Food Additives Permitted in Feed and Drinking Water of Animals; Gamma-Linolenic Acid Safflower Oil, 38595-38597 [2017-17214]
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Federal Register / Vol. 82, No. 156 / Tuesday, August 15, 2017 / Rules and Regulations
List of Subjects in 7 CFR Part 1205
DEPARTMENT OF AGRICULTURE
Advertising, Agricultural research,
Cotton, Marketing agreements,
Reporting and recordkeeping
requirements.
Accordingly, 7 CFR part 1205 is
amended as follows:
Agricultural Marketing Service
7 CFR Part 1205
[AMS–CN–17–0041]
Cotton Research and Promotion
Program: Procedures for Conduct of
Sign-Up Period
AGENCY:
PART 1205—COTTON RESEARCH
AND PROMOTION
Agricultural Marketing Service,
USDA.
ACTION:
Authority: 7 U.S.C. 2101–2118; 7 U.S.C
7401.
Correcting amendments.
The Agricultural Marketing
Service (AMS) is making corrections to
the Code of Federal Regulations (CFR)
by revising the authority citation for its
regulation, Cotton Research and
Promotion. In a final rule published in
the Federal Register on June 24, 2015,
changes were inadvertently made to
remove a legal citation from the
authority citation and to erroneously
include an unnecessary authority
citation after a section in AMS
regulations. This document corrects
those errors.
SUMMARY:
DATES:
Effective August 16, 2017.
FOR FURTHER INFORMATION CONTACT:
This
document provides correcting
amendments to the Cotton Research and
Promotion Order (Order), found at 7
CFR part 1205, so that complete and
appropriate authority is stated in the
Order. In a final rule published in the
Federal Register on June 24, 2015 (80
FR 36231), the rules and regulations
regarding the procedures for the
conduct of a sign-up period for eligible
cotton producers and importers to
request a continuance referendum on
the 1991 amendments to the Order were
revised. In that final rule, changes were
inadvertently made to remove ‘‘7 U.S.C.
7401’’ from the authority citation. In
addition, AMS discovered that an
irrelevant authority citation ‘‘Authority:
7 U.S.C. 2101–2118’’ occurs after
§ 1205.29(c) in the CFR. This document
corrects those errors by reinserting ‘‘7
U.S.C. 7401’’ into the authority citation
that was removed from Title 7 of the
CFR, part 1205, and by removing the
unnecessary authority citation placed
after § 1205.29(c) of the Order.
jstallworth on DSKBBY8HB2PROD with RULES
VerDate Sep<11>2014
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Jkt 241001
§ 1205.29
[Amended]
2. In § 1205.29, remove the following
language ‘‘(Authority: 7 U.S.C. 2101–
2118.)’’ from the end of the section.
■
Dated: August 9, 2017.
Bruce Summers,
Acting Administrator, Agricultural Marketing
Service.
[FR Doc. 2017–17143 Filed 8–14–17; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Shethir M. Riva, Director, Research and
Promotion Staff, Cotton and Tobacco
Program, Agricultural Marketing
Service, USDA, 100 Riverside Parkway,
Suite 101, Fredericksburg, Virginia
22406, telephone (540) 361–2726,
facsimile (540) 361–1199, or email at
Shethir.Riva@ams.usda.gov.
SUPPLEMENTARY INFORMATION:
1. The authority citation for part 1205
is revised to read as follows:
■
21 CFR Part 573
[Docket No. FDA–2012–F–0949]
Food Additives Permitted in Feed and
Drinking Water of Animals; GammaLinolenic Acid Safflower Oil
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA or 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 oil from a variety of
bioengineered safflower as a source of
omega-6 fatty acids in complete dry
adult maintenance dog food. This action
is in response to a food additive petition
filed by Arcadia Biosciences, Inc.
DATES: This rule is effective August 15,
2017. Submit either written or
electronic objections and requests for a
hearing by September 14, 2017. See the
ADDRESSES section, and SUPPLEMENTARY
INFORMATION section V of this document,
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.
SUMMARY:
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38595
Electronic objections must be submitted
on or before September 14, 2017. The
https://www.regulations.gov electronic
filing system will accept objections until
midnight Eastern Time at the end of
September 14, 2017. 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–
2012–F–0949 for ‘‘Food Additives
Permitted in Feed and Drinking Water
of Animals; Gamma-Linolenic Acid
Safflower Oil.’’ Received objections,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
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38596
Federal Register / Vol. 82, No. 156 / Tuesday, August 15, 2017 / Rules and Regulations
jstallworth on DSKBBY8HB2PROD with RULES
‘‘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/
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.,
Rockville, MD 20855, 240–402–6729,
chelsea.trull@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal
Register of September 12, 2012 (77 FR
56175), FDA announced that we had
filed a food additive petition (animal
use) (FAP 2275) submitted by Arcadia
Biosciences, Inc., 202 Cousteau Pl.,
VerDate Sep<11>2014
14:06 Aug 14, 2017
Jkt 241001
Suite 200, Davis, CA 95618. 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 oil from
a variety of bioengineered safflower
(Carthamus tinctorius L.) in complete
dry adult maintenance dog food. The
safflower variety has been
bioengineered to contain a gene from
the water mold Saprolegnia diclina
responsible for production of gammalinolenic acid (GLA) in the seed oil.
This GLA-enriched safflower oil will be
used as a source of omega-6 fatty acids
in dry food for adult dogs. The notice
of petition provided for a 30-day
comment period on the petitioner’s
request for categorical exclusion from
preparing an environmental assessment
or environmental impact statement.
II. Conclusion
FDA concludes that the data establish
the safety and utility of GLA safflower
oil as a source of omega-6 fatty acids in
complete dry adult maintenance dog
food 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
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
§ 571.1(h), we will delete from the
documents any materials that are not
available for public disclosure.
IV. 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
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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.
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.
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
1. The authority citation for part 573
continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 348.
■
2. Add § 573.492 to read as follows:
§ 573.492
oil.
Gamma-linolenic acid safflower
The food additive gamma-linolenic
acid (all-cis-6,9,12-octadecatrienoic
acid) (GLA) safflower oil contains an
omega-6 fatty acid that may be safely
used in animal food in accordance with
the following conditions:
(a) The additive GLA safflower oil is
produced in the oil obtained from whole
seeds or partially dehulled seeds or both
obtained from a Carthamus tinctorius L.
safflower Centennial variety genetically
engineered to express the delta-6desaturase gene from Saprolegnia
diclina Humphrey. The 453 amino acid,
delta-6-desaturase enzyme converts the
fatty acid linoleic acid to GLA during
seed development. This GLA safflower
oil may be safely used in complete dry
adult maintenance dog food as a source
of GLA and other omega-6 fatty acids in
accordance with the following
prescribed conditions:
(1) The GLA safflower oil obtained
from the seeds of the genetically
engineered safflower Centennial variety
may be blended with oil obtained from
seeds of non-engineered oleic acid
safflower varieties in order to meet the
specifications required for the additive
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Federal Register / Vol. 82, No. 156 / Tuesday, August 15, 2017 / Rules and Regulations
or the blend in paragraph (a)(2) of this
section.
PENSION BENEFIT GUARANTY
CORPORATION
(2) The additive or a safflower oil
blend containing the additive for use in
animal food meets the following
specifications:
(i) Crude fat content of the GLA
safflower oil or its blend is not less than
99.5 percent.
(ii) GLA content is between 400 and
450 milligrams (mg) GLA per gram of
the GLA safflower oil or its blend.
(i) Addition of the oil or its blend
cannot provide more than 36 mg GLA
per kilogram body weight of the dog per
day in more than 86 mg of the GLA
safflower oil or its blend. This
maximum addition rate of the GLA
safflower oil, or its blend, is 0.3 percent
of a complete dry adult maintenance
dog food containing 3,600 kilocalories
of metabolizable energy per kilogram of
food as-fed.
(ii) Adjustments must be made for dog
food formulas of different caloric
density and/or that are fed to specific
weights, breeds, or dogs of different
activity levels to meet the requirements
of this paragraph.
(b) To assure safe use of the additive,
in addition to other information
required by the Federal Food, Drug, and
Cosmetic Act, the label and labeling of
the additive shall bear the following:
(1) The name, gamma-linolenic acid
(GLA) safflower oil.
(2) A guarantee for the minimum
content of gamma-linolenic acid.
(3) Adequate directions for use such
that the finished animal food complies
with the provisions of paragraph (a)(3)
of this section.
jstallworth on DSKBBY8HB2PROD with RULES
BILLING CODE 4164–01–P
VerDate Sep<11>2014
17:13 Aug 14, 2017
Jkt 241001
Pension Benefit Guaranty
Corporation.
AGENCY:
Final rule.
This final rule amends the
Pension Benefit Guaranty Corporation’s
regulation on Benefits Payable in
Terminated Single-Employer Plans to
prescribe interest assumptions under
the regulation for valuation dates in
September 2017. The interest
assumptions are used for paying
benefits under terminating singleemployer plans covered by the pension
insurance system administered by
PBGC.
SUMMARY:
(3) Addition of GLA safflower oil, or
its blend, to complete dry adult
maintenance dog food must meet the
following:
[FR Doc. 2017–17214 Filed 8–14–17; 8:45 am]
Benefits Payable in Terminated SingleEmployer Plans; Interest Assumptions
for Paying Benefits
ACTION:
(iii) Total content of stearidonic acid
and cis, cis-6,9-octadecadienoic acid in
the GLA safflower oil or its blend must
not exceed a total of 0.3 percent.
Dated: August 4, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
29 CFR Part 4022
DATES:
Effective September 1, 2017.
FOR FURTHER INFORMATION CONTACT:
Deborah C. Murphy (Murphy.Deborah@
pbgc.gov), Assistant General Counsel for
Regulatory Affairs, Pension Benefit
Guaranty Corporation, 1200 K Street
NW., Washington, DC 20005, 202–326–
4400 ext. 3451. (TTY/TDD users may
call the Federal relay service toll-free at
1–800–877–8339 and ask to be
connected to 202–326–4400, ext. 3451.)
PBGC’s
regulation on Benefits Payable in
Terminated Single-Employer Plans (29
CFR part 4022) prescribes actuarial
assumptions—including interest
assumptions—for paying plan benefits
under terminated single-employer plans
covered by title IV of the Employee
Retirement Income Security Act of 1974.
The interest assumptions in the
regulation are also published on PBGC’s
Web site (https://www.pbgc.gov).
PBGC uses the interest assumptions in
Appendix B to part 4022 to determine
whether a benefit is payable as a lump
sum and to determine the amount to
pay. Appendix C to part 4022 contains
interest assumptions for private-sector
pension practitioners to refer to if they
wish to use lump-sum interest rates
determined using PBGC’s historical
methodology. Currently, the rates in
Appendices B and C of the benefit
payment regulation are the same.
The interest assumptions are intended
to reflect current conditions in the
financial and annuity markets.
Assumptions under the benefit
payments regulation are updated
monthly. This final rule updates the
SUPPLEMENTARY INFORMATION:
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38597
benefit payments interest assumptions
for September 2017.1
The September 2017 interest
assumptions under the benefit payments
regulation will be 1.00 percent for the
period during which a benefit is in pay
status and 4.00 percent during any years
preceding the benefit’s placement in pay
status. In comparison with the interest
assumptions in effect for August 2017,
these assumptions represent an increase
of 0.25 percent in the immediate rate
and are otherwise unchanged.
PBGC has determined that notice and
public comment on this amendment are
impracticable and contrary to the public
interest. This finding is based on the
need to determine and issue new
interest assumptions promptly so that
the assumptions can reflect current
market conditions as accurately as
possible.
Because of the need to provide
immediate guidance for the payment of
benefits under plans with valuation
dates during September 2017, PBGC
finds that good cause exists for making
the assumptions set forth in this
amendment effective less than 30 days
after publication.
PBGC has determined that this action
is not a ‘‘significant regulatory action’’
under the criteria set forth in Executive
Order 12866.
Because no general notice of proposed
rulemaking is required for this
amendment, the Regulatory Flexibility
Act of 1980 does not apply. See 5 U.S.C.
601(2).
List of Subjects in 29 CFR Part 4022
Employee benefit plans, Pension
insurance, Pensions, Reporting and
recordkeeping requirements.
In consideration of the foregoing, 29
CFR part 4022 is amended as follows:
PART 4022—BENEFITS PAYABLE IN
TERMINATED SINGLE-EMPLOYER
PLANS
1. The authority citation for part 4022
continues to read as follows:
■
Authority: 29 U.S.C. 1302, 1322, 1322b,
1341(c)(3)(D), and 1344.
2. In Appendix B to part 4022, Rate
Set 287, as set forth below, is added to
the table.
■
Appendix B to Part 4022—Lump Sum
Interest Rates for PBGC Payments
*
*
*
*
*
1 Appendix B to PBGC’s regulation on Allocation
of Assets in Single-Employer Plans (29 CFR part
4044) prescribes interest assumptions for valuing
benefits under terminating covered single-employer
plans for purposes of allocation of assets under
ERISA section 4044. Those assumptions are
updated quarterly.
E:\FR\FM\15AUR1.SGM
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Agencies
[Federal Register Volume 82, Number 156 (Tuesday, August 15, 2017)]
[Rules and Regulations]
[Pages 38595-38597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17214]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2012-F-0949]
Food Additives Permitted in Feed and Drinking Water of Animals;
Gamma-Linolenic Acid Safflower Oil
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or 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 oil from a
variety of bioengineered safflower as a source of omega-6 fatty acids
in complete dry adult maintenance dog food. This action is in response
to a food additive petition filed by Arcadia Biosciences, Inc.
DATES: This rule is effective August 15, 2017. Submit either written or
electronic objections and requests for a hearing by September 14, 2017.
See the ADDRESSES section, and SUPPLEMENTARY INFORMATION section V of
this document, 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. Electronic objections must be submitted on or before
September 14, 2017. The https://www.regulations.gov electronic filing
system will accept objections until midnight Eastern Time at the end of
September 14, 2017. 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-2012-F-0949 for ``Food Additives Permitted in Feed and Drinking
Water of Animals; Gamma-Linolenic Acid Safflower Oil.'' Received
objections, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as
[[Page 38596]]
``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/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., Rockville,
MD 20855, 240-402-6729, chelsea.trull@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of September 12, 2012
(77 FR 56175), FDA announced that we had filed a food additive petition
(animal use) (FAP 2275) submitted by Arcadia Biosciences, Inc., 202
Cousteau Pl., Suite 200, Davis, CA 95618. 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 oil from a variety
of bioengineered safflower (Carthamus tinctorius L.) in complete dry
adult maintenance dog food. The safflower variety has been
bioengineered to contain a gene from the water mold Saprolegnia diclina
responsible for production of gamma-linolenic acid (GLA) in the seed
oil. This GLA-enriched safflower oil will be used as a source of omega-
6 fatty acids in dry food for adult dogs. The notice of petition
provided for a 30-day comment period on the petitioner's request for
categorical exclusion from preparing an environmental assessment or
environmental impact statement.
II. Conclusion
FDA concludes that the data establish the safety and utility of GLA
safflower oil as a source of omega-6 fatty acids in complete dry adult
maintenance dog food 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 public disclosure (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.
IV. 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.
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.
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. 573.492 to read as follows:
Sec. 573.492 Gamma-linolenic acid safflower oil.
The food additive gamma-linolenic acid (all-cis-6,9,12-
octadecatrienoic acid) (GLA) safflower oil contains an omega-6 fatty
acid that may be safely used in animal food in accordance with the
following conditions:
(a) The additive GLA safflower oil is produced in the oil obtained
from whole seeds or partially dehulled seeds or both obtained from a
Carthamus tinctorius L. safflower Centennial variety genetically
engineered to express the delta-6-desaturase gene from Saprolegnia
diclina Humphrey. The 453 amino acid, delta-6-desaturase enzyme
converts the fatty acid linoleic acid to GLA during seed development.
This GLA safflower oil may be safely used in complete dry adult
maintenance dog food as a source of GLA and other omega-6 fatty acids
in accordance with the following prescribed conditions:
(1) The GLA safflower oil obtained from the seeds of the
genetically engineered safflower Centennial variety may be blended with
oil obtained from seeds of non-engineered oleic acid safflower
varieties in order to meet the specifications required for the additive
[[Page 38597]]
or the blend in paragraph (a)(2) of this section.
(2) The additive or a safflower oil blend containing the additive
for use in animal food meets the following specifications:
(i) Crude fat content of the GLA safflower oil or its blend is not
less than 99.5 percent.
(ii) GLA content is between 400 and 450 milligrams (mg) GLA per
gram of the GLA safflower oil or its blend.
(iii) Total content of stearidonic acid and cis, cis-6,9-
octadecadienoic acid in the GLA safflower oil or its blend must not
exceed a total of 0.3 percent.
(3) Addition of GLA safflower oil, or its blend, to complete dry
adult maintenance dog food must meet the following:
(i) Addition of the oil or its blend cannot provide more than 36 mg
GLA per kilogram body weight of the dog per day in more than 86 mg of
the GLA safflower oil or its blend. This maximum addition rate of the
GLA safflower oil, or its blend, is 0.3 percent of a complete dry adult
maintenance dog food containing 3,600 kilocalories of metabolizable
energy per kilogram of food as-fed.
(ii) Adjustments must be made for dog food formulas of different
caloric density and/or that are fed to specific weights, breeds, or
dogs of different activity levels to meet the requirements of this
paragraph.
(b) To assure safe use of the additive, in addition to other
information required by the Federal Food, Drug, and Cosmetic Act, the
label and labeling of the additive shall bear the following:
(1) The name, gamma-linolenic acid (GLA) safflower oil.
(2) A guarantee for the minimum content of gamma-linolenic acid.
(3) Adequate directions for use such that the finished animal food
complies with the provisions of paragraph (a)(3) of this section.
Dated: August 4, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-17214 Filed 8-14-17; 8:45 am]
BILLING CODE 4164-01-P