[Federal Register Volume 91, Number 18 (Wednesday, January 28, 2026)]
[Notices]
[Pages 3722-3724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-01657]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OW-2025-3823; FRL 13191-01-OW]
Review of Science on Fluoride in Drinking Water: Preliminary
Assessment Plan and Literature Survey
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability.
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SUMMARY: As the first step in developing the Fluoride Human Health
Toxicity Assessment (toxicity assessment), the U.S. Environmental
Protection Agency (EPA) is releasing the Fluoride Preliminary
Assessment Plan and Literature Survey (Assessment Plan) for public
comment to provide
[[Page 3723]]
transparency and gather early feedback. The objectives of the
Assessment Plan are to describe the approach the EPA intends to follow
to develop the fluoride toxicity assessment and present the results of
the preliminary literature survey. The Assessment Plan is not a
toxicity assessment; it does not contain conclusions regarding harmful
human health effects of fluoride or determine the level of fluoride
exposure at or above which is associated with harmful health effects.
Such conclusions about fluoride human health effects will be released
as part of the forthcoming draft human health toxicity assessment. The
EPA's toxicity assessment will be used to inform future decisions about
potential revisions to the existing fluoride drinking water standard
under the Safe Drinking Water Act (SDWA). This notice outlines details
on how to provide comments and describes the purpose of the Fluoride
Preliminary Assessment Plan and Literature Survey.
DATES: Comments must be received on or before states February 27, 2026.
ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OW-2025-3823, by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov/
(our preferred method). Follow the online instructions for submitting
comments.
Email: [email protected]. Include Docket ID No. EPA-HQ-OW-
2025-3823 in the subject line of the message.
Mail: U.S. Environmental Protection Agency, EPA Docket
Center, Office of Ground Water and Drinking Water Docket, Mail Code
28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460.
Hand Delivery or Courier: EPA Docket Center, WJC West
Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004.
The Docket Center's hours of operations are 8:30 a.m. to 4:30 p.m.,
Monday through Friday (except Federal Holidays).
Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received may be posted without change
to https://www.regulations.gov/, including any personal information
provided. For detailed instructions on sending comments and additional
information on the rulemaking process, see the ``Public Participation''
heading of the SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Susan Euling, Drinking Water Science
and Engineering Division, Office of Ground Water and Drinking Water
(Mail Code 4601M), Environmental Protection Agency, 1200 Pennsylvania
Avenue NW, Washington, DC 20460; email address: [email protected]
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Public Participation
A. Written Comments
II. General Information
A. Introduction to the Preliminary Assessment Plan and
Literature Survey for the Fluoride Human Health Toxicity Assessment
B. Next Steps for the Fluoride Human Health Toxicity Assessment
I. Public Participation
A. Written Comments
Submit your comments, identified by Docket ID No. EPA-HQ-OW-2025-
3823, at https://www.regulations.gov (our preferred method), or the
other methods identified in the ADDRESSES section. Once submitted,
comments cannot be edited or removed from the docket. The EPA may
publish any comment received to its public docket. Do not submit to
EPA's docket at https://www.regulations.gov any information you
consider to be Confidential Business Information (CBI), Proprietary
Business Information (PBI), or other information whose disclosure is
restricted by statute. Multimedia submissions (audio, video, etc.) must
be accompanied by a written comment. The written comment is considered
the official comment and should include discussion of all points you
wish to make. The EPA will generally not consider comments or comment
contents located outside of the primary submission (i.e., on the web,
cloud, or other file sharing system). Please visit https://www.epa.gov/dockets/commenting-epa-dockets for additional submission methods; the
full EPA public comment policy; information about CBI, PBI, or
multimedia submissions; and general guidance on making effective
comments.
II. General Information
A. Introduction to the Preliminary Assessment Plan and Literature
Survey for the Fluoride Human Health Toxicity Assessment
The EPA is committed to ensuring clean and safe drinking water for
all Americans with the goal of protecting human health, including
children's health. In response to concerns about fluoride in drinking
water, the EPA is developing a new human health toxicity assessment
that will review scientific information on the potential health risks
of fluoride in drinking water. The toxicity assessment will be based on
a systematic review of the scientific information on the potential
health risks of fluoride in drinking water. The objective of the
toxicity assessment is to determine the fluoride levels that a person
can be exposed to and be unlikely to experience harmful health effects;
these values are called toxicity values, specifically noncancer
reference doses (RfDs).
The Preliminary Assessment Plan and Literature Survey (Assessment
Plan) is the first step in developing the toxicity assessment. The
objectives of the Assessment Plan are to describe the approach the EPA
intends to follow to develop the human health toxicity assessment and
present the results of the preliminary literature survey. The
preliminary literature survey describes the results of conducting
initial systematic review steps to identify relevant health effects
studies, consistent with agency human health risk assessment guidance
and Executive Order 14303 Restoring Gold Standard Science. A summary of
the scoping and problem formulation conclusions is also presented in
the Assessment Plan. As part of scoping and problem formulation, the
EPA identified key science issues specific to fluoride exposure and
health effects measurement that will be evaluated during toxicity
assessment development.
The Assessment Plan is not a toxicity assessment; it does not
contain conclusions regarding harmful human health effects of fluoride
or determine the level of fluoride exposure at or above which is
associated with harmful health effects. The EPA is releasing the
Fluoride Preliminary Assessment Plan and Literature Survey for public
comment to provide transparency and gather early feedback about the
assessment scope and identified literature.
The EPA's fluoride toxicity assessment will evaluate human health
hazards. The fluoride toxicity assessment, once final, can be used by
EPA, states, Tribes, and local communities, along with specific
exposure and other relevant information, to determine, under the
appropriate regulations and statutes, the potential risk associated
with human exposures to fluoride. Specifically, the EPA's toxicity
assessment will be used to inform future decisions about potential
revisions to the existing fluoride drinking water standard under the
Safe Drinking Water Act (SDWA). The results of this toxicity assessment
will also be used to inform Centers for Disease Control and Prevention
(CDC) recommendations regarding fluoride in drinking water (https://
[[Page 3724]]
www.whitehouse.gov/wp-content/uploads/2025/09/The-MAHA-Strategy-
WH.pdf).
B. Next Steps for the Fluoride Human Health Toxicity Assessment
The EPA is accepting public comments on this Assessment Plan for 30
days. The EPA will consider all public comments during the next step in
the toxicity assessment process, which is the development of the
Systematic Review Protocol (protocol). The protocol will present
detailed methods for conducting subsequent steps of the systematic
review. The EPA will then follow the protocol to develop a draft
Fluoride Human Health Toxicity Assessment. The draft toxicity
assessment will follow EPA human health risk assessment methods and
guidance, summarize the health effects associated with exposure to
fluoride during childhood, and identify the fluoride level at or below
which a person can be exposed to and be unlikely to experience harmful
health effects. The draft toxicity assessment will be released for
external peer review and public comment. The EPA will consider the
external peer review and public comments and revise the assessment as
appropriate, before publishing a final Fluoride Human Health Toxicity
Assessment.
Jessica L. Kramer,
Assistant Administrator.
[FR Doc. 2026-01657 Filed 1-27-26; 8:45 am]
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