Fluoride Action Network

The TSCA Fluoride Trial, 2016 – present

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 Court has yet to make its ruling as of December 2022.

The Timeline

November 22, 2016: On behalf of Fluoride Action Network (FAN), Food and Water Watch, MOMS Against Fluoridation, as well as several individuals, Paul Connett PhD and Bill Hirzy PhD served the EPA with a Petition calling on the Agency to ban the addition of fluoridation chemicals to public water supplies due to the risks these chemicals pose to the brain. The Petition was submitted under Section 21 of the Toxic Substances Control Act (TSCA) because it authorizes EPA to prohibit the “particular use” of a chemical that presents an unreasonable risk to the general public or susceptible subpopulations. TSCA also gives EPA the authority to prohibit drinking water additives. Below is the video of Connett & Hirzy bringing the Petition to EPA Headquarters in DC.

Above Video: The TSCA petition process begins


February 27, 2017: EPA denied the TSCA Section 21 Petition. Read their reasons here. In their decision the EPA claimed, “The petition has not set forth a scientifically defensible basis to conclude that any persons have suffered neurotoxic harm as a result of exposure to fluoride in the U.S. through the purposeful addition of fluoridation chemicals to drinking water or otherwise from fluoride exposure in the U.S.”

April 18, 2017: FAN et al.’s response to EPA’s rejection of Petition.

September 25, 2017: Motion to Dismiss FAN et al. Petition by the Department of Justice, on behalf of the EPA.

October 25, 2017: FAN et al. response to EPA’s rejection of Petition.

October 25, 2017: Amicus Curiae Brief of the Natural Resources Defense Council and Safer Chemicals, Healthy Families in Support of Neither Party. Their brief against EPA’s basis to dismiss our section 21 Petition focused on EPA’s unacceptable demand: “must evaluate all of a chemical’s conditions of use”

November 30, 2017: Hearing with arguments from both parties. Michael Connett, JD, put forward the arguments of why EPA’s Motion to Dismiss should be denied.

December 21, 2017: 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.

December 14, 2017:  The EPA requests court for “a protective order limiting review to the administrative record and an order striking Plaintiffs’ Jury Demand.”

January 5, 2018: FAN et al. submitted a brief in opposition to EPA’s motion to the court for a sweeping order that would exempt this “civil action” from Federal Rule of Civil Procedure 26(b) and deny Plaintiffs their right to discovery.

January 5, 2018: The National Resource Defense Council (NRDC) submitted an Amicus Curiae Brief in opposition to EPA’s motion to limit petitioner’s right to discovery. They state, “To the contrary, the language, structure, and history of section 21 all support the district court’s consideration of new evidence.” The NRDC involvement supports neither party on the merits of the case.

January 15, 2018: The U.S. EPA’s Reply “in Further Support of Motion to Limit Review to Administrative Record.”

January 18, 2018: The Defendant, EPA, “Answer” to FAN et al’s “Complaint of Fluoride’s harm submitted April 18, 2017. EPA’s response to each (107) paragraph in FAN et al’s “Complaint” of April 18, 2017, concluding: “Except as expressly admitted or otherwise stated herein, EPA denies each and every allegation in Plaintiff’s Complaint.”

February 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: Order Denying Defendant’s (EPA) Motion to Limit Review to the Administrative Record

Above Video: Court rules TSCA fluoride case can move forward

September 19, 2019: The Defendants’ Motion to enlarge time for limited expert discovery

September 23, 2019: The Plaintiffs’ oppose the Defendants’ Motion to extend time for discovery

September 25, 2019: The Court denies Defendants’ motion for extension of time

Above Video: TSCA case moves forward with discovery

October 9, 2019: Plaintiffs’ Notice of Motion & Motion for Summary Judgment and Partial Summary Judgment

October 9, 2019: Defendants’ Notice of Motion for Summary Judgment

October 18, 2019: Plaintiffs’ Opposition to Defendant’s Motion for Summary Judgment

October 18, 2019: Defendant’s  Opposition to Plaintiffs’ Motion for Summary Judgment and Partial Summary Judgment

October 24, 2019: Defendant’s Reply in Support of their Motion for Summary Judgment

October 24, 2019: Plaintiffs’ Opposition to Defendant’s Motion for Summary Judgment

December 19, 2019: Plaintiffs’ Proposed Findings of Fact

December 19, 2019: Defendant’s Joint Pretrial Conference Statement

December 20, 2019: Plaintiffs’ Trial Brief

December 30, 2019: The Court released its Order denying Plaintiffs’ and Defendant’s Motions for Summary Judgment. This means that our case will go forward. Trial is scheduled for two weeks beginning April 20, 2020 and will run for two weeks.

Above Video: Court rules TSCA fluoride case will go to trial

April 20, 2020: POSTPONED TSCA fluoride lawsuit trial dates, U.S. District Court, Northern District of California, San Francisco (postponed on 3/17/20 due to the coronavirus outbreak)

May 8, 2020: Pre-trial hearing. 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.

Pre-trial hearing. The Court cleared the way for three international experts in neurotoxicity to testify on the risks of fluoride in public water supplies. The court ruled that the purported benefits of community water fluoridation cannot be part of the trial, restricting testimony to the toxic risks under the Toxic Substances Control Act (TSCA)

May 2020: Declarations from our 4 witnesses:

Philippe Grandjean, MD, PhD

Howard Hu, MD, MPH, ScD

Bruce Lanphear, MD, MPH

Kathleen Thiessen, PhD


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.

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.


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.


December 31, 2020: 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.

April 22, 2021: Status Hearing. 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.


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.


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.


 

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