[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)]
[Notices]
[Page 35811]
[FR Doc No: 2016-13147]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Public Notice For Waiver for Aeronautical Land-Use Assurance at
Pleasanton Municipal Airport, Pleasanton, TX

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice of intent for waiver of aeronautical land-use.

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SUMMARY: The Federal Aviation Administration (FAA) is considering a
proposal to change a portion of the airport from aeronautical use to
nonaeronautical use and to authorize the conversion of the airport
property. The proposal consists of one parcel of land containing a
total of approximately 1.6 acres to be used for a fire station.
Additionally, the change-in-use of 0.19 acres from aeronautical to non-
aeronautical use, approved in 1999 for a fire station that was never
constructed, will now revert back to aeronautical use.
    The property was acquired in 1973 by grant funds. The land
comprising this parcel is outside the forecasted need for aviation
development and, thus, is no longer needed for indirect or direct
aeronautical use. The airport wishes to develop this land for a fire
station. The income from the conversion of this parcel will benefit the
aviation community by reinvestment in the airport.
    Approval does not constitute a commitment by the FAA to financially
assist in the conversion of the subject airport property nor a
determination of eligibility for grant-in-aid funding from the FAA. The
disposition of proceeds from the conversion of the airport property
will be in accordance with FAA's Policy and Procedures Concerning the
Use of Airport Revenue, published in the Federal Register on February
16, 1999. In accordance with Section 47107(h) of Title 49, United
States Code, this notice is required to be published in the Federal
Register 30 days before modifying the land-use assurance that requires
the property to be used for an aeronautical purpose.

DATES: Comments must be received on or before July 5, 2016.

ADDRESSES: Send comments on this document to Mr. Cameron Bryan, Federal
Aviation Administration, Acting Manager, Texas Airports Development
Office, 10101 Hillwood Parkway, Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Mr. Bruce Pearson, City Manager, City
of Pleasanton, P.O. Box 209 Pleasanton, TX 78064, telephone (830) 569-
3867, or Mr. Anthony Mekhail, Federal Aviation Administration, Texas
Airports Development Program Manager, 10101 Hillwood Parkway, Fort
Worth, TX 76177, telephone<PHONE_NUMBER>, FAX<PHONE_NUMBER>.
Documents reflecting this FAA action may be reviewed at the above
locations.

    Issued in Fort Worth, Texas on May 26, 2016.
Ignacio Flores,
Manager, Airports Division, FAA, Southwest Region.
[FR Doc. 2016-13147 Filed 6-2-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 64 (Wednesday, April 3, 2019)]
[Proposed Rules]
[Pages 12975-12979]
[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,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule

    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

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

(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

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


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This comment period is my only opportunity, as a  consumer, to provide my feedback.

I prefer calling e-cigarettes, Personal Vaporizers (PV's) because cigarettes were killing me. I feel very strongly about PV's as an alternative to combustible cigarettes. Quite simply, I firmly believe that PV's saved my life. I wish to provide you with my personal story, as well as science - and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that I and all PV consumers have the opportunity to provide our comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.