Proposition 65: OEHHA Proposes Significant Changes to “Short-Form” Warnings
On January 8, 2021, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed significant revisions to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations for “short-form” warnings.
When OEHHA’s revisions to the warning requirements were issued in 2016 (and in full effect as of August 30, 2018), OEHHA included a short-form warning option as an acceptable alternative to the revised requirements for consumer product exposure warnings. Many use this option. Its advantages include shorter language that can fit on a product’s label or packaging and the ability to provide a compliant warning without identifying at least one chemical listed under Prop 65 that triggers the warning, which is otherwise now a requirement for consumer product exposure warnings under OEHHA’s revised regulations.
Over time, OEHHA has expressed concerns regarding the reliance on short-form warnings when label/packaging space is not an issue, despite the fact that such use is compliant with OEHHA’s regulations and guidance. OEHHA’s proposal to amend its regulations will significantly constrict the circumstances when a short-form warning is permissible, as well as elongate the warning by now requiring the inclusion of a Prop 65 listed substance.
Comments on this proposal can be submitted to OEHHA no later than March 8, 2021. OEHHA also will schedule a public hearing if a request for such a hearing is received no later than February 22, 2021.
Information related to OEHHA’s past actions modifying Prop 65 warning regulations is available on our website, key phrase Proposition 65.
Background -- Short-Form Warning
OEHHA regulations (Section 25603(b)) provide an option for a “short-form” warning as an acceptable alternative to the revised 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, but importantly does not require a company to name a listed chemical within the text of the warning. OEHHA’s regulations (Section 25603(c)) state that a person providing a short-form warning “is not required to include within the text of the warning the name or names of a listed chemical.” That is one of the major differences, and for some the major advantage, of utilizing the short-form warning.
Thus, the three current short-form warning options, depending on whether the chemical(s) that trigger the warning are listed as carcinogens or reproductive toxicants, are as follows:
|⚠️||WARNING: Cancer -- www.P65Warnings.ca.gov|
|⚠️||WARNING: Reproductive Harm -- www.P65Warnings.ca.gov|
|⚠️||WARNING: Cancer and Reproductive Harm -- www.P65Warnings.ca.gov|
Under this option, the entire warning must be in a type size no smaller than the largest type size used for other consumer information on the product. In no case shall the warning appear in a type size smaller than six-point type.
OEHHA stated in its Initial Statement of Reasons (ISOR) (page 31) and its Final Statement of Reasons (page 72) that it believed the short-form warnings would be used more in cases when the full warning could not fit:
This provision proposes a very limited level of content to be included in an on-product warning to accommodate some product manufacturers’ stated concern that a longer warning message will simply not fit on the labeling or packaging of some small products. OEHHA is proposing a label that strikes a balance between this concern and the requirement in the statute that a person receive a warning prior to exposure. OEHHA believes that this approach will provide useful information to individuals while avoiding unwieldy on-product warnings. Further, the warning is clearer and more direct than the existing safe harbor warnings being used by many businesses. Recognizing the potentially limited space available for a warning, under subsection (c) the name of the listed chemical being warned for is not required.
OEHHA later in 2017 issued a Questions and Answers guidance document (revised July 2018) confirming that there is no limitation regarding the size of the package that can have a short-form warning.
Q29: Can a short-form warning label be used on any size product?
A29: OEHHA’s intent in adding the short-form warning to the safe harbor methods and content was to provide an alternative that could be used on small products or where space was limited. There is no express prohibition, however, on using the short-form warning on larger products. The warning content on the short-form warning must be in a type size no smaller than the largest type size used for other consumer information on the product and in no case smaller than 6-point type.
OEHHA modified its guidance on this issue when it released another revised Q&A document in May 2019:
Q25: Can a short-form warning label be used on any size product?
A25: OEHHA’s intent in providing the short-form warning option was to provide an alternative to be used on small products or where space was limited. There is currently no limitation on using the short-form warning on larger products. However, consumer product exposure warnings must be prominently displayed on a label and must be displayed with such conspicuousness as compared to other words, statements, designs, or devices on the label as to render the warning likely to be seen, read, and understood by an ordinary individual under customary conditions of purchase or use [Section 25601(c)]. The short-form warning must be in a type size no smaller than the largest type size used for other consumer information on the product and in no case smaller than 6-point type [Section 25602(a)(4)].
OEHHA may request additional information concerning a warning from businesses under Section 25205. This requested information includes the name(s) of the chemicals for which the warning is being provided, and the routes and levels of exposure. OEHHA may request this information, to provide to the public as appropriate on the warnings website. OEHHA has requested such information from some businesses using short-form warnings, and in other situations where OEHHA wants to understand why consumer product exposure warnings are being provided. OEHHA is monitoring use of this warning method to determine if the regulation should be amended.
OEHHA’s proposed amendments to its regulations at Section 25602(a)(4) specify that the short-form warning would only be permissible on a consumer product when the following three conditions are met:
The total surface area of the product available for labeling is five square inches or less;
The package shape or size cannot accommodate the full-length warning content described in Section 25603(a); and
The entire warning is printed in a type size no smaller than the largest type size used for other consumer information on the product, but in no case smaller than 6-point type.
The first two conditions are new, proposed by OEHHA to address its concern that businesses “use the short-form warning for products that can easily accommodate a longer warning.” ISOR at 4-5. The third condition has been modified to specify that the warning must be “printed,” which OEHHA states it added “for consistency with the requirement that the short-form warning be used only on product labels.” ISOR at 9.
OEHHA also is proposing to restrict the circumstances when a short-form warning can be used by eliminating entirely the option for Internet and catalog warnings. OEHHA states: “Because there are generally fewer space limitations on a webpage or in a catalog, use of a short-form warning is not appropriate in those contexts.” ISOR at 9.
OEHHA also is proposing to change the content of the warning language by eliminating the provision at Section 25603(c) stating that a short-form warning does not require the inclusion of the name(s) of a Prop 65 listed chemical, and instead proposing new short-form warning language to include a listed chemical.
WARNING: Cancer Risk From [NAME OF ONE OR MORE CHEMICALS KNOWN TO CAUSE CANCER] Exposure - www.P65Warnings.ca.gov
WARNING: Risk of Reproductive Harm From [NAME OF ONE OR MORE CHEMICALS KNOWN TO CAUSE REPRODUCTIVE TOXICITY] Exposure - www.P65Warnings.ca.gov
WARNING: Risk of Cancer From [NAME OF ONE OR MORE CHEMICALS KNOWN TO CAUSE CANCER] and Risk of Reproductive Harm From [NAME OF ONE OR MORE CHEMICALS KNOWN TO CAUSE REPRODUCTIVE TOXICITY] Exposure - www.P65Warnings.ca.gov
In the ISOR, OEHHA explains its efforts to understand the use of the short-form warning from businesses, as well as concerns raised by consumers from such use:
Some consumers have informed OEHHA of instances where a business representative told them that they are required to provide a Proposition 65 warning for all products sold in California but when asked would not provide the name of the listed chemical that the warning was provided for, because the business is not required to do so, because such information is “confidential”, or the specific chemical name is unknown. These practices are contrary to the statutory requirement to give clear and reasonable warnings for exposures to listed chemicals, and OEHHA’s stated intention in the 2016 rulemaking to provide more meaningful and informative warnings for consumer product exposures. ISOR at 7.
OEHHA has thus “determined that the concept of exposure is an important component of the full-length Proposition 65 safe harbor warnings and should likewise be incorporated in the short-form consumer product exposure warnings.” ISOR at 12. OEHHA states further: “While OEHHA still acknowledges the need for product warnings on very small packages, OEHHA does not believe the small size of a package justifies the failure to include any chemical-exposure information. ISOR at 8.
OEHHA also is proposing to revise the warning requirements applicable to food exposure warnings (Section 25607.2) by specifically permitting use of short-form warnings with the new language now proposed for consumer products (except the warning symbol is not required for food exposure warnings). OEHHA is further proposing that such warning be set off from other surrounding information and enclosed in a box to be consistent with the current full-length warning for food exposures.
All of these proposed amendments would be operative one year after the effective date of the amendments. The proposed amendments specify that a consumer product manufactured prior to the effective date that complies with the prior warning requirements is deemed to be “clear and reasonable” and compliant with the regulations. OEHHA states this “sell-through” provision “will help mitigate or avoid potential logistical issues and will allow manufacturers and retailers sufficient time to transition to the new content without the need to locate and re-label products already in the chain of commerce.” ISOR at 10.
These proposed amendments would significantly curtail the circumstances as to when it is permissible to use the short-form Prop 65 warning. Even when permissible, it also substantively alters the text of such warnings by requiring the inclusion of a Prop 65 chemical.
For comparative purposes, below are examples of the current short-form warning and how it compares to the proposed short-form warning and the warning that is required if the short-form warning is not utilized:
Current Short-Form Warning:
|⚠️||WARNING: Cancer -- www.P65Warnings.ca.gov|
Proposed Short-Form Warning:
|⚠️||WARNING: Cancer Risk From [CHEMICAL] Exposure - www.P65Warnings.ca.gov|
Current Full Length Warning:
|⚠️||WARNING: This product can expose you to chemicals including [CHEMICAL], which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.|
OEHHA’s view is the proposal will “help curb the current business practice of providing unnecessary “prophylactic” warnings without knowledge of any exposure to a listed chemical from the consumer product.” ISOR at 12. This view ignores the complicated circumstances some companies find themselves in when attempting to be compliant with Prop 65 regulations, but face difficulties in determining whether or how to test all products for trace levels (parts per million or parts per billion) of hundreds of Prop 65 listed substances.
Considering the proliferation of individual plaintiffs “acting in the public interest” to enforce Prop 65 (i.e., bounty hunters) and the quick shifting of burdens to companies to demonstrate compliance once in receipt of a 60-Day Notice regarding potential Prop 65 non-compliance, companies are urged to review the proposed amendments and assess whether these amendments, if issued in final, would affect their current compliance efforts with warning requirements.