On October 27, 2023, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a notice proposing changes to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations for “short-form” warnings (Notice).
OEHHA first proposed changes to the short-form warning requirements on January 8, 2021, with modifications proposed on December 13, 2021, and April 5, 2022. Industry was harshly critical of OEHHA’s proposal in written comments and during a March 11, 2021, hearing. Industry argued that OEHHA’s proposal was unwarranted and its concerns with the current warning requirements unfounded. Industry stakeholders also expressed frustration with the expected significant resources and costs that implementation of these changes would inspire. On May 20, 2022, OEHHA announced that it would be unable to complete the rulemaking process within the one-year deadline required under California law (Cal. Gov’t Code § 11346.4(b)), and thus the rulemaking would lapse. OEHHAstated in its May 20, 2022, notice entitled “May 2022 Status Update for Clear and Reasonable Warnings — Short Form: Completion of Proposed Rulemaking” that it “intends to restart the rulemaking process on the short-form with a new regulatory proposal, informed by comments on the previous proposal.”
OEHHA has made good on its intentions and has now re-proposed changes to the short-form warning requirements. Written comments on the proposed changes are due no later than December 20, 2023. OEHHA also has scheduled a public hearing on December 13, 2023, at 10:00 a.m. (PST). The hearing will be a hybrid format, allowing for in person and remote participation.
Proposed Modifications
OEHHA’s current 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 Prop 65 listed chemical within the text of the warning.
OEHHA’s proposal would change virtually all aspects of the short-form warning, including limitations on the circumstances when the short-form warning could be used, and, if the criteria could be satisfied, modifications to the short-form warning language, including but not limited to the requirement to list a Prop 65 substance.
Conspicuousness and Font Size
In its Initial Statement of Reasons (ISOR), OEHHA provides anecdotal examples of short-form warnings being used in circumstances where there are no space limitations. See ISOR at 7 and Appendix A. OEHHA further states that it “has become aware of many cases where a warning containing safe harbor content is being given in such a manner that the warning is not easily seen.” ISOR at 12.
Although OEHHA is not proposing a label size requirement as it had in its previous proposals, it is proposing at Section 25602(a)(4) tospecify and clarify 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.” In addition, OEHHA retains the existing requirement that in no case shall the warning appear in a type size smaller than six-point type. Regarding these requirements, OEHHA states:
| The reference to section 25601(c) is intended to promote conspicuous warnings and to affirm that the 6-point type is not intended to be a de facto acceptable floor for the type size of a warning. The warning type size should render the warning conspicuous in relation to the other items on the product label. A 6-point type size warning is not prominently displayed or conspicuous on the back side or bottom of an 8-foot by 4-foot refrigerator box, but it may be on the back and bottom of a 2-inch by 6-inch package of glue. |
ISOR at 16-17.
Internet and Catalog Purchases
OEHHA provides further requirements for when a short-form warning is permissible for Internet and catalog purchases. OEHHA is proposing to divide Subsection 25602(b) into two further subsections: Subsection 25602(b)(1), which clarifies options to provide warnings on the Internet to the purchaser prior to purchase; and Subsection 25602(b)(2), which clarifies options to provide warnings to consumers upon delivery. The same is proposed for catalog purchases, with Subsection 25602(c)(1) clarifying options to provide warnings on the Internet to the purchaser prior to purchase; and Subsection 25602(c)(2) clarifying options to provide warnings to consumers upon delivery.
For Internet warnings prior to purchase, the proposed regulations would no longer tie the short-form warning to circumstances where the short-form warning appears on the consumer product. Instead, OEHHA states the proposed amendments clarify and expand the three existing warning options:
- Subsection (b)(1)(A) — A warning can be placed “on the product display page.” OEHHA states the proposed amendment is intended to make clear that businesses “have the option to place the entire warning on the webpage where the product is displayed (e.g., without requiring the consumer to click to another webpage).”
- Subsection (b)(1)(B) — A warning can be provided via hyperlink using signal words. As in prior proposals, the current proposed amendment provides the signal words “CA WARNING” or “CALIFORNIA WARNING” as alternatives to the existing signal word “WARNING.” OEHHA states that adding the choice of signal words “CA WARNING” and “CALIFORNIA WARNING” also allows a business that is selling products on the Internet to target the warning to California consumers and to clarify that the warning is being given pursuant to California law.
- Subsection (b)(1)(C) — A warning can be made by using “an otherwise prominently displayed warning made to the purchaser prior to completing the purchase.” This existing option already includes, for instance, a pop-up warning during the purchase of the item, rather than an image on the product display page as in subsection (b)(1)(A). The reference to the short-form warning is deleted because it is clarified elsewhere.
OEHHA further states:
| OEHHA is also clarifying that a specific tailored warning for a product exposure in “Section 25607 et seq.” may, and in some cases must, also be used on the internet. For most but not all exposures covered by tailored warnings, the tailored safe harbor content is necessary to fall within the safe harbor. Where it is not, a business may use the content for the tailored warning (section 25607 et seq.), the short-form (subsection 25603(b)), or the full-length warning (subsection 25603(a)) for internet warnings. |
ISOR at 18.
For catalog warnings prior to purchase, the proposed regulations state that a warning must comply with content requirements at Section 25603 or 25607 and be provided in the catalog in a manner “that clearly associates it with the item being purchased.”
For Internet and catalog warnings upon delivery, newly proposed language at Section 25602(b)(2) and (c)(2) states:
| the warning must also be included: on or with the product when delivered to the consumer using one or more of the methods in Section 25602(a)(3) or Section 25602(a)(4); on labeling accompanying the product as defined in Section 25600.1(j); or as otherwise specified in Section 25607 et seq. |
OEHHA states this new language regarding warnings upon delivery is intended to clarify the options available: (1) a full-length warning on a product label or affixed to the immediate packaging or wrapper consistent with Section 25602(a)(3); (2) a short-form warning on a product label or affixed to the immediate packaging or wrapper consistent with the proposed amended Section 25602(a)(4); (3) a warning on labeling accompanying the product as defined in Section 25600.1(j) (“‘[l]abeling’ means any written, printed, graphic, or electronically provided communication that accompanies a product, such as a package insert.”) or (4) tailored, product-specific warnings (e.g., alcoholic beverages) consistent with Section 25607.
Proposed Short-Form Warning Language
OEHHA is continuing its effort from its prior proposals to require the inclusion of a Prop 65 listed substance(s) in the short-form warning. OEHHA states that this proposal is to make short-form warnings “more informative.”
The current proposal for short-form warning options is the same as those last proposed on April 5, 2022, 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
Tailored Warnings
OEHHA is proposing modifications to the current regulation for Food Exposure Warnings at Section 25607.2 to clarify that short-form warnings are permissible for food products and the required language for such warnings.
OEHHA also proposes four new sections to provide tailored safe harbor warnings for passenger or off-highway motor vehicle parts exposures and recreational marine vessel parts exposures:
- Passenger or Off-Highway Motor Vehicle Parts Exposure Warnings — Section 25607.50 and 25607.51
- Recreational Marine Vessel Parts Exposure Warnings — Section 25607.52 and 25607.53
OEHHA determined based on feedback received from its 2021-2022 efforts to amend the short-form provisions that “passenger or off-highway motor vehicle and recreational marine vessel parts manufacturers, importers, distributors, retailers, and California consumers would benefit from providing these businesses with the option of using tailored Proposition 65 warnings.” ISOR at 5-6. Based on the number of potential parts at issue and varying exposures, OEHHA is now proposing regulations specific to replacement parts purchased and installed by consumers. Tailored warning provisions already exist for the vehicles themselves (Sections 25607.18 and 25607.19). An example of the proposed tailored warning for exposures to recreational marine vessel parts, including the language from proposed section 25607.53(a)(3) would be as follows:
WARNING: Handling recreational marine vessel parts can expose you to chemicals such as phthalates and lead, which can cause cancer and reproductive harm. To minimize exposure, service the vessel outdoors or in a well-ventilated area, wear gloves, and wash your hands. For more information see www.P65Warnings.ca.gov/marine-vessel-parts.
Effective Date
OEHHA proposes at Sections 25603(c) to change the date that the regulation becomes operative to two years from the effective date rather than the one-year period initially proposed. The additional time provided is a direct response to concerns raised by industry that the one-year period was insufficient to implement the changes.
To limit costs to businesses, OEHHA also provides an unlimited sell-through period for products manufactured and labeled prior to the effective date of the amendments. With regard to those costs, OEHHA estimates that the “short-form amendment will result in costs associated with changing existing short-form warning labels and internet and catalog warnings totaling approximately $14,538,327.67, or $4,273.46 per business.” ISOR at 46.
Commentary
OEHHA states in the ISOR several times that revisions are needed because “many businesses are using the short-form warning prophylactically because it protects from potential litigation.” See, e.g., ISOR at 7, 10, 25. OEHHA further states: “Prophylactic warnings confuse consumers and dilute the overall value of Proposition 65 warnings, which should only be provided for knowing and intentional exposures to a significant amount of a listed chemical.” ISOR at 42.
It is inaccurate to state that warnings are required only for exposures to a “significant amount of a listed chemical.” A consumer advocacy group, private citizen, or law firm need only test and detect a trace amount of any Prop 65 listed substance on a consumer product without a Prop 65 warning to establish a prima facie case and send a 30-day notice. The onus then falls on the company(ies) to defend itself, and even when there is clear evidence that exposures are not above established safe harbor limits and no Prop 65 warning is warranted, companies tend to settle to avoid the substantial time and costs to defend such actions. It is curious why OEHHA’s not-so-subtle criticism of industry’s current use of the short form so misses the mark.
If OEHHA is truly committed to ensuring that Prop 65 warnings are provided only when required under the regulations, it would revise the rules (e.g., establish certain de minimis thresholds, provide opportunities to cure, streamline the safe use determination (SUD) process for exposure assessment reviews) to address the alleged overuse and clear abuse of private attorney actions under Prop 65.
In the meantime, companies potentially affected by this proposal should review carefully the changes proposed and consider submitting written comments and/or participating in the December 13, 2023, hearing. Issues related to the method of transmission of short-form warnings, the content of short-form warning language, the efforts taken to ensure compliance, and the time and costs to implement OEHHA’s proposed changes are important topics to be addressed.