Home » U.S. State Regulatory » California » Proposition 65 (OEHHA)
CALIFORNIA'S PROPOSITION 65
California 's Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65)
- “Carcinogens” and “Reproductive Toxins” are placed on a list of chemicals “known to the state”.
- Requires companies to provide “clear and reasonable warnings” to persons with California that are exposed to these chemicals.
- Prohibits discharges of listed chemicals into a potential sources of drinking water.
- Warnings and prohibitions are not required if can be shown that exposures are “insignificant” under Prop 65, as established by risk assessment.
- Enforced through litigation, burden of proof on defendant.
TSG has extensive expertise and experience in assessing the “significance” of potential exposures and providing companies with documentation forming the basis the determination. TSG also provides letters for business partners and users regarding the requirements specific to Prop 65.
Proposition 65 requires California to ‘list' chemicals “known to the state” to cause cancer or reproductive toxicity. Warning and discharge requirements are triggered 12 and 20 months, respectively, after a chemical is listed unless exposures are shown to be insignificant in comparison to an exposure threshold. The exposure threshold is commonly called the “Safe Harbor Level” (also the No Significant Risk Level – NSRL, and Maximum Acceptable Daily Level - MADL). TSG provides the following:
- Coordination of efforts involving proposed addition of compounds onto the Prop 65 list or, once listed, efforts to remove chemicals from the list.
- Development of underlying documentation supporting the assessment.
- Safe Harbor Level determination when a default level has not been established by California 's Office of Environmental Health Hazard Assessment (OEHHA).
- Guidance on the significance of exposures and follow up support, as necessary.
- Proposition 65 is enforced by litigation with the burden of proof placed on businesses rather the plaintiff.
TSG's staff have been active in Proposition 65 since it was approved by the voters in November 1986. TSG is experienced at conducting risk assessments and providing underlying documentation to deter litigation. TSG is also experienced at assessing products under notice of potential litigation and negotiating favorable outcomes in litigation under Proposition 65.
- Home
- U.S. Federal Regulatory
- U.S. State Regulatory
- International Regulatory
- Science
- Compliance & Litigation Support
Affiliates: