Connett then turned to the question of the “data gap” or “uncertainty” that Barone and other EPA experts have argued is the basis for not requiring the agency to regulate fluoride.
Connett asked Barone if he agreed that uncertainty about the threshold level at which a chemical causes harm is not a basis for deciding not to do a risk assessment - the process that would likely lead to chemical regulation. Barone agreed but said the weight of the evidence was key. Connett also asked him if he personally agreed that the EPA should “use health protective assumptions” (i.e. an uncertainty factor of 10) when data is lacking. He said he did.
Chen intervened to ask Barone why the EPA couldn’t do its risk assessment
with the given information, using a “lowest observed effect level,” or LOEL. “I mean here we have a phenomenon where I think everybody agrees, as you put it, something’s going on,” Chen said, adding:
“And knowing that the EPA is to use health-protective assumptions when the information is lacking, why can’t one approach it from the low-level approach? We seem to know that there’s some level in which something’s going on. There’s adverse effects. We may debate where it is, but wouldn’t it be proper to use even a conservative estimate of LOEL?”
Barone insisted, as he did in earlier testimony, that the data are unclear. But he also conceded the EPA does often use the LOEL in risk assessment. Throughout Barone’s testimony, Connett drew concessions from Barone through “impeachment” — meaning Barone gave responses under cross-examination that contradicted statements he made in his earlier deposition. Connett read from Barone’s deposition testimony to demonstrate he was misrepresenting his responses.
To wrap up the trial and move forward with closing arguments, Judge Chen privately reviewed the recorded deposition of Jesús Ibarluzea, Ph.D., EPA’s final witness.
Dr. Ibarluzea is the author of the “Spanish study” that found fluoride increased IQ in boys by an implausible 15 points. 15 IQ points is enough to turn an average person into a genius, which no chemical has ever been found to do, calling the findings of his study into serious question.
Dr. Ibarluzea pulled out of testifying publicly in the trial after his study was scrutinized by plaintiffs for its ridiculously unbelievable findings.
At the close of the expert testimony, a scheduling change occurred. The Judge ordered that closing statements from both FAN and EPA now take place with a one-week delay, setting a February 20, 2024, closing date. The judge wanted time to watch deposition videos, look over evidence, and prepare a series of key questions for attorneys.
Closing Arguments
On February 20, 2024, rather than delivering summary closing arguments, attorneys for FAN and EPA responded for nearly three hours to the Judge’s detailed questions on technical aspects of the link between low-level fluoride exposure and lower IQ scores in children. The two sides also debated the role of uncertainty in risk assessment.
During the trial, top scientific experts who advised the EPA on understanding and setting hazard levels for other major environmental toxins and who conducted gold-standard “cohort” studies on the link between fluoride and low IQ in children testified for FAN.
They explained the NTP’s findings and presented evidence from their own research showing neurotoxic risks - particularly to pregnant women, formula-fed infants and children- posed by water fluoridation.
EPA witnesses conceded fluoride does have neurotoxic effects at relatively low levels but countered that the risk assessment process under TSCA is highly complex and there is too much uncertainty in the data on fluoride’s toxicity at current levels of water fluoridation to do a proper risk assessment and regulate the chemical.
It is now up to Judge Chen to decide if the EPA should be required to create a rule banning water fluoridation in the U.S. “Because the regulatory agencies have failed to do their job for decades,” plaintiffs’ attorney Michael Connett told Brenda Baletti of The Defender, “the court is now in the position of having to do it for them.”
“It’s not a job the court takes lightly,” he said. “It’s not a job the court wanted to do, but I think it’s a job the court is prepared to do.”
The Judgment
On September 24, 2024 the court ruled on behalf of the Fluoride Action Network and the plaintiffs. A U.S. federal court has now deemed fluoridation an “unreasonable risk” to the health of children, and the EPA will be forced to regulate it as such.
The decision is written very strongly in our favor.
Below is an excerpt from the introduction of the ruling:
"The issue before this Court is whether the Plaintiffs have established by a preponderance of the evidence that the fluoridation of drinking water at levels typical in the United States poses an unreasonable risk of injury to health of the public within the meaning of Amended TSCA.
For the reasons set forth below, the Court so finds. Specifically, the Court finds that fluoridation of water at 0.7 milligrams per liter (“mg/L”) – the level presently considered “optimal” in the United States – poses an unreasonable risk of reduced IQ in children.
The Court finds there is an unreasonable risk of such injury, a risk sufficient to require the EPA to engage with a regulatory response…One thing the EPA cannot do, however, in the face of this Court’s finding, is to ignore that risk.
Fluoride Trial Interview - Attorney Michael Connett
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