Unknown. Final rule
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/register/2011/03/14/2011-5716A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
--- schema: federal-register doc_type: fedreg source_file: FR-2011-03-14.xml --- 76 49 Monday, March 14, 2011 Contents Agricultural Marketing Agricultural Marketing Service RULES National Organic Program: Amendment to National List of Allowed and Prohibited Substances, 13501-13504 2011-5716 PROPOSED RULES Amendment of Marketing Agreement and Order No.930: Tart Cherries Grown in Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin, 13528-13530 2011-5717 Mango Promotion, Research, and Information Order;
Reapportionment, 13530-13532 2011-5715 Agriculture Agriculture Department See Agricultural Marketing Service See Animal and Plant Health Inspection Service See Farm Service Agency See Foreign Agricultural Service See Forest Service See Rural Utilities Service Animal Animal and Plant Health Inspection Service NOTICES Environmental Assessments; Availability, etc.: Biological Control Agent for Hawkweeds, 13597 2011-5714 Arts and Humanities, National Foundation See National Foundation on the Arts and the Humanities Centers Disease Centers for Disease Control and Prevention NOTICES Meetings:
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel, 13621 2011-5755 2011-5759 Disease, Disability, and Injury Prevention and Control Special Emphasis Panel, Funding Opportunity, 13619-13620 2011-5632 National Institute for Occupational Safety and Health, Opportunity for Businesses to Partner, etc., 13620-13623 2011-5732 2011-5733 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicare Program: Reductions and Increases to Hospitals' FTE Resident Caps for Graduate Medical Education Payment Purposes, 13515-13524 2011-5960 Coast Guard Coast Guard RULES Ninth Coast Guard District Sector Realignment:
Northern Lake Michigan and Lake Huron, 13508-13511 2011-5731 Commerce Commerce Department See Foreign-Trade Zones Board See International Trade Administration See National Oceanic and Atmospheric Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 13601-13602 2011-5793 Employment and Training Employment and Training Administration NOTICES Amended Certification Regarding Eligibility to Apply for Worker Adjustment Assistance: Arcelor Mittal, Ferndale, MI, 13665 2011-5648 Cambridge Tool & Die, Cambridge, OH, 13665-13666 2011-5659 Celestica, et al.
Arden Hills, MN, 13663-13664 2011-5650 Chrysler Group Llc, et al., Kenosha, WI, 13667 2011-5652 Cinram Manufacturing, Llc, Olyphant, PA, 13668 2011-5647 Commercial Furniture Group, Inc., Morristown, TN and Chicago, IL, 13667 2011-5654 Cooper Tools, Hicksville, OH, 13663 2011-5653 Eaton Corp., Clutch Division, Auburn, IN, 13663 2011-5660 Elkay Manufacturing, Broadview, Illinois, 13664-13665 2011-5649 General Motors Corp., et al., Flint, MI, 13666-13667 2011-5655 Hewlett Packard Co., Roseville, CA, 13662-13663 2011-5658 Mega Life & Health Ins.
Co., et al., North Richland, TX, 13665 2011-5661 Pass & Seymour/Legrand, Concord, NC, 13662 2011-5656 Pitney Bowes, Inc., Shelton, CT, 13666 2011-5657 Visteon Corp. et al., Van Buren Township, MI, 13664 2011-5651 Energy Department Energy Department See Federal Energy Regulatory Commission NOTICES Evaluations; Availability, etc.: Waste Incidental to Reprocessing for the Vitrification Melter at the West Valley Demonstration Project for West Valley, NY, 13605-13606 2011-5789 Meetings:
Ultra-Deepwater Advisory Committee, 13606-13607 2011-5806 Quadrennial Technology Review Framing Document; Availability, 13607-13608 2011-5794 Environmental Protection Environmental Protection Agency RULES Approvals and Promulgations of Air Quality Implementation Plans: Virginia; Revisions to Open Burning Regulations, 13511-13514 2011-5625 National Emission Standards for Hazardous Air Pollutants for Chemical Manufacturing Area Sources, 13514-13515 2011-5778 PROPOSED RULES Approval and Promulgation of Air Quality Implementation Plans:
Pennsylvania; Adoption of Control Techniques Guidelines for Flat Wood Paneling Surface Coating Processes, 13567-13569 2011-5796 Virginia; Revisions to Open Burning Regulations, 13569 2011-5621 National Emission Standards for Hazardous Air Pollutants: Mercury Emissions from Mercury Cell Chlor-Alkali Plants, 13852-13878 2011-5530 NOTICES Meetings: Children's Health Protection Advisory Committee, 13615 2011-5803 Settlements: B and B Manufacturing Site, Mobile, Mobile County, AL, 13615-13616 2011-5837 Grants Chlorinated Solvents Superfund Site, Grants, Cibola County, NM, 13615 2011-5835 Picayune Wood Treating Site, Picayune, Pearl River County, MS, 13616 2011-5836 Farm Service Farm Service Agency NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: County Committee Elections, 13597-13598 2011-5770 Federal Aviation Federal Aviation Administration RULES Amendment of Class E Airspace: La Porte, IN; Correction, 13505-13506 2011-5744 PROPOSED RULES Airworthiness Directives: Boeing Co. Model 757-200, -200CB, and -300 Series Airplanes, 13541-13543 2011-5724 Boeing Co. Model 767-200, -300, -300F, and 400ER Series Airplanes, 13534-13536 2011-5721 Boeing Co. Model DC 9 81 (MD 81), DC 9 82 (MD 82), DC 9 83 (MD 83), DC 9 87 (MD 87), and MD-88 Airplanes, 13543-13546 2011-5725 Boeing Co.
Model MD-90-30 Airplanes, 13546-13549 2011-5726 Bombardier, Inc. Model CL 600 2C10, Model CL 600 2D15 and Model CL 600 2D24 Airplanes, 13536-13539 2011-5722 Empresa Brasileira de Aeronautica S.A. (EMBRAER) Model ERJ 190 Airplanes, 13539-13541 2011-5723 Federal Communications Federal Communications Commission RULES Radio Broadcasting Services: Willow Creek, CA, 13524-13525 2011-5089 PROPOSED RULES Implementing the Provisions of the Twenty-First Century Communications and Video Accessibility Act of 2010, 13800-13849 2011-5348 Jurisdictional Separations and Referral to the Federal-State Joint Board, 13576-13579 2011-5817 Radio Broadcasting Services:
Hebbronville, TX, 13579 2011-5814 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 13616-13617 2011-5740 Federal Emergency Federal Emergency Management Agency PROPOSED RULES Flood Elevation Determinations; Correction, 13569-13572 2011-5818 2011-5819 2011-5834 Flood Elevation Determinations, 13572-13576 2011-5828 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Property Acquisition and Relocation for Open Space, 13651-13652 2011-5827 Severe Repetitive Loss Appeals, 13652-13653 2011-5825 Major Disaster and Related Determinations:
Connecticut, 13653-13654 2011-5820 Massachusetts, 13654-13655 2011-5824 Major Disaster Declarations: New York; Amendment No. 1, 13655 2011-5823 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 13608-13610 2011-5752 Compliance Filings: Enterprise Texas Pipeline LLC, 13610 2011-5782 Effectiveness of Exempt Wholesale Generator Status, 13610-13611 2011-5709 Filings: Bay Gas Storage, LLC, 13611 2011-5780 Enogex LLC, 13611 2011-5783 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorization:
Coolidge Power LLC, 13611-13612 2011-5751 Request for Jurisdictional Determination or Temporary Waiver of Tariff Filing and Reporting Requirements: Tesoro Refining and Marketing Co., and Tesoro Logistics Operations, LLC, 13612 2011-5707 Requests Under Blanket Authorizations: Freebird Gas Storage, LLC, 13612-13613 2011-5784 Staff Attendances: ICT Stakeholders Policy Committee and Entergy Regional State Committee, 13613 2011-5710 Technical Conference, 13613-13615 2011-5708 2011-5781 Federal Trade Federal Trade Commission PROPOSED RULES Fur Products Labeling Act, 13550-13553 2011-5757 Federal Transit Federal Transit Administration PROPOSED RULES Bus Testing:
Calculation of Average Passenger Weight and Test Vehicle Weight, 13580-13583 2011-5831 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 13698 2011-5830 Food and Drug Food and Drug Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Comparing Nutrition Knowledge, Attitude, and Behavior Among English-Dominant Hispanics, Spanish-Dominant Hispanics, and Other Consumers, 13626-13629 2011-5736 Medical Device Labeling Regulations, 13623-13626 2011-5739 Medical Devices;
Third Party Review Program under Food and Drug Administration Modernization Act, 13623 2011-5738 Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Information; Availability: Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use, 13629 2011-5816 Draft Guidance for Industry; Availability: User Fee Waivers, Reductions, and Refunds for Drug and Biological Products, 13629-13631 2011-5737 Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List Number 026, 13631-13638 2011-5815 Meetings: Ensuring the Safety of Imported Foods and Animal Feed; Comparability of Food Safety Systems and Import Practices of Foreign Countries, 13638-13642 2011-5943 FDA Food Safety Modernization Act; Title III - A New Paradigm for Importers, 13643-13645 2011-5942 Town Hall Discussion With Director of Center for Devices and Radiological Health and Other Senior Center Management, 13642-13643 2011-5735 Vaccines and Related Biological Products Advisory Committee, 13646 2011-5727 Foreign Agricultural Foreign Agricultural Service NOTICES Funding Availability:
McGovern-Dole International Food for Education and Child Nutrition Programs Micronutrient-Fortified Food Aid Products Pilot, 13598-13600 2011-5712 Foreign Trade Foreign-Trade Zones Board NOTICES Application for Subzone: Cabelas Inc.; Foreign-Trade Zone 59, Lincoln, NB, 13602 2011-5693 Forest Forest Service NOTICES Environmental Impact Statements; Availability, etc.: Golden Hand #3 and #4 Lode Mining Claims, Payette National Forest, ID; Withdrawal, 13600 2011-5760 Meetings: Shasta County Resource Advisory Commitee, 13601 2011-5298 West Virginia Resource Advisory Committee, 13601 2011-5768 White Pine-Nye County Resource Advisory Committee, 13600-13601 2011-5766 General Services General Services Administration NOTICES GSA Bulletin:
Office of Federal High-Performance Green Buildings, 13617 2011-5812 Geological Geological Survey NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 13658-13659 2011-5754 Government Printing Government Printing Office NOTICES Meetings: Depository Library Council to the Public Printer, 13617-13618 2011-5832 Health and Human Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Food and Drug Administration See Health Resources and Services Administration See National Institutes of Health PROPOSED RULES Application, Review, and Reporting Process for Waivers for State Innovation, 13553-13567 2011-5583 NOTICES Delegation of Authority;
Centers for Medicare and Medicaid Services, 13618-13619 2011-5779 Health Resources Health Resources and Services Administration NOTICES Statement of Delegation of Authority, 13646-13647 2011-5808 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency See U.S. Customs and Border Protection PROPOSED RULES Reducing Regulatory Burden; Retrospective Review under Executive Order 13563, 13526-13528 2011-5829 Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Compliance Inspection Report - Mortgagees Assurance of Completion, 13657-13658 2011-5807 Economic Opportunities for Low and Very Low Income Persons, 13656 2011-5811 Requirement for Contractors to Provide Certificates of Insurance for Capital Program Projects, 13656-13657 2011-5804 Technical Suitability of Products Program, 13658 2011-5805 Interior Interior Department See Geological Survey See Land Management Bureau International Trade Adm International Trade Administration NOTICES Continuation of Antidumping Duty Order:
Porcelain-on-Steel Cooking Ware from the People's Republic of China, 13602-13603 2011-5822 International Trade Com International Trade Commission NOTICES Investigations: Polyvinyl Alcohol from Taiwan, 13660 2011-5840 Terminations of Investigations: Certain Connecting Devices (Quick Clamps) for Use with Modular Compressed Air Conditioning Units, Including Filters, Regulators, etc., 13661 2011-5841 Justice Department Justice Department See Parole Commission Labor Department Labor Department See Employment and Training Administration See Occupational Safety and Health Administration See Workers Compensation Programs Office Land Land Management Bureau NOTICES Filing of Plats of Survey, Wyoming and Nebraska, 13659-13660 2011-5769 Meetings:
Alaska Resource Advisory Council, 13660 2011-5767 Maritime Maritime Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 13699-13700 2011-5747 2011-5748 Requested Administrative Waivers of Coastwise Trade Laws, 13700-13702 2011-5741 2011-5742 2011-5743 2011-5745 2011-5746 Mississippi Mississippi River Commission NOTICES Meetings; Sunshine Act, 13670-13671 2011-5956 National Archives National Archives and Records Administration NOTICES Privacy Act;
Systems of Records, 13671-13672 2011-5986 National Credit National Credit Union Administration RULES Conversions of Insured Credit Unions, 13504-13505 2011-5675 NOTICES Meetings; Sunshine Act, 13672 2011-5984 National Foundation National Foundation on the Arts and the Humanities NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 13672-13674 2011-5701 2011-5705 National Institute National Institutes of Health NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Interactive Diet and Activity Tracking in AARP; Biomarker Based Validation Study, 13647-13648 2011-5800 Process Evaluation of the NIH Roadmap Epigenomics Program, 13648-13649 2011-5786 Meetings: Eunice Kennedy Shriver National Institute of Child Health and Human Development, 13649-13651 2011-5788 2011-5790 2011-5795 2011-5797 National Institute of Allergy and Infectious Diseases, 13649 2011-5798 National Institute of Arthritis and Musculoskeletal and Skin Diseases, 13649-13650 2011-5792 National Institute of Environmental Health Sciences, 13650 2011-5791 National Oceanic National Oceanic and Atmospheric Administration PROPOSED RULES Atlantic Highly Migratory Species:
Atlantic Bluefin Tuna Quotas and Atlantic Tuna Fisheries Management Measures, 13583-13592 2011-5858 Fisheries of Exclusive Economic Zone Off Alaska: Bering Sea and Aleutian Islands Crab Rationalization Program; Amendment 34, 13593-13596 2011-5854 Fisheries Off West Coast States: Highly Migratory Species Fisheries; Amendment 2, 13592-13593 2011-5868 Reducing Regulatory Burden; Retrospective Review under E.O. 13563, 13549-13550 2011-5681 NOTICES Applications: Marine Mammals, File No. 16087, 13603-13604 2011-5838 Marine Mammals;
File No. 15748, 13603 2011-5852 Meetings: Western Pacific Fishery Management Council, 13604-13605 2011-5697 Permits: Marine Mammals; File No. 15616, 13605 2011-5849 National Science National Science Foundation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 13674-13675 2011-5801 Committee Management, Establishments: U.S. Antarctic Program Blue Ribbon Panel, 13675 2011-5734 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Withdrawal of Application for Amendment to Facility Operating License;
Correction: Exelon Generation Company, LLC, 13676 2011-5756 Occupational Safety Health Adm Occupational Safety and Health Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Respiratory Protection Standard, 13668-13669 2011-5668 Pacific Pacific Northwest Electric Power and Conservation Planning Council NOTICES Amended Columbia River Basin Fish and Wildlife Program, 13676 2011-5758 Parole Parole Commission NOTICES Record of Vote of Meeting Closure, 13661-13662 2011-5590 Postal Service Postal Service PROPOSED RULES New Origin Entry Separation and Containerization Standards, 13704-13767 2011-5273 Rural Utilities Rural Utilities Service RULES Rural Broadband Access Loans and Loan Guarantees Program, 13770-13796 2011-5615 NOTICES Rural Broadband Access Loans and Loan Guarantees Program, 13797 2011-5611 Securities Securities and Exchange Commission NOTICES Self-Regulatory Organizations;
Proposed Rule Changes: BATS Y-Exchange, Inc., 13681-13683 2011-5774 C2 Options Exchange, Inc., 13688-13689, 13691-13692 2011-5720 2011-5762 Chicago Board Options Exchange, Inc., 13690-13694 2011-5719 2011-5761 Fixed Income Clearing Corp., 13683-13684 2011-5773 NASDAQ OMX BX, Inc., 13676-13678 2011-5776 NASDAQ OMX PHLX LLC, 13678-13681, 13684-13686 2011-5764 2011-5775 NASDAQ Stock Market LLC, 13686-13688, 13694-13696 2011-5718 2011-5763 Suspension of Trading Orders: Admiralty Holding Co., et al., 13696-13697 2011-5934 Small Business Small Business Administration PROPOSED RULES Reducing Regulatory Burden;
Retrospective Review under Executive Order 13563, 13532-13534 2011-5839 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 13697 2011-5844 Disaster Declarations: Massachusetts, 13697-13698 2011-5842 New York; Amendment 1, 13698 2011-5843 Social Social Security Administration RULES Protecting the Public and Our Employees in Our Hearing Process, 13506-13508 2011-5750 Transportation Department Transportation Department See Federal Aviation Administration See Federal Transit Administration See Maritime Administration Treasury Treasury Department PROPOSED RULES Application, Review, and Reporting Process for Waivers for State Innovation, 13553-13567 2011-5583 Customs U.S.
Customs and Border Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Ships Store Declaration, 13655-13656 2011-5713 Workers' Workers Compensation Programs Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Division of Coal Mine Workers' Compensation, 13669-13670 2011-5826 Separate Parts In This Issue Part II Postal Service, 13704-13767 2011-5273 Part III Agriculture Department, Rural Utilities Service, 13770-13797 2011-5615 2011-5611 Part IV Federal Communications Commission, 13800-13849 2011-5348 Part V Environmental Protection Agency, 13852-13878 2011-5530 Reader Aids Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 76 49 Monday, March 14, 2011 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 [Document Number AMS-NOP-10-0051; NOP-10-04FR] RIN 0581-AD04 National Organic Program; Amendment to the National List of Allowed and Prohibited Substances (Livestock) AGENCY:
Agricultural Marketing Service, USDA. ACTION: Final rule. SUMMARY: The U.S. Department of Agriculture
(USDA)is adopting as final, without change, an interim rule published in the **Federal Register** on August 24, 2010 (75 FR 51919). The interim rule amended the National List of Allowed and Prohibited Substances (National List) based upon a recommendation submitted to the Secretary of Agriculture (Secretary) by the National Organic Standards Board
(NOSB)on April 29, 2010. Consistent with the recommendation from the NOSB, the interim rule revised the annotation of one substance on the National List, methionine, to extend its use in organic poultry production until October 1, 2012, at the following maximum levels of synthetic methionine per ton of feed: laying chickens—4 pounds; broiler chickens—5 pounds; turkeys and all other poultry—6 pounds. DATES: *Effective Date:* This rule becomes effective March 15, 2011. FOR FURTHER INFORMATION CONTACT: Melissa Bailey, Ph.D., Director, Standards Division, National Organic Program, USDA-AMS-NOP, 1400 Independence Ave., SW., Room 2646-So., Ag Stop 0268, Washington, DC 20250, *E-mail:* *Melissa.bailey@ams.usda.gov;* *Telephone:*
(202)720-3252; *Fax:*
(202)205-7808. SUPPLEMENTARY INFORMATION: I. Background On December 21, 2000, the Secretary established within the NOP [7 CFR part 205] the National List regulations §§ 205.600 through 205.607. The National List identifies synthetic substances that may be used and the nonsynthetic (natural) substances that may not be used in organic production. The National List also identifies nonagricultural nonsynthetic, nonagricultural synthetic, and nonorganic agricultural substances that may be used in organic handling. The Organic Foods Production Act of 1990 (OFPA), as amended (7 U.S.C. 6501-6522), and NOP regulations, in § 205.105, specifically prohibit the use of any synthetic substance for organic production and handling unless included on the National List. Section 205.105 also requires that any nonorganic agricultural, and any nonsynthetic, nonagricultural substance used in organic handling must also be on the National List. Under the authority of the OFPA, the National List can be amended by the Secretary based on proposed amendments developed by the NOSB. Since established, the NOP has published fourteen amendments to the National List: October 31, 2003 (68 FR 61987); November 3, 2003(68 FR 62215); October 21, 2005 (70 FR 61217); June 7, 2006 (71 FR 32803); September 11, 2006 (71 FR 53299); June 27, 2007 (72 FR 35137); October 16, 2007 (72 FR 58469); December 10, 2007 (72 FR 69569); December 12, 2007 (72 FR 70479); September 18, 2008 (73 FR 54057); October 9, 2008 (73 FR 59479); July 6, 2010 (75 FR 38693); August 24, 2010 (75 FR 51919); and December 13, 2010 (75 FR 77521). Additionally, proposed amendments to the National List were published on November 8, 2010 (75 FR 68505). As a result of a petition requesting to add synthetic methionine to the National List, the NOSB initiated a review of this substance in 1999. Methionine is classified as an essential amino acid because it cannot be biologically produced by poultry and is necessary to maintain viability. The petitioners asserted that methionine was a necessary dietary supplement for organic poultry and that there was an inadequate supply of allowable organic feeds containing sufficient concentrations of naturally occurring methionine. In 2001, the NOSB evaluated a technical advisory panel analysis of methionine against the criteria provided in the OFPA (7 U.S.C. 6517-6518), and determined that the use of synthetic methionine feed supplementation is compatible with a system of organic poultry production. Consistent with the NOSB's recommendation, the Secretary amended the National List to allow methionine as a synthetic substance for use in organic poultry production at § 205.603 of the NOP regulations beginning on October 31, 2003, with an expiration date of October 21, 2005 (68 FR 61987). Based upon additional NOSB recommendations submitted in March 2005 and May 2008, the Secretary subsequently amended the listing for methionine on the National List by extending its allowance in organic poultry production through October 21, 2008 (70 FR 61217), and again through October 1, 2010 (73 FR 54057). On July 31, 2009, a coalition of producers identified as the Methionine Task Force
(MTF)filed a petition that requested a five-year extension on the allowance for synthetic methionine. The MTF proposed to limit the total amount of synthetic methionine to be fed over the life of the bird calculated as the average pounds of synthetic methionine per ton of feed. The MTF proposed these limits per ton of feed as follows: 4 pounds for laying chickens, 5 pounds for broiler chickens, and 6 pounds for turkeys and all other poultry. Based upon their deliberations and the public comment received, the NOSB concluded that wholly natural sources of methionine are not currently available and that extending the allowance for the synthetic form of methionine was warranted. However, the NOSB did not accept the request to extend its allowance on the National List for five years at the limitations proposed by the petitioners because the NOSB felt that averaging the pounds of synthetic methionine fed over the life of the bird could result in higher levels of the substance being fed during certain growth stages. As a result, the NOSB opted to modify the annotation proposed by the petitioner by removing the language that would have allowed averaging the maximum level of methionine over the life of the bird and adding different limits on the feed allowance over time. On April 29, 2010, the NOSB issued a recommendation to extend the allowance for synthetic methionine for five years until October 1, 2015, with a step down in the amount allowed after two years. Specifically, the NOSB recommended that the amount of synthetic methionine allowed per ton of feed be limited to 4 pounds for laying chickens, 5 pounds for broiler chickens, and 6 pounds for turkeys and all other poultry until October 1, 2012. The NOSB further recommended that, after October 1, 2012, the allowance be reduced to 2 pounds for laying chickens, 2 pounds for broiler chickens, and 3 pounds for turkeys and all other poultry through October 1, 2015. On August 24, 2010, the Secretary amended the National List through publication of an interim rule with request for comments in the **Federal Register** to reflect the first part of the NOSB's recommendation (75 FR 51919). This action extended the allowance for synthetic methionine through October 1, 2012, at the levels specified by the NOSB. In the interim rule, the USDA agreed to publish a final rule on the listing of methionine, along with any changes if warranted, by March 2011. Based upon the NOSB recommendation and comments received, this final rule adopts, without change, the interim rule published on August 24, 2010 (75 FR 51919). Accordingly, this final rule continues the exemption at § 205.603(d)(1) for methionine as follows: DL-Methionine, DL- Methionine-hydroxy analog, and DL-Methionine-hydroxy analog calcium (CAS # 59-51-8; 63-68-3; 348-67-4)—for use only in organic poultry production until October 1, 2012, at the following maximum levels of synthetic methionine per ton of feed: Laying chickens—4 pounds; broiler chickens—5 pounds; turkeys and all other poultry—6 pounds. II. Related Documents Since September 2001, four notices have been published announcing meetings of the NOSB and its planned deliberations on recommendations involving the use of methionine in organic poultry production. The four notices were published in the **Federal Register** as follows: September 21, 2001 (66 FR 48654), February 11, 2005 (70 FR 7224), April 4, 2008 (73 FR 18491), and March 17, 2010 (75 FR 12723). Methionine was first proposed for addition to the National List in the **Federal Register** on April 16, 2003 (68 FR 18556). Methionine was added to the National List by final rule in the **Federal Register** on October 31, 2003 (68 FR 61987). A proposal to amend the annotation for methionine was published in the **Federal Register** on July 29, 2005 (70 FR 43786), and the annotation was amended by final rule in the **Federal Register** on October 21, 2005 (70 FR 61217). A proposal to amend the annotation once again was published in the **Federal Register** on July 14, 2008 (73 FR 40197), and the annotation was amended by final rule on September 18, 2008 (73 FR 54057). The annotation for methionine was most recently amended through publication of an interim rule with request for comments in the **Federal Register** on August 24, 2010 (75 FR 51919). III. Statutory and Regulatory Authority The OFPA, as amended (7 U.S.C. 6501-6522), authorizes the Secretary to make amendments to the National List based on proposed amendments developed by the NOSB. Sections 6518(k)(2) and 6518(n) of the OFPA authorize the NOSB to develop proposed amendments to the National List for submission to the Secretary and establish a petition process by which persons may petition the NOSB for the purpose of having substances evaluated for inclusion or deletion from the National List. The National List petition process is implemented under § 205.607 of the NOP regulations. The current petition process (72 FR 2167, January 18, 2007) can be accessed through the NOP Web site at *http://www.ams.usda.gov/nop.* A. Executive Order 12866 This action has been determined not significant for purposes of Executive Order 12866, and therefore, has not been reviewed by the Office of Management and Budget. B. Executive Order 12988 Executive Order 12988 instructs each executive agency to adhere to certain requirements in the development of new and revised regulations in order to avoid unduly burdening the court system. The final rule (68 FR 61987), dated October 31, 2003, adding methionine to the National List was reviewed under this Executive Order and no additional information related to Executive Order 12988 has been obtained since then. This final rule is not intended to have a retroactive effect. States and local jurisdictions are preempted under the OFPA from creating programs of accreditation for private persons or State officials who want to become certifying agents of organic farms or handling operations. A governing State official would have to apply to USDA to be accredited as a certifying agent, as described in § 2115(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under §§ 2104 through 2108 of the OFPA (7 U.S.C. 6503 through 6507) from creating certification programs to certify organic farms or handling operations unless the State programs have been submitted to, and approved by, the Secretary as meeting the requirements of the OFPA. Pursuant to § 2108(b)(2) of the OFPA (7 U.S.C. 6507(b)(2)), a State organic certification program may contain additional requirements for the production and handling of organically produced agricultural products that are produced in the State and for the certification of organic farm and handling operations located within the State under certain circumstances. Such additional requirements must:
(a)Further the purposes of the OFPA,
(b)not be inconsistent with the OFPA,
(c)not be discriminatory toward agricultural commodities organically produced in other States, and
(d)not be effective until approved by the Secretary. Pursuant to § 2120(f) of the OFPA (7 U.S.C. 6519(f)), this final rule would not alter the authority of the Secretary under the Federal Meat Inspection Act (21 U.S.C. 601 *et seq.* ), the Poultry Products Inspections Act (21 U.S.C. 451 *et seq.* ), or the Egg Products Inspection Act (21 U.S.C. 1031 *et seq.* ), concerning meat, poultry, and egg products, nor any of the authorities of the Secretary of Health and Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 *et seq.* ), nor the authority of the Administrator of the Environmental Protection Agency under the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 *et seq.* ). Section 2121 of the OFPA (7 U.S.C. 6520) provides for the Secretary to establish an expedited administrative appeals procedure under which persons may appeal an action of the Secretary, the applicable governing State official, or a certifying agent under this title that adversely affects such person or is inconsistent with the organic certification program established under this title. The OFPA also provides that the U.S. District Court for the district in which a person is located has jurisdiction to review the Secretary's decision. C. Regulatory Flexibility Act The Regulatory Flexibility Act
(RFA)(5 U.S.C. 601-612) requires agencies to consider the economic impact of each rule on small entities and evaluate alternatives that would accomplish the objectives of the rule without unduly burdening small entities or erecting barriers that would restrict their ability to compete in the market. The purpose is to fit regulatory actions to the scale of businesses subject to the action. Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities. Pursuant to the requirements set forth in the RFA, AMS performed an economic impact analysis on small entities in the final rule published in the **Federal Register** on December 21, 2000 (65 FR 80548). AMS has also considered the economic impact of this action on small entities. The impact on entities affected by this final rule would not be significant. The current approval for the use of synthetic methionine in organic poultry production was extended in the interim rule through October 1, 2012, at levels that are consistent with current industry practice. The effect of this final rule is to affirm the continued use of synthetic methionine as amended. AMS concludes that this action would have minimal economic impact on small agricultural service firms. Accordingly, USDA certifies that this rule will not have a significant economic impact on a substantial number of small entities. Small agricultural service firms, handlers, and accredited certifying agents, have been defined by the Small Business Administration
(SBA)(13 CFR 121.201) as those having annual receipts of less than $7,000,000, and small agricultural producers are defined as those having annual receipts of less than $750,000. Based on USDA data from the Economic Research Service (ERS), the U.S. organic sector included nearly 13,000 certified organic crop and livestock operations at the end of 2008. These operations contained more than 4.8 million certified acres consisting of 2,665,382 acres of cropland and 2,160,577 acres of pasture and rangeland. The total acreage under organic management represents a twelve percent increase from 2007. Organic poultry production has steadily contributed to the overall growth in the organic food market. ERS estimated that there were 5,538,011 laying chickens and 9,015,984 broiler chickens raised under organic management in 2008. ERS estimated the number of certified organic turkeys raised in the United States in 2008 at 398,531. 1 The Nutrition Business Journal calculated the market value for organic laying chickens at $252,000,000 in 2008. 2 In addition to being sold as whole products, organic eggs and poultry byproducts are used in the production of organic processed products including soups, broths, prepared meals, ice cream and eggnog. 1 U.S. Department of Agriculture, Economic Research Service, 2009. Data Sets: *U.S. Certified Organic Farmland Acreage, Livestock Numbers and Farm Operations, 1992-2008. http://www.ers.usda.gov/Data/Organic/.* 2 *Nutrition Business Journal, 2009. U.S. Organic Food Sales by Product ($Mil) 1997-2008, 2009(e)-2014(e)—Chart 22.* Penton Media, Inc. The USDA accredits certifying agents who provide organic certification services to producers and handlers. A complete list of names and addresses of accredited certifying agents may be found on the AMS NOP Web site, at *http://www.ams.usda.gov/nop.* AMS believes that most of these entities would be considered small entities under the criteria established by the SBA. D. Paperwork Reduction Act No additional collection or recordkeeping requirements are imposed on the public by this final rule. Accordingly, OMB clearance is not required by section 350(h) of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 *et seq.* or OMB's implementing regulations at 5 CFR part 1320. The AMS is committed to compliance with the E-Government Act, to promote the use of the Internet and other information technologies increased opportunities for citizen access to Government information and services, and for other purposes. E. Discussion of Comments Received AMS received 8 comments on the interim rule that extended the use of synthetic methionine in organic poultry production until October 1, 2012, at the following maximum levels of synthetic methionine per ton of feed: laying chickens—4 pounds; broiler chickens—5 pounds; turkeys and all other poultry—6 pounds. Comments were received from two organic livestock producers including one representing multiple individuals, two trade associations, two non-profit advocacy groups and two private individuals. Some comments endorsed the amendment that extended the allowance for synthetic methionine. These commenters asserted that continuing the allowance was critical to the organic poultry industry, citing methionine as a nutrient necessary for proper feather development and cell growth. These comments further voiced that, while research continues on meeting the nutritional requirements of poultry through natural sources of methionine, the limited commercial availability of feed containing natural sources of methionine supports the need for continuing the allowance of synthetic forms of the substance on the National List. One comment strongly advocated for future inclusion of synthetic methionine on the National List for a five-year sunset review cycle after the October 1, 2015, expiration of the current petition-based NOSB recommendation. The interim rule for which we requested comments does not address the listing of methionine beyond its current expiration date of October 1, 2012. We plan to address the allowance for synthetic methionine after this date through a separate rulemaking action. Changes Requested But Not Made Two comments in favor of extending the use of methionine did not believe the limitations for use in different types of poultry as specified in the interim rule are necessary. One of these comments indicated concern that limiting the use of methionine to certain levels may impact the management practices of poultry producers by reducing the flexibility of producers to balance poultry rations with changing environmental conditions. However, based upon additional statements provided in this comment and testimony provided during NOSB deliberations, we believe that maximum levels in the interim rule are consistent with current industry practice and, therefore, will be feasible for most producers without major changes to their current management approach. The other comment related to limiting the allowable levels of methionine in specific groups of poultry recommended relisting methionine without annotation. The rationale provided by the comment is that the future “step down” proposed by the NOSB has the potential for increased recordkeeping by the producer and the certification agency. Because the action in the interim rule did not address the “step down” portion of the NOSB recommendation, this rationale does not apply to the current amendment and, therefore, we do not believe a change to the annotation as codified in the interim rule is warranted. A few comments rejected the provisions in the amendment and argued in favor of an immediate prohibition on the use of synthetic methionine in organic poultry production. One comment did not express an opinion pertinent to the specifics of the amendment. The few comments opposing the extension of the allowance for synthetic methionine stated that use of the substance was incompatible with the regulatory definition of “organic production.” Another comment objecting to extending the allowance questioned whether OFPA sanctions the use of a synthetic amino acid. This comment also cited natural alternatives to synthetic methionine and suggested that the continued allowance of synthetic methionine continues to delay the commercial development of alternatives to the synthetic form. In developing their recommendation on the continued allowance for synthetic methionine on the National List, the NOSB reviewed the substance against the evaluation criteria of 7 U.S.C. 6517 and 6518 of the OFPA. The NOSB recommended that, after October 1, 2012, the annotation for methionine be amended to reduce the maximum amount of the substance allowed and establish October 1, 2015, as the expiration date. The NOSB's intent is that a step down in the levels allowed after October 1, 2012, will stimulate further market development of natural alternatives and drive management changes in the organic poultry industry. We plan to address this step down through a future rulemaking action. We believe that the current amendment should remain as codified in the interim rule. At this time, the record supports the rationale of the NOSB that synthetic methionine remains critical in organic poultry production and that its removal from the National List would have significant adverse impacts on the industry. Two comments maintained that adequate wholly natural sources of methionine are in fact available and suggested that these alternatives should be sufficient for organic poultry production. The NOSB considered the availability of such alternatives in development of their recommendation and, based upon the public comment received, determined that alternatives are not available in sufficient quantities to meet the needs of the organic poultry industry. We concur with the NOSB's finding and, therefore, disagree with the comments suggesting that there are presently viable alternatives to justify removal of synthetic methionine from the National List. After full consideration of these comments, we have determined that the record supports retaining the provisions in the interim rule to extend the use of synthetic methionine in organic poultry production until October 1, 2012, at the following maximum levels of synthetic methionine per ton of feed: laying chickens—4 pounds; broiler chickens—5 pounds; turkeys and all other poultry—6 pounds. This provision remains consistent with the NOSB's April 29, 2010 recommendation. List of Subjects in 7 CFR Part 205 Administrative practice and procedure, Agriculture, Animals, Archives and records, Imports, Labeling, Organically produced products, Plants, Reporting and recordkeeping requirements, Seals and insignia, Soil conservation. PART 205—NATIONAL ORGANIC PROGRAM Accordingly, the interim rule amending 7 CFR part 205, subpart G published at 75 FR 51919 on August 24, 2010, is adopted as a final rule without change. Dated: March 4, 2011. David R. Shipman, Associate Administrator, Agricultural Marketing Service. [FR Doc. 2011-5716 Filed 3-11-11; 8:45 am]
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U.S. Code
- Accreditation program§ 6514
- National organic production program§ 6503
- State organic certification program§ 6507
- Recordkeeping, investigations, and enforcement§ 6519
- Definitions§ 601
- Congressional statement of findings§ 451
- Congressional statement of findings§ 1031
- Short title§ 301
- Definitions§ 136
- Administrative appeal§ 6520
- Purposes§ 3501
- National List§ 6517
5 references not yet in our index
- 7 CFR 205
- 7 USC 6501-6522
- 7 USC 6517-6518
- 5 USC 601-612
- 5 CFR 1320
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