Beverages: Bottled Water, 12975-12979 [2019-06201]
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Federal Register / Vol. 84, No. 64 / Wednesday, April 3, 2019 / Proposed Rules
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Dated: March 28, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06436 Filed 4–2–19; 8:45 am]
BILLING CODE 4164–01–P
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.
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
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SUMMARY:
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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.’’
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12975
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
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• Confidential Submissions—To
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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
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copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
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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
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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/201523389.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
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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
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 ..................
FDA ................
FD&C Act .......
HHS ...............
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 § 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.
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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.
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IBWA ..............
PHS ................
Executive Order.
Food and Drug Administration.
Federal Food, Drug, and
Cosmetic Act.
Department of Health and
Human Services.
International Bottled Water
Association.
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-
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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
(§ 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
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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 temperaturedependent: 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
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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 (§§ 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
§ 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 § 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
§ 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
§ 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 § 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
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12977
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
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(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
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.
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.
TABLE 1—ECONOMIC DATA: COSTS AND BENEFITS STATEMENT
Units
Primary
estimate
Low
estimate
High
estimate
Year dollars
Benefits:
Annualized Monetized $millions/year ................................
....................
....................
....................
....................
7
3
Annualized Quantified ........................................................
....................
....................
....................
....................
7
3
Qualitative ..........................................................................
Update standard to make consistent with
current PHS recommendations.
Category
Costs:
Annualized Monetized $millions/year ................................
Annualized Quantified ........................................................
Discount
rate
(%)
Period
covered
(years)
$0.025
$0.021
....................
$0.018
$0.015
....................
$0.032
$0.026
....................
2017
2017
....................
7
3
7
3
....................
....................
....................
....................
7
3
Notes
10
10
Qualitative.
Transfers:
Federal Annualized Monetized $millions/year ...................
From:
Other Annualized Monetized $millions/year ......................
To:
....................
....................
....................
From:
....................
7
3
To:
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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
Primary
(7%)
Present Value of Costs ............................
Present Value of Cost Savings ................
Present Value of Net Costs .....................
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Lower bound
(7%)
$0.177
0
0.177
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Upper bound
(7%)
$0.130
0
0.130
Fmt 4702
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Primary
(3%)
$0.225
0
0.225
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$0.177
0
0.177
03APP1
Lower bound
(3%)
$0.130
0
0.130
Upper bound
(3%)
$0.225
0
0.225
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TABLE 2—E.O. 13771 SUMMARY (IN $ MILLIONS 2016 DOLLARS) OVER AN INFINITE TIME HORIZON—Continued
Primary
(7%)
Annualized Costs .....................................
Annualized Cost Savings .........................
Annualized Net Costs ..............................
0.0124
0
0.0124
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.
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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
VerDate Sep<11>2014
16:58 Apr 02, 2019
Jkt 247001
Lower bound
(7%)
Upper bound
(7%)
0.0091
0
0.0091
0.0157
0
0.0157
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/
guidancedocumentsregulatory
information/bottledwater
carbonatedsoftdrinks/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
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.
2. Revise § 165.110(b)(4)(ii)(C) and (D)
to read as follows:
■
§ 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
PO 00000
Frm 00026
Fmt 4702
Sfmt 4702
Primary
(3%)
Lower bound
(3%)
0.0053
0
0.0053
Upper bound
(3%)
0.0039
0
0.0039
0.0067
0
0.0067
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
DEPARTMENT OF THE INTERIOR
Office of Surface Mining Reclamation
and Enforcement
30 CFR Part 935
[SATS No. OH–260–FOR; Docket ID: OSM–
2018–0001; S1D1S SS08011000 SX064A000
190S180110; S2D2S SS08011000
SX064A000 19XS501520]
Ohio Regulatory Program
Office of Surface Mining
Reclamation and Enforcement, Interior.
ACTION: Proposed rule; public comment
period and opportunity for public
hearing on proposed amendment.
AGENCY:
We, the Office of Surface
Mining Reclamation and Enforcement
(OSMRE), are announcing receipt of a
proposed amendment to the Ohio
regulatory program (the Ohio program)
under the Surface Mining Control and
Reclamation Act of 1977 (SMCRA or the
Act). Through this proposed
amendment, Ohio seeks to revise its
program to require permit applications
to list all unabated ‘‘violation notices,’’
as that term is defined in the approved
program. This change is necessary to be
consistent with the Federal regulations.
This document gives the times and
locations that the Ohio program and this
proposed amendment to that program
are available for your inspection, the
comment period during which you may
submit written comments on the
amendment, and the procedures that we
will follow for the public hearing, if one
is requested.
DATES: We will accept written
comments on this amendment until 4:00
p.m., Eastern Daylight Time (e.d.t.), May
3, 2019. If requested, we will hold a
public hearing on the amendment on
April 29, 2019. We will accept requests
SUMMARY:
E:\FR\FM\03APP1.SGM
03APP1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
