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Final Rule.
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.
TABLE OF CONTENTS
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DATES:
ADDRESSES:
Electronic Submissions
Written Submissions
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Background
II. Conclusion
III. Public Disclosure
IV. Environmental Impact
V. Objections and Hearing Requests
List of Subjects in 21 CFR Part 573
PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS
DATES:
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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:
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You may submit either electronic or written objections and a request for a hearing, identified byDocket No. FDA-2010-F-0537, by any of the following methods:
Electronic Submissions
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Submit electronic objections in the following way:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
Written Submissions
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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:
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Isabel W. Pocurull, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5877, isabel.pocurull@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
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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
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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.
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