California's Proposition 65: History and Proposed Amendments in 2016
In 1986, California voters passed the Safe Drinking Water and Toxic Enforcement Act, otherwise known by its original name, Proposition 65. Proposition 65 requires the California Office of Environmental Health Hazard Assessment (OEHHA) to publish a list of chemicals known to cause cancer, birth defects or other reproductive harm. OEHHA’s current list includes over 800 chemicals. Proposition 65 further requires businesses to provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone in California to a listed chemical.
A great deal of controversy and confusion has developed over the years as to what constitutes a “clear and reasonable” warning under Proposition 65. Although Proposition 65 contains a safe harbor provision wherein a business may protect itself by placing warnings specified in the regulations on its products, the regulations dealing with the safe harbor provision are often difficult to understand and apply to specific situations.
Enforcement of Proposition 65
As an enforcement mechanism, Proposition 65 contains a “bounty hunter” provision whereby private parties, without alleging any exposure to a listed chemical, may sue businesses to enforce Proposition 65’s warning provisions. If successful, the plaintiff may recover 25% of any civil penalties imposed on the company, along with attorneys’ fees and costs. Due to these enforcement provisions, a plethora of enforcement lawsuits have been brought by various citizen groups against product manufacturers, suppliers, and/or retailers alleging non-compliance with Proposition 65 since its enactment in 1986.
Timeline of Proposition 65 Amendments
Three years ago, California’s Governor Jerry Brown announced his proposal to reform Proposition 65 in response to years of suspect enforcement lawsuits. In response, OEHHA issued a notice to repeal and replace the requirements under Proposition 65 for a “clear and reasonable” warning.1 However, OEHHA’s January 2015 proposal arguably made compliance for businesses even more burdensome. For instance, the January 2015 proposal considerably changed the warnings requirements specified in Proposition 65, including the establishment of a proposed requirement that warning labels identify each specific chemical in any product sold in California, among a list of 12 chemicals (the “dirty dozen”), identified by OEHHA as commonly found in consumer products. Chemicals listed among the “dirty dozen” included lead and phthalates.
On November 27, 2015, due in part to the considerable opposition to the proposal, the OEHHA formally withdrew its January 2015 proposal and released new draft amendments to Proposition 65. Significantly, the November 2015 proposal for Proposition 65 eliminated the “dirty dozen” provision and made several other clarifications. After issuing the November 2015 proposal, the OEHHA requested further public comments and conducted a public hearing in January 2016. In response to its request, the OEHHA received 45 written comments from the public.
On March 25, 2016, the OEHHA issued a modification of its November 2015 proposal in response to the written public comments and issues raised at the public hearing in January.
The most recent proposal for modifying Proposition 65’s safe harbor warning label requirements (including the March 2016 modification) states that consumer product warnings labels must do the following:2
- Identify the listed chemicals published by the OEHHA (not just the “dirty dozen”) for which the warning is being provided;
- State that the product “can expose” the individual to a listed chemical, rather than that the product “contains” the listed chemical as previously proposed;
- Contain the word “WARNING,” in all capital letters with a black exclamation mark within a yellow equilateral triangle;
- Contain a hyperlink to a yet-to-be created Proposition 65 website to be established by the OEHHA;
- Include non-English languages where the product labeling contains information in alternative languages.
Also under the current proposed amendments, businesses are allowed to make agreements with retailers to allocate legal responsibility for the required warnings. The new proposal also makes the following changes to the current Proposition 65 requirements:
- Alteration of the regulations regarding font size of the labels for the methods of transmitting consumer product exposure warnings;
- Clarification of the methods of transmission for consumer product exposure warnings for internet sales;
- Clarification of the placement of responsibility for providing warnings on manufacturers, distributors and producers;
- Addition of a requirement for a manufacturer, producer, packager, importer or distributor of a product to notify the retail seller of an additional notice within 90 days if a new chemical name or hazard (cancer and/or reproductive toxicity) is required to be included in the warning on a product.
The new proposed amendments also clarify that warnings used by parties subject to a court-approved consent judgment, entered before the effective date of the proposed regulations, are considered “clear and reasonable.”
If adopted, the proposed regulations will not take effect until 2018. Any warnings for a product manufactured prior to the adoption of the new proposals are grandfathered into the new proposal, as long as the product's warnings comply with the September 2008 warning regulations under Proposition 65.
The OEHHA accepted written comments on its March modifications to Proposition 65 until April 18, 2016. To date, no public hearing has been scheduled on the modifications. However, the proposals to amend Proposition 65’s safe harbor warning label requirements will not become law until finally adopted by OEHHA. Under the California Administrative Procedure Act, the OEHHA has until November 2016 to adopt a final rule modifying Proposition 65. As stated above, under the current version of the proposal, no regulation will take effect until 2018.
It is anticipated, although not certain, that the OEHHA will make further proposed changes to Proposition 65 before a final rule is issued, based on the most recent comments received following the March modification. Given the confusion surrounding Proposition 65 and the significant risk of liability, it is prudent for any consumer products manufacturer, distributor and/or retailer distributing products in California to closely follow the amendment process.
For more information about Proposition 65 and its proposed amendments, please contact Benjamin Woodard or the Stinson Leonard Street attorney with whom you regularly work. For additional literature and insights from the Stinson Leonard Street Children’s Products Group, please visit our webpage and subscribe to receive future content.
1The OEHHA began the process of repealing and replacing the warnings provisions in 2014; however, the most significant prosed amendments occurred in January 2015.
2There are exceptions for some of these requirements for on-product warnings under the proposal's changes to Section 25603, which set out requirements for a specific product, chemical and area exposure warnings.