[Federal Register Volume 77, Number 114 (Wednesday, June 13, 2012)]
[Proposed Rules]
[Page 35317]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14263]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2012-F-0480]


Gruma Corporation, Spina Bifida Association, March of Dimes 
Foundation, American Academy of Pediatrics, Royal DSM N.V., and 
National Council of La Raza; Filing of Food Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that 
Gruma Corporation, Spina Bifida Association, March of Dimes Foundation, 
American Academy of Pediatrics, Royal DSM N.V., and National Council of 
La Raza have jointly filed a petition proposing that the food additive 
regulations be amended to provide for the safe use of folic acid in 
corn masa flour.

FOR FURTHER INFORMATION CONTACT: Judith Kidwell, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1071.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (sec. 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food 
additive petition (FAP 2A4796) has been jointly filed by Gruma 
Corporation, Spina Bifida Association, March of Dimes Foundation, 
American Academy of Pediatrics, Royal DSM N.V., and National Council of 
La Raza, c/o Alston & Bird, LLP, 950 F Street NW., Washington, DC 
20004-1404. The petition proposes to amend the food additive 
regulations in Sec.  172.345 Folic acid (folacin) (21 CFR 172.345) to 
provide for the safe use of folic acid in corn masa flour.
    The Agency has determined under 21 CFR 25.32(k) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

    Dated: June 7, 2012.
Dennis M. Keefe,
Acting Director, Office of Food Additive Safety, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 2012-14263 Filed 6-12-12; 8:45 am]
BILLING CODE 4160-01-P