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HHS/FDA RIN: 0910-AI03 Publication ID: Spring 2018 
Title: ●Proposed Rule to Revise the Allowable Level of Fluoride Added to Bottled Water 

The proposed rule would revise the quality standard regulations for fluoride in fluoridated bottled water to make them consistent with a 2015 recommendation by the United States Public Health Service (PHS) for optimal fluoride concentration in community water systems.  This action, if finalized, will not affect the allowable levels of fluoride in non-fluoridated bottled water (i.e., bottled water to which fluoride is not added, but which may contain fluoride from its source water).

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Other 
CFR Citation: 21 CFR 165   
Legal Authority: 21 U.S.C. 341    21 U.S.C. 349    21 U.S.C. 371   
Legal Deadline:  None
Action Date FR Cite
NPRM  06/00/2018 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Small Entities Affected: No  Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Yinqing Ma
Supervisory Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
5001 Campus Drive (HFS-317),
College Park, MD 20740
Phone:240 402-2479