[Federal Register Volume 87, Number 90 (Tuesday, May 10, 2022)]
[Rules and Regulations]
[Pages 27931-27936]
[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:
     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-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,<PHONE_NUMBER>.
     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,<PHONE_NUMBER>.

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,<PHONE_NUMBER>; 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,<PHONE_NUMBER>.

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

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

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

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

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


[Federal Register Volume 80, Number 82 (Wednesday, April 29, 2015)]
[Notices]
[Page 23795]
[FR Doc No: 2015-09887]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0086; FRL-9925-72]

Full SFIREG; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Association of American Pesticide Control Officials
(AAPCO)/State, Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), Issues Research and Evaluation Group (SFIREG), Full Committee
will hold a 2-day meeting, beginning on June 1, 2015, and ending June
2, 2015. This notice announces the location and times for the meeting
and sets forth the tentative agenda topics.

DATES: The meeting will be held on Monday, June 1, 2015, from 8:00 a.m.
to 5:00 p.m. and 8:30 a.m. to noon on Tuesday, June 2, 2015.
    To request accommodation of a disability, please contact the person
listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10
days prior to the meeting, to give EPA as much time as possible to
process your request.

ADDRESSES: The meeting will be held at EPA. One Potomac Yard (South
Bldg.) 2777 Crystal Dr., Arlington, VA., First Floor, South Conference
Room.

FOR FURTHER INFORMATION CONTACT: Ron Kendall, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>or Amy Bamber, SFIREG Executive
Secretary, at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are
interested in pesticide regulation issues affecting states and any
discussion between EPA and SFIREG on FIFRA field implementation issues
related to human health, environmental exposure to pesticides, and
insight into EPA's decision-making process. You are invited and
encouraged to attend the meetings and participate as appropriate.
Potentially affected entities may include, but are not limited to
persons who are or may be required to conduct testing of chemical
substances under the Federal Food, Drug and Cosmetics Act (FFDCA), or
FIFRA and those who sell, distribute or use pesticides, as well as any
nongovernment organization. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2015-0086, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave., NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

II. Tentative Agenda Topics

1. OPP/OECA Program Updates
2. Update on SmartLabel and the E-Enterprise project
3. Design for the Environment (DfE) logos on pesticide labels
4. SFIREG Guidance on State Managed Pollinator Plans
5. Report on first OPP/OECA Project Officer Training Session
6. Federal Credentials update on any revisions to the state/tribal
guidance to clarify regional flexibility in determining inspector
experience
7. Discuss adjustments to inspection time allocations (Results of SLA
survey)
8. EPA Spanish Labeling Workgroup
9. Discussion on Office of Inspector General (OIG) Quick Action Report
on Region 8
10. Review of FY 2016-17 NPM Guidance

III. How can I request to participate in this meeting?

    This meeting is open for the public to attend. You may attend the
meeting without further notification.

    Authority:  7 U.S.C. 136 et seq.

    Dated: April 14, 2015.
Jacqueline E. Mosby,
Director, Field and External Affairs Division, Office of Pesticide
Programs.
[FR Doc. 2015-09887 Filed 4-28-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 220 (Friday, November 14, 2014)]
[Notices]
[Pages 68275-68277]
[FR Doc No: 2014-26998]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0878]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Premarket Notification for a New Dietary Ingredient

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the procedure by which a
manufacturer or distributor of a new dietary ingredient or of a dietary
supplement containing a new dietary ingredient is to submit to FDA
information upon which it has based its conclusion that a dietary
supplement containing the new dietary ingredient will reasonably be
expected to be safe. The notice also invites comments on two new forms
FDA is developing to allow manufacturers and distributors to submit
this information electronically via FDA's Unified Registration and
Listing System (FURLS).

DATES: Submit either electronic or written comments on the collection
of information by January 13, 2015.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the

docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Premarket Notification for a New Dietary Ingredient--21 CFR 190.6 (OMB
Control Number 0910-0330)--Extension

    Section 413(a) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 350b(a)) provides that at least 75 days before the
introduction or delivery for introduction into interstate commerce of a
dietary supplement that contains a new dietary ingredient, the
manufacturer or distributor of the dietary supplement or of the new
dietary ingredient is to submit to FDA (as delegate for the Secretary
of Health and Human Services) information upon which the manufacturer
or distributor has based its conclusion that a dietary supplement
containing the new dietary ingredient will reasonably be expected to be
safe. FDA's implementing regulation, 21 CFR 190.6, requires this
information to be submitted to the Office of Nutrition, Labeling, and
Dietary Supplements (ONLDS) in the form of a notification. Under Sec.
190.6(b), the notification must include the following: (1) The name and
complete address of the manufacturer or distributor, (2) the name of
the new dietary ingredient, (3) a description of the dietary
supplement(s) that contain the new dietary ingredient, including the
level of the new dietary ingredient in the dietary supplement and the
dietary supplement's conditions of use, (4) the history of use or other
evidence of safety establishing that the new dietary ingredient will
reasonably be expected to be safe when used under the conditions
recommended or suggested in the labeling of the dietary supplement, and
(5) the signature of a responsible person designated by the
manufacturer or distributor.
    These premarket notification requirements are designed to enable us
to monitor the introduction into the marketplace of new dietary
ingredients and dietary supplements that contain new dietary
ingredients in order to protect consumers from ingredients and products
whose safety is unknown. FDA is the information collected in new
dietary ingredient notifications to evaluate the safety of new dietary
ingredients in dietary supplements and to support regulatory action
against ingredients and products that are potentially unsafe.
    FDA is developing an electronic portal that interested persons will
be able to use to electronically submit their notifications to ONLDS
via FURLS. Firms that prefer to submit a paper notification in a format
of their own choosing will still have the option to do so; however,
Form FDA 3880 prompts a submitter to input the elements of a new
dietary ingredient notification (NDIN) in a standard format and helps
the submitter organize its NDIN to focus on the information needed for
FDA's safety review. Safety information will be submitted via a
supplemental form entitled ``New Dietary Ingredient Safety
Information.'' This form provides a standard format to describe the
history of use or other evidence of safety on which the manufacturer or
distributor bases its conclusion that the new dietary ingredient will
be reasonably expected to be safe under the conditions of use
recommended or suggested in the labeling of the dietary supplement, as
well as related identity information that is necessary to demonstrate
safety by showing that the new dietary ingredient and dietary
supplement(s) that are the subject of the notification are the same or
similar to the ingredients and products for which safety data and
information have been provided. Draft screenshots of Form FDA 3880 and
the supplemental safety information form are available for comment at
http://www.fda.gov/Food/DietarySupplements/NewDietaryIngredientsNotificationProcess/ucm356620.htm.
    Description of Respondents: The respondents to this collection of
information are manufacturers and distributors in the dietary
supplement industry; specifically, firms that manufacture or distribute
new dietary ingredients or dietary supplements that contain a new
dietary ingredient.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                           21 CFR section                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
190.6..............................................................              55                1               55               20            1,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA believes that the burden of the premarket notification
requirement on industry is limited and reasonable because FDA is
requesting only safety and identity information that the manufacturer
or distributor should already have developed to satisfy itself that a
dietary supplement containing a new dietary ingredient is in compliance

with the FD&C Act. In the past, commenters have argued that FDA's
burden estimate is too low. FDA carefully considered the issue and
believes that burden estimates of greater than 20 hours are likely to
include the burden associated with researching and generating safety
data for a new dietary ingredient. Under section 413(a)(2) of the FD&C
Act, a dietary supplement that contains a new dietary ingredient is
deemed to be adulterated unless there is a history of use or other
evidence of safety establishing that the new dietary ingredient will
reasonably be expected to be safe under the conditions of use
recommended or suggested in the labeling of the dietary supplement.
This requirement is separate from and additional to the requirement to
submit a premarket notification for the new dietary ingredient. FDA's
regulation on new dietary ingredient notifications, Sec.  190.6(a),
requires the manufacturer or distributor of the dietary supplement or
of the new dietary ingredient to submit to FDA the information that
forms the basis for its conclusion that a dietary supplement containing
the new dietary ingredient will reasonably be expected to be safe.
Thus, Sec.  190.6 only requires the manufacturer or distributor to
extract and summarize information that should have already been
developed to meet the safety requirement in section 413(a)(2) of the
FD&C Act. FDA estimates that extracting and summarizing the relevant
information from what exists in the company's files and presenting it
in a format that meets the requirements of Sec.  190.6 will take
approximately 20 hours of work per notification. However, FDA seeks
comments on this estimate. FDA encourages comments offering alternative
burden estimates to include documentation to support the alternative
estimate.
    FDA further estimates that 55 respondents will submit 1 premarket
notification each. FDA bases its estimate of the number of respondents
on notifications received over the past 3 years, which averaged about
55 notifications per year.

    Dated: November 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26998 Filed 11-13-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 67 (Monday, April 10, 2017)]
[Rules and Regulations]
[Pages 17101-17103]
[FR Doc No: 2017-07060]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2016-9402; Special Conditions No. 25-655-SC]

Special Conditions: Embraer S.A. Model ERJ 190-300 Airplane;
Flight Envelope Protection, General Limiting Requirements

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

-----------------------------------------------------------------------

SUMMARY: These special conditions are issued for the Embraer S.A.
(Embraer) Model ERJ 190-300 airplane. This airplane will have a novel
or unusual design feature when compared to the state of technology
envisioned in the airworthiness standards for transport-category
airplanes. This design feature is a new control architecture and a full
digital flight-control system, both of which provide flight-envelope
protections. The applicable airworthiness regulations do not contain
adequate or appropriate safety standards for this design feature. These
special conditions contain the additional safety standards that the
Administrator considers necessary to establish a level of safety
equivalent to that established by the existing airworthiness standards.

DATES: This action is effective on Embraer on April 10, 2017. We must
receive your comments by May 25, 2017.

ADDRESSES: Send comments identified by docket number FAA-2016-9402
using any of the following methods:
     Federal eRegulations Portal: Go to http://www.regulations.gov/and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov/, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the

individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov/.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov/ at any time. Follow the online instructions
for accessing the docket or go to Docket Operations in Room W12-140 of
the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Joe Jacobsen, FAA, Airplane and
Flightcrew Interface, ANM-111, Transport Airplane Directorate, Aircraft
Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-
3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The substance of these special conditions
has been subject to the notice and comment period in several prior
instances and has been derived without substantive change from those
previously issued. It is unlikely that prior public comment would
result in a significant change from the substance contained herein.
Therefore, the FAA has determined that prior public notice and comment
are unnecessary and impracticable, and good cause exists for adopting
these special conditions upon publication in the Federal Register.

Comments Invited

    We invite interested people to take part in this rulemaking by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    We will consider all comments we receive by the closing date for
comments. We may change these special conditions based on the comments
we receive.

Background

    On September 13, 2013, Embraer applied for an amendment to Type
Certificate No. A57NM to include the new Model ERJ 190-300 airplane.
The Model ERJ 190-300 airplane, which is a derivative of the Embraer
Model ERJ 190-100 STD airplane currently approved under Type
Certificate No. A57NM, is a 97- to 114-passenger transport-category
airplane, designed with a new wing with a high aspect ratio and raked
wingtip, and a new electrical-distribution system. The maximum take-off
weight is 124,340 lbs (56,400 kg).

Type Certification Basis

    Under the provisions of Title 14, Code of Federal Regulations (14
CFR) 21.101, Embraer must show that the Model ERJ 190-300 airplane
meets the applicable provisions of the regulations listed in Type
Certificate No. A57NM, or the applicable regulations in effect on the
date of application for the change, except for earlier amendments as
agreed upon by the FAA.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Model ERJ 190-300 airplane because
of a novel or unusual design feature, special conditions are prescribed
under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same novel or
unusual design feature, or should any other model already included on
the same type certificate be modified to incorporate the same novel or
unusual design feature, these special conditions would also apply to
the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the Embraer Model ERJ 190-300 airplane must comply with the
fuel-vent and exhaust-emission requirements of 14 CFR part 34 and the
noise-certification requirements of 14 CFR part 36.
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type
certification basis under Sec.  21.101.

Novel or Unusual Design Features

    The Embraer Model ERJ 190-300 airplane will incorporate the
following novel or unusual design feature: A new control architecture
and a full digital flight-control system, both of which provide flight-
envelope protections.

Discussion

    The applicable airworthiness regulation that applies to these
special conditions is 14 CFR 25.143. The purpose of Sec.  25.143 is to
verify that any airplane operational maneuvers conducted within the
airplane operational envelope can be accomplished smoothly with average
piloting skill, and without exceeding any structural limits. The pilot
should be able to predict the airplane response to any control input.
During the course of the flight-test program, the pilot determines
compliance with Sec.  25.143 primarily through qualitative methods.
During flight test, the pilot evaluates all of the following:
     The interface between each protection function,
     Transitions from one mode to another,
     The aircraft response to intentional dynamic maneuvering,
whenever applicable, through dedicated maneuvers,
     General controllability,
     High speed characteristics, and
     High angle-of-attack.
    However, Sec.  25.143 does not adequately ensure that the novel or
unusual feature of the Embraer Model ERJ 190-300 airplane will have a
level of safety equivalent to that of existing standards. These special
conditions are required to accommodate the flight-envelope-limiting
systems in the Model ERJ 190-300 airplane.
    These special conditions contain the additional safety standards
that the Administrator considers necessary to establish a level of
safety equivalent to that established by the existing airworthiness
standards.

Applicability

    As discussed above, these special conditions are applicable to the
Embraer Model ERJ 190-300 airplane. Should Embraer apply at a later
date for a change to the type certificate to include another model
incorporating the same novel or unusual design feature, these special
conditions would apply to that model as well.
    This action affects only a certain novel or unusual design feature
on one model of airplane. It is not a rule of general applicability.
    The substance of these special conditions has been subject to the
notice and comment period in several prior instances and has been
derived without substantive change from those previously issued. It is
unlikely that prior public comment would result in a significant change
from the substance contained herein. Therefore, the FAA has determined
that prior public notice and comment are unnecessary and impracticable,
and good cause exists for adopting these special conditions upon
publication in the Federal Register. The FAA is requesting comments to
allow interested persons to submit views that may not have been
submitted in

response to the prior opportunities for comment described above.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Embraer Model ERJ 190-300 airplanes.

1. General Limiting Requirements

    a. Onset characteristics of each envelope protection feature must
be smooth, appropriate to the phase of flight and type of maneuver, and
not in conflict with the ability of the pilot to satisfactorily change
airplane flight path, speed, or attitude as needed.
    b. Limit values of protected flight parameters (and if applicable,
associated warning thresholds) must be compatible with the following:
    i. Airplane structural limits,
    ii. Required safe and controllable maneuvering of the airplane, and
    iii. Margins to critical conditions. Unsafe flight characteristics/
conditions must not result if dynamic maneuvering, airframe and system
tolerances (both manufacturing and in-service), and non-steady
atmospheric conditions, in any appropriate combination and phase of
flight, can produce a limited flight parameter beyond the nominal
design-limit value.
    c. The airplane must be responsive to intentional dynamic
maneuvering to within a suitable range of the parameter limit. Dynamic
characteristics such as damping and overshoot must also be appropriate
for the flight maneuver and limit parameter in question.
    d. When simultaneous envelope limiting is engaged, adverse coupling
or adverse priority must not result.

2. Failure States

    a. Electronic flight-control-system failures (including sensors)
must not result in a condition where a parameter is limited to such a
reduced value that safe and controllable maneuvering is no longer
available.
    b. The crew must be alerted by suitable means if any change in
envelope limiting or maneuverability is produced by single or multiple
failures of the electronic flight-control system not shown to be
extremely improbable.

    Issued in Renton, Washington, on March 15, 2017.
Dionne Palermo,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-07060 Filed 4-7-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 127 (Wednesday, July 5, 2017)]
[Rules and Regulations]
[Pages 30968-30969]
[FR Doc No: 2017-14047]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2017-0510]

Drawbridge Operation Regulation; Sacramento River, Rio Vista, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation; modification.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard has modified a temporary deviation from the
operating schedule that governs the Rio Vista Drawbridge across
Sacramento River, mile 12.8, at Rio Vista, CA. The modified deviation
extends the period the bridge may open with one hour advance notice and
is necessary to allow the bridge owner to make necessary emergency
repairs to the bridge.

DATES: This modified deviation is effective without actual notice from
July 5, 2017 through 4 a.m. on July 15, 2017. For the purposes of
enforcement actual notice will be used from June 28, 2017 until July 5,
2017.

ADDRESSES: The docket for this deviation, [USCG-2017-0510], is
available at http://www.regulations.gov. Type the docket number in the
``SEARCH'' box and click ``SEARCH.'' Click on Open Docket Folder on the
line associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Carl T. Hausner, Chief, Bridge
Section, Eleventh Coast Guard District; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On June 15, 2017, the Coast Guard published
a temporary deviation entitled ``Drawbridge Operation Regulation;
Sacramento River, Rio Vista, California'' in the Federal Register (82
FR 27423). That temporary deviation, from 7 p.m. on June 16, 2017 to 4
a.m. on July 1, 2017, allows the drawspan to open on one hour advance
notice at three specified time periods. The bridge owner, California
Department of Transportation, has requested a modification of the
currently published deviation to extend from 4 a.m. on July 1, 2017 to
4 a.m. on July 15, 2017 in order to complete the necessary repairs to
the bridge deck.
    The Rio Vista Drawbridge, mile 12.8, across the Sacramento River,
has a vertical clearance of 18 feet above Mean High Water in the
closed-to-navigation position. In accordance with 33 CFR 117.5, the
draw opens on signal. Navigation on the waterway is commercial, search
and rescue, law enforcement, and recreational.
    The drawspan will require a one hour advance notice at one
specified period: From 6 p.m. on July 14, 2017 to 4 a.m. on July 15,
2017. A one hour advance notice will give enough time for the
contractor to clear away equipment and workers before the drawspan can
safely open for transiting vessels. Scaffolding will be installed below
the bridge deck from July 1, 2017 through July 15, 2017, reducing the
vertical clearance by 4 feet, and will extend from the west tower 48
feet into the navigational channel. This temporary deviation
modification has been coordinated with the waterway users. No
objections to the proposed temporary deviation modification were
raised.

    Vessels able to pass through the bridge in the closed position may
do so at anytime. The bridge will be able to open for emergencies with
one hour advance notice. There is no immediate alternate route for
vessels to pass. The Coast Guard will also inform the users of the
waterway through our Local and Broadcast Notices to Mariners of the
change in operating schedule for the bridge so vessel operators can
arrange their transits to minimize any impact caused by the temporary
deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: June 28, 2017.
C.T. Hausner,
District Bridge Chief, Eleventh Coast Guard District.
[FR Doc. 2017-14047 Filed 7-3-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: June 26, 2006 (Volume 71, Number 122)]
[Notices]
[Page 36380-36382]
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54012; File No. SR-NYSE-2006-05]

Self-Regulatory Organizations; New York Stock Exchange, Inc. (n/
k/a New York Stock Exchange LLC); Order Approving Proposed Rule Change
as Amended by Amendments No. 1 and 2 Amending an Interpretation of NYSE
Rule 345 (Employees--Registration, Approval, Records)

June 16, 2006.

I. Introduction

    On February 17, 2006, the New York Stock Exchange, Inc. (n/k/a New
York Stock Exchange LLC) (``NYSE'' or ``Exchange'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposal to amend the filing
requirements in connection with the establishment of an ``independent
contractor'' relationship between a natural person, who is required to
be registered pursuant to NYSE Rule 345, and a member organization. On
May 3, 2006, NYSE filed Amendment No. 1 to the proposed rule change.
The proposed rule change, as amended, was published for comment in the
Federal Register on

May 17, 2006.\3\ On June 14, 2006, NYSE filed Amendment No. 2 to the
proposed rule change.\4\ The Commission received no comments regarding
the proposal. This order approves the proposed rule change, as amended.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 53789 (May 11,
2006), 71 FR 28735.
    \4\ In Amendment No. 2, the Exchange makes minor, non-
substantive changes to the rule text contained in Exhibit 5 of the
proposed rule change. This is a technical amendment and is not
subject to notice and comment.
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II. Description of the Proposal

    The NYSE proposes to amend Interpretation (a)/02 (``Independent
Contractors'') of NYSE Rule 345 (``Employees--Registration, Approval,
Records''). NYSE Rule 345(a) requires that natural persons performing
certain prescribed duties on behalf of a member organization be
registered with and qualified by the Exchange.\5\ The Interpretation of
NYSE Rule 345(a) \6\ permits a registered representative to assert the
status of ``independent contractor'' provided that any registered
representative associated with a member organization who is so
designated be considered an employee of that member organization for
purposes of the rules of the Exchange.
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    \5\ NYSE Rule 345(a) states that ``[n]o * * * member
organization shall permit any natural person to perform regularly
the duties customarily performed by (i) A registered representative,
(ii) a securities lending representative, (iii) a securities trader
or (iv) a direct supervisor of (i), (ii) or (iii) above, unless such
person shall have been registered with, qualified by and is
acceptable to the Exchange.''
    \6\ See NYSE Interpretation Handbook, Rule 345(a)/02.
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    Currently, the Interpretation subjects all independent contractor
arrangements to prior Exchange approval pursuant to the following four
conditions: (1) The member organization must provide written assurances
to the Exchange that it will supervise and control all activities of
the independent contractor effected on its behalf to the same degree
and extent that it supervises and controls the activities of all other
registered representatives and in a manner consistent with NYSE Rule
342; (2) a copy of the written agreement between the independent
contractor and the member organization must be submitted to the
Exchange which provides that the independent contractor will engage in
securities-related activities solely on behalf of the member
organization (except as otherwise explicitly permitted by the member
organization in writing); that such securities-related activities will
be subject to the direct, detailed supervision, control and discipline
of the member organization; that the person is not subject to a
``statutory disqualification'' as defined in Section 3(a)(39) of the
Act \7\ and that nothing therein will negate any of the foregoing; (3)
the prospective independent contractor must submit an undertaking
subjecting himself to the jurisdiction of the Exchange; and (4) the
member organization must provide the Exchange assurances that the
prospective independent contractor is covered by the organization's
fidelity insurance and that the independent contractor is in compliance
with applicable state Blue Sky provisions.
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    \7\ See 15 U.S.C. 78c(a)(39).
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    The NYSE is eliminating the requirement that member organizations
submit separate written representations to the Exchange for approval of
proposed independent contractor arrangements. The amended
Interpretation retains current requirements with respect to regulatory
expectations regarding the arrangements. Accordingly, the proposed
amendments would continue to specifically require compliance with the
following regulatory requirements:
    The member organization must directly supervise and control all
activities effected on its behalf by independent contractors to the
same degree and extent that it is required to regulate the activities
of all other persons registered with the member organization consistent
with NYSE Rule 342 and all other applicable Exchange rules.\8\ For
example: (a) The member organization must ensure that any permitted
dual employment arrangement involving an independent contractor be in
compliance with NYSE Rule 346 (``Limitations--Employment and
Association with Members and Member Organizations''); (b) the member
organization must ensure that independent contractors are covered by
the organization's fidelity insurance bond, determine whether such
persons are subject to a ``statutory disqualification'' and ensure that
independent contractors are in compliance with applicable state Blue
Sky provisions; and (c) the member organization must ensure that the
initiation and cessation of independent contractor status and other
required amendments be appropriately and timely evidenced via Form U4
(``Uniform Application for Securities Industry Registration or
Transfer'') or U5 (``Uniform Termination for Securities Industry
Registration''), as applicable.\9\ Independent contractor status must
be indicated on Form U4 at the time of initial registration. If the
status is discontinued, either by termination of the relationship or by
the independent contractor becoming an employee, Form U4 must be
amended promptly.
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    \8\ The Exchange notes that this would explicitly confirm that
the standard of supervision for registered independent contractors
is identical to that of registered employees, since the supervisory
requirements of NYSE Rule 342 apply to member organizations and
their employees.
    \9\ Form U4 is the uniform form used to register personnel in
the securities industry. Form U4 is filed with Web CRD, the system
developed jointly by the National Association of Securities Dealers
and the North American Securities Administrators Association to
register associated persons. Form U4, among other things, requires
an associated person to state whether he is an independent
contractor. By signing Form U4, an associated person acknowledges
that he is subject to the rules of the self-regulatory organization
(``SRO'') with which he is registering as well as to the securities
laws.
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    Further, the proposed amendments would require member organizations
to obtain the written attestation of each individual seeking to assert
independent contractor status that he will be subject to the direct,
detailed supervision, control and discipline of the member
organization; will be bound by the relevant rules, standards and
guidelines of the member organization; and will be deemed an employee
of the member organization and, as such, will be fully subject to the
jurisdiction of the Exchange. The proposed amendments retain an updated
\10\ version of a ``Consent to Jurisdiction'' form that would be
required for this purpose. Though member organizations will no longer
need to submit executed Consent to Jurisdiction forms to the Exchange
for approval, member organizations would be required to retain them
along with the corresponding independent contractor agreement and
timely provide them to the Exchange upon request.
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    \10\ The amendments to ``Consent to Jurisdiction'' consist of
the deletion of dated references (such as the ``Constitution'' of
the Exchange); replacing the term ``registered representative'' with
the term ``registered person'' to reflect the proposed amendment
that would eliminate the prohibition against supervisory persons
asserting independent contractor status; and non-substantive changes
that improve it stylistically.
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    The current Interpretation limits the application of independent
contractor status to persons without supervisory responsibilities.\11\
The proposed amendments would remove the prohibition against
supervisory persons asserting the status of independent contractor,
except for those persons designated as principal executive officers
(e.g., Chief Executive Officer, Chief Financial Officer, Chief
Operations Officer, etc.) who must

remain direct employees of the member organization given their unique
senior principal executive responsibilities over the various areas of
their associated member organization.\12\
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    \11\ That prohibition has been relaxed as to registered
representatives ``in charge'' of an office under NYSE Rule 342.15.
See Securities Exchange Act Release No. 48762 (November 7, 2003), 68
FR 64942 (November 17, 2003) (SR-NYSE-2003-26).
    \12\ See NYSE Rule 311(b)(5) and its Interpretation.
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III. Discussion

    After careful consideration, the Commission finds that the proposed
rule change, as amended, is consistent with the requirements of the Act
and the rules and regulations thereunder applicable to a national
securities exchange \13\ and, in particular, the requirements of
Section 6 of the Act.\14\ Specifically, the Commission finds that the
proposed rule change is consistent with Section 6(b)(5) of the Act,\15\
which requires, among other things, that the rules of a national
securities exchange be designed to prevent fraudulent and manipulative
acts and practices, to promote just and equitable principles of trade,
to foster cooperation and coordination with persons engaged in
regulating, clearing, settling, and processing information with respect
to, and facilitating transactions in securities, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest.
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    \13\ In approving this proposed rule change, as amended, the
Commission has considered the proposed rule's impact on efficiency,
competition, and capital formation. 15 U.S.C. 78c(f).
    \14\ 15 U.S.C. 78f.
    \15\ 15 U.S.C. 78f(b)(5).
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    The Commission believes that the proposed rule change should reduce
unnecessary administrative burdens on the NYSE as well as member
organizations. Persons who assert independent contractor status are
subject to the member organizations' internal policies and procedures
and the jurisdictional reach of the Exchange to the same extent as any
other registered person. The Exchange would still receive notice of
independent contractor arrangements. The Rule helps ensure that member
organizations are aware of their responsibility to supervise
independent contractors.
    Specifically, the revised Form U4: (1) Obviates the need to submit
duplicative notice because the Form U4 provides the Exchange prompt
notice and an up-to-date record of such persons \16\ by requiring the
identification by registered persons of independent contractor status;
and (2) establishes jurisdictional reach by requiring registered
persons who seek to become associated with a member organization to
``submit to the authority of the jurisdictions and SROs and agree to
comply with all provisions, conditions and covenants of the statutes,
constitutions, certificates of incorporation, by-laws and rules and
regulations of the jurisdictions and SROs as they are or may be
adopted, or amended from time to time.'' \17\
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    \16\ NYSE Rule 345.12 provides, in part, that an application for
a natural person required to be registered with the Exchange shall
be submitted on Form U4 and that information on Form U4 must be kept
current and shall be updated by filing with the Exchange an
amendment to that filing.
    \17\ See Form U4, Subsection 2 of Section 15A (Individual/
Applicant's Acknowledgement and Consent).
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    The Exchange believes that permitting supervisors to assert
independent contractor status should not affect the individual's
ability to supervise, nor would it reduce accountability for failure to
fulfill their supervisory, regulatory, and other professional
obligations. The Commission notes that regardless of whether an
individual is deemed an independent contractor, he will be required to
have the same qualifications and act in the same capacity as any other
person similarly charged with supervisory responsibilities.
    Finally, the Commission reiterates its longstanding position that
the designation of an independent contractor has no relevance for
purposes of the securities laws.\18\ In this regard, the Commission
notes that member organizations may not avoid their obligation to
control and supervise the activities of their registered persons by
designating them as independent contractors.\19\
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    \18\ See letter to Gordon S. Macklin, President, NASD, Charles
J. Henry, Chicago Board Options Exchange, Robert J. Birnbaum,
American Stock Exchange and John J. Phelan, NYSE from Douglas
Scarff, Director, Division of Market Regulation, dated June 18,
1982.
    \19\ See Section 15(b)(4)(E) of the Act, 15 U.S.C. 78o(b)(4)(E).
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IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\20\ that the proposed rule change (File No. SR-NYSE-2006-05), as
amended, is hereby approved.
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    \20\ 15 U.S.C. 78s(b)(2).
    \21\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\21\
Nancy M. Morris,
Secretary.
 [FR Doc. E6-9986 Filed 6-23-06; 8:45 am]

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