Cal Biz Lit

CHANGING THE CHANGES: OEHHA REVISES ITS REVISIONS TO THE NEW PROPOSITION 65 “SAFE HARBOR WARNING” REGULATIONS -- PART 3

One element of the 2016 revisions that was of interest to many companies was the “short form warnings.” These allow companies to shorten their warnings on both products and catalogs and web sites to just a few words: “WARNING: Cancer,” or “WARNING: Reproductive Harm,” or “WARNING: Cancer and Reproductive Harm,” followed by the url www.P65Warnings.ca.gov. But the regulations raised some uncertainties, and OEHHA has tried to address at least some of these.

SHORT FORM WARNINGS

The “short form warning” regulations have received many changes, but most of them are not very significant.  There is one, however, that resolves a potential major disagreement about the new regulations.  Here is the newly revised subpart (a) (4) of section 25602:

• Unless otherwise specified in Section 25607.1 et seq, a warning meets the requirements of this subarticle if it complies with the content requirements in Section 25603 and is provided using one or more of the following methods:

(4) An on-product short-form warning on the label that complies with the content requirements in Section 25603(b). The entire warning must be in a type size no smaller than the largest type size used for other consumer information on the product. In no case shall the warning appear in a type size smaller than 6-point type.

This is important.  Before the change, the regulations specifically stated that the “short form warning” (e.g., “WARNING: Cancer - www.P65Warnings.ca.gov”) had to be on the product. OEHHA had told inquirers that it could be on the label, but that wasn’t what the previous version of the regulation said. Now, OEHHA has changed the regulation to conform to the advice it was giving, and the short form warning, like the long form warning, can be on the product, on a label, or on the packaging.

In Cal Biz Lit’s next post, we’ll talk about the changes in safe harbor warnings for furniture and motor vehicles.

CHANGING THE CHANGES: OEHHA REVISES ITS REVISIONS TO THE NEW PROPOSITION 65 “SAFE HARBOR WARNING” REGULATIONS - PART 2

In Cal Biz Lit’s last post, we talked about how OEHHA had revised the safe harbor warning regulations in September, 2016 (with an effective date two years later) and had just recently revised the revisions. We focused on the changes in some of the definitions and what those changes might mean. Now, our review and analysis of the regulation changes continues.

RESPONSIBILITY FOR PROVIDING WARNINGS:

The key here is section 25600.2, mentioned in CBL’s last post.  There are two major elements to this provision.  One is a general statement about how manufacturers, producers, packagers, importers, suppliers or distributors meet the Proposition 65 requirements by providing the warning themselves, and the other how they may comply by shifting the requirement to retailers.

(b) The manufacturer, producer, packager, importer, supplier, or distributor of a product may comply with this article either by providing a warning on the product label or labeling affixing a label to the product bearing a warning that satisfies Section 25249.6 of the Act, or by providing a written notice directly to the authorized agent for a retail seller.

As with all California regulations, these are accompanied by an “Initial Statement of Reasons,” supposedly explaining why OEHHA is doing what it is doing, and the statement as to this revision is perplexing at best: “The term “labeling” was added because a business is not required to use the safe harbor warning methods in Subarticle 2 in order to comply with Section 25600.2.”  This seems to ignore the introductory provision in section 25600(a):

. . . Subarticles 1 and 2 apply when a clear and reasonable warning is required under [Proposition 65]. Subarticle 1 sets forth general provisions applicable throughout this article, including the allocation of responsibility among parties when a warning for a consumer product is required under the Act. Subarticle 2 provides “safe harbor” content and methods for providing a warning that have been determined “clear and reasonable” by [OEHHA].

So OEHHA has created yet another ambiguity in its regulations. On the one hand, there is at least a suggestion of warnings on “labeling” – defined as any document that accompanies the product – while on the other hand, the “safe harbor warning” transmission methods in the regulations include no provision for placing warnings on “labeling.”

Provisions in this section also relate to shifting the burden to a retailer, emphasizing the transmittal to an “authorized agent,” as discussed in the definitions above. But more specifically, they change the provisions for renewal of notices to retailers:

(c) If the manufacturer, producer, packager, importer, supplier, or distributor of a product is complying with this section by providing a written notice directly to the authorized agent for the retail seller:

(1) The notice must be renewed, and receipt of the renewed notice confirmed electronically or in writing by the retail seller’s authorized agent within six months during the first year after the effective date of this section by no later than February 28, 2019, then annually thereafter during the period in which the product is sold in California by the retail seller.  

In other words, no matter when the manufacturer or other upstream source first transfers responsibility to retailers, it must renew its notice, and the renewal’s receipt must be confirmed no later than February 19, 2019.  

Cal Biz Lit has t wo more posts coming on the recent revisions.  The next one will address the “short form warning” changes.

CHANGING THE CHANGES: OEHHA REVISES ITS REVISIONS TO THE NEW PROPOSITION 65 “SAFE HARBOR WARNING” REGULATIONS

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.