Respondents Brief — Monsanto Company, Petitioner v. John L. Durnell
Supreme Court briefMar 25, 2026
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No. 24-1068
In the Supreme Court of the United States
_____________
MONSANTO COMPANY, PETITIONER
v.
JOHN L. DURNELL, RESPONDENT
_____________
ON WRIT OF CERTIORARI
TO THE MISSOURI COURT OF APPEALS
_____________
BRIEF FOR THE RESPONDENT
_____________
JONATHAN F. MITCHELL
Mitchell Law PLLC
111 Congress Avenue
Suite 400
Austin, Texas 78701
(512) 686-3940
jonathan@mitchell.law
T. ROE FRAZER II
THOMAS ROE FRAZER III
JAMES GRANT LABAR
R. PRESCOTT SIFTON JR.
Frazer PLC
30 Burton Hills Boulevard
Suite 450
Nashville, Tennessee 37215
(615) 647-6464
ASHLEY C. KELLER
Counsel of Record
JOHN JAMES SNIDOW
Keller Postman LLC
1101 Connecticut Avenue NW
Suite 1100
Washington, D.C. 20036
(202) 918-1123
ack@kellerpostman.com
JAMES G. ONDER
W. WYLIE BLAIR
GREGORY J. PALS
MARK E. BERNS
OnderLaw LLC
110 East Lockwood Avenue
St. Louis, Missouri 63119
(314) 963-9000
Counsel for the Respondent
QUESTIONS PRESENTED
The Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) prohibits the sale or distribution of a pesticide that is “not registered” with EPA. 7 U.S.C.
§ 136j(a)(1)(A). FIFRA delegates to EPA significant powers in the registration process. EPA is required to make
various determinations, including whether a pesticide’s
label complies with FIFRA. 7 U.S.C. § 136a(c)(5)(B).
Those determinations control only whether EPA “shall
register” the pesticide. They do not impose new statutory
requirements for labeling.
FIFRA imposes an independent prohibition on the
sale or distribution of any “misbranded” pesticide. 7
U.S.C. § 136j(a)(1)(E). A pesticide can be misbranded because its label is inadequate. 7 U.S.C. § 136(q)(1)(A), (G).
Unlike the registration requirement, the misbranding
prohibition does not vest EPA with any delegated authority to interpret or implement the statutory ban on selling
or distributing misbranded products. And FIFRA explicitly states that compliance with FIFRA’s registration requirements is no defense when a pesticide manufacturer
is sued for selling or distributing a misbranded product.
See 7 U.S.C. § 136a(f)(2) (“In no event shall registration of
an article be construed as a defense for the commission of
any offense under this subchapter.”).
Respondent John Durnell contracted cancer after using Roundup and sued Monsanto for failing to warn him
of the risks. Monsanto claims that Durnell’s failure-towarn claim is preempted under 7 U.S.C. § 136v(b), which
displaces state-law labeling requirements that are “in addition to or different from” those required by FIFRA.
Durnell claims that Missouri failure-to-warn law imposes
(i)
the same requirements as FIFRA’s textual prohibition on
selling a misbranded pesticide. Monsanto relies not on
FIFRA’s text, but EPA’s registration decision to argue a
difference between Missouri and federal law. So Monsanto
must believe that section 136a(c)(5) vests EPA with Chevron-like powers to interpret the ultimate meaning of the
statutory “misbranding” prohibition in a manner that
binds the judiciary. The questions presented are:
1. Is Durnell’s failure-to-warn claim expressly
preempted on the ground that Missouri law imposes labeling requirements that add to or differ from the misbranding provisions in FIFRA?
2. Is Durnell’s failure-to-warn claim impossibility preempted on the ground that federal law requires Monsanto to use the Roundup labeling
that Missouri law deems misleading or inadequate?
(ii)
PARTIES TO THE PROCEEDING
Petitioner Monsanto Company was the appellant in
the Missouri Court of Appeals. Respondent John L. Durnell was the appellee.
Monsanto’s stock-ticker symbol was MON, which
traded on the New York Stock Exchange (NYSE) until
June 7, 2018. On that date, Monsanto was acquired by
Bayer and subsequently delisted, and its operations were
integrated into Bayer’s Crop Science division. Bayer AG’s
primary stock-ticker symbol in the United States is
BAYRY, which represents its American Depositary Receipt (ADR) traded on the OTCQX market in USD. In its
home market (Germany), the stock trades on the XETRA
exchange under the ticker BAYN.
(iii)
TABLE OF CONTENTS
Questions presented ............................................................. i
Parties to the proceeding ................................................... iii
Table of contents ................................................................. iv
Table of authorities ............................................................ vii
Statutory provisions involved ..............................................7
Statement ...............................................................................7
I. Statutory and regulatory background ...................7
A. Federal law...........................................................7
1. Registration ................................................... 7
2. Misbranding................................................... 9
3. Post-registration changes to labels........... 11
4. Express preemption ................................... 11
B. Missouri law .......................................................12
II. Procedural history ..................................................14
A. History of Roundup litigation .........................14
B. History of this suit ............................................15
Summary of argument........................................................16
Argument .............................................................................19
I. Durnell’s failure-to-warn claim is not
expressly preempted ..............................................19
A. Missouri tort law does not add to or differ
from
FIFRA’s
adequate-warning
requirement .......................................................20
1. FIFRA delegates to the judiciary and
not EPA the power to determine
whether Roundup is misbranded .............. 21
2. FIFRA’s provisions show that EPA’s
decision to register a pesticide does
not preclude courts from finding that
pesticide misbranded .................................. 28
(iv)
3. Missouri’s warning requirements do
not add to or differ from FIFRA’s
misbranding provisions .............................. 33
B. Even if Monsanto could show that
Missouri tort law adds to or differs from
FIFRA,
Monsanto
forfeited
this
argument by failing to ask for a Bates
instruction at trial .............................................34
II. Durnell’s failure-to-warn claim is not
impliedly preempted ...............................................36
A. Neither FIFRA nor its implementing
regulations prevent Monsanto from
adding a cancer warning to Roundup’s
labeling ...............................................................37
1. 7 U.S.C. § 136j(a)(1)(B) prevents
manufacturers from altering the
statement of claims made for a
pesticide, not its labeling ............................ 38
2. EPA’s regulations do not and cannot
prevent Monsanto from adding a
cancer warning to Roundup’s labeling ..... 39
B. Durnell’s claim is not preempted even if
Monsanto could not change the label .............43
III.Monsanto’s preemption arguments find no
support in this court’s case law .............................46
A. Monsanto’s preemption arguments are
incompatible with Bates ...................................46
B. The Court’s decision in Riegel v.
Medtronic, Inc. is inapposite ...........................49
Conclusion ............................................................................52
Appendix ..................................................................................
7 U.S.C. § 136(q) .................................................................. 1a
(v)
7 U.S.C. § 136(bb) ................................................................ 4a
7 U.S.C. § 136a ..................................................................... 5a
7 U.S.C. § 136j(a)(1) .......................................................... 40a
7 U.S.C. § 136v(a)–(b) ....................................................... 44a
7 U.S.C. § 136w(a)–(c) ....................................................... 45a
40 C.F.R. § 152.44 .............................................................. 49a
40 C.F.R. § 152.46 .............................................................. 51a
Pesticide (PR) Notice 95-2 ............................................... 53a
Pesticide (PR) Notice 98-10 ............................................. 73a
Pesticide (PR) Notice 2000-15 ....................................... 103a
Letter from Larry R. Hodges, Bayer CropScience, to EPA, Office of Pesticide Programs
(Nov. 29, 2012) ............................................................ 113a
Letter from Jennifer Gaines, EPA, Office of
Pesticide Programs, to Larry Hodges, Bayer
CropScience (Dec. 17, 2012) ..................................... 115a
(vi)
TABLE OF AUTHORITIES
Cases
B&B Hardware, Inc. v. Hargis Industries, Inc.,
575 U.S. 138 (2015) ..........................................................29
Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) .........
2, 3, 4, 10, 10–11, 12, 16, 18, 31, 33, 34, 44, 45, 46, 48, 49, 50
English v. General Electric Co., 496 U.S. 72 (1990) ........34
Epic Systems Corp. v. Lewis, 584 U.S. 497 (2018) ..........25
Haberly v. Reardon Co.,
319 S.W.2d 859 (Mo. 1958) ........................................12, 33
La Plant v. E.I. DuPont De Nemours & Co.,
346 S.W.2d 231 (Mo. Ct. App. 1961) ........................12, 33
Loper Bright Enterprises v. Raimondo,
603 U.S. 369 (2024) ..................5, 10, 11, 21, 22, 24, 25, 26
Marbury v. Madison, 1 Cranch 137 (1803) ......................24
Meeker v. Lehigh Valley R. Co., 236 U.S. 412 (1915) ......30
Merck Sharp & Dohme Corp. v. Albrecht,
587 U.S. 299 (2019) ..........................................3, 36, 42, 43
Moore v. Ford Motor Co.,
332 S.W.3d 749 (Mo. 2011) ....................................3, 12, 13
Mutual Pharmaceutical Co. v. Bartlett,
570 U.S. 472 (2013) ..............................................19, 37, 44
National Cable & Telecommunications
Association v. Brand X Internet Services,
545 U.S. 967 (2005) ..........................................................47
Nesselrode v. Executive Beechcraft, Inc.,
707 S.W.2d 371 (Mo. 1986) ..................................12, 13, 33
NRDC v. EPA, 38 F.4th 34 (9th Cir. 2022) ........................15
PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) ..................36
(vii)
Racer v. Utterman,
629 S.W.2d 387 (Mo. Ct. App. 1981) ..............3, 12, 13, 44
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)...........49, 50
Rodriguez v. Suzuki Motor Corp.,
996 S.W.2d 47 (Mo. 1999) ................................................13
SEC v. Jarkesy, 603 U.S. 109 (2024) .................................31
Theatre Enterprises, Inc. v. Paramount Film
Distributing Corp., 346 U.S. 537 (1954) .......................30
Trump v. CASA, Inc., 606 U.S. 831 (2025).......................45
United States v. Carolene Products Co.,
304 U.S. 144 (1938) ..........................................................27
United States v. Mead Corp., 533 U.S. 218 (2001) ....10, 26
Wisconsin Public Intervenor v. Mortier,
501 U.S. 597 (1991) ............................................................7
Wyeth v. Levine, 555 U.S. 555 (2009) ................................39
Statutes
7 U.S.C. § 136(q) ............................................................29, 51
7 U.S.C. § 136(q)(1)–(2).........................................................9
7 U.S.C. § 136(q)(1)(A) ...... 2, 4, 10, 13, 18, 19, 20, 33, 39, 40
7 U.S.C. § 136(q)(1)(G) ..............................2, 4, 10, 13, 18, 40
7 U.S.C. § 136a(a) ..................................................................8
7 U.S.C. § 136a(c)(1)(C) ......................................8, 11, 19, 38
7 U.S.C. § 136a(c)(1)(D) ........................................................8
7 U.S.C. § 136a(c)(3)(A) ........................................................8
7 U.S.C. § 136a(c)(5) ............................................................22
7 U.S.C. § 136a(c)(5)(A)–(D) ................................................2
7 U.S.C. § 136a(c)(5)(B) ........................................ i, 8, 10, 23
7 U.S.C. § 136a(c)(6) ..........................................................2, 9
7 U.S.C. § 136a(f)(2) ...................i, 6, 9, 10, 11, 17, 28, 30, 32
(viii)
7 U.S.C. § 136d.......................................................................2
7 U.S.C. § 136j .....................................................................33
7 U.S.C. § 136j(a)(1)(A) ............................................. i, 2, 7, 9
7 U.S.C. § 136j(a)(1)(A)–(E) .................................................1
7 U.S.C. § 136j(a)(1)(B)...............................11, 18, 29, 38, 39
7 U.S.C. § 136j(a)(1)(B)–(E) .................................................2
7 U.S.C. § 136j(a)(1)(C).......................................................30
7 U.S.C. § 136j(a)(1)(E) .....................i, 2, 8, 9, 19, 21, 29, 44
7 U.S.C. § 136k(c) ................................................................31
7 U.S.C. § 136l(a)(1) ............................................................31
7 U.S.C. § 136l(b) .................................................................31
7 U.S.C. § 136n(b) ..................................................................2
7 U.S.C. § 136v(b) ...........................i, 3, 12, 20, 21, 32, 36, 50
7 U.S.C. § 136v(b)(2) ...........................................................13
7 U.S.C. § 136d.......................................................................2
21 U.S.C. § 331 .....................................................................49
21 U.S.C. § 360k(a)(1) .........................................................50
28 U.S.C. § 453 .....................................................................27
Ga. Code Ann. § 2-7-171 .....................................................28
N.D. Cent. Code § 28-01.3-11 .............................................28
Constitutional Provisions
U.S. Const. amend. VI ........................................................31
U.S. Const. art. VI, cl. 2 ........................................................4
Rules
21 C.F.R. § 314.70(c)(1) .......................................................42
21 C.F.R. § 314.70(c)(6)–(7).................................................36
21 C.F.R. § 314.70(c)(7) .......................................................42
40 C.F.R. § 152.44 ................................................................39
(ix)
40 C.F.R. § 152.46 ................................................................39
40 C.F.R. § 152.46(a)(1) .......................................................40
40 C.F.R. § 156.10(a)(5)(vii) ................................................10
EPA, Pesticide Registration Notice 95-02 (May 31,
1995) ..................................................................................40
EPA, Pesticide Registration Notice 98-10 (Oct. 22,
1998) ..................................................................................40
EPA, Pesticides; Guidance for Pesticide
Registrants on Mandatory and Advisory
Labeling Statements, 65 Fed. Reg. 31,313 (May
17, 2000) ............................................................................41
Executive Order No. 14387, Promoting the
National Defense by Ensuring an Adequate
Supply of Elemental Phosphorus and
Glyphosate-Based Herbicides, 91 Fed. Reg. 8703
(Feb. 18, 2026) ..................................................................28
Other Authorities
Bayer, Managing the Roundup Litigation .....................15
Black’s Law Dictionary (12th ed. 2024) ............................30
3 W. Blackstone, Commentaries on the Laws of
England (Robert Bell ed., 1771–72) .............................26
Cal. Office of Env’t Health Hazard Assessment,
Initial Statement of Reasons: Glyphosate (Mar.
28, 2017) ............................................................................15
EPA, Consensus Review of Glyphosate (Mar. 4,
1985) ..................................................................................14
EPA, Memorandum re Second Peer Review of
Glyphosate (Oct. 30, 1991)..............................................14
EPA, Memorandum re: Glyphosate Mouse
Oncogenicity Study (Apr. 3, 1985) ................................14
(x)
Letter from Jennifer Gaines, EPA, Office of
Pesticide Programs, to Larry Hodges, Bayer
CropScience (Dec. 17, 2012)...........................................42
Letter from Larry R. Hodges, Bayer CropScience,
to EPA, Office of Pesticide Programs (Nov. 29,
2012) ..................................................................................41
IARC Monographs Volume 112 (Mar. 20, 2015) ..............14
John F. Manning, Textualism as a Nondelegation
Doctrine, 97 Colum. L. Rev. 673 (1997) ........................25
Hiroko Tabuchi, A Trump Order Protected a
Weedkiller. And Also a Weapon of War, New
York Times, March 6, 2026 .............................................27
(xi)
In the Supreme Court of the United States
_____________
No. 24-1068
MONSANTO COMPANY, PETITIONER
v.
JOHN L. DURNELL, RESPONDENT
_____________
ON WRIT OF CERTIORARI
TO THE MISSOURI COURT OF APPEALS
_____________
BRIEF FOR THE RESPONDENT
_____________
In a typical civil case, judges announce the law and juries determine the facts. If Congress wants to adjust that
paradigm and empower a federal bureaucrat to act as
judge, jury, and executor, it must say so expressly. FIFRA
does not. To the contrary, it textually reinforces the traditional role of the judiciary. In this case, a properly empaneled jury made factual findings that Roundup caused Mr.
Durnell’s cancer and failed to warn him of that risk. On
those facts, it further concluded that Roundup was unlawful to sell under Missouri common law that tracks
FIFRA’s misbranding standards. Those straightforward
points resolve this appeal.
There is no affirmative right to sell pesticides. Instead,
FIFRA makes it “unlawful” to “distribute or sell” “any
pesticide” when one of five conditions is met. 7 U.S.C.
§ 136j(a)(1)(A)–(E) (emphasis added). Any one of those
(1)
2
conditions is sufficient to trigger a ban. The first prohibition forbids the distribution or sale of a pesticide that is
not registered by EPA. See 7 U.S.C. § 136j(a)(1)(A).
FIFRA delegates to the EPA Administrator significant
powers over registration, including the authority to evaluate evidence and make factual determinations about
safety. See 7 U.S.C. § 136a(c)(5)(A)–(D). Challenges to registration decisions are judicially reviewed deferentially
and must be affirmed when based on substantial evidence.
See 7 U.S.C. §§ 136a(c)(6), 136d, 136n(b).
Even if a pesticide is registered, however, a manufacturer still must not distribute or sell it for four independent reasons,1 including that it is “misbranded.” 7 U.S.C.
§ 136j(a)(1)(E); Bates v. Dow Agrosciences LLC, 544 U.S.
431, 438 (2005) (a pesticide can be “registered but nevertheless misbranded”). A pesticide is “misbranded,” in
turn, if it falls afoul of any of a dozen independent safeguards. At least two are implicated here. First, a pesticide
is misbranded if its label “bears any statement … which is
false or misleading in any particular.” 7 U.S.C.
§ 136(q)(1)(A). Second, a pesticide is misbranded if its 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.”
§ 136(q)(1)(G).
This Court held over 20 years ago that state failure-towarn law that imposes civil liability for selling a misbranded pesticide is not preempted. Bates, 544 U.S. at 447
(“[A] state-law labeling requirement is not pre-empted by
[FIFRA’s express preemption provision] if it is equivalent
to, and fully consistent with, FIFRA’s misbranding pro1.
See 7 U.S.C. § 136j(a)(1)(B)–(E).
3
visions.”). And Bates holds that state law is “fully consistent” with FIFRA if it targets a label’s “false or misleading statements” or “inadequate instructions or warnings.” 544 U.S. at 447 (cleaned up).
The reasoning is straightforward: Federal law forbids
those things, too. And where both sovereigns forbid the
same conduct, state law is not “in addition to or different
from”2 federal law, and there is no “logical contradiction”
between the sovereign commands. Merck Sharp &
Dohme Corp. v. Albrecht, 587 U.S. 299, 319 (2019) (Thomas, J., concurring). Both laws must be obeyed.
That is the situation here. Missouri law has long imposed “a duty on the manufacturer not to introduce into
commerce an unreasonably dangerous product” because
of its “failure to warn of danger.” Racer v. Utterman, 629
S.W.2d 387, 395 (Mo. Ct. App. 1981). So state and federal
law lay down parallel rules. State law forbids the sale of a
pesticide without a truthful and “adequate warning.”
Moore v. Ford Motor Co., 332 S.W.3d 749, 756 (Mo. 2011).
Federal law prohibits selling a pesticide with a misleading
or “inadequate warning[].” Bates, 544 U.S. at 451. Barring an outright copy-and-paste, it would be hard to have
less daylight escape between the legal standards established by state and federal law.
The facts relevant to applying Bates in this case have
all been conclusively established by a jury. Durnell used
Monsanto’s flagship pesticide, Roundup, for decades.
Though Monsanto protests that its product is safe, the
jury found that Roundup increases the risk of cancer,
caused Durnell to develop cancer, and never warned Durnell of this risk. Monsanto was therefore liable on Dur2.
7 U.S.C. § 136v(b).
4
nell’s failure-to-warn claim. Monsanto does not contest
that the jury’s verdict rests on substantial evidence.
The jury’s findings conclusively establish for purposes
of this case that Roundup is misbranded under federal
law. A label that lists carcinogens without identifying
them as such is “misleading.” 7 U.S.C. § 136(q)(1)(A). A
cancer-causing pesticide that “does not contain” a cancer
warning omits information “necessary” to protect “health
and the environment.” 7 U.S.C. § 136(q)(1)(G). The jury’s
verdict accordingly enforces a state-law duty not to sell a
dangerous pesticide that “parallel[s]” the federal duty under FIFRA’s misbranding provisions. Bates, 544 U.S. at
447.
So how, then, does Monsanto gin up the putative conflict of law necessary to implicate the Supremacy Clause?
Monsanto rests its preemption defense on the EPA Administrator’s factual finding (during the registration process) that Roundup is safe — and argues that this registration decision decisively controls whether a pesticide is
“misbranded” under federal law. Pet. Br. 35.
Monsanto’s maneuver does not withstand scrutiny.
Whether Roundup is misbranded turns on both a question
of fact: does Roundup cause cancer?; and a question of
law: is a cancer-causing pesticide that fails to warn of this
risk “inadequate” or misleading? Bates, 544 U.S. at 451.
The question of fact is one over which reasonable people — such as the jurors and the EPA Administrator —
can disagree. But absent an express statutory delegation,
the Administrator’s factual findings are not “laws of the
United States” that Congress “made in pursuance” of the
Constitution. U.S. Const. art. VI, cl. 2. The Supremacy
Clause does not of its own force anoint Lee Zeldin the
5
supreme arbiter of scientific truth with a veto over a Missouri jury. The Administrator’s factual findings during the
registration process are good for registration only. They
do not create non-mutual collateral estoppel in Durnell’s
civil action.
On the question of law, Monsanto and the Solicitor
General cannot argue that if Roundup causes cancer, but
lacks a cancer warning, it is anything other than the textbook example of a misbranded pesticide. EPA has never
offered that interpretation of the relevant congressional
definitions. And even if EPA had adopted that interpretation, it would not bind the Missouri jury because not one
word of FIFRA’s text delegates power to the Administrator to “give meaning to” these statutory provisions. Loper
Bright Enterprises v. Raimondo, 603 U.S. 369, 394 (2024).
There is similarly no provision of FIFRA that requires
judges or juries to defer to the Administrator’s determination that a pesticide complies with (or violates) the misbranding prohibition.
Yet the only way that Monsanto can prevail is by showing that FIFRA delegates Chevron-like powers to EPA,
allowing the Administrator — not judges and juries — to
conclusively interpret the law and find the facts necessary
to ascertain whether a pesticide is “misbranded.” Monsanto has not even attempted to make this showing in its
opening brief. It simply assumes that the Administrator
has these sweeping powers, spending page after page
begging the relevant question. And Monsanto cannot
show that FIFRA delegates these powers to EPA because
it faces two insuperable obstacles.
The first is Loper Bright. Courts no longer assume
that agencies rather than courts hold delegated powers to
6
render binding interpretations of federal statutes. So
Monsanto must point to statutory text that vests EPA
with the authority to render universally binding interpretations of “misbranding,” as well as the power to bind juries to its factual conclusion that Roundup is not misbranded. There is nothing in FIFRA that remotely suggests EPA can bind the judiciary on these points.
The second insurmountable obstacle is that FIFRA
contains numerous provisions that expressly reconfirm
the default rule. Most notably, 7 U.S.C. § 136a(f)(2) makes
clear that EPA’s decision to register a pesticide is not a
“defense for the commission of any offense under this subchapter.” This proves that EPA’s decision to approve a label during the registration process does not definitively
answer any factual or legal questions in a civil action that
parallels the misbranding prohibition. A jury may consider the Administrator’s determinations only as “prima
facie evidence.” 7 U.S.C. § 136a(f)(2). It is not obliged to
treat them as pronouncements ex cathedra.
Monsanto’s implied-preemption claim is equally unavailing. Monsanto claims that “federal law” compels it to
continue using the labels that EPA approved during the
registration process. But that is patently false. FIFRA
imposes no such requirement, and EPA’s own regulations — even assuming they are valid — authorized unilateral label changes without agency preapproval. Monsanto
knows this well, as its own parent company unilaterally
added a cancer warning to a pesticide label in 2012.
In any event, Monsanto’s ability to unilaterally change
the label is not determinative. Though EPA purports to
arrogate lawmaking power to itself, exclaiming that “the
7
label is the law!”3 does not make it so. The actual law is
the written text of FIFRA, which flatly requires a manufacturer to stop selling a misbranded pesticide. That duty
is the same one imposed by Missouri law. It is not impossible to simultaneously obey identical commands.
STATUTORY PROVISIONS INVOLVED
The relevant statutory provisions are included in the
appendix.
STATEMENT
I.
STATUTORY AND REGULATORY BACKGROUND
Neither Missouri nor federal law establishes “an affirmative permit scheme for the actual use of pesticides.”
Wisconsin Public Intervenor v. Mortier, 501 U.S. 597, 613
(1991). Instead, each of these independent sovereigns has
established a series of independent and overlapping rules
that forbid the sale or distribution of pesticides unless
stringent safety conditions are satisfied.
A. Federal Law
FIFRA establishes a series of independent prohibitions on selling and distributing pesticides. A pesticide
must successfully run the entire gauntlet before it can be
sold consistent with federal law.
1. Registration
Federal law forbids the distribution or sale of any pesticide unless it has first been registered with EPA. See 7
U.S.C. § 136j(a)(1)(A) (“[I]t shall be unlawful for any person in any State to distribute or sell … any pesticide that
3.
Pet. Br. 8 (quoting EPA, Pesticide Registration Manual: Introduction (May 21, 2025), https://perma.cc/RRQ4-S928).
8
is not registered under section 136a of this title”); 7 U.S.C.
§ 136a(a). To register a pesticide, an applicant must submit to EPA “the complete formula of the pesticide,” along
with “a statement of all claims to be made for it,” “directions for use,” and “a complete copy of the labeling.” 7
U.S.C. § 136a(c)(1)(C), (D).
Upon receiving an application, the EPA Administrator
must promptly “review the data” and either “register the
pesticide” or else “notify the applicant” that the application “does not comply” with FIFRA’s requirements. 7
U.S.C. § 136a(c)(3)(A). FIFRA requires EPA to make several determinations before deciding to register a pesticide, including that “its labeling and other material required to be submitted comply with the requirements of
this subchapter.” 7 U.S.C. § 136a(c)(5)(B). So the Administrator, under the registration process, assesses whether
a pesticide “compl[ies] with the requirements of ” FIFRA,
including FIFRA’s (separate) statutory prohibition on the
sale or distribution of misbranded pesticides. See 7 U.S.C.
§ 136j(a)(1)(E).
But the EPA Administrator makes these determinations only for the purpose of deciding whether to register
the pesticide under section 136a. FIFRA does not vest
him with the power to issue authoritative and final pronouncements on whether a pesticide is misbranded. Section 136a(f)(2) proves as much, stating in no uncertain
terms that:
In no event shall registration of an article be
construed as a defense for the commission of
any offense under this subchapter.
Selling an unregistered pesticide is one offense, while selling a misbranded pesticide is a distinct one.
9
To be sure, EPA is entitled to deference when it determines whether a pesticide should or should not be registered . 7 U.S.C. § 136a(c)(6). And EPA’s decision to register a pesticide is conclusive for one statutory requirement — the prohibition on the sale or distribution of unregistered pesticides. 7 U.S.C. § 136j(a)(1)(A).4 But
FIFRA does not give conclusive effect to the subsidiary
assessments of fact that the Administrator makes when
deciding whether to register a pesticide under section
136a. See 7 U.S.C. § 136a(f)(2). Outside the registration
context, Congress has not delegated to EPA the authority
to interpret or apply FIFRA’s separate misbranding provisions. Nor has Congress empowered EPA to resolve disputed legal or factual questions in a manner that binds
judges and jurors. Any factual or legal determinations
that EPA makes during the registration process are relevant only to whether EPA must register the pesticide under section 136a.
2. Misbranding
FIFRA categorically forbids the distribution or sale of
a “misbranded” pesticide. See 7 U.S.C. § 136j(a)(1)(E). A
pesticide can be “misbranded” under FIFRA for any
number of reasons. See 7 U.S.C. § 136(q)(1)–(2) (defining
“misbranded” pesticides). Two definitions are relevant
4.
If Mr. Durnell had sued Monsanto on a negligence per se theory
by claiming that EPA never should have registered Roundup —
and thus that Monsanto violated section 136j(a)(1)(A) by selling
an unregistered pesticide — EPA’s decision to register Roundup
would definitively foreclose this theory of liability. The only thing
that matters under section 136j(a)(1)(A) is whether EPA has in
fact registered the pesticide under section 136a, and no state or
federal jury is allowed to second-guess or collaterally attack
EPA’s registration decision.
10
here. First, a pesticide is misbranded if its label “does not
contain a warning or caution statement which may be necessary … to protect health and the environment.” 7 U.S.C.
§ 136(q)(1)(G). Second, a pesticide is misbranded if “its labeling bears any statement … which is false or misleading
in any particular.” 7 U.S.C. § 136(q)(1)(A). When EPA
makes its misbranding assessment at registration, it considers even “[a] true statement” misleading if “used in
such a way as to give a false or misleading impression to
the purchaser.” 40 C.F.R. § 156.10(a)(5)(vii).5
The text makes clear what this Court has confirmed:
the “unlawful act” of selling a misbranded pesticide is separate and distinct from the unlawful act of selling an unregistered pesticide. See Bates, 544 U.S. at 438 (“Because
it is unlawful under the statute to sell a pesticide that is
registered but nevertheless misbranded, manufacturers
have a continuing obligation to adhere to FIFRA’s labeling requirements.” (emphasis added)). So even if EPA determines during the registration process that a pesticide
is not misbranded — as it must as a condition for registration6— that determination is not conclusive on whether
the pesticide is actually misbranded. See 7 U.S.C.
§ 136a(f)(2) (“In no event shall registration of an article be
construed as a defense for the commission of any offense
under this subchapter.” (emphasis added)); Bates, 544
5.
6.
No provision of the statute delegates to EPA the authority to give
meaning to the words “false or misleading,” so this regulatory
gloss receives only Skidmore deference. See Loper Bright, 603
U.S. at 412–13; United States v. Mead Corp., 533 U.S. 218, 227–
28 (2001). But EPA is correct that a technically true statement
can nevertheless be “misleading” if it omits key information.
See 7 U.S.C. § 136a(c)(5)(B).
11
U.S. at 438 (“[R]egistration does not provide a defense to
the violation of the statute”).
That is because FIFRA delegates to the judiciary, not
to EPA, the ultimate power to determine whether a pesticide is misbranded within the meaning of the statute. See
Loper Bright, 603 U.S. at 412–13. EPA’s decision to register a pesticide, and EPA’s tentative assessments that a
pesticide and its label comply with the requirements of
FIFRA, serve only as “prima facie evidence” that the pesticide is not misbranded. 7 U.S.C. § 136a(f)(2).
3. Post-Registration Changes To Labels
After EPA registers a pesticide, a manufacturer may
change its label so long as the updated label complies with
FIFRA’s requirements. Monsanto claims that 7 U.S.C.
§ 136j(a)(1)(B) prohibits changes to an EPA-approved label,7 but that is demonstrably false. Section 136j(a)(1)(B)
prohibits the distribution or sale of a registered pesticide
only if the “claims made for it” substantially differ from
the “claims made for it” in the registration statement. The
“statement of all claims to be made for” a pesticide is distinct from its “labeling.” See 7 U.S.C. § 136a(c)(1)(C) (distinguishing “the labeling of the pesticide” from the “statement of all claims to be made for it”); see also pp. 37–39,
infra.8
4. Express Preemption
Section 136v provides:
7.
8.
Pet. Br. 8–9, 21, 25, 30, 45.
The Solicitor General refuses to endorse Monsanto’s characterization of section 136j(a)(1)(B). SG Br. 5, 20.
12
(a) 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) 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 means that “States may ban or restrict the uses of
pesticides that EPA has approved.” Bates, 544 U.S. at 450.
The only limitation is that a state may not enforce any “requirements for labeling or packaging” that are “in addition to or different from those required under this subchapter.” 7 U.S.C. § 136v(b).
B. Missouri Law
Missouri bars the sale of an unreasonably dangerous
pesticide that lacks an “adequate warning.” Moore, 332
S.W.3d at 756. And it defines inadequacy to include any
“warning that has been given [that] is informationally deficient.” Nesselrode v. Executive Beechcraft, Inc., 707
S.W.2d 371, 382 (Mo. 1986). A label with truthful information that nonetheless creates a “misleading effect” supports a jury verdict for failure to warn. Haberly v. Reardon Co., 319 S.W.2d 859, 867 (Mo. 1958); La Plant v. E.I.
DuPont De Nemours & Co., 346 S.W.2d 231, 245 (Mo. Ct.
App. 1961) (similar).
Missouri law does not impose a duty to change a pesticide label. It establishes only a duty “not to introduce
into commerce” a product whose label “fail[s] to warn of
danger.” Racer, 629 S.W.2d at 395 (emphasis added); see
13
also id. (“The breach of that duty occurs by the act of introducing such product into commerce.”); Nesselrode, 707
S.W.2d at 382 (similar).9 So Missouri law tracks 7 U.S.C.
§ 136(q)(1)(A) and (G) by forbidding the sale of pesticides
that lack “adequate” warnings, and leaves it to the judiciary — judges and juries — to determine whether a particular warning is “adequate.” The only differences between
Missouri law and the requirements of 7 U.S.C.
§ 136(q)(1)(A) and (G) are the remedies. Missouri requires
compensation to tort victims, while federal law authorizes
condemnation proceedings, civil penalties, and jail time.
Whether a manufacturer has violated its duty, i.e., sold
an “unreasonably dangerous” pesticide for lack of an adequate warning, is “an ultimate issue” for the jury, i.e., a
classic fact question. Moore, 332 S.W.3d at 756 (“The concept of unreasonable danger … is presented to the jury as
an ultimate issue without further definition.” (cleaned
up)). The jurors “give[] th[e] concept [of unreasonable
danger] content by applying their collective intelligence
and experience to the broad evidentiary spectrum of facts
and circumstances presented by the parties.” Nesselrode,
707 S.W.2d at 378. A product can be unreasonably dangerous both because of a true “absence of a warning” or because “the warning that has been given is informationally
deficient.” Id. at 382. In arguing about whether the pesticide was in fact unreasonably dangerous, the defendant is
permitted “to argue that the utility of a design outweighs
its risks.” Rodriguez v. Suzuki Motor Corp., 996 S.W.2d
47, 65 (Mo. 1999) (cleaned up). So a defendant is free to
9.
These duties imposed by Missouri law still qualify as “requirements for labeling” under 7 U.S.C. § 136v(b)(2).
14
argue that the benefits of the product as sold outweigh any
costs.10
II. PROCEDURAL HISTORY
A. History Of Roundup Litigation
Roundup is a weedkiller developed by Monsanto. Its
active ingredient is glyphosate, which kills plants at their
roots. In 1985, EPA reviewed a rodent-model study showing that “glyphosate was oncogenic” and caused “rare tumor[s].”11 Based on that review, EPA classified glyphosate
as a possible human carcinogen.12 It later reclassified
glyphosate as a chemical for which there exists “evidence
of non-carcinogenicity for humans.”13 Over the next decade, studies showed that glyphosate was possibly genotoxic, i.e., capable of causing mutations in genes that lead
to cancer. Court of Appeals Respondent’s Appendix 41, 73.
In 2015, the International Agency for Research on
Cancer (IARC) concluded that glyphosate is probably
carcinogenic to humans.14 Two years later, California cate10. Monsanto repeatedly made those arguments to the jury here.
See, e.g., JA 135–136 (describing how Roundup is “a big deal to
farmers” because it kills weeds, which “actually make it impossible for [farmers] to grow food because it blocks the sun”); JA 136
(describing Roundup as “an advance” from other pesticides that
were “toxic” and created “environmental issues like sticking
around for a long time in the soil and groundwater”).
11. EPA, Memorandum re: Glyphosate Mouse Oncogenicity Study
(Apr. 3, 1985), https://perma.cc/T6FJ-VAL9.
12. See EPA, Consensus Review of Glyphosate (Mar. 4, 1985),
https://perma.cc/Z4ZZ-PE8Z.
13. EPA, Memorandum re Second Peer Review of Glyphosate (Oct.
30, 1991), https://perma.cc/5GEG-RFH3.
14. IARC Monographs Volume 112 (Mar. 20, 2015), https://perma.cc/
L79E-6LEF.
15
gorized glyphosate as a carcinogen under Proposition
65.15 In 2020, EPA issued an “interim decision” stating
EPA’s own view that “glyphosate is not likely to be carcinogenic to humans.” NRDC v. EPA, 38 F.4th 34, 43 (9th
Cir. 2022). The Ninth Circuit then vacated EPA’s factual
findings after holding them unsupported by substantial
evidence and inconsistent with the views of EPA’s own epidemiologists. Id. at 51. EPA never sought review in this
Court, so the vacatur is final. 16
In 2021, Monsanto’s parent company, Bayer, announced that it would discontinue its glyphosate-based
products sold in the residential market. Although farmers
continue to use glyphosate-containing Roundup, Monsanto says that it has been using other ingredients in
Roundup for the lawn-and-garden market since 2023.17
B. History Of This Suit
John L. Durnell began using Roundup in 1996. For
more than 20 years, he sprayed Roundup without wearing
protective equipment. Based on Monsanto’s label and
marketing, Durnell believed that Roundup was safe. In
2018, Durnell was diagnosed with mantle cell lymphoma,
a rare and aggressive form of non-Hodgkin lymphoma.
Durnell sued Monsanto in Missouri state court, bringing design-defect and failure-to-warn claims. He present15. Cal. Office of Env’t Health Hazard Assessment, Initial Statement of Reasons: Glyphosate (Mar. 28, 2017), https://perma.cc/
N4DK-FWEG.
16. Monsanto’s unbalanced and tendentious presentation of the scientific evidence does not reflect reality. See Brief of Amici Curiae
Roundup and Paraquat MDL Leadership.
17. Bayer, Managing the Roundup Litigation, https://perma.cc/
UGV5-Y8MV.
16
ed expert testimony that Roundup caused his cancer and
that Monsanto had failed to warn about it. Monsanto
never requested a Bates instruction to ensure that the
jury would interpret and apply Missouri law in a manner
consistent with FIFRA’s misbranding requirements.18
The jury awarded Durnell $1.25 million on his failure-towarn claim. To reach this verdict, the jury necessarily had
to find that Roundup lacked an adequate warning and
caused Durnell’s cancer. The jury found for Monsanto on
the remaining claims.
Monsanto appealed to the Missouri Court of Appeals.
Monsanto did not contest that the jury’s verdict rests on
substantial evidence, but argued only that Durnell’s failure-to-warn claim was preempted. The Missouri Court of
Appeals affirmed, holding that Missouri law does not impose any requirement “in addition to or different from”
those imposed by FIFRA. Pet. App. 7. The Missouri Supreme Court declined further review, and this Court
granted certiorari.
SUMMARY OF ARGUMENT
The Court should reject Monsanto’s preemption arguments and affirm.
Monsanto and the Solicitor General are making two
separate arguments for express preemption. Their first
18. Bates holds that juries considering failure-to-warn claims must
be instructed to apply state law in a manner that tracks the misbranding requirements of FIFRA, but it places the onus on the
defendant to request such a jury instruction if it believes that
state law could extend beyond federal labeling requirements. See
Bates, 544 U.S. at 454 (“If a defendant so requests, a court should
instruct the jury on the relevant FIFRA misbranding standards.”); see also pp. 34–35, infra.
17
argument is that EPA has authoritatively pronounced
that Roundup’s labeling does not violate FIFRA’s misbranding provisions. On this view, EPA’s approval of the
label represents a binding agency determination that the
label comports with federal law, so any state-law failureto-warn claim over an EPA-approved label will add to the
federal labeling requirements under section 136v(b).
This argument fails because EPA has no delegated authority to interpret or apply FIFRA’s misbranding provisions in a manner that binds the judiciary. Under Loper
Bright, it is for courts to determine the meaning of
FIFRA’s provisions absent an express delegation of interpretive authority to the agency. Monsanto does not even
attempt to identify any language in FIFRA that departs
from Loper Bright’s default rule. Instead, Monsanto begs
the question by assuming that EPA’s beliefs on the legality of Roundup’s labeling must somehow bind the courts,
and that EPA’s factual assertions that glyphosate is noncarcinogenic must somehow bind juries under a doctrine
akin to nonmutual collateral estoppel. But there is no statutory language in FIFRA that purports to give EPA these
powers, and there are numerous provisions throughout
FIFRA that explicitly refute the notion that EPA’s registration decision has binding effect in subsequent court
proceedings. Foremost among them is 7 U.S.C.
§ 136a(f)(2), which explicitly prohibits EPA’s registration
decisions from being invoked as a “defense” to a misbranding charge.
Monsanto and the Solicitor General’s second argument for express preemption is equally unavailing. They
contend that Missouri’s failure-to-warn law differs from
the requirements of FIFRA because federal law compels
18
courts to consider both costs and benefits when deciding
whether a pesticide warning is “adequate” under 7 U.S.C.
§ 136(q)(1)(G), while Missouri merely allows the factfinder to conduct a cost-benefit analysis. Pet. Br. 43; SG
Br. 24–25. But FIFRA requires consideration of both
costs and benefits when the only basis for declaring a pesticide “misbranded” is failure to include an “adequate”
warning under 7 U.S.C. § 136(q)(1)(G). FIFRA does not
require (or even allow) consideration of costs and benefits
when a pesticide is misbranded because its label is “misleading” under 7 U.S.C. § 136(q)(1)(A), and a label that
lists carcinogens as ingredients without mentioning the
risk of cancer is “misleading” (and thus misbranded) under FIFRA. Monsanto also forfeited this argument by
failing to request a Bates instruction that would have told
the jury to apply Missouri law in a manner that tracks
FIFRA’s misbranding requirements. See Bates, 544 U.S.
at 454. And any forfeited error in the jury instructions
would be harmless, as it is inconceivable that a jury instructed to apply cost-benefit analysis would conclude
that (1) Roundup in fact caused Durnell’s cancer but (2)
the supposed financial benefits of the weedkiller somehow
outweigh the minimal costs of including a life-saving cancer warning.
Finally, the Court should reject Monsanto’s impliedpreemption argument. If Missouri and federal law impose
the same duty — as required to avoid express preemption — it is logically impossible for Monsanto to show impossibility. Monsanto claims that “federal law” prohibits
it from adding a cancer warning to its Roundup labels, but
nothing in FIFRA or EPA’s regulations says that. Monsanto repeatedly cites 7 U.S.C. § 136j(a)(1)(B), but that
19
provision does not mention labels, and prohibits manufacturers from altering only the “claims made for” the pesticide in the registration statement. See 7 U.S.C.
§ 136a(c)(1)(C). Monsanto also asserts that adding a cancer warning on its Roundup labels would render those labels “false” under 7 U.S.C. § 136(q)(1)(A), but Monsanto
could add tomorrow an indisputably truthful and appropriately hedged warning such as: “The International
Agency for Research on Cancer considers glyphosate
probably carcinogenic to humans.” Monsanto also mischaracterizes EPA’s regulations, which allow these sorts
of label changes without EPA’s preapproval.
Even if FIFRA or EPA’s regulations somehow barred
Monsanto from adding a cancer warning, that still would
not establish impossibility. That is because FIFRA requires Monsanto to comply with the statutory misbranding provisions, regardless of whether EPA regulations allow Monsanto to alter a label. 7 U.S.C. § 136j(a)(1)(E). If
Roundup’s labels are misleading or inadequate, then
Monsanto must either stop selling Roundup, as it has in
the residential market, or pay the damages that result
from its decision to distribute or sell a pesticide that Durnell’s jury found was misbranded. When both state and
federal law require cessation, stopping is both possible
and required. See Mutual Pharmaceutical Co. v. Bartlett,
570 U.S. 472, 487 n.4 (2013).
ARGUMENT
I.
DURNELL’S FAILURE-TO-WARN CLAIM IS NOT
EXPRESSLY PREEMPTED
FIFRA preempts state laws only when they impose
labeling requirements “in addition to or different from
20
those required under” FIFRA. 7 U.S.C. § 136v(b). Monsanto cannot establish a preemption defense under this
section for two reasons.
First, Missouri tort law does not impose any labeling
requirements that add to or differ from FIFRA’s requirements. That is because: (1) Missouri law tracks the language of 7 U.S.C. § 136(q)(1)(A), (G) by requiring “adequate” warnings on pesticide labels that are not “false or
misleading”; and (2) Both Missouri law and FIFRA delegate to the judiciary the power to fill the interstices of
their adequate-warning requirement. So both state and
federal law establish identical legal standards, and each of
them empowers the same actors — judges and jurors — to
decide whether a particular pesticide label actually contains lawful warnings. Monsanto’s argument to the contrary presumes that FIFRA has delegated to EPA the
power to interpret the misbranding prohibition in a manner that binds state and federal judiciaries. But Monsanto
never even attempts to explain how FIFRA delegates
these powers to EPA given the holding of Loper Bright.
Second, even if Monsanto could show some difference
between Missouri law and FIFRA, it still cannot prevail
on its express-preemption defense. As an initial matter,
Monsanto forfeited its affirmative defense by failing to
ask for a Bates instruction at trial. Regardless, any error
was harmless, as no jury that necessarily found that
Roundup causes cancer would conclude that the benefits
of ignorance outweigh the costs of the truth.
A. Missouri Tort Law Does Not Add To Or Differ From
FIFRA’s Adequate-Warning Requirement
Monsanto’s and the Solicitor General’s more ambitious express-preemption argument depicts EPA’s deci-
21
sion to register a pesticide as the final and authoritative
pronouncement that the pesticide complies with the misbranding prohibition. On this theory, any failure-to-warn
claim against an EPA-approved label is automatically
preempted by 7 U.S.C. § 136v(b). Pet. Br. at 23–26. Because registration is simply EPA’s application of the
FIFRA requirements, not a binding determination that
changes their legal content, the argument fails.
1. FIFRA Delegates To The Judiciary And Not EPA
The Power To Determine Whether Roundup Is
Misbranded
If FIFRA authorizes the judiciary to decide whether
Roundup is misbranded under 7 U.S.C. § 136j(a)(1)(E),
then the jury verdict and the Missouri Court of Appeals’
ruling do not “add” anything to FIFRA’s labeling requirements. They represent nothing more than a judicial interpretation and application of the adequate-and-non-misleading-warning standard, which is established in FIFRA
and mirrored in Missouri law. A court does not “add” to or
“differ” from existing law by applying an established legal
standard to a particular set of facts. And a state does not
“add” to the labeling requirements of FIFRA by authorizing judges and jurors to enforce parallel state law.
EPA’s determinations that a label complies with
FIFRA’s misbranding provisions are nothing more than
EPA’s opinion on the matter, and they do not bind the
courts unless Congress has delegated interpretative authority to the Administrator. See Loper Bright, 603 U.S.
at 413 (“[W]hen a particular statute delegates authority to
an agency consistent with constitutional limits, courts
must respect the delegation, while ensuring that the
agency acts within it.”).
22
Monsanto’s brief assumes that FIFRA vests EPA
with powers to bind the judiciary to its interpretations
and applications of the statutory misbranding provisions.
But Monsanto never attempts to explain how the statutory text could be read to provide such a delegation given
Loper Bright, which holds that the default regime empowers courts to interpret and apply the law. Id. at 394–96,
412–13. That default applies because FIFRA’s registration provision delegates only narrow and carefully defined
powers to EPA. Consider the text of 7 U.S.C. § 136a(c)(5):
The Administrator shall register a pesticide if
the Administrator determines that, when considered with any restrictions imposed under
subsection (d) —
(A) its composition is such as to warrant the proposed claims for it;
(B) its labeling and other material required to
be submitted comply with the requirements of
this subchapter;
(C) it will perform its intended function without
unreasonable adverse effects on the environment; and
(D) when used in accordance with widespread
and commonly recognized practice it will not
generally cause unreasonable adverse effects on
the environment.
All of the Administrator’s factfinding authority is textually linked to his power to “register a pesticide.” That
includes determining whether a pesticide’s proposed la-
23
beling “compl[ies] with the requirements”19 of FIFRA.
The statute requires EPA to register a pesticide if it concludes that its labeling complies with FIFRA and that the
remaining requirements of section 136a(c)(5) have been
met.
But this provision does not vest EPA with authority to
conclusively and definitively resolve whether a pesticide’s
label complies with FIFRA in an adversarial judicial proceeding. It merely instructs EPA to make a one-time, limited-purpose determination whether the label (in EPA’s
opinion) comports with FIFRA’s registration requirements. The powers conferred by section 136a(c)(5) cannot
be construed to give EPA authority to render binding pronouncements on whether a pesticide actually violates
FIFRA’s misbranding provisions. This is so for at least
three reasons.
First, EPA’s findings during the registration process
are based on the limited information submitted at that
time, and subsequent discoveries could show that an EPAregistered pesticide is in fact misbranded. It is untenable
to think that section 136a(c)(5) would make EPA’s approval of a label during the registration process the authoritative and conclusive determination of whether a label actually and always complies with FIFRA’s misbranding provisions.
Second, the statute provides that the only legal consequence of EPA’s decision to approve a label during the
registration process is that EPA “shall register” the pesticide, so long as the remaining criteria listed in section
136a(c)(5) are also met. Neither section 136a nor any other
provision of FIFRA purports to attach additional legal
19. 7 U.S.C. § 136a(c)(5)(B).
24
significance to EPA’s determination that a proposed label
complies with the statutory misbranding provisions.
Third, there is no language in section 136a(c)(5) or
elsewhere in FIFRA that purports to delegate such
sweeping interpretive powers to EPA.20 After Loper
Bright, Monsanto must point to text that expressly vests
EPA with authority to render conclusive pronouncements
on the meaning of FIFRA’s misbranding provisions and
their application to particular pesticides. Monsanto has
not even attempted to carry its burden,21 content to assume that FIFRA departs from Loper Bright’s rule without presenting an argument to that effect.
20. Does Monsanto truly believe that section 136v’s reference to requirements “under” FIFRA — as opposed to “by” FIFRA —
shows that Congress delegated to EPA the authority to definitively pronounce that a pesticide’s label is not misbranded? Pet.
Br. 26–27. That “is too extravagant to be maintained.” Marbury
v. Madison, 1 Cranch 137, 179 (1803). Congress’s choice of preposition comes nowhere close to a legislative decision to “expressly
delegate” binding interpretative authority to EPA or to empower
the Administrator to “fill up the details” of the misbranding prohibition. Loper Bright, 603 U.S. at 394–95 (cleaned up). Whether
requirements are created “under,” “by”, or “in” FIFRA, Monsanto must show on the face of the statute that Congress intended
to give controlling legal effect to EPA pronouncements “that do
not appear on the face of the statute.” Pet. Br. 26. Apart from
EPA’s decision to register a pesticide, Monsanto has not and will
not make that showing.
21. Neither has the Solicitor General, who baldly asserts that EPA’s
determinations under section 136a(c)(5) have binding legal force
without ever bothering to address the delegation issue. See SG
Br. 27 (“[W]hen EPA carries out its duties under FIFRA by making a statutorily required determination — here, whether a pesticide contains all warnings necessary and adequate to protect human health — that determination preempts different state-law
requirements on the topic.”).
25
To the extent one can cobble together a delegation argument from Monsanto’s brief, it rests on nothing more
than snippets of legislative history22 and handwringing
over the policy implications of a non-preemption holding.23
As Monsanto would have it, EPA must be vested with delegated authority to construe FIFRA’s misbranding provisions and render binding factual determinations on whether glyphosate causes cancer — even though Monsanto
cannot identify any statutory language empowering EPA
to displace the judiciary’s law-interpretation and factfinding functions — because congressional committee reports
discuss the need for “balance” and “uniformity,”24 and because agency diktats are needed to prevent a “crazyquilt”25 of conflicting state regulations. That won’t cut it
under the Loper Bright regime. Agencies must identify
textual delegations of authority before their pronouncements can bind the judiciary, and delegations to agencies
cannot be effectuated through congressional committee
reports. See Epic Systems Corp. v. Lewis, 584 U.S. 497,
523 (2018) (“[L]egislative history is not the law.”); John F.
Manning, Textualism as a Nondelegation Doctrine, 97
Colum. L. Rev. 673 (1997).
Monsanto’s policy concerns are likewise irrelevant to
the delegation issue. A desire to promote “uniformity” is
no reason to construe federal statutes as vesting agencies
with the power to bind courts to their interpretations and
applications of the law. See Loper Bright, 603 U.S. at 403.
If Monsanto wants to wage a rearguard action against this
22. Pet. Br. 5–6.
23. Pet. Br. 36–37, 50–53.
24. Pet. Br. 6 (quoting H.R. Rep. No. 104-669(II), at 29-30 (1996)).
25. Pet. Br. 2, 6.
26
holding, it should say so candidly. A mere two years after
Loper Bright, the Court should not begin creating one-off
exceptions of the sort that eventually doomed Chevron’s
presumed-delegation regime. See id. at 404–06.
Monsanto’s concerns about balkanized and conflicting
state regulatory regimes are also overblown. Section 136v(b) prohibits state legislatures from enacting labeling requirements that cannot be found in FIFRA. So
there is no possibility of conflicting state legislation over
whether pesticide warnings must appear in red or yellow
letters or whether ignitable pesticides will be described as
“flammable” or “inflammable.” Pet. Br. 5. There is also no
judge or jury that will find a pesticide insufficiently labeled under state common law over issues of coloring or
nomenclature, and any manufacturer sued on such a theory would be entitled to a directed verdict. And EPA’s labeling regulations are still entitled to Skidmore deference
from the judiciary, even though EPA lacks delegated interpretive authority over FIFRA’s misbranding provisions. See Mead, 533 U.S. at 227–28.
Courts and juries may well diverge in applying the
standards in FIFRA, but that is always the consequence
of allowing citizen fact-finders — not government technocrats — to safeguard the people’s cherished rights. Where
Monsanto and the Solicitor General see a “patchwork”26
or hear a “cacophony,”27 Madison and Blackstone saw “the
glory of the English law.” 3 W. Blackstone, Commentaries
on the Laws of England 379 (Robert Bell ed., 1771–72).
Monsanto cannot deny the power of the jury to determine
26. Pet. Br. 5, 50–51; SG Br. 13.
27. Pet. Br. 5; SG Br. 4.
27
the ultimate facts when applying the standards from state
tort law that parallel FIFRA’s requirements.
Monsanto also worries that preemption is needed to
protect American “agriculture and innovation.” Pet. Br.
50. That cannot serve as a reason to construe FIFRA as
giving EPA powers to bind the judiciary. Courts do not
have the capacity to assess the policy consequences of
their rulings, and judges are bound by oath to administer
justice without regard to persons or pesticides. See 28
U.S.C. § 453. Whatever preemptive force FIFRA might
have over state law is entirely unaffected by the importance of the pesticide or the effects that liability might
have on the overall economy. If a non-preemption holding
would produce the dire results Monsanto fears, then it
must ask Congress and not the courts to change the law.
Monsanto and its parent company Bayer have more than
enough clout with state and federal officials,28 and they are
about as far as one can get from the “discrete and insular
minorities”29 that can rely only on courts to protect their
interests.
Indeed, after a decade of litigation and billions of dollars of settlement payments, Monsanto has been vigorously lobbying Congress and state legislatures to secure
the immunity from suit that the company is telling this
Court has been hidden in a law of the United States since
1974. In 2023 and 2024, Monsanto tried to insert a provision into FIFRA that bars state-law liability “for failing
28. See, e.g., Hiroko Tabuchi, A Trump Order Protected a Weedkiller. And Also a Weapon of War, New York Times, March 6, 2026,
http://bit.ly/40wpdac (visited March 25, 2026)
29. United States v. Carolene Products Co., 304 U.S. 144, 152 n.4
(1938).
28
to comply with requirements with respect to labeling or
packaging that is in addition to or different from the labeling or packaging approved by the Administrator.”30
The difference between the law Monsanto wishes Congress would enact and the one that has already navigated
the bicameralism and presentment process is obvious.
Perhaps the political branches will be swayed by Monsanto’s policy arguments and enact the express preemption clause the company so desperately seeks. The executive branch, at least, seems receptive to Monsanto’s entreaties. See Executive Order No. 14387, Promoting the
National Defense by Ensuring an Adequate Supply of
Elemental Phosphorus and Glyphosate-Based Herbicides, 91 Fed. Reg. 8703 (Feb. 18, 2026). But this Court is
confined to reviewing the enacted law, not the rewrite a
massive corporation might one day shepherd through the
halls of Congress.
2. FIFRA’s Provisions Show That EPA’s Decision To
Register A Pesticide Does Not Preclude Courts
From Finding That Pesticide Misbranded
FIFRA explicitly negates the idea that EPA’s approval of a label during the registration process somehow
insulates that label from subsequent judicial attack.
Start with 7 U.S.C. § 136a(f)(2), which says:
In no event shall registration of an article be
construed as a defense for the commission of
any offense under this subchapter. As long as no
30. H.R. Rep. No. 188-4288, at 2 (2023). Monsanto has also persuaded
lawmakers in Georgia and North Dakota to enact immunity legislation under state tort law. Ga. Code Ann. § 2-7-171; N.D. Cent.
Code § 28-01.3-11.
29
cancellation proceedings are in effect registration of a pesticide shall be prima facie evidence
that the pesticide, its labeling and packaging
comply with the registration provisions of the
subchapter.
This means that there will be EPA-approved labels that
courts may find “inadequate” or “misleading” under 7
U.S.C. § 136(q). That cannot be squared with Monsanto’s
claim that the use of an EPA-approved label prevents
courts from finding that label “inadequate” or “misleading” under FIFRA or a state law that tracks the federal
misbranding standards.
The statute also says that EPA’s decision to register a
pesticide — and the concomitant determinations that EPA
makes during the registration process — serve as nothing
more than “prima facie evidence” that the label complies
with FIFRA’s registration provisions. Monsanto, by contrast, is insisting that EPA’s determinations have res judicata effect. Cf. B&B Hardware, Inc. v. Hargis Industries, Inc., 575 U.S. 138, 148 (2015) (allowing agency findings to bind a court only when the agency was “acting in a
judicial capacity” and all the issue-preclusion factors are
met, including an issue actually litigated between the
same parties (cleaned up)).
Monsanto and the Solicitor General try to get around
section 136a(f)(2) by suggesting it applies only when
someone sells a pesticide without the EPA-approved label
or in violation of its terms of registration. Pet. Br. 38–39;
SG Br. 26. But according to Monsanto, that conduct is
prohibited by 7 U.S.C. § 136j(a)(1)(B), not the misbranding provision of (a)(1)(E). Pet. Br. 8–9, 21, 25, 30. The separate prohibition on selling a misbranded pesticide —
30
which surely counts as “any offense” under FIFRA —
does not do any work on Monsanto’s view. Superfluity is
not Monsanto’s only problem. The text of section
136j(a)(1)(B) forbids selling a “registered pesticide” with
claims that differ from “the statement required in connection with its registration.” The very next section uses
identical language, forbidding the sale of a “registered
pesticide” if the composition differs from the registration
statement. 7 U.S.C. § 136j(a)(1)(C). If the misbranding
prohibition were only meant to cover a registered pesticide that departed from the label contained in the registration statement, surely Congress would have used a
parallel formulation.
One needs only to read section 136a(f)(2) to see that it
applies without regard to the type of FIFRA violation that
a plaintiff or prosecutor alleges. See 7 U.S.C. § 136a(f)(2)
(“In no event shall registration of an article be construed
as a defense for the commission of any offense under this
subchapter.” (emphases added)). And Monsanto does not
engage with the second sentence of 7 U.S.C. § 136a(f)(2),
which makes EPA’s label-approval decisions “prima facie
evidence” of statutory compliance. Prima facie evidence,
by its very nature, is evidence that can be rebutted in
court. See Black’s Law Dictionary (12th ed. 2024). Indeed,
the reason this Court long ago construed an almost identical provision in the Interstate Commerce Act not to violate the Seventh Amendment is because making an
agency finding “prima facie evidence” “takes no question
of fact from either court or jury.” Meeker v. Lehigh Valley
R. Co., 236 U.S. 412, 430 (1915) (emphasis added); see also
Theatre Enterprises, Inc. v. Paramount Film Distributing Corp., 346 U.S. 537, 541 (1954) (Prima facie evidence
31
was not enough, even in conjunction with other evidence,
to form the basis for a directed verdict). Without even
grappling with the text, Monsanto wants to convert
“prima facie evidence” into an irrebuttable presumption.31
If EPA’s determinations about misbranding were conclusive, they would apply with as much force whenever the
Administrator believes that a pesticide is misbranded as
when he thinks, as here, that one is not misbranded. After
all, a textual delegation to definitively announce misbranding vel non does not turn on the answer the Administrator gives for a particular pesticide. But FIFRA unambiguously rejects that approach. Section 136k, for example, allows the United States to bring condemnation actions against misbranded pesticides, but it guarantees the
right to a jury trial in those proceedings. See 7 U.S.C.
§ 136k(c) (“[E]ither party may demand trial by jury of any
issue of fact joined in any case”). FIFRA also empowers
the Administrator to seek civil penalties against those
who distribute or sell misbranded pesticides,32 where the
accused would be constitutionally entitled to a jury trial
under the Seventh Amendment. See SEC v. Jarkesy, 603
U.S. 109 (2024). And FIFRA authorizes criminal prosecutions of those who knowingly violate the statute’s misbranding provision,33 where the defendant likewise enjoys
a constitutional right to a jury trial. See U.S. Const.
amend. VI; Bates, 544 U.S. at 452 (“In criminal prosecu31. It is astounding that Monsanto would deny that juries may “second-guess” the findings and determinations that EPA makes
during the registration process when section 136a(f)(2) not only
allows but explicitly invites courts and juries to second-guess
those findings and determinations. Pet. Br. 2, 22, 50.
32. 7 U.S.C. § 136l(a)(1).
33. See 7 U.S.C. § 136l(b).
32
tions for violation of FIFRA’s provisions … juries necessarily pass on allegations of misbranding.”).
In all of these judicial proceedings, there would be
nothing for a jury to do if jurors must simply accept the
Administrator’s factual determinations and legal conclusions as binding “laws of the United States.” Yet Congress
expressly contemplated that a jury will decide for itself
whether a pesticide is misbranded under FIFRA, performing its traditional role of resolving any disputed questions of fact relevant to the inquiry. The jury can consider
EPA’s views as “prima facie evidence,” 7 U.S.C.
§ 136a(f)(2), which is the opposite of a legal conclusion that
cannot be second guessed absent jury nullification.
Congress’s decision to reaffirm the right to trial by
jury hammers home that FIFRA does not delegate to
EPA the prerogative to decree as a matter of law whether
a pesticide is misbranded as a matter of fact. No different
result can obtain when a litigant such as Durnell is contesting EPA’s belief that a pesticide is not misbranded.
FIFRA delegates these decisions to judges and juries regardless of whether EPA takes the side of the injured tort
victim or the manufacturer.
Monsanto’s next move, echoed by the Solicitor General, is to claim that the Court can ignore section
136a(f)(2) because it “is not a preemption provision at all,”
Pet. Br. 38–39; SG Br. 25–27. So what? By negating registration as a defense to any federal offense, section
136a(f)(2) confirms beyond doubt that the separate prohibition on selling a misbranded pesticide remains a federal “requirement.” Missouri failure-to-warn law is thus
free to operate so long as it parallels that federal obligation. 7 U.S.C. § 136v(b). Indeed, the key federal require-
33
ments themselves are not contained in “a preemption provision,” see 7 U.S.C. § 136j, but that hardly makes them
irrelevant to an express-preemption clause that turns entirely on whether state law dictates what federal law also
compels.
3. Missouri’s Warning Requirements Do Not Add To
Or Differ From FIFRA’s Misbranding Provisions
Monsanto and the Solicitor General have a more modest express-preemption theory. They try to concoct a “difference” between Missouri and federal warning regimes
by claiming that FIFRA requires consideration of costs
and benefits when assessing the “adequacy” of a warning,
while Missouri merely allows that analysis. Pet. Br. 40–43;
SG Br. 24–25. But this argument pretends that the statutory definition of “misbranding” encompasses only the adequate-warning requirement in 7 U.S.C. § 136(q)(1)(G).
Monsanto and the Solicitor General completely ignore the
definition that forbids the sale of pesticides with a “false
or misleading” label. See 7 U.S.C. § 136(q)(1)(A); cf. Bates,
544 U.S. at 438 (citing that provision). That definition of
“misbranding” does not require or even allow cost-benefit
analysis.
Missouri law similarly allows a jury to determine
whether Roundup’s label is “informationally deficient” by
listing glyphosate without disclosing its risks.34 This does
not reach beyond the requirements of FIFRA, which categorically prohibits “misleading” labeling without regard
to costs or benefits, and it vests the judiciary with auth34. See Nesselrode, 707 S.W.2d at 382; La Plant, 346 S.W.2d at 245;
Haberly, 319 S.W.2d at 867 (similar holding regarding a label
with “misleading effect”).
34
ority to determine whether a particular pesticide label is
“misleading” (and therefore misbranded). So Missouri’s
failure-to-warn law does not add to or differ from
FIFRA’s misbranding requirements, regardless of the extent to which Missouri law merely allows or requires consideration of cost-benefit analysis.
B. Even If Monsanto Could Show That Missouri Tort
Law Adds To Or Differs From FIFRA, Monsanto
Forfeited This Argument By Failing To Ask For A
Bates Instruction At Trial
Even if Monsanto could show some difference between
Missouri law and FIFRA, it still cannot prevail because
Monsanto forfeited this affirmative defense by failing to
ask for a Bates instruction at trial. To ensure that Monsanto was found liable only for a “genuinely equivalent”
Missouri labeling requirement, the burden was on the
company to “request[]” an instruction “on the relevant
FIFRA misbranding standards.” Bates, 544 U.S. at 454.
Monsanto, however, agreed with the jury instructions in
the trial court and never challenged them on appeal.
Bates was right to require defendants to seek corrective jury instructions where state common law could extend beyond the requirements of FIFRA. Federal preemption operates as applied, displacing only the applications of state law that conflict with federal law. English v.
General Electric Co., 496 U.S. 72, 79 (1990) (“[S]tate law
is pre-empted to the extent that it actually conflicts with
federal law”); Bates, 544 U.S. at 453 (If state law imposed
a “broader obligation” than FIFRA, plaintiff ’s claim
would be preempted only “to the extent of that difference.”). If Missouri law permitted Durnell to recover on
one theory of liability that entirely tracks FIFRA, i.e., one
35
where a necessary cost-benefit analysis cuts in plaintiff ’s
favor, and another theory that is slightly easier for plaintiff to satisfy, i.e., one where a cost-benefit analysis is
merely a consideration, the burden was on Monsanto to
seek the appropriate limiting instruction so the jury could
only return a plaintiff ’s verdict on the parallel theory.
Monsanto cannot convert section 136v(b) into a categorical immunity from suit by lying behind the log and refusing to request a jury instruction that would have obviated
its grievances with the scope of Missouri law.
Even if this Court were to assume that Monsanto had
preserved its objections to the jury instructions, any failure to make the jury conduct a cost-benefit analysis was
harmless. There is no conceivable scenario in which a jury
would conclude: “Roundup causes cancer, but it was acceptable not to warn Durnell of this deadly risk because
the benefits of ignorance induced him and others to keep
using the product, leaving gardens beautiful and farm
yields abundant. You cannot have manicured lawns and
cheap groceries without some people getting cancer, so
omitting the warnings was worth it.” That kind of callous
disregard for human agency and informed consent would
be dead on arrival even at a University of Chicago lawand-economics seminar. There is no chance it would have
persuaded Durnell’s jury — which even Monsanto agrees
was permitted to consider costs and benefits — to reach a
different verdict.35
35. If the Court holds that Missouri’s state-law labeling requirements reach beyond the commands of FIFRA and further rejects
Durnell’s forfeiture and harmless-error defenses, it should remand for a new trial with proper jury instructions under Bates.
36
II. DURNELL’S FAILURE-TO-WARN CLAIM IS NOT
IMPLIEDLY PREEMPTED
Durnell’s claim is not expressly preempted because it
is not “in addition to or different from” federal law. 7
U.S.C. § 136v(b). That means Missouri law imposes the
same requirements that appear in the federal misbranding provisions: do not sell a pesticide the label of which is
misleading or inadequate.
That dooms Monsanto’s impossibility-preemption argument as a matter of basic logic. Two equivalent commands cannot logically contradict each other, so no court
would view federal law as displacing state law under the
traditional doctrine of implied repeals. PLIVA, Inc. v.
Mensing, 564 U.S. 604, 622 (2011) (plurality op.) (“[F]ederal law should be understood to impliedly repeal conflicting state law.”) (citing Caleb Nelson, Preemption, 86 Va.
L. Rev. 225 (2000)). Nor is it “impossible” to do what both
state and federal law require. Albrecht, 587 U.S. at 313.
Refusing to accept state and federal duties on their
own terms, Monsanto repackages its obligation under
Missouri law as a duty to change the label. Even with this
framing, Monsanto has come nowhere close to establishing the “demanding defense” of impossibility. Id. Nothing
in FIFRA prevents unilateral label changes to cure a misbranded label. See pp. 38–39, infra. EPA’s regulations,
even if they carried the force of law, permitted such
changes. See pp. 39–42, infra. And there is no EPA rule
akin to the pharmaceutical Changes Being Effected regulation that would allow the Administrator to order Monsanto to walk back a unilateral change. 21 C.F.R.
§ 314.70(c)(6)–(7).
37
Though Monsanto could have (and should have)
changed Roundup’s label, it was duty bound not to sell a
misbranded pesticide under state and federal law. And although this Court has rejected a “stop-selling” response
when only state law imposes a labeling requirement,36 the
analysis is entirely different when federal law also compels an actor to stop selling the product that is mislabeled
under state law. Bartlett, 570 U.S. at 487 n.4. If state and
federal law both require an actor to stop selling, it is not
impossible to obey both commands.
In short, there is no impossibility because: (1) Nothing
in FIFRA or EPA's regulations prevented Monsanto from
adding a cancer warning; and (2) Even if federal law prevented Monsanto from changing Roundup’s labeling, it
was obligated by FIFRA’s misbranding requirements to
either stop selling Roundup or willingly pay the damages
and penalties that attach to selling a pesticide that Durnell’s jury determined to be misbranded.
A. Neither FIFRA Nor Its Implementing Regulations
Prevent Monsanto From Adding A Cancer Warning To
Roundup’s Labeling
Monsanto’s impossibility-preemption argument hinges on its assertion that “federal law” requires it to use
labels identical to those EPA approved during the registration process.37 Pet. Br. 35. But nothing in FIFRA or
36. Bartlett, 570 U.S. at 488.
37. Pet. Br. 2 (“Monsanto could not provide the warnings Missouri
law requires without rendering Roundup misbranded under federal law.”); id. at 30 (“FIFRA makes it illegal to distribute a pesticide with health warnings other than those approved by EPA.”);
see also id. at 8–9, 21–22, 25–26, 33, 35, 44–45.
38
EPA regulations prevents Monsanto from unilaterally
adding cancer warnings to Roundup’s labeling.
1. 7 U.S.C. § 136j(a)(1)(B) Prevents Manufacturers
From Altering The Statement Of Claims Made For
A Pesticide, Not Its Labeling
Monsanto falsely asserts that 7 U.S.C. § 136j(a)(1)(B)
prohibits post-registration label changes. Pet. Br. 25
(“FIFRA makes it illegal to distribute a pesticide with labeling substantially different from the EPA-approved label. 7 U.S.C. § 136j(a)(1)(B).”). What the provision actually prohibits is the distribution or sale of:
any registered pesticide if any claims made for
it as a part of its distribution or sale substantially differ from any claims made for it as a
part of the statement required in connection
with its registration under section 136a of this
title;
7 U.S.C. § 136j(a)(1)(B) (emphases added). The “claims
made” in the registration statement are distinct from the
label:
Each applicant for registration of a pesticide
shall file with the Administrator a statement
which includes — …
(C) a complete copy of the labeling of the pesticide, a statement of all claims to be made for it,
and any directions for its use;
7 U.S.C. § 136a(c)(1)(C) (emphases added). So the “labeling,” the “statement of all claims to be made for” the pesticide, and the “directions for its use” are different pieces
of information that an applicant submits during the regis-
39
tration process. Yet section 136j(a)(1)(B) locks into place
only the statement of claims made for the pesticide, leaving manufacturers free to change the “labeling” and the
“directions for its use.” Equating the statement of claims
with the label is nothing short of misdirection.
Monsanto also claims that including a cancer warning
on Roundup labels would violate FIFRA’s misbranding
provisions by making those labels “false or misleading”
under 7 U.S.C. § 136(q)(1)(A). Pet. Br. 2. That defense was
available to Monsanto, but the jury disagreed. It is for jurors and judges, not Monsanto, to resolve the factual
question of whether a cancer warning would violate
FIFRA’s misbranding provisions. And in all events, Monsanto can easily provide an adequate cancer warning that
is irrefutably truthful and not misleading, such as: “The
International Agency for Research on Cancer considers
glyphosate probably carcinogenic to humans.” Nothing in
FIFRA prohibits such a warning, and nothing in state law
required a particularly worded warning so long as it was
adequate. See Wyeth v. Levine, 555 U.S. 555, 565 (2009).
2. EPA’s Regulations Do Not And Cannot Prevent
Monsanto From Adding A Cancer Warning To
Roundup’s Labeling
Monsanto also cites EPA regulations that purport to
prohibit unilateral modifications to the label of a registered pesticide. See 40 C.F.R. §§ 152.44, 152.46. But regulations cannot prohibit what the statute allows under
Loper Bright, and EPA cannot concoct a prohibition on
label modifications when 7 U.S.C. § 136j(a)(1)(B) bars
manufacturers from altering only the claims made for the
pesticide. Nothing else in FIFRA prevents a manufacturer from unilaterally changing the registered label. In
40
fact, complying with the misbranding provision will often
require that the manufacturer either amend the label or
cease selling the pesticide altogether. EPA lacks statutory
authority to impose a preclearance requirement for label
modifications, especially when a manufacturer is seeking
to add warnings or caution statements that are “necessary … to protect health and the environment” or to avoid
rendering the label “false or misleading.” 7 U.S.C.
§ 136(q)(1)(G), (A).
Even assuming the regulations are valid, these EPA
rules are no help to Monsanto because they allow Monsanto to unilaterally add cancer warnings so long as it
avoids placing the warning in certain sections of the label.
And the versions of these rules in effect when Durnell
first started using Roundup were even clearer in permitting unilateral changes.
Under 40 C.F.R. § 152.46(a)(1), EPA may permit “minor” label modifications to proceed through notification
without the need for EPA approval. EPA lists the permissible unilateral changes in its “Pesticide Registration Notices” or “PRNs.” In 1995, EPA issued PRN 95-02, which
provides that “advisory statements,” including “those related to precautions,” “may be added or revised via notification.”38 In 1998, EPA issued PRN 98-10, which reaffirmed that PRN 95-02’s rule on “advisory statements …
related to precautions” remains the PRN that manufacturers should “continue to follow.”39 This PRN also made
clear that “other revisions” to the label were permissible
38. EPA, Pesticide Registration Notice 95-02, 3 (May 31, 1995),
https://perma.cc/C8XM-7NAZ.
39. EPA, Pesticide Registration Notice 98-10, 3 (Oct. 22, 1998),
https://perma.cc/ZK8Z-2NNM.
41
if they are “consistent with 40 CFR Part 156” and “involve
no change” to certain sections of the label, e.g., the “ingredients statement,” “First Aid statement,” or “precautionary statements.”40
It was not until 2000 — four years after Durnell began
using Roundup — that EPA issued PRN 2000-5, which
states that “registrants may no longer add or change advisory labeling statements to existing products by notification as previously permitted by PR Notices 95-2 and 9810.”41 But PRN 2000-5 made no adjustment to a manufacturer’s ability to change other sections of the Roundup label unilaterally. Id.
Durnell used Roundup for more than 20 years. For the
first four years of that use — 1996 to 2000 — Monsanto
could have unilaterally added a cancer warning in the “advisory statements” section of the Roundup label. And for
the remaining years of use, unilateral warnings could still
be added so long as the manufacturer placed them in the
proper section of the label.
Monsanto knows full well that this sort of label change
was permissible. Its parent company Bayer notified EPA
in 2012 that it had unilaterally added a cancer warning to
the very end of one of its pesticide labels.42 And EPA con40. Id. at 8.
41. EPA, Pesticides; Guidance for Pesticide Registrants on Mandatory and Advisory Labeling Statements, 65 Fed. Reg. 31,313,
31,314 (May 17, 2000).
42. See Letter from Larry R. Hodges, Bayer CropScience, to EPA,
Office of Pesticide Programs 4 (Nov. 29, 2012), https://perma.cc/
X64N-WX5F (“As allowed by PR Notice 98-10, we are notifying
the Agency of a minor labeling amendment for LARVIN Technical (EPA Reg. No. 264-343). As required by California Proposition 65, the following statement was added to label, ‘This pro(continued…)
42
firmed that Bayer was allowed to make this unilateral
change.43 It cannot be impossible to do what has already
been done.
Monsanto’s fallback argument is to assert that EPA
would have vetoed the change, and it claims to have produced “clear evidence” that this would have happened.
Pet. Br. 48 (citing Albrecht, 587 U.S. at 314). But this
“clear evidence” defense comes from cases interpreting
the Food Drug and Cosmetic Act (FDCA), which requires
manufacturers to submit unilateral label changes to FDA
and gives the agency authority to reject them even after
the manufacturer has made the changes. 21 C.F.R.
§ 314.70(c)(1), (c)(7). With the agency empowered to veto
a label change, this Court held that a manufacturer can
establish preemption if it proves by “clear evidence” that
FDA would have walked back a stronger warning. Albrecht, 587 U.S. at 315; but see id. at 321 (Thomas, J., concurring) (“[N]either agency musings nor hypothetical future rejections constitute pre-emptive ‘Laws’ under the
Supremacy Clause.”).
That rationale does not apply here. FIFRA freely allows manufacturers to make unilateral changes to their
labels. See pp. 38–39, supra. So do EPA’s regulations. And
neither FIFRA nor EPA’s regulations establish any mechanism for EPA to force a manufacturer to undo a uniduct contains a chemical known to the state of California to cause
cancer.’ ”)
43. See Letter from Jennifer Gaines, EPA, Office of Pesticide Programs, to Larry Hodges, Bayer CropScience 2 (Dec. 17, 2012),
https://perma.cc/X64N-WX5F (“The Registration Division (RD)
has conducted a review of this request for its applicability under
PRN 98-10 and finds that the action(s) requested fall within the
scope of PRN 98-10.”).
43
lateral change. That Monsanto thinks it has adduced
“clear evidence” that EPA dislikes a hypothetical cancer
warning that the company never added to its label says
nothing about whether it was impossible to provide this
warning to Durnell.
And even if this Court were to import the clear-evidence regime into FIFRA, Monsanto has not satisfied it.
Monsanto never once asked EPA to approve a Roundup
label that warns about the risk of cancer. But to establish
clear evidence, Monsanto must “show that it fully informed the [agency] of the justifications for the warning
required by state law and that the [agency], in turn, informed the … manufacturer that the [agency] would not
approve changing the [product’s] label to include that
warning.” Albrecht, 587 U.S. at 314. Monsanto claims that
EPA sent letters to other manufacturers suggesting that
it no longer agreed with their cancer warnings,44 but none
of that matters under Albrecht. Perhaps Monsanto could
have made a more persuasive case. It cannot throw up its
hands and declare “impossibility” when it did not deign to
try. Albrecht, 587 U.S. at 314.
B. Durnell’s Claim Is Not Preempted Even If Monsanto
Could Not Change The Label
Even accepting the (false) premise that Monsanto was
forbidden to change the EPA-approved label, that still
does not establish an implied-preemption defense. Monsanto is arguing impossibility, and the only way that Missouri law can be “impossible” for Monsanto to comply with
is by characterizing the relevant state-law duty as a duty
to change the label.
44. Pet. Br. 48.
44
But that is simply not the relevant duty under state or
federal law. The duty under federal law is to not sell a misbranded pesticide. See 7 U.S.C. § 136j(a)(1)(E). The duty
under state law is to not sell a pesticide that has an inadequate or misleading label. Racer, 629 S.W.2d at 395.
There cannot be an “impossibility” conflict between those
two duties.
It is true enough that this Court has held that a party
cannot be required to cease activity altogether as an alternative to complying with a state duty that contradicts
federal law. If federal law commands “drive on the right”
and Missouri law proclaims “drive on the left,” a plaintiff
cannot avoid preemption by asserting that the defendant
should have ceased driving altogether. See Transcript of
Oral Argument at 46–47, Bartlett, 570 U.S. 472. Neither
sovereign was attempting to force drivers off the road.
Each simply selected incompatible modes of driving.
While not driving at all is both possible and a way to avoid
liability, “physical impossibility” is not always the test for
preemption. See Bartlett, 570 U.S. at 488.
None of that applies when federal and state law both
require a party to cease acting. In that circumstance, cessation is not some pettifogger’s excuse to leave in place
conflicting legal commands. It is instead the only way to
ensure that both commands are obeyed. That is why Bartlett made clear that it was not addressing claims “that parallel the federal misbranding statute” under the FDCA,
which, like FIFRA, compels drugmakers to stop selling
misbranded pharmaceuticals. Id. at 487 n.4 (citing Bates,
544 U.S. at 447). The Court cited Bates because that case
already applied the same logic under FIFRA. Bates affirmed that states have the complete prerogative to re-
45
quire a manufacturer to stop selling a pesticide for any
reason, to say nothing of reasons that parallel federal law.
Bates, 544 U.S. at 450 (“States may ban or restrict the
uses of pesticides that EPA has approved.”).
Settled or not, the question is straightforward.
FIFRA unambiguously requires Monsanto to stop selling
a misbranded pesticide. Missouri law requires the exact
same thing. Where complying with “the supreme law of
the land” requires cessation, Monsanto must comply with
both state and federal law by either withdrawing Roundup from the market or willingly accepting the risk that it
must pay individual tort victims the damages that juries
award them.45
Monsanto, of course, remains free to argue in future
cases by future plaintiffs that Roundup is not misbranded
and can continue to be sold. By its nature, the judicial power binds only the parties to the case, so the jury verdict
and judicial decisions below (and here) bind Monsanto
only vis-à-vis Durnell. They do not have universal effect.
Cf. Trump v. CASA, Inc., 606 U.S. 831 (2025). State and
federal legal duties — stop selling if the pesticide is inadequately or misleadingly labeled — will remain completely
parallel in those future actions. But future juries may accept Monsanto’s presentation of the facts and conclude
that selling Roundup did not breach any state and federal
obligations.
45. Monsanto never deals with this fact because its entire argument
is premised on the idea that Roundup cannot possibly be “misbranded” under FIFRA because EPA approved its label during
the registration process. See pp. 21–33, supra.
46
III. MONSANTO’S PREEMPTION ARGUMENTS FIND
NO SUPPORT IN THIS COURT’S CASE LAW
Monsanto’s preemption arguments are incompatible
with this Court’s precedents.
A. Monsanto’s Preemption Arguments Are Incompatible
With Bates
Monsanto’s preemption arguments would have required a finding of preemption in Bates. The Strongarm
label, which failed to warn Texas peanut farmers that it
would destroy their crops, had been approved by EPA
during the registration process. Bates, 544 U.S. at 434–35.
So if “the label is the law!,” as Monsanto insists throughout its brief,46 then any failure-to-warn claim predicated
on an EPA-approved label is preempted. The Court obviously did not take that view in Bates; it allowed the failureto-warn claim to proceed.
Monsanto and the Solicitor General attempt to circumvent Bates by observing that EPA never actually weighed
in on the efficacy of Strongarm or the accuracy of the labeling statements that recommended its use for peanut
crops. Pet. Br. 32, SG Br. 27. But the outcome in Bates did
not in any way depend on that fact. 544 U.S. at 438 (“Because it is unlawful under the statute to sell a pesticide
that is registered but nevertheless misbranded, manufacturers have a continuing obligation to adhere to FIFRA’s
labeling requirements.”). That is because nothing in
FIFRA’s text turns on whether the Administrator ignored
46. Pet. Br. 8, 26, 45.
47
or thoughtfully weighed a scientific question.47 Id. at 448
(“[A]lthough FIFRA does not provide a federal remedy to
farmers and others who are injured as a result of a manufacturer’s violation of FIFRA’s labeling requirements,
nothing in § 136v(b) precludes States from providing such
a remedy.” (emphasis added)).
Monsanto’s effort to distinguish Bates is also incompatible with its sweeping statements on the supposed
sanctity of the EPA-approved label that appear throughout its brief. Instead of proclaiming that “the label is the
law!”, Monsanto should appropriately hedge this slogan
given its desire to accommodate Bates. Perhaps it could
try: “The label is the law, but only if EPA actually considered and affirmatively agrees with the particular statements that appear on the label!” But then Monsanto
would have to explain what would happen if a future Administrator determines that glyphosate does indeed cause
cancer. Could Durnell then reopen his case under the
state-law equivalent of Rule 60(b)? And would EPA’s new
factual determination entitle Durnell (and similarly situated plaintiffs) to a directed verdict? Cf. National Cable &
Telecommunications Association v. Brand X Internet
Services, 545 U.S. 967 (2005). Modified once again, Monsanto’s mantra must really be: “The label is the law, so
long as EPA has actually considered and blessed its contents, but only for so long as EPA has not changed its
47. The argument fails on its own terms. EPA has never considered
whether all of the ingredients in Roundup — including surfactants, ethylene oxide, and 1, 4-Dioxane — combined with glyphosate can cause cancer. And it has never considered Durnell’s experts’ interpretations and analysis of the scientific evidence.
48
mind!” That catchphrase has little to recommend it. And
it is inconsistent with Bates, to say nothing of FIFRA.
Bates also shuts down Monsanto’s fears that civil-jury
enforcement of FIFRA’s labeling standards will produce
a “crazy quilt”48 of conflicting obligations. Bates considered and rejected this idea both as an empirical matter
and as a reason to find preemption. Bates, 544 U.S. at 451–
52 (“Dow and the United States exaggerate the disruptive
effects of using common-law suits to enforce the prohibition on misbranding.”) And although Bates acknowledges
that “properly instructed juries might on occasion reach
contrary conclusions on a similar issue of misbranding,” it
specifically holds that the prospect of divergent verdicts
is no reason to prevent state juries from enforcing “state
rules that are fully consistent with federal requirements.”
Id. at 452. Yesterday’s “crazy quilts” are today’s “patchworks” and “cacophonies,”49 but changing the nomenclature does not change Bates’s holding. Whatever discordant noises Monsanto fears will emanate from jury boxes,
Bates does not permit the company to take the interpretation and application of the misbranding standard from
the judiciary.
Bates poses an even bigger problem for Monsanto’s
implied-preemption argument. If Monsanto is right to
claim that “federal law” prohibits manufacturers from
changing EPA-approved labels without permission, then
Dow would have been forbidden to change its Strongarm
labels absent prior EPA approval. So Dow would have
been in the same position that Monsanto claims to be in.
And although Dow eventually obtained EPA approval to
48. Bates, 544 U.S. at 448, 451.
49. Pet. Br. at 5, 50, 51.
49
include the desired warning,50 Monsanto insists that is irrelevant. Pet Br. 44 (“The question for ‘impossibility’ is
whether the private party could independently do under
federal law what state law requires of it.” (cleaned up)).
Bates would have to come out the other way if this Court
accepts Monsanto’s impossibility-preemption argument.
B. The Court’s Decision In Riegel v. Medtronic, Inc. Is
Inapposite
Monsanto and the Solicitor General try to analogize
this case to Riegel v. Medtronic, Inc., 552 U.S. 312 (2008),
which held that a similarly worded express-preemption
provision blocked a state-law failure-to-warn claim over a
medical device that had received premarket approval
from FDA. But Riegel is inapposite for two reasons. First,
the Court in Riegel held that the Medical Device Amendments banned manufacturers from altering an FDAapproved device or its labeling absent FDA permission.
See id. at 319 (citing 21 U.S.C. § 360e(d)(5)(A)(i)). Nothing
in FIFRA or its implementing regulations prohibits Monsanto from adding a cancer warning to its Roundup labels;
indeed, the EPA regulations explicitly allow Monsanto to
add this warning without seeking EPA approval. See pp.
39–42, supra.
Second, no one in Riegel even attempted to argue that
the FDA-approved medical device violated the separate
statutory misbranding prohibitions in the FDCA. See 21
U.S.C. § 331 (“The following acts and the causing thereof
are prohibited: (a) The introduction or delivery for introduction into interstate commerce of any … device … that
is adulterated or misbranded.”). The plaintiff in Riegel
50. Bates, 544 U.S. at 435.
50
hinged her entire case on the contentions that: (1) FDA’s
premarket approval of a medical device failed to impose
“requirements” within the meaning of the statute’s express-preemption provision, 21 U.S.C. § 360k(a)(1); and
(2) state common-law duties fail to qualify as “requirements.” See Riegel, 552 U.S. at 322–25.
Durnell concedes51 that Missouri’s failure-to-warn law
imposes some “requirements for labeling” within the
meaning of 7 U.S.C. § 136v(b). And Durnell — unlike Riegel — is arguing that Missouri may impose failure-towarn liability on Monsanto because the jury could reasonably conclude that Roundup’s labeling violates FIFRA’s
prohibition on selling misbranded pesticides. Riegel is no
help at all to Monsanto because it expressly refused to address a situation in which a plaintiff claims that a statelaw failure to warn also violates the misbranding prohibitions enshrined in federal law.
***
Monsanto’s brief is a 53-page non sequitur. EPA’s belief that Roundup’s labels comply with FIFRA’s misbranding provisions means nothing when Loper Bright
gives courts rather than agencies the authority to interpret and apply those provisions. EPA’s repeated pronouncements that glyphosate is noncarcinogenic are likewise irrelevant unless this Court is prepared to extend the
doctrine of nonmutual collateral estoppel to an agency’s
factual assertions. And Monsanto’s policy arguments for
why EPA should be given delegated power belong in its
lobbying materials for congressmen and senators, not in
a Supreme Court brief. Monsanto has forfeited any claim
51. See Bates, 544 U.S. at 443, 446; Riegel, 552 U.S. at 323–25.
51
that Missouri tort law adds to or differs from FIFRA’s requirements by failing to request a Bates instruction at
trial, and there is no reason to believe that a cost-benefit
analysis instruction would have affected the jury’s verdict
in any way.
Monsanto’s claims that FIFRA and EPA’s regulations
prohibit it from adding a cancer warning to Roundup’s labels are untrue. And even if federal law prevented Monsanto from adding a cancer warning to Roundup’s EPAapproved labels, FIFRA would still prohibit Monsanto
from distributing or selling Roundup if the judiciary finds
its labels misleading or inadequate under 7 U.S.C.
§ 136(q) or state tort law. Monsanto cannot escape the fact
that Loper Bright empowers the judiciary and not EPA to
interpret and apply FIFRA’s misbranding prohibitions,
and it cannot establish express or implied preemption by
ignoring the statutory delegation issue and begging the
question throughout its brief.
52
CONCLUSION
The judgment of the Missouri Court of Appeals should
be affirmed.
Respectfully submitted.
JONATHAN F. MITCHELL
Mitchell Law PLLC
111 Congress Avenue
Suite 400
Austin, Texas 78701
(512) 686-3940
jonathan@mitchell.law
T. ROE FRAZER II
THOMAS ROE FRAZER III
JAMES GRANT LABAR
R. PRESCOTT SIFTON JR.
Frazer PLC
30 Burton Hills Boulevard
Suite 450
Nashville, Tennessee 37215
(615) 647-6464
March 25, 2026
ASHLEY C. KELLER
Counsel of Record
JOHN JAMES SNIDOW
Keller Postman LLC
1101 Connecticut Avenue NW
Suite 1100
Washington, D.C. 20036
(202) 918-1123
ack@kellerpostman.com
JAMES G. ONDER
W. WYLIE BLAIR
GREGORY J. PALS
MARK E. BERNS
OnderLaw LLC
110 East Lockwood Avenue
St. Louis, Missouri 63119
(314) 963-9000
APPENDIX
TABLE OF CONTENTS
7 U.S.C. § 136(q) .................................................................. 1a
7 U.S.C. § 136(bb) ................................................................ 4a
7 U.S.C. § 136a ..................................................................... 5a
7 U.S.C. § 136j(a)(1) .......................................................... 40a
7 U.S.C. § 136v(a)–(b) ....................................................... 44a
7 U.S.C. § 136w(a)–(c) ....................................................... 45a
40 C.F.R. § 152.44 .............................................................. 49a
40 C.F.R. § 152.46 .............................................................. 51a
Pesticide (PR) Notice 95-2 ............................................... 53a
Pesticide (PR) Notice 98-10 ............................................. 73a
Pesticide (PR) Notice 2000-15 ....................................... 103a
Letter from Larry R. Hodges, Bayer CropScience, to EPA, Office of Pesticide Programs
(Nov. 29, 2012) ............................................................ 113a
Letter from Jennifer Gaines, EPA, Office of
Pesticide Programs, to Larry Hodges, Bayer
CropScience (Dec. 17, 2012) ..................................... 115a
1a
TITLE 7 — AGRICULTURE
SUBCHAPTER II — ENVIRONMENTAL
PESTICIDE CONTROL
§ 136. Definitions
For purposes of this subchapter — . . .
(q) Misbranded
(1) A pesticide is misbranded if —
(A) its labeling bears any statement, design, or
graphic representation relative thereto or to its ingredients which is false or misleading in any particular;
(B) it is contained in a package or other container
or wrapping which does not conform to the standards
established by the Administrator pursuant to section
136w(c)(3) of this title;
(C) it is an imitation of, or is offered for sale under
the name of, another pesticide;
(D) its label does not bear the registration number
assigned under section 136e of this title to each establishment in which it was produced;
(E) any word, statement, or other information required by or under authority of this subchapter to
appear on the label or labeling is not prominently
placed thereon with such conspicuousness (as compared with other words, statements, designs, or
graphic matter in the labeling) and in such terms as
to render it likely to be read and understood by the
ordinary individual under customary conditions of
purchase and use;
(F) the labeling accompanying it does not contain
directions for use which are necessary for effecting
2a
the purpose for which the product is intended and if
complied with, together with any requirements imposed under section 136a(d) of this title, are adequate
to protect health and the environment;
(G) the label does not contain a warning or caution
statement which may be necessary and if complied
with, together with any requirements imposed under
section 136a(d) of this title, is adequate to protect
health and the environment; or
(H) in the case of a pesticide not registered in accordance with section 136a of this title and intended
for export, the label does not contain, in words prominently placed thereon with such conspicuousness (as
compared with other words, statements, designs, or
graphic matter in the labeling) as to render it likely
to be noted by the ordinary individual under customary conditions of purchase and use, the following:
“Not Registered for Use in the United States of
America”.
(2) A pesticide is misbranded if —
(A) the label does not bear an ingredient statement
on that part of the immediate container (and on the
outside container or wrapper of the retail package, if
there be one, through which the ingredient statement
on the immediate container cannot be clearly read)
which is presented or displayed under customary
conditions of purchase, except that a pesticide is not
misbranded under this subparagraph if —
(i) the size or form of the immediate container, or
the outside container or wrapper of the retail package, makes it impracticable to place the ingredient
statement on the part which is presented or dis-
3a
played under customary conditions of purchase;
and
(ii) the ingredient statement appears prominently
on another part of the immediate container, or outside container or wrapper, permitted by the Administrator;
(B) the labeling does not contain a statement of the
use classification under which the product is registered;
(C) there is not affixed to its container, and to the
outside container or wrapper of the retail package, if
there be one, through which the required information
on the immediate container cannot be clearly read, a
label bearing —
(i) the name and address of the producer, registrant, or person for whom produced;
(ii) the name, brand, or trademark under which
the pesticide is sold;
(iii) the net weight or measure of the content, except that the Administrator may permit reasonable
variations; and
(iv) when required by regulation of the Administrator to effectuate the purposes of this subchapter,
the registration number assigned to the pesticide
under this subchapter, and the use classification;
and
(D) the pesticide contains any substance or substances in quantities highly toxic to man, unless the
label shall bear, in addition to any other matter required by this subchapter —
(i) the skull and crossbones;
(ii) the word “poison” prominently in red on a
background of distinctly contrasting color; and
4a
(iii) a statement of a practical treatment (first aid
or otherwise) in case of poisoning by the pesticide.
...
(bb) Unreasonable adverse effects on the environment
The term “unreasonable adverse effects on the environment” means (1) any unreasonable risk to man or the
environment, taking into account the economic, social,
and environmental costs and benefits of the use of any
pesticide, or (2) a human dietary risk from residues that
result from a use of a pesticide in or on any food inconsistent with the standard under section 346a of title 21.
The Administrator shall consider the risks and benefits
of public health pesticides separate from the risks and
benefits of other pesticides. In weighing any regulatory
action concerning a public health pesticide under this
subchapter, the Administrator shall weigh any risks of
the pesticide against the health risks such as the diseases transmitted by the vector to be controlled by the pesticide.
5a
§ 136a. Registration of pesticides
(a) Requirement of registration
Except as provided by this subchapter, no person in
any State may distribute or sell to any person any pesticide that is not registered under this subchapter. To the
extent necessary to prevent unreasonable adverse effects on the environment, the Administrator may by regulation limit the distribution, sale, or use in any State of
any pesticide that is not registered under this subchapter and that is not the subject of an experimental use
permit under section 136c of this title or an emergency
exemption under section 136p of this title.
(b) Exemptions
A pesticide which is not registered with the Administrator may be transferred if —
(1) the transfer is from one registered establishment
to another registered establishment operated by the
same producer solely for packaging at the second establishment or for use as a constituent part of another
pesticide produced at the second establishment; or
(2) the transfer is pursuant to and in accordance with
the requirements of an experimental use permit.
(c) Procedure for registration
(1) Statement required
Each applicant for registration of a pesticide shall file
with the Administrator a statement which includes—
(A) the name and address of the applicant and of
any other person whose name will appear on the labeling;
(B) the name of the pesticide;
6a
(C) a complete copy of the labeling of the pesticide,
a statement of all claims to be made for it, and any directions for its use;
(D) the complete formula of the pesticide;
(E) a request that the pesticide be classified for
general use or for restricted use, or for both; and
(F) except as otherwise provided in paragraph
(2)(D), if requested by the Administrator, a full description of the tests made and the results thereof
upon which the claims are based, or alternatively a citation to data that appear in the public literature or
that previously had been submitted to the Administrator and that the Administrator may consider in accordance with the following provisions:
(i) With respect to pesticides containing active ingredients that are initially registered under this
subchapter after September 30, 1978, data submitted to support the application for the original registration of the pesticide, or an application for an
amendment adding any new use to the registration
and that pertains solely to such new use, shall not,
without the written permission of the original data
submitter, be considered by the Administrator to
support an application by another person during a
period of ten years following the date the Administrator first registers the pesticide, except that such
permission shall not be required in the case of defensive data.
(ii) The period of exclusive data use provided under clause (i) shall be extended 1 additional year for
each 3 minor uses registered after August 3, 1996,
and within 7 years of the commencement of the exclusive use period, up to a total of 3 additional years
7a
for all minor uses registered by the Administrator
if the Administrator, in consultation with the Secretary of Agriculture, determines that, based on information provided by an applicant for registration
or a registrant, that —
(I) there are insufficient efficacious alternative
registered pesticides available for the use;
(II) the alternatives to the minor use pesticide
pose greater risks to the environment or human
health;
(III) the minor use pesticide plays or will play a
significant part in managing pest resistance; or
(IV) the minor use pesticide plays or will play a
significant part in an integrated pest management
program.
The registration of a pesticide for a minor use on a
crop grouping established by the Administrator
shall be considered for purposes of this clause 1 minor use for each representative crop for which data
are provided in the crop grouping. Any additional
exclusive use period under this clause shall be modified as appropriate or terminated if the registrant
voluntarily cancels the product or deletes from the
registration the minor uses which formed the basis
for the extension of the additional exclusive use period or if the Administrator determines that the
registrant is not actually marketing the product for
such minor uses.
(iii) Except as otherwise provided in clause (i),
with respect to data submitted after December 31,
1969, by an applicant or registrant to support an
application for registration, experimental use permit, or amendment adding a new use to an existing
8a
registration, to support or maintain in effect an existing registration, or for reregistration, the Administrator may, without the permission of the original
data submitter, consider any such item of data in
support of an application by any other person
(hereinafter in this subparagraph referred to as the
‘‘applicant’’) within the fifteen-year period following
the date the data were originally submitted only if
the applicant has made an offer to compensate the
original data submitter and submitted such offer to
the Administrator accompanied by evidence of delivery to the original data submitter of the offer.
The terms and amount of compensation may be
fixed by agreement between the original data submitter and the applicant, or, failing such agreement,
binding arbitration under this subparagraph. If, at
the end of ninety days after the date of delivery to
the original data submitter of the offer to compensate, the original data submitter and the applicant
have neither agreed on the amount and terms of
compensation nor on a procedure for reaching an
agreement on the amount and terms of compensation, either person may initiate binding arbitration
proceedings by requesting the Federal Mediation
and Conciliation Service to appoint an arbitrator
from the roster of arbitrators maintained by such
Service. The procedure and rules of the Service
shall be applicable to the selection of such arbitrator and to such arbitration proceedings, and the
findings and determination of the arbitrator shall
be final and conclusive, and no official or court of
the United States shall have power or jurisdiction
to review any such findings and determination, ex-
9a
cept for fraud, misrepresentation, or other misconduct by one of the parties to the arbitration or the
arbitrator where there is a verified complaint with
supporting affidavits attesting to specific instances
of such fraud, misrepresentation, or other misconduct. The parties to the arbitration shall share
equally in the payment of the fee and expenses of
the arbitrator. If the Administrator determines that
an original data submitter has failed to participate
in a procedure for reaching an agreement or in an
arbitration proceeding as required by this subparagraph, or failed to comply with the terms of an
agreement or arbitration decision concerning compensation under this subparagraph, the original data submitter shall forfeit the right to compensation
for the use of the data in support of the application.
Notwithstanding any other provision of this subchapter, if the Administrator determines that an
applicant has failed to participate in a procedure for
reaching an agreement or in an arbitration proceeding as required by this subparagraph, or failed
to comply with the terms of an agreement or arbitration decision concerning compensation under
this subparagraph, the Administrator shall deny
the application or cancel the registration of the pesticide in support of which the data were used without further hearing. Before the Administrator takes
action under either of the preceding two sentences,
the Administrator shall furnish to the affected person, by certified mail, notice of intent to take action
and allow fifteen days from the date of delivery of
the notice for the affected person to respond. If a
registration is denied or canceled under this sub-
10a
paragraph, the Administrator may make such order
as the Administrator deems appropriate concerning
the continued sale and use of existing stocks of such
pesticide. Registration action by the Administrator
shall not be delayed pending the fixing of compensation.
(iv) After expiration of any period of exclusive use
and any period for which compensation is required
for the use of an item of data under clauses (i), (ii),
and (iii), the Administrator may consider such item
of data in support of an application by any other
applicant without the permission of the original data submitter and without an offer having been received to compensate the original data submitter
for the use of such item of data.
(v) The period of exclusive use provided under
clause (ii) shall not take effect until 1 year after August 3, 1996, except where an applicant or registrant is applying for the registration of a pesticide
containing an active ingredient not previously registered.
(vi) With respect to data submitted after August
3, 1996, by an applicant or registrant to support an
amendment adding a new use to an existing registration that does not retain any period of exclusive
use, if such data relates solely to a minor use of a
pesticide, such data shall not, without the written
permission of the original data submitter, be considered by the Administrator to support an application for a minor use by another person during the
period of 10 years following the date of submission
of such data. The applicant or registrant at the time
the new minor use is requested shall notify the Ad-
11a
ministrator that to the best of their knowledge the
exclusive use period for the pesticide has expired
and that the data pertaining solely to the minor use
of a pesticide is eligible for the provisions of this
paragraph. If the minor use registration which is
supported by data submitted pursuant to this subsection is voluntarily canceled or if such data are
subsequently used to support a nonminor use, the
data shall no longer be subject to the exclusive use
provisions of this clause but shall instead be considered by the Administrator in accordance with the
provisions of clause (i), as appropriate.
(G) If the applicant is requesting that the registration or amendment to the registration of a pesticide
be expedited, an explanation of the basis for the request must be submitted, in accordance with paragraph (10) of this subsection.
(2) Data in support of registration
(A) In general
The Administrator shall publish guidelines specifying the kinds of information which will be required to
support the registration of a pesticide and shall revise such guidelines from time to time. If thereafter
the Administrator requires any additional kind of information under subparagraph (B) of this paragraph,
the Administrator shall permit sufficient time for applicants to obtain such additional information. The
Administrator, in establishing standards for data requirements for the registration of pesticides with respect to minor uses, shall make such standards commensurate with the anticipated extent of use, pattern
of use, the public health and agricultural need for
such minor use, and the level and degree of potential
12a
beneficial or adverse effects on man and the environment. The Administrator shall not require a person to submit, in relation to a registration or reregistration of a pesticide for minor agricultural use under
this subchapter, any field residue data from a geographic area where the pesticide will not be registered for such use. In the development of these
standards, the Administrator shall consider the economic factors of potential national volume of use, extent of distribution, and the impact of the cost of
meeting the requirements on the incentives for any
potential registrant to undertake the development of
the required data. Except as provided by section
136h of this title, within 30 days after the Administrator registers a pesticide under this subchapter the
Administrator shall make available to the public the
data called for in the registration statement together
with such other scientific information as the Administrator deems relevant to the Administrator’s decision.
(B) Additional data
(i) If the Administrator determines that additional
data are required to maintain in effect an existing
registration of a pesticide, the Administrator shall
notify all existing registrants of the pesticide to which
the determination relates and provide a list of such
registrants to any interested person.
(ii) Each registrant of such pesticide shall provide
evidence within ninety days after receipt of notification that it is taking appropriate steps to secure the
additional data that are required. Two or more registrants may agree to develop jointly, or to share in the
cost of developing, such data if they agree and advise
13a
the Administrator of their intent within ninety days
after notification. Any registrant who agrees to share
in the cost of producing the data shall be entitled to
examine and rely upon such data in support of
maintenance of such registration. The Administrator
shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures
prescribed by clause (iv) if a registrant fails to comply with this clause.
(iii) If, at the end of sixty days after advising the
Administrator of their agreement to develop jointly,
or share in the cost of developing, data, the registrants have not further agreed on the terms of the
data development arrangement or on a procedure for
reaching such agreement, any of such registrants
may initiate binding arbitration proceedings by requesting the Federal Mediation and Conciliation Service to appoint an arbitrator from the roster of arbitrators maintained by such Service. The procedure
and rules of the Service shall be applicable to the selection of such arbitrator and to such arbitration proceedings, and the findings and determination of the
arbitrator shall be final and conclusive, and no official
or court of the United States shall have power or jurisdiction to review any such findings and determination, except for fraud, misrepresentation, or other
misconduct by one of the parties to the arbitration or
the arbitrator where there is a verified complaint
with supporting affidavits attesting to specific instances of such fraud, misrepresentation, or other
misconduct. All parties to the arbitration shall share
equally in the payment of the fee and expenses of the
arbitrator. The Administrator shall issue a notice of
14a
intent to suspend the registration of a pesticide in accordance with the procedures prescribed by clause
(iv) if a registrant fails to comply with this clause.
(iv) Notwithstanding any other provision of this
subchapter, if the Administrator determines that a
registrant, within the time required by the Administrator, has failed to take appropriate steps to secure
the data required under this subparagraph, to participate in a procedure for reaching agreement concerning a joint data development arrangement under this
subparagraph or in an arbitration proceeding as required by this subparagraph, or to comply with the
terms of an agreement or arbitration decision concerning a joint data development arrangement under
this subparagraph, the Administrator may issue a notice of intent to suspend such registrant’s registration
of the pesticide for which additional data is required.
The Administrator may include in the notice of intent
to suspend such provisions as the Administrator
deems appropriate concerning the continued sale and
use of existing stocks of such pesticide. Any suspension proposed under this subparagraph shall become
final and effective at the end of thirty days from receipt by the registrant of the notice of intent to suspend, unless during that time a request for hearing is
made by a person adversely affected by the notice or
the registrant has satisfied the Administrator that
the registrant has complied fully with the requirements that served as a basis for the notice of intent to
suspend. If a hearing is requested, a hearing shall be
conducted under section 136d(d) of this title. The only
matters for resolution at that hearing shall be whether the registrant has failed to take the action that
15a
served as the basis for the notice of intent to suspend
the registration of the pesticide for which additional
data is required, and whether the Administrator’s determination with respect to the disposition of existing
stocks is consistent with this subchapter. If a hearing
is held, a decision after completion of such hearing
shall be final. Notwithstanding any other provision of
this subchapter, a hearing shall be held and a determination made within seventy-five days after receipt
of a request for such hearing. Any registration suspended under this subparagraph shall be reinstated
by the Administrator if the Administrator determines
that the registrant has complied fully with the requirements that served as a basis for the suspension
of the registration.
(v) Any data submitted under this subparagraph
shall be subject to the provisions of paragraph (1)(D).
Whenever such data are submitted jointly by two or
more registrants, an agent shall be agreed on at the
time of the joint submission to handle any subsequent
data compensation matters for the joint submitters of
such data.
(vi) Upon the request of a registrant the Administrator shall, in the case of a minor use, extend the
deadline for the production of residue chemistry data
under this subparagraph for data required solely to
support that minor use until the final deadline for
submission of data under section 136a–1 of this title
for the other uses of the pesticide established as of
August 3, 1996, if —
(I) the data to support other uses of the pesticide
on a food are being provided;
16a
(II) the registrant, in submitting a request for
such an extension, provides a schedule, including
interim dates to measure progress, to assure that
the data production will be completed before the
expiration of the extension period;
(III) the Administrator has determined that such
extension will not significantly delay the Administrator’s schedule for issuing a reregistration eligibility determination required under section 136a-1
of this title; and
(IV) the Administrator has determined that based
on existing data, such extension would not significantly increase the risk of any unreasonable adverse effect on the environment. If the Administrator grants an extension under this clause, the Administrator shall monitor the development of the
data and shall ensure that the registrant is meeting
the schedule for the production of the data. If the
Administrator determines that the registrant is not
meeting or has not met the schedule for the production of such data, the Administrator may proceed in
accordance with clause (iv) regarding the continued
registration of the affected products with the minor
use and shall inform the public of such action. Notwithstanding the provisions of this clause, the Administrator may take action to modify or revoke the
extension under this clause if the Administrator determines that the extension for the minor use may
cause an unreasonable adverse effect on the environment. In such circumstance, the Administrator
shall provide, in writing to the registrant, a notice
revoking the extension of time for submission of data. Such data shall instead be due in accordance
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with the date established by the Administrator for
the submission of the data.
(vii) If the registrant does not commit to support a
specific minor use of the pesticide, but is supporting
and providing data in a timely and adequate fashion
to support uses of the pesticide on a food, or if all uses of the pesticide are nonfood uses and the registrant does not commit to support a specific minor use
of the pesticide but is supporting and providing data
in a timely and adequate fashion to support other
nonfood uses of the pesticide, the Administrator, at
the written request of the registrant, shall not take
any action pursuant to this clause in regard to such
unsupported minor use until the final deadline established as of August 3, 1996, for the submission of data
under section 136a–1 of this title for the supported
uses identified pursuant to this clause unless the Administrator determines that the absence of the data
is significant enough to cause human health or environmental concerns. On the basis of such determination, the Administrator may refuse the request for
extension by the registrant. Upon receipt of the request from the registrant, the Administrator shall
publish in the Federal Register a notice of the receipt
of the request and the effective date upon which the
uses not being supported will be voluntarily deleted
from the registration pursuant to section 136d(f)(1) of
this title. If the Administrator grants an extension
under this clause, the Administrator shall monitor
the development of the data for the uses being supported and shall ensure that the registrant is meeting
the schedule for the production of such data. If the
Administrator determines that the registrant is not
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meeting or has not met the schedule for the production of such data, the Administrator may proceed in
accordance with clause (iv) of this subparagraph regarding the continued registration of the affected
products with the minor and other uses and shall inform the public of such action in accordance with section 136d(f)(2) of this title. Notwithstanding the provisions of this clause, the Administrator may deny,
modify, or revoke the temporary extension under this
subparagraph if the Administrator determines that
the continuation of the minor use may cause an unreasonable adverse effect on the environment. In the
event of modification or revocation, the Administrator shall provide, in writing, to the registrant a notice
revoking the temporary extension and establish a
new effective date by which the minor use shall be
deleted from the registration.
(viii)(I) If data required to support registration of a
pesticide under subparagraph (A) is requested by a
Federal or State regulatory authority, the Administrator shall, to the extent practicable, coordinate data
requirements, test protocols, timetables, and standards of review and reduce burdens and redundancy
caused to the registrant by multiple requirements on
the registrant.
(II) The Administrator may enter into a cooperative agreement with a State to carry out subclause
(I).
(III) Not later than 1 year after August 3, 1996, the
Administrator shall develop a process to identify and
assist in alleviating future disparities between Federal and State data requirements.
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(C) Simplified procedures
Within nine months after September 30, 1978, the
Administrator shall, by regulation, prescribe simplified procedures for the registration of pesticides,
which shall include the provisions of subparagraph
(D) of this paragraph.
(D) Exemption
No applicant for registration of a pesticide who
proposes to purchase a registered pesticide from another producer in order to formulate such purchased
pesticide into the pesticide that is the subject of the
application shall be required to—
(i) submit or cite data pertaining to such purchased product; or
(ii) offer to pay reasonable compensation otherwise required by paragraph (1)(D) of this subsection for the use of any such data.
(E) Minor use waiver
In handling the registration of a pesticide for a minor use, the Administrator may waive otherwise applicable data requirements if the Administrator determines that the absence of such data will not prevent the Administrator from determining —
(i) the incremental risk presented by the minor
use of the pesticide; and
(ii) that such risk, if any, would not be an unreasonable adverse effect on the environment.
(3) Application
(A) In general
The Administrator shall review the data after receipt of the application and shall, as expeditiously as
possible, either register the pesticide in accordance
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with paragraph (5), or notify the applicant of the Administrator’s determination that it does not comply
with the provisions of the subchapter in accordance
with paragraph (6).
(B) Identical or substantially similar
(i) The Administrator shall, as expeditiously as possible, review and act on any application received by
the Administrator that —
(I) proposes the initial or amended registration of
an end-use pesticide that, if registered as proposed,
would be identical or substantially similar in composition and labeling to a currently-registered pesticide identified in the application, or that would differ in composition and labeling from such currentlyregistered pesticide only in ways that would not
significantly increase the risk of unreasonable adverse effects on the environment; or
(II) proposes an amendment to the registration of
a registered pesticide that does not require scientific review of data.
(i) In expediting the review of an application for an
action described in clause (i), the Administrator
shall—
(I) review the application in accordance with section 136w-8(f)(4)(B) of this title and, if the application is found to be incomplete, reject the application;
(II) not later than the applicable decision review
time established pursuant to section 136w–
8(f)(4)(B) of this title, or, if no review time is established, not later than 90 days after receiving a complete application, notify the registrant if the application has been granted or denied; and
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(III) if the application is denied, notify the registrant in writing of the specific reasons for the denial
of the application.
(C) Minor use registration
(i) The Administrator shall, as expeditiously as possible, review and act on any complete application—
(I) that proposes the initial registration of a new
pesticide active ingredient if the active ingredient is
proposed to be registered solely for minor uses, or
proposes a registration amendment solely for minor
uses to an existing registration; or
(II) for a registration or a registration amendment that proposes significant minor uses.
(ii) For the purposes of clause (i) —
(I) the term ‘‘as expeditiously as possible’’ means
that the Administrator shall, to the greatest extent
practicable, complete a review and evaluation of all
data, submitted with a complete application, within
12 months after the submission of the complete application, and the failure of the Administrator to
complete such a review and evaluation under clause
(i) shall not be subject to judicial review; and
(II) the term ‘‘significant minor uses’’ means 3 or
more minor uses proposed for every nonminor use,
a minor use that would, in the judgment of the Administrator, serve as a replacement for any use
which has been canceled in the 5 years preceding
the receipt of the application, or a minor use that in
the opinion of the Administrator would avoid the reissuance of an emergency exemption under section
136p of this title for that minor use.
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(D) Adequate time for submission of minor use
data
If a registrant makes a request for a minor use
waiver, regarding data required by the Administrator, pursuant to paragraph (2)(E), and if the Administrator denies in whole or in part such data waiver request, the registrant shall have a full-time period for
providing such data. For purposes of this subparagraph, the term ‘‘full-time period’’ means the time
period originally established by the Administrator for
submission of such data, beginning with the date of
receipt by the registrant of the Administrator’s notice of denial.
(4) Application
The Administrator shall publish in the Federal Register, promptly after receipt of the statement and other
data required pursuant to paragraphs (1) and (2), a notice of each application for registration of any pesticide
if it contains any new active ingredient or if it would
entail a changed use pattern. The notice shall provide
for a period of 30 days in which any Federal agency or
any other interested person may comment.
(5) Approval of registration
The Administrator shall register a pesticide if the
Administrator determines that, when considered with
any restrictions imposed under subsection (d) —
(A) its composition is such as to warrant the proposed claims for it;
(B) its labeling and other material required to be
submitted comply with the requirements of this subchapter;
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(C) it will perform its intended function without unreasonable adverse effects on the environment; and
(D) when used in accordance with widespread and
commonly recognized practice it will not generally
cause unreasonable adverse effects on the environment.
The Administrator shall not make any lack of essentiality a criterion for denying registration of any pesticide.
Where two pesticides meet the requirements of this
paragraph, one should not be registered in preference
to the other. In considering an application for the registration of a pesticide, the Administrator may waive data requirements pertaining to efficacy, in which event
the Administrator may register the pesticide without
determining that the pesticide’s composition is such as
to warrant proposed claims of efficacy. If a pesticide is
found to be efficacious by any State under section
136v(c) of this title, a presumption is established that
the Administrator shall waive data requirements pertaining to efficacy for use of the pesticide in such State.
(6) Denial of registration
If the Administrator determines that the requirements of paragraph (5) for registration are not satisfied, the Administrator shall notify the applicant for
registration of the Administrator’s determination and
of the Administrator’s reasons (including the factual
basis) therefor, and that, unless the applicant corrects
the conditions and notifies the Administrator thereof
during the 30-day period beginning with the day after
the date on which the applicant receives the notice, the
Administrator may refuse to register the pesticide.
Whenever the Administrator refuses to register a pesticide, the Administrator shall notify the applicant of
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the Administrator’s decision and of the Administrator’s
reasons (including the factual basis) therefor. The Administrator shall promptly publish in the Federal Register notice of such denial of registration and the reasons therefor. Upon such notification, the applicant for
registration or other interested person with the concurrence of the applicant shall have the same remedies
as provided for in section 136d of this title.
(7) Denial of registration
Notwithstanding the provisions of paragraph (5) —
(A) The Administrator may conditionally register
or amend the registration of a pesticide if the Administrator determines that
(i) the pesticide and proposed use are identical or
substantially similar to any currently registered pesticide and use thereof, or differ only in ways that
would not significantly increase the risk of unreasonable adverse effects on the environment, and (ii) approving the registration or amendment in the manner
proposed by the applicant would not significantly increase the risk of any unreasonable adverse effect on
the environment. An applicant seeking conditional
registration or amended registration under this subparagraph shall submit such data as would be required to obtain registration of a similar pesticide
under paragraph (5). If the applicant is unable to
submit an item of data because it has not yet been
generated, the Administrator may register or amend
the registration of the pesticide under such conditions as will require the submission of such data not
later than the time such data are required to be submitted with respect to similar pesticides already registered under this subchapter.
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(B) The Administrator may conditionally amend the
registration of a pesticide to permit additional uses of
such pesticide notwithstanding that data concerning
the pesticide may be insufficient to support an unconditional amendment, if the Administrator determines that (i) the applicant has submitted satisfactory data pertaining to the proposed additional use, and
(ii) amending the registration in the manner proposed by the applicant would not significantly in
crease the risk of any unreasonable adverse effect on
the environment. Notwithstanding the foregoing provisions of this subparagraph, no registration of a pesticide may be amended to permit an additional use of
such pesticide if the Administrator has issued a notice stating that such pesticide, or any ingredient
thereof, meets or exceeds risk criteria associated in
whole or in part with human dietary exposure enumerated in regulations issued under this subchapter,
and during the pendency of any risk-benefit evaluation initiated by such notice, if (I) the additional use
of such pesticide involves a major food or feed crop,
or (II) the additional use of such pesticide involves a
minor food or feed crop and the Administrator determines, with the concurrence of the Secretary of
Agriculture, there is available an effective alternative
pesticide that does not meet or exceed such risk criteria. An applicant seeking amended registration under this subparagraph shall submit such data as
would be required to obtain registration of a similar
pesticide under paragraph (5). If the applicant is unable to submit an item of data (other than data pertaining to the proposed additional use) because it has
not yet been generated, the Administrator may
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amend the registration under such conditions as will
require the submission of such data not later than the
time such data are required to be submitted with respect to similar pesticides already registered under
this subchapter.
(C) The Administrator may conditionally register a
pesticide containing an active ingredient not contained in any currently registered pesticide for a period reasonably sufficient for the generation and
submission of required data (which are lacking because a period reasonably sufficient for generation of
the data has not elapsed since the Administrator first
imposed the data requirement) on the condition that
by the end of such period the Administrator receives
such data and the data do not meet or exceed risk criteria enumerated in regulations issued under this
subchapter, and on such other conditions as the Administrator may prescribe. A conditional registration
under this subparagraph shall be granted only if the
Administrator determines that use of the pesticide
during such period will not cause any unreasonable
adverse effect on the environment, and that use of
the pesticide is in the public interest.
(8) Interim administrative review
Notwithstanding any other provision of this subchapter, the Administrator may not initiate a public interim
administrative review process to develop a risk-benefit
evaluation of the ingredients of a pesticide or any of its
uses prior to initiating a formal action to cancel, suspend, or deny registration of such pesticide, required
under this subchapter, unless such interim administrative process is based on a validated test or other significant evidence raising prudent concerns of unreasona-
27a
ble adverse risk to man or to the environment. Notice
of the definition of the terms ‘‘validated test’’ and ‘‘other significant evidence’’ as used herein shall be published by the Administrator in the Federal Register.
(9) Labeling
(A) Additional statements
Subject to subparagraphs (B) and (C), it shall not
be a violation of this subchapter for a registrant to
modify the labeling of an antimicrobial pesticide
product to include relevant information on product
efficacy, product composition, container composition
or design, or other characteristics that do not relate
to any pesticidal claim or pesticidal activity.
(B) Requirements
Proposed labeling information under subparagraph
(A) shall not be false or misleading, shall not conflict
with or detract from any statement required by law
or the Administrator as a condition of registration,
and shall be substantiated on the request of the Administrator.
(C) Notification and disapproval
(i) Notification
A registration may be modified under subparagraph (A) if —
(I) the registrant notifies the Administrator in
writing not later than 60 days prior to distribution
or sale of a product bearing the modified labeling;
and
(II) the Administrator does not disapprove of
the modification under clause (ii).
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(ii) Disapproval
Not later than 30 days after receipt of a notification under clause (i), the Administrator may disapprove the modification by sending the registrant
notification in writing stating that the proposed
language is not acceptable and stating the reasons
why the Administrator finds the proposed modification unacceptable.
(iii) Restriction on sale
A registrant may not sell or distribute a product
bearing a disapproved modification.
(iv) Objection
A registrant may file an objection in writing to a
disapproval under clause (ii) not later than 30 days
after receipt of notification of the disapproval.
(v) Final action
A decision by the Administrator following receipt
and consideration of an objection filed under clause
(iv) shall be considered a final agency action.
(D) Use dilution
The label or labeling required under this subchapter for an antimicrobial pesticide that is or may be diluted for use may have a different statement of caution or protective measures for use of the recommended diluted solution of the pesticide than for use
of a concentrate of the pesticide if the Administrator
determines that —
(i) adequate data have been submitted to support
the statement proposed for the diluted solution uses; and
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(ii) the label or labeling provides adequate protection for exposure to the diluted solution of the pesticide.
(10) Expedited registration of pesticides
(A) Not later than 1 year after August 3, 1996, the
Administrator shall, utilizing public comment, develop
procedures and guidelines, and expedite the review of
an application for registration of a pesticide or an
amendment to a registration that satisfies such guidelines.
(B) Any application for registration or an amendment, including biological and conventional pesticides,
will be considered for expedited review under this paragraph. An application for registration or an amendment shall qualify for expedited review if use of the
pesticide proposed by the application may reasonably
be expected to accomplish 1 or more of the following:
(i) Reduce the risks of pesticides to human health.
(ii) Reduce the risks of pesticides to nontarget organisms.
(iii) Reduce the potential for contamination of
groundwater, surface water, or other valued environmental resources.
(iv) Broaden the adoption of integrated pest management strategies, or make such strategies more
available or more effective.
(C) The Administrator, not later than 30 days after
receipt of an application for expedited review, shall notify the applicant whether the application is complete.
If it is found to be incomplete, the Administrator may
either reject the request for expedited review or ask
the applicant for additional information to satisfy the
guidelines developed under subparagraph (A).
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(11) Interagency working group
(A) Interagency working group
In this paragraph, the term ‘‘covered agency’’
means any of the following:
(i) The Department of Agriculture.
(ii) The Department of Commerce.
(iii) The Department of the Interior.
(iv) The Council on Environmental Quality.
(v) The Environmental Protection Agency.
(B) Establishment
The Administrator shall establish an interagency
working group, to be comprised of representatives
from each covered agency, to provide recommendations regarding, and to implement a strategy for improving, the consultation process required under section 7 of the Endangered Species Act of 1973 (16
U.S.C. 1536) for pesticide registration and registration review.
(C) Duties
The interagency working group established under
subparagraph (B) shall—
(i) analyze relevant Federal law (including regulations) and case law for purposes of providing an
outline of the legal and regulatory framework for
the consultation process referred to in that subparagraph, including —
(I) requirements under this subchapter and the
Endangered Species Act of 1973 (16 U.S.C. 1531
et seq.);
(II) Federal case law regarding the intersection
of this subchapter and the Endangered Species
Act of 1973 (16 U.S.C. 1531 et seq.); and
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(III) Federal regulations relating to the pesticide consultation process;
(ii) provide advice regarding methods of —
(I) defining the scope of actions of the covered
agencies that are subject to the consultation requirement referred to in subparagraph (B); and
(II) properly identifying and classifying effects
of actions of the covered agencies with respect to
that consultation requirement;
(iii) identify the obligations and limitations under
Federal law of each covered agency for purposes of
providing a legal and regulatory framework for developing the recommendations referred to in subparagraph (B);
(iv) review practices for the consultation referred
to in subparagraph (B) to identify problem areas,
areas for improvement, and best practices for conducting that consultation among the covered agencies;
(v) develop scientific and policy approaches to increase the accuracy and timeliness of the process
for that consultation, in accordance with requirements of this subchapter and the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.), including —
(I) processes to efficiently share data and coordinate analyses among the Department of Agriculture, the Department of Commerce, the Department of the Interior, and the Environmental
Protection Agency;
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(II) a streamlined process for identifying which
actions require no consultation, informal consultation, or formal consultation;
(III) an approach that will provide clarity with
respect to what constitutes the best scientific and
commercial data available in the fields of pesticide
use and ecological risk assessment, pursuant to
section 7(a)(2) of the Endangered Species Act of
1973 (16 U.S.C. 1536(a)(2)); and
(IV) approaches that enable the Environmental
Protection Agency to better assist the Department of the Interior and the Department of
Commerce in carrying out obligations under that
section in a timely and efficient manner; and
(vi) propose and implement a strategy to implement approaches to consultations under the Endangered Species Act of 1973 (16 U.S.C. 1531 et
seq.) and document that strategy in a memorandum
of understanding, revised regulations, or another
appropriate format to promote durable cooperation
among the covered agencies.
(D) Reports
(i) Progress reports
(I) In general
Not later than 18 months after December 20,
2018, the Administrator, in coordination with the
head of each other covered agency, shall submit to
the Committee on Agriculture of the House of
Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report describing the progress of the working group
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in developing the recommendations under subparagraph (B).
(II) Requirements
The report under this clause shall —
(aa) reflect the perspectives of each covered
agency; and
(bb) identify areas of new consensus and continuing topics of disagreement and debate.
(ii) Results
(I) In general
Not later than 1 year after December 20, 2018,
the Administrator, in coordination with the head
of each other covered agency, shall submit to the
Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report describing —
(aa) the recommendations developed under
subparagraph (B); and
(bb) plans for implementation of those recommendations.
(II) Requirements
The report under this clause shall —
(aa) reflect the perspectives of each covered
agency; and
(bb) identify areas of consensus and continuing topics of disagreement and debate, if any.
(iii) Implementation
Not later than 1 year after the date of submission
of the report under clause (i), the Administrator, in
coordination with the head of each other covered
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agency, shall submit to the Committee on Agriculture of the House of Representatives and the
Committee on Agriculture, Nutrition, and Forestry
of the Senate a report describing —
(I) the implementation of the recommendations
referred to in that clause;
(II) the extent to which that implementation
improved the consultation process referred to in
subparagraph (B); and
(III) any additional recommendations for improvements to the process described in subparagraph (B).
(iv) Other reports
Not later than the date that is 180 days after the
date of submission of the report under clause (iii),
and not less frequently than once every 180 days
thereafter during the 5-year period beginning on
that date, the Administrator, in coordination with
the head of each other covered agency, shall submit
to the Committee on Agriculture of the House of
Representatives and the Committee on Agriculture,
Nutrition, and Forestry of the Senate a report describing —
(I) the implementation of the recommendations
referred to in that clause;
(II) the extent to which that implementation
improved the consultation process referred to in
subparagraph (B); and
(III) any additional recommendations for improvements to the process described in subparagraph (B).
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(E) Consultation with private sector
In carrying out the duties under this paragraph,
the working group shall, as appropriate —
(i) consult with, representatives of interested industry stakeholders and nongovernmental organizations; and
(ii) take into consideration factors, such as actual
and potential differences in interest between, and
the views of, those stakeholders and organizations.
(F) Chapter 10 of title 5
Chapter 10 of title 5 shall not apply to the working
group established under this paragraph.
(G) Savings clause
Nothing in this paragraph supersedes any provision
of —
(i) this subchapter; or
(ii) the Endangered Species Act of 1973 (16
U.S.C. 1531 et seq.), including the requirements
under section 7 of that Act (16 U.S.C. 1536).
(d) Classification of pesticides
(1) Classification for general use, restricted use, or
both
(A) As a part of the registration of a pesticide the
Administrator shall classify it as being for general use
or for restricted use. If the Administrator determines
that some of the uses for which the pesticide is registered should be for general use and that other uses for
which it is registered should be for restricted use, the
Administrator shall classify it for both general use and
restricted use. Pesticide uses may be classified by regulation on the initial classification, and registered pesticides may be classified prior to reregistration. If
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some of the uses of the pesticide are classified for general use, and other uses are classified for restricted
use, the directions relating to its general uses shall be
clearly separated and distinguished from those directions relating to its restricted uses. The Administrator
may require that its packaging and labeling for restricted uses shall be clearly distinguishable from its
packaging and labeling for general uses.
(B) If the Administrator determines that the pesticide, when applied in accordance with its directions for
use, warnings and cautions and for the uses for which it
is registered, or for one or more of such uses, or in accordance with a widespread and commonly recognized
practice, will not generally cause unreasonable adverse
effects on the environment, the Administrator will
classify the pesticide, or the particular use or uses of
the pesticide to which the determination applies, for
general use.
(C) If the Administrator determines that the pesticide, when applied in accordance with its directions for
use, warnings and cautions and for the uses for which it
is registered, or for one or more of such uses, or in accordance with a widespread and commonly recognized
practice, may generally cause, without additional regulatory restrictions, unreasonable adverse effects on the
environment, including injury to the applicator, the
Administrator shall classify the pesticide, or the particular use or uses to which the determination applies,
for restricted use:
(i) If the Administrator classifies a pesticide, or one
or more uses of such pesticide, for restricted use because of a determination that the acute dermal or inhalation toxicity of the pesticide presents a hazard to
37a
the applicator or other persons, the pesticide shall be
applied for any use to which the restricted classification applies only by or under the direct supervision of
a certified applicator.
(ii) If the Administrator classifies a pesticide, or one
or more uses of such pesticide, for restricted use because of a determination that its use without additional regulatory restriction may cause unreasonable
adverse effects on the environment, the pesticide
shall be applied for any use to which the determination applies only by or under the direct supervision of
a certified applicator, or subject to such other restrictions as the Administrator may provide by regulation. Any such regulation shall be reviewable in the
appropriate court of appeals upon petition of a person
adversely affected filed within 60 days of the publication of the regulation in final form.
(2) Change in classification
If the Administrator determines that a change in the
classification of any use of a pesticide from general use
to restricted use is necessary to prevent unreasonable
adverse effects on the environment, the Administrator
shall notify the registrant of such pesticide of such determination at least forty-five days before making the
change and shall publish the proposed change in the
Federal Register. The registrant, or other interested
person with the concurrence of the registrant, may
seek relief from such determination under section
136d(b) of this title.
(3) Change in classification from restricted use to
general use
The registrant of any pesticide with one or more uses
classified for restricted use may petition the Adminis-
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trator to change any such classification from restricted
to general use. Such petition shall set out the basis for
the registrant’s position that restricted use classification is unnecessary because classification of the pesticide for general use would not cause unreasonable adverse effects on the environment. The Administrator,
within sixty days after receiving such petition, shall notify the registrant whether the petition has been granted or denied. Any denial shall contain an explanation
therefor and any such denial shall be subject to judicial
review under section 136n of this title.
(e) Products with same formulation and claims
Products which have the same formulation, are manufactured by the same person, the labeling of which contains the same claims, and the labels of which bear a designation identifying the product as the same pesticide
may be registered as a single pesticide; and additional
names and labels shall be added to the registration by
supplemental statements.
(f) Miscellaneous
(1) Effect of change of labeling or formulation
If the labeling or formulation for a pesticide is
changed, the registration shall be amended to reflect
such change if the Administrator determines that the
change will not violate any provision of this subchapter.
(2) Registration not a defense
In no event shall registration of an article be construed as a defense for the commission of any offense
under this subchapter. As long as no cancellation proceedings are in effect registration of a pesticide shall
be prima facie evidence that the pesticide, its labeling
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and packaging comply with the registration provisions
of the subchapter.
(3) Authority to consult other Federal agencies
In connection with consideration of any registration
or application for registration under this section, the
Administrator may consult with any other Federal
agency.
...
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§ 136j. Unlawful acts
(a) In general
(1) Except as provided by subsection (b), it shall be unla
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