Unknown. Final rule

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--- schema: federal-register doc_type: fedreg source_file: FR-2008-01-18.xml --- 73 13 Friday, January 18, 2008 Contents Agricultural Agricultural Marketing Service RULES Domestic Dates Produced or Packed in Riverside County, California; Decreased Assessment Rate, 3377-3379 E8-878 Agriculture Agriculture Department See Agricultural Marketing Service See Animal and Plant Health Inspection Service See Federal Crop Insurance Corporation See Forest Service NOTICES Meetings: Federal Advisory Committee for the Expert Review of Synthesis and Assessment Product 4.3, 3448 08-189 Animal Animal and Plant Health Inspection Service RULES Bovine Spongiform Encephalopathy;

Minimal-Risk Regions: Identification of Ruminants, and Processing and Importation of Commodities, 3379-3385 E8-883 Arctic Arctic Research Commission NOTICES Meetings, 3450 08-155 Arts Arts and Humanities, National Foundation See National Foundation on the Arts and the Humanities Blind Blind or Severely Disabled, Committee for Purchase From People Who Are See Committee for Purchase From People Who Are Blind or Severely Disabled Centers Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 3468-3469 E8-842 Centers Centers for Medicare & Medicaid Services RULES Revisit User Fee Program for Medicare Survey and Certification Activities, 3405-3409 E8-895 PROPOSED RULES Medicaid Program: Self-Directed Personnel Assistance Services Program State Plan Option (Cash and Counseling), 3546-3566 08-115 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 3469-3470 E8-909 E8-911 Commerce Commerce Department See Economic Development Administration See International Trade Administration See National Oceanic and Atmospheric Administration Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List Proposed Addition and Deletions, 3450-3451 E8-885 Commodity Commodity Futures Trading Commission NOTICES Meetings;

Sunshine Act, 3455 08-190 08-195 08-196 Defense Defense Department RULES Foreign Acquisition; CFR Correction, 3409 08-55501 Drug Drug Enforcement Administration PROPOSED RULES Registration Requirements for Importer and Manufacturers: Prescription Drug Products Containing Ephedrine, Pseudoephedrine, or Phenylpropanolamine, 3432-3441 E8-774 Economic Economic Development Administration NOTICES Petitions by Firms for Determination of Eligibility to Apply for Trade Adjustment Assistance, 3451-3452 E8-869 Education Education Department NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 3455-3456 E8-890 E8-891 Employment Employment and Training Administration NOTICES Amended Certification Regarding Eligibility to Apply for Worker Adjustment Assistance etc.: Avery Dennison Corp. et al., 3487 E8-841 Bodine Corp. et al., 3487-3488 E8-840 Delphi Corp. et al., 3488 E8-838 Negative Determination Regarding Application for Reconsideration: Nortel Networks Corp. et al., 3488-3489 E8-839 Termination of Investigation: Hubbard Supply Company Leased On-Site Workers etc., 3489 E8-837 Energy Energy Department See Federal Energy Regulatory Commission EPA Environmental Protection Agency RULES Air pollution; standards of performance for new stationary sources; and air pollutants, hazardous; national emission standards:

Stationary spark ignition internal combustion engines and reciprocating internal combustion engines, 3568-3614 E7-25394 Approval and Promulgation of Air Quality Implementation Plans; Designation of Areas for Air Quality Planning Purposes: Arizona; San Manuel Sulfur Dioxide State Implementation Plan and Request for Redesignation to Attainment, 3396-3405 E8-803 Nevada; Washoe County 8-Hour Ozone Maintenance Plan, 3389-3396 E8-743 PROPOSED RULES Approval and Promulgation of Air Quality Implementation Plans;

Designation of Areas for Air Quality Planning Purposes: Arizona; San Manuel Sulfur Dioxide State Implementation Plan and Request for Redesignation to Attainment, 3447 E8-804 Nevada; Washoe County 8-Hour Ozone Maintenance Plan, 3446-3447 E8-746 NOTICES Draft Toxicological Review of 1,2,3-Trichloropropane: In Support of the Summary Information in the Integrated Risk Information System (IRIS), 3462-3463 E8-887 Environmental Impact Statements; Notice of Availability, 3464 E8-881 Environmental Impact Statements and Regulations;

Availaility of EPA Comments, 3463 E8-877 Official Release of EMFAC2007 Motor Vehicle Emission Factor Model for Use in the State of California, 3464-3467 E8-876 Equal Equal Employment Opportunity Commission RULES Procedural Regulations Under Title VII and ADA, 3387-3389 E8-826 NOTICES Meetings: Sunshine Act; Cancelled, 3467 08-187 Executive Executive Office of the President See Trade Representative, Office of United States FAA Federal Aviation Administration RULES Special Conditions:

Embraer S.A., Model EMB-500; Fire Extinguishing for Aft Fuselage Mounted Engines, 3385-3387 E8-849 PROPOSED RULES Airworthiness Directives: British Aerospace Regional Aircraft Model HP.137 Jetstream Mk.1 et al., 3428-3430 E8-824 General Electric Company CF34 1A, 3A, 3A1, 3A2, 3B, and 3B1 Turbofan Engines, 3425-3428 E8-821 McDonnell Douglas Model 717 200 Airplanes et al., 3422-3425 E8-857 McDonnell Douglas Model DC 8 31, DC 8 32, DC 8 33, DC 8 41, DC 8 42, and DC 8 43 Airplanes et al., 3419-3422 E8-854 Pacific Aerospace Limited Model 750XL Airplanes, 3417-3419 E8-827 Proposed Establishment of Class E Airspace:

Pagosa Springs, CO, 3430-3431 E8-850 Proposed Establishment of Class E Airspace; Walden, CO, 3431-3432 E8-844 NOTICES Environmental Statements; Availability, etc.: Abraham Lincoln Capital Airport, Springfield, IL, 3508 08-166 Intent to Rule on Request to Release Airport Property at Pearland Regional Airport, TX, 08-167 3508-3509 08-168 Meetings: RTCA, Inc., 3509 08-165 National Parks Overflight Advisory Group Aviation Rulemaking Committee; Membership Availability, 3510 08-163 Order Limiting Scheduled Operations at John F.

Kennedy International Airport, 3510-3542 08-171 Federal Crop Federal Crop Insurance Corporation PROPOSED RULES Common Crop Insurance Regulations: Dry Pea Crop Provisions, 3411-3417 E8-321 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 3467-3468 08-226 Federal Energy Federal Energy Regulatory Commission NOTICES Availability of the Environmental Assessment of the Proposed Colorado Lateral Expansion Project, 3457 E8-864 Filing of Projects Retirement Study Report and Soliciting Comments, Motions to Intervene, and Protests:

Consumers Energy Company, 3457-3458 E8-863 Final Environmental Impact Statement; Proposed Broadwater LNG Project: Broadwater Energy LLC, et al., 3458-3459 E8-868 Intent to Prepare an Environmental Assessment: Proposed Dominion Hub I Project; Request for Comments on Environmental Issues, 3459-3461 E8-865 Notice of Filing, 3461 E8-867 Notice of Request Under Blanket Authorization: Trunkline Gas Company, LLC, 3461-3462 E8-866 Fish Fish and Wildlife Service NOTICES Application for Incidental Take Permit;

Construction of Single-family Home, Charlotte County, FL, 3478-3479 E8-825 Food Food and Drug Administration RULES Human Cells, Tissues, and Cellular and Tissue-Based Products CFR Correction, 3387 08-55500 NOTICES Draft Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment; Availability, 3470-3471 E8-835 Forest Forest Service NOTICES Meetings: Colorado Recreation Resource Advisory Committee, 3448-3449 08-154 White River National Forest; Summit County, CO;

Breckenridge Ski Resort—Peak 6 Terrain Development Proposal, 3449-3450 E8-631 GSA General Services Administration RULES Foreign Acquisition; CFR Correction, 3409 08-55501 Health Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Food and Drug Administration See Health Resources and Services Administration See National Institutes of Health Health Health Resources and Services Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 3471 E8-879 Housing Housing and Urban Development Department NOTICES Federal Property Suitable as Facilities to Assist the Homeless, 3473-3478 E8-665 Inter-American Inter-American Foundation NOTICES Meetings; Sunshine Act, 3478 08-197 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See Minerals Management Service IRS Internal Revenue Service PROPOSED RULES Guidance on Qualified Tuition Programs Under Section 529, 3441-3446 E8-859 International International Trade Administration NOTICES Certain Cut-to-Length Carbon Steel Plate from Romania:

Amended Final Results of Antidumping Duty Administrative Review Pursuant to Final Court Decision, 3452 E8-898 Certain Tissue Paper Products from China: Extension of Preliminary Results of Antidumping Duty Administrative Review, 3452-3453 E8-896 Stainless Steel Plate in Coils from Belgium: Extension of Time Limit for Preliminary Results of Administrative Review, 3453 E8-899 International International Trade Commission NOTICES Decision Not to Review Initial Determinations Granting Motions to Terminate Investigations as to All Respondents, etc., 3483-3484 E8-822 Glycine From Japan and Korea, 3484 E8-862 Justice Justice Department See Drug Enforcement Administration See Justice Programs Office NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 3484-3486 E8-847 E8-848 Justice Justice Programs Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 3486 E8-851 Meetings: Global Justice Information Sharing Initiative Federal Advisory Committee, 3487 E8-897 Labor Labor Department See Employment and Training Administration See Occupational Safety and Health Administration Land Land Management Bureau NOTICES Competitive Coal Lease Sale, Wyoming, 3479-3480 E8-882 Indian Gaming, 3480 E8-894 Realty Action:

(Non-Competitive) Direct Sale of Public Land; Granite County, MT, 3480-3481 08-149 Recreation and Public Purposes (R&PP) Act Classification, 3481-3482 E8-874 Legal Legal Services Corporation NOTICES Meetings; Sunshine Act, 3490-3492 08-215 Minerals Minerals Management Service NOTICES Draft Environmental Impact Statement and Public Hearings; Cape Wind Energy Project, 3482-3483 E8-845 NASA National Aeronautics and Space Administration RULES Foreign Acquisition; CFR Correction, 3409 08-55501 National Archives National Archives and Records Administration NOTICES Records Schedules;

Availability and Request for Comments, 3492-3493 E8-855 National Foundation National Foundation on the Arts and the Humanities NOTICES Meetings: Humanities Panel, 3493-3494 E8-834 NIH National Institutes of Health NOTICES Meetings: National Human Genome Research Institute, 3471-3472 08-160 National Institute of Allergy and Infectious Diseases, 3472 08-156 National Institute of Child Health and Human Development, 3472-3473 08-159 National Institute of Dental and Craniofacial Research, 3472 08-157 National Library of Medicine, 3473 08-158 NOAA National Oceanic and Atmospheric Administration NOTICES Availability of Draft Environmental Assessment Considering the States of Oregon, Idaho, and Washington's Request for Lethal Removal Authority, 3453-3455 E8-893 Nuclear Nuclear Regulatory Commission NOTICES Meetings:

Geologic Repository Operations Area Security and Material Control and Accounting Requirements; cancellation, 3494-3495 E8-873 Receipt of Application for Design Certification of the US-APWR; Mitsubishi Heavy Industries, LTD, 3495 E8-872 Occupational Occupational Safety and Health Administration NOTICES Federal Advisory Council on Occupational Safety and Health, 3489-3490 E8-886 Office of U.S. Trade Office of United States Trade Representative See Trade Representative, Office of United States Personnel Personnel Management Office PROPOSED RULES Personnel Records, 3410-3411 E8-858 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, [ **Editorial Note: ** This document, appearing at 73 FR 3292 in the **Federal Register** of Thursday, January 17, 2007, was inadvertently placed under the Management and Budget Office in that day's Table of Contents.] SEC Securities and Exchange Commission NOTICES Self-Regulatory Organizations; Proposed Rule Changes: Chicago Board Options Exchange, Inc., 3496-3497 E8-861 Chicago Stock Exchange, Inc., 3497-3500 E8-831 E8-860 Financial Industry Regulatory Authority, Inc., 3500-3502 E8-829 National Futures Association, 3502-3503 E8-833 New York Stock Exchange LLC, 3503-3504 E8-832 Sentencing Sentencing Commission, United States See United States Sentencing Commission Social Social Security Administration NOTICES Social Security Ruling

(SSR)94-4p, etc., 3505 E8-880 State State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 3505-3507 E8-901 E8-904 List of November 8, 2007 Participating Countries and Entities Under the Clean Diamond Trade Act of 2003, etc., 3507-3508 E8-900 Surface Surface Transportation Board NOTICES Release of Waybill Data, 3543 E8-892 Thrift Thrift Supervision Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 3543-3544 E8-906 E8-907 Trade Trade Representative, Office of United States NOTICES Generalized System of Preferences (GSP): Initiation of Child Labor Review in the Production of Certain GSP-Eligible Hand-loomed or Hand-hooked Carpets, 3495-3496 E8-905 Transportation Transportation Department See Federal Aviation Administration See Surface Transportation Board Treasury Treasury Department See Internal Revenue Service See Thrift Supervision Office NOTICES Meetings: Debt Management Advisory Committee, 3543 08-162 U.S. Sentencing United States Sentencing Commission NOTICES Sentencing Guidelines for United States Courts, 3504-3505 E8-889 Separate Parts In This Issue Part II Health and Human Services Department, Centers for Medicare & Medicaid Services, 3546-3566 08-115 Part III Environmental Protection Agency, 3568-3614 E7-25394 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 13 Friday, January 18, 2008 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 987 [Docket No. AMS-FV-07-0104; FV07-987-1 FIR] Domestic Dates Produced or Packed in Riverside County, CA; Decreased Assessment Rate AGENCY: Agricultural Marketing Service, USDA. ACTION: Final rule. SUMMARY: The Department of Agriculture

(USDA)is adopting, as a final rule, without change, an interim final rule which decreased the assessment rate established for the California Date Administrative Committee (committee) for the 2007-08 and subsequent crop years from $0.95 to $0.75 per hundredweight of dates handled. The committee locally administers the marketing order which regulates the handling of dates grown or packed in Riverside County, California. Assessments upon date handlers are used by the committee to fund reasonable and necessary expenses of the program. The crop year began October 1 and ends September 30. The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated. DATES: *Effective Date:* February 19, 2008. FOR FURTHER INFORMATION CONTACT: Terry Vawter, Senior Marketing Specialist, or Kurt J. Kimmel, Regional Manager, California Marketing Field Office, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA; Telephone:

(559)487-5901, Fax:

(559)487-5906, or E-mail: *Terry.Vawter@usda.gov* or *Kurt.Kimmel@usda.gov* . Small businesses may request information on complying with this regulation by contacting Jay Guerber, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC 20250-0237; Telephone:

(202)720-2491, Fax:

(202)720-8938, or E-mail: *Jay.Guerber@usda.gov* . SUPPLEMENTARY INFORMATION: This rule is issued under Marketing Order No. 987, as amended (7 CFR part 987), regulating the handling of dates grown or packed in Riverside County, California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” USDA is issuing this rule in conformance with Executive Order 12866. This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, California date handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as issued herein will be applicable to all assessable dates beginning October 1, 2007, and continue until amended, suspended, or terminated. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule. The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling. This rule continues in effect the action that decreased the assessment rate established for the committee for the 2007-08 and subsequent crop years from $0.95 per to $0.75 per hundredweight of dates. The California date marketing order provides authority for the committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the committee are producers and handlers of California dates. They are familiar with the committee's needs and with the costs for goods and services in their local area, and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input. For the 2005-06 and subsequent crop years, the committee recommended, and USDA approved, an assessment rate that would continue in effect from crop year to crop year unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the committee or other information available to USDA. The committee met on June 21, 2007, and unanimously recommended 2007-08 expenditures of $209,182 and an assessment rate of $0.75 per hundredweight of California dates. In comparison, last year's budgeted expenditures were $127,485. The assessment rate of $0.75 is $0.20 lower than the rate currently in effect. The committee believes that the assessment rate should be reduced, because the 2006-07 crop was 3 million pounds larger than expected, resulting in $105,652 in accumulated cash reserves available for 2007-08 expenditures. Section 987.72(c) states that the reserve may not exceed 50 percent of the average of expenses incurred during the most recent five preceding crop years. The committee believes the decreased assessment rate will allow it to reduce the amount it holds in cash reserves to $30,115, by September 30, 2008, the end of the 2007-08 crop year. That reserve amount would be within the limits provided in § 987.72(c). Proceeds from sales of cull dates are deposited in a surplus account for subsequent use by the committee in covering the surplus pool share of the committee's expenses. Handlers may also dispose of cull dates of their own production within their own livestock-feeding operation; otherwise, such cull dates must be shipped or delivered to the committee for sale to non-human food product outlets. Pursuant to § 987.72(b), the committee is authorized to temporarily use funds derived from assessments to defray expenses incurred in disposing of surplus dates. All such expenses are required to be deducted from proceeds obtained by the committee from the disposal of surplus dates. For the 2007-08 crop year, the committee estimated that $2,000 from the surplus account would be needed temporarily to defray committee expenses incurred in disposing of surplus dates. The major expenditures recommended by the committee for the 2007-08 crop year include $87,312 for general and administrative programs, $67,870 for promotional programs, $24,000 for marketing and media consulting, $5,000 for moving expenses, and $5,000 for updating marketing materials. The committee also budgeted $20,000 as a contingency reserve for other marketing and promotion projects that it may wish to support later in the year. By comparison, expenditures for the 2006-07 crop year were $127,485. Major expenditures recommended by the committee included $75,095 for general and administrative expenses, $22,390 for promotional expenses, and $30,000 for date nutritional analysis. The assessment rate of $0.75 per hundredweight of assessable dates was derived by applying the following formula where: A= 2006-07 reserve on 10/1/07 ($105,652); B= 2007-08 reserve on 9/30/07 ($30,115); C= 2007-08 expenses ($209,182); D= Cull Surplus Fund ($2,000); E= Assessment Refund ($10,855); and F= 2007-08 expected shipments (190,000 hundredweight). (B−A+C−D+E)/F. The assessment rate established in this rule will continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the committee or other available information. Although this assessment rate is effective for an indefinite period, the committee will continue to meet prior to or during each crop year to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of committee meetings are available from the committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The committee's 2007-08 budget and those for subsequent crop years will be reviewed and, as appropriate, approved by USDA. Final Regulatory Flexibility Analysis Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service

(AMS)has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis. The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. There are approximately 124 producers of dates in the production area and approximately 10 handlers subject to regulation under the marketing order. The Small Business Administration

(SBA)(13 CFR 121.201) defines small agricultural producers as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those having annual receipts of less than $6,500,000. An industry profile shows that four of the 10 handlers (40 percent) had date sales over $6,500,000 and could be considered large handlers by the SBA. Six of the 10 handlers (60 percent) had date sales of less than $6,500,000 and could be considered small handlers. An estimated 7 producers, or less than 6 percent, of the 124 total producers, would be considered large producers with annual incomes over $750,000. The remaining producers have incomes less than $750,000. The majority of handlers and producers of California dates may be classified as small entities. This rule continues in effect the action that decreased the assessment rate established for the committee and collected from handlers for the 2007-08 and subsequent crop years from $0.95 to $0.75 per hundredweight of dates handled. The committee unanimously recommended 2007-08 expenditures of $209,182 and an assessment rate of $0.75 per hundredweight of dates, which is $0.20 lower than the 2005-06 rate, currently in effect. The committee recommended decreasing the assessment rate to reduce its cash reserve levels. The quantity of assessable dates for the 2007-08 crop year is estimated at 19,000,000 pounds. Thus, the $0.75 rate should provide $142,500 in assessment income and, with reserve funds of $105,652 and the $2,000 contribution from the surplus program, will be adequate to meet the 2007-08 crop year expenses. The major expenditures recommended by the committee for the 2007-08 crop year include $87,312 for general and administrative programs, $67,870 for promotional programs, $24,000 for marketing and media consulting, $5,000 for moving expenses, and $5,000 for updating marketing materials. The committee also budgeted $20,000 as a contingency reserve for other marketing and promotion projects that it may wish to support later in the year. The committee recommended a reduced assessment rate because the unanticipated increased date production during the 2006-07 crop year resulted in a larger carry-in of funds than the committee prefers. The decrease in the assessment rate would allow the committee to reduce its cash reserves to an appropriate level. The committee reviewed and unanimously recommended 2007-08 crop year expenditures of $209,182. Prior to arriving at this budget, the committee considered information from various sources, such as the committee's Marketing Subcommittee. Alternative expenditure levels were an option available to the committee, but given the windfall from the larger-than-expected 2006-07 crop, it was ultimately determined that a $209,182 budget would be most beneficial to the industry. The assessment rate of $0.75 per hundredweight of dates was then derived, based upon the committee's estimates of the available reserve, income, handler assessment refund, and anticipated expenses. A review of historical information and preliminary information pertaining to the 2007-08 crop year indicates that the grower price for the 2007-08 crop year could range between $45 and $50 per hundredweight of dates. Therefore, the estimated assessment revenue for the 2007-08 crop year as a percentage of total grower revenue is approximately 1.67 to 1.5 percent, respectively. This action continues in effect the action that decreased the assessment obligation imposed on handlers. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to producers. However, decreasing the assessment rate reduces the burden on handlers, and may reduce the burden on producers. In addition, the committee's meeting was widely publicized throughout the California date industry and all interested persons were invited to attend the meeting and participate in committee deliberations on all issues. Like all committee meetings, the June 21, 2007 meeting was a public meeting and all entities, both large and small, were able to express views on this issue. This action imposes no additional reporting or recordkeeping requirements on either small or large California date handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. In addition, as noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule. AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule. An interim final rule concerning this action was published in the **Federal Register** on September 7, 2007 (72 FR 51354). Copies of that rule were also mailed or sent via facsimile to all date handlers. Finally, the interim final rule was made available through the Internet by USDA and the Office of the Federal Register. A 60-day comment period was provided for interested persons to respond to the interim final rule. The comment period ended on November 6, 2007, and no comments were received. A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: *http://www.ams.usda.gov/fv/moab.html.* Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section. After consideration of all relevant material presented, including the information and recommendation submitted by the committee and other available information, it is hereby found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act. List of Subjects in 7 CFR Part 987 Dates, Marketing agreements, Reporting and recordkeeping requirements. PART 987—DATES PRODUCED OR PACKED IN RIVERSIDE COUNTY, CALIFORNIA Accordingly, the interim final rule amending 7 CFR part 987 which was published at 72 FR 51354 on September 7, 2007, is adopted as a final rule without change. Dated: January 15, 2008. Lloyd C. Day, Administrator, Agricultural Marketing Service. [FR Doc. E8-878 Filed 1-17-08; 8:45 am] BILLING CODE 3410-02-P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Parts 93, 94, and 95 [Docket No. APHIS-2006-0026] RIN 0579-AC45 Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Identification of Ruminants, and Processing and Importation of Commodities AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Final rule. SUMMARY: We are amending the regulations regarding the importation of animals and animal products to remove several restrictions regarding the identification of animals and the processing of ruminant materials from regions that present a minimal risk of introducing bovine spongiform encephalopathy into the United States. We are removing these restrictions because they are not necessary to prevent the introduction of bovine spongiform encephalopathy into the United States. DATES: *Effective Date:* February 19, 2008. FOR FURTHER INFORMATION CONTACT: For information regarding ruminant products, contact Dr. Karen James-Preston, Director, Technical Trade Services, Animal Products, National Center for Import and Export, VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737-1231;

(301)734-4356. For information concerning live ruminants, contact Dr. Freeda Isaac, Director, AOVSA, National Center for Import and Export, VS, APHIS, 4700 River Road, Unit 39, Riverdale, MD 20737-1231;

(301)734-8364. SUPPLEMENTARY INFORMATION: Background The Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture regulates the importation of animals and animal products into the United States to guard against the introduction of animal diseases not currently present or prevalent in this country. The regulations in 9 CFR parts 93, 94, and 95 prohibit or restrict the importation into the United States of specified animals and animal products to prevent the introduction into the United States of various animal diseases, including bovine spongiform encephalopathy (BSE). In a final rule published in the **Federal Register** on January 4, 2005 (70 FR 460-553, Docket No. 03-080-3), we amended the regulations regarding the importation of animals and animal products to establish a category of regions that present a minimal risk of introducing BSE into the United States via live ruminants and ruminant products and byproducts, and added Canada to this category. We also established conditions for the importation of certain live ruminants and ruminant products and byproducts from such regions. These regulations are in 9 CFR parts 93, 94, 95, and 96. On November 28, 2005, we published in the **Federal Register** an interim rule (70 FR 71213-71218, Docket No. 03-080-8) that

(1)broadened who is authorized to break the seals on a means of conveyance carrying certain ruminants from Canada and

(2)amended the provisions regarding the transiting through the United States of certain ruminant products from Canada to allow for limited direct transloading of the products from one means of conveyance to another in the United States. On March 14, 2006, we published in the **Federal Register** a technical amendment (71 FR 12994-12998, Docket No. 03-080-9) that clarified our intent with regard to certain provisions in the January 2005 final rule and corrected several inconsistencies within the rule. On August 9, 2006, we published in the **Federal Register** a proposed rule 1 (71 FR 45439-45444, Docket No. APHIS-2006-0026) to amend the regulations in 9 CFR parts 93, 94, and 95 to remove several restrictions regarding the identification of ruminants and the processing of ruminant materials from BSE minimal-risk regions, as well as BSE-based restrictions on gelatin derived from bovine hides. 1 To view the proposed rule and the comments we received, go to *http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2006-0026* . We solicited comments concerning our August 2006 proposed rule (referred to below as the “proposed rule”) for 60 days ending October 10, 2006. In a document published in the **Federal Register** on November 9, 2006 (71 FR 65758-65759, Docket No. APHIS-2006-0026), we reopened and extended the deadline for comments until November 24, 2006. We received 10 comments in response to our proposed rule. They were from organizations representing U.S. producers of livestock and livestock products, renderers, and other members of the public. The comments dealt with live animals as well as animal products. We discuss the comments below by topic. Changes to This Final Rule Based on a September 2007 Final Rule On September 18, 2007, we published in the **Federal Register** a final rule (72 FR 53113-53379, Docket No. APHIS-2006-0041; effective November 19, 2007) that established conditions for the importation into the United States from BSE minimal-risk regions of certain bovines and bovine commodities that had not been made eligible for importation by our January 2005 final rule. Some of the changes we made to the regulations in our September 2007 final rule affected regulatory text we had proposed to change in our August 2006 proposed rule, either by rewording text, deleting provisions that would have been changed by our August 2006 proposed rule, or redesignating CFR paragraph references. Consequently, we have made changes to this final rule to reflect the changes made by our September 2007 final rule. In our discussion of this final rule, we identify where those changes occur. Comments Received in Response to Our August 2006 Proposed Rule Identification of Live Ruminants Exported to the United States From BSE Minimal-Risk Regions One of the changes to the regulations we proposed in our August 2006 proposed rule was a broadening of the options of acceptable forms of individual identification of bovines, sheep, and goats exported to the United States from BSE minimal-risk regions (currently only Canada). Under the current regulations in § 93.436, live bovines imported from a BSE minimal-risk region must be individually identified by means of an official eartag of the country of origin. The eartag must be determined by the APHIS Administrator to meet standards equivalent to those for official eartags in the United States, as defined in 9 CFR part 71, and to be traceable to the premises of origin. There is a similar requirement for sheep and goats in § 93.419. However, because § 93.419 refers specifically to sheep and goats from Canada, that section requires that sheep and goats from Canada be individually identified by an official Canadian Food Inspection Agency eartag. In our proposed rule, we proposed to allow for means of individual identification other than eartags for the imported bovines, sheep, and goats. We proposed to provide that the animals must be officially identified with individual identification before the animals' arrival at the port of entry into the United States. We proposed to define *officially identified* to mean “individually identified by means of an official identification device or method.” In § 93.400 of the current regulations, *official identification device or method* is defined as a means of officially identifying an animal or group of animals using devices or methods approved by the Administrator, including, but not limited to, official tags, tattoos, and registered brands when accompanied by a certificate of inspection from a recognized brand inspection authority. We proposed to add a sentence at the end of that definition to make it clear that, for animals intended for importation into the United States, the particular device or method of identification must have been approved by the Administrator for that type of import before the animal is exported to the United States. Several commenters expressed concern that our proposed change regarding animal identification would hinder the ability to conduct rapid traceback of cattle to their herd of origin in the event BSE is diagnosed in an animal imported from a BSE minimal-risk region. One of the commenters recommended that the identification requirements in the current regulations be retained. Another commenter recommended that the regulations explicitly require that all cattle from a BSE minimal-risk region be individually identified with a device or method that is visible and readable and that includes a unique animal identification number that enables traceback to the herd of origin. We agree with the commenters that the individual identification of cattle—and sheep and goats—imported from a BSE minimal-risk region must be unique to individual animals and allow for rapid traceback of an animal to its herd of origin. The intent of the change we proposed was not to remove that requirement from the regulations, but simply to allow, in addition to eartags, other forms of individual identification that meet those criteria. That is the reason we proposed to provide in the definition of *official identification device or method* that the identification used must have been approved by the Administrator for that type of import before the animal is exported to the United States. To ensure that there is no misunderstanding of our intent, in this final rule we are specifying in § 93.436(a)(2) and (b)(3) that, before arrival at the port of entry into the United States, each bovine imported into the United States from a BSE minimal-risk region must be officially identified with unique individual identification that is traceable to the premises of origin of the animal. 2 In § 93.419(c), we are including a similar identification requirement for sheep and goats imported from Canada. 2 **Note:** Paragraphs (a)(2) and (b)(3) of § 93.436 were designated as paragraphs (a)(3) and (b)(4), respectively, in our proposed rule, but are redesignated in this final rule to reflect the changes made in our September 2007 final rule. In our August 2006 proposed rule, we proposed to replace the word “eartag” with the term “official identification” in what, at that time, were paragraphs (b)(8) and (b)(11) of § 93.436. However, our September 2007 final rule removed § 93.436(b)(8) and (b)(11). In addition to addressing the issue of the types of allowable individual identification, two commenters expressed support for identification provisions of the current regulations that we did not propose to change. These are:

(1)The provision that no person may alter, deface, remove, or otherwise tamper with the official identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at slaughter; and

(2)the requirement that cattle imported from a BSE minimal-risk region for other than immediate slaughter be identified, before export to the United States, with a permanent mark that indicates the country of origin. Gelatin In § 94.19(f)(2) of our proposed rule, we proposed to allow the importation into the United States of gelatin derived from the hides of bovines from BSE minimal-risk regions, provided the gelatin has not been commingled with materials ineligible for entry into the United States. In accordance with the regulations as amended by our September 2007 final rule, gelatin imported into the United States from a BSE minimal-risk region must either

(1)be derived from the bones of bovines subject to a ruminant feed ban equivalent to the requirements established by the U.S. Food and Drug Administration at 21 CFR 589.2000 and from which specified risk materials were removed (§ 94.19(f)), or

(2)be imported for use in human food, human pharmaceutical products, photography, or some other use that will not result in the gelatin coming into contact with ruminants in the United States (§ 94.18(c)). A number of commenters supported allowing the importation of gelatin derived from the hides of bovines from BSE minimal-risk regions. One commenter stated that it does not make sense to allow the importation of gelatin derived from hides of bovines from BSE minimal-risk regions at the same time the regulations restrict the importation of gelatin derived from bones. We disagree that it does not make sense to allow the importation of gelatin derived from hides. Bovine hides have not demonstrated BSE infectivity, even in infected animals, and the safety of bovine hides with regard to BSE is recognized internationally. The World Organization of Animal Health (commonly referred to as the OIE) supported that conclusion in its recommendation that gelatin derived exclusively from the hides of bovines not be subject to import restrictions (OIE Terrestrial Animal Health Code (the Code), 2006, Article 2.3.13.1). The European Commission Scientific Steering Committee reached a similar conclusion regarding the lack of BSE infectivity in hide-derived gelatin, provided contamination with potentially infected materials is avoided (European Commission's Updated Opinion on the Safety with Regard to TSE Risk of Gelatine Derived from Ruminant Bones or Hides, December 2002). In contrast, gelatin derived from the bones of bovines from BSE minimal-risk regions can pose a risk of infectivity unless the risk mitigation measures in §§ 94.18(c) and 94.19(f), described above, are taken. The higher BSE risk of bone-derived gelatin is recognized internationally. The OIE Code contains BSE risk mitigation guidelines for gelatin derived from bovines (Article 2.3.13.15). The European Commission Scientific Steering Committee concluded in its Updated Opinion that “the risk of transmissible spongiform infectivity is much higher with bones, as compared to hides.” Therefore, we are making no changes based on this comment. Processing of Non-Ruminant Material in BSE Minimal-Risk Regions The current regulations in § 95.4(c) allow the importation of certain materials derived from nonruminants from BSE minimal-risk regions only if all steps of processing and storing the material are carried out in a facility that has not been used for the processing and storage of materials derived from ruminants that have been in any region listed in § 94.18(a) of the regulations. The regions listed in § 94.18(a) include BSE minimal-risk regions, as well as regions in which BSE exists and regions that present an undue risk of introducing BSE into the United States. In our proposed rule, we proposed to amend § 95.4(c) so that nonruminant materials processed or stored in BSE minimal-risk regions would no longer need to be processed or stored in facilities separate from those used to process or store materials derived from ruminants from BSE minimal-risk regions. Several commenters supported the proposed change to § 95.4(c). One commenter stated that our intent regarding the proposed change to § 95.4(c) was not easily understandable from the wording we used in the regulatory text of the proposed rule. In § 95.4(c)(2) and

(3)of the proposed rule, we made reference to regions listed in § 94.18(a)(1), (a)(2), and (a)(3). Those paragraphs list the following types of regions: § 94.18(a)(1) lists regions in which BSE exists; § 94.18(a)(2) lists regions that, because of import requirements less restrictive than those that would be acceptable for import into the United States and/or because of inadequate surveillance, present an undue risk of introducing BSE into the United States; and § 94.18(a)(3) lists BSE minimal-risk regions (currently only Canada). The commenter stated that the regulations would be clearer if, when referring to § 94.18(a)(1), (a)(2), and (a)(3), we also indicated the BSE category of regions listed in those paragraphs. Because in § 95.4(c) as proposed we reference paragraphs that contain lists that can be easily described, we agree it would be useful to the reader if those references included a description of the content of each of those paragraphs. Therefore, we are including such descriptions in § 95.4(c)(2) and (c)(3) in this rule. Tallow One commenter addressed the provisions in § 95.4 regarding the importation of tallow. The commenter stated that APHIS should follow the OIE guideline of allowing the importation from BSE minimal-risk regions of tallow with no more than 0.15 percent impurities. We did not propose to make any changes to the regulations regarding the importation of tallow from BSE minimal-risk regions. However, the commenter is correct that the wording in § 95.4 regarding tallow differs from the OIE guidelines in one respect. One of the criteria in § 95.4 for the importation of tallow derived from bovines from BSE minimal-risk regions is that the tallow be composed of less than 0.15 percent insoluble impurities. This differs slightly from the OIE guidelines, which recommend allowing the importation of tallow with a maximum level of insoluble impurities of 0.15 percent in weight. The intent of our January 2005 final rule, as indicated on page 501 of the preamble to that rule, was to allow the importation of tallow composed of a maximum level of insoluble impurities of 0.15 percent in weight. However, the amendatory text of that rule incorrectly used the phrase “less than 0.15 percent.” Therefore, to make the wording of the regulations consistent with our stated intent, in this rule we are amending § 95.4 to require that bovine-derived tallow imported from a BSE minimal-risk region be composed of a maximum level of insoluble impurities of 0.15 percent in weight. Other Comments In our proposed rule, we proposed to specify in § 94.19(f)(1) (redesignated as § 94.19(g)(1) in our September 2007 final rule) as one of the conditions for the importation of gelatin derived from the bones of bovines from BSE minimal-risk regions that the gelatin not have been commingled with materials ineligible for entry into the United States. Other than that, we did not propose to change the provisions regarding gelatin derived from bones. One commenter, however, objected to the current regulations that allow the importation of bone-derived gelatin from BSE minimal-risk regions (currently only Canada). The commenter contended that the current regulations are erroneously based on the determination that Canada is a BSE minimal-risk region, and that Canada should instead be considered a country of undetermined BSE risk according to OIE recommendations. For similar reasons, a commenter opposed our proposal to no longer require that nonruminant materials processed or stored in BSE minimal-risk regions be processed or stored in facilities separate from those used to process or store materials derived from ruminants from BSE minimal-risk regions. The commenter expressed concern regarding what the commenter termed the “undetermined prevalence” of BSE in Canada and the detection of BSE in cows that were born after Canada implemented its feed ban. The commenter stated that APHIS should reconsider the proposed change on the basis that BSE infectivity is known to have circulated in Canada as recently as 2002. We are making no changes based on these comments. APHIS recognized Canada as a BSE minimal-risk region in our January 2005 final rule that was published following notice-and-comment rulemaking. We did not propose to revisit that determination in our August 2006 proposed rule and do not consider such a change to the BSE risk status of Canada to be scientifically supportable or appropriate. One of the conditions for being recognized by APHIS as a BSE minimal-risk region is that the region have in place and maintain risk mitigation measures adequate to prevent widespread exposure and/or establishment of the disease. In classifying Canada as a BSE minimal-risk region in our January 2005 final rule, we determined that such mitigation measures are in place and are maintained in Canada. We do not consider the diagnosis of BSE in several cows born after the establishment of the Canadian feed ban to be unexpected. Experience worldwide has demonstrated that, even in countries with an effective feed ban in place, BSE has occurred in cattle born after a feed ban was implemented. No regulatory effort can ensure 100 percent compliance. Isolated incidents, such as feed made from nonprohibited material being contaminated with prohibited material during processing, can occur due to human error. However, such isolated incidents are not epidemiologically significant and do not contribute to further spread of BSE, especially when considered in light of the entire risk pathway and its attendant risk mitigations. One commenter made the general request that APHIS delete from the regulations the provisions regarding imports from BSE minimal-risk regions until further research and surveillance is done regarding all transmissible spongiform encephalopathies. The commenter did not address any specific provision of our proposal, and we are making no changes based on the comment. One commenter requested that APHIS not require that products imported from a BSE minimal-risk region under the provisions of § 95.4 be accompanied by original signed certification, provided certain specified risk mitigation measures are in place. We consider the issue raised by the commenter to be outside the scope of the proposed rule, and are making no changes based on the comment. However, we will take the commenter's request into consideration in assessing the need for future rulemaking. Several commenters expressed general opposition to the importation of ruminants from Canada, but did not specifically address provisions of the proposed rule. We are making no changes based on those comments. Additional Nonsubstantive Changes In addition to those discussed above, we are making several other nonsubstantive changes in this final rule to be consistent with wording changes and paragraph redesignations made in our September 2007 final rule. Adoption of the Proposed Rule With Changes Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the changes discussed in this document. Executive Order 12866 and Regulatory Flexibility Act This rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget. The Regulatory Flexibility Act requires agencies to evaluate the potential effects of their proposed and final rules on small businesses, small organizations, and small governmental jurisdictions. We have prepared a final regulatory flexibility analysis, which is set forth below. In a final rule published in January 2005, we established a category of regions that present a minimal risk of introducing BSE into the United States via live ruminants and ruminant products and byproducts, and added Canada to that category. We also established conditions for the importation of certain live ruminants and ruminant products and byproducts from such regions. A final rule published in September 2007 included conditions for the importation of additional commodities from BSE minimal-risk regions. In this rule, we are removing certain restrictions on imports from BSE minimal-risk regions that concern animal identification, the derivation of bovine gelatin, and the processing of ruminant and nonruminant materials. We have determined these restrictions are not necessary to prevent the introduction of BSE into the United States. Instead of limiting the type of allowable individual identification on bovines, sheep, and goats imported from a BSE minimal-risk region to an official eartag of the country of origin, we are allowing unique individual identification of animals by means other than eartags, provided the APHIS Administrator has approved the manner of identification for the type of animal intended for importation and the identification is traceable to the premises of origin of the animal. Instead of limiting the importation of bovine-derived gelatin from BSE minimal-risk regions to gelatin derived from bones, we are allowing the importation of hide-derived gelatin, provided certain conditions are met. We are also allowing nonruminant material that is processed in BSE minimal-risk regions—such as processed animal protein, tankage, offal, certain tallow, processed fats and oils, and derivatives of processed animal protein, tankage, and offal—to be processed in facilities that also process material derived from ruminants from the minimal-risk region. We address below the potential economic effect of each of these changes. Animal Identification Giving owners of bovines, sheep, and goats in BSE minimal-risk regions the option of individually identifying animals being exported to the United States by means other than eartags is not expected to affect U.S. small entities. This amendment simply acknowledges that there are effective means of individual identification other than eartags, as long as the chosen device or method has been approved by the APHIS Administrator before the animal is exported to the United States. The unique individual identification must be traceable to the premises of origin of the animal (as is required of the eartags currently used), a disease control measure that will benefit all U.S. cattle producers, the majority of which are small entities. Hide-Derived Gelatin This amendment, by allowing the importation of gelatin derived from bovine hides in addition to gelatin derived from bovine bones, could affect U.S. entities by providing an additional source of gelatin imported from Canada. Gelatin is derived from collagen, an insoluble fibrous protein that is the principal constituent of connective tissues and bones. The main raw materials used in gelatin production are cattle bones, cattle hides, and porkskins. Gelatin recovered from bone is used primarily in photographic applications. Porkskin is currently the most significant raw material source for production of edible gelatin in North America. Cattle hides are the least used raw material for gelatin in North America today. Cattle hides sourced by member companies of the Gelatin Manufacturers Institute of America for the production of gelatin for food use are purchased from a small number of tanneries in the United States. We do not have information about the quantity of hide-derived gelatin that would be imported from Canada because of this rule, nor do we have an estimate of the number of U.S. small entities that would be affected. Production of animal hides is classified by the North American Industry Classification System (NAICS) under “Animal (except Poultry) Slaughtering” (NAICS 311611), for which the small entity definition is businesses with not more than 500 employees. In the initial regulatory flexibility analysis we conducted for our August 2006 proposed rule, we requested information that would allow us to better understand the number and size of entities that might be affected by allowing hide-derived bovine gelatin to be imported from BSE minimal-risk regions (currently only Canada), but we received no information of this type. Nonruminant Material This amendment removes the requirement that nonruminant material that is processed in BSE minimal-risk regions be processed in a facility that does not also process material derived from ruminants from the minimal-risk region. If this amendment results in changes in the amounts of nonruminant material imported by the United States, then U.S. entities could be affected. Affected nonruminant material may include processed animal protein, tankage, offal, certain tallow, processed fats and oils, and derivatives of processed animal protein, tankage, and offal. Facilities that produce these commodities are classified under “Rendering and Meat By-product Processing” (NAICS 311613), for which the small entity definition is businesses with not more than 500 employees. We do not have a basis for estimating the change in imports of Canadian nonruminant materials that might result from this rule, nor do we know the number or size of U.S. entities that will be affected. In our initial regulatory flexibility analysis, we requested information from the public regarding the number of small entities that might be affected and the likely magnitude of the effect, but we received no information of this type. We do not foresee any significant economic effects on small entities because of this rule. There are no significant alternatives to this rule that would accomplish the stated objectives. Without the rule, unnecessary restrictions on certain exports to the United States from BSE minimal-risk regions will continue. With the rule, animal exporters in BSE minimal-risk regions will have the option of individually identifying bovines, sheep, and goats being exported to the United States by means other than eartags; U.S. entities will be allowed to import hide-derived, in addition to bone-derived, gelatin from BSE minimal-risk regions; and ruminant and nonruminant materials that are processed in the same facility in a BSE minimal-risk region will be allowed to be exported to the United States. Executive Order 12988 This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule:

(1)Preempts all State and local laws and regulations that are inconsistent with this rule;

(2)has no retroactive effect; and

(3)does not require administrative proceedings before parties may file suit in court challenging this rule. Paperwork Reduction Act This rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). List of Subjects 9 CFR Part 93 Animal diseases, Imports, Livestock, Poultry and poultry products, Quarantine, Reporting and recordkeeping requirements. 9 CFR Part 94 Animal diseases, Imports, Livestock, Meat and meat products, Milk, Poultry and poultry products, Reporting and recordkeeping requirements. 9 CFR Part 95 Animal feeds, Hay, Imports, Livestock, Reporting and recordkeeping requirements, Straw, Transportation. Accordingly, we are amending 9 CFR parts 93, 94, and 95 as follows: PART 93—IMPORTATION OF CERTAIN ANIMALS, BIRDS, FISH, AND POULTRY, AND CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR MEANS OF CONVEYANCE AND SHIPPING CONTAINERS 1. The authority citation for part 93 continues to read as follows: Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4. 2. Section 93.400 is amended by revising the definition of *official identification device or method* and adding a definition of *officially identified,* in alphabetical order, to read as follows: § 93.400 Definitions. *Official identification device or method.* A means of officially identifying an animal or group of animals using devices or methods approved by the Administrator, including, but not limited to, official tags, tattoos, and registered brands when accompanied by a certificate of inspection from a recognized brand inspection authority. For animals intended for importation into the United States, the device or method of identification used must have been approved by the Administrator for that type of import before the animal is exported to the United States. *Officially identified.* Individually identified by means of an official identification device or method. § 93.405 [Amended] 3. In § 93.405, paragraph (a)(4) is amended by removing the word “eartag” and adding in its place the words “official identification”. 4. Section 93.419 is amended by revising paragraph

(c)and paragraphs (e)(2), (e)(5), (e)(7)(i), and (e)(7)(iii) to read as follows: § 93.419 Sheep and goats from Canada.

(c)Any sheep or goats imported from Canada must not be pregnant, must be less than 12 months of age when imported into the United States and when slaughtered, must be from a flock or herd subject to a ruminant feed ban equivalent to the requirements established by the U.S. Food and Drug Administration at 21 CFR 589.2000, and, before the animal's arrival at the port of entry into the United States, must be officially identified with unique individual identification that is traceable to the premises of origin of the animal. No person may alter, deface, remove, or otherwise tamper with the official identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at the time of slaughter. The animals must be accompanied by the certification issued in accordance with § 93.405 that states, in addition to the statements required by § 93.405, that the conditions of this paragraph have been met. Additionally, for sheep and goats imported for immediate slaughter, the certificate must state that the conditions of paragraphs (d)(1) through (d)(3) of this section have been met, and, for sheep and goats imported for other than immediate slaughter, the certificate must state that the conditions of paragraphs (e)(1) and (e)(2) of this section have been met.

(e)* * *

(2)The animals may be moved from the port of entry only to a feedlot designated in accordance with paragraph (e)(7) of this section and must be accompanied from the port of entry to the designated feedlot by APHIS Form VS 17-130 or other movement documentation deemed acceptable by the Administrator, which must identify the physical location of the feedlot, the individual responsible for the movement of the animals, and the individual identification of each animal, which includes the official identification required under paragraph

(c)of this section and any other identification present on the animal, including registration number, if any:

(5)The animals must be accompanied to the recognized slaughtering establishment by APHIS Form VS 1-27 or other documentation deemed acceptable by the Administrator, which must identify the physical location of the recognized slaughtering establishment, the individual responsible for the movement of the animals, and the individual identification of each animal, which includes the official identification required under paragraph

(c)of this section and any other identification present on the animal, including registration number, if any;

(7)* * *

(i)Will not remove official identification from animals unless medically necessary, in which case new official identification will be applied and cross referenced in the records;

(iii)Will maintain records of the acquisition and disposition of all imported sheep and goats entering the feed lot, including the official identification number and all other identifying information, the age of each animal, the date each animal was acquired and the date each animal was shipped to slaughter, and the name and location of the plant where each animal was slaughtered. For Canadian animals that die in the feedlot, the feedlot will remove the official identification device if affixed to the animal, or will record any other official identification on the animal and place the official identification device or record of official identification in a file with a record of the disposition of the carcass; 5. Section 93.436 is amended by revising paragraphs (a)(2) and (b)(3) to read as set forth below. § 93.436 Ruminants from regions of minimal risk for BSE.

(a)* * *

(2)Before the animal's arrival at the port of entry into the United States, each bovine imported into the United States from a BSE minimal-risk region must be officially identified with unique individual identification that is traceable to the premises of origin of the animal. No person may alter, deface, remove, or otherwise tamper with the official identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at slaughter;

(b)* * *

(3)Before the animal's arrival at the port of entry into the United States, each bovine imported into the United States from a BSE minimal-risk region must be officially identified with unique individual identification that is traceable to the premises of origin of the animal. No person may alter, deface, remove, or otherwise tamper with the official identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at slaughter; PART 94—RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, CLASSICAL SWINE FEVER, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND RESTRICTED IMPORTATIONS 6. The authority citation for part 94 continues to read as follows: Authority: 7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4. 7. In § 94.19, paragraph

(f)is revised to read as follows: § 94.19 Restrictions on importation from BSE minimal-risk regions of meat and edible products from ruminants.

(f)*Gelatin other than that allowed importation under § 94.18(c).* The gelatin is derived from:

(1)The bones of bovines subject to a ruminant feed ban equivalent to the requirements established by the U.S. Food and Drug Administration at 21 CFR 589.2000 and from which SRMs were removed, and the gelatin has not been commingled with materials ineligible for entry into the United States; or

(2)The hides of bovines, and the gelatin has not been commingled with materials ineligible for entry into the United States. PART 95—SANITARY CONTROL OF ANIMAL BYPRODUCTS (EXCEPT CASINGS), AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES 8. The authority citation for part 95 continues to read as follows: Authority: 7 U.S.C. 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4. 9. Section 95.4 is amended as follows: a. Paragraph (c)(2) is revised to read as set forth below. b. Paragraphs (c)(3) through (c)(7) are redesignated as paragraphs (c)(4) through (c)(8), respectively. c. A new paragraph (c)(3) is added to read as set forth below. d. Newly redesignated paragraph (c)(7) is revised to read as set forth below. e. Paragraph (g)(2) is revised to read as set forth below. § 95.4 Restrictions on the importation of processed animal protein, offal, tankage, fat, glands, certain tallow other than tallow derivatives, and blood and blood products due to bovine spongiform encephalopathy.

(c)* * *

(2)In regions listed in § 94.18(a)(1) or (a)(2) of this subchapter as regions in which BSE exists or that present an undue risk of introducing BSE into the United States, all steps of processing and storing the material are carried out in a facility that has not been used for the processing and storage of materials derived from ruminants that have been in any region listed in § 94.18(a) of this subchapter.

(3)In regions listed in § 94.18(a)(3) of this subchapter as BSE minimal-risk regions, all steps of processing and storing the material are carried out in a facility that has not been used for the processing and storage of materials derived from ruminants that have been in any region listed in § 94.18(a)(1) or (a)(2) of this subchapter as a region in which BSE exists or a region that presents an undue risk of introducing BSE into the United States.

(7)Each shipment to the United States is accompanied by an original certificate signed by a full-time, salaried veterinarian of the government agency responsible for animal health in the region of export certifying that the conditions of paragraphs (c)(1) through (c)(4) of this section have been met; except that, for shipments of animal feed from a region listed in § 94.18(a)(3) of this subchapter, the certificate may be signed by a person authorized to issue such certificates by the veterinary services of the national government of the region of origin.

(g)* * *

(2)The tallow is composed of a maximum level of insoluble impurities of 0.15 percent in weight; Done in Washington, DC, this 14th of January 2008. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E8-883 Filed 1-17-08; 8:45 am] BILLING CODE 3410-34-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 23 [Docket No. CE281; Special Conditions No. 23-221-SC] Special Conditions: Embraer S.A., Model EMB-500; Fire Extinguishing for Aft Fuselage Mounted Engines AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final special conditions; request for comments. SUMMARY: These special conditions are issued for the Embraer Model EMB-500 airplane. This airplane will have a novel or unusual design feature(s) associated with aft mounted engine fire protection. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards. DATES: The effective date of these special conditions is January 7, 2008. Comments must be received on or before February 19, 2008. ADDRESSES: Comments on these special conditions may be mailed in duplicate to: Federal Aviation Administration, Regional Counsel, ACE-7, Attention: Rules Docket CE281, 901 Locust, Room 506, Kansas City, Missouri 64106; or delivered in duplicate to the Regional Counsel at the above address. Comments may be inspected in the Rules Docket weekdays, except Federal holidays, between 7:30 a.m. and 4 p.m. FOR FURTHER INFORMATION CONTACT: Peter L. Rouse, Federal Aviation Administration, Aircraft Certification Service, Small Airplane Directorate, ACE-111, 901 Locust, Room 301, Kansas City, Missouri 64106; 816-329-4135, fax 816-329-4090. SUPPLEMENTARY INFORMATION: Comments Invited Interested persons are invited to submit such written data, views, or arguments as they may desire. Identify the regulatory docket or special condition number and submit comments in duplicate to the address specified above. All communications received on or before the closing date for comments will be considered by the Administrator. The special conditions may be changed in light of the comments received. All comments received will be available in the Rules Docket for examination by interested persons, both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerning this rulemaking will be filed in the docket. If you wish the FAA to acknowledge receipt of the comments submitted in response to this notice, include a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. CE281.” The postcard will be date stamped and returned to the commenter. Background On October 5, 2005, Embraer S.A. applied for a type certificate for their new Model EMB-500. The Model EMB-500 is a normal category, low-winged monoplane with “T” tailed vertical and horizontal stabilizers, retractable tricycle type landing gear and twin turbofan engines mounted on the aircraft fuselage. Its design characteristics include a predominance of metallic construction. The maximum takeoff weight is 9,700 pounds, the V <sup>MO</sup> /M <sup>MO</sup> is 275 KIAS/M 0.70 and maximum altitude is 41,000 feet. 14 CFR part 23 has historically addressed fire protection through prevention, identification, and containment. Prevention has been provided through minimizing the potential for ignition of flammable fluids and vapors. Identification has been provided by locating engines within the pilots' primary field of view and/or with the incorporation of fire detection systems. This has provided both rapid detection of a fire and confirmation when it was extinguished. Containment has been provided through the isolation of designated fire zones, through flammable fluid shutoff valves, and firewalls. This containment philosophy also ensures that components of the engine control system will function effectively to permit a safe shutdown of an engine. However, containment has only been demonstrated for 15 minutes. If a fire occurs in traditional part 23 airplanes, the appropriate corrective action is to land as soon as possible. For a small, simple airplane originally envisioned by part 23, it is possible to descend and land within 15 minutes; thus, the occupants can safely exit the airplane before the firewall is breached. These simple airplanes normally have the engine located away from critical flight control systems and primary structure. This has ensured that, throughout a fire event, a pilot can continue safe flight, and it has made the prediction of fire effects relatively easy. Other design features of these simple aircraft, such as low stall speeds and short landing distances, ensure that even if an off-field landing occurs, the potential for the outcome being catastrophic has been minimized. Title 14 CFR part 23 did not envision the type of configuration of the Model EMB-500 airplane. The Model EMB-500 incorporates two turbofan engines located on pylons on either side of the aft fuselage. These engines are not in the pilots' field of view. With the location on the aft fuselage, the ability to visually detect a fire is minimal. Type Certification Basis Under the provisions of 14 CFR 21.17, Embraer S.A. must show that the Model EMB-500 meets the applicable provisions of 14 CFR part 23, as amended by Amendments 23-1 through 23-55, thereto. If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 23) do not contain adequate or appropriate safety standards for the Model EMB-500 because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16. In addition to the applicable airworthiness regulations and special conditions, the Model EMB-500 must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36, and the FAA must issue a finding of regulatory adequacy pursuant to section 611 of Public Law 92-574, the “Noise Control Act of 1972.” Special conditions, as appropriate, as defined in 11.19, are issued under § 11.38, and become part of the type certification basis under § 21.17(a)(2). Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, the special conditions would also apply to the other model under the provisions of § 21.101(a)(1). Novel or Unusual Design Features The Model EMB-500 incorporates two turbofan engines located on pylons on either side of the aft fuselage. These engines are not in the pilots' field of view. The effects of a fire in such a compartment are more varied and adverse than the typical engine fire in a simple part 23 airplane. With the location on the aft fuselage, the ability to visually detect a fire is minimal. However, the ability to extinguish an engine fire becomes extremely critical with the Model EMB-500 engine location. Applicability As discussed above, these special conditions are applicable to the Model EMB-500. Should Embraer S. A. apply later for a change to the type certificate to include another model incorporating the same novel or unusual design feature, the special conditions would apply to that model as well under § 21.101(a)(1). Good Cause The FAA has determined that notice and opportunity for prior public comment hereon are impracticable because these procedures would significantly delay issuance of the design approval and thus delivery of the affected aircraft. In addition, the substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon issuance. Conclusion Under standard practice, the effective date of final special conditions would be 30 days after the date of publication in the **Federal Register** ; however, as the certification date for the Embraer S. A. Model EMB-500 is imminent, the FAA finds that good cause exists to make these special conditions effective upon issuance. This action affects only certain novel or unusual design features on one model, Model EMB-500, of airplane. It is not a rule of general applicability, and it affects only the applicant who applied to the FAA for approval of these features on the airplane. List of Subjects in 14 CFR Part 23 Aircraft, Aviation safety, Signs and symbols. Citation The authority citation for these special conditions is as follows: Authority: 49 U.S.C. 106(g), 40113 and 44701; 14 CFR 21.16 and 21.17; and 14 CFR 11.38 and 11.19. The Special Conditions Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Embraer S. A. Model EMB-500 airplanes. 1. SC 23.1195—Add the requirements of § 23.1195 while deleting the phrase, “For commuter category airplanes.” 23.1195, Fire Extinguishing Systems

(a)Fire extinguishing systems must be installed and compliance shown with the following:

(1)Except for combustor, turbine, and tailpipe sections of turbine-engine installations that contain lines or components carrying flammable fluids or gases for which a fire originating in these sections is shown to be controllable, a fire extinguisher system must serve each engine compartment;

(2)The fire extinguishing system, the quantity of extinguishing agent, the rate of discharge, and the discharge distribution must be adequate to extinguish fires. An individual “one-shot” system may be used; and

(3)The fire extinguishing system for a nacelle must be able to simultaneously protect each compartment of the nacelle for which protection is provided.

(b)If an auxiliary power unit is installed in any airplane certificated to this part, that auxiliary power unit compartment must be served by a fire extinguishing system meeting the requirements of paragraph (a)(2) of this section. 2. SC 23.1197—Add the requirements of § 23.1197 while deleting the phrase, “For commuter category airplanes.” 23.1197, Fire Extinguishing Agents The following applies:

(a)Fire extinguishing agents must—

(1)Be capable of extinguishing flames emanating from any burning fluids or other combustible materials in the area protected by the fire extinguishing system; and

(2)Have thermal stability over the temperature range likely to be experienced in the compartment in which they are stored.

(b)If any toxic extinguishing agent is used, provisions must be made to prevent harmful concentrations of fluid or fluid vapors (from leakage during normal operation of the airplane or as a result of discharging the fire extinguisher on the ground or in flight) from entering any personnel compartment, even though a defect may exist in the extinguishing system. This must be shown by test except for built-in carbon dioxide fuselage compartment fire extinguishing systems for which—

(1)Five pounds or less of carbon dioxide will be discharged under established fire control procedures into any fuselage compartment; or

(2)Protective breathing equipment is available for each flight crewmember on flight deck duty. 3. SC 23.1199—Add the requirements of § 23.1199 while deleting the phrase, “For commuter category airplanes.” 23.1199, Extinguishing Agent Containers The following applies:

(a)Each extinguishing agent container must have a pressure relief to prevent bursting of the container by excessive internal pressures.

(b)The discharge end of each discharge line from a pressure relief connection must be located so that discharge of the fire-extinguishing agent would not damage the airplane. The line must also be located or protected to prevent clogging caused by ice or other foreign matter.

(c)A means must be provided for each fire extinguishing agent container to indicate that the container has discharged or that the charging pressure is below the established minimum necessary for proper functioning.

(d)The temperature of each container must be maintained, under intended operating conditions, to prevent the pressure in the container from—

(1)Falling below that necessary to provide an adequate rate of discharge; or

(2)Rising high enough to cause premature discharge.

(e)If a pyrotechnic capsule is used to discharge the fire extinguishing agent, each container must be installed so that temperature conditions will not cause hazardous deterioration of the pyrotechnic capsule. 4. SC 23.1201—Add the requirements of § 23.1201 while deleting the phrase, “For commuter category airplanes.” 23.1201, Fire Extinguishing System Materials The following apply:

(a)No material in any fire extinguishing system may react chemically with any extinguishing agent so as to create a hazard.

(b)Each system component in an engine compartment must be fireproof. Issued in Kansas City, Missouri on January 7, 2008. John Colomy, Acting Manager, Small Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-849 Filed 1-17-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products CFR Correction In Title 21 of the Code of Federal Regulations, Parts 800 to 1299, revised as of April 1, 2007, in part 1271, on page 718, § 1271.22 is reinstated to read as follows: § 1271.22 How and where do I register and submit an HCT/P list?

(a)You must use Form FDA 3356 for:

(1)Establishment registration,

(2)HCT/P listings, and

(3)Updates of registration and HCT/P listing.

(b)You may obtain Form FDA 3356:

(1)By writing to the Center for Biologics Evaluation and Research (HFM-775), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, Attention: Tissue Establishment Registration Coordinator;

(2)By contacting any Food and Drug Administration district office;

(3)By calling the CBER Voice Information System at 1-800-835-4709 or 301-827-1800; or

(4)By connecting to *http://www.fda.gov/opacom/morechoices/fdaforms/cber.html* on the Internet. (c)(1) You may submit Form FDA 3356 to the Center for Biologics Evaluation and Research (HFM-775), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, Attention: Tissue Establishment Registration Coordinator; or

(2)You may submit Form FDA 3356 electronically through a secure web server at *http://www.fda.gov/cber/tissue/tisreg.htm* . [69 FR 68681, Nov. 24, 2004] [FR Doc. 08-55500 Filed 1-17-08; 8:45 am]

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