[Federal Register Volume 87, Number 90 (Tuesday, May 10, 2022)]
[Rules and Regulations]
[Pages 27931-27936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10025]


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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.

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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:
    <bullet> 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

[[Page 27932]]

information, or other information that identifies you in the body of 
your objection, that information will be posted on https://www.regulations.gov.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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 Sec.  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 Sec.  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

[[Page 27933]]

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 brownish-orange 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-[beta], [beta]-carotene-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 Sec.  
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

[[Page 27934]]

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 Sec.  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 Sec.  70.25.
    Under Sec.  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 Sec.  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 Sec.  501.4 (21 CFR 501.4). The new regulation, Sec.  
73.32(d)(2) (21 CFR 73.32(d)(2)), references Sec.  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 Sec.  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, 
Sec.  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 Sec.  
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 Sec. Sec.  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 Sec.  
73.32(d)(3), references Sec. Sec.  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 Sec.  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 Sec.  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

[[Page 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. Miranda-Bermudez, 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

0
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.


0
2. Add Sec.  73.32 to read as follows:


Sec.  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 Sec.  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

[[Page 27936]]

premixes prepared therefrom must bear expiration dates for the sealed 
and open container (established through generally accepted stability 
testing methods), other information required by Sec.  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 Sec.  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 Sec. Sec.  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