In a new draft of proposed revisions to the Proposition 65 warning regulations (Warning Regulation DISCUSSION DRAFT 092314), the California Office of Environmental Health Hazard Assessment has made certain improvements to its March 7, 2014 draft proposal. (See prior GLO report on OEHHA’s earlier proposal.) However, it’s unlikely that either the regulated community or Proposition 65 enforcers will be satisfied with all of the changes in OEHHA’s latest approach.
On the plus side, OEHHA’s latest draft proposal eliminates the previously proposed requirement to use the Globally Harmonized System (GHS) health hazard pictogram in Proposition 65 warnings. Instead, an exclamation point enclosed within a triangle would be required:
The warning text would require the phrase “This product can expose you…” rather than the more alarming “This product will expose you…” — another improvement. The current safe harbor phrasing for reproductive toxicant warnings, “birth defects or other reproductive harm,” would be replaced with the more streamlined “reproductive toxicity.” For better or worse, the draft also more clearly delineates warning responsibilities as between retailers and their upstream suppliers.
Significantly, OEHHA’s earlier requirement for businesses to submit detailed information about the warnings they provide (which OEHHA then would post on a website) has been revised and is now proposed to be located outside of the warning regulations — meaning that failure to provide such information would not be subject to enforcement as a failure to warn. The new draft also allows businesses to provide warnings other than those specified in the regulations, evidence of OEHHA’s intent to retain the current regulatory approach of giving businesses the opportunity to demonstrate that their warnings are “clear and reasonable” even if they do not fully comply with the safe harbor warning text and/or method of transmission.
However, overall the proposal will fall short of OEHHA’s stated goal to provide more meaningful warnings and reduce unnecessary litigation. Among the problems:
- Vague and inconsistent requirements and standards will cause confusion and be exploited by enforcers. For example —
- Although OEHHA apparently intends to allow businesses the opportunity to demonstrate that their warnings are clear and reasonable even if they do not fully comply with the regulations, OEHHA’s regulatory language on this point is vague and circular.
- The warning text for many warnings explicitly allow the business to use the plural “chemicals” in the warning; the warning text for others (e.g., food) does not.
- Phrases like “actual knowledge” (this phrase used in reference to the trigger for a retailer to provide warnings in certain circumstances) will invite litigation about what, exactly, constitutes such knowledge.
- While the proposal would “grandfather” in the warning requirements established by pre-2015 court-approved settlements, it still would not account for the hundreds, perhaps thousands, of out-of-court settlements. Non-parties to pre-2015 court-approved settlements would have to invest the time and expense to petition OEHHA to adopt those court-approved warning requirements into the regulations.
- The proposal retains the previously proposed requirement to identify the specific chemical being warned for, if the chemical is on the list of 12 (acrylamide, arsenic, benzene, cadmium, chlorinated tris, 1,4-dioxane, formaldehyde, lead, mercury, phthalates, tobacco smoke and toluene).
- The proposal appears to require warnings for prescription drugs to explicitly reference the Prop 65 cancer or reproductive toxicity health endpoints, a requirement that will trigger preemption arguments and would inappropriately invade the health care provider-patient relationship.
- The proposal improves the prior version’s treatment of occupational exposure warnings, but likely still will trigger federal preemption arguments — and litigation over it.
This draft is not a formal rulemaking but a discussion draft only. Although OEHHA is receiving comments on this latest proposal, it has not published a deadline for comments and it is not clear whether OEHHA will schedule a public workshop. It is likely that OEHHA will publish a formal rulemaking later this year. It would behoove interested parties to make their voice heard now and submit comments to this latest proposal.