
[Federal Register Volume 77, Number 171 (Tuesday, September 4, 2012)]
[Proposed Rules]
[Pages 53801-53802]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-21639]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2011-F-0765]


Nexira; Filing of Food Additive Petition; Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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SUMMARY: The Food and Drug Administration (FDA) is amending the filing 
notice for a food additive petition filed by Nexira proposing that the 
food additive regulations be amended to provide for the expanded safe 
use of acacia gum (gum arabic) in foods.

DATES: Submit either electronic or written comments on the petitioner's 
environmental assessment by October 4, 2012.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-

[[Page 53802]]

305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ellen Anderson, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1309.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register on December 20, 2011 (76 FR 78866), FDA announced that a food 
additive petition (FAP 1A4784) had been filed by Nexira, c/o Keller and 
Heckman LLP, 1001 G St. NW., Suite 500 West, Washington, DC 20001. The 
petition proposes to amend the food additive regulations in Sec.  
172.780 Acacia (gum arabic) (21 CFR 172.780) to provide for the 
expanded safe use of acacia gum (gum arabic) in food.
    Under 21 CFR 171.1(c)(H), either a claim of categorical exclusion 
under 21 CFR 25.30 or Sec.  25.32 (21 CFR 25.32) or an environmental 
assessment under 21 CFR 25.40 is required to be submitted in a food 
additive petition. A claim of categorical exclusion under Sec.  
25.32(k) was submitted with the petition, which applies to substances 
added directly to food that are intended to remain in food through 
ingestion by consumers and that are not intended to replace 
macronutrients in food. The Agency reviewed the claim of categorical 
exclusion submitted by the petitioner and stated in the original filing 
notice its determination that, under Sec.  25.32(k), the proposed 
action was of a type that does not individually or cumulatively have a 
significant effect on the human environment, and therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    However, upon further review of the petition, the Agency has 
decided that the food additive may act to replace macronutrients in 
food and, therefore, the categorical exclusion in Sec.  25.32(k) is not 
applicable for the proposed action. The Agency informed the petitioner 
of this decision, who subsequently submitted an environmental 
assessment.
    The potential environmental impact of this petition 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. 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).

    Dated: August 28, 2012.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 2012-21639 Filed 8-31-12; 8:45 am]
BILLING CODE 4160-01-P


