On March 7, 2014, the California Office of Environmental Health Hazard Assessment (OEHHA) released a proposal for a draft regulation amending Proposition 65 regulations. The proposal seeks changes to the warning requirements to include more detailed information, including the names of the chemicals covered by individual warnings, the ways that individuals are exposed to these chemicals, and how individuals can avoid or reduce their exposure to these chemicals. This column explains this proposal and its significance.
The proposal "is to improve the quality of Proposition 65 warnings while providing both flexibility and certainty for businesses." The following are the minimum required core elements for warnings that this proposal would establish:
Pictogram: Proposed Section 25607.2(a)(1) would require the inclusion of the following standard (Globally Harmonized System) pictogram:
This pictogram would have to appear on all Proposition 65 consumer product warnings, with limited exceptions for food products, drugs and medical devices; occupational warnings; and environmental warnings.
Warning Signal Word: Proposed Section 25607.2(a)(2) would require that the signal word "WARNING" appear in all capital letters and bold print.
"Expose": The current warning is: "WARNING: This area contains a chemical known to the State of California to cause [cancer or birth defects or other reproductive harm]." Proposed changes would modify this to "WARNING: This product will expose you to a chemical [or chemicals] known to the State of California to cause [cancer or birth defects or other reproductive harm]."
Chemical Name Disclosure: Proposed Section 25605 would require disclosure of the following 12 chemicals in the text of the warning: acrylamide; arsenic; benzene; cadmium; chlorinated tris; 1,4-dioxane; formaldehyde; lead; mercury; phthalates; tobacco smoke; and toluene.
New Website: Proposed Section 25604 would require on the label a link to a new OEHHA-hosted website (www.P65Warnings.ca.gov) to allow the public to access more information relating to the warning, including additional chemicals, routes of exposure, and if applicable, any actions that individuals could take to reduce or avoid the exposure.
Opportunity to Cure: To avoid frivolous litigation, proposed Section 25607 includes a new "Opportunity to Cure" provision that would provide small retailers (establishments with 25 or fewer employees) an opportunity to address certain minor warning violations (e.g., a short-term absence of a sign or inadvertent obstruction of a warning label or sign) if the retailer was previously in compliance; the violation is not due to intentional neglect or disregard of the regulations, not avoidable using customary quality control or maintenance; and the violation is corrected within 24 hours of discovery or notification, or within 14 days where software equipment must be repaired or replaced.
The proposed changes provide additional guidance regarding Proposition 65 warnings (e.g., recognizing warnings covered by existing court-approved settlements) that may help some in industry and expand provisions to prevent frivolous lawsuits. However, the proposal also includes game-changing additional warning requirements that are sure to inspire controversy for companies that manufacture, distribute or sell consumer products with Proposition 65 warnings.
OEHHA states its proposal is intended to provide more meaningful information for individuals in Proposition 65 warnings, facilitate the public's understanding and make the warnings more consistent. However, it's possible these changes could have the opposite effect. Because the proposed changes would significantly increase the mandatory elements of a warning, create different warning requirements for a multitude of specific circumstances and require companies to compile and report burdensome exposure information, the regulations could create more compliance and consistency issues while also causing confusion for the general public.
OEHHA is encouraging parties to submit written comments via e-mail, rather than in paper form, by May 14, 2014. OEHHA has stated its intent to propose formal regulations in early summer 2014 and adopt final regulations in early summer 2015. There also are plans to develop a website concurrent with the regulatory process.
Companies should review carefully the proposal and how the significant changes to the warning requirements will affect their cost and compliance capabilities. The draft regulation and Initial Statement of Reasons are available for public review on OEHHA's website at http://oehha.ca.gov/prop65/warnings/030714warningworkshop.html.
LYNN BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at email@example.com
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006).