Judge: Fluoride in water poses unreasonable risk

In what could become a landmark decision, a federal judge has ruled that, by a preponderance of the evidence, the fluoridation of drinking water at levels typical in the United States poses an unreasonable risk of injury to public health.

As such, the federal Environmental Protection Agency (EPA) can no longer ignore that risk, judge Edward Chen of the U.S. District Court of the Northern District of California ruled Sept. 25.

“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,” Chen wrote in the decision. “It should be noted that this finding does not conclude with certainty that fluoridated water is injurious to public health; rather, as required …. , the Court finds there is an unreasonable risk of such injury, a risk sufficient to require the EPA to engage with a regulatory response.”

Chen said his order did not dictate what that response must be.

“One thing the EPA cannot do, however, in the face of this court’s finding, is to ignore that risk,” he wrote.

In the decision, Chen observed that water fluoridation has a long history in the United States and has been a source of political discord at times.

“However, scientific evidence has increasingly identified a link between fluoride exposure and adverse cognitive effects in children (reduced IQ),” he wrote. “Accordingly, plaintiffs exercised their power under the Amended TSCA (Toxic Substances Control Act) and petitioned the EPA to consider whether fluoride in drinking water presents an unreasonable risk of injury to human health.”

The EPA denied any association, Chen observed, “notwithstanding the growing and robust body of evidence indicating an association between fluoride intake and cognitive impairment in children.”

The decision marks a huge blow to the EPA, public health agencies, and the American Dental Association (ADA), all of which have long praised the benefits of water fluoridation. In 2015, the Centers for Disease Control (CDC) proclaimed community water fluoridation to be “one of the 10 greatest public health achievements of the 20th century.”

It was anything but, says Stuart Cooper, the executive directive of Fluoride Action Network (FAN), after the ruling. FAN was a principal in the lawsuit, as was Moms Against Fluoride and Food & Water Watch, along with individual parents and children.

“Communities are currently adding this neurotoxin to the public water supplies voluntarily,” Cooper wrote on the FAN website. “The harm is needlessly self-inflicted, but this also means the solution is simple: ban the use of fluoridation chemicals.”

Cooper said he expected an appeal of the decision or foot-dragging by the EPA in writing a new rule.

“In our view, attempts by the EPA to appeal or delay this ruling will only result in harm to hundreds of thousands of additional children, particularly those whose families are unable to afford expensive reverse osmosis or distillation filtration of their tap water,” he wrote.

But, Cooper said, policymakers at the local and state level do not need to wait to take action because the federal government doesn’t mandate fluoridation, and thus local and state decision makers can take action immediately. 

“The public didn’t sign up to have a chemical added to public drinking water that could adversely affect the brain,” he wrote. “And while a cavity can easily be filled, damage to the brain is permanent, and the consequences are lifelong. There are no second chances when it comes to impaired brain development.”

The decision

In the decision, Chen wrote that there was little dispute as to whether fluoride poses a hazard to human health. 

“Indeed, EPA’s own expert agrees that fluoride is hazardous at some level of exposure,” he wrote. “And ample evidence establishes that a mother’s exposure to fluoride during pregnancy is associated with IQ decrements in her offspring.”

Still, the EPA balked at any hint of public health danger.

“Notwithstanding recognition by EPA’s expert that fluoride is hazardous, the EPA points to technicalities at various steps of the risk evaluation to conclude that fluoride does not present an unreasonable risk,” Chen wrote. “Primarily, the EPA argues the hazard level and the precise relationship between dosage and response at lower exposure levels are not entirely clear.”

Chen did not find those arguments persuasive.

“Importantly, the chemical at issue need not be found hazardous at the exposure level to establish that a risk is present under Amended TSCA,” he wrote. “Instead, the EPA requires that a margin exist between the hazard level and exposure level to ensure safety; if there is an insufficient margin then the chemical poses a risk.”

And under that test the current standard fails, Chen found.

“The trial evidence in this case establishes that even if there is some uncertainty as to the precise level at which fluoride becomes hazardous (hazard level), under even the most conservative estimates of this level, there is not enough of a margin between the accepted hazard level and the actual human exposure levels to find that fluoride is safe,” he wrote. “Simply put, the risk to health at exposure levels in United States drinking water is sufficiently high to trigger regulatory response by the EPA under Amended TSCA.”

That evidence concluded that a 1-point drop in IQ of a child is to be expected for each 0.28 mg/L of fluoride in a pregnant mother’s urine. 

“This is highly concerning, because maternal urinary fluoride levels for pregnant mothers in the United States range from 0.8 mg/L at the median and 1.89 mg/L depending upon the degree of exposure,” he wrote. “Not only is there an insufficient margin between the hazard level and these exposure levels, for many, the exposure levels exceed the hazard level of 0.28 mg/L.”

To be sure, Chen observed, the EPA challenged whether the 0.28 mg/L hazard level as measured in maternal urinary fluoride was appropriate for the risk evaluation, arguing that the hazard and exposure levels should not be expressed in maternal urinary fluoride because that metric reflects total fluoride exposure, not just exposure resulting from drinking fluoridated water from one’s community. Fluoride may also be ingested through tea, fish, toothpaste, and commercial food and beverages made with fluoridated water, Chen acknowledged. 

“Nonetheless, the risk analysis should consider the additive effect of the chemical under the subjected condition of use (here, fluoridated community drinking water), especially where, as here, the fluoridated drinking water is a significant (and likely primary) contributor to aggregate exposure to fluoride,” he wrote. “Indeed, the Amended TSCA expressly contemplates that the aggregate exposure to a chemical will be considered when conducting a risk assessment. In this sense, maternal urinary fluoride is not just an acceptable metric, it is highly useful in assessing the real-world end result of exposure from drinking fluoridated water along with other sources.”

In sum, Chen found, there was substantial and scientifically credible evidence establishing that fluoride poses a risk to human health.

“[I]t is associated with a reduction in the IQ of children and is hazardous at dosages that are far too close to fluoride levels in the drinking water of the United States,” he said. “And this risk is unreasonable under Amended TSCA. Reduced IQ poses serious harm. Studies have linked IQ decrements of even one or two points to e.g., reduced educational attainment, employment status, productivity, and earned wages.” 

Indeed, Chen stressed, the EPA recognizes that reduction of IQ poses a serious community health issue. Moreover, highly susceptible populations are impacted, a number Chen said far exceeded the population size the EPA has looked to in determining whether regulatory action is warranted in other risk evaluations (i.e., 500 people or less).

“The size of the affected population is vast,” he wrote. “Approximately 200 million Americans have fluoride intentionally added to their drinking water at a concentration of 0.7 mg/L. Other Americans are indirectly exposed to fluoridated water through consumption of commercial beverages and food manufactured with fluoridated water.”

Not to mention pregnant women and their babies, Chen noted.

“Approximately two million pregnant women, and over 300,000 exclusively formula-fed babies are exposed to fluoridated water,” he wrote. “The number of pregnant women and formula-fed babies alone who are exposed to water fluoridation each year exceeds entire populations exposed to conditions of use for which EPA has found unreasonable risk; the EPA has found risks unreasonable where the population impacted was less than 500 people.”

What’s more, Chen wrote, individuals are exposed to fluoride through water intake every day; and the parties did not dispute that frequency of exposure for most people is several times daily, such as through drinking tap water. 

“And the duration of exposure to fluoridated water is continuous with its effects long-lasting,” he wrote. “To this end, fluoride remains in the body through years; for several years after cessation of fluoride exposure a woman is likely to release fluoride into blood due to skeletal breakdown.”

The scientific literature in the record provides a high level of certainty that a hazard is present, Chen concluded. 

“There are uncertainties presented by the underlying data regarding the appropriate point of departure and exposure level to utilize in this risk evaluation,” he wrote. “But those uncertainties do not undermine the finding of an unreasonable risk.”

What is certain, Chen continued, is that fluoride is associated with negative cognitive impacts.

“There is significant certainty in the data set regarding the association between fluoride and reduced IQ,” the judge wrote. “Namely, there is a robust body of evidence finding a statistically significant adverse association between fluoride and IQ. A large majority of the 72 epidemiological studies assessed by the NTP Monograph (United States National Toxicology Program review of available literature) observed this relationship including all but one of the 19 high-quality studies, and literature published after the NTP Monograph cutoff date observed the same relationship — and countervailing evidence, for various reasons described previously, are of little impact on this repeated, and consistently observed association between fluoride and reduced IQ.”

Moreover, Chen wrote, complete consistency among studies is not expected. 

“Notably, notwithstanding inherent difficulties in observing this association at lower exposure levels, studies assessing such levels still observed a statistically significant relationship between fluoride and reduced IQ,” he wrote. “Again, to put the breadth of evidence supporting this finding in perspective, the EPA has identified a LOAEL (lowest-observed-adverse-effect level) based upon far less in other contexts. For instance, in the EPA’s risk evaluation of Methylene, conducted pursuant to Amended TSCA, the EPA used a LOAEL for developmental neurotoxicity derived from the analysis of one study conducted upon mouse pups.”

Compare that with six (water fluoride) and nine (urinary fluoride), high-quality, epidemiological studies of human populations, Chen observed: “The scientific literature in the record provides a high level of certainty that a hazard is present; fluoride is associated with reduced IQ. The qualitative evidence is superior.”

In sum, Chen concluded, three factors weigh toward finding the risk unreasonable. 

“Namely, the severity of the hazard weighs toward finding the risk unreasonable,” he wrote. “The exposure-related considerations and exposure of susceptible populations weighs strongly toward finding the risk unreasonable; millions of susceptible individuals are exposed to fluoride and the exposure is frequent and long-lasting.”

The two final factors — confidence in hazard data and overall strength of the evidence and uncertainties — are largely neutral, he acknowledged. 

“Because the first three factors weigh strongly toward finding the risk unreasonable and the last two are largely neutral, the totality of the factors establish that the risk is unreasonable under the Amended TSCA,” Chen concluded. “The court thus finds that the plaintiffs have established by a preponderance of the evidence that the risk at issue is unreasonable.”

Richard Moore is the author of “Dark State” and may be reached at richardd3d.substack.com.