[Federal Register Volume 76, Number 108 (Monday, June 6, 2011)]
[Proposed Rules]
[Pages 32332-32333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-13907]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2011-F-0365]


BASF Corp.; Filing of Food Additive Petition (Animal Use); Methyl 
Esters of Conjugated Linoleic Acid; Silicon Dioxide

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that BASF 
Corp. has filed a petition proposing that the food additive regulations 
be amended to provide for the safe use of methyl esters of conjugated 
linoleic acid (CLA) as a source of fatty acids in lactating dairy cow 
diets and for use of silicon dioxide as a carrier for the methyl esters 
of CLA.

DATES: Submit either electronic or written comments on the petitioner's 
environmental assessment by July 6, 2011.

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, [email protected].

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a 
food additive petition (FAP 2269) has been filed by BASF Corp. (BASF), 
100 Campus Dr., Florham Park, NJ 07932. The petition proposes to amend 
the food additive regulations in part 573 Food Additives Permitted in 
Feed and Drinking Water of Animals (21 CFR part 573) to provide for the 
safe use of methyl esters of conjugated linoleic acid (cis-9, trans-11 
and trans-10, cis-12 octadecadienoic acids) as a source of fatty acids 
in lactating dairy cow diets. BASF's FAP 2269 further proposes the use 
of silicon dioxide as a carrier for methyl esters of CLA.
    The potential environmental impact of this action is being 
reviewed. 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 DATES and ADDRESSES) for public 
review and comment.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. 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. 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).


[[Page 32333]]


    Dated: May 31, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-13907 Filed 6-3-11; 8:45 am]
BILLING CODE 4160-01-P