On January 12, 2015, California’s Office of Environmental Health and Hazard Assessment (“OEHHA”) released the long anticipated Notice of Proposed Rulemaking that proposes changes to the warning requirements under Proposition 65’s (“Prop 65”) implementing regulations. The proposed regulations would establish a new mandatory regulation addressing the responsibility of product manufacturers and others in the chain of distribution and provide guidance on the methods and content for safe harbor warnings, including the statement that a person “can be exposed” to a listed chemical. Significantly, the proposed amendments include an update to the current safe harbor warning and require specific identification of certain chemicals on warning labels.
Background
OEHHA originally published pre-regulatory proposed changes last spring and subsequently held a workshop and accepted comments from the public. The proposed regulatory amendments issued this week reflect some modifications to the original proposal, but continue to contain significant changes that will impact companies selling products in the state of California, including manufacturers, distributors, and retailers. OEHHA has stated that it is proposing these changes to address concerns that the current safe harbor Prop 65 warnings lack the necessary specificity to ensure that the public receives useful information about potential exposures.
Summary of the Proposed Changes
Under the current regulations, warning language stating that the “product contains a chemical known to the State of California to cause” cancer, birth defects, and/or other reproductive harm is permitted. The proposed regulations would require that Prop 65 warnings contain the following information:
- a symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline (though the symbol may be printed in black and white if other signage or labeling for the product is not in color);
- the word “WARNING” in all capital letters and bold print;
- the language: “This product can expose you to a chemical…”;
- specific warning language based upon the potential physiological effect of exposure (e.g., cause cancer and/or birth defects or other reproductive harm);
- specific identification of certain chemicals, as discussed below; and
- reference to an OEHHA Prop 65 website.
As noted above, the proposed regulations also contemplate that warnings specifically identify the following chemicals, to the extent exposure to such a chemical requires a warning under Prop 65:
- acrylamide
- arsenic
- benzene
- cadmium
- carbon monoxide
- chlorinated tris
- formaldehyde
- hexavalent chromium
- lead
- mercury
- methylene chloride
- phthalates
This represents a significant departure from the current regulations, which do not require that a company specifically identify in the Prop 65 warning which chemicals are present in the product. In selecting these chemicals for identification, OEHHA noted that it considered the following factors:
- widespread prevalence of the listed chemical in products;
- potential for significant exposure to the listed chemical through human interactions with products;
- recent Prop 65 enforcement activity;
- recognizability of the chemical name among the general public; and
- the availability of resources to the public about toxicity, doses of concern, and ways to prevent or reduce exposure.
Proposed Rule Changes Specific to Food Products
The proposed changes would also apply to food products, with two exceptions. First, the warning symbol would not be required for food products. Second, the warning language is modified for food products to explain that exposures occur through consumption of a food product (“[c]onsuming this product can expose you to”). OEHHA confirmed that companies may include additional contextual information to supplement the Prop 65 warning, as long as it does not contradict, dilute, or diminish the warning. OEHHA noted that it encourages companies to include in the warning information about ways to reduce exposure.
Additionally, the proposed regulations contain specific guidelines for other products and exposure areas, such as prescription drugs, dental products, raw wood, furniture products, diesel engines, passenger vehicles, parking facilities, amusement parks, petroleum products, service stations, vehicle repair stations, and designated smoking areas.
Next Steps
As proposed, the amendments would not take effect for two years to provide manufacturers, distributors, and retailers a “sell through” period. Nonetheless, companies should stay apprised of the developments with regard to the potential changes to the Prop 65 warnings, since some of the proposed changes (especially the proposal to require that the warnings specifically identify certain chemicals) may require a fair amount of planning to ensure compliance.
A public hearing on the proposed changes will be held on March 25, 2015 at 10:00 a.m. at the California Environmental Protection Agency Building, 1001 I Street, 2nd Floor, Sacramento, CA. The comment period for this proposed regulatory action closes on April 8, 2015. More information can be found at OEHHA’s Prop 65 website.
Authored by Melissa A. Jones and Bao M. Vu at Stoel Rives LLP.