On Friday, August 30, 2016, California's Office of Environmental Health Hazzard Assessment (OEHHA) finalized new regulations for "Clear and Reasonable Warnings" under the state's Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). Proposition 65 requires, among other things, that businesses with 10 or more employees give a clear and reasonable warning to individuals before knowingly and intentionally exposing them to a chemical listed (by OEHHA) as known to cause cancer or reproductive toxicity. Importantly, the new regulations retain the "safe harbor" concept by giving a business the opportunity to use warning methods and content that OEHHA has deemed "clear and reasonable," or, in the alternative, to use another warning method that is clear and reasonable under this regulation. Essentially, OEHHA intends that these new regulations will address a perceived lack of specificity with the safe harbor warnings, and account for new technologies (i.e., internet-based sales) and the increased prevalence of foreign languages spoken by California's population.
The regulation must be complied with by August 30, 2018. Until this date, both the old and new clear and reasonable warning regulations may be used.
This client alert discusses the most striking changes to this regulation. The full revised regulations can be found here.
Product Manufacturers/Distribution Chain vs. Product Retail Seller
OEHHA's revised regulation attempts to minimize the burden on retail sellers of consumer products. As such, the manufacturer, producer, packager, importer, supplier, or distributor of a product is primarily responsible for compliance with these regulations. This can be accomplished either by affixing to the product a label with the appropriate warning language, or by providing a written notice directly to the authorized agent for a retail seller (thereby shifting the burden to the retail seller to provide the warning to consumers). Please note that if written notice to the retailer is the method used, the regulations require specific information be provided to the retail seller. However, retail sellers are not completely exempt from responsibility. For example, if the retail seller itself is responsible for introducing a listed chemical into the product, if the retail seller is selling a product under a brand or trademark they own, or if the retail seller has covered the warning language appearing on a product label, then the retailer is responsible for providing the warning to consumers.
Methods and Content for Safe Harbor Warnings
Warnings are clear and reasonable, and thus eligible for the safe harbor, only if all of the applicable requirements of the regulation are met. Notably, the regulations now require the name of the specific chemical to be included in the warning. Additionally, when a warning is provided for more than one endpoint (cancer and reproductive toxicity), the warning must include the name of one or more chemicals for each endpoint (unless the same chemical applies to both).
The actual warning must be prominently displayed on the label, labeling, or sign, and must be conspicuous so that the warning is "likely to be read and understood by an ordinary individual under customary conditions of purchase or use." In addition to the below specific exposure warnings, all must include a symbol with a black exclamation point in a yellow equilateral triangle with a bold black outline to the left of the statement "WARNING." However, if the label is not printed using the color yellow, the symbol may be printed in black and white.
The new safe harbor warning language for consumer products includes the following:
- Carcinogens: "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."
- Reproductive toxicants: "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 exposures to more than one chemical, where the chemicals are listed both as carcinogens and reproductive toxicants: "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, and [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm."
- For exposures to one chemical that is listed as both a carcinogen and a reproductive toxicant: "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 and birth defects or other reproductive harm."
- For food exposures, including dietary supplements, the language is modified slightly to begin "Consuming this product can expose…," and the website is changed.
For more information, visit www.P65Warnings.ca.gov.
Internet-Based Sales
For internet purchases, a warning must be provided by including either the necessary warning language or a clearly marked hyperlink using the word "WARNING" on the product display page, or by otherwise prominently displaying the warning to the purchaser prior to completing the purchase. OEHHA specifically states that a warning is not prominently displayed if the purchaser must search for it in the general content of the website.
Foreign Language
The new regulations require that when a consumer product sign, label, or shelf tag 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.
The final regulation provides a number of exemptions and specific examples, and Venable encourages individuals with specific questions to reach out to one of the authors of this client alert.