The California Office of Environmental Health Hazard Assessment (OEHHA) has published a notice of proposed rulemaking to repeal the current criteria for providing a "clear and reasonable" warning under Proposition 65 and adopt new regulations that would require more detailed information be provided about potential exposures to listed chemicals. Proposition 65—also known as the Safe Drinking Water and Toxic Enforcement Act of 1986—prohibits knowingly and intentionally exposing any individual to a listed chemical without first providing a "clear and reasonable" warning to such individual. OEHHA's warning regulations currently provide basic descriptions as to what would satisfy the "clear" and "reasonable" criteria, as well as "safe harbor" (non-mandatory guidance on methods by which to warn the public about possible exposures and general message content).
OEHHA states in its proposal that the existing regulations regarding the manner in which the warnings may be communicated are outdated, given the changes in technology that have occurred since the regulations were adopted more than 25 years ago. Furthermore, the existing requirements for safe harbor warnings lack the level of specificity that is required to ensure consumers receive useful information regarding potential exposures, according to the Agency. Accordingly, OEHHA's proposed regulations would, among other requirements:
- Prescribe specific methods for communicating warnings under Prop. 65, including the phrase that a person "can be exposed" to a listed chemical;
- Mandate the specific identification of a designated subset of Prop. 65-listed chemicals in the warning, including heavy metals; and
- Outline the responsibilities of commercial supply chain actors (manufacturers, distributors, producers, and packagers) versus retailers in California.
At this point, only a limited number of chemicals would be required to be explicitly identified in the text of the warning. These are: acrylamide, arsenic, benzene, cadmium, carbon monoxide, chlorinated tris, formaldehyde, hexavalent chromium, lead, mercury, methylene chloride, and phthalate(s). However, this list is certain to grow as nongovernment organizations and other interested parties urge OEHHA to include more chemicals.
Specifics of the Required Warning
The proposed regulations provide guidance on the required warnings for a variety of exposures, including exposure from products—both consumer and industrial—as well as environmental and occupational exposures. For product exposure warnings, the methods of transmission and content requirements are stipulated. The required warning for products was designed to increase the prominence of the warning. Specifically, a symbol consisting of a black exclamation point inside of a yellow equilateral triangle with a bold black outline would be required. The word "WARNING" in all capital letters and bold print also would be required. This symbol is not required on food products.
The proposal outlines a general warning message and more specific warning messages for certain products, The required warning message for food products, including any article used for food is: "Consuming this product can expose you to a chemical [or chemicals] known to the State of California to cause cancer and/or birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov/product."
For the 12 chemicals required to be included in the warning, the name of the chemical(s) would be required. For example: "WARNING: Consuming this product can exposure to a chemical such as acrylamide known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov/product." The link in the warning will be for a website that will be developed and maintained by OEHHA. The agency has proposed a separate regulation to establish the structure for this website, which will provide the public with supplemental information regarding exposures to listed chemicals.
Similar requirements for environmental and occupational exposures are specified in the proposal.
OEHHA will hold a public hearing on the proposed regulations on March 25, 2015. The regulations will become effective two years after adoption.