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Code · REGISTER · 2008-02-25 · PROPOSED RULES · Agricultural Agricultural Marketing Service PROPOSED RULES Continuance Referendum: Tart Cherries Grown in Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin, 9965 E8-3494 NOTICE · Unknown

Unknown. Final rule

40,504 words·~184 min read·/register/2008/02/25/08-823

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-2008-02-25.xml --- 73 37 Monday, February 25, 2008 Contents Agricultural Agricultural Marketing Service PROPOSED RULES Continuance Referendum: Tart Cherries Grown in Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin, 9965 E8-3494 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 9984-9985 E8-3496 Agriculture Agriculture Department See Agricultural Marketing Service See Forest Service NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 9984 E8-3495 Antitrust Antitrust Division NOTICES Cooperative Research Group on Clean Diesel V, 10064-10065 08-806 National Cooperative Research Notifications: Global Climate and Energy Project, 10065 08-805 Institute of Electrical and Electronics Engineers, 10065 08-802 LiMo Foundation, 10065 08-803 PXI Systems Alliance, Inc., 10066 08-804 Census Census Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 9988-9989 E8-3504 E8-3505 Coast Guard Coast Guard NOTICES Chemical Transportation Advisory Committee;
Vacancies, 10041-10042 E8-3412 Notification of the Imposition of Conditions of Entry for Certain Vessels Arriving to the United States; Indonesia, 10042-10043 08-842 Commerce Commerce Department See Census Bureau See Industry and Security Bureau See International Trade Administration See National Oceanic and Atmospheric Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 9987-9988 E8-3503 Commodity Commodity Futures Trading Commission NOTICES Meetings;
Sunshine Act, 10006 08-844 08-847 08-849 Defense Defense Department RULES Financial Assistance to Local Educational Agencies, 9949-9950 E8-3479 NOTICES Federal Acquisition Regulation: Information Collection; Commerce Patent Regulations, 10006-10007 E8-3558 Information Collection; Make-or-Buy Program, 10007-10008 E8-3560 Drug Drug Enforcement Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 10066 E8-3471 Education Education Department NOTICES Meetings:
National Committee on Foreign Medical Education and Accreditation, 10008 E8-3469 Personnel Development to Improve Services and Results for Children with Disabilities Program, 10008-10009 E8-3520 Energy Energy Department See Federal Energy Regulatory Commission EPA Environmental Protection Agency NOTICES Announcement of Availability and Comment Period: Revised Enforcement and Compliance and Tribal Identifier Data Standards, 10026 E8-3497 FAA Federal Aviation Administration RULES Standard Instrument Approach Procedures;
Miscellaneous Amendments, 9937-9938 E8-2862 Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments, 9935-9937 E8-2861 PROPOSED RULES Airworthiness Directives: Apex Aircraft Model CAP 10 B Airplanes, 9968-9970 E8-3411 Dornier Luftfahrt GmbH Models 228-100, 228-101, 228-200, 228-201, 228-202, and 228-212 Airplanes, 9965-9967 E8-3407 General Electric Company CF6-80C2 and CF6-80E1 Series Turbofan Engines, 9970-9971 E8-3463 NOTICES Public notice for a Change in Use of Aeronautical Property:
St. Marys Municipal Airport, St. Marys, PA, 10087-10088 E8-3528 FCC Federal Communications Commission RULES Creation of a Low Power Radio Service; Correction, 9954-9955 E8-3533 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 10026-10029 E8-3345 E8-3523 E8-3537 Meetings: Advisory Committee on Diversity for Communications in the Digital Age, 10029 08-839 William F. Crowell, Application to Renew License for Amateur Radio Service Station W6WBJ, 10029-10030 E8-3346 FDIC Federal Deposit Insurance Corporation NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 10030-10032 E8-3377 Federal Energy Federal Energy Regulatory Commission NOTICES Application Accepted for Filing and Soliciting Comments, Motions to Intervene, and Protests: Arkansas River Hydro 5, LLC, 10010-10011 E8-3438 David Terry Hydro, LLC, 10011-10012 E8-3440 Emmett Sanders Hydro, LLC, 10012-10013 E8-3439 Hydro Green Energy, LLC, 10013-10014 E8-3499 Kentucky Hydro 3, LLC, 10014-10015 E8-3441 Kiamichi Hydro, LLC, 10009-10010, 10016-10018 E8-3355 E8-3500 Toad Suck Ferry Hydro, LLC, 10015-10016 E8-3437 Availability of Environmental Assessment:
James Lichoulas, Jr., 10018 E8-3501 Combined Notice of Filings, 10018-10023 E8-3359 E8-3434 E8-3506 Filing: Bangor Hydro-Electric Co., et al., 10023 E8-3435 Intent to File License Application and Request to Use Alternative Licensing Procedures: East Texas Electric Cooperative, Inc., 10023-10024 E8-3436 ISO New England Inc.; Technical Conference, 10024 E8-3502 Out of Time Informational Filing; Enstor Grama Ridge Storage and Transportation LLC: Enstor Grama Ridge Storage and Transportation LLC, 10024-10025 E8-3498 Petition for Declaratory Order:
White Cliffs Pipeline, L.L.C., 10025 E8-3442 Technical Conference: ISO New England Inc., 10025 E8-3357 Federal Motor Federal Motor Carrier Safety Administration NOTICES Availability of Commercial Driver's License Information System (CDLIS) Modernization Grant Funds, 10088 E8-3413 Federal Reserve Federal Reserve System NOTICES Formations, Acquisitions, and Mergers of Bank Holding Companies, 10032 E8-3458 FTC Federal Trade Commission NOTICES Negotiated Data Solutions LLC; Analysis of Proposed Consent Order to Aid Public Comment, 10032-10033 E8-3556 Federal Transit Federal Transit Administration NOTICES National Transit Database:
Amendments to Safety & Security Reporting Manual, 10089-10090 E8-3517 Supplemental Draft Environmental Impact Statement for the Central Corridor Light Rail Transit Project: Minneapolis and Saint Paul, Minnesota, 10090-10092 E8-3525 Fish Fish and Wildlife Service PROPOSED RULES Importation, Exportation, and Transportation of Wildlife; Inspection Fees, Import/Export Licenses, and Import/Export License Exemptions, 9972-9983 E8-3330 NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 10048-10049 E8-3464 Safe Harbor Agreement for Serpentine Endemic Species Located on Tulare Hill in Santa Clara County, California, 10049-10050 E8-3420 Food Food and Drug Administration RULES Food Labeling: Health Claims; Soluble Fiber From Certain Foods and Risk of Coronary Heart Disease, 9938-9947 E8-3418 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 10033-10035 E8-3415 Combe, Inc.; Filing of Color Additive Petition, 10035 E8-3416 Guidance for Industry:
Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products; Availability, 10035-10036 E8-3487 Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables; Availability, 10037-10038 E8-3417 Forest Forest Service NOTICES Shasta-Trinity National Forest, California, 9985-9987 08-800 GSA General Services Administration NOTICES Federal Acquisition Regulation: Information Collection;
Commerce Patent Regulations, 10006-10007 E8-3558 Information Collection; Make-or-Buy Program, 10007-10008 E8-3560 Geological Geological Survey NOTICES Meetings: Advisory Committee on Water Information; Correction, 10099 C8-613 Health Health and Human Services Department See Food and Drug Administration See National Institutes of Health Homeland Homeland Security Department See Coast Guard See Transportation Security Administration Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 10044-10046 E8-3524 E8-3526 Computer Matching Program Between HUD and HHS: Matching Tenant Data in Assisted Housing Programs, 10046-10048 E8-3516 Industry Industry and Security Bureau NOTICES Export Privileges, Actions Affecting: Fazeli, Mohammad, 9989-9990 08-826 Interior Interior Department See Fish and Wildlife Service See Geological Survey See Land Management Bureau See National Park Service See Reclamation Bureau NOTICES Outer Continental Shelf
(OCS)Scientific Committee-Notice of Renewal, 10048 E8-3519 IRS Internal Revenue Service PROPOSED RULES Consolidated Returns; Intercompany Obligations, 08-822 9971-9972 08-823 NOTICES Recruitment Notice for the Taxpayer Advocacy Panel, 10096 E8-3425 International International Trade Administration NOTICES Chlorinated Isocyanurates from the People's Republic of China: Extension of Time Limit for the Preliminary Results of the Antidumping Duty Administrative Review, 9990 E8-3529 Export Trade Certificate of Review, 9990-9993 E8-3426 E8-3478 Final Results of Countervailing Duty New Shipper Review: Certain In-shell Roasted Pistachios from the Islamic Republic of Iran, 9993-9994 E8-3511 Initiation of Countervailing Duty Investigation: Circular Welded Austenitic Stainless Pressure Pipe from the People's Republic of China, 9994-9997 E8-3510 Lightweight Thermal Paper from Germany and the People's Republic of China: Postponement of Preliminary Determinations of Antidumping Duty Investigations, 9997-9998 E8-3534 Malleable Cast Iron Pipe Fittings from the People's Republic of China: Rescission of Antidumping Duty Administrative Review, 9998 E8-3532 Preliminary Affirmative Countervailing Duty Determination and Alignment of Final Countervailing: Raw Flexible Magnets from the People's Republic of China, 9998-10003 E8-3493 International International Trade Commission NOTICES Termination of Five-Year Reviews: Sulfanilic Acid from Hungary and Portugal, 10064 E8-3443 Justice Justice Department See Antitrust Division See Drug Enforcement Administration RULES Privacy Act; Systems of Records, 9947-9949 E8-3433 Labor Labor Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 10067 E8-3445 Land Land Management Bureau NOTICES Filing of Plats of Survey; Oregon/Washington, 10050-10051 E8-3473 NASA National Aeronautics and Space Administration NOTICES Federal Acquisition Regulation: Information Collection; Commerce Patent Regulations, 10006-10007 E8-3558 Information Collection; Make-or-Buy Program, 10007-10008 E8-3560 National Environmental Policy Act; Space Shuttle Program, 10067-10068 E8-3405 National Highway National Highway Traffic Safety Administration RULES Civil Penalties, 9955-9957 E8-3518 NIH National Institutes of Health NOTICES Meetings: National Institute of Diabetes and Digestive and Kidney Diseases, 08-815 10038-10040 08-819 National Institute on Aging, 10038 08-816 National Institute on Drug Abuse, 10038-10039 08-817 National Library of Medicine, 10040 08-818 Scientific Review Center, 10040-10041 08-814 08-820 NOAA National Oceanic and Atmospheric Administration RULES Fisheries off West Coast States and in the Western Pacific: Amendment 15 to the Pacific Coast Salmon Fishery Management Plan, 9960-9964 E8-3348 Fisheries of the Northeastern United States: Atlantic Bluefish Fisheries— 2008 Atlantic Bluefish Specifications, 9957-9960 E8-3514 Summer Flounder, Scup, and Black Sea Bass Fisheries; 2008 Scup Specifications— Correction, 9957 E8-3522 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, E8-3507 10003-10005 E8-3508 E8-3509 Meetings: National Sea Grant Review Panel, 10005 E8-3521 North Pacific Fishery Management Council, 10005 E8-3429 U.S. Climate Change Science Program Synthesis and Assessment Product Draft: Coastal Elevation and Sensitivity to Sea Level Rise, 10005-10006 E8-3513 National Park National Park Service NOTICES Intent to Repatriate a Cultural Item: Alaska State Museum, Juneau, AK, 10051 E8-3457 Intent to Repatriate Cultural Items: Arizona State Museum, University of Arizona, Tucson, AZ, 10051-10052 E8-3453 Inventory Completion: Arizona State Museum, University of Arizona, Tucson, AZ, 10052-10053 E8-3459 Channel Islands National Park, Ventura, CA and Fowler Museum at UCLA, Los Angeles, CA, 10053 E8-3449 Denver Museum of Nature & Science, Denver, CO, E8-3455 10054-10055 E8-3456 Natural History Museum of Los Angeles County Foundation, Los Angeles, CA; Correction, 10055-10059 E8-3447 E8-3450 E8-3451 Oregon State University Department of Anthropology, Corvallis, OR, 10059 E8-3448 Pioneer Historical Society of Bent County, Las Animas, CO, 10060 E8-3454 Southeast Archeological Center, Tallahassee, FL, 10060-10061 E8-3446 Utah Museum of Natural History, University of Utah, Salt Lake City, UT, 10061-10062 E8-3452 National Register of Historic Places: Notification of Pending Nominations and Related Actions, 10062-10063 E8-3428 Nuclear Nuclear Regulatory Commission NOTICES Entergy Nuclear Operations, Inc.; Indian Point Nuclear Generating Unit Nos. 2 and 3; Action Request Receipt, 10068-10069 E8-3472 Environmental Assessment: South Carolina Electric & Gas Co., 10069-10071 E8-3486 Pension Pension Benefit Guaranty Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 10071-10073 E8-3410 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Hazardous Materials: Special Permit Applications; List, 10092-10093 08-812 Special Permit Modification Applications; List, 10093-10094 08-813 Railroad Railroad Retirement Board NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, E8-3468 10074-10075 E8-3474 E8-3475 Reclamation Reclamation Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 10063-10064 E8-3466 Saint Lawrence Saint Lawrence Seaway Development Corporation RULES Seaway Regulations and Rules: Periodic Update, Various Categories, 9950-9954 E8-3323 SEC Securities and Exchange Commission PROPOSED RULES Exemption from Registration for Foreign Private Issuers, 10102-10122 E8-3424 NOTICES Self-Regulatory Organizations; Proposed Rule Changes: Boston Stock Exchange, Inc., 10075-10076 E8-3444 Chicago Board Options Exchange, Inc., 10076-10080 E8-3432 NASDAQ Stock Market LLC, E8-3430 10080-10084 E8-3431 NYSE Arca, Inc., 10084-10086 E8-3465 Surface Surface Transportation Board NOTICES Abandonment Exemption, etc.: Union Railroad Company and Norfolk Southern Railway Company; Allegheny County, PA, 10094 E8-3477 Arizona Eastern Railway; Construction and Operation Exemption, Graham County, Arizona, 10094-10095 E8-3480 TVA Tennessee Valley Authority NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 10086-10087 E8-3427 Meetings: TVA Regional Resource Stewardship Council, 10087 08-799 Transportation Transportation Department See Federal Aviation Administration See Federal Motor Carrier Safety Administration See Federal Transit Administration See National Highway Traffic Safety Administration See Pipeline and Hazardous Materials Safety Administration See Saint Lawrence Seaway Development Corporation See Surface Transportation Board Transportation Transportation Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 10043-10044 E8-3467 Transportation Worker Identification Credential: Enrollment Dates for the Ports of Marine City, MI; St. Ignace, MI; Palm Beach, FL; and St. Louis, MO, 10044 E8-3527 Treasury Treasury Department See Internal Revenue Service See United States Mint NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, E8-3421 10095-10096 E8-3422 MISSING FOR: U.S.-China Economic and Security Review Commission U.S.-China Economic and Security Review Commission NOTICES Hearings, 10097 E8-3419 U.S. Mint United States Mint NOTICES Meetings: Citizens Coinage Advisory Committee, 10096-10097 E8-3476 Veterans Veterans Affairs Department NOTICES Meetings: Voluntary Services National Advisory Committee, 10097-10098 08-811 VA Property for the Development and Operation of a Transitional Housing Facility for Homeless Veterans: Batavia, NY, 10098 E8-3414 Separate Parts In This Issue Part II Securities and Exchange Commission, 10102-10122 E8-3424 Reader Aids Consult the Reader Aids section at the end of this issue 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. 73 37 Monday, February 25, 2008 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 97 [Docket No. 30593; Amdt. No. 3256] Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This Rule establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports. DATES: This rule is effective February 25, 2008. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of February 25, 2008. ADDRESSES: Availability of matters incorporated by reference in the amendment is as follows: *For Examination* — 1. FAA Rules Docket, FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; 2. The FAA Regional Office of the region in which the affected airport is located; 3. The National Flight Procedures Office, 6500 South MacArthur Blvd., Oklahoma City, OK 73169; or 4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html* . *Availability* —All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit *http://nfdc.faa.gov* to register. Additionally, individual SIAP and Takeoff Minimums and ODP copies may be obtained from: 1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; or 2. The FAA Regional Office of the region in which the affected airport is located. FOR FURTHER INFORMATION CONTACT: Harry J. Hodges, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125) telephone:
(405)954-4164. SUPPLEMENTARY INFORMATION: This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or revoking SIAPs, Takeoff Minimums and/or ODPs. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The applicable FAA Forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A. The large number of SIAPs, Takeoff Minimums and ODPs, in addition to their complex nature and the need for a special format make publication in the **Federal Register** expensive and impractical. Furthermore, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA forms is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs and the effective dates of the SIAPs, the associated Takeoff Minimums, and ODPs. This amendment also identifies the airport and its location, the procedure, and the amendment number. The Rule This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as contained in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center
(FDC)Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided. Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure before adopting these SIAPs, Takeoff Minimums and ODPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs effective in less than 30 days. Conclusion The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866;
(2)is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and
(3)does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR part 97 Air Traffic Control, Airports, Incorporation by reference, and Navigation (Air). Issued in Washington, DC on Febuary 8, 2008. James J. Ballough, Director, Flight Standards Service. Adoption of the Amendment Accordingly, pursuant to the authority delegated to me, under Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or revoking Standard Instrument Approach Procedures and/or Takeoff Minimums and/or Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows: PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES 1. The authority citation for part 97 continues to read as follows: Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722. 2. Part 97 is amended to read as follows: Effective 13 MAR 2008 Spokane, WA, Felts Field, RNAV (GPS)-A, Orig-A Effective 10 APR 2008 Tuscaloosa, AL, Tuscaloosa Regional, RNAV
(GPS)RWY 4, Orig Tuscaloosa, AL, Tuscaloosa Regional, RNAV
(GPS)RWY 11, Orig Tuscaloosa, AL, Tuscaloosa Regional, RNAV
(GPS)RWY 22, Orig Tuscaloosa, AL, Tuscaloosa Regional, RNAV
(GPS)RWY 29, Orig Tuscaloosa, AL, Tuscaloosa Regional, GPS RWY 4, Orig-C, CANCELLED Tuscaloosa, AL, Tuscaloosa Regional, GPS RWY 22, Orig-C, CANCELLED Hope, AR, Hope Muni, RNAV
(GPS)RWY 4, Orig, CANCELLED Hope, AR, Hope Muni, VOR/DME RWY 4, Amdt 8, CANCELLED Globe, AZ, San Carlos Apache, Takeoff Minimums and Obstacle DP, Amdt 2 Bishop, CA, Eastern Sierra Rgnl, RNAV
(GPS)Y RWY 12, Orig Bishop, CA, Eastern Sierra Rgnl, RNAV
(GPS)Z RWY 12, Orig Borrego Springs, CA, Borrego Valley, Takeoff Minimums and Obstacle DP, Amdt 2 Los Angeles, CA, Los Angeles Intl, ILS OR LOC RWY 24L, Amdt 24B Los Angeles, CA, Los Angeles Intl, ILS OR LOC RWY 24R; ILS RWY 24R (CAT II); ILS RWY 24R, CAT III), Amdt 23B Los Angeles, CA, Los Angeles Intl, RNAV
(GPS)RWY 24L, Orig-A Los Angeles, CA, Los Angeles Intl, RNAV
(GPS)RWY 24R, Orig-A Palm Springs, CA, Palm Springs Intl, Takeoff Minimums and Obstacle DP, Amdt 5 Sacramento, CA, McClellan Airfield, Takeoff Minimums and Obstacle DP, Amdt 1 Tracy, CA, Tracy Muni, NDB RWY 25, Orig, CANCELLED Salida, CO, Harriet Alexander Field, RNAV (GPS)-A, Orig Salida, CO, Harriet Alexander Field, Takeoff Minimums and Obstacle DP, Orig Lanai City, HI, Lanai, ILS OR LOC RWY 3, Orig-A Harrisburg, IL, Harrisburg-Raleigh, RNAV
(GPS)RWY 6, Orig Harrisburg, IL, Harrisburg-Raleigh, RNAV
(GPS)RWY 24, Amdt 1 Harrisburg, IL, Harrisburg-Raleigh, Takeoff Minimums and Obstacle DP, Orig Oakland, MD, Garrett County, RNAV
(GPS)RWY 9, Orig Oakland, MD, Garrett County, RNAV
(GPS)RWY 27, Orig Oakland, MD, Garrett County, Takeoff Minimums and Obstacle DP, Orig Austin, MN, Austin Muni, ILS OR LOC RWY 35, Orig Austin, MN, Austin Muni, RNAV
(GPS)RWY 35, Orig Cloquet, MN, Cloquet Carlton County, RNAV
(GPS)RWY 35, Orig Cloquet, MN, Cloquet Carlton County, NDB RWY 35, Amdt 4 Marshall, MN, Southwest Minnesota Regional Marshall/Ryan Fld, ILS OR LOC RWY 12, Amdt 2 Marshall, MN, Southwest Minnesota Regional Marshall/Ryan Fld, RNAV
(GPS)RWY 12, Orig Marshall, MN, Southwest Minnesota Regional Marshall/Ryan Fld, VOR RWY 12, Amdt 8 Marshall, MN, Southwest Minnesota Regional Marshall/Ryan Fld, Takeoff Minimums and Obstacle DP, Amdt 2 Billings, MT, Billings Logan Intl, Takeoff Minimums and Obstacle DP, Amdt 5 Syracuse, NY, Syracuse Hancock Intl, ILS OR LOC RWY 10, Amdt 12 Wilson, NC, Wilson Industrial Air Center, RNAV
(GPS)RWY 3, Amdt 1 Wilson, NC, Wilson-Industrial Air Center, RNAV
(GPS)RWY 9, Amdt 1 Wilson, NC, Wilson-Industrial Air Center, RNAV
(GPS)RWY 15, Amdt 1 El Reno, OK, El Reno Regional, RNAV
(GPS)RWY 17, Orig El Reno, OK, El Reno Regional, RNAV
(GPS)RWY 35, Orig El Reno, OK, El Reno Regional, VOR/DME RWY 35, Amdt 2 El Reno, OK, El Reno Regional, Takeoff Minimums and Obstacle DP, Orig Woodward, OK, West Woodward, NDB RWY 17, Amdt 3, CANCELLED Clarion, PA, Clarion County, RNAV
(GPS)RWY 6, Amdt 1 Clarion, PA, Clarion County, RNAV
(GPS)RWY 24, Amdt 1 Grove City, PA, Grove City, VOR-A, Amdt 6 Grove City, PA, Grove City, VOR/DME RNAV OR GPS RWY 10, Amdt 2, CANCELLED Grove City, PA, Grove City, VOR/DME RNAV OR GPS RWY 28, Amdt 2, CANCELLED Grove City, PA, Grove City, RNAV
(GPS)RWY 10, Orig Grove City, PA, Grove City, RNAV
(GPS)RWY 28, Orig Charleston, SC, Charleston AFB/Intl, ILS OR LOC RWY 33, Amdt 6 Charleston, SC, Charleston AFB/Intl, ILS OR LOC RWY 15, Amdt 22, ILS RWY 15 (CAT II) St George, SC, St George, RNAV
(GPS)RWY 5, Orig St George, SC, St George, VOR/DME-A, Amdt 2 St George, SC, St George, Takeoff Minimums and Obstacle DP, Orig Milbank, SD, Milbank Municipal, Takeoff Minimums and Obstacle DP, Orig Corpus Christi, TX, Corpus Christi Intl, LOC RWY 31, Amdt 7 Corpus Christi, TX, Corpus Christi Intl, Takeoff Minimums and Obstacle DP, Amdt 1 Laredo, TX, Laredo Intl, VOR OR TACAN RWY 32, Amdt 10A Tooele, UT, Bolinder Field-Tooele Valley, ILS OR LOC/DME RWY 17, Orig Tooele, UT, Bolinder Field-Tooele Valley, RNAV
(GPS)RWY 17, Amdt 1 Deer Park, WA, Deer Park, RNAV
(GPS)RWY 34, Orig Deer Park, WA, Deer Park, NDB-A, Amdt 2 Charleston, WV, Yeager, ILS OR LOC RWY 5, Amdt 6 Janesville, WI, Southern Wisconsin Regional, ILS OR LOC RWY 32, Amdt 1 Janesville, WI, Southern Wisconsin Regional, Takeoff Minimums and Obstacle DP, Orig Effective 05 JUN 2008 Glendale, AZ, Glendale Muni, RNAV
(GPS)RWY 1, Orig-A Oakland, CA, Metropolitan Oakland Intl, ILS OR LOC RWY 11, Amdt 5A Willows, CA, Willows-Glenn County, VOR RWY 34, Amdt 5, CANCELLED Quakertown, PA, Quakertown, VOR RWY 29, Amdt 1, CANCELLED Effective 31 JUL 2008 Chico, CA, Chico Muni, VOR RWY 13L, Amdt 9B, CANCELLED Eureka, CA, Murray Field, VOR/DME RNAV RWY 11, Amdt 6A, CANCELLED The FAA published an Amendment in Docket No. 30589, Amdt No. 3253 to Part 97 of the Federal Aviation Regulations (Vol 73, FR No. 16, Page 4073 dated Thursday, January 24, 2008) under section 97.33, effective March 13, 2008, which is hereby rescinded as follows: Seattle, WA, Boeing Field/King County Intl, RNAV
(GPS)Z RWY 13R, Orig-A The FAA published an Amendment in Docket No. 30591, Amdt No. 3254 to Part 97 of the Federal Aviation Regulations (Vol 73, FR No. 27, Page 7463 dated Friday, February 08, 2008) under section 97.29 effective February 14, 2008, which is hereby corrected to read as follows: Omaha, NE, Eppley Airfield, ILS OR LOC RWY 32L, Amdt 1 Omaha, NE, Eppley Airfield, ILS OR LOC/DME RWY 14L, Amdt 1 Omaha, NE, Eppley Airfield, ILS OR LOC/DME RWY 14R, ILS RWY 14R (CAT II), ILS RWY 14R (CAT III), Amdt 4 Omaha, NE, Eppley Airfield, RNAV
(GPS)RWY 14L, Amdt 1 Omaha, NE, Eppley Airfield, Takeoff Minimums and Obstacle DP, Amdt 5 [FR Doc. E8-2861 Filed 2-22-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 97 [Docket No. 30594; Amdt. No. 3257] Standard Instrument Approach Procedures; Miscellaneous Amendments AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This rule amends Standard Instrument Approach Procedures (SIAPs) for operations at certain airports. These regulatory actions are needed because of changes in the National Airspace System, such as the commissioning of new navigational facilities, adding of new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports. DATES: This rule is effective February 25, 2008. The compliance date for each SIAP is specified in the amendatory provisions. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of February 25, 2008. ADDRESSES: Availability of matter incorporated by reference in the amendment is as follows: *For Examination* — 1. FAA Rules Docket, FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; 2. The FAA Regional Office of the region in which the affected airport is located; 3. The National Flight Procedures Office, 6500 South MacArthur Blvd., Oklahoma City, OK 73169; or 4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html* . *Availability* —All SIAPs are available online free of charge. Visit *http://nfdc.faa.gov* to register. Additionally, individual SIAP and Takeoff Minimums and ODP copies may be obtained from: 1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; or 2. The FAA Regional Office of the region in which the affected airport is located. FOR FURTHER INFORMATION CONTACT: Harry J. Hodges, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125), telephone:
(405)954-4164. SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of Title 14 of the Code of Federal Regulations. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the **Federal Register** expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAP and the corresponding effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number. The Rule This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP as modified by FDC/P-NOTAMs. The SIAPs, as modified by FDC P-NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for all these SIAP amendments requires making them effective in less than 30 days. Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making these SIAPs effective in less than 30 days. Conclusion The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866;
(2)is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and
(3)does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR Part 97 Air Traffic Control, Airports, Incorporation by reference, and Navigation (Air). Issued in Washington, DC on Febuary 8, 2008. James J. Ballough, Director, Flight Standards Service. Adoption of the Amendment Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97, 14 CFR part 97, is amended by amending Standard Instrument Approach Procedures, effective at 0901 UTC on the dates specified, as follows: PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES 1. The authority citation for part 97 continues to read as follows: Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722. 2. Part 97 is amended to read as follows: *§§ 97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 97.35 [Amended] * By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, ISMLS, MLS/DME, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, identified as follows: Effective Upon Publication FDC date State City Airport FDC No. Subject 01/31/08 VA DUBLIN NEW RIVER VALLEY 8/3193 ILS RWY 6, AMDT 4 02/01/08 NE OMAHA EPPLEY AIRFIELD 8/3311 ILS OR LOC RWY 32L, AMDT 1 02/01/08 OH DAYTON DAYTON INTL 8/3324 ILS OR LOC RWY 24R, AMDT 7 02/06/08 ME MILLINOCKET MILLINOCKET MUNI 8/3814 LOC RWY 29, ORIG-B 02/06/08 ME MILLINOCKET MILLINOCKET MUNI 8/3815 VOR OR GPS-A, AMDT 10A 02/06/08 ME MILLINOCKET MILLINOCKET MUNI 8/3816 NDB OR GPS RWY 29, AMDT 3A 02/05/08 CO DENVER DENVER INTL 8/3609 ILS RWY 25, AMDT 2 02/01/08 IL CHICAGO CHICAGO O'HARE INTL 8/3306 ILS OR LOC RWY 9R, AMDT 8 02/05/08 IL CHICAGO CHICAGO O'HARE INTL 8/3591 ILS OR LOC RWY 4R, AMDT 6G 02/04/08 FL ORLANDO EXECUTIVE 8/3524 VOR/DME RWY 25, AMDT 2A 02/04/08 FL ORLANDO EXECUTIVE 8/3525 RNAV
(GPS)RWY 25, ORIG-A 02/04/08 FL ORLANDO EXECUTIVE 8/3526 LOC BC RWY 25, AMDT 21A [FR Doc. E8-2862 Filed 2-22-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2008-P-0090] (formerly Docket No. 2006P-0393) Food Labeling: Health Claims; Soluble Fiber From Certain Foods and Risk of Coronary Heart Disease AGENCY: Food and Drug Administration, HHS. ACTION: Interim final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending the health claim regulation entitled “Soluble fiber from certain foods and risk of coronary heart disease (CHD)” to add barley betafiber as an additional eligible source of beta-glucan soluble fiber. Barley betafiber is the ethanol precipitated soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain barley flour. FDA is taking this action in response to a health claim petition submitted by Cargill, Inc. FDA previously concluded that there was significant scientific agreement that a claim characterizing the relationship between beta-glucan soluble fiber of certain whole oat and whole grain barley products and CHD risk is supported by the totality of publicly available scientific evidence. Based on the totality of publicly available scientific evidence, FDA now has concluded that in addition to certain whole oat and whole grain barley products, barley betafiber is also an appropriate source of beta-glucan soluble fiber. Therefore, FDA is amending the health claim regulation entitled “Soluble fiber from certain foods and risk of CHD” to include barley betafiber as another eligible source of beta-glucan soluble fiber. DATES: This interim final rule is effective February 25, 2008. Submit written or electronic comments by May 12, 2008. ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-P-0090 (formerly Docket No. 2006P-0393), by any of the following methods: *Electronic Submissions* Submit electronic comments in the following way: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. *Written Submissions* Submit written submissions in the following ways: • FAX: 301-827-6870. • Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal, as described previously, in the ADDRESSES portion of this document under *Electronic Submissions* . *Instructions* : All submissions received must include the agency name and Docket No(s). and Regulatory Information Number
(RIN)(if a RIN number has been assigned) for this rulemaking. All comments received may be posted without change to *http://www.regulations.gov* , including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. *Docket* : For access to the docket to read background documents or comments received, go to *http://www.regulations.gov* and insert the docket number(s), found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Jillonne Kevala, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1450. SUPPLEMENTARY INFORMATION: I. Background A. The Nutrition Labeling and Education Act of 1990 The Nutrition Labeling and Education Act of 1990 (the 1990 amendments) (Public Law 101-535) amended the Federal Food, Drug, and Cosmetic Act (the act) in a number of important ways. One aspect of the 1990 amendments was that they clarified FDA's authority to regulate health claims on food labels and in food labeling. FDA
(we)issued several new regulations in 1993 that implemented the health claim provisions of the 1990 amendments. Among these were 21 CFR 101.14, *Health claims: general requirements* (58 FR 2478, January 6, 1993) and § 101.70 (21 CFR 101.70), *Petitions for health claims* (58 FR 2478), which set out the general requirements for the authorization and use of health claims and established a process for petitioning the agency to authorize health claims about substance-disease relationships and set out the types of information that any such petition must include. These regulations became effective on May 8, 1993. When implementing the 1990 amendments, FDA also conducted a review of evidence for a relationship between dietary fiber and cardiovascular disease (CVD). Based on this review, the agency concluded that the available scientific evidence did not justify authorization of a health claim relating dietary fiber to reduced risk of CVD (58 FR 2552, January 6, 1993) (1993 dietary fiber and CVD health claim final rule). However, FDA did conclude there was significant scientific agreement that the totality of publicly available scientific evidence supported an association between types of foods that are low in saturated fat and cholesterol and that naturally are good sources of soluble dietary fiber (i.e., fruits, vegetables, and grain products) and reduced risk of CHD 1 . Therefore, FDA authorized a health claim about the relationship between diets low in saturated fat and cholesterol and high in vegetables, fruit, and grain products that contain soluble fiber and a reduced risk of CHD (21 CFR 101.77; 58 FR 2552 at 2572). In the 1993 dietary fiber and CVD health claim final rule, FDA commented that if a manufacturer could document with appropriate evidence that consumption of the type of soluble fiber in a particular food has the effect of lowering blood low density lipoprotein
(LDL)cholesterol, and has no adverse effects on other heart disease risk factors (e.g., high density lipoprotein cholesterol), it should petition for authorization of a health claim specific for that particular dietary fiber-containing food (58 FR 2552 at 2567). 1 Cardiovascular disease means diseases of the heart and circulatory system. Coronary heart disease, one form of cardiovascular disease, refers to diseases of the heart muscle and supporting blood vessels. B. Soluble Fiber from Certain Foods and Risk of CHD Health Claim (21 CFR 101.81) In 1995, FDA received a petition for a health claim on the relationship between oat bran and rolled oats and reduced risk of CHD. FDA concluded there was significant scientific agreement that the totality of publicly available scientific evidence supported the relationship between consumption of whole oat products and reduced risk of CHD. FDA further concluded that the type of soluble fiber found in whole oats, i.e., beta-glucan soluble fiber, is the component primarily responsible for the hypocholesterolemic effects associated with consumption of whole oat foods as part of a diet that is low in saturated fat and cholesterol (62 FR 3584 at 3597 and 3598, January 23, 1997). As such, the final rule authorized a health claim relating the consumption of beta-glucan soluble fiber in whole oat foods, as part of a diet low in saturated fat and cholesterol, and reduced risk of CHD (the 1997 oat beta-glucan health claim final rule). The source of beta-glucan soluble fiber in foods bearing this health claim had to be one of three eligible whole oat products; i.e., oat bran, rolled oats, or whole oat flour (see § 101.81(c)(2)(ii)(A)). In the 1997 oat beta-glucan health claim final rule, FDA anticipated the likelihood that other sources and types of soluble fibers could also affect blood lipid levels, and thus, may reduce heart disease risk (62 FR 3584 at 3587). At that time, FDA considered structuring the final rule as an umbrella regulation authorizing the use of a claim for “soluble fiber from certain foods“ and risk of CHD. Such action would have allowed flexibility in expanding the claim to other specific food sources of soluble fiber when consumption of those foods has been demonstrated to help reduce the risk of heart disease. However, the agency concluded that it was premature to do so because FDA had not reviewed the totality of evidence on other, non-whole oat sources of soluble fiber (62 FR 3584 at 3588). The agency amended § 101.81 (21 CFR 101.81), in response to a health claim petition to add a health claim relating soluble fiber from psyllium seed husk and CHD risk (63 FR 8103, February 18, 1998). At this time, FDA also modified the heading in § 101.81 from “* * * Soluble fiber from whole oats and risk of coronary heart disease” to “* * * Soluble fiber from certain foods and risk of coronary heart disease (CHD)” (63 FR 8103). FDA has also amended § 101.81, in response to health claim petitions, to include oatrim, whole grain barley, and certain dry milled barley grain products as eligible sources of beta-glucan soluble fiber. In 2002, FDA amended § 101.81 to add oatrim, which is the soluble fraction of alpha-amylase hydrolyzed oat bran or whole oat flour, as an eligible source of beta-glucan soluble fiber (67 FR 61733, October 2, 2002), and finally, FDA amended § 101.81 to add whole grain barley and certain dry milled barley grain products as eligible sources of beta-glucan soluble fiber in 2005 (70 FR 76150, December 23, 2005). II. Petition and Grounds A. The Petition Cargill, Inc. (petitioner), submitted a health claim petition to FDA on June 20, 2006, under section 403(r)(4) of the act (21 U.S.C. 343(r)(4)). The petition requested that the agency expand the “Soluble fiber from certain foods and risk of coronary heart disease health claim” (§ 101.81) to include “barley betafiber” (described in section II.B of this document) as an eligible food ingredient source of beta-glucan soluble fiber in addition to the oat and whole grain and dry milled barley ingredients now listed (Ref. 1). On September 28, 2006, the agency notified the petitioner that it had completed its initial review of the petition and that the petition was being filed for further action in accordance with section 403(r)(4) of the act. If the agency does not act, by either denying the petition or issuing a proposed regulation to authorize the health claim, within 90 days of the date of filing for further action, the petition is deemed to be denied unless an extension is mutually agreed upon by the agency and the petitioner (section 403(r)(4)(A)(i) of the act and § 101.70(j)(3)(iii)). The petitioner and FDA subsequently mutually agreed to extend the deadline for the agency's decision on the petition to March 6, 2008. The petitioner also requested that FDA issue an interim final rule by which labeling of foods that contain “barley betafiber” in appropriate amounts could bear the health claim prior to publication of a final rule. B. Nature of the Substance The substance that is the subject of the oat/barley portion of current § 101.81 is beta-glucan soluble fiber from the specific oat and barley food products listed in § 101.81(c)(2)(ii)(A). Current § 101.81(c)(2)(ii)(A) has been amended twice previously to list additional oat or barley food products as eligible sources (67 FR 61773 and 70 FR 76150). Similar to these previous actions, FDA is now, in response to Cargill's health claim petition, amending § 101.81(c)(2)(ii)(A) to list barley betafiber as an eligible source of barley beta-glucan soluble fiber. The petition states that barley betafiber is a concentrated barley beta-glucan soluble fiber product derived from whole barley flour. The petitioner's description of the barley betafiber manufacturing process reflects information contained in the petitioner's patent entitled “ *Improved Dietary Fiber Containing Materials Comprising Low Molecular Weight Glucan* ” ( *World Intellectual Property Organization, International* Publication Number WO 2004/086878 A2) (Ref. 2) and a report of an expert panel on the generally recognized as safe
(GRAS)status of barley betafiber commissioned by the petitioner (Ref. 3). The patent and the GRAS status report provide information on multiple variations of procedures for manufacturing concentrated barley beta-glucan soluble fiber products; these procedures differ from the manufacturing procedures for producing the unique barley betafiber substance that is the subject of the petition. Further, the clinical trial reported in the petition tested two different barley beta-glucan soluble fiber concentrates—a high molecular weight concentrate and a low molecular weight concentrate. The petitioner specified that the barley betafiber product, which is the subject of the petition, is only the low molecular weight concentrate studied in the clinical trial (Ref. 4). FDA was not satisfied that the information in the petition was sufficiently specific in describing the manufacturing process for the unique barley betafiber product for which there is scientific evidence to permit a showing that the product is comparable in cholesterol-lowering ability to the other oat and barley food products listed in current § 101.81(c)(2)(ii)(A). Discussion between the agency and the petitioner resulted in the description of the barley betafiber manufacturing process presented in the following paragraph and in final § 101.81(c)(2)(ii)(A)( *6* ) (Refs. 2 through 5). Barley betafiber is produced from an aqueous slurry of whole grain barley flour, starting with addition of an exogenous grain liquefying enzyme preparation with cellulase and alpha-amylase activity, derived from *Bacillus amyloliquefaciens* . The cellulase activity of the enzyme preparation acts on the beta-glucan soluble fiber in barley flour, since beta-glucan is a type of cellulose, and the alpha-amylase activity of the enzyme preparation acts on the starch in the barley flour. The temperature of the slurry is kept at or above the gelatinization temperature of the barley starch but below cellulase enzyme inactivation temperature; i.e., about 65° C, for about 30 to 60 minutes, to facilitate a partial hydrolysis of both the beta-glucan soluble fiber and starch. The pH of the slurry is kept in the range of about 5 to 7. When the cellulase enzymatic hydrolysis of barley flour has modified the beta-glucan soluble fiber to the desired extent, the cellulase activity of the enzyme preparation is heat inactivated. After the cellulase activity of the enzyme preparation has been deactivated, an exogenous thermo-stable amylolytic enzyme is added to the barley flour slurry for continued hydrolysis of starch molecules at the higher temperature. The slurry is held at the higher temperature until substantially all the starch has been hydrolyzed. A clear aqueous extract, which contains barley betafiber and the sugars and dextrins resulting from substantial hydrolysis of starch is then separated from insoluble material by centrifugation. Barley betafiber is precipitated from the aqueous extract supernatant with ethanol to separate it from other soluble components (i.e., substantially hydrolyzed starch, protein, lipids and other minor components) that remain suspended in the aqueous extract supernatant. The resultant barley betafiber precipitate is then dried and milled. The molecular weight range of barley betafiber produced by this procedure is 120 to 400 kilodaltons (Refs. 2, 3, and 5). The molecular weight range of barley betafiber is substantially reduced from that of native barley beta-glucan soluble fiber. The molecular weight range of native barley beta-glucan soluble fiber has been reported to range from about 500 to 3,330 kilodaltons depending upon the cultivars and applied extraction procedures, although lower molecular weight values of 80 to 300 kilodaltons have also been reported (Ref. 1). In final § 101.81(c)(2)(ii)(A)( *6* ), FDA defines barley betafiber by its manufacturing process, as follows “ *Barley betafiber* . Barley betafiber is the ethanol precipitated soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain barley. Barley betafiber is produced by hydrolysis of whole grain barley flour, as defined in paragraph (c)(2)(ii)(A)( *5* ) of this section, with a cellulase and alpha-amylase enzyme preparation, to produce a clear aqueous extract that contains mainly partially hydrolyzed beta-glucan and substantially hydrolyzed starch. The soluble, partially hydrolyzed beta-glucan is separated from the insoluble material by centrifugation, and after removal of the insoluble material, the partially hydrolyzed beta-glucan soluble fiber is separated from the other soluble compounds by precipitation with ethanol. The product is then dried, milled and sifted. Barley betafiber shall have a beta-glucan soluble fiber content of at least 70 percent on a dry weight basis.” C. Review of Preliminary Requirements for a Health Claim 1. The Substance Is Associated With a Disease for Which the U.S. Population Is at Risk CHD continues to be a disease that has a large impact on mortality and morbidity in the general adult U.S. population. As explained in the existing beta-glucan soluble fiber health claim (§ 101.81(b)), FDA recognizes the CHD risk reduction benefit of certain foods that are sources of soluble dietary fiber resulting from effects on lowering blood total and LDL cholesterol. Although age-adjusted CHD mortality rates in the United States had been steadily decreasing since approximately 1960, recent evidence has suggested that the decline in CHD mortality has slowed (Ref. 6). Heart disease has been recognized as the leading cause of death in the United States for at least the last 50 years (Ref. 6). Based on these facts, FDA concludes that, as required in § 101.14(b)(1), CHD is a disease for which the U.S. population is at risk. 2. The Substance Is a Food The substance of the health claim is beta-glucan soluble fiber from listed oat and barley sources. The petitioner requests an amendment to add barley betafiber to the list of eligible sources of beta-glucan soluble fiber. Barley betafiber is derived from whole barley flour. Barley flour is a commonly consumed human food and beta-glucan soluble fiber is a nutrient component of this food. Thus, the beta-glucan soluble fiber from barley betafiber, a processed whole barley flour product, is a “substance” as defined in § 101.14(a)(2). Health claim general requirements provide that where a substance is to be consumed at “other than decreased dietary levels,” the substance must contribute taste, aroma, nutritive value, or any other technical effect as listed in 21 CFR 170.3(o), and must retain that attribute when consumed at levels necessary to justify the claim (§ 101.14(b)(3)(i)). The level necessary to justify the claim is 0.75 g beta-glucan soluble fiber per serving. The term “nutritive value” is defined in § 101.14(a)(3) as “a value in sustaining human existence by such processes as promoting growth, replacing lost essential nutrients, or providing energy.” The petitioner provided several examples of food categories (bars, beverages, bread, breakfast cereals, cookies, crackers, instant rice, pasta, muffins, salad dressings, snack chips, soups, tortillas and taco shells, vegetarian patties/crumbles, and reduced fat yogurt) in which barley betafiber could be used as an ingredient at a maximum level of 3 grams
(g)beta-glucan soluble fiber per serving. Beta-glucan soluble fiber at 0.75 to 3 g per serving contributes nutritive value because it provides a source of calories and soluble fiber. In addition to its role as a source of beta-glucan soluble fiber, barley betafiber also has technical effects, including food applications as a thickener (e.g., soups), texturizer (e.g., snack foods), humectant (e.g., retain moisture of tortillas), or fat replacer (e.g., dressings for salads). Therefore, FDA concludes that the preliminary requirement of § 101.14(b)(3)(i) is satisfied. 3. The Substance Is Safe and Lawful Section 101.14(b)(3)(ii) requires that the substance be a food or a food ingredient or a component of a food ingredient whose use at the levels necessary to justify a claim has been demonstrated by the proponent of the claim, to FDA's satisfaction, to be safe and lawful under the applicable food safety provisions of the act. The petitioner asserts that the use of barley betafiber as a food ingredient is GRAS. The petitioner included in its health claim petition documentation of its 2003 GRAS self-determination for barley betafiber, which contains 70 percent or more pure barley beta-glucan soluble fiber as evidence that barley betafiber meets the safe and lawful requirement (Ref. 3). FDA also received a notice informing FDA that the petitioner determined, through scientific procedures, that the use of barley betafiber is GRAS. FDA issued a letter (Ref. 7) in response to this notice stating that the agency had no questions at the time regarding petitioner's conclusions that barley betafiber is GRAS under the intended conditions of use. The 2003 Cargill GRAS self-determination stipulates that barley betafiber is obtained from food-grade whole grain barley flour by water extraction at elevated temperature, while starch is removed during the extraction process by treatment with enzymes that are GRAS for use in food manufacturing processes, specifically alpha-amylases from *Bacillus licheniformis* and *B. amyloliquefaciens* . The extracted barley betafiber is recovered by precipitation with denatured ethanol suitable for food production, and contains 70 percent or more beta-glucan, 2 to 12 percent protein, and less than 3 percent of each sugars, lipids, and inorganic salts. The basis of the safety determination relies on the fact that barley betafiber contains only native components of barley and is formed by the action of applied food-grade enzymes, residues, or processing aids. In addition, barley is a traditional food with a long history of safe use, since at least 8,000 B.C. based on archeological discoveries (Ref. 3). In the Maghreb countries of Morocco, Algeria, Libya, and Tunisia, barley is used in a variety of traditional foods (bread, soup, porridge), resulting in an average intake of up to 172 g per person per day (Morocco). With this intake of barley, about 6 g per person per day of pure beta-glucan soluble fiber is consumed. The preparation of these traditional foods involves baking or boiling for longer periods of time, which ensures extraction of beta-glucan from its natural context (cell walls, complexes with proteoglycans). The physiological properties of beta-glucan as a dietary fiber may, therefore, be found in these traditional foods as is intended to be achieved with the addition to processed foods of barley beta-glucan concentrate. The intended uses of barley betafiber listed as a food ingredient stated in the 2003 Cargill GRAS self-determination include the following food categories: Bars, beverages, bread (whole grain and specialty), breakfast cereals (ready to eat and cooked), cookies (lite), crackers (reduced fat), instant rice, macaroni products, muffins (reduced fat), salad dressings (lite), snack chips (reduced fat), soups, tortillas and taco shells, vegetarian patties/crumbles, and reduced fat yogurt. The maximum incorporation rate for each of these food applications is 3 g beta-glucan soluble fiber from barley betafiber per serving. FDA concludes that the petitioners have satisfied the preliminary requirement of § 101.14(b)(3)(ii) to demonstrate, to FDA's satisfaction, that the use of beta-glucan soluble fiber from barley betafiber at levels necessary to justify the health claim is safe and lawful under the applicable food safety provisions of the act. The agency has not made its own determination regarding the GRAS status of barley betafiber or beta-glucan soluble fiber from barley betafiber. Furthermore, the agency notes that a regulation to authorize a health claim for a substance should not be interpreted as affirmation that the substance is GRAS. III. Review of Scientific Evidence of the Substance-Disease Relationship A. Basis for Evaluating the Relationship Between Beta-Glucan Soluble Fiber from Barley Betafiber and CHD The types of data that FDA has recognized in previous CHD health claim evaluations as useful for assessing CHD risk reduction are: Coronary events (myocardial infarction, ischemia), cardiovascular death, atherosclerosis, high blood pressure, serum total cholesterol, and serum LDL cholesterol. FDA considers high blood pressure, serum total cholesterol, and serum LDL cholesterol levels to be the only currently validated surrogate measures for CHD risk (Ref. 8). Elevated levels of serum total and LDL cholesterol, a prerequisite for atherosclerotic disease, is a major modifiable risk factor in the development of CHD (Ref. 8). For these reasons, the agency based its original evaluation of the relationship between oat beta-glucan soluble fiber and CHD risk (62 FR 3584) and subsequent evaluations to add oatrim (67 FR 61773) and barley as eligible sources of beta-glucan soluble fiber (70 FR 76150) in the health claim, primarily on evidence for serum total and LDL cholesterol-lowering effects of beta-glucan soluble fiber containing food ingredients. As such, our evaluation of the evidence supporting the petitioned request to extend the eligible barley sources to include barley betafiber (as described in section II.B of this preamble), focused on evidence from human randomized controlled trials of the effects of consuming beta-glucan soluble fiber from barley betafiber on blood lipids. This focus is consistent with existing § 101.81 in which FDA concluded that there is significant scientific agreement that the relationship between CHD risk and consumption of beta-glucan soluble fiber from certain oat and barley food ingredients is mediated primarily by the effect of the beta-glucan soluble fiber on serum lipids. FDA's determination of significant scientific agreement that the totality of publicly available scientific evidence supports the relationship between beta-glucan soluble fiber from certain oat and barley foods and CHD risk is documented in rulemaking for § 101.81. When issuing the 1997 oat beta-glucan health claim final rule, the agency concluded that the beta-glucan soluble fiber component of oat products plays a significant role in the relationship between whole grain oats and the risk of CHD based, in part, on evidence that there is a dose response between the level of beta-glucan soluble fiber from whole oats and the level of reduction in serum LDL cholesterol, and evidence that intakes at or above 3 g per day were more effective in lowering serum lipids than lower intake levels (62 FR 3584 at 3585). In the 2002 and 2005 amendments to the health claim to add oatrim and whole grain and dry milled barley products, respectively, as eligible sources of beta-glucan soluble fiber, the agency considered evidence that beta-glucan soluble fiber from those sources had comparable cholesterol-lowering effects to that from the sources previously listed in § 101.81(c)(2)(ii)(A) as further support for FDA's previous determination that there is significant scientific agreement that a relationship exists between consumption of certain beta-glucan soluble fiber sources and reduced risk of CHD (67 FR 61773 at 61779 and 70 FR 76150 at 76155). Similarly, FDA considers that scientific evidence to establish that the cholesterol-lowering effects of beta-glucan soluble fiber from barley betafiber are comparable to the effects of beta-glucan soluble fiber from the oat/barley products in current § 101.81(c)(2)(ii)(A) builds on the substantial base of scientific evidence that already establishes significant scientific agreement for the association between consumption of the oat/barley products now listed and reduced risk of CHD. FDA's review of the evidence to support the petitioned amendment of the health claim regulation entitled “Soluble fiber from certain foods and risk of CHD” was conducted consistent with FDA published guidance on significant scientific agreement in the review of health claims (Ref. 9) and focused on evidence from intervention studies. B. Assessment of Intervention Studies This petition identified one relevant human randomized controlled trial of how consumption of beta-glucan soluble fiber from barley betafiber affects heart disease risk and serum lipid levels. A summary of this trial was included in the petition and subsequently published in a peer reviewed scientific journal (Ref. 4). FDA also evaluated reported results from randomized controlled trials of other types of beta-glucan concentrates, extracts, and gums (Refs. 10 through 19). The study reported in Keenan et al. 2007 (Ref. 4) investigated the effects of consuming concentrated barley beta-glucan soluble fiber-enriched foods (fruit drink and corn flakes) on blood lipids in hypercholesterolemic men and women. The study was conducted as a randomized, double-blind, placebo-controlled, parallel arm study of five groups with 30 to 32 subjects per group. The study included a total of 155 hypercholesterolemic adult subjects, between 25 and 73 years of age, with baseline serum LDL cholesterol levels between 140 and 190 milligrams per deciliter (mg/dL). The subjects were instructed to follow a diet low in saturated and *trans* fatty acids (less than 10 percent kilocalories (kcals) per day) and to consume three servings of the concentrated barley beta-glucan soluble fiber-enriched test foods per day, one serving with each of three major meals. The concentrated barley beta-glucan soluble fiber-enriched test foods were formulated to provide either 3 or 5 g of beta-glucan soluble fiber per day; a placebo version of the test foods without added barley beta-glucan extracts was also used. Two concentrated barley beta-glucan soluble fiber products were used; one is the barley betafiber produced from the manufacturing process described in section II.B of this preamble, and was described in the study report as a low molecular weight
(LMW)extract; the other concentrated barley beta-glucan soluble fiber product of the study was described as a high molecular weight
(HMW)beta-glucan extract. The HMW barley beta-glucan extract was processed in a fashion similar to that for barley betafiber but omitted the cellulase enzymatic hydrolysis step, thus producing a concentrated source of barley beta-glucan soluble fiber with a molecular weight similar to that of the endogenous beta-glucan soluble fiber in barley grain from which it was derived. Following a 4-week run-in period to adjust to the low saturated/ *trans* fat diet, the subjects were randomly assigned to one of five treatment groups: placebo control, 3 g per day barley betafiber, 5 g per day barley betafiber, 3 g per day HMW beta-glucan extract, and 5 g per day HMW beta-glucan extract. Subjects consumed the test foods daily for 6 weeks. Consumption of 3 or 5 g beta-glucan per day from barley betafiber significantly lowered serum total cholesterol levels (6.0 percent and 9.9 percent, respectively) relative to the placebo control group. Consumption of 3 or 5 g beta-glucan per day from the HMW barley beta-glucan extract also significantly lowered serum total cholesterol (7.0 percent and 11.2 percent, respectively) relative to the placebo control group. Serum LDL cholesterol levels were significantly decreased in all active treatment groups. At the end of the 5-week intervention period, the mean serum LDL cholesterol level of the 3 g per day beta-glucan from barley betafiber group was 10 mg/dL lower than the mean serum LDL cholesterol level of the placebo control group, representing a 7.5 percent reduction in LDL cholesterol relative to the placebo control group. The reduction in mean serum LDL cholesterol for the 5 g per day beta-glucan from barley betafiber group relative to the placebo control group was 16 mg/dL or 12 percent. The reduction in mean serum LDL cholesterol for the 3 g per day HMW beta-glucan group was 12 mg/dL or 8 percent relative to the placebo control group. For the 5 g per day HMW beta-glucan group, the reduction in mean LDL cholesterol was 19 mg/dL or 13 percent relative to the placebo control group. There were no statistically significant differences between barley betafiber and the HMW barley beta-glucan extract groups, or between 3 g per day or 5 g per day beta-glucan groups, in the magnitude of the cholesterol lowering effects. The magnitude of cholesterol-lowering reported by Keenan et al. (Ref. 4) for 3 and 5 g per day beta-glucan from barley betafiber is consistent with the magnitude of cholesterol-lowering observed with similar barley beta-glucan soluble fiber intake levels consumed as dry milled barley foods (70 FR 76150 at 76153). The randomized controlled trials with dry milled barley foods that FDA considered when previously amending the health claim to add dry milled barley had reported mean serum LDL cholesterol reductions of between 10 and 19 mg/dL from barley beta-glucan intake levels of 3 to 8 g per day. Based on evidence from the randomized controlled trials of dry milled barley ingredients which FDA relied upon when adding barley products to the health claim, the data for barley betafiber from Keenan et al. are consistent with the expected magnitude of cholesterol-lowering from consumption of the barley products listed in current § 101.81(c)(2)(ii)(A)( *5* ). Clinical trial evidence of oat/barley beta-glucan extracts other than barley betafiber indicate that not all oat/barley beta-glucan extracts affect serum total and LDL cholesterol levels as consistently as does consumption of the intact oat and barley grain from which they have been extracted (Refs. 10 through 19). This indicates that some extraction processes negatively affect whatever characteristics of beta-glucan soluble fiber in whole grain oats and barley that are responsible for the cholesterol-lowering effect. Accordingly, data from trials of beta-glucan extracts and concentrates other than barley betafiber support FDA's previous position (62 FR 3584 at 3587) that oat and barley products will be added to the health claim as eligible sources of beta-glucan soluble fiber only on a case-by-case basis when FDA is presented with adequate supporting evidence. Evidence from the randomized controlled trial reported by Keenan et al. (Ref. 4) indicates that beta-glucan soluble fiber from barley betafiber, prepared as described in section II of this preamble, is comparable to beta-glucan soluble fiber from the oat and barley sources now included in current § 101.81 in regard to cholesterol-lowering properties. Evidence from randomized controlled trials of other oat or barley beta-glucan extracts indicate that some forms of processing of oat and barley grain to extract or concentrate beta-glucan can negatively affect whatever properties of oat and barley beta-glucan are responsible for the cholesterol-lowering effect. Therefore, results from Keenan et al. can not be extrapolated to beta-glucan extracts other than the specific products tested in the trial. Results from the Keenan et al. trial also demonstrate that the serum cholesterol-lowering effects were comparable for beta-glucan soluble fiber from barley betafiber (i.e., the LMW product in the Keenan et al. trial) and for the barley beta-glucan extract that was not subjected to beta-glucan hydrolysis (the HMW product in the Keenan et al. trial) (Ref. 4). This evidence demonstrates that the cholesterol-lowering ability of beta-glucan soluble fiber in barley betafiber is not affected by the process used in the manufacture of barley betafiber to reduce the molecular weight of the barley betafiber product. IV. Decision to Amend the Health Claim Available evidence demonstrates that foods enriched with beta-glucan soluble fiber from barley betafiber at levels sufficient to provide at least 3 g beta-glucan soluble fiber per day are effective in lowering serum LDL-cholesterol levels, which may reduce the risk of CHD. As noted previously, when issuing the 1997 oat beta-glucan health claim final rule the agency concluded that the beta-glucan soluble fiber component of oat products plays a significant role in the relationship between whole grain oats and the risk of CHD based, in part, on evidence that there is a dose response between the level of beta-glucan soluble fiber from whole oats and the level of reduction in serum LDL cholesterol, and evidence that intakes at or above 3 g per day were more effective in lowering serum lipids than lower intake levels (62 FR 3584 at 3585). The clinical trial results reported by Keenan et al. (Ref. 4) demonstrating the cholesterol-lowering effect of consuming beta-glucan soluble fiber from barley betafiber are consistent in magnitude with what would be expected based on the oat beta-glucan soluble fiber/cholesterol-lowering dose-response evidence, which was cited in the 1997 oat beta-glucan health claim final rule, and cholesterol-lowering effect of consuming beta-glucan soluble fiber from dry milled barley grain ingredients (70 FR 76150 at 76155). Thus, FDA concludes that the cholesterol-lowering effect of beta-glucan soluble fiber from barley betafiber is comparable to that of beta-glucan soluble fiber from whole grain oat and dry milled barley sources currently listed in § 101.81(c)(2)(ii)(A). FDA also concludes that the scientific evidence supports a minimum daily effective intake of beta-glucan soluble fiber from barley betafiber the same as that which was previously found for whole oat and dry milled barley sources of beta-glucan soluble fiber, i.e., 3 g per day. Therefore, FDA is amending § 101.81, by adding § 101.81(c)(2)(ii)(A)( *6* ) to list barley betafiber as an eligible source of beta-glucan soluble fiber. Consistent with current § 101.81(c)(2)(i)(G)( *1* ), the source of the 3 g or more per day of beta-glucan soluble fiber may be from whole oats or barley, including the barley betafiber source, or a combination of oats and barley eligible sources. In addition, consistent with the description of other oat and barley products listed in current § 101.81, amended § 101.81 will specify barley betafiber by the method of production as described in section II.B of this preamble. The agency is satisfied that the description of the method for producing barley betafiber appropriately characterizes the barley product being added to the regulation. Further, barley beta-glucan can be measured by the same quantitative analytical method as is currently specified in § 101.81(c)(2)(ii)(A) for the determination of oat beta-glucan and barley beta-glucan from whole grain barley and dry milled barley products. Based on the totality of the publicly available scientific evidence, FDA concludes there is significant scientific agreement, among experts qualified by scientific training and experience, for a claim about the relationship between certain beta-glucan soluble fiber sources and reduced risk of CHD. Thus, FDA is amending § 101.81(c)(2)(ii)(A) to include barley betafiber derived from whole barley flour, prepared as described in section II.B of this document, as an additional source of beta-glucan soluble fiber. The requirement in § 101.81(c)(2)(iii)(A) states that a food bearing the claim on its label include one of the ingredients listed within § 101.81(c)(2)(ii)(A) and that the ingredient provide at least 0.75 gram of beta-glucan soluble fiber per reference amount customarily consumed
(RACC)of the food product. This level is based on the minimum daily effective intake of beta-glucan soluble fiber from barley betafiber and is the same as that which was previously found for whole oat and dry milled barley sources of beta-glucan soluble fiber, i.e., 3 g per day. FDA arrived at a value of 0.75 gram beta-glucan soluble fiber per RACC based on a standard assumption that the daily dietary intake is divided over four eating occasions per day (three meals and a snack) (62 FR 3584 at 3592). Thus, adding barley betafiber as an additional eligible source of beta-glucan soluble fiber will further increase the type and number of qualifying food products and make it easier for consumers to select barley and oat products at four eating occasions per day. Thus, FDA is retaining under the “Nature of the food eligible to bear the claim” section of the codified text of this interim final rule, the criterion that foods eligible to bear the claim contain at least 0.75 gram of soluble fiber (§ 101.81(c)(2)(iii)(A)( *2* )). There is strong consistent scientific evidence that diets high in saturated fat and cholesterol are associated with elevated serum total and LDL cholesterol, and that elevated serum cholesterol levels are a major modifiable risk factor for CHD. Expert groups recommend lowering dietary saturated fat and cholesterol as a primary lifestyle change for reducing heart disease risk (Ref. 8). Comments to the 1997 oat beta-glucan health claim final rule expressed concern that a CHD risk claim that does not include a reference to a low saturated fat, low cholesterol diet may mislead consumers into thinking that the single food, e.g., oat products, would appear to be a “magic bullet” (62 FR 3584 at 3594). Further, based on the scientific evidence, the role of soluble fiber from whole oats in the diet is generally recognized as being of smaller magnitude in reducing CHD risk compared to consumption of a low saturated fat, low cholesterol diet. When issuing the 1997 oat beta-glucan health claim final rule, FDA concluded that although selection of foods with soluble fiber from whole oats is a useful adjunct to selection of diets low in saturated fat and cholesterol, in reducing CHD risk, it would not be in the best interest of public health nor consistent with the scientific evidence to imply that selecting diets with soluble fiber from whole oats is a substitute for consuming diets low in saturated fat and cholesterol (id.). Therefore, FDA required in the 1997 oat beta-glucan health claim final rule that the health claim statement include the phrase “diets that are low in saturated fat and cholesterol and that include soluble fiber from * * *” (§ 101.81(c)(2)(i)(A)). FDA reiterated this position and extended it to soluble fiber from listed barley products when the agency amended § 101.81 to add whole grain barley and certain dry milled barley products as eligible sources of beta-glucan soluble fiber in 2005 (70 FR 76150 at 76156). Beta-glucan soluble fiber from barley betafiber functions comparably to beta-glucan soluble fiber from the listed oat and barley sources in current § 101.81(c)(2)(ii)(A) in its effect on reducing LDL and total cholesterol. Barley betafiber, as a source of beta-glucan soluble fiber, is a useful adjunct to selection of diets low in saturated fat and cholesterol to reduce CHD risk. Thus, the agency is requiring that the beta-glucan soluble fiber from barley betafiber health claim be subject to the requirements in § 101.81(c)(2)(i)(A). Including a reference to a low saturated fat, low cholesterol diet in the health claim will enable the public to understand the relative significance of the information in the context of a total daily diet (21 U.S.C. 343(r)(3)(A)(iii)). V. Description of Amendments to the Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease Health Claim Regulation A. Nature of the Substance; Eligible Sources of Soluble Fiber Section 101.81(c)(2)(ii) (nature of the substance) lists the types and sources of soluble fiber that have been demonstrated to FDA's satisfaction to have a relationship to a reduced risk of CHD. Section 101.81(c)(2)(ii)(A) lists beta-glucan soluble fiber from whole oat and barley sources, along with specifying an AOAC INTERNATIONAL method of analysis for beta-glucan soluble fibe, which will be used by FDA for verifying compliance. Section 101.81(c)(2)(ii)(A)( *1* ) through (c)(2)(ii)(A)( *5* ) identifies the whole oat and barley products that are eligible sources of beta-glucan, i.e., oat bran, rolled oats, whole oat flour, oatrim, whole grain barley, and dry milled barley. FDA is amending § 101.81(c)(2)(ii)(A) by adding § 101.81(c)(2)(ii)(A)( *6* ), which would specify barley betafiber as being the ethanol isolated, soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain barley flour, with a beta-glucan content of at least 70 percent on a dry weight basis (dwb). Thus, § 101.81(c)(2)(ii)(A)( *6* ) will read as follows “ *Barley betafiber* . Barley betafiber is the ethanol precipitated soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain barley. Barley betafiber is produced by hydrolysis of whole grain barley flour, as defined in paragraph (c)(2)(ii)(A)( *5* ) of this section, with a cellulase and alpha-amylase enzyme preparation, to produce a clear aqueous extract that contains mainly partially hydrolyzed beta-glucan and substantially hydrolyzed starch. The soluble, partially hydrolyzed beta-glucan is separated from the insoluble material by centrifugation, and after removal of the insoluble material, the partially hydrolyzed beta-glucan soluble fiber is separated from the other soluble compounds by precipitation with ethanol. The product is then dried, milled and sifted. Barley betafiber shall have a beta-glucan soluble fiber content of at least 70 percent on a dry weight basis.” B. Nature of the Food Eligible to Bear the Claim Section 101.81(c)(2)(iii)(A)( *2* ) (nature of the food) currently states “The food containing the oatrim from paragraph (c)(2)(ii)(A)( *4* ) of this section shall contain at least 0.75 g of beta-glucan soluble fiber per reference amount customarily consumed of the food product;” Because FDA is amending § 101.81 to add barley betafiber, FDA is amending § 101.81(c)(2)(iii)(A)( *2* ) as follows “The food containing the oatrim from paragraph (c)(2)(ii)(A)( *4* ) of this section or the barley betafiber from paragraph (c)(2)(ii)(A)( *6* ) of this section shall contain at least 0.75 g of beta-glucan soluble fiber per reference amount customarily consumed of the food product;” C. Other Requirements All other requirements in § 101.81(c)(1) through (c)(2)(i) and the optional information in § 101.81(d) will apply to the use of the health claim authorized in § 101.81 for barley betafiber-containing products. D. Model Health Claims This interim final rule to amend existing § 101.81(c)(2) does not affect the model health claims specified in paragraph
(e)of § 101.81. Thus, the model health claims in § 101.81(e) apply to a claim about beta-glucan soluble fiber from barley betafiber and a reduced risk of CHD. VI. Analysis of Impacts FDA has examined the impacts of this interim final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this interim final rule is not a significant regulatory action as defined by the Executive order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this interim final rule concerns voluntary claims, the agency certifies that the interim final rule will not have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $127 million, using the most current
(2006)Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this interim final rule to result in any 1-year expenditure that would meet or exceed this amount. FDA has identified the following three options regarding this petition:
(1)Deny the petition;
(2)authorize the petition (add only barley betafiber to the “Soluble fiber from certain foods and risk of coronary heart disease health claim“ in § 101.81 (the soluble fiber and CHD health claim)); or
(3)add barley betafiber to the soluble fiber-CHD health claim and also expand the scope of the claim to include all sources of soluble fiber. FDA concludes that authorizing the petition by adding barley betafiber to the soluble fiber and CHD health claim is the best option of those identified. *Option One: Deny the Petition* FDA can only define costs and benefits relative to a baseline. FDA usually selects the option of taking no action as the baseline because it helps readers identify the costs and benefits of actions that change the status quo. In this case, denying the petition would correspond to taking no action because it would imply no change in the soluble fiber and CHD health claim and thus the continuation of the status quo. By definition, the baseline itself has no costs or benefits. This does not mean that we ignore the costs and benefits of the baseline. Instead, it means that FDA expresses the costs and benefits of the baseline in how it calculates the costs and benefits of the other regulatory options. *Option Two: Authorize the Petition (Add Only Barley Betafiber to the Soluble Fiber and CHD Health Claim)* This option would allow producers who use barley betafiber to use the soluble fiber and CHD health claim on their product labels under certain conditions. Producers would only choose to change product labels or reformulate products if they believe that the benefits that they will derive from doing so are at least as great as the costs of making those changes. FDA has reviewed the data supplied in the petition and concludes that the claim is truthful and not misleading. If this interim final rule is finalized without change, FDA can be sure that to whatever extent producers use the claim, consumers will be in a better position, assuming that more information that is truthful and not misleading is always better for consumers. Based on this, FDA can conclude that adding barley betafiber to the soluble fiber and CHD health claim is better for social welfare than denying the petition. *Option Three: Add Barley Betafiber to the Soluble Fiber and CHD Health Claim and Also Expand the Scope of the Claim to Include All Sources of Soluble Fiber* This option would allow producers who use barley betafiber and all other sources of soluble fiber to use the soluble fiber and CHD health claim on their product labels under certain conditions rather than just listing specific sources of soluble fiber. Similar to option two, producers would only choose to change product labels or reformulate products if they believed that the benefits that they will derive from doing so are at least as great as the costs of making those changes. In addition, this option would reduce the future burden on manufacturers of petitioning FDA to use the soluble fiber and CHD health claim for additional sources of soluble fiber, and it would also reduce the agency's burden of evaluating each petition for each individual source of soluble fiber. However, by expanding the use of the claim to all sources of soluble fiber without reviewing the scientific data on each source, FDA would not be able to verify that the claim was being used under circumstances where it is truthful and not misleading to consumers. If the expanded claim was used on a product that did not reduce the risk of CHD, then the expanded claim could actually result in an increase in CHD. This would happen if consumers were misled into thinking that they were reducing their risk of CHD by consuming a product that actually did not reduce the risk of CHD. As a result, they might not take other beneficial steps that would decrease their risk of CHD. FDA cannot conclude that the cost savings of option three outweigh the increased risk of a false or misleading claim being made under the expanded claim. Therefore FDA cannot conclude that option three is better for social welfare than option two. Moreover, the agency believes that expanding the soluble fiber and CHD health claim to all sources of soluble fiber without reviewing the scientific data supporting such a claim of CHD risk reduction for each individual source of fiber would be a failure to carry out our statutory responsibility under section 403(r)(3)(B) of the act to issue health claim regulations only when the agency determines that there is significant scientific agreement that the claim is supported by the totality of publicly available scientific evidence. VII. Environmental Impact The agency has determined under 21 CFR 25.32(p) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. VIII. Paperwork Reduction Act of 1995 FDA concludes that the labeling provisions of this interim final rule are not subject to review by the Office of Management and Budget because they do not constitute a “collection of information” under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the food labeling health claim on the association between consumption of barley betafiber beta-glucan soluble fiber and CHD risk is a “public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public” (see 5 CFR 1320.3(c)(2)). IX. Federalism FDA has analyzed this interim final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule has a preemptive effect on State law. Section 4(a) of the Executive order requires agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Section 403A of the act (21 U.S.C. 343-1) is an express preemption provision. Section 403A(a)(5) of the act provides that “* * * no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce—* * * any requirement respecting any claim of the type described in section 403(r)(1) of the act made in the label or labeling of food that is not identical to the requirement of section 403(r). * * *” Currently, this provision operates to preempt States from imposing health claim labeling requirements concerning beta-glucan soluble fiber from barley betafiber and reduced risk of CHD because no such requirement had been imposed by FDA under section 403(r) of the act. This interim final rule, if finalized without change, would amend existing food labeling regulations to add barley betafiber as an eligible source of beta-glucan soluble fiber to the authorized health claim for soluble fiber from certain foods and risk of CHD. Although this rule would have a preemptive effect in that it would preclude States from issuing any health claim labeling requirements for beta-glucan soluble fiber from barley betafiber and a reduced risk of CHD that are not identical to those that would be required by this interim final rule, this preemptive effect is consistent with what Congress set forth in section 403A of the act. Section 403A(a)(5) of the act displaces both State legislative requirements and State common law duties. ( *Medtronic* v. *Lohr* , *518 U.S. 470, 503 (1996)* (Breyer, J., concurring in part and concurring in judgment); *id. at 510* (O'Connor, J., joined by Rehnquist, C.J., Scalia, J., and Thomas, J., concurring in part and dissenting in part); *Cipollone* v. *Liggett Group, Inc* ., 505 U.S. 504, 521
(1992)(plurality opinion); *id. at 548-49* (Scalia, J., joined by Thomas, J., concurring in judgment in part and dissenting in part). FDA believes that the preemptive effect of this interim final rule, if finalized without change, is consistent with Executive Order 13132. Section 4(e) of the Executive order provides that “when an agency proposes to act through adjudication or rulemaking to preempt State law, the agency shall provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings.” FDA provided the States with an opportunity for appropriate participation in this rulemaking on December 12, 2007, when FDA's Division of Federal and State Relations provided notice via fax and email transmission to State health commissioners, State agriculture commissioners, food program directors, and drug program directors as well as FDA field personnel of FDA's intent to amend the health claim regulation authorizing health claims for soluble fiber from certain foods and risk of CHD (§ 101.81). It advised the States of FDA's possible action and encouraged the States and local governments to review the petition and to provide any comments to the docket (Docket No. 2006P-0393), until January 12, 2008. FDA received no comments in response to the notice. FDA is also providing an opportunity for State and local officials to comment on this interim final rule. In conclusion, the agency has determined that the preemptive effects of this interim final rule are consistent with Executive Order 13132. X. Issuance of an Interim Final Rule and Immediate Effective Date FDA is issuing this rule as an interim final rule, effective immediately, with an opportunity for public comment. Section 403(r)(7) of the act authorizes us to make proposed regulations issued under section 403(r) of the act effective upon publication pending consideration of public comment and publication of a final regulation, if the agency determines that such action is necessary for public health reasons. This authority enables us to act promptly on petitions that provide for information that is necessary to:
(1)Enable consumers to develop and maintain healthy dietary practices,
(2)enable consumers to be informed promptly and effectively of important new knowledge regarding nutritional and health benefits of food, or
(3)ensure that scientifically sound nutritional and health information is provided to consumers as soon as possible. Proposed regulations made effective upon publication under this authority are deemed to be final agency action for purposes of judicial review. The legislative history indicates that such regulations should be issued as interim final rules (H. Conf. Rept. No. 105-399, at 98 (1997)). We are satisfied that all three of the criteria in section 403(r)(7)(A) of the act have been met for the amendment to the soluble fiber from certain foods and risk of CHD health claim to list barley betafiber as eligible source of beta-glucan soluble fiber. This health claim amendment will help enable consumers to develop and maintain healthy dietary practices. The health claim will also provide consumers with important knowledge regarding the effects of beta-glucan soluble fiber in reducing the risk of, and will provide consumers with scientifically sound information on the benefits of foods containing beta-glucan soluble fiber from barley betafiber. Therefore, we are using the authority given to us in section 403(r)(7)(A) of the act to issue an interim final rule authorizing a health claim for soluble fiber from barley betafiber and CHD, effective immediately. FDA invites public comment on this interim final rule. The agency will consider modifications to this interim final rule based on comments made during the comment period. Interested persons may submit to the Division of Dockets Management, in any of the ways noted in the ADDRESSES section at the beginning of this document, comments regarding this interim final rule by (see DATES ). Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. This regulation is effective upon publication in the **Federal Register** . The agency will address comments and confirm or amend the interim final rule in a final rule. XI. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only. XII. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the **Federal Register** .) 1. Cargill, Inc., “Petition for Health Claim—Barley Betafiber and Coronary Heart Disease,” (Docket 2006P-0393 CP1), June 20, 2006. 2. Cargill, Inc., ”Petition for Health Claim—Barley Betafiber and Coronary Heart Disease,” Appendix 4, (Docket 2006P-0393), June 20, 2006. 3. Cargill, Inc., “Petition for Health Claim—Barley Betafiber and Coronary Heart Disease,” Appendix 1, (Docket 2006P-0393), June 20, 2006. 4. Keenan, J.M., Goulson, M., Shamliyan, T., et al., ”The Effects of Concentrated Barley Beta-Glucan on Blood Lipids in a Population of Hypercholesterolaemic Men and Women,” *British Journal of Nutrition* , 97:1162-1168, 2007. 5. E-mail from Lore Kolberg, Cargill, Inc., to Jillonne Kevala, FDA, August 28, 2006. 6. Cooper, R., Cutler, J., Desvigne-Nickens, P., et al., “Trends and Disparities in Coronary Heart Disease, Stroke, and Other Cardiovascular Diseases in the United States: Findings of the National Conference on Cardiovascular Disease Prevention,” *Circulation* , 102:3137-3147, 2000. 7. Agency Response Letter to Generally Recognized as Safe Notice No. GRN 000207, FDA, Center for Food Safety and Applied Nutrition, Office of Food Additive Safety, December 19, 2006. 8. National Heart, Lung, and Blood Institute; National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Pressure in Adults (Adult Treatment Panel III), Third Report of the NCEP Adult Treatment Panel III, Executive Summary, Bethesda (MD): National Institutes of Health, National Heart, Lung and Blood Institute, ( *www.nhlbi.nih.gov/guidelines/cholesterol/atp_iii.htm* ), May 2001. 9. Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements, Rockville, MD: U.S. Food and Drug Administration; December 1999, Available from: *http://www.cfsan.fda.gov/~dms/ssaguide.html* . 10. Biörklund, M., vanRees, A., Mensink, R.P., et al., “Changes in Serum Lipids and Postprandial Glucose and Insulin Concentrations After Consumption of Beverages with β-Glucans from Oats or Barley: A Randomized Dose-Controlled Trial,” *European Journal of Clinical Nutrition* , 59:1272-1281, 2005. 11. Keogh, G.F., Cooper, G.J.S., Mulvey, T.B., et al., “Randomized Controlled Crossover Study of the Effect of a Highly β-Glucan-Enriched Barley on Cardiovascular Disease Risk Factors in Mildly Hypercholesterolemic Men,” *American Journal of Clinical Nutrition* , 78:711-718, 2003. 12. Kerckhoffs, D.A.J.M., Hornstra, G., and R.P. Mensink, “Cholesterol-Lowering Effect of β-Glucan from Oat Bran in Mildly Hypercholesterolemic Subjects May Decrease When β-Glucan is Incorporated Into Bread and Cookies,” *American Journal of Clinical Nutrition* , 78:221-227, 2003. 13. Lovegrove, J.A., Clohessy, A., Milon, H., et al, “Modest Doses of β-Glucan Do Not Reduce Concentrations of Potentially Atherogenic Lipoproteins,” *American Journal of Clinical Nutrition* , 72:49-55, 2000. 14. Naumann, E., vanRees, A.B., Önning, G., et al., “β-Glucan Incorporated Into a Fruit Drink Effectively Lowers Serum LDL-Cholesterol Concentrations,” *American Journal of Clinical Nutrition* , 83:601-605, 2006. 15. Pick, M.E., Hawrysh, Z.J., Gee, M.I., et al., “Oat Bran Concentrate Bread Products Improve Long-Term Control of Diabetes: A Pilot Study,” *Journal of the American Dietetic Association* , 96:1254-1261, 1996. 16. Beer, M.U., Arrigoni, E., and R. Amado, “Effects of Oat Gum on Blood Cholesterol Levels in Healthy Young Men,” *European Journal of Clinical Nutrition* , 49:517-522, 1995. 17. Braaten, J.T., Wood, P.J., Scott, F.W., et al., “Oat β-Glucan Reduces Blood Cholesterol Concentration in Hypercholesterolemic Subjects,” *European Journal of Clinical Nutrition* , 48:465-474, 1994. 18. Pomeroy, S., Tupper, R., Cehun-Anders, and P. Nestel, “Oat β-Glucan Lowers Total and LDL-Cholesterol,” *Australian Journal of Nutrition and Dietetics* , 58:51-55, 2001. 19. Törrönen, R., Kansanen, L., Uusitupa, M., et al., “Effects of an Oat Bran Concentrate on Serum Lipids in Free-Living Men with Mild to Moderate Hypercholesterolemia,” *European Journal of Clinical Nutrition* , 46:621-627, 1992. List of Subjects in 21 CFR Part 101 Food labeling, Nutrition, Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 101 is amended as follows: PART 101—FOOD LABELING 1. The authority citation for 21 CFR part 101 continues to read as follows: Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271. 2. Section 101.81 is amended by adding paragraph (c)(2)(ii)(A)( *6* ) and by revising paragraph (c)(2)(iii)(A)( *2* ) to read as follows: § 101.81 Health claims: Soluble fiber from certain foods and risk of coronary heart disease (CHD).
(c)* * *
(2)* * *
(ii)* * *
(A)* * * ( *6* ) *Barley betafiber* . Barley betafiber is the ethanol precipitated soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain barley. Barley betafiber is produced by hydrolysis of whole grain barley flour, as defined in paragraph (c)(2)(ii)(A)( *5* ) of this section, with a cellulase and alpha-amylase enzyme preparation, to produce a clear aqueous extract that contains mainly partially hydrolyzed beta-glucan and substantially hydrolyzed starch. The soluble, partially hydrolyzed beta-glucan is separated from the insoluble material by centrifugation, and after removal of the insoluble material, the partially hydrolyzed beta-glucan soluble fiber is separated from the other soluble compounds by precipitation with ethanol. The product is then dried, milled and sifted. Barley betafiber shall have a beta-glucan soluble fiber content of at least 70 percent on a dry weight basis.
(iii)* * *
(A)* * * ( *2* ) The food containing the oatrim from paragraph (c)(2)(ii)(A)( *4* ) of this section or the barley betafiber from paragraph (c)(2)(ii)(A)( *6* ) of this section shall contain at least 0.75 g of beta-glucan soluble fiber per reference amount customarily consumed of the food product; or Dated: February 15, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8-3418 Filed 2-22-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF JUSTICE 28 CFR Part 16 [CPCLO Order No.: 001-2008] Privacy Act of 1974; System of Records AGENCY: Federal Bureau of Investigation, Department of Justice. ACTION: Final rule. SUMMARY: The Federal Bureau of Investigation (FBI), a component agency of the Department of Justice (DOJ), is issuing a final rule exempting a new Privacy Act system of records, the Law Enforcement National Data Exchange. The FBI published a system of records notice for N-DEx and a proposed rule implementing these exemptions on October 4, 2007. The listed exemptions are necessary to avoid interference with the law enforcement functions and responsibilities of the FBI. This document addresses public comments on the proposed rule. DATES: This final rule is effective February 25, 2008. FOR FURTHER INFORMATION CONTACT: Kirsten J. Moncada, Director, Office of Privacy and Civil Liberties, 950 Pennsylvania Avenue, NW., Washington, DC 20530, or facsimile 202-616-9627. SUPPLEMENTARY INFORMATION: On October 4, 2007, the FBI issued a system of records notice at 72 FR 56793, for a new Privacy Act records system, JUSTICE/FBI-020, the Law Enforcement National Data Exchange (N-DEx), and a notice of proposed rulemaking, at 72 FR 56704, to exempt it from subsections (c)(3) and (4); (d)(1), (2), (3), and (4); (e)(1), (2), (3), (5), and (8); and
(g)of the Privacy Act. The FBI explained that the exemptions were necessary in order to avoid interference with the FBI's law enforcement functions and responsibilities. Two thoughtful comments from individuals were received on the proposed exemptions. One commenter supported the claimed exemptions, observing that they were “most assuredly necessary.” While noting that the exemptions were “an admirable attempt at balancing privacy and safety interests,” the other commenter expressed concern about the FBI's exemption of the system from the amendment/correction provisions of subsection
(d)of the Privacy Act. This commenter provided two suggestions for ways to permit amendment of N-DEx records. While the FBI appreciates the suggestions, the second one, amending the current law, would require legislation which is the purview of Congress and not the Executive Branch. The other suggestion, to apply the exemption for a temporal period only (such as the 30-day period envisioned in subsection (d)(3) for responding to Privacy Act requests or some longer period), would place the FBI in the administratively untenable position of having to verify with multiple law enforcement entities the status of any investigation, whether at the state, local or Federal level. The FBI notes that under the operating procedures of N-DEx, any entity that wishes to use information from the system for a law enforcement purpose is required to verify the accuracy of the data with the submitter, which provides a mechanism for ensuring that the information is accurate and timely. The FBI also notes that although it has proposed to exempt the system from the access and amendment provisions of the Privacy Act, FBI information in the system can be requested under the Freedom of Information Act. Consequently, individuals potentially have a means to obtain data from closed investigations and can still submit letters of disagreement if some information is determined to be incorrect. See 28 CFR 16.46. The FBI agrees with the commenter that having accurate law enforcement information is necessary, but believes that the system has built-in mechanisms to ensure that the information to be maintained—and more importantly used—is correct, and that the burdens from allowing access and amendment, coupled with the other reasons underlying the exemption, outweigh the benefit to be gained in this case. The FBI's claim of exemption from the access and amendment provisions of the Privacy Act is consistent with the principles of public policy reflected in the Privacy Act, which allows an agency to exempt itself from certain Privacy Act rules in order to avoid “undesirable and often unacceptable effects upon agencies in the conduct of necessary public business.” See Office of Management and Budget, Privacy Act Implementation Guidelines and Responsibilities, 40 FR 28948, 28971 (July 9, 1975). After careful consideration of the public comments, the FBI has determined that no substantive changes are warranted in the proposed rule and that it should be issued in final form. The FBI, however, is making two minor typographical changes in the final rule: the insertion of subparagraph letters for paragraph 7 and the renumbering of subparagraph
(10)to fix a numeration error. Regulatory Flexibility Act This rule relates to individuals, as opposed to small business entities. Nevertheless, pursuant to the requirements of the Regulatory Flexibility Act, the rule will not have a significant economic impact on a substantial number of small entities. Small Entity Inquiries The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 requires the FBI to comply with small entity requests for information and advice about compliance with statutes and regulations within FBI jurisdiction. Any small entity that has a question regarding this document may contact the person listed in FOR FURTHER INFORMATION CONTACT . Persons can obtain further information regarding SBREFA on the Small Business Administration's Web page at *http://www.sba.gov/advo/laws/law_lib.html.* Paperwork Reduction Act The Paperwork Reduction Act of 1995 requires that the FBI consider the impact of paperwork and other information collection burdens imposed on the public. There are no current or new information collection requirements associated with this rule. Analysis of Regulatory Impacts This rule is not a “significant regulatory action” within the meaning of Executive Order 12886. Because the economic impact should be minimal, further regulatory evaluation is not necessary. Moreover, the Attorney General certifies that this rule would not have a significant economic impact on a substantial number of small entities, because the reporting requirements themselves are not changed and because it applies only to information on individuals. Unfunded Mandates Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)requires Federal agencies to assess the effects of certain regulatory actions on State, local, and tribal governments, and the private sector. UMRA requires a written statement of economic and regulatory alternatives for proposed and final rules that contain Federal mandates. A “Federal mandate” is a new or additional enforceable duty, imposed on any State, local, or tribal government, or the private sector. If any Federal mandate causes those entities to spend, in aggregate, $100 million or more in any one year the UMRA analysis is required. This rule would not impose Federal mandates on any State, local, or tribal government or the private sector. Executive Order 13132, Federalism The FBI has analyzed this rule under the principles and criteria of Executive Order 13132, Federalism. This action will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government, and therefore, will not have federalism implications. Environmental Analysis The FBI has reviewed this action for purposes of the National Environmental Policy Act of 1969
(NEPA)and has determined that this action will not have a significant effect on the human environment. Energy Impact The energy impact of this action has been assessed in accordance with the Energy Policy and Conservation Act (EPCA), as amended (42 U.S.C. 6362). This rulemaking is not a major regulatory action under the provisions of the EPCA. List of Subjects in 28 CFR Part 16 Administrative Practices and Procedures, Courts, Freedom of Information Act, Government in the Sunshine Act, and the Privacy Act. Pursuant to the authority vested in the Attorney General by 5 U.S.C. 552a and delegated to me by Attorney General Order 793-78, 28 CFR part 16 is amended as follows: PART 16—[AMENDED] Subpart E—Exemption of Records Systems Under the Privacy Act 1. The authority citation for part 16 continues to read as follows: Authority: 5 U.S.C. 301, 552, 552a, 552b(g), 553; 18 U.S.C. 4203(a)(1); 28 U.S.C. 509, 510, 524; 31 U.S.C. 3717, 9701. 2. Section 16.96 is amended to add new paragraphs
(t)and
(u)as follows: § 16.96 Exemption of Federal Bureau of Investigation Systems—limited access.
(t)The following system of records is exempt from 5 U.S.C. 552a(c)(3) and (4); (d)(1), (2),
(3)and (4); (e)(1), (2), (3),
(5)and (8); and
(g)of the Privacy Act:
(1)Law Enforcement National Data Exchange (N-DEx), (JUSTICE/FBI-020).
(2)These exemptions apply only to the extent that information in this system is subject to exemption pursuant to 5 U.S.C. 552a(j)(2). Where compliance would not appear to interfere with or adversely affect the law enforcement purposes of this system, or the overall law enforcement process, the applicable exemption may be waived by the FBI in its sole discretion.
(u)Exemptions from the particular subsections are justified for the following reasons:
(1)From subsection (c)(3) because this system is exempt from the access provisions of subsection (d). Also, because making available to a record subject the accounting of disclosures from records concerning him/her would specifically reveal any investigative interest in the individual. Revealing this information may thus compromise ongoing law enforcement efforts. Revealing this information may also permit the record subject to take measures to impede the investigation, such as destroying evidence, intimidating potential witnesses or fleeing the area to avoid the investigation.
(2)From subsection (c)(4) because this system is exempt from the access and amendment provisions of subsection (d).
(3)From subsections (d)(1), (2), (3), and (4), because these provisions concern individual access to and amendment of investigatory records, compliance with which could alert the subject of an investigation of the fact and nature of the investigation, and/or the investigative interest of the FBI and other law enforcement agencies; interfere with the overall law enforcement process by leading to the destruction of evidence, improper influencing of witnesses, fabrication of testimony, and/or flight of the subject; possibly identify a confidential source or disclose information which would constitute an unwarranted invasion of another's personal privacy; reveal a sensitive investigative or intelligence technique; or constitute a potential danger to the health or safety of law enforcement personnel, confidential informants, and witnesses. Amendment of these records would interfere with ongoing investigations and other law enforcement activities and impose an impossible administrative burden by requiring investigations, analyses, and reports to be continuously reinvestigated and revised.
(4)From subsection (e)(1) because it is not always possible to know in advance what information is relevant and necessary for law enforcement purposes and, in fact, a major tenet of the N-DEx information sharing system is that the relevance of certain information may not always be evident in the absence of the ability to correlate that information with other existing law enforcement data.
(5)From subsection (e)(2) because application of this provision could present a serious impediment to efforts to solve crimes and improve homeland security in that it would put the subject of an investigation on notice of that fact, thereby permitting the subject to engage in conduct intended to frustrate or impede that activity.
(6)From subsection (e)(3) because disclosure would put the subject of an investigation on notice of that fact and would permit the subject to engage in conduct intended to thwart that activity. (7)(i) From subsection (e)(5) because many of the records in this system are records contributed by other agencies and the restrictions imposed by (e)(5) would limit the utility of the N-DEx system. All data contributors are expected to ensure that information they share is relevant, timely, complete and accurate. In fact, rules for use of the N-DEx system will require that information be updated periodically and not be used as a basis for action or disseminated beyond the recipient without the recipient first obtaining permission from the record owner/contributor. These rules will be enforced through robust audit procedures. The existence of these rules should ameliorate any perceived concerns about the integrity of the information in the N-DEx system. Nevertheless, exemption from this provision is warranted in order to reduce the administrative burden on the FBI to vouch for compliance with the provision by all N-DEx data contributors and to encourage those contributors to share information the significance of which may only become apparent when combined with other information in the N-DEx system.
(ii)The FBI is also exempting the N-DEx from subsection (e)(5) in order to block the use of a challenge under subsection (e)(5) as a collateral means to obtain access to records in the N-DEx. The FBI has exempted these records from the access and amendment requirements of subsection
(d)of the Privacy Act in order to protect the integrity of law enforcement investigations. Exempting the N-DEx system from subsection (e)(5) complements this exemption and will provide the FBI with the ability to prevent the assertion of challenges to a record's accuracy, timeliness, completeness and/or relevance under subsection (e)(5) to circumvent the exemption claimed from subsection (d).
(8)From subsection (e)(8), because to require individual notice of disclosure of information due to compulsory legal process would pose an impossible administrative burden on the FBI and may alert the subjects of law enforcement investigations to the fact of those investigations, when not previously known.
(9)From subsection
(g)to the extent that the system is exempt from other specific subsections of the Privacy Act. Dated: February 14, 2008. Kenneth P. Mortensen, Acting Chief Privacy and Civil Liberties Officer, Department of Justice. 8 [FR Doc. E8-3433 Filed 2-22-08; 8:45 am] BILLING CODE 4410-02-P DEPARTMENT OF DEFENSE Office of the Secretary [DoD-2006-OS-0023; RIN 0790-AH95] 32 CFR Part 240 Financial Assistance to Local Educational Agencies
(LEAs)AGENCY: Department of Defense. ACTION: Final rule. SUMMARY: The Department of Defense is removing 32 CFR Part 240, “Financial Assistance to Local Educational Agencies (LEAs).” The part has served the purpose for which it was intended and is no longer valid. DATES: *Effective Date:* February 25, 2008. FOR FURTHER INFORMATION CONTACT: L.M. Bynum, 703-696-4970. SUPPLEMENTARY INFORMATION: DoD Instruction 1342.18 was originally codified as 32 CFR part 240. This Instruction was reissued on February 6, 2006 and will no longer be codified in the Code of Federal Regulations. Copies of DoD Instruction 1342.18 may be obtained at *http://www.dtic.mil/whs/directives/.* List of Subject in 32 CFR Part 240 Elementary and secondary education; Federally affected areas; Grant programs-education. Accordingly, by the authority of 10 U.S.C., title 32 of the Code of Federal Regulations is amended by removing part 240: PART 240—[REMOVED] Dated: February 19, 2008. L.M. Bynum, Alternate OSD Federal Register Liaison Officer, DoD. [FR Doc. E8-3479 Filed 2-22-08; 8:45 am] BILLING CODE 5001-06-P DEPARTMENT OF TRANSPORTATION Saint Lawrence Seaway Development Corporation 33 CFR Part 401 [Docket No. SLSDC 2007-0005] RIN 2135-AA27 Seaway Regulations and Rules: Periodic Update, Various Categories AGENCY: Saint Lawrence Seaway Development Corporation, DOT. ACTION: Final rule. SUMMARY: The Saint Lawrence Seaway Development Corporation (SLSDC) and the St. Lawrence Seaway Management Corporation (SLSMC) of Canada, under international agreement, jointly publish and presently administer the St. Lawrence Seaway Regulations and Rules (Practices and Procedures in Canada) in their respective jurisdictions. Under agreement with the SLSMC, the SLSDC is amending the joint regulations by updating the Regulations and Rules in various categories. The changes will update the following sections of the Regulations and Rules: Condition of Vessels; Seaway Navigation; and, Information and Reports. The SLSDC is seeking to harmonize the ballast water requirements for vessels transiting the U.S. waters of the Seaway after having operated outside the exclusive economic zone
(EEZ)with those currently required by Canadian authorities for transit in waters under Canadian jurisdiction of the Seaway. These amendments are necessary to take account of updated procedures and will eliminate the confusion regarding the requirements for saltwater flushing in the binational waters of the Seaway System. DATES: The final rule will be effective March 26, 2008. FOR FURTHER INFORMATION CONTACT: Carrie Bedwell Mann, Chief Counsel, Saint Lawrence Seaway Development Corporation, 1200 New Jersey Avenue, SE., Washington, DC 20590,
(202)366-0091. SUPPLEMENTARY INFORMATION: The Saint Lawrence Seaway Development Corporation (SLSDC) and the St. Lawrence Seaway Management Corporation (SLSMC) of Canada, under international agreement, jointly publish and presently administer the St. Lawrence Seaway Regulations and Rules (Practices and Procedures in Canada) in their respective jurisdictions. Under agreement with the SLSMC, the SLSDC is amending the joint regulations by updating the Regulations and Rules in various categories. The changes will update the following sections of the Regulations and Rules: Condition of Vessels; Seaway Navigation; and, Information and Reports. The SLSDC is seeking to harmonize the ballast water requirements for vessels transiting the U.S. waters of the Seaway after having operated outside the exclusive economic zone
(EEZ)with those currently required by Canadian authorities for transit in waters under Canadian jurisdiction of the Seaway. These updates are necessary to take account of updated procedures which will enhance the safety of transits through the Seaway and eliminate the confusion regarding the requirements for saltwater flushing of ballast tanks containing only residual amounts of water and/or sediment in the binational waters of the Seaway. Several of the amendments are merely editorial or clarification of existing requirements. Where new requirements or regulations are being made, an explanation for such a change is provided below. *Regulatory Notices: Privacy Act:* Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the U.S. Department of Transportation's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (Volume 65, Number 70; Pages 19477-19478) or you may visit *http://www.Regulations.gov.* Discussion of Comments From the Notice of Proposed Rulemaking, 72 FR 74247, we received 15 letters or other forms of correspondence on the proposed regulation requiring saltwater flushing of ballast water tanks that contain residual amounts of water and/or sediment. Comments were received from: Congressman Vernon J. Ehlers, Minnesota Pollution Control Agency, Great Lakes Commission, Wisconsin Department of Natural Resources, Shipping Federation of Canada, McCabe Chapter of IWLA, National Oceanic and Atmospheric Administration, National Environmental Coalition on Invasive Species, Great Lakes United/Save The River/Alliance for the Great Lakes, Natural Resources Defense Council, the Polish Steamship Company, Ontario Ministry of Natural Resources, and 3 private citizens: Bruce Lindgren, Claire Duquette, and Dick Schwab. Most letters contained more than one comment on this issue. These included general comments as well as specific comments. We address the general comments first and then the specific comments. We did not receive any comments on the remaining proposed revisions to the joint Seaway regulations. General Comments All 15 comments supported the proposed regulations. Eleven
(11)of the commenters: Congressman Ehlers, McCabe Chapter of the IWLA, the Wisconsin Department of Natural Resources, Great Lakes Commission, National Oceanic and Atmospheric Administration, National Environmental Coalition on Invasive Species, Great Lakes United, National Wildlife Federation, National Resources Defense Council, Mr. Schwab and Mr. Lindgren, stated that while the regulation is an important step in the right direction, more needs to be done to reduce invasions of aquatic nuisance species (ANS). The SLSDC agrees with these comments and wants to emphasize that this regulation is intended to be an interim solution while the U.S. Coast Guard, the lead Federal agency charged with regulating ballast water discharges, completes its ballast water discharge standard rulemaking and the U.S. Congress continues work on National legislation to address this important issue. We will continue to work with the U.S. Coast Guard and our Canadian counterparts on efforts to combat the introduction of aquatic nuisance species. We will share the comments received in this docket with the U.S. Coast Guard to aid in their efforts to develop a discharge standard. Seven
(7)commenters: McCabe Chapter of the IWLA, Congressman Ehlers, Shipping Federation of Canada, Minnesota Pollution Control Agency, National Environmental Coalition on Invasive Species, Great Lakes United, National Wildlife Federation, acknowledge and support the need to harmonize the U.S. regulations with the Canadian regulations requiring saltwater flushing for vessels transiting the Seaway. The Polish Steamship Company acknowledged that this regulation will not result in any economic hardship to the company since its vessels are already required to conduct saltwater flushing 200 miles out at sea. We agree that harmonization of the saltwater flushing requirements for vessels transiting the binational waters of the Seaway system after having operated outside the EEZ will provide consistency between the U.S. and Canadian requirements for those vessels regardless of their port of destination. There has been a joint inspection program for both safety and environmental issues conducted in Montreal, Quebec for quite some time; however, this regulation will now provide inspectors with consistent requirements by both countries. Inspection personnel from all agencies will be inspecting vessels utilizing the same criteria. Specific Comments A majority of the commenters suggest making changes to the scope of the regulation. Six
(6)commenters: Great Lakes Commission, Minnesota Pollution Control Agency, National Environmental Coalition on Invasive Species, Great Lakes United, National Resources Defense Council, Ontario Ministry of Natural Resources, propose that the requirements should apply to Canadian and U.S. flagged vessels that operate outside the EEZ. One commenter, Great Lakes United, further proposed harmonizing the proposed rule with the Canadian rules that state the regulations apply to every ship in waters under Canadian jurisdiction. Great Lakes United would like the regulation clarified to state that if vessels are not covered by the U.S. Coast Guard regulations, the Seaway regulations would apply. They believe that this creates a loophole and not all oceangoing vessels will be required to conduct saltwater flushing. The intent of the U.S. regulation is to make consistent the requirements for vessels operating in the Seaway. The Canadian regulations require that Canadian vessels operating outside the EEZ conduct saltwater flushing. Additionally, the Canadian regulations apply to U.S. flagged vessels after operating outside the EEZ as well. We agree with the commenters and have modified the language of the rule to include U.S. and Canadian flagged vessels that have operated outside the EEZ in order to harmonize the rules with the Canadian requirements already in effect in the Canadian waters of the Seaway. Thus, all oceangoing vessels will be required to conduct saltwater flushing of ballast water tanks containing residual amounts of ballast water and/or sediment prior to entering the Seaway. The vessels are inspected at Montreal by the relevant agencies with jurisdiction over vessels en route to the Great Lakes, the two Seaway Corporations, U.S. Coast Guard, and Transport Canada, to ensure compliance with all ballast water requirements. One commenter, Minnesota Pollution Control Agency, recommends modifying 401.30(f)(1) to include vessels with no pumpable ballast on board. The commenter suggested that the proposed language was not clear whether the saltwater flushing requirement would apply to vessels declaring “No Ballast Onboard” (NOBOB). The joint regulation pertains to tanks containing residual amounts of water and/or sediment regardless of whether the vessel is a “Ballast on Board”
(BOB)or NOBOB vessel. Again, it is important to note that the U.S. Coast Guard is the lead agency for regulating ballast water discharges and is working on a ballast water discharge standard that would apply to all ballast water discharges regardless of whether the discharge is from a full tank or one containing only residual amounts of water and/ or sediment. Six commenters: Great Lakes Commission, Minnesota Pollution Control Agency, National Environmental Coalition on Invasive Species, Great Lakes United, National Wildlife Federation and the Ontario Ministry of Natural Resources, also suggested that the requirements should apply to all vessels including those operating exclusively within the U.S. and/or Canadian exclusive economic zone. The rule is intended to be consistent with the Canadian requirements already in force for the Canadian waters of the Seaway. The Canadian requirements for saltwater flushing do not apply to vessels operating exclusively inside the Canadian EEZ. We will share these comments with Transport Canada and the U.S. Coast Guard. Several commenters suggested strengthening the saltwater flushing requirements. One commenter, Great Lakes United, also proposes changing the word “should” in the definition of saltwater flushing to “shall” in two places. The commenter states that “given the limitation for safety, there is no reason not to require as much water as is safe rather than recommend it”. Additionally, they suggest that there is no reason not to require taking care to eliminate fresh or brackish water. The SLSDC agrees with this comment and has revised the proposed language in 401(f)(1) to reflect this suggestion. One commenter, National Wildlife Federation, suggested adding more detail to the requirements for saltwater flushing such as: • maximizing physical expulsion as well as salinity shock; • specifying how quickly salinity of at least 30 parts per thousand
(ppt)must be attained and how long residual organisms are exposed to salinity levels; • clarifying that the salinity requirement applies to residual water that is already highly saline; and • requiring saltwater flushing occur where the water depth is at least 2,000 meters. The SLSDC appreciates receiving these suggestions that would strengthen the requirements for saltwater flushing; however, these requirements are not consistent with harmonizing the U.S. regulations with the Canadian regulations for vessels operating in the Seaway. We agree that effective ballast water management practices are necessary and will share these comments with the U.S. Coast Guard and Transport Canada. One commenter, National Wildlife Federation, suggests that the salinity requirement should apply to sediment as well as resultant residual water. This is in the definition of saltwater flushing taken from the Canadian and U.S. Coast Guard Best Management Practices. Several comments centered on recordkeeping and compliance requirements. One commenter, Congressman Ehlers, urges vigorous enforcement of the new requirements through extensive monitoring and severe fines and penalties for violators. Three commenters: Minnesota Pollution Control Agency, Great Lakes United and the National Wildlife Federation, urge the SLSDC to strengthen the recordkeeping and reporting requirements related to achieving the required salinity in each tank to a minimum of 30 parts per thousand. The Minnesota Pollution Control Agency requests that the regulation be modified to explicitly require the measurements of salinity and records of the measurement time, date and geographic location of the vessel when the measurement was taken. One commenter, Great Lakes United, wants public access to information general from the reporting and enforcement. The agencies with jurisdiction over vessels en route to the Great Lakes basin: the two Seaway Corporations, the U.S. Coast Guard and Transport Canada will be inspecting the vessels entering the Seaway for compliance with ballast water management requirements. The inspectors will verify the accuracy of the information on the ballast water management report forms. The reporting form (and instructions) for ballast water management required to be completed prior to entering the Seaway will be available on the Seaway binational Web site at *http://www.greatlakes-seaway.com* prior to the opening of the 2008 navigation season. At the end of each navigation season, the agencies will publish a ballast water inspection report summary which will be made available to the public on the binational Web site. One commenter, Great Lakes United, proposes revising § 401.30(g) by changing “taken aboard” to “while” to ensure that noncompliant ballast water will not be released in the St. Lawrence River or Great Lakes even if no additional water is taken on. One
(1)commenter, Shipping Federation of Canada, proposed revising the language in 401.30(f) to make it clear that the ballast water should be retained only in a tank that is found to be noncompliant as opposed to requiring the entire ship to retain all ballast water in all tanks, even compliant tanks. The SLSDC agrees with this proposal and has modified the regulation to clarify that only a tank that is found noncompliant will be required to retain any ballast water while in the Seaway. In addition, the SLSDC revised the regulation based on the Great Lakes United suggestion to make clear that the water from the noncompliant tank is not to be discharged while the vessel is in the Seaway. Several commenters noted a typographical error in 401.30(f)(1) regarding the definition of saltwater flushing. The proposed rule refers to mixing “freshwater” with ballast water, when it should say either “saltwater” or flush water”. The final rule has been corrected to state flushwater in order to be consistent with the Canadian definition. Discussion of Final Rule In addition to the changes to the ballast water management requirements, the SLSDC is making changes to other sections of the joint regulations. The SLSDC is making one amendment to the Condition of Vessels section of the joint Seaway regulations. In § 401.12, “Minimum requirements—mooring lines and fairleads”, the language is modified to provide vessels the option of using mooring lines that are either wire or synthetic based upon the length of the vessel. Since mooring lines can be wire or synthetic some smaller vessels have presented themselves for transit with a mix of mooring wires/and or synthetic lines. Synthetic lines or hawsers are sufficient to moor the smaller vessels and mooring wire is more than capable of mooring the smaller vessels, therefore the use of either wire or synthetic lines will be acceptable. Several amendments to the joint regulations pertaining to Seaway Navigation are being made. In § 401.34, “Vessels in tow”, the SLSDC is adding a provision that would require every vessel in tow be inspected prior to every transit. The SLSDC is making this amendment to ensure navigation safety through inspection of all vessels even when a vessel is in tow. Currently such vessels are being inspected; however, this change will make it a mandatory requirement. As discussed above, the SLSDC is amending the joint regulations in § 401.30, “Ballast water and trim”. The amendment seeks to harmonize the requirements for saltwater flushing of ballast water tanks containing residual amounts of ballast water and/or sediment with the requirements already in place for vessels transiting Canadian waters of the Seaway System. Vessels transiting the Seaway traverse Canadian and U.S. waters multiple times en route to ports in the Great Lakes St. Lawrence Seaway System. The amendments would make the requirements for oceangoing vessels to conduct saltwater flushing of each ballast water tank that contains residual amounts of ballast water and/or sediment the same whether the vessel is transiting U.S. or Canadian waters of the Seaway after having operated outside the EEZ. The requirement for saltwater flushing of ballast tanks is intended to mirror the regulations already in effect in waters under Canadian jurisdiction for vessels transiting the Seaway. Specifically, the SLSDC, in agreement with the SLSMC, is amending the Seaway Regulations and Rules by adding new subsections
(f)and
(g)to § 401.30, “Ballast water and trim.” These new subsections will require that, as a condition of transiting the Seaway, every vessel must conduct a saltwater flushing of its ballast tanks that contain residual amounts of ballast water in an area 200 nautical miles from any shore before entering waters under Canadian jurisdiction. Saltwater flushing is defined as the addition of midocean water to ballast water tanks: the mixing of the flushwater with residual water and sediment through the motion of the vessel; and the discharge of the mixed water. The resultant residual water remaining in the tank must have a salinity level of at least 30 parts per thousand (ppt). Further, each vessel must maintain the ability to measure salinity levels in each tank onboard the vessel so that final salinities of at least 30 parts per thousand can be ensured. Any vessel that has tanks that fail to reach this salinity level will be required to retain any water in those tanks until it exits the Seaway. In addition, the SLSDC and SLSMC will continue to require that as a mandatory prerequisite for clearance of a vessel for transit of the Seaway System after operating beyond the EEZ, the vessel must agree to comply with the “Code of Best Practices for Ballast Water Management” of the Shipping Federation of Canada dated September 28, 2000. In light of the amount of interest and activity regarding control of aquatic nuisance species
(ANS)at all levels of government, especially in the U.S. Congress and the U.S. Coast Guard, the joint regulations will be reviewed and revised once either National legislation and/or regulations are issued that would pertain directly to this issue. In the meantime, this measure is intended to be an interim solution. In § 401.40, “Entering, exiting, or position in lock”, the SLSDC will prohibit a vessel, when it is being cast off in a lock, from departing in a manner that the stern passes the stop symbol on the local wall nearest the closed gates. Occasionally vessels drift backward in the lock while the mooring lines are being released; preventing the vessel's stern from passing the stop symbol will protect the vessel and the lock gates from possible damage. Other changes made to the joint regulations, including one to the regulations pertaining to Information and Reports, are merely editorial or for clarification purposes. Regulatory Evaluation This regulation is significant because of significant public interest in measures that address aquatic nuisance species and has been reviewed by the Office of Management and Budget. Regulatory Flexibility Act Determination I certify this regulation will not have a significant economic impact on a substantial number of small entities. The Saint Lawrence Seaway Regulations and Rules primarily relate to commercial users of the Seaway, the vast majority of whom are foreign vessel operators. Therefore, any resulting costs will be borne mostly by foreign vessels. Environmental Impact This regulation does not require an environmental impact statement under the National Environmental Policy Act (49 U.S.C. 4321, *et reg.* ) because it is not a major federal action significantly affecting the quality of the human environment. The environmental considerations applicable to the basic substance of this regulation are essentially discussed in the U.S. Coast Guard's Environmental Assessment for its May 17, 1999, “Implementation of the National Invasive Species Act of 1996” rulemaking (64 FR 26672) and the U.S. Coast Guard's Environmental Assessment for its August 31, 2005, “Ballast Water Management for Vessels Entering the Great Lakes That Declare No Ballast Onboard” (71 FR 4605). Federalism The Corporation has analyzed this rule under the principles and criteria in Executive Order 13132, dated August 4, 1999, and has determined that this proposal does not have sufficient federalism implications to warrant a Federalism Assessment. Unfunded Mandates The Corporation has analyzed this rule under Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 109 Stat. 48) and determined that it does not impose unfunded mandates on State, local, and tribal governments and the private sector requiring a written statement of economic and regulatory alternatives. Paperwork Reduction Act This regulation has been analyzed under the Paperwork Reduction Act of 1995 and does not contain new or modified information collection requirements subject to the Office of Management and Budget review. List of Subjects in 33 CFR Part 401 Hazardous materials transportation, Navigation (water), Penalties, Radio, Reporting and recordkeeping requirements, Vessels, Waterways. Accordingly, the Saint Lawrence Seaway Development Corporation is amending 33 CFR part 401, Regulations and Rules, as follows: PART 401—SEAWAY REGULATIONS AND RULES Subpart A—Regulations 1. The authority citation for subpart A of part 401 continues to read as follows: Authority: 33 U.S.C. 983(a) and 984(a) (4), as amended; 49 CFR 1.52, unless otherwise noted. 2. In § 401.12 paragraphs (a)(1) introductory text; (a)(1)(i), (a)(2) introductory text, (a)(3) introductory text, and (a)(4) introductory text are revised to read as follows: § 401.12 Minimum requirements—mooring lines and fairleads.
(a)* * * * *
(1)Vessels of 80 m or less in overall length shall have at least three mooring lines—wires or synthetic hawsers, two of which shall be independently power operated and one of which shall be hand held:
(i)One line shall lead forward from the break of the bow and one line shall lead astern from the quarter and be independently power operated by winches, capstans or windlasses and lead through closed chocks or fairleads acceptable to the Manager and the Corporation; and
(2)Vessels of more than 80 m but not more than 100 m in overall length shall have four mooring lines—wires or synthetic hawsers, of which three shall be independently power operated by winches, capstans or windlasses and one being hand held. All lines shall be led through closed chocks or fairleads acceptable to the Manager and the Corporation, of which three mooring lines:
(3)Vessels of more than 100 m but not more than 120 m in overall length shall have four mooring lines—wires or synthetic hawsers independently power operated by winches, capstan or windlasses as follows:
(4)Vessels of more than 120 m in overall length shall have four mooring lines—wires, two of which shall lead from the break of the bow and two of which shall lead from the quarter, and; 3. Section 401.27 is revised to read as follows: § 401.27 Compliance with instructions. Every vessel shall comply promptly with transit instructions given by the traffic controller or any other officer. 4. In § 401.29 paragraph
(a)is revised to read as follows: § 401.29 Maximum draft.
(a)The draft and speed of a vessel in transit shall be controlled by the master, who shall take into account the vessel's individual characteristics and its tendency to list or squat, so as to avoid striking bottom. 1 1 The main channels between the Port of Montreal and Lake Erie have a controlling depth of 8.23m. 5. Section 401.30 is amended by adding new paragraphs (f),
(g)and
(h)to read as follows: § 401.30 Ballast water and trim.
(f)As a condition of transit of the Seaway after having operated outside the exclusive economic zone
(EEZ)every vessel that carries only residual amounts of ballast water and/or sediment that were taken onboard the vessel outside the EEZ shall:
(1)Conduct a saltwater flushing of their ballast water tanks that contain the residual amounts of ballast water and/or sediment in an area 200 nautical miles from any shore before entering waters of the Seaway. Saltwater flushing is defined as the addition of mid-ocean water to ballast water tanks: The mixing of the flushwater with residual water and sediment through the motion of the vessel; and the discharge of the mixed water, such that the resultant residual water remaining in the tank has as high salinity as possible, and is at least 30 parts per thousand (ppt). The vessel shall take on as much mid-ocean water into each tank as is safe (for the vessel and crew) in order to conduct saltwater flushing. And adequate flushing may require more than one fill-mix-empty sequence, particularly if only small amounts of water can be safely taken onboard at one time. The master of the vessel is responsible for ensuring the safety of the vessel, crew, and passengers. Vessels reporting only residual ballast water onboard shall take particular care to conduct saltwater flushing on the transit to the Great Lakes so as to eliminate fresh and or brackish water residuals in ballast tanks; and
(2)Maintain the ability to measure salinity levels in each tank onboard the vessel so that final salinities of at least 30 ppt can be ensured.
(g)Every tank that is found not in compliance with 401.30(f) shall retain any ballast water until it exits the Seaway.
(h)These requirements do not apply to vessels of the armed forces, as defined in the Federal Water Pollution Control Act, or that are owned or operated by a state and used in government noncommercial service. 6. In § 401.31 paragraph
(c)introductory text is revised to read as follows: § 401.31 Meeting and passing.
(c)Except as instructed by the traffic controller, no vessel shall overtake and pass or attempt to overtake and pass another vessel— 7. Section 401. 34 is revised to read as follows: § 401.34 Vessels in tow. No vessel that is not self-propelled (including but not limited to tug/tows and/or deadship/tows) shall be underway in any Seaway waters unless it is securely tied to an adequate tug or tugs, in accordance with special instructions given by the Manager or the Corporation pursuant to § 401.33. Every vessel in tow has to be inspected prior to every transit unless it has a valid Seaway Inspection Certificate. The owner/master shall give a 24-hour notice of arrival when an inspection is requested. 8. Section 401.36 is revised to read as follows: § 401.36 Order of passing through. Vessels shall advance to a lock in the order instructed by the traffic controller. 9. In § 401.37, paragraph
(a)is revised to read as follows: § 401.37 Mooring at tie-up walls.
(a)Upon arrival at a lock, a vessel awaiting instructions to advance shall moor at the tie-up wall, close up to the designated limit or approach sign or to the ship preceding it, whichever is specified by the traffic controller or an officer. 10. In § 401.40, paragraph
(b)is revised to read as follows: § 401.40 Entering, exiting or position in lock.
(b)On being cast off in a lock, no vessel shall be allowed to fall back in such a manner that the stern passes the stop symbol on the lock wall nearest the closed gates. 11. In § 401.48, paragraph
(a)is revised to read as follows: § 401.48 Turning basins.
(a)With permission from the traffic controller; and 12. Section 401.49 is revised to read as follows: § 401.49 Dropping anchor or tying to canal bank. Except in an emergency, no vessel shall drop anchor in any canal or tie-up to any canal bank unless authorized to do so by the traffic controller. 13. In § 401.50, the introductory text is revised to read as follows: § 401.50 Anchorage areas. Except in an emergency, or unless authorized to do so by the traffic controller, no vessel shall drop anchor in any part of the Seaway except in the following designated anchorage areas: 14. In § 401.51, paragraph
(a)is revised to read as follows: § 401.51 Signaling approach to a bridge.
(a)Unless a vessel's approach has been recognized by a flashing signal, the master shall signal the vessel's presence to the bridge operator by VHF radio when it comes abreast of any of the bridge whistle signs. 15. In § 401.58, paragraph
(a)is revised to read as follows: § 401.58 Pleasure craft scheduling.
(a)The transit of pleasure craft shall be scheduled by the traffic controller or the officer in charge of a lock and may be delayed so as to avoid interference with other vessels; and 16. Section 401.83 is revised to read as follows: § 401.83 Reporting position at anchor, wharf, etc. A vessel anchoring in a designated anchorage area, or elsewhere, and a vessel mooring at a wharf or dock, tying-up to a canal bank or being held on a canal bank in any manner shall immediately report its position to the traffic controller and it shall not resume its voyage without the traffic controller's permission. Issued at Washington, DC on February 15, 2008. Saint Lawrence Seaway Development Corporation. Collister Johnson, Jr., Administrator. [FR Doc. E8-3323 Filed 2-22-08; 8:45 am] BILLING CODE 4910-61-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [MB Docket No. 99-25; FCC 07-204] Creation of a Low Power Radio Service AGENCY: Federal Communications Commission. ACTION: Final rule; correction. SUMMARY: The Federal Communications Commission
(FCC)is correcting a final rule that was published in the **Federal Register** on January 17, 2008 (73 FR 3202), and which becomes effective on March 17, 2008. DATES: Effective March 17, 2008. FOR FURTHER INFORMATION CONTACT: For additional information on this proceeding, contact Holly Saurer, *Holly.Saurer@fcc.gov* of the Media Bureau, Policy Division,
(202)418-2120. SUPPLEMENTARY INFORMATION: The Commission's *Third Report and Order,* FCC 07-204, adopted on November 27, 2007 and released on December 11, 2007, amends section 73.3598(a) of the Commission's rules. This rule change, listed as amendment 9 of the rule changes to part 73 on page 3218, omits the changes made to this rule by the Commission's *Report and Order,* FCC 07-228, in the Third Periodic Review of the Commission's Rules and Policies Affecting the Conversion To Digital Television, MB Docket No. 07-91, adopted on December 22, 2007 and released on December 31, 2007 ( *“Third DTV Periodic Report and Order”* ). The final rule in the *Third DTV Periodic Report and Order* that amended section 73.3598(a) was published in the **Federal Register** on January 30, 2008 (73 FR 5633) and also became effective on that date. Correction In rule FR Doc. E8-783 published on January 17, 2008 (73 FR 3218) make the following correction. On page 3218, the first column, paragraph no. 9 to the amendment of the rule to part 73 is corrected as follows: 9. Section 73.3598 is amended by revising paragraph
(a)to read as follows: § 73.3598 Period of construction.
(a)Each original construction permit for the construction of a new TV (including full-power DTV), AM, FM or International Broadcast; low power TV; TV translator; TV booster; FM translator; FM booster station; or to make changes in such existing stations, shall specify a period of three years from the date of issuance of the original construction permit within which construction shall be completed and application for license filed. Each original construction permit for the construction of a new LPFM station shall specify a period of eighteen months from the date of issuance of the construction permit within which construction shall be completed and application for license filed. A LPFM permittee unable to complete construction within the time frame specified in the original construction permit may apply for an eighteen month extension upon a showing of good cause. The LPFM permittee must file for an extension on or before the expiration of the construction deadline specified in the original construction permit. Federal Communications Commission. Marlene H. Dortch, Secretary. [FR Doc. E8-3533 Filed 2-22-08; 8:45 am] BILLING CODE 6712-01-P DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Part 578 [Docket No. NHTSA-2007-28445; Notice 2] RIN 2127-AK07 Civil Penalties AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT. ACTION: Final rule. SUMMARY: This document increases the maximum civil penalties for violations of the odometer tampering and disclosure requirements and certain administrative provisions of the Energy Policy and Conservation Act. This action is taken pursuant to the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996, which requires us to review and, as warranted, adjust penalties based on inflation at least every four years. DATES: This final rule is effective March 26, 2008. ADDRESSES: Petitions for reconsideration should refer to the docket number and be submitted to: Administrator, National Highway Traffic Safety Administration, 1200 New Jersey Avenue, SE., West Building, Fourth Floor, Washington, DC 20590, with a copy to the DOT docket. Copies to the docket may be submitted electronically through the Federal E-Rulemaking Portal at *http://www.regulations.gov.* Follow the online instructions for submitting comments. You may call Docket Management at 202-366-9324. The Docket room (Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.), hours are from 9 a.m. to 5 p.m., Monday through Friday, except Federal holidays. *Instructions:* For detailed instructions on submitting comments and additional information on the rulemaking process, see the Public Participation heading of the Supplementary Information section of this document. Note that all comments received will be posted without change to *http://www.regulations.gov,* including any personal information provided. Please see the Privacy Act heading below. *Privacy Act:* Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477-78). FOR FURTHER INFORMATION CONTACT: Michael Kido, Office of Chief Counsel, NHTSA, telephone
(202)366-5263, facsimile
(202)366-3820, 1200 New Jersey Avenue, SE., Washington, DC 20590. SUPPLEMENTARY INFORMATION: This rule adjusts for inflation certain maximum available penalty amounts and codifies the new amounts in 49 CFR part 578 *Civil and Criminal Penalties* . In order to preserve the remedial impact of civil penalties and to foster compliance with the law, the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990 (28 U.S.C. 2461 Notes, Pub. L. 101-410), as amended by the Debt Collection Improvement Act of 1996, (Pub. L. 104-134) (referred to collectively as the “Adjustment Act” or, in context, the “Act”), requires us and other Federal agencies to regularly adjust civil penalties for inflation. Under the Adjustment Act, following an initial adjustment that was capped by the Act, these agencies must make further adjustments, as warranted, to the amounts of penalties in statutes they administer at least once every four years. 1 1 As we indicated in our September 2007 notice of proposed rulemaking, since this rule will become effective in 2008, we used the 2007 consumer price index
(CPI)rather than the 2006 CPI in calculating the projected adjustment. Applying the 2007 CPI to our calculations did not alter the final increased amounts that we previously proposed. The changes to certain maximum penalties for violations of the odometer laws, regulations and orders and for violations of certain administrative procedures of the Energy Policy and Conservation Act of 1975 as amended and recodified
(EPCA)in today's rule were proposed and explained in our September 26, 2007 Notice of Proposed Rulemaking (NPRM). 72 FR 54635. The discussion in that notice is incorporated by reference. We received no comments to that notice. NHTSA is adjusting the maximum penalty for a single violation of the odometer tampering and disclosure requirements in 49 U.S.C. Chapter 327 or a regulation or order thereunder. The maximum penalty is codified at 49 CFR 578.6(f)(1). The agency last published a rule adjusting the maximum civil penalty for a single violation under 49 U.S.C. Chapter 327 in a rule published on February 4, 1997. 62 FR 5167. In today's rule, NHTSA is adjusting this amount from $2,200 to $3,200 based on the Adjustment Act, for the reasons set forth in the NPRM. Additionally, the agency is adjusting the maximum penalty amount for a single violation of certain administrative provisions of the EPCA found at 49 U.S.C. 32911(a). The maximum penalty is codified at 49 CFR 578.6(h)(1). This amount was last adjusted in a rule published on February 4, 1997. 62 FR 5167. After applying the statutory formulation described in the NPRM, the maximum civil penalty amount for a single violation is being adjusted from $11,000 to $16,000. The basis for this adjustment is set forth in the NPRM. Rulemaking Analyses and Notices Executive Order 12866 and DOT Regulatory Policies and Procedures We have considered the impact of this rulemaking action under Executive Order 12866 and the Department of Transportation's regulatory policies and procedures. This rulemaking document was not reviewed under Executive Order 12866, “Regulatory Planning and Review.” This action is limited to the adoption of adjustments of civil penalties under statutes that the agency enforces, and has been determined to be not “significant” under the Department of Transportation's regulatory policies and procedures. Regulatory Flexibility Act We have also considered the impacts of this notice under the Regulatory Flexibility Act. I certify that this final rule will not have a significant economic impact on a substantial number of small entities. The following provides the factual basis for this certification under 5 U.S.C. 605(b). The amendments potentially affect entities involved with odometers and manufacturers of motor vehicles. The Small Business Administration's regulations define a small business in part as a business entity “which operates primarily within the United States.” 13 CFR 121.105(a). SBA's size standards were previously organized according to Standard Industrial Classification
(SIC)Codes. SIC Code 336211 “Motor Vehicle Body Manufacturing” applied a small business size standard of 1,000 employees or fewer. SBA now uses size standards based on the North American Industry Classification System (NAICS), Subsector 336—Transportation Equipment Manufacturing, which provides a small business size standard of 1,000 employees or fewer for automobile manufacturing businesses. Other motor vehicle-related industries have lower size requirements that range between 500 and 750 employees. Many small businesses are subject to the penalty provisions of the odometer laws in 49 U.S.C. Chapter 327. Some small businesses are subject to the EPCA provisions in 49 U.S.C. 32911(a) and therefore may be affected by the adjustments that this final rule makes. As noted in this preamble, this rule increases only the maximum penalty amounts that the agency could obtain for a single violation of the odometer tampering and disclosure provisions and administrative provisions of EPCA. The rule does not set the amount of penalties for any particular violation or series of violations. Under the odometer laws, the applicable penalty provision requires the agency to take into account the ability to pay and any effect on the ability to continue doing business when determining the appropriate civil penalty in an individual case. *See* 49 U.S.C. 32709(a)(3)(B). Although EPCA does not provide for consideration of business size, it contains a provision for the compromise or remittitur of penalties for violations of 49 U.S.C. 32911(a). *See* 49 U.S.C. 32912(a) and 32913(a). The agency would also consider the size of a business under its civil penalty policy when determining the appropriate civil penalty amount for violations of 49 U.S.C. 32701 *et seq.* or 49 U.S.C. 32911(a). *See* 62 FR 37115 (July 10, 1997) (NHTSA's civil penalty policy under the Small Business Regulatory Enforcement Fairness Act (SBREFA)). The penalty adjustments that are promulgated by this rule do not affect our civil penalty policy under SBREFA. Since this regulation does not establish penalty amounts, this rule will not have a significant economic impact on small businesses. Small organizations and governmental jurisdictions are not significantly affected as the price of motor vehicles and equipment ought not to change as a result of this rule. As explained above, this action is limited to the adoption of a statutory directive, and has been determined to be not “significant” under the Department of Transportation's regulatory policies and procedures. Executive Order 13132 (Federalism) Executive Order 13132 requires NHTSA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, the agency may not issue a regulation with Federalism implications that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, the agency consults with State and local governments, or the agency consults with State and local officials early in the process of developing the regulation. This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. The reason is that this rule applies to motor vehicle manufacturers, and not to the States or local governments. Thus, the requirements of Section 6 of the Executive Order do not apply. Unfunded Mandates Reform Act of 1995 The Unfunded Mandates Reform Act of 1995, Public Law 104-4, requires agencies to prepare a written assessment of the cost, benefits and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually. Because this rule will not have a $100 million effect, no Unfunded Mandates assessment will be prepared. National Environmental Policy Act We have also analyzed this rulemaking action under the National Environmental Policy Act and determined that it will have no significant impact on the human environment. Executive Order 12778 (Civil Justice Reform) This rule does not have a retroactive or preemptive effect. Judicial review of this rule may be obtained pursuant to 5 U.S.C. 702. That section does not require that a petition for reconsideration be filed prior to seeking judicial review. Paperwork Reduction Act In accordance with the Paperwork Reduction Act of 1980, we state that there are no requirements for information collection associated with this rulemaking action. List of Subjects in 49 CFR Part 578 Motor vehicle safety, Penalties. In consideration of the foregoing, 49 CFR part 578 is amended as set forth below. PART 578—CIVIL AND CRIMINAL PENALTIES 1. The authority citation for part 578 continues to read as follows: Authority: Pub. L. 101-410, Pub. L. 104-134, Pub. L. 106-414, Pub. L. 109-59, 49 U.S.C. 30165, 30170, 30505, 32308, 32309, 32507, 32709, 32710, 32912, and 33115; delegation of authority at 49 CFR 1.50. 2. Section 578.6 of title 49, Code of Federal Regulations, is amended by revising paragraphs (f)(1) as (h)(1) to read as follows: § 578.6 Civil penalties for violations of specified provisions of Title 49 of the United States Code.
(f)*Odometer tampering and disclosure.*
(1)A person that violates 49 U.S.C. Chapter 327 or a regulation prescribed or order issued thereunder is liable to the United States Government for a civil penalty of not more than $3,200 for each violation. A separate violation occurs for each motor vehicle or device involved in the violation. The maximum civil penalty under this paragraph for a related series of violations is $130,000.
(h)*Automobile fuel economy.*
(1)A person that violates 49 U.S.C. 32911(a) is liable to the United States Government for a civil penalty of not more than $16,000 for each violation. A separate violation occurs for each day the violation continues. Issued on: February 7, 2008. Nicole R. Nason, Administrator. [FR Doc. E8-3518 Filed 2-22-08; 8:45 am] BILLING CODE 4910-59-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 071030625-8130-02] RIN 0648-XC84 Fisheries of the Northeastern United States; Summer Flounder, Scup, and Black Sea Bass Fisheries; 2008 Scup Specifications; Correction AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Final rule; correction. SUMMARY: On December 31, 2007, NMFS published in the **Federal Register** a final rule containing final specifications for the 2008 scup fishery. Inadvertently, table 3 of the final rule contained incorrect values for the 2008 Adjusted Quota Less Overages and Research Set-Aside
(RSA)for the scup quota periods. This document corrects those values. DATES: Effective February 25, 2008, through December 31, 2008. FOR FURTHER INFORMATION CONTACT: Emily Bryant, Fishery Management Specialist,
(978)281-9244. SUPPLEMENTARY INFORMATION: The final rule, including final quota specifications for the summer flounder, scup, and black sea bass fisheries, was published in the **Federal Register** on December 31, 2007 (72 FR 74197). Table 3 incorrectly lists the following Adjusted Quota Less Overages and RSA values for the scup quota periods: Winter I (2,367,373 lb, 1,074 mt), Summer (1,419,220 lb, 644 mt), Winter II (836,531 lb, 379 mt), and Total (4,623,124 lb, 2,097 mt). The correct amounts for the 2008 scup Adjusted Quota Less Overages and RSA are as follows: Winter I is 2,388,611 lb (1,083 mt); Summer is 1,437,558 lb (652 mt); Winter II is 844,036 lb (383 mt); and Total is 4,670,204 lb (2,118 mt). Classification Pursuant to 5 U.S.C. 553(b)(B), the Assistant Administrator finds good cause to waive prior notice and opportunity for additional public comment for this action because any delay of this action would be contrary to the public interest. As explained above, this rule corrects values for the 2008 Adjusted Quota Less Overages and RSA that had already been published in the **Federal Register** . To delay this correction notice will cause confusion over the available 2008 scup quota. The correct values for the adjusted quotas are greater than the values currently published in the **Federal Register** and a delay may negatively impact fishermen during the current Winter I quota period (January - April), who may not be able to harvest the full amount of quota allocated to the fishery. Moreover, pursuant to 5 U.S.C. 553(d), the Assistant Administrator finds good cause to waive the 30-day delay in effective date for the reasons given above. Delaying the rule for 30 days may negatively impact fishermen because the correct quota value for all quota periods, including the current Winter I period, are greater than the published values. This may lead to less quota being harvested for the Winter I period than is actually allocated to fishermen. Correction Accordingly, the final rule FR Doc. 07-6252, published on December 31, 2007 (72 FR 74197), is corrected as follows: 1. On page 74199, in Table 3, the Adjusted quota less overages and RSA found in columns 11 and 12 for the Winter I Quota period in row 1 are corrected to read “2,388,611” lb and “1,083” mt, respectively. 2. On page 74199, in Table 3, the Adjusted quota less overages and RSA found in columns 11 and 12 for the Summer Quota period in row 2 are corrected to read “1,437,558” lb and “652” mt, respectively. 3. On page 74200, in Table 3, the Adjusted quota less overages and RSA found in columns 11 and 12 for the Winter II Quota period in row 3 are corrected to read “844,036” lb and “383” mt, respectively. 4. On page 74200, in Table 3, the Adjusted quota less overages and RSA found in columns 11 and 12 for the Total Quota in row 4 are corrected to read “4,670,204” lb and “2,118” mt, respectively. Dated: February 19, 2008. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service. [FR Doc. E8-3522 Filed 2-22-08; 8:45 am] BILLING CODE 3510-22-S DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 071212833-8179-02] RIN 0648-XB94 Fisheries of the Northeastern United States; Atlantic Bluefish Fisheries; 2008 Atlantic Bluefish Specifications AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Final rule; final specifications for the 2008 Atlantic bluefish fishery. SUMMARY: NMFS issues final specifications for the 2008 Atlantic bluefish fishery, including state-by-state commercial quotas, a recreational harvest limit, and recreational possession limits for Atlantic bluefish off the east coast of the United States. The intent of these specifications is to establish the allowable 2008 harvest levels and possession limits to attain the target fishing mortality rate (F), consistent with the stock rebuilding program contained in Amendment 1 to the Atlantic Bluefish Fishery Management Plan (FMP), as well as ensuring compliance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). The final specifications are modified from those contained in the proposed rule as a result of more recent information on recreational harvests. DATES: This rule is effective March 26, 2008, through December 31, 2008. ADDRESSES: Copies of the specifications document, including the Environmental Assessment
(EA)and the Initial Regulatory Flexibility Analysis
(IRFA)are available from Daniel Furlong, Executive Director, Mid-Atlantic Fishery Management Council, Room 2115, Federal Building, 300 South Street, Dover, DE 19901 6790. The specifications document is also accessible via the Internet at *http://www.nero.noaa.gov* . NMFS prepared a Final Regulatory Flexibility Analysis (FRFA), which is contained in the classification section of this rule. The FRFA consists of the IRFA, public comments and responses contained in this final rule, and a summary of impacts and alternatives contained in this final rule. The small entity compliance guide is available from Patricia A. Kurkul, Regional Administrator, Northeast Regional Office, National Marine Fisheries Service, One Blackburn Drive, Gloucester, MA 01930 2298, and on the Northeast Regional Office's website at *http://www.nero.noaa.gov* . FOR FURTHER INFORMATION CONTACT: Tobey Curtis, Fishery Policy Analyst,
(978)281-9273. SUPPLEMENTARY INFORMATION: Background The Atlantic bluefish fishery is cooperatively managed by the Mid-Atlantic Fishery Management Council (Council) and the Atlantic States Marine Fisheries Commission (Commission). The regulations implementing the FMP appear at 50 CFR part 648, subparts A and J. Regulations requiring annual specifications are found at § 648.160. The management unit for Atlantic bluefish ( *Pomatomus saltatrix* ) is the U.S. waters of the western Atlantic Ocean. The FMP requires that the Council recommend, on an annual basis, total allowable landings
(TAL)for the fishery, consisting of a commercial quota and recreational harvest limit (RHL). A research set-aside
(RSA)quota is deducted from the bluefish TAL (after any applicable transfer) in an amount proportional to the percentage of the overall TAL as allocated to the commercial and recreational sectors. The annual review process for bluefish requires that the Council's Bluefish Monitoring Committee (Monitoring Committee) review and make recommendations based on the best available data, including, but not limited to, commercial and recreational catch/landing statistics, current estimates of fishing mortality, stock abundance, discards for the recreational fishery, and juvenile recruitment. Based on the recommendations of the Monitoring Committee, the Council makes a recommendation to the Northeast Regional Administrator (RA). Because the Bluefish FMP is a joint plan with the Commission, the Commission meets during the annual specification process to adopt complementary measures. In July 2007, the Monitoring Committee met to discuss the updated estimates of bluefish stock biomass and project fishery yields for 2008. In August 2007, the Council approved the Monitoring Committee's recommendations and the Commission's Bluefish Board (Board) adopted complementary management measures. Detailed background information regarding the status of the bluefish stock and the development of the 2008 specifications for this fishery was provided in the proposed specifications (72 FR 73304, December 27, 2007). That information is not repeated here. RSA Quota A request for proposals was published to solicit research proposals to utilize RSA in 2006 based on research priorities identified by the Council (December 27, 2006; 71 FR 77726). One research project that would utilize bluefish RSA has been preliminarily approved by the RA and forwarded to the NOAA Grants Office. Therefore, this final rule implements a 50,000-lb (22,680-kg) RSA quota for the 2008 bluefish fishery. If this project is not approved by the NOAA Grants Office, the research quota associated with the disapproved proposal will be restored to the bluefish TAL through publication in the **Federal Register** . Final Specifications The FMP specifies that the bluefish stock is to be rebuilt to B MSY over a 9-year period (i.e., by the year 2010). The FMP requires the Council to recommend, on an annual basis, a level of total allowable catch
(TAC)consistent with the rebuilding program in the FMP. An estimate of annual discards is deducted from the TAC to calculate the TAL that can be made during the year by the commercial and recreational fishing sectors combined. The TAL is composed of a commercial quota and a RHL. The FMP rebuilding program requires the TAC for any given year to be set based either on the target F resulting from the stock rebuilding schedule specified in the FMP (0.31 for 2008), or the F estimated in the most recent fishing year (F 2006 = 0.15), whichever is lower. Therefore, the 2008 recommendation is based on an estimated F of 0.15. An overall TAC of 31.887 million lb (14,464 mt) was recommended as the coast-wide TAC by the Council at its August 2007 meeting to achieve the target fishing mortality rate (F = 0.15) in 2008, and to ensure that the bluefish stock continues toward the long-term biomass target, B MSY = 324 million lb (147,052 mt), consistent with the rebuilding schedule specified in Amendment 1. Based on the 2006 biomass estimate (307.5 million lb (139,496 mt)), the bluefish stock is well above the minimum biomass threshold (1/2 B MSY = 162 million lb (73,526 mt)), but is still slightly below the long-term biomass target (B MSY = 324 million lb (147,052 mt)). The TAL for 2008 is derived by subtracting an estimate of discards of 3.734 million lb (1,694 mt), the average discard level from 2000-2006, from the TAC. After subtracting estimated discards, the 2008 TAL will be 28.156 million lb (12,771 mt), approximately 1.4 percent greater than the 2007 TAL. Based strictly on the percentages specified in the FMP (17 percent commercial, 83 percent recreational), the commercial quota for 2008 would be 4.787 million lb (2,171 mt), and the RHL would be 23.370 million lb (10,600 mt) in 2008. In addition, up to 3 percent of the TAL may be allocated as RSA quota. The discussion below describes the recommended allocation of TAL between the commercial and recreational sectors, and its proportional adjustment downward to account for the recommended bluefish RSA quota. Council Recommendation: Commercial Quota and Recreational Harvest Limit As described in the proposed rule, based on the best information available at the time, the Council recommended that 4.088 million lb (1,854 mt) be transferred from the initial recreational allocation of 23.370 million lb (10,600 mt), resulting in a 2008 commercial quota of 8.875 million lb (4,026 mt) and a RHL of 19.281 million lb (8,746 mt). These allocations were also recommended by the Commission to be implemented by the states for fisheries within state waters. Final 2008 Commercial Quota and Recreational Harvest Limit Although the Council recommendation was based on the best information available at the time, more recent information, which was not available at the time of the Council's recommendation or at the time of publication of the proposed rule, was used to develop a new recreational landings projection for the 2008 fishing year. This new recreational landings projection, when added to the commercial quota, as adjusted by the proposed transfer of bluefish from the allowable RHL, may cause the TAL to be exceeded. Such a result is inconsistent with § 648.160(c), which requires that the level of transfer be constrained to a level that does not cause the TAL to be exceeded. Based on data provided by the Marine Recreational Fisheries Statistic Survey (MRFSS) program, projected recreational landings in 2007 were approximately 20,414,621 lb (9,260 mt). Using this amount as the most reasonable proxy for expected landings in 2008, this final rule reduces the amount of the transfer from the recreational to the commercial sector by 1,169,756 lb (531 mt), from 4,088,449 lb (1,854 mt) to 2,918,693 lb (1,324 mt), commensurate with the increase in projected recreational landings. This results in a post-transfer commercial quota of 7,705,244 lb (3,495 mt) and a recreational harvest limit of 20,450,938 lb (9,276 mt). After adjusting for the RSA quota, the resulting 2008 specifications include a commercial quota of 7,691,561 lb (3,489 mt) and a recreational harvest limit of 20,414,621 lb (9,260 mt). The RSA quota remains unchanged at 50,000 lb (22,680 kg). Additional Adjustment for 2007 New York Overage In accordance with the regulations at § 648.160(e)(2), NMFS may deduct any overages of the commercial quota landed in any state from that state's annual quota for the following year. Updated landings information for FY 2007 indicate a bluefish quota overage for New York in the amount of 51,719 lb (23,459 kg). This final rule adjusts New York's 2008 bluefish quota downward by this amount to 747,057 lb (338,859 kg), to account for this overage. Final State Commercial Allocations The 2008 commercial quota is allocated by state as shown in Table 1, according to the percentages specified in the FMP. The table accounts for New York's 2007 quota overage. Table 1. Final Bluefish Commercial State-by-State Allocations for 2008 1 State Percent Share 2008 Commercial Quota
(lb)RSA Deducted 2008 Commercial Quota
(kg)RSA Deducted ME 0.6685 51,418 23,323 NH 0.4145 31,882 14,461 MA 6.7167 516,619 234,338 RI 6.8081 523,649 237,527 CT 1.2663 97,398 44,180 NY 10.3851 747,057 338.865 NJ 14.8162 1,139,595 516,920 DE 1.8782 144,463 65,528 MD 3.0018 230,885 104,730 VA 11.8795 913,716 414,462 NC 32.0608 2,465,973 1,118,565 SC 0.0352 2,707 1,228 GA 0.0095 731 331 FL 10.0597 773,748 350,972 Total 100.0001 7,639,842 3,465,432 1 The sum of the individual states does not add up to the final commercial quota of 7,639,841 lb due to rounding. Recreational Possession Limit NMFS has approved the Council's recommendation to maintain the current recreational possession limit of 15 fish per person to achieve the RHL. Comments and Responses The public comment period on the proposed rule ended on January 28, 2008, with only one comment received. *Comment 1:* The commenter suggested that the TAC be reduced by 50 percent initially, and by 10 percent in each subsequent year. The commenter also suggested that a December 2007, hypothermal fish kill in New Jersey had a detrimental impact on the overall bluefish population, and that the scientific methods used to estimate bluefish biomass were inaccurate. *Response:* The commenter gave no specific rationale for why the quotas should be reduced in the manner suggested, and there is no known scientific basis for the commenter's suggestions. According to the New Jersey Department of Environmental Protection, the December 2007 fish kill near the Oyster Creek Nuclear Power Generating Station in Ocean County, NJ, killed approximately 5,300 bluefish. Based upon estimates of total bluefish abundance in the June 2007 Bluefish Assessment Summary prepared by the Commission's Bluefish Stock Assessment Sub-Committee, this kill represented less than 0.01 percent of the total bluefish population in 2007 (89.2 million fish). The impact of the fish kill is therefore negligible relative to the total bluefish stock. The reasons presented by the Council and NMFS for recommending the final 2008 bluefish specifications are based on the best available science, and are discussed in the preambles to both the proposed and final rules. Sufficient analysis and scientific justification for NMFS's action in this final rule are contained within the supporting documents. Classification Pursuant to section 304 (b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this rule is consistent with the Atlantic Bluefish FMP, other provisions of the Magnuson-Stevens Act, and other applicable law. This final rule is exempt from review under Executive Order 12866. Included in this final rule is the FRFA prepared pursuant to 5 U.S.C. 604(a). The FRFA incorporates the IRFA, a summary of the significant issues raised by the public comments in response to the IRFA, and NMFS's responses to those comments, and a summary of the analyses completed to support the action. A copy of the EA/RIR/IRFA is available from the Council (see ADDRESSES ). The preamble to the proposed rule included a detailed summary of the analyses contained in the IRFA, and that discussion is not repeated here. Final Regulatory Flexibility Analysis Statement of Objective and Need A description of the reasons why this action is being taken, and the objectives of and legal basis for these specifications are explained in the preambles to the proposed rule and this final rule and are not repeated here. Summary of Significant Issues Raised in Public Comments One comment was submitted on the proposed rule, but it was not specific to the IRFA or the economic effects of the rule. NMFS has responded to the comment in the Comments and Responses section of the preamble to this final rule. No changes were made to the final rule as a result of the comment received. Description and Estimate of Number of Small Entities to Which the Rule will Apply The Small Business Administration
(SBA)defines small businesses in the commercial fishing and recreational fishing sectors as firms with receipts (gross revenues) of up to $4.0 million and $6.5 million, respectively. No large entities participate in this fishery, as defined in section 601 of the RFA. This rule could affect any vessels that fish for bluefish in Federal or state waters. The final measures regarding the 2008 quotas could affect any vessels holding an active Federal permit for bluefish, as well as vessels that fish for this species in state waters. The participants in the commercial sector were defined using two sets of data. First, the Northeast dealer reports were used to identify any vessel that reported having landed 1 lb (0.45 kg) or more of bluefish during calendar year 2006 (the last year for which there is complete data). These dealer reports identified 725 vessels that landed bluefish in states from Maine to North Carolina. However, this database does not provide information about fishery participation in South Carolina, Georgia, or Florida. South Atlantic Trip Ticket reports were used to identify 820 vessels 1 that landed bluefish in North Carolina and 567 vessels that landed bluefish on Florida's east coast. There were no reported landings of bluefish in South Carolina in 2006, and bluefish landings in Georgia were near zero, representing a negligible proportion of the total bluefish landings along the Atlantic Coast in 2006. 1 Some of these vessels were identified in the Northeast dealer data; therefore, double counting is possible. In addition, it was estimated that, in recent years, approximately 2,063 party/charter vessels may have been active and/or caught bluefish. All of these vessels are considered small entities under the RFA, having gross receipts of less than $5 million annually. Since the recreational possession limit will remain at 15 fish per person, there should be no impact on demand for party/charter vessel fishing, and, therefore, no impact on revenues earned by party/charter vessels. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements No additional reporting, recordkeeping, or other compliance requirements are included in this final rule. Description of the Steps Taken to Minimize Economic Impact on Small Entities Specification of commercial quota, recreational harvest levels, and possession limits is constrained by the conservation objectives of the FMP, under the authority of the Magnuson-Stevens Act. The commercial quota and RHL contained in this final rule are 13.2 percent lower and 6.1 percent higher, respectively, than the Council's preferred alternative contained in the proposed rule. Although the commercial quota under this new alternative is lower than the commercial quota recommended by the Council, and lower than the FY 2007 commercial quota of 8,574,939 lb (3,890 mt), it remains approximately 24 percent greater than FY 2007 commercial landings (6,209,915 lb; 2,817 mt). All affected states will receive reductions in their individual commercial quota allocation in comparison to their respective 2007 individual state allocations. However, the magnitude of the reduction varies depending on the state's respective percent share in the total commercial quota, as specified in the FMP, and depending on whether the state had any overages from FY 2007 that needed to be accounted for in this final rule (e.g., New York). NMFS considered a TAL that would have allowed a higher allocation of quota to the commercial sector, but this alternative, proposed by the Council, would have been inconsistent with the goals and objectives of the FMP and the Magnuson-Stevens Act. The new alternative, which will transfer less quota from the recreational sector to the commercial sector than the alternative contained in the proposed rule, is being implemented consistent with recent recreational landings trends and should ensure that the 2008 RHL is not exceeded. Furthermore, the RHL being implemented in this final rule is 8.5 percent higher than the RHL specified in FY 2007. In conclusion, because the 2008 commercial quota being implemented in this final rule is significantly greater than FY 2007 commercial landings, and the 2008 RHL represents an increase over the 2007 RHL, and because the revised 2008 RHL is consistent with recent trends in recreational landings, no negative economic impacts are expected relative to the status quo and the Council's preferred alternative. The impacts on revenues of the proposed RSA were analyzed; the social and economic impacts are minimal. Assuming that the full RSA of 50,000 lb (22,680 kg) is landed and sold to support the proposed research project (a supplemental finfish survey in the Mid-Atlantic), then all of the participants in the fishery would benefit from the anticipated improvements in the data underlying the stock assessments. Small Entity Compliance Guide Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, a small entity compliance guide will be sent to all holders of Federal permits issued for the Atlantic bluefish fishery. In addition, copies of this final rule and guide (i.e., permit holder letter) are available from NMFS (see ADDRESSES ) and at the following website: *http://www.nero.noaa.gov* . Dated: February 19, 2008. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service. [FR Doc. E8-3514 Filed 2-22-08; 8:45 am] BILLING CODE 3510-22-S DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 660 [Docket No.061219338-7494-03] RIN 0648-AU69 Fisheries off West Coast States and in the Western Pacific; Amendment 15 to the Pacific Coast Salmon Fishery Management Plan AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Final rule. SUMMARY: This final rule implements Amendment 15 to the Pacific Coast Salmon Fisheries Management Plan
(Plan)in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). This action is intended to provide management flexibility in times of low Klamath River fall-run Chinook
(KRFC)abundance, while preserving the long-term productive capacity of the stock and thereby ensuring it continues to contribute meaningfully to ocean and river fisheries in the future. DATES: This rule will be effective on March 26, 2008. ADDRESSES: Amendment 15 is available on the Pacific Fishery Management Council's (Council's) website at *http://www.pcouncil.org/salmon/salfmp.html* . FOR FURTHER INFORMATION CONTACT: Sarah McAvinchey by phone at 206- 526-6140, fax 206-526-6736 and email at *sarah.mcavinchey@noaa.gov* , or Eric Chavez by phone at 508-980-4064, email at *eric.chavez@noaa.gov* , fax 508-908-4047 or contact Pacific Fishery Management Council by phone at 503-820-2290 or by fax at 503-820-2299. SUPPLEMENTARY INFORMATION: The Council prepared Amendment 15 to the FMP under the provisions of the Magnuson-Stevens Act and submitted it for review by the Secretary of Commerce (Secretary). A notice of availability was published on December 20, 2006 (71 FR 76270). The decision to approve the Amendment was made on March 22, 2007, consistent with the Magnuson-Stevens Act. Details of Amendment 15 were given in the proposed rule and are not repeated here. A proposed rule for Amendment 15 was published in the **Federal Register** on May 15, 2007 (72 FR 27276). The comment period on the proposed rule closed on June 28, 2007. Comments and Responses During the comment period for proposed rule on Amendment 15 NMFS received 2 comments. One letter was sent by a member of the public, the other was sent by the Yurok Tribe. Comments received on the proposed rule are addressed here: *Comment 1:* The private citizen's letter stated that in order to save salmon runs the Snake River Dams need to be breached. *Response:* This is outside the scope of this action. *Comment 2:* The Yurok Tribe letter stated their concern regarding the lack of a set reduction schedule of acceptable age-four ocean impact rates on KRFC under the *de minimis* provisions of the Amendment. They encouraged the Secretary not to approve the rule. They stated that their concern was for the long term productivity and health of the KRFC stock and believe that this amendment does not fulfill the Federal Government's tribal trust obligations. They go on to state that this rule will not aid in dealing with the overfished status of the stock. They also referred NMFS to their previously submitted comments on the Amendment during that comment period. *Response:* NMFS shares the Yurok Tribe's concerns regarding the long term health of the KRFC stock and understands and takes seriously the trust responsibilities. NMFS believes the Amendment and this final rule are consistent with those responsibilities. NMFS does not interpret Amendment 15 to set a fixed schedule of allowable salmon harvest whenever the forecasted abundance of natural spawners falls within the range of 35,000 to 12,000. Rather, Amendment 15 allows the Council to recommend, without emergency rulemaking, the possibility of some de minimis harvest of KRFC in order to allow mixed stock ocean fisheries to occur when the preseason forecast of naturally-spawning KRFC falls below 35,000. In recognition of the concerns presented by the Yurok Tribe, NMFS has added more specific language to the regulatory text, to include the specifics of Amendment 15 and the list of considerations that the Council is required to evaluate in setting the age-four ocean impact rate. NMFS has also added a footnote to describe how NMFS interprets implementation of the *de minimis* fishing provisions, and to state that nothing in the Amendment or this final rule automatically predetermines that a particular level of harvest of KRFC will be acceptable or allowed. As noted in the proposed rule the extent of the harvest actually allowed in a particular year will be limited by the general requirements of the Magnuson-Stevens Act to maintain the capacity to produce maximum sustainable yield on a continuing basis, by the specific factors listed in Amendment 15, and by the requirement to meet trust responsibilities to affected Indian tribes. Changes from the Proposed Rule In the proposed rule NMFS added paragraph
(d)to § 660.410, which lists considerations the Council must make when setting the *de minimis* fishing provisions. This paragraph also includes a footnote stating how NMFS interprets the implementation of the *de minimis* fishing provisions of the Amendment. This final rule revised paragraph
(d)to state the required considerations from Amendment 15 and the requirements that NMFS must ensure that age-4 ocean impact rate will not jeopardize the long term capacity of the stock to produce maximum sustainable yield on a continuing basis. Classification The Administrator, Northwest Region, NMFS, determined that this final rule is necessary for the conservation and management of the Klamath River Fall-run Chinook fishery and that it is consistent with the Magnuson-Stevens Act and other applicable laws. The Council prepared an environmental assessment for this FMP amendment that discusses the impact on the environment as a result of this rule. A copy of the environmental assessment is available from the Council (see ADDRESSES ). This final rule has been determined to be significant for purposes of Executive Order 12866. The final regulatory flexibility analysis
(FRFA)consists of the IRFA. No comments were received on the IRFA or on the economic impacts of this rule. A copy of this analysis is available from the Council (see ADDRESSES ). The FRFA describes the economic impact this final rule, if adopted, would have on small entities. A description of the action, why it is being considered, and the legal basis for this action are contained at the beginning of this section in the preamble and in the SUMMARY section of the preamble. A summary of the analysis follows. Commercial salmon harvesting vessels buyers/processors, and charter/party boats are expected to be the only type of small entities directly impacted by the proposed action. Section 603 (b)(1)-(5) of the RFA identifies the elements that should be included in the IRFA. These elements are bulleted below, followed by information that addresses each element. •Description of the reasons why action by the agency is being considered: This action is needed to prevent fishery restrictions that impose severe economic consequences to local communities and states. Historically, KRFC was a primary contributor to marine fisheries off the coasts of Oregon and California. While the FMP amendment seeks to provide management flexibility in times of scarcity, there is an overriding purpose to preserve the long-term productive capacity of the stock to ensure meaningful contributions to ocean and river fisheries in the future. •Statement of the objectives of, and legal basis for, the final rule: The Salmon FMP directs ocean salmon fishery management actions relative to the exclusive economic zone(EEZ) off the coasts of Washington, Oregon, and California. Under the existing Salmon FMP, a preseason projection that the conservation floor for KRFC will not be met triggers a Conservation Alert, which provides the Council and NMFS only one option: to close all salmon fisheries within its jurisdiction that impact the stock. These fisheries include ocean salmon fisheries between Cape Falcon, Oregon and Point Sur, California. Currently, any other option can only be addressed through the emergency regulation process as provided in the Magnuson-Steven Act
(MSA)and implemented by NMFS. The purpose of Amendment 15 is two-fold:
(1)to give more flexibility to the management process when the escapement floor of 35,000 natural spawners for KRFC is projected not to be met; and
(2)to provide for appropriate opportunities to access more robust Chinook salmon stocks that are typically available in the Council managed area. This rule would, in appropriate circumstances, allow for the Council to develop and recommend fisheries, and NMFS to implement fisheries without the need for an emergency rule in years when the abundance of KRFC are low. •Description of and an estimate of the number of small entities to which the final rule would apply: The small entities that would be affected by the proposed action are the vessels that compose the California and Oregon commercial salmon troll fleet and buyers/processors, the charter/party boat fleet between Cape Falcon, Oregon, and Point Sur, California, and other fishery dependent businesses. In years with sufficient surplus, the Yurok and Hoopa Valley Tribes sell salmon in excess of their subsistence needs. The generally acknowledged minimum tribal subsistence need is about 12,000 KRFC. In years that a Conservation Alert is triggered, it is unlikely the tribal share would exceed 12,000 KRFC. Therefore, no analysis of the tribal fishery is included in the IRFA. Salmon Troll Fleet The financial impacts analysis focuses on the ex-vessel revenue effects of each alternative on salmon troll vessels. Financial impacts were evaluated based only on changes in salmon ex-vessel revenues relative to the Status Quo Alternative. Vessel counts are based on unique vessel identifiers. However, it is known that in many cases a single firm may own more than one vessel; therefore, the counts should be considered upper bound estimates. Additionally, businesses owning vessels may have revenue from fisheries in other geographic areas, such as Alaska, or from non-salmon fishing activities. Therefore, it is likely that when all operations of a firm are aggregated, some of the small entities identified here are actually larger than indicated. Approximately 2,718 vessels were permitted to operate in the commercial salmon troll fisheries in Oregon and/or California in 2005, although the active fleet was considerably smaller, with an average of approximately 1,068 vessels participating in 2003-2005. In addition, only about 13-19 percent of the active fleet landed 50 percent of the catch, and 52-55 percent of the fleet landed 90 percent of the catch in those years (STT 2006a). Of the 1,068 vessels, 40 percent participated only in salmon fisheries, while the other 60 percent participated in multiple fisheries. All of these vessels would be considered small businesses under the SBA standards. The active fleet participation is dynamic with respect to annual opportunity in the salmon fishery. In years with less opportunity, some salmon vessels choose not to participate, and either engage in other fisheries or sell out. In years with more opportunity, previously inactive vessels may choose to participate, or may be sold to more active fishermen. Under the Status Quo Alternative, there would be no participation in the commercial salmon fishery between Cape Falcon, Oregon and Point Sur, California during years that a Conservation Alert was triggered. Under the fixed cap alternatives, the active fleet was projected to be approximately 268 to 354. The 2003-2005 average salmon related revenue per troll vessel was estimated at $20,900. For salmon only troll vessels the average was $14,300 and for multiple species troll vessels the average was $25,200. Under the fixed cap alternatives, the average salmon-related revenue was projected at $1.6 million to 3.1 million in a Conservation Alert Year and applying a medium troller success rate scenario. Processors/Buyers A relatively small number of large processor/buyer firms handle most of the ocean salmon catch on the West Coast. There were 464 firms with state processor/buyer licenses that sold salmon in Oregon and California in 2004 (PFMC and NMFS 2006). These firms include both operators of processing plants and buyers that may do little more than hold the fish prior to their shipment to a processor or market. In some cases, the buyers may be owners of vessels who also own licenses allowing them to sell fish directly to the public or retail markets. Most larger salmon buying firms acquire fish from sites in more than one port. The largest salmon buyers tend to buy salmon from many vessels and buy fish in several ports. The top ocean caught salmon buying firms include some firms that are not among the top fish buyers when all species are counted. Larger processing firms are more likely to handle ocean caught salmon than smaller firms. However, there are many small buyers that specialize in salmon, only handle small amounts of product, and receive product from one or two vessels. It is likely that most of these buyers are vessels that also have licenses allowing them to sell directly to the public or other retail outlets(e.g., restaurants). A thorough analysis of the effects of the Preferred Alternative would include estimates of the numbers of vessels acting as buyers/processors, as well as other buyer/processor sectors, the recent history of revenue generated by the various classes of buyer/processors, and a projection of revenue generated under the Status Quo and Preferred alternatives in Conservation Alert years. However, because many of the small business buyer/processors include vessel ownership, and because most buyer/processors deal in multiple fisheries, it is likely the effects of the Preferred Alternative are proportional to those estimated and projected for the salmon troll fleet above. Charter/Party Boats Approximately 103 charter boats participated in California recreational ocean salmon fisheries in 2003-2005 (STT 2006a). In Oregon, there was an average of 211 licensed charter vessels during these same years. An estimated 6 percent of the Oregon charter effort occurred in the Astoria area during 2003-2005 (STT 2006a). In Oregon there was an average of 211 licensed charter vessels. There was no information available for port of operation for Oregon charter vessels, but an average of 18 percent of Oregon charter based salmon trips originated in the Astoria area. There was also no information available on fishery participation for Oregon vessels, and some may not have engaged in salmon fishing. Conversely, it is likely that most of the Charter fleet in both states participated in fisheries other than salmon, such as California halibut, Pacific Halibut, bottomfish, and albacore. Separate economic impact estimates were not available for charter and private boat salmon fishing sectors; however during 2003-2005, Oregon and California recreational salmon fishing effort averaged 297,200 angler trips for both boat types, with charter boat fishing averaging 31 percent of the total during. Based on this assumption the projected state level income impact of the *de minimis* fishery alternatives under the fixed cap alternatives in a Conservation Alert Year ranged from $6.2 million to $6.8 million dollars. For the Status Quo Alternative the economic impact was about $322,000. Based on an assumed fleet of 314 vessels, the average economic impact per vessel was about $3,200 for the Status Quo Alternative and $19,700 to $21,700 annually for the fixed cap alternatives. Other Small Businesses In addition to commercial fishing vessels, other fishery-dependent businesses that may be affected include suppliers, buyers who act as intermediaries between vessels and consumers, processors who purchase raw materials from commercial vessels to produce seafood products, and charter or party vessels that provide recreational fishing experience for paying customers, among others. A thorough accounting of net benefits would include measurement of producer surpluses accruing to these business sectors as well as to fishing vessels. •A description of the projected reporting, record-keeping, and other compliance requirements of the final rule, including an estimate of the classes of small entities that will be subject to the requirements of the report or record: There were no new reporting or record-keeping requirements that are proposed as part of this final rule. •An identification, to the extent practicable, of all relevant Federal rules, which may duplicate, overlap, or conflict with the final rule: No Federal rules have been identified that duplicate, overlap, or conflict with the alternatives. •A description of any significant alternatives to the final rule that accomplish the stated objectives that would minimize any significant economic impact of the final rule on small entities: The decision to set the *de minimis* harvest rate cap at 10 percent was determined through the consideration of ecological, fishery, and economic effects of each alternative. It should be noted that modification of the current 35,000 naturally spawning adult floor to some other value would not address the issue of *de minimis* fishing opportunity in low abundance years, which is a primary reason for approval of Amendment 15 to the FMP. The Council was presented with modeling results from the Salmon Amendment Committee
(SAC)at its September 2006 meeting which examined each of the alternatives. These results showed little difference in long term effects on the stock size between each of the proposed alternatives. Differences among the de minimis alternatives (status quo, 5 percent, 10 percent, 13 percent) in terms of aggregate salmon troll revenues and associated income impacts indicated little difference among the alternatives in terms of long-term economic effects. The alternatives, however, indicated more substantial differences when the analysis focused on fishery outcomes in Conservation Alert years. The 13 percent alternative showed a higher probability of the age-4 ocean harvest rate going above 16 percent, which is the Endangered Species Act
(ESA)Consultation Standard for threatened California Coastal Chinook. The 13 percent alternative also showed a higher probability of reducing the tributary spawning escapement below 720, which is considered to be a crucial genetic threshold. The 5 percent and the status quo alternatives were also examined and while they would both be a lower catch limit than the 10 percent and 13 percent alternatives they would provide little in the way of economic benefit to the fishery. The 10 percent alternative was chosen because it will not impact the long term productivity of the stock, especially when provisions are set to reduce the cap as needed and it provides some economic relief to the fishery. The model projections showed that the 10 percent alternative would allow for more fishing days, a higher catch of KRFC and a higher revenue than the 5 percent alternative. This rule provides authority under certain circumstances for *de minimis* fisheries. The specific impacts of annual measures will be assessed annually during the development of annual measures. Additionally, the specific impacts of any de minimis fisheries pursuant to the authority of Amendment 15 will be assessed at that time. Since 1989, NMFS has listed 27 ESUs of salmonids on the West Coast. As the listings have occurred, NMFS has conducted formal ESA section 7 consultations and issued biological opinions, and made determinations under section 4(d) of the ESA, that consider the impacts to listed salmonid species resulting from proposed implementation of the Salmon FMP, or in some cases, from proposed implementation of the annual management measures. Associated with the biological opinions are incidental take statements that specify the level of take that is expected. Some of the biological opinions have concluded that implementation of the Salmon FMP is not likely to jeopardize the continued existence of certain listed salmonid ESUs and provide incidental take statements. Other biological opinions have found that implementation of the Salmon FMP is likely to jeopardize certain listed ESUs and have identified reasonable and prudent alternatives (consultation standards) that would avoid the likelihood of jeopardizing the continued existence of the ESU under consideration, and provided an incidental take statement for the reasonable and prudent alternative. NMFS has determined that fishing activities conducted pursuant to this final rule will affect endangered and threatened species and critical habitat under the ESA but will not jeopardize the continued existence of those species. NMFS will continue to assess the impact of the fishery each year during the development of annual measures. The West Coast ocean salmon fisheries are considered a Category III fishery under the Marine Mammal Protection Act, indicating a remote likelihood of or no known serious injuries or mortalities to marine mammals, in the annual list of fisheries published in the **Federal Register** . Based on its Category III status, the incidental take of marine mammals in the West Coast salmon fisheries does not significantly impact marine mammal stocks. Amendment 15 was developed by the Council, which includes a tribal representative who proposed no objections to the Amendment before NMFS's approval. Klamath River tribes with federally recognized fishing rights may be impacted by Council area fisheries. NMFS notified the Yurok and Hoopa Tribes regarding the changes in this final rule from the proposed rule. In addition, as discussed above the Yurok Tribe submitted comments on the proposed rule. In consideration of those comments NMFS modified the regulatory text in this final rule. List of Subjects in 50 CFR Part 660 Fisheries, Fishing, Reporting and recordkeeping requirements. Dated: February 7, 2008. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service. For the reason set out in the preamble, NMFS amend 50 CFR part 660 as follows: PART 660—FISHERIES OFF WEST COAST STATES 1. The authority for part 660 continues to read as follows: Authority: 16 U.S.C. 1801 *et seq.* 2.In § 660.410 revise paragraph (b)(1) and add paragrpah
(d)to read as follows: § 660.410 Conservation objectives.
(b)* * *
(1)A comprehensive technical review of the best scientific information available provides conclusive evidence that, in the view of the Council, the Scientific and Statistical Committee, and the Salmon Technical Team, justifies modification of a conservation objective: except that the 35,000 natural spawner floor and the *de minimis* fishing provisions for Klamath River fall Chinook may be changed only by amendment.
(d)Within the Cape Falcon to Point Sur area, the Council may allow de minimis fisheries which: permit an ocean impact rate of no more than 10 percent on age-4 Klamath River fall Chinook, if the projected natural spawning escapement associated with a 10 percent age-4 ocean impact rate, including river recreational and tribal impacts, is between the conservation objective (35,000) and 22,000. If the projected natural escapement associated with a 10 percent age-4 ocean impact rate is less than 22,000, the Council shall further reduce the allowable age-4 ocean impact rate to reflect the status of the stock. 1 1 NMFS interprets that, consistent with the *de minimis* provisions of the FMP, the maximum allowable 10 percent age-4 ocean impact rate may be implemented only when the anticipated escapement is near the 35,000 natural spawner floor. As escapement falls below approximately 30,000, the impact rate will need to decline automatically. (1)When recommending an allowable age-4 ocean impact rate, the Council shall consider the following year specific circumstances: (i)The potential for critically low natural spawner abundance, including the risk of Klamath Basin substocks dropping below crucial genetic thresholds;
(ii)A series of low spawner abundance in recent years;
(iii)The status of co-mingled stocks;
(iv)The occurrence of El Nino or other adverse environmental conditions;
(v)Endangered Species Act
(ESA)considerations; and
(vi)Other considerations as appropriate.
(2)The Klamath River fall Chinook age-4 ocean impact rate must not jeopardize the long term capacity of the stock to produce maximum sustainable yield on continuing basis. [FR Doc. E8-3348 Filed 2-22-08; 8:45 am] BILLING CODE 3510-22-S 73 37 Monday, February 25, 2008 Proposed Rules DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 930 [Docket No. AMS-FV-07-0137; FV08-930-1] Tart Cherries Grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin; Continuance Referendum AGENCY: Agricultural Marketing Service, USDA. ACTION: Referendum order. SUMMARY: This document directs that a continuance referendum be conducted among eligible growers and processors of tart cherries in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin to determine whether they favor continuance of the marketing order regulating the handling of tart cherries grown in the production area. DATES: The referendum will be conducted from March 17 through March 31, 2008. To vote in this referendum, growers and processors must have been engaged in producing or processing tart cherries within the production area during the period July 1, 2006, through June 30, 2007. ADDRESSES: Copies of the marketing order may be obtained from USDA, Washington DC Marketing Field Office, 4700 River Road, Unit 155, Riverdale, Maryland 20737, or the Office of the Docket Clerk, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., Stop 0237, Washington, DC 20250-0237. FOR FURTHER INFORMATION CONTACT: Patricia A. Petrella or Kenneth G. Johnson, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, Unit 155, 4700 River Road, Riverdale, MD 20737; telephone:
(301)734-5243, Fax:
(301)734-5275, or E-mail: *Patricia.Petrella@usda.gov* or *Kenneth.Johnson@usda.gov.* SUPPLEMENTARY INFORMATION: Pursuant to Marketing Order No. 930 (7 CFR part 930), hereinafter referred to as the “order,” and the applicable provisions of the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act,” it is hereby directed that a referendum be conducted to ascertain whether continuance of the order is favored by growers and processors. The referendum shall be conducted during the period March 17 through March 31, 2008, among eligible tart cherry growers and processors in the production area. Only growers and processors that were engaged in the production or processing of tart cherries in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin during the period of July 1, 2006, through June 30, 2007, may participate in the continuance referendum. USDA has determined that continuance referenda are an effective means for determining whether growers and processors favor continuation of marketing order programs. USDA would consider termination of the order if continuance is favored by fewer than 50 percent of the growers and processors who vote in the referendum, and growers and processors of less than 50 percent of the volume of tart cherries represented in the referendum favor continuance. In evaluating the merits of continuance versus termination, USDA will consider the results of the continuance referendum and other relevant information concerning the operation of the order. USDA will evaluate the order's relative benefits and disadvantages to growers, processors, and consumers in order to determine whether continued operation of the order would tend to effectuate the declared policy of the Act. In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the ballot materials used in the referendum herein ordered are currently approved by the Office of Management and Budget
(OMB)under OMB No. 0581-0177, Tart Cherries Grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington and Wisconsin. It has been estimated that it will take an average of 20 minutes for each of the approximately 40 processors and 900 growers of tart cherries in the production area to cast a ballot. Participation is voluntary. Ballots postmarked after March 31, 2008, will be marked invalid and not included in the vote tabulation. Kenneth G. Johnson, Patricia A. Petrella, and Dawana Clark of the Washington, DC, Marketing Field Office, Fruit and Vegetable Programs, Agricultural Marketing Service, USDA, are hereby designated as the referendum agents of the Secretary of Agriculture to conduct such referendum. The procedure applicable to the referendum shall be the “Procedure for the Conduct of Referenda in Connection With Marketing Orders for Fruits, Vegetables, and Nuts Pursuant to the Agricultural Marketing Agreement Act of 1937, as Amended” (7 CFR 900.400 *et seq.* ). Ballots will be mailed to all growers and processors of record and may also be obtained from the referendum agents and from their appointees. List of Subjects in 7 CFR Part 930 Tart Cherries, Marketing agreements, Reporting and recordkeeping requirements. Authority: 7 U.S.C. 601-674. Dated: February 19, 2008. Lloyd C. Day, Administrator, Agricultural Marketing Service. [FR Doc. E8-3494 Filed 2-22-08; 8:45 am] BILLING CODE 3410-02-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0197; Directorate Identifier 2008-CE-005-AD] RIN 2120-AA64 Airworthiness Directives; Dornier Luftfahrt GmbH Models 228-100, 228-101, 228-200, 228-201, 228-202, and 228-212 Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: We propose to adopt a new airworthiness directive
(AD)for the products listed above. This proposed AD results from mandatory continuing airworthiness information
(MCAI)originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: The manufacturer reported findings of missing primer on the internal of the elevator and rudder of aircraft S/N 8200. The aircraft S/N 8200 was with RUAG for maintenance purposes. Investigation performed by RUAG showed that the paint removal procedure for the rudder and elevator was changed from a paint stripping with brush and scraper to a procedure where the parts were submerged in a tank filled with hot liquid stripper. The stripper is called TURCO 5669 from Henkel Surface Technologies. The stripping process is described in the Technical Process Bulletin No. 238799 dated 09/01/1999. This paint stripping process change was not communicated to and not approved by the TC-Holder. The proposed AD would require actions that are intended to address the unsafe condition described in the MCAI. DATES: We must receive comments on this proposed AD by March 26, 2008. ADDRESSES: You may send comments by any of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov.* Follow the instructions for submitting comments. • *Fax:*
(202)493-2251. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Hand Delivery:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.gov;* or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone
(800)647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. FOR FURTHER INFORMATION CONTACT: Karl Schletzbaum, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone:
(816)329-4146; fax:
(816)329-4090. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2008-0197; Directorate Identifier 2008-CE-005-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments. We will post all comments we receive, without change, to *http://www.regulations.gov,* including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD. Discussion The Luftfahrt-Bundesamt (LBA), which is the airworthiness authority for Germany, has issued German AD D-2007-350, dated December 19, 2007 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states: The manufacturer reported findings of missing primer on the internal of the elevator and rudder of aircraft S/N 8200. The aircraft S/N 8200 was with RUAG for maintenance purposes. Investigation performed by RUAG showed that the paint removal procedure for the rudder and elevator was changed from a paint stripping with brush and scraper to a procedure where the parts were submerged in a tank filled with hot liquid stripper. The stripper is called TURCO 5669 from Henkel Surface Technologies. The stripping process is described in the Technical Process Bulletin No. 238799 dated 09/01/1999. This paint stripping process change was not communicated to and not approved by the TC-Holder. The MCAI requires you to do a visual inspection of the inner structure of the rudder and elevator for signs of corrosion, debonded primer (yellow-green), and any other deviation of surface protection; report corrosion beyond the acceptable level or areas with debonded primer to the manufacturer; and, if necessary, repair the affected parts following the applicable FAA-approved manufacturer repair instruction. You may obtain further information by examining the MCAI in the AD docket. Relevant Service Information RUAG Aerospace Defence Technology has issued Dornier 228 Service Bulletin No. SB-228-270, dated October 30, 2007. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI. FAA's Determination and Requirements of the Proposed AD This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design. Differences Between This Proposed AD and the MCAI or Service Information We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information. We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the proposed AD. Costs of Compliance Based on the service information, we estimate that this proposed AD would affect about 8 products of U.S. registry. We also estimate that it would take about 3 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $1,920, or $240 per product. We have no way of determining the number of products that may need any necessary follow-on actions. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify this proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new AD: **Dornier Luftfahrt GmbH:** Docket No. FAA-2008-0197; Directorate Identifier 2008-CE-005-AD. Comments Due Date
(a)We must receive comments by March 26, 2008. Affected ADs
(b)None. Applicability
(c)This AD applies to Models 228-100, 228-101, 228-200, 228-201, 228-202, and 228-212 airplanes, serial numbers 8009, 8065, 8112, 8179, 8185, 8191, 8241, and 8244, certificated in any category. Subject
(d)Air Transport Association of America
(ATA)Code 51: Structures. Reason
(e)The mandatory continuing airworthiness information
(MCAI)states: “The manufacturer reported findings of missing primer on the internal of the elevator and rudder of aircraft S/N 8200. The aircraft S/N 8200 was with RUAG for maintenance purposes. Investigation performed by RUAG showed that the paint removal procedure for the rudder and elevator was changed from a paint stripping with brush and scraper to a procedure where the parts were submerged in a tank filled with hot liquid stripper. The stripper is called TURCO 5669 from Henkel Surface Technologies. The stripping process is described in the Technical Process Bulletin No. 238799 dated 09/01/1999. This paint stripping process change was not communicated to and not approved by the TC-Holder.” The MCAI requires you to do a visual inspection of the inner structure on rudder and elevator for signs of corrosion, de-bonded primer (yellow-green), and any other deviation of surface protection; report corrosion beyond the acceptable level or areas with de-bonded primer to the manufacturer; and, if necessary, repair the affected parts following the applicable FAA-approved manufacturer repair instruction. Actions and Compliance
(f)Unless already done, do the following actions:
(1)Within 2 months after the effective date of this AD, do a detailed visual inspection on the inner structure of the rudder and elevator for signs of corrosion, de-bonded primer (yellow-green), and any other deviation of surface protection following RUAG Aerospace Defence Technology Dornier 228 Service Bulletin No. SB-228-270, dated October 30, 2007.
(2)If you find corrosion or areas with debonded primer as a result of the inspection required by paragraph (f)(1) of this AD, before further flight, do the following:
(i)Report the inspection results to RUAG Aerospace Services GmbH, Dornier 228 Customer Support, P.O. Box 1253, 82231 Wessling, Federal Republic of Germany, telephone: +49 (0)8153-30-2280; fax: +49
(0)8153-30-3030 and request FAA-approved repair instructions following RUAG Aerospace Defence Technology Dornier 228 Service Bulletin No. SB-228-270, dated October 30, 2007.
(ii)Repair corrosion following FAA-approved repair instructions obtained from RUAG Aerospace Services GmbH. FAA AD Differences Note: This AD differs from the MCAI and/or service information as follows: The MCAI includes provisions for reporting corrosion “beyond the acceptable level.” However, the service information does not include a definition of “acceptable level.” Therefore, to ensure the AD is clear for U.S. operators and is enforceable, this AD does not include the qualifier “beyond the acceptable level.” Other FAA AD Provisions
(g)The following provisions also apply to this AD:
(1)*Alternative Methods of Compliance (AMOCs):* The Manager, Standards Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Karl Schletzbaum, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone:
(816)329-4146; fax:
(816)329-4090. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
(2)*Airworthy Product:* For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.
(3)*Reporting Requirements:* For any reporting requirement in this AD, under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 *et seq.* ), the Office of Management and Budget
(OMB)has approved the information collection requirements and has assigned OMB Control Number 2120-0056. Related Information
(h)Refer to MCAI German AD D-2007-350, dated December 19, 2007; and RUAG Aerospace Defence Technology Dornier 228 Service Bulletin No. SB-228-270, dated October 30, 2007, for related information. Issued in Kansas City, Missouri, on February 13, 2008. David R. Showers, Acting Manager, Small Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-3407 Filed 2-22-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0196; Directorate Identifier 2008-CE-002-AD] RIN 2120-AA64 Airworthiness Directives; APEX Aircraft Model CAP 10 B Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: We propose to adopt a new airworthiness directive
(AD)for the products listed above that would supersede an existing AD. This proposed AD results from mandatory continuing airworthiness information
(MCAI)originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: Further to a new fracture in flight of a CAP 10B wing in June 2003, the investigation in process seems to point out that a wrong application of CAP 10B Service Bulletin No. 16 (CAP 10B-57-004) would lead to the impossibility of detecting the potential spar damage while performing the Type Certificate holder upper spar flange inspection. The proposed AD would require actions that are intended to address the unsafe condition described in the MCAI. DATES: We must receive comments on this proposed AD by March 26, 2008. ADDRESSES: You may send comments by any of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov.* Follow the instructions for submitting comments. • *Fax:*
(202)493-2251. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Hand Delivery:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.gov;* or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone
(800)647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. FOR FURTHER INFORMATION CONTACT: Sarjapur Nagarajan, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone:
(816)329-4145; fax:
(816)329-4090. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2008-0196; Directorate Identifier 2008-CE-002-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments. We will post all comments we receive, without change, to *http://regulations.gov* , including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD. Discussion On February 4, 2003, we issued AD 2003-04-02, Amendment 39-13050 (68 FR 7904; February 19, 2003). That AD required actions intended to address an unsafe condition on the products listed above. Since we issued AD 2003-04-02, another wing of a Model CAP 10 B airplane cracked in flight. The Direction Générale de L'Aviation Civile (DGAC), which is the aviation authority for France, has issued AD 2003-375(A), dated October 1, 2003 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states: Further to a new fracture in flight of a CAP 10B wing in June 2003, the investigation in process seems to point out that a wrong application of CAP 10B Service Bulletin No. 16 (CAP 10B-57-004) would lead to the impossibility of detecting the potential spar damage while performing the Type Certificate holder upper spar flange inspection. The MCAI requires you to check that the No. 1 wing rib has been modified, comply with load factors and operating limitations, and do repetitive inspections of the upper and lower spar flanges and landing gear attachment blocks. We are proposing to add new actions, retain actions from AD 2003-04-02, and change the applicability (reduce the number) of the airplanes. You may obtain further information by examining the MCAI in the AD docket. Relevant Service Information APEX Aircraft has issued Avions Mudry & CIE Service Bulletin CAP10B No. 16, dated April 27, 1992; APEX Aircraft Document No. 1000913GB, dated February 4, 2002; APEX Aircraft Document No. 1000914GB, dated February 4, 2002; and APEX Aircraft Document No. 1000915GB, dated February 4, 2002. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI. FAA's Determination and Requirements of the Proposed AD This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design. Differences Between This Proposed AD and the MCAI or Service Information We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information. We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the proposed AD. Costs of Compliance Based on the service information, we estimate that this proposed AD would affect about 31 products of U.S. registry including those airplanes affected by AD 2003-04-02. We also estimate that it would take about 20 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $49,600, or $1,600 per product. The estimated total cost on U.S. Operators includes the cumulative costs associated with those airplanes affected by AD 2003-04-02 and those costs associated with the lesser number of airplanes and the new actions that would be added in this proposed AD. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify this proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by removing Amendment 39-13050 (68 FR 7804; February 19, 2003), and adding the following new AD: **APEX Aircraft:** Docket No. FAA-2008-0196; Directorate Identifier 2008-CE-002-AD. Comments Due Date
(a)We must receive comments by March 26, 2008. Affected ADs
(b)This AD supersedes AD 2003-04-02, Amendment 39-13050. Applicability
(c)This AD applies to Model CAP 10 B airplanes, serial numbers
(SNs)01, 02, 03, 04, and 1 through 282, certificated in any category, which have not been fitted with a replacement wood/carbon wing following application of major change 000302. Subject
(d)Air Transport Association of America
(ATA)Code 57: Wings. Reason
(e)The mandatory continuing airworthiness information
(MCAI)states: “Further to a new fracture in flight of a CAP 10B wing in June 2003, the investigation in process seems to point out that a wrong application of CAP 10B Service Bulletin No. 16 (CAP 10B-57-004) would lead to the impossibility of detecting the potential spar damage while performing the Type Certificate holder upper spar flange inspection.'' The MCAI requires you to check that the No. 1 wing rib has been modified, comply with load factors and operating limitations, and do repetitive inspections of the upper and lower spar flanges and landing gear attachment blocks. Restatement of Requirements of AD 2003-04-02
(f)Unless already done, do the following actions:
(1)For Model CAP 10 B airplanes with SNs 01, 02, 03, 04, and 1 through 263, within the next 100 hours time-in-service
(TIS)after July 23, 1993 (the compliance date retained from AD 2003-04-02), unless already done, install a permanent inspection opening in the No. 1 wing rib following Avions Mudry Service Bulletin CAP10B No. 16, dated April 27, 1992. Inspection openings are incorporated during production for airplanes having a serial number of 264 or higher.
(2)For all affected airplanes, initially inspect the upper wing spar cap, the main wing spar undersurface, and the landing gear attachment blocks for cracks within the next 55 hours TIS after April 4, 2003 (the compliance date retained from AD 2003-04-02) following APEX Aircraft Document No. 1000913GB, dated February 4, 2002; APEX Aircraft Document No. 1000914GB, dated February 4, 2002; and APEX Aircraft Document No. 1000915GB, dated February 4, 2002. Repetitively inspect the upper wing spar cap and the main wing spar undersurface thereafter at intervals not to exceed 55 hours TIS. Repetitively inspect the landing gear attachment blocks thereafter at intervals not to exceed 1,000 hours TIS.
(3)For all affected airplanes, before further flight if any cracks are found during any inspection required in paragraph (f)(2) of this AD, do the following:
(i)Obtain a repair scheme from the manufacturer through the FAA at the address specified in paragraph (h)(1) of this AD;
(ii)Incorporate this repair scheme; and
(iii)Continue to inspect as specified in paragraph (f)(2) of this AD. New Requirements of This AD: Actions and Compliance
(g)Unless already done, do the following actions:
(1)*Load factors limitation:* Before further flight, as of the effective date of this AD, the load factors limitation for solo flight is +5 and −3.5 Gs and when 2 persons are on board is +4.3 and −3.5 Gs.
(2)*Flick (snap roll) maneuvers speed limitation:* Before further flight, as of the effective date of this AD, for positive and negative flick maneuvers, the airspeed limitation is 160 km/hour (86 knots).
(3)Fabricate a placard that incorporates the following words (using at least 1/8-inch letters) and install this placard on the instrument panel within the pilot's clear view: “THE NEVER EXCEED AIRSPEED FOR POSITIVE OR NEGATIVE FLICK MANEUVERS IS 160 KM/H (86 KNOTS). THE LOAD FACTORS LIMITATION FOR SOLO FLIGHT IS +5 AND −3.5 Gs AND WHEN 2 PERSONS ARE ON BOARD IS +4.3 AND −3.5 Gs.” FAA AD Differences Note: This AD differs from the MCAI and/or service information as follows: This AD does not include the requirement from the MCAI to route the request to operate beyond the load factors limitation and flick (snap roll) maneuvers speed limitation through the DGAC. You may make this request to the FAA following paragraph (h)(1) of this AD. Other FAA AD Provisions
(h)The following provisions also apply to this AD:
(1)*Alternative Methods of Compliance (AMOCs):* The Manager, Standards Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Sarjapur Nagarajan, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone:
(816)329-4145; fax:
(816)329-4090. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
(2)*Airworthy Product:* For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.
(3)*Reporting Requirements:* For any reporting requirement in this AD, under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 *et seq* .), the Office of Management and Budget
(OMB)has approved the information collection requirements and has assigned OMB Control Number 2120-0056. Related Information
(i)Refer to MCAI French AD 2003-375(A), dated October 1, 2003; Avions Mudry & CIE Service Bulletin CAP10B No. 16, dated April 27, 1992, APEX Aircraft Document No. 1000913GB, dated February 4, 2002; APEX Aircraft Document No. 1000914GB, dated February 4, 2002; and APEX Aircraft Document No. 1000915GB, dated February 4, 2002, for related information. Issued in Kansas City, Missouri, on February 14, 2008. David R. Showers, Acting Manager, Small Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-3411 Filed 2-22-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-0242; Directorate Identifier 2007-NE-51-AD] RIN 2120-AA64 Airworthiness Directives; General Electric Company CF6-80C2 and CF6-80E1 Series Turbofan Engines AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: The FAA proposes to adopt a new airworthiness directive
(AD)for General Electric Company
(GE)CF6-80C2 and CF6-80E1 series turbofan engines. This proposed AD would require replacement of all clevis pins installed on the thrust reverser central drive units and upper and lower actuators, or replacement of pins that fail an on-wing rebound hardness test. This proposed AD results from failure of a thrust reverser during landing due to unapproved clevis pins being installed. The failure was due to lack of clevis pin hardness. We are proposing this AD to prevent thrust reverser failure, which could lead to damage to the thrust reverser and airplane. DATES: We must receive any comments on this proposed AD by April 25, 2008. ADDRESSES: Use one of the following addresses to comment on this proposed AD. • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov* and follow the instructions for sending your comments electronically. • *Mail:* Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001. • *Hand Delivery:* Deliver to Mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. • *Fax:*
(202)493-2251. FOR FURTHER INFORMATION CONTACT: Christopher Richards, Aerospace Engineer, Engine Certification Office, FAA, Engine and Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; e-mail: *Christopher.j.richards@faa.gov;* telephone:
(781)238-7133, fax:
(781)238-7199. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to send us any written relevant data, views, or arguments regarding this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2007-0242; Directorate Identifier 2007-NE-51-AD” in the subject line of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. We will consider all comments received by the closing date and may amend the proposed AD in light of those comments. We will post all comments we receive, without change, to *http://www.regulations.gov,* including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this proposed AD. Using the search function of the Web site, anyone can find and read the comments in any of our dockets, including, if provided, the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477-78). Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.gov;* or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone
(800)647-5527) is the same as the mail address provided in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. Discussion In January 2007, an MD-11 airplane landed with one actuator on a thrust reverser inoperative. When a single actuator is inoperative, the thrust reversers are designed to continue normal operation until the next inspection. Upon landing, the thrust reversers deployed and two of the clevis pins failed on the thrust reverser with one actuator inoperative. These failures caused a transcowl to separate from the thrust reverser damaging the thrust reverser and airplane, and causing the transcowl to become hazardous debris on the runway. Investigation revealed that: • The lower actuator on the affected thrust reverser had failed some time before the incident; and • Of the three thrust reverser central drive unit clevis pins affected, one clevis pin was found sheared in half, with part of the pin still in place in the rod-end bearing and clevis. The pin was an unapproved part, made of carbon steel alloy, which had too low a strength and hardness for this application. • One of the clevis pins remained installed, and was found to be an approved part clevis pin and with the correct hardness of 31 to 38 Rockwell Hardness (C Scale). • The third clevis pin was not found. This condition, if not corrected, could result in thrust reverser failure, which could lead to damage to the thrust reverser and airplane. FAA's Determination and Requirements of the Proposed AD We have evaluated all pertinent information and identified an unsafe condition that is likely to exist or develop on other products of this same type design. We are proposing this AD, which would require replacement of all clevis pins installed on the thrust reverser central drive units and upper and lower actuators, or replacement of pins that fail a rebound hardness test. Costs of Compliance We estimate that this proposed AD would affect 802 CF6-80C2 series turbofan engines installed on airplanes of U.S. registry. We also estimate that it would take about one work-hour per engine to perform the proposed rebound hardness test and three work-hours per engine to replace the six pins. The average labor rate is $80 per work-hour. Pins cost about $144 per pin. If all pins are replaced, we estimate the total cost of the proposed AD to U.S. operators to be $949,568. CF6-80E1 series turbofan engines are not currently installed on U.S. registered airplanes, so we did not estimate any cost for them. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that the proposed AD: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD. You may get a copy of this summary at the address listed under ADDRESSES . List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Under the authority delegated to me by the Administrator, the Federal Aviation Administration proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new airworthiness directive: **General Electric Company:** Docket No. FAA-2007-0242; Directorate Identifier 2007-NE-51-AD. Comments Due Date
(a)The Federal Aviation Administration
(FAA)must receive comments on this airworthiness directive
(AD)action by April 25, 2008. Affected ADs
(b)None. Applicability
(c)This AD applies to General Electric Company
(GE)CF6-80C2 and CF6-80E1 series turbofan engines. These engines are installed on, but not limited to, Airbus A300-600/R/F, A310-200/-300, and A330-200/-300 airplanes, Boeing 747-300/-400/-400ER, and 767-200/-200ER/-300/-300ER/-400ER airplanes, and MD-11 airplanes. Unsafe Condition
(d)This AD results from failure of a thrust reverser during landing due to unapproved clevis pins being installed. The failure was due to lack of clevis pin hardness. We are issuing this AD to prevent thrust reverser failure, which could lead to damage to the thrust reverser and airplane. Compliance
(e)You are responsible for having the actions required by this AD performed within 18 months or 4,500 flight hours after the effective date of this AD, whichever occurs first, unless the actions have already been done.
(f)Replace the six clevis pins installed on the thrust reverser central drive units and actuators with clevis pins that pass the hardness test identified in paragraphs (g)(1) through (g)(4) below; or
(g)Perform a rebound hardness test of installed thrust reverser central drive unit and actuator clevis pins as follows:
(1)Remove any corrosion from the head of the pin.
(2)Perform the rebound hardness test on the head of the clevis pin.
(3)If the hardness measured is outside of the range of 31 to 38 Rockwell Hardness (C Scale), replace the clevis pin with an approved part clevis pin.
(4)If the hardness measured is within the range of 31 to 38 Rockwell Hardness (C Scale), and the pin has no visible defects, the clevis pin can remain in service, as allowed per the engine maintenance manual.
(5)Perform the steps in paragraphs (g)(1) through (g)(4) to all six clevis pins on the thrust reverser. Install Approved Part Clevis Pins
(h)After the effective date of this AD, do not install any thrust reverser central drive unit and actuator clevis pins that do not pass the hardness test of paragraphs (g)(1) through (g)(4) of this AD. Alternative Methods of Compliance
(i)The Manager, Engine Certification Office, has the authority to approve alternative methods of compliance for this AD if requested using the procedures found in 14 CFR 39.19. Related Information
(j)Contact Christopher Richards, Aerospace Engineer, Engine Certification Office, FAA, Engine and Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; e-mail: *Christopher.richards@faa.gov;* telephone:
(781)238-7133, fax:
(781)238-7199, for more information about this AD. Issued in Burlington, Massachusetts, on February 15, 2008. Peter A. White, Assistant Manager, Engine and Propeller Directorate, Aircraft Certification Service. [FR Doc. E8-3463 Filed 2-22-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-107592-00] RIN 1545-BA11 Consolidated Returns; Intercompany Obligations AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Partial withdrawal of notice of proposed rulemaking. SUMMARY: This document withdraws a portion of a notice of proposed rulemaking (REG-107592-00) published in the **Federal Register** on September 28, 2007 (72 FR 55139). The withdrawn portion relates to the treatment of transactions involving the provision of insurance between members of a consolidated group. FOR FURTHER INFORMATION CONTACT: Frances L. Kelly,
(202)622-7770 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background On September 28, 2007, the IRS and the Treasury Department published a notice of proposed rulemaking (REG-107592-00) in the **Federal Register** (72 FR 55139) which proposed to amend § 1.1502-13(g) (regarding the treatment of transactions involving obligations between members of a consolidated group) and to add § 1.1502-13(e)(2)(ii)(C) (regarding the treatment of certain transactions involving the provision of insurance between members of a consolidated group). Under proposed § 1.1502-13(e)(2)(ii)(C), certain intercompany insurance transactions would be taken into account on a single entity basis. Written comments were received with respect to proposed § 1.1502-13(e)(2)(ii)(C). After consideration of these comments, the IRS and the Treasury Department have decided to withdraw proposed § 1.1502-13(e)(2)(ii)(C). However, the IRS and the Treasury Department continue to study whether revisions to the rules for intercompany transactions are necessary to clearly reflect the taxable income of consolidated groups. List of Subjects in 26 CFR Part 1 Income taxes, Reporting and recordkeeping requirements. Partial Withdrawal of a Notice of Proposed Rulemaking Accordingly, under the authority of 26 U.S.C. 7805 and 26 U.S.C. 1502, § 1.1502-13(e)(2)(ii)(C) of the notice of proposed rulemaking (REG-107592-00) that was published in the **Federal Register** on September 28, 2007 (72 FR 55139) is withdrawn. Linda E. Stiff, Deputy Commissioner for Services and Enforcement. [FR Doc. 08-823 Filed 2-20-08; 8:48 am]
Connectionstraces to 41
Traces to 41 documents
U.S. Code
33 references not yet in our index
  • 14 CFR 97
  • 1 CFR 51
  • 21 CFR 101
  • Pub. L. 101-535
  • 5 USC 601-612
  • Pub. L. 104-4
  • 44 USC 3501-3520
  • 5 CFR 1320.3(c)(2)
  • 518 U.S. 470
  • 505 U.S. 504
  • 28 CFR 16
  • 18 USC 4203(a)(1)
  • 32 CFR 240
  • 33 CFR 401
  • 49 USC 4321
  • 109 Stat. 48
  • 49 CFR 1.52
  • 47 CFR 73
  • 49 CFR 578
  • Pub. L. 101-410
  • Pub. L. 104-134
  • 49 CFR 578.6(f)(1)
  • 49 CFR 578.6(h)(1)
  • Pub. L. 106-414
  • Pub. L. 109-59
  • 49 CFR 1.50
  • 50 CFR 648
  • 50 CFR 660
  • 7 CFR 930
  • 7 USC 601-674
  • 7 CFR 900.400
  • 14 CFR 39
  • 26 CFR 1
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Final rule
U.S.C.§ 552
C.F.R.§ 97.20
Fed. Reg.Notices
U.S.C.§ 106
C.F.R.§ 101.14
C.F.R.§ 101.70
C.F.R.§ 101.77
C.F.R.§ 101.81
U.S.C.§ 343
SCOTUS518 U.S. 470
SCOTUS505 U.S. 504
Cite14 CFR 97
Cites 74 · showing 12Cited by 0 across 0 sources
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