No. 21-241
`
`In the
`Supreme Court of the United States
`
`MONSANTO COMPANY,
`
`v.
`
`EDWIN HARDEMAN,
`
`Petitioner,
`
`Respondent.
`
`On PetitiOn fOr a Writ Of CertiOrari tO the United
`StateS COUrt Of aPPealS fOr the ninth CirCUit
`
`BRIEF OF CROPLIFE AMERICA AS AMICUS
`CURIAE IN SUPPORT OF PETITIONER
`MONSANTO COMPANY
`
`Shannen W. CoffIn
`Counsel of Record
`Sara Beth WatSon
`Mark C. SavIgnaC
`Steptoe & JohnSon LLp
`1330 Connecticut Avenue, NW
`Washington, D.C. 20036
`(202) 429-3000
`scoffin@steptoe.com
`
`Counsel for Amicus Curiae
`
`
`
`In the
`Supreme Court of the United States
`
`MONSANTO COMPANY,
`
`v.
`
`EDWIN HARDEMAN,
`
`Petitioner,
`
`Respondent.
`
`On PetitiOn fOr a Writ Of CertiOrari tO the United
`StateS COUrt Of aPPealS fOr the ninth CirCUit
`
`BRIEF OF CROPLIFE AMERICA AS AMICUS
`CURIAE IN SUPPORT OF PETITIONER
`MONSANTO COMPANY
`
`Shannen W. CoffIn
`Counsel of Record
`Sara Beth WatSon
`Mark C. SavIgnaC
`Steptoe & JohnSon LLp
`1330 Connecticut Avenue, NW
`Washington, D.C. 20036
`(202) 429-3000
`scoffin@steptoe.com
`
`Counsel for Amicus Curiae
`
`
`
`TABLE OF CONTENTS
`
`INTEREST OF AMICUS CURIAE ............................. 1
`
`INTRODUCTION AND SUMMARY OF ARGUMENT
` ........................................................................... 3
`
`BACKGROUND .......................................................... 6
`
`A.
`
`B.
`
`C.
`
`FIFRA Registration ............................... 6
`
`FIFRA Labeling Requirements ............. 7
`
`FIFRA Bars States From Imposing
`Different Labeling Requirements ......... 9
`
`ARGUMENT ............................................................... 9
`
`I.
`
`FIFRA EXPRESSLY PREEMPTS ANY STATE-LAW
`REQUIREMENT
`THAT
`GLYPHOSATE-BASED
`PESTICIDES BEAR A CANCER WARNING ........... 10
`
`A.
`
`B.
`
`Plaintiff’s Duty-to-Warn Claim Imposes
`a State Requirement Different from and
`in Addition to FIFRA ........................... 10
`
`The Ninth Circuit Erred By Placing
`Undue Weight on 7 U.S.C. § 136a(f)(2)
` .............................................................. 19
`
`II.
`
`FIFRA IMPLIEDLY PREEMPTS ANY STATE-LAW
`REQUIREMENT
`GLYPHOSATE-BASED
`THAT
`PESTICIDES BEAR A CANCER WARNING ........... 21
`
`III. THE PETITION PRESENTS AN EXCEPTIONALLY
`IMPORTANT PREEMPTION QUESTION ................ 24
`
`CONCLUSION .......................................................... 27
`
`
`
`
`
`
`
`
`
`ii
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`
`
`
`Cases
`
`Bates v. Dow Agrosciences LLC,
`544 U.S. 431 (2005) ...................................... passim
`
`MacDonald v. Monsanto Co.,
`27 F.3d 1021 (5th Cir. 1994) ............................ 5, 20
`
`Merck Sharp & Dohme Corp. v. Albrecht,
`139 S. Ct. 1668 (2019) .......................... 4, 22, 23, 24
`
`National Association of Wheat Growers v.
`Becerra,
`468 F. Supp. 3d 1247 (E.D. Cal. 2020) ................ 14
`
`NRDC v. EPA,
`Nos. 20-70787, 20-70801 (9th Cir. May
`18, 2021) ......................................................... 15, 16
`
`PLIVA, Inc. v. Mensing,
`564 U.S. 604 (2011) .............................................. 23
`
`Ruckelshaus v. Monsanto Co.,
`467 U.S. 987 (1984) ................................................ 6
`
`Smiley v. Citibank (South Dakota), N.A.,
`517 U.S. 735 (1996) .............................................. 16
`
`United States v. Mead Corp.,
`533 U.S. 218 (2001) .................................. 16, 17, 19
`
`
`
`iii
`
`
`Wyeth v. Levine,
`555 U.S. 555 (2009) ........................................ 22, 23
`
`Statutes
`
`7 U.S.C. § 136 ............................................ 1, 6, 7, 9, 18
`
`7 U.S.C. § 136a ....................................... 6, 7, 18, 19 24
`
`7 U.S.C. § 136j ............................................................. 9
`
`7 U.S.C. § 136v ...................................................... 4, 10
`
`FIFRA Regulations
`
`40 C.F.R. § 152.44 ....................................................... 9
`
`40 C.F.R. § 152.112 ..................................................... 9
`
`40 C.F.R. § 155.40 ....................................................... 7
`
`40 C.F.R. § 155.50 ....................................................... 7
`
`40 C.F.R. § 156.10 .............................................. 8,9, 18
`
`40 C.F.R. § 156.60 ....................................................... 8
`
`40 C.F.R. § 156.70 ............................................. 8, 9, 18
`
`40 C.F.R. § 158.500 ..................................................... 6
`
`EPA Materials
`
`Final Rule: Glyphosate; Pesticide
`Tolerances, 62 Fed. Reg. 17,723
`(Apr. 11, 1997) ...................................................... 12
`
`
`
`iv
`
`
`Final Rule: Glyphosate; Pesticide
`Tolerances, 67 Fed. Reg. 60,934
`(Sept. 27, 2002) .................................................... 12
`
`Final Rule: Glyphosate; Pesticide
`Tolerances, 73 Fed. Reg. 73,586
`(Dec. 3, 2008) ........................................................ 12
`
`EPA, Glyphosate: Draft Human Health
`Risk Assessment in Support of
`Registration Review, Case No. 0178
`(Dec. 12, 2017),
`www.regulations.gov/document/EPA-
`HQ-OPP-2009-0361-0068 .................................... 13
`
`EPA, Glyphosate: Interim Registration
`Review Decision, Case No. 0178
`(Jan. 2020),
`www.epa.gov/sites/production/files/2020-
`01/documents/glyphosate-interim-reg-
`review-decision-case-num-0178.pdf .............. 15, 17
`
`EPA, Glyphosate: Proposed Interim
`Registration Review Decision, Case No.
`0178 (Apr. 2019),
`www.regulations.gov/document?D=EPA-
`HQ-OPP-2009-0361-2344 ........................ 13, 14, 26
`
`EPA, Ingredients Used in Pesticide
`Products: Glyphosate,
`www.epa.gov/ingredients-used-pesticide-
`products/glyphosate ............................................. 11
`
`
`
`v
`
`
`EPA, Letter to Glyphosate Registrants on
`California Proposition 65 (Aug. 7, 2019),
`www.epa.gov/sites/production/files/2019-
`08/documents/glyphosate_registrant_lett
`er_-_8-7-19_-_signed.pdf ............................ 4, 14, 15
`
`EPA, Office of Pesticide Programs, Label
`Review Manual,
`www.epa.gov/sites/production/files/2021-
`02/documents/full-lrm_2-22-21.pdf ....................... 8
`
`EPA, Office of Pesticide Programs, Revised
`Glyphosate Issue Paper: Evaluation of
`Carcinogenic Potential (Dec. 12, 2017),
`usrtk.org/wp-
`content/uploads/2019/04/REVISED_GLY
`PHOSATE_ISSUE_
`PAPER_EVALUATION_OF_CARCINO
`GENIC_POTENTIAL-1.pd ............................ 12, 13
`
`EPA Pesticide Registration Notice (PRN)
`2000-5: Guidance for Mandatory and
`Advisory Labeling Statements (May 10,
`2000), www.epa.gov/pesticide-
`registration/prn-2000-5-guidance-
`mandatory-and-advisory-labeling-
`statements ........................................................ 9, 25
`
`EPA, R.E.D. Facts, Glyphosate (Sept. 1993),
`archive.epa.gov/pesticides/reregistration/
`web/pdf/0178fact.pdf ............................................ 12
`
`EPA, Reregistration Eligibility Decision
`(RED): Glyphosate (Sept. 1993) .......................... 11
`
`
`
`
`
`
`International Regulatory Materials
`
`vi
`
`European Chemicals Agency, Glyphosate
`Not Classified as a Carcinogen by ECHA
`(Mar. 15, 2017), echa.europa.eu/-
`/glyphosate-not-classified-as-a-
`carcinogen-by-echa ............................................... 14
`
`European Food Safety Authority,
`Glyphosate: EFSA Updates Toxicological
`Profile (Nov. 12, 2015),
`www.efsa.europa.eu/en/press/news/1511
`12 .......................................................................... 14
`
`Federal Institute for Risk Assessment (BfR,
`Germany), BfR Comm’cn No. 007/2015,
`Does Glyphosate Cause Cancer,
`www.bfr.bund.de/cm/349/does-
`glyphosate-cause-cancer.pdf ................................ 14
`
`Miscellaneous
`
`Bayer, “Bayer announces agreements to
`resolve major legacy Monsanto
`litigation” (June 24, 2020),
`media.bayer.com/baynews/baynews.nsf/i
`d/Bayer-announces-agreements-to-
`resolve-major-legacy-Monsanto-litigation .......... 25
`
`
`
`vii
`
`
`Phillips McDougal, “The Cost of New
`Agrochemical Product Discovery,
`Development and Registration in 1995,
`2000, 2005-8 and 2010-2014,” A
`Consultancy Study for CropLife
`International, CropLife America and the
`European Crop Protection Association 3-
`4 (March 2016), croplife.org/wp-
`content/uploads/2016/04/Cost-of-CP-
`report-FINAL.pdf ................................................... 2
`
`
`
`
`
`INTEREST OF AMICUS CURIAE1
`
`CropLife America, established in 1933, is the
`national trade association for the plant science
`industry, representing developers, manufacturers,
`formulators, and distributors of crop protection
`chemicals and plant science solutions for agriculture
`and pest management. CropLife America’s member
`companies produce, sell, and distribute crop
`protection
`products,
`including
`herbicides,
`insecticides, and fungicides, which farmers use to
`provide consumers with abundant food and fiber.
`CropLife America
`is committed
`to safe and
`responsible use of the industry’s products.
`
`CropLife America’s members are deeply invested
`in the discovery and development of new crop
`protection products and product uses. They are
`intimately
`familiar with
`the
`comprehensive
`regulation of pesticides under the Federal Insecticide,
`Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C.
`§ 136 et seq. When the Environmental Protection
`Agency (“EPA”) makes a registration decision, it does
`so based on a thorough review of current scientific and
`technical information provided at significant cost to
`manufacturers.
` CropLife America’s member
`
`
`1 CropLife America provided timely notice of its intention to
`file this brief to the parties, who consented in writing to the
`filing. No counsel for either party authored this brief in whole or
`in part, nor did any party or other person or entity other than
`amicus curiae, its members, and its counsel make a monetary
`contribution intended to fund its preparation or submission.
`Petitioner Monsanto Company’s parent company, Bayer Corp., is
`a member of CropLife America, but apart from the dues it pays
`as a member, did not contribute money intended to fund
`preparation or submission of this brief.
`
`
`
` 2
`
`
`
`
`
`companies spend, on average, $286 million and 11.3
`years on research, development, and registration of
`crop protection products that reach the marketplace.2
`These registration costs have increased in recent
`years, largely due to increased environmental safety
`and toxicology data required by regulators.
`
`CropLife America’s member companies urge the
`Court to grant the Petition. Our member companies
`have a keen interest in FIFRA’s legal framework,
`especially the interrelationship between federal and
`state pesticide regulation.
` Member companies
`manufacture and distribute products containing
`glyphosate—the most widely used herbicide in the
`world.
`
`The preemption issues addressed in the Petition
`reach well beyond this particular case. This case was
`selected as a bellwether, and the decision here affects
`CropLife America member companies’ liability in
`literally thousands of pending cases. The Court of
`Appeals’ FIFRA preemption holdings have the
`potential to affect countless other products regulated
`under FIFRA.
`
`The fundamental question here is whether EPA’s
`determination that glyphosate product labels should
`not contain a cancer warning—based on EPA’s
`repeated expert determination that glyphosate does
`not cause cancer—can be overridden by lay juries
`
`
`2 See Phillips McDougal, “The Cost of New Agrochemical
`Product Discovery, Development and Registration in 1995, 2000,
`2005-8 and 2010-2014,” A Consultancy Study for CropLife
`International, CropLife America and the European Crop
`Protection Association 3-4
`(March 2016), croplife.org/wp-
`content/uploads/2016/04/Cost-of-CP-report-FINAL.pdf.
`
`
`
` 3
`
`
`
`
`
`under state law. The Ninth Circuit erroneously held
`that FIFRA does not preempt California state failure-
`to-warn tort claims. Because the implications of that
`decision are so far reaching and its conclusion so
`gravely wrong, this Court should grant the Petition to
`review the judgment below.
`
`INTRODUCTION AND
`SUMMARY OF ARGUMENT
`
`This Court should grant the petition to address
`important questions of federal preemption that the
`Court of Appeals erroneously decided, to resolve a
`conflict of law among the lower courts, and to
`harmonize a body of preemption law that lower courts
`have struggled to apply with any consistency.
`
`The decision below is manifestly wrong on an issue
`of substantial public importance. EPA, the expert
`federal agency charged by Congress with evaluating
`pesticide safety under FIFRA, has repeatedly and
`emphatically
`declared
`that
`glyphosate-based
`pesticides do not cause cancer. Thus, no such
`warnings are permitted on the product label. Yet the
`decision below upheld a massive
`jury verdict,
`complete with punitive damages, on a state-law claim
`that Monsanto violated California law by selling
`glyphosate-based pesticides without the very warning
`that EPA found unnecessary and unsupported. That
`decision was contrary to this Court’s precedents:
`Because Plaintiff’s failure-to-warn claim directly
`contradicts EPA’s authoritative pronouncements in
`the exercise of its labeling authority under FIFRA, it
`is preempted.
`
`
`
` 4
`
`
`
`
`
`First, plaintiff’s California failure-to-warn claims
`are expressly preempted by FIFRA’s command that
`states “shall not impose or continue in effect any
`requirements for labeling or packaging in addition to
`or different from those required under” that statute.
`7 U.S.C. § 136v(b). In light of EPA’s repeated
`determinations that glyphosate-based pesticides do
`not cause cancer, federal law does not require that
`such pesticides carry a cancer warning. Yet the
`premise of the verdict here is that California law
`requires that same warning. Such a different state
`law requirement is expressly preempted.
`
`Second, the verdict is impliedly preempted because
`it is “impossible for a private party to comply with
`both state and federal requirements.” Merck Sharp &
`Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1672 (2019).
`FIFRA prohibits a pesticide’s sale unless it bears an
`EPA-approved label. EPA may approve a label only if
`it concludes that the label’s statements are not false
`or misleading. Having repeatedly determined that
`glyphosate-based pesticides do not pose a cancer risk,
`EPA necessarily deems a warning that they do pose
`such a risk to be false and misleading. EPA therefore
`could not approve a label bearing such a warning and
`has explicitly stated as much.3 Nor could a pesticide
`manufacturer unilaterally add a cancer warning to
`the label. Because it would be impossible for a
`manufacturer to comply with its federal-law duty not
`to include a cancer warning on the label while also
`
`3 EPA, Letter to Glyphosate Registrants on California
`Proposition 65, at 1
`(Aug. 7, 2019)
`(“EPA Letter”),
`www.epa.gov/sites/production/files/2019-
`08/documents/glyphosate_registrant_letter_-_8-7-19_-
`_signed.pdf.
`
`
`
` 5
`
`
`
`
`
`complying with the state-law duty to warn, any such
`state-law duty is preempted.
`
`The Ninth Circuit recognized that EPA’s cancer
`determinations would normally have the force of law,
`but concluded that 7 U.S.C. § 136a(f)(2) deprives them
`of that force. That conclusion conflicts with the Fifth
`Circuit’s recognition that § 136a(f)(2) “has no bearing”
`on federal preemption. MacDonald v. Monsanto Co.,
`27 F.3d 1021, 1027 n.4 (5th Cir. 1994).
`
`In any event, § 136(f)(2) does not control here.
`That provision reflects the fact that EPA may not
`review every labeling claim a manufacturer makes
`during product registration.
` In Bates v. Dow
`Agrosciences LLC, this Court remanded state-law
`claims based on the efficacy of a pesticide, while
`raising doubts that such claims would be preempted
`by EPA’s registration decision, where EPA had waived
`efficacy review and not passed on those claims at all.
`544 U.S. 431, 440 (2005). But where, as here, EPA
`has applied its scientific expertise to the most current
`evidence to make a more granular determination that
`glyphosate does not cause cancer, that determination
`is binding on the States.
`
`Finally, the preemption issues here are both
`legally and socially important. Monsanto alone faces
`tens of thousands of claims like this one, with more
`than 5,000 cases currently pending in federal court.
`The Ninth Circuit’s decision will cause significant
`confusion for manufacturers, who now face the
`uncertainty
`of
`competing—and
`diametrically
`opposed—state and
`federal
`label requirements.
`Moreover,
`permitting
`lay
`juries
`to
`force
`manufacturers to add false cancer warnings to
`
`
`
` 6
`
`
`
`
`
`glyphosate-based pesticides would do immeasurable
`harm, including by threatening to force products that
`EPA has deemed safe and economically vital off the
`market. There is a real-world cost, in both economic
`and public health terms, to “crying wolf.”
`
`This Court should grant certiorari.
`
`BACKGROUND
`
`FIFRA is a “comprehensive regulatory statute”
`(Ruckelshaus v. Monsanto Co., 467 U.S. 987, 991
`(1984)), governing the sale, use, and labeling of
`“pesticides.” FIFRA’s definition of “pesticide” includes
`“any substance or mixture of substances intended for
`use as a plant regulator, defoliant, or desiccant,” 7
`U.S.C. § 136(u), and thus encompasses glyphosate-
`based herbicides like Monsanto’s Roundup products.
`
`A. FIFRA Registration
`
`FIFRA prohibits the sale of “any pesticide that is
`not registered.” 7 U.S.C. § 136a(a). FIFRA and its
`implementing regulations require registrants to
`provide substantial scientific data to support a
`pesticide’s safety and health effects, including studies
`relating to the likelihood that a particular pesticide
`could cause cancer. 7 U.S.C. §§ 136a(c)(1)(F) &
`(c)(2)(A); 40 C.F.R. § 158.500(d); see generally 40
`C.F.R. pt. 158.
`
`it
`if
`EPA “shall register a pesticide” only
`determines
`that,
`“when considered with any
`restrictions imposed,” the pesticide meets four general
`requirements: 1) its composition is such as to warrant
`the proposed claims for it; 2) its labeling complies with
`FIFRA’s requirements; 3) it will perform its intended
`function without unreasonable adverse effects on the
`
`
`
` 7
`
`
`
`
`
`environment; and 4) 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).
`
`FIFRA defines “unreasonable adverse effects on
`the environment” to mean “any unreasonable risk to
`man or the environment,” a calculus that requires
`EPA
`to balance
`the
`“economic, social, and
`environmental costs and benefits of the use of any
`pesticide.”
` Id. § 136(bb).
` It also
`includes
`consideration of any “human dietary risk from
`residues that result from a use of a pesticide” on food
`inconsistent with Food, Drug & Cosmetic Act
`standards. See id. FIFRA allows EPA to waive data
`requirements pertaining to—and register a pesticide
`without
`reviewing—product
`efficacy.
`
`Id.
`§ 136a(c)(5)(D); see Bates, 544 U.S. at 440. EPA
`cannot similarly waive review for adverse human
`health and environmental effects; it must conduct this
`searching review, including toxicology review, in
`every registration.
`
`Congress requires EPA to reevaluate a pesticide at
`least once every 15 years to determine whether it
`continues to satisfy FIFRA’s registration standards.
`See 7 U.S.C. § 136a(g); 40 C.F.R. § 155.40 et seq. This
`process involves a review of the applicable science
`under public notice and comment procedures. See 40
`C.F.R. § 155.50.
`
`B. FIFRA Labeling Requirements
`
`focus of EPA’s registration and
`A central
`registration review is the product’s label. “Pesticide
`product labels provide critical information about how
`
`
`
` 8
`
`
`
`
`
`to safely and legally handle and apply pesticides.”4 A
`“critical function of the label is to translate the results
`of the science evaluations into a set of conditions,
`directions, precautions, and restrictions that define
`who may use a pesticide, as well as where, how, how
`much, and how often it may be used.”5
`
`EPA’s Label Review Manual notes that the
`accuracy of the label is “vital” to EPA’s (and other
`agencies’) management and mitigation of pesticide
`risks; to these agencies’ enforcement of pesticide
`production, distribution, and use requirements; to
`registrants,
`including
`manufacturers
`and
`distributors; to applicators, who rely on the label for
`use instructions and hazard and safety information;
`and to the general public.6
`
`FIFRA’s regulations provide that a product label
`must include any “pertinent information which the
`[EPA] Administrator determines to be necessary for
`the protection of man and the environment.” 40
`C.F.R. § 156.10(i)(2)(x)(F); see also id. § 156.70(b). A
`product label “is required to bear hazard and
`precautionary statements for humans and domestic
`animals.” Id. § 156.60. Any “[s]pecific statements
`pertaining to the hazards of the product and its uses
`must be approved by [EPA].” Id. § 156.70(c).
`
`It is unlawful to distribute or sell any misbranded
`pesticide. 7 U.S.C. § 136j(a)(1)(E). EPA will not
`
`
`4 EPA, Office of Pesticide Programs, Label Review Manual at
`1-2, www.epa.gov/sites/production/files/2021-02/documents/full-
`lrm_2-22-21.pdf.
`5 Id.
`6 Id.
`
`
`
` 9
`
`
`
`
`
`register a pesticide unless it “has determined that the
`product is not misbranded . . . and its labeling and
`packaging comply with the applicable requirements”
`of FIFRA and its regulations. 40 C.F.R. § 152.112(f).
`A pesticide is misbranded if its labeling “bears any
`statement, design, or graphic representation relative
`thereto or to its ingredients which is false or
`misleading in any particular.” 7 U.S.C. § 136(q)(1)(A);
`see also 40 C.F.R. § 156.10(a)(5). A pesticide is also
`misbranded if its label “does not contain a warning or
`caution statement which may be necessary and . . . is
`adequate to protect health and the environment.” 7
`U.S.C. § 136(q)(1)(G).
`
`Once approved, a label must accompany the
`pesticide’s sale, id. § 136j(a)(2)(A), and may generally
`be amended only with EPA’s approval. 40 C.F.R.
`§ 152.44(a).7
`
`C. FIFRA Bars States From Imposing
`Different Labeling Requirements
`
`Under FIFRA’s “Uniformity” provision, 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); see also Bates, 544 U.S. at 452.
`
`ARGUMENT
`
`The Ninth Circuit decided a question of
`exceptional
`importance—both
`legally
`and
`economically—contrary to the decisions of this Court,
`
`7 See EPA Pesticide Registration Notice (PRN) 2000-5:
`Guidance for Mandatory and Advisory Labeling Statements
`(May 10, 2000), www.epa.gov/pesticide-registration/prn-2000-5-
`guidance-mandatory-and-advisory-labeling-statements.
`
`
`
`
`
`10
`
`while creating a conflict with the Fifth Circuit along
`the way.
` Two distinct doctrines of
`federal
`preemption—express preemption and impossibility
`preemption—are fatal to Plaintiff’s failure-to-warn
`claim and support granting the Petition.
`
`I. FIFRA EXPRESSLY PREEMPTS ANY STATE-LAW
`REQUIREMENT
`THAT GLYPHOSATE-BASED
`PESTICIDES BEAR A CANCER WARNING
`
`A. Plaintiff’s Duty-to-Warn Claim Imposes a
`State Requirement Different from and in
`Addition to FIFRA
`
`FIFRA expressly prohibits states from imposing
`“requirements for
`labeling . . . in addition to or
`different from those required under” FIFRA. 7 U.S.C.
`§ 136v(b). In Bates, this Court held that FIFRA “pre-
`empts any statutory or common-law rule that would
`impose a labeling requirement that diverges from
`those set out in FIFRA and its implementing
`regulations.”
` 544 U.S. at 443-44, 452.
` “[A]
`manufacturer should not be held liable under a state
`labeling requirement subject to § 136v(b) unless the
`manufacturer is also liable for misbranding as defined
`by FIFRA.” Id. at 454.
`
`The verdict below was premised on the notion that
`California common law required Monsanto to warn
`that its glyphosate-based Roundup products cause
`cancer. The question under § 136v(b) and Bates, then,
`is whether Monsanto was required to provide that
`cancer warning “under” FIFRA, making it “also liable
`for misbranding as defined by FIFRA.” Id. If not,
`Plaintiff’s state law claim is preempted.
`
`
`
`
`
`11
`
`Here, Monsanto is not “liable for misbranding as
`defined by FIFRA.” Id. EPA has repeatedly
`determined that glyphosate-based pesticides like
`Roundup do not pose a cancer risk. As a matter of
`federal law, they are not misbranded for failure to
`warn of a disease that EPA has determined they do
`not cause. Nor can a lay jury in a state-law case
`override EPA’s determination that a cancer warning
`is not required or even permitted in light of its finding
`that glyphosate-based pesticides do not cause cancer.
`That determination is supreme federal law binding
`upon the states.
`
`1. EPA has repeatedly concluded, as a matter of
`federal law, that glyphosate-based pesticides do not
`cause cancer. EPA issued its initial glyphosate
`registration in 1974 and issued a Reregistration
`Eligibility Decision
`for
`the active
`ingredient
`glyphosate, after a thorough examination of the
`underlying data, in 1993.8 In the nearly 50 years
`since the original registration, EPA has repeatedly
`concluded that glyphosate does not pose a cancer risk.
`Acting on the recommendation of a scientific peer
`review committee in the early 1990s, EPA found
`“evidence of non carcinogenicity for humans.”9 It
`
`
`in Pesticide Products:
`8 See EPA, Ingredients Used
`Glyphosate,
`www.epa.gov/ingredients-used-pesticide-
`products/glyphosate; EPA, Reregistration Eligibility Decision
`(RED): Glyphosate (Sept. 1993).
`9 See EPA, R.E.D. Facts, Glyphosate, at 2 (Sept. 1993),
`archive.epa.gov/pesticides/reregistration/web/pdf/0178fact.pdf.
`
`
`
`
`
`12
`
`reiterated that finding in a formal rule in 199710 and
`repeatedly in subsequent rulemakings.11
`
`In 2009, EPA opened its current registration
`review, which has entailed extensive review of
`glyphosate’s environmental safety and toxicology data
`after numerous rounds of public notice and comment.
`After review by both EPA’s Cancer Assessment
`Review Committee and a Scientific Advisory Panel,
`EPA published a Revised Glyphosate Issue Paper
`evaluating the pesticide’s carcinogenic potential.12
`This extensive review of “new science” included
`assessment of “63 epidemiological studies, 14 animal
`carcinogenicity studies, and nearly 90 genotoxicity
`studies for the active ingredient glyphosate.”13 EPA
`concluded that “available data and weight-of-evidence
`clearly do not support the descriptors ‘carcinogenic to
`humans’” or “‘likely to be carcinogenic to humans.’”14
`Instead, the scientific evidence most strongly supports
`the description “not likely to be carcinogenic to
`humans.”15 EPA concluded this assessment after the
`
`
`10 Final Rule: Glyphosate; Pesticide Tolerances, 62 Fed. Reg.
`17,723, 17,724 (Apr. 11, 1997).
`11 Final Rule: Glyphosate; Pesticide Tolerances, 67 Fed. Reg.
`60,934, 60,936 (Sept. 27, 2002); see also Final Rule: Glyphosate;
`Pesticide Tolerances, 73 Fed. Reg. 73,586, 73,589 (Dec. 3, 2008).
`12 See EPA, Office of Pesticide Programs, Revised Glyphosate
`Issue Paper: Evaluation of Carcinogenic Potential (Dec. 12,
`2017),
`usrtk.org/wp-
`content/uploads/2019/04/REVISED_GLYPHOSATE_ISSUE_
`PAPER_EVALUATION_OF_CARCINOGENIC_POTENTIAL-
`1.pdf.
`13 Id. at 144.
`14 Id.
`15 Id.
`
`
`
`
`
`13
`
`International Agency for Research of Cancer (IARC)
`announced its view, upon which glyphosate plaintiffs
`nationwide base claims, that glyphosate was a
`probable carcinogen.
`
`EPA’s scientific review led to its Draft Human
`Health Risk Assessment, which, after notice and
`comment, concluded that glyphosate was not likely to
`cause cancer.16 After considering thousands of public
`comments, EPA
`issued
`its
`“Proposed Interim
`Registration Review Decision,” reaffirming that its
`“independent evaluation of the carcinogenic potential
`of glyphosate . . . has determined that glyphosate is
`‘not likely to be carcinogenic to humans.’”17 EPA
`expressly
`rejected
`IARC’s
`cancer
`conclusion,
`explaining that EPA’s “cancer evaluation is more
`robust
`than
`IARC’s evaluation,” which
`“only
`considered a subset of the studies included in the
`EPA’s evaluation” and included “some studies that
`were not appropriate for determining the human
`carcinogenic potential of glyphosate.”18
`
`After this extensive process, EPA’s Office of
`Pesticide Programs sent an August 2019 letter to all
`glyphosate registrants, reiterating that it “disagrees
`with IARC’s assessment of glyphosate.”19 EPA noted
`
`16 See EPA, Glyphosate: Draft Human Health Risk
`Assessment in Support of Registration Review, Case No. 0178
`(Dec. 12, 2017), www.regulations.gov/document/EPA-HQ-OPP-
`2009-0361-0068.
`17 See EPA, Glyphosate: Proposed Interim Registration
`Review Decision, Case No. 0178, at 7
`(Apr. 2019),
`www.regulations.gov/document?D=EPA-HQ-OPP-2009-0361-
`2344.
`18 Id.
`19 EPA Letter 1.
`
`
`
`
`
`14
`
`that its cancer classification is “consistent with other
`international
`expert
`panels
`and
`regulatory
`authorities,” including government regulators in
`Canada, Australia, Germany, and New Zealand, as
`well as the European Food Safety Authority and
`European Chemical Agency.20
` EPA notified
`registrants that glyphosate products that do bear a
`cancer warning would be “misbranded pursuant to”
`FIFRA.21
`
`In January 2020, following another comment
`period, EPA issued its interim registration review
`decision.22 EPA confirmed its longstanding conclusion
`
`
`20 Id.; see, e.g., European Food Safety Authority, Glyphosate:
`EFSA Updates Toxicological Profile (Nov. 12, 2015) (glyphosate
`is “unlikely to pose a carcinogenic hazard to humans”),
`www.efsa.europa.eu/en/press/news/151112;
`European
`Chemicals Agency, Glyphosate Not Classified as a Carcinogen by
`ECHA (Mar. 15, 2017) (“available scientific evidence did not meet
`the criteria
`to classify glyphosate as a carcinogen”),
`echa.europa.eu/-/glyphosate-not-classified-as-a-carcinogen-by-
`echa; Federal Institute for Risk Assessment (BfR, Germany), BfR
`Comm’cn No. 007/2015, Does Glyphosate Cause Cancer?
`(assessment “supported by competent national, European and
`other
`international
`institutions
`for health assessment”),
`www.bfr.bund.de/cm/349/does-glyphosate-cause-cancer.pdf.
`
`EPA’s determination is even consistent with the conclusions
`of “other agencies within the World Health Organization,” aside
`from IARC, “that there is insufficient or no evidence that
`glyphosate causes cancer.” National Association of Wheat
`Growers v. Becerra, 468 F. Supp. 3d 1247, 1252 (E.D. Cal. 2020).
`21 EPA Letter 1.
`22 See EPA, Glyphosate: Interim Registration Review
`Decision,
`Case No.
`0178,
`at
`5
`(Jan.
`2020),
`www.epa.gov/sites/production/files/2020-
`01/documents/glyphosate-interim-reg-review-decision-case-
`num-0178.pdf.
`
`
`
`
`
`15
`
`that glyphosate does not cause cancer in humans:
`“None of the open literature studies identified for the
`agency’s consideration were found to have an impact
`on the glyphosate hazard characterization, cancer
`assessment, or human health risk assessment.”23
`EPA reaffirmed that it had “thoroughly evaluated
`potential human health risk associated with exposure
`to glyphosate and determined that there are no risks
`to human health from the current registered uses of
`glyphosate and that glyphosate is not likely to be
`carcinogenic to humans.”24
`
`In a recent Ninth Circuit brief, EPA reiterated that
`it stands by its “conclu[sion] that glyphosate is not
`likely to be a human carcinogen and that it does not
`pose human-health risks of concern.” EPA Br. 17,
`NRDC v. EPA, Nos. 20-70787, 20-70801 (9th Cir. May
`18, 2021); see also, e.g., id. at 30. It did so even as it
`asked the Ninth Circuit for “partial voluntary remand
`of the portions of the Interim Decision that do not
`relate to its conclusions on human health risks.” EPA
`Motion for Partial Remand Without Vacatur 1-2,
`NRDC v. EPA, Nos. 20-70787, 20-70801 (9th Cir. May
`18, 2021).
`
`2. The Ninth Circuit recognized this consistent
`EPA finding, but rejected it out of hand on the grounds
`that the EPA determinations do not have “the force of
`law.” Pet. App. 15a-17a. For the reasons stated in the
`Petition, however, the Court of Appeals asked the
`
`
`
`23 Id. at 6-7.
`24 Id. at 10; see also id. at 9 (EPA “thoroughly assessed risks
`to humans from exposure to glyphosate from all registered uses
`and all routes of exposure and did not identify any risks of
`concern”); id. at 15.
`
`
`
`
`
`16
`
`wrong question. Pet. at 16. But even assuming that
`the “force of law” question is an inquiry appropriate to
`express preemption, the Court of Appeals simply got
`it wrong: EPA’s
`repeated non-carcinogenicity
`determinations do, in fact, have the force of law.
`
`Generally, “Congress contemplates administrative
`action with the effect of law when it provides for a
`relatively formal administrative procedure tending to
`foster the fairness and deliberation that should
`underlie a pronouncemen
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