How chemicals are added to the Proposition 65 list
The Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) requires the State of California to publish a list of chemicals known to cause cancer or reproductive toxicity, and to update the list at least annually (Health and Safety Code section 25249.8).
The statute defines four ways for a chemical to be added to the Proposition 65 list.
1. Labor Code (LC)
At a minimum, the list must contain chemicals chemicals identified by reference in Labor Code section 6382(b)(1) or (d). Labor Code section 6382(b)(1) incorporates chemicals identified by the World Health Organization’s International Agency for Research on Cancer (IARC) as causing cancer in humans or laboratory animals.
- Figure showing process for listing via Labor Code mechanism
- Figure showing process for reconsideration via Labor Code mechanism
Either of two independent committees of scientific and health experts can find that a chemical has been clearly shown to cause cancer or birth defects or other reproductive harm. These two committees—the Carcinogen Identification Committee (CIC) and the Developmental and Reproductive Toxicant Identification Committee (DARTIC) — meet at least once each year and are designated as the “State’s Qualified Experts” for evaluation of chemicals under Proposition 65.
- Figure showing process for listing via SQE mechanism
- Figure showing process for reconsideration via SQE mechanism
3. Authoritative Bodies (AB)
The CIC and DARTIC have designated certain organizations as “authoritative bodies.” A chemical will be added to the Proposition 65 list if one of these authoritative bodies formally identifies it as causing cancer or birth defects or other reproductive harm.
The following organizations have been designated as authoritative bodies: the US Environmental Protection Agency, US Food and Drug Administration (US FDA), National Institute for Occupational Safety and Health, the National Toxicology Program of the US Department of Health and Human Services, and IARC.
- Figure showing process for listing via AB mechanism
- Figure showing process for reconsideration via AB mechanism
4. Formally Required to be Labeled (FR)
If an agency of the state or federal government requires that a chemical be labeled or identified as causing cancer or birth defects or other reproductive harm, it will be added to the list. Most chemicals listed in this manner are prescription drugs that are required by the US FDA to contain warnings relating to cancer or birth defects or other reproductive harm.
- Figure showing process for listing via FR mechanism
- Figure showing process for reconsideration via FR mechanism
Process for Listing and Delisting
Although Proposition 65 listing and delisting activities are expressly excluded from the requirements of the Administrative Procedure Act by Health and Safety Code section 25249.8(e), each procedure involves, at a minimum:
- Public notice that a chemical is under consideration for listing
- A public comment period
- Review of comments received
- Notice of the final decision
The figures describe OEHHA’s practice for listing and reconsideration. The specific procedures and criteria for listing differ somewhat for each mechanism. Each figure identifies the specific authority for that mechanism. The figures do not themselves have any mandatory or regulatory effect.