As you might recall, the Court requested on the last day of the trial that we submit a new Petition to the Environmental Protection Agency (EPA) to allow them the opportunity to respond to our original 2016 Petition in regards to the new studies that were published between 2017-2020. The Court also requested that we include Petitioners who were pregnant or planning a pregnancy in light of the science linking early-life exposure to fluoridated water to adverse neurodevelopmental effects in these new studies.
Yesterday’s meeting with the Judge
At the very short meeting convened by the Judge, lawyers representing both sides were in attendance. Lead attorney Michael Connett told the Court that he filed, on November 4, a Supplement to our original Petition with the EPA. The Supplement asks that EPA reconsider their denial of our 2016 Petition. The reasons are set forth in the Supplement and its 9 attachments (all listed below). The Supplement has done everything the Court asked us to do with a new Petition. The Supplement also responds to the issue of Standing by identifying nine members of Food & Water Watch “who are currently pregnant, women who are actively seeking to become pregnant, and/or mothers of infants…”
We believe that this is an important and highly readable document and we urge our supporters to read it in full. However, if time is short we have presented excerpts below.
Background to the Supplement
“On November 22, 2016, the undersigned Petitioners submitted a Citizen Petition under Section 21 of the Toxic Substances Control Act (“TSCA”), requesting that the EPA prohibit the addition of fluoridation chemicals to drinking water in order to protect the public, including susceptible subpopulations, from fluoride’s neurotoxic risks. After the EPA denied this petition, the Petitioners brought suit in the Northern District of California to challenge EPA’s denial. Following a bench trial in June of 2020, the Court stated that EPA had used an incorrect standard in assessing the evidence that the Petitioners had presented. .. The Court also noted that much of the evidence that the Petitioners relied upon at trial—including recent studies funded by the National Institutes of Health (NIH)— was not yet available at the time EPA denied the Petition. (Appendix A at 4.) In light of these facts, the Court asked Petitioners to re-submit evidence to the EPA in order to give the Agency an opportunity to give the evidence a “second look” using the “proper standard” at the administrative level, which the Court ‘urged’ the EPA to do.”
“Pursuant to the Court’s request, the Petitioners are hereby submitting this Supplement to their Petition and requesting that EPA reconsider its denial of the Petition based on the information presented herein.”
EPA HAS THE AUTHORITY TO RECONSIDER ITS DENIAL OF A SECTION 21 PETITION
“EPA has the inherent authority to reconsider its denials of Section 21 petitions, as the EPA itself has repeatedly acknowledged. The EPA has explained that: “Although TSCA does not expressly provide for requests to reconsider EPA denials of Section 21 petitions, ‘the courts have uniformly concluded that administrative agencies possess inherent authority to reconsider their decisions, subject to certain limitations, regardless of whether they possess explicit statutory authority to do so.’” … As the EPA has explained, “the power to reconsider is inherent in the power to decide.” Id. at 24 (quoting Albertson v. FCC, 182 F.2d 397, 399 (D.C. Cir. 1950)) …”
GROUNDS FOR PETITIONERS’ REQUEST FOR RECONSIDERATION
1. EPA Used an Incorrect and Impermissibly Stringent Standard of Proof
“At the close of trial in June 2020, the Court observed that EPA has subjected Petitioners’ evidence to an incorrect standard of proof. As the Court noted, “EPA appears to have applied a standard of causation … It’s not the proper standard.” (6/17 Trial Tr. 1131:5-9.)
“TSCA commands that EPA protect against “unreasonable risk,” which exists when human exposure to a toxicant is unacceptably close to the estimated hazard level. (6/10 Trial Tr. 471:11-472:9.) At trial, EPA confirmed that ‘EPA does not require that human exposure levels exceed a known adverse effect level to make an unreasonable risk determination under TSCA.’ (Appendix H at 4.) Thus, EPA does not require proof that human exposures under a given condition of use cause the hazard. In fact, Dr. Tala Henry agreed at trial that EPA has “never once in any of its risk evaluations to date under Section 6 used a causation standard.” (6/16 Trial Tr. 987:6-8.) Despite this, Dr. Henry admitted that EPA held Petitioners to a burden of proof where Petitioners needed to prove that human exposure to fluoride in water at 0.7 mg/L causes neurotoxicity. (6/16 Trial Tr. 985-15-987:2.) Dr. Henry thus made the extraordinary admission that EPA ‘held the plaintiffs to a burden of proof that EPA has not held a single chemical under Section 6 before.’ (6/16 Trial Tr. 987:16-19.)…”
2. Each of the Limitations that EPA Identified with the Fluoride/IQ Studies in the Petition Have Now Been Addressed by High Quality Studies Funded by the NIH
“In its denial of the Petition, the EPA criticized the human studies that Petitioners cited on three primary grounds: (1) the studies were cross-sectional and thus ‘affected by antecedent consequent bias’;1 (2) the studies failed to adjust for potential confounding factors; and (3) the studies failed to adequately establish a dose-response relationship between fluoride and neurotoxicity. (Fed Reg, Vol. 82, No. 37, p. 11882-83). …
“Following EPA’s denial of the Petition in February 2017, a series of prospective cohort studies funded by the National Institutes of Health (NIH) were published which evaluate the impact of individualized measurements of prenatal and early-infant fluoride exposure on standardized measures of neurobehavioral performance between ages 4 and 12 (Bashash 2017, Bashash 2018, Green 2019, Till 2020).”
“These NIH-funded studies address each of EPA’s three criticisms of the studies in the Petition…”
3. The National Toxicology Program Has Concluded that Fluoride Is a Presumed Human Neurotoxicant that Lowers IQ in Children
“Petitioners’ contention that fluoride is a neurotoxicant has gained powerful new support from the National Toxicology Program’s (NTP) recently revised systematic review and meta-analysis…”
A. NTP Agrees that Fluoride Is a Likely Neurodevelopmental Hazard to Humans
“On September 16, 2020, the NTP released its Draft Monograph on the Systematic Review of Fluoride Exposure and Neurodevelopmental and Cognitive Health Effects. The Monograph is a revised version of a draft issued in October 2019, and incorporates the recommendations made by a committee of the National Academy of Sciences (NAS). After making the changes recommended by the NAS, the NTP reconfirmed its conclusion that ‘fluoride is presumed to be a cognitive neurodevelopmental hazard to humans.’ (p. 2) …”
B. The Relationship Between Fluoride and Neurotoxic Effects Is Unlikely to Be Explained by Confounding or Other Issues of Methodology and Bias
“The NTP reached its hazard conclusion for fluoride after carefully considering issues of study quality and bias, including potential confounding, publication bias, translation bias, and the validity of exposure and outcome assessments. Each of these methodological issues were raised at trial by EPA to question the confidence in the numerous studies reporting neurotoxicity from fluoride exposure. Importantly, the NTP’s report makes clear that none of the issues identified by EPA at trial warrant a downgrade in the confidence that fluoride is a human neurotoxicant. In other words, the issues identified by EPA at trial do not explain the overwhelmingly consistent association between fluoride and neurotoxic harm…”
C. The NTP Identified a Large Number of Low Risk-of-Bias Studies Linking Fluoride to Neurotoxicity
“… In total, the NTP identified 31 human studies on fluoride and neurodevelopment that it found to have a relatively low potential for bias (p. 25) and the vast majority of these studies found significant associations between fluoride and adverse effects. This highlights that the association between fluoride and neurotoxicity is not the artifact of poor study design or bias, as EPA argued at trial.”
D. The NTP Has Judged the New Zealand Studies that EPA Has Relied Upon to Be at High Risk of Bias
E. The Animal Data Supports the Conclusion that Fluoride Produces Neurodevelopmental Effects
F. The NTP’s Recently Retired Director Has Called for Measures to Protect Pregnant Women and Bottle-Fed Babies from the Neurotoxic Effects of Fluoride
“The relevance of the NTP’s findings to water fluoridation has recently been highlighted by none other than the recently retired director of the NTP, Dr. Linda Birnbaum. On October 7, 2020, shortly after the NTP released its revised Monograph, Dr. Birnbaum issued a public statement calling for measures to protect pregnant women and bottle-fed babies from the neurotoxic effects of fluoride. Dr. Birnbaum noted that the NTP’s conclusion is ‘consequential,’ given that “about 75 percent of Americans on community water systems have fluoride in their water.’…”
G. Limitations and Weaknesses of NTP’s Report
“The NTP Monograph provides an exceptionally comprehensive review of the scientific literature on fluoride neurotoxicity, and provides ample support for its conclusion that fluoride is a neurotoxicant that reduces IQ. There are, however, some limitations and weaknesses with the NTP’s analysis that Petitioners wish to bring to the EPA’s attention…”
H. Even with Its Limitations, the NTP Monograph Demonstrates that Water Fluoridation Poses an Unreasonable Risk of Neurodevelopmental Harm
“Even with its limitations, the NTP Monograph demonstrates that neurotoxicity is an unreasonable risk of water fluoridation…”
4. Pooled BMD Analysis of the NIH-Funded Birth Cohort Data Confirms that Pregnant Women in Fluoridated Areas Are Exceeding the Dose Associated with IQ Loss
“A team of scientists, including the authors of the NIH-funded studies, have recently completed a pooled benchmark dose (BMD) analysis of the maternal urinary fluoride data from the ELEMENT and MIREC datasets (Grandjean, et al. 2020, in review)… Given that BMD analysis is EPA’s preferred method for determining toxicity values and risk estimates, the new pooled analysis provides compelling grounds for EPA to reconsider its denial of the Petition. The analysis, which became publicly available on November 4, 2020, is attached as Appendix G…”
5. Millions of Americans Are at Risk of Harm as a Result of EPA’s Failure to Regulate Fluoridation, Including Petitioners
“… Each year, there are approximately 2.5 million pregnancies in fluoridated areas; in utero exposures are thus widespread. (Appendix B at p. 78 ¶ 406.) Many of those exposed in utero will also be exposed during the sensitive neonatal period, with upwards of 1.9 million infants living in fluoridated areas being fed formula at least part of the time, including 400,000 infants who are exclusively formula-fed for their first six months. (Id.) Petitioner Organizations have members who fall within these zones of danger…”
6. EPA Erred in Considering the Purported Dental Benefits of Fluoridation in its Denial of the Petition
“In its denial of the Petition, EPA cited the purported dental benefits of fluoridation as a basis for its denial. This was improper because the Amended TSCA statute forbids risk evaluations from considering ‘costs and other nonrisk factors.’ 15 U.S.C. § 2620(b)(4)(B(ii). …”
7. EPA Erred in Claiming that Petitioners Failed to Adequately Identify the Chemicals at Issue
“… During the litigation on this matter, the Court considered and rejected each of these arguments, and held that the Petitioners had adequately identified the chemicals at issue, and that there was no merit to EPA’s contention that it ‘would become obligated to address all conditions of use of the category.'”
List of Documents submitted:
|SUPPLEMENT: Petitioners’ request to EPA to reconsider their denial of their original TSCA Petition of November 22, 2016.
|Appendix A: Excerpt of Court’s August 10, 2020 Order.
|Appendix B: Petitioners’ Summary of the Trial Record. Food & Water Watch, et al. v. U.S. Environmental Protection Agency Case No. 17-cv-02162.
|Appendix C: The NIH-funded Studies (Bashash et al. 2017 and 2018; Till et al. 2018 and 2020; Green et al. 2019).
|Appendix D: National Toxicology Program’s Revised Monograph on Fluoride Neurotoxicity. http://fluoridealert.org/wp-
|Appendix E: Dr. Linda Birnbaum’s Statement on the NTP Report.
|Appendix F: Additional Details on the Limitations of the NTP Review.
|Appendix G: Pooled BMD Analysis of the ELEMENT and MIREC Datasets.
|Appendix H: Undisputed Material Facts from Trial and Court’s Ruling on Dental Benefits.
|Appendix I: The Court’s Order Dismissing EPA’s Order to Dismiss.