The scope of products to be drawn into the warning requirements under California’s Proposition 65 law may soon be growing. California’s Office of Environmental Health Hazard Assessment (OEHHA) requested information from the public on the reproductive toxicity of p,p’-bisphenol chemicals. OEHHA is the lead agency for the implementation of Proposition 65, formerly known as the Safe Drinking Water and Toxicity Enforcement Act of 1986. OEHHA’s request for information is a step toward regulators classifying all p,p’-bisphenol chemicals as reproductive toxicants under Proposition 65.
California’s Proposition 65
Under Proposition 65, businesses are required to post clear and reasonable warnings before individuals are exposed to chemicals listed by the state of California as carcinogens or reproductive toxicants. To date, California has listed approximately 900 chemicals that fall under Proposition 65 regulation. Businesses may be held liable for up to $2,500 per violation per day. Proposition 65 can be enforced by public prosecutors (e.g., the California attorney general or district attorneys) or by private enforcers (known as “bounty hunters”).
Proposition 65 cases are often litigated through expert analysis to determine if an exposure occurred above what is considered to be the No Significant Risk Level or Maximum Allowable Dose Level for the respective chemical. Due to the significant costs required to litigate the defense of a Proposition 65 case, many settle before litigation, which typically includes a civil penalty, attorneys’ fees, and a requirement that clear and reasonable warnings are posted prior to exposing consumers to any Proposition 65 chemicals.
P,p’–bisphenol Chemicals
The Developmental and Reproductive Toxicant Identification Committee (DARTIC) of OEHHA’S Science Advisory Board serves as California’s qualified experts on the reproductive toxicity of a chemical. OEHHA has tasked DARTIC with reviewing p,p’-bisphenol chemicals for a possible listing under Proposition 65 due to their potential connection with reproductive toxicity. P,p’-bisphenol chemicals include p,p’-bisphenols and ethers and esters of p,p’-bisphenols. OEHHA has given the public an opportunity to provide information relevant to the assessment of reproductive toxicity from exposure to p,p’-bisphenol chemicals. Relevant information on p,p’-bisphenol chemicals includes epidemiological studies and animal studies.
Importantly, bisphenol compounds are a common component of many consumer and industrial products. Presently, two bisphenol chemicals have already been listed as reproductive toxicants under Proposition 65: bisphenol A (BPA) and bisphenol S (BPS). The inclusion of BPA and BPS under Proposition 65 triggered substantial enforcement actions by private plaintiff bounty hunters, which, in turn, significantly affected the business community as companies navigated these regulatory changes and enforcement initiatives.
Many companies substituted the use of BPA or BPS with other chemicals that would fall within the definitional scope of the p,p’-bisphenol chemical group now being examined. If OEHHA now decides to list the entire class of p,p’-bisphenol chemicals as reproductive toxicants under Proposition 65, many companies will once again be subject to additional Proposition 65 enforcement efforts after already incurring significant expenses to reformulate products to eliminate BPA and BPS.
Although not exhaustive, the following types of products would be of particular concern with this potential new listing: food and beverage packaging and containers, medical devices, construction materials, household appliances, hard plastic materials, and food products.
Protective Measures for Businesses
The potential listing of this entire class of chemicals poses a significant logistical and compliance challenge for businesses, some of which have already incurred the expense and effort required to switch from BPA or BPS in products to other p,p’-bisphenols to maintain compliance with Proposition 65. Companies should be mindful of whether this possible listing is enacted. To assist clients in staying informed, GRSM will provide an update on this matter. Proposition 65 provides a one-year grace period between the time a chemical is listed and the time that enforcement can begin.
If OEHHA does add p,p’-bisphenols to the Proposition 65 list of chemicals, manufacturing companies should conduct a supply chain review to determine any potential issues with products containing p,p’-bisphenols. Downstream companies should ensure that suppliers are providing them with products that are in compliance with Proposition 65, including any products containing p,p’-bisphenol chemicals.
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