What is the Clear and Reasonable Warning Requirement Established by California’s Prop 65?
California Prop 65 requires all parties associated the manufacture, distribution or sale of a consumer or commercial product to provide a Clear and Reasonable Warning before exposure to any of the more than 800 chemicals specified on the Prop 65 list. The chemicals listed within the regulations include many chemicals, compounds, additives or ingredients present in many commercial, consumer and household products including but not limited to:
- Over-The-Counter Drugs
- Bicycles and Helmets
- Rugs and Floor Coverings
- Beverages Including Craft Beer Production
According to Prop 65 regulations, a warning can appear on the product itself, the product’s label or other packaging or may consist of identification of the product at the retail outlet or online advertisement through compliant content, shelf labeling, signs or menus or a combination thereof. “The method employed to transmit the warning must be reasonably calculated, considering alternative methods available under the circumstances, to make the warning message available to the individual prior to exposure.”
Prop 65 establishes the Clear and Reasonable Warning “must clearly communicate that the chemical(s) in question is known by the State of California to cause cancer, birth defects or other reproductive harm.” The warning for consumer products must include the “methods of transmission and the warning message as specified” under Prop 65.
A common example of a Clear and Reasonable Warning would be:
“This product contains lead, a chemical known to the state of California to cause cancer.”
There are Some Exemptions and Safe Harbors Under Prop 65
The OEHHA has provided Safe Harbor numbers for many of the chemicals on the list. For example, a warning is not required if it can be proven that ”no significant risk” is presented by a carcinogen or that chemicals causing birth defects would show ”no observable effect” at 1,000 times the level of exposure.
For cancer risks the “No Significant Risk Level (NSRL) is the level of exposure that would result in not more than one excess case of cancer in 100,000 individuals exposed to the chemical over a 70-year lifetime.
For birth defects, the “no observable effect” level is determined by identifying the level of exposure that has been shown not to pose harm to humans or laboratory animals. This “no observable effect” level then has to be divided by 1,000 to obtain the Maximum Allowable Dose Level (MADL).
For chemicals for which no Safe Harbor number exists, it is up to the business to prove that exposure falls within an exemption.
Contact Experienced California Proposition 65 Compliance and Litigation Defense Attorneys
Are you concerned about coming into compliance with California Prop 65 as a manufacturer, distributor, retailer, catalog house or online point of sale for consumer products and commercial goods sold within the State of California? How can you provide a Clear and Reasonable Warning and ensure compliance with all regulations under this complex statute? Is there a Safe Harbor, Safe Use Determination or SUD, or Naturally Occurring Exemption which would reduce your exposure to litigation and financial consequences under Prop 65? What should you do if you receive a 60 day Notice or are served papers regarding a lawsuit? We invite you to contact us or call 866-631-3470 for a free consultation with an experienced California Prop 65 compliance and litigation defense attorney. Learn how we can help you to avoid costly Prop 65 financial liabilities and protect the profitability of your business.