Posted: 07 Jul 2020 06:44 PM PDT
By Riëtte van Laack & Karin F.R. Moore —
On June 22, 2020, the Eastern District of California entered a permanent injunction barring enforcement of the Proposition 65 (Prop 65) cancer warning requirements for glyphosate. Those familiar with Prop. 65 know that a win for industry battling Prop 65 is a rare event.
California Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, is a state law that requires that the Governor of California publish a list of chemicals (the Prop 65 list) known to the State to be a reproductive toxicant or to cause cancer, as determined by certain authoritative entities, including the United States Environmental Protection Agency (EPA) and the International Agency for Research on Cancer (IARC). Prop 65 prohibits businesses from knowingly exposing individuals to listed substances without providing a clear and reasonable warning
In 2017, after the IARC classified glyphosate as “probably carcinogenic” to humans based on evidence that it caused cancer in experimental animals and could cause cancer in humans, the substance was added to the Prop 65 list as a cancer-causing chemical. IARC’s determination was inconsistent with determinations by other authorities, such as the EPA and the European Commission, which had concluded that glyphosate is not likely to be carcinogenic in humans. In fact, IARC was the only entity that determined that glyphosate was a probable carcinogen.
On November 14, 2017, Plaintiffs Monsanto and several farming associations sued the State of California alleging that the listing of glyphosate under Prop 65 as a carcinogen, and the resulting warning requirements, violated Plaintiffs’ First Amendment rights by forcing them to make “false, misleading, and highly controversial statements.” The Court initially entered a preliminary injunction precluding enforcement of the warning rules.
The Court considered whether California’s regulation of commercial speech should be scrutinized under the standard set by the Supreme Court in Zauderer v. Office of Disciplinary Counsel or under the intermediate standard set by Central Hudson Gas & Electric v. Public Service Commission. The Zauderer standard applies to mandatory disclosure of “purely factual and uncontroversial information.” In light of the inconsistency between the finding of IARC and others, such as EPA, the Court found that the Prop 65 warning for glyphosate was not factual and not uncontroversial. Thus, the higher standard of scrutiny of the Central Hudson level would apply. Under that standard, a governmental agency may restrict commercial speech when the restriction directly advances an important governmental interest and the restriction may not be more extensive than necessary to serve that governmental interest. The Court determined that the Prop 65 warning for glyphosate is misleading because it requires a warning that the chemical is known to the state of California to cause cancer when that statement is not true – only one organization concluded glyphosate was “probably carcinogenic” (IARC), and a multitude of other organizations that reviewed the safety of the product found the opposite. Requiring a misleading statement does not directly advance the interest of the state in informing consumers regarding potential cancer hazards. Thus, the warning could not be justified as a valid restriction on commercial speech and, therefore, is contrary to the First Amendment of the Constitution.
California argued that it had set a quantitative “safe harbor” level for glyphosate exposure that in practice means that few if any products would need to include a Prop 65 warning. However, the Court found that a safe-harbor level does not protect companies from enforcement actions; even if a product were tested and found to contain glyphosate well below the safe harbor level, there was no reasonable assurance that a company would not be subject to enforcement actions. In fact, there have been enforcement actions for various chemicals notwithstanding a defense of compliance with the safe harbor level for those chemicals, including where the California Attorney General said a proposed enforcement suit had no merit.
The statute allows any person to file an enforcement suit notwithstanding the State’s finding of no merit. To bring suit, a private party need only credibly allege that that a product has some amount of the chemical at issue, not that the amount of the chemical is harmful or that it exceeds the safe harbor level; defendants in Proposition 65 enforcement actions have the burden of showing that the level of the chemical in their product falls below the safe harbor level. As a result, without a permanent injunction, Plaintiffs in this case would face a credible threat of enforcement regardless of the safe harbor level for glyphosate.
As we previously reported, there is a similar First Amendment challenge to the required Prop 65 warning for acrylamide filed in October 2019. Similar to the case with glyphosate, neither OEHHA nor any other governmental entity has determined that acrylamide is a known human carcinogen; in fact, OEHHA acknowledged that the agency does not know that acrylamide increases the risk of cancer in humans. That case is still ongoing, and the glyphosate decision could greatly impact the ongoing acrylamide litigation.
We will be monitoring further developments.
On June 22, 2020, the Eastern District of California entered a permanent injunction barring enforcement of the Proposition 65 (Prop 65) cancer warning requirements for glyphosate. Those familiar with Prop. 65 know that a win for industry battling Prop 65 is a rare event.
California Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, is a state law that requires that the Governor of California publish a list of chemicals (the Prop 65 list) known to the State to be a reproductive toxicant or to cause cancer, as determined by certain authoritative entities, including the United States Environmental Protection Agency (EPA) and the International Agency for Research on Cancer (IARC). Prop 65 prohibits businesses from knowingly exposing individuals to listed substances without providing a clear and reasonable warning
In 2017, after the IARC classified glyphosate as “probably carcinogenic” to humans based on evidence that it caused cancer in experimental animals and could cause cancer in humans, the substance was added to the Prop 65 list as a cancer-causing chemical. IARC’s determination was inconsistent with determinations by other authorities, such as the EPA and the European Commission, which had concluded that glyphosate is not likely to be carcinogenic in humans. In fact, IARC was the only entity that determined that glyphosate was a probable carcinogen.
On November 14, 2017, Plaintiffs Monsanto and several farming associations sued the State of California alleging that the listing of glyphosate under Prop 65 as a carcinogen, and the resulting warning requirements, violated Plaintiffs’ First Amendment rights by forcing them to make “false, misleading, and highly controversial statements.” The Court initially entered a preliminary injunction precluding enforcement of the warning rules.
The Court considered whether California’s regulation of commercial speech should be scrutinized under the standard set by the Supreme Court in Zauderer v. Office of Disciplinary Counsel or under the intermediate standard set by Central Hudson Gas & Electric v. Public Service Commission. The Zauderer standard applies to mandatory disclosure of “purely factual and uncontroversial information.” In light of the inconsistency between the finding of IARC and others, such as EPA, the Court found that the Prop 65 warning for glyphosate was not factual and not uncontroversial. Thus, the higher standard of scrutiny of the Central Hudson level would apply. Under that standard, a governmental agency may restrict commercial speech when the restriction directly advances an important governmental interest and the restriction may not be more extensive than necessary to serve that governmental interest. The Court determined that the Prop 65 warning for glyphosate is misleading because it requires a warning that the chemical is known to the state of California to cause cancer when that statement is not true – only one organization concluded glyphosate was “probably carcinogenic” (IARC), and a multitude of other organizations that reviewed the safety of the product found the opposite. Requiring a misleading statement does not directly advance the interest of the state in informing consumers regarding potential cancer hazards. Thus, the warning could not be justified as a valid restriction on commercial speech and, therefore, is contrary to the First Amendment of the Constitution.
California argued that it had set a quantitative “safe harbor” level for glyphosate exposure that in practice means that few if any products would need to include a Prop 65 warning. However, the Court found that a safe-harbor level does not protect companies from enforcement actions; even if a product were tested and found to contain glyphosate well below the safe harbor level, there was no reasonable assurance that a company would not be subject to enforcement actions. In fact, there have been enforcement actions for various chemicals notwithstanding a defense of compliance with the safe harbor level for those chemicals, including where the California Attorney General said a proposed enforcement suit had no merit.
The statute allows any person to file an enforcement suit notwithstanding the State’s finding of no merit. To bring suit, a private party need only credibly allege that that a product has some amount of the chemical at issue, not that the amount of the chemical is harmful or that it exceeds the safe harbor level; defendants in Proposition 65 enforcement actions have the burden of showing that the level of the chemical in their product falls below the safe harbor level. As a result, without a permanent injunction, Plaintiffs in this case would face a credible threat of enforcement regardless of the safe harbor level for glyphosate.
As we previously reported, there is a similar First Amendment challenge to the required Prop 65 warning for acrylamide filed in October 2019. Similar to the case with glyphosate, neither OEHHA nor any other governmental entity has determined that acrylamide is a known human carcinogen; in fact, OEHHA acknowledged that the agency does not know that acrylamide increases the risk of cancer in humans. That case is still ongoing, and the glyphosate decision could greatly impact the ongoing acrylamide litigation.
We will be monitoring further developments.
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