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United States |
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New Zealand |
| Background |
A change in law in 2016 allowed citizens in the US to petition the US EPA and then apply for a judicial review of a denial of a petition. Food and Water Watch (Including Fluoride Action Network) v the US EPA was the first action taken by a citizen group. |
| New Health New Zealand is currently taking the Director General of Health to court over the legality of the D-G’s directives, on grounds including lack of safety, lack of (cost) effectiveness of fluoridation, and that fluoridation is not a justifiable limitation on the right to refused medical treatment under section 11 of the NZ Bill of Rights Act 1990. |
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| Unsafe |
p. 2: the Court finds that fluoridation of water at 0.7 milligrams per liter (“mg/L”) – the level presently
considered “optimal” in the United States – poses an unreasonable risk of reduced IQ in children. |
| New Zealand fluoridates at 0.7 – 1 mg/L with a target of at
least 0.8ppm. The level of fluoride in the water also “poses an unreasonable
risk of reduced IQ of children”. |
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| Exposure |
p 5: The pooled benchmark dose analysis concluded that a 1-point drop in IQ of a child is to be expected for each 0.28 mg/L of fluoride in a pregnant mother’s urine. This is highly concerning, because maternal urinary fluoride levels for pregnant mothers in the United States range from 0.8 mg/L at the median and 1.89 mg/L depending upon the degree of exposure. Not only is there an insufficient margin between the hazard level and these exposure levels, for many, the exposure levels exceed the hazard level of 0.28 mg/L.
• See Point of Departure meme below. The EPA claimed that they couldn’t determine the right PoD, but even if they used 1.5 ppm as a PoD, using a single factor of ten for the Uncertainty Factor for determining a “safe” concentration would result in a MCL of 0.15 ppm. |
| This same exposure applies to New Zealand. New Zealand has a higher level of fluoridation 0.8ppm (0.7 -1ppm) than the US at 0.7ppm. The US lowered its recommended level from a range of 0.7 – 1.2ppm in April 2015. When FFNZ advised the Ministry of Health of the reduction in target they stated that they would not reduce the range from 0.7 – 1ppm.
Brough et al. found a median concentration of 0.82 (0.62, 1.03) mg/L urine Fluoride levels of mothers in Palmerston North). |
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| Risk |
p. 77: The scientific literature in the record provides a high level of certainty that a hazard is present; fluoride is associated with reduced IQ. There are uncertainties presented by the underlying data regarding the appropriate point of departure and exposure level to utilize in this risk evaluation. But those uncertainties do not undermine the finding of an unreasonable risk; in every scenario utilizing any of the various possible points of departures, exposure levels and metrics, a risk is present in view of the applicable uncertainty factors that apply. |
| This same risk applies to New Zealand. New Zealand has a higher level of fluoridation 0.8ppm (0.7 -1ppm) than the US target of 0.7ppm.
This same certainty applies to New Zealand. New Zealand has a higher level of fluoridation 0.8ppm (0.7 -1ppm) than the US target of 0.7ppm. |
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| Certainty |
p. 78: There is significant certainty in the data set regarding the association between fluoride and reduced IQ. Namely, there is a robust body of evidence finding a statistically significant adverse association between fluoride and IQ. A large majority of the 72 epidemiological studies assessed by the NTP Monograph observed this relationship including all but one of the 19 high-quality studies, see ¶¶ 34-36, and literature published after the NTP Monograph cutoff date observed the same relationship, see ¶ 37 – and countervailing evidence, for various reasons described previously, are of little impact on this repeated, and consistently observed association between fluoride and reduced IQ, see ¶ 39. Moreover, complete consistency amongst studies is not expected. See Dkt. No. 414, Feb. 9, 20240, Trial Tr. at 1172:23-1173:6 (Savitz). Notably, notwithstanding inherent difficulties in observing this association at lower exposure levels, studies assessing such levels still observed a statistically significant relationship between fluoride and reduced IQ. See ¶¶ 42-44. Again, to put the breadth of evidence supporting this finding in perspective, the EPA has identified a LOAEL based upon far less in other contexts. For instance, in the EPA’s risk evaluation of Methylene, conducted pursuant to Amended TSCA, the EPA used a LOAEL for developmental neurotoxicity, derived from the analysis of one study conducted upon mouse pups (Fredriksson et al., 1992). See Methylene Risk Evaluation at 262. Compare this with 6 (water fluoride) and 9 (urinary fluoride), high-quality, epidemiological studies of human populations underling the 4 mg/L LOAEL underlying the POD here. Dkt. No. 431-2, Trial Ex. 68 at 39, 41 (eTable 4). The scientific literature in the record provides a high level of certainty that a hazard is present; fluoride is associated with reduced IQ. The qualitative evidence is superior. |
| This same certainty applies to New Zealand. New Zealand has a higher level of fluoridation 0.8ppm (0.7 -1ppm) than the US target of 0.7ppm. |
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Vulnerable Population |
p.76: The size of the affected population is vast. Approximately 200 million Americans have fluoride intentionally added to their drinking water at a concentration of 0.7 mg/L. See Dkt. No. 421 at 206-07 (undisputed). Other Americans are indirectly exposed to fluoridated water through consumption of commercial beverages and food manufactured with fluoridated water. |
| The size of the affected population in New Zealand is also large, approximately 50 – 52% of New Zealand’s population is exposed to fluoridated water. As at June 2024, New Zealand’s estimated total population is 5.339M. 50% of that total is 2.670M. Like Americans, other New Zealanders are indirectly exposed to fluoridated water through consumption of commercial beverages and food manufactured with fluoridated water. |
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| Susceptible Population |
p. 76: Approximately two million pregnant women, and over 300,000 exclusively formula- fed babies are exposed to fluoridated water. The number of pregnant women and formula-fed babies alone who are exposed to water fluoridation each year exceeds entire populations exposed to conditions of use for which EPA has found unreasonable risk; the EPA has found risks unreasonable where the population impacted was less than 500 people. |
| The approximate number of pregnant women in New Zealand is 57,000 based on the live births in NZ in 2023 (56,955). (This was a quick estimate without averaging so it may be lower). If we assume 50% were born in fluoridated areas, then 28,478.
Infant formula numbers are difficult to estimate because they vary between socio-economic, racial. We estimate 35% of Māori and Pasifika babies are bottle fed by 3 months old and 25% of other babies. 50% for remaining babies not Māori and Pasifika.
If we took a range of between 25 – 50% we get a range of 7,000 – 14,000 infant formula fed.
See this article on breast feeding rates for estimates. |
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| Ruling |
Plaintiffs have proven, by a preponderance of the evidence, that water fluoridation at the level of 0.7 mg/L – the prescribed optimal level of fluoridation in the United States – presents an “unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation under the conditions of use.”
The Court thus orders the Administrator to initiate rulemaking pursuant to Subsection 6(a) of TSCA. See id. §§ 2605(a), 2620(a). |
| The US Federal Court obviously has no jurisdiction in New Zealand however, the science directly relates. |
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Direction |
The ruling did not specify exactly what measures must be adopted by the EPA, but under the Toxic Substances Control Act (TSCA), once the court rules that a chemical poses an unreasonable risk, the EPA is obligated by law to restrict or eliminate the risk.
Judge Chen described a range of options for regulating fluoridation, including banning it, but he warned, “One thing the EPA cannot do, however, in the face of this Court’s finding, is to ignore that risk.“ |
| The US Federal Court has no jurisdiction in New Zealand, but we expect the ruling to be appropriate to New Zealand given that the science is applicable to all fluoridated areas. |
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| NTP Finding |
The finding of the NTP report concluded that “with moderate confidence, that higher estimated fluoride exposures (e.g., as in approximations of exposure such as drinking water fluoride concentrations that exceed the World Health Organization Guidelines for Drinking-water Quality of 1.5 mg/L of fluoride) are consistently associated with lower IQ in children.”]. |
| The NTP report applies to New Zealand because the scientific evidence reviewed applies to the ranges of fluoridation New Zealand has. For example, the NTP recognised that the highest quality studies of the high-quality studies were in areas which were fluoridated at 0.7ppm i.e. Green (2019) & Till (2020). |
