California Finally Proposes a Prop 65 Cancer Safe Harbor Level for Diethanolamine

The proposal is intended to give businesses clearer guidance when determining whether a cancer warning is required, and it will remain open for public comment through October 6.

Under Proposition 65, a business must provide a cancer warning for a listed carcinogen unless it can demonstrate that the exposure level presents no more than a 1-in-100,000 lifetime excess cancer risk. OEHHA’s NSRLs function as voluntary “safe harbors.” Companies may use these state-established thresholds to perform their own quantitative exposure assessments.

Although DEA itself is not used as an ingredient in consumer products such as cosmetics and other personal care items, it may be present as a contaminant in products containing triethanolamine, a commonly used emulsifier, surfactant, and pH adjuster. Products designed for application to the human skin, and that list triethanolamine as an ingredient, have thus become a target for Proposition 65 bounty hunters who may file a notice of violation (NOV) when any level of DEA is detected in a lab analysis. Common targets of such NOVs include manufacturers and suppliers of many types of cosmetic and personal care products, including foundation, moisturizers, shampoo, styling gels, conditioners, and even mascara.

OEHHA proposes an NSRL of 6.4 micrograms per day for DEA, which applies only to dermal exposure. This value is derived from OEHHA’s quantitative analysis of rodent carcinogenicity data, consistent with the agency’s Proposition 65 assessment methodology. In the past, and in the absence of an official NSRL for DEA, challenging such NOVs has been problematic for manufacturers and suppliers. The new dermal NSRL is therefore expected to streamline compliance for many businesses, particularly those lacking in-house toxicology expertise, and may help reduce or eliminate NOVs that are based on trivial concentrations of DEA. OEHHA expects that businesses will not incur new costs, as products above these thresholds already require warnings.

Interested parties may request a public hearing no later than September 22, and written comments must be submitted no later than October 6. ArentFox Schiff’s Consumer Products group will continue to monitor this development and is available to answer any questions you may have. Please feel free to reach out to the authors or any attorney on our team.