Proposition 65 Regulation (California)

Proposition 65 Regulatory Overview

Proposition 65, formally known as the Safe Drinking Water and Toxic Enforcement Act of 1986, was passed as a voter initiative with the purpose of protecting California citizens and the State’s drinking water sources from exposure to toxic chemicals. Proposition 65 requires California to publish a
list of chemicals “known to the state” to cause cancer, birth defects or other reproductive harm. The list has grown to include roughly 800 chemicals since it was first published in 1987.

Once a chemical is listed, businesses must provide “clear and reasonable” warnings to those exposed in California and are prohibited from discharging it into drinking water, unless exposures are shown to be “insignificant.” The “significance” of potential exposures is determined by comparing them to allowable exposure levels, commonly called
 Safe Harbor Levels, or more specifically, No Significant Risk Level (NSRL) for carcinogens and the Maximum Allowable Dose Level (MADL) for chemicals causing reproductive harm. Proposition 65 affects every company conducting business in California, whether by manufacturing or distributing products for sale in the State or by operating businesses at facilities within the State.

Proposition 65 Enforcement

Proposition 65 may be enforced in California courts by public prosecutors, including the California Attorney General, district attorneys and certain city attorneys, or by any private individuals or groups acting “in the public interest.” Proposition 65 is enforced by litigation with the burden of proof placed on businesses rather than the plaintiff. Before a lawsuit is filed, a notice of the alleged violation must be sent to the business 60 days prior to the filing. This is known as a 60-day notice letter, during which the Attorney General may take over the case. Public prosecutors do not need to send 60-day notices. Because Proposition 65 is not enforced by a government agency, a business should seek
legal advice upon receiving a 60-day notice letter. Violators are subject to civil penalties.

Proposition 65 Services

With more than 25 years of experience working with the intricacies of Proposition 65, TSG’s consultants provide a unique advantage to companies dealing with a Proposition 65 issue. Our staff is experienced in all aspects of Proposition 65, including:

▲ Listing/Delisting: Coordinating efforts involving proposed addition of compounds onto the Prop 65 list or, once listed, efforts to remove chemicals from the list;

Proposition 65 Risk Assessment: Developing underlying documentation to support an assessment;

Safe Harbor Levels: Determining Safe Harbor Levels when a default level has not been established by California’s Office of Environmental Health Hazard Assessment (OEHHA);

▲ Providing guidance on the significance of exposures and follow-up support, as necessary; and

 Pre-Trial Technical Support: Providing pre-trial support for Prop 65 litigation.

Text fileCurrent Proposition 65 List: View PDF version