Unknown. Final rule

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--- schema: federal-register doc_type: fedreg source_file: FR-2010-11-15.xml --- 75 219 Monday, November 15, 2010 Contents Agency Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 69674-69679 2010-28367 2010-28368 Agriculture Agriculture Department See Food Safety and Inspection Service See Forest Service Antitrust Antitrust Division NOTICES National Cooperative Research and Production Act of 1993:

Marine Well Containment Venture, 69705 2010-28558 Army Army Department NOTICES Privacy Act; Systems of Records, 69650-69652 2010-28750 2010-28751 Blind or Severely Disabled, Committee for Purchase From People Who Are See Committee for Purchase From People Who Are Blind or Severely Disabled Broadcasting Broadcasting Board of Governors NOTICES Meetings; Sunshine Act, 69620 2010-28782 Centers Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 69673-69674 2010-28577 Meetings: Board of Scientific Counselors, Office of Infectious Diseases, 69687 2010-28581 Disease, Disability, and Injury Prevention and Control Special Emphasis Panel, 69686-69687 2010-28597 Centers Centers for Medicare & Medicaid Services RULES Medicaid Program: Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, etc., 69591-69597 2010-28649 NOTICES Medicare and Medicaid Programs:

Approval of Det Norske Veritas Healthcare for Deeming Authority for Critical Access Hospitals, 69682-69685 2010-28666 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Income Withholding for Support, 69682 2010-28615 Commerce Commerce Department See Foreign-Trade Zones Board See Industry and Security Bureau See International Trade Administration See National Oceanic and Atmospheric Administration See Patent and Trademark Office NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 69621 2010-28616 2010-28619 Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List; Additions and Deletions, 69638-69640 2010-28623 2010-28624 Consumer Consumer Product Safety Commission NOTICES Meetings; Sunshine Act, 69640 2010-28785 2010-28789 Defense Defense Department See Army Department See Navy Department NOTICES Meetings: Advisory Council on Dependents' Education, 69640-69641 2010-28643 Military Leadership Diversity Commission, 69641 2010-28641 Performance Review Board Membership, 69642 2010-28642 Privacy Act;

Systems of Records, 69642-69647 2010-28752 2010-28754 2010-28755 Renewal of Department of Defense Federal Advisory Committees, 69647-69648 2010-28753 Defense Defense Nuclear Facilities Safety Board NOTICES Safety Analysis Requirements for Defining Adequate Protection for the Public and the Workers, 69648-69649 2010-28683 Drug Drug Enforcement Administration NOTICES Importer of Controlled Substances; Applications: Chattem Chemicals Inc., Chattanooga, TN, 69705 2010-28532 Energy Energy Department See Energy Efficiency and Renewable Energy Office NOTICES Meetings:

National Commission on the BP Deepwater Horizon Oil Spill and Offshore Drilling, 69652-69653 2010-28645 Energy Energy Efficiency and Renewable Energy Office NOTICES Energy Conservation Program for Consumer Products, Waivers: Whirlpool Corp. from the Residential Clothes Washer Test Procedure, 69653-69655 2010-28646 Meetings: Energy Efficiency and Renewable Energy Advisory Committee, 69655-69656 2010-28640 EPA Environmental Protection Agency RULES Approval and Promulgation of Air Quality Implementation Plans:

New York, New Jersey, and Connecticut; Determination of Attainment of the 1997 Fine Particle Standard, 69589-69591 2010-28504 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Experimental Use Permits for Pesticides, 69658-69659 2010-28654 Pesticide Registration Fees Program, 69659-69660 2010-28662 Request for Contractor Access to TSCA Confidential Business Information, 69656-69657 2010-28656 Requirements for Certified Applicators Using 1080 Collars for Livestock Protection, 69657-69658 2010-28657 Cross-Media Electronic Reporting Rule State Authorized Program Revision Approval;

Hawaii, 69660-69661 2010-28651 Nominations to the Environmental Financial Advisory Board, 69661-69662 2010-28664 Public Water System Supervision Program Revision for the State of Colorado, 69662 2010-28497 Workshops: Cumulative Mixtures Risk of Six Selected Phthalates, 69662-69664 2010-28665 Executive Office of the President See Presidential Documents FAA Federal Aviation Administration RULES Aging Airplane Program: Widespread Fatigue Damage, 69746-69789 2010-28363 PROPOSED RULES Airworthiness Directives:

Boeing Co. Model 747-200B, -300, -400, -400D, and -400F Series Airplanes Powered by Pratt and Whitney 4000 or General Electric CF6 80C2 Series Engines, 69612-69614 2010-28605 Bombardier, Inc. Model CL 600 2B19 (Regional Jet Series 100 & 440) Airplanes, 69609-69611 2010-28604 Fokker Services B.V. Model F.28 Mark 0070 and 0100 Airplanes, 69606-69609 2010-28606 Rolls-Royce plc RB211-Trent 768, 772, and 772B Turbofan Engines, 69611-69612 2010-28583 FDIC Federal Deposit Insurance Corporation RULES Deposit Insurance Regulations:

Unlimited Coverage for Noninterest-Bearing Transaction Accounts, 69577-69583 2010-28627 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 69664 2010-28626 Updated Listing of Financial Institutions in Liquidation, 69664-69665 2010-28628 Federal Motor Federal Motor Carrier Safety Administration NOTICES Qualification of Drivers; Exemption Applications; Diabetes Mellitus, 69734-69737 2010-28695 Qualification of Drivers; Exemption Applications;

Vision, 69737-69739 2010-28699 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 69665 2010-28568 Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company, 69666 2010-28622 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 69666 2010-28621 FTC Federal Trade Commission NOTICES Granting of Request for Early Termination of Waiting Period Under Premerger Notification Rules, 69666-69671 2010-28369 Fish Fish and Wildlife Service NOTICES Endangered Species Recovery Permit Applications, 69699-69700 2010-28593 Permit Applications:

Endangered Species, 69701-69702 2010-28582 Permits: Endangered Species; Marine Mammals, 69703 2010-28580 Food Food and Drug Administration RULES New Animal Drugs for Minor Use and Minor Species, 69586-69588 2010-28550 New Animal Drugs; Change of Sponsor: Sulfadiazine and Pyrimethamine Suspension, 69585-69586 2010-28549 PROPOSED RULES New Animal Drugs for Minor Use and Minor Species, 69614-69616 2010-28551 Food Food Safety and Inspection Service RULES Permission to Use Air Inflation of Meat Carcasses and Parts, 69575-69577 2010-28650 Foreign Foreign Assets Control Office NOTICES Designation of Three Individuals and One Entity Pursuant to Executive Order 13224, 69742 2010-28595 Foreign Foreign-Trade Zones Board NOTICES Applications for Reorganization/Expansion under Alternative Site Framework:

Foreign-Trade Zone 50, Long Beach, CA, 69621-69622 2010-28675 Forest Forest Service NOTICES Environmental Impact Statements; Availability, etc.: East Reservoir Project, Kootenai National Forest; Lincoln County, MT, 69619 2010-28614 Meetings: Chippewa National Forest Resource Advisory Committee, 69619-69620 2010-28601 Humboldt Resource Advisory Committee, 69620 2010-28598 Lincoln County Resource Advisory Committee, 69620 2010-28611 Health 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 Health Resources and Services Administration See National Institutes of Health See Substance Abuse and Mental Health Services Administration Health Health Resources and Services Administration NOTICES Meetings:

Advisory Committee on Training in Primary Care Medicine and Dentistry; Cancellation, 69686 2010-28693 Homeland Homeland Security Department See U.S. Customs and Border Protection PROPOSED RULES Privacy Act; Implementation of Exemptions: National Infrastructure Coordinating Center Records System of Records, 69603-69604 2010-28569 Operations Collection, Planning, Coordination, Reporting, Analysis, and Fusion System of Records, 69604-69606 2010-28572 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 69688 2010-28575 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Regulation on Agency Protests, 69688-69689 2010-28574 Privacy Act; Systems of Records, 69689-69697 2010-28566 2010-28588 Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Home Energy Retrofit Loan Pilot Program, 69697-69698 2010-28713 Industry Industry and Security Bureau NOTICES Impact of Implementation of the Chemical Weapons Convention on Commercial Activities, etc., 69630-69631 2010-28689 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See National Park Service See Reclamation Bureau NOTICES Meetings:

Invasive Species Advisory Committee, 69698 2010-28653 IRS Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2010-28576 69739-69741 2010-28585 2010-28586 International International Trade Administration NOTICES Final Determination of Sales at Less than Fair Value and Antidumping Duty Orders: Certain Steel Grating from the People's Republic of China; Correction, 69626 C1--2010--28688 Final Results of Antidumping Duty Administrative Reviews:

Certain Welded Carbon Steel Standard Pipes and Tubes from India, 69626-69628 2010-28685 Final Results of Sunset Review and Revocation of Orders: Non-Frozen Apple Juice Concentrate from the People's Republic of China, 69628-69629 2010-28678 Final Results of the Antidumping Duty Administrative Reviews: Polyethylene Terephthalate Film, Sheet, and Strip from the People's Republic of China, 69629-69630 2010-28674 International International Trade Commission NOTICES Complaints: Certain Turbomachinery Blades, Engines, and Components Thereof, 69703-69704 2010-28625 Justice Justice Department See Antitrust Division See Drug Enforcement Administration NOTICES Lodging Of Second Proposed Amendment To Consent Decree Under The Clean Water Act:

United States and State of Indiana v. City of Indianapolis, 69704-69705 2010-28599 Labor Labor Department See Mine Safety and Health Administration Land Land Management Bureau NOTICES Meetings: John Day/Snake Resource Advisory Council, 69701 2010-28602 Mine Mine Safety and Health Administration PROPOSED RULES Lowering Miners Exposure to Respirable Coal Mine Dust, Including Continuous Personal Dust Monitors, 69617-69618 2010-28676 National Credit National Credit Union Administration NOTICES Meetings;

Sunshine Act, 2010-28795 69705-69706 2010-28808 NIH National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: California Health Interview Survey Cancer Control Module, 69681-69682 2010-28648 The National Childrens Study, 69680-69681 2010-28701 Meetings: National Institute of Diabetes and Digestive and Kidney Diseases, 69685-69686 2010-28706 Office of the Director, National Institutes of Health, 69686 2010-28704 Proposed Actions Under NIH Guidelines for Research Involving Recombinant DNA Molecules, 69687-69688 2010-28698 NOAA National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska:

Pacific Cod in the Bering Sea and Aleutian Islands Management Area, 69597-69598 2010-28672 Pacific Ocean Perch by Vessels in the Amendment 80 Limited Access Fishery in the Eastern Aleutian District; Closure, 69599 2010-28679 Pacific Ocean Perch by Vessels in the Amendment 80 Limited Access Fishery in the Western Aleutian District; Closure, 69599-69600 2010-28681 Pacific Ocean Perch by Vessels in the Amendment 80 Limited Access Fishery, etc.; Closure, 69598-69599 2010-28677 Pacific Ocean Perch in the Central Aleutian District of the Bering Sea, etc.;

Closure, 69601 2010-28687 Pacific Ocean Perch in the Eastern Aleutian District of the Bering Sea, etc.; Closure, 69600 2010-28684 Pacific Ocean Perch in the Western Aleutian District of the Bering Sea and Aleutian Islands Management Area; Closure, 69601-69602 2010-28694 NOTICES Draft Revision of the Estuary Habitat Restoration Strategy, 69622-69625 2010-28696 Meetings: North Pacific Fishery Management Council, 69632 2010-28610 Permits Marine Mammals; File No. 15206, 69633 2010-28697 Plan for Periodic Review of Regulations, 69633-69638 2010-28700 National Park National Park Service NOTICES Continuation of Concession Contract, 69699 2010-28702 Environmental Impact Statements;

Availability, etc.: Cape Hatteras National Seashore Off-Road Vehicle Management Plan, 69700-69701 2010-28710 Extension of Concession Contract, 69701 2010-28705 National Transportation National Transportation Safety Board NOTICES SES Performance Review Board, 69706 2010-28652 Navy Navy Department NOTICES Environmental Assessments; Availability: Small-Scale Wind Energy Projects; United States Marine Corps Facilities Throughout the United States, 69649-69650 2010-28613 Nuclear Nuclear Regulatory Commission NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 2010-28636 69706-69707 2010-28637 Amendments to Facility Operating License: Exelon Generation Company, LLC, 69707-69709 2010-28635 Availability of Final Staff Guidance: Standard Review Plan; Revision 0 on Cyber Security Plan, 69709-69710 2010-28634 Environmental Assessments; Availability, etc.: Crystal River Unit 3 Nuclear Generating Plant, Florida Power Corp., et al., 69710-69711 2010-28633 Exemptions: STP Nuclear Operating Co., South Texas Project Nuclear Power Plant, 69711-69715 2010-28638 Patent Patent and Trademark Office PROPOSED RULES Rules of Practice Before the Board of Patent Appeals and Interferences in Ex Parte Appeals, 69828-69849 2010-28493 NOTICES Meetings:

National Medal of Technology and Innovation Nomination Evaluation Committee, 69631-69632 2010-28802 Pension Pension Benefit Guaranty Corporation RULES Benefits Payable in Terminated Single-Employer Plans: Interest Assumptions for Paying Benefits, 69588-69589 2010-28570 Personnel Personnel Management Office NOTICES Privacy Act; Systems of Records, 69715 2010-28834 Postal Postal Regulatory Commission NOTICES New Postal Product, 69715-69716 2010-28584 Presidential Presidential Documents PROCLAMATIONS Special Observances:

World Freedom Day (Proc. 8599), 69571-69572 2010-28852 EXECUTIVE ORDERS Government Agencies and Employees: Export Enforcement Coordination Center; Establishment (EO 13558), 69573-69574 2010-28854 Railroad Railroad Retirement Board NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 69716-69717 2010-28600 Reclamation Reclamation Bureau NOTICES Central Valley Project Improvement Act: Criteria for Developing Refuge Water Management Plans, 69698-69699 2010-28603 SECURITIES AND EXCHANGE Securities and Exchange Commission RULES Risk Management Controls for Brokers or Dealers with Market Access, 69792-69826 2010-28303 NOTICES Orders of Suspension of Trading:

Edentify, Inc., et al., 69717 2010-28775 Self-Regulatory Organizations; Proposed Rule Changes: Financial Industry Regulatory Authority, Inc., 69725-69726 2010-28608 International Securities Exchange, LLC, 69726-69729 2010-28686 NASDAQ Stock Market LLC, 69717-69722 2010-28548 NYSE Amex LLC, 69722-69725 2010-28607 NYSE Arca, Inc., 69729-69730 2010-28690 Stock Clearing Corporation of Philadelphia, 69730-69732 2010-28663 SMALL Business Administration Small Business Administration NOTICES Disaster Declarations:

California, 69733 2010-28587 Puerto Rico; Amendment 1, 69733 2010-28673 South Dakota, 69732-69733 2010-28682 U.S. Virgin Islands, 69732 2010-28671 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2010-28668 69671-69673 2010-28669 2010-28670 Transportation Transportation Department See Federal Aviation Administration See Federal Motor Carrier Safety Administration NOTICES Applications for Certificate Authority:

National Air Cargo Group, Inc. d/b/a National Airlines, 69733-69734 2010-28620 Applications for Communter Air Carrier Authorization: Island Airlines, LLC, 69734 2010-28618 Treasury Treasury Department See Foreign Assets Control Office See Internal Revenue Service Customs U.S. Customs and Border Protection RULES Technical Corrections to Regulations, 69583-69585 2010-28709 Veterans Veterans Affairs Department NOTICES Enhanced-Use Leases: Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, WI, 69742-69743 2010-28632 Separate Parts In This Issue Part II Transportation Department, Federal Aviation Administration, 69746-69789 2010-28363 Part III Securities and Exchange Commission, 69792-69826 2010-28303 Part IV Commerce Department, Patent and Trademark Office, 69828-69849 2010-28493 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. 75 219 Monday, November 15, 2010 Rules and Regulations DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Part 310 [Docket No. FSIS-2007-0039] RIN 0583-AD33 Permission To Use Air Inflation of Meat Carcasses and Parts AGENCY:

Food Safety and Inspection Service, USDA. ACTION: Final rule. SUMMARY: The Food Safety and Inspection Service

(FSIS)is amending the Federal meat inspection regulations to provide that establishments that slaughter livestock or prepare livestock carcasses and parts may inflate carcasses and parts with air if they develop, implement, and maintain written controls to ensure that the procedure does not cause insanitary conditions or adulterate the product. FSIS is requiring establishments to incorporate these controls into their Hazard Analysis and Critical Control Point (HACCP) plans or Sanitation Standard Operating Procedures (Sanitation SOPs) or other prerequisite programs. In addition, FSIS is amending its regulations to remove the approved methods for inflating livestock carcasses and parts by air and to remove the requirement that establishments submit requests to FSIS for approval of air inflation procedures not listed in the regulations. FSIS is also adding a paragraph in the regulations to make clear that the current prohibition against injecting compressed air into the skulls of cattle remains in force. DATES: *Effective:* December 15, 2010. FOR ADDITIONAL INFORMATION: Contact Rachel Edelstein, Director, Policy Issuances Division, Office of Policy and Program Development, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250;

(202)720-5627. SUPPLEMENTARY INFORMATION: Background FSIS has been delegated the authority to exercise the functions of the Secretary of Agriculture as specified in the Federal Meat Inspection Act

(FMIA)(21 U.S.C. 601, *et seq.* ). Under this statute, FSIS protects the public by verifying that meat products are safe, wholesome, not adulterated, and properly labeled and packaged. On May 24, 2010, FSIS proposed to amend the Federal meat inspection regulations concerning air inflation. The proposed rule explained that on October 3, 1970, the Federal Meat Inspection regulations were revised to prohibit inflation with air of carcasses or parts of carcasses (35 FR 15568). On September 5, 1989, FSIS modified the prohibition in 9 CFR 310.13(a) by providing for the use of several air inflation procedures that had been field tested and that the Agency found to be acceptable (54 FR 36756). The regulations required that establishments interested in the use of air inflation procedures other than the approved methods submit to FSIS a request for experimental testing of the unapproved procedure. The regulations also provided that if FSIS were to find a new method to be acceptable, it would modify its regulations to include the new method. As FSIS stated in the proposed rule, the Agency's original intent in disallowing the use of air inflation was to prevent insanitary conditions from arising and to prevent the adulteration of carcasses or parts of carcasses. However, the Agency recognized in the 1989 final rule that air inflation procedures could be used in a sanitary manner without adulterating product and consequently approved the limited use of air inflation procedures. Under a waiver from FSIS, Packerland Co. (also known as JBS Packerland) used an air inflation methodology to separate the brisket and round portions from beef carcasses to increase the efficiency of its fabrication. In July 2007, Packerland Co. petitioned FSIS to amend its regulations to allow for this air inflation methodology. In support of its petition, Packerland Co. presented aerobic bacteria plate count data that showed that the use of Packerland's air inflation procedure did not cause insanitary conditions or adulterate product. Based on the Agency's accumulated experience with air inflation procedures and on its evaluation of Packerland's petition, FSIS decided to grant Packerland's petition and proposed to permit establishments that slaughter livestock carcasses and parts to inflate carcasses and parts with air if they develop, implement, and maintain written controls to ensure that the procedure does not cause insanitary conditions or adulterate product. FSIS proposed to require that establishments incorporate these controls into their HACCP plans or Sanitation SOPs or other prerequisite programs. FSIS also proposed to amend its regulations to remove the approved methods for inflating livestock carcasses and parts by air and to remove the requirement that establishments submit requests to FSIS for approval of air inflation procedures not listed in the regulations. Comments and FSIS Response The Agency received three comments on the proposal. One trade association supported the proposed rule and stated that the proposed action will enhance slaughter house safety programs, reduce repetitive motion injuries, and create economic benefits through better use of employees. In addition, the commenter stated that the proposal will facilitate adoption of new air inflation technology. A large corporation also supported the proposal. The commenter stated that air from air inflation procedures is present in the finished food at insignificant levels and does not have any technical or functional effect in that food after the use of those procedures. The commenter stated that, therefore, these procedures meet the definition of incidental additives as defined in 21 CFR 101.100(a)(3) and are exempt from labeling requirements. The question presented in this rulemaking is whether FSIS should provide for air inflation in its regulations. How products produced using air inflation technology need to be labeled is a separate question that FSIS did not address in the proposed rule. Such product would not be required to be labeled to indicate that it has been produced using air inflation. In addition, FSIS does not agree that air used to inflate carcasses and parts constitutes an incidental additive as defined in 21 CFR 101.100 (a)(3) because air is a gas mixture that is being used to separate muscle tissue, and there is no residual of any of the gases in the tissue after use. An individual commenter stated that a reference in the preamble to the proposed rule to the disallowance of air injection into the skull of cattle appears to be incorrect. The comment pointed out that the reference should be 9 CFR 310.13 (a)(2)(iv)(C), not 9 CFR 310.13(a)(2)(iv)(D). The Agency agrees that 9 CFR 310.13(a)(2)(iv)(C) is the correct citation. Therefore, nothing presented by the comments would cause the Agency to not adopt the proposed rule. The Final Rule FSIS is amending 9 CFR 310.13(a) to permit establishments that slaughter livestock or prepare livestock carcasses and parts to inflate carcasses or parts of carcasses with air if they develop, implement, and maintain controls to ensure that those procedures do not cause insanitary conditions or adulterate product. Under the new rule, all methods of air inflation will be permitted if establishments develop, implement, and maintain controls to ensure that these procedures do not cause insanitary conditions or adulterate product. Therefore, FSIS is also removing the approved methods for inflating meat carcasses and parts from the regulations. For the same reason, the Agency is removing the requirement that establishments submit requests to FSIS for approval of air inflation procedures not listed in the regulations. Under this final rule, establishments that are using an approved air inflation procedure can continue to do so, but they will be required to incorporate their air inflation procedures into their HACCP plans or Sanitation SOPs or other prerequisite programs. As part of their HACCP plans and hazard analysis, establishments are required to prepare a flow chart describing the steps of each process and product flow in the establishment (9 CFR 417.2(a)(2)). Under the final rule, if an establishment uses air inflation procedures, the flow chart will need to include those procedures. Under the HACCP regulations, establishments are also required to consider whether air inflation may make biological hazards, such as contamination with certain pathogens, reasonably likely to occur (9 CFR 417.2(a)(1)). Also under the HACCP regulations, if an establishment determines that air inflation procedures do not introduce any hazards, it is to document the reasons for its determination in its decision-making documents (9 CFR 417.5). Under this final rule, if establishments that use air inflation maintain controls outside of their HACCP plans to ensure that air inflation procedures do not cause insanitary conditions or adulterate product, they are to incorporate such controls into their Sanitation SOPs or another prerequisite program. FSIS will verify that establishments that choose to use air inflation procedures implement and maintain controls that are adequate and effective to ensure that the procedures do not cause insanitary conditions or adulterate product. The Agency will verify the effectiveness of these controls by reviewing establishment records and directly observing the air inflation procedures. It will also verify that establishments that use air inflation have incorporated their procedures for inflating meat carcasses and parts into their HACCP plan or Sanitation SOP or other prerequisite program. In addition, FSIS will assess whether these establishments verify on an ongoing basis that their controls are effectively preventing insanitary conditions and adulteration during air inflation. This rule will provide establishments with more production options and will encourage the development of new technology without diminishing food safety. The proposed rule noted that on January 12, 2004, FSIS amended 9 CFR 310.13(a)(2)(iv)(D) to prohibit the use of compressed air injection into the skull of cattle in conjunction with a captive bolt stunner (75 FR 28763). The 2004 rule also amended FSIS's humane slaughter regulations (9 CFR 313.15 (b)(2)(ii)) to prohibit the use of captive bolt stunners that deliberately inject compressed air into the cranium of cattle. In this final rule, FSIS is adding a new paragraph (310.13(b)(2)) to the regulations stating that establishments may not inject compressed air into the skulls of cattle in conjunction with a captive bolt stunner to hold the animal still for dressing operations. The Agency is adding this paragraph to clarify that the prohibition against injecting compressed air into the skulls of cattle remains in force and to ensure that the prohibition is retained in both sections of the FSIS regulations that apply to air injection procedures. Executive Order 12866 and the Regulatory Flexibility Act This action has been reviewed for compliance with Executive Order 12866. The Office of Management and Budget has designated this proposed rule “non-significant” and therefore has not reviewed it. Meat Industry Overview Excluding slaughtering only and raw-ground meat processing only, there are about 2,818 federally inspected establishments, which, under this rule, could adopt air inflation technology to process raw-not-ground meat. 1 Furthermore, of the 2,818 federally inspected establishments, approximately 1,541 are considered very small (with less than 10 employees), 1,153 are considered small (with between 10 and 500 employees), and 124 are considered large (with more than 500 employees). 2 1 Performance Based Inspection System. 2009. 2 *Ibid.* Estimated Benefits Allowing for greater ease in introducing new air inflation technology and procedures will likely spur technological innovation that will provide this new technology to additional meat establishments. Greater technological innovation more widely used by industry would likely result in increased net higher-value meat yields, which would lead to consumer savings. Estimated Costs Under this rule, establishments will be required to incorporate their controls for air inflation procedures into their HACCP plan or Sanitation SOP or other prerequisite program. FSIS does not anticipate any new costs associated with this rule because the HACCP regulations already require that establishments consider the steps of each process, including procedures such as air inflation, as part of their hazard analysis and HACCP plan. Because the use of air inflation procedures is voluntary, establishments would not incur any costs associated with the use of air inflation procedures unless they expected to realize net benefits from the use of the new technology. Therefore, this rule will result in negligible costs but would provide benefits. Regulatory Flexibility Analysis As required by the Regulatory Flexibility Act (5 U.S.C. 601-612), the FSIS Administrator has examined the economic implications of the rule and has determined that it will not have a significant impact on a substantial number of small entities. Under the rule, no establishments are required to use air inflation procedures to inflate meat carcasses or parts, and establishments are only likely to do so if they would expect to realize profits by employing such methods. Executive Order 12988 This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under this rule:

(1)All State and local laws and regulations that are inconsistent with this rule will be preempted;

(2)no retroactive effect will be given to this rule; and

(3)no retroactive proceedings will be required before parties may file suit in court challenging this rule. Paperwork Requirements FSIS has reviewed this rule under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and has determined that the information collection related to HACCP plans, Sanitation SOPs, and prerequisite programs has been approved by OMB under OMB Control Number 0583-0103. E-Government Act FSIS and USDA are committed to achieving the purposes of the E-Government Act (44 U.S.C. 3601, *et seq.* ) by, among other things, promoting the use of the Internet and other information technologies and providing increased opportunities for citizen access to government information and services, and for other purposes. Executive Order 13175 The policies contained in this rule do not have Tribal Implications that preempt Tribal Law. USDA Nondiscrimination Statement The U.S. Department of Agriculture

(USDA)prohibits discrimination in all its programs and activities on the basis of race, color, national origin, gender, religion, age, disability, political beliefs, sexual orientation, and marital or family status. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact USDA's Target Center at 202-720-2600 (voice and TTY). To file a written complaint of discrimination, write USDA, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue, SW., Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY). USDA is an equal opportunity provider and employer. Additional Public Notification Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that the public and in particular minorities, women, and persons with disabilities, are aware of this final rule, FSIS will announce it on-line through the FSIS Web page located at *http://www.fsis.usda.gov/regulations/2010_Interim _&_Final_Rules_Index.* FSIS also will make copies of this **Federal Register** publication available through the *FSIS Constituent Update,* which is used to provide information regarding FSIS policies, procedures, regulations, **Federal Register** notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The *Update* is communicated via Listserv, a free e-mail subscription service consisting of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals who have requested to be included. The *Update* also is available on the FSIS Web page. Through Listserv and the Web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an e-mail subscription service which provides automatic and customized access to selected food safety news and information. This service is available at *http://www.fsis.usda.gov/news_&_events/email_subscription/.* Options range from recalls to export information to regulations, directives and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts. List of Subjects in 9 CFR Part 310 Meat inspection. Accordingly, the Food Safety and Inspection Service amends 9 CFR part 310 as follows: PART 310—POST-MORTEM INSPECTION 1. The authority citation for part 310 continues to read as follows: Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53. 2. Amend § 310.13 by revising paragraph (a), redesignating paragraph

(b)as paragraph (b)(1), and adding paragraph (b)(2) to read as follows: § 310.13 Inflating carcasses or parts thereof; transferring caul or other fat.

(a)Establishments that slaughter livestock and prepare livestock carcasses and parts may inflate carcasses or parts of carcasses with air if they develop, implement, and maintain controls to ensure that the air inflation procedure does not cause insanitary conditions or adulterate product. Establishments shall incorporate these controls into their HACCP plans or Sanitation SOPs or other prerequisite programs. (b)(1) * * *

(2)Injecting compressed air into the skulls of cattle in conjunction with a captive bolt stunner to hold the animal still for dressing operations is prohibited. Done at Washington, DC, on October 29, 2010. Alfred V. Almanza, Administrator. [FR Doc. 2010-28650 Filed 11-12-10; 8:45 am]

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