[Federal Register Volume 77, Number 177 (Wednesday, September 12, 2012)]
[Proposed Rules]
[Pages 56175-56176]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22422]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2012-F-0949]


Arcadia Biosciences, Inc.; Filing of Food Additive Petition 
(Animal Use)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that 
Arcadia Biosciences, Inc., has filed a petition proposing that the food 
additive regulations be amended to provide for the safe use in dry dog 
food of oil from a variety of bioengineered safflower.

DATES: Submit either electronic or written comments on the petitioner's 
request for categorical exclusion from preparing an environmental 
assessment or environmental impact statement by October 12, 2012.

ADDRESSES: Submit electronic comments to: http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 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, 240-453-6853, Email: 
isabel.pocurull@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under section 409(b)(5) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), notice is given that a 
food additive petition (FAP 2275) has been filed by Arcadia 
Biosciences, Inc., 202 Cousteau Place, suite 200, Davis, CA

[[Page 56176]]

95618. The petition proposes to amend Title 21 of the Code of Federal 
Regulations (CFR) in part 573 Food Additives Permitted in Feed and 
Drinking Water of Animals (21 CFR part 573) to provide for the safe use 
in dry dog food of oil from a variety of bioengineered safflower 
(Carthamus tinctorius L.). 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 petitioner has requested a categorical exclusion from preparing 
an environmental assessment or environmental impact statement under 21 
CFR 25.32(r). Interested persons may submit a single copy of either 
electronic or written comments regarding this request for categorical 
exclusion to the Division of Dockets Management (see DATES and 
ADDRESSES). Identify comments with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: September 7, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-22422 Filed 9-11-12; 8:45 am]
BILLING CODE 4160-01-P