Proposition 65 (California)

California’s Safe Drinking Water and Toxic Enforcement Act of 1986, known as Proposition 65, requires the state to publish a list of chemicals known to cause cancer, birth defects, or other reproductive harm. Today, this list contains over 950 chemicals and has far reaching implications beyond California. Proposition 65 affects most industries, including food, drugs, consumer products, cosmetics, agricultural products, medical devices, workplaces, and commercial businesses. Companies doing business in California are required to provide warnings to anyone who may be exposed to any of these compounds, by any route, and discharging these compounds into drinking water is prohibited. Most importantly, Proposition 65 is enforced through litigation: The penalties for not providing warnings are $2,500 per day, per individual product and exposure, so the cost of litigation is highly significant.

Once a chemical is listed under Proposition 65, businesses have twelve months to comply with warning requirements through labeling, posted signs, and publications and twenty months to comply with the prohibition on discharging listed chemicals into sources of drinking water. Warnings are not required provided the manufacturer has conducted an exposure and risk assessment that proves that the level of exposure is less than an amount that would pose a significant risk (Safe Harbor Level). Proposition 65 does not ban any products, nor is it a true assessment of potential health risks; rather, it requires warnings instead. Compliance is complicated in that the limits for identified chemicals can vary for compound and product. Product limits are often established based on settlements resulting from prior litigation from individual or groups challenging the warning requirements. At Exponent, we work with clients to address a variety of Proposition 65 issues including:

  • New 2018 Warning Requirements – Deadline August 2018
  • Listing/delisting of chemicals
  • Safe Harbor Level (NSRL and MADL) – develop new levels and establish within regulations
  • Litigation support – guidance through law that is enforced through litigation
  • Safe Use Determinations (SUD) – petitions, advocacy, science, and process management
  • Interpretive Guidelines (IG) – propose and establish through OEHHA
  • Individual Product Compliance – assessment and records of diligence
  • Entire product Line – review & establish compliance operating procedures
  • Proposition 65 compliance oversight
  • Sampling of products including food market basket studies
  • Exposure and risk assessments including worker, consumer, and environmental exposures



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