On January 12, 2015, California’s Office of Environmental Health Hazard Assessment (OEHHA) issued a proposed regulation to revise the required warning statement for products containing chemicals listed by the state under Proposition-65 (Prop-65). A link to the Prop-65 proposal can be found here.
In part, the proposal would require Prop-65 warnings to specify certain listed chemicals by name. Under the proposal, OEHHA would also establish a new website that would provide detailed information for the public about exposures to Prop-65 listed chemicals. The proposed revisions to Prop-65 warning requirements are the first substantive revisions to the law in over 30 years.
By way of background, California’s Prop-65 requires the State to publish a list of chemicals known to the State to cause cancer or developmental/reproductive toxicity. Under the law, businesses that market products or provide services in California that expose any person to a Prop-65 listed chemical above a specified threshold level are required to provide a “clear and reasonable” warning prior to such exposure.
In summary these new requirements would place a greater regulatory burden on industry to achieve full compliance with Prop-65 requirements. For example, under the proposal, the “clear and reasonable” warning statement would change from:
“This product contains a chemical (known to the State of California to cause cancer or developmental/reproductive toxicity)” — to — “This product can expose you to a chemical (known to the State of California to cause cancer or developmental/reproductive toxicity).”
Another key provision of the proposal would require the identification of the listed chemical in the text of the Prop-65 warning statement for exposures involving any of the following listed chemicals: acrylamide, arsenic, benzene, cadmium, carbon monoxide, chlorinated tris, formaldehyde, hexavalent chromium, lead, mercury, methylene chloride, and phthalates.
In addition, the proposal would also change the content and formatting requirements for Prop-65 warnings, as well as require use a warning pictograph in certain cases to help convey the warning statement. The proposal further includes requirements related to transmitting or posting Prop-65 warnings at retail locations, in catalogues, or on the Internet.
Finally, the proposal would require specific warning requirements for specified product categories (e.g., foods, alcoholic beverages, wood products, and other product categories).
Various industries have already expressed concern that the special labeling provision could spawn new litigation under State law. Further, Food and Drug Administration (FDA)-regulated industries believe aspects of the new Prop-65 labeling requirements may conflict with existing labeling requirements for drugs and medical devices. Another industry concern is whether the proposal will prevent manufacturers of multi-composite durable goods from providing a single Prop-65 warning statement in a product manual, rather than a separate warning for each listed chemical included in the product. Further, the proposal would also require that warnings be printed in multiple languages on product labels or signs that are printed in multiple languages. Thus, the proposal will clearly increase Prop-65 compliance costs across multiple industries.
The proposal includes a two-year implementation period to give industry time to comply with the new requirements. In the interim, OEHHA plans to hold a public hearing on the new labeling requirements on March 25, 2015. Interested parties can submit comments to OEHHA on the new Prop-65 proposal up until April 8, 2015.