Tag Archives: EPA

EPA comprehensively debunks anti-fluoride claims of a fluoride-IQ effect

FAN propaganda video promoting their petition to the EPA to stop community water fluoridation

The US environmental Protection Agency (EPA) has denied an anti-fluoride petition to ban community water fluoridation. The document outlining its reasons for declining the petition is valuable because it considers all the arguments and evidence presented in the petition and comprehensively shows them to be misleading or even false.

This is a humiliating defeat for the petitioners – the US  Fluoride Action Network (FAN), Food & Water Watch, Organic Consumers Association, American Academy of Environmental Medicine, International Academy of Oral Medicine and Toxicology and Moms Against Fluoridation. FAN, and in particular Michael Connett, had put a lot of work into their petition. The petition is a 76-page document, heavily referenced and, importantly, presenting all the best arguments that FAN could find. FAN did not keep any of their powder dry.

Of course, FAN and their associated international groups, Facebook pages and websites heavily promoted this petition. They had high hopes – Paul Connett himself has argued that their evidence would bring about the complete demise of community water fluoridation within a few years. The local Fluoride Free NZ issued a press release with the heading EPA Petition Could Spell End of Fluoridation claiming “FAN’s assessment provides unequivocal proof that current allowable levels of fluoride are not protective for all members of the population from damage to the brain.” Mary Byrne, their spokesperson asserted:

“Fluoridation belongs to a by-gone era and far too much is now known about adverse health effects for any further consideration on fluoridation to be seriously considered.”

Many anti-fluoridation submissions to the Parliament Health Committee considering changes to fluoridation legislation in New Zealand have relied strongly on the FAN petition – presenting it as the best thing since sliced bread.

Serious consideration

The EPA did give the petitioners arguments serious consideration – as we should expect from such an authoritative organisation. The petition was not rejected out of hand – the EPA’s 50-page document eexaminesthem in detail.

This is what makes the EPA document so available – it considers all the FAN arguments, the scientific papers presented and the evidence claimed. It shows how many of these papers and claimed evidence are misrepresented by the petitioners. It points to the limitations of the studies FAN relies on. It shows how FAN has not even established a case for reconsideration of recommended safe levels for fluoride and explains that the methodology used by FAN, and the recent publication by FAN staff (Herzy et al., 2016 – see Debunking a “classic” fluoride-IQ paper by leading anti-fluoride propagandists), is not valid.

The documents overall assessment of the petition’s arguments is damning:

“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. Still less has the petition 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. As noted previously, EPA has determined the petition did not establish that fluoridation chemicals present an unreasonable risk of injury to health or the environment, arising from these chemical substances’ use to fluoridate drinking water “

Some specific rejections

The petition argued about 12 points and the EPA responded to all of them. Here are a few extracts.

The central claim of the anti-fluoride petitioners is that  Fluoride is neurotoxic at levels relevant to U.S. population. It cited human studies to support this but the EPA document responded by pointing out “the petition ignores a number of basic data quality issues associated with the human studies it relies upon.”

A central problem is the lack of  consideration of other factors possibly involved in influencing IQ – confounders:

“The petition . . .  does not properly account for the relatively poor quality of the exposure and effects data in the cited human studies (e.g., it appears to give all studies equivalent weight, regardless of their quality). When an association is suggested between an exposure and a disease outcome, the studies need to be assessed to determine whether the effect is truly because of exposure or if alternate explanations are possible. The way to do that is to adjust for potential confounders, such as diet, behavior, and socioeconomic status, in order to appropriately assess the real relationship between the exposures to a specific substance and health effects. In other words, when these confounding factors are potentially present, but not recognized or controlled for, it is not possible to attribute effects to the contaminant of concern (fluoride) as opposed to other factors or exposures. The evidence presented did not enable EPA to determine whether various confounding factors (e.g., nutritional deficiencies) were indeed placing particular subpopulations at a “heightened risk of fluoride .”

The issue of confounders is central to the petitioners claim that recent epidemiological studies corroborate neurotoxic risk in Western populations. The petition cites two studies from Western populations to attempt to corroborate the assertion that exposure to fluoridated water presents unreasonable risks for neurotoxicity. I have discussed these in previous posts – Peckham et al (2015) which claim to show that hypothyroidism is related to fluoridation and Malin & Till (2015) which demonstrated a relationship of ADHD prevalence to extent of fluoridation.

The EPA response says of the Peckham et al (2015) paper that:

“Adjustment for some confounders was considered, including sex and age, but other potential confounders (such as iodine intake) were not assessed. Fluoride from other sources and other factors associated with hypothyroidism were not assessed in this study.”

Iodine deficiency is a well-known factor in hypothyroidism.

The EPA response was relatively kind in its comment on the Malin & Till study:

“Although it is possible that there may be biological plausibility for the hypothesis that water fluoridation may be associated with ADHD, this single epidemiological study is not sufficient to “corroborate” neurotoxic health effects, as stated in the petition. More study would be needed to develop a body of information adequate.”

I showed in my article ADHD linked to elevation not fluoridation that once factors like elevation, poverty, and house ownership were included there was no statically significant relationship between ADHD prevalence and the extent of fluoridation in Malin & Till’s data. That is a clear example how conclusions based on correlations can be completely wrong when confounders are not properly considered.

The petitioners fell back onto their claim that neurotoxic risks of fluoride are supported by animal and cell studies – a common anti-fluoride tactic. However, the EPA document responded by pointing out that the petitioners had misrepresented such studies. It pointed out that these studies had been recently reviewed by the US National Toxicity Program (NTP) and the petitioner’s misrepresentation of the studies:

“do not change EPA’s agreement with the conclusions of the NTP report that their “[r]esults show low-to-moderate level-of-evidence in developmental and adult exposure studies for a pattern of findings suggestive of an effect on learning and memory.”

The petitioners claim susceptible subpopulations at heightened risk from CWF is a common claim of anti-fluoride propagandists. The EPA found this argument unconvincing:

“The data and information provided in the petition do not support the claims that “nutritional status, age, genetics and disease are known to influence an individual’s susceptibility to chronic fluoride toxicity.”

The petition argued there were no established benefits of CWF to public health. The EPA responded by outlining some of the evidence for CWF benefiting oral health and responded to the petitioners claims with:

EPA does not believe that the petition has presented a well-founded basis to doubt the health benefits of fluoridating drinking water.

Despite not showing that community water fluoridation is linked to IQ losses the petitioners asked that because fluoridation covers a large population any harm would affect a large number of people so drinkign water fluoridation should be stopped on those grounds alone. Incidentally, Hirzy et al (2016) promised a future paper where they estimate economic losses to the USA because of fluoridation. I guess they will just ignore the Swedish work that actually shows drinking water fluoride levels are positively related to increased income and chances of employment (see Large Swedish study finds no effect of fluoride on IQ).

The EPA response to this argument:

As noted previously, EPA has determined the petition did not establish that fluoridation chemicals present an unreasonable risk of injury to health or the environment, arising from these chemical substances’ use to fluoridate drinking water. The fact that a purported risk relates to a large population is not a basis to relax otherwise applicable scientific standards in evaluating the evidence of that purported risk.

I like that bit about “relaxing scientific standards.” Doesn’t it just describe the whole approach of the anti-fluoride propagandists to the science?

What now?

According to the rejection letter the Petitioners, the Fluoride Action Network and their ideological mates can appeal the declining of their petition:

“by commencing a civil action in a U.S. district court to compel initiation of the requested rulemaking proceeding within 60 days of the date of this denial letter.”

The letter was dated February 17 – so they have until mid-April to get this underway. Michael Connett – who did the heavy lifting in the preparation of this 76-page petition – is an attorney so may be more capable with such legal action than he appears to be with the scientific arguments.

fluoride-theology

At the moment anti-fluoride propagandists appear more concerned with the theological questions related to leprechauns than they are with the EPA’s rejection of their petition.

At the moment the anti-fluoride groups, including those in New Zealand, are silent. It’s as if they did not receive their rejection letter almost 10 days ago. Perhaps they are busy debating their possibilities – and the public stance on this rejection they will eventually have to take.

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Anti-fluoridation study flawed – petition rejected

A recent research paper claiming a signficant cost/benefit advantage in banning the use of fluorosilicic acid as a fluoridating agent in public water treatment, and replacing it with sodium fluoride, has been found flawed. This was revealed as a result of the rejection by the US Environmental protection Agency (EPA) of a petition by the author

dr-william-hirzy-phd-370x277

Dr William Hirzy testifies for an anti-fluoridation group

The original paper by Hirzy et al. (2013) is on-line – full details are Hirzy, J.W., Carton, R.J., Bonanni, C.D., Montanero, C.M., Nagle, M.F. (2013) Comparison of hydrofluorosilicic acid and pharmaceutical sodium fluoride as fluoridating agents—A cost–benefit analysis  J Environmental Science and Policy Volume 29, May 2013, Pages 81–86.

Briefly the authors had used data (arsenic (As) concentrations in a number of samples of fluorosilicic acid and sodium fluoride) and a model for the predicted incidence of cancers resulting from As contamination in water supplies. Their cost/benefit analysis claimed “the U.S. could save $1 billion to more than $5 billion/year” by using pharmaceutical grade sodium fluoride instead of fluorosilicic acid.

Consequently Hirzy petitioned the EPA to ban use of fluorosilicic acid, using his study as supporting evidence. The EPA responded officially on August 6 and, despite some of the legalese, their notice is worth reading for anyone interested in the fluoridation controversy.

A calculation error for arsenic

When I first read Hirzy’s paper I was concerned that the quoted values for As in the fluorosilicic acid samples he considered were higher than found in New Zealand. (As concentrations in local fluorosilicic acid for water treatment are about the same as for the pharmaceutical garde sodium fluoride he used). I wondered if his data was out of date, or he had used commercial grade samples and not water treatment samples. However, the EPA found a more basic fault – Hirzy’s calculations were wrong! They had “failed to convert their estimates of lifetime cancer risk to estimates of annual cancer risk for the purpose of calculating annual net benefits.” When corrected the cost benefit analysis favoured fluorosilicic acid “(-$81M/year to -$8M/year, respectively) rather than pharmaceutical grade NaF over HFSA:”

1. Arsenic. EPA evaluated the cost-benefit analysis submitted by the petitioners and determined that the petitioners miscalculated net benefits for pharmaceutical grade NaF compared to HFSA. Specifically, it appears that the petitioners failed to convert their estimates of lifetime cancer risk to estimates of annual cancer risk for the purpose of calculating annual net benefits. This error alone results in a 70-fold overestimation of the number of annual cancer cases due to arsenic. That is, for the analysis in which the petitioners evaluate arsenic concentrations of 0.078 parts per billion (ppb) due to HFSA and 0.00084 ppb due to pharmaceutical grade NaF, the estimated numbers of cancer cases, when corrected, decrease from 320 to 4.6 per year for HFSA and from 3.4 to 0.05 per year for pharmaceutical grade NaF (Refs. 2 and 9). Similarly, for the analysis in which the petitioners evaluate an arsenic concentration of 0.43 ppb due to HFSA and 0.00084 due to pharmaceutical grade NaF, the estimated numbers of cancer cases,  when 8 corrected, decrease from 1,800 to 25 per year for HFSA and from 3.4 to 0.05 per year for pharmaceutical grade NaF (Refs. 2 and 9). After making the correction (i.e., annualizing the lifetime cancer risk), and retaining all other assumptions of the petitioners analysis, the analysis actually indicates that the cost-benefit ratio is in favor of using HFSA over pharmaceutical grade NaF (-$81M/year to -$8M/year, respectively) rather than pharmaceutical grade NaF over HFSA (Ref. 9). As a result, the information submitted by petitioners does not support the petitioners’ claim that there are net benefits in switching from HFSA to pharmaceutical grade NaF. Given that the petition is based upon the premise that the benefits of using pharmaceutical grade NaF as a fluoridation agent significantly exceed the costs relative to the use of HFSA as a fluoridation agent, EPA concludes that petitioners have not set forth sufficient facts to establish that HFSA presents or will present an unreasonable risk of injury to health or the environment with respect to arsenic or that it is necessary to initiate a TSCA section 6(a) rulemaking to protect adequately against such risk.

Lead risk not proved

The EPA similarly found that Hirzy’s claim that fluorosilicic acid caused leaching of lead from pipes in the water supply system was similarly unproved”

2. Lead. Petitioners assert that HFSA contains lead but provided no data to support this assertion. Petitioners also assert that the use of HFSA in lead-containing water piping systems results in leaching of lead from lead-containing water piping systems into water (Ref. 5), and that when chloramine is used in conjunction with silicofluorides greatly enhanced leaching of lead into water occurs (Ref. 3). . . . .  Based on the available evidence, EPA cannot conclude that the use of HFSA, with or without the presence of chloramine, results in enhanced leaching of lead.

Radioactive contaminants

Again the EPA found that Hirzy’s claims about radionuclide contamination were not supported:

4. Radionuclides. Although the petitioners mention “concern” about radionuclides, the petitioners present limited information to support a claim that HFSA presents or will present and unreasonable risk with respect to radionuclides. NSF compiled data from initial and annual monitoring tests for fluoridation products that NSF certified to NSF/ANSI 60 between 2007 and 2011 (216 samples) and between 2000 and 2006 (245 samples). Alpha emitters (type of radioactive decay in which an atomic nucleus emits an alpha particle) were detected in less than 1% of the 216 samples analyzed between 2007 and 2011. The mean (non-detects were estimated at ½ the detection limit) and maximum values were less than the MCL of 15 picoCuries per liter (pCi/L) and were less than the NSF/ANSI 60 SPAC of 1.5 pCi/L (Ref. 15). Beta photon emitters (another type of radioactive decay in which an atomic nucleus emits a beta particle) also were detected in less than 1% of the 216 samples analyzed between 2007 and 2011. The mean (non-detects were estimated at ½ the detection limit) and maximum values were less than the MCL of 4 millirems per year (mrem/y) and were less than the NSF/ANSI 60 SPAC of 0.4 mrem/y (Ref. 15). Radionuclides (alpha or beta) were not detected in any (0%) of the 245 samples analyzed between 2000 and 2006 (Ref. 11). The concentrations reported represent contaminant levels expected when the fluoridation products are dosed into water at the allowable maximum use levels for NSF/ANSI 60- 2012 (see Refs. 14 and 15). NSF notes that lower product use levels would produce proportionately lower contaminant concentrations. Thus, the petition has failed to present facts that establish that HFSA presents or will present an unreasonable risk of injury to health or the environment with respect to radionuclides, or that it is necessary to issue a TSCA section 6 rulemaking to protect health and the environment from such risk.

So, it would be nice if anti-fluoridationists would stop using Hirzy’s paper to “prove” that use of fluorosilicic acid causes cancer when used as a fluoridating agent. Or better still, stop promoting the lie that such fluoridating agents contaminate our drinking water with toxic heavy metals and radioactive elements.

But, going by past practice I am not going to hold my breath.

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