Beginning May 11, 2016, California's Office of Environmental Health Hazard Assessment (OEHHA) will start requiring warnings for consumer products containing BPA under the Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65). BPA is an industrial chemical mainly used to make polycarbonate plastic and epoxy resins. It can be found in a variety of products, including bottled and canned foods and beverages, electrical and electronic equipment (e.g., mobile devices), automobiles, circuit boards, paints and adhesives. As the consumer product industry knows well by now, private litigants or “bounty hunters” in California will begin bringing lawsuits to enforce the new warning requirements starting from May 11, 2016. Companies making or marketing BPA-containing consumer products must be proactive in ensuring that they meet their legal obligations under Proposition 65 and develop strategies in responding to potential 60-day notices and threatened lawsuits.
This memorandum summarizes the key components of the Proposition 65 warning requirements as they relate to BPA.
Background: Proposition 65 Warning Requirements
By way of brief background, Proposition 65 requires the Governor of California to publish, at least annually, a list of chemicals known to the State to cause cancer or reproductive toxicity. Businesses are required to provide a "clear and reasonable" warning before knowingly and intentionally exposing anyone in California to a listed chemical.1 California officially listed BPA under Proposition 65 on May 11, 2015, as a developmental and reproductive toxicant.2 Proposition 65 provides a one-year grace period before companies must begin providing warnings for a newly listed chemical.3The compliance date for Proposition 65 warning statements for BPA-containing products is May 11, 2016.
Importantly, the mere presence of a listed chemical in a consumer product does not automatically trigger a legal obligation to warn. Under the “safe harbor” exemption, a Proposition 65 warning is not required if the company can establish that the level of the listed chemical in the product would result in an exposure level that is within a “safe harbor.” 4 Once California lists a chemical, manufacturers should first determine if the listed substance is present in any of their products. If it is present, the company should assess whether the substance is present at a level that is within a safe harbor established by OEHHA, or if no such safe harbor exists, within a safe harbor level that the company establishes. Any “safe harbor” established by a company must be developed using risk assessment methodologies that are scientifically sound.
OEHHA's Safe Harbor Levels for BPA
OEHHA has established safe harbor levels, in the form of No Significant Risk Levels (NSRLs) for cancer-causing chemicals and Maximum Allowable Dose Levels (MADLs) for chemicals causing reproductive toxicity, for many of the chemicals listed under Proposition 65.5 On March 17, 2016, OEHHA proposed to establish an MADL or safe harbor level of BPA of 3 micrograms (µg) per day for dermal exposure from solid materials.6 Businesses that manufacture or market consumer products that can expose California consumers to BPA through dermal exposure may want to determine whether the surface of these materials could present a BPA exposure that exceeds the 3 µg proposed safe harbor level. Such determination might involve theoretical modeling based on the BPA concentration on the surface of the consumer products. Companies may also engage third-party labs to conduct the so-called “wipe tests” to simulate consumer handling of the products.
As of today, OEHHA has not developed a “safe harbor” for oral BPA exposure because the issue is “technically complex.”7 OEHHA explains in the notice for the proposed dermal MADL that some of the federally funded studies on BPA will not be completed until 2017 or 2018, and the findings of these studies could form the basis of an oral MADL. These statements indicate that OEHHA may not propose an oral “safe harbor” for BPA until 2017 at the earliest and possibly in 2018 or even 2019. In the absence of an OEHHA oral “safe harbor” level, we encourage companies to work closely with their legal counsel to determine whether it is appropriate for a company to determine its own “safe harbor” level based on sound toxicology principles.8 A company that determines oral exposures from its products are within a “safe harbor” can take the view that its products are not subject to Proposition 65 warnings. A company that takes such a position on a product that has detectable levels of BPA in the food, however, does so with the risk that the state or the courts could interpret the “safe harbor” for BPA under Proposition 65 differently.
OEHHA's Emergency Regulation for Canned and Bottled Foods and Beverages
In a notice issued March 17, 2016,9 and in a subsequent notice issued on April 1, 2016,10 OEHHA proposed an emergency regulation to allow the temporary use of a standard point-of-sale warning message for BPA exposures from canned and bottled foods and beverages. Under the proposed regulation Section 25603.3(f), Proposition 65 warning requirements are deemed to be met if the “manufacturer, producer, packager, importer or distributor of the canned and bottled food or beverage either affixes a label to the product bearing a warning” or “[p]rovides written notice directly or through an authorized agent or trade association to the retailer or its authorized agent.”11 The written notice must include the following: (1) a statement that the canned or bottled food or beverage may result in an exposure to BPA; (2) the name or description of the canned or bottled food or beverages for which a warning is being provided; and (3) an offer to provide (or actually provide) a sufficient number of point-of-sale warning signs to the retailers.12 The proposed Section 25603.3(f) further provides that the “placement and maintenance of warning signs is the responsibility of the retailer seller of the affected products.”13
Under the proposed regulation Section 25603.3(g), the point-of-sale warning signs must be no smaller than 5 by 5 inches for products sold at a physical location. For products sold over the Internet, the warning must be provided either on the product display page or otherwise be prominently displayed to the purchaser. The Warning Sign shall contain the following:14
“WARNING. Many cans containing foods and beverages sold here have epoxy linings used to avoid microbial contamination and extend shelf life. Lids on jars and caps on bottles may also have epoxy linings. Some of these linings can leach small amounts of bisphenol A (BPA) into the food or beverage. BPA is a chemical known to the State of California to cause harm to the female reproductive system. For more information go to: www.P65Warnings.ca.gov/BPA.”
The emergency regulation will expire after 180 days. During this period, OEHHA plans to commence a regular rulemaking process to adopt the regulation as an interim measure for a one-year period from the date of adoption. OEHHA states that it believes the one-year period should be sufficient to ensure an orderly transition to provide warnings for BPA exposures, and for manufacturers to reduce or eliminate exposures to BPA by switching to safer alternatives where feasible. Companies can avoid putting warning labels on foods with detectable levels of BPA on an interim basis by utilizing the emergency warning provision. Any company that issues the written notice, however, presumably could be viewed as conceding their food “causes exposures to BPA” given the construct of the proposed regulation. Therefore, companies relying on the emergency regulation should explore with their legal counsel the impact of that decision on Proposition 65 warnings once the emergency regulation sunsets.
Bracing for BPA Proposition 65 Litigation
Proposition 65 permits private litigants or “bounty hunters” to bring private lawsuits to enforce the warning requirements. Violations of Proposition 65 are subject to civil penalties of up to $2,500 per day per violation.15 Courts in California generally interpret one “violation” for each product. The amount of penalties consequently can add up very quickly. Proposition 65 also allocates 25 percent of any assessed penalty to a successful plaintiff.16 Unsurprisingly, there are a number of plaintiff law firms specializing in Proposition 65 litigation in California.
A “bounty hunter” must notify the potential defendant and state prosecutors of the alleged violation and its intent to sue 60 days before a suit may be filed.17 On and after May 11, 2016, the date warnings will be required, we anticipate that many companies who sold consumer products into California will begin to receive 60-day notices for BPA.18 Given the existence of the emergency regulation, we suspect many retailers will post the warning about the possible presence of BPA in canned and bottled foods and beverages. If the retailers post the warning, the “bounty hunters” will be less likely to focus on BPA exposures from foods and beverages, at least initially. The same is not true for consumer products other than foods and beverages. In anticipation of BPA Proposition 65 litigation, it would be prudent to engage legal counsel early to determine whether a safe harbor level can be established for the product and to prepare to respond to potential 60-day notices and threatened lawsuits.