On July 31, 2020, plaintiffs and the EPA filed a joint case management statement in the U.S. District Court for the Northern District of California seeking regulation under Section 6 of the Toxic Substances Control Act (TSCA) to prevent the addition of Ban fluoridation chemicals for drinking water supplies. Food & Water Watch, Inc. v EPA, Case No. 3: 17-cv-02162-EMC. As reported in our June 12 and June 22, 2020 blog articles, the court held a banking case that ended on June 17, 2020. After hearing the closing statements, Judge Chen asked plaintiffs and the EPA to consider how an agreement could be reached. According to the joint statement on case management, the parties met and deliberated to consider the EPA’s potential to discuss a new or amended petition so that, among other things, the EPA can “take into account the new science published after the original petition became”. Plaintiffs offered to file a new application with the EPA that included all of the evidence presented in the process, including the expert statements, expert statements and exhibits. The EPA claims that plaintiffs’ proposal to “package” the evidence presented in the lawsuit as a new petition under Section 21 of the Toxic Substances Control Act (TSCA) “would not be sufficient to create an unreasonable risk.” The EPA contends that “a meaningful review of a new petition based on the specific evidence base available to assess potential neurotoxic effects from exposure to fluoride from municipal water fluoridation programs” should include: (1) a systematic review; (2) raw data for the main studies on which the plaintiffs rely; and (3) the data underlying the plaintiffs’ risk calculations, including their benchmark dose analysis (BMD). The plaintiffs are willing to accept Dr. To provide Grandjean with the underlying data, however, can “not agree to the other two requirements”. The joint statement first states that plaintiffs claim they have already provided sufficient evidence to demonstrate undue risk under TSCA and are unwilling to conduct a new systematic review beyond what their experts already have have done. Second, plaintiffs allege that they are unable to provide the “raw data” for the key studies they rely on because the data is not their own and therefore the EPA is asking for something that plaintiffs are not can deliver. After all, plaintiffs do not believe the raw data is necessary for the EPA to evaluate the published peer-reviewed studies, and in fact, requiring this data is contrary to “TSCA’s health protection goals.”
On August 3, 2020, plaintiffs filed a further comment on the EPA’s position on a new petition. Plaintiffs state that they “are compelled to bring the court’s attention to the broader policy shift that EPA’s raw data demand represents and the overwhelming criticism these policies are receiving from virtually all public health and science sectors Has”. According to the plaintiffs, the EPA articulated this policy change in its Supplementary Notice on Proposed Rulebooks (SNPRM) of March 18, 2020 on “Strengthening Transparency in Regulatory Science”, in which “EPA proposed to reduce its dependence on peer Restrict or exclude reviews entirely ”. Study – no matter how relevant or well viewed – if the underlying raw data [are] Not made publicly available. “Plaintiffs cite a” detailed analysis signed by dozens of Harvard scholars, “which states that” the EPA’s new policy is ‘based on a deeply misguided view of how the scientific process works’ and ‘unnecessarily hampering EPA’s ability to base its internal analysis and regulatory decisions’ on the best available science.’ In addition, the rule ‘takes a partial and biased approach to transparency, systematically favoring industrial science over academic science.’ “
The EPA submitted a response on August 4, 2020, in which it described the plaintiffs’ further statement as “procedural and untrue”. According to the EPA, by publishing the raw data and explaining their statistical methods in detail, the authors of the studies could “remove mismatches and ensure that the scientific record is clear”. The EPA notes that it “takes the position that a meaningful, substantive review of the evolving scientific evidence published since the filing of its petition in 2016 should include raw data for the most important studies on which the Tribunal intended the plaintiffs rely, and according to Dr. Grandjean’s testimony is imminent. “The EPA affirms that its position” is based on the specific evidence base available for assessing potential neurotoxic effects from exposure to fluoride from municipal water fluoridation programs as necessary to support a potential TSCA regulation under Section 6 (a) “And not, as the plaintiffs claim, there is” broader political change “available.
The court held a status conference through Zoom on August 6, 2020. The judge suggested that the plaintiffs submit a new motion and that he keep the case open to make this possible. The next status hearing will take place 5th November 2020.
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