OEHHA Releases Guidance Regarding Proposition 65 Regulations for Clear and Reasonable Warnings
By Lynn L. Bergeson
For readers not following Proposition 65 (Prop 65) changes, you need to read this column. Big changes are in store for regulated entities subject to Prop 65 based on a rule implemented in August 2016, but with a fast-approaching enforcement date of Aug. 30, 2018.
Prop 65 requires businesses to notify Californians about significant amounts of listed carcinogens and reproductive chemicals in the products they purchase, use in their homes or workplaces, or that are released into the environment. What is considered a “clear and reasonable warning” under Prop 65 has been the subject of debate for years. Most recently, the form and content of warnings under Prop 65 have been the subject of rulemakings by the California Office of Environmental Health Hazard Assessment (OEHHA). In August 2016, OEHHA modified the Prop 65 warning regulations when it adopted the November 27, 2015, proposed rule and the March 25, 2016, revisions that changed the Prop 65 clear and reasonable warning requirements. The new rules change significantly the content of warnings under Prop 65, and regulated entities should be considering now how best to comply with these new requirements.
Most recently, OEHHA released a Questions and Answers for Businesses (Q&A) document related to its Aug. 28, 2016, adopted revisions to the Prop 65 regulations covering “clear and reasonable warnings” requirements. The Q&A document provides important guidance on issues related to those responsible for providing warnings, the methods for providing warnings via the Internet or catalogs, short-form (previously on-product) warnings, and issues related to occupational and environmental exposure warnings. As noted, the warnings become operative on Aug. 30, 2018, at which time the existing warning methods and content will no longer be operative.
OEHHA also clarifies in the guidance that the date the product is available for purchase does not determine whether the product should have a new warning. Instead, a consumer product that is manufactured prior to Aug. 30, 2018, and labeled with a warning that is compliant with the September 2008 version of the regulations is deemed to be compliant with the new regulations.
There are potentially complicated supply chain issues that can arise regarding who is responsible for providing a warning. Under the new rules, if a company is a manufacturer or producer of a consumer product, but does not sell it directly to retailers, it has two options for compliance: label the product with the required warning; or provide a warning notice and the warning materials to the packager, importer, supplier or distributor via their authorized agent. Manufacturers and others in the chain of commerce should take appropriate actions to ensure that the warning is passed along to the retailer and ultimately to the consumer; OEEHA recognizes that how that is done will vary from situation to situation. A manufacturer or producer may choose to enter into a contract with other businesses along the chain of commerce for their product to ensure that the warning is appropriately transmitted to the retailer and end consumer.
OEHHA provides helpful guidance related to several aspects of the new requirements related to the actual warning language. OEHHA states that the yellow equilateral triangle with a bold black exclamation mark symbol can be provided in just black (no yellow) if a business does not use the color yellow for other information provided on the label or sign.
Regarding the requirement to identify the name of one or more of the listed chemicals for which the warning is being provided, OEHHA provides this example:
If there are five possible chemical exposures from a given product, and all five chemicals are listed only as carcinogens, then the business would only be required to name one of those five chemicals in the warning. However, the business may identify any or all of the remaining four chemicals if it chooses to do so. If there are exposures to both carcinogens and reproductive toxicants, a business would be required to name one of the chemicals that is a carcinogen and one of the chemicals that is a reproductive toxicant, but the business could choose to identify more chemicals in the warning. If the warning covers exposure to a chemical that is listed as both a carcinogen and a reproductive toxicant, the warning would only need to name that one chemical, however both endpoints would need to be included in the warning. The business could choose to identify more chemicals covered by the warning.
There have been questions about whether warnings must be provided for catalog purchases. Under the safe harbor provisions of the regulations, warnings are required to be provided for purchases made through catalogs prior to completing the purchase and a warning must be provided via any one of the four methods available for consumer products. In addition, if an on-product (short-form) warning is provided on the product label, the catalog warning may use the same content. OEHHA also confirms that it would not meet the requirements for a business to place the warning symbol next to the product and use it as a reference to a full consumer product warning provided elsewhere in the catalog or website, as this approach is “unlikely to ensure that the warning is ‘clearly associated’ with the item being purchased.”
Many other issues are addressed in the Q&A document and stakeholders are urged to review the guidance carefully and well in advance of the August 2018 deadline.
What is at Stake?
The enforcement of Prop 65 has been the bane of industry’s existence for decades. That is not to say the warnings do not fulfill an important right to know goal, as they do. The enforcement scheme has been challenging and controversial, however. Under the law, “any person” may file a lawsuit alleging non-compliance if, after issuing a 60-day notice letter, the California Attorney General or any of the County District Attorneys decline to take action. Civil penalties are steep and calculated on a per-chemical, per-day basis. The law is believed to incentivize citizen lawsuits in that citizens are awarded one-fourth of the civil penalty — hence the “bounty” hunter characterization of Prop 65. The standard of proof is also very lax as there is no requirement to prove injury and plaintiffs’ attorney fees are routinely awarded. Often, rather than fight, companies end up settling claims to avoid the cost of litigation.
In light of the significant changes in the law and the need for new and different warnings under Prop 65, there is every reason to believe citizen and state enforcers will be on the prowl come August. These are not trivial changes and care will need to be taken to understand the rule and come into compliance with it. Start now and avoid the August rush.
Lynn L. Bergeson is Managing Partner of Bergeson & Campbell, P.C. (B&C®), a Washington, D.C. law firm focusing on conventional, nanoscale, and biobased industrial, agricultural, and specialty chemical product regulation and approval matters, environmental health and safety law, chemical product litigation, and associated business counseling and litigation issues. Lynn is President of The Acta Group (Acta®), with offices in Washington, D.C., Manchester, UK, and Beijing, China, and President of B&C® Consortia Management, L.L.C. (BCCM) with offices in Washington, D.C.