[Federal Register Volume 79, Number 218 (Wednesday, November 12, 2014)]
[Notices]
[Page 67174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26709]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-F-1539]


DSM Nutritional Products; Food Additive Petition (Animal Use); 
Ethoxyquin; Environmental Assessment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of an environmental assessment filed by DSM Nutritional 
Products in support of their petition proposing that the food additive 
regulations be amended to provide for the safe use of ethoxyquin in 
vitamin D formulations, including 25-hydroxyvitamin D<INF>3</INF>, used 
in animal food.

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, Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-453-6853.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 23, 2013 
(78 FR 77384) FDA published notice that a food additive petition (FAP) 
had been filed by DSM Nutritional Products, 45 Waterview Blvd., 
Parsippany, NJ 07054. The petition (FAP 2276) 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 of ethoxyquin as a chemical preservative in 
vitamin D formulations, including 25-hydroxyvitamin D<INF>3,</INF> used 
in animal food. In that document, FDA noted that the petitioner had 
requested a categorical exclusion from preparing an environmental 
assessment or environmental impact statement under 21 CFR 25.32(k).
    Upon further review and request by FDA, the petitioner has filed an 
environmental assessment. To encourage public participation consistent 
with regulations issued under the National Environmental Policy Act (40 
CFR 1501.4(b)), the Agency is placing the environmental assessment 
submitted with the petition that is the subject of this notice on 
public display at the Division of Dockets Management (see ADDRESSES) 
for public review and comment.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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. FDA will also place on public display any amendments 
to, or comments on, the petitioner's environmental assessment without 
further announcement in the Federal Register. If, based on its review, 
the Agency finds that an environmental impact statement is not required 
and this petition results in a regulation, the notice of availability 
of the Agency's finding of no significant impact and the evidence 
supporting that finding will be published with the regulation in the 
Federal Register in accordance with 21 CFR 25.51(b).

    Dated: November 6, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-26709 Filed 11-10-14; 8:45 am]
BILLING CODE 4164-01-P