Part 1
On September 2, 2016, The Office of Environmental Health Hazard Assessment (“OEHHA”), the lead agency for California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (normally referred to as “Proposition 65”) substantially revised its “Safe Harbor Warning” regulations. 
As a reminder, the statute itself, at Health and Safety Code section 25249.6 requires that “No person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual . . . “ The statute does not define what a “clear and reasonable warning is.” In 2008, OEHHA issued safe harbor warning regulations which, while not requiring that their language be used in lieu of any other, provided that if the safe harbor language was used, it would be deemed clear and reasonable. This resulted in ubiquitous use of signage and labels containing language such as “WARNING: This product contains a chemical known to the State of California to cause cancer.”
As CBL reported in no fewer than six blog posts in the Fall of 2016 (you can find the first one here, and five more immediately after), the changes were enormous, made life much more difficult for businesses, and contained many ambiguities.
The changes do not become mandatory until August 30, 2018. But late last year, OEHHA amended the changes (with the amendments also taking effect August 30). Companies seeking to comply with Proposition 65 – which, from a business perspective, should be every company doing business in California or who has a product sold in California – should be aware of the amendments, and incorporate them into their compliance strategy.
A redlined document demonstrating all of the changes is available on the OEHHA web site here. And CBL’s analysis of the most significant changes (including some redlined quotes) will be here and in three blog posts after this one. Today, we’ll look at three major changes to definitions.
DEFINITIONS:
Some of the definition changes to section 25600.1 of the regulations really make a difference. Here are the ones CBL sees as the most important:
(b) “Authorized agent” means the person or entity, including a monitored electronic mailbox or post office box, designated by a retail seller to receive notices from product manufacturers, producers, packagers, importers, suppliers, and distributors under this article.
Why does this matter? Section 25600.2 of the new regulations allows a manufacturer, producer, packager, importer, supplier or distributor to shift warning responsibility to retailers by providing specified information and warning labels to the “authorized agent” of the retailer on a semi-annual basis for the first year of the new regulations and an annual basis after that. The original regulations defined “authorized agent” as the person “designated by a retail seller to receive notices,” and it’s a safe bet that many retailers have no such person.
The revised definition seeks to fix this limitation by including a “monitored electronic mailbox or post office box.” The addition of “post office box” is puzzling, as many retailers will receive their postal mail at their brick and mortar facilities, not at post office boxes. So it is CBL’s belief that to utilize the burden shifting provisions of section 25600.2 of the regulations, the safest method is to obtain confirmation that a specific individual is the “authorized agent” for receiving notices (e.g., an e-mail to him or her or the person’s supervisor: “Is X authorized to receive safety notices from us?, and is X’s mailing address _______?”) followed by postal service certified mail with a return receipt request.
(i) “Label” means a display of written, printed or graphic material that is printed on or affixed to a product or its immediate container or wrapper.
This is pretty simple, providing clarification that the warning can be on a separately added label or printed directly on the product or its packaging or wrapper.
(j) “Labeling” means any written, printed, graphic, or electronically provided communication that accompanies a product such as a package insert including tags at the point of sale or display of a product.
As with the previous regulations, the new ones define “labeling.” The 2008 safe harbor regulations provided that safe harbor warnings could be placed on “labeling,” and at least one court decision could be reasonably interpreted to provide that “labeling” included manuals and use and care guides. OEHHA did not like this, and included a definition of “labeling,” in the new regulations, but no provisions for including warnings in the “labeling” no matter how the word was defined. Now, the agency has not only slightly changed the definition of “labeling,” but acknowledged that warnings can go on “labeling,” although such warnings apparently will still not meet the “safe harbor warning” requirements. There will be more about this in CBL’s next post when we discuss changes to section 25600.2.