2012-14263. 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  

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    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of petition.

    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.

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    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.

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    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 § 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.

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    Dated: June 7, 2012.

    Dennis M. Keefe,

    Acting Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition.

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    [FR Doc. 2012-14263 Filed 6-12-12; 8:45 am]

    BILLING CODE 4160-01-P

Document Information

Comments Received:
0 Comments
Published:
06/13/2012
Department:
Food and Drug Administration
Entry Type:
Proposed Rule
Action:
Notice of petition.
Document Number:
2012-14263
Pages:
35317-35317 (1 pages)
Docket Numbers:
Docket No. FDA-2012-F-0480
PDF File:
2012-14263.pdf
Supporting Documents:
» Reference 12 Memorandum from J. Zang, Toxicology Team, Division of Petition Review, to J. Kidwell, Division of Petition Review, March 23, 2016 re Food Additives Permitted for Direct Addition to Food for Human Consumption; Folic Acid
» Reference 24 The Availability of Food Folate in Man re Food Additives Permitted for Direct Addition to Food for Human Consumption; Folic Acid
» Reference 21 The extremely slow and variable activity of dihydrofolate reductase in human liver and its implications for high folic acid intake re Food Additives Permitted for Direct Addition to Food for Human Consumption; Folic Acid
» Reference 20 Cognitive impairment in older Americans in the age of folic acid fortification re Food Additives Permitted for Direct Addition to Food for Human Consumption; Folic Acid
» Reference 19 Vital and Health Statistics re Food Additives Permitted for Direct Addition to Food for Human Consumption; Folic Acid
» Reference 18 Vitamin B12 deficiency re Food Additives Permitted for Direct Addition to Food for Human Consumption; Folic Acid
» Reference 17 Vitamin B12 Deficiency re Food Additives Permitted for Direct Addition to Food for Human Consumption; Folic Acid
» Reference 16 Vitamin B12 Deficiency re Food Additives Permitted for Direct Addition to Food for Human Consumption; Folic Acid
» Reference 15 The Prevalence of Low Serum Vitamin B-12 Status in the Absence of Anemia or Macrocytosis Did Not Increase among Older U.S. Adults after Mandatory Folic Acid Fortification re Food Additives Permitted for Direct Addition to Food for Human Cons
» Reference 13 Memorandum from H. Lee, Chemistry Review Group, Division of Petition Review, to J. Kidwell, Regulatory Group I, Division of Petition Review, April 2, 2014 re Food Additives Permitted for Direct Addition to Food for Human Consumption; Folic A
CFR: (1)
21 CFR 172