Winter 2021

Guest Editorial: California’s Proposition 65: The Ultimate Product Stewardship Law

By Carol Brophy, Esq., Steptoe & Johnson LLP

Proposition 65 has created a cottage industry of private enforcers who initiate actions against hundreds, if not thousands, of businesses each year.

The Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65 (“Prop 65”) after the name of the ballot initiative, demands constant vigilance from every business whose activities, products, or services may find their way into the State of California.  Prop 65’s power lies in its simplicity and its uniqueness.  It establishes a list of chemicals “known to the State of California” to cause cancer and reproductive toxicity, which currently exceeds 900 substances, and regulates these chemicals by (1) prohibiting discharges into sources of drinking water and (2) requiring warnings to individuals prior to human exposure.

Proposition 65’s power lies in its simplicity and its uniqueness.”

Prop 65 applies to all products or processes containing, emitting, and/or producing any detectable amount of a listed chemical.  It places the burden on the defendant to prove the exposure at issue is below statutory risk levels.  (This determination requires an exposure assessment according to California’s unique requirements and methodology – which differ, often markedly, from federal risk assessments.)  Prop 65 is enforced through lawsuits filed in state courts by public prosecutors and private enforcers.  Prop 65 violations are punishable by civil penalties of up to $2,500 per violation, per day.  If successful, private enforcers keep 25% of any civil penalty and are reimbursed their attorney’s fees and cost.  This has created a cottage industry of private enforcers who initiate actions against hundreds, if not thousands, of businesses each year.  The value of the private settlements in 2018 alone was $35,169,924.

The key to Prop 65 compliance is robust product stewardship, based on a complete understanding of the law and the identification of the listed chemicals that may be present in every aspect of production and in the final product or services the company provides.  We recommend that each company have a written Prop 65 Compliance Program that is integrated into every aspect of the business with emphasis on legal, purchasing, uality/assurance (Q/A) operations, research & development (R&D), and marketing.  

To implement the program, recommended best practices include:

  • Designating a team or at least one responsible individual.
  • Conducting a Prop 65 Audit.
    • Know what materials and products contain listed chemicals, with special attention to those chemicals that are contaminants at low levels.
      • Which are found in your ingredients/components/processing aids?
      • Which are formed during manufacturing/packing/processing?
      • Which may be found in packaging?
    • Perform a screening exposure assessment to identify if the product or service will cause an exposure that may require a warning or pose a litigation risk.
    • Determine whether you can reformulate, modify production, or otherwise remove or reduce the listed chemical.
      • Provide a warning if necessary. (Warning programs have their own challenges and require careful management.)
    • Have a plan for working with others in the stream of commerce. Communication with suppliers, brokers, and customers is important for success.

California maintains a Prop 65 website at  

Contact Info

Carol Brophy heads Steptoe & Johnson’s Proposition 65 practice and is recognized as a leading Proposition 65 defense attorney. For more information email