49230 Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Rules and Regulations 

(b)(2) of this section, this date will be 

extended accordingly. If FNS 

determines that the report in the first 

sentence of this paragraph (b)(4) does 

not sufficiently justify the case’s 

pending status, the case shall be 

considered overdue. Depending upon 

the number of overdue cases, FNS may 

find the State agency’s QC system to be 

inefficient or ineffective and suspend 

and/or disallow the State agency’s 

Federal share of administrative funds in 

accordance with the provisions of 

§ 276.4. 

* * * * * 

Cynthia Long, 

Acting Administrator, Food and Nutrition 

Service. 

[FR Doc. 2021–18743 Filed 9–1–21; 8:45 am] 

BILLING CODE 3410–30–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 73 

[Docket No. FDA–2018–C–4117] 

Listing of Color Additives Exempt 

From Certification; Butterfly Pea 

Flower Extract 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

amending the color additive regulations 

to provide for the safe use of an aqueous 

extract of butterfly pea flower (Clitoria 

ternatea) as a color additive in various 

food categories at levels consistent with 

good manufacturing practice. We are 

taking this action in response to a color 

additive petition (CAP) submitted by 

Exponent, Inc., on behalf of Sensient 

Colors, LLC (Sensient). 

DATES: This rule is effective October 5, 

2021. See section X for further 

information on the filing of objections. 

Submit either electronic or written 

objections and requests for a hearing on 

the final rule by October 4, 2021. 

ADDRESSES: You may submit objections 

and requests for a hearing as follows. 

Please note that late, untimely filed 

objections will not be considered. 

Electronic objections must be submitted 

on or before October 4, 2021. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until 11:59 p.m. Eastern Time at the end 

of October 4, 2021. Objections received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic objections in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Objections submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

objection will be made public, you are 

solely responsible for ensuring that your 

objection does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

objection, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit an objection 

with confidential information that you 

do not wish to be made available to the 

public, submit the objection as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper objections 

submitted to the Dockets Management 

Staff, FDA will post your objection, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–C–4117 for ‘‘Listing of Color 

Additives Exempt From Certification; 

Butterfly Pea Flower Extract.’’ Received 

objections, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

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

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit an objection with confidential 

information that you do not wish to be 

made publicly available, submit your 

objections only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ We 

will review this copy, including the 

claimed confidential information, in our 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Stephen DiFranco, Center for Food 

Safety and Applied Nutrition, Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740–3835, 240– 

402–2710. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

In a notification published in the 

Federal Register of November 13, 2018 

(83 FR 56258), we announced that we 

filed a color additive petition (CAP 

8C0313) submitted by Sensient Colors, 

LLC, c/o Exponent, Inc., 1150 

Connecticut Avenue NW, Suite 1100, 

Washington, DC 20036. The petition 

proposed to amend the color additive 

regulations in part 73 (21 CFR part 73), 

‘‘Listing of Color Additives Exempt from 

Certification,’’ to provide for the safe 

use of an aqueous extract of butterfly 

pea flower (Clitoria ternatea) as a color 


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Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Rules and Regulations 49231 

1The proposed scope was subsequently amended 

to include all alcoholic beverages. 

additive in: (1) Alcoholic beverages 

(liquor, liqueurs, and flavored alcoholic 

beverages); 1 (2) ready-to-drink nonalcoholic beverages; (3) liquid coffee 

creamers (dairy and non-dairy); (4) ice 

cream and frozen dairy desserts; (5) fruit 

preparation in yogurt; (6) chewing gum; 

(7) coated nuts; (8) hard candy; and (9) 

soft candy, at levels consistent with 

good manufacturing practice (GMP). 

The petition describes butterfly pea 

flower extract as a dark blue watersoluble extract derived from the flower 

petals of Clitoria ternatea. 

II. Background 

The color additive that is subject of 

this petition is the dark blue liquid 

produced through the water extraction 

of the dried flower petals of Clitoria 

ternatea, commonly known as the 

butterfly pea plant. Butterfly pea flower 

extract contains 42 to 62 percent water, 

22 to 43 percent carbohydrates, and 8 to 

12 percent proteins. The principal 

coloring components in butterfly pea 

flower extract are anthocyanins, mainly 

delphinidin derivatives. The extract also 

contains flavonols, mainly quercetin 

and kaempferol derivatives as minor 

components. These anthocyanins and 

flavonols are naturally present in 

various fruits and vegetables commonly 

consumed in the U.S. diet (Ref. 1). 

The color additive is manufactured by 

sourcing dried flowers of Clitoria 

ternatea. An infusion is prepared by 

adding demineralized water to the 

flower petals, which is separated from 

the plant mass via filtration. The 

butterfly pea flower extract is further 

processed by ultrafiltration to remove 

any residues of plant products greater 

than 2,500 daltons (Da). The extract is 

then concentrated to a standardized 

liquid with an anthocyanin content of 

approximately 2 percent and 

pasteurized. Citric acid may be added to 

control the pH of the extract (Ref. 2). 

The petitioner proposed 

specifications for butterfly pea flower 

extract of less than 1 milligram per 

kilogram (mg/kg) (1 part per million 

(ppm)) of arsenic, less than 1 mg/kg 

(1 ppm) of cadmium, less than 1 mg/kg 

(1 ppm) of lead, and less than 1 mg/kg 

(1 ppm) of mercury, and pH 3.75 ± 0.75 

in the butterfly pea flower extract. Upon 

consideration of the data in the petition 

and other information available to FDA, 

we amended the proposed specification 

for pH to not less than 3.0 and not more 

than 4.5 at 25 °C (Ref. 2). 

The petitioner manufactures the 

extract starting with butterfly pea 

flowers grown without the use of added 

pesticide substances. The petition 

provides data to support its assertion 

that no detectable levels of 340 

substances commonly used as pesticide 

are found in the finished extract. The 

flowers were analyzed using the 

California Department of Food and 

Agriculture multi-residue pesticide 

analysis (Ref. 3). 

Currently, there are no residual 

pesticide tolerance levels for Clitoria 

ternatea codified by the U.S. 

Environmental Protection Agency in 40 

CFR part 180. In cases where no 

tolerance levels are set, the allowable 

residual pesticide levels that may 

remain on the raw agricultural 

commodity are zero (40 CFR 180.5). 

Under section 402(a)(2)(B) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 342(a)(2)(B)), 

food is adulterated if it bears or contains 

pesticide chemical residue that is unsafe 

within the meaning of section 408(a) of 

the FD&C Act (21 U.S.C. 346a(a)). 

III. Safety Evaluation 

Under section 721(b)(4) of the FD&C 

Act (21 U.S.C. 379e(b)(4)), a color 

additive may not be listed for a 

proposed use unless the data and 

information available to FDA establish 

that the color additive is safe for that 

use. Our color additive regulations at 21 

CFR 70.3(i) define ‘‘safe’’ to mean that 

there is convincing evidence 

establishing with reasonable certainty 

that no harm will result from the 

intended use of the color additive. 

To determine whether a color additive 

is safe under the general safety clause, 

the FD&C Act requires FDA to conduct 

a fair evaluation of the available data 

and consider, among other relevant 

factors: (1) Probable consumption of, or 

other relevant exposure from, the 

additive and of any substance formed in 

or on food, drugs or devices, or 

cosmetics because of the use of the 

additive; (2) cumulative effect, if any, of 

such additive in the diet of man or 

animals, taking into account chemically 

or pharmacologically related substance 

or substances in such diet; and (3) safety 

factors recognized by experts ‘‘as 

appropriate for the use of animal 

experimentation data’’ (see section 

721(b)(5)(A) through (C) of the FD&C 

Act). 

As part of our safety evaluation to 

establish with reasonable certainty that 

a color additive is not harmful under its 

intended conditions of use, we consider 

the additive’s manufacturing and 

stability; the projected human dietary 

exposure to the additive and any 

impurities resulting from the petitioned 

use of the additive; the additive’s 

toxicological data; and other relevant 

information (such as published 

literature) available to us. 

IV. Safety of Petitioned Use of the Color 

Additive 

A. Exposure Estimate 

The petitioner requested that butterfly 

pea flower extract be permitted at levels 

consistent with GMP and provided the 

maximum use levels for the color 

additive, representing GMP, for each 

proposed food use (Ref. 4). The 

petitioner used food consumption data 

from the 2011–2014 National Health 

and Nutrition Examination Survey 

(NHANES) to estimate exposure to 

butterfly pea flower extract from the 

proposed uses. Upon further 

clarification of the proposed uses to 

include all alcoholic beverages (Ref. 5), 

we amended the petitioner’s exposure 

estimate to include all alcoholic 

beverages (Ref. 4). 

Using food consumption data from 

the 2011–2014 NHANES, we estimated 

the eaters-only exposure to butterfly pea 

flower extract to be 198 milligrams per 

person per day (198 mg/p/d) at the 

mean and 453 mg/p/d at the 90th 

percentile for the U.S. population aged 

2 years and older and 56 mg/p/d at the 

mean and 118 mg/p/d at the 90th 

percentile for children 2 to 5 years of 

age (Ref. 4). 

The petition indicated that butterfly 

pea flower extract could contain up to 

2 percent anthocyanins (by weight). 

Assuming a maximum of 2 percent, we 

estimated the dietary exposure to 

anthocyanins from the proposed uses to 

be 4 mg/p/d at the mean and 9 mg/p/ 

d at the 90th percentile for the U.S. 

population 2 years of age and older (Ref. 

4). Because delphinidin was stated to be 

the principal anthocyanin in butterfly 

pea flower extract, the exposure to 

anthocyanins represents the exposure to 

delphinidin from the proposed uses of 

butterfly pea flower extract. 

Similarly, we estimated the dietary 

exposure to quercetin resulting from the 

proposed uses of butterfly pea flower 

extract. The petition indicates that 

butterfly pea flower contains 

approximately 3 percent (by weight) of 

flavonols, which are comprised of 

various quercetin and kaempferol 

derivatives. We conservatively 

presumed that all the flavonols present 

in butterfly pea flower extract were 

present as quercetin (see below) and 

estimated quercetin exposure to be 6 

mg/p/d at the mean and 14 mg/p/d at 

the 90th percentile for the U.S. 

population 2 years of age and older (Ref. 

4). 


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49232 Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Rules and Regulations 

B. Toxicological Considerations 

To establish that butterfly pea flower 

extract is safe for use as a color additive 

for the proposed uses, the petitioner 

used a weight-of-evidence approach 

based on: (1) Toxicological information 

about the extract’s major coloring 

component, delphinidin, including a 

2013 European Food Safety Authority 

(EFSA) review of anthocyanins (Ref. 6); 

(2) a 28-day subacute range finding 

feeding study in rats; (3) a 90-day 

feeding study in rats; (4) a bacterial 

reverse mutation test and an in vitro 

micronucleous test addressing possible 

mutagenicity and genotoxicity of 

butterfly pea flower extract; (5) an in 

vivo somatic mutation and 

recombination test conducted on the 

unprocessed butterfly pea flower parts; 

(6) in vivo genotoxicity data from 

published literature on anthothyanins 

(including delphinidin) and flavonol 

components (Refs. 7 and 8); (7) clinical 

human studies of anthocyanins 

(including delphinidin) and spray-dried 

butterfly pea flower extract; (8) clinical 

studies of quercetin and kaempferol, the 

primary flavonols present; (9) a 

proteomic assessment of butterfly pea 

flower extract aimed at establishing that 

cyclotides found in the tissues of 

Clitoria ternatea are not present in the 

butterfly pea flower extract; and (10) an 

allergenicity assessment of butterfly pea 

flower extract. 

We reviewed the oral toxicity studies 

and agree with the petitioner’s 

conclusions that the no observed 

adverse effect level in the 90-day study 

is the highest dose tested (3,500 mg/kg/ 

d of butterfly pea flower extract), which 

is nearly 500-fold of the 90th percentile 

daily exposure for U.S. population 2 

years and older (Ref. 9). While chronic 

studies were not provided by the 

petitioner nor available from the 

published literature, we believe that 

chronic toxicity from the intended use 

of butterfly pea flower extract is 

unlikely because: (1) We did not 

identify any potential toxicity effects 

associated with the use of either 

butterfly pea flower extract or its 

anthocyanins and flavonol components 

from literature that warrant further 

chronic toxicity studies (Refs. 9 and 10); 

(2) the systemic oral absorption of 

anthocyanins and flavonols is generally 

low (Ref. 9); (3) there are available 

human clinical studies indicating that 

the main anthocyanins and flavonol 

components of butterfly pea flower 

extract are well tolerated in humans 

(Ref. 9); and (4) anthocyanins and 

flavonols are naturally present and 

widely distributed in many plants used 

as food, and the exposures to 

anthocyanins and flavonols from the use 

of butterfly pea flower extract were 

estimated to be comparable or lower 

than the exposure from a typical diet 

(Ref. 11). 

We also did not find any scientific 

data suggesting reproductive or 

developmental toxicity; moreover, the 

genotoxicity studies demonstrate that 

butterfly pea flower extract is nonmutagenic and non-genotoxic (Ref. 9). 

Based on the totality of evidence and 

a weight of evidence analysis that 

considered the lack of overall 

genotoxicity, mode of action, and the 

level of exposure, we conclude that 

butterfly pea flower extract is not likely 

to pose a carcinogenic risk to humans at 

its intended use levels (Refs. 9 and 10). 

Among the available relevant clinical 

studies, one study of butterfly pea 

flower extract indicated no acute 

adverse effect at doses up to 2 grams per 

person. Other clinical studies, using 

either anthocyanins or flavonols, 

suggested tolerance at doses much 

higher than the exposure level from the 

consumption of butterfly pea flower 

extract under the intended condition of 

use (Ref. 9). 

The petitioner provided analytical 

evidence demonstrating that the 

cyclotides identified in butterfly pea 

flower petals were not detected in the 

butterfly pea flower extract. Therefore, 

there is no toxicity concern for 

cyclotides from the consumption of the 

extract (Ref. 9). 

Although there is no evidence in the 

scientific literature specifically 

suggesting that either Clitoria ternatea 

flowers or the coloring component 

delphinidin is associated with allergic 

or hypersensitive reactions, we note that 

butterfly pea flower extract contains 8 to 

12 percent protein by weight. To 

address the allergenicity potential of 

butterfly pea flower extract, the 

petitioner provided bioinformatic 

analyses of the 193 protein sequences of 

Clitoria ternatea identified in the 

National Center for Biotechnology 

Information protein database. These 

protein sequences were compared for 

similarity with the known allergenic 

protein sequences collected in the 

AllergenOnline database (Ref. 12). The 

analysis revealed five protein sequence 

matches (defined as 35 percent or higher 

identity over an 80-amino-acid sliding 

window); however, these proteins are 

expected to be over 5,000 Da and not 

likely to pass through the 2,500 Da 

ultrafiltration system used in the 

manufacturing process. To mitigate the 

possible risk that allergenic proteins and 

other large peptides might pose, our 

regulation at 21 CFR 73.69(a)(1) requires 

that the aqueous extract used to produce 

the color additive undergo 

ultrafiltration. We agree with the 

petitioner that the totality of the 

evidence supports the conclusion that it 

is extremely unlikely that the proteins 

in butterfly pea flower extract could act 

as allergens (Ref. 9). 

V. Conclusion 

Based on the data and information in 

the petition and other available relevant 

information, we conclude that the 

petitioned use of butterfly pea flower 

extract as a color additive in: Alcoholic 

beverages, sport and energy drinks, 

flavored or carbonated water, fruit 

drinks (including smoothies and grain 

drinks), carbonated soft drinks (fruitflavored 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 is safe, 

provided the amount of butterfly pea 

flower extract does not exceed levels 

consistent with good manufacturing 

practice. 

We further conclude that this color 

additive will achieve its intended 

technical effect and is suitable for the 

petitioned use. Therefore, we are 

amending the color additive regulations 

in part 73 to provide for the safe use of 

this color additive as set forth in this 

document. In addition, based on the 

factors in 21 CFR 71.20(b), we conclude 

that batch certification of butterfly pea 

flower extract is not necessary to protect 

the public health. 

VI. Public Disclosure 

In accordance with § 71.15 (21 CFR 

71.15), the petition and the documents 

that we considered and relied upon in 

reaching our decision to approve the 

petition will be made available for 

public disclosure (see FOR FURTHER

INFORMATION CONTACT). As provided in 

§ 71.15, we will delete from the 

documents any materials that are not 

available for public disclosure. 

VII. Analysis of Environmental Impact 

As stated in the November 13, 2018, 

Federal Register notification of filing, 

the petitioner claimed that this action is 

categorically excluded under § 25.32(k) 

(21 CFR 25.32(k)) because butterfly pea 

flower extract would be added directly 

to food and is intended to remain in the 

food through ingestion by consumers 

and is not intended to replace 

macronutrients in food. We further 

stated that if FDA determines a 

categorical exclusion applies, neither an 

environmental assessment nor an 


lotter on DSK11XQN23PROD with RULES1
Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Rules and Regulations 49233 

environmental impact statement is 

required. We did not receive any new 

information or comments regarding this 

claim of categorical exclusion. We 

considered the petitioner’s claim of 

categorical exclusion and determined 

that this action is categorically excluded 

under § 25.32(k). 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. Section 301(ll) of the FD&C Act 

Our review of this petition was 

limited to section 721 of the FD&C Act. 

This final rule is not a statement 

regarding compliance with other 

sections of the FD&C Act. For example, 

section 301(ll) of the FD&C Act (21 

U.S.C. 331(ll)) prohibits the 

introduction or delivery for introduction 

into interstate commerce of any food 

that contains a drug approved under 

section 505 of the FD&C Act (21 U.S.C. 

355), a biological product licensed 

under section 351 of the Public Health 

Service Act (42 U.S.C. 262), or a drug or 

biological product for which substantial 

clinical investigations have been 

instituted and their existence has been 

made public, unless one of the 

exemptions in section 301(ll)(1) to (4) of 

the FD&C Act applies. In our review of 

this petition, we did not consider 

whether section 301(ll) of the FD&C Act 

or any of its exemptions apply to food 

containing this color additive. 

Accordingly, this final rule should not 

be construed to be a statement that a 

food containing this color additive, if 

introduced or delivered for introduction 

into interstate commerce, would not 

violate section 301(ll) of the FD&C Act. 

Furthermore, this language is included 

in all color additive final rules that 

pertain to food and therefore should not 

be construed to be a statement of the 

likelihood that section 301(ll) of the 

FD&C Act applies. 

X. Objections 

This rule is effective as shown in the 

DATES section, except as to any 

provisions that may be stayed by the 

filing of proper objections. If you will be 

adversely affected by one or more 

provisions of this regulation, you may 

file with the Dockets Management Staff 

(see ADDRESSES) either electronic or 

written objections. You must separately 

number each objection, and within each 

numbered objection you must specify 

with particularity the provision(s) to 

which you object, and the grounds for 

your objection. Within each numbered 

objection, you must specifically state 

whether you are requesting a hearing on 

the particular provision that you specify 

in that numbered objection. If you do 

not request a hearing for any particular 

objection, you waive the right to a 

hearing on that objection. If you request 

a hearing, your objection must include 

a detailed description and analysis of 

the specific factual information you 

intend to present in support of the 

objection in the event that a hearing is 

held. If you do not include such a 

description and analysis for any 

particular objection, you waive the right 

to a hearing on the objection. 

Any objections received in response 

to the regulation may be seen in the 

Dockets Management Staff between 9 

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

Friday, and will be posted to the docket 

at https://www.regulations.gov. We will 

publish notice of the objections that we 

have received or lack thereof in the 

Federal Register. 

XI. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (see 

ADDRESSES) and are available for 

viewing by interested persons between 

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

Friday; they also are available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. 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. *Wu, X., G. R. Beecher, J. M. Holden, et 

al., ‘‘Concentrations of Anthocyanins in 

Common Foods in the United States and 

Estimation of Normal Consumption.’’ Journal 

of Agricultural and Food Chemistry, 54: 

4069–4075, 2006. 

2. *Memorandum from B. Petigara Harp, 

Color Technology Branch, Division of Color 

Certification and Technology, Office of 

Cosmetics and Colors, Center for Food Safety 

and Applied Nutrition (CFSAN), FDA, to S. 

DiFranco, Division of Food Ingredients (DFI), 

Office of Food Additive Safety (OFAS), 

CFSAN, FDA, June 4, 2021. 

3. Lee, S. M., M. L. Papathakis, H–M. C. 

Feng, et al., ‘‘Multipesticide Residue Method 

for Fruits and Vegetables: California 

Department of Food and Agriculture.’’ 

Fresenius’ Journal of Analytical Chemistry, 

339, 376–383, 1991. 

4. *Memorandum from D. Doell, Chemistry 

Review Team, DFI, OFAS, CFSAN, FDA, to 

S. DiFranco, DFI, OFAS, CFSAN, FDA, June 

7, 2021. 

5. *Memorandum of Teleconference from 

S. DiFranco, Regulatory Review Team, DFI, 

OFAS, CFSAN, FDA, to the file, April 7, 

2020. 

6. *EFSA, ‘‘Scientific Opinion on the Reevaluation of Anthocyanins (E163) as a Food 

Additive.’’ EFSA Journal, 11(4): 3145, 2013. 

7. *NTP, ‘‘Toxicology and Carcinogenesis 

Studies of Quercetin (CAS No. 117–39–5) in 

F344 Rats (Feed Studies).’’ NTP Technical 

Report Series, No. 409, 1992. 

8. Hard, G. C., J. C. Seeley, L. J. Betz, et 

al., ‘‘Re-evaluation of the Kidney Tumors and 

Renal Histopathology Occurring in a 2-Year 

Rat Carcinogenicity Bioassay of Quercetin.’’ 

Food and Chemical Toxicology, 45: 600–608, 

2007. 

9. *Memorandum from Y. Zang, 

Toxicology Review Team, DFI, OFAS, 

CFSAN, FDA, to S. DiFranco, DFI, OFAS, 

CFSAN, FDA, June 9, 2021. 

10. *Memorandum from S. Mog and S. 

Francke to Y. Zang. Pathology Consultation 

Review on Renal Neoplasms in Male F344 

rats from National Toxicology Program 

Technical Report (NTP TR 409) on Quercetin 

in F344/N Rats (feed studies), October 31, 

2019. 

11. *USDA. ‘‘Table 1a. Flavonoids from 

Food and Beverages: Mean Intake (standard 

error) per Individuals, by Gender and Age, in 

the United States, What We Eat in America.’’ 

NHANES 2007–2010, 2016. 

12. Goodman R. E., M. Ebisawa, F. Ferreira, 

et al., ‘‘AllergenOnline: A Peer-reviewed, 

Curated Allergen Database to Assess Novel 

Food Proteins for Potential Cross-reactivity.’’ 

Molecular Nutrition and Food Research, 

60(5):1183–1198, 2016. 

List of Subjects in 21 CFR Part 73 

Color additives, Cosmetics, Drugs, 

Foods, Medical devices. 

Therefore, 21 CFR part 73 is amended 

as follows: 

PART 73—LISTING OF COLOR 

ADDITIVES EXEMPT FROM 

CERTIFICATION 

■ 1. The authority citation for part 73 

continues to read as follows: 

Authority: 21 U.S.C. 321, 341, 342, 343, 

348, 351, 352, 355, 361, 362, 371, 379e. 

■ 2. Add § 73.69 to subpart A to read as 

follows: 

§ 73.69 Butterfly pea flower extract. 

(a) Identity. (1) The color additive 

butterfly pea flower extract is a dark 

blue liquid prepared by the aqueous 

extraction of dried butterfly pea flowers 

from Clitoria ternatea. The extract is 

further processed by ultrafiltration to 

remove residues of plant products, 

followed by concentration and 

pasteurization. Citric acid may be used 

to control the pH. The color additive 


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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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