throbber
 No. 21-241
`In the Supreme Court of the United States
`
`
`
`MONSANTO COMPANY, PETITIONER
`v.
`EDWIN HARDEMAN
`
`
`
`ON PETITION FOR A WRIT OF CERTIORARI
`TO THE UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`
`
`
`BRIEF FOR THE UNITED STATES AS AMICUS CURIAE
`
`
`
` ELIZABETH B. PRELOGAR
`Solicitor General
`Counsel of Record
`TODD KIM
`Assistant Attorney General
`MALCOLM L. STEWART
`Deputy Solicitor General
`YAIRA DUBIN
`Assistant to the Solicitor
`General
`MATTHEW R. OAKES
`Attorney
`Department of Justice
`Washington, D.C. 20530-0001
`SupremeCtBriefs@usdoj.gov
`(202) 514-2217
`
`
`
`
`
`
`

`

`QUESTIONS PRESENTED
`1. Whether the Federal Insecticide, Fungicide, and
`Rodenticide Act, 7 U.S.C. 136 et seq., preempts re-
`spondent’s state-law claims alleging that petitioner tor-
`tiously failed to warn of the carcinogenic risks associ-
`ated with its pesticide product.
`2. Whether the district court abused its discretion in
`admitting expert medical testimony that relied in part
`on clinical experience.
`
`(I)
`
`

`

`TABLE OF CONTENTS
`
`Page
`Statement ...................................................................................... 1
`Discussion ...................................................................................... 6
`I. The preemption question does not warrant review ..... 6
`A. The court of appeals correctly held that
`FIFRA does not preempt respondent’s
`state-law failure-to-warn claims .............................. 6
`1. FIFRA does not expressly preempt
`respondent’s state-law failure-to-warn
`claims ................................................................... 7
`2. FIFRA does not impliedly preempt
`respondent’s state-law claims .......................... 14
`B. Further review is not warranted ........................... 17
`II. The court of appeals’ evidentiary ruling does not
`warrant review ............................................................... 20
`Conclusion ................................................................................... 24
`
`TABLE OF AUTHORITIES
`
`
`
`Cases:
`Bates v. Dow Agrosciences LLC,
`544 U.S. 431 (2005)..................................................... passim
`Bland v. Verizon Wireless, (VAW) L.L.C.,
`538 F.3d 893 (8th Cir. 2008) ............................................... 22
`Crosby v. National Foreign Trade Council,
`530 U.S. 363 (2000).............................................................. 14
`Daubert v. Merrell Dow Pharm., Inc.,
`509 U.S. 579 (1993).......................................................... 5, 20
`Hall v. Conoco, Inc.,
`886 F.3d 1308 (10th Cir. 2018) ........................................... 22
`PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) .............. 15, 16
`Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) ............. 18, 19
`
`
`
`(III)
`
`

`

`IV
`
`Cases—Continued:
`Tamraz v. Lincoln Elec. Co.,
`620 F.3d 665 (6th Cir. 2010), cert. denied,
`563 U.S. 988 (2011)........................................................ 20, 21
`Wyeth v. Levine, 555 U.S. 555 (2009) .................................. 15
`
`Page
`
`Statutes, regulations, and rules:
`Federal Insecticide, Fungicide, and Rodenticide Act,
`7 U.S.C. 136 et seq. ................................................................ 1
`7 U.S.C. 136(q)(1)(A) ......................................................... 2
`7 U.S.C. 136(q)(1)(G) ............................................... 2, 8, 11
`7 U.S.C. 136(bb) ........................................................... 2, 12
`7 U.S.C. 136a(a) ................................................................. 1
`7 U.S.C. 136a(c)(1)(C) ....................................................... 1
`7 U.S.C. 136a(c)(1)(D) ....................................................... 1
`7 U.S.C. 136a(c)(1)(F) ....................................................... 1
`7 U.S.C. 136a(c)(5)(B) ....................................................... 2
`7 U.S.C. 136a(c)(5)(D) ....................................................... 2
`7 U.S.C. 136a(f )(2) ................................................... 2, 8, 17
`7 U.S.C. 136a(g)(1)(A) ....................................................... 2
`7 U.S.C. 136j(a)(1)(E) ........................................................ 2
`7 U.S.C. 136j(a)(2)(G) ...................................................... 10
`7 U.S.C. 136v(a) ................................................................. 3
`7 U.S.C. 136v(b) ...................................................... passim
`7 U.S.C. 136v(c)(1) ............................................................. 3
`Medical Device Amendments of 1976,
`21 U.S.C. 360k(a) ................................................................ 18
`Safe Drinking Water and Toxic Enforcement Act of
`1986, Cal. Health & Safety Code (West 2006):
`§ 25249.5 ............................................................................. 3
`§ 25249.6 ............................................................................. 3
`§ 25249.7 (West Supp. 2022) ............................................. 3
`
`
`
`

`

`V
`
`Page
`Statutes, regulations, and rules—Continued:
`§§ 25249.8-25249.13 ........................................................... 3
`§ 25249.8(b) ........................................................................ 4
`§ 25249.11 ......................................................................... 20
`§ 25249.14 (West Supp. 2022) ........................................... 3
`40 C.F.R.:
`Section 156.10(i)(2)(ii) ..................................................... 10
`Section 156.62 (2004) ....................................................... 18
`Section 156.64 (2004) ....................................................... 18
`Section 156.70(b) .............................................................. 11
`Section 158.130(d)(1) ....................................................... 11
`Fed. R. Evid.:
`Rule 702 ............................................................... 20, 22, 23
`Rule 702(a) ....................................................................... 23
`Rule 702(d) ....................................................................... 23
`
`Miscellaneous:
`Comm. on Rules of Practice & Procedure, Judicial
`Conf. of the U.S., Preliminary Draft: Proposed
`Amendments to the Federal Rules of Appellate,
`Bankruptcy, Civil, and Criminal Procedure, and
`the Federal Rules of Evidence (Aug. 6, 2021),
`https://www.uscourts.gov/rules-policies/
`pending-rules-and-forms-amendments ............................ 23
`EPA:
`Glyphosate: Interim Registration Review
`Decision, Case Number 0178 (Jan. 22, 2020),
`https://www.epa.gov/sites/default/files/
`2020-01/documents/glyphosate-interim-
`reg-review-decision-case-num-0178.pdf .................. 13
`Label Review Manual (rev. Mar. 2018),
`https://www.epa.gov/pesticide-registration/
`label-review-manual .................................................. 11
`
`
`
`

`

`VI
`
`Page
`
`Miscellaneous—Continued:
`Letter from Michal Freedhoff, Assistant Adm’r,
`Office of Chem. Safety & Pollution Prevention,
`EPA, to Lauren Zeise, Dir., Office of Envtl. Health
`Hazard Assessment, Cal. Envtl. Prot. Agency
`(Apr. 8, 2022), https://oehha.ca.gov/media/
`downloads/crnr/usepaaafreedhofftooehhadirzeise-
`glyphosate40822.pdf ..................................................... 14, 16
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`In the Supreme Court of the United States
`
`
`
`No. 21-241
`MONSANTO COMPANY, PETITIONER
`v.
`EDWIN HARDEMAN
`
`
`
`ON PETITION FOR A WRIT OF CERTIORARI
`TO THE UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`
`
`
`BRIEF FOR THE UNITED STATES AS AMICUS CURIAE
`
`
`
`This brief is submitted in response to the Court’s or-
`der inviting the Solicitor General to express the views
`of the United States. In the view of the United States,
`the petition for a writ of certiorari should be denied.
`STATEMENT
`1. a. The Federal Insecticide, Fungicide, and Ro-
`denticide Act (FIFRA or Act), 7 U.S.C. 136 et seq., pro-
`hibits the distribution or sale of a pesticide “that is not
`registered” by the United States Environmental Pro-
`tection Agency (EPA). 7 U.S.C. 136a(a). To apply for
`registration, a manufacturer must submit, among other
`things, the product’s “complete formula,” “claims to be
`made for it,” proposed labeling, and a “full description
`of the tests made and the results thereof upon which the
`claims are based.” 7 U.S.C. 136a(c)(1)(C), (D), and (F).
`EPA “shall register a pesticide” if the agency deter-
`mines, inter alia, that the pesticide is efficacious; that
`
`(1)
`
`

`

`2
`
`its labeling * * * compl[ies] with the requirements of
`this subchapter”; and that “when used in accordance
`with widespread and commonly recognized practice[,] it
`will not generally cause unreasonable adverse effects on
`the environment.” 7 U.S.C. 136a(c)(5)(B) and (D).
`FIFRA defines “unreasonable adverse effects” to in-
`clude “any unreasonable risk to man or the environ-
`ment, taking into account the economic, social, and en-
`vironmental costs and benefits of the use of any pesti-
`cide.” 7 U.S.C. 136(bb). EPA must review a pesticide’s
`registration every 15 years. 7 U.S.C. 136a(g)(1)(A).
`“As long as no cancellation proceedings are in ef-
`fect,” registration of a particular pesticide “shall be
`prima facie evidence that the pesticide, its labeling and
`packaging comply with [FIFRA’s] registration provi-
`sions.” 7 U.S.C. 136a(f )(2). Registration cannot “be
`construed as a defense for the commission of any of-
`fense under” FIFRA. Ibid.
`b. FIFRA prohibits the sale or distribution of a pes-
`ticide that is “misbranded.” 7 U.S.C. 136j(a)(1)(E). A pes-
`ticide is misbranded if its labeling “bears any statement
`* * * which is false or misleading in any particular.”
`7 U.S.C. 136(q)(1)(A). A pesticide is also misbranded if it
`“does not contain a warning or caution statement which
`may be necessary and if complied with * * * is adequate
`to protect health and the environment.” 7 U.S.C.
`136(q)(1)(G). “Because it is unlawful under the statute to
`sell a pesticide that is registered but nevertheless mis-
`branded, manufacturers have a continuing obligation to
`adhere to FIFRA’s labeling requirements,” including by
`seeking EPA approval to amend a label that does not con-
`tain all “necessary warnings or cautionary statements.”
`Bates v. Dow Agrosciences LLC, 544 U.S. 431, 438-439
`(2005).
`
`
`
`

`

`3
`
`c. “In general,” a State may “regulate the sale or use
`of any federally registered pesticide” within its borders,
`so long as “the regulation does not permit any sale or use
`prohibited by” FIFRA. 7 U.S.C. 136v(a) (emphasis omit-
`ted). In certain circumstances, a State may also “provide
`registration for additional uses of federally registered
`pesticides” in order “to meet special local needs” “within
`such State.” 7 U.S.C. 136v(c)(1). In the interest of “[u]ni-
`formity,” however, a State may not “impose or continue in
`effect any requirements for labeling or packaging in addi-
`tion to or different from those required under” FIFRA.
`7 U.S.C. 136v(b) (emphasis omitted).
`
`2. Petitioner “Monsanto Company manufactures
`Roundup, a pesticide with the active ingredient glypho-
`sate.” Pet. App. 2a. EPA has registered pesticides con-
`taining glyphosate since 1974. Id. at 4a. In 1985, EPA
`classified glyphosate as a possible human carcinogen
`based on kidney tumors observed in a study of effects
`on mice. Ibid. Since then, however, EPA has repeat-
`edly concluded that glyphosate is unlikely to cause can-
`cer in humans. Ibid. Roundup’s EPA-approved prod-
`uct label does not currently contain a warning that
`glyphosate may pose a cancer risk to humans. See id.
`at 14a.
`
`In 2015, a working group at the International Agency
`for Research on Cancer (IARC) classified glyphosate as
`a possible human carcinogen. Pet. App. 5a. Under Cal-
`ifornia’s Safe Drinking Water and Toxic Enforcement
`Act of 1986, Cal. Health & Safety Code §§ 25249.5,
`25249.6, 25249.8-25249.13 (West 2006); id. §§ 25249.7,
`25249.14 (West Supp. 2022), known as Proposition 65, a
`substance must be accompanied by a warning “if a body
`considered to be authoritative by” state experts (which
`includes IARC) “has formally identified” the substance
`
`
`
`

`

`4
`
`“as causing cancer,” id. § 25249.8(b) (West 2006). In
`2017, based on the IARC finding, California “catego-
`rized glyphosate as a chemical known to the state to
`cause cancer.” Pet. App. 5a-6a.
`
`In response, several registrants sought EPA ap-
`proval to amend the labels of glyphosate-containing
`products to include a statement that California had de-
`termined that glyphosate may cause cancer. See Gov’t
`C.A. Amicus Br. 10. EPA initially approved some of
`these requests, allowing manufacturers to include a
`cancer warning in the “Optional Marketing State-
`ments” section of those product labels. Id. at 10, 18-19
`n.14. In 2019, however, the Director of the Registration
`Division of EPA’s Office of Pesticide Programs issued a
`letter to registrants of glyphosate-containing products
`addressing the Proposition 65 default language. Pet.
`App. 195a-197a. The letter stated that, because EPA
`had determined that glyphosate is “ ‘not likely to be car-
`cinogenic to humans,’ * * * pesticide products bearing
`the Proposition 65 warning statement due to the pres-
`ence of glyphosate are misbranded” under FIFRA. Id.
`at 196a.
`3. In 2015, respondent Edwin Hardeman was diag-
`nosed with non-Hodgkin’s lymphoma. Pet. App. 7a. In
`2016, he sued petitioner, alleging that his use of
`Roundup from the mid-1980s to 2012 had caused his
`cancer. Ibid. Respondent alleged, inter alia, that peti-
`tioner had tortiously failed to warn of cancer risks
`posed by Roundup.
`Before trial, the district court rejected petitioner’s
`argument that FIFRA preempted the failure-to-warn
`claims. Pet. App. 7a. At trial, over petitioner’s objec-
`tion, the district court admitted medical testimony on
`disease causation from three of respondent’s experts.
`
`
`
`

`

`5
`
`Id. at 8a. The jury returned a verdict in respondent’s
`favor on the failure-to-warn claims, concluding that
`Roundup exposure was a “substantial factor” in causing
`his cancer and that petitioner had failed to warn of the
`carcinogenic risks associated with Roundup. Id. at 10a.
`4. The court of appeals affirmed. Pet. App. 1a-69a.
`a. The court of appeals held that FIFRA does not
`preempt respondent’s failure-to-warn claims. The
`court explained that, “[b]ecause FIFRA’s misbranding
`requirements parallel those of California’s common law
`duty, [respondent’s] failure-to-warn claims effectively
`enforce FIFRA’s requirement against misbranding and
`are thus not expressly preempted.” Pet. App. 13a. The
`court rejected petitioner’s argument that EPA’s regis-
`tration of Roundup without a cancer warning on the la-
`bel preempts any state-law rule requiring such a warn-
`ing. Id. at 14a. The court explained that a pesticide can
`be misbranded even if it has been registered because
`EPA’s approval of a label is prima facie but not conclu-
`sive evidence of FIFRA compliance. Id. at 14a-15a. The
`court further held that neither EPA’s approval of
`Roundup’s label nor EPA’s 2019 letter “carrie[d] the
`force of law necessary to have preemptive effect.” Id.
`at 16a. The court likewise rejected petitioner’s implied-
`preemption argument, holding that petitioner had not
`established that compliance with both federal and state
`labeling requirements was impossible. Id. at 19a-22a.
`b. The court of appeals rejected petitioner’s chal-
`lenge to the admission of respondent’s expert medical
`testimony. The court explained that the district court
`had “applied the correct legal standard under [Daubert
`v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579
`(1993),] and did not abuse its discretion by admitting
`
`
`
`

`

`6
`
`[respondent’s] general and specific causation expert
`testimony.” Pet. App. 22a.
`DISCUSSION
`The court of appeals correctly held that FIFRA does
`not preempt respondent’s claims, and that decision does
`not conflict with any decision of this Court or another
`court of appeals. The court’s evidentiary ruling likewise
`does not conflict with the standards applied by other
`circuits in considering the admissibility of expert testi-
`mony. The petition for a writ of certiorari should be de-
`nied.
`In the court of appeals, the United States filed an
`amicus brief that (a) took the position that FIFRA ex-
`pressly preempts all health-related state pesticide la-
`beling requirements that differ from the labeling ap-
`proved by EPA and (b) briefly suggested that FIFRA
`also impliedly preempted respondent’s claims. Gov’t
`C.A. Amicus Br. 13-14, 18 n.14, 23-24. In light of the
`court of appeals’ decision and the change in Administra-
`tion, the United States has reexamined the arguments
`it made below. Although some aspects of EPA-
`approved labeling may preempt particular state-law re-
`quirements, EPA’s approval of labeling that does not
`warn about particular chronic risks does not by itself
`preempt a state-law requirement to provide such warn-
`ings.
`I. THE PREEMPTION QUESTION DOES NOT WARRANT
`REVIEW
`
`A. The Court Of Appeals Correctly Held That FIFRA Does
`Not Preempt Respondent’s State-Law Failure-To-Warn
`Claims
`Petitioner argues that EPA’s approval of pesticide
`labeling without a chronic-risk warning triggers FIFRA’s
`
`
`
`

`

`7
`
`express-preemption provision, 7 U.S.C. 136v(b), and
`categorically preempts any state-law requirement to
`provide such a warning. That is incorrect. Petitioner
`likewise has not established that FIFRA impliedly
`preempts respondent’s claims.
`1. FIFRA does not expressly preempt respondent’s
`state-law failure-to-warn claims
`a. In Bates v. Dow Agrosciences LLC, 544 U.S. 431
`(2005), this Court characterized Section 136v(b)’s
`preemptive effect as “narrow, but still important.” Id.
`at 452. The Court explained that, “[f ]or a particular
`state rule to be pre-empted, it must satisfy two condi-
`tions”: “[I]t must be a requirement ‘for labeling or
`packaging,’ ” and it must impose a labeling or packaging
`is “ ‘in addition to or different
`requirement that
`from those required under [FIFRA].’ ” Id. at 444; see
`7 U.S.C. 136v(b). The Court held that common-law tort
`rules that subject manufacturers to potential failure-to-
`warn liability are “requirements for labeling or packag-
`ing” under Section 136v(b). Bates, 544 U.S. at 446. It
`further held, however, that such a “state-law labeling
`requirement is not pre-empted by § 136v(b) if it is
`equivalent to, and fully consistent with, FIFRA’s mis-
`branding provisions.” Id. at 447.
`In so holding, the Bates Court emphasized that
`FIFRA “authorizes a relatively decentralized scheme
`that preserves a broad role for state regulation.” 544
`U.S. at 450. While acknowledging that it would be un-
`workable to have “50 different labeling regimes pre-
`scribing the color, font size, and wording of warnings,”
`the Court construed FIFRA as expressly preempting
`only those state laws that “would impose a labeling re-
`quirement that diverges from those set out in FIFRA
`and its implementing regulations.” Id. at 452.
`
`
`

`

`8
`
`b. The court of appeals held that California common
`law parallels FIFRA’s misbranding prohibition: Cali-
`fornia requires a warning against a known or knowable
`risk, while FIFRA requires a warning “necessary” and
`“adequate to protect health.” Pet. App. 13a (quoting
`7 U.S.C. 136(q)(1)(G)). Petitioner has not disputed, in
`this Court or the court of appeals, that California law is
`“fully consistent” with the statutory misbranding pro-
`hibition. Bates, 544 U.S. at 447. Likewise, petitioner
`does not identify any EPA regulation that “refine[s]”
`FIFRA’s misbranding standard, id. at 453 n.27, in a way
`that bears on the preemption question here.
`Instead, petitioner principally asserts that EPA’s reg-
`istration of a specific pesticide and approval of its pro-
`posed labeling creates a more particularized FIFRA la-
`beling “requirement” that categorically preempts any
`State from requiring additional warnings. Pet. 13-14. Ac-
`cordingly, petitioner argues, EPA’s registration of
`Roundup without a cancer warning on the labeling
`preempts any imposition of state-law tort liability for fail-
`ure to provide such a warning. Ibid. The court of appeals
`correctly rejected that argument. Pet. App. 14a-16a.
`FIFRA states that registration is not a “defense for
`the commission of any offense” under FIFRA, but is
`simply “prima facie evidence that the pesticide, its label-
`ing[,] and packaging comply with the registration provi-
`sions” of FIFRA. 7 U.S.C. 136a(f )(2). The Act thus makes
`clear that a particular pesticide may be found to violate
`FIFRA’s misbranding prohibition even though EPA ap-
`proved the labeling when registering the pesticide. See
`Pet. App. 14a-15a. Section 136a(f )(2) does not directly ad-
`dress preemption of state law. But the fact that “EPA’s
`labeling determinations are not dispositive of FIFRA
`compliance” supports the court of appeals’ conclusion
`
`
`

`

`9
`
`that, for purposes of preemption under Section 136v(b),
`those determinations “similarly are not conclusive as to
`which common law requirements are ‘in addition to or dif-
`ferent from’ the requirements imposed by FIFRA.” Id.
`at 15a (quoting 7 U.S.C. 136v(b)).
`Petitioner contends that the court of appeals “assessed
`FIFRA’s requirements at too high a level of generality,”
`Pet. 14, by declining to treat specific EPA pesticide-
`registration approvals as establishing particularized
`FIFRA “requirements” under Section 136v(b). But the
`court’s approach is faithful to Bates. In remanding the
`case for further proceedings in the lower courts, the Bates
`Court “emphasize[d] that a state-law labeling require-
`ment must in fact be equivalent to a requirement under
`FIFRA in order to survive pre-emption.” 544 U.S. at 453.
`The Court indicated, however, that in determining
`whether this equivalence existed, the lower courts should
`compare the generally applicable state-law standard to
`the requirements imposed by FIFRA and by EPA’s im-
`plementing regulations. Id. at 453-454. And while the
`Court recognized that “a manufacturer should not be held
`liable under a state labeling requirement * * * unless the
`manufacturer is also liable for misbranding as defined by
`FIFRA,” id. at 454, it did not suggest that EPA’s prior
`approval of the manufacturer’s labeling would preclude a
`state-law plaintiff from making that showing. To the con-
`trary, the Bates Court allowed the suit before it to go for-
`ward even though the plaintiffs’ claim was premised on
`the defendant’s failure to provide cautionary language
`that did not appear on the EPA-approved label. See id. at
`
`
`
`

`

`10
`
`434-435. That disposition would be inexplicable under pe-
`titioner’s view of the statute.1
`That does not mean that EPA registration and label-
`ing decisions are never preemptive. FIFRA and EPA
`regulations identify aspects of EPA-approved pesticide
`labeling that carry the force of law. For example,
`FIFRA and its implementing regulations make “use”
`requirements on EPA-approved labeling mandatory
`and enforceable against the user. See 7 U.S.C.
`136j(a)(2)(G) (“[I]t shall be unlawful for any person
`* * * to use any registered pesticide in a manner incon-
`sistent with its labeling.”); 40 C.F.R. 156.10(i)(2)(ii) (“It
`is a violation of Federal law to use this product in a man-
`ner inconsistent with its labeling.”). These enforceable
`“use” restrictions may operate as FIFRA “require-
`ments” with preemptive effect, generally barring States
`from permitting uses that EPA-approved labeling pro-
`hibits. See Bates, 544 U.S. at 453 (“State-law require-
`ments must also be measured against any relevant EPA
`regulations.”).
`Neither FIFRA nor its implementing regulations,
`however, specifically address warnings for chronic health
`risks like carcinogenicity. No FIFRA provision or EPA
`
`1 Petitioner suggests that the Court’s analysis in Bates was lim-
`ited to claims about a pesticide’s eff icacy, because EPA does not re-
`view efficacy claims in the registration process. Pet. Reply Br. 4-5.
`But the Bates Court did not suggest that the preemption test it ar-
`ticulated was limited in this manner. The Court discussed the ap-
`plication of its preemption test to a hypothetical “failure-to-warn
`claim alleging that a given pesticide’s label should have stated
`‘DANGER’ instead of the more subdued ‘CAUTION.’ ” Bates, 544
`U.S. at 453. The Court found that such a claim “would be pre-
`empted,” not because it concerned safety rather than efficacy warn-
`ings, but “because it is inconsistent with” a specific EPA regulation.
`Ibid.; see pp. 17-18, infra.
`
`
`
`

`

`11
`
`regulation either requires or precludes warnings about
`harm a pesticide may cause to human health through
`long-term exposure. And EPA does not typically use the
`registration process to address those harms by requiring
`chronic-risk warnings on a pesticide’s labeling. Rather,
`EPA primarily seeks to control such risks through use
`limitations or, where appropriate, cancellation proceed-
`ings.2
`EPA regulations likewise do not purport to define the
`full universe of labeling that might be necessary and ade-
`quate “to protect health and the environment.” 7 U.S.C.
`136(q)(1)(G). EPA guidance allows a manufacturer to pro-
`pose state-mandated chronic-risk warnings, such as Prop-
`osition 65 warnings, so long as the state-law terminology
`does not conflict with language in the EPA-approved la-
`bel. See EPA, Label Review Manual, Ch. 7, § IV.A.4, at
`7-4 (rev. Mar. 2018), https://www.epa.gov/pesticide-
`registration/label-review-manual; see also, e.g., id. Ch. 3
`§ V.B, at 3-14 (allowing registrants to include “[a]dvisory
`statements” about “product characteristics and how to
`maximize safety and efficacy,” so long as such statements
`“do not conflict with mandatory statements, are not false
`or misleading, and do not otherwise violate statutory or
`regulatory requirements”).
` Against that backdrop,
`EPA’s approval of pesticide labeling without a chronic-
`risk warning is not naturally characterized as a FIFRA
`“requirement” that no such warning appear. See Bates,
`544 U.S. at 445 (explaining, with specific reference to Sec-
`tion 136v(b)’s preemptive scope, that “[a] requirement is
`
`
`2 By contrast, EPA regulations specif ically address warnings
`about how products should be handled to avoid acute, rather than
`chronic, hazards to human health. See 40 C.F.R. 156.70(b),
`158.130(d)(1).
`
`
`
`

`

`12
`
`a rule of law that must be obeyed”); see also id. at 449
`(noting “[t]he long history of tort litigation against manu-
`facturers of poisonous substances,” and declining to con-
`strue Section 136v(b) as “depriv[ing] injured parties of a
`long available form of compensation”).3
`c. Petitioner also contends that respondent’s claims
`are preempted even if EPA’s approval of pesticide label-
`ing does not categorically preempt all state-law tort
`claims that are premised on the alleged inadequacy of a
`manufacturer’s label-compliant warnings. Petitioner em-
`phasizes (i) EPA’s longstanding view that glyphosate is
`not carcinogenic; and (ii) the 2019 letter in which the Di-
`rector of the Registration Division of EPA’s Office of Pes-
`ticide Programs stated that a pesticide would be mis-
`branded if its labeling included a Proposition 65 warning
`that linked glyphosate to cancer risks. Pet. 13-14. Nei-
`ther contention alters the preemption analysis.
`EPA has long concluded that glyphosate is not likely
`to be carcinogenic to humans and has repeatedly articu-
`lated that view in registration decisions spanning decades.
`Pet. App. 4a. But inconsistency between state and federal
`risk assessments does not alone preempt enforcement of
`state tort law. Rather, Section 136v(b) preempts only
`those state-law “requirements for labeling or packaging”
`
`
`3 EPA’s registration of a particular pesticide is reviewed every 15
`years, based in signif icant part on proposed labeling and scientif ic
`studies submitted by the manufacturer. See pp. 1-2, supra.
`Through that periodic-review process, EPA reassesses the risks
`and benefits of particular pesticides under the “unreasonable ad-
`verse effect” standard, 7 U.S.C. 136(bb). Petitioner’s preemption
`theory ignores the possibility that the manufacturer’s submissions
`to EPA may be inaccurate or incomplete, or that evolving science
`will cast doubt on the adequacy of approved labeling before the next
`periodic review occurs.
`
`
`
`

`

`13
`
`that are “in addition to or different from those required
`under [FIFRA].” 7 U.S.C. 136v(b) (emphasis added). As
`the court of appeals appeared to recognize, EPA could—
`either through rulemaking or through some other regula-
`tory action carrying the force of law—make a binding de-
`termination that the labels of pesticides containing
`glyphosate should not contain cancer warnings. See Pet.
`App. 15a. Such a determination would preempt any state-
`law tort claim premised on a manufacturer’s failure to
`provide such warnings. But neither EPA’s repeated
`statements that glyphosate is unlikely to be carcinogenic
`to humans, nor its approval of pesticide labeling without
`cancer warnings, imposes any such prohibition. See ibid.4
`The 2019 letter issued by the Director of the Registra-
`tion Division likewise does not change the preemption cal-
`culus. No FIFRA provision or EPA regulation authorizes
`that agency official to impose binding FIFRA “require-
`ments” on manufacturers through an informal letter. And
`even if that letter could have preemptive effect, it focused
`solely on the default language required by Proposition 65
`and did not address other potential label language that
`might accommodate both federal and state views. Pet.
`
`
`4 Petitioner emphasizes (Pet. 13) EPA’s 2020 Glyphosate: Interim
`Registration Review Decision, Case Number 0178 (Jan. 22, 2020)
`(Interim Registration Review Decision), https://www.epa.gov/
`sites/default/files/2020-01/documents/glyphosate-interim-reg-review-
`decision-case-num-0178.pdf, which followed a notice-and-comment
`process and again concluded that glyphosate presents no “risks of
`concern.” Id. at 9. But while that notice-and-comment process
`could have culminated in binding requirements or prohibitions gov-
`erning chronic-hazard warnings for glyphosate, it did not. In any
`event, EPA’s 2020 Interim Registration Review Decision post-
`dated the decision below and—by many years—respondent’s use of
`Roundup, this lawsuit, and the jury’s verdict.
`
`
`

`

`14
`
`App. 197a. Indeed, EPA has recently issued a letter iden-
`tifying a proposed glyphosate warning that would not be
`considered false or misleading and that EPA could ap-
`prove if requested for inclusion on glyphosate product la-
`bels. See Letter from Michal Freedhoff, Assistant Adm’r,
`Office of Chem. Safety & Pollution Prevention, EPA, to
`Lauren Zeise, Dir., Office of Envtl. Health Hazard As-
`sessment, Cal. Envtl. Prot. Agency (Apr. 8, 2022),
`https://oehha.ca.gov/media/downloads/crnr/usepaaafreed-
`hofftooehhadirzeiseglyphosate40822.pdf. In addition, the
`2019 letter postdated the jury verdict here by more than
`four months and respondent’s last use of Roundup by sev-
`eral years, and it was logically inconsistent with prior
`EPA approvals of manufacturer requests to include can-
`cer warnings on the labels of their glyphosate-containing
`products. See p. 4, supra. If the Court granted certiorari,
`it therefore might be required to decide difficult retroac-
`tivity issues in order to assess the implications of the 2019
`letter for the preemption analysis, particularly in light of
`the clarification in the 2022 letter.
`2. FIFRA does not impliedly preempt respondent’s
`state-law claims
` Federal law impliedly preempts state law when “it is
`impossible for a private party to comply with both state
`and federal law” or when state law “ ‘stands as an obsta-
`cle to the accomplishment and execution of the full pur-
`poses and objectives of Congress.’ ” Crosby v. National
`Foreign Trade Council, 530 U.S. 363, 372-373 (2000) (ci-
`tation omitted). In support of its implied-preemption
`theory, petitioner argues solely that compliance with
`both federal and California law would have been impos-
`sible. See Pet. 20-24. To establish this “demanding de-
`fense,” a party must present “clear evidence” of
`
`
`
`

`

`15
`
`impossibility, Wyeth v. Levine, 555 U.S. 555, 571, 573
`(2009); the “possibility of
`impossibility
`[is] not
`enough,” PLIVA, Inc. v. Mensing, 564 U.S. 604, 62

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