Rule2022-08273
Beverages: Bottled Water
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 20, 2022
Effective
June 21, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is revising 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), which available data suggests provides an optimal balance between the prevention of dental caries and the risk of dental fluorosis. This final rule revises the current allowable levels, which range from 0.8 to 1.7 mg/L, 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 2015 recommendation by the U.S. Public Health Service (PHS) for community water systems that add fluoride for the prevention of dental caries. This action 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).
Full Text
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<title>Federal Register, Volume 87 Issue 76 (Wednesday, April 20, 2022)</title>
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[Federal Register Volume 87, Number 76 (Wednesday, April 20, 2022)]
[Rules and Regulations]
[Pages 23434-23441]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08273]
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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, Department of Health and Human
Services (HHS).
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA or we) is revising 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), which available data
suggests provides an optimal balance between the prevention of dental
caries and the risk of dental fluorosis. This final rule revises the
current allowable levels, which range from 0.8 to 1.7 mg/L, for
fluoride in domestically packaged and imported bottled water to which
fluoride is added. We are taking this action to make
[[Page 23435]]
the quality standard regulation for fluoride added to bottled water
consistent with the 2015 recommendation by the U.S. Public Health
Service (PHS) for community water systems that add fluoride for the
prevention of dental caries. This action 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: This rule is effective June 21, 2022. The compliance date is
October 17, 2022.
ADDRESSES: For access to the docket to read background documents or
comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.
FOR FURTHER INFORMATION CONTACT: David Whitman, Center for Food Safety
and Applied Nutrition (HFS-820), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-3754,
<a href="/cdn-cgi/l/email-protection#a2e6c3d4cbc68cf5cacbd6cfc3cce2c4c6c38ccacad18cc5cdd4"><span class="__cf_email__" data-cfemail="763217001f1258211e1f021b171836101217581e1e0558111900">[email protected]</span></a>; or Deirdre Jurand, Center for Food Safety
and Applied Nutrition, Office of Regulations and Policy (HFS-024), Food
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-2378.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Major Provisions of the Final Rule
C. Legal Authority
D. Costs and Benefits
II. Background
A. Need for the Regulation/History of This Rulemaking
B. Summary of Comments to the Proposed Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
A. Introduction
B. Description of General Comments and FDA Response
C. Comments on the Level of Added Fluoride in Bottled Water and
FDA Response
D. Comment on the Health Effects of Added Fluoride and FDA
Response
E. Comment on the Compliance Date and FDA Response
F. Miscellaneous Comments and FDA Response
V. Effective/Compliance Dates
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments
XI. References
I. Executive Summary
A. Purpose of the Final Rule
We are amending 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 Final Rule
The final rule revises 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
This final rule updates the quality standard for bottled water,
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(a)). We discuss our legal authority in greater detail in
section III.
D. Costs and Benefits
This final rule revises 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, which is consistent with the current PHS
recommendation on the optimal level of fluoride in community water
systems that add fluoride for the prevention of dental caries. We
estimate that there will be one-time costs to read and understand 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 $214,370.26 and $333,338.24.
When discounted at 7 percent over 10 years, the annualized costs range
from $30,521.50 to $47,459.87. When discounted at 3 percent over 10
years the annualized costs range from $25,130.73 to $39,077.41.
II. Background
A. Need for the Regulation/History of This Rulemaking
In 1973, FDA established standards of quality for bottled water,
including allowable levels for fluoride, based on the PHS' 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). For bottled water to which fluoride is added that
is packaged in the United States, FDA established as the allowable
level a range (0.8 to 1.7 mg/L) based on the annual average maximum
daily air temperatures at the location where the bottled water is sold
at retail. For imported bottled water, we established a single
allowable level for fluoride in bottled water to which fluoride is
added (0.8 mg/L).
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). The same
year, 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. 1). 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, and
bottled water manufacturer input indicates that most bottled water to
which fluoride has been added that is sold or offered for sale in the
United States, whether domestic or imported, now has no more than 0.7
mg/L fluoride (Ref. 2).
In the Federal Register of April 3, 2019, we issued a proposed rule
to amend the quality standard for bottled water (found in Sec.
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 (84 FR 12975) (``proposed rule''). We explained the basis
for the PHS's 2015 optimal fluoride concentration recommendation for
drinking water, concluded that the basis is a sound public health
measure that should also apply to bottled water, and noted that
amending the allowable level for fluoride in bottled water to which
fluoride had been added to 0.7 mg/L would be consistent with the
updated PHS fluoride recommendation. We also
[[Page 23436]]
stated that 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
(84 FR 12975 at 12978).
In addition, consistent with the updated PHS recommendation, we
proposed to remove references to annual averages of maximum daily air
temperatures in Sec. 165.110(b) because, as discussed in the updated
PHS recommendation, data do not show a convincing relationship between
fluid intake and ambient air temperature (84 FR 12975 at 12977).
We also proposed that the final rule be effective 60 days after the
date of the final rule's publication in the Federal Register and a
compliance date 120 days after the effective date.
B. Summary of Comments to the Proposed Rule
The proposed rule provided a 60-day comment period. We received
more than 90 comments. The comments came from individuals, academia,
healthcare professionals, consumer advocacy groups, research
associations, and industry trade associations. Among other things, the
comments discussed:
<bullet> The level of added fluoride that should be in bottled
water. Many comments supported our proposed level, but some opposed the
addition of any fluoride to bottled water or supported an amount less
than 0.7 mg/L. Additionally, some comments suggested that consumers
should be able to choose between bottled water with and without added
fluoride. Other comments suggested that we should do our own studies or
consider additional research.
<bullet> The health effects of added fluoride to water. While some
comments agreed that the proposed level would help prevent dental
caries, some other comments expressed concern that the ingestion of
fluoride could have adverse health effects, such as dental fluorosis,
skeletal fluorosis, neurological toxicity, endocrine disruption, and
lower IQ.
III. Legal Authority
We are updating the quality standard establishing the allowable
levels for fluoride in bottled water to which fluoride has been added,
as set forth in this final 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 the Department
of Health and Human Services (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 of the
FD&C Act, 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.
IV. Comments on the Proposed Rule and FDA Response
A. Introduction
We received no comments on our proposal to remove references to
annual averages of maximum daily air temperatures in Sec. 165.110(b)
and are finalizing it without change. We received more than 90 comments
on other provisions of the proposed rule, and each comment discussed
one or more issues. The comments came from individuals, academia,
healthcare professionals, consumer advocacy groups, research
associations, and industry trade associations.
We describe and respond to the comments in sections B through F of
this section. We have numbered each comment to help distinguish between
different comments. We have grouped similar comments together under the
same number, and, in some cases, we have separated different issues
discussed in the same comment and designated them as distinct comments
for purposes of our responses. The number assigned to each comment or
comment topic is purely for organizational purposes and does not
signify the comment's value or importance or the order in which
comments were received.
B. Description of General Comments and FDA Response
Many comments made general remarks supporting or opposing the
proposed rule without focusing on a particular proposed provision. In
the following paragraphs, we discuss and respond to such general
comments.
(Comment 1) Many comments expressed general support for the
proposed rule. A few comments stated that the proposed rule, if
finalized, would provide consistency between domestically packaged and
imported bottled water.
(Response 1) We proposed to revise, and are revising, the allowable
level for fluoride to 0.7 mg/L in bottled water to which fluoride has
been added, a level consistent with the current PHS recommendations for
the optimal level of fluoride in community water systems to prevent
dental caries. The revised allowable level is consistent between
domestically packaged and imported 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). The PHS confirmed this in 2015 (80 FR 24936).
(Comment 2) A few comments advocated the availability of both
fluoridated and non-fluoridated bottled water so that consumers have
choices. One comment stated that FDA should not ask all bottlers to
fluoridate to the 2015 PHS recommended level of 0.7 mg/L. Another said
that consumers have a right to be aware of the content of their
drinking water, and so FDA should require manufacturers who add
fluoride to their water to label the amount added.
(Response 2) Our final rule revises the allowable level for
fluoride to 0.7 mg/L for bottled water to which fluoride is added.
Manufacturers are not required to fluoridate their water, or to
fluoridate to a level of 0.7 mg/L. Instead, our regulations, at Sec.
165.110(a)(1), provide that fluoride may be optionally added up to the
allowable level.
Consumers can examine bottled water labeling to determine whether
fluoride has been added. In the preamble to the 1995 final rule
establishing the standard of identity and standard of quality for
bottled water, we explained that bottled water with added fluoride
would be a multi-ingredient food and, as such, its label must bear
ingredient labeling (60 FR 57076 at 57079, November 13, 1995).
[[Page 23437]]
If fluoride is added to bottled water, it must be declared in the
ingredients list (21 CFR 101.4(a)(1)). In addition, the terms
``fluoridated,'' ``fluoride added,'' or ``with added fluoride'' may be
used on the label or in labeling of bottled water that contains added
fluoride (21 CFR 101.13(q)(8)). Finally, our regulations, at Sec.
101.9(c)(5) (21 CFR 101.9(c)(5)), require the label declaration of
fluoride in certain circumstances and allow for it voluntarily in all
other cases.
While labeling the amount of fluoride added to bottled water is
outside the scope of this rule, we note that mandatory declaration of
the amount of fluoride is required if a claim about fluoride content is
made on the label or in the labeling of foods (see Sec. 101.9(c)(5)).
We also addressed this in the preamble to our 2016 final rule entitled
``Food Labeling: Revision of the Nutrition and Supplement Facts
Labels'' (81 FR 33742, May 27, 2016) (Nutrition Facts Label final
rule). We declined to require the declaration of fluoride because,
among other reasons, fluoride is a nonessential nutrient, a daily
reference intake cannot be established based on available quantitative
intake recommendations, and total fluoride intake can come from sources
other than bottled water (81 FR 33742 at 33881).
(Comment 3) Some comments stated that FDA should not rely on the
PHS recommendation and FDA should provide its own scientific
justification for the fluoride level in the proposed rule. A few others
asked FDA to review studies published on the safety of fluoride and
community water fluoridation after the 2015 PHS recommendation.
(Response 3) We disagree with the comments stating that FDA should
not rely on the PHS recommendation. In the preamble to the proposed
rule, we explained the basis for the PHS's 2015 recommendation and
concluded that the basis is a sound public health measure that should
also apply to bottled water to which fluoride is added. Furthermore,
the PHS recommended 0.7 mg/L fluoride after systematic reviews of
existing science by a Federal interdepartmental, interagency panel of
scientists, including scientists from FDA (76 FR 2383, January 13,
2011; 80 FR 24936, May 1, 2015). This is consistent with our approach
in 1973, when we established the allowable levels for fluoride in
bottled water based on the PHS's 1962 Drinking Water Standards. At that
time we also concluded that the addition of fluoride to bottled water
should be permitted to be consistent with the policy of community water
fluoridation (38 FR 32558 at 32561). We also believe this will help
promote honesty and fair dealing in the interest of consumers under
section 401 of the FD&C Act (21 U.S.C. 341) in that consumers may
expect the levels of fluoride added to bottled water to be consistent
with the levels of fluoride in public drinking water.
We recognize that additional studies on the safety of fluoride have
published since the publication of the 2015 PHS recommendation. We do
not believe these studies contradict the PHS recommendation, and
neither these studies nor the body of literature we have reviewed show
adverse health effects of fluoride in humans up to the level we are
finalizing. The PHS recommendation has not changed, and we maintain
that the addition of fluoride to bottled water should be permitted to
be consistent with the policy of community water fluoridation. Given
that the comments provided no new information indicating the need to
duplicate the scientific evaluation already conducted by PHS, we are
revising the allowable level for fluoride in bottled water to which
fluoride is added based on the 2015 PHS recommendation.
(Comment 4) Some comments opposed the addition of any fluoride to
bottled water. A few stated that fluoride is a contaminant, poison, or
an industrial waste product, and suggested that our adoption of an
optimal fluoride concentration, or use of the term ``optimal,'' is an
endorsement of fluoridation or encourages the fluoridation of bottled
water. Some comments listed possible adverse health effects of water
fluoridation, such as dental fluorosis, skeletal fluorosis,
neurological toxicity, endocrine disruption, and lower IQ. Some stated
that the prevention of dental caries by ingesting fluoride does not
have adequate scientific support and topical application of fluoride
through toothpaste or mouthwash, or by a dentist, is a better way to
prevent dental caries.
(Response 4) As an initial matter, we consider fluoride to be a
nutrient. As stated in our response to comment 3, the addition of
fluoride to bottled water should be permitted to be consistent with the
PHS recommended level of community water fluoridation, and the PHS
recommendation is a sound public health measure that should also apply
to bottled water to which fluoride is added. The PHS recommendation
addressed the potential for dental fluorosis as well as concerns about
other adverse effects from water fluoridation (80 FR 24936 at 24940
through 24942). The PHS recommendation also addressed the concerns
regarding the safety of fluoride additives (80 FR 24936 at 24942
through 24943). The comments did not provide, and we are not aware of,
evidence that fluoride added to bottled water up to 0.7 mg/L is a
contaminant or poison, or that fluoride is an industrial waste product.
Regarding the comments suggesting that this rule endorses or
encourages bottled water fluoridation, we note in our response to
comment 2 that the rule does not require manufacturers to fluoridate
their water, or to fluoridate to a level of 0.7 mg/L. Instead, our
regulations, at Sec. 165.110(a)(1), provide that fluoride may be
optionally added up to the allowable level. We also note that we are
not adopting or identifying an optimum fluoride level for bottled water
to which fluoride has been added, and we maintain that the addition of
fluoride to bottled water should be consistent with the policy of
community water fluoridation.
Regarding the ingestion of fluoride, we recognize that consumers
are also exposed to fluoride from other sources. The PHS considered the
availability of other fluoride-containing products, including
toothpastes, mouth rinses, and professionally applied fluoride
compounds, when establishing the 0.7 mg/L optimum level for community
water fluoridation (80 FR 24936 at 24937 through 24938). The PHS also
stated that community water fluoridation is a major factor responsible
for the decline of the prevalence and severity of dental caries during
the second half of the 20th century, and that, when analyses were
limited to studies conducted after the introduction of other sources of
fluoride, especially fluoride toothpaste, beneficial effects across the
lifespan from community water fluoridation were still apparent (80 FR
24936 at 24937).
(Comment 5) One comment supported the proposal but asked whether
the reduction of the amount of added fluoride in bottled water will
have any other unforeseen long-term effects on the population.
(Response 5) The comment did not provide, and we are not aware of,
any information regarding unforeseen long-term effects on the
population of a 0.7 mg/L fluoride limit in bottled water to which
fluoride is added.
C. Comments on the Level of Added Fluoride in Bottled Water and FDA
Response
(Comment 6) Some comments that supported the proposed rule
specifically supported the proposed level of 0.7 mg/L and stated that
the level is consistent with public health
[[Page 23438]]
recommendations, FDA guidance, and current industry practice.
(Response 6) As we noted in our response to comment 1, we proposed
to 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 PHS recommendations. As stated in the 2011 HHS notice
proposing the revised recommended fluoride concentration, available
data suggest that a fluoride 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, or different standards for
domestically packaged and imported bottled water.
(Comment 7) One comment said that there is no need for this rule
because there is no immediate danger in the levels of fluoride in
bottled water.
(Response 7) We disagree that there is no need for this rule or
that an ``immediate danger'' is needed to take this action. This final
rule is consistent with our authority in sections 401, 403, and 701(a)
of the FD&C Act. We have concluded 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.
When we adopted the 1962 PHS drinking water standard for fluoride,
we 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). In addition, this rule 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, or different
standards for domestically packaged and imported bottled water.
(Comment 8) Some comments asked FDA to regulate the level of
fluoride naturally present in bottled water. A few comments
specifically asked FDA to reduce the allowable levels for naturally
occurring fluoride to 0.7 mg/L, and a few others indicated that FDA
should not permit the sale of bottled water with natural fluoride
concentrations above 0.7 mg/L.
(Response 8) The regulation of bottled water to which no fluoride
is added is outside the scope of this rule. Our regulations, at Sec.
165.110(b)(4)(ii)(A) and (B), limit the amount of fluoride in domestic
and imported bottled water to which no fluoride is added. Those levels
range from 1.4 to 2.4 mg/L. Our current revision of the allowable
levels of fluoride in bottled water is based on the 2015 PHS
recommendation, which does not affect community water systems with
naturally occurring fluoride in water at concentrations greater than
0.7 mg/L (80 FR 24936 at 24937). Therefore, we are not revising the
allowable levels for fluoride in bottled water to which fluoride has
not been added by the manufacturer.
We note that the maximum fluoride level we are finalizing limits
the total amount of fluoride that may be present in bottled water to
which fluoride is added--that is, the sum of added and naturally
occurring fluoride amounts in bottled water to which fluoride is added
may not exceed 0.7 mg/L.
(Comment 9) Several comments expressed concern that even if the
amount of added fluoride is safe, the final fluoride level in bottled
water to which fluoride is added may be unsafe because either: (a) The
water to which fluoride is added may already contain fluoride; or (b)
ingestion of both fluoridated community water and bottled water to
which fluoride is added would lead to fluoride overconsumption.
(Response 9) As we noted in our response to comment 8, the maximum
fluoride level we are finalizing limits the total amount of fluoride
that may be present in bottled water to which fluoride is added--that
is, the sum of added and naturally occurring fluoride amounts in
bottled water to which fluoride is added may not exceed 0.7 mg/L. The
regulation of bottled water to which no fluoride is added (which may
contain naturally occurring fluoride) and of municipal water is outside
the scope of this rule. However, the PHS considered the availability of
other fluoride-containing products when establishing the 0.7 mg/L
optimum level for community water fluoridation (80 FR 24936 at 24937).
(Comment 10) One comment recommended a level of 0.6 mg/L and cited
the recommendation from the New Hampshire Department of Environmental
Services (NH DES) (Ref. 3).
(Response 10) The NH DES recommends a drinking water fluoride level
of 0.6 to 0.8 mg/L. It references the Centers for Disease Control and
Prevention (CDC) community water fluoridation website (Ref. 4), which
further references the 2015 U.S. PHS recommended level of 0.7 mg/L. As
such, the NH DES's recommendation is consistent with the 2015 PHS
recommendation. The comment did not provide other information to
support the 0.6 mg/L level. Therefore, we are not revising the
allowable level to 0.6 mg/L.
(Comment 11) One comment asked FDA to create an acceptable range of
fluoride for the purposes of compliance with the rule, because such a
range would appropriately recognize that: (a) Adding fluoride to
bottled water is not an exact process; and (b) existing FDA regulations
require added minerals to be present at least at the level declared on
the label. The comment stated that this type of operational flexibility
is needed because the level of fluoride in a bottled water product with
added fluoride will be subject to some variation, consistent with good
manufacturing practices. The comment said that, if the proposed rule is
finalized without the requested range for compliance, the rule would
appear to create a paradox with respect to compliance with two sets of
FDA regulations: (1) This rule, which establishes 0.7 mg/L as the
maximum or ceiling for bottled water to which fluoride is added; and
(2) the FDA compliance standard for nutrition labeling, which
establishes the declared level as the minimum or floor by requiring a
composite sample tested for an added mineral like fluoride to contain
the mineral at least 100 percent of the declared level. The comment
specifically asked FDA to establish a range of 0.6 to 1.0 mg/L for
fluoride in bottled water intended for children 4 years and older and
adults, and a separate range of 0.4 to 0.7 mg/L for fluoride in bottled
water intended for infants and toddlers under 4 years of age.
(Response 11) We decline to create a compliance range and are
finalizing the revision of the standard for the allowable level for
fluoride to 0.7 mg/L in bottled water to which fluoride has been added.
We recognize that there are potential variabilities in adding
fluoride in bottled water during manufacturing and variabilities during
fluoride measurement. We also recognize that the CDC proposed an
operational control range of 0.6 to 1.0 mg/L in community water systems
that adjust fluoride (83 FR 32666, July 13, 2018). The proposed range
is based on the ability of community water systems to stay successfully
within a particular operational control range (83 FR 32666 at 32667).
The comment did not provide information on fluoride variations within
community water systems that are applicable to a bottled water
manufacturing environment or to
[[Page 23439]]
support the requested compliance ranges. Additionally, we have no
information, and received no comments, suggesting that some current
single-level fluoride standards that have no compliance range (e.g.,
0.8 mg/L for bottled water to which fluoride is added and that is at an
annual average of maximum daily air temperature between 79.3 to 90.5
[deg]F) have posed unreasonable challenges to the bottled water
industry.
We agree that our regulations require added minerals to be present
at least at the level declared on the label. Our regulations, at Sec.
101.9(g)(4)(i), state that a food with a label declaration of, among
other things, a mineral that meets our definition of a Class I nutrient
is misbranded under section 403(a) of the FD&C Act unless its nutrient
content is formulated to be at least equal to the value for that
nutrient declared on the label. We explained in the Nutrition Facts
Label final rule that we consider fluoride to be a nutrient, and
specifically, a mineral (81 FR 33742 at 33883). Added fluoride is a
Class I nutrient for nutrition labeling purposes because it is an added
nutrient in fortified or fabricated foods (Sec. 101.9(g)(3)(i)).
A label declaration is required if a claim about fluoride content
is made on the label or in the labeling of foods (see Sec.
101.9(c)(5)). Our regulations would require the fluoride levels in such
products to be at least at the level declared on the label. That
minimum fluoride level is not incompatible with the fluoride level
finalized in this rule. We understand that, to account for process
variability, industry may formulate to a slightly higher fluoride
content to ensure the impacted products consistently meet the minimum
requirement for nutrient declaration as described in Sec.
101.9(g)(4)(i). We expect that the slight overage of fluoride used to
account for process variability is small and would be consistent with
current good manufacturing practice (Sec. 101.9(g)(6)). In addition,
an FDA sample for nutrient analysis consists of a composite of 12
subsamples (consumer units), with one sample taken from each of 12
different randomly chosen shipping cases, to be representative of a lot
(Sec. 101.9(g)(2)). FDA conducts nutrient analyses using appropriate
methods as given in the Official Methods of Analysis of the AOAC
International (id.). Therefore, our sampling procedure for compliance
purposes already takes into account the sample variabilities within a
lot. Furthermore, as discussed in our response to comment 2, bottled
water manufacturers that fluoridate their water are not required to
fluoridate to a level of 0.7 mg/L--lower levels are permitted. A
bottled water manufacturer could target a fluoridation level below 0.7
mg/L, and, even with the slight overage consistent with current good
manufacturing practices, we would expect the finished product to be in
compliance with both the labeling requirement in Sec. 101.9(g)(4)(i)
and the allowable level for fluoride finalized in this rule.
D. Comment on the Health Effects of Added Fluoride and FDA Response
(Comment 12) A few comments expressed concern that dental fluorosis
could occur in infants who consume infant formula reconstituted with
fluoridated bottled water.
(Response 12) The PHS considered this when they issued their 2015
recommendation. They stated that, if an infant is consuming only infant
formula mixed with fluoridated water, there may be an increased chance
for permanent teeth to have mild dental fluorosis (80 FR 24936 at 24940
through 24941). To lessen this chance, parents may choose to use low-
fluoride bottled water some of the time to mix infant formula, e.g.,
bottled waters labeled as deionized, purified, demineralized, or
distilled, and without any fluoride added after purification treatment
(80 FR 24936 at 24940). However, the PHS concluded that their
recommendation to lower the fluoride concentration for community water
fluoridation should decrease fluoride exposure during the time of
enamel formation, from birth through 8 years of age for most permanent
teeth, and further lessen the chance for children's teeth to have
dental fluorosis, while keeping the decay prevention benefits of
fluoridated water (80 FR 24936). We expect the same balance between the
prevention of dental caries and the risk of dental fluorosis from
consumption of bottled water to which fluoride is added because this
rule revises the allowable fluoride level in those products to be
consistent with the 2015 PHS recommendation. The comments provided no
new information on this topic, and we agree with PHS' analysis.
As discussed in our response to comment 2, fluoride added to
bottled water must be declared in the ingredient list in accordance
with Sec. 101.4. Consumers can examine bottled water labeling to
determine whether fluoride has been added by, for instance, noting the
type of bottled water (e.g., purified) and reading the ingredient
declaration (i.e., for whether fluoride is listed as an ingredient).
E. Comment on the Compliance Date and FDA Response
(Comment 13) One comment expressed concern over bottled water
manufactured prior to the effective date of the final rule. It asked
whether these products can continue to be sold, and if these products
would impact consumer health. The comment suggested FDA state publicly
that bottled water produced under the current standard will not
adversely influence consumers health so that the consumer can keep
buying in the period between the effective date and the compliance
date. The comment also stated that the proposed compliance date of 120
days after the effective date is too tight for large companies, which
may need a longer time to adjust all of their fluoridated water
products.
(Response 13) The comment provided, and we are aware of, no
information suggesting that that there will be product remaining in
inventories that does not comply with the rule after the compliance
date, and that large companies may need a longer time to adjust their
fluoridated products. We stated in the proposed rule that many bottled
water manufacturers in the United States have already adjusted their
addition of fluoride to obtain the 0.7 mg/L fluoride in their finished
bottled water in response to the updated 2015 PHS recommendation and
FDA's April 27, 2015, letter to manufacturers, distributors or
importers of bottled water (84 FR 12975 at 12977). We received no
comments from bottled water manufacturers or industry groups expressing
concerns with inventory remaining after the compliance date. Therefore,
we do not expect any significant amount of bottled water products to
which fluoride has been added and whose fluoride are at levels above
0.7 mg/L to remain in inventory after the compliance date. We are
finalizing the effective and compliance dates as proposed. With regard
to the comment's question about the impact on public health of bottled
water manufactured prior to this rule's effective date that meets the
previous quality standard for added fluoride, we do not have safety
concerns. We note that any such bottled water would be misbranded if it
did not comply with the label statement requirements under Sec.
165.110(c).
F. Miscellaneous Comments and FDA Response
Many comments addressed aspects of fluoride other than the
allowable level in bottled water to which fluoride is added. Some
aspects, such as allowable
[[Page 23440]]
fluoride levels in municipal water systems, the price of bottled water,
and other substances that we could consider requiring or allowing in
bottled water, are outside the scope of the rule, and we will not
address them here.
We discuss the other miscellaneous comments in the following
paragraphs.
(Comment 14) One comment said that too many children, especially
infants, are ingesting too much fluoride. The comment said that the
warning statement ``Do Not Use Fluoridated Water For Infants or Making
Formula'' must be placed on fluoridated water, and the warning
statement ``For Adult Use Only'' should be placed on fluoridated water.
(Response 14) As discussed in our response to comment 2, fluoride
added to bottled water must be declared in the ingredient list in
accordance with Sec. 101.4. Consumers can examine bottled water
labeling to determine whether fluoride has been added by, for instance,
noting the type of bottled water (e.g., purified) and reading the
ingredient declaration (i.e., for whether fluoride is listed as an
ingredient). Parents may choose whether to give fluoridated bottled
water to children and whether to use bottled water with added fluoride
to mix infant formula. Additionally, as we explained in our response to
comment 12, the level we are finalizing balances the prevention of
dental caries and the risk of dental fluorosis from consumption of
bottled water to which fluoride is added. The comment provided no new
information on this topic. Therefore, we decline to revise the rule as
suggested by the comment.
(Comment 15) One comment asked whether the determination about
Indian Tribal Governments in the proposed rule has changed.
(Response 15) In the proposed rule, we tentatively concluded 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.
Our tentative conclusion has not changed. The comment did not provide
any information that would cause us to reexamine or alter our tentative
conclusion.
V. Effective/Compliance Dates
Effective date: This rule is effective June 21, 2022.
Compliance date: The compliance date of this final rule is October
17, 2022.
VI. Economic Analysis of Impacts
We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 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).
This final rule has been designated by the Office of Information and
Regulatory Affairs as a significant regulatory action as defined by
Executive Order 12866.
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 final rule will not significantly increase costs to bottled water
manufacturers, we certify that the final 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 issuing ``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 $158
million, using the most current (2020) Implicit Price Deflator for the
Gross Domestic Product. This final rule will not result in an
expenditure in any year that meets or exceeds this amount.
The rule revises the bottled water quality 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 PHS
recommendations for the optimal level of fluoride in community water
systems to prevent dental caries (tooth decay).
There will be one-time costs to read and understand 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 $214,370.26 and $333,338.24.
When discounted at 7 percent over 10 years, the annualized costs range
from $30,521.50 to $47,459.87. When discounted at 3 percent over 10
years the annualized costs range from $25,130.73 to $39,077.41.
We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (Ref. 5) and at
<a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.
VII. 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.
VIII. Paperwork Reduction Act of 1995
This final 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.
IX. Federalism
We have analyzed this final rule in accordance with the principles
set forth in Executive Order 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.
X. Consultation and Coordination With Indian Tribal Governments
We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects 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. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive order and, consequently, a
tribal summary impact statement is not required.
XI. References
The following references are on display at the Dockets Management
Staff (see ADDRESSES) and are available for
[[Page 23441]]
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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. FDA, ``Letter to Manufacturers, Distributors, or Importers of
Bottled Water with an Update on Fluoride Added to Bottled Water''
(April 27, 2015). Available at <a href="https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/bottledwatercarbonatedsoftdrinks/ucm444373.htm">https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/bottledwatercarbonatedsoftdrinks/ucm444373.htm</a> (accessed March 29,
2022).
2. International Bottled Water Association Communication to H. Kim,
FDA, Letter, 6/15/2018.
3. New Hampshire Department of Environmental Services, Environmental
Fact Sheet: Fluoride in Drinking Water (2020). Available at <a href="https://www.des.nh.gov/sites/g/files/ehbemt341/files/documents/2020-01/dwgb-3-5.pdf">https://www.des.nh.gov/sites/g/files/ehbemt341/files/documents/2020-01/dwgb-3-5.pdf</a> (accessed March 29, 2022).
4. Centers for Disease Control and Prevention, ``Community Water
Fluoridation.'' Available at <a href="https://www.cdc.gov/fluoridation/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Ffluoridation%2Findex.htm">https://www.cdc.gov/fluoridation/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Ffluoridation%2Findex.htm</a> (accessed March 29, 2022).
5. FDA, ``Final Rule to Revise the Allowable Level of Fluoride in
Bottled Water to which Fluoride Has Been Added, Economic Analysis of
Impacts, Regulatory Flexibility Analysis, Unfunded Mandates Reform
Act Analysis.'' Available at <a href="https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm">https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm</a> (accessed
March 29, 2022).
List of Subjects in 21 CFR Part 165
Beverages, Bottled water, Food grades and standards.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 165 is 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. Amend Sec. 165.110 by revising paragraphs (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: April 8, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-08273 Filed 4-19-22; 8:45 am]
BILLING CODE 4164-01-P
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