Updating our prior post, California’s Office of Environmental Health Hazard Assessment issued new proposed regulations on clear and reasonable warnings for Proposition 65. This proposed regulation follows March and September drafts that were subject to public and stakeholder input. The current draft is similar in substance to the September iteration, leaving unchanged many of the business community’s significant concerns. OEHHA will conduct a public hearing on March 25, 2015, and the public comment period is open until April 8, 2015.
Safe harbor warnings
The proposed regulation maintains the safe harbor approach (reversing the mandatory warnings proposed in the March draft). The draft provides specific warning methods and messages constituting safe harbors, but allows businesses to use other warnings as long as they comply with Section 25249.6.
The prior draft contained a provision specifically grandfathering in warnings previously approved in settlements or court judgments. The current draft drops this language because it is subsumed by the provisions allowing parties to provide warnings that comply with Section 25249.6.
Warning Language
The proposed regulation tweaks the last draft slightly, requiring the following language to fall under safe harbor protections:
“WARNING: This product can expose you to a chemical [or chemicals] known to the State of California to cause [cancer]/[birth defects or other reproductive harm]. For more information go to www.P65Warnings.ca.gov.”
If the product contains any of the following chemicals, the chemical name must also be provided in the warning:
- Acrylamide
- Arsenic
- Benzene
- Cadmium
- Carbon monoxide
- Chlorinated tris
- Formaldehyde
- Hexavalent chromium
- Lead
- Mercury
- Methylene chloride
- Phthalates
In addition, safe harbor warnings must meet the following requirements:
- All warnings must include a triangle with exclamation point.
- For on-product labeling, unless otherwise prohibited by federal law, the warning language must be enclosed in a box, be in specific font sizes, and can include truncated warning messages.
- All warnings must be legible and conspicuously printed and must be provided in a manner likely to be seen by the consumer.
OEHHA website
OEHHA originally proposed a website containing information that manufacturers would be required to provide regarding the chemicals in their products, as well as routes and magnitude of exposure. After much opposition, OEHHA has dropped that proposal.
OEHHA has replaced it with a separate proposed rulemaking for an OEHHA website to collect and provide information to the public concerning exposures to listed chemicals, including links to administrative entities that may provide information on the subject, listing of information concerning levels of human exposure and other more specific information for exposures from food products.
The proposed website regulation also requires manufacturers and distributors to provide OEHHA with certain information upon request “when reasonably available.” Such information includes identifying chemicals for which warnings are given, the location of a chemical in a product, concentration, routes of exposure, and exposure levels. Notably, failure to comply with an OEHHA request will not be deemed a violation of Prop 65.
Retailer obligations
As with the previous proposals, the current draft attempts to allocate warning responsibility to the manufacturer, distributors, and importers, with retailers only responsible under the following conditions:
- The retailer sells its own private label product;
- The retailer knowingly and intentionally introduced a listed chemical into the product, or caused a listed chemical to be created in the product;
- The retailer covered, obscured or altered a warning label already affixed to the product;
- The retailer received warning information and materials (or an offer to provide warning materials) for the exposure from the manufacturer and the retailer sold the product without conspicuously posting those warning materials; or
- The retailer has “actual knowledge” of the potential product exposure requiring the warning, and the manufacturer, distributor, importer, or packager are all (a) exempt from Prop 65, and/or (b) foreign entities with no agent for service of process.
“Actual knowledge” and opportunity to cure
The draft defines “actual knowledge” as “specific knowledge of the product exposure that the retailer receives from any reliable source,” and if the source of the knowledge is a 60-day notice, the retailer does not have actual knowledge of any alleged exposure until two business days after receiving the notice.
In the Initial Statement of Reasons for the proposed regulation, OEHHA explains that this means that a retailer with no actual knowledge of a potential exposure prior to receiving a 60-day notice has “a two business-day period after receipt of the notice … to either post a warning or pull the product to avoid causing a knowing and intentional exposure.”
This reflects a change from the September draft, which put the language regarding knowing and intentional exposure directly into the regulation. However, OEHHA has made it clear that retailers have an opportunity to cure if they have no prior actual knowledge.
