After two years of debate, the California Environmental Protection Agency’s (Cal/EPA’s) Office of Environmental Health Hazard Assess- ment may soon modify Proposition 65, the state law regulating chemicals alleged to cause cancer, birth defects or reproductive harm. After holding a public hearing in March 2015 and closing the public comment period in April, the office is likely to soon finalize its proposed changes to regula- tions that govern “clear and reasonable” warnings for Prop. 65 chemicals. These changes could have a major impact on dietary supplement and cosmetic manufacturers and retailers.
Prop. 65—officially the Safe Drinking Water and Toxic Enforcement Act of 1986—requires the state to annually publish a list of chemicals that can have a toxic effect on humans. There are currently more than 900 chemicals on the list. The statute also makes businesses responsible for warning consumers if their products contain any of the listed chemicals. If a manufacturer or retailer fails to provide a “clear and reasonable warning” on a label or in a store, the business may face an enforcement action brought by the state attorney general or private citizen suits, which seek statutory penalties and attorney’s fees. Critics of the changes warn that the proposed revisions could encourage more “bounty hunter” plaintiff suits.
Cal/EPA has proposed modifying the general warning that is now required so that if a product contains one of the so-called “Dirty Dozen” chemicals, the warning must specifically mention that chemical. These 12 chemicals include acrylamide, arsenic, benzene, cadmium, carbon monoxide, chlorinated Tris, formaldehyde, hexavalent chromium, lead, mercury, methylene chloride, and phthalates. The new regulation would also mandate that warning labels direct consumers to a stand-alone website maintained by the environmental agency.
Online sellers of products must “prominently” display a hyperlink warning to a purchaser before the sale is completed. The changes also attempt to minimize the burden on retailers by making manufacturers primarily responsible for warning consumers about potential chemical exposures. Retailers, however, must still provide a Prop. 65 warning if the product is being sold under a brand or trademark licensed by the retailer, if the retailer “knowingly and intentionally” introduces a listed chemical into the product, if the retailer covers or alters the warning label provided by the manufacturer, if the retailer has actual knowledge of potential exposure, or if the manufacturer or importer of the product cannot be compelled to comply with Prop. 65 because they are foreign entities. Finally, the revised regulations expressly include dietary supple- ments under the statutory definition of a food product and give specific examples of the content required for warnings on supplements and food.
The state is expected to act soon to adopt these regulatory changes before its January 2016 deadline. Businesses would have two years to comply with the new warning requirements.