California’s Office of Environmental Health Hazard Assessment (“OEHHA”) recently finalized substantial amendments to the regulations governing the provision of warnings required by “Proposition 65” (a/k/a the “Safe Drinking Water and Toxic Enforcement Act of 1986”). Under Proposition 65, businesses who expose individuals in California to substances deemed by the state to cause cancer or reproductive harm must provide a “clear and reasonable” warning. The new revisions fundamentally alter the “safe harbor” provisions that prescribe the text and format for providing a warning that is deemed de facto “clear and reasonable.” The regulations provide specific warning instructions for a variety of exposure scenarios, including for consumer products, food and alcohol, public spaces, and more. Most notably, the new “safe harbor” warning regulations require the specific identification of at least one chemical for which a warning is required and allow for abbreviated on-product warnings for consumer goods. The new regulations also attempt to clarify liability among product manufacturers, retailers, and distributors.
The amendments mark the culmination of a multi-year process with the stated goals of making the ubiquitous warnings more meaningful to consumers; decreasing incidents of “over-warning” (where warnings are provided out of an abundance of caution); and providing compliance assistance on how and when to provide a warning. The amendments succeed, in part, by adopting more tailored warnings for specific products and places (such as for food establishments and parking garages), as well as by updating the regulations to address technological advancements, such as internet purchases.
By focusing exclusively on the question of how to provide “clear and reasonable” warnings, however, the amendments fail to address perhaps the most important question facing businesses confronted with Proposition 65 compliance: the issue of when warnings are required is not addressed at all. Hence, businesses will remain challenged by the paramount issue of whether a warning is required, particularly for a product that may contain a listed chemical but for which the company believes, based on its own due diligence and proper science, that exposure is below a safety threshold. (Remember, Proposition 65 requires a warning based on the potential for unsafe exposures to a listed chemical, not merely for the presence of the chemical in a product.) While a business rightfully should develop data on potential exposures to a listed chemical in a product, and assess the safety of that exposure, plaintiffs remain free to challenge such exposure/safety assessments and drag businesses into the expensive and time-consuming Proposition 65 enforcement process.
The new requirements undoubtedly will spawn a range of new issues to be addressed in litigation, including on issues such as the adequacy of existing warnings (arguably, the common warnings currently in place still meet the statutory criteria for an adequate “clear and reasonable” warning, but that concept likely will be tested in court); liability among retailers, manufacturers, and others in the supply chain; the sufficiency of “prophylactic” warnings provided without full assessment of potential exposure; and the legality of supplemental information provided to put a warning in proper context.
The major new provisions of the Proposition 65 warning regulations are summarized below. The final rule becomes fully effective on August 30, 2018; in the interim, both the old and the new safe harbor warnings may be used.
Safe Harbor Warnings for Consumer Products
The new safe harbor warnings for consumer products other than food must be preceded by a bold black-outlined yellow equilateral triangle with an exclamation point in the center (the “warning symbol”). There is no minimum font size when the safe harbor language is used. For internet purchases, the safe harbor warning must be provided by including either the warning or a clearly marked hyperlink using the word “WARNING” on the product display page, or by otherwise prominently displaying the warning to the purchaser prior to completing the purchase. If a consumer product sign, label, or shelf tag used to provide a warning provides consumer information in a language other than English, the warning must also be provided in the other language(s).
The new “safe harbor” warning language for consumer products is as follows:
- For exposure to carcinogens: “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.”
- For exposure to reproductive toxins: “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.”
- For exposure to both carcinogens and reproductive toxins: “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.”
The new system begs the question, in the case of products that may cause exposure to multiple listed chemicals, of how the business is to choose which chemical to identify if opting to identify only one as the rules allow. There is no requirement or guidance that directs the business to identify the most prevalent chemical or the one that may pose the greatest risk.
The “safe harbor” warnings also require a link to the new OEHHA “Lead Agency Website” established under a separate rule finalized earlier this year. The website is intended to provide information to the public about exposures to listed chemicals in different types of products. Under its new authority, OEHHA is authorized to require businesses to submit, upon request, a variety of information, including with respect to the chemicals for which a warning is being issued and the location and concentration of the chemicals. A company need not generate new information to respond to such a request, but would have to provide any information that they do have.
The new amendments limit the provision of supplemental information that attempts to contextualize the potential for exposure and risks. When provided “as part of the warning,” in order to qualify for the “safe harbor,” such supplemental information is limited to the source of exposure and ways to reduce potential exposures. This provision raises the issue as to what is considered “part of the warning” and where/how/what other kind of supplemental information may be provided.
On-Product Safe Harbor Language for Consumer Products
The new rule allows for abbreviated “on-product” warnings, which must be found on the product itself or on the immediate container, box, or wrapper.
- “WARNING: Cancer - www.P65Warnings.ca.gov.”
- “WARNING: Reproductive Harm - www.P65Warnings.ca.gov.”
- “WARNING: Cancer and Reproductive Harm- www.P65Warnings.ca.gov.”
A warning in written or electronic materials accompanying the product is not considered an on-product warning. All on-product warnings must contain the warning symbol and the regulatory language in a font size no smaller than the largest font size used for other consumer information (including warnings, directions for use, ingredient lists, and nutrition information) on the product and no smaller than 6-point font. An on-product warning for an internet purchase may use the same on-product warning language, but the purchaser must not have to search for it in the general content of the website. The requirement to provide warnings in any additional languages also applies.
Businesses should note that OEHHA may request information on the substance(s) giving rise to the warning and may publish that information on the Lead Agency Website. Therefore, despite the brevity of on-product warnings, OEHHA may inquire about the particulars of the chemical(s) at issue and may publicly post that information anyway.
Warnings on Food (Including Dietary Supplements)
Any Proposition 65 warnings on food, including dietary supplements, do not have to include the warning symbol, but must be set off from surrounding information and enclosed in a box. The safe harbor language is the same as listed above except that the word “Consuming” is inserted before the phrase “This product” at the start of the warning. On-product warnings are allowed for food product warnings, and the second language warning provision requirement also applies.
Warnings for Alcoholic Beverages
The warning for alcoholic beverages now includes a link to the Lead Agency Website, and reads: “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.” For an establishment serving alcohol, the warning can be provided with an 8½ by 11-inch sign placed at eye level in a location that is conspicuous to customers at each public entrance, or the warning can appear on a menu or list identifying the alcoholic beverages served. For a retail establishment, the warning can appear enclosed in a box in a notice or sign no smaller than 5 by 5 inches at each retail point of sale or display. The requirement to provide warnings in any additional languages applies here as well.
Specific "safe harbor" warning provisions are also established for the following products or exposure scenarios: Restaurants; Prescription drugs; Dental care and emergency medical care; Raw wood; Furniture; 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.
Clarification of Retailer and Manufacturer Responsibility
In response to a statutory mandate to minimize burdens on retailers, OEHHA has adopted new provisions governing liability among retailers, manufacturers, and others in the supply chain. The new provision provides manufacturers (and others in the supply chain, such as producer, packager, importer, supplier, or distributor) with two basic options: (1) affix an appropriate warning to the product; or (2) provide written notice to the retailer regarding the required warning for the product.
Under the second option, the written notice must be provided to the authorized agent for a retail seller in California and include: (1) a statement that the product may result in an exposure to one or more listed chemicals; (2) the exact name or description of the product or otherwise identify the product (such as by Universal Product Code); and (3) all necessary warning materials (labels, shelf signs, etc.) or language in the case of Internet sale. The manufacturer (or others in the supply chain) then must obtain confirmation of the retailer’s receipt electronically or in writing. The notice must be renewed within six months during the first year after the effective date and annually thereafter. If a retailer fails to post or obscures or alters a warning when the manufacturer has provided it, liability will fall on the retailer for failing to warn consumers.
Retailers have primary responsibility for providing a warning when they sell a product under a brand or trademark owned or licensed by the retailer or an affiliated entity, or if they add the listed chemical to the product. A retailer also is responsible 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 or otherwise has contacts with California.
In practice, of course, a third option always exists: whatever the retailer and manufacturer negotiate between themselves. This third option is likely to be a critical element of business practice for consumer products that contain Proposition 65 listed chemicals.
Kelley Drye has extensive experience providing counsel to consumer good and manufacturing clients on compliance with Proposition 65. We would be happy to assist your company in assessing your Proposition 65 obligations and developing an appropriate compliance program. For more information about this client advisory or Proposition 65 in general, please contact:
Joseph J. Green
Catherine M. Wilmarth