[Federal Register Volume 84, Number 64 (Wednesday, April 3, 2019)]
[Proposed Rules]
[Pages 12975-12979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06201]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 165

[Docket No. FDA-2018-N-1815]
RIN 0910-AI03


Beverages: Bottled Water

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to 
revise the quality standard for bottled water to specify that bottled 
water to which fluoride is added by the manufacturer may not contain 
fluoride in excess of 0.7 milligrams per liter (mg/L). This action, if 
finalized, will revise the current allowable levels for fluoride in 
domestically packaged and imported bottled water to which fluoride is 
added. We are taking this action to make the quality standard 
regulation for fluoride added to bottled water consistent with the 
recommendation by the U.S. Public Health Service (PHS) for community 
water systems that add fluoride for the prevention of dental caries. 
This action, if finalized, will not affect the allowable levels for 
fluoride in bottled water to which fluoride is not added by the 
manufacturer (such bottled water may contain fluoride from its source 
water).

DATES: Submit either electronic or written comments on the proposed 
rule by June 3, 2019.

ADDRESSES: You may submit comments as follows: Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before June 3, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of June 3, 2019. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions.'')

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-1815 for ``Beverages: Bottled Water.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Yinqing Ma, Center for Food Safety and 
Applied Nutrition (HFS-317), Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-2479.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule

[[Page 12976]]

    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Need for the Regulation
    B. FDA's Current Regulatory Framework
IV. Legal Authority
V. Description of the Proposed Rule
VI. Proposed Effective and/or Compliance Dates
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose of the Proposed Rule

    We propose to amend the allowable levels for fluoride in bottled 
water to which fluoride is added, to be consistent with the updated 
recommendation by the PHS on the optimal fluoride concentration in 
community water systems that add fluoride for the prevention of dental 
caries.

B. Summary of the Major Provisions of the Proposed Rule

    The proposed rule would revise the quality standard for bottled 
water (found in Sec.  165.110(b) (21 CFR 165.110(b)) to set the 
allowable level for fluoride at 0.7 mg/L in domestically packaged and 
imported bottled water to which fluoride has been added.

C. Legal Authority

    We are proposing to update the quality standard for bottled water, 
as set forth in this proposed rule, consistent with our authority in 
sections 401, 403, and 701(a) of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) (21 U.S.C. 341, 343, and 371). We discuss our legal 
authority in greater detail in section IV.

D. Costs and Benefits

    The proposed rule, if finalized, would revise the quality standard 
regulations so that the allowable level for fluoride is 0.7 mg/L in 
bottled water to which fluoride has been added, to be consistent with 
the updated PHS recommendation on the optimal level of fluoride in 
community water systems that add fluoride for the prevention of dental 
caries. There would be one-time costs to learn the rule and one-time 
costs to verify the fluoride level after adjustment of the 
manufacturing process for bottled water manufacturers that choose to 
add fluoride to their products. The one-time costs range between 
$129,802.42 and $224,554.41. When discounted at seven percent over 10 
years, the annualized costs range from $18,480.94 and $31,971.50. When 
discounted at three percent over 10 years the annualized costs range 
from $15,216.80 and $26,324.63.

II. Table of Abbreviations and Acronyms Commonly Used in This Document

------------------------------------------------------------------------
          Abbreviation/acronym                    What it means
------------------------------------------------------------------------
EO.....................................  Executive Order.
FDA....................................  Food and Drug Administration.
FD&C Act...............................  Federal Food, Drug, and
                                          Cosmetic Act.
HHS....................................  Department of Health and Human
                                          Services.
IBWA...................................  International Bottled Water
                                          Association.
PHS....................................  U.S. Public Health Service.
------------------------------------------------------------------------

III. Background

A. Need for the Regulation

    In 1973, FDA established standards of quality for bottled water, 
including allowable levels for fluoride, based on the PHS's 1962 
Drinking Water Standards (38 FR 32558, November 26, 1973).
    In adopting the 1962 PHS drinking water standard for fluoride, FDA 
concluded that the addition of fluoride to bottled water should be 
permitted to be consistent with the policy of allowing community water 
fluoridation (38 FR 32558 at 32561, November 26, 1973).
    In 2015, the PHS updated and replaced its 1962 Drinking Water 
Standards related to community water fluoridation and recommended an 
optimal fluoride concentration of 0.7 mg/L. This recommendation is 
published in a Federal Register notice entitled ``Public Health Service 
Recommendation for Fluoride Concentration in Drinking Water for 
Prevention of Dental Caries'' (80 FR 24936, May 1, 2015). In a 2011 
notice proposing the revised fluoride recommendation, the Department of 
Health and Human Services (HHS) explained that the proposed update was 
based on the following information: (1) Community water fluoridation is 
the most cost-effective method of delivering fluoride for the 
prevention of tooth decay; (2) in addition to drinking water, other 
sources of fluoride exposure have contributed to the prevention of 
dental caries and an increase in dental fluorosis prevalence; (3) 
significant caries prevention benefits can be achieved and risk of 
fluorosis can be reduced at 0.7 mg/L, the lowest concentration in the 
range of the then-current PHS recommendation; and (4) recent data do 
not show a convincing relationship between fluid intake and ambient air 
temperature and, therefore, there is no need for different 
recommendations for water fluoride concentrations in different 
temperature zones (76 FR 2383 at 2386, January 13, 2011).
    FDA concludes that the basis for PHS' updated recommendation of 
optimum fluoridation level of 0.7 mg/L in community water is a sound 
public health measure that should also apply to bottled water. Because 
bottled water is increasingly used in some households as a replacement 
for tap water, consumption patterns considered by EPA for community 
water can be used as an estimate for the maximum expected consumption 
of bottled water by some individuals. For example, per capita 
consumption of bottled water in the U.S. increased from 29 gallons in 
2007 to 42.1 gallons in 2017 (Ref. 1).
    Therefore, FDA believes the allowable levels for fluoride in 
bottled water to which fluoride is added based on the PHS's 1962 
Drinking Water Standards are outdated given the 2015 PHS updated 
recommendation (80 FR 24936, May 1, 2015). A regulation is needed to 
revise the FDA quality standard regulations so that the allowable level 
for fluoride is 0.7 mg/L in bottled water to which fluoride has been 
added. This level would be consistent with the updated PHS 
recommendation on the optimal level of fluoride in community water 
systems that add fluoride.

B. FDA's Current Regulatory Framework

    Under the quality standard regulations for bottled water (Sec.  
165.110(b)), we set different allowable levels for fluoride in bottled 
water depending on whether the water is bottled domestically or is 
imported, as well as on whether the fluoride in the bottled water is 
present in the source water or is added by the manufacturer. If a 
manufacturer adds fluoride to bottled water, then the allowable level 
for fluoride is governed by the regulation that applies to bottled 
water to which fluoride is added, regardless of whether some of the 
fluoride was present in the source water.
    For bottled water that is packaged in the United States, we 
described two product types and for each established a range for the 
allowable levels for fluoride based on the annual average maximum daily 
air temperatures at the location where the bottled water is sold at 
retail. These temperature-related allowable levels were based on early 
data that suggested the amount of water (and consequently the amount of

[[Page 12977]]

fluoride) ingested was influenced primarily by air temperature (38 FR 
32558 at 32561). One range (1.4 to 2.4 mg/L) pertains to bottled water 
to which fluoride is not added, and the other range (0.8 to 1.7 mg/L) 
pertains to bottled water to which fluoride is added. For imported 
bottled water, our standards are not temperature-dependent: There is a 
single allowable level for fluoride in bottled water to which fluoride 
is not added (1.4 mg/L), and a single allowable level for fluoride in 
bottled water to which fluoride is added (0.8 mg/L). When establishing 
the current allowable levels for fluoride, we explained that 
manufacturers of imported bottled water do not usually have direct 
control of the retail sale of their product. Therefore, by setting the 
allowable levels for imported bottled water at the lowest concentration 
in the range for each type of domestically bottled water (i.e., 1.4 mg/
L for bottled water with no added fluoride and 0.8 mg/L for bottled 
water with added fluoride), imported bottled water may be sold in any 
location without exceeding the allowable fluoride levels of the 
drinking water standard (39 FR 32558 at 32561, November 26, 1973).
    On April 27, 2015, we issued a letter to industry recommending, 
based on the updated PHS recommendation, that bottled water 
manufacturers not add fluoride to bottled water at concentrations 
greater than a final concentration of 0.7 mg/L (Ref. 2). In our letter, 
we also stated our intent to revise the allowable levels for fluoride 
in bottled water to which fluoride has been added to be consistent with 
the updated PHS recommendation. We did not receive any objections to 
the letter.

IV. Legal Authority

    We are proposing to update the quality standard establishing the 
allowable levels for fluoride in bottled water to which fluoride has 
been added, as set forth in this proposed rule, consistent with our 
authority in sections 401, 403, and 701(a) of the FD&C Act.
    Section 401 of the FD&C Act directs the Secretary of HHS (the 
Secretary) to issue regulations fixing and establishing for any food a 
reasonable definition and standard of identity, quality, or fill of 
container whenever in the judgment of the Secretary such action will 
promote honesty and fair dealing in the interest of consumers.
    Under section 403(h)(1) of the FD&C Act, a food is misbranded if it 
purports to be or is represented as a food for which a standard of 
quality has been prescribed by regulations under section 401, and its 
quality falls below such standard, unless its label bears, in such 
manner and form as such regulations specify, a statement that it falls 
below such standard.
    Under section 701(a) of the FD&C Act, we may issue regulations for 
the efficient enforcement of the FD&C Act to ``effectuate a 
congressional objective expressed elsewhere in the Act'' (Association 
of American Physicians and Surgeons, Inc. v. FDA, 226 F. Supp. 2d 204 
(D.D.C. 2002) (citing Pharm. Mfrs. Ass'n v. FDA, 484 F. Supp. 1179, 
1183 (D. Del. 1980)). Updating this allowable level for fluoride in 
bottled water to be consistent with the updated PHS recommendation 
would help effectuate the congressional objective expressed in sections 
401 and 403 of the FD&C Act.

V. Description of the Proposed Rule

    We propose to revise the bottled water quality standard (Sec. Sec.  
165.110(b)(4)(ii)(C) and (D)) to be consistent with the updated PHS 
recommendation (80 FR 24936, May 1, 2015) by setting 0.7 mg/L as the 
allowable level for fluoride in bottled water to which fluoride is 
added. In addition, consistent with the updated PHS recommendation, we 
also propose to remove references to annual averages of maximum daily 
air temperatures in the current Sec.  165.110(b)(4)(ii)(C), table 2; as 
discussed in the updated PHS recommendation, data do not show a 
convincing relationship between fluid intake and ambient air 
temperature (76 FR 2383 at 2386).
    Therefore, the proposed rule would revise Sec.  
165.110(b)(4)(ii)(C) to specify bottled water packaged in the United 
States to which fluoride is added must not contain fluoride in excess 
of 0.7 mg/L. The proposed rule would revise Sec.  165.110(b)(4)(ii)(C) 
by removing Table 2 and language pertaining to setting fluoride levels 
based on annual averages of maximum daily air temperatures. The 
proposed rule also would revise Sec.  165.110(b)(4)(ii)(D) to specify 
that imported bottled water to which fluoride is added must not contain 
fluoride in excess of 0.7 mg/L. The proposed rule would not affect the 
allowable levels for fluoride in bottled water to which fluoride is not 
added by the manufacturer (but which may contain fluoride from its 
source water, specified in Sec.  165.110(b)(4)(ii)(A) and (B)).

VI. Proposed Effective and/or Compliance Date(s)

    We intend that any final rule resulting from this rulemaking would 
become effective 60 days after the date of the final rule's publication 
in the Federal Register. According to the International Bottled Water 
Association (IBWA), many of its member companies in the United States 
have already adjusted fluoride addition to obtain the 0.7 mg/L fluoride 
in their finished bottled water in response to the updated PHS 
recommendation and FDA's April 27, 2015, letter (Ref. 3). Therefore, we 
propose a compliance date 120 days after the effective date. We believe 
that the time frame for the compliance date is sufficient for bottled 
water manufactures to learn the rule and adjust their processes to 
bring their products into compliance with the new requirement.

VII. Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive 
Order (E.O.) 12866, E.O. 13563, E.O. 13771, the Regulatory Flexibility 
Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 
(Pub. L. 104-4). E.O. 12866 and E.O. 13563 direct us to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). E.O. 13771 requires that the costs associated with significant 
new regulations ``shall, to the extent permitted by law, be offset by 
the elimination of existing costs associated with at least two prior 
regulations.'' This proposed rule is a significant regulatory action as 
defined by E.O. 12866. This proposed rule is expected to be an E.O. 
13771 regulatory action. Details on the estimated costs of this 
proposed rule can be found in the rule's economic analysis.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because updating the standards of the allowable level for 
fluoride in bottled water to which fluoride has been added specified in 
this proposed rule would not significantly increase costs to bottled 
water manufacturers, we propose to certify that the proposed rule will 
not have a significant economic impact on a substantial number of small 
entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more

[[Page 12978]]

(adjusted annually for inflation) in any one year.'' The current 
threshold after adjustment for inflation is $154 million, using the 
most current (2018) Implicit Price Deflator for the Gross Domestic 
Product. This proposed rule would not result in an expenditure in any 
year that meets or exceeds this amount.
    We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the proposed rule. The full analysis of 
economic impacts is available in the docket for this proposed rule 
(Ref. 4) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

Summary of Costs and Benefits

    The proposed rule would revise the standard for the allowable level 
for fluoride to 0.7 mg/L in bottled water to which fluoride has been 
added, a level consistent with the updated U.S. Public Health Service 
(PHS) recommendations for the optimal level of fluoride in community 
water systems to prevent dental caries (tooth decay). There may be some 
health benefits from revising this standard for fluoride in bottled 
water. As stated in the 2011 Department of Health and Human Services 
(HHS) notice proposing the revised recommended fluoride concentration, 
available data suggest that a concentration of 0.7 mg/L provides an 
optimal balance between the prevention of dental caries and the risk of 
dental fluorosis (76 FR 2383 at 2386). Moreover, this may reduce any 
unnecessary confusion on the part of consumers from having the standard 
for fluoride added to bottled water differ from the PHS recommendations 
for community water fluoridation.
    There would be one-time costs to learn the rule for all bottled 
water manufacturers and one-time costs to verify the fluoride level 
after adjustment of the manufacturing process for bottled water 
manufacturers that choose to add fluoride to their product. The one-
time costs range between $129,802.42 and $224,554.41. When discounted 
at seven percent over 10 years, the annualized costs range from 
$18,480.94 and $31,971.50. When discounted at three percent over 10 
years the annualized costs range from $15,216.80 and $26,324.63. In 
Table 1, we provide the Regulatory Information Service Center and 
Office of Information and Regulatory Affairs Consolidated Information 
System accounting information on the annualized costs and benefits of 
the proposed rule.

                                                  Table 1--Economic Data: Costs and Benefits Statement
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                      Units
                                                                                                     ---------------------------------------
                           Category                              Primary        Low          High                                  Period       Notes
                                                                 estimate     estimate     estimate       Year       Discount     covered
                                                                                                        dollars      rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/year......................  ...........  ...........  ...........  ...........            7
                                                                                                                             3
                                                              ------------------------------------------------------------------------------------------
    Annualized Quantified....................................  ...........  ...........  ...........  ...........            7
                                                                                                                             3
                                                              ------------------------------------------------------------------------------------------
    Qualitative..............................................  Update standard to make consistent
                                                               with current PHS recommendations.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/year......................       $0.025       $0.018       $0.032         2017            7           10
                                                                    $0.021       $0.015       $0.026         2017            3           10
    Annualized Quantified....................................  ...........  ...........  ...........  ...........            7
                                                                                                                             3
    Qualitative..............................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized $millions/year..............  ...........  ...........  ...........  ...........            7
                                                                                                                             3
                                                              ------------------------------------------------------------------------------------------
                                                               From:
                                                               To:
                                                              ------------------------------------------------------------------------------------------
    Other Annualized Monetized $millions/year................  ...........  ...........  ...........  ...........            7
                                                                                                                             3
                                                              ------------------------------------------------------------------------------------------
                                                               From:
                                                               To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: No effect........................................................................................................
    Small Business: No effect...........................................................................................................................
    Wages: No estimated effect..........................................................................................................................
    Growth: No estimated effect.........................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In table 2 we show a summary of the costs, cost savings and net 
costs. This proposed rule, if finalized, is considered an E.O. 13771 
regulatory action.

                                 Table 2--E.O. 13771 Summary (in $ Millions 2016 Dollars) Over an Infinite Time Horizon
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Lower bound     Upper bound                     Lower bound     Upper bound
                                                           Primary (7%)        (7%)            (7%)        Primary (3%)        (3%)            (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs..................................          $0.177          $0.130          $0.225          $0.177          $0.130          $0.225
Present Value of Cost Savings...........................               0               0               0               0               0               0
Present Value of Net Costs..............................           0.177           0.130           0.225           0.177           0.130           0.225

[[Page 12979]]

 
Annualized Costs........................................          0.0124          0.0091          0.0157          0.0053          0.0039          0.0067
Annualized Cost Savings.................................               0               0               0               0               0               0
Annualized Net Costs....................................          0.0124          0.0091          0.0157          0.0053          0.0039          0.0067
--------------------------------------------------------------------------------------------------------------------------------------------------------

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.32(m) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

X. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in E.O. 13132. We have determined that this rule 
has federalism impacts as it amends the standard of quality regulations 
for bottled water. The existing standard of quality is not new and 
already preempts state laws because it is within the scope of section 
403A of the FD&C Act, an express preemption provision.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in E.O. 13175. We have tentatively determined that 
the rule does not contain policies that would have a substantial direct 
effect on one or more Indian Tribes, on the relationship between the 
Federal Government and Indian Tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian Tribes. 
We invite comments from tribal officials on any potential impact on 
Indian Tribes from this proposed action.

XII. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. Rodwan, J.G. Jr., ``Bottled Water. U.S. and International 
Developments & Statistics,'' (https://www.bottledwater.org/public/BMC2017_BWR_StatsArticle.pdf), Bottled Water Reporter, pp. 12-20, 
July/August, 2018.
2. FDA, ``Letter to Manufacturers, Distributors, or Importers of 
Bottled Water with an Update on Fluoride Added to Bottled Water,'' 
(https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/bottledwatercarbonatedsoftdrinks/ucm444373.htm), April 27, 2015
3. FDA Memorandum, ``Teleconference Related to Fluoride in Bottled 
Water,'' 2016.
4. FDA, ``Proposed Rule to Revise the Allowable Level of Fluoride in 
Bottled Water to which Fluoride Has Been Added, Preliminary 
Regulatory Impact Analysis, Initial Regulatory Flexibility Analysis, 
Unfunded Mandates Reform Act Analysis,'' (https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm).

List of Subjects in 21 CFR Part 165

    Beverages, Bottled water, Food grades and standards, Incorporation 
by reference.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, we propose 
that 21 CFR part 165 be amended as follows:

PART 165--BEVERAGES

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 21 U.S.C. 321, 341, 343, 343-1, 348, 349, 371, 379e.

0
2. Revise Sec.  165.110(b)(4)(ii)(C) and (D) to read as follows:


Sec.  165.110   Bottled water.

* * * * *
    (b) * * *
    (4) * * *
    (ii) * * *
    (C) Bottled water packaged in the United States to which fluoride 
is added must not contain fluoride in excess of 0.7 milligram per 
liter.
    (D) Imported bottled water to which fluoride is added must not 
contain fluoride in excess of 0.7 milligram per liter.
* * * * *

    Dated: March 26, 2019.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2019-06201 Filed 4-2-19; 8:45 am]
 BILLING CODE 4164-01-P


