[Federal Register Volume 77, Number 11 (Wednesday, January 18, 2012)]
[Proposed Rules]
[Pages 2492-2493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-797]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 172, 173, 178, and 180

[Docket No. FDA-2010-F-0320]


United States Pharmacopeial Convention; 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 the U.S. Pharmacopeial 
Convention requesting that the food additive regulations that 
incorporate by reference food-grade specifications from prior editions 
of the Food Chemicals Codex (FCC) be amended to incorporate by 
reference food-grade specifications from the FCC, 7th Edition.

DATES: Submit either electronic or written comments on the petitioner's 
environmental assessment by February 17, 2012.

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: Mical E. Honigfort, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, (240) 402-1278.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register on August 10, 2010 (75 FR 48353), FDA announced that a food 
additive petition (FAP 0A4782) had been filed by U.S. Pharmacopeial 
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852. The petition 
proposes that certain food additive regulations, which incorporate by 
reference food-grade specifications from prior editions of the FCC, be 
amended to incorporate by reference food-grade specifications from the 
FCC, 7th Edition.
    Under 21 CFR 171.1(c)(H), either a claim of categorical exclusion 
under Sec.  25.30 (21 CFR 25.30) or 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.  
25.30(i) was submitted with the petition, which applies to corrections 
and technical changes in regulations. The Agency reviewed the claim of 
categorical exclusion submitted by the petitioner and stated in the 
original filing notice its determination that, under Sec.  25.30(i), 
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 actions being requested in the petition are neither 
corrections nor technical changes, and, therefore, the categorical 
exclusion in Sec.  25.30(i) 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 regulation 
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

[[Page 2493]]

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: January 6, 2012.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 2012-797 Filed 1-17-12; 8:45 am]
BILLING CODE 4160-01-P