Unknown. Final rule

5,096 words·~23 min read·/register/2011/08/03/2011-19659

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-2011-08-03.xml --- 76 149 Wednesday, August 3, 2011 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46809-46813 2011-19391 2011-19392 Agricultural Marketing Agricultural Marketing Service RULES National Organic Program; Sunset Review, 46595-46597 2011-19659 PROPOSED RULES Continuance Referenda: Sweet Cherries Grown in Designated Counties in Washington, 46651 2011-19654 Agriculture Agriculture Department See Agricultural Marketing Service See Forest Service Antitrust Division Antitrust Division NOTICES National Cooperative Research and Production Act of 1993:

Green Seal, Inc., 46843 2011-19443 Army Army Department NOTICES Privacy Act; Systems of Records, 46767-46768 2011-19640 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46813-46814 2011-19614 Centers Medicare Centers for Medicare & Medicaid Services PROPOSED RULES Medicaid and Children's Health Insurance Programs: Disallowance of Claims for FFP and Technical Corrections, 46684-46701 2011-19528 NOTICES Medicare Program:

Evaluation Criteria and Standards for Quality Improvement Program Contracts (10th Statement of Work), 46814-46818 2011-19650 Civil Rights Civil Rights Commission NOTICES Meetings: New Jersey Advisory Committee, 46723 2011-19668 Coast Guard Coast Guard RULES Safety Zones: Discovery World Private Wedding Firework Displays, Milwaukee, WI, 46626-46628 2011-19604 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46824-46828 2011-19608 2011-19609 2011-19610 Commerce Commerce Department See National Oceanic and Atmospheric Administration Consumer Product Consumer Product Safety Commission RULES Third Party Testing for Certain Children's Products;

Toys: Requirements for Accreditation, 46598-46603 2011-18962 Defense Department Defense Department See Army Department NOTICES 36(b)(1) Arms Sales, 46754-46756 2011-19557 Meetings: Military Family Readiness Council, 46756 2011-19553 Strategic Environmental Research and Development Program, Scientific Advisory Board, 46756 2011-19662 Privacy Act; Systems of Records, 46756-46757 2011-19613 Privacy Act; Systems of Records: Correction, 46757 2011-19552 Renewal of Department of Defense Federal Advisory Committees, 46757-46758 2011-19554 Revised Non-Foreign Overseas Per Diem Rates, 46758-46767 2011-19446 Drug Drug Enforcement Administration NOTICES Admonitions Of Registrants:

Terese, Inc., D/B/A/ Peach Orchard Drugs, 46843-46849 2011-19556 Education Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46768-46769 2011-19683 Applications for New Awards: Minority Science and Engineering Improvement Program, 46769-46774 2011-19686 Privacy Act; Systems of Records, 46774-46781 2011-19607 Employee Benefits Employee Benefits Security Administration RULES Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under Patient Protection and Affordable Care Act:

Amendment, 46621-46626 2011-19684 Employment and Training Employment and Training Administration NOTICES Amended Certifications Regarding Eligibility to Apply for Worker Adjustment Assistance: Hewlett Packard Co. et al., Boise, ID, 46854 2011-19578 International Business Machines Corp. et al., Armonk, NY, 46853-46854 2011-19579 JLG Industries, Inc. et al., McConnellsburg, PA and Hagerstown, MD, 46853 2011-19581 Leased Workers from Kelly Services, El Paso, TX, 46852 2011-19577 Panasonic Corp. of North America, Rolling Meadows, IL, 46852-46853 2011-19580 Negative Determinations on Reconsiderations:

Wausau Daily Herald, Wausau, WI, 46854-46855 2011-19582 Energy Department Energy Department See Energy Efficiency and Renewable Energy Office See Federal Energy Regulatory Commission Energy Efficiency Energy Efficiency and Renewable Energy Office NOTICES Meetings: Biomass Research and Development Technical Advisory Committee, 46781 2011-19649 Environmental Protection Environmental Protection Agency PROPOSED RULES Modifications of Significant New Uses: Tris carbamoyl triazine, 46678-46683 2011-19412 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 46794-46796 2011-19418 Butylate; Registration Review Proposed Decision; Availability, 46796-46798 2011-19691 Compatibility of Underground Storage Tank Systems with Biofuel Blends: Correction, 46798 2011-19682 Cross-Media Electronic Reporting: Authorized Program Revision Approvals, Commonwealth of Kentucky, 46798 2011-19696 Meetings: Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel, 46798-46801 2011-19527 Modifications of Expiration Dates for National Pollutant Discharge Elimination System General Permits:

Stormwater Discharges from Construction Activities on Tribal Lands within Southeastern United States, 46801-46804 2011-19687 Petitions and Tentative Affirmative Determinations: New York State Prohibition of Discharges of Vessel Sewage, 46804-46805 2011-19681 Utah Adoption by Reference of Pesticide Container Containment Rule, 46805 2011-19697 Equal Equal Employment Opportunity Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Uniform Guidelines on Employee Selection Procedures, 46805-46807 2011-19642 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives:

Bombardier, Inc. Model CL-600-2A12 (CL-601) and CL-600-2B16 (CL-601-3A, CL-601-3R, and CL-604 Variants) Airplanes, 46597-46598 C1--2011--17402 Federal Emergency Federal Emergency Management Agency PROPOSED RULES Flood Elevation Determinations, 46701-46715 2011-19546 2011-19549 Flood Elevation Determinations: Correction, 46715-46718 2011-19545 2011-19548 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Federal Assistance to Individuals and Households Programs, 46828-46829 2011-19541 Major Disaster Declarations:

Montana; Amendment No. 1, 46829-46830 2011-19542 Montana; Amendment No. 2, 46829 2011-19543 Federal Energy Federal Energy Regulatory Commission PROPOSED RULES Revision to Form No. 6, 46668-46671 2011-19652 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46781-46785 2011-19635 2011-19636 Applications Accepted for Filing and Soliciting Comments, Motions to Intervene, Protests, etc.: George Wenschhof, 46785-46786 2011-19625 Applications: Millennium Pipeline Co., LLC, 46786-46787 2011-19632 Combined Filings, 46787-46793 2011-19626 2011-19627 2011-19628 2011-19629 2011-19630 2011-19631 Environmental Assessments;

Availability, etc.: Jordan Hydroelectric Limited Partnership, 46793 2011-19637 Establishing Post-Technical Comment Periods: PJM Interconnection, L.L.C., PJM Power Providers Group v. PJM Interconnection, L.L.C., 46793 2011-19633 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: FFC Energy, LLC, 46793-46794 2011-19634 Federal Highway Federal Highway Administration NOTICES Final Federal Agency Actions on Proposed Highway in Alaska, 46889-46890 2011-19641 Final Federal Agency Actions on Proposed Highway in Washington, 46890-46891 2011-19558 Federal Railroad Federal Railroad Administration NOTICES Petitions for Waivers of Compliance:

West Texas and Lubbock Railway, 46891-46892 2011-19592 2011-19593 Federal Reserve Federal Reserve System PROPOSED RULES Retail Foreign Exchange Transactions, 46652-46668 2011-19535 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46807-46808 2011-19562 Proposals to Engage in, or to Acquire Companies Engaged in, Permissible Nonbanking Activities, 46808 2011-19606 Federal Transit Federal Transit Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 46892-46893 2011-19658 2011-19660 Fish Fish and Wildlife Service RULES Endangered and Threatened Wildlife and Plants: Removal of Echinacea tennesseensis (Tennessee Purple Coneflower) from the Federal List of Endangered and Threatened Plants, 46632-46650 2011-19674 Marine Mammals: Incidental Take During Specified Activities, 47010-47054 2011-19296 NOTICES Endangered and Threatened Species Permit Applications, 46837-46838 2011-19621 Food and Drug Food and Drug Administration PROPOSED RULES Food Labeling:

Gluten-Free Labeling of Foods; Reopening of Comment Period, 46671-46677 2011-19620 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation, etc., 46819 2011-19602 Guidance for Industry; Health Claim or Nutrient Content Claim Based on Authoritative Statement of Scientific Body, 46819-46820 2011-19601 Veterinary Feed Directive, 46818-46819 2011-19603 Proposals to Refuse to Approve Supplemental New Drug Applications:

Bromday (Bromfenac Ophthalmic Solution), 0.09; Opportunity for Hearing, 46820-46822 2011-19566 Foreign Assets Foreign Assets Control Office NOTICES Designation of Six Individuals Pursuant to Executive Order 13224, 46896-46897 2011-19643 Forest Forest Service NOTICES Environmental Impact Statements; Availability, etc.: Upper North Fork HFRA Ecosystem Restoration Project, Salmon-Challis National Forest, ID, 46721-46722 2011-19493 Meetings: Deschutes Provincial Advisory Committee, 46723 2011-19382 Southern New Mexico Resource Advisory Committee, 46722 2011-19616 Tuolumne-Mariposa Counties Resource Advisory Committee, 46722-46723 2011-19611 General Services General Services Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Sealed Bidding, 46808-46809 2011-19699 Health and Human Health and Human Services Department See Agency for Healthcare Research and Quality See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Food and Drug Administration See National Institutes of Health RULES Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under Patient Protection and Affordable Care Act:

Amendment, 46621-46626 2011-19684 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency See Transportation Security Administration PROPOSED RULES Ammonium Nitrate Security Program, 46908-46957 2011-19313 Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Displacement/Relocation/Temporary Relocation Assistance for Person, 46830-46831 2011-19574 Application for FHA Insured Mortgages, 46833-46834 2011-19590 Assessment of Native American, Alaska Native, and Native Hawaiian Housing Needs, 46832 2011-19587 Funding Availability for Transformation Initiative;

Sustainable Construction in Indian Country Grant Program, 46834-46835 2011-19586 Loan Guarantee Recovery Fund, 46832-46833 2011-19591 Loan Sales Bidder Qualification Statement, 46835 2011-19584 Manufactured Housing Installation Program Reporting Requirements, 46836-46837 2011-19583 Mortgagor's Certification of Actual Cost, 46831-46832 2011-19585 Use Restriction Agreement Monitoring and Compliance, 46835-46836 2011-19575 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See National Park Service See Reclamation Bureau See Surface Mining Reclamation and Enforcement Office Internal Revenue Internal Revenue Service RULES Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under Patient Protection and Affordable Care Act:

Amendment, 46621-46626 2011-19684 PROPOSED RULES Indoor Tanning Services; Cosmetic Services Excise Taxes: Public Hearing, 46677 2011-19597 Requirements for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under Patient Protection and Affordable Care Act, 46677-46678 2011-19685 NOTICES Meetings: Taxpayer Advocacy Panel Small Business/Self Employed Correspondence Exam Practitioner Engagement Project Committee, 46897 2011-19680 Taxpayer Advocacy Panel Small Business/Self Employed Correspondence Exam Toll Free Project Committee, 46897 2011-19679 Quarterly Publication of Individuals Who have Chosen to Expatriate, 46898-46905 2011-19677 International Trade Com International Trade Commission NOTICES Investigations;

Commission Decisions Not to Review Initial Determinations: Certain Products Containing Interactive Program Guides and Parental Controls Technology, 46841-46842 2011-19571 Justice Department Justice Department See Antitrust Division See Drug Enforcement Administration See National Institute of Corrections NOTICES Lodgings of Consent Decrees: U.S. v. Dow Chemical Co., 46842-46843 2011-19657 U.S. v. Wilko Paint, Inc., 46842 2011-19589 Labor Department Labor Department See Employee Benefits Security Administration See Employment and Training Administration Land Land Management Bureau NOTICES Meetings:

Coos Bay District Resource Advisory Committee, 46838 2011-19615 Proposed Class II Reinstatements of Terminated Oil and Gas Leases: Utah, 46838 2011-19656 Proposed Reinstatements of Terminated Oil and Gas Leases: NDM 95192, 46839 2011-19653 Maritime Maritime Administration NOTICES Requested Administrative Waivers of Coastwise Trade Laws, 46893-46895 2011-19598 2011-19599 2011-19600 National Archives National Archives and Records Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 46855-46856 2011-19619 National Highway National Highway Traffic Safety Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Reports, Forms and Record Keeping Requirements, 46895-46896 2011-19594 National Institute Corrections National Institute of Corrections NOTICES Solicitations for Cooperative Agreements: Curriculum Development for Women Offenders; Developing Agency-wide Approach, 46849-46852 2011-19561 National Institute National Institutes of Health NOTICES Meetings:

Center for Scientific Review, 46822, 46824 2011-19688 2011-19695 National Eye Institute, 46822-46823 2011-19700 National Institute of Environmental Health Sciences, 46823-46824 2011-19693 National Institute on Aging, 46823 2011-19698 National Oceanic National Oceanic and Atmospheric Administration PROPOSED RULES Fisheries of Caribbean, Gulf of Mexico, and South Atlantic: Snapper-Grouper Fishery Off Southern Atlantic States; Control Date for Commercial Wreckfish Sector, 46718-46719 2011-19667 Western Pacific Bottomfish and Seamount Groundfish Fisheries: 2011-12 Main Hawaiian Islands Deep 7 Bottomfish Annual Catch Limits and Accountability Measures, 46719-46720 2011-19665 NOTICES Evaluations and Final Findings;

Availability: State Coastal Management Programs and National Estuarine Research Reserves, 46723-46724 2011-19494 Takes of Marine Mammals Incidental to Specified Activities: Seabird and Pinniped Research Activities in Central California, 2011-2012, 46724-46729 2011-19666 Shallow Hazards Survey in Chukchi Sea, AK, 46729-46753 2011-19663 Taking and Importing Marine Mammals: Taking Marine Mammals Incidental to Coastal Commercial Fireworks Displays at Monterey Bay National Marine Sanctuary, CA, 46753-46754 2011-19664 National Park National Park Service NOTICES National Register of Historic Places:

Pending Nominations and Related Actions, 46839-46840 2011-19572 Nuclear Regulatory Nuclear Regulatory Commission PROPOSED RULES Petitions for Rulemaking: California Association of Marriage and Family Therapists, 46651-46652 2011-19639 NOTICES Qualification of Connection Assemblies for Nuclear Power Plants, 46856 2011-19638 Postal Regulatory Postal Regulatory Commission NOTICES Mail Classification Schedule Changes, 46856-46857 2011-19669 Post Office Closings, 46857-46858 2011-19576 Reclamation Reclamation Bureau NOTICES Time Extension to Accept Proposals, Select One Lessee, and Contract for Hydroelectric Power Development:

Pueblo Dam River Outlet, Fryingpan-Arkansas Project (Fry-Ark Project), Colorado, 46840 2011-19617 Securities Securities and Exchange Commission RULES Large Trader Reporting, 46960-47007 2011-19419 Security Ratings, 46603-46621 2011-19421 PROPOSED RULES Business Conduct Standards for Security-Based Swap Dealers and Major Security-Based Swap Participants, 46668 C1--2011--16758 NOTICES Self-Regulatory Organizations; Proposed Rule Changes: Chicago Stock Exchange, Inc., 46866-46867 2011-19690 Financial Industry Regulatory Authority, Inc., 46870-46889 2011-19645 NASDAQ OMX BX, Inc., 46858-46860 2011-19563 NASDAQ Stock Market LLC, 46869-46870 2011-19612 New York Stock Exchange LLC, 46860-46863 2011-19647 NYSE Amex LLC, 46863-46865 2011-19646 Options Clearing Corp., 46867-46869 2011-19564 State Department State Department NOTICES U.S.

Advisory Panel to U.S. Section of North Pacific Anadromous Fish Commission; Charter Renewal, 46889 2011-19655 Surface Mining Surface Mining Reclamation and Enforcement Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46840-46841 2011-19386 2011-19389 Surface Transportation Surface Transportation Board RULES Regulations Governing Fees for Services Performed in Connection with Licensing and Related Services-2011 Update, 46628-46632 2011-19416 NOTICES Senior Executive Service Performance Review Board, 46896 2011-19605 Transportation Department Transportation Department See Federal Aviation Administration See Federal Highway Administration See Federal Railroad Administration See Federal Transit Administration See Maritime Administration See National Highway Traffic Safety Administration See Surface Transportation Board See Transportation Security Administration Security Transportation Security Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Secure Flight Program, 46830 2011-19569 Treasury Treasury Department See Foreign Assets Control Office See Internal Revenue Service Separate Parts In This Issue Part II Homeland Security Department, 46908-46957 2011-19313 Part III Securities and Exchange Commission, 46960-47007 2011-19419 Part IV Interior Department, Fish and Wildlife Service, 47010-47054 2011-19296 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. 76 149 Wednesday, August 3, 2011 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 [Document Number AMS-TM-07-0136; TM-07-14FR] RIN 0581-AC77 National Organic Program (NOP); Sunset Review

(2011)AGENCY: Agricultural Marketing Service, USDA. ACTION: Final rule. SUMMARY: This final rule addresses recommendations submitted to the Secretary of Agriculture (Secretary) by the National Organic Standards Board

(NOSB)on November 5, 2009, and April 29, 2010. The recommendations addressed in this final rule pertain to the continued exemption

(use)of 12 substances in organic production and handling. Consistent with the recommendations from the NOSB, this final rule continues the exemption

(use)of 12 substances (along with any restrictive annotations) on the U.S. Department of Agriculture's

(USDA)National List of Allowed and Prohibited Substances (National List). DATES: *Effective Date:* This final rule becomes effective September 12, 2011. FOR FURTHER INFORMATION CONTACT: Melissa Bailey, PhD, Director, Standards Division, *Telephone:*

(202)720-3252; *Fax:*

(202)205-7808. SUPPLEMENTARY INFORMATION: I. Background The Organic Foods Production Act of 1990 (OFPA), 7 U.S.C. 6501 *et seq.,* authorizes the establishment of the National List of Allowed and Prohibited Substances (National List). The National List identifies synthetic substances that may be used in organic production and nonsynthetic (natural) substances that are prohibited in organic crop and livestock production. The National List also identifies nonagricultural nonsynthetic, nonagricultural synthetic and nonorganic agricultural substances that may be used in organic handling. The exemptions and prohibitions granted under the OFPA are required to be reviewed every 5 years by the National Organic Standards Board (NOSB). The Secretary of Agriculture has authority under the OFPA to renew such exemptions and prohibitions. If they are not reviewed by the NOSB within 5 years of their inclusion on the National List and renewed by the Secretary, their authorized use or prohibition expires. This means that synthetic substances Hydrogen chloride (CAS # 7647-01-0) and Ferric phosphate (CAS # 10045-86-0), currently allowed for use in organic crop production, will no longer be allowed for use after the sunset date, September 12, 2011. This also means that Egg white lysozyme (CAS # 9001-63-2), L-Malic acid (CAS # 97-67-6), Microorganisms, Activated charcoal (CAS #s 7440-44-0; 64365-11-3), Cyclohexylamine (CAS # 108-91-8), Diethylaminoethanol (CAS # 100-37-8), Octadecylamine (CAS # 124-30-1), Peracetic acid/Peroxyacetic acid (CAS # 79-21-0), Sodium acid pyrophosphate (CAS # 7758-16-9), and Tetrasodium pyrophosphate (CAS # 7722-88-5), currently allowed for use in organic handling, will no longer be allowed for use after the sunset date, September 12, 2011. This final rule reflects recommendations submitted to the Secretary by the NOSB concerning the continued use of 12 substances on the National List in organic production and handling. Consistent with the recommendations from the NOSB, this final rule renews 12 exemptions on the National List (along with any restrictive annotations). Under the authority of the OFPA, as amended (7 U.S.C. 6501 *et seq.* ), the National List can be amended by the Secretary based on recommendations 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), and a final rule affirming a previous amendment was published on March 14, 2011 (76 FR 13504). II. Overview of Renewals The following provides an overview of the renewals for designated sections of the National List regulations: Renewals This final rule continues the exemptions at § 205.601, along with any restrictive annotations for the following synthetic substances allowed for use in organic crop production: Ferric phosphate (CAS # 10045-86-0); and Hydrogen chloride (CAS # 7647-01-0). This final rule continues the exemptions at § 205.605(a), along with any restrictive annotations, for the following nonsynthetic, nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food groups(s))”: Egg white lysozyme (CAS # 9001-63-2); L-Malic acid (CAS # 97-67-6); and Microorganisms. This final rule continues the exemptions at § 205.605(b), along with any restrictive annotations, for the following synthetic, nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food groups(s))”: Activated charcoal (CAS #s 7440-44-0; 64365-11-3); Cyclohexylamine (CAS # 108-91-8); Diethylaminoethanol (CAS # 100-37-8); Octadecylamine (CAS # 124-30-1); Peracetic acid/Peroxyacetic acid (CAS # 79-21-0); Sodium acid pyrophosphate (CAS # 7758-16-9); and Tetrasodium pyrophosphate (CAS # 7722-88-5). Nonrenewals The NOSB determined that a continuing need was demonstrated for the authorization of the 12 exemptions. In addition, most comments received on the proposed rule (76 FR 2880) supported renewal of all 12 exemptions. Accordingly, there are no nonrenewals. III. Related Documents One advanced notice of proposed rulemaking with request for comments was published in the **Federal Register** on March 14, 2008 (73 FR 13795), to make the public aware that the allowance for 12 synthetic and nonsynthetic substances in organic production and handling will expire, if not reviewed by the NOSB and renewed by the Secretary. The proposed rule for this final rule was published in the **Federal Register** on January 4, 2011 (76 FR 288). IV. Statutory and Regulatory Authority The OFPA, as amended (7 U.S.C. 6501 *et seq.* ), 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 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/AMSv1.0/.* 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. 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 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 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 continued use of additional substances in agricultural production and handling. 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 NOP, 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 historically demonstrated a 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 Bulletin No. 58, U.S. Department of Agriculture, Economic Research Service, *http://www.ers.usda.gov/Publications/EIB58.* 4 Organic Trade Association's *2011 Organic Industry Survey, http://www.ota.com.* In addition, USDA has 94 accredited certifying agents who provide 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 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 § 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. E. Comments Received on Proposed Rule AMS-TM-07-0136 AMS received nine comments on proposed rule AMS-TM-07-0136. Comments were received from an organic producer, trade associations, handlers, and private citizens. Most comments expressed positions in support of the 12 substances considered under this sunset review. One individual did not refer to subjects within the scope of this rulemaking. Some commenters specifically supported substances that they promote, represent, or rely on. A comment submitted in support of Ferric phosphate emphasized the importance of the substance to reduce snail damage on organic crops. A comment received on Hydrogen chloride voiced that there are no good alternatives to the use of the substance for removal of residual lint from ginned cottonseed, a process necessary to facilitate mechanical planting. A comment received on Egg white lysozyme stated that the substance is essential for organic wine production. A comment submitted in support of L-Malic acid underscored that no alternatives exist for this substance and stated its importance as a processing aid for pH adjustment in organic products. Multiple comments received on Microorganisms emphasized the critical need for microorganisms in organic food processing for production of dairy, bread, fruit, vegetable, and meat products. Comments received in support of the allowance for Activated charcoal confirmed the necessity of this substance as a filtering aid in organic processing. Comments submitted supporting the allowance for the substances Cyclohexylamine, Diethylaminoethanol, and Octadecylamine, all boiler water additives, stated that these substances are important for packaging sterilization. Comments supporting the use of Peracetic acid/Peroxyacetic acid for sanitizing food contact surfaces indicated that there are no alternative materials with equivalent functionality. One comment submitted in support of Sodium acid pyrophosphate stated that without the allowance for this substance as a leavening agent, many organic baked goods would no longer be available because a satisfactory alternative does not exist. The same commenter also emphasized the necessity of Tetrasodium pyrophosphate in the manufacturing of meat analog products to facilitate proper flow in the extrusion process and ensure the development of suitable product texture. Overall, at least one comment was received in favor of renewal for all 12 substances considered under this sunset review. Changes Requested But Not Made One commenter opposed the continued use of six of the 12 substances: Cyclohexylamine, Diethylaminoethanol, Octadecylamine, Peracetic acid/Peroxyacetic acid, Sodium acid pyrophosphate, and Tetrasodium pyrophosphate. The commenter based their objection on the safety of the substances as described in the material safety data sheets

(MSDS)for each substance and recommended removal of these substances from the National List. However, the NOSB reviewed these substances against the evaluation criteria in 7 U.S.C. 6517 and 6518 of the OFPA, and found that when these substances are used as limited by the annotations for each substance, they do not pose any danger to the environment or to manufacturing personnel or consumers. The NOSB concluded that these substances remain essential to organic production since no organic alternatives exist and recommended that the exemption for these substances on the National List continue. The NOP concurs with the NOSB's evaluation and recommendation of these substances and, therefore, does not find that sufficient information was provided by the commenter to justify the removal of these substances from the National List. F. Effective Date This final rule reflects recommendations submitted to the Secretary by the NOSB for the purpose of fulfilling the requirements of 7 U.S.C. 6517(e) of the OFPA. Section 7 U.S.C. 6517(e) requires the NOSB to review each substance on the National List within 5 years of its publication. The substances being reauthorized for use on the National List were initially authorized for use in organic agriculture on September 12, 2006. Because these substances are critical to organic production and handling operations, producers and handlers should be able to continue to use these substances for a full 5-year period beyond their expiration date of September 12, 2011. Accordingly, pursuant to 5 U.S.C. 553, it is found and determined that good cause exists for not postponing the effective date of this rule until 30 days after publication in the **Federal Register** . This rule shall be effective on September 12, 2011. 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. The authority citation for 7 CFR part 205 continues to read as follows: Authority: 7 U.S.C. 6501-6522. Dated: July 28, 2011. David R. Shipman, Acting Administrator, Agricultural Marketing Service. [FR Doc. 2011-19659 Filed 8-2-11; 8:45 am]

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