EPA Hits Key Milestone in Expedited Review of Fluoride under the Safe Drinking Water Act

EPA Hits Key Milestone in Expedited Review of Fluoride under the Safe Drinking Water Act

August 3, 2026

WASHINGTON - Today, U.S. Environmental Protection Agency (EPA) announced the next step in its review of public health risks linked to fluoride in drinking water: the release of the Protocol for Developing the Fluoride Human Health Toxicity Assessment. This marks a significant milestone in the agency's expedited assessment of fluoride under the Safe Drinking Water Act (SDWA), a priority set by EPA Administrator Lee Zeldin as part of the Trump Administration's commitment to Make America Healthy Again, while following gold standard science.

"Every American should be able to count on safe and healthy drinking water, plain and simple. In light of new science and real concerns from the public, the Trump EPA is working in lockstep with HHS to expedite our review of fluoride under the Safe Drinking Water Act," said EPA Administrator Lee Zeldin. "Today's important milestone means we are another step closer to completing this assessment years ahead of schedule. Our new action outlines specifically how EPA's assessment will be conducted and advances our commitment to transparency and gold standard science."

"Parents deserve the truth about fluoride in drinking water-not assumptions, not politics, but rigorous science," said U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr. "That is why HHS is working side by side with EPA to ensure this assessment focuses on the health risks that matter most for children, including neurodevelopmental effects and dental fluorosis. By conducting a rigorous dose-response analysis and making every step of the process transparent, we will give states, communities, and families the scientific foundation they need to make informed decisions about fluoride in drinking water."

Earlier this year, EPA released its Preliminary Assessment Plan and Literature Survey for public comment. The agency's new Protocol for Developing the Fluoride Human Health Toxicity Assessment reflects public input received on that plan. The Protocol is an essential part of developing the human health assessment; it is a road map that transparently describes how EPA will conduct the assessment while applying gold standard science.

EPA's assessment of fluoride under the SDWA will consider neurodevelopmental effects in children (e.g., negative effects on brain function, including lower IQ). EPA's assessment will also consider the negative health effects of dental fluorosis (e.g., discoloration and pitting of tooth enamel) in children. The agency will develop a human health toxicity assessment examining how much exposure to fluoride causes these negative health effects. This is called dose-response analysis, which EPA uses to determine the fluoride levels that a person can be exposed to without experiencing harmful health effects. The Protocol explains the scientific plan for conducting this analysis.

The agency will use this Protocol to develop the draft fluoride human health toxicity assessment, which once completed will be available for public comment. EPA will use systematic review practices that are consistent with gold standard science and SDWA requirements, draw on expertise from the U.S. Department of Health and Human Services (HHS), and will not prejudge any outcomes of the assessment. When final, the assessment will inform potential revisions to federal drinking water regulations. It will also help states and local leaders make informed decisions about fluoridating drinking water.

For more information on EPA's efforts on fluoride in drinking water and to view the Protocol for Developing the Fluoride Human Health Toxicity Assessment, please visit EPA's Fluoride in Drinking Water webpage.

Background
EPA's role under the SDWA is to limit the amount of contaminants in drinking water provided by public water systems to protect public health. EPA previously set the maximum contaminant level (MCL) for fluoride at 4.0 milligrams per liter, a standard designed to prevent known or anticipated adverse health effects that was set in 1986 and most recently reviewed in 2024. Under normal SDWA timelines, the next comprehensive analysis of new scientific information, which includes evaluation of the potential health risks of fluoride in drinking water would not be due until 2030, but EPA has accelerated this work to deliver updated health information to the public sooner while maintaining rigorous review and quality controls.

Decisions on whether to add fluoride to drinking water are guided by public health recommendations from HHS and the Centers for Disease Control and Prevention (CDC) and are ultimately made at the state or local level. U.S. Public Health Service has issued Recommendations for Fluoride Concentration in Drinking Water for the Prevention of Dental CariesExit EPA's website, otherwise known as tooth decay. CDC's Community Water Fluoridation Program recommends amounts of fluoride in drinking water to best prevent cavities. Their recommended optimal level of fluoride is 0.7 milligrams per liter. These recommendations are just that - recommendations that are advisory and do not apply to EPA's authority under the SDWA.

The federal regulatory standards set by EPA apply regardless of whether fluoride is naturally occurring in a system's source water or is intentionally added by the water system. EPA's responsibility is to ensure that overall fluoride levels remain within health-protective limits, but the agency does not make policy recommendations to state or local systems to add fluoride to drinking water.