EPA releases fluoride toxicity assessment protocol: 7 notes – Becker’s Dental Review

The Environmental Protection Agency has released the Protocol for Developing the Fluoride Human Health Toxicity Assessment, marking the latest step in its expedited review of fluoride in drinking water under the Safe Drinking Water Act.

Seven notes:

1. The protocol, released Aug. 3, is a scientific roadmap describing how EPA will conduct its human health toxicity assessment of fluoride. It reflects public input from EPA’s earlier Preliminary Assessment Plan and Literature Survey, which the agency began collecting public input on in January. 
2. EPA will use the protocol to develop a draft toxicity assessment, which will then be made available for public comment before being finalized.
3. The assessment will focus on two areas: neurodevelopmental effects in children and dental fluorosis. It will use dose-response analysis to determine fluoride exposure levels that can occur without harmful health effects.
4. EPA’s current maximum contaminant level for fluoride is 4.0 milligrams per liter, set in 1986 and most recently reviewed in 2024. The CDC recommends an optimal level of 0.7 milligrams per liter for preventing tooth decay. 
5. Under normal Safe Drinking Water Act timelines, a comprehensive new assessment would not have been due until 2030, but EPA accelerated the process as part of the Trump Administration’s Make America Healthy Again initiative, according to a news release from the agency.
6. When finalized, the assessment will inform potential revisions to federal drinking water regulations and help state and local leaders make decisions about water fluoridation. Decisions on whether to add fluoride to drinking water are currently made at the state or local level.
7. The review is being conducted in coordination with HHS. EPA said it will apply systematic review practices consistent with Safe Drinking Water Act requirements and will not prejudge any outcomes of the assessment.

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