[Federal Register Volume 80, Number 119 (Monday, June 22, 2015)]
[Rules and Regulations]
[Pages 35568-35570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15220]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2010-F-0537]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA 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 seed meal from 
a variety of bioengineered safflower in cattle and poultry feeds. This 
action is in response to a food additive petition filed by Arcadia 
Biosciences, Inc.

DATES: This rule is effective June 22, 2015. Submit either written or 
electronic objections and requests for a hearing by July 22, 2015. See 
section V of this document for information on the filing of objections.

ADDRESSES: You may submit either electronic or written objections and a 
request for a hearing, identified by

[[Page 35569]]

Docket No. FDA-2010-F-0537, by any of the following methods:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written objections in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and docket number for this rulemaking. All objections received will be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
objections, see the ``Objections'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
objections received, go to http://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 Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Isabel W. Pocurull, Center for 
Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-402-5877, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In a notice published in the Federal Register of October 20, 2010 
(75 FR 64733), FDA announced that a food additive petition (animal use) 
(FAP 2267) had been filed by Arcadia Biosciences, Inc., 202 Cousteau 
Pl., suite 105, Davis, CA 95618. The petition proposed to amend the 
food additive regulations to provide for the safe use of seed meal from 
a variety of bioengineered safflower (Carthamus tinctorius L.) in 
cattle and poultry feeds. The safflower variety has been bioengineered 
to contain a gene from the water mold Saprolegnia diclina responsible 
for production of gamma-linolenic acid in the seed oil. Seed meals are 
the ground residues obtained after processing seeds to extract their 
oil and are a common ingredient in livestock feed. The notice of filing 
provided for a 30-day comment period on the petitioner's environmental 
assessment.

II. Conclusion

    FDA concludes that the data establish the safety and utility of 
gamma-linolenic acid safflower meal for use as proposed and that the 
food additive regulations should be amended as set forth in this 
document.

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 carefully considered the potential environmental 
impact of this action and has concluded that the action will not have a 
significant impact on the human environment and that an environmental 
impact statement is not required. FDA's finding of no significant 
impact and the evidence supporting that finding, contained in an 
environmental assessment, may be seen in the Division of Dockets 
Management (address above) between 9 a.m. and 4 p.m., Monday through 
Friday.

V. Objections and Hearing Requests

    Any person who will be adversely affected by this regulation may 
file with the Division of Dockets Management (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.
    It is only necessary to send one set of documents. Identify 
documents with the docket number found in brackets in the heading of 
this document. Any objections received in response to the regulation 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://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 and 
redelegated to the Center for Veterinary Medicine, 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 21 CFR part 573 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 342, 348.


0
2. Add Sec.  573.490 to read as follows:


Sec.  573.490  Gamma-linolenic acid safflower meal.

    The food additive consists of the meal obtained after the removal 
of most of the oil 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 gamma-linolenic acid 
during seed development. The resulting additive may be safely used in 
cattle and poultry feeds in accordance with the following prescribed 
conditions:
    (a) The additive shall contain not less than 20 percent crude 
protein, not more than 40 percent crude fiber, not more than 10 percent 
moisture, and not more than 2 percent crude fat.
    (b) The crude fat in the additive meets the following 
specifications:
    (1) Gamma-linolenic acid content not to exceed 55 percent.
    (2) Total content of stearidonic acid and cis, cis-6, 9-
octadecadienoic acid not to exceed a total of 0.5 percent.
    (3) Total content of palmitic, stearic, oleic, linoleic, and other 
associated fatty acids to exceed a total of 40 percent.
    (c) The additive is used or intended for use in cattle and poultry 
feeds as a source of protein in accordance with good manufacturing and 
feeding practices.
    (d) To assure safe use of the additive, in addition to the other 
information required by the Food, Drug, and Cosmetic Act, the label and 
labeling of

[[Page 35570]]

the additive, any feed premix, or complete feed shall bear the 
following:
    (1) The name of the additive or the common name, safflower meal.
    (2) Adequate directions for use in cattle and poultry feeds.
    (e) The additive may be identified by the common or usual name, 
safflower meal.

    Dated: June 16, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-15220 Filed 6-19-15; 8:45 am]
 BILLING CODE 4164-01-P