The EPA appealed a U.S. district judge’s ruling which ordered the agency to set new rules on water fluoridation, alleging the judge overstepped legal statute when he allowed substantive new evidence to be presented during the trial.
In a landmark decision handed down Sept. 24, 2024, District Judge Edward Chen ruled that fluoridation at currently recommended levels of 0.7 milligrams per liter of water poses an “unreasonable risk” to children’s health.
The U.S. Environmental Protection Agency (EPA) had until July 18 to appeal the decision.
In the opening brief of its appeal, filed late Friday, the EPA didn’t challenge the merits of Chen’s ruling. Instead, the agency accused Chen of violating rules when he allowed evidence to be considered during the trial that was published after plaintiffs — Fluoride Action Network (FAN), Mothers Against Fluoridation and several individuals — petitioned the EPA in 2016 to change the water fluoridation regulations under the Toxic Substances Control Act (TSCA).
The EPA denied the petition, which led to the lawsuit, filed in 2017.
The lawsuit dragged out until late 2024, during which time research on the safety of water fluoridation continued, leading to new evidence of fluoride’s negative impact on health.
According to the EPA, that evidence — which included the 2024 National Toxicology Program’s (NTP) six-year systematic investigation into the effect of fluoride exposure on children’s neurodevelopment and several gold-standard scientific studies on large populations that showed fluoride’s negative impacts on children’s neurological development — likely should have been inadmissible during the trial.
FAN board member Rick North told The Defender the main takeaway from the brief is that the EPA “is not challenging the major point of the ruling: Fluoridation ‘poses an unreasonable risk of reduced IQ in children.’ The science behind fluoride’s neurotoxicity — at levels in fluoridated water — is rock-solid. And the EPA knows it.”
North added:
“Every day that EPA allows fluoridation to continue, more children are born with a higher risk of irreversible brain damage. This isn’t just a miscarriage of justice. It’s a perversion of public health.”
The EPA didn’t go so far as to say that none of the new evidence should have been considered during the trial. Instead, it said the court didn’t place sufficient limits on the amount of new evidence it considered.
The agency alleged that by allowing substantive new evidence into the trial proceedings, Chen turned the citizen’s petition in TSCA “into a license for judicial rulemaking.”
Michael Connett, attorney for the plaintiffs, told The Defender that the statute in question states that the judge is not limited to considering the administrative record available at the time of the petition, and that Chen ruled accordingly and allowed new evidence.
“The judge made very reasonable efforts to maximize judicial and agency resources efficiently, and the EPA is attempting to use that against him. We are dealing with real-world questions that have real-world effects on people’s health,” Connett said.
Connett added:
“A lot of new science came out after the initial petition was filed, and we presented that science and the judge ruled on it. The EPA now argues that the parties and the judge should have buried their collective heads in the sand and acted like this new science does not exist.”
Evidence against fluoridation continues to accumulate
Since the end of the trial, the body of scientific evidence showing fluoride’s adverse impacts on children’s health has continued to grow.
Scientists at the NTP in January published a meta-analysis in JAMA Pediatrics linking fluoridated water and IQ loss in children. In May 2024, a study in JAMA Open Network found children born to Los Angeles mothers exposed during pregnancy to fluoridated drinking water were more likely to have neurobehavioral problems.
Connett wrote on X that the EPA, its administrator Lee Zeldin, and U.S. Attorney General Pam Bondi “have the authority to withdraw this time-wasting appeal any time they choose. If they do, EPA would have the authority, under the court’s order, to implement a nationwide ban on fluoridation.”
Zeldin has repeatedly announced the EPA has concerns about water fluoridation and is doing another comprehensive review of the science on water fluoridation, but hasn’t commented on the appeal. Connett said another review is “not good enough.” “EPA needs to take *action,*” he wrote.
Both the EPA, which sets water fluoridation limits, and the U.S. Department of Health and Human Services, which makes recommendations on how much fluoride communities should add to drinking water, said they don’t comment on ongoing litigation.
In challenging plaintiff’s standing, EPA appears to concede recommended levels are unsafe
The EPA also argued in its brief that the plaintiffs lacked standing, or the legal right to sue.
The agency alleged that the only plaintiff who may have had standing — a woman who was pregnant and also hoped to have more children — lived in a place that had water with naturally occurring fluoride at levels between 0.24-0.4 milligrams per liter.
Even if the agency prohibited the further addition of fluoride to get the water supply to the currently recommended 0.7 milligrams per liter levels, she would still be exposed to the harm she seeks to avoid, EPA said.
The EPA’s argument about challenging her standing appears to concede that fluoride is harmful at levels even below the 0.7 milligrams per liter level at stake in the lawsuit.
The EPA’s brief opens with the statement “Fluoride is a common mineral that exists naturally in groundwater,” a statement often repeated by dental associations and the Centers for Disease Control and Prevention.
But the fluoride added to town water supplies is far from natural.
Naturally occurring fluoride is calcium fluoride. The fluoride added to water is the byproduct of phosphate fertilizer production, sold off by chemical companies to local water departments across the country.
The byproduct often comes in the form of hydrofluorosilicic acid, which is used by most large cities to fluoridate their water.
Three-judge panel will consider the appeal
The TSCA legislation authorizes the EPA to evaluate and regulate unreasonable risks posed by chemicals with which consumers come in contact. To do so, the EPA must do a risk evaluation to assess the hazard posed by a given chemical, and under what conditions it poses a risk.
TSCA has a clause that allows anyone to petition the EPA to do a risk assessment for a chemical. If the agency denies a petition, the people who filed it can sue in federal court.
The court then evaluates whether the chemical presents an unreasonable risk to health or the environment in a “de novo” proceeding, where it gives no deference to the agency. If the court finds a chemical poses an unreasonable risk, it can order the EPA to initiate the risk assessment.
The fluoride trial happened in two parts. After the first phase, in 2020, Chen put the proceedings on hold, given the emerging evidence relevant to the petition already at that phase of the lawsuit. Chen recommended that plaintiffs submit new evidence to the EPA in an amended petition — which they did — and that the EPA review it in a new administrative process.
However, the EPA told the court that such a process didn’t exist to reconsider its decision, and that the evidence would be insufficient for a new determination. The agency urged the court to make a decision at that time.
Chen instead put the trial on hold until the ongoing NTP investigation into fluoride safety was ready for publication. The NTP is an inter-agency U.S. government program that coordinates, evaluates and reports on toxicology research within public agencies.
Chen said that if EPA did want to resolve the issue administratively, he would wait to rule on the issue until the NTP report was published, so that he would have a complete record to rule on, EPA’s motion said.
The EPA now alleges that by doing this, Chen failed to act as a “neutral arbiter of the parties’ dispute.”
In the years that followed, officials inside the public health agencies attempted to undermine its publication, documents obtained through Freedom of Information Act requests showed. And even when the document was ready in draft form, the EPA continued to try to delay the trial.
Eventually, Chen ordered a draft version of NTP’s report to be made public so that the trial could continue.
The second phase of the trial began in January 2024. Over 10 days, the parties presented evidence from the draft NTP report released in 2022 and several new cohort studies — introduced by both sides — which had been published between 2019 and 2024.
In September 2024, Chen issued the historic decision in the lawsuit against the EPA, ruling that a preponderance of scientific evidence showed fluoride exposure at EPA allowable levels may damage human health, particularly that of pregnant mothers and young children.
He ordered the EPA to take regulatory action to address that risk.
The agency is appealing the decision to a three-judge panel in the 9th Circuit U.S. Court of Appeals. The appeals court will receive briefs from both sides, along with any amicus briefs, and hear oral arguments before issuing its decision.
If the 9th Circuit upholds the decision, the agency would be compelled to initiate rulemaking under TSCA, likely lowering allowable fluoride levels in drinking water.
Original article online at: https://childrenshealthdefense.org/defender/epa-appeals-landmark-ruling-fluoride-poses-unreasonable-risk-kids-health/