Federal Register / Vol. 87, No. 90 / Tuesday, May 10, 2022 / Rules and Regulations 27931 

9The FAA anticipates that any outage would be 

of short duration and any potential risk would be 

minimal because, concurrent with the outage, GPS 

performance would have to fall below rule values 

on the route of flight and radar coverage would 

have to be unavailable at the same time and 

location. 

SAPT Outages 

As noted, certain operators are 

required to use a preflight availability 

prediction tool prior to a planned flight. 

Some operators will use the FAA SAPT 

for this purpose. The FAA intends that 

SAPT will be continuously available to 

operators. However, because 

unexpected circumstances could lead to 

a SAPT outage, the inability to access 

the tool could have an adverse impact 

on operators with SA-On receivers. As 

previously noted in Advisory Circular 

(AC) 90–114, ADS–B Operations, ATC 

will issue a NOTAM announcing when 

the SAPT is not available. 

The FAA understands that a SAPT 

outage prevents those operators who 

hold relief under Exemption No. 12555 

from confirming the availability of backup surveillance as required under the 

exemption’s conditions and 

limitations.9 It also reduces the ability 

of non-exemption holders without their 

own preflight availability prediction 

tool to determine that a particular 

operation will meet the performance 

requirements prior to conducting an 

operation. The unavailability of the 

SAPT for brief periods would result in 

operators having to choose between 

conducting flights that might result in 

non-compliance or not conducting an 

operation that might have complied 

with ADS–B Out rule performance. The 

FAA does not intend to inhibit 

operators from conducting otherwise 

permissible operations when the SAPT 

is unavailable. As such, when there is 

a SAPT outage, the policy described 

above will apply to operators who rely 

on the SAPT if their operation falls 

below the performance requirements. 

III. Summary 

Unless otherwise authorized by ATC, 

all aircraft operating in the airspace 

identified in § 91.225 must comply with 

the ADS–B Out performance 

requirements in § 91.227. Under the 

FAA’s revised policy, aircraft equipped 

with SA-Aware GPS receivers described 

in this document are not required to 

perform a preflight service availability 

prediction, including those aircraft not 

covered by Exemption 12555. Aircraft 

equipped with SA-On receivers should 

continue performing preflight 

availability predictions and can use the 

guidance contained in AC 90–114, 

ADS–B Operations, when conducting 

preflight actions for operations planned 

within airspace described in § 91.225. 

Holders of Exemption 12555 must 

continue to meet the conditions and 

limitations associated with the 

exemption. Holders of Exemption 12555 

should revise applicable equipage plans 

to reflect any changes affected by policy 

contained in this document and submit 

revised plans to the FAA per conditions 

specified by the exemption. 

As described in this document, there 

are circumstances outside of an 

operator’s control that may result in a 

temporary degradation of GPS 

performance and an apparent violation 

of § 91.227. An operator may exercise 

due diligence in performing a preflight 

availability prediction for its intended 

route of flight but experience rerouting 

by ATC after obtaining an initial ATC 

route clearance, which may cause an 

unanticipated degradation of 

performance. Additionally, an operator 

may encounter actual GPS interference 

on its intended path of flight, which 

would affect the ability of an aircraft to 

meet the performance requirements of 

§ 91.227. Lastly, an operator may not be 

able to complete a preflight availability 

prediction for its intended route of flight 

due to the FAA’s SAPT being out of 

service. As previously explained, the 

FAA recognizes that these situations are 

outside of the operator’s control. 

Therefore, the FAA will not take legal 

enforcement action for apparent 

noncompliance with § 91.227 due to the 

circumstances discussed in this 

document to the extent such an 

application would impose a standard of 

conduct wholly outside the operator’s 

control. 

IV. Effective Date 

Policy in this document is effective 

immediately and supersedes policy 

contained in FRN Docket No. FAA– 

2019–0539. Additional information on 

the policy described in this document 

will be contained in the next revision of 

AC 90–114, ADS–B Operations. 

Issued in Washington, DC, on May 4, 2022. 

Gregory E. Schwab, 

Acting Chief of Staff, Air Traffic Organization. 

[FR Doc. 2022–09936 Filed 5–9–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 73 

[Docket No. FDA–2018–C–1007] 

Listing of Color Additives Exempt 

From Certification; Antarctic Krill Meal 

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 

amending the color additive regulations 

to provide for the safe use of Antarctic 

krill meal, composed of the ground and 

dried tissue of Euphausia superba, with 

or without the lipid fraction, for use in 

the feed of salmonid fish, to enhance the 

color of their flesh. We are taking this 

action in response to a color additive 

petition (CAP) submitted by Aker 

BioMarine Antarctic AS (Aker 

BioMarine or petitioner). 

DATES: This rule is effective June 10, 

2022. Submit either electronic or 

written objections and requests for a 

hearing on the final rule by June 9, 

2022. See section XI for further 

information on the filing of objections. 

ADDRESSES: You may submit objections 

and requests for a hearing as follows. 

Please note that late, untimely filed 

objections will not be considered. The 

https://www.regulations.gov electronic 

filing system will accept comments 

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

of June 9, 2022. 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 


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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–1007 for ‘‘Listing of Color 

Additives Exempt From Certification; 

Antarctic Krill Meal.’’ 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, Office of Food 

Additive Safety (HFS–255), Center for 

Food Safety and Applied Nutrition, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740– 

3835, 240–402–2710; or Alexandra 

Jurewitz, Office of Regulations and 

Policy (HFS–024), Center for Food 

Safety and Applied Nutrition, Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2378. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

In a notification published in the 

Federal Register of April 9, 2018 (83 FR 

15089), we announced that we filed a 

color additive petition (CAP 5C0303) 

submitted by Aker BioMarine Antarctic 

AS (Aker BioMarine), c/o Intertek 

Scientific & Regulatory Consultancy, 

Rm. 1036, Bldg. A8 Cody Technology 

Park, Ively Rd., Farnborough, 

Hampshire, GU14 0LX, United 

Kingdom. 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 Antarctic krill 

meal, composed of the ground and dried 

tissue of Euphausia superba, with or 

without removal of the lipid fraction, for 

use in the feed of salmonid fish, to 

enhance the color of their flesh. Aker 

BioMarine proposed use levels not to 

exceed 4 percent (weight/weight or 

w/w) in feed for freshwater salmonids 

and 12 percent (w/w) in feed for marine 

salmonids. Antarctic krill meal is 

primarily intended for use as a nutrient 

source, partially replacing other meals 

(especially fish meal) used in the diet of 

salmonids. Antarctic krill meal is a 

natural source of astaxanthin, and it has 

been established that astaxanthin can 

impart color to the edible tissues of the 

salmonids. 

Antarctic krill meal is not intended to 

be the sole source of pigmentation in 

salmonid feed, and other permitted 

color additives—including other 

permitted sources of astaxanthin—may 

be added to achieve the desired level of 

coloration in the fish flesh. In the 

Federal Register of April 13, 1995 (60 

FR 18736), we published a final rule 

that listed astaxanthin in § 73.35 (21 

CFR 73.35) for use in the feed of 

salmonid fish. In that final rule, we 

concluded that 80 milligrams (mg) of 

astaxanthin per kilogram (kg) of finished 

feed may be safely used to enhance 

pigmentation of the flesh of salmonid 

fish, and we limited the astaxanthin 

content of the finished feed to not more 

than 80 mg/kg in § 73.35(c)(2). In the 

Federal Register of July 6, 2000 (65 FR 

41581 and 65 FR 41584), we published 

final rules that listed haematococcus 

algae meal in 21 CFR 73.185 and phaffia 

yeast in 21 CFR 73.355 as additional 

sources of astaxanthin permitted for use 

in the feed of salmonid fish, provided 

that the quantity of astaxanthin in 

finished feed from either color 

additive—when used alone or in 

combination with other astaxanthin 

color additive sources listed in part 73— 

results in no more than 80 mg/kg of 

astaxanthin in the finished feed. In the 

Federal Register of November 5, 2009 

(74 FR 57248), and November 16, 2009 

(74 FR 58845), we published final rules 

that listed astaxanthin 

dimethyldisuccinate (21 CFR 73.37) and 

paracoccus pigment (21 CFR 73.352), 

respectively, as color additive 

astaxanthin sources permitted in 

salmonid fish feed with the limitation 

that they impart no more than 80 mg/ 

kg of astaxanthin when used alone or in 

combination with other astaxanthin 

sources listed in part 73 as a condition 

of use. 

Consistent with these regulations, the 

petitioner proposed that the quantity of 

astaxanthin in the finished feed 

contributed by Antarctic krill meal 

when used under the intended 

conditions of use, alone or in 

combination with other permitted 

sources of astaxanthin, should not 

exceed 80 mg/kg astaxanthin in the 

finished feed. 

This final rule covers only the 

intended use of Antarctic krill meal as 

a color additive in the feed of salmonid 

fish, as the target animal. Under 21 CFR 

70.42, we apply a ‘‘safe-for-use’’ 

principle when evaluating a color 

additive petition. This approach ensures 

that each listed color additive will be 

safe for its intended use or uses in or on 

food, drugs, or cosmetics. In reviewing 

this color additive petition for the 

proposed intended use of Antarctic krill 


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meal in the feed of salmonid fish, we 

evaluated the safety of the petitioned 

use of the additive in the diet of both 

the target animal and humans. A 

discussion of this evaluation can be 

found in sections III and IV of this 

document. Approvals for other potential 

uses, such as in non-target animal food, 

were not the subject of this petition and 

therefore are not discussed below. 

However, such approvals may be subject 

to the provisions of section 409(b) or 

721(b) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

348(b) or 21 U.S.C. 379e(b)) and 21 CFR 

570.30 or 71.1. 

II. Background 

Antarctic krill meal is a brownishorange powder composed of the cooked, 

dried, and ground tissue of Euphausia 

superba. To obtain the color additive, 

Antarctic krill are harvested from 

Antarctic waters and processed by 

cooking, drying, and milling to yield 

whole Antarctic krill meal. The 

manufacture of defatted Antarctic krill 

meal includes an additional step of lipid 

extraction with ethanol. Residual 

ethanol in the krill biomass is removed 

by evaporation, yielding defatted 

Antarctic krill meal. The petition 

requests approval of the whole Antarctic 

krill meal and the defatted form of 

Antarctic krill meal for use as a color 

additive in salmonid feed. 

The primary coloring component in 

Antarctic krill meal is astaxanthin. 

Astaxanthin is an oxygenated 

carotenoid (xanthophyll) with the 

chemical name 3,3′-dihydroxy-b, bcarotene-4,4′-dione and may consist of 

cis, trans, and optical isomers. 

Astaxanthin is found as the mono- and 

di-astaxanthin esters and as free 

astaxanthin. Astaxanthin is present at 

levels of 80 to 170 mg/kg in the whole 

Antarctic krill meal and 10 to 90 mg/kg 

in the defatted Antarctic krill meal, 

calculated as free astaxanthin (Ref. 1). 

Ethoxyquin, an additive approved for 

use in animal feed, may be added as a 

stabilizer to whole Antarctic krill meal. 

Under § 573.380 (21 CFR 573.380), 

ethoxyquin may be safely used in fish 

feeds as a chemical preservative to 

retard the oxidation of xanthophylls at 

a level not to exceed 150 parts per 

million (150 ppm) in the treated article. 

The petition proposes the optional 

addition of ethoxyquin into whole 

Antarctic krill meal at levels up to 250 

mg/kg (250 ppm). When the whole krill 

meal is formulated with other fish feed 

ingredients up to a maximum level of 12 

percent by weight in feed for marine 

salmonids and 4 percent by weight in 

feed for freshwater salmonids to 

produce a finished feed, the 

concentration of ethoxyquin from the 

whole krill meal in the finished feed 

would be no more than 30 ppm and 10 

ppm, respectively. 

III. Safety Evaluation 

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

Act, 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. 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. 

Because consumers are not directly 

exposed to Antarctic krill meal, FDA 

focused its review on the safety of the 

substances present in Antarctic krill 

meal that are deposited in the 

consumable portions of the fish. We 

considered the safety of astaxanthin, 

which is already approved for use in the 

feed of salmonid fish, as well as the 

safety of other components found in 

Antarctic krill meal at levels higher than 

that in other fish meals, for which 

Antarctic krill meal is intended to serve 

as a replacement in salmonid feed. 

Target animal safety was also evaluated 

for the salmonids consuming the 

Antarctic krill meal. Our review was 

based on the petitioned use in salmonid 

feed and on human consumption of the 

consumable portions of these 

salmonids. 

IV. Safety of Petitioned Use of the Color 

Additive 

A. Exposure Estimate 

Astaxanthin is found in wild 

salmonids and is the principal pigment 

that imparts the pink or red coloring 

characteristic of the flesh of these fish. 

As referenced above, astaxanthin is 

currently approved for use as a color 

additive in the feed of salmonid fish at 

levels not to exceed 80 mg/kg of the 

finished feed. Antarctic krill meal is not 

intended to be the sole source of 

pigmentation in salmonid feed, and 

other permitted sources of astaxanthin 

may be added in order to achieve the 

desired level of coloration in the fish 

flesh. The quantity of astaxanthin in the 

finished feed contributed by Antarctic 

krill meal when used under the 

intended conditions of use, alone or in 

combination with other permitted 

sources of astaxanthin, is not to exceed 

80 mg/kg astaxanthin. Therefore, the 

exposure to astaxanthin from the 

petitioned use of Antarctic krill meal is 

substitutional for the currently 

approved uses of astaxanthin, and there 

would be no increase in human 

exposure to astaxanthin from this use 

(Ref. 2). 

Additionally, we considered the 

exposure to astaxanthin from the 

consumption of wild salmon and the 

exposure to astaxanthin from the 

consumption of farm-raised salmonid 

fish that have been fed approved color 

additive sources of these carotenoids to 

be comparable. We conclude that the 

petitioned use of Antarctic krill meal 

will not increase the exposure to 

astaxanthin (Ref. 3). 

The petition notes that Antarctic krill 

meal contains higher levels of fluoride 

than are present in the fish meal it is 

intended to partially replace. The 

petitioner indicated that salmonids that 

consume a relatively high dietary 

concentration of fluoride from the 

petitioned use of Antarctic krill meal 

may exhibit elevated levels of fluoride 

in the kidney and bones, but no 

significant accumulation in the edible 

tissues (muscle meat and skin) is 

anticipated. The petitioner indicated 

that canned salmon may contain bones 

from the fish that could be consumed by 

humans. Therefore, we considered 

fluoride exposure to humans from the 

consumption of canned salmon (Ref. 2). 

B. Toxicological Considerations 

To support the safety of the petitioned 

use of the subject color additive, 

including astaxanthin, the petitioner 

noted that synthetically produced and 

naturally derived astaxanthin has been 

previously approved for safe use as a 

color additive in salmonid feed. The 

petitioner noted that the astaxanthin in 

Antarctic krill meal occurs in the same 

optical isomer distribution as is found 

in wild salmon and in the naturally 

occurring astaxanthin coloring additives 

currently permitted for use in salmonid 

feed. In previous safety evaluations of 

other sources of astaxanthin, FDA 

concluded that the esterified forms of 

astaxanthin that are present in Antarctic 

krill meal present no additional safety 

concerns as compared to free 

astaxanthin because they are converted 

to the free form during digestion in the 

fish (Refs. 4 and 5). 

The petitioner noted that Antarctic 

krill meal contains a higher level of 


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fluoride than is typically present in the 

fish meal it is intended to partially 

replace. The petitioner indicated that 

salmonids that consume an increased 

dietary concentration of fluoride from 

the petitioned use of Antarctic krill 

meal may exhibit elevated levels of 

fluoride in the kidney and bones. 

However, no significant accumulation of 

fluoride in the edible tissues (muscle 

meat and skin) is anticipated. FDA 

considered a possible increase in human 

fluoride exposure due to the 

consumption of fish fed a diet 

containing Antarctic krill meal. We 

concluded that we have no safety 

concerns regarding the level of fluoride 

when humans are consuming the flesh 

of salmonids fed feed containing 

Antarctic krill meal or when humans are 

consuming canned salmon made from 

these fish (Ref. 4). 

Regarding the target animal safety of 

the Antarctic krill meal, the petitioner 

included data and literature references 

addressing nutrition, astaxanthin 

content, and fluoride content of 

Antarctic krill meal when fed to 

salmonids. These studies did not reveal 

any toxicity to the target fish species 

(Ref. 3). 

Based on the substitutional exposure 

to astaxanthin, the safety of astaxanthin 

to humans and the target fish species, 

and our consideration of the fluoride 

content of the additive, we conclude 

there is a reasonable certainty of no 

harm to humans or to the target fish 

species from the proposed use of 

Antarctic krill meal. 

V. Labeling Requirements 

In accordance with § 70.25 (21 CFR 

70.25), all color additives must be 

labeled with sufficient information to 

assure their safe use and to allow a 

determination of compliance with any 

limitations imposed by FDA in other 

applicable regulations. Therefore, the 

labeling of the color additive, Antarctic 

krill meal, and any mixture prepared 

therefrom, is subject to the requirements 

of § 70.25. 

Under § 70.25(a)(4), an expiration date 

for a color additive must be stated on its 

label if stability data require it. The 

petitioner determined the stability of 

astaxanthin as a color additive in the 

product to be approximately 12 months. 

Although the effect of imparting color 

may be attenuated after 12 months, the 

degradation of the astaxanthin-based 

coloring components does not form any 

new substances of toxicological 

concern. FDA finds that because of the 

potential impact on the stability of 

astaxanthin in Antarctic krill meal after 

12 months, an expiration date must be 

stated on the label of sealed and open 

containers, in accordance with 

§ 70.25(a)(4). 

In addition to the requirements for 

labeling the color additive or color 

additive mixture, the ingredient list on 

fish feed, to which Antarctic krill meal 

is added, must identify the presence of 

the color additive under § 501.4 (21 CFR 

501.4). The new regulation, § 73.32(d)(2) 

(21 CFR 73.32(d)(2)), references § 501.4 

to ensure that the presence of Antarctic 

krill meal as a color additive in the fish 

feed will be declared on the ingredient 

label. 

The presence of the color additive 

must be declared on the label of any 

food. This is to include a declaration on 

the label of salmonid fish fed feed 

containing added Antarctic krill meal 

and on the label of food containing such 

salmonid fish as an ingredient. Our 

regulations, at § 101.22(b) (21 CFR 

101.22(b)), require a food that bears or 

contains artificial coloring, such as 

salmon artificially colored with 

Antarctic krill meal, to bear labeling 

even though such food is not in package 

form. Section 101.22(c) requires that 

label statements of artificial coloring be 

likely to be read by the ordinary person 

under customary conditions of purchase 

and use of such food. Furthermore, 

§ 101.22(k)(2) requires, in the statement 

of ingredients for a food to which any 

coloring has been added, and for which 

the coloring is not subject to 

certification, a declaration that makes it 

clear that a color additive has been used 

in the food. In addition, the presence of 

a color additive in a food received in a 

bulk container that is held at a retail 

establishment must be declared on the 

labeling of the bulk container or on a 

counter card or other similar device 

under § 101.100(a)(2) (21 CFR 

101.100(a)(2)). The ingredient label 

would alert the consumer that the fish 

is artificially colored. Without such 

ingredient labeling, food comprising 

salmonid fish fed feed with added 

Antarctic krill meal would be deemed to 

be misbranded under section 403(k) of 

the FD&C Act (21 U.S.C. 343(k)), which 

states that a food shall be deemed to be 

misbranded if it bears or contains any 

artificial flavoring, artificial coloring, or 

chemical preservative, unless it bears 

labeling stating that fact. 

Therefore, in accordance with 

§§ 101.22(b), (c), and (k)(2) and 

101.100(a)(2), labeling on any salmonid 

fish fed feed with added Antarctic krill 

meal is required to declare the presence 

of the color additive or color additive 

mixture. The new regulation, at 

§ 73.32(d)(3), references §§ 101.22(b), 

(c), and (k)(2) and 101.100(a)(2) to 

ensure that, at the retail level, the 

presence of Antarctic krill meal as a 

color additive in the fish will be 

declared, and that the labeling of the 

bulk fish container, including a list of 

ingredients, will be displayed on the 

container or on a counter card with 

similar information. 

VI. Conclusion 

Based on the data and information in 

the petition and other available relevant 

information, we conclude that the 

petitioned use of Antarctic krill meal, 

for use as a color additive is safe to the 

target fish species and to humans who 

consume this fish, at levels not to 

exceed 4 percent (w/w) in feed for 

freshwater salmonids and 12 percent 

(w/w) in feed for marine salmonids. 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 Antarctic krill meal is 

not necessary to protect the public 

health. 

VII. 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. 

VIII. Analysis of Environmental Impact 

We have carefully considered the 

potential environmental effects of this 

action. FDA has concluded that the 

action will not have a significant impact 

on the human environment and that an 

environmental impact statement is not 

required (Ref. 6). FDA’s finding of no 

significant impact and the evidence 

supporting that finding, contained in an 

environmental assessment, may be seen 

in the Dockets Management Staff (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday. 

IX. 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. 

X. 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 


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Federal Register / Vol. 87, No. 90 / Tuesday, May 10, 2022 / Rules and Regulations 27935 

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. 

XI. 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. 

XII. References 

The following references 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 are also available 

electronically at https://

www.regulations.gov. 

1. Memorandum from E. MirandaBermudez, Color Technology Branch, 

Division of Color Certification and 

Technology (DCCT), Office of Cosmetics and 

Colors (OCAC), 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, March 14, 2020. 

2. Memorandum from D. Doell, Chemistry 

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

DiFranco, DFI, OFAS, CFSAN, FDA, March 

11, 2020. 

3. Memorandum from L. Post, Target 

Animal Review, Division of Animal Feeds, 

Office of Surveillance and Compliance, 

Center for Veterinary Medicine, FDA to S. 

DiFranco, DFI, OFAS, CFSAN, FDA, July 30, 

2019. 

4. Memorandum from T. Thurmond, 

Toxicology Review Team, DFI, OFAS, 

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

CFSAN, FDA, March 14, 2020. 

5. Memorandum from T. Thurmond, 

Toxicology Review Team, Division of 

Petition Review (DPR), OFAS, CFSAN, FDA 

to F. Ellison, DPR, OFAS, CFSAN, FDA, 

February 3, 2009. 

6. Memorandum from M. Pfeil, 

Environmental Review Team, Division of 

Science and Technology, OFAS, CFSAN, 

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

FDA, March 23, 2020. 

List of Subjects in 21 CFR Part 73 

Color additives, Cosmetics, Drugs, 

Foods, Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under the 

authority delegated to the Commissioner 

of the Food and Drugs, 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 § 73.32 to read as follows: 

§ 73.32 Antarctic krill meal. 

(a) Identity. (1) The color additive 

Antarctic krill meal consists of the 

cooked, dried, and ground biomass of 

whole Euphausia superba (Antarctic 

krill), with or without removal of the 

lipid fraction. The lipid fraction may be 

fully or partially extracted with ethanol, 

followed by removal of residual ethanol, 

to produce defatted Antarctic krill meal. 

Whole Antarctic krill meal, produced 

when the lipid fraction is not removed, 

may contain ethoxyquin as a 

preservative. 

(2) Color additive mixtures for fish 

feed use made with Antarctic krill meal 

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. Antarctic krill meal 

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) Physical state, solid. 

(2) Ethoxyquin, not more than 250 

milligrams per kilogram (mg/kg) (250 

parts per million (ppm)) in whole 

Antarctic krill meal. 

(3) Lead, not more than 2 mg/kg (2 

ppm). 

(4) Arsenic, not more than 5 mg/kg (5 

ppm). 

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

ppm). 

(6) Cadmium, not more than 2 mg/kg 

(2 ppm). 

(7) Fluoride, not more than 2,500 mg/ 

kg (2,500 ppm). 

(8) Astaxanthin, not more than 170 

mg/kg (170 ppm) in whole Antarctic 

krill meal; not more than 90 mg/kg (90 

ppm) in defatted Antarctic krill meal. 

(c) Uses and restrictions. Antarctic 

krill meal may be safely used in 

salmonid feed in accordance with the 

following prescribed conditions: 

(1) The color additive is used to 

enhance the pink to orange-red color of 

the flesh of salmonid fish; 

(2) The color additive may be used at 

levels not to exceed 4 percent by weight 

in freshwater salmonid feed and 12 

percent by weight in marine salmonid 

feed; 

(3) The quantity of the color additive 

incorporated in the feed is such that the 

finished feed meets the tolerance 

limitation for ethoxyquin in animal feed 

prescribed in § 573.380 of this chapter; 

and 

(4) The quantity of astaxanthin in the 

finished feed, from Antarctic krill meal 

when used alone or in combination with 

other astaxanthin color additive sources 

listed in this part, must not exceed 80 

mg/kg astaxanthin (72 grams per ton) in 

the finished feed. 

(d) Labeling requirements. (1) The 

labeling of the color additive and any 


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premixes prepared therefrom must bear 

expiration dates for the sealed and open 

container (established through generally 

accepted stability testing methods), 

other information required by § 70.25 of 

this chapter, a statement of the 

concentration of ethoxyquin contained 

therein (whole Antarctic krill meal 

only), and adequate directions to 

prepare a final product complying with 

the limitations prescribed in paragraph 

(c) of this section. 

(2) The presence of the color additive 

in finished fish feed prepared according 

to paragraph (c) of this section must be 

declared in accordance with § 501.4 of 

this chapter. 

(3) The presence of the color additive 

in salmonid fish that have been fed 

feeds containing Antarctic krill meal 

must be declared in accordance with 

§§ 101.22(b), (c), and (k)(2) and 

101.100(a)(2) 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 

thereof are exempt from the certification 

requirements of section 721(c) of the 

Federal Food, Drug, and Cosmetic Act. 

Dated: May 5, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10025 Filed 5–9–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF JUSTICE 

Office of the Attorney General 

28 CFR Part 50 

[Docket No. OAG 177; AG Order No. 5384– 

2022] 

RIN 1105–AB62 

Guidelines and Limitations for 

Settlement Agreements Involving 

Payments to Non-Governmental Third 

Parties 

AGENCY: Department of Justice. 

ACTION: Interim final rule; request for 

comments. 

SUMMARY: This interim final rule 

(‘‘rule’’) revokes regulations of the 

Department of Justice (‘‘Department’’) 

that codified a prohibition, subject to 

limited exceptions, on the inclusion of 

provisions in settlement agreements 

directing or providing for a payment or 

loan, in cash or in kind, to any nongovernmental person or entity that is 

not a party to the dispute. For further 

information on how the Department 

intends to approach such settlements 

going forward, interested parties should 

consult an Attorney General 

Memorandum that the Department is 

issuing on its website in conjunction 

with this rule. Comments are requested 

both as to this rule and as to that 

Memorandum. 

DATES: 

Effective date: This rule is effective 

May 10, 2022. 

Applicability date: May 5, 2022. 

Comments: Comments are due on or 

before July 11, 2022. 

ADDRESSES: To ensure proper handling 

of comments, please reference Docket 

No. OAG 177 on all electronic and 

written correspondence. The 

Department encourages the electronic 

submission of all comments through 

https://www.regulations.gov using the 

electronic comment form provided on 

that site. For ease of reference, an 

electronic copy of this document is also 

available at that website. It is not 

necessary to submit paper comments 

that duplicate the electronic 

submission, as comments submitted to 

https://www.regulations.gov will be 

posted for public review and are part of 

the official docket record. However, 

should you wish to submit written 

comments through regular or express 

mail, they should be sent to Robert 

Hinchman, Senior Counsel, Office of 

Legal Policy, U.S. Department of Justice, 

Room 4252 RFK Building, 950 

Pennsylvania Avenue NW, Washington, 

DC 20530. Comments received by mail 

will be considered timely if they are 

postmarked on or before July 11, 2022. 

The electronic Federal eRulemaking 

portal will accept comments until 

Midnight Eastern Time at the end of that 

day. 

FOR FURTHER INFORMATION CONTACT: 

Robert Hinchman, Senior Counsel, 

Office of Legal Policy, U.S. Department 

of Justice, telephone (202) 514–8059 

(not a toll-free number). 

SUPPLEMENTARY INFORMATION: 

I. Posting of Public Comments 

Please note that all comments 

received are considered part of the 

public record and made available for 

public inspection online at https://

www.regulations.gov. Information made 

available for public inspection includes 

personal identifying information (such 

as your name, address, etc.) voluntarily 

submitted by the commenter. 

You are not required to submit 

personal identifying information in 

order to comment on this rule. 

Nevertheless, if you want to submit 

personal identifying information (such 

as your name, address, etc.) as part of 

your comment, but do not want it to be 

posted online, you must include the 

phrase ‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You must also locate 

all the personal identifying information 

that you do not want posted online in 

the first paragraph of your comment and 

identify what information you want the 

agency to redact. Personal identifying 

information identified and located as set 

forth above will be placed in the 

agency’s public docket file, but not 

posted online. 

If you want to submit confidential 

business information as part of your 

comment but do not want it to be posted 

online, you must include the phrase 

‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify the confidential 

business information to be redacted 

within the comment. If a comment has 

so much confidential business 

information that it cannot be effectively 

redacted, the agency may choose not to 

post that comment (or to post that 

comment only partially) on https://

www.regulations.gov. Confidential 

business information identified and 

located as set forth above will not be 

placed in the public docket file, nor will 

it be posted online. 

If you want to inspect the agency’s 

public docket file in person by 

appointment, please see the FOR

FURTHER INFORMATION CONTACT section. 

II. Discussion 

A. Overview 

This rule revokes the Department’s 

regulations at 28 CFR 50.28. Going 

forward, the Department’s approach to 

settlement agreements that direct or 

provide for a payment or a loan, in cash 

or in kind, to a non-governmental 

person or entity that is not a party to the 

dispute will be governed by a new 

Attorney General Memorandum being 

issued on the Department’s website 

concurrently with this rule. 

B. Background 

For decades prior to 2017, Department 

components had entered into settlement 

agreements that involved payments to 

certain third parties as a means of 

addressing harms arising from 

violations of Federal law, particularly in 

the environmental context but in other 

contexts as well. In 2017, the Attorney 

General issued a memorandum 

prohibiting Department attorneys from 

‘‘enter[ing] into any agreement on behalf 

of the United States in settlement of 

federal claims or charges, including 

agreements settling civil litigation, 

accepting plea agreements, or deferring 

or declining prosecution in a criminal 


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