OEHHA to Provide Clarifications to Article 6: Clear and Reasonable Warnings Under Prop 65
November 21, 2016 •
On Aug. 30, 2016, California’s Office of Environmental Health Hazard Assessment (OEHHA) adopted amendments to Article 6, Clear and Reasonable Warnings, of Prop 65. The regulation will be effective on Aug. 30, 2018. In the interim, OEHHA says businesses may comply with the old regulations until the effective date as companies will have two years to comply with the new regulations. Prop 65 requires anyone doing business in the state of California to provide a warning prior to exposure to a listed chemical(s).
A Prop 65 warning must be “clear and reasonable” under the law, and Article 6 provides safe harbor language that businesses can adopt to ensure compliance and protect them from enforcement. OEHHA has made significant changes to the Prop 65 regulations governing clear and reasonable warnings, including new safe harbor warning language and methods of transmitting warnings for product exposures, environmental exposures, exposures in the workplace, and specific safe harbor provisions from various sources such as amusement parks and parking garages. These amendments seek to accomplish Gov. Jerry Brown’s goals of improving the meaningfulness of warnings for the public and providing clarity for businesses required to warn under Prop 65. ACA has been actively participating in the regulatory process, providing substantive comments regarding its concerns with the agency’s numerous proposed revisions.
ACA is drafting guidance for members on the new Article 6 Requirements, and expects to release it in early 2017.
In the meantime, in order to provide greater clarity for its members, ACA sought clarification from OEHHA on several new requirements under the new regulations. Based on ACA’s consultation with OEHHA, ACA suggests the following guidance for members.
A number of ACA members have submitted questions to ACA regarding protocols for providing Prop 65 warnings on a safety data sheet (SDS). The questions include the following:
- Is an SDS a “safe harbor method of transmission” for a Prop 65 warning?
- Is a Prop 65 warning required to be on the SDS?
- If a company provides a Prop 65 warning on the product label, and wants to voluntarily put a Prop 65 warning on an SDS as well, how must this warning be provided?
ACA has confirmed that an SDS is not a “safe harbor method of transmission” for a Prop 65 warning. The safe harbor methods of transmission are listed in Article 6 under Section 25602 (i.e., internet, catalog, shelf tag, label, electronic device, etc.). In order to take advantage of the safe harbor, companies must warn in accordance with the safe harbor methods of transmission. Any warning provided on an SDS would be voluntary; it is not required.
Because an SDS is not a safe harbor warning method, companies that want to provide warnings on an SDS do not need to follow the safe harbor warning content regulations so long as there is a compliant Prop 65 warning using a safe harbor method of transmission. For example, if a company provides a Prop 65 warning on the product label, and wants to also voluntarily provide a warning on the SDS, the company may use the truncated warning on the SDS.
Regarding pictograms, ACA gained clarification on the following:
- Companies are recommended to use the “reasonable man” test to determine which color of yellow would trigger the need for the Prop 65 pictogram to also be in color.
- OEHHA has released images of the Pictogram online for businesses to use.
- Companies should view the product label as the “entire label” associated with the product. So, if the product has yellow on the front panel, it would trigger the color pictogram requirement even if the warning content is on the back panel or on a separate panel on the label.
Foreign Language Requirement
OEHHA indicated that it is currently developing safe harbor warning text for foreign languages. The agency will likely start with the nine languages included in the BPA Emergency Regulations and add to that list. These include Vietnamese, Tagalog, Korean, Hmong, French, Chinese, Cambodian, and Spanish.
Old vs. New Warnings
As the final regulations indicate, companies that are party to a court-ordered settlement or final judgment establishing a warning method or content are still deemed compliant with Prop 65 so long as they are complying with the settlement or final judgment. As such, even if the warning content is the old warning (i.e., no pictogram, no foreign language requirement, etc.), it is still “clear and reasonable” if it is prescribed in the court-ordered settlement or final judgment, and the company was a party to that judgment or settlement.
Blister packages are considered to be the “immediate packages,” and as such, the use of the shorter truncated warning on the blister card is allowed under the regulations.
There is no indicated preference on text formatting, other than type size.
Internet and Catalog Sales
“General advertising” or only displaying products either online or in a product catalog does not trigger the need for a Prop 65 warning. A warning would need to be provided online or in a catalog if the website has an e-commerce function, or if there was a method to purchase the product via a catalog.
To view the final Clear and Reasonable Warning regulations and more information, click here.
OEHHA has stated that it is planning to re-open the new regulations for Article 6, Clear and Reasonable Warnings, of the California Code of Regulations under Prop 65. The agency has said that it plans to revisit the rule to implement additional industry-specific warnings and to correct several minor drafting errors.