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Code · REGISTER · 2008-04-17 · PROPOSED RULES · AID Agency for International Development NOTICES Privacy Act; Systems of Records, 20905-20906 E8-8240 Agricultural Agricultural Marketing Service PROPOSED RULES User Fees for 2008 Crop Cotton Classifi · Unknown

Unknown. Final rule; technical amendments

17,024 words·~77 min read·/register/2008/04/17/08-1142

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

--- schema: federal-register doc_type: fedreg source_file: FR-2008-04-17.xml --- 73 75 Thursday, April 17, 2008 Contents AID Agency for International Development NOTICES Privacy Act; Systems of Records, 20905-20906 E8-8240 Agricultural Agricultural Marketing Service PROPOSED RULES User Fees for 2008 Crop Cotton Classification Services to Growers, 20842-20843 08-1148 Agriculture Agriculture Department See Agricultural Marketing Service See Forest Service NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 20906-20907 E8-8264 Centers Centers for Disease Control and Prevention NOTICES Meetings: Board of Scientific Counselors, Coordinating Center for Infectious Diseases, 20926-20927 E8-8336 Disease, Disability, and Injury Prevention and Control, 20927 E8-8326 National Institute for Occupational Safety and Health; Draft Document Available for Public Comment., 20927 E8-8259 Centers Centers for Medicare & Medicaid Services RULES Medicare Program;
Modification to the Weighting Methodology Used to Calculate the Low-income Benchmark Amount; Correction, 20804-20807 08-1136 CIA Central Intelligence Agency PROPOSED RULES Freedom of Information Act; Implementation, 20882-20884 E8-8090 Coast Guard Coast Guard RULES Security Zone; Anacostia River, Washington, DC, 20797-20799 08-1146 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration Consumer Consumer Product Safety Commission NOTICES Understanding the Pending Lead Legislation and the Use of Lead in Consumer Products, 20919 E8-8285 Drug Drug Enforcement Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 20951-20953 E8-8275 E8-8279 Election Election Assistance Commission NOTICES Meetings; Sunshine Act, 20919-20920 E8-8287 E8-8289 Employment Employment and Training Administration NOTICES Eligibility to Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance; Amended Certification: Determinations, 20953-20954 E8-8244 Investigations, 20954-20956 E8-8243 Jockey International, Inc., 20956 E8-8247 Johnson Rubber Co., 20956 E8-8250 Leach & Garner Co., 20956-20957 E8-8248 Rowe Furniture, Inc., 20957 E8-8246 The Hoover Co., 20957-20958 E8-8245 E8-8249 Termination of Investigation:
BIO-RAD Laboratories, Waltham, MA, 20958 E8-8251 Jockey International, Inc., 20958 E8-8242 EPA Environmental Protection Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 20920-20921 E8-8330 Meetings: Security and Prosperity Partnership, 20921-20923 E8-8329 Public Water System Supervision Program Revision for the State of Arkansas, 20923-20924 E8-8331 Executive Executive Office of the President See Central Intelligence Agency FAA Federal Aviation Administration RULES Class E Airspace:
Hawesville, KY; Removal, 20780-20781 E8-8061 Class E Airspace: New Albany, MS New Albany, MS, 20781 E8-8063 Establishment of Class D Airspace: Sherman, Texas, 20781-20782 E8-8055 PROPOSED RULES Class D Airspace: San Bernardino International Airport, San Bernardino, CA, 20843-20844 E8-8311 Congestion Management Rule for LaGuardia Airport, 20846-20868 E8-8308 Modification of Area Navigation Route Q-110 and Jet Route J-73; Florida, 20844-20846 E8-8227 FCC Federal Communications Commission RULES Radio Broadcasting Services;
Ash Fork and Paulden, Arizona, 20840 E8-8087 Radio Broadcasting Services; Clayton, Oklahoma, 20841 E8-8086 NOTICES Meetings; Sunshine Act, 20924 E8-8306 Federal Emergency Federal Emergency Management Agency RULES Changes in Flood Elevation Determinations, 20807-20810 E8-8325 Final Flood Elevation Determinations, 20810-20840 E8-8310 PROPOSED RULES Proposed Flood Elevation Determinations, 20890-20900 E8-8323 E8-8324 Federal Reserve Federal Reserve System RULES Definitions of Terms and Exemptions Relating to the Broker Exceptions for Banks, 20779-20780 E8-8270 Fish Fish and Wildlife Service PROPOSED RULES Subsistence Management Regulations for Public Lands in Alaska;
(2009 and 2010 and 2010-2011), 20884-20887 E8-7854 Regulations: Subsistence Taking of Fish and Shellfish Regulations, 20887-20890 E8-7841 NOTICES Draft Environmental Impact Statement: Yukon Flats National Wildlife Refuge, AK, 20931 E8-8263 Marine Mammal Protection Act; Stock Assessment Report, 20931-20932 E8-8209 Food Food and Drug Administration RULES Use of Materials Derived From Cattle in Human Food and Cosmetics, 20785-20794 08-1142 Forest Forest Service PROPOSED RULES Subsistence Management Regulations for Public Lands in Alaska;
(2009 and 2010 and 2010-2011), 20884-20887 E8-7854 Regulations: Subsistence Taking of Fish and Shellfish Regulations, 20887-20890 E8-7841 GSA General Services Administration RULES Federal Management Regulation: FMR Case 2007-102-2, Sale of Personal Property-Federal Asset Sales Sales Centers, 20799-20804 E8-8314 NOTICES Real Property Federal Asset Sales, 20924-20925 E8-8312 Health Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Food and Drug Administration See National Institutes of Health PROPOSED RULES Regulation on the Organizational Integrity of Entities Implementing Leadership Act Programs and Activities, 20900-20904 08-1147 NOTICES Secretary's Advisory Committee on Genetics, Health, and Society, 20925-20926 E8-8216 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency See U.S.
Customs and Border Protection Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 20930-20931 E8-8318 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See National Park Service See Reclamation Bureau IRS Internal Revenue Service RULES Employer Comparable Contributions to Health Savings Accounts Under Section 4980G, 20794-20797 E8-8214 PROPOSED RULES Regulations Under Section 2642(g), 20870-20877 E8-8033 Withdrawal of Regulations under Old Section, 20877-20882 E8-8082 International International Trade Administration NOTICES Certain Polyester Staple Fiber from Taiwan:
Preliminary Results of Antidumping Duty Administrative Review, 20907-20910 E8-8299 Justice Justice Department See Drug Enforcement Administration NOTICES Lodging of Consent Decree: United States v. Weyerhaeuser Co., 20950-20951 E8-8280 Lodging of Consent Decree: Under The Comprehensive Environmental Response, Compensation, and Liability Act United States, et al., v. BHP Hawaii, Inc., 20951 E8-8281 Lodging of Stipulation and Order of Settlement Under The Clean Water Act, 20951 E8-8274 Labor Labor Department See Employment and Training Administration Land Land Management Bureau NOTICES Meetings:
Western Montana, Central Montana, Eastern Montana, and Dakotas Resource Advisory Council, 20933 E8-8260 Proposed Reinstatement of Terminated Oil and Gas Lease, 20933-20934 E8-8237 E8-8238 Public Land Order No. 7704: Partial Revocation of Public Land Order No. 1483; Utah, 20934 E8-8321 Legal Legal Services Corporation NOTICES Meetings; Sunshine Act, 20958-20961 08-1151 Maritime Maritime Administration NOTICES Port Dolphin Energy LLC, Port Dolphin Energy Liquefied Natural Gas Deepwater Port License Application, 21012-21014 E8-8343 NIH National Institutes of Health NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 20927-20928 E8-8230 Government-Owned Inventions; Availability for Licensing, 20928-20930 E8-8213 E8-8218 Meetings: National Institute of Mental Health, 20930 E8-8226 NOAA National Oceanic and Atmospheric Administration PROPOSED RULES Establishment of Marine Reserves and a Marine Conservation Area Within the Channel Islands National Marine Sanctuary, 20869-20870 E8-7916 NOTICES Meetings: Caribbean Fishery Management Council, 20910 E8-8234 New England Fishery Management Council, 20910 E8-8284 North Pacific Fishery Management Council, 20910-20911 E8-8235 South Atlantic Fishery Management Council, 20911-20912 E8-8286 Privacy Act;
Systems of Records, 20912-20918 E8-8241 E8-8257 Taking and Importing Marine Mammals; Navy Training and Research, Development, Testing, and Evaluation Activities Conducted within the Southern California Ra, 20918-20919 E8-8283 National Park National Park Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 20934-20936 E8-8137 Intent to Repatriate Cultural Items: American Museum of Natural History, New York, NY, 20936-20937 E8-8295 Inventory Completion:
California Department of Parks and Recreation, Sacramento, CA, 20937-20939 E8-8301 Denver Museum of Nature & Science, Denver, CO, 20939-20941 E8-8291 Kingman Museum, Incorporated, Battle Creek, MI, 20941-20942 E8-8292 E8-8303 Michigan Technological University Department Of Social Sciences Archaeology Laboratory, Houghton, MI, 20942-20943 E8-8293 Oregon State University Department of Anthropology, Corvallis, OR, 20943-20948 E8-8294 E8-8298 E8-8300 E8-8313 E8-8315 E8-8316 E8-8319 U.S.
Department of Agriculture, Forest Service, Cibola National Forest, Albuquerque, NM, 20948-20949 E8-8307 U.S. Department of Homeland Security, U.S. Coast Guard, 13th Coast Guard District, Seattle, WA, and Oregon State University Department of Anthropology, Corv, 20949 E8-8290 U.S. Department of the Interior, Bureau of Land Management, Colorado State Office, Denver, CO, and Museum of Western Colorado, Grand Junction, CO, 20948 E8-8305 Nuclear Nuclear Regulatory Commission NOTICES Arizona Public Service Co.;
Consideration of Issuance of Amendment to Facility Operating License, Proposed, etc., 20961-20963 E8-8271 Conduct of New Reactor Licensing Proceedings; Final Policy Statement, 20963-20973 E8-8272 Reclamation Reclamation Bureau NOTICES Privacy Act; Systems of Records, 20949-20950 E8-8265 SEC Securities and Exchange Commission RULES Definitions of Terms and Exemptions Relating to the Broker Exceptions for Banks, 20779-20780 E8-8270 Self-Regulatory Organizations; Proposed Rule Changes, 20782 E8-8267 NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 20973-20976 E8-8182 E8-8183 Filing: American Stock Exchange LLC, Boston Stock Exchange, Inc., Chicago Board Options Exchange, Inc., et al., 20976-20980 E8-8195 Order of Summary Abrogation: NYSE Arca, Inc., 20981 E8-8215 Self-Regulatory Organizations; Proposed Rule Changes: American Stock Exchange LLC, 20981-20985 E8-8194 E8-8277 Chicago Board Options Exchange, Inc., 20985-20994 E8-8232 E8-8278 International Securities Exchange, LLC, 20994-20996 E8-8193 NYSE Arca, Inc., 20996-20999 E8-8276 The Fixed Income Clearing Corp., 20999-21001 E8-8233 The NASDAQ Stock Market LLC, 21002-21007 E8-8268 E8-8269 State State Department NOTICES Bureau of Educational and Cultural Affairs Request for Grant Proposals:
Junior Faculty Development Program, 21007-21011 E8-8322 Surface Surface Transportation Board NOTICES Acquisition and Operation Exemption: SSP Railroad Holding LLC; Mittal Steel USA - Railways Inc., 21014 E8-7962 Minnesota Commercial Railway Company—Adverse Discontinuance—In Ramsey County, MN, 21014-21015 E8-8288 Trackage Rights Exemption: R.J. Corman Railroad Co./Central Kentucky Lines, LLC; CSX Transportation, Inc., 21015-21016 E8-8159 Transportation Transportation Department See Federal Aviation Administration See Maritime Administration See Surface Transportation Board NOTICES Order to Show Cause (Order 2008-4-18):
Mccall Aviation, Inc., 21012 E8-8262 Treasury Treasury Department See Internal Revenue Service RULES Entry of Softwood Lumber Products From Canada, 20782-20785 E8-8095 NOTICES Meetings: Advisory Committee on the Auditing Profession, 21016 E8-8212 Customs U.S. Customs and Border Protection RULES Entry Of Softwood Lumber Products From Canada, 20782-20785 E8-8095 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 73 75 Thursday, April 17, 2008 Rules and Regulations FEDERAL RESERVE SYSTEM 12 CFR Part 218 [Regulation R; Docket No. R-1274] SECURITIES AND EXCHANGE COMMISSION 17 CFR Part 247 [Release No. 34-56501A; File No. S7-22-06] RIN 3235-AJ74 Definitions of Terms and Exemptions Relating to the “Broker” Exceptions for Banks AGENCIES:
Board of Governors of the Federal Reserve System (“Board”) and Securities and Exchange Commission (“SEC” or “Commission”) (collectively, the Agencies). ACTION: Final rule; technical amendments. SUMMARY: The Board and the Commission jointly are adopting technical amendments to Regulation R, which the Agencies jointly adopted in September 2007. Regulation R implements certain of the exceptions for banks from the definition of the term “broker” in section 3(a)(4) of the Securities Exchange Act of 1934 (“Exchange Act”), as amended by the Gramm-Leach-Bliley Act (“GLBA”).
The technical amendments correct cross-references and other typographical errors in the regulation. DATES: *Effective Date:* The technical amendments are effective April 17, 2008. *Compliance Date:* As provided in 12 CFR 218.781 and 17 CFR 247.100 of Regulation R, banks are exempt from complying with Regulation R and the “broker” exceptions in section 3(a)(4)(B) of the Exchange Act until the first day of their first fiscal year that commences after September 30, 2008. FOR FURTHER INFORMATION CONTACT: *Board:* Andrea Tokheim, Counsel,
(202)452-2300, or Brian Knestout, Attorney,
(202)452-2249, Legal Division, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue, NW., Washington, DC 20551. Users of Telecommunication Device for Deaf
(TDD)only, call
(202)263-4869. *SEC:* Linda Stamp Sundberg, Senior Special Counsel, at
(202)551-5550, Office of the Chief Counsel, Division of Trading and Markets, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549. SUPPLEMENTARY INFORMATION: A. Overview of Technical Amendment In September 2007, the Board and the SEC jointly adopted a single set of final rules called Regulation R that implement certain of the exceptions for banks from the definition of the term “broker” in section 3(a)(4) of the Exchange Act, as amended by the GLBA. 1 Regulation R defines terms used in these statutory exceptions and includes certain related exemptions. The Board and the SEC are jointly adopting these technical amendments to correct certain cross-references and typographical errors in the final rules. 1 *See* 72 FR 56514, Oct. 3, 2007, which added parts 12 CFR 218 and 17 CFR 247 to the Code of Federal Regulations. In particular, paragraph
(b)of Rule 701 is revised to add a colon at the end of the paragraph. 2 Paragraphs (a)(6) and (a)(7) of Rule 721 are redesignated as paragraphs (a)(5) and (a)(6) because there was no numbered paragraph (a)(5). Paragraph (c)(2) of Rule 721 is revised to correctly cross-reference paragraph (h)(2), rather than paragraph (g)(2). Paragraph (e)(3) of Rule 723 is revised to correctly refer to “this paragraph (e)”, rather than “this paragraph (d)”. For consistency, paragraphs (a)(1)(A) and (a)(1)(B) of Rule 741 are redesignated as paragraphs (a)(1)(i) and (a)(1)(ii). Finally, paragraph (b)(1)(i) of Rule 775 is revised to add a dash to the citation of 15 U.S.C. 80a-5(a)(1). 2 The final rules adopted by the Board and the SEC within their respective titles of the Code of Federal Regulations (12 CFR part 218 for the Board and 17 CFR part 247 for the SEC) are identically numbered from § _.100 to § _.781. For ease of reference, the single set of final rules adopted by each Agency are referred to in this release as Rule _, excluding title and part designations. A similar format was used to refer to the single set of rules issued by the Agencies. B. Administrative Procedure Act The Agencies find, in accordance with sections 553(b) and
(d)of the Administrative Procedure Act, 3 that good cause exists to make these amendments effective upon publication in the **Federal Register** without providing prior notice and an opportunity for comment. Specifically, the Agencies find that notice and comment and a delayed effective date are unnecessary because the amendments make only technical changes to Regulation R and there is no substantive change on which the public could provide meaningful comment. 4 3 5 U.S.C. 553(b)(3)(A) and (d)(3). 4 For similar reasons, the amendments do not require analysis under the Regulatory Flexibility Act or analysis of major rule status under the Small Business Regulatory Enforcement Fairness Act. See 5 U.S.C. 601(2) (for purposes of Regulatory Flexibility Act analyses, the term “rule” means any rule for which the agency publishes a general notice of proposed rulemaking); 5 U.S.C. 804(3)(C) (for purposes of Congressional review of agency rulemaking, the term “rule” does not include any rule of agency organization, procedure, or practice that does not substantially affect the rights or obligations of non-agency parties). C. Paperwork Reduction Act Finally, the technical amendments do not contain any new or additional collections of information as defined by the Paperwork Reduction Act of 1995, as amended. 5 5 44 U.S.C. 3501. List of Subjects 12 CFR Part 218 Banks, Brokers, Securities. 17 CFR Part 247 Banks, Brokers, Securities. Federal Reserve System Authority and Issuance For the reasons set forth in the preamble, the Board amends 12 CFR part 218 as set forth below: PART 218—REGULATION R—EXCEPTIONS FOR BANKS FROM THE DEFINITION OF BROKER IN THE SECURITIES EXCHANGE ACT OF 1934 (REGULATION R) 1. The Authority citation for part 218 continues to read as follows: Authority: 15 U.S.C. 78c(a)(4)(F). Securities and Exchange Commission Authority and Issuance For the reasons set forth in the preamble, the Commission amends 17 CFR part 247 as set forth below: PART 247—REGULATION R—EXEMPTIONS AND DEFINITIONS RELATED TO THE EXCEPTIONS FOR BANKS FROM THE DEFINITION OF BROKER 2. The authority citation for part 247 continues to read as follows: Authority: 15 U.S.C. 78c, 78 *o* , 78q, 78w, and 78mm. Common Rules The common rules adopted by the Board as Part 218 of Title 12, Chapter II of the Code of Federal Regulations and by the Commission as Part 247 of Title 17, Chapter II of the Code of Federal Regulations are amended as follows: 3. Paragraph
(b)of common rule § _.701 is revised to read as follows: § _.701 Exemption from the definition of “broker” for certain institutional referrals.
(b)*Required disclosures.* The disclosures provided to the high net worth customer or institutional customer pursuant to paragraphs (a)(2)(i) or (a)(3)(i) of this section shall clearly and conspicuously disclose: 4. In common rule § _.721, paragraphs (a)(6) and (a)(7) are redesignated as paragraphs (a)(5) and (a)(6), respectively, and paragraph (c)(2) is revised to read as follows: § _.721 Defined terms relating to the trust and fiduciary activities exception from the definition of “broker.”
(c)* * *
(2)*Advertisement.* For purposes of this section, the term *advertisement* has the same meaning as in § _.760(h)(2). 5. Paragraph (e)(3) of common rule § _.723 is revised to read as follows: § _.723 Exemptions for special accounts, transferred accounts, foreign branches and a de minimis number of accounts.
(e)* * *
(3)The bank did not rely on this paragraph
(e)with respect to such account during the immediately preceding year. § _.741 [Amended] 6. In common rule § _.741, paragraphs (a)(1)(A) and (a)(1)(B) are redesignated as paragraphs (a)(1)(i) and (a)(1)(ii), respectively. 7. In common rule § _.775, paragraph (b)(1)(i) is revised to read as follows: § _.775 Exemption from the definition of “broker” for banks effecting certain excepted or exempted transactions in investment company securities.
(b)* * *
(1)* * *
(i)Any security issued by an open-end company, as defined by section 5(a)(1) of the Investment Company Act (15 U.S.C. 80a-5(a)(1)), that is registered under that Act; and By order of the Board of Governors of the Federal Reserve System, acting through the Secretary of the Board under delegated authority, April 11, 2008. Robert deV. Frierson, Deputy Secretary of the Board. Dated: April 11, 2008. Florence Harmon, By the Securities and Exchange Commission, Deputy Secretary. [FR Doc. E8-8270 Filed 4-16-08; 8:45 am] BILLING CODE 6210-01-P; 8010-01-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2008-0334; Airspace Docket No. 08-ASO-11] Removal of Class E Airspace; Hawesville, KY AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This action removes the Class E5 Airspace at Hancock Airfield Airport, Hawesville, KY, as there is no longer a Standard Instrument Approach Procedure
(SIAP)for Hancock Airfield Airport requiring Class E5 airspace. DATES: Effective 0901 UTC, July 31, 2008. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments. FOR FURTHER INFORMATION CONTACT: Melinda Giddens, System Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone
(404)305-5610. SUPPLEMENTARY INFORMATION: History The Hancock Airfield Airport has closed and a new airport, Lewisport-Hancock County, has been built in the area. As a result, the associated Standard Instrument Approach Procedures (SIAPs) were withdrawn and cancelled removing the Class E5 airspace requirement at Hancock Airfield. New SIAPs are being developed for the new Lewisport/Hancock County Airport, however, the procedures and associated airspace are not scheduled for publication until September of 2009. This rule will become effective on the date specified in the DATES section. Since this action eliminates the impact of controlled airspace on users of the National Airspace System in the vicinity of the Hancock County Airport, notice and public procedure under 5 U.S.C. 553(b) are unnecessary. Class E airspace designations for airspace areas extending upward from 700 feet or more above the surface of the earth are published in Paragraph 6005 of FAA Order 7400.9R, signed August 15, 2007, and effective September 15, 2007, which is incorporated by reference in 14 CFR 71.1. The Class E designation listed in this document will be removed from publication subsequently in the Order. The Rule This amendment to Part 71 of the Federal Aviation Regulations (14 CFR part 71) removes Class E5 airspace at Hancock Airfield Airport, Hawesville, KY. The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is noncontroversial and unlikely to result in adverse or negative comments. It, therefore,
(1)is not a “significant regulatory action” under Executive Order 12866;
(2)is not a “significant rule'' under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and
(3)does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it removes controlled airspace at Hancock Airfield Airport, Hawesville, KY. Lists of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (Air). Adoption of the Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows: PART 71—DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., P. 389. § 71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.9R, Airspace Designations and Reporting Points, signed August 15, 2007, effective September 15, 2007, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ASO KY E5 Hawesville, KY [Remove] Issued in College Park, Georgia, on March 31, 2008. Mark D. Ward, Acting Manager, System Support Group, Eastern Service Center, Air Traffic Organization (ATO). [FR Doc. E8-8061 Filed 4-16-08; 8:45 am] BILLING CODE 4910-13-M DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2007-0161; Airspace Docket No. 07-ASO-25] Establishment of Class E Airspace; New Albany, MS AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule; confirmation of effective date. SUMMARY: This action confirms the effective date of a direct final rule published in the **Federal Register** (73 FR 5434) that establishes a Class E airspace area to support Area Navigation
(RNAV)Global Positioning System
(GPS)Standard Instrument Approach Procedures
(IAPs)that serve the New Albany-Union County Airport, New Albany, MS. DATES: Effective 0901 UTC, April 10, 2008. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments. FOR FURTHER INFORMATION CONTACT: Daryl Daniels, Airspace Specialist, System Support, AJO2-E2B.12, FAA Eastern Service Center, 1701 Columbia Ave., College Park, GA 30337; telephone
(404)305-5581; fax
(404)305-5572. SUPPLEMENTARY INFORMATION: Confirmation of Effective Date The FAA published this direct final rule with a request for comments in the **Federal Register** on January 30, 2008 (73 FR 5434), Docket No. FAA-2007-0161; Airspace Docket No. 07-ASO-25. The FAA uses the direct final rulemaking procedure for a non controversial rule where the FAA believes that there will be no adverse public comment. This direct final rule advised the public that no adverse comments were anticipated, and that unless a written adverse comment, or a written notice of intent to submit such an adverse comment, were received within the comment period, the regulation would become effective on April 10, 2008. No adverse comments were received, and thus this notice confirms that effective date. Issued in College Park, GA on April 2, 2008. Barry A. Knight, Acting Manager, System Support Group, Eastern Service Center, Air Traffic Organization. [FR Doc. E8-8063 Filed 4-16-08; 8:45 am] BILLING CODE 4910-13-M DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR, Part 71 [Docket No. FAA-2007-29374; Airspace Docket No. 07-ASW-11] Establishment of Class D Airspace; Sherman, TX AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This action will establish Class D airspace at Sherman, Texas. Establishment of an Air Traffic Control Tower at Sherman/Denison, Grayson County Airport, has made this action necessary for the safety and management of Instrument Flight Rules
(IFR)aircraft operations at Sherman/Denison, Grayson County Airport, Sherman, Texas. DATES: *Effective Date:* 0901 UTC, June 5, 2008. The Director of the Federal Register approves this incorporation by reference action under 1 CFR, Part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments. FOR FURTHER INFORMATION CONTACT: Gary Mallett, Central Service Center, System Support Group, Federal Aviation Administration, Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76193-0530; telephone
(817)222-4949. SUPPLEMENTARY INFORMATION: History On December 18, 2007, the FAA published in the **Federal Register** a notice of proposed rulemaking to establish Class D airspace at Sherman, TX (72 FR 71607). This action would improve the safety of IFR aircraft at Sherman/Denison, Grayson County Airport, Sherman, TX. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received. Class D airspace designations are published in paragraph 5000 of FAA Order 7400.9R signed August 15, 2007, and effective September 15, 2007, which is incorporated by reference in 14 CFR, Part 71.1. The Class D airspace designations listed in this document will be published subsequently in that Order. The Rule This action amends Title 14 Code of Federal Regulations (14 CFR), part 71, by establishing Class D airspace extending upward from the surface to and including 3,300 feet Mean Sea Level
(MSL)within a 5-mile radius of Sherman/Denison, Grayson County Airport. The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation:
(1)Is not a ``significant regulatory action'' under Executive Order 12866;
(2)is not a ”significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and
(3)does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. The FAA authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at Sherman/Denison, Grayson County Airport, Sherman, TX. List of Subjects in 14 CFR, Part 71 Airspace, Incorporation by reference, Navigation (air). Adoption of the Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR, part 71, as follows: PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for 14 CFR, part 71, continues to read as follows: Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; EO. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389. § 71.1 [Amended] 2. The incorporation by reference in 14 CFR, part 71.1 of the Federal Aviation Administration Order 7400.9R, Airspace Designations and Reporting Points, signed August 15, 2007, and effective September 15, 2007, is amended as follows: Paragraph 5000 Class D Airspace. ASW TX D Sherman, TX [New] Sherman/Denison, Grayson County Airport, TX (Lat. 33°42′51″ N., long. 96°40′25″ W.) That airspace extending upward from the surface to and including 3,300 feet MSL within a 5.0-mile radius of Grayson County Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory. Issued in Fort Worth, Texas, on: April 4, 2008. Walter Tweedy, Acting Manager, System Support Group, ATO Central Service Center. [FR Doc. E8-8055 Filed 4-16-08; 8:45 am] BILLING CODE 4910-13-M SECURITIES AND EXCHANGE COMMISSION 17 CFR Parts 240 and 249 [Release 34-57526A; File No. S7-06-07] RIN 3235-AJ80 Proposed Rule Changes of Self-Regulatory Organizations AGENCY: Securities and Exchange Commission. ACTION: Final rule; Correction. SUMMARY: The Securities and Exchange Commission (“Commission”) published in the **Federal Register** of March 27, 2008 (72 FR 16179), a document concerning proposed rule changes by Self-Regulatory Organizations submitted pursuant to Section 19(b)(7)(A) of the Securities Exchange Act of 1934. DATES: *Effective Date:* April 28, 2008. FOR FURTHER INFORMATION CONTACT: John Roeser, Assistant Director, at
(202)551-5630, Michou Nguyen, Special Counsel, at
(202)551-5634, or Sherry Moore, Paralegal, at
(202)551-5549, Division of Trading and Markets, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-6628. SUPPLEMENTARY INFORMATION: This document corrects the comment due date that was incorrectly stated in the sample 19(b)(7)(A) release published with the final rule. In rule document E8-5998 beginning on page 16179 in the issue of Thursday, March 27, 2008, make the following correction: On page 16196, in the third column, the phrase “should be submitted on or before April 17, 2008.” is corrected to read “should be submitted on or before May 8, 2008. Dated: April 14, 2008. Nancy M. Morris, Secretary. [FR Doc. E8-8267 Filed 4-16-08; 8:45 am] BILLING CODE 8010-01-P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection DEPARTMENT OF THE TREASURY 19 CFR Parts 12, 113 and 163 [CBP Dec. 08-10; USCBP-2006-0108] RIN 1505-AB73 Entry of Softwood Lumber Products From Canada AGENCIES: U.S. Customs and Border Protection, Department of Homeland Security; Department of the Treasury. ACTION: Final rule. SUMMARY: This document adopts as a final rule, with changes, the interim rule amending title 19 of the Code of Federal Regulations (19 CFR) that was published in the **Federal Register** (71 FR 61399) on October 18, 2006 as Customs and Border Protection
(CBP)Dec. 06-25. The interim rule amended the CBP regulations by prescribing the collection of certain entry summary information for purposes of monitoring and enforcing the Softwood Lumber Agreement (SLA 2006) between the Governments of Canada and the United States, entered into on September 12, 2006. In an effort to better enable CBP to accurately and timely fulfill its data collection and reporting obligations under the SLA 2006, this document identifies an additional entry code option that designates softwood lumber products that are specifically identified as exempt from SLA 2006 export measures pursuant to Annex 1A of the Agreement, notwithstanding the fact that the exempt goods are classifiable in residual Harmonized Tariff Schedule of the United States provisions that are listed as covered by the SLA 2006. This document also amends the list of required entry records set forth in the Appendix to part 163 of title 19 of the Code of Federal Regulations (19 CFR part 163) to reflect the recordkeeping requirements prescribed in CBP Dec. 06-25. Lastly, this document conforms the bond provisions applicable to certain imports of Canadian softwood lumber to reflect the softwood lumber provisions set forth in § 12.140 of title 19 of the Code of Federal Regulations. DATES: *Effective Date:* April 17, 2008. FOR FURTHER INFORMATION CONTACT: Millie Gleason, Office of International Trade, Tel:
(202)863-6557. SUPPLEMENTARY INFORMATION: Background On September 12, 2006, the Governments of the United States and Canada (the “Parties”) signed a bilateral Softwood Lumber Agreement (“SLA 2006”) concerning trade in softwood lumber products. On October 18, 2006, Customs and Border Protection
(CBP)published in the **Federal Register** (71 FR 61399), as CBP Dec. 06-25, an interim rule amending § 12.140 of title 19 of the Code of Federal Regulations (19 CFR 12.140) to reflect the terms of the SLA 2006 by prescribing special entry requirements applicable to shipments of softwood lumber products from Canada. The interim amendments required importers to enter a letter code representing the softwood lumber product's Canadian Region of Origin in the data entry field entitled “Country of Origin” located on the CBP Form 7501. Importers were also required to enter a Canadian-issued 8-digit export permit number preceded by a letter code designating either:
(1)The date of shipment;
(2)a Canadian Region whose exports of softwood lumber products are exempt from the export measures contained in the SLA 2006; or
(3)a company listed in Annex 10 of the SLA 2006 as exempt from the Agreement's export measures. Importers of softwood lumber products from the Maritimes were required to provide CBP with the original paper Certificate of Origin issued by the Maritime Lumber Bureau with the paper entry summary documentation. CBP Dec. 06-25 also amended, on an interim basis, the “List of Records Required for the Entry of Merchandise” set forth in the Appendix to part 163 of title 19 of the CFR (19 CFR part 163) to reflect the entry document requirements mandated by the SLA 2006. Comments were solicited on the interim rule. Discussion of Comments Three comments were received in response to the solicitation of comments in CBP Dec. 06-25. One comment was retracted by the commenter. A description of the comments received, together with CBP's analyses, is set forth below. *Comment:* One commenter offered support for the requirement set forth in CBP Dec. 06-25 that an original Certificate of Origin from the Maritime Lumber Bureau must accompany each entry of softwood lumber into the United States and requested that this requirement be retained in the final rule. *CBP Response:* This entry requirement is retained in the final rule. *Comment:* One commenter suggested that CBP adopt two additional data-input requirements for imports of Canadian softwood lumber products. The commenter recommended that CBP require importers to disclose the “Export Price” of the merchandise within the meaning of Article XXI.25 of the SLA 2006. As defined in the agreement, the Export Price is the taxable value for purposes of calculating SLA 2006 export fees that Canada is obligated to collect. The commenter also suggests that CBP require importers of all Canadian softwood lumber products to declare the merchandise's “Date of Shipment” within the meaning of Article XXI.16 of the SLA 2006. The commenter asserts that this date is important because, depending on volumes shipped during specific periods (as determined by Date of Shipment), shipments from the Maritimes, the Territories, or by companies listed as excluded from export measures in the SLA 2006, can be subject to export measures notwithstanding normally applicable exemptions. The commenter notes that, under the terms of the interim rule, CBP is collecting Date of Shipment data regarding imports of most Canadian softwood lumber, but not on lumber produced in the Maritime Provinces, the Territories, or by excluded Canadian lumber producers. *CBP Response:* Pursuant to Article XV.B of the SLA 2006, the U.S. is obligated to provide Canada with the appraised value, as defined by CBP, for each entry of softwood lumber products filed during the preceding month. The U.S. does not collect export prices; exporters of softwood lumber to the U.S provide that data to Canada. The commenter correctly notes that CBP collects Date of Shipment data for all imports of softwood lumber covered by the SLA 2006, except for entries of softwood lumber that claim an exemption from the Agreement's export measures. Although CBP does not require Date of Shipment data for imports claiming exemption from SLA 2006 export measures, CBP collects the export date for these imports and uses that date to assess the Date of Shipment and, consequently, whether an exempt status remains valid for a given month. *Other Comments:* Additional comments were received after the close of the comment period proposing unilateral enforcement of the Softwood Lumber Agreement and the collection of additional information in order to determine if the correct amount of tax is actually collected by Canadian authorities. *CBP Response:* Such proposals exceed the scope of CBP authority and the requirements of the Softwood Lumber Agreement and consequently are not adopted in this document. Conclusion After review of the comments and further consideration, CBP has decided to adopt as final the interim rule published in the **Federal Register** (71 FR 61399) on October 18, 2006, as CBP Dec. 06-25, with the additional modifications set forth below. As noted above, CBP Dec. 06-25 identifies a series of letter codes that are to be used as prefixes for the export permit numbers entered on the CBP Form 7501. These codes designate either an exclusion from export measures based on a product's Region of Origin, or a company's exempt-status, or the date of shipment as defined in Article XXI.16 of the SLA 2006. These codes enable the United States to fulfill its information collection and exchange obligations under Article XV of the Agreement by being able to assess monthly volumes attributable to specific Regions and excluded companies. This document clarifies CBP Dec. 06-25 by providing importers with an additional entry code option, “P88888888”, which is used to designate entries of softwood lumber products that are specifically identified as exempt from SLA 2006 export measures pursuant to Annex 1A of the Agreement, notwithstanding the fact that the exempt goods are classifiable in residual Harmonized Tariff Schedule of the United States provisions that are otherwise listed as covered by the SLA 2006. In addition, § 12.140(b) and
(c)are amended to clarify that all entries of softwood lumber products must be submitted to CBP in an electronic format, except for entries of softwood lumber products whose region of origin is the Maritimes, which must be submitted to CBP in paper. The “List of Records Required for the Entry of Merchandise” set forth in the Appendix to part 163 of title 19 of the CFR (19 CFR part 163) is also amended by this document to clarify that, in addition to the Certificate of Origin issued by Canada's Maritime Lumber Bureau, the Canadian-issued Export Permit is a required entry document as per the SLA 2006 and 19 CFR 12.140(d). Lastly, this document conforms the bond provisions applicable to certain imports of Canadian softwood lumber, set forth in 19 CFR 113.62(k), to reflect the new organizational structure of the softwood lumber provisions set forth in 19 CFR 12.140. To that end, § 113.62(k) is amended by removing the reference to paragraph
(a)within § 12.140, and the existing time period of 20 days within which a principal must establish to the satisfaction of CBP that the applicable export permit has been issued by the Government of Canada is changed to 10 days to reflect the fact that, pursuant to the SLA 2006, the export permit number must be submitted to CBP at the time of entry summary. Inapplicability of Notice and Delayed Effective Date Requirements Pursuant to 5 U.S.C. 553(a)(1), public notice and a delayed effective date are inapplicable to this regulation because it involves a foreign affairs function of the United States. Executive Order 12866 Because this rule involves a foreign affairs function of the United States, it is not subject to Executive Order 12866 and has not been reviewed by the Office of Management and Budget. Regulatory Flexibility Act Because no notice of proposed rulemaking is required for this rule, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ) do not apply. Paperwork Reduction Act The collection of information referenced in this regulation, CBP Form 7501, has been previously reviewed and approved by the Office of Management and Budget in accordance with the requirements of the Paperwork Reduction Act (44 U.S.C. 3507) under OMB-assigned control number 1651-0022. Signing Authority This document is being issued in accordance with 19 CFR 0.1(a)(1). List of Subjects 19 CFR Part 12 Bonds, Customs duties and inspection, Entry of merchandise, Imports, Prohibited merchandise, Reporting and recordkeeping requirements, Restricted merchandise. 19 CFR Part 113 Bonds, Customs duties and inspection, Imports, Reporting and recordkeeping requirements, Surety bonds. 19 CFR Part 163 Customs duties and inspection, Reporting and recordkeeping requirements. Amendment to the Regulations For the reasons stated above, parts 12, 113 and 163 of title 19 of the Code of Federal Regulations are amended as set forth below. PART 12—SPECIAL CLASSES OF MERCHANDISE 1. The authority citation for part 12 continues to read in part as follows: Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202 (General Note 3(i), Harmonized Tariff Schedule of the United States (HTSUS)), 1624; 2. Section 12.140 is revised to read as follows: § 12.140 Entry of softwood lumber products from Canada. The requirements set forth in this section are applicable for as long as the Softwood Lumber Agreement (SLA 2006), entered into on September 12, 2006, by the Governments of the United States and Canada, remains in effect.
(a)*Definitions.* The following definitions apply for purposes of this section:
(1)*British Columbia Coast.* “British Columbia Coast” means the Coastal Forest Regions as defined by the existing *Forest Regions and Districts Regulation,* B.C. Reg. 123/2003.
(2)*British Columbia Interior.* “British Columbia Interior” means the Northern Interior Forest Region and the Southern Interior Forest Region as defined by the existing *Forest Regions and Districts Regulation,* B.C. Reg. 123/2003.
(3)*Date of shipment.* “Date of shipment” means, in the case of products exported by rail, the date when the railcar that contains the products is assembled to form part of a train for export; otherwise, the date when the products are loaded aboard a conveyance for export. If a shipment is transshipped through a Canadian reload center or other inventory location, the date of shipment is the date the merchandise leaves the reload center or other inventory location for final shipment to the United States.
(4)*Maritimes.* “Maritimes” means New Brunswick, Canada; Nova Scotia, Canada; Prince Edward Island, Canada; and Newfoundland and Labrador, Canada.
(5)*Region.* “Region” means British Columbia Coast or British Columbia Interior as defined in paragraphs (a)(1) and
(2)of this section; Alberta, Canada; Manitoba, Canada; Maritimes, Canada; Northwest Territories, Canada; Nunavut Territory, Canada; Ontario, Canada; Saskatchewan, Canada; Quebec, Canada; or Yukon Territory, Canada.
(6)*Region of Origin.* “Region of Origin” means the Region where the facility at which the softwood lumber product was first produced into such a product is located, regardless of whether that product was further processed (for example, by planing or kiln drying) or was transformed from one softwood lumber product into another such product (for example, a remanufactured product) in another Region, with the following exceptions:
(i)The Region of Origin of softwood lumber products first produced in the Maritime Provinces from logs originating in a non-Maritime Region will be the Region, as defined above, where the logs originated; and
(ii)The Region of Origin of softwood lumber products first produced in the Yukon, Northwest Territories or Nunavut (the ‘Territories’) from logs originating outside the Territories will be the Region where the logs originated.
(7)*SLA 2006.* “SLA 2006” or “SLA” means the Softwood Lumber Agreement entered into between the Governments of Canada and the United States on September 12, 2006.
(8)*Softwood lumber products.* “Softwood lumber products” mean those products described as covered by the SLA 2006 in Annex 1A of the Agreement.
(b)*Reporting requirements.* In the case of softwood lumber products from Canada listed in Annex 1A of the SLA 2006 as covered by the scope of the Agreement, the following information must be included on the electronic entry summary documentation (CBP Form 7501) for each entry (except for entries of softwood lumber products whose Region of Origin is the Maritimes, in which case entry summary documentation must be submitted in paper as set forth in paragraph
(c)of this section):
(1)*Region of Origin.* The letter code representing a softwood lumber product's Canadian Region of Origin, as posted on the Administrative Message Board in the Automated Commercial System. (For example, the letter code “XD” designates softwood lumber products whose Region of Origin is British Columbia Coast. The letter code “XE” designates softwood lumber products whose Region of Origin is British Columbia Interior.)
(2)*Export Permit Number* —(i) *Export Permit Number issued by Canada at time of filing entry summary documentation.* The 8-digit Canadian-issued Export Permit Number, preceded by one of the following letter codes:
(A)The letter code assigned to represent the date of shipment ( *i.e.* , “A” represents January, “B” represents February, “C” represents March, *etc.* ), except for those softwood lumber products produced by a company listed in Annex 10 of the SLA 2006 or whose Region of Origin is the Maritimes, Yukon, Northwest Territories or Nunavut;
(B)The letter code “X”, which designates a company listed in Annex 10 of the SLA 2006; or
(C)The letter code assigned to represent the Maritimes (code M); Yukon (code Y); Northwest Territories (code W); or Nunavut (code N), for softwood lumber products originating in these regions.
(ii)*No Export Permit Number required due to softwood lumber product's exempt status.* Where an Export Permit Number is not required because the imported softwood lumber product is specifically identified as exempt from SLA 2006 export measures pursuant to Annex 1A of the Agreement, notwithstanding the fact that the exempt goods are classifiable in residual Harmonized Tariff Schedule of the United States provisions otherwise listed as covered by the SLA 2006, the alpha-numeric code “P88888888” must be used in the Export Permit Number data entry field on the CBP Form 7501.
(c)*Original Maritime Certificate of Origin.* Where a softwood lumber product's Region of Origin is the Maritimes, the original paper copy of the Certificate of Origin issued by the Maritime Lumber Bureau must be submitted to CBP and the entry summary documentation for each such entry must be in paper and not electronic. The Certificate of Origin must specifically state that the corresponding CBP entries are for softwood lumber products first produced in the Maritimes from logs originating in the Maritimes or State of Maine.
(d)*Recordkeeping.* Importers must retain copies of export permits, certificates of origin, and any other substantiating documentation issued by the Canadian Government pursuant to the recordkeeping requirements set forth in part 163 of title 19 to the CFR. PART 113—CUSTOMS BONDS 3. The general authority citation for part 113 continues to read as follows: Authority: 6 U.S.C. 101, *et seq.;* 19 U.S.C. 66, 1623, 1624. § 113.62 [Amended] 4. In § 113.62, paragraph
(k)is amended by: a. Removing the term “§ 12.140(a)” and adding in its place the term “§ 12.140”; b. Removing the number “20” and adding in its place the number “10”; and c. Removing the word “Customs” and adding in its place the term “CBP”. PART 163—RECORDKEEPING 5. The authority citation for part 163 continues to read as follows: Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1484, 1508, 1509, 1510, 1624. 6. The Appendix to part 163 is amended by removing the listing for § 12.140(c) and adding in its place § 12.140(b) and
(c)under section IV to read as follows: Appendix to Part 163—Interim (a)(1)(A) List IV. * * * § 12.140(b) and
(c)Canadian-issued Export Permit, Certificate of Origin issued by Canada's Maritime Lumber Bureau. W. Ralph Basham, Commissioner, U.S. Customs and Border Protection. Approved: April 10, 2008. Timothy E. Skud, Deputy Assistant Secretary of the Treasury. [FR Doc. E8-8095 Filed 4-16-08; 8:45 am] BILLING CODE 9111-14-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 189 and 700 [Docket No. 2004N-0081] RIN 0910-AF47 Use of Materials Derived From Cattle in Human Food and Cosmetics AGENCY: Food and Drug Administration, HHS. ACTION: Interim final rule and request for comments. SUMMARY: The Food and Drug Administration
(FDA)is amending its regulations on the use of materials derived from cattle in human food and cosmetics. In these regulations, FDA has designated certain materials from cattle as “prohibited cattle materials” and has banned the use of such materials in human food, including dietary supplements, and in cosmetics. Prohibited cattle materials include specified risk materials (SRMs), the small intestine of all cattle unless the distal ileum is removed, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, or mechanically separated
(MS)(Beef). Specified risk materials include the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine of all cattle. FDA is amending its regulations so that FDA may designate a country as not subject to certain bovine spongiform encephalopathy (BSE)-related restrictions applicable to FDA regulated human food and cosmetics. A country seeking to be so designated must send a written request to the Director of FDA's Center for Food Safety and Applied Nutrition, including information about the country's BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other relevant information. DATES: This interim final rule is effective July 16, 2008. Submit written or electronic comments on this interim final rule by July 16, 2008. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by May 19, 2008 (see the “Paperwork Reduction Act of 1995” section of this document). ADDRESSES: You may submit comments, identified by Docket No. 2004N-0081 and RIN 0910-AF47, by any of the following methods: *Electronic Submissions* Submit electronic comments in the following ways: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. *Written Submissions* Submit written submissions in the following ways: • FAX: 301-827-6870. • Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal, as described previously in the ADDRESSES portion of this document under *Electronic Submissions* . *Instructions* : All submissions received must include the agency name and Docket No. and Regulatory Information Number
(RIN)for this rulemaking. All comments received may be posted without change to *http://www.regulations.gov* , including any personal information provided. For additional information on submitting comments, see section IV of the SUPPLEMENTARY INFORMATION section of this document. *Docket* : For access to the docket to read background documents or comments received, go to *http://www.regulations.gov* and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Rebecca Buckner, Center for Food Safety and Applied Nutrition (HFS-316), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1486. SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of July 14, 2004 (69 FR 42256), FDA issued an interim final rule entitled “Use of Materials Derived From Cattle in Human Food and Cosmetics” (“the 2004 IFR”) to address the potential risk of BSE in human food and cosmetics. In the 2004 IFR, FDA designated certain materials from cattle as “prohibited cattle materials” and banned the use of such materials in human food, including dietary supplements, and in cosmetics. These restrictions appear in §§ 189.5 and 700.27 (21 CFR 189.5 and 21 CFR 700.27) of FDA's regulations. The 2004 IFR designated the following as prohibited cattle materials: SRMs, the small intestine from all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, or MS (Beef). SRMs include the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine from all cattle. The Food Safety and Inspection Service
(FSIS)of the United States Department of Agriculture
(USDA)designated the same list of materials as SRMs in its interim final rule entitled “Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle” (69 FR 1862, January 12, 2004). In the **Federal Register** of September 7, 2005 (70 FR 53063), FDA amended the 2004 IFR to permit the use of the small intestine in human food and cosmetics provided the distal ileum portion of the small intestine has been removed. FDA also clarified that milk and milk products, hide and hide-derived products, and tallow derivatives are not prohibited cattle materials, and cited a different method for determining impurities in tallow. Also in the **Federal Register** of September 7, 2005 (70 FR 53043), FSIS published a similar amendment to its interim final rule, permitting the use of the small intestine in human food provided the distal ileum is removed. II. Amendments to the Interim Final Rule's Provisions on Prohibited Cattle Materials In the 2004 IFR, FDA requested comment on whether materials from countries believed to be free of BSE should be exempt from the “prohibited cattle materials” requirements. FDA further solicited comment on what standards it should apply in determining whether to exempt a country and how it should determine whether a country meets such standards (69 FR 42256 at 42263). FSIS requested similar comment on the issue of equivalence in applying its BSE requirements in an advance notice of proposed rulemaking
(ANPR)entitled “Federal Measures to Mitigate BSE Risks: Considerations for Further Actions,” jointly published by USDA's Animal and Plant Health Inspection Service (APHIS) and FSIS, and FDA on July 14, 2004 (69 FR 42299-42300). A. Comments Received In response to FDA's solicitation on this issue, FDA received comments from representatives of several foreign countries that export cattle materials or products derived from such materials into the United States and from several trade associations. The comments take issue with the uniform application of FDA's BSE-related measures to all human food and cosmetics imported into the United States, without regard to the BSE risk status of the originating country. Several comments state that their countries have a comprehensive range of control measures in place to prevent the entry and/or amplification of the BSE agent. These comments maintain that countries classified as BSE-free do not present a BSE risk and therefore should not be expected to comply with FDA's BSE-related restrictions. These comments further maintain that U.S. requirements are forcing establishments and firms in countries considered to be free of BSE to carry out costly and unnecessary measures that are not scientifically justified so that they can export cattle materials to the United States. These comments also state that providing an exemption from BSE-related restrictions for countries classified as free of BSE would be consistent with guidelines established by the World Organization for Animal Health (referred to as “OIE,” based on its previous name, Office International des Epizooties), an international standard-setting body with 169 member countries, that publishes health standards for international trade in animal products. These comments state that the OIE recommends that countries restrict the importation of cattle material of potential concern on the basis of the BSE risk classification of the country or zone of origin. (See Terrestrial Animal Health Code, Ref. 1). These comments also point out that OIE recommends the removal of SRMs for imports from countries classified as minimal, moderate, and high risk for BSE but not for imports from countries with BSE-free status. 1 Further, these comments point out that the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures (the SPS Agreement) requires member countries to recognize regionalization of diseases and not put in place measures that are more trade restrictive than necessary to achieve public health goals. 1 At the time the comments were submitted, OIE classified countries for purposes of BSE into one of five categories: “free,” “provisionally free,” “minimal,” “moderate,” and “high risk.” OIE subsequently revised its categories and now uses only three categories: “negligible,” “controlled,” and “undetermined” risk. Countries previously categorized as “BSE-free” or “provisionally free” are now categorized as having “negligible” BSE risk. Several of the comments also note that Canada and the European Union
(EU)do not apply all of their BSE-related restrictions to countries recognized as BSE-free. For example, EU food and cosmetic regulations exclude countries that fall within the EU's lowest risk range of BSE risk categories from restrictions on the use of SRMs. Canada provides a similar exemption from its BSE-related restrictions for countries it considers to be free from BSE. 2 2 Since these comments were submitted, Canada has adopted the OIE BSE risk categorization system of negligible, controlled, and undetermined risk. The EU is in the process of transitioning from its geographical BSE risk
(GBR)system, which includes four levels of risk, to the OIE 3-tiered risk categorization system. One comment suggests that in considering the BSE risk status of another country, FDA should refer to available country assessments already completed by USDA's APHIS in carrying out its BSE-related restrictions on imports of meat and edible products from ruminants (codified at 9 CFR 94.18), or otherwise rely on criteria provided by OIE for determining BSE-free countries. One comment recommends that if the assessment is conducted by U.S. authorities, it should be conducted by a single U.S. agency, preferably APHIS, given its prior experience in conducting this type of assessment. B. USDA Amendment USDA's FSIS received similar comments in response to its interim final rule published on January 12, 2004, and the ANPR published July 14, 2004, regarding the application of its BSE-related restrictions for imported products without taking into account a country's BSE risk status. Based in part on these comments, FSIS, in its affirmation of interim final rules with amendments published on July 13, 2007 (72 FR 38699), amended its regulations to exclude from its definition of SRMs those materials from cattle that come from foreign countries that can demonstrate that their BSE risk status can reasonably be expected to provide the same level of protection from exposure to the BSE agent as does prohibiting the use of SRMs in the United States. C. Response to Comments FDA agrees with the views expressed by the comments and has determined that it is not necessary for all BSE-related restrictions to apply to human food and cosmetics regardless of a country's BSE status. FDA's BSE-related restrictions for human food and cosmetics are intended to address the potential presence of BSE in a country's cattle population. SRMs are prohibited because they are the tissues most likely to harbor infectivity in cattle with BSE. The small intestine is prohibited unless the distal ileum portion of the small intestine, which is considered an SRM, is effectively removed. Material from nonambulatory disabled cattle are prohibited because evidence has indicated that this segment of the cattle population is more likely to have BSE than healthy-appearing cattle and the typical clinical signs of BSE having to do with gait and movement cannot be observed in nonambulatory cattle. MS
(Beef)is included in the definition because it may contain concentrated amounts of the following SRMs: spinal cord, dorsal root ganglia, and vertebral column. Material from cattle not inspected and passed is prohibited because they are at higher risk of harboring undetected BSE. As described in the 2004 IFR, epidemiological evidence indicates that the BSE epidemic in the United Kingdom (U.K.) was a result of consumption of animal feed contaminated by the BSE agent. The spread of BSE outside the U.K. has been attributed to the export of BSE-contaminated feed from the U.K. to other countries prior to the realization of the role of feed in transmitting the disease and the implementation of restrictions on such trade. However, a country may not have engaged in trade in animal feed with the U.K. or other affected countries, and it may have had preventive measures in place for a length of time adequate to make the chance remote that BSE currently is present in its national herds. Such a country may be able to demonstrate to FDA that its BSE case history, risk factors, and measures to prevent the introduction and transmission of BSE make certain BSE-related restrictions unnecessary. Not restricting cattle materials inspected and passed for human consumption from such a country to be used in human food and cosmetics is consistent with all applicable statutory standards. Further, this approach is consistent with OIE's recommendation that cattle materials from negligible risk countries not be restricted. Material from cattle not inspected and passed for human consumption will continue to be prohibited, regardless of the country of origin. We are retaining this provision as a universal requirement because the exception for designated countries in this amendment is predicated on application of a country's food safety controls, including inspection of source animals, to human food or cosmetics made with cattle materials and imported into the United States. It is critical to ensuring safety that, regardless of the country of origin, source cattle have been evaluated and determined appropriate for human consumption. In addition, applying this requirement universally is consistent with OIE recommendations, which recognize the importance that cattle pass antemortem and post-mortem inspections even in “negligible risk” countries. Therefore, FDA is amending its regulations in §§ 189.5 and 700.27 to provide that FDA may designate a country as not subject to the restrictions applicable to human food and cosmetics manufactured from, processed with, or that otherwise contain SRMs, the small intestine of cattle, material from nonambulatory disabled cattle, or MS (Beef). Cattle materials inspected and passed from a designated country will not be considered prohibited cattle materials and their use will not render a human food or cosmetic adulterated. The amendment further provides that a country seeking to be so designated must send a written request to the Director of FDA's Center for Food Safety and Applied Nutrition, including information about a country's BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and other information relevant to determining whether SRMs, the small intestine of cattle (unless the distal ileum has been removed), material from nonambulatory disabled cattle, or MS
(Beef)should be considered prohibited cattle materials. In its application, the requesting country will be expected to provide information to FDA on its BSE case history, including whether cattle in that country have tested positive for BSE, and if so, the circumstances and the country's response. In addition, FDA will review information that addresses the extent to which the requesting country has identified and taken into account relevant risk factors such as the following: • Possible presence of BSE in indigenous and/or imported cattle; • Geographic origin of imported cattle; • Materials used in the production of ruminant feed and feed ingredients; and • Importation of ruminant feed and feed ingredients. FDA will consider information relating to the possible presence of BSE in indigenous and imported cattle in the requesting country as well as the requesting country's production and importation of ruminant feed and feed ingredients. With respect to imported cattle, relevant information includes the identification of any countries where imported cattle were born or raised and the dates any cattle were imported. With regard to ruminant feed, FDA will consider, among other things, how ruminant feed was produced in the requesting country, including what animal origin materials were allowed to be included. FDA will also consider whether ruminant feed and feed ingredients were imported, and if so, the source countries and dates of import. In addition to reviewing risk factors such as those identified previously, FDA will assess how the requesting country has addressed and managed any identified BSE risks through the implementation of appropriate measures to prevent the introduction and transmission of BSE. FDA will consider how long such preventive measures have been in place and whether they have been effectively carried out. Examples of preventive measures include the following: • A prohibition on the use of ruminant feed that might carry a risk of transmitting the BSE agent; • A prohibition on the importation of cattle and cattle-derived products that might carry a risk of transmitting the BSE agent; • Surveillance systems for BSE in cattle populations with appropriate examination of brain or other tissues collected for surveillance in approved laboratories; • Mandatory notification and examination of all cattle showing signs consistent with BSE; and • Protocols or other written procedures for investigating potential cases of BSE, including ability to trace former herdmates of BSE-positive animals. As part of its evaluation of feed restrictions, FDA will consider factors including whether appropriate feed restrictions are in place and the adequacy of enforcement of those restrictions (e.g., the frequency of facility inspections and level of compliance). FDA also will consider a requesting country's import controls for cattle material. Such consideration will include whether the country effectively monitors and controls potential pathways of SRMs and other potentially infective materials into its country from other countries for whom such controls are necessary. In addition, FDA will consider the requesting country's surveillance and monitoring efforts with respect to BSE. For example, FDA will evaluate the level at which the country performs surveillance and monitoring, whether tissue samples are collected and examined at approved laboratories, and whether recognized diagnostic procedures and methods are used, such as those procedures and methods provided in the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (Ref. 2). FDA also will consider whether the country has an ongoing program for notification and investigation of all cattle showing signs consistent with BSE. In evaluating such a program, FDA will consider, among other factors, whether notification and investigation are mandated, whether veterinarians, producers, and others involved in cattle production have been provided sufficient information about BSE, such as through an awareness program, and whether there are additional measures in place to stimulate reporting of suspect cattle, such as compensation or penalties. FDA also will consider a country's written procedures for investigating potential cases of BSE. Such a consideration will include whether the country has written procedures for the investigation of suspect animals and whether the country has the investigative capability to followup positive findings by tracing former herdmates of animals determined to be BSE positive. Finally, FDA also will consider any other information relevant to determining whether the country should be designated under §§ 189.5(e) and 700.27(e). FDA and the USDA agencies, APHIS and FSIS, have different regulatory responsibilities with respect to preventing BSE and ensuring food safety. Further, it is not necessary or practical for one of the three agencies to conduct every evaluation of a country's BSE status, regardless of the purpose of the evaluation. FDA will, however, consult with APHIS and FSIS as part of its evaluation process. Further, FDA will take into consideration available risk assessments of other competent authorities in conducting its evaluation. Though it is not required, a previous BSE evaluation by USDA, OIE, or by another country or another competent authority, will be helpful to FDA in its review and may decrease the time needed for FDA to make a determination. Upon completion of its review, FDA will provide written notification of its decision to the applicant country, including the basis for the decision. FDA may impose conditions in granting a request for designation. Further, any designation granted under § 189.5 or § 700.27 will be subject to future review by FDA to ensure that the designation remains appropriate. As part of this process, FDA may ask designated countries to confirm that their BSE situation and the information submitted by them in support of their original application remain unchanged. Further, FDA may revoke a country's designation if FDA determines that it is no longer appropriate. FDA will provide further information on its evaluation process, the scope of the review, and the types of supporting information that it would find helpful in reviewing a country's submission at the time of the request. III. Summary of Amendments to the Interim Final Rule FDA is amending its regulations in §§ 189.5(a) and 700.27(a) by revising the definition of “prohibited cattle materials” to exclude cattle materials inspected and passed for human consumption from a country designated by FDA under § 189.5(e) or § 700.27(e). New §§ 189.5(e) and 700.27(e) provide that a country seeking such a designation must send a written request to the Director, Office of the Center Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835. Further, the request shall include information about a country's BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and other information relevant to determining whether SRMs, the small intestine of cattle (unless the distal ileum has been removed), material from nonambulatory disabled cattle, or MS
(Beef)should be considered prohibited cattle materials. The new sections further provide that FDA shall respond in writing to any such request and that FDA may revoke a country's designation if FDA determines that it is no longer appropriate. IV. Effective Date and Opportunity for Public Comment In the 2004 IFR, FDA solicited comment on whether materials from countries believed to be free from BSE should be exempt from the “prohibited cattle materials” requirements. FDA addresses the comments it received in this document. This amendment is effective on July 16, 2008. FDA invites public comment on the current amendment to the interim final rule; submit written or electronic comments on the interim final rule by July 16, 2008. The agency will consider modifications to the current amendment to the interim final rule based on comments made during the comment period. Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA through FDMS only. FDA will address other comments received in response to the 2004 IFR and comments received in response to this document in further rulemaking. V. Executive Order 12866 and Regulatory Flexibility Act A. Interim Final Regulatory Impact Analysis FDA has examined the economic impacts of the interim final rule under Executive Order 12866. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 12866 classifies a rule as significant if it meets any one of a number of specified conditions, including having an annual effect on the economy in a material way, adversely affecting competition, or adversely affecting jobs. A regulation is also considered a significant regulatory action if it raises novel legal or policy issues. FDA has determined that this interim final rule is not a significant regulatory action as defined by Executive Order 12866. 1. Need for Regulation FDA agrees with FSIS and the international community that cattle materials imported from countries that can demonstrate that their BSE case history and their having in place effective measures to prevent the introduction and transmission of BSE may be such that they should not be subject to the same BSE-related restrictions applied to cattle materials imported into the United States from other countries. Restricting the importation of potentially infective materials on the basis of the BSE risk of the region of origin is more efficient than an approach that does not consider a country's circumstances regarding BSE. As comments on the 2004 IFR have noted, the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures (the SPS Agreement) requires member countries to recognize regionalization of diseases and not put in place measures that are more trade restrictive than necessary to achieve public health goals. Thus, the uniform application by FDA of BSE-related restrictions to all imports of food and cosmetic products into the United States without taking into account a country's BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and other relevant information means that other countries must implement costly and unnecessary measures that may not be scientifically justified. Providing this exception from certain requirements relating to human food and cosmetics for designated countries is more efficient in the sense that it achieves essentially the same protection of public health with fewer restrictions on the market for cattle-derived materials. 2. Interim Final Rule Coverage Foreign countries need to make formal application to FDA in order to be considered for this exception from the provision on prohibited cattle materials in §§ 189.5 and 700.27. FDA will make a determination as to a country's request based on an evaluation that is carried out in consultation with the USDA's APHIS and FSIS. FDA will take into consideration relevant technical information provided by the requesting country with respect to its BSE case history, including whether cattle in that country have tested positive for BSE, and if so, the circumstance and the country's response. In addition, FDA will review information that addresses the extent to which the requesting country has identified and taken into account relevant risk factors such as the following: • The possible presence of BSE in indigenous and/or imported cattle; • Geographic origin of imported cattle; • Materials used in the production of ruminant feed and feed ingredients; and • Importation of ruminant feed and feed ingredients. FDA will also assess how the requesting country has addressed and managed any identified BSE risks through the implementation of appropriate measures to prevent the introduction and transmission of BSE, such as the following: • A prohibition on the use of ruminant feed that might carry a risk of transmitting the BSE agent; • A prohibition on the importation of cattle and cattle-derived products that might carry a risk of transmitting the BSE agent; • Surveillance systems for BSE in cattle populations with appropriate examination of brain or other tissues collected for surveillance in approved laboratories; • Mandatory notification and examination of all cattle showing signs consistent with BSE; and • Protocol or other written procedures for investigating potential cases of BSE, including ability to trace former herdmates of BSE-positive animals. *Number of Countries Affected* We do not know how many countries will take advantage of the option to petition FDA for a designation under §§ 189.5(e) and 700.27(e). According to information from the OIE, countries that are officially recognized as having a “negligible BSE risk” in accordance with the requirements of the OIE Terrestrial Animal Health Code (16th edition 2007) include the following: Australia, Argentina, New Zealand, Singapore, and Uruguay. Two countries, Iceland and Paraguay, are recognized as “provisionally free” 3 from BSE. For these two categories of countries, OIE does not recommend the removal of SRMs (Ref. 4). 3 The OIE “provisionally free” designation is in accordance with the 2004 edition (13th edition) of the Terrestrial Animal Health Code, and remains in effect for Iceland and Paraguay until May 2008. See Ref. 3. Table 1 presents data from the U.S. International Trade Commission (Ref. 5) showing for 2006 the top 10 exporters of meat products 4 and animal fats, oils, and by-products to the United States. 4 The data sorted by NAICS code does not allow for the separation of beef products that are imported from other imported meat products such as pork. **Table 1.—Top 10 Countries Exporting Specified North American Industry Classification System (NAICS) Code Products to United States for 2006** NAICS 311611 1 —Meat Products (Excluding Poultry) Quantity (thousands of kilograms) 2 Canada 681,899 Australia 376,585 New Zealand 211,873 Uruguay 103,305 Brazil 83,897 Denmark 46,652 Mexico 35,553 China 28,530 Argentina 22,353 Nicaragua 21,303 NAIC 311613—Animal Fats, Oils, & By-Products (thousands of kilograms) 3 Canada 94,306 New Zealand 32,550 China 7,809 Australia 6,807 Brazil 6,589 Mexico 2,130 Colombia 1,826 Germany 1,642 Ecuador 1,149 Japan 1,138 1 The NAIC code 31161 covers the animal slaughtering and processing industry. The industry is composed of establishments that are primarily engaged in one or more of the following:
(1)Slaughtering animals,
(2)preparing processed meats and meat by-products, and
(3)rendering and refining animal fat, bones, and meat scraps. The subcategory 311611 comprises those establishments primarily engaged in slaughtering animals (except poultry and small game). Establishments that slaughter and prepare meats are included in this classification. (Ref. 5) We use this data as an indicator of the countries that are most likely to petition FDA regarding their BSE status. 2 These figures do not include exports measured in “clean yield kilograms” and “pieces.” 3 These figures do not include exports measured in “grams,” “liters,” “metric tons,” and “pieces.” We do not know how many countries might petition the FDA. However, taking into consideration the previous information on countries officially recognized as having a negligible BSE risk or being provisionally free of BSE under OIE, as well as the information in table 1 on countries that export large amounts of meat products and animal fats, oils, and byproducts to the United States, we are estimating for this analysis that 10 countries may be interested in petitioning FDA to be excepted from certain BSE-related restrictions applicable to human food and cosmetics. Our estimate is not intended to suggest that all of these countries would be able to qualify for a designation under §§ 189.5(e) and 700.27(e). 3. Costs and Benefits of Exemption Provision Countries that petition the FDA to be designated as excepted from certain BSE-related restrictions applicable to human food and cosmetics may also petition USDA for exclusion from USDA's BSE-related requirements. Some of the costs to countries to petition FDA may be shared with costs to petition USDA because of similarities regarding how countries' products can qualify for the exceptions. Even so, we will outline here a potential scenario for calculating the costs of petitioning FDA for an exception from certain provisions of the agency's BSE regulations. a. *Assumptions and costs associated with this interim final rule.* We would expect countries that wish to petition FDA to be excepted from certain BSE-related restrictions applicable to human food and cosmetics to have already completed a risk assessment and put risk management strategies into place. 5 Whether these risk assessment and mitigation strategies are sufficient for a country to be so designated by FDA will be determined on a case-by-case basis. 5 We assume such measures were necessary to continue marketing cattle products following the surge of BSE cases in the U.K. and the rulemakings that followed. b. *Petition process.* We assume petitions to FDA for this designation would include an already developed risk assessment or other technical information on the country's BSE situation, a detailed outline of risk mitigation strategies, and information on the country's cattle-derived products that are exported to the United States. The petition is assumed to take 80 hours per country for assembly of the information and the wage for a government employee earning a GS-14 step 1 (Ref. 6) is used to estimate the costs. The cost of assembling a single petition is estimated to be about $5,400 (80 hours x $67.44 per hour including overhead). The petition will also be reviewed by higher level government managers before being sent to the FDA. We assume the wage for a high level government executive is a GS-15 step 3 (Ref. 6) and that they will spend 40 hours reviewing the petition. The cost of review by a government manager is estimated to be about $3,400 (40 hours x $84.62 per hour including overhead). Thus, the total cost to each country to prepare and submit a petition to FDA to be considered for this designation would be about $9,000. c. *Petition review by FDA* . It will take FDA approximately 80 hours to review a petition. The cost of each petition review would be about $3,700 (80 hours x $45.65 per hour). 6 6 Pay for an employee earning a GS-13 step 7 adjusted to include locality pay for Washington D.C. and surrounding area (Ref. 6). **Table 2.—Total Cost of Initial Petition Application and Review** Petition Assembly and Review per Country $9,000 FDA Review per Petition $3,700 Total Cost per Country $12,700 Cost for 10 Countries $127,000 d. *Petition success uncertainty.* It is possible that some countries that petition the FDA to be designated as excepted from certain BSE-related restrictions applicable to human food and cosmetics will not be successful. We do not know how likely it will be that countries with insufficient BSE risk assessment and mitigation strategies will petition the FDA. e. *Future petitions to FDA* . It is likely that those countries that currently sell a significant amount of cattle-derived material will be most interested in seeking possible relief under this change to FDA's prohibited cattle materials requirements. It is possible in the future, if new markets for cattle derived products develop, that other countries may want to petition FDA to be designated as not subject to certain BSE-related restrictions applicable to human food and cosmetics. We do not attempt to forecast new markets for cattle derived products here. We also do not attempt to forecast the frequency of, or estimate the costs associated with, FDA review in the future of successful petitions. f. *Future review of successful petitions by FDA.* Countries that successfully petition the FDA to be designated as excepted from certain BSE-related restrictions applicable to human food and cosmetics will be subject to future review by FDA to ensure that their designation remains appropriate. As part of this process, FDA may ask designated countries to confirm that their BSE situation and the information submitted by them in support of their original application remain unchanged. FDA may revoke a country's designation if FDA determines that it is no longer appropriate. FDA has not yet determined the method by which the agency will conduct these future reviews. One possible method would be for FDA to send a letter to designated countries asking whether there has been a change in their status or circumstances relative to their BSE history, surveillance, import activities, or other relevant criteria and then compare any changed information with the information that was originally submitted. The OIE requires that countries it has recognized in regard to their BSE status “should annually confirm during the month of November whether their status and the criteria by which their status was recognized have remained unchanged.” In some cases, the FDA reviewer might rely on this information, if available, in conducting a future review of the country's designation. We assume it will take FDA and the designated country undergoing a review in the future about one third the time and effort it did when the original information was submitted. Thus, if the total cost to initially submit a petition and have it reviewed by FDA was $12,700, then a future review of the petition by FDA and the submitting country will cost about $4,200 (see Table 3). **Table 3.—Cost of Future Review of Successful Petitions** Submission of Additional Information and Response by Country $3,000 FDA Review per Country $1,200 Total Cost per Country $4,200 Cost for 10 Countries $42,000 4. Other Options Considered FDA considered the following options when examining the costs and benefits of this IFR. *Option 1* —Do nothing. This option is the baseline for which the costs and benefits of other options are compared. The costs and benefits of this option have already been realized. Firms buying and selling cattle-derived materials in the United States and other countries have found alternatives to using products covered by the definition of prohibited cattle materials in the manufacture of their products. *Option 2* —Amend definition of prohibited cattle materials (the chosen option). The costs and benefits of this option are outlined previously. The main benefit of this option is that it is more efficient than the current regulation because it achieves essentially the same protection of public health with fewer restrictions on the market for cattle-derived materials. With this interim final rule, FDA can continue to prevent the potential introduction and transmission of BSE from cattle materials from non-designated countries, while at the same time reducing the restrictions on the market for cattle-derived materials from designated countries. *Option 3* —Amend the definition of prohibited cattle materials to allow material from cattle not inspected and passed for human consumption for use in human food and cosmetics. This option is less stringent than option 2, which would reduce the costs of cattle-derived materials used in the manufacture of human food and cosmetics, but it would not provide the same public health benefits as options 1 and 2. Material from cattle not inspected and passed for human consumption has not been approved by a regulatory authority (USDA or other) and thus we cannot make the determination that, among other things, the cattle material is from an animal that was evaluated for a neurological disorder such as BSE. In requiring that material from cattle for use in FDA-regulated human food and cosmetics be inspected and passed for human consumption, we are minimizing the risk of exposure to the agent that causes BSE, and therefore maximizing the protection of public health from variant Creutzfeldt-Jakob disease, the human disease linked to consumption of BSE-infected cattle material. 5. Benefits Under this interim final rule, foreign countries would have the option of demonstrating (through information submitted to FDA) that their BSE case history, their identifying and taking into account relevant risk factors, their implementing appropriate measures to prevent the introduction and transmission of BSE, and any other relevant information shows that certain BSE-related restrictions, in their case, are unnecessary. Countries that successfully petition FDA would be able to again export human food and cosmetics to the United States without the removal of the following items: • SRMs • Small intestine (including the distal ileum) • Material from nonambulatory disabled cattle • MS
(Beef)6. Effect on Food Supply in the United States We expect this interim final rule amendment will increase the availability of certain cattle materials (and products containing those materials) for sale in the United States. The most significant gain in supply will probably occur from the increased availability of FDA-regulated products that contain MS
(Beef)and material from nonambulatory disabled cattle for use in human food regulated by FDA. Few, if any, human food or cosmetic products use SRMs as an ingredient, but to the extent that these materials are needed, they will again be available in the United States. B. Final Regulatory Flexibility Analysis The Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* )
(RFA)imposes certain requirements with respect to Federal rules that are subject to the notice and comment requirements of section 553(b) of the Administrative Procedure Act (5 U.S.C. 551 *et seq.* ) and that are likely to have a significant economic impact on a substantial number of small entities. Unless an agency certifies that a proposed rule will not have a significant economic impact on a substantial number of small entities, section 603 of the RFA requires that the agency present an initial regulatory flexibility analysis at the time of the publication of the notice of proposed rulemaking describing the impact of the rule on small entities and seeking public comment on such impact. Because this rule is being issued as an interim final rule, the RFA does not apply and FDA is not required to either certify that the rule will not have a significant impact on a substantial number of small businesses or conduct an initial regulatory flexibility analysis. Also, FDA does not have information on how many small firms in foreign countries designated by the agency may benefit from this rule. Examining the effect this interim final rule has on small foreign firms is outside the scope of the RFA requirements. The extent to which small firms within the United States are affected by this rule is unknown. FDA acknowledges that small U.S. businesses that use imported cattle materials in manufacture or for sale as final products will likely benefit from this rulemaking as costs of these inputs are expected to decrease as supply increases. Small U.S. firms that compete with foreign firms in order to supply cattle-derived inputs and products to U.S. business and markets may be adversely affected if foreign firms can more cheaply supply these materials and products. FDA seeks public comment on the question of whether such small U.S. businesses will be adversely impacted by this rule. C. Unfunded Mandates Title II of the Unfunded Mandates Reform Act of 1995 (Public Law 104-4) requires cost-benefit and other analyses before any rule making if the rule would include a “Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $127 million, using the most current
(2006)Implicit Price Deflator for the Gross Domestic Product. FDA has determined that this interim final rule does not constitute a significant rule under the Unfunded Mandates Reform Act. VI. Paperwork Reduction Act of 1995 This interim final rule contains information collection requirements that are subject to review by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, description, and respondent description of these provisions are shown in the following paragraphs with an estimate of the annual recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information. FDA invites comments on:
(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;
(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. *Title* : Petition To Be Designated as Not Subject to Certain BSE-Related Restrictions Applicable to FDA Regulated Human Food and Cosmetics *Description* : FDA is amending the interim final rule on use of materials derived from cattle in human food and cosmetics published in the **Federal Register** of July 14, 2004, and then amended on September 7, 2005. In the 2004 interim final rule and its amendments, FDA designated certain materials from cattle as “prohibited cattle materials” and banned the use of such materials in human food, including dietary supplements, and in cosmetics. Prohibited cattle materials include SRMs, the small intestine of all cattle unless the distal portion of the ileum is removed, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and MS (Beef). SRMs include the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal ileum of the small intestine of all cattle. Therefore, FDA is amending its regulations at §§ 189.5 and 700.27 to provide that FDA may designate a country as not subject to the restrictions applicable to human food and cosmetics manufactured from, processed with, or that otherwise contain SRMs, the small intestine of cattle, material from nonambulatory disabled cattle, or MS (Beef). The interim final rule, as amended, provides that these materials, when from cattle from a designated country, are not considered prohibited cattle materials, and their use does not render a human food or cosmetic adulterated. The amendment further provides that a country seeking to be so designated must send a written request to the Director of FDA's Center for Food Safety and Applied Nutrition, including information about a country's BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and other information relevant to determining whether SRMs, the small intestine of cattle (unless the distal ileum has been removed), material from nonambulatory disabled cattle, or MS
(Beef)should be considered prohibited cattle materials. *Description of Respondents* : Countries with firms that would like to use SRMs, the small intestine of cattle, material from nonambulatory disabled cattle, or MS
(Beef)in products exported to the United States. *Information Collection Burden Estimate* FDA estimates the burden for this information collection as follows: **Table 4.—Estimated One-Time and Recurring Reporting Burden** 1 21 CFR Section No. of Respondents No. of Responses per Respondent Total Annual Responses Hours per Response Total Hours 189.5 and 700.27 2 10 1 10 80 800 189.5(e) and 700.27(e) 10 1 10 26.4 264 Total one time burden 800 Total recurring burden 264 1 There are no capital costs or operating and maintenance costs associated with the collection of information under this interim final rule. 2 One-time burden. *One Time Reporting Burden* There will be a one time burden to countries that apply to FDA seeking to be designated as not subject to restrictions applicable to SRMs, the small intestine of cattle, nonambulatory disabled cattle, or MS (Beef). We estimate that each country that applies for an exclusion will spend 80 hours putting information together to submit to FDA. Table 4 row 3 of this document presents the one-time burden expected for countries who apply for the exclusion. *Recurring Burden* Countries that successfully petition the FDA to be designated as excepted from certain BSE-related restrictions applicable to human food and cosmetics will be subject to future review by FDA to ensure that their designation remains appropriate. As part of this process, FDA may ask designated countries from time to time to confirm that their BSE situation and the information submitted by them in support of their original application remain unchanged. We assume it will take FDA and the designated country undergoing a review in the future about one third the time and effort it did when the information was submitted. Table 4 row 4 of this document presents the expected recurring burden. The information collection provisions of this interim final rule have been submitted to OMB for review. Interested persons are requested to fax comments regarding information collection by (see DATES ), to the Office of Information and Regulatory Affairs, OMB. To ensure that comments on information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. Prior to the effective date of this interim final rule, FDA will publish a notice in the **Federal Register** announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this interim final rule. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. VII. Environmental Impact Analysis The agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. VIII. Federalism FDA has analyzed this interim final rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive Order requires agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” FDA has determined that the interim final rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the interim final rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. IX. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the **Federal Register** .) 1. World Organization for Animal Health, Terrestrial Animal Health Code (2007), Chapter 2.3.13, Bovine Spongiform Encephalopathy. See also Appendix 3.8.4 (Surveillance for Bovine Spongiform Encephalopathy) and Appendix 3.8.5 (Factors to Consider in Conducting the Bovine Spongiform Encephalopathy Risk Assessment Recommended in Chapter 2.3.13). Accessed online at *http://www.oie.int/eng/normes/mcode/en_sommaire.htm* . 2. World Organization for Animal Health, Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 2004 (updated 2006). Accessed online at *http://www.oie.int/eng/normes/mmanual/A_summry.htm* . 3. World Organization for Animal Health (OIE), Recognition of the Bovine Spongiform Encephalopathy Status of Member Countries, OIE Resolution No. XXIV, adopted by the International Committee of the OIE on May 22, 2007. See *http://www.oie.int/eng/info/en_statesb.htm?eld6* , accessed August 30, 2007. 4. United States International Trade Commission, Interactive Tariff and Trade Dataweb, *http://dataweb.usitc.gov/* , accessed April 6, 2007. 5. NAICS Association, *http://www.naics.com/censusfiles/NDEF311.HTM* , accessed August 27, 2007. 6. U.S Office of Personnel Management Salaries and Wages 2007 General Schedule, *http://www.opm.gov/oca/07tables/indexGS.asp* , accessed on April 11, 2007. List of Subjects 21 CFR Part 189 Food additives, Food packaging. 21 CFR Part 700 Cosmetics, Packaging and containers. Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 189 and 700 are amended as follows: PART 189—SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD 1. The authority citation for 21 CFR part 189 continues to read as follows: Authority: 21 U.S.C. 321, 342, 348, 371, 381. 2. Section 189.5 is amended by revising paragraph (a)(1) and by adding paragraph
(e)to read as follows: § 189.5 Prohibited cattle materials.
(a)* * *
(1)Prohibited cattle materials means specified risk materials, small intestine of all cattle except as provided in paragraph (b)(2) of this section, material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated
(MS)(Beef). Prohibited cattle materials do not include the following:
(i)Tallow that contains no more than 0.15 percent insoluble impurities, tallow derivatives, hides and hide-derived products, and milk and milk products, and
(ii)Cattle materials inspected and passed from a country designated under paragraph
(e)of this section.
(e)*Process for designating countries* . A country seeking designation must send a written request to the Director, Office of the Center Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration, at the address designated in 21 CFR 5.1100. The request shall include information about a country's bovine spongiform encephalopathy
(BSE)case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other information relevant to determining whether specified risk materials, the small intestine of cattle except as provided in paragraph (b)(2) of this section, material from nonambulatory disabled cattle, or MS
(Beef)from cattle from the country should be considered prohibited cattle materials. FDA shall respond in writing to any such request and may impose conditions in granting any such request. A country designation granted by FDA under this paragraph will be subject to future review by FDA, and may be revoked if FDA determines that it is no longer appropriate. PART 700—GENERAL 3. The authority citation for 21 CFR part 700 continues to read as follows: Authority: 21 U.S.C. 321, 331, 352, 355, 361, 362, 371, 374. 4. Section 700.27 is amended by revising paragraph (a)(1) and by adding paragraph
(e)to read as follows: § 700.27 Use of prohibited cattle materials in cosmetic products.
(a)* * *
(1)Prohibited cattle materials means specified risk materials, small intestine of all cattle except as provided in paragraph (b)(2) of this section, material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated
(MS)(Beef). Prohibited cattle materials do not include the following:
(i)Tallow that contains no more than 0.15 percent insoluble impurities, tallow derivatives, hides and hide-derived products, and milk and milk products, and
(ii)Cattle materials inspected and passed from a country designated under paragraph
(e)of this section.
(e)*Process for designating countries* . A country seeking designation must send a written request to the Director, Office of the Center Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration, at the address designated in 21 CFR 5.1100. The request shall include information about a country's bovine spongiform encephalopathy
(BSE)case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other information relevant to determining whether specified risk materials, the small intestine of cattle except as provided in paragraph (b)(2) of this section, material from nonambulatory disabled cattle, or MS
(Beef)from cattle from the country should be considered prohibited cattle materials. FDA shall respond in writing to any such request and may impose conditions in granting any such request. A country designation granted by FDA under this paragraph will be subject to future review by FDA, and may be revoked if FDA determines that it is no longer appropriate. Dated: April 11, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. 08-1142 Filed 4-15-08; 8:45 am]
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Traces to 25 documents
11 references not yet in our index
  • 12 CFR 218
  • 17 CFR 247
  • 14 CFR 71
  • 19 CFR 163
  • 19 CFR 12
  • 19 CFR 113
  • 9 CFR 94.18
  • Pub. L. 104-4
  • 44 USC 3501-3520
  • 21 CFR 189
  • 21 CFR 700
Citation graph
cites case law
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Final rule; technical amendments
C.F.R.§ 218.781
C.F.R.§ 247.100
U.S.C.§ 80a–5
U.S.C.§ 553
U.S.C.§ 601
U.S.C.§ 804
U.S.C.§ 3501
U.S.C.§ 78c
C.F.R.§ 71.1
Cite12 CFR 218
Cite17 CFR 247
Cite14 CFR 71
Cites 36 · showing 12Cited by 0 across 0 sources
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