https://ntp.niehs.nih.gov/go/785076

Fluoride: Assessment for Developmental Neurotoxicity

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Topic Overview

CASRN: 16984-48-8
Status: Topic under evaluation

Background Information

The National Toxicology Program (NTP) conducted a systematic review of the scientific research on fluoride exposure and neurodevelopmental and cognitive health effects in humans. The report underwent two peer reviews by the National Academies of Science, Engineering, and Medicine (NASEM). Both times, the NASEM committee stated that NTP had not adequately supported its conclusions that fluoride should be classified as a cognitive neurodevelopmental hazard for humans.

Based on the NASEM review, the NTP removed the hazard classification of fluoride and made additional changes, resulting in two draft documents, 1) an NTP Monograph on the State of the Science that considered research published through May 2020, and 2) a manuscript on the meta-analysis of the data that considered research published through November 2021.

In May 2022, NTP Director Rick Woychik, Ph.D., decided to delay publication of the monograph and tasked the NTP Board of Scientific Counselors (BSC) to conduct a scientific review of NTP’s responses to 325 comments and criticisms on the monograph received from external peer reviewers and federal agency experts. The BSC had already been tasked with reviewing NTP’s responses to 141 comments received on the meta-analysis manuscript.

A Working Group of the BSC was convened to assist with the scientific review. In two public meetings, May 4 and 16, 2023, the Working Group presented its report to the BSC.

The Working Group report recommended 93 revisions to the monograph and 81 revisions to the meta-analysis manuscript. The BSC accepted the Working Group’s recommendation to revise both the monograph and meta-analysis manuscript prior to publication. The recommended revisions were to address scientific issues, insufficiency of information, lack of precision in the text, and additional research needs.

The BSC transmitted the Final Working Group Report to Dr. Woychik for his consideration.

The authors of the monograph and meta-analysis manuscript are currently making the recommended revisions. Dr. Woychik will make a final decision regarding publication of the NTP Monograph on the State of the Science and the meta-analysis manuscript.

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Documents

Documents for Fluoride: Potential Developmental Neurotoxicity
Date Document
Oct 07, 2015 Federal Register notice requesting information on nominated substances
Nov 19, 2015 Proposed NTP Evaluation on Fluoride Concept
Dec 02, 2015 Presentation: NTP Evaluation of Fluoride Exposure and Potential for Developmental Neurobehavioral Effects
Jul 01, 2016 Completed Systematic Review
Preferred Citation: NTP (National Toxicology Program). 2016. Systematic Literature Review on the Effects of Fluoride on Learning and Memory in Animal Studies. NTP Research Report 1. Research Triangle Park, NC: National Toxicology Program.
Jun 01, 2017 NTP Protocol for Systematic Review of Human, Animal, and Mechanistic Evidence
May 29, 2019 NTP Protocol for Systematic Review of Human, Animal, and Mechanistic Evidence - First Revision
Sept 16, 2020 NTP Protocol for Systematic Review of Human, Animal, and Mechanistic Evidence - Second Revision
Sept 16, 2020 Literature Search Results
Mar 15, 2023 Table of Contents
Documents Provided to the NTP Board of Scientific Counselors (BSC) and BSC Working Group
May 18, 2023 Transmittal Letter
Final Version of the NTP Board of Scientific Counselors Working Group Report
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Meetings & Events

Listing of related events
Date Event Event Type Materials
May 04, 2023

Board of Scientific Counselors Meeting

Board of Scientific Counselors
  • Agenda
  • Meeting Materials

    Federal Register Notices
    May 4, 2023

    Board of Scientific Counselors Meeting Meeting Materials
    May 4-5, 2023

    Charge
    NTP Board of Scientific Counselors Working Group Report
    Table of Contents and Documents Provided to the NTP Board of Scientific Counselors (BSC) and BSC Working Group
    Fluoride: Assessment for Developmental Neurotoxicity web page on NTP website

     

    Public Comments

    Name, Affiliation, Sponsorship Technical and Scientific Public Comments
    J. William Hirzy, PhD, on behalf of the National Federation of Federal Employees, Local 2050 Public comment received April 27, 2023
    Rick North, Private Citizen Public comment received April 27, 2023
    Mark Moss, DDS, PhD, East Carolina University Public comment received April 27, 2023
    William Maas, DDS, MPH, MS, University of Maryland School of Dentistry Public comment received April 27, 2023
    George R. Shepley, DDS, and Raymond A. Cohlmia, DDS, on behalf of the American Dental Association Public comment received April 28, 2023
    Brian R. Berridge, DVM, PhD, B2 Pathology Solutions LLC Public comment received April 28, 2023
    Jack Kall, DMD, on behalf of the International Academy of Oral Medicine and Toxicology Public comment received April 28, 2023
    Bill Osmunson, DDS, MPH, on behalf of Washington Action for Safe Water, King County Citizens Against Fluoridation Public comment received April 28, 2023
    Public comment received May 10, 2023
    Christopher H. Fox, DMD, DMSc, and Alexandre Vieira, DDS, MS, PhD, on behalf of the American Association for Dental, Oral, and Craniofacial Research Public comment received April 28, 2023
    Paul Connett, PhD, on behalf of the Fluoride Action Network Public comment received April 28, 2023
    Chris Neurath, on behalf of the American Environmental Health Studies Project Public comment received April 29, 2023
    John F. Mueller Jr., Private Citizen Public comment received May 3, 2023
    Howard Pollick, MPH, on behalf of the American Dental Association Public comment received May 4, 2023

  • Members
  • Minutes
  • Presentations
  • Videos

    Board of Scientific Counselors Meeting Videos
    May 4, 2023

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    Videos and Closed Captioning

    May 4, 2023

    PM Part 1
     

     

    PM Part 2
     
Oct 19, 2020

Peer Review of the Revised NTP Monograph on Fluoride Exposure and Neurodevelopmental and Cognitive Health Effects by the National Academies of Science, Engineering, and Medicine

Expert Panels - Other Panels
    Nov 06, 2019

    Peer Review of the Draft NTP Monograph on Systematic Review of Fluoride Exposure and Neurodevelopmental and Cognitive Health Effects by the National Academies of Science, Engineering, and Medicine

    Expert Panels - Other Panels
      Dec 01, 2015

      NTP Board of Scientific Counselors Meeting

      Board of Scientific Counselors
      • Agenda
      • Meeting Materials

        NTP Board of Scientific Counselors Meeting Meeting Materials
        December 1-2, 2015

        Supplemental materials for some events, meetings, and workshops prior to 2020 have been archived. These archived materials frequently include presentations, background materials, and public comments. Email us or use our contact form to request a list or copy of archived materials.

          

      • Minutes
      May 16, 2023

      Board of Scientific Counselors Meeting

      Board of Scientific Counselors

      Supplemental materials for some events, meetings, and workshops prior to 2020 have been archived. These archived materials frequently include presentations, background materials, and public comments. Email us or use our contact form to request a list or copy of archived materials.
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