California Issues Final Rule on Proposition 65 -- Article 6: Clear and Reasonable Warnings
On September 2, 2016, California's Office of Environmental Health Hazard Assessment (OEHHA) issued a final rule amending Article 6 (Cal. Code Regs. Tit. 27, §§25600-25607.9) of the regulations implementing Proposition 65 (i.e., California's Safe Drinking Water and Toxic Enforcement Act of 1986). The final rule was promulgated after the issuance of several proposals, which were introduced starting in January 2015. The final rule imposes requirements on content and methods of transmission, including new Proposition 65 warning language that, in some cases, will require disclosing one or more Proposition 65-listed chemicals that resulted in the warning. The final rule clarifies, however, that an abbreviated warning, without naming any listed chemical(s), will be permitted when a company provides an "on product" warning for consumer products, which are defined to include food. This summary addresses key changes to warning requirements for consumer products, including specific requirements for food and alcoholic beverages.
The new warning requirements are effective on August 30, 2018, although either the old or new regulatory warnings may be used during the two-year transition period. Moreover, as under the current regulations, Article 6 sets forth "safe harbor" clear and reasonable warnings, but a business is free to use any other warning content or methods of transmission that could be considered clear and reasonable under Proposition 65 criteria (at the risk of challenge ).
Clear and Reasonable Warnings for Consumer Products
Currently, clear and reasonable warnings for consumer products under Proposition 65 are: "WARNING: This product contains a chemical known to the State of California to cause cancer" for carcinogens or "WARNING: This product contains a chemical known to the State of California to cause birth defects or reproductive harm" for reproductive toxicants. Under Section 25603(a), the new clear and reasonable warning requirement for consumer products other than food requires the warning to be preceded by a bold black-outlined, yellow equilateral triangle with an exclamation point in the center
(hereinafter "warning symbol"), followed by one of the following warnings:
When the product can cause exposure to a carcinogen:
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When the product can cause exposure to a carcinogen:
WARNING: This product can expose you to chemicals including [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.
When the product can cause exposure to a reproductive toxicant:
WARNING: This product can expose you to chemicals including [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.
When the product can cause exposure to both a carcinogen and a reproductive toxicant:
WARNING: This product can expose you to chemicals including [name of one or more listed 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.
When the product can cause exposure to a substance listed as both a carcinogen and a reproductive toxicant (e.g., lead):
WARNING: This product can expose you to chemicals including [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.
The link takes consumers to OEHHA's Lead Agency Website, a consumer-focused site launched in spring of 2016 that is designed to provide the public with additional information on listed chemicals. For more information, see here. There is no minimum font size when the standard warning is used.
Importantly, under Section 25603(b), abbreviated "on-product" warnings are permitted that would not require disclosure of one or more listed chemicals in the product. While the regulations do not define "on-product," OEHHA clarifies in the Final Statement of Reasons (FSOR) that "on-product refers to the product itself, as well as the immediate container, box, or wrapper of the product, but would not include other types of 'labeling,'"(defined under Section 25600.1 as "any written printed, graphic , or electronically provided communication that accompanies a product including tags at the point of sale or display of a product"). When providing an on-product warning, the same warning symbol is required, followed by one of the following warnings:
When the product can cause exposure to a carcinogen:
WARNING: Cancer -www.P65Warnings.ca.gov.
When the product can cause exposure to a reproductive toxicant:
WARNING: Reproductive Harm -www.P65Warnings.ca.gov.
When the product can cause exposure to both a carcinogen and a reproductive toxicant:
WARNING: Cancer and Reproductive Harm- www.P65Warnings.ca.gov.
Unlike the standard warnings, on-product warnings must appear in a type size no smaller than the largest type size used for other consumer information on the product and must be no smaller than 6-point font. "Consumer information" is defined to include warnings, directions for use, ingredient lists, and nutrition information and is defined to exclude the brand name, product name, company name, location of manufacture, or product advertising. If a consumer product sign, label, or shelf tag used to provide a warning includes consumer information in a language other than English, the warning must be provided in the other language(s) too.
We note that, under the Lead Agency Website regulations, OEHHA may request information from the manufacturer, producer, distributor, or importer of a product bearing a Proposition 65 warning on the identity of the chemical(s) giving rise to the warning, the location of the chemical in the product, the concentration (including mean, minimum, and mode) of the listed chemical in the final product, anticipated routes of exposure, estimated levels of exposure, and "any other related information concerning exposures to listed chemicals." OEHHA may then publish such details on its Lead Agency Website. Companies receiving such a request are not required to generate information they do not already have, but are required to provide the information they have within 90 days of the request. Thus, the Lead Agency Website provides OEHHA with an additional mechanism to obtain and publicize information on the specific substances giving rise to a warning.
For internet sales, the warning may be provided on the product display page, via hyperlink on the product display page to the word WARNING, or by otherwise prominently displaying the warning prior to purchase (e.g., by providing a pop-up warning as the consumer is proceeding with the purchase).
Given that food products do not generally include warning symbols, OEHHA does not require Proposition 65 warnings on food to include the warning symbol. But as an alternative method of drawing attention to the warning, Section 25603 requires the warning for food to be set off from other surrounding information and enclosed in a box. Also, the beginning of the standard warning is slightly modified; by way of example, the warning for carcinogens is as follows:
WARNING: Consuming this product can expose you to chemicals including [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.
Importantly, while not clear from the regulations, the FSOR confirms that the abbreviated on-product warnings permitted for consumer products may also be used for foods. And as with other consumer products, if a food sign, label or shelf tag used to provide a warning includes consumer information in a language other than English, the warning must be provided in the other language(s) too.
Clear and Reasonable Warnings for Alcoholic Beverages
The wording of the signage for the alcoholic beverage warning remains the same as before, except for the reference to the Lead Agency Website. The warning is:
WARNING: Drinking distilled spirits, beer, coolers, wine and other alcoholic beverages may increase cancer risk, and, during pregnancy, can cause birth defects. For more information, go to www.P65Warnings.ca.gov/alcohol.
The warning may be provided by an 8½ by
Obligations of Retailers
The new regulations replace Section 25603 ("Consumer Products Warnings") with Section 25600.2 ("Responsibility to Provide Product Warnings"), which details the mechanism by which a manufacturer, producer, packager, importer, supplier, or distributor can comply with Article 6 by providing written notice to the retail seller. While the statute requires OEHHA to minimize the burden on retail sellers of consumer products "to the extent practicable," the statute also does not mandate that warnings be provided on the label, and other methods of warning-including posting of notices, are permitted. Thus, OEHHA has determined that the provisions related to retailers' responsibilities are "a reasonable and consistent means of implementing the statute."
Section 25600.2 will permit a manufacturer, producer, packager, importer, supplier, or distributor to comply with Article 6 by either affixing a label to the product with an appropriate warning (as described above) or by sending the authorized agent for a retail seller in California a written notice that: (1) states the product at issue may result in an exposure to one or more listed chemicals, (2) identifies the product with specificity (e.g., by Universal Product Code), and (3) includes all necessary warning materials (or warning language, with respect to internet sales). The manufacturer, producer, packager, importer, supplier, or distributor must obtain confirmation of the retailers' receipt electronically or in writing, and the notice must be renewed within six months during the first year after the effective date (i.e., August 30, 2018), and then annually thereafter. If a retailer fails to post a warning when the manufacturer, producer, packager, importer, supplier, or distributor has provided the appropriate written notice, liability falls on the retailer for failure to warn under Section 25600.2(e)(4).
Section 25600.2(e) of the final regulations covers scenarios in which a retailer is primarily responsible for providing a warning, such as the sale of a product under a brand or trademark owned or licensed by the retailer or an affiliated entity. Also, a retailer is responsible for warning if it has "actual knowledge of consumer product exposure" and there is no manufacturer, producer, packager, importer, supplier, or distributor of the product who is subject to Proposition 65, and has designated an agent for service of process in California or has a place of business in California. "Actual knowledge" is defined as "specific knowledge of the consumer product exposure received by the retailer seller from any reliable source."
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The new regulations go into effect August 30, 2018, but a consumer product manufactured prior to the effective date is deemed to have provided a clear and reasonable warning, even after that date, if the warning complies with current version of Article 6. For more information, contact us a Prop65@khlaw.com or call Mitzi Ng Clark at (415) 948-2838.