California Approves New Amendments to Proposition 65 Safe-Harbor Regulations
The California Office of Environmental Health Hazard Assessment (OEHHA) announced on December 6, 2017, that the state had approved new amendments (Final Amendments) to the Proposition 65 Clear and Reasonable Warning regulations (safe-harbor regulations) introduced in July 2017. The Final Amendments largely track the July proposal, with only a few further adjustments highlighted below. The Final Amendments become fully operative on August 30, 2018.
In 2016, OEHHA comprehensively redesigned the California Proposition 65 safe-harbor regulations under Title 27, Article 6 of the California Code of Regulations. Warnings that conform to the safe-harbor methods and content in the regulations are deemed “clear and reasonable” under the Proposition 65 statute.
Since the promulgation of the 2016 amendments, OEHHA has made further efforts to clarify the new safe-harbor regulations. As we previously reported, one such effort was the July 2017 proposal with numerous minor modifications intended largely to clarify the provisions and ensure consistent use of terminology. See the Notice of Proposed Rulemaking Summary and Initial Statement of Reasons for details.
After receiving and reviewing six comments, OEHHA determined that “no substantive modifications to the proposed amendments were necessary.” Five proposed amendments were withdrawn, all for reasons relating to the phrasing of the regulation. Among the Final Amendments, several points are worth highlighting.
The definition of the term “authorized agent,” for purposes of communicating warning notices and materials to retail sellers, now includes “a monitored electronic mailbox or post office box.”
The definition of “label” includes warnings that are “printed on” a product or its immediate container or wrapper. This change is intended to clarify that there is no requirement to affix a separate warning label to the product if the warning is printed on the product or its immediate container or wrapper.
Consistent with the changes to the definition of “label,” the term “on-product” is replaced with the term “short form” throughout Article 6 to clarify that the short-form warning can be affixed to or printed on a product or its immediate container or wrapper.
The definition of “labeling” deletes the reference to “tags at the point of sale or display of a product” and includes a new reference to a “package insert” as an example of labeling. According to OEHHA, shelf tags are a form of signage, not labeling.
Notably, OEHHA declined to incorporate a reference to package inserts in the definition of a label, noting that the definitions of “label” and “labeling” are distinct and that warnings provided in package inserts such as user manuals are generally not sanctioned as a stand-alone warning method for consumer product exposures. However, forms of labeling – including the use of package inserts – are included as an adjunct warning method in several of the tailored safe-harbor warning provisions (e.g., for vehicles, recreational vessels, and diesel engines).
OEHHA also made a few other changes, including incorporating alcoholic beverage exposure warnings into the restaurant warning sections (25607.5 and 25607.6) and providing a minor word change in the warning statements for furniture exposures (25607.13).
Additional context and details are available in the Final Statement of Reasons.
The Final Amendments reflect OEHHA’s attempts to clarify the Article 6 safe harbor warning regulations in response to a number of inquiries from the regulated community following the 2016 amendments. The 2016 amendments, as further modified by these Final Amendments, become fully operative on August 30, 2018 - less than a year from now. In the interim, businesses may opt to provide safe harbor warnings using the new methods and content provided in Article 6 (as further modified in the Final Amendments) or continue to use their existing warnings during the phase-in period. After August 30, 2018, all businesses that wish to take advantage of the safe harbor provisions of the regulations will need to use the warning methods and content in these new sections. Businesses should continue to monitor for further guidance or amendments from OEHHA in the run-up to the August 30, 2018 operative date.