On April 5, 2022, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a notice proposing additional modifications to its proposal to modify its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations for “short-form” warnings (Notice). OEHHA first proposed to change the short-form warning requirements on January 8, 2021. On December 13, 2021, OEHHA issued a notice proposing modifications to the revisions in its first proposal. More information regarding the January 8, 2021, proposal and the December 13, 2021, modifications is available on our blog. OEHHA is requesting comments on its Notice and the modifications to the proposed regulatory text to be submitted no later than April 20, 2022.
Background
OEHHA’s regulations (Section 25603(b)) provide an option for a “short-form” warning as an acceptable alternative to the general requirements for consumer product exposure warnings. This option requires the hazard symbol, the word “warning” in capital letters and bold print — WARNING — and a reference to OEHHA’s website. There is no requirement as to the conditions when the short-form warning can be used (e.g., limited label space). Importantly, the short-form warning does not require a company to name a listed chemical within the text of the warning.
OEHHA’s January 8, 2021, proposed revisions sought to curtail the circumstances when the short-form warning could be used, including requiring that labels be smaller than a certain size (i.e., five square inches or less) and eliminating the short-form warning option for Internet and catalog warnings. If the criteria could be satisfied, OEHHA further proposed to modify the short-form warning language, including the requirement to list a Prop 65 substance.
Following OEHHA’s review of comments, OEHHA proposed certain changes. Regarding the criteria for when the short-form warning could be used, OEHHA proposed to increase the label size requirement to 12 square inches. In addition, OEHHA rescinded its initial proposal to prohibit using the short-form warning online and in catalogs. Regarding the short-form warning language, OEHHA proposed two additional changes:
- Instead of only permitting the word “WARNING” in capital letters and bold print, OEHHA is proposing to add two options: “CA WARNING” or “CALIFORNIA WARNING.” OEHHA states this proposal is to “allow businesses to make clear that the warning is being given pursuant to California law.”
- OEHHA provided an additional warning option that it states “more directly addresses exposure to carcinogens or reproductive toxicants.”
Current Modifications
In its April 5, 2022, Notice, OEHHA has proposed further modifications to its short-form warning regulations:
- Section 25602(a)(4) — Label Size: OEHHA proposes to eliminate any size or package shape conditions for when the short-form warning can be used. These changes mean that the short-form warning can be “used on product labels of any size, regardless of package size and shape.” Addendum to the Initial Statement of Reasons at 3 (Addendum). OEHHA states it removed this limitation because of the “difficulty in determining compliance with the provision because of lack of specificity in how to determine whether the package shape and label could or could not accommodate the full-length warning.” Addendum at 4.
- Section 25602(a)(4) — Font Size: OEHHA further proposes to remove the requirement that the font type size be the same as the largest type size providing consumer information. OEHHA states that it is proposing this change “because recent federal requirements would in some cases result in oversized short-form warnings, and provide a disincentive to adding Proposition 65 warnings to label[s], an important method for giving warning.” Addendum at 4-5. OEHHA has instead added regulatory language to specify that a short-form warning have a type size that complies with Section 25601(c), which is the existing requirement that the type size be such as “to render the warning likely to be seen, read, and understood by an ordinary individual under customary conditions of purchase or use.”
- Sections 25602(e) and 25607.2(c) — Effective Date: OEHHA proposes to change the date that the regulation becomes operative to two years from the effective date rather than the one year previously proposed. The additional time provided is a direct response to concerns raised by industry that the one-year time period was insufficient to implement the changes.
- Sections 25603(b) and 25607.2(b) — “Expose” Language: OEHHA proposes to change the warning language from “exposes you to” to “can expose you to” so that the language conforms with the general content language in the general consumer warning at Section 25603. In proposing this change, OEHHA states that it considered that “some products might result in exposures requiring warning to some people but not others, depending on how they are used” as well as that “some products contain varying levels of a listed chemical, so any individual sample of the product may or may not actually expose the consumer.”
OEHHA also proposes to correct the regulatory text regarding the warning to state “[name of chemical]” instead of “[name of one or more chemicals known to …].” OEHHA states the language is intended to clarify “that the name of only one chemical is required in each of the parentheticals.” Addendum at 2.
Based on the current proposal including the modifications from January 8, 2021, and April 5, 2022, the short-form warning options are as follows:
For exposures to listed carcinogens:
WARNING [OR CA WARNING OR CALIFORNIA WARNING]: Cancer risk from exposure to [name of chemical] — www.P65Warnings.ca.gov
or
WARNING [OR CA WARNING OR CALIFORNIA WARNING]: Can expose you to [name of chemical], a carcinogen — www.P65Warnings.ca.gov
For exposures to listed reproductive toxicants:
WARNING [OR CA WARNING OR CALIFORNIA WARNING]: Risk of reproductive harm from exposure to [name of chemical] — www.P65Warnings.ca.gov
or
WARNING [OR CA WARNING OR CALIFORNIA WARNING]: Can expose you to [name of chemical], a reproductive toxicant — www.P65Warnings.ca.gov
For exposures to both listed carcinogens and reproductive toxicants:
WARNING [OR CA WARNING OR CALIFORNIA WARNING]: Cancer risk from [name of chemical] and of reproductive harm from exposure to [name of chemical] — www.P65Warnings.ca.gov
or
WARNING [OR CA WARNING OR CALIFORNIA WARNING]: Can expose you to [name of chemical], a carcinogen, and [name of chemical], a reproductive toxicant — www.P65Warnings.ca.gov
For exposures to a chemical that is listed as both a carcinogen and a reproductive toxicant:
WARNING [OR CA WARNING OR CALIFORNIA WARNING]: Cancer risk and reproductive harm from [name of chemical] exposure — www.P65Warnings.ca.gov
or
WARNING [OR CA WARNING OR CALIFORNIA WARNING]: Can expose you to [name of chemical], a carcinogen and a reproductive toxicant — www.P65Warnings.ca.gov
Commentary
The proposed modifications are incremental improvements to OEHHA’s initial and additional modified proposals. Issues related to label sizes and the one-year compliance period were important issues about which industry raised significant concerns. The short-form warning language if adopted will continue to invite substantial changes in requiring the inclusion of a Prop 65 listed substance, but the elimination of the size restrictions and font requirements, as well as permitting short-form warnings on the Internet and in catalogs when the label also uses the short-form warning, means that the short-form warning option remains viable.
OEHHA has extended the compliance date to two years, based on the facts that the two-year time period is the same time that was provided when OEHHA proposed substantial amendments to the Prop 65 requirements in 2016 and that “[b]usinesses were able to achieve that timeframe.” Addendum at 6. While accurate, the label changes adopted in 2016 created significant work, and it was no small feat for companies to assess the implications of the regulations and implement necessary label changes. Companies currently using the short-form warning will have similar issues and should begin to assess how these amendments, assuming they are issued in final, will affect current compliance efforts with warning requirements.