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TSCA/EPA WATER FLUORIDATION TRIAL ENTERS A NEW PHASE
Those who have been following the TSCA EPA water fluoridation trial in Federal Court (U.S. District Court in San Francisco) might be wondering if the Court has made a judgement. It has not.
On the last day of trial (6/18/2020), explaining reasons for postponing a judgement, the Court noted, “So much has changed since the petition was filed … two significant series of studies – prospective 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.”
At the 8/6/2020 status hearing, the Court directed attorneys for the plaintiffs to submit a new petition to EPA, including the peer-reviewed mother-offspring studies showing fluoride neurotoxic risk published in the three years since the original petition was filed, notably the ELEMENT (Mexico) and MIREC (Canada) studies, then return for a second status hearing 11/8/2020.
According to Bloomberg Law, the Court “intimated that it would be prudent for the EPA to find a way to reduce the risk of adding fluoride to drinking water — without being compelled to do so by the court.”
For background, see below.
JUDGEMENT ON HOLD IN TSCA EPA WATER FLUORIDATION CASE
3:17-cv-02162-emc – Food & Water Watch, Inc. Et Al V. Environmental Protection Agency Et Al.
Carol Goodwin Blick / The Sonoma County Gazette (July 2020)
On Nov. 22, 2016, a Citizens’ Petition was presented to the Environmental Protection Agency (EPA) under Section 21 of the Toxic Substances Control Act (TSCA). The Petition requested EPA “to protect the public and susceptible subpopulations from the neurotoxic risks of fluoride by banning the addition of fluoridation chemicals to water,” exercising its authority to prohibit the addition of fluoridation chemicals to U.S. water supplies on the grounds that a large body of an animal, cellular, and human research indicates that fluoride is neurotoxic at doses within the range now seen in fluoridated communities. In 2017, after EPA denied the Citizen Petition, a suit was filed in federal court in San Francisco, as allowed under TSCA. The trial began Monday, June 8, 2020, and final arguments were heard Thursday, June 18, 2020. For the first time in its 44-year history citizens reached the trial stage of a lawsuit under TSCA.
SOME OF THE SCIENCE UNDERGIRDING THE SUIT
The most robust studies indicate that fluoride poses an unacceptable neurotoxic risk to the 200 million in the U.S. who currently receive artificially fluoridated tap water, with the greatest risk to perinatal infants and children.
Based on body weight, infants and young children have approximately three to four times greater exposure than adults, with the greatest exposure to bottle-fed infants. SOURCE: National Research Council. (NRC 2006).
Two U.S. government-funded, well-designed, large, long-term, prospective cohort studies, ELEMENT (Mexico) and MIREC (Canada), published since the initial petition, were especially impressive.
EPA agrees that the cohort studies are well designed, but rejects the rigorous risk assessments of the plaintiffs’ internationally respected expert witnesses, preferring a standard EPA risk assessment of fluoride.
EPA has protocols for determining unacceptable risk of neurotoxins, and for determining a safe dose, if any, below which the risk is acceptable, but over many decades of endorsing water fluoridation, EPA has never completed a risk assessment of fluoride. However, about a year ago, well after the lawsuit was filed, EPA began its first official assessment of fluoride, a process that EPA’s lead attorney says will take at least two more years to complete.
However, Judge Edward M. Chen (the Court) stated that EPA is applying the wrong standard to fluoride, looking for causation of harm, instead of risk of harm. Risk alone is the standard mandated by statute, and any evaluation done under EPA’s current standard will be legally flawed, including the EPA risk assessment currently underway.
After final arguments concluded on Thursday, June 18th, the Court made a surprise proposal that judgment be deferred while EPA and the plaintiffs discuss a solution that will satisfy both.
While there is no way to know how the Court would rule if a final judgement were requested, the Court appears convinced by the evidence that fluoride poses an unacceptable neurotoxic risk to humans, with the greatest risk to perinatal infants and children.
The Court would like the plaintiffs to consider submitting a new petition, including studies not yet published when the petition was filed. As the Court noted, strong science on fluoride neurotoxicity is “accumulating all the time.” The court also suggested that the plaintiffs might themselves do, and submit, the formal EPA-standard risk assessment EPA says it requires but has not yet done. The Court appears to expect EPA, guided by the incontrovertible science, to accept the new petition and the new risk assessment, and reverse its water fluoridation policy. Attorneys for both sides expressed strong reservations.
CONCERNS ALL AROUND
EPA’s U.S. Justice Department attorney Debra Carfora explained that, by law, EPA must respond to a petition within 90 days. EPA’s risk assessment process alone takes a minimum of 3 years, and evaluating the studies referenced in the petition could take even more time so, of course, EPA rejected the first petition, and would reject a second, no matter how excellent.
Michael Connett, lead attorney for the plaintiffs, explained that this is a citizens’ suit, that it has taken almost four years and considerable effort and expense (even though the legal team is working pro bono, and plaintiffs’ expert witnesses testified from “a sense of civic duty” – Philippe Grandjean, MD, Ph.D.) to get to this point, and it might not be possible to do it all over again. Connett pointed out that, more important, in the meantime millions of U.S. babies and children suffer continuing harm.
In an additional nudge to plaintiffs, the Court mentioned that if the verdict is appealed to a higher court, there is the possibility that the verdict could be thrown out, not on the evidence, but over the gray area of the standing of the plaintiffs to bring suit.
WHERE THE CASE STANDS NOW
The Court has asked the two sides to talk to each other, and come back and talk with him in July, then have a formal conference with documents in August (Ms. Carfora said EPA needed at least two months). The Court will postpone ruling on the case, as long as necessary, until alternatives have been exhausted.
SIGNIFICANCE OF THE TSCA FLUORIDE CASE
In this excerpt, a Bloomberg analyst explained the importance of Judge Chen’s decision here, and the stakes for citizen groups going forward : “The case is being watched in part for what it could portend for future efforts to regulate chemicals under the Toxic Substances Control Act, said Erik C. Baptist, a partner with Wiley Rein LLP. If the case goes to trial and a court eventually concludes that adding fluoride to drinking water poses an unreasonable risk, the health advocates will say the EPA must prohibit that use of fluoride. If that scenario plays out, other groups may see filing a petition with EPA requesting a new rule as a quicker way to get a chemical regulated or banned than the risk evaluation and risk management process laid out in the statute, said Baptist, former deputy assistant administrator for law and policy in the Office of Chemical Safety and Pollution Prevention.” – Bloomberg Environment. “Federal Judge Asked to Let Fluoride-in-Water Case Go to Trial (1) ” (11/15/2019)
“As of June 2018, a total of 60 studies have investigated the relationship between fluoride and human intelligence, and over 40 studies have investigated the relationship fluoride and learning/memory in animals. Of these investigations, 53 studies have found that elevated fluoride exposure is associated with reduced IQ in humans, while 45 animal studies have found that fluoride exposure impairs the learning and/or memory capacity of animals. The human studies, which are based on IQ examinations of over 15,000 children, provide compelling evidence that fluoride exposure during the early years of life can damage a child’s developing brain.“ – From Fluoride Action Network, Fluoride & IQ: The 65 Studies
The first U.S. Government-funded study investigating prenatal neurological damage from fluoride, Prenatal Fluoride Exposure and Cognitive Outcomes in Children at 4 and 6–12 Years of Age in Mexico (2017), finds that each 0.5 part per million (ppm) increase in a pregnant woman’s urine fluoride levels reduced her child’s IQ by 2.5 – 3 points.
The full peer-reviewed study, a 12 year analysis of data from 287 mother-child pairs, was published in the journal Environmental Health Perspectives (9/19/2017) , and is available at the U. S. National Institutes of Health (NIH) website. READ THE STUDY.
The new study is unique in approach, size, and duration, but it joins over 50 other human-based studies that find evidence of fluoride-based cognitive damage affecting IQ.
MORE about quantifying Fluoride’s potential to reduce IQ in children in Dawna Gallagher’s article explaining the 2017 Prenatal Fluoride/IQ study by Bashash et al.
Watch Michael Connett’s 2015 presentation on Fluoride and IQ Studies:
Michael Connett on Fluoride & IQ Studies (running time 26:24 min)
May 2018: Clean Water Sonoma-Marin Charitable Trust joins Fluoride Action Network (FAN) in the Moms2B campaign. Moms 2B alerts pregnant women to the most recent scientific evidence that consuming fluoride, whether from fluoride supplements, or from fluoridated water, can harm the developing brains of their unborn children. Don’t risk your child’s future. Learn more here: http://fluoridealert.org/issues/moms2b/
UPDATES: FLUORIDATION IN SONOMA & MARIN COUNTIES, OUR STATE & NATION
THE SONOMA COUNTY BOARD OF SUPERVISORS has “postponed indefinitely” any consideration of the Sonoma County Department of Health Services (DHS) proposal to fluoridate Sonoma County water through the Sonoma County Water Agency (originally an item on the Sonoma County Board of Supervisors agenda 5/19/2015, item removed before the meeting). As of the 2016 elections, a majority of Sonoma County Supervisors is on the record opposing fluoridated tap water for Sonoma County.
LOOKING AHEAD, Sonoma County residents should be reassured to know that future attempts to fluoridate water in Sonoma County will not be through the Sonoma County Water Agency (SCWA) . Even if, some day, the issue returns to the Board of Supervisors, the unanimity requirement among signers to the Sonoma County Water Agency Restructured Agreement for Water Supply cannot be met as long as the City of Cotati, the City of Sonoma, and the Valley of the Moon Water District continue their formal rejection of fluoridation. MORE ABOUT SONOMA COUNTY AND SONOMA COUNTY WATER.
PETALUMA: CHILDREN’S ORAL SURGERY RATES PLUMMET AFTER FEWER THAN TEN YEARS OF UNIVERSAL DENTAL CARE: “Through a $5,000 grant from the Rohnert Park Foundation, the Rohnert Park Health Center (RPHC) will be able to expand their school-based dental program in the Cotati Rohnert Park Unified School District this year, ensuring that all children in the community receive proper dental screenings, check-ups, preventative education, and if needed, access to restorative and emergency treatment services… [The RPHC] school dental program was first started in Petaluma less than ten years ago when the health center realized that many of the children in the community were suffering from dental diseases that are almost completely preventable. When they initially started the program they were referring about 250 children per quarter to oral surgery. The children had so many cavities that it required general anesthesia to repair them. After a few years of providing preventative care and education in the schools, that number has dropped dramatically to about four children last year [about one child per quarter] that needed to be referred to oral surgery. RPHC now hopes to obtain the same results in Cotati and Rohnert Park…” Read RP Health Center ensures all children in school district receive dental care by Stephanie Derammelaere / The Community Voice (12/21/2018).
SANTA ROSA: The Sonoma County Department of Public Health has declared a renewed focus on fluoridating the City of Santa Rosa (announced at the second annual Sonoma County Dental Health Summit, 9/25/2016), although, so far, no traction has been gained.
THE CITY OF HEALDSBURG remains fluoridated. For information and updates, visit Safe Water Healdsburg online.
NORTH MARIN WATER DISTRICT (NMWD) remains unfluoridated due to the full committment of the NMWD Board of Directors, which is grateful for Clean Water Sonoma-Marin’s successful efforts to stop attempts to fluoridate through the Sonoma County Water Agency (SCWA). 80% of NMWD water, including water for the City of Novato, is provided by SCWA.
MARIN MUNICIPAL WATER DISTRICT (MMWD) remains fluoridated. Clean Water Sonoma-Marin is holding individual meetings with Marin Municipal Water District board members. The good news is that we are talking at last, not just limited to three minute comments at MMWD Board meetings.
Marin Municipal Water District’s Cataract Falls property, safe from glyphosate defoliation thanks to the MMWD Board’s use of the Precautionary Principle.
MARIN COUNTY HEALTH & HUMAN SERVICES
Because communication is essential, Clean Water Sonoma-Marin Charitable Trust members , including medical professionals, have sharedfluoridation concerns with Grant Colfax, MD, Former Director of the Marin County Department of Health, now heading the San Francisco Department of Public Health, and with Matt Willis, MD, MPH, who now heads the Marin Counth Department of Health and Human Services.
In the fall of 2017, a cordial meeting was arranged by former North Marin Water District (NMWD) Board Member, and current Marin County Supervisor from Novato, Dennis Rodoni.
In January 2018, a second meeting was arranged by Supervisor Rodoni. Although Dr. Colfax was unable to attend, Dr. Willis met with Supervisor Rodoni, and other Marin County Clean Water advocates, Ginger Souders-Mason, Deborah Landowne, Steve Lamb, CWSM-CT Director Dawna Gallagher-Stroeh , thyroid specialist Dr. Richard Shames, MD, and Marin Municipal Water District (MMWD) Board Member, attorney Larry Bragman, who explained the current suit in Federal Court against EPA on the issue of fluoride neurotoxicity. Brian Smith DDS, and Bill Osmunson DDS, MPH, participated in the meeting via letters to Dr. Colfax and Dr. Willis.
As with all Public Health professionals, Dr. Willis is tasked with implementing and supporting Public Health policies, including water fluoridation. However, Dr. Willis said, of all the concerns about water fluoridation presented at the meeting, the one that gives him pause is the issue raised in the letter from Dr. Osmunson, the possiblilty that, with increasing fluoride exposure from many sources, Marin County residents might be receiving too much fluoride.
THE HEALTH COUNCIL OF MARIN is looking into the new data on fluoride toxicity. We have been contacted, and are providing documents as requested. The Health Council operates under Marin County Health & Human Services (HHS), and is responsible for advising the Marin Board of Supervisors, and Marin HHS on health issues, and advocating “for the development and allocation of resources to assure quality and accessible health care, and to educate regarding issues affecting the health and well-being of the citizens of Marin County.” Source: https://www.marinhhs.org/boards/marin-health-council
CALIFORNIA & THE NATION
MEDICAID FUNDS FOR FLUORIDATION INFRASTRUCTURE
Jay Kumar, DDS, MPH, is California’s first Director of Dental Health, an office created in 2015, after years of lobbying by the California Dental Association (CDA). Before coming to California, Dr. Kumar was instrumental in setting up a pilot program, now in effect in New York State, in which millions of dollars in Medicaid funds now support water fluoridation. The program, which siphons off scarce funds from effective dental and other health care, is a first step in an ambitious plan to use Medicaid funds to pay for water fluoridation infrastructure, engineering, chemicals costs, and staff time, nationwide. Dr. Kumar is in discussion with public health officials and key legislators, about a similar program for California. For more information, and documentation, please contact us.
TO BENEFIT THE NATION
VIDEO: Zero Waste hero, and FAN co-founder Dr. Paul Connett and Dr. Bill Hirzy, retired Senior Scientist for Risk Assessment at US EPA (1981-2004), old comrades-in-arms, have just hand delivered The Petition to EPA Headquarters, along with many heavy boxes of scientific documentation. Now they sit in the sun, praise young attorney Michael Connett for his brilliant work and, figuratively, pass the torch.
November 23, 2016, the International Academy of Oral Medicine & Toxicology (IAOMT), and Fluoride Action Network (FAN), in coalition with others, hand delivered a petition to US EPA, accompanied by over 2,500 pages of scientific documentation, to ban the use of fluoridation chemicals because of the neurotoxic risks of fluoride ingestion.
Historically, when a chemical has evidence of neurotoxicity, for example lead, EPA has banned its use. Since 2014, fluoride has been on EPA’s short list of chemicals, including arsenic and lead, with scientific evidence of developmental neurotoxic harm to humans. However, EPA rejected the petition (2/27/2017).
April 18, 2017, the petitioners responded by filing a complaint in US District Court in San Francisco, seeking a ban on water fluoridation, under Section 21 of the Toxic Substances Control Act (TSCA).
November 30, 2017, EPA responded with a motion to dismiss “all claims in the present matter.” The EPA motion was denied by Judge Edward M. Chen (12/21/2017). In early 2018, Judge Chen rejected an EPA brief seeking to deny plaintiffs the right to submit any evidence, including new scientific studies, not submitted at the time of the original filing.
NOTE: “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.” – attorney Michael Connett (01/15/2018)
For brief background on the petition, a detailed timeline of the lawsuit, including links to all filings and rulings to date, and the names of plaintiffs, and their attorneys, please read: Lawsuit against US EPA Regarding Fluoride Neurotoxicity.
October 22, 2018 Inside EPA reports [excerpt]: Latest EPA Defeat, Judge Orders More Discovery In TSCA Fluoride Suit. A federal judge has ordered EPA to provide internal documents and allow plaintiffs to depose agency staff on the risks posed by fluoridation, mandates that highlight the effect of an earlier ruling allowing the plaintiffs to introduce new evidence in their landmark Toxic Substances Control Act (TSCA) suit rather than limiting it to the agency’s record. In an Oct. 4 order, Judge Edward Chen, of the U.S. District Court for the Northern District of California, ordered EPA to release internal documents regarding its scientists’ views of a study linking fluoridation to IQ decrements, as well as ordering EPA to allow plaintiffs to depose agency staff on whether its existing fluoride standards consider neurotoxicity risks.
…Chen writes that the plaintiffs’ requests “are relevant because whether the EPA considered the neurotoxic risk of fluoride in establishing its safety standards bears on how much weight the Court should give to any EPA argument that its safety standards can be used to show what a safe level of fluoride is.”
…”In my view, it’s quite significant going forward … [Chen] didn’t provide any qualifications. He allowed deposition and forced EPA to search for internal documents,” the plaintiffs’ attorney, Michael Connett with Waters Kraus & Paul’s Los Angeles office, tells Inside EPA. “Even though [the order] is not technically precedential, it’s nevertheless helpful guidance for future courts” because this case is the first of its kind.”
VIDEO: Dec 31, 2019: Michael Connett gives an update on the TSCA Fluoride Lawsuit (running time 3:33).
“We are leaving no stone unturned. The court will hear the best evidence that’s available on this issue,” says Michael Connett, the pro bono attorney for the case.
On December 31, 2019, Edward M. Chen, U.S. District Judge, U.S. District Court for the Northern District of California, dismissed an EPA motion for summary judgement (MSJ) in the fluoride TSCA lawsuit. This means that our case will go forward. The trial has been rescheduled to begin Monday April 20 and will run for two weeks.
This is the first time in its 43-year history that citizens have been able to successfully bring a suit to court under the Toxic Substances Control Act (TSCA) provisions. This is a huge moment for us, and for the environmental movement as a whole. Finally the EPA is going to be held accountable for its decades of neglect with respect to protecting citizens from the deliberate addition of a known toxic (neurotoxic) substance to the public drinking water. Finally, we get our day in court, with experts from both sides presenting under oath.
Background on the case at TSCA Fluoride Lawsuit.
You can help with this historic lawsuit by making a tax deductible donation to FAN now.
UPDATE ON H.R. 2422
Lobbying Members of Congress on H.R. 2422 takes our intrepid Clean Water Sonoma-Marin team to some unexpected places in the Capitol Building, Washington DC (September 15, 2017). Photo: Merrilyn Joyce
H.R. 2422, the Action for Dental Health Act of 2018, while carefully written to avoid mentioning water fluoridation, authorizes funding programs to promote fluoridation through 2022 and will cost taxpayers 160 million dollars. Because of Sonoma County emails and calls to our Members of Congress, added to action by concerned citizens across the country, including some of us who went to Washington DC to talk with Congressmen and staff members in person, H.R. 2422 was withdrawn last year, but was reintroduced in 2018. The text, unamended since it was reported to the House on September 25, 2017, was signed into Public Law No: 115-302 on December 11, 2018. For background on H.R. 2422, see Stuart Cooper’s article in the October 2017 issue of the Sonoma County Gazette, “Take Action: Stop or Amend H.R. 2422.”