On August 30, 2018, new “Clear and Reasonable Warning” regulations take effect in California.  The ubiquitous signs and labels advising of the presence of chemicals that cause cancer or reproductive toxicity will all need to be changed to incorporate new “safe harbor” language or those providing the warnings will be at risk of enforcement.  For some, it will be a straightforward matter of revising the language, for others, it will be a more nuanced exercise of examining potential chemicals and evaluating warning obligations.  In most cases, the generic signs with which we are familiar will no longer do. 

Proposition 65 (Prop 65)  requires a warning before exposing a person in California to any of the 900-plus chemicals listed as causing cancer or reproductive toxicity.  Failure to do so subjects manufacturers, distributors, and even retailers, as well as certain property owners, to enforcement for violation of Prop 65. 

The warnings must be “clear and reasonable,” a vague standard at best.  The new regulations establish specific warning content and methods for transmitting the warning that will be deemed “clear and reasonable” under the statute.  The specified content and warning methods are not required, but alternative approaches are vulnerable to challenges claiming they do not meet the clear and reasonable standard.  To be afforded “safe harbor” from alleged violation and enforcement, warnings must incorporate the specified content and warning methods.

Warning Content

The language specified by the current regulations for most consumer products consists of a notice of the presence of chemicals known by the state of California to cause cancer, birth defects or other reproductive harm.  In an effort to provide more meaningful information about the chemicals present in consumer products and various public spaces, the new regulations require the name of at least one of the chemicals triggering the warning.  If, among the triggering chemicals, some have an endpoint for cancer and others have an endpoint of reproductive toxicity, then at least one chemical must be identified for each endpoint.  In addition, a new warning symbol must be included: a yellow triangle with a black outline containing an exclamation point.  Finally, the warning must include a reference to the new Prop 65 government webpage that contains a searchable chemical database and related information for consumers.  The basic warning for a consumer product containing a carcinogen and a reproductive toxin now reads:

 

Warning TriangleWARNING: This widget can expose you to chemicals including acetaldehide, which is known to the State of California to cause cancer, and mercury which is known to the State of California to cause reproductive toxicity or other reproductive harm.  For more information, go to www.P65Warnings.ca.gov

 

The new regulations limit other “supplemental” information provided with the warning to only the source of exposure or information on how to avoid or reduce exposure.  A warning that includes other information loses automatic safe harbor protection.

Warning Methods 

Several safe-harbor methods of communicating the warning are described in the regulations, including on-product labels, product specific shelf signs where products are displayed, and product specific warnings provided by electronic devices or processes (such as QR codes).  For internet sales, product-specific warnings or hyperlinks to warnings must be provided prior to purchase, even if the product is labeled with a warning.  Similarly, warnings must be provided in catalogs in a manner that clearly associates the warning with specific products.  To be subject to safe harbor protections, the warnings must follow specific details specified with each method.

In an effort to minimize the burden on retailers, the regulations provide for a detailed process by which manufacturers, importers, packagers, distributors and other suppliers can transfer responsibility to retailers by providing and renewing written notification to a retail seller’s authorized agent.  However, retailers are directly responsible for their own brands and in certain other situations.

Tailored Warnings 

Tailored warnings for specific chemical exposures, products, and areas have been updated and substantially expanded to include dental care, wood dust, furniture, diesel, vehicles, recreational vessels, enclosed parking facilities, amusement parks, petroleum products, designated smoking areas, service stations, restaurants, and hotels, in addition to alcohol and food.  To be deemed “clear and reasonable,” tailored warning for any of the specific situations must incorporate the particular content and warning method specified in the regulations.  For example, food warnings provided on packaging need not display the triangle symbol, but must appear within a box.  The content of restaurant warnings must include specific language about acrylamide in “many fried and baked foods” and mercury in fish.  Environmental exposure warnings must include a map. 

Compliance Challenges

The need to identify Prop 65 chemicals to which exposure may occur may be a challenge for some.  The generic language of the old warning allowed one to achieve compliance on the basis of one listed chemical.  If that chemical has only a cancer endpoint, for example, what is the obligation of the producer to investigate the potential presence of reproductive toxins?  If they are present, the warning will not be in compliance unless one is identified.  And now that chemicals must be named, those who provided a warning without knowing whether listed chemicals are present are now faced with evaluating their products to determine which to identify.

Those providing environmental warnings must also identify the source of the chemicals identified.  And in some cases, the greater challenge may be determining applicability of tailored warnings.  For example, is a ceiling all that is needed to constitute an ”enclosed parking garage?”  Are walls necessary?  

Some will have little reason for frustration with the new regulations:  those providing warnings in compliance with the warning content and methods established in court ordered settlements or final judgments to which they are a party are deemed to be providing clear and reasonable warnings.  This means, however, that old-style warnings will continue in use for many products.