The Environmental Protection Agency on Aug. 3 released the Protocol for Developing the Fluoride Human Health Toxicity Assessment, a key milestone in its expedited review of public health risks from fluoride in drinking water.
The protocol sets out the scientific roadmap for how the formal toxicological review will be conducted. It is not itself a regulatory action but establishes the methodology that will ultimately inform EPA’s Maximum Contaminant Level for fluoride under the Safe Drinking Water Act.
Fluoride has been added to municipal water supplies for more than 70 years as a public dental health measure. Recent court decisions and scientific reviews, however, have challenged the sufficiency of prior risk assessments and prompted the federal government to revisit the issue.
The assessment comes amid heightened scrutiny of water fluoridation policy. HHS Secretary Robert F. Kennedy Jr. has been among the most prominent critics of current fluoridation practices, and a 2024 federal court ruling ordered the EPA to take further regulatory action on fluoride.
Hundreds of millions of Americans receive fluoridated tap water from municipal systems. Any change to the EPA’s maximum contaminant level would affect water treatment operations and public health policies across thousands of community water systems.
The American Dental Association has long supported community water fluoridation as safe and effective in preventing tooth decay. Critics cite studies suggesting potential neurodevelopmental effects at certain exposure levels.
The protocol release opens a formal process that will include peer review and public comment before any regulatory action is proposed.