Court Opinion

ID: 9929945
Source: CourtListenerOpinion
Date Created: 2024-02-05 20:00:56.436827+00
Date Added: 2024-06-11T10:58:07.249392
License: Public Domain

USCA11 Case: 21-10994    Document: 178-1     Date Filed: 02/05/2024   Page: 1 of 31

                                                             [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
                           ____________________
USCA11 Case: 21-10994       Document: 178-1       Date Filed: 02/05/2024       Page: 2 of 31

        2                        Opinion of the Court                    21-10994

        Before ROSENBAUM, TJOFLAT, Circuit Judges, and MOODY,∗ District
        Judge.
        ROSENBAUM, Circuit Judge:
               State tort litigation plays an important role in protecting
        consumers from dangerous products. But the federal government,
        through legislation and regulation, exercises its own authority over
        those products. And when the two conflict, federal law is supreme.
        This case requires us to decide whether the Federal Insecticide,
        Fungicide, and Rodenticide Act (“FIFRA”) preempts a state failure-
        to-warn tort claim.
                Plaintiff-Appellant John D. Carson, Sr., used the popular
        weedkiller Roundup for decades before he developed cancer. Car-
        son alleges that Roundup caused his cancer and sued Monsanto
        (Roundup’s manufacturer) for failure to warn of the product’s can-
        cerous effects, among other claims. Monsanto moved for judg-
        ment on the pleadings based on FIFRA’s preemption provision, 7
        U.S.C. § 136v(b). Specifically, Monsanto argued that FIFRA
        preempted Carson’s state-law claims because the Environmental
        Protection Agency (“Agency”) approved Roundup’s label without
        a cancer warning and classified Roundup’s main ingredient as “not
        likely to be carcinogenic.”
              The district court agreed and found that FIFRA preempted
        Carson’s claims regarding Roundup’s packaging or labeling. We

        ∗ The Honorable James S. Moody Jr., U.S. District Judge for the Middle Dis-
        trict of Florida, sitting by designation.
USCA11 Case: 21-10994     Document: 178-1        Date Filed: 02/05/2024   Page: 3 of 31

        21-10994               Opinion of the Court                         3

        reversed the district court’s dismissal of Carson’s failure-to-warn
        claim. But sitting en banc, this Court vacated the opinion and clar-
        ified the relevant express-preemption inquiry. Now, on remand,
        we reconsider whether Carson’s failure-to-warn claim is
        preempted, either expressly or impliedly.
               We conclude that FIFRA does not expressly preempt Car-
        son’s failure-to-warn claim. FIFRA’s preemption provision applies
        to only those state requirements that are “in addition to or different
        from” federal requirements. And Georgia common law does not
        impose duties “in addition to or different from” FIFRA’s require-
        ments; rather, Georgia common law is less demanding than the
        federal requirements.
                We also conclude that implied preemption does not bar Car-
        son’s failure-to-warn claim. Monsanto has not met its burden to
        show that, in an action that carried the force of law, the Agency
        would not have approved the warning label that Carson proposes.
        So Monsanto has not established that it could not have complied
        with both state and FIFRA requirements. And as a result, Mon-
        santo has failed to show that FIFRA impliedly preempts Carson’s
        state-law claim.
                                I.   BACKGROUND
                                      A. FIFRA

               The Federal Insecticide, Fungicide, and Rodenticide Act
        (“FIFRA”) regulates the use, sale, and labeling of pesticides. 7
        U.S.C. § 136 et seq. FIFRA requires all pesticide manufacturers to
USCA11 Case: 21-10994      Document: 178-1       Date Filed: 02/05/2024      Page: 4 of 31

        4                       Opinion of the Court                   21-10994

        register their pesticides with the Environmental Protection Agency
        (“Agency”) before they can be sold. See 7 U.S.C. § 136a(a). A man-
        ufacturer seeking to register a pesticide must submit a proposed
        label, as well as certain supporting data, to the Agency. 7 U.S.C.
        §§ 136a(c)(1)(C), (F). The Agency will register the pesticide if it de-
        termines that the pesticide is eﬃcacious, § 136a(c)(5)(A); that the
        pesticide will not cause unreasonable adverse eﬀects on humans
        and the environment, §§ 136a(c)(5)(C), (D); and that the pesticide’s
        label complies with the statute’s prohibition on misbranding,
        § 136a(c)(5)(B).
               FIFRA also prohibits pesticide manufacturers from selling a
        pesticide that is “misbranded.” 7 U.S.C. § 136j(a)(1)(E). A pesticide
        is “misbranded” if its label contains a statement that is “false or
        misleading in any particular” or omits adequate instructions for
        use, necessary warnings, or cautionary statements.                 Id.
        §§ 136(q)(1)(A), (F), (G).
               During the registration process, the Agency will consider
        whether a pesticide’s label is misbranded. The Agency’s initial re-
        view does not absolve the registrant’s liability if the pesticide is mis-
        branded. Pesticide manufacturers have a continuing obligation to
        adhere to FIFRA’s labeling requirements and must report any ad-
        verse eﬀects of the pesticide to the Agency. See id. §§ 136a(f )(1);
        136d(a)(2).
               Similarly, the registration process does not establish a safe
        harbor for pesticide manufacturers. FIFRA declares that, “[i]n no
        event shall registration of an article be construed as a defense for
USCA11 Case: 21-10994       Document: 178-1        Date Filed: 02/05/2024       Page: 5 of 31

        21-10994                 Opinion of the Court                             5

        the commission of any oﬀense under [FIFRA].” Id. § 136a(f )(2).
        Rather, registration serves merely as “prima facie evidence that the
        pesticide, its labeling and packaging comply with the registration
        provisions.” Id.
                FIFRA also addresses a state’s role in pesticide regulation. In
        this respect, FIFRA provides that “[a] State may regulate the sale or
        use of any federally registered pesticide or device in the State, but
        only if and to the extent the regulation does not permit any sale or
        use prohibited by this subchapter.” Id. § 136v(a). In line with this
        qualiﬁcation, a preemption provision immediately follows: states
        may “not impose or continue in eﬀect any requirements for label-
        ing or packaging in addition to or diﬀerent from those required
        under this subchapter.” Id. § 136v(b).
                                 B. Factual Background

              Plaintiﬀ-Appellant John D. Carson, Sr., used Roundup on his
        lawn for over thirty years. But when he was diagnosed with malig-
        nant ﬁbrous histiocytoma, a form of cancer, he stopped using the
        product.
                 Carson ﬁled suit against Monsanto, Roundup’s manufac-
        turer, alleging that Roundup contained a dangerous carcinogen,
        glyphosate, and that Monsanto was aware of Roundup’s harmful
        eﬀects but failed to warn customers of the dangers. In his com-
        plaint, Carson alleged four causes of action under Georgia law:
        strict liability for a design defect (Count I); strict liability for failure
        to warn (Count II); negligence (Count III); and breach of implied
        warranties (Count IV).
USCA11 Case: 21-10994     Document: 178-1     Date Filed: 02/05/2024    Page: 6 of 31

        6                     Opinion of the Court                 21-10994

                               C. Procedural History

               Monsanto moved for judgment on the pleadings on the
        ground that FIFRA’s preemption provision, 7 U.S.C. § 136v(b), ex-
        pressly preempted Carson’s suit. In the alternative, Monsanto
        claimed that the Agency’s previous approval of Roundup’s labeling
        and continued adherence to the reasoning for that decision im-
        pliedly preempted Carson’s suit. Monsanto argued that because
        the Agency declined to require a cancer warning when it registered
        and continued to approve Roundup for sale, requiring a label with
        such a warning would be “in addition to or diﬀerent from” FIFRA’s
        requirements, in violation of 7 U.S.C. § 136v(b).
               The district court granted Monsanto’s motion in part. Spe-
        ciﬁcally, the court ruled that FIFRA expressly preempted Carson’s
        failure-to-warn and breach-of-implied-warranty claims. Carson v.
        Monsanto Co., 508 F. Supp. 3d 1369, 1376–77 (S.D. Ga. 2020) (“Carson
        I”). So the district court dismissed Counts II and IV of Carson’s
        complaint. Id. at 1377–78. The court also dismissed Counts I (de-
        sign defect) and III (negligence) as preempted to the extent that
        those claims related to Roundup’s labeling or packaging. Id. at
        1378.
                Because it ruled on express-preemption grounds, the district
        court did not address Monsanto’s alternative claim that Counts II
        and IV were impliedly preempted. See id. But it did address and
        reject implied preemption with respect to Counts I and III. Id. at
        1378–79. The court reasoned that, because FIFRA gives states the
        authority to regulate pesticides, it would not be impossible for
USCA11 Case: 21-10994     Document: 178-1      Date Filed: 02/05/2024    Page: 7 of 31

        21-10994               Opinion of the Court                        7

        Monsanto to comply with both state-law and FIFRA requirements
        for manufacturing and design. See id. at 1379.
               The parties subsequently settled. In accordance with that
        “high-low” settlement agreement, Carson moved to amend his
        complaint to dismiss Counts I and III but preserved his right to ap-
        peal Count II, the failure-to-warn claim. The district court granted
        that motion, eliminating Counts I and III from Carson’s complaint.
        Carson timely appealed the district court’s grant of judgment on
        the pleadings as to Count II.
                On appeal, this panel determined that FIFRA did not
        preempt Carson’s failure-to-warn claim. Carson v. Monsanto Co., 51
        F.4th 1358, 1363 (11th Cir. 2022), reh’g en banc granted, opinion va-
        cated, No. 21-10994, 2022 WL 17813843 (11th Cir. Dec. 19, 2022)
        (“Carson II”). We concluded that Georgia’s common-law standard
        for product-safety warnings “imposes less of a duty” than FIFRA’s
        prohibition against marketing “misbranded” pesticides. Id. And
        we held that the Agency’s approval of Roundup’s labels without a
        cancer warning did not preempt the Georgia cause of action be-
        cause “only federal action with the force of law has the capacity to
        preempt state law.” Id. at 1362–65. We analyzed whether the
        Agency’s registration process carried the force of law allowing it to
        preempt Carson’s state-law claim and determined that it did not.
        Id. at 1364.
               Before the mandate issued, though, the en banc Court va-
        cated the opinion and granted rehearing on the role of a “force-of-
        law” analysis in the context of express preemption. Carson v.
USCA11 Case: 21-10994     Document: 178-1      Date Filed: 02/05/2024     Page: 8 of 31

        8                      Opinion of the Court                 21-10994

        Monsanto Co., No. 21-10994, 2022 WL 17813843 (11th Cir. Dec. 19,
        2022). Sitting en banc, the Court held that a “force-of-law” inquiry
        is “usually irrelevant where Congress has enacted an express
        preemption provision.” Carson v. Monsanto Co., 72 F.4th 1261, 1267
        (11th Cir. 2023) (en banc) (“Carson III”). Rather, an express-preemp-
        tion analysis applies the text of the preemption provision in line
        with “ordinary principles of statutory interpretation.” Id.
               The en banc Court remanded to this panel to address
        whether Carson’s failure-to-warn claim was preempted, whether
        expressly or impliedly. Id. at 1268. The Court also left for our con-
        sideration “Carson’s argument that section 136v(b)’s reference to
        ‘requirements’ compels a force-of-law inquiry as a matter of statu-
        tory interpretation.” Id. We now address those issues.

                          II. STANDARD OF REVIEW
                We review de novo a district court’s order granting judg-
        ment on the pleadings, treating the facts alleged in the complaint
        as true and viewing the record in the light most favorable to the
        nonmovant. Horsley v. Feldt, 304 F.3d 1125, 1131 (11th Cir. 2002).
        We review de novo the aﬃrmative defense of preemption. Irving v.
        Mazda Motor Corp., 136 F.3d 764, 767 (11th Cir. 1998). Judgment on
        the pleadings is proper when no issues of material fact exist and the
        moving party is entitled to judgment as a matter of law. Ortega v.
        Christian, 85 F.3d 1521, 1524 (11th Cir. 1996) (citing Fed. R. Civ. P.
        12(c)).
USCA11 Case: 21-10994      Document: 178-1       Date Filed: 02/05/2024        Page: 9 of 31

        21-10994                Opinion of the Court                            9

                                III. DISCUSSION
                Our analysis proceeds in two parts. In Part A, we consider
        Monsanto’s express-preemption defense and conclude that FIFRA
        does not expressly preempt Carson’s failure-to-warn claim. Then,
        in Part B, we address Monsanto’s implied-preemption defense and
        conclude that Monsanto has not met its burden to show impossi-
        bility preemption.
            A.     FIFRA does not expressly preempt Carson’s failure-to-warn
                                          claim.

                The Supremacy Clause of the Constitution provides that the
        laws of the United States “shall be the supreme Law of the Land.”
        U.S. Const. art. VI, cl. 2. Consistent with that command, the Su-
        preme Court has long recognized that state laws that conﬂict with
        federal law are “without eﬀect.” Altria Grp., Inc. v. Good, 555 U.S.
        70, 76 (2008) (quoting Maryland v. Louisiana, 451 U.S. 725, 746
        (1981)). Express preemption occurs when, explicitly in statutory
        text, Congress manifests its intent to preempt state law. See Med-
        tronic, Inc. v. Lohr, 518 U.S. 470, 485–86 (1996). To be sure, “we have
        long presumed that Congress does not cavalierly preempt state-law
        causes of action.” Id. at 485. But when a statute’s terms clearly
        reﬂect Congress’s intent to preempt, that statute bars any state-law
        claims that fall within its purview.
               Indeed, sitting en banc, we have clariﬁed that “[e]xpress
        preemption turns primarily on ‘the language of the preemption
        statute and the statutory framework surrounding it.’” Carson III,
        72 F.4th at 1267 (quoting Lohr, 518 U.S. at 486). So when we
USCA11 Case: 21-10994     Document: 178-1      Date Filed: 02/05/2024     Page: 10 of 31

         10                     Opinion of the Court                21-10994

         consider “an express-preemption provision, we identify the state
         law that it preempts according to ordinary principles of statutory
         interpretation, and no presumption against preemption applies.”
         Id. That is our starting point here.
                 As we’ve mentioned, FIFRA includes an express-preemption
         provision. That provision provides that a “State shall not impose
         or continue in eﬀect any requirements for labeling or packaging in
         addition to or diﬀerent from those required under” FIFRA. 7
         U.S.C. § 136v(b). We must determine the scope of that provision’s
         state-law displacement.
                The Supreme Court has explained that FIFRA is not “a suf-
         ﬁciently comprehensive statute to justify an inference that Con-
         gress had occupied the ﬁeld to the exclusion of the States.” Bates v.
         Dow Agrosciences LLC, 544 U.S. 431, 441–42 (2005) (quoting Wis. Pub.
         Intervenor v. Mortier, 501 U.S. 597, 607 (1991)). “To the contrary,
         [FIFRA] leaves ample room for States and localities to supplement
         federal eﬀorts.” Mortier, 501 U.S. at 613. For instance, “[n]othing
         in the text of FIFRA would prevent a State from making the viola-
         tion of a federal labeling or packaging requirement a state oﬀense,
         thereby imposing its own sanctions on pesticide manufacturers
         who violate federal law.” Bates, 544 U.S. at 442. So at a minimum,
         state requirements “that merely duplicate” FIFRA’s requirements
         do not violate FIFRA’s preemption provision. See id.
                To determine whether FIFRA preempts state requirements
         that go beyond “mere[] duplication” of FIFRA’s requirements, we
         turn to Bates. There, the Supreme Court clariﬁed the reach of
USCA11 Case: 21-10994      Document: 178-1       Date Filed: 02/05/2024        Page: 11 of 31

         21-10994               Opinion of the Court                            11

         FIFRA’s preemption provision. FIFRA preempts a state require-
         ment if it (1) is a “requirement ‘for labeling or packaging’”; and (2)
         that requirement “is ‘in addition to or diﬀerent from those required
         under’” FIFRA. Id. at 444 (quoting 7 U.S.C. § 136v(b)). In other
         words, FIFRA preempts any state-law labeling or packaging re-
         quirement that is not “fully consistent” with FIFRA’s requirements.
         Id. at 447. But FIFRA does not preempt state-law requirements that
         do not relate to labeling or packaging—for example, those that con-
         cern only product design or manufacture. See id. at 444.
                We now apply Bates’s two-step framework to Carson’s fail-
         ure-to-warn claim.
              1. FIFRA establishes at least three requirements for labeling.

                 We begin by identifying FIFRA’s labeling requirements for
         pesticide manufacturers. A “requirement is a rule of law that must
         be obeyed; an event . . . that merely motivates an optional decision
         is not a requirement.” Bates, 544 U.S. at 445. Starting with the stat-
         utory text, FIFRA prescribes at least three relevant requirements.
                 First, FIFRA prohibits misbranding, including on a pesti-
         cide’s label. See 7 U.S.C. § 136j(a)(1)(E). A pesticide may be mis-
         branded if its label contains a “false or misleading statement,”
         “does not contain adequate directions for use,” or “omits necessary
         warnings or caution statements.” Bates, 544 U.S. at 438. If the
         Agency determines that a pesticide is misbranded, it may institute
         cancellation proceedings, see 7 U.S.C. § 136d(b), or impose other
         civil or criminal penalties, id. § 136l.
USCA11 Case: 21-10994      Document: 178-1      Date Filed: 02/05/2024     Page: 12 of 31

         12                     Opinion of the Court                 21-10994

                 Second, FIFRA mandates pesticide registration with the
         Agency. Id. § 136a(a). To register, the manufacturer must submit
         a proposed label to the Agency along with certain supporting data.
         Id. §§ 136a(c)(1)(C), (F). Once the Agency approves a label during
         the registration process, manufacturers cannot change the label’s
         contents without the Agency’s prior approval and a new registra-
         tion application, except for “minor modiﬁcations.” 40 C.F.R.
         §§ 152.44, 152.46. The Agency reviews a pesticide’s registration,
         including its eﬀects on human health, every 15 years. Id.
         § 136a(g)(1)(A). Manufacturers must also re-register certain pesti-
         cides after a certain amount of time has passed. Id. § 136a-1(a). Re-
         registration involves ﬁve “phases,” including data gathering and
         analysis and the Agency’s independent veriﬁcation of that data’s
         adequacy. Id. § 136a-1(b).
                Third, FIFRA imposes an ongoing reporting requirement.
         Under that requirement, manufacturers must report to the Agency
         (1) “additional factual information regarding unreasonable adverse
         eﬀects on the environment,” 7 U.S.C. § 136d(a)(2), and (2) incidents
         involving a pesticide’s toxic eﬀects on humans that may not be ad-
         equately reﬂected in its label’s warnings, see 40 C.F.R. § 159.184(a).
         This reporting alerts the Agency to any developments that may ren-
         der a previously approved label misbranded.
                To sum up, FIFRA’s labeling “requirements” that bear on our
         preemption analysis are its (1) prohibition on misbranding, (2) re-
         quired registration of pesticides and their labels, and (3) ongoing
         reporting requirements.
USCA11 Case: 21-10994      Document: 178-1       Date Filed: 02/05/2024      Page: 13 of 31

         21-10994                Opinion of the Court                         13

          2. Georgia state law does not impose duties in addition to or diﬀerent
                                from FIFRA’s requirements.

                Next, we consider the state-law requirements that Carson’s
         failure-to-warn suit, if successful, would impose. Under Georgia
         law, “the duty to warn arises whenever the manufacturer knows or
         reasonably should know of the danger arising from the use of its
         product.” Chrysler Corp. v. Batten, 450 S.E.2d 208, 211 (Ga. 1994).
         That includes the duty to warn of “nonobvious foreseeable dangers
         from the normal use of its product.” Thornton v. E.I. Du Pont De
         Nemours & Co., Inc., 22 F.3d 284, 289 (11th Cir. 1994). A manufac-
         turer breaches that duty to warn “if it fails to ‘[(1)] adequately com-
         municate the warning to the ultimate user or (2) fail[s] to provide
         an adequate warning of the product’s potential risks.’” Watkins v.
         Ford Motor Co., 190 F.3d 1213, 1219 (11th Cir. 1999) (quoting
         Thornton, 22 F.3d at 289). At bottom, breach occurs when the warn-
         ing does not advise “the user of the dangers associated with the use
         of the product.” Id.
                Carson claims that Monsanto breached its state-law duty to
         warn. He alleges that Roundup’s warning “failed to contain rele-
         vant warnings, hazards, and precautions,” and instead, Monsanto
         “disseminated information that was inaccurate, false and mislead-
         ing and which failed to communicate accurately . . . [the] extent of
         the risk of injuries with use and/or exposure to Roundup.” In Car-
         son’s view, Monsanto should have included a warning about
         glyphosate’s potentially carcinogenic eﬀects on its label.
USCA11 Case: 21-10994     Document: 178-1      Date Filed: 02/05/2024     Page: 14 of 31

         14                     Opinion of the Court                21-10994

                 On their face, Carson’s claims concern labeling and packag-
         ing. And in Bates, the Supreme Court held that a common-law duty
         constitutes a state-law “requirement” within the scope of FIFRA’s
         preemption provision in section 136v(b). 544 U.S. at 446. Indeed,
         “[t]he parties agree that Carson’s suit relies on a Georgia ‘require-
         ment[] for labeling or packaging.’” Carson III, 72 F.4th at 1267
         (quoting Bates, 544 U.S. at 443). So we must determine whether
         Carson’s failure-to-warn claim would impose any duties “in addi-
         tion to or diﬀerent from” FIFRA’s requirements. See Bates, 544 U.S.
         at 447.
                  As we’ve noted, FIFRA does not preempt state-law duties,
         including common-law claims, that “parallel” or “are fully con-
         sistent with” federal requirements. Bates, 544 U.S. at 447. So while
         FIFRA may preempt additional state “requirements,” it does not
         preempt additional state “remedies” for violations of federal law.
         Id.; cf. Lohr, 518 U.S. at 513 (O’Connor, J., concurring in part and
         dissenting in part). Rather, FIFRA “authorizes a relatively decen-
         tralized scheme that preserves a broad role for state regulation.”
         Bates, 544 U.S. at 450. As long as Carson’s state-law claim “paral-
         lel[s]” FIFRA’s requirements, section 136v(b) does not expressly
         preempt that claim. See id. at 447.
                With that in mind, we revisit FIFRA’s “requirements.” Un-
         der FIFRA, a pesticide is misbranded if, for example, its “label does
         not contain a warning or caution statement which may be neces-
         sary and if complied with . . . is adequate to protect health and the
         environment.” 7 U.S.C. § 136(q)(1)(G). FIFRA’s prohibition on
USCA11 Case: 21-10994      Document: 178-1      Date Filed: 02/05/2024     Page: 15 of 31

         21-10994               Opinion of the Court                        15

         misbranding eﬀectively imposes a strict-liability standard, as it con-
         tains no element of knowledge or intent. So long as the pesticide’s
         label omits a “necessary” warning “to protect health and the envi-
         ronment,” the manufacturer is liable under FIFRA. See id.
                By comparison, under Georgia common law, a pesticide
         manufacturer breaches its duty to warn if it “fail[s] to provide an
         adequate warning of the product’s potential risks.” Watkins, 190
         F.3d at 1219 (quoting Thornton, 22 F.3d at 289). But this is not a
         limitless standard—the manufacturer is liable only if it “knows or
         reasonably should know of the danger arising from the use of its
         product.” Chrysler Corp., 450 S.E.2d at 211. And that duty extends
         to only “nonobvious foreseeable dangers from the normal use of
         its products.” CertainTeed Corp. v. Fletcher, 794 S.E.2d 641, 645 (Ga.
         2016) (quoting Thornton, 22 F.3d at 289).
                True, Georgia common law does not exactly track FIFRA’s
         requirements. But the Supreme Court has explained that “state law
         need not explicitly incorporate FIFRA’s standards as an element of
         a cause of action in order to survive pre-emption.” Bates, 544 U.S.
         at 447. Rather, so long as the state-law duty parallels or is “fully
         consistent” with FIFRA, FIFRA does not preempt it. Id. And here,
         the practical eﬀect is the same: both FIFRA and Georgia common
         law require pesticide manufacturers to warn users of potential risks
         to health and safety.
               If anything, Georgia common law about failure-to-warn
         claims imposes less of a duty on pesticide manufacturers than
         FIFRA. Georgia common law requires manufacturers to warn of
USCA11 Case: 21-10994      Document: 178-1        Date Filed: 02/05/2024      Page: 16 of 31

         16                      Opinion of the Court                   21-10994

         nonobvious and foreseeable dangers of which they know or rea-
         sonably should know. See, e.g., Thornton, 22 F.3d at 289. By con-
         trast, FIFRA imposes a blanket duty on pesticide manufacturers,
         regardless of knowledge or foreseeability. Because Carson’s state
         failure-to-warn claim is “fully consistent with” or even narrower
         than federal requirements, FIFRA does not expressly preempt that
         claim. See Bates, 544 U.S. at 447; Hardeman v. Monsanto Co., 997 F.3d
         941, 955 (9th Cir. 2021) (“Because FIFRA’s misbranding require-
         ments parallel those of [the state’s] common law duty, [the plain-
         tiﬀ’s] failure-to-warn claims eﬀectively enforce FIFRA’s require-
         ment against misbranding and are thus not expressly preempted.”),
         cert. denied, 142 S. Ct. 2834 (2022). After all, as the Supreme Court
         has reasoned, “[w]hile such a narrower requirement might be ‘dif-
         ferent from’” FIFRA’s requirements “in a literal sense,” that would
         be “a strange reason for ﬁnding pre-emption of a state rule insofar
         as it duplicates” FIFRA. Bates, 544 U.S. at 547 (quoting Lohr, 518
         U.S. at 495). So FIFRA does not expressly preempt “narrower” state
         requirements.
         3. FIFRA’s registration process does not preempt Carson’s state-law fail-
                                     ure-to-warn claim.

                Monsanto argues that FIFRA’s “requirements” sweep far
         more broadly—namely, that FIFRA’s registration process itself car-
         ries preemptive eﬀect. In Monsanto’s view, the Agency’s approval
         of individual pesticide registrations and corresponding labels also
         qualify as “requirements” under FIFRA. In other words, Monsanto
         contends, because the Agency approved Roundup’s registration
USCA11 Case: 21-10994      Document: 178-1      Date Filed: 02/05/2024      Page: 17 of 31

         21-10994               Opinion of the Court                         17

         and re-registration, all state-law claims related to the registered la-
         bel are preempted. Carson responds that the Agency’s individual
         approvals are not “requirements” because they do not carry the
         force of law.
                We agree with Carson. As the en banc Court clariﬁed, we
         do not undertake a force-of-law analysis before interpreting an ex-
         press-preemption provision. See Carson III, 72 F.4th at 1267. As a
         congressionally enacted statute, FIFRA of course carries the force
         of law, and its plain text preempts state labeling requirements that
         are “in addition to or diﬀerent from” federal requirements. See 7
         U.S.C. § 136v(b).
                But the en banc Court left for us to consider whether “sec-
         tion 136v(b)’s reference to ‘requirements’ compels a force-of-law
         inquiry as a matter of statutory interpretation.” Carson III, 72 F.4th
         at 1268. To establish whether a particular Agency action amounts
         to a “requirement” under FIFRA, we must determine whether that
         Agency action carries the force of law. If it is not “a rule of law
         that must be obeyed,” then as the Supreme Court has directed, it is
         not a “requirement.” Bates, 544 U.S. at 445. So though we need not
         perform a threshold force-of-law analysis before deﬁning the scope
         of FIFRA’s preemption, we must do that analysis to determine
         whether an Agency action qualiﬁes as a “requirement.”
                We “assume . . . that Congress contemplates administrative
         action with the eﬀect of law when it provides for a relatively formal
         administrative procedure[.]” United States v. Mead Corp., 533 U.S.
         218, 230 (2001). That category includes “notice-and-comment
USCA11 Case: 21-10994      Document: 178-1      Date Filed: 02/05/2024      Page: 18 of 31

         18                     Opinion of the Court                  21-10994

         rulemaking or formal adjudication,” id., but may extend to other
         processes, like cancellation proceedings, as well. Our analysis,
         then, turns on whether the FIFRA registration process is “relatively
         formal,” id., and creates “a rule of law that must be obeyed,” Bates,
         544 U.S. at 445. If it is not, it does not carry the force of law and
         cannot preempt state-law duties.
                On the record before us, we have little trouble concluding
         that the Agency’s individual approvals are not “requirements” un-
         der FIFRA. FIFRA sets forth “broadly phrased misbranding stand-
         ards.” Bates, 544 U.S. at 453 n.28. Agency regulations, promulgated
         after notice and comment, “give content to” those standards. Id. at
         453. And Congress has given the Agency the authority to deter-
         mine whether a particular pesticide’s label complies with those
         broad standards. But we cannot conﬂate FIFRA’s broad prohibition
         on misbranding—indisputably a “requirement”—or even generally
         applicable agency regulations, with an individualized ﬁnding that a
         particular pesticide is not misbranded.
                 This is especially true because Agency approvals provide
         only “prima facie evidence,” not conclusive proof, that a pesticide
         is not misbranded. See 7 U.S.C. § 136a(f )(2); Hardeman, 997 F.3d at
         956. Indeed, FIFRA speciﬁes that “[i]n no event shall registration .
         . . be construed as a defense for the commission of any oﬀense un-
         der” its provisions. 7 U.S.C. § 136a(f )(2). By approving a pesticide’s
         registration, the Agency signals that the pesticide “compl[ies] with”
         FIFRA’s “requirements,” 7 U.S.C. § 136a(c)(5)(B), but it does not im-
         pose any new requirements beyond FIFRA’s. And signiﬁcantly, the
USCA11 Case: 21-10994      Document: 178-1      Date Filed: 02/05/2024     Page: 19 of 31

         21-10994               Opinion of the Court                        19

         Agency can later retract its approval. Since the Agency’s determi-
         nation is neither conclusive nor irrevocable, it would make little
         sense to deem it a “requirement” on equal footing with FIFRA’s
         prohibition on misbranding. See Hardeman, 997 F.3d at 956
         (“[B]ecause EPA’s labeling determinations are not dispositive of
         FIFRA compliance, they similarly are not conclusive as to which
         common law requirements are ‘in addition to or diﬀerent from’ the
         requirements imposed by FIFRA.”).
                 Still, though, Monsanto argues that registration under
         FIFRA preempts state-law claims. For support, Monsanto relies on
         Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).
                Riegel concerned the “rigorous” pre-market approval process
         for medical devices under the Medical Device Amendments
         (“Amendments”) to the Federal Food, Drug, and Cosmetic Act—a
         statute that the Federal Food and Drug Administration (“FDA”) ad-
         ministers. Id. at 317. To initiate the pre-market approval process
         under the Amendments, a medical-device “manufacturer must sub-
         mit what is typically a multivolume application,” including “full re-
         ports of all studies and investigations of the device’s safety and ef-
         fectiveness that have been published or should reasonably be
         known to the applicant.” Id. at 318 (citing 21 U.S.C. § 360e(c)(1)).
         The FDA “spends an average of 1,200 hours reviewing each appli-
         cation,” id., and grants premarket approval only if it ﬁnds a “rea-
         sonable assurance” of the device’s “safety and eﬀectiveness,” 21
         U.S.C. § 360e(d). As part of that process, the FDA must determine
         that the device’s proposed label is not false or misleading. Id.
USCA11 Case: 21-10994     Document: 178-1      Date Filed: 02/05/2024     Page: 20 of 31

         20                     Opinion of the Court                21-10994

         § 360e(d)(1)(A). Once a device has received premarket approval,
         the manufacturer cannot change its label (or anything else that
         would aﬀect the device’s safety or eﬀectiveness) without the FDA’s
         permission. Id. § 360e(d)(5)(A)(i).
                In Riegel, the plaintiﬀs brought common-law strict-liability,
         breach-of-implied-warranty, and negligence claims against a cathe-
         ter manufacturer, including over the device’s labeling. 552 U.S. at
         320. The Supreme Court concluded that the Amendments ex-
         pressly preempted those state-law claims. Like FIFRA, the Amend-
         ments to the Federal Food, Drug, and Cosmetic Act contain an ex-
         press-preemption clause: no State “may establish or continue in ef-
         fect with respect to a device . . . any requirement—(1) which is dif-
         ferent from, or in addition to, any requirement applicable under
         [the Amendments] to the device, and (2) which relates to the safety
         or eﬀectiveness of the device . . . .” 21 U.S.C. § 360k(a).
                 As we do here, the Supreme Court interpreted the term “re-
         quirement” within the Amendments’ preemption provision. The
         Court concluded that the premarket approval process imposed “re-
         quirement[s] relating to safety [and] eﬀectiveness” because, after
         the FDA grants premarket approval, the manufacturer can make
         “almost no deviations” (including labeling) from its application.
         Riegel, 552 U.S. at 323, 328. And, the Court reasoned, because the
         plaintiﬀs’ tort claims concerned the device’s “safety and eﬀective-
         ness,” they fell within the scope of the Amendments’ preemption
         provision. Id. at 327–29. But because the plaintiﬀs had not fully
         briefed it, the Court declined to address whether the plaintiﬀs’
USCA11 Case: 21-10994     Document: 178-1      Date Filed: 02/05/2024     Page: 21 of 31

         21-10994               Opinion of the Court                       21

         state-law claims imposed “parallel” requirements to those of the
         Amendments. Id. at 330.
                 We think the diﬀerences between Riegel and the circum-
         stances here show why the Agency’s individualized determinations
         about a particular pesticide do not qualify as “requirement[s].”
         First, the Riegel Court expressly declined to consider whether state
         tort law imposed parallel requirements to the Amendments’ fed-
         eral requirements. Id. Here, that question is before us, and, as
         we’ve explained, Georgia common law parallels FIFRA’s labeling
         requirements.
                Second, and more importantly, FIFRA’s statutory scheme
         diﬀers from the Amendments’. Again, FIFRA “authorizes a rela-
         tively decentralized scheme that preserves a broad role for state
         regulation.” Bates, 544 U.S. at 450. By contrast, the Amendments’
         scheme is decidedly centralized: the Federal Food, Drug, and Cos-
         metics Act Amendments “swept back . . . state obligations and im-
         posed a regime of detailed federal oversight.” Riegel, 552 U.S. at
         316. So while the preemption provisions are similar, we must read
         them in context.
                 The statutes’ distinct approval processes conﬁrm this signif-
         icant diﬀerence. Premarket approval under the Amendments rep-
         resents a “rigorous” conclusion that a device is safe and eﬀective.
         See id. at 317–18. Once the FDA has approved a device, manufac-
         turers cannot change a device’s label (or design, etc.) without the
         FDA’s permission. See 21 U.S.C. § 360e(d)(5)(A)(i). By contrast, the
         Agency’s approval of a pesticide’s registration serves as only “prima
USCA11 Case: 21-10994      Document: 178-1        Date Filed: 02/05/2024     Page: 22 of 31

         22                      Opinion of the Court                   21-10994

         facie evidence” that the pesticide complies with FIFRA’s require-
         ments. 7 U.S.C. § 136a(f )(2). And through its ongoing reporting
         requirements, “FIFRA contemplates that pesticide labels will
         evolve over time, as manufacturers gain more information about
         their products’ performance in diverse settings.” Bates, 544 U.S. at
         451. As the Supreme Court has reasoned, state tort litigation “may
         lead manufacturers to petition [the] [Agency] to allow more de-
         tailed labelling of their products,” or the Agency “itself may decide
         that revised labels are required in light of ” the litigation. Id. at 451
         (quoting Ferebee v. Chevron Chem. Co., 736 F.2d 1529, 1541 (D.C. Cir.
         1984)).
                What’s more, the Amendments’ preemption provision ex-
         pressly contemplates device-speciﬁc application, as it preempts re-
         quirements “with respect to a device.” 21 U.S.C. § 360k(a). FIFRA,
         on the other hand, contains no such limitation—it imposes only
         “general standards.” Bates, 544 U.S. at 453 n.27. And “diﬀerent fed-
         eral statutes and regulations may . . . lead to diﬀerent preemption
         results.” PLIVA, Inc. v. Mensing, 564 U.S. 604, 626 (2011).
                 Given the diﬀerences between FIFRA and the Amendments’
         statutory schemes, Riegel does not control here. And we conclude
         that neither FIFRA’s labeling requirements nor the Agency’s regis-
         tration process preempts Carson’s state-law failure-to-warn claim.
         After all, given “the long history of tort litigation,” it “seems un-
         likely that Congress considered a relatively obscure provision like
         [section] 136v(b) to give pesticide manufacturers virtual immunity
         from certain forms of tort liability.” Bates, 544 U.S. at 449–50.
USCA11 Case: 21-10994      Document: 178-1      Date Filed: 02/05/2024     Page: 23 of 31

         21-10994               Opinion of the Court                        23

         Rather, FIFRA expressly contemplates a role for states in pesticide
         regulation, and that role includes common-law claims that parallel
         FIFRA’s requirements. See id. at 447.
               At bottom, we conclude that FIFRA does not expressly
         preempt Carson’s state-law failure-to-warn claim, so Monsanto was
         not entitled to judgment on the pleadings on this ground.
           4. No other Agency action preempts Carson’s failure-to-warn claim.

               Monsanto also points to other Agency actions that it claims
         have preemptive eﬀect. We are not convinced.
                For instance, Monsanto cites the Agency’s interim registra-
         tion reviews and re-registration eligibility decision for glyphosate-
         containing pesticides (“Agency’s 2020 Interim Decision”), as well as
         accompanying comments. See, e.g., EPA, Reregistration Eligibility
         Decision (RED) – Glyphosate (Sept. 1993); EPA, Glyphosate: In-
         terim Registration Review Decision Case No. 0178 ( Jan. 2020);
         EPA, Response from the Pesticide Re-evaluation Division (PRD) to
         Comments on the Glyphosate Proposed Interim Decision ( Jan. 16,
         2020).
                But the Ninth Circuit vacated the human-health portion of
         the Agency’s 2020 Interim Decision as arbitrary and “not supported
         by substantial evidence.” Nat. Res. Def. Council v. U.S. Env’t Prot.
         Agency, 38 F.4th 34, 51–52 (9th Cir. 2022). And the Agency with-
         drew “all remaining portions of the interim registration review de-
         cision for glyphosate” in 2022. EPA, EPA Withdraws Glyphosate
USCA11 Case: 21-10994         Document: 178-1         Date Filed: 02/05/2024         Page: 24 of 31

         24                         Opinion of the Court                       21-10994

         Interim Decision (Sept. 23, 2022). 1 So, that 2020 determination can-
         not carry the force of law or any preemptive eﬀect. See, e.g., Kia-
         kombua v. Wolf, 498 F. Supp. 3d 1, 50 (D.D.C. 2020) ( Jackson, J.) (“In
         essence, a vacatur order takes the unlawful agency action oﬀ the
         books[.]” (citation and internal quotation marks omitted)).
                Monsanto also relies on a 2019 Agency letter concluding that
         glyphosate is “not likely to be carcinogenic to humans” and that
         California’s warning of glyphosate’s potential carcinogenic eﬀects
         was “false or misleading.” EPA, Letter to Glyphosate Registrants
         Regarding Labeling Requirements (Aug. 7, 2019). We note that the
         Agency issued the 2019 letter after Carson was diagnosed with can-
         cer and ﬁled this lawsuit. And while the letter rejected California’s
         speciﬁc Proposition 65 warning, it did not foreclose any and all
         warnings related to glyphosate’s potentially harmful eﬀects.
                  In any event, the 2019 letter did not carry the force of law
         because it neither reﬂected suﬃcient formality, Mead, 533 U.S. at
         230, nor created “a rule of law that must be obeyed.” Bates, 544
         U.S. at 445. Rather, the Agency issued the letter “without any writ-
         ten notice, gave no hearing or opportunity to respond, and lacked
         any sort of dispute-resolution process.” Hardeman, 997 F.3d at 957;
         cf. Fellner v. Tri-Union Seafoods, L.L.C., 539 F.3d 237, 255 (3d Cir. 2008)
         (ﬁnding, in the implied-preemption context, no preemptive eﬀect

         1 In its announcement of the withdrawal, the EPA nonetheless reiterated “its

         finding that glyphosate is not likely to be carcinogenic to humans” but noted
         that it “intends to revisit and better explain its evaluation of the carcinogenic
         potential of glyphosate.” Id.
USCA11 Case: 21-10994       Document: 178-1      Date Filed: 02/05/2024      Page: 25 of 31

         21-10994                Opinion of the Court                            25

         where the agency “merely expressed an informal policy opinion in
         a letter, and it did so only after [the plaintiﬀ’s] injuries were alleg-
         edly suﬀered”). So the 2019 letter does not expressly preempt Car-
         son’s state-law failure-to-warn claims.
                For similar reasons, we reject Monsanto’s arguments that
         Agency scientiﬁc papers or letters from Agency oﬃcials about
         glyphosate’s potentially carcinogenic eﬀects (or lack thereof ) carry
         preemptive eﬀect. See, e.g., EPA, Health Eﬀects Div., Second Peer
         Review of Glyphosate (Oct. 30, 1991); EPA, Oﬃce of Pesticide Pro-
         grams, Revised Glyphosate Issue Paper: Evaluation of Carcino-
         genic Potential (Dec. 12, 2017). In short, we conclude that neither
         FIFRA nor any other Agency action imposes “requirements” that
         would preempt Carson’s state-law failure-to-warn claim.
              B.    Carson’s failure-to-warn claim is not impliedly preempted.

                Though we ﬁnd no express preemption, our preemption in-
         quiry does not end there. Monsanto contends that Carson’s claims
         are “independently barred by impossibility preemption” because
         Monsanto “could not have added a cancer warning to the Roundup
         label over [the] [Agency’s] objection.” In fact, Monsanto claims, the
         Agency would not have approved a warning label stating that
         glyphosate may be carcinogenic to humans, so Monsanto could not
         comply with both federal directives and Georgia common-law du-
         ties.
USCA11 Case: 21-10994        Document: 178-1        Date Filed: 02/05/2024       Page: 26 of 31

         26                       Opinion of the Court                     21-10994

                 The district court did not rule on Monsanto’s implied-
         preemption defense to Carson’s failure-to-warn claim,2 as it con-
         cluded that Monsanto prevailed on its express-preemption argu-
         ment. See Carson I, 508 F. Supp. 3d at 1377–78. But as we’ve noted,
         we reach a diﬀerent answer on the express-preemption issue. And
         as it turns out, the parties have briefed the implied-preemption is-
         sue before us. Because the resolution of that issue is clear, we de-
         cide it. See LaCroix v. Town of Fort Myers Beach, 38 F.4th 941, 954
         (11th Cir. 2022).

                 Implied preemption occurs when “it is ‘impossible for a pri-
         vate party to comply with both state and federal requirements.’”
         Mensing, 564 U.S. at 618 (quoting Freightliner Corp. v. Myrick, 514 U.S.
         280, 287 (1995)). The mere “possibility of impossibility [is] not
         enough.” Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668,
         1678 (2019) (alteration in original) (quoting Mensing, 564 U.S. at 625
         n.8). Rather, the state and federal laws must “irreconcilably con-
         ﬂic[t].” Id. at 1679 (alteration in original) (citation omitted).

                To show an “irreconcilabl[e] conﬂict” that would bar Car-
         son’s failure-to-warn claim, Monsanto must present “clear evi-
         dence” that (1) Monsanto “fully informed” the Agency of “the jus-
         tiﬁcations for the warning” that Georgia state law would impose;
         (2) the Agency “informed [Monsanto] that [it] would not approve

         2 The district court considered only whether impossibility preemption barred

         Carson’s remaining design-defect (Count I) and negligence (Count III) claims.
         See Carson I, 508 F. Supp. 3d at 1378.
USCA11 Case: 21-10994      Document: 178-1      Date Filed: 02/05/2024     Page: 27 of 31

         21-10994               Opinion of the Court                        27

         changing the . . . label to include that warning”; and (3) the Agency
         undertook its action “pursuant to . . . congressionally delegated au-
         thority” in a way that “carr[ies] the force of law.” Id. at 1678–79
         (citation and internal quotation marks omitted). The Supreme
         Court has characterized this burden as “demanding.” Wyeth v. Lev-
         ine, 555 U.S. 555, 573 (2009).

                As a threshold matter, Carson argues that implied preemp-
         tion is not an available defense given FIFRA’s express-preemption
         provision. Cf. Mortier, 501 U.S. at 613 (1991) (ﬁnding that FIFRA
         does not “otherwise imply pre-emption” beyond section 136v(b));
         Graham v. R.J. Reynolds Tobacco Co., 857 F.3d 1169, 1189 (11th Cir.
         2017) (reasoning that the fact that “the express-preemption provi-
         sion” at issue “does not cover the” substance of the plaintiﬀs’ claims
         “supports an inference that there is no implied preemption of
         those” claims). But we need not resolve that question, because
         even if implied preemption is available, Monsanto has not satisﬁed
         its burden here.

                Monsanto relies on the Agency actions we’ve already
         noted—chieﬂy, the Agency’s 1993 determination that glyphosate
         met FIFRA’s requirements for re-registration and its 2019 letter say-
         ing that California’s cancer warning for glyphosate would be a
         “false and misleading statement” in violation of FIFRA. These ac-
         tions don’t meet the “demanding” standard for impossibility
         preemption.
USCA11 Case: 21-10994      Document: 178-1      Date Filed: 02/05/2024     Page: 28 of 31

         28                     Opinion of the Court                 21-10994

                First, the Agency’s registration, interim registration review,
         and re-registration of glyphosate without a cancer warning do not
         show that a cancer warning would be impossible. Put diﬀerently,
         the Agency’s repeated approvals of a label without a cancer warn-
         ing do not mean the Agency necessarily would have rejected a label
         with a cancer warning.

                 Nor does the Agency’s concurrent classiﬁcation of glypho-
         sate as not likely to be carcinogenic to humans alter this conclusion.
         Based on the record before us, Monsanto did not request—and the
         Agency did not consider, much less reject—a cancer warning at all.
         So Monsanto cannot meet its burden to show that the Agency “in-
         formed [Monsanto] that [it] would not approve changing the . . . la-
         bel to include that warning,” and impossibility preemption does
         not apply. See Merck, 139 S. Ct. at 1678.

                 Our conclusion is the same for the Agency’s 2019 letter: the
         Agency action does not meet the “demanding” requirements for
         impossibility preemption. Of course, the Agency issued the 2019
         letter after Carson was diagnosed with cancer and ﬁled this lawsuit,
         so it does not necessarily reﬂect the Agency’s position during the
         time Carson used Roundup. But even if it did, the 2019 letter was
         directed at California’s speciﬁc Proposition 65 warning and did not
         conclude that any and all warnings related to glyphosate’s potential
         cancerous eﬀects would render a pesticide “misbranded.” That is
         not enough for impossibility preemption. See Merck, 139 S. Ct. at
         1678 (“The underlying question for this type of impossibility pre-
         emption defense is whether federal law . . . prohibited the [product]
USCA11 Case: 21-10994     Document: 178-1      Date Filed: 02/05/2024     Page: 29 of 31

         21-10994               Opinion of the Court                       29

         manufacturer from adding any and all warnings to the [product]
         label that would satisfy state law.”).

                 Monsanto also can’t point to caselaw from the Supreme
         Court or this Court that compels preemption. To be sure, in Mens-
         ing, the Supreme Court found that impossibility preemption barred
         the plaintiﬀs’ state-law claims. 564 U.S. at 618. But Mensing is ma-
         terially distinguishable from this case.

                In Mensing, the prescription-drug manufacturers could not
         change their labels in the way the plaintiﬀs sought because the drug
         was a generic version of a name-brand drug. See id. at 612, 618.
         And under federal law, generic drugs must carry the same labels as
         their name-brand equivalents, so the generic-brand manufacturers
         could not unilaterally change their labels if the name-brand label
         stayed the same. Id. at 618; see also 21 U.S.C. § 355(j)(4)(G); 21
         C.F.R. § 314.150(b)(10). If, in fact, the generic-brand manufacturers
         “independently changed their labels to satisfy their state-law duty,
         they would have violated federal law.” Id. As a result, the generic-
         brand manufacturers in Mensing could not comply with both fed-
         eral and state-common-law requirements. Id. This conﬂict trans-
         cended the mere “possibility of impossibility.” See id. at 625 n.8.
         And that required the Court to ﬁnd implied preemption. Id. at 618.
         But here, Roundup’s label was not dependent on that of any other
         pesticide. And Monsanto cannot show that a cancer warning
USCA11 Case: 21-10994       Document: 178-1        Date Filed: 02/05/2024      Page: 30 of 31

         30                       Opinion of the Court                    21-10994

         “would have violated federal law.” See id. So Mensing does not lend
         any support to Monsanto’s claims.3

                What’s more, in 2022, the Agency publicly stated that it
         “could approve” warning language that “[t]he International
         Agency for Research on Cancer classiﬁed glyphosate as probably
         carcinogenic to humans,” and products with that warning “would
         not be considered misbranded.” EPA, Response to California’s Of-
         ﬁce of Environmental Health Hazard Assessment on California’s
         Proposition 65 (Apr. 8, 2022). To be sure, the Agency expressed this
         position years after Carson ﬁled his lawsuit. But it still undercuts
         Monsanto’s claim of impossibility. If, in the Agency’s own words,
         it “could approve” a warning similar to the one Carson seeks, and
         products with a warning like that would not be “misbranded” un-
         der FIFRA, Monsanto could comply with both state and federal la-
         beling requirements. See also Hardeman, 997 F.3d at 959 (noting that
         the Agency “has repeatedly permitted pesticide manufacturers to
         use the notiﬁcation procedure to add notices related to cancer to
         their products’ labels”). And no “irreconcilabl[e] conﬂict” exists.
         As a result, FIFRA does not impliedly preempt the warning that
         Georgia law would require. See Merck, 139 S. Ct. at 1679.
              Finally, and in any event, as we’ve explained, none of the
         Agency’s actions on which Monsanto relies carry the force of law.

         3 We note also that Mensing did not involve express preemption, as Congress

         has “declined to enact [an express-preemption] provision for prescription
         drugs.” Wyeth, 555 at 567.
USCA11 Case: 21-10994     Document: 178-1      Date Filed: 02/05/2024    Page: 31 of 31

         21-10994              Opinion of the Court                       31

         See Mead, 533 U.S. at 230; Hardeman, 997 F.3d at 960. So even if the
         Agency’s actions satisﬁed the ﬁrst two requirements for impossibil-
         ity preemption—and as we’ve explained, they do not—they fail to
         meet this third requirement. See Merck, 139 S. Ct. at 1679. Because
         Monsanto has not carried its burden of proving impossibility, we
         conclude that implied preemption does not bar Carson’s state-law
         failure-to-warn claim.

                               IV. CONCLUSION
                For the reasons we’ve explained, we vacate the district
         court’s conclusion that FIFRA expressly preempts Carson’s failure-
         to-warn claim, hold that neither FIFRA nor any Agency action im-
         pliedly preempts Carson’s failure-to-warn claim, and remand for
         further proceedings consistent with this opinion.
               VACATED AND REMANDED.