2017-06-13 Unprecedented Lawsuit Could End Water Fluoridation in US Based on Neurotoxicity Studies

By Stuart Cooper
Campaign Director, Fluoride Action Network

The Fluoride Action Network (FAN), along with a coalition of environmental and public health groups has filed a complaint in the U.S. District Court for the Northern District of California against the U.S. Environmental Protection Agency (EPA) in response to their denial of our petition under Section 21 of the Toxic Substances Control Act (TSCA) seeking a ban on water fluoridation.

We believe this lawsuit is an unprecedented opportunity to end the practice once and for all in the U.S., and potentially throughout the world, based on the well-documented neurotoxicity of fluoride. You may read the official complaint here. According to FAN’s attorney and adviser, Michael Connett:

“This case will present the first time a court will consider the neurotoxicity of fluoride and the question of whether fluoridation presents an unreasonable risk under the Toxic Substances Control Act (TSCA).

And, in contrast to most other legal challenges of Agency actions, TSCA gives us the right to get the federal court to consider our evidence ‘de novo’ — meaning federal courts are to conduct their own independent review of the evidence without deference to the EPA’s judgment.”

Industry, legal and environmental observers following the EPA’s implementation of the new TSCA law have pointed out that a lawsuit¹ challenging the EPA’s denial of our petition would provide a test case for the agency’s interpretation that petitioners must provide a comprehensive analysis of all uses of a chemical in order to seek a restriction on a particular use.

Legal experts have suggested the EPA’s interpretation essentially makes the requirements for gaining Agency action using section 21 petitions impossible to meet, making the outcome significant for all U.S. residents and public health or environmental watchdog groups.

Lawsuit Background: EPA Served With Citizen’s Petition

On November 22, 2016, a coalition including FAN, Food & Water Watch, Organic Consumers Association, American Academy of Environmental Medicine, International Academy of Oral Medicine and Toxicology, Moms Against Fluoridation and several individual mothers, filed a petition calling on the EPA to ban the deliberate addition of fluoridating chemicals to the drinking water under provisions in the Toxic Substances Control Act (TSCA).

The petition includes more than 2,500 pages of scientific documentation detailing the risks of water fluoridation to human health.The full petition can be accessed here, a shorter eight-page summary here and our press release here.

We presented the FDA with a large body of human and animal evidence demonstrating that fluoride is a neurotoxin at levels now ingested by many U.S. children and vulnerable populations. We also presented the agency with evidence showing that fluoride has little benefit when swallowed and, accordingly, any risks from exposing people to fluoride chemicals in water are unnecessary.

We believe an impartial judge reviewing this evidence will agree that fluoridation poses an unreasonable risk. On February 27, 2017, the EPA published their response.² In their decision, the EPA claimed:

“The petition has not set forth a scientifically defensible basis to conclude that any persons have suffered neurotoxic harm as a result of exposure to fluoride in the U.S. through the purposeful addition of fluoridation chemicals to drinking water or otherwise from fluoride exposure in the U.S.”

As many independent scientists now recognize, fluoride is a neurotoxin.³ The question, therefore, is not if fluoride damages the brain, but at what dose. While EPA quibbles with the methodology of some of these studies, to dismiss and ignore these studies in their entirety for methodological imperfections is exceptionally cavalier, particularly given the consistency of the findings and the razor-thin margin between the doses causing harm in these studies and the doses that millions of Americans now receive.

EPA’s own Guidelines for Neurotoxicity Risk Assessment highlights the importance of having a robust margin between the doses of a chemical that cause neurotoxic effects and the doses that humans receive. FAN presented the EPA with over 180 studies showing that fluoride causes neurotoxic harm (e.g., reduced IQ), pointing out that many of these studies found harm at levels within the range, or precariously close to, the levels millions of American children now receive.

Typically, this would be a cause for major concern. But, unfortunately, the EPA has consistently shied away from applying the normal rules of risk assessment to fluoride — and it has unfortunately continued that tradition with its dismissal of our petition.

Fortunately, the TSCA statute provides citizens with the ability to challenge an EPA denial in federal court. For too long, EPA has let politics trump science on the fluoride issue (see examples). FAN welcomes having these issues considered by a federal court, where scientific evidence has a better chance of being weighed objectively.

To accompany our lawsuit, FAN is offering a new DVD and a comprehensive campaign flash drive package. The DVD features the video, “Fluoride and the Brain,” in which Michael Connett explains that fluoride’s ability to lower IQ in children is just the tip of an iceberg of over 300 animal and human studies that indicate that fluoride is neurotoxic.

We have also made a comprehensive collection of campaign and educational videos available on a single flash drive for a limited time. It also includes our EPA petition and supporting documentation. This is a must-have for every fluoride-free campaigner’s toolkit.⁴  Another must-have is the book “The Case Against Fluoride,” by environmental chemist and toxicologist Paul Connett, Ph.D., which contains a comprehensive science-based argument for the end to artificial water fluoridation.

Winning this lawsuit will require a full team effort, and we want you to feel a part of that team and a part of this moment in history. Please consider playing a larger role in this potentially fluoridation-ending lawsuit by making a tax-deductible contribution.

New Study Quantifies Fluoride’s Potential to Lower IQ in Children

Since submitting our citizen’s petition to the EPA, we have learned even more about the threat to the next generation. Some children in the U.S. may be consuming enough fluoridated water to reach doses of fluoride that have the potential to lower their IQ, according to a research team headed by William Hirzy, Ph.D., a former senior scientist at the EPA who specialized in risk assessment and published an important risk analysis in the journal Fluoride last year.⁵

Current federal guidelines encourage the addition of fluoride chemicals into water supplies to reach 0.7 milligrams per liter (mg/L). Hirzy followed EPA risk assessment guidelines to report: “The effect of fluoride on IQ is quite large, with a predicted mean 5 IQ point loss when going from a dose of 0.5 mg/F/day to 2.0 mg F/day.”

Many children in the U.S. commonly consume these levels of fluoride within this range from all sources (i.e., water, food, dental products, medicines and air pollution). Hirzy explains the significance of this study:

“The significance of this peer reviewed risk analysis is that it indicates there may be no actual safe level of exposure to fluoride. Groups of children with lower exposures to fluoride were compared with groups having higher exposures. Those with higher exposures performed more poorly on IQ tests than those with lower exposures.

One well-conducted Chinese study indicated that children exposed to 1.4 mg/day had their IQ lowered by 5 IQ points. Current average mean daily intakes among children in the United States are estimated by EPA to range from about 0.80 mg/day to 1.65 mg/day. Fluoride may be similar to lead and mercury in having no threshold below which exposures may be considered safe.”

Dr. Bill Osmunson, FAN’s interim director, noted that this risk analysis adds further weight to the petition submitted to the EPA by FAN and other groups in November to ban the addition of fluoride chemicals to drinking water under provisions in the Toxic Substances Control Act.

FAN’s Persistence Pays Off: US Government Funding Neurotoxicity Studies

FAN progress isn’t limited to the legal world. Our relentless effort to get the U.S. government to take fluoride’s neurotoxicity seriously is also beginning to pay off in other ways. For many years, American regulatory and research agencies have failed to finance studies seeking to reproduce the many studies undertaken abroad that have found harm to the brain (over 300).

When toxicologist and pharmacologist Phyllis Mullenix, et al., published their groundbreaking animal study⁶ on fluoride and animal behavior in 1995, she was fired from her position as chair of the toxicology department at the Forsythe Dental Center. That sent a chilling message to U.S. researchers — research on fluoride toxicity is a “no-go” area. But that is changing. Now, with the U.S. government funding several important toxicology studies, this should encourage other Western researchers to get involved:

There is a new National Institutes of Health (NIH) funded fluoride/brain study.7 Our Canadian friends are extremely excited by this research funding to Christine Till and Ashley Malin, the co-authors of the important study that found a correlation between fluoridation and increased ADHD rates in the U.S.8 This could definitely be one of the most important developments in water fluoridation to date.

The National Toxicology Program (NTP) is in the process of completing a rodent study using low levels of fluoride exposure. However, we have concerns over the consultation process NTP had prior to when this study was undertaken (see “Vigilance Still Needed” at end of this article).

Dr. Philippe Grandjean, Harvard School of Public Health, is leading an ongoing study of fluoride and intelligence among a group of schoolchildren in China. Grandjean published the preliminary results of this study in the January to February 2015 issue of Neurotoxicology & Teratology.9

A National Institute of Environmental Health (NIEHS)-funded human epidemiological study titled “Prenatal and Childhood Exposure to Fluoride and Neurodevelopment” is investigating the relationship between fluoride and IQ among a cohort of children in Mexico. A summary of the study10 is available online.

An NIEHS-funded animal study, “Effects of Fluoride on Behavior in Genetically Diverse Mouse Models,” is investigating fluoride’s effects on behavior and whether these effects differ based on the genetic strain of the mouse. The principal investigator of the study is Dr. Pamela Den Besten. A summary of her study11 is available online.

The NIH is funding a study investigating the impact of fluoride on the timing of puberty among children in Mexico. This study is pertinent to the assessment of fluoride’s impact on the pineal gland’s regulation of melatonin. The preliminary results of the study were presented at the 2014 Independent School Entrance Examination ISEE conference and can be accessed online.12

Though not funded by the U.S. government, Jaqueline Calderón Hernandez, Ph.D., Universidad Autónoma de San Luis Potosí, Mexico, is currently working with Diana Rocha-Amador, Ph.D., on three studies on fluoride neurotoxicity: 1. An examination of the cognitive effects from fluoride in drinking water 2. Estimating the global burden of disease of mild mental retardation associated with environmental fluoride exposure 3. Investigating the impact of in utero exposure to fluoride (via drinking water) on cognitive development delay in children

Rocha-Amador is also examining the impact of fluoride on thyroid hormone levels in pregnant women, and published a fluoride/IQ study in 2007.¹³

Vigilance Still Needed

We still have to be vigilant to make sure that those determined to protect the fluoridation program don’t skew the results. For example, it is worrying that the NTP specified that an animal study should be conducted at 0.7 ppm — which is a ridiculous provision for an animal study on fluoride. For example, it is well-known that rats need a much higher dose of fluoride in their water to reach the same plasma levels in humans.

Moreover, it is standard practice in toxicology to use much higher doses in animals to tease out effects. To conduct experiments on animals at expected human doses would require a huge number of animals, which would be cost prohibitive. These studies also raise a significant question for those who continue to promote fluoridation in local communities and legislatures around the world.

“What primary scientific studies (not bogus reviews conducted by pro-fluoridation agencies) can you cite that give you the confidence to ignore or dismiss the evidence that fluoride damages the brain as documented in over 300 animal and human studies (including 50 IQ studies)?”

As shown by its support for these new neurotoxicity studies, our own government has acknowledged the risk fluoride poses to our children. If proponents cannot provide an adequate scientific answer to this question, then fluoridation should be halted immediately, and should under no circumstances be initiated.

National Fluoridation Stats Show Tipping Point Has Been Reached

Progress is also being made on the political front. U.S. Center for Disease Control (CDC) fluoridation statistics for the U.S. have been released for 2014,¹⁴ and they show exactly why the fluoridation lobby has been pouring more money and resources into promoting the practice and fighting our efforts: WE ARE WINNING!

For the first time in nearly 40 years, the percentage of the U.S. population served by community water systems receiving fluoridated water decreased, from 74.6 percent to 74.4 percent. The percentage of the U.S. population receiving optimally fluoridated water (natural and artificial) also decreased, from 67.1 percent to 66.3 percent. Also decreasing:

• The number of water systems providing fluoridated water (natural or artificial)
• The number of water systems adding fluoride
• The number of water systems providing naturally “optimal fluoride” levels

Momentum Continues to Build Thanks to Citizens Like You

More than 460 communities throughout the world have ended existing fluoridation programs or rejected new efforts to fluoridate either by council vote or citizen referendum since 1990. Since January 2016 alone, we’ve confirmed that at least 33 communities with nearly a million collective residents voted to end fluoridation, bringing the number of victories since 2010 to at least 225 communities,¹⁵ representing approximately 6.5 million people.

Most of these victories were the result of citizens organizing local campaigns and voicing their opposition to public officials, with many working in coordination with FAN or using our materials to educate their neighbors and local decision makers about the serious health risks associated with the practice. Some of the latest victories in the U.S. and abroad include:¹⁶

Kennebunk, Kennebunkport and Wells Water District, Maine (30,000)	Mackay Regional Council, Australia (124,724)
Albuquerque, New Mexico (157,428)	Gladstone Regional Council, Queensland, Australia (73,335)
Newport, Oregon (10,120)	Bedford, England, U.K (166,252)
Bedford Regional Water Authority, Virginia (25,000)	Wakefield, England, U.K. (77,500)
Guilford Township, Pennsylvania (26,000)	Cornwall, Ontario, Canada (46,340)
Whakatane, New Zealand (37,000)	La Ville de Trois-Rivieres, Quebec, Canada (135,054)

Help us continue this momentum by supporting the efforts of FAN, and by joining or initiating your own local campaign to end artificial water fluoridation. FAN would like to thank Dr. Mercola for his continued support and generosity in raising our awareness of the risks from overexposure to fluoride.