F.A.N. Newsletter

 National Toxicology Program (NTP): Cowed by dental interests?

Unprecedented move by NTP to issue incomplete report that lacks neurotoxicity hazard conclusions

After almost five years of effort by a half dozen NTP staff and almost 50 contract specialists that involved identifying and sifting through hundreds of studies about fluoride neurotoxicity, the NTP has suddenly announced they will no longer complete the task they set out to do.

From the beginning of this long process the primary goal has been clear– to reach an “NTP hazard identification conclusion”:

“The overall objective of this evaluation is to undertake a systematic review to develop NTP hazard identification conclusions on the association between exposure to fluoride and neurodevelopmental and cognitive effects ....” [NTP 2020, p 4]

On February 22, 2021, FAN learned of a brief statement that reveals that NTP, instead of reaching a hazard conclusion, will issue a “state of the science report”.  Hidden behind the term “state of the science report” is the real intent, which was revealed to a reporter from the news service InsideEPA.  An unnamed NTP source admitted that the final “state of the science report” would not include any hazard conclusion.  FAN only learned of this statement from an attachment to a motion EPA’s lawyers filed in the TSCA lawsuit.  The statement itself is dated February 9, 2021.

Serious questions raised

For a statement that has the potential to influence a federal lawsuit and regulations to protect children from damaged brains, the way this was handled raises serious questions.  Here are some questions for which we have been seeking clear answers:

• How come the statement was not made available on the NIEHS or NTP website on February 9, 2021, or any day since?  (NIEHS is The National Institute of Environmental Health Sciences and NTP is a division of NIEHS.)

• Who at the NTP or NIEHS authored the statement?

• Who else at NTP or NIEHS knew of the statement before it was issued?

• Why was no scientific rationale or documentation provided to explain this major change?  Instead of any reason offered for the change, the statement makes a claim about dental benefits which was never part of the NTP's stated objectives.

• How did the EPA get a copy of this statement?

• What, if any, conversations took place between the NTP and the EPA or any other party (CDC, NIH, DHHS, FDA, NASEM, ADA) before this statement was released?

• Why was there no public comment or consultation, and no notice to FAN despite FAN being the original nominator of fluoride for NTP review and a key stakeholder?

• How did a false claim about the NASEM report get into the NTP statement?  The February 9 statement incorrectly says the NASEM peer review did not support the NTP conclusion of presumed hazard.  In truth, the NASEM committee never said they did not support the NTP conclusions.  What NASEM really said was that they wanted NTP to more clearly and transparently explain how they reached their conclusions.

If there were no irregular or illegitimate pressure put on the NTP to alter the goal of its monograph then these questions should be easy to answer.  If no answers are forthcoming FAN believes that there needs to be a full public enquiry into this matter.

Will the NTP’s change affect the TSCA lawsuit?

FAN doesn’t believe that NTP’s alteration of its monograph will have a major impact on the TSCA lawsuit.  Ironically, by removing all hazard conclusions NTP might even help our case because NTP’s report would then provide a clean slate for the science to be evaluated on its own, without filtering or subjectivity.

In particular, NTP’s untenable claim that at exposures below 1.5 mg/L the evidence is “inconsistent” and “unclear” will be eliminated.  It was always an absurd claim that was easily refuted by NTP’s own evidence.  NASEM castigated NTP for making these claims without any rigorous dose-response assessment to back them up.  FAN has demonstrated that with NTP’s own data, the high-quality studies finding loss of IQ at exposures below 1.5 mg/L are just as consistent and numerous as those above 1.5 mg/L.  Over 90% of the low-dose studies found loss of IQ.

As far as the argument about hazard at any level is concerned, the judge made it clear during the June 2020 trial phase, that there was no doubt that fluoride presented a neurotoxic hazard at some level.  He told the EPA lawyers:

“I’m letting you know in my mind the critical question to me -- I don’t think it’s much disputed that fluoride can be a hazard.  I don't think anybody disputes that.  At some level it’s a hazard, a neurological hazard.”

“The question ultimately is this one: At the community water fluoridation levels at the .7, or around there, and given the way it’s used and exposed and consumed by bottle, et cetera, et cetera, does it present an unreasonable risk?  ...  that’s the critical question to me.” [TSCA trial, June 17, 2021]

The judge’s “critical question” was never going to be answered by an overall hazard conclusion from NTP that did not adequately consider dose.  This is a case of “the dose makes the poison”, as Paracelsus first stated centuries ago.  High quality studies reviewed by NTP fully support a conclusion that the doses from artificial water fluoridation can cause loss of IQ.

Another fundamental principle in toxicology is that you must apply a safety factor to the level found to cause harm in a study that used a limited sample of people (or animals).  That’s because there is a large variation in individual susceptibility and exposures to any toxic agent.  A safe level must protect not just the average person, but also the most vulnerable subgroup.  A minimum safety factor of 10x is standard, which means even if there were only studies showing harm at 1.5 mg/L and higher, a level low enough to protect the most vulnerable would need to be ten times lower, or 0.15 mg/L.  That is well below the common artificial water fluoridation level of 0.7 mg/L.

There is also a more direct way of estimating the lowest exposure levels causing harm, called the Benchmark Dose method, or BMD method.  The judge in the case specifically asked that the BMD method be applied to the highest quality studies to help him decide whether water fluoridation at 0.7 mg/L posed an unreasonable risk of harm to any subpopulation.

FAN’s expert witnesses in the lawsuit were able to do exactly what the judge requested and found that the strongest studies, when pooled, demonstrate an unacceptable loss of IQ exists down to about 0.2 mg/L [Grandjean et al 2020 preprint].  So, whether one uses the default 10x safety factor or a rigorous BMD analysis, the scientific evidence supports a conclusion that fluoride exposures well below the levels found in fluoridated water are likely causing neurological harm in some children.

The next step in the lawsuit is a hearing on April 22, at which the admissibility of the NTP monograph will likely be discussed.

The public is STILL not being warned by US Health agencies

Meanwhile, no U.S.  government health agency – at any level – is warning the public that U.S. government-funded studies have provided very strong evidence that fluoridation may pose a risk to the mental development of the next generation of America’s children.

It is vital that pregnant women and parents/carers who formula-feed infants be warned of fluoride’s serious risks to the developing brain.  Pregnant women and infants should not be consuming fluoridated water.  Numerous experts in the field of developmental neurotoxicity have equated the loss of IQ from fluoridation to that from childhood lead poisoning.  They include Bruce Lanphear MD, MPH, Christine Till PhD, and Linda Birnbaum PhD, the former director of NIEHS and NTP.  Read their Op-ed: It is time to protect kids’ developing brains from fluoride.

We urge our supporters to get this warning into the hands of any scientist, doctor, public health official, educator, media outlet or legislator (at any level) they know.  No task deserves a higher priority than this.

Loss of IQ has lifelong consequences for the individual, and a profound effect on the social and economic wellbeing of the nation.  A shift downwards of 5 IQ points would halve the number of gifted children (IQ > 130) and increase by nearly 60% the number of children who may require special services (IQ < 70).  The former would decrease our effectiveness to compete in a global economy and the latter would stretch our already over-burdened social services.

As far as equity is concerned, the last thing that children from low-income homes need right now is another factor which would impact their mental development.