The Council for Education and Research on Toxics ("CERT"), A.K.A. Raphael Metzger of the Metzger Law Group, filed a lawsuit against more than 90 coffee sellers alleging defendants' coffee "contains anywhere from 4 to well over 100 times more acrylamide than the No Significant Risk Level ("NSRL") for acrylamide established by California's Office of Environmental Health Hazard Assessment ("OEHHA"). (Council for Education and Research on Toxics v. Starbucks Corp., et al. [Super. Ct. L.A. County, No. BC435759].) CERT claims defendants violated Proposition 65 by failing to warn consumers that exposure to acrylamide in coffee poses a risk of cancer. During the first phase of a bifurcated trial, the Court addressed defendants' affirmative defenses. Defendants argued they were not required to place Proposition 65 compliant warnings on their products because exposure acrylamide in defendants' coffee poses no significant risk of cancer. However, the Court disagreed with defendants, finding that they failed to present sufficient credible scientific evidence proving that the level of exposure to acrylamide in coffee poses no significant risk of cancer.
One of the primary goals of Proposition 65 ("Prop 65") is to inform consumers about potential exposures to chemicals known by the State of California to cause cancer. Although it has been almost 30 years since it was enacted as a ballot initiative, Prop 65 remains controversial, in large part because it requires businesses to make crucial scientific determinations about safety levels for chemicals in their products that are identified by Prop 65.
OEHHA, which is part of the California Environmental Protection Agency, is charged with implementation of Prop 65 and has adopted regulations establishing NSRLs, exposure levels at which specific listed chemicals are deemed to pose no significant risk. (Cal. Code Regs., tit. 27, §§ 25701 et seq.) However, of the over 800 substances that are on the list of chemicals known to cause cancer, birth defects or other reproductive harm, OEHHA has only developed NSRLs for about 300 chemicals. A business has "safe harbor" from Prop 65 warning requirements if exposure to a chemical occurs at or below these NSRLs. Unless there is a NSRL creating a "safe harbor," a business will only be exempt from the warning requirement of Prop 65 if a quantitative risk assessment conducted by the business establishes that exposure to a chemical would not result in more than one excess case of cancer in an exposed population of 100,000 — assuming a lifetime exposure of 70 years at the level in question. (Cal. Code Regs., tit. 27, § 25703, subd. (b).)
If a business determines, through a "quantitative risk assessment," that the level of exposure to a Prop 65 chemical contained in its product poses no significant risk of cancer, then it may not be required to provide a Prop 65 compliant warning on its products. However, as exemplified by CERT v. Starbucks Corp., et al., a flawed or otherwise invalid determination that a Prop 65 compliant warning is not necessary because the level of exposure poses no significant risk of cancer, could subject a business to liability, monetary penalties, and attorneys' fees.
In CERT v. Starbuck Corp., et al., the trial court ruled that much of the defendants' risk assessment lacked scientific support and that defendants had not established a degree of risk under a "quantitative risk assessment;" which is "the only type of risk assessment utilized by the relevant scientific community to assess the risk of a carcinogen in a mixture." Although OEHHA established an NSRL for Acrylamide of .2mg, defendants argued that a Prop 65 compliant warning was unnecessary because studies show that consumption of coffee does not increase the risk of cancer. However, according to the Court defendants presented evidence of an assessment of the mixture of coffee rather than an assessment of the acrylamide in the coffee. Because coffee itself is not a substance known to the State of California to cause cancer, defendants assessment was insufficient to satisfy the statutory requirement of determining the level of risk of cancer from exposure to acrylamide, the chemical known to the State of California to cause cancer, in the coffee.
A quantitative risk assessment must determine the level of exposure at which a chemical poses no significant risk "based on evidence and standards of comparable scientific validity to those which form the scientific basis for listing the chemical as known to the state to cause cancer." (Cal. Code Regs., tit. 27, § 25703, subd. (a).) For exposures to potential carcinogens in consumer products such as coffee, the lifetime exposure of 70 years is calculated using the average rate of intake or exposure for the average user, which is based on data such as the United States Department of Agriculture Home Economic Research Report, Foods Commonly Eaten by Individuals: Amount Per Day and Per Eating Occasion. (Cal. Code Regs., tit. 27, § 25721, subd. (a)4.)
However, in instances where more appropriate scientific data, such as the study above, is not available, the statute requires that a quantitative risk assessment consider several statutorily defined principles and assumptions addressing exposures to cancer causing chemicals (See Cal. Code Regs., tit. 27, § 25703, subd. (a),http://oehha.ca.gov/prop65/law/pdf_zip/RegsArt7.pdf.) Of course, application of these principles and assumptions is easier said than done.
Having completed the first phase of the trial in CERT v. Starbuck Corp., et al., the parties must now meet and confer on the issues to be addressed in the second phase, including the issues CERT will address in its prima facie case, affirmative defenses applicable to individual defendants, a proposed discovery plan, and proposals for expanding the scope of the second phase of trial.
The Court's ruling on the first phase of trial in CERT v. Starbuck Corp., et al. should serve as a reminder of a defendant's burden to prove that the level of exposure to a chemical constitutes no significant risk. (See Health & Safety Code, §25249.10 subd. (c).) If a business believes that it is not required to place a Prop 65 warning on a product because exposure to a chemical poses no significant risk level, then it should perform a quantitative risk assessment and ensure through scientifically valid evidence, of the same quality as used by OEHHA to place chemicals within the purview of Prop 65, that exposure to a chemical constitutes no significant risk. (Cal. Code Regs., tit. 27, § 25703.)
Understanding the importance of a scientifically valid quantitative risk assessment is critical for any business seeking to bring products which may contain Prop 65 chemicals to market in California.
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