Unknown. Affirmation of interim rule as final rule

3,657 words·~17 min read·/register/2004/10/04/04-22221·

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--- schema: federal-register doc_type: fedreg source_file: FR-2004-10-04.xml --- 69 191 Monday, October 4, 2004 Contents Agricultural Agricultural Marketing Service RULES Mango promotion, research, and information order, 59120-59128 04-21622 Agriculture Agriculture Department See Agricultural Marketing Service See Animal and Plant Health Inspection Service See Forest Service See Rural Business-Cooperative Service Animal Animal and Plant Health Inspection Service RULES Plant related quarantine; domestic:

Gypsy moth, 59119-59120 04-22221 NOTICES Agency information collection activities; proposals, submissions, and approvals, E4-2470 59178-59180 E4-2474 Environmental statements; availability, etc.: Mile-a-minute weed control; permit to release nonindigenous weevil, 59180 E4-2473 Nonregulated status determinations— Monsanto Co.; genetically engineered glyphosate-tolerant cotton, 59181-59182 E4-2471 Old World climbing fern; nonindigenous moth release for biological control, 59182-59183 E4-2472 Antitrust Antitrust Division NOTICES National cooperative research notifications:

American Society for Blood and Marrow Transplantation, 59267 04-22157 Cable Television Laboratories, Inc., 59267-59268 04-22164 Ethernet in the First Mile Alliance, 59268 04-22165 Gaming Standards Association, 59268 04-22159 International Cooperation for the Integration of Processes in Pre-press, Press, and Postpress, 59268-59269 04-22154 NACE International, 59269 04-22155 National Biodiesel Accreditation Commission, 59269 04-22153 National Center for Manufacturing Sciences, Inc., 59269 04-22163 National Fluid Power Association, 59270 04-22156 Portland Cement Association, 59270 04-22162 PXI Systems Alliance, Inc., 59270-59271 04-22166 Sheet Metal and Air Conditioning Contractors’ National Association, 59271 04-22161 Society for Biomolecular Screening, Inc., 59271 04-22158 Tree Care Industry Association, 59271-59272 04-22160 Blind Blind or Severely Disabled, Committee for Purchase From People Who Are See Committee for Purchase From People Who Are Blind or Severely Disabled Census Census Bureau NOTICES Confidential Information Protection and Statistical Efficiency Act:

Business data sharing for statistical puposes, data access and confidentiality, 59186-59187 04-22216 Centers Centers for Disease Control and Prevention RULES Quarantine, inspection, and licensing: Foreign quarantine— Embargo of birds (Class: Aves) from specified Southeast Asian countries, 59144-59145 04-22258 NOTICES Grants and cooperative agreements; availability, etc.: Minority Communities; National Diabetes Education Program, 59231-59237 04-22259 Reports and guidance documents; availability, etc.:

Diseases transmitted through food supply; annual list, 59237-59238 04-22260 Civil Civil Rights Commission NOTICES Meetings; State advisory committees: Various States, 59186 04-22270 Meetings; Sunshine Act, 59186 04-22301 Coast Guard Coast Guard RULES Drawbridge operations: Connecticut, 04-22272 59135-59136 04-22273 Massachusetts, 59135 04-22274 04-22275 Ports and waterways safety: Suisun Bay, Concord, CA; security zone, 59136-59139 04-22271 Commerce Commerce Department See Census Bureau See Industry and Security Bureau See International Trade Administration See National Oceanic and Atmospheric Administration Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Agency information collection activities; proposals, submissions, and approvals, 59185-59186 04-22179 CITA Committee for the Implementation of Textile Agreements NOTICES Cotton, wool, and man-made textiles:

Hong Kong, 59206-59207 E4-2475 Indonesia, 59207-59208 E4-2466 Defense Defense Department NOTICES Arms sales notification; transmittal letter, etc., 59208-59212 04-22175 Civilian health and medical program of uniformed services (CHAMPUS): TRICARE program— Diagnosis related group updates (2005 FY), 59212-59214 04-22169 Meetings: President's Information Technology Advisory Committee, 59214 04-22173 Science Board task forces, 04-22171 59214-59215 04-22172 Senior Executive Service:

Performance Review Board; membership, 59215 04-22174 Travel per diem rates, civilian personnel; changes, 59215-59219 04-22170 Energy Energy Department See Federal Energy Regulatory Commission EPA Environmental Protection Agency RULES Hazardous waste program authorizations: Nebraska, 59139-59144 04-22252 PROPOSED RULES Hazardous waste program authorizations: Nebraska, 59165 04-22253 Solid wastes: Hazardous waste identification and listing— Exclusions, 59156-59165 04-22235 NOTICES Agency information collection activities; proposals, submissions, and approvals, 59223-59224 04-22255 Meetings:

Lead and Copper Rule; public education and risk communication; expert panel workshop, 59224 04-22238 Pesticide Program Dialogue Committee and Endangered Species Workshop, 59224-59225 04-22236 State and Tribal Toxics Action Forum, 59225-59226 04-22237 Reports and guidance documents; availability, etc.: Scientific issues in the risk assessment of metals, 59226-59227 04-22254 Executive Executive Office of the President See Presidential Documents NOTICES Meetings: Intelligence Capabilities of the United States Regarding Weapons of Mass Destruction Commission, 59227 04-22218 FAA Federal Aviation Administration RULES Class D and E airspace; correction, 59303 C4-21529 Class E airspace, 59129-59130 04-22278 Class E airspace; correction, 59303 C4-21528 Procedural rules:

Investigative and enforcement procedures; civil penalty assessment procedures, 59489-59498 04-22276 PROPOSED RULES Airworthiness directives: Airbus, 59153-59156 04-22267 Boeing, 59151-59153 04-22268 Gulfstream Aerospace, 59147-59148 04-22193 Rolls-Royce Deutschland, 59148-59151 04-22192 NOTICES Meetings: Commercial Space Transportation Advisory Committee, 59299-59300 04-22277 FCC Federal Communications Commission RULES Common carrier services: Federal-State Joint Board on Universal Service— Schools and libraries; universal service support mechanism; correction, 59145 04-22228 Satellite communications— Multichannel video distribution and data service in 12 GHz band; technical, service, and licensing rules; correction, 59145-59146 04-22226 Television broadcasting:

Digital television conversion— Transition issues, 59499-59536 04-22189 PROPOSED RULES Radio services, special: Fixed microwave services— 37.0-38.6 GHz and 38.6-40.0 GHz bands; competitive bidding, 59166 04-22194 NOTICES Agency information collection activities; proposals, submissions, and approvals, 59227-59229 04-22227 Federal Energy Federal Energy Regulatory Commission NOTICES Meetings; Sunshine Act, 59219-59222 04-22385 Federal Highway Federal Highway Administration NOTICES Environmental statements; availability, etc.:

Etowah County, AL, 59300 04-22181 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies: Formations, acquisitions, and mergers, 59229 04-22178 Permissible nonbanking activities, 59229-59230 04-22177 Federal Open Market Committee: Domestic policy directives, 59230 04-22208 Fish Fish and Wildlife Service NOTICES Comprehensive conservation plans; availability, etc.: Fish Springs National Wildlife Refuge, UT, 59263 04-22262 Endangered and threatened species:

Survival enhancement permits— Greater Adams cave beetle and lesser Adams cave beetle, 59263-59264 04-22261 Food Food and Drug Administration RULES Animal drugs, feeds, and related products: Ivermectin paste, 59131-59132 04-22182 Medical devices: Orthopedic devices— Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prothesis; premarket approval procedure, 59132-59134 04-22210 NOTICES Meetings: Pharmaceutical Science Advisory Committee, 59238-59239 04-22214 Reports and guidance documents; availability, etc.:

Combination products; current good manufacturing practices, 59239 04-22205 Computerized systems used in clinical trials, 59239-59240 04-22204 FDA Modernization Act of 1997— Recognized Standards List modification (Recognition List Number: 011), 59240-59250 04-22183 Inspection by Accedited Persons Program; implementation under Medical Device User Fee and Modernization Act of 2002; accreditation criteria, 59250-59255 04-22211 Pharmaceutical current good manufacturing practice regulations; quality systems approach, 59256 04-22206 Process analytical technology; innovative pharmaceutical development, manufacturing, and quality assurance; framework, 59257-59258 04-22203 Sterile drug products produced by aseptic processing; current good manufacturing practice, 59258-59259 04-22207 Vaccine labeling requirements for warnings, use instructions and precautionary information, 59259 04-22213 Forest Forest Service NOTICES Environmental statements; notice of intent:

Payette National Forest, ID, 59183-59184 04-22190 Meetings: Land Between The Lakes Advisory Board, 59184 04-22256 Resource Advisory Committees— Southwest Idaho, 59184-59185 04-22257 GSA General Services Administration NOTICES Reports and guidance documents; availability, etc.: Industry Day; FAI/DAU training plans and requirements for vendors, 59230 04-22242 Geological Geological Survey NOTICES Agency information collection activities; proposals, submissions, and approvals, 59264-59265 04-22180 Government Government Ethics Office NOTICES Senior Executive Service:

Performance Review Board; membership, 59230-59231 04-22209 Health Health and Human Services Department See Centers for Disease Control and Prevention See Food and Drug Administration See Health Resources and Services Administration See National Institutes of Health See Substance Abuse and Mental Health Services Administration Health Health Resources and Services Administration NOTICES Meetings: Children's Hospitals Graduate Medical Education Payment Program; conference call, 59259-59260 04-22282 Infant Mortality Advisory Committee, 59260 04-22283 Primary Care Medicine and Dentistry Training Advisory Committee, 59260-59261 04-22184 Homeland Homeland Security Department See Coast Guard Housing Housing and Urban Development Department NOTICES Federal National Mortgage Association (Fannie Mae) and Federal Home Loan Mortgage Corporation (Freddie Mac):

Government sponsored enterprises mortgage data and annual housing activities report information; proprietary information/public use data, 59475-59488 04-22049 Indian Indian Affairs Bureau NOTICES Agency information collection activities; proposals, submissions, and approvals, 59265 04-22229 Industry Industry and Security Bureau RULES Export administration regulations: Entity list— India; entity removed and license review policy revised; clarification; correction, 59303 C4-21837 Interior Interior Department See Fish and Wildlife Service See Geological Survey See Indian Affairs Bureau See Reclamation Bureau International International Trade Administration NOTICES Antidumping:

Honey from— Argentina, 59187 E4-2477 Magnesium metal from— China, 59187-59197 E4-2478 Russian Federation, 59197-59204 E4-2479 Polyvinyl alcohol from— Taiwan, 59204-59206 E4-2476 Justice Justice Department See Antitrust Division Labor Labor Department See Occupational Safety and Health Administration Legal Legal Services Corporation NOTICES Grant and cooperative agreement awards: Civil legal services to low-income clients— Various states, 59272-59276 04-22185 Morris Morris K. Udall Scholarship and Excellence in National Environmental Policy Foundation NOTICES Committees; establishment, renewal, termination, etc.:

National Environmental Conflict Resolution Advisory Committee, 59276 04-22191 NASA National Aeronautics and Space Administration NOTICES Meetings: Aerospace Safety Advisory Panel, 59276 04-22269 National Highway National Highway Traffic Safety Administration RULES Motor vehicle safety standards: Child restraint systems— Improved test dummies, update test procedures, and extended child restraints standards for children up to 65 pounds; correction, 59146 04-22279 NOTICES Motor vehicle defect proceedings; petitions, etc.:

Nissan North America, Inc., 59300-59301 04-22281 Motor vehicle safety standards; exemption petitions, etc.: Baby Trend, Inc., 59302 04-22280 NIH National Institutes of Health NOTICES Inventions, Government-owned; availability for licensing, 59261-59262 04-22151 NOAA National Oceanic and Atmospheric Administration RULES Fishery conservation and management: West Coast States and Western Pacific fisheries— Oregon sport fisheries; Pacific halibut; correction, 59303 C4-21553 National Science National Science Foundation NOTICES Meetings:

Environmental Research and Education Advisory Committee, 59277 04-22224 Equal Opportunities in Science and Engineering Advisory Committee, 59277 04-22222 Geosciences Advisory Committee, 59277 04-22225 Mathematical and Physical Sciences Advisory Committee, 59277-59278 04-22223 Nuclear Nuclear Regulatory Commission NOTICES Environmental statements; availability, etc.: University of Pittsburgh, 59278 04-22197 Meetings; Sunshine Act, 59278-59279 04-22308 Occupational Occupational Safety and Health Administration PROPOSED RULES Safety and health standards:

Hexavalent chromium; occupational exposure, 59305-59474 04-21488 Overseas Overseas Private Investment Corporation NOTICES Agency information collection activities; proposals, submissions, and approvals, 59279 04-22215 Privacy Act: Systems of records, 59279-59281 04-22230 Personnel Personnel Management Office PROPOSED RULES Acquisition regulations: Federal Employees Group Life Insurance— Administrative policy, practices, and clarifying language changes, 59166-59177 04-21922 Postal Postal Service RULES Domestic Mail Manual:

General information on Postal Service, 59139 04-22231 NOTICES Postage meters: Manually set postage meters: retirement plan, 59281-59282 04-22232 Presidential Presidential Documents PROCLAMATIONS *Special observances:* National Hunting and Fishing Day (Proc. 7822), republication with corrections, 59537-59540 04-22379 Reclamation Reclamation Bureau NOTICES Contract negotiations: Tabulation of water service and repayment; quarterly status report, 59265-59267 04-22263 Rural Rural Business-Cooperative Service NOTICES Loan guarentee authority; maximum portion available (2005 FY), 59185 04-22217 SEC Securities and Exchange Commission RULES Reports and guidance documents; availability, etc.:

Staff Accounting Bulletin, 59130-59131 04-22186 NOTICES Self-regulatory organizations; proposed rule changes: Fixed Income Clearing Corp., 59283-59285 E4-2465 National Association of Securities Dealers, Inc., E4-2468 59285-59286 04-22195 National Futures Association, 59286-59287 E4-2467 Pacific Exchange, Inc., 59287-59289 E4-2469 *Applications, hearings, determinations, etc.:* Allegheny Energy Inc., 59282-59283 E4-2463 SBA Small Business Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 59289 04-22200 Meetings:

District and Regional Advisory Councils— New York, 59289 04-22201 National Environmental Policy Act; implementation, 59289-59290 04-22187 Social Social Security Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 59290-59292 04-22219 State State Department NOTICES Presidential permits: Express Pipeline, LLC; pipeline facilities construction and maintenance in Montana and Wyoming, 59292-59299 04-22241 Substance Substance Abuse and Mental Health Services Administration NOTICES Meetings:

Substance Abuse Prevention Center National Advisory Council; correction, 59262 04-22339 Surface Surface Transportation Board NOTICES Railroad operation, acquisition, construction, etc.: Burlington Northern & Santa Fe Railway Co., 59302 04-22340 Textile Textile Agreements Implementation Committee See Committee for the Implementation of Textile Agreements Transportation Transportation Department See Federal Aviation Administration See Federal Highway Administration See National Highway Traffic Safety Administration See Surface Transportation Board Separate Parts In This Issue Part II Labor Department, Occupational Safety and Health Administration, 59305-59474 04-21488 Part III Housing and Urban Development Department, 59475-59488 04-22049 Part IV Transportation Department, Federal Aviation Administration, 59489-59498 04-22276 Part V Federal Communications Commission, 59499-59536 04-22189 Part VI The President, 59537-59540 04-22379 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. 69 191 Monday, October 4, 2004 Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 301 [Docket No. 04-025-2] Gypsy Moth Generally Infested Areas AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Affirmation of interim rule as final rule. SUMMARY: We are adopting as a final rule, without change, an interim rule that amended the gypsy moth regulations by adding one county in Ohio and seven counties in Wisconsin to the list of generally infested areas based on the detection of infestations of gypsy moth in those counties. As a result of the interim rule, the movement of regulated articles from those areas is restricted. The interim rule was necessary to prevent the artificial spread of gypsy moth to noninfested areas of the United States.

DATES: *Effective Date:* The interim rule became effective on June 7, 2004. FOR FURTHER INFORMATION CONTACT: Dr. Weyman Fussell, Program Manager, Pest Detection and Management Programs, PPQ, APHIS, 4700 River Road Unit 134, Riverdale, MD 20737-1231;

(301)734-5705. SUPPLEMENTARY INFORMATION: Background The gypsy moth, *Lymantria dispar* (Linnaeus), is a destructive pest of forest and shade trees. The gypsy moth regulations (contained in 7 CFR 301.45 through 301.45-12 and referred to below as the regulations) restrict the interstate movement of regulated articles from generally infested areas to prevent the artificial spread of the gypsy moth. In an interim rule effective and published in the **Federal Register** on June 7, 2004 (69 FR 31722-31723, Docket No. 04-025-1), we amended the regulations by adding one county in Ohio and seven counties in Wisconsin to the list of generally infested areas in § 301.45-3. Comments on the interim rule were required to be received on or before August 6, 2004. We did not receive any comments. Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule. This action also affirms the information contained in the interim rule concerning Executive Orders 12866, 12372, and 12988 and the Paperwork Reduction Act. Further, for this action, the Office of Management and Budget has waived its review under Executive Order 12866. Regulatory Flexibility Act This rule affirms an interim rule that amended the regulations by adding one county in Ohio and seven counties in Wisconsin to the list of generally infested areas. As a result of the interim rule, the interstate movement of certain articles from those areas is restricted. The interim rule was necessary to prevent the artificial spread of the gypsy moth to noninfested areas of the United States. The following analysis addresses the economic effects of the interim rule on small entities, as required by the Regulatory Flexibility Act. The interim rule placed restrictions on the movement of regulated articles and outdoor household articles

(OHAs)from and through the one county in Ohio and the seven counties in Wisconsin that were designated as generally infested areas. These restrictions will have their primary effect on persons moving OHAs, nursery stock, Christmas trees, logs and wood chips, and mobile homes from a generally infested area into or through any area that is not generally infested. Under the regulations, OHAs may not be moved from a generally infested area into or through a noninfested area unless they are accompanied by either a certificate issued by an inspector or an OHA document issued by the owner of the articles, attesting to the absence of all life stages of gypsy moth. Most individual homeowners moving their own articles who comply with the regulations choose to self-inspect and issue an OHA document. This takes a few minutes and involves no monetary cost unless treatment is necessary. Individuals may also have State-certified pesticide applicators, trained by the State or the U.S. Department of Agriculture (USDA), inspect and issue certificates. Generally, regulated articles (such as logs, pulpwood, wood chips, mobile homes, nursery stock, OHAs, and Christmas trees) may only be moved from a generally infested area if they are accompanied by a certificate or limited permit issued by an inspector. However, logs, wood chips, and pulpwood may be moved without a certificate or limited permit if the person moving the articles attaches a signed accurate statement to the waybill as specified in the Gypsy Moth Program Manual, stating that he or she has inspected the articles and has found them free of all life stages of the gypsy moth. This exception minimizes the costs of moving logs, pulpwood, and wood chips. Regulated articles may also be moved from a generally infested area without a certificate if they are moved by the USDA for experimental or scientific purposes and they are accompanied by a permit issued by the Administrator of the Animal and Plant Health Inspection Service (APHIS). Persons moving regulated articles from a generally infested area may obtain a certificate or limited permit from an inspector or a qualified certified applicator. Inspectors will issue these documents at no charge, but costs may result from delaying the movement of commercial articles while waiting for the inspection. Certificates for the movement of mobile homes from a generally infested area may also be obtained from qualified certified applicators. When inspection of regulated articles or OHAs reveals the presence of gypsy moths, treatment is often necessary in order for the articles to be eligible for movement into or through noninfested areas. The preferred treatment, scraping egg masses and spraying caterpillars, costs an average of $10 to $30 per shipment. Fumigation is another alternative, but it is more expensive, at $100 to $150 per shipment, and may damage the shipment. Treatment is done by qualified certified applicators, most of which are small businesses. These businesses might experience a small increase in income as a result of the interim rule. Nurseries and Christmas tree growers that move a substantial number of shipments from the generally infested areas would be able to minimize treatment costs by treating their premises for gypsy moths under a compliance agreement with APHIS. These treatments cost businesses between $10 and $20 per acre. This alternative allows nurseries and Christmas tree growers to issue their own certificates provided they are under a compliance agreement and is less costly than treating individual shipments. The entities most likely to choose this option are nurseries that move a substantial number of shipments from generally infested areas and that treat their premises for other pests in addition to the gypsy moth. Producers that do not operate under a compliance agreement with APHIS, but treat their premises under this option, would receive certification for each shipment from an inspector. The economic impact of the interim rule will vary depending on the size of the entities affected, the levels of infestation, and the size and number of shipments to noninfested areas. Within the one Ohio county and seven Wisconsin counties added to the list of generally infested areas, there are approximately 450 Christmas tree growers, nurseries, loggers, sawmills, and individuals involved in the movement of regulated articles that may incur costs from the interim rule. According to the size standards established by the Small Business Administration, all of these businesses are considered small entities. In Hocking County, the newly regulated county in Ohio, there are 25 potentially affected establishments. The value of Christmas tree and greenhouse/nursery products sold by these establishments in 2002 was $541,000, which represents 0.12 percent of the total value of sales of these products in Ohio. These businesses annually ship about 400 shipments, of which approximately half, or 200 shipments, leave the regulated area. Approximately 58 percent of the shipments leaving the regulated area would require treatment, creating an approximate cost range of $11,600 to $17,400 annually. Given these estimates, the cost of additional treatments would be small relative to the total value of sales in Hocking County. There are 425 potentially affected establishments in the seven Wisconsin counties. The value of Christmas tree and greenhouse/nursery products sold by these establishments in 2002 was $25.546 million, which represents approximately 11.57 percent of the total value of sales of these products in Wisconsin. These businesses annually ship about 2,150 shipments, of which approximately 34 percent, or 723 shipments, leave the regulated area. Only about 16 percent of the shipments from these areas would require treatment, with costs of approximately $11,568 to $17,352 annually. With these estimates, the cost of additional treatments would be very small relative to the total value of sales in the newly affected Wisconsin counties. The regulatory requirements imposed by the interim rule are expected to cause a slight increase in costs for the affected entities. The relative negative impact that may result from the interim rule is very small when compared with the potential for harm to related industry and the U.S. economy as a whole resulting from the further spread of the pest. Since the total value of the regulated articles moved from infested to noninfested areas is a small fraction of the national total, the effect on national prices is expected to be slight. Additionally, since the rule is not prohibitive, articles that meet the requirements of the regulations would continue to enter the market. Therefore, the overall impact upon price and competitiveness is expected to be relatively insignificant. Under these circumstances, the Administrator of the Animal and Plant Health Inspection Services has determined that this action will not have a significant impact on a substantial number of small entities. List of Subjects in 7 CFR Part 301 Agricultural commodities, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Transportation. PART 301—DOMESTIC QUARANTINE NOTICES Accordingly, we are adopting as a final rule, without change, the interim rule that amended 7 CFR part 301 and that was published at 69 FR 31722-31723 on June 7, 2004. Authority: 7 U.S.C. 7701-7772; 7 CFR 2.22, 2.80, and 371.3. Section 301.75-15 also issued under Sec. 204, Title II, Pub. L. 106-113, 113 Stat. 1501A-293; sections 301.75-15 and 301.75-16 also issued under Sec. 203, Title II, Pub. L. 106-224, 114 Stat. 400 (7 U.S.C. 1421 note). Done in Washington, DC, this 28th day of September 2004. Elizabeth E. Gaston, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 04-22221 Filed 10-1-04; 8:45 am]

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