California Proposition 65: Your Right to Know and More!
If you are a resident of California, or a visitor to the Golden State, you may have encountered the following warning: “This product contains chemicals known to the State of California to cause cancer, birth defects or other reproductive harm.” This warning is intended to inform individuals of potential harmful exposures they otherwise may not have been aware of prior to enactment of the Safe Drinking Water and Toxic Enforcement Act of 1986, known as Prop 65. If you see this warning on a product label or posted at a business, then you may be exposed to one or more of the over 900 listed chemicals determined by the State to cause cancer, birth defects or reproductive toxicity.
About Prop 65
The California Proposition 65 (Prop 65), is a “right to know” law administered by the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA). Prop 65 requires businesses to provide warnings to consumers and individuals who may be exposed to chemicals that cause cancer, birth defects or other reproductive harm. Any company with ten or more employees doing business in California is subject to Prop 65 including companies located outside of California. Prop 65 actions are enforceable in court, and penalties are assessed to companies in violation of the law. In addition to providing warnings, Prop 65 requires the State of California to publish a publically available list of chemicals known to cause cancer, birth defects or other reproductive harm. The law also prohibits California businesses from intentionally releasing significant amounts of listed chemicals into drinking water sources.
The Prop 65 List
The Prop 65 list is comprised of more than 900 naturally occurring and synthetic chemicals used in a wide range of applications including pesticides, household products, food additives, drugs, dyes, solvents, and byproducts of manufacturing and chemical processing.
There are four ways a chemical is added to the list: any chemical identified by:
- The World Health Organization’s International Agency for Research on Cancer (IARC) as causing cancer in humans or animals based on laboratory testing.
- “State’s Qualified Experts” from the Carcinogen Identification Committee (CIC) and the Developmental and Reproductive Toxicant (DART) Identification Committee (DART).
- CIC and DART-designated “authoritative bodies” including the U.S. Environmental Protection Agency (US EPA), U.S. Food and Drug Administration (US FDA), U.S. National Institute for Occupational Safety and Health (NIOSH), and the U.S. National Toxicology Program (NTP).
- State or federal government agencies (often employed by the US FDA for prescription drugs). Listed chemicals can be reconsidered, though the procedures and criteria for delisting differs depending on the manner in which the chemical was listed.
Safe Harbor Levels
According to the law, a warning is not required if it can be demonstrated that the exposure from a product occurs at or below established “safe harbor levels”. For cancer-causing chemicals, the exposure from a product must be sufficiently low to pose no significant risk of cancer assuming a lifetime of exposure. This safe harbor level is referred to as the no significant risk level (NSRL). For chemicals causing birth defects or reproductive toxicity, the exposure must be shown to have no observable effect with a 1000-fold safety factor. This safe harbor level is referred to as the maximum allowable dose level (MADL). While OEHHA has established safe harbor levels for many listed chemicals, safe harbor levels are not available for all listed chemicals. In the absence of a safe harbor level, businesses are required to calculate their own level for determining whether the anticipated exposure level will pose a significant risk of cancer or reproductive harm.
In August of 2016, OEHHA adopted new warning requirements under Prop 65. Beginning on August 30, 2018, the “clear and reasonable” warning must specifically name “one or more of the listed chemicals in the consumer product or affected area for which the warning is being provided,” as well as identify the specific endpoint associated with the chemical(s) (i.e., cancer, birth defects, and/or reproductive harm). In addition, warning labels will include the word “WARNING” with a symbol consisting of an exclamation point in an equilateral triangle. OEHHA also adopted new methods for providing warnings.
Other revisions include the option for providing warnings via “any electronic device or process that automatically provides the warning to the purchaser prior to or during the purchase of the consumer product, without requiring the purchaser to seek out the warning.” This revision requires websites and catalogues to provide warning text when no visible warning label is provided on the product available for purchase. Additionally, new regulations provide for product-specific exposure warnings for consumer products, food, alcoholic and non-alcoholic beverages, prescription drugs, dental care, petroleum products, and several other exposures. Lastly, OEHHA clarified that the manufacturer, producer, packager, importer, supplier, or distributor primarily is responsible for providing consumer product warnings, though retail sellers are responsible for placing and maintaining warnings.
OEHHA’s recently adopted regulations allow a two year grace period for businesses subject to Prop 65. However, with 2018 on the horizon, expect to see these new and improved warning labels on products and store signs.
A business has “safe harbor” from Prop 65 warning requirements if exposure to a chemical occurs at or below the safe harbor levels.
Intrinsik can help you understand your requirements under Prop 65, and we can offer advice on the following elements of the process:
- Review product formulations to determine the presence of product constituents on the current Prop 65 list
- Develop NSRL/MADL for chemicals with no OEHHA derived safe harbor number
- Utilize standard andaccepted exposure and risk assessment methods to conduct risk assessments and Safe Use Determinations for assistance with labelling decisions
- Assist with responses to plaintiff issued 60-day notices
- Provide expert advice in legal proceedings and in discussions and negotiations with plaintiffs, OEHHA and the Attorney General
For more information on how Intrinsik can help your company understand the requirement under Proposition 65, please contact Mr. Elliot Sigal, Senior Toxicologist and Vice President at 1-905-364-7800 or moc.k1544553616isnir1544553616tni@l1544553616agise1544553616.
Intrinsik Corp. Blogger: Alyssa J. Beltran, Environmental Health Scientist, Intrinsik Ltd., Venice Beach, California
- California Environmental Protection Agency (Cal/EPA). 2017. About Proposition 65. Office of Environmental Health Hazard Assessment. Retrieved from https://oehha.ca.gov/proposition-65/about-proposition-65
- Cal/EPA. 2017. Proposition 65 Warnings Website. Office of Environmental Health Hazard Assessment. Retrieved from https://www.p65warnings.ca.gov/