On January 8, 2021, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a Notice of Proposed Rulemaking to amend the current Proposition 65 safe harbor "short-form" warnings. The amendments would change the content of the warnings and the method of use in significant ways. Comments on the proposed amendments are due on or before March 8, 2021.
Background on Prop 65 Warnings
Proposition 65 prohibits businesses from exposing California consumers to certain levels of chemicals identified by the state to cause cancer and/or reproductive harm, without a warning. The regulations specify "safe harbor" warning language that can be provided with a product to ensure compliance. In 2018, OEHHA's most recent amendments to the Proposition 65 warning regulations went into effect, which provided alternative "short-form" safe harbor warnings. These warnings allow the use of a cautionary symbol (exclamation point surrounded by a yellow triangle), the word "WARNING" in all capital letters and bold print, the end-point (cancer and/or reproductive harm), and the Proposition 65 warning website (www.P65Warnings.ca.gov). The following is an example of a compliant short-form warning:
WARNING: Cancer and Reproductive Harm – www.P65Warnings.ca.gov.
Notable Proposed Changes
In its notice, OEHHA alleges that it issued the amendments as a result of the "widespread use of short-form warnings in ways that were not intended and do not further the purposes of Proposition 65" and "numerous inquiries" about when the short-form warning could be used. Additionally, OEHHA was concerned that the short-form warnings were being added prophylactically by businesses without adequate consideration of the potential for exposure to Proposition 65-listed chemicals, which OEHHA believes to be inappropriate. OEHHA identified numerous examples of such warnings it believed were being used in this manner, demonstrating that OEHHA has been and will continue to scrutinize the adequacy and basis of warnings for consumer products sold in California. Below are some notable proposed changes to the current regulations that could go into effect.
Restrictions on Use of Warning: The new amendments only allow the use of short-form warnings on products with five square inches or less of label space, and where the package shape or size cannot accommodate the long-form warning. This is in contrast to the current regulations, which allow businesses to determine which warning they want to use, regardless of the size of the label, or size or shape of the package.
Content Changes: The amendments propose to change the content of the warnings. In addition to the cautionary symbol, "warning" language, and website address, the warnings must include at least one chemical in the product known to cause cancer or reproductive toxicity. The warning is also more descriptive, indicating to the consumer that there is a "cancer risk" and/or "risk of reproductive harm" from the chemical(s). For example, for exposures to both listed carcinogens and reproductive toxicants, the following warning would be required:
WARNING: Risk of Cancer from [Name of one or more chemicals known to cause cancer] And Reproductive Harm From [Name of one or more chemicals known to cause reproductive toxicity] Exposure – www.P65Warnings.ca.gov
Clarifications for Food Products: The amendments clarify how short-form warnings can be used for food products. Short-form warnings on food products are permissible only if the warning includes the word “WARNING” in all capital letters and bold print, the addition of at least one chemical in the product known to cause cancer or reproductive toxicity, and language indicating to the consumer that there is a "cancer risk" and/or "risk of reproductive harm" from the chemical(s). The warning must also identify a website address, www.P65Warnings.ca.gov/food, and must be set off from other surrounding information and enclosed in a box. For example, for exposures to both listed carcinogens and reproductive toxicants, the following warning would be required:
WARNING: Risk of Cancer from [Name of one or more chemicals known to cause cancer] And Reproductive Harm From [Name of one or more chemicals known to cause reproductive toxicity] Exposure – www.P65Warnings.ca.gov/food
Internet and Catalog Warnings: The amendments eliminate the use of short-form warnings for internet and catalog warnings, which are permissible under the current regulations.
Phase-In Period/Sell-Through Period: There is a one year phase-in period for businesses that choose to use the short-form warnings, which starts to run from the date the amendments become effective. Further, in an attempt to avoid recalls, there is an unlimited sell-through period for products that contained Proposition 65-compliant warnings at the time of manufacture.
Potential Negative Impacts
Additional Compliance Costs: Businesses will incur additional costs to identify the specific chemicals present in the product and their endpoint, to update product packaging/labeling and internet websites/catalogs accordingly, and to notify any downstream customers of the changes.
Additional Litigation Costs: The changes to warnings will almost certainly spark additional litigation against businesses using the prior short-form warnings, adding to already significant litigation expenses.
Negative Publicity/Loss of Goodwill: Proposition 65 warnings and litigation can adversely affect public perception of the product, reduce sales and revenue, trigger additional legal concerns, and focus additional scrutiny on other products.
The Changes Are Unlikely to Have an Added Benefit to Consumers or Businesses
As OEHHA indicates that these amendments are intended to "correct course" and align the short-form warnings with its original intent, the changes have been anticipated for some time. However, these amendments effectively make the short-form warnings, which are intended to be just that – short – useless, as there is little difference between the two warning options. The changes will be burdensome without helping the consumers or the regulated community. The new warnings are longer, but provide little additional information to identify the actual level of risk involved in handling or consuming the product. For businesses, the amendments remove one of the most straightforward aspects of the current regulations, and serve to make the compliance process even more complicated and expensive; once again, businesses will need to redesign and reprint labels and alter websites – where additional real estate is often hard to come by – at a significant cost. This may also further open the door to private enforcement actions, and costs passed down to the consumer – all without any added benefit to Californians. While the public comment period remains open, the amendments are expected to pass without issue.