The TSCA Law Suit Documents: (2016-present)
The following are the submissions entered into the law suit against the U.S. Environmental Protection Agency (EPA) under Section 21 of the Toxic Control Substances Act (TSCA) by the Fluoride Action Network, Food & Water Watch, and Moms Against Fluoridation.
See also
• News articles relating to law suit
• The Timeline of the TSCA law.
| DATE | ABOUT | TITLE | |
| June 10, 2021 | Plaintiffs filed Notice to the court. They state, “On August 10, 2020, the Court held this case in abeyance pending the publication of additional studies, including the National Toxicology Program’s systematic review of fluoride neurotoxicity and a pooled benchmark dose (BMD) analysis of the NIH-funded ELEMENT and MIREC cohorts. See ECF No. 262 at 4:19-26. On June 8, 2021, the pooled BMD analysis of the ELEMENT and MIREC data was published in the journal Risk Analysis, which is the official publication of the Society for Risk Analysis. The results of the peer-reviewed, pooled analysis are consistent with, and confirm, Dr. Philippe Grandjean’s earlier benchmark dose analysis that was discussed at trial and “can be used to guide decisions on preventing excess fluoride exposure in pregnant women.” According to the study, which was authored by ten internationally esteemed scientists, including Dr. Grandjean:”These findings provide additional evidence that fluoride is a developmental neurotoxicant (i.e., causing adverse effects on brain development in early life). Given the ubiquity of fluoride exposure, the population impact of adverse effects from fluoride may be even greater than for other toxic elements like lead, mercury, and arsenic.” LINK: http://fluoridealert.org/wp-content/uploads/tsca-trial.notice-of-bmd-anaysis.6-10-21.pdf |
Notce of the publication of the pooled Benchmark Dose analysis of the Element and MIREC Cohorts. | |
| May 11, 2021 | The Court GRANTS Plaintiffs’ motion for leave to supplement their complaint. Should the EPA seek to challenge Plaintiffs’ standing, it shall file a motion to dismiss within thirty (30) days from the date of this order. The abeyance of this case otherwise remains in place until further ordered. This order disposes of Docket No. 279 | Court Order granting Plaintiffs’ motion for leave to supplement complaint | |
| April 22, 2021 | Plaintiffs’ reply in support of their motion for leave to amend their complaint with supplemental pleadings. | Plainitiff’s Reply in Support of their Motion | |
| February 22, 2021 | Defendant’s statement on the the peer review by the National Academies of Science, Engineering and Medicine (NASEM) of the revised National Toxicology Program (NTP) monograph on the systematic review of fluoride’s neurotoxicity and the joint statement by the NIEHS and NTP. Both dated on Feb 9, 2021. | Defendant’s submission of two Exhibits | |
| February 22, 2021 | EXHIBIT A. Peer-review of the NASEM of the revised NTP monograph on fluoride’s neurotoxicity dated February 9, 2021. | Defendant’s Exhibit A, NASEM peer-review. | |
| February 22, 2021. | EXHIBIT B. Joint statement of the NIEHS and NTP on the downgrade of the monograph of the systematic review of fluoride’s neurotoxicity dated February 9, 2021. | Defendant’s Exhibit B, NIEHS-NTP statement | |
| February 19, 2021 | Plaintiffs reinforce their standing by citing legal precedents. | Plaintiffs Motion to Amend their Complaint | |
| January 19, 2021 | EPA’s 7-page letter denying the Petitioners’ Supplemental Petition http://fluoridealert.org/wp-content/uploads/tsca.epa-letter.denial-of-petiiton.jan-19-2021.pdf |
EPA’s letter denying the Petitioners’ Supplemental Petition | |
| January 13, 2021 | EPA’s Order Denying in Part Petitioners’ Supplemental Petition http://fluoridealert.org/wp-content/uploads/tsca.epa-letter.denial-of-petiiton.jan-19-2021.pdf |
EPA’s Order Denying in Part Defendant’s Motion for Relief | |
| January 13, 2021 | EPA’s response to Petitioners Supplemental Petition of November 4, which the judge requested the Petitioners to submit. http://fluoridealert.org/wp-content/uploads/tsca.court-order.jan-13-2021.pdf |
Order Denying in Part Defendant’s Motion for Relief | |
| November 4, 2020 | SUPPLEMENT: Petitioners’ request to EPA to reconsider their denial of their original TSCA Petition of November 24, 2016 LINK: http://fluoridealert.org/wp-content/uploads/tsca.supplement.11-4-20.pdf |
SUPPLEMENT TO ORIGINAL PETITION | |
| November 4, 2020 | Appendix A to Supplement: Excerpt of Court’s August 10, 2020 Order. – LINK: http://fluoridealert.org/wp-content/uploads/tsca.supplement.appendix-a.11-4-20.pdf |
APPENDIX A to Supplement of Nov 4, 2020 |
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| November 4, 2020 | Appendix B to Supplement: Petitioners’ Summary of the Trial Record. Food & Water Watch, et al. v. U.S. Environmental Protection Agency Case No. 17-cv-02162. – LINK: http://fluoridealert.org/wp-content/uploads/tsca.supplement.appendix-b.11-4-20.pdf |
APPENDIX B to Supplement of Nov 4, 2020 |
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| November 4, 2020 | Appendix C to Supplement: The NIH-funded Studies (Bashash et al. 2017 and 2018; Till et al. 2018 and 2020; Green et al. 2019). – LINK: http://fluoridealert.org/wp-content/uploads/tsca.supplement.appendix-c.11-4-20.pdf |
APPENDIX C to Supplement of Nov 4, 2020 |
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| November 4, 2020 | Appendix D to Supplement: National Toxicology Program’s Revised Monograph on Fluoride Neurotoxicity. – LINK: http://fluoridealert.org/wp-content/uploads/tsca.supplement.appendix-d.11-4-20.pdf |
APPENDIX D to Supplement of Nov 4, 2020 |
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| November 4, 2020 | Appendix E to Supplement: Dr. Linda Birnbaum’s Statement on the NTP Report. – LINK: http://fluoridealert.org/wp-content/uploads/tsca.supplement.appendix-e.11-4-20.pdf |
APPENDIX E to Supplement of Nov 4, 2020 |
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| November 4, 2020 | Appendix F to Supplement: Additional Details on the Limitations of the NTP Review. – LINK: http://fluoridealert.org/wp-content/uploads/tsca.supplement.appendix-f.11-4-20.pdf |
APPENDIX F to Supplement of Nov 4, 2020 |
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| November 4, 2020 | Appendix G to Supplement: Pooled BMD Analysis of the ELEMENT and MIREC Datasets. – LINK: http://fluoridealert.org/wp-content/uploads/tsca.supplement.appendix-g.11-4-20.pdf |
APPENDIX G to Supplement of Nov 4, 2020 |
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| November 4, 2020 | Appendix H to Supplement: Undisputed Material Facts from Trial and Court’s Ruling on Dental Benefits. – LINK: http://fluoridealert.org/wp-content/uploads/tsca.supplement.appendix-h.11-4-20.pdf |
APPENDIX H to Supplement of Nov 4, 2020 |
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| November 4, 2020 | Appendix I to Supplement: The Court’s Order Dismissing EPA’s Order to Dismiss. – LINK: http://fluoridealert.org/wp-content/uploads/tsca.supplement.appendix-i.11-4-20.pdf |
APPENDIX I to Supplement of Nov 4, 2020 |
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| December 30, 2019 | TSCA Petition: Ruling by Edward M. Chen, United States District Judge, Northern District of California |
Order denying Plaintiffs’ and Defendant’s Motion for Summary Judgment | |
| December 20, 2019 | TSCA Petition: Plaintiff’s theory of the case Key evidence Response to anticipated defenses Standing |
Plaintiffs’ Trial Brief | |
| December 19, 2019 | TSCA Petition: Hazard Assessment Human Studies NTP’s Assessment of the Epidemiological Literature Exposure Assessment Risk Characterization Absence of Systematic Review Standing and more… |
Plaintiffs’ Proposed Findings of Fact | |
| December 19, 2019 | TSCA Petition: The Action Undisputed Facts Disputed Factual Issues Disputed Legal Issues Trial Alternatives and Options EPA’s position |
Defendant’s Joint Pretrial Conference Statement | |
| October 24, 2019 | TSCA Petiion: INTRODUCTION: Plaintiffs agree with EPA that “this case is about dose.” Opp. Br. at 1:4. It is a case about a chemical (fluoride) that is added to U.S. public water supplies at a concentration that produces doses repeatedly associated (in high-quality prospective studies) with neurotoxic effects that rival the impact of lead. It is a case about a chemical shown to cause neurotoxic effects in animals at doses much closer to the doses that humans receive than the margins that EPA has found to be unreasonably dangerous for other chemicals. Most importantly, it is a case about a chemical that that poses an unreasonable risk of neurotoxicity when added to water if judged according to EPA’s own risk assessment procedures.In its Opposition, EPA concedes that conclusive proof of harm is not a pre-requisite to a finding of risk, which vitiates EPA’s experts’ opinions on causation. Further, EPA’s reliance on the Framework for Metals Risk Assessment to support consideration of health benefits is fundamentally flawed because the Framework is clear that only “essentiality” can be considered in risk assessment, and EPA has admitted that fluoride is not essential. Finally, EPA has failed to proffer any evidence on the relative risk of the chemicals it is handling under TSCA, thus confirming that the Agency will not be able to carry its burden for relief under Section 21(b)(4)(B)(ii). |
Plaintiffs’ Opposition to Defendant’s Motion for Summary Judgment | |
| October 24, 2019 | TSCA Petition: EPA presents arguments as to why the court should not proceed with this case. |
Defendant’s Reply in Support of their Motion for Summary Judgment | |
| October 18, 2019 | TSCA Petition: Plaintiff’s response to Defendant’s Motion of October 9. |
Plaintiffs’ Opposition to Defendant’s Motion for Summary Judgment | |
| October 18, 2019 | TSCA Petition: Defendant’s (EPA) response to Plaintiff’s Motion of October 9. |
Defendant’s Opposition to Plaintiffs’ Motion for Summary Judgment and Partial Summary Judgment | |
| October 9, 2019 | TSCA Petition: CONCLUSION: Congress enacted Section 21 to “ensure that bureaucratic lethargy does not prevent the appropriate administration of [TSCA’s] vital authority.” Environmental Defense Fund v. Reilly, 909 F.2d 1497, 1499 (D.C. Cir. 1990). This is precisely why Plaintiffs filed their Citizen Petition, because EPA has failed to protect the public from the dangers posed by fluoride in drinking water. EPA’s current “safe” drinking water standard for fluoride is so high that its own scientists sought to file an amicus brief to support an environmental organization’s challenge to it. Ex. 6 at 79:20-81:12, 81:25-82:8. EPA’s current lead scientist on fluoride admits that EPA’s fluoride standard is “out of date,” and the National Research Council told the EPA 13 years ago that this standard is unsafe and needs to be lowed. Ex. 4 at 88:7-10, 90:15-21. And yet EPA has done nothing. Id. at 88:2-6. It was thus left to citizen groups to compel the Agency to take action by exercising the authority that Congress invested in the citizenry for this very purpose. Now, after two years of litigation, Plaintiffs respectfully request—for the reasons stated above—that the Court grant their Motion for Summary Judgment and/or Partial Motion for Summary Judgment. |
Plaintiffs’ Notice of Motion & Motion for Summary Judgment and Partial Summary Judgment | |
| October 9, 2019 | TSCA Petition: Most of the arguments in this Motion have been responded to in the Plaintiffs’ Motion above. |
Defendants’ Notice of Motion for Summary Judgment | |
| September 25, 2019 | TSCA Petition: Judge’s decision to deny Defendants’ (EPA) Motion to extend discovery. |
Order denying defendants’ motion for extension of time | |
| September 23, 2019 | TSCA Petition: Plaintiffs oppose EPA’s motion to derail the entire schedule of this case (which EPA stipulated to just one week before its motion) based on a draft review that EPA has known about for years, and an unjustified, last-minute disclosure of an expert whom EPA knew about since at least June 27, 2019. |
Plaintiffs’ Opposition to Defendants’ Motion to enlarge time for limited expert discovery | |
| September 19, 2019 | TSCA Petition: … EPA seeks an extension of time for limited expert discovery to minimize the inefficiency and/or confusion that could otherwise result from proceeding with litigation prior to public disclosure of the NTP Monograph. The public release of the NTP Monograph will likely necessitate supplementation of either parties’ expert disclosures pursuant to Federal Rule of Civil Procedure 26(e). Delay and inefficiency would occur if the parties were forced to begin dispositive motions briefing prior to the record being complete. The more efficient approach is to amend the current Scheduling Order to ensure a complete record prior to the filing of dispositive motions. EPA seeks an additional 65 days, until November 22, 2019, to conduct additional expert discovery that is limited to (1) supplementing current expert reports/disclosures regarding the forthcoming NTP Monograph; and (2) to allow the parties an opportunity to depose the expert witness identified in EPA’s supplemental disclosure and to re-depose witnesses whose expert reports are amended to reflect the NTP Monograph. Further, EPA seeks a temporary stay of the remaining deadlines in this case to allow the parties time to negotiate a revised schedule, which may include seeking a new trial date. EPA proposes that the parties be required to file a joint case management statement in 45 days… |
Defendants’ Motion to enlarge time for limited expert discovery | |
| October 4, 2018 | TSCA Petition: Plaintiffs’ request for an order compelling the Environmental Protection Agency to produce documents responsive to requests 10 – 29 and 33 – 34 is GRANTED… The EPA’s documents and correspondence relating to the specified studies are relevant to the ultimate issue the Court must decide — whether the ingestion of fluoride in drinking water causes neurotoxic harm. To the extent that the EPA asserts the deliberative process privilege over any responsive documents, it shall provide a privilege log within 14 days of this Order detailing: (1) the date of the document, (2) the author, (3) the recipient, (4) the subject matter, and (4) the basis for asserting the privilege.
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Order Re First Joint Discovery Dispute Letter | |
| February 7, 2018 | TSCA Petition: The court ruled: “The EPA moves for a protective order limiting the scope of review in this litigation to the administrative record1, a request that would effectively foreclose Plaintiffs from introducing any evidence in this litigation that was not attached to their administrative petition. The text of the TSCA, its structure, its purpose, and the legislative history make clear that Congress did not intend to impose such a limitation in judicial review of Section 21 citizen petitions. The Court therefore DENIES the EPA’s motion.” |
Order Denying Defendant’s (EPA) Motion to Limit Review to the Administrative Record | |
| January 18, 2018 | TSCA Petition: EPA response to each (107) paragraph in FAN et al’s “Complaint” of April 18, 2017, concluding: “Except as expressly admitted or otherwise stated herein, EPA denies each and every allegation in Plaintiff’s Complaint.” |
The Defendant, EPA, “Answer” to FAN et al’s “Complaint of Fluoride’s harm submitted April 18, 2017. | |
| January 15, 2018 | TSCA Petition: EPA’s “further support of their motion for a protective order limiting review to the administrative record.” |
Federal Defendant’s Reply in Further Support of Motion to Limit Review to Administrative Record. | |
| January 5, 2018 | TSCA Petition: FAN et al’s opposition to EPA’s motion to the court for a sweeping order that would exempt this “civil action” from Federal Rule of Civil Procedure 26(b) and deny Plaintiffs their right to discovery. |
Plaintiffs’ Opposition to the Federal Defendants’ Motion to Limit Review to the Administrative Record and to Strike Plaintiffs’ Jury Demand | |
| January 5, 2018 | TSCA Petition: NRDC opposes EPA’s motion to limit petitioner’s right to discovery. They state, “To the contrary, the language, structure, and history of section 21 all support the district court’s consideration of new evidence.” |
[Proposed] Amicus Curiae Brief of Natural Resources Defense Council, Inc., and Safer Chemicals, Healthy Families in Response to EPA’s Motion to Limit Review (Supporting Neither Party on the Merits) | |
| December 21, 2017 | TSCA Petition: Court rules in our favor and denies EPA’s Motion to Dismiss. |
U.S. District Court, Northern District of California. ORDER DENYING DEFENDANT’S MOTION TO DISMISS Docket No. 28 | |
| December 14, 2017 | TSCA PETITION: EPA requests court for “a protective order limiting review to the administrative record and an order striking Plaintiffs’ Jury Demand.” |
Federal Defendants’ Notice of Motion and Motion to Limit Review to the Administrative Record and to Strike Plaintiffs’ Jury Demand | |
| October 25, 2017 | TSCA Petition: NRDC Amicus Curiae Brief in support of FAN et al’s challenge to EPA on Section 21 of TSCA. |
[Proposed] Amicus Curiae Brief of Natural Resources Defense Council and Safer Chemicals, Healthy Families in Support of Neither Party | |
| October 25, 2017 | TSCA Petition: FAN et al. response to EPA’s rejection of Petition. |
Plaintiffs’ Opposition to the Environmental Protection Agency’s Motion to Dismiss | |
| September 25, 2017 | TSCA Petition: Motion to Dismiss FAN et al. Petition by the Department of Justice, on behalf of the EPA. |
Federal Defendants’ Noticice of Motion and Motion to Dismiss. | |
| April 18, 2017 | TSCA Petition: Response to U.S. EPA’s rejection of Petition |
Complaint to United States District Court for the Northerv District of California at San Francisco |
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| February 27, 2017 | TSCA Petition: EPA’s Rejection of FAN et al. Petition. Federal Register. EPA–HQ–OPPT–2016–0763; FRL–9959–74] |
TSCA Section 21 Petition; Reasons for
Agency Response.
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| November 22, 2016 | TSCA Petition: Petition to the U.S. EPA to ban fluoridation due to fluoride’s neurotoxicity, submitted by Fluoride Action Network, Food & Water Watch, Organic Consumers Association, American Academy of Environmental Medicine, International Academy of Oral Medicine and Toxicology, Moms Against Fluoridation, and undersigned individuals. |
Petition under Section 21 of the Toxic Substances Control Act (“TSCA”), 15 U.S.C. § 2620, to EPA Administrator Gina McCarthy. | |
* The Original Petitioners:
Fluoride Action Network
Food & Water Watch
American Academy of Environmental Medicine
International Academy of Oral Medicine and Toxicology
Moms Against Fluoridation
Organic Consumers Association
And Individuals:
Audrey Adams, a resident of Renton, WA (individually and on behalf of her son),
Jacqueline Denton, a resident of Asheville, NC (individually and on behalf of her children),
Valerie Green , a resident of Silver Spring, MD (individually and on behalf of her children),
Kristin Lavelle, a resident of Berkeley, CA (individually and on behalf of her son),
Brenda Staudenmaier from Green Bay, WI (individually and on behalf of her children)
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