THE U.S. LAWSUIT AGAINST WATER FLUORIDATION
Food and Water Watch, et al.
Environmental Protection Agency
In the Fall of 2016, the Fluoride Action Network (FAN), under provisions in the Toxic Substances Control Act (TSCA), petitioned the U.S. Environmental Protection Agency (EPA) to prohibit the deliberate addition of fluoridating chemicals to the public drinking water, because they posed an unacceptable risk to the brain. Hard copies of approximately 300 animal and human studies were offered in support of this petition. In 2017, the EPA rejected the petition. FAN, along with several other groups and individuals, appealed this decision in Federal Court (the 9th District, located in San Francisco). The case was heard (via Zoom) in June 2020 over a period of two weeks, with Judge Edward Chen presiding.
Even though the weight of evidence on fluoride’s ability to harm the human brain was very convincing, FAN’s case was greatly bolstered in September 2017, when the first of several U.S. Government-funded mother-offspring studies was published (Bashash, 2017). This was the first major study that had examined exposure to fluoride during pregnancy (i.e. exposure at the fetal change). The results were very striking and could not have been more helpful to FAN’s case. Bashash found a strong relationship between the level of fluoride exposure to pregnant women (as measured in their urine) and a lowered IQ in their offspring. The studies were very rigorous (confounding variables were controlled for and all measurements were made at the individual level). Moreover, the mothers’ exposures were at levels commonly experienced in artificially fluoridated communities in Canada and the USA. FAN’s case was furthered bolstered by three other studies published before the trial began (Bashash, 2018; Green 2019 and Till 2020).
In the June trial, FAN was able to produce expert testimony of two of the key authors of the mother-child IQ studies (Bruce Lanphear (Green 2019 and Till 2020) and Howard Hu (Bashash, 2017). They also had expert testimony from two risk assessment specialists, Kathleen Thiessen, PhD, a member of the National Research Council that researched fluoride toxicity in 2006 (NRC 2006) and Philippe Grandjean, a key author of the Harvard meta-analysis of IQ studies published in 2012, and the lead author for the Benchmark Dose (BMD) analysis (subsequently published in 2021).
The big surprise was the that EPA chose not to use any of its own fluoride experts in defending their position but instead hired the company Exponent to do so. Exponent is renowned for defending a whole range of very toxic products and by-products for the chemical industry (Dow, Dupont, Monsanto etc.) which have included: dioxins, PCBs, glyphosate and PFAs.
Even though the Exponent lawyers did their best to muddy the waters by arguing that FAN had failed to perform a state of the art systematic review of the literature before declaring that fluoride was a neurotoxic hazard, even they had to conceded in cross-examination, that the National Institute of Environmental Health Science (NIEHS)-funded studies mentioned above, were the most important and rigorous studies conducted to date.
The Judge surprised those watching the case via zoom, when he interrupted the EPAs lawyer in her closing argument when she was trying to establish that fluoride was not a neurotoxic hazard. The judge opined that (1) fluoride was clearly a neurotoxic hazard citing, what both parties had agreed were the strongest studies conducted to date; and (2) argued that the EPA was demanding a standard of proof that even the best epidemiological studies cannot provide: namely, cause and effect.
To the plaintiff’s ears, this sounded like a victory, however the judge has postponed his final verdict until he has seen two more documents: the National Toxicology Program's (NTP) systematic review of Fluoride’s Neurotoxicity (requested by FAN in 2016) and a published version of the BMD analysis (risk assessment to determine a safe reference dose for fluoride based upon the pooled data in two of the mother-child studies (Bashash, 2017 and Green, 2019). The BMD analysis was published in June, but we are still waiting for the final report from the NTP. The judge has indicated that when the studies are in his hand (and possibly other mother-child studies being conducted), that he would probably entertain some more expert testimony from both sides on these published findings.
To date all attempts by the EPA to throw out the plaintiff’s case on the issue of standing have failed as well as the EPA's argument that FAN should refile their petition, because key evidence has been published since the original petition was filed in 2016. Throughout the proceedings, the judge made it clear that he is interested in what the best science has shown, rather than EPA's arcane arguments about what constitutes systematic reviews. Hence he insists on waiting for the NTP’s own review, before he makes his ruling. The National Toxicology Program (NTP) Review is expected before the end of this year and the final ruling possibly in early 2022.
DECEMBER 31, 2021
SEPTEMBER 19, 2022
The next status hearing for our federal TSCA lawsuit against the US Environmental Protection Agency (EPA) to end the use of fluoridation chemicals was originally scheduled for this upcoming Tuesday, September 20th, but has again been rescheduled by the Court. While I suspect that you are as frustrated as all of us here at the Fluoride Action Network (FAN) about the two year delay since our trial was held, we have some promising news.
First, the next hearing before the Court is now scheduled for Thursday, October 20th, 2022 at 1:30 p.m. (US Pacific) / 4:30 (US Eastern).
Second, the October hearing is expected to be more than a typical status update from both parties. For the past two years, the Court has been awaiting the final publication of the National Toxicology Program’s review on fluoride's neurotoxicity. This final publication was expected at the end of 2021, then promised again earlier this year, with May being the long-awaited release date. However, May came and went without any sign of the NTP report. For this reason, the Court continued to postpone our status hearings throughout the Summer.
In response to this indefinite postponement, last week FAN's attorneys filed a motion asking the Court to take the case out of abeyance and to restart it with an abbreviated second trial to review the latest scientific studies and NTP review. The NTP report is the culmination of years of research and work, and has already gone through at least three peer reviews. There is no longer a reasonable justification to wait for the powers-that-be to decide when, or if, it should be released to the public. We feel there is enough evidence available from the publicly available draft NTP reports and from other materials since the trial in June 2020 to complete the case and for the Court to render a decision. We’re confident the evidence is also strongly in our favor, including from the NTP’s review.
In short, we’ve patiently waited for the National Institutes of Health and the NTP to finalize this review of fluoride's neurotoxicity. We’re done waiting. It’s time for justice to be served, and we’re hoping that the October hearing will bring us closer to that end.
Thank you for your continued support,
Fluoride Action Network
OCTOBER 31, 2022
BIG NEWS! The Court ruled in favor of our motion, and the lawsuit against the Environmental Protection Agency (EPA) in federal court is moving forward, bringing us another step closer to a final ruling.
If you missed Wednesday's exciting hearing in federal court, you will be able to watch it. The court recorded the proceedings and will release it to the public. I was waiting to include a link to the recording in this bulletin, but it hasn't been released yet. When it is, the Fluoride Action Network (FAN) will immediately share it with you in an email and on social media. Stay tuned! In the meantime, here's what happened.
At the end of the initial trial in June of 2020, the Court put a stay/abeyance on the proceedings, wanting to wait for the National Toxicology Program (NTP) to finalize its review of the science on fluoride and human neurotoxicity. At the time, lawyers for the US Environmental Protection Agency (EPA) told the Court that the review would be forthcoming, and based on the NTP's typical review process, the delay on our trial ought to have been short-lived. However, in unprecedented fashion, the NTP has subjected their fluoride report to at least three separate peer-reviews, with a fourth currently ongoing. This is in contrast to previous NTP Monographs on other chemicals, where there has only been one public peer-review culminating in a public vote by a panel of scientists. More than two-years after the Court was assured a final document, the NTP has yet to publish one.
FAN and our attorneys felt that we had waited patiently for long enough. Prior to Wednesday's hearing, our attorneys filed a motion asking the Court to take the case out of abeyance and to hold a second trial where our experts can comment on the latest scientific studies, including existing versions of the NTP review. If the Court wasn't inclined to hold a second phase of the trial, we also expressed support for a ruling based on the existing record rather than continue waiting for the NTP.
The EPA objected to ending the stay, preferring the Court to either wait for the final NTP review or make a ruling based on the existing court record. The EPA were not in favor of reopening the trial to more expert testimony, new evidence, or any version of the NTP report but the "final" version, if one is ever published. That timeline would have likely delayed the trial into late 2023 or beyond.
On Wednesday, the Court ruled in favor of our motion to lift the stay on the proceedings. Not only did this signal the Court's desire to move forward with our case, but the Court specifically reopened discovery so attorneys and the Court could examine an updated version of the NTP's review, without it needing to be published. The EPA's objections to using any version of the NTP report besides the "final" version was based on their concern that the NTP's findings would be made public prematurely. To circumvent this objection, the Court placed the NTP's review under protective order so that it will only be available to the parties involved, the Court, and expert witnesses. The public will not have access unless the Court decides otherwise, or if FAN wins a separate pending legal case on our Freedom of Information Act Request (FOIA) for the report.
Thankfully, the Court made it clear to both parties that it expects to be provided with the NTP review before the next status hearing set for early January, regardless of what process is used to get it. The Court urged both parties to come together and find a way to get the current NTP review into the Court's hands "voluntarily," but our attorney, Michael Connett, was also told that if he needs the Court's help "using subpoenas or a motion to compel," he knows where to find the Judge. This was another victory for our side, as the Court clearly agreed with our argument that the updated NTP draft was worth looking at, and took action to obtain it.
In agreement with FAN's position, the Court reiterated its preference for a phase-two of the trial, with additional expert testimony. The Court also wants the NTP Director to explain in detail the remaining timeline for publishing their "final" review and the criteria for determining whether the review will be published or not.
Once the Court has the NTP review, the Judge will read it, as well as consider the NTP Director's responses to his questions. A determination will then be made whether to wait a little longer for the NTP to publish a "final" report, or admit the NTP draft as evidence, allowing us to immediately move the trial into the next phase.
We should find out at the next status hearing, scheduled for Tuesday, January 10, at 2:30PM (Pacific).
For more information about lawsuit, including a trial timeline and documents, click here.
For more information on the NTP's Review, click here.
Thank you for your continued support,
Fluoride Action Network
PS: Video of the Motion on October 26th now available (below).