California Proposition 65
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 them to certain levels of chemicals. For consumer products, this is typically accomplished with on-product warnings, although signs are used at the entrances of certain places of exposure.
The regulation is administered by the Office of Environmental Health Hazard Assessment (OEHHA), which maintains and updates a list of chemicals that may require warnings if exposures occur (the “Prop 65 List”). There are about 900 chemical on the list and they listed as carcinogens (cause cancer) or reproductive/developmental toxins, or both. Substances on the list cover a wide range of chemicals, from heavy metals to certain drugs, solvents, residues, pesticides, 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. 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).
How is it different from other regulations?
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) alleges that a product is not compliant with the regulation (i.e., product does not have a warning, but should), they will send the company a Notice of Violation or “NOV”, with the threat of taking them to court.
Legal action can be avoided if the defending company agrees to “settle” with the enforcing party, which typically entails paying out a settlement fee (the average for 2018 was ~$40,000 USD/settlement). As well, the company must agree to certain conditions, such as reformulation of the product, periodic testing, and/or addition of product warnings.
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 unprepared are more susceptible to paying higher settlements compared to those that have conducted their due diligence.
Which companies must comply with Prop 65?
Practically speaking, this regulation applies to any company selling almost any product into California, whether through retail outlets or online marketplaces. The only relevant exceptions are companies with less than 10 employees; however, customers may still inquire into the Prop 65 compliance status of your product, due to liability concerns, and therefore, small businesses must essentially still investigate and understand their compliance. Products that are exempt include such things as pharmaceuticals.
And not just the entities introducing the final product must be aware of Prop 65 compliance, but the entire supply chain can be implicated. Therefore, even if your intermediate components, plastics, coatings, textiles, etc., end up in California, your company may still face questions about Prop 65.
If you have questions about how to address Proposition 65, contact us today – we provide comprehensive solutions at competitive rates to reduce the stress of compliance.