49234 Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Rules and Regulations 

contains anthocyanins as the principal 

coloring component. 

(2) Color additive mixtures for food 

use made with butterfly pea flower 

extract may contain only those diluents 

that are suitable and are listed in this 

subpart as safe for use in color additive 

mixtures for coloring foods. 

(b) Specifications. Butterfly pea 

flower extract must conform to the 

following specifications and must be 

free from impurities, other than those 

named, to the extent that such other 

impurities may be avoided by good 

manufacturing practice: 

(1) pH, not less than 3.0 and not more 

than 4.5 at 25 °C. 

(2) Lead, not more than 1 milligram 

per kilogram (mg/kg) (1 part per million 

(ppm)). 

(3) Arsenic, not more than 1 mg/kg 

(1 ppm). 

(4) Mercury, not more than 1 mg/kg 

(1 ppm). 

(5) Cadmium, not more than 1 mg/kg 

(1 ppm). 

(c) Uses and restrictions. Butterfly pea 

flower extract may be safely used for 

coloring alcoholic beverages, sport and 

energy drinks, flavored or carbonated 

water, fruit drinks (including smoothies 

and grain drinks), carbonated soft drinks 

(fruit-flavored or juice, ginger ale, and 

root beer), fruit and vegetable juice, 

nutritional beverages, chewing gum, 

teas, coated nuts, liquid coffee creamers 

(dairy and non-dairy), ice cream and 

frozen dairy desserts, hard candy, dairy 

and non-dairy drinks, fruit preparations 

in yogurts, and soft candy in amounts 

consistent with good manufacturing 

practice, except that it may not be used 

for coloring foods for which standards 

of identity have been issued under 

section 401 of the Federal Food, Drug, 

and Cosmetic Act, unless the use of 

added color is authorized by such 

standards. 

(d) Labeling requirements. The label 

of the color additive and any mixtures 

prepared therefrom intended solely or 

in part for coloring purposes must 

conform to the requirements of § 70.25 

of this chapter. 

(e) Exemption from certification. 

Certification of this color additive is not 

necessary for the protection of the 

public health and therefore batches are 

exempt from the certification 

requirements of section 721(c) of the 

Federal Food, Drug, and Cosmetic Act. 

Dated: August 30, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18995 Filed 9–1–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket Number USCG–2021–0426] 

RIN 1625–AA00 

Special Local Regulation; Swim for 

Special Operations Forces; San Diego 

Bay, San Diego, CA 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is amending 

its special local regulations for recurring 

marine parades, regattas, and other 

events in Southern California Annual 

Marine Events for the San Diego Captain 

of the Port Zone. This final rule will add 

one new recurring special local 

regulation. This action is necessary to 

provide for the safety of life on the 

navigable waters during the event. This 

final rule will restrict vessel traffic in 

the designated areas during the events 

unless authorized by the Captain of the 

Port San Diego or a designated 

representative. 

DATES: This rule is effective September 

2, 2021. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2021– 

0426 in the search box and click 

‘‘Search.’’ Next, in the Document Type 

column, select ‘‘Supporting & Related 

Material.’’ 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Lieutenant Commander John 

Santorum, Waterways Management, 

U.S. Coast Guard; telephone 619–278– 

7656, email MarineEventsSD@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

§ Section 

U.S.C. United States Code 

II. Background Information and 

Regulatory History 

On April 8, 2021, The Honor 

Foundation notified the Coast Guard 

that it will be hosting the Honor 

Foundation Swim for Special 

Operations Forces annually on a 

Saturday during the month of 

September. The regulated area would 

cover all navigable waters of the San 

Diego Bay, beginning at Glorietta Bay, 

continuing to Tidelands Park before 

proceeding north along the Coronado 

shoreline, crossing the federal navigable 

channel at Bayview Park, and finishing 

at the USS MIDWAY Museum. 

In response, on July 2, 2021 the Coast 

Guard published a notice of proposed 

rulemaking (NPRM) titled Special Local 

Regulations; Swim for Special 

Operations Forces; San Diego Bay, San 

Diego, CA (86 FR 35240). There we 

stated why we issued the NPRM, and 

invited comments on our proposed 

regulatory action related to this annual 

marine event. During the comment 

period that ended August 2, 2021 we 

received one comment. 

III. Legal Authority and Need for Rule 

The Coast Guard is issuing this rule 

under authority in 46 U.S.C. 70041 

(previously 33 U.S.C. 1231). The 

Captain of the Port San Diego (COTP) 

has determined that potential hazards 

associated with the Honor Foundation 

Swim for Special Operations Forces 

annually on a Saturday during the 

month of September will present a 

safety of life concern on navigatable 

waters. The purpose of this rule is to 

ensure safety of life on the navigable 

waters in the safety zone before, during, 

and after the scheduled event. For the 

reasons stated above, we are issuing this 

rule, and under 5 U.S.C. 553(d)(3), the 

Coast Guard finds that good cause exists 

for making it effective less than 30 days 

after publication in the Federal 

Register. Delaying the effective date of 

this rule would be contrary to the public 

interest because enforcement of this 

safety zone is necessary to protect 

swimmers and vessels from the dangers 

associated with the swim race events 

planned for a Saturday in September 

2021. 

IV. Discussion of Comments, Changes, 

and the Rule 

As noted above, we received one 

comment on the NPRM published July 

2, 2021. The commentor proposed a 

method for intercepting and 

impounding vessels entering the safety 

zone. The Coast Guard was not 

proposing to spcecify how on scene 

representatives must handle situations 

where vessels enter the safety zone in 

this rulemaking. The purpose of this 

rulemaking is to establish the 

reoccurring annual safety zone and its 

location. The Coast Guard has existing 

regulations and policies that cover 

enforcement and this rulemaking does 

not intend to deviate from those 

practices. Accordingly, no changes to 

the regulatory text were made in 

response to this comment. 


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Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Rules and Regulations 49235 

There is one nonsubstantive change in 

the regulatory text from the proposed 

rule to remove a typographical error, 

‘‘SS’’, in the event type. 

This rule establishes a safety zone 

annually on a Saturday in September. 

The safety zone will cover all waters of 

San Diego Bay, from surface to bottom, 

beginning at Glorietta Bay, continuing to 

Tidelands Park, proceeding north along 

the Coronado shoreline, crossing the 

federal navigable channel at Bayview 

Park, and finishing at the USS MIDWAY 

Museum. No vessel or person will be 

permitted to enter the safety zone 

without obtaining permission from the 

COTP or a designated representative. 

V. Regulatory Analyses 

We developed this rule after 

considering numerous statutes and 

Executive orders related to rulemaking. 

Below we summarize our analyses 

based on a number of these statutes and 

Executive orders, and we discuss First 

Amendment rights of protestors. 

A. Regulatory Planning and Review 

Executive Orders 12866 and 13563 

direct agencies to assess the costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits. 

This rule has not been designated a 

‘‘significant regulatory action,’’ under 

Executive Order 12866. Accordingly, 

this rule has not been reviewed by the 

Office of Management and Budget 

(OMB). 

This regulatory action determination 

is based on the size, location, and 

duration of the special local regulation. 

Vessel traffic would be able to safely 

transit around this special local 

regulation, which would impact a smalldesignated area of the San Diego Bay. 

Moreover, the Coast Guard would issue 

a Broadcast Notice to Mariners via 

VHF–FM marine channel 16 about the 

areas, and the rule would allow vessels 

to seek permission to enter the areas. 

B. Impact on Small Entities 

The Regulatory Flexibility Act of 

1980, 5 U.S.C. 601–612, as amended, 

requires Federal agencies to consider 

the potential impact of regulations on 

small entities during rulemaking. The 

term ‘‘small entities’’ comprises small 

businesses, not-for-profit organizations 

that are independently owned and 

operated and are not dominant in their 

fields, and governmental jurisdictions 

with populations of less than 50,000. 

The Coast Guard received no comments 

from the Small Business Administration 

on this rulemaking. The Coast Guard 

certifies under 5 U.S.C. 605(b) that this 

rule will not have a significant 

economic impact on a substantial 

number of small entities. 

While some owners or operators of 

vessels intending to transit the safety 

zone may be small entities, for the 

reasons stated in section V.A above, this 

rule will not have a significant 

economic impact on any vessel owner 

or operator. 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Pub. L. 104–121), 

we want to assist small entities in 

understanding this rule. If the rule 

would affect your small business, 

organization, or governmental 

jurisdiction and you have questions 

concerning its provisions or options for 

compliance, please call or email the 

person listed in the FOR FURTHER

INFORMATION CONTACT section. 

Small businesses may send comments 

on the actions of Federal employees 

who enforce, or otherwise determine 

compliance with, Federal regulations to 

the Small Business and Agriculture 

Regulatory Enforcement Ombudsman 

and the Regional Small Business 

Regulatory Fairness Boards. The 

Ombudsman evaluates these actions 

annually and rates each agency’s 

responsiveness to small business. If you 

wish to comment on actions by 

employees of the Coast Guard, call 

1–888–REG–FAIR (1–888–734–3247). 

The Coast Guard will not retaliate 

against small entities that question or 

complain about this rule or any policy 

or action of the Coast Guard. 

C. Collection of Information 

This rule will not call for a new 

collection of information under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). 

D. Federalism and Indian Tribal 

Governments 

A rule has implications for federalism 

under Executive Order 13132, 

Federalism, if it has a substantial direct 

effect on the States, on the relationship 

between the National Government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. We have 

analyzed this rule under that Order and 

have determined that it is consistent 

with the fundamental federalism 

principles and preemption requirements 

described in Executive Order 13132. 

Also, this rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not 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. 

E. Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Though this rule 

will not result in such an expenditure, 

we do discuss the effects of this rule 

elsewhere in this preamble. 

F. Environment 

We have analyzed this rule under 

Department of Homeland Security 

Directive 023–01, Rev. 1, associated 

implementing instructions, and 

Environmental Planning COMDTINST 

5090.1 (series), which guide the Coast 

Guard in complying with the National 

Environmental Policy Act of 1969 (42 

U.S.C. 4321–4370f), and have 

determined that this action is one of a 

category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule involves a 

regulated area that would prohibit 

persons and vessels from transiting the 

regulated area during the swim event. It 

is categorically excluded from further 

review under paragraph L61 of 

Appendix A, Table 1 of DHS Instruction 

Manual 023–01–001–01, Rev. 1. A 

Record of Environmental Consideration 

supporting this determination is 

available in the docket. For instructions 

on locating the docket, see the 

ADDRESSES section of this preamble. 

G. Protest Activities 

The Coast Guard respects the First 

Amendment rights of protesters. 

Protesters are asked to call or email the 

person listed in the FOR FURTHER

INFORMATION CONTACT section to 

coordinate protest activities so that your 

message can be received without 

jeopardizing the safety or security of 

people, places or vessels. 

List of Subjects in 33 CFR Part 100 

Marine safety, Navigation (water), 

Reporting and recordkeeping 

requirements, Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 100 as follows: 


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49236 Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Rules and Regulations 

PART 100—SAFETY OF LIFE ON 

NAVIGABLE WATERS 

■ 1. The authority citation for part 100 

continues to read as follows: 

Authority: 46 U.S.C. 70041; 33 CFR 1.05– 

1. 

■ 2. In § 100.1101, amend table 1 to 

§ 100.1101, by adding an entry for ‘‘16. 

Swim for Special Operations Forces; 

San Diego Bay, San Diego, CA’’ to read 

as follows: 

§ 100.1101 Southern California Annual 

Marine Events for the San Diego Captain of 

the Port Zone. 

TABLE 1 TO § 100.1101 

*******

16. Swim for Special Operations Forces; San Diego Bay, San Diego, CA 

Sponsor ........................................... The Honor Foundation. 

Event Description ............................ Swim race. 

Date ................................................. Saturday in September. 

Location ........................................... San Diego Bay, CA. 

Regulated Area ............................... All waters of San Diego Bay, from surface to bottom, beginning at Glorietta Bay, continuing to Tidelands 

Park, proceeding north along the Coronado shoreline, crossing the federal navigable channel at Bayview 

Park, and finishing at the USS MIDWAY Museum. 

* * * * * 

Dated: August 27, 2021. 

T.J. Barelli, 

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

Port San Diego. 

[FR Doc. 2021–18955 Filed 9–1–21; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket Number USCG–2021–0653] 

RIN 1625–AA08 

Special Local Regulation; Lighthouse 

Musicfest, Huntington Bay, Long 

Island, NY 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary special local 

regulation of certain navigable waters of 

Huntington Bay, Long Island, NY, for 

the Lighthouse Musicfest marine event. 

This action is necessary to provide the 

safety of life on these navigable waters 

during the event scheduled for 

Saturday, September 4, 2021. This rule 

will allow the Coast Guard to prohibit 

vessel traffic in the vicinity of the event 

and establishes mooring areas and a 

speed restriction in the designated zone. 

DATES: This rule is effective from 9:30 

a.m. through 7:30 p.m. on Saturday, 

September 4, 2021 with a rain date 

effective from 9:30 a.m. through 7:30 

p.m. on Sunday, September 5, 2021. The 

rule will only be subject to enforcement 

from 9:30 a.m. through 7:30 p.m. on 

September 4, 2021, unless the event is 

delayed because of weather conditions 

in which case it may be subject to 

enforcement those same hours on 

September 5, 2021. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2021– 

0653 in the search box and click 

‘‘Search.’’ Next, in the Document Type 

column, select ‘‘Supporting & Related 

Material.’’ 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email MST1 Chris Gibson, Waterways 

Management Division, U.S. Coast 

Guard; telephone 203–468–4565, email 

Chris.A.Gibson@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

COTP Captain of the Port Long Island 

Sound 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

§ Section 

U.S.C. United States Code 

II. Background Information and 

Regulatory History 

The Coast Guard is issuing this 

temporary rule without prior notice and 

opportunity to comment pursuant to 

authority under section 4(a) of the 

Administrative Procedure Act (APA) (5 

U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because it is 

impracticable and contrary to the public 

interest. The event sponsor was late in 

submitting the marine event 

application. This late submission did 

not give the Coast Guard enough time to 

publish an NPRM, take public 

comments, and issue a final rule before 

the effective date. It would be 

impracticable and contrary to the public 

interest to delay promulgating this rule, 

as it is necessary to protect the safety of 

waterway users. Further, the 

expeditious implementation of this rule 

is in the public interest because it will 

help ensure the safety of spectators and 

those involved in the event. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register. Delaying the effective date of 

this rule would be impracticable and 

contrary to the public interest because 

the temporary special local regulation 

must be established on September 4, 

2021 to ensure the safety of spectators 

and vessels during the event. 

III. Legal Authority and Need for Rule 

The Coast Guard is issuing this rule 

under authority in 46 U.S.C. 70034 

(previously 33 U.S.C. 1231). The 

Captain of the Port Long Island Sound 

(COTP) has determined that extra and 

unusual hazards exists for persons or 

vessels operating within the waters of 

Huntington Bay, Long Island, NY with 

the Lighthouse Musicfest marine event. 

This rule is needed to protect personnel, 

vessels, and the marine environment in 

the navigable waters within the special 

local regulated area during the 

Lighthouse Musicfest marine event. 


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