
[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


