MLM Legal Perspective: Kevin Grimes: California’s Mysterious (and Infamous) Proposition 65 and What It Means for Your Products

Proposition 65 (the real name of which is the Safe Drinking Water and Toxic Enforcement Act of 1986) requires the State of California to publish a list of chemicals known to cause cancer, birth defects, or other reproductive harm.  This list has grown to include approximately 800 chemicals since it was first published in 1987.

Proposition 65 requires businesses to notify Californians about significant amounts of chemicals in the products they purchase.  The intent behind Proposition 65 is to enable Californians to make informed decisions about protecting themselves from exposure to these chemicals.

The list contains a wide range of naturally occurring and synthetic chemicals that are known to cause cancer, birth defects, or other reproductive harm.  These include ingredients in common household products, food, and drugs.  Listed chemicals may also be used in manufacturing, or they may be byproducts of chemical processes.

Businesses are required to provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone to a listed chemical. This warning can be given by a variety of means, such as by labeling a consumer product, posting signs at the workplace, distributing notices at a rental housing complex, or publishing notices in a newspaper. Once a chemical is listed, businesses have 12 months to comply with warning requirements.

Businesses with less than 10 employees are exempt from Proposition 65’s warning requirements.  Businesses are also exempt from the warning requirement if the exposures they cause are so low as to create no significant risk of cancer, birth defects, or other reproductive harm.

If a warning is placed on a product label, or the warning is posted or distributed at the workplace, the business issuing the warning is aware or believes that one or more listed chemicals is present.  By law, a warning must be given for listed chemicals unless exposure is low enough to pose no significant risk of cancer or is significantly below levels observed to cause birth defects or other reproductive harm.

California’s Office of Environmental Health Hazard Assessment (“OEHHA”) develops numerical guidance levels, known as “safe harbor numbers” for determining whether a warning is necessary.  A business has “safe harbor” from Proposition 65 warning requirements if exposure to a chemical occurs at or below these levels. OEHHA has established over 300 safe harbor levels to date and continues to develop more levels for listed chemicals.

If there is no safe harbor level for a chemical, businesses that expose individuals to that chemical would be required to provide a Proposition 65 warning, unless the business can show that the anticipated exposure level will not pose a significant risk of cancer or reproductive harm.  OEHHA has adopted regulations that provide guidance for calculating a level in the absence of a safe harbor level.  Determining anticipated levels of exposure to listed chemicals can be very complex.  Although a business has the burden of proving a warning is not required, a business is discouraged from providing a warning that is not necessary and instead should consider consulting a qualified professional if it believes an exposure to a listed chemical may not require a Proposition 65 warning.
