February 28, 2021

Volume XI, Number 59

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February 26, 2021

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California Proposes New Amendments to Proposition 65 Warning Regulations

California's Office of Environmental Health Hazard Assessment (OEHHA) has issued proposed amendments to limit the option for providing a shortened version of the Proposition 65 warning on consumer and other products. According to the agency, it is troubled by the widespread adoption of the short form warning by businesses. OEHHA is, therefore, proposing to limit the shortened warning to small packages, requiring the disclosure of the chemical name(s) in the warning, and prohibiting the use of shortened warnings for internet or catalog sales. The changes are meant to make the short-form warning less appealing to businesses, further drive identification of Proposition 65-listed chemicals in the warning, and to dissuade businesses from over-warning. The proposal was issued on January 8, 2021. Comments to the agency are due March 8, 2021.

Background

The current Article 6 regulations, which were adopted in 2016 and became effective in 2018, provide safe harbor warning methods and content options, including provisions for a so-called "short-form" warning. The short form warning permits identification of the general risk (cancer or reproductive toxicity) and a link to a state administered web site where additional information may be available. Unlike the standard Article 6 warning, the short-form warning is not required to identify the name of the chemical(s) that formed the basis of the warning when labeling the product, itself, or its immediate container, box, or wrapping. The short-form option is currently permitted for use without regard to package size or available labeling space.

As described in OEHHA's Initial Statement of Reasons (ISOR) for the January 8 proposed rule, the Agency is concerned with the widespread use of short-form warnings by businesses. OEHHA has previously stated publicly that it did not anticipate the short-form warning to be widely adopted because its brevity was expected to be unappealing to businesses. In the ISOR, OEHHA discloses that it sent 17 letters during 2019- 2020 to businesses providing short-form warnings, requesting additional information on the basis for the warning. Some companies provided limited information, while others failed to respond. Most did not identify an exposure that likely needed a warning-suggesting to OEHHA that the short-form option is leading to over-warning (i.e., warnings without an underlying basis). For these and other reasons described in the ISOR, OEHHA is proposing to limit the availability of the short-form warning option.

Proposed Rule

The proposal, if it becomes effective as currently drafted, would limit the short-form warning option in the following ways:

  1. Only allow the short-form warning (a) on products with five square inches or less of "label space" (which is not defined) and (b) when the standard warning will not fit;

  2. Prohibit the short-form warning for internet and catalog sales (even if the short-form warning provided on the product itself follows the regulations);

  3. Require that the identity of at least one chemical per relevant toxicity endpoint be included in the short-form warning; and

  4. Include the words "Risk" and "Exposure" in the warning.

The existing minimum type size requirements under current Article 6 would not change.

While the current Article 6 regulations do not explicitly permit the short-form warning on food products, the short-form warning was confirmed to be permitted for this purpose by OEHHA during the 2016 rulemaking. The proposed regulations will explicitly permit the use of the short-form warning on food.

To illustrate the impact of the proposal, we note the following example of the currently permitted short-form warning for both the cancer and reproductive toxicity endpoints:

  WARNING: Cancer and Reproductive Harm - www.P65Warnings.ca.gov.

Under the proposed regulations, the new short-form warning would read as follows (using formaldehyde and toluene for purposes of illustration):

    WARNING: Cancer Risk from Formaldehyde and Reproductive Risk from Toluene Exposure - www.P65Warnings.ca.gov.

OEHHA is explicit that these changes are intended to greatly limit the use of the short-form warning on all but small packages.

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© 2020 Keller and Heckman LLPNational Law Review, Volume XI, Number 14
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About this Author

Mitzi Ng Clark, Food, Drug Law, Keller Heckman Law Firm
Partner

Mitzi Ng Clark practices in the area of food and drug law, with an emphasis on food packaging.

Ms. Clark advises domestic and international corporations on a wide range of regulatory issues, ranging from FDA premarket clearance requirements for food-contact materials and local and state regulations concerning plastics and chemicals, to good manufacturing issues and regulatory requirements for food, cosmetics, and animal feed.  Ms. Clark’s practice extends to the international arena, where she counsels clients on regulatory matters in jurisdictions such as Canada, the European Union...

202-434-4238
Natalie E. Rainer, Keller Heckman, US Regulatory Compliance Attorney, Environmental Torts Lawyer,
Associate

Natalie Rainer joined Keller and Heckman in 2007. She practices in the area of food and drug law.

Ms. Rainer advises corporate clients regarding regulatory compliance in North America, Latin America, Europe, and Asia. During graduate school, Ms. Rainer worked at the U.S. Department of Justice, Civil Division as an intern in the Environmental Torts Section. In this position she participated in the defense of the federal government in multi-million dollar environmental lawsuits and wrote a successful U.S. Court of Appeals brief defending the...

415-948-2821
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