In the July 2015 issue, we reported on food and beverage companies’ views on the overhaul of warning regulations under the Safe Drinking Water and Toxic Enforcement Act (colloquially known as Prop 65) proposed by the Office of Environmental Health Hazard Assessment (“OEHHA”) in California. In November 2015, OEHHA issued a replacement proposal and restarted its regulatory process. Since then, the agency has issued not one, but two supplemental drafts.¹ Food and beverage companies weighed in on each of the revisions.

The supplements address several concerns that stakeholders raised in written comments and at a public hearing:

• Numerous stakeholders, including those in the food and beverage industries, reiterated their objection that requiring a person providing a warning to have “determined [that] a warning is required” exceeds OEHHA’s authority under the statute. Indeed, although Prop 65 includes an exemption to the warning requirement if exposures are below a statutory threshold,² the statute does not require a manufacturer³ to claim the exemption. OEHHA has responded to these concerns, removing the objectionable text. Specific requirements for warnings now apply to substances or areas “for which the warning is being provided.” Consequently, the revised proposal should permit companies to issue warnings as a protective measure, even if actual exposures would not require a warning.
• The revisions also attempt to clarify that a person need list only one substance for each type of warning (cancer or reproductive harm). However, while the amended text improves on the original, uncertainty remains among stakeholders regarding whether the revised text gives the person providing the warning complete discretion to select the substance(s) to list.⁴ Because the requirement to name specific substances is a new feature of the proposed amendments, any uncertainty in the text will continue to cause concern for manufacturers.
• OEHHA further clarified that the proposed regulations would not impose higher burdens on parties using warnings developed in court-ordered settlements or judgments, removing the requirement to “fully” comply, rather than simply comply, with the order or judgment.
• The agency also narrowed the type of information that would trigger the multiple-language requirement, limiting it to “warnings, directions for use, ingredient lists, and nutritional information.” OEHHA clarified that a company’s name or location, if in a language other than English, would not trigger the translation requirement.
• The supplements no longer mandate minimum type size for warnings. Instead, the warnings must be “likely to be read and understood by an ordinary individual.”

While the changes outlined above are welcome to manufacturers, the supplements did not address a number of areas of concern and on which stakeholders had previously commented: ⁵

• Requiring that safe harbor warnings specifically list chemicals by name.
• Requiring the listing of two substances if the person is warning about both cancer and reproductive hazards.
• Restricting supplemental information that persons may include on a product label or in manuals, inserts or other associated written materials.
• Implementation concerns regarding the requirement for manufacturers to obtain confirmation that retailers have received their warning materials.
• Articulation of how and whether the general flexibility for on-product warnings also applies to specific safe harbor provisions, including those for food and beverage exposures.
• Clarification that customary methods of using electronic devices, such as clicking on hyperlinks or scanning a code, are not impermissibly requiring the purchaser to “seek out the warning,” thereby rendering the warning noncompliant.

The May notice implies that OEHHA will not issue additional supplements. Consequently, stakeholders will have to wait and see whether the final language addresses the remaining concerns.

¹ OEHHA issued the first supplement in March 2016 and the second in May 2016.
² HSC § 25249.10(c) exempts from the warning requirement an exposure that (i) “poses no significant risk assuming lifetime exposure at the level in question” for cancer, or (ii) “will have no observable effect assuming exposure at one thousand (1000) times the level in question” for reproductive toxicity.
³ “Manufacturer” in this article includes, consistent with the proposed rule, manufacturers, producers, packagers, importers, suppliers and distributors.
⁴ The same concern applies to specifying sources or areas to which warnings for environmental exposures apply.
⁵ OEHHA has stated it will address all three rounds of comments in the final rule. See Notice of Modification to Text of Proposed Regulation, Proposed Repeal of Article 6 and Adoption of New Article 6 – Proposition 65 Clear and Reasonable Warnings (May 18, 2016).