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Code · REGISTER · 2008-07-17 · Agency Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41081-41084 E8-15666 Assessing the Impact of the Patient Safe · Unknown

Unknown. Final rule

49,054 words·~223 min read·/register/2008/07/17/08-1440

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--- schema: federal-register doc_type: fedreg source_file: FR-2008-07-17.xml --- 73 138 Thursday, July 17, 2008 Contents Agency Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41081-41084 E8-15666 Assessing the Impact of the Patient Safety Improvement Corps Training Program; Correction, 41085 E8-16062 Agriculture Agriculture Department See Food Safety and Inspection Service See Forest Service NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 41026 E8-16362 Edward R. Madigan U.S. Agricultural Export Excellence Board of Evaluators: Nominations, 41026-41027 E8-16382 Antitrust Antitrust Division NOTICES Proposed Final Judgment and Competitive Impact: United States of America v. Signature Flight Support Corporation and Hawker Beechcraft Services, Inc., 41118-41126 E8-16254 Centers Centers for Disease Control and Prevention NOTICES Meetings: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel;
Correction, 41085 E8-16340 Centers Centers for Medicare & Medicaid Services See nspector General Office, Health and Human Services Department Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41085-41087 E8-16180 E8-16183 E8-16197 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration Corporation Corporation for National and Community Service NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 41042-41043 E8-16334 Defense Defense Department NOTICES Arms Sales Notification, 41043-41047 E8-15780 Education Education Department NOTICES Federal Family Education Loan Program (FFELP), 41048-41050 E8-16241 Energy Energy Department See Federal Energy Regulatory Commission NOTICES Application to Export Electric Energy: Royal Bank of Canada, 41051 E8-16366 EPA Environmental Protection Agency RULES Approval and Promulgation of Air Quality Implementation Plans:
Maryland; Amendments to the Control of Volatile Organic Compound Emissions from Portable Fuel Containers, 40970-40972 E8-16021 Texas; Control of Air Pollution from Volatile Organic Compounds, 40972-40977 E8-15729 National Emission Standards for Hazardous Air Pollutants: Organic Liquids Distribution (Non-Gasoline), 40977-40982 E8-16320 PROPOSED RULES Approval and Promulgation of Air Quality Implementation Plans: Texas; Control of Air Pollution from Volatile Organic Compounds, 41007 E8-15728 NOTICES Adequacy Status: 2008 and 2009 8-Hour Ozone Motor Vehicle Emission Budgets for Transportation Conformity Purposes for New Jersey, 41068-41069 E8-16390 Clean Water Act Section 303(d):
Availability of List Decisions, 41069 E8-16387 Guidelines for the Award of Monitoring Initiative Funds under Section 106 Grants to States, Interstate Agencies, and Tribes, 41069-41076 E8-16385 Protection of Stratospheric Ozone: Information Concerning the Destruction of Ozone-Depleting Substances in the United States; Data Availability, 41076-41078 E8-16384 Executive Executive Office of the President See Management and Budget Office See Presidential Documents FAA Federal Aviation Administration RULES Airworthiness Directives: 328 Support Services GmbH Dornier Model 328 100 and 300 Airplanes, 40955-40958 E8-15709 Agusta S.p.A.
Model A109E and A119 Helicopters, 40960-40962 E8-14727 Airbus Model A330-200 and A340-300 Series Airplanes, 40958-40960 E8-15708 Boeing Model 747 400 and 747 400D Series Airplanes, 40953-40955 E8-15710 Empresa Brasileira de Aeronautica S.A. (EMBRAER) Model EMB 120, 120ER, 120FC, 120QC, and 120RT Airplanes, 40962-40965 E8-15969 Fokker Model F27 Mark 050 Airplanes, 40948-40951 E8-15711 Pacific Aerospace Limited Model FU-24 Airplanes, 40951-40953 E8-16191 NOTICES Approval of Noise Compatibility Program:
Ocala International Airport, Ocala, FL, 41154-41156 E8-15954 Operating Limitations For Unscheduled Operations at John F. Kennedy International Airport and Newark Liberty International Airport, 41156-41162 E8-15961 Passenger Facility Charge Approvals and Disapprovals, 41162-41164 E8-15958 Petition for Exemption Received, 41164-41165 E8-16248 E8-16249 FCC Federal Communications Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41078-41079 E8-16321 FDIC Federal Deposit Insurance Corporation RULES Large-Bank Deposit Insurance Determination Modernization, 41180-41211 E8-15492 Processing of Deposit Accounts in the Event of an Insured Depository Institution Failure, 41170-41180 E8-15493 Federal Election Federal Election Commission NOTICES Meetings;
Sunshine Act, 41080 E8-16182 Federal Energy Federal Energy Regulatory Commission NOTICES Application for Temporary Amendment of License and Soliciting Comments, Motions to Intervene, and Protests: Alcoa Power Generating Inc., 41051-41052 E8-16293 Application to Amend License and Soliciting Comments, Motions to Intervene, and Protests: Appalachian Power Co., 41052-41053 E8-16290 Combined Notice of Filings, 41053-41061 E8-16306 E8-16307 E8-16308 E8-16309 Declaration of Intention and Soliciting Comments, Protests, and/or Motions to Intervene:
Crane & Company, 41061-41062 E8-16300 Gary E. Hall, 41062-41063 E8-16299 HPML LLC, 41063-41064 E8-16301 John Werner, 41064 E8-16302 Filing: PacifiCorp, 41064-41065 E8-16298 Market-Based Rate Filing: Brookfield Renewable Energy Marketing US, LLC, 41065 E8-16297 Preliminary Permit Accepted for Filing and Soliciting Comment, Motions to Intervene, and Competing Applications: City and Borough of Sitka, 41066 E8-16292 Pacific Gas and Electric Co., 41065-41066 E8-16291 Preliminary Permit Application Accepted for Filing and Soliciting Comment, Motions to Intervene, and Competing Applications:
Lock 12 Hydro Partners, 41066 E8-16295 Lock 14 Hydro Partners, 41066-41067 E8-16296 Pacific Gas and Electric Co., 41067 E8-16294 Workshop on Regulatory Compliance, 41067 E8-16303 Federal Highway Federal Highway Administration NOTICES Environmental Impact Statements; Availability, etc.: St. Lucie County, FL, 41165 E8-16342 Environmental Impact Statements; Notice of Intent: Stone, Perry, George, and Greene Counties, MS, 41165-41166 E8-16371 Final Federal Agency Actions on Proposed Highway in Idaho, 41166 E8-16052 Rescind a Notice of Intent to Prepare an Environmental Impact Statement:
Ada and Canyon Counties, Idaho, 41166-41167 E8-16053 Federal Railroad Federal Railroad Administration PROPOSED RULES Railroad Workplace Safety: Adjacent-Track On-Track Safety for Roadway Workers, 41214-41230 E8-16140 Federal Reserve Federal Reserve System NOTICES Change in Bank Control Notices: Acquisition of Shares of Bank or Bank Holding Companies, 41080 E8-16378 Proposals to Engage in Permissible Nonbanking Activities or to Acquire Companies that are Engaged in Permissible Nonbanking Activities, 41080 E8-16377 Federal Retirement Federal Retirement Thrift Investment Board NOTICES Meetings;
Sunshine Act, 41080 08-1443 FTC Federal Trade Commission PROPOSED RULES Disclosures Regarding Energy Consumption and Water Use of Certain Home Appliances and Other Products, etc., 40988-40992 E8-16283 Financial Financial Management Service See Fiscal Service Fiscal Fiscal Service NOTICES Rate for use in Federal Debt Collection and Discount and Rebate Evaluation, 41167 E8-16250 Fish Fish and Wildlife Service RULES Revision of Regulations Implementing the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES);
Import and Export of Sturg, 40983-40986 E8-16195 PROPOSED RULES Endangered and Threatened Wildlife and Plants: 12-Month Finding on Petition to Delist Astragalus magdalenae var. peirsonii (Peirson's milk-vetch), 41007-41022 E8-16041 Revision of Regulations Implementing the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES); Import and Export, 41022-41025 E8-16198 NOTICES Final Comprehensive Conservation Plan for the Laramie Plains National Wildlife Refuges, Wyoming, 41106-41107 E8-16352 Food Food and Drug Administration RULES Medical Devices;
Radiology Devices; Reclassification of Bone Sonometers, 40967-40970 E8-16354 NOTICES Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunod, 41087-41088 E8-16395 Medical Devices and Radiology Devices: Class II Special Controls Guidance Document: Bone Sonometers— Guidance for Industry and Food and Drug Administration Staff, 41088-41089 E8-16094 Small Entity Compliance Guide:
Standard of Identity for White Chocolate; Availability, 41090 E8-16394 Small Entity Compliance Guide; Availability: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk, 41089-41090 E8-16396 Food Food Safety and Inspection Service RULES Availability of Lists of Retail Consignees during Meat or Poultry Product Recalls, 40939-40948 E8-16221 Forest Forest Service PROPOSED RULES Law Enforcement Support Activities, 41003-41007 E8-16129 NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 41027-41028 E8-16361 Environmental Impact Statements; Notice of Intent: Santa Fe National Forest, NM; Motorized Travel Management Plan, 41028-41030 E8-16374 Meetings: Ravalli County Resource Advisory Committee, 41030 E8-16220 Santa Rosa and San Jacinto Mountains National Monument Advisory Committee, 41030-41031 E8-16337 Proposed New Fee Sites: Federal Lands Recreation Enhancement Act, (Title VIII, Pub. L. 108-447), 41031 E8-16383 Solitation of Interest in Environmental Study:
Rosemont Copper Project, Coronado National Forest, Pima County, AZ, 41031-41032 E8-16314 GSA General Services Administration NOTICES 2008 Travel and Relocation Innovation Award, 41080-41081 E8-16355 GSA Bulletin FTR 08-05: Federal Travel Regulation (FTR); Reimbursement of Fees Associated with Airport Security Fast Pass Memberships, 41081 E8-16356 Geological Geological Survey NOTICES Meetings: Scientific Earthquake Studies Advisory Committee, 41107 E8-16043 Health Health and Human Services Department See Agency for Healthcare Research and Quality See Centers for Disease Control and Prevention See Children and Families Administration See Food and Drug Administration See Health Resources and Services Administration See Indian Health Service See Inspector General Office, Health and Human Services Department See National Institutes of Health Health Health Resources and Services Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 41091 E8-16358 Meetings: Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children, 41091 E8-16360 Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41102-41105 E8-16325 E8-16326 E8-16327 E8-16328 Privacy Act; Systems of Records, 41105-41106 E8-16339 Indian Indian Affairs Bureau NOTICES Environmental Impact Statements; Availability, etc.:
Clark County, WA, 41107-41108 E8-16398 Indian Indian Health Service NOTICES Competitive Targeted Solicitation Funding Opportunity, 41092-41096 E8-16051 Organization, Functions, and Delegations of Authority; Part G, 41096-41097 E8-16353 Inspector Inspector General Office, Health and Human Services Department RULES Medicare and State Health Care Programs: Fraud and Abuse; Issuance of Advisory Opinions by the OIG, 40982-40983 E8-15777 Inter-American Inter-American Foundation NOTICES Meetings;
Sunshine Act, 41106 08-1444 Interior Interior Department See Fish and Wildlife Service See Geological Survey See Indian Affairs Bureau See Land Management Bureau See Minerals Management Service IRS Internal Revenue Service PROPOSED RULES Information Reporting Requirements under Internal Revenue Code Section 6039, 40999-41003 E8-16177 International International Trade Administration NOTICES Export Trade Certificate of Review, 41032 E8-16285 Meetings: Manufacturing Council, 41032-41033 E8-16284 Preliminary Results of Antidumping Duty Administrative Review:
Tapered Roller Bearings and Parts Thereof, Finished and Unfinished; Peoples Republic of China, 41033-41040 E8-16376 International International Trade Commission PROPOSED RULES Revised Procedures and Requests for Information During Adequacy Phase of Five-Year Reviews, 40992-40997 E8-16282 NOTICES Investigation Determination: Carbon and Certain Alloy Steel Wire Rod from Brazil et al., 41116 E8-16287 Investigations: Acetic Acid, 41116-41117 E8-16280 Hand-Held Meat Tenderizers, 41117 E8-16281 Variable Speed Wind Turbines and Components, 41117-41118 E8-16279 Justice Justice Department See Antitrust Division NOTICES Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation and Liability Act, 41118 E8-16392 Labor Labor Department NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 41126-41128 E8-16318 E8-16323 Land Land Management Bureau NOTICES Alaska Native Claims Selection, 41108 E8-16347 Meetings: Santa Rosa and San Jacinto Mountains National Monument Advisory Committee, 41030-41031 E8-16337 Temporary closures and prohibitions of certain activities on public lands in Pershing County, NE, 41108-41111 E8-16373 Management Management and Budget Office NOTICES Federal Family Education Loan Program (FFELP), 41048-41050 E8-16241 Minerals Minerals Management Service NOTICES Outer Continental Shelf, Western Planning Area, Gulf of Mexico, Oil and Gas Lease Sale (207), 41111-41116 E8-16324 Mississippi Mississippi River Commission NOTICES Meetings;
Sunshine Act, 41128-41129 E8-15776 NIH National Institutes of Health NOTICES Meetings: Center for Scientific Review, 41097-41099 E8-15821 E8-16146 E8-16147 E8-16333 National Institute of Allergy and Infectious Diseases, 41100 E8-16143 National Institute of Child Health and Human Development, 41100-41102 E8-16141 E8-16399 E8-16406 National Institute of Diabetes and Digestive and Kidney Diseases, 41101 E8-16405 National Institute of Environmental Health Sciences, 41099 E8-15823 E8-15824 National Institute of General Medical Sciences, 41100 E8-16142 National Institute on Aging, 41099-41101 E8-15825 E8-16336 National Library of Medicine, 41102 E8-16144 NOAA National Oceanic and Atmospheric Administration RULES Fisheries of the Northeastern United States:
Atlantic Mackerel, Squid, and Butterfish Fisheries; closure of the Trimester II Fishery for Loligo Squid, 40986-40987 08-1440 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41040-41041 E8-16310 E8-16311 Availability of Seats for the Florida Keys National Marine Sanctuary Advisory Council, 41041 E8-15778 Availability of Seats for the Stellwagen Bank National Marine Sanctuary Advisory Council, 41041-41042 E8-15779 U.S. Climate Change Science Program Draft Unified Synthesis Product Report:
Global Climate Change in the United States, 41042 E8-16386 National Transportation National Transportation Safety Board NOTICES Meetings; Sunshine Act, 41129 E8-16322 Nuclear Nuclear Regulatory Commission NOTICES Availability of the Final Interim Staff Guidance DC/COL-ISG-05 on the Use of the GALE86 Code for Calculation of Routine Radioactive Releases in Gaseous and, 41129-41130 E8-16364 Confirmatory Order: Mr. Anthony Fortuna, 41130-41131 E8-16365 Environmental Impact Statements;
Availability, etc.: Virginia Electric And Power Company, et al, 41132-41133 E8-16444 Office Office of Management and Budget See Management and Budget Office Personnel Personnel Management Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41133-41134 E8-16257 Postal Postal Service NOTICES Privacy Act; Systems of Records, 41134-41137 E8-16286 E8-16343 Presidential Presidential Documents PROCLAMATIONS *Special observances:* FBI Day (Proc. 8273), 41231-41234 08-1448 Public Public Debt Bureau See Fiscal Service Railroad Railroad Retirement Board NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Correction, 41137 E8-16335 SEC Securities and Exchange Commission NOTICES Meetings: SEC Advisory Committee on Improvements to Financial Reporting, 41138 E8-16351 Self-Regulatory Organizations; Proposed Rule Changes: Boston Stock Exchange, Inc., 41138-41140 E8-16348 Chicago Board Options Exchange, Inc., 41140-41141 E8-16345 International Securities Exchange, LLC, 41142-41143 E8-16363 NASDAQ Stock Market LLC, 41143-41145 E8-16346 New York Stock Exchange LLC, 41145-41147 E8-16349 NYSE Arca, Inc., 41147-41149 E8-16350 Social Social Security Administration RULES Technical Changes to the Title II Regulations, 40965-40967 E8-16332 PROPOSED RULES Technical Revisions to Overpayment Rules, 40997-40999 E8-16330 State State Department NOTICES Bureau of Educational and Cultural Affairs
(ECA)Request for Grant Proposals: Study of the United States Institute on U.S. National Security Policymaking in a Post 9/11 World, 41149-41154 E8-16379 Transportation Transportation Department See Federal Aviation Administration See Federal Highway Administration See Federal Railroad Administration Treasury Treasury Department See Fiscal Service See Internal Revenue Service See United States Mint NOTICES Federal Family Education Loan Program (FFELP), 41048-41050 E8-16241 U.S. Institute of Peace United States Institute of Peace NOTICES Formal Evaluation of the Annual Grant Competition, 41168 E8-15767 U.S. Mint United States Mint NOTICES Meetings: Citizens Coinage Advisory Committee August (2008), 41168 E8-16341 Veterans Veterans Affairs Department NOTICES Meetings: Veterans’ Advisory Committee on Environmental Hazards, 41168 E8-15775 Separate Parts In This Issue Part II Federal Deposit Insurance Corporation, 41170-41211 E8-15492 E8-15493 Part III Transportation Department, Federal Railroad Administration, 41214-41230 E8-16140 Part IV Executive Office of the President, Presidential Documents, 41231-41234 08-1448 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws. To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 73 138 Thursday, July 17, 2008 Rules and Regulations DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Part 390 [FDMS Docket Number FSIS-2005-0028] RIN 0583-AD10 Availability of Lists of Retail Consignees During Meat or Poultry Product Recalls AGENCY: Food Safety and Inspection Service, USDA. ACTION: Final rule. SUMMARY: The Food Safety and Inspection Service
(FSIS)is amending the Federal meat and poultry products inspection regulations to provide that the Agency will make available to the public the names and locations of the retail consignees of meat and poultry products that have been recalled by a federally-inspected meat or poultry establishment if the recalled product has been distributed to the retail level. This rule will apply only where there is a reasonable probability that the use of the recalled product will cause serious adverse health consequences or death (Class I recalls). FSIS will routinely post this information on its Web site as it compiles the information during its recall verification activities. FSIS is taking this action to provide an additional mechanism for prompting consumers to examine products stored in their refrigerator, freezer, or cupboard when there is a reasonable probability that the product will cause adverse health consequences. The retail consignee information will complement the product identification information that FSIS already makes available and will provide additional opportunities for local media outlets and State and local health officials to transmit more targeted information about the recall to consumers. EFFECTIVE DATE: August 18, 2008. FOR FURTHER INFORMATION CONTACT: Philip Derfler, Assistant Administrator, Office of Policy and Program Development, Room 350-E, Jamie L. Whitten Building, 1400 Independence Avenue, SW., Washington, DC 20250; Telephone
(202)720-2709, Fax
(202)720-2025. SUPPLEMENTARY INFORMATION: I. Background FSIS is responsible for ensuring that meat and poultry products are safe, wholesome, and accurately labeled. FSIS enforces the Federal Meat Inspection Act
(FMIA)and the Poultry Products Inspection Act (PPIA). These two statutes require Federal inspection and provide for Federal regulation of meat and poultry products prepared for distribution in commerce for use as human food. When there is reason to believe that meat or poultry products in commerce are adulterated or misbranded, FSIS requests that the establishment that introduced the products into commerce recall them. If the establishment does not agree to recall the products, FSIS has the authority to detain and seize the products. When an establishment recalls products, it is responsible for promptly notifying each of its affected consignees about the recall. In general, the recalling establishment conveys the following information to its affected consignees: • That the product in question is subject to a recall; • That further distribution or use of any remaining product should cease immediately; • Where applicable and required as part of the recall strategy, that the direct consignee should in turn notify its consignees that received the product about the recall; • Instructions regarding what to do with the product; and • Contact information for questions (e.g., a name and toll-free number). Affected consignees carry out instructions provided to them by the recalling establishment and, when necessary, extend the recall to their consignees. FSIS also widely disseminates recall information. For Class I or II recalls, defined in FSIS Directive 8080.1, Revision 4, Recall of Meat and Poultry Products, dated 5/24/04 1 , as those situations where there is a reasonable (Class I) or remote (Class II) probability that the use of the product will cause serious adverse health consequences, FSIS typically issues a press release and distributes recall information to wire services and media outlets in the areas where the product was distributed. FSIS also alerts Congressional delegations and public health partners, such as the Association of Food and Drug Officials, and State departments of health and agriculture, concerning these recalls and posts the recall information on the FSIS Web site. For Class III recalls, defined as those situations where the use of the product will not cause adverse health consequences, FSIS usually does not issue a press release (except in cases of egregious economic adulteration). It distributes a Recall Notification Report
(RNR)to the appropriate Federal, State, and local public health and food inspection agencies and posts it on FSIS' Web site. 1 *http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/8080.1Rev4.pdf* Through press releases and RNRs, FSIS provides the public with pertinent information about the recalled products. To help consumers identify the product, FSIS provides a description of the food being recalled; any identifying codes, including lot numbers, when available; the reason for the recall; the name and official number of the producing establishment; the types of establishments and facilities to which the recall extends; the availability of product at the retail level; FSIS' classification of the recall; pictures of the product or label, when available; and the appropriate contact persons for FSIS and the recalling company. FSIS lists those States to which recalled product was shipped if fewer than 13 States were involved in the recall. If the recall extends to 13 or more States, it is considered a nationwide recall. To date, FSIS has not publicized the names or locations of the retail consignees that received recalled meat or poultry products, although FSIS has on occasion, identified a store or chain if it was the sole retail outlet for the recalled product. During the recall process, FSIS obtains from the recalling establishment the names of the known consignees of the recalled product (based on its records). These consignees may include distributors, warehouses, and retailers. 2 FSIS uses this information to contact all of recalling establishment's affected consignees in order to verify that the establishment has notified all of them of the recall, and that the consignees have removed the recalled products from the market and disposed of them as directed by the recalling establishment. 2 This final rule applies to FSIS-regulated meat and poultry products only. FSIS also compiles lists of all subsequent consignees to which the recalling establishment's direct consignees distributed the recalled product by contacting those consignees to ensure that they were also notified of the recall. The Agency traces the recalled product forward to the retail level. When there is concern that the original distribution information is not accurate or complete, e.g., a generic list of chain stores is missing a few known stores, FSIS will prepare a list identifying the consignees or distributors that may have received the recalled product but were not included in the distribution information provided by the firm. Through this process, as well as that of verifying the effectiveness of the recalling establishment in conducting the recall, FSIS develops a list of consignees, down to and including the retail level, that have, or have had, the recalled products in their possession. FSIS begins its process of verifying the effectiveness of the recalling establishment in conducting the recall, which is described in FSIS Directive 8080.1, as soon as possible within three working days of the initiation of a Class I recall and substantially completes it within 10 working days of the initiation of the recall. On March 7, 2006, FSIS published a proposed rule in the **Federal Register** (71 FR 11326) in which the Agency proposed to post on its Web site the names and locations of the retail consignees of recalled meat and poultry products. FSIS proposed to post this information as the Agency obtained it during its recall verification activities described above. The proposal was developed by FSIS after its evaluation of requests from consumer groups and some State officials, who advocated the public release of information on where recalled meat and poultry products have been shipped or distributed. The State officials requested that this information be provided to them without the limitations imposed by FSIS' regulations, 3 believing that they would be better able to protect the public health with this information. Similarly, some consumer groups asserted that the public could use this information to identify more easily and effectively the product being recalled. These State officials and consumer groups believe that making the retail distribution information available will materially improve the effectiveness of recalls. 3 9 CFR 390.9(a)(1) requires a written statement establishing the State's authority to protect confidential distribution lists from public disclosure and a written commitment not to disclose any information provided by FSIS without the written permission of the submitter of the information or the written confirmation by FSIS that the information no longer has confidential status. FSIS solicited comments on the proposal for thirty days. In addition, on April 24, 2006, FSIS held a public meeting to solicit comments on the proposal. A transcript of that meeting can be found at *http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2006-0009_Transcript.pdf.* Following requests made during the public meeting and written requests submitted during the comment period, FSIS reopened the comment period on May 10, 2007, and solicited comments for an additional 30 days. (71 FR 27211). In response to the proposed rule and public meeting, FSIS received almost 6,000 comments from consumers, consumer advocacy organizations, industry representatives, Federal and State agencies, and professional organizations. This number includes several comments made by individuals at the public meeting and taken from the transcript of that event. There was strong support for the rule from consumers, consumer advocacy organizations, Federal and State agencies, and professional organizations. Collectively, these individuals and groups filed 26 comments supporting the rule. The remainder of the comments supporting the rule were form letters. FSIS received nine comments from industry representatives opposed to the proposed rule. These comments expressed generally similar objections to the rule. After carefully evaluating the comments, FSIS has decided to adopt the proposed rule with modifications. Specifically, the Agency has decided to limit the application of this final rule to Class I recalls, that is, recalls where the Agency has determined that there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. FSIS proposed applying the rule to all classes of recalls. However, after evaluating the comments, including those that suggested that it is not necessary to make publicly available retail consignee lists in situations where food safety concerns are minimal, FSIS has concluded that it is prudent to modify the rule to apply only to those recalls involving products where there is a reasonable probability that the use of the recalled product will cause serious adverse health consequences or death. In addition, this final rule makes clear that FSIS will make available the names and locations of all retail consignees of recalled meat or poultry products that the Agency compiles in connection with a Class I recall. The list will not be limited to those consignees that are actually the subject of FSIS recall effectiveness checks, which was how some commenters interpreted the proposed rule. Finally, FSIS simplified and removed unnecessary text from the codified language. II. Response to Comments Some commenters asserted that knowing the names of retail consignees would help members of the public make better informed decisions in responding to recalls. Other commenters stated that providing retailer names and locations would enhance the usefulness to consumers of the information that FSIS already provides, such as the States in which product was distributed, because consumers would be more likely to check the meat and poultry products in their possession if they regularly shop at a store that sold the product involved in a recall. Therefore, these commenters believed that the overall effectiveness of recalls would be increased. Some commenters stated that the information currently provided by FSIS may not be sufficient because consumers may not know where to look for product codes or establishment numbers; others stated that this rule change is a common sense solution that will help consumers to identify recalled products if they have them in their possession and thus better protect themselves from adulterated or misbranded products. The Agency believes that its current recall system has been effective, but when there is a reasonable probability that the product will cause adverse consequences, it would be useful to provide an additional mechanism for prompting consumers to examine products stored in their refrigerator, freezer, or cupboard. The retail consignee information will complement the product identification information that FSIS already makes available and will provide additional opportunities for local media outlets and State and local health officials to transmit more targeted information about the recall to consumers. If the name of a store where a consumer shops appears on the posted list of consignees, it will very likely prompt the consumer to use product-specific information to determine whether recalled product is one he or she may have purchased and stored. If the consumer in fact has the recalled product, he or she can take appropriate action to either dispose of the product or return it to the retailer and not consume it. As noted by the commenters who supported this rule change, the retail consignee information should be particularly helpful in recalls involving products where the product identification information is limited, such as non-branded product and meat and poultry products that are packaged at the retail level. Products packaged at the retail store usually do not bear the establishment number of the official establishment that is recalling the product. Some commenters favoring the rule suggested that FSIS list the retail consignees in the press release because some people may not own a computer or know how to find the information on the FSIS Web site. In most cases, FSIS will not have information on retail consignees available at the time the press release is issued, which generally occurs before the recall verification activities begin. Of course, FSIS will continue to provide in its press release the same important information about the recalled products currently made available, including a description of the food being recalled; any identifying codes, including lot numbers, when available; the name and official number of the producing establishment; the types of establishments and facilities to which the recall extends; the availability of product at the retail level; FSIS' classification of the recall; pictures of the product or label, when available; and the appropriate contact persons for FSIS and the recalling company in the press release. FSIS intends to release the information regarding retail consignees of products subject to a Class I recall as soon as possible during the course of the recall. Generally, for Class I recalls, this information should be available within three to 10 working days. One commenter generally concurred with the proposal but suggested that FSIS clarify the rule to explain that the posted information is incomplete because only those retail locations selected by the Agency in conducting recall effectiveness checks would be identified. The commenter misunderstood the Agency's proposal. FSIS intends to post the names and locations of all known retail consignees identified as having received meat or poultry products subject to a Class I recall, irrespective of whether the Agency conducted a recall effectiveness check at that location. FSIS has modified 9 CFR 390.10 to make this clear. Several commenters supported the proposed rule but stated that it did not go far enough. In addition to identifying the retail consignees, they believe that FSIS should also make available the names of intermediate consignees, including hotels, restaurants, food service institutions, and intermediate distributors. Intermediate consignees may receive product directly from the manufacturer or from a distributor at the wholesale level. Intermediate consignees prepare their products for immediate, on-site consumption, not for delayed consumer preparation at home. Several commenters supporting the rule believe that limiting distribution information to retail consignees will create an unnecessary hurdle for State or local public health agencies to overcome to obtain timely distribution information. One commenter stated that providing this information for food service establishments would “provide consumers greater protection from the risks associated with tainted meat or poultry,” while another suggested that restaurants be included so that individuals are fully aware of the scope of recalls. FSIS is making no changes based on these comments, which are outside the scope of this rulemaking. The Agency is taking this action to provide an additional mechanism for prompting consumers to examine products stored in their refrigerators, freezers, or cupboards when there is a reasonable probability that the product will cause adverse health consequences so that they can take appropriate action to either dispose of the product or return it to the retail store at which it was purchased. Making available the names of intermediate consignees will not advance the purposes of this rulemaking because there is no reason to believe that this information will help consumers to determine that they have the recalled products in their possession. Further, FSIS does not agree that publicly identifying food service establishments would provide consumers greater protection from the risks associated with tainted meat or poultry. To ensure that Class I recalled products held by intermediate consignees do not reach consumers, intermediate consignees that have recalled products in their possession are obligated to segregate them from all other non-recalled products and dispose of them as directed by the recalling establishment. This is also true of recalled products held by retail consignees. In addition, FSIS already has in place a process to share distribution information, including the names and addresses of intermediate consignees, with State and local public health agencies to ensure that intermediate consignees have disposed of the recalled product. 4 4 *See* 9 CFR 390.9. Several commenters opposed to the rule stated that adoption of the proposal would hamper the currently effective recall procedures and adversely affect public health. These commenters stated that providing consumers with the names of retail consignees will hamper recall efficiency because this information may be inaccurate, leading to increased returns of product that has not been recalled. One commenter stated that the lists of retail consignees will be untimely and may lead to consumer apathy and failure to heed recall notices. A few commenters stated that consumers have all the information they need to identify recalled product, and that they do not require retail store information to identify implicated product. FSIS disagrees that publishing the names of retail consignees will diminish the effectiveness of the Agency's recall procedures, hamper identification of recalled product, or result in the release of untimely or inaccurate information. As they currently do, the FSIS verification procedures will ensure that any inaccuracies in the retail consignee list are identified and corrected quickly. FSIS has determined that starting to post the names and locations of retail consignees within three working days of the initiation of a Class I recall will make its lists timely. FSIS does not believe consumers will ignore the product specific information that the Agency currently provides to assist them in accurately identifying the recalled product. Rather, retail consignee information will complement the product identification information that FSIS already makes available and will provide additional opportunities for local media outlets and State and local health officials to transmit more targeted information about the recall to consumers. Further, FSIS notes that in some recalls, product specific information is limited. Some products do not bear product codes or establishment numbers. They are packaged at the retail level and thus have limited identification. In 2007, almost 9 percent of the recalled meat and poultry products sold at retail stores were non-branded. Providing the names and locations of retail consignees, in conjunction with the other information provided, in these cases, will be particularly important for prompt identification. In addition, for a variety of reasons, consumers may remove product from the original packaging and store it in containers that lack the identification information. In these situations, publishing only the establishment number, product codes, and States where the product was distributed is of little use to the consumer. However, identifying the retail store at which the product was available for sale by name and location provides consumers with additional information that will trigger efforts on their part to determine whether they purchased the recalled product. FSIS is providing this information on the retail consignees of a Class I recalled product so that consumers can use it in conjunction with the information the Agency already provides to identify the recalled products and to act appropriately with respect to those that have actually been recalled. Returning recalled products to the store at which they were purchased is just one option consumers have. Consumers may also dispose of such products at home. The objective of the rule is to provide an additional mechanism for prompting consumers to examine products stored in their refrigerator, freezer, or cupboard when there is a reasonable probability that the product will cause adverse health consequences. The retail consignee information will complement the product identification information that FSIS already makes available and will provide additional opportunities for local media outlets and State and local health officials to transmit more targeted information about the recall to consumers. In response to commenters and to ensure that consumers do not misunderstand the retail consignee list, FSIS will provide the following explanatory statement that will accompany the list that will make it clear that the list is still under development: FSIS has reason to believe that the following retail locations received [describe meat or poultry products that are subject of recall] that has been recalled by [name of company]. This list may be incomplete. Please use the product-specific identification information, which is available at [insert link to specific recall] to check meat or poultry products in your possession to see if they have been recalled. FSIS continues its investigation in conjunction with this recall and will update this list, as appropriate. Significantly, the statement gives the Agency an opportunity to urge people to consult the identifying information about the product. Some of the commenters opposed the rule because they believed that the provision of incomplete lists of retailers by FSIS could weaken public health protection by providing consumers a false sense of security. These commenters felt that incomplete lists, even if accompanied by an appropriate explanation, would not be helpful. Consumers might assume that product from unlisted stores was safe to eat, and they would not check the product information provided in the Agency's press release in addition to the store information. Other commenters believed that incomplete lists would force consumers to return repeatedly to FSIS' Web site. An explanatory statement, in itself, they stated, indicates that consumers should not place confidence in the list when deciding what to do about recalled products. On the other hand, commenters favoring the proposal said that some information is better then none, and that FSIS should post the retail consignee information, even if incomplete, along with an appropriate explanation stating that, for example, the posting consists of retail consignees known to date. FSIS has concluded that the retail consignee information will effectively complement the product information currently made available and will be helpful to consumers in responding to the recall. While there is always some slight potential for misinterpretation of the retail consignee information, FSIS has also concluded that an appropriate explanatory statement will minimize any such potential. As discussed previously, FSIS will post an explanatory statement on its Web site, along with the retail consignee information. The Agency also thinks that local media outlets, including television stations and newspapers, will publicize the names and locations of new retail consignees as they are posted on FSIS' Web site. FSIS will also notify relevant State officials if retail stores in their states are identified as having received recalled product. One commenter suggested that, as an alternative to this rulemaking, the Agency might consider providing additional consumer education materials that would encourage consumers to focus on available product identification information. While FSIS agrees that improvements in consumer education might encourage consumers to focus on available product identification information, improving consumer education alone will not achieve the goals of this rule. As stated previously, the retail consignee information will complement the product identification information that FSIS already makes available and will provide additional opportunities for local media outlets and State and local health officials to transmit more targeted information about the recall to consumers. FSIS will certainly explore additional ways to improve communication and consumer education concerning recalls and hopes to work with industry, consumer groups, and other stakeholders to achieve this end. FSIS' goal in a recall is to provide the important information that allows consumers to identify recalled product and to determine whether that product is in their possession as effectively and quickly as possible. FSIS has already taken several steps to assist consumers in identifying recalled product. FSIS agrees with the commenter, for example, that information about the frequent availability of photos of the recalled product labels on the FSIS Web site should be promoted. That is why each Agency press release or other information on the FSIS Web site already includes photographs of the recalled products' labels, if available. A fact sheet on recalls, which can be found on the Agency's Web site at *http://www.fsis.usda.gov/Fact_Sheets/FSIS_Food_Recalls/index.asp* , also informs readers that FSIS includes pictures of the recalled product as part of the online recall press release. Each press release or RNR also informs consumers that the label bears the establishment number inside the USDA seal of inspection and provides the timeframe during which the recalled product was produced, another piece of information that the commenter believes consumers would find useful. Some industry commenters opposing the proposal stated that retail consignee information is protected from mandatory public disclosure by exemption 4 of the FOIA because it is confidential business or commercial information, and the potential value of this information would not outweigh the competitive harm that would be caused by its release. They pointed out that FSIS has traditionally treated a company's distribution list as confidential business information. 5 5 *See* “Sharing Recall Distribution Lists With State and Other Federal Government Agencies,” (67 FR 20009; April 24, 2002). The FOIA generally requires that agencies disclose records unless the records fall within one of the FOIA exemptions from disclosure, such as the exemption for trade secrets and commercial or financial information found in 5 U.S.C. 552(b)(4). In this situation, an agency must analyze whether the information constitutes privileged or confidential commercial information within the meaning of 5 U.S.C. 552(b)(4). FSIS, however, in considering the application of Exemption 4, has determined that the names and locations of retail consignees of recalled meat and poultry products compiled by the Agency do not constitute confidential commercial information because the disclosure of this information will not impair the Agency's ability to obtain necessary information in the future and will not cause substantial harm to the competitive position of any business. As noted in the proposed rule in this proceeding, FSIS is not releasing a firm's distribution list to the public. The Agency is also not posting the names and locations of any of the intermediate consignees that received recalled product or that routinely receive product from that firm. Rather, FSIS is making public a list that FSIS personnel compile of only the retail consignees that received recalled product. This would be true even in those rare instances in which the list of retail consignees includes all of the recalling establishment's customers. Because of the complex food distribution system in the United States, which can include multiple wholesalers or other intermediate distributors, it is quite possible, and perhaps likely, that the retail consignees that ultimately sell the product to the consumer are not customers of the federal establishment that produced the product. Therefore, only very rarely, if ever, will the names and locations of retail consignees expose a recalling establishment's entire customer or distribution list. Even in such circumstances, the establishment's customer list will not be identified as such. As a result, members of the public and industry will not be able to determine what significance the list has for the recalling establishment. The disclosure of the names and locations of retail consignees of recalled meat and poultry products compiled by the Agency is not likely to impair FSIS's ability to obtain the names of consignees that have received recalled product. Under the FMIA, PPIA, and the implementing regulations that FSIS has adopted under those Acts, persons engaged in the business of buying, selling, or transporting meat and poultry products are required to give representatives of FSIS access to their records. 6 Among the records that are required to be kept are those that provide a description of the articles sold, including the net weight of the articles, the name and address of the buyer of the articles sold by the person, and the name and address of the consignee or receiver, if other than the buyer. 7 Because retail consignees that have received recalled meat and poultry products are engaged in the business of buying (and selling) meat and poultry products, they must keep various required records associated with those products, and they must make them available to FSIS. As such, FSIS's disclosure of those retail consignee names is not likely to impair the Agency's ability to obtain the names of such consignees in the future. 6 21 U.S.C. 642(a), 460(b) and 9 CFR 320.1(a), 320.4, 381.175(a), 381.178 7 9 CFR 320.1(b), 381.175(b). FSIS has also determined that disclosing the names and locations of retail consignees that have received meat and poultry products that are the subject of a Class I recall will not cause substantial harm to any business. Companies have a general, affirmative interest in letting consumers know where product is available for purchase, and they make this information known in various ways, including company Web sites and advertising. Thus, where the product that is the subject of a Class I recall is branded, the company will suffer no substantial harm from the release of retail consignee names and locations. Even when unbranded product is the subject of a Class I recall, there will not be substantial competitive harm from release of the consignee list. First, the fact that the company that produced the unbranded product is experiencing a recall is known. It is disclosed by the Agency's press release. Second, in this situation, the name of a supplier of unbranded product (e.g., ground beef) is of minimal to no commercial value. Furthermore, information as to the type of product sold in the store is readily available from its advertising or from visiting the store. Finally, there is no reason to believe that the retailer would suffer substantial harm to its competitive position from the release of its name. Many retailers post notices of recalls in their stores, and some take affirmative steps to notify consumers of recalls by, for example, contacting holders of customer loyalty cards who purchased the product. This behavior is simply inconsistent with a claim of harm. For all of these reasons, the Agency has determined that the retail consignee information does not constitute confidential commercial information. FSIS does not intend to change how it compiles its lists of the consignees to whom recalled products have been distributed as a result of this rule, nor does it anticipate that recalling establishments will do so either. FSIS routinely compiles consignee information when a recall occurs, and it expects that recalling firms will continue to make available to the Agency information on the firms to which it has shipped the recalled products, consistent with regulatory and statutory requirements. Some commenters stated that the proposal may force firms recalling product out of business because those firms' competitors will take their retail customers during a vulnerable time period. These commenters also stated that the rule will damage the relationship between processors and their customers, allowing competitors to take advantage of the situation. FSIS disagrees. The situation described by the commenters already arises whenever there is a meat or poultry recall. When there is a recall, retail consignees seek to replace the recalled product as quickly as possible. To do so, they may turn to their regular supplier's competitor for a similar product, or they may ask their supplier to replace the recalled product. Whether the processor-retail consignee relationship is impaired by a recall is a function of the nature, scope, and circumstances of the recall, not of the disclosure of the consignee list. FSIS recognizes that a retail consignee may be solicited by a new supplier attempting to use a recall as a basis for gaining new customers, and that the supplier may identify the consignee from the posted list. No evidence has been presented in this rulemaking proceeding, however, that the availability of a list of recall consignees will significantly enhance the effect of those efforts. In fact, through the years, many retail stores have made clear that they sold product that was the subject of a recall through signs, placards, and contacts with holders of bonus or club cards. Through these steps, these retail stores have made clear to the public that they carried the recalled product and thus they made themselves readily identifiable to competitors of the recalling firm. Accordingly, the Agency has concluded that there is no basis upon which to conclude that any substantial harm will result. A few commenters expressed concern that public interest groups may use the retail consignee lists to encourage their members to harass or boycott businesses involved in a recall and not to improve consumer awareness of recalls. These commenters expressed concern that such use could result in damage to the reputation of an establishment or its customers. As discussed above, many retail stores have notified their customers and the public when they have sold recalled meat and poultry products. Nonetheless, the commenters raising this concern did not cite specific occurrences of retailer harassment or boycotts due to the self-release of retailer names, nor is the Agency aware of any situation where this information has been misused in the way suggested by the commenters. One commenter suggested that distributing the names and locations of retail consignees to the public is not necessary for the proper performance of the functions of the Agency and suggested that the proposed rule was inconsistent with the Paperwork Reduction Act. FSIS disagrees. This rule imposes no new information collection requirements on the regulated industry. Under this final rule, FSIS will continue to compile the names and locations of retail consignees that have received recalled meat and poultry products. The only change is that FSIS will be making this list public. As previously noted, FSIS already requires federally-inspected establishments and companies that engage in the business of buying or selling meat or poultry products to maintain records that will fully and correctly disclose all transactions involved in their businesses subject to the FMIA and PPIA. 8 These entities must also allow representatives of the Secretary of Agriculture access to their places of business so that they can examine and copy all the records. 9 8 21 U.S.C. 642(a), 460(b) and 9 CFR 320.1, 381.175. 9 21 U.S.C. 642(a), 460(b) and 9 CFR 320.4, 381.178. FSIS routinely compiles information contained in these records in carrying out its existing recall procedures. 10 FSIS is not requiring companies to submit any new or different information to the Agency as a result of this rule. The burden remains on FSIS to compile and distribute the information. 10 OMB control number 0583-0015. Furthermore, sections 677 of the FMIA and 467d of the PPIA provide that section 9 of the Federal Trade Commission Act
(FTCA)(15 U.S.C. 49) is applicable to the administration and enforcement of the FMIA and the PPIA. Under Section 9, duly authorized agents of the Secretary have, at all reasonable times, access to, for the purpose of examination, and the right to copy, any documentary evidence of any person, partnership, or corporation being investigated or proceeded against. A few commenters stated that the proposal is not in conformity with the Data Quality Act
(DQA)because the data will not be compiled by FSIS in a timely fashion and is not of sufficient quality because it could be inaccurate. FSIS disagrees with these commenters and has determined that this rule fully complies with applicable requirements of the DQA and relevant guidelines issued thereunder. Under this rule, accurate, objective information will be disseminated to the public that will be useful in helping consumers to determine if they possess recalled meat and poultry products. USDA's Information Quality Activities Regulatory Guidelines require that the information disseminated by USDA agencies and offices in conjunction with their rulemaking activities be reasonably reliable and reasonably timely. From direct contacts with the producer and distributors of the recalled product, FSIS compiles a list of retail consignees that have received recalled meat and poultry products, generally within 10 days of the initiation of the recall. It is from these contacts that the Agency will compile, and then post on its Web site, the listing of retail consignees that have received meat and poultry products subject to a Class I recall. Because the contacts with the producer and distributors are direct, FSIS has determined that the lists of retail consignees are reliable. FSIS is committed to posting the information in a timely fashion. Executive Order 12866 and Regulatory Flexibility Act This rule was reviewed by the Office of Management and Budget under Executive Order 12866 and was determined to be significant. FSIS, after reviewing public comments to the proposed rule, concluded that further analysis of the costs and benefits of the rule, and a regulatory flexibility analysis was warranted. The Agency analyzed the potential impact of the final rule on small meat and poultry establishments and small retail firms as part of this Final Regulatory Flexibility Analysis. The Final Regulatory Flexibility Analysis data is included in this final regulatory impact analysis
(FRIA)and is presented below. This FRIA differs from the preliminary regulatory impact analysis
(PRIA)that was published for the proposed rule. First, the FRIA now focuses only on Class I recalls. Even though this does not significantly affect the impact analysis, FSIS has concluded that it is prudent to modify the rule to apply only to those recalls involving products that present the greatest risk to public health. Second, more of the analytic information is provided so that the public can better understand the number of recalling establishments and retailers that are affected. A. Need for the Rule FSIS is taking this action to provide an additional mechanism for prompting consumers to examine products stored in their refrigerator, freezer, or cupboard when there is reasonable probability that the product will cause adverse health consequences. The retail consignee information will complement the product identification information that FSIS already makes available and may provide additional opportunities for local media outlets and State and local health officials to transmit more targeted information about the recall to consumers. B. Baseline The baseline provides a set of conditions against which the costs and benefits of the rule can be measured. It is important to note that the baseline for this rulemaking takes into account that, in some cases, Class I recalled products have not reached the retail level at the time the recall is initiated. 1. Recall Procedures Once an establishment agrees to recall adulterated or misbranded meat or poultry products, FSIS widely disseminates information about the recalled product to the public. For Class I recalls, FSIS issues a press release to media outlets. The press release lists the names of the states to which recalled product was shipped, if less than 13 states are affected. If the recall extends to 13 or more states, it is considered to be a nationwide recall, and FSIS does not list the names of the states to which the recalled product was shipped. FSIS sends recall information to wire services and media services in the areas where the product was distributed. In addition, FSIS sends recall information to several media and constituent list-servers. The Agency also informs or works with affected State and local public health officials to identify recalled products. These State and local public health officials then further publicize the information about the recalled products. The only change in the recall process brought about by this rule is that FSIS will make available to the public the names and locations of retail consignees of meat and poultry products subject to a Class I recall, as they are identified by FSIS inspection program personnel. 2. Total Number and Size of Recalls The total number of Class I recalls and the amount of product for all classes recalled for 2000-2007 are shown in Table 1. The last column shows that the majority of recalls are Class I recalls (ranging from 63.5% to 99.9% of total recalled products), although the number and the volume of Class 1 recalls varied from year to year. Table 1.—Number of Class I Recalls and Volume of Class I and Total Recalls (in Pounds) Year of recalls Number of class I recalls Volume class I recalls Total volume of all classes (I, II, and III) recalls Class I as a percent of total recalls 2000 65 21,099,672 22,743,092 92.8 2001 61 21,230,301 33,410,564 63.5 2002 81 56,415,558 58,911,071 95.8 2003 45 2,288,040 3,503,689 67.0 2004 40 2,454,558 2,882,018 85.4 2005 48 5,940,089 6,446,149 92.5 2006 26 4,785,669 5,947,933 80.5 2007 50 142,885,981 143,063,822 99.9 Source: FSIS, Recall Management Staff, March 2008. Historical recall information is available at: *www.fsis.usda.gov* . 3. Amount of Product Recovered While the majority of recalls in the past eight years (2000-2007) were Class I recalls, the recovery rate of Class I recalled products was relatively low in six out of the eight years. The average annual percentage of product recovered from a Class I recall was only 27.7 percent (Table 2). Table 2.—Number of Food Product Class I Recalls: Amount Recalled, and Recovered Year Volume of recalls (in million lbs.) Volume recovered (in million lbs.) Percentage recovered 2000 21.1 3.37 16.0 2001 21.23 4.46 21.0 2002 56.42 9.20 16.3 2003 2.29 0.49 20.6 2004 2.45 1.43 58.4 2005 5.94 4.46 74.4 2006 4.79 0.66 13.8 2007 142.89 1.65 1.2 Source: FSIS, Recall Management Staff, March 2008. 4. Number of Retail Consignees Retail consignees are defined as establishments that receive product directly from a federally-inspected meat or poultry establishment or through an intermediary, i.e., distributor or wholesaler, also called an intermediate consignee. A retail consignee sells product received in this manner to the final consumer. Distributors or institutions that do not sell product directly to the general public are not retail consignees. Restaurants are not retail consignees. The number and type of retail consignees potentially affected by the final rule are shown in Table 3. This is a total of about 73,215 retail firms. The retail trade sector comprises facilities engaged in retailing merchandise, generally without transformation, and rendering services incidental to the sale of merchandise (U.S. Census Bureau, 2002 *Economic Census: Retail Trade* ). Retailing is the final step in the distribution of merchandise. Table 3.—Retail Firms Handling Product Primarily Subject to Recall NAICS code Kind of business Number of firms 1 Number of small firms 2 44511 Supermarket and other grocery (except convenience) stores 42,318 34,638 44512 Convenience stores 25,527 25,410 44521 Meat markets 5,354 5,024 45291 Warehouses and Supercenters 16 3 Total 3 73,215 65,075 1 Source: U.S. Census Bureau, 2002 *Economic Census: Retail Trade* . Establishment and Firm Size EC02-4455-52. November 2005. 2 Small Business Administration, Office of Advocacy. Comment to FSIS Docket Clerk, May 4, 2006 regarding Docket No. 04-006P. Firms comprised of supermarkets, convenience stores, and warehouse clubs are defined as small if annual sales are less than $25 million; meat markets are small if sales are less that $6.5 million. 3 This is an undercount of the number of retail firms that would be subject to recalls because there are firms that are primarily fueling stations or drug stores that sell relatively small quantities of milk, bread, convenience foods, and packaged lunch meat that are not counted by the U.S. Census Bureau. The kinds of businesses identified as potentially subject to the final regulation are: • 44511—Supermarkets and other grocery (except convenience) stores. These facilities sell a general line of food. • 44512—Convenience stores. This industry comprises facilities known as convenience stores or food marts (except those with fuel pumps) primarily engaged in retailing a limited line of goods that generally includes milk, bread, convenience foods, soda, and snacks. • 445210—Meat markets. These facilities are engaged in retailing fresh, frozen, or cured meats. • 452910—Warehouse clubs and supercenters. This industry is comprised of facilities known as warehouse clubs, superstores, or supercenters primarily engaged in retailing a general line of groceries in combination with general lines of new merchandise, such as apparel, furniture, and appliances. • In addition, there are a number of retail firms that would be subject to recalls because, while these firms primarily sell fuel or drug stores items, a small fraction of their sales represent milk, bread, convenience foods, and packaged lunch meat. Most, if not all supermarkets, convenience stores, meat markets, and warehouse clubs sell product from federally-inspected establishments and derive a significant share of revenue from those products. While fueling stations and drug stores sell product from federally-inspected establishments, they derive an insignificant share of revenue from those products. If Class I recalled products from federally-inspected establishments were to be sold by these fueling stations and drug stores, then their names and locations would be made publicly available by FSIS during the relevant recall investigation since they would be considered retail consignees that have received Class I recalled meat and poultry products. C. Description of Alternatives FSIS considered several options, including amending its regulations to include local health departments as entities that could receive recall distribution lists or making the lists available only in response to Freedom of Information requests and to State agencies with agreements under 9 CFR 390.9. In addition, FSIS considered further education of consumers, but FSIS already has education programs and information on its Web site to inform consumers about how to identify recalled meat and poultry products. FSIS also considered making available to the public the names and locations of retail consignees of both Class I and Class II recalls. However, FSIS chose to limit the requirements of the final rule to Class I meat and poultry recalls because Class I recalls are reasonably likely to affect the public health, while Class II recalls are only remotely likely to affect the public health. Furthermore, most (64 to 99.9 percent) of the recalled products were Class I recalls (see Table 1). FSIS has adopted an approach that will alert individual consumers, State and local authorities, and other Federal agencies of the names of retail stores in which the Class I recalled products may be found in as expeditious a manner as possible. D. Analysis of Cost For this rule, the cost impacts for meat and poultry processors and retail consignees are expected to be minimal. 1. Impact on Meat and Poultry Processors This action will not impose additional significant monetary cost on processing establishments conducting a Class I recall. FSIS acknowledges that some products might be incorrectly returned because they are similar to what is being recalled and are sold by the listed retailer. However, the Agency is aware that consumers already return products incorrectly (i.e., products not subject to recall) without knowing the retailers associated with the recalled products. Whether the incorrectly returned products would increase or decrease with the implementation of this rule is an empirical question. The Agency does anticipate that the volume of correctly returned products will increase as this rule is intended to enhance the effectiveness of recalls. 2. Impacts on Retail Outlets The effects of this rule on the product and financial markets for retail facilities that receive Class I recalled product are likely to be even less pronounced than those for the processing firms that produce the adulterated or mislabeled product. Already, some retail facilities, such as Wegman's, notify customers about Class I recalled meat and poultry products. Some costs may accrue for retail consignees as a result of increased product handling and disposal. As mentioned before, it is not certain whether the incorrectly returned products and the associated costs will increase or decrease as a result of this rule. E. Analysis of Benefits If consumers use retail consignee information and are prompted to identify and return Class I recalled meat and poultry products, the recall process will be more timely and effective. Nonetheless, the Agency acknowledges that it is difficult, if not impossible to quantify, ex ante, the potential benefits, as one cannot predict what kind and how many recalls will take place in the future. 1. Increased Opportunity to Target Information to Consumers Information about the safety of food will cause consumers to respond if there is a clear and relevant message, actions are advocated that consumers can understand and accomplish, and there are continued reminders. If consumers have access to recall information that is meaningful, recall recovery rates can be expected to increase for Class I recalls, given the level of risk. 11 11 The rate of recovery of recalled product could be affected by other factors, however. The share of products affected by Class I recalls that are raw or ground is likely higher than that for other recall classes. Consequently, the product may move quickly through distribution and retail channels than processed or RTE products. The current recall system will be augmented by providing targeted information to consumers about the retail destinations of products subject to a Class I recall. The potential value of the Class I recall information depends on the consumer's ability to remember recent purchases of meat and poultry products and the ability of the information to trigger in the consumer the behavior to check whether he or she purchased the recalled product. Consumers may be prompted to take action if they are informed that the product was sold at the retail location where they purchase groceries for themselves and their families. The retail consignee information will effectively complement the product identification information that FSIS already makes available and will provide additional opportunities for local media outlets and State and local health officials to transmit more targeted information about the recall to consumers. 2. Effectiveness of Recalls The amount of product recovered during a recall depends on many factors. Among these factors are the amount of time taken to alert the public after the adulterated product has been identified, the time required by FSIS to perform recall verification activities, the type of product being recalled (some products are consumed within days of distribution), the amount of time the product is in distribution and retail channels, the efficiency of recalling establishment's recall management system, the depth into the distribution system the recall management system operates, the number of distributors through which the recalled product has moved, and the responsiveness of consumers to Class I recall information. As mentioned above, the objective of this rule is to improve the current recall system by providing targeted information to consumers about the retail destinations of products subject to a Class I recall. FSIS believes this rule will have an impact on recall effectiveness primarily through consumer responsiveness. FSIS also believes that making information concerning retail destinations available to the public may also influence the firms' efforts to recall their products; however, it is difficult to predict all of the variables that could be affected, given the differences among the various distribution channels for meat and poultry products. Because this rule provides an additional mechanism for prompting consumers to examine products, FSIS has determined that posting the list of retail consignees will enhance the effectiveness of Class I recalls. F. Net Benefits There is no evidence to suggest that the impacts on retail establishments would be significant because Class I recalled products are typically credited to the affected retail establishment by the processing establishment that manufactured the product. The potential benefits of the rule hinge on the consumer being able to use the retail consignee information in combination with the information currently provided to identify product more quickly and effectively than he or she does currently, so that more illnesses and deaths can be avoided. Based on these factors, the Agency has determined that the expected benefits of the proposal exceed potential costs. Final Regulatory Flexibility Analysis The Agency analyzed the potential impact of the final rule on small entity meat and poultry establishments and small entity retail firms that receive product subject to a Class I recall. The Agency's analysis of the adverse impacts of the rule on small retail firms focuses on the increased amount of product returns retail stores would receive in response to a Class I recall, even product that is not subject to the recall. The number and type of small entity retail consignees potentially affected by the final rule is shown in Table 3. This is a total of about 65,075 small retail firms. Some costs may accrue as a result of increased product handling and disposal. But as mentioned above, it is not certain whether incorrectly returned products and their associated costs will increase or decrease as a result of this rule. Based on the above analysis, the Agency has concluded that the rule will not have a significant economic impact on a substantial number of small entities. References 1. Buzby, Jean, Paul D. Frenzen, and Barbara Rasco. 2001. “Product Liability and Microbial Foodborne Illnesses,” AER-799, USDA, Economic Research Service, Washington, DC. 2. RTI, International. June 2005. *Survey of Meat and Poultry Slaughter and Processing Plants. Final Report.* RTI Project Number 08893.007. Research Triangle Park, NC 27709. 3. RTI, International. April 2006. *Survey of Meat and Poultry Processing Only Plants. Final Report.* RTI Project Number 0208893.016. Research Triangle Park, NC 27709. 4. U.S. Census Bureau. 1997 Economic Census, Retail Trade. EC97R455-SM. Issued January 2001. *http://www.census.gov/prod/ec97/97r44-sm.pdf* . Paperwork Requirements No new paperwork requirements are associated with this final rule. FSIS is making available to the public on its Web site the names and locations of the retail consignees of recalled meat or poultry products that the Agency compiles in connection with its recall verification activities. Executive Order 12988 This rule has been reviewed under Executive Order 12988, Civil Justice Reform. When this final rule is adopted:
(1)All state and local laws and regulations that are inconsistent with this rule will be preempted;
(2)no retroactive effect will be given to this rule; and
(3)administrative proceedings will not be required before parties may file suit in court challenging this rule. E-Government Act Compliance The Food Safety and Inspection Service is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. Additional Public Notification Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that minorities, women, and persons with disabilities are aware of this notice, FSIS will announce it online through the FSIS Web page located at *http://www.fsis.usda.gov/regulations/2008_Final Rules_Index/* . FSIS will also make copies of this **Federal Register** publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, **Federal Register** notices, FSIS public meetings, and other types of information that could affect or would be of interest to constituents and stakeholders. The Update is communicated via Listserv, a free electronic mail subscription service for industry, trade groups, consumer interest groups, health professionals, and other individuals who have asked to be included. The Update is also available on the FSIS Web page. Through the Listserv and Web page, FSIS is able to provide information to a much broader and more diverse audience. In addition, FSIS offers an e-mail subscription service that provides automatic and customized access to selected food safety news and information. This service is available at *http://www.fsis.usda.gov/news_and_events/email_subscription/* . Options range from recalls to export information to regulations, directives and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts. List of Subjects in 9 CFR Part 390 Public information. For the reasons discussed in the preamble, FSIS is amending 9 CFR Chapter III, Subchapter D, as follows: PART 390—FREEDOM OF INFORMATION AND PUBLIC INFORMATION 1. The authority citation for part 390 is revised to read as follows: Authority: 5 U.S.C. 301, 552; 21 U.S.C. 451-471, 601-695; 7 CFR 1.3, 2.7. 2. A new § 390.10 is added to read as follows: § 390.10 Availability of Lists of Retail Consignees during Meat or Poultry Product Recalls. The Administrator of the Food Safety and Inspection Service will make publicly available the names and locations of retail consignees of recalled meat or poultry products that the Agency compiles in connection with a recall where there is a reasonable probability that the use of the product could cause serious adverse health consequences or death. Done in Washington, DC, July 11, 2008. Alfred V. Almanza, Administrator. [FR Doc. E8-16221 Filed 7-16-08; 8:45 am] BILLING CODE 3410-DM-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0639; Directorate Identifier 2007-NM-003-AD; Amendment 39-15564; AD 2008-13-01] RIN 2120-AA64 Airworthiness Directives; Fokker Model F27 Mark 050 Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule; request for comments. SUMMARY: We are adopting a new airworthiness directive
(AD)for the products listed above. This AD results from mandatory continuing airworthiness information
(MCAI)originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: During scheduled X-ray inspections of Fokker 50 (F27 Mark 050) engine mounting frames, welding defects were discovered. In two forward frames and one aft frame, defects were found in a total of 4 weld locations. Investigation showed that during manufacture of the frames, when the tubes were welded to the end fittings, unintentional sideways movement of the electric arc resulted in some welds running beside the borderline for a part of the tube circumference. Where a weld runs beside the borderline, there is no connection between tube and end fitting for that part of the circumference, directly affecting the structural integrity of the engine mounting frame connections. The defective welding process appears to have happened at some of the welds in an unknown number of engine mounting frames. This condition, if not corrected, could lead to failure of the engine mounting frame in cases where multiple welds are severely affected, potentially resulting in in-flight loss of an engine. * * * This AD requires actions that are intended to address the unsafe condition described in the MCAI. DATES: This AD becomes effective August 1, 2008. The Director of the Federal Register approved the incorporation by reference of certain publications listed in the AD as of August 1, 2008. We must receive comments on this AD by August 18, 2008. ADDRESSES: You may send comments by any of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov* . Follow the instructions for submitting comments. • *Fax:*
(202)493-2251. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Hand Delivery:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.gov;* or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone
(800)647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)227-1137; fax
(425)227-1149. SUPPLEMENTARY INFORMATION: Discussion The Civil Aviation Authority—The Netherlands (CAA-NL), which is the aviation authority for the Netherlands, has issued Dutch Airworthiness Directive NL-2005-015, dated November 30, 2005 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states: During scheduled X-ray inspections of Fokker 50 (F27 Mark 050) engine mounting frames, welding defects were discovered. In two forward frames and one aft frame, defects were found in a total of 4 weld locations. Investigation showed that during manufacture of the frames, when the tubes were welded to the end fittings, unintentional sideways movement of the electric arc resulted in some welds running beside the borderline for a part of the tube circumference. Where a weld runs beside the borderline, there is no connection between tube and end fitting for that part of the circumference, directly affecting the structural integrity of the engine mounting frame connections. The defective welding process appears to have happened at some of the welds in an unknown number of engine mounting frames. This condition, if not corrected, could lead to failure of the engine mounting frame in cases where multiple welds are severely affected, potentially resulting in in-flight loss of an engine. Since an unsafe condition had been identified that may exist on aircraft of the same type design, Airworthiness Directive NL-2005-007 was issued to require * * * a one-time inspection for improper welds. The present AD further specifies the criteria and compliance times for the follow-up NDT (non-destructive test) inspection and repair or replacement of engine mounting frames, as necessary. Corrective action includes contacting Fokker for repair instructions and repair. You may obtain further information by examining the MCAI in the AD docket. Relevant Service Information Fokker Services B.V. has issued the service information identified in the following table. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI. Service Information Fokker Service Bulletin Date Component Service Bulletin F8200-035-71-10 May 30, 2005. Component Service Bulletin F8200-035-71-11 October 25, 2005. Service Bulletin SBF50-71-048 May 30, 2005. Service Bulletin SBF50-71-049 October 25, 2005. FAA's Determination and Requirements of This AD This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design. There are no products of this type currently registered in the United States. However, this rule is necessary to ensure that the described unsafe condition is addressed if any of these products are placed on the U.S. Register in the future. Differences Between the AD and the MCAI or Service Information We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information. We might also have required different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the AD. FAA's Determination of the Effective Date Since there are currently no domestic operators of this product, notice and opportunity for public comment before issuing this AD are unnecessary. Comments Invited This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2007-0639; Directorate Identifier 2007-NM-003-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments. We will post all comments we receive, without change, to *http://www.regulations.gov,* including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD. 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 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 this AD:* 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. 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 FAA amends § 39.13 by adding the following new AD: **2008-13-01 Fokker Services B.V.:** Amendment 39-15564. Docket No. FAA-2008-0639; Directorate Identifier 2007-NM-003-AD. Effective Date
(a)This airworthiness directive
(AD)becomes effective August 1, 2008. Affected ADs
(b)None. Applicability
(c)This AD applies to Fokker Model F27 Mark 050 airplanes, certificated in any category, all serial numbers. Subject
(d)Air Transport Association
(ATA)of America Code 71: Powerplant. Reason
(e)The mandatory continued airworthiness information
(MCAI)states: During scheduled X-ray inspections of Fokker 50 (F27 Mark 050) engine mounting frames, welding defects were discovered. In two forward frames and one aft frame, defects were found in a total of 4 weld locations. Investigation showed that during manufacture of the frames, when the tubes were welded to the end fittings, unintentional sideways movement of the electric arc resulted in some welds running beside the borderline for a part of the tube circumference. Where a weld runs beside the borderline, there is no connection between tube and end fitting for that part of the circumference, directly affecting the structural integrity of the engine mounting frame connections. The defective welding process appears to have happened at some of the welds in an unknown number of engine mounting frames. This condition, if not corrected, could lead to failure of the engine mounting frame in cases where multiple welds are severely affected, potentially resulting in in-flight loss of an engine. Since an unsafe condition had been identified that may exist on aircraft of the same type design, Airworthiness Directive NL-2005-007 was issued to require * * * a one-time inspection for improper welds. The [MCAI supersedes Airworthiness Directive NL-2005-007 and] further specifies the criteria and compliance times for the follow-up NDT (non-destructive test) inspection and repair or replacement of engine mounting frames, as necessary. Corrective action includes contacting Fokker for repair instructions and repair. Actions and Compliance
(f)Unless already done, do the following actions.
(1)Within 2 months after the effective date of this AD, inspect the engine mounting frames to identify those that have any sideways deviations in the welds, in accordance with Part 3 of the Accomplishment Instructions of Fokker Service Bulletin SBF50-71-048, dated May 30, 2005. When deviations are found that are less than or equal to 2.0 mm, no further action is required on that frame and the aircraft may be returned to service.
(2)When, during the inspection required by paragraph (f)(1) of this AD, deviations are found that are greater than 2.0 mm but less than or equal to 2.5 mm on any of the welds of the engine mounting frame, except those of tubes 7, 8, and 12 of the rear frame: Within 12 months after the effective date of this AD, NDT (non-destructive test) inspect the affected frame tubes in accordance with Part 3 of the Accomplishment Instructions of Fokker Service Bulletin SBF50-71-049, dated October 25, 2005.
(3)When, during the inspection required by paragraph (f)(1) of this AD, deviations are found that are greater than 2.5 mm but less than or equal to 3.0 mm on any of the welds of the engine mounting frame, except those of tubes 7, 8, and 12 of the rear frame: Within 9 months after the effective date of this AD, NDT-inspect the affected frame tubes in accordance with Part 3 of the Accomplishment Instructions of Fokker Service Bulletin SBF50-71-049, dated October 25, 2005.
(4)When, during the inspection required by paragraph (f)(1) of this AD, deviations are found that are greater than 3.0 mm but less than or equal to 3.5 mm on any of the welds of the engine mounting frame, except those of tubes 7, 8, and 12 of the rear frame: Within 6 months after the effective date of this AD, NDT-inspect the affected frame tubes in accordance with Part 3 of the Accomplishment Instructions of Fokker Service Bulletin SBF50-71-049, dated October 25, 2005.
(5)When, during the inspection required by paragraph (f)(1) of this AD, deviations are found that are greater than 3.5 mm but less than or equal to 5.0 mm on any of the welds of the engine mounting frame, except those of tubes 7, 8, and 12 of the rear frame: Within 3 months after the effective date of this AD, NDT-inspect the affected frame tubes in accordance with Part 3 of the Accomplishment Instructions of Fokker Service Bulletin SBF50-71-049, dated October 25, 2005.
(6)When, during the inspection required by paragraph (f)(1) of this AD, deviations are found that are greater than 2.0 mm but less than or equal to 5.0 mm on tubes 7, 8, and 12 of the rear frame: Within 3 months after the effective date of this AD, NDT-inspect the affected frame tubes in accordance with Part 3 of the Accomplishment Instructions of Fokker Service Bulletin SBF50-71-049, dated October 25, 2005.
(7)Within 7 days after doing any NDT-inspection required by this AD, or within 30 days after the effective date of this AD, whichever occurs later, report all findings to Fokker Services B.V., Technical Services Dept., P.O. Box 231, 2150 AE Nieuw-Vennep, the Netherlands.
(8)Within 30 days after reporting in accordance with paragraph (f)(7) of this AD, or within 30 days after the effective date of this AD, whichever occurs later, repair any frame deviation in accordance with a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, or by the European Aviation Safety Agency
(EASA)(or its designated agent).
(9)When, during the inspection required by paragraph (f)(1) of this AD, deviations are found exceeding 5 mm, before further flight, report the inspection findings to Fokker Services B.V., Technical Services Dept., P.O. Box 231, 2150 AE Nieuw-Vennep, the Netherlands, and repair any such deviation in accordance with a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, or by EASA (or its designated agent).
(10)Except as provided by paragraphs (f)(10)(i), (f)(10)(ii), (f)(10)(iii), (f)(10)(iv), and (f)(10)(v) of this AD, as of the effective date of this AD, no person may install an engine mounting frame having part number F8200-035-427/-441/-451/-463 (forward frames); F8200-035-425/-443 (A-frames); or F8200-035-403/-439/-449/-461 (rear frames), as a replacement part, unless it has been inspected and found to have deviations less than or equal to 2.0 mm, in accordance with the requirements of Fokker Component Service Bulletin F8200-035-71-10, dated May 30, 2005.
(i)Any frame inspected in accordance with Fokker Component Service Bulletin F8200-035-71-10, and found to have any deviation greater than 2.0 mm but less than or equal to 2.5 mm on any tube, except tubes 7, 8, and 12 of the rear frame, is acceptable for installation. However, if a frame is installed in accordance with this paragraph, it must be NDT-inspected within 12 months after the installation, in accordance with Part 3 of the Accomplishment Instructions of Fokker Service Bulletin SBF50-71-049, dated October 25, 2005.
(ii)Any frame inspected in accordance with Fokker Component Service Bulletin F8200-035-71-10, and found to have any deviation greater than 2.5 mm but less than or equal to 3.0 mm on any tube, except tubes 7, 8, and 12 of the rear frame, is acceptable for installation. However, if a frame is installed in accordance with this paragraph, it must be NDT-inspected within 9 months after the installation, in accordance with Part 3 of the Accomplishment Instructions of Fokker Service Bulletin SBF50-71-049, dated October 25, 2005.
(iii)Any frame inspected in accordance with Fokker Component Service Bulletin F8200-035-71-10, and found to have any deviation greater than 3.0 mm but less than or equal to 3.5 mm on any tube, except tubes 7, 8, and 12 of the rear frame, is acceptable for installation. However, if a frame is installed in accordance with this paragraph, it must be NDT-inspected within 6 months after the installation, in accordance with Part 3 of the Accomplishment Instructions of Fokker Service Bulletin SBF50-71-049, dated October 25, 2005.
(iv)Any frame inspected in accordance with Fokker Component Service Bulletin F8200-035-71-10, and found to have any deviation greater than 3.5 mm but less than or equal to 5.0 mm on any tube, except tubes 7, 8, and 12 of the rear frame, is acceptable for installation. However, if a frame is installed in accordance with this paragraph, it must be NDT-inspected within 3 months after the installation, in accordance with Part 3 of the Accomplishment Instructions of Fokker Service Bulletin SBF50-71-049, dated October 25, 2005.
(v)Any tube 7, 8, or 12 of the rear frame, inspected in accordance with Fokker Component Service Bulletin F8200-035-71-10, and found to have any deviation greater than 2.0 mm but less than or equal to 5.0 mm, is acceptable for installation. However, if a frame is installed in accordance with this paragraph, it must be NDT-inspected within 3 months after the installation, in accordance with Part 3 of the Accomplishment Instructions of Fokker Service Bulletin SBF50-71-049, dated October 25, 2005. FAA AD Differences Note: This AD differs from the MCAI and/or service information as follows: No differences. Other FAA AD Provisions
(g)The following provisions also apply to this AD:
(1)*Alternative Methods of Compliance (AMOCs):* The Manager, International Branch, ANM-116, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Tom Rodriguez, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)227-1137; fax
(425)227-1149. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
(2)*Airworthy Product:* For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.
(3)*Reporting Requirements:* For any reporting requirement in this AD, under the provisions of the Paperwork Reduction Act, the Office of Management and Budget
(OMB)has approved the information collection requirements and has assigned OMB Control Number 2120-0056. Related Information
(h)Refer to Mandatory Continuing Airworthiness Information
(MCAI)Dutch Airworthiness Directive NL-2005-015, dated November 30, 2005, and the service bulletins identified in Table 1 of this AD for related information. Table 1.—Service Information Fokker Service Bulletin Date Component Service Bulletin F8200-035-71-10 May 30, 2005. Component Service Bulletin F8200-035-71-11 October 25, 2005. Service Bulletin SBF50-71-048 May 30, 2005. Service Bulletin SBF50-71-049 October 25, 2005. Material Incorporated by Reference
(i)You must use the service information specified in Table 2 of this AD to do the actions required by this AD, as applicable, unless the AD specifies otherwise.
(1)The Director of the Federal Register approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51.
(2)For service information identified in this AD, contact Fokker Services B.V., Technical Services Dept., P.O. Box 231, 2150 AE Nieuw-Vennep, the Netherlands.
(3)You may review copies at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call
(202)741-6030, or go to: *http://www.archives.gov/federal-register/cfr/ibr-locations.html* . Table 2.—Material Incorporated by Reference Service Bulletin Date Fokker Component Service Bulletin F8200-035-71-10 May 30, 2005. Fokker Service Bulletin SBF50-71-048 May 30, 2005. Fokker Service Bulletin SBF50-71-049 October 25, 2005. Issued in Renton, Washington, on June 26, 2008. Dionne Palermo, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-15711 Filed 7-16-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0543 Directorate Identifier 2007-CE-092-AD; Amendment 39-15607; AD 2008-14-12] RIN 2120-AA64 Airworthiness Directives; Pacific Aerospace Limited Model FU-24 Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule. SUMMARY: We are adopting a new airworthiness directive
(AD)for the products listed above. This AD results from mandatory continuing airworthiness information
(MCAI)issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: To prevent the possible in-flight failure of the vertical fin, leading to loss of control of the aircraft * * * We are issuing this AD to require actions to correct the unsafe condition on these products. DATES: This AD becomes effective August 21, 2008. On August 21, 2008, the Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD. ADDRESSES: You may examine the AD docket on the Internet at *http://www.regulations.gov* or in person at Document Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. FOR FURTHER INFORMATION CONTACT: Karl Schletzbaum, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; *telephone:*
(816)329-4146; *fax:*
(816)329-4090. SUPPLEMENTARY INFORMATION: Discussion We issued a notice of proposed rulemaking
(NPRM)to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the **Federal Register** on May 13, 2008 (73 FR 27479). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states: To prevent the possible in-flight failure of the vertical fin, leading to loss of control of the aircraft * * * The MCAI requires inspections of the vertical fin for cracking, corrosion, scratches, dents, creases, and/or buckling and the repair of any damaged area. Comments We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public. Conclusion We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed. Differences Between This AD and the MCAI or Service Information We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information. We might also have required different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the AD. Costs of Compliance Based on the service information, we estimate that this AD will affect 2 products of U.S. registry. We also estimate that it will take about 1 work-hour per product to comply with basic requirements of this AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $160 or $80 per product. In addition, we estimate that any necessary follow-on actions would take about 24 work-hours and require parts costing $1,000, for a cost of $2,920 per product. We have no way of determining the number of products that may need these actions. 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 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 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. Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.gov* ; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone
(800)647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. 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 FAA amends § 39.13 by adding the following new AD: **2008-14-12 Pacific Aerospace Corporation, Ltd:** Amendment 39-15607; Docket No. FAA-2008-0543; Directorate Identifier 2007-CE-092-AD. Effective Date
(a)This airworthiness directive
(AD)becomes effective August 21, 2008. Affected ADs
(b)None. Applicability
(c)This AD applies to FU-24 airplanes, all serial numbers, certificated in any category. Subject
(d)Air Transport Association of America
(ATA)Code 53: Fuselage. Reason
(e)The mandatory continuing airworthiness information
(MCAI)states: To prevent the possible in-flight failure of the vertical fin, leading to loss of control of the aircraft * * * The MCAI requires inspections of the vertical fin for cracking, corrosion, scratches, dents, creases, and/or buckling and the repair of any damaged area. Actions and Compliance
(f)Unless already done, after August 21, 2008 (the effective date of this AD), do the following actions following Chapter 05, page 25 of the FU-24-950 Series Maintenance Manual:
(1)Before the first flight of each day, visually inspect the vertical stabilizer leading edge skin and fin for any cracking, corrosion, scratches, dents, creases, and/or buckling and repair as necessary. All non-transparent protective coatings and their adhesive must be removed for this inspection.
(2)Within 100 hours time-in-service
(TIS)after August 21, 2008 (the effective date of this AD), and repetitively thereafter at intervals not to exceed 100 hours TIS, perform a detailed inspection of the vertical stabilizer leading edge skin, leading edge, fin skin, and the fin forward attachment point for any cracking, corrosion, scratches, dents, creases, and/or buckling to include:
(i)Inspection of the entire leading edge down to the forward attach fitting and removal of dorsal fin extensions if installed in order to inspect the obscured areas of the fin.
(ii)Inspection of the fin skin for corrosion and cracks, paying particular attention to the center rib rivet holes and the skin joint at the fin base.
(iii)Inspection of the fin forward attachment point for corrosion, removal of the fin tip, and inspection of the top rib for cracks at the skin stiffener cutouts.
(3)If any damage is found during any inspection required in paragraph (f)(1) or (f)(2) of this AD, before further flight, obtain an FAA-approved repair scheme from the manufacturer and incorporate that repair.
(4)The following transparent polyurethane protective tapes have been assessed as suitable for use to re-protect the leading edge and may remain in situ for subsequent inspections, provided they are sound and in a condition to permit visual inspection of the skin beneath them: Manufacturer Product
(i)3M 8591, or 8671, 8672 and 8681HS (aeronautical grade).
(ii)Scapa Aeroshield P2604 (transparent). Note 1: You may apply for an alternative method of compliance
(AMOC)for an alternative to the transparent polyurethane protective tapes listed above. FAA AD Differences Note 2: This AD differs from the MCAI and/or service information as follows:
(1)The inspections required in this AD must be performed by a person authorized under 14 CFR part 43 to perform inspections, as opposed to the MCAI, which allows the holder of a pilot license to perform the inspections.
(2)The 50-hour inspection required in the MCAI goes away because the “before the first flight of each day” inspection captures the intent. Other FAA AD Provisions
(g)The following provisions also apply to this AD:
(1)*Alternative Methods of Compliance (AMOCs):* The Manager, Standards Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Karl Schletzbaum, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone:
(816)329-4146; fax:
(816)329-4090. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
(2)*Airworthy Product:* For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.
(3)*Reporting Requirements:* For any reporting requirement in this AD, under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 *et seq.* ), the Office of Management and Budget
(OMB)has approved the information collection requirements and has assigned OMB Control Number 2120-0056. Related Information
(h)Refer to MCAI Civil Aviation Authority of New Zealand AD DCA/FU24/176C, dated September 27, 2007, for related information. Material Incorporated by Reference
(i)You must use Chapter 05, page 25 of the FU-24-950 Series Maintenance Manual, issued December 1978, to do the actions required by this AD, unless the AD specifies otherwise.
(1)The Director of the Federal Register approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51.
(2)For service information identified in this AD, contact Pacific Aerospace Limited, Hamilton Airport, Private Bag, 3027 Hamilton, New Zealand; *telephone:* +64 7-843-6144; *facsimile:* +64 7-843-6134.
(3)You may review copies at the FAA, Central Region, Office of the Regional Counsel, 901 Locust, Room 506, Kansas City, Missouri 64106; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal-register/cfr/ibr-locations.html* . Issued in Kansas City, Missouri, on June 30, 2008. Kim Smith, Manager, Small Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-16191 Filed 7-16-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-0267; Directorate Identifier 2007-NM-245-AD; Amendment 39-15609; AD 2008-14-14] RIN 2120-AA64 Airworthiness Directives; Boeing Model 747-400 and 747-400D Series Airplanes AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: We are adopting a new airworthiness directive
(AD)for certain Boeing Model 747-400 and 747-400D series airplanes. This AD requires a general visual inspection of the power feeder wire bundle of the auxiliary power unit
(APU)where it crosses the hydraulic system 4 return tube to determine if parts are installed to provide separation between the wire bundle and hydraulic tube. This AD also requires related investigative and corrective actions if necessary. This AD results from a report that the power feeder wire bundle of the APU was found touching the hydraulic system return tube during inspection of an airplane. We are issuing this AD to prevent insufficient clearance between the wire bundle and hydraulic tube that could lead to chafing of the wire bundle, which could cause arcing and a consequent hydraulic fluid fire in an area outside of the smoke detection and fire extinguishing zone; this condition could result in an uncontrolled fire on the airplane. DATES: This AD is effective August 21, 2008. The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of August 21, 2008. ADDRESSES: For service information identified in this AD, contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207. Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.gov* ; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The address for the Docket Office (telephone 800-647-5527) is the Document Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. FOR FURTHER INFORMATION CONTACT: Georgios Roussos, Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)917-6482; fax
(425)917-6590. SUPPLEMENTARY INFORMATION: Discussion We issued a notice of proposed rulemaking
(NPRM)to amend 14 CFR part 39 to include an airworthiness directive
(AD)that would apply to certain Boeing Model 747-400 and 747-400D series airplanes. That NPRM was published in the **Federal Register** on December 4, 2007 (72 FR 68106). That NPRM proposed to require a general visual inspection of the power feeder wire bundle of the auxiliary power unit
(APU)where it crosses the hydraulic system 4 return tube to determine if parts are installed to provide separation between the wire bundle and hydraulic tube. That NPRM also proposed to require related investigative and corrective actions if necessary. Comments We gave the public the opportunity to participate in developing this AD. We considered the three comments received. Supportive Comment The commenters Adam W. Rocks and Boeing support the NPRM. Request To Revise Applicability Brady J. Mitchell, an employee of Boeing, requests that all Boeing Model 747-400 series airplanes converted from a passenger-to-freighter configuration be excluded from the applicability of the NPRM. Mr. Mitchell states that those airplanes will have new hydraulic tubes and eliminate the possibility of an insufficient clearance or potential chafing condition between the tubes and the power feeder wire bundles of the APU between stations 2040 and 2060. Mr. Mitchell concludes that such a configuration change fulfills the requirements in paragraph
(f)of the NPRM. We do not agree. We have reviewed the details of the passenger-to-freighter conversion to which the commenter refers. We have determined that there is not a common configuration for each airplane that is converted. Rather, the details of each conversion are likely to be different from airplane to airplane. Therefore, each conversion configuration needs to be evaluated to ensure the unsafe condition identified in this AD is corrected. For this reason, providing a blanket exception for all airplanes that are converted to a freighter configuration is not appropriate. However, anyone may apply for an alternative method of compliance
(AMOC)for relief from the requirements of this AD. Under the provisions of paragraph
(h)of this AD, we may consider requests for approval of an AMOC if sufficient data are submitted to substantiate that a passenger-to-freighter configuration change would provide an acceptable level of safety. Conclusion We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting the AD as proposed. Costs of Compliance There are about 462 airplanes of the affected design in the worldwide fleet. This AD affects 61 airplanes of U.S. registry. The required inspection takes 1 work hour per airplane, at an average labor rate of $80 per work hour. Based on these figures, the estimated cost of the AD for U.S. operators is $4,880, or $80 per airplane. 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 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. You can find our regulatory evaluation and the estimated costs of compliance in the AD Docket. 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 FAA amends § 39.13 by adding the following new AD: **2008-14-14 Boeing:** Amendment 39-15609. Docket No. FAA-2007-0267; Directorate Identifier 2007-NM-245-AD. Effective Date
(a)This airworthiness directive
(AD)is effective August 21, 2008. Affected ADs
(b)None. Applicability
(c)This AD applies to Boeing Model 747-400 and 747-400D series airplanes, certificated in any category; as identified in Boeing Special Attention Service Bulletin 747-24-2257, Revision 1, dated August 2, 2007. Unsafe Condition
(d)This AD results from a report that the power feeder wire bundle of the auxiliary power unit
(APU)was found touching the hydraulic system return tube during inspection of an airplane. We are issuing this AD to prevent insufficient clearance between the wire bundle and hydraulic tube that could lead to chafing of the wire bundle, which could cause arcing and a consequent hydraulic fluid fire in an area outside of the smoke detection and fire extinguishing zone; this condition could result in an uncontrolled fire on 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. Inspection and Related Investigative and Corrective Actions
(f)Within 24 months after the effective date of this AD, do a general visual inspection of the power feeder wire bundle of the APU where it crosses the hydraulic system 4 return tube to determine if parts are installed to provide separation between the wire bundle and hydraulic tube, and do all the related investigative and corrective actions as applicable, by accomplishing all of the actions specified in the Accomplishment Instructions of Boeing Special Attention Service Bulletin 747-24-2257, Revision 1, dated August 2, 2007. The related investigative and corrective actions must be accomplished before further flight after the inspection. Credit for Actions Done According to Previous Issue of Service Bulletin
(g)Actions done before the effective date of this AD in accordance with Boeing Special Attention Service Bulletin 747-24-2257, dated May 18, 2006, are acceptable for compliance with the corresponding requirements of paragraph
(f)of this AD. Alternative Methods of Compliance (AMOCs) (h)(1) The Manager, Seattle 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)To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO. Material Incorporated by Reference
(i)You must use Boeing Special Attention Service Bulletin 747-24-2257, Revision 1, dated August 2, 2007, to do the actions required by this AD, unless the AD specifies otherwise.
(1)The Director of the Federal Register approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51.
(2)For service information identified in this AD, contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207.
(3)You may review copies of the service information incorporated by reference at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the National Archives and Records Administration (NARA). For information on the availability of this material at 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 June 27, 2008. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-15710 Filed 7-16-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0362; Directorate Identifier 2007-NM-308-AD; Amendment 39-15611; AD 2008-14-16] RIN 2120-AA64 Airworthiness Directives; 328 Support Services GmbH Dornier Model 328-100 and -300 Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule. SUMMARY: We are adopting a new airworthiness directive
(AD)for the products listed above. This AD results from mandatory continuing airworthiness information
(MCAI)originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: At least one incident has occurred where, immediately after take-off, the passenger door of a Dornier 328 completely opened. * * * Substantial damage to the door, handrails, door hinge arms and fuselage skin were found. * * * Although final proof could not be obtained, the most likely way in which the door opened was that the door handle was inadvertently operated during the take-off run. [T]his Airworthiness Directive
(AD)aims to prevent further incidents of inadvertent opening and possible detachment of a passenger door in-flight, likely resulting in damage to airframe and systems and, under less favorable circumstances, loss of control of the aircraft. We are issuing this AD to require actions to correct the unsafe condition on these products. DATES: This AD becomes effective August 21, 2008. The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of August 21, 2008. ADDRESSES: You may examine the AD docket on the Internet at *http://www.regulations.gov* or in person at the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC. FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)227-2125; fax
(425)227-1149. SUPPLEMENTARY INFORMATION: Discussion We issued a notice of proposed rulemaking
(NPRM)to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the **Federal Register** on March 27, 2008 (73 FR 16219). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states: At least one incident has occurred where, immediately after take-off, the passenger door of a Dornier 328 completely opened. The flight crew reportedly had no cockpit indication or audible chime prior to this event. The aircraft returned to the departure airfield and made an uneventful emergency landing. Substantial damage to the door, handrails, door hinge arms and fuselage skin were found. The subsequent investigation could not find any deficiency in the design of the main cabin door locking mechanism. In addition, no technical failure could be determined that precipitated the event. The flight data recorder showed that the door was closed and locked before take-off and opened shortly afterward. Although final proof could not be obtained, the most likely way in which the door opened was that the door handle was inadvertently operated during the take-off run. In response to the incident, AvCraft (the TC (type certificate) holder at the time) developed a placard set to warn the occupants against touching the door handle, as well as a structural modification of the passenger door hinge supports to make certain that the door does not separate from the aircraft when inadvertently opened during flight, allowing a safe descent and landing. Although the event described above did not prevent the flight crew from landing the aircraft safely, the condition of the aircraft immediately after the opening of the door has been determined to have been unsafe. [T]his Airworthiness Directive
(AD)aims to prevent further incidents of inadvertent opening and possible detachment of a passenger door in-flight, likely resulting in damage to airframe and systems and, under less favorable circumstances, loss of control of the aircraft. Corrective actions include installing warning placards on the doors, and doing a modification that includes replacing the hinge supports and support struts of the passenger doors with new, improved hinge supports and support struts. You may obtain further information by examining the MCAI in the AD docket. Comments We gave the public the opportunity to participate in developing this AD. We considered the comment received. The commenter provided information on an incident that occurred on a Dornier Model 228 airplane and asked for the procedure for reporting the incident to additional agencies so that appropriate action is taken. The applicability in the NPRM is for Dornier Model 328-100 and -300 airplanes; therefore, the comment does not apply to this AD. The comment has been forwarded to the appropriate FAA office and will be addressed by that office accordingly. Conclusion We reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting the AD as proposed. Differences Between This AD and the MCAI or Service Information We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information. We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD. Costs of Compliance We estimate that this AD will affect 106 products of U.S. registry. We also estimate that it will take 38 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $80 per work-hour. Required parts will cost about $11,961 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $1,590,106, or $15,001 per product. 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 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 this AD:* 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. Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.gov* ; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone
(800)647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. 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 FAA amends § 39.13 by adding the following new AD: **2008-14-16 328 Support Services GmbH (Formerly AvCraft Aerospace GmbH formerly Fairchild Dornier GmbH, formerly Dornier Luftfahrt GmbH):** Amendment 39-15611. Docket No. FAA-2008-0362; Directorate Identifier 2007-NM-308-AD. Effective Date
(a)This airworthiness directive
(AD)becomes effective August 21, 2008. Affected ADs
(b)None. Applicability
(c)This AD applies to 328 Support Services GmbH Dornier Model 328-100 airplanes, having serial numbers (S/Ns) 3005 through 3098, 3100, 3101, 3106, 3107, 3109, 3110, 3112, 3113, 3115, 3117 and 3119; and Model 328-300 airplanes, having S/Ns 3102, 3105, 3108, 3111, 3114, 3116, 3118, and 3120 through 3224; certificated in any category. Subject
(d)Air Transport Association
(ATA)of America Code 11: Placards and Markings; and Code 52: Doors. Reason
(e)The mandatory continuing airworthiness information
(MCAI)states: At least one incident has occurred where, immediately after take-off, the passenger door of a Dornier 328 completely opened. The flight crew reportedly had no cockpit indication or audible chime prior to this event. The aircraft returned to the departure airfield and made an uneventful emergency landing. Substantial damage to the door, handrails, door hinge arms and fuselage skin were found. The subsequent investigation could not find any deficiency in the design of the main cabin door locking mechanism. In addition, no technical failure could be determined that precipitated the event. The flight data recorder showed that the door was closed and locked before take-off and opened shortly afterward. Although final proof could not be obtained, the most likely way in which the door opened was that the door handle was inadvertently operated during the take-off run. In response to the incident, AvCraft (the TC (type certificate) holder at the time) developed a placard set to warn the occupants against touching the door handle, as well as a structural modification of the passenger door hinge supports to make certain that the door does not separate from the aircraft when inadvertently opened during flight, allowing a safe descent and landing. Although the event described above did not prevent the flight crew from landing the aircraft safely, the condition of the aircraft immediately after the opening of the door has been determined to have been unsafe. [T]his Airworthiness Directive
(AD)aims to prevent further incidents of inadvertent opening and possible detachment of a passenger door in-flight, likely resulting in damage to airframe and systems and, under less favorable circumstances, loss of control of the aircraft. Corrective actions include installing warning placards on the doors, and doing a modification that includes replacing the hinge supports and support struts of the passenger doors with new, improved hinge supports and support struts. Actions and Compliance
(f)Unless already done, do the following actions.
(1)Within 30 days after the effective date of this AD, install warning placards on the inside of the passenger door and service doors, in accordance with the Accomplishment Instructions of Dornier Service Bulletin SB-328-11-454 (for Model 328-100 airplanes) or SB-328J-11-209 (for Model 328-300 airplanes), both dated May 3, 2004, as applicable.
(2)Within 12 months after the effective date of this AD, modify the hinge supports and support struts of the passenger doors, in accordance with the Accomplishment Instructions of Dornier Service Bulletin SB-328-52-460 (for Model 328-100 airplanes) or SB-328J-52-213, (for Model 328-300 airplanes), both dated February 4, 2005, as applicable. FAA AD Differences Note: This AD differs from the MCAI and/or service information as follows: No differences. Other FAA AD Provisions
(g)The following provisions also apply to this AD:
(1)*Alternative Methods of Compliance (AMOCs):* The Manager, International Branch, ANM-116, FAA, Transport Airplane Directorate, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Dan Rodina, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)227-2125; fax
(425)227-1149. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
(2)*Airworthy Product:* For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.
(3)*Reporting Requirements:* For any reporting requirement in this AD, under the provisions of the Paperwork Reduction Act, the Office of Management and Budget
(OMB)has approved the information collection requirements and has assigned OMB Control Number 2120-0056. Related Information
(h)Refer to MCAI European Aviation Safety Agency
(EASA)Airworthiness Directive 2007-0199, dated July 25, 2007 (corrected July 26, 2007), and the service bulletins described in Table 1 of this AD, for related information. Table 1.—Service Information Dornier Service Bulletin Dated SB-328-11-454 May 3, 2004. SB-328-52-460 February 4, 2005. SB-328J-11-209 May 3, 2004. SB-328J-52-213 February 4, 2005. Material Incorporated by Reference
(i)You must use the service information specified in Table 2 of this AD to do the actions required by this AD, unless the AD specifies otherwise. Table 2.—Material Incorporated by Reference Dornier Service Bulletin Dated SB-328-11-454 May 3, 2004. SB-328-52-460 February 4, 2005. SB-328J-11-209 May 3, 2004. SB-328J-52-213 February 4, 2005. (Only the title page of these documents contains the revision level and date of the documents.)
(1)The Director of the Federal Register approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51.
(2)For service information identified in this AD, contact 328 Support Services GmbH, P.O. Box 1252, D-82231 Wessling, Federal Republic of Germany.
(3)You may review copies at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call
(202)741-6030, or go to: *http://www.archives.gov/federal-register/cfr/ibr-locations.html* . Issued in Renton, Washington, on June 26, 2008. Dionne Palermo, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-15709 Filed 7-16-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0232; Directorate Identifier 2007-NM-309-AD; Amendment 39-15612; AD 2008-14-17] RIN 2120-AA64 Airworthiness Directives; Airbus Model A330-200 and A340-300 Series Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule. SUMMARY: We are adopting a new airworthiness directive
(AD)for the products listed above. This AD results from mandatory continuing airworthiness information
(MCAI)originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: During fatigue tests
(EF3)on the A340-600, multiple damage were found in the upper side shell structure at skin and frame
(FR)84 & 85 interface, from stringer 6 to 15 LH/RH. This damage occurred between 58,341 and 72,891 simulated Flight Cycles (FC). Due to the higher Design Service Goal and different design ( *e.g.* skin thickness) for A330-200 and A340-300 aircraft series, the damage assessment concluded on [a] potential impact on these aircraft series. The unsafe condition is loss of integrity of the upper shell structure of the fuselage. We are issuing this AD to require actions to correct the unsafe condition on these products. DATES: This AD becomes effective August 21, 2008. The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of August 21, 2008. ADDRESSES: You may examine the AD docket on the Internet at *http://www.regulations.gov* or in person at the U.S. Department of Transportation, Docket Operations, M-30, West Building, Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC. FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)227-1138; fax
(425)227-1149. SUPPLEMENTARY INFORMATION: Discussion We issued a notice of proposed rulemaking
(NPRM)to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the **Federal Register** on March 3, 2008 (73 FR 11364). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states: During fatigue tests
(EF3)on the A340-600, multiple damage were found in the upper side shell structure at skin and frame
(FR)84 & 85 interface, from stringer 6 to 15 LH/RH. This damage occurred between 58,341 and 72,891 simulated Flight Cycles (FC). Due to the higher Design Service Goal and different design ( *e.g.* skin thickness) for A330-200 and A340-300 aircraft series, the damage assessment concluded on [a] potential impact on these aircraft series. In order to allow early detection of cracks which could avoid possible crack propagation and consequently to maintain the structural integrity of the upper side shell structure between FR84 and FR87, this Airworthiness Directive
(AD)mandates an inspection program of this area [for cracking] using a high frequency eddy current
(HFEC)method and a modification to improve the upper shell structure. This Revision 1 is issued to clarify that this AD is not applicable to aircraft A340-300 series on which both AIRBUS modifications 44205 and 45012 have been embodied in production. The unsafe condition is loss of integrity of the upper shell structure of the fuselage between FR84 and FR87. Corrective actions include contacting Airbus and repairing any crack. You may obtain further information by examining the MCAI in the AD docket. Comments We gave the public the opportunity to participate in developing this AD. We considered the comments received. Request To Remove Reference to Modification Air Transport Association
(ATA)on behalf of its member Northwest Airlines (NWA), requests that we remove the reference to Airbus Modification (Mod.) 44205 from paragraph (c), “Applicability,” of the NPRM. The commenters explain that Mod. 44205 defines common structure for Section 19. Mod. 45012, which is in paragraph (f)(1) of the NPRM, modifies the Section 19 upper side shell on A330-200 series airplanes. We disagree. Cracks can develop on this area of Section 19 that affect basic airplanes fitted with the same features (i.e., post-Mod. 44205). For Model A340-300 series airplanes, Mod. 45012 addresses the unsafe condition. Therefore, only Model A340-300 series airplanes on which both Mod. 44205 and 45012 have been done in production are exempt. Analysis further to these findings established that cracking would also affect airplanes post-Mod. 45012 on Model A330-200 series airplanes. The mandated action separates pre- or post-Mod. 45012, as specified in paragraphs (f)(1) and (f)(2) of this AD. We have made no change to the AD in this regard. Request To Exclude Certain Airplanes The same commenters request that we exclude from paragraph (f)(1) and Table 1 of the NPRM airplanes that have Mod. 52974 or 53223 embodied. The commenters explain that paragraph
(c)excludes these airplanes, but paragraph (f)(1) and Table 1 do not exclude them. Without the exclusion, four more NWA airplanes are affected by the AD. We disagree. Paragraph (f)(1), which includes Table 1, refers to paragraph
(c)where the two modifications are listed as exclusions. There is no need to exclude the airplanes again in paragraph (f)(1) or Table 1 of the AD. We have made no change to the AD in this regard. Request To Move “Before Further Flight” Requirement The same commenters request that we move the requirement to “Do all applicable corrective actions before further flight” from paragraph (f)(1) of the NPRM to the “Threshold” column of Table 1 of the NPRM. The commenters explain that moving this statement would make it clear that corrective action is required at the time of the mandated inspection thresholds and not before. We disagree. Paragraph (f)(1)(i) of this AD, which includes Table 1, gives thresholds for doing the HFEC inspection. Paragraph (f)(1)(ii) of this AD also gives a possible threshold for the HFEC inspection. The requirement is to do the applicable corrective actions before further flight. We have made no change to the AD in this regard. Conclusion We reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD as proposed. Differences Between This AD and the MCAI or Service Information We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information. We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD. Costs of Compliance We estimate that this AD will affect about 7 products of U.S. registry. We also estimate that it will take about 601 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $80 per work-hour. Required parts will cost about $52,160 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these costs. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD on the U.S. operators to be $701,680, or $100,240 per product. 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 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 this AD:* 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. Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.gov* ; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone
(800)647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. 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 FAA amends § 39.13 by adding the following new AD: **2008-14-17 Airbus:** Amendment 39-15612. Docket No. FAA-2008-0232; Directorate Identifier 2007-NM-309-AD. Effective Date
(a)This airworthiness directive
(AD)becomes effective August 21, 2008. Affected ADs
(b)None. Applicability
(c)This AD applies to Airbus Model A330-200 and A340-300 series airplanes, certificated in any category, all certified models; all serial numbers on which Airbus Modification 44205 has been embodied in production, except those on which Airbus Modification 52974 or 53223 has been embodied in production. This AD is not applicable to Model A340-300 series airplanes on which both Modifications 44205 and 45012 have been embodied in production. Subject
(d)Air Transport Association
(ATA)of America Code 53: Fuselage. Reason
(e)The mandatory continuing airworthiness information
(MCAI)states: During fatigue tests
(EF3)on the A340-600, multiple damage were found in the upper side shell structure at skin and frame
(FR)84 & 85 interface, from stringer 6 to 15 LH/RH. This damage occurred between 58,341 and 72,891 simulated Flight Cycles (FC). Due to the higher Design Service Goal and different design ( *e.g.* skin thickness) for A330-200 and A340-300 aircraft series, the damage assessment concluded on [a] potential impact on these aircraft series. In order to allow early detection of cracks which could avoid possible crack propagation and consequently to maintain the structural integrity of the upper side shell structure between FR84 and FR87, this Airworthiness Directive
(AD)mandates an inspection program of this area [for cracking] using a high frequency eddy current
(HFEC)method and a modification to improve the upper shell structure. This Revision 1 is issued to clarify that this AD is not applicable to aircraft A340-300 series on which both AIRBUS modifications 44205 and 45012 have been embodied in production. The unsafe condition is loss of integrity of the upper shell structure of the fuselage between FR84 and FR87. Corrective actions include contacting Airbus and repairing any crack. Actions and Compliance
(f)Unless already done, do the following actions.
(1)For Airbus Model A330-200 series airplanes, as identified in paragraph
(c)of this AD, on which Modification 45012 has been embodied in production: At the later of the compliance times specified in paragraphs (f)(1)(i) and (f)(1)(ii) of this AD, do the HFEC inspection for cracking, and corrective actions as applicable; and modify the upper shell structure of the fuselage; in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-53-3152, dated April 10, 2007. Do all applicable corrective actions before further flight.
(i)Prior to the compliance time shown in Table 1 of this AD after the first flight of the airplane, depending on airplane configuration. Table 1.—Compliance Times for Model A330 Series Airplanes With Modification 45012 Embodied Airplane configuration Threshold Pre-modification 48827 (WV20 to WV27) 25,400 total flight cycles. Post-modification 48827 (WV50 to WV56) 17,100 total flight cycles or 94,700 total flight hours, whichever occurs first.
(ii)Within 90 days after the effective date of this AD.
(2)For Airbus Model A330-200 and A340-300 series airplanes as identified in paragraph
(c)of this AD, on which Modification 45012 has not been embodied in production: At the later of the compliance times specified in paragraphs (f)(2)(i) and (f)(2)(ii) of this AD, modify the upper shell structure of the fuselage in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-53-3157 or Airbus Service Bulletin A340-53-4163, both dated July 5, 2006, as applicable.
(i)Prior to the compliance time shown in Table 2 of this AD after the first flight of the airplane. Table 2.—Compliance Times for Model A330-200 and A340-300 Series Airplanes Without Modification 45012 Embodied Airplane series Threshold A330-200 6,600 total flight cycles. A340-300 14,000 total flight cycles.
(ii)Within 90 days after the effective date of this AD. FAA AD Differences Note: This AD differs from the MCAI and/or service information as follows: No differences. Other FAA AD Provisions
(g)The following provisions also apply to this AD:
(1)*Alternative Methods of Compliance (AMOCs):* The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to *Attn:* Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone
(425)227-1138; fax
(425)227-1149. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
(2)*Airworthy Product:* For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.
(3)*Reporting Requirements:* For any reporting requirement in this AD, under the provisions of the Paperwork Reduction Act, the Office of Management and Budget
(OMB)has approved the information collection requirements and has assigned OMB Control Number 2120-0056. Related Information
(h)Refer to MCAI European Aviation Safety Agency
(EASA)Airworthiness Directive 2007-0269R1, dated October 15, 2007; Airbus Service Bulletin A330-53-3152, dated April 10, 2007; Airbus Service Bulletin A330-53-3157, dated July 5, 2006; and Airbus Service Bulletin A340-53-4163, dated July 5, 2006; for related information. Material Incorporated by Reference
(i)You must use the applicable service information specified in Table 3 of this AD to do the actions required by this AD, unless the AD specifies otherwise.
(1)The Director of the Federal Register approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51.
(2)For service information identified in this AD, contact Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France.
(3)You may review copies at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call
(202)741-6030, or go to: *http://www.archives.gov/federal-register/cfr/ibr-locations.html.* Table 3.—Material Incorporated by Reference Service Bulletin Date Airbus Service Bulletin A330-53-3152 April 10, 2007. Airbus Service Bulletin A330-53-3157 July 5, 2006. Airbus Service Bulletin A340-53-4163 July 5, 2006. Issued in Renton, Washington, on June 27, 2008. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-15708 Filed 7-16-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0327; Directorate Identifier 2007-SW-21-AD; Amendment 39-15600; AD 2008-14-05] RIN 2120-AA64 Airworthiness Directives; Agusta S.p.A. Model A109E and A119 Helicopters AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule. SUMMARY: We are adopting a new airworthiness directive
(AD)for Agusta S.p.A. (Agusta) Model A109E and A119 helicopters. This AD results from mandatory continuing airworthiness information
(MCAI)issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The European Aviation Safety Agency (EASA), the Technical Agent for Italy, with which we have a bilateral agreement, states in the MCAI: “Some cases of interference between the hydraulic pipe, P/N 109-0761-65-103, and the tail rotor control rod assembly have been detected on Model A109E helicopters * * * The interference, if not corrected, could damage the hydraulic pipes and lead to the loss of the hydraulic system No. 1 in flight. This AD * * * is issued to extend the same mandatory corrective actions to A119 model due to its design similarity with A109E.” This AD requires actions that are intended to address this unsafe condition. DATES: This AD becomes effective on August 21, 2008. The incorporation by reference of certain publications is approved by the Director of the Federal Register as of August 21, 2008. ADDRESSES: You may examine the AD docket on the Internet at *http://regulations.gov* or in person at the Docket Operations office, U.S. Department of Transportation, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC between 9 a.m. and 5 p.m. Monday through Friday, except Federal holidays. You may get the service information identified in this AD from Agusta, 21017 Cascina Costa di Samarate
(VA)Italy, Via Giovanni Agusta 520, telephone 39
(0331)229111, fax 39
(0331)229605-222595. *Examining The AD Docket:* The AD docket contains the Notice of Proposed Rulemaking (NPRM), the economic evaluation, any comments received, and other information. The street address and operating hours for the Docket Operations office (telephone
(800)647-5527) are in the ADDRESSES section of this AD. Comments will be available in the AD docket shortly after they are received. FOR FURTHER INFORMATION CONTACT: Uday Garadi, Aviation Safety Engineer, FAA, Rotorcraft Directorate, Regulations and Guidance Group, Fort Worth, Texas 76193-0110, telephone
(817)222-5123, fax
(817)222-5961. SUPPLEMENTARY INFORMATION: Discussion We issued an NPRM to amend 14 CFR part 39 to include an AD that would apply to Agusta Model A109E and A119 helicopters on March 10, 2008. That NPRM was published in the **Federal Register** on March 19, 2008 (73 FR 14733). That NPRM proposed the following: • Within the next 50 hours time-in-service
(TIS)and thereafter at intervals not to exceed 100 hours TIS, inspecting for interference between the hydraulic lines, part number (P/N) 109-0761-64-103 and P/N 109-0761-65-103, and the tail rotor control rod assembly, P/N 109-0032-01-41, and, if interference is found, replacing the hydraulic lines with hydraulic lines, P/N 109-0763-96-101 and P/N 109-0763-97-101. • Within 180 days, replacing hydraulic lines, P/N 109-0761-64-103 and P/N 109-0761-65-103, with hydraulic lines, P/N 109-0763-96-101 and P/N 109-0763-97-101. You may obtain further information by examining the MCAI and any related service information in the AD docket. Comments By publishing the NPRM, we gave the public an opportunity to participate in developing this AD. However, we received no comment on the NPRM or on our determination of the cost to the public. Therefore, based on our review and evaluation of the available data, we have determined that air safety and the public interest require adopting the AD as proposed. Relevant Service Information Agusta has issued Bollettino Tecnico
(BT)No. 109EP-73, dated December 4, 2006, applicable to Model A109E helicopters, and BT No. 119-22, dated July 11, 2007, applicable to Model A119 helicopters. The actions described in the MCAI are intended to correct the same unsafe condition as that identified in the service information. Differences Between This AD and the MCAI We have reviewed the MCAI and related service information and, in general, agree with their substance. However, this AD requires replacing the hydraulic lines within 180 days, unless previously accomplished, instead of replacing the hydraulic lines on the dates specified in the MCAI. In making this change, we do not intend to differ substantively from the information provided in the MCAI and related service information. This difference is highlighted in the “Differences Between This AD and the MCAI” section in the AD. Costs of Compliance We estimate that this AD will affect about 78 helicopters of U.S. registry and that it will take about 2 work-hours per helicopter to inspect and 16 work-hours per helicopter to replace the hydraulic lines. The average labor rate is $80 per work-hour. Required parts will cost about $562 per helicopter, assuming these parts are no longer under warranty. However, because the service information lists these parts as covered under warranty, we have assumed that there is no charge for these parts. Therefore, as we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD on U.S. operators to be $112,320, or $1,440 per helicopter. 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 product(s) identified in this rulemaking action. Regulatory Findings We 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. *Therefore, I certify this AD:* 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 an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket. 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 FAA amends § 39.13 by adding the following new AD: **2008-14-05 Agusta. S.p.A.:** Amendment 39-15600. Docket No. FAA-2008-0327; Directorate Identifier 2007-SW-21-AD. Effective Date
(a)This airworthiness directive
(AD)becomes effective on August 21, 2008. Other Affected ADs
(b)None. Applicability
(c)This AD applies to Agusta S.p.A. Model A109E and A119 helicopters, with hydraulic lines, part number (P/N) 109-0761-64-103 or P/N 109-0761-65-103, installed, certificated in any category. Reason
(d)The mandatory continuing airworthiness information
(MCAI)states: “Some cases of interference between the hydraulic pipe, P/N 109-0761-65-103, and the tail rotor control rod assembly have been detected on Model A109E helicopters * * * The interference, if not corrected, could damage the hydraulic pipes and lead to the loss of the hydraulic system No. 1 in flight. This AD * * * is issued to extend the same mandatory corrective actions to A119 model due to its design similarity with A109E.” This AD requires actions that are intended to address this unsafe condition. Actions and Compliance
(e)Within the next 50 hours time-in-service (TIS), unless accomplished previously, and thereafter at intervals not to exceed 100 hours TIS:
(1)Inspect for interference between the hydraulic lines, P/N 109-0761-64-103 and P/N 109-0761-65-103, and the tail rotor control rod assembly, P/N 109-0032-01-41, in accordance with the Compliance Instructions, Part I, paragraph 3, of Agusta Bollettino Tecnico
(BT)No. 109EP-73, dated December 4, 2006 (BT A109E), which is applicable to Model A109E helicopters, or BT 119-22, dated July 11, 2007 (BT 119-22), which is applicable to Model A119 helicopters.
(2)If you find interference between the hydraulic lines and the tail rotor control rod assembly, replace the hydraulic lines, P/N 109-0761-64-103 and P/N 109-0761-65-103, with hydraulic lines, P/N 109-0763-96-101 and P/N 109-0763-97-101, respectively, in accordance with the Compliance Instructions, Part II of BT A109E or BT 119-22, whichever is applicable to your model helicopter.
(f)Within 180 days, replace hydraulic lines, P/N 109-0761-64-103 and P/N 109-0761-65-103, with hydraulic lines, P/N 109-0763-96-101 and P/N 109-0763-97-101, respectively, in accordance with the Compliance Instructions, Part II, of BT A109E or BT 119-22, whichever is applicable to your model helicopter. Differences Between This AD and the MCAI
(g)This AD requires replacement of hydraulic lines, P/N 109-0761-64-103 and P/N 109-0761-65-103, within 180 days, unless previously accomplished, instead of replacing the hydraulic lines on the dates specified in the MCAI. Other Information
(h)Alternative Methods of Compliance (AMOCs): The Manager, Safety Management Group, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Uday Garadi, Aviation Safety Engineer, FAA, Rotorcraft Directorate, Regulations and Guidance Group, Fort Worth, Texas 76193-0110, telephone
(817)222-5123, fax
(817)222-5961. Related Information
(i)MCAI EASA AD No 2007-0231, dated August 23, 2007, contains related information. Air Transport Association of America
(ATA)Tracking Code
(j)ATA Code 2910—Main Hydraulic System. Material Incorporated by Reference
(k)You must use the specified portions of Agusta Bollettino Tecnico No. 109EP-73, dated December 4, 2006, or No. 119-22, dated July 11, 2007, as applicable, to do the actions required.
(1)The Director of the Federal Register approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51.
(2)For service information identified in this AD, contact Agusta, 21017 Cascina Costa di Samarate
(VA)Italy, Via Giovanni Agusta 520, telephone 39
(0331)229111, fax 39
(0331)229605-222595.
(3)You may review copies at the FAA, Office of the Regional Counsel, Southwest Region, 2601 Meacham Blvd., Fort Worth, Texas 76193; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call
(202)741-6030, or go to: *http://www.archives.gov/federal-register/cfr/ibr-locations.html.* Issued in Fort Worth, Texas, on June 19, 2008. Judy I. Carl, Acting Manager, Rotorcraft Directorate, Aircraft Certification Service. [FR Doc. E8-14727 Filed 7-16-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. 2003-NM-33-AD; Amendment 39-15613; AD 2008-15-01] RIN 2120-AA64 Airworthiness Directives; Empresa Brasileira de Aeronautica S.A. (EMBRAER) Model EMB-120, -120ER, -120FC, -120QC, and -120RT Airplanes AGENCY: Federal Aviation Administration, DOT. ACTION: Final rule. SUMMARY: This amendment adopts a new airworthiness directive (AD), applicable to all EMBRAER Model EMB-120 series airplanes, that requires revising the airplane flight manual to include operational limitations for use of the autopilot, installing two placards that advise the flight crew to check the pitch trim before descent, and modifying the elevator trim system, which would terminate the requirements of the AD. The actions specified by this AD are intended to prevent pitch trim upsets if the pitch trim actuators jam or freeze, which could result in reduced controllability of the airplane. This action is intended to address the identified unsafe condition. DATES: Effective August 21, 2008. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of August 21, 2008. ADDRESSES: The service information referenced in this AD may be obtained from Empresa Brasileira de Aeronautica S.A. (EMBRAER), P.O. Box 343—CEP 12.225, Sao Jose dos Campos—SP, Brazil. This information may be examined at the Federal Aviation Administration (FAA), Transport Airplane Directorate, Rules Docket, 1601 Lind Avenue, SW., Renton, Washington. FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone
(425)227-2125; fax
(425)227-1149. SUPPLEMENTARY INFORMATION: A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive
(AD)that is applicable to all EMBRAER Model EMB-120 series airplanes was published as a supplemental notice of proposed rulemaking
(NPRM)in the **Federal Register** on February 8, 2008 (73 FR 7494). That action proposed to require revising the airplane flight manual to include operational limitations for use of the autopilot, installing two placards (with revised language) that advise the flight crew to check the pitch trim before descent, and modifying the elevator trim system, which would terminate the requirements of the AD. New Relevant Service Information The supplemental NPRM referred to EMBRAER Service Bulletins 120-27-0095 and 120-27-0096, both dated February 16, 2007, as the appropriate sources of service information for the elevator trim system modification. EMBRAER has since revised these service bulletins. Service Bulletins 120-27-0095, Revision 01, dated October 30, 2007; and 120-27-0096, Revision 01, dated October 1, 2007; include minor changes but provide no additional work. In this final rule, we have changed paragraph
(d)to refer to Revision 01 of the service bulletins, added new paragraph
(e)to provide credit for the prior accomplishment of the original service bulletins, and re-identified subsequent paragraphs accordingly. Comments Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received. Request to Conditionally Allow Autopilot Re-Engagement SkyWest Airlines, Inc., requests that we revise the NPRM to allow autopilot re-engagement once pitch trim is recovered. According to the commenter, the inability to re-engage the autopilot for the remainder of the flight can place an unreasonable workload on a flightcrew during some of the most critical and demanding phases of flight. We do not agree. We recognize that the inability to re-engage the autopilot could add to the flightcrew's workload during certain phases of flight, but we do not agree that continued flight would be safe with the autopilot re-engaged. When free pitch trim is restored after jamming, the appropriate approach is to continue the flight manually without the autopilot and report the issue to maintenance, rather than re-engaging the autopilot, so the cause of the jam can be evaluated and corrected before further use of the autopilot. We have not changed the AD regarding this issue. Request to Limit Conditions That Require Pitch Trim Check SkyWest requests that we require a pitch trim check only when a pitch trim jam is suspected. The commenter states that the existing criteria are too broad, as they would include extremes of descents in conditions of no ice, no moisture, and outside air temperature in excess of 25 degrees Celsius. We disagree. Jamming of the trim system is not dependent on the environmental conditions. Internal friction of the trim actuators may gradually increase in normal use regardless whether the actuator is internally contaminated. We have not changed the AD regarding this issue. Conclusion After careful review of the available data, including the comments noted above, the FAA has determined that air safety and the public interest require adopting the AD with the changes described previously. We also determined that these changes will not increase the economic burden on any operator or increase the scope of the AD. Cost Impact The following table provides the estimated costs for U.S. operators to comply with this AD. Estimated Costs Action Work hours Average labor rate per hour Parts Cost per product Number of U.S.-registered airplanes Fleet cost AFM revisions 1 $80 $0 $80 103 $8,240 Placard installation 2 80 182 342 103 35,226 Actuator replacement 7 80 16,670 17,230 103 1,774,690 Cable replacement 14 80 1,050 2,170 103 223,510 The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions. 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 Impact The regulations adopted herein 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. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132. For the reasons discussed above, I certify that this action
(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. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES . List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration 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. Section 39.13 is amended by adding the following new airworthiness directive: **2008-15-01 Empresa Brasileira De Aeronautica S.A. (EMBRAER):** Amendment 39-15613. Docket 2003-NM-33-AD. *Applicability:* All Model EMB-120, -120ER, -120FC, -120QC, and -120RT airplanes, certificated in any category. *Compliance:* Required as indicated, unless accomplished previously. To prevent pitch trim upsets if the pitch trim actuators jam or freeze, which could result in reduced controllability of the airplane, accomplish the following: Revision of Airplane Flight Manual (AFM): AFM-120/794
(a)Within 100 flight hours after the effective date of this AD, revise the FAA-approved AFM, EMBRAER AFM-120/794, as specified in paragraphs (a)(1) and (a)(2) of this AD. These actions may be accomplished by inserting a copy of this AD into the AFM.
(1)Revise the FLIGHT CONTROLS FAILURES paragraph of the Abnormal Procedures section by replacing the existing ELEVATOR TRIM JAMMING procedure with the following: “ELEVATOR TRIM JAMMING Control Wheel Hold Firmly Autopilot Disengage Airspeed Reduce Note: Minimum airspeed with flap 0°—160 KIAS Pitch trim command Check all switches and elevator trim wheel If pitch trim is recovered: Re-trim the airplane and continue the flight with the autopilot disengaged, not exceeding the airspeed when the trim was recovered. If pitch trim is not recovered: Land at the nearest suitable airport. Approach and landing configuration: Landing gear Down Flaps 25 Airspeed Vref25 *CAUTION:* DO NOT TRY TO RE-ENGAGE THE AUTOPILOT.”
(2)Revise the Normal Procedures section of the AFM, after the current checklist item for activating the FASTEN BELTS switch, by inserting the following: “PITCH TRIM SYSTEM CHECK Control Wheel Hold firmly Autopilot Disengage Power Levers As required Elevator Trim Wheels As required *CAUTION:* MANUALLY SET THE ELEVATOR TRIM WHEELS TO THE REQUIRED DESCENT ATTITUDE. If any trim system binding (if trim wheel rotates more than one trim wheel index mark after being released), or abnormal trim operation is observed: Elevator Trim Jamming Procedure Perform *CAUTION:* DO NOT TRY TO RE-ENGAGE THE AUTOPILOT. If no abnormal trim operation is observed: Flight Director Vertical Mode As required Autopilot Reengage” AFM Revision: Collins APS-65B Autopilot AFM Supplement
(b)Concurrently with the AFM revisions required by paragraph
(a)of this AD, revise the Limitations section of the Collins APS-65B Autopilot System Supplement to include the following (this may be accomplished by inserting a copy of this AD into the AFM Supplement): “1) The autopilot must not be used during descent unless a trim check has been performed successfully prior to descent, as follows: PITCH TRIM SYSTEM CHECK Control Wheel Hold firmly Autopilot Disengage Power Levers As required Elevator Trim Wheels As required *CAUTION:* MANUALLY SET THE ELEVATOR TRIM WHEELS TO THE REQUIRED DESCENT ATTITUDE. If any trim system binding (if trim wheel rotates more than one trim wheel index mark after being released), or abnormal trim operation is observed: Elevator Trim Jamming Procedure Perform *CAUTION:* DO NOT TRY TO RE-ENGAGE THE AUTOPILOT. If no abnormal trim operation is observed: Flight Director Vertical Mode As required Autopilot Reengage 2) If an elevator trim jamming is detected during flight and the pitch trim system resumes normal operation on ground, only a ferry flight using a special permit may be performed to return the aircraft to a maintenance base for replacement of the actuators. In this case, the use of autopilot is prohibited.” Placard Installation
(c)Within 300 flight hours after the effective date of this AD, install two placards on the glareshield, advising the flight crew to check the pitch trim before initial descent, in accordance with Part II of the Accomplishment Instructions of EMBRAER Service Bulletin 120-25-0262, Change 02, dated October 30, 2003. Elevator Trim System Modification
(d)Within 36 months after the effective date of this AD, modify the elevator trim system, in accordance with the Accomplishment Instructions of EMBRAER Service Bulletin 120-27-0095, Revision 01, dated October 30, 2007; and EMBRAER Service Bulletin 120-27-0096, Revision 01, dated October 1, 2007. Accomplishment of the modification terminates the requirements of paragraphs (a), (b), and
(c)of this AD, and the corresponding AFM revisions and placards may be removed. Credit for Prior Accomplishment
(e)A modification done before the effective date of this AD in accordance with EMBRAER Service Bulletins 120-27-0095 and 120-27-0096, both dated February 16, 2007, is acceptable for compliance with the requirements of paragraph
(d)of this AD. Parts Installation
(f)As of 36 months after the effective date of this AD, no person may install, on any airplane, an elevator trim tab actuator or control cable having a part number identified in Table 1 of this AD. Table 1.—Prohibited Parts Part Part No. Elevator trim tab actuator 120-19685-001; 120-19685-003; 120-19685-007; 120-38650-001; 120-39205-001; 5299; 5299-1. Control cable 120-27729-095; 120-27729-097; 120-31370-095; 120-31370-097. Alternative Methods of Compliance (g)(1) The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(2)To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO. Incorporation by Reference
(h)You must use the service information contained in Table 2 of this AD to do the actions required by this AD, unless the AD specifies otherwise.
(1)The Director of the Federal Register approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51.
(2)For service information identified in this AD, contact Empresa Brasileira de Aeronautica S.A. (EMBRAER), P.O. Box 343—CEP 12.225, Sao Jose dos Campos—SP, Brazil.
(3)You may review copies of the service information that is incorporated by reference at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.* Table 2.—Material Incorporated by Reference Service Bulletin Revision level Date EMBRAER Service Bulletin 120-25-0262 Change 02 October 30, 2003. EMBRAER Service Bulletin 120-27-0095 Revision 01 October 30, 2007. EMBRAER Service Bulletin 120-27-0096 Revision 01 October 1, 2007. Note 1: The subject of this AD is addressed in Brazilian airworthiness directive 2001-06-01R4, effective August 23, 2007. Effective Date
(i)This amendment becomes effective on August 21, 2008. Issued in Renton, Washington, on July 3, 2008. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-15969 Filed 7-16-08; 8:45 am] BILLING CODE 4910-13-P SOCIAL SECURITY ADMINISTRATION 20 CFR Part 404 [Docket No. SSA-2006-0086] RIN 0960-AG43 Technical Changes to the Title II Regulations AGENCY: Social Security Administration. ACTION: Direct Final Rule with request for comments. SUMMARY: We are issuing this direct final rule to make technical corrections to our title II regulations affecting the Federal Old-Age, Survivors and Disability Insurance programs. This rule amends our regulations by correcting a cross-reference affecting entitlement to mother's and father's benefits, to include alternatives to the 9-month duration of marriage requirement. We are deleting an out-of-date cross-reference to the definition of “substantially all.” In its place, we are restoring the regulatory definition for “substantially all” that had been inadvertently deleted to show if a grandchild or stepgrandchild is dependent based on our support requirements. Also, we are revising headings in six of our regulations to conform to plain language provisions of Executive Order (E.O.) 12866, as amended. We are also amending one of our regulations for clarity and to correct a typographical error. DATES: *Effective Date:* This direct final rule is effective September 15, 2008 unless adverse or critical comments are received by August 18, 2008. If the effective date is delayed, timely notice will be published in the **Federal Register** . COMMENT DATE: To be sure your comments are considered, we must receive them by August 18, 2008. ADDRESSES: You may submit comments by one of four methods—Internet, facsimile, regular mail, or hand-delivery. Commenters should not submit the same comments multiple times or by more than one method. Regardless of which of the following methods you choose, please state that your comments refer to Docket No. SSA-2006-0086 to ensure that we can associate your comments with the correct regulation: 1. Federal eRulemaking portal at *http://www.regulations.gov.* (This is the most expedient method for submitting your comments, and we strongly urge you to use it.) In the “Comment or Submission” section of the webpage, type “SSA-2006-0086”, select “Go”, and then click “Send a Comment or Submission.” The Federal eRulemaking portal issues you a tracking number when you submit a comment. 2. Telefax to
(410)966-2830. 3. Letter to the Commissioner of Social Security, P.O. Box 17703, Baltimore, Maryland 21235-7703. 4. Deliver your comments to the Office of Regulations, Social Security Administration, 922 Altmeyer Building, 6401 Security Boulevard, Baltimore, Maryland 21235-6401, between 8 a.m. and 4:30 p.m. on regular business days. All comments are posted on the Federal eRulemaking portal, although they may not appear for several days after receipt of the comment. You may also inspect the comments on regular business days by making arrangements with the contact person named in this preamble. *Caution:* All comments we receive from members of the public are available for public viewing on the Federal eRulemaking portal at *http://www.regulations.gov.* Therefore, you should be careful to include in your comments only information that you wish to make publicly available on the Internet. We strongly urge you not to include any personal information, such as your Social Security number or medical information, in your comments. FOR FURTHER INFORMATION CONTACT: Mary Jayne Neubauer, Social Insurance Specialist, Office of Income Security Programs, Social Security Administration, 6401 Security Boulevard, Baltimore, MD 21235-6401,
(410)966-7303. For information on eligibility or filing for benefits, call our national toll-free number, 1-800-772-1213 or TTY 1-800-325-0778, or visit our Internet site, Social Security Online, at *http://www.socialsecurity.gov.* SUPPLEMENTARY INFORMATION: Electronic Version The electronic file of this document is available on the date of publication in the **Federal Register** at *http://www.gpoaccess.gov/fr/index.html.* Explanation of Changes Correction of cross-reference in section 404.339(a)—Who is entitled to mother's or father's benefits. Section 404.339 describes how a person becomes entitled to mother's or father's benefits. Section 404.339(a) currently requires that the person be the widow or widower of the insured “and meet the conditions described in § 404.335(a)(1)”, which refers to a 9-month duration of marriage requirement for a widow or widower. This cross-reference is incorrect because it does not include the alternatives to the 9-month duration of marriage requirement, which are contained in § 404.335(a)(2), (a)(3) and (a)(4). Therefore, we are correcting the cross-reference to refer to § 404.335(a). Technical correction to section 404.340—Who is entitled to mother's or father's benefits as a surviving divorced spouse. Currently, § 404.340 of the regulations explains that for you to be entitled to mother's or father's benefits as a surviving divorced spouse, you must be a surviving divorced wife or surviving divorced husband of someone who was fully or currently insured when he or she died. We are amending the introductory text in § 404.340 to add “on the earnings record” after “husband” for clarity and consistency with the introductory language of § 404.339 of our regulations. We are also making a correction in the introductory text to correct a typographical error. Technical corrections to sections 404.348—When a child living with you is “in your care”—and section 404.762— Evidence of having a child in your care. In 1979, we published final regulations reorganizing and restating in simpler language, the rules on requirements for entitlement to Social Security benefits and how we determine family relationships when benefits are requested as the insured's dependent or survivor. (44 FR 34479.) We have found that the wording of the introductory text in §§ 404.348 and 404.762 could be misinterpreted so that it would inaccurately reflect the Social Security Act (the Act) and the operating policies that we follow. Therefore, in this direct final regulation, we are making clarifying corrections to those sections by removing the language that could be misinterpreted. Paragraphs (b)(1) and (c)(1) of section 202 of the Act explain that benefits are payable to a wife or husband of an individual entitled to Title II benefits. Paragraph (g)(1) of section 202 of the Act explains that benefits are also payable to a mother or father who is the widow or widower of a deceased insured individual (including a surviving divorced parent), if he or she has an entitled child of the insured in his or her care. Currently, our regulations at § 404.348 provide the conditions for child in care and define the beneficiaries who can be entitled based on having a child of the insured in care. However, they do not explain that benefits can be payable to husbands before they become 62 years old and surviving divorced mothers and surviving divorced fathers, if they have the insured's entitled child in-care. Section 404.348, unlike § 404.762, does not clearly state that benefits are payable to mothers and fathers as the widows or widowers of the insured. In addition, in discussing the evidentiary requirements for establishing that a child is in-care, § 404.762 does not explain that benefits are payable to husbands and surviving divorced fathers. The inadvertent omission of husband's and surviving divorced mother's and surviving divorced father's benefits from the regulation defining child-in-care and the omission of husband's and surviving divorced father's benefits from the regulation describing the child in-care evidentiary requirements was an oversight when the regulations were amended in 1979 to remove gender-based distinctions. We properly define the individuals who are entitled to benefits based on having a child of the insured in care in §§ 404.330, 404.339 and 404.340 of the regulations. We have determined that defining the categories of beneficiaries in §§ 404.348 and 404.762 is not relevant to the subject regulations—§§ 404.330, 404.339 and 404.340. Therefore, we are removing the first sentences in §§ 404.348 and 404.762 because they are incomplete and covered more fully in other sections. Restoring definition of “substantially all” and amending language to eliminate gender-based distinctions in section 404.364—When a grandchild or stepgrandchild is dependent. To be entitled to benefits as a grandchild or stepgrandchild of an insured person, the child must be dependent on the insured. Consistent with requirements in section 202(d)(9)(A) of the Act, § 404.364 explains when a grandchild or stepgrandchild applying for benefits is considered dependent. One of the dependency requirements is that a grandchild or stepgrandchild must have been both living with and receiving at least one-half support from the insured for the 1-year period before the insured died or became entitled to old-age or disability benefits. Under section 202(d)(9)(B) of the Act and § 404.364(b) of our regulations, if a grandchild or stepgrandchild was born during this 1-year period, the living-with and support requirements must be met for “substantially all” of the period beginning on the child's date of birth. Section 404.364(b) refers to § 404.362(b)(1)(iii) for a definition of “substantially all.” However, we inadvertently deleted § 404.362(b)(1)(iii) from the regulations in 1991. (56 FR 23999.) We are defining “substantially all” in a new paragraph
(c)of § 404.364, using essentially the deleted language. Under this definition, the “substantially all” requirement is met if, at the applicable time, the insured was living with the child and providing at least one-half of the child's support and any period during which the grandparent or stepgrandparent was not living with the child and providing at least one-half support did not exceed the lesser of 3 months or one-half of the period beginning with the month of the child's birth. We are also amending paragraph
(b)of § 404.364 to insert “or her” after “him” to eliminate gender-based distinctions. Revision of Headings to Clarify These Regulations We are rewriting the headings for §§ 404.339, 404.340, 404.348, 404.349, 404.364 and 404.762 to comply with the provisions of Executive Order 12866, as amended, requiring that each agency write all rules in plain language. Regulatory Procedures Pursuant to sections 205(a), 702(a)(5), and 1631(d)(1) of the Act, 42 U.S.C. 405(a), 902(a)(5), 1383(d)(1), we follow the Administrative Procedure Act
(APA)rulemaking procedures specified in 5 U.S.C. 553 in the development of our regulations. The APA provides exceptions to its prior notice and public comment procedures when an agency finds there is good cause for dispensing with such procedures on the basis that they are impracticable, unnecessary, or contrary to the public interest. In the case of this rule, we believe that, under 5 U.S.C. 553(b)(B), good cause exists for issuing these regulatory changes as a direct final rule, without prior public comment. As we explained above, in this rule, we are merely clarifying and making minor technical changes to some of our regulations. The clarifications and changes do not involve substantial exercise of our discretion, but merely correct typographical errors and incorrect cross references, make our regulations internally consistent, and restore language that had been inadvertently deleted from the regulations. Therefore, we have determined that opportunity for prior public comment is unnecessary, and we are issuing these regulations as a direct final rule. However, we are inviting public comment on the changes made by this rule and will consider any responsive comments received within 30 days of the publication of this direct final rule. In addition, we find good cause for dispensing with the 30-day delay in the effective date of a substantive rule, provided for by 5 U.S.C. 553(d). As explained above, we are revising our title II rules to correct minor technical errors and to clarify the rules. Therefore, we find that it is in the public interest to make this rule effective upon publication. Executive Order 12866, as Amended We have consulted with the Office of Management and Budget
(OMB)and determined that this final rule does not meet the criteria for a significant regulatory action under Executive Order 12866, as amended. Thus, it was not subject to OMB review. We have also determined that this rule meets the plain language requirement of Executive Order 12866, as amended. Regulatory Flexibility Act We certify that this direct final rule will not have a significant economic impact on a substantial number of small entities as it affects individuals only. Therefore, a regulatory flexibility analysis as provided in the Regulatory Flexibility Act, as amended, is not required. Paperwork Reduction Act This rule imposes no additional reporting or recordkeeping requirements requiring OMB clearance. (Catalog of Federal Domestic Assistance Program Nos. 96.001, Social Security—Disability Insurance; 96.002, Social Security—Retirement Insurance; 96.004, Social Security—Survivors Insurance.) List of Subjects in 20 CFR Part 404 Administrative practice and procedure, Blind, Disability benefits, Old-age, Survivors and Disability Insurance, Reporting and recordkeeping requirements, Social Security. Dated: July 10, 2008. Michael J. Astrue, Commissioner of Social Security. For the reasons set out in the preamble, we are amending part 404 of chapter III of title 20 of the Code of Federal Regulations as set forth below: PART 404—FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950—) Subpart D—[Amended] 1. The authority citation for subpart D of part 404 continues to read as follows: Authority: Secs. 202, 203(a) and (b), 205(a), 216, 223, 225, 228(a)-(e), and 702(a)(5) of the Social Security Act (42 U.S.C. 402, 403(a) and (b), 405(a), 416, 423, 425, 428(a)-(e), and 902(a)(5)). 2. Amend § 404.339 by revising the heading and paragraph
(a)to read as follows: § 404.339 How do I become entitled to mother's or father's benefits as a surviving spouse?
(a)You are the widow or widower of the insured and meet the conditions described in § 404.335(a); 3. Amend § 404.340 by revising the heading and introductory text to read as follows: § 404.340 How do I become entitled to mother's or father's benefits as a surviving divorced spouse? You may be entitled to mother's or father's benefits as the surviving divorced wife or the surviving divorced husband on the earnings record of someone who was fully or currently insured when she or he died. You are entitled to these benefits if— 4. Amend § 404.348 by revising the heading and the introductory text to read as follows: § 404.348 When is a child living with me in my care? A child who has been living with you for at least 30 days is *in your care* unless— 5. Amend § 404.349 by revising the section heading to read as follows: § 404.349 When is a child living apart from me in my care? 6. Amend § 404.364 by revising the heading and paragraph (b), and by adding paragraph
(c)to read as follows: § 404.364 When is a grandchild or stepgrandchild dependent?
(b)You were living with the insured in the United States and receiving at least one-half of your support from him or her for the year before he or she became entitled to old-age or disability benefits or died; or if the insured had a period of disability that lasted until he or she became entitled to benefits or died, for the year immediately before the month in which the period of disability began. If you were born during the 1-year period, the insured must have lived with you and provided at least one-half of your support for *substantially all* of the period that begins on the date of your birth. Paragraph
(c)of this section explains when the *substantially all* requirement is met.
(c)The “substantially all” requirement will be met if, at one of the times described in paragraph
(b)of this section, the insured was living with you and providing at least one-half of your support, and any period during which he or she was not living with you and providing one-half of your support did not exceed the lesser of 3 months or one-half of the period beginning with the month of your birth. Subpart H—[Amended] 7. The authority citation for subpart H of part 404 continues to read as follows: Authority: Secs. 205(a) and 702(a)(5) of the Social Security Act (42 U.S.C. 405(a) and 902(a)(5)). 8. Amend § 404.762 by revising the heading and the introductory text to read as follows: § 404.762 What is acceptable evidence of having a child in my care? What evidence we will ask for depends upon whether the child is living with you or with someone else. You will be asked to give the following evidence: [FR Doc. E8-16332 Filed 7-16-08; 8:45 am] BILLING CODE 4191-02-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 892 [Docket No. FDA-2005-N-0346] (formerly Docket No. 2005N-0467) Medical Devices; Radiology Devices; Reclassification of Bone Sonometers AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is issuing a final rule to reclassify bone sonometer devices from class III into class II, subject to special controls. FDA is taking this action on its own initiative after reviewing recent scientific and technological studies regarding bone sonometer devices. Elsewhere in this issue of the **Federal Register** , FDA is announcing the availability of a guidance document entitled “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers” that will serve as the special control for these devices. DATES: This final rule is effective August 18, 2008. FOR FURTHER INFORMATION CONTACT: Robert A. Phillips, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3666. SUPPLEMENTARY INFORMATION: I. Regulatory Authority The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law 94-295), the Safe Medical Devices Act
(SMDA)(Public Law 101-629), the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115), the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250), the Medical Devices Technical Corrections Act (MDTCA) (Public Law 108-214), and the Food and Drug Administration Amendments Act (FDAAA), establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval). Under section 513 of the act, devices that were in commercial distribution before May 28, 1976 (the date of enactment of the 1976 amendments), generally referred to as preamendments devices, are classified after FDA has:
(1)Received a recommendation from a device classification panel (an FDA advisory committee);
(2)published the panel's recommendation for comment, along with a proposed regulation classifying the device type; and
(3)published a final regulation classifying the device type. FDA has classified most preamendments devices under these procedures. Devices that were not in commercial distribution prior to May 28, 1976, generally referred to as postamendments devices, are classified automatically by statute (section 513(f) of the act) into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval, unless and until the device is reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, under section 513(i) of the act, to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR part 807. A preamendments device that has been classified into class III may be marketed, by means of premarket notification procedures, without submission of a premarket approval application (PMA), until FDA issues a final regulation under section 515(b) of the act (21 U.S.C. 360e(b)) requiring premarket approval. Section 513(f)(3) of the act allows FDA to initiate reclassification of a postamendment device classified into class III under section 513(f)(1) of the act, or the manufacturer or importer of a device to petition the Secretary of the Department of Health and Human Services for the issuance of an order classifying the device in class I or class II. FDA's regulations in 21 CFR 860.134 set forth the procedures for the filing and review of a petition for reclassification of such class III devices. To change the classification of the device, it is necessary that the proposed new classification have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. II. Regulatory Background of the Device In the **Federal Register** of February 15, 2006 (71 FR 7894), FDA published a proposed rule to reclassify bone sonometers from class III (premarket approval) into class II (special controls) after reviewing current technological and scientific developments. Specifically, the Center for Devices and Radiological Health
(CDRH)reviewed recent studies addressing performance characteristics of bone sonometers manufactured by different companies and determined that, when combined with mitigation measures to offset the risks of use associated with these devices, special controls would be adequate to assure the safety and effectiveness of bone sonometers. Interested persons were invited to comment on the proposed rule by May 16, 2006. FDA also identified the draft guidance document entitled “Draft Guidance for Industry and FDA Staff; Class II Special Controls Draft Guidance Document; Bone Sonometers” as the proposed special control capable of providing reasonable assurance of safety and effectiveness for these devices (71 FR 7976). III. Analysis of Comments and FDA's Response FDA received a number of comments on the proposed rule and draft guidance document. Each of the comments supported the reclassification of bone sonometers from class III into class II, but made specific suggestions with regard to the general scope and clinical testing sections of the guidance. FDA agreed with the following suggested changes to the special controls guidance and revised the document accordingly:
(1)Determining device-specific T-score thresholds;
(2)removing recommendations regarding monitoring;
(3)increasing the number of women recommended for reproducibility studies;
(4)recommending intermediate-term precision studies in addition to short-term precision studies;
(5)deleting the recommendation that separate T-score thresholds be determined for reference databases based on non-Caucasian females or males of any ethnicity;
(6)recommending justification for exclusion criteria regarding recent use of bone-active drugs;
(7)recommending stratification of patients by bone mineral density rather than age for reproducibility testing;
(8)recommending inclusion of axial dual energy x-ray absorptiometry data in order to determine level of discordance with bone sonometer; and
(9)recommending testing to assess temperature dependence of measurements. The agency disagreed with the suggestion to require that bone sonometers express measurements in terms of fracture risk instead of T-scores. FDA recognizes the diagnostic significance of fracture risk and the limitations of T-scores. Previously-approved bone sonometers, however, express measurements in terms of T-scores because they were developed and approved prior to recent publications reporting limitations of T-scores. Because currently approved bone sonometers express measurements in terms of T-scores, firms wishing to demonstrate substantial equivalence of new bone sonometers with similar indications and technology may choose to express diagnostic measurements in terms of T-scores. The agency distinguishes this goal from that of demonstrating the safety and effectiveness of bone sonometers using new technology, or, with new indications for use, such as fracture risk measurement. As yet, a standardized measure of fracture risk has not been introduced into clinical practice, although FDA is aware that such efforts are currently underway. The agency encourages these efforts. If and when a standard method to predict fracture risk becomes available, FDA may revise the bone sonometers guidance. IV. FDA's Conclusions Based on the information discussed in the preamble to the proposed rule (71 FR 7894), and revisions to the guidance as discussed previously in this document, FDA concludes that special controls, in conjunction with general controls, will provide reasonable assurance of the safety and effectiveness of bone sonometers. The agency is, therefore, reclassifying bone sonometers from class III (premarket approval) into class II (special controls) when intended for determining the possible presence of osteoporosis and/or assessing non-age-related bone loss. Elsewhere in this issue of the **Federal Register** , FDA is announcing the availability of the guidance document entitled “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document; Bone Sonometers” as the special control capable of providing reasonable assurance of safety and effectiveness for these devices. Following the effective date of this final classification rule, any firm submitting a 510(k) premarket notification for a bone sonometer intended for determining the possible presence of osteoporosis and/or assessing non-age-related bone loss will need to address the issues covered in the special controls guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness. FDA is now codifying the classification for bone sonometers by adding new § 892.1180. For the convenience of the reader, 21 CFR 892.1 has been amended to inform the reader where to find guidance documents referenced in 21 CFR part 892. Section 510(m) of the act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device and, therefore, this type of device is not exempt from premarket notification requirements. Persons intending to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the bone sonometer(s) intended for marketing. V. Environmental Impact The agency has determined under 21 CFR 25.34(b) that this reclassification action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. VI. Analysis of Impacts FDA has examined the impacts of the final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety and other advantages; distributive impacts; and equity). The agency certifies that this final rule is not a significant regulatory action as defined by the Executive order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Reclassification of bone sonometers from class III to class II relieves manufacturers of this device type of the costs of complying with the premarket approval requirements in section 515 of the act. Because reclassification will reduce regulatory costs with respect to this device type, it will impose no significant economic impact on any small entities, and it may permit small potential competitors to enter the marketplace by lowering their costs. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $127 million, using the most current
(2006)Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount. VII. Federalism FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. VIII. Paperwork Reduction Act of 1995 This final rule contains no new collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. This final rule also designates a guidance document as a special control. Elsewhere in this issue of the **Federal Register** , FDA is publishing a notice announcing the availability of that guidance document entitled “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers,” which contains a Paperwork Reduction Act analysis for that guidance. List of Subjects in 21 CFR Part 892 Medical devices, Radiation protection, X-rays. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 892 is amended as follows: PART 892—RADIOLOGY DEVICES 1. The authority citation for 21 CFR part 892 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 2. Add § 892.1(e) to read as follows: § 892.1 Scope.
(e)Guidance documents referenced in this part are available on the Internet at *http://www.fda.gov/cdrh/guidance.html* . 3. Add § 892.1180 to subpart B to read as follows: § 892.1180 Bone sonometer.
(a)*Identification* . A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting transducer, a receiving transducer, and hardware and software for reception and processing of the received ultrasonic signal.
(b)*Classification* . Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers.” See § 892.1(e) for the availability of this guidance document. Dated: July 2, 2008. Daniel G. Schultz, Director, Center for Devices and Radiological Health. [FR Doc. E8-16354 Filed 7-16-08; 8:45 am] BILLING CODE 4160-01-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2007-1000; FRL-8691-6] Approval and Promulgation of Air Quality Implementation Plans; Maryland; Amendments to the Control of Volatile Organic Compound Emissions From Portable Fuel Containers AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: EPA is approving a State Implementation Plan
(SIP)revision submitted by the State of Maryland. This revision establishes and requires the control of emissions of volatile organic compounds
(VOCs)portable fuel containers. EPA is approving this SIP revision in accordance with the Clean Air Act (CAA). DATES: *Effective Date:* This final rule is effective on August 18, 2008. ADDRESSES: EPA has established a docket for this action under Docket ID Number EPA-R03-OAR-2007-1000. All documents in the docket are listed on the *http://www.regulations.gov* Web site. Although listed in the electronic docket, some information is not publicly available, i.e., confidential business information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through *http://www.regulations.gov* or in hard copy for public inspection during normal business hours at the Air Protection Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal are available at the Maryland Department of the Environment, 1800 Washington Boulevard, Suite 705, Baltimore, Maryland 21230. FOR FURTHER INFORMATION CONTACT: Gobeail McKinley,
(215)814-2033, or by e-mail at *mckinley.gobeail@epa.gov.* SUPPLEMENTARY INFORMATION: I. Background On December 3, 2007 (72 FR 67878), EPA published a notice of proposed rulemaking
(NPR)for the State of Maryland. The NPR proposed approval of the control of VOC emissions from portable fuel containers. The formal SIP revision was submitted by the Maryland Department of the Environment
(MDE)on June 18, 2007. II. Summary of SIP Revision Maryland's amendments to the portable fuel containers rule incorporate the changes to the 2007 Ozone Transport Commission
(OTC)Model Rule for portable fuel containers that was based on the changes adopted by California Air Resources Board
(CARB)in July 2006. The amendments address the fact that the original rule did not apply to kerosene containers which were offered for sale in place of compliant portable fuel containers. Other amended incorporations include: Modifying the existing spout regulations in order to improve spillage control; elimination of the fuel flow rate and fill level performance standards; elimination of the automatic shutoff performance standard; new containers must be certified for use and sale by the manufacturer through CARB; and, new portable fuel container testing procedures to streamline testing. The amendments, which includes a one-year sell-through period, apply to any person who sells, supplies, advertises or offers for sale, or manufactures for sale portable fuel containers and/or spouts. Owners of portable fuel containers and/or spouts purchased prior to the July 1, 2007 implementation date are not required to purchase or replace the containers and/or spouts with newer, compliant fuel containers. There are no manufacturers of portable fuel containers in Maryland. The rationale for EPA's proposed action are explained in the NPR and will not be restated here. On December 6, 2007, EPA received a comment on its December 3, 2007 NPR. A summary of the comment submitted and EPA's response is provided in section III of this document. III. Summary of Public Comments and EPA Response *Comment:* The commenter expressed a concern that in New Jersey, the container designs are not easy to use, especially for those who use these containers only occasionally, and some people might defeat the designs thereby eliminating any air quality benefits. The commenter asks if EPA would investigate whether the containers will really bring a significant clean air benefit. *Response:* These amendments, submitted by the State of Maryland concerning the control of VOCs from portable fuel containers, are being considered by EPA, on the basis that they strengthen the existing Maryland SIP. There is no comparable Federal rule to reduce VOC emissions from portable fuel containers. The State of Maryland has estimated that these amendments will result in an emission reduction potential of 1.6 tons per day of VOC in the Baltimore nonattainment area, and 6 tons per day of VOC statewide beginning in 2009. 1 The commenter does not dispute that the Maryland portable fuel container rule will reduce VOC emissions, but rather speculates that the emissions reduction features of the fuel containers might be defeated by end-users and asks EPA to investigate whether the rule will achieve “significant clean air benefits.” For purposes of approving this regulation as a SIP-strengthening measure, EPA does not have to determine if the emissions reductions from this regulation are or are not “significant.” EPA merely needs to determine if the rule will generate some additional reductions that would not be achieved by the current Maryland SIP. The commenter does not challenge that at least some amount of reductions will occur due to the implementation of the fuel container rule. 1 Maryland is not at this time requesting EPA to approve a quantified amount of VOC emission reduction from the enactment of its regulation. Rather, this regulation has been submitted by Maryland, and is being considered by EPA, on the basis that it strengthens the existing Maryland SIP. EPA will only review and approve a specific amount of emissions reductions after receiving a proper request to do so from the State of Maryland. Section 110 of the CAA provides the statutory framework for approval/ disapproval of SIP revisions. Under the CAA, EPA establishes NAAQS for certain pollutants. The CAA establishes a joint Federal and State program to control air pollution and protect the public health. States are required to prepare SIPs for each designated “air quality region” within their borders. The SIP must specify emission limits and other measures necessary for that area to meet and maintain the required NAAQS. Each SIP must be submitted to the EPA for its review and approval. EPA will review and must approve the SIP revision if it is found to meet the minimum requirements of the CAA. *See* section 110(k)(3) of the CAA, 42 U.S.C. 7410(k)(3); *see also, Union Elec. Co.* v. *EPA* , 427 U.S. 246, 265, 96 S.Ct. 2518, 49 L.Ed.2d 474 (1976). EPA has concluded that Maryland's amendments concerning the control of VOCs from portable fuel containers meet the minimum criteria for approvability. Furthermore, to the extent that the fuel containers achieve any emissions reductions at all, even reductions that are not “significant,” this SIP revision will be more stringent than the current Maryland SIP. III. Final Action EPA is approving the control of VOC emissions from portable fuel containers (COMAR 26.11.13.07) as a revision to the Maryland SIP which was submitted on June 18, 2007. This regulation will result in the reduction of VOC emissions from the affected sources. IV. Statutory and Executive Order Reviews A. General Requirements Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action: • Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993); • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 *et seq.* ); • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ); • Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4); • Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999); • Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997); • Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); • Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and • Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994). In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law. B. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the **Federal Register.** A major rule cannot take effect until 60 days after it is published in the **Federal Register.** This action is not a “major rule” as defined by 5 U.S.C. 804(2). C. Petitions for Judicial Review Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 15, 2008. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action pertaining to Maryland's amendments to the portable fuel containers rule may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).) List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds. Dated: July 1, 2008. Donald S. Welsh, Regional Administrator, Region III. 40 CFR part 52 is amended as follows: PART 52—[AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 *et seq.* Subpart V—Maryland 2. In § 52.1070, the table in paragraph
(c)is amended by revising the entries for COMAR 26.11.13 [title] and 26.11.13.07 to read as follows: § 52.1070 Identification of plan.
(c)* * * EPA-Approved Regulations in the Maryland SIP Code of Maryland administrative regulations (COMAR) citation Title/subject State effective date EPA approval date Additional explanation/citation at 40 CFR 52.1100 * * * * * * * COMAR 26.11.13 Control of Gasoline and Volatile Organic Compound Storage and Handling * * * * * * * 26.11.13.07 Control of VOC Emissions from Portable Fuel Containers 6/18/07 7/17/08 [Insert page number where the document begins] * * * * * * * [FR Doc. E8-16021 Filed 7-16-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2006-1029; FRL-8689-7] Approval and Promulgation of Air Quality Implementation Plans; Texas; Control of Air Pollution from Volatile Organic Compounds AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: EPA is approving a State Implementation Plan
(SIP)revision submitted by the State of Texas. This revision, adopted by Texas on November 15, 2006, and submitted to EPA on December 13, 2006, extends requirements to reduce volatile organic compound
(VOC)emissions in the Dallas-Fort Worth
(DFW)area. Specifically, this revision extends requirements for control of VOC emissions to the five counties that were added to the DFW nonattainment area under the 1997 8-hour ozone standard designation: Ellis, Johnson, Kaufman, Parker, and Rockwall, and the affected VOC sources will be subject to the same emission limitation, control, monitoring, testing, recordkeeping, and recording requirements already in effect in Collin, Dallas, Denton, and Tarrant counties. As a result of this action, these new VOC control requirements will be consistent for all nine counties in the DFW ozone nonattainment area. This revision meets statutory and regulatory requirements, and is consistent with EPA's guidance. EPA is approving this revision pursuant to section 110, 116 and part D of the Federal Clean Air Act (CAA). DATES: This direct final rule will be effective September 15, 2008 without further notice, unless EPA receives relevant adverse comments by August 18, 2008. If EPA receives such comment, EPA will publish a timely withdrawal of the direct final rule in the **Federal Register** informing the public that this rule will not take effect. ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-2006-1029, by one of the following methods: • *Federal eRulemaking Portal: http://www.regulations.gov.* Follow the on-line instructions for submitting comments. • *EPA Region 6 “Contact Us” Web site: http://epa.gov/region6/r6coment.htm.* Please click on “6PD” (Multimedia) and select “Air” before submitting comments. • *E-mail:* Mr. Guy Donaldson at *donaldson.guy@epa.gov.* Please also send a copy by email to the person listed in the FOR FURTHER INFORMATION CONTACT section below. • *Fax:* Mr. Guy Donaldson, Chief, Air Planning Section (6PD-L), at fax number 214-665-7263. • *Mail:* Mr. Guy Donaldson, Chief, Air Planning Section (6PD-L), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202-2733. • *Hand or Courier Delivery:* Mr. Guy Donaldson, Chief, Air Planning Section (6PD-L), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202-2733. Such deliveries are accepted only between the hours of 8 a.m. and 4 p.m. weekdays except for legal holidays. Special arrangements should be made for deliveries of boxed information. *Instructions:* Direct your comments to Docket ID No. EPA-R06-OAR-2006-1029. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *http://www.regulations.gov* or e-mail. The *http://www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *http://www.regulations.go* v your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket:* All documents in the docket are listed in the *http://www.regulations.gov* index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *http://www.regulations.gov* or in hard copy at the Air Planning Section (6PD-L), Environmental Protection Agency, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733. The file will be made available by appointment for public inspection in the Region 6 FOIA Review Room between the hours of 8:30 a.m. and 4:30 p.m. weekdays except for legal holidays. Contact the person listed in the FOR FURTHER INFORMATION CONTACT paragraph below or Mr. Bill Deese at 214-665-7253 to make an appointment. If possible, please make the appointment at least two working days in advance of your visit. There will be a 15 cent per page fee for making photocopies of documents. On the day of the visit, please check in at the EPA Region 6 reception area at 1445 Ross Avenue, Suite 700, Dallas, Texas. The State submittal is also available for public inspection at the State Air Agency listed below during official business hours by appointment: Texas Commission on Environmental Quality, Office of Air Quality, 12124 Park 35 Circle, Austin, Texas 78753. FOR FURTHER INFORMATION CONTACT: Ellen Belk, Air Planning Section (6PD-L), Environmental Protection Agency, Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733, telephone
(214)665-2164; fax number 214-665-7263; e-mail address *belk.ellen@epa.gov.* SUPPLEMENTARY INFORMATION I. General Information Throughout this document, whenever “we”, “us” or “our” is used, we mean the EPA. II. Rulemaking Information This section is organized as follows: A. What Action Is EPA Taking? B. What Are the Requirements of Texas' New Regulation? C. Why Is EPA Approving Texas' Regulation? D. What Is the Process for EPA to Approve This SIP Revision? A. What Action Is EPA Taking? EPA is approving Texas' Chapter 115 “Control of Air Pollution from Volatile Organic Compounds” amendments to §§ 115.10, 115.119, 115.129, 115.139, 115.149, 115.219, 115.239, 115.319, 115.359, 115.419, 115.439, 115.449, 115.519, and 115.539 which subject VOC-emitting sources located in Ellis, Johnson, Kaufman, Parker, and Rockwall Counties to the same emission limitation, control, monitoring, testing, recordkeeping, and recording requirements in effect in Collin, Dallas, Denton, and Tarrant Counties, the other four counties in the DFW 8-hour ozone nonattainment area. The revisions were adopted by Texas on November 15, 2006, and submitted to EPA on December 13, 2006. B. What Are the Requirements of Texas' New Regulation? The DFW area is classified as a moderate nonattainment area for the 1997 8-hour ozone standard. This rule will affect VOC-emitting facilities in five counties of the DFW 8-hour ozone nonattainment area. Table 1 lists the affected Texas Counties: Table 1.—Counties Affected by This Rulemaking Counties in DFW 8-hour ozone nonattainment area affected by this rulemaking Ellis Johnson Kaufman Parker Rockwall Texas' Chapter 115 regulations control VOC emissions for many categories of sources. In particular, this rulemaking affects the TAC Subchapters and Divisions listed in Table 2: Table 2.—Texas Administrative Code
(TAC)Chapter 115 Subchapters Affected by This Rulemaking Chapter 115 subchapter Section A Definitions 115.10 B General VOC Sources Division 1 Storage of VOCs 115.119 Division 2 Vent Gas Control 115.129 Division 3 Water Separation 115.139 Division 4 Industrial Wastewater 115.149 C VOC Transfer Operations Division 1 Loading and Unloading of VOCs 115.219 Division 3 Control of VOC Leaks from Transport Vessels 115.239 D Petroleum Refining, Natural Gas Processing, and Petrochemical Processes Division 1 Process Unit Turnaround and Vacuum-Producing Systems in Petroleum Refineries 115.319 Division 3 Fugitive Emission Control in Petroleum Refining, Natural Gas/Gasoline Processing, and Petrochemical Processes in Ozone Nonattainment Areas 115.359 E Solvent-Using Processes Division 1 Degreasing Processes 115.419 Division 3 Flexographic and Rotogravure Printing 115.439 Division 4 Offset Lithographic Printing 115.449 F Miscellaneous Industrial Sources Division 1 Cutback Asphalt 115.519 Division 2 Pharmaceutical Manufacturing Facilities 115.539 To determine whether a specific facility in one of the above counties will be affected by one or more of the above revisions, see Texas' associated rule revisions included in the docket. This rule requires compliance with the specified VOC control requirements by March 1, 2009. C. Why Is EPA Approving Texas' Revisions? On May 23, 2007, the Texas Commission on Environmental Quality (TCEQ or Texas) approved revisions to the SIP for the DFW 8-hour ozone nonattainment area. The SIP revisions were submitted to EPA on May 30, 2007. Extending requirements for control of VOC emissions to the additional counties will help to attain and maintain the 8-hour ozone standard in the DFW area. Our approval of the revised Texas regulations will make them federally enforceable. EPA is evaluating Texas' analysis for Reasonable Available Control Technology
(RACT)for NO <sup>X</sup> and VOC in actions which are separate from this one. EPA has evaluated the Chapter 115 revisions and finds they enhance the SIP by extending existing VOC control requirements to additional counties. The specific requirements for the regulation and EPA's evaluation of these requirements are detailed in the Technical Support Document (TSD), which is available in the docket supporting this action. Also, Texas' Chapter 115 revisions are included in the docket. D. What Is the Process for EPA to Approve This SIP Revision? The EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. However, in the proposed rules section of this **Federal Register** publication, EPA is publishing a separate documents that will serve as the proposal to approve the SIP revision should adverse comments be filed. This action will be effective September 15, 2008 without further notice, unless EPA receives relevant adverse comments by August 18, 2008. If EPA receives such comment, EPA will publish a timely withdrawal of the direct final rule in the **Federal Register** informing the public that this rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on September 15, 2008 and no further action will be taken on the proposed rule. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. III. Final Action EPA is approving Texas' Chapter 115 Control of Air Pollution from Volatile Organic Compounds amendments to §§ 115.10, 115.119, 115.129, 115.139, 115.149, 115.219, 115.239, 115.319, 115.359, 115.419, 115.439, 115.449, 115.519, and 115.539 which extend requirements for control of VOC emissions to sources located in Ellis, Johnson, Kaufman, Parker, and Rockwall Counties, and incorporating this regulation into the Texas SIP. IV. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant. Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal executive policy on environmental justice. Because this rule merely proposes to approve a state rule implementing a Federal standard, EPA lacks the discretionary authority to modify today's regulatory decision on the basis of environmental justice considerations. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the CAA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq* .). The Congressional Review Act, 5 U.S.C. section 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the **Federal Register** . A major rule cannot take effect until 60 days after it is published in the **Federal Register** . This action is not a “major rule” as defined by 5 U.S.C. section 804(2). Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit September 15, 2008. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).) List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Nitrogen dioxides, Reporting and recordkeeping requirements, Volatile organic compounds. Dated: July 1, 2008. Richard E. Greene, Regional Administrator, Region 6. 40 CFR part 52 is amended as follows: PART 52—[AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 *et seq.* Subpart SS—Texas 2. The table in § 52.2270(c) entitled “EPA Approved Regulations in the Texas SIP” is amended under Chapter 115 (Reg 5)—Control of Air Pollution from Volatile Organic Compounds by: a. Revising the entries for Sections 115.10, 115.119, 115.129, 115.139, 115.149, 115.219, 115.239, 115.319, 115.359, 115.419, 115.439, 115.449, 115.519, and 115.539; b. Revising the title of Division 3 under Subchapter B to read “Division 3: Water Separation”. The revisions read as follows: § 52.2270 Identification of plan.
(c)* * * EPA-Approved Regulations in the Texas SIP State citation Title/subject State approval/submittal date EPA approval date Explanation * * * * * * * Chapter 115 (Reg 5)—Control of Air Pollution From Volatile Organic Compounds Subchapter A—Definitions Section 115.10 Definitions 11/15/06 07/17/08 [Insert FR page number where document begins] Subchapter B—General Volatile Organic Compound Sources Division 1: Storage of Volatile Organic Compounds * * * * * * * Section 115.119 Counties and Compliance Schedules 11/15/06 07/17/08 [Insert FR page number where document begins] Division 2: Vent Gas Control * * * * * * * Section 115.129 Counties and Compliance Schedules 11/15/06 07/17/08 [Insert FR page number where document begins] Division 3: Water Separation * * * * * * * Section 115.139 Counties and Compliance Schedules 11/15/06 07/17/08 [Insert FR page number where document begins] Division 4: Industrial Wastewater * * * * * * * Section 115.149 Counties and Compliance Schedules 11/15/06 07/17/08 [Insert FR page number where document begins] * * * * * * * Subchapter C—Volatile Organic Compound Transfer Operations Division 1: Loading and Unloading of Volatile Organic Compounds * * * * * * * Section 115.219 Counties and Compliance Schedules 11/15/06 07/17/08 [Insert FR page number where document begins] * * * * * * * Division 3: Control of Volatile Organic Compound Leaks From Transport Vessels * * * * * * * Section 115.239 Counties and Compliance Schedules 11/15/06 07/17/08 [Insert FR page number where document begins] * * * * * * * Subchapter D—Petroleum Refining, Natural Gas Processing, and Petrochemical Processes Division 1: Process Unit Turnaround and Vacuum-Producing Systems in Petroleum Refineries * * * * * * * Section 115.319 Counties and Compliance Schedules 11/15/06 07/17/08 [Insert FR page number where document begins] * * * * * * * Division 3: Fugitive Emission Control in Petroleum Refining, Natural Gas/Gasoline Processing, and Petrochemical Processes in Ozone Nonattainment Areas * * * * * * * Section 115.359 Counties and Compliance Schedules 11/15/06 07/17/08 [Insert FR page number where document begins] Subchapter E—Solvent-Using Processes Division 1: Degreasing Processes * * * * * * * Section 115.419 Counties and Compliance Schedules 11/15/06 07/17/08 [Insert FR page number where document begins] * * * * * * * Division 3: Flexographic and Rotogravure Printing * * * * * * * Section 115.439 Counties and Compliance Schedules 11/15/06 07/17/08 [Insert FR page number where document begins] Division 4: Offset Lithographic Printing * * * * * * * Section 115.449 Counties and Compliance Schedules 11/15/06 07/17/08 [Insert FR page number where document begins] Subchapter F—Miscellaneous Industrial Sources Division 1: Cutback Asphalt * * * * * * * Section 115.519 Counties and Compliance Schedules 11/15/06 07/17/08 [Insert FR page number where document begins] Division 2: Pharmaceutical Manufacturing Facilities * * * * * * * Section 115.539 Counties and Compliance Schedules 11/15/06 07/17/08 [Insert FR page number where document begins] * * * * * * * [FR Doc. E8-15729 Filed 7-16-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 63 [EPA-HQ-OAR-2003-0138; FRL-8693-9] RIN 2060-AO99 National Emission Standards for Hazardous Air Pollutants: Organic Liquids Distribution (Non-Gasoline) AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule; partial withdrawal of direct final rule; amendments. SUMMARY: EPA published proposed and direct final rule amendments on April 23, 2008, of the national emission standards for hazardous air pollutants for organic liquids distribution (non-gasoline), which EPA promulgated on February 3, 2004, and amended on July 28, 2006. Because adverse comments were received on two of the April 23, 2008, proposed and direct final rule amendments, EPA is withdrawing the two corresponding regulatory amendments in the direct final rule before they become effective on July 22, 2008. The other regulatory amendments discussed in the direct final rule, for which we did not receive any adverse comments, will become effective on July 22, 2008, as we stated in that notice. In addition, in this action EPA is promulgating final rule amendments regarding the provisions that were commented upon and withdrawn, and responds to the adverse comments we received. Additionally we are correcting typographical errors that we have identified in other sections of the rule text that were not addressed in the April 23, 2008, notices. DATES: As of July 17, 2008, EPA withdraws the direct final rule revision for 40 CFR 63.2358(b)(1) and (c)(1), and Table 10 to Subpart EEEE of Part 63 entries 4. and 6., published on April 23, 2008 (79 FR 21825). The final rule amendments in this action are effective on July 17, 2008. ADDRESSES: EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2003-0138. All documents in the docket are listed on the *http://www.regulations.gov* Web site. Although listed in the index, some information is not publicly available, e.g., confidential business information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *http://www.regulations.gov* or in hard copy at the Air and Radiation Docket, EPA West Building, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is
(202)566-1744, and the telephone number for the Air and Radiation Docket is
(202)566-1742. FOR FURTHER INFORMATION CONTACT: *General and Technical Information:* Mr. Stephen Shedd, Office of Air Quality Planning and Standards, Sector Policies and Programs Division, Coatings and Chemicals Group (E143-01), EPA, Research Triangle Park, NC 27711, *telephone:*
(919)541-5397, *facsimile number:*
(919)685-3195, *e-mail address: shedd.steve@epa.gov.* *Compliance Information:* Ms. Marcia Mia, Office of Compliance, Air Compliance Branch (2223A), EPA, Ariel Rios Building, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, *telephone:*
(202)564-7042, *facsimile number:*
(202)564-0050, *e-mail address: mia.marcia@epa.gov.* SUPPLEMENTARY INFORMATION: *Outline:* The information presented in this preamble is organized as follows: I. General Information II. Background III. What action is EPA taking? IV. Withdrawal of Two Direct Final Rule Amendments V. Rationale for These Final Rule Amendments A. Storage Tank Compliance Date B. Monitoring of Storage Tank Pressure Relief Devices C. Typographical Errors VI. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer and Advancement Act J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations K. Congressional Review Act I. General Information A. Does this action apply to me? Categories and entities potentially regulated by this action include: Category NAICS* code Examples of regulated entities Industry 325211, 325192, 325188, 32411, 49311, 49319, 48611, 42269, 42271 Operations at major sources that transfer organic liquids into or out of the plant site, including: liquid storage terminals, crude oil pipeline stations, petroleum refineries, chemical manufacturing facilities, and other manufacturing facilities with collocated OLD operations. Federal Government Federal agency facilities that operate any of the types of entities listed under the “industry” category in this table. * North American Industry Classification System/Considered to be the primary industrial codes for the plant sites with OLD operations. This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this final rule. To determine whether your facility is regulated by this action, you should examine the applicability criteria in 40 CFR part 63, subpart EEEE. If you have any questions regarding the applicability of this final rule to a particular entity, consult either the air permit authority for the entity or your EPA regional representative as listed in 40 CFR 63.13. B. Where can I get a copy of this document? In addition to being available in the docket, an electronic copy of this final rule is also available on the Worldwide Web through the Technology Transfer Network (TTN). Following signature, a copy of this final rule will be posted on the TTN's policy and guidance page for newly proposed or promulgated rules at the following address: *http://www.epa.gov/ttn/oarpg.* The TTN provides information and technology exchange in various areas of air pollution control. C. Judicial Review Under section 307(b)(1) of the Clean Air Act (CAA), judicial review of this final rule is available only by filing a petition for review in the United States Court of Appeals for the District of Columbia Circuit by September 15, 2008. Under section 307(b)(2) of the CAA, the requirements established by this final rule may not be challenged separately in any civil or criminal proceedings brought by EPA to enforce these requirements. Section 307(d)(7)(B) of the CAA further provides that “[o]nly an objection to a rule or procedure which was raised with reasonable specificity during the period for public comment (including any public hearing) may be raised during judicial review.” This section also provides a mechanism for us to convene a proceeding for reconsideration, “[i]f the person raising an objection can demonstrate to the Administrator that it was impracticable to raise such objection within [the period for public comment] or if the grounds for such objection arose after the period for public comment (but within the time specified for judicial review) and if such objection is of central relevance to the outcome of the rule.” Any person seeking to make such a demonstration to us should submit a Petition for Reconsideration to the Office of the Administrator, U.S. EPA, Room 3000, Ariel Rios Building, 1200 Pennsylvania Ave., NW., Washington, DC 20460, with a copy to both the persons(s) listed in the preceding FOR FURTHER INFORMATION CONTACT section, and the Associate General Counsel for the Air and Radiation Law Office, Office of General Counsel (Mail Code 2344A), U.S. EPA, 1200 Pennsylvania Ave., NW., Washington, DC 20460. II. Background On February 3, 2004 (69 FR 5063), EPA promulgated the National Emission Standards for Hazardous Air Pollutants: Organic Liquids Distribution (Non-Gasoline) (OLD NESHAP) (40 CFR part 63, subpart EEEE) pursuant to section 112 of the CAA. In response to several petitions for administrative reconsideration of the OLD NESHAP and several petitions for judicial review filed with the United States Court of Appeals for the District of Columbia Circuit, and pursuant to a settlement agreement between some of the parties to the litigation, EPA proposed amendments to subpart EEEE on November 14, 2005 (70 FR 69210). On July 28, 2006 (71 FR 42898), EPA promulgated amendments to subpart EEEE based on consideration of the comments received on the proposed amendments. On April 23, 2008 (79 FR 21825 and 21889, respectively), we published a direct final rule and parallel proposed amendments to clarify combustion control device compliance requirements, certain storage tank control compliance dates, and vapor balance system monitoring requirements. In addition, we corrected several rule text format, grammatical, and typographical errors. III. What action is EPA taking? In summary, under this action, we are withdrawing two of the amendments we proposed through direct final action on April 23, 2008. Also, under this action, we are promulgating final amendments to respond to the adverse comments we received regarding the regulatory provisions addressed by those comments. Additionally, we are correcting typographical errors found in the rule text, which were not discussed in the April 23, 2008, direct final rule and proposed amendments but have subsequently been identified. IV. Withdrawal of Two Direct Final Rule Amendments In the April 23, 2008, direct final rule we said that if we received adverse comments, we would publish a timely withdraw in the **Federal Register** informing the public that this rule, or the relevant section of this rule, will not take effect. We also stated that the provisions that are not withdrawn would become effective on July 22, 2008, notwithstanding adverse comment on any other provision, unless we determined that it would not be appropriate to promulgate those provisions due to their possibly being affected by the adverse comments (73 FR at 21825-26). We have determined that the comments we received affect only the specific regulatory amendments that were addressed by those comments, and not the other provisions in the direct final amendments. Accordingly, we are withdrawing only the amendments on which we received adverse comments. Before the comment period for the April 23, 2008, direct final rule and parallel proposal ended on June 9, 2008, we received one comment letter from industry objecting to how we presented the amended rule text for compliance dates for storage tanks in § 63.2358(b)(1) and (c)(1), and the pressure relief device compliance provisions in items 4. and 6. of Table 10 to Subpart EEEE of Part 63—Continuous Compliance with Work Practice Standards. Therefore, we are withdrawing those amendments. However, the amendments to regulatory provisions in the direct final rule for which we did not receive adverse comment will become effective on July 22, 2008. Also, as discussed below we are addressing the adverse comments received on the direct final rule and amending the corresponding provisions that were reflected in the direct final rule; these amendments are effective as of today. As stated in the parallel proposal, we will not institute a second comment period on this action. V. Rationale for These Final Rule Amendments A. Storage Tank Compliance Date As discussed in the April 23, 2008, direct final rule, we had intended that existing source storage tanks with floating roofs must comply with the rim seal requirements at the next degassing and cleaning activity or within 10 years after February 3, 2004 (by February 3, 2014), whichever occurs first, instead of requiring compliance within 3 years, as was required for other sources of emissions. However, the rule text of § 63.2358(c)(1) for work practice standards in Table 4 incorrectly provided that all existing source storage tanks (floating and fixed roof) must comply no later than 10 years after February 3, 2004. Therefore, in the April 23, 2008, direct final rule and parallel proposal, we would have amended the rule to implement our intent that the allowance for “not later than 10 years after February 3, 2004” apply to floating roof storage tanks only. Additionally, in the April 23, 2008, direct final rule and parallel proposal we would have given fixed roof tanks 3 years (by April 25, 2011) to comply with the work practice standards since they need time to plan and install control equipment. We received a comment in which the commenter agreed with EPA's intent to clarify the initial compliance date for existing source storage tanks; however, the commenter said that the proposed language in § 63.2358(b)(1) and (c)(1) does not clearly capture those requirements. The commenter also provided suggested rule text changes. We have considered the commenter's suggested revisions and agree with the commenter that the revision to § 63.2358(b)(1) in the April 23, 2008, direct final rule did not adequately accomplish our intent in revising the rule. Therefore, with some modifications, we have incorporated the commenter's approach for clarifying the initial compliance demonstration dates. We also agree with the suggestion to clarify the rule by providing separate paragraphs
(i)and
(ii)under § 63.2358(c)(1) to address floating roof storage tanks separately from storage tanks without floating roofs. In addition, we have decided that the requirements would be more clearly stated if we split the initial compliance dates for emission limits in Table 2, as specified in § 63.2358(b)(1), into two separate paragraphs. The commenter thought that the existing rule text was correct instead of the proposed text, but we believe neither the proposed nor existing rule text is correct. As currently worded, section (b)(1) requires the initial compliance demonstration for storage tanks and transfer racks at existing affected sources complying with the emission limitations listed in Table 2 to be conducted within 180 days after February 5, 2007. We do not wish to change this initial compliance demonstration date for transfer racks or for storage tanks that are complying with the 95 percent emission reduction requirement of Table 2, item a.i. However, we are changing the initial compliance demonstration date for storage tanks that are complying with the other requirements of Table 2 that are cross-referenced to the work practice standards in Table 4. We are adding paragraph (b)(1)(i) to clearly specify that storage tanks with an existing internal or external floating roof, complying with the rim seal requirements (item 1.a.ii. in Table 2 and item 1.a. in Table 4) must conduct the initial compliance demonstration the next time the storage tank is emptied and degassed, but not later than February 3, 2014. We are adding paragraph (b)(1)(ii) to specify that storage tanks complying with the other work practice standards (item 1.a.ii. or 6.a.ii in Table 2 and items 1.b., 1.c., or 2. in Table 4) must comply within 180 days after April 25, 2011. B. Monitoring of Storage Tank Pressure Relief Devices In the April 23, 2008, direct final rule and parallel proposal, we intended to clarify how to monitor pressure relief devices for transfer racks and storage tanks under the vapor balancing and equipment leak provisions (§ 63.2346(a)(4)(v) and in Table 10 to Subpart EEEE of Part 63—Continuous Compliance with Work Practice Standards, respectively). We received a comment stating that in the April 23, 2008, amendments the revised Table 10, item 4.b.i. incorrectly specifies that transfer rack vapor balance systems use the pressure relief device specification in § 63.2346(a)(4)(v). The commenter stated that this quarterly pressure relief device specification only applies to pressure relief devices associated with storage tanks using the vapor balancing option and that adding this clarification for transfer racks to item 4.b.i. creates another requirement that was not initially specified. As discussed in the preamble to the April 23, 2008, direct final rule, our intent in revising Table 10 was to respond to questions concerning the relationship between the vapor balance system monitoring requirements for pressure relief devices in the rule text (§ 63.2346(a)(4)(v)) and those in Table 10 (item 6.b.i.). Given that both Table 10 and the rule text of § 63.2346 contained requirements for the monitoring of vapor balance systems, we made parallel clarifications to the storage tank and loading rack provisions. The commenter correctly points out, however, that the pressure relief requirements of § 63.2346(a)(4)(v) apply only to storage tanks and not to transfer racks. Upon review of the existing cross-referenced requirement for transfer racks, we found that Table 10 (item 4.b.i.) already requires that the owner or operator implement monitoring requirements under either 40 CFR 63 subparts TT, UU, or H, similar to those already in this rule for storage tanks. Given the similar requirements, there is no need to add the transfer rack vapor balance provisions for pressure relief devices. Thus, in this final action we are not including amendments for monitoring pressure relief devices for transfer racks in item 4 of Table 10. The commenter also pointed out that the last sentence added to the monitoring requirements for storage tank vapor balance systems (item 6.b.i. of Table 10) incorrectly includes requirements for loading of a transport vehicle and filling of a container, instead of a storage tank. We agree and have now reworded the sentence only to include storage tanks as follows: “If no loading of a storage tank occurs during a quarter, then monitoring of the vapor balancing system is not required.” Thus, with that modification, we are finalizing the amendments to pressure relief devices and monitoring of vapor balance systems for storage tanks (item 6.b.i. in Table 10) discussed in the direct final rule. C. Typographical Errors When analyzing the two adverse comments, we found a typographical error in § 63.2346(a)(4)(v) that incorrectly refers to § 63.2346(a)(4)(iv)(A) through (C), instead of § 63.2346(a)(4)(v)(A) through (C). Additionally, a state agency representative pointed out a second typographical error in § 63.2390(e)(2), (3), and (3)(ii) that incorrectly refers to § 63.2348(a)(4)(v), (a)(4)(vi)(B), and (a)(4)(vi)(B), respectively, instead of § 63.2346(a)(4)(v), (a)(4)(vi)(B), and (a)(4)(vi)(B). All the typographical errors were found in existing rule text that was not addressed in the notices published on April 23, 2008. We are making those corrections in this final rule. These corrections to typographical errors do not affect the substance of the rule, nor do they change the rights or obligations of any party. Rather, this action merely corrects certain technical errors in the references in the rule. Thus, it is proper to issue these corrections to the rule without notice and comment. Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. We have determined that there is good cause for making this action final without prior proposal and opportunity for comment because the changes to the rule are minor technical corrections, are noncontroversial, and do not substantively change the agency actions taken in today's final rule. Thus, notice and public procedure are unnecessary. We find that this constitutes good cause under 5 U.S.C. 553(b)(B). VI. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under the Executive Order. B. Paperwork Reduction Act This action does not impose any new information collection burden. The final amendments clarify, but do not add requirements increasing the collection burden. However, the Office of Management and Budget
(OMB)has previously approved the information collection requirements contained in the existing regulations at 40 CFR part 63, subpart EEEE under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501, *et seq.* , and has assigned OMB control number 2060-0539. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9. C. Regulatory Flexibility Act The Regulatory Flexibility Act
(RFA)generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the APA or any other statute unless the Agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of this rule on small entities, a small entity is defined as:
(1)A small business as defined by the Small Business Administration's
(SBA)regulations at 13 CFR 121.201;
(2)a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; or
(3)a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. After considering the economic impacts of this final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. These final rule amendments will not impose any new requirements on small entities, since we are clarifying rule text. D. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires us to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows us to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before we establish any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, we must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements. This final rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local, or tribal governments or the private sector. These final rule amendments clarify certain provisions and correct typographical errors in the rule text for a rule EPA determined not to include a Federal mandate that may result in an estimated cost of $100 million or more (69 FR 5061, February 3, 2004). These clarifications do not change the level or cost of the standard. Thus, this final rule is not subject to the requirements of sections 202 and 205 of the UMRA. EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. These final rule amendments clarify certain provisions and correct typographical errors in the rule text, thus, should not affect small governments. E. Executive Order 13132: Federalism Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. The amendments provide clarification and correct typographical errors. These changes do not modify existing or create new responsibilities among EPA Regional Offices, States, or local enforcement agencies. Thus, Executive Order 13132 does not apply to this final rule. F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This final rule does not have tribal implications, as specified in Executive Order 13175. The amendments will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Thus, Executive Order 13175 does not apply to this rule. G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This action is not subject to Executive Order 13045 because it is based solely on technology performance. H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866. I. National Technology Transfer and Advancement Act Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards
(VCS)in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. VCS are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by VCS bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable VCS. This action does not involve technical standards. Therefore, EPA did not consider the use of any VCS. J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations Executive Order 12898 (59 FR 7629, February 16, 1994) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. These final rule amendments do not relax the control measures on sources regulated by the rule and, therefore, will not cause emissions increases from these sources. K. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801, *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing the final rule amendments and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the United States prior to publication of the final rule amendments in the **Federal Register** . A major rule cannot take effect until 60 days after it is published in the **Federal Register** . This action is not a “major rule” as defined by 5 U.S.C. 804(2). These final rule amendments will be effective on July 17, 2008. List of Subjects in 40 CFR Part 63 Environmental protection, Administrative practice and procedure, Air pollution control, Hazardous substances, Intergovernmental relations, Reporting and recordkeeping requirements. Dated: July 10, 2008. Stephen L. Johnson, Administrator. For the reasons set out in the preamble, title 40, chapter I, part 63 of the Code of Federal Regulations is amended as follows: PART 63—[AMENDED] 1. The authority citation for part 63 continues to read as follows: Authority: 42 U.S.C. 7401, *et seq* . Subpart EEEE—[Amended] 2. The amendments to § 63.2358(b)(1) and (c)(1), and to entries 4. and 6. of TABLE 10 TO SUBPART EEEE OF PART 63-CONTINUOUS COMPLIANCE WITH WORK PRACTICE STANDARDS published on April 23, 2008 (79 FR 21825) are withdrawn as of July 17, 2008. § 63.2346 [Amended] 3. Section 63.2346 is amended in paragraph (a)(4)(v) introductory text by removing the citation “(a)(4)(iv)(A) through (C)” and adding in its place the citation “(a)(4)(v)(A) through (C)”. 4. Section 63.2358 is amended by revising paragraphs (b)(1) and (c)(1) to read as follows: § 63.2358 By what date must I conduct performance tests and other initial compliance demonstrations? (b)(1) For storage tanks and transfer racks at existing affected sources complying with the emission limitations listed in Table 2 to this subpart, you must demonstrate initial compliance with the emission limitations within 180 days after February 5, 2007, except as provided in paragraphs (b)(1)(i) and (b)(1)(ii) of this section.
(i)For storage tanks with an existing internal or external floating roof, complying with item 1.a.ii. in Table 2 to this subpart and item 1.a. in Table 4 to this subpart, you must conduct your initial compliance demonstration the next time the storage tank is emptied and degassed, but not later than February 3, 2014.
(ii)For storage tanks complying with item 1.a.ii. or 6.a.ii in Table 2 of this subpart and item 1.b., 1.c., or 2. in Table 4 of this subpart, you must comply within 180 days after April 25, 2011. (c)(1) For storage tanks at existing affected sources complying with the work practice standard in Table 4 to this subpart, you must conduct your initial compliance demonstration as specified in paragraphs (c)(1)(i) and (c)(1)(ii) of this section.
(i)For storage tanks with an existing internal or external floating roof, complying with item 1.a. in Table 4 of this subpart, you must conduct your initial compliance demonstration the next time the storage tank is emptied and degassed, but not later than February 3, 2014.
(ii)For other storage tanks not specified in paragraph (c)(1)(i) of this section, you must comply within 180 days after April 25, 2011. § 63.2390 [Amended] 5. Section 63.2390 is amended as follows: a. In paragraph (e)(2) by removing the citation “§ 63.2348(a)(4)(v)” and adding in its place the citation “§ 63.2346(a)(4)(v)”. b. In paragraph (e)(3) by removing the citation “§ 63.2348(a)(4)(vi)(B)” and adding in its place the citation “§ 63.2346(a)(4)(vi)(B)”. c. In paragraph (e)(3)(ii) by removing the citation “§ 63.2348(a)(4)(vi)(B)” and adding in its place the citation “§ 63.2346(a)(4)(vi)(B)”. 6. Table 10 to Subpart EEEE of Part 63 is amended by revising entry 6. to read as follows: Table 10 to Subpart EEEE of Part 63.—Continuous Compliance With Work Practice Standards * * * * * * * For each . . . For the following standard . . . You must demonstrate continuous compliance by . . . * * * * * * * 6. Storage tank at an existing, reconstructed, or new affected source meeting any of the tank capacity and vapor pressure criteria specified in Table 2 to this subpart, items 1 through 6. a. Route emissions to a fuel gas system or back to the process. i. Continuing to meet the requirements specified in § 63.984(b). b. Install and, during the filling of the storage tank with organic liquids, operate a vapor balancing system. i. Except for pressure relief devices, monitoring each potential source of vapor leakage in the system, including, but not limited to pumps, valves, and sampling connections, quarterly during the loading of a storage tank using the methods and procedures described in the rule requirements selected for the work practice standard for equipment leak components as specified in Table 4 to this subpart, item 4. An instrument reading of 500 ppmv defines a leak. Repair of leaks is performed according to the repair requirements specified in your selected equipment leak standards. For pressure relief devices, comply with § 63.2346(a)(4)(v). If no loading of a storage tank occurs during a quarter, then monitoring of the vapor balancing system is not required. [FR Doc. E8-16320 Filed 7-16-08; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 42 CFR Part 1008 Office of Inspector General; Medicare and State Health Care Programs: Fraud and Abuse; Issuance of Advisory Opinions by the OIG AGENCY: Office of Inspector General (OIG), HHS. ACTION: Final rule. SUMMARY: OIG is adopting in final form, without change, an interim final rule published on March 26, 2008 (73 FR 15937). We received no comments to the interim final rule. The interim final rule revised the process for advisory opinion requestors to submit payments for advisory opinion costs. DATES: *Effective Date:* This final rule is effective as of July 17, 2008. FOR FURTHER INFORMATION CONTACT: Meredith Melmed, Office of Counsel to the Inspector General,
(202)619-0335. SUPPLEMENTARY INFORMATION: I. Background The Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-101, specifically required the Department of Health and Human Services (Department) to provide a formal guidance process to requesting individuals and entities regarding the application of the anti-kickback statute, the safe harbor provisions, and other OIG health care fraud and abuse sanctions. OIG published an interim final rule (62 FR 7350; February 19, 1997) establishing a new part 1008 in 42 CFR chapter V addressing various procedural issues and aspects of the advisory opinion process. In response to public comments received on the interim final regulations, we published a final rule (63 FR 38311; July 16, 1998) revising and clarifying various aspects of the earlier rulemaking. The rulemaking established procedures for requesting an advisory opinion. Specifically, the rule provided information to the public regarding costs associated with preparing an opinion and procedures for submitting an initial deposit and final payment to OIG for such costs. II. Interim Final Rule With Comment Period and Final Rule On March 26, 2008, OIG published an interim final rule amending 42 CFR chapter V, subchapter B (73 FR 15937). The comment period ended on April 25, 2008 and no comments were received. Accordingly, OIG is adopting the interim final rule as a final rule with no modifications. The interim final rule modified the procedures for submitting an advisory opinion request by deleting the requirements at § 1008.31(b) and 1008.36(b)(6) for an initial payment of $250 for each advisory opinion request, and amending § 1008.31(b) to require that payment for an advisory opinion be made directly to the Treasury of the United States, as directed by OIG. In addition, we amended § 1008.43(d) to state that an advisory opinion will be issued following receipt by OIG of confirmation that payment in full has been remitted by the requesting party to the Department of Treasury, as directed by OIG. We also notified the public that, as of the effective date of the interim final rule, we no longer would accept checks or money orders from requesting parties and payments must be made directly to the United States Treasury through wire or other electronic funds transfer. We provided additional instructions to the public on our Web site ( *www.oig.hhs.gov* ) for paying fees owed for advisory opinions via wire or other electronic funds transfer. III. Regulatory Impact Statement A. Administrative Procedure Act The advisory opinion process is an established OIG program. This final rule is limited to modifying the processing of payments received for advisory opinion requests. It does not modify eligibility of a party to request an advisory opinion, nor does it modify the standards under which OIG will accept and/or analyze a request. OIG expects that this final rule will further the public's interest with minimal burden by confirming the interim final rule, which deleted the requirement for an initial payment of a deposit to be credited toward the final advisory opinion processing costs, and by requiring the use of electronic transfers of funds. This final rule will also provide greater efficiency in processing payments from requestors and will save staff time. B. Regulatory Analysis We have examined the impact of this final rule as required by Executive Order 12866, the Regulatory Flexibility Act
(RFA)of 1980, the Unfunded Mandates Reform Act of 1995, and Executive Order 13132. Executive Order 12866 and Regulatory Flexibility Act As discussed above, these regulations were published as an interim final rule on March 26, 2008. Because no notice of proposed rulemaking was required, the provisions of the RFA do not apply. Further, this document does not meet the criteria for a significant regulatory action as specified in Executive Order 12866. Unfunded Mandates Reform Act Section 202 of the Unfunded Mandates Reform Act of 1995, Public Law 104-4, requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditures in any one year by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation). We believe that this final rule will not impose any mandates on State, local, or tribal governments or the private sector that would result in an expenditure of $100 million or more (adjusted for inflation) in any given year, and that a full analysis under the Unfunded Mandates Reform Act is not necessary. Executive Order 13132 Executive Order 13132, Federalism, establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct requirements or costs on State and local governments, preempts State law, or otherwise has Federalism implications. In reviewing this final rule under the threshold criteria of Executive Order 13132, Federalism, we have determined that this final rule would not significantly limit the rights, roles, and responsibilities of State or local governments. We have determined, therefore, that a full analysis under Executive Order 13132 is not necessary. C. Paperwork Reduction Act In accordance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we are required to solicit public comments, and receive final OMB approval, on any information collection requirements set forth in rulemaking. This final rule will not impose any information collection burden or affect information currently collected by OIG. Accordingly, the interim final rule amending 42 CFR chapter V, subchapter B, which was published in the **Federal Register** at 73 FR 15937 on March 26, 2008, is adopted as a final rule without change. Dated: July 3, 2008. Daniel R. Levinson, Inspector General. Approved: July 3, 2008. Michael O. Leavitt, Secretary. [FR Doc. E8-15777 Filed 7-16-08; 8:45 am] BILLING CODE 4152-01-M DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 23 [FWS-R9-IA-2008-0003] [96000-1671-0000-P5] RIN 1018-AV70 Revision of Regulations Implementing the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES); Import and Export of Sturgeon Caviar AGENCY: Fish and Wildlife Service, Interior. ACTION: Direct final rule. SUMMARY: We, the Fish and Wildlife Service (FWS), are amending certain provisions related to international trade in sturgeon caviar in the regulations that implement the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES). We are reducing the quantity of caviar that may be imported or exported under the CITES personal effects exemption and amending the requirements for import of caviar from shared stocks subject to quotas. These changes are not controversial and will bring U.S. regulations in line with revisions adopted by consensus at the most recent meeting of the Conference of the Parties to CITES (June 2007). The revised regulations will help us more effectively promote species conservation, help us continue to fulfill our responsibilities under the Treaty, and help those affected by CITES to understand how to conduct lawful international trade in sturgeon caviar. DATES: This rule is effective September 15, 2008 without further action, unless adverse comment is received or postmarked on or before August 18, 2008. If we receive adverse comment, then we will publish a timely withdrawal of the rule in the **Federal Register** . ADDRESSES: You may submit comments by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the instructions for submitting comments. • *U.S. mail or hand-delivery* : Public Comments Processing, Attn: RIN 1018-AV70; Division of Policy and Directives Management; U.S. Fish and Wildlife Service; 4401 N. Fairfax Drive, Suite 222; Arlington, VA 22203. We will not accept e-mail or faxes. We will post all comments on *http://www.regulations.gov* . This generally means that we will post any personal information you provide us (see the **Public Comments** section at the end of SUPPLEMENTARY INFORMATION for further information about submitting comments). FOR FURTHER INFORMATION CONTACT: Robert R. Gabel, Chief, Division of Management Authority; U.S. Fish and Wildlife Service; 4401 N. Fairfax Drive, Suite 212; Arlington, VA 22203 (telephone,
(703)358-2093; fax,
(703)358-2280). SUPPLEMENTARY INFORMATION: Background CITES was negotiated in 1973 in Washington, DC, at a conference attended by delegations from 80 countries. The United States ratified the Treaty on September 13, 1973, and it entered into force on July 1, 1975, after the required 10 countries had ratified it. Currently 172 countries have ratified, accepted, approved, or acceded to CITES; these countries are known as Parties. Section 8A of the Endangered Species Act of 1973, as amended in 1982 (16 U.S.C. 1531 *et seq.* ), designates the Secretary of the Interior as the U.S. Management Authority and U.S. Scientific Authority for CITES. These authorities have been delegated to the Fish and Wildlife Service. The original U.S. regulations implementing CITES took effect on May 23, 1977 (42 FR 10465, February 22, 1977), after the first meeting of the Conference of the Parties
(CoP)was held. The CoP meets every 2 to 3 years to vote on proposed resolutions and decisions that interpret and implement the text of the Treaty and on amendments to the listing of species in the CITES Appendices. The current U.S. CITES regulations took effect on September 24, 2007, and incorporate provisions from applicable resolutions and decisions adopted at meetings of the Conference of the Parties up to and including the thirteenth meeting (CoP13), which took place in 2004. Article VII(3) of the Treaty provides for the import, export, or re-export of specimens that are personal or household effects (see the definitions in 50 CFR 23.5) without CITES documents under specific circumstances. For some species, including sturgeon and paddlefish (Acipenseriformes), the Parties have established limits on the quantity of certain specimens that may be transported as personal and household effects. At CoP14, in June 2007, the Parties agreed to reduce the quantity of sturgeon or paddlefish caviar that may be imported or exported under the personal effects exemption from 250 grams to 125 grams (see Resolution Conf. 12.7 (Rev. CoP14) and Resolution Conf. 13.7 (Rev. CoP14)). This change was originally recommended by the International Sturgeon Enforcement Workshop to Combat Illegal Trade in Caviar (Brussels, 2006) and was endorsed by the United States and adopted by consensus at CoP14. We are amending 50 CFR 23.15(c)(3)(i) to incorporate this change. The Parties also agreed to a new quota-setting process for caviar from shared stocks, including a change in the quota year so that it will coincide with the harvest season rather than the calendar year. Previously, under Resolution Conf. 12.7 (Rev. CoP13), “Conservation of and trade in sturgeons and paddlefish,” caviar from shared stocks subject to quotas (i.e., the Black Sea, Caspian Sea, and Amur River basins) had to be exported by the end of the calendar year in which it was harvested and processed. At CoP14, the Parties agreed that, from 2008 onward, the quota year will begin on the first of March and end on the last day of February of the following year. Exports of caviar from shared stocks subject to quotas must take place during the quota year in which the caviar is harvested and processed. In addition, the sturgeon resolution was amended to specifically state that quotas must not be detrimental to the survival of the species in the wild and to remove the requirement that the Secretariat must confirm that the quotas have been agreed to by all relevant countries (see Resolution Conf. 12.7 (Rev. CoP14)). These changes were adopted by consensus at CoP14. We are amending 50 CFR 23.71(d) to reflect the relevant changes to the quota-setting process for caviar from shared stocks. We are publishing this rule without a prior proposal because this is a non-controversial action that, in the best interest of the regulated public, should be undertaken in as timely a manner as possible. The Parties agreed by consensus that these changes are appropriate for the conservation of the species and implementation of the Treaty. As a Party to CITES, the United States has the responsibility under Article II(4) to ensure that all trade is consistent with the Treaty, which includes aligning import, export, and re-export provisions in a timely manner as agreed by the Parties. Thus, we have good cause to find that standard notice and pubic comment procedures would be unnecessary and contrary to the public interest. The rule will be effective, as published in this document, on the effective date specified in the DATES section of this document, unless we receive significant adverse comments on or before the comment due date specified in the DATES section of this document. Significant adverse comments are comments that provide strong justifications as to why the rule should not be adopted or why it should be changed. If we receive significant adverse comments, we will publish a notice in the **Federal Register** withdrawing this rule before the effective date. In the event that we do receive significant adverse comments, we will engage in the normal rulemaking process to promulgate these changes to 50 CFR part 23. Therefore, elsewhere in today's issue of the **Federal Register** , we have published a proposed rule regarding these regulatory changes. We will give the same consideration to comments submitted in response to either the direct final rule or the proposed rule; you do not need to submit separate comments for both documents. Required Determinations *Regulatory Planning and Review* : This is not a significant regulatory action under Executive Order 12866 and therefore was not reviewed by the Office of Management and Budget (OMB). a. This rule will not have an annual economic effect of $100 million or more or adversely affect a part of the economy, productivity, jobs, the environment, or other units of government. This rule reduces the quantity of sturgeon or paddlefish caviar that an individual may import or export under the personal effects exemption (i.e., without a CITES document) from 250 grams to 125 grams. The personal effects exemption applies only to specimens for personal use that are hand-carried or checked as personal baggage on the same boat, plane, etc., as the traveler. This rule also informs the public of a change in the quota-setting process and timeframe for export of caviar from shared stocks (i.e., the Black Sea, Caspian Sea, and Amur River basins). Publication of this rule will assist U.S. businesses in complying with CITES requirements when engaging in international trade in sturgeon and paddlefish caviar. We do not expect that this rule will have a significant effect on the volume or dollar value of sturgeon or paddlefish caviar imported, exported, or re-exported to and from the United States. There is no indication that this rule would result in statistically significant higher or lower levels of trade, permit applications, or permit issuance or denial. An economic analysis is not necessary for this rule as it will not have an economic impact on large or small entities. b. This rule will not create inconsistencies with other agencies' actions. As the lead agency for implementing CITES in the United States, we are responsible for monitoring imports and exports of CITES wildlife and plants, including their parts, products, and derivatives, and issuing import and export documents under CITES. c. This rule will not materially affect entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients. d. This rule will not raise novel legal or policy issues. As a Party to CITES, the United States is committed to fully and effectively implementing the Convention. All sturgeon and paddlefish (Acipenseriformes) are listed under CITES. This rule informs individuals and businesses of provisions adopted at the most recent CoP for international trade in sturgeon and paddlefish caviar. *Regulatory Flexibility Act* : Under the Regulatory Flexibility Act (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996), whenever a Federal agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities (i.e., small businesses, small organizations, and small government jurisdictions) (5 U.S.C. 601 *et seq.* ). However, no regulatory flexibility analysis is required if the head of an agency certifies that the rule would not have a significant economic impact on a substantial number of small entities. Thus, for a regulatory flexibility analysis to be required, impacts must exceed a threshold for ‘‘significant impact'' and a threshold for a ‘‘substantial number of small entities.'' See 5 U.S.C. 605(b). SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule would not have a significant economic impact on a substantial number of small entities. The U.S. Small Business Administration
(SBA)defines a small business as one with annual revenue or employment that meets or is below an established size standard. We expect that the majority of the entities involved with international caviar trade would be considered small as defined by the SBA. The declared value for U.S. international trade in sturgeon and paddlefish caviar was $13.4 million in 2005 and $13.7 million in 2006. These new regulations create no substantial fee or paperwork changes in the permitting process. The regulatory changes are not major in scope and would create only a modest financial or paperwork burden on the affected members of the general public. This rule benefits businesses engaged in international caviar trade by providing updated regulations for the international trade of CITES specimens. We do not expect these benefits to be significant under the Regulatory Flexibility Act. The authority to enforce CITES requirements already exists under the Endangered Species Act and is carried out by regulations contained in 50 CFR part 23. The requirements that must be met to import, export, and re-export CITES species are based on the text of CITES, which has been in effect in the United States since 1975. We therefore certify that this rule will not have a significant economic effect on a substantial number of small entities as defined under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). A Regulatory Flexibility Analysis is not required. Accordingly, a Small Entity Compliance Guide is not required. *Small Business Regulatory Enforcement Fairness Act* : This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: a. Does not have an annual effect on the economy of $100 million or more. This rule provides the importing and exporting community in the United States with updated regulations implementing CITES. This rule will not have a negative effect on this part of the economy. This rule will affect all caviar importers, exporters, and re-exporters equally, and the benefits of having updated guidance on complying with CITES requirements will be evenly spread among all businesses, whether large or small. There is not a disproportionate share of benefits for small or large businesses. b. Will not cause a major increase in costs or prices for consumers; individual industries; Federal, State, tribal, or local government agencies; or geographic regions. This rule may result in a small increase in the number of applications for import/export of caviar for personal use. A CITES document is now required for any amount of caviar over 125g (a reduction from the 250g previously allowed without a permit). c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This rule will assist U.S. businesses and individuals traveling abroad in ensuring that they are meeting all current CITES requirements, thereby decreasing the possibility that shipments may be delayed or even seized in another country that has implemented CITES resolutions not yet incorporated into U.S. regulations. *Unfunded Mandates Reform Act* : Under the Unfunded Mandates Reform Act (2 U.S.C. 1501, *et seq.* ): a. This rule will not significantly or uniquely affect small governments. A Small Government Agency Plan is not required. As the lead agency for implementing CITES in the United States, we are responsible for monitoring import and export of CITES wildlife and plants, including their parts, products, and derivatives, and issuing import and export documents under CITES. The structure of the program imposes no unfunded mandates. Therefore, this rule has no effect on small governments' responsibilities. b. This rule will not produce a Federal requirement of $100 million or greater in any year and is not a “significant regulatory action” under the Unfunded Mandates Reform Act. *Takings* : Under Executive Order 12630, this rule does not have significant takings implications. A takings implication assessment is not required. This rule is not considered to have takings implications because it does not further restrict the import, export, or re-export of CITES specimens. Import, export, and re-export of caviar in amounts greater than 125 grams will still be allowed with the appropriate CITES documents. The rule updates the regulations for the import, export, and re-export of CITES specimens, which will assist the importing and exporting community in conducting international trade in CITES specimens. *Federalism* : These revisions to part 23 do not contain significant Federalism implications. A Federalism Assessment under Executive Order 13132 is not required. *Civil Justice Reform* : Under Executive Order 12988, the Office of the Solicitor has determined that this rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order. *Paperwork Reduction Act* : This rule does not contain any new information collections or recordkeeping requirements for which OMB approval is required under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). We may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. *National Environmental Policy Act (NEPA)* : The FWS has determined that this direct final rule is categorically excluded from further NEPA review as provided by 516 DM 2, Appendix 1.9, of the Department of the Interior National Environmental Policy Act Revised Implementing Procedures (69 FR 10866, March 8, 2004). No further documentation will be made. *Government-to-Government Relationship with Tribes* : Under the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951) and 512 DM 2, we have evaluated possible effects on federally recognized Indian Tribes and have determined that there are no effects. Individual tribal members must meet the same regulatory requirements as other individuals who trade internationally in CITES species. *Energy Supply, Distribution or Use* : On May 18, 2001, the President issued Executive Order 13211 on regulations that significantly affect energy supply, distribution, and use. This rule revises the current regulations in 50 CFR part 23 that implement CITES. The regulations provide procedures to assist individuals and businesses that import, export, and re-export CITES wildlife and plants, and their parts, products, and derivatives, to meet international requirements. This rule will not significantly affect energy supplies, distribution, and use. Therefore, this action is a not a significant energy action and no Statement of Energy Effects is required. *Clarity of this regulation* : We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:
(a)Be logically organized;
(b)Use the active voice to address readers directly;
(c)Use clear language rather than jargon;
(d)Be divided into short sections and sentences; and
(e)Use lists and tables wherever possible. If you feel that we have not met these requirements, send us comments by one of the methods listed in the ADDRESSES section. To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that are unclearly written, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc. Public Comments We are seeking comments on whether the provisions in this direct final rule allow the affected public to effectively comply with CITES. You may submit your comments and materials concerning this rule by one of the methods listed in the ADDRESSES section. We will not accept comments sent by e-mail or fax or to an address not listed in the ADDRESSES section. We will post your entire comment—including your personal identifying information—on *http://www.regulations.gov* . If you provide personal identifying information in your written comments you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. Comments and materials we receive, as well as supporting documentation we used in preparing this direct final rule, will be available for public inspection on *http://www.regulations.gov* , or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service; Division of Management Authority; 4401 N. Fairfax Drive, Suite 212; Arlington, VA 22203; telephone,
(703)358-2093. List of Subjects in 50 CFR Part 23 Animals, Endangered and threatened species, Exports, Fish, Foreign officials, Foreign trade, Imports, Reporting and recordkeeping requirements, Transportation, Treaties, Wildlife. Regulation Promulgation For the reasons given in the preamble, we amend title 50, chapter I, subchapter B of the CFR as follows: PART 23—[AMENDED] 1. The authority citation for part 23 continues to read as follows: Authority: Convention on International Trade in Endangered Species of Wild Fauna and Flora (March 3, 1973), 27 U.S.T. 1087; and Endangered Species Act of 1973, as amended, 16 U.S.C. 1531 *et seq.* § 23.15 [Amended] 2. Amend § 23.15(c)(3)(i), the first entry in the table, by removing the words “250 gm” in the Quantity column and by adding in their place the words “125 gm.” 3. Amend § 23.71(d) by removing paragraph (d)(4) and revising paragraphs (d)(1), (d)(2), and (d)(3) to read as follows: § 23.71 How can I trade internationally in sturgeon caviar?
(d)* * *
(1)The relevant countries have established annual export quotas for the shared stocks that were derived from catch quotas agreed among the countries. The quotas are based on an appropriate regional conservation strategy and monitoring regime and are not detrimental to the survival of the species in the wild.
(2)The quotas have been communicated to the CITES Secretariat and the Secretariat has communicated the annual export quotas to CITES Parties.
(3)The caviar is exported during the quota year (March 1 - last day of February) in which it was harvested and processed. Dated: June 5, 2008 David M. Verhey Acting Assistant Secretary for Fish and Wildlife and Parks [FR Doc. E8-16195 Filed 7-16-08; 8:45 am] BILLING CODE 4310-55-S DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 070717340-8451-02] RIN 0648-XJ06 Fisheries of the Northeastern United States; Atlantic Mackerel, Squid, and Butterfish Fisheries; Closure of the Trimester II Fishery for *Loligo* Squid AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Temporary rule; closure. SUMMARY: NMFS announces that the directed fishery for *Loligo* squid in the Exclusive Economic Zone
(EEZ)will be closed effective 0001 hours, July 17, 2008. Vessels issued a Federal permit to harvest *Loligo* squid may not retain or land more than 2,500 lb (1,134 kg) of *Loligo* squid per trip for the remainder of the trimester (through August 31, 2008). This action is necessary to prevent the fishery from exceeding its Trimester II quota and to allow for effective management of this stock. DATES: Effective 0001 hours, July 17, 2008, through 2400 hours, August 31, 2008. FOR FURTHER INFORMATION CONTACT: Don Frei, Fishery Management Specialist, 978-281-9221, Fax 978-281-9135. SUPPLEMENTARY INFORMATION: Regulations governing the *Loligo* squid fishery are found at 50 CFR part 648. The regulations require specifications for maximum sustainable yield, initial optimum yield, allowable biological catch, domestic annual harvest (DAH), domestic annual processing, joint venture processing, and total allowable levels of foreign fishing for the species managed under the Atlantic Mackerel, Squid, and Butterfish Fishery Management Plan. The procedures for setting the annual initial specifications are described in § 648.21. The 2008 specification of DAH for *Loligo* squid was set at 16,977 mt (73 FR 18443, April 4, 2008). This amount is allocated by trimester, as shown below. Table 1. *Loligo* Squid Trimester Allocations. Quarter Percent Metric Tons 1 Research Set-aside
(mt)I (Jan-Apr) 43 7,300 N/A II (May-Aug) 17 2,886 N/A III (Sep-Dec) 40. 6,791 N/A Total 100 16,997 23 1 Trimester allocations after 23-mt research set-aside deduction. Section 648.22 requires NMFS to close the directed *Loligo* squid fishery in the EEZ when 90 percent of the trimester allocation is harvested in Trimesters I and II, and when 95 percent of the total annual DAH has been harvested in Trimester III. NMFS is further required to notify, in advance of the closure, the Executive Directors of the Mid-Atlantic, New England, and South Atlantic Fishery Management Councils; mail notification of the closure to all holders of *Loligo* squid permits at least 72 hR before the effective date of the closure; provide adequate notice of the closure to recreational participants in the fishery; and publish notification of the closure in the **Federal Register** . The Administrator, Northeast Region, NMFS, based on dealer reports and other available information, has determined that 90 percent of the DAH for *Loligo* squid in Trimester II will be harvested. Therefore, effective 0001 hours, July 17, 2008, the directed fishery for *Loligo* squid is closed and vessels issued Federal permits for *Loligo* squid may not retain or land more than 2,500 lb (1,134 kg) of *Loligo* during a calendar day. The directed fishery will reopen effective 0001 hours, September 1, 2008, when the Trimester III quota becomes available. Classification This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866. Authority: 16 U.S.C. 1801 *et seq.* Dated: July 11, 2008. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. 08-1440 Filed 7-14-08; 2:00 pm]
Connectionstraces to 38
Traces to 38 documents
U.S. Code
36 references not yet in our index
  • Pub. L. 108-447
  • 9 CFR 390
  • 9 CFR 390.9(a)(1)
  • 9 CFR 390.10
  • 9 CFR 390.9
  • 9 CFR 320.1(a)
  • 9 CFR 320.1(b)
  • 9 CFR 320.1
  • 9 CFR 320.4
  • 21 USC 451-471
  • 7 CFR 1.3
  • 14 CFR 39
  • 1 CFR 51
  • 14 CFR 43
  • 20 CFR 404
  • 21 CFR 892
  • Pub. L. 94-295
  • Pub. L. 101-629
  • Pub. L. 105-115
  • Pub. L. 107-250
  • Pub. L. 108-214
  • 21 CFR 807
  • 5 USC 601-612
  • Pub. L. 104-4
  • 40 CFR 52
  • 427 U.S. 246
  • 40 CFR 63
  • 40 CFR 9
  • Pub. L. 104-113
  • 42 CFR 1008
  • Pub. L. 104-101
  • 50 CFR 23
  • 50 CFR 23.5
  • 50 CFR 23.15(c)(3)(i)
  • 50 CFR 23.71(d)
  • 50 CFR 648
Citation graph
cites case law
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Final rule
U.S.C.§ 552
U.S.C.§ 642
U.S.C.§ 49
Fed. Reg.Notices
Fed. Reg.Notices
U.S.C.§ 301
Fed. Reg.Proposed Rules
U.S.C.§ 106
C.F.R.§ 39.19
SCOTUS427 U.S. 246
Pub. L.Pub. L. 108-447
Cite9 CFR 390
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