23434 Federal Register / Vol. 87, No. 76 / Wednesday, April 20, 2022 / Rules and Regulations 

15A, 8260–15B, when required by an 

entry on 8260–15A, and 8260–15C. 

The large number of SIAPs, Takeoff 

Minimums and ODPs, their complex 

nature, and the need for a special format 

make publication in the Federal 

Register expensive and impractical. 

Further, airmen do not use the 

regulatory text of the SIAPs, Takeoff 

Minimums or ODPs, but instead refer to 

their graphic depiction on charts 

printed by publishers or aeronautical 

materials. Thus, the advantages of 

incorporation by reference are realized 

and publication of the complete 

description of each SIAP, Takeoff 

Minimums and ODP listed on FAA form 

documents is unnecessary. This 

amendment provides the affected CFR 

sections and specifies the typed of 

SIAPS, Takeoff Minimums and ODPs 

with their applicable effective dates. 

This amendment also identifies the 

airport and its location, the procedure, 

and the amendment number. 

Availability and Summary of Material 

Incorporated by Reference 

The material incorporated by 

reference is publicly available as listed 

in the ADDRESSES section. 

The material incorporated by 

reference describes SIAPS, Takeoff 

Minimums and/or ODPs as identified in 

the amendatory language for part 97 of 

this final rule. 

The Rule 

This amendment to 14 CFR part 97 is 

effective upon publication of each 

separate SIAP, Takeoff Minimums and 

ODP as amended in the transmittal. 

Some SIAP and Takeoff Minimums and 

textual ODP amendments may have 

been issued previously by the FAA in a 

Flight Data Center (FDC) Notice to 

Airmen (NOTAM) as an emergency 

action of immediate flights safety 

relating directly to published 

aeronautical charts. 

The circumstances that created the 

need for some SIAP and Takeoff 

Minimums and ODP amendments may 

require making them effective in less 

than 30 days. For the remaining SIAPs 

and Takeoff Minimums and ODPs, an 

effective date at least 30 days after 

publication is provided. 

Further, the SIAPs and Takeoff 

Minimums and ODPs contained in this 

amendment are based on the criteria 

contained in the U.S. Standard for 

Terminal Instrument Procedures 

(TERPS). In developing these SIAPs and 

Takeoff Minimums and ODPs, the 

TERPS criteria were applied to the 

conditions existing or anticipated at the 

affected airports. Because of the close 

and immediate relationship between 

these SIAPs, Takeoff Minimums and 

ODPs, and safety in air commerce, I find 

that notice and public procedure under 

5 U.S.C. 553(b) are impracticable and 

contrary to the public interest and, 

where applicable, under 5 U.S.C. 553(d), 

good cause exists for making some 

SIAPs effective in less than 30 days. 

The FAA has determined that this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current. It, therefore—(1) is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866; (2) is not a 

‘‘significant rule’’ under DOT 

Regulatory Policies and Procedures (44 

FR 11034; February 26, 1979); and (3) 

does not warrant preparation of a 

regulatory evaluation as the anticipated 

impact is so minimal. For the same 

reason, the FAA certifies that this 

amendment will not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

Lists of Subjects in 14 CFR Part 97 

Air traffic control, Airports, 

Incorporation by reference, Navigation 

(air). 

Issued in Washington, DC, on April 1, 

2022. 

Thomas J Nichols, 

Aviation Safety, Flight Standards Service, 

Manager, Standards Section, Flight 

Procedures & Airspace Group, Flight 

Technologies & Procedures Division. 

Adoption of the Amendment 

Accordingly, pursuant to the 

authority delegated to me, Title 14, 

Code of Federal Regulations, part 97 (14 

CRF part 97) is amended by 

establishing, amending, suspending, or 

removing Standard Instrument 

Approach Procedures and/or Takeoff 

Minimums and Obstacle Departure 

Procedures effective at 0901 UTC on the 

dates specified, as follows: 

PART 97—STANDARD INSTRUMENT 

APPROACH PROCEDURES 

■ 1. The authority citation for part 97 

continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g), 40103, 

40106, 40113, 40114, 40120, 44502, 44514, 

44701, 44719, 44721–44722. 

■ 2. Part 97 is amended to read as 

follows: 

Effective 19 May 2022 

Palm Springs, CA, KTRM, RNAV (GPS) 

RWY 35, Amdt 2 

Miami, FL, KMIA, ILS OR LOC RWY 9, 

Amdt 11 

Mapleton, IA, KMEY, RNAV (GPS) RWY 

2, Amdt 1 

Mapleton, IA, KMEY, RNAV (GPS) RWY 

20, Amdt 1 

Olney-Noble, IL, KOLY, LOC RWY 11, 

Amdt 7 

Marion, KY, KGDA, RNAV (GPS) RWY 

7, Amdt 3 

Marion, KY, KGDA, RNAV (GPS) RWY 

25, Amdt 3 

O’Neill, NE, KONL, VOR RWY 13, Amdt 

5F 

O’Neill, NE, KONL, VOR RWY 31, Amdt 

1E 

Berlin, NH, KBML, Takeoff Minimums 

and Obstacle DP, Amdt 3 

Las Vegas, NV, KLAS, ILS OR LOC RWY 

1L, Amdt 4 

Las Vegas, NV, KLAS, RNAV (GPS) 

RWY 1R, Amdt 4 

Las Vegas, NV, KLAS, RNAV (RNP) 

RWY 26R, Amdt 1 

Babelthuap Island, PW, PTRO, NDB 

RWY 9, Orig-B 

Babelthuap Island, PW, PTRO, RNAV 

(GPS) RWY 9, Orig-B 

Babelthuap Island, PW, PTRO, RNAV 

(GPS) RWY 27, Orig-B 

Mc Minnville, TN, KRNC, Takeoff 

Minimums and Obstacle DP, Amdt 3 

Burlington, VT, KBTV, RNAV (GPS) 

RWY 1, Amdt 1 

[FR Doc. 2022–08312 Filed 4–19–22; 8:45 am] 

BILLING CODE 4910–13–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, 

Department of Health and Human 

Services (HHS). 

ACTION: Final rule. 

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 


khammond on DSKJM1Z7X2PROD with RULES
Federal Register / Vol. 87, No. 76 / Wednesday, April 20, 2022 / Rules and Regulations 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 https://

www.regulations.gov 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, David.Whitman@fda.hhs.gov; 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 

§ 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 § 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 


khammond on DSKJM1Z7X2PROD with RULES
23436 Federal Register / Vol. 87, No. 76 / Wednesday, April 20, 2022 / Rules and Regulations 

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 § 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: 

• 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. 

• 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 § 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 § 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). 


khammond on DSKJM1Z7X2PROD with RULES
Federal Register / Vol. 87, No. 76 / Wednesday, April 20, 2022 / Rules and Regulations 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 § 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 

§ 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 § 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 longterm 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 


khammond on DSKJM1Z7X2PROD with RULES
23438 Federal Register / Vol. 87, No. 76 / Wednesday, April 20, 2022 / Rules and Regulations 

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 § 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 


khammond on DSKJM1Z7X2PROD with RULES
Federal Register / Vol. 87, No. 76 / Wednesday, April 20, 2022 / Rules and Regulations 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 °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 § 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 

(§ 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 

§ 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 § 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 

(§ 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 (§ 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 § 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 § 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 

§ 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 


khammond on DSKJM1Z7X2PROD with RULES
23440 Federal Register / Vol. 87, No. 76 / Wednesday, April 20, 2022 / Rules and Regulations 

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 

§ 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 https://www.fda.gov/ 

about-fda/reports/economic-impactanalyses-fda-regulations. 

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 


khammond on DSKJM1Z7X2PROD with RULES
Federal Register / Vol. 87, No. 76 / Wednesday, April 20, 2022 / Rules and Regulations 23441 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they also are 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. FDA, ‘‘Letter to Manufacturers, 

Distributors, or Importers of Bottled 

Water with an Update on Fluoride 

Added to Bottled Water’’ (April 27, 

2015). Available at https://www.fda.gov/ 

food/guidanceregulation/guidance

documentsregulatoryinformation/bottled

watercarbonatedsoftdrinks/ 

ucm444373.htm (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 https://

www.des.nh.gov/sites/g/files/ehbemt341/ 

files/documents/2020-01/dwgb-3-5.pdf 

(accessed March 29, 2022). 

4. Centers for Disease Control and 

Prevention, ‘‘Community Water 

Fluoridation.’’ Available at https://

www.cdc.gov/fluoridation/ 

index.html?CDC_AA_

refVal=https%3A%2F

%2Fwww.cdc.gov%2Ffluoridation

%2Findex.htm (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 https://

www.fda.gov/AboutFDA/ 

ReportsManualsForms/Reports/ 

EconomicAnalyses/default.htm 

(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 

■ 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. Amend § 165.110 by revising 

paragraphs (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 

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 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket No. USCG–2022–0168] 

Special Local Regulations; Conch 

Republic Navy Parade and Battle, Key 

West, FL 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

the special local regulations for the 

Conch Republic Navy Parade and Battle 

in Key West, Florida. Our regulation for 

Recurring Marine Events in Seventh 

Coast Guard District identifies the 

regulated area for this event. During the 

enforcement period no person or vessel 

may enter into, transit through, anchor 

in, or remain within the regulated area 

without approval from the Captain of 

the Port Key West or a designated 

representative. 

DATES: The regulations in 33 CFR 

100.701 will be enforced for the location 

identified in paragraph (b) Item 2 of 

Table 1 to § 100.701, from 7 p.m. until 

8 p.m. on April 22, 2022. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this notice, call 

or email Lieutenant Junior Grade Vera 

Max, Sector Key West Waterways 

Management Division, Coast Guard; 

telephone (305) 292–8768, email 

SKWWaterways@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the special local 

regulations in 33 CFR 100.701, Table 1 

to § 100.701, paragraph (b), Item 2, from 

7 p.m. until 8 p.m. on April 22, 2022 for 

the annual Conch Republic Navy Parade 

and Battle in Key West, Florida. This 

action is being taken to provide for the 

safety of life on the navigable waters of 

the Key West Harbor during the 

simulated battle event. Our regulation 

for Recurring Marine Events within 

Seventh Coast Guard District, § 100.701, 

Table 1 to § 100.701, paragraph (b), Item 

2, specifies the location of the regulated 

area for the reenactment of the battle 

within the Key West Harbor. 

During the enforcement period, as 

reflected in § 100.701, no person or 

vessel may enter, transit through, 

anchor within, or remain within the 

established regulated areas without 

approval from the Captain of the Port 

Key West or designated representative. 

The Coast Guard may be assisted by 

other Federal, State, or local law 

enforcement agencies in enforcing this 

regulation. 

In addition to this notice of 

enforcement in the Federal Register, the 

Coast Guard plans to provide notice of 

this enforcement period via the Local 

Notice to Mariners, Broadcast Notice to 

Mariners, and on-scene designated 

representatives. 

Dated: April 12, 2022. 

Adam A. Chamie, 

Captain, U.S. Coast Guard, Captain of the 

Port Key West. 

[FR Doc. 2022–08423 Filed 4–19–22; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2022–0233] 

RIN 1625–AA00 

Safety Zones; Cape Canaveral, 

Daytona, Tampa, Jacksonville, and 

Tallahassee, Florida 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing five temporary safety zones 

for the reentry of capsules launched by 

Space Exploration Technologies 

Corporation (Space X) in support of the 

Axiom and the National Aeronautics 

and Space Administration (NASA) 

Crew-3 capsule recovery missions. 

These five temporary safety zones are 

located within the Coast Guard District 

Seven area of responsibility offshore of 

Cape Canaveral, Daytona, Jacksonville, 

Tampa, and Tallahassee, Florida. The 

purpose of this rule is to ensure the 

safety of vessels, mariners, and the 

navigable waters in the safety zones 

before, during, and after the scheduled 


khammond on DSKJM1Z7X2PROD with RULES