New to California Proposition 65? 

Here is a short summary.

Officially  known as the “Safe Drinking Water and Toxic Enforcement Act of 1986”  (or “Prop 65”), this regulation requires businesses to warn citizens of  California if their products or locations expose people to certain  levels of chemicals. 

The regulation is administered by the Office of Environmental Health Hazard Assessment (OEHHA), who maintains and updates a list of chemicals that may require warnings if exposures occur above certain thresholds (the “Prop 65  List”). Chemicals on the list are carcinogens (cause cancer) or reproductive/developmental toxicity, or both, and cover a wide range of chemicals, from heavy metals to certain drugs, solvents, residues, and others. 

Whether a product requires a Prop 65 warning depends on the level of exposure to listed chemicals on a daily basis from use of the product. If exposure exceeds the Safe Harbor Level (SHL) for that chemical, which is the daily exposure threshold that triggers a warning requirement, then a product warning would be needed. If exposure does not exceed the SHL, then no warning is required. 

More specifically, the SHL for carcinogens is called a No Significant Risk Level (NSRL), while the SHL for reproductive toxins is called a Maximum Allowable Dose Level (MADL). 

A very unique aspect of Prop 65 is that it is not enforced through OEHHA, but through civil litigation. So if a private citizen (typically assisted by a lawyer) allege that your product is not compliant with the regulation they will issue your company a “Notice of Violation” or NOV and can threaten to take your company to court. 

Court action can be avoided if the company agrees to “settle” with the enforcing party, which typically entails paying out a settlement fee (the average for 2017 was ~$40,000 USD/settlement), as well as complying with certain conditions, such as reformulation of the product or addition of product  warnings.  

So, if you sell a product into the state of California (or are upstream in the supply chain), then this regulation will likely apply, one way or another. However, the specific requirements may differ depending on where you are in the supply chain.

Once a product is alleged to be non-compliant, the plaintiffs will send out NOVs to many companies with similar products to try to profit from the lucrative settlement process. Companies caught unaware are likely more susceptible to paying higher settlements compared to those that have conducted their due diligence.

If you have questions about Prop 65 or what can be done to proactively address your company’s compliance, contact RegTox today!

Please follow and like us: