
[Federal Register Volume 77, Number 56 (Thursday, March 22, 2012)]
[Proposed Rules]
[Page 16784]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6854]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2012-C-0224]


E. & J. Gallo Winery; Filing of Color 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 E. & 
J. Gallo Winery has filed a petition proposing that the color additive 
regulations be amended to provide for the expanded safe use of mica-
based pearlescent pigments as color additives in certain distilled 
spirits.

FOR FURTHER INFORMATION CONTACT: Raphael A. Davy, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1272.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (section 721(d)(1) (21 U.S.C. 379e(d)(1))), notice is given that a 
color additive petition (CAP 2C0294) has been filed by E. & J. Gallo 
Winery, c/o Keller and Heckman LLP, One Embarcadero Center, Suite 2110, 
San Francisco, CA 94111. The petition proposes to amend the color 
additive regulations in 21 CFR 73.350 to provide for the safe use of 
mica-based pearlescent pigments prepared from titanium dioxide and mica 
as color additives in distilled spirits containing not less than 18% 
and not more than 23% alcohol by volume but not including distilled 
spirits mixtures containing more that 5% wine on a proof gallon basis.
    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: March 13, 2012.
Francis Lin,
Acting Director, Office of Food Additive Safety, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 2012-6854 Filed 3-21-12; 8:45 am]
BILLING CODE 4160-01-P


