The Latest in the Prop. 65 World: Jury Trials; Inorganic Arsenic in Rice; and the FDA Weighs in on Coffee

Environmental Law  

September 6, 2018


There have been several major developments in the Proposition 65 world this summer.  Below we summarize these latest developments in more detail.  They include: (1) the California Court of Appeal, First Appellate District suggesting that jury trials may be available to Prop. 65 defendants, (2) the Office of Environmental Health Hazard Assessment’s (OEHHA) issuance of a new regulation that sets default natural background levels for inorganic arsenic in white and brown rice, and, (3) the U.S. Food and Drug Administration’s (FDA) issuance of a formal statement that it supports exempting coffee from Proposition 65 warning requirements.

California’s Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986—or “Prop. 65”—prohibits businesses from releasing chemicals “known to the state to cause cancer or reproductive toxicity,” and from exposing people to chemicals on the Prop. 65 List without providing “clear and reasonable” warnings. 

First Appellate District Suggests Jury Trials May Be Available for Defendants

On June 13, 2018, the First Appellate District suggested that jury trials may be available to defendants in Prop. 65 enforcement matters.  Nationwide Biweekly Admin., Inc. v. Superior Court of Alameda Cty., Case No. A150264 (June 13, 2018).  The First Appellate District disagreed with a prior appellate court’s decision (DiPirro v. Bondo Corp., 153 Cal.App.4th 150 (2007)), which held that due to the “equitable principles” tied to Prop. 65, there was no right to a jury trial in an action by a private individual seeking injunctive relief, restitution, civil penalties, as well as attorney’s fees and costs.  The First Appellate District in Nationwide pointed out that the DiPirro court overlooked United States Supreme Court precedent that a right to a jury trial exists as to the liability in a government enforcement action for statutory penalties, even though no right to a jury trial exists with respect to the amount of statutory civil penalties.  Although Nationwide did not hold that there is a right to a jury trial in Prop. 65 enforcement matters and it did not overturn DiPirro, the First Appellate District’s criticism of the DiPirro decision leaves that decision in doubt and open to challenges in the future.

OEHHA Sets Default Natural Background Levels for Inorganic Arsenic in Rice

On August 2, 2018, the Office of Administrative Law formally approved OEHHA’s adoption of Title 27 California Code of Regulations section 25501.1, which establishes default natural background levels for inorganic arsenic in white and brown rice.  OEHHA originally added inorganic arsenic compounds to the Prop. 65 List in 1987 as a carcinogen, and inorganic arsenic oxides as causing developmental toxicity in 1997.  Inorganic arsenic naturally occurs in certain types of foods such as rice because the chemical is absorbed from the soil and accumulated in the plant as rice grows.  Section 25501.1 sets the threshold concentration for naturally occurring levels of inorganic arsenic in white rice at 80 parts per billion (ppb) and 170 ppb for brown rice.  Both concentration levels are for dry rice grain, before food preparation.  Moreover, these levels are intended to provide guidance for businesses that sell or distribute rice in California in order to determine the applicability of Prop. 65 warning requirements.

FDA Issues Statement in Support of Exempting Coffee from Prop. 65 Warning Requirements

Finally, on August 29, 2018, the FDA issued a formal statement in support of exempting coffee from Prop. 65 warning requirements.  As previously reported earlier this year, the Superior Court for the County of Los Angeles issued a decision that certain ready-to-drink coffee sold in California requires Prop. 65 warnings due to the presence of acrylamide.  Following that decision, OEHHA issued a draft regulation that, if adopted, would mean that no Prop. 65 cancer warning would be required for coffee.  OEHHA originally added acrylamide to the Prop. 65 List in 1990 as a carcinogen.  Later, in 2011, OEHHA identified developmental toxicity and male reproductive toxicity as endpoints for acrylamide.  Acrylamide forms in certain plant-based foods when they are cooked or roasted under high temperatures. 

FDA stated that it is “deeply concerned” with the Superior Court’s decision and believes that “requiring a cancer warning on coffee, based on the presence of acrylamide, would be more likely to mislead consumers than to inform them.”  Instead, “[s]trong and consistent evidence shows that in healthy adults moderate coffee consumption is not associated with an increased risk of major chronic diseases, such as cancer, or premature death, and some evidence suggests that coffee consumption may decrease the risk of certain cancers.”  In addition, the FDA “strongly supports” OEHHA’s related proposal to issue a new regulation to help clarify that Prop. 65 cancer warnings are not required for coffee products.  Although FDA’s statement does not have any legal effect on the Superior Court’s decision, FDA’s statement provides some indication that FDA may be more willing to provide guidance or take a position on certain food items.  And, as we learned from the recent breakfast cereal decision, when FDA weighs in, California courts are starting to listen and find federal interests trump Prop. 65.

For assistance in complying with Prop 65 enforcement matters, please contact us.