Case: 20-16758, 02/12/2021, ID: 12002779, DktEntry: 18, Page 1 of 95
`
`No. 20-16758
`
`
`
`_________________________________________________
`IN THE UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`_________________________________________________
`XAVIER BECERRA, ATTORNEY GENERAL OF CALIFORNIA, et al.,
`Defendants/Appellants,
`v.
`
`
`
`NATIONAL ASSOCIATION OF WHEAT GROWERS, et al.,
`Plaintiffs/Appellees.
`_________________________________________________
`
`On Appeal from the United States District Court
`for the Eastern District of California
`Nos. 2:17-cv-02401-WBS-EFB
`(Hon. William B. Shubb)
`_________________________________________________
`OPENING BRIEF OF APPELLANT XAVIER
`BECERRA, ATTORNEY GENERAL OF THE STATE
`OF CALIFORNIA
`_________________________________________________
`
`
`ANDREW J. WIENER
`LAURA J. ZUCKERMAN
`Deputy Attorneys General
`State Bar No. 161896
`1515 Clay Street, 20th Floor
`Oakland, CA 94612-0550
`Telephone: (510) 879-1299
`Fax: (510) 622-2270
`Email:
`Laura.Zuckerman@doj.ca.gov
`
`
`Attorneys for Defendant and
`Appellant Xavier Becerra,
`Attorney General of the State of
`California
`
`
`XAVIER BECERRA
`Attorney General of the State of
`California
`DAVID A. ZONANA
`Acting Senior Assistant Attorney
`General
`DENNIS A. RAGEN
`Acting Supervising Deputy
`Attorney General
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`Case: 20-16758, 02/12/2021, ID: 12002779, DktEntry: 18, Page 2 of 95
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`TABLE OF CONTENTS
`
`
`Page
`
`
`INTRODUCTION ......................................................................................... 1
`JURISDICTIONAL STATEMENT .............................................................. 5
`STATEMENT OF ISSUE PRESENTED ...................................................... 5
`STATEMENT OF THE CASE ..................................................................... 6
`STATUTORY AND REGULATORY BACKGROUND .......................... 6
`I.
`A.
`The Listing Mechanisms ................................................. 8
`B.
`The Warning Requirement............................................ 11
`1.
`The “Safe Harbor” No Significant Risk
`Level ................................................................... 12
`2. Warning Language ............................................. 13
`3.
`Proposition 65 Enforcement ............................... 16
`FACTUAL BACKGROUND .......................................................... 17
`A.
`The International Agency for Research on Cancer ...... 17
`B.
`Reliance on IARC by U.S. Federal and State
`Government Entities ..................................................... 19
`IARC’s 2015 Classification of Glyphosate as a
`Carcinogen .................................................................... 22
`D. OEHHA’s Placement of Glyphosate on the
`Proposition 65 List. ....................................................... 24
`OEHHA’s Establishment of a No Significant Risk
`Level for Glyphosate. ................................................... 25
`There Is No Evidence in the Record that
`Glyphosate Warnings Would Be Required for
`Food Products. .............................................................. 27
`EPA’s and Other Regulatory Agencies’
`Conclusions ................................................................... 28
`Recent Court Rulings and Jury Verdicts ...................... 35
`
`II.
`
`C.
`
`E.
`
`F.
`
`G.
`
`H.
`
`
`
`i
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`III. PROCEDURAL HISTORY ............................................................ 39
`A.
`Preliminary Injunction .................................................. 39
`B.
`Summary Judgment ...................................................... 40
`SUMMARY OF ARGUMENT ................................................................... 43
`STANDARD OF REVIEW ......................................................................... 45
`ARGUMENT ............................................................................................... 46
`DISCLOSURE REQUIREMENTS FOR COMMERCIAL SPEAKERS
`I.
`ARE SUBJECT TO REDUCED SCRUTINY UNDER THE FIRST
`AMENDMENT. ........................................................................... 47
`II. A GLYPHOSATE WARNING REQUIRED BY PROPOSITION 65
`CAN COMPLY WITH THE FIRST AMENDMENT. .......................... 48
`A.
`The Attorney General’s Proposed Warning for
`Glyphosate Complies with Zauderer and CTIA II. ...... 51
`1.
`The Warning is Purely Factual. .......................... 54
`2.
`The Warning Is Uncontroversial. ....................... 58
`3.
`The Warning Is Not Misleading. ........................ 61
`4.
`The Warning Is Reasonably Related to the
`State’s Substantial Interest in Protecting
`Public Health and Safety. ................................... 67
`The Warning Is Neither Unjustified Nor
`Unduly Burdensome. .......................................... 70
`The Proposed Warning in this Case Also Complies
`with Central Hudson. .................................................... 74
`CONCLUSION ............................................................................................ 77
`STATEMENT OF RELATED CASES ....................................................... 79
`CERTIFICATE OF COMPLIANCE ........................................................... 80
`STATUTORY ADDENDUM ..................................................................... 81
`
`B.
`
`5.
`
`
`
`ii
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`
`TABLE OF AUTHORITIES
`
`
`Page
`
`
`CASES
`AFL-CIO v. Deukmejian
`212 Cal. App. 3d 425 (Cal. Ct. App. 1989) ............................... 6, 9, 10, 11
`Am. Chemistry Council v. Office of Environmental Health
`Hazard Assessment
`55 Cal. App. 5th 1113 (Cal. Ct. App. 2020) ........................................ 9, 30
`Am. Meat Inst. v. U.S. Dep’t of Agric.
`760 F.3d (D.C. Cir. 2014) ........................................................................ 75
`American Beverage Ass’n v. City & County of San Francisco
`916 F.3d 749 (9th Cir. 2019) (en banc) ................................. 48, 51, 71, 75
`Arizonans for Official English v. Arizona
`520 U.S. 43 (1997)................................................................................... 46
`Baxter Healthcare Corp. v. Denton
`120 Cal. App. 4th 333 (2004) .................................................................. 16
`Bd. of Trs. of State Univ. of N.Y. v. Fox
`492 U.S. 469 (1989)........................................................................... 47, 75
`Central Hudson Gas & Electric Corp. v. Public Service
`Commission of New York
`447 U.S. 557 (1980).......................................................................... passim
`CTIA-The Wireless Ass’n v. City of Berkeley
`928 F.3d 832 (9th Cir. 2019), (CTIA II) ........................................... passim
`Def. of Wildlife v. Zinke
`856 F.3d 1248 (9th Cir. 2017) ................................................................. 45
`Dowhal v. SmithKline-Beecham Consumer Healthcare
`32 Cal. 4th 910 (Cal. 2004) ..................................................................... 13
`
`
`
`iii
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`Ellis v. Bhd. of Ry., Airline & S.S. Clerks, Freight Handlers,
`Exp. & Station Employees
`466 U.S. 435 (1984)................................................................................. 46
`Environmental Law Found. v. Wykle Research, Inc.
`134 Cal. App. 4th 60 (Cal. Ct. App. 2005) .............................................. 13
`ExxonMobil Corp. v. OEHHA
`169 Cal. App. 4th 1264 (Cal. Ct. App. 2009) .......................................... 54
`Hardeman v. Monsanto Co.
`Ninth Circuit Case No. 19-16253 ............................................................ 37
`In Re Roundup Prods. Liab. Litig. (Hardeman v. Monsanto Co.)
`385 F. Supp. 3d 1042 (N.D. Cal. 2019) ....................................... 35, 37, 38
`In re Roundup Products Liability Litigation
`390 F. Supp. 3d 1102 (N.D. Cal. 2018) ................................................... 30
`Ingredient Communication Council v. Lungren
`2 Cal. App. 4th 1480 (Cal. Ct. App. 1992) ........................................ 12, 14
`Johnson v. Monsanto Company
`52 Cal. App. 5th 434 (Cal. Ct. App. 2020) ...................... 18, 35, 36, 39, 64
`L. F. v. Lake Wash. Sch. Dist.
`#414, 947 F.3d 621 (9th Cir. 2020) ......................................................... 45
`Legislature v. Deukmejian
`34 Cal. 3d 658 (Cal. 1983) .........................................................................7
`Lorillard Tobacco Co. v. Reilly
`533 U.S. 525 (2001)................................................................................. 74
`
`Monsanto Company v. Office of Environmental Health Hazard
`Assessment
`22 Cal. App. 5th 534 (Cal. Ct. App. 2018) ....................................... passim
`Nat’l Elec. Mfrs. Ass’n v. Sorrell
`272 F.3d 104 (2d Cir. 2001) .............................................................. 59, 68
`
`
`
`iv
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`TABLE OF AUTHORITIES
`(continued)
`
`Page
`
`
`National Institute of Family and Life Advocates v. Becerra
`138 S. Ct. 2361 (2018) ...................................................................... passim
`Styrene Information & Research Center v. Office of
`Environmental Health Hazard Assessment
`210 Cal. App. 4th 1082 (Cal. Ct. App. 2012) .................................... 11, 19
`Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer
`Council, Inc.
`425 U.S. 748 (1976)............................................................................. 3, 67
`Western Crop Protection Ass’n v. Davis
`80 Cal. App. 4th 741 (Cal. Ct. App. 2000) .................................................9
`Zauderer v. Office of Disciplinary Counsel of Supreme Court of
`Ohio
`471 U.S. 626 (1985).......................................................................... passim
`CONSTITUTIONAL PROVISIONS
`First Amendment ................................................................................... passim
`FEDERAL STATUTES
`15 U.S.C. § 2601 et seq. ............................................................................... 20
`28 U.S.C.
`
`§ 1291 .........................................................................................................5
`
`§ 1331 .........................................................................................................5
`
`FEDERAL REGULATIONS
`
`29 C.F.R. § 1910.1200, Appendix D ...................................................... 21, 65
`40 C.F.R. § 707.60(c)(2)(ii) .......................................................................... 20
`
`
`
`v
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`

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`50 Fed. Reg. 10375 (Mar. 14, 1985) ............................................................ 10
`80 Fed. Reg. 40,138 (July 13, 2015) ................................................................1
`CALIFORNIA STATUTES
`
`Cal. Educ. Code
`
`§ 32062(a) ................................................................................................ 20
`
`§ 32062(b) ................................................................................................ 20
`
`Cal. Health & Safety Code
`
`§ 25249.6 ..................................................................................... 11, 13, 14
`
`§ 25249.10(b) ........................................................................................... 12
`
`§ 25249.7(c) ............................................................................................. 16
`
`§ 25249.7(d) ............................................................................................. 16
`
`§ 25249.7(d)(1) .................................................................................. 16, 17
`
`§ 25249.7(e)(1)(A) ................................................................................... 17
`
`§ 25249.8 ................................................................................................. 54
`
`§ 25249.8(a) ...................................................................................... passim
`
`§ 25249.8(b) ......................................................................................... 9, 10
`
`§ 25249.10(c) ............................................................................... 12, 13, 70
`
`§ 25249.12(a) ..............................................................................................6
`
`§ 111791.5(b)(2) ...................................................................................... 20
`
`Cal. Lab. Code
`
`§ 6382(b)(1) ....................................................................................... 7, 8, 9
`
`§ 6382(d) .....................................................................................................7
`
`Cal. Penal Code
`
`§ 374.8(c)(2)(D) ....................................................................................... 20
`
`CALIFORNIA CODE OF REGULATIONS
`
`Title 27
`
`§ 25306(m) ............................................................................................... 11
`
`§ 25601 .................................................................................................... 14
`
`§ 25601(c) ................................................................................................ 72
`
`§ 25601(e) ................................................................................................ 50
`
`§§ 25601-25607.33 .................................................................................. 13
`vi
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`TABLE OF AUTHORITIES
`(continued)
`
`Page
`
`
`Title 27 (continued)
`
`§ 25603 .................................................................................................... 14
`
`§ 25603(a)(2)(B) ...................................................................................... 49
`
`§ 25603(d) ................................................................................................ 50
`
`§ 25605 .................................................................................................... 14
`
`§ 25606 ........................................................................................ 21, 65, 70
`
`§ 25607.2 ................................................................................................. 14
`
`§ 25607.4 ................................................................................................. 14
`
`§ 25607.6 ................................................................................................. 14
`
`§ 25607.9 ................................................................................................. 14
`
`§ 25607.11 ............................................................................................... 14
`
`§ 25607.13 ............................................................................................... 14
`
`§ 25607.15 ............................................................................................... 14
`
`§ 25607.17 ............................................................................................... 14
`
`§ 25607.19 ............................................................................................... 14
`
`§ 25607.21 ............................................................................................... 14
`
`§ 25607.23 ............................................................................................... 14
`
`§ 25607.25 ............................................................................................... 14
`
`§ 25607.27 ............................................................................................... 14
`
`§ 25607.29 ............................................................................................... 14
`
`§ 25607.33 ............................................................................................... 14
`
`§ 25703(a) ................................................................................................ 27
`
`§ 25703(b) ................................................................................................ 12
`
`§ 25704 .................................................................................................... 22
`
`§ 25705 .............................................................................................. 12, 25
`
`§ 25904(b)(2) ........................................................................................... 11
`
`§ 25904(b) (3) .......................................................................................... 11
`
`
`
`
`
`
`vii
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`
`
`INTRODUCTION
`Nearly thirty-five years ago, Californians voted overwhelmingly for
`
`Proposition 65, a groundbreaking initiative that requires businesses to warn
`
`individuals when they expose them to chemicals identified as carcinogens by
`
`certain expert agencies, including the International Agency for Research on
`
`Cancer (IARC), “a recognized international authority on the carcinogenic
`
`potential of chemicals and other agents[.]” 80 Fed. Reg. 40,138, 40,424
`
`(July 13, 2015). This case challenges Proposition 65’s ability to mandate
`
`such warnings for the chemical glyphosate, the active ingredient in
`
`Monsanto Company’s popular herbicide, Roundup.1
`
`IARC identified glyphosate as a carcinogen in 2015. In response to this
`
`identification, California’s Office of Environmental Health Hazard
`
`Assessment (OEHHA), the lead agency for Proposition 65, placed
`
`glyphosate on the State’s list of carcinogens in 2017, a listing that survived a
`
`constitutional challenge and, notwithstanding Monsanto’s documented
`
`efforts to discredit IARC, was upheld by a California court of appeal in
`
`
`1 An herbicide is a category of pesticide used primarily for weed
`control. See, e.g., https://www.epa.gov/ingredients-used-pesticide-
`products/types-pesticide-ingredients. The terms “herbicide” and “pesticide”
`will be used interchangeably throughout this brief to describe Roundup and
`other glyphosate-based herbicides.
`
`1
`
`

`

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`2018. As a result of the listing, Proposition 65 requires businesses whose
`
`products expose Californians to high levels of glyphosate to provide a clear
`
`and reasonable warning that the chemical is a carcinogen.
`
`Plaintiffs and Appellees Monsanto and a consortium of agricultural
`
`associations and business groups argued to the district court that any
`
`compelled disclosure of IARC’s carcinogenicity determination would violate
`
`their First Amendment rights because several other organizations, including
`
`the United States Environmental Protection Agency (EPA), have stated that
`
`glyphosate is not a carcinogen. In effect, plaintiffs argued below that the
`
`First Amendment empowered them to expose consumers and workers even
`
`to high levels of glyphosate without warning them that IARC has found
`
`glyphosate to be a carcinogen – information those individuals could have
`
`used to protect themselves from exposure. This position is unfounded, and
`
`the district court erred by adopting it.
`
`The purpose of First Amendment protection for commercial speech is
`
`to ensure that consumers have information to enable informed decisions in
`
`the marketplace. See Zauderer v. Office of Disciplinary Counsel of Supreme
`
`Court of Ohio, 471 U.S. 626, 651 (1985) (noting that First Amendment
`
`protection for commercial speech is “justified principally by the value to
`
`
`
`2
`
`

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`
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`consumers of the information such speech provides”); see also Virginia
`
`State Bd. of Pharmacy v. Virginia Citizens Consumer Council, Inc., 425 U.S.
`
`748, 756 (1976) (freedom of speech necessarily protects the right to receive
`
`information and ideas).
`
`Here, an expert scientific agency has determined that glyphosate is a
`
`carcinogen. This is information that consumers, workers, and commercial
`
`users might well find useful when deciding whether to use glyphosate-based
`
`herbicides, and, if so, how to safeguard their health when using them.
`
`Nothing in the First Amendment or this Court’s precedents requires a
`
`consensus of scientific judgment – which may take decades to develop –
`
`before the State may require a business to provide that vital information to
`
`those being exposed to glyphosate.
`
`Under this Court’s controlling decision in CTIA-The Wireless Ass’n v.
`
`City of Berkeley, 928 F.3d 832 (9th Cir. 2019), cert. denied, 140 S. Ct. 658
`
`(2019) (CTIA II), Proposition 65’s warning requirement for glyphosate is
`
`clearly constitutional. The district court’s conclusion that there could be no
`
`warning that complied with the statute and with the First Amendment, which
`
`led the court to enjoin all enforcement, was in error. Defendant and
`
`Appellant Xavier Becerra, the Attorney General of California (Attorney
`
`General), has proposed one such warning: a detailed, purely factual, and
`3
`
`

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`uncontroversial statement providing information about both IARC’s
`
`determination and EPA’s finding, a warning that is neither unjustified nor
`
`unduly burdensome, and that serves a substantial state interest. The
`
`Attorney General’s proposed warning not only complies with Supreme
`
`Court and Ninth Circuit case law, but also advances one of the core purposes
`
`of the First Amendment, as well as of Proposition 65 – to foster the
`
`dissemination of accurate information that, in this case, serves to protect
`
`public health and safety.
`
`Because the Attorney General’s proposed Proposition 65 warning
`
`complies with the First Amendment, the Attorney General respectfully
`
`requests that the Court reverse the district court’s order, vacate the judgment,
`
`and instruct the district court to enter judgment for the Attorney General.
`
`
`
`4
`
`

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`
`
`JURISDICTIONAL STATEMENT
`The district court had jurisdiction pursuant to 28 U.S.C. § 1331 (action
`
`arising under the United States Constitution).
`
`On June 22, 2020, the district court granted the Plaintiffs’ motion for
`
`summary judgment, and denied the Attorney General’s cross-motion for
`
`summary judgment. 1-ER-4 at 36-37. The district court entered a final
`
`judgment disposing of the claims of all parties in the case on August 11,
`
`2020. 1-ER-1. On September 9, 2020, the Attorney General timely
`
`appealed. 11-ER-2356.
`
`This Court has appellate jurisdiction pursuant to 28 U.S.C. § 1291.
`
`STATEMENT OF ISSUE PRESENTED
`Whether, in the absence of scientific consensus, the First Amendment
`
`prohibits California’s Proposition 65 from requiring a business to warn
`
`Californians before it exposes them to significant amounts of glyphosate, a
`
`chemical that the International Agency for Research on Cancer, a worldwide
`
`leader in cancer research, has determined causes cancer in animals and is
`
`probably carcinogenic to humans.
`
`STATUTORY ADDENDUM
`Pertinent statutes and regulations are set forth in an addendum to this
`
`brief.
`
`5
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`

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`STATEMENT OF THE CASE
`In this section, the Attorney General provides the statutory and
`
`regulatory background underlying this case, the facts necessary to decide the
`
`question presented, and the case’s procedural history.
`
`I.
`
`STATUTORY AND REGULATORY BACKGROUND
`The Safe Drinking Water and Toxic Enforcement Act, better known as
`
`Proposition 65, was enacted by initiative in 1986. The law requires the
`
`Governor of California to publish a “list of those chemicals known to the
`
`state to cause cancer or reproductive toxicity within the meaning of this
`
`chapter.”2 Cal. Health & Safety Code § 25249.8(a). It requires businesses
`
`to give warnings before exposing people to these chemicals.
`
`Proposition 65 passed in response to voters’ concerns that “‘hazardous
`
`chemicals pose a serious potential threat to their health and well-being, [and]
`
`that state government agencies have failed to provide them with adequate
`
`protection . . . .’” AFL-CIO v. Deukmejian, 212 Cal. App. 3d 425, 430 (Cal.
`
`Ct. App. 1989) (quoting the Ballot Pamphlet for Proposition 65)
`
`(Deukmejian). Perhaps anticipating efforts by industry to influence
`
`
`2 The publication of the Proposition 65 list has been delegated by the
`Governor to the Office of Environmental Health Hazard Assessment
`(OEHHA), the current lead agency for implementation of the statute. See
`Cal. Health & Safety Code § 25249.12(a).
`6
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`
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`

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`
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`government regulators, Proposition 65 spells out certain explicit
`
`requirements. One is that businesses must inform people when they expose
`
`them to chemicals that have been identified by certain expert organizations –
`
`including IARC – as causing cancer. Cal. Health & Safety Code §
`
`25249.8(a); Cal. Lab. Code §§ 6382(b)(1), (d). The proponents made this
`
`explicit in the ballot pamphlet:
`
`At a minimum, the Governor must include [in the Proposition 65
`list] the chemicals already listed as known carcinogens by two
`organizations of the most highly regarded national and
`international scientists: the U.S.’s National Toxicology Program
`and the U.N.’s International Agency for Research on Cancer.
`(Emphasis added.)3
`The voters could not have been more clear. They wanted to be warned
`
`about exposures to chemicals that IARC had classified as carcinogens,
`
`“regardless of whether other identified listing agencies or processes
`
`agree.” Monsanto v. Office of Environmental Health Hazard Assessment, 22
`
`Cal. App. 5th 534, 559 (Cal. Ct. App. 2018) (emphasis added) (Monsanto v.
`
`OEHHA). They did not require scientific agreement or consensus.
`
`While the statute has been subject to criticism, it has had major
`
`successes over the years, and has been highly effective in providing
`
`
`3 2-ER-118; Legislature v. Deukmejian, 34 Cal. 3d 658, 673 (Cal.
`1983) (“Ballot summaries and arguments may be considered when
`determining the voters’ intent and understanding of a ballot measure.”).
`7
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`

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`information to consumers and in encouraging businesses to remove toxic
`
`chemicals from their products so that they do not need to provide a warning.
`
`These successes have included reducing high levels of lead and other
`
`hazardous substances in an array of products, including candy, children’s
`
`jewelry, soda bottles, children’s toys, artificial turf, dietary supplements,
`
`hair-straightening products, and children’s bedding, as well as emissions of
`
`cancer-causing chemicals from chrome plating and asphalt roofing
`
`operations.4
`
`A. The Listing Mechanisms
`Proposition 65 provides four separate mechanisms for listing
`
`chemicals. Cal. Health & Safety Code §§ 25249.8(a), (b). Under the listing
`
`mechanism applicable here, the “Labor Code listing mechanism” of
`
`California Health and Safety Code section 25249.8(a), OEHHA is required
`
`to list “at a minimum those substances identified by reference in [California]
`
`Labor Code section 6382(b)(1),” which identifies “[s]ubstances listed as
`
`
`4 2-ER-125 (Mexican-style candy), 2-ER-185 (ginger candy), 2-ER-228
`(cola), 2-ER-316 (artificial turf), 3-ER-345 (jewelry); 3-ER-375 (toys); 3-
`ER-397 (children’s furniture); 3-ER-412 at 425 (dietary supplements); 3-
`ER-459 (hair-straightening products); 3-ER-502 (hexavalent chromium from
`plating emissions); 3-ER-520 (asphalt emissions); 3-ER-549 (diesel
`emissions).
`
`
`
`8
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`
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`human or animal carcinogens by” IARC.5 Cal. Health & Safety Code §
`
`25249.8(a) (emphasis added); Cal. Labor Code § 6382(b)(1).
`
`As the Deukmejian court explained, the relevant question for
`
`determining whether a chemical should be placed on the Proposition 65 list
`
`of carcinogens is not whether a chemical is probably carcinogenic to
`
`humans, but “whether it is in fact a known carcinogen . . . .” Deukmejian,
`
`212 Cal. App. 3d at 437. Accordingly, the list must include chemicals for
`
`which there is sufficient evidence that exposure causes cancer in animals
`
`(e.g., “known carcinogens”), even if there is insufficient evidence that it
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`causes cancer in humans. Id.; Western Crop Protection Ass’n v. Davis, 80
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`Cal. App. 4th 741, 749 (Cal. Ct. App. 2000); Am. Chemistry Council v.
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`Office of Environmental Health Hazard Assessment, 55 Cal. App. 5th 1113,
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`1142 (Cal. Ct. App. 2020).
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`The statute takes this approach for sound scientific reasons: the
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`principle of animal-to-human extrapolation in the context of carcinogenesis
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`is well-established, and has been accepted by virtually all health and
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`
`5 The other three listing mechanisms are the “authoritative body” listing
`mechanism, the “state’s qualified experts” listing mechanism, and the
`“formally required to be labeled” listing mechanism. Cal. Health & Safety
`Code § 25249.8(b).
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`9
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`Case: 20-16758, 02/12/2021, ID: 12002779, DktEntry: 18, Page 18 of 95
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`regulatory agencies. See Deukmejian, 212 Cal. App. 3d at 438 n.7 (citing
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`Report, Office of Science and Technology Policy, 50 Fed. Reg. 10375 (Mar.
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`14, 1985)). “It is unethical to test humans, and because of the 20-30 year
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`latency period of many human cancers, epidemiological studies6 do not
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`adequately warn humans and protect them from the risk of exposure to new
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`carcinogens.” Id. Indeed, “for recognized human carcinogens, the first
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`evidence of carcinogenicity frequently is found in test animals; only
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`afterwards are cancer effects looked for, and found, in humans.” Id.
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`
`
`Chemicals thus are included on the list of “known” carcinogens if
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`IARC – or one of the other authoritative bodies under Proposition 657 – has
`
`
`6 “Epidemiological studies measure the risk of illness or death in an
`exposed population compared to that risk in an identical, unexposed
`population (for example, a population the same age, sex, race, and social
`status as the exposed population).” https://toxtutor.nlm.nih.gov/05-
`003.html#:~:text=Epidemiological%20studies%20measure%20the%20risk,s
`tatus%20as%20the%20exposed%20population.
`7 In addition to IARC’s statutory role under the Labor Code listing
`mechanism pursuant to which glyphosate was listed, Cal. Health & Safety
`Code section 25249.8(a), IARC has been identified in the regulations as one
`of five “authoritative bodies” for purposes of listing carcinogens under a
`different Proposition 65 listing mechanism. Cal. Health & Saf. Code §
`25249.8(b) (“a chemical is known to the state to cause cancer . . . within the
`meaning of this chapter if . . . a body considered to be authoritative by [the
`state’s qualified experts] has formally identified it as causing cancer . . .”).
`The five bodies considered to be authoritative by the “state’s qualified
`experts,” who are appointed by the Governor, are IARC, the National
`
`
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`10
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`Case: 20-16758, 02/12/2021, ID: 12002779, DktEntry: 18, Page 19 of 95
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`classified them as probable or possible human carcinogens, provided there is
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`sufficient evidence that exposure causes cancer in animals. Deukmejian,
`212 Cal. App. 3d at 437; see also Styrene Information & Research Center v.
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`Office of Environmental Health Hazard Assessment, 210 Cal. App. 4th 1082,
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`1094-95 (Cal. Ct. App. 2012) (OEHHA must list chemicals that IARC has
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`classified as probably carcinogenic to humans or possibly carcinogenic to
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`humans, but only if IARC has found “sufficient evidence of carcinogenicity
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`in experimental animals”); Cal. Code Regs. tit. 27, §§ 25904 (b)(2), (3).
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`Indeed, because IARC does not use the term “known carcinogen,” for
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`purposes of interpreting IARC monographs under California law, “sufficient
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`evidence” of carcinogenicity is considered equivalent to “known”
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`carcinogenicity. See Deukmejian, 212 Cal. App. 3d at 434 n.3.
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`B. The Warning Requirement
`A business with ten or more employees must provide a clear and
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`reasonable warning before it “knowingly and intentionally expose[s] any
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`individual [in California] to