Fact Sheet on TSCA Lawsuit
Case Number: Civ. No. 17-CV-02162-EMC
A seven-day trail was held on June 8 through to June 19, 2020, in the U.S. District Court for the Northern District of California in San Francisco. Due to the coronavirus, the trial was broadcast live via video stream. Over 400 individuals watched the trial on a daily basis.
The Toxic Substances Control Act of 1976 (TSCA) authorizes the U.S. Environmental Protection Agency (EPA) to prohibit the “particular use” of a chemical that presents an unreasonable risk to the general public or susceptible subpopulations. TSCA gives EPA the authority to prohibit drinking water additives.
On Nov. 22, 2016, FAN, along with five other organizations and five individuals, presented a Citizens’ Petition under Section 21 of TSCA to the EPA. The Petition requested the EPA to exercise its authority to prohibit the purposeful addition of fluoridation chemicals to U.S. water supplies on the grounds that a large body of animal, cellular, and human research showed that fluoride was neurotoxic at doses within the range now seen in fluoridated communities.
The case landed in Federal Court after the EPA denied the Citizen Petition cited above as TSCA allows Plaintiffs to file suit. The Court denied EPA’s Motion to dismiss the case on December 21, 2017 – see the Court Order here.
For help in accessing court documents, the case number is Civ. No. 17-CV 02162-EMC. If you use the PACER (Public Access to Court Electronic Records) retrieval system online at pacer.gov, the number to type in 17-02162. You need to establish an account and login. There are some modest fees.
Groups: Fluoride Action Network, Food and Water Watch, Moms Against Fluoridation
Individuals: Audrey Adams, a resident of Renton, Washington (individually and on behalf of her son); Kristin Lavelle, a resident of Berkeley, California (individually and on behalf of her son); Brenda Staudenmaier, a resident of Green Bay, Wisconsin (individually and on behalf of her children).
U.S. Environmental Protection Agency (EPA)
This is the first time in its 44-year history that citizens have reached the trial stage of a lawsuit under TSCA. Paul Connett, PhD, executive director of FAN, stated the following:
“This case may be groundbreaking for environmental legal cases and, at least as important, it is groundbreaking for the opposition to fluoridation. Opposition to fluoridation is now at least 70 years old, but for most of that time has been wrongly dismissed as a fringe and unscientific position.
“The rapidly emerging science on developmental
neurotoxicity, especially loss of IQ from early life
exposure to fluoride, is a game-changer.
“It has brought the world’s leading environmental health
experts to not only engage in the science with the help
of millions of dollars in National Institutes of Health
funding, but also to conclude that the risk to children
is too great to consider water fluoridation safe.”
As stated in their initial Petition to the EPA under TSCA, the Plaintiffs want the EPA “to protect the public and susceptible subpopulations from the neurotoxic risks of fluoride by banning the addition of fluoridation chemicals to water.” EPA has the authority to regulate drinking water additives.
The Fluoride Action Network, Food and Water Watch, and Mothers Against Fluoridation present the court with a number of human, animal and cell studies supporting the assertion that fluoride is neurotoxic. These include “over 50 studies linking fluoride to cognitive deficits in humans,” according to the lawsuit complaint. Since the complaint, 15 more studies have been published, for a total of 65 studies reporting an association of fluoride exposure with lower IQ.
The complaint’s Statement of Facts says, “The National Research Council’s 2006 Review and Subsequent Peer-Reviewed Research Demonstrates Fluoride’s Ability to Harm the Brain.” It goes on to cite 50 human studies and 45 animal studies to support the claim. The complaint further states, “Fluoride Poses Neurotoxic Risks at Doses Comparable to the Doses Ingested in Fluoridated Communities in the United States.” The complaint includes extensive evidence to support the claim of neurotoxic risks from fluoridated water.
The complaint further states, “Susceptible Subpopulations Are at Heightened Risk of Fluoride Neurotoxicity.” “Nutritional status, age, genetics, co-exposure to other toxicants, and disease are known to influence an individual’s susceptibility to chronic fluoride toxicity,” according to the complaint. Infants, the elderly, those with poor nutrition, kidney disease sufferers, and African Americans are specifically identified as those with “heightened risk.”
Challenging the EPA’s own standards, the suit goes on to argue that, “The dose that would protect against fluoride neurotoxicity according to EPA’s Guidelines, and standard risk assessment procedures, is incompatible with the doses of fluoride ingested in fluoridated areas.”
The complaint also addresses the claimed dental benefits of fluoridation: “Recent Studies Show that Fluoridation Presents Little Meaningful Benefit to Teeth.” In support, the complaint cites a review of studies by the Cochrane Collaboration, a highly respected independent organization that critically reviews effectiveness of health treatments. The Cochrane review found a “high risk of bias” amongst the effectiveness studies and limited applicability to modern lifestyles. The review also noted that no Randomized Controlled Trials, the gold standard for health effectiveness evaluations, were found for fluoridation. The Plaintiffs’ complaint further asserts that “modern studies of fluoridation and tooth decay have found that the difference in cavity rates between fluoridated and non-fluoridated areas is small, inconsistent, and often non-existent, particularly in the permanent teeth.”
The lawsuit complaint concludes: “Fluoridation Is Unnecessary as There Are Safer, More Effective Alternatives, Including Topical Fluoride Products.” Citing a number of sources, including the U.S. Centers for Disease Control and Prevention, the complaint argues that “the major anticaries benefit of fluoride is topical and not systemic,” that quotation coming from a 2006 report of the National Research Council (page 16).
In bringing the lawsuit, FAN and co-plaintiffs justify the legal action by asserting that the EPA “dismissed studies relied upon by Plaintiffs on demonstrably false grounds” and “failed to consider the research on fluoride neurotoxicity through the framework of its Guidelines on Neurotoxicity Risk Assessment.”
PROGRESS OF THE CASE
A timeline of the case can be found here.
Several rulings in the case have gone in favor of the petitioners, allowing the case to proceed to trial:
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. Further details on the public’s access to the webinar will be announced prior to the trial. 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:
- The National Toxicology Program’s (NTP) systematic review of fluoride’s neurotoxicity. 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” document 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. The presumption is that powerful forces within the National Institutes of Health were behind the ending of the NTP’s systematic review and that they may be involved in the ‘state of the science’ report as well. Read more here.
- 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.
Lead attorney Michael Connett has stated:
“We have been fortunate to be able to work with some of the world’s leading experts on fluoride’s neurotoxicity, and these experts will be testifying at trial.”
See Connett’s video update on the case.
Plaintiffs’ Expert Witnesses (partial list)
Philippe Grandjean, MD, PhD
Dr. Grandjean is adjunct professor of environmental health at the Harvard School of Public Health. A Danish scientist, he works in environmental medicine and is the head of the Environmental Medicine Research Unit at the University of Southern Denmark. He has led groundbreaking investigations of neurotoxic chemicals, including mercury and fluoride. He is considered a leading expert in the field, having won numerous awards. (Curriculum vitae and Wikipedia)
Howard Hu, MD, MPH, ScD
Dr. Hu is a physician-scientist, board-certified in Internal Medicine and Preventive (Occupational) Medicine, who most recently served as Professor of Environmental Health, Epidemiology, Global Health and Medicine and the Founding Dean of the Dalla Lana School of Public Health at the University of Toronto (2012-2018) and is now at the University of Washington School of Public Health. Dr. Hu was the senior investigator on an NIH-funded (National Institutes of Health-funded) study examining the effects of prenatal fluoride exposure on IQ and other neurodevelopmental harm. (See Bio)
Bruce Lanphear, MD, MPH
Dr. Lanphear is a professor of health sciences at Simon Fraser University in British Columbia. Dr. Lanphear’s groundbreaking research on the neurotoxic effects of low-level lead exposure has shaped regulatory policy in the U.S., and he is now conducting similar (NIH-funded) research on the impacts of low-level fluoride exposure on IQ. Among his interests are early childhood health and environmental neurotoxins. (See Bio)
Kathleen Thiessen, PhD
Dr. Thiessen is a risk assessment scientist at Oak Ridge Center for Risk Analysis who served on the National Research Council panel that prepared the landmark 2006 review, “Fluoride in Drinking Water: A Scientific Review of EPA’s Standards.” Dr. Thiessen has authored health assessments on fluoride, and other toxic substances, for the EPA and other federal agencies. (See Bio)
Defendants’ Expert Witnesses (partial list)
Ellen Chang, ScD
Joyce Tsuji, PhD
Both of the above experts are employed by Exponent, Inc., a consulting firm known for servicing large corporations.
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