A groundbreaking battle in the US Federal Court against America’s mighty Environmental Protection Agency is underway
- More than three years years have passed since a petition was submitted to the US Environmental Protection Agency under Section 21 of the Toxic Substances Control Act to stop fluoridation chemicals being added to America’s drinking water based on neurological damage being caused to the fetus, infant and child;
- After desperate attempts by the EPA to dismiss the petition and limit review and discovery of evidence in various depositions, a Federal Court trial was scheduled for 8 June 2020;
- The Plaintiff presented four key witnesses whose credentials were outstanding and testimonies were powerful;
- The Defendant presented two key witnesses whose credentials and testimonies were embarrassingly biased;
- The EPA was represented by a team of lawyers from the US Department of Justice, costing the taxpayer millions of dollars;
- The Plaintiff’s legal representation was funded by donations from individuals;
- The first stage of this 7-day ‘virtual’ trial concluded on Wednesday 17 June 2020;
- The next hearing is scheduled for 10am (San Francisco time) on Thursday 6 August 2020, via Zoom.
In November 2016, a coalition of not-for-profit groups (including Fluoride Action Network) and other individuals filed a petition calling on the US Environmental Protection Agency (EPA) to ban the deliberate addition of fluoridation chemicals to America’s drinking water. Specifically, the Petition was submitted under Section 21 of the Toxic Substances Control Act (TSCA) which authorizes EPA to prohibit the “particular use” of a chemical that presents an unreasonable risk to the general public or a susceptible subpopulation. TSCA also gives EPA the authority to prohibit drinking water additives.
The basis of this petition was a large body of animal, cellular, and human research showing fluoride is a neurotoxic at doses within the range now seen in fluoridated communities. As many independent scientists now recognise, fluoride is a neurotoxin. The question, therefore, is not if fluoride damages the brain, but at what dose.
Fortunately the TSCA statute provides the ability for citizens to challenge an EPA petition denial in federal court. So after more than three years, including desperate attempts by the EPA to reject and dismiss the petition and then to limit review and discovery of evidence in several depositions, a US Federal Court trial was scheduled for early February 2020. A global pandemic, however, temporarily thwarted proceedings, until the presiding judge Edward Chen, ascertaining the urgency of this trial, departed from the traditional court-room hearing and scheduled a trial via Zoom on 8 June 2020. This groundbreaking ‘virtual’ trial was therefore open to the public worldwide.
Details of the case
- The case is Food & Water Watch Inc. et al. v. EPA et al., in the US District Court for the Northern District of California (San Francisco);
- Presiding Judge: Edward M. Chen;
- The Plaintiff is represented by attorneys Michael Connett and Andy Waters of California legal firm Krauss, Waters and Paul;
- The EPA is represented by a team of lawyers form the US Department of Justice.
The Plaintiff is claiming:
- neurotoxicity is a hazard of fluoride exposure;
- this hazard exists at the doses ingested in fluoridated areas; and
- the risk is unreasonable.
The Plaintiff’s four key witnesses
- Howard Hu MD;
- Bruce Lanphear MD;
- Philippe Grandjean MD; and
- Kathleen Thiessen PhD.
The EPA has relied on the research and advice of all of these experts in the past for other toxicants like lead and mercury. All four have significant experience in fluoride research with Drs Hu and Lanphear both authors of key fluoride studies funded by US government agencies. Drs Grandjean and Thiessen have been involved with fluoride research for many years; both having performed fluoride reviews or risk assessments.
The Defendant’s two key wittnesses
- Ellen Chang ScD, and
- Joyce Tsuji Ph
Given the lack of expertise on fluoride within the EPA it was not surprising they did not rely on internal (EPA) key witnesses. But it was surprising they chose these two experts from Exponent – a consulting company renowned for its work on behalf of many polluting industries. In fact Chang and Tsuji have defended some of the most notorious pollutants known to man (see their testimonies below for more details).
Joyce Donohue PhD
The Plaintiff’s first expert witness was Joyce Donohue PhD, who has worked in the EPA’s Office of Water since 1996 and has been their spokesperson on fluoride. Her testimony was based on a video recording of her five-hour deposition in 2019. From Donohue’s deposition and testimony it was established: a) the EPA had no studies as evidence to show the fetus was safe from neurotoxicity, rather they only had studies showing harm; and b) she would recommend the EPA and other regulatory bodies conduct risk assessments of the neurotoxicity of fluoride as an end point. So far all EPA risk assessments have only been based on potential damage to the teeth and the bone.
Howard Hu, MD, MPH, ScD
The next expert witness was Howard Hu, MD, MPH, ScD. Dr. Hu’s credentials are very impressive, having led international teams investigating the environmental, nutritional, social, and epi/genetic determinants of chronic disease and impaired child development in population-based studies in the US, Mexico, India, China, and elsewhere around the world.
Hu outlined his specific work on fluoride as the Principal Investigator for the Bashash et al, 2017 and 2018 studies, including the painstaking steps it took to have his study funded by the NIH and then accepted for publication in the prestigious Environmental Health Perspectives (EHP) journal. Dr Hu also summarised the importance of his study, stressed the significance of a loss of 3 or 4 IQ points at the population level and highlighted the parallel with lead’s neurotoxicity.
Dr Philippe Grandjean MD, ScD
The next expert witness was Dr Philippe Grandjean MD, ScD, a medical doctor and scientist and an internationally known expert in environmental epidemiology. Grandjean has held grants and/or consulted with the EPA itself, the National Institutes of Health, the US Food and Drug Administration, the World Health Organization, and numerous other bodies over 25 years. He is the author or co-author of around 500 scientific papers and author of the book, Only One Chance, where he warns of the dangers of exposing children to neurotoxicants during early development, especially during the fetal stage.
The DOJ lawyer attempted to undermine Grandjean’s credibility but this was difficult given his impressive credentials, his extensive neurotoxic research and also given the EPA has specifically relied on him for his expert advice on mercury and other neurotoxicants.
Grandjean has conducted research on fluoride since the 1980s. In 2012 he published a meta-analysis (Choi et al 2012) of 27 fluoride-IQ studies, which found a glaringly consistent result. Of these 27 studies, 26 found a lowering of IQ in the children with higher fluoride exposure.
For this legal case Grandjean updated his 2012 meta-analysis to include the most recent US government-funded studies. In doing so he quantified the risk of IQ loss from fluoride to children using a Benchmark Dose (BMD) study – as also used by the EPA – and concluded that a safe reference dose (RfD) be no higher than 0.15 mg per day to protect against a loss of one IQ point. This amount is reached by a pregnant mother after drinking just one glass of fluoridated tap water a day – well below the exposure levels in the Bashash and Green studies.
Finally, Dr Grandjean found “no reasonable doubt that developmental neurotoxicity” was “a serious human health risk associated with elevated fluoride exposure.” That exposure, he said, is “occurring at the levels added to drinking water in fluoridated areas.”
Bruce Lanphear, MD
Dr Bruce Lanphear, Professor of Health Sciences at Simon Fraser University in Canada, is a world-renowned expert on the neurotoxicity of chemicals. He is one of the EPA’s main authorities on lead neurotoxicity and his research on environmental contaminants has been funded in part by the EPA.
Dr Lanphrear revealed he was not being compensated for his work in this legal case; instead he said it was part of his “public service duty to participate” and protect our children from harm. “We’ve allowed children with rapidly growing brains to be exposed to toxins,” Lanphear told the court.
Dr Lanphear explained that the Till 2018 study showed that the levels of fluoride levels in mothers’ urine in fluoridated cities in Canada (0.87 ppm) were very similar to the levels found in Mexico City in the Bashash studies (0.91 ppm). These levels are also very similar to fluoride levels in Australia.
He explained that the Green 2019 study essentially replicated the findings in the Bashash study, namely that there was a strong relationship between mothers’ urine levels and lowered IQ in their offspring at 3-4 years of age, except they found this relationship in the boys and not the girls. He explained this was not an unusual finding in development neurotoxicity studies; the same sex differences had been observed in some studies on lead and also in Mullenix’s 1995 landmark animal study.
Finally, Dr Lanphear described the infancy exposure study of Till 2020 (pre-published in November 2019). In this study the research team compared the IQ of formula-fed children who lived in fluoridated communities as babies to those who lived in non-fluoridated communities. They found a large drop of IQ in the non-verbal component of the IQ tests for the children who as babies were bottle-fed with formula in fluoridated communities.
Casey Hannan, Director of the CDC’s Division of Oral Health
Next on the stand was Casey Hannan, Director of the Centre’s for Disease Control’s Division of Oral Health. As an “expert witness”, Hannan’s “expertise” is a stark contrast to the extraordinary credentials of Drs Hu, Lanphear, Grandjean and Thiessen. As a director of America’s leading national public health institute that claims to the world that fluoridation is “One of the top public health achievements of the Twentieth century,” Hannan has none of the impressive credentials of the Plaintiff’s four key witnesses.
Hannan was clearly out of his depth regarding possible harm caused by fluoride and was unable to offer any evidence showing fluoride does not cause any neurological damage to the fetus, infant or child. As he acknowledged, the focus of the CDC Oral Health Division is in promoting the benefits of water fluoridation for fighting tooth decay, and that they rely on other agencies to provide any evidence of harm.
Under cross examination Hannan revealed the CDC’s reliance on the NRC’s (2006) report Fluoride in Drinking Water – now 14 years old – for their knowledge of the harm fluoride may cause. But even this comprehensive report should have triggered remedial action or substantial neurotoxic studies by the CDC.
Kristina Thayer PhD
Next was Kristina Thayer PhD, who previously worked at the National Toxicology Program (NTP) and oversaw a systematic review of animal studies on the neurotoxicity in 2016. Thayer is the current director of the EPA’s Chemical and Pollutant Assessment Division. In her testimony she stated:
“While there are limitations to the data collected in studies of the impact of fluoride exposure on animals, the animal studies support the conclusion that fluoride causes neurotoxic effects in humans. The human brain is more vulnerable to toxic agents at infancy than adulthood because infants don’t have fully developed blood-brain barriers.”
The EPA attorney’s spent considerable time having Dr. Thayer explain what she considered to be the most methodologically superior systematic review process, and how such a review hasn’t been conducted on fluoride. Then, under cross examination, Thayer confirmed the EPA had never actually completed a risk assessment of this nature on any of the chemicals they have regulated using the methods just suggested for fluoride. This revealed the abnormally high hurdles that only seem to exist for fluoride.
Kathleen Thiessen, PhD
The Plaintiff’s last expert witness was, Dr. Kathleen Thiessen. This included a second failed attempt to have Dr. Thiessen’s testimony thrown out due to claims that she didn’t consider the potential benefits of fluoride in reducing dental decay. Not only did Thiessen consider these factors, but concluded decisively that the health risks of fluoride outweighed any claimed benefits. She was also attacked for her past efforts to educate the public about the evidence of harm from fluoridation, in lieu of the EPA not doing their job and warning citizens.
Thiessen’s written statement is a textbook example of how to construct a risk assessment using EPA’s methodology.
Joyce Tsuji, PhD
The EPA then called their first expert witness, Joyce Tsuji, PhD from corporate consulting firm Exponent. This is the same scientists-for-hire firm the tobacco industry used to deny lung cancer risk.
In her declaration, Tsuji stated; “The overall weight of the scientific evidence does not establish a strong, consistent, coherent, or biologically plausible association between consumption of fluoridated drinking water in the range of 0.7 mg/L and adverse neurodevelopmental outcomes in humans . . .”
Tsuji talked a lot and said little. Her long, vague and meandering answers repeatedly contradicted the testimony from her pre-trial deposition. In fact the judge interrupted proceedings to warn her on two occasions.
Tsuji, however, admitted “there is enough literature for us to be concerned” about fluoride’s neurotoxicity.
Dr. Ellen Chang
The EPA then called their second expert witness, Dr. Ellen Chang (also from Exponent), to discuss the human fluoride/IQ studies. She spent much of her time attacking the quality of the studies linking fluoride to lowered IQ that were NIH funded, peer-reviewed, and published in leading scientific and medical journals.
But Chang’s blatantly biased attitude became apparent when she praised an abstract of a study that claims to have found fluoride exposure actually increased IQ. Despite not being accepted by a publication since being made public over 10-months ago, never being peer-reviewed, and the methodology remaining a mystery, Dr. Chang said she assumed – without any justification – this was a higher quality study than those studies finding IQ loss. Even the judge was surprised, asking how she could make such assumptions.
Chang’s defense sounded remarkably similar to the approach taken by Australia’s NHMRC when, in their 2017 review, they referred to the Broadbent et al study (2015) as a “high quality” study with “low risk of bias”.
A list was presented showing 92 human studies Dr. Chang reviewed. She picked out 10 as the strongest and most relevant and then from this list she admitted that five of these were the strongest studies she identified – all showing lowered IQ, including the highly-regarded Mexican and Canadian studies. Again this contradicted her “weight of scientific evidence” statement she made in her declaration.
The Plaintiff’s attorney also investigated Chang’s track record, defending highly-toxic chemicals on behalf of multinational polluters such as Dow Chemicals, Monsanto and 3M. Another list was presented showing 12 published studies by Dr. Chang between 2014 and 2019. This horror list included her defense of Agent Orange/dioxin, PFOA/PSAS, arsenic, glyphosate, paraquat and chloroform, among other toxic substances. It became quite obvious that Dr. Chang has problems finding problems.
Specifically, Chang had found there was no convincing or causal evidence that Agent Orange caused certain cancers, despite papers from the US Veterans’ Administration, stating that Agent Orange was the cause of several cancers. Chang replied that her definition of “causation” was different from the VA’s definition. But her definition and methodology were clearly designed to protect industry’s profits rather than protect the veterans whose lives had been devastated by this dangerous chemical.
In essence, Chang’s blatant bias and long track record of being on the wrong side of history and science had been exposed.
Dr Tala Henry
Next up was Dr Tala Henry, Director of the EPA’s Risk Assessment Division. With 25 years of risk assessment experience at the agency, her testimony focused on the many hurdles involved in conducting a risk assessment/evaluation of a chemical. Henry indicated that the Plaintiff’s experts had not overcome all those hurdles to her satisfaction.
Under cross examination the Plaintiff’s lawyer emphasised she wasn’t an expert on fluoride, that her testimony in this trial contradicted in many ways what she had said in her deposition testimony, and in fact, that she wasn’t a credible expert witness.
Also during cross-examination Dr Henry was asked;
“You held the plaintiffs to a burden of proof that EPA has not held a single chemical under section 6 [of the Toxic Substances Control Act] before, correct?”
“By the words on the page, I guess that’s true,” Henry replied. “But it was really, my opinion was based mostly on the methodological problems.”
The EPA’s attorney summarised their expert witnesses’ testimony, when at one point the lawyer, who obviously thought her microphone was muted, said; “This is not helpful!”
The closing statements
Closing statements for the Plaintiff by attorney Michael Connett
“In this case we have held accountable an agency, that at least on this particular issue, has failed to responsibly carry out its duties to protect this nation from harm.”
“At the beginning of this case I said there are three key questions that need to be answered: Is there a hazard? Is there a risk? And is the risk unreasonable? The undisputed evidence in this case, we submit, demonstrates that the answer to all three of these questions is YES.”
“TSCA commands that the EPA not just protect the general public. If there is one unreasonable risk, to just one susceptible subpopulation, the EPA must take action to remove such risk.”
“We brought before your honor, world class experts of the highest order. Experts that the EPA has consistently depended on for assessments…The EPA has based their regulations on lead and mercury on our experts.”
“It’s an undisputed fact in this case that approximately 200 million people live in communities where fluoridation chemicals are added to water, and many more drink processed beverages that have been contaminated with fluoridation chemicals. To put this number in context, Your Honor, the EPA has found unreasonable risks under Section 6 where the conditions of use impact less than 2,000 people. Because of the widespread reach of fluoridation, you have millions of susceptible people being exposed on a daily basis, including 2 million pregnant mothers and over 400,000 exclusively formula-fed babies.”
“We have four high quality cohort studies. Each has found associations between early life exposures to fluoride and lowered IQ…by around 5 IQ points. The effect size rivals the neurotoxic effects of lead.”
“There is no dispute that the developing brain is the most susceptible to neurotoxic side-effects.”
“The most likely explanation for the observed adverse effects…is that fluoride is a neurotoxin at the levels found in fluoridated communities across the United States.”
“It’s undisputed that fluoride will pass through the placenta into the brain of the fetus. It’s undisputed that babies who are bottle fed with fluoridated water receive the highest doses of fluoride in our population at the moment of greatest vulnerability. It’s undisputed that fluoride damages the brain.”
Michael Connett also pointed out that the experts the EPA relied upon, including the two Exponent employees, were not experts on fluoride, and that the agency did not call their own employees to answer key questions in the case. Additionally, he said the EPA never once attempted to determine an estimate of what the levels are that cause neurotoxic effects. Connett added that the EPA witness Dr. Donohue said the National Institutes of Health funded-studies on which the plaintiffs relied were “well conducted” and “warrant a reassessment of all existing” fluoride standards.
Closing statements for the EPA by attorney Debra Carfora (DOJ)
The EPA’s attorney started by questioning whether fluoride posed a hazard. The Judge soon interrupted her – which became a common occurrence – and said, “The way you’re framing this is not helpful. I don’t think anyone disputes that fluoride is a hazard…the critical question is at what level it poses a risk.”
The EPA’s closing statement turned into a 40-minute inquisition by the judge. He first questioned their claims that the animal studies showed fluoride to be safe and then reprimanded the EPA for challenging the reliability of Philippe Grandjean’s benchmark dose, despite never making the effort to calculate their own to prove their point. In desperation the EPA lawyers claimed the Canadian and Mexican studies weren’t applicable to the United States – a claim that possibly weakened their whole case.
The judge then asked the EPA one final question; “Under TSCA, can the court find an unreasonable risk without finding causation?” The EPA’s lawyer replied, “Yes.”
Judge Chen makes recommendations
After closing statements, Judge Chen immediately started sharing his views on the case and making recommendations.
“So much has changed since the petition was filed…two significant series of studies – respective cohort studies – which everybody agrees is the best methodology. Everybody agrees that these were rigorous studies and everybody agrees that these studies would be part of the best available scientific evidence.”
“The EPA appears to have applied a standard of causation, which from my read of TSCA is not accurate. It’s not a proper allocation. It’s not the proper standard.”
Judge Chen then asked the parties if they could discuss the possibility of an amended petition and re-assessment by the EPA, or start a new petition and have the EPA conduct a proper review, leaving his ultimate ruling until that was complete. It seemed that Judge Chen may have been providing the EPA with an opportunity to save face and correct their original errors.
Michael Connett pointed out that the EPA has dragged their feet for a “long, long time” – 14 years have passed since the NRC report recommended the EPA determine a new maximum allowable level for fluoride in drinking water. Connett said the EPA has made a political decision not to do anything, and this is exactly why the petition was filed in the first place. He also pointed out that the Plaintiff has already spent nearly four years working on and building this case, and that the time and resources necessary to go through the process a second time would be prohibitive.
At this point, the EPA claimed that they couldn’t just re-evaluate an amended petition, because their guidelines for TSCA require an impossible burden of proof that no one could possibly meet to trigger a meaningful review. They also claimed the EPA doesn’t have the resources or expertise to undertake a risk evaluation of fluoride neurotoxicity.
Judge Chen quickly retorted, stating a lack of resources within the EPA is not a valid excuse.
Michael Connett then emphasised that all the evidence presented in this trial cannot be ignored and therefore the EPA needs to do something now to protect or warn susceptible groups, such as pregnant mothers. He expressed his strong concerns that a risk assessment or review may result in this case being extended for years.
“I’m thinking months not years,” replied Judge Chen. “I don’t anticipate to be sitting on this case for years with no resolution.”
Judge Chen did not provide a ruling. Instead he suggested the parties meet again to discuss and agree on a procedural mechanism that is suitable to both sides and effectively said that if both parties can’t figure out a solution he’ll rule on it himself, as he has been given the power to do. The next hearing – a status conference – was scheduled for Thursday 6 August at 10:30am PDT.