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Code · REGISTER · 2011-03-25 · PROPOSED RULES · Agency Health Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 16778-16785 2011-6848 2011-6855 2011-6857 Meetings: So · Unknown

Unknown. Interim rule and request for comments

6,237 words·~28 min read·/register/2011/03/25/2011-7098·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2011-03-25.xml --- 76 58 Friday, March 25, 2011 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 16778-16785 2011-6848 2011-6855 2011-6857 Meetings: Software Developers on Technical Specifications for Common Formats for Patient Safety Data Collection and Event Reporting, 16785-16787 2011-6852 Agency Agency for International Development PROPOSED RULES Participation by Religious Organizations in USAID Programs, 16712-16714 2011-6974 Agriculture Agriculture Department See Animal and Plant Health Inspection Service See Food and Nutrition Service See Forest Service Animal Animal and Plant Health Inspection Service RULES Importation of Horses from Contagious Equine Metritis-Affected Countries, 16683-16686 2011-7098 PROPOSED RULES Importation of French Beans and Runner Beans from the Republic of Kenya into the U.S., 16700-16703 2011-7088 Antitrust Division Antitrust Division NOTICES National Cooperative Research and Production Act, 1993:
Connected Media Experience, Inc., 16819 2011-6922 Consortium for Energy, Environment and Demilitarization, 16819-16820 2011-6921 Interchangeable Virtual Instruments Foundation, Inc., 16820 2011-6917 National Warheads and Energetics Consortium, 16820 2011-6916 PXI Systems Alliance, Inc., 16820-16821 2011-6915 Army Army Department See Engineers Corps Arts and Humanities, National Foundation See National Foundation on the Arts and the Humanities Blind or Severely Disabled, Committee for Purchase From People Who Are See Committee for Purchase From People Who Are Blind or Severely Disabled Centers Disease Centers for Disease Control and Prevention NOTICES Meetings:
Advisory Board on Radiation and Worker Health, 16787 2011-7076 Subcommittee for Dose Reconstruction Reviews, 16787-16788 2011-7075 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Advisory Panel on Ambulatory Payment Classification Groups; Nominations, 16788-16789 2011-6811 Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2011-7095 16789-16793 2011-7099 2011-7104 2011-7106 Medicare and Medicaid Programs: Renewal of Deeming Authority of the National Committee for Quality Assurance, etc., 16793-16795 2011-6222 Children Children and Families Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Voluntary Establishment of Paternity, 16795 2011-7077 Coast Guard Coast Guard RULES Passenger Weight and Inspected Vessel Stability Requirements; Correction, 16697-16698 2011-7048 PROPOSED RULES Drawbridge Operation Regulations: Raritan River, Arthur Kill and Their Tributaries, Staten Island, NY and Elizabeth, NJ, 16715-16718 2011-7049 Commerce Commerce Department See Foreign-Trade Zones Board See Industry and Security Bureau See International Trade Administration See National Institute of Standards and Technology See National Oceanic and Atmospheric Administration Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List;
Proposed Additions and Deletions, 16733-16734 2011-7093 Committee Implementation Committee for the Implementation of Textile Agreements NOTICES Determinations: Dominican Republic-Central America-United States Free Trade Agreement, 16734-16735 2011-7142 Consumer Product Consumer Product Safety Commission NOTICES Meetings; Sunshine Act, 2011-7158 16735 2011-7159 Defense Department Defense Department See Engineers Corps See Navy Department PROPOSED RULES Reducing Regulatory Burden;
Retrospective Review under E.O. 13563, 16700 2011-7051 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Certification of Independent Price Determination and Parent Company and Identifying Data, 16735-16736 2011-7079 Meetings: Missile Defense Advisory Committee, 16736 2011-7054 Renewal of Department of Defense Federal Advisory Committees, 16737 2011-7050 Drug Drug Enforcement Administration NOTICES Decision and Order: Gregory F. Saric, MD, 16821-16823 2011-7016 Denial of Application:
Robert L. Dougherty, MD, 16823-16835 2011-7014 Revocations of Registrations: Erwin E. Feldman, DO, 16835-16838 2011-7047 Education Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 16740-16741 2011-7105 Applications for New Awards: Erma Byrd Scholarship Program, 16741-16743 2011-7126 Hispanic-Serving Institutions STEM and Articulation Programs, 16747-16754 2011-7127 International and Foreign Language Education Service, 16743-16747 2011-7128 CSP Grants for Replication and Expansion of High-Quality Charter Schools, 16754-16758 2011-7125 Energy Department Energy Department See Energy Efficiency and Renewable Energy Office See Federal Energy Regulatory Commission NOTICES Defense Nuclear Facilities Safety Board;
Response to Recommendation: Safety Analysis Requirements for Defining Adequate Protection for the Public and the Workers, 16758-16760 2011-7085 Energy Efficiency Energy Efficiency and Renewable Energy Office NOTICES Energy Conservation Program for Consumer Products; Waivers: Samsung from Residential Refrigerator and Refrigerator-Freezer Test Procedure, 16760-16763 2011-7089 Meetings: State Energy Advisory Board, 16763-16764 2011-7086 Engineers Engineers Corps NOTICES Environmental Impact Statements;
Availability, etc.: Proposed South Coast Rail Project, Commonwealth of Massachusetts, 16737-16739 2011-7070 Environmental Protection Environmental Protection Agency RULES California State Implementation Plan; Revisions: San Joaquin Valley Unified Air Pollution Control District, 16696-16697 2011-7090 PROPOSED RULES Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality Planning Purposes: Georgia: Atlanta; Determination of Attainment for the 1997 8-Hour Ozone Standards, 16718-16722 2011-7114 NOTICES Environmental Impact Statements;
Availability, etc.: Weekly Receipt, 16767-16768 2011-7115 Meetings: Clean Air Scientific Advisory Committee; Teleconference, 16768-16769 2011-7092 Oil Spill Research Strategy Review Panel, 16769-16770 2011-7094 Petition to Suspend and Cancel All Registrations for the Soil Fumigant Iodomethane; Availability, 16770-16771 2011-7117 Equal Equal Employment Opportunity Commission RULES Equal Employment Provisions of the Americans with Disabilities Act, as amended, 16978-17017 2011-6056 Export Import Export-Import Bank NOTICES Meetings;
Sunshine Act, 16771 2011-7122 Federal Aviation Federal Aviation Administration RULES Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments, 16686-16691 2011-6112 2011-6117 NOTICES Passenger Facility Charge Applications: Bob Hope Airport, Burbank, CA, 16851-16852 2011-7062 Waivers of Aeronautical Land-Use Assurances: Marv Skie-Lincoln County Airport, Tea, SD, 16852 2011-7058 Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 16771-16776 2011-6987 2011-6988 2011-6989 Federal Emergency Federal Emergency Management Agency PROPOSED RULES Flood Elevation Determinations; Correction, 16722-16723 2011-7082 NOTICES Major Disaster Declarations Utah; Amendment No. 1, 16798-16799 2011-7011 Federal Energy Federal Energy Regulatory Commission RULES Western Electric Coordinating Council: Qualified Transfer Path Unscheduled Flow Relief Regional Reliability Standard, 16691-16696 2011-7040 NOTICES Applications:
Crane and Company, 16764-16765 2011-7042 Environmental Assessments; Availability, etc.: Leader One Gas Storage Project, Adams County, CO, 16765-16766 2011-7045 Preliminary Permit Applications: ECOsponsible, Inc., 16766-16767 2011-7043 2011-7044 Requests to Use Traditional Licensing Process: City of Loveland, CO, 16767 2011-7041 Federal Motor Federal Motor Carrier Safety Administration NOTICES Assessments of Safety Impact of Exemptions from the 14-Hour Provision of the Hours of Service Rule:
Certain Pyrotechnics Operations During Independence Day Celebrations, 16852-16854 2011-7009 Federal Reserve Federal Reserve System PROPOSED RULES Availability of Funds and Collection of Checks, 16862-16976 2011-5449 NOTICES Change in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 16776 2011-7059 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 16776 2011-7060 Federal Transit Federal Transit Administration NOTICES Meetings: Transit Rail Advisory Committee for Safety, 16854-16855 2011-7027 Food and Drug Food and Drug Administration NOTICES National Antimicrobial Resistance Monitoring System Strategic Plan 2011-2015, 16795-16796 2011-7068 Pediatric Anesthesia Safety Initiative, 16796-16797 2011-7055 Food and Nutrition Food and Nutrition Service NOTICES Child Nutrition Programs:
Income Eligibility Guidelines, 16724-16725 2011-6948 Foreign Assets Foreign Assets Control Office NOTICES Unblocking of One Specially Designated Global Terrorist Pursuant to Executive Order 13224, 16855 2011-7096 Foreign Trade Foreign-Trade Zones Board NOTICES Applications for Reorganization under Alternative Site Framework: Foreign-Trade Zone 41, Milwaukee, WI, 16726-16727 2011-7139 Forest Forest Service NOTICES Meetings: Eleven Point Resource Advisory Committee, 16726 2011-7061 Ravalli County Resource Advisory Committee, 16725 2011-7072 General Services General Services Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Certification of Independent Price Determination and Parent Company and Identifying Data, 16735-16736 2011-7079 Health and Human Health and Human Services Department See Agency for Healthcare Research and Quality See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Children and Families Administration See Food and Drug Administration See National Institutes of Health NOTICES Meetings: Advisory Group on Prevention, Health Promotion, and Integrative and Public Health, 16776-16777 2011-7026 Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020, 16777-16778 2011-7074 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency See Transportation Security Administration See U.S.
Citizenship and Immigration Services Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Public Housing Inventory Removal Application, 16801-16802 2011-7015 Section 5(h) Homeownership Program for Public Housing, Submission of Plan and Reporting, 16800-16801 2011-7013 Federal Property Suitable as Facilities to Assist Homeless, 16802 2011-6761 Industry Industry and Security Bureau NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Procedures for Acceptance or Rejection of Rated Order, 16727 2011-7021 Interior Interior Department See Land Management Bureau See National Park Service See Office of Natural Resources Revenue See Reclamation Bureau See Surface Mining Reclamation and Enforcement Office Internal Revenue Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 16855-16856 2011-6997 2011-7111 International Trade Adm International Trade Administration NOTICES Extension of Time Limit for Preliminary Results of Antidumping Duty New Shipper Reviews:
Certain Preserved Mushrooms from the People's Republic of China, 16727-16728 2011-7131 Request for NAFTA Panel Review, 16728 2011-7024 Justice Department Justice Department See Antitrust Division See Drug Enforcement Administration See Prisons Bureau Labor Department Labor Department See Workers Compensation Programs Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Longshore and Harbor Workers Compensation Act Pre-Hearing Statement, 16840-16841 2011-7039 Petition for Classifying Labor Surplus Areas, 16839-16840 2011-7132 Land Land Management Bureau NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 16802-16803 2011-7038 Alaska Native Claims Selections, 16804-16805 2011-7002 2011-7004 2011-7006 2011-6999 Call for Nominations: California Desert District Advisory Council, 16805-16806 2011-6994 Environmental Impact Statements; Availability, etc.: Proposed Casa Diablo IV Geothermal Development Project, Mammoth Lakes, Mono County, CA, 16806-16807 2011-7012 Fees on Public Land in Tangle Lakes, AK, 16807-16808 2011-7008 Invitation to Participate In Coal Exploration License, Utah, 16808-16809 2011-6998 Meetings:
Twin Falls District Resource Advisory Council, Idaho, 16809 2011-7073 Realty Actions: Application for a Recordable Disclaimer of Interest in Land; Wyoming, 16811 2011-7000 Direct Sale of Public Lands in Santa Clara County, CA, 16811-16812 2011-7017 Lease and Conveyance of Public Land, Mohave County, AZ, 16809-16810 2011-7022 Modified Competitive Bid Sale of Public Land in Santa Clara County, CA, 16812-16813 2011-7001 Non-Competitive (Direct) Sale of Public Land in Hot Springs County, WY, 16810-16811 2011-7007 NASA National Aeronautics and Space Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Certification of Independent Price Determination and Parent Company and Identifying Data, 16735-16736 2011-7079 Meetings: Science Committee, Planetary Science Subcommittee, 16841-16842 2011-7037 National Foundation National Foundation on the Arts and the Humanities NOTICES Meetings: Arts Advisory Panel, 16842 2011-7035 National Institute National Institute of Standards and Technology NOTICES American Petroleum Institute's Standards Activities, 16728-16730 2011-7121 National Institute National Institutes of Health NOTICES Meetings:
Center for Scientific Review, 16798 2011-7133 National Center for Research Resources, 16797-16798 2011-7137 National Institute of Allergy and Infectious Diseases, 16798 2011-7136 National Institute on Alcohol Abuse and Alcoholism, 16798 2011-7134 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: Shrimp Fishery off the Southern Atlantic States; Closure of the Penaeid Shrimp Fishery off South Carolina, 16698-16699 2011-7118 Fisheries of the Exclusive Economic Zone Off Alaska:
Pollock in Statistical Area 620 in the Gulf of Alaska; Closure, 16699 2011-7116 NOTICES Meetings: South Atlantic Fishery Management Council, 16730-16731 2011-7083 National Sea Grant Advisory Board; Nominations, 16731 2011-7071 National System of Marine Protected Areas; Updates, 16732-16733 2011-7036 National Park National Park Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 16813-16816 2011-7112 Navy Navy Department NOTICES Privacy Act;
Systems of Records, 16739-16740 2011-7053 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Request for a License to Export Reactor Components, 16842-16843 2011-7084 Office of Natural Resources Revenue NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 16816-16818 2011-7140 Prisons Prisons Bureau NOTICES Environmental Assessment; Availability: Proposed Contract for New Low Security Beds to House 1,000 Federal Non-US Citizen, Criminal Aliens, 16838-16839 2011-6819 Reclamation Reclamation Bureau NOTICES Standard Criteria for Ag and Urban Water Management Plans;
Availability, 16818-16819 2011-7078 Securities Securities and Exchange Commission PROPOSED RULES Transfer Agents', Brokers', and Dealers' Obligation to Search for Lost Securityholders, etc., 16707-16712 2011-6940 NOTICES Order Cancelling Registrations of Certain Transfer Agents, 16843-16844 2011-7100 Self-Regulatory Organizations; Proposed Rule Changes: NASDAQ OMX BX, Inc., 16844-16845 2011-7109 Small Business Small Business Administration PROPOSED RULES Small Business Jobs Act Tour:
Selected Provisions Having an Effect on Government Contracting, 16703-16707 2011-7135 NOTICES Administrators Line of Succession Designation, No. 1-A, Revision 32, 16845-16846 2011-7067 Disaster Declarations: Illinois, 16846-16847 2011-7064 Ohio, 16846 2011-7063 Social Social Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 16847-16850 2011-7123 2011-7124 State Department State Department NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: NEA/PI Online Performance Reporting System, 16850-16851 2011-7101 Culturally Significant Objects Imported for Exhibition Determinations: Seeing Gertrude Stein; Five Stories, 16851 2011-7103 Surface Mining Surface Mining Reclamation and Enforcement Office PROPOSED RULES Pennsylvania Regulatory Program, 16714-16715 2011-7107 Textile Agreements Implementation Committee See Committee for the Implementation of Textile Agreements Transportation Department Transportation Department See Federal Aviation Administration See Federal Motor Carrier Safety Administration See Federal Transit Administration See Transportation Security Administration Security Transportation Security Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Claims Management Program, 16799-16800 2011-7141 Treasury Treasury Department See Foreign Assets Control Office See Internal Revenue Service U.S. Citizenship U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 16800 2011-7010 U.S. China U.S.-China Economic and Security Review Commission NOTICES Hearings: Chinese State-Owned Enterprises and U.S.-China Bilateral Investment, 16856-16857 2011-7129 Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Application for Change of Permanent Plan (Medical), 16860 2011-7034 Certification of School Attendance—REPS, 16859 2011-7032 Payment Not Applied Notice, 16857 2011-7028 Request for Contact Information, 16857-16858 2011-7029 Statement of Marital Relationship, 16858-16859 2011-7031 Supplemental Income Questionnaire (for Philippine Claims Only), 16858 2011-7030 Veteran's Supplemental Application for Assistance in Acquiring Specially Adapted Housing, 16859-16860 2011-7033 Workers' Workers Compensation Programs Office NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 16841 2011-7046 Separate Parts In This Issue Part II Federal Reserve System, 16862-16976 2011-5449 Part III Equal Employment Opportunity Commission, 16978-17017 2011-6056 Reader Aids Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws. To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 76 58 Friday, March 25, 2011 Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 93 [Docket No.
APHIS-2008-0112] RIN 0579-AD31 Importation of Horses From Contagious Equine Metritis-Affected Countries AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Interim rule and request for comments. SUMMARY: We are amending the regulations regarding the importation of horses from countries affected with contagious equine metritis
(CEM)by incorporating an additional certification requirement for imported horses 731 days of age or less and adding new testing protocols for test mares and imported stallions and mares more than 731 days of age. We are taking these actions in response to incidents that prompted an investigation by an expert review panel, which identified specific weaknesses in the current regulations. This action will provide additional safeguards against the introduction of CEM through the importation of affected horses. DATES: This interim rule is effective March 25, 2011. We will consider all comments that we receive on or before May 24, 2011. ADDRESSES: You may submit comments by either of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0112* to submit or view comments and to view supporting and related materials available electronically. • *Postal Mail/Commercial Delivery:* Please send one copy of your comment to Docket No. APHIS-2008-0112, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2008-0112. *Reading Room:* You may read any comments that we receive on this docket in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue, SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call
(202)690-2817 before coming. *Other Information:* Additional information about APHIS and its programs is available on the Internet at *http://www.aphis.usda.gov.* FOR FURTHER INFORMATION CONTACT: Dr. Ellen Buck, Senior Staff Veterinarian, Equine Imports, National Center for Import and Export, VS, APHIS, 4700 River Road, Unit 36, Riverdale, MD 20737-1231;
(301)734-8364. SUPPLEMENTARY INFORMATION: Background The regulations in 9 CFR part 93 (referred to below as the regulations) prohibit or restrict the importation of certain animals into the United States to prevent the introduction of communicable diseases of livestock. Subpart C—Horses, §§ 93.300 through 93.326, pertains to the importation of horses into the United States. Sections 93.301 and 93.304 of the regulations contain specific provisions for the importation of horses from regions affected with contagious equine metritis (CEM), which is a highly contagious venereal disease of horses and other equines caused by an infection with the bacterium *Taylorella equigenitalis.* The regulations provide that some types of horses may be imported from CEM-affected regions without restriction. For instance, weanlings and yearlings are exempt under § 93.301(c)(2)(iii). Other horses are allowed to be imported from CEM-affected regions provided they meet certain requirements that include quarantine, testing, and treatment as provided under § 93.301(d), (e), and (f). Horses that fall under this category include Spanish Pure Breed horses from Spain; racing thoroughbreds from Germany, France, Ireland, and the United Kingdom; stallions and mares over 731 days of age; and horses that are imported under special provisions for temporary importation for competition or entertainment purposes. Approximately 2,500 horses imported from CEM-affected regions undergo CEM quarantine in the United States each year. Over the past 10 years, despite current requirements for pre-import CEM testing in the country of origin, more than 28 CEM-positive horses have been identified during quarantine in the United States. In 2006, a private veterinarian in the United States detected a *T. equigenitalis* infection during a routine breeding soundness exam of an imported stallion that had been released from CEM quarantine in 2004 after testing negative for CEM. The epidemiological investigation that followed detected two other infected stallions on the same premises. This incident jeopardized the CEM-free status of the United States and had a significant impact on U.S. horse exports. In 2007, in response to this incident, APHIS' Veterinary Services program initiated a review and assessment by Federal, State, and industry officials of U.S. equine import activities to identify any improvements to testing procedures that may be necessary to better mitigate the risk of a CEM-positive horse being released into the U.S. equine population. A second incident indicating a need to strengthen the CEM regulations occurred in April 2008 when an imported mare undergoing CEM quarantine demonstrated positive results for CEM on a complement-fixation
(CF)test, which has not been required for imported mares under the regulations; the required sampling of the clitoral sinuses and clitoral fossa of the mare had shown negative results for *T. equigenitalis.* The attending veterinarian administered the CF test because she knew about the recommendations that followed from the review and assessment of the 2006 incident. In December 2008, a U.S. origin stallion with no history of residence in a CEM-affected region was undergoing routine testing for semen export, and cultured positive for CEM. APHIS initiated an epidemiologic investigation to identify other potentially infected horses. Ultimately 23 stallions and 5 mares were identified as infected. An additional 250 stallions and 718 mares were identified as exposed to positive horses. All infected or exposed horses required culturing and treatment at their owners' expense. The suspected source of the outbreak was a stallion imported from Denmark in late 2000 whose CEM infection was not detected on import testing. Because of the outbreak, some countries no longer recognized the United States as CEM-free and consequently placed restrictions on U.S. equine exports. The 2006 and 2008 incidents indicate that the regulations that have been in place are inadequate to identify all imported horses infected with *T. equigenitalis.* Given the incidents noted above, we have determined that the following regulatory changes are necessary and need to be implemented immediately in order to prevent the potential introduction and spread of CEM in the United States. Exemption for Weanlings and Yearlings The regulations in § 93.301(c)(2)(iii) have exempted weanlings or yearlings (defined as not more than 731 days of age) from CEM quarantine requirements when their age is certified on the import health certificate required under § 93.314(a). The regulations have provided for this exemption because horses less than 2 years old have generally been considered too young to breed and therefore pose only a minimal risk of entering the United States with a venereal disease such as CEM. However, this assumption is now in question because APHIS has identified imported mares 731 days or less of age that were pregnant and therefore at risk of CEM infection. While retaining the current certification-of-age requirement, we are limiting the exemption from CEM-related restrictions to weanlings and yearlings that have never been bred, and we are requiring that their breeding status be certified on the import health certificate required under § 93.314(a). This change to the regulations provides an additional safeguard against the spread of CEM to the U.S. horse population. Imported Stallions Because stallions do not show clinical signs of CEM after becoming exposed to the bacterium *T. equigenitalis,* diagnosis of CEM cannot be based on clinical signs alone. Furthermore, culture tests do not always detect *T. equigenitalis.* The stallion can look normal and test negative for *T. equigenitalis,* but still infect the mare to which it is bred naturally or by artificial insemination. Therefore, the regulations under § 93.301(e) provide that stallions over 731 days of age from CEM-affected regions are to be bred to two test mares. Specifically, the regulations in paragraph (e)(3)(i) have stated that upon arrival at a CEM facility in an approved State, a set of specimens must be taken from a stallion's prepuce, urethral sinus, and fossa glandis, and that after negative culture results have been obtained, the stallion must be test bred to two test mares. After being test bred, a stallion that cultured negative prior to being test bred has not been required to undergo another culture to test for *T. equigenitalis* unless a test mare tested positive for CEM, in which case the stallion would be treated for CEM and the testing process begun again. We are amending paragraph (e)(3)(i) of § 93.301 to require a fourth specimen to be taken from the stallion's distal urethra and to increase the number of required sets of specimens (a set consists of one culture swab from each location) from imported stallions from one set to three sets at each of the four sites, all taken within a 12-day period with a minimum of 72 hours between each set. At least two of the three sets of specimens must be collected from the stallion, with negative results, before the stallion is bred to two test mares. If the test mares test negative for CEM after breeding, and if all of the stallion's culture specimens test negative for CEM, then the stallion will be released from quarantine. These changes to the regulations will increase the likelihood of detecting *T. equigenitalis* in imported stallions, thereby reducing the risk that imported stallions will be released from quarantine with undiagnosed CEM infections. Test Mares Test mares are mares used to test stallions for CEM. To qualify to become a test mare, each mare must test negative for CEM as provided under § 93.301(e)(4). The regulations in § 93.301(e)(3)(i)(B) have required that the mucosal surfaces of the clitoral sinuses and clitoral fossa of a test mare must be cultured for *T. equigenitalis* on the third, sixth, and ninth days after breeding with an imported stallion in CEM quarantine. To increase the likelihood of detecting CEM in test mares, we are amending the regulations to require that either the distal cervix or endometrium be cultured for CEM in addition to the clitoral sinuses and clitoral fossa. We are also extending the allowable timeframe in (e)(4)(ii) to complete all three culture sets from the current 7-day period to a 12-day period, with specimens collected anytime between the third and the fourteenth day after breeding, with a minimum of 72 hours between each set. The additional time allowed to collect all culture samplings was added at the request of the veterinarians, because the 7-day timeframe did not allow any flexibility in scheduling, since samples generally could not be shipped or processed on weekends. Extending the timeframe from 7 days to 12 days to account for the laboratory's hours of operations will help decrease testing delays caused by unusable samples. Furthermore, the regulations in paragraph (e)(3)(i)(B) have required the blood sample for the required CF test to be drawn from the test mare on the fifteenth day after breeding. We are amending the paragraph to require that a test mare's blood be drawn for a CF test on the twenty-first day after breeding. This amendment aligns our requirements with the World Organization for Animal Health's
(OIE)Manual of Diagnostic Tests, 1 which recommends screening mares between 21 and 45 days after breeding. 1 To view the OIE *Terrestrial Animal Health Code,* go to *http://www.oie.int/eng/normes/mcode/en_sommaire.htm.* Imported Mares Once an imported mare has arrived at a CEM quarantine facility in an approved State, the regulations in § 93.301(e)(5)(i) have required specimens to be collected from the mucosal surfaces of the clitoral sinuses and clitoral fossa on days 1, 4, and 7 during a 7-day period with all culture sets received by an approved laboratory within 48 hours of collection. To increase the likelihood of detecting CEM in these imported mares, we are adding a requirement, as we are doing for test mares, to collect specimens from either the distal cervix or the endometrium in nonpregnant mares in addition to the specimens taken from the mucosal surfaces of the clitoral sinuses and clitoral fossa. To help avoid test delays and unusable samples due to facility and laboratory hours of operations, we are extending the timeframe to complete sampling from the current 7-day period to a 12-day period with no less than 72 hours between each set. In addition, we are now requiring that an imported mare be given a CF test upon arrival at a State's CEM quarantine facility. CF testing will allow identification of antibodies from any recent exposure to CEM and provide supplementary information concerning the mare's CEM status. Spanish Pure Breed Horses and Thoroughbred Horses; Horses Temporarily Imported for Competition or Entertainment Purposes To reflect the changes discussed above, we are amending paragraph (d)(1)(ii)(D) in § 93.301 to require that Spanish Pure Breed horses from Spain and thoroughbred horses over 731 days of age from France, Germany, Ireland, and the United Kingdom, test negative for CEM based on the culturing of three sets of specimens. For female horses, the specimens must be collected from the mucosal surfaces of the clitoral fossa, distal cervix or endometrium, and the clitoral sinuses; for any male horses, the specimens must be collected from the surfaces of the prepuce, the urethral sinus, the distal urethra, and the fossa glandis, including the diverticulum of the fossa glandis. For both female and male horses, the sets of specimens must be collected on three separate occasions within a 12-day period with no less than 72 hours between each set, and the last of these sets of specimens must be collected within 30 days prior to the exportation of the horses to the United States. All specimens must be collected by a licensed veterinarian who either is, or is acting in the presence of, the veterinarian signing the required health certificate. We are making similar changes to paragraph (f)(3) in § 93.301, which contains special provisions for temporary importation of horses for competition or entertainment purposes. Specifically, we will require that such horses be accompanied by a health certificate that certifies that cultures negative for CEM were obtained from three sets of specimens. For female horses, the specimens must be collected from the mucosal surfaces of the clitoral fossa and clitoral sinuses, with one set of specimens including a specimen from the surfaces of the distal cervix or endometrium; for male horses, the specimens must be collected from the surfaces of the prepuce, the urethral sinus, the distal urethra, and the fossa glandis, including the diverticulum of the fossa glandis. For both female and male horses, the sets of specimens must be collected on three separate occasions within a 12-day period with no less than 72 hours between each set, and the last of these sets of specimens must be collected within 30 days prior to the exportation of horses to the United States. All specimens must be collected by a licensed veterinarian who either is, or is acting in the presence of, the veterinarian signing the certificate. These changes, which represent an increase in the number of specimens that must be collected, are consistent with the changes we are making for other mares and stallions being imported from CEM-affected regions to the United States and will provide additional safeguards against the spread of CEM to the U.S. horse population. Emergency Action This rulemaking is necessary on an emergency basis to prevent the introduction and spread of CEM into the equine population of the United States. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this rule effective less than 30 days after publication in the **Federal Register** . We will consider comments we receive during the comment period for this interim rule ( *see* DATES above). After the comment period closes, we will publish another document in the **Federal Register.** The document will include a discussion of any comments we receive and any amendments we are making to the rule. Executive Order 12866 and Regulatory Flexibility Act This interim 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. We have prepared an initial regulatory flexibility analysis for this action. The analysis identifies U.S. importers of mares and stallions from CEM countries as the small entities most likely to be affected by this action and considers the costs associated with complying with new requirements. Based on the information presented in the analysis, we expect that U.S. importers will experience a slight increase in quarantine and treatment costs as a result of this action. The overall impact of the additional costs for the horse industry is not expected to be significant, given the relatively small number of horses imported from CEM countries. We invite comment on our initial regulatory flexibility analysis, which is posted with this interim rule on the Regulations.gov Web site ( *see* ADDRESSES above for instructions for accessing Regulations.gov) and may be obtained from the person listed under FOR FURTHER INFORMATION CONTACT. Executive Order 12988 This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule:
(1)Preempts all State and local laws and regulations that are in conflict 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 interim rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). List of Subjects in 9 CFR Part 93 Animal diseases, Imports, Livestock, Poultry and poultry products, Quarantine, Reporting and recordkeeping requirements. Accordingly, we are amending 9 CFR part 93 as follows: PART 93—IMPORTATION OF CERTAIN ANIMALS, BIRDS, FISH, AND POULTRY, AND CERTAIN ANIMAL, BIRD, AND POULTRY PROUDUCTS; 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 93.301 is amended as follows: a. By revising paragraph (c)(2)(iii); b. By revising paragraph (d)(1)(ii)(D); c. In paragraph (e)(1)(iii), by adding the words “distal urethra,” after the words “urethral sinus,” in the second sentence; d. By revising paragraphs (e)(3)(i) introductory text, (e)(3)(i)(B), (e)(4)(ii), and (e)(5)(i); and e. By revising paragraphs (f)(3). The revisions read as follows: § 93.301 General prohibitions; exceptions.
(c)* * *
(2)* * *
(iii)Weanlings or yearlings that have never been used for breeding, and whose age and breeding status are certified on the import health certificate required under § 93.314(a);
(d)* * *
(1)* * *
(ii)* * *
(D)For Spanish Pure Breed horses and thoroughbred horses over 731 days of age, cultures negative for CEM were obtained from three sets of specimens collected within a 12-day period from the mucosal surfaces of the clitoral fossa, distal cervix or endometrium, and the clitoral sinuses of any female horses and from the surfaces of the prepuce, the urethral sinus, the distal urethra, and the fossa glandis, including the diverticulum of the fossa glandis, of any male horses. For both male and female horses, the sets of specimens must be taken within a 12-day period with no less than 72 hours between each set, and the last of these sets of specimens must be collected within 30 days prior to exportation. All specimens required by this paragraph must be collected by a licensed veterinarian who either is, or is acting in the presence of, the veterinarian signing the certificate; and
(e)* * *
(3)* * *
(i)Once the stallion is in the approved State, three sets of specimens consisting of one culture swab from each location shall be taken from the prepuce, the urethral sinus, the distal urethra, and the fossa glandis, including the diverticulum of the fossa glandis, of the stallion and be cultured for CEM. The sets of specimens must be collected on three separate occasions within a 12-day period with no less than 72 hours between each set. No sooner than after the second set of specimens is collected and cultured for CEM with negative results, the stallion must be test bred to two test mares that meet the requirements of paragraph (e)(4) of this section. Upon completion of the test breeding:
(B)Each mare to which the stallion has been test bred shall be cultured for CEM from three sets of specimens from the mucosal surfaces of the clitoral fossa, clitoral sinuses, and from either the distal cervix or endometrium between the third and fourteenth day after breeding, with negative results. The sets of specimens must be collected on three separate occasions within a 12-day period with no less than 72 hours between each set. A complement fixation test for CEM must be done with negative results on the twenty-first day after the breeding.
(4)* * *
(ii)The test mares must be qualified prior to breeding as apparently free from CEM and may not be used for breeding from the time specimens are taken to qualify the mares as free from CEM. To qualify, each mare shall be tested with negative results by a complement fixation test for CEM, and specimens taken from each mare shall be cultured negative for CEM. For each culture, sets of specimens shall be collected on three separate occasions from the mucosal surfaces of the clitoral fossa, clitoral sinuses, and from either the distal cervix or endometrium within a 12-day period with no less than 72 hours between each set.
(5)* * *
(i)Once the mare is in the approved State, a complement fixation test for CEM must be done, and three sets of specimens shall be collected from the mucosal surfaces of the clitoral fossa and clitoral sinuses, with one set of specimens including a specimen from the surfaces of the distal cervix or endometrium in nonpregnant mares. The sets of specimens must be collected on three separate occasions within a 12-day period with no less than 72 hours between each set. An accredited veterinarian shall collect specimens and shall submit each set of specimens to the National Veterinary Services Laboratories in Ames, IA, or to a laboratory approved by the Administrator in accordance with paragraph
(i)of this section to conduct CEM cultures and tests.
(f)* * *
(3)At the time of importation, each horse must be accompanied by an import permit in accordance with § 93.304 and a health certificate issued in accordance with § 93.314. For horses imported in accordance with paragraph (f)(2) of this section, the health certificate must also certify that cultures negative for CEM were obtained from three sets of specimens collected from the mucosal surfaces of the clitoral fossa and clitoral sinuses, with one set of specimens including a specimen from the surfaces of the distal cervix or endometrium, of any female horses and from the surfaces of the prepuce, the urethral sinus, the distal urethra, and the fossa glandis, including the diverticulum of the fossa glandis, of any male horses. For both female and male horses, the sets of specimens must be collected on three separate occasions within a 12-day period with no less than 72 hours between each set, and the last of these sets of specimens must be collected within 30 days prior to exportation. All specimens required by this paragraph must be collected by a licensed veterinarian who either is, or is acting in the presence of, the veterinarian signing the certificate. Done in Washington, DC, this 21st day of March 2011. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2011-7098 Filed 3-24-11; 8:45 am]
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  • 9 CFR 93
  • 7 CFR 2.22
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