On August 30, 2016, the California Office of Administrative Law approved California’s nearly three-year effort to overhaul Proposition 65’s longstanding warning regulations. The new regulations are a significant departure from the regulations that businesses have relied on for decades. Accordingly, they will require businesses to reassess and potentially overhaul their long-established compliance programs.
Proposition 65 requires businesses to provide “clear and reasonable” warnings before exposing individuals in California to any of over 800 listed chemicals. The regulatory amendment, promulgated by the Office of Environmental Health Hazard Assessment (OEHHA) makes significant changes to the decades old “safe harbor” warnings that business have relied on and which have been incorporated in thousands of Proposition 65 settlement agreements. The regulations provide for a two-year phase-in period. Although businesses are not required to follow the safe harbor warning regulations, other warnings lack presumptive validity and thus carry a greater risk of being challenged.
Some notable changes to the safe harbor warnings are as follows:
- Pictogram : All warnings except for food exposure warnings must contain a triangle symbol. The symbol may be printed in black and white if the sign, label, or shelf tag for the product is not printed using the color yellow.
- Identifying chemicals by name: If a warning is not provided on the product itself, such as on a shelf display or a store sign, a business must name at least one chemical for which the warning is being provided and specify whether that chemical is known to cause birth defects or reproductive harm, cancer, or both. This is a significant change. With the exception of warnings for alcohol, the prior safe harbor warnings do not require warnings to specify chemicals.
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, 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 more information go to www.P65Warnings.ca.gov.
- Truncated Warnings: The new regulations allow businesses to avoid specifying a chemical in their warnings, but only if the warning is provided on the product, contains the pictogram, and states the following for exposures to both a listed carcinogen and a reproductive toxicant: “WARNING: Cancer and Reproductive Harm - www.P65Warnings.ca.gov.” (This statement can mention only “Cancer” or “Reproductive Harm” if the warning is provided for only one of those endpoints.)
- Warnings after the point of purchase are prohibited: Warnings must be provided to consumers prior to or during purchase. This is also a significant change from the prior regulations, which, consistent with the Act, allow warnings to reach the consumer before exposure, i.e., use of the product. Warnings in operating manuals or inside of a boxed unit (such as slip sheets) would not meet this new requirement. It also means that if a product is sold online or in a catalog, the safe harbor warning must be given online or in the catalog.
- For internet sales, to meet the safe harbor, the warning must be provided on the product display page or prior to purchase, and the warning should be easy to find so that the consumer does not need to search for it.
- Link to OEHHA website: Warnings must include a link to the appropriate OEHHA Proposition 65 website based on the type of exposure.
- Other languages: Safe harbor warnings must be provided in English, and if a product sign, label, or shelf tag used to provide a warning also contains consumer information in a language other than English, the Proposition 65 warning must also be provided in that language.
The regulatory amendment also includes (1) tailored “safe harbor” warnings for over a dozen specific exposure scenarios, such as foods (including dietary supplements), restaurants, enclosed parking facilities, amusement parks, and designated smoking areas; (2) changes to warnings for environmental and occupational exposures; and (3) a statement that businesses may use alternative warnings so long as such warnings are deemed “clear and reasonable” by a court if challenged.
The new regulations are intended to implement only one part of Governor Brown’s 2013 reform initiative, which was to “improve how the public is warned” under Proposition 65. Unfortunately, the Governor’s call to curb litigation abuse has not achieved success, and the new regulations may actually make things worse. The prior safe harbor warnings have been quite workable, and the safe harbor warnings were rarely if ever challenged. However, the new regulations may result in a new type of litigation under Proposition 65 in which the adequacy of safe harbor warnings under the regulations is targeted.
Businesses that already provide Proposition 65 warnings, either under their own compliance programs or under a settlement agreement, should revisit their existing warnings in light of the new safe harbors and the pitfalls associated with the new regulations. Businesses that will provide warnings in the future will also need to review the new regulations if they want to provide safe harbor warnings and for useful guidance on what the agency considers to be a “clear and reasonable” warning that complies with Proposition 65’s amorphous requirements.