In May, an administrative panel unanimously voted to list Bisphenol A (BPA) as a hazardous chemical under California’s Safe Water and Toxic Enforcement Act, also known as "Prop 65". The scientific evidence cited by the panel has been controversial, and the basis for the panel’s decision is the subject of an appeal currently pending in California. For the time being, companies manufacturing, distributing, or selling products in California that contain BPA are required to provide a "clear and reasonable warning" of BPA’s hazards. Because of BPA’s prevalence in many of the most common plastic products — such as baby bottles, water bottles, food containers and many construction products — the new warning requirements threaten to impose a substantial burden on companies that manufacture and sell such products.1 Therefore an understanding of Prop 65, the debate surrounding BPA, and the consequences of BPA’s inclusion, is essential for companies engaged in the consumer or construction products businesses in California.

Background of Proposition 65 

Prop 65 was enacted in California because of mounting concern about exposure to toxic chemicals.2 Prop 65 provides (in the relevant part)

"No person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual…"3

Pursuant to Prop 65, each year the State of California publishes a list of chemicals that, "in the opinion of the state’s qualified experts, are clearly shown to cause cancer or reproductive toxicity".The original list, published in February 1987, contained approximately 30 chemicals.5 Since then, over 900 chemicals and chemical categories (e.g., "tobacco smoke" and "testosterone and its esters") have been added to the list of substances that are covered by Prop 65.

Most chemicals are added to the Prop 65 list via the State’s Qualified Experts (SQE) committees. Due to the public feedback loop inherent in the SQE process, the addition of new chemicals to the Prop 65 list often stirs controversy and debate among interested industry groups, scientists, and legislators. In practice, however, once a chemical is identified and referred to the SQE committee and receives the committee’s recommendation for inclusion on the Prop 65 list, it is likely to be added to the list.

Once a chemical is added to the list, companies have only 12 months to comply with Prop 65’s "clear and reasonable warning" requirement. The warning must "be reasonably calculated, considering the alternative methods available under the circumstances, to make the warning message available to the individual prior to exposure"and "the message must clearly communicate that the chemical in question is known to the state to cause cancer, or birth defects or other reproductive harm".7 These requirements can impose a substantial burden on any company that manufactures popular consumer products or building materials that contain a chemical on the Prop 65 list.

Although it is often a costly undertaking to adjust product labels to conform to Prop 65, the failure to do so can expose the company to even greater risk. Prop 65 can be enforced by state and county law enforcement officials, and plaintiffs’ lawyers are always on the lookout for products that contain a Prop 65 chemical without the necessary labeling. This is because Prop 65 allows any person to file a lawsuit "in the public interest," provided that they meet certain pre-filing notice requirements. A successful plaintiff can obtain a court order enjoining the defendant from further violating Prop 65, and a civil penalty of up to US$2,500 per day for each violation (in addition to any other applicable penalty).8 And, plaintiffs’ lawyers are often able to recover some portion of their attorneys’ fees as part of a settlement.9

The legal fight over BPA's inclusion in Prop 65 

In March 2013, while the decision to add BPA to the Prop 65 list was still uncertain, the American Chemistry Counsel (ACC) filed a complaint in the Sacramento County Superior Court seeking to block the Office of Environmental Health Hazard Assessment (OEHHA) from including BPA on the Prop 65 list. In its complaint, the ACC alleged, among other things, that the basis for the OEHHA’s decision directly conflicts with the SQE’s conclusion. The ACC sought and received a preliminary injunction enjoining OEHHA from listing BPA as a reproductive toxin pending the outcome of its suit. As a result, the OEHHA was forced to remove BPA from the Prop 65 list on April 19, 2013.

The ACC’s injunction was in effect until December 2014, when the Sacramento Superior Court issued an order denying the ACC’s petition and holding that the OEHHA "did not abuse its discretion in finding that theNational Toxicology Program (NTP) formally identified BPA as 'causing reproductive toxicity' within the meaning of the California definition" and reinstated the decision to list BPA under the State's Prop 65 law.10The court also denied the ACC’s request for stay pending appeal.

Having defeated the ACC’s challenge, the SQE issued new findings in May 2015 that "BPA was clearly shown through scientific and valid testing, according to generally accepted principles to cause reproductive toxicity based on the female reproductive endpoints," and the OEHHA officially added BPA to the Prop 65 list.11

"Safe Harbor" for products with BPA 

The OEHHA will next consider whether to establish a "safe harbor level" or maximum allowable dose level (MADL) for BPA, which would set the threshold level of BPA that would trigger Prop 65’s warning requirements.12 Although the MADL is subject to the OEHHA’s discretion, and the OEHHA can ultimately decide to set no MADL at all, the OEHHA is expected to set an MADL in this instance.13

If the OEHHA were to decline to set a MADL, it seems that the burden on industry would simply be too great, because manufacturers and sellers of any product that contains any amount of BPA would need to either provide the required warnings or affirmatively show that their product will not pose a significant risk of reproductive harm.14 The OEHHA has provided a potential clue regarding the MADL for BPA. In January 2013, before the ACC brought its claim, the OEHHA proposed a MADL of 290 micrograms per day, ostensibly to help industry and the public assess the impact of BPA’s potential listing (and probably to gauge the level of controversy that they were likely to provoke).15 The OEHHA is not expected to deviate substantially from this proposed MADL, but this is difficult to predict.

Comment 

The May 11, 2015 listing on Prop 65 started the clock on the one-year period for manufacturers, distributors, and retailers to implement "clear and reasonable" warnings that BPA is known to California to cause birth defects, or other reproductive harm.16 Unless and until the OEHHA establishes a "safe harbor" level, businesses that produce, distribute, or sell products in California that may expose the public to BPA should prepare to provide Prop 65 warnings for such products or face potential litigation and penalties when the grace period expires in May 2016.