California's Office of Environmental Health Hazard Assessment (OEHHA) took another step toward revising the Article 6 Clear and Reasonable Warning Requirements under Proposition 65 (Prop 65) by issuing a new proposed rule on March 25, 2016. This proposal is just the latest in a series of potential revisions, which includes a January 2015 version that was withdrawn and replaced by OEHHA last November. Whereas the January 2015 draft had proposed specific warnings for the so-called "dirty dozen substances," OEHHA now proposes to require that at least one chemical be named if any warning is required to be provided. The proposed rule provides a two-year grace period for compliance.
Underlying the requirement to identify specific chemicals is an effort to address the issue of over-warning. Under the current Prop 65 regulations, in order to avoid litigation risk, a manufacturer may include the generic cancer or reproductive toxicity warning on a product, even when it does not know whether a Prop 65-listed chemical is in the product or has not determined that the chemical is below the no observable effect level (NOEL). Such over-warning is common in the face of potential Prop 65 litigation, though arguably contrary to the intended regulatory purpose of the Article 6 warning requirement. By requiring the identification of chemicals on the Prop 65 warning, manufacturers arguably would be precluded from using blanket statements and would have to more precisely understand what Prop 65 chemicals are contained in their products. This change could prompt additional due diligence of manufacturers' supply chains and product composition.
The proposed regulatory language also can be read to force manufacturers to engage in the costly analysis of determining NOELs for Prop 65-listed chemicals in their products because it requires warnings for chemicals "for which the person has determined a warning is required." Critics have long complained about the burden of establishing a NOEL for a chemical, especially as OEHHA is substantially behind in determining safe harbor levels for listed chemicals. Moreover, there is no guidance provided with respect to any hierarchy of choosing a chemical to be included in the warning, which has the potential to increase the risk of consumer or product liability claims against manufacturers.
In addition to having to identify at least one chemical on the Prop 65 warning, the proposed rule requires a warning symbol to be included consisting of a black exclamation point in a yellow triangle with a bold black outline. The warning also would have to include a link to OEHHA's future Prop 65 website: www.P65Warnings.ca.gov/product.
The draft rule does allow for an exception to the chemical identification requirement if a manufacturer commits to providing the warning as an on-product warning label. For on-product labels, the name or names of a listed chemical are not required. The proposed safe harbor language also shortens the warning, which may make it easier to include on smaller products, e.g.: "WARNING: Cancer - www.P65Warnings.ca.gov/product." On the other hand, the warning symbol coupled with the "Cancer" declaration may be viewed as a harsher alternative to the more commonly-used warning language that a chemical is "known to the State of California to cause cancer." Critics have already commented that the proposed warnings will be ineffective and confusing to consumers.
Other key clarifications and revisions in the proposed draft:
- Makes it clear that the warnings can be provided on-line for internet purchases by including them on the product display page, a clearly marked hyperlink using the word "WARNING," or by "otherwise prominently displaying the warning to the purchaser prior to completing the purchase. The draft also clarifies that if the product has an on-product warning, the same content may be used on the internet, i.e., no identification of a specific chemical is required.
- Clarifies the responsibilities of manufacturers and retailers.
- Confirms common practice of using the cancer, reproductive toxicity or both warnings depending on classification of a chemical by OEHHA.
- Creates more defined warning requirements for environmental exposures.
- Expands the list of specific products, chemicals and area exposure warnings that have their own rules and exceptions, many memorializing Prop 65 settlements, e.g. prescription drugs, raw wood, dental care, furniture products, diesel engines and vehicles.
While OEHHA remains committed to revise Prop 65's warning requirements, it can be expected that many of the same critiques of the proposed changes that have been made in the past will be made again during this new round of public comments. In particular, commentators are likely to focus on the requirement that a specific chemical be named, the proposed pictogram and limitations on providing supplemental information relating to the chemical. Comments are due on April 11, 2016.