California Proposition 65: Omnibus Consumer Product Enforcement Act

California Proposition 65 LawThe California law known as Proposition 65, formally titled “The Safe Drinking Water and Toxic Enforcement Act of 1986,” can accurately be thought of as “Omnibus Consumer Product Enforcement Act.”  The law was enacted to improve public health by reducing exposure to toxic chemicals.  More specifically, Proposition 65 controls a growing list of chemicals and substances believed to have the potential to cause cancer, birth defects, or other reproductive adverse effects.  It is administered by the Office of Environmental Health Hazard Assessment, which is part of the California Environmental Protection Agency.  Proposition 65 requires businesses to notify Californians about significant amounts of chemicals in the products they purchase, in their homes or workplaces, or that are released into the environment.  These chemicals can include ingredients or additives in household or workplace products and foods, and can even include byproducts of chemical processes.

Since it was first published in 1987, the list has grown to include approximately 800 chemicals. For carcinogens, the toxicity of a chemical is based on no more than one excess cancer risk in 100,000 individuals exposed to that concentration of the chemical over 70 years.  For non-carcinogens, an additional 1000-fold margin of safety is applied to the more conventional benchmark for toxicity that is based on an exposure concentration shown to have no effect on humans or, more often, laboratory animals.

Once a chemical is listed, businesses have a year to comply with listing requirements, including posting warnings about toxic chemicals associated with their operations.  The warning requirement states that, “no person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual.”  Suppliers of food, water, and other exposure media are required to show that a properly applied method of detection and analysis was followed, where “method of detection and analysis” means a specific analytical testing procedure appropriate for detecting a particular chemical in a particular matrix such as air, water, soil, or food that is applied for the purpose of detecting the chemical or measuring its concentration (Section 12900 ARTICLE 9. MISCELLANEOUS, 22 CCR 12900).  This vague, circular language is an insufficient basis for identifying a concrete, technically valid testing regimen.  The supplier will likely need assistance from specialists to address this requirement.

Proposition 65 has established safety thresholds, also called safe harbor numbers, for some 300 listed chemicals based on conservative exposure assumptions, leaving about 500 chemicals currently without safe harbor numbers.  If a chemical is not listed, companies using such chemicals have the onus of developing exposure information.  Here again, the supplier will need assistance from specialists versed in the finer points of exposure assessment and analytical validity.  Vitale Scientific Associates, LLC provides expertise in the evaluation of sampling and analytical methodology.  We have assisted in litigation and laboratory evaluation for Proposition 65 cases and stand ready to support our clients through this challenging process.  A copy of the current Proposition 65 list can be found here.

For more information, please contact Quality Assurance Specialist David Thal at