Editor’s Note: The way that chemicals get added to the list has not changed; however, the list of Prop 65 chemicals has. Here are some recently added chemicals that may be found in consumer products:
- Aloe Vera (non-decolorized whole leaf extract)
- Goldenseal root powder
- Nickel (soluble compounds)
- Perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS)
- TBBPA (tetrabromobisphenol A)
- Tetrachlorvinphos, and
- Vinylidene chloride (1, 1-Dichloroethylene).
With the exception of PCBTF (added on June 28, 2019) and Nickel (added on October 26, 2018), all of the aforementioned chemicals have all been added to the list at least 12 months ago, which means that products containing these chemicals must have required warnings if an exposure will be significant.
To determine whether Prop 65 impacts your company, the starting point is the Prop 65 chemical list. Knowing the listed chemicals and keeping up to date on new additions could mean the difference between facing a lawsuit or avoiding thousands of dollars in legal fees and settlement payments through advanced compliance.
Adding chemicals to the list
Under Prop 65, the Office of Environmental Health Hazard Assessment can add chemicals to the list in four ways. Once OEHHA identifies a chemical for possible listing, it initiates a regulatory process including public notice of intent to list, a public comment period, OEHHA’s review of any comments, and public notice of the final decision.
Listing by the state’s qualified experts mechanism
The Science Advisory Board is a group of expert scientists, appointed by the Governor, who determine whether unlisted chemicals are carcinogens or reproductive toxins.
There are two factions of the board: The Developmental and Reproductive Toxicant (DART) Identification Committee and the Carcinogen Identification Committee.
Although the two committees determine risks for different types of concerns, both follow the same process when making decisions about adding chemicals to the list:
- OEHHA staff scientists prepare hazard identification reports identifying scientific evidence showing a chemical’s carcinogenity or potential for reproductive harm. Once complete, the report is released for a 45-day comment period and the committee members review it.
- Committee members hear public testimony on the chemical and deliberate.
- If a chemical has been “clearly shown through scientifically valid testimony according to generally accepted principles” to either cause cancer or reproductive harm, OEHHA will add it to the list.
Listing by the authoritative bodies mechanism
The Science Advisory Board deems certain organizations “authoritative bodies.” If any authoritative body identifies a chemical as either causing cancer or reproductive harm, OEHHA may add it to the list. The Prop 65 regulations outline the process for adding chemicals through this mechanism and identify the following authoritative bodies:
- International Agency for Research on Cancer (solely as to transplacental carcinogenicity)
- National Institute for Occupational Safety and Health
- National Toxicology Program (solely as to final reports of the National Toxicology Program’s Center for Evaluation of Risks to Human Reproduction)
- U.S. Environmental Protection Agency
- U.S. Food and Drug Administration
Listing by the formally required mechanism
If a state or federal government agency requires that a chemical be labeled or identified as causing cancer or reproductive harm, OEHHA can add it to the Prop 65 list. OEHHA typically lists prescription medications requiring FDA warnings this way.
Listing by the Labor Code listing mechanism
If a chemical is identified as causing cancer or reproductive harm via one of the lists identified in California’s Labor Code, and meets listing criteria, OEHHA can add it to the list.
Updating the list
OEHHA must update the list at least once a year, but it is usually more frequent than that. We will post updated lists on a regular basis, including new listed chemicals and chemicals OEHHA intends to list. You can also review OEHHA’s California Regulatory Notice Register Notices, which provide public notice of potential and new listings.
Effect of new additions to the list
Prop 65 requires warnings for significant exposures to listed chemicals starting 12 months after OEHHA adds the chemicals to the list (this 12 month window is designed to allow for impacted companies to determine whether a warning is required). Private Prop 65 enforcers commonly issue a rash of notices of intent to sue (called “60-day notices,” discussed further in an upcoming post) for products shortly after the listing anniversary.
As a result, keeping up-to-date on listed chemicals for products you currently sell in California, or checking the list before entering the California market with a new product, is your first (and, perhaps, most effective) line of defense against Prop 65 enforcement actions.