On January 8, 2021, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced proposed amendments to Proposition 65 warning regulations that would limit use of the short-form version of the safe harbor warning.
Proposition 65, California’s Safe Drinking Water and Toxic Enforcement Act of 1986, mandates that businesses that sell consumer products—including food, cosmetics, and OTC drugs—notify Californians about possible exposure via a clear and reasonable warning about certain chemicals that have been identified as substances that cause cancer or reproductive toxicity.
Since the original warning requirements took effect in 1988, most Proposition 65 warnings simply stated that a chemical is present that causes cancer or reproductive harm, but they did not identify the chemical or provide specific information about how a person may be exposed or ways to reduce or eliminate exposure to it.
New OEHHA regulations, adopted in August 2016 (and effective in August 2018) changed the “safe harbor warning” that was deemed to meet the requirements for a clear and reasonable warning. Importantly, the new safe harbor warning was to identify at least one chemical that prompted the warning. In addition, the warning statement would no longer state “contains” the chemical but instead “can expose you to” a Proposition 65 chemical. The regulations did provide for a short-form version of the Proposition 65 warning. The key difference between these two warning statements is that the long-form warning requires that the business specifically must name at least one Proposition 65 chemical that could result in exposure from the product’s use, whereas the short form warning requires only a statement of the potential health hazard. For example, a long-form warning for a product containing a chemical listed as a carcinogen could read:
WARNING: This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
A short-form warning for the same product could read:
WARNING: Cancer – www.P65Warnings.ca.gov
Not surprisingly, many businesses chose to use a short-form warning. In its “Initial Statement of Reasons” OEHHA asserts that the short-form warnings are used in ways that were not intended and do not further the purposes of Proposition 65. Specifically, the intent of the 2016 updates had been to provide consumers with more meaningful and informative warnings, avoid over-warning, and limit the use of the short form warning where the full-length warning will not fit on the label. Therefore, OEHHA is proposing amendments that limit and revise the use of short-form warnings. Proposed changes include:
- Allow the short-form warning only
(a) on products with 5 square inches or less of “label space” and
(b) when the standard warning will not fit.
- Prohibit the short-form warning for internet and catalog sales. This prohibition would apply even if the actual product label is eligible and contains the short-form warning.
- Add a requirement that the name of at least one chemical per relevant toxicity endpoint be included in the short-form warning; and
- Include the words “Risk” and “Exposure” in the warning.
Under the proposal, the new safe harbor warning for a product containing a potential carcinogen would read “ WARNING: Cancer Risk from [insert chemical name] Exposure – www.P65Warnings.ca.gov.”
The existing minimum type size requirements under the current regulations would not change. In addition to requiring more transparency concerning the identity of chemicals in the warning, OEHHA hopes the proposed changes will dissuade businesses from over-warning.
OEHHA is accepting comments on the proposal through March 8, 2021.