California’s Proposition 651 requires businesses to provide “clear and reasonable” warnings when they “expose” Californians to listed chemicals identified by the state to cause of cancer or reproductive harm (currently, over 800 chemicals are on the list). The California regulator that implements Proposition 65 has once again proposed far-reaching changes to the regulations that detail the specific requirements for Proposition 65 “clear and reasonable” warnings.

California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) started the process of repealing and replacing the warnings provision in 2014 (see our prior client alert here). The January 2015 first draft of the proposed changes met considerable pushback from businesses, which argued the new regulations went too far and were unclear, and consumer advocates, who argued the opposite.

On November 27, 2015, OEHHA formally withdrew its January proposal and released new draft regulations, addressing some criticisms and retaining some key controversial elements. The new proposal also provides better clarity on sell-through of products manufactured before the new law, and the validity of warnings previously approved in consent judgments.

The new regulations require more forceful warnings on consumer products that specifically identify at least one toxic chemical, and both food and consumer product warnings would need a hyperlink to OEHHA’s Proposition 65 website.

The new requirements likely will lead to increased activity by the Proposition 65 plaintiff’s bar as soon as the new regulations take effect. Consumer product and food companies should pay close attention to these proposed changes to avoid future targeting by plaintiffs’ lawsuits.

Key proposed changes to warning content

  • “Can expose”Consumer product warnings would need to state the product “can expose” the individual to a listed chemical, rather than that it “contains” the listed chemical, as currently required. Food product warnings would need to state “consuming this product can expose” the individual to a listed chemical. Over vigorous objection, OEHHA insists the word “contains” does not suffice to warn individuals they will be exposed to a chemical if they use a given product. 
  • Identification of chemicals: Under current regulations, a warning is “clear and reasonable” if it states that a product contains “a chemical” identified as a listed chemical. The January 2015 draft would have required warnings identification of each specific chemical among a list of 12 key chemicals (“the dirty dozen”) identified by OEHHA as commonly found in consumer products. The latest draft does not limit the identification requirement to the dirty dozen, but requires warnings to name the listed chemical for which the warning is being provided. 
  • Warning symbol: The new proposal retains the requirement that consumer product warnings contain the signal word “WARNING.” The latest proposal pushes one step further by requiring a warning symbol in all product warnings, except food warnings:
  • Hyperlinks: Almost all warnings after the effective date will require a hyperlink to a soon-to-be revamped OEHHA Proposition 65 website. There will be general “product” and “food” web pages, and also numerous specific websites, and thus specific hyperlinks required in warnings, for a range of product areas ranging from furniture, alcohol and diesel engines, to amusement parks and parking structures.
  • Additional languages: Existing regulations require only English warnings, but the new proposal would require warnings in non-English languages where product labeling contains information in alternative languages or at locations where signs are posted in those languages. 
  • Exceptions for on-product warnings: There are exceptions to some of the above requirements for on-product warnings, which do not need to list the chemical for which the warning is being provided. Businesses may use a truncated warning on product labels, using the symbol described above, the word "WARNING," and website reference noted above, but with only the words "Cancer," "Reproductive Harm," or "Cancer and Reproductive Harm," depending on the reason the chemical requires a warning. 

Good news for retailers 

Existing regulation on the relative responsibilities for providing warnings among businesses in the chain of commerce have created significant uncertainty. The new proposal clarifies the relative burden to warn between manufacturers and retailers and allows businesses to make agreements with retailers to allocate legal responsibility for the required warnings. The new Article 6 minimizes the burden on retail sellers and clarifies the placement of responsibility on manufacturers, distributors, and producers for providing warnings, and further limits and clarifies the circumstances under which a retailer will be required to create warnings. 

Sell-through 

The proposed regulations provide for a two-year effective date, meaning, if adopted, the new warnings would be required starting in 2018. Companies are free to update their warnings before the effective date of the new regulation

Importantly, if a warning is used pursuant to an existing court-approved consent judgment, it need not be changed for products covered under the judgment. Any warnings approved by a judge in a consent judgment before the effective date of the new rules would remain sufficient for the party or parties to the consent judgment.

The new regulations provide a sell-through period of unlimited duration for products manufactured prior to the effective date that comply with the previous version of the rule, saving businesses the burden and expense of relabeling or destroying existing inventories. In order to avoid unmerited Proposition 65 Notices after the regulations become effective, companies should keep detailed, verifiable, and readily-accessible records on dates of manufacture of products containing the old warning language. 

Looking ahead – note the timeline 

Food and consumer product companies that do businesses in California should assess the potential impact of the new regulations and develop an implementation strategy to retool warning protocols. Manufacturers and distributors of food and consumer products should be aware of the new rules allocating warning responsibility. Businesses dealing in products that display non-English languages should be mindful of the new foreign language label requirements.

Those interested in commenting on the revisions should note the following timeline: 

  • Public hearing – January 13, 2016
  • End of written comment period – January 22, 2016
  • Deadline for adoption of final amendment – November 2016