USCA11 Case: 21-10994 Date Filed: 10/28/2022 Page: 1 of 14
[PUBLISH]
In the
United States Court of Appeals
For the Eleventh Circuit
____________________
No. 21-10994
____________________
JOHN D. CARSON,
Plaintiff-Appellant,
versus
MONSANTO COMPANY,
Defendant-Appellee.
____________________
Appeal from the United States District Court
for the Southern District of Georgia
D.C. Docket No. 4:17-cv-00237-RSB-CLR
____________________
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2 Opinion of the Court 21-10994
Before ROSENBAUM, TJOFLAT, Circuit Judges, and MOODY, District
Judge.
TJOFLAT, Circuit Judge:
We vacate and withdraw our previous opinion dated July
12, 2022,
39 F.4th 1334 (11th Cir. 2022), and substitute the follow-
ing opinion.
Federal preemption is a bitter pill. We should administer it
carefully. And, applying such care to the present case, we hold that
John Carson’s Georgia failure to warn claim is not preempted by
the federal requirements under the Federal Insecticide, Fungicide,
and Rodenticide Act (“FIFRA”) or the Environmental Protection
Agency’s (“EPA”) actions pursuant to it.
I.
John Carson regularly used Roundup® on his lawn for about
30 years until 2016. Around 2016, Carson was diagnosed with ma-
lignant fibrous histiocytoma, which he believes was linked to the
compound glyphosate, the main chemical ingredient in
Roundup®.
Carson filed suit against Monsanto, the manufacturer of
Roundup®, on December 5, 2017. In his four-count complaint, Car-
son alleged strict liability for a design defect under Georgia law
(Count I); strict liability for failure to warn under Georgia law
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21-10994 Opinion of the Court 3
(Count II); negligence under Georgia law (Count III); and breach
of implied warranties under Georgia law (Count IV).1
Monsanto filed an answer to the Complaint and subse-
quently moved for judgment on the pleadings. 2 The District Court
partially granted the motion. The District Court ruled that Car-
son’s Count II failure to warn claim was preempted under FIFRA
because the EPA had classified glyphosate as not likely to be car-
cinogenic to humans and ruled that Carson’s Count IV breach of
implied warranties claim under Georgia law was preempted for the
same reason. The District Court also dismissed Counts I and III for
the strict liability design defect and negligence to the extent that
those claims related to how Roundup® was labeled or packaged.
Carson moved to amend his complaint to dismiss Counts I and III
of the complaint pursuant to a settlement agreement with Mon-
santo but preserved his right to appeal Count II, the failure to warn
claim. The District Court granted that motion, thereby eliminating
Counts I and III from the Complaint. Carson timely appealed the
District Court’s judgment on the pleadings as to Count II.
On appeal, we are essentially tasked with deciding whether
the District Court erred in concluding that Carson’s failure to warn
1 Carson did not specify that his cause of action was under Georgia law in his
Complaint, but the District Court determined that his common law claims fell
under Georgia law, and Carson does not challenge that determination.
2 The judgment on the pleadings challenged the legal sufficiency of the Com-
plaint based on federal preemption grounds.
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4 Opinion of the Court 21-10994
claim was preempted under FIFRA because the EPA had classified
glyphosate as not likely to be carcinogenic to humans and ap-
proved the Roundup® label. We conclude it did, reverse the Dis-
trict Court’s ruling, and remand for further proceedings.
II.
“Judgment on the pleadings is proper when no issues of ma-
terial fact exist, and the movant is entitled to judgment as a matter
of law.” Ortega v. Christian,
85 F.3d 1521, 1524 (11th Cir. 1996).
We review de novo a district court’s order granting a judgment on
the pleadings, treating the facts alleged in the complaint as true,
viewing the record in the light most favorable to the nonmovant,
and evaluating any affirmative defenses raised by the moving party
(including preemption). 3 Horsley v. Feldt,
304 F.3d 1125, 1131
(11th Cir. 2002); Irving v. Mazda Motor Corp.,
136 F.3d 764, 767
(11th Cir. 1998).
III.
Starting at the beginning of the EPA’s work in a pesticide
case like this one, FIFRA requires all pesticide manufacturers to go
through a registration process with the EPA before selling a
3 In this case, any evidence submitted by Monsanto to support its defense of
federal preemption turns out not to be probative because the EPA has not
acted with the force of law such as to meet the threshold inquiry for federal
preemption, as discussed infra Part IV.
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21-10994 Opinion of the Court 5
particular pesticide. See 7 U.S.C. § 136a;
40 C.F.R. § 155.58. As part
of that process, the manufacturer submits a proposed label and rel-
evant data for registration to the EPA. 7 U.S.C. §§ 136a(c)(1)(C),
(F). In turn, the EPA reviews the efficacy of the pesticide, the ad-
verse health consequences or environmental effects of the pesti-
cide, and the labels on the pesticide for compliance with FIFRA’s
labeling requirements. Id. § 136a(c)(5).
FIFRA prohibits pesticide manufacturers from selling a pes-
ticide that is “misbranded.” Id. § 136j(a)(1)(E). Misbranding could
mean that a pesticide label contains information that is “false or
misleading in any particular.” 4 Id. § 136(q)(1)(A). A pesticide can
also be misbranded if the label does not “contain directions for use”
or “a warning or caution statement” that is “adequate to protect
health and the environment.” Id. § 136(q)(1)(F), (G).
So, the EPA checks for these possible misbranding violations
on labels when completing the registration process for pesticide
manufacturers. Id. § 136a(c)(5)(B). But, even with EPA oversight
at the initial registration process, 5 pesticide manufacturers have a
perpetual duty to adhere to FIFRA’s labeling requirements and to
4 “The term ‘label’ means the written, printed, or graphic matter on, or at-
tached to, the pesticide or device or any of its containers or wrappers.”
7
U.S.C. § 136(p)(1).
5 The EPA must reconsider a pesticide’s registration every fifteen years. 7
U.S.C. § 136a(g)(1)(A)(iv).
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6 Opinion of the Court 21-10994
report any new adverse effects to the EPA. Id. § 136j(a)(1)(E);
§ 136a(f)(1); § 136d(a)(2);
40 C.F.R. § 159.184. And, sometimes, the
EPA might just miss a misbranded label in the registration process.
FIFRA accounts for that possibility by explaining that “[i]n no event
shall registration of an article be construed as a defense for the com-
mission of any offense under this subchapter.” 7 U.S.C. § 136a(f)(2).
In other words, a pesticide manufacturer can’t point to EPA regis-
tration as a defense to a misbranding violation under FIFRA.
In sum, we have two things going on here: 1) we have the
EPA’s registration process for pesticide manufacturers seeking to
market their pesticides; and 2) we have FIFRA’s statutory labeling
requirements and consequences for failing to properly label. These
two components underlie the preemption analysis.
IV.
Sometimes, FIFRA or the EPA’s actions pursuant to FIFRA
may preempt state law. But only federal action with the force of
law has the capacity to preempt state law. 6 See Wyeth v. Levine,
6 Congress created wide latitude for state regulation in the context of FIFRA.
See 7 U.S.C. § 136v(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.”); see
also Bates v. Dow Agrosciences LLC,
544 U.S. 431, 446,
125 S. Ct. 1788, 1799
(2005) (“Under § 136v(a), a state agency may ban the sale of a pesticide if it
finds, for instance, that one of the pesticide's label-approved uses is unsafe.
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21-10994 Opinion of the Court 7
555 U.S. 555, 576, 580,
129 S. Ct. 1187, 1200 (2009). So, any preemp-
tion analysis of agency action in the FIFRA context beyond the stat-
ute itself first requires us to do a Mead analysis. 7 United States v.
Mead Corp.,
533 U.S. 218, 230–31,
121 S. Ct. 2164, 2172–73 (2001).
If, and only if, the EPA has acted with the force of law, may we
move on to a preemption analysis.
In the universe where there is either an applicable FIFRA
statute or the EPA has acted with the force of law, we turn to
FIFRA’s uniformity statute, which says that no state shall “impose
or continue in effect any requirements for labeling or packaging in
addition to or different from those required under this subchapter.”
7 U.S.C. § 136v(b). So, a state rule, including a common-law cause
of action like Georgia’s failure-to-warn claim, is preempted by
FIFRA if two conditions are met: 1) the state requirement must be
This ban might well induce the manufacturer to change its label to warn
against this questioned use.”).
7 The Supremacy Clause, the source of federal preemption, only applies to
agency action that constitutes “federal law.” Marrache v. Bacardi U.S.A., Inc.,
17 F.4th 1084, 1094 (11th Cir. 2021); cf. Reid v. Johnson & Johnson,
780 F.3d
952, 964 (9th Cir. 2015) (“In both Chevron and preemption contexts, a central
inquiry is whether an agency has validly created federal law pursuant to the
gap-filling power delegated to it by Congress. In the former situation, we de-
cide whether Chevron-level deference is due because Congress intended for
the agency’s pronouncement to carry the force of law; in the latter, we decide
whether state law is preempted because Congress intended for the agency’s
pronouncement to carry the binding and exclusive force of federal law. Crea-
tion of federal law should demand at least the same formality for purposes of
preemption as it does for purposes of Chevron deference.”).
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8 Opinion of the Court 21-10994
“for labeling or packaging” under the language of the statute; and
2) the state requirement is “in addition to or different from” re-
quirements derived from FIFRA. Id.; see also Bates,
544 U.S. at 444,
125 S. Ct. at 1798. Straightforward in recitation. A bit complicated
in practice.
Since Carson’s failure to warn claim under Georgia law
hinges on whether Georgia’s cause of action is different from or in
addition to the federal law imposed on Monsanto for its marketing
of Roundup®, we must first look to FIFRA’s misbranding statutes
and then to the EPA’s registration process.
We begin with the FIFRA labeling provisions, which obvi-
ously carry the force of law, to determine whether Georgia’s failure
to warn claims are different from or in addition to those federal
statutes. 8 FIFRA requires that pesticide labels “contain a warning
or caution statement which may be necessary and if complied with
. . . is adequate to protect health and the environment."
7 U.S.C.
§ 136(q)(1)(G). Georgia law subjects a manufacturer to liability for
failure to warn when the manufacturer “(a) knows or has reason to
know that the chattel is or is likely to be dangerous for the use for
which it is supplied, and (b) has no reason to believe that those for
8 We note that the first step of the Bates test is met as to the FIFRA statutes.
Georgia’s common law cause of action for failure to warn is clearly an impo-
sition of a labeling or packaging requirement. See Greenway v. Peabody Int'l
Corp.,
294 S.E.2d 541, 545–46 (Ga. 1982) (quoting Restatement (Second) of
Torts § 388). We need not analyze this step any further.
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21-10994 Opinion of the Court 9
whose use the chattel is supplied will realize its dangerous condi-
tion and (c) fails to exercise reasonable care to inform them of its
dangerous condition or of the facts which make it likely to be dan-
gerous.” Greenway, 294 S.E.2d at 545–46 (quoting Restatement
(Second) of Torts § 388). Matching up FIFRA’s labeling require-
ment with the Georgia cause of action for failure to warn, we see
that the Georgia law failure to warn claim, if anything, imposes less
of a duty on Monsanto than the FIFRA statute does because under
Georgia law Monsanto is only required to warn when those who
will be using the product do not realize the dangerous condition of
the product. On the other hand, FIFRA imposes a blanket duty,
regardless of the knowledge of the consumer, when the warning is
necessary to protect health and the environment. In practice, the
Georgia failure to warn claim simply enforces the FIFRA cause of
action, so it is not expressly preempted. Bates,
544 U.S. at 447–48,
125 S. Ct. at 1800.
Because FIFRA alone does not preempt the Georgia failure
to warn cause of action, we turn to the EPA’s registration process.
The EPA registered Roundup®, whose main chemical ingredient is
glyphosate, for distribution, sale, and manufacture in the United
States. Even with that approval, Carson argues that Roundup’s®
label failed to adequately warn of the harmful nature of glyphosate
under Georgia law. So, the question under FIFRA is whether Geor-
gia common law failure to warn would be different from or in ad-
dition to any action the EPA has taken that has the force of law. 7
U.S.C. § 136v(b). Connecting the dots, the only way that we could
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10 Opinion of the Court 21-10994
have a preemption problem in the registration process is if the EPA
registration process itself carries with it the force of law. Other-
wise, the threshold step for preemption—the force of law—is not
met, and we can’t even continue to the Bates analysis for preemp-
tion of state law under FIFRA.
The problem for Monsanto is that the EPA’s registration
process is not sufficiently formal to carry with it the force of law
under Mead. See Mead Corp.,
533 U.S. at 230,
121 S. Ct. at 2172
(“It is fair to assume generally that Congress contemplates admin-
istrative action with the effect of law when it provides for a rela-
tively formal administrative procedure tending to foster the fair-
ness and deliberation that should underlie a pronouncement of
such force.”);
id. at 234,
121 S. Ct. at 2175 (“[P]olicy statements,
agency manuals, and enforcement guidelines” are insufficient to
carry the force of law.). Congress itself undermined the formality
of EPA registration when it explained that EPA registration served
only as prima facie evidence of compliance with the registration
requirements of FIFRA. 9 7 U.S.C. § 136a(f)(2). In short, we can
only take EPA registration for what it’s worth. And it doesn’t
amount to a sufficiently formal proceeding to carry the force of law
since it at most creates a rebuttable presumption of compliance
9 We note that compliance with the registration process does not even serve
as evidence of compliance with the labeling provisions of FIFRA. See 7 U.S.C.
§ 136a(f)(2) (“In no event shall registration of an article be construed as a de-
fense for the commission of any offense under this subchapter.”).
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21-10994 Opinion of the Court 11
with FIFRA’s registration process and nothing more. 10 See Harde-
man v. Monsanto Co.,
997 F.3d 941, 956 (9th Cir. 2021) (“So even
though EPA approved Roundup’s® label, a judge or jury could dis-
agree and find that same label violates FIFRA.”). 11
In its final effort to have Georgia law preempted, Monsanto
points to various EPA documents to suggest that the EPA has acted
with the force of law, such that Monsanto could not label
Roundup® as carcinogenic without consequences from the EPA.
In its brief, Monsanto points to the following actions as having the
force of law:
10 And, even if this were a close case on whether the EPA has acted with the
force of law, which it isn’t, “[t]he long history of tort litigation against manu-
facturers of poisonous substances adds force to the [existing] presumption
against pre-emption, for Congress surely would have expressed its intention
more clearly if it had meant to deprive injured parties of a long available form
of compensation.” Bates,
544 U.S. at 432–33,
125 S. Ct. at 1792.
11 Monsanto also makes a separate argument that Georgia’s failure to warn
claim is impliedly preempted because Monsanto cannot comply with both
state and federal requirements. See Mutual Pharmaceutical Co., Inc. v. Bart-
lett,
570 U.S. 472, 480,
133 S. Ct. 2466, 2473 (2013). Because an implied
preemption analysis turns on whether a federal agency has indicated through
some action carrying the force of law that it would not accept a label mandated
by state law, Merck Sharp & Dohme Corp. v. Albrecht,
139 S. Ct. 1668, 1678–
79 (2019), and we have already determined that the EPA has not acted with
the force of law and that FIFRA statutes are consistent with Georgia law, we
do not address this argument further.
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12 Opinion of the Court 21-10994
• The EPA’s Label Registration, and subsequent in-
terim registration reviews and re-registration eligibil-
ity decisions of glyphosate pesticides. EPA, Reregis-
tration Eligibility Decision (RED) – Glyphosate (Sept.
1993); EPA, Glyphosate: Interim Registration Review
Decision Case No. 0178 (Jan. 2020) (1993 reregistra-
tion); The EPA’s response to comments on the
glyphosate proposed interim decision. EPA, Re-
sponse from the Pesticide Re-evaluation Division
(PRD) to Comments on the Glyphosate Proposed In-
terim Decision (Jan. 2020).
• An EPA Paper written about the EPA Scientific Advi-
sory Panel’s independent review of the effects of
glyphosate. EPA, Revised Glyphosate Issue Paper
(Dec. 12, 2017).
• A letter issued by the EPA in August 2019. EPA, Of-
fice of Pesticide Programs, Letter to Glyphosate Reg-
istrants Regarding Labeling Requirements (Aug. 7,
2019) (“Letter to Registrants”).
• Various papers involving scientific analysis where the
EPA concluded that glyphosate does not cause can-
cer. EPA, Health Effects Division, Second Peer Re-
view of Glyphosate (Oct. 30, 1991); EPA, Report of
the Hazard Identification Assessment Review
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21-10994 Opinion of the Court 13
Committee at 6-7 (Apr. 20, 1998), https://ti-
nyurl.com/b95mdvja; Final Rule: Glyphosate; Pesti-
cide Tolerances,
67 Fed. Reg. 60,934, 60,935-43 (Sept.
27, 2002); Final Rule: Glyphosate, Pesticide Toler-
ances,
73 Fed. Reg. 73,586, 73,589 (Dec. 3, 2008); EPA,
Office of Pesticide Programs, Glyphosate Issue Paper:
Evaluation of Carcinogenic Potential at 141 (Sept. 12,
2016), https://tinyurl.com/4d6us439; EPA, Office of
Pesticide Programs, Revised Glyphosate Issue Paper:
Evaluation of Carcinogenic Potential (Dec. 12, 2017);
EPA, Glyphosate – Proposed Interim Registration Re-
view Decision Case Number 0178 (Apr. 2019).
The problem for Monsanto is again that none of these doc-
uments have the indicia of formality to pass the Mead standard.
Monsanto cannot wave the “formality” wand on EPA actions to
accomplish compliance with the Mead standard. None of them are
the product of “notice-and-comment rulemaking” 12 or “formal ad-
judication.” Mead,
533 U.S. at 230. Nor do the EPA letters Mon-
santo points to “bespeak the legislative type of activity that would
12 As Monsanto correctly notes, there is something akin to a notice and com-
ment requirement in the registration process.
40 C.F.R. § 155.58. But, because
the registration itself does not lead to any formal agency action, like a rule
produced from notice-and-comment rulemaking, the fact that the EPA takes
comments on its registration decision does not change our analysis.
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14 Opinion of the Court 21-10994
naturally bind” Monsanto. Id. at 232. So, we find Monsanto’s ar-
guments on this front unpersuasive.
V.
For the foregoing reasons, we reverse the District Court’s
ruling on Carson’s failure to warn claim and remand for further
proceedings.
REVERSED AND REMANDED.
