Effective August 30, 2018, a new Proposition 65 “safe harbor” warning regime takes effect in California. Among other changes, the new regulations: (1) alter the responsibility between retailers and suppliers to provide warnings; and (2) revise the content and methods of transmission for “safe harbor” warnings (i.e., warnings deemed to comply with the law).

Proposition 65 is the Safe Drinking Water and Toxic Enforcement Act of 1986, California Health & Safety Code § 25249.5 et seq., and requires persons doing business in California to provide a “clear and reasonable warning” before causing an exposure to a chemical known to the state of California to cause cancer, birth defects or other reproductive harm. The new regime applies to products manufactured on or after August 30, 2018.

The new regulations specify warning content and methods of transmission for exposures from consumer products, generally, and from the following specifically: food, alcoholic beverages, food and beverages in restaurants, prescription drugs, dental care, wood dust from raw wood, furniture, diesel engines, vehicles, recreation vessels, enclosed parking facilities, amusement parks, petroleum products, service stations, designated smoking areas and hotels. Where an exposure occurs for one of these specific subgroups, then only compliance with the specific rules for the subgroup is deemed to be compliance with Proposition 65’s safe harbor warning.

Safe Harbor Warning Content. The most significant change to the new warning regime is the need to identify at least one chemical for each end point for which the warning is provided. There are four forms of safe harbor warnings for consumer products generally:

Option 1 – If the warning is provided for a chemical listed as a carcinogen:

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.

Option 2 – If the warning is provided for a chemical listed as a reproductive toxicant:

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 birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

Option 3 – If the warning is provided for a chemical listed as both a carcinogen and a reproductive toxicant:

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 and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

Option 4 – If the warning is provided for at least one chemical listed as a carcinogen and at least one chemical listed as a reproductive toxicant:

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, and [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

If a product bears a safe harbor warning, then the warning is deemed to cover all chemicals listed for the same endpoint(s). So, when warning option 1 is used, the warning covers exposures to all carcinogens associated with the product. The same holds true for option 2 with regard to reproductive toxicants. If exposures occur only to carcinogens, or only to reproductive toxicants, options 1 or 2 should be used. If warning option 3 (which warns for both cancer and reproductive toxicity) properly is used to warn for exposures to a chemical listed both as a carcinogen and a reproductive toxicant, then the warning covers all listed chemicals for which there is an exposure.

Option 4 provides a safe harbor warning that combines options 1 and 2. As for which chemicals to identify in the warning, regulators have written that the chemical should be one “for which a warning is being provided.” OEHHA has cautioned against “over warning” and some enforcers have stated an intent to prosecute for “over warning.” The legal viability of such a claim is an area of unsettled law. That said, most Proposition 65 lawsuits commence due to an alleged failure to warn.

Safe Harbor Warning Methods of Transmission. Safe harbor warnings for consumer products may be provided via:

  1. A product-specific warning provided on a posted sign, shelf tag, or shelf sign, for the consumer product at each point of display of the product.
  2. A product-specific warning provided via any electronic device or process that automatically provides the warning to the purchaser prior to or during the purchase of the consumer product, without requiring the purchaser to seek out the warning.
  3. A warning on the label.

If the consumer product warning is provided on the label then, in lieu of the “long form” warning language above, these short form warnings may be used (in at least 6-point font):

A. For exposures to listed carcinogens, the words, “Cancer - www.P65Warnings.ca.gov.”

B. For exposures to listed reproductive toxicants, the words, “Reproductive Harm - www.P65Warnings.ca.gov.”

C. For exposures to both listed carcinogens and reproductive toxicants, the words, “Cancer and Reproductive Harm - www.P65Warnings.ca.gov.”

Internet Warnings. For the first time, the new regulations require warnings for internet and catalogs sales even if the products already bear a warning. This results in “double warning,” but it is an element of the “safe harbor” regime. Warnings for internet sales must “be provided by including either the warning or a clearly marked hyperlink using the word ‘WARNING’ on the product display page, or by otherwise prominently displaying the warning to the purchaser prior to completing the purchase.” A warning in a catalog must be clearly associated with the item being purchased. There are additional details for these warnings.

Allocation of Responsibilities. The new regulations upend the traditional relationship between retailers and their suppliers by enabling suppliers to shift the warning obligation to retailers. To do this, an upstream supplier (e.g., an importer, manufacturer) must complete five steps: (1) provide notice to each retailer’s “authorized agent”; (2) precisely identify the product(s) that need a warning (e.g., by Universal Product Code); (3) state that the product(s) identified in the notice “may result in an exposure to one or more [Prop 65] listed chemicals”; (4) provide all necessary warning materials and/or warning text for products sold on the internet; and (5) confirm the retailer received the notice and update it. Most retailers, in turn, likely will resist being solely responsible for warnings. The regulations allow for contractual allocation of warning obligations, so long as the consumer receives any required Proposition 65 warning.  Now is a good time for all companies doing business in California to review their contracts, as well as their warnings, in light of the new regulations.