The EPA’s fluoride health risk assessment for drinking water has entered a new phase as the organization released its protocol for developing the Fluoride Human Health Toxicity Assessment. The protocol establishes the scientific framework that will guide the agency’s evaluation of potential health risks associated with fluoride exposure in drinking water under the Safe Drinking Water Act (SDWA). The review, which has been prioritized by EPA Administrator Lee Zeldin, will examine evidence on fluoride’s effects on human health, including neurodevelopmental impacts in children and dental fluorosis, while following a transparent, science-based assessment process.

Once completed, the findings could help shape future federal drinking water standards and support state and local decisions on water fluoridation.

EPA Releases Scientific Protocol for Fluoride Review

The newly published protocol serves as a roadmap explaining how the EPA will conduct its toxicity assessment using systematic scientific methods.

• Earlier this year, the agency released a Preliminary Assessment Plan and Literature Survey for public comment.
• Feedback received during that consultation has now been incorporated into the finalized protocol, ensuring that the assessment process remains transparent and consistent with established scientific practices.

EPA Administrator Lee Zeldin said the milestone brings the agency closer to completing the review ahead of its original schedule while maintaining rigorous scientific standards.

Key Elements of the Assessment

The assessment will not predetermine any conclusions but will evaluate the available scientific evidence before reaching findings.

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Focus on Children’s Health

A major component of the EPA’s fluoride health risk assessment for drinking water is evaluating potential health impacts on children.

The EPA will assess research on neurodevelopmental effects, including possible impacts on brain function and cognitive development, as well as dental fluorosis, a condition that can cause discoloration or pitting of tooth enamel when fluoride exposure is excessive during tooth development.

According to the agency, the assessment will use dose-response analysis to determine fluoride exposure levels at which harmful health effects may occur. This process is widely used in environmental health assessments to establish safe exposure thresholds.

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Collaboration Between EPA and HHS

The review is being conducted in collaboration with the U.S. Department of Health and Human Services (HHS).

HHS Secretary Robert F. Kennedy Jr. said the assessment is intended to provide parents and communities with transparent scientific evidence regarding fluoride exposure. He emphasized that the review will focus on health outcomes that are particularly relevant to children while ensuring every stage of the process remains open and evidence-based.

Both agencies stated that the assessment will rely on systematic review methods consistent with current scientific standards and the requirements of the Safe Drinking Water Act.

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What Happens Next?

Using the newly released protocol, the EPA will prepare a draft fluoride human health toxicity assessment, which will be made available for public review and comment before being finalized.

Once complete, the assessment could serve as the scientific foundation for possible revisions to federal drinking water regulations. It will also provide states and local governments with updated evidence to support decisions regarding community water fluoridation programs.

By combining public input, systematic scientific review and interagency expertise, the EPA aims to ensure that future decisions on fluoride in drinking water are based on the latest available health evidence while maintaining transparency throughout the regulatory process.

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