[Federal Register Volume 84, Number 40 (Thursday, February 28, 2019)]
[Rules and Regulations]
[Pages 6674-6675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03514]



[[Page 6674]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2017-F-4511]


Food Additives Permitted in Feed and Drinking Water of Animals; 
Gamma-Linolenic Acid Safflower Oil

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is 
amending the regulations for food additives permitted in feed and 
drinking water of animals to provide for the safe use of gamma-
linolenic acid safflower oil (GLA safflower oil) as a source of omega-6 
fatty acids in dry food for adult cats in the maintenance life stage. 
This action is in response to a food additive petition filed by Arcadia 
Biosciences, Inc.

DATES: This rule is effective February 28, 2019. 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 April 1, 2019.

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 April 
1, 2019. The https://www.regulations.gov electronic filing system will 
accept comments until 11:59 p.m. Eastern Time at the end of April 1, 
2019. 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-2017-F-4511 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: Carissa Doody, Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV-228), 
Rockville, MD 20855, 240-402-6283, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In a document published in the Federal Register of September 14, 
2017 (82 FR 43197), FDA announced that we had filed a food additive 
petition (animal use) (FAP 2302) 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 GLA 
safflower oil as a source of omega-6 fatty acids in dry food for adult 
cats in the maintenance life stage.
    The petition for the safe use of GLA safflower oil as a source of 
omega-6 fatty acids in dry food for adult cats in the maintenance life 
stage (FAP 2302) indicated that the concentration of gamma-linolenic 
acid was between 350 and 450 milligrams (mg) gamma-linolenic acid per 
gram of the additive or the safflower oil blend. A previous petition 
(FAP 2275) that provided for the safe use of GLA safflower oil as a 
source of omega-6 fatty acids in dry food for adult dogs in the 
maintenance life stage indicated that the concentration of gamma-
linolenic acid was between 400 and 450 mg gamma-linolenic acid per gram 
of the additive or the safflower oil blend (82 FR 38595, August 15, 
2017).
    In amending Sec.  573.492 (21 CFR 573.492) to allow for the safe 
use of GLA safflower oil in dry food for adult cats, the current 
allowable concentration

[[Page 6675]]

range for gamma-linolenic acid in the additive or the safflower oil 
blend was amended to incorporate the broader range supported by FAP 
2302. This does not adversely alter the technical effect from use of 
the additive in adult maintenance dog food because provisions in the 
August 15, 2017, rule (82 FR 38597), revised in paragraph (b)(2) of 
this rule, specify that adjustments must be made for differing 
concentrations of gamma-linolenic acid to meet other specified 
parameters.

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 dry food for adult 
cats in the maintenance life stage 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. 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. Revise Sec.  573.492 to read as follows:


Sec.  573.492  Gamma-linolenic acid safflower oil.

    The food additive, gamma-linolenic acid safflower oil, may be 
safely used in animal food as a source of gamma-linolenic acid and 
other omega-6 fatty acids in accordance with the following conditions:
    (a) The additive is the oil obtained from whole seeds and/or 
partially dehulled seeds of 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 
gamma-linolenic acid (all-cis-6,9,12-octadecatrienoic acid) during seed 
development.
    (1) The additive 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 additive or the safflower oil blend is 
not less than 99.5 percent.
    (ii) Gamma-linolenic acid content is between 350 and 450 milligrams 
(mg) gamma-linolenic acid per gram of the additive or the safflower oil 
blend.
    (iii) Total content of stearidonic acid and cis, cis-6,9-
octadecadienoic acid in the additive or the safflower oil blend must 
not exceed a total of 0.3 percent.
    (b) Addition of the additive, or the safflower oil blend, to 
complete dry adult maintenance dog food must meet the following:
    (1) Addition of the additive or the safflower oil blend cannot 
provide more than 36 mg gamma-linolenic acid per kilogram body weight 
of the dog per day in more than 86 mg of the additive or the safflower 
oil blend. This maximum addition rate of the additive, or the safflower 
oil 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.
    (2) Adjustments must be made for differing concentrations of gamma-
linolenic acid and 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.
    (c) Addition of the additive, or the safflower oil blend, to 
complete dry adult maintenance cat food must meet the following:
    (1) Addition of the additive or the safflower oil blend cannot 
provide more than 33 mg gamma-linolenic acid per kilogram body weight 
of the cat per day in more than 79 mg of the additive or the safflower 
oil blend. This maximum addition rate of the additive, or the safflower 
oil blend, is 0.5 percent of a complete dry adult maintenance cat food 
containing 4,000 kilocalories of metabolizable energy per kilogram of 
food as-fed.
    (2) Adjustments must be made for differing concentrations of gamma-
linolenic acid and for cat food formulas of different caloric density 
and/or that are fed to specific weights, breeds, or cats of different 
activity levels to meet the requirements of this paragraph.
    (d) 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 of the additive, gamma-linolenic acid safflower oil, 
or GLA safflower oil;
    (2) A guarantee for the minimum content of gamma-linolenic acid; 
and
    (3) Adequate directions for use such that the finished animal food 
complies with the provisions of paragraphs (b) and (c) of this section.

    Dated: February 22, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03514 Filed 2-27-19; 8:45 am]
 BILLING CODE 4164-01-P