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Volume XI, Number 25

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BPA Listing as Reproductive Toxicant Under Prop 65 Upheld by Court

The California Court of Appeal, Third Appellate District (Sacramento), has upheld the listing of bisphenol A (BPA) as a reproductive toxicant under Proposition 65 (Prop 65). Prop 65 a right-to-know law that requires individuals to receive a clear and reasonable warning before being exposed to certain chemicals that California deems to be carcinogens or reproductive toxicants.

By way of background, the National Toxicology Program – Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR) published a monograph in 2008, titled, “Monograph on the Potential Human Reproductive and Developmental Effects of [BPA].” The monograph, which primarily addressed studies in laboratory animals, stated that it is possible that BPA can affect human development or reproduction. Based on NTP-CERHR’s finding that BPA can affect human development or reproduction, the National Resources Defense Council (NRDC) petitioned California’s Office of Environmental Health Hazard Assessment (OEHHA) requesting that BPA be listed under Prop 65 as a chemical known to cause reproductive toxicity.

After reviewing the NTP-CERHR monograph, the Developmental and Reproductive Toxicant Identification Committee (DART-IC)—an OEHHA committee of qualified scientific experts—voted not to list BPA as a reproductive toxicant based on the state’s qualified experts listing mechanism in 2009. DART-IC members expressed skepticism as to whether the conclusions from the animal studies could be extrapolated to humans.

Although DART-IC decided to not list BPA as a reproductive toxicant, on January 24, 2013, OEHHA issued a notice of intent to add BPA to the list of chemicals known to the State of California to cause reproductive toxicity. In response, on March 1, 2013, the American Chemistry Council (ACC) filed a complaint in Sacramento County Superior Court seeking to enjoin OEHHA from adding BPA to the Prop 65 list. In its complaint, ACC stated that animal studies only provide limited evidence for developmental effects in human and that that OEHHA abused its discretion by refusing the 2009 DART-IC recommendation not to list BPA as a reproductive toxicant. On March 27, 2013, ACC also filed a motion for a preliminary injunction to enjoin OEHHA from listing or taking any further action in listing BPA with respect to Prop 65.

Despite ACC’s legal challenge, OEHHA published notice, effective April 11, 2013, stating that it was adding BPA to the list of chemicals known to the State of California to cause reproductive toxicity. However, in response to ACC’s March 1, 2013 complaint, the trial court granted ACC’s motion for a preliminary injunction, directing OEHHA to immediately remove BPA from the Prop 65 list. Therefore, BPA was delisted on April 19, 2013.

Eventually, the trial court denied the relief requested by ACC on March 27, 2013 and ACC appealed that decision. On October 19, 2020, the California Court of Appeal upheld the trial court’s decision to allow the listing of BPA as a reproductive toxicant under Prop 65. In the ruling (see American Chemistry Council v. Office of Environmental Health Hazard Assessment et al.), the Court of Appeal stated that adverse effects observed at high doses in animal studies are biologically plausible in humans.  The Court of Appeal added, “OEHHA did not abuse its discretion in listing BPA based on the monograph. Therefore, we conclude that the trial court did not abuse its discretion in denying ACC the relief requested in the amended complaint.”

In a separate action, not related to American Chemistry Council v. Office of Environmental Health Hazard Assessment et al., OEHHA listed BPA as a chemical known to cause female reproductive toxicity under the state’s Prop 65 qualified expert listing mechanism.  In the Agency’s May 11, 2015 notice announcing that BPA was being listed as a reproductive toxicant under Prop 65, OEHHA stated that, in 2015, DART-IC determined that BPA was clearly shown through scientifically valid testing according to generally accepted principles to cause reproductive toxicity based on the female reproductive endpoint. OEHHA claimed that a scientific review of BPA and reproductive health, published in the August 2014 issue of Environmental Health Perspectives, identified “substantial new epidemiological and toxicological data on female reproductive toxicity that have become available subsequent to the DART-IC’s consideration of BPA in 2009.” In a press release, ACC disagreed with DART-IC’s decision and stated, “The decision is not supported by the extensive scientific record presented to the committee and is completely contrary to explicit input provided by the U.S. Food and Drug Administration (FDA).”

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© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 329
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