By Tony Edwards, DrBicuspid.com editor in chief

March 2, 2017 -- The U.S. Environmental Protection Agency (EPA) has denied a petition filed by the Fluoride Action Network (FAN) and others that would have prohibited the "purposeful addition of fluoridation chemicals to U.S. water supplies."

The agency denied the petition filed on November 23, 2016, because of a lack of scientific evidence about the neurotoxic harm from exposure to community water fluoridation, according to a proposed rule published in the Federal Register (February 27).

"After careful consideration, EPA denied [the petition], primarily because EPA concluded that 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.," the agency wrote.

The EPA further explained the rationale behind the denial.

"The petition cites several studies as evidence that water fluoridation does not have any demonstrable benefit to the prevention of tooth decay," the agency noted. "However, EPA has found substantial concerns with the designs of each of these studies, including small sample size and uncontrolled confounders, such as recall bias and socioeconomic status."

Prohibiting fluoride addition

Under section 21 of the Toxic Substances Control Act, any person can petition the EPA to amend or repeal one of the agency's rules. Each petition has to follow a certain process in which it sets forth the facts that are claimed to establish the necessity for the action requested, and the agency has 90 days to respond.

As published in the Federal Register, the fluoridation petition urged the agency "to protect the public and susceptible subpopulations from the neurotoxic risks of fluoride by banning the addition of fluoridation chemicals to water." The Fluoride Action Network contended that the "purposeful fluoridation of drinking water presents an unreasonable risk to human health from neurotoxicity."

9 claims

The Fluoride Action Network petition made the following nine claims, with the EPA's response following each claim.

Overall, the agency stated that the petition did not set forth sufficient facts to justify its primary claims about purported neurotoxic effect from drinking fluoridated water.

  • Claim 1: Fluoride poses neurotoxic risks to the U.S. population.

    The EPA responded that FAN's petition ignored "a number of basic data quality issues associated with the human studies it relies upon." The agency specifically referred to the human studies cited, which it said were cross-sectional in design and affected by antecedent-consequent bias.

    "The antecedent-consequent bias means it cannot be determined whether the exposure came before or after the health effects, since both are evaluated at the same time," the agency wrote.
  • Claim 2: Recent epidemiological studies corroborate the findings of neurotoxic risk in Western populations.

    The EPA noted that the petition cited two studies from Western populations to attempt to corroborate the assertion that exposure to fluoride in drinking water presents unreasonable risks for neurotoxicity. While the studies made "reasonable use of the population-level data available, causal inference cannot be made from these studies," the agency wrote.
  • Claim 3: Studies on both experimental animals and cell cultures are consistent with cited human research linking fluoride exposure with neurotoxic effects in humans.

    "Very few studies [that] assessed learning and memory effects at exposure levels near 0.7 parts per million, the recommended level for community water fluoridation in the United States," the EPA responded.
  • Claim 4: Susceptible subpopulations are at heightened risk.

    The agency stated that no support was available for the petitioner's claims from the data and information provided.
  • Claim 5: EPA's 1998 Guidelines for Neurotoxicity Risk Assessment support the need to apply a 10-fold uncertainty factor in deriving an oral reference dose (RfD) or inhalation reference concentration (RfC).

    The EPA noted that the petition did not set forth the strengths and limitations of each of the studies in the overall database of available studies nor any criteria or rationale for selecting the eight particular studies from which to derive an RfD or RfC.

    "Without setting forth the strengths and limitations associated with each study and the weight of evidence provided by the available database, a necessary step in any assessment, it is not possible to determine whether uncertainty factors are necessary," the agency wrote.
  • Claim 6: Fluoridation of drinking water confers little benefit to the public health, relative to the risk.

    The EPA responded by stating that it "does not believe that the petition has presented a well-founded basis to doubt the health benefits of fluoridating drinking water."
  • Claim 7: There is an unreasonable risk to the U.S. population that lives in areas with community water fluoridation.

    The EPA dismissed this claim, stating that FAN and other petitioners have "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."

    The agency continued, writing that the petitioners have not "set forth a scientifically defensible basis to estimate an aggregate loss of IQ points in the U.S., attributable to this use of fluoridation chemicals."
  • Claim 8: Fluoridated drinking water could be "easily and cheaply" eliminated and alternatives products with topical fluoride are widely available, therefore the risks entailed are unreasonable.

    The agency noted that the petition cited an already repealed provision of the Toxic Substances Control Act, and this ends-driven reasoning that is "forbidden" by the amended act.
  • Claim 9: Fluoridation chemicals are associated with elevated blood lead levels, and laboratory and epidemiological research links artificial fluoridation chemicals with pipe corrosion.

    The EPA rejected this statement, stating the petition was not able to present facts that supported the argument.

Opposing statements

Michael Connett, an attorney with the Fluoride Action Network and the author of the petition, stated in a release that the agency's decision was unfortunate.

"Unfortunately, the EPA's decision to deny our petition demonstrates that the Agency is not yet prepared to let go of the outdated assumptions it has long held about fluoride," Connett stated.

“It is always heartening when our government comes down on the side of sound science.”
— Gary Roberts, DDS, ADA president

The agency's decision can be challenged in federal court, he noted.

"For too long, EPA has let politics trump science on the fluoride issue," he stated. "We welcome, therefore, having these issues considered by a federal court."

However, the American Fluoridation Society and the ADA welcomed the agency's denial of the petition.

"Once again, fluoridation opponents have been caught misreading or misrepresenting the science. We applaud the EPA's response to this flawed petition," stated Johnny Johnson Jr., DMD, president of the American Fluoridation Society.

Gary Roberts, DDS, president of the ADA, concurred.

"It is always heartening when our government comes down on the side of sound science," Dr. Roberts stated. "Public health policy recommending community water fluoridation results from years of scientifically rigorous analysis of the amount of fluoride people receive from all sources.

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Copyright © 2017 DrBicuspid.com

Last Updated hh 3/1/2017 4:52:00 PM

12 comments so far ...
3/2/2017 11:02:34 AM
Seabreezes1
Bureaucratic Dodge of Political Hot Potato 
The long and short of it is that although the EPA nit-picked on complaints about several studies, they ignored most of the studies documenting harm submitted in the petition. They also failed to seek the testimony of citizen petitioners who could have provided evidence of harm consistent with neurotoxic and other health concerns cited by the 2006 NRC [National Research Council Fluoride in Drinking Water: A Scientific Review of EPA's Standards] who advised the EPA that it was reasonable to anticipate harm to vulnerable subpopulations consuming artificially fluoridated drinking water.  Not only that, the EPA did not counter with science as much as with statements of endorsements from organizations with vested interests in the proliferation of fluoridation. 
 
Moreover, EPA refused to consider the impact of fluoridation on infrastructure and corresponding increases in blood lead levels in children, as well as dismissing other concerns based on bureaucratic details rather than merits of those scientific facts in evidence. Most egregious, they claim they need more information on all health endpoints and details for all uses of fluoridation chemicals and all types of fluoridation chemicals before they could invoke TSCA rule making. The 2006 NRC panelists provided the EPA with multiple health endpoints including renal, endocrine and gastrointestinal disease, as well as neurotoxicity and cancer. The EPA has failed to undertake those studies, while communities and regulatory agencies continue to lump together all types of industrially created fluoridation chemicals as “safe” based on supposed observations of a small population one hundred years ago who were consuming calcium fluoride, and the controversial 1940s trials using sodium fluoride. 90% of communities use some type of fluosilicic acid compound for their fluoridation chemical, industrial waste collected in pollution scrubbers and known to be contaminated with many poisons including arsenic. 
 
This EPA response is not unexpected. Fluoridation is a 72 year old business, and money is being made or saved based on that business model, even within the government. Fluoridation policy-making legally belongs to municipalities and states, and EPA would rather stand clear of the fray. The scientists who authored the 2000 York Review, like the scientists who authored the 2015 Cochrane Review, found pro-fluoridation science to be very low quality and highly biased. [Water fluoridation for the prevention of dental caries, A systematic review of existing research by Cochrane Oral Health Group, June 2015;  York Review of Public Water Fluoridation. Sept 2000]  
 
The 2000 York scientists went on record in 2007 stating that the results of their report have been misrepresented to the public in overly optimistic terms in order to justify fluoridation and that it is not the purview of scientists to recommend policy. These scientists said that public health decisions should be made with consideration of ethics by those in government. [Cheng KK, Chalmers I, Sheldon TA. Adding fluoride to water supplies. BMJ : British Medical Journal. 2007.] Ethically, it is immoral to mass prescribe a medication to be distributed through the water system because it not only violates the doctrine of Informed Consent as stated in the Nuremberg Code in the 20th century and in UNESCO documents on Bioethics in the 21st century, but also because it is contrary to modern principles of pharmacology that emphasize individual dose control.  
 

3/2/2017 11:17:36 AM
John OZ
Double Standards?
What if we turn this around 180 degrees, and ask the EPA, can they provide substantial studies to prove the effectiveness and safety of supplying fluoride to the public in the water plus the many other sources of fluoride, with the designs of each of these studies, including large sample size and controlled for confounders, such as recall bias and socioeconomic status?
 
The Cochrane Collaboration, in 2015, could not find many studies, since 1975, meeting high standards of proof.
And they found zero studies proving effectiveness for adults, and 12% of children may be harmed.
http://www.cochrane.org/C...on-prevent-tooth-decay
 
"Within the ‘before and after’ studies we were looking for, we did not find any on the benefits of fluoridated water for adults.
We found insufficient information about the effects of stopping water fluoridation.
We found insufficient information to determine whether fluoridation reduces differences in tooth decay levels between children from poorer and more affluent backgrounds.
Overall, the results of the studies reviewed suggest that, where the fluoride level in water is 0.7 ppm, there is a chance of around 12% of people having dental fluorosis that may cause concern about how their teeth look."
 
 
'
 

3/2/2017 3:30:33 PM
Dr.JohnnyJohnson
Kudos to the EPA for scientifically and critically evaluating the claims brought before them, once again. Only this time a different division was tried to see if the community water fluoridation (CWF) opponents could squeak out something positive from their work.
 
Once again, credibly conducted science is what we have to rely on.  The lack of a single adverse health effect from optimally fluoridated water in over the 72 years of CWF in the U.S. is clear.  There is no harm.
 
Systematic reviews which look at the current literature on CWF's effectiveness and safety, continue to show that CWF reduces cavities by at least 25% above and beyond those already reduced from topical fluorides, eg toothpaste, mouthrinses, varnishes.
 
As a clinical pediatric dentist with 30 years of experience, I can attest to the benefits of CWF to my patients.  Examining a patient at their first visit, without even looking at their past demographic history, reveals the state of the health of their teeth.  Without a doubt, CWF reduces both the number and severity of cavities in adults and children.
 
Thank you for a fantastic article Mr. Edwards.  You nicely summarized the findings of the EPA review.  
 
Regards,
Johnny Johnson, Jr., DMD, MS
Pediatric Dentist
Diplomate American Board of Pediatric Dentistry
President, American Fluoridation Society

3/2/2017 3:40:52 PM
Steveslott
This is the second petition to the EPA filed within the past 3 years by personnel of the New York antifluoridationist faction, "FAN". Each one has been met with an embarrassing rejection. These detailed rejections were based on facts and evidence which should have been properly researched by these activists before filing their petitions, instead of their filing slip-shod conglomerations of ridiculous claims requiring the EPA to waste valuable time and resources in explaining the blatantly clear flaws in their reasoning, and the faulty evidence on which they relied.

In the first, filed in 2014, by "FAN" paid lobbyist, William Hirzy, EPA reviewers quickly discovered a 70-fold error in Hirzy's calculation of the data on which he relied. When corrected for the error, the reviewers demonstrated that the data showed exactly the opposite of what Hirzy had claimed. Obviously, the petition was rejected.

Now, in this one, EPA reviewers systematically demonstrated the flaws and irrelevance of the studies presented by the petitioners, as well as the misrepresentation of study results by the petitioners. Obviously, the petition was rejected.

The reaction of the antifluoridationists and their groups clearly shows that opposition to fluoridation is not based on science, facts, or evidence. It is based on the same, skewed personal ideology against fluoridation which has existed since the ultra-conservative John Birch Society at the very beginning of the initiative, 72 years ago. As can be noted by comments on this page, it makes no difference how much science, how many facts, or how much evidence is presented to them, antifluoridationists will always reject it. When their arguments have all been refuted, they simply fall back on the stale, old claims of conspiracy and corruption, and keep right on going.

If the antifluoridationists choose to waste even more taxpayer funds by appealing this decision, the result will be same. The appeal will be rejected for lack of valid supporting evidence, and the antifluoridationists will refuse to accept the decision, based on their usual claims of corruption and conspiracy. They will keep right on with their campaigns of misinformation, undeterred one iota.

How much more of our tax dollars must be wasted in answering these poorly-researched, frivolous, petitions filed by these people who have nothing better to do?

Steven D. Slott, DDS
Communications Officer
American Fluoridation Society

3/2/2017 3:52:48 PM
Dr.JohnnyJohnson
You would do yourself a true service to read the Plain Language Summary of the Cochrane Oral Health Group report on CWF.  
This group was tasked with updating the York review from 2000.  Their methodology was the same.  They applied methodology that is used to evaluate medical therapy, not public health interventions.  They have both protocols in existence.  However, since they were updating a 15 year old study, they had to use the same protocol.
 
Their inclusion criteria for studies was so narrowly defined that very few studies after 1974 met their criteria.  That was no surprise.  It is akin to looking at the effectiveness of Penicillin in 2015 and trying to find studies that evaluated its effect before and after its use in two different groups.  Would we deny one group the benefits of Penicillin in today's world while giving it to another just to fulfill a research project?   Of course not.  That would not only be morally and ethically wrong, it would constitute malpractice.  Instead, today's studies look for a better mousetrap, a better antibiotic compared with those currently in use.
 
The benefits of CWF are well known and the safety well established.  Current studies constantly evaluate the effect of CWF on populations served to determine the reductions in cavities in this age of products produced in fluoridated areas, but consumed in non-fluoridated areas.  They also evaluate communities that would meet the Cochrane strict inclusion criteria where confounding factors and equal SES strata can be met between two similar communities, one non-fluoridated, and the other newly fluoridated.
 
Johnny