Posted: 22 Oct 2019 07:05 PM PDT By Riëtte van Laack — On October 8, 2019, the California Chamber of Commerce (CalChamber) filed a lawsuit in federal district court against the State of California requesting that the Court enjoin the State, its agents and private enforcers from requiring Prop. 65 warnings on foods that contain acrylamide. Plaintiff claims that the requirement for a Prop. 65 warning is illegal because it compels Plaintiff’s members and other entities that produce, distribute, or sell acrylamide-containing food products to make false, misleading, and highly controversial statements about their products. In addition, the warning requirement allegedly will mislead consumers into avoiding certain foods based on incorrect information. Further, over-warning purportedly dilutes the effectiveness of Proposition 65 warnings on other products that actually pose a risk of harm to consumers, diminishes consumers’ confidence in public health messages and the authorities who promulgate them, and may result in avoidance of foods that are part of a well-balanced diet. Prop. 65 is officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986. With some exceptions, Prop. 65 prohibits businesses with ten or more employees from knowingly and intentionally exposing California residents to a chemical known to the State to cause cancer without providing required warnings. Prop. 65 requires that the California Office of Environmental Health Hazard Assessment (OEHHA) maintain a list of chemicals known to the state to cause cancer or reproductive toxicity. A chemical is “known to the state to cause cancer” if “a body considered to be authoritative by [the state’s qualified] experts has formally identified it as causing cancer.” No warning is required if the exposure is below the No Significant Risk Level (NSRL), i.e., the level at which exposure poses no significant risk, assuming lifetime exposure at the level in question for the substance. Prop. 65 has what is often referred to as a bounty hunter provision. Under the statute, any person (even one who has suffered no injury) may bring a private enforcement action for an alleged failure to provide an adequate warning. Such private enforcers are eligible to recover 25 percent of the penalty (the statute imposes penalties up to $2,500 per day for each violation) and their reasonable attorneys’ fees and costs, creating very strong incentives for private enforcement. Such bounty hunters have a low burden. In alleging an exposure to a listed chemical, they are not required to prove that an exposure exceeds the NSRL. Instead, the burden is on the defendant business to prove that exposure is below the NSRL (a potentially costly endeavor). Acrylamide is the result of a chemical reaction (known as the Maillard reaction) which takes place in certain types of starchy foods when they are cooked at high temperatures or otherwise processed using heat. The Maillard reaction contributes to taste, aroma and color. It occurs in a multitude of foods such as French fries, breakfast cereals, baked goods and roasted coffee. FDA has recognized that acrylamide forms during the cooking process and is present in both store-bought foods and home-cooked foods. Acrylamide has been on the Prop. 65 list as a potential carcinogen since 1990 based on identification by “authoritative bodies,” namely the International Agency for Research on Cancer (IARC) and the U.S. Environmental Protection Agency (“EPA”). Both the EPA and IARC classifications of acrylamide as a “probable” human carcinogen were based on studies in laboratory animals in which virtually pure acrylamide was administered orally or via injection to rats and mice. However, according to Plaintiff CalChamber, there is no evidence that acrylamide is a carcinogen in humans, and IARC, EPA, and as the State have acknowledged the lack of evidence that dietary acrylamide is a human carcinogen. Further, studies have shown that certain foods that contain acrylamide, such as coffee, may reduce the risk of cancer in humans. Nevertheless, dietary acrylamide remains on the Prop. 65 list and remains a popular target for bounty hunters. According to CalChamber, since its addition to the list, there have been more than 500 notices for alleged violations of the Prop. 65 warning requirement related to acrylamide in food products. Companies trying to avoid the cost of defending actions and penalties, as well as costly and complicated testing, may decide to include the warning. Thus, consumers may be misled and be exposed to over-warning. CalChamber requests that the Court declare that the Prop. 65 warning requirement for cancer relating to acrylamide in human food products violates the First Amendment of the United States Constitution, and enjoin the State as well as bounty hunters from enforcing or threatening to enforce the Prop. 65 warning requirement for cancer relating to acrylamide in human food products. |
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