On January 8, 2021, California’s Environmental Protection Agency, Office of Environmental Health Hazard Assessment (OEHHA) issued proposed amendments to Article 6 of the regulations implementing the state’s Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65. These changes will require any company using short-form warnings to revise their labeling and marketing compliance plans.
Compliance with California’s Proposition 65 is a familiar hurdle for businesses selling consumer products into that state. Proposition 65 requires that consumers be provided with a “clear and reasonable warning” of exposures to certain chemicals determined by California’s Office of Environmental Health Hazard Assessment (OEHHA) to cause cancer, birth defects, or other reproductive harm. Manufacturers, distributors, and retailers who fail to provide such a warning are at risk for enforcement lawsuits from California’s Attorney General or the public at large, which place the burden of proof on the defendant business to demonstrate compliance. Substantial fees, as high as $2,500 per violation per day, can be incurred.
The warning for a product that can cause exposure to a carcinogen typically requires disclosure of one or more such chemicals. For example:
“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.”
Currently, under changes made in 2016, Prop 65 regulations (27 CCR § 25603) permit companies to use abbreviated “short form” warnings when the warnings are placed “on-product.” Many businesses gravitated towards these short-form warnings on both their products and websites, because the abbreviated warnings do not require disclosure of a listed chemical. For example, for a listed carcinogen:
“ WARNING: Cancer - www.P65Warnings.ca.gov.”
The rulemaking proposed on Jan. 8 would modify the existing short-form warning provisions as follows:
- Only allowing use of the short-form warning (a) on products with 5 square inches or less of label space, or (b) when the standard warning will not fit;
- Eliminating use of short-form warnings for internet and catalog warnings, even if a compliant short-form warning is used on the product itself;
- Clarifying how short-form warnings can be used for food products;
- Requiring that the name of at least one chemical be included in the short-form warning; and
- Requiring the words “risk” and “exposure” in the warning.
These changes are not surprising, given that OEHHA has previously expressed concern about the use of short-form warnings prophylactically even when businesses do not have actual knowledge of exposures to a listed chemical.
Amendments to the California Code of Regulations must be made in accordance with the California Administrative Procedures Act, which allows for a period of public comment on the proposed changes. Comments can be submitted online at https://oehha.ca.gov/comments until Mar. 8, 2021.
Once the comment period on the proposed regulations closes, OEHHA will issue a final regulation. The changes to the short-form warnings would take effect one year after issue of those final regulations. The amendments also include a “sell-through” provision, whereby the warning changes would not apply to products manufactured prior to the effective date.
If you have any state or federal regulatory compliance questions, including questions relating to California’s Proposition 65, please contact the authors of this alert or the Womble Bond Dickinson attorney with whom you normally work.