Food Additives Permitted in Feed and Drinking Water of Animals; Marine Microalgae, 19934-19935 [2018-09636]
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19934
Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Rules and Regulations
Environmental Review
The FAA has determined that this
action qualifies for categorical exclusion
under the National Environmental
Policy Act in accordance with FAA
Order 1050.1F, ‘‘Environmental
Impacts: Policies and Procedures,’’
paragraph 5–6.5.a. This airspace action
is not expected to cause any potentially
significant environmental impacts, and
no extraordinary circumstances exist
that warrant preparation of an
environmental assessment.
Airspace, Incorporation by reference,
Navigation (air).
Adoption of the Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for part 71
continues to read as follows:
■
Authority: 49 U.S.C. 106(f), 106(g); 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order 7400.11B,
Airspace Designations and Reporting
Points, dated August 3, 2017, and
effective September 15, 2017, is
amended as follows:
■
Paragraph 6005 Class E Airspace Areas
Extending Upward From 700 Feet or More
Above the Surface of the Earth.
*
*
*
daltland on DSKBBV9HB2PROD with RULES
AGL WI E5
*
*
Milwaukee, WI [Amended]
General Mitchell International Airport, WI
(Lat. 42°56′49″ N, long. 87°53′49″ W)
Batten International Airport, WI
(Lat. 42°45′40″ N, long. 87°48′50″ W)
Waukesha County Airport, WI
(Lat. 43°02′28″ N, long. 88°14′13″ W)
Lawrence J. Timmerman Airport, WI
(Lat. 43°06′37″ N, long. 88°02′04″ W)
That airspace extending upward from 700
feet above the surface within an 8.4-mile
radius of General Mitchell International
Airport, and within a 6.6-mile radius of
Batten International Airport, and within a
7.5-mile radius of Waukesha County Airport,
and within 2 miles each side of the 282°
bearing from Waukesha County Airport
extending from the 7.5-mile radius to 10.5
miles west of Waukesha County Airport, and
within an 8.9-mile radius of Lawrence J.
Timmerman Airport.
VerDate Sep<11>2014
16:29 May 04, 2018
Jkt 244001
[FR Doc. 2018–09561 Filed 5–4–18; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
Lists of Subjects in 14 CFR Part 71
§ 71.1
Issued in Fort Worth, Texas, on April 30,
2018.
Christopher L. Southerland,
Acting Manager, Operations Support Group,
ATO Central Service Center.
[Docket No. FDA–2014–F–1509]
Food Additives Permitted in Feed and
Drinking Water of Animals; Marine
Microalgae
AGENCY:
Food and Drug Administration,
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’’).
HHS.
Written/Paper Submissions
Submit written/paper submissions as
follows:
SUMMARY: The Food and Drug
• Mail/Hand delivery/Courier (for
Administration (FDA, we, or the
Agency) is amending the regulations for written/paper submissions): Dockets
Management Staff (HFA–305), Food and
food additives permitted in feed and
drinking water of animals to provide for Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
the safe use of dried marine microalgae
• For written/paper objections
as a source of docosahexaenoic acid
submitted to the Dockets Management
(DHA) for use in complete, dry foods for
adult dogs. This action is in response to Staff, FDA will post your objection, as
well as any attachments, except for
a food additive petition filed by DSM
information submitted, marked and
Nutritional Products.
identified, as confidential, if submitted
DATES: This rule is effective May 7,
as detailed in ‘‘Instructions.’’
2018. See section V of this document for
Instructions: All submissions received
further information on the filing of
must include the Docket No. FDA–
objections. Submit either electronic or
2014–F–1509 for ‘‘Food Additives
written objections and requests for a
Permitted in Feed and Drinking Water
hearing on the final rule by June 6,
of Animals; Marine Microalgae.’’
2018.
Received objections, those filed in a
timely manner (see ADDRESSES), will be
ADDRESSES: You may submit objections
placed in the docket and, except for
and requests for a hearing as follows.
those submitted as ‘‘Confidential
Please note that late, untimely filed
Submissions,’’ publicly viewable at
objections will not be considered.
Electronic objections must be submitted https://www.regulations.gov or at the
Dockets Management Staff between 9
on or before June 6, 2018. The https://
a.m. and 4 p.m., Monday through
www.regulations.gov electronic filing
Friday.
system will accept comments until
• Confidential Submissions—To
midnight Eastern Time at the end of
submit an objection with confidential
June 6, 2018. Objections received by
mail/hand delivery/courier (for written/ information that you do not wish to be
made publicly available, submit your
paper submissions) will be considered
objections only as a written/paper
timely if they are postmarked or the
delivery service acceptance receipt is on submission. You should submit two
copies in total. One copy will include
or before that date.
the information you claim to be
Electronic Submissions
confidential with a heading or cover
note that states ‘‘THIS DOCUMENT
Submit electronic objections in the
CONTAINS CONFIDENTIAL
following way:
• Federal eRulemaking Portal: https:// INFORMATION.’’ The Agency will
review this copy, including the claimed
www.regulations.gov. Follow the
confidential information, in its
instructions for submitting objections.
consideration of objections. The second
Objections submitted electronically,
copy, which will have the claimed
including attachments, to https://
confidential information redacted/
www.regulations.gov will be posted to
ACTION:
PO 00000
Final rule.
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07MYR1
Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Rules and Regulations
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 objections 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper objections
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.
FOR FURTHER INFORMATION CONTACT:
Chelsea Trull, Center for Veterinary
Medicine, Food and Drug
Administration, 7519 Standish Pl.
(HFV–224), Rockville, MD 20855, 240–
402–6729, chelsea.trull@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
daltland on DSKBBV9HB2PROD with RULES
I. Background
In a document published in the
Federal Register of October 16, 2014 (79
FR 62090), FDA announced that we had
filed a food additive petition (animal
use) (FAP 2288) submitted by DSM
Nutritional Products, 45 Waterview
Blvd., Parsippany, NJ 07054. The
petition proposed that the regulations
for food additives permitted in feed and
drinking water of animals be amended
to provide for the safe use of
Schizochytrium sp. dried marine
microalgae as a source of DHA for use
in complete, dry foods for adult dogs.
II. Conclusion
FDA concludes that the data establish
the safety and utility of Schizochytrium
sp. dried marine microalgae as a source
of DHA for use in complete, dry foods
for adult dogs and that the food additive
regulations should be amended as set
forth in this document. This is not a
significant regulatory action subject to
Executive Order 12866.
III. Public Disclosure
In accordance with § 571.1(h) (21 CFR
571.1(h)), the petition and documents
VerDate Sep<11>2014
16:29 May 04, 2018
Jkt 244001
we considered and relied upon in
reaching our decision to approve the
petition will be made available for
inspection at the Center for Veterinary
Medicine by appointment with the
information contact person (see FOR
FURTHER INFORMATION CONTACT). As
provided in § 571.1(h), we will delete
from the documents any materials that
are not available for public disclosure
before making the documents available
for inspection.
IV. Analysis of Environmental Impact
The Agency has determined under 21
CFR 25.32(r) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
V. Objections and Hearing Requests
Any person who will be adversely
affected by this regulation may file with
the Dockets Management Staff (see
ADDRESSES) either electronic or written
objections. Each objection shall be
separately numbered, and each
numbered objection shall specify with
particularity the provision of the
regulation to which objection is made
and the grounds for the objection. Each
numbered objection on which a hearing
is requested shall specifically so state.
Failure to request a hearing for any
particular objection shall constitute a
waiver of the right to a hearing on that
objection. Each numbered objection for
which a hearing is requested shall
include a detailed description and
analysis of the specific factual
information intended to be presented in
support of the objection in the event
that a hearing is held. Failure to include
such a description and analysis for any
particular objection shall constitute a
waiver of the right to a hearing on the
objection.
List of Subjects in 21 CFR Part 573
Animal feeds, Food additives.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 573 is
amended as follows:
PART 573—FOOD ADDITIVES
PERMITTED IN FEED AND DRINKING
WATER OF ANIMALS
§ 573.615
Marine microalgae.
The food additive, marine microalgae,
may be safely used as a source of
docosahexaenoic acid (DHA) and other
omega-3 fatty acids in accordance with
the following prescribed conditions:
(a) The additive is dried whole cells
of nonviable, nontoxigenic,
nonpathogenic Schizochytrium sp. algae
grown as a pure culture.
(b) The additive is used in complete,
dry adult maintenance food for dogs in
accordance with good manufacturing
and feeding practices not to exceed 16.5
pounds per ton (7.5 kilograms (kg) per
1000 kg) of complete, dry, adult
maintenance dog food.
(c) The additive consists of not less
than 17.0 percent
(4Z,7Z,10Z,13Z,16Z,19Z)-docosa4,7,10,13,16,19-hexaenoic acid
(docosahexaenoic acid or DHA).
(d) The additive meets the following
specifications:
(1) Not less than 40 percent crude fat;
(2) Not more than 12 percent ash;
(3) Not more than 8 percent
unsaponifiable matter;
(4) Not more than 5 percent insoluble
impurities;
(5) Not more than 5 percent free fatty
acids; and
(6) Not more than 6 percent water.
(e) To ensure the safe use of the
additive, in addition to other
information required by the Federal
Food, Drug, and Cosmetic Act:
(1) The label and labeling of the
additive, any feed premix, and complete
feed, shall contain the name of the
additive, marine microalgae.
(2) The label and labeling of the
additive and any feed premix shall also
contain:
(i) A statement to indicate that the
maximum use level of the additive shall
not exceed 16.5 pounds per ton (7.5 kg
per 1000 kg) of complete, dry, adult
maintenance dog food.
(ii) Adequate directions for use.
Dated: May 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–09636 Filed 5–4–18; 8:45 am]
BILLING CODE 4164–01–P
1. The authority citation for part 573
continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 348.
2. Add § 573.615 to subpart B to read
as follows:
■
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Agencies
[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Rules and Regulations]
[Pages 19934-19935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09636]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2014-F-1509]
Food Additives Permitted in Feed and Drinking Water of Animals;
Marine Microalgae
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is
amending the regulations for food additives permitted in feed and
drinking water of animals to provide for the safe use of dried marine
microalgae as a source of docosahexaenoic acid (DHA) for use in
complete, dry foods for adult dogs. This action is in response to a
food additive petition filed by DSM Nutritional Products.
DATES: This rule is effective May 7, 2018. See section V of this
document for further information on the filing of objections. Submit
either electronic or written objections and requests for a hearing on
the final rule by June 6, 2018.
ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections will not be
considered. Electronic objections must be submitted on or before June
6, 2018. The https://www.regulations.gov electronic filing system will
accept comments until midnight Eastern Time at the end of June 6, 2018.
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 objections. 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-2014-F-1509 for ``Food Additives Permitted in Feed and Drinking
Water of Animals; Marine Microalgae.'' 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.
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 in 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.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of objections. The second copy, which
will have the claimed confidential information redacted/
[[Page 19935]]
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 objections 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.gpo.gov/fdsys/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 objections 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.
FOR FURTHER INFORMATION CONTACT: Chelsea Trull, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV-224),
Rockville, MD 20855, 240-402-6729, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In a document published in the Federal Register of October 16, 2014
(79 FR 62090), FDA announced that we had filed a food additive petition
(animal use) (FAP 2288) submitted by DSM Nutritional Products, 45
Waterview Blvd., Parsippany, NJ 07054. The petition proposed that the
regulations for food additives permitted in feed and drinking water of
animals be amended to provide for the safe use of Schizochytrium sp.
dried marine microalgae as a source of DHA for use in complete, dry
foods for adult dogs.
II. Conclusion
FDA concludes that the data establish the safety and utility of
Schizochytrium sp. dried marine microalgae as a source of DHA for use
in complete, dry foods for adult dogs and that the food additive
regulations should be amended as set forth in this document. This is
not a significant regulatory action subject to Executive Order 12866.
III. Public Disclosure
In accordance with Sec. 571.1(h) (21 CFR 571.1(h)), the petition
and documents we considered and relied upon in reaching our decision to
approve the petition will be made available for inspection at the
Center for Veterinary Medicine by appointment with the information
contact person (see FOR FURTHER INFORMATION CONTACT). As provided in
Sec. 571.1(h), we will delete from the documents any materials that
are not available for public disclosure before making the documents
available for inspection.
IV. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.32(r) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
V. Objections and Hearing Requests
Any person who will be adversely affected by this regulation may
file with the Dockets Management Staff (see ADDRESSES) either
electronic or written objections. Each objection shall be separately
numbered, and each numbered objection shall specify with particularity
the provision of the regulation to which objection is made and the
grounds for the objection. Each numbered objection on which a hearing
is requested shall specifically so state. Failure to request a hearing
for any particular objection shall constitute a waiver of the right to
a hearing on that objection. Each numbered objection for which a
hearing is requested shall include a detailed description and analysis
of the specific factual information intended to be presented in support
of the objection in the event that a hearing is held. Failure to
include such a description and analysis for any particular objection
shall constitute a waiver of the right to a hearing on the objection.
List of Subjects in 21 CFR Part 573
Animal feeds, Food additives.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
573 is amended as follows:
PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF
ANIMALS
0
1. The authority citation for part 573 continues to read as follows:
Authority: 21 U.S.C. 321, 342, 348.
0
2. Add Sec. 573.615 to subpart B to read as follows:
Sec. 573.615 Marine microalgae.
The food additive, marine microalgae, may be safely used as a
source of docosahexaenoic acid (DHA) and other omega-3 fatty acids in
accordance with the following prescribed conditions:
(a) The additive is dried whole cells of nonviable, nontoxigenic,
nonpathogenic Schizochytrium sp. algae grown as a pure culture.
(b) The additive is used in complete, dry adult maintenance food
for dogs in accordance with good manufacturing and feeding practices
not to exceed 16.5 pounds per ton (7.5 kilograms (kg) per 1000 kg) of
complete, dry, adult maintenance dog food.
(c) The additive consists of not less than 17.0 percent
(4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenoic acid
(docosahexaenoic acid or DHA).
(d) The additive meets the following specifications:
(1) Not less than 40 percent crude fat;
(2) Not more than 12 percent ash;
(3) Not more than 8 percent unsaponifiable matter;
(4) Not more than 5 percent insoluble impurities;
(5) Not more than 5 percent free fatty acids; and
(6) Not more than 6 percent water.
(e) To ensure the safe use of the additive, in addition to other
information required by the Federal Food, Drug, and Cosmetic Act:
(1) The label and labeling of the additive, any feed premix, and
complete feed, shall contain the name of the additive, marine
microalgae.
(2) The label and labeling of the additive and any feed premix
shall also contain:
(i) A statement to indicate that the maximum use level of the
additive shall not exceed 16.5 pounds per ton (7.5 kg per 1000 kg) of
complete, dry, adult maintenance dog food.
(ii) Adequate directions for use.
Dated: May 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09636 Filed 5-4-18; 8:45 am]
BILLING CODE 4164-01-P