Just when businesses thought they had figured out their Proposition 65 compliance strategies, the State of California, through the Office of Environmental Health Hazard Assessment (OEHHA), has proposed a substantial change that will drastically limit the use of the short-form safe harbor warning first authorized in 2018. In addition, for manufacturers, importers, distributors, and retailers of consumer products, this revision will eliminate the essential benefits of using the short-form warning for products containing a listed carcinogen and/or reproductive toxicant. As drafted, the proposal would modify the approved short-form warning language and limit its use as follows:
- Only allow the use of the short-form warning on products with five square inches or less of label space and only when the package shape or size cannot accommodate the full warning.
- Require that the name of at least one chemical be included in the short-form warning, where both risks are present in at least one of the chemicals from each type.
- Eliminate the use of short-form warnings for internet and catalog warnings; only long-form warnings could be used in these formats.
If enacted, the proposed regulation would provide a one-year phase-in period for existing products. Further, the proposal would allow an unlimited sell-through period for products that had compliant warnings when they were manufactured, thus allowing businesses to avoid recalling items in the stream of commerce to apply the modified short-form warning.
An example of the current short-form warning for a listed carcinogen is:
WARNING: Cancer - www.P65Warnings.ca.gov
The proposal would require this:
WARNING: Cancer Risk From Diisononyl Phthalate (DINP) Exposure – www.P65Warnings.ca.gov.
For a consumer product containing two chemicals with two separate exposure risks, the proposal would require:
WARNING: Cancer Risk From Formaldehyde and Reproductive Risk From Toluene Exposure - www.P65Warnings.ca.gov.
In its Initial Statement of Reasons, OEHHA states that the proposed regulation is necessary to stop businesses’ use of the short-form warning on large packages, in catalogs, and on-line (where there are not the same space limitations), and to discourage its use to warn prophylactically by requiring that the short-form warning name at least one chemical and clarify that use of the product can cause a chemical exposure.
The proposal raises numerous questions about how the regulation would apply to products that are too small for the new version of the short-form warning, the impact the rule would have on prior settlements and pending claims, and most importantly, how businesses will react.
This proposal will have a significant impact on businesses up and down the supply chain. Most had totally revamped their approach to Proposition 65 compliance based on the 2018 safe harbor language. Changes in business practices reverberated across the supplier-seller relationship in response to questions and concerns about testing, chemical content, supplier representations, warranties, indemnity, and risk management. Now, just as the industry seemed to be learning how to manage under the 2018 rules, this proposal has the potential to change everything.
The deadline to request a public hearing is February 22, 2021. As of January 20, 2021, there is no indication that a public hearing has been requested.
The last day for the public to submit written comments is March 8, 2021. Given the anticipated volume of comments, it seems unlikely that a final rule will be adopted before the summer of 2021.