Upcoming regulation will change substantive components of Prop 65 warnings.
As discussed in Part 1 of Latham’s previous posts, California’s Office of Environmental Health Hazard Assessment (OEHHA) will modify how the department implements the Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65 (Prop 65) on August 30, 2018. In 2016, OEHHA published new regulations (the 2016 Regulations) for Prop 65 enforcement that will increase businesses’ responsibility to provide a “clear and reasonable” warning to consumers for products that contain carcinogens and/or reproductive toxins. OEHHA intended for the updated clear and reasonable requirements to improve access to information for California consumers considering purchasing products containing certain chemicals that the State designates as causing cancer or reproductive harm. As discussed in Part 2 of this series, the 2016 Regulations explain which businesses in the supply chain are responsible for each part of the Prop 65 warning process.
The 2016 Regulations require different warning content than earlier Prop 65 regulations, and also provide new “safe harbor language” which, if followed, are by regulation clear and reasonable. Cal. Code. Regs. tit. 27, § 25603(a). Distributors, suppliers, manufacturers, producers, packagers, and importers (Upstream Entities) will be responsible for developing warning content that complies with the 2016 Regulations before they become effective on August 30th. This blog post will discuss the new safe harbor content provided by the 2016 Regulations. The post is part of a continuing series on Prop 65 compliance issues for entities within the California chain of commerce to consider, as the new regulations become effective on August 30, 2018. The 2016 Regulations are only applicable to products manufactured on or after August 30th.
Summary of Changes to Chemical Specific Warning Requirements
Presently, companies are providing California consumers based on the existing generic Proposition 65 safe harbor warnings. For example, “WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.”
Under the 2016 Regulations, the term warning must now be presented in all capital letters and in bold font. Id. § 25603(a)(2). The warning must include a triangular symbol with an exclamation mark inside on the warning. Id. 25603(a)(1). The color of the triangular symbol depends on the rest of the sign, label, or tag. If the color yellow has not been used elsewhere, the triangle may be printed in black and white. Id. If yellow has been used on the label, sign, or tag, then the triangle must be printed in yellow with a black exclamation mark. Id. The warning must also list the OEHHA Prop 65 website url as part of the warning, in line with OEHHA’s goal of providing California consumers with more information prior to making a purchase. Id. § 25603(a)(2)(A−E).
If a consumer product results in an exposure, the safe harbor warning requirements of the 2016 Regulations require the warning label to identify at least one listed chemical for each endpoint, i.e., cancer and reproductive harm. Id. § 25603(a)(2)(A−E). The 2016 Regulations also provide different safe harbor warning requirements for products that contain solely carcinogens or solely reproductive toxicants, if the product contains chemicals listed for both carcinogens and listed reproductive toxicants, or if a chemical listed for both a carcinogen and reproductive toxicant.
Examples of sample warnings that satisfy the 2016 Regulations’ safe harbor requirements are below.
|Sample New Warning 1||Sample New Warning 2|
|WARNING: This product can expose you to chemicals including lead, which is 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/product.||WARNING: This product can expose you to chemicals including Bisphenol A (BPA), which is known to the State of California to cause birth defects or other reproductive harm. For more information go to www.p65Warnings.ca.gov/product.|
Under certain circumstances, particularly size limitations rendering use of the full safe harbor language impractical, use of a short-form warning may be appropriate. See id. § 25603(b).
The 2016 Regulations also include a “language other than English” requirement. If consumer product information is relayed in a language other than English, the Prop 65 warning must be repeated again in that language. Id. § 25602(d). If the two warnings are not presented together, the replicated foreign language warning will need to have its own triangular symbol. See OEHHA, Final Statement of Reasons. If the English and alternative language warnings are side-by-side, however, one triangle pictogram is enough. Id.
To prevent possible future claims of noncompliance with Prop 65, Upstream Entities should begin drafting new Prop 65 warning language and redesigning labels as needed to include all necessary information, symbols, and translations on-product.
For companies who choose to provide shelf signs, shelf tags, and other off-product warnings, it may be beneficial to contact applicable retailers and determine a format for Prop 65 warnings that is acceptable to both parties.
Any changes to product labeling will need to be applied to products or related signage for all products produced on or after August 30, 2018. If questions remain about the 2016 Regulations, please contact one of the authors or the Latham lawyer with whom you usually consult on similar issues.
This post was prepared with the assistance of Abby Timmons in the Orange County office of Latham & Watkins.