Case Number:  Civ. No. 17-CV-02162-EMC  
Food & Water Watch, Inc. et al v. Environmental Protection Agency et al 

We won!  We received our court decision on Tuesday, Sept 24, 2024.  Here is a link to the full court ruling:  FINDINGS OF FACT AND CONCLUSIONS OF LAW  

Here are some notable excerpts from the ruling provided by the Fluoride Action Network:

pg 3: There is little dispute in this suit as to whether fluoride poses a hazard to human health. Indeed, EPA’s own expert agrees that fluoride is hazardous at some level of exposure. And ample evidence establishes that a mother’s exposure to fluoride during pregnancy is associated with IQ decrements in her offspring. 

pg 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.

pg 5: Even if the toxicologically determined hazard level of 0.28 mg/L were deemed insufficiently substantiated, evidence in the record still establishes with little doubt that fluoridated drinking water presents a risk of injury to health.

6: The EPA’s default margin of error requires a factor of 10 between the hazard level and exposure level due to variability in human sensitivities…Here, an even greater margin (100x) is owed because the methodology (which yields the 4 mg/L hazard level) uses the lowest observed adverse effect level (“LOAEL”); this methodology adds an additional level of uncertainty (and hence the application of a 100x rather than 10x margin). But even if only the default 10x margin is required, the safe level of fluoride exposure would be 0.4 mg/L (4 mg/L (hazard level) divided by 10). The “optimal” water fluoridation level in the United States of 0.7 mg/L is nearly double that safe level of 0.4 mg/L for pregnant women and their offspring.

pg 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.

pg 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.

pg 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

pg 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.

Closing Arguments occurred on Tuesday, February 20, 2024 at 11:30AM (CST)  with Senior District Judge Edward M. Chen 3:17-cv-02162-EMC - Food & Water Watch, Inc. et al v. Environmental Protection Agency et al.  

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