CA Office of Environmental Health Hazard Assessment provides notice of changes to proposed regulation to repeal and replace new Prop 65 "clear and reasonable warnings" regulation
On March 25, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) provided a notice of changes to the proposed regulation to repeal and add a new Article 6 to Title 27 of the California Code of Regulations (CCR) related to Proposition 65 (Prop 65) "clear and reasonable warnings." Until a final rule is promulgated, companies need not change their Prop 65 warnings; however, the final rule could require companies to revisit their warning language to ensure that they receive the benefit of the "safe harbor" regulation.
As some of you will recall, the proposed regulation was originally the subject of a Notice of Proposed Rulemaking published on November 27, 2015, which initiated a public comment period.1 OEHHA received 45 written comments from the public during the comment period that ended on January 25, 2016. In addition, OEHHA heard comments at a January 13, 2016 public hearing on the proposed regulation.
By way of background, OEHHA maintains a list of chemicals known to the state of California to cause reproductive toxicity or cancer, and Prop 65 prohibits businesses from knowingly and intentionally exposing consumers to a listed chemical without first providing a "clear and reasonable warning" of that chemical's effects. Prop 65 also prohibits the discharge of listed chemicals into sources of drinking water.
Under current Article 6 to Title 27 of the CCR, the following "safe harbor" warnings are deemed to be clear and reasonable: "WARNING: This product contains a chemical known to the state of California to cause cancer" or "WARNING: This product contains a chemical known to the state of California to cause birth defects or other reproductive harm," depending on whether the chemical is listed as a carcinogen or a reproductive toxicant. However, OEHHA feels that the existing "safe harbor" warnings lack the specificity necessary to ensure that the public receives useful information about potential exposures.
In addition to changing the proposed "safe harbor" warnings, the proposed regulation attempts to clarify the relative responsibilities of manufacturers and others in the chain of distribution for providing warnings for products that are eventually sold at retail.
OEHHA made over 60 substantive modifications to the text of the proposed rule, a full list of which is available in the notice of changes. OEHHA also released a tracked changes version of the regulation with the modified language. However, here are a few highlights of the modifications:
- Under the proposed rule, a warning would meet the requirements of Article 6 if it includes, among other things, the word "WARNING" in all capital letters and bold print, and:
- For exposures to listed carcinogens, the words, "This product can expose you to chemicals such as [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/product."
- For exposures to listed reproductive toxicants, the words, "This product can expose you to chemicals such as [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/product."
- For exposures to both listed carcinogens and reproductive toxicants (i.e., different chemicals), the words, "This product can expose you to chemicals such as [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/product."
- For exposures to a chemical that is listed as both a carcinogen and a reproductive toxicant, the words, "This product can expose you to chemicals such as [name of one or more chemical], 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/product."
- Section 25600(b) was modified to clarify that an Article 6-compliant warning that is provided before the two-year effective date will be deemed to be clear and reasonable.
- Section 25600(c) was revised to clarify that a person may request the adoption of a warning method or content for a "specific product, chemical or area exposure warning" rather than a specific consumer product.
- Section 25600.2(e)(2) [formerly numbered as (d)(2)] was modified to remove "and intentionally" and to add "knowingly" before "caused…" for alignment with the relevant statutory framework.
- Section 25602(b) was modified to clarify that for products sold on the Internet, the warning must be included on the product display page or provided as a clearly marked hyperlink on the product display page or otherwise displayed "prior to completing the purchase."
- The terms "consumer information" and "consumer product" were added as defined terms, and the phrase "producers, packagers, importers" was added to the definition of "authorized agent."
Any written comments concerning this updated proposed regulation must be received by OEHHA by 5:00 p.m. on April 11, 2016.
Until the proposed rule is finalized, companies need not take any steps to change their current Prop 65 warnings. However, once the rule is finalized, it will be important for companies to revisit their Prop 65 warning language and make any necessary changes should they choose to take advantage of the regulatory "safe harbor" provision.
If you have questions regarding the issues raised in this alert, or would like to submit comments to OEHHA, please contact one of the authors.
[1] A January 16, 2015 regulatory proposal to repeal and adopt Article 6 was withdrawn on November 27, 2015 to allow sufficient time for public comment regarding modifications to the proposed regulatory language. The November 27, 2015 proposal linked above replaced the January 16, 2015 proposed regulatory action, and took into account all comments received on the earlier proposal.