On Nov. 22, 2016, a Citizens’ Petition was presented to the Environmental Protection Abency (EPA) under Section 21 of the Toxic Substances Control Act (TSCA). The Petition requested EPA “to protect the public and susceptible subpopulations from the neurotoxic risks of fluoride by banning the addition of fluoridation chemicals to water,” excercizing its authority to prohibit the addition of fluoridation chemicals to U.S. water supplies on the grounds that a large body of animal, cellular, and human research indicate that fluoride is neurotoxic at doses within the range now seen in fluoridated communities. In 2017, after EPA denied the Citizen Petition, a suit was filed in federal court in San Francisco, as allowed under TSCA. The trial began Monday June 8, 2020, and was scheduled to conclude Friday June 19, 2020. For the first time in its 44-year history citizens reached the trial stage of a lawsuit under TSCA.
After final arguments concluded on Thursday June 18th, Judge Edward M. Chen (the Court) made a surprise proposal that he defer judgement, while EPA and the plaintiffs discuss a solution that will satisfy both.
The Court appeared convinced by the science indicating that fluoride poses an unacceptable neurotoxic risk to the 200 million in the U.S. (about 2/3s of the total population) who currently receive artificially fluoridated tap water, with the greatest risk to perinatal infants and children.
The best human evidence of neurotoxicity to date, is excellent. Two government-funded, well-designed, large, long-term, prospective cohort studies, ELEMENT (Mexico) and MIREC (Canada), published since the initial petition, were considered by the Court and, as the Court noted, strong science on fluoride neurotoxicity is accumulating all the time.
What is missing for EPA is a formal EPA-standard risk assessment of fluoride. However, although EPA has protocols for determining unacceptable risk of neurotoxins, and for determining a safe dose, if any, below which the risk is acceptable, EPA has not applied these protocols to fluoride. EPA began its evaluation of fluoride only well after the lawsuit was filed, and that evaluation is far from complete.
In addition, the Court determined that EPA has been applying the wrong standard to fluoride, looking for causation of harm, instead risk of harm. Risk alone is the standard mandated by statute, and any evaluation done under EPA’s current standard will be legally flawed.
The Court would like the plaintiffs to submit a new petition, including studies not yet published when the petition was filed, and perhaps to do, and submit, the formal EPA-standard risk assessment EPA says it requires, but has not yet done. The Court expects EPA to reverse course (like turning a battleship on a dime), accept the new petition and the new risk assessment, and do the right thing re. Fluoride. Attorneys for both sides expressed strong reservations.
EPA’s U.S. Justice Department attorney Debra Carfora explained that, by law, EPA must respond to a petition within 90 days, and that it takes a minimum of 3 years for EPA’s risk assessment process so, of course, EPA rejected the first petition, and would reject a second, no matter how excellent, for the same reason. A reevaluation of fluoride, this time focused on risk, would take several years at very least.
Michael Connett, lead attorney for the plaintiffs, explained that this is a citizens’ suit, that it has taken almost four years and considerable effort and expense (even though the legal team is working pro bono, and plaintiffs’ expert witnesses testified from “a sense of civic duty” – Philippe Grandjean, MD, PhD) to get to this point, and it might not be possible to do it all over again. Connett pointed out that, more important, in the meantime millions of U.S. babies and children suffer continuing harm.
In an additional nudge to plaintiffs, the Court mentioned that if the its verdict is appealed to a higher court, there is the possibility that the verdict could be thrown out, not on the evidence, but over the gray area of the standing of the plaintiffs to bring suit.
WHERE THE CASE STANDS NOW
The Court has asked the two sides talk to each other, and come back and talk with him in July, then have a formal conference with documents in August (Ms. Carfora said EPA needed at least two months). The Court will postpone ruling on the case, as long as necessary, until alternatives have been exhausted.
Fact Sheet o n the TSCA Trial
Daily Comments on the trial
Read more about the science, and access studies:
• The Mother-Offspring fluoride studies: http://fluoridealert.org/issues/tsca-fluoride-trial/the-mother-offspring-studies