California’s Office of Environmental Health Hazard Assessment (OEHHA) has released another draft of its proposed amendments to the Proposition 65 warning regulations. This is the third draft OEHHA has released for public comment since it began the process to amend the regulations in 2014.

Prop. 65 prohibits businesses from “knowingly and intentionally” exposing California consumers to a chemical known to the state of California to cause cancer or reproductive harm without first providing a “clear and reasonable warning.” (Health & Safety Code § 25249.6.) The draft regulations would substantially change the requirements for what constitutes a clear and reasonable warning.

If adopted, the regulations would take effect two years later. Any products with label warnings manufactured prior to adoption of the new regulations would continue to be protected from liability. The new draft regulations also clarify that parties to existing settlement agreements or court-approved consent judgments could continue to provide warnings that comply with those agreements or orders.

Proposed Regulations Seek to Reduce Burden on Retailers to Provide Warnings

The draft regulations seek to put the primary responsibility for providing warnings on product manufacturers or suppliers, who must either label their products with any required warnings or provide notice and warning materials to retailers. The manufacturer or supplier would have to specifically identify the product(s) requiring a warning, provide all necessary warning materials, receive confirmation of receipt from the retailer, and renew the notice every six months for the first year and annually thereafter.

A retailer could still be held responsible for failure to provide a required warning for the retailer’s private label products or where the retailer has:

  • knowingly introduced or caused a listed chemical to be created in a product ;
  • covered or obscured a product’s label warning;
  • received warning information and materials from the manufacturer or supplier but sold the product without supplying the warning; or
  • has actual knowledge of the potential consumer exposure requiring the warning, and there is no manufacturer or supplier who is subject to Prop. 65 (has 10 or more employees) and a place of business in California or a designated agent for service of process in California.

The draft regulations would also add a requirement that the manufacturer or other supplier of a product must notify a retailer within 90 days if a new chemical or endpoint (cancer or reproductive toxicity) is required to be included in a product warning.

Content and Method of Transmission of Safe Harbor Warnings Would Be Altered

The draft regulations would create new safe harbor warning requirements involving use of a black exclamation point in a yellow equilateral triangle with a black outline. Where a sign or label does not use the color yellow, the warning could be provided in black and white. The triangle should be placed next to the warning, in a size no smaller than the word “WARNING,” which should appear in all capital letters and bold print. The warning should state:

WARNING: This product can expose you to chemicals such as [one or more listed chemicals] which is known to the State of California to cause cancer [or birth defects or other reproductive harm]. For more information, go to www.P65Warnings.ca.gov/product.

Warnings provided on product labels could be shortened as follows:

WARNING: Cancer – www.P65Warnings.ca.gov/product

WARNING: Reproductive Harm - www.P65Warnings.ca.gov/product

For food products, the draft regulations provide that the warning should state:

WARNING: Consuming this product can expose you to chemicals such as [name of chemicals] which is known to the State of California to cause cancer [or birth defects or other reproductive harm].   For more information, go to www.P65Warnings.ca.gov/product.

If the warning is provided on a food product label, the draft regulations specify the warning should be set off in a box.

Warnings to Specifically Name a Chemical Triggering the Warning Requirement

The draft regulations would require that a warning list the name for one or more chemicals for which the warning is being provided. This is a departure from the current regulations, which do not require the name of any chemical to be included, and from prior regulations, which had proposed to require that a chemical be included only if it was one of 12 particular chemicals.

The draft regulations also specify that a warning may include supplemental information only to the extent that it contains the source of the exposure or explains how to reduce or avoid exposure.  

The regulations would require that warnings on product labels be provided in type size no smaller than the largest type size used for other consumer information, and in no less than 6 point type size.

If any label, labeling or sign provides consumer information in a language other than English, the warning must be provided in the same language.

Warnings Required Prior to Internet Sales to California Customers

For Internet sales, the draft regulations provide that the warning should be provided on the product display page or a clearly marked hyperlink labeled “WARNING.” This is a departure from the current regulations, which do not expressly address Internet sales and provide only that a warning must be provided prior to exposure. For catalog sales, the warning must be provided in a manner that associates it with the product being sold. If an on-product warning is being provided, the same language may be used for the catalog warning.

Additional Warning Requirements for Alcohol, Furniture, and Other Products

The draft regulations delineate additional specific warning requirements for alcoholic beverages sold at retail stores; food and alcoholic beverages sold at restaurants; prescription drugs; emergency dental and medical care; other dental care; raw wood products; furniture products; diesel engines; vehicles; recreational vessels; enclosed parking facilities; amusement parks; petroleum products; service station and vehicle repair facilities; and designated smoking areas.