Case: 19-16636, 12/13/2019, ID: 11532491, DktEntry: 27, Page 1 of 105
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`Nos. 19-16636, 19-16708
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`UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`
`EDWIN HARDEMAN,
`Plaintiff-Appellee/Cross-Appellant,
`
`v.
`MONSANTO COMPANY,
`Defendant-Appellant/Cross-Appellee.
`
`On Appeal from the United States District Court
`for the Northern District of California,
`Nos. 16-cv-00525 & 16-md-02741 (Chhabria, J.)
`
`FIRST STEP BRIEF FOR MONSANTO COMPANY
`
`
`BRIAN L. STEKLOFF
`RAKESH KILARU
`WILKINSON WALSH AND
` ESKOVITZ LLP
`2001 M Street, NW
`10th Floor
`Washington, DC 20036
`
`PHILIP J. PERRY
`RICHARD P. BRESS
`LATHAM & WATKINS LLP
`555 Eleventh Street, NW
`Suite 1000
`Washington, DC 20004
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`SETH P. WAXMAN
`PAUL R.Q. WOLFSON
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`1875 Pennsylvania Ave., NW
`Washington, DC 20006
`(202) 663-6000
`seth.waxman@wilmerhale.com
`
`THOMAS G. SPRANKLING
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`950 Page Mill Road
`Palo Alto, CA 94304
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`December 13, 2019
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`ADDITIONAL COUNSEL LISTED ON INSIDE COVER
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`Case: 19-16636, 12/13/2019, ID: 11532491, DktEntry: 27, Page 2 of 105
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`LEON T. KENWORTHY
`CLAIRE H. CHUNG
`JAMES BARTON
`RAFAEL J. GALLARDO HEVIA
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`1875 Pennsylvania Ave., NW
`Washington, DC 20006
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`HENRY J. BECKER
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`950 Page Mill Road
`Palo Alto, CA 94304
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`MICHAEL X. IMBROSCIO
`DAVID M. ZIONTS
`COVINGTON & BURLING LLP
`One CityCenter
`850 Tenth Street, NW
`Washington, DC 20001
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`LEE MARSHALL
`BRYAN CAVE LEIGHTON
` PAISNER LLP
`Three Embarcadero Center
`7th Floor
`San Francisco, CA 94111
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`CORPORATE DISCLOSURE STATEMENT
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`
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`Pursuant to Federal Rule of Appellate Procedure 26.1, Defendant-
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`Appellant/Cross-Appellee Monsanto Company certifies that it is an indirect,
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`wholly owned subsidiary of Bayer AG and that Bayer AG is a publicly held
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`corporation. No other publicly held corporation owns 10% or more of Monsanto
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`Company’s stock.
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`TABLE OF CONTENTS
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`Page
`CORPORATE DISCLOSURE STATEMENT .......................................................... i 
`
`TABLE OF AUTHORITIES ..................................................................................... v 
`
`INTRODUCTION ..................................................................................................... 1 
`
`JURISDICTION ......................................................................................................... 3 
`
`ISSUES ON APPEAL ............................................................................................... 3 
`
`CONSTITUTIONAL AND STATUTORY PROVISIONS
`INVOLVED ..................................................................................................... 4 
`
`STATEMENT ............................................................................................................ 5 
`
`A.  Glyphosate’s Longstanding Record Of Regulatory
`Approvals And Findings Of Non-Carcinogenicity ............................... 5 
`1. 
`EPA approves glyphosate for sale and determines
`that it is not carcinogenic ............................................................ 5 
`
`2. 
`
`3. 
`
`IARC’s incomplete finding ......................................................... 7 
`
`EPA and other agencies reaffirm their conclusions
`that glyphosate is not carcinogenic ............................................. 8 
`
`Hardeman’s Complaint And Allegations ............................................ 11 
`Pretrial Proceedings ............................................................................. 12 
`1. 
`Preemption ................................................................................ 12 
`
`2. 
`
`3. 
`
`Expert testimony on causation .................................................. 13 
`
`Evidence about regulatory conclusions .................................... 14 
`
`Trial ..................................................................................................... 15 
`1. 
`Phase one (causation) ................................................................ 16 
`
`B. 
`C. 
`
`D. 
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`2. 
`
`Phase two .................................................................................. 18 
`
`E. 
`Post-Trial Proceedings ........................................................................ 18 
`SUMMARY OF ARGUMENT ............................................................................... 19 
`
`STANDARD OF REVIEW ..................................................................................... 23 
`
`ARGUMENT ........................................................................................................... 24 
`
`I. 
`
`II. 
`
`HARDEMAN’S CLAIMS ARE PREEMPTED BY FEDERAL LAW ........................... 24 
`A. 
`FIFRA Requires Uniform Labeling Of Pesticides And
`Forbids States From Adding Labeling Requirements ......................... 26 
`B. 
`Hardeman’s Claims Are Expressly Preempted By FIFRA ................. 28 
`C.  Hardeman’s Claims Are Also Impliedly Preempted By
`FIFRA .................................................................................................. 32 
`THE DISTRICT COURT MISINTERPRETED THE DAUBERT
`STANDARD IN ADMITTING THE CAUSATION OPINIONS OF
`HARDEMAN’S EXPERTS .................................................................................. 40 
`A. 
`The District Court Misinterpreted This Court’s Daubert
`Standard ............................................................................................... 41 
`Under A Proper Application Of Daubert, Hardeman’s
`Experts Should Have Been Excluded ................................................. 48 
`1. 
`On general causation, Hardeman’s experts’
`methodology was flawed because they cherry-
`picked unreliable epidemiological studies that
`could not support their opinions ............................................... 48 
`
`B. 
`
`2. 
`
`On specific causation, Hardeman’s experts’
`differential diagnosis methodology was
`fundamentally unreliable because it ruled out
`likely causes based solely on subjective judgment ................... 55 
`
` 
`
`The experts’ approach failed to adequately
`rule out idiopathy ............................................................ 56 
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` 
`
`The experts’ approach to hepatitis C
`confirms that they employed a results-
`oriented methodology ..................................................... 61 
`
`III.  THE DISTRICT COURT ERRED BY ADMITTING EVIDENCE ABOUT
`THE IARC DETERMINATION WHILE EXCLUDING EVIDENCE OF
`THE REGULATORY CONSENSUS THAT GLYPHOSATE DOES NOT
`CAUSE CANCER .............................................................................................. 63 
`IV.  THE DISTRICT COURT’S CAUSATION INSTRUCTION MISSTATED
`THE LAW AND CONFUSED THE JURY ............................................................. 70 
`V.  HARDEMAN’S FAILURE-TO-WARN CLAIMS FAIL AS A MATTER
`OF LAW .......................................................................................................... 74 
`VI.  HARDEMAN WAS NOT ENTITLED TO ANY PUNITIVE DAMAGES
`AND CERTAINLY NOT QUADRUPLE PUNITIVE DAMAGES ............................... 76 
`A. 
`The Punitive Damages Award Cannot Be Justified Under
`California Law ..................................................................................... 77 
`The Punitive Damages Award Violates The Federal Due
`Process Clause ..................................................................................... 80 
`The District Court’s Reasons For Upholding Quadruple
`Punitive Damages Are Insufficient ..................................................... 84 
`CONCLUSION ........................................................................................................ 87 
`
`C. 
`
`B. 
`
`CERTIFICATE OF COMPLIANCE
`
`ADDENDUM
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`CERTIFICATE OF SERVICE
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`TABLE OF AUTHORITIES
`
`CASES
`
`Page(s)
`
`Allen v. Pennsylvania Engineering Corp., 102 F.3d 194 (5th Cir.
`1996) .............................................................................................................. 67
`Anderson v. Owens-Corning Fiberglas Corp., 810 P.2d 549 (Cal.
`1991) .............................................................................................................. 74
`Arizona v. ASARCO LLC, 773 F.3d 1050 (9th Cir. 2014) ....................................... 24
`Arizona v. United States, 567 U.S. 387 (2012) .................................................. 23, 38
`B.K.B. v. Maui Police Department, 276 F.3d 1091 (9th Cir. 2002) ........................ 69
`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)................. 57
`BMW of North America v. Gore, 517 U.S. 559 (1996) ......................... 81, 82, 83, 84
`City of New York v. Pullman Inc., 662 F.2d 910 (2d Cir. 1981) ....................... 64, 66
`Clausen v. M/V NEW CARISSA, 339 F.3d 1049 (9th Cir. 2003) ............................. 56
`Cooper v. Takeda Pharmaceuticals America, Inc., 191 Cal. Rptr. 3d
`67 (Ct. App. 2015) ......................................................................................... 52
`CTIA-The Wireless Ass’n v. City & County of San Francisco, 827 F.
`Supp. 2d 1054 (N.D. Cal. 2011) .................................................................... 66
`Curtis v. M&S Petroleum, Inc., 174 F.3d 661 (5th Cir. 1999) ................................ 66
`Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993) ............. 13, 42
`Daubert v. Merrell Dow Pharmaceuticals, Inc., 43 F.3d 1311 (9th Cir.
`1995) ............................................................................................ 42, 47, 53, 59
`Domingo ex rel. Domingo v. T.K., 289 F.3d 600 (9th Cir. 2002) ............................ 49
`Elsayed Mukhtar v. California State University, Hayward, 299 F.3d
`1053 (9th Cir. 2002) ...................................................................................... 47
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`Erhardt v. Brunswick, 231 Cal. Rptr. 60 (Ct. App. 1986) ....................................... 78
`Estate of Barabin v. AstenJohnson, Inc., 740 F.3d 457 (9th Cir. 2014) ........... 23, 47
`Finn v. G.D. Searle & Co., 677 P.2d 1147 (Cal. 1984) ........................................... 76
`Geier v. American Honda Motor Co., 529 U.S. 861 (2000) .................................... 38
`General Electric Co. v. Joiner, 522 U.S. 136 (1997) ........................................ 42, 55
`Hall v. Conoco Inc., 886 F.3d 1308 (10th Cir. 2018) .............................................. 57
`Huskey v. Ethicon, Inc., 848 F.3d 151 (4th Cir. 2017) ............................................ 65
`
`In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices &
`Products Liability Litigation, 892 F.3d 624 (4th Cir. 2018) ......................... 43
`In re Zoloft (Sertraline Hydrochloride) Products Liability Litigation,
`858 F.3d 787 (3d Cir. 2017) .......................................................................... 42
`Johnson & Johnson Talcum Power Cases (Echeverria), 249 Cal. Rptr.
`3d 642 (Ct. App. 2019) ..........................................................78, 79, 80, 84, 85
`Kaffaga v. Estate of Steinbeck, 938 F.3d 1006 (9th Cir. 2019) ............................... 24
`Kilpatrick v. Breg, Inc., 613 F.3d 1329 (11th Cir. 2010) ........................................ 57
`Lakeside-Scott v. Multnomah County, 556 F.3d 797 (9th Cir. 2009) ...................... 24
`Landsgraf v. USI Film Products, 511 U.S. 244 (1994) ........................................... 82
`Major v. R.J. Reynolds Tobacco Co., 222 Cal. Rptr. 3d 563 (Ct. App.
`2017) .............................................................................................................. 71
`Mathis v. Milgard Manufacturing, Inc., 2018 WL 2095757 (S.D. Cal.
`May 7, 2018) .................................................................................................. 76
`McClain v. Metabolife International, Inc., 401 F.3d 1233 (11th Cir.
`2005) .............................................................................................................. 43
`Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) ......................................................... 32
`Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019) ............ 33, 34, 35
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`Messick v. Novartis Pharmaceuticals Corp., 747 F.3d 1193 (9th Cir.
`2014) .................................................................................................. 43, 45, 47
`Milward v. Rust-Oleum Corp., 820 F.3d 469 (1st Cir. 2016) .................................. 57
`Mitchell v. Gonzales, 819 P.2d 872 (Cal. 1991) ...................................................... 73
`Murray v. Southern Route Maritime SA, 870 F.3d 915 (9th Cir. 2017) .................. 42
`Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) ................................. 39
`National Association of Wheat Growers v. Zeise, 2018 WL 3000488
`(E.D. Cal. June 12, 2018) ........................................................................ 64, 75
`National Association of Wheat Growers v. Zeise, 309 F. Supp. 3d 842
`(E.D. Cal. 2018) ......................................................................................... 9, 10
`Nathan v. Kimmel, Inc. v. DowElanco, 275 F.3d 1199 (9th Cir. 2002) .................. 23
`Old Chief v. United States, 519 U.S. 172 (1997) ..................................................... 23
`Pacific Gas & Electric Co. v. Superior Court, 235 Cal. Rptr. 3d 228
`(Ct. App. 2018) .............................................................................................. 77
`Peralta v. Dillard, 744 F.3d 1076 (9th Cir. 2014) ................................................... 24
`Philip Morris USA v. Williams, 549 U.S. 346 (2007) ............................................. 81
`PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) .................................24, 25, 32, 36, 37
`Reckitt Benckiser Inc. v. EPA, 613 F.3d 1131 (D.C. Cir. 2010) .............................. 35
`Reid v. Johnson & Johnson, 780 F.3d 952 (9th Cir. 2015) ..................................... 10
`Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) ................................................. 31, 32
`Roby v. McKesson Corp., 219 P.3d 749 (Cal. 2009) ............................................... 83
`Rosa v. Taser International, Inc., 684 F.3d 941 (9th Cir. 2012) ....................... 75, 76
`Ruckelshaus v. Monsanto Co., 467 U.S. 986 (1984) ........................................... 5, 26
`Rutherford v. Owens-Illinois, Inc., 941 P.2d 1203 (Cal. 1997) ............................... 71
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`Smith v. Los Angeles Unified School District, 830 F.3d 843 (9th Cir.
`2016) .............................................................................................................. 10
`Soule v. General Motors Corp., 882 P.2d 298 (Cal. 1994) ..................................... 73
`State Farm Mutual Automobile Insurance Co. v. Campbell,
`538 U.S. 408 (2003)..................................................................... 81, 82, 83, 84
`Tamraz v. Lincoln Electric Co., 620 F.3d 665 (6th Cir. 2010) .................... 43, 57, 63
`Trejo v. Johnson & Johnson, 220 Cal. Rptr. 3d 127 (Ct. App. 2017) ..................... 76
`United States v. Carlton, 512 U.S. 26 (1994) .......................................................... 82
`United States v. Kizeart, 102 F.3d 320 (7th Cir. 1996) ........................................... 68
`United States v. Ramirez-Robles, 386 F.3d 1234 (9th Cir. 2004) ........................... 69
`United States v. Vasquez, 540 F. App’x 623 (9th Cir. 2013) .................................. 66
`United States v. Waters, 627 F.3d 345 (9th Cir. 2010) ............................................ 68
`United States v. Williams, 81 F.3d 1434 (7th Cir. 1996) ......................................... 68
`Viner v. Sweet, 70 P.3d 1046 (Cal. 2003) .......................................................... 71, 72
`Weisgram v. Marley Co., 528 U.S. 440 (2000) ....................................................... 41
`Wendell v. GlaxoSmithKline LLC, 858 F.3d 1227 (9th Cir.
`2017) ............................................................................... 43, 44, 45, 47, 56, 57
`Wyeth v. Levine, 555 U.S. 555 (2009) ......................................................... 32, 33, 34
`Xavier v. Philip Morris USA Inc., 787 F. Supp. 2d 1075 (N.D. Cal.
`2011) .............................................................................................................. 71
`DOCKETED CASES
`Messick v. Novartis Pharmaceuticals Corp., No. 13-15433 (9th Cir.),
`Dkt. 19-1 ........................................................................................................ 45
`Wendell v. GlaxoSmithKline LLC, No. 14-16321 (9th Cir.), Dkt. 11 ................ 44, 45
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`CONSTITUTIONS, STATUTES, RULES, AND REGULATIONS
`U.S. Constitution
`art. VI, cl. 2 .................................................................................................... 24
`amend. XIV, § 1 ......................................................................................... 4, 80
`7 U.S.C.
`§136 et seq. .................................................................................................. 3, 5
`§136 .....................................................................................5, 6, 10, 25, 27, 28
`§136a .............................................................................................. 5, 25, 27, 35
`§136j .............................................................................................. 6, 25, 27, 29
`§136k ............................................................................................................. 28
`§136l ........................................................................................................ 25, 28
`§136v ......................................................................................................passim
`28 U.S.C.
`§1291 ............................................................................................................... 3
`§1332 ............................................................................................................... 3
`Fed. R. Evid.
`Rule 403 .................................................................................19, 23, 64, 65, 68
`Rule 702 ......................................................................................................... 13
`Cal. Civ. Code §3294 ..................................................................................... 4, 77, 85
`Cal. Civ. Jury Instruction 430 ............................................................................ 71, 72
`Cal. Code Regs. tit. 27, §25306 ................................................................................. 9
`Cal. Health & Safety Code
`§25249.6 .......................................................................................................... 9
`§25249.8 .......................................................................................................... 9
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`40 C.F.R.
`§152.15 ............................................................................................................ 6
`§152.20 .......................................................................................................... 27
`§152.44 ........................................................................................ 10, 25, 27, 37
`§152.46 .............................................................................................. 25, 27, 37
`§152.50 .......................................................................................................... 37
`§156.10 .......................................................................................................... 27
`§156.60 .......................................................................................................... 27
`§158.200 ........................................................................................................ 27
`§158.500 .......................................................................................................... 5
`OTHER AUTHORITIES
`EPA, Glyphosate: Proposed Interim Registration Review Decision,
`Docket EPA-HQ-OPP-2009-0361-2344 (Apr. 2019),
`https://tinyurl.com/y6h2u8w6 ...................................................................... 6, 9
`EPA, Office of Pesticide Programs, Pesticide Registration Notice 98-
`10 (Oct. 22, 1998), https://tinyurl.com/yejwzhkt .......................................... 37
`EPA, Revised Glyphosate Issue Paper (Dec. 12, 2017),
`https://www.regulations.gov/document?D=EPA-HQ-OPP-
`2009-0361-0073 ........................................................................................... 6, 8
`Letter from Michael L. Goodis, EPA, Office of Pesticide Programs
`(Aug. 7, 2019), https://tinyurl.com/y552m94m ................................ 10, 30, 35
`Lymphoma Research Foundation, About Lymphoma, Diffuse Large
`B-Cell Lymphoma, https://tinyurl.com/uos6u7p (last visited
`Dec. 13, 2019) ................................................................................................ 46
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`
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`INTRODUCTION
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`This is the first federal appeal involving a challenge to the label for Roundup
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`products, an herbicide manufactured by Monsanto. About 5,000 cases have been
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`filed in federal court alleging that Monsanto failed to warn of the risk that
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`Roundup causes non-Hodgkin’s lymphoma, a cancer that affects white blood cells.
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`This appeal has the potential to shape how every subsequent Roundup case is
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`litigated.
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`The key ingredient in Roundup is glyphosate. Glyphosate “more closely
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`approximates to a perfect herbicide than any other” because it is highly effective
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`and “environmentally benign.” ER1835-1836. Glyphosate is “a precious
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`herbicide resource for world agriculture” and “the most important herbicide of
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`th[e] [postwar] period.” ER1835.
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`Glyphosate has been repeatedly approved for sale by the Environmental
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`Protection Agency (“EPA”), which—along with other regulatory agencies
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`worldwide—has consistently concluded that glyphosate does not cause cancer in
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`humans. Indeed, earlier this year, EPA announced that including a cancer warning
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`on a glyphosate-based product would constitute misbranding in violation of federal
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`law. Against this consensus, a working group at the International Agency for
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`Research on Cancer (“IARC”) in 2015 classified glyphosate as “probably
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`carcinogenic to humans.” IARC did not identify either the circumstances under
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`
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`which glyphosate might cause cancer or the amount of exposure required. Many
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`regulatory agencies, including EPA, reviewed and rejected its conclusion. Still,
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`based on that slender reed, thousands of litigants filed suit asserting that Monsanto
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`had failed to warn them about the cancer risks of using Roundup.
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`Plaintiff Edwin Hardeman alleges that Monsanto is liable for failing to warn
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`that exposure to Roundup could cause non-Hodgkin’s lymphoma.
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`Notwithstanding that federal law prohibited Monsanto from warning that Roundup
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`is carcinogenic, the district court allowed Hardeman to present his failure-to-warn
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`claims to a jury. The court then made a series of critical evidentiary errors,
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`beginning with its failure to exclude expert testimony on causation, despite
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`recognizing that the evidence was feeble and likely inadmissible in other Circuits.
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`The court then exacerbated that error by allowing Hardeman to emphasize IARC’s
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`conclusion without allowing Monsanto to show the jury that regulatory agencies
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`worldwide have rejected it, and then by instructing the jury on a causation theory
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`that California courts would not have allowed and that even Hardeman repudiated.
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`As a consequence of those errors, the jury returned a massive verdict against
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`Monsanto, including (even after reduction) quadruple punitive damages.
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`That verdict defies both expert regulatory judgment and sound science. This
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`Court should reverse, and make clear that a manufacturer cannot be forced by state
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`law to add a warning to its products that federal law would deem illegal; that
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`
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`expert testimony dependent on fundamental methodological flaws cannot be
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`sufficient to take such a speculative case to a jury; and that a manufacturer cannot
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`be punished for doing something that was perfectly legal both at the time and
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`now—marketing without a cancer warning a product that regulators and reliable
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`scientific studies have deemed non-carcinogenic.
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`JURISDICTION
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`
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`The district court had jurisdiction under 28 U.S.C. §1332 because Monsanto
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`and Hardeman are residents of different states and the amount in controversy
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`exceeds $75,000. ER2280. The district court entered final judgment on July 17,
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`2019, and Monsanto filed a timely notice of appeal on August 15, 2019. ER1-2,
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`125-126. This Court has jurisdiction under 28 U.S.C. §1291.
`
`ISSUES ON APPEAL
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`1. Whether Hardeman’s claims are preempted under the Federal
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`Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. §136 et seq.
`
`2. Whether the district court misinterpreted the Daubert standard, which
`
`caused it to admit unreliable expert testimony purporting to link glyphosate to
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`Hardeman’s non-Hodgkin’s lymphoma.
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`3. Whether the district court erred by admitting IARC’s conclusion
`
`about the carcinogenicity of glyphosate and excluding evidence that numerous
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`regulatory bodies have rejected IARC’s conclusion.
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`4. Whether the district court erred by instructing the jury that it could
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`find for Hardeman if it believed that Hardeman’s cancer was independently caused
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`by both Roundup and by another factor, even though Hardeman argued that
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`Roundup was the sole factor.
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`5. Whether the district court should have granted judgment as a matter of
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`law, because the alleged carcinogenic risk of glyphosate was not known or
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`knowable under the generally recognized and prevailing best scientific and medical
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`knowledge at the time of Hardeman’s exposure.
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`
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`6. Whether the jury’s award of punitive damages violates California
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`Civil Code §3294 or the Due Process Clause of the Fourteenth Amendment.
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`CONSTITUTIONAL AND STATUTORY PROVISIONS INVOLVED
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`Relevant provisions of the U.S. Constitution, FIFRA, and California Civil
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`Code §3294 are in the addendum.
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`
`
`STATEMENT
`A. Glyphosate’s Longstanding Record Of Regulatory Approvals And
`Findings Of Non-Carcinogenicity
`1.
`
`EPA approves glyphosate for sale and determines that it is
`not carcinogenic1
`
`a.
`
`The Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”)
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`requires EPA to regulate “the use, sale[,] … and labeling of pesticides.” Bates v.
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`Dow Agrosciences LLC, 544 U.S. 431, 437 (2005); see 7 U.S.C. §136 et seq.
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`FIFRA is a “comprehensive regulatory statute.” Ruckelshaus v. Monsanto Co.,
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`467 U.S. 986, 991 (1984). For EPA to register a pesticide for sale in the United
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`States, EPA must “determine that the pesticide will not cause ‘unreasonable
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`adverse effects on the environment,’” id. at 992 (quoting 7 U.S.C. §136a(c)(5)(C)),
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`which is defined to include an unreasonable adverse effect on human health, 7
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`U.S.C. §136(bb). EPA makes registration determinations only after considering
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`voluminous scientific data, 7 U.S.C. §§136a(c)(1)(F), (c)(2(A); 40 C.F.R.
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`§158.500, and FIFRA requires EPA to re-review a pesticide’s registration,
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`including its effects on human health, every fifteen years, 7 U.S.C. §136a(g). As
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`1 Because glyphosate is Roundup’s active ingredient, this brief treats the
`terms “Roundup” and “glyphosate” as synonymous. Although Hardeman briefly
`suggested at trial that there was a meaningful difference between the two
`substances, the district court found that the evidence supporting this position was
`“exceedingly thin.” ER128. Accordingly, nothing in this brief turns on that
`distinction.
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`Case: 19-16636, 12/13/2019, ID: 11532491, DktEntry: 27, Page 18 of 105
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`part of the registration process, EPA must approve a pesticide’s label, which the
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`manufacturer then must use without modification. Id. §136j(a)(1)(E). A state may
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`“not impose or continue in effect any requirements for labeling or packaging in
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`addition to or different from those” required by EPA. Id. §136v(b).
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`b.
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`Starting in 1974, EPA has registered pesticides containing glyphosate,
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`reflecting the agency’s conclusion that glyphosate did not have an unreasonable
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`adverse effect on human health. See EPA, Glyphosate: Proposed Interim
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`Registration Review Decision 4 (Apr. 2019), https://tinyurl.com/y6h2u8w6
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`(“PID”).2 Since then, EPA has repeatedly approved the use of glyphosate as a
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`pesticide, each time concluding that it is not likely to be carcinogenic to humans.
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`EPA has evaluated whether glyphosate is carcinogenic on multiple
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`occasions. See EPA, Revised Glyphosate Issue Paper (Dec. 12, 2017), excerpts at
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`ER1852-1861 (full document at https://tinyurl.com/eparevdglyphosate). In the
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`early 1990s, EPA conducted a robust re-evaluation of glyphosate’s effects on
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`human health as part of its regular review of glyphosate’s registration. See
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`ER1844. EPA considered numerous carcinogenicity studies in rats and mice, none
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`of which showed “convincing evidence” that glyphosate was a carcinogen.
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`ER1845. On that basis, the agency “classified glyphosate as a Group E
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`2 FIFRA treats herbicides, which target unwanted vegetation, as pesticides
`that must be registered with the EPA. 7 U.S.C. §136(t), (u); 40 C.F.R. §152.15.
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`Case: 19-16636, 12/13/2019, ID: 11532491, DktEntry: 27, Page 19 of 105
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`carcinogen”—signifying “evidence of non-carcinogenicity in humans.” ER1844.
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`Over the subsequent years, EPA repeatedly reaffirmed its conclusion that
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`glyphosate is not carcinogenic. See, e.g., ER1848 (“Data indicate that glyphosate
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`is a group E carcinogen ([i.e.,] evidence of noncarcinogenicity for studies in
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`humans …)”), ER1851 (“Glyphosate has no carcinogenic potential.”); see also
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`Monsanto Mot. for Summ. J., No. 3:16-md-02741, Dkt. 2419 at 12-13 (identifying
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`numerous instances where EPA has taken the position that glyphosate is non-
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`carcinogenic).
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`2.
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`IARC’s incomplete finding
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`In 2015, a working group at IARC, an agency of the World Health
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`Organization, issued a report classifying glyphosate as a “Group 2A” agent,
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`meaning it is “probably carcinogenic to humans,” based on glyphosate’s “limited”
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`evidence of cancer in humans and “sufficient” evidence of cancer in experimental
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`animals. ER1819 (emphasis omitted). IARC classifies 82 agents under group 2A,
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`including very hot beverages, shift work, and red meat. See Monsanto Mot. to
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`Dismiss, No. 3:16-cv-00525, Dkt. 18 at 4-5 (collecting IARC reports).
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`IARC’s classification is only a “hazard identification,” which is merely the
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`first step of an overall public health assessment designed to “identify cancer
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`hazards even when risks are very low at current exposure levels.” ER58. That
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`hazard determination asks whether glyphosate “is capable of causing cancer under
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`Case: 19-16636, 12/13/2019, ID: 11532491, DktEntry: 27, Page 20 of 105
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`some circumstances,” but a public health assessment requires a second necessary
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`step—an actual “risk assessment” which gauges the carcinogenic effects from real-
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`world human exposure.