Unknown. Final rule

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--- schema: federal-register doc_type: fedreg source_file: FR-2010-12-13.xml --- 75 238 Monday, December 13, 2010 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Priority Setting for CHIPRA Pediatric Quality Measures Program: Correction, 77642 C1--2010--31110 Agricultural Marketing Agricultural Marketing Service RULES National Organic Program: Amendments to National List of Allowed and Prohibited Substances (Crops and Processing), 77521-77524 2010-31196 PROPOSED RULES Continuance Referenda:

Nectarines, Pears, and Peaches Grown in California, 77563-77564 2010-31201 Final Free and Restricted Percentages for 2010-2011 Crop Year for Tart Cherries: Tart Cherries Grown in States of Michigan, et al., 77564-77569 2010-31198 Regulations Issued Under Export Grape and Plum Act: Revision to Minimum Requirements, 77561-77563 2010-31197 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 77611-77612 2010-31203 Reestablishment of Plant Variety Protection Board, 77612-77613 2010-31219 Agriculture Agriculture Department See Agricultural Marketing Service See Forest Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 77606-77607 2010-31144 2010-31145 Privacy Act; Systems of Records, 77607-77611 2010-31205 Army Army Department NOTICES Intents To Grant Exclusive Licenses: U.S. Army Owned Inventions to Polymer Processing Institute, 77624 2010-31174 Arts and Humanities, National Foundation See National Foundation on the Arts and the Humanities Broadcasting Broadcasting Board of Governors NOTICES Meetings; Sunshine Act, 77613 2010-31397 Centers Disease Centers for Disease Control and Prevention NOTICES Infectious Diseases and Circumstances Relevant to Notification Requirements, 77642-77644 2010-31149 Meetings:

Disease, Disability, and Injury Prevention and Control Special Emphasis Panel; Pregnancy Risk Assessment Monitoring System, 77645 2010-31143 2010-31146 2010-31147 Civil Rights Civil Rights Commission NOTICES Meetings; Sunshine Act, 77613 2010-31347 Coast Guard Coast Guard RULES Traffic Separation Schemes: Portland, ME; Boston, MA; Narragansett Bay, RI and Buzzards Bay, MA; Chesapeake Bay, VA, and Cape Fear River, NC, 77529-77535 2010-31113 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, 77613-77614 2010-31138 2010-31155 Commodity Futures Commodity Futures Trading Commission PROPOSED RULES Foreign Futures and Options Contracts on a Non-Narrow-Based Security Index: Commission Certification Procedures, 77588-77595 2010-31014 General Regulations and Derivatives Clearing Organizations, 77576-77588 2010-31029 Consumer Product Consumer Product Safety Commission NOTICES Meetings; Sunshine Act, 77623-77624 2010-31350 2010-31351 Defense Department Defense Department See Army Department RULES Federal Acquisition Regulation:

Federal Acquisition Circular 2005-47; Introduction, 77722-77723 2010-30558 Federal Acquisition Circular 2005-47; Small Entity Compliance Guide, 77745-77747 2010-30568 HUBZone Program Revisions, 77727-77733 2010-30560 Limitation on Pass-Through Charges, 77741-77745 2010-30566 Notification of Employee Rights Under the National Labor Relations Act, 77723-77726 2010-30559 Preventing Abuse of Interagency Contracts, 77733-77737 2010-30561 Small Disadvantaged Business Self-Certification, 77737-77739 2010-30563 Technical Amendments, 77745 2010-30567 Uniform Suspension and Debarment Requirement, 77739-77741 2010-30565 Department of Transportation See Pipeline and Hazardous Materials Safety Administration Education Education Department NOTICES Applications for New Awards for 2011 Fiscal Year:

National Institute on Disability and Rehabilitation Research; Small Business Innovation Research Program, 77624-77629 2010-31191 Inviting Applications for New Awards for 2011 Fiscal Year: National Institute on Disability and Rehabilitation Research, etc., 77629-77633 2010-31192 Employment and Training Employment and Training Administration NOTICES Affirmative Determination Regarding Application for Reconsideration: Vaughn Furniture Company, Galax, VA, 77664 2010-31134 Affirmative Determinations Regarding Applications for Reconsideration:

Ananke Inc., Providence, RI, 77664 2010-31137 Amended Certifications Regarding Eligibility To Apply for Worker Adjustment Assistance: Frank Russell Co. et al., Tacoma, WA, 77665 2010-31166 General Motors Co. Technical Center et al., Warren, MI, 77666 2010-31163 Honeywell International, Inc. Automation and Control Solutions Division et al., Rock Island, IL, 77664-77665 2010-31164 Polaris Industries et al., Osceola, WI, 77666 2010-31165 Whirlpool Corp. et al., Fort Smith, AR, 77665 2010-31167 Determinations Regarding Eligibility To Apply for Worker Adjustment Assistance, 77666-77669 2010-31162 Investigations Regarding Certifications of Eligibility To Apply for Worker Adjustment Assistance, 77669-77670 2010-31161 Revised Determinations on Reconsideration:

Sojitz Corp. of America, Seattle, WA, 77670-77671 2010-31136 SuperMedia, LLC, Troy, LLC, 77670 2010-31135 Environmental Protection Environmental Protection Agency RULES Finding of Substantial Inadequacy and SIP Call: Authority To Issue Permits under the Prevention of Significant Deterioration Program to Sources of Greenhouse Gas Emissions, 77698-77719 2010-30854 PROPOSED RULES Approvals and Promulgations of Implementation Plans and Designations of Areas for Air Quality Planning Purposes:

Rome, GA; Determination of Attaining Data for 1997 Annual Fine Particulate Standards, 77595-77597 2010-31208 NOTICES Approvals of Test Marketing Exemptions for Certain New Chemicals, 77634-77635 2010-31215 Cancellation Orders for Certain Pesticide Registrations: Ethofumesate and Monosodium Methanearsonate; Correction, 77635-77636 C1--2010--31212 Meetings: Public Information Exchange on EPA Nanomaterial Case Studies, 77636-77637 2010-31210 Executive Office of the President See Science and Technology Policy Office Federal Aviation Federal Aviation Administration RULES Special Conditions:

Sikorsky Aircraft Corp. Model S-92A Helicopter; Installation of Search and Rescue Automatic Flight Control System, 77524-77528 2010-31188 PROPOSED RULES Airworthiness Directives: General Electric Co. CF6 Series Turbofan Engines, 77570-77572 2010-31172 Proposed Revisions of Class E Airspace: Platinum AK, 77572-77573 2010-31185 Savoonga, AK, 77574-77576 2010-31184 Shungnak AK, 77573-77574 2010-31186 Special Conditions: Gulfstream Model GVI Airplane; Electronic Flight Control System Mode Annunciation, 77569-77570 2010-31177 NOTICES Noise Exposure Maps:

Manchester-Boston Regional Airport; Manchester, NH, 77693-77694 2010-31178 Federal Communications Federal Communications Commission PROPOSED RULES Allocations and Designations of Spectrums for Fixed-Satellite Services: 37.5-38.5 GHz, 40.5-41.5 GHz and 48.2-50.2 GHz Frequency Bands; Correction, 77602 C1--2010--30984 Federal Emergency Federal Emergency Management Agency PROPOSED RULES Proposed Flood Elevation Determinations, 77598-77602 2010-31151 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control:

Formations of, Acquisitions by, and Mergers of Bank Holding Companies; Correction, 77637-77638 C1--2010--31126 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 77638 2010-31125 Federal Trade Federal Trade Commission NOTICES Requests for Early Termination of Waiting Period Under Premerger Notification Rules, 77638-77641 2010-31092 Fish Fish and Wildlife Service NOTICES Endangered and Threatened Wildlife and Plants: Incidental Take Permit Extension; Proposed Low-Effect Habitat Conservation Plan;

Deltona Family YMCA, Volusia County, FL, 77651-77652 2010-31148 Food and Drug Food and Drug Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Color Additive Certification Requests and Recordkeeping, 77645-77647 2010-31195 Meetings: Medical Device User Fee Program; Request for Notification of Patient and Consumer Advocacy Group Intentions to Participate, 77647-77648 2010-31160 Foreign Trade Foreign-Trade Zones Board NOTICES Proposed Foreign-Trade Zones Under Alternative Site Framework:

Terrebonne Parish, LA; Application Filed, 77614-77615 2010-31223 Forest Forest Service NOTICES Meetings: Gogebic Resource Advisory Committee, 77613 2010-31170 General Services General Services Administration RULES Federal Acquisition Regulation: Federal Acquisition Circular 2005-47; Introduction, 77722-77723 2010-30558 Federal Acquisition Circular 2005-47; Small Entity Compliance Guide, 77745-77747 2010-30568 HUBZone Program Revisions, 77727-77733 2010-30560 Limitation on Pass-Through Charges, 77741-77745 2010-30566 Notification of Employee Rights under the National Labor Relations Act, 77723-77726 2010-30559 Preventing Abuse of Interagency Contracts, 77733-77737 2010-30561 Small Disadvantaged Business Self-Certification, 77737-77739 2010-30563 Technical Amendments, 77745 2010-30567 Uniform Suspension and Debarment Requirement, 77739-77741 2010-30565 Geological Geological Survey NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Assessment of the Business Requirements and Benefits of Enhanced National Elevation Data, 77652 2010-31169 Health and Human Health and Human Services Department See Agency for Healthcare Research and Quality See Centers for Disease Control and Prevention See Food and Drug Administration See Health Resources and Services Administration See National Institutes of Health NOTICES Findings of Research Misconduct, 77641-77642 2010-31168 Health Resources Health Resources and Services Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 77648-77649 2010-31236 2010-31238 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency Housing Housing and Urban Development Department NOTICES Buy American Exceptions Under 2009 American Recovery and Reinvestment Act, 77650-77651 2010-31234 Interior Interior Department See Fish and Wildlife Service See Geological Survey See Land Management Bureau See National Park Service International Boundary International Boundary and Water Commission, United States and Mexico NOTICES Environmental Assessments;

Availability, etc.: Arroyo Colorado South Levee Rehabilitation Project in Cameron and Hidalgo Counties, TX, 77662 2010-31141 International Trade Adm International Trade Administration NOTICES Extensions of Time Limits for Final Results of Antidumping Duty Administrative Reviews: Corrosion-Resistant Carbon Steel Flat Products from Republic of Korea, 77615 2010-31217 International Trade Com International Trade Commission NOTICES Investigations: Certain Printing and Imaging Devices and Components Thereof, 77662-77663 2010-31124 Labor Department Labor Department See Employment and Training Administration See Occupational Safety and Health Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 77663-77664 2010-31193 Land Land Management Bureau NOTICES Environmental Impact Statements; Availability, etc.: Battle Mountain District, NV, 77652-77654 2010-31207 Pattern Energy Group Ocotillo Express Wind Energy Project, Imperial County, CA, 77654-77655 2010-31139 Proposed Supplementary Rules for Public Lands: Saguache, Alamosa, Rio Grande, Conejos, and Costilla Counties, CO, 77655-77657 2010-31204 Public Land Orders: No. 7754; Extension of Public Land Order No. 6818, Nevada, 77658-77659 2010-31211 No. 7755;

Withdrawal of Public Lands and Reserved Federal Minerals for Ash Meadows National Wildlife Refuge, NV, 77658 2010-31209 Realty Actions: Recreation and Public Purposes Act Classification for Conveyance of Public Lands in San Juan County, UT, 77659 2010-31206 Stays of Filings of Plats, 77659-77660 2010-31142 Mexico and United States, International Boundary and Water Commission See International Boundary and Water Commission, United States and Mexico NASA National Aeronautics and Space Administration RULES Federal Acquisition Regulation:

Federal Acquisition Circular 2005-47; Introduction, 77722-77723 2010-30558 Federal Acquisition Circular 2005-47; Small Entity Compliance Guide, 77745-77747 2010-30568 HUBZone Program Revisions, 77727-77733 2010-30560 Limitation on Pass-Through Charges, 77741-77745 2010-30566 Notification of Employee Rights under the National Labor Relations Act, 77723-77726 2010-30559 Preventing Abuse of Interagency Contracts, 77733-77737 2010-30561 Small Disadvantaged Business Self-Certification, 77737-77739 2010-30563 Technical Amendments, 77745 2010-30567 Uniform Suspension and Debarment Requirement, 77739-77741 2010-30565 NOTICES National Environmental Policy Act:

Scientific Balloon Program, 77673-77674 2010-31239 National Credit National Credit Union Administration NOTICES Meetings; Sunshine Act, 77674 2010-31391 National Foundation National Foundation on the Arts and the Humanities NOTICES Meetings: Arts Advisory Panel, 77674-77675 2010-31156 National Institute National Institutes of Health NOTICES Meetings: National Institute of Allergy and Infectious Diseases, 77650 2010-31181 National Institute of Diabetes and Digestive and Kidney Diseases, 77649-77650 2010-31182 National Oceanic National Oceanic and Atmospheric Administration RULES Endangered and Threatened Wildlife and Plants:

Take Prohibitions for Threatened Southern Distinct Population Segment of North American Green Sturgeon, 77528-77529 2010-31216 Fisheries of Exclusive Economic Zone Off Alaska: Steller Sea Lion Protection Measures for Bering Sea and Aleutian Islands Groundfish Fisheries, 77535-77560 2010-31226 PROPOSED RULES Endangered and Threatened Species: 90-Day Finding on Petitions to Delist Eastern Distinct Population Segment of Steller Sea Lion, 77602-77605 2010-31232 NOTICES Application Requests:

Hawaiian Islands Humpback Whale National Marine Sanctuary Advisory Council, 77615-77616 2010-31180 Applications for Permit Amendments: Marine Mammals (File No. 14334), 77616 2010-31221 Requesting Nominations for Marine Protected Areas Federal Advisory Committee, 77617 2010-31187 Taking of Marine Mammals Incidental to Specified Activities: Construction of East Span of San Francisco-Oakland Bay Bridge, 77617-77623 2010-31214 National Park National Park Service NOTICES National Register of Historic Places:

Notification of Pending Nominations and Related Actions, 77660-77662 2010-31233 Pending Nominations and Related Actions, 77660 2010-31231 National Register of Historic Places; Correction: Pending Nominations and Related Actions, 77662 C1--2010--30112 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Confirmatory Orders: AREVA NP, Inc., 77675-77677 2010-31175 Exemptions: Southern Nuclear Operating Co., Inc.; Edwin I Hatch Nuclear Plant (Unit No. 2), 77677-77679 2010-31173 Occupational Safety Health Adm Occupational Safety and Health Administration NOTICES Expansion of Scope of NRTL Recognition of MET Laboratories, Inc.;

Correction of Scope of NRTL Recognition of FM Approvals, LLC, 77671-77673 2010-31190 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 77694-77695 2010-31129 Science Technology Science and Technology Policy Office NOTICES Meetings: President's Council of Advisors on Science and Technology, 77679-77680 2010-31229 Securities Securities and Exchange Commission NOTICES Meetings;

Sunshine Act, 77680-77681 2010-31291 2010-31393 Self-Regulatory Organizations; Proposed Rule Changes: New York Stock Exchange LLC, 77687-77689 2010-31200 NYSE Amex LLC, 77685-77687 2010-31199 NYSE Arca, Inc., 77681-77685, 77689-77691 2010-31132 2010-31224 Small Business Small Business Administration NOTICES Revocation of License of Small Business Investment Company, 77691 2010-31153 Surrender of License of Small Business Investment Company, 77691 2010-31152 Tennessee Tennessee Valley Authority NOTICES Douglas and Nolichucky Tributary Reservoirs Land Management Plan:

Cocke, Greene, Hamblen, Jefferson, and Sevier Counties, TN, 77691-77693 2010-31171 Transportation Department Transportation Department See Federal Aviation Administration See Pipeline and Hazardous Materials Safety Administration Separate Parts In This Issue Part II Environmental Protection Agency, 77698-77719 2010-30854 Part III Defense Department, 77722-77747 2010-30558 2010-30568 2010-30560 2010-30566 2010-30559 2010-30561 2010-30563 2010-30567 2010-30565 General Services Administration, 77722-77747 2010-30558 2010-30568 2010-30560 2010-30566 2010-30559 2010-30561 2010-30563 2010-30567 2010-30565 National Aeronautics and Space Administration, 77722-77747 2010-30558 2010-30568 2010-30560 2010-30566 2010-30559 2010-30561 2010-30563 2010-30567 2010-30565 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. 75 238 Monday, December 13, 2010 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 [Document Number AMS-TM-09-0003; TM-08-06FR] RIN 0581-AC91 National Organic Program; Amendments to the National List of Allowed and Prohibited Substances (Crops and Processing) AGENCY:

Agricultural Marketing Service, USDA. ACTION: Final rule. SUMMARY: This final rule amends the U.S. Department of Agriculture's

(USDA)National List of Allowed and Prohibited Substances (National List) to enact six recommendations submitted to the Secretary of Agriculture (Secretary) by the National Organic Standards Board

(NOSB)from November 30, 2007, and May 22, 2008. This final rule adds aqueous potassium silicate and sodium carbonate peroxyhydrate, along with any restrictive annotations, for use in organic crop production, and adds gellan gum, fortified cooking wine—Marsala, fortified cooking wine—sherry, and tragacanth gum, along with any restrictive annotations, for use in organic handling. This final rule also removes the listing for glycerine oleate (glycerol monooleate) as the use exemption for this substance as a synthetic inert ingredient in organic crop production expired on December 31, 2006. DATES: *Effective Date:* This rule becomes effective December 14, 2010. FOR FURTHER INFORMATION CONTACT: Melissa Bailey, Director, Standards Division, *Telephone:*

(202)720-3252; *Fax:*

(202)205-7808. SUPPLEMENTARY INFORMATION: I. Background On December 21, 2000, the Secretary established, within the National Organic Program

(NOP)[7 CFR part 205], the National List regulations §§ 205.600 through 205.607. This National List identifies the synthetic substances that may be used and the nonsynthetic (natural) substances that may not be used in organic production. The National List also identifies synthetic, nonsynthetic nonagricultural and nonorganic agricultural substances that may be used in organic handling. The Organic Foods Production Act of 1990, as amended, (7 U.S.C. 6501 *et seq.* ), (OFPA), and NOP regulations, in § 205.105, specifically prohibit the use of any synthetic substance in organic production and handling unless the synthetic substance is 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 National List has been amended thirteen times, 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), and August 24, 2010 (75 FR 51919). Additionally, a proposed amendment to the National List was published on November 8, 2010 (75 FR 68505). This final rule amends the National List to enact six recommendations submitted to the Secretary by the NOSB on November 30, 2007, and May 22, 2008, and removes the listing of one substance, as its use exemption has expired. II. Overview of Amendments The following provides an overview of the amendments made to designated sections of the National List regulations: Section 205.601 Synthetic Substances Allowed for Use in Organic Crop Production This final rule amends paragraph

(a)of § 205.601 of the National List regulations by adding new paragraph (a)(8) for the addition of one substance as follows: Sodium carbonate peroxyhydrate (CAS #-15630-89-4)—Federal law restricts the use of this substance in food crop production to approved food uses identified on the product label. This final rule amends paragraphs

(e)and

(i)of § 205.601 by:

(1)Redesignating paragraphs (e)(2) through (e)(9), and paragraphs (i)(1) through (i)(11), as paragraphs (e)(3) through (e)(10) and (i)(2) through (i)(12), respectively; and

(2)adding new paragraphs (e)(2) and (i)(1) to add one substance as follows: aqueous potassium silicate (CAS #-1312-76-1)—the silica used in the manufacture of potassium silicate must be sourced from naturally occurring sand. This final rule amends paragraph (m)(2) of § 205.601 of the National List regulations by:

(1)Removing the expired exemption for glycerine oleate (glycerol monooleate) (CAS #-37220-82-9)—for use only until December 31, 2006; and

(2)redesignating paragraph (m)(2)(ii) as new paragraph (m)(2). Section 205.605 Nonagricultural (Nonorganic) Substances Allowed as Ingredients in or on Processed Products Labeled as “Organic” or “Made With Organic (Specified Ingredients or Food Group(s)).” This final rule amends § 205.605(a) of the National List regulations by adding one substance in alphabetical order as follows: Gellan gum (CAS #-71010-52-1)—high-acyl form only. Section 205.606 Nonorganically Produced Agricultural Products Allowed as Ingredients in or on Processed Products Labeled as “Organic.” This final rule amends § 205.606 of the National List regulations by:

(1)Redesignating paragraphs

(g)through

(t)and

(u)through

(w)as paragraphs

(h)through

(u)and

(w)through (y); and

(2)adding new paragraph

(g)for the addition of two substances as follows: Fortified cooking wines,

(1)Marsala,

(2)sherry; and

(3)adding new paragraph

(v)for the addition of one substance as follows: Tragacanth gum (CAS #-9000-65-1). III. Related Documents Three notices were published regarding the meetings of the NOSB and its deliberations on recommendations and substances petitioned for amending the National List. Substances and recommendations included in this final rule were announced for NOSB deliberation in the following **Federal Register** Notices:

(1)72 FR 10971, March 12, 2007, (Gellan gum);

(2)72 FR 58046, October 12, 2007, (Potassium silicate, Sodium carbonate peroxyhydrate, Gellan gum); and

(3)73 FR 18491, April 4, 2008, (Marsala cooking wine, Sherry cooking wine, Tragacanth gum). The recommendation to allow the use of the six substances in this final rule, and the removal of the expired substance, was published as a proposed rule on June 3, 2009 (74 FR 26591). IV. Statutory and Regulatory Authority The OFPA 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 on 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 (OMB). 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. 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 EPA 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, the Agricultural Marketing Service

(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). The 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 effect of this final rule would be to allow the use of additional substances in agricultural production and handling. This action would modify the regulations published in the final rule and would provide small entities with more tools to use in day-to-day farming and handling operations. The AMS concludes that the economic impact of this addition of allowed substances, if any, would be minimal and beneficial to 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, which include producers, 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. According to USDA Economic Research Service

(ERS)data based on information from USDA-accredited certifying agents, the number of certified U.S. organic crop and livestock operations totaled nearly 13,000 and certified organic acreage exceeded 4.8 million acres in 2008. 1 ERS, based upon the list of certified operations maintained by the National Organic Program, estimated the number of certified handling operations was 3,225 in 2007. 2 AMS believes that most of these entities would be considered small entities under the criteria established by the SBA. 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 U.S. Department of Agriculture, Economic Research Service, 2009. *Data Sets: Procurement and Contracting by Organic Handlers: Documentation. http://www.ers.usda.gov/Data/OrganicHandlers/Documentation.htm.* The U.S. sales of organic food and beverages have grown from $3.6 billion in 1997 to nearly $21.1 billion in 2008. 3 The organic industry is viewed as the fastest growing sector of agriculture, representing over 3 percent of overall food sales in 2009. Between 1990 and 2008, organic food sales have historically demonstrated a growth rate between 15 to 24 percent each year. In 2009, organic food sales grew 5.1%. 4 3 Dimitri, C., and L. Oberholtzer. 2009. *Marketing U.S. Organic Foods: Recent Trends from Farms to Consumers,* Economic Information Bulletin No. 58, U.S. Department of Agriculture, Economic Research Service, *http://www.ers.usda.gov/Publications/EIB58.* 4 Organic Trade Association's *2010 Organic Industry Survey, http://www.ota.com.* In addition, USDA has 98 accredited certifying agents

(ACAs)who provide certification services to producers and handlers under the NOP. A complete list of names and addresses of ACAs may be found on the AMS NOP Web site, at *http://www.ams.usda.gov/nop.* The AMS believes that most of these accredited certifying agents 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 regulation 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. Received Comments on Proposed Rule AMS received comments from 9 submitters on the proposed rule TM-08-06. Comments were received from handlers, a trade association, a non-profit organization, an accredited certifying agent, and an industry group. There was support among the comments for the allowance of each of the six proposed use exemptions. However, a few of those supporting comments suggested modifications to the proposed amendments. One comment also expressed support for the removal of the expired listing for glycerol monooleate. One additional commenter expressed blanket opposition to allowing these substances in organic production and handling, but did not offer any specific objections. The comments can be viewed at: *http://www.regulations.gov/.* One comment in favor of the addition of aqueous potassium silicate to § 205.601 requested that the NOP clarify what measures would be used to verify and enforce the source restriction, and what oversight and technical assistance the NOP will provide to certifying agents and their subcontractors. The comment refers to the annotation that the silica used in the manufacture of potassium silicate must be sourced from naturally occurring sand. The National List contains a number of substances which have annotations that specify source or processing restrictions, particularly for handling substances. The NOP has previously advised that ACAs obtain written documentation from the manufacturer(s) of the input product(s) to discern whether a substance/product conforms to restrictive annotations. One comment in favor of adding tragacanth gum to § 205.606 requested that the NOSB further consider the impact of pesticides and fertilizers in the production of nonorganic ingredients, such as tragacanth gum and wine grapes (in reference to the cooking wines). The commenter cited the criteria established in 7 U.S.C. 6518(m), which includes the probability of environmental contamination during manufacture, use, misuse, or disposal of the substance, effects of the substance on biological and chemical interactions in the agroecosystem, and its compatibility with a system of sustainable agriculture. During the May 2008 meeting, the Board discussed how to consider the impact of conventional production methods for substances petitioned for addition to § 205.606. In the context of wine grapes used to produce fortified cooking wines, the Board clarified that its evaluation covered the production and use of the finished wine product and not the production of the raw ingredients in the wine. Thus, in accordance with 7 U.S.C. 6518(m), the Board considered potential adverse effects upon the agroecosystem from the manufacture, use and disposal of the fortified cooking wine and not the individual ingredients in the wine. The Board determined that the fortified cooking wines, sherry and Marsala, satisfied the OFPA criteria in section 6518(m). In regards to tragacanth gum, the Board reviewed the production process for the gum and found it to be identical to a water extracted gum that is currently listed in § 205.606. At its May 20-22, 2008, meeting in Baltimore, MD, the NOSB evaluated tragacanth gum against the criteria established under 7 U.S.C. 6517 and 6518, and concluded that tragacanth gum is consistent with the OFPA evaluation criteria. Members of the public are always invited to submit comments regarding specific production concerns of any particular substance that has been petitioned for addition to § 205.606. The NOP solicits such comments in notices of NOSB meetings and proposed rules, both of which are published in the **Federal Register** and on the NOP Web site. Changes Based on Comments Gellan Gum Several comments addressed gellan gum. These comments favored the addition of gellan gum to § 205.605, and several specifically referenced support for the listing of gellan gum as nonsynthetic substance on § 205.605(a). One comment in support of the exemption for gellan gum, recommended an annotation to allow only the native form of gellan gum, *i.e.,* the high-acyl form. The comment stated that low-acyl gellan gum is chemically modified by alkali treatment prior to alcohol precipitation and is, therefore, synthetic. The comment indicated that a restriction of the exemption to the high-acyl form aligns with the intent of the NOSB as conveyed during the November 27-30, 2007 meeting discussion. There are 2 forms of gellan gum: High- and low-acyl. To manufacture the low-acyl form, an alkali is added and the temperature is raised to remove acetyl groups. A strong acid is then used to lower the pH and the gum is recovered from solution by clarification and precipitation. The high-acyl form is not subject to deacetylation with an alkali salt. After fermentation, the high-acyl form is precipitated out of solution with isopropyl alcohol. We believe the different manufacturing processes for high- and low-acyl gellan gum merits a revision to the proposed amendment to clarify that only the high-acyl form of gellan gum may be classified as nonsynthetic. Deacetylation, the removal of acetyl group(s) from molecules, results in chemical change. Thus, in accordance with the NOP definition of synthetic, the resulting substance would be synthetic. Based upon this reasoning, we agree with the comment that the recommendation to add gellan gum as a nonsynthetic substance pertains only to the high-acyl form. Therefore, we have amended the listing by adding the annotation “high-acyl form only.” Changes Requested But Not Made Fortified Cooking Wines—Marsala and Sherry Two comments addressed Marsala and sherry fortified cooking wines. One comment did not support the listing on the basis that organic versions of these cooking wines are commercially available, but failed to provide documentation to support this claim. One comment requested an annotation to prohibit fortified wines that contain synthetic sulfites, such as sulfur dioxide or potassium metabisulfite. The comment referenced the restriction of sulfur dioxide to wines that are “made with organic grapes” in questioning the legal basis for allowing cooking wines containing sulfites to be listed on § 205.606 and, therefore, to be used to produce “organic” products. In its discussion at the May 20-22, 2008 meeting, the NOSB acknowledged that the manufacturer cited in the fortified cooking wine petitions did not add sulfites to its sherry and Marsala cooking wines. However, the NOSB did not recommend prohibiting sherry or Marsala cooking wines which contain added sulfites. We believe the recommendation is consistent with OFPA, § 6510(a)(3), which prohibits the addition of sulfites except in the production of wine. Therefore, we are not adopting the proposed annotation to prohibit conventional forms of Marsala and sherry fortified cooking wines which contain added sulfites. F. Effective Date This final rule reflects recommendations submitted to the Secretary by the NOSB. The substances being added to the National List were based on petitions from the industry and evaluated by the NOSB using criteria in the Act and the regulations. Because these substances are crucial to organic crop production and processing operations, producers should be able to use them in their operations as soon as possible. Accordingly, AMS finds that good cause exists under 5 U.S.C. 553(d)(3) for not postponing the effective date of this rule until 30 days after publication in the **Federal Register** . 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. For the reasons set forth in the preamble, 7 CFR part 205, subpart G is amended as follows: PART 205—NATIONAL ORGANIC PROGRAM 1. The authority citation for 7 CFR part 205 continues to read as follows: Authority: 7 U.S.C. 6501-6522. 2. Section 205.601 is amended by: A. Adding new paragraph (a)(8); B. Redesignating paragraphs (e)(2) through (e)(9) as (e)(3) through (e)(10) and adding new paragraph (e)(2); C. Redesignating paragraphs (i)(1) through (i)(11) as (i)(2) through (i)(12) and adding new paragraph (i)(1); and D. Revising paragraph (m)(2). The additions and revisions read as follows: § 205.601 Synthetic substances allowed for use in organic crop production.

(a)* * *

(8)Sodium carbonate peroxyhydrate (CAS #-15630-89-4)—Federal law restricts the use of this substance in food crop production to approved food uses identified on the product label.

(e)* * *

(2)Aqueous potassium silicate (CAS #-1312-76-1)—the silica, used in the manufacture of potassium silicate, must be sourced from naturally occurring sand.

(i)* * *

(1)Aqueous potassium silicate (CAS #-1312-76-1)—the silica, used in the manufacture of potassium silicate, must be sourced from naturally occurring sand.

(m)* * *

(2)EPA List 3—Inerts of unknown toxicity—for use only in passive pheromone dispensers. 2. Section 205.605 is amended by adding one new substance in alphabetical order to paragraph

(a)to read as follows: § 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s)).”

(a)* * * Gellan gum (CAS # 71010-52-1)—high-acyl form only. 3. Section 205.606 is amended by: A. Redesignating paragraphs

(g)through

(t)and

(u)through

(w)as paragraphs

(h)through

(u)and

(w)through

(y)respectively; B. Adding new paragraphs

(g)and

(v)to read as follows: § 205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as “organic.”

(g)Fortified cooking wines.

(1)Marsala.

(2)Sherry.

(v)Tragacanth gum (CAS #-9000-65-1). Dated: December 7, 2010. David R. Shipman, Acting Administrator, Agricultural Marketing Service. [FR Doc. 2010-31196 Filed 12-10-10; 8:45 am]

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