Fluoride Action Network

TSCA Trial

Under the Toxic Substances Control Act (TSCA) of 1976, a group of non-profits and individuals petitioned the U.S. Environmental Protection Agency in 2016 to end the addition of fluoridation chemicals into drinking water due to fluoride's neurotoxicity. The EPA rejected the petition. In response, the groups sued the EPA in Federal Court in 2017. A 7-day trial was held in June 2020 and the judge has yet to make his ruling as of December 2021.

LAWSUIT UPDATE

The June 14, 2022, status hearing for our case against the U.S. EPA in federal court has been rescheduled yet again,  to Tuesday, September 20th. 

The Court has been awaiting the final publication of the National Toxicology Program’s state of the science review on fluoride’s neurotoxicity before moving on to the next phase of the trial.  The NTP’s review was expected to be published in 2021, but continues to be delayed. See more at https://fluoridealert.org/researchers/the-national-toxicology-program/

We will provide additional information and updates as they become available.


Trial Hearing for June 14, 2022, cancelled.

The court is waiting on the NTP’s state of the science report on fluoride, which is still unavailable. The NTP inexplicably pulled its 4-5 year systematic review of fluoride’s neurotoxicity on February 9, 2021. At that time NTP said it would instead prepare a state-of-the-science review.


The status hearing for the TSCA trial on January 18, 2022,

The Federal Court in San Francisco held a status hearing for our lawsuit against the EPA. The hearing was brief, as the Judge reiterated his longstanding desire to wait until the National Toxicology Program (NTP) has published the final version of their review on fluoride’s neurotoxicity before continuing with the trial. The NTP communicated to the legal counsel for both parties that they had submitted the final draft of their review for external peer review, and the final report would likely be published around the end of March, but that this would be determined by the timeliness of the external review.

The Judge asked if a study from a Spanish birth cohort, which was only an abstract during the summer 2020 trial, had been published and peer-reviewed. The EPA reported that it had, and that its findings would help the EPA’s position. FAN’s counsel explained that there were serious problems with this study that expert testimony would spotlight at future hearings. Our counsel also made the Judge aware of the publication of additional studies strengthening FAN’s position, and the Judge responded that it would make sense to include these in the trial as well, so the EPA “has all of the information it needs to make a comprehensive assessment.”

The Court then set the next status hearing for June 7th at 2:30PM (Pacific Time). This ought to give the NTP enough time to publish their review. The Judge has suggested that once it has been published, FAN’s attorneys will be free to re-submit an amended petition to the EPA that includes the NTP publication and any additional neurotoxicity studies. The EPA will get a second chance to conduct an objective assessment following TSCA rules, which they didn’t do for the first petition. Once this has been completed, the Judge is expected to hold a second phase to the trial, giving experts an opportunity to assess the new evidence and the EPA’s response to our second petition if they choose not to deem fluoridation chemicals a hazard on their own.


Key dates and rulings so far:

Dec. 21, 2017
Court rules in plaintiffs’ favor, denying the EPA’s motion to dismiss the case. In denying the motion, the court noted, “The purpose of citizen petitions is to ensure the EPA does not overlook unreasonable risks to health or the environment.” The ruling is found here.

Feb. 7, 2018
Court rules in plaintiffs’ favor, denying the EPAs motion to limit review to the administrative record, thus allowing use of important new scientific studies published since the case was initiated. The ruling is found here.

Sept. 25, 2019
Court denies extension of time for discovery, which the plaintiffs opposed. The ruling is found here.

Dec. 30, 2019
Court denies both the plaintiffs’ and EPA’s motions for summary judgment, found here.

May 8, 2020
Court allows plaintiff’s expert witnesses Drs. Hu, Grandjean, and Lanphear, to participate in trial, rejecting challenge by EPA lawyers. Court says benefits of fluoridation are not to be part of trial, denying effort by EPA to include that topic.

June 8 – 19, 2020
A two-week trial by Zoom webinar. The trial had been originally scheduled to start in August 2019. It was then moved to April 2020 and further postponed to June 8 as a result of the coronavirus.

Up to December 2021
The Judge has not issued its ruling. After the trial ended in June 2020, the judge held several trial hearings with the attorneys. He informed them that he wanted two documents before making a ruling:

  1. The National Toxicology Program’s (NTP) systematic review of fluoride’s neurotoxicity. The NTP spent four years and millions of dollars to produce two draft systematic reviews on fluoride’s neurotoxicity. Both draft reviews stated,

    “NTP concludes that fluoride is presumed to be
    a cognitive neurodevelopmental hazard to humans.”

    On February 9, 2021, seven months after the trial ended, the NTP wrote a private statement, not released to the press or to the public, that it would not complete its systematic review. Instead, NTP wrote that it would do a “state of the science” report on fluoride’s neurotoxicity. The public learned of NTP’s private statement after lawyers representing the U.S. EPA in the TSCA trial submitted it into the record on February 22, 2021. This submission led to a February 24, 2021, article in InsideEPA which noted that this document would not include conclusions, thus it will have no “teeth” compared to a systematic review. The judge is waiting for this document. See Cowed by dental interests? by the Fluoride Action Network, April 19, 2021. Read more here.

  2. A Benchmark Dose analysis of fluoride’s neurotoxicity. This became available on June 8, 2021, with the publication of Grandjean et al.’s analysis, A Benchmark Dose Analysis for Maternal Pregnancy Urine-Fluoride and IQ in Children.

A timeline of the case can be found here.


Past Updates:

The September 14, 2021, status hearing with the Judge was cancelled. The next hearing will be held in January 2022. Details will be available closer to the date

June 10, 2021, Plaintiffs filed Notice to the court. They state,
“On August 10, 2020, the Court held this case in abeyance pending the publication of additional studies, including the National Toxicology Program’s systematic review of fluoride neurotoxicity and a pooled benchmark dose (BMD) analysis of the NIH-funded ELEMENT and MIREC cohorts. See ECF No. 262 at 4:19-26.
“On June 8, 2021, the pooled BMD analysis of the ELEMENT and MIREC data was published in the journal Risk Analysis, which is the official publication of the Society for Risk Analysis. The results of the peer-reviewed, pooled analysis are consistent with, and confirm, Dr. Philippe Grandjean’s earlier benchmark dose analysis that was discussed at trial and “can be used to guide decisions on preventing excess fluoride exposure in pregnant women.”

According to the study, which was authored by ten internationally esteemed scientists, including Dr. Grandjean:”These findings provide additional evidence that fluoride is a developmental neurotoxicant (i.e., causing adverse effects on brain development in early life). Given the ubiquity of fluoride exposure, the population impact of adverse effects from fluoride may be even greater than for other toxic elements like lead, mercury, and arsenic.”

April 22, 2021: TSCA Trial Hearing This Thursday

The next court status hearing for our TSCA lawsuit against the EPA over  fluoridation’s neurotoxicity is scheduled for Thursday, April 22 at 1:30pm (Pacific US). The focus will be on FAN’s motion to amend our petition to the EPA, which the Judge recommended before he placed the trial in abeyance. The amended version will have a more detailed list of plaintiffs, and will include recent studies that were part of the trial last summer.  While the hearing cannot legally be recorded, you can use the Zoom info below to watch the live proceedings.  FAN will also be providing updates on our Twitter page and in a future bulletin.


Refer to Timeline for submission of documents to the Court


January 2021:

Judge Chen informed the plaintiffs and the EPA on Dec 31 that he was canceling the Jan 7 meeting because he did not need any further oral testimony before he rules on the EPA’s motion to dismiss our case, which they have attempted before and lost.  He will issue his ruling on this motion based on the written arguments already submitted.

The Fluoride Action Network will let you and all supporters know when the judge issues his ruling on the EPA’s dismissal motion.


November 5, 2020:

A short meeting was convened by the Judge with lawyers representing both sides in attendance. Lead attorney Michael Connett told the Court that he filed, on November 4, a Supplement to our original Petition with the EPA. The Supplement asks that EPA reconsider their denial of our 2016 Petition. The reasons are set forth in the SUPPLEMENT and its 9 attachments. The Supplement has done everything the Court asked us to do with a new Petition. The Supplement also responds to the issue of Standing by identifying nine members of Food & Water Watch “who are currently pregnant, women who are actively seeking to become pregnant, and/or mothers of infants…”

The Supplement is a highly readable document and we urge our supporters to read it in full. However, if time is short we have presented excerpts at http://fluoridealert.org/content/bulletin_11-6-20/

THE DOCUMENTS

• THE SUPPLEMENT: Petitioners’ request to EPA to reconsider denial of their 2016 Petition.
Appendix A: Excerpt of Court’s August 10, 2020 Order.
Appendix B: Petitioners’ Summary of the Trial Record. Food & Water Watch, et al.
Appendix C: The NIH-funded Studies (Bashash, 2017, 2018; Till, 2018, 2020; Green, 2019).
Appendix D: National Toxicology Program’s Revised Monograph on Fluoride Neurotoxicity.
Appendix E: Dr. Linda Birnbaum’s Statement on the NTP Report.
Appendix F: Additional Details on the Limitations of the NTP Review.
Appendix G: Pooled BMD Analysis of the ELEMENT and MIREC Datasets.
Appendix H: Undisputed Material Facts from Trial and Court’s Ruling on Dental Benefits.
Appendix I: The Court’s Order Dismissing EPA’s Order to Dismiss.


• Watch this new interview about the trial between Robert F. Kennedy, Jr. and FAN attorney, Michael Connett, https://www.youtube.com/watch?v=E80yl_3fE-E


• October 12th article on trial: EPA hired consultants to counter staff experts on fluoride by Ariel Wittenberg, in E&E News


June 17, 2020:

The landmark federal trial pitting FAN and others against the US EPA over water fluoridation came to a dramatic turning point Wednesday, June 17.  FAN has argued that fluoride’s ability to impact the development of both the fetal and infant brain posed an unacceptable risk to millions of Americans (and others) drinking fluoridated public water supplies. The dramatic moment came when, after both sides had completed their summary statements, the federal judge surprised everyone by recognizing the key plank in the plaintiffs’ case and undermining the key argument in the EPA’s case.

The judge said:

So much has changed since the petition was filed…two significant series of studies – respective cohort studies – which everybody agrees is the best methodology. Everybody agrees that these were rigorous studies and everybody agrees that these studies would be part of the best available scientific evidence.

The EPA appears to have applied a standard of causation, which from my read of TSCA is not accurate. It’s not a proper allocation. It’s not the proper standard.

Closing Statements on June 17:

Here are just some of the powerful points from Michael Connett’s closing statement for the plaintiffs:

  • “In this case, the EPA has failed in its duties to protect the public from harm.”
  • “TSCA commands that the EPA not just protect the general public…if there is one unreasonable risk, to just one susceptible subpopulation, the EPA must take action to remove such risk.”
  • “We brought before your honor, world class experts of the highest order. Experts that the EPA has consistently depended on for assessments…The EPA has based their regulations on lead and mercury on our experts.”
  • “It’s undisputed that fluoride will pass through the placenta into the brain of the fetus. It’s undisputed that babies who are bottle fed with fluoridated water receive the highest doses of fluoride in our population at the moment of greatest vulnerability.  It’s undisputed that fluoride damages the brain.”
  • At the start of the trial I said there are three key questions that need to be answered. Is there a hazard? Is there a risk? Is the risk unreasonable? The answer [to all three questions] is a resounding yes.”
  • “We have 4 high quality cohort studies. Each has found associations between early life exposures to fluoride and lowered IQ…by around 5 IQ points. The effect size rivals the neurotoxic effects of lead.”
  • “There is no dispute that the developing brain is the most susceptible to neurotoxic side-effects.”
  • “The most likely explanation for the observed adverse effects…is that fluoride is a neurotoxin at the levels found in fluoridated communities across the United States.”

Michael Connett also pointed out that the experts the EPA relied upon, including the two Exponent employees, were not experts on fluoride, and that the agency did not call their own employees to answer key questions in the case.  He was referring to EPA’s foremost expert on fluoride, Dr. Joyce Donohue, as well as Dr. Kris Thayer.  Additionally, he said the EPA never once attempted to determine an estimate of what the levels are that cause neurotoxic effects. Connett added that the EPA witness Dr. Donohue said the National Institutes of Health funded-studies on which the plaintiffs relied were “well conducted” and “warrant a reassessment of all existing” fluoride standards.

Then Connett concluded his statement by showing the true extent of potential damage, saying we have 2 million pregnant mothers in fluoridated areas and over 400,000 exclusively formula-fed babies in fluoridated areas, all presently being exposed to fluoride-contaminated drinking water.

EPA’s Closing Statement:

The EPA’s attorney started by questioning whether fluoride posed a hazard.  Early on in her closing statement, the judge stopped her—which became a very common occurrence–and said, “The way you’re framing this is not helpful. I don’t think anyone disputes that fluoride is a hazard…the critical question is at what level it poses a risk.”

It was at this point, that the EPA’s closing statement turned into a 40-minute inquisition by the judge.  First he started asking about the EPA’s claims that the animal studies showed fluoride to be safe.  This resulted in him getting their attorney to admit that if the studies found a moderate effect in adult rats, then why wouldn’t there then be a prenatal and neonate effect?  This put the EPA in a corner, causing them to ditch their line of argument and admit that the human studies are in-fact more relevant.

The judge then reprimanded the EPA for challenging the reliability of Philippe Grandjean’s benchmark dose, but never taking the time to calculate their own to prove their point.  EPA quickly pivoted to an argument that the Canadian and Mexican cohorts weren’t applicable to the US; probably one of the most spurious arguments we hear from proponents.  The judge intimated that he was aware of the new study out of California proving otherwise, which appeared pretty devastating to the EPA.

The judge concluded by asking one final question, “Under TSCA, can the court find an unreasonable risk without finding causation?” EPA replied, “Yes.”

Judge Makes Recommendations:

After closing statements, Judge Chen immediately started sharing his views on the case and making recommendations.  This is when he said (it’s worth repeating):

So much has changed since the petition was filed…two significant series of studies – respective cohort studies – which everybody agrees is the best methodology. Everybody agrees that these were rigorous studies and everybody agrees that these studies would be part of the best available scientific evidence.

The EPA appears to have applied a standard of causation, which from my read of TSCA is not accurate. It’s not a proper allocation. It’s not the proper standard.

Chen continued by asking the parties whether they could discuss the possibility of an amended petition and re-assessment by the EPA, or start a new petition and have the EPA conduct a proper review, leaving his ultimate ruling until that was complete.

To many observers, it felt as though Chen was intimating that FAN had essentially won the case, but he was giving the EPA a chance to right their original wrongs.

Michael Connett pointed out that the EPA has dragged their feet for a long, long time (it has been 14 years since the NRC report recommended that the EPA determine a new maximum allowable level for fluoride in drinking water). Michael said plaintiffs were in a situation where the EPA has made a political decision not to do anything, which is why we brought this petition in the first place.  He also expressed concern that for a citizen’s group this is a massive undertaking, pointing out that the plaintiffs have spent 4 years building this case, and the concern is that the time and resources necessary to go through the process a second time would be prohibitive.

At this point, the EPA claimed that they couldn’t just re-evaluate our amended petition, because their guidelines for TSCA require an impossible burden of proof that no one could possibly meet to trigger a meaningful review.  They also claimed that the U.S. EPA does not have the resources or expertise to undertake a risk evaluation of fluoride neurotoxicity.

Judge Chen then made clear that a lack of resources is not an excuse, and said that if both parties can’t figure out a solution he’ll rule on it himself, as he’s been given the power to do so.

Connett then said that we can’t ignore the evidence we have in front of us, and the EPA needs to do something RIGHT NOW to warn people of this risk.


• Declarations from our 4 witnesses:

Philippe Grandjean, MD, PhD

Howard Hu, MD, MPH, ScD

Bruce Lanphear, MD, MPH

Kathleen Thiessen, PhD


August 6, 2020:

The ending of the trial was unexpected as the judge asked the two parties to work out an agreement. The judge suggested various scenarios (see his recommendations below) and he will hold a briefing with the two sides on August 6. This will be online and the public will be able to watch. We will post the zoom details online here closer to the time.


The drop-down menu at the top includes:

• Fact Sheet on the Lawsuit

• The Mother-Offspring Fluoride Studies

• Fluoride’s Neurotoxicity

• Lawsuit Documents

• Timeline of Events


See Newspaper articles on the court case


Videos on the TSCA Trial:

December 2020

December 2020

December 2020

December 2020

August 2020

August 2020

August 2020

August 2020

August 2020

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