There are approximately three months until the effective date of the California Office of Environmental Health Hazard Assessment (OEHHA) revisions to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations. By August 30, 2018, companies must comply with the revised regulations for consumer products, occupational, and environmental exposures. Companies that have not already revised warnings to comply with the new requirements must now review their consumer products, occupational exposures, and environmental exposure scenarios in light of OEHHA’s revised policies and warnings to ensure compliance with the new requirements.
Under California Health and Safety Code Section 25249.7, penalties for violating Prop 65 warning requirements may be assessed in the amount of $2,500 per day, per violation. California’s Attorney General (AG) Office, as well as individual plaintiffs “acting in the public interest,” enforce Prop 65. Enforcement of these new regulations through California’s AG Office, or more likely private plaintiffs (i.e., bounty hunters), is expected to be immediate and potentially widespread. The focus by private parties on Prop 65 compliance is evidenced by the total amount of settlement payments that have risen in recent years. Between 2007 and 2017, total settlement payments, which include civil penalties and attorney fees, increased from $11.8 to $25.8 million. Interestingly, the average percentage of settlements that are paid as attorney fees has risen between 2007 and 2017 from 57 percent to 76 percent. Since the burden to demonstrate compliance quickly shifts to a company that receives a 60-Day Notice from a private enforcer regarding potential Prop 65 non-compliance, companies should carefully review the new requirements and ensure they have made appropriate changes to warning requirements when applicable or can otherwise support a decision that a warning is not required for a particular exposure scenario.
Information related to OEHHA’s past actions modifying Prop 65 warning regulations, including the August 28, 2016, adoption and the December 7, 2017, amendments, is available on our website, key phrase Proposition 65. A side-by-side comparison of the old and new regulations, updated to reflect the December 2017 amendments, is a helpful tool provided by OEHHA to demonstrate the extent of the changes. Some of the major changes that companies must consider are discussed below.
Consumer Product Exposure Warnings -- Content
The most obvious changes are those related to the required warning language. Cal. Code Regs. tit. 27, § 25603. These changes include:
- Adding a new warning symbol, consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline:
OEHHA’s website provides links to download several sizes of the warning symbols required to be included on most safe harbor warnings for exposures to listed chemicals under the new regulations.
Companies should note that the symbol can be printed in black and white if the sign, label, or shelf tag for the product is not printed using the color yellow, even if other colors are used.
- Changing the warning language to state that the product “can expose you” to the Prop 65 chemical.
- Referencing OEHHA’s new website, www.P65Warnings.ca.gov/product.
- Identifying the name of one or more of the listed chemicals for which the warning is being provided. When the warning is being provided for more than one endpoint (cancer and reproductive toxicity), the warning must include the name of one or more chemicals for each endpoint, unless the named chemical is listed as known to cause both cancer and reproductive toxicity and has been so identified in the warning.
Below is a comparison of the warning requirement for consumer products before the 2016 amendments and after:
Companies must review all the consumer products for which they provide warnings and determine how they will meet this new regulatory requirement on a product-by-product basis depending on whether there is one or more chemicals for which warning is required and the bases for each such warning.
Consumer Product Exposure Warnings -- Short-Form Warning
Section 25603(b) now provides a “short-form” on-product label as an acceptable alternative to the revised requirements for consumer product exposure warnings. OEHHA previously referred to this as the “on-product” warning but changed the term because the term “on-product” was confusing to some stakeholders to the extent it appeared to refer to a new warning method as opposed to a different warning content.
This option requires the hazard symbol, the word “warning” in capital letters and bold print -- WARNING, and a reference to OEHHA’s website, but importantly does not require a company to name a listed chemical within the text of the warning. With regard to the website reference and warning language, the short-form warning must contain one of the following: (1) for consumer products that cause exposure to listed carcinogen(s), the words “Cancer -- www.P65Warnings.ca.gov”; (2) for consumer products that cause exposure to listed reproductive toxicant(s), the words “Reproductive Harm -- www.P65Warnings.ca.gov”; or (3) for consumer products that cause exposure to both a listed carcinogen and a reproductive toxicant, the words “Cancer and Reproductive Toxicant -- www.P65Warnings.ca.gov.”
Under this option, 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 six-point type. Regarding the circumstances as to when it is permissible to use the short-form Prop 65 warning, and how that warning can be communicated, we note the following:
- Although OEHHA stated in its Initial Statement of Reasons that it believed the short-form warnings would be used more in cases when the full warning could not fit, OEHHA’s later guidance confirms that there is no limitation regarding the size of the package that can have a short-form warning.
- The prior reference to this as an “on-product” warning might have implied that the warning had to be printed on the product, however, OEHHA has clarified that printing the warning on the label or packaging is permissible.
Companies should consider whether this short-form warning language is a desirable option for some or all of their consumer products.
Consumer Product Exposure Warnings -- Foreign Language Requirements
Although OEHHA’s prior Prop 65 regulations contained no requirements with regard to providing warnings in languages other than English, the new regulations (Section 25602(d)) state the following with regard to consumer product exposure warnings:“Where a sign or label used to provide a warning includes consumer information about a product is provided in a language other than English, the warning must also be provided in that language in addition to English.” “Consumer information” is defined (Section 25600.1(c))to include warnings, directions for use, ingredient lists, and nutritional information and to exclude the brand name, product name, company name, location of manufacture, or product advertising. The revised regulations also set forth language requirements for environmental exposure warnings and for certain specific product, chemical, and area exposure warnings (e.g., food, amusement parks). A short-form warning also must be in any alternative language(s) used to provide consumer information on a label, sign, or shelf tag.
In response to comments expressing concern that these requirements as first proposed would require manufacturers to know what languages their retailers use to provide warnings, OEHHA clarified that the “alternative language warnings will be triggered based only on information provided for that particular product.” Final Statement of Reasons (FSOR) at 96. Thus, “where a product manufacturer or other business in the chain of commerce is not aware that a retail seller provides consumer information in other languages, the retail seller should be responsible for providing the warnings in those languages to the extent they are required.” FSOR at 213.
To the extent feasible, OEHHA plans to post approved translations for commonly used words on its website. OEHHA’s website now contains translations for examples of various Prop 65 warnings in nine languages other than English: Spanish, French, Chinese (simplified), Chinese (traditional), Hmong, Cambodian, Vietnamese, Tagalog, and Korean. It is unclear if or when OEHHA will provide additional translations, however.
With regard to the exact warning language and possible different translations, OEHHA states the following:
OEHHA agrees that there could be minor differences between various translations of Proposition 65 warnings. Rarely if ever is there only one correct way to translate a communication into another language. Even relatively simple translations require the translator to make decisions regarding word choices and restructuring translated sentences in ways that are clear to readers of the other language. It is not OEHHA’s intent to stipulate only one way to translate a warning or prevent translators from using their professional judgment. As long as the translation is reasonable and is sufficiently clear to the reader, it would comply with the requirements of the regulations. FSOR at 213.
Consumer Product Exposure Warnings -- Pesticides
On April 23, 2018, OEHHA announced it is proposing to amend Section 25603, specifically the safe harbor warning content to listed chemicals in pesticides. The proposal, if issued in final, would permit a warning for a consumer product exposure or occupational exposure from use of a pesticide to substitute the word “ATTENTION” or “NOTICE” in capital letters and bold type for the word “WARNING” in cases where the U.S. Environmental Protection Agency (EPA) and the California Department of Pesticide Regulation (CDPR) signal words and Prop 65 signal word conflict.
Consumer Product Exposure Warnings -- Method of Transmission
Companies also must review the methods of transmission they currently use for warnings and determine whether those methods are still valid and/or whether they wish to employ a new method of transmission. Section 25602.
While the revised regulations expand the list of acceptable methods for providing a warning via electronic means, the revised regulations also make clear that the warning must be provided to the purchaser “prior to or during the purchase of the consumer product, without requiring the purchaser to seek out the warning.” For Internet purchases, the warning must be provided to the purchaser prior to completing the purchase, which entails a warning separate from the warning that is provided on the consumer product.
Warning Responsibility: There are potentially complicated supply chains that can raise issues regarding who is responsible for providing a warning, and the amended regulations set forth new requirements if a business intends to comply with warning requirements by providing written notice to its retail seller. Section 25600.2. Generally, retail sellers are responsible for the placement and maintenance of warning materials, including warnings for products sold over the Internet, only when the manufacturer, producer, packager, importer, supplier, or distributor of a product provides written notice that:
- States that the product may result in an exposure to one or more listed chemicals.
- Includes the exact name or description of the product or specific identifying information for the product such as a Universal Product Code or other identifying designation.
- Includes all necessary warning materials such as labels, labeling, shelf signs or tags, and warning language for products sold on the Internet (i.e., no time-lag between receipt of the notice that a warning is required, and receipt of the warning materials themselves).
- Has been sent to the authorized agent for the retail seller, and the manufacturer, producer, packager, importer, supplier, or distributor has obtained confirmation electronically or in writing of receipt of the notice.
OEHHA provides requirements regarding the content and timing of such written notice, and also sets forth the specific circumstances when the primary responsibility for providing the consumer product warning is on the retail seller. Any company with an arrangement to have a retail seller or other entity provide a Prop 65 warning for its product(s) must review that arrangement and determine if current procedures comply with the revised regulations.
New Specific Product, Chemical, and Area Exposure Warnings: There are new regulations providing tailored methods for transmission of warnings and warning language for several products, chemicals, and area exposures. Sections 25607-25607.29.These are:
- Food (including dietary supplements);
- Alcoholic beverages;
- Food and non-alcoholic beverages in restaurants;
- Prescription drugs;
- Dental care and emergency medical care;
- Raw wood;
- Diesel engines;
- Passenger vehicles or off-road vehicles;
- Recreational vessels;
- Parking garages;
- Amusement parks;
- Petroleum products;
- Service stations and vehicle-repair facilities; and
- Designated smoking areas.
Any company that has warning obligations related to any of these scenarios must review and ensure compliance with the specific warning requirements.