Unknown. Final rule

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A 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-2012-02-14.xml --- 77 30 Tuesday, February 14, 2012 Contents Agency Agency for International Development RULES Partner Vetting in USAID Acquisitions, 8166-8174 2012-3239 Agricultural Marketing Agricultural Marketing Service RULES National Organic Program: Amendments to the National List of Allowed and Prohibited Substances, 8089-8092 2012-2938 Agriculture Agriculture Department See Agricultural Marketing Service See Forest Service See Natural Resources Conservation Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 8213-8214 2012-3316 2012-3318 Alcohol Tobacco Firearms Alcohol, Tobacco, Firearms, and Explosives Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Certificate of Compliance, 8276-8277 2012-3395 Transactions Among Licensee/Permittees and Among Licensees and Holders of User Permits, 8277 2012-3396 Army Army Department NOTICES Availability for Exclusive, Non-Exclusive, or Partially-Exclusive Licensing of an Invention:

Computer Controlled System for Laser Energy Delivery to the Retina, 8223 2012-3348 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals; Correction, 8260 C1--2012--2821 Commerce Commerce Department See International Trade Administration See National Institute of Standards and Technology See National Oceanic and Atmospheric Administration See Patent and Trademark Office NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 8216 2012-3393 Committee Implementation Committee for the Implementation of Textile Agreements NOTICES Determinations under Dominican Republi-Central America-U.S. Free Trade Agreement, 8221-8222 2012-3420 Commodity Futures Commodity Futures Trading Commission PROPOSED RULES Prohibitions and Restrictions: Proprietary Trading and Certain Interests In, and Relationships with, Hedge Funds and Covered Funds, 8332-8447 2012-935 NOTICES Requests for Nominations:

Technology Advisory Committee's Subcommittee on Automated and High Frequency Trading, 8222 2012-3409 Defense Department Defense Department See Army Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 8222-8223 2012-3345 Department of Transportation See Pipeline and Hazardous Materials Safety Administration Education Education Department NOTICES Applications for New Awards: Developing Hispanic-Serving Institutions Program, 8228-8233 2012-3421 National Institute on Disability and Rehabilitation Research, etc., 8223-8228 2012-3414 Final Priority:

National Institute on Disability and Rehabilitation Research, etc., 8234-8236 2012-3416 Meetings: National Assessment Governing Board, 8236-8238 2012-3314 Employee Benefits Employee Benefits Security Administration RULES Summary of Benefits, Coverage and Uniform Glossary, 8668-8706 2012-3228 Summary of Benefits, Coverage and Uniform Glossary: Templates, Instructions, and Related Materials; and Guidance for Compliance, 8706-8709 2012-3230 Employment and Training Employment and Training Administration NOTICES Amended Certifications Regarding Eligibility to Apply for Worker Adjustment Assistance:

Kimberly-Clark Worldwide, Inc., et al., Everett, WA, 8279 2012-3325 Determinations Regarding Eligibility to Apply for Worker Adjustment Assistance, 8279-8284 2012-3322 2012-3323 Negative Determination on Remand Western Digital Technologies, Inc., Hard Drive Development Engineering Group, Lake Forest, CA, 8284-8287 2012-3324 Termination of Investigations: Quad/Graphics, Quad Graphics, Inc., Including On-Site Leased Workers from SPS Temporaries, Depew, NY, 8287-8288 2012-3326 Energy Department Energy Department See Energy Efficiency and Renewable Energy Office See Federal Energy Regulatory Commission PROPOSED RULES Energy Conservation Program:

Standards for Standby Mode and Off Mode for Microwave Ovens, 8526-8574 2012-2784 Test Procedures for Central Air Conditioners and Heat Pumps; Meetings, 8178-8179 2012-3375 Energy Efficiency Energy Efficiency and Renewable Energy Office NOTICES Refrigerator and Refrigerator-Freezer Test Procedure Waivers: GE Appliances, 8238-8244 2012-3371 Environmental Protection Environmental Protection Agency RULES EPAAR Prescription for Work Assignments, 8174-8176 2012-3292 Quality Assurance Requirements for Continuous Opacity Monitoring Systems at Stationary Sources, 8160-8166 2012-3379 PROPOSED RULES Implementation of the 2008 National Ambient Air Quality Standards for Ozone:

Nonattainment Area Classifications Approach, Attainment Deadlines, etc., 8197-8209 2012-3284 National Emissions Standards for Hazardous Air Pollutants: Secondary Aluminum Production, 8576-8629 2012-2874 Quality Assurance Requirements for Continuous Opacity Monitoring Systems at Stationary Sources, 8209-8211 2012-3378 Revised Responses to Designation Recommendations from Illinois, Indiana, and Wisconsin for 2008 Ozone Standards, 8211-8212 2012-3373 NOTICES Adequacy Status; Carbon Monoxide Maintenance Plan:

Anchorage, AK, 8252-8253 2012-3389 Proposed Settlements: Hidden Lane Landfill Superfund Site, 8253-8254 2012-3427 Renewable Fuels Produced from Palm Oil: Data Availability, Extension of Comment Period, 8254-8255 2012-3413 Settlements: Constitution Road Drum Superfund Site, Atlanta, Dekalb County, GA, 8255 2012-3426 Executive Office of the President See Presidential Documents Farm Credit Farm Credit Administration PROPOSED RULES Disclosure to Investors in Bank Debt Obligations of Farm Credit System, 8179-8181 2012-3411 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives:

Turbomeca S.A. Turboshaft Engines, 8092-8094 2012-3255 PROPOSED RULES Airworthiness Directives: Fokker Services B.V. Airplanes, 8181-8183 2012-3387 NOTICES Meetings: RTCA Special Committee 225, Rechargeable Lithium Batteries and Battery Systems, Small and Medium Size, 8325 2012-3364 Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 8255-8257 2012-3320 2012-3321 Meetings; Sunshine Act, 8257-8258 2012-3590 Federal Election Federal Election Commission NOTICES Meetings;

Sunshine Act, 8258 2012-3532 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Federal Assistance for Offsite Radiological Emergency Planning, 8272-8273 2012-3452 National Flood Insurance Program; Mortgage Portfolio Protection Program, 8273 2012-3454 PrepCAST, 8272 2012-3444 Federal Energy Federal Energy Regulatory Commission RULES Technical Corrections to Commission Regulations, 8095 2012-3317 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 8245-8246 2012-3407 Applications: Alabama Power Co., 8246-8247 2012-3402 Bluewater Gas Storage, LLC, 8248-8249 2012-3404 Tennessee Gas Pipeline Co., LLC, 8247-8248 2012-3405 Combined Filings, 8249-8250 2012-3382 2012-3383 Establishing Comment Periods: California Independent System Operator Corp., 8250-8251 2012-3406 Initial Market-Based Rate Filing Including Requests for Blanket Section 204 Authorization: Rocky Ridge Wind Project, LLC, 8251 2012-3381 Verus Energy Trading, LLC, 8251 2012-3384 Preliminary Permit Applications:

International Consortium of Energy Managers, 8252 2012-3403 John B. Crockett, 8251-8252 2012-3401 Federal Railroad Federal Railroad Administration NOTICES Petitions for Waiver of Compliance, 8325-8326 2012-3346 2012-3347 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 8258 2012-3358 Proposals to Engage in or to Acquire Companies Engaged in Permissible Nonbanking Activities, 8258 2012-3357 Financial Crimes Financial Crimes Enforcement Network RULES Anti-Money Laundering Program and Suspicious Activity Report Filing Requirements for Residential Mortgage Lenders and Originators, 8148-8160 2012-3074 Fish Fish and Wildlife Service RULES Endangered and Threatened Wildlife and Plants:

Designation of Critical Habitat for Nine Bexar County, TX, Invertebrates, 8450-8523 2012-2195 Determination of Endangered Status for Rayed Bean and Snuffbox Mussels throughout their Ranges, 8632-8665 2012-2940 Food and Drug Food and Drug Administration RULES Medical Devices: Cardiovascular Devices; Classification of Endovascular Suturing System, 8117-8119 2012-3398 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Device Reporting:

Manufacturer, Importer, User Facility, and Distributor Reporting, 8260-8262 2012-3344 Draft Guidance; Availability: Investigational New Drug Applications for Positron Emission Tomography Drugs, 8262 2012-3319 Meetings: Dermatologic and Ophthalmic Drugs Advisory Committee; Amendment, 8262-8263 2012-3343 Forest Forest Service NOTICES Requests for Nominations: Black Hills National Forest Advisory Board, 8214-8215 2012-3342 Health and Human Health and Human Services Department See Centers for Medicare & Medicaid Services See Food and Drug Administration See National Institutes of Health RULES Summary of Benefits, Coverage and Uniform Glossary, 8668-8706 2012-3228 Summary of Benefits, Coverage and Uniform Glossary:

Templates, Instructions, and Related Materials; and Guidance for Compliance, 8706-8709 2012-3230 NOTICES Evaluation Report and Recommendations; Availability: LUMI-CELL Test Method for Identifying Human Estrogen Receptor Agonist and Antagonist Activity of Chemicals, 8258-8260 2012-3437 Homeland Homeland Security Department See Federal Emergency Management Agency Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Capture Energy Efficiency Measures for Public and Indian Housing Units, 8273-8274 2012-3386 Local Appeals to Single-Family Mortgage Limits, 8274-8275 2012-3385 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See Surface Mining Reclamation and Enforcement Office Internal Revenue Internal Revenue Service RULES Definition of a Taxpayer, 8120-8127 2012-3352 Foreign Tax Credit Splitting Events, 8127-8143 2012-3356 Section 482: Methods to Determine Taxable Income in Connection with Cost Sharing Arrangement;

Correction, 8143-8144 2012-3351 2012-3353 Summary of Benefits, Coverage and Uniform Glossary, 8668-8706 2012-3228 Summary of Benefits, Coverage and Uniform Glossary: Templates, Instructions, and Related Materials; and Guidance for Compliance, 8706-8709 2012-3230 PROPOSED RULES Foreign Tax Credit Splitting Events, 8184-8185 2012-3350 NOTICES Meetings: Taxpayer Advocacy Panel Bankruptcy Compliance Project Committee, 8328 2012-3365 Taxpayer Advocacy Panel Face-to-Face Service Methods Project Committee, 8328-8329 2012-3363 Taxpayer Advocacy Panel Joint Committee, 8327 2012-3354 Taxpayer Advocacy Panel Refund Processing Communications Project Committee, 8327-8328 2012-3366 Taxpayer Advocacy Panel Return Processing Delays Project Committee, 8328 2012-3368 Taxpayer Advocacy Panel Small Business/Self-Employed Decreasing Non-Filers Project Committee, 8329 2012-3360 Taxpayer Advocacy Panel Tax Forms and Publications Project Committee, 8329-8330 2012-3361 Taxpayer Advocacy Panel Taxpayer Burden Reduction Project Committee, 8329 2012-3355 Taxpayer Advocacy Panel Toll-Free Project Committee, 8328 2012-3367 International Trade Adm International Trade Administration RULES Antidumping Proceedings:

Calculation of Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Duty Proceedings; Final Modification, 8101-8114 2012-3290 NOTICES Requests for Stakeholder Comments on National Travel and Tourism Strategies, 8216-8217 2012-3400 International Trade Com International Trade Commission RULES Retrospective Analysis of Existing Rules, 8114-8116 2012-3267 Justice Department Justice Department See Alcohol, Tobacco, Firearms, and Explosives Bureau See Justice Programs Office NOTICES Meetings:

National Advisory Committee on Violence Against Women, 8275-8276 2012-3374 Justice Programs Justice Programs Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 8277-8278 2012-3394 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Victims of Crime Act, Crime Victim Assistance Grant Program Performance Report, 8278-8279 2012-3370 Labor Department Labor Department See Employee Benefits Security Administration See Employment and Training Administration See Mine Safety and Health Administration Land Land Management Bureau NOTICES Meetings:

Rio Grande Natural Area Commission, 8275 2012-3372 Mine Mine Safety and Health Administration NOTICES State Mine Health and Safety Grants, 8288 2012-3341 National Institute National Institute of Standards and Technology NOTICES Evaluating the Usability of Electronic Health Record Systems, 8217 2012-3415 National Institute National Institutes of Health NOTICES Exclusive Licenses: Development of Anti-Mesothelin Targeted Immunotoxins for the Treatment of Cancer, 8263-8264 2012-3410 Government-Owned Inventions;

Availability for Licensing, 8264-8266 2012-3412 Meetings: Center for Scientific Review, 8266-8270 2012-3434 2012-3441 2012-3443 Eunice Kennedy Shriver National Institute of Child Health and Human Development, 8271 2012-3439 National Cancer Institute; Amended, 8268 2012-3430 National Eye Institute, 8266 2012-3432 National Heart, Lung, and Blood Institute, 8271-8272 2012-3435 National Human Genome Research Institute, 8268-8269 2012-3448 National Institute of Allergy and Infectious Diseases, 8269 2012-3447 National Institute of Dental and Craniofacial Research, 8268 2012-3449 National Institute of Neurological Disorders and Stroke, 8268 2012-3438 Office of the Director, 8270-8271 2012-3440 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska:

Pacific Cod by Vessels Using Pot Gear in the Central Regulatory Area of the Gulf of Alaska, 8177 2012-3399 Reallocation of Pacific Cod in the Bering Sea and Aleutian Islands Management Area, 8176-8177 2012-3397 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Documentation of Fish Harvest, 8217-8218 2012-3369 Atlantic Highly Migratory Species: Atlantic Shark Management Measures; 2012 Research Fishery, 8218-8219 2012-3423 Coastal Zone Management Program:

Illinois, 8219 2012-3362 Indirect Cost Rates for Office of National Marine Sanctuaries for Fiscal Years 2008 and 2009, 8219-8220 2012-2953 National Science National Science Foundation NOTICES Meetings: Astronomy and Astrophysics Advisory Committee, 8288 2012-3285 National Resources Natural Resources Conservation Service NOTICES Records of Decisions; Availability, etc.: Federal Highway Administration, Mississippi Department of Transportation Project FHWA-TN-EIS-04-01-F, 8215-8216 2012-3313 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Applications and Amendments to Facility Operating Licenses, etc., 8288-8296 2012-2865 Meetings;

Sunshine Act, 8296-8297 2012-3527 Patent Patent and Trademark Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 8220-8221 2012-3392 Pension Benefit Pension Benefit Guaranty Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Survey of Nonparticipating Single Premium Group Annuity Rates, 8297 2012-3417 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Delays in Processing of Special Permits Applications, 8326-8327 2012-2898 Presidential Documents Presidential Documents EXECUTIVE ORDERS Committees;

Establishment, Renewal, Termination, etc.: President's Global Development Council, Establishment (EO 13600), 8711-8715 2012-3616 Railroad Retirement Railroad Retirement Board PROPOSED RULES Restructuring of the Office of Programs; Elimination of Regional Offices, 8183-8184 2012-2808 Securities Securities and Exchange Commission RULES Reporting Line for the Commission's Inspector General, 8094-8095 2012-3312 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 8297-8304 2012-3335 2012-3336 2012-3337 2012-3338 2012-3339 2012-3340 Meetings;

Sunshine Act, 8304 2012-3478 Self-Regulatory Organizations; Proposed Rule Changes: BATS Exchange, Inc., 8310-8312, 8315-8318 2012-3331 2012-3332 Chicago Board Options Exchange, Inc., 8304-8307 2012-3328 Chicago Mercantile Exchange, Inc., 8318-8321 2012-3329 NASDAQ OMX BX, 8321-8322 2012-3330 NASDAQ OMX BX, Inc., 8307-8310 2012-3333 NASDAQ Stock Market LLC, 8312-8315 2012-3334 Social Social Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 8322-8324 2012-3291 State Department State Department RULES Visas:

Issuance of Full Validity L Visas to Qualified Applicants, 8119-8120 2012-3455 Surface Mining Surface Mining Reclamation and Enforcement Office RULES Texas Regulatory Program, 8144-8148 2012-3418 PROPOSED RULES Ohio Regulatory Program, 8185-8197 2012-3424 Susquehanna Susquehanna River Basin Commission RULES Review and Approval of Projects, 8095-8100 2012-2504 Tennessee Tennessee Valley Authority NOTICES Meetings; Sunshine Act, 8324 2012-3482 Textile Agreements Implementation Committee See Committee for the Implementation of Textile Agreements Transportation Department Transportation Department See Federal Aviation Administration See Federal Railroad Administration See Pipeline and Hazardous Materials Safety Administration NOTICES Meetings:

Applications for the Environment; Real-Time Information Synthesis User Needs Workshop, 8324 2012-3349 Treasury Treasury Department See Financial Crimes Enforcement Network See Internal Revenue Service Veteran Affairs Veterans Affairs Department NOTICES Meetings: Advisory Committee on Cemeteries and Memorials, 8330 2012-3327 Health Services Research and Development Service Scientific Merit Review Board, 8330 2012-3315 Separate Parts In This Issue Part II Commodity Futures Trading Commission, 8332-8447 2012-935 Part III Interior Department, Fish and Wildlife Service, 8450-8523 2012-2195 Part IV Energy Department, 8526-8574 2012-2784 Part V Environmental Protection Agency, 8576-8629 2012-2874 Part VI Interior Department, Fish and Wildlife Service, 8632-8665 2012-2940 Part VII Health and Human Services Department, 8668-8709 2012-3228 2012-3230 Labor Department, Employee Benefits Security Administration, 8668-8709 2012-3228 2012-3230 Treasury Department, Internal Revenue Service, 8668-8709 2012-3228 2012-3230 Part VIII Presidential Documents, 8711-8715 2012-3616 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. 77 30 Tuesday, February 14, 2012 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 [Document Number AMS-NOP-10-0079; NOP-09-02FR] RIN 0581-AD06 National Organic Program (NOP); 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)on May 22, 2008, November 19, 2008, and May 6, 2009. This final rule adds one substance, microcrystalline cheesewax, along with any restrictive annotations, for use in organic mushroom production; and adds three substances, acidified sodium chlorite, dried orange pulp, and Pacific kombu seaweed, with any restrictive annotations, for use in organic handling. This final rule also amends the annotation for one substance used in organic handling, unbleached lecithin, and removes bleached lecithin from the National List. DATES: *Effective Date:* This rule becomes effective March 15, 2012. FOR FURTHER INFORMATION CONTACT: Melissa Bailey, Ph.D., Director, Standards Division, National Organic Program, 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 synthetic, nonsynthetic nonagricultural 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 *et seq.* ), 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 NOP has published multiple 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); December 13, 2010 (75 FR 77521) and March 14, 2011 (76 FR 13501). Additionally, a proposed amendment to the National List was published on May 5, 2011 (76 FR 25612). This final rule amends the National list to enact six recommendations submitted to the Secretary by the NOSB on May 22, 2008, November 19, 2008, and May 6, 2009. 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 § 205.601 of the National List regulations by adding new paragraph

(o)for the addition of one substance as follows: As production aids. Microcrystalline cheesewax (CAS #s 64742- 42-3, 8009-03-08, and 8002-74-2)—for use in log grown mushroom production. Must be made without either ethylene-propylene co-polymer or synthetic colors. The proposed rule to add microcrystalline cheesewax included an annotation specifying that the substance be “for use in log grown mushroom culture.” The NOP determined that the substance's use annotation should be modified “for use in log grown mushroom *production”* (emphasis added) in this final rule. This language change is consistent with terminology that will be utilized in a forthcoming proposed rule on organic mushroom standards. 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 Groups(s))” This final rule amends § 205.605(b) of the National List regulations by removing Lecithin—bleached, and adding acidified sodium chlorite in alphabetical order as follows: Acidified sodium chlorite—Secondary direct antimicrobial food treatment and indirect food contact surface sanitizing. Acidified with citric acid 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 revising paragraph

(p)to read as follows:

(p)Lecithin—de-oiled. Further, this final rule redesignates paragraphs

(r)through

(t)and paragraphs

(u)through

(y)as paragraphs

(s)through

(u)and

(w)through

(aa)respectively; and adds new paragraphs

(r)and

(v)for the addition of two substances as follows:

(r)Orange pulp, dried, and

(v)Seaweed, Pacific kombu. 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 proposed rule were announced for NOSB deliberation in the following **Federal Register** notices:

(1)74 FR 11904, March 20, 2009 (bleached lecithin, acidified sodium chlorite, unbleached fluid lecithin);

(2)73 FR 54781, September 23, 2008 (dried orange pulp, acidified sodium chlorite); and

(3)73 FR 18491, April 4, 2008 (microcrystalline cheesewax, acidified sodium chlorite, Pacific kombu seaweed). The proposal to allow the use of the four substances in this final rule, along with the deletion of one substance and the revised annotation of one substance, was published as a proposed rule on November 8, 2010 (75 FR 68505). IV. 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 (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. 601-624), the Poultry Products Inspection Act (21 U.S.C. 451-471), or the Egg Products Inspection Act (21 U.S.C. 1031-1056), 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 effect of this final rule would be to allow the use of additional substances and clarify the use of one substance in agricultural production and handling. This action will modify the regulations published in the final rule and will provide small entities with more tools to use in day-to-day farming and handling operations. AMS concludes that the economic impact of this addition of allowed substances, if any, will be minimal and beneficial to small agricultural service firms. Accordingly, USDA certifies that this rule will not have a significant 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 upon 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 The AMS believes that most of these entities would be considered to be 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, 1992-200* 8. *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 grew from $3.6 billion in 1997 to nearly $21.1 billion in 2008. 3 Between 1990 and 2008, organic food sales demonstrated an historic growth rate between 15 to 24 percent each year. In 2010, organic food sales grew 7.7%. 4 3 Dimitri, C., and L. Oberholtzer. 2009. Marketing U.S. Organic Foods: Recent Trends from Farms to Consumers, Economic Information Information bulletin No. 58, U.S. Department of Agriculture, Economic Research Service, *http://www.ers.suda.gov/PublicationsE1B58.* 4 Organic Trade Association's *2011 Organic Industry Survey, http://www.ota.com.* In addition, USDA has 93 accredited certifying agents

(ACA)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 the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, Chapter 35. E. Executive Order 13175 This final rule has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation will not have substantial and direct effects on Tribal governments and will not have significant Tribal implications. F. Comments Received on Proposed Rule NOP-09-02 AMS received 11 comments on the proposed rule AMS-NOP-10-0079; NOP-09-02PR. Comments were received from specialty food ingredient processors and distributors, specialty food products manufacturers, an industrial sanitation supply firm, an organic consultant, a coalition of foreign governments and a private citizen. Comments were submitted in support of the proposed additions to the National List for all four of the proposed new use exemptions and the deletion of one substance. Comments in favor of the addition of acidified sodium chlorite to § 205.605(b) stated that it will increase the intervention options available for maintaining high sanitation standards in organic food processing and thereby further improve food safety for consumers of organic processed foods. While one comment expressed concern about the proposed exemption for the secondary direct antimicrobial food treatment use of acidified sodium chlorite, the commenter did not take a position for or against the specific proposal. A comment endorsing the addition of dried orange pulp to § 205.606 stated that its use is consistent with organic principles, since an insufficient volume of organic oranges are grown and processed to produce organic orange pulp, which is a byproduct of extraction orange juice processing. Many comments addressed the proposed change in the lecithin annotation from unbleached to de-oiled on § 205.606. Nonorganic forms of the substances listed under § 205.606 are allowed as ingredients in or on processed products labeled as organic only when the nonorganic substance is not commercially available in organic form and only in accordance with any specified restrictions. Most comments submitted in support of the lecithin annotation change stated that the listing of de-oiled lecithin on § 205.606 would prevent disruption in the availability or quality of a broad range of organic food products such as ice cream, pasta, bakery goods, cereals, sauces, soups and frozen desserts. They indicated that de-oiled is the appropriate annotation because this form of lecithin has a unique function and blander flavor in comparison to fluid or dry lecithin. The comments mentioned de-oiled lecithin's superiority in maintaining stability of water and oil emulsions. Furthermore, the comments informed that de-oiled lecithin is not available as organic. Comments in support of removing bleached lecithin from § 205.605(b) indicated that this action will encourage the increased production and use of organic ingredients needed for organic food processing. They also argued that unbleached lecithin is now commercially available in organic forms, so the exemption for these substances is no longer crucial. Commenters stated that the use of nonorganic de-oiled lecithin on § 205.606, instead of the nonorganic unbleached form previously allowed, would be subject to the determination of commercial availability of any organic form—once developed—in the processor's organic system plan and other specific restrictions. Commenters in favor of the amendment expressed frustration with discrepant use of organic unbleached lecithin and less expensive conventional unbleached lecithin in comparably priced multiple brands of the same processed organic products on retail shelves. These commenters conveyed expectations that this rule change will result in the replacement of nonorganic bleached lecithin with the organic form and thus encourage increased use and availability of organic ingredients. A few comments opposing the change in the unbleached lecithin annotation at § 205.606 explained that the only current source of organic lecithin is soy, which is a food allergen. They cited a lack of availability of organic forms of lecithin from sunflower or canola and predicted that consumers with a soy allergy would not be able to eat organic products containing soy lecithin. These commenters noted that soy is identified in the U.S. Food Allergen Labeling and Consumer Protection Act of 2004 (Pub. L. 108-282, Title II) (21 U.S.C. 301) as one of 8 major food groups which account for 90 percent of life-threatening food allergies. This legislation established mandatory disclosure requirements on labels for processed food containing any amounts of the eight named foods (milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans) listed in the 2004 Act. Food processors have become more aware of soy's allergenic potential and the federal labeling requirements when soy-based ingredients are used since passage of the 2004 Act. The opposing comments expressed concern that the annotation change would result in higher levels of soy lecithin being used in processed organic foods because it is more commonly available in organic form, but did not provide specific evidence to support this statement. Nonorganic lecithin from sunflower, rapeseed and canola is widely available commercially, and NOP believes that there is potential that any increased demand for non-soy lecithin will stimulate increased production of organic forms of bleached and unbleached lecithin from these alternative sources. A comment criticized the NOSB for omitting food allergies from the discussion in considering the lecithin petition. The NOSB did address this issue several times during its deliberation, as captured in the May 2009 NOSB meeting transcripts. The Board concluded that its recommended change to unbleached lecithin would still avail manufacturers with the option to use nonorganic, non-soy forms of de-oiled lecithin. Commenters conveyed a preference to have non-allergenic, nonorganic forms of lecithin available under § 205.606. The change in annotation does not specify the plant source of lecithin and, therefore, nonorganic de-oiled lecithin from non-soy and nonorganic sources may be used when organic equivalents are not available. A substance is considered commercially available if it is available in an appropriate form, quality, or quantity to fulfill an essential function in a system of organic production or handling, as determined by the certifying agent in the course of reviewing the organic plan. In summary, this annotation change would not limit the use of lecithin to organic de-oiled soy lecithin. Non-soy sources that are non-GMO and nonorganic would remain acceptable under § 205.606, and accredited certifying agents would continue to require any nonorganic de-oiled lecithin to be sourced from non-GMO sources as long as de-oiled lecithin is not commercially available in organic form. Changes Requested But Not Made Commenters requested that the proposed action be amended for § 205.606 to allow the use of non-GMO, non-allergenic lecithin. We have not made that change because we believe this request is mostly accommodated by the proposed action. Nonorganic forms of de-oiled lecithin can be used when the organic version is not commercially available. The NOP regulations define commercially available as a production input in an appropriate form, quality, or quantity to fulfill an essential function in a system of organic production or handling, as determined by the certifying agent in the course of reviewing the organic plan. Therefore, if a processor intends to make a soy-free product containing lecithin, in which de-oiled is the appropriate form, the processor may use nonorganic de-oiled lecithin from sunflower, canola or other sources if lecithin from the preferred sources is not available in organic form. If a product requires a form of lecithin other than de-oiled, such as fluid or powered, the lecithin must be sourced organically. The NOSB recommendation was finalized in May 2009. We believe that processors have had adequate notice to pursue the procurement of non-soy forms of organic lecithin if their products are intended to be soy free. 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. In § 205.601 add new paragraph

(o)to read as follows: § 205.601 Synthetic substances allowed for use in organic crop production.

(o)As production aids. Microcrystalline cheesewax (CAS #'s 64742-42-3, 8009-03-08, and 8002-74-2)-for use in log grown mushroom production. Must be made without either ethylene-propylene co-polymer or synthetic colors. 3. Section 205.605 is amended by: A. Removing “Lecithin-bleached” from paragraph (b); and B. Adding one new substance “Acidified sodium chlorite”, in alphabetical order, to paragraph

(b)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)).”

(b)* * * Acidified sodium chlorite—Secondary direct antimicrobial food treatment and indirect food contact surface sanitizing. Acidified with citric acid only. 4. Section 205.606 is amended by: A. Revising paragraph (p); B. Redesignating paragraphs

(r)through

(t)and paragraphs

(u)through

(y)as paragraphs

(s)through

(u)and

(w)through

(aa)respectively; and C. Adding new paragraphs

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

(p)Lecithin—de-oiled.

(r)Orange pulp, dried.

(v)Seaweed, Pacific kombu. Dated: February 3, 2012. Robert C. Keeney, Acting Administrator, Agricultural Marketing Service. [FR Doc. 2012-2938 Filed 2-13-12; 8:45 am]

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