United States Pharmacopeial Convention; Filing of Food Additive Petition; Amendment, 2492-2493 [2012-797]

Download as PDF 2492 Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Proposed Rules defects will be 13 containers. As a result, additional containers will be required if the inspection for quality or U.S. grade calls for fewer than 13 containers. Table XIII of this section provides acceptance numbers for internal container defects for selected sample sizes. TABLE XII—INTERIOR CONTAINER DEFECTS Categories Defects Major De-tinning in metal container materially affecting usability ............................................................................................. De-tinning in metal container not materially affecting usability ....................................................................................... Black spots in metal container ........................................................................................................................................ Enamel missing (when required) in metal container ....................................................................................................... Enamel breakdown in metal container material affecting usability ................................................................................. Enamel cracked in metal container material not affecting usability ................................................................................ Interior of container damaged materially affecting usability ............................................................................................ Interior of container damaged not materially affecting usability ...................................................................................... Other anomaly (ies) of the interior of the container (metal, plastic, paper, rigid, etc.) that materially affects usability Other anomaly (ies) of the interior of the container (metal, plastic, paper, rigid, etc.) that materially affects appearance but not usability ................................................................................................................................................... TABLE XIII—ACCEPTANCE NUMBERS FOR INTERNAL CONTAINER DEFECTS Major Total Interior defects Sample size (n = number of containers) Interior defects Ac n—13 n—21 n—29 n—38 n—48 n—60 ................ ................ ................ ................ ................ ................ Re 0 1 1 2 2 2 Ac 1 2 2 3 3 3 Re 2 3 4 5 6 7 3 4 5 6 7 8 Dated: January 10, 2012. David R. Shipman, Acting Administrator, Agricultural Marketing Service. [FR Doc. 2012–833 Filed 1–17–12; 8:45 am] BILLING CODE 3410–02–P 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. srobinson on DSK4SPTVN1PROD with PROPOSALS ACTION: Notice of petition. 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 SUMMARY: VerDate Mar<15>2010 17:14 Jan 17, 2012 Jkt 226001 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 https:// 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 § 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 § 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 PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 Minor 101 .................... .................... 102 103 .................... 104 .................... 105 .................... 201 202 .................... .................... 203 .................... 204 .................... .................... 205 filing notice its determination that, under § 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 § 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 E:\FR\FM\18JAP1.SGM 18JAP1 Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Proposed Rules 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). To avoid duplication, please use only one of these four methods. See the ‘‘Public Participation and Request for Comments’’ portion of the SUPPLEMENTARY INFORMATION section below for instructions on submitting comments. Dated: January 6, 2012. Dennis M. Keefe, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. FOR FURTHER INFORMATION CONTACT: [FR Doc. 2012–797 Filed 1–17–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard If you have questions on this proposed rule, call or email Mr. Ronald Houck, U.S. Coast Guard Sector Baltimore, MD; telephone (410) 576–2674, email Ronald.L.Houck@uscg.mil. If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone (202) 366–9826. SUPPLEMENTARY INFORMATION: Public Participation and Request for Comments 33 CFR Part 100 AGENCY: We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted without change to https:// www.regulations.gov and will include any personal information you have provided. ACTION: Submitting Comments [Docket No. USCG–2011–1120] RIN 1625–AA08 Special Local Regulations for Marine Events; Spa Creek and Annapolis Harbor, Annapolis, MD Coast Guard, DHS. Notice of proposed rulemaking. The Coast Guard proposes to establish special local regulations during the swim segment of the ‘‘TriRock Triathlon Series’’, a marine event to be held on the waters of Spa Creek and Annapolis Harbor on May 12, 2012. These special local regulations are necessary to provide for the safety of life on navigable waters during the event. This action is intended to temporarily restrict vessel traffic in a portion of the Spa Creek and Annapolis Harbor during the event. DATES: Comments and related material must be received by the Coast Guard on or before February 17, 2012. Requests for public meetings must be received by the Coast Guard on or before the end of the comment period. ADDRESSES: You may submit comments identified by docket number USCG– 2011–1120 using any one of the following methods: (1) Federal eRulemaking Portal: https://www.regulations.gov. (2) Fax: (202) 493–2251. (3) Mail: Docket Management Facility (M–30), U.S. Department of Transportation, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590– 0001. (4) Hand delivery: Same as mail address above, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is (202) 366–9329. srobinson on DSK4SPTVN1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 17:14 Jan 17, 2012 Jkt 226001 If you submit a comment, please include the docket number for this rulemaking (USCG–2011–1120), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online (via https:// www.regulations.gov) or by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online via www.regulations.gov, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the Docket Management Facility. We recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission. To submit your comment online, go to https://www.regulations.gov, click on the ‘‘submit a comment’’ box, which will then become highlighted in blue. In the ‘‘Document Type’’ drop down menu select ‘‘Proposed Rule’’ and insert ‘‘USCG–2011–1120’’ in the ‘‘Keyword’’ box. Click ‘‘Search’’ then click on the balloon shape in the ‘‘Actions’’ column. If you submit your comments by mail or PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 2493 hand delivery, submit them in an unbound format, no larger than 81⁄2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period and may change the rule based on your comments. Viewing Comments and Documents To view comments, as well as documents mentioned in this preamble as being available in the docket, go to https://www.regulations.gov, click on the ‘‘read comments’’ box, which will then become highlighted in blue. In the ‘‘Keyword’’ box insert ‘‘USCG–2011– 1120’’ and click ‘‘Search.’’ Click the ‘‘Open Docket Folder’’ in the ‘‘Actions’’ column. You may also visit the Docket Management Facility in Room W12–140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. We have an agreement with the Department of Transportation to use the Docket Management Facility. Privacy Act Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316). Public Meeting We do not now plan to hold a public meeting. But you may submit a request for one on or before the end of the comment period, using one of the four methods specified under ADDRESSES. Please explain why you believe a public meeting would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the Federal Register. Basis and Purpose On Saturday, May 12, 2012, Competitor Group Inc. of San Diego, California, will sponsor the ‘‘TriRock Triathlon Series’’ in Annapolis, Maryland. The swim segment of the event will occur from 6:30 a.m. to 9:15 a.m. and will be located in Spa Creek and Annapolis Harbor. Up to 300 swimmers will operate on a 500-meter E:\FR\FM\18JAP1.SGM 18JAP1

Agencies

[Federal Register Volume 77, Number 11 (Wednesday, January 18, 2012)]
[Proposed Rules]
[Pages 2492-2493]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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 https://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

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