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Daily Rules, Proposed Rules, and Notices of the Federal Government

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.
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, CA95618. The petition proposes to amend Title 21 of the Code of Federal Regulations (CFR) in part 573Food 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 tinctoriusL.). The safflower variety has been bioengineered to contain a gene from the water moldSaprolegnia diclinaresponsible 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 (seeDATESandADDRESSES). 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.