On August 31, 2016, California took a long-awaited step in publishing new major changes to the Proposition 65 warning regulations; the first of such amendments in more than a decade. The wholesale changes completely alter the “safe harbor” warning rules, creating a new set of obstacles for companies offering products or operating facilities in California. Although the new regulations are intended to increase clarity and decrease litigation, they may actually have the opposite effect.
Proposition 65, known as the Safe Drinking Water and Toxic Enforcement Act of 1986 requires that businesses with 10 or more employees provide a clear and reasonable warning to individuals before knowingly and intentionally exposing them to a chemical known to cause cancer or reproductive toxicity. The infamous Proposition 65 list now contains more than 900 such chemicals under strict regulation by governmental agencies and plaintiff consumer watchdog groups, commonly known as “bounty hunters.” The Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency that implements Proposition 65, maintains the Proposition 65 list, and has authority to amend the regulations to further the purposes of the Act. In adopting the changes, OEHHA determined that the safe harbor warnings needed more detailed information for the public as well as to incorporate changes in technology and to communicate more effectively with non-English speakers.
The new rules become operative on August 30, 2018, providing businesses with a two-year transition and preparation period. Until then, companies must comply with the current regulations which provide that a warning is “clear” if it clearly communicates that the product contains a chemical known to the State of California to cause cancer, birth defects, or other reproductive harm. Under current regulations, the warning is deemed “reasonable” if the method employed to transmit the message is reasonably calculated to make the warning message available prior to the exposure. Companies may also comply with the current warning regulations if they are a party to an out-of-court settlement or court-approved consent judgment which establishes a warning method or content, and the companies comply with those requirements.
The new warning rules have been closely monitored by businesses, consumer advocacy groups, and regulators, among others. The final version of the warning regulations, which were published after OEHHA’s consideration of over 70 written comments, remains controversial. The new safe harbor rules have the following key changes which are more onerous than the current regulations, except as to retail sellers:
- Warning symbol: The addition of a symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline for nonfood products while retaining the signal word “WARNING”:
- “Can expose”: Additional language in the warning statement that the product “can expose” an end user to chemicals known to the state to cause cancer. The current regulation only requires that the warning state that the product “contains” a chemical. A comparison of the existing warning and new warning for products that can expose consumers to chemicals known to cause cancer is set forth below:
|Exemplar Existing Warning (Cancer)||New Warning (Cancer)|
|“WARNING: This product contains a chemical known to the State of California to cause cancer.”||“WARNING: This product can expose you to chemicals, including [name of one or more chemicals], which is [are] known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.”|
- A similar warning is required for products that “can expose” a user to chemicals known to the state to cause reproductive toxicity. A comparison of the existing warning and new warning for products that can expose consumers to chemicals known to cause reproductive harm is set forth below:
|Exemplar Existing Warning (Reproductive Toxicity)||New Warning (Reproductive Toxicity)|
|“WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.”||“WARNING: This product can expose you to chemicals, including [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.”|
- Identification of chemicals: The identification of one or more chemicals for each endpoint (cancer or reproductive harm) within the warning, except where the warning is affixed to the product itself;
- Hyperlinks: The addition of a URL to all warnings linking to a public website operated by OEHHA to provide information supplementing the warning for interested consumers and others, such as plaintiff’s lawyers and consumer advocacy groups;
- Internet purchases: For internet purchases, the warning must be provided on the product display page or on a clearly marked hyperlink using the word “WARNING;”
- For food products, including dietary supplements, new requirements to enclose the warning in a box and set it apart from other label information;
- Additional languages: If a consumer product, sign, or label used to provide a warning includes consumer information in a language other than English, the warning must also be provided in that language in addition to English;
- Retailers: The new rules continue to minimize the burden of warning on retail sellers and limits the specific instances where retailers must provide such warnings (e.g., where the retailer sells a product under a brand or trademark owned or licensed by the retailer or an affiliated entity); and
- Miscellaneous new rules: Special rules for alcoholic beverages, canned and bottled foods and beverages that contain bisphenol A, parking facilities, and amusement parks.
The new warning rules place additional burdens on companies manufacturing and selling consumer products in California by requiring new, more specific content and formatting, and extending into specific products and industries not previously regulated. While the new regulations are intended to decrease litigation in this area, companies may find themselves the target of additional violation notices and lawsuits as plaintiff “watchdog” groups search for any slight noncompliance with the technical, detailed new warning requirements. By understanding the new requirements now, businesses can proactively prepare themselves for full compliance by the effective date.