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Code · REGISTER · 2013-11-14 · Agency Health Agency for Healthcare Research and Quality NOTICES Meetings: Special Emphasis Panel, 68449 2013-27173 2013-27174 Senior Executive Service Performance Review Board Membership, 68450 2013- · Unknown

Unknown. Final rule

6,715 words·~31 min read·/register/2013/11/14/2013-27285

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-2013-11-14.xml --- 78 220 Thursday, November 14, 2013 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Meetings: Special Emphasis Panel, 68449 2013-27173 2013-27174 Senior Executive Service Performance Review Board Membership, 68450 2013-27169 Agriculture Agriculture Department See Animal and Plant Health Inspection Service See Grain Inspection, Packers and Stockyards Administration Animal Animal and Plant Health Inspection Service RULES Importations:
Ovine Meat from Uruguay, 68327-68331 2013-27285 Arts and Humanities, National Foundation See National Foundation on the Arts and the Humanities Consumer Financial Protection Bureau of Consumer Financial Protection RULES Homeownership Counseling Organizations Lists Interpretive Rule, 68343-68345 2013-27300 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68450-68452 2013-27274 2013-27275 Children Children and Families Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: ACF Program Instruction: Children's Justice Act, 68452-68453 2013-27221 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration See Patent and Trademark Office Commodity Futures Commodity Futures Trading Commission RULES Enhancing Protections Afforded Customers and Customer Funds Held by Futures Commission Merchants and Derivatives Clearing Organizations, 68506-68657 2013-26665 Consumer Product Consumer Product Safety Commission NOTICES Meetings;
Sunshine Act, 68424-68425 2013-27389 2013-27390 Defense Department Defense Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68425 2013-27250 Meetings: National Commission on the Structure of the Air Force, 68425-68427 2013-27270 Department of Transportation See Pipeline and Hazardous Materials Safety Administration Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Annual Performance Report and Certification of Financial Need for the Jacob K. Javits Fellowship Program, 68428-68429 2013-27268 Application for Approval to Participate in Federal Student Financial Aid Programs, 68427-68428 2013-27265 Jacob K. Javits Fellowship Program Final Performance Report, 68429-68430 2013-27269 Student Assistance General Provisions - Satisfactory Academic Progress Policy, 68427 2013-27267 Student Assistance General Provisions - Subpart E - Verification Student Aid Application Information, 68429 2013-27266 Energy Department Energy Department See Federal Energy Regulatory Commission RULES Energy Conservation Programs:
Exclusion of 100 Watt R20 Short Incandescent Reflector Lamp from Energy Conservation Standards, 68331-68343 2013-27248 NOTICES Meetings: Environmental Management Site-Specific Advisory Board, Hanford, 68431 2013-27241 Unconventional Resources Technology Advisory Committee, 68430 2013-27255 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Ohio; Ohio NOX SIP Call Rule Revisions, 68367-68370 2013-27142 Virginia;
Removal of the Regulation for the National Low Emission Vehicle Program, 68365-68367 2013-27029 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Ohio; Ohio NOX SIP Call Rule Revisions, 68377 2013-27144 Virginia; Removal of the Regulation for the National Low Emission Vehicle Program, 68377-68378 2013-27028 Approval and Promulgation of Air Quality Implementation Plans: Illinois; Amendments to Vehicle Inspection and Maintenance Program, 68378-68384 2013-27276 NOTICES Applicability Determinations, Alternative Monitoring Decisions, and Regulatory Interpretations:
Standards of Performance for New Stationary Sources, etc., 68432-68439 2013-27287 Meetings: FIFRA Scientific Advisory Panel; Rescheduled, 68439-68440 2013-27263 Executive Office of the President See Presidential Documents Export Import Export-Import Bank NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Report of Premiums Payable for Exporters Only, 68440 2013-27191 Report of Premiums Payable for Financial Institutions Only, 68440-68441 2013-27192 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives:
AERMACCHI S.p.A. Airplanes, 68357-68360 2013-26681 Airbus Airplanes, 68347-68355 2013-26564 2013-26565 DASSAULT AVIATION Airplanes, 68355-68357 2013-27071 Rolls-Royce plc Turbofan Engines, 68360 2013-27190 The Boeing Company Airplanes, 68345-68347 2013-27015 Unmanned Aircraft System Test Site Program, 68360-68364 2013-27216 Federal Communications Federal Communications Commission PROPOSED RULES National Television Multiple Ownership, 68384-68390 2013-26004 NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 68441 2013-27220 Meetings; Sunshine Act, 68442 2013-27369 Federal Deposit Federal Deposit Insurance Corporation NOTICES Updated Listing of Financial Institutions in Liquidation, 68442-68443 2013-27165 Federal Election Federal Election Commission NOTICES Filing Dates for the Florida Special Elections: 13th Congressional District, 68443-68444 2013-27187 Meetings; Sunshine Act, 68444 2013-27414 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 68462-68463 2013-27264 2013-27271 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 68431-68432 2013-27163 Initiations of Proceedings and Refund Effective Dates: Pacific Gas and Electric Co., 68432 2013-27164 Federal Maritime Federal Maritime Commission NOTICES Agreements Filed, 68444 2013-27253 Ocean Transportation Intermediary License Applicants, 68444-68445 2013-27254 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control:
Acquisitions of Shares of a Bank or Bank Holding Company, 68445 2013-27245 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 68445-68446 2013-27246 Federal Trade Federal Trade Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68446-68447 2013-27307 Federal Transit Federal Transit Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68501 2013-27249 Fish Fish and Wildlife Service RULES Endangered and Threatened Wildlife and Plants:
Technical Corrections for Kirtland's Warbler, 68370-68372 2013-27297 PROPOSED RULES Endangered and Threatened Wildlife and Plants: 12-Month Finding on a Petition to List the Gunnison's Prairie Dog as an Endangered or Threatened Species, 68660-68685 2013-27196 NOTICES Environmental Impact Statements; Availability, etc.: NiSource, Inc.; Record of Decision, Habitat Conservation Plan, Permit Issuance, 68465-68466 2013-27230 Food and Drug Food and Drug Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions, 68454-68455 2013-27226 Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients, etc., 68453-68454 2013-27222 Debarment Orders: Bruce I. Diamond; Denial of Hearing, 68455-68459 2013-27186 Draft Guidance for Industry and Staff; Availability: Medical Device Development Tools, 68459-68460 2013-27233 Draft Guidance for Industry;
Availability: Industry on Frequently Asked Questions About Medical Foods, 68460 2013-27213 Guidance for Industry; Availability: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds, 68461 2013-27194 Government Accountability Government Accountability Office NOTICES Standards for Internal Control in the Federal Government, 68447-68448 2013-27183 Grain Inspection Grain Inspection, Packers and Stockyards Administration NOTICES United States Standards for Whole Dry Peas, 68410-68411 2013-27131 Health and Human Health and Human Services Department See Agency for Healthcare Research and Quality See Centers for Disease Control and Prevention See Children and Families Administration See Food and Drug Administration See National Institutes of Health NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 68448-68449 2013-27244 Healthcare Research and Quality Agency See Agency for Healthcare Research and Quality Homeland Homeland Security Department See Federal Emergency Management Agency Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Record of Employee Interview, 68464 2013-27258 Regional Analysis of Impediments Guidance for Sustainable Communities Grantees, 68463-68464 2013-27256 Performance Review Board;
Appointments, 68464-68465 2013-27259 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See National Park Service See Ocean Energy Management Bureau See Surface Mining Reclamation and Enforcement Office International Trade Adm International Trade Administration NOTICES Antidumping Duty Administrative Reviews; Results, Extensions, Amendments, etc.: Freshwater Crawfish Tail Meat from the People's Republic of China, 68411-68412 2013-27312 Countervailing Duty Administrative Reviews;
Results, Extensions, Amendments, etc.: Non-Oriented Electrical Steel from the People's Republic of China, the Republic of Korea, and Taiwan, 68412-68416 2013-27316 International Trade Com International Trade Commission NOTICES Expedited Five-year Reviews; Results, Extensions, Amendments, etc.: Laminated Woven Sacks from China; Countervailing and Antidumping Duty Orders, 68473 2013-27211 Non-Malleable Cast Iron Pipe Fittings from China; Antidumping Duty Orders, 68474-68475 2013-27212 Sodium Nitrite from China and Germany;
Antidumping and Countervailing Duty Orders, 68474 2013-27210 Steel Nails from China; Antidumping Duty Order, 68472-68473 2013-27209 Investigations: Vision-Based Driver Assistance System Cameras and Components Thereof, 68475-68476 2013-27208 Meetings; Sunshine Act, 68476 2013-27361 Justice Department Justice Department NOTICES Proposed Consent Decrees under CERCLA, 68476-68477 2013-27197 Labor Department Labor Department See Occupational Safety and Health Administration Land Land Management Bureau NOTICES BLM Director's Response to the Idaho Governor's Appeal of the BLM Idaho State Director's Governor's Consistency Review Determination, 68466-68467 2013-27262 Meetings:
Twin Falls District Resource Advisory Council, Idaho, 68467 2013-27224 Records of Decisions: Transmission Line Project and Approved Land Use Plan Amendments in Idaho and Wyoming, 68467-68469 2013-27261 Legal Legal Services Corporation NOTICES Meetings; Sunshine Act, 68478-68479 2013-27425 NASA National Aeronautics and Space Administration PROPOSED RULES Removal of Procedures for Closeout of Grants and Cooperative Agreements, 68375-68376 2013-27234 Removal of Procedures for Delegation of Administration of Grants and Cooperative Agreements, 68376-68377 2013-27232 National Foundation National Foundation on the Arts and the Humanities NOTICES Meetings:
Federal Advisory Committee on International Exhibitions, 68479 2013-27251 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 68461-68462 2013-27170 2013-27172 National Institute of Mental Health, 68461-68462 2013-27171 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: 2013 Commercial Accountability Measure and Closure for South Atlantic Blue Runner, 68372-68373 2013-27242 2013 Commercial Accountability Measure and Closure for South Atlantic Gag, 68373 2013-27243 Fisheries of the Exclusive Economic Zone Off Alaska:
Yellowfin Sole for Vessels Participating in the BSAI Trawl Limited Access Fishery in the Bering Sea and Aleutian Islands Management Area, 68374 2013-27239 PROPOSED RULES Fisheries of the Exclusive Economic Zone Off Alaska: Bering Sea and Aleutian Islands Management Area; Amendment 102, 68390-68409 2013-26999 NOTICES Meetings: Marine Fisheries Advisory Committee, 68419 2013-27284 South Atlantic Fishery Management Council, 68416-68419 2013-27225 National Park National Park Service NOTICES Environmental Impact Statements;
Availability, etc.: Channel Islands National Park, Ventura and Santa Barbara Counties, CA; Draft General Management Plan / Wilderness Study, 68469-68470 2013-27283 National Register of Historic Places: Pending Nominations and Related Actions, 68470-68471 2013-27188 National Science National Science Foundation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68479-68480 2013-27257 Meetings: National Science Board, 68480 2013-27199 Meetings;
Sunshine Act, 68480 2013-27384 Occupational Safety Health Adm Occupational Safety and Health Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Overhead and Gantry Cranes, 68477-68478 2013-27237 Meetings: International Standards on the Transport of Dangerous Goods, 68501-68502 2013-27235 Ocean Energy Management Ocean Energy Management Bureau NOTICES Outer Continental Shelf: Alaska OCS Region, Chukchi Sea Planning Area, Proposed Oil and Gas Lease Sale 237, 68471 2013-27308 Patent Patent and Trademark Office NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Patent Trial and Appeal Board Actions, 68422-68424 2013-27215 Trademark Trial and Appeal Board Actions, 68419-68422 2013-27214 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Meetings: International Standards on the Transport of Dangerous Goods, 68501-68502 2013-27235 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: World Freedom Day (Proc. 9056), 68325-68326 2013-27377 Securities Securities and Exchange Commission NOTICES Self-Regulatory Organizations;
Proposed Rule Changes: Chicago Board Options Exchange, Inc., 68494-68496 2013-27202 Fixed Income Clearing Corp., 68496-68497 2013-27206 ICE Clear Credit LLC, 68480-68482 2013-27201 International Securities Exchange, LLC, 68497-68499 2013-27207 NASDAQ Stock Market LLC, 68482-68485, 68490-68494 2013-27203 2013-27204 NYSE MKT LLC, 68488-68490 2013-27240 Topaz Exchange, LLC, 68485-68487 2013-27205 State Department State Department NOTICES Designations as Foreign Terrorist Organizations:
Boko Haram, a.k.a. Nigerian Taliban, a.k.a. Jama'atu Ahlus-Sunnah Lidda'Awati Wal Jihad, 68500 2013-27296 Jama'atu Ansarul Muslimina Fi Biladis-Sudan, a.k.a. Ansaru, a.k.a. Ansarul Muslimina Fi Biladis Sudan, etc., 68499-68500 2013-27293 2013-27301 Specially Designated Global Terrorists: Boko Haram, a.k.a. Nigerian Taliban, a.k.a. Jama'atu Ahlus-Sunnah Lidda'Awati Wal Jihad, etc., 68500 2013-27295 Surface Mining Surface Mining Reclamation and Enforcement Office NOTICES Grants:
Abandoned Mine Land Reclamation Program; Intergovernmental Review, 68471-68472 2013-27228 Transportation Department Transportation Department See Federal Aviation Administration See Federal Transit Administration See Pipeline and Hazardous Materials Safety Administration U.S. China U.S.-China Economic and Security Review Commission NOTICES Meetings: Official Public Release of the Commission's 2013 Annual Report to Congress on November 20, 2013, 68502-68503 2013-27189 Veteran Affairs Veterans Affairs Department RULES Payment for Home Health Services and Hospice Care to Non-VA Providers, 68364 2013-27218 NOTICES Meetings:
Advisory Committee on Disability Compensation, 68503-68504 2013-27277 Advisory Committee on Minority Veterans, 68503 2013-27278 Separate Parts In This Issue Part II Commodity Futures Trading Commission, 68506-68657 2013-26665 Part III Interior Department, Fish and Wildlife Service, 68660-68685 2013-27196 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. 78 220 Thursday, November 14, 2013 Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 94 [Docket No.
APHIS-2008-0085] RIN 0579-AD17 Importation of Ovine Meat From Uruguay AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Final rule. SUMMARY: We are amending the regulations governing the importation of certain animals, meat, and other animal products to allow, under certain conditions, the importation of fresh (chilled or frozen) ovine meat from Uruguay. A risk assessment that we have prepared indicates that fresh (chilled or frozen) ovine meat can safely be imported from Uruguay under these conditions.
This action will allow the importation of fresh ovine meat from Uruguay into the United States while continuing to protect the United States against the introduction of foot-and-mouth disease. DATES: *Effective Date:* November 29, 2013. FOR FURTHER INFORMATION CONTACT: Dr. Silvia Kreindel, Senior Staff Veterinarian, Regionalization Evaluation Services Staff, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231;
(301)851-3313. SUPPLEMENTARY INFORMATION: Background Under the Animal Health Protection Act (AHPA, 7 U.S.C. 8301 *et seq.* ), the Secretary of Agriculture may prohibit or restrict the importation of any animal or article if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into or dissemination within the United States of any pest or disease of livestock. Pursuant to this Act, the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture
(USDA)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 part 94 (referred to below as the regulations) prohibit or restrict the importation of specified animals and animal products to prevent the introduction into the United States of various animal diseases, including rinderpest and foot-and-mouth disease (FMD). These are dangerous and destructive communicable diseases of ruminants and swine. Section 94.1 of the regulations contains criteria for APHIS recognition of foreign regions as free of rinderpest and FMD. Section 94.11 restricts the importation of ruminants and swine and their meat and certain other products from regions that are declared free of rinderpest and FMD but that nonetheless present a disease risk because of the regions' proximity to or trading relationships with regions affected with rinderpest or FMD. Regions APHIS has declared free of FMD and/or rinderpest, and regions declared free of FMD and rinderpest that are subject to the restrictions in § 94.11, are listed on the APHIS Web site at *http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml.* Because vaccination for FMD may not provide complete protection to livestock, and because it can be difficult to quickly detect FMD in animals vaccinated for FMD, APHIS does not recognize regions that vaccinate animals for FMD as free of the disease. Uruguay vaccinates cattle for FMD. Therefore, although Uruguay has not had a case of FMD since 2001, APHIS does not recognize Uruguay as a region free of FMD. Based on a final rule effective and published in the **Federal Register** on May 29, 2003 (68 FR 31940-31949, Docket No. 02-109-3), however, APHIS allows the importation of fresh (chilled or frozen) beef from Uruguay under certain conditions that mitigate the FMD risks associated with this product. The conditions are set out in § 94.22 of the regulations. In a proposed rule 1 published in the **Federal Register** on February 24, 2011 (76 FR 10266-10269, Docket No. APHIS-2008-0085), we proposed to also allow the importation of fresh ovine (sheep) meat from Uruguay under conditions identical to those currently required for the importation of fresh beef, except for one change noted below. The proposed conditions were as follows: 1 To view the proposed rule and the comments we received, go to *http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0085.* • The meat is from animals that have been born, raised, and slaughtered in Uruguay. • If FMD is detected anywhere in Uruguay, the export of beef and ovine meat from all of Uruguay to the United States is prohibited until at least 12 months have elapsed since the depopulation, cleaning, and disinfection of the last infected premises. [The current requirement for fresh beef is that FMD has not been diagnosed in Uruguay within the previous 12 months.] • The meat came from animals that originated from premises where FMD has not been present during the lifetime of any animals slaughtered for the export of meat to the United States. • The meat came from animals that were moved directly from the premises of origin to the slaughtering establishment without any contact with other animals. • The meat came from animals that received ante-mortem and post-mortem veterinary inspections, paying particular attention to the head and feet, at the slaughtering establishment, with no evidence found of vesicular disease. • The meat consists only of parts of the animal's carcass that are, by standard practice, placed in a chiller for maturation after slaughter. No part of the animal's heads, feet, hooves, or internal organs may be exported (and for bovines, the hump is also excluded). • All bone and visually identifiable blood clots and lymphoid tissue have been removed from the meat. • The meat has not been in contact with meat from regions other than those APHIS recognizes as free of FMD. • The meat came from carcasses that were allowed to maturate at 40 to 50 °F (4 to 10 °C) for a minimum of 36 hours after slaughter and that reached a pH of 5.8 or less in the loin muscle at the end of the maturation period. Measurements for pH must be taken at the middle of both *longissimus dorsi* muscles. Any carcass in which the pH does not reach 5.8 or less may be allowed to maturate an additional 24 hours and be retested, and, if the carcass still has not reached a pH of 5.8 or less after 60 hours, the meat from the carcass may not be exported to the United States. • An authorized veterinary official of the Government of Uruguay certifies on the foreign meat inspection certificate that the above conditions have been met. • The establishment in which the animals are slaughtered allows periodic on-site evaluation and subsequent inspection of its facilities, records, and operations by an APHIS representative. We solicited comments concerning the proposed rule for 60 days ending April 25, 2011. We received 10 comments by that date. They were from organizations representing Uruguayan meat packers, meat exporters, and sheep producers; Uruguay's Ministry of Livestock, Agriculture, and Fisheries (MGAP); organizations representing meat importers within the United States and the U.S. sheep industry; and several private citizens. Four of the commenters supported the rule as written. Two commenters objected to the proposal. The remaining commenters favored the importation of fresh (chilled or frozen) ovine meat from Uruguay but requested clarifications or modifications to the rule or its supporting documents. The issues raised by commenters are discussed below, by topic. The Risk Assessment One commenter requested that we reexamine our risk assessment that we prepared regarding the importation of fresh (chilled or frozen) ovine meat from Uruguay. The same commenter and one other requested that we conduct an additional site visit. They expressed concern that changes may have occurred in Uruguay's risk factors for FMD and in Uruguay's ability to prevent and mitigate FMD risk since we completed the risk assessment. Neither commenter mentioned any specific changes that should be investigated. One commenter also urged APHIS to specify a schedule requiring follow-up and ongoing reporting from Uruguay on FMD risk and the implementation of risk mitigation measures. We have reevaluated the information in the assessment and have determined that it still provides an appropriate basis for our conclusion that the FMD risk from importing fresh (chilled or frozen) maturated and deboned ovine meat from Uruguay is low and that such meat may be safely imported into the United States. Based on our review of the assessment, we do not think an additional site visit is warranted prior to finalizing the proposed rule. Regarding the need for ongoing reporting from Uruguay, as part of the implementation of this final rule, we will require MGAP to submit an operational workplan, subject to APHIS' approval, that details activities that MGAP will carry out to meet the requirements of the regulations. Additionally, paragraph
(k)of § 94.22 requires the establishment in Uruguay in which the bovines and sheep are slaughtered to allow an APHIS representative to make periodic on-site evaluations and subsequent inspections of its facilities, records, and operations. MGAP's operational workplan will have to specifically authorize the on-site evaluations and inspections of facilities, records, and operations. APHIS regulations in 9 CFR part 92 also address the potential need for APHIS to obtain additional information from a region after APHIS has granted the region animal health status. In particular, under § 92.2(g), a region may be required to submit additional information pertaining to animal health status or allow APHIS to conduct additional information collection activities in order for that region to maintain its animal health status. We believe these provisions, collectively, will enable APHIS to satisfactorily monitor the fresh meat import program. Prohibitions on the Importation of Meat Following an FMD Outbreak One commenter stated that the proposed prohibition on the export of fresh beef or ovine meat to the United States until 12 months after depopulation, cleaning, and disinfection of the last premises involved in an FMD outbreak does not merely clarify existing policy, as APHIS stated in its proposed rule. Rather, since the current requirement for fresh beef from Uruguay is 12 months following the last diagnosis of FMD, the proposed change would impose new, more stringent requirements for the importation of beef from Uruguay. The commenter also stated that, to be consistent with standards of the World Organization for Animal Health
(OIE)and the principle of regionalization, the prohibition on exports should be limited to 6 months and apply only to exports from restricted zones for FMD that would be established by MGAP in response to a limited outbreak in Uruguay, rather than to exports from anywhere in the country. FMD is a significant disease of livestock, and its introduction into the United States could have a lasting deleterious effect on the U.S. agricultural economy. In regions that vaccinate animals for FMD, it can be difficult to detect the disease, and APHIS believes that sufficient time must pass to ensure that ruminant products exported from the region will not be a vector of the FMD virus. Depopulation, cleaning, and disinfection of infected premises are standard practices in stamping out FMD. After considering this comment, though, we have decided that there is no need to build this language into the rule. If a country experiences an outbreak of FMD and there is no diagnosis of the disease in a 12-month period following the last case, APHIS considers this to be sufficient reason to conclude that the disease did not spread. Therefore, we will leave the provision as it is currently worded in the provisions for fresh beef: Foot-and-mouth disease has not been diagnosed in Uruguay within the previous 12 months. Consistent with the OIE principle of regionalization, APHIS regulations in 9 CFR part 92 explain how a country may request APHIS recognition of regions within its borders. In requesting to export fresh (chilled or frozen) ovine meat to the United States, Uruguay did not ask APHIS to recognize restricted zones as regions in the event of an FMD outbreak, or provide sufficient information for us to evaluate the risk of disease spread from such zones in order to allow for regionalization at that level. The Maturation Process One commenter questioned the need for a minimum 36-hour maturation period. Noting that the key indicator for ensuring deactivation of the FMD virus is a pH of 6.0 or lower, the commenter stated that if a pH of 5.8 is reached within 24 hours, then the virus will be deactivated and there is no need for an additional holding period. The commenter stated that the 36-hour holding period creates logistical problems for the packinghouses, which must hold carcasses in chillers, and is inconsistent with the requirements of other countries that apply a pH requirement of either 5.8 or 6.0, with a required holding period of 24 hours, for the export of Uruguayan meat to their markets. The commenter urged to require a minimum holding period of 24 hours. We agree with the commenter that the acidification necessary to inactivate the FMD virus can be achieved within 24 hours and are modifying § 94.22(i) in this final rule accordingly. Twenty-four hours will be the minimum time required for maturation. If the required pH is not achieved during 24 hours, the meat may continue to maturate for up to an additional 24 hours (48 hours total). Any meat that has not achieved the required pH level in that amount of time may not be exported to the United States. We have also determined that a pH lower than 6.0 in the longissimus dorsi, in conjunction with other conditions included in this final rule, is a good indicator of FMD virus inactivation. Our review of the literature revealed that acidification at that level is sufficient to inactivate FMD virus in muscle tissue of viremic cattle. Furthermore, over 30 years of epidemiological data show that there is no evidence that importation of fresh beef that reached a pH of less than 6.0 under conditions that are already incorporated into the regulations and that are analogous to those contained in this final rule (e.g., antemortem and postmortem inspection, lymph node removal, deboning, and maturation) have been associated with outbreaks of FMD. Therefore, in § 94.22(i) of this final rule, the meat will be required to reach a pH of less than 6.0, rather than 5.8 or less, as we had originally proposed. Removal of Bones One commenter stated that there is no basis for limiting approval for export of ovine meat to boneless products because there has been no evidence of FMD in sheep in Uruguay since the country requested access for fresh beef exports in 2003. We proposed to require that all bone, as well as visually identifiable blood clots and lymphoid tissue, be removed from fresh ovine meat prior to export to the United States from Uruguay. The same requirement has been in place for fresh beef exported from Uruguay. As we noted in both our risk assessment and in the proposed rule, although the last case of FMD in Uruguay was in 2001, FMD is endemic in areas of South America surrounding Uruguay, and there is, accordingly, a risk that FMD will be reintroduced into the country. Uruguay vaccinates cattle for FMD in recognition of that risk. Each of the conditions we proposed, including this one, addresses a critical point in the pre-export process, from selection of an animal for slaughter to carcass processing and maturation, where FMD risk can be mitigated. The conditions were selected based on known modes of transmission and physical characteristics of the FMD virus. Maturation of the meat addresses the risk, however small, of FMD virus being present in the animal at slaughter. The removal of bones and visually identifiable blood clots and lymphoid tissue is necessary because any FMD virus these parts might potentially harbor may not be inactivated by the maturation process. Certification by Veterinary Officials in Uruguay One commenter expressed concern about our proposed requirement that an authorized veterinary official of the Government of Uruguay certify that all conditions for the importation of beef and ovine meat have been met. The commenter stated that veterinary officials could be bribed or otherwise induced to falsely certify meat as meeting the conditions for importation, which could pose a risk of introducing FMD into the United States. As explained in response to another comment, APHIS will be monitoring the fresh meat export program. If we determine that inspection certificates are being deliberately falsified, we may take measures pursuant to our authority under the AHPA to ensure that beef or ovine meat from Uruguay does not present a risk of introducing FMD into the United States. Such measures may include prohibiting the importation of fresh beef and ovine meat from Uruguay. Labeling of Ovine Meat One commenter asked whether ovine meat imported as proposed would be labeled and marketed in the United States as “fresh.” The commenter stated that, because the product would have been chilled or frozen, it would not meet the average U.S. consumer's definition of “fresh” and should not be marketed as such. The commenter also asked whether ovine meat imported from Uruguay into the United States would be subject to country-of-origin labeling. As used in the regulations, the term “fresh” simply means that the meat is imported without having been cooked or cured as otherwise required of beef or ovine meat from regions not recognized as free of FMD. APHIS does not regulate the marketing of meat in the United States. Regarding country-of-origin labeling, the Country of Origin Labeling
(COOL)law requires retailers to notify their customers of the country of origin for all commodities covered under this law. Muscle cuts of beef and lamb, as well as ground beef and ground lamb, are covered. The COOL law is enforced by USDA's Agricultural Marketing Service and Food Safety and Inspection Service. The COOL law is not related to animal health, but rather, is a consumer information program, and thus has no bearing on this rulemaking. Goat Meat One commenter expressed concern that inspectors may not know the difference between a goat kid carcass and a lamb kid carcass. Establishments in Uruguay that prepare ovine meat for export slaughter the sheep. Live sheep are easily distinguishable from live goats. It is unlikely that a facility would slaughter a goat and present its meat as ovine meat. As discussed previously, APHIS will be monitoring the fresh meat export program, including through on-site evaluations and inspections of facilities, records, and operations. Chronic Wasting Disease One commenter objected to the lack of inspection for chronic wasting disease. Chronic wasting disease
(CWD)is a transmissible spongiform encephalopathy of cervids (members of Cervidae, the deer family). Species known to be susceptible to CWD via natural routes of transmission include Rocky Mountain elk, mule deer, white-tailed deer, black-tailed deer, and moose. There is no evidence that CWD is transmissible under natural conditions to any other ruminant species, including cattle and sheep, and, therefore, no need for any CWD-related safeguards. Miscellaneous We have made minor editorial changes to the regulatory text in § 94.22 for clarity. These include replacing “and” with “or” in the following phrases: “beef and ovine meat,” “bovines and sheep,” and “bovine parts and ovine parts,” and changing “infected premises” to “affected premises.” 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. Effective Date This is a substantive rule that relieves restrictions and, pursuant to the provisions of 5 U.S.C. 553, may be made effective less than 30 days after publication in the **Federal Register** . This rule will allow the importation of fresh ovine meat from Uruguay into the United States under conditions that will continue to protect the United States against the introduction of FMD. We have determined that approximately 2 weeks are needed to ensure that APHIS and Department of Homeland Security, Bureau of Customs and Border Protection, personnel at ports of entry receive official notice of this change in the regulations. Therefore, the Administrator of the Animal and Plant Health Inspection Service has determined that this rule should be effective 15 days after publication in the **Federal Register** . Executive Order 12866 and the Regulatory Flexibility Act This final 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. In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available on the Regulations.gov Web site (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT . This rule will allow the importation of fresh (chilled or frozen) lamb and mutton from Uruguay under certain conditions. U.S. entities potentially affected by the rule would be sheep farmers and establishments primarily engaged in processing meat and meat products from purchased meat, most of which are small entities under Small Business Administration standards. U.S. production of lamb and mutton averaged 79,561 metric tons
(MT)over the 5 years, 2006-2010. Over this same period, imports averaged almost 75,100 MT (equivalent to about 94 percent of U.S. production). Uruguay expects its annual lamb and mutton exports to the United States not to exceed 2,000 MT. This quantity is equivalent to less than 3 percent of U.S. lamb and mutton imports and less than 2 percent of U.S. domestic supply of these commodities. A percentage of the imports from Uruguay are likely to displace some of the lamb and mutton imported from existing foreign suppliers, further dampening any possible effects for U.S. businesses. Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities. 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. National Environmental Policy Act An environmental assessment and finding of no significant impact have been prepared for this final rule. The environmental assessment provides a basis for the conclusion that the importation of ovine meat from Uruguay under the conditions specified in the rule will not have a significant impact on the quality of the human environment. Based on the finding of no significant impact, the Administrator of the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared. The environmental assessment and finding of no significant impact were prepared in accordance with:
(1)The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 *et seq.* ),
(2)regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508),
(3)USDA regulations implementing NEPA (7 CFR part 1b), and
(4)APHIS' NEPA Implementing Procedures (7 CFR part 372). The environmental assessment and finding of no significant impact may be viewed on the Regulations.gov Web site. 2 Copies of the environmental assessment and finding of no significant impact are also available for public inspection at USDA, room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons wishing to inspect copies are requested to call ahead on
(202)799-7039 to facilitate entry into the reading room. In addition, copies may be obtained by writing to the individual listed under FOR FURTHER INFORMATION CONTACT . 2 Go to *http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0085.* The environmental assessment and finding of no significant impact will appear in the resulting list of documents. Paperwork Reduction Act In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ), the information collection or recordkeeping requirements included in this rule have been approved by the Office of Management and Budget
(OMB)under OMB control number 0579-0372. E-Government Act Compliance The Animal and Plant Health Inspection Service is committed to compliance 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. For information pertinent to E-Government Act compliance related to this rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at
(301)851-2908. List of Subjects in 9 CFR Part 94 Animal diseases, Imports, Livestock, Meat and meat products, Milk, Poultry and poultry products, Reporting and recordkeeping requirements. Accordingly, we are amending 9 CFR part 94 as follows: PART 94—RINDERPEST, FOOT-AND-MOUTH DISEASE, NEWCASTLE DISEASE, HIGHLY PATHOGENIC AVIAN INFLUENZA, AFRICAN SWINE FEVER, CLASSICAL SWINE FEVER, SWINE VESICULAR DISEASE, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND RESTRICTED IMPORTATIONS 1. 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. 2. Section 94.1 is amended by revising paragraph (b)(4) and the introductory text of paragraph
(d)to read as follows: § 94.1 Regions where rinderpest or foot-and-mouth disease exists; importations prohibited.
(b)* * *
(4)Except as provided in § 94.22 for fresh (chilled or frozen) beef and ovine meat from Uruguay.
(d)Except as otherwise provided in this part, fresh (chilled or frozen) meat of ruminants or swine raised and slaughtered in a region free of foot-and-mouth disease and rinderpest, as designated in paragraph
(a)of this section, and fresh (chilled or frozen) beef and ovine meat exported from Uruguay in accordance with § 94.22, which during shipment to the United States enters a port or otherwise transits a region where rinderpest or foot-and-mouth disease exists, may be imported provided that all of the following conditions are met: 3. Section 94.22 is revised to read as follows: § 94.22 Restrictions on importation of beef and ovine meat from Uruguay. Notwithstanding any other provisions of this part, fresh (chilled or frozen) beef and ovine meat from Uruguay may be exported to the United States under the following conditions:
(a)The meat is beef or ovine meat from animals that have been born, raised, and slaughtered in Uruguay.
(b)Foot-and-mouth disease has not been diagnosed in Uruguay within the previous 12 months.
(c)The meat comes from bovines or sheep that originate from premises where foot-and-mouth disease has not been present during the lifetime of any bovines and sheep slaughtered for the export of beef and ovine meat to the United States.
(d)The meat comes from bovines or sheep that were moved directly from the premises of origin to the slaughtering establishment without any contact with other animals.
(e)The meat comes from bovines or sheep that received ante-mortem and post-mortem veterinary inspections, paying particular attention to the head and feet, at the slaughtering establishment, with no evidence found of vesicular disease.
(f)The meat consists only of bovine parts or ovine parts that are, by standard practice, part of the animal's carcass that is placed in a chiller for maturation after slaughter. The bovine and ovine parts that may not be imported include all parts of the head, feet, hump, hooves, and internal organs.
(g)All bone and visually identifiable blood clots and lymphoid tissue have been removed from the meat.
(h)The meat has not been in contact with meat from regions other than those listed as free of foot-and-mouth disease and rinderpest under § 94.1(a).
(i)The meat comes from carcasses that were allowed to maturate at 40 to 50 °F (4 to 10 °C) for a minimum of 24 hours after slaughter and that reached a pH below 6.0 in the loin muscle at the end of the maturation period. Measurements for pH must be taken at the middle of both *longissimus dorsi* muscles. Any carcass in which the pH does not reach less than 6.0 may be allowed to maturate an additional 24 hours and be retested, and, if the carcass still has not reached a pH of less than 6.0 after 48 hours, the meat from the carcass may not be exported to the United States.
(j)An authorized veterinary official of the Government of Uruguay certifies on the foreign meat inspection certificate that the above conditions have been met.
(k)The establishment in which the bovines and sheep are slaughtered allows periodic on-site evaluation and subsequent inspection of its facilities, records, and operations by an APHIS representative. (Approved by the Office of Management and Budget under control number 0579-0372) Done in Washington, DC, this 7th day of November 2013. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2013-27285 Filed 11-13-13; 8:45 am]
Connectionstraces to 9
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  • 9 CFR 94
  • 9 CFR 92
  • 7 CFR 1
  • 7 CFR 372
  • 7 CFR 2.22
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