California has adopted a new section to the State's Safe Drinking Water and Toxic Enforcement Act of 1986 (commonly known as Proposition 65), which establishes criteria for listing potential chemicals via the Labor Code. Proposition 65 requires the governor of California to publish, at least annually, a list of chemicals known to the State to cause cancer or reproductive toxicity.
The new Section 25904, which becomes effective Oct. 1, 2015, specifies that a chemical or substance shall be included on the list if it is "…classified by the International Agency for Research on Cancer (IARC) in its IARC Monographs series on the Evaluation of Carcinogenic Risks to Humans (most recent edition), or in its list of Agents Classified by the IARC Monographs, as:
- Carcinogenic to humans (Group 1), or
- Probably carcinogenic to humans (Group 2A) with sufficient evidence of carcinogenicity in experimental animals, or
- Possibly carcinogenic to humans (Group 2B) with sufficient evidence of carcinogenicity in experimental animals. A chemical or substance for which there is less than sufficient evidence of carcinogenicity in experimental animals and classified by IARC in Group 2B shall not be included on the list."
OEHHA first proposed adding Section 25904 on January 31, 2014, following a pre-regulatory public workshop and written public comment period, both of which took place in 2012. The regulation was modified four times in response to: comments received on the various versions of the regulation; court rulings (Styrene Information and Research Center v. Office of Environmental Health Hazard Assessment (2012) 210 Cal. App. 4th 1082 and Sierra Club v. Schwarzenegger (Brown) case (Case No. RG07356881)); and a Decision of Disapproval of Regulatory Action by California's Office of Administrative Law. Changes to the original proposal include:
- Deleting language stating that chemicals would remain on the Proposition 65 list pending committee review, even after OEHHA determined that a listed chemical no longer meets the requirements for listing; and
- Removal of a section specifying that a chemical shall be included on the Proposition 65 list if it is within the scope of the Federal Hazard Communication Standard.
For more information on earlier versions of the regulation, see the PackagingLaw.com article, California's Prop. 65 Labor Code Listing Mechanism Explained in Proposed Regulation. To view comments on the earlier versions of the regulation, and OEHHA's responses and reasons for modifications, see OEHHA's website.