On March 7, 2014, the Office of Environmental Health Hazard Assessment (“OEHHA”), the agency responsible for implementing California’s Proposition 65 (“Prop 65”), issued proposed changes to existing regulations that would make substantial changes to the Prop 65 warning requirements. These changes would require non-food products containing certain chemicals (such as lead or phthalates) to specifically name the chemical in the text of the warning, would require the inclusion of a pictogram for toxic hazards for certain warnings, and would allow certain small businesses (25 or fewer employees) to cure minor violations within a 14-day period. Although the changes provide additional guidance regarding Prop 65 warnings, they also impose additional burdens on companies that manufacture, distribute or sell consumer products with Prop 65 warnings.
A product sold in California that contains a chemical known to cause cancer or reproductive toxicity that has a “clear and reasonable” Proposition 65 warning is compliant with Prop 65 under the existing regulations. OEHHA’s existing regulations, adopted in 1988, provide general criteria for “clear and reasonable” warnings, which are referred to as “safe harbor” warnings. Over the years, many interested groups have asked OEHHA to amend the regulations to provide more guidance. Additionally, some environmental groups have expressed concern that the current safe harbor warning, which states that a product “contains” a chemical known to the State of California cause cancer or reproductive harm, is not sufficiently specific.
In 2013, Governor Jerry Brown proposed reforms to Proposition 65 by “ending frivolous ‘shake down’ lawsuits, improving how the public is warned about dangerous chemicals and strengthening the scientific basis for warning levels.” (See Press Release, Office of Governor Edmund G. Brown, Jr., May 7, 2013.) OEHHA held a public workshop in July 2013, at which concepts for possible amendments to the Proposition 65 warning requirements were discussed. OEHHA also accepted written public comments on its proposed changes to the current regulations.
Little has been done to end frivolous lawsuits or strengthen the scientific basis for the warning levels, although the state did pass AB 227, which allows small companies in very limited instances1 to cure alleged Proposition 65 violations within a 14-day period. By now issuing the proposed revised regulations, OEHHA has demonstrated its desire to make significant changes to the warning requirements in California, as well as make the opportunity to cure violations somewhat broader so that it applies to small businesses with less than 25 employees.
Summary of Key Proposed Changes
Although there are numerous proposed changes to the regulations, the most significant ones impacting manufacturers and retailers of consumer products are summarized below.
The “safe harbor” warning language would no longer be optional for companies but instead would be a mandatory requirement for Proposition 65 warnings. The proposed regulations state that the warning “must, at a minimum, comply with all applicable requirements.”
Where a product contains one of 12 chemicals (acrylamide, arsenic, benzene, cadmium, chlorinated tris, 1,4-dioxane, formaldehyde, lead, mercury, phthalates, tobacco smoke, or toluene) the warning must name the chemical, substance or mixture specifically in the warning. Accordingly, for a product containing lead and phthalates, the warning would need to specifically identify both chemical categories. The prior “safe harbor” version that simply stated that a product contains “chemicals” known to cause cancer or reproductive toxicity would not comply with the proposed revised regulations. This proposed change will perhaps have the most significant impact on companies since it could require companies to use numerous different Prop 65 warnings on various products and could make compliance with Prop 65 even more difficult than it already is for companies.
The definitions of several key terms are changed, including clarifying that food is considered a “consumer product”; combining the definitions of “Label” and “Labeling”; and expanding the definition of “Retail seller” to clarify how responsibilities of retailers differ from manufacturers of consumer products and foods (since manufacturers generally is in a better position to know what chemicals are in the product that may require a Prop 65 warning).
For consumer products, except where the retailer was selling a product under its own label, the proposed regulations would make consequence for failure to comply with the warning requirements the “primary responsibility of the manufacturer, producer, distributor, or packager of the consumer product….”
Very specific warning requirements for consumer products (other than food), including the manner of providing the warning, are proposed for the following warning methods: product labeling, internet purchases, catalog purchases, shelf-tag or shelf sign, and product-specific warning via electronic devices.
For certain consumer products, the international health hazard symbol would need to be including in the warning. Additionally, the warning would need to include the word: WARNING in all capital letters, bold print and 10 point type. Other language in the warning would need to be no smaller than 8 point type. The warning would need to also state: “For more information go to www.P65Warnings.ca.gov.” Finally, as noted above, the warning for consumer products (other than food) would need to specify the chemical or chemicals in the product if it contains one of the 12 chemicals identified in the regulations.
A retail seller with fewer than 25 employees will have a limited opportunity to cure a “minor violation” of the warning regulations (such as a short-term absence of a sign or inadvertent obstruction of a warning label or sign) if the retailer was previously in compliance and the violation is not due to intentional neglect or disregard of the regulations, not avoidable using customary quality control and maintenance, and is corrected within 24 hours of notification or within 14 days where software equipment must be repaired or replaced.
Companies that are already subject to requirements pursuant to a consent judgment (a court-approved settlement agreement) that is entered before January 1, 2015, will not be required to comply with the proposed changes to the regulations for the products and chemicals covered in the consent judgment.
Additional changes are proposed for warnings for prescription drugs and prescription medical devices, dental care, alcoholic beverages, restaurants, occupational exposure, and environmental exposure.
OEHHA has emphasized that the draft revised regulations is simply a “pre-regulatory proposal.” The lengthy documents that OEHHA has issued, however, demonstrates that OEHHA has already devoted considerable time and attention to making changes to the warning requirements. OEHHA will hold a pre-regulatory public workshop on April 15, 2014, and then proposal formal regulation in early summer 2014, with the anticipated date for adoption of the final regulation set for early summer 2015.
These proposed revisions will require all companies that have products sold, or otherwise do business, in the state of California, to thoroughly assess their Proposition 65 compliance efforts and potentially make major changes to their warning protocol. Companies should work with counsel and industry groups to assess these proposed changes and engage with OEHHA to the extent possible before the changes are adopted.
To review the complete pre-draft regulatory proposal issued by OEHHA, see http://oehha.ca.gov/prop65/warnings/030714warningworkshop.html
1 AB 227 applies only to businesses that sell alcoholic beverages, restaurants that sell foods and beverages that contain chemicals formed during preparation of the food and beverages on the premises, and certain businesses that cause exposures to environmental tobacco smoke and vehicle exhaust.