Petition for Writ of Certiorari — Monsanto Company, Petitioner v. John L. Durnell

Supreme Court briefApr 4, 2025

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No. ______

In the

Supreme Court of the United States

________________

MONSANTO COMPANY,

Petitioner,

JOHN L. DURNELL,

Respondent.

________________

On Petition for Writ of Certiorari to the

Missouri Court of Appeals

________________

PETITION FOR WRIT OF CERTIORARI

________________

DAVID M. ZIONTS

MICHAEL X. IMBROSCIO

COVINGTON &

BURLING LLP

One CityCenter

850 Tenth Street NW

Washington, DC 2001

(202) 662-6000

PAUL D. CLEMENT

Counsel of Record

MATTHEW D. ROWEN

JAMES Y. XI

NICCOLO A. BELTRAMO*

CLEMENT & MURPHY, PLLC

706 Duke Street

Alexandria, VA 22314

(202) 742-8900

paul.clement@clementmurphy.com

K. LEE MARSHALL

BRYAN CAVE

LEIGHTON PAISNER *Supervised by principals of the

Three Embarcadero

firm who are members of the

Center

Virginia bar

San Francisco, CA 94111

April 4, 2025

Counsel for Petitioner

QUESTION PRESENTED

The Federal Insecticide, Fungicide, and

Rodenticide Act (“FIFRA”) creates a comprehensive

regulatory scheme governing the use, sale, and

labeling of pesticides. The Act preempts any state

“requirement[] for labeling or packaging in addition to

or different from those required under” FIFRA. 7

U.S.C. §136v(b). For decades, EPA has exercised its

authority under FIFRA to find that Monsanto’s

Roundup product line and its active ingredient,

glyphosate, do not cause cancer in humans.

Consistent with that understanding, EPA has

repeatedly approved Roundup’s label without a cancer

warning. FIFRA prohibits Monsanto from making

any substantive change to an EPA-approved label

unless it first obtains EPA’s permission.

Respondent is one of more than 100,000 plaintiffs

across the country that nonetheless seek to hold

Monsanto liable for not warning users that

glyphosate, the active ingredient in Roundup, causes

cancer. The federal courts of appeals and state

appellate courts are divided over whether FIFRA

preempts such claims. The Third Circuit has held that

it does. In the decision below, the Missouri Court of

Appeals joined the Ninth and Eleventh Circuits and

state appellate courts in California and Oregon in

holding that it does not.

The question presented is:

Whether FIFRA preempts a state-law failure-towarn claim where EPA has repeatedly concluded that

the warning is not required and the warning cannot

be added to a product without EPA approval.

PARTIES TO THE PROCEEDING

Petitioner Monsanto Company was the appellant

in the Missouri Court of Appeals. Respondent John L.

Durnell was the appellee.

iii

CORPORATE DISCLOSURE STATEMENT

Petitioner Monsanto Company is an indirect,

wholly owned subsidiary of Bayer AG, a publicly held

corporation. No other publicly held corporation owns

10% or more of Monsanto’s stock.

STATEMENT OF RELATED PROCEEDINGS

Durnell v. Monsanto Co., No. SC100975 (Mo.)

(application for transfer denied Apr. 1, 2025).

Durnell v. Monsanto Co., No. ED 112410 (Mo. Ct.

App.) (opinion and judgment issued Feb. 11, 2025).

Durnell v. Monsanto Co., No. 1922-CC00221 (Mo.

Cir. Ct. of the City of St. Louis) (judgment entered

Jun. 24, 2024).

TABLE OF CONTENTS

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

PARTIES TO THE PROCEEDING ........................... ii

CORPORATE DISCLOSURE STATEMENT ........... iii

STATEMENT OF RELATED PROCEEDINGS ....... iv

TABLE OF AUTHORITIES ..................................viiiii

PETITION FOR WRIT OF CERTIORARI ................ 1

OPINIONS BELOW ................................................... 3

JURISDICTION ......................................................... 4

STATUTORY PROVISIONS INVOLVED ................. 4

STATEMENT OF THE CASE ................................... 4

A. Legal Background ........................................ 4

B. Factual Background ..................................... 7

C. Procedural History ..................................... 12

REASONS FOR GRANTING THE PETITION....... 16

The Decision Below Deepens A Square And

Acknowledged Circuit Split .............................. 17

II. The Decision Below Is Wrong ........................... 23

III. The Question Presented Is Important, And

This Case Is An Ideal Vehicle To Resolve It .... 32

CONCLUSION ......................................................... 37

APPENDIX

Appendix A

Order, Supreme Court of Missouri,

Durnell v. Monsanto Co., No. SC100975

(Apr. 1, 2025) ............................................... App-1

Appendix B

Opinion, Missouri Court of Appeals,

Durnell v. Monsanto Co., No. ED112410

(Feb. 11, 2025) ............................................. App-2

Appendix C

Order, Missouri Circuit Court, TwentySecond

Judicial

Circuit,

Durnell

v. Monsanto Co., No. 1922-CC00221

(Sept. 28, 2023) .......................................... App-13

Appendix D

Order, Missouri Circuit Court, TwentySecond

Judicial

Circuit,

Durnell

v. Monsanto Co., No. 1922-CC00221

(Oct. 17, 2023) ............................................ App-17

Appendix E

Order, Missouri Circuit Court, TwentySecond

Judicial

Circuit,

Durnell

v. Monsanto Co., No. 1922-CC00221

(Oct. 19, 2023) ............................................ App-18

Appendix F

Order and Judgment, Missouri Circuit

Court, Twenty-Second Judicial Circuit,

Durnell v. Monsanto Co., No. 1922CC00221 (Jan. 19, 2024) ........................... App-19

Appendix G

Judgment, Missouri Circuit Court,

Twenty-Second Judicial Circuit, Durnell

v. Monsanto Co., No. 1922-CC00221

(June 24, 2024) .......................................... App-20

vii

Appendix H

United States Environmental Protection

Agency Memorandum re: Withdrawal of

the Glyphosate Interim Registration

Review Decision (Sept. 21, 2022) .............. App-22

Appendix I

Letter

From

United

States

Environmental

Protection

Agency

Re: Glyphosate (Aug. 7, 2019) ................... App-38

Appendix J

Letter from United States Environmental

Protection Agency to Lauren Zeise, Office

Environmental

Health

Hazard

Assessment, California Environmental

Protection Agency (Apr. 8, 2022) .............. App-41

Appendix K

Relevant Statutory Provision.................... App-44

7 U.S.C. §136v(a)-(b) ........................... App-44

viii

TABLE OF AUTHORITIES

Cases

Bates v. Dow Agrosciences LLC,

544 U.S. 431 (2005) .................. 5, 7, 23-27, 33-34, 36

Carson v. Monsanto Co.,

92 F.4th 980 (11th Cir. 2024) .......... 2, 15, 19, 20, 21

Fischer v. Johns-Manville Corp.,

512 A.2d 466 (N.J. 1986) ....................................... 33

Gomez-Perez v. Potter,

553 U.S. 474 (2008) ................................................ 35

Hardeman v. Monsanto Co.,

997 F.3d 941 (9th Cir. 2021)......... 2, 8, 15, 18-21, 24

Home Ins. Co. v. Am. Home Prods. Corp.,

550 N.E.2d 930 (N.Y. 1990) ................................... 33

In re Roundup Prods. Liab. Litig.,

214 F.Supp.3d 1346 (J.P.M.L. 2016) ..................... 12

In re Roundup Prods. Liab. Litig.,

390 F.Supp.3d 1102 (N.D. Cal. 2018)...................... 9

Johnson v. Monsanto Co.,

554 P.3d 290 (Or. App. 2024) ............................ 2, 19

MacDonald v. Monsanto Co.,

27 F.3d 1021 (5th Cir. 1994).................................. 28

McMullen v. Medtronic, Inc.,

421 F.3d 482 (7th Cir. 2005).................................. 36

Medtronic, Inc. v. Lohr,

518 U.S. 470 (1996) ................................................ 36

Merck Sharp & Dohme Corp. v. Albrecht,

587 U.S. 299 (2019) ................................................ 31

Mut. Pharm. Co. v. Bartlett,

570 U.S. 472 (2013) ................................................ 28

Nat. Res. Def. Council

v. U.S. Env’t Prot. Agency,

38 F.4th 34 (9th Cir. 2022) .................................... 11

Nat’l Ass’n of Wheat Growers v. Bonta,

85 F.4th 1263 (9th Cir. 2023) ................................ 10

Pilliod v. Monsanto Co.,

282 Cal.Rptr.3d 679 (Ct. App. 2021) ................. 2, 19

PLIVA, Inc. v. Mensing,

564 U.S. 604 (2011) .................................... 15, 28, 29

Reckitt Benckiser, Inc. v. Jackson,

762 F.Supp.2d 34 (D.D.C. 2011) ............................ 28

Riegel v. Medtronic, Inc.,

552 U.S. 312 (2008) .................................... 25, 26, 35

Ruckelshaus v. Monsanto Co.,

467 U.S. 986 (1984) .................................................. 4

Schaffner v. Monsanto Corp.,

113 F.4th 364 (3d Cir. 2024)...... 1, 2, 7, 20-22, 24-28

Thornton v. Tyson Foods, Inc.,

28 F.4th 1016 (10th Cir. 2022) .............................. 36

Turek v. Gen. Mills, Inc.,

662 F.3d 423 (7th Cir. 2011).................................. 34

Wis. Pub. Intervenor v. Mortier,

501 U.S. 597 (1991) .............................................. 4, 6

Statutes

7 U.S.C. §136 .............................................................. 5

7 U.S.C. §136a ...................... 4, 5, 6, 18, 19, 28, 29, 31

7 U.S.C. §136j ....................................................... 6, 29

7 U.S.C. §136k ............................................................ 5

7 U.S.C. §136l ............................................................. 5

7 U.S.C. §136v ............................ 1, 6, 7, 14, 23, 34, 35

21 U.S.C. §355 .......................................................... 31

21 U.S.C. §360k .................................................. 25, 35

21 U.S.C. §467e......................................................... 35

21 U.S.C. §678 .......................................................... 35

49 U.S.C. §30103 ...................................................... 35

Mont. Rev. Codes Ann. §27-213 (1971) .................... 34

N.C. Gen. Stat. §143-434–70 (1971) ........................ 34

N.H. Rev. Stat. §149-D (1972) .................................. 34

Regulations

40 C.F.R. §152.40 ........................................................ 5

40 C.F.R. §152.44............................................ 6, 20, 29

40 C.F.R. §152.46........................................................ 6

40 C.F.R. §152.50...................................................... 29

40 C.F.R. §152.112 ...................................................... 5

40 C.F.R. §155.58.................................................. 6, 32

40 C.F.R. §156.10........................................................ 5

40 C.F.R. §156.60........................................................ 5

40 C.F.R. §156.70.................................................. 6, 29

40 C.F.R. §158.500 ...................................................... 5

Other Authorities

B. Hurst, Roundup Lawsuits Pose a Threat to

My Missouri Farm, Wall Street Journal

(Sept. 13, 2024), https://perma.cc/M24FTJTB ....................................................................... 13

D. Cameron & P. Thomas, Bayer Told to Pay

$1.56 Billion After Losing Roundup Case,

Wall Street Journal (Nov. 18, 2023),

https://perma.cc/MZP4-HANE .............................. 33

En Banc Pet., Schaffner v. Monsanto Corp.,

No. 22-3075 (3d Cir. filed Sept. 12, 2024) ............. 22

EPA, Chemical Name: Glyphosate,

https://perma.cc/7PHA-8UXP ................................ 12

EPA, Glyphosate Proposed Interim

Registration Review Decision (Apr. 2019),

https://perma.cc/8K63-HD36 ................................. 10

EPA, Office of Pesticide Programs, Pesticide

Registration Notice 2000-5 (May 10, 2000),

https://perma.cc/ANB4-UGG9 ..................... 6, 29, 30

EPA, Office of Pesticide Programs, Pesticide

Registration Notice 98-10 (Oct. 22, 1998),

https://perma.cc/EZ7M-62MY ........................... 6, 30

EPA, Office of Pesticides and Toxic

Substances, Guidance for the Reregistration

of Pesticide Products Containing

Glyphosate as the Active Ingredient (June

1986), https://perma.cc/DTH7-FR4V ....................... 8

EPA, Pesticide Registration Manual (last

updated April 2017),

https://perma.cc/3GTB-3892 .................................... 6

EPA, Reregistration Eligibility Decision

(RED) Glyphosate (Sept. 1993),

https://perma.cc/528H-F4FN ............................. 8, 32

EPA, Revised Glyphosate Issue Paper:

Evaluation of Carcinogenic Potential (Dec.

12, 2017), https://perma.cc/UWM2-6BHB .......... 8, 9

xii

EPA.Br., NRDC v. EPA, Nos. 20-70787,

20-70801 (9th Cir. May 18, 2021).......................... 11

Glyphosate; Pesticide Tolerances,

73 Fed. Reg. 73,586 (Dec. 3, 2008) .......................... 8

H. Smolak, Bayer Shares Fall After Jury

Orders $2.25 Billion in Damages in

Roundup Case, Wall Street Journal (Jan.

29, 2024), https://perma.cc/7ZMD-75JH ............... 33

IARC, 112 Some Organophosphate

Insecticides and Herbicides (2015),

https://perma.cc/9TPL-278R .................................... 9

Mem. of Decision and Order on Defs.’ Mot.

for Summ. J., Dkt. 40, Cardillo v. Monsanto

Co., No. 2177CV00462 (Mass. Super. Ct.

filed Oct. 21, 2024) ................................................. 22

Memorandum from Cathryn Britton, Branch

Chief, Risk Management and

Implementation Branch V, Pesticide Reevaluation Division, to Glyphosate

Registration Review Docket (EPA-HQOPP-2009-0361) (Sept. 21, 2022),

https://perma.cc/3KDJ-JT2N ................................. 11

Order Granting Def.’s Mot. for Partial

Summ. J., Dkt. 1058, Peters v. Monsanto

Co., No. 1CCV-20-0001630 (Haw. Cir. Ct.

filed Oct. 25, 2023) ................................................. 22

P. Cohen, Roundup Weedkiller Is Blamed for

Cancers, but Farmers Say It’s Not Going

Away, N.Y. Times (Sept. 20, 2019),

https://perma.cc/J2LQ-BEKS ................................ 13

xiii

T. Joyce, Am. Tort Reform Ass’n, When

Plaintiffs’ Attorneys Mislead the Public,

Bloomberg Law (Sept. 28, 2022),

https://perma.cc/SV28-9BFW ................................ 12

U.S. Br., Monsanto Co. v. Hardeman,

No. 19-16636 (9th Cir. filed Dec. 20, 2019) ........... 12

U.S. Br., Monsanto Co. v. Hardeman,

No. 21-241 (U.S. filed May 10, 2022) ...................... 3

PETITION FOR WRIT OF CERTIORARI

The Federal Insecticide, Fungicide, and

Rodenticide Act (“FIFRA”) includes a “[u]niformity”

provision that expressly preempts all state

“requirements for labeling or packaging” that are “in

addition to or different from those required under”

FIFRA. 7 U.S.C. §136v(b). There is a square and

acknowledged circuit split over the scope of that

provision as applied to the particular product at issue

here.

Specifically, in evaluating suits against

Petitioner for its Roundup product (of which there are

many), the circuits have split over “whether, once the

Environmental Protection Agency (‘EPA’) registers

and approves a pesticide label that omits a particular

health warning, a state-law duty to include that

warning is preempted.” Schaffner v. Monsanto Corp.,

113 F.4th 364, 370-71 (3d Cir. 2024).

The Third Circuit says yes. In a thorough, 65page opinion, a unanimous panel of that court held

that FIFRA preempted a state-law failure-to-warn

claim that sought to hold Monsanto liable for failing to

warn users of the alleged carcinogenic effects of

glyphosate, the active ingredient in Monsanto’s

Roundup product. The Third Circuit explained that

EPA “regulations promulgated to implement FIFRA

require the health warnings on a pesticide’s label to

conform to the proposed label approved by the EPA

during the registration process.” Id. at 371. Thus,

when EPA has conducted “extensive review of [the]

scientific evidence” of a potential health issue (as it

had with glyphosate) and “approved proposed labels

omitting a [health] warning” on that issue, FIFRA

preempts a “state-law duty to include” that same

warning. Id

As the Third Circuit recognized, however, its

“analysis differs from” that of its “colleagues in other

courts.” Id. at 399. Like the Missouri Court of Appeals

here, the Ninth and Eleventh Circuits (as well as

intermediate appellate courts in California and

Oregon) have held that FIFRA does not preempt statelaw failure-to-warn claims that seek to hold Monsanto

liable for not warning users of the alleged carcinogenic

effects of glyphosate. According to those courts,

FIFRA does not preempt state-law claims so long as

the elements of the claim can be said to “parallel”

FIFRA’s general misbranding prohibition. See Carson

v. Monsanto Co., 92 F.4th 980 (11th Cir. 2024);

Hardeman v. Monsanto Co., 997 F.3d 941 (9th Cir.

2021); Johnson v. Monsanto Co., 554 P.3d 290 (Or.

App. 2024), appeal denied, 562 P.3d 237 (Or. 2024);

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

2021), appeal denied, No. S270957 (Cal. Nov. 17,

2021). It is immaterial in those courts that EPA has

repeatedly “approv[ed] … individual pesticide

registrations and corresponding labels” without the

relevant warning, or that “manufacturers cannot

change the label’s contents without the Agency’s prior

approval.” Carson, 92 F.4th at 990, 992.

The Court should resolve this split now. The legal

issues have been exhaustively ventilated and explored

from every angle in lengthy opinions from multiple

federal and state appellate courts. There is no

material chance the split will resolve itself, as the

Third and Eleventh Circuits have each denied en banc

review.

And as this case exemplifies, the

consequences are enormous. More than 100,000 cases

have been filed seeking to hold Monsanto liable based

on a supposed link to cancer that the EPA has

exhaustively studied and rejected as unfounded. The

litigation has already forced Monsanto to remove

glyphosate from its consumer version of Roundup, but

the continuing overhang of these lawsuits threatens

Monsanto’s ability to continue to supply glyphosate to

farmers who need it to remain world leaders in food

production.

More broadly, without this Court’s

intervention, the circuit conflict will engender

confusion in litigation over any pesticide whose safety

EPA has reviewed and whose label it has approved.

And it will breed uncertainty in the interpretation of

myriad other similarly worded preemption provisions.

This Court previously recognized the importance

of the question presented when it called for the views

of the Solicitor General in Hardeman, No. 21-241. In

response, the United States recommended that this

Court not “grant review unless and until a conflict in

authority emerges.” U.S. Br.19, Monsanto Co. v.

Hardeman, No. 21-241 (U.S. filed May 10, 2022). That

conflict has now emerged. There is no reason for

further delay. The Court should grant this petition

and resolve that conflict.

OPINIONS BELOW

The opinion of the Missouri Court of Appeals is

reported at 2025 WL 451540 and reproduced at App.212. The Missouri Supreme Court’s order denying

Petitioner’s application for transfer is unreported but

reproduced at App.1. The opinion of the Missouri trial

court denying Monsanto’s motion for summary

judgment is unreported but reproduced at App.13-16.

JURISDICTION

The Missouri Court of Appeals issued its opinion

on February 11, 2025. The Missouri Supreme Court

denied Petitioner’s application for transfer on April 1,

2025. This Court has jurisdiction under 28 U.S.C.

§1257(a).

STATUTORY PROVISIONS INVOLVED

The full text of 7 U.S.C. §136v(a)-(b) is reproduced

at App.44.

STATEMENT OF THE CASE

A. Legal Background

Congress created FIFRA through a series of

enactments to regulate the use, sale, and labeling of

pesticides. See Wis. Pub. Intervenor v. Mortier, 501

U.S. 597, 601 (1991). As originally enacted in 1947,

see Pub. L. No. 80-104, 61 Stat. 163, FIFRA “was

primarily a licensing and labeling statute.” Mortier,

501 U.S. at 601 (quoting Ruckelshaus v. Monsanto Co.,

467 U.S. 986, 991 (1984)).

In 1972, Congress

“significantly strengthened FIFRA’s registration and

labeling standards” in response to “environmental and

safety concerns.” Id.; see also Federal Environmental

Pesticide Control Act of 1972, Pub. L. No. 92-516, 86

Stat. 973.

The 1972 amendments effectively

“transformed FIFRA from a labeling law into a

comprehensive regulatory statute.” Mortier, 501 U.S.

at 601 (quoting Ruckelshaus, 467 U.S. at 991).

Under FIFRA, no pesticide may be sold or

distributed domestically without EPA registration. 7

U.S.C. §136a(a). To register a pesticide, EPA must

determine (among other things) that the pesticide

poses no unreasonable risk of adverse effects on

human health and the environment, see 7 U.S.C.

§§136a(c)(5)(C), 136(bb); 40 C.F.R. §152.112(e), and

that its labeling complies with FIFRA’s requirements,

including its misbranding prohibition, see 7 U.S.C.

§136a(c)(5)(B). “A pesticide is ‘misbranded’ if its label

contains a statement that is ‘false or misleading in any

particular,’” Bates v. Dow Agrosciences LLC, 544 U.S.

431, 438 (2005), or “does not contain a warning or

caution statement which may be necessary and if

complied with[] … is adequate to protect health and

the environment,” 7 U.S.C. §136(q)(1)(G).

EPA has published regulations that govern the

registration process. See 40 C.F.R. pt. 152. Under

those regulations, manufacturers must submit

voluminous scientific and safety data (including

carcinogenicity studies), as well as proposed labeling

that includes any precautionary statements regarding

potential effects on human health. E.g., 7 U.S.C.

§136a(c); 40 C.F.R. §§156.10(a)(1)(vii), 156.60,

158.500. EPA reviews the scientific studies and safety

data to ensure that the pesticide does not impose any

unreasonable risk of adverse effects on human health,

including cancer. And it reviews and approves the

proposed label to ensure that it complies with FIFRA’s

requirements. See 40 C.F.R. §§152.40-55. If EPA has

reason to believe a pesticide violates FIFRA’s

provisions, EPA may issue “stop sale, use, or removal”

orders, 7 U.S.C. §136k(a), seize and condemn the

offending products, id. §136k(b), and seek civil and

criminal penalties from the manufacturer, id. §136l.

EPA must review a pesticide’s registration every 15

years. Id. §136a(g)(1)(A)(iii)(II). This process requires

EPA to consider whether any “labeling changes” are

necessary given new information and whether the

product still meets FIFRA’s requirements, including

its misbranding prohibition. 40 C.F.R. §155.58(b)(4).

Pesticide registrants have a continuing obligation

to comply with FIFRA’s labeling requirements. Once

EPA approves a label, the “label is the law.” EPA,

Pesticide Registration Manual 3 (last updated April

2017), https://perma.cc/3GTB-3892. It is illegal to

distribute a pesticide with labeling substantially

different from the EPA-approved label. 7 U.S.C.

§136j(a)(1)(B). And the manufacturer must seek

approval for virtually any substantive change to that

label.

40 C.F.R. §§152.44, 152.46; 7 U.S.C.

§136a(c)(9)(C). While the manufacturer may make

some “minor modifications” through a streamlined

“notification” process, it may not change any

“precautionary statements” via that notification

process. See EPA, Office of Pesticide Programs,

Pesticide Registration Notice 2000-5 (May 10, 2000),

https://perma.cc/ANB4-UGG9;

EPA,

Office

Pesticide Programs, Pesticide Registration Notice 9810 (Oct. 22, 1998), https://perma.cc/EZ7M-62MY; 40

C.F.R. §156.70(c). Instead, for such changes, it may

proceed only by formal amendment.

FIFRA establishes a program for federal-state

cooperation in regulating pesticides. See Mortier, 501

U.S. at 601-02. Section 136v, titled “Authority of

States,” sets forth key principles of that relationship.

See 7 U.S.C. §136v. Section 136v(a) recognizes that,

as a general matter, states retain their historic

authority to regulate pesticide sale or use, provided

that a state does not permit a sale or use that FIFRA,

or EPA’s implementing regulations, prohibit:

(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 this

subchapter.

Id. §136v(a).

But when it came to labeling, FIFRA sought to

ensure that manufacturers would not have to comply

with “50 different labeling regimes.” Bates, 544 U.S.

at 452. FIFRA thus forbids a state from imposing any

additional or different requirements on pesticide

labeling or packaging than those imposed under

FIFRA:

(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

this subchapter.

7 U.S.C. §136v(b).

B. Factual Background

Monsanto produces Roundup, “a weed-killer that

employs glyphosate as its active ingredient.”

Schaffner, 113 F.4th at 373. 1 EPA has registered

pesticides containing glyphosate since 1974. See EPA,

Revised Glyphosate Issue Paper: Evaluation of

Carcinogenic Potential 12 (Dec. 12, 2017),

1 While courts have generally referred to a single Roundup

product, in reality, Monsanto has produced dozens of Roundupbranded products over the decades, each of which has been

approved by EPA for marketing without a cancer warning.

https://perma.cc/UWM2-6BHB. EPA has repeatedly

evaluated whether glyphosate is carcinogenic. Id. In

1986, for example, EPA found that the evidence did

not support a conclusion that glyphosate causes

cancer, and EPA prescribed “Required Labeling” with

no cancer warning. Id.; see also EPA, Office of

Pesticides and Toxic Substances, Guidance for the

Reregistration of Pesticide Products Containing

Glyphosate as the Active Ingredient 6-8, 20-34 (June

1986), https://perma.cc/DTH7-FR4V. In 1991, EPA’s

Carcinogenicity Peer Review Committee classified

glyphosate “as a Group E chemical: ‘Evidence of NonCarcinogenicity for Humans.’” Revised Glyphosate

Issue Paper 13. In 1993, EPA completed its statutory

re-registration of glyphosate, concluding that

“glyphosate products, labeled and used as specified [by

EPA], will not pose unreasonable risks or adverse

effects to humans.” EPA, Reregistration Eligibility

Decision (RED) Glyphosate 57 (Sept. 1993),

https://perma.cc/528H-F4FN.

And in subsequent

years, EPA has reiterated its conclusion that

glyphosate is not carcinogenic. Revised Glyphosate

Issue Paper 12-13. In 2008, for instance, EPA

determined that glyphosate is “not a carcinogen”

based on its review of an “extensive database” of

research. Glyphosate; Pesticide Tolerances, 73 Fed.

Reg. 73,586, 73,589 (Dec. 3, 2008). Public health

regulators worldwide have similarly found that

glyphosate does not cause cancer in humans. See

Hardeman, 997 F.3d at 951.

In 2015, against that global consensus, a working

group of the International Agency for Research on

Cancer (“IARC”) classified glyphosate as a “Group 2A”

agent—meaning it is, in IARC’s view, “probably

carcinogenic to humans” based on “limited” evidence

of cancer in humans.

IARC, 112 Some

Organophosphate Insecticides and Herbicides 398

(2015),

https://perma.cc/9TPL-278R.

IARC’s

classification reflected a hazard assessment, meaning

a theoretical determination of carcinogenic potential;

it did not assess the actual risk glyphosate poses

under real-world conditions. Id. at 10-11; see also In

re Roundup Prods. Liab. Litig., 390 F.Supp.3d 1102,

1108, 1113-14 (N.D. Cal. 2018) (noting the “limited”

and “abstract” nature of IARC’s assessment).

When IARC released its assessment of

glyphosate, EPA was already engaged in its statutory

registration review. During that review, the agency

developed an extensive database on the carcinogenic

potential of glyphosate, reviewing 736 studies as part

of an open literature review as well as “numerous

studies … submitted to the agency” by independent

parties. Revised Glyphosate Issue Paper 21-22. The

agency specifically examined the studies “included in

the evaluation by IARC.” Id. at 23. It further

convened a scientific advisory panel to contribute to

its analysis. After considering IARC’s classification,

EPA again determined that “[t]he strongest support”

is for classifying glyphosate as “not likely to be

carcinogenic to humans.” Id. at 143. And in 2019,

after accounting for public comments, EPA issued a

proposed registration review decision in which the

agency reiterated both its conclusion that glyphosate

is not carcinogenic to humans and its disagreement

with IARC—noting that its evaluation was “more

robust” and “more transparent” than IARC’s and

“consistent with” those of “other regulatory

authorities and international organizations.” EPA,

Glyphosate Proposed Interim Registration Review

Decision 7-8 (Apr. 2019), https://perma.cc/8K63-HD36.

EPA was hardly the only authority to reject IARC’s

findings. No shortage of national and international

health organizations rejected IARC’s position,

including the European Union’s European Chemicals

Agency, its European Food Safety Authority, and the

national health authorities of Australia, Canada,

Germany, and New Zealand. See Nat’l Ass’n of Wheat

Growers v. Bonta, 85 F.4th 1263, 1270 (9th Cir. 2023).

In an August 2019 letter rejecting a cancer

warning for glyphosate, EPA again reaffirmed its

determination that glyphosate is “not likely to be

carcinogenic to humans.” App.38. The proposed

warning, which California law automatically requires

because of IARC’s classification, would have required

manufacturers to add a label stating that glyphosate

is “known” to cause cancer. In its letter, EPA

explained that it “disagrees with IARC’s assessment”

and that it had “considered a more extensive dataset

than IARC.” App.38. “Given EPA’s determination,”

EPA concluded that a warning stating glyphosate

causes cancer would render a pesticide “misbranded

pursuant to section 2(q)(1)(A) of FIFRA.” App.39. 2

That conclusion was consistent with how state

environmental protection agencies had addressed

2 EPA more recently stated that it “could approve” labels noting

both the IARC classification and the contrary findings of EPA

and other regulatory authorities.

App.41-43.

But it

simultaneously reiterated its assessment that glyphosate is

likely not carcinogenic and its rejection of a warning that

glyphosate causes cancer. App.41-42.

glyphosate products for decades. Before California,

none had attempted to require a cancer warning.

After considering public comments for a second

time, EPA in 2020 finalized its interim registration

review determination that glyphosate does not cause

cancer, and again approved labeling with no cancer

warning. Various parties challenged that decision in

the Ninth Circuit. In response to those suits and a

change in administration, EPA again reviewed its

decision in early 2021. The agency reaffirmed the

view espoused without interruption over the last six

administrations: “[G]lyphosate is not likely to be a

human carcinogen and … it does not pose humanhealth risks of concern.” EPA.Br.17, NRDC v. EPA,

Nos. 20-70787, 20-70801 (9th Cir. May 18, 2021). The

Ninth Circuit vacated EPA’s 2020 Interim Decision in

June 2022 after concluding that the agency failed to

offer enough “analysis and explanation.” Nat. Res.

Def. Council v. U.S. Env’t Prot. Agency, 38 F.4th 34, 52

(9th Cir. 2022). Consistent with the Ninth Circuit’s

ruling, EPA announced that it will “revisit and better

explain its evaluation of the carcinogenic potential of

glyphosate,” but that “EPA’s underlying scientific

findings regarding glyphosate, including its finding

that glyphosate is not likely to be carcinogenic to

humans,” remain the same. Memorandum from

Cathryn Britton, Branch Chief, Risk Management

and Implementation Branch V, Pesticide Reevaluation Division, to Glyphosate Registration

Review Docket (EPA-HQ-OPP-2009-0361) at 5-6

(Sept. 21, 2022), https://perma.cc/3KDJ-JT2N. Since

then, EPA has continued to approve labels of

numerous glyphosate-based pesticide products

without cancer warnings. See EPA, Chemical Name:

Glyphosate, https://perma.cc/7PHA-8UXP. 3

C. Procedural History

In the wake of the IARC decision, more than

100,000 plaintiffs filed lawsuits in federal and state

courts nationwide, alleging that Roundup caused their

cancer and that Monsanto is liable for failing to warn

them of glyphosate’s purportedly carcinogenic

properties. 4

In 2016, the Judicial Panel on

Multidistrict Litigation centralized cases alleging that

Roundup caused plaintiffs’ non-Hodgkin’s lymphoma

in the Northern District of California, where several

cases were already pending. In re Roundup Prods.

Liab. Litig., 214 F.Supp.3d 1346, 1348 (J.P.M.L.

2016); see also, e.g., Hardeman v. Monsanto Co., No.

3:16-cv-00525 (N.D. Cal. filed Feb. 1, 2016). This tidal

wave of litigation forced Monsanto to remove

glyphosate from the consumer version of Roundup.

That removal—and the ongoing litigation—has

sparked fear among American farmers that Monsanto

will be forced to remove glyphosate from the

3 EPA has on at least two prior occasions approved labels that

included a cancer warning. But EPA has acknowledged that

those decisions were the result of an “implementation mistake.”

U.S. Br. at 17-19 & n.14, Monsanto Co. v. Hardeman, No. 1916636 (9th Cir. filed Dec. 20, 2019).

4 The massive volume of the litigation stems from two main

factors. First, millions of Americans have used Roundup. And

second, non-Hodgkin’s lymphoma is a common and naturally

occurring blood cancer. As of 2022, the plaintiffs’ bar had spent

an estimated $131 million on more than 625,000 television

advertisements for Roundup litigation. See T. Joyce, Am. Tort

Reform Ass’n, When Plaintiffs’ Attorneys Mislead the Public,

Bloomberg Law (Sept. 28, 2022), https://perma.cc/SV28-9BFW.

agricultural version of Roundup as well. Farmers

describe Roundup as “a fabulous tool” and “one of the

least harmful chemicals [they] use.” P. Cohen,

Roundup Weedkiller Is Blamed for Cancers, but

Farmers Say It’s Not Going Away, N.Y. Times (Sept.

20, 2019), https://perma.cc/J2LQ-BEKS.

Indeed,

farmers “continue to depend on Roundup,” especially

given global “increases [in] the demand for food.” Id.

And while the glyphosate lawsuits have been “a boon

to trial lawyers who have made a career and a fortune”

off of them, they risk forcing American farmers to

return to the “miserable,” “mind-numbing,” and “backbreaking labor” that was necessary before Monsanto

introduced glyphosate to the agricultural industry in

the 1970s. B. Hurst, Roundup Lawsuits Pose a Threat

to My Missouri Farm, Wall Street Journal (Sept. 13,

2024), https://perma.cc/M24F-TJTB.

Moreover,

removing glyphosate from shelves would force farmers

to turn to other herbicides that are “harsher, more

toxic[,] and more likely to drift and cause damage to

surrounding vegetation.” Id.

Since removing glyphosate from its consumer

version of Roundup, Monsanto has settled many

claims against it. But tens of thousands of claims

remain pending in courts across the country. This is

one of those cases.

In January 2019, Respondent John Durnell sued

Monsanto in Missouri state court, alleging that he had

developed non-Hodgkin’s lymphoma as a result of

exposure to Roundup. App.3. Durnell brought

Missouri common-law products-liability tort claims,

including strict liability defective design, strict

liability failure to warn, and negligence. App.3. Those

claims were tried to a jury in September 2023. App.3.

Both at the close of Durnell’s case in chief, as well as

after the close of all evidence, Monsanto moved for a

directed verdict on the ground that FIFRA preempts

Durnell’s claims. App.3. The court denied both

motions. App.3; see also App.17-18.

The jury ultimately found Monsanto not liable on

all of Durnell’s claims except his failure-to-warn

claim. App.3. As for the failure-to-warn claim, the

jury found Monsanto liable and awarded Durnell

$1.25 million in damages. App.3. Monsanto promptly

moved for entry of judgment notwithstanding the

verdict, again on the ground that FIFRA preempted

Durnell’s failure-to-warn claim. App.3. The trial

court again denied Monsanto’s motion and entered

final judgment, and Monsanto appealed. App.3; see

also App.19, 20-21.

On appeal, Monsanto once again argued that

FIFRA preempted Missouri’s state-law failure-towarn claims. App.4. The court rejected Monsanto’s

argument that FIFRA expressly preempts Durnell’s

failure-to-warn claim. The court recognized that

“FIFRA will preempt a state law requirement—

including a common-law cause of action—that is not

fully consistent with FIFRA’s requirements.” App.5.

Here, that analysis turns on whether the state failureto-warn claim would require Monsanto to carry a label

“in addition to or different from” the one FIFRA

required. App.5-6; 7 U.S.C. §136v(b). The court

ultimately concluded that an adverse jury verdict

would not impose an additional requirement because

the “practical effect” of FIFRA’s misbranding

prohibition and Durnell’s failure-to-warn claim “are

the same: both require a pesticide manufacturer to

adequately warn users of the potential dangers of

using its product.” App.7. Durnell’s claim therefore

did not impose a requirement “in addition to or

different from” the requirements of FIFRA. App.7.

The court acknowledged that the Third Circuit had

come to a different conclusion in Schaffner. App.10.

But because it did “not find Schaffner persuasive,” the

Court chose instead to follow decisions in the Ninth

and Eleventh Circuits rejecting Monsanto’s express

preemption arguments. App.11 (citing Hardeman,

997 F.3d 941 (9th Cir. 2021), and Carson, 92 F.4th 980

(11th Cir. 2024)).

The court also rejected Monsanto’s impliedpreemption argument. The court recognized that

state tort claims are preempted if it is “impossible to

comply with both federal and state law.” App.8. And

it acknowledged that EPA had repeatedly concluded

that glyphosate does not cause cancer in humans and

repeatedly approved Roundup labels that did not

include a cancer warning. The court nevertheless held

that that was not enough. Because Monsanto had not

specifically sought EPA’s approval to add a cancer

warning, the court could not say with certainty that

such a request for approval would be denied. App.9.

The mere “possibility of impossibility” was insufficient

to preempt Respondent’s failure-to-warn claim.

App.9. The court appeared to recognize that this

Court found impossibility preemption in similar

circumstances in PLIVA, Inc. v. Mensing, 564 U.S. 604

(2011). But the Court declined to rely on that decision

because it involved a different statutory scheme.

App.11.

REASONS FOR GRANTING THE PETITION

EPA has repeatedly determined that glyphosate,

the world’s most widely used herbicide, does not cause

cancer. EPA has consistently reached that conclusion

after studying the extensive body of science on

glyphosate for over five decades. Consistent with that

determination, EPA has approved hundreds of labels

for dozens of Roundup products without requiring a

cancer warning. EPA has not only determined that

such a warning is unnecessary under FIFRA. It has

told registrants that including a glyphosate-causescancer warning would render their products

affirmatively “misbranded” under the Act. Once EPA

approves a label, moreover, FIFRA makes it unlawful

for a pesticide manufacturer to add additional

warnings without EPA’s permission. It is thus no

surprise that Monsanto has never tried to unilaterally

include a cancer warning on its Roundup products.

Not only is such a label against the overwhelming

weight of scientific evidence, including it would have

exposed Monsanto to civil and criminal penalties

under FIFRA.

The premise of this lawsuit, however, and the

thousands like it, is that Missouri law requires

Monsanto to include the precise warning that EPA

rejects. The Third Circuit correctly held that FIFRA

squarely preempts such suits. The court below had

the benefit of that thorough, 65-page opinion, but

deemed the analysis of the Ninth and Eleventh

Circuits more persuasive. Splits of authority do not

get any clearer than that. The circuits are squarely

and irrevocably split not just on the scope of FIFRA

preemption in the abstract; they have reached

diametrically opposed conclusions

involving the exact same product.

lawsuits

The decision below is wrong. It avoided finding

preemption by distorting FIFRA’s text and misreading

this Court’s decisions. And the stakes are high. There

are tens of thousands of Roundup suits in the Missouri

court system and thousands more in state and federal

courts throughout the country. Those suits have

already forced Monsanto to remove glyphosate from

the consumer version of Roundup, and they threaten

Monsanto’s ability to continue to supply glyphosate to

farmers who need it to stay competitive. Moreover,

while there is a Roundup-specific circuit split, the

division and confusion extend to all other pesticides

subject to FIFRA and EPA jurisdiction. There is no

reason to allow this confusion to linger and every

reason for this Court to grant review.

The Decision Below Deepens A Square And

Acknowledged Circuit Split.

As the decision below recognized, and multiple

courts have acknowledged, the courts of appeals are

divided over whether FIFRA preempts state failureto-warn claims that require pesticide manufacturers

to include a warning on glyphosate products. Like the

Missouri Court of Appeals, the Ninth and Eleventh

Circuits have held that FIFRA does not preempt state

failure-to-warn claims that would require Monsanto to

warn consumers that glyphosate causes cancer. The

Third Circuit, by contrast, has squarely held that it

does.

1. Like the Missouri Court of Appeals, the Ninth

Circuit has held that FIFRA does not preempt state

failure-to-warn claims that would require pesticide

manufacturers to warn consumers that glyphosate

causes cancer. In Hardeman, the plaintiff alleged that

Monsanto’s failure to warn him of the purportedly

carcinogenic effects of Roundup caused him to develop

non-Hodgkin’s lymphoma. 997 F.3d at 952. Monsanto

argued that FIFRA preempted the plaintiff’s failureto-warn claim, but the Ninth Circuit disagreed.

According to the Ninth Circuit, a jury verdict

requiring Monsanto to add a cancer warning to

Roundup’s label would not impose a requirement “in

addition to or different from” what FIFRA already

requires because, at a general level, “FIFRA’s

requirement that a pesticide not be misbranded is

consistent with, if not broader than, California’s

common law duty to warn.” Id. at 954. The Ninth

Circuit acknowledged that EPA, applying FIFRA, has

repeatedly concluded that Monsanto was not required

to include a cancer warning for glyphosate, including

by “repeatedly register[ing] Roundup for sale without

a cancer warning on the label” and by notifying

manufacturers in 2019 that EPA would consider any

glyphosate product including a cancer warning to be

misbranded. Id. at 956. But the court deemed those

facts insufficient for express preemption, reasoning

that, because registration is not “a defense for the

commission of any offense under this subchapter,”

EPA’s approval of a label “is not conclusive of FIFRA

compliance.” Id. (quoting 7 U.S.C. §136a(f)(2)). The

court discounted EPA’s approval of Roundup and its

2019 letter because neither “carr[ied] the force of law.”

Id.

The Eleventh Circuit took the same approach as

the Ninth. In Carson, the Eleventh Circuit held that

FIFRA did not preempt the plaintiff’s failure-to-warn

claim because, at a general level, “both FIFRA and

Georgia common law require pesticide manufacturers

to warn users of potential risks to health and safety.”

92 F.4th at 992. The Eleventh Circuit recognized that,

by registering a pesticide without a cancer warning,

EPA necessarily makes “an individualized finding

that a particular pesticide is not misbranded.” Id. at

993. But, like the Ninth Circuit, the Eleventh Circuit

nevertheless deemed EPA’s registration of Roundup

irrelevant to the preemption question because EPA’s

“approvals provide only ‘prima facie evidence,’ not

conclusive proof, that a pesticide is not misbranded.”

Id. (citing 7 U.S.C. §136a(f)(2) and Hardeman, 997

F.3d at 956). And while the court acknowledged EPA’s

2019 determination that including a cancer warning

on glyphosate products would be affirmatively “false

or misleading,” the court discounted that conclusion

because it “did not foreclose any and all warnings

related to glyphosate’s potentially harmful effects”

and “did not carry the force of law.” Id. at 996. 5

2. The Third Circuit, by contrast, has squarely

held that FIFRA preempts state-law failure-to-warn

claims that would require Monsanto to warn

purchasers

about

glyphosate’s

supposedly

carcinogenic effects. The plaintiff in Schaffner alleged

that he developed non-Hodgkin’s lymphoma because

Monsanto failed to warn him of the purportedly

The California Court of Appeal and the Oregon Court of

Appeals have likewise rejected Monsanto’s argument that FIFRA

preempts state failure-to-warn claims that would require

Monsanto to warn consumers that glyphosate causes cancer. See

Pilliod, 282 Cal.Rptr.3d 679, appeal denied, No. S270957 (Cal.

Nov. 17, 2021); Johnson, 554 P.3d 290, appeal denied, 562 P.3d

237 (Or. 2024).

carcinogenic effects of glyphosate. The Third Circuit

held that FIFRA expressly preempted the plaintiff’s

claim because a jury verdict in his favor would impose

labeling requirements that are “in addition to or

different from” what EPA required in administering

FIFRA. 113 F.4th at 395-96, 399. The Third Circuit

acknowledged that the Ninth and Eleventh Circuits

had gone the other way on the theory that FIFRA’s

misbranding prohibition is, at a high “level[] of

generality,” equivalent to the common law duty to

warn. Id. at 389 (citing Carson, 92 F.4th at 991-92,

and Hardeman, 997 F.3d at 955-56). But the Third

Circuit expressly rejected the notion that a “state-law

duty can[] survive preemption simply because its

standard of liability is equivalent to the broad

statutory definition of misbranding.” Id. at 390. The

court explained that under §136v(b), “federal

requirements must be articulated at [a] more specific

level.” Id. So, if “EPA regulations specifically identify

the contents required to be included on a pesticide

label, a state-law requirement is preempted unless it

is equivalent to that specific regulatory requirement.”

Id.

Applying those principles, the Third Circuit

concluded that “EPA regulations specifically identify

the contents required to be included on” Roundup’s

label. Id. Consistent with its longstanding view that

glyphosate does not cause cancer, EPA repeatedly

registered Roundup for use and approved its label

without a cancer warning. Id. at 373-75. And because

EPA approved Roundup’s label, EPA’s regulations

prohibited Monsanto from modifying the label to

include a cancer warning without EPA’s permission.

Id. at 382-85 (citing 40 C.F.R. §152.44(a)). While EPA

regulations permit some minor modifications to a preapproved label, they do not permit changes to

“precautionary statements,” which a cancer warning

unquestionably is. Id. at 383-84. Because the

plaintiff’s state-law failure-to-warn claim would

require Monsanto to include a cancer warning that

EPA’s regulations did not require—and in fact

affirmatively forbade it from adding without EPA’s

permission—FIFRA preempted the plaintiff’s claim.

Id. at 393.

In so holding, the Third Circuit squarely rejected

the Ninth and Eleventh Circuits’ reliance on

§136a(f)(2), which specifies that registration is merely

“prima facie evidence” (rather than conclusive proof)

that the pesticide is not “misbranded.” Id. at 396

(citing Carson, 92 F.4th at 993, and Hardeman, 997

F.3d at 956). The Third Circuit explained that while

registration alone is not “dispositive” as to whether a

pesticide is “misbranded,” EPA’s treatment of

Roundup disposes of the preemption question. After

all, once EPA approved Roundup’s label, EPA’s

regulations prohibited Monsanto from adding new

“precautionary statements” to the label—including

the cancer warning requested by the plaintiff in that

case. Id. at 396-97.

The Third Circuit likewise rejected the Ninth and

Eleventh Circuits’ “force of law” analysis. Id. at 398 &

n.20. As the Third Circuit explained, force of law

analysis generally has no place when interpreting an

express preemption provision. Id. at 398. Because

“Congress has decreed in the text of [FIFRA] that

federal ‘requirements’ have preemptive force, no

further analysis is necessary” once a FIFRA

“requirement” is identified. Id. at 398 (citation

omitted). And FIFRA’s restriction on changing a preapproved label was just that. Schaffner sought

rehearing en banc, noting that the Third Circuit had

“split[] expressly from the Ninth and Eleventh

Circuits,” En Banc Pet. at 3-4, Schaffner v. Monsanto

Corp., No. 22-3075 (3d Cir. filed Sept. 12, 2024), but

the court denied the petition without any judge calling

for a response, let alone recording a dissent. 6

In short, the circuits are squarely divided over

“whether, once the [EPA] registers and approves a

pesticide label that omits a particular health warning,

a state-law duty to include that warning is

preempted.” Schaffner, 113 F.4th at 370-71. More

specifically, the circuits are divided over whether

FIFRA preempts state-law failure-to-warn claims that

seek to impose liability on pesticide manufacturers for

failing to warn consumers that glyphosate causes

cancer. Like the Missouri Court of Appeals, the Ninth

and Eleventh Circuits and the California and Oregon

appellate courts have held that FIFRA does not

preempt such claims. On the other side of the split,

the Third Circuit has held that it does. There is no

realistic chance that the split will resolve itself given

Massachusetts and Hawaii courts have likewise held that

FIFRA preempts state-law claims that seek to hold Monsanto

liable for failing to include a cancer warning on its Roundup

products. See Mem. of Decision and Order on Defs.’ Mot. for

Summ. J., Dkt. 40, Cardillo v. Monsanto Co., No. 2177CV00462

(Mass. Super. Ct. filed Oct. 21, 2024), appeal granted, No. 2024P-1382 (Mass. filed Feb. 24, 2025); Order Granting Def.’s Mot. for

Partial Summ. J., Dkt. 1058, Peters v. Monsanto Co., No. 1CCV20-0001630 (Haw. Cir. Ct. filed Oct. 25, 2023), appeal granted,

id., Dkt. 1166 (filed Mar. 13, 2024).

the Third Circuit’s denial of en banc review. Only this

Court can resolve the conflict on this important issue

of law.

II. The Decision Below Is Wrong.

The decision below not only deepens an

acknowledged circuit split, it distorts the text of

FIFRA and this Court’s precedents. When a state tort

claim requires a pesticide manufacturer to add a

warning that EPA has repeatedly concluded is not

only unnecessary, but also “false and misleading,”

FIFRA preempts that claim. See App.39. Any other

rule would undermine the nationwide “[u]niformity”

in pesticide labeling that Congress set out to achieve.

1. FIFRA expressly preempts state laws that

impose “any requirements for labeling or packaging in

addition to or different from those required under this

subchapter.” 7 U.S.C. §136v(b). Respondent claims

that Monsanto violated a state-law duty to warn

consumers that glyphosate causes cancer. Because

the term “requirements” in §136v(b) includes

“common-law duties” that “set a standard for a

product’s labeling,” Bates, 544 U.S. at 443, 446,

Respondent’s claim unquestionably seeks to impose a

“requirement[] for labeling or packaging.” 7 U.S.C.

§136v(b). The only question is whether it imposes a

requirement that is “in addition to or different from”

what EPA requires in administering FIFRA. Text,

precedent, and common sense confirm that it does.

A state labeling requirement is “in addition to or

different from those required under” FIFRA if it

“diverges from those set out in FIFRA and its

implementing regulations.” Bates, 544 U.S. at 442-43,

452. As this Court made clear in Bates, it is not

enough for a state requirement to be “nominally

equivalent[]” to what FIFRA demands. Id. at 454.

The “state-law labeling requirement must in fact be

equivalent to a requirement under FIFRA in order to

survive pre-emption.” Id. at 453 (emphasis added).

The quintessential example of such a “parallel

requirement” under Bates is a state tort claim that

simply provides a damages remedy for a violation of

the existing federal labeling standards. Id. at 448. A

“manufacturer should not be held liable under a state

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

manufacturer is also liable” for misbranding under

FIFRA. Id. at 454.

Respondent’s failure-to-warn claim plainly

imposes a labeling requirement that is “in addition to

or different from” what EPA requires in administering

FIFRA. After all, this is not a case in which the

plaintiff is seeking to impose a state-law labeling

requirement on which EPA has “never passed,” such

as the pesticide’s efficacy. See id. at 440. Since

Monsanto introduced Roundup in 1974, “EPA has

repeatedly evaluated the health risks posed by

glyphosate,” Schaffner, 113 F.4th at 373, and it has

“repeatedly … conclud[ed] that it is not likely to be

carcinogenic to humans,” Hardeman, 997 F.3d at 951.

Consistent with that conclusion, EPA has repeatedly

approved labels for Roundup that do not include a

cancer warning.

Those approvals trigger preemption. As the Third

Circuit explained, EPA’s approvals necessarily

“identify the contents required to be included on a

pesticide label,” Schaffner, 113 F.4th at 390, because

EPA’s approval locks a manufacturer’s label in place.

EPA regulations forbid manufacturers from adding

new “precautionary statements” without prior EPA

approval. A jury verdict requiring Monsanto to add a

new cancer warning to Roundup’s label is

irreconcilable with that regime.

It necessarily

requires a jury to determine that there was some

warning that the manufacturer could have included

on the label but failed to. But under EPA’s rules, there

is no additional warning the manufacturer can add on

its own—and certainly not a statement that EPA has

determined would render the product misbranded.

See App.39.

State law effectively tells the

manufacturer “add this warning,” while federal law

tells it “do not.” Because the jury verdict in this case

requires Monsanto to include a cancer warning that

EPA’s regulations did not require—and in fact

affirmatively forbade it from adding—FIFRA

preempts Respondent’s claim.

This Court’s decision in Riegel v. Medtronic, Inc.,

552 U.S. 312 (2008), confirms that conclusion. Riegel

addressed the scope of preemption under the Medical

Device Amendments of 1976 (“MDA”), Pub. L. No. 94295, 90 Stat. 539, a statute with a similarly worded

preemption provision. See 21 U.S.C. §360k(a)(1)

(prohibiting states from imposing a requirement for a

medical device “which is different from, or in addition

to, any requirement applicable under this chapter to

the device”); see also Bates, 544 U.S. at 447 (noting

that FIFRA and MDA express preemption provisions

are “similarly worded”). “[T]he MDA’s system of

premarket approval” also “operates very similarly to

pesticide registration under FIFRA.” Schaffner, 113

F.4th at 387. In particular, like pesticides under

FIFRA, “medical devices must be reviewed and

approved before being marketed, and once approved

they cannot be modified unless the proposed

modification is itself reviewed and approved.” Id. at

387-88.

Riegel held that FDA’s “premarket approval” of a

device “imposes ‘requirements’” for purposes of the

MDA’s preemption provision. 552 U.S. at 322-23. The

Court reasoned that “a device that has received

premarket approval” must “be made with almost no

deviations from the specifications in its approval

application,” since “the FDA has determined that the

approved form provides a reasonable assurance of

safety and effectiveness.” Id. at 323. And as the Third

Circuit recognized, that analysis “carries over to

FIFRA.” Schaffner, 113 F.4th at 388. “If the

prohibition on modifying medical devices following

their approval for safety establishes ‘requirements’ for

medical devices, then FIFRA’s regulatory approach,

which employs the same two elements, should

likewise establish ‘requirements’ under [FIFRA’s]

similar preemption provision[.]” Id. at 388-89.

The Missouri Court of Appeals concluded

otherwise by assessing FIFRA’s requirements at too

high a level of generality. According to the court,

Missouri common law “is fully consistent with”

FIFRA’s misbranding provision because “both require

a pesticide manufacturer to adequately warn users of

the potential dangers of using its product.” App.6-7.

That reasoning cannot be squared with this Court’s

decision in Bates. As the Court explained in that case,

the question is not whether state and federal law have

“nominally equivalent” labeling standards. Bates, 544

U.S. at 454. The question is whether the state imposes

a labeling requirement for a particular pesticide that

is in fact different from what EPA requires for that

pesticide. Id. at 453. That is why Bates explained that

FIFRA preempts a state law that requires a label for

a particular pesticide to say “DANGER” when EPA

has determined that it should say “CAUTION”

instead. Id. But under the decision below, the statelaw requirement to use “DANGER” on a pesticide label

“would not be preempted so long as the label satisfies

the statutory definition of misbranding.” Schaffner,

113 F.4th at 390-91.

Assessing FIFRA’s requirements at such a high

level of generality would render FIFRA’s “Uniformity”

provision largely meaningless. Under that approach,

virtually all failure-to-warn claims are “consistent”

with FIFRA’s misbranding provision, because

virtually all failure-to-warn claims require (as

FIFRA’s

misbranding

provision

does)

the

manufacturer to “adequately warn users of the

potential dangers of using its product.” App.7. Under

the decision below, a jury would be free to impose

liability on pesticide manufacturers for failing to

include all manner of warnings, no matter how

different they are from what EPA requires. Worse

still, different juries in different states could impose

countless different requirements, directly impeding

the uniformity Congress sought to achieve through

§136v(b). As the Third Circuit recognized, “[s]tate-law

duties framed in these vague and broad terms would

produce considerable heterogeneity, not uniformity, in

the labels that pesticides are required to bear, for

different factfinders deciding different individual

cases might reasonably disagree about whether a

particular warning was necessary to protect health.”

Schaffner, 113 F.4th at 393.

Nor does §136a(f)(2) support the decision below.

That provision, located elsewhere in the statute and

grouped with other provisions in a subsection labeled

“Miscellaneous,” simply says that “registration” of a

pesticide under FIFRA is not “a defense for the

commission of any offense under this subchapter” but

is “prima facie evidence” that a pesticide’s labeling

“compl[ies] with the registration provisions of the

subchapter.” 7 U.S.C. §136a(f)(2). That provision has

“no bearing on” preemption. MacDonald v. Monsanto

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

114 F.3d at 396-97. It simply “stands for the

unremarkable proposition that a registration is not a

defense against an allegation that a product violates

the terms of that registration.” Reckitt Benckiser, Inc.

v. Jackson, 762 F.Supp.2d 34, 45 (D.D.C. 2011). If it

were otherwise, then EPA’s determination that a

warning label is unnecessary (or, as here, false and

misleading) would never be preemptive. The result

would be the very proliferation of divergent state and

federal labeling requirements Congress sought to end.

2. Respondent’s failure-to-warn claim is doubly

preempted because it is “impossible” for Monsanto “to

comply with both state and federal requirements.”

Mut. Pharm. Co. v. Bartlett, 570 U.S. 472, 480 (2013).

In the context of labeling requirements, impossibility

arises where the warning could not have been added

without prior federal approval, see PLIVA, 564 U.S. at

617-19.

Here, Monsanto could not have added the label

required by the jury verdict in this case without prior

federal approval. In PLIVA, this Court held that a

state-law failure-to-warn claim is preempted where

federal law bars a manufacturer from adopting,

without prior federal approval, a labeling change that

state law requires. Id. at 617-18. It is irrelevant,

PLIVA held, whether the manufacturer might have

persuaded the relevant agency to approve that

change. Id. at 619. Because “[t]he question for

‘impossibility’ [preemption] is whether the private

party could independently do … what state law

requires,” state law is preempted wherever the

manufacturer’s ability to comply with state law

depends upon prior agency approval. Id. at 620

(emphasis added).

That is the case here. Selling a pesticide with

labeling that makes “any claims” “substantially

differ[ent]” from the EPA-approved labeling is

unlawful. 7 U.S.C. §136j(a)(1)(B), (2)(G); see also id.

§136a(a). And pesticide manufacturers may not

change substantive aspects of their products’ labeling

without EPA’s prior approval. See 40 C.F.R. §§152.44,

156.70(c); Pesticide Registration Notice 2000-5. To

change labeling, a manufacturer must submit an

amended registration application that includes all

data relevant to the change. See id. §§152.44(a),

152.50. “[T]he application must be approved by [EPA]

before the product, as modified, may legally be

distributed or sold.”

Id. §152.44(a). Like the

manufacturer in PLIVA, therefore, Monsanto could

not have “independently do[ne] … what state law

require[d].” PLIVA, 564 U.S. at 620. Nor could

Monsanto have added a cancer warning to Roundup’s

label via EPA’s “notification” procedure, as changes to

precautionary statements may not be made without

prior agency approval. See Pesticide Registration

Notice 2000-5; Pesticide Registration Notice 98-10.

Even if FIFRA did not expressly bar Monsanto

from adding a cancer warning on its own, EPA would

unquestionably reject any attempt to add a cancer

warning to Roundup. For decades, EPA has assessed

the carcinogenic potential of glyphosate and

consistently approved both glyphosate and Roundup’s

labeling without a cancer warning. See supra at 7-8.

Even after the IARC working group’s “hazard

identification,” EPA—following a “systematic review,”

including of all studies IARC considered—confirmed

the conclusion it has reached for years: Glyphosate is

“not likely to be carcinogenic to humans.” Supra at 810. EPA eliminated any remaining doubt in 2019

when it informed all glyphosate registrants that,

“[g]iven EPA’s determination that glyphosate is ‘not

likely to be carcinogenic to humans,’” EPA considers

any warning that glyphosate is carcinogenic “to

constitute a false and misleading statement” that

violates FIFRA’s prohibition against “misbranded”

substances. App.39. 7

7 While EPA’s 2022 letter suggested that EPA might approve a

warning that advised consumers both of California’s

determination that Roundup poses cancer risks and of EPA’s

disagreement with that determination, Respondent did not ask

for this type of warning at trial. Moreover, Respondent’s

exposure to glyphosate ceased in 2012—five years before

California categorized glyphosate as carcinogenic and three years

before the IARC report that triggered that categorization.

Monsanto thus could not have known to propose the kind of

warning the 2022 letter suggests. That letter, moreover,

reaffirms EPA’s 2019 conclusion that a warning stating that

The Missouri Court of Appeals rejected all that on

the ground that none of EPA’s actions carried “the

force of law.” App.9-10. But EPA’s actions approving

Roundup’s labeling without a cancer warning are

comparable to the agency actions the Court identified

as sufficient to “answer … the pre-emption question”

in Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S.

299, 315 (2019). This Court explained in Merck that

“agency actions taken pursuant to the [agency’s]

congressionally delegated authority” can establish

that the agency would not have taken a particular

action for conflict-preemption purposes. Id. The

Court listed three ways FDA is authorized to

“communicate its disapproval of a warning” and thus

“answer … the pre-emption question”: (1) “notice-andcomment

rulemaking

setting

forth

labeling

standards,” (2) “formally rejecting a warning label

that would have been adequate under state law,” and

(3) “other agency action carrying the force of law.” Id.

at 315-16. 8

EPA has taken analogous actions in approving

Roundup’s labeling.

First, in conducting its

statutorily required re-registration in 1993, EPA

engaged in formal statutory procedures, see 7 U.S.C.

§136a-1, and went through the notice-and-comment

glyphosate is known to cause cancer would be misbranded, which

is the kind of warning Respondent sought.

As an example of the kind of action satisfying the final

category, the Court pointed to a provision requiring the FDA to

notify the manufacturer if it “becomes aware of new

information … that [it] determines should be included in the

labeling of [a] drug,” 21 U.S.C. §355(o)(4)(A). Merck, 587 U.S. at

316.

process before reaffirming its conclusion that

“glyphosate products, labeled and used as specified [by

EPA], will not pose unreasonable risks or adverse

effects to humans.” EPA, Reregistration Eligibility

Decision (RED) Glyphosate 57 (Sept. 1993). Second,

EPA has notified glyphosate registrants in a letter

that it would not approve glyphosate labeling

containing a warning that glyphosate causes cancer.

App.38-40. And EPA has declined to require a cancer

warning through its registration review process or its

approval of individual labels—a process that (like the

FDA notification requirement discussed in Merck)

requires EPA to propose “labeling changes” when

necessary, 40 C.F.R. §155.58(b)(4), and requires EPA

to determine that the label contains all necessary

health warnings.

III. The Question Presented Is Important, And

This Case Is An Ideal Vehicle To Resolve It.

1. The question presented is critically important,

and the stakes are high. The decision below is just one

of tens of thousands of pending tort suits in

Monsanto’s home state of Missouri. And the litigation

is hardly limited to Missouri, as thousands more suits

remain pending in state and federal courts across the

nation. Simply litigating those suits is financially

draining, and losing them in jurisdictions that have

erroneously rejected a preemption defense is more

costly still.

Not only can manufacturers find

themselves on the hook for significant sums in

compensatory damages stemming from the plaintiffs’

injuries, but in many states, they may also be liable

for punitive damages too. See, e.g., Home Ins. Co. v.

Am. Home Prods. Corp., 550 N.E.2d 930, 935 (N.Y.

1990); Fischer v. Johns-Manville Corp., 512 A.2d 466,

480 (N.J. 1986). Those jury verdicts can be exorbitant.

See, e.g., D. Cameron & P. Thomas, Bayer Told to Pay

$1.56 Billion After Losing Roundup Case, Wall Street

Journal (Nov. 18, 2023), https://perma.cc/MZP4HANE; H. Smolak, Bayer Shares Fall After Jury

Orders $2.25 Billion in Damages in Roundup Case,

Wall

Street

Journal

(Jan.

29,

2024),

https://perma.cc/7ZMD-75JH. The cost of managing

this veritable flood of litigation has already forced

Monsanto to remove glyphosate from the consumer

version of Roundup. It threatens Monsanto’s ability

to supply the product to farmers who depend on it for

their livelihoods. And it undermines the United

States’ position as a world leader in agriculture. See

supra at 12-13. The stakes for glyphosate alone are

therefore enormous.

But as unusual as it is to have a clear circuit split

involving a single product line, the consequences of the

question presented are hardly limited to glyphosate

and Monsanto and other manufacturers of pesticides

that include glyphosate. Instead, the divide among

the circuits extends to any pesticide that has been

studied by EPA and deemed safe for use with an EPAapproved label. More broadly, the decision below and

the Ninth and Eleventh Circuit decisions it follows

threaten to undermine Congress’s statutory goal of

ensuring uniformity in pesticide labeling laws, thus

restoring the pre-1972 status quo Congress sought to

replace. Congress enacted the “[u]niformity” provision

specifically to address the chaos and confusion in the

pesticide industry engendered by the dozens of

disparate state pesticide-labeling regimes. Bates, 544

U.S. at 452 n.26. The “crazy-quilt” of “conflicting state

labeling

regulations”

produced

“significant

inefficiencies for manufacturers,” which could not

simultaneously comply with the rules established in

each of the nation’s many jurisdictions. Id. at 448,

452, 453 n.26. Congress sought to impose a uniform

regime of pesticide labeling by preempting state

efforts to impose labeling requirements that are in

addition to or different from what FIFRA requires. 7

U.S.C. §136v(b).

Decisions like the one below disrupt that design.

By allowing state failure-to-warn claims to impose

labeling rules in addition to those Congress imposed

through FIFRA, such decisions permit precisely what

Bates feared: “50 different labeling regimes

prescribing the … wording of warnings,” creating

“significant inefficiencies for manufacturers.” Bates,

544 U.S. at 452. Indeed, this new state of affairs is

even worse than the patchwork Congress attempted to

eliminate. Before Congress enacted the “[u]niformity”

provision, state labeling regulations typically took the

form of state statutes. See, e.g., Mont. Rev. Codes Ann.

§§27-213 et seq. (1971); N.C. Gen. Stat. §§143-434–70

(1971); N.H. Rev. Stat. §§149-D:1-11 (1972). As

difficult as it was to comply with multiple statutory

labeling requirements, attempting to comply with the

requirements reflected in disparate jury verdicts

across the country is downright impossible. Those

unpredictable and varying requirements create

headaches for consumers and manufacturers alike.

Cf. Turek v. Gen. Mills, Inc., 662 F.3d 423, 426 (7th

Cir. 2011) (“Manufacturers might have to print 50

different labels, driving consumers who buy

[pesticides] in more than one state crazy.”).

2. Nor are the stakes limited to the FIFRA

context.

FIFRA’s express preemption language

appears in a wide range of other statutes, such that

any preemption analysis adopted in the FIFRA

context will inevitably carry over to those other

schemes.

The text that governs the scope of preemption

under FIFRA—including its focus on preempting state

“requirements” that are “in addition to or different

from” those under federal law, 7 U.S.C. §136v(b)—

appears in a variety of statutes, including those

regulating medical devices, poultry products, meat,

and motor vehicles. See 21 U.S.C. §360k(a) (MDA)

(preempting certain state “requirement[s]” that are

“different from, or in addition to, any requirement

applicable under” the statute); id. §467e (Poultry

Products Inspection Act) (preempting certain state

“[r]equirements … which are in addition to, or

different than those made under” the statute); id. §678

(Federal Meat Inspection Act (“FMIA”)) (preempting

certain state “[r]equirements … which are in addition

to, or different than those made under” the statute);

see also 49 U.S.C. §30103(b) (National Traffic and

Motor Vehicle Safety Act) (generally preempting state

motor vehicle safety standards not “identical to the

standard[s] prescribed under” the statute).

That similarity magnifies the impact of the

FIFRA preemption split because courts are “guided

by … prior decisions interpreting similar language in

other … statutes.” Gomez-Perez v. Potter, 553 U.S.

474, 479 (2008); see also Riegel, 552 U.S. at 324

(“Congress is entitled to know what meaning this

Court will assign to terms regularly used in its

enactments.”).

Indeed, courts routinely look to

decisions interpreting similar statutory language

when determining the scope of express preemption

provisions in particular. See, e.g., Bates, 544 U.S. at

447-48 (relying on the interpretation of the MDA’s

similar preemption provision in Medtronic, Inc. v.

Lohr, 518 U.S. 470 (1996)); Thornton v. Tyson Foods,

Inc., 28 F.4th 1016, 1026 (10th Cir. 2022) (FMIA)

(citing Bates); McMullen v. Medtronic, Inc., 421 F.3d

482, 488-89 (7th Cir. 2005) (relying on Bates in

applying the MDA’s preemption provision).

All of this means that the conflicting preemption

frameworks that the Third, Ninth, and Eleventh

Circuits have adopted in the FIFRA context are likely

to confuse the preemption analysis that courts employ

in those other statutory schemes.

3. This case is an excellent vehicle to resolve the

question presented.

While Respondent initially

brought numerous claims against Monsanto, the jury

ruled for him on only a single claim: failure to warn.

The upshot is that the sole claim in front of this Court

undeniably concerns labeling and packaging, and

there are no other state-law claims that might

complicate the Court’s review. Likewise, the sole issue

that Monsanto raised on appeal was the preemption

question. And there are no obstacles that would

prevent the Court from considering that issue.

Finally, now that a clear circuit split has emerged,

there is no reason to delay plenary review. To the

contrary, the agricultural community needs clarity

about glyphosate’s continuing availability and the

FIFRA labeling regime more broadly, which governs

hundreds of federally regulated registered products.

Moreover, approximately 30 trials are currently

scheduled to occur over the course of 2025, and

approximately 50 more in 2026. In short, there is no

reason for further delay and every reason for this

Court to grant review.

CONCLUSION

For the foregoing reasons, this Court should grant

the petition for certiorari.

Respectfully submitted,

DAVID M. ZIONTS

PAUL D. CLEMENT

MICHAEL X. IMBROSCIO Counsel of Record

COVINGTON &

MATTHEW D. ROWEN

BURLING LLP

JAMES Y. XI

One CityCenter

NICCOLO A. BELTRAMO*

850 Tenth Street NW CLEMENT & MURPHY, PLLC

Washington, DC 2001 706 Duke Street

(202) 662-6000

Alexandria, VA 22314

(202) 742-89000

K. LEE MARSHALL

paul.clement@clementmurphy.com

BRYAN CAVE

LEIGHTON PAISNER *Supervised by principals of the

Three Embarcadero

firm who are members of the

Center

Virginia bar

San Francisco, CA 94111

Counsel for Petitioner

April 4, 2025

APPENDIX

TABLE OF APPENDICES

Appendix A

Order, Supreme Court of Missouri,

Durnell v. Monsanto Co., No. SC100975

(Apr. 1, 2025) ............................................... App-1

Appendix B

Opinion, Missouri Court of Appeals,

Durnell v. Monsanto Co., No. ED112410

(Feb. 11, 2025) ............................................. App-2

Appendix C

Order, Missouri Circuit Court, TwentySecond

Judicial

Circuit,

Durnell

v. Monsanto Co., No. 1922-CC00221

(Sept. 28, 2023) .......................................... App-13

Appendix D

Order, Missouri Circuit Court, TwentySecond

Judicial

Circuit,

Durnell

v. Monsanto Co., No. 1922-CC00221

(Oct. 17, 2023) ............................................ App-17

Appendix E

Order, Missouri Circuit Court, TwentySecond

Judicial

Circuit,

Durnell

v. Monsanto Co., No. 1922-CC00221

(Oct. 19, 2023) ............................................ App-18

Appendix F

Order and Judgment, Missouri Circuit

Court, Twenty-Second Judicial Circuit,

Durnell v. Monsanto Co., No. 1922CC00221 (Jan. 19, 2024) ........................... App-19

Appendix G

Judgment, Missouri Circuit Court,

Twenty-Second Judicial Circuit, Durnell

v. Monsanto Co., No. 1922-CC00221

(June 24, 2024) .......................................... App-20

Appendix H

United States Environmental Protection

Agency Memorandum re: Withdrawal of

the Glyphosate Interim Registration

Review Decision (Sept. 21, 2022) .............. App-22

Appendix I

Letter

From

United

States

Environmental

Protection

Agency

Re: Glyphosate (Aug. 7, 2019) ................... App-38

Appendix J

Letter from United States Environmental

Protection Agency to Lauren Zeise, Office

Environmental

Health

Hazard

Assessment, California Environmental

Protection Agency (Apr. 8, 2022) .............. App-41

Appendix K

Relevant Statutory Provision.................... App-44

7 U.S.C. §136v(a)-(b) ........................... App-44

App-1

Appendix A

SUPREME COURT OF MISSOURI

________________

No. SC100975

________________

JOHN L. DURNELL,

Respondent,

MONSANTO COMPANY,

Appellant.

________________

Filed: April 1, 2025

________________

ORDER

________________

Appellant’s application for transfer from Missouri

Court of Appeals, No. ED112410, is denied.

App-2

Appendix B

MISSOURI COURT OF APPEALS

FOR THE EASTERN DISTRICT

________________

No. ED112410

________________

JOHN L. DURNELL,

Respondent,

MONSANTO COMPANY,

Appellant.

________________

Filed: Feb. 11, 2025

________________

OPINION

________________

Monsanto Company (“Monsanto”) appeals the

judgment entered upon a jury verdict in favor of John

L. Durnell (“Plaintiff”) on Plaintiff’s claim for strict

liability failure to warn. The trial court’s judgment

entered upon the jury’s verdict awarded Plaintiff

$1.25 million in compensatory damages. We affirm.1

1 Monsanto filed a motion, which was taken with the case,

requesting this Court to take judicial notice of certain materials

“which document or relate to key aspects of glyphosate’s

regulatory history at the federal and state levels.” We deny

Monsanto’s motion taken with the case.

App-3

BACKGROUND

In January 2019, Plaintiff sued Monsanto

alleging his exposure to Monsanto’s product Roundup

and its ingredient glyphosate caused him to develop

non-Hodgkin’s lymphoma (“NHL”). Plaintiff’s petition

alleged claims for strict liability defective design,

strict liability failure to warn, and negligence.

The case proceeded to a jury trial beginning in

September 2023. At the close of Plaintiff’s evidence

and again at the close of all the evidence, Monsanto

moved for a directed verdict on the grounds that, inter

alia, Plaintiff’s claims were expressly and impliedly

preempted by federal law. The trial court denied both

motions for directed verdict.

The jury returned a verdict in favor of Plaintiff on

his strict liability failure to warn claim, but found in

favor of Monsanto on Plaintiff’s strict liability

defective design and negligence claims. The jury

awarded Plaintiff $1.25 million in compensatory

damages, and the trial court entered its judgment in

accordance with the jury’s verdicts. Monsanto

subsequently filed a motion for judgment

notwithstanding the verdict (“JNOV”) and in the

alternative a new trial, which again argued, inter alia,

that federal law both expressly and impliedly

preempted Plaintiff’s strict liability failure to warn

claim. The trial court denied Monsanto’s motion. This

appeal followed.2

2 To avoid unnecessary repetition, additional facts relevant to

Monsanto’s point on appeal will be set forth in Section II.B. of

this opinion.

App-4

II. DISCUSSION

Monsanto raises a single point on appeal arguing

the trial court erred in denying its motion for JNOV

because federal law both expressly and impliedly

preempted Plaintiff’s strict liability failure to warn

claim (“failure to warn claim” or “claim”).

A. Standard of Review

“Federal preemption is a question of law this

Court reviews de novo.” Collector of Winchester v.

Charter Communications, Inc., 660 S.W.3d 405, 416

(Mo. App. E.D. 2022). Similarly, the trial court’s ruling

challenged by Monsanto on appeal—the denial of a

motion for JNOV based on a matter of law—raises a

question of law requiring de novo review. See Boggs ex

rel. Boggs v. Lay, 164 S.W.3d 4, 15 (Mo. App. E.D.

2005).

B. Analysis of Monsanto’s Sole Point on Appeal

When analyzing federal preemption of a state

cause of action, “[i]t is assumed that the historic police

powers of the state are not preempted absent ‘the clear

and manifest purpose of Congress’ to do so.” Connelly

v. Iolab Corp., 927 S.W.2d 848, 851 (Mo. banc 1996)

(quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218,

230 (1947)). “[T]he purpose of Congress in enacting the

federal statute is the ultimate touchstone” in our

analysis. Connelly, 927 S.W.2d at 851 (citing Malone

v. White Motor Corp., 435 U.S. 497, 504 (1978)).

Furthermore, preemption of state law by statute may

be either express or implied. Cooperative Home Care,

Inc. v. City of St. Louis, 514 S.W.3d 571, 579 (Mo. banc

2017). In this case, Monsanto argues Plaintiff’s failure

to warn claim is both expressly and impliedly

App-5

preempted by federal law, and we proceed by

addressing each type of preemption in turn below.

Express Preemption

Express preemption occurs when a federal statute

explicitly proscribes a local regulation in a specific

area. Id.; Stegall v. Peoples Bank of Cuba, 270 S.W.3d

500, 503 (Mo. App. S.D. 2008). The Federal

Insecticide,

Fungicide,

and

Rodenticide

Act

(“FIFRA”)—the federal statutory scheme which

Monsanto argues expressly preempted Plaintiff’s

failure to warn claim—regulates the use, sale, and

labeling of pesticides. See 7 U.S.C. section 136 et seq.;

Carson v. Monsanto Company, 92 F.4th 980, 986 (11th

Cir. 2024). FIFRA contains an express preemption

provision at 7 U.S.C. section 136v(b) (“section

136v(b)”) which provides that a “[s]tate shall not

impose or continue in effect any requirements for

labeling or packaging in addition to or different from

those required under” FIFRA. Section 136v(b). In

other words, FIFRA will preempt a state law

requirement—including a common-law cause of

action—that is not fully consistent with FIFRA’s

requirements. Id.; Carson, 92 F.4th at 990-91 (citing

Bates v. Dow Agrosciences LLC, 544 U.S. 431, 447

(2005)). A state law requirement is not fully consistent

with FIFRA’s requirements when the state law

requirement is: (1) for labeling or packaging; and (2) in

addition to or different from what FIFRA requires.

Section 136v(b); Carson, 92 F.4th at 989-91 (citing

Bates, 544 U.S. at 444, 446-47).

Monsanto does not dispute on appeal that

Plaintiff’s successful failure to warn claim is a

common-law action which effectively imposes a state

App-6

law requirement for labeling upon Monsanto.3

Accordingly, the dispositive question as to express

preemption in this case is whether Plaintiff’s failure to

warn claim imposes a requirement that is “in addition

to or different from” FIFRA’s labeling requirements.

See id.

FIFRA’s labeling requirements under 7 U.S.C.

section 136(q)(1)(G) (“section 136(q)(1)(G)”) contain a

prohibition on misbranding. Id.; Carson, 92 F.4th at

991. Section 136(q)(1)(G) provides in relevant part

that “[a] pesticide is misbranded if . . . the label does

not contain a warning or caution statement which may

be necessary and if complied with . . . is adequate to

protect health and the environment.” Id. This

“prohibition on misbranding effectively imposes a

strict-liability standard,” holding a manufacturer

liable for omitting a warning regardless of knowledge

or intent. Carson, 92 F.4th at 991-92.

Missouri’s strict liability failure to warn cause of

action is fully consistent with federal requirements

under section 136(q)(1)(G) of FIFRA. See Carson, 92

F.4th at 986-87, 991-92 (similarly finding with respect

to a failure to warn cause of action under Georgia state

law). A claim for strict liability failure to warn under

Missouri law requires a plaintiff to prove, inter alia,

that a defendant “did not give adequate warning of the

danger” of a product, and contains no element

3 Under the count for strict liability failure to warn, Plaintiff’s

petition alleges Monsanto’s Roundup products are “unreasonably

dangerous to consumers . . . because they do not contain

adequate warnings or instructions[.]” The count also specifically

alleges “Monsanto had a duty to properly . . . label” Roundup

products.

App-7

requiring proof of the defendant’s knowledge or intent.

Moore v. Ford Motor Co., 332 S.W.3d 749, 756 (Mo.

banc 2011); MAI-Civil 25.05 8th ed. (1978 revision).4

The “practical effect” of both FIFRA’s prohibition on

misbranding under section 136(q)(1)(G) and a strict

liability failure to warn claim in Missouri are the

same: both require a pesticide manufacturer to

adequately warn users of the potential dangers of

using its product, regardless of the manufacturer’s

knowledge or intent. See id.; Moore, 332 S.W.3d at 756;

MAI-Civil 25.05; Carson, 92 F.4th at 992; see also

Bates, 544 U.S. at 447 (“state law need not explicitly

incorporate FIFRA’s standards as an element of a

cause of action in order to survive pre-emption”).

Based on the foregoing, a strict liability failure to

warn claim in Missouri does not impose a requirement

“in addition to or different from” the requirements of

FIFRA. See Moore, 332 S.W.3d at 756; MAI-Civil

25.05; sections 136(q)(1)(G) and 136v(b); Carson, 92

F.4th at 986-87, 989-92. Accordingly, section 136v(b)

of FIFRA does not expressly preempt Plaintiff’s strict

liability failure to warn claim. See id.; Moore, 332

S.W.3d at 756; MAI-Civil 25.05; section 136(q)(1)(G);

Carson, 92 F.4th at 986-87, 989-92 (similarly holding);

Hardeman v. Monsanto Company, 997 F.3d 941, 95458 (9th Cir. 2021) (similarly holding).

Implied Preemption

Although we find Plaintiff’s failure to warn claim

is not expressly preempted, we must also address

Monsanto’s argument that implied preemption bars

4 All references to MAI-Civil 25.05 are to the 8th ed. (1978

revision).

App-8

Plaintiff’s claim. See Mizner v. North River Homes,

Inc., 913 S.W.2d 23, 25 (Mo. App. E.D. 1995) (implied

preemption is still possible where an express

preemption provision is present). Monsanto argues on

appeal that conflict preemption bars Plaintiff’s failure

to warn claim because federal law5 mandates that

warnings on pesticide labels be approved by the

Environmental Protection Agency (“EPA”), therefore

making it impossible for Monsanto to comply with any

warning that Plaintiff’s claim under Missouri law

would require.

Federal law can impliedly preempt state law

through conflict preemption when a state law

“actually conflict[s] with federal law,” which can occur

when it is physically impossible to comply with both

federal and state law. State v. Diaz-Rey, 397 S.W.3d 5,

9 (Mo. App. E.D. 2013) (citing Arizona v. United

States, 567 U.S. 387, 399 (2012)). The “possibility of

impossibility [is] not enough” for the application of

conflict preemption. Carson, 92 F.4th at 997 (quoting

Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299,

314 (2019)) (bracketed alterations in original). In

order for conflict preemption to apply, there must be

an irreconcilable conflict between state and federal

law. Carson, 92 F.4th at 997; Paul v. Jackson, 910

S.W.2d 286, 292-93 (Mo. App. W.D. 1995). To show an

irreconcilable conflict that would bar Plaintiff’s failure

to warn claim, Monsanto has the burden of presenting

clear evidence that: (1) Monsanto fully informed the

EPA of the justifications for the warning that Missouri

5 Monsanto’s implied preemption arguments rely on, inter alia,

statutory provisions located within both FIFRA and Title 40 of

the Code of Federal Regulations.

App-9

law would impose; (2) the EPA informed Monsanto

that it would not approve changing the label to include

the warning; and (3) the EPA undertook its action

pursuant to authority that carries the force of law. See

Carson, 92 F.4th at 997 (citing Merck, 587 U.S. at 31316). The burden on a party attempting to use conflict

preemption as a defense is demanding. Carson, 92

F.4th at 997 (citing Wyeth v. Levine, 555 U.S. 555, 573

(2009)).

Monsanto has not met its demanding burden of

showing an irreconcilable conflict between state and

federal law in this case. See Carson, 92 F.4th at 997

(citing Merck, 587 U.S. at 313-16 and Wyeth, 555 U.S.

at 573). 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, and Monsanto does not specifically

make these arguments on appeal. See Carson, 92

F.4th at 997 (citing Merck, 587 U.S. at 313-16).

Instead, Monsanto argues the regulatory history of

glyphosate constitutes “clear evidence” the EPA would

not approve a cancer warning on Roundup’s label. In

support of this argument, Monsanto primarily points

to the EPA’s historical registration and re-registration

of Roundup labeling without a cancer warning, along

with the EPA’s conclusion that glyphosate is “not

likely to be carcinogenic to humans.” See footnote 1 of

this opinion.

However, the “possibility of impossibility [is] not

enough” for conflict preemption to apply. Carson, 92

F.4th at 997 (quoting Merck, 587 U.S. at 314)

(bracketed alterations in original). The EPA’s

App-10

historical approval of glyphosate labels without a

cancer warning and its past conclusions regarding

glyphosate’s carcinogenicity do not compel the

conclusion that the EPA would inevitably reject a

future label with a cancer warning. See Carson, 92

F.4th at 997. Said differently, we are not persuaded

that the EPA’s historical actions regarding glyphosate

constitute clear evidence of an irreconcilable conflict

between state and federal law, especially in light of

Monsanto’s demanding burden. See id. (citing Merck,

587 U.S. at 313-16 and Wyeth, 555 U.S. at 573); see

also Hardeman, 997 F.3d at 958-60 (similarly

holding). Accordingly, conflict preemption does not

impliedly preempt Plaintiff’s failure to warn claim in

this case. See id.; Paul, 910 S.W.2d at 292-93; see also

Diaz-Rey, 397 S.W.3d at 9 (citing Arizona, 567 U.S. at

399).

Monsanto’s Arguments on Appeal

In its arguments on appeal regarding express

preemption, Monsanto primarily relies upon

Schaffner v. Monsanto Corporation, 113 F.4th 364 (3rd

Cir. 2024), where the Third Circuit held that plaintiffs’

state law failure to warn claim against Monsanto was

expressly preempted by federal law. See id. at 370-99.

In doing so, Monsanto argues the decisions from two

other federal intermediate appellate courts—the

Eleventh and Ninth Circuits—and two state appellate

courts have “erroneously held” that express

preemption did not bar state law failure to warn

claims. See Carson, 92 F.4th at 986-96; Hardeman,

997 F.3d at 950-58; Johnson v. Monsanto Company,

554 P.3d 290, 295-98, 303-308 (Or. App. 2024); Pilliod

v. Monsanto Company, 282 Cal. Rptr. 3d 679, 688-702

App-11

(Cal. App. 2021). While the decisions of federal

intermediate appellate courts and other state courts

do not bind this Court, we do not find Schaffner

persuasive and choose to follow the weight of the

authority in holding that Plaintiff’s failure to warn

claim is not expressly preempted by federal law. See

Doe v. Roman Catholic Diocese of St. Louis, 311

S.W.3d 818, 823 (Mo. App. E.D. 2010) (citing, inter

alia, State v. Mack, 66 S.W.3d 706, 710 (Mo. banc

2002)).

Regarding implied preemption, Monsanto asks

this Court to follow holdings from three primary cases:

Mutual Pharmaceutical Co., Inc. v. Bartlett, 570 U.S.

472 (2013), PLIVA, Inc. v. Mensing, 564 U.S. 604

(2011), and Wyeth, 555 U.S. 555. However, we find

these cases distinguishable because they all involve

pharmaceutical products regulated under the Food,

Drug, and Cosmetic Act (“FDCA”), and we decline to

extend their holdings to pesticide products regulated

under FIFRA. See Bartlett, 570 U.S. at 476-78;

Mensing, 564 U.S. at 608-10, 612; Wyeth, 555 U.S. at

558-59, 566; see also Carson, 92 F.4th at 998 (similarly

distinguishing Mensing); Hardeman, 997 F.3d at 95859 (discussing at length how “FIFRA’s regulatory

regime for pesticides differs meaningfully from the

[FDCA] regulatory scheme,” in relevant part because

of the implications surrounding generic and namebrand drug manufacturers under the FDCA which do

not exist for pesticide manufacturers governed by

FIFRA).

App-12

C. Conclusion as to Monsanto’s Sole Point on

Appeal

Based on the foregoing, Plaintiff’s failure to warn

claim is not expressly or impliedly preempted by

federal law, and the trial court did not err in denying

Monsanto’s motion for JNOV. Monsanto’s sole point

on appeal is denied.

III. CONCLUSION

The trial court’s judgment entered upon the jury’s

verdict in favor of Plaintiff is affirmed.

[handwritten: signature]

ROBERT M. CLAYTON III,

Judge

App-13

Appendix C

MISSOURI CIRCUIT COURT

TWENTY-SECOND JUDICIAL CIRCUIT

________________

No. 1922-CC00221

________________

JOHN L. DURNELL, et al.,

Plaintiffs,

MONSANTO COMPANY, et al.,

Defendants.

________________

Filed: Sept. 28, 2023

________________

ORDER

________________

The Court has before it Defendant Monsanto

Company’s (Defendant’s) Motion for Summary

Judgment. The Court has reviewed the submissions of

the parties, the relevant authorities, and the

arguments of counsel, and now rules as follows.

Plaintiffs seek recovery for damages as a result of

Plaintiff John L. Durnell’s development of nonHodgkin’s lymphoma (NHL) allegedly caused by the

wrongful conduct of Defendants in connection with the

design,

development,

manufacture,

testing,

packaging, promoting, marketing, distribution, and/or

sale of the product known as Roundup. Plaintiffs claim

that Roundup and its active ingredient, glyphosate,

are unreasonably dangerous and defective.

App-14

Defendant argues that it is entitled to judgment

as a matter of law because Plaintiff’s claims are

expressly and impliedly preempted by the Federal

Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C.

§ 136 et seq., and because Plaintiff has not presented

admissible expert testimony to prove causation. In

addition, Defendant argues that Plaintiff lacks

evidence to support his punitive damages claim.

When ruling on a motion for summary judgment,

the Court must determine whether the moving party

has the “undisputed right to judgment as a matter of

law,” on the basis of the facts about which there is no

genuine dispute. ITT Commercial Fin. Corp. v. MidAmerica Marine Supply Corp., 854 S.W.2d 371, 380

(Mo. banc 1993). The party moving for summary

judgment bears the burden of establishing a right to

judgment as a matter of law. Id. at 378. Where the

movant is a defending party, the movant may

establish a right to judgment by showing facts that

negate any one of claimant’s elements’ facts, that the

non-movant after an adequate period of discovery has

not been able to produce or will not be able to produce

evidence sufficient to allow the trier of fact to find the

existence of any one of claimant’s elements, or that

there is no genuine dispute as to the existence of each

of the facts necessary to support the movant’s properly

pleaded affirmative defense. Id.

Once the moving party has met the burden

imposed by Rule 74.04(c) by establishing the right to

judgment, the non-movant’s only recourse is to show

by affidavit, depositions, answers to interrogatories,

or admissions on file, that one or more of the material

App-15

facts shown by movant is in fact genuinely disputed.

ITT, 854 S.W.2d at 381.

Federal law may preempt state law (1) where

Congress defines explicitly the extent to which its

enactments preempt state law; (2) in the absence of

explicit statutory authority, where the federal law

regulates conduct in a field that Congress intended for

the federal government to occupy exclusively; and

(3) to the extent that state law actually conflicts with

federal law. English v. General Electric, 496 U.S. 72,

78-79 (1990); See also Kurns v. R.R. Friction Prods.

Corp., 565 U.S. 625, 630 (2012), Wyeth v. Levine, 555

U.S. 555, 576, 571 (2009).

“Two prerequisites for allowing punitive damages

are (1) demonstrating some element of outrageous

conduct; and (2) showing the defendant acted with a

willful, wanton or malicious culpable mental state.”

Poage v. Crane Co., 523 S.W.3d 496, 515 (Mo. App.

E.D. 2017).

“Whether there is sufficient evidence for an award

of aggravating circumstances damages is a question of

law.” Clark v. SSM Healthcare St. Louis, 666 S.W.3d

at 221 (citing Brady v. Curators of Univ. of Missouri,

213 S.W.3d 101, 109 (Mo. App. E.D. 2006)). “However,

‘[i]n determining a summary judgment motion, the

judge ... is not to decide what the facts are or to make

credibility determinations, but simply to determine

whether there is a triable issue of fact.’” Id.

In this case, there is substantial dispute as to the

material facts relied on by Defendant. The Court

cannot “weigh conflicting evidence or make credibility

determinations” on summary judgment. Brentwood

Glass Co. v. Pal’s Glass Serv., 499 S.W.3d 296, 300

App-16

(Mo. bane 2016). The Court finds that Defendant has

not met its burden regarding its preemption

arguments given the disputed record and recognizing

existing precedent. The Court has denied in whole or

in part all of Defendant’s motions to exclude Plaintiff’s

expert testimony. The Court cannot determine from

the record before it that Plaintiff has not been able to

present admissible expert testimony to prove

causation. Finally, it appears from the record that

there is a triable issue of fact regarding Plaintiff’s

punitive damages claims. The Court cannot find that

Defendant has met its burden of showing the

undisputed right to judgment as a matter of law on the

basis of facts about which there is no genuine dispute.

Accordingly, the Court must deny Defendant’s

motion for summary judgment. This ruling is without

prejudice to Defendant to bring the same arguments

in a motion for directed verdict at the close of

Plaintiff’s case.

WHEREFORE, it is Ordered and Decreed that

Defendant Monsanto Company’s Motion for Summary

Judgment is DENIED.

[handwritten: signature]

Timothy Boyer, Judge

App-17

Appendix D

MISSOURI CIRCUIT COURT

TWENTY-SECOND JUDICIAL CIRCUIT

________________

No. 1922-CC00221

________________

JOHN L. DURNELL,

Plaintiff,

MONSANTO COMPANY,

Defendant.

________________

Filed: Oct. 17, 2023

________________

ORDER

________________

[handwritten: Comes now the Court, after

reviewing the brief and hearing the arguments of

counsel, and DENIES Monsanto Company’s Motion

for Directed Verdict at the Close of Plaintiff’s

Evidence.

SO ORDERED

Signature]

App-18

Appendix E

MISSOURI CIRCUIT COURT

TWENTY-SECOND JUDICIAL CIRCUIT

________________

No. 1922-CC00221

________________

JOHN L. DURNELL,

Plaintiff,

MONSANTO COMPANY,

Defendant.

________________

Filed: Oct. 19, 2023

________________

ORDER

________________

[handwritten: The plaintiffs are not pursuing

counts 4, 5, and 6, nor are they pursuing the theory of

negligent manufacture.

As to all other counts, Defendant Monsanto

Company’s Motion for Directed Verdict at the close of

all evidence is hereby DENIED.

SO ORDERED

Signature]

App-19

Appendix F

MISSOURI CIRCUIT COURT

TWENTY-SECOND JUDICIAL CIRCUIT

________________

No. 1922-CC00221

________________

JOHN L. DURNELL,

Plaintiff,

MONSANTO COMPANY,

Defendant.

________________

Filed: January 19, 2024

________________

ORDER AND JUDGMENT

________________

Comes now the Court and, after reviewing the

evidence presented and arguments of counsel, denies

Defendant’s Motion for Judgment Notwithstanding

the Verdict and in the Alternative for New Trial.

[handwritten: signature]

Timothy Boyer, Judge

App-20

Appendix G

MISSOURI CIRCUIT COURT

TWENTY-SECOND JUDICIAL CIRCUIT

________________

No. 1922-CC00221

________________

JOHN L. DURNELL,

Plaintiff,

MONSANTO COMPANY,

Defendant.

________________

Filed: June 24, 2024

________________

JUDGMENT

________________

The cause of Plaintiff John Durnell against

Defendant Monsanto Company was tried to a jury

from October 3, 2023 through October 20, 2023. The

jury returned a verdict as follows:

1. In favor of Defendant Monsanto Company on

Plaintiff John Durnell’s claim for compensatory

damages based on product defect;

2. In favor of Plaintiff John Durnell on

Plaintiff’s claim for compensatory damages based on

product defect–failure to warn;

3. In favor of Defendant Monsanto Company on

Plaintiff John Durnell’s claim for compensatory

damages based on negligence;

App-21

4. The jury assessed Plaintiff’s compensatory

damages at $1,250,000 (one million two hundred fifty

thousand dollars);

5. The jury found that Monsanto Company is

not liable for punitive damages.

Now therefore, it is ORDERED, ADJUDGED, and

DECREED as follows: In accordance with the verdict

of the jury set forth above, Plaintiff John Durnell shall

have and recover from Defendant Monsanto Company

the sum of $1,250,000 (one million two hundred fifty

thousand dollars) as and for compensatory damages,

together with post judgment interest as provided by

law.

Costs assessed against Defendant Monsanto

Company.

All matters and things and controversy as

between Plaintiff John Durnell and Defendant

Monsanto Company having been resolved by the

aforementioned jury verdict, pursuant to S.Ct. Rule

74.01(b) of the Missouri Rules of Civil Procedure, this

Court finds that this Judgment, and each Part thereof,

be, and hereby is, certified as final for purposes of

appeal and that there is no just reason for delay.

SO ORDERED:

[handwritten: signature]

Timothy J. Boyer

Circuit Judge

Division 8

App-22

Appendix H

United States Environmental Protection

Agency Memorandum re: Withdrawal of the

Glyphosate Interim Registration Review

Decision (Sept. 21, 2022)

On June 17, 2022, the United States Court of

Appeals for the Ninth Circuit vacated and remanded

the human health portion of EPA’s interim

registration review decision for glyphosate (ID), held

that EPA’s failure to make an effects determination

before issuing the ID violated the Endangered Species

Act (ESA), and remanded without vacating the

ecological portion of the ID but imposed an October 1,

2022 deadline for EPA to complete the remand.

Natural Resources Defense Council et al. v. EPA, 38

F.4th 34 (9th Cir. 2022). In light of the court’s decision,

this memorandum announces EPA’s withdrawal of all

remaining portions of the glyphosate ID, including the

remanded ecological portion.

A copy of the glyphosate ID, now vacated in part

and the remainder withdrawn, is posted to the

glyphosate registration review public docket (EPAHQ-OPP-2009-0361) at https://www.regulations.gov.

Background

Issuance of the Glyphosate Interim Registration

Review Decision

Registration review is EPA’s periodic review of

pesticide registrations to ensure that each pesticide

registration continues to satisfy the Federal

Insecticide, Fungicide, and Rodenticide Act (FIFRA)

standard for registration, that is, that the pesticide

can perform its intended function without

App-23

unreasonable adverse effects on human health or the

environment. Under FIFRA section 3(g), each

pesticide is required to be reviewed every 15 years.

EPA regulations establish procedures for the

registration review program required in FIFRA

section 3(g). Under 40 C.F.R. § 155.56, EPA may issue,

when it determines it to be appropriate, an interim

registration review decision before completing a

registration review. Among other things, the interim

registration review decision may require new risk

mitigation measures, impose interim risk mitigation

measures, identify data or information required to

complete the review, and include schedules for

submitting the required data, conducting the new risk

assessment, and completing the registration review.

Procedures for issuing an interim registration review

decision are set forth in § 155.58.

On February 3, 2020, EPA published a notice in

the Federal Register (85 Fed. Reg. 5957) announcing

the availability of the glyphosate ID. EPA issued the

ID pursuant to 40 C.F.R. §§ 155.56 and 155.58,

explaining that it was doing so to “(1) move forward

with aspects of the registration review case that are

complete and (2) implement interim risk mitigation.”

The ID finalized EPA’s draft risk assessments

supporting registration review, Glyphosate Draft

Human Health Risk Assessment for Registration

Review and Registration Review—Preliminary

Ecological Risk Assessment for Glyphosate and Its

Salts. The ID did not identify any human health risks

of concern from exposure to glyphosate but did identify

potential ecological risks. It also identified interim

risk mitigation measures, in the form of label changes,

App-24

including spray drift management language, herbicide

resistance management language, a non-target

organism advisory, and certain label consistency

measures. It concluded that, under FIFRA, the

benefits of glyphosate outweigh the potential

ecological risks when glyphosate is used in accordance

with labels.

The glyphosate ID did not make findings under

section 7 of the ESA or under the Endocrine Disruptor

Screening Program (EDSP) pursuant to section 408(p)

of the Federal Food, Drug, and Cosmetic Act (FFDCA),

nor did it respond to a 2018 administrative petition

submitted by the Environmental Working Group and

others (EWG et al.) to reduce the tolerance level for

glyphosate residues on oats and require certain label

changes based on concerns regarding dietary exposure

and carcinogenicity. EPA explained that it would do so

before completing registration review for glyphosate,

and that the “final registration review decision for

glyphosate will be dependent upon the result of the

agency’s ESA assessment and any needed section 7

consultation with the [U.S. Fish and Wildlife Service

and the National Marine Fisheries Service], an EDSP

FFDCA section 408(p) determination, and after a

resolution of the EWG et al. petition.” The glyphosate

ID also did not solicit label changes from registrants

to implement the interim risk mitigation measures.

EPA explained that it would do so once it responded to

the EWG et al. petition.

For further background on glyphosate and its

registration review history, see the end of this

memorandum.

App-25

Endangered Species Act Assessment for Glyphosate

ESA section 7(a)(2) requires that federal agencies

ensure that the actions they authorize, fund, or carry

out are not likely to jeopardize the continued existence

of species listed as threatened or endangered under

the ESA (listed species) or destroy or adversely modify

their designated critical habitat. For pesticides in

registration review, EPA’s responsibility includes

evaluating potential effects to listed species and their

designated critical habitat, often through a biological

evaluation (BE). If EPA determines that a pesticide’s

registration “may affect” and is “likely to adversely

affect” listed species or designated critical habitat, the

Agency initiates formal consultation with the U.S.

Fish and Wildlife Service (FWS) and/or the National

Marine Fisheries Service (NMFS) (together, the

Services). The Services prepare their respective

biological opinions (BiOps) regarding whether the

pesticide’s registration is likely to jeopardize the

continued existence of listed species or result in the

destruction or adverse modification of designated

critical habitats and describing any reasonable and

prudent measures or reasonable and prudent

alternatives. EPA then uses its authorities under

FIFRA to implement, as necessary, any such

measures or alternatives described in the BiOps.

On November 25, 2020, EPA released the draft

BE for glyphosate for public comment. On November

12, 2021, EPA released the final BE for glyphosate,

which found that glyphosate may affect 1,795 listed

species and 792 critical habitats and is likely to

adversely affect 1,676 of those species and 759 of those

habitats. EPA initiated formal consultation with the

App-26

Services in November 2021. As noted in the

declaration filed in support of EPA’s August 1, 2022

petition for panel rehearing of the Ninth Circuit’s

decision, discussed below, consultation with the

Services is ongoing.

For further information on EPA’s ESA

assessment for glyphosate, see https://www.epa.gov/

endangered-species/final-national-level-listedspecies-biologicalevaluation-glyphosate.

Challenges to Glyphosate Interim Registration Review

Decision

On March 20, 2020, two groups of petitioners filed

petitions for review of the glyphosate ID in the Ninth

Circuit. See Natural Resources Defense Council et al.

v. EPA, No. 20-70787 and Rural Coalition et al. v.

EPA, No. 20-70801. Together these petitions

challenged EPA’s analysis of the human health and

ecological risks and costs of glyphosate, weighing of

such risks against the benefits of glyphosate, and the

interim risk mitigation measures identified in the ID,

and alleged that EPA violated the ESA by issuing the

ID before completing consultation with the Services.

While EPA defended its analysis of human health

risks and the alleged ESA violation, it moved for

partial voluntary remand without vacatur of its

analysis of ecological risks and costs, weighing of such

risks against benefits, and interim risk mitigation

measures. EPA sought remand to:



Consider how the glyphosate ID may be

impacted by the (then) draft BE and whether

additional or different risk mitigation

measures may be necessary.

App-27



Reconsider its analysis of ecological risks as it

relates to in-field effects of glyphosate on

monarch butterfly habitat in light of the court

decision in National Family Farm Coalition v.

EPA, 966 F.3d 893 (9th Cir. 2020).



Consider whether the court decision in

National Family Farm Coalition v. EPA, 960

F.3d 1120 (9th Cir. 2020) regarding EPA’s

analysis of spray drift risks and other potential

costs of another pesticide (dicamba) affected

EPA’s analysis of glyphosate.



Evaluate the glyphosate ID in light of the

change in Administration and policy priorities,

as reflected in the January 20, 2021 “Executive

Order on Protecting Public Health and the

Environment and Restoring Science to Tackle

the Climate Crisis” (86 FR 7037, 1/25/21) and,

in particular, consider whether there are other

aspects of its analysis of ecological risks and

costs related to glyphosate that should be

reassessed or for which additional explanation

should be provided.



Consider what risk mitigation measures may

be necessary to reduce potential risks

following completion of analyses left

outstanding in the ID.

The Ninth Circuit heard oral argument on these

challenges on January 10, 2022 and issued its decision

on June 17, 2022. The court vacated and remanded the

human health portion of the glyphosate ID, held that

EPA’s failure to make an effects determination before

issuing the ID violated the ESA, and granted EPA’s

motion for partial voluntary remand but imposed an

App-28

October 1, 2022 deadline for EPA “to issue a new

ecological portion.” Natural Resources Defense Council

et al. v. EPA, 38 F.4th 34 (9th Cir. 2022).

On August 1, 2022, EPA filed a petition for panel

rehearing that sought relief only from the court’s

imposition of a deadline to complete remand of the

ecological portion of the ID. EPA explained that, while

the court did not define what it meant by “issue a new

ecological portion,” the Agency would not be able to

finalize a new ecological portion in a registration

review decision for glyphosate by the October 1, 2022

deadline because of the time needed to address the

issues for which EPA sought remand and to complete

consultation under the ESA. In a declaration filed in

support of the petition, EPA set forth its anticipated

schedule for completing registration review for

glyphosate. EPA also stated that if the court did not

lift the deadline, the Agency might exercise its

discretion to withdraw the remanded ecological

portion of the ID and focus its efforts on the required

final registration review decision for glyphosate. A

copy of EPA’s August 1, 2022 petition for panel

rehearing and declaration filed in support of the

petition is posted to the glyphosate registration review

public

docket

(EPA-HQ-OPP-2009-0361)

https://www.regulations.gov.

On August 5, 2022, the court denied EPA’s

petition for panel rehearing without opinion.

Withdrawal

In its June 17, 2022 decision, the Ninth Circuit

vacated and remanded the human health portion of

the glyphosate ID. EPA is now withdrawing all

remaining portions of the ID, including the remanded

App-29

ecological portion consisting of the Agency’s analysis

of the ecological risks and costs of glyphosate, the

weighing of such risks against the benefits of

glyphosate, and interim risk mitigation measures.

Because the ID is an informal adjudication that EPA

issued at its discretion, EPA may withdraw all or a

portion of it without public comment. Moreover, it

would be impracticable for EPA to take public

comment here because of the October 1, 2022 deadline

imposed by the court to complete remand of the

ecological portion of the ID.

EPA has determined that withdrawal is

appropriate in light of the Ninth Circuit’s June 17,

2022 decision and the particular circumstances of

glyphosate’s registration review and ESA assessment.

Insofar as the court has ordered EPA to finalize a “new

ecological portion,” doing so through another interim

registration review decision or a final registration

review decision would involve significant and lengthy

steps. As detailed in EPA’s August 1, 2022 petition for

panel rehearing and declaration filed in support of the

petition, the Agency is unable to finalize a new

ecological portion in a registration review decision for

glyphosate by the court-imposed October 1, 2022

deadline because of the time needed to address the

issues for which EPA sought remand and to complete

consultation under ESA. Moreover, before issuing

such a decision, EPA must first prepare a proposed

decision, make it available for a period of public

comment of at least 60 days, and consider any

comments received. 40 C.F.R. § 155.58. For reference,

EPA received approximately 283,300 public comments

comprising over 12,000 unique submissions when it

published the glyphosate proposed ID in May 2019,

App-30

and it then took nine months to finalize and publish

the ID in February 2020. EPA cannot complete these

processes by the court-imposed October 1, 2022

deadline.

To date, EPA has not solicited label changes from

registrants to implement the interim risk mitigation

measures identified in the ID. The Agency has not

solicited such label changes because EPA’s continued

work towards completing registration review for

glyphosate could affect what risk mitigation measures

EPA may determine are necessary, as noted in the

declaration filed in support of EPA’s August 1, 2022

petition for panel rehearing of the Ninth Circuit’s

decision. Moreover, the Agency continues to work on a

response to the EWG et al. petition, which asks EPA

to reduce the tolerance level for glyphosate residues

on oats and require certain label changes based on

concerns

regarding

dietary

exposure

and

carcinogenicity. Because of the court’s vacatur and

remand of the human health portion of the ID, EPA

believes it would be appropriate to respond to the

EWG et al. petition once it completes its review on

remand. To avoid multiple, and potentially conflicting,

rounds of label changes, EPA expects to defer

solicitation of label changes until it issues a final

registration review decision for glyphosate.

For these reasons, EPA believes it is appropriate

to withdraw all remaining portions of the glyphosate

ID, including the remanded ecological portion, and

focus its efforts on completing the required final

registration review decision for glyphosate.

Although the glyphosate ID is now vacated in part

and the remainder withdrawn, that does not

App-31

automatically mean that EPA’s underlying scientific

findings regarding glyphosate, including its finding

that glyphosate is not likely to be carcinogenic to

humans, are either incorrect or cannot be used as

support for a future decision following reconsideration

in accordance with the court’s decision.

Next Steps

With respect to the vacated human health portion

of the ID, in accordance with the Ninth Circuit’s June

17, 2022 decision, EPA intends to revisit and better

explain its evaluation of the carcinogenic potential of

glyphosate and to consider whether to do so for other

aspects of its human health analysis. With respect to

the withdrawn ecological portion of the ID, EPA

intends to address the issues for which it sought

remand, including:



Consider whether additional or different risk

mitigation measures may be necessary based

on the outcome of ESA consultation for

glyphosate.



Prepare an analysis of in-field effects of

glyphosate on monarch butterfly habitat. •

Consider whether EPA’s analysis of spray drift

risks and other potential costs of dicamba are

relevant to EPA’s analysis of glyphosate’s risk

from spray drift.



Consider whether there are other aspects of

EPA’s analysis of ecological risks and costs

related to glyphosate that should be

reassessed or for which additional explanation

should be provided.

App-32



Consider what risk mitigation measures may

be necessary to reduce potential risks

following completion of analyses left

outstanding in the ID.

EPA also intends to complete ESA consultation with

the Services, respond to the EWG et al. petition, and

make an FFDCA section 408(p) EDSP determination

before issuing a final registration review decision for

glyphosate. As noted in the declaration filed in support

of EPA’s August 1, 2022 petition for panel rehearing

of the Ninth Circuit’s decision, EPA anticipates

issuing a final registration review decision for

glyphosate in 2026.

Glyphosate Background

Review History

and

Registration

Glyphosate is a non-selective, systemic herbicide

with products registered for use in a wide array of both

agricultural

and

non-agricultural

settings.

Agricultural uses include stone and pome fruits, citrus

fruits, berries, nuts, vegetables, cereal grains, and

other field crops. Non-agricultural uses include

residential spot treatments, aquatic areas, forests,

rights-of-way, recreational turf, ornamentals, nonfood tree crops, and Conservation Reserve Program

land. Glyphosate products are also registered for use

on the glyphosate-resistant crops, including alfalfa,

corn, soybean, cotton, canola, and sugar beets.

EPA formally initiated registration review for

glyphosate in 2009 with the opening of the registration

review docket for the case. The following summary

highlights significant milestones that have occurred

during the registration review of glyphosate

App-33



July 2009 - The Glyphosate Preliminary Work

Plan (PWP), the Glyphosate Human-Health

Assessment Scoping Document in Support of

Registration Review, and the Registration

Review–Preliminary Problem Formulation for

the Ecological Risk and Drinking Water

Exposure Assessments for Glyphosate and Its

Salts were posted to the docket for a 60-day

public comment period.



December 2009 - The Glyphosate Final Work

Plan (FWP) was issued. Comments received on

the PWP covered the following topics:

opposition to the use of glyphosate, the toxicity

of glyphosate formulations and inert

ingredients, use and usage trends, human

health risks, ecological risks, endocrine

disruption, and the benefits of glyphosate. The

public comments received did not change the

schedule,

risk

assessment

needs,

anticipated data requirements in the FWP.



September 2010 - A Generic Data Call-In

(GDCI) for glyphosate was issued for data

needed to conduct the registration review risk

assessments. All required data were submitted

and reviewed. The registration review GDCI

for glyphosate is considered satisfied.



September 2015 - The Agency completed its

evaluation of Tier 1 endocrine data submitted

under the EDSP and published the

Glyphosate: Weight of Evidence Analysis of

Potential Interaction with the Estrogen,

Androgen, or Thyroid Pathways. EPA found no

convincing evidence of potential interaction

App-34

with the estrogen, androgen, or thyroid

pathways

and

glyphosate

was

not

recommended for further EDSP testing.



December 2016 - The agency convened a

FIFRA Scientific Advisory Panel meeting to

consider and review a set of scientific issues

related to the EPA’s evaluation of the

carcinogenic potential of glyphosate. The

meeting agenda, the agency’s cancer issue

paper, charge questions for the panel,

transcript, and final report are available on

EPA’s

website:

https://www.epa.gov/sap/

meetingmaterials-december-13-16-2016scientific-advisory-panel.

Additional

supporting materials and comments received

from the public can be found in docket

EPAHQ-OPP-2016-0385

www.regulations.gov.



December 2017 - The agency published the

Revised Glyphosate Issue Paper: Evaluation of

Carcinogenic Potential (dated December 12,

2017), the Response to the Final Report of the

Federal

Insecticide,

Fungicide,

and

Rodenticide Act Scientific Advisory Panel

(FIFRA SAP) on the Evaluation of the Human

Carcinogenic Potential of Glyphosate (dated

December 12, 2017), the Glyphosate Draft

Human

Health

Risk

Assessment

for

Registration Review (dated December 12,

2017), and the Registration Review –

Preliminary Ecological Risk Assessment for

Glyphosate and its Salts (dated September 8,

2015) on EPA’s website: https://www.epa.gov/

App-35

ingredients-used-pesticide-products/drafthuman-health-andecological-riskassessments-glyphosate.



February 2018 - The agency announced the

availability of the human health and ecological

risk assessments for a 60-day public comment

period. Over 238,000 comments were received

during the comment period, most of which

came from various mass mail campaigns.

Approximately 2,244 unique submissions were

received from various stakeholders, including

pesticide

registrants,

industry

groups,

farmers, grower groups, private citizens, nongovernmental organizations, states, and the

U.S. Department of Agriculture. The

comments did not change the risk assessments

or registration review timeline for glyphosate.



September 2018 - The Environmental Working

Group, joined by Ben & Jerry’s Homemade,

Inc., Happy Family Organics, MegaFood,

MOM’s Organic Market, National Co+op

Grocers, Nature’s Path Foods Inc., One Degree

Organic Foods USA, Inc., and Stonyfield

Farm, Inc. submitted an administrative

petition to the Agency. The petition requested

that EPA lower the tolerance for residues of

glyphosate on oats and require label changes

to prohibit the preharvest use of glyphosate on

oats. On May 6, 2019, the Agency published a

Notice of Filing of the petition in the Federal

docket EPA-HQ-OPP-2019-0066. 103,447

comments were received on the petition, most

App-36

of which came from mass mail campaigns and

419 of which represented unique comments.

The Agency continues to work on its response

to the petition.



May 2019 - The Agency announced the

availability of the Glyphosate Proposed

Interim Registration Review Decision (PID) for

a 60-day public comment period, which was

later extended to 120 days. Along with the

PID, the following documents were posted to

the docket:

o Glyphosate: Response to Comments,

Usage, and Benefits (dated April 18, 2018)

o Glyphosate: Response to Comments on the

Human Health Draft Risk Assessment

(dated April 23, 2019)

o Response to Public Comments on the

Preliminary Ecological Risk Assessment

for Glyphosate (dated November 21, 2018)

During the 120-day comment period on the PID,

the agency received roughly 283,300 comments. Over

12,000 unique submissions were received from various

stakeholders, including glyphosate registrants,

grower groups, non-governmental organizations,

pesticide industry groups, states, the U.S.

Department of Agriculture and members of the

general public. Most comments came from mass

mailer campaigns, and approximately 120 unique

substantive comments were received from various

stakeholders. Public comments did not change the

Agency’s risk conclusions but resulted in changes to

the spray drift management labeling and rotational

crop instructions.

App-37



February 2020 - The Agency announced the

availability of the ID. Along with the ID, the

following documents were published in the

docket:

o Response

from

the

Pesticide

Reevaluation Division to Comments

on the Glyphosate Proposed Interim

Decision (dated January 16, 2020)

o Glyphosate Response to Comments

on the Proposed Interim Decision

Regarding the Human Health Risk

Assessment (dated January 13, 2019)

o Glyphosate: Epidemiological Review

of Zhang et al. (2019) and Leon et al.

(2019) publications for Response to

Comments on the Proposed Interim

Decision (dated January 6, 2020)



November 2020 - The Agency released the

draft BE for glyphosate for public comment.

Approximately 870 comments that pertained

to the draft BE for glyphosate were submitted,

including 11 requests for extensions of the

public comment period. Additionally, six mass

mail campaigns were submitted with

approximately 110,000 signatures.



November 2021 - The Agency released the

final BE for glyphosate evaluating potential

effects to listed species and critical habitats.

App-38

Appendix I

Letter from United States Environmental

Protection Agency re: Glyphosate (Aug. 7, 2019)

Dear Registrant,

We are writing to you concerning label and

labeling requirements for products that contain

glyphosate.

On July 7, 2017, California listed glyphosate as a

substance under Proposition 651, based on the

International Agency for Research on Cancer’s

(IARC’s) classification of the pesticide as “probably

carcinogenic to humans.” EPA disagrees with IARC’s

assessment of glyphosate. EPA scientists have

performed an independent evaluation of available

data since the IARC classification to reexamine the

carcinogenic potential of glyphosate and concluded

that glyphosate is “not likely to be carcinogenic to

humans.” EPA considered a more extensive dataset

than IARC, including studies submitted to support

registration of glyphosate and studies identified by

EPA in the open literature as part of a systematic

review. For more detailed information on this

evaluation, please see the 2017 Revised Glyphosate

1 California’s Safe Drinking Water and Toxic Enforcement Act

of 1986 (also known as Proposition 65) requires businesses to

inform Californians about significant exposures 10 chemicals

that, under the terms of Proposition 65, are believed to cause

cancer, birth defects or other reproductive harm. See California

Office of Environmental Health Hazard Assessment,

“Proposition 65,” at https://oehha.ca.gov/proposition-65.

App-39

Issue Paper: Evaluation of Carcinogenic Potential2.

Further, EPA’s cancer classification is consistent with

other international expert panels and regulatory

authorities,

including

the

Canadian

Pest

Management Regulatory Agency, Australian Pesticide

and Veterinary Medicines Authority, European Food

Safety Authority, European Chemicals Agency,

German Federal Institute for Occupational Safety and

Health, New Zealand Environmental Protection

Authority, and the Food Safety Commission of Japan.

On February 26, 2018, the United States District

Court for the Eastern District of California issued a

preliminary injunction enjoining California from

enforcing the state warning requirements involving

the pesticide glyphosate’s carcinogenicity, in part on

the basis that the required warning statement is false

or misleading3.

Given EPA’s determination that glyphosate is

“not likely to be carcinogenic to humans,” EPA

considers the Proposition 65 warning language based

on the chemical glyphosate to constitute a false and

misleading statement. As such, pesticide products

bearing the Proposition 65 warning statement due to

the presence of glyphosate are misbranded pursuant

to section 2(q)(1)(A) of FIFRA and as such do not meet

the requirements of FIFRA. In registering pesticides,

EPA must determine that the labeling complies with

the requirements of FIFRA including that the product

2 hnps:www.regulauons.gov/document?D=EPA-HO-OPP-2009-0361-0073

3 National Association of Wheat Growers, et al. v. Zeise, 309

F.Supp.3d 842 (E.D.Cal.)

App-40

not be misbranded. See FIFRA (3)(c)(5)(B). Therefore,

EPA will no longer approve labeling that includes the

Proposition 65 warning statement for glyphosatecontaining products. The warning statement must

also be removed from all product labels where the only

basis for the warning is glyphosate, and from any

materials considered labeling under FIFRA for those

products.

For any pesticide product that currently contains

Proposition 65 warning language exclusively on the

basis that it contains glyphosate, EPA requests the

submission of draft amended labeling that removes

such language within ninety (90) days of the date of

this letter.

Sincerely,

[handwritten: signature]

Michael L. Goodis, P.E.

Director, Registration Division

Office of Pesticide Programs

App-41

Appendix J

Letter from United States Environmental

Protection Agency to Lauren Zeise, Office

of Environmental Health Hazard Assessment,

California Environmental Protection

Agency (Apr. 8, 2022)

Dear Dr. Zeise:

Thank you for your letter of March 21, 2022, to the

U.S. Environmental Protection Agency (EPA)

regarding glyphosate and California’s Safe Drinking

Water and Toxics Enforcement Act of 1986, also

known as Proposition 65.

Your letter proposes a revision to previously

proposed safe harbor language that businesses could

use to satisfy California’s notification requirements

for certain glyphosate products under Proposition 65.

It further requested that EPA provide input on

whether the newly proposed language could be

approved, if requested by a pesticide registrant, for

inclusion on pesticide labels for products containing

glyphosate as an active ingredient and sold in

California. As explained below, EPA could approve the

newly proposed language.

The Agency continues to stand behind its robust

scientific evaluation of the carcinogenic potential of

glyphosate. Furthermore, EPA’s conclusion remains

consistent with many international expert panels and

regulatory authorities (https://www.regulations.gov/

document/EPA-HQ-OPP-2009-0361-0073).

Nonetheless, EPA recognizes that the revised safe

harbor language proposed by the Office of

Environmental Health Hazard Assessment (OEHHA)

App-42

acknowledges the EPA position: CALIFORNIA

PROPOSITION 65 WARNING: Using this product

can expose you to glyphosate. The International

Agency for Research on Cancer 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

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.

The letter from OEHHA further requests that

EPA clarify its position as previously stated in its

August 7, 2019, letter to registrants regarding

products that contain glyphosate. That 2019 letter

focused on the application of the default Proposition

65 safe harbor warning language to products

containing glyphosate and advised that EPA would no

longer approve glyphosate labeling containing that

statement because it was in conflict with the Agency’s

scientific conclusions regarding glyphosate. The

Agency concluded that the standard warning

language for products containing glyphosate was false

or misleading and therefore, any glyphosate products

bearing the statement would be considered

misbranded.

While EPA’s scientific conclusions regarding the

glyphosate cancer classification have not changed

since the August 7, 2019, letter to glyphosate

registrants, it has determined that the new

glyphosate-specific safe harbor language proposed in

OEHHA’s recent letter is sufficiently clear regarding

App-43

EPA’s position and thus would not be considered false

and misleading. Therefore, this revised language

could be approved by EPA if pesticide registrants

requested it for inclusion on glyphosate product labels,

and the products would not be considered misbranded.

As stated in OEHHA’s letter, EPA notes that inclusion

on the product label is one of several methods that

companies can use to satisfy California’s notification

requirements under Proposition 65.

EPA appreciates the constructive approach that

California is pursuing to address this matter and looks

forward to further strengthening our relationships

with our stakeholders as we forge ahead together in

our work. We thank you for taking the time to write

on this important matter.

Sincerely,

Michal Freedhoff, Ph.D

Assistant Administrator

App-44

Appendix K

RELEVANT STATUTORY PROVISION

7 U.S.C. §136v(a)-(b)

(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 this subchapter.

(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 this

subchapter.

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.