OEHHA Proposes Revisions to Proposition 65 Short Form Warning Amendments
On December 13, 2021, the California Office of Environmental Health Hazard Assessment (OEHHA) published revisions to its earlier proposal in January 2021 to amend the Proposition 65 short form warning. Under the recent revisions to the proposed amendments, use of the short form warning for consumer products would be restricted to labels of specific sizes and would require the identification of the chemical(s) being warned for. If adopted, these short form safe harbor warning requirements will become effective one year after their formal approval by the Office of Administrative Law (OAL).
The deadline for public comments on the current proposal is January 14, 2022. OEHHA encourages the electronic submission of comments, which may be uploaded here.
Under Proposition 65, the State of California publishes and maintains a list of chemicals “known” to be carcinogens and reproductive toxicants. The law, passed by ballot initiative in 1986, prohibits businesses from knowingly and intentionally exposing an individual to these chemicals without first providing a clear and reasonable warning. The law is enforced exclusively by civil lawsuits; violators are subject to civil penalties of up to $2500 per day for each violation and may be enjoined by court order. In addition to public enforcers, private persons acting in the public interest may also sue to enforce Proposition 65. This citizen suit provision is the basis of the thousands of claims of alleged violations brought against companies every year.
In 1988, the Health & Welfare Agency (OEHHA’s predecessor agency) promulgated safe harbor warning regulations in order to provide guidance to businesses regarding the text and method of transmitting warnings that would be deemed “clear and reasonable” as a matter of law. Those regulations were amended in 2016, with an effective date of August 2018. Although safe harbor warnings are not mandatory, their use is strongly encouraged to avoid disputes about whether a warning meets the “clear and reasonable” standard.
The 2016 amendments established two alternatives for safe harbor warnings for consumer products: the long form warning (which requires the identification of the chemical(s) being warned for) and the short form warning (which does not). In promulgating these regulations, OEHHA specifically stated that the short form version of the warning could be used for any consumer product irrespective of label size.
Having realized that a significant number of businesses were using short form warnings, OEHHA proposed revisions in January 2021 fundamentally intended to discourage their use. A cynic might observe that OEHHA believes the short form warning is clear and reasonable if only a few businesses use it, but becomes unclear and unreasonable if many do.
OEHHA’s Revisions to the January Proposal
The table below summarizes the differences between the January and December proposals for consumer product short form warnings.
|Provision||January Proposal||December Revised Proposal|
|Limitation on when the short form warning may be used||(A) The total surface area of the product label available for consumer information is 5 square inches or less, and;
(B) the package shape or size cannot accommodate the long form warning, and;
(C) The entire warning must be in a type size no smaller than the largest type size used for other consumer information on the product. In no case shall the warning appear in a type size smaller than 6-point type.
|The total surface area of the product label available for consumer information is 12 (not 5) square inches or less.
The other two restrictions from the January proposal remain the same and are carried over in the December proposal.
|Online and catalog warnings||Online and catalog warnings must use the long form version of the warning even if the product carries the short form version of the warning.||If the product bears the short form warning, the online and catalog warnings also may use the short form.|
|Signal word (for warning text and for online warning hyperlinks)||Must say “WARNING”||Must say “WARNING” or “CA WARNING” or “CALIFORNIA WARNING”|
|Warning text for carcinogens||“Cancer Risk From [Name of listed carcinogen(s)] Exposure – www.P65Warnings.ca.gov”||“Cancer risk from exposure to [name of chemical] – www.P65Warnings.ca.gov.”
“Exposes you to [name of chemical], a carcinogen -www.P65Warnings.ca.gov.”
|Warning text for reproductive toxicants||“Risk of Reproductive Harm From [Name of listed reproductive toxicant(s)] Exposure – www.P65Warnings.ca.gov”||“Risk of reproductive harm from exposure to [name of chemical] – www.P65Warnings.ca.gov.”
“Exposes you to [name of chemical], a reproductive toxicant -www.P65Warnings.ca.gov.”
|Warning text for both carcinogens and reproductive toxicants||“Risk of Cancer From [Name of listed carcinogen(s)] And Reproductive Harm From [Name of listed reproductive toxicant(s)] Exposure – www.P65Warnings.ca.gov”||Cancer risk from [name of chemical] and of reproductive harm from exposure to [name of chemical] Exposure – www.P65Warnings.ca.gov.”
“Exposes you to [name of chemical], a carcinogen, and [name of chemical], a reproductive toxicant – www.P65Warnings.ca.gov.”
|Warning text for a chemical that is listed both as a carcinogen and a reproductive toxicant||“Risk of Cancer and Reproductive Harm From [Name of chemical(s) listed as carcinogen and reproductive toxicant] Exposure – www.P65Warnings.ca.gov”||“Cancer risk and reproductive harm from [name of chemical] exposure – www.P65Warnings.ca.gov.”
“Exposes you to [name of chemical], a carcinogen and reproductive toxicant – www.P65Warnings.ca.gov.”
Upon the close of the comment period, OEHHA will review submitted comments. OEHHA must finalize its proposal and submit it to the OAL by May 8, 2022 in order to avoid having to restart (or abandon) the entire rulemaking process. The regulations would become effective one year after the OAL’s approval. The final regulatory package to the OAL will include OEHHA’s responses to the comments received, which will be publicly available.
Considering the continued emphasis on limiting the use of the short form warning based on label size and requiring chemical identification, it seems likely that any final regulation will include those elements. Businesses will have to carefully evaluate their warning programs to ensure compliance if they seek to benefit from using safe harbor warnings. Such evaluation also should include reviewing (and, possibly, updating) communications with suppliers and customers regarding the text of warnings to be provided on product labels, websites and catalogs.
Businesses who will be adversely impacted by this proposal are strongly encouraged to submit comments, either on their own or through their trade associations, by the January 14, 2021 deadline.
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