Unknown. Interim rule; technical amendment
40,141 words·~182 min read·
/register/2007/01/12/07-80A 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-2007-01-12.xml --- 72 8 Friday, January 12, 2007 Contents Agriculture Agriculture Department See Animal and Plant Health Inspection Service See Forest Service PROPOSED RULES Farm Service Agency; State and county committees; selection and functions; amendments Correction, 1467 E7-298 Animal Animal and Plant Health Inspection Service RULES Plant-related quarantine, domestic: Citrus canker; technical correction, 1415 E7-370 Poultry improvement:
National Poultry Improvement Plan and auxiliary provisions; amendments, 1416-1426 E6-22635 Architectural Architectural and Transportation Barriers Compliance Board PROPOSED RULES Telecommunications Act accessibility guidelines and electronic and information technology accessibility standards: Telecommunications and Electronic and Information Technology Advisory Committee— Meetings, 1472-1473 E7-306 Army Army Department See Engineers Corps NOTICES Meetings: Army Science Board, 1495 07-93 Blind Blind or Severely Disabled, Committee for Purchase From People Who Are See Committee for Purchase From People Who Are Blind or Severely Disabled Centers Centers for Medicare & Medicaid Services NOTICES Agency information collection activities; proposals, submissions, and approvals, 1536-1537 E7-216 E7-225 Children Children and Families Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 1537-1538 07-86 07-87 Commerce Commerce Department See National Oceanic and Atmospheric Administration See Patent and Trademark Office Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement list; additions and deletions, 1490-1492 E7-328 E7-329 Procurement list; additions and deletions; correction, 1492 E7-326 E7-327 Community Community Development Financial Institutions Fund NOTICES Agency information collection activities; proposals, submissions, and approvals, 1578 E7-354 Consumer Consumer Product Safety Commission RULES Consumer Product Safety Act:
Portable generators; labeling requirements, 1443-1453 07-80 PROPOSED RULES Flammable Fabrics Act: Carpets and rugs; flammability standards, 1472 E7-266 Court Court Services and Offender Supervision Agency for the District of Columbia NOTICES Privacy Act; systems of records, 1494 E7-299 Defense Defense Department See Army Department See Engineers Corps NOTICES Meetings: Uniformed Services University of Health Sciences Board of Regents, 1494-1495 07-104 Drug Drug Enforcement Administration NOTICES *Applications, hearings, determinations, etc.:* Hospira, Inc.; correction, 1560 E7-309 Employment Employment and Training Administration PROPOSED RULES Aliens; temporary employment in U.S.:
E-3 visa category; labor-condition application requirements; filing procedures, 1650-1656 07-44 NOTICES Agency information collection activities; proposals, submissions, and approvals, 1560-1561 E7-352 Energy Energy Department See Federal Energy Regulatory Commission NOTICES Agency information collection activities; proposals, submissions, and approvals, 1495-1496 E7-307 Engineers Engineers Corps NOTICES Environmental statements; availability, etc.: Orange County, CA; San Juan Creek Watershed/Western San Mateo Creek Watershed;
Special Area Management Plan, 1495 E7-228 EPA Environmental Protection Agency PROPOSED RULES Air programs: Ambient air quality standards, national— Air quality designations and classifications; 8-hour ozone, 1473-1474 E7-355 Air quality implementation plans; approval and promulgation; various States: West Virginia, 1474-1485 E7-249 NOTICES Agency information collection activities; proposals, submissions, and approvals, 1509-1512 E7-341 E7-357 Environmental statements; availability, etc.:
Agency comment availability, 1512 E7-345 Agency weekly receipts, 1512-1513 E7-347 Pesticide registration, cancellation, etc.: Syngenta Seeds, Inc., 1513-1514 E7-253 Executive Executive Office of the President See Management and Budget Office See National Drug Control Policy Office Farm Farm Credit System Insurance Corporation NOTICES Civil money penalties; inflation adjustment, 1514-1515 E7-359 FAA Federal Aviation Administration RULES Air carrier certification and operations:
Portable oxygen concentrator devices onboard aircraft, 1442-1443 E7-339 Transport category airplanes— Thermal acoustic insulation; fire penetration resistance, 1438-1442 E7-338 Airworthiness directives: Boeing, 1427-1430 E7-220 Bombardier, 1430-1436 E7-223 Restricted areas, 1437-1438 E7-323 E7-392 VOR Federal airways, 1436 E7-322 PROPOSED RULES Airworthiness directives: Airbus, 1467-1472 E7-314 E7-315 NOTICES Aeronautical land-use assurance; waivers: Hallock Municipal Airport, MN, 1572-1573 07-34 Meetings:
RTCA, Inc., 1573 07-94 Federal Emergency Federal Emergency Management Agency RULES Flood elevation determinations: Texas and Maine, 1461-1463 E7-340 Federal Energy Federal Energy Regulatory Commission RULES Electric utilities (Federal Power Act): Federal land use fees; update, 1453-1455 E6-22365 NOTICES Electric rate and corporate regulation combined filings, 1504-1508 E7-269 E7-279 Hydroelectric applications, 1508-1509 E7-285 *Applications, hearings, determinations, etc.:* Central Kentucky Transmission Co., 1496 E7-274 City of Hamilton, Ohio, 1496 E7-284 Columbia Gas Transmission Corp., 1496-1497 E7-290 Columbia Gulf Transmission Co., 1497 E7-276 Crossroads Pipeline Co., 1497-1498 E7-275 Discovery Gas Transmission LLC, 1498 E7-288 E7-292 East Texas Electric Cooperative, Inc., et al., 1498-1499 E7-271 Florida Gas Transmission Co., LLC, 1499 E7-273 Gas Transmission Northwest Corp., 1499-1500 E7-280 E7-287 Great Bay Hydro Corp., 1500 E7-286 Gulfstream Natural Gas System, L.L.C., 1500-1501 E7-282 Maritimes & Northeast Pipeline L.L.C. et al., 1501 E7-283 Natural Gas Pipeline Co. of America, 1501-1502 E7-291 Northern Border Pipeline Co., 1502 E7-289 Northwest Pipeline Corp., 1502 E7-281 Pasadena, CA, 1502-1503 E7-278 Sea Robin Pipeline Co., LLC, 1503 E7-277 Stingray Pipeline Co., L.L.C., 1503-1504 E7-272 Texas Eastern Transmission, LP, 1504 E7-270 Federal Housing Federal Housing Finance Board NOTICES Federal home loan bank system:
Community financial institutions average total assets and directors annual compensation; limits; annual adjustments, 1515-1516 E7-369 Federal home loan bank system: Community support review; members selected for review; list, 1516-1531 07-106 Federal Motor Federal Motor Carrier Safety Administration NOTICES Meetings; Sunshine Act, 1573-1574 07-116 Federal Railroad Federal Railroad Administration NOTICES Exemption petitions, etc.: City of Placentia, CA, 1574 E7-319 New Jersey Transit Corp., 1574-1575 E7-318 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies:
Change in bank control, 1531 E7-332 Formations, acquisitions, and mergers, 1531 E7-333 FTC Federal Trade Commission NOTICES Agency information collection activities; proposals, submissions, and approvals, 1531-1533 E7-293 Premerger notification waiting periods; early terminations, 1533-1535 07-81 Fish Fish and Wildlife Service PROPOSED RULES Endangered and threatened species: Recovery plans— Slickspot peppergrass; withdrawn, 1622-1644 07-60 NOTICES Reports and guidance documents; availability, etc.:
Permit conditions for abatement activities using raptors, 1556-1557 E7-353 Food Food and Drug Administration RULES Food for human consumption: Food labeling— Nutrient content claim “lean”; expanded use, 1455-1459 E7-330 Medical devices: Reprocessed single-use devices; premarket notification exemptions termination; validation data submission requirement; withdrawn, 1460 07-105 PROPOSED RULES Human and animal drugs: Cattle material; prohited use in medical products for humans and drugs intended for use in ruminants, 1582-1619 E6-22329 NOTICES Agency information collection activities; proposals, submissions, and approvals, 1539-1540 E7-331 Forest Forest Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 1486-1487 E7-361 E7-366 Appealable decisions; legal notice:
Eastern Region, 1488-1490 07-83 Recreation fee areas: Siuslaw National Forest, OR; access fees, 1490 07-92 GSA General Services Administration NOTICES Meetings: Federal Acquisition Institute and Defense Acquisition University, 1535 E7-297 Health Health and Human Services Department See Centers for Medicare & Medicaid Services See Children and Families Administration See Food and Drug Administration See Health Resources and Services Administration See National Institutes of Health See Substance Abuse and Mental Health Services Administration NOTICES Meetings:
Vital and Health Statistics National Committee, 1535-1536 07-95 Health Health Resources and Services Administration NOTICES Reports and guidance documents; availability, etc.: 340B Drug Pricing Program; contract pharmacy services, 1540-1543 E7-334 Veterans Health Care Act, Section 602; definition of “patient”, 1543-1546 E7-335 Homeland Homeland Security Department See Federal Emergency Management Agency See Immigration and Customs Enforcement Bureau Housing Housing and Urban Development Department NOTICES Grants and cooperative agreements; availability, etc.:
Homeless assistance; excess and surplus Federal properties, 1556 07-37 Immigration Immigration and Customs Enforcement Bureau NOTICES Agency information collection activities; proposals, submissions, and approvals, 1555-1556 E7-343 E7-344 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See Surface Mining Reclamation and Enforcement Office Justice Justice Department See Drug Enforcement Administration Labor Labor Department See Employment and Training Administration NOTICES Reports and guidance documents; availability, etc.:
Occupational employee safety, health, workers’ compensation, voluntary employee health services, assistance, fitness, and Drug Free Workplace programs, 1646-1647 E7-264 Land Land Management Bureau NOTICES Realty actions; sales, leases, etc.: Nevada, 1557-1559 E7-429 Management Management and Budget Office NOTICES Federal programs; cost-effectiveness analysis; discount rates (Circular A-94), 1563-1564 E7-308 National Drug National Drug Control Policy Office NOTICES Agency information collection activities; proposals, submissions, and approvals, 1561 E7-342 National Highway National Highway Traffic Safety Administration NOTICES Motor vehicle safety standards; exemption petitions, etc.:
American Honda Motor Co., Inc., 1575 E7-316 NIH National Institutes of Health NOTICES Inventions, Government-owned; availability for licensing, 1547-1550 E7-349 E7-350 Meetings: National Heart, Lung, and Blood Institute, 1550-1551 07-97 07-100 07-101 National Institute of Environmental Health Sciences, 1550-1551 07-99 National Institute of Nursing Research, 1550 07-98 Scientific Review Center, 1551-1553 07-102 07-103 NOAA National Oceanic and Atmospheric Administration RULES Fishery conservation and management:
Alaska; fisheries of Exclusive Economic Zone— Aleutian Islands atka mackerel, 1463-1466 07-107 Nuclear Nuclear Regulatory Commission RULES Nuclear equipment and material; export and import: Exports to Libya restricted, 1426-1427 E7-320 NOTICES Agency information collection activities; proposals, submissions, and approvals, 1561-1562 E7-325 *Applications, hearings, determinations, etc.:* Carolina Power & Light Co., 1562-1563 E7-324 Office Office of Management and Budget See Management and Budget Office National Office of National Drug Control Policy See National Drug Control Policy Office Patent Patent and Trademark Office NOTICES Agency information collection activities; proposals, submissions, and approvals, 1492-1493 07-91 Pension Pension Benefit Guaranty Corporation RULES Single employer plans:
Allocation of assets— Interest assumptions for valuing and paying benefits, 1460-1461 E7-336 NOTICES Single employer plans: Interest rates and assumptions, 1564-1565 E7-337 SEC Securities and Exchange Commission NOTICES Agency information collection activities; proposals, submissions, and approvals, 1565-1567 E7-300 E7-301 E7-302 E7-303 E7-304 Meetings; Sunshine Act, 1567-1568 07-113 Options Price Reporting Authority: Consolidated Options Last Sale Reports and Quotation Information;
Reporting Plan; amendments, 1568 E7-313 Self-regulatory organizations; proposed rule changes: American Stock Exchange LLC; correction, 1579 Z6-22398 NASDAQ Stock Market LLC, 1569-1570 E7-311 E7-312 National Futures Association; correction, 1579 Z6-22657 NYSE Arca, Inc.; correction, 1579 Z6-22402 Options Clearing Corp., 1571-1572 E7-305 SBA Small Business Administration NOTICES Interest rates; quarterly determinations, 1572 E7-296 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 1553-1555 E7-310 Surface Surface Mining Reclamation and Enforcement Office NOTICES Agency information collection activities; proposals, submissions, and approvals, 1559-1560 07-88 Surface Surface Transportation Board NOTICES Railroad operation, acquisition, construction, etc.:
Union Pacific Railway Co., 1576 E7-163 Railroad services abandonment: BNSF Railway Co., 1576-1577 E7-229 Transportation Transportation Department See Federal Aviation Administration See Federal Motor Carrier Safety Administration See Federal Railroad Administration See National Highway Traffic Safety Administration See Surface Transportation Board NOTICES Aviation proceedings: Agreements filed; weekly receipts, 1572 E7-360 Treasury Treasury Department See Community Development Financial Institutions Fund NOTICES Agency information collection activities; proposals, submissions, and approvals, 1577-1578 E7-348 Separate Parts In This Issue Part II Health and Human Services Department, Food and Drug Administration, 1582-1619 E6-22329 Part III Interior Department, Fish and Wildlife Service, 1622-1644 07-60 Part IV Labor Department, 1646-1647 E7-264 Part V Labor Department, Employment and Training Administration, 1650-1656 07-44 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. 72 8 Friday, January 12, 2007 Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 301 [Docket No. APHIS-2006-0114] RIN 0579-AC07 Citrus Canker; Quarantine of the State of Florida;
Technical Amendment AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Interim rule; technical amendment. SUMMARY: In an interim rule published in the **Federal Register** on August 1, 2006, we amended the citrus canker regulations to list the entire State of Florida as a quarantined area for citrus canker and to amend the requirements for the movement of regulated articles from Florida now that the eradication of citrus canker in Florida is no longer being carried out as an objective.
We also amended the regulations to allow regulated articles that would not otherwise be eligible for interstate movement to be moved to a port for immediate export. In this amendment, we are clarifying that, if citrus canker is found in any grove during the preharvest inspection or afterward, fruit from that grove will be ineligible to move interstate for that entire shipping season. DATES: *Effective Date:* January 12, 2007. FOR FURTHER INFORMATION CONTACT: Mr. Stephen Poe, Senior Operations Officer, EDP, PPQ, APHIS, 4700 River Road Unit 137, Riverdale, MD 20737-1231;
(301)734-4387. SUPPLEMENTARY INFORMATION: Background The regulations in 7 CFR 301.75-1 through 301.75-14 (referred to below as the regulations) prohibit or restrict the interstate movement of regulated articles from and through areas quarantined because of citrus canker and provide conditions under which regulated fruit may be moved into, through, and from quarantined areas for packing. These regulations are promulgated pursuant to the Plant Protection Act (7 U.S.C. 7701 *et seq.* ). In an interim rule published in the **Federal Register** on August 1, 2006 (71 FR 43345-43352, Docket No. APHIS-2006-0114), we amended the regulations to list the entire State of Florida as a quarantined area for citrus canker and to amend the requirements for the movement of regulated articles from Florida now that the eradication of citrus canker in Florida is no longer being carried out as an objective. We also amended the regulations to allow regulated articles that would not otherwise be eligible for interstate movement to be moved to a port for immediate export. Following publication of the interim rule, it came to our attention that one of the provisions in the rule did not make clear our intention. As established by the interim rule, § 301.75-7 spells out the requirements that must be met in order for regulated fruit to be moved from a quarantined area. Paragraph (a)(2) of that section provides that, no more than 30 days before the beginning of harvest, every tree must be inspected by an inspector and the grove must be found free of citrus canker. Further, in groves producing limes, every tree must be inspected by an inspector and the grove must be found free of citrus canker every 120 days or less thereafter for as long as harvest continued. Some regulated entities have interpreted these provisions as allowing for the interstate movement of fruit from groves with trees showing signs of citrus canker, provided that the affected trees are removed and the grove is then reinspected prior to harvest and found free of citrus canker. This interpretation is not consistent with the intent of these provisions. Rather, these provisions are intended to only allow the interstate movement of fruit from groves where citrus canker has not been found during the preharvest inspection and afterward. Therefore, in order to avoid confusion, we are revising § 301.75-7(a)(2) to explicitly state that, if citrus canker is found in a grove when the preharvest inspection is conducted, or at any other time beginning August 1 of the year in which the fruit is to be harvested and extending through the harvest season (including into the next calendar year), fruit from the grove will not be eligible for interstate movement for the remainder of the harvest season. List of Subjects in 7 CFR Part 301 Agricultural commodities, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Transportation. Accordingly, we are amending 7 CFR part 301 as follows: PART 301—DOMESTIC QUARANTINE NOTICES 1. The authority citation for part 301 continues to read as follows: Authority: 7 U.S.C. 7701-7772 and 7781-7786; 7 CFR 2.22, 2.80, and 371.3. Section 301.75-15 issued under Sec. 204, Title II, Public Law 106-113, 113 Stat. 1501A-293; sections 301.75-15 and 301.75-16 issued under Sec. 203, Title II, Public Law 106-224, 114 Stat. 400 (7 U.S.C. 1421 note). 2. In § 301.75-7, paragraph (a)(2) is revised to read as follows: § 301.75-7 Interstate movement of regulated fruit from a quarantined area.
(a)* * *
(2)No more than 30 days before the beginning of harvest, every tree was inspected by an inspector and the grove was found free of citrus canker. Further, in groves producing limes, every tree was inspected by an inspector and the grove was found free of citrus canker every 120 days or less thereafter for as long as harvest continued. If citrus canker is found in a grove when the preharvest inspection is conducted, or at any other time beginning August 1 of the year in which the fruit is to be harvested and extending through the harvest season (including into the next calendar year), fruit from that grove will not be eligible for interstate movement for the remainder of the harvest season. Done in Washington, DC, this 8th day of January 2007. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E7-370 Filed 1-11-07; 8:45 am] BILLING CODE 3410-34-P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Parts 145 and 147 [Docket No. APHIS-2006-0008] RIN 0579-AC27 National Poultry Improvement Plan and Auxiliary Provisions AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Final rule. SUMMARY: We are amending the National Poultry Improvement Plan (the Plan) and its auxiliary provisions by providing new or modified sampling and testing procedures for Plan participants and participating flocks. The changes were voted on and approved by the voting delegates at the Plan's 2004 National Plan Conference. These changes will keep the provisions of the Plan current with changes in the poultry industry and provide for the use of new sampling and testing procedures. EFFECTIVE DATE: February 12, 2007. FOR FURTHER INFORMATION CONTACT: Mr. Andrew R. Rhorer, Senior Coordinator, Poultry Improvement Staff, National Poultry Improvement Plan, Veterinary Services, APHIS, USDA, 1498 Klondike Road, Suite 101, Conyers, GA 30094-5104;
(770)922-3496. SUPPLEMENTARY INFORMATION: Background The National Poultry Improvement Plan (NPIP, also referred to below as “the Plan”) is a cooperative Federal-State-industry mechanism for controlling certain poultry diseases. The Plan consists of a variety of programs intended to prevent and control egg-transmitted, hatchery-disseminated poultry diseases. Participation in all Plan programs is voluntary, but flocks, hatcheries, and dealers must first qualify as “U.S. Pullorum-Typhoid Clean” as a condition for participating in the other Plan programs. The Plan identifies States, flocks, hatcheries, and dealers that meet certain disease control standards specified in the Plan's various programs. As a result, customers can buy poultry that has tested clean of certain diseases or that has been produced under disease-prevention conditions. The regulations in 9 CFR parts 145 and 147 (referred to below as the regulations) contain the provisions of the Plan. The Animal and Plant Health Inspection Service (APHIS, also referred to as “the Service”) of the U.S. Department of Agriculture (USDA, also referred to as “the Department”) amends these provisions from time to time to incorporate new scientific information and technologies within the Plan. On June 19, 2006, we published in the **Federal Register** (71 FR 35203-35220, Docket No. APHIS-2006-0008) a proposal 1 to amend the Plan by providing new or modified sampling and testing procedures; adding a procedure for the approval of diagnostic test kits; reorganizing the egg-type and meat-type breeding chicken regulations to separate the regulations concerning primary breeding flocks from those concerning multiplier breeding flocks; and making other changes to update and clarify the regulations. 1 To view the proposed rule and the comment we received, go to *http://www.regulations.gov,* click on the “Advanced Search” tab, and select “Docket Search.” In the Docket ID field, enter APHIS-2006-0008, then click on “Submit.” Clicking on the Docket ID link in the search results page will produce a list of all documents in the docket. We solicited comments concerning our proposal for 60 days ending August 18, 2006. We received one comment by that date, from a private citizen. The commenter raised concerns about the welfare of poultry in an agricultural setting. APHIS does not have statutory authority to promulgate regulations regarding the welfare of poultry in an agricultural setting. The NPIP is designed to control the incidence of disease in breeding and commercial poultry. The commenter also stated that the Plan should have provisions for ensuring that Authorized Agents are not corrupt. The Official State Agencies that work with APHIS to administer the provisions of the Plan designate Authorized Agents to perform sampling on flocks that participate in the Plan. Each Official State Agency has provisions for determining whether persons are qualified to serve as Authorized Agents and for ensuring the integrity of Authorized Agents that it designates to perform tasks in the administration of the Plan. We are not making any changes in response to this commenter's comments. Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, without change. Executive Order 12866 and Regulatory Flexibility Act This rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget. We are amending the Plan and its auxiliary provisions by providing new or modified sampling and testing procedures for Plan participants and participating flocks. The proposed changes were voted on and approved by the voting delegates at the Plan's 2004 National Plan Conference. These changes will keep the provisions of the Plan current with changes in the poultry industry and provide for the use of new sampling and testing procedures. The poultry industry plays an important role in the U.S. economy, directly employing approximately 240,000 workers. 2 The poultry industry is primarily composed of two types of companies: Primary breeding companies and highly integrated companies that combine multiplier breeding, hatching, and growing functions. The primary breeder companies are responsible for the development of genetic lines of poultry for commercial companies that market the product to final consumers. They maintain and expand pure designated blood lines and supply breeding stock to commercial poultry companies all over the globe. Improved genetic poultry are multiplied through the hatchery system. The hatcheries, in turn, supply these more efficient birds to producers and growers in nearby States. Hatcheries incubate and hatch eggs and sell chicks to the commercial producer when they are 1 day old. The commercial producers grow the chicks either for meat production or as egg-laying varieties. The genetic lines of both egg-laying varieties and meat-producing poultry are carefully controlled by primary breeding companies. 2 USDA/FAS, Export Promotion Increase Employment in U.S. Poultry Industry, FASONLINE ( *http://www.fas.usda.gov/dlp/poultry/success.html* ), May 6, 2002. Almost all birds are produced on a contractual basis between a highly integrated company and individual contract growers who raise the birds, *i.e.* , growers. In such arrangements, the grower normally supplies the poultry house, land, labor, litter, equipment, taxes, utilities, and insurance, while the company provides the chicks, feed, necessary medications, and supervision. Labor and equipment for catching and hauling the birds to market are also provided by the company. The company retains title to the birds, and in return growers are paid according to the amount produced (pounds of birds or dozens of eggs). Currently, there are three major firms that produce primary breeding stock of egg-type chickens, three breeders of meat-type chickens, two breeders of turkey, and one firm producing both egg-type and meat-type chickens. All of these are large facilities headquartered in the United States, and all of them operate in domestic and international markets. Other multinational organizations headquartered in Europe, Israel, and Japan produce several varieties of breeding stock offered to commercial facilities around the globe. U.S. broiler production totaled 8.5 billion birds in 2003. Ten States accounted for over 79 percent of broilers produced in the United States (table 1). U.S. turkey production in 2003 totaled 274 million birds. The top 10 turkey-producing States accounted for 82 percent of total production. A total of 87.2 billion eggs were produced in 2003. Ten States accounted for 62 percent of total egg production. Approximately 85 percent of egg production was for human consumption (the table-egg market), while the remainder of production was for the hatching market. Table 1.—Broilers, Egg-Laying Chickens, and Turkeys: Value by Major States, 2003 Broilers State Value (million $) Egg-laying chickens State Value (million $) Turkeys State Value (million $) Georgia 2,143 Iowa 460 Minnesota 425 Arkansas 1,987 Georgia 396 North Carolina 398 Alabama 1,838 Ohio 374 Missouri 286 North Carolina 1,512 Pennsylvania 371 Virginia 177 Mississippi 1,424 Arkansas 344 Arkansas 176 Texas 1,032 Texas 310 South Carolina 172 Delaware 543 Indiana 308 California 151 Kentucky 507 Alabama 296 Indiana 139 Maryland 495 California 282 Pennsylvania 101 Virginia 442 North Carolina 242 Iowa 96 Other States 3,292 Other States 1,932 Other States 599 U.S. total 15,215 U.S. total 5,315 U.S. total 2,720 Source: USDA/NASS, Poultry-Production and Value: 2003 Summary, April 2004. Cash receipts from sales of poultry and eggs (broilers, farm chickens, eggs, turkey, ducks, and other poultry) were about $23.9 billion in 2003. 3 Of this total, 64 percent was from broilers, 22 percent from eggs, 11 percent from turkeys, and 3 percent from other poultry. In terms of tonnage, poultry production and trade exceeds that of beef or pork. For instance, in 2003, the United States produced 38.4 billion pounds of poultry meat, compared with 26.2 billion pounds of beef and 19.9 billion pounds of pork. Poultry meat per capita consumption (98.9 pounds) exceeded that of both beef (64.9 pounds) and pork (51.8). Furthermore, the United States exported more poultry meat (5,404 million pounds) than beef and veal (2,518 million pounds) or pork (1,717 million pounds) during the same period. 4 3 USDA/ERS, Cash receipts by commodity groups and selected commodities, United States, 1997-2003, August 2004. 4 USDA/ERS, Livestock, Dairy and Poultry Outlook/LDP-M-122, August 2004. The United States is a major exporter of poultry and poultry products. It exported poultry and poultry products valued at $2,287 million in 2003. 5 The major importers, accounting for $1,720 million worth of exports of U.S. poultry, are Russia ($384 million), Canada ($346 million), Mexico ($293 million), Hong Kong ($236 million), China ($117 million), Japan ($83 million), South Korea ($56 million), European Union ($126 million), Turkey ($42 million), and Taiwan ($37 million). U.S. imports of poultry and poultry products totaled $307 million. Of this total, $135 million was from Canada, $113 million from China, $19 million from Taiwan, and $16 million from France. 5 USDA/ERS, Foreign Agricultural Trade of the United States, September 2004. Impact on Small Entities The Regulatory Flexibility Act requires that agencies consider the economic impact of their rules on small entities. The Small Business Administration has established guidelines for determining which types of firms are to be considered small under the Regulatory Flexibility Act. The main entities that will be affected by this rule are those engaged in production of poultry breeding stock. Currently there are three major firms that produce primary breeding stock of egg-type chickens, three breeders of meat-type chickens, two breeders of turkeys, and one firm producing both egg-type and meat-type chickens. All of these are large facilities headquartered in the United States and operating in domestic and international markets. Additionally, broiler operations (North American Industry Classification System [NAICS] 112320), turkey operations (NAICS 112330), hatcheries (NAICS 112340) and other poultry operations (NAICS 112390) will be positively, at least qualitatively, affected, as they will benefit from the supply of improved and healthy breeding stock. There were a total of 79,600 commercial growers with sales in 2002. 6 Nearly 100 percent of broiler operations, 70 percent of turkey operations, and about 43 percent of layer operations produce poultry through production contracts. All of these commercial grower farms are considered to be small if they have annual sales of $750,000 or less. About 93 percent of these farms are small, while the rest are large. Commercial egg producers (NAICS 112310) are considered small if they have annual sales of less than $10.5 million. 6 USDA/NASS, 2002 Census of Agriculture-State Data (Table 13), page 356. This rule will introduce a series of minor changes to the NPIP and will not involve significant changes in program operations. Most of the changes involve clarifications, rearrangements of procedures, and definitions of terms. These changes are in line with the industry's best practices and will likely involve no additional costs in order to meet these requirements. Additionally, the NPIP is a voluntary program established between the industry and State and Federal governments. Any person producing or dealing in products may participate in the NPIP when he or she has demonstrated that his or her facilities, personnel, and practices are adequate for carrying out the applicable provisions of the NPIP. Since most countries will not accept hatching eggs or live birds from a producer unless it can be shown to be a NPIP participant, being a member of the NPIP allows greater ease in exporting hatching eggs or live birds to other countries. The poultry industry plays a very important role in the U.S. economy, and the final rule will help to ensure the safety of the industry and benefit the economy. Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities. Executive Order 12372 This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.) Executive Order 12988 This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule:
(1)Preempts all State and local laws and regulations that are in conflict with this rule;
(2)has no retroactive effect; and
(3)does not require administrative proceedings before parties may file suit in court challenging this rule. Paperwork Reduction Act This final rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). List of Subjects in 9 CFR Parts 145 and 147 Animal diseases, Poultry and poultry products, Reporting and recordkeeping requirements. Accordingly, we are amending 9 CFR parts 145 and 147 as follows: PART 145—NATIONAL POULTRY IMPROVEMENT PLAN 1. The authority citation for part 145 continues to read as follows: Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4. 2. Section 145.1 is amended as follows: a. By revising the definition of *Authorized Agent* to read as set forth below. b. By adding, in alphabetical order, a new definition of *Authorized Testing Agent* to read as set forth below. § 145.1 Definitions. *Authorized Agent.* Any person designated under § 145.11(a) to collect official samples for submission to an authorized laboratory as described in §§ 147.1(a) and 147.12 of this subchapter. *Authorized Testing Agent.* Any person designated under § 145.11(a) to collect official samples for submission to an authorized laboratory as described in §§ 147.1(a) and 147.12 of this subchapter and to perform the stained antigen, rapid whole blood test for pullorum typhoid. 3. In § 145.11, paragraphs
(a)and
(b)are revised to read as follows: § 145.11 Supervision.
(a)The Official State Agency may designate qualified persons as Authorized Agents to do the sample collecting provided for in § 145.14 and may designate qualified persons as Authorized Testing Agents to do the sample collecting and blood testing provided for in § 145.14.
(b)The Official State Agency shall employ or authorize qualified persons as State Inspectors to perform the qualification testing of participating flocks, and to perform the official inspections necessary to verify compliance with the requirements of the Plan. § 145.12 [Amended] 4. In § 145.12, paragraph (a), the word “inspected” is removed and the words “audited at least one time annually or” are added in its place. 5. In § 145.14, in the introductory text of the section, the second, third, and fifth sentences are revised to read as follows: § 145.14 Blood testing. * * * Blood samples for official tests shall be drawn by an Authorized Agent, Authorized Testing Agent, or State Inspector and tested by an authorized laboratory, except that the stained antigen, rapid whole-blood test for pullorum-typhoid may be conducted by an Authorized Testing Agent or State Inspector. For Plan programs in which a representative sample may be tested in lieu of an entire flock, except the ostrich, emu, rhea, and cassowary program in § 145.63(a), the minimum number tested shall be 30 birds per house, with at least 1 bird taken from each pen and unit in the house. * * * In houses containing fewer than 30 birds other than ostriches, emus, rheas, and cassowaries, all birds in the house must be tested. 6. A new § 145.15 is added to Subpart A to read as follows: § 145.15 Approved tests.
(a)The procedures for the bacteriological examination of poultry and poultry environments described in part 147 of this subchapter are approved tests for use in the NPIP. In addition, all tests that use veterinary biologics ( *e.g.,* antiserum and other products of biological origin) that are licensed or produced by the Service and used as described in part 147 of this subchapter are approved for use in the NPIP.
(b)Diagnostic test kits that are not licensed by the Service ( *e.g.,* bacteriological culturing kits) may be approved through the following procedure:
(1)The sensitivity of the kit will be estimated in at least three authorized laboratories selected by the Service by testing known positive samples, as determined by the official NPIP procedures found in part 147 of this subchapter. If certain conditions or interfering substances are known to affect the performance of the kit, appropriate samples will be included so that the magnitude and significance of the effect(s) can be evaluated.
(2)The specificity of the kit will be estimated in at least three authorized laboratories selected by the Service by testing known negative samples, as determined by the official NPIP procedures found in part 147 of this subchapter. If certain conditions or interfering substances are known to affect the performance of the kit, appropriate samples will be included so that the magnitude and significance of the effect(s) can be evaluated.
(3)The kit will be provided to the cooperating laboratories in its final form and include the instructions for use. The cooperating laboratories must perform the assay exactly as stated in the supplied instructions. Each laboratory must test a panel of at least 25 known positive clinical samples supplied by the manufacturer of the test kit. In addition, each laboratory will be asked to test 50 known negative clinical samples obtained from several sources, to provide a representative sampling of the general population. The identity of the samples must be coded so that the cooperating laboratories are blinded to identity and classification. Each sample must be provided in duplicate or triplicate, so that error and repeatability data may be generated.
(4)Cooperating laboratories will submit to the kit manufacturer all raw data regarding the assay response. Each sample tested will be reported as positive or negative and the official NPIP procedure used to classify the sample must be submitted in addition to the assay response value.
(5)The findings of the cooperating laboratories will be evaluated by the NPIP technical committee, and the technical committee will make a recommendation regarding whether to approve the test kit to the General Conference Committee. If the technical committee recommends approval, the final approval will be granted in accordance with the procedures described in §§ 147.46 and 147.47 of this subchapter. 7. In subpart B, the subpart heading is revised to read as follows: Subpart B—Special Provisions for Multiplier Egg-Type Chicken Breeding Flocks and Products § 145.22 [Amended] 8. Section 145.22 is amended as follows: a. In the introductory text, by adding the word “multiplier” before the words “egg type”. b. In paragraph (b), by removing the word “primary” and adding the word “multiplier” in its place. § 145.23 [Amended] 9. Section 145.23 is amended as follows: a. In paragraph (b)(2), in the introductory text, by removing the words “or a breeding flock composed of progeny of a primary breeding flock which is intended solely for the production of multiplier breeding flocks,”. b. In paragraph (b)(2)(iii), by adding the word “Testing” after the word “Authorized”. c. By removing paragraph (b)(5). d. By removing and reserving paragraph (c)(1)(i). e. In paragraph (c)(2), by removing the words “: *Provided,* That U.S. M. Gallisepticum Clean chicks from primary breeding flocks shall be produced in incubators and hatchers in which only eggs from flocks qualified under paragraph (c)(1)(i) of this section are set”. f. By removing and reserving paragraph (e)(1)(i). g. In paragraph (e)(2), by removing the words “: *Provided,* That U.S. M. Synoviae Clean chicks from primary breeding flocks shall be produced in incubators and hatchers in which only eggs from flocks qualified under paragraph (e)(1)(i) or
(ii)of this section are set”. h. By removing and reserving paragraph (h)(1). i. In paragraph (h)(2)(i), by adding the words “: *Provided:* That multiplier spent fowl must be tested within 30 days prior to movement to disposal” after the words “180 days”. § 145.24 [Amended] 10. Section 145.24 is amended as follows: a. In paragraph (a)(1)(i), by removing the word “and” and by adding the words “, § 145.73(b)(2)(i), and § 145.83(b)(2)(i)” immediately before the period. b. By adding and reserving paragraph (b). 11. In subpart C, the subpart heading is revised to read as follows: Subpart C—Special Provisions for Multiplier Meat-Type Chicken Breeding Flocks and Products § 145.32 [Amended] 12. Section 145.32 is amended as follows: a. In the introductory text, by adding the word “multiplier” before the words “meat type”. b. In paragraph (b), by removing the word “primary” and adding the word “multiplier” in its place. § 145.33 [Amended] 13. Section 145.33 is amended as follows: a. In paragraph (b)(2), in the introductory text, by removing the words “or a breeding flock composed of progeny of a primary breeding flock which is intended solely for the production of multiplier breeding flocks,”. b. In paragraph (b)(2)(iii), by adding the word “Testing” after the word “Authorized”. c. By removing paragraph (b)(5). d. By removing and reserving paragraph (c)(1)(i). e. In paragraph (c)(2), by removing the words “: *Provided,* That U.S. M. Gallisepticum Clean chicks from primary breeding flocks shall be produced in incubators and hatchers in which only eggs from flocks qualified under paragraph (c)(1)(i) of this section are set”. f. By removing and reserving paragraph (e)(1)(i). g. In paragraph (e)(2), by removing the words “: *Provided,* That U.S. M. Synoviae Clean chicks from primary breeding flocks shall be produced in incubators and hatchers in which only eggs from flocks qualified under paragraph (e)(1)(i) or
(ii)of this section are set”. h. By removing and reserving paragraphs
(h)and (i). i. By removing and reserving paragraph (l)(1). j. In paragraph (l)(2), in the introductory text, by adding the words “and prior to the onset of egg production” after the word “age.” k. In paragraph (l)(2)(i), by adding the words “: *Provided:* That multiplier spent fowl must be tested within 30 days prior to movement to slaughter” after the words “180 days.” § 145.34 [Amended] 14. Section 145.34 is amended as follows: a. In paragraph (a)(1)(i), by removing the word “and” and by adding the words “, § 145.73(b)(2)(i), and § 145.83(b)(2)(i)” immediately before the period. b. In paragraph (b)(1)(ii), by adding the words “in accordance with §§ 145.33(c) and 145.83(c)” after the word “Clean”. 15. Section 145.43 is amended as follows: a. In paragraph (b)(2)(iii), by adding the word “Testing” after the word “Authorized”. b. By revising paragraphs (f)(1), (f)(2), (f)(7), (g)(1) introductory text, (g)(1)(i), (g)(2) introductory text, and (g)(2)(i) to read as set forth below. § 145.43 Terminology and classification; flocks and products.
(f)* * *
(1)Hatchery debris (dead germ hatching eggs, fluff, and meconium collected by sexors), swabs collected from hatch debris in hatcher trays, a sample of all the poults that died within 10 days after hatching up to 10 poults, or a combination of 2 or all 3 of the above, from each hatch or a candidate breeding flock produced by a primary breeder, are examined bacteriologically at an authorized laboratory for *Salmonella.*
(2)The poults for the candidate breeding flock are placed in a building that has been cleaned and disinfected. An Authorized Agent must collect environmental samples from the building and submit them to an authorized laboratory for a bacteriological examination for the presence of *Salmonella,* as described in § 147.12 of this subchapter.
(7)Hatchery debris (dead germ hatching eggs, fluff, and meconium collected by sexors), swabs collected from hatch debris in hatcher trays, a sample of all the poults that died within 10 days after hatching up to 10 poults, or a combination of 2 or all 3 of the above, shall be cultured as a means of evaluating the effectiveness of the control procedures.
(g)* * *
(1)It is a primary breeding flock in which a minimum of 30 birds has been tested negative for antibodies to type A avian influenza virus by the agar gel immunodiffusion test specified in § 147.9 of this subchapter. Positive samples shall be further tested by an authorized laboratory using the hemagglutination inhibition test to detect antibodies to the hemagglutinin subtypes H5 and H7 when more than 4 months of age and prior to the onset of egg production. To retain this classification:
(i)A sample of at least 30 birds must be tested negative at intervals of 90 days; *Provided,* that primary spent fowl be tested within 30 days prior to movement to disposal; or
(2)It is a multiplier breeding flock in which a minimum of 30 birds has been tested negative for antibodies to type A avian influenza virus by the agar gel immunodiffusion test specified in § 147.9 of this subchapter. Positive samples shall be further tested by an authorized laboratory using the hemagglutination inhibition test to detect antibodies to the hemagglutinin subtypes H5 and H7 when more than 4 months of age and prior to the onset of egg production. To retain this classification:
(i)A sample of at least 30 birds must be tested negative at intervals of 180 days; *Provided,* that multiplier spent fowl be tested within 30 days prior to movement to disposal; or § 145.53 [Amended] 16. Section 145.53 is amended as follows: a. In paragraph (b)(2)(iii), by adding the word “Testing” after the word “Authorized”. b. In paragraph (e), in the paragraph heading, by adding the words “ *H5/H7* ” before the words “ *Avian Influenza* ”. c. In the introductory text of paragraphs (e), (e)(1), and (e)(2), by adding the words “the H5 and H7 subtypes of” before the words “avian influenza” each time they occur. 17. In § 145.63, paragraph (a)(2) is revised to read as follows: § 145.63 Terminology and classification; flocks and products.
(a)* * *
(2)It is a breeding flock that meets one of the following criteria: (i)(A) It is a multiplier or primary breeding flock of fewer than 300 birds in which a sample of 10 percent of the birds in a flock or at least 1 bird from each pen, whichever is more, has been officially tested for pullorum-typhoid within the past 12 months with no reactors; or
(B)It is a multiplier or primary breeding flock of 300 birds or more in which a sample of a minimum of 30 birds has been officially tested for pullorum-typhoid within the past 12 months with no reactors.
(ii)It is a flock that has already been designated U.S. Pullorum-Typhoid Clean and uses a subsequent bacteriological examination monitoring program of hatcher debris or eggs for ostriches, emus, rheas, or cassowaries acceptable to the Official State Agency and approved by the Service in lieu of annual blood testing.
(iii)It is a multiplier breeding flock located in a State that has been deemed to be a U.S. Pullorum-Typhoid Clean State for the past 3 years, and during which time no isolation of pullorum or typhoid has been made that can be traced to a source in that State, that uses a bacteriological examination monitoring program of hatcher debris or eggs or a serological examination monitoring program acceptable to the Official State Agency and approved by the Service in lieu of annual blood testing. 18. A new Subpart G is added to read as follows: Subpart G—Special Provisions for Primary Egg-Type Chicken Breeding Flocks and Products Sec. 145.71 Definitions. 145.72 Participation. 145.73 Terminology and classification; flocks and products. Subpart G—Special Provisions for Primary Egg-Type Chicken Breeding Flocks and Products § 145.71 Definitions. Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean: *Chicks.* Newly hatched chickens. *Primary egg-type chicken breeding flocks.* Foundation flocks that are composed of pedigree, great-grandparent, and grandparent stock that has been developed for egg production and are maintained for the principal purpose of producing multiplier breeding chicks used to produce table egg layers. *Started chickens.* Young chickens (chicks, pullets, cockerels, capons) which have been fed and watered and are less than 6 months of age. § 145.72 Participation. Participating flocks of primary egg-type chickens, and the eggs and chicks produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart G.
(a)Started chickens shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a).
(b)Hatching eggs produced by primary breeding flocks shall be fumigated (see § 147.25 of this subchapter) or otherwise sanitized.
(c)Any nutritive material provided to chicks must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10. § 145.73 Terminology and classification; flocks and products. Participating flocks, and the eggs and chicks produced from them, which have met the respective requirements specified in this section, may be designated by the following terms and the corresponding designs illustrated in § 145.10:
(a)[Reserved]
(b)*U.S. Pullorum-Typhoid Clean.* A flock in which freedom from pullorum and typhoid has been demonstrated to the Official State Agency under the criteria in paragraph (b)(1) or (b)(2) of this section: *Provided,* That a flock qualifying by means of a blood test shall be tested within the past 12 months, except that the retesting of a participating flock which is retained for more than 12 months shall be conducted a minimum of 4 weeks after the induction of molt. (See § 145.14 relating to the official blood test where applicable.)
(1)It has been officially blood tested with no reactors.
(2)It is a primary breeding flock that meets the following criteria:
(i)The primary breeding flock is located in a State in which pullorum disease or fowl typhoid is not known to exist nor to have existed in hatchery supply flocks during the preceding 12 months and in which it has been determined by the Service that:
(A)All hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision;
(B)All hatchery supply flocks within the State are qualified as U.S. Pullorum-Typhoid Clean or have met equivalent requirements for pullorum-typhoid control under official supervision: *Provided,* That if other domesticated fowl, except waterfowl, are maintained on the same premises as the participating flock, freedom from pullorum-typhoid infection shall be demonstrated by an official blood test of each of these fowl;
(C)All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited;
(D)All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which *S. pullorum* or *S. gallinarum* is isolated;
(E)All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; *Provided,* That if the origin of the infection involves another State, or if there is exposure to poultry in another State from the infected flock, then officials administering the National Poultry Improvement Plan will conduct an investigation;
(F)All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested following the procedure for reacting flocks as contained in § 145.14(a)(5), and all birds fail to demonstrate pullorum or typhoid infection;
(G)All poultry, including exhibition, exotic, and game birds, but excluding waterfowl, going to public exhibition shall come from U.S. Pullorum-Typhoid Clean or equivalent flocks, or have had a negative pullorum-typhoid test within 90 days of going to public exhibition; and
(H)Discontinuation of any of the conditions or procedures described in paragraphs (b)(2)(i)(A) through (b)(2)(i)(G) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in poultry breeding flocks within or originating within the State shall be grounds for the Service to revoke its determination that such conditions and procedures have been met or complied with. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity to present its views; and
(ii)In the primary breeding flock, a sample of 300 birds from flocks of more than 300, and each bird in flocks of 300 or less, has been officially tested for pullorum-typhoid with no reactors: *Provided,* That a bacteriological examination monitoring program acceptable to the Official State Agency and approved by the Service may be used in lieu of blood testing.
(c)*U.S. M. Gallisepticum Clean.*
(1)A flock maintained in compliance with the provisions of § 147.26 of this subchapter and in which freedom from *M. gallisepticum* has been demonstrated under the criteria specified in paragraph (c)(1)(i) of this section.
(i)It is a flock in which all birds or a sample of at least 300 birds has been tested for *M. gallisepticum* as provided in § 145.14(b) when more than 4 months of age: *Provided,* That to retain this classification, a minimum of 150 birds shall be tested at intervals of not more than 90 days: *And provided further,* That a sample comprised of fewer than 150 birds may be tested at any one time, if all pens are equally represented and a total of 150 birds is tested within each 90-day period.
(ii)[Reserved]
(2)A participant handling U.S. M. Gallisepticum Clean products shall handle only products of equivalent status.
(3)U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in § 147.24(a) of this subchapter.
(d)*U.S. S. Enteritidis Clean.* This classification is intended for primary egg-type breeders wishing to assure their customers that the hatching eggs and multiplier chicks produced are certified free of *Salmonella enteritidis* .
(1)A flock and the hatching eggs and chicks produced from it which have met the following requirements as determined by the Official State Agency:
(i)The flock originated from a U.S. S. Enteritidis Clean flock, or meconium from the chick boxes and a sample of chicks that died within 7 days after hatching are examined bacteriologically for salmonella at an authorized laboratory. Cultures from positive samples shall be serotyped.
(ii)All feed fed to the flock shall meet the following requirements:
(A)Pelletized feed shall contain either no animal protein or only animal protein products produced under the Animal Protein Products Industry
(APPI)*Salmonella* Education/Reduction Program. The protein products must have a minimum moisture content of 14.5 percent and must have been heated throughout to a minimum temperature of 190 °F, or above, or to a minimum temperature of 165 °F for at least 20 minutes, or to a minimum temperature of 184 °F under 70 lbs. pressure during the manufacturing process.
(B)Mash feed may contain no animal protein other than an APPI animal protein product supplement manufactured in pellet form and crumbled: *Provided,* That mash feed may contain nonpelleted APPI animal protein product supplements if the finished feed is treated with a salmonella control product approved by the U.S. Food and Drug Administration.
(iii)Feed shall be stored and transported in such a manner as to prevent possible contamination;
(iv)The flock is maintained in compliance with §§ 147.21, 147.24(a), and 147.26 of this subchapter. Rodents and other pests should be effectively controlled;
(v)Environmental samples shall be collected from the flock by an Authorized Agent, as described in § 147.12 of this subchapter, when the flock is 2 to 4 weeks of age. The samples shall be examined bacteriologically for group D salmonella at an authorized laboratory. Cultures from positive samples shall be serotyped. The Authorized Agent shall also collect samples every 30 days after the first sample has been collected.
(vi)If a *Salmonella* vaccine is used that causes positive reactions with pullorum-typhoid antigen, one of the following options must be utilized.
(A)Administer the vaccine after the pullorum-typhoid testing is done as described in paragraph (d)(1)(vii) of this section.
(B)If an injectable bacterin or live vaccine that does not spread is used, keep a sample of 350 birds unvaccinated and banded for identification until the flock reaches at least 4 months of age. Following negative serological and bacteriological examinations as described in paragraph (d)(1)(vii) of this section, vaccinate the banded, non-vaccinated birds.
(vii)Blood samples from 300 non-vaccinated birds as described in paragraph (d)(1)(vi) of this section shall be tested with either pullorum antigen or by a federally licensed *Salmonella enteritidis* enzyme-linked immunosorbent assay (ELISA) test when the flock is more than 4 months of age. All birds with positive or inconclusive reactions, up to a maximum of 25 birds, shall be submitted to an authorized laboratory and examined for the presence of group D salmonella, as described in § 147.11 of this subchapter. Cultures from positive samples shall be serotyped.
(viii)Hatching eggs are collected as quickly as possible and are handled as described in § 147.22 of this subchapter and are sanitized or fumigated (see § 147.25 of this subchapter).
(ix)Hatching eggs produced by the flock are incubated in a hatchery that is in compliance with the recommendations in §§ 147.23 and 147.24(b) of this subchapter, and sanitized either by a procedure approved by the Official State Agency or fumigated (see § 147.25 of this subchapter).
(2)A flock shall not be eligible for this classification if *Salmonella enteritidis* serotype *enteritidis*
(SE)is isolated from a specimen taken from a bird in the flock. Isolation of SE from an environmental or other specimen, as described in paragraph (d)(1)(v) of this section, will require bacteriological examination for SE in an authorized laboratory, as described in § 147.11(a) of this subchapter, of a random sample of 60 live birds from a flock of 5,000 birds or more, or 30 live birds from a flock with fewer than 5,000 birds. If only one specimen is found positive for SE, the participant may request bacteriological examination of a second sample, equal in size to the first sample, from the flock. If no SE is recovered from any of the specimens in the second sample, the flock will be eligible for the classification.
(3)A non-vaccinated flock shall be eligible for this classification if SE is isolated from an environmental sample collected from the flock in accordance with paragraph (d)(1)(v) of this section: *Provided,* That testing is conducted in accordance with paragraph (d)(1)(vii) of this section each 30 days and no positive samples are found.
(4)In order for a hatchery to sell products of this classification, all products handled shall meet the requirements of the classification.
(5)This classification may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures. The Official State Agency shall not revoke the participant's classification until the participant has been given an opportunity for a hearing in accordance with rules of practice adopted by the Official State Agency.
(e)*U.S. M. Synoviae Clean.*
(1)A flock maintained in compliance with the provisions of § 147.26 of this subchapter and in which freedom from *M. synoviae* has been demonstrated under the criteria specified in paragraph (e)(1)(i) of this section.
(i)It is a flock in which a minimum of 300 birds has been tested for *M. synoviae* as provided in § 145.14(b) when more than 4 months of age: *Provided,* That to retain this classification, a sample of at least 150 birds shall be tested at intervals of not more than 90 days: *And provided further,* That a sample comprised of fewer than 150 birds may be tested at any one time if all pens are equally represented and a total of 150 birds is tested within each 90-day period.
(ii)[Reserved]
(2)A participant handling U.S. M. Synoviae Clean products shall handle only products of equivalent status.
(3)U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in § 147.24(a) of this subchapter.
(f)*U.S. Avian Influenza Clean.* This program is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of avian influenza. It is intended to determine the presence of avian influenza in primary breeding chickens through routine serological surveillance of each participating breeding flock. A flock and the hatching eggs and chicks produced from it will qualify for this classification when the Official State Agency determines that they have met the following requirements:
(1)It is a primary breeding flock in which a minimum of 30 birds have been tested negative for antibodies to avian influenza when more than 4 months of age. To retain this classification:
(i)A sample of at least 30 birds must be tested negative at intervals of 90 days: *Provided,* That primary spent fowl must be tested within 30 days prior to movement to disposal; or
(ii)A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds is tested within each 90-day period.
(2)[Reserved] 19. A new subpart H is added to read as follows: Subpart H—Special Provisions for Primary Meat-Type Chicken Breeding Flocks and Products Sec. 145.81 Definitions. 145.82 Participation. 145.83 Terminology and classification; flocks and products. Subpart H—Special Provisions for Primary Meat-Type Chicken Breeding Flocks and Products § 145.81 Definitions. Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean: *Chicks.* Newly hatched chickens. *Primary meat-type chicken breeding flocks.* Foundation flocks that are composed of pedigree, great-grandparent, and grandparent stock that has been developed for meat production and are maintained for the principal purpose of producing multiplier breeding chicks used to produce commercial broilers. *Started chickens.* Young chickens (chicks, pullets, cockerels, capons) which have been fed and watered and are less than 6 months of age. § 145.82 Participation. Participating flocks of primary meat-type chickens, and the eggs and chicks produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart H.
(a)Started chickens shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a).
(b)Hatching eggs produced by primary breeding flocks shall be fumigated (see § 147.25 of this subchapter) or otherwise sanitized.
(c)Any nutritive material provided to chicks must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10. § 145.83 Terminology and classification; flocks and products. Participating flocks, and the eggs and chicks produced from them, which have met the respective requirements specified in this section, may be designated by the following terms and the corresponding designs illustrated in § 145.10:
(a)[Reserved]
(b)*U.S. Pullorum-Typhoid Clean.* A flock in which freedom from pullorum and typhoid has been demonstrated to the Official State Agency under the criteria in paragraph (b)(1) or (b)(2) of this section: *Provided,* That a flock qualifying by means of a blood test shall be tested within the past 12 months, except that the retesting of a participating flock which is retained for more than 12 months shall be conducted a minimum of 4 weeks after the induction of molt. (See § 145.14 relating to the official blood test where applicable.)
(1)It has been officially blood tested with no reactors.
(2)It is a primary breeding flock that meets the following criteria:
(i)The primary breeding flock is located in a State in which pullorum disease or fowl typhoid is not known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months and in which it has been determined by the Service that:
(A)All hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision;
(B)All hatchery supply flocks within the State are qualified as U.S. Pullorum-Typhoid Clean or have met equivalent requirements for pullorum-typhoid control under official supervision: *Provided,* That if other domesticated fowl, except waterfowl, are maintained on the same premises as the participating flock, freedom from pullorum-typhoid infection shall be demonstrated by an official blood test of each of these fowl;
(C)All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited;
(D)All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which *S. pullorum* or *S. gallinarum* is isolated;
(E)All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; *Provided,* That if the origin of the infection involves another State, or if there is exposure to poultry in another State from the infected flock, then officials administering the National Poultry Improvement Plan will conduct an investigation;
(F)All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested following the procedure for reacting flocks as contained in § 145.14(a)(5) of this subchapter, and all birds fail to demonstrate pullorum or typhoid infection;
(G)All poultry, including exhibition, exotic, and game birds, but excluding waterfowl, going to public exhibition shall come from U.S. Pullorum-Typhoid Clean or equivalent flocks, or have had a negative pullorum-typhoid test within 90 days of going to public exhibition; and
(H)Discontinuation of any of the conditions or procedures described in paragraphs (b)(2)(i)(A) through (b)(2)(i)(G) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in poultry breeding flocks within or originating within the State shall be grounds for the Service to revoke its determination that such conditions and procedures have been met or complied with. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity to present its views; and
(ii)In the primary breeding flock, a sample of 300 birds from flocks of more than 300, and each bird in flocks of 300 or less, has been officially tested for pullorum-typhoid with no reactors: *Provided,* That a bacteriological examination monitoring program acceptable to the Official State Agency and approved by the Service may be used in lieu of blood testing.
(c)*U.S. M. Gallisepticum Clean.*
(1)A flock maintained in compliance with the provisions of § 147.26 of this subchapter and in which freedom from *M. gallisepticum* has been demonstrated under the criteria specified in paragraph (c)(1)(i) of this section.
(i)It is a flock in which all birds or a sample of at least 300 birds has been tested for *M. gallisepticum* as provided in § 145.14(b) of this subchapter when more than 4 months of age: *Provided,* That to retain this classification, a minimum of 40 birds shall be tested at intervals of not more than 28 days, and a total of at least 150 birds shall be tested within each 90-day period.
(ii)[Reserved]
(2)A participant handling U.S. M. Gallisepticum Clean products must handle only products of equivalent status.
(3)U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in § 147.24(a) of this subchapter.
(d)*U.S. M. Synoviae Clean.*
(1)A flock maintained in compliance with the provisions of § 147.26 of this subchapter and in which freedom from *M. synoviae* has been demonstrated under the criteria specified in paragraph (d)(1)(i) of this section.
(i)It is a flock in which all birds or a sample of at least 300 birds has been tested for *M. synoviae* as provided in § 145.14(b) of this subchapter when more than 4 months of age: *Provided,* That to retain this classification, a sample of at least 40 birds shall be tested at intervals of not more than 28 days, and a total of at least 150 birds shall be tested within each 90-day period.
(ii)[Reserved]
(2)A participant handling U.S. M. Synoviae Clean products shall handle only products of equivalent status.
(3)U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in § 147.24(a) of this subchapter.
(e)*U.S. S. Enteritidis Clean.* This classification is intended for primary meat-type breeders wishing to assure their customers that the chicks produced are certified free of *Salmonella enteritidis.*
(1)A flock and the hatching eggs and chicks produced from it shall be eligible for this classification if they meet the following requirements, as determined by the Official State Agency:
(i)The flock originated from a U.S. S. Enteritidis Clean flock, or one of the following samples has been examined bacteriologically for *S. enteritidis* at an authorized laboratory and any group *D Salmonella* samples have been serotyped:
(A)A 25-gram sample of meconium from the chicks in the flock collected and cultured as described in § 147.12(a)(5) of this subchapter; or
(B)A sample of chick papers collected and cultured as described in § 147.12(c) of this subchapter; or
(C)A sample of 10 chicks that died within 7 days after hatching.
(ii)All feed fed to the flock meets the following requirements:
(A)Pelletized feed must have a minimum moisture content of 14.5 percent and must have been heated throughout to a minimum temperature of 190 °F, or to a minimum temperature of 165 °F for at least 20 minutes, or to a minimum temperature of 184 °F under 70 lbs. pressure during the manufacturing process;
(B)Mash feed may contain animal protein if the finished feed is treated with a salmonella control product approved by the U.S. Food and Drug Administration.
(C)All feed is stored and transported in such a manner as to prevent possible contamination.
(iii)The flock is maintained in compliance with §§ 147.21, 147.24(a), and 147.26 of this subchapter.
(iv)Environmental samples are collected from the flock by or under the supervision of an Authorized Agent, as described in § 147.12 of this subchapter, when the flock reaches 4 months of age and every 30 days thereafter. The environmental samples shall be examined bacteriologically for group D salmonella at an authorized laboratory, and cultures from group D positive samples shall be serotyped.
(v)Blood samples from 300 birds from the flock are officially tested with pullorum antigen when the flock is at least 4 months of age. All birds with positive or inconclusive reactions, up to a maximum of 25 birds, shall be submitted to an authorized laboratory and examined for the presence of group D salmonella in accordance with §§ 147.10 and 147.11 of this subchapter. Cultures from group D positive samples shall be serotyped.
(vi)Hatching eggs produced by the flock are collected as quickly as possible and are handled as described in § 147.22 of this subchapter.
(vii)Hatching eggs produced by the flock are incubated in a hatchery that is in compliance with the recommendations in §§ 147.23 and 147.24(b) of this subchapter, and the hatchery must have been sanitized either by a procedure approved by the Official State Agency or by fumigation.
(2)If *Salmonella enteritidis* serotype *enteritidis*
(SE)is isolated from a specimen taken from a bird in the flock, except as provided in paragraph (e)(3) of this section, the flock shall not be eligible for this classification.
(3)If SE is isolated from an environmental sample collected from the flock in accordance with paragraph (e)(1)(iv) of this section, 25 randomly selected live birds from the flock and/or 500 cloacal swabs collected in accordance with § 147.12(a)(2) of this subchapter must be bacteriologically examined for SE as described in § 147.11 of this subchapter. If only 1 bird from the 25-bird sample is found positive for SE, the participant may request bacteriological examination of a second 25-bird sample from the flock. If no SE is recovered from any of the specimens in the second sample, the flock will be eligible for the classification and will remain eligible for this classification if the flock is tested in accordance with paragraph (e)(1)(v) of this section each 30 days and no positive samples are found.
(4)In order for a hatchery to sell products of this classification, all products handled by the hatchery must meet the requirements of this paragraph.
(5)This classification may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures. The Official State Agency shall not revoke the participant's classification until the participant has been given an opportunity for a hearing in accordance with rules of practice adopted by the Official State Agency.
(6)A pedigree, experimental, or great-grandparent flock that is removed from the U.S. S. Enteritidis Clean program may be reinstated whenever the following conditions are met:
(i)The owner attests that corrective measures have been implemented, which may include one or more of the following:
(A)Test and slaughter infected birds based on blood tests of every bird in the flock, with either pullorum antigen or by a federally licensed *Salmonella enteritidis* enzyme-linked immunosorbent assay (ELISA) test when the flock is more than 4 months of age.
(B)Perform other corrective actions including, but not limited to, vaccination, medication, cleaning and disinfection of houses, rodent control, and movement of uninfected birds to premises that have been determined to be environmentally negative for *S. enteritidis* as described in § 147.12(a) of this subchapter.
(C)One hundred percent of blood samples from the birds moved to the clean premises are tested negative for *Salmonella pullorum* and group D *Salmonella.* All birds with positive or inconclusive reactions, up to a maximum of 25 birds, shall be submitted to an authorized laboratory and examined for the presence of group D *Salmonella,* as described in § 147.11 of this subchapter. Cultures from positive samples shall be serotyped.
(D)Two consecutive environmental drag swabs taken at the clean premises collected as specified in § 147.12(a) of this subchapter 4 weeks apart are negative for *S. enteritidis.*
(E)Other corrective measures at the discretion of the Official State Agency.
(ii)Following reinstatement, a flock will remain eligible for this classification if the flock is tested in accordance with paragraph (e)(1)(v) of this section every 30 days and no positive samples are found and the flock meets the requirements set forth in § 145.83(e).
(f)*U.S. Salmonella Monitored.* This program is intended to be the basis from which the breeding-hatching industry may conduct a program for the prevention and control of salmonellosis. It is intended to reduce the incidence of *Salmonella* organisms in hatching eggs and chicks through an effective and practical sanitation program at the breeder farm and in the hatchery. This will afford other segments of the poultry industry an opportunity to reduce the incidence of *Salmonella* in their products.
(1)A flock and the hatching eggs and chicks produced from it that have met the following requirements, as determined by the Official State Agency.
(i)The flock is maintained in compliance with §§ 147.21, 147.24(a), and 147.26 of this subchapter;
(ii)If feed contains animal protein, the protein products must have a minimum moisture content of 14.5 percent and must have been heated throughout to a minimum temperature of 190 °F or above, or to a minimum temperature of 165 °F for at least 20 minutes, or to a minimum temperature of 184 °F under 70 lbs. pressure during the manufacturing process;
(iii)Feed shall be stored and transported in a manner to prevent possible contamination;
(iv)Chicks shall be hatched in a hatchery meeting the requirements of §§ 147.23 and 147.24(b) of this subchapter and sanitized or fumigated (see § 147.25 of this subchapter).
(v)An Authorized Agent shall take environmental samples from the hatchery every 30 days; i.e., meconium or chick papers. An authorized laboratory for *Salmonella* shall examine the samples bacteriologically;
(vi)An Authorized Agent shall take environmental samples as described in § 147.12 of this subchapter from each flock at 4 months of age and every 30 days thereafter. An authorized laboratory for *Salmonella* shall examine the environmental samples bacteriologically;
(vii)Owners of flocks may vaccinate with a paratyphoid vaccine: *Provided,* That a sample of 350 birds, which will be banded for identification, shall remain unvaccinated until the flock reaches at least 4 months of age.
(2)The Official State Agency may use the procedures described in § 147.14 of this subchapter to monitor the effectiveness of the egg sanitation practices.
(3)In order for a hatchery to sell products of this classification, all products handled shall meet the requirements of the classification.
(4)This classification may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures.
(g)*U.S. Avian Influenza Clean.* This program is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of avian influenza. It is intended to determine the presence of avian influenza in primary breeding chickens through routine serological surveillance of each participating breeding flock. A flock and the hatching eggs and chicks produced from it will qualify for this classification when the Official State Agency determines that they have met the following requirements:
(1)It is a primary breeding flock in which a minimum of 30 birds have been tested negative for antibodies to avian influenza when more than 4 months of age and prior to the onset of egg production. To retain this classification:
(i)A sample of at least 30 birds must be tested negative at intervals of 90 days; *Provided,* that primary spent fowl be tested within 30 days prior to movement to slaughter; or
(ii)A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds is tested within each 90-day period.
(2)[Reserved] PART 147—AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN 20. The authority citation for part 147 continues to read as follows: Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4. § 147.7 [Amended] 21. In § 147.7, paragraph (b)(1)(vii), the citation “§ 147.6” is removed and the citation “§ 147.6(a)” is added in its place. 22. Section 147.11 is amended as follows: a. In paragraph (a), by revising the introductory text to read as set forth below. b. By removing and reserving paragraph (b). § 147.11 Laboratory procedure recommended for the bacteriological examination of salmonella.
(a)*For egg- and meat-type chickens, turkeys, waterfowl, exhibition poultry, and game birds.* All reactors to the pullorum-typhoid tests, up to 25 birds, and birds from *Salmonella enteritidis*
(SE)positive environments should be cultured in accordance with both the direct enrichment (paragraph (a)(1)) and selective enrichment (paragraph (a)(2)) procedures described in this section: *Provided,* That in turkeys, if there are more than four reactors to the pullorum-typhoid tests in the flock, a minimum of four reactors as provided for in § 145.14(a)(6)(ii) of this subchapter shall be submitted to the authorized laboratory for bacteriological examination. Careful aseptic technique should be used when collecting all tissue samples. § 147.12 [Amended] 23. In § 147.12, paragraph (b)(3) is amended by adding the words “using a PCR-based assay approved by the NPIP under § 145.15” after the word “enrichment”. 24. Section 147.17 is amended as follows: a. By revising the section heading, the introductory text of the section, and paragraphs
(a)and
(c)to read as set forth below. b. In paragraph (d), by removing the number “15”. § 147.17 Laboratory procedure recommended for the bacteriological examination of cull chicks and poults for salmonella. The laboratory procedure described in this section is recommended for the bacteriological examination of cull chicks from egg-type and meat-type chicken flocks and waterfowl, exhibition poultry, and game bird flocks and poults from turkey flocks for salmonella.
(a)For cull chicks, from 25 randomly selected 1- to 5-day-old chicks that have not been placed in a brooding house, prepare 5 organ pools, 5 yolk pools, and 5 intestinal tissue pools as follows. For poults, from a sample of 10 poults that died within 10 days after hatching, prepare organ pools, yolk pools, and intestinal pools as follows:
(1)*Organ pool:* From each of five chicks or two poults, composite and mince 1- to 2-gram samples of heart, lung, liver, and spleen tissues. Include the proximal wall of the bursa of Fabricius for chicks only.
(2)*Yolk pool:* From each of five chicks or two poults, composite and mince 1- to 2-gram samples of the unabsorbed yolk sac or, if the yolk sac is essentially absent, the entire yolk stalk remnant.
(3)*Intestinal pool:* From each of five chicks or two poults, composite and mince approximately 0.5 cm 2 sections of the crop wall and 5-mm-long sections of the duodenum, cecum, and ileocecal junction.
(c)For cull chicks, repeat the steps in paragraphs
(a)and
(b)of this section for each 5-chick group until all 25 chicks have been examined, producing a total of 15 pools (5 organ, 5 yolk, and 5 intestinal). For poults, repeat the steps in paragraphs
(a)and
(b)of this section for each two-poult group until all the poults in the sample have been examined. 25. A new subpart D is added to read as set forth below. Subpart D—Molecular Examination Procedures § 147.30 Laboratory procedure recommended for the polymerase chain reaction
(PCR)test for Mycoplasma gallisepticum and M. synoviae.
(a)*DNA isolation.* Isolate DNA from 1 mL of eluate from tracheal swabs in PBS or 1 mL of broth culture by a non-phenolic procedure. Centrifuge samples at 14,000 x g for 5 to 10 minutes. Decant supernatant and wash the pellet with 1 mL of PBS. Centrifuge as above and re-suspend the pellet in 25-50 μl of 0.1 percent DEP (Diethyl Pyrocarbonate; Sigma) water. Boil at 120 °C for 10 minutes followed by 10 minutes incubation at 4 °C. Centrifuge as above and transfer the supernatant DNA to a nuclease-free tube. Estimate the DNA concentration and purity by spectrophotometric reading at 260 nm and 280 nm.
(b)*Primer selection.*
(1)*M. gallisepticum.* The primer for *M. gallisepticum* should consist of the following sequences: ER12JA07.004
(2)*M. synoviae.* The primer for *M. synoviae* should consist of the following sequences: ER12JA07.005
(c)*Polymerase chain reaction.*
(1)Treat each sample (100 to 2000 ng/5 μl) with one of the following 45 μl PCR cocktails:
(i)5 μl 10x PCR buffer, 1 μl dNTP (10 mM), 1 μl of Reverse primer (50 μM), 1 μl of Forward primer (50 μM), 4 μl MgCl <sup>2</sup> (25 mM), 1 μl taq-polymerase (5 U), 32 μl DEP water.
(ii)18 μl water, 25 μl PCR mix (Promega), 1 μl Reverse primer (50 μM), 1 μl Forward primer (50 μM).
(2)Perform DNA amplification in a Perkin-Elmer 9600 thermocycler or in a Hybaid PCR Express thermocycler. 24 The optimized PCR program is as follows: 24 Trade names are used in these procedures solely for the purpose of providing specific information. Mention of a trade name does not constitute a guarantee or warranty of the product by the U.S. Department of Agriculture or an endorsement over other products not mentioned. Temperature (°C) Duration Cycles 94 30 seconds 30-40. 55 30 seconds 30-40. 72 1 minute 30-40. 72 5 minutes 1 (final extension).
(d)*Electrophoresis.* Mix PCR products (5 to 10 μl) with 2 μl loading buffer (Sigma) and electrophorese on a 2 percent agarose gel containing 0.5 μg/mL ethidium bromide in TAE buffer (40 mM tris; 2 mM EDTA; pH 8.0 with glacial acetic acid) for 30 minutes at 80 V. *M. gallisepticum* (185 bp) and *M. synoviae* (214 bp) amplicons can be visualized under an ultraviolet transilluminator along with the PCR marker (50 to 2000 bp; Sigma). Done in Washington, DC, this 28th day of December 2006. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E6-22635 Filed 1-11-07; 8:45 am] BILLING CODE 3410-34-P NUCLEAR REGULATORY COMMISSION 10 CFR Part 110 RIN 3150-AI02 Export and Import of Nuclear Material; Exports to Libya Restricted AGENCY: Nuclear Regulatory Commission. ACTION: Final rule. SUMMARY: The Nuclear Regulatory Commission
(NRC)is amending its export/import regulations by moving Libya from the list of embargoed destinations to the list of restricted destinations. This amendment is necessary to conform NRC's regulations with U.S. Government foreign policy. DATES: The final rule is effective January 12, 2007. ADDRESSES: Publicly available documents related to this rulemaking may be viewed electronically on the public computers located at the NRC's Public Document Room (PDR), Public File Area O1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland. The PDR reproduction contractor will copy documents for a fee. Selected documents, including comments can be viewed and downloaded electronically via the NRC's rulemaking Web site at *http://ruleforum.llnl.gov.* Publicly available documents created or received at the NRC are available electronically at the NRC's Electronic Reading Room at *http://www.nrc.gov/NRC/reading-rm/adams.html.* From this site, the public can gain entry into the NRC's Agencywide Document Access and Management System (ADAMS), which provides text and image files of NRC's public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC Public Document Room
(PDR)Reference staff at 1-800-397-4209, 301-415-4737 or by e-mail to *PDR@nrc.gov.* FOR FURTHER INFORMATION CONTACT: Jennifer Schwartzman, International Relations Specialist, Office of International Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone 301-415-2317, e-mail *jks1@nrc.gov,* or Brooke G. Smith, International Policy Analyst, Office of International Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone 301-415-2347, e-mail *bgs@nrc.gov.* SUPPLEMENTARY INFORMATION: The purpose of this final rule is to revise the NRC's export/import regulations in 10 CFR Part 110, “Export and Import of Nuclear Equipment and Material,” with regard to Libya in light of the June 30, 2006 rescission by the Secretary of State of Libya's designation as a State Sponsor of Terrorism. Libya was designated as a State Sponsor of Terrorism in 1979. The Executive Branch has recommended that, in light of the rescission of the designation, 10 CFR Part 110 should be amended by moving Libya from the embargoed destinations list to the restricted destinations list. This rule moves Libya from the embargoed destinations list for exports in 10 CFR 110.28 to the restricted destinations list in 10 CFR 110.29. This means that exports to Libya of small quantities of certain nuclear materials and byproduct materials may qualify for the NRC general license specified in §§ 110.21 through 110.24. The NRC staff has determined that moving Libya from the embargoed list to the restricted list is consistent with current U.S. law and policy, and will pose no unreasonable risk to the public health and safety or to the common defense and security of the United States. Because this rule involves a foreign affairs function of the United States, the notice and comment provisions of the Administrative Procedure Act do not apply (5 U.S.C. 553(a)(1)). This rule will become effective immediately upon publication. Voluntary Consensus Standards The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) requires that Federal Agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless using such a standard is inconsistent with applicable law or otherwise impractical. This final rule does not constitute the establishment of a standard for which the use of a voluntary consensus standard would be applicable. Environmental Impact: Categorical Exclusion The NRC has determined that this final rule is the type of action described in categorical exclusion 10 CFR 51.22(c)(1). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for the rule. Paperwork Reduction Act Statement This final rule does not contain new or amended information collection requirements subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). Existing requirements were approved by the Office of Management and Budget (OMB), approval number 3150-0036. Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number. Regulatory Analysis The NRC currently controls exports to Libya as an embargoed destination in section 110.28. There is no alternative to amending the regulations for the export and import of nuclear equipment and materials. This final rule would not result in any increase or cost to the public. Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980, (5 U.S.C. 605(b)), the Commission certifies that this final rule will not have a significant economic impact on a substantial number of small entities. This rule affects only companies exporting nuclear equipment and materials to Libya which do not fall within the scope of the definition of “small entities” set forth in the Regulatory Flexibility Act (5 U.S.C. 601(3)), or the Size Standards established by the NRC (10 CFR 2.810). Backfit Analysis The NRC has determined that a backfit analysis is not required for this rule because these amendments do not include any provisions that would impose backfits as defined in 10 CFR Chapter I. Congressional Review Act Under the Congressional Review Act of 1996, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of OMB. List of Subjects in 10 CFR Part 110 Administrative practice and procedure, Classified information, Criminal penalties, Export, Import, Intergovernmental relations, Nuclear materials, Nuclear power plants and reactors, Reporting and recordkeeping requirements, Scientific equipment. For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR part 110. PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL 1. The authority citation for part 110 continues to read as follows: Authority: Secs. 51, 53, 54, 57, 63, 64, 65, 81, 82, 103, 104, 109, 111, 126, 127, 128, 129, 161, 181, 182, 187, 189, 68 Stat. 929, 930, 931, 932, 933, 936, 937, 948, 953, 954, 955, 956, as amended (42 U.S.C. 2071, 2073, 2074, 2077, 2092-2095, 2111, 2112, 2133, 2134, 2139, 2139a, 2141, 2154-2158, 2201, 2231-2233, 2237, 2239); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841; sec. 5, Pub. L. 101-575, 104 Stat. 2835 (42 U.S.C. 2243); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note). Sections 110.1(b)(2) and 110.1(b)(3) also issued under Pub. L. 96-92, 93 Stat. 710 (22 U.S.C. 2403). Section 110.11 also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152) and secs. 54c and 57d, 88 Stat. 473, 475 (42 U.S.C. 2074). Section 110.27 also issued under sec. 309(a), Pub. L. 99-440. Section 110.50(b)(3) also issued under sec. 123, 92 Stat. 142 (42 U.S.C. 2153). Section 110.51 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Section 110.52 also issued under sec. 186, 68 Stat. 955 (42 U.S.C. 2236). Sections 110.80-110.113 also issued under 5 U.S.C. 552, 554. Sections 110.30-110.135 also issued under 5 U.S.C. 553. Sections 110.2 and 110.42(a)(9) also issued under sec. 903, Pub. L. 102-496 (42 U.S.C. 2151 *et seq.* ). § 110.28 [Amended] 2. Section 110.28 is amended by removing “Libya” from the list of embargoed destinations. § 110.29 [Amended] 3. Section 110.29 is amended by adding “Libya” to the list of restricted destinations in alphabetical order. Dated at Rockville, Maryland, this 29th day of December, 2006. For the Nuclear Regulatory Commission. Jacqueline E. Silber, Acting Executive Director for Operations. [FR Doc. E7-320 Filed 1-11-07; 8:45 am] BILLING CODE 7590-01-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-26811; Directorate Identifier 2006-NM-262-AD; Amendment 39-14887; AD 2007-01-15] RIN 2120-AA64 Airworthiness Directives; Boeing Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747SR, and 747SP Series Airplanes Equipped with General Electric CF6-45 or -50 Series Engines, or Equipped with Pratt & Whitney JT9D-3 or -7 (Excluding -70) Series Engines AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule; request for comments. SUMMARY: The FAA is superseding an existing airworthiness directive
(AD)that applies to certain Boeing Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747SR, and 747SP series airplanes. The existing AD currently requires repetitive inspections to detect cracks and fractures of the strut front spar chord assembly at each strut location, and repair if necessary. This new AD expands the inspection area by requiring repetitive inspections for any cracks or fracture of the strut front spar chord assembly in an area forward of the existing inspection area at each strut location, and repair if necessary. This AD results from a strut front spar chord assembly that was found fractured, forward of the inspection area required by the existing AD. We are issuing this AD to detect and correct cracks and fracture of the nacelle strut front spar chord assembly. Fracture of the front spar chord assembly could lead to loss of the strut upper link load path and consequent fracture of the diagonal brace, which could result in in-flight separation of the strut and engine from the airplane. DATES: This AD becomes effective January 29, 2007. The Director of the Federal Register approved the incorporation by reference of a certain publication listed in the AD as of January 29, 2007. On December 27, 2004 (69 FR 71349, December 9, 2004), the Director of the Federal Register approved the incorporation by reference of Boeing Alert Service Bulletin 747-54A2224, dated September 30, 2004. We must receive any comments on this AD by March 13, 2007. ADDRESSES: Use one of the following addresses to submit comments on this AD. • *DOT Docket Web site:* Go to *http://dms.dot.gov* and follow the instructions for sending your comments electronically. • *Government-wide rulemaking Web site:* Go to *http://www.regulations.gov* and follow the instructions for sending your comments electronically. • *Mail:* Docket Management Facility; U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC 20590. • *Fax:*
(202)493-2251. • *Hand Delivery:* Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207, for service information identified in this AD. You may examine the contents of the AD docket on the Internet at *http://dms.dot.gov* , or in person at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Room PL-401, Washington, DC. This docket number is FAA-2007-26811; the directorate identifier for this docket is 2006-NM-262-AD. FOR FURTHER INFORMATION CONTACT: Ivan Li, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)917-6437; fax
(425)917-6590. SUPPLEMENTARY INFORMATION: Discussion On November 30, 2004, we issued AD 2004-25-05, amendment 39-13893 (69 FR 71349, December 9, 2004). That AD applies to certain Boeing Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747SR, and 747SP series airplanes. That AD requires repetitive inspections to detect cracks and fractures of the strut front spar chord assembly at each strut location, and repair if necessary. That AD resulted from a report of a fractured front spar chord assembly for strut No. 3, which resulted in the loss of the strut upper link load path. The actions specified in that AD are intended to prevent loss of the strut upper link load path and consequent fracture of the diagonal brace, which could result in in-flight separation of the strut and engine from the airplane. Actions Since AD Was Issued Since we issued AD 2004-25-05, we have received a report that the front spar chord assembly for strut No. 3 was found fractured on a Boeing Model 747-200 series airplane equipped with General Electric
(GE)CF6-50E series engines. The fracture was located forward of the inspection area required by AD 2004-25-05. The airplane had accumulated about 79,800 total flight hours and 15,100 total flight cycles. (Since strut modification, the airplane had accumulated about 9,800 flight cycles and 48,200 flight hours.) We have determined that the inspection area required by AD 2004-25-05 must be expanded to adequately detect and correct cracks and fracture of the nacelle strut front spar chord assembly. Fracture of the front spar chord assembly could lead to loss of the strut upper link load path and consequent fracture of the diagonal brace, which could result in in-flight separation of the strut and engine from the airplane. Relevant Service Information We have reviewed Boeing Alert Service Bulletin 747-54A2224, Revision 1, dated November 16, 2006. The Accomplishment Instructions of the service bulletin are divided into two parts: Part 1—Aft Side Inspection and Part 2—Forward Side Inspection. Part 1 describes procedures for accomplishing detailed and high frequency eddy current
(HFEC)inspections for any cracks or fracture of the front spar chord assembly for strut Nos. 1, 2, 3, and 4. For struts carrying Pratt & Whitney JT9D-3 or -7 (excluding -70) series engines and inboard struts carrying GE CF6-45 or -50 series engines, the inspection area is aft of the rear engine mount bulkhead. For outboard struts carrying GE CF6-45 or -50 series engines, the inspection area is aft of the strut station 270 bulkhead. (Part 1 contains the same procedures as those described in the original issue of the service bulletin, dated September 30, 2006, which we referred to as the appropriate source of service information for AD 2004-25-05.) Part 2 describes procedures for accomplishing detailed and HFEC inspections for any cracks or fracture of the front spar chord assembly for strut Nos. 1, 2, 3, and 4, forward of the rear engine mount bulkhead or strut station 270 bulkhead, as applicable. The Part 2 inspections include inspecting in areas adjacent to the frame, around certain fasteners, and on the front spar chord radius. If any crack or fracture is found, Part 1 and Part 2 specify to contact Boeing for additional instructions and repair. FAA's Determination and Requirements of This AD The unsafe condition described previously is likely to exist or develop on other airplanes of the same type design. For this reason, we are issuing this AD to supersede AD 2004-25-05. This new AD retains the requirements of the existing AD. This AD also requires repetitive inspections for any cracks or fracture of the strut front spar chord assembly forward of the bulkhead at each strut location, and repair if necessary, except as discussed under “Difference Between the AD and Service Bulletin.” Difference Between the AD and Service Bulletin The service bulletin specifies to contact the manufacturer for instructions on how to repair certain conditions, but this AD requires repairing those conditions in one of the following ways: • Using a method that we approve; or • Using data that meet the certification basis of the airplane, and that have been approved by an Authorized Representative for the Boeing Commercial Airplanes Delegation Option Authorization Organization whom we have authorized to make those findings. Change to Existing AD This AD retains all requirements of AD 2004-25-05. Since AD 2004-25-05 was issued, the AD format has been revised, and certain paragraphs have been rearranged. As a result, the corresponding paragraph identifiers have changed in this AD, as listed in the following table: Revised Paragraph Identifiers Requirement in AD 2004-25-05 Corresponding requirement in this AD Paragraph
(b)Paragraph (c). Paragraph
(c)Paragraph (d). Paragraph
(d)Paragraph (e). Paragraph
(e)Paragraph (f). Paragraph
(f)Paragraph (g). Paragraph
(g)Paragraph (h). Paragraph
(h)Paragraph (i). Explanation of Change Made to This AD Boeing Commercial Airplanes has received a Delegation Option Authorization (DOA). We have revised paragraph
(i)of this AD to delegate the authority to approve an alternative method of compliance for any repair required by this AD to an Authorized Representative for the Boeing Commercial Airplanes DOA, rather than a Designated Engineering Representative (DER). Clarification of Alternative Method of Compliance
(AMOC)Paragraph We have revised this action to clarify the appropriate procedure for notifying the principal inspector before using any approved AMOC on any airplane to which the AMOC applies. Interim Action This is considered to be interim action. The manufacturer has advised that it currently is developing a modification that will address the unsafe condition addressed by this AD. Once this modification is developed, approved, and available, the FAA may consider additional rulemaking. FAA's Determination of the Effective Date An unsafe condition exists that requires the immediate adoption of this AD; therefore, providing notice and opportunity for public comment before the AD is issued is impracticable, and good cause exists to make this AD effective in less than 30 days. Comments Invited This AD is a final rule that involves requirements that affect flight safety and was not preceded by notice and an opportunity for public comment; however, we invite you to submit any relevant written data, views, or arguments regarding this AD. Send your comments to an address listed in the ADDRESSES section. Include “Docket No. FAA-2007-26811; Directorate Identifier 2006-NM-262-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the AD that might suggest a need to modify it. We will post all comments we receive, without change, to *http://dms.dot.gov* , including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this AD. Using the search function of that Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477-78), or you may visit *http://dms.dot.gov* . Examining the Docket You may examine the AD docket on the Internet at *http://dms.dot.gov* , or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone
(800)647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System receives them. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. 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. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect 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. For the reasons discussed above, I certify that the regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration
(FAA)amends § 39.13 by removing amendment 39-13893 (69 FR 71349, December 9, 2004) and adding the following new airworthiness directive (AD): **2007-01-15 BOEING:** Docket No. FAA-2007-26811; Directorate Identifier 2006-NM-262-AD; Amendment 39-14887. Effective Date
(a)This AD becomes effective January 29, 2007. Affected ADs
(b)This AD supersedes AD 2004-25-05. Applicability
(c)This AD applies to Boeing Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747SR, and 747SP series airplanes, certificated in any category, as identified in Boeing Alert Service Bulletin 747-54A2224, Revision 1, dated November 16, 2006. Unsafe Condition
(d)This AD results from a strut front spar chord assembly that was found fractured, forward of the inspection area required by AD 2004-25-05. We are issuing this AD to detect and correct cracks and fracture of the nacelle strut front spar chord assembly. Fracture of the front spar chord assembly could lead to loss of the strut upper link load path and consequent fracture of the diagonal brace, which could result in in-flight separation of the strut and engine from the airplane. Compliance
(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Restatement of Requirements of AD 2004-25-05 Aft Side Detailed and High Frequency Eddy Current
(HFEC)Inspections With New Service Information
(f)Within 90 days after December 27, 2004 (the effective date of AD 2004-25-05), perform detailed and HFEC inspections to detect any cracks or fractures of the front spar chord assembly for strut numbers 1 through 4 inclusive, in accordance with Boeing Alert Service Bulletin 747-54A2224, dated September 30, 2004; or in accordance with Part 1—Aft Side Inspection of the Accomplishment Instructions of Boeing Alert Service Bulletin 747-54A2224, Revision 1, dated November 16, 2006. As of the effective date of this AD, only Part 1—Aft Side Inspection of the Accomplishment Instructions of Revision 1 of the service bulletin may be used.
(g)Accomplishment of the detailed and HFEC inspections in accordance with Boeing 747 Fleet Team Digest 747-FTD-54-04002, dated April 15, 2004, May 4, 2004, June 1, 2004, July 12, 2004, or July 28, 2004; or Boeing Message 1-C6ELC (Service Request ID No.: 218724992), dated April 14, 2004; before December 27, 2004, is considered acceptable for compliance with the requirements of paragraph
(f)of this AD. Repetitive Inspections
(h)For airplanes on which no crack or fracture is detected during the inspections required by paragraph
(f)of this AD: At the applicable times specified in Table 1—Repetitive Intervals of this AD, repeat the detailed and HFEC inspections required by paragraph
(f)of this AD. Table 1.—Repetitive Intervals For airplanes identified in Boeing Alert Service Bulletin 747-54A2224, dated September 30, 2004; or Revision 1, dated November 16, 2006; as— Repeat the inspections at intervals not to exceed— Group 1 1,000 flight cycles or 18 months, whichever occurs first. Group 2 and Group 3 1,200 flight cycles or 18 months, whichever occurs first. Group 4 and Group 6 1,500 flight cycles or 18 months, whichever occurs first. Group 5 2,000 flight cycles or 18 months, whichever occurs first. Corrective Action
(i)If any crack or fracture is found during any inspection required by paragraphs
(f)and
(h)of this AD, and the bulletin specifies contacting Boeing for appropriate action: Before further flight, repair the crack or fracture according to a method approved by the Manager, Seattle Aircraft Certification Office (ACO), FAA; or using a method approved in accordance with the procedures specified in paragraph
(m)of this AD. For a repair method to be approved, the approval must specifically reference this AD. New Requirements of This Ad Forward Side Detailed and HFEC Inspections
(j)Within 90 days after the effective date of this AD, do detailed and HFEC inspections for any cracks or fracture of the front spar chord assembly for strut numbers 1, 2, 3, and 4, in accordance with Part 2—Forward Side Inspection of the Accomplishment Instructions of Boeing Alert Service Bulletin 747-54A2224, Revision 1, dated November 16, 2006. If no crack or fracture is found, repeat the inspections thereafter at the applicable interval specified in Table 1 of this AD. Corrective Action for Forward Side Inspection
(k)If any crack or fracture is found during any inspection required by paragraph
(j)of this AD, and Boeing Alert Service Bulletin 747-54A2224, Revision 1, dated November 16, 2006, specifies to contact Boeing for appropriate action: Before further flight, repair the crack or fracture using a method approved in accordance with the procedures specified in paragraph
(m)of this AD. Credit for Inspections Done According to Boeing 747 Fleet Team Digest
(l)Detailed and HFEC inspections done before the effective date of this AD in accordance with Boeing 747 Fleet Team Digest 747-FTD-54-06002, dated June 29, 2006; or October 16, 2006; are acceptable for compliance with the initial inspection required by paragraph
(j)of this AD. Alternative Methods of Compliance (AMOCs) (m)(1) The Manager, Seattle ACO, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(2)Before using any AMOC approved in accordance with § 39.19 on any airplane to which the AMOC applies, notify the appropriate principal inspector in the FAA Flight Standards Certificate Holding District Office.
(3)An AMOC that provides an acceptable level of safety may be used for any repair required by this AD, if it is approved by an Authorized Representative for the Boeing Commercial Airplanes Delegation Option Authorization Organization who has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD. Material Incorporated by Reference
(n)You must use Boeing Alert Service Bulletin 747-54A2224, dated September 30, 2004; and Boeing Alert Service Bulletin 747-54A2224, Revision 1, dated November 16, 2006; as applicable; to perform the actions that are required by this AD, unless the AD specifies otherwise.
(1)The Director of the Federal Register approved the incorporation by reference of Boeing Alert Service Bulletin 747-54A2224, Revision 1, dated November 16, 2006, in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
(2)On December 27, 2004 (69 FR 71349, December 9, 2004), the Director of the Federal Register approved the incorporation by reference of Boeing Alert Service Bulletin 747-54A2224, dated September 30, 2004.
(3)Contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207, for a copy of this service information. You may review copies at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Room PL-401, Nassif Building, Washington, DC; on the Internet at *http://dms.dot.gov* ; or at the National Archives and Records Administration (NARA). For information on the availability of this material at the NARA, call
(202)741-6030, or go to *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html* . Issued in Renton, Washington, on December 26, 2006. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-220 Filed 1-11-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2005-22559; Directorate Identifier 2005-NM-076-AD; Amendment 39-14879; AD 2007-01-07] RIN 2120-AA64 Airworthiness Directives; Bombardier Model CL-600-2B19 (Regional Jet Series 100 & 440) Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule. SUMMARY: The FAA is superseding an existing airworthiness directive (AD), that applies to certain Bombardier Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. That AD currently requires repetitive inspections for cracks, sealant damage, and corrosion of the main fittings of the main landing gear (MLG), and corrective actions if necessary. This new AD reduces the compliance times for inspecting certain low-utilization airplanes, and provides a terminating action for the repetitive inspections. This AD results from a report of a cracked main fitting of the MLG. We are issuing this AD to detect and correct fatigue cracking of the main fitting of the MLG and consequent failure of the main fitting, which could result in the collapse of the MLG. DATES: This AD becomes effective February 16, 2007. The Director of the Federal Register approved the incorporation by reference of certain publications listed in the AD as of February 16, 2007. On October 21, 2004 (69 FR 59790, October 6, 2004), the Director of the Federal Register approved the incorporation by reference of Bombardier Alert Service Bulletin A601R-32-099, including Appendices A, B, and D, and excluding Appendix C, dated September 15, 2004. ADDRESSES: You may examine the AD docket on the Internet at *http://dms.dot.gov* or in person at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC. Contact Bombardier, Inc., Canadair, Aerospace Group, P.O. Box 6087, Station Centre-ville, Montreal, Quebec H3C 3G9, Canada, for service information identified in this AD. FOR FURTHER INFORMATION CONTACT: Richard Beckwith, Aerospace Engineer, Airframe and Propulsion Branch, ANE-171, FAA, New York Aircraft Certification Office, 1600 Stewart Avenue, suite 410, Westbury, New York 11590; telephone
(516)228-7302; fax
(516)794-5531. SUPPLEMENTARY INFORMATION: Examining the Docket You may examine the airworthiness directive
(AD)docket on the Internet at *http://dms.dot.gov* or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone
(800)647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section. Discussion The FAA issued a notice of proposed rulemaking
(NPRM)to amend 14 CFR part 39 to include an AD that supersedes AD 2004-20-09, amendment 39-13814 (69 FR 59790, October 6, 2004). The existing AD applies to certain Bombardier Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. That NPRM was published in the **Federal Register** on July 12, 2006 (71 FR 39237). That NPRM proposed to continue to require repetitive inspections for cracks, sealant damage, and corrosion of the main fittings of the main landing gear (MLG), and corrective actions if necessary. That NPRM also proposed to reduce the compliance times for inspecting certain low-utilization airplanes, and to provide a terminating action for the repetitive inspections. Comments We provided the public the opportunity to participate in the development of this AD. We have considered the comments that have been received on the NPRM. Request To Change Incorporation of Certain Information The Modification and Replacement Parts Association (MARPA) states that, typically, airworthiness directives are based on service information originating with the type certificate holder or its suppliers. MARPA adds that manufacturer service documents are privately authored instruments generally having copyright protection against duplication and distribution. MARPA notes that when a service document is incorporated by reference into a public document, such as an airworthiness directive, it loses its private, protected status and becomes a public document. MARPA adds that if a service document is used as a mandatory element of compliance, it should not simply be referenced, but should be incorporated into the regulatory document; by definition, public laws must be public, which means they cannot rely upon private writings. MARPA is concerned that the failure to incorporate essential service information could result in a court decision invalidating the AD. MARPA adds that incorporated by reference service documents should be made available to the public by publication in the Docket Management System (DMS), keyed to the action that incorporates them. MARPA notes that the stated purpose of the incorporation by reference method is brevity, to keep from expanding the **Federal Register** needlessly by publishing documents already in the hands of the affected individuals; traditionally, “affected individuals” means aircraft owners and operators, who are generally provided service information by the manufacturer. MARPA adds that a new class of affected individuals has emerged, since the majority of aircraft maintenance is now performed by specialty shops instead of aircraft owners and operators. MARPA notes that this new class includes maintenance and repair organizations, component servicing and repair shops, parts purveyors and distributors, and organizations manufacturing or servicing alternatively certified parts under section 21.303 (“Parts Manufacturer Approval”) of the Federal Aviation Regulations (14 CFR part 21). MARPA adds that the concept of brevity is now nearly archaic as documents exist more frequently in electronic format than on paper. Therefore, MARPA asks that the service documents deemed essential to the accomplishment of the NPRM be incorporated by reference into the regulatory instrument, and published in the DMS. We understand MARPA's comment concerning incorporation by reference. The Office of the Federal Register
(OFR)requires that documents that are necessary to accomplish the requirements of the AD be incorporated by reference during the final rule phase of rulemaking. This final rule incorporates by reference the documents necessary for the accomplishment of the requirements mandated by this AD. Further, we point out that while documents that are incorporated by reference do become public information, they do not lose their copyright protection. For that reason, we advise the public to contact the manufacturer to obtain copies of the referenced service information. Additionally, we do not publish service documents in DMS. We are currently reviewing our practice of publishing proprietary service information. Once we have thoroughly examined all aspects of this issue, and have made a final determination, we will consider whether our current practice needs to be revised. However, we consider that to delay this AD action for that reason would be inappropriate, since we have determined that an unsafe condition exists and that the requirements in this AD must be accomplished to ensure continued safety. Therefore, we have not changed the AD in this regard. Request To Reference Parts Manufacturer Approval
(PMA)Parts MARPA also states that type certificate holders in their service documents typically ignore the possible existence of PMA parts. MARPA states that this is particularly true with foreign manufacturers where the concept may not exist or be implemented in the country of origin. MARPA points out that the service document upon which an airworthiness directive is based frequently will require removing a certain part-numbered part and installing a different part-numbered part as a corrective action. According to MARPA, this runs afoul of section 21.303, which permits the development, certification, and installation of alternatively certified parts. MARPA further states that installing a certain part-numbered part to the exclusion of all other parts is not a favored general practice. MARPA states that such an action has the dual effect of preventing, in some cases, the installation of a perfectly good part; while at the same time prohibiting the development of new parts permitted under section 21.303. According to MARPA, such a prohibition runs the risk of taking the AD out of the realm of safety and into the world of economics, since prohibiting the development, sale, and use of a perfectly airworthy part has nothing to do with safety. MARPA states that courts could easily construe such actions as being outside the statutory basis of the AD (safety) and, as such, unenforceable. MARPA adds that courts are reluctant to find portions of a rule unenforceable since they lack the knowledge and authority to re-write requirements, and are thus generally inclined to simply void the entire rule. In response to the commenter's statement regarding running afoul of section 21.303, under which the FAA issues PMAs, this statement appears to reflect a misunderstanding of the relationship between ADs and the certification procedural regulations of 14 CFR part 21. Those regulations, including section 21.303, are intended to ensure that aeronautical products comply with the applicable airworthiness standards. But ADs are issued when, notwithstanding those procedures, we become aware of unsafe conditions in these products or parts. Therefore, an AD takes precedence over design approvals when we identify an unsafe condition, and mandating installation of a certain part number in an AD is not at variance with section 21.303. The AD provides a means of compliance for operators to ensure that the identified unsafe condition is addressed appropriately. For an unsafe condition attributable to a part, the AD normally identifies the replacement parts necessary to obtain that compliance. As stated in section 39.7 of the Federal Aviation Regulations (14 CFR 39.7), “Anyone who operates a product that does not meet the requirements of an applicable airworthiness directive is in violation of this section.” Unless an operator obtains approval for an alternative method of compliance (AMOC), replacing a part with one not specified by the AD would make the operator subject to an enforcement action and result in a civil penalty. No change to the AD is necessary in this regard. Request To Stop Using AMOC MARPA also believes that the practice of requiring an AMOC to install a PMA part should be stopped. MARPA states that this is somehow tantamount to stating, illogically, that all PMA parts are inherently defective and require an additional layer of approval when the original equipment manufacturer
(OEM)part is determined to be defective. MARPA suspects that the FAA personnel who labored diligently to certify the PMA part might disagree with such a narrow, OEM-slanted view. MARPA states that if the PMA part is defective, then it must be deemed so in the AD, and not simply implied by a catch-all AMOC requirement. MARPA states that this is why it has repeatedly requested that we adopt language to trap such defective parts, and suggests that the FAA's Transport Airplane Directorate adopt the language used by the Small Airplane Directorate to accomplish this. We infer that MARPA would like the AD to permit installation of any equivalent PMA parts so that it is not necessary for an operator to request approval of an AMOC in order to install an “equivalent” PMA part. Whether an alternative part is “equivalent” in adequately resolving the unsafe condition can only be determined on a case-by-case basis based on a complete understanding of the unsafe condition. The Transport Airplane Directorate's policy is that, in order for operators to replace a part with one that is not specified in the AD, they must request an AMOC. This is necessary so that we can make a specific determination that an alternative part is or is not susceptible to the same unsafe condition. No change to the AD is necessary in this regard. Request for Compliance With FAA Order 8040.2/Agreement on Parts Replacement MARPA points out that this AD, as written, does not comply with proposed Order 8040.2 (AD Process for Mandatory Continuing Airworthiness Information (MCAI)), which states in the PMA section: “MCAI that require replacement or installation of certain parts could have replacement parts approved under 14 CFR § 21.303 based on a finding of identicality. We have determined that any parts approved under this regulation and installed should be subject to the actions of our AD and included in the applicability of our AD.” MARPA points out that the Small Airplane Directorate has developed a blanket statement that resolves this issue. The statement includes words similar to those in the proposed Order 8040.2. MARPA also points out that the Engine and Rotocraft Directorates avoid the issue by specifying “airworthy parts” be installed, leaving the determination of exactly which parts to the discretion of the installer. MARPA further states that because the NPRM differs markedly in treatment of this issue from that of the other directorates, the mandates contained in Section 1, paragraph (b)(10) of Executive Order 12866 are not being met. This paragraph requires that all agencies act uniformly on a given issue. MARPA therefore requests that we take steps to bring the universe of PMA parts under the appropriate scope of this AD both with respect to possible defective PMA parts and the use of possible present or future approved parts. The NPRM did not address PMA parts, as provided in draft FAA Order 8040.2, because the Order was only a draft that was out for comment at the time. After issuance of the NPRM, the Order was revised and issued as FAA Order 8040.5 with an effective date of September 29, 2006. FAA Order 8040.5 does not address PMA parts in ADs. We acknowledge the need to ensure that unsafe PMA parts are identified and addressed in MCAI-related ADs. We are currently examining all aspects of this issue, including input from industry. Once we have made a final determination, we will consider how our policy regarding PMA parts in ADs needs to be revised. We consider that to delay this AD action would be inappropriate, since we have determined that an unsafe condition exists and that replacement of certain parts must be accomplished to ensure continued safety. Therefore, no change has been made to the final rule in this regard. Clarification of Paragraphs
(i)and
(k)of the Final Rule We have changed paragraphs
(i)and
(k)of the final rule to specify more clearly if operators choose to do the terminating action after finding a crack indication, the terminating action must be done before further flight. Conclusion We have carefully reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD. Costs of Compliance The following table provides the estimated costs for U.S. operators to comply with this AD. There are approximately 201 U.S.-registered airplanes. The average labor rate is $80 per hour. Estimated Costs Action Work hours Parts Cost per airplane Fleet cost Detailed inspection for cracks of the main fitting (required by AD 2004-20-09) 1 N/A $80, per inspection cycle $16,080 per inspection cycle. Detailed inspection for sealant damage of the bushing (required by AD 2004-20-09) 1 N/A $80, per inspection cycle $16,080 per inspection cycle. Ultrasonic inspection for cracks of the main fittings (required by AD 2004-20-09) 1 N/A $80, per inspection cycle $16,080, per inspection cycle. Replacement (new action) 56 $105,732 $110,212 $22,152,612. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. 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. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect 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. For the reasons discussed above, I certify that this AD:
(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)Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration
(FAA)amends § 39.13 by removing amendment 39-13814 (69 FR 59790, October 6, 2004) and by adding the following new airworthiness directive (AD): **2007-01-07 BOMBARDIER, INC. (Formerly Canadair):** Amendment 39-14879. Docket No. FAA-2005-22559; Directorate Identifier 2005-NM-076-AD. Effective Date
(a)This AD becomes effective February 16, 2007. Affected ADs
(b)This AD supersedes AD 2004-20-09. Applicability
(c)This AD applies to Bombardier Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes, certificated in any category; serial numbers 7003 through 7067 inclusive, and 7069 through 8999 inclusive; equipped with main landing gear
(MLG)main fittings, having part number (P/N) 601R85001-3 or -4 (Messier-Dowty P/N 17064-101, -102, -103, or -104). Unsafe Condition
(d)This AD results from a report of a cracked main fitting of the MLG. We are issuing this AD to detect and correct fatigue cracking of the main fitting of the MLG and consequent failure of the main fitting, which could result in the collapse of the MLG. Compliance
(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Service Bulletin
(f)Unless otherwise specified in this AD, the term “service bulletin,” as used in this AD, means the Accomplishment Instructions of the applicable service bulletin identified in paragraph (f)(1) or (f)(2) of this AD.
(1)For the actions specified in paragraphs (g), (h), (i), (j), and
(k)of this AD: Bombardier Alert Service Bulletin A601R-32-099, including Appendices A, B, and D, and excluding Appendix C, dated September 15, 2004; or Bombardier Alert Service Bulletin A601R-32-099, Revision A, including Appendices A, B, and D, and excluding Appendix C, dated December 13, 2004; or Bombardier Alert Service Bulletin A601R-32-099, Revision B, dated June 16, 2005, including Appendices A, B, and D, and excluding Appendix C, Revision A, dated December 13, 2004.
(2)For the actions specified in paragraph
(l)of this AD: Bombardier Service Bulletin 601R-32-093, Revision B, dated July 14, 2005.
(3)After the effective date of this AD, only Revision B of Bombardier Alert Service Bulletin A601R-32-099, dated July 16, 2005, may be used for the actions specified in paragraphs (g), (h), (i), (j), and
(k)of this AD.
(4)Although the service bulletins identified in paragraph (f)(1) of this AD specify to submit certain information to the airplane manufacturer and to return cracked main fittings to the supplier, this AD does not include those requirements. Restatement of the Requirements of AD 2004-20-09 Initial Inspections at New Reduced Compliance Times
(g)Do the actions in Table 1 of this AD. Table 1.—Initial Inspection Thresholds at New Reduced Compliance Times Do the following in Column 1— Column 1— At the earlier of the times specified in Column 2 or Column 3— Column 2—The latest of— Column 3—The latest of—
(1)A detailed inspection for cracks of the inboard and outboard sides of the main fitting of the MLG between the pintle pin trunnion and the radius of the shock strut lug, in accordance with Part A of the applicable service bulletin (i)(A) Before the accumulation of 8,000 total flight cycles since the main fitting of the MLG was new.
(B)Within 8,000 flight cycles since the last overhaul of the MLG done before the effective date of this AD.
(C)Within 50 flight cycles after October 21, 2004 (the effective date of AD 2004-20-09). (ii)(A) Within 48 months since the main fitting of the MLG was new.
(B)Within 48 months since the last overhaul of the MLG done before the effective date of this AD.
(C)Within 50 flight cycles after the effective date of this AD.
(2)A detailed inspection for sealant damage or corrosion around the forward bushing of the left and right main fittings of the MLG, in accordance with Part B of the applicable service bulletin (i)(A) Before the accumulation of 8,000 total flight cycles since the main fitting of the MLG was new.
(B)Within 8,000 flight cycles since the last overhaul of the MLG done before the effective date of this AD.
(C)Within 500 flight cycles after October 21, 2004. (ii)(A) Within 48 months since the main fitting of the MLG was new.
(B)Within 48 months since the last overhaul of the MLG done before the effective date of this AD.
(C)Within 500 flight cycles or 6 months after the effective date of this AD, whichever occurs first.
(3)An ultrasonic inspection for cracks of the left and right main fittings of the MLG, in accordance with Part C of the applicable service bulletin (i)(A) Before the accumulation of 8,000 total flight cycles since the main fitting of the MLG was new.
(B)Within 8,000 flight cycles, since the last overhaul of the MLG done before the effective date of this AD.
(C)Within 500 flight cycles after October 21, 2004. (ii)(A) Within 48 months since the main fitting of the MLG was new.
(B)Within 48 months since the last overhaul of the MLG done before the effective date of this AD.
(C)Within 500 flight cycles or 6 months after the effective date of this AD, whichever occurs first. Note 1: For the purposes of this AD, a detailed inspection is: “An intensive examination of a specific item, installation, or assembly to detect damage, failure, or irregularity. Available lighting is normally supplemented with a direct source of good lighting at an intensity deemed appropriate. Inspection aids such as mirror, magnifying lenses, etc., may be necessary. Surface cleaning and elaborate procedures may be required.” Repetitive Inspections
(h)Repeat the inspections in paragraph
(g)of this AD thereafter at the applicable interval in paragraph (h)(1) or (h)(2) of this AD, until the terminating action required by paragraph
(l)of this AD is accomplished.
(1)For airplanes on which the applicable initial inspection in paragraph
(g)of this AD has been done before the effective date of this AD, do the next inspection at the applicable interval in Table 2 of this AD.
(2)For airplanes on which the applicable initial inspection in paragraph
(g)of this AD has not been done before the effective date of this AD, repeat the inspection at the applicable interval in Table 2 of this AD. Table 2.—Repetitive Inspections at New Intervals For the inspection required by— Repeat at intervals not to exceed— Until the action required by—
(3)Paragraph (g)(1) of this AD 5 days Paragraph (g)(3) of this AD is done, unless required by paragraph
(j)of this AD.
(4)Paragraph (g)(2) of this AD 500 flight cycles or 6 months, whichever occurs first Paragraph (j)(2) of this AD is done.
(5)Paragraph (g)(3) of this AD 5,000 flight cycles or 30 months, whichever occurs first, except as required by paragraph (j)(2) of this AD (None). Corrective Actions
(i)If there is an indication of a crack during any inspection required by paragraph (g)(1), (h)(3), or (j)(1) of this AD, before further flight, do the actions specified in paragraph (i)(1) or (i)(2) of this AD in accordance with part A of the applicable service bulletin; or do the terminating action required by paragraph
(l)of this AD before further flight.
(1)Replace the cracked main fitting of the MLG with a new or serviceable main fitting.
(2)Do an eddy current inspection to verify whether there is a crack. If there is a crack, replace the cracked main fitting of the MLG with a new or serviceable main fitting.
(j)If any sealant damage or corrosion is found during any inspection required by either paragraph (g)(2) or (h)(4) of this AD, do the actions specified in Table 3 of this AD in accordance with part B of the applicable service bulletin, until the terminating action required by paragraph
(l)of this AD is accomplished. Table 3.—Corrective Actions for Sealant Damage or Corrosion Do the inspection specified in— Within— Repeat at intervals not to exceed— Until the action specified in—
(1)Paragraph (g)(1) of this AD 5 days after doing the inspection required by (g)(2) or (h)(4) of this AD, as applicable 5 days Paragraph (j)(2) or
(l)of this AD is done.
(2)Paragraph (g)(3) of this AD 500 flight cycles after doing the inspection required by paragraph (g)(2) or (h)(4) of this AD, as applicable 500 flight cycles Paragraph
(l)of this AD is done.
(k)If there is an indication of a crack during any inspection required by paragraph (g)(3) or (h)(5) of this AD, before further flight, replace the cracked main fitting of the MLG with a new or serviceable main fitting in accordance with part C of the applicable service bulletin; or do the terminating action required by paragraph
(l)of this AD before further flight. New Requirement of This Ad Terminating Action—Replacement
(l)Within 15 months after the effective date of this AD, replace both main fittings of the MLG with new main fittings having new part numbers, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 601R-32-093, Revision B, dated July 14, 2005. Doing this replacement terminates all requirements of paragraphs (g), (h), (i), (j), and
(k)of this AD. Note 2: Bombardier Service Bulletin 601R-32-093, Revision B, refers to Messier-Dowty Service Bulletin M-DT SB17002-32-24, dated October 9, 2003; and Messier-Dowty Service Bulletin M-DT SB17002-32-25, Revision 1, dated October 17, 2003; as additional sources of service information for replacing the MLG main fitting. Actions Accomplished in Accordance With Earlier Issues of Service Bulletin
(m)Actions done before the effective date of this AD in accordance with the service bulletins listed in Table 4 of this AD are acceptable for compliance with the corresponding action specified in this AD. Table 4.—Earlier Issues of Service Bulletins Service Bulletin Revision level Date Bombardier Service Bulletin 601R-32-093 Original October 17, 2003. Bombardier Service Bulletin 601R-32-093 A September 21, 2004. Parts Installation
(n)As of the effective date of this AD, no person may install a main fitting of the MLG, Bombardier P/N 601R85001-3 or 601R85001-4; also referred to as Messier-Dowty P/N 17064-101, 17064-102, 17064-103, or 17064-104; on any airplane. Alternative Methods of Compliance (AMOCs) (o)(1) The Manager, New York Aircraft Certification Office, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(2)Before using any AMOC approved in accordance with § 39.19 on any airplane to which the AMOC applies, notify the appropriate principal inspector in the FAA Flight Standards Certificate Holding District Office. Related Information
(p)Canadian airworthiness directive CF-2004-18R1, dated September 21, 2005, also addresses the subject of this AD. Material Incorporated by Reference
(q)You must use the applicable service bulletin identified in Table 5 of this AD to perform the actions that are required by this AD, unless the AD specifies otherwise. Table 5.—All Material Incorporated by Reference Service Bulletin Revision level Date Bombardier Alert Service Bulletin A601R-32-099, including Appendices A, B, and D, and excluding Appendix C Original September 15, 2004. Bombardier Alert Service Bulletin A601R-32-099, including Appendices A, B, and D, and excluding Appendix C A December 13, 2004. Bombardier Alert Service Bulletin A601R-32-099, including Appendices A, B, and D, and excluding Appendix C, Revision A, dated December 13, 2004 B June 16, 2005. Bombardier Service Bulletin 601R-32-093 B July 14, 2005.
(1)The Director of the Federal Register approved the incorporation by reference of the documents identified in Table 6 of this AD in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Table 6.—New Material Incorporated by Reference Service Bulletin Revision level Date Bombardier Alert Service Bulletin A601R-32-099, including Appendices A, B, and D, and excluding Appendix C A December 13, 2004. Bombardier Alert Service Bulletin A601R-32-099, including Appendices A, B, and D, and excluding Appendix C, Revision A, dated December 13, 2004 B June 16, 2005. Bombardier Service Bulletin 601R-32-093 B July 14, 2005.
(2)On October 21, 2004 (69 FR 59790, October 6, 2004), the Director of the Federal Register approved the incorporation by reference of Bombardier Alert Service Bulletin A601R-32-099, including Appendices A, B, and D, and excluding Appendix C, dated September 15, 2004.
(3)Contact Bombardier, Inc., Canadair, Aerospace Group, P.O. Box 6087, Station Centre-ville, Montreal, Quebec H3C 3G9, Canada, for a copy of this service information. You may review copies at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street SW., Room PL-401, Nassif Building, Washington, DC; on the Internet at *http://dms.dot.gov* ; or at the National Archives and Records Administration (NARA). For information on the availability of this material at the NARA, call
(202)741-6030, or go to *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.* Issued in Renton, Washington, on December 21, 2006. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-223 Filed 1-11-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2006-25673; Airspace Docket No. 06-ASW-13] RIN 2120-AA66 Modification of VOR Federal Airway V-2; East Central United States AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This action modifies VOR Federal Airway V-2 over the East Central United States to support modified arrival and departure procedures to the Detroit Metropolitan Wayne County Airport (DTW), Detroit, Michigan. These procedures were modified in conjunction with the Midwest AirSpace Enhancement
(MASE)project. The FAA is taking this action to enhance safety and to improve the efficient use of the navigable airspace assigned to the Chicago and Cleveland Air Route Traffic Control Centers (ARTCC). DATES: *Effective Date:* 0901 UTC, March 15, 2007. 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: Steve Rohring, Airspace and Rules, Office of System Operations Airspace and Aeronautical Information Management, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591; telephone:
(202)267-8783. SUPPLEMENTARY INFORMATION: History On September 6, 2006, the FAA published in the **Federal Register** a notice of proposed rulemaking to realign V-2 over the East Central United States (71 FR 52502). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. No comments were received in response to the proposal. VOR Federal Airways are published in paragraph 6010 of FAA Order 7400.9P dated September 1, 2006, and effective September 15, 2006, which is incorporated by reference in 14 CFR 71.1. The VOR Federal Airway listed in this document will be published subsequently in the Order. The Rule This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 to modify VOR Federal Airway V-2 over the East Central United States. This action supports arrival and departure procedures to DTW that were modified in conjunction with MASE. Further, this action enhances safety and improves the efficient use of the navigable airspace within the areas of responsibility for Chicago and Cleveland ARTCCs. 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 Department of Transportation
(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. Environmental Review The FAA has determined that this action qualifies for categorical exclusion under the National Environment Policy Act in accordance with 311a., FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures”. This airspace action is not expected to cause any potentially significant environment impacts, and no extraordingary circumstances exist that warrant preparation of environmental assessment. 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 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 FAA Order 7400.9P, Airspace Designations and Reporting Points, dated September 1, 2006, and effective September 15, 2006, is amended as follows: Paragraph 6010 VOR Federal airways. V-2 [Revised] From Seattle, WA; Ellensburg, WA; Moses Lake, WA; Spokane, WA; Mullan Pass, ID; Missoula, MT; Helena, MT; INT Helena 119° and Livingston, MT, 322° radials; Livingston; Billings, MT; Miles City, MT; 24 miles, 90 miles, 55 MSL, Dickinson, ND; 10 miles, 60 miles, 38 MSL, Bismarck, ND; 14 miles, 62 miles, 34 MSL, Jamestown, ND; Fargo, ND; Alexandria, MN; Gopher, MN; Nodine, MN; Lone Rock, WI; Madison, WI; Badger, WI; Muskegon, MI; Lansing, MI; Salem, MI; INT Salem 082° and Aylmer, ON, Canada, 261° radials; Aylmer; INT Aylmer 086° and Buffalo, NY, 259° radials; Buffalo; Rochester, NY; Syracuse, NY; Utica, NY; Albany, NY; INT Albany 084° and Gardner, MA, 284° radials; to Gardner. The airspace within Canada is excluded. Issued in Washington, DC, on January 5, 2007. Edith V. Parish, Manager, Airspace and Rules. [FR Doc. E7-322 Filed 1-11-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 73 [Docket No. FAA-2006-26599; Airspace Docket No. 06-ASW-11] RIN 2120-AA66 Change to Controlling Agency of Restricted Area 2312; Fort Hauchuca, AZ AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This action amends the controlling agency for Restricted Area 2312 (R-2312), Fort Hauchuca, AZ. Specifically, this action amends the controlling agency from “Libby [Army Air Field] AAF [Airport Traffic Control Tower] ATCT” to “Albuquerque [Air Route Traffic Control Center] ARTCC.” This is an administrative change that does not alter the boundaries, designated altitudes, time of designation, or activities conducted within R-2312. The FAA is taking this action at the request of the United States (U.S.) Army and the U.S. Air Force because Libby AAF ATCT is not a 24-hour facility and R-2312 is not fully contained within the airspace delegated to Libby AAF ATCT by Albuquerque ARTCC. DATES: *Effective Date:* 0901 UTC, March 15, 2007. FOR FURTHER INFORMATION CONTACT: Steve Rohring, Airspace and Rules, Office of System Operations Airspace and AIM, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591; telephone:
(202)267-8783. SUPPLEMENTARY INFORMATION: Background On March 13 and March 17, 2006, respectively, the U.S. Army and the U.S. Air Force requested that the FAA take action to amend the controlling agency for R-2312, Fort Hauchuca, AZ from “Libby AAF ATCT” to “Albuquerque ARTCC.” The reason for the change is because Libby AAF ATCT is not a 24-hour facility and R-2312 is not fully contained within the airspace delegated to Libby AAF ATCT by Albuquerque ARTCC. The Rule At the request of the U.S. Army and the U.S Air Force, the FAA is amending the controlling agency for R-2312, Fort Hauchuca, AZ from “Libby AAF ATCT” to “Albuquerque ARTCC”. This is an administrative change that does not alter the boundaries, designated altitudes, time of designation, or activities conducted within R-2312. Therefore, notice and public procedures under 5 U.S.C. 553(b) are unnecessary. 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 Department of Transportation
(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. Environmental Review The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with 311d., FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures.” This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment. List of Subjects in 14 CFR Part 73 Airspace, Prohibited areas, Restricted areas. Adoption of the Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 73 as follows: PART 73—SPECIAL USE AIRSPACE 1. The authority citation for part 73 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. § 73.23 [Amended] 2. § 73.23 is amended as follows: R-2312 Fort Huachuca, AZ [Amended] Under Controlling Agency, by removing the words “Libby AAF ATCT” and inserting the words “Albuquerque ARTCC.” Issued in Washington, DC, on January 4, 2007. Edith V. Parish, Manager, Airspace and Rules. [FR Doc. E7-323 Filed 1-11-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 73 [Docket No. FAA-2006-26646; Airspace Docket No. 06-ASW-12] RIN 2120-AA66 Change to Time of Designation of Restricted Area 6320; Matagorda, TX AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This action amends the time of designation for Restricted Area 6320 (R-6320), Matagorda, TX. Specifically, this action amends the time of designation from “Continuous” to “Intermittent by [Notice to Airmen] NOTAM.” This rule makes no other changes to R-6320. The FAA is issuing this amendment because R-6320 is no longer continuously needed for the aerostat balloon, used in support of U.S. National Security interests. EFFECTIVE DATE: 0901 UTC, March 15, 2007. FOR FURTHER INFORMATION CONTACT: Steve Rohring, Airspace and Rules, Office of System Operations Airspace and AIM, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591; telephone:
(202)267-8783. SUPPLEMENTARY INFORMATION: Background In response to public concern, the FAA approached the United States (U.S.) Custom Service and the U.S. Air Force Air Combat Command with a request to reduce the time of designation for R-6320. On June 15, 2006, the U. S. Customs Service and the U.S. Air Force concurred with reducing the time of designation from “Continuous” to “Intermittent by NOTAM.” The reason for the change is because R-6320 is no longer continuously needed for the aerostat balloon. The Rule The FAA is amending the time of designation for R-6320 from “Continuous” to “Intermittent by NOTAM.” This rule makes no other changes to R-6320. This action reduces the burden on the public by reducing the time of designation. Therefore, notice and public procedures under 5 U.S.C. 553(b) are unnecessary. Section 73.63 of Title 14 CFR part 73 was republished in FAA Order 7400.8M, dated January 6, 2006. 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 Department of Transportation
(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. Environmental Review The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with 311c., FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures”. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment. List of Subjects in 14 CFR Part 73 Airspace, Prohibited areas, Restricted areas. Adoption of the Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 73 as follows: PART 73—SPECIAL USE AIRSPACE 1. The authority citation for part 73 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. § 73.63 [Amended] 2. § 73.63 is amended as follows: R-6320 Matagorda, TX [Amended] Under Time of designation, by removing the word “Continuous” and inserting the words “Intermittent by NOTAM.” Issued in Washington, DC on January 5, 2007. Edith V. Parish, Manager, Airspace and Rules. [FR Doc. E7-392 Filed 1-11-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 121 [Docket No. FAA-2006-24277; Amendment No. 121-330] RIN 2120-AI75 Fire Penetration Resistance of Thermal/Acoustic Insulation Installed on Transport Category Airplanes AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: The FAA extends, by 24 months, the date for operators to comply with the fire penetration resistance requirements of thermal/acoustic insulation used in transport category airplanes manufactured after September 2, 2007. This extension is from September 2, 2007, to September 2, 2009. This action is necessary to allow airframe manufacturers enough time, after getting an acceptable certification test facility, to select and certificate appropriate installations. DATES: This amendment becomes effective February 12, 2007. FOR FURTHER INFORMATION CONTACT: Jeff Gardlin, FAA, Airframe and Cabin Safety Branch, ANM-115, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)227-2136, facsimile
(425)227-1149, e-mail: *jeff.gardlin@faa.gov.* SUPPLEMENTARY INFORMATION: Availability of Rulemaking Documents You can get an electronic copy using the Internet by:
(1)Searching the Department of Transportation's electronic Docket Management System
(DMS)Web page ( *http://dms.dot.gov/search* );
(2)Visiting the FAA's Regulations and Policies Web page at *http://www.faa.gov/regulations_policies/;* or
(3)Accessing the Government Printing Office's Web page at *http://www.gpoaccess.gov/fr/index.html.* You can also get a copy by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW., Washington, DC 20591, or by calling
(202)267-9680. Make sure to identify the amendment number or docket number of this rulemaking. Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act statement in the **Federal Register** published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit *http://dms.dot.gov.* Small Business Regulatory Enforcement Fairness Act The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. If you are a small entity and you have a question regarding this document, you may contact its local FAA official, or the person listed under FOR FURTHER INFORMATION CONTACT . You can find out more about SBREFA on the Internet at *http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.* Authority for This Rulemaking 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 III, Section 44701. Under that section, the FAA is charged with promoting safe flight of civil aircraft in air commerce by prescribing minimum standards required in the interest of safety for the design and performance of aircraft. This regulation is within the scope of that authority, because it prescribes new safety standards for the design of transport category airplanes. Background We issued a notice of proposed rulemaking
(NPRM)on April 3, 2006 (71 FR 16678) to extend the compliance date of 49 CFR 121.312(e)(3) because of unforeseen difficulties in establishing acceptable test equipment for showing compliance with that regulation. As discussed in the NPRM, that section requires that transport category airplanes manufactured after September 2, 2007, comply with the provisions of 14 CFR 25.856(b) when entering part 121 service. Section 25.856(b), in turn, requires that thermal/acoustic insulation installed in the lower half of the fuselage of those airplanes resist penetration of an external fire. The performance criteria are contained in Appendix F, part VII of part 25. Based on difficulties in obtaining and qualifying the necessary test equipment that arose following publication of the requirement, we determined that the compliance date for § 121.312(e)(3) should be extended. This is discussed in detail in the NPRM. Discussion of Comments Nine commenters responded to the NPRM. Two commenters, Daher-Lhotellier and Cogebi, are affiliated insulation material manufacturers that do not support extending the compliance date. These commenters contended that materials meeting the rule are available and that compliance within the existing date is possible. They provided no further information. The basis of the proposed extension was that manufacturers were not able to show that materials that are optimized for cost and weight would reliably meet the requirement. We agree there are materials that satisfy the test requirements of the regulation, but these are heavier or more expensive than envisioned by the rule. The commenters did not address this point in their comments. We therefore do not agree the current compliance date should be maintained. All other commenters (Airbus, Airline Pilots Association (ALPA), Air Transport Association (ATA), Association of European Airlines (AEA), Aerospace Industries Association (AIA), Boeing, and Bombardier) supported an extension to the compliance date. ALPA agreed that an extension of the compliance date is warranted, but had other comments on the basic requirement. These comments included expanding the number of airplanes affected, and the portion of the airplane that must be protected with insulation meeting the requirement. ALPA had made these same comments during the original rulemaking. These comments went beyond the scope of the NPRM, which simply addresses the compliance date for newly manufactured airplanes. However, as discussed in the original rulemaking, we have determined that broadening the applicability of the rule would have a very small benefit, and significant cost. Airbus, Boeing, Bombardier, AIA and AEA all contended the test equipment is still not sufficiently developed to support a fixed compliance date. They maintained the scatter in test results is too wide for a certification standard. We do not agree. The FAA William J. Hughes Technical Center has worked aggressively to resolve the issues with the test equipment, and has made significant progress in eliminating differences between test facilities. The most significant issue was the difference in performance between two test burners with slightly different configurations. We have developed small modifications that bring the two configurations into alignment. These modifications have been distributed to the test facilities that required them. In addition, we have conducted a series of tests with different materials to confirm the modifications do, in fact, work. It should be noted that all test methods, and in particular, fire test methods, have variability. This test method is consistent with other fire test methods in terms of the variation in results from one test to the next. As discussed below, some of the variation in test results is not because of the test method or equipment. We have also identified variability in materials that can lead to variability in test results. In the tests cited by these commenters, many of the materials tested were “off the shelf” and not necessarily developed to comply with an aviation safety standard. More recent efforts to develop materials whose properties were carefully controlled have shown the test results can be very consistent, if the material being tested is itself very consistent. Airbus, Boeing, and AIA commented the burner used in the test method is obsolete, and no longer available. They stated this contributes to difficulties in obtaining consistency among facilities and within a facility. While the burner is no longer commercially available; there are numerous burners already in industry. As discussed above, the FAA Technical Center has developed refinements to the burner that standardize its performance. However, as the supply of burners is limited, we have also developed an alternative burner that eliminates many of the parameters that are currently the source of performance variations. This design will be documented and the plans made available to anyone requesting them. The new burner can be fabricated from standard parts and should eliminate concerns that the old burner is out of production. Airbus commented there are no commercially available test facilities. At the time the comment was made, no commercial facilities had requested FAA acceptance. However, since the NPRM was published, two facilities have requested and received FAA review and would be eligible to conduct certification testing if they so choose. Airbus also commented the late availability of the associated advisory circular
(AC)25.856-2 has contributed to the need for further extension. Airbus noted the final AC was published in January 2006, and not concurrently with the final rule. They stated the lack of published guidance affected their ability to begin designing suitable solutions. Part of the reason the AC publication was delayed was to permit as much consideration as possible of the equipment issues that had arisen. We had to balance the need to issue the AC as soon as possible with the need to make it as comprehensive as possible. The absence of the AC did not, however, limit any manufacturer's ability to propose, and gain acceptance for, methods of compliance. The FAA has worked with each affected manufacturer to develop methods of compliance. While the ideal situation would have been to have the AC available concurrent with the final rule, this should not have inhibited the development of methods of compliance. Bombardier, Boeing and Airbus, with supporting comments from AEA and AIA, contended there are no, or limited, materials available that satisfy the cost/weight criteria specified in the original rulemaking. We believe that part of this comment stemmed from the prior problems with test equipment, and the potential for certain materials to pass at one facility, but fail at another. Since the material used to establish cost and weight in the original rulemaking is still available, we do not agree there are no materials available. However, we agree the scatter in test results that prompted this rule introduced uncertainty, and reluctance on the part of the manufacturers to commit to a material. Bombardier commented on specific areas of the airplane that may be more complex to address than others, as well as some alternative approaches to providing protection from flame penetration. These comments were not directly related to the subject of the compliance date. Nonetheless, we agree that some areas of the airplane are more complicated than others, but this was accounted for in the rulemaking. In terms of alternative approaches, an applicant is free to propose an approach that provides an equivalent level of safety. Boeing expressed a concern that the local Aircraft Certification Offices will not have enough information with which to review, and find acceptable, test facilities. As noted above, two facilities have been reviewed and accepted to date. The FAA plans to make such reviews a priority and there have been no unforeseen difficulties in successfully accomplishing the facility review. Boeing and Airbus both indicated that they cannot comply, even with a 12 month extension. They stated their current production schedules and design requirements mean that compliance with the existing proposal will cause severe disruption of their schedules and cause them to implement materials that are heavier, or more costly than can be developed soon. This in turn would require them to change configurations twice: once to meet the compliance date, and again to optimize the materials, after they complete their development. They proposed an additional 12 month extension, for a total of 24 months to minimize disruption of their production. We have carefully considered these comments, as they are fundamental to the impact of the rule. When the original rule was promulgated, we determined that a four year compliance time was sufficient for newly manufactured airplanes. This assessment presumed that materials and test equipment were readily available and that manufacturers would begin to address compliance immediately. However, we have acknowledged the test equipment was not readily available in a condition to always provide reliable test results, and that this brought into question the suitability of certain materials presumed to be acceptable. Since this rule does add weight and cost to the airplane, the balance between the total cost impact and the safety benefit is very important. If the cost of implementating the rule is much more significant than anticipated, the justification for the rule may be revisited. Since we believe the rule provides a significant safety benefit, we must maintain the balance between the cost impact, and the safety benefit provided. Clearly, for various reasons, two major airplane manufacturers are not prepared to comply with the rule, even allowing for a 12 month extension from the original compliance date. While we do not agree that all the reasons for this lie with the issues associated with the test method, we believe that the current proposal will result in significantly greater economic impact than was anticipated. We have worked closely with each of the affected airplane manufacturers to address compliance questions and certification methodology. This has involved on-site visits and inspection of airplane design details, in addition to numerous discussions. These reviews give us a good appreciation of the magnitude of the design changes required to achieve compliance, which are substantial. Since a significant amount of the compliance time was absorbed with test equipment issues, the airplane manufacturers are significantly behind in implementing designs. Even though we had concluded that a 12 month extension would be sufficient, the two largest airplane manufactures are clearly not postured to accommodate compliance in that timeframe using materials that they consider optimal and that they intend to use for future compliance. We agree that they could not comply within the current proposed timeframe without a substantial cost impact that we did not originally anticipate. Considering all of the above we have concluded that an additional 12 month extension, for a total of 24 months, is appropriate to implement this requirement in keeping with the original cost/benefit balance of the rule. In making this decision, we have considered that we would very likely receive petitions for exemption to address specific certification programs if the current proposal is maintained. The potential for further extensions is a significant factor in changing the proposal. Barring some unforeseen event, we do not envision any more changes to the compliance date. The final rule is changed accordingly. Notwithstanding the 24 month extension, we would expect the manufacturers to implement the required design changes as early as possible, to improve the safety of the fleet. Paperwork Reduction Act There are no current or new requirements for information collection associated with this amendment. International Compatibility In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to comply with International Civil Aviation Organization
(ICAO)Standards and Recommended Practices to the maximum extent practicable. The FAA has determined that there are no ICAO Standards and Recommended Practices that correspond to these regulations. Regulatory Evaluation, Regulatory Flexibility Analysis, International Trade Impact Assessment, and Unfunded Mandate Assessment Changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 directs that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, the Trade Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995). This portion of the preamble summarizes the FAA's analysis of the economic impacts of this final rule. Department of Transportation Order DOT 2100.5 prescribes policies and procedures for simplification, analysis, and review of regulations. If the expected cost impact is so minimal that a proposed or final rule does not warrant a full evaluation, this order permits that a statement to that effect and the basis for it be included in the preamble if a full regulatory evaluation of the cost and benefits is not prepared. Such a determination has been made for this final rule. The reasoning for this determination follows: A two-year postponement of the new thermal acoustic insulation standards would spare manufactures an added setup cost of slightly less than $60 million at an expected societal loss of $4 million in benefits. The Improved Flammability Standards for Thermal/Acoustic Insulation final regulatory evaluation (July, 2002) estimated the new insulation requirements would produce present value benefits of $222.6 million with present value costs of $108.4 million (Table M). The two-year benefit/cost delay dichotomy is because of large set up costs and a relatively short postponement of corresponding benefits. The benefits increase slowly with a gradual increase in the fleet because of annual deliveries of new production airplanes with the new thermal/acoustic insulation. As shown in the 2002 final regulatory evaluation nearly half of the regulatory evaluation estimated $108 million present value costs are the setup costs ($58.1 million in present value), which are incurred in the two years before installing the improved insulation on new production airplanes. These setup costs occur because of configuration management, or the cost resulting from engineering time to change airplane configuration—such as fully accounting for all parts, tools, and shop manual changes. To be in compliance with the new requirements the industry would first have to install a heavier insulation, before lighter weight insulation becomes fully available. Two different types of insulation materials require configuration management costs to double. Thus this final rule results in large cost savings with a minor loss in social benefits. The FAA has, therefore, determined that this final rule is not a “significant regulatory action” as defined in section 3(f) of Executive Order 12866, and is not “significant” as defined in DOT's Regulatory Policies and Procedures. Regulatory Flexibility Analysis The Regulatory Flexibility Act of 1980 (Pub. L. 96-354)
(RFA)establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation. To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration.” The RFA covers a wide-range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions. Agencies must perform a review to determine whether a rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the RFA. However, if an agency determines that a rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) of the RFA provides that the head of the agency may so certify and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear. With this rule airplane manufacturers will avoid incurring an added configuration management cost. While these manufacturers are not small entities, the small entity operators are expected to save fuel burn expense, as the one-year interim fix insulation is heavier. Thus this rule is cost relieving and does not impose a significant economic impact on a substantial number of small entities. We did not receive comments following the NPRM about the cost impact on small entities. Therefore, as the FAA Administrator, I certify that this rule will not have a significant economic impact on a substantial number of small entities. International Trade Impact Assessment The Trade Agreements Act of 1979 (Pub. L. 96-39) prohibits Federal agencies from establishing any standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Legitimate domestic objectives, such as safety, are not considered unnecessary obstacles. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. The FAA has assessed the potential effect of this final rule and has determined that it provides the same cost relief to domestic and international entities and thus has a neutral trade impact. Unfunded Mandate Assessment Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (adjusted annually for inflation with the base year 1995) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $128.1 million in lieu of $100 million. This final rule does not contain such a mandate. Executive Order 13132, Federalism The FAA has analyzed this final rule under the principles and criteria of Executive Order 13132, Federalism. We determined that this action will not have a substantial direct effect on the States, or the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government, and therefore does not have federalism implications. Regulations Affecting Intrastate Aviation in Alaska Section 1205 of the FAA Reauthorization Act of 1996 (110 Stat. 3213) requires the FAA, when modifying its regulations in a manner affecting intrastate aviation in Alaska, to consider the extent to which Alaska is not served by transportation modes other than aviation, and to establish appropriate regulatory distinctions. In the NPRM, we requested comments on whether the proposed rule should apply differently to intrastate operations in Alaska. We didn't receive any comments, and we have determined, based on the administrative record of this rulemaking, that there is no need to make any regulatory distinctions applicable to intrastate aviation in Alaska. Environmental Analysis FAA Order 1050.1E identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act in the absence of extraordinary circumstances. The FAA has determined this rulemaking action qualifies for the categorical exclusion identified in paragraph 3f and involves no extraordinary circumstances. Regulations That Significantly Affect Energy Supply, Distribution, or Use The FAA has analyzed this final rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 18, 2001). We have determined that it is not a “significant energy action” under the executive order because it is not a “significant regulatory action” under Executive Order 12866, and it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. List of Subjects in 14 CFR Part 121 Aircraft, Aviation safety, Reporting and recordkeeping requirements, Safety, Transportation. The Amendment In consideration of the foregoing, the Federal Aviation Administration amends Chapter I of Title 14, Code of Federal Regulations as follows: PART 121—OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS 1. The authority citation for part 121 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 40119, 44101, 44701-44702, 44705, 44709-44711, 44713, 44716-44717, 44722, 44901, 44903-44904, 44912, 46105. 2. Amend § 121.312 by revising paragraph (e)(3) to read as follows: § 121.312 Materials for compartment interiors.
(e)* * *
(3)For airplanes with a passenger capacity of 20 or greater, manufactured after September 2, 2009, thermal/acoustic insulation materials installed in the lower half of the fuselage must meet the flame penetration resistance requirements of § 25.856 of this chapter, effective September 2, 2003. Issued in Washington, DC, on January 4, 2007. Marion C. Blakey, Administrator. [FR Doc. E7-338 Filed 1-11-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Parts 125 and 135 [Docket No. FAA-2004-18596; Amendment No. SFAR 106] RIN 2120-AI30 Use of Certain Portable Oxygen Concentrator Devices Onboard Aircraft AGENCY: Federal Aviation Administration, DOT. ACTION: Final rule; technical amendment. SUMMARY: The Federal Aviation Administration
(FAA)is making minor technical changes to a final rule published in the **Federal Register** on July 12, 2005 (70 FR 40156). That final rule created Special Federal Aviation Regulation 106 (SFAR 106). In that final rule the FAA inadvertently failed to make conforming amendments to additionally apply the SFAR to parts 125 and 135 as proposed, and to include references in those parts to the existence of SFAR 106 published in part 121. EFFECTIVE DATES: Effective on February 12, 2007. FOR FURTHER INFORMATION CONTACT: David L. Catey, Air Transportation Division, AFS-200, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone
(202)267-3732. SUPPLEMENTARY INFORMATION: The Federal Aviation Administration
(FAA)published SFAR 106, “Use of Certain Portable Oxygen Concentrator Devices onboard Aircraft,” in the **Federal Register** on July 12, 2005 (70 FR 40156). We inadvertently failed to attach notes to parts 125 and 135 of Title 14 of the Code of Federal Regulations (14 CFR) that would direct operators subject to those regulations to the body of SFAR 106. When the FAA published the notice of proposed rulemaking
(NPRM)that offered the proposed SFAR to the public for comment, we clearly stated that the proposed regulation would apply to civil aircraft in parts 121, 125, and 135. The NPRM was published in the **Federal Register** on July 14, 2004 (69 FR 42324), and in the heading we noted that the proposal applied to 14 CFR Parts 121, 125, and 135. The applicability for an SFAR to a specific part of 14 CFR is not specifically cited in the Applicability section of the regulatory language, but rather cited in the heading of the SFAR and the parts affected contain an editorial note referring readers to the text of the SFAR. When the final rule was published, we failed to include those notes to parts 125 and 135. This technical amendment will add the editorial notes to parts 125 and 135 that direct the reader to the text of SFAR 106 and ensure that readers know the regulation applies to operations conducted under those parts. This amendment will not impose any additional restrictions on operators affected by these regulations. SFAR 106 permits passengers to carry on and use certain portable oxygen concentrator devices
(POCs)onboard aircraft if the aircraft operator ensures that the conditions specified in the SFAR for their use are met. Aircraft operators can now offer medical oxygen service as they did before SFAR 106 was enacted, or they can arrange for passengers to carry on and use one of the devices covered in SFAR 106. SFAR 106 is an enabling rule, which means that no aircraft operator is required to allow passengers to operate these devices onboard, but they may allow them to be operated onboard. If one of these devices is allowed by the aircraft operator to be carried on board, the conditions in the SFAR must be met. SFAR 106 allows for the use of five specific POC devices the FAA has found to be acceptable. Need for the Correction As stated above, this correction is needed to make clear that the conditions and regulations of SFAR 106 are also applicable to operations conducted under parts 125 and 135, as proposed in the NPRM and intended in the final rule. Technical Amendment The technical amendment will correct the omission of the editorial notes that direct operators under parts 125 and 135 to SFAR 106 in part 121. List of Subjects 14 CFR Part 125 Aircraft, Airmen, Aviation safety, Reporting and recordkeeping requirements 14 CFR Part 135 Air taxis, Aircraft, Aviation safety, Reporting and recordkeeping requirements. Accordingly, Title 14 of the Code of Federal Regulations
(CFR)parts 125 and 135 are amended as follows: PART 125—CERTIFICATION AND OPERATIONS: AIRPLANES HAVING A SEATING CAPACITY OF 20 OR MORE PASSENGERS OR A MAXIMUM PAYLOAD CAPACITY OF 6,000 POUNDS OR MORE; AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT. 1. The authority citation for part 125 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701-44702, 44705, 44710-44711, 44713, 44716-44717, 44722. 2. Special Federal Aviation Regulation No. 106 is added to part 125 to read as follows: SPECIAL FEDERAL AVIATION REGULATION NO. 106 *Editorial Note:* For the text of SFAR No. 106, see part 121 of this chapter. PART 135—OPERATING REQUIREMENTS: COMMUTER AND ON-DEMAND OPERATIONS AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT 3. The authority citation for part 135 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701-44702, 44705, 44709, 44711-44713, 44715-44717, 44722. 4. Special Federal Aviation Regulation No. 106 is added to part 135 to read as follows: SPECIAL FEDERAL AVIATION REGULATION NO. 106 *Editorial Note:* For the text of SFAR No. 106, see part 121 of this chapter. Issued in Washington, DC, on January 4, 2007. Rebecca B. MacPherson, Assistant Chief Counsel for Regulations. [FR Doc. E7-339 Filed 1-11-07; 8:45 am] BILLING CODE 4910-13-P CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1407 Portable Generators; Final Rule; Labeling Requirements AGENCY: Consumer Product Safety Commission. ACTION: Final rule. SUMMARY: The Consumer Product Safety Commission (Commission or CPSC) is issuing a final rule requiring manufacturers to label portable generators with performance and technical data related to performance and safety. The required warning label informs purchasers that: “Using a generator indoors CAN KILL YOU IN MINUTES;” “Generator exhaust contains carbon monoxide. This is a poison you cannot see or smell;” “NEVER use inside a home or garage, EVEN IF doors and windows are open;” “Only use OUTSIDE and far away from windows, doors, and vents.” The warning label also includes pictograms. The Commission believes that providing this safety information will help reduce unreasonable risks of injury associated with portable generators. 1 1 Acting Chairman Nancy A. Nord and Commissioner Thomas H. Moore each filed a statement. The statements are available from the Office of the Secretary or on the Commission's Web site at *http://www.cpsc.gov* . DATES: This regulation becomes effective May 14, 2007 and applies to any portable generator manufactured or imported on or after that date. FOR FURTHER INFORMATION CONTACT: Timothy P. Smith, Project Manager, Division of Human Factors, Directorate for Engineering Sciences, Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, Maryland; telephone
(301)504-7691; or e-mail: *tsmith@cpsc.gov* . SUPPLEMENTARY INFORMATION: A. Background The total yearly estimated non-fire related carbon monoxide
(CO)deaths for each of the years 1999 through 2002 are 109, 138, 130 and 188, respectively. Since 1999, the percentage of estimated CO poisoning deaths specifically associated with generators has been increasing annually. In 1999, generators were associated with 7 (6%) of the total yearly estimated CO poisoning deaths for that year. In 2000, 2001 and 2002, they were associated with 19 (14%), 22 (17%) and 46 (24%) deaths out of the total estimates for each of those years. On October 12, 2005, the staff was directed to undertake a thorough review of the status of portable generator safety. As part of this review, the staff was requested to assess the sufficiency of warning labels to address the CO poisoning hazard posed by portable generators that are used within or near residences. In response to this request, CPSC staff prepared a draft notice of proposed rulemaking (NPR), in which the staff proposed that manufacturers be required to label portable generators with a CO-poisoning warning label. On August 15, 2006, the Commission voted unanimously (2-0) to approve the publication of a **Federal Register** notice issuing an NPR for portable-generator labeling requirements. This notice was published August 24, 2006. 71 FR 50003. B. The Product Portable generators offer a means of providing electrical power to a location that either temporarily lacks it or is not provided with electrical service at all. A portable generator has an internal combustion engine to produce rotational energy, which is used to generate electricity. The engine may be fueled by gasoline, diesel, natural gas, or liquid propane. It is the engine that produces carbon monoxide as a byproduct of combustion. Estimates of sales of portable generators for consumer use vary, but could be more than a million units annually. The most popular of these generators are gasoline-powered and are priced in the $500 to $800 range. The output of the majority of light duty generators sold to consumers in 2005 was in the 3.5 kW to 6.5 kW range. This is the size of most of the units involved in the fatal CO poisoning incidents CPSC staff investigated in which the rating of the involved generator was identified. C. Relevant Statutory Provisions Section 27(e) of the Consumer Product Safety Act
(CPSA)authorizes the Commission, by rule, to “require any manufacturer of consumer products to provide the Commission with such performance and technical data related to performance and safety as may be required to carry out the purposes of this Act, and to give such notification of such performance and technical data at the time of original purchase to prospective purchasers and to the first purchaser of such product for purposes other than resale, as it determines necessary to carry out the purposes of this Act.” As provided in section 2(b)(1) of the Consumer Product Safety Act (15 U.S.C. 2051(b)(1)), one purpose of the CPSA is “to protect the public against unreasonable risks of injury associated with consumer products.” Failure to comply with a rule under section 27(e) is unlawful under section 19(a)(8) of the CPSA. 15 U.S.C. 2068(a)(8). Any person who knowingly violates this requirement is subject to a civil penalty of up to $8,000 per violation. 15 U.S.C. 2069; 64 FR 51963. D. Explanation of the Rule In 2002, CPSC staff assessed the effectiveness of current CO poisoning warnings found on the product and within the owner's manuals of several models of portable generators found on store shelves. Staff found that the guidance provided for avoiding the hazard was typically twofold:
(1)Do not use in a confined or enclosed space, and
(2)provide proper ventilation. None of the evaluated warnings defined “confined or enclosed space” or “proper ventilation.” The Commission believes these instructions and warnings do not adequately advise users how to avoid the CO poisoning hazard. Furthermore, the incident data includes fatalities where it appears that the victims attempted to provide adequate ventilation, to open confined areas, or to do both by, for example, opening doors, opening windows, and running exhaust fans. Prior research has shown that tools with gasoline-powered engines produce CO that “can rapidly accumulate, even in areas that appear to be well-ventilated, resulting in dangerous and fatal concentrations within minutes.” 2 Thus, evidence suggests that the methods consumers typically use to provide ventilation or to open confined areas are insufficient to prevent hazardous levels of CO buildup. Even locating a generator outdoors can be insufficient if the generator is near enough to openings to the home or other occupied structure to allow CO to permeate and subsequently accumulate indoors. CPSC is aware of at least 5 deaths that occurred when a generator was situated outdoors but near openings to the home. In addition, the Centers for Disease Control and Prevention recently reported the results of a study of post-hurricane related generator use in 2005 that found up to 50% of non-fatal CO poisoning incidents involved generators operated outdoors but within one to seven feet from the home. 3 2 Earnest, G.S., Carbon Monoxide Poisonings from Small, Gasoline-Powered, Internal Combustion Engines: Just What is a “Well-Ventilated Area”?, American Industrial Hygiene Association Journal, November 1997. 3 CDC, Carbon Monoxide Poisoning After Two Major Hurricanes—Alabama and Texas, August-October 2005, MMWR March 10, 2006; 55(09); 236-239. The Commission believes that there are too many unknown variables to be able to recommend one single safe distance for the location of a portable generator relative to a home or dwelling. Variables such as the wind speed and direction relative to openings to indoor spaces, relative proximity of other structures in the area that could create wind vortices, direction in which the engine exhaust is pointing, and a multitude of other factors complicate attempts to define a safe distance. Notwithstanding the issue of defining a safe operating distance, the Commission believes that warning labels must instruct consumers to keep generators outdoors and away from air intakes during use. In 2003, the staff developed recommended warning language for engine-driven tools, with particular focus on portable generators, as a follow-up to the staff's assessment of the inadequacy of current warnings. This was later provided to the Underwriters Laboratories
(UL)voluntary standard development committee. In February 2006, staff developed a further refined warning label for portable generators and presented it to UL in response to their request for CPSC staff comments on a proposed UL Outline of Investigation. UL incorporated staff 's proposed warning label into their Outline of Investigation, which became effective April 2006 and serves as the requirements with which a product must conform in order to be eligible to bear the UL mark. This document is not a consensus standard. The Commission believes a final rule is needed to ensure that all products will bear the proposed warning label as opposed to only those that seek UL's mark. E. Description of the Rule The warning label appears at fig. 1 (and fig. 3 for the on-package label). The warning label provides technical data, i.e., it indicates the presence of carbon monoxide in the portable generator exhaust and informs that carbon monoxide is a poison you cannot see or smell. The label uses the phrase “you cannot see or smell” rather than terms such as “odorless” and “colorless,” because the latter terminology may be less familiar and understandable to some consumers. The label also includes statements which connect the technical data with safety concerns. Specifically, the label warns: “Using a generator indoors CAN KILL YOU IN MINUTES.” The phrase “in minutes” is intended to emphasize the imminence of the carbon monoxide poisoning hazard to provide consumers with a better understanding of the speed with which incapacitation can occur. In addition, research indicates that information about hazard scenarios affects consumers' risk judgments. Thus, the label includes a description not just of the hazard, carbon monoxide, but of the primary hazard scenario associated with CO-poisoning deaths, i.e., using a generator indoors. The label also warns, “NEVER use inside a home or garage, EVEN IF doors and windows are open.” The label warns specifically against use in the home and in garages, since these are known places in which consumers have used generators. The label includes prescriptive advice to “Only use OUTSIDE and far away from windows, doors, and vents,” so consumers can know what positive action they can take to avoid the hazard, rather than focusing exclusively on prohibited behaviors, or what consumers should not do. This is consistent with the requirements of ANSI Z535.4-2002, which is the primary U.S. voluntary consensus standard on product safety signs and labels, and with warning design guidelines in general. The accompanying pictograms are based on the pictograms developed by the Underwriters Laboratories Standards Technical Panel. Research shows that labels with pictograms tend to capture a consumer's attention more readily than a label without pictograms. F. Unreasonable Risk of Injury Portable generators are powered by gasoline, diesel, or propane engines and exhaust CO. If the generator is used in enclosed or even partially enclosed spaces, the CO can very quickly build to hazardous levels. Serious injury can also result when the generator is placed outdoors but near an open window or vent and the exhaust is pulled into a house. In the 6-year period from 2000 through 2005, the Commission is aware of at least 222 deaths related to CO poisoning associated with generators. 4 Non-fatal CO injuries can have serious consequences since permanent brain or neurological damage can result. 4 Natalie E. Marcy and Debra S. Ascone, “Incidents, Deaths and In-Depth Investigations Associated with Carbon Monoxide from Engine-Driven Generators and other Engine-Driven Tools, 1990-2004,” CPSC Memorandum to Janet Buyer, Directorate for Engineering Sciences, U.S. Consumer Product Safety Commission, Washington, DC (1 December 2005) and Robin L. Ingle, “Non-fire Carbon Monoxide Fatalities Associated with Engine-Driven Generators and Other Engine Driven Tools in 2004 and 2005,” CPSC Memorandum to Janet Buyer, Directorate for Engineering Sciences, U.S. Consumer Product Safety Commission, Washington, DC (3 January 2006). A well-designed warning label should inform the consumer of the CO hazard associated with generators and how to avoid the hazard while using the generator. A label placed in a prominent position on the generator is expected to reinforce this information each time the consumer used the generator. For example, the proposed label reminds the consumer that generator exhaust contains CO, which cannot be seen or smelled, and can quickly kill. The label also clarifies that a generator should only be used outside and far away from windows and vents and should not be used inside a home or garage. This information is important since some consumers have apparently been aware that a CO hazard was associated with generators, but believed that they would avoid the hazard by running the generator in a garage with the door open or outside the house, and did not understand that it was necessary to place it away from open windows and vents. 5 The costs of a warning label include the one-time cost of designing the label and the continuing costs of printing and applying the labels to the generators and packages. These costs are expected to be low—less than one dollar per generator. Based on the hazards associated with carbon monoxide poisoning from portable generators, and the low cost of labeling generators, the Commission finds that there is an unreasonable risk of injury associated with portable generators. 5 Timothy P. Smith, “Human Factors Assessment for the Small Engine-Driven Tools Project,” CPSC Memorandum to Janet L. Buyer, U.S. Consumer Product Safety Commission, Washington, DC (18 June 2002). G. Environmental Considerations The National Environmental Policy Act and the Council on Environmental Quality Act regulations and CPSC procedures for environmental review require the Commission to assess the possible environmental effects associated with the labeling requirement for portable generators. Labeling rules are not expected to have an adverse impact on the environment and are considered to fall within the “categorical exclusions” for the purposes of the National Environmental Policy Act according to the CPSC regulations that cover its “environmental review” procedures (16 CFR Part 1021.5(c)(2)). Thus, the Commission concludes that no environmental assessment or environmental impact statement is required in this proceeding. H. Impact on Small Business When an agency issues a final rule such as the labeling requirement for portable generators, the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 601 *et seq.* , generally requires the agency to prepare a final regulatory flexibility analysis describing the impact of the rule on small businesses and other small entities. Section 605 of the RFA provides that an agency is not required to prepare a regulatory flexibility analysis if the head of an agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The Commission's Directorate for Economic Analysis prepared a preliminary assessment of the impact of a rule to require labeling on portable generators. That assessment reported that, while small manufacturers will be responsible for ensuring that their generators are properly labeled, the labeling requirement is not expected to pose a significant burden to small business because the cost of adding the labels per generator is expected to be less than a dollar per generator set. The incremental cost of the rule issued today is likely to be minimal. Based on the foregoing assessment, the Commission certifies that the rule issued today to require labeling for portable generators will not have a significant adverse impact on a substantial number of small businesses or other small entities. I. Executive Order 12988 As provided for in Executive Order 12988 (February 5, 1996), the CPSC states that the preemptive effect of these regulations is as follows. The preemption provisions of section 26 of the CPSA apply only to “consumer product safety standards.” By definition in the CPSA, section 27(e) rules are not consumer product safety standards. There is, therefore, no express preemption for a final rule under section 27(e) of the CPSA. Preemption of state requirements could still occur if, for example, it is impossible to comply with both this rule and a state requirement. J. Effective Date Part 1407 requires a label on any portable generator manufactured or imported on or after May 11, 2007. 6 6 Note that the rule does not apply to any portable generator that is an “accessory” to a motor vehicle as defined in 49 U.S.C. 30102(a)(7). K. Response to Comments on the NPR In response to the **Federal Register** notice proposing labeling requirements for portable generators, the Commission received 19 comments. The comments were largely positive and supported the proposed labeling, but two comments explicitly requested that the Commission withdraw the NPR. Many of the comments, even those that supported the general intent and approach of the rule, raised specific issues or concerns. 1. Procedural Issues and Choice of Statutes *Comments:* Two comments claim that the Federal Hazardous Substances Act (FHSA), not the CPSA, is the appropriate statute under which to address through labeling the CO-poisoning risk associated with portable generators. If, as the commenters claim, the risk of injury is one which could be eliminated or reduced by action under the FHSA, then the Commission, pursuant to section 30(d) of the CPSA, would have been required to find by rule that it was in the public interest to regulate the risk of injury under the CPSA (“section 30(d) finding”). 7 7 Section 30(d) of the CPSA provides that a risk of injury which is associated with a consumer product and which could be eliminated or reduced to a sufficient extent by action under the Federal Hazardous Substances Act, the Poison Prevention Packaging Act of 1970, or the Flammable Fabrics Act may be regulated under the CPSA only if the Commission by rule finds that it is in the public interest to regulate such risk of injury under the CPSA. These commenters also claim that the label proposed in the NPR appears to be the type of warning that Section 7 of the CPSA contemplates, since the NPR characterizes the risk of CO poisoning associated with generator emission as an “unreasonable risk of injury.” 8 8 Section 7(a) of the CPSA provides that the Commission may promulgate a consumer product safety standard requiring that a consumer product be marked with or accompanied by clear and adequate warnings or instructions. Any requirement of such a standard is to be “reasonably necessary to prevent or reduce an unreasonable risk of injury associated with such product.” Id. *Response:* The FHSA defines “hazardous substance” as including any “substance or mixture of substances which
(I)is toxic * * * if [it] may cause substantial personal injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable handling or use * * *.” Hazardous substances are misbranded if they do not bear the labeling required by section 2(p)(1) of the FHSA, 15 U.S.C. 1261(p)(1). In order to label a product under the authority of the FHSA, the product must constitute or contain a hazardous substance. The commenters analogize the labeling of portable generators to the labeling of charcoal packaging under the FHSA, in that charcoal, when burned, generates carbon monoxide. A significant difference between charcoal and portable generators, however, is that charcoal, as a substance which is toxic, constitutes a hazardous substance, and its packaging is therefore required to be labeled under the FHSA. In contrast, portable generators, when sold, are empty. Portable generators as sold thus do not contain any hazardous substance, or any substance, such as gasoline, that would produce the hazardous substance. A more appropriate analogy to portable generators might be gasoline containers that, when sold empty, are subject to the authority of the CPSA. Because the risk of injury associated with carbon monoxide poisoning from portable generators cannot be eliminated or adequately reduced by action under the FHSA, no finding under section 30(d)of the CPSA is required. Commenters also suggest that the label proposed in the NPR appears to be the type of warning that Section 7 of the CPSA contemplates, since the NPR characterizes the risk of CO poisoning associated with generator emission as an “unreasonable risk of injury.” Section 27(e) of the CPSA authorizes the Commission to issue rules requiring a consumer product manufacturer to provide the Commission and consumers with “performance and technical data related to performance and safety as may be required to carry out the purposes of this Act .” One of the purposes of the CPSA, as provided in section 2(b)(1) of the CPSA, is “to protect the public against unreasonable risks of injury associated with consumer products.” The risk of CO poisoning posed by portable generators was fully addressed in the NPR (71 FR 50003) and the use of section 27(e) to protect the public against risk of injury is completely appropriate. This is not to say that it would be inappropriate to adopt a CO warning label for generators under section 7 of the CPSA. Indeed, the Commission intends to consider that approach in connection with its ongoing generator rulemaking (71 FR 74472). 2. Scope and Definition Issues *Comments:* Two comments address scope and definition issues related to the proposed rule. One comment seeks clarification on whether fuel-cell portable generators are included within the scope of the rule. Another comment proposes that the definition of a “portable generator” reflect the definition within Underwriters Laboratories' Outline of Investigation for Portable Engine-Generator Assemblies, UL 2201. *Response:* The CPSC rule is intended to generally cover the same range of portable generators as UL 2201. Therefore, Section 1407.2(b) is revised to read, “A portable generator is an internal combustion engine-driven electric generator rated no higher than 15 kilowatts and 250 volts that is intended to be moved for temporary use at a location where utility-supplied electric power is not available. It has receptacle outlets for the alternating-current
(AC)output circuits, and may have alternating- or direct-current
(DC)sections for supplying energy to battery charging circuits. ” As specified in this definition, portable generators that are covered under this rule must have an internal combustion engine and receptacle outlets for AC output circuits. (The generator may have other outlets, for example, for low voltage DC accessories.) Fuel-cell portable generators are not be covered by the rule. The rule also does not cover generators that fall within the definition of “motor vehicle equipment,” or otherwise fall outside the Commission's jurisdiction under the CPSA. 3. Effective Date of Rule *Comments:* Three comments from portable generator manufacturers state that they will need at least six months, rather than the 90 days proposed in the NPR, from issuance of the final regulation in the **Federal Register** to comply with the new requirements. *Response:* As noted by the staff of the CPSC Directorate for Economic Analysis, the time and resources required by manufacturers to redesign their portable generator labels are likely to be low since the content and format of the labeling will be specified in the rule. The Commission, therefore, believes that most manufacturers should be able to comply with the requirements within 90 days of publication of the final rule. Nevertheless, some manufacturers may have to reschedule other work and shift resources such as labor from other projects. There would be some costs associated with these adjustments and these costs could be alleviated somewhat by delaying the effective date of the rule. To provide some relief to manufacturers that might have trouble incorporating the label change within 90 days, the Commission has decided to post-pone the effective date of the rule such that the label would be required on any portable generator manufactured or imported 120 days after the publication of the final rule in the **Federal Register** . 4. Labeling Text Issues
(a)Multiple Languages *Comments:* Five comments address the issue of whether the message text of the proposed labeling should also be required in a language other than English. Two comments support the addition of other languages, and one of these suggests that Spanish be the second language to include. Two comments oppose requiring additional languages. The remaining comment does not take a position on the matter, but suggests that Spanish is the appropriate language to include if another language is added. *Response:* The staff's previous analyses of generator-related incident data have revealed no pattern of incidents involving people who could not read English. To confirm this, the staff of the CPSC Directorate for Epidemiology
(EP)selected and thoroughly examined a random sample of 25 out of 150 in-depth investigations into generator-related CO-poisoning deaths that occurred in the 2002 to 2005 time frame. None of the examined investigation reports described the victims’ literacy in English, Spanish, or any other language. Consequently, these investigations provide no basis for concluding that labeling in Spanish would have prevented deaths. According to the 2000 U.S. census, most people who speak a language other than English at home speak Spanish, with Chinese ranking a very distant second (Shin & Bruno, 2003). 9 Additionally, the National Center for Education Statistics
(NCES)has found that about 35 percent of American adults who have below basic literacy in English prose 10 spoke Spanish before starting school; only 9 percent could not speak either English or Spanish (NCES, 2005). Adding Spanish to an English-language warning label, therefore, would be expected to improve its readability among the U.S. population more than adding any other language. Nevertheless, the overall impact of adding Spanish to a label may be small. In the case of portable generators, Synovate DuraTrend TM consumer survey data obtained by the EC staff show that only 5.6 percent of generator purchasers in 2005 were Hispanic. Furthermore, many of these people are likely to be literate in English; for example, less than half of all adult Hispanics in the U.S. have below basic literacy in English prose (NCES, 2005). Thus, Hispanics with below basic literacy in English prose—the sub-population most likely to include individuals who cannot read English yet can read Spanish, and who would potentially benefit the most from the addition of Spanish to the proposed warning label—almost certainly represent less than five percent of all generator purchasers in the U.S., and may comprise substantially less than this. Some of these people may also lack basic literacy in Spanish and, therefore, would be unable to read a label even if it included written Spanish. Despite these findings, the Commission does not dismiss the potential usefulness of providing the information in the labeling in Spanish, especially in regions of the country with large Hispanic populations. Thus, the rule does not prohibit manufacturers from providing a Spanish-language version of the labeling in addition to the prescribed English-language label. If the product label is provided by the manufacturer in additional languages, however, the staff believes that additional-language versions of the label should appear adjacent to or below the English-language version of the product label. This formatting is consistent with ANSI Z535.4—2002, the most recent published version of the American National Standard for Product Safety Signs and Labels. The staff further recommends that any additional-language versions of the label, whether they be on the product or on the generator package, be no larger than the English-language version of the label. Thus, the final rule includes these requirements at § 1407.3(a)(1) and § 1407.3(a)(2). 9 Among the 262.4 million people in the U.S. aged 5 years or older, 47.0 million (18 percent) speak a language other than English at home. About 60 percent of these (28.1 million) speak Spanish and about 0.4 percent (2.0 million) speak Chinese. 10 Those with below basic literacy in English prose lack the skills necessary to perform simple everyday literacy activities such as reading and understanding information in short commonplace continuous texts.
(b)Signal Word Choice *Comments:* Four comments assert that the signal word WARNING is more appropriate than DANGER for the proposed labeling. Arguments made by the commenters include that the use of DANGER is inconsistent with the hierarchy specified in the ANSI Z535 series of standards and that its use might reduce the perceived risk associated with the WARNING hazards of fire during refueling, electrocution from use in wet conditions, and electrocution from connection to a commercial power source. *Response:* According to the ANSI Z535 series of standards, the selection of a signal word for a hazard label should be made based on the seriousness of the hazard situation or scenario. For example, ANSI Z535.4—2002, the most recent published version of the American National Standard for Product Safety Signs and Labels, defines DANGER as an “imminently hazardous situation which, if not avoided, will result in death or serious injury” (Section 4.13.1). The latest revision of ANSI Z535.4 clarifies that use of the term—will” in this definition indicates an event that is nearly, but not absolutely, certain (Annex E, due for publication 2006). While the mere presence of carbon monoxide in portable generator exhaust could lead to death or serious injury, the use of generators indoors—the hazard scenario specifically highlighted in the label—would almost certainly result in death or serious injury due to a generator's high rate of CO production (for example, see Inkster, 2004). The CPSC continues to believe, therefore, that DANGER is the appropriate signal word for the proposed labeling. The Commission cannot confirm the assertion that using DANGER for the CO poisoning hazard would necessarily reduce the perceived hazard associated with the WARNING hazards mentioned. One could argue instead that the use of DANGER simply increases the perceived hazard associated with CO poisoning without having any effect on consumer perceptions related to the other hazards being warned about on the product. Additionally, the selection of a signal word for a given hazard is supposed to be based on the standard signal-word definitions (for example, those used in ANSI Z535.4), which denote the seriousness of the hazard situation or scenario, not on how the signal word might impact the perceptions of hazard labels that use other signal words. To the extent that a hazard situation or scenario is serious enough to demand the use of DANGER, one would expect and hope that people exposed to the hazard label would correctly interpret this as meaning that the hazard situation is more serious than a hazard label that relies on a less serious signal word such as WARNING or CAUTION. Accordingly, the final rule requires that the label include the signal word DANGER.
(c)Message Text Issues *Comments:* Five comments are associated with the specific message text of the proposed labeling. Two comments express concerns that the message text has not been independently tested—for example, through the use of focus groups—and suggest various alternatives to the wording of this text. Both also argue that the phrase, “* * * WILL KILL YOU IN MINUTES” is not accurate. One comment includes the results of focus group testing, performed on low-literacy individuals by a contractor for the U.S. Environmental Protection Agency (EPA), which found that some people had difficulty understanding the phrase “partly enclosed area” and misinterpreted the word “gas” as gasoline. The contractor recommended that “partly enclosed area” be deleted from the label. One comment states that the label does not alert consumers to the symptoms of CO poisoning or refer users to the manual for additional instructions. Another comment states that the phrase, “Please read the manual before use,” is already attached to the generator in another label and that, therefore, the packaging label should be identical to the product label if one is used. One comment recommends the addition of the phrase, “FOR OUTDOOR USE ONLY,” after the initial sentence of the proposed labeling. *Response:* As referenced in the comment summary, above, an independent contractor performed focus group testing on the proposed product label with low literacy individuals as part of the EPA's efforts to develop a flood-cleanup brochure. This testing identified two specific comprehension problems with the message text of the proposed labeling. First, testing revealed that some low-literacy individuals had difficulty understanding the phrase “partly enclosed area.” The available CPSC data on CO poisoning deaths associated with portable generators show that most incidents in which the generator was reportedly used in an enclosed or partially enclosed area occurred either within the home or in a garage or enclosed carport (Marcy & Ascone, 2005). Thus, the staff believes it would be acceptable to remove “partly enclosed area” from the proposed labeling, as recommended by the EPA's contractor. The staff is concerned, however, about simply deleting this phrase, since its absence could mislead some into believing that generators are only hazardous if used in fully enclosed areas. Thus, the staff recommends adding the phrase, “EVEN IF doors and windows are open,” to the end of the revised portion of the warning. The entire relevant statement, therefore, is changed in the final rule from, “NEVER use in the home or in partly enclosed areas such as garages, ” to, “NEVER use inside a home or garage, EVEN IF doors and windows are open.” The testing also revealed that “gas” may be misinterpreted as “gasoline” by some low literacy individuals. To address this comment, the label is revised to read as follows: “Exhaust contains carbon monoxide, a poison gas you cannot see or smell,” with, “Generator exhaust contains carbon monoxide. This is a poison you cannot see or smell.” Because they address the specific comprehension problems identified with the message text during testing, these revisions should make the proposed labeling more understandable to all generator users. The CPSC staff believes that an explanation of the intended function of a portable generator, which the EPA 's testing contractor also recommended adding, is unnecessary for a product label since people who do not know this information are unlikely to purchase, rent, borrow, or otherwise use a portable generator. Thus, the final rule does not include an explanation of the intended function of a portable generator. The staff agrees that the sentence, “Using a generator indoors WILL KILL YOU IN MINUTES,” is questionable because death may occur in a longer time frame than what most people would deem “in minutes” and because generator use indoors may result in severe CO poisoning rather than death. The staff is also concerned that people who have previously used a generator indoors and survived could question the credibility of a label that states death is essentially inevitable. If the label is not credible, people may choose to ignore the safety message. Therefore, the Commission has revised this statement to read, “Using a generator indoors CAN KILL YOU IN MINUTES.” This revision has no effect on the appropriateness of using DANGER as the signal word for this label, as discussed earlier, since the use of generators indoors would still almost certainly result in death or serious injury due to a portable generator's high rate of CO production. The revised phrase simply emphasizes the possibility that death can occur within minutes. In its 2003 memorandum that proposed warning labels to accompany portable generators, the CPSC staff specifically recommended against including a description of CO-poisoning symptoms within the product label because this information would add a substantial amount of text to the label and was believed to be of limited value for a label to be affixed to the product itself (Smith, 2003). The staff continues to support this position. Regarding the statement, “See product manual for more details,” which originally appeared at the bottom of the on-product label in the staff's 2003 memorandum (Smith, 2003), the staff does not believe this statement should be required on portable generators because the information that is provided in the labeling required in this final rule addresses the key safety information of which people must be aware when using a generator and generator manufacturers may include a statement that refers users to the product manual elsewhere on the generator. As pointed out in one public comment, some manufacturers already include the phrase, “ Please read the manual before use,” in other generator labels. For the packaging label, however, the statements, “Avoid other generator hazards. READ MANUAL BEFORE USE,” are needed since this label may very well be the only label on the packaging that will alert the purchaser to possible hazards associated with generator use. Therefore, the provision has been retained in the final rule. The CPSC staff believes it would be inappropriate to add the phrase, “FOR OUTDOOR USE ONLY,” after the initial sentence of the message text in the proposed labeling. Placing this phrase after the initial sentence interrupts the logical flow of the warning from the explanation of the hazard situation to the descriptions of the appropriate hazard avoidance behaviors. A more appropriate location for this phrase, if it were used, would be at the beginning of the message text as the first sentence of the warning. However, the staff is concerned that using this phrase as the first sentence would tend to de-emphasize the description of the hazard situation and its consequences (that is, “Using a generator indoors CAN KILL YOU IN MINUTES.”), could lead people to stop reading further because it is a highly familiar phrase that people are likely to believe they already understand, and is redundant with the already-present and more-detailed admonition to use the generator outside and far away from windows, doors, and vents. Thus, although this statement would not add a substantial amount of text to the label, the Commission does not believe it should be added to the labeling and the statement is not included in the final rule. However, manufacturers are not prohibited from including a statement of this kind elsewhere on the product, packaging, or product manual. 5. Labeling Pictogram and Symbol Issues
(a)Prohibition Symbol Choice *Comments:* Four comments propose the use of a circle-slash symbol rather than an “X” symbol to indicate prohibited actions in the pictograms that appear in the proposed labeling. Arguments made within these comments in favor of the circle-slash symbol include the fact that it is consistent with the ANSI Z535 series of standards, is internationally recognized, and obscures less of the underlying pictogram than an “X.” One comment states that a transparent circle-slash symbol may be superior since it does not obscure the underlying pictorials. *Response:* The CPSC staff acknowledges that the ANSI Z535 series of standards recommends the use of a circle-slash symbol to indicate prohibited actions in pictograms. When developing the proposed labeling, the CPSC staff chose to use “X” symbols rather than circle-slash symbols because both the circle-slash and “X” symbols are commonly recognized as conveying the prohibition concept (Dreyfuss, 1972; Wogalter & Leonard, 1999), there was no evidence that English-reading consumers would have difficulty understanding the meaning of an “X” symbol, and the only known evidence of comprehension problems with either prohibition symbol were those encountered with the circle-slash symbol by some Latin American individuals during charcoal-pictogram testing previously performed for the CPSC (Requirements for Labeling of Retail Containers of Charcoal, 1996). The staff also found that circle-slash symbols tended to obscure more of the underlying pictograms than did “X” symbols of the same size. For example, the circle portion of the circle-slash symbols tended to obscure the outlines of the home and garage pictograms, making these portions of the pictograms difficult to discern. Since publication of the **Federal Register** notice regarding the NPR, the staff has become aware of an internal Douglas Aircraft research report that identified possible comprehension problems with the use of an “X” to indicate prohibition. For example, the researchers found that a graphic using an “X” to indicate that a part should not be touched was misinterpreted by some as meaning the opposite, indicating where the person should touch (Johnson, 1974, as cited in Johnson, 2006). In light of this research, the staff agrees that the use of “X” symbols rather than circle-slash symbols to indicate prohibition in the proposed labeling may not be preferable. The final rule, therefore, includes the opaque circle-slash symbols rather than “X” symbols. Additionally, to avoid problems with the circle-slash obscuring the outlines of the home and garage, the final rule uses smaller circle-slash symbols, centered over the generator pictograms. Although a transparent circle-slash symbol would not obscure the underlying symbol, its use is inconsistent with the prohibition symbol recommended in the ANSI Z535 series of standards.
(b)Use of Hazard-Avoidance Pictograms *Comments:* Three comments are associated with the staff's decision to use pictograms depicting hazard avoidance behavior in the proposed labeling. Two comments state that these pictograms have not been independently tested, and question whether the pictograms of the generator will be readily recognized. One of these comments suggests that the standard hazardous gas/vapors pictogram, which shows a person inhaling gas, might be a better choice since it had undergone successful consumer testing. One comment, which includes the results of EPA-sponsored focus group testing on the proposed product label, reports that some low-literacy individuals had difficulty recognizing the generator pictogram. The contractor recommended enlarging this pictogram to improve the likelihood that it will be correctly identified. *Response:* The CPSC staff had originally considered the use of the hazardous gas/vapors pictogram referred to in the comments, but expressed reservations about its use since the gas in the pictogram is visible even though carbon monoxide is not (Smith, 2003, 2006). The staff continues to be concerned about this potential for confusion. In addition, although testing has revealed that most people can recognize the referenced pictogram as indicating hazardous gas or vapors (Mayer & Laux, 1989), this pictogram provides no information regarding appropriate hazard-avoidance behaviors. In fact, since this pictogram could indicate hazardous gases with varying degrees of lethality, the appropriate hazard-avoidance behavior may vary substantially among different hazardous gases. For example, some products that release hazardous gases might be safely used within an open garage, but this is not true for an operating portable generator. The final rule uses pictograms depicting appropriate and inappropriate behaviors specific to portable generators to avoid this ambiguity. As discussed earlier, an independent contractor performed focus-group testing on the proposed product label with low-literacy individuals as part of the EPA's efforts to develop a flood-cleanup brochure. The only identified problem with the pictograms that appear in the proposed labeling was that some people had difficulty recognizing the graphic of the generator. These test results, however, almost certainly underestimate the extent to which the generator graphic would be recognized in a real-life scenario. For example, testing was not performed with the label affixed to a generator. When presented in the appropriate context, generator graphics are more likely to be recognized (Wogalter, Silver, Leonard, & Zaikina, 2006). Additionally, the EPA testing found that some of the participants in the testing did not even know what a generator was. People who do not know the intended function of a portable generator are unlikely to purchase, rent, borrow, or otherwise use a portable generator, and would not be expected to correctly identify a graphic of this product. Nevertheless, to improve the likelihood that people will correctly identify the generator graphic as a portable generator and to increase the overall legibility of the pictograms, the CPSC has slightly increased the size of the pictograms in the final rule, as recommended by the EPA's testing contractor. The Commission also notes that Section 1407.3(a)(1) of the final rule specifies that “[a] different representation of the generator [within the proposed labeling] may be substituted for accuracy if consumers are more likely to recognize the substituted representation as the generator to which this label is affixed.” Manufacturers, therefore, may substitute a graphic of the specific generator to which the label will be affixed if they so choose.
(c)Other Hazard-Avoidance Pictogram Issues *Comments:* Five comments are associated with specific features of the hazard-avoidance pictograms that appeared within the proposed labeling. Two comments suggest deleting the symbol depicting the use of a generator within a garage. This pictogram, according to three comments, could be interpreted as meaning that one should not store the generator in a garage. Two comments claim that the two-headed arrow graphic that appears in the pictogram depicting appropriate behavior could be misinterpreted. One of these states that the two-headed arrow graphic could be interpreted as meaning that use both in and away from the home is acceptable; the commenter suggests that this arrow be replaced with a single-headed arrow that points away from the home. The other comment claims that this graphic could be interpreted as meaning that the person should connect the generator by electrical wire to a commercial power supply as a backup, and recommended deleting the pictogram entirely. *Response:* The Commission believes that both pictograms that depict inappropriate behaviors—one showing generator use within a home or enclosed space and one showing generator use within a garage—are necessary to convey the key safety message. Relying solely on the pictogram of the generator within a home or enclosed space to indicate inappropriate behavior, as recommended by the commenters, could lead people to believe that generators are only hazardous if used within a completely enclosed space. Many CO-poisoning deaths associated with portable generators occurred when the generator was being used in a garage with the door at least partially open. The pictogram depicting generator use in the garage as being inappropriate directly addresses incidents of this type. Although the CPSC acknowledges that one could infer from these pictograms that generators should not be stored in the home or garage, alternative pictograms such as the poisonous gas/vapors pictogram are also open to various interpretations regarding appropriate and inappropriate behaviors specific to portable generators, as discussed in the response to the previous topic. As demonstrated by the earlier discussion of comprehension problems encountered with common prohibition symbols, virtually no hazard pictogram or symbol will be understood by all people. For this reason, explanatory text is very often recommended or required, 11 especially for complex hazards (Wogalter, Silver, Leonard, & Zaikina, 2006). The CPSC believes that the explanatory message text that appears in the label should limit the extent to which misinterpretations of the pictograms would prevent people from understanding the overall message of the labeling. 11 ANSI Z535.3-2002 requires explanatory text for any symbol without demonstrated understandability; for example, one that is not understood by at least 85 percent of the target audience using the methodology specified in Annex B of the standard. Research suggests that few safety symbols can meet this requirement, so accompanying text is almost always required. Regarding the use of a double-headed arrow in the pictogram depicting the appropriate use of a portable generator, the American National Standard Criteria for Safety Symbols, ANSI Z535.3, recommends the consistent use of arrow graphics to represent different types of movement or spatial relationships. Single-headed arrows are used to represent the motion of objects or components or to represent the exertion of pressure or force; in contrast, double-headed arrows are used to represent the idea of keeping a safe distance away from a hazard (ANSI Z535.3-2002, Figure A1). Thus, the use of a double-headed arrow is appropriate, and the direct replacement of the double-headed arrow with a single-headed one, as recommended by one commenter, would suggest the movement of the home toward the generator, which is opposite the intended meaning and could create critical confusion among the intended audience. Despite this, in the final rule issued today, the original appropriate-use pictogram is replaced with a pictogram that avoids the possible misinterpretations identified by the commenters yet remains consistent with ANSI Z535.3. This pictogram employs a single-headed arrow but places the arrow on the opposite side of the generator pictogram to suggest the movement of the generator away from the home. The length of the arrow has also been shortened so the generator pictogram is not located immediately adjacent to the graphic of the home. 6. Explicit Safe Distance *Comments:* Six comments point out that the proposed labeling does not include an explicit distance (for example, measured in feet) that should be maintained between the generator and the home or other partially enclosed area. Some suggest that this distance could be inserted within the message text or within the pictogram depicting the generator being kept away from the home. One comment suggests a minimum distance of 10 feet; another comment suggests at least 15 feet. *Response:* The CPSC agrees that explicitly identifying a safe operating distance between the generator and the home or other partially enclosed area would be more useful than relying on terms such as “far,” but has been unable to develop a consensus as to what distance is adequate given the widely varying conditions under which portable generators may be used. As discussed in the staff's 2006 briefing package on portable generator safety, some portable generator manufacturers currently provide minimum clearance requirements for placement of the generator; however, these distances appear to represent the clearances needed to allow for adequate combustion and cooling airflow, not to avoid CO poisoning (Buyer, 2006). Variables such as the speed and direction of wind relative to openings to indoor spaces and the relative proximity of other structures to the generator complicate attempts to define a reasonably safe distance. In a study of nonfatal CO-poisoning incidents following two major hurricanes in 2005, the Centers for Disease Control and Prevention
(CDC)found that half of those interviewed who had been involved in generator-related incidents had placed the generator outside in the open, but that all of these individuals had placed the generator within seven feet of the home (CDC, 2006). Thus, a “reasonably safe” distance likely would be greater than seven feet. However, available data do not allow the Commission to reach consensus on how much farther than seven feet would constitute a reasonably safe distance. The phrase “far away,” used in the label required by this final rule, while not as explicit as a specified distance, still emphasizes the need to keep the generator well away from, rather than immediately outside, the home or other partially enclosed areas. 7. Labeling Placement *Comments:* Three comments address the proposed location or placement of the label on the product. Two comments state that it is not technically feasible to meet a requirement that the label be placed on a part of the generator that, if removed, would impair the operation of the generator. The commenters propose an alternative requirement that the label be placed on a part of the portable generator that cannot be removed without the use of tools. One comment suggests that the label be located close to the “on/off” switch, the starter, or the power outlets, and suggests that the label be more “active” by requiring the user to take an action that draws attention to the label each time the generator is used. *Response:* The Commission is not opposed to the commenters' proposed alternative requirement that the label be placed on a part that cannot be removed without the use of tools. Therefore, section 1407.3(a)(1)(iii)(A) of the final rule states, “On a part of the portable generator that cannot be removed without the use of tools.” Regarding the comment about making the label more “active” by requiring the user to take an action that draws attention to the label each time the generator is used, the Commission believes that such a requirement is unnecessary at this time since the label is already required to be placed in a location that is prominent and conspicuous to an operator while performing at least two of the following tasks: Filling the fuel tank, accessing the receptacle panel, and starting the engine (see section 1407.3(a)(1)(iii)(B) of the final rule). 8. Need for Packaging Label *Comments:* Two comments propose that the requirement for a packaging label be dropped from the rule. Both believe this label is unnecessary since the packaging will be discarded. *Response:* The intent of the packaging label is to directly provide potential purchasers of portable generators with information at the point of purchase emphasizing the danger of CO poisoning, and to reinforce the warning when the generator is removed from the packaging at home, not to assist consumers while they are operating the generator after the packaging is discarded. The packaging label provides the CO poisoning information irrespective of sales staff interaction or other messaging at the point of sale. Without the information presented by the packaging label, purchasers may not discover until they are home that they do not have an appropriate place to operate the generator. Accordingly, the proposed requirement for the packaging label is retained in this final rule. 9. Missing Manual Warning *Comments:* One comment notes that a previous CPSC staff memo included a recommendation for a product-manual warning, which included information about CO-poisoning symptoms, and that the NPR does not include a recommendation for such a warning. *Response:* The rule does not include specific recommendations for CO-poisoning warnings to appear within the manuals that accompany portable generators because prior analyses of the CO-poisoning information provided on the product and within the product manuals found that the product labeling was often far more deficient (Smith, 2002). Since the on-product labeling is available to consumers even after the product manual is lost, discarded, or otherwise not available, improved product labels are of paramount importance. The Commission does agree, however, that providing more detailed information about CO poisoning within the product manual, including information about the symptoms of CO poisoning, would be advantageous, and the staff may consider additional requirements of this type as part of the CPSC 's ongoing activities associated with improving portable generator safety. 10. Extension Cord Warning *Comments:* One comment notes that increasing the distance between the generator and any partially enclosed spaces necessarily increases the distance between the generator and the load, which could result in some consumers using extension cords with insufficient capacity. The commenter suggests that a warning label that states, “ONLY USE PROPERLY SIZED EXTENSION CORDS IN GOOD CONDITION,” be affixed to the generator's electrical panel. *Response:* The Commission agrees that the capacity and condition of extension cords to be used with portable generators must be adequate to support the intended load and allow the generator to be kept far away from homes and other partially enclosed areas. However, this issue is outside the scope of this rulemaking. 11. Alternatives to Labeling *Comments:* Three comments suggest that labeling alone is not sufficient to address the CO-poisoning hazard and recommend technical solutions such as reduced CO emissions or integrated CO monitors that will automatically shut off the generator if necessary. *Response:* Specific technical approaches to addressing the CO poisoning hazard associated with portable generators are outside the scope of this rule and are addressed in a separate Commission rulemaking commenced with the recent publication of an advance notice of proposed rulemaking, 71 FR 74472 (December 12, 2006). L. Conclusion For the reasons stated in this preamble, the Commission finds that a requirement for a carbon monoxide warning statement on portable generators is necessary to help protect the public against the risk of CO poisoning associated with such products. List of Subjects in 16 CFR Part 1407 Consumer protection, labeling. Therefore, for the reasons stated in the preamble, the Commission amends Title 16 of the Code of Federal Regulations by adding a new Part 1407 to read as follows: PART 1407—PORTABLE GENERATORS: REQUIREMENTS TO PROVIDE PERFORMANCE AND TECHNICAL DATA BY LABELING Sec. 1407.1 Purpose, scope, and effective date. 1407.2 Definitions. 1407.3 Providing performance and technical data to purchasers by labeling. Authority: 15 U.S.C. 2076(e). § 1407.1 Purpose, scope, and effective date. This part 1407 establishes requirements under section 27(e) of the Consumer Product Safety Act (15 U.S.C. 2076(e)) for manufacturers to provide consumers with a specified notification concerning the carbon monoxide poisoning hazard associated with the use of portable generators. The notification is intended to provide consumers with technical and performance information related to the safety of portable generators. This part applies to any generator manufactured or imported on or after May 14, 2007. § 1407.2 Definitions.
(a)The definitions in section 3 of the Consumer Product Safety Act (15 U.S.C. 2052) apply to this part 1407.
(b)A portable generator is an internal combustion engine-driven electric generator rated no higher than 15 kilowatts and 250 volts that is intended to be moved for temporary use at a location where utility-supplied electric power is not available. It has receptacle outlets for the alternating-current
(AC)output circuits, and may have alternating- or direct-current
(DC)sections for supplying energy to battery charging circuits. § 1407.3 Providing performance and technical data to purchasers by labeling.
(a)Notice to purchasers. Manufacturers of portable generators shall give notification of performance and technical data related to performance and safety to prospective purchasers of such products at the time of original purchase and to the first purchaser of such product for purposes other than resale, in the manner set forth below.
(1)On-product label. The CO poisoning hazard label shown in fig. 1 shall be used on the product. A different representation of the generator may be substituted for accuracy if consumers are more likely to recognize the substituted representation as the generator to which this label is affixed. Alternate-language versions of this label may appear on the product in addition to the label specified in figure 1. If the product label is also provided by the manufacturer in additional language(s), it shall appear adjacent to or below the English-language version of the product label, and shall be no larger than the English-language version of the label. Versions of the product label that are in a language other than English may appear without the pictograms that appear in the English-language versions.
(i)The signal word “DANGER” shall be in letters not less than 0.15 inch (3.8 mm) high. The remaining text shall be in type whose uppercase letters are not less than 0.1 inch (2.5 mm) high.
(ii)The signal word “DANGER” shall appear in white letters on a safety red background. The safety alert symbol shown in fig. 2 shall appear immediately before and next to the signal word and be no smaller than the height of the signal word with the base of the triangle on the same horizontal line as the base of the signal word. The solid portion of the triangle (within the lines of the triangle, around the exclamation mark) shall be white and the exclamation mark shall be safety red. The prohibition circle-slash symbols shall be opaque.
(iii)The on-product hazard label shown in fig. 1 shall be located:
(A)On a part of the portable generator that cannot be removed without the use of tools, and
(B)On a location that is prominent and conspicuous to an operator while performing at least two of the following actions: Filling the fuel tank, accessing the receptacle panel, and starting the engine.
(iv)The on-product hazard label shown in fig. 1 shall be designed to remain permanently affixed, intact, legible, and largely unfaded in the environment in which the product is expected to be operated and stored over the life of the product.
(2)Carbon monoxide poisoning hazard label for package. The CO poisoning hazard label shown in fig. 3 shall be affixed to the principal display panel(s) of the package, as well as the surface containing the top flaps of the package. The principal display panel(s) of the package is the portion(s) of the outer packaging that is designed to be most prominently displayed, shown, presented, or examined under conditions of retail sale. Any panel of the package that includes text in a language other than English shall also include a CO poisoning hazard label in that language. Alternate-language versions of the label, in addition to the label specified in figure 3, may also appear on the top flaps of the package as long as they are physically separate from one another. A different representation of the generator may be substituted for accuracy if consumers are more likely to recognize the substituted representation as the generator contained within the packaging.
(i)The signal word “DANGER” shall be in letters not less than 0.15 inch (3.8 mm) high. The remaining text shall be in type whose uppercase letters are not less than 0.1 inch (2.5 mm) high.
(ii)The signal word “DANGER” shall appear in white letters on a safety red background. The safety alert symbol shown in fig. 2 shall appear immediately before and next to the signal word and be no smaller than the height of the signal word with the base of the triangle on the same horizontal line as the base of the signal word. The solid portion of the triangle (within the lines of the triangle, around the exclamation mark) shall be white and the exclamation mark shall be safety red. The prohibition circle-slash symbols shall be opaque.
(b)[Reserved] ER12JA07.001 ER12JA07.002 ER12JA07.003 Note: The following appendix will not appear in the code of Federal Regulations. Appendix—List of Relevant Documents 1. Memorandum from Timothy P. Smith, Engineering Psychologist, Division of Human Factors, Directorate for Engineering Sciences, to Janet L. Buyer, Project Manager, Division of Combustion and Fire Sciences, Directorate for Engineering Sciences, “Product labels for generators to address carbon monoxide poisonings,” May 26, 2006. 2. Memorandum from Robert Franklin, Economist, Directorate for Economic Analysis,“Economic Issues Related to a CO Warning Label on Portable Generators,” December 27, 2006. 3. Memorandum from Natalie E. Marcy, Mathematical Statistician, Division of Hazard Analysis, Directorate of Epidemiology, and Debra S. Ascone, Mathematical Statistician, Division of Hazard Analysis, Directorate for Epidemiology, to Janet Buyer, Project Manager, Division of Combustion and Fire Sciences, Directorate for Engineering Sciences, “ Incidents, Deaths, and In-Depth Investigations Associated with Carbon Monoxide from Engine-Driven Generators and Other Engine-Driven Tools, 1990-2004,” December 1, 2005. 4. Memorandum from Robin L. Ingle, Health Statistician, Division of Hazard Analysis, Directorate for Epidemiology, to Janet Buyer, Project Manager, Division of Combustion and Fire Sciences, Directorate for Engineering Sciences, “Non-fire Carbon Monoxide Fatalities Associated with Engine-Driven Generators and Other Engine-Driven Tools in 2004 and 2005,” January 13, 2006. 5. Memorandum from Robert Franklin, Directorate for Economic Analysis, “Effective Date of CO Warning Label for Generators—Response to Comments,” December 27, 2006. Dated: January 5, 2007. Todd A. Stevenson, Secretary, Consumer Product Safety Commission. [FR Doc. 07-80 Filed 1-11-07; 8:45 am]
Connectionstraces to 41
Traces to 41 documents
U.S. Code
- Findings§ 7701
- Price support§ 1421
- Purposes§ 3501
- Rule making§ 553
- Avoidance of duplicative or unnecessary analyses§ 605
- Definitions§ 601
- Public information; agency rules, opinions, orders, records, and proceedings§ 552
- Determination of other material as special nuclear material; Presidential assent; effective date§ 2071
- Establishment and transfers§ 5841
- Licensing of uranium enrichment facilities§ 2243
- Authority and functions of Director§ 3504
- Definitions§ 2403
- Policies contained in international arrangements§ 2152
- Foreign distribution of special nuclear material§ 2074
- Cooperation with other nations§ 2153
- Inalienability of licenses§ 2234
- Revocation of licenses§ 2236
- Effect of international arrangements§ 2151
- Federal Aviation Administration§ 106
- Congressional findings and declaration of purpose§ 2051
- Prohibited acts§ 2068
- Civil penalties§ 2069
- Definitions§ 30102
- Definitions§ 1261
- Additional functions of Consumer Product Safety Commission§ 2076
- Definitions§ 2052
register
CFR
- Embargoed destinations.§ 110.28
- Restricted destinations.§ 110.29
- Criterion for categorical exclusion; identification of licensing and regulatory actions eligible for categorical exclusion or otherwise not requiring environmental review.§ 51.22
- NRC size standards.§ 2.810
- May I address the unsafe condition in a way other than that set out in the airworthiness directive?§ 39.19
- What is the legal effect of failing to comply with an airworthiness directive?§ 39.7
- Application.§ 21.303
- Applicability.§ 71.1
- Thermal/Acoustic insulation materials.§ 25.856
- Categories of CPSC actions.§ 1021.5
39 references not yet in our index
- 7 CFR 301
- 7 CFR 301.75-1
- 7 USC 7701-7772
- 7 CFR 2.22
- Pub. L. 106-113
- Pub. L. 106-224
- 114 Stat. 400
- 7 CFR 3015
- 7 USC 8301-8317
- 10 CFR 110
- Pub. L. 104-113
- 68 Stat. 929
- 88 Stat. 1242
- Pub. L. 101-575
- 104 Stat. 2835
- 112 Stat. 2750
- Pub. L. 96-92
- 93 Stat. 710
- 68 Stat. 939
- 88 Stat. 473
- Pub. L. 99-440
- 92 Stat. 142
- 68 Stat. 954
- 68 Stat. 955
- Pub. L. 102-496
- 14 CFR 39
- 1 CFR 51
- 14 CFR 21
- 14 CFR 71
- 14 CFR 73
- 14 CFR 121
- 49 CFR 121.312(e)(3)
- Pub. L. 96-354
- Pub. L. 96-39
- Pub. L. 104-4
- 110 Stat. 3213
- 14 CFR 125
- 14 CFR 135
- 16 CFR 1407
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