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`Case: 20-16758, 05/12/2021, ID: 12111320, DktEntry: 38, Page 1 of 94
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`No. 20-16758
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`
`
`UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`
`
`
`NATIONAL ASSOCIATION OF WHEAT GROWERS, ET AL.,
`Plaintiffs-Appellees,
`v.
`ROB BONTA,* ATTORNEY GENERAL OF CALIFORNIA, ET AL.,
`Defendants-Appellants.
`
`On Appeal from the United States District Court for the
`Eastern District of California, Case No. 2:17-cv-02401-WBS-EFB
`Honorable William B. Shubb
`
`
`
`
`
`
`
`
`
`ANSWERING BRIEF OF PLAINTIFFS-APPELLEES
`NATIONAL ASSOCIATION OF WHEAT GROWERS, ET AL.
`
`Richard P. Bress
`Philip J. Perry
`Andrew D. Prins
`Tyce R. Walters
`Nicholas L. Schlossman
`Ryan S. Baasch
`LATHAM & WATKINS LLP
`555 Eleventh Street, NW, Suite 1000
`Washington, DC 20004
`Telephone: (202) 637-2200
`Attorneys for Appellees Monsanto
`Company and CropLife America
`
`
`
`Catherine L. Hanaway
`Matthew P. Diehr
`Natalie R. Holden
`HUSCH BLACKWELL LLP
`190 Carondelet Plaza, Suite 600
`St. Louis, Missouri 63105
`Telephone: (314) 480-1903
`Attorneys for Appellees National Assoc.
`of Wheat Growers, National Corn
`Growers Assoc., U.S. Durum Growers
`Assoc., Monsanto Company, Missouri
`Farm Bureau, Iowa Soybean Assoc.,
`South Dakota Agri-Business Assoc.,
`North Dakota Grain Growers Assoc.,
`Missouri Chamber of Commerce and
`Industry, Agribusiness Assoc. of Iowa,
`and Associated Industries of Missouri
`(additional counsel on signature page)
`
`* Following Defendant Xavier Becerra’s confirmation as HHS Secretary, Rob Bonta
`was confirmed as the Attorney General of California on April 22, 2021. See Fed. R.
`App. P. 43(c).
`
`

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`Case: 20-16758, 05/12/2021, ID: 12111320, DktEntry: 38, Page 2 of 94
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`CORPORATE DISCLOSURE STATEMENT
`
`Pursuant to Federal Rule of Appellate Procedure 26.1, Defendants-Appellees
`
`
`
`make the following disclosures.
`
`Defendants-Appellees National Association of Wheat Growers, National
`
`Corn Growers Association, U.S. Durum Growers Association, Missouri Farm
`
`Bureau Federation, Iowa Soybean Association, South Dakota Agri-Business
`
`Association, North Dakota Grain Growers Association, Missouri Chamber of
`
`Commerce and Industry, Agribusiness Association of Iowa, Associated Industries
`
`of Missouri, CropLife America, Western Plant Health Association, and Agricultural
`
`Retailers Association have no parent corporations and no publicly held corporations
`
`own 10% or more of any of these Defendants-Appellees’ stock.
`
`Defendant-Appellee Monsanto Company is an indirect, wholly owned
`
`subsidiary of Bayer AG. Bayer AG is a publicly held corporation. No other publicly
`
`held corporation owns 10% or more of Monsanto Company’s stock.
`
`
`
`
`
`i
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`

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`
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`TABLE OF CONTENTS
`
`B.
`
`C.
`
`Page
`CORPORATE DISCLOSURE STATEMENT .......................................................... i
`TABLE OF AUTHORITIES .................................................................................... iv
`INTRODUCTION ..................................................................................................... 1
`STATEMENT OF THE ISSUES............................................................................... 6
`STATEMENT OF ADDENDUM ............................................................................. 6
`STATEMENT OF JURISDICTION.......................................................................... 6
`STATEMENT OF THE CASE .................................................................................. 7
`A. GLYPHOSATE IS APPROVED IN THE UNITED STATES
`AS A PESTICIDE, INCLUDING FOR USE ON CROPS AND
`FOOD INPUTS ..................................................................................... 7
`THE INTERNATIONAL SCIENTIFIC CONSENSUS THAT
`GLYPHOSATE DOES NOT CAUSE CANCER ................................ 8
`IARC’S CONTRARY VIEW, AND THE GLOBAL
`REPUDIATION OF THAT VIEW ..................................................... 10
`PROPOSITION 65 .............................................................................. 15
`D.
`OEHHA’S GLYPHOSATE LISTING AND NSRL .......................... 19
`E.
`PROCEDURAL HISTORY ................................................................ 20
`F.
`SUMMARY OF THE ARGUMENT ...................................................................... 25
`STANDARD OF REVIEW ..................................................................................... 27
`ARGUMENT ........................................................................................................... 27
`I.
`THE ATTORNEY GENERAL DOES NOT CONTEST THE
`DISTRICT COURT’S HOLDING THAT THE CORE
`PROPOSITION 65 WARNING VIOLATES THE FIRST
`AMENDMENT AS APPLIED TO GLYPHOSATE .................................... 28
`THE ATTORNEY GENERAL’S ALTERNATIVE WARNING IS A
`RED HERRING ............................................................................................. 29
`A.
`THE PROPER FOCUS OF THE FIRST AMENDMENT
`INQUIRY IS THE CORE WARNING COMPELLED BY
`PROPOSITION 65 .............................................................................. 29
`
`II.
`
`ii
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`

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`Page
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`B.
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`CALIFORNIA’S WARNING DOES NOT COMPLY WITH
`PROPOSITION 65 .............................................................................. 32
`1.
`Proposition 65 requires a warning that the chemical at
`issue causes cancer .................................................................... 32
`The Attorney General cannot evade these established
`standards .................................................................................... 35
`If Proposition 65’s warning requirement were as
`indeterminate as the Attorney General now contends, it
`would be unconstitutional for other reasons ............................. 37
`III. THE ATTORNEY GENERAL’S ALTERNATIVE WARNING
`ALSO VIOLATES THE FIRST AMENDMENT ........................................ 39
`A.
`THE ALTERNATIVE WARNING IS NOT ELIGIBLE FOR
`REVIEW UNDER ZAUDERER ......................................................... 39
`1.
`The Zauderer standard of review applies only to purely
`factual and uncontroversial warnings ....................................... 39
`The district court correctly held that the Alternative
`Warning is ineligible for review under the Zauderer
`standard because it is misleading and, at a minimum,
`controversial .............................................................................. 42
`The Attorney General’s other efforts to evade heightened
`scrutiny are meritless ................................................................ 57
`THE ALTERNATIVE WARNING FAILS CENTRAL
`HUDSON REVIEW ............................................................................ 61
`1.
`Requiring Plaintiffs to convey the Alternative Warning
`would not advance a substantial government interest .............. 62
`Compelling the Alternative Warning would burden more
`speech than necessary ............................................................... 65
`CONCLUSION ........................................................................................................ 67
`
`
`2.
`
`3.
`
`2.
`
`3.
`
`B.
`
`2.
`
`iii
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`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`CASES
`American Beverage Association v. City & County of San Francisco
`(ABA I),
`871 F.3d 884 (9th Cir. 2017) .................................................................. 27, 40, 53
`
`American Beverage Association v. City & County of San Francisco
`(ABA II),
`916 F.3d 749 (9th Cir. 2019) ............................................................ 41, 46, 61, 66
`
`American Meat Institute v. United States Department of Agriculture
`(AMI),
`760 F.3d 18 (D.C. Cir. 2014) ......................................................39, 40, 51, 53, 55
`Amidon v. Student Association of SUNY,
`508 F.3d 94 (2d Cir. 2007) ................................................................................. 51
`Baxter Healthcare Corp. v. Denton,
`120 Cal. App. 4th 333 (2004) ............................................................................. 49
`California Chamber of Commerce v. Becerra,
`No. 2:19-cv-02019-KJM-EFB, 2021 WL 1193829 (E.D. Cal. Mar.
`30, 2021) ....................................................................................................... 38, 48
`California Teachers Association v. State Board of Education,
`271 F.3d 1141, 1150 (9th Cir. 2001) .................................................................. 38
`Central Hudson Gas & Electric Corp. v. Public Service Commission,
`447 U.S. 557 (1980) ........................................................................................ 4, 61
`Consumer Cause, Inc. v. Mrs. Gooch’s Natural Food Markets, Inc.,
`127 Cal. App. 4th 387 (2005) ............................................................................. 17
`Consumer Cause, Inc. v. SmileCare,
`91 Cal. App. 4th 454 (2001) ......................................................................... 17, 19
`Consumer Defense Group v. Rental Housing Industry Members,
`137 Cal. App. 4th 1185 (2006) ..................................................................... 17, 18
`
`iv
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`

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` Page(s)
`
`CTIA – The Wireless Association v. City & County of San Francisco,
`827 F. Supp. 2d 1054 (N.D. Cal. 2011), aff’d, 494 F. App’x 752
`(9th Cir. 2012) ..................................................................................................... 57
`CTIA – The Wireless Association v. City of Berkeley,
`928 F.3d 832 (9th Cir) .................................................................................passim
`DiPirro v. Bondo Corp.,
`153 Cal. App. 4th 150 (2007) ............................................................................. 18
`Doe v. Harris,
`772 F.3d 563 (9th Cir. 2014) .............................................................................. 27
`Dowhal v. SmithKline-Beecham Consumer Healthcare,
`32 Cal. 4th 910 (2004) .................................................................. 3, 16, 30, 32, 38
`ECM BioFilms, Inc. v. FTC,
`851 F.3d 599 (6th Cir. 2017) .............................................................................. 41
`Environmental Law Foundation v. Beech-Nut Nutrition Corp.,
`235 Cal. App. 4th 307 (2015) ............................................................................. 19
`
`Hardeman v. Monsanto Co. (In re Roundup Products Liability
`Litigation),
`385 F. Supp. 3d 1042 (N.D. Cal. 2019) ........................................................ 14, 44
`Ibanez v. Florida Department of Business & Professional Regulation,
`512 U.S. 136 (1994) ............................................................................................ 28
`Johanns v. Livestock Marketing Ass’n,
`544 U.S. 550 (2005) ............................................................................................ 59
`Loan Payment Administration LLC v. Hubanks,
`821 F. App’x 687 (9th Cir. 2020) ....................................................................... 55
`Milavetz, Gallop & Milavetz, P.A. v. United States,
`559 U.S. 229 (2010) ...................................................................................... 31, 55
`Monsanto Co. v. OEHHA,
`22 Cal. App. 5th 534 (2018) ............................................................................... 47
`
`v
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` Page(s)
`
`National Association of Manufacturers v. SEC,
`800 F.3d 518 (D.C. Cir. 2015) ................................................................ 46, 54, 62
`National Electrical Manufacturers Association v. Sorrell,
`272 F.3d 104 (2d Cir. 2001) ......................................................................... 55, 60
`National Institute of Family & Life Advocates v. Becerra (NIFLA),
`138 S. Ct. 2361 (2018) .................................................................................passim
`
`New York State Restaurant Association v. New York City Board of
`Health,
`556 F.3d 114 (2d Cir. 2009) ......................................................................... 55, 60
`Nicolle-Wagner v. Deukmejian,
`230 Cal. App. 3d 652 (1991) .............................................................................. 63
`Nicopure Labs, LLC v. FDA,
`944 F.3d 267 (D.C. Cir. 2019) ............................................................................ 41
`
`Pacific Gas & Electric Co. v. Public Utilities Commission of
`California,
`475 U.S. 1 (1986) ................................................................................................ 30
`People ex rel. Lockyer v. Tri-Union Seafoods,
`No. CGC-01-402975, 2006 WL 1544384 (Cal. Super. Ct. May 11,
`2006), aff’d, 171 Cal. App. 4th 1549 (2009) ................................................ 33, 36
`POM Wonderful, LLC v. FTC,
`777 F.3d 478 (D.C. Cir. 2015) ............................................................................ 41
`R.J. Reynolds Tobacco Co. v. FDA,
`696 F.3d 1205 (D.C. Cir. 2012), overruled in part on other
`grounds by American Meat Institute v. United States Department
`of Agriculture, 760 F.3d 18 (D.C. Cir. 2014) ............................................... 40, 65
`Rice v. Fox Broadcasting Co.,
`330 F.3d 1170 (9th Cir. 2003) ............................................................................ 53
`Riley v. National Federation of the Blind of North Carolina, Inc.,
`487 U.S. 781 (1988) ............................................................................................ 38
`
`vi
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`
`
` Page(s)
`
`In re Roundup Products Liability Litigation,
`390 F. Supp. 3d 1102 (N.D. Cal. 2019) ............................................ 10, 11, 14, 15
`Sciortino v. Pepsico, Inc.,
`108 F. Supp. 3d 780 (N.D. Cal. 2015) ................................................................ 19
`Stevens v. CoreLogic, Inc.,
`899 F.3d 666 (9th Cir. 2018) .............................................................................. 27
`United States v. Virginia,
`518 U.S. 515 (1996) ............................................................................................ 64
`Video Software Dealers Association v. Schwarzenegger,
`556 F.3d 950 (9th Cir. 2009), aff’d sub nom. Brown v.
`Entertainment Merchants Association, 564 U.S. 786 (2011) ............................. 62
`
`Zauderer v. Office of Disciplinary Counsel of the Supreme Court of
`Ohio,
`471 U.S. 626 (1985) ...................................................................... 1, 38, 39, 41, 55
`FEDERAL STATUTES AND REGULATIONS
`7 U.S.C. § 136(bb) ..................................................................................................... 8
`7 U.S.C. § 136a .......................................................................................................... 7
`7 U.S.C. § 136a(c)(5)(C) ............................................................................................ 8
`7 U.S.C. § 136a(c)(5)(D) ........................................................................................... 8
`21 U.S.C. § 331(b) ..................................................................................................... 8
`21 U.S.C. § 342(a) ..................................................................................................... 8
`21 U.S.C. § 346a ........................................................................................................ 8
`21 U.S.C. § 346a(b)(2)(A) ......................................................................................... 8
`21 U.S.C. § 346a(b)(2)(A)(ii) .................................................................................... 9
`40 C.F.R. § 156.10(g) .............................................................................................. 66
`40 C.F.R. § 180.364 ................................................................................................... 9
`
`vii
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` Page(s)
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`STATE STATUTES AND REGULATIONS
`Cal. Health & Safety Code § 25249.6 ........................................................... 3, 16, 30
`Cal. Health & Safety Code § 25249.7(a) ................................................................. 17
`Cal. Health & Safety Code § 25249.7(b) ................................................................. 16
`Cal. Health & Safety Code § 25249.7(c) ................................................................. 17
`Cal. Health & Safety Code § 25249.7(d) ................................................................. 17
`Cal. Health & Safety Code § 25249.7(d)(1) ............................................................ 18
`Cal. Health & Safety Code § 25249.7(e)(1)(A) ....................................................... 18
`Cal. Health & Safety Code § 25249.8(a) ................................................................. 15
`Cal. Health & Safety Code § 25249.10(c) ............................................................... 18
`Cal. Health & Safety Code § 25249.11(e) ............................................................... 17
`Cal. Labor Code § 6382(b)(1) .................................................................................. 15
`Cal. Veh. Code Ann. § 27363.5 ............................................................................... 60
`Cal. Code Regs. tit. 11, § 3201 ................................................................................ 17
`Cal. Code Regs. tit. 11, § 3202(b)...................................................................... 33, 34
`Cal. Code Regs. tit. 11, § 3203(b)............................................................................ 17
`Cal. Code Regs. tit. 11, § 3203(d)............................................................................ 17
`Cal. Code Regs. tit. 27, § 25601(e) .......................................................................... 33
`Cal. Code Regs. tit. 27, § 25603(a) .......................................................................... 16
`Cal. Code Regs. tit. 27, § 25603(b) ......................................................................... 16
`Cal. Code Regs. tit. 27, § 25701(d) ......................................................................... 49
`Cal. Code Regs. tit. 27, § 25701(b)(3)(A) ............................................................... 49
`
`viii
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` Page(s)
`Cal. Code Regs. tit. 27, § 25703(a)(3) ..................................................................... 49
`Cal. Code Regs. tit. 27, § 25904(c) .......................................................................... 15
`N.Y.C. Rules & Regs., tit. 1, § 27-01 ...................................................................... 60
`OTHER AUTHORITIES
`78 Fed. Reg. 60,707 (2013) ....................................................................................... 9
`Baum Hedlund, Where Is Glyphosate Banned?,
`https://www.baumhedlundlaw.com/toxic-tort-law/monsanto-
`roundup-lawsuit/where-is-glyphosate-banned-/ (updated Apr.
`2021) ................................................................................................................... 13
`Merriam-Webster’s Collegiate Dictionary (10th ed. 1993) ..................................... 42
`San Francisco Dep’t of Health, Director’s Rules & Regs., Garbage &
`Refuse (July 8, 2010), https://www.sfdph.org/dph/files/EHSdocs/
`SolidWaste/RefuseService.pdf ........................................................................... 60
`U.S. EPA, Evaluating Pesticides for Carcinogenic Potential,
`https://www.epa.gov/pesticide-science-and-assessing-pesticide-
`risks/evaluating-pesticides-carcinogenic-potential (last visited May
`12, 2021) ............................................................................................................. 50
`
`
`
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`
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`INTRODUCTION
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`This case concerns a new compelled warning for glyphosate, the most widely
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`used herbicide in the world, and one of the most thoroughly studied. Glyphosate has
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`been subject to decades of examination by regulators worldwide. Every expert
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`national regulator to have assessed the safety of glyphosate—including the United
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`States EPA and regulators in Europe, Canada, Australia, New Zealand, Japan, and
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`South Korea—has concluded that glyphosate does not cause cancer. And the only
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`times it considered that question, California’s own Office of Environmental Health
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`Hazard Assessment (OEHHA) came to the same conclusion. Yet, because a single
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`entity, the International Agency for Research on Cancer (IARC), concluded that
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`glyphosate probably is capable of causing cancer (at unspecified exposure levels),
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`California’s Proposition 65 requires that every product containing even small
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`amounts of glyphosate display a warning telling consumers that glyphosate is a
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`chemical “known to the state of California to cause cancer.”
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`Laws that compel speech, just like laws that restrict speech, are presumptively
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`unconstitutional, and are ordinarily subject to at least intermediate scrutiny. See
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`Nat’l Inst. of Family & Life Advocates v. Becerra (NIFLA), 138 S. Ct. 2361, 2371
`
`(2018). The Supreme Court has articulated a narrow exception, permitting more
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`streamlined review of certain compelled commercial disclosures under the standard
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`articulated in Zauderer v. Office of Disciplinary Counsel of the Supreme Court of
`
`1
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`

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`Ohio, 471 U.S. 626, 651 (1985)—but that standard applies only where the disclosure
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`consists of “purely factual and uncontroversial” information, such as ingredient lists,
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`calorie counts, country-of-origin designations, and well-established health risks.
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`The compelled warning requirement at issue in this case is nothing like that.
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`The problem here is that the compelled Proposition 65 warning would convey
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`the message that it is an established fact that glyphosate causes cancer when, in
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`actuality, the vast weight of scientific authority is to the contrary. Plaintiffs, a broad
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`coalition of agricultural and farming associations and businesses, filed suit to enjoin
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`enforcement of Proposition 65’s warning requirement as applied to glyphosate. In
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`granting their motion for summary judgment, the district court held that this
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`compelled warning would be false or, at a minimum, deeply misleading, and that
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`compelling it violates the First Amendment.
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`On appeal, the Attorney General no longer defends the lawfulness of the
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`standard Proposition 65 warning as applied to glyphosate. Instead, he champions a
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`supposed “alternative” warning (the “Alternative Warning”) that he proposed in
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`summary judgment briefing below. This Alternative Warning would acknowledge
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`that IARC’s finding is the basis of the “known to cause cancer” language and would
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`note EPA’s disagreement with IARC. According to the Attorney General, the
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`availability of this alternative warning rescues Proposition 65’s application to
`
`2
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`

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`
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`glyphosate from its constitutional flaws. The district court rightly rejected this
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`argument as well.
`
`The Attorney General’s reliance on the Alternative Warning is misplaced
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`because it adds qualifying language that is both irrelevant to the constitutional
`
`analysis and noncompliant with Proposition 65. The Attorney General’s own brief
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`concedes that what California law requires is a “‘clear and reasonable’” warning that
`
`a chemical is “‘known to the state to cause cancer’ or ‘words to that effect.’” Br. 13
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`(alteration omitted) (quoting Cal. Health & Safety Code § 25249.6 and Dowhal v.
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`SmithKline-Beecham Consumer Healthcare, 32 Cal. 4th 910, 918 (2004)). And it is
`
`that message—the speech that state law compels; not whatever additional
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`explanatory statements state law might allow—that is the proper focus of the First
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`Amendment analysis. In addition, the Alternative Warning is not actually an
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`available option because—under controlling California precedent and per the
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`Attorney General’s own regulations—Proposition 65 forbids the addition of any
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`language that would undermine the certitude of the core required warning. For both
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`of these reasons, the district court’s judgment can and should be affirmed without
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`any need for this Court to consider whether compelling the Alternative Warning also
`
`would violate the First Amendment. But if the Court reaches that question, it should
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`affirm on that basis, too.
`
`3
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`

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`Like the core Proposition 65 warning, the Alternative Warning is both
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`misleading and controversial. The Alternative Warning (1) retains the core
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`statement that glyphosate is “known to cause cancer,” (2) tells consumers that
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`California reached this conclusion because the weighty-sounding “International
`
`Agency for Research on Cancer has classified it as a carcinogen,” and (3) only
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`briefly notes at the tail end (if consumers read that far) that EPA believes glyphosate
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`is not likely carcinogenic. Thus, the Alternative Warning would convey to
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`reasonable consumers that the weight of authority is that glyphosate causes cancer
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`or, at best, that authoritative bodies are split equally on that question—and both of
`
`those messages are false. Moreover, the Alternative Warning would unquestionably
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`require Plaintiffs to wade into a scientific controversy and present viewpoints with
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`which they strongly disagree, which independently renders it ineligible for review
`
`under the Zauderer standard.
`
`The Alternative Warning would therefore be evaluated under the intermediate
`
`scrutiny standard of Central Hudson Gas & Electric Corp. v. Public Service
`
`Commission, 447 U.S. 557 (1980)—and as the district court held, the Attorney
`
`General failed to prove that it could survive either element of that test. First,
`
`compelling the Alternative Warning would not directly advance a substantial state
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`interest. As this Court has previously recognized, the State has no legitimate interest,
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`much less a substantial interest, in misleading consumers. In addition, the interest
`
`4
`
`

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`
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`the Attorney General now invokes—informing consumers whenever one of a
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`handful of entities determines that a chemical probably causes cancer, even if most
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`authorities disagree—was explicitly disclaimed in the Proposition 65 ballot
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`summary, which told the voters who enacted the statute that it would require
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`businesses to warn consumers about “chemicals that are scientifically known[,] not
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`merely suspected, but known[] to cause cancer.” 2-ER-121. Second, as applied to
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`glyphosate, compelling a Proposition 65 warning burdens First Amendment
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`freedoms more than necessary to advance the State’s purported interests. As the
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`district court concluded, to the extent the State wishes to inform consumers about
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`IARC’s views about glyphosate, the Attorney General did not meet his burden to
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`show that the State could not advance that interest, without burdening private speech,
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`by providing consumers that information itself. Indeed, the Attorney General
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`introduced no evidence whatsoever on that score—a failure that, by itself, is fatal.
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`The Attorney General and his amici protest that unless this Court overturns
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`the district court’s narrow and well-reasoned decision, the sky will fall and all of this
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`Nation’s health and safety warnings will be at risk. They insist, in particular, that
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`governments will never be able to require warnings over which there is any
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`“scientific disagreement,” Br. 58, and will be unable to warn the public of emerging
`
`health risks. That is nonsense. Despite the Attorney General’s efforts to cast his
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`appeal in apocalyptic terms, he lost this case for more prosaic reasons. The district
`
`5
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`

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`
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`court followed established precedent to enjoin a warning requirement that is
`
`inconsistent with the overwhelming weight of scientific authority. Its decision casts
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`no doubt on the government’s ability to require warnings about established risks to
`
`health and safety. And it equally casts no doubt on the government’s ability to
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`require warnings about serious emerging risks; such warning mandates are
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`permissible where (unlike here) the State can demonstrate that the warnings are not
`
`misleading, that the State cannot effectively disseminate the warnings itself, and that
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`the warning mandates satisfy the other requirements of intermediate scrutiny.
`
`This Court should affirm the decision of the district court.
`
`STATEMENT OF THE ISSUES
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`Whether, in light of the consensus among EPA and other national regulators
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`that glyphosate is not a human carcinogen, the district court correctly held that the
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`First Amendment bars California from compelling Plaintiffs to provide a Proposition
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`65 cancer warning for products containing glyphosate.
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`STATEMENT OF ADDENDUM
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`Pertinent constitutional provisions, statutes, and rules are set forth in the
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`Addendum.
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`STATEMENT OF JURISDICTION
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`Plaintiffs concur that the district court had and this Court has jurisdiction, and
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`that this appeal was timely filed, as stated by the Attorney General.
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`Case: 20-16758, 05/12/2021, ID: 12111320, DktEntry: 38, Page 17 of 94
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`STATEMENT OF THE CASE
`A. Glyphosate Is Approved In the United States As A Pesticide,
`Including For Use On Crops And Food Inputs
`Glyphosate is an herbicide used to control weeds in agricultural, residential,
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`and other settings. SER237-40 (¶¶ 6-17). It is the world’s most widely used
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`herbicide. See SER237; SER277. Glyphosate serves as the active ingredient in
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`many commercial products, including most Roundup® products, and has been
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`registered for use in over 160 countries. SER237, 245, 259 (¶¶ 8, 9, 31-32, 67).
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`In the United States, glyphosate is approved for use in more than 250
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`agricultural crop applications. SER239, 244-45 (¶¶ 13, 30-31); see also, e.g.,
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`SER318-19. Glyphosate-based herbicides are also widely used in garden settings,
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`by government agencies to control vegetation in aquatic environments, and to reduce
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`wildfire risk. SER240 (¶ 16). Glyphosate is broadly used because of its well-
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`recognized benefits over other weed-suppression techniques, including its lesser
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`environmental impacts.1
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`Glyphosate is subject to comprehensive federal regulation. Under the Federal
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`Insecticide, Fungicide, and Rodenticide Act (FIFRA), commercial herbicides such
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`as glyphosate must be registered with EPA. 7 U.S.C. § 136a. Before EPA can grant
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`1 See, e.g., SER239-40 (¶¶ 15, 17); SER282; SER1021-22 (¶¶ 5-7); SER1062
`(¶ 6); SER1091-92 (¶¶ 5-9); SER1079-80 (¶¶ 7-10); SER1031-33 (¶¶ 6-12);
`SER1042-43 (¶¶ 5-8).
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`Case: 20-16758, 05/12/2021, ID: 12111320, DktEntry: 38, Page 18 of 94
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`registration, it must conclude that the herbicide will not cause “any unreasonable
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`risk to man or the environment” or “human dietary risk.” Id. § 136(bb); see id.
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`§ 136a(c)(5)(C)-(D). This review includes a mandatory evaluation of whether the
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`herbicide is potentially carcinogenic. See, e.g., SER292-313. The Federal Food,
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`Drug, and Cosmetic Act (FDCA) then regulates the presence of registered herbicides
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`on food products. 21 U.S.C. §§ 342(a), 331(b), 346a. Under the FDCA, EPA is
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`charged with evaluating the human health impact of the presence of the herbicide’s
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`food residue, including potential carcinogenicity. Id. § 346a(b)(2)(A).
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`B.
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`The International Scientific Consensus That Glyphosate Does Not
`Cause Cancer
`Because of its immense popularity, glyphosate is one of the most studied
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`herbicides in the world. Regulators worldwide, including EPA, have recognized for
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`decades that glyphosate is safe when used as directed, and have uniformly concluded
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`that glyphosate poses no risk of cancer.
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`EPA has repeatedly reached and re-affirmed this conclusion. “In June 1991,
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`EPA classified glyphosate as a Group E oncogene—one that shows evidence of non-
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`carcinogenicity for humans—based on the lack of convincing evidence of
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`carcinogenicity in adequate