On August 30, 2016, after two years of rulemaking, California’s Office of Environmental Health Hazard Assessment (OEHHA), the agency that administers California’s Proposition 65, adopted amendments to the Proposition 65 regulations that govern the “safe harbor” language deemed to be “clear and reasonable” and thus Proposition 65-compliant. The new standards provide consumers with more detailed information regarding potential chemical exposures. The new standards go into effect August 30, 2018. Until the effective date, warnings may use either the current warning language under existing 2008 regulations or the new warning language. Products manufactured prior to the effective date will not be subject to the new requirements, and warnings set forth in court-ordered settlements or consent judgments prior to the effective date will continue to be deemed “clear and reasonable” for the exposures covered by those judgments.
The prior safe harbor language for warnings on consumer products stated: “WARNING: This product contains a chemical known to the State of California to cause cancer and birth defects or other reproductive harm.” The amendments significantly change the safe harbor language. On-product labels for consumer products are now deemed to be clear and reasonable warnings if they use the following short-form warning language; the chemical at issue need not be specifically identified:
- For consumer products that cause exposures to a listed carcinogen, the words, “WARNING: Cancer – www.p65warnings.ca.gov.”
- For consumer products that cause exposures to a listed reproductive toxicant, the words, “WARNING: Reproductive Harm – www.p65warnings.ca.gov.”
- For consumer products that cause exposures to both a listed carcinogen and a reproductive toxicant, the words, “WARNING: Cancer and Reproductive Harm – www.p65warnings.ca.gov.”
Alternatively, the following long-form warning language may be used for an on-product warning, but one or more specific chemicals must be identified:
- For exposures to listed carcinogens, the words, “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.”
- For exposures to listed reproductive toxicants, the words, “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.”
- For exposures to both listed carcinogens and reproductive toxicants, the words, “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.”
- For exposures to a chemical that is listed as both a carcinogen and a reproductive toxicant, the words, “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 birth defects or other reproductive harm. For more information go to www.p65warnings.ca.gov.”
For catalogs and online sales of consumer products, the new standards also require warning language be in place.
In addition to changes to consumer product warnings, the new regulation also makes changes to area and environmental exposure warnings and prescribes requirements for some specific products and businesses.
The new standard also clarifies the responsibilities of manufacturers and other parties in the chain of distribution for consumer products. Specifically, even though a retail seller may still be found responsible for providing adequate warnings, liability of a retailer arises only under limited circumstances now. Under the new standard, the obligation to warn is clearly placed on product manufacturers, producers, packagers, importers, suppliers, and distributors. These parties must now either provide warning labels on their products or provide retailers with notice and warning materials.
If your company is modifying a consumer product or introducing a new product, now is a good time to consider updating your labels to be consistent with the new warning language ahead of time. Otherwise, be thinking about modifying your labels at some point in the next year or so to be ready when the new regulation takes effect in the summer of 2018. Further, if your company takes part in any portion of the manufacture or chain of distribution of a consumer product, including manufacture and supply, be aware that you may now be on the hook for complying with Proposition 65 labeling or notice requirements, even if you were not previously. There will likely be an uptick in the number of Proposition 65 notices and lawsuits once the new regulation takes effect, so companies should be aware of these changes and evaluate their warning obligations prior to the regulation’s effective date.
For more information on these Proposition 65 changes, contact Megan Caldwell, Amy Wachs, Charlie Merrill, or your Husch Blackwell attorney.