BPA and Proposition 65: Follow the Bouncing Ball
Talk about playing games! The California Environmental Protection Agency's Office of Environmental Health Hazard Assessment (OEHHA) proposes to list bisphenol A (BPA) as a chemical known to the State of California to cause reproductive toxicity in January of this year. The American Chemistry Council (ACC) files suit in March to prevent the listing from proceeding. Before the case can be heard, and just two weeks after the comment period on its proposal closes, OEHHA announces its decision to list BPA. Then, a week later, on April 19, 2013, the Sacramento County Superior Court issues a preliminary injunction ordering the listing to be removed pending a final resolution in the ACC lawsuit (American Chemistry Council v Office of Environmental Health Hazard Assessment, et al.). OEHHA immediately complies with the order, removing BPA from its list of reproductive toxins just eight days after first posting it. (To view OEHHA's notices concerning BPA and to access the preliminary injunction order, see OEHHA's website.)
The entire proceeding makes one wonder what OEHHA was up to—whether it is really interested in making decisions based on sound science, or if it just got caught up in the politics of BPA.
Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, requires the governor of California to publish, at least annually, a list of chemicals known to the State to cause cancer or reproductive toxicity. Among other things, the law prohibits the knowing exposure of any individual to a significant amount of a listed chemical without first providing a "clear and reasonable warning" to such individual. The law requires these warnings to be provided for consumer product, workplace, and environmental exposures unless "the person responsible can show that the exposure [to a listed carcinogen] poses no significant risk assuming lifetime exposure at the level in question," or, for a listed reproductive toxin, "will have no observable effect assuming exposure at 1,000 times the level in question."
Warning requirements go into effect for a designated chemical one year after the chemical is officially listed, and violations are subject to hefty civil penalties of up to $2,500 per day for each violation. Injunctive relief is also available. The law may be enforced by the California Attorney General, local district and city attorneys or, "bounty hunters"—private citizens permitted to bring enforcement actions if the state declines to do so or does not act within 60 days after it is notified of an alleged violation.
The proponents of Proposition 65 expected that the required warning would be perceived by industry as a deterrent to sales thereby encouraging product reformulations since consumers usually have a negative reaction when they see a warning on products they and their children use, including food, over-the-counter drugs, or personal care products—especially ones that warns against cancer or reproductive toxicity.
Somewhat ironically, it was this expectation that played to the strength of the ACC challenge to the listing.
OEHHA announced on January 25, 2013, that it intended to add BPA to the Proposition 65 list of reproductive toxicants under the authoritative bodies listing mechanism. In addition to announcing its intent to list BPA as a reproductive toxicant on January 25, OEHHA issued a separate notice proposing the adoption of a Proposition 65 maximum allowable dose level (MADL) of 290 micrograms per day for exposures to BPA. Exposures that are below the MADL "safe harbors" are exempt from the Proposition 65 warning requirements.
OEHHA's proposal to list BPA under the Proposition 65 authoritative bodies listing mechanism was based on a 2008 report issued by the National Toxicology Program's Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR). The report, titled, "NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A," cited several studies that found developmental effects in laboratory animals at high levels of exposure to BPA.
OEHHA's notice of intent included a table of the studies cited by NTP in concluding that "Bisphenol A had clear evidence for developmental toxicity at high levels of exposure." All of the studies listed involved BPA exposure to either mice or rats. Yet, NTP concluded in its report, "Overall, the current literature cannot yet be fully interpreted for biological or experimental consistency or for relevance to human health."
For whatever reason, OEHHA also didn't even mention, let alone consider, research conducted on BPA since 2008. One would think that a scientific agency would find that a worthwhile endeavor given that NTP pointed out in the report that, with respect to neurological and developmental outcomes of BPA, "additional research is needed to more fully assess the functional, long-term impacts of exposures to bisphenol A on the developing brain and behavior."
Even more interesting, the Developmental and Reproductive Toxicant Identification Committee (DART-IC) of OEHHA's Science Advisory Board voted unanimously in 2009 against the inclusion of BPA on the state's Proposition 65 list of reproductive toxicants finding that the experimental animal data cited in it were insufficient.
...And the Judge Calls Foul
ACC argued that it had a reasonable probability of prevailing on the merits because the NTP report did not identify BPA as causing reproductive toxicity. According to ACC, the report merely concluded that "the possibility that [BPA] may alter human development cannot be dismissed." ACC further pointed to several excerpts from the report to support its argument, noting NTP's use of terms such as, "insufficient evidence," "[n]egligible concern," "[m]inimal concern," and "[s]ome concern" in describing the myriad of effects that have been alleged.
ACC also provided the expert testimony from Dr. Anthony Scialli, who was involved in the NTP evaluation process, and who concluded outright, that the report "cannot be treated as a conclusion that BPA causes reproductive toxicity." The Doctor also pointed out the studies that have appeared since the report, which in his opinion, "taken with the other data in the [report], clearly establish that BPA is not toxic to reproduction using the criteria…of the regulations governing Proposition 65."
In response, OEHHA tried to argue that the NTP report was sufficient to identify a hazard, and that the NTP language involving level of concern only went to quantifying risk. To put it simply, the court was having none of it, and found four square on the point with ACC.
To obtain an injunction before trial, however, it was also necessary for ACC to demonstrate that its members would suffer irreparable harm should the listing remain in place. This, the plaintiff established, by pointing out that no government agency has ever found BPA to be a reproductive health concern, and that the California determination to do so would result in "widespread and irreversible consumer deselection of products made with BPA," which would have an irreparable impact on its members, others in the chemical industry, retailers, and consumers alike.
Although arguing that claims of deselection were nothing more than speculative on the part of ACC, OEHHA also argued that to grant the injunction would delay the provision of information to the public, which could be important to public health. Again finding for ACC, the court was quick to point out that OEHHA's argument about the delay in providing information to the public actually supported the ACC claim in that OEHHA's suggestion implies that when a consumer becomes aware of a listing, he or she will choose not to purchase such products.
Thus, it was the expectations of the effects that warnings would have on manufacturers, retailers, and consumers that moved the court to find justification to stay the OEHHA determination until it is satisfied that the evidence actually supports the listing—something that would appear for OEHHA to be a very tall order, indeed.