On March 25, 2016, the California Office of Environmental Health and Hazard Assessment (“OEHHA”) released a Notice of Modification to Text of the Proposed Repeal and Adoption of a New Article 6 Clear and Reasonable Warning Requirements (“Article 6”) (“March 25 Modifications”). The March 25 Modifications include: clarifying language regarding the means by which responsibility for providing a warning transfers from a manufacturer, producer, packager, importer, supplier or distributor to a retail seller, and modifications to the method and content of safe harbor warnings.
Article 6 of the Proposition 65 regulations (27 CCR § 25601 et seq.) sets forth “safe harbor” warning content and methods for exposures to listed substances. A business that employs the safe harbor warning content and method satisfies the requirements of Proposition 65. However, the regulations do not prohibit businesses from using other warning content or methods proven to satisfy the “clear and reasonable” requirements of Prop 65.
In January 2015, OEHHA proposed the repeal and re-adoption of a new Article 6 (“January 2015 Proposal”). In response to the proposal, OEHHA received 61 comments. According to OEHHA, due to the number of "substantive and clarifying changes" needed to address oral and written comments from the public, it decided not to proceed with the January 2015 Proposal, and repealed the proposal on November 24, 2015. On the same day, the agency issued a new notice proposing the Repeal and Replacement of Article 6 (“November 2015 Proposal”).
November 2015 Proposal
The November 2015 Proposal incorporated most elements from the January 2015 Proposal while also making numerous changes that: 1) clarified application of the new clear and reasonable warning requirements; 2) clarified responsibilities of manufacturers and retail sellers; 3) modified the methods of providing a warning that are deemed clear and reasonable; and 4) modified the content of the warning language that is deemed clear and reasonable. OEHHA received 45 comments from the public on the November 2015 Proposal, which are addressed by the March 25 Modifications.
Summary of the March 25 Modifications
The March 25 Modifications retain most of the clarifying changes proposed in November 2015, but also: 1) further clarify the means by which responsibility for providing a warning transfers from a manufacturer, producer, packager, importer, supplier or distributor to a retail seller; 2) significantly change the method and content of warnings that are deemed clear and reasonable; and 3) clarify what warnings would suffice during the phase-in period.
Allocation of Responsibility for Providing a Proposition 65 Warning to Consumers
The March 25 Modifications clarify and change the means by which responsibility for providing a warning can be transferred to a retail seller. Specifically, a responsible entity would be deemed to have satisfied its warning responsibilities where the responsible entity has directly provided the retail seller with notice that a warning is required and:
- The notice specifically states that a warning is required, includes the exact name or a description of the product for which the warning must be provided and includes or offers to provide all necessary warning materials, but may charge the retail seller for those materials;
- The responsible entity has obtained confirmation, either in writing or electronically, that the retail seller has received the notice;
- The responsible entity has provided the retail seller with notice, either electronically or in writing, within six months during the first year after the effective date of the regulation, and afterwards, annually; and
- The responsible entity has provided the retail seller with additional notice within 90 days when a different or additional chemical name or endpoint is included in the warning.
Upon receiving notice from the responsible entity, a retail seller would be responsible for placing and maintaining the warning materials, including warnings for products sold over the Internet, per the responsible entity’s instructions. The retail seller would also be required to ensure that the warnings are not obscured in any way.
The March 25 Modifications also clarify that responsible entities and retail sellers can allocate legal responsibility differently than is specified in the Article 6 regulations provided that the consumer receives a warning that meets the requirements of Proposition 65 “prior to exposure.”
Safe Harbor Methods and Content
The November 2015 Proposal included prescriptive safe harbor warning content and methods, which are softened in the March 25 Modifications. Specifically, the November 2015 Proposal included type size requirements which have been eliminated for all warning methods except for on-product labels, which must still be provided “in a type size no smaller than the largest type size used for other consumer information on the product” and no smaller than 6-point type. For all other signs and labeling used to provide a Proposition 65 warning, the proposed Article 6 would retain the current requirement that the warning be displayed “with such conspicuousness as compared with other words statements, designs or devices. . . as to render the warnings likely to be read and understood by an ordinary individual under customary conditions of purchase or use.”
Under the proposed March 25 Modifications, the following list of warning methods would be deemed to satisfy Proposition 65’s clear and reasonable warning requirements for exposures to listed substances in consumer products:
- 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;
- 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 information;
- For Internet purchases, a warning provided by “including either the warning on the product display page, or a clearly marked hyperlink using the word ‘WARNING’ or by otherwise prominently displaying the warning to the purchaser prior to completing the purchase;”
- For catalog purchases, a warning provided in the catalog in a manner that clearly associates it with the item being purchased;
- If an on-product warning is being provided for Internet or catalog purchases, the warning provided on the website or in the catalog may use the same content as the on-product warning; and
- If any label, labeling or sign provides consumer information for a product in a language or languages other than English, a warning must also be provided in the same languages on the label, labeling or sign.
The November 2015 Proposal required consumer product warnings to specify the listed substance for which the warning provided was required. The March 25 Modifications clarify that responsible entities need only specify one listed substance in a warning, even if the product may contain other listed substances. Further, the modifications would provide additional safe harbor language that could be used for exposures to a chemical that is listed as both a carcinogen and a reproductive toxicant. The following warning content would be deemed clear and reasonable, if the modifications are adopted as proposed:
- Inclusion of a warning symbol, described as an exclamation point in a triangle, which is no smaller than the height of the signal word “WARNING” and the background of which is either yellow or white;
- Inclusion of the word “WARNING” in all capital letters, and bold type face;
- Inclusion of a URL for OEHHA’s Proposition 65 website (the development of which is the subject of a separate rulemaking); and
- Use of the following language on packaging or signage:
- 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 listed carcinogens and to 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 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 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/product."
An on-product warning label would satisfy the regulation if it contained the following elements:
- The warning symbol described above;
- The word “WARNING” in all capital letters and bold type face; and
- Use of the following language:
- For consumer products that cause exposure to a listed carcinogen, the words, "Cancer - www.P65Warnings.ca.gov/product."
- For consumer products that cause exposures to a listed reproductive toxicant, the words, "Reproductive Harm - www.P65Warnings.ca.gov/product."
- For consumer products that cause exposures to both a listed carcinogen and reproductive toxicant, the words, “Cancer and Reproductive Harm - www.P65Warnings.ca.gov/product.”
The March 25 Modifications would also permit responsible entities to include supplemental information “to the extent that [the information] explains the source of the exposure or provide[s] information on how to avoid or reduce exposure to identified chemical or chemicals.” OEHHA is careful to include the requirement that the “supplemental information may not be substituted for the warning required by [Proposition 65].”
Implementation of Proposed Changes to Article 6
If adopted, the proposed changes would be effective two years after the date of adoption. During that interim or phase in period, use of warnings that satisfy the new regulations or that comply with the 2008 version of Article 6, which is currently in effect, would be deemed clear and reasonable.
Implications and Next Steps
Comments on the March 25 Modifications are due by April 18, 2016. After the close of the comment period, OEHHA will prepare its Final Statement of Reasons and will submit the final rulemaking package to the Office of Administrative Law for approval. Although there will be a two-year phase in period, businesses should prepare to modify the way they communicate Prop 65 warnings for consumer products once the regulations become final.