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.
Director, Center for Veterinary Medicine.