`
`No. 20-16758
`
`
`IN THE UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`
`
`XAVIER BECERRA, IN HIS OFFICIAL CAPACITY AS ATTORNEY
`GENERAL OF THE STATE OF CALIFORNIA, ET AL.,
`
`Defendants-Appellants,
`
`v.
`
`NATIONAL ASSOCIATION OF WHEAT GROWERS, ET AL.,
`
`Plaintiffs-Appellees.
`
`
`On Appeal from the U.S. District Court for the Eastern District of
`California, No. 2:17-cv-02401-WBS-EFB (Hon. William B. Shubb)
`
`
`AMICUS BRIEF OF NATURAL RESOURCES DEFENSE COUNCIL,
`UNITED STEELWORKERS, ALLIANCE OF NURSES FOR HEALTHY
`ENVIRONMENTS, AS YOU SOW, CALIFORNIANS FOR PESTICIDE REFORM,
`CENTER FOR FOOD SAFETY, CLEAN WATER ACTION, ENVIRONMENTAL LAW
`FOUNDATION, PESTICIDE ACTION NETWORK NORTH AMERICA, AND
`SAN FRANCISCO BAY PHYSICIANS FOR SOCIAL RESPONSIBILITY
`URGING REVERSAL IN SUPPORT OF DEFENDANTS-APPELLANTS
`
`
`
`
`
`
` VIVIAN H.W. WANG
`
`
`
` AVINASH KAR (SBN 240190)
` Natural Resources Defense Council
` 40 W. 20th St.
` New York, NY 10011
` (212) 727-4477
` vwang@nrdc.org
` akar@nrdc.org
`
` Counsel for Amici
`
`
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`(cid:3)
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`(cid:3)
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`CORPORATE DISCLOSURE STATEMENT
`
`Amici Natural Resources Defense Council, United Steelworkers,
`
`Alliance of Nurses for Healthy Environments, As You Sow, Californians
`
`for Pesticide Reform, Center for Food Safety, Clean Water Action,
`
`Environmental Law Foundation, Pesticide Action Network North
`
`America, and San Francisco Bay Physicians for Social Responsibility
`
`are nonprofit corporations with no parent corporation and no
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`outstanding stock shares or other securities in the hands of the public.
`
`Amici do not have any parent, subsidiary, or affiliate that has issued
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`stock shares or other securities to the public. No publicly held
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`corporation owns any stock in amici.
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`TABLE OF CONTENTS
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`INTRODUCTION ....................................................................................... 1
`
`AMICI CURIAE’S IDENTITY AND INTEREST IN THE CASE ............ 3(cid:3)(cid:3)
`ACKGROUND .......................................................................................... 7
`
`(cid:3)B
`
`(cid:3)B
`
`(cid:3)C
`
`(cid:3)A
`
`
`I.
`
`
`A. Regulation in the context of evolving scientific knowledge ............. 7(cid:3)(cid:3)
`. Proposition 65 and glyphosate ........................................................ 10(cid:3)(cid:3)
`. District court proceedings ............................................................... 15(cid:3)(cid:3)
`RGUMENT ............................................................................................. 18
`
`Courts should be wary of constitutionalizing questions at the core
`of agencies’ scientific expertise, or deciding such questions
`unnecessarily ................................................................................... 18
`
`A.(cid:3)
`
`B.
`
`
`Scientific knowledge is constantly evolving and
`thus subject to “controversy” ................................................. 19
`
`Judicial review of the soundness of an agency’s
`scientific judgment does not fit well within a First
`Amendment framework ......................................................... 21
`
`
`
`
`II. A First Amendment “controversy” standard creates
`
`perverse incentives to manufacture scientific doubt ..................... 27
`
`III. The district court erred in discounting IARC’s
`
`conclusion as an outlier opinion ..................................................... 30
`
`
`
`
`
`
`CONCLUSION ......................................................................................... 38
`
`A. Understanding risk assessment ............................................ 31
`
`B. EPA’s findings on glyphosate do not conflict
`
`with IARC’s ............................................................................ 32
`
`i
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`TABLE OF AUTHORITIES
`
`CASES
`
`
`Amoco Oil Co. v. EPA,
`
`501 F.2d 722 (D.C. Cir. 1974) ......................................................... 23
`
`ASARCO, Inc. v. Occupational Safety & Health Admin.,
`
`746 F.2d 483 (9th Cir. 1984) ............................................................. 8
`
`Banzhaf v. FCC,
`
`405 F.2d 1082 (D.C. Cir. 1968) ......................................................... 8
`
`Cal. Chamber of Commerce v. Brown,
`
`126 Cal. Rptr. 3d. 214 (Ct. App. 2011) ..................................... 11, 19
`
`Central Hudson Gas & Electric Corp. v. Public Service
`Commission,
`
` 447 U.S. 557 (1980) ........................................................................ 17
`
`CTIA-The Wireless Ass’n v. City of Berkeley,
`
`928 F.3d 832 (9th Cir. 2019) ........................................................... 16
`
`Ethyl Corp. v. EPA,
`
`541 F.2d 1 (D.C. Cir. 1976) ............................................................... 7
`
`Grocery Mfrs. Ass’n v. Sorrell,
`
`102 F. Supp. 3d 583 (D. Vt. 2015) ..................................................... 9
`
`In re Prempro Prods. Liab. Litig.,
`
`586 F.3d 547 (8th Cir. 2009) ........................................................... 27
`
`In re: Roundup Prods. Liab. Litig.,
`
`No. 16-md-02741-VC (N.D. Cal. filed Mar. 14, 2017) .................... 29
`
`Lead Indus. Ass’n v. EPA,
`
`647 F.2d 1130 (D.C. Cir. 1980) ....................................................... 19
`
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`ii
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`League of Wilderness Defs. Blue Mountains Biodiversity
`Project v. Allen,
`
`615 F.3d 1122 (9th Cir. 2010) ......................................................... 23
`
`Medtronic, Inc. v. Lohr,
`
`518 U.S. 470 (1996) ......................................................................... 10
`
`Motor Vehicle Mfrs. Ass’n of U.S. v. State Farm
`Mut. Auto. Ins. Co.,
`
`463 U.S. 29 (1983) ........................................................................... 22
`
`N. Am. Bldg. Trades Unions v. OSHA,
`
`878 F.3d 271 (D.C. Cir. 2017) (per curiam) .............................. 20, 22
`
`Nat’l Elec. Mfrs. Ass’n v. Sorrell,
`
`272 F.3d 104 (2d Cir. 2001) ............................................................. 22
`
`Nat’l Inst. of Family & Life Advocates v. Becerra,
`
`138 S. Ct. 2361 (2018) ..................................................................... 16
`
`NRDC v. EPA,
`
`No. 20-70787 (9th Cir. filed Mar. 20, 2020) ................................... 34
`
`NRDC v. Pritzker,
`
`828 F.3d 1125 (9th Cir. 2016) ........................................................... 8
`
`N.Y. State Rest. Ass’n v. N.Y.C. Bd. of Health,
`
`556 F.3d 114 (2d Cir. 2009) ............................................................... 9
`
`People ex rel. Lungren v. Superior Court,
`
`926 P.2d 1042 (Cal. 1996) ................................................................. 4
`
`Pharm. Care Mgmt. Ass’n v. Rowe,
`
`429 F.3d 294 (1st Cir. 2005) ............................................................ 26
`
`Pub. Citizen Health Rsch. Grp. v. Tyson,
`
`796 F.2d 1479 (D.C. Cir. 1986) ....................................................... 23
`
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`iii
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`Ranchers Cattlemen Action Legal Fund United
`
`Stockgrowers of Am. v. USDA,
`
`415 F.3d 1078 (9th Cir. 2005) ......................................................... 37
`
`Rocky Mountain Farmers Union v. Corey,
`
`913 F.3d 940 (9th Cir. 2019) ........................................................... 25
`
`Rural Coal. v. EPA,
`
`No. 20-70801 (9th Cir. filed Mar. 20, 2020) ................................... 34
`
`United States v. Philip Morris USA, Inc.,
`
`449 F. Supp. 2d 1, 723 (D.D.C. 2006), vacated in part
`
`on other grounds, 566 F.3d 1095 (D.C. Cir. 2009) ......................... 28
`
`United Steelworkers of Am. v. Marshall,
`
`647 F.2d 1189 (D.C. Cir. 1980) ......................................................... 7
`
`Zauderer v. Off. of Disciplinary Couns. of the Sup. Ct. of Ohio,
`
`471 U.S. 626 (1985) ......................................................................... 16
`
`
`FEDERAL STATUTES
`
`15 U.S.C. § 78l .......................................................................................... 26
`
`15 U.S.C. § 1333........................................................................................ 26
`
`15 U.S.C. § 2605(a) ................................................................................... 32
`
`15 U.S.C. § 2605(a)(1) ............................................................................... 32
`
`15 U.S.C. § 2605(a)(3) ............................................................................... 32
`
`21 U.S.C. § 343(q)(1) ................................................................................. 26
`
`42 U.S.C. § 11023...................................................................................... 26
`
`Federal Cigarette Labeling and Advertising Act,
`
`Pub. L. No. 89-92, § 4, 79 Stat. 282 (1965) ....................................... 9
`
`iv
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`FEDERAL REGULATIONS
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`21 C.F.R. § 202.1 ....................................................................................... 25
`
`29 C.F.R. § 1910.1200 ............................................................................... 25
`
`40 C.F.R. § 26.203 ..................................................................................... 21
`
`40 C.F.R. § 26.1203 ................................................................................... 21
`
`Occupational Safety and Health Administration,
`
`Occupational Exposure to Beryllium,
`
`82 Fed. Reg. 2470 (Jan. 9, 2017) ..................................................... 11
`
`
`STATE STATUTES
`
`
`Cal. Health & Safety Code
`
`§ 25249.10 ........................................................................................ 13
`
`§ 25249.10(c) .................................................................. 10, 12, 14, 32
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`§ 25249.6 .............................................................................. 12, 13, 32
`
`§ 25249.8 .......................................................................................... 10
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`§ 25249.8(a) ...................................................................................... 11
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`§ 25249.8(a)-(b) ................................................................................ 19
`
`§ 108954 ........................................................................................... 25
`
`Cal. Labor Code
`
`§ 6382(b)(1) ...................................................................................... 11
`
`N.Y. Envtl. Conserv. Law § 33–0707 ....................................................... 26
`
`
`CALIFORNIA CODE OF REGULATIONS
`
`
`Title 27
`
`§ 25306(m)(1) ................................................................................... 11
`
`§ 25701(a) ......................................................................................... 12
`
`§ 25703 ............................................................................................. 12
`
`§ 25705 ....................................................................................... 10, 12
`
`§ 25721 ............................................................................................. 12
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`v
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`§ 25904 (b)(2) ................................................................................... 10
`§ 25904 (b)(3) ................................................................................... 10
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`
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`
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`OTHER AUTHORITIES
`
`
`ATSDR, Toxicological Profile for Glyphosate (Aug. 2020) ...................... 14
`
`Austin Bradford Hill, The Environment and Disease:
`
`Association or Causation? 58 Proc. Royal Soc’y Med.
`
`295, 300 (May 1965) ........................................................................ 20
`
`David Michaels, Doubt Is Their Product: How Industry’s
`
`Assault on Science Threatens Your Health (2008) ........................ 28
`
`EPA, Final Report of the Dec. 13-16, 2016, FIFRA SAP
`
`Meeting ...................................................................................... 35, 36
`
`EPA, Glyphosate Interim Registration Review Decision,
`
`Case Number 0178 (Jan. 2020) ................................................. 14, 34
`
`EPA, Office of Pesticide Programs, Revised Glyphosate Issue Paper:
`
`Evaluation of Carcinogenic Potential (Dec. 12, 2017) ............. 33, 35
`
`IARC, Q&A on Glyphosate (2016) ..................................................... 13, 37
`
`Mary Thornton, EPA Review Finds Flawed Tests Made By
`
`Research Firm, Wash. Post, May 13, 1983 .................................... 29
`
`Naomi Oreskes & Erik M. Conway, Merchants of Doubt:
`
`How a Handful of Scientists Obscured the Truth on
`
`Issues from Tobacco Smoke to Global Warming (2010) ................ 28
`
`Nat’l Acads. of Scis., Eng’g & Med., Nat’l Rsch. Council,
`
`Risk Assessment in the Federal Government:
`
`Managing the Process (1983) .......................................................... 31
`
`
`
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`Nat’l Acads. of Scis., Eng’g & Med., Nat’l Rsch. Council,
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`Science and Decisions: Advancing Risk Assessment
`
`(2009) ......................................................................................... 20, 21
`
`Nat’l Acads. of Scis., Eng’g & Med., Nat’l Rsch. Council,
`
`Science and Judgment in Risk Assessment (1994) ........................ 31
`
`NRDC, Petition for Listing of 18 Chemicals Pursuant
`to Authoritative Bodies Mechanism of Safe
`Drinking Water and Toxic Enforcement Act of
`1986 (July 6, 2006) ............................................................................ 4
`
`
`OEHHA, Amendment to Section 25705 No Significant
`
`Risk Level–Glyphosate (Apr. 10, 2018) .......................................... 13
`
`Patricia Cohen, Roundup Maker to Pay $10 Billion to
`
`Settle Cancer Suits, N.Y. Times, June 24, 2020 ............................ 36
`
`World Health Organization, IARC Monographs on the
`
`Evaluations of Carcinogenic Risks to Humans:
`
`Preamble (2006) ............................................................................... 11
`
`U.S. Geological Survey, Estimated Annual Agricultural
`
`Pesticide Use: Pesticide Use Maps—Glyphosate
`
`(last modified June 18, 2020) .......................................................... 36
`
`
`
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`
`
`INTRODUCTION
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`Chemical hazard evaluations are often based on evolving scientific
`
`knowledge. Epidemiological studies, for example, are complex—many
`
`diseases have long latency periods, and we are exposed to a cocktail of
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`chemicals from myriad sources in our daily lives. Industry groups have
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`leveraged the uncertainty inherent in most risk assessments to
`
`undermine laws intended to inform and protect the public. The much-
`
`delayed regulation of secondhand smoke, asbestos, and lead in gasoline
`
`are prime examples of government action lagging behind science, at
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`industry’s urging and to the detriment of our health.
`
`California’s voters passed Proposition 65—one of the nation’s most
`
`important right-to-know laws—to protect themselves from unwanted
`
`exposure to hazardous chemicals that can cause cancer or reproductive
`
`harm. The list of chemicals subject to Proposition 65’s warning
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`requirements is based on highly technical determinations by expert
`
`agencies established to evaluate such hazards. One of these groups,
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`identified in California’s regulations as an authoritative scientific body,
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`is the World Health Organization’s International Agency for Research
`
`on Cancer. That agency has classified glyphosate—the active ingredient
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`1
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`
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`in Monsanto Company’s popular weed killer, Roundup—as “probably
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`carcinogenic to humans” based on a robust synthesis of publicly
`
`available information, including published reports, peer-reviewed
`
`studies, and government data. The finding prompted California to add
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`glyphosate to the Proposition 65 list.
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`Monsanto and a consortium of agribusiness groups (collectively,
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`“Monsanto” or “Plaintiffs”) contend that the Proposition 65 warning
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`requirement compels false and misleading speech because there is not
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`yet consensus on the exposure levels at which glyphosate may cause
`
`cancer. Whether a science agency’s finding is so unsound as to be
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`counterfactual is not, however, an inquiry that should be made in a
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`First Amendment context and without a full evidentiary record.
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`Plaintiffs’ theory, if adopted, would magnify incentives for industry to
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`sponsor contrary studies and generate doubt among regulatory bodies
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`in order to undercut regulations. It would also open the doors for
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`judicial scrutiny of a wide array of regulations any time a regulated
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`entity can point to dissenting scientific views. Such a result is neither
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`wise nor constitutionally required.
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`2
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`AMICI CURIAE’S IDENTITY AND INTEREST IN THE CASE
`
`Amici represent the interests of health practitioners,
`
`environmental and labor organizations, and consumer and shareholder
`
`advocacy groups. They work to address health harms caused by
`
`exposure to toxic substances and support right-to-know laws, including
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`product labeling regulations, that enable workers and consumers to
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`better protect themselves from unwanted exposure to harmful
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`chemicals. Amici submit this brief to provide context on regulatory
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`agencies’ processes for assessing health risks and to illustrate how
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`Plaintiffs’ invitation to constitutionalize complex and technical risk-
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`assessment processes will destabilize myriad warning laws and
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`undercut states’ ability to protect health and the environment.1
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`Environmental and public health amici Natural Resources
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`Defense Council, Inc. (NRDC), Center for Food Safety, Clean Water
`
`Action, and Environmental Law Foundation are nonprofit groups that
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`have worked for decades on behalf of themselves and their nationwide
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`(cid:3)
`1 All parties have consented to the filing of this brief. This brief was not
`authored in whole or part by counsel for a party. No party or counsel for
`a party, and no person other than the amici curiae or their counsel,
`contributed money intended to fund the preparation or submission of
`this brief.
`
`3
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`
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`memberships, including members in California, to reform outdated
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`chemical-safety laws and urge federal and state agencies to act on the
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`latest science in regulating dangerous chemicals that harm health and
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`the environment. This includes reducing exposure to harmful additives
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`like flame retardants in furniture, PFAS in food packaging, and
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`phthalates in children’s toys, and strengthening our clean water laws to
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`stop pollution at its source. Amici have pushed for passage and
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`continued enforcement of labeling and disclosure requirements,
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`including Proposition 65, that empower consumers to choose products
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`that are better for their health and the environment.2
`
`Worker advocacy group United Steelworkers (USW) is an
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`international labor organization and the authorized collective
`
`bargaining representative for approximately 850,000 North American
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`workers, including a majority of unionized workers in the chemical,
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`(cid:3)
`2 See, e.g., NRDC, Petition for Listing of 18 Chemicals Pursuant to
`Authoritative Bodies Mechanism of Safe Drinking Water and Toxic
`Enforcement Act of 1986 (July 6, 2006), https://oehha.ca.gov/media/
`downloads/proposition-65/proposition-65/nrdctooehha070606.pdf
`(identifying chemicals that the National Institute for Occupational
`Safety and Health determined cause reproductive toxicity); People ex
`rel. Lungren v. Superior Court, 926 P.2d 1042 (Cal. 1996) (landmark
`Proposition 65 case led by Environmental Law Foundation).
`
`4
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`petroleum, rubber, paper, metals, mineral mining (other than coal), and
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`general manufacturing industries. USW represents approximately
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`40,000 members in California, in industries including healthcare,
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`manufacturing, education, and service. The organization’s members
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`include workers who are exposed to chemicals in products, both in the
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`workplace and in their non-work activities. USW advocates for right-to-
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`know laws, which provide workers with information to assess the
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`hazards of chemicals in consumer and other products.
`
`Healthcare professional organizations Alliance of Nurses for
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`Healthy Environments (ANHE) and San Francisco Bay Physicians for
`
`Social Responsibility (SF Bay Physicians) are nonprofit education and
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`advocacy organizations that draw on the expertise of health
`
`professionals to promote policies to protect human and environmental
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`health. ANHE is a public health organization that seeks to protect
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`people from exposure to toxins in the environment through public
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`education, partnering with nurse researchers, and working at the local,
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`state, and federal levels to establish and reform chemical safety laws.
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`ANHE is concerned about the links between chemical exposure and
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`cancers, reproductive and developmental diseases, and other chronic
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`5
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`
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`ailments like asthma, diabetes, and cardiovascular disease. SF Bay
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`Physicians similarly organizes physicians and other healthcare
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`professionals to promote policies that protect human and environmental
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`health on matters ranging from climate change to gun violence to toxic
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`chemicals. Both groups support right-to-know laws that enable people
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`to better understand and limit exposure to toxic chemicals in their
`
`everyday lives.
`
`Toxics policy reform advocates Californians for Pesticide Reform
`
`(CPR) and Pesticide Action Network North America (PANNA) are,
`
`respectively, statewide and nationwide coalitions of organizations
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`working to fundamentally shift the way hazardous pesticides are used.
`
`CPR builds leadership in communities living on the front lines of
`
`pesticide exposure, and has led successful campaigns to eliminate the
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`use of glyphosate and other harmful synthetic pesticides from schools,
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`parks, and other public lands in California. PANNA’s network of
`
`organizations likewise supports Proposition 65 as part of its work
`
`defending communities most at risk of exposure to hazardous
`
`pesticides, including farmworkers, family farmers, and children living
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`in agricultural communities.
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`6
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`
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`Shareholder advocacy group As You Sow was founded in 1992 to
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`promote environmental and social corporate responsibility through
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`business collaboration, coalition building, and innovative legal
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`strategies. Among its other advocacy strategies, As You Sow works to
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`lower consumer and occupational exposures to toxics by bringing
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`manufacturers and industries into compliance with Proposition 65.
`
`BACKGROUND
`
`A.(cid:3)Regulation in the context of evolving scientific knowledge
`
`Courts have long recognized that regulators must sometimes act
`
`based on the available scientific information because a wait-and-see
`
`approach can imperil health and the environment. In a seminal opinion
`
`reviewing limits on lead in gasoline, the D.C. Circuit acknowledged that
`
`“[q]uestions involving the environment are particularly prone to
`
`uncertainty,” and “speculation, conflicts in evidence, and theoretical
`
`extrapolation typify” regulatory actions in this realm. Ethyl Corp. v.
`
`EPA, 541 F.2d 1, 24 (D.C. Cir. 1976). “[S]tatutes and common sense
`
`demand regulatory action to prevent harm, even if the regulator is less
`
`than certain that harm is otherwise inevitable.” Id. at 25; accord United
`
`Steelworkers of Am. v. Marshall, 647 F.2d 1189, 1252 (D.C. Cir. 1980)
`
`7
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`
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`(noting, in review of workplace lead limits, that Congress intended
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`agency “to act firmly even in the face of medical uncertainty, not to be
`
`paralyzed by debate surrounding diverse medical opinions” (quotation
`
`marks omitted)).
`
`This Court has similarly accorded leeway to agencies, allowing
`
`actions that “risk[] error on the side of overprotection rather than
`
`underprotection” in limiting occupational exposure to toxins, ASARCO,
`
`Inc. v. Occupational Safety & Health Admin., 746 F.2d 483, 490 (9th
`
`Cir. 1984) (denying industry challenge to arsenic regulations)
`
`(quotation marks omitted), and in preserving ecologically sensitive
`
`areas of the ocean, NRDC v. Pritzker, 828 F.3d 1125, 1138 (9th Cir.
`
`2016) (noting incomplete “state of the science” and “data-poor areas” of
`
`the world’s oceans).
`
`In the realm of consumer product regulations, cigarette warnings
`
`and related commercial restrictions are examples of laws issued even
`
`when the danger of smoking had “not [been] established beyond all
`
`doubt” (doubt largely sown by the tobacco industry, see infra p. 28).
`
`Banzhaf v. FCC, 405 F.2d 1082, 1097 (D.C. Cir. 1968) (upholding
`
`advertising restrictions). When the link between smoking and lung
`
`8
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`
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`disease was emerging in the 1960s, the federal government required
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`tobacco companies to include a statement on cigarette packs that
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`smoking is hazardous to health. See Federal Cigarette Labeling and
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`Advertising Act, Pub. L. No. 89-92, § 4, 79 Stat. 282, 283 (1965).
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`Courts have also upheld food labeling rules even when the science
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`is unsettled or the benefit of labeling is disputed. In reviewing a state
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`disclosure rule for genetically modified ingredients, a district court
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`acknowledged “conflicting studies assessing the health consequences” of
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`such food and dismissed industry plaintiffs’ concern that the required
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`label would carry a negative connotation. Grocery Mfrs. Ass’n v. Sorrell,
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`102 F. Supp. 3d 583, 597-98 (D. Vt. 2015); see id. at 625 (holding that
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`requirement was not “viewpoint discrimination” even though it “reflects
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`the State’s preference for a legislative outcome”). And in a challenge to
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`a city rule requiring calorie information on menus, the Second Circuit
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`rejected restaurant plaintiffs’ argument that they “do not believe that
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`disclosing calorie information would reduce obesity, and would prefer to
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`provide complete nutrition information” instead of calorie listings. N.Y.
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`State Rest. Ass’n v. N.Y.C. Bd. of Health, 556 F.3d 114, 131-34 (2d Cir.
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`2009) (rejecting First Amendment claims).
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`9
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`B.(cid:3)Proposition 65 and glyphosate
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`Consistent with the traditional rule that states have “great
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`latitude under their police powers to legislate as to the protection of the
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`. . . health . . . of all persons,” Medtronic, Inc. v. Lohr, 518 U.S. 470, 475
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`(1996) (quotation marks omitted), California voters approved
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`Proposition 65 to warn the public of health risks posed by products they
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`use or to which they may be otherwise exposed. Proposition 65 requires
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`the Governor of California to publish a list of chemicals known to the
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`State to cause cancer. Cal. Health & Safety Code § 25249.8. As further
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`explained below, the inclusion of chemicals on the list is a two-step
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`process in which the State first determines if a chemical causes harm
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`(the hazard identification step). See Cal. Code Regs. tit. 27, § 25904
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`(b)(2), (3). If so, the State then identifies the circumstances in which
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`harm is expected, including assessing levels of chemical exposure at
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`which harm may occur (the risk characterization step). See id. § 25705;
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`Cal. Health & Safety Code § 25249.10(c).
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`A chemical is “known to the state to cause cancer” if it is
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`recognized as a carcinogen by specified expert entities or identified on
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`certain lists—including, as relevant here, lists under California Labor
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`10
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`Code section 6382(b)(1). See Cal. Health & Safety Code § 25249.8(a)
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`(incorporating labor code provision). The Labor Code provision, in turn,
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`incorporates chemicals identified by IARC as human or animal
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`carcinogens. Cal. Labor Code § 6382(b)(1); see also Cal. Code Regs. tit.
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`27, § 25306(m)(1). IARC is a highly respected intergovernmental
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`research arm of the United Nation’s World Health Organization, tasked
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`with making carcinogen hazard assessments. See World Health
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`Organization, IARC Monographs on the Evaluations of Carcinogenic
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`Risks to Humans: Preamble 1 (2006).3 Federal and state regulators
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`routinely refer to IARC’s independent assessments and recognize the
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`agency as one of the world’s leading authorities on carcinogen analysis.
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`See, e.g., Occupational Safety and Health Administration, Occupational
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`Exposure to Beryllium, 82 Fed. Reg. 2470, 2540 (Jan. 9, 2017) (citing
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`IARC’s findings on lung cancer); Cal. Chamber of Commerce v. Brown,
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`126 Cal. Rptr. 3d. 214, 236 (Ct. App. 2011) (noting that IARC was one of
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`“several well-recognized sources to which manufacturers already
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`routinely referred to obtain hazard information”); see also 6-ER-1231 –
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`(cid:3)
`3 http://monographs.iarc.fr/ENG/Preamble/CurrentPreamble.pdf
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`11
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`Case: 20-16758, 02/19/2021, ID: 12010574, DktEntry: 22, Page 21 of 49
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`6-ER-1236 (listing dozens of state regulations that rely on IARC
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`carcinogenicity findings).
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`If a product contains a Proposition 65-listed chemical, the
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`business is generally required to give a “clear and reasonable warning”
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`regarding that exposure. Cal. Health & Safety Code § 25249.6.
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`Businesses may seek an exemption from the requirement by requesting
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`a “safe use determination” from California’s Office of Environmental
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`Health Hazard Assessment, showing that the level of exposure poses
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`“no significant risk” of cancer. Id. § 25249.10(c); see Cal. Code Regs. tit.
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`27, § 25705. For many of the listed chemicals, the State calculates an
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`exposure level below which the risk is deemed not significant. Cal. Code
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`Regs. tit. 27, § 25705. The State also provides guidelines to businesses
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`on how to conduct quantitative risk assessments to determine whether
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`a product causes an exposure that poses no significant risk. Cal. Health
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`& Safety Code § 25249.10(c); Cal. Code Regs. tit. 27, §§ 25701(a), 25703,
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`25705, 25721.
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`Glyphosate is a broad-spectrum herbicide widely used in
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`agriculture (including soybean, cotton, and oats), parks, home gardens,
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`and residential landscapes. IARC determined in 2015 that glyphosate is
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`12
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`Case: 20-16758, 02/19/2021, ID: 12010574, DktEntry: 22, Page 22 of 49
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`“probably carcinogenic” to humans based on: “limited evidence” of
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`cancer in studies of real-world occupational exposures to formulated
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`products; “sufficient evidence” from laboratory rodent studies; and,
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`“strong evidence” that pure glyphosate and glyphosate-based products
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`causes the kind of cell damage that is known to lead to cancer. IARC,
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`Q&A on Glyphosate (2016)4; see also 6-ER-1126 (IARC Monograph).
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`Following IARC’s finding, in July 2017, the Office of
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`Environmental Health Hazard Assessment (OEHHA) placed glyphosate
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`on the State’s Proposition 65 list. Businesses were therefore required to
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`include a warning label on glyphosate-containing products starting July
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`2018, unless they could show that the level of exposure from the product
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`posed no significant risk of cancer. See Cal. Health & Safety Code
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`§§ 25249.6, 25249.10. This requirement never went into effect, however,
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`because of the ensuing litigation. See infra p. 16.
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`In April 2018, after providing public notice and opportunity to
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`comment, California finalized the No Significant Risk Level for
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`glyphosate at 1100 micrograms/day. OEHHA, Amendment to Section
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`(cid:3)
`4 https://www.iarc.fr/wp-content/uploads/2018/11/QA_Glyphosate.pdf
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`13
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`25705 No Significant Risk Level–Glyph