosate as probably carcinogenic

to humans,” “this revised language could be approved

by EPA.” RA57-58. That is the opposite of “clear

evidence” showing that Durnell’s claim regarding

formulated Roundup is preempted.

Monsanto’s argument also is incorrect on its face.

Although the company suggests (at 30 n.7) that

Durnell never requested the specific warning in the

April 2022 Letter, Durnell’s claims, like any commonlaw claim, did not turn on any specific warning. See

Moore, 332 S.W.3d at 759 (Missouri failure-to-warn

plaintiff does not bear burden “to propose the wording

of an adequate warning to make a submissible case”).

Monsanto needed only to provide an adequate warning of Roundup’s health risks. It refused even that.

III. The Petition Meets No Other Traditional

Reason For Certiorari

The petition presents one company’s attempt to

avoid further tort claims. And no company is less

deserving of such sweeping immunity than Monsanto.

1. As Monsanto itself acknowledges (at 33), this

case involves “a single product line.” The company

tries to infuse this case with broader legal import by

drawing on other statutes with preemption provisions

that prohibit state requirements “in addition to or

different from” federal ones. But what matters is not

the wording, but how the provision functions within

each statutory scheme.

For example, Monsanto relies (at 35-36) on cases

decided under the Federal Meat Inspection Act. That

Act “establishes an elaborate system of inspecting

live animals and carcasses,” and “[o]ver the years,

the [Department of Agriculture’s Food Safety and

Inspection Service] has issued extensive regulations”

fleshing out that system. National Meat Ass’n v.

Harris, 565 U.S. 452, 455-56 (2012) (cleaned up).

Because that Act and its regulations impose many

requirements, its preemption provision necessarily

“sweeps widely” when blocking applications of additional or different state requirements. Id. at 459-60.

Here, by contrast, EPA has promulgated “relatively

few regulations,” so FIFRA’s preemption provision is

“narrow.” Bates, 544 U.S. at 452, 453 n.28.

2. Monsanto’s 50-year history of failing to test

whether long-term use of formulated Roundup causes

cancer further counsels against review. The company’s

position would bar essentially all failure-to-warn

claims based on a pesticide’s “labeling.” But as Bates

observed, “it seems unlikely that Congress considered

a relatively obscure provision like § 136v(b) to give

pesticide manufacturers virtual immunity from

certain forms of tort liability.” 544 U.S. at 450.

That immunity also would hinder the functioning

of FIFRA: state-tort actions “may aid in the exposure

of new dangers associated with pesticides,” giving

manufacturers “added dynamic incentives to continue

to keep abreast of all possible injuries stemming

from use of their product so as to forestall such actions

through product improvement.” Id. at 451. Just so

with Durnell, who used Roundup products for two

decades around his community. His extended exposure, and that of thousands of others, can help inform

EPA about the long-term effects of glyphosate-based

products like Roundup and aid the agency in carrying

out “its task of assessing the environmental and health

dangers posed by pesticides.” Id. at 440.

That task is exceptionally important in a case

like this. Rather than test formulated Roundup for

long-term cancer risks or provide warnings, Monsanto

instead has waged a decades-long campaign to mislead the scientific community and the public about

the weedkiller’s cancer risks. At the same time, the

company has sought to avoid financial responsibility

for the harms to human health that its product has

caused and that warnings might have avoided. Based

on such evidence, five appellate courts (Johnson,15

Hardeman,16 Pilliod,17 Anderson,18 and Caranci19)

have upheld jury verdicts assessing significant punitive

damages against Monsanto for its callous conduct.

CONCLUSION

The petition for a writ of certiorari should be denied.

$250 million in punitive damages reduced to just over

$10 million. Johnson v. Monsanto Co., 266 Cal. Rptr. 3d 111, 120,

129, 136 (Ct. App. 2020).

16 $75 million in punitive damages reduced to $20 million.

Hardeman, 997 F.3d at 970.

17 $2 billion in punitive damages to two plaintiffs reduced to

approximately $70 million. Pilliod, 282 Cal. Rptr. 3d at 697-98,

720.

18 $1.5 billion in punitive damages to three plaintiffs remitted

to $549.9 million and affirmed in full. Anderson v. Monsanto Co.,

2025 WL 1497539, at *2-3, *31 (Mo. Ct. App. May 27, 2025).

19 $150 million in punitive damages affirmed in full. Caranci

v. Monsanto Co., --- A.3d ---, 2025 WL 1340970, at *14-15 (Pa.

Super. Ct. May 8, 2025).

Respectfully submitted,

JAMES G. ONDER

W. WYLIE BLAIR

GREGORY J. PALS

MARK E. BERNS

ONDERLAW, LLC

110 E. Lockwood Avenue

St. Louis, Missouri 63119

(314) 963-9000

T. ROE FRAZER II

THOMAS ROE FRAZER III

JAMES GRANT LABAR

FRAZER PLC

30 Burton Hills Boulevard

Suite 450

Nashville, Tennessee 37215

(615) 647-6464

June 9, 2025

DAVID C. FREDERICK

Counsel of Record

DEREK C. REINBOLD

KELLOGG, HANSEN, TODD,

FIGEL & FREDERICK,

P.L.L.C.

1615 M Street, N.W.

Suite 400

Washington, D.C. 20036

(202) 326-7900

(dfrederick@kellogghansen.com)

APPENDIX

TABLE OF CONTENTS

Page

Pl.’s Trial Exhibits (Durnell v. Monsanto Co.,

No. 1922-CC00221 (Mo. Cir. Ct., St. Louis)):

P-0151 .................................................................. 1a

P-0156 .................................................................. 9a

P-0226 ................................................................ 11a

P-0318 ................................................................ 18a

P-0771 ................................................................ 19a

P-1340 (excerpts) ............................................... 27a

P-2582 (excerpt) ................................................. 44a

P-3047 ................................................................ 49a

[Plaintiff ’s Trial

Exhibit

P-0151]

Message

From:

Sent:

To:

MARK A MARTENS

4/19/1999 8:49:08 AM

LARRY D KIER; WILLIAM F HEYDENS;

ALAN G E WILSON; DONNA R FARMER

CC:

STEPHEN J WRATTEN; CAM S VERDIN;

WILLIAM GRAHAM; RICHARD P

GARNETT

Subject: Re: Meeting Minutes 2/25

Donna,

Thanks for this, it accurately reflects the situation.

Please take note of the following update:

I received from prof. Parry the signed secrecy agreement.

As a response I sent him a letter of authorisation

and all relevant reports and publications re mutagenicity of glyphosate, its formulations and the

surfactants for which we have mutagenicity testing

data.

The list was based on the foulder that was composed

for Gabriele and the German monograph on Glyphosate:

Glyphosate formulations Roundup:

– Ames test, Monsanto report ML-91-440

– Mouse micronucleus test, Monsanto report ML91-434/437

– Comet test on Rana tadpoles, Clements et al.,

Environmental and Molecular Mutagenesis, 29,

277(1997)

– Drosophila SLRL, Kale et al., Environmental and

Molecular Mutagenesis, 25, 148(1995)

– SCE, Vigfusson and Vyse, Mutation Research, 79,

53(1980)

Direct:

– Ames test, Monsanto report ML-91-442

– Mouse micronucleus test. Monsanto report ML91-436/439

Rodeo:

– Ames test, Monsanto report ML-91-441

– Mouse micronucleus test, Monsanto report ML91-435/438

Glifos:

– Ames test, BioAgri report G1.1-050/96

– Mouse micronucleus test, BioAgri report G1.2060/96

Active ingredient (glyphosate):

– Ames test, rec-assay, HGPRT test, UDS test,

in-vivo cytogenetics. Li and Long, Fundamental and

Applied Toxicology, 10, 537(1988)

– In vitro cytogenetics in human lymphocytes.

NOTOX report 141918

– Ames test, Jensen, Scantox report 12323 (1991)

– Mouse lymphoma test, Jensen, Scantox report

12325 (1991)

– Mouse micronucleus test, Jensen, Scantox report

12324 (1991)

– Mouse dominant lethal test, Monsanto report

IR-79-014

Surfactants:

Polyethoxylated tallowamine (MON 0818):

– Ames test, Monsanto report ML-89-461

– Mouse micronucleus test, Monsanto report ML89-463

C8-C10 alkyl sulphate IPA salt (MON 8080):

– Ames test, Monsanto report ML-80-294

Dodigen 4022:

– Ames test, Hoechst report 92.0336

– In-vitro cytogenetics, Hoechst report 92.0337

Tween 20:

– Mouse lymphoma test, Abstract P46, Environmental and Molecular Mutagenesis, 3(3), 320(1981)

Tween 80:

– Mouse micronucleus test, Jenssen and Ramel,

Mutation Research, 75,191(1980)

Via separate mail I sent him the composition of all

the formulations tested and data on the chemistry

of the surfactants (not too detailed).

So, in principle he will start his review this week.

Once the review is ready it will be a good idea to

have Larry visit Jim Parry for an overall discussion.

Regards, Mark.

--------------------------Reply Separator-------------------------Subject: Meeting Minutes 2/25

Author: DONNA R FARMER at MONSL125

Date:

4/17/99 7:25 AM

Please find the meeting minutes and actions from

our 2/25 meeting below.

We need to discuss where we are on each of these

topics as well as well as finalize a letter of comment

to the German Addendum. Steve has provided some

valuable comments in a recent message. I will draft

a letter and provide for discussion.

Bill – what is the drop dead date you need these

comments?

Cam where are we in getting this meeting set up?

Donna

1) Update on the German Addendum

Steve Wratten joined us for this discussion. We

understand that the Germans current position on

the effects observed in the various studies with

the formulatons as described in the open literature

do not indicate a mutagenic response but rather a

cytotoxic response associated with the surfactant(s).

Glyphosate, it’s salts, the G3 and G4 formulations

(with the Dodigen surfactant) and Rodeo are free

and clear.

For those formulations/surfactants that can be

tested up to the limit levels per OECD guidelines

and produce no toxicity such as the Dodigen (the

major surfactant in MON 52276) they would be

viewed favorably.

Roundup (with MON 0818), Roundup Ultra, the

etheramine-based formulations and other formu-lations either do not meet this standard or the

possiblity that they will is low.

It will be up to each country to decide which formulations it does and doesn’t want and they could use

this for that purpose.

It was felt that this position should not be a regulatory endpoint, it is not defensible and that once the

German Addendum is made public comments and a

response should be prepared for the ECCO Meetings

preferably before 17th May (Mammalian Tox Meeting). Note that the Conclusion meetings are not

until the 18th October – Donna will coordinate this

response when a copy of the German Addendum is

received.

2) Testing program – what do we test? formulations. .surfactants? When is data needed? Discussion is dependant upon info from agenda item # 1

No further mutagenicity testing is needed for MON

52276.

Steps have been taken to acquire the cocoamine

surfactant used in MON 35012/Roundup 2000 sold

in Denmark for testing in the microames and micromicronucleus assays. In addition based on the

concern for cytotoxicity it was recommended to

also to run this surfactant thru the NRU assay (this

assay addresses cytotoxicity and has a good correlation with the oral LD50). – Donna will coordinate

and monitor these tests

Management supports the investigation of MON

35050 toxicity to the liver and kidneys to address

the findings in the Peluso study. Therfore it was

recommended to move forward with a study . . .

evaluating liver and kidney histology, serum

enzymes as well as glutathionine levels following

high-dose, i.p. exposures of the test material. – Alan

will draft and circulate a protocol

Donna will followup with Bill Graham to get the

details/and clarification behind his statement below

(in green) as to what is expected, on what materials

and by when. “We will need to demonstrate clearly

negative Mutagenic (and cytogenic?) results for all

the formulations we sell in Europe. These will certainly be required by end 2000 but public pressure

may require us to do them earlier.”

3) “Detergent-like molecule” testing program? Is

this still something we need to do? When do we

start? Discussion is dependent info from agenda

item #1

In light of the position taken by the German government this investigation maybe even more important

than before and could possibly be conducted by

Dr. Parry?

Dr. Williams?

Donna will arrange for further meetings to discuss/

design this program

4) Global experts

Review Dr. Parry’s analyis – what is our next

step? Dr. Parry concluded on his evaluation of

the four articles that glyphosate is capable of

producing genotoxicity both in vivo and in vitro

by a mechanism based upon the production of

oxidative damage.

The data that Dr. Parry evaluated is limited and

is not consistant with other better conducted

studies. In order to move Dr. Parry from his

position we will need to provide him with the

additional information as well as asking him to

critically evalute the quality of all the data

including the open literature studies.

As a followup Mark will contact Dr. Parry,

discuss with him the existance of additional

data and ask him to evaluate the full package.

Mark will also explore his interest (if we can

turn his opinion around) in being a spokesperson for us for these type of issues.

Larry as well as others will be available to

discuss the data with Parry as needed by e-mail,

phone or in person or all the above.

Dr. Williams – discuss the outcome of the

Cantox meeting

The panel concluded that glyphosate and

Roundup were not mutagenic. That in the

evaluation of these types of studies criteria

should be set. . . up front in the evaluation

process as to what makes an acceptable study

and what does not – this is to be included in t

he manuscript as well as a weight of evidence

approach.

5) Lioi followup

An analysis of what was tested in the Lioi studies

was deemed important. Therefore it was recommended that Monsanto EU or Italy contact Lioi

and try to get a sample of what they used in their

study as well as getting a sample from the company that Lioi did. Donna will contact Gabrielle

to ask him to make the requests.

[Plaintiff ’s Trial

Exhibit

P-0156]

Message

From:

HEYDENS, WILLIAM F [FND/1000]

[/O=MONSANTO/OU=NA-1000-01/CN=

RECIPIENTS/CN=230737]

Sent:

9/16/1999 6:18:36 PM

To:

MARTENS, MARK A [FND/5045]

[/0=MONSANTO/OU=EA-5040-01/CN=

RECIPIENTS/CN=21606]; 'KIER, LARRY

D [NCP/1000]' [/O=MONSANTO/OU=

GLB-STL/CN=LEGACY ADDRESSES/CN=

33322]; 'FARMER, DONNA R [FND/1000]'

[/O=MONSANTO/OU=GLB-STL/CN=

LEGACY ADDRESSES/CN=180070]

CC:

'HEYDENS, WILLIAM F [FND/1000]'

[/O=MONSANTO/OU=GLB-STL/CN=

LEGACY ADDRESSES/CN=230737]

Subject: RE: Parry report

Mark, All,

I have read the report and agree with the comments –

there are various things that can be done to improve

the report.

However, let’s step back and look at what we are

really trying to achieve here. We want to find/develop

someone who is comfortable with the genetox profile

of glyphosate/Roundup and who can be influential

with regulators and Scientific Outreach operations

when genetox. issues arise. My read is that Parry is

not currently such a person, and it would take quite

10a

some time and $$$/studies to get him there. We

simply aren’t going to do the studies Parry suggests.

Mark, do you think Parry can become a strong advocate without doing this work Parry? If not, we should

seriously start looking for one or more other individuals to work with. Even if we think we can eventually

bring Parry around closer to where we need him, we

should be currently looking for a second/back-up

genetox. supporter. We have not made much progress

and are currently very vulnerable in this area. We

have time to fix that, but only if we make this a high

priority now.

Bill

------Original Message-----From: MARTENS, MARK A [FND/5045]

Sent:

Thursday, September 16, 1999 2:02 AM

To:

KIER, LARRY D [NCP/1000]; FARMER,

DONNA R [FND/1000]

Cc:

HEYDENS, WILLIAM F [FND/1000]

Subject: Parry report

Importance: High

Larry and Donna,

I would like to get some feedback to Jim Parry on

his report. I sent you my comments but didn’t get a

reaction. Can I get your opinions and then have a

discussion on the action to take?

Regards, Mark

11a

[Plaintiff ’s Trial

Exhibit

P-0226]

Message

From:

FARMER, DONNA R [AG/1000]

[/O=MONSANTO/OU=NA-1000-01/

CN=RECIPIENTS/CN=180070]

Sent:

9/21/2009 5:12:07 PM

To:

COMBEST, JOHN C [AG/1000]

[john.c.combest@Monsanto.com]

Subject: RE: Roundup article in Fremantle Herald

I didn’t find anything on the Australian site either

. . .however take this question 5. It is not Roundup

that is taken up it is glyphosate. It stops the synthesis

of 3 amino acids (they are used to make proteins) and

this “process” is also found in microbes and fungi.

5. How does Roundup work?

Roundup is taken up through the leaves and moves

in the sap flow throughout the plant. It stops the

production of proteins so that the plant starves.

This process is found only in plants; Roundup has

extremely low toxicity to humans and wildlife.

Or this – you cannot say that Roundup does not cause

cancer . . . we have not done carcinogenicity studies

with “Roundup”.

2. Will Roundup harm my family or me?

Based on the results of short term and long term

testing, it can be concluded that Roundup poses no

danger to human health when used according to label

12a

directions. In long term exposure studies of animals,

Roundup did not cause cancer, birth defects or adverse

reproductive changes at dose levels far in excess of

likely exposure.

I will follow up with the Monsanto folks who interface

with Scotts . . . they are aware that Scotts does these

things.

Donna

------Original Message-----From:

COMBEST, JOHN C [AG/1000]

Sent:

Monday, September 21, 2009 11:07 AM

To:

FARMER, DONNA R [AG/1000]

Subject: RE: Roundup article in Fremantle Herald

I did not find any reference on their main (US) page to

“biodegradable.”

------Original Message-----From:

FARMER, DONNA R [AG/1000]

Sent:

Monday, September 21, 2009 11:06 AM

To:

COMBEST, JOHN C [AG/1000]

Subject: RE: Roundup article in Fremantle Herald

Did you find the link?

This is to their Q&A and I can tell you they have a

number of things that a not acceptable.

http://www.scottsaustralia.com.au/FAQs/Roundup

13a

------Original Message-----From:

COMBEST, JOHN C [AG/1000]

Sent:

Monday, September 21, 2009 8:11 AM

To:

PERSON, JANICE L [AG/1030]; FARMER,

DONNA R [AG/1000]; HELSCHER,

THOMAS M [AG/1000]

Subject: Fw: Roundup article in Fremantle Herald

Janice and Donna,

Here’s the Australian thread, to the latest message.

John

------Original Message-----From:

LEADER, MICHAEL [AG/5020]

To:

ANDERSON, NEIL J [AG/5020];

MCNAUGHTON, HONI JANINE [AG/5020];

MCGREGOR, JOHN [AG/5020];

HELSCHER, THOMAS M [AG/1000]

Cc:

MCLEAN, KERYN [AG/5020]; TAYLOR,

IAN N [AG/5020]; ARMSTRONG, JANICE

M [AG/5340]; COMBEST, JOHN C

[AG/1000]

Sent:

Mon Sep 21 00:08:56 2009

Subject: RE: Roundup article in Fremantle Herald

Thanks Neil. Honi has already have pointed out the

flaws in the studies, but there can’t be any harm in

doing so again. Studies on the safety of Roundup is a

good approach, but I believe there are also some on

glyphosate’s benefits for the environment (even if the

14a

surfactant is not biodegradable).

Scott’s guy is blaming us too!!

It’s a shame the

Cheers

Michael

Michael Leader

Corporate and Regulatory Affairs Lead, Australia/

New Zealand

Level 12, 600 St Kilda Road; Melbourne VIC 3004

Email: michael.leader@monsanto.com

Ph: +61 3 9522 7121 | Mob: +61 458 985 995 1 Fax:

+61 3 9522 6121

<http://www.monsanto.com.au/>

From:

Sent:

To:

ANDERSON, NEIL 3 [AG/5020]

Monday, September 21, 2009 12:39 PM

MCNAUGHTON, HONI JANINE [AG/5020];

MCGREGOR, JOHN [AG/5020];

HELSCHER, THOMAS M [AG/1000]

Cc:

LEADER, MICHAEL [AG/5020]; MCLEAN,

KERYN [AG/5020]; TAYLOR, IAN N

[AG/5020]; ARMSTRONG, JANICE M

[AG/5340]; COMBEST, JOHN C [AG/1000]

Subject: RE: Roundup article in Fremantle Herald

Hi Honi

The reporter has printed the correct information that

“Glyphosate is biodegradable but the surfactant is

not”. However, then she goes into a sensationalism

15a

mode quoting “studies” that suggest Roundup is not

safe, which is probably derived from her interview

of the Fremantle activist. I feel the response to FH

needs to reiterate that her statement on biodegradability is correct, reiterate that Roundup is safe (and

provide references), and if there are flaws in any of the

studies quoted, point out these flaws.

Neil Anderson

QA & Formulations Lead, Asia Pacific

Monsanto Australia Ltd

Mobile phone: International 61409 382905; Australia

0409 382905

From:

Sent:

To:

MCNAUGHTON, HONI JANINE [AG/5020]

Monday, September 21, 2009 10:56 AM

MCGREGOR, JOHN [AG/5020]; ANDERSON,

NEIL J [AG/5020]; HELSCHER, THOMAS

M [AG/1000]

Cc:

LEADER, MICHAEL [AG/5020]; MCLEAN,

KERYN [AG/5020]; TAYLOR, IAN N

[AG/5020]; ARMSTRONG, JANICE M

[AG/5340]; COMBEST, JOHN C [AG/1000]

Subject: Roundup article in Fremantle Herald

Importance: High

Hi John and Neil

The article in question has appeared in the Fremantle

Herald as expected.

We need to think about our response.

suggestions:

Possible

16a

Letter from Scott’s to the FH reiterating the correct

information

Letter from Monsanto to FH reiterating the safety

of Roundup, etc

We may also need to compose a letter to all of Scott’s

Roundup customers (in WA) dismissing the allegations in the article. FH has a circulation of 20,000.

However, the FTO concern is here in WA during this

critical time.

Keryn: You may want to contact DAFWA and other

stakeholders as well as growers to explain what we

plan to do.

Ian: GSWG letter reiterating the safety of glyphosate from Steve Powles

Any actions and responses will need to be cleared with

the US.

We will need to have a phone call about this including

Scotts.

Please let me know your thoughts. I think you’ll agree

we need to jump on this.

Honi

Honi McNaughton

Public Affairs Manager

Monsanto Australia

PO Box 6051

St Kilda Central

Vic 3008

17a

Office: (03) 9522 7105

Fax: (03) 9522 6105

Mobile: 0418 324 894

<http://www.monsanto.com.au/>

Monsanto Twitter: http://www.twitter.com/monsantoco

<http://twitter.com/monsantoco>

Monsanto’s Blog: Monsanto According to Monsanto

<http://www.monsantoblog.com>

Monsanto For the Record: http://www.monsanto.

com/monsanto_today/for_the_record/default.asp

<http://www.monsanto.com/monsanto_today/

for_the_record/default.asp>

18a

[Plaintiff ’s Trial

Exhibit

P-0318]

Monsanto

FROM

G.J. Levinskas, G2WF 4-8809

(NAME—LOCATION—PHONE)

Dept. of Medicine & Environmental Health

DATE

: April 3, 1985

CC: G. Roush, Jr., M.D.

SUBJECT

REFERENCE :

: T. F. Evans

The following item of information is in addition to

those included in the current monthly report.

Senior management at EPA is reviewing a proposal

to classify glyphosate a a class C “possible human

carcinogen” because of kidney adenomas in male mice.

Dr. Marvin Kuschner will review kidney sections and

present his evaluation of them to EPA in an effort to

persuade the agency that the observed tumors are not

elated to glyphosate.

/s/ George J. Levinskas

George J. Levinskas

GJL/sfd

19a

[Plaintiff ’s Trial

Exhibit

P-0771]

Message

From:

PERSON, JANICE L [AG/1030] [/0=

MONSANTO/OU=NA-1000-01/CN=

RECIPIENTS/CN=JLPERS]

Sent:

12/24/2009 4:47:14 PM

To:

GRAHAM, JEFF A CROP [AG/1000]

[jeff.a.crop.graham@monsanto.com];

MURDOCK, SHEA W [AG/1000]

[shea.w.murdock@monsanto.com]

CC:

ADAMS, STEPHEN A [AG/1000]

[stephen.a.adams@monsanto.com];

WATSON, GREGORY R [AG/1000]

[gregory.r.watson@monsanto.com];

FARMER, DONNA R [AG/1000]

[donna.r.farmer@monsanto.com];

HEYDENS, WILLIAM F [AG/1000]

[william.f.heydens@monsanto.com];

COMBEST, JOHN C [AG/1000]

[john.c.combest@monsanto.com]

Subject: Re: MEDIA REQUEST: EPA labeling of

inert ingredients

Thanks. We have a couple of strings going here. I’m

trying to delay & get more info on the announcement.

Glenn & Donna have both suggested we need to get a

few folks together on this.

20a

---------------------------------Janice Person

Monsanto Public Affairs

PO 11425

Memphis, TN 38111

901-320-5760

------Original Message-----From:

GRAHAM, JEFF A CROP [AG/1000]

To:

MURDOCK, SHEA W [AG/1000]; PERSON,

JANICE L [AG/1030]

Cc:

ADAMS, STEPHEN A [AG/1000];

WATSON, GREGORY R [AG/1000];

FARMER, DONNA R [AG/1000];

HEYDENS, WILLIAM F [AG/1000]

Sent:

Thu Dec 24 10:44:57 2009

Subject: RE: MEDIA REQUEST: EPA labeling of

inert ingredients

Janice – the issue or topic is related to allegations that

have been going on for some time, that the pesticide

industry puts “bad” chemicals in their products that

currently do not have to be disclosed because they are

not the “active pesticidal ingredients”.

Roundup products have been particularly targeted

due to the fact that glyphosate is such a benign “pesticide” (yes – it is a pesticide as it controls pests, i.e.

weeds) and so a number of academics and agenda

driven researchers worldwide have claimed the inert

materials in Roundup products are more toxic/

eco-toxic than glyphosate. Specifically they have been

talking about the surfactant family in our Roundup

21a

products, ethoxylated alkylamines, (most specifically

ethoxylated tallow-derived amines).

I believe we need to discuss internally what the policy

implications would be of listing all the chemicals

in glyphosate products that are not glyphosate. Moreover we need to understand just how far reaching the

proposed policy might be. For example, is there a

cutoff level beyond what we do not have to report? It

is somewhat confusing to the lay public just what all

the components would mean.

For example for a basic Roundup formulation, i.e.

Roundup Original, the ingredients (in order of level or

concentration) are

Water

Glyphosate

15E0tallowamine ethoxylate

Isopropylamine

Polyethylene glycol

Ethylene glycol

Silicone Antifoam

Some trace level components PPM levels (if they were

required to be listed) are:

Some 10+ byproducts of the glyphosate manufacturing process

1,4-dioxane

N-nitroso-glyphosate

Formal dehyde

This is not exhaustive, and it may even be incorrect (I

just pulled it out of my head), but I think it makes the

point that depending on how far reaching the rule or

policy would be, we could end up with product labels

22a

with a whole list of chemicals, which in turn may confuse and even scare the public. In market research

done for Lawn & Garden, only about 25% of consumers identified glyphosate as the active ingredient in

Roundup L&G products and most were unable to say

if how long it controlled weeds; some said a year after

application and in fact it is probably less than a day

when incidentally applied to soil at recommended

rates.

It is also likely the lists would be used by activists

(NGO and government) to attack Roundup products

and the Roundup Ready franchise as well.

That’s it in a nutshell. If you like more information

then the people cc’d on this email are the group to pull

together.

Jeff Graham

Chemistry – Product and Process Technology

0291 / 02G

Office: 314.694.6310

Mobile: 314.422.4088

Fax: 314.694.9058

------Original Message-----From:

MURDOCK, SHEA W [AG/1000]

Sent:

Thursday, December 24, 2009 10:12 AM

To:

PERSON, JANICE L [AG/1030]; ADAMS,

STEPHEN A [AG/1000]; GRAHAM, JEFF

A CROP [AG/1000]; WATSON, GREGORY

R [AG/1000]

Subject: Re: MEDIA REQUEST: EPA labeling of

inert ingredients

23a

Janice.

I don’t have enough information to speak about what

the potential policy is or what the impacts will be to

our labeling.

I have included a few others that might have more

knowledge than I.

Shea

------Original Message-----From:

PERSON, JANICE L [AG/1030]

To:

STITH, GLENN A [AG/1000]; KIRK,

ANNETTE M [AG/1000]; ADAMS, TOM H

[AG/1000]; HELMS, MATTHEW J [AG/1000];

MURDOCK, SHEA W [AG/1000];

FARMER, DONNA R [AG/1000]; HEYDENS,

WILLIAM F [AG/1000]; STATER, STACEY

L [AG/1000]

Cc:

COMBEST, JOHN C [AG/1000]; KASPER,

GARRETT D [AG/1000]

Sent:

Wed Dec 23 23:27:11 2009

Subject: MEDIA REQUEST: EPA labeling of inert

ingredients

Hey everyone,

Hate bothering you on the holiday, but we got the

email below today and it’s on something I’m not familiar with – a pending EPA announcement on labeling

of inert ingredients.

We are asking about his

24a

timeline. . hope it can be deferred til Monday. But

in the event someone is waiting for a while family

runs a quick errand and can give me a bit of input, I’d

appreciate it.

Happy holidays and I hope none of us have to deal

with too many of these interruptions.

New phone number included below

Janice Person

Monsanto Public Affairs

Phone 901-320-5760

http://twitter.com/JPlovesCOTTON

From:

Sent:

To:

RICKETTS, MIMI [AG/1000]

Wednesday, December 23, 2009 6:12 PM

Greg Horstmeier; PERSON, JANICE L

[AG/1030]

Subject: RE: Need Commentary

Greg,

I am looping in my colleague Janice Person; she

handles media relations for our chemistry business.

What is your deadline? Sounds like it is quick.

Mimi

25a

From:

Greg Horstmeier

[mailto:Greg.Horstmeier@dtn.com]

Sent:

Wednesday, December 23, 2009 10:32 AM

To:

RICKETTS, MIMI [AG/1000]

Subject: Need Commentary

Importance: High

Mimi:

Hate to drop this on you, but I would like to get commentary on the announcement that EPA is planning

to require companies to display “inert” ingredients on

pesticide labels.

I know this has been a big issue with Monsanto over

the years, particularly as it relates to the various

Roundup formulations and the surfactants etc. in

each. I’m sure someone can discuss the issue of trade

secrets?

I am asking others as well, of course, but would

especially like to include you all.

THANKS!

Greg

Greg D. Horstmeier

Production Editor

Direct/Mobile: 402-707-0982

Omaha Office: 800-485-4000

greg.horstmeier@dtn.com

26a

Direct Mailing Address:

PO Box 31

Columbia, MO 65205

DTN/The Progressive Farmer – A Telvent Brand

9110 West Dodge Road, Suite 200

Omaha, NE 68114

www.dtnprogressivefarmer.com

27a

[Plaintiff ’s Trial

Exhibit

P-1340]

ATTENTION:

This specimen label is provided for

general information only.

• This pesticide product may not yet be available or

approved for sale or use in your area.

• It is your responsibility to follow all Federal, state

and local laws and regulations regarding the use of

pesticides.

• Before using any pesticide, be sure the intended use

is approved in your state or locality.

• Your state or locality may require additional precautions and instructions for use of this product

that are not included here.

• Monsanto does not guarantee the completeness or

accuracy of this specimen label. The information

found in this label may differ from the information

found on the product label. You must have the EPA

approved labeling with you at the time of use and

must read and follow all label directions.

• You should not base any use of a similar product on

the precautions, instructions for use or other information you find here.

• Always follow the precautions and instructions for

use on the label of the pesticide you are using.

28a

Spocialtylo;mul,t.d

Complete Directions for Use

Herbicide for Roundup Ready® Crops

Selective broad-spectrum weed control

in Roundup Ready® crops

Non-selective, broad-spectrum weed control for many

agricultural systems and farmsteads

Read the entire label before using this product. Use

only according to label directions.

AVOID CONTACT OF THIS HERBICIDE WITH

FOLIAGE, GREEN STEMS, EXPOSED NONWOODY ROOTS OR FRUIT OF CROPS, DESIRABLE PLANTS AND TREES, EXCEPT AS DIRECTED

FOR USE ON ROUNDUP READY® CROPS, AS

SEVERE PLANT INJURY OR DESTRUCTION

COULD RESULT.

THIS IS AN END-USE PRODUCT. MONSANTO

COMPANY DOES NOT INTEND AND HAS NOT

REGISTERED IT FOR REFORMULATION. SEE

INDIVIDUAL CONTAINER LABEL FOR REPACKAGING LIMITATIONS.

29a

Read the “LIMIT OF WARRANTY AND LIABILITY”

statement at the end of the label before buying or

using. If terms are not acceptable, return at once

unopened.

Not all products listed on this label are registered for

use in California. Check the registration status of

each product in California before using.

***

3.0 PRECAUTIONARY STATEMENTS

***

3.3 Physical or Chemical Hazards

Spray solutions of this product may be mixed, stored

and applied using stainless steel, fiberglass, plastic or

plastic-lined steel containers.

DO NOT MIX, STORE OR APPLY THIS PRODUCT

OR SPRAY SOLUTIONS OF THIS PRODUCT

IN GALVANIZED STEEL OR UNLINED STEEL

(EXCEPT STAINLESS STEEL) CONTAINERS OR

SPRAY TANKS. This product or spray solutions of

this product react with such containers and tanks to

produce hydrogen gas, which can form a highly

combustible gas mixture. This gas mixture could flash

or explode if ignited by open flame, spark, welder’s

torch, lighted cigarette or other ignition source and

cause serious personal injury.

DIRECTIONS FOR USE

It is a violation of Federal law to use this product

in any manner inconsistent with its labeling. This

product may only be used in accordance with the

Directions for Use on this label or in separately published supplemental labeling. Supplemental labeling

for this product can be obtained from your Authorized

30a

Monsanto Retailer or Monsanto Company Representative.

Do not apply this product in a way that will contact

workers or other persons, either directly or through

drift. Only protected handlers may be in the area

during application. For any requirements specific to

your State or Tribe, consult the agency responsible for

pesticide regulation.

Agricultural Use Requirements

Use this product only in accordance with its labeling

and with the Worker Protection Standard, 40 CFR

Part 170. This Standard contains requirements for

the protection of agricultural workers on farms,

forests, nurseries, and greenhouses, and handlers of

agricultural pesticides. It contains requirements for

training, decontamination, notification, and emergency

assistance. It also contains specific instructions

and exceptions pertaining to the statements on this

label about personal protective equipment (PPE) and

restricted-entry interval. The requirements in this

box only apply to uses of this product that are covered

by the Worker Protection Standard.

Do not enter or allow worker entry into treated areas

during the restricted-entry interval (REI) of 4 hours.

PPE required for early entry to treated areas that is

permitted under the Worker Protection Standard and

that involves contact with anything that has been

treated, such as plants, soil, or water, wean coveralls,

shoes plus socks and chemical-resistant gloves made

of any waterproof material.

Non-Agricultural Use Requirements

The requirements in this box apply to uses of this

product that are NOT within the scope of the Worker

31a

Protection Standard for agricultural pesticides (40

CFR Part 170). The WPS applies when this product

is used to produce agricultural plants on farms,

forests, nurseries or greenhouses.

Keep people and pets off treated areas until spray

solution has dried.

***

8.2 Aerial Application Equipment

Unless otherwise prohibited, all applications of this

product described on this label may be made using

aerial application equipment where appropriate,

provided that the applicator complies with the precautions and restrictions specified on this label or on

separate supplemental labeling published for this

product.

DO NOT APPLY THIS PRODUCT USING AERIAL

APPLICATION EQUIPMENT EXCEPT UNDER

CONDITIONS SPECIFIED ON THIS LABEL OR

ON SEPARATELY PUBLISHED SUPPLEMENTAL

LABELING FOR THIS PRODUCT.

FOR SPECIFIC USE INSTRUCTIONS, RESTRICTIONS

AND REQUIREMENTS RELATED TO THE AERIAL

APPLICATION OF THIS PRODUCT IN ARKANSAS

AND CALIFORNIA, OR SPECIFIC COUNTIES

THEREIN, REFER TO THE LIMITATIONS ON

AERIAL APPLICATION IN THAT STATE OR

COUNTY PRESENTED IN THIS SECTION.

Unless otherwise directed, the maximum single application rate of this product is 44 fluid ounces per acre

when using aerial application equipment. Apply this

product at the appropriate rate in 3 to 15 gallons of

water per acre unless otherwise directed on this label

or on separate supplemental labeling for this product.

32a

Refer to the individual use sections of this label for

application rates, spray volumes and additional directions for use.

Drift control reduction additives may be used.

Ensure uniform application. To avoid streaked,

uneven or overlapped application, use appropriate

marking devices.

Aircraft Maintenance

Thoroughly wash aircraft, especially landing gear,

after each day of spraying to remove residues of this

product accumulated during spraying or from spills.

PROLONGED EXPOSURE OF THIS PRODUCT TO

UNCOATED STEEL SURFACES COULD RESULT

IN CORROSION AND POSSIBLE FAILURE OF THE

PART. LANDING GEAR IS MOST SUSCEPTIBLE.

The maintenance of an organic coating (paint) that

meets aerospace specification MIL-C-38413 can help

prevent corrosion.

AERIAL SPRAY DRIFT MANAGEMENT

The following drift management requirements must

be followed to minimize off-target drift movement

during aerial application.

1. The distance of the outermost nozzles on the boom

must not exceed 3/4 the length of the wingspan or

rotor.

2. Nozzles must always point backward, parallel with

the air stream and never be pointed downwards more

than 45 degrees. Where states have more stringent

regulations, they must be followed.

Importance of Droplet Size

The most effective way to reduce drift potential is to

apply large droplets. The best drift management

33a

strategy is to apply the largest droplets that provide

sufficient coverage and control. Applying larger

droplets reduces drift potential, but will not prevent

drift if the application is made improperly, or under

unfavorable environmental conditions, such as in

windy, high temperature with law humidity, and/or

inversion conditions as described below.

Controlling Droplet Size

 Volume: Use high flow rate nozzles to apply the

highest practical spray volume. Nozzles with the

higher rated flows produce larger droplets.

 Pressure: Operate at a sprayer pressure towards

the lower end of the range listed for the nozzle.

Higher pressure reduces droplet size and does not

improve canopy penetration. When higher flow

rates are needed, use higher flow rate nozzles

instead of increasing the pressure.

 Number of nozzles: Use the minimum number of

nozzles that provide uniform coverage.

 Nozzle orientation: Orienting nozzles so that the

spray is released backwards, parallel to the air

stream, will produce larger droplets than other

orientations. Significant deflection from the horizontal will reduce droplet size and increase drift

potential.

 Nozzle type: Use a nozzle type that is designed for

the intended application. With most nozzle types,

narrower spray angles produce larger droplets.

Consider using low-drift nozzles. Solid stream

nozzles oriented straight back produce larger droplets than other nozzle types.

 Boom length: For some use patterns, reducing

the effective boom length to less than 3/4 of the

34a

wingspan or rotor length could further reduce drift

without reducing swath width.

 Application height: Application must be made at a

height of 10 feet or less above the top of the largest

plants unless a greater height is required for

aircraft safety. Making the application at the

lowest height that is safe reduces the exposure of

the droplets to evaporation and wind.

Swath Adjustment

When an application is made with a crosswind

present, the swath will be displaced downwind.

Therefore, on the upwind and downwind edges of

the field, the applicator must compensate for this

displacement by adjusting the path of the aircraft

upwind. Increase the swath adjustment distance with

increasing drift potential (higher wind, smaller droplets, etc.).

Wind

Drift potential is lowest at wind speeds of between 2

and 10 miles per hour. However, many factors, including droplet size and equipment type, determine drift

potential at any given wind speed. Avoid application

when wind speeds are below 2 miles per hour due to

variable wind direction and high inversion potential.

NOTE: Local terrain can influence wind patterns.

Every applicator must be familiar with local wind

patterns and how they affect drift.

Temperature and Humidity

When making an application in low relative humidity,

set application equipment to produce larger droplets

to compensate for evaporation. Droplet evaporation is

most severe when conditions are both hot and dry.

35a

Temperature Inversion

Do not apply this product during a temperature inversion as drift potential is high under these conditions.

Temperature inversions restrict vertical air mixing,

which causes small droplets to remain suspended in a

concentrated cloud. This cloud can move in unpredictable directions due to the light variable winds common

during inversions. Temperature inversions are characterized by increasing temperatures with altitude

and are common on nights with limited cloud cover

and light to no wind. They begin to form as the

sun sets and often continue into the morning. Their

presence can be indicated by ground fog; however, if

fog is not present, inversions can also be identified

by the movement of smoke from a ground source or

an aircraft smoke generator. Smoke that layers and

moves laterally in a concentrated cloud (under low

wind conditions) indicates an inversion, while smoke

that moves upward and rapidly dissipates indicates

good vertical air mixing.

Sensitive Areas

Apply this product only when the potential for drift to

adjacent sensitive areas (e.g., residential areas, bodies

of water, known habitat for threatened or endangered

species, non-target crops) is minimal (e.g., when wind

is blowing away from the sensitive areas).

Avoid direct application to any body of water.

State Specific Limitations on Aerial Application

LIMITATIONS ON AERIAL APPLICATION

IN CALIFORNIA ONLY

DO NOT apply this product using aerial application

equipment in residential areas.

36a

AVOID DRIFT — DO NOT APPLY WHEN WINDS

ARE GUSTY OR UNDER ANY OTHER CONDITION

THAT FAVORS DRIFT. DRIFT OF THIS PRODUCT

ONTO ANY VEGETATION TO WHICH APPLICATION WAS NOT INTENDED CAN CAUSE

DAMAGE. TO PREVENT INJURY TO ADJACENT

DESIRABLE VEGETATION, USE PROPER AERIAL

APPLICATION EQUIPMENT FITTED WITH

APPROPRIATE

NOZZLES

AND

MAINTAIN

ADEQUATE BUFFERS. Follow the directions below

when making an aerial application near non-target

crops, desirable annual vegetation, or desirable perennial vegetation after bud break and before total leaf

drop.

1. Do not apply this product within 100 feet of all

desirable vegetation or non-target crops.

2. If winds are blowing up to 5 miles per hour

TOWARD desirable vegetation or non-target crops, do

not apply this product within 500 feet of the desirable

vegetation or crops.

3. If winds are blowing between 5 and 10 miles per

hour TOWARD desirable vegetation or non-target

crops, a buffer zone greater than 500 feet might be

needed to protect the desirable vegetation or crops.

4. Do not apply this product using aerial application

equipment when winds are blowing in excess of 10

miles per hour.

5. Do not apply this product using aerial application

equipment when inversion conditions exist. When

tank-mixing this product with 2,4-D, only 2,4-D amine

formulations may be applied in California using aerial

application equipment. Tank mixtures of this product

with 2,4-D amine formulations may be applied by air

in California in fallow fields and in reduced tillage

37a

systems, and for alfalfa and pasture renovation applications only.

This product, when tank-mixed with dicamba, may

not be applied by air in California.

ADDITIONAL LIMITATIONS FOR AERIAL

APPLICATION IN FRESNO COUNTY,

CALIFORNIA ONLY

Always read and follow the label directions and

precautionary statements for all products used in the

aerial application.

The following information applies only from February

15 through March 31 within the following boundaries

of Fresno County, California:

North: Fresno County line

South: Fresno County line

East: State Highway 99

West: Fresno County line

Observe the following directions to minimize off-site

movement during aerial application of this product. Minimization of off-site movement is the responsibility of the grower, Pest Control Advisor and aerial

applicator.

Written Directions

Written directions MUST be submitted by or on behalf

of the applicator to the Fresno County Agricultural

Commissioner 24 hours prior to the application.

These written directions MUST state the proximity

of surrounding crops and that conditions of each

manufacturer’s product label and this label have been

satisfied.

38a

Aerial Applicator Training and Equipment

Aerial application of this product is limited to pilots

who have successfully completed a Fresno County

Agricultural Commissioner and California Department of Pesticide Regulation approved training program for aerial application of herbicides. All aircraft

must be inspected, critiqued in flight and certified at

a Fresno County Agricultural Commissioner approved

fly-in. Test and calibrate spray equipment at intervals

sufficient to insure that proper rates of herbicides

and adjuvants are being applied during commercial

use. Applicator must document such calibrations and

testing. Demonstration of performance at Fresno

County Agricultural Commissioner approved fly-ins

constitutes such documentation, or other written

records showing calculations and measurements of

tight and spray parameters acceptable to the Fresno

County Agricultural Commissioner.

Application at Night — Do not apply this product

by air earlier than 30 minutes prior to sunrise and/or

later than 30 minutes after sunset without prior

permission from the Fresno County Agricultural

Commissioner.

To report known or suspected misuse of this product,

call 1-800-332-3111.

For additional information on the proper aerial

application of this product in Fresno County, call

1-800-332-3111.

LIMITATIONS ON AERIAL APPLICATION IN

ARKANSAS ONLY

AVOID DRIFT. DO NOT APPLY INTO STILL AIR

WHERE THERE IS A TEMPERATURE INVERSION

39a

LAYER LOW ENOUGH FOR FINE SPRAY PARTICLES TO BECOME SUSPENDED AND MOVE OUTSIDE THE TARGET AREA WHEN THE INVERSION

LAYER MOVES. DO NOT APPLY WHEN WINDS

ARE GUSTY OR UNDER ANY OTHER CONDITION

THAT FAVORS DRIFT. DRIFT IS LIKELY TO CAUSE

DAMAGE TO ANY VEGETATION CONTACTED.

TO PREVENT INJURY TO ADJACENT DESIRABLE

VEGETATION, APPROPRIATE BUFFER ZONES

MUST BE MAINTAINED.

Apply this product at the appropriate rate in 3 to 15

gallons of water per acre.

Use sufficient carrier volume and appropriate equipment set-up to form droplets large enough to avoid

drift potential. Coarse droplets in the 300 to 500

(VMD) micron range have a lower drift potential.

Applications are typically to be made with the nozzle

release point at 8 to 15 feet above the top of the target

plants unless a greater height is required for aircraft

safety.

The distance of the outermost nozzles on the boom

must not exceed 75 percent of the length of the wingspan or rotor. In many cases, reducing this distance

to 65 percent of the length of the wingspan or rotor

will improve drift control without affecting the swath

width.

Nozzles must always discharge backward parallel

with the air stream and never discharge downwards

more than 45 degrees on fixed wing aircraft or forward

of the prevailing airflow on rotary winged aircraft.

Avoid the use of nozzles with wide-angle discharge.

Do not apply this product when winds are in excess of

10 miles per hour.

40a

Do not apply when there is a low-level inversion where

fine spray particles could be suspended in still air and

move outside the target area when the inversion layer

moves. These conditions can occur when wind speeds

are less than 2 miles per hour.

Follow the directions below when an aerial application

is made near non-target crops or other desirable vegetation:

1. Do not apply this product within 100 feet of nontarget crops or any desirable vegetation.

2. If winds are blowing up to 5 miles per hour

TOWARD non-target crops or desirable vegetation, do

not apply this product within 500 feet upwind of the

desirable vegetation or crop.

3. If winds are blowing between 5 and 10 miles per

hour TOWARD non-target crops or desirable vegetation, a buffer zone greater than 500 feet might be

needed to protect the crop or desirable vegetation.

***

9.9 Sugarcane

TYPES OF APPLICATION: Those listed in Section

9.0, plus Spot Treatment

Preplant, At-Planting, Preemergence

USE INSTRUCTIONS: This product may be applied

in or around sugarcane fields, or in fields prior to the

emergence of plant cane.

RESTRICTIONS: Do not apply to vegetation in or

around ditches, canals or ponds containing water to be

used for irrigation.

Spot Treatment

USE INSTRUCTIONS: This product may be applied

as a spot treatment in sugarcane. For control of

41a

volunteer or diseased sugarcane, apply a 1-percent

solution of this product in water using a handheld

sprayer and a spray-to-wet technique. Enhanced

results can be obtained on volunteer or diseased

sugarcane when application is made when there are

at least 7 new leaves. Avoid contact of this herbicide

with healthy sugarcane plants as severe damage or

destruction could result.

RESTRICTIONS: Do not feed or graze sugarcane

foliage within the application area.

Hooded Sprayer

USE INSTRUCTIONS: This product may be applied

using a hooded sprayer for weed control in between

rows of sugarcane. See additional instructions on

the use of hooded sprayers in the “APPLICATION

EQUIPMENT AND TECHNIQUES” section of this

label.

PRECAUTIONS: Do not allow weeds within the

application area to come into contact with the crop.

Fallow Treatment

USE INSTRUCTIONS: This product may be used as

a replacement for tillage in fields that are lying fallow

between sugarcane crops. This product may also be

used to remove the last stubble of ratoon cane by

applying 2.5 to 3.3 quarts of this product in 10 to 40

gallons of water per acre to new growth having at least

7 new leaves. Allow a minimum of 7 days after application before tillage. Aerial application of up to 64

fluid ounces per acre may be made onto fallow sites

where there is sufficient buffer to prevent drift onto

adjacent crops. Tank mixtures with 2,4-D or dicamba

may be used. Ensure that the product used is labeled

for this application in sugarcane. Read and follow

label directions for all products in the tank mixture.

42a

9.9.1 Sugarcane Ripening

USE INSTRUCTIONS: This product may be used

as a foliar-applied plant growth regulator to hasten

ripening and extend the period of high sucrose level

in both low- and high-tonnage sugarcane. Most of the

sucrose increase is concentrated in the top nodes of the

cane stalk. To maximize sugar recovery where topping

is practiced at harvest, top at the base of the fourth

leaf. Consult your state sugarcane authority or local

Monsanto Company representative regarding the

degree of sucrose response that can be anticipated

prior to application of this product.

As a result of leaf desiccation, improved trash burn

can be expected.

Apply this product at the following rates and timing

according to the State in which the sugarcane is

grown. Use the higher application rate within the

given range when applying to sugarcane under

adverse ripening conditions or to less responsive

varieties.

FLORIDA — Apply 5 to 12 fluid ounces of this

product per acre 3 to 5 weeks before harvest of LAST

RATOON CANE ONLY.

HAWAII — Apply 9 to 21 fluid ounces of this product

per acre 4 to 10 weeks before harvest.

LOUISIANA — Apply 4 to 12 fluid ounces of this

product per acre 3 to 7 weeks before harvest of

RATOON CANE ONLY.

PUERTO RICO — Apply 5 fluid ounces of this product per acre 3 to 5 weeks before harvest of RATOON

CANE ONLY.

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TEXAS — Apply 5 to 12 fluid ounces of this product

per acre 3 to 5 weeks before harvest of RATOON

CANE ONLY.

PRECAUTIONS: Application of this product could

initiate development of shooting eyes. This product

might not increase the sucrose content of sugarcane

under conditions of good natural ripening. Within 2

to 3 weeks after application, this product could produce a slight yellowing to a pronounced browning and

drying of leaves and a shortening of upper internodes.

Spindle death could occur.

Rainfall within 6 hours after application could reduce

the effectiveness of this product.

Application to sugarcane grown for seed could result

in a reduction in germination or vigor. To the extent

consistent with applicable law, buyer and all users

are responsible for any and all loss or damage in

connection with the preharvest use of this product on

sugarcane grown for seed.

RESTRICTIONS: On not feed or graze sugarcane

forage following application. Do not plant subsequent

crops within 30 days after application of this product

other than the following: alfalfa or other forage legumes, beans (all types), corn (all types), cotton, melons

(all types), pasture grasses, peanuts, potatoes (Irish or

sweet), sorghum (milo), soybeans, squash (all types) or

wheat.

Do not apply for enhanced ripening to any crops other

than sugarcane. Use of this product in any manner

not consistent with this label could result in injury to

persons, animals or crops, or have other unintended

consequences.

***

44a

[Plaintiff ’s Trial

Exhibit

P-2582]

Message

From:

Sent:

To:

CC:

ADAMS, STEPHEN A [AG/1000]

[/O=MONSANTO/OU=NA-1000-01/

CN=RECIPIENTS/CN=113797]

12/14/2010 6:07:35 PM

KLOPF, GARY J [AG/1000] [/O=MONSANTO/ OU=NA-1000-01/CN=RECIPIENTS/ CN=162545]

HEMMINGHAUS, JOHN W [AG/1000]

[/O=MONSANTO/OU=NA-1000-01/

CN=RECIPIENTS/CN=521714];

DYSZLEWSKI, ANDREW D [AG/1000]

[/0=MONSANTO/OU=NA-1000-01/

CN=RECIPIENTS/CN=102676]; LASARTE,

MARTIN A [AG/5001] [/0=MONSANTO/

OU=NA-1000-01/CN=RECIPIENTS/

CN=22015]; KAVANAS, DIEGO [AG/5001]

[/O=MONSANTO/OU=LA-5001-01/

CN=RECIPIENTS/CN=191954]; GUIBERT,

MELISA [AG/5000] [/O=MONSANTO/

OU=LA-5000-01/CN=RECIPIENTS/

CN=661675]; WATSON, GREGORY R

[AG/1000] [/O=MONSANTO/OU=NA-100001/CN=RECIPIENTS/CN=GRWATS];

HEYDENS, WILLIAM F [AG/1000]

[/O=MONSANTO/OU=NA-1000-01/

CN=RECIPIENTS/CN=230737]; FARMER,

DONNA R [AG/1000] [/O=MONSANTO/

OU=NA-1000-01/CN=RECIPIENTS/

45a

CN=180070]; SALTMIRAS, DAVID A

[AG/1000] [/O=MONSANTO/OU=NA-100001/CN=RECIPIENTS/CN=DASALT];

MORRISON, BRINNON L [AG/1000]

[/O=MONSANTO/OU=NA-1000-01/

CN=RECIPIENTS/CN=BLMORR1]

Subject: Re: Response Need – Re: Glyphosate

Questions (Argentina); FW: publicaciones

CASAFE en la pagina

All:

We have information and data to address most all of

this. There are basically 2 parts that I see – 1) the

chronic toxicity of glyphosate and its impurities

and metabolites, and 2) the toxicity of the POEA

surfactants.

With regards to the carcinogenicity of our formulations we don’t have such testing on them directly but

we do have such testing on the glyphosate component

and some extensive tox testing on the surfactant.

Since the glyphosate formulations are simply a blend

of these components, I think we can address these

questions in a confident manner. The biggest factor

is time. With the approaching holiday season it may

be several weeks before we can have the detailed

response which this deserves prepared.

I have copied in the Tech Center people who would

need to be involved in preparing the response and

invite there comment. I will also follow-up with them.

Steve

46a

From:

To:

Cc:

KLOPF, GARY J [AG/1000]

ADAMS, STEPHEN A [AG/1000]

HEMMINGHAUS, JOHN W [AG/1000];

DYSZLEWSKI, ANDREW D [AG/1000];

LASARTE, MARTIN A [AG/5001];

KAVANAS, DIEGO [AG/5001]; GUIBERT,

MELISA [AG/5000]

Sent:

Tue Dec 14 08:28:57 2010

Subject: Response Need – Re: Glyphosate Questions

(Argentina); FW: publicaciones CASAFE en

la pagina

Steve,

Could you and/or someone else in the Regulatory

group respond to the questions Martin has raised?

Thanks,

Gary

From: HEMMINGHAUS, JOHN W [AG/1000]

Sent:

Monday December 13, 2010 4:58 PM

To:

KLOPF, GARY J [AG/1000]

Cc:

DYSZLEWSKI, ANDREW D [AG/1000]

Subject: FW: publicaciones CASAFE en la pagina

47a

From:

Sent:

To:

LASARTE, MARTIN A [AG/5001]

Monday December 13, 2010 3:37 PM

HEMMINGHAUS, JOHN W [AG/1000];

DYSZLEWSKI, ANDREW D [AG/1000]

Cc:

KAVANAS, DIEGO [AG/5001]; GUIBERT,

MELISA [AG/5000]

Subject: FW: publicaciones CASAFE en la pagina

John, Andy:

Please can you contact me with the right person to

answer the bellow question regarding glysophate

formulations metabolites and potential carcinogenic

properties? We also would need some comprehensive

information about POEAs surfactants.

The request is to assist us regarding some discussions

talking place with some Universities and we don’t

have that kind of knowledge within the region.

Specifically we would need to understand:

1) Why Roundup formulations are not carcinogenic?

What are their most relevant metabolites and

what study showed they are not?

2) NNG and formaldehyde are the 2 impurities with

known carcinogenic properties that we follow very

closely with FAQ standards. Are they also present

on the metabolites?

3) I know from the process stand point that the

AMPA is also a impurity we have under control.

Is AMPA also a metabolite? Is it carcinogenic?

48a

4) POEAs surfacant definition and classification.

Why are they questioned?

It would be very comprehensive if there is a table

showing the metabolites, their concentration on a

regular basis, they carcinogenic properties and the

limits

Thank you! Martin

***

49a

[insert P-3047 foldout]

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.