[Federal Register Volume 81, Number 169 (Wednesday, August 31, 2016)]
[Notices]
[Page 59993]
[FR Doc No: 2016-20980]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 10887-027]

Climax Manufacturing Company; Notice of Application Accepted for
Filing, Soliciting Comments, Protests and Motions To Intervene

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Proceeding: Extension of License Term.
    b. Project No.: P-10887-027.
    c. Date Filed: August 4, 2016.
    d. Licensee: Climax Manufacturing Company.
    e. Name and Location of Project: Carthage Paper Makers
Hydroelectric Project, located on the Black River in Jefferson and
Lewis counties, New York.
    f. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    g. Licensee Contact Information: Mr. Fred Goutremout, 30 Champion
Street, Carthage, New York 13619, Phone:<PHONE_NUMBER>.
    h. FERC Contact: Mr. Ashish Desai,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    i. Deadline for filing comments, motions to intervene and protests,
is 30 days from the issuance date of this notice by the Commission. The
Commission strongly encourages electronic filing. Please file motions
to intervene, protests, comments, and recommendations, using the
Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-10887-027.
    j. Description of Proceeding: The licensee, Climax Manufacturing
Company, requests the Commission extend the term of the license by five
years, from October 31, 2021 to October 31, 2026. The licensee received
a 20-year license for the project on October 22, 1991. The licensee
states that in order to facilitate a basin-wide relicensing approach
with several other projects, it needs the five-year extension for the
license term. The licensee states that it has consulted with the U.S.
Fish and Wildlife Service (FWS) and New York State Department of
Environmental Conservation (DEC), and coordinated with other licensees
to develop a framework for relicensing. The licensee states that the
FWS and the New York DEC support the process.
    k. This notice is available for review and reproduction at the
Commission in the Public Reference Room, Room 2A, 888 First Street NE.,
Washington, DC 20426. The filing may also be viewed on the Commission's
Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the
Docket number (P-10887-027) excluding the last three digits in the
docket number field to access the notice. You may also register online
at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via
email of new filings and issuances related to this or other pending
projects. For assistance, call toll-free 1-866-208-3676 or email
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>.
    l. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    m. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    n. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis and otherwise comply with the requirements of 18 CFR
4.34(b). All comments, motions to intervene, or protests should relate
to project works which are the subject of the license surrender.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application. If an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.

    Dated: August 25, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-20980 Filed 8-30-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 118 (Tuesday, June 19, 2012)]
[Notices]
[Pages 36534-36536]
[FR Doc No: 2012-14776]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9689-3; Docket ID No. EPA-HQ-ORD-2011-0050]

Third External Review Draft Integrated Science Assessment for
Ozone and Related Photochemical Oxidants

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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

SUMMARY: EPA is announcing the availability of the third external
review draft of a document titled, ``Third External Review Draft
Integrated Science Assessment for Ozone and Related Photochemical
Oxidants'' (EPA/600/R-10/076C). The document was prepared by the
National Center for Environmental Assessment (NCEA) within EPA's Office
of Research and Development as part of the review of the National
Ambient Air Quality Standards (NAAQS) for ozone.
    EPA is releasing this draft document to seek review by the Clean
Air Scientific Advisory Committee (CASAC) and the public (meeting date
and location to be specified in a separate Federal Register notice).
The draft document does not represent and should not be construed to
represent

any final EPA policy, viewpoint, or determination. EPA will consider
any public comments submitted in response to this notice when revising
the document.

DATES: The public comment period begins, June 19, 2012, and ends August
20, 2012. Comments must be received on or before August 20, 2012.

ADDRESSES: The ``Third External Review Draft Integrated Science
Assessment for Ozone and Related Photochemical Oxidants'' will be
available primarily via the Internet on the National Center for
Environmental Assessment's home page under the Recent Additions and
Publications menus at http://www.epa.gov/ncea. A limited number of CD-
ROM or paper copies will be available. Contact Ms. Marieka Boyd by
phone<PHONE_NUMBER>), fax<PHONE_NUMBER>), or email
<EMAIL_ADDRESS>to request either of these, and please provide
your name, your mailing address, and the document title, ``Third
External Review Draft Integrated Science Assessment for Ozone and
Related Photochemical Oxidants'' (EPA/600/R-10/076C) to facilitate
processing of your request.

FOR FURTHER INFORMATION CONTACT: For technical information, contact Dr.
James Brown, NCEA; telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Information About the Document

    Section 108 (a) of the Clean Air Act directs the Administrator to
identify certain pollutants which, among other things, ``cause or
contribute to air pollution which may reasonably be anticipated to
endanger public health or welfare'' and to issue air quality criteria
for them. These air quality criteria are to ``accurately reflect the
latest scientific knowledge useful in indicating the kind and extent of
all identifiable effects on public health or welfare which may be
expected from the presence of [a] pollutant in the ambient air. * * *''
Under section 109 of the Act, EPA is then to establish NAAQS for each
pollutant for which EPA has issued criteria. Section 109 (d) of the Act
subsequently requires periodic review and, if appropriate, revision of
existing air quality criteria to reflect advances in scientific
knowledge on the effects of the pollutant on public health or welfare.
EPA is also to periodically review and, if appropriate, revise the
NAAQS, based on the revised air quality criteria.
    Ozone (O3) is one of six principal (or ``criteria'')
pollutants for which EPA has established NAAQS. Periodically, EPA
reviews the scientific basis for these standards by preparing an
Integrated Science Assessment (ISA) (formerly called an Air Quality
Criteria Document). The ISA, in conjunction with additional technical
and policy assessments, provide the scientific basis for EPA decisions
on the adequacy of the current NAAQS and the appropriateness of
possible alternative standards. The CASAC, an independent science
advisory committee whose existence and whose review and advisory
functions are mandated by Section 109(d)(2) of the Clean Air Act, is
charged (among other things) with independent scientific review of
EPA's air quality criteria.
    On September 29, 2008 (73 FR 56581), EPA formally initiated its
current review of the air quality criteria for ozone, requesting the
submission of recent scientific information on specified topics. A
draft of EPA's ``Integrated Review Plan for the Ozone National Ambient
Air Quality Standards Review'' (EPA/452/P-09/001) was made available in
September 2009 for public comment and was discussed by the CASAC via a
publicly accessible teleconference consultation on November 13, 2009
(74 FR 54562). In August 2010, EPA held a workshop to discuss, with
invited scientific experts, initial draft materials prepared in the
development of the ISA (75 FR 42085). The first external review draft
ISA for Ozone and Related Photochemical Oxidants was released on March
4, 2011 (http://cfpub.epa.gov/ncea/isa/recordisplay.cfm?deid=217463).
The CASAC panel met at a public meeting on May 19, 2011, to review the
draft ISA (76 FR 23809). Subsequently, on August 10, 2011, the CASAC
panel provided a consensus letter for their review to the Administrator
of the EPA (http://yosemite.epa.gov/sab/sabproduct.nsf/
4620a620d0120f93852572410080d786/45A59F1BC8912FEE852578E80066021C/
$File/EPA-CASAC-11-009-unsigned.pdf). The second external review draft
ISA for Ozone and Related Photochemical Oxidants was released on
September 30, 2011 (http://cfpub.epa.gov/ncea/isa/recordisplay.cfm?deid=226363). The CASAC panel met at a public meeting
on January 9, 2012, to review the draft ISA (76 FR 76725).
Subsequently, on March 13, 2012, the CASAC panel provided a consensus
letter for their review to the Administrator of the EPA (http://
yosemite.epa.gov/sab/sabproduct.nsf/4620a620d0120f93852572410080d786/
1336B2B88034AEB6852579C0007070CA/$File/EPA-CASAC-12-004-unsigned.pdf).
    The third external review draft ISA for Ozone and Related
Photochemical Oxidants will be discussed at a public meeting for review
by CASAC, and public comments received will be provided to the CASAC
review panel. A future Federal Register notice will inform the public
of the exact date and time of that CASAC meeting.

II. How to Submit Technical Comments to the Docket at
www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2011-
0050 by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 28221T), U.S. Environmental Protection Agency, 1200
Pennsylvania Avenue NW., Washington, DC 20460. The phone number is 202-
566-1752.
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334, 1301
Constitution Avenue NW., Washington, DC. The EPA Docket Center 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>. Such deliveries are only accepted during
the docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information. If you provide comments by
mail or hand delivery, please submit three copies of the comments. For
attachments, provide an index, number pages consecutively with the
comments, and submit an unbound original and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2011-0050. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at
www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information through
www.regulations.gov or email that you consider to be CBI or otherwise
protected. The www.regulations.gov Web site is an ``anonymous access''

system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center home page at www.epa.gov/epahome/dockets.htm.
    Docket: Documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the OEI Docket in the EPA
Headquarters Docket Center.

    Dated: June 7, 2012.
Rebecca Clark,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 2012-14776 Filed 6-18-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 102 (Friday, May 28, 2021)]
[Notices]
[Pages 28821-28822]
[FR Doc No: 2021-11362]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER21-1961-000]

Big River Solar, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced Big River
Solar, LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is June 14, 2021.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number

field to access the document. At this time, the Commission has
suspended access to the Commission's Public Reference Room, due to the
proclamation declaring a National Emergency concerning the Novel
Coronavirus Disease (COVID-19), issued by the President on March 13,
2020. For assistance, contact the Federal Energy Regulatory Commission
at<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.

    Dated: May 24, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-11362 Filed 5-27-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 156 (Tuesday, August 15, 2017)]
[Rules and Regulations]
[Pages 38595-38597]
[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

``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,<PHONE_NUMBER><EMAIL_ADDRESS>
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

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