In March 2014, OEHHA began the rulemaking process to amend the Clear and Reasonable Warning requirements for California’s Proposition 65. The proposed changes caused a great deal of concern for manufacturers, distributors, and retailers doing business in California. On September 23, 2014, OEHHA circulated a revised draft to some of the stakeholders. While the proposed changes appear to be an improvement on the March edition, there still are some significant concerns in the business community. Here are highlights of the September draft.
Safe harbor warnings
The current Prop 65 warning regulation, in effect since 1989, provides a generic description of a “clear and reasonable” warning, and a series of “safe harbor” warning methods and messages that are deemed to be in compliance with the law.
OEHHA’s March 2014 proposal would have removed the safe harbor approach, and mandated that all warnings be given as specified. Following significant opposition, the September 2014 draft regulation returns to the safe harbor approach, by providing specific warning methods and messages, but allowing businesses to use other warnings.
However, the proposal does not provide criteria for determining whether a non-safe harbor warning will comply with Prop 65 requirements, although it grandfathers court-approved warnings prior to January 1, 2015.
OEHHA’s March proposal would have required manufacturers to provide detailed information regarding the chemicals in products for which warnings are given, as well as routes and magnitude of exposure.
The September draft regulation drops this requirement, and provides that OEHHA will host a website to collect and provide information to the public concerning exposures to listed chemicals, including links to administrative entities that may provide information on the subject, listing of information concerning levels of human exposure and other more specific information for exposures from food products.
The provision also lists categories of information that OEHHA can require manufacturers and distributors to provide, although failure to comply with information requests will not be deemed a violation of Prop 65.
The September draft regulation establishes specific requirements for internet warnings, stating: “For internet purchases, the warning message must be provided on the internet by a clearly-marked hyperlink on the product display page, or otherwise prominently displayed to the consumer before the consumer completes his or her purchase of the product.” Most importantly, consumers must be able to see the warning before they complete their purchase.
The September 23 draft regulations further flesh out OEHHA’s attempt to allocate responsibility for Prop 65 warnings between manufacturers, distributors, importers and retailers.
Except for private label products, the regulation squarely places responsibility for providing warnings on the manufacturer or products in the first instance, and on the distributor, importer or packager in the second instance (and only if the manufacturer or producer is not exempt from Prop 65 or is a foreign entity with no agent for service of process).
A retailer is only required to provide a warning for a non-private label product if the manufacturer, distributor, importer, or packager are all (a) exempt from Prop 65, and/or (b) foreign entities with no agent for service of process.
A manufacturer’s warning obligation can be discharged by providing notice to a retailer that the product requires a warning, along with all required warning materials, although the retailer must provide “written acknowledgement of receipt” in order for the manufacturer to rely upon this method of providing warnings.
“Knowingly” and opportunity to cure
OEHHA creates a broader opportunity for retailers to cure alleged violations by revising the definition of “knowingly.”
One provision states that a retailer who does not receive a notice of violation from an enforcer or a notice from a supplier that a product requires a warning “and who otherwise does not have actual knowledge of that exposure, has not caused a knowing and intentional exposure by selling the product.”
A second provision provides that a retailer is deemed to have knowledge of a potential exposure that occurs more than 48 hours after its authorized agent for service of process receives a 60-day notice, at which time the retailer is responsible for providing warnings.
In theory, this means that a retailer could cure alleged violations within 48 hours of receiving a 60-day notice. Retailers are expected to seek a longer time to respond, as 48 hours may be an impracticably short time to either pull products from sale or label them with warnings in every California store.
However, if a retailer could cure the violations in the specified time frame, it would be extremely difficult for most enforcement cases to be brought because plaintiffs would have to show actual knowledge of exposure prior to receipt of the 60-day notice.
For consumer products, the safe harbor warning language has been changed slightly to read: “This product can expose you to a chemical [or chemicals] known to the State of California to cause cancer [and/or reproductive toxicity]. For more information go to www.P65Warnings.ca.gov.”
All warnings must include a triangle with exclamation point.
For product labeling, unless otherwise forbidden by federal law, the warnings must be provided in the box, be in specific font sizes, and include truncated warning messages.
All warnings must be legible and conspicuously printed and must be provided in a manner likely to be seen by the consumer.
The agency is also proposing that 12 ubiquitous chemicals (including lead and phthalates) be identified in the warning if the safe harbor is used.
OEHHA has also proposed specific warning methods and messages for wood products, furniture products, diesel engines, foods, alcoholic beverages, restaurants, Rx drugs and dental care.