OEHHA Accepting Comments Until April 11th On Modifications To Proposed Prop 65 Warning Regulations
Efforts by the Office of Environmental Health Hazard Assessment (OEHHA) to amend Proposition 65 “clear and reasonable” warning provisions continue to unfold.
On March 25, 2016, OEHHA provided notice of modifications to its November 27, 2015 proposed regulations amending Proposition 65 safe harbor warning guidelines. The new changes to the proposed regulatory text were made in response to public comments received during the comment period that ended January 25, 2016. The November 2015 proposed regulations themselves had replaced previously proposed regulatory amendments, which OEHHA had withdrawn in response to public comments received earlier in 2015. OEHHA is accepting written comments on the new modifications until April 11, 2016.
The modifications attempt to clarify ambiguities in the proposed regulatory text and to address some of the uncertainty businesses might face in attempting to comply with the proposed Prop 65 warning guidelines. For example, as noted here, the November 2015 proposal provided that safe harbor warnings on labels must be in type no smaller than other “consumer information,” but in no case smaller than 8-point type, but failed to define whether the term “consumer information” included merely other types of product warnings, or possibly directions for product use, the product name, or anything else. With the March 2016 modifications, the proposed regulatory text now expressly defines the term “consumer information” and excludes from that term the brand name, product name, and product advertising, while expressly including warnings, directions for use, ingredient lists, and nutritional information. That modification gives business more clarity on which consumer product language is subject to the safe harbor guidelines. On the other hand, the modifications seem to create more ambiguity by removing the specific type size requirements, and instead requiring that the consumer product exposure warnings “be prominently displayed” and “with such conspicuousness as compared with other words . . . as to render the warning likely to be read and understood by an ordinary individual under customary conditions of purchase or use.” Despite this general language, OEHHA states that this new language was added to provide safe harbor guidance regarding consumer product exposure warnings and to clarify how such warnings must be provided.
Another important modification is a revised provision regarding what kind of supplemental information to a warning may be provided. In its original January 2015 draft regulatory amendments, OEHHA proposed that businesses could provide supplemental information to the warning, such as information about the form or nature of the exposure and ways to avoid it, as long as such supplemental information did not contradict, dilute, or diminish the warning. Business interests attacked such regulatory language as too vague, particularly the elasticity of the terms “dilute or diminish” (which they said would inevitably be used by private enforcers as a foothold to attack warnings in litigation), and as unconstitutionally restrictive of content-specific speech. In its November 2015 proposal, OEHHA removed the words “dilute or diminish” and simply prohibited supplemental information that contradicted the warning, thereby alleviating some of industry’s concerns. Now, in response to comments from NGOs advocating for the agency to bring back stronger language, the new proposed regulations allow supplemental information “only to the extent that it explains the source of the exposure or provides information on how to avoid or reduce exposure to the identified chemical or chemicals.”
The modifications also slightly alter product manufacturers’ and retailers’ responsibilities with regard to providing warnings. All along, OEHHA’s proposed amendments to safe harbor guidelines have been intended to provide more specific guidance regarding the responsibilities of manufacturers and retailers in providing warnings. This intent is consistent with Section 25249.11, which requires OEHHA to minimize the burden on retail sellers except where the retail seller itself is responsible for introducing a listed chemical into the product. The November 2015 proposed regulations therefore required the manufacturer, producer, packager, importer, or distributor of a product to affix a warning to the product or, alternatively, provide written notice to the retailer that a warning is required and to either include all necessary warning materials with the product or offer to provide such materials at no charge to the retail seller. As an initial note, the new changes add suppliers to the entities in the chain of commerce subject to these requirements. Furthermore, the modifications eliminate the option to offer to provide the materials to the retailer, while also now requiring the manufacturers, et al., to provide retailers with warning language for products sold on the Internet.
Other notable changes to the November 2015 proposed text include amendments to the particular language that a responsible party may use to satisfy safe harbor warning guidelines for consumer product exposures. Particularly, the November 2015 draft had proposed the following language: “This product can expose you to [name of one or more chemicals], a chemical [or chemicals] known to the State of California to cause” cancer or reproductive harm. The modifications now propose that a warning state that a product “can expose you to chemicals such as [name of one or more chemicals], which is [are] known to the State of California to cause” cancer or reproductive harm.
In cases where a product causes exposure to both listed carcinogens and reproductive toxicants, the modifications clarify that a warning must specify the presence of one or more chemicals for each of the two hazards. On the other hand, a warning may name a single chemical if that substance is listed as both a carcinogen and reproductive toxicant, provided that the warning makes clear that there is potential exposure to both endpoints by such chemical.
OEHHA will accept written comments on the amendments to the proposed regulation until April 11, 2016, at 5:00 p.m.
For further information and a detailed explanation of OEHHA’s modifications, please visit http://www.oehha.ca.gov/prop65/CRNR_notices/WarningWeb/Mod_Article6NPR032516.html.