On January 8, 2021, the California Office of Environmental Health Hazard Assessment (“OEHHA”) issued a notice of proposed rulemaking significantly limiting the use of the short-form warning as a safe harbor. Under the proposed regulation, the following changes are required:
- Limiting the use of the short-form warning to products with 5 square inches or less of label space for consumer information;
- Requiring at least one chemical to be identified in the warning;
- Eliminating short-form warnings in internet and catalogs; and
- Clarifying the use of short-form warnings for food, including the use of an offset boxed warning.
History of the Current Warning Requirements
In 2016, OEHHA, the California agency that administers Proposition 65, rewrote the regulations and provided options for warnings for consumer products: (a) a standard warning, including the identification of one or more of the listed chemicals and a link to an OEHHA website providing more information; or (b) a “short-form” alternative warning.
The short-form warning initially was to be used for products that did not have sufficient label space for the long-form warning, but the regulation did not explicitly limit the short-form to such products. Short-form warnings also became popular for e-commerce sites, due to the relative ease of implementation as compared to having to manage chemical-specific warnings to numerous products, and catalogs, given space and layout constraints.
Proposed Amendment
The new proposed warnings are:
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 and Reproductive Harm from [Name of one or more chemicals known to cause cancer and reproductive toxicity] Exposure – www.P65Warnings.ca.gov
With regard to internet and catalog warnings, the safe harbor would eliminate the use of short-form warnings if the product carries such warnings. If the regulation is adopted, internet and catalog warnings will need to be revised to provide the full safe harbor language in order to maintain compliance with the safe harbor (which is not mandatory but often treated by the enforcement community as such).
In addition, while the current regulation does not explicitly allow for a short-form warning for exposures to chemicals in food, the proposed amended regulations provide a new short-form warning for food that does not require the yellow triangle but must be set off from other information and included in a box. The language of the proposed short-form warning for food is otherwise very similar to the one for other products; the only real difference is that the website referred to is “www.P65Warnings.ca.gov/food.”
According to the Initial Statement of Reasons for the regulation, the agency determined that manufacturers are using the short-form warning to avoid litigation, contradictory to the purpose of Proposition 65 to inform consumers. According to OEHHA, “[t]he current short-form warning facilitates . . . ‘over-warning’ by providing businesses with safe harbor protection from enforcement actions without requiring the business to provide sufficient information to consumers.” The required “necessity” of the proposed regulation is: “to stop businesses’ use of the short-form warning described above on large packages, in catalogs and on-line to discourage its use to warn prophylactically.” Essentially, the agency is wanting to have businesses provide more meaningful and informative warnings, avoid over-warning, and require only use of the short form warning where the full-length warning will not fit on the label.
Takeaways and Monitoring the Changes
The business community is expected to aggressively oppose the amended regulation. If it does pass, the regulation will likely become effective one year from the effective date of the amendments and allow for products manufactured during that time to be grandfathered to allow for the current short-form warning.
OEHHA took public comments and held a hearing on March 11, 2021. (See here for Notice of Public Hearing and Extension of Public Comment Period.)
We will report on the results when announced by OEHHA; however, there are some tips and takeaways that businesses manufacturing, distributing, or selling consumer products in California should consider:
- Should the proposed amendments be adopted, warnings will need to include the identity of one or more chemicals on the Proposition 65 list. This change could increase the cost the overall burden of doing business in California.
- Current use of short-form warnings on product labeling/packaging may need to be revised to the long-form warnings, which could mean increased labeling and printing costs.
- For internet and catalog sales, long-form warnings will be required.
- Companies would be wise to be proactive and to understand and determine the chemical composition of the products they sell in California to determine whether they may be required to provide the more specific warnings anticipated by the new regulations. Companies doing business in California are strongly advised to consider developing a Proposition 65 compliance plan is to manage this risk.
We will continue to monitor all developments with these proposed amendments to the short-form warnings under Proposition 65 and publish updates as developments become available.