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Code · REGISTER · 2007-12-05 · PROPOSED RULES · Unknown

Unknown. Final rule

82,268 words·~374 min read·/register/2007/12/05/07-5935

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--- schema: federal-register doc_type: fedreg source_file: FR-2007-12-05.xml --- 72 233 Wednesday, December 5, 2007 Contents AID Agency for International Development NOTICES Agency information collection activities; proposals, submissions, and approvals, 68553 07-5935 Agricultural Agricultural Marketing Service RULES Oranges, grapefruit, tangerines, and tangelos grown in Florida, 68471-68473 E7-23529 PROPOSED RULES Grade standards: Sweet cherries Withdrawn, 68542 E7-23531 NOTICES Grants and cooperative agreements; availability, etc.:
Federal-State Marketing Improvement Program, 68553-68554 E7-23528 Agriculture Agriculture Department See Agricultural Marketing Service See Animal and Plant Health Inspection Service See Grain Inspection, Packers and Stockyards Administration See Rural Utilities Service Animal Animal and Plant Health Inspection Service NOTICES Reports and guidance documents; availability, etc.: National Animal Identification System; Program Standards and Technical Reference; update, 68554-68555 E7-23524 Centers Centers for Medicare & Medicaid Services RULES Medicare:
Medicare Advantage and Part D prescription drug contract determinations, appeals, and intermediate sanctions processes; revisions, 68700-68741 07-5946 Children Children and Families Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 68586 07-5932 Civil Civil Rights Commission NOTICES Reports and guidance documents; availability, etc.: Information quality guidelines, 68557-68562 E7-23526 Coast Guard Coast Guard RULES Drawbridge operations:
New Jersey, 68503-68504 E7-23568 Ports and waterways safety; regulated navigation areas, safety zones, security zones, etc.: Chicago Harbor, Navy Pier East, Chicago, IL, 68506 E7-23570 Sloop Channel, Hempstead, NY, 68504-68506 E7-23569 PROPOSED RULES Drawbridge operations: Florida, 68548-68551 E7-23564 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration Education Education Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 68572 E7-23563 Privacy Act; systems of records, 68572-68576 E7-23541 Employee Employee Benefits Security Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 68593-68594 E7-23554 Employment Employment and Training Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 68594-68595 E7-23534 E7-23555 Energy Energy Department See Federal Energy Regulatory Commission EPA Environmental Protection Agency RULES Air pollution control; new motor vehicles and engines:
Compression-ignition marine engines at or above 30 liters per cylinder; emissions control, 68518-68525 E7-23557 Air quality implementation plans; approval and promulgation; various States: Minnesota, 68508-68511 E7-23496 Ohio; withdrawn, 68515 E7-23504 Virginia, 68511-68515 E7-23386 Air quality planning purposes; designation of areas: Various States; correction, 68515-68518 E7-23498 Pesticide programs: Plant-incorporated protectants; procedures and requirements— Bacillus thuringiensis Vip3Aa20 protein and genetic material necessary for production in corn; tolerance requirement exemption, 68525-68529 E7-23308 Pesticides; tolerances in food, animal feeds, and raw agricultural commodities:
Dichlorvos, 68662-68698 E7-23571 Ethalfluralin, 68529-68534 E7-23578 Spinosad, 68534-68541 E7-23579 PROPOSED RULES Air quality implementation plans; approval and promulgation; various States: Minnesota, 68551 E7-23497 NOTICES Pesticide registration, cancellation, etc.: Chlorpyrifos-methyl, 68580-68581 E7-23300 Dichlorvos, 68581-68582 E7-23566 Naphthalene acetic acid, etc., 68582-68584 E7-23306 Executive Executive Office of the President See Management and Budget Office See Trade Representative, Office of United States FAA Federal Aviation Administration RULES Air carrier certification and operations:
Transport category airplanes— Enhanced airworthiness program for airplane systems and fuel tank safety; correction, 68618 Z7-21434 Organization, functions, and authority delegations: Transportation Department address change and migration to Federal Docket Management System, 68473-68477 E7-23422 Federal Energy Federal Energy Regulatory Commission NOTICES Electric rate and corporate regulation combined filings, 68576-68578 E7-23523 E7-23553 Meetings: Proxy groups composition for determining gas and oil pipeline return on equity; technical conference, 68578-68580 E7-23552 Federal Highway Federal Highway Administration RULES Engineering and traffic operations:
Temporary traffic control devices; work zone safety protection measures for workers and motorists, 68480-68491 E7-23581 Federal Housing Federal Housing Enterprise Oversight Office PROPOSED RULES Risk-based capital: Loss severity amendments, 68656-68659 07-5101 FMC Federal Maritime Commission NOTICES Agreements filed, etc., 68584 E7-23583 Ocean transportation intermediary licenses: DFHU Worldwide Shipping et al., 68584-68585 E7-23597 Junkanoo Shipping, Inc., et al., 68585 E7-23584 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies:
Formations, acquisitions, and mergers, 68585 E7-23548 Permissible nonbanking activities, 68585-68586 E7-23547 Federal Open Market Committee: Domestic policy directives, 68586 E7-23527 Federal Retirement Federal Retirement Thrift Investment Board NOTICES Meetings; Sunshine Act, 68586 07-5947 Food Food and Drug Administration RULES Animal drugs, feeds, and related products: Carprofen, 68477-68478 E7-23516 Monensin, 68478-68479 E7-23519 Monensin USP, 68479-68480 E7-23517 Foreign Foreign Assets Control Office NOTICES Sanctions; blocked persons, specially designated nationals, terrorists, narcotics traffickers, and foreign terrorist organizations:
Foreign Narcotics Kingpin Designation Act; additional designations; list, 68614-68616 07-5920 GIPSA Grain Inspection, Packers and Stockyards Administration NOTICES Agency designation actions: Various States, 68555-68556 E7-23530 Health Health and Human Services Department See Centers for Medicare & Medicaid Services See Children and Families Administration See Food and Drug Administration See Health Resources and Services Administration See National Institutes of Health Health Health Resources and Services Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 68587 E7-23538 Homeland Homeland Security Department See Coast Guard Housing Housing and Urban Development Department See Federal Housing Enterprise Oversight Office Indian Indian Affairs Bureau RULES No Child Left Behind Act; implementation:
Homeliving programs, 68491-68502 E7-23330 Interior Interior Department See Indian Affairs Bureau International International Trade Administration NOTICES Antidumping: Brake rotors from— China, 68562 E7-23574 Helical spring lock washers from— China, 68562-68563 E7-23572 Sodium nitrite from— China and Germany, 68563-68568 E7-23489 Countervailing duties: Sodium nitrite from— China, 68568-68571 E7-23573 *Applications, hearings, determinations, etc.:* Battelle Memorial Institute et al., 68568 E7-23576 International International Trade Commission NOTICES Import investigations:
U.S. Generalized System of Preferences; 2007 review of additions and removals; possible modifications; advice, 68591-68592 E7-23560 Justice Justice Department NOTICES Pollution control; consent judgments: Losada et al., 68592 07-5937 Labor Labor Department See Employee Benefits Security Administration See Employment and Training Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 68592-68593 E7-23535 Management Management and Budget Office NOTICES Agency information collection activities; proposals, submissions, and approvals, 68608-68609 E7-23540 NIH National Institutes of Health NOTICES Agency information collection activities; proposals, submissions, and approvals, 68587-68588 E7-23515 Inventions, Government-owned; availability for licensing, 68588-68590 E7-23514 Meetings:
National Center for Complementary and Alternative Medicine, 68590 07-5928 National Eye Institute, 68590 07-5927 National Institute of Child Health and Human Development, 68590 07-5930 National Library of Medicine, 68590-68591 07-5929 Scientific Review Center, 68591 07-5926 National Labor National Labor Relations Board RULES Practice and procedure: Freedom of Information Act requests; adverse determinations; appeals, 68502-68503 E7-23521 NOAA National Oceanic and Atmospheric Administration PROPOSED RULES Fishery conservation and management:
Caribbean, Gulf, and South Atlantic fisheries— Commercial dolphin/wahoo, 68551-68552 E7-23596 NOTICES Reports and guidance documents; availability, etc.: U.S. Climate Change Science Program Synthesis and Assessment Product, 68571-68572 E7-23595 Nuclear Nuclear Regulatory Commission NOTICES Environmental statements; availability, etc.: PPL Susquehanna, LLC, 68598-68608 E7-23537 *Applications, hearings, determinations, etc.:* Duke Power Co. LLC, 68595-68597 E7-23542 South Texas Project Nuclear Operating Co., 68597 E7-23539 STP Nuclear Operating Co., 68598 E7-23536 Office Office of Federal Housing Enterprise Oversight See Federal Housing Enterprise Oversight Office Office Office of Management and Budget See Management and Budget Office Office of U.S.
Trade Office of United States Trade Representative See Trade Representative, Office of United States Pension Pension Benefit Guaranty Corporation PROPOSED RULES Single-employer and multiemployer plans: Termination information disclosure, 68542-68548 E7-23577 RUS Rural Utilities Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 68556-68557 E7-23561 SEC Securities and Exchange Commission NOTICES Meetings; Sunshine Act, 68610 E7-23602 Self-regulatory organizations; proposed rule changes:
Chicago Board Options Exchange, Inc., 68610-68613 E7-23533 New York Stock Exchange LLC, 68613-68614 E7-23532 State State Justice Institute NOTICES Reports and guidance documents; availability, etc.: Grants, cooperative agreements, and contracts; guidelines, 68620-68653 07-5921 Trade Trade Representative, Office of United States NOTICES World Trade Organization: Dispute settlement panel proceedings— Brazil and Canada; agricultural products; U.S. domestic support, 68609-68610 E7-23575 Transportation Transportation Department See Federal Aviation Administration See Federal Highway Administration Treasury Treasury Department See Foreign Assets Control Office See United States Mint U.S.
Mint United States Mint NOTICES Committees; establishment, renewal, termination, etc.: Citizens Coinage Advisory Committee, 68616-68617 E7-23546 Veterans Veterans Affairs Department RULES Adjudication; pensions, compensation, dependency, etc.: Persian Gulf War veterans; compensation for disabilities resulting from undiagnosed illnesses; presumptive period extension, 68507-68508 E7-23545 Separate Parts In This Issue Part II State Justice Institute, 68620-68653 07-5921 Part III Office of Federal Housing Enterprise Oversight, Federal Housing Enterprise Oversight Office, 68656-68659 07-5101 Part IV Environmental Protection Agency, 68662-68698 E7-23571 Part V Health and Human Services Department, Centers for Medicare & Medicaid Services, 68700-68741 07-5946 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 72 233 Wednesday, December 5, 2007 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 905 [Docket No. AMS-FV-07-0088; FV07-905-1 FIR] Oranges, Grapefruit, Tangerines, and Tangelos Grown in Florida;
Decreased Assessment Rate AGENCY: Agricultural Marketing Service, USDA. ACTION: Final rule. SUMMARY: The Department of Agriculture
(USDA)is adopting, as a final rule, without change, an interim final rule which decreased the assessment rate established for the Citrus Administrative Committee (Committee) for the 2007-08 and subsequent fiscal periods from $0.008 to $0.0072 per 4/5 bushel carton of oranges, grapefruit, tangerines, and tangelos handled. The Committee locally administers the marketing order which regulates the handling of oranges, grapefruit, tangerines, and tangelos grown in Florida. Assessments upon Florida citrus handlers are used by the Committee to fund reasonable and necessary expenses of the program. The fiscal period begins August 1 and ends July 31. The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated. EFFECTIVE DATE: January 4, 2008. FOR FURTHER INFORMATION CONTACT: Doris Jamieson, Marketing Specialist, or Christian D. Nissen, Regional Manager, Southeast Marketing Field Office, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA; Telephone:
(863)324-3375, Fax:
(863)325-8793, or E-mail: *Doris.Jamieson@usda.gov* or *Christian.Nissen@usda.gov* . Small businesses may request information on complying with this regulation by contacting Jay Guerber, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC 20250-0237; Telephone:
(202)720-2491, Fax:
(202)720-8938, or E-mail: *Jay.Guerber@usda.gov* . SUPPLEMENTARY INFORMATION: This rule is issued under Marketing Agreement No. 84 and Marketing Order No. 905, both as amended (7 CFR part 905), regulating the handling of oranges, grapefruit, tangerines, and tangelos grown in Florida, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” USDA is issuing this rule in conformance with Executive Order 12866. This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, Florida citrus handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as issued herein will be applicable to all assessable oranges, grapefruit, tangerines, and tangelos grown in Florida beginning August 1, 2007, and continue until amended, suspended, or terminated. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule. The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling. This rule continues in effect the action that decreased the assessment rate established for the Committee for the 2007-08 and subsequent fiscal periods from $0.008 per 4/5 bushel carton to $0.0072 per 4/5 bushel carton of oranges, grapefruit, tangerines, and tangelos grown in Florida. The Florida citrus marketing order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are producers and handlers of oranges, grapefruit, tangerines, and tangelos. They are familiar with the Committee's needs and with the costs for goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input. For the 2005-06 and subsequent fiscal periods, the Committee recommended, and USDA approved, an assessment rate that would continue in effect from fiscal period to fiscal period unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other information available to USDA. The Committee met on May 29, 2007, and unanimously recommended 2007-08 expenditures of $275,000 and an assessment rate of $0.0072 per 4/5 bushel of oranges, grapefruit, tangerines, and tangelos grown in Florida. In comparison, last year's budgeted expenditures were $241,000. The assessment rate of $0.0072 is $0.0008 lower than the rate previously in effect. This reduction was recommended because the Committee experienced an unanticipated increase in shipments for the 2006-07 fiscal period and had revenues greater than expenses. In addition, the industry has continued to recover from the hurricane damage sustained during the 2004-05 and 2005-06 seasons, which is expected to have a positive affect on total production. The major expenditures recommended by the Committee for the 2007-08 fiscal year include $112,000 for salaries, $25,000 for Manifest Department—Florida Department of Agriculture and Customer Services (FDACS), $17,800 for retirement plan, and $14,550 for insurance and bonds. Budgeted expenses for these items in 2006-07 were $110,000, $25,000, $17,250, and $14,550, respectively. The assessment rate recommended by the Committee was derived by dividing anticipated expenses by expected shipments of oranges, grapefruit, tangerines, and tangelos. Florida citrus shipments for the year are estimated at 30 million 4/5 bushels which should provide $216,000 in assessment income. Income derived from handler assessments, along with interest income and funds from the Committee's authorized reserve will be adequate to cover budgeted expenses. Funds in the reserve (currently approximately $60,000) will be kept within the maximum permitted by the order of not to exceed one half of one fiscal period's expenses as stated in § 905.42(a). The assessment rate will continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other available information. Although this assessment rate is in effect for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The Committee's 2007-08 budget and those for subsequent fiscal periods will be reviewed and, as appropriate, approved by USDA. Final Regulatory Flexibility Analysis Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service
(AMS)has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis. The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. There are approximately 8,000 producers of oranges, grapefruit, tangerines, and tangelos in the production area and approximately 55 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration
(SBA)as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $6,500,000 (13 CFR 121.201). Based on industry and Committee data, the average annual f.o.b. price for fresh Florida citrus during the 2005-06 season was approximately $11.50 per 4/5 -bushel carton, and total fresh shipments were approximately 29.1 million cartons. Using the average f.o.b. price, at least 70 percent of the Florida citrus handlers could be considered small businesses under SBA's definition. In addition, based on production and producer prices reported by the National Agricultural Statistics Service, and the total number of Florida citrus producers, the average annual producer revenue is approximately $55,540. Therefore, the majority of handlers and producers of Florida citrus may be classified as small entities. This rule continues in effect the action that decreased the assessment rate established for the Committee and collected from handlers for the 2007-08 and subsequent fiscal periods from $0.008 to $0.0072 per 4/5 bushel carton of oranges, grapefruit, tangerines, and tangelos. The Committee unanimously recommended 2007-08 expenditures of $275,000 and an assessment rate of $0.0072 per 4/5 bushel carton. The assessment rate of $0.0072 is $0.0008 lower than the 2006-07 rate. The quantity of assessable oranges, grapefruit, tangerines, and tangelos for the 2007-08 season is estimated at 30 million 4/5 bushel cartons. Thus, the $0.0072 rate should provide $216,000 in assessment income. Income derived from handler assessments, along with interest income and funds from the Committee's authorized reserve will be adequate to cover budgeted expenses. The major expenditures recommended by the Committee for the 2007-08 fiscal year include $112,000 for salaries, $25,000 for Manifest Department—FDACS, $17,800 for retirement plan, and $14,550 for insurance and bonds. Budgeted expenses for these items in 2006-07 were $110,000, $25,000, $17,250, and $14,550, respectively. The reduction in the assessment rate was recommended by the Committee as a result of an unanticipated increase in shipments for the 2006-07 fiscal period, which produced revenues that were greater than expenses. In addition, the industry has continued to recover from the hurricane damage sustained during the 2004-05 and 2005-06 seasons, which is expected to have a positive impact on production. The Committee reviewed and unanimously recommended 2007-08 expenditures of $275,000. Prior to arriving at this budget, the Committee considered information from various sources including the Committee's Budget Subcommittee. Alternative expenditure levels were discussed by this group, based on different estimates of assessable cartons and budget expenses. The assessment rate of $0.0072 per 4/5 bushel carton of assessable oranges, grapefruit, tangerines, and tangelos was then determined by dividing the total recommended budget by the quantity of assessable Florida citrus, estimated at 30 million 4/5 bushel cartons for the 2007-08 season, taking into consideration the availability of reserve funds and interest income. This is approximately $59,000 under anticipated expenses, which the Committee determined to be acceptable. A review of historical information and preliminary information pertaining to the upcoming fiscal period indicates that the producer price for the 2007-08 season could range between $1.83 and $9.76 per 4/5 bushels of oranges, grapefruit, tangerines, and tangelos. Therefore, the estimated assessment revenue for the 2007-08 fiscal period as a percentage of total producer revenue could range between .07 and .39 percent. This action continues in effect the action that decreased the assessment obligation imposed on handlers. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to producers. However, decreasing the assessment rate reduces the burden on handlers, and may reduce the burden on producers. In addition, the Committee's meeting was widely publicized throughout the Florida citrus industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the May 29, 2007, meeting was a public meeting and all entities, both large and small, were able to express views on this issue. This action imposes no additional reporting or recordkeeping requirements on either small or large Florida citrus handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. AMS 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. USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule. An interim final rule concerning this action was published in the **Federal Register** on July 30, 2007 (72 FR 41423). Copies of that rule were also mailed or sent via facsimile to all citrus handlers. Finally, the interim final rule was made available through the Internet by USDA and the Office of the **Federal Register** . A 60-day comment period was provided for interested persons to respond to the interim final rule. The comment period ended on September 28, 2007, and no comments were received. A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: *http://www.ams.usda.gov/fv/moab.html.* Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section. After consideration of all relevant material presented, including the information and recommendation submitted by the Committee and other available information, it is hereby found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act. List of Subjects in 7 CFR Part 905 Grapefruit, Marketing agreements, Oranges, Reporting and recordkeeping requirements, Tangelos, Tangerines. PART 905—ORANGES, GRAPEFRUIT, TANGERINES, AND TANGELOS GROWN IN FLORIDA Accordingly, the interim final rule amending 7 CFR part 905 which was published at 72 FR 41423 on July 30, 2007, is adopted as a final rule without change. Dated: November 29, 2007. Lloyd C. Day, Administrator, Agricultural Marketing Service. [FR Doc. E7-23529 Filed 12-4-07; 8:45 am] BILLING CODE 3410-02-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Parts 11, 13, 17, 36, 91, 139, 150, 193, 404, and 406 Change in Address for the Department of Transportation
(DOT)and DOT Migration to the Federal Docket Management System
(FDMS)AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule; technical amendment. SUMMARY: This action updates the Department of Transportation
(DOT)addresses, changes references from the Docket Management System to the Federal Docket Management System (FDMS), and removes obsolete information listed in FAA regulations as a result of DOT's relocation, migration to the Federal electronic docket system, and closure of the DOT Branch Library. The intended effect of this action is to ensure that the regulated public is informed of address changes, electronic docket changes, and other administrative matters. DATES: Effective December 5, 2007. FOR FURTHER INFORMATION CONTACT: Barbara Dinkins, Office of Rulemaking, ARM-210, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591; telephone: (202-493-4657); facsimile: (202-267-5075); e-mail: *barbara.b.dinkins@faa.gov.* SUPPLEMENTARY INFORMATION: This technical amendment addresses the following administrative changes—
(1)The Department of Transportation
(DOT)relocation of its entire headquarters to 1200 New Jersey Avenue, SE., Washington, DC;
(2)The DOT migration to the governmentwide electronic Federal Document Management System
(FDMS)which replaces the old DOT Docket Management System (DMS); and
(3)Closure of DOT Transportation Branch Library. As a result of these changes, the FAA is amending 14 CFR parts 11, 13, 17, 36, 91, 139, 150, 193, 404, and 406. Because these actions are merely administrative in nature and removes outdated references, the FAA finds that notice and public procedure under 5 U.S.C. 553(b) is unnecessary. For the same reason, the FAA finds that good cause exists under 5 U.S.C. 5553(d) for making this amendment effective upon publication. List of Subjects 14 CFR Part 11 Administrative practice and procedure, Reporting and recordkeeping requirements. 14 CFR Part 13 Administrative practice and procedure, Air transportation, Aviation safety, Hazardous materials transportation, Investigations, Law enforcement, Penalties. 14 CFR Part 17 Administrative practice and procedure, Authority delegations (Government agencies), Government contracts. 14 CFR Part 36 Agriculture, Aircraft, Noise control. 14 CFR Part 91 Afghanistan, Agriculture, Air traffic control, Aircraft, Airmen, Airports, Aviation Safety, Canada, Cuba, Ethiopia, Freight, Mexico, Noise control, Political candidates, Reporting and recordkeeping requirements, Yugoslavia. 14 CFR Part 139 Air carriers, Airports, Aviation safety, Reporting and recordkeeping requirements. 14 CFR Part 150 Airports, Noise control. 14 CFR Part 193 Air transportation, Aviation safety, Reporting and recordkeeping requirements, Security measures. 14 CFR Part 404 Administrative practice and procedure, Space transportation and exploration. 14 CFR Part 406 Administrative practice and procedure, Confidential business information, Investigations, Penalties, Space transportation and exploration. The Amendments In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR chapters I and III as follows: PART 11—GENERAL RULEMAKING PROCEDURES 1. The authority citation for part 11 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. 2. Amend § 11.25 by revising the last sentence in paragraph
(a)introductory text to read as follows: § 11.25 How does FAA issue rules?
(a)* * * We also make all documents available to the public by posting them in the Federal Docket Management System at *http://www.regulations.gov.* 3. Amend § 11.33 by revising paragraph
(a)to read as follows: § 11.33 How can I track FAA's rulemaking activities?
(a)*Docket ID.* We assign a docket ID to each rulemaking document proceeding. Each rulemaking document FAA issues in a particular rulemaking proceeding, as well as public comments on the proceeding, will display the same docket ID. This ID allows you to search the Federal Docket Management System
(FDMS)for information on most rulemaking proceedings. You can view and copy docket materials during regular business hours at the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. Or you can view and download docketed materials through the Internet at *http://www.regulations.gov.* If you can't find the material in the electronic docket, contact the person listed under FOR FURTHER INFORMATION CONTACT in the document you are interested in. 4. Revise § 11.35 section heading to read as follows: § 11.35 Does FAA include sensitive security information and proprietary information in the Federal Docket Management System (FDMS)? 5. Amend § 11.45 by revising paragraph
(a)introductory text, (a)(1), (a)(2), and
(c)to read as follows: § 11.45 Where and when do I file my comments?
(a)Send your comments to the location specified in the rulemaking document on which you are commenting. If you are asked to send your comments to the Federal Document Management System, you may send them in either of the following ways:
(1)By mail to: U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590.
(2)Through the Internet to *http://www.regulations.gov.*
(c)We may reject your paper or electronic comments if they are frivolous, abusive, or repetitious. We may reject comments you file electronically if you do not follow the electronic filing instructions at the Federal Docket Management System Web site. 6. Amend § 11.63 by revising paragraphs (a)(2), (b)(1), and (b)(2) to read as follows: § 11.63 How and to whom do I submit my petition for rulemaking or petition for exemption?
(a)* * *
(2)To the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590 or to this Internet address: *http://www.regulations.gov.*
(b)* * *
(1)By paper submission, send the original signed copy of your petition for rulemaking or exemption to this address: U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590.
(2)By electronic submission, submit your petition for rulemaking or exemption to FAA through the Internet using the Federal Document Management System Web site at *http://www.regulations.gov.* PART 13—INVESTIGATIVE AND ENFORCEMENT PROCEDURES 7. The authority citation for part 13 continues to read as follows: Authority: 18 U.S.C. 6002; 28 U.S.C. 2461 (note); 49 U.S.C. 106(g), 5121-5124, 40113-40114, 44103-44106, 44702-44703, 44709-44710, 44713, 46101-46110, 46301-46316, 46318, 46501-46502, 46504-46507, 47106, 47111, 47122, 47306, 47531-47532; 49 CFR 1.47. 8. Amend § 13.210 by revising paragraph (e)(1) to read as follows: § 13.210 Filing of documents.
(e)*Internet accessibility of documents filed in the Hearing Docket.*
(1)Unless protected from public disclosure by an order of the ALJ under § 13.226, all documents filed in the Hearing Docket are accessible through the Federal Docket Management System (FDMS): *http://www.regulations.gov.* To access a particular case file, use the FDMS number assigned to the case. 9. Amend § 13.230 by revising paragraph
(b)to read as follows: § 13.230 Record.
(b)*Examination and copying of record.* Any person may examine the record at the Hearing Docket, Federal Aviation Administration, 600 Independence Avenue, SW., Wilbur Wright Building—Room 2014, Washington, DC 20591. Documents may also be examined and copied at the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. Any person may have a copy of the record after payment of reasonable costs to copy the record. PART 17—PROCEDURES FOR PROTESTS AND CONTRACTS DISPUTES 10. The authority citation for part 17 continues to read as follows: Authority: 5 U.S.C. 570-581, 49 U.S.C. 106(f)(2), 40110, 40111, 40112, 46102, 46014, 46105, 46109, and 46110. 11. Amend § 17.15 by revising paragraph (b)(1) to read as follows: § 17.15 Filing a protest.
(b)* * *
(1)Office of Dispute Resolution for Acquisition, Federal Aviation Administration, AGC-70, 3rd Floor, 800 Independence Avenue, SW., Washington, DC 20591, telephone:
(202)267-3290, facsimile:
(202)267-3720; or 12. Amend § 17.25 by revising paragraph (b)(1) to read as follows: § 17.25 Filing a contract dispute.
(b)* * *
(1)Office of Dispute Resolution for Acquisition, Federal Aviation Administration, AGC-70, 3rd Floor, 800 Independence Avenue, SW., Washington, DC 20591, telephone:
(202)267-3290, facsimile:
(202)267-3720; or 13. Amend § 17.27 by revising paragraph (c)(1) to read as follows: § 17.27 Submission of joint or separate statements.
(c)* * *
(1)Office of Dispute Resolution for Acquisition, Federal Aviation Administration, AGC-70, 3rd Floor, 800 Independence Avenue, SW., Washington, DC 20591, telephone:
(202)267-3290, facsimile:
(202)267-3720; or PART 36—NOISE STANDARDS: AIRCRAFT TYPE AND AIRWORTHINESS CERTIFICATION 14. The authority citation for part 36 continues to read as follows: Authority: 42 U.S.C. 4321, *et seq.* ; 49 U.S.C. 106(g), 40113, 44701-44702, 44704, 44715; sec. 305, Pub. L. 96-193, 94 Stat. 50, 57; E.O. 11514, 35 FR 4247, 3 CFR, 1966-1970 Comp., P. 902. 15. Amend § 36.6 by revising paragraph (e)(1) to read as follows, removing paragraph (e)(2), and redesignating paragraphs (e)(3) and (e)(4) as paragraphs (e)(2) and (e)(3) respectively: § 36.6 Incorporation by reference.
(e)* * *
(1)U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. PART 91—GENERAL OPERATING AND FLIGHT RULES 16. The authority citation for part 91 continues to read as follows: Authority: 49 U.S.C. 106(g), 1155, 40103, 40113, 40120, 44101, 44111, 44701, 44704, 44709, 44711, 44712, 44715, 44716, 44717, 44722, 46306, 46315, 46316, 46504, 46506-46507, 47122, 47508, 47528-47531, articles 12 and 29 of the Convention on International Civil Aviation (61 Stat. 1180). 17. Amend § 91.851 by revising the definition of *Chapter 4 noise level* to read as follows: § 91.851 Definitions. *Chapter 4 noise level* means a noise level at or below the maximum noise level prescribed in Chapter 4, Paragraph 4.4, Maximum Noise Levels, of the International Civil Aviation Organization
(ICAO)Annex 16, Volume I, Amendment 7, effective March 21, 2002. The Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 approved the incorporation by reference of this document, which can be obtained from the International Civil Aviation Organization (ICAO), Document Sales Unit, 999 University Street, Montreal, Quebec H3C 5H7, Canada. Also, you may obtain documents on the Internet at *http://www.ICAO.int/eshop/index.cfm.* Copies may be reviewed at the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590 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* . PART 139—CERTIFICATION OF AIRPORTS 18. The authority citation for part 139 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701-44706, 44709, 44719. 19. Amend § 139.111 by revising paragraph (c)(2) to read as follows: § 139.111 Exemptions.
(c)* * *
(2)Federal Docket Management System, as specified under 14 CFR part 11. PART 150—AIRPORT NOISE COMPATIBILITY PLANNING 20. The authority citation for part 150 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44715, 47101, 47501-47504. § 150.13 [Amended] 21. Amend § 150.13 by removing paragraph (e)(2) and redesignating paragraphs (e)(3) and (e)(4) as (e)(2) and (e)(3), respectively. PART 193—PROTECTION OF VOLUNTARILY SUBMITTED INFORMATION 22. The authority citation for part 193 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 40123. 23. Amend § 193.11 by revising the first sentence in paragraph
(a)to read as follows: § 193.11 What is the notice procedure?
(a)*Application.* You may apply to have information designated as protected under this part by submitting an application addressed to the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590 for paper submissions, and the Federal Docket Management System
(FDMS)Web page at *http://www.regulations.gov* for electronic submissions.* * * PART 404—REGULATIONS AND LICENSING REQUIREMENTS 24. The authority citation for part 404 continues to read as follows: Authority: 49 U.S.C. 70101-70121. 25. Amend § 404.3 by revising paragraph (b)(1)(ii) to read as follows: § 404.3 Filing of petitions to the Associate Administrator.
(b)* * *
(ii)Be submitted in duplicate to the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590; PART 406—INVESTIGATIONS, ENFORCEMENT, AND ADMINISTRATIVE REVIEW 26. The authority citation for part 406 continues to read as follows: Authority: 49 U.S.C. 70101-70121. 27. Amend § 406.9 by revising paragraph (g)(1) to read as follows: § 406.9 Civil penalties.
(g)* * *
(1)The respondent must file a written request for hearing with the Federal Docket Management System (U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590) and must serve a copy of the request on the agency attorney. Sections 406.113 and 406.115 state how filing and service must be done. 28. Amend § 406.109 by revising paragraphs (b)(1), (b)(2), and (b)(3) to read as follows: § 406.109 Administrative law judges—powers and limitations.
(b)* * *
(1)The administrative law judge must file with the FDMS, or instruct the party to file with the FDMS, a copy of each document that is submitted to the administrative law judge that has not bee filed with FDMS, except the portions of those documents that contain confidential information.
(2)The administrative law judge must file with the FDMS a copy of each ruling and order issued by the administrative law judge, except those portions that contain confidential information.
(3)The administrative law judge must file with the FDMS, or instruct the court reporter to file with the FDMS, a copy of each transcript and exhibit, except those portions that contain confidential information. 29. Amend § 406.113 by revising paragraphs (a), (b), (c),
(d)introductory text, (d)(1), (d)(2), (e), (f)(1), (f)(2), and (f)(3) to read as follows: § 406.113 Filing documents with the Federal Docket Management System
(FDMS)and sending documents to the administrative law judge and Assistant Chief Counsel for Litigation.
(a)*The Federal Docket Management System (FDMS).*
(1)Documents filed in a civil penalty adjudication are kept in the Federal Docket Management System (FDMS), except for documents that contain confidential information in accordance with § 406.117. The FDMS is an electronic docket. Documents that are filed are scanned into the electronic docket and an index is made of all documents that have been filed so that any person may view the index and documents as provided in paragraph
(f)of this section.
(2)A party is not required to file written interrogatories and responses, requests for production of documents or tangible items and responses, and requests for admission and responses with the Federal Docket Management System or submit them to administrative law judge, except as provided in § 406.143.
(b)*Method of filing.* A person filing a document must mail or personally deliver the signed original and one copy of each document to the FDMS at the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. A person must serve a copy of each document on each party in accordance with § 406.115.
(c)*Date of filing.* The date of filing is the date of personal delivery, or if mailed, the mailing date shown on any certificate of service, the date shown on the postmark if there is no certificate of service, or other mailing data shown by other evidence if there is no certificate of service or postmark. The date shown in the FDMS index is not necessarily the date of service. It is the date the FDMS received the document.
(d)*Form.* FDMS scans the document into its electronic docket. To ensure that FDMS can scan the document and correctly identify it in the index, each person filing a document must comply with the following:
(1)Each document must be legible. It may be handwritten, typewritten, or printed from a computer.
(2)Each document must have a caption on its first page, clearly visible, with the following information:
(i)“FAA Space Adjudication.”
(ii)Case name, such as “In the matter of X Corporation.”
(iii)FAA Case Number and FDMS docket number, if assigned.
(iv)Name of the document being filed, including the party filing the document, such as “Respondent's Motion to Dismiss.”
(v)“Confidential information filed with administrative law judge” or “Confidential information filed with Assistant Chief Counsel for Litigation” if the party is filing confidential information under § 406.117.
(e)*Sending documents to the administrative law judge or Assistant Chief Counsel for Litigation.* Sending the document directly to the administrative law judge or to the Assistant Chief Counsel for Litigation is not a substitute for filing the original with the FDMS, except for confidential information under § 406.117.
(f)* * *
(1)During regular business hours at the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590.
(2)Through the Internet at *http://www.regulations.gov.*
(3)By requesting it from the FDMS and paying reasonable costs. 30. Amend § 406.115 by revising paragraphs (a), (c), and
(d)to read as follows: § 406.115 Serving documents on other parties.
(a)*Service required.* A person must serve on each other party at the time of filing a copy of any document filed with the Federal Docket Management System. Service on a party's attorney or representative of record is adequate service on the party.
(c)*Certificate of service.* A person may attach a certificate of service to a document filed with the FDMS. Any certificate of service must include a statement, dated and signed by the individual filing the document, that the document was served on each party, the method of service, and the date of service.
(d)*Date of service.* The date of service is the date of personal delivery; or if mailed, the mailing date shown on the certificate of service, the date shown on the postmark if there is no certificate of service, or other mailing date shown by other evidence if there is no certificate of service or postmark. The date shown in the FDMS index is not necessarily the date of service. It is the date the FDMS received the document. 31. Amend § 406.121 by revising paragraphs
(a)and
(b)to read as follows: § 406.121 Extension of time.
(a)*Extension of time by agreement of the parties.* The parties may agree to extend for a reasonable period of time for filing a document under this subpart with the agreement of the administrative law judge. The party seeking the extension of time must submit a draft order to the administrative law judge for signature, file it with the Federal Docket Management System, and serve it on each party.
(b)*Motion for extension of time.* If the parties do not agree to an extension of time for filing a document, a party desiring an extension may file with the Federal Docket Management System and serve a written motion for an extension of time not later than 7 days before the document is due unless good cause for the late filing is shown. The administrative law judge may grant the extension of time if good cause for the extension is shown. 32. Amend § 406.127 by revising paragraphs (a)(1) and (b)(3) to read as follows: § 406.127 Complaint and answer in civil penalty adjudications.
(a)*Complaint—(1) Filing.* The complainant must file the original and one copy of the complaint with the Federal Docket Management System, or may file a written motion pursuant to § 406.141(f)(1) instead of filling a complaint, not later than 20 days after receipt by the complainant of a request for hearing. The complainant should suggest a location for the hearing when filing the complaint.
(b)* * *
(3)*Filing and service.* A respondent must file the answer with the Federal Docket Management System and serve a copy of the answer on the agency attorney who filed the complaint. 33. Amend § 406.133 by revising paragraph
(a)introductory text to read as follows: § 406.133 Amendments of pleadings.
(a)*Time.* A party must file with the Federal Docket Management System and serve on each other party any amendment to a complaint or an answer as follows: 34. Amend § 406.137 by revising paragraph
(a)to read as follows: § 406.137 Intervention.
(a)A person may file with the Federal Docket Management System and serve on each other party a motion for leave to intervene as party in an adjudication. Except for good cause shown, a motion for leave to intervene must be filed not later than 10 days before the hearing. 35. Amend § 406.139 by revising paragraphs
(b)introductory text and
(d)to read as follows: § 406.139 Joint procedural or discovery schedule.
(b)*Form and content of schedule.* If the parties agree to a joint procedural or discovery schedule, one of the parties must file with the Federal Docket Management System and serve the joint schedule, setting forth the dates to which the parties have agreed. One of the parties must draft an order establishing a joint schedule for the administrative law judge.
(d)*Order establishing joint schedule.* The administrative law judge must approve the joint schedule filed by the parties by signing the joint schedule and filing it with the Federal Docket Management System. 36. Amend § 406.141 by revising paragraph
(c)to read as follows: § 406.141 Motions.
(c)*Form and time.* Except for oral motions heard on the record, a motion made prior to the hearing must be in writing. Unless otherwise agreed by the parties or for good cause shown, a party must file any prehearing motion with the Federal Docket Management System and serve each other party not later than 30 days before the hearing. 37. Amend § 406.143 by revising the second sentence in paragraph
(b)and by revising the first sentence in paragraph (j)(3) to read as follows: § 406.143 Discovery.
(b)* * * A party is not required to file written interrogatories and responses, requests for production of documents or tangible items and responses, and requests for admission and responses with the Federal Docket Management System or submit any of them to the administrative law judge. * * *
(j)* * *
(3)*Notice of deposition.* A party must serve a notice of deposition, stating the time and place of the deposition and the name and address of each person to be examined, on the person to be deposed, must submit the notice to the administrative law judge, and must file the notice with the Federal Docket Management System, and must serve the notice on each party, not later than 7 days before the deposition. * * * 38. Amend § 406.173 by revising the first and second sentence in paragraph
(d)to read as follows: § 406.173 Interlocutory appeals.
(d)*Procedure.* A party must file with the Federal Docket Management System and serve each other party a notice of interlocutory appeal, with supporting documents, not later than 10 days after the administrative law judge's decision forming the basis of an interlocutory appeal of right or not later than 10 days after the administrative law judge's decision granting an interlocutory appeal for cause. A party must file with the Federal Docket Management System a reply brief, if any, and serve a copy of the reply brief on each party, not later than 10 days after service of the appeal brief. * * * 39. Amend § 406.175 by revising paragraphs (a),
(d)introductory text, and
(e)introductory text, by revising the third sentence in paragraph (f), and by revising paragraph
(g)to read as follows: § 406.175 Appeal from initial decision.
(a)*Notice of appeal.* A party may appeal the initial decision, and any decision not previously appealed pursuant to § 406.173, by filing with the Federal Docket Management System and serving on each party a notice of appeal. A party must file the notice of appeal not later than 10 days after entry of the oral initial decision on the record or service of the written initial decision on the parties.
(d)*Appeal briefs.* A party must file the appeal brief with the Federal Docket Management System and serve each party.
(e)*Reply brief.* Unless otherwise agreed by the parties, any party may file a reply brief with the Federal Docket Management System and serve on each other party not later than 35 days after the appeal brief has been served on that party. If the party relies on evidence contained in the record for the reply, the party must specifically refer to the pertinent evidence contained in the record in the reply brief.
(f)* * * A party may file with the Federal Docket Management System a motion for permission to file an additional brief and must serve a copy of the motion on each other party. * * *
(g)*Number of copies.* A party must file the original brief and two copies of the brief with the Federal Docket Management System and serve one copy on each other party. 40. Amend § 406.177 by revising the second sentence in paragraph
(a)to read as follows: § 406.177 Petition to reconsider or modify a final decision and order of the FAA decisionmaker on appeal.
(a)* * * A party must file a petition to reconsider or modify with the Federal Docket Management System not later than 30 days after service of the FAA decisionmaker's final decision and order on appeal and must serve a copy of the petition on each party. * * * Issued in Washington, DC on November 28, 2007. Pamela Hamilton-Powell, Director, Office of Rulemaking, Aviation Safety. [FR Doc. E7-23422 Filed 12-4-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 520 Oral Dosage Form New Animal Drugs; Carprofen AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Belcher Pharmaceuticals, Inc. The ANADA provides for veterinary prescription use of carprofen caplets in dogs. DATES: This rule is effective December 5, 2007. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: *john.harshman@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Belcher Pharmaceuticals, Inc., 12393 Belcher Rd., Suite 420, Largo, FL 33773, filed ANADA 200-397 for VETPROFEN (carprofen) Caplets. The ANADA provides for veterinary prescription use in dogs for the relief of pain and inflammation associated with osteoarthritis, and for the control of postoperative pain associated with soft tissue and orthopedic surgeries. Belcher Pharmaceuticals, Inc.'s VETPROFEN Caplets are approved as a generic copy of RIMADYL Caplets, sponsored by Pfizer, Inc., under NADA 141-053. The ANADA is approved as of November 7, 2007, and 21 CFR 520.309 is amended to reflect the approval. In addition, Belcher Pharmaceuticals, Inc., has not been previously listed in the animal drug regulations as a sponsor of an approved application. At this time, 21 CFR 510.600(c) is being amended to add entries for the firm. In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Part 520 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and 520 are amended as follows: PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 2. Section 510.600 is amended in the table in paragraph (c)(1) by alphabetically adding a new entry for “Belcher Pharmaceuticals, Inc.” and in the table in paragraph (c)(2) by numerically adding a new entry for “062250” to read as follows: § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.
(c)* * *
(1)* * * Firm name and address Drug labeler code * * * * * Belcher Pharmaceuticals, Inc., 12393 Belcher Rd., suite 420, Largo, FL 33773 062250 * * * * *
(2)* * * Drug labeler code Firm name and address * * * * * 062250 Belcher Pharmaceuticals, Inc., 12393 Belcher Rd., suite 420, Largo, FL 33773 * * * * * PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 520 continues to read as follows: Authority: 21 U.S.C. 360b. § 520.309 [Amended] 4. In paragraph (b)(2) of § 520.309, remove “No. 000115” and add in its place “Nos. 000115 and 062250”. Dated: November 20, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7-23516 Filed 12-4-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs For Use in Animal Feeds; Monensin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending the animal drug regulations to reflect approval of a supplemental new animal drug application
(NADA)filed by Elanco Animal Health. The supplemental NADA revises the concentration of monensin in two-way Type B and Type C medicated feeds containing monensin and tylosin to cattle fed in confinement for slaughter and a revision to bacterial pathogen nomenclature. DATES: This rule is effective December 5, 2007. FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0223, e-mail: *daniel.benz@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 104-646 that provides for use of RUMENSIN (monensin USP) and TYLAN (tylosin phosphate) Type A medicated articles to make dry and liquid two-way combination medicated feeds for cattle fed in confinement for slaughter. The supplemental NADA provides for an increased level of monensin in combination Type B and Type C medicated feeds and a revision to bacterial pathogen nomenclature. The supplemental NADA is approved as of October 30, 2007, and the regulations in 21 CFR 558.355 are amended to reflect the approval. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. The agency has determined under 21 CFR 25.33(a)(2) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor environmental impact statement is required. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is amended as follows: PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: Authority: 21 U.S.C. 360b, 371. 2. In § 558.355, revise paragraphs (f)(3)(ii) and (f)(3)(xii) to read as follows: § 558.355 Monensin.
(f)* * *
(3)* * *
(ii)*Amount per ton* . Monensin, 5 to 40 grams; plus tylosin, 8 to 10 grams. ( *a* ) *Indications for use* . Cattle fed in confinement for slaughter: For improved feed efficiency; and reduction of incidence of liver abscesses caused by *Fusobacterium necrophorum* and *Arcanobacterium (Actinomyces) pyogenes* . ( *b* ) *Limitations* . Feed only to cattle being fed in confinement for slaughter. Feed continuously as sole ration at the rate of 50 to 480 milligrams of monensin and 60 to 90 milligrams of tylosin per head per day. Combination drug liquid Type B medicated feeds may be used to manufacture dry Type C medicated feeds and shall conform to mixing instructions as in § 558.625(c) of this chapter.
(xii)*Amount per ton* . Monensin, 10 to 40 grams; plus tylosin, 8 to 10 grams. ( *a* ) *Indications for use* . Cattle fed in confinement for slaughter: For prevention and control of coccidiosis due to *E. bovis* and *E. zuernii* ; and reduction of incidence of liver abscesses caused by *Fusobacterium necrophorum* and *Arcanobacterium (Actinomyces) pyogenes* . ( *b* ) *Limitations* . Feed only to cattle being fed in confinement for slaughter. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligrams monensin per pound of body weight per day, depending upon the severity of challenge, up to maximum of 480 milligrams per head per day; and 60 to 90 milligrams of tylosin per head per day. Dated: November 20, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7-23519 Filed 12-4-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs For Use in Animal Feeds; Monensin USP AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration
(FDA)is amending the animal drug regulations to reflect approval of a supplemental new animal drug application
(NADA)filed by Elanco Animal Health. The supplemental NADA removes the requirement for 30-day expiration on labeling of monensin Type C medicated feeds for several classes of cattle and goats. DATES: This rule is effective December 5, 2007. FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0223, e-mail: *daniel.benz@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 95-735 that provides for use of RUMENSIN 80 (monensin) Type A medicated articles. The supplement removes the requirement for 30-day expiration on labeling of monensin Type C medicated feeds for several classes of cattle and goats. The supplemental NADA is approved as of November 9, 2007, and the regulations in 21 CFR 558.355 are amended to reflect the approval. In addition, the regulations are being amended to remove a redundant entry for combination use of monensin USP and melengestrol acetate, with or without tylosin phosphate, in medicated feed for heifers fed in confinement for slaughter. This action is being taken to improve the clarity of the regulations. Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required. The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor environmental impact statement is required. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is amended as follows: PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: Authority: 21 U.S.C. 360b, 371. 2. In § 558.355, remove and reserve paragraphs (d)(2), (d)(3), and (f)(3)(viii); and revise paragraph (f)(6)(i)( *b* )( *1* ) to read as follows: § 558.355 Monensin.
(f)* * *
(6)* * *
(i)* * * ( *b* ) * * * ( *1* ) *Feed continuously* . Feed only to goats being fed in confinement. Do not feed to lactating goats. Type C feeds may be manufactured from monensin liquid Type B feeds. The liquid Type B feeds have a pH of 4.3 to 7.1 and their labels must bear appropriate mixing directions, as defined in paragraph (d)(12) of this section. See special labeling considerations in paragraph
(d)of this section. Dated: November 20, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7-23517 Filed 12-4-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF TRANSPORTATION Federal Highway Administration 23 CFR Part 630 [FHWA Docket No. FHWA-2006-25203] RIN 2125-AF10 Temporary Traffic Control Devices AGENCY: Federal Highway Administration (FHWA), DOT. ACTION: Final rule. SUMMARY: The FHWA is adding a new Subpart K to 23 CFR part 630 to supplement existing regulations that govern work zone safety and mobility in highway and street work zones to include conditions for the appropriate use of, and expenditure of funds for, uniformed law enforcement officers, positive protective measures between workers and motorized traffic, and installation and maintenance of temporary traffic control devices during construction, utility, and maintenance operations. These regulations are intended to decrease the likelihood of fatalities and injuries to road users, and to workers who are exposed to motorized traffic (vehicles using the highway for purposes of travel) while working on Federal-aid highway projects. The regulations are issued in accordance with section 1110 of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU), Public Law 109-59, 119 Stat. 1227, codified at 23 U.S.C. 109(e) and 112(g). DATES: *Effective Date:* December 4, 2008. The incorporation by reference of certain publications listed in this rule is approved by the Director of the Federal Register as of December 4, 2008. FOR FURTHER INFORMATION CONTACT: Mr. Chung Eng, Office of Transportation Operations, HOTO-1,
(202)366-8043; or Mr. Raymond W. Cuprill, Office of the Chief Counsel, HCC-30,
(202)366-0791, U.S. Department of Transportation, Federal Highway Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590. Office hours are from 7:45 a.m. to 4:15 p.m., e.t., Monday through Friday, except Federal holidays. SUPPLEMENTARY INFORMATION: Electronic Access This document, the notice of proposed rulemaking (NPRM), and all comments received may be viewed online through the Federal eRulemaking portal at: *http://www.regulations.gov.* The Web site is available 24 hours each day, 365 days each year. Electronic submission and retrieval help and guidelines are available under the help section of the Web site. An electronic copy of this document may also be downloaded from the Office of the **Federal Register** 's home page at: *http://www.archives.gov* and the Government Printing Office's Web page at: *http://www.access.gpo.gov/nara.* Background History In 2004, the FHWA published a final rule updating its regulations on Work Zone Safety and Mobility (23 CFR 630, subpart J). Section 630.1006 of subpart J (Work Zone Safety and Mobility Policy) stated that “Each State shall implement a policy for the systematic consideration and management of work zone impacts on all Federal-aid highway projects. This policy shall address work zone impacts throughout the various stages of the project development and implementation process. This policy may take the form of processes, procedures, and/or guidance, and may vary based on the characteristics and expected work zone impacts of individual projects or classes of projects. The States should institute this policy using a multidisciplinary team and in partnership with the FHWA. The States are encouraged to implement this policy for non-Federal-aid projects as well.” This final rule on Temporary Traffic Control Devices provides additional guidance on the development of such Work Zone Safety and Mobility Policies, and specifically addresses the requirements of section 1110 of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU), Public Law 109-59, 119 Stat. 1227, which have been codified at 23 U.S.C. 109(e) and 112(g). Section 109(e)(2) of title 23, United States Code, states that no funds shall be approved for expenditure on any Federal-aid highway “unless proper temporary traffic control devices to improve safety in work zones will be installed and maintained during construction, utility, and maintenance operations on that portion of the highway with respect to which such expenditures are to be made. Installation and maintenance of the devices shall be in accordance with the Manual on Uniform Traffic Control Devices.” Additionally, section 112(g)(1) requires that “[t]he Secretary, after consultation with appropriate Federal and State officials, shall issue regulations establishing the conditions for the appropriate use of, and expenditure of funds for, uniformed law enforcement officers, positive protective measures between workers and motorized traffic, and installation and maintenance of temporary traffic control devices during construction, utility, and maintenance operations.” A NPRM proposing the creation of a new Subpart K of 23 CFR part 630 was published on November 1, 2006, at 71 FR 64173. The purpose was to emphasize the need to appropriately consider and manage worker safety as part of the project development process by providing guidance on key factors to consider in reducing worker exposure and risk from motorized traffic. The FHWA proposed to require that each agency's policy for the systematic consideration and management of work zone impacts be established in accordance with the recently updated 23 CFR part 630 subpart J (effective October 12, 2007), and address the consideration and management of worker safety as follows: 1. Avoid or minimize worker exposure to motorized traffic through the application of appropriate positive protective strategies including, but not limited to, full road closures; ramp closures; crossovers; detours; and rolling road blocks during work zone setup and removal; 2. Where exposure cannot be adequately managed through the application of the above strategies, reduce risk to workers from being struck by motorized traffic through the use of appropriate positive protective devices; 3. Where exposure and risk reduction is not adequate, possible, or practical, manage risk through the application of appropriate intrusion countermeasures including, but not limited to, the use of uniformed law enforcement officers; and 4. Assure that the quality and adequacy of deployed temporary traffic control devices are maintained for the project duration. The FHWA received a substantial number of comments in response to the NPRM. On December 19, 2006, at 71 FR 75898, the comment period was extended to February 16, 2007, in response to a concern expressed by the National Committee on Uniform Traffic Control Devices (NCUTCD) that the closing date did not provide sufficient time for discussion of the issues in committee and a subsequent comprehensive response to the docket. The extension provided the NCUTCD and other interested parties additional time to discuss, evaluate, and submit comments to the docket. A major focus of the comments to the rule as proposed was the need for greater flexibility in selecting and applying the specific strategies advanced for the required policies and procedures. There was also a general interest in providing a balance between the need for ensuring the safety of construction and maintenance workers as they carry out their tasks in work zones, and the safety of road users as they traverse highway work zones. In developing this final rule the FHWA has carefully considered the comments and suggestions of respondents. Some changes have been made to the overall structure of the rule in order to enhance the clarity and consistency of each section. Other changes have been made to revise the terminology, making it more consistent with the stated intent of section 1110 of SAFETEA-LU, and adjusting the language to clarify the rule's intent. Among the key issues addressed in the development of this final rule were the following: • Revisions to terms and definitions to address all treatments and traffic control devices; • Presentation of treatments as options, not in priority order; • Provision of appropriate pay items for all traffic control treatments and operations; • Flexibility on pay items, acknowledging that either lump sum or unit pricing may be appropriate, depending upon circumstances; and • Reference to the need to manage risks associated with work vehicles and equipment when they are exiting or entering travel lanes. Summary Discussion of Comments Received in Response to the NPRM The following discussion provides an overview of the comments received in response to the NPRM, and the FHWA's actions to resolve and address the issues raised by the respondents. Profile of Respondents Comments were submitted by a broad cross-section of organizations and individuals, including national organizations representing the interests of State departments of transportation and contractors, respectively; other industry groups representing manufacturers and suppliers of highway construction safety equipment; State and local departments of transportation and public authorities; and law enforcement agencies, as well as private consultants and other individuals. The trade associations providing comments were the Associated General Contractors
(AGC)of America; the Association of Road and Transportation Builders of America (ARTBA); the Laborers' Health and Safety Fund of North America (LHSFNA) and the New Jersey State Laborers Health and Safety Fund (NJSLHSF); the NCUTCD; the American Traffic Safety Services Association (ATSSA); the Water Barrier Manufacturers' Association (WBMA); the American Highway Users' Alliance (AHUA); the National Association of County Engineers (NACE); Advocates for Highway and Auto Safety (AHAS); the Maryland Highway Contractors Association (MHCA); and the Colorado Association of Traffic Control Professionals (CATCP). FHWA categorized the comments of the American Association of State Highway and Transportation Officials (AASHTO) with those of State Departments of Transportation (DOTs), because AASHTO represents State DOTs. The AASHTO comments noted that their submission was a consolidated response to the NPRM on behalf of its member States. Many State DOTs provided additional comments individually. Overall Position of Respondents Taken as a whole, the responses to the NPRM were supportive of the intent of the rule, noting the vulnerability of highway workers in work zones and the need to reduce work zone hazards to workers and road users alike. Some respondents thought that the rule as proposed went too far in imposing requirements on agencies undertaking highway construction projects, while others felt that the rule as proposed did not go far enough in protecting workers. In all, there were 80 entries into the docket for comments on the proposed rule. Of these entries, 4 were posted by FHWA (the proposed rule, two background documents providing supporting information to respondents, and a notice extending the comment period for the NPRM). An additional three comments were requests for an extension of the comment period. Thirteen entries into the docket were duplicates of previous entries, or comments that were substantially the same but provided some additional information in support of the comments. Of the 60 remaining responses to the NPRM, 29 respondents supported the proposed rule; in general, these respondents supported the rule as proposed and agreed with the overall purpose, structure, and language, though their comments may have included specific recommendations for clarification or revisions. Another 27 respondents indicated opposition to the NPRM. These respondents generally opposed the rule as proposed; most of these respondents agreed with the overall purpose of the proposed rule, but may have opposed the structure and language of the NPRM (e.g., most State DOTs agreed with the intent of the rule, but disagreed with some specific language). Other respondents may have been neutral toward the rule as a whole, but had some specific recommendations for changes. Most respondents restricted their comments to the proposed regulatory language. However, some addressed material contained in the preamble. One respondent suggested that the approach described in the NPRM would have the potential for increased congestion, inconvenience, and increased travel time and cost to deliver goods and services, which would seem inconsistent with the goals set forth in the National Strategy to Reduce Congestion on America's Transportation Network, and that project characteristics, system capacity, and mobility needs may dictate other approaches. FHWA concurs with the comments that safety measures should be implemented on the basis of project characteristics and that agencies should take into consideration the possible impacts of such measures on system capacity and mobility. However, FHWA feels that the final rule provides sufficient flexibility for operating agencies to select measures that will provide an appropriate level of protection both to road users and to workers in work zone activity areas, while maintaining adequate levels of mobility. Section-by-Section Analysis of the NPRM Comments and FHWA Response Because of the restructuring of the rule in response to FHWA's review of the comments received, the numbering of sections in the final rule is not entirely consistent with the proposed rule. Therefore, comments will be addressed below as they relate to the applicable section of the final rule. Section 630.1102 Purpose Most State DOTs agreed in general terms with the purpose as written. Twenty State DOTs (out of 26 submitting comments) explicitly endorsed AASHTO's response, which included suggested changes to the language. Among AASHTO's suggestions was that the purpose recognize that road user safety should not be compromised by the implementation of any of the rule's requirements. The Maryland State Highway Administration
(SHA)noted that the “section-by-section” discussion in the NPRM for the “Purpose” section says, “[b]y emphasizing worker safety, the proposed rule would attempt to enhance the safety of both the motorist and worker during the project.” However, the SHA felt that the proposed rule seems to be tilted in favor of worker safety, and the balance between the safety of workers and those of the traveling public has not been attained. The FHWA agrees that the objective is to ensure both worker and road user safety. In emphasizing worker safety in the purpose of the proposed rule, the FHWA attempted to provide a better balance between consideration of the safety of workers and those of the traveling public. The FHWA recognizes that the safety of both workers and road users are equally important and has revised the purpose to clearly reflect that this regulation is intended to improve work zone safety for workers and road users alike. AASHTO's comments also proposed that the final rule should not apply to “all State and local highway agencies that receive Federal-aid highway funding,” but rather make the rule applicable to all “Federal-aid projects.” AASHTO also suggested that the FHWA consider including a statement encouraging States to implement these requirements on non-Federal-aid projects as well. In the proposed rule, the first and second sentences under “Purpose” were meant to be taken together, thus indicating applicability to Federal-aid highway projects and recipients of Federal-aid highway funding. The language in the purpose section has been clarified to indicate that this final rule applies only to Federal-aid projects. Language has also been added to encourage application of this rule to non-Federal-aid projects as well. One respondent argued that a primary intent of the rule is to get State DOTs and other agencies to ensure adequate funding to promote worker and road user safety in the work zone planning and design process. While acknowledging that FHWA and the Occupational Safety and Health Administration
(OSHA)have different responsibilities, the respondent suggested that this rule should “strike a common ground between the two.” The respondent went on to urge that FHWA take a more expansive view of worker safety, addressing safety within the work space as well as the interface between workers and motorized traffic. Another respondent suggested that the purpose statement should be changed to “establish requirements and provide guidance for addressing worker safety by limiting the exposure to hazards and risks inside the work zone as well as to hazards and risks from motorized traffic.” This change would expand the scope of the rule to include worker safety inside the work zone, whether or not there is an intrusion. In response to the comments regarding worker safety from hazards and risks inside the work area, the FHWA agrees that worker safety related to internal operations is important, but believes that workplace safety requirements are outside the scope of this rulemaking effort and this subpart, and fall under the purview of OSHA. Some respondents observed that the proposed rule would require changes to the Manual on Uniform Traffic Control Devices (MUTCD). The FHWA agrees that some of the provisions included in the regulation may be appropriate for consideration to be added to the MUTCD; the criteria and provisions for positive protection and law enforcement are, for the most part, good information that can be made more readily available by adding it as guidance or support to the MUTCD. Inclusion of such provisions in the MUTCD may be addressed by the FHWA in a separate and future rulemaking action. Section 630.1104 Definitions The FHWA made several changes to the terms used throughout the final rule to clarify the meaning of the term “positive protective measures.” Changes have been made to the structure of the rule and definitions to strengthen and clarify the intent of the rule, based on the statutory language. One respondent suggested that all definitions should be consistent with existing definitions in the MUTCD, while at the same time ensuring that new terms are not so similar to existing terms as to cause confusion. It was also suggested that any term not in the current MUTCD should be included in the next MUTCD. The FHWA generally agrees, and inclusion of appropriate terminology in the MUTCD may be addressed in a separate and future rulemaking action. In reference to a term used elsewhere in the proposed rule, a respondent suggested that “[t]he term `live travel lane' as referenced in section 630.1106 should be defined under this section.” This wording has been revised in the final rule, now under section 630.1108, to read “travel lanes open to traffic” to better convey its meaning and as a result, the FHWA does not believe a definition is now required. The terms appearing in the final rule are discussed below: Agency. The definition for “Agency” was revised to include public authorities. Exposure Control Measures. This definition was added to address concerns expressed by a number of respondents that terms as presented in the NPRM were somewhat confusing and potentially misleading. “Exposure Control Measures” was added in place of “Positive Protective Strategies” to reflect the fact that strategies were not aimed solely at preventing vehicles from entering the work space, but to reduce worker and road user exposure through a variety of strategies. Federal-aid Highway Project. This definition was left unchanged. Motorized Traffic. This definition was modified to clarify the reference to “construction or maintenance vehicles and equipment,” and to emphasize that, while protection of workers and road users is equally important, the strategies used to address road users may be different from strategies primarily affecting construction vehicles and equipment, particularly when they are entering or exiting the protected area of the work zone. We declined to accept a comment suggesting that the term “motorized traffic” be expanded to include work vehicles in favor of describing in more detail the need to draw distinctions between vehicles passing through the work zone and vehicles operating within the work zone and its protected areas. Other Traffic Control Measures. This definition was added to reflect structural changes in the rule that changed the nomenclature for different activities, and to underscore the distinction between the “exposure control measures,” “positive protection devices,” and any other strategies used to improve worker safety. The term “Intrusion Countermeasures” was eliminated because the measures listed were broader than simply reducing intrusion risk, and the term “Other Traffic Control Measures” is more descriptive of these measures. Positive Protection Devices. A minor change in the wording was made to clarify that such devices may either contain or redirect vehicles, or perform both functions. The FHWA agrees that the term “contain and redirect” may be confusing, because some devices do not redirect impacting vehicles. Many types of crash cushions and arrestor nets contain vehicles, but do not redirect. The terms “Positive Protective Strategies” and “Positive Protective Measures” were eliminated, based on the potential confusion involved in using three closely related terms with different meanings. While 23 U.S.C. 112(g)(4) refers to “Positive Protective Measures,” the FHWA felt that the intent would be best served by using somewhat different terminology in the final rule. Work Zone Safety Management. The term “Work Zone Safety Management” was added as an “umbrella” encompassing all actions taken by an agency to ensure the protection of workers and road users in work zones, including the development of policies, procedures, and guidelines for individual projects or programs. This term was added to respond to comments that the terminology in the NPRM was ambiguous and inconsistent with both current practice and the language of section 1110 of SAFETEA-LU. Section 630.1106 Policy and Procedures for Work Zone Safety Management Section 630.1106 was reorganized and refined from the proposed rule, largely in response to comments submitted to the docket. Material in the proposed rule was rearranged to separate elements related to overall policies and procedures to be developed by State DOTs from specifics related to particular traffic control strategies and the implementation of work zone safety measures. Subsection
(a)of section 630.1106 describes the nature of the required work zone safety measures and traffic control strategies, and encourages State DOTs to work in partnership with FHWA in developing policies and procedures. This use of the term “partnership” is consistent with existing language in Subpart J—Work Zone Safety and Mobility. Subsection
(b)refers to the MUTCD and the AASHTO Roadside Design Guide
(RDG)as sources of information on work zone safety methods and traffic control strategies, and presents some of the project and highway characteristics and factors that the State DOTs should take into consideration when determining which measures and strategies should be employed. Several respondents to the NPRM were concerned about the specificity of some of the language in the proposed rule, commenting that the proposed rule imposed requirements without any supporting research indicating that the proposed criteria were appropriate. The FHWA acknowledges that there is no definitive research supporting specific criteria. The language in the final rule has been modified to clarify the intent of the rule, which is to require appropriate consideration and management of worker and road user safety when planning highway construction, maintenance, and utility operations. The new language retains and expands the listing, previously located in subsection (a), of some of the characteristics and factors that should be considered when deciding what work zone safety measures should be used, while giving agencies flexibility in determining the criteria and thresholds that would affect decisions about the use of different strategies. A comment relating to the specificity of the proposed rule noted that the original language “contains three specific requirements for the use of longitudinal barrier that cause significant concern, as they are restrictive and will have unintended negative consequences if applied unilaterally to all work zones. These requirements include:
(1)Stationary work zones lasting two weeks or more;
(2)with a design speed of 45 mph or higher; and
(3)where workers are within one-lane-width of a live travel lane.” In specifying these specific thresholds in the proposed rule, the intent was to use them as triggers for requiring an analysis on the need for positive protection devices rather than as direct requirements for the use of positive protection devices. These factors are now part of a more comprehensive set of considerations, and are not characterized as “requirements.” As modified, the final rule still requires consideration of worker and road user safety, but provides more flexibility to agencies along with guidance on the factors that should be taken into account in selecting work zone safety measures. Several respondents expressed concern about the term “project design speed.” The FHWA concurs that “project design speed” is inappropriate. While the intended meaning of this term was the work zone design speed rather the design speed of the completed project, it may still not reflect the actual traffic speeds through the work zone. The language in the final rule has been modified to refer to anticipated traffic speeds through the work zone rather than the project design speed. A respondent to the NPRM observed that “the material in the AASHTO Roadside Design Guide is intended to serve as guidance, not as requirements.” The respondent indicated some discomfort with provisions that seem to suggest that the Guide is to be treated as a specific regulation (e.g., actions shall be “consistent with” or “in accordance with” that Guide). The commenter believes that such wording suggests that FHWA will be determining whether a State has acted in accordance with the Guide, even though the Guide itself is, as FHWA stated, a “resource document.” Language in the final rule has been modified to make clear that guidance included in the AASHTO Roadside Design Guide is not, and should not be construed as a “regulation.” Another respondent expressed concern that the requirements in section 630.1106 are “arbitrary and overly prescriptive.” The respondent believes that States should be required to develop policies that help protect highway worker safety and that they should begin by examining the application of strategies that would avoid or minimize worker exposure, even though in many, if not most cases, these strategies will not be practical. However, the respondent felt that section 630.1106(a) should be “softened,” and that this section should be written more as recommendations rather than as requirements. The FHWA has modified the language in this section to emphasize that States have the flexibility to develop policies and procedures that are appropriate to the circumstances of a given project or program. Subsection
(c)deals with law enforcement, directing State DOTs and other agencies undertaking construction projects with Federal-aid funds to develop a policy addressing the use of uniformed law enforcement on such projects. The policy may consist of processes, procedures, and/or guidance, as appropriate. Overall, there is good support and little or no opposition to the concept of agencies developing a policy for work zone law enforcement. The most significant concerns related to the manner of FHWA involvement in development of the policy, and some of the individual provisions to be included. One respondent argued that the language in the proposed rule, which “states that ‘Each agency in cooperation with FHWA, shall develop a policy * * *’ suggests a possible interpretation of some type of joint authority for FHWA to decide how States utilize and pay for law enforcement. This would lead to FHWA involvement in a State's internal management, which is not appropriate.” In response to this concern, the FHWA changed the term “cooperation” to “partnership.” This is the same terminology currently used in Subpart J. Some respondents expressed concern that the proposed rule would have required operating agencies to take responsibility for an area over which they had no control—that is, the integration of law enforcement with work zone safety measures. Another respondent noted the difficulty of ensuring compliance due to the numerous entities involved in law enforcement, including State law enforcement agencies, sheriff departments in multiple counties, and a host of local agencies. The respondent suggested that the rule should include accommodations with numerous and widespread layers of law enforcement involved in safeguarding their roads. The FHWA recognizes that some highway agencies do not have direct connections to law enforcement agencies. However, the FHWA does not believe that is a valid reason for not developing an agency enforcement policy and procedures as stated in the final rule under section 630.1106(c). The final rule does not impose specific requirements on the use of law enforcement and is not prescriptive. While section 630.1108(e) requires the agency to develop a law enforcement policy, it does not dictate what the policy is to contain. Each operating agency has the flexibility to develop a policy suitable for its situation in consideration of the factors listed. Numerous options can be used to acquire law enforcement services. The rule does not limit the required agency policy to consideration of only the State law enforcement agency. In fact, a number of State highway agencies currently have agreements in place with various local law enforcement agencies as well as State law enforcement agencies. Contractors can hire off-duty officers using contract funds as another alternative. Officer training is one of the issues that need to be addressed when developing whatever inter-agency accords may be needed to implement the agency policy. A number of States have good policies and programs in place for use of law enforcement in work zones. For example, a comment by the California Highway Patrol
(CHP)describes its approach. “California's work zone law enforcement program, the Construction/Maintenance Zone Enhanced Enforcement Program (COZEEP/MAZEEP), is based on CHP policy and interagency agreements between the California Department of Transportation (Caltrans) and the CHP. The current policy and agreements adequately meet the issues addressed in this proposed rulemaking. However, to improve communication and interaction, CHP and Caltrans are currently working toward joint training for CHP officers and Caltrans staff to clarify the roles and responsibilities of Caltrans and CHP at the COZEEP/MAZEEP details.” Section 630.1108 Work Zone Safety Management Measures and Strategies Section 630.1108 is reorganized and refined in this final rule. One comment that was made repeatedly by respondents to the NPRM was that the proposed rule was arbitrary and too prescriptive, and that the proposed rule did not permit State DOTs and other affected agencies to make judgments about which work zone safety measures and traffic control strategies would be most appropriate for a given situation. Respondents generally supported a decision process based on an engineering study including consideration of specific work zone factors and existing guidance in the MUTCD and the RDG. An approach that appears to have support from both agencies and industry is to provide a clear listing of the available options, along with a discussion of the factors and existing guidelines that should be considered. Such an approach would also include the specific requirement that the agency policy developed in response to 23 CFR 630.1006 must address both worker and road user safety, and include consideration of the safety options presented in this final rule. FHWA agrees with these observations and has modified the language in the final rule to better reflect the intent of the rule, which is to require appropriate consideration and management of worker and road user safety when planning highway construction, maintenance, and utility operations, while giving agencies flexibility in determining the criteria and thresholds that would affect decisions about the use of different strategies. Throughout the final rule, many of the proposed “shall” statements were modified to emphasize that the proposed strategies or measures represented the types of actions that should be considered, and to make clear that the suggested actions were not being presented in a prescriptive priority order. Comments from one group of respondents focused on the use of portable concrete barriers
(PCB)as a form of positive protection. The respondents observed that, “According to the Roadside Design Guide, `As with all types of traffic barriers, a median barrier should be installed only if striking the barrier is less severe than the consequences that would result if no barrier existed.' This is due to the fact that the PCB has such high Occupant Risk Values when impacted.” The respondents continued, “Due to the fact that the Occupant Risk Values are much greater when impacting PCB than when impacting water-filled barriers, a significant margin of safety could be made available to the motoring public, if water-filled barriers were utilized in place of PCB.... Based on the serious and fatal injuries to vehicle occupants resulting from a number of crashes involving PCBs, we recommend that language be inserted in this section that would disallow PCBs from being installed on the NHS; or installed only in extreme situations. Instead of PCBs, we recommend that water ballast barriers be used exclusively according to accepted design guidelines and only where needed to shield work zone hazards.” The FHWA does not agree with the comment or the suggested change. The FHWA does not believe that any significant overall advantage exists for water-filled barrier and it offers some disadvantages such as freezing and icing in cold temperatures. As worded, the rule allows agencies to select from any positive protection devices that meet the performance criteria set forth in NCHRP Report 350, “Recommended Procedures for the Safety Performance Evaluation of Highway Features.” Another respondent enumerated other concerns with respect to the use of PCBs as positive protection devices, expressing concern about the impact of strict requirements on primary roadway widening construction in their State. The respondent noted that in general, PCBs are utilized where there is a grade elevation change and where drop-offs (greater than two inches) adjacent to a travel lane are necessary, for a period of longer than one work day or work shift. The respondent felt that a literal reading of the proposed rule would necessitate placement of PCB at all edges of the roadway adjacent to construction activities. The PCB would occupy roadway width normally available for use as part of the adjacent travel lane, reducing the average 24-foot wide road to only 20 feet of available travel area. The respondent indicated that this would eliminate opportunities for simultaneous construction on each side of the roadway. Currently, the agency submitting the comment requires construction of temporary pavement in locations adjacent to temporary concrete barrier wall to maintain 12 foot travel lanes. The requirements proposed in this rule would necessitate the construction of miles of temporary pavement to maintain 12 foot travel lanes. Without the temporary pavement, traffic would be restricted to 10 foot travel lanes with a longitudinal barrier on one side of the roadway. The respondent noted that such conditions could be especially hazardous on roadways with substantial truck traffic. Furthermore, the respondent noted that it would be necessary to install breaks in the temporary concrete barrier wall to maintain driveway access, and each break would require the installation of a portable terminal impact attenuator. The respondent felt that in areas with multiple driveways in close proximity to one another, maintenance of a safe installation of temporary concrete barrier wall would be problematic at best. The FHWA agrees that project characteristics need to be considered in decisions involving the use of barriers and language in the final rule requires that the need for positive protection devices be based on an engineering study. Some respondents commented that the proposed rule did not go far enough, and suggested that the final rule should be strengthened to require minimum work zone safety measures or traffic control measures, based on specific criteria. Others proposed that the final rule should provide a “preference of controls,” beginning with consideration of positive protection strategies, followed by consideration of positive protection devices, and then use of intrusion countermeasures. This runs counter to many other comments, which argued for greater flexibility in selection of appropriate work zone safety measures. FHWA concurs with the respondents who argued that there is no definitive research available to support highly prescriptive criteria for when specific work zone safety measures should be deployed. Neither is there evidence that there should be a rigid hierarchy or preference of controls. Instead, FHWA believes that the types of controls appropriate for any given work zone depend on the circumstances (location, volume and speed of adjacent traffic, availability of escape routes for workers, duration of the construction project) and the characteristics of the construction activity (drop-offs, proximity of workers to travel lanes, etc.). Agencies responsible for the construction project should determine the appropriate traffic control measures either on the basis of an engineering study for the individual project, or based on policies adopted by the agency for certain classes of projects. Traffic control strategies that provide for the safety of both workers and road users may be selected alone or in combination, after considering the characteristics and circumstances of the construction project. One respondent argued that without permanent barriers, most maintenance workers are left unprotected from vehicle intrusions. The respondent expressed a preference that all work should be performed behind a permanent barrier, but acknowledged that this would not be possible. When permanent barriers could not be used, the respondent stated that the following measures should be mandated: Uniformed on-duty law enforcement officers in marked cars; marked law enforcement cars to pace traffic to reduce vehicular speeds adjacent to the work zone; buffer lanes between workers and the traveling public (Interstate highways with posted speed limits 55 mph or greater should have at least one buffer lane, and those in excess of 70 mph should have a minimum of two buffer lanes); water-filled barriers; and light towers around the work area to alert the public of highway work. FHWA does not agree, nor do most of the other commenters, that all work should be performed behind a permanent barrier. This is unrealistic and does not necessarily provide the best overall safety for all concerned. The suggestions of alternative measures that should be mandated would appear arbitrary in many respects and would limit an agency's ability to consider the entire range of safety treatments in order to obtain the best balance of worker and road user safety, mobility, constructability, and cost. Another respondent suggested that FHWA should develop its own guidelines or reference non-proprietary products. The respondent also suggested that State agencies should be required to first look to deploy the most protective devices before being allowed to use a less protective measure. The FHWA strongly supports continued research to develop improved guidelines for application of the various treatments. However, the FHWA believes that such research is most appropriate under the National Cooperative Highway Research Program (NCHRP). In fact, NCHRP just recently released a study on the Design of Construction Work Zones on High-Speed Highways (NCHRP Report 581), which is an excellent example of the kind of emerging research that can guide agencies in designing work zones that will help ensure the safety of both road users and construction or maintenance workers. It appears that by “most protective,” the commenter means temporary traffic barrier. The FHWA does not agree that this should always be the priority. The preferred approach is one that would provide the best overall management of safety, mobility, constructability, and cost. Requiring the highest level of positive protection does not necessarily result in the highest level of any of these objectives. Some respondents provided extensive comments on such issues as the desirability of full road closures, and the need for Federal funding to encourage such actions; requiring “Type I and Type II barricades” in place of plastic or rubber cones and delineators; requiring the use of “pennant flagging or similar durable warning tape” to sequester sections of Portland concrete cement
(PCC)that have been freshly laid; requiring the presence of an ATSSA Work Zone Supervisor-qualified person on projects; and to require training for contractors on the use of rolling road blocks. While some of these comments have merit, they are generally beyond the scope of this rulemaking action. However, it should be noted that Subpart J does require that both the contractor and State DOT designate a person responsible for implementing the project TMP and that said individual be properly trained in accordance with Subpart J. The FHWA agrees with many of the suggestions offered by commenters and has substantially revised section 630.1108 as described below. Section 630.1108(a) requires that agencies undertaking highway construction projects with Federal-aid funding determine the need for positive protection devices on the basis of an engineering study. This responds in part to comments from respondents that the term “engineering analysis” used in the proposed rule was not in common use among State DOTs and other agencies, but that the term “engineering study” is used in the MUTCD and is well-understood by such agencies. It also serves to address the language in 23 U.S.C. § 109(e)(2), which states that the “[i]nstallation and maintenance of the [proper temporary traffic control] devices shall be in accordance with the Manual of Uniform Traffic Control Devices.” Section 630.1108(a) also emphasizes that the conditions enumerated in section 630.1106 should be considered when agencies establish what work zone safety measures should be deployed, and identifies some circumstances under which the use of positive protection measures are required to be considered. In section 630.1108(a), the FHWA also responds to concerns that undertaking an engineering study for every work zone, including situations where routine maintenance of facilities is to be undertaken, would be cost-prohibitive. The final rule notes that an engineering study “may be used to develop positive protection guidelines for the agency, or to determine the measures to be applied on an individual project.” In other words, agencies may establish a policy, supported by an engineering study, that dictates the types of work zone safety measures and traffic control strategies that must be implemented at a minimum for certain types of work. Engineering studies could also be undertaken for a specific project based on characteristics of the project or of the circumstances surrounding the project. Factors to be considered in developing a policy for providing traffic control measures for different types of projects, or that might trigger an engineering study for a particular project, are enumerated in this subsection. Such characteristics and factors include duration of the construction zone, site characteristics that would provide workers no means of escape from motorized traffic (e.g., tunnels, bridges, etc.), operating speeds of traffic in lanes adjacent to the work zone, and other elements. Section 630.1108(b) discusses the use of “Exposure Control Measures.” This term was added in place of “Positive Protective Strategies” to reflect the fact that strategies were not aimed solely at preventing vehicles from entering the work space, but to reduce worker exposure through a variety of strategies. One respondent suggested that the use of the phrase “during work zone set up and removal” following “rolling road blocks” should be clarified to indicate that it only refers to rolling road blocks, and not to the other strategies suggested to minimize worker exposure in the proposed rule. Another respondent suggested adding off-peak or night work as another strategy to be considered. The FHWA agrees with these suggestions. Each suggested strategy has been itemized in the final rule for clarity and night or off-peak work, as well as accelerated construction techniques, have been added as additional strategies. Section 630.1108(c) addresses “Other Traffic Control Measures,” which are designed to reduce the number of work zone crashes or to minimize the risks and consequences of intrusion of motorized vehicles into the work space. Several respondents to the NPRM took exception to the use of the term “Intrusion Countermeasures” in the proposed rule. Several respondents noted that some of the measures or strategies included under the rubric of “Intrusion Countermeasures” did not have anything to do with preventing a vehicle from “intruding” or penetrating barriers into the work space. FHWA has changed the title of this section and the wording to reflect the fact that this class of measures or strategies includes actions that relate to increased driver awareness and alertness in work zones, as well as improvements in worker training, improved worker visibility, and the use of law enforcement personnel. This section clarifies that no single measure or strategy will be effective in all circumstances, and that strategies should be considered in combination in order to provide the maximum protection reasonably available to protect workers and road users alike. With respect to specific measures, respondents expressed various levels of support (or opposition) for several strategies. One respondent encouraged FHWA to “strongly recommend automated speed enforcement rather than merely suggesting it.” Automated speed enforcement is one of the available traffic control measures and is included in the list of strategies for consideration. However, the FHWA recognizes that implementation of this strategy would require legislative action by most States. Another respondent noted that “[a]utomated intrusion alarms present a concern due to problems in linking devices in miles-long, drum-protected work zones.” FHWA agrees that intrusion alarms, like most of the other tools listed, may not be suitable for all situations. However, the wording in section 630.1108(c) simply lists it as a tool that may be considered. Several additional measures were added in response to comments, including public and traveler information, and temporary traffic signals. Section 630.1108(d) provides guidance on the use of law enforcement personnel to increase work zone safety. This subsection emphasizes that, while the use of law enforcement personnel can be effective in increasing driver awareness of work zones and compliance with posted warnings, such law enforcement presence is not a substitute for temporary traffic control devices required by the MUTCD. This subsection describes a number of circumstances under which the use of law enforcement personnel may be appropriate, particularly “on projects with high traffic speeds and volumes, and where the work zone is expected to result in significant disruption to or changes in normal traffic flow patterns.” This subsection also addresses the issue of pay items for law enforcement, as required by 23 U.S.C. 112(g). Language from the proposed rule on Federal-aid participation in costs associated with the provision of law enforcement personnel for work zone safety is retained, including the stipulation that “law enforcement activities that would normally be expected in and around highway problem areas requiring routine or ongoing law enforcement traffic control and enforcement activities” are excluded from eligibility for Federal-aid. Section 630.1108(e) was added to address concerns expressed by a number of respondents to the NPRM noting that there are hazards associated with the entry or exit of construction vehicles and equipment from the protected area of the work zone, whether for delivery of supplies and material or for other purposes. The new section 630.1108(e) acknowledges this situation, which poses risks to both workers and travelers, and states that agency processes, procedures, and/or guidance should “address safe means for work vehicles and equipment to enter and exit traffic lanes and for delivery of construction materials to the work space, based on individual project characteristics and factors.” Section 630.1108(f) addresses the issue of pay items. FHWA strongly supports the concept of providing appropriate payment for all work zone traffic control features needed to address both safety and mobility impacts of a highway project. Most highway agencies (but not all) and contractors also support this concept. However, the real issue is in how best to accomplish this. The FHWA believes that this issue arose because, even at this time, some agencies provide little or no specific payment for work zone safety features, and in extreme cases, provide only minimal information as to what features are required. Any payment provided is either incidental to other items of work, or is grouped into a single item for traffic control. This approach is unacceptable in that conscientious contractors are at a significant disadvantage because they provide more safety, without payment, than other contractors that choose to neglect safety to achieve a cost advantage. This problem gives rise to the frequent complaint of the “lack of a level playing field.” The FHWA believes that this is the issue that the wording in the Federal statute attempts to address, and the final rule requires that payment for work zone traffic control features and operations “shall not be incidental to the contract, or included in payment for other items of work not related to traffic control and safety”. A related concern is that contractors may need to include a “contingency factor” in bids to make sure they cover the costs of safety requirements that are not clearly defined in project plans, specifications, and estimates (PS&Es), thus resulting in higher bid prices. Many agencies include a range of pay items in their project PS&Es that provide adequate payment for traffic control, and provide a range of payment items (both lump sum and unit price) for the various safety features needed. Lump sum and unit price payments represent two different approaches to reimbursing contractors for costs associated with construction activities. In deciding whether to use unit price or lump sum payment methods, agencies generally consider the following: • Unit price payment should be limited to those items where the quantity can either be quantified in advance, or closely controlled by the agency during construction. If the quantity cannot be predicted and controlled, it gives rise to the potential for unbalanced bidding. Both agencies and many responsible contractors realize these risks, and do not generally support unit price pay items where quantities cannot be predicted and controlled by the agency. • Lump sum payment reduces the risks of unbalanced bids for features where the actual quantity is dependent upon the manner the contractor selects to accomplish the work. However, to reduce risks to contractors of uncontrolled costs (which may result in higher bids), allowance for contingency payments on lump sum items when the overall quantity or nature of the work changes is desirable and is provided by some agencies. Section 112(g)(2) of title 23, United States Code, requires “separate pay items for the use of uniformed law enforcement officers, positive protective measures between workers and motorized traffic, and installation and maintenance of temporary traffic control devices”, but does not require unit price pay items. In an attempt for clarity, “positive protective measures” was broken down into “positive protective devices” and “positive protective measures” in the proposed rule. The proposed rule addressed payment for positive protective devices and uniformed law enforcement officers, but did not require a separate pay item for the installation and maintenance of temporary traffic control devices because the FHWA felt that doing so would not be substantially different from current practice. Separate payment for positive protective strategies was not specifically addressed in the proposed rule as strategies ultimately translate to devices. Based on comments received and a broader interpretation of the language in section 112(g)(2), the final rule addresses pay items in a more comprehensive fashion by supplementing the requirements of 23 CFR 630.1012(d) with additional requirements as well as guidance. This includes the requirement that separate pay items be provided for major categories of traffic control devices, safety features, and work zone safety activities, including but not limited to positive protection devices, and uniformed law enforcement activities when funded through the project. Section 630.1110 Maintenance of Temporary Traffic Control Devices This section was relatively non-controversial, and retains most of the wording of the proposed rule. One recurring comment is worth mention again here—numerous suggestions called for use of the term “Guidelines” in lieu of “Standards,” as stated in the language of the proposed rule. Some argued that “The term ‘quality standards’ will result in significant liability for State DOTs, leading to the need for constant inspection and maintenance.” After further consideration, and recognizing that the ATSSA reference noted in the NPRM is a guideline, FHWA agrees that the use of the term “guidelines” in lieu of “standards” would be preferable. One comment took exception to the use of the term “assure” in the proposed rule. The respondent contended that use of the term “assure” means to put beyond all doubt, and asserted that maintenance of quality standards to the level of certainty would be cost-prohibitive. The language in the final rule has been revised to eliminate use of the term “assure.” Several comments were made about the use of certain colors on warning signs. The FHWA believes that such recommendations are beyond the scope of the rule and the requirements of section 1110 of SAFETEA-LU. National Congestion Initiative The final rule includes measures that could further the goals of the Secretary of Transportation's National Strategy to Reduce Congestion on America's Transportation Network, announced on May 16, 2006. 1 By requiring the development and implementation of guidelines to help maintain the quality and adequacy of temporary traffic control devices on Federal-aid highway projects, the FHWA anticipates that the proposed rule will help reduce congestion by ensuring that road users are always provided with positive guidance while traveling through work zones. 1 Speaking before the National Retail Federation's annual conference on May 16, 2006, in Washington, DC, former U.S. Transportation Secretary Norman Mineta unveiled a new plan to reduce congestion plaguing America's roads, rail, and airports. The National Strategy to Reduce Congestion on America's Transportation Network includes a number of initiatives designed to reduce transportation congestion. The transcript of these remarks is available at the following URL: *http://www.dot.gov/affairs/minetasp051606.htm* . Rulemaking Analysis and Notices Executive Order 12866 (Regulatory Planning and Review) and U.S. DOT Regulatory Policies and Procedures The FHWA has determined that this action would not be a significant regulatory action within the meaning of Executive Order 12866 or significant within the meaning of U.S. Department of Transportation regulatory policies and procedures. A recent synthesis of positive protection practices in highway work zones indicates that a wide range of positive protection devices and other safety treatments are already being used by State highway agencies. 2 This synthesis found that among positive protection devices, portable concrete barriers and shadow vehicles equipped with truck mounted attenuators (SV/TMAs) were being used by nearly every State highway agency. The final rule emphasizes the need to consider worker and road user safety as an integral part of each State highway agency's process for considering and managing the overall impacts due to work zones. As such, any additional usage of positive protection devices resulting from the proposed action would be incremental to what many State highway agencies are already using to address work zone safety. In addition, consideration of exposure control and other traffic control measures that would avoid or minimize worker exposure to motorized traffic may decrease the overall need for positive protection devices. Accordingly, it is anticipated that the economic impact of this rulemaking would be minimal. 2 Transportation Research Board (TRB), National Cooperative Highway Research Program (NCHRP) Project 20-7(174), A Synthesis of Highway Practice—Positive Protection Practices in Highway Work Zones, June 17, 2005. Available in the docket. The final rule is not anticipated to adversely affect, in a material way, any sector of the economy. In addition, the final rule is not likely to interfere with any action taken or planned by another agency or to materially alter the budgetary impact of any entitlements, grants, user fees, or loan programs. Regulatory Flexibility Act In compliance with the Regulatory Flexibility Act (5 U.S.C. 601-612), the FHWA has evaluated the effects of these changes on small entities. This rule applies to all State and local highway agencies that use Federal-aid highway funding in the execution of their highway program. The final rule emphasizes the need to consider worker and road user safety as an integral part of each agency's process for considering and managing the overall impacts due to work zones on Federal-aid highway projects. As noted previously, a recent synthesis of positive protection practices in highway work zones indicates that a wide range of positive protection devices and other safety treatments are already being used by State highway agencies. This synthesis found that among positive protective devices, portable concrete barriers and SV/TMAs were being used by nearly every State highway agency. The FHWA believes that positive protection devices and other safety treatments are also widely used by many local agencies because the FHWA's research indicates that local agencies usually follow State practice with respect to MUTCD guidance. As such, any additional usage of positive protection devices resulting from the proposed action would be incremental to what many local highway agencies are already using to address work zone safety. In addition, consideration of exposure control and other traffic control measures that would avoid or minimize worker exposure to motorized traffic may decrease the overall need for positive protection devices. Accordingly, the FHWA has determined that the final rule will not have a significant economic impact on a substantial number of small entities. Unfunded Mandates Reform Act of 1995 This final rule would not impose unfunded mandates as defined by the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 109 Stat. 48, March 22, 1995). This action would not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $128.1 million or more in any one year period to comply with these changes. Additionally, the definition of “Federal mandate” in the Unfunded Mandate Reform Act excludes financial assistance of the type in which State, local or tribal governments have authority to adjust their participation in the program in accordance with changes made in the program by the Federal government. The Federal-aid highway program permits this type of flexibility to the States. Executive Order 13132 (Federalism) This action has been analyzed in accordance with the principles and criteria contained in Executive Order 13132 dated August 4, 1999, and the FHWA has determined that this action will not have a substantial direct effect or sufficient federalism implications on States that would limit the policymaking discretion of the States and local governments. The FHWA has also determined that this final rule will not preempt any State law or State regulation or affect the States' ability to discharge traditional State governmental functions and does not have sufficient federalism implications to warrant the preparation of a federalism assessment. The amendments are in keeping with the Secretary of Transportation's authority under 23 U.S.C. 109(d), 315, and 402(a) to promulgate uniform guidelines to promote the safe and efficient use of highways. Executive Order 13175 (Tribal Consultation) The FHWA has analyzed this action under Executive Order 13175, dated November 6, 2000, and believes that it will not have substantial direct effects on one or more Indian tribes; will not impose substantial direct compliance costs on Indian tribal governments; and will not preempt tribal law. The purpose of this final rule is to improve worker and road user safety on Federal-aid highway projects, and will not impose any direct compliance requirements on Indian tribal governments and will not have any economic or other impacts on the viability of Indian tribes. Therefore, a tribal summary impact statement is not required. Executive Order 13211 (Energy Effects) The FHWA has analyzed this action under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. It has been determined that it is not a significant energy action under that order because it is not a significant regulatory action under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects under Executive Order 13211 is not required. Executive Order 12372 (Intergovernmental Review) Catalog of Federal Domestic Assistance Program Number 20.205, Highway Planning and Construction. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities apply to this program. Paperwork Reduction Act Under the Paperwork Reduction Act of 1995
(PRA)(44 U.S.C. 3501, et seq.), Federal agencies must obtain approval from the Office of Management and Budget
(OMB)for each collection of information they conduct, sponsor, or require through regulations. The FHWA has determined that this action does not contain information collection requirements for purposes of the PRA. Executive Order 12988 (Civil Justice Reform) This action meets applicable standards in Sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Executive Order 13045 (Protection of Children) The FHWA has analyzed this action under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. The FHWA certifies that this action would not cause an environmental risk to health or safety that may disproportionately affect children. Executive Order 12630 (Taking of Private Property) This action would not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. National Environmental Policy Act The agency has analyzed this action for the purpose of the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) and has determined that it would not have any effect on the quality of the environment. Regulation Identification Number A regulation identification number
(RIN)is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN contained in the heading of this document can be used to cross-reference this action with the Unified Agenda. List of Subjects in 23 CFR Part 630 Government contracts, Grant programs—Transportation, Highway safety, Highways and roads, Project agreement, Traffic regulations, Incorporation by reference. Issued on: November 29, 2007. J. Richard Capka, Federal Highway Administrator. In consideration of the foregoing, the FHWA adds Subpart K to title 23, Code of Federal Regulations, Part 630, as follows: Subpart K—Temporary Traffic Control Devices Sec. 630.1102 Purpose. 630.1104 Definitions. 630.1106 Policy and Procedures for Work Zone Safety Management. 630.1108 Work Zone Safety Management Measures and Strategies. 630.1110 Maintenance of Temporary Traffic Control Devices. Authority: 23 U.S.C. 109(c) and 112; Sec. 1110 of Pub. L. 109-59; 23 CFR 1.32; and 49 CFR 1.48(b). § 630.1102 Purpose. To decrease the likelihood of highway work zone fatalities and injuries to workers and road users by establishing minimum requirements and providing guidance for the use of positive protection devices between the work space and motorized traffic, installation and maintenance of temporary traffic control devices, and use of uniformed law enforcement officers during construction, utility, and maintenance operations, and by requiring contract pay items to ensure the availability of funds for these provisions. This subpart is applicable to all Federal-aid highway projects, and its application is encouraged on other highway projects as well. § 630.1104 Definitions. For the purposes of this subpart, the following definitions apply: *Agency* means a State or local highway agency or authority that receives Federal-aid highway funding. *Exposure Control Measures* means traffic management strategies to avoid work zone crashes involving workers and motorized traffic by eliminating or reducing traffic through the work zone, or diverting traffic away from the work space. *Federal-aid Highway Project* means highway construction, maintenance, and utility projects funded in whole or in part with Federal-aid funds. *Motorized Traffic* means the motorized traveling public. This term does not include motorized construction or maintenance vehicles and equipment within the work space. *Other Traffic Control Measures* means all strategies and temporary traffic controls other than Positive Protection Devices and Exposure Control Measures, but including uniformed law enforcement officers, used to reduce the risk of work zone crashes involving motorized traffic. *Positive Protection Devices* means devices that contain and/or redirect vehicles and meet the crashworthiness evaluation criteria contained in National Cooperative Highway Research Program (NCHRP) Report 350, Recommended Procedures for the Safety Performance Evaluation of Highway Features, 1993, Transportation Research Board, National Research Council. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. This document is available for inspection and copying at FHWA, 1200 New Jersey Avenue, SE., Washington, DC 20590, as provided in 49 CFR part 7. You may also inspect a copy 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* . *Work Zone Safety Management* means the entire range of traffic management and control and highway safety strategies and devices used to avoid crashes in work zones that can lead to worker and road user injuries and fatalities, including Positive Protection Devices, Exposure Control Measures, and Other Traffic Control Measures. § 630.1106 Policy and Procedures for Work Zone Safety Management.
(a)Each agency's policy and processes, procedures, and/or guidance for the systematic consideration and management of work zone impacts, to be established in accordance with 23 CFR 630.1006, shall include the consideration and management of road user and worker safety on Federal-aid highway projects. These processes, procedures, and/or guidance, to be developed in partnership with the FHWA, shall address the use of Positive Protection Devices to prevent the intrusion of motorized traffic into the work space and other potentially hazardous areas in the work zone; Exposure Control Measures to avoid or minimize worker exposure to motorized traffic and road user exposure to work activities; Other Traffic Control Measures including uniformed law enforcement officers to minimize work zone crashes; and the safe entry/exit of work vehicles onto/from the travel lanes. Each of these strategies should be used to the extent that they are possible, practical, and adequate to manage work zone exposure and reduce the risks of crashes resulting in fatalities or injuries to workers and road users.
(b)Agency processes, procedures, and/or guidance should be based on consideration of standards and/or guidance contained in the Manual on Uniform Traffic Control Devices (MUTCD) and the AASHTO Roadside Design Guide, as well as project characteristics and factors. The strategies and devices to be used may be determined by a project-specific engineering study, or determined from agency guidelines that define strategies and approaches to be used based on project and highway characteristics and factors. The types of measures and strategies to be used are not mutually exclusive, and should be considered in combination as appropriate based on characteristics and factors such as those listed below:
(1)Project scope and duration;
(2)Anticipated traffic speeds through the work zone;
(3)Anticipated traffic volume;
(4)Vehicle mix;
(5)Type of work (as related to worker exposure and crash risks);
(6)Distance between traffic and workers, and extent of worker exposure;
(7)Escape paths available for workers to avoid a vehicle intrusion into the work space;
(8)Time of day (e.g., night work);
(9)Work area restrictions (including impact on worker exposure);
(10)Consequences from/to road users resulting from roadway departure;
(11)Potential hazard to workers and road users presented by device itself and during device placement and removal;
(12)Geometrics that may increase crash risks (e.g., poor sight distance, sharp curves);
(13)Access to/from work space;
(14)Roadway classification; and
(15)Impacts on project cost and duration.
(c)Uniformed Law Enforcement Policy. Each agency, in partnership with the FHWA, shall develop a policy addressing the use of uniformed law enforcement on Federal-aid highway projects. The policy may consist of processes, procedures, and/or guidance. The processes, procedures, and/or guidance should address the following:
(1)Basic interagency agreements between the highway agency and appropriate law enforcement agencies to address work zone enforcement needs;
(2)Interaction between highway and law-enforcement agency during project planning and development;
(3)Conditions where law enforcement involvement in work zone traffic control may be needed or beneficial, and criteria to determine the project-specific need for law enforcement;
(4)General nature of law enforcement services to be provided, and procedures to determine project-specific services;
(5)Appropriate work zone safety and mobility training for the officers, consistent with the training requirements in 23 CFR 630.1008(d);
(6)Procedures for interagency and project-level communications between highway agency and law enforcement personnel; and
(7)Reimbursement agreements for law enforcement service. § 630.1108 Work Zone Safety Management Measures and Strategies.
(a)*Positive Protection Devices.* The need for longitudinal traffic barrier and other positive protection devices shall be based on an engineering study. The engineering study may be used to develop positive protection guidelines for the agency, or to determine the measures to be applied on an individual project. The engineering study should be based on consideration of the factors and characteristics described in section 630.1106(b). At a minimum, positive protection devices shall be considered in work zone situations that place workers at increased risk from motorized traffic, and where positive protection devices offer the highest potential for increased safety for workers and road users, such as:
(1)Work zones that provide workers no means of escape from motorized traffic (e.g., tunnels, bridges, etc.);
(2)Long duration work zones (e.g., two weeks or more) resulting in substantial worker exposure to motorized traffic;
(3)Projects with high anticipated operating speeds (e.g., 45 mph or greater), especially when combined with high traffic volumes;
(4)Work operations that place workers close to travel lanes open to traffic; and
(5)Roadside hazards, such as drop-offs or unfinished bridge decks, that will remain in place overnight or longer.
(b)*Exposure Control Measures.* Exposure Control Measures should be considered where appropriate to avoid or minimize worker exposure to motorized traffic and exposure of road users to work activities, while also providing adequate consideration to the potential impacts on mobility. A wide range of measures may be appropriate for use on individual projects, such as:
(1)Full road closures;
(2)Ramp closures;
(3)Median crossovers;
(4)Full or partial detours or diversions;
(5)Protection of work zone setup and removal operations using rolling road blocks;
(6)Performing work at night or during off-peak periods when traffic volumes are lower; and
(7)Accelerated construction techniques.
(c)*Other Traffic Control Measures.* Other Traffic Control Measures should be given appropriate consideration for use in work zones to reduce work zone crashes and risks and consequences of motorized traffic intrusion into the work space. These measures, which are not mutually exclusive and should be considered in combination as appropriate, include a wide range of other traffic control measures such as:
(1)Effective, credible signing;
(2)Changeable message signs;
(3)Arrow panels;
(4)Warning flags and lights on signs;
(5)Longitudinal and lateral buffer space;
(6)Trained flaggers and spotters;
(7)Enhanced flagger station setups;
(8)Intrusion alarms;
(9)Rumble strips;
(10)Pace or pilot vehicle;
(11)High quality work zone pavement markings and removal of misleading markings;
(12)Channelizing device spacing reduction;
(13)Longitudinal channelizing barricades;
(14)Work zone speed management (including changes to the regulatory speed and/or variable speed limits);
(15)Law enforcement;
(16)Automated speed enforcement (where permitted by State/local laws);
(17)Drone radar;
(18)Worker and work vehicle/equipment visibility;
(19)Worker training;
(20)Public information and traveler information; and
(21)Temporary traffic signals.
(d)*Uniformed Law Enforcement Officers.*
(1)A number of conditions may indicate the need for or benefit of uniformed law enforcement in work zones. The presence of a uniformed law enforcement officer and marked law enforcement vehicle in view of motorized traffic on a highway project can affect driver behavior, helping to maintain appropriate speeds and improve driver alertness through the work zone. However, such law enforcement presence is not a substitute for the temporary traffic control devices required by Part 6 of the MUTCD. In general, the need for law enforcement is greatest on projects with high traffic speeds and volumes, and where the work zone is expected to result in substantial disruption to or changes in normal traffic flow patterns. Specific project conditions should be examined to determine the need for or potential benefit of law enforcement, such as the following:
(i)Frequent worker presence adjacent to high-speed traffic without positive protection devices;
(ii)Traffic control setup or removal that presents significant risks to workers and road users;
(iii)Complex or very short term changes in traffic patterns with significant potential for road user confusion or worker risk from traffic exposure;
(iv)Night work operations that create substantial traffic safety risks for workers and road users;
(v)Existing traffic conditions and crash histories that indicate a potential for substantial safety and congestion impacts related to the work zone activity, and that may be mitigated by improved driver behavior and awareness of the work zone;
(vi)Work zone operations that require brief stoppage of all traffic in one or both directions;
(vii)High-speed roadways where unexpected or sudden traffic queuing is anticipated, especially if the queue forms a considerable distance in advance of the work zone or immediately adjacent to the work space; and
(viii)Other work site conditions where traffic presents a high risk for workers and road users, such that the risk may be reduced by improving road user behavior and awareness.
(2)Costs associated with the provision of uniformed law enforcement to help protect workers and road users, and to maintain safe and efficient travel through highway work zones, are eligible for Federal-aid participation. Federal-aid eligibility excludes law enforcement activities that would normally be expected in and around highway problem areas requiring routine or ongoing law enforcement traffic control and enforcement activities. Payment for the services of uniformed law enforcement in work zones may be included in the construction contract, or be provided by direct reimbursement from the highway agency to the law enforcement agency. When payment is included through the construction contract, the contractor will be responsible for reimbursing the law enforcement agency, and in turn will recover those costs through contract pay items. Direct interagency reimbursement may be made on a project-specific basis, or on a program-wide basis that considers the overall level of services to be provided by the law enforcement agency. Contract pay items for law enforcement service may be either unit price or lump sum items. Unit price items should be utilized when the highway agency can estimate and control the quantity of law enforcement services required on the project. The use of lump sum payment should be limited to situations where the quantity of services is directly affected by the contractor's choice of project scheduling and chosen manner of staging and performing the work. Innovative payment items may also be considered when they offer an advantage to both the highway agency and the contractor. When reimbursement to the law enforcement agency is made by interagency transfer of funds, the highway agency should establish a program-level or project-level budget that is adequate to meet anticipated program or project needs, and include provisions to address unplanned needs and other contingencies.
(e)*Work Vehicles and Equipment.* In addition to addressing risks to workers and road users from motorized traffic, the agency processes, procedures, and/or guidance established in accordance with 23 CFR 630.1006 should also address safe means for work vehicles and equipment to enter and exit traffic lanes and for delivery of construction materials to the work space, based on individual project characteristics and factors.
(f)*Payment for Traffic Control.* Consistent with the requirements of 23 CFR 630.1012, Project-level Procedures, project plans, specifications and estimates (PS&Es) shall include appropriate pay item provisions for implementing the project Transportation Management Plan (TMP), which includes a Temporary Traffic Control
(TTC)plan, either through method or performance based specifications. Pay item provisions include, but are not limited to, the following:
(1)Payment for work zone traffic control features and operations shall not be incidental to the contract, or included in payment for other items of work not related to traffic control and safety;
(2)As a minimum, separate pay items shall be provided for major categories of traffic control devices, safety features, and work zone safety activities, including but not limited to positive protection devices, and uniformed law enforcement activities when funded through the project;
(3)For method based specifications, the specifications and other PS&E documents should provide sufficient details such that the quantity and types of devices and the overall effort required to implement and maintain the TMP can be determined;
(4)For method-based specifications, unit price pay items, lump sum pay items, or a combination thereof may be used;
(5)Lump sum payment should be limited to items for which an estimate of the actual quantity required is provided in the PS&E or for items where the actual quantity required is dependent upon the contractor's choice of work scheduling and methodology;
(6)For Lump Sum items, a contingency provision should be included such that additional payment is provided if the quantity or nature of the required work changes, either an increase or decrease, due to circumstances beyond the control of the contractor;
(7)Unit price payment should be provided for those items over which the contractor has little or no control over the quantity, and no firm estimate of quantities is provided in the PS&Es, but over which the highway agency has control of the actual quantity to be required during the project;
(8)Specifications should clearly indicate how placement, movement/relocation, and maintenance of traffic control devices and safety features will be compensated; and
(9)The specifications should include provisions to require and enforce contractor compliance with the contract provisions relative to implementation and maintenance of the project TMP and related traffic control items. Enforcement provisions may include remedies such as liquidated damages, work suspensions, or withholding payment for noncompliance. § 630.1110 Maintenance of Temporary Traffic Control Devices. To provide for the continued effectiveness of temporary traffic control devices, each agency shall develop and implement quality guidelines to help maintain the quality and adequacy of the temporary traffic control devices for the duration of the project. Agencies may choose to adopt existing quality guidelines such as those developed by the American Traffic Safety Services Association (ATSSA) or other state highway agencies. 1 A level of inspection necessary to provide ongoing compliance with the quality guidelines shall be provided. 1 The American Traffic Safety Services Association's (ATSSA) Quality Guidelines for Work Zone Traffic Control Devices uses photos and written descriptions to help judge when a traffic control device has outlived its usefulness. These guidelines are available for purchase from ATSSA through the following URL: *http://www.atssa.com/store/bc_item_detail.jsp?productId=1.* Similar guidelines are available from various State highway agencies. The Illinois Department of Transportation “Quality Standards for Work Zone Traffic Control Devices” is available online at *http://dot.state.il.us/workzone/wztcd2004r.pdf* . The Minnesota Department of Transportation “Quality Standards—Methods to determine whether the various traffic control devices are Acceptable, Marginal, or Unacceptable” is available online at *http://www.dot.state.mn.us/trafficeng/otepubl/fieldmanual2007/FM-2007-QualityStandards.pdf* . [FR Doc. E7-23581 Filed 12-4-07; 8:45 am] BILLING CODE 4910-22-P DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs 25 CFR Part 36 RIN 1076-AE51 Homeliving Programs AGENCY: Bureau of Indian Education, BIA, Interior. ACTION: Final Rule. SUMMARY: Under the No Child Left Behind Act of 2001, the Secretary of the Interior is publishing final regulations addressing homeliving programs administered under the Bureau of Indian Education-funded school system. DATES: *Effective Date:* January 4, 2008. FOR FURTHER INFORMATION CONTACT: Kevin Skenandore, Director, Bureau of Indian Education, 1849 C Street NW., MS-3609, Washington, DC 20240, phone
(202)208-6123. SUPPLEMENTARY INFORMATION: I. Background A. What Information Does This Section Address? This section addresses: —Requirements of the No Child Left Behind Act of 2001 (Pub. L. 107-110; enacted January 8, 2002; “NCLBA” or “the Act”), section 1122. —Overview of the negotiated rulemaking process. —How public comments were handled. B. What Are the Negotiated Rulemaking Requirements of the Act? The Secretary of the Interior (“Secretary”) established a negotiated rulemaking committee (Committee) to develop proposed regulations to implement several sections of the Act related to the Bureau of Indian Education (Bureau)-funded school system. The Act required that the committee be comprised only of representatives of the Federal Government and representatives of tribes served by Bureau-funded schools. The Act also required that, to the maximum extent possible, the tribal representative membership reflect the proportionate share of students from tribes served by the Bureau-funded school system. The Secretary chartered the committee under the Federal Advisory Committee Act (5 U.S.C. Appendix (FACA)) on May 1, 2003. The committee was comprised of Federal representatives and representatives of tribes served by Bureau-funded schools who met in February 2006 to negotiate recommendations for proposed regulations under Section 1122 of the Act, 25 CFR part 36, Minimum Academic Standards for the Basic Education of Indian Children and National Criteria for Dormitory Situations. As a basis for negotiations and for consensus, the committee used draft regulations proposed by the Bureau school and residential administrators. C. What Was the Negotiated Rulemaking Process? As required by the No Child Left Behind Act of 2001 (Pub. L. 107-110; enacted January 8, 2002, referred to in this preamble as “NCLB” or “the Act”), the Department of the Interior established a Negotiated Rulemaking Committee to develop proposed rules to implement several sections of the Act relating to the Bureau of Indian Education-funded school system. Negotiated Rulemaking is a process sanctioned by Subchapter III, or Chapter 5, Title 5, United States Code and the Federal Advisory Committee Act, 5 U.S.C. Appendix (FACA), that employs Federal representatives and members of the public who will be affected by rules to jointly develop proposed rules. In this case, the Act required the Secretary of the Interior to select representatives of Indian tribes and Bureau-funded schools as well as Federal Government representatives to serve on the Committee. The Committee's task was to draft proposed rules to recommend to the Secretary. Upon the Secretary's approval, draft rules are published in the **Federal Register** for written public comments within a 120-day public comment period. After the close of the public comment period, the Committee will reconvene to review these comments and to recommend promulgation of final rules to the Secretary. The Secretary chartered the Committee under the FACA on May 1, 2003. It is comprised of 19 members nominated by Indian tribes and tribally operated schools. The law required that, to the maximum extent possible, the tribal representative membership should reflect the proportionate share of students from tribes served by the Bureau-funded school system. The Secretary also appointed to the Committee six members from within the Department of the Interior. The Committee selected three tribal representatives and two Federal representatives as co-chairs. Six individuals were hired to facilitate all Committee meetings. The Committee initially met in the months of June through October 2003 to develop regulations in six areas. Subsequently, the Department reconvened the Committee in February 2004 to develop regulations in the areas of closure and consolidation of schools and criteria for homeliving situations. The Committee met on several occasions and developed the proposed rules that were published on July 12, 2004 (69 FR 41770). D. How Were Public Comments Handled? The Secretary published proposed regulations on July 12, 2004, for public comment. The public comment period ended on November 9, 2004. We received comments on this proposed rule from nine commenters, including tribal leaders, educators, and administrators. We reviewed all comments. Summaries of individual public comments and our responses are noted below. The final regulations are organized, as were the proposed regulations, under three broad categories: homeliving staffing; homeliving programs; and homeliving privacy. The final regulations, published as 25 CFR part 36—Homeliving Situations, reflect the public comments that were accepted. The Department still has under consideration the regulations for school closure and consolidation. At this time, the Department has made no final decision on issuing these rules. II. Public Comments In this section we discuss the main public comments received. General comments are discussed first, followed by comments on specific sections of the rule. Our responses follow each comment. Section 36.70 What Terms do I Need to Know? *Comment:* Several commenters suggested that we clarify or define the term “supplemental services” in § 36.70 and several others suggested that we clarify what “actually receiving supplemental services” means in § 36.70(2)(ii). *Response:* We considered these comments and removed the obsolete reference to “supplemental services.” *Comment:* Several commenters suggested we add definitions for the following terms: “behavioral health programs,” “behavioral health services,” and “behavioral health staff.” *Response:* We accepted the comments and have added definitions for the terms. *Comment:* A commenter recommended clarifying the definitions of “homeliving manager” and “homeliving supervisor” by switching the definitions to more accurately reflect what each position is responsible for. In the alternative, if the manager is to be responsible for physically supervising students, the commenter recommended changing the name of the “homeliving supervisor” to “homeliving administrator.” *Response:* We considered this comment and made no change. Section 36.71 What Is the Purpose of This Part? *Comment:* A commenter recommended changing the definition for “homeliving situation” to: “Any program where education instruction and residential services are provided for students enrolled in Bureau-funded schools, who are housed at a Bureau-funded school facility, and who receive care, before and after school hours, in a manner in which they do not have to depend on family or guardianship.” *Response:* We considered this comment, but, determined no change was necessary. *Comment:* A commenter suggested replacing the term “homeliving situations” with “homeliving programs.” *Response:* We considered the comment and revised § 36.71. Section 36.75 What Qualifications Must Homeliving Staff Possess? *Comment:* A commenter suggested that the competency or professional standards of homeliving personnel should not be compromised in § 36.75. The commenter stated that agreements to operate a quality program with quality staff is between BIE and the tribal governing body and should not be discretionary at the school staff level. The commenter stated that it may be appropriate to waive such qualifications only where the employee is a trainee under the supervision of a fully qualified supervisor, and it is a tribal decision, not a Federal one. *Response:* We considered the comment, but determined that no change was necessary because a tribe can instruct the school supervisor if the school is a tribally operated school. *Comment:* A commenter stated that requirements for improved criteria for homeliving staff in § 36.75 should not be unfunded mandates. The commenter supports a complete overhaul of the current funding formula in order to create a universal therapeutic model in all BIE-funded schools. *Response:* While the Committee was aware of the funding needs for Indian education, the scope of the Committee was to draft regulations to implement the statute. Therefore, while the Committee notes the commenter's general comments about the need for additional funding and different funding priorities, these comments are outside of the scope of the rulemaking. Therefore, we made no change to the regulations. *Comment:* A commenter suggested that substance abuse education and prevention training should be added to required training in § 36.75. *Response:* This is already required in § 36.86(c)(2). *Comment:* A commenter suggested:
(1)that a determination of good cause in § 36.75(b)(2) should be made at the Education Line Officer level,
(2)that guidelines or standards be provided for determining what good cause means, and
(3)that a timeframe for waivers be added. *Response:* We considered the comment and accepted it in part and rejected it in part. We rejected the part of the comment that raised issues the Committee considered in its deliberations. We accepted the part of the comment on adding a timeframe for waivers and revised § 36.75(b)(2). *Comment:* A commenter recommended that in § 36.75 the delay of the effective date for higher standards for homeliving staff apply to current staff as a well as to new hires, and that the effective date depend on the Department's securing additional funding. *Response:* The Committee considered the effective date of the higher standards for homeliving staff. The comment does not raise new issues that the Committee did not consider. Therefore, we considered the comment, but we made no change to the regulations. *Comment:* A commenter suggested changing § 36.75 to allow the homeliving supervisor rather than the “school supervisor” to grant a waiver for a showing of good cause. *Response:* We considered the comment, but we believed the proposed language provides for the entity with decision-making authority to decide whether to grant the waiver. Therefore, we made no change to the regulations. *Comment:* Several commenters suggested that some homeliving program staff may not need the same level of educational standards as others because they work at night when students are sleeping and recommended changing the required standards in § 36.75(a). *Response:* In adopting these regulations, the Committee considered that there are different levels of homeliving program staff. The Committee considered and did not adopt different standards for night-duty. Therefore, we considered the comment, but made no change to the regulations. *Comment:* A commenter recommended that § 36.75 include a certificate program in lieu of the 32-hour post-secondary semester hour requirement since BIE-operated boarding schools are unique. Another commenter suggested that § 36.75 provide for development of a residential certificate of training including at least 80 hours in topics such as child development, behavior management, working with students at risk, special education students, social interaction skills, etc., as an option to requiring 32/48 hours of college credit. The certificate would be updated every 3 years with at least 10 hours of training. A second commenter recommended that distance education and computer modules be available to staff. A third commenter recommended that § 36.75 provide that each facility is responsible to set its own appropriate training requirements to fit its specific needs. This commenter further suggested that requiring 32 hours of post-secondary semester hours in a field related to child development and at least 1 year of relevant experience will cause a drop in the applicant pool and that a degree does not necessarily make an applicant competent for a position. *Response:* We considered these comments and made no changes to the rule. *Comment:* A commenter suggested that if the definitions for “homeliving manager” and “homeliving supervisor” are switched, the qualifications for the two positions should also be switched in § 36.75. *Response:* We considered this comment and made no changes because the definitions were not switched. *Comment:* A commenter recommended deleting § 36.75(b) “when this part is published in final” because it is unnecessary considering the 2009-2010 timeframe and could be interpreted to apply only to those persons employed at the time the rule becomes final. *Response:* We accepted this comment and changed the text to delete the reference to the rule's publication date. *Comment:* A commenter recommended that we clarify § 36.75(b)(2) by stating whether the supervisor empowered to grant waivers from new qualifications has procedural guidance to follow. *Response:* We considered this comment and revised the paragraph to clarify the process. The paragraph now states that a person not meeting the qualifications, “may, upon showing good cause, petition the school supervisor (or the homeliving supervisor for peripheral dorms) for a waiver from the new qualifications.” *Comment:* A commenter stated that:
(1)32 hours of post-secondary semester hours for basic homeliving staff would dramatically reduce the applicant supply pool for those positions at the local level;
(2)We should clarify whether new hires before SY 2009-2010 must meet the new requirements;
(3)Funding should be made available for dormitory programs, for training and post-secondary credit hours for meeting the recommended qualification requirements, and for meeting the needs of the students being served. *Response:* We considered the comment, but did not change the section. While the training requirement may reduce the number of applicants for these positions, dormitory staff must have more training because of new needs children are exhibiting in behavior, new diagnostic findings affecting learning skills, and changes in life styles affecting family concepts and step-parenting, among other issues. *Comment:* A commenter stated that if “recreation staff” is included in “homeliving staff” that fact should be stated and clarified in the definition of “homeliving staff.” *Response:* The committee considered this in its original deliberation and no new issues have been raised by this comment that were not already considered by the committee. Section 36.76 Who Is in Charge of all Homeliving Operations? *Comment:* A commenter stated that the purpose of § 36.76 is unclear. If the section means there will be clear lines of authority, the question should be revised to read: “Must there exist clear lines of authority?” and the answer should read: “Yes, clear lines of authority must be established through the development of an organizational chart approved by the local board * * *” Or, if this section means to make a point other than establishing the requirement that an organizational chart be developed; the section needs to be re-written for clarity. *Response:* We accepted this comment and made corresponding changes to the rule. Section 36.77 What Are the Homeliving Program Staffing Requirements? *Comment:* Several commenters recommended that the delayed implementation of the homeliving staff-to-student ratios to school year 2009-10 in § 36.77 depend on the Department's securing the necessary funding to make the new ratios affordable. *Response:* We considered this comment and revised the section title in response. *Comment:* A commenter suggested that adult-to-child staffing ratios in dormitories for Native American children should be lower than 1:20-30 if other similar programs require lower adult-to-child staffing ratios. *Response:* The Committee considered adult-to-child staffing ratios in drafting the regulations. The Committee discussed the pros and cons of changing staffing ratios and chose to adopt credentialing rather than changing staffing ratios. The comments raise no new issues to consider. Therefore, we made no change to the regulations. *Comment:* A commenter recommended that § 36.77 should state what ratios will be effective until SY 2009-2010. *Response:* We considered this comment, but made no changes to the regulation. *Comment:* A commenter suggested that since § 36.75 requires higher quality staff, § 36.77 should provide that this staff be compensated appropriately, but questioned how positions will be funded if IRG is cut. *Response:* The Committee in its original deliberations considered the impact of these requirements and balanced them with the needs of the students. No new issues are raised by the commenter that were not considered in the original deliberations. Therefore, we made no change to the rule. *Comment:* A commenter suggested that § 36.77 state that existing staff-to-student ratios remain in effect until the new requirements are effective. *Response:* The Committee considered this issue at the time it negotiated the regulations and the comment raises no new issues. Therefore, we made no change to the regulations. *Comment:* A commenter questioned whether it is necessary in § 36.77(b) to have three different staff-to-student ratios on weekends because weekend staff is presumably supervising rather than conducting structured programs. *Response:* The Committee considered this issue at the time it negotiated the regulations and the comment raises no new issues. Therefore, we made no change to the regulations. *Comment:* A commenter recommended revising § 36.77 by revising the question to: “What is the minimum acceptable staffing supervisory requirements necessary to adequately supervise students and provide a safe environment?” and eliminating the introductory sentence. *Response:* We considered this comment and changed the section title to read, “What are the homeliving program staffing requirements?” Section 36.79 What Are the Homeliving Behavioral Staff/Student Ratio Requirements? *Comment:* A commenter suggested that the regulations define the term “behavioral staff.” Another commenter suggested clarifying whether a behavioral health professional is the same as a certified counselor, either school or MSW, in § 36.79. *Response:* We accepted these comments and defined “behavioral staff” at § 36.79. *Comment:* A commenter stated that the regulations at § 36.79(b) change “should” to “must” for providing one full-time behavioral health professional for off-reservation boarding schools. *Response:* We considered the comment, but we did not accept it. This issue was raised during the original Committee deliberations. In order to reach consensus the Committee adopted the provision that the homeliving program “should” consider providing these services. This comment does not raise any new issues that were not considered by the committee when originally discussing this issue. Therefore, we made no change to the regulations. *Comment:* A commenter recommended that § 36.79 be amended to delete a 20-hour minimum. *Response:* We accepted this comment and added new paragraph
(d)in response. *Comment:* A commenter stated that funding increases are necessary to meet the criteria in § 36.79 for the number of and the educational level of behavioral health professionals who are necessary in homeliving programs to address issues such as abuse, neglect, trauma, cultural conflict, and lack of school success. *Response:* Budget-related issues are fully addressed elsewhere in this preamble. *Comment:* A commenter recommended revising § 36.79(b) to state “must,” not “should” so that behavioral health may not be made optional and students who live off-reservation are not deprived of this requirement. *Response:* This issue was raised during the original deliberations and, to reach consensus, the Committee adopted the provision that the homeliving program “should” consider providing these services. This comment does not raise any new issues that were not considered by the Committee when originally discussing this issue. Therefore, the comment is not accepted. Section 36.80 If a School Has Separated Boys' and Girls' Homeliving Programs, May the Same Behavioral Staff Be Used for Each Program? *Comment:* A commenter recommended clarifying the term “homeliving count period” in § 36.80. *Response:* We considered the comment, but we are making no change to the regulations because the homeliving count period is defined in the funding formula regulations at 25 CFR 39. Section 36.81 May a Homeliving Program Use Support Staff or Teachers to Meet Behavioral Health Staffing Requirements? *Comment:* A commenter recommended revising the second sentence in § 36.81 to allow for flexibility in how a residential facility meets the behavioral health staffing requirements. The sentence is recommended to read: “The only exception is if the individual support staff employee or teacher has the appropriate behavioral health license or certification or other appropriate training and supervision.” *Response:* We accepted this comment in part and revised the second sentence to read as follows: “The only exception is if the individual support staff employee or teacher has the appropriate behavioral health license or certification.” *Comment:* A commenter recommended eliminating the exception in § 36.81 or adding a requirement that the individual's contract provide that the teaching and behavioral health services are not to be provided simultaneously. *Response:* We considered this comment in conjunction with other comments on this issue. If teachers have the requisite training, then they may be able to provide the service as long as the provisions of § 36.82 have been met. Therefore, we made no change to the rule. Section 36.82 May Behavioral Health Staff Provide Services During the Academic School Day? *Comment:* A commenter recommended adding a provision for maximizing time the behavioral health staff is working with students during the time students are in the dorms, especially on weekends. Another commenter stated that we should amend § 36.82 to require that behavioral health staff provide services outside the academic school day except in emergencies and provide that schools have the necessary staff to handle emergency situations. The commenter suggested that behavioral health staff may observe students in their academic environment. *Response:* In response to these comments, we revised § 36.82. Section 36.83 How Many Hours Can a Student be Taken Out of the Academic Setting to Receive Behavioral Health Services? *Comment:* A commenter suggested that § 36.83 be clarified so that schools may not use behavioral health staff outside their intended services. *Response:* We considered the comment and addressed the suggested changes in § 32.82. *Comment:* A commenter recommended that we amend § 36.83 to provide that students not be taken out of the academic setting to receive behavioral health services unless it is an emergency and to provide that schools have their own behavioral health professionals. The commenter recommended that Licensed Practicing Counselors not have a caseload of students. Another commenter recommended revising § 36.83 to state: “should not spend more than” rather than “may spend no more than” in order to provide staff the needed flexibility to appropriately address each student's individual needs and provide necessary services. *Response:* We considered these comments and made changes consistent with the other comments on this section. Section 36.84 Can a Program Hire or Contract or Acquire by Other Means Behavioral Health Professionals to Meet Staffing Requirements? *Comment:* A commenter recommended that § 36.84 provide that instructional time be guarded. Each student should be able to go through an initial screening provided by the counselors. *Response:* We considered this comment, but no change to the rule is necessary. *Comment:* A commenter recommended delaying implementation of behavioral staff license requirement until additional appropriations are obtained and recommended revising § 36.84, paragraph
(b)by changing “and” to “or.” *Response:* We accepted this comment and changed the rule. *Comment:* A commenter recommended that more instruction be provided so BIE-operated and grant/contract school programs can strategize with one another to maximize services to students and minimize the cost of services. In some locations distance is a factor and highly qualified people are in extreme demand and few agree to travel long distances and/or agree to provide services to a large number of identified students. Restrictions imposed by preferences of authority hinder meeting the needs of students. Schools must have strong working relationships. *Response:* We revised this section to allow tribes and schools to work together to provide these services to students. Section 36.85 Is a Nurse Required To Be Available in the Evenings? *Comment:* A commenter recommended that we amend § 36.85 to require that nursing staff be on campus not only during the academic hours, but also outside of academic hours because more accidents are going to happen outside of academic hours. Another commenter recommended making the requirement in § 36.85 for having a RN or LPN available in the evenings when enrolment is over 300 mandatory. *Response:* The committee considered the response but rejected it. Section 36.86 Are There Staff Training Requirements? *Comment:* A commenter agreed with the increase in educational requirements for new staff and homeliving managers and supervisors in § 36.86. *Response:* We made no change to § 36.86 because the comment required no change. *Comment:* A commenter stated that in § 36.86 (a)(4) confidentiality should follow the Family Education Right to Privacy Act, not just the Health Information Privacy Act. *Response:* We considered the comment and revised § 36.86(a)(4). *Comment:* A commenter recommended inserting “surrogate” before “parent training” in § 36.86(b)(4) because staff serves as surrogate parents in residential settings. *Response:* We accepted the idea behind the comment and changed § 36.86(b)(4) to read:
(4)Parenting skills/child care. *Comment:* A commenter recommended revising the question in § 36.86 as follows: “Are there homeliving staff training requirements?” *Response:* We considered this comment and revised the section text, but not the title. To be more inclusive, the section states that all homeliving program staff and employees that supervise students participating in homeliving services and activities must have appropriate certification or requirements and receive annual training in specified topics. *Comment:* A commenter suggested that the first paragraph in § 36.86, which applies to training that is “appropriate to the certification and licensing requirements,” is erroneous since none of the required training will result in licensing or certification, except in First Aid or CPR. Homeliving staff is not required to be licensed or certified (§ 36.75). The commenter recommended that this section be revised to provide flexibility so that residential programs may determine the frequency and timing of training as appropriate to their situations, including providing for refresher sessions for returning staff and training that may be completed over a 2- or 3-year period (lessening the financial impact) or more frequently as new developments occur (such as new or revised policy). Another commenter suggested correcting the cite to “Health Information Patient Privacy Act” to “Health Insurance Portability and Accountability Act of 1996” in § 36.86(a)(4). A commenter suggested changing the title in § 36.86(a)(7) to “Child Abuse Reporting Requirements and Protection Procedures.” Another commenter recommended that in § 36.86(b)(7) we clarify the term “child development” or make the terms applicable only to those residential programs with younger children in residence since some residential programs serve only high school age students. If paragraph
(7)remains in this section, the commenter recommended adding “if appropriate to the student ages served.” *Response:* We considered these comments and made some changes based upon them. We did not change the section title because changes that we made in response to other comments made this unnecessary. Similarly, other changes we made regarding licensure eliminated the need to consider that suggestion. On the issue of training being only a refresher for returning staff, the committee considered this issue in its original deliberations and this comment raised no new issues. *Comment:* A commenter suggested that § 36.86 include a recommendation that courses be provided on dealing with the tween, pre-teen, and teenage adolescent years. *Response:* We considered this comment, but these various developmental stages are covered under the broader title of child development. We revised this section to clarify this. Section 36.90 What Recreation, Academic Tutoring, Student Safety and Health Care Services Must Homeliving Programs Provide? *Comment:* A commenter suggested clarifying in § 36.90 what a “homeliving program board” is and whether it applies to schools with peripheral dorms. *Response:* We accepted the comment and changed § 36.90 to read: “ * * * as deemed necessary by the local school board or homeliving program board.” *Comment:* A commenter suggested that if staff are required to provide these services in § 36.90, it should be required that students be assigned to participate in the service schedule. *Response:* We considered this comment, but it is not something that should be addressed in regulations. *Comment:* A commenter recommended that in § 36.90 we require that library and computer program requirements must be met in the dormitory facility because of the staff-to-student ratio, individual student needs, and academic needs in all subject areas and age/grade levels. *Response:* These issues are addressed in § 36.102. Section 36.91 What Are the Program Requirements for Behavioral Health Services? *Comment:* A commenter suggested that requirements that a reiteration of the Intensive Residential Guidance program elements in § 36.91 is unnecessary because the IRG program was eliminated. Also, costs associated with some of the required services are prohibitive and not all students will require each of the enumerated services. The commenter recommended that this section be revised as follows: “ * * * behavioral health program must include the following services as needed:” *Response:* We considered this comment and clarified the rule to provide that the homeliving program should have the capacity to provide these services. Section 36.92 Are There Any Activities That Must be Offered by a Homeliving Program? *Comment:* A commenter recommended that we clarify § 36.92(a) by providing a requirement for one hour of scheduled, structured physical activity Monday through Thursday instead of through Friday since many residential programs dismiss students on Friday through Sunday. The commenter recommended requiring two hours total of physical or recreational activities for those present in the dorm on the weekend. Another commenter suggested revising § 36.92(b) to allow each tribe/school to decide whether to offer and to decide the content of any of these topics to ensure consistency with local community values. *Response:* We accepted the comment regarding Monday through Thursday physical activity and changed the rule to reflect this. We partially accepted the suggestion regarding personal wellness, excluding the idea of consistency with tribal mores, since it is implicit in the ability to design a wellness program and some schools, such as off-reservation boarding schools, may not have local tribal mores. *Comment:* A commenter recommended changing § 36.92(e) to refer to activities as “personal wellness,” since mandating “character” and “sex education” may not be congruent with the local values or belief systems of the community. *Response:* We accepted the comment and modified § 36.92(e). *Comment:* A commenter recommended deleting the term “structures” in § 36.92 since it is not clear whether a lesson plan is required or students may pick from a choice of activities. *Response:* We considered this comment, but did not modify the rule. The goal of the committee was to have a structured organized physical activity without a program goal or plan. We believe that the term “structure” adequately connotes this. Section 36.93 Is a Homeliving Handbook Required? *Comment:* A commenter suggested that in § 36.93 we add the terms “school board approval.” *Response:* We considered the comment and found the comment unpersuasive. Therefore, we made no change to the regulations. *Comment:* A commenter recommended revising § 36.93 by requiring that the home living handbook be provided rather than referring to student rights and responsibilities and requiring that the handbook be provided during the first week the students are in residence rather than before the first day of school. *Response:* We accepted this comment and revised the section accordingly. *Comment:* A commenter recommended changing “school staff” to “homeliving staff” or “residential staff” in § 36.93(d). *Response:* We considered limiting circulation of the handbook only to homeliving staff. However, we believe that all staff should receive a copy of the handbook. Section 36.94 What Must a Homeliving Handbook Contain? *Comment:* Commenters recommended the following changes to § 36.94: revise
(i)to read “Personnel and position listing or a copy of the residential staff organizational chart”; revise
(l)to “Transportation Policy and Procedures”; revise
(o)to read “Drug, Alcohol and Tobacco Products Policy” and revise
(q)to read: “Medication Administration Policy.” *Response:* We made several of the suggested changes, but did not require an organizational chart or transportation procedures. We do not see the need for requiring an organizational chart. The rule requires transportation policies, not procedures. *Comment:* A commenter suggested that we add drug/alcohol policy and consequences and move up its priority in § 36.94. *Response:* We accepted part of the comment and revised § 36.94(o) to read “drug/alcohol policy.” We rejected the rest of the comment because the list is a list of all items that must be included in the handbook and is not a priority list. Therefore, we did not make the change to the regulations. Section 36.95 What Sanitary Standards Must Homeliving Programs Meet? *Comment:* A commenter recommended changing the term “rooms” to “dorm rooms” for clarification in § 36.95, and adding “unless need arises sooner” at the end of paragraph (c). A commenter recommended that § 36.95(d) and
(e)be revised to read that linens and toiletries “may be provided as needed.” *Response:* We considered this change, but did not revise the rule because the existing is adequate. *Comment:* A commenter recommended that § 36.95 require that dorms pass inspection by some entity, and that each site be visited at least once in five years to verify that health, safety and standards are met. *Response:* We considered this comment and made no change because health and safety inspection requirements vary by locality. Section 36.96 May Students Be Required to Assist With Daily or Weekly Cleaning? *Comment:* A commenter noted that in § 36.96 students should be required to assist in cleaning the dorm. *Response:* We considered the comment, but made no change because that rule already provides for students to assist with cleaning. *Comment:* A commenter suggested we add a provision to § 36.96 for cleaning and maintaining a healthy environment by dorm staff as role models for students. *Response:* We considered the comment and rejected it including any additional provisions on cleaning in § 36.96. Section 36.97 What Basic Requirements Must a Program's Health Services Meet? *Comment:* A commenter recommended revising § 36.97(a) to also allow for agreements between a tribe or tribal school board and IHS. *Response:* We accepted this comment and changed the rule accordingly. Section 36.98 Must the Homeliving Program Have an Isolation Room for Ill Children? *Comment:* A commenter recommended modifying § 36.98 to require that a sickroom be available, but space does not have to be dedicated to this use only. Another commenter recommended rewriting the question in § 36.98 to read: “Must the homeliving program provide special accommodations for ill children?” Using the singular reference to “an isolation room,” coupled with the first sentence and the second sentence could cause confusion as to whether one or two rooms are required. *Response:* We considered these comments and made appropriate changes to the rule. Section 36.100 Are There Minimum Requirements for Student Attendance Checks? *Comment:* A commenter recommended revising § 36.100(d) to state that night time physical checks will be made once every hour, except high school student rooms which will be checked every two hours. *Response:* We considered the comment, but did not change the rule. High school students are just as likely, or even more likely, to be out of their rooms at night. *Comment:* A commenter recommended revising § 36.100(f) to make it applicable only when residential staff knows that a student will be absent from school. *Response:* We accepted this comment and changed the rule accordingly. *Comment:* A commenter suggested that § 36.100 provide that each child accepted into the dorm should agree to undergo drug and alcohol screening if needed. *Response:* We considered the comment and made no change to the rule. Schools should develop their own drug and alcohol policies. Section 36.102 What Student Resources Must be Provided by A Homeliving Program? *Comment:* A commenter recommended that we clarify the terms “library resources” and “reasonable access” in § 36.102. *Response:* We considered the comment, but found no change to the rule necessary. *Comment:* A commenter recommended adding at the beginning of § 36.102(b): “To the extent the student does have their own * * *” *Response:* We considered the comment, but made no change, as the committee believes it is in the best interest of students to have textbooks available after hours. Section 36.110 Must Programs Provide Space for Storing Personal Effects? *Comment:* A commenter recommended adding the following after the first sentence in § 36.110: “This requirement is met if a residential room door can be locked” because some residential facilities will have difficulty meeting the lockable storage space requirement due to space limitations and/or age of the facility. *Response:* We considered this comment, but made no change. The committee wanted the students to have one lockable space, such as a drawer, closet, or storage bin. Section 36.111 Can a Tribe, Tribal Governing Body, or Local School Board Waive the Homeliving Standards? *Comment:* A commenter suggested that in § 36.111 we clarify how 60 days are calculated and recommended that a school board or tribal body submit a proposed waiver by January 1 of the year preceding implementation in order to provide time for revisions and for starting the year with alternative standards in place. *Response:* We considered the comment and rejected it in part because the regulatory section is based on statutory language. We accepted some of the comment and made the following changes: A tribal governing body or local school board may waive some or all of the standards established in this part by adopting a written resolution that determines that the standards are inappropriate for the needs of the tribe's students. The approved alternative standards are effective on the first day of the following school year. Section 36.112 What Are the Consequences for Failing to Meet the Requirements of This Part? *Comment:* A commenter suggested adding a new question after § 36.112: “What happens to a school that does not meet these standards?” *Response:* We considered the comment, but made no changes because this question is limited to whether the school can be closed or consolidated for failing to meet these standards and not for other reasons that are addressed in other regulations. Section 36.120 What Type of Reporting Is Required to Ensure Accountability? *Comment* : A commenter recommended that we identify a specific time for reporting enrolment figures in § 36.120. *Response:* We accepted the comment and revised § 36.120(c) and (d). *Comment:* A commenter recommended adding a requirement in § 36.120 that the report be filed 45 days after the end of the school year and a statement that the accountability report is the only report a residential program is required to file. *Response:* We accepted the suggestions to add a 45-day filing period. *Comment:* A commenter recommended adding a provision in § 36.120 to require that the report also be submitted to the Division of Residential Life in BIE. Response: We did not accept this comment. The BIE already receives the report, and there is no reason to require in the rule that the report go to a particular division within the office. III. Procedural Matters A. Regulatory Planning and Review (E.O. 12866) This document is a significant rule and the Office of Management and Budget
(OMB)has reviewed the rule under Executive Order 12866.
(1)This rule will not have an effect of $100 million or more on the economy. It will not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. The rule deals exclusively with homeliving programs and is not expected to have a significant effect on budgets.
(2)This rule will not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. This rule has been prepared in consultation with the U.S. Department of Education.
(3)This rule does not alter the budgetary effects of entitlements, grants, user fees, or loan programs or the rights or obligations of their recipients. This rule spells out student rights, the procedures for their dissemination, and the procedures for implementing them. The rule is not expected to have a significant effect on budgets.
(4)Office of Management and Budget has determined that this rule raises novel legal or policy issues. For this reason review is required under E.O. 12866. B. Regulatory Flexibility Act The Department of the Interior certifies that this document will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). C. Takings (E.O. 12630) In accordance with Executive Order 12630, the rule does not have significant takings implications. Nothing in the rule proposes rules of private property rights, constitutional or otherwise, or invokes the Federal condemnation power or alters any use of Federal land held in trust. The focus of this rule is homeliving programs. A takings implication assessment is not required. D. Federalism (E.O. 13132) In accordance with Executive Order 13132, the rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. Nothing in this rule has 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. This rule does not implicate State government. A Federalism Assessment is not required. E. Consultation With Indian Tribes (E.O. 13175) In accordance with Executive Order 13175, we have identified potential effects on federally recognized Indian tribes that will result from this rule. Accordingly:
(1)We have consulted with the affected tribe(s) on a government-to-government basis. The consultations have been open and candid to allow the affected tribe(s) to fully evaluate the potential effect of the rule on trust resources.
(2)We have fully considered tribal views in drafting this final rule.
(3)We have consulted with the appropriate bureaus and offices of the Department about the political effects of this rule on Indian tribes. The BIE and the Office of the Assistant Secretary—Indian Affairs have been consulted. F. Paperwork Reduction Act This rulemaking requires information collection from 10 or more parties and a submission under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ) is required. Accordingly, the Department prepared submissions on these collections for review and approval by OMB. Having reviewed the Department's submissions, along with any comments that were submitted by the reviewing public, OMB has approved the information collection requirements in this rulemaking and has assigned the OMB control number 1076-0164. In addition to this number, the information collections in part 39 are also covered by OMB control numbers 1076-0134 and 1076-0122. The information collected will be used to enable the Bureau to better administer Bureau-funded schools subject to this rulemaking. In all instances, the Department has striven to lessen the burden on the public and ask for only information essential to administering the responsibility to federally recognized tribes. The public may make additional comments on the accuracy of our burden estimates (which are explained in detail in the preamble to the proposed rule published on February 25, 2004, at 69 FR 8752) and any suggestions for reducing this burden to the OMB Interior Desk Officer, Docket Number 1076-AE49, Office of Information and Regulatory Affairs, 202/395-6566 (facsimile); email: *OIRA_DOCKET@omb.eop.gov.* G. National Environmental Policy Act This rule does not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the National Environmental Policy Act of 1969 is not required. H. Civil Justice Reform (E.O. 12988) In accordance with Executive Order 12988, the Department 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. List of Subjects in 25 CFR Part 36 Indians—Education, Schools, Elementary and secondary education programs, grant programs—Indians, Government programs—education. Dated: October 19, 2007. Carl J. Artman, Assistant Secretary—Indian Affairs. For the reasons given in the preamble, part 36 of Title 25 of the Code of Federal Regulations is amended by revising subpart G to read as follows: PART 36—MINIMUM ACADEMIC STANDARDS FOR THE BASIC EDUCATION OF INDIAN CHILDREN AND NATIONAL CRITERIA FOR DORMITORY SITUATIONS Subpart G—Homeliving Programs Sec. § 36.70 What terms do I need to know? § 36.71 What is the purpose of this part? Staffing § 36.75 What qualifications must homeliving staff possess? § 36.76 Who is in charge of all homeliving operations? § 36.77 What are the homeliving staffing requirements? § 36.78 What are the staffing requirements for homeliving programs offering less than 5 nights service? § 36.79 What are the homeliving behavioral staff/student ratio requirements? § 36.80 If a school has separated boys' and girls' homeliving programs, may the same behavioral staff be used for each program? § 36.81 May a homeliving program use support staff or teachers to meet behavioral health staffing requirements? § 36.82 May behavioral health staff provide services during the academic school day? § 36.83 How many hours can a student be taken out of the academic setting to receive behavioral health services? § 36.84 Can a program hire or contract or acquire by other means behavioral health professionals to meet staffing requirements? § 36.85 Is a nurse required to be available in the evenings? § 36.86 Are there staff training requirements? Program Requirements § 36.90 What recreation, academic tutoring, student safety and health care services must homeliving programs provide? § 36.91 What are the program requirements for behavioral health services? § 36.92 Are there any activities that must be offered by a homeliving program? § 36.93 Is a homeliving handbook required? § 36.94 What must a homeliving handbook contain? § 36.95 What sanitary standards must homeliving programs meet? § 36.96 May students be required to assist with daily or weekly cleaning? § 36.97 What basic requirements must a program's health services meet? § 36.98 Must the homeliving program have an isolation room for ill children? § 36.99 Are immunizations required for residential program students? § 36.100 Are there minimum requirements for student attendance checks? § 36.101 How often must students who have been separated for emergency health or behavioral reasons be supervised? § 36.102 What student resources must be provided by a homeliving program? § 36.103 Are there requirements for multipurpose spaces in homeliving programs? Privacy § 36.110 Must programs provide space for storing personal effects? Waivers and Accountability § 36.111 Can a tribe, tribal governing body or local school board waive the homeliving standards? § 36.112 Can a homeliving program be closed, transferred, consolidated, or substantially curtailed for failure to meet these standards? § 36.120 What type of reporting is required to ensure accountability? Subpart G—Homeliving Programs Authority: 25 U.S.C. 13; 25 U.S.C. 2008; Pub. L. 107-110 (115 Stat. 1425). § 36.70 What terms do I need to know? The following definitions apply to this subpart: *Behavioral health professional* means a State licensed or State certified Social Worker, School Counselor, Drug and Alcohol Counselor, School Psychologist, or School Psychometrist responsible for coordinating a broad range of needs including:
(1)Support groups;
(2)Individual counseling;
(3)Crisis intervention;
(4)Preventive activities; and
(5)Coordination of referrals and outside services with appropriate providers. *Behavioral Health Program* means a homeliving based service designed to decrease barriers to learning or increase positive, personal well-being by:
(1)Providing early intervention services, coordinating crisis intervention and prevention services;
(2)Promoting a positive social and emotional environment;
(3)Reducing the incidence of problems; and
(4)Referring students with behavioral needs that require professional medical care to an appropriate residential care facility. *Behavioral health services* means the services provided by a school behavioral health program as defined in this section. *Homeliving Manager* means the employee responsible for direct supervision of the homeliving program staff and students. *Homeliving Program* means a program that provides room and board in a boarding school or dormitory to residents who are either:
(1)Enrolled in and are current members of a public school in the community in which they reside; or
(2)Members of the instructional program in the same boarding school in which they are counted as residents and:
(i)Are officially enrolled in the residential program of a Bureau-operated or funded school; and
(ii)Are actually receiving a homeliving program provided to all students who are provided room and board in a boarding school or dormitory. *Homeliving Program Staff* means the employee(s) responsible for direct supervision of students in the homeliving area. *Homeliving Supervisor* means the employee with overall administrative responsibility for supervising students, programs, and personnel in the homeliving area. § 36.71 What is the purpose of this part? The purpose of this part is to establish standards for homeliving programs. Staffing § 36.75 What qualifications must homeliving staff possess?
(a)Homeliving staff must possess the qualifications shown in the following table: Position Required training
(1)Homeliving Supervisor Must be qualified based on size and complexity of the school, but at minimum possess a bachelor's degree.
(2)Homeliving Manager Must be qualified based on the size and complexity of the student body but must at a minimum have an associate's degree no later than 2008.
(3)Homeliving Program Staff Must have at least 32 post-secondary semester hours (or 48 quarter hours) in an applicable academic discipline, including fields related to working with children, such as, child development, education, behavioral sciences and cultural studies.
(b)A person employed as a homeliving program staff:
(1)Should meet the requirements of paragraph
(a)of this section by the 2009-2010 school year; and
(2)May, upon showing good cause, petition the school supervisor (or the homeliving supervisor for peripheral dorms) for a waiver from the new qualifications. § 36.76 Who is in charge of all homeliving operations? One staff member who has the authority to ensure the successful functioning of all phases of the homeliving program should be designated as in charge of all homeliving operations. All staff should be advised of the lines of authority through an organizational chart approved by the local board responsible for operations of the homeliving program. § 36.77 What are the homeliving staffing requirements? Homeliving programs must meet the staffing requirements of this section.
(a)Effective with the 2009-2010 school year, each homeliving program must maintain the following student minimum supervisory requirements on weekdays: Grade level Time of day Ratio Elementary (Grade 1-6) Morning 1:20. During school As school needs. Evening 1:20. Night 1:40. High School (Gr. 7-12) Morning 1:20. During school As school needs. Evening 1:30. Night 1:50.
(b)The following staffing ratios apply on weekends: Grade level Time of day Ratio Elementary (Grade 1-6) Morning/day 1:20. Evening 1:20. Night 1:40. High School (Gr. 7-12) Morning/day 1:40. Evening 1:40. Night 1:50. § 36.78 What are the staffing requirements for homeliving programs offering less than 5 nights service? For homeliving programs providing less than 5 nights service, the staffing levels from § 36.77 apply. To fill this requirement, the program must use only employees who work a minimum of 20 hours per week. § 36.79 What are the homeliving behavioral professional staff/student ratio requirements? Behavioral health professional(s) is necessary in homeliving programs to address issues, such as abuse, neglect, trauma, cultural conflict, and lack of school success. Each homeliving program must provide a minimum of one half-time behavioral health professional for every 50 students.
(a)The program may fill the staffing requirements of this section by using contract services, other agencies (including the Indian Health Service) or private/nonprofit volunteer service organizations.
(b)Off-reservation homeliving programs should consider providing one full-time behavioral health professional for every 50 students.
(c)For purposes of this section, a one half-time behavioral health professional is one that works for the homeliving program a minimum of 20 hours per week.
(d)For purposes of this section, in instances where the behavioral health services are obtained through other programs, the behavioral health professional must be available at the request of the homeliving program. § 36.80 If a school or dormitory has separated boys' and girls' homeliving programs, may the same behavioral professional be used for each program? Yes, a program may use the same behavioral professional for both boys' and girls' programs. However, behavioral health staffing requirements are based on the combined enrollment during the homeliving count period. § 36.81 May a homeliving program use support staff or teachers to meet behavioral health staffing requirements? No, a homeliving program must not use support staff or teachers to meet behavioral health staffing requirements. The only exception is if the individual support staff employee or teacher has the appropriate behavioral health license or certification. § 36.82 May behavioral health professional(s) provide services during the academic school day? Behavioral health professional(s) must average at least 75 percent of their work hours with students in their dormitories. These work hours must occur outside of the academic school day, except in emergency situations as deemed by the administrative head of the homeliving program or designee. The purpose of this requirement is to maximize contact time with students in their homeliving setting. § 36.83 How many hours can a student be taken out of the academic setting to receive behavioral health services? A student may spend no more than 5 hours per week out of the academic setting to receive behavioral health services from the homeliving behavioral health professional(s), except for emergency situations. § 36.84 Can a program hire or contract or acquire by other means behavioral health professionals to meet staffing requirements? A program may hire or contract behavioral health professionals to meet staffing requirements or acquire such services by other means such as through a Memorandum of Understanding with other programs.
(a)At least one individual must be a licensed or certified school counselor or a social worker who is licensed/certified to practice at the location where the services are provided.
(b)For additional staffing, other individuals with appropriate certifications or licenses are acceptable to meet staffing requirements. § 36.85 Is a nurse required to be available in the evenings? No, a program is not required to make a nurse (LPN or RN) available in the evenings. However, this is encouraged for homeliving programs with an enrollment greater than 300 or for programs that are more than 50 miles from available services. § 36.86 Are there staff training requirements?
(a)All homeliving program staff as well as all employees that supervise students participating in homeliving services and activities must have the appropriate certification or licensing requirements up to date and on file. Programs must provide annual and continuous professional training and development appropriate to the certification and licensing requirements.
(b)All homeliving program staff as well as all employees who supervise students participating in homeliving services and activities must receive annual training in the topics set out in this section before the first day of student occupancy for the year.
(1)First Aid/Safety/Emergency & Crisis Preparedness;
(2)CPR—Automated External Defibrillator;
(3)Student Checkout Policy;
(4)Confidentiality (Health Information Privacy Act and the Family Education Right to Privacy Act.);
(5)Medication Administration;
(6)Student Rights;
(7)Child Abuse Reporting Requirements and Protection Procedures; and
(8)Suicide Prevention.
(c)Homeliving staff as well as all employees that supervise students participating in homeliving services and activities must be given the following training annually:
(1)De-escalation/Conflict Resolution;
(2)Substance Abuse Issues;
(3)Ethics;
(4)Parenting skills/Child Care;
(5)Special Education and Working with Students with Disabilities;
(6)Student Supervision Skills;
(7)Child Development (recognizes various stages of development in the student population);
(8)Basic Counseling Skills; and
(9)Continuity of Operations Plan (COOP). Program Requirements § 36.90 What recreation, academic tutoring, student safety, and health care services must homeliving programs provide? All homeliving programs must provide for appropriate student safety, academic tutoring, recreation, and health care services for their students, as deemed necessary by the local school board or homeliving board. § 36.91 What are the program requirements for behavioral health services?
(a)The homeliving behavioral health program must make available the following services:
(1)Behavioral Health Screening/Assessment;
(2)Diagnosis;
(3)Treatment Plan;
(4)Treatment and Placement;
(5)Evaluation; and
(6)Record of Services (if applicable, in coordination with the student's Individual Education Plan).
(b)Each homeliving behavioral health program must have written procedures for dealing with emergency behavioral health care issues.
(c)Parents or guardians may opt out of any non-emergency behavioral health services by submitting a written request.
(d)Parents or guardians must be consulted before a child is prescribed behavioral health.
(e)Medication in a non-emergency situation. § 36.92 Are there any activities that must be offered by a homeliving program? Yes, a homeliving program must make available the following activities:
(a)One hour per day of scheduled, structured physical activity Monday through Thursday, and two hours of scheduled physical activities on the weekends for any students who are in residence on the weekends;
(b)One hour per day of scheduled, structured study at least four days per week for all students, and additional study time for students who are failing any classes;
(c)Tutoring during study time;
(d)Native language or cultural activities; and
(e)Wellness program that may include character, health, wellness, and sex education. § 36.93 Is a homeliving handbook required? Yes, each program must publish a homeliving handbook, which may be incorporated into a general student handbook. During the first week the students and staff are in the dormitory, the homeliving program must:
(a)Provide each student with a copy of the handbook that contains all the provisions in § 36.94;
(b)Provide all staff, students, and parents or guardians with a current and updated copy of student rights and responsibilities;
(c)Conduct an orientation for all students on the handbook and student rights and responsibilities; and
(d)Ensure that all students, school staff, and to the extent possible, parents and guardians confirm in writing that they have received a copy of and understand the homeliving handbook. § 36.94 What must a homeliving handbook contain? A homeliving handbook must contain all of the following, and may include additional information:
(a)Mission/Vision Statement;
(b)Discipline Policy;
(c)Parent/Student Rights and Responsibilities;
(d)Confidentiality;
(e)Sexual Harassment Policy;
(f)Violence/Bullying Policy;
(g)Homeliving Policies and Procedures;
(h)Services Available;
(i)Personnel and Position Listing;
(j)Emergency Procedures and Contact Numbers;
(k)Bank Procedures;
(l)Transportation Policy;
(m)Check-Out Procedures;
(n)Dress Code;
(o)Drug/Alcohol Policy;
(p)Computer Usage Policy;
(q)Medication Administration Policy and Procedure; and
(r)Isolation/Separation Policy. § 36.95 What sanitary standards must homeliving programs meet? Each homeliving program must meet all of the following standards:
(a)Restrooms, showers, and common areas must be cleaned daily;
(b)Rooms must be cleaned daily;
(c)Linens must be changed and cleaned weekly;
(d)Linens are to be provided;
(e)Basic Toiletries must be provided; and
(f)Functional washing machines and dryers must be provided. § 36.96 May students be required to assist with daily or weekly cleaning? Yes, students can be required to assist with daily or weekly cleaning. However, the ultimate responsibility of cleanliness rests with the homeliving supervisor and local law or rules regarding chemical use must be followed. § 36.97 What basic requirements must a program's health services meet?
(a)A homeliving program must make available basic medical, dental, vision, and other necessary health services for all students residing in the homeliving program, subject to agreements between the BIE and the Indian Health Service or between a tribally-operated homeliving program and the Indian Health Service or tribal health program.
(b)A homeliving program must have written procedures for dealing with emergency health care issues.
(c)Parents or guardians may opt out of any non-emergency services by submitting a written request.
(d)The homeliving supervisor or designee must act *in loco parentis* when the parent or guardian cannot be found. § 36.98 Must the homeliving program have an isolation room for ill children? Yes, the homeliving program must have an isolation room(s) available for ill students. The isolation room (or rooms, if needed) must be made available for use by students with contagious conditions. Contagious boys and girls should have separate rooms. The isolation room(s) should have a separate access to shower and restroom facilities. Students isolated for contagious illness must be supervised as frequently and as closely as the circumstances and protocols require, but at least every 30 minutes. § 36.99 Are immunizations required for residential program students? Each student must have all immunizations required by State, local, or tribal governments before being admitted to a homeliving program. Annual flu shots are not required, but are encouraged. § 36.100 Are there minimum requirements for student attendance checks? Yes, there are minimum requirements for student attendance checks as follows:
(a)All students must be physically accounted for four times daily;
(b)Each count must be at least two hours apart;
(c)If students are on an off-campus activity, physical accounts of students must be made at least once every two hours or at other reasonable times depending on the activity;
(d)At night all student rooms should be physically checked at least once every hour;
(e)If a student is unaccounted for, the homeliving program must follow its established search procedures; and
(f)When homeliving staff is aware of a student who is going to be absent from school, the homeliving program is required to notify the school. § 36.101 How often must students who have been separated for emergency health or behavioral reasons be supervised? Students who have been separated for emergency behavioral or health reasons must be supervised as frequently and as closely as the circumstances and protocols require. No student will be left unsupervised for any period until such factors as the student's health based on a medical assessment, the safety of the student, and any other applicable guidance for dealing with behavior or health emergencies are considered. § 36.102 What student resources must be provided by a homeliving program? The following minimum resources must be available at all homeliving programs:
(a)Library resources such as access to books and resource materials, including school libraries and public libraries which are conveniently available;
(b)A copy of each textbook used by the academic program or the equivalent for peripheral dorms; and
(c)Reasonable access to a computer with Internet access to facilitate homework and study. § 36.103 What are the requirements for multi-purpose spaces in homeliving programs? Homeliving programs must provide adequate areas for sleeping, study, recreation, and related activities. Privacy § 36.110 Must programs provide space for storing personal effects? Yes, students are entitled to private personal spaces for storing their own personal effects, including at least one lockable closet, dresser drawer, or storage space. However, all drawers, dressers, storage space, or lockable space are the property of the homeliving program and are subject to random search. Waivers and Accountability § 36.111 Can a tribe, tribal governing body, or local school board waive the homeliving standards? A tribal governing body or local school board may waive some or all of the standards established by this part if the body or board determines that the standards are inappropriate for the needs of the tribe's students.
(a)If a tribal governing body or school board waives standards under this section, it must, within 60 days, submit proposed alternative standards to the Director, BIE.
(b)Within 90 days of receiving a waiver and proposal under paragraph
(a)of this section, the Director must either:
(1)Approve the submission; or
(2)Deliver to the governing body or school board a written explanation of the good cause for rejecting the submission.
(c)If the Director rejects a submission under paragraph
(c)of this section, the governing body or school board may submit another waiver and proposal for approval. The standards in this part remain in effect until the Director approves alternative standards. § 36.112 Can a homeliving program be closed, transferred, consolidated, or substantially curtailed for failure to meet these standards? No, a homeliving program cannot be closed, transferred to any other authority, consolidated, or its programs substantially curtailed for failure to meet these standards. § 36.120 What type of reporting is required to ensure accountability? The homeliving program must provide to the appropriate local school board or alternative board such as a homeliving board, the tribal governing body, BIE, and the Secretary of the Interior, an annual accountability report within 45 days following the end of the school year consisting of:
(a)Enrollment figures identified by the homeliving count period;
(b)A brief description of programs offered;
(c)A statement of compliance with the requirements of this part and, if the program is not in compliance, recommendations for achieving compliance; and
(d)Recommendations to improve the homeliving program including identification of issues and needs. [FR Doc. E7-23330 Filed 12-4-07; 8:45 am] BILLING CODE 4310-6W-P NATIONAL LABOR RELATIONS BOARD 29 CFR Part 102 Revisions of Regulations Concerning Procedures for Filing Appeals to Denial in Whole or Part of Initial FOIA Requests AGENCY: National Labor Relations Board (NLRB). ACTION: Final Rule. SUMMARY: The National Labor Relations Board
(NLRB)is amending regulations concerning the procedures for filing an appeal to adverse FOIA determinations. The revisions require that appeals be filed within 28 calendar days of the service of the notification of the adverse determination. EFFECTIVE DATE: December 5, 2007. FOR FURTHER INFORMATION CONTACT: Lester A. Heltzer, Executive Secretary, National Labor Relations Board, Room 11600, 1099 14th Street NW., Washington, DC 20570-0001, Telephone
(202)273-1067, e-mail address *Lester.Heltzer@nlrb.gov.* SUPPLEMENTARY INFORMATION: I. Current regulation Section 102.117(c)(2)(v) provides in part that “An appeal from an adverse determination made pursuant to paragraph (c)(2)(iii) of this section must be filed within 20 working days of the receipt by the person making the request of the notification of the adverse determination where the request is denied in its entirety; or, in the case of a partial denial, within 20 working days of the receipt of any records being made available pursuant to the request.” II. Proposed revision Since the Agency does not send such determinations on initial requests by certified mail, it has no objective means of determining when a requestor receives an adverse determination. Therefore, it is impossible to know from which date to compute time periods from adverse FOIA determinations. Other agencies' practices support using the date of service rather than date of receipt as the appropriate date for computing timeliness of FOIA appeals. Under 28 CFR Ch. 1, Sec. 16.9, appeals from adverse Department of Justice FOIA determinations must be filed “within 60 days of the date of the letter denying” the request. See also, *Center for Biological Diversity v. Gutierrez,* 451 F. Supp.2d 57 (D.D.C. 2006)(Department of Commerce regulations provide that appeals from adverse determinations must be received by 5 p.m. EST on the “thirtieth day after issuance of initial FOIA determination * * *” 15 CFR Sec. 410(a)); *Wilbur* v. *Central Intelligence Agency,* 355 F.3rd 675 (DC. Cir. 2004) (The CIA's FOIA regulations require that any administrative appeal “be received within 45 days of the agency's initial decision.” 32 CFR Sec. 1900.42.) III. Administrative Procedures Act Because the change involves rules of agency organization, procedure or practice, the Agency is not required to publish it for comment under Section 553 of the Administrative Procedure Act (5 U.S.C. 553). IV. Regulatory Flexibility Act Because no notice of proposed rulemaking is required for procedural rules, the requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) pertaining to regulatory flexibility analysis do not apply to these rules. However, even if the Regulatory Flexibility Act were to apply, the NLRB certifies that these changes will not have a significant economic impact on small business entities since the changes merely codify the actual practice under the existing rules. V. Small Business Regulatory Enforcement Fairness Act Because the rule relates to Agency procedure and practice and merely modifies the agency's existing filing procedures, the Board has determined that the Congressional review provisions of the Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801) do not apply. VI. Paperwork Reduction Act This revision does not impose any reporting or record keeping requirements under the Paperwork Reduction Act of 1995. Lists of Subjects in 29 CFR Part 102 Administrative practice and procedure, Labor Management relations. For the reasons set forth above, the NLRB proposes to amend 29 CFR part 102 as follows: PART 102—RULES AND REGULATIONS 1. The authority citation for 29 CFR part 102 continues to read as follows: Authority: Section 6, National Labor Relations Act, as amended ((29 U.S.C. 151, 156). Section 102.117(c) also issued under Section 552(a)(4)(A) of the Freedom of Information Act, as amended (5 U.S.C. 552(a)(4)(A)). Sections 102.143 through 102.155 also issued under Section 504(c)(1) of the Equal Access to Justice Act, as amended (5 U.S.C. 504(c)(1)). 2. Section 102.117(c)(2)(v) is revised to read as follows: § 102.117 Freedom of Information Act Regulations: Board materials and formal documents available for public inspection and copying; requests for described records; time limit for response; appeal from denial of request; fees for document search and duplication; files and records not subject to inspection.
(c)* * *
(2)* * *
(v)An appeal from an adverse determination made pursuant to paragraph (c)(2)(iii) of this section must be filed within 28 calendar days of the service of the notification of the adverse determination, in whole or in part. If the adverse determination was made in a Regional Office, a Subregional Office, or by the Freedom of Information Officer, Office of the General Counsel, the appeal shall be filed with the General Counsel in Washington, DC. If the adverse determination was made by the Executive Secretary of the Board or the Inspector General, the appeal shall be filed with the Chairman of the Board in Washington, DC. Within 20 working days after receipt of an appeal the General Counsel or the Chairman of the Board, as the case may be, shall make a determination with respect to such appeal and shall notify the person making the request in writing. If the determination is to comply with the request, the record shall be made promptly available to the person making the request upon receipt of payment of any charges due in accordance with the provisions of paragraph (d)(2) of this section. If on appeal the denial of the request for records is upheld in whole or in part, the person making the request shall be notified of the reasons for the determination, the name and title or position of each person responsible for the denial, and the provisions for judicial review of that determination under the provisions of 5 U.S.C. 552(4)(B). Even though no appeal is filed from a denial in whole or in part of a request for records by the person making the request, the General Counsel or the Chairman of the Board may, without regard to the time limit for filing of an appeal, sua sponte initiate consideration of an adverse determination under this appeal procedure by written notification to the person making the request. In such event the time limit for making the determination shall commence with the issuance of such notification. An adverse determination by the General Counsel or the Chairman of the Board, as the case may be, will be the final action of the Agency. If the requester wishes to seek review by a court of any adverse determination, the requester must first appeal it under this section. Dated: Washington, DC, November 29, 2007. By Direction of the Board. Lester A. Heltzer, Executive Secretary. [FR Doc. E7-23521 Filed 12-4-07; 8:45 am] BILLING CODE 7545-01-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [CGD01-07-158] Drawbridge Operation Regulations; Cheesequake Creek, Morgan, NJ AGENCY: Coast Guard, DHS. ACTION: Notice of temporary deviation from regulations. SUMMARY: The Commander, First Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the New Jersey Transit Rail Operation (NJTRO) Railroad Bridge across Cheesequake Creek, mile 0.2, at Morgan, New Jersey. Under this temporary deviation, the bridge may remain in the closed position from January 2, 2008 through March 31, 2008. Vessels that can pass under the draw without a bridge opening may do so at all times. This deviation is necessary to facilitate scheduled bridge maintenance. DATES: This deviation is effective from January 2, 2008 through March 31, 2008. ADDRESSES: Materials referred to in this document are available for inspection or copying at the First Coast Guard District, Bridge Branch Office, One South Street, New York, New York 10004, between 7 a.m. and 3 p.m., Monday through Friday, except Federal holidays. The telephone number is
(212)668-7165. The First Coast Guard District Bridge Branch Office maintains the public docket for this temporary deviation. FOR FURTHER INFORMATION CONTACT: Joe Arca, Project Officer, First Coast Guard District, at
(212)668-7069. SUPPLEMENTARY INFORMATION: The NJTRO railroad bridge has a vertical clearance of 3 feet at mean high water, and 8 feet at mean low water in the closed position. The existing drawbridge operating regulations, listed at 33 CFR 117.709(b), require the bridge to open on signal; except that, at least a four hour notice for bridge openings is required from January 1 through March 31 from 6 p.m. to 6 a.m. The bridge owner, New Jersey Transit Rail Operations (NJTRO), requested a bridge closure to facilitate structural and mechanical rehabilitation at the NJTRO railroad bridge. Under this temporary deviation, the NJTRO railroad bridge may remain closed to navigation from January 1, 2008 through March 31, 2008. Vessels that can pass under the bridge without an opening may do so at all times. A small number of fishing boats are docked upstream from the NJTRO railroad bridge; however, Cheesequake Creek is predominantly a recreational waterway. From January through March, the recreational vessels are in winter storage and the waterway is normally not transited. The Coast Guard met with the mariners to discuss this bridge project and related closure. The mariners agreed with the closure dates since that is the time period the bridge seldom opens and the waterway is normally frozen. In accordance with 33 CFR 117.35(e), the bridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35. Should the bridge maintenance authorized by this temporary deviation be completed before the end of the effective period published in this notice, the Coast Guard will rescind the remainder of this temporary deviation, and the bridge shall be returned to its normal operating schedule. Notice of the above action shall be provided to the public in the Local Notice to Mariners and the **Federal Register** , where practicable. Dated: November 26, 2007. Gary Kassof, Bridge Program Manager, First Coast Guard District. [FR Doc. E7-23568 Filed 12-4-07; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. CGD01-07-150] RIN 1625-AA00 Safety Zone: Wantagh Parkway 3 Bridge over the Sloop Channel, Town of Hempstead, New York AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is extending the effective period of a temporary safety zone previously established on the waters surrounding the Wantagh Parkway Number 3 Bridge across the Sloop Channel in Town of Hempstead, New York. The extended effective period of this zone is necessary to protect vessels transiting in the area from hazards imposed by construction barges and equipment that are being utilized to construct a new bascule bridge over the Sloop Channel. Entry into this zone is prohibited unless authorized by the Captain of the Port Long Island Sound, New Haven, Connecticut. DATES: This rule is effective from January 4, 2008 until 11:59 p.m. June 30, 2008. ADDRESSES: Documents indicated in this preamble as being available in the docket are part of docket CGD01-07-150 and will be available for inspection or copying at Sector Long Island Sound, New Haven, CT, between 9 a.m. and 3 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Lieutenant D. Miller, Assistant Chief, Waterways Management Division, Coast Guard Sector Long Island Sound at
(203)468-4596. SUPPLEMENTARY INFORMATION: Regulatory History We did not publish notice of proposed rulemaking
(NPRM)for this regulation. Under 5 U.S.C. 553 (b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Any delay encountered in this regulation's effective date would be impracticable and contrary to public interest since immediate action to restrict and control maritime traffic transiting in the vicinity of the Sloop Channel under the Wantagh Parkway Number 3 Bridge in the Town of Hempstead, Nassau County, Long Island, New York is needed to ensure the safety of vessels transiting the area. In 2003, the Coast Guard approved bridge construction and issued a permit for bridge construction for the Wantagh Parkway Number 3 Bridge over the Sloop Channel. Contractors began work constructing the two bascule piers for the new bridge in early June 2004. A safety zone was not deemed necessary at the inception of the construction, as this channel is primarily used by smaller recreational vessels, which could maneuver outside of the channel. However, bridge construction equipment that remains under the Wantagh Parkway Number 3 Bridge poses a potential hazard greater than originally anticipated. A safety zone was deemed necessary and was established on October 9, 2004 through December 31, 2004, the date when construction impacting the navigable channel was estimated to be complete. A second safety zone was implemented on January 1, 2005 and extended until December 31, 2005 due to delays in construction, requiring equipment to be in the channel in a manner that would leave the waterway unsafe to marine traffic. Due to continued significant delays in bridge construction, the safety zone was extended until December 31, 2006. Construction delays continued and the safety zone extended again to December 31, 2007. The contractor for this project continues to experience significant delays in bridge construction. In order to continue construction in a more rapid and safe manner, barges will need to continuously block the channel under the bridge. Accordingly, the New York State Department of Transportation (NYSDOT) has requested that a safety zone be put in place through June 30, 2008. At that time, the construction progress will allow the contractors to remove the equipment from the channel. As the construction equipment is presently obstructing the navigable channel, immediate action is needed to prevent accidents by limiting vessel movement in the area with the construction equipment. Traffic exists in this area year round and increases significantly in the summer months with the return of recreational traffic. Background and Purpose Currently, there is a fixed bridge over the Wantagh Parkway Number 3 Bridge over the Sloop Channel in the Town of Hempstead, New York. New York Department of Transportation determined that a moveable bridge would benefit the boating community. In 2003, the Coast Guard approved bridge construction and issued a permit for bridge construction for the Wantagh Parkway Number 3 Bridge over the Sloop Channel. Contractors began work constructing the two-bascule piers for the new bridge in early June 2004. The equipment necessary for the construction of the bridge occupies the entire navigable channel. While there are side channels, which can be navigated, the equipment in the channel is extensive and poses a hazard to recreational vessels attempting to transit the waterway via the side channels under the bridge. Construction, requiring equipment in the navigable channel, was originally scheduled to end on December 31, 2004. Numerous delays in the construction have required construction equipment to continue to occupy the navigable channel and have required three subsequent extensions of the established safety zone through December 31, 2005 and then through December 31, 2006 and most recently through December 31, 2007 when the contractor continued to experience significant delays. Due to continued construction delays, the NYSDOT has requested that a safety zone be in place through June 30, 2008. To ensure the continued safety of the boating community, the Coast Guard is extending the effective period of the safety zone that is currently in place in all waters of the Sloop Channel within 300-yards of the Wantagh Parkway Number 3 Bridge. This safety zone is necessary to protect the safety of the boating community who wish to utilize the Sloop Channel. Vessels may utilize the Goose Neck Channel as an alternative route to using the Sloop Channel, adding minimal additional transit time. Marine traffic may also transit safely outside of the safety zone during the effective dates of the safety zone, allowing navigation in the Sloop Channel, except the portion delineated by this rule. Discussion of Rule This regulation extends the effective period of a temporary safety zone on the waters of the Sloop Channel within 300-yards of the Wantagh Parkway Bridge. This action is intended to prohibit vessel traffic in a portion of the Sloop Channel in the Town of Hempstead, New York to provide for the safety of the boating community due to the hazards posed by significant construction equipment and barges located in the waterway for the construction of a new bascule bridge. The effective period of this safety zone is continued to 11:59 p.m. on June 30, 2008. Marine traffic may continue to transit safely outside of the safety zone during the effective dates of the safety zone, allowing navigation in the Sloop Channel, except the portion delineated by this rule. Entry into this zone is prohibited unless authorized by the Captain of the Port, Long Island Sound. Any violation of the safety zone described herein is punishable by, among other things, civil and criminal penalties, in rem liability against the offending vessel, and the initiation of suspension or revocation proceedings against Coast Guard-issued merchant mariner credentials. Regulatory Evaluation This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. This regulation may have some impact on the public, but the potential impact will be minimized for the following reasons: vessels may transit in all areas of the Sloop Channel other than the area of the safety zone, and may utilize other routes with minimal increased transit time. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule will have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in those portions of the Sloop Channel in the Town of Hempstead, New York covered by the safety zone. For the reasons outlined in the Regulatory Evaluation section above, this rule will not have a significant impact on a substantial number of small entities. Assistance for Small Entities Under subsection 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 [Pub. L. 104-121], the Coast Guard wants to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking. If this rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call Lieutenant D. Miller Chief, Waterways Management Division, Coast Guard Sector Safety Office Long Island Sound at
(203)468-4596. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action fo the Coast Guard. Collection of Information This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. Civil Justice Reform This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Protection of Children We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and will not concern an environmental risk to health or risk to safety that may disproportionately affect children. Indian Tribal Governments This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, 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. Energy Effects We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore it does not require a Statement of Energy Effects under Executive Order 13211. Technical Standards The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment The Coast Guard analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969
(NEPA)42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation. This rule fits the category selected from paragraph (34)(g), as it establishes a safety zone. An final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES . List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows: PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority: 33 U.S.C. 1225 and 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. Amend § 165.T01-132 by revising paragraph
(b)to read as follows: § 165.T01-132 Safety Zone: Wantagh Parkway Number 3 Bridge over the Sloop Channel, Town of Hempstead, NY.
(b)*Effective date:* This rule is effective from 11:59 p.m. on January 22, 2007 until 11:59 p.m. June 30, 2008. Dated: November 20, 2007. D.A. Ronan, Captain, U.S. Coast Guard, Captain of the Port, Long Island Sound. [FR Doc. E7-23569 Filed 12-4-07; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [CGD09-07-127] RIN 1625-AA11 Safety Zone, Chicago Harbor, Navy Pier East, Chicago, IL AGENCY: Coast Guard, DHS. ACTION: Notice of enforcement of regulation. SUMMARY: The Coast Guard will enforce the Navy Pier East Safety Zone in Chicago Harbor on December 4, 2007. This action is necessary to protect vessels and people from the hazards associated with fireworks displays. This safety zone will restrict vessel traffic from a portion of the Captain of the Port Lake Michigan Zone. DATES: Effective from 8:30 p.m. to 10 p.m. on December 4, 2007. FOR FURTHER INFORMATION CONTACT: CWO Brad Hinken, Prevention Department, Coast Guard Sector Lake Michigan, Milwaukee, WI at
(414)747-7154. SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the Safety Zone, Navy Pier East, Chicago Harbor, Chicago, IL, 33 CFR 165.933 for the following event:
(1)*Total Event Resources* on December 4, 2007 from 8:30 p.m. through 10 p.m. All vessels must obtain permission from the Captain of the Port or his designated representative to enter, move within, or exit the safety zone. Vessels and persons granted permission to enter the safety zone shall obey all lawful orders or directions of the Captain of the Port or a designated representative. While within a safety zone, all vessels shall operate at the minimum speed necessary to maintain a safe course. This notice is issued under authority of 33 CFR 165.933 Safety Zone, Navy Pier East, Chicago Harbor, Chicago, IL (72 FR 32525 (June 13, 2007)) and 5 U.S.C. 552(a). In addition to this notice in the **Federal Register** , the Coast Guard will provide the maritime community with advance notification of these enforcement periods via broadcast Notice to Mariners and Local Notice to Mariners. The Captain of the Port will issue a Broadcast Notice to Mariners notifying the public when enforcement of the safety zone established by this section is suspended. The Captain of the Port may be contacted via U.S. Coast Guard Sector Detroit on channel 16, VHF-FM. Dated: November 20, 2007. Sean R. Murtagh, Commander, U.S. Coast Guard, Acting Captain of the Port Lake Michigan. [FR Doc. E7-23570 Filed 12-4-07; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 3 RIN 2900-AM47 Extension of the Presumptive Period for Compensation for Gulf War Veterans AGENCY: Department of Veterans Affairs. ACTION: Final rule. SUMMARY: This document affirms an amendment to the Department of Veterans Affairs
(VA)adjudication regulation regarding compensation for disabilities resulting from undiagnosed illnesses suffered by veterans who served in the Persian Gulf War. This amendment is necessary to extend the presumptive period for qualifying chronic disabilities resulting from undiagnosed illnesses that must become manifest to a compensable degree in order that entitlement for compensation be established. The intended effect of this amendment is to provide consistency in VA adjudication policy and preserve certain rights afforded to Persian Gulf War veterans and ensure fairness for current and future Persian Gulf War veterans. DATES: *Effective Date:* December 5, 2007. FOR FURTHER INFORMATION CONTACT: Rhonda F. Ford, Chief, Regulations Staff (211D), Compensation and Pension Service, Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420,
(202)273-7210. (This is not a toll-free number). SUPPLEMENTARY INFORMATION: In response to the needs and concerns of veterans of the Persian Gulf War (Gulf War), Congress enacted the Persian Gulf War Veterans' Benefits Act, title I of the Veterans' Benefits Improvements Act of 1994, Public Law 103-446, which was codified in relevant part at 38 U.S.C. 1117. This law provided authority to the Secretary of Veterans Affairs (Secretary) to compensate Gulf War veterans with a chronic disability resulting from an undiagnosed illness that became manifest either during service on active duty in the Southwest Asia theater of operations during the Persian Gulf War or to a degree of 10 percent or more during a presumptive period determined by the Secretary. Section 1117 directs the Secretary to prescribe by regulation the presumptive period following service in the Southwest Asia theater of operations determined to be appropriate for the manifestation of an illness warranting payment of compensation. On December 18, 2006, we published an interim final rule extending the presumptive period in 38 CFR 3.317 to December 31, 2011 (71 FR 75669). We provided a 60-day comment period that ended February 16, 2007. We received one comment from a concerned individual and one comment from The American Legion. The individual commented that it was important to acknowledge an undiagnosed illness as a real medical condition. We will make no change based on this comment. We note that both statute and regulation authorize payment of compensation for specific disabilities resulting from undiagnosed illnesses, thus recognizing the existence of undiagnosed illnesses for purposes of VA benefits. Moreover, we believe that the extension of the presumptive period and other existing regulations regarding disabilities and illnesses related to the Gulf War will continue to ensure that veterans with compensable disabilities due to undiagnosed illnesses that may be related to active service in the Southwest Asia theater of operations during the Persian Gulf War may qualify for benefits. The American Legion commented that, because military operations continue in the Persian Gulf, research into Gulf War illnesses remains ongoing, and VA continues to receive disability claims for disabilities due to undiagnosed illnesses, the presumptive period should be extended indefinitely, not just to December 31, 2011. We will make no change based on this comment. Section 102(7) of the Persian Gulf War Veterans' Benefits Act states Congress' finding that further research must be undertaken to determine the causes of Gulf War veterans illnesses and that “pending the outcome of such research, veterans who are seriously ill as the result of such illnesses should be given the benefit of the doubt and be provided compensation to offset the impairment in earning capacities they may be experiencing.” In 38 U.S.C. 1118, Congress has prescribed an ongoing process for investigating the nature and causes of Gulf War veterans' illnesses and for prescribing presumptions of service connection for specific conditions associated with Gulf War service. The statutory scheme reflects the hope that further research and the procedures mandated by section 1118 may eventually diminish the need for the presumptions in section 1117. Accordingly, we believe that extending the presumptive period for a significant, but not indefinite period to permit further investigation is consistent with the goals of this statutory scheme. In 38 U.S.C. 1117(b), Congress provided the Secretary with discretion to prescribe a presumptive period based upon, among other things, a review of credible medical or scientific evidence. As stated in the interim final rule, the Secretary is extending the presumptive period to December 31, 2011 in order to provide more time for scientific and medical research regarding diseases and illnesses that may be related to service in the Southwest Asia theater of operations. Based on the current lack of scientific certainty surrounding the cause of illnesses suffered by Gulf War veterans, the Secretary's decision to extend the presumptive period until December 31, 2011, is within the discretion given to him by 38 U.S.C. 1117. Before the expiration of the presumptive period established by this rule, the Secretary may extend the presumptive period further if scientific uncertainty remains regarding the causes of Gulf War veterans illnesses. We appreciate the comments submitted on the interim final rule. Based on the rationale set forth in the interim final rule and in this document, we now affirm as a final rule the amendments made by the interim final rule. Administrative Procedure Act This document without any changes affirms amendments made by an interim final rule that is already in effect. Accordingly, we have concluded under 5 U.S.C. 553 that there is good cause for dispensing with a delayed effective date based on the conclusion that such procedure is impracticable, unnecessary, and contrary to the public interest. Paperwork Reduction Act This document contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). Regulatory Flexibility Act The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This final rule would not affect any small entities. Only VA beneficiaries could be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this final rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604. Executive Order 12866 Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Executive Order classifies a “significant regulatory action,” requiring review by the Office of Management and Budget
(OMB)unless OMB waives such review, as any regulatory action that is likely to result in a rule that may:
(1)Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;
(2)Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3)Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4)Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. The economic, interagency, budgetary, legal, and policy implications of this final rule have been examined and it has been determined to be a significant regulatory action under the Executive Order. Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532 that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any year. This final rule would have no such effect on State, local, and tribal governments, or on the private sector. Catalog of Federal Domestic Assistance Numbers and Titles The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.109, Veterans Compensation for Service-Connected Disability; and 64.110, Veterans Dependency and Indemnity Compensation for Service-Connected Death. List of Subjects in 38 CFR Part 3 Administrative practice and procedure, Claims, Disability benefits, Health care, Pensions, Radioactive materials, Veterans, Vietnam. Approved: August 27, 2007. Gordon H. Mansfield, Deputy Secretary of Veterans Affairs. Accordingly, the interim final rule amending 38 CFR part 3 that was published at 71 FR 75669 on December 18, 2006, is adopted as a final rule without change. [FR Doc. E7-23545 Filed 12-4-07; 8:45 am] BILLING CODE 8320-01-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2006-1021; FRL-8501-3] Approval and Promulgation of Air Quality Implementation Plans; Minnesota AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: EPA is approving State Implementation Plan
(SIP)revisions to sulfur dioxide (SO <sup>2</sup> ) requirements for Northern States Power Company, doing business as Xcel Energy, Inver Hills Generating Plant (Inver Hills), located in Inver Grove Heights, Dakota County, Minnesota. The revisions make the limits of the sulfur content in its fuel and its sulfur dioxide emissions more stringent, and prohibit the burning of residual fuel oil. The revisions allow the facility to use simpler methods to analyze the sulfur content of its fuel. Because the sulfur dioxide emission limits are being reduced, the air quality of Dakota County will be protected. DATES: This direct final rule will be effective February 4, 2008, unless EPA receives adverse comments by January 4, 2008. If adverse comments are received, EPA will publish a timely withdrawal of the direct final rule in the **Federal Register** informing the public that the rule will not take effect. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-OAR-2006-1021, by one of the following methods: 1. *http://www.regulations.gov:* Follow the on-line instructions for submitting comments. 2. *E-mail: mooney.john@epa.gov* . 3. *Fax:*
(312)886-5824. 4. *Mail:* John M. Mooney, Chief, Criteria Pollutant Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. 5. *Hand Delivery:* John M. Mooney, Chief, Criteria Pollutant Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. Such deliveries are only accepted during the Regional Office normal hours of operation, and special arrangements should be made for deliveries of boxed information. The Regional Office official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m. excluding Federal holidays. *Instructions:* Direct your comments to Docket ID No. EPA-R05-OAR-2006-1021. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at 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 www.regulations.gov or e-mail. The 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 www.regulations.gov 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 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 www.regulations.gov or in hard copy at the Environmental Protection Agency, Region 5, Air and Radiation Division, 77 West Jackson Boulevard, Chicago, Illinois 60604. This Facility is open from 8:30 am to 4:30 pm, Monday through Friday, excluding legal holidays. We recommend that you telephone Matt Rau, Environmental Engineer, at
(312)886-6524 before visiting the Region 5 office. FOR FURTHER INFORMATION CONTACT: Matt Rau, Environmental Engineer, Criteria Pollutant Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604,
(312)886-6524, *rau.matthew@epa.gov* . SUPPLEMENTARY INFORMATION: Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows: I. What is EPA Approving? II. What is the Background for this Action? III. What is EPA's Analysis of the State Submission? IV. What are the Environmental Effects of this Action? V. What Action is EPA Taking? VI. Statutory and Executive Order Reviews I. What is EPA Approving? EPA is approving into the SO 2 SIP for Minnesota revised conditions from the Inver Hills joint Title I/Title V document. The revisions lower the allowable sulfur content of its fuel and reduce the allowable limits of its SO 2 emissions. The revisions also allow a simplified method to analyze fuel sulfur content. EPA is also removing from the SIP any non-SIP related Title I conditions that were previously mistakenly incorporated into the SIP for Inver Hills. EPA is incorporating only the conditions in the joint Title I/Title V document labeled as “Title I Condition: State Implementation Plan for SO 2 NAAQS” into the Minnesota SIP. The joint Title I/Title V document is the Minnesota Air Emission Permit Number 03700015-003. II. What is the Background for This Action? A. What are the Revisions to the SIP? Xcel Energy's Inver Hills facility is a 440 Megawatt peak demand electrical generation plant. The plant has six generation units, turbines EU 001-EU 006, which can fire both natural gas and distillate fuel oil. The facility is located in the Pine Bend portion of the Minneapolis-Saint Paul SO 2 maintenance area. The SIP revisions reduce the limit for SO 2 emissions from the six turbines from 0.67 pounds per million British Thermal Units (lb/MMBTU) to 0.50 lb/MMBTU. This emission reduction is achieved by requiring the reduction of the sulfur content in the fuel from 0.64 percent by weight to 0.48 percent by weight. The SIP revision prohibits the use of residual fuel oil. If Inver Hills uses low sulfur fuel having a sulfur content of 0.10 percent by weight or less, Inver Hills can use a guarantee from a supplier as to the sulfur content of the fuel, and can use a simple fuel analysis option (ASTM Method D-1552) at the time of delivery. B. What Prior SIP Actions Are Pertinent to This Action? In 1980, Inver Hills was identified by the state of Minnesota as a culpable source in the Pine Bend area's nonattainment plan for the SO 2 National Ambient Air Quality Standards (NAAQS). On July 28, 1992, the Minnesota Pollution Control Agency
(MPCA)issued an Administrative Order for Inver Hills to address the source's contribution to the nonattainment problem. The SIP revision contained in the Administrative Order was approved by EPA into the SIP on April 14, 1994. The most recent SIP action was taken when the MPCA submitted the Title I SIP conditions in the original Title V permit, Air Emission Permit 03700015-001, to EPA in August 2002. EPA approved those Title I SIP conditions into the SIP as of July 2, 2004 (69 FR 31891). However, the materials incorporated by reference into the SIP included all Title I conditions, including certain conditions that were unrelated to the SIP. C. Has Public Notice Been Provided? Minnesota published public notice of the Inver Hills revisions on September 7, 2006. No comments were received during the comment period which ended on October 9, 2006. In the public notice, Minnesota stated it would hold a public hearing if one were requested during the comment period. This follows the alternative public participation process EPA approved on June 5, 2006 (71 FR 32274). For limited types of SIP revisions that the public has shown little interest in, a public hearing is not automatically required. If anyone requests a public hearing during the comment period, Minnesota will hold a public hearing. Because no one requested a public hearing, Minnesota did not hold a public hearing for this SIP revision. D. What Are Title I Conditions and Joint Title I/Title V Documents? SIP control measures were contained in permits issued to culpable sources in Minnesota until 1990 when EPA determined that limits in state-issued permits are not federally enforceable because the permits expire. Minnesota then issued permanent Administrative Orders to culpable sources in nonattainment areas from 1991 to February of 1996. Minnesota's consolidated permitting regulations, approved into the state SIP on May 2, 1995 (60 FR 21447), includes the term “Title I condition” which was written, in part, to satisfy EPA requirements that SIP control measures remain permanent. A “Title I condition” is defined as “any condition based on source-specific determination of ambient impacts imposed for the purposes of achieving or maintaining attainment with the national ambient air quality standard and which was part of the state implementation plan approved by EPA or submitted to the EPA pending approval under section 110 of the act * * *” The rule also states that “Title I conditions and the permittee's obligation to comply with them, shall not expire, regardless of the expiration of the other conditions of the permit.” Further, “any Title I condition shall remain in effect without regard to permit expiration or reissuance, and shall be restated in the reissued permit.” Minnesota has initiated using joint Title I/Title V documents as the enforceable document for imposing emission limitations and compliance requirements in SIPs. The SIP requirements in joint Title I/Title V documents submitted by MPCA are cited as “Title I conditions,” therefore ensuring that SIP requirements remain permanent and enforceable. EPA reviewed the State's procedure for using joint Title I/Title V documents to implement site-specific SIP requirements and found it to be acceptable under both Titles I and V of the Act (July 3, 1997 letter from David Kee, EPA, to Michael J. Sandusky, MPCA). Further, a June 15, 2006, letter from EPA to MPCA clarifies procedures to transfer requirements from Administrative Orders to joint Title I/Title V documents. III. What Is EPA's Analysis of the State Submission? Xcel Energy is receiving more stringent SO 2 limits on the generation units at the Inver Hills facility. However, it can take advantage of simplified methods of meeting fuel sulfur content and analysis requirements. The use of low sulfur fuel will ensure the tightened emission limits are met. A modeling analysis was not conducted for the Inver Hills revision because its emission limits will be more stringent. The actual emissions may not decrease, but the potential to emit will decrease with the SO 2 limit reductions. Modeling uses potential to emit in determining the impact on ambient air. Minnesota has noted that a July 2006 modeling analysis for the Pine Bend area showed that ambient SO 2 levels will remain below the standards and thus the area's air quality is protected. All significant sources of SO 2 emissions in the Pine Bend area including Inver Hills were in the July 2006 modeling analysis. IV. What Are the Environmental Effects of This Action? Sulfur dioxide causes breathing difficulties and aggravation of existing cardiovascular disease. It is also a precursor of acid rain and fine particulate matter formation. Sulfate particles are a major cause of visibility impairment in America. Acid rain damages lakes and streams impairing aquatic life and causes damage to buildings, sculptures, statues, and monuments. Sulfur dioxide also causes the loss of chloroform leading to vegetation damage. Ambient SO 2 levels are expected to be unchanged or to decrease because of the SIP revisions. Thus, the Pine Bend area of Dakota County, Minnesota is expected to remain in attainment of the SO 2 NAAQS. V. What Action Is EPA Taking? EPA is approving into the Minnesota SIP revised Title I conditions from the Inver Hills joint Title I/Title V document. EPA is also removing from the SIP for Inver Hills any non-SIP related Title I conditions that were previously mistakenly incorporated into the SIP. We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of this **Federal Register** publication, we are publishing a separate document that will serve as the proposal to approve the state plan if relevant adverse written comments are filed. This rule will be effective February 4, 2008 without further notice unless we receive relevant adverse written comments by January 4, 2008. If we receive such comments, we will withdraw this action before the effective date by publishing a subsequent document that will withdraw the final action. All public comments received will then be addressed in a subsequent final rule based on the proposed action. The EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. If we do not receive any comments, this action will be effective February 4, 2008. VI. Statutory and Executive Order Reviews Executive Order 12866: Regulatory Planning and Review 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. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use Because it is not a “significant regulatory action” under Executive Order 12866 or a “significant energy action,” 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). Regulatory Flexibility Act 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.). Unfunded Mandates Reform Act 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). Executive Order 13175: Consultation and Coordination With Indian Tribal Governments 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 (59 FR 22951, November 9, 2000). Executive Order 13132: Federalism 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 Clean Air Act. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks 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 approves a State rule implementing a Federal Standard. National Technology Transfer Advancement Act In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. 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. Paperwork Reduction Act 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.). 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 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. 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 by February 4, 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, Reporting and recordkeeping requirements, Sulfur oxides. Dated: November 20, 2007. Bharat Mathur, Acting Regional Administrator, Region 5. 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 Y—Minnesota 2. In § 52.1220 the table in paragraph
(d)is amended by revising the entry for “Xcel Energy, Inver Hills Generating Plant” to read as follows: § 52.1220 Identification of plan.
(d)* * * EPA-Approved Minnesota Source-Specific Permits Name of source Permit No. State effective date EPA approval date Comments * * * * * * * Xcel Energy—Inver Hills Generating Plant 03700015-003 10/27/06 12/5/07, [Insert page number where the document begins] Only conditions cited as “Title I condition: SIP for SO <sup>2</sup> NAAQS.” * * * * * * * [FR Doc. E7-23496 Filed 12-4-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2007-0479; FRL-8500-9] Approval and Promulgation of Air Quality Implementation Plans; Virginia; Amendments Extending the Applicability of Four Consumer and Commercial Product Regulations to the Fredericksburg Volatile Organic Compound
(VOC)Emissions Control Area AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: EPA is approving a State Implementation Plan
(SIP)revision submitted by the Commonwealth of Virginia. This revision consists of amendments to extend the geographic applicability of four consumer and commercial product regulations—Portable Fuel Container Spillage, Mobile Equipment Repair and Refinishing Operations, Architectural and Industrial Maintenance Coatings, and Consumer Products—to the Fredericksburg VOC Emissions Control Area. These amendments are necessary to implement VOC contingency measures within the Fredericksburg Area. The revision also incorporates by reference two additional test methods and procedures needed for Virginia's Architectural and Industrial Maintenance Coatings Rule. EPA is approving this revision to the Virginia SIP in accordance with the requirements of the Clean Air Act (CAA). DATES: *Effective Date:* This final rule is effective on January 4, 2008. ADDRESSES: EPA has established a docket for this action under Docket ID Number EPA-R03-OAR-2007-0479. All documents in the docket are listed in the *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 *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 Virginia Department of Environmental Quality, 629 East Main Street, Richmond, Virginia, 23219. FOR FURTHER INFORMATION CONTACT: Ellen Wentworth,
(215)814-2034, or by e-mail at *wentworth.ellen@epa.gov.* SUPPLEMENTARY INFORMATION: I. Background On September 12, 2007 (72 FR 52028), EPA published a notice of proposed rulemaking
(NPR)for the Commonwealth of Virginia. The NPR proposed the approval of amendments extending the geographic applicability of four consumer and commercial product regulations to the Fredericksburg VOC Emissions Control Area. The formal SIP revision was submitted by the Commonwealth of Virginia on May 14, 2007. II. Summary of the SIP Revision The May 14, 2007 SIP revision contained regulation amendments to 9 VAC 5 Chapter 40 that extended the geographic applicability of four consumer and commercial product regulations—Portable Fuel Container Spillage, Mobile Equipment Repair and Refinishing, Architectural and Industrial Maintenance Coatings, and Consumer Products—into the new Fredericksburg VOC Emissions Control Area established in 9 VAC 5-20-206 (March 2, 2007, 72 FR 9441). These regulations had formerly applied only in the Northern Virginia VOC Emissions Control Area, and were based on the Ozone Transport Commission
(OTC)model rules. The OTC developed control measures into model rules for a number of source categories and estimated emission reduction benefits from implementing those model rules. These regulations are necessary to implement VOC contingency measures within the Fredericksburg VOC Emissions Control Area. The revision also adds six additional specialty coatings to the Architectural and Industrial Maintenance Coatings regulation. Other specific requirements of Virginia's SIP revision and the rationale for EPA's proposed action are explained in the NPR and will not be restated here. No public comments were received on the NPR. III. General Information Pertaining to SIP Submittals From the Commonwealth of Virginia In 1995, Virginia adopted legislation that provides, subject to certain conditions, for an environmental assessment (audit) “privilege” for voluntary compliance evaluations performed by a regulated entity. The legislation further addresses the relative burden of proof for parties either asserting the privilege or seeking disclosure of documents for which the privilege is claimed. Virginia's legislation also provides, subject to certain conditions, for a penalty waiver for violations of environmental laws when a regulated entity discovers such violations pursuant to a voluntary compliance evaluation and voluntarily discloses such violations to the Commonwealth and takes prompt and appropriate measures to remedy the violations. Virginia's Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from disclosure documents and information about the content of those documents that are the product of a voluntary environmental assessment. The Privilege Law does not extend to documents or information
(1)that are generated or developed before the commencement of a voluntary environmental assessment;
(2)that are prepared independently of the assessment process;
(3)that demonstrate a clear, imminent and substantial danger to the public health or environment; or
(4)that are required by law. On January 12, 1998, the Commonwealth of Virginia Office of the Attorney General provided a legal opinion that states that the Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege to documents and information “required by law,” including documents and information “required by Federal law to maintain program delegation, authorization or approval,” since Virginia must “enforce Federally authorized environmental programs in a manner that is no less stringent than their Federal counterparts* * * * .” The opinion concludes that “[r]egarding § 10.1-1198, therefore, documents or other information needed for civil or criminal enforcement under one of these programs could not be privileged because such documents and information are essential to pursuing enforcement in a manner required by Federal law to maintain program delegation, authorization or approval.” Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by Federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any Federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with Federal law, which is one of the criteria for immunity.” Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its program consistent with the Federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on Federal enforcement authorities, EPA may at any time invoke its authority under the CAA, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the Clean Air Act is likewise unaffected by this, or any, state audit privilege or immunity law. IV. Final Action EPA is approving a revision to the Commonwealth of Virginia SIP, extending the geographic applicability of four consumer and commercial product regulations—Portable Fuel Container Spillage, Mobile Equipment Repair and Refinishing Operations, Architectural and Industrial Maintenance Coatings, and Consumer Products—to the Fredericksburg VOC Emissions Control Area. EPA is also approving the incorporation by reference of two additional test methods and procedures needed for Virginia's architectural and Industrial Maintenance Coatings Rule. V. Statutory and Executive Order Reviews A. General Requirements 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 requirement, 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 approves a state rule implementing a Federal standard. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. 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.* ). 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 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** . This rule 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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by *February 4, 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, expanding the geographic applicability of four consumer and commercial product regulations to the Fredericksburg VOC Emissions Control Area, 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, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds. Dated: November 20, 2007. Donald S. Welsh, Regional Administrator, Region III. 40 CFR part 52 is amended as follows: PART 52—[AMENDED] 1. The authority citation for 40 CFR part 52 continues to read as follows: Authority: 42 U.S.C. 7401 *et seq.* Subpart VV—Virginia 2. In § 52.2420, the table in paragraph
(c)is amended by revising the entries for Chapter 40, Part II, Sections 5-40-5700, 5-40-5720, 5-40-5750, 5-40-6970, 5-40-7050, 5-40-7120, 5-40-7130, 5-40-7140, 5-40-7210, 5-40-7240, 5-40-7250, 5-40-7260, 5-40-7270, 5-40-7300, 5-40-7330, and 5-40-7360. The table in paragraph
(e)is amended by adding an entry for Documents Incorporated by Reference after the eighth existing entry for Documents Incorporated by Reference. The amendments read as follows: § 52.2420 Identification of plan.
(c)* * * EPA-Approved Virginia Regulations and Statutes State citation (9 VAC 5) Title/subject State effective date EPA approval date Explanation [former SIP citation] * * * * * * * Chapter 40 Existing Stationary Sources (Part IV) * * * * * * * Part II Emissions Standards * * * * * * * Article 42 Portable Fuel Container Spillage (Rule 4-42) 5-40-5700 Applicability and designation of affected facility 10/04/06 12/05/07 [Insert page number where the document begins] Revision extends the applicability to include the Fredericksburg VOC Emissions Control Area. * * * * * * * 5-40-5720 Standard for volatile organic compounds 10/04/06 12/05/07 [Insert page number where the document begins] * * * * * * * 5-40-5750 Compliance schedules 10/04/06 12/05/07 [Insert page number where the document begins] * * * * * * * Article 48 Mobile Equipment Repair and Refinishing Operations (Rule 4-48) 5-40-6970 Applicability and designation of affected facility 10/04/06 12/05/07 [Insert page number where the document begins] Revision extends the applicability to include the Fredericksburg VOC Emissions Control Area * * * * * * * 5-40-7050 Compliance schedule 10/04/06 12/05/07 [Insert page number where the document begins] * * * * * * * Article 49 Architectural and Industrial Maintenance Coatings (Rule 4-49) 5-40-7120 Applicability and designation of affected facility 10/04/06 12/05/07 [Insert page number where the document begins] Revision extends the applicability to include the Fredericksburg VOC Emissions Control Area. 5-40-7130 Definitions 10/04/06 12/05/07 [Insert page number where the document begins] Revision adds definitions for the following: ASTM, Calcimine recoater,Concrete surface retarder, Conversion varnish, Impacted immersion coating, Nuclear coatings, and Thermoplasftic rubber coating and mastic. 5-40-7140 Standard for volatile organic compounds 10/04/06 12/05/07 [Insert page number where the document begins] Revision adds standards for the following categories: Calcimine recoaters, Conversion varnishes, Concrete surface retarder, Impacted immersion coatings, Nuclear coatings, and Thermoplastic rubber coating and mastic. * * * * * * * 5-40-7210 Compliance schedules 10/04/06 12/05/07 [Insert page number where the document begins] * * * * * * * Article 50 Consumer Products (Rule 4-50) 5-40-7240 Applicability 10/04/06 12/05/07 [Insert page number where the document begins] Revision extends the applicability to include the Fredericksburg VOC Emissions Control Area. 5-40-7250 Exemptions 10/04/06 12/05/07 [Insert page number where the document begins] 5-40-7260 Definitions 10/04/06 12/05/07 [Insert page number where the document begins] 5-40-7270 Standard for volatile organic compounds 10/04/06 12/05/07 [Insert page number where the document begins] * * * * * * * 5-40-7300 Administrative requirements 10/04/06 12/05/07 [Insert page number where the document begins] * * * * * * * 5-40-7330 Compliance schedules 10/04/06 12/05/07 [Insert page number where the document begins] * * * * * * * 5-40-7360 Notification, records and reporting 10/04/06 12/05/07 [Insert page number where the document begins]
(e)* * * Name of non-regulatory SIP revision Applicable geographic area State submittal date EPA approval date Additional Explanation * * * * * * * Documents Incorporated by Reference (9 VAC 5-20-21, Paragraphs E.4.a.
(21)and (22)). Fredericksburg VOC Emissions Control Area Designated in 9 VAC 5-20-206 05/14/07 12/05/07 [Insert page number where the document begins] State effective date is 10/04/06. * * * * * * * [FR Doc. E7-23386 Filed 12-4-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 52 and 97 [EPA-R05-OAR-2007-0390; FRL-8501-1] Approval of Implementation Plans; Ohio; Clean Air Interstate Rule AGENCY: Environmental Protection Agency (EPA). ACTION: Withdrawal of direct final rule. SUMMARY: Due to the receipt of an adverse comment, the EPA is withdrawing the October 16, 2007 (72 FR 58546), direct final rule approving the State of Ohio's September 26, 2007, request to revise the Ohio State Implementation Plan
(SIP)by incorporating provisions related to the implementation of EPA's Clean Air Interstate Rule (CAIR). In the direct final rule, EPA stated that if adverse comments were submitted by November 15, 2007, the rule would be withdrawn and not take effect. On November 9, 2007, EPA received a comment. EPA believes this comment is adverse and, therefore, EPA is withdrawing the direct final rule. EPA will address the comment in a subsequent final action based upon the proposed action also published on October 16, 2007 (72 FR 58571). EPA will not institute a second comment period on this action. DATES: The direct final rule published at 72 FR 58546 on October 16, 2007, is withdrawn as of December 5, 2007. FOR FURTHER INFORMATION CONTACT: John Paskevicz, Engineer, Criteria Pollutant Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604,
(312)886-6084, *paskevicz.john@epa.gov* . List of Subjects 40 CFR Part 52 Environmental protection, Air pollution control, Electric utilities, Incorporation by reference, Intergovernmental relations, Nitrogen oxides, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur dioxide. 40 CFR Part 97 Environmental protection, Administrative practice and procedure, Air pollution control, Electric utilities, Intergovernmental relations, Nitrogen oxides, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur dioxide. Authority: 42 U.S.C. 7401 *et seq.* Dated: November 23, 2007. Gary Gulezian, Acting Regional Administrator, Region 5. Accordingly, the amendments to 40 CFR 52.1870 and part 97 which were published in the **Federal Register** on October 16, 2007 (72 FR 58546) on pages 58552-58553 are withdrawn as of December 5, 2007. [FR Doc. E7-23504 Filed 12-4-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 81 [EPA-R03-OAR-2006-0353; EPA-R03-OAR-2007-0476; EPA-R03-OAR-2005-VA-0007; EPA-R03-OAR-2005-VA-0013; EPA-R03-OAR-2005-0548; EPA-R03-OAR-2006-0485; EPA-R03-OAR-2006-0682; EPA-R03-OAR-2006-0692; EPA-R03-OAR-2006-0817; FRL-8500-8] Approval and Promulgation of Air Quality Implementation Plans; Maryland, Pennsylvania, Virginia, West Virginia; Redesignation of 8-Hour Ozone Nonattainment Areas to Attainment and Approval of the Areas' Maintenance Plans and 2002 Base-Year Inventories; Correction AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule; correcting amendment. SUMMARY: This document corrects an error in the part 81 tables of a series of final rules pertaining to EPA's approval of ozone redesignation requests for Kent and Queen Anne, Erie, Fredericksburg, Shenandoah, Charleston, Parkersburg-Marietta, Steubenville-Weirton, Wheeling, and Huntington-Ashland 8-hour ozone nonattainment areas. The requests to redesignate the areas from nonattainment to attainment were submitted by Maryland, Pennsylvania, Virginia, and West Virginia. EFFECTIVE DATE: December 5, 2007. FOR FURTHER INFORMATION CONTACT: Irene Shandruk,
(215)814-2166 or by e-mail at *shandruk.irene@epa.gov.* SUPPLEMENTARY INFORMATION: Throughout this document wherever “we” or “our” are used we mean EPA. The following table is a summary of the dates on which we published final rulemaking documents announcing our approval of three simultaneous actions for nine areas:
(1)Redesignation from nonattainment to attainment of 8-hour ozone national ambient air quality standard (NAAQS);
(2)approval of the areas' maintenance plans, and
(3)approval of the emissions 2002 base-year inventories and mobile budgets. The effective dates for the three actions were announced in the DATES section as being 30 days from the date of publication. State Nonattainment area Date of publication FRN Effective date Maryland Kent & Queen Anne's December 22, 2006 71 FR 76920 January 22, 2007. Pennsylvania Erie October 9, 2007 72 FR 57207 November 8, 2007. Virginia Fredericksburg December 23, 2005 70 FR 76165 January 23, 2006. Shenandoah January 3, 2006 71 FR 24 February 2, 2006. West Virginia Charleston July 11, 2006 71 FR 39001 August 10, 2006. Huntington-Ashland September 15, 2006 71 FR 54421 October 16, 2006. Parkersburg-Marietta May 8, 2007 72 FR 25967 June 7, 2007. Steubenville-Weirton May 14, 2007 72 FR 27060 June 13, 2007. Wheeling May 15, 2007 72 FR 27247 June 14, 2007. The corresponding effective dates in the 40 CFR part 81 tables for each nonattainment area should have also been 30 days from date of publication, but were inadvertently established as the dates of publication. This action corrects the erroneous effective date in part 81 for each of the above listed areas. In the rule documents published in the **Federal Register** on the effective dates given in the above table, the part 81 tables for the nonattainment areas listed in the above table are corrected by revising the entry for the effective designation date for these areas from the date of publications given in the above table to the effective dates given in the above table (for example, for Kent & Queen Anne, corrected from December 23, 2006 to January 22, 2007). Section 553 of the Administrative Procedure Act, 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 today's rule final without prior proposal and opportunity for comment because this rule is not substantive and imposes no regulatory requirements, but merely corrects a citation in a previous action. Thus, notice and public procedure are unnecessary. We find that this constitutes good cause under 5 U.S.C. 553(b)(B). Statutory and Executive Order Reviews Under Executive Order (E.O.) 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and is therefore 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)). Because the agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the Administrative Procedures Act or any other statute as indicated in the Supplementary Information section above, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), or to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995
(UMRA)(Pub. L. 104-4). In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of UMRA. This rule also does 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), nor will it 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 governments, as specified by Executive Order 13132 (64 FR 43255, August 10, 1999). This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal standard. This technical correction action does not involve technical standards; 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. The rule also does not involve special consideration of environmental justice related issues as required by Executive Order 12898 (59 FR 7629, February 16, 1994). In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996). EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1998) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This rule does not impose an information collection burden under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). 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. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). As stated previously, EPA had made such a good cause finding, including the reasons therefore, and established an effective date of December 5, 2007. 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** . These corrections to the tables in 40 CFR 81.321, 81.339, 81.347 and 81.349 for Maryland, Pennsylvania, Virginia and West Virginia are not “major rules” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 81 Air pollution control, National parks, Wilderness areas. Dated: November 20, 2007. Donald S. Welsh, Regional Administrator, Region III. 40 CFR part 81 is amended as follows: PART 81—[AMENDED] 1. The authority citation for Part 81 continues to read as follows: Authority: 42 U.S.C. 7401 *et seq.* 2. In § 81.321, the table entitled “Maryland—Ozone (8-Hour Standard)” is amended by revising the entry for Kent and Queen Anne's Area to read as follows: § 81.321 Maryland. Maryland—Ozone (8-Hour Standard) Designated Area Designation a Date 1 Type Category/Classification Date 1 Type * * * * * * * Kent and Queen Anne's Area Kent County January 22, 2007 Attainment Queen Anne's County January 22, 2007 Attainment * * * * * * * a Includes Indian County located in each county or area, except otherwise noted. 1 This date is June 15, 2004, unless otherwise noted. 3. In § 81.339, the table entitled “Pennsylvania-Ozone (8-Hour Standard)” is amended by revising the entry for Erie, PA: Erie County to read as follows: § 81.339 Pennsylvania. Pennsylvania—Ozone (8-Hour Standard) Designated Area Designation a Date 1 Type Category/Classification Date 1 Type * * * * * * * Erie, PA: Erie County 11/8/2007 Attainment * * * * * * * a Includes Indian County located in each county or area, except otherwise noted. 1 This date is June 15, 2004, unless otherwise noted. 4. In § 81.347, the table entitled “Virginia—Ozone (8-Hour Standard)” is amended by revising the entries for Fredericksburg, VA and Madison and Page Cos. (Shenandoah NP), VA Area to read as follows: § 81.347 Virginia. Virginia—Ozone (8-Hour Standard) Designated Area Designation a Date 1 Type Category/Classification Date 1 Type * * * * * * * Fredericksburg, VA: City of Fredericksburg January 23, 2006 Attainment Spotsylvania County January 23, 2006 Attainment Stafford County January 23, 2006 Attainment Madison and Page Cos. (Shenandoah NP), VA area: Madison County
(part)February 2, 2006 Attainment Page County
(part)February 2, 2006 Attainment * * * * * * * a Includes Indian County located in each county or area, except otherwise noted. 1 This date is June 15, 2004, unless otherwise noted. 5. In § 81.349, the table entitled “West Virginia—Ozone (8-Hour Standard)” is amended by revising the entries for Charleston, WV; Huntington-Ashland, WV-KY; Parkersburg-Marietta WV-OH Area; Wheeling, WV-OH Area; and Steubenville-Weirton, OH-WV Area to read as follows: § 81.349 West Virginia. West Virginia—Ozone (8-Hour Standard) Designated Area Designation a Date 1 Type Category/Classification Date 1 Type * * * * * * * Charleston, WV: Kanawha County August 10, 2006 Attainment Putnam County August 10, 2006 Attainment Huntington-Ashland, WV-KY Cabell County October 16, 2006 Attainment Wayne County October 16, 2006 Attainment Parksburg-Marietta, WV-OH Area: Wood County June 7, 2007 Attainment Wheeling, WV-OH area: Marshall County June 14, 2007 Attainment Ohio County June 14, 2007 Attainment Steubenville-Weirton, OH-WV area: Brooke County June 13, 2007 Attainment Hancock County June 13, 2007 Attainment * * * * * * * a Includes Indian County located in each county or area, except otherwise noted. 1 This date is June 15, 2004, unless otherwise noted. [FR Doc. E7-23498 Filed 12-4-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 94 [EPA-HQ-OAR-2007-0120; FRL-8502-6] RIN 2060-A026 Change in Deadline for Rulemaking to Address the Control of Emissions From New Marine Compression-Ignition Engines at or Above 30 Liters per Cylinder AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: A February 2003 final rule established the first U.S. emission standards for new compression-ignition Category 3 marine engines, those with a per-cylinder displacement at or above 30 liters. It also established a deadline of April 27, 2007 for EPA to promulgate a second set of emission standards for these engines. This rulemaking schedule was intended to allow time to consider the state of technology for deeper emission reductions and the status of international action for more stringent standards. Since 2003 we have continued to gain a greater understanding of technical issues and assess the continuing efforts of manufacturers to apply advanced emission control technologies to these engines. In addition, we have continued to work with and through the International Maritime Organization toward more stringent emission standards that would apply to all new marine diesel engines on ships engaged in international transportation. Much of the information necessary to develop more stringent Category 3 marine diesel engines standards has become available only recently and we expect more information to come to light in the course of the current negotiations underway as part of the international process. EPA is therefore adopting a new deadline for the rulemaking to consider the next tier of Category 3 marine diesel engine standards. Under this new schedule, EPA would adopt a final rule by December 17, 2009. EPA has started this rulemaking process by publishing an Advance Notice of Proposed Rulemaking elsewhere in today's **Federal Register** . DATES: This rule is effective on January 4, 2008. ADDRESSES: All documents in the docket are listed in the www.regulations.gov index under Docket ID No. EPA-HQ-OAR-2007-0120. Some information listed in the index is not publicly available, such as confidential business information or other information for which 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 www.regulations.gov or in hard copy at the EPA Docket Center, EPA/DC, EPA West, Room 3334, 1301 Constitution Avenue, 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 Docket is
(202)566-1742. FOR FURTHER INFORMATION CONTACT: Michael Samulski, Assessment and Standards Division, Office of Transportation and Air Quality, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number:
(734)214-4532; fax number:
(734)214-4050; e-mail address: *samulski.michael@epa.gov* . SUPPLEMENTARY INFORMATION: I. Does This Action Apply to Me? This action will affect companies that manufacture, sell, or import into the United States new marine compression-ignition engines for use on vessels flagged or registered in the United States; companies and persons that make vessels that will be flagged or registered in the United States and that use such engines; and the owners or operators of such U.S. vessels. This action may also affect companies and persons that rebuild or maintain these engines. Affected categories and entities include the following: Category NAICS Code a Examples of potentially affected entities Industry 333618 Manufacturers of new marine diesel engines. Industry 336611 Manufacturers of marine vessels. Industry 811310 Engine repair and maintenance. Industry 483 Water transportation, freight and passenger. a North American Industry Classification System (NAICS). This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. To determine whether particular activities may be affected by this action, you should carefully examine the regulations. You may direct questions regarding the applicability of this action as noted in FOR FURTHER INFORMATION CONTACT . I. Background EPA published the intended change in the rulemaking schedule for Category 3 marine diesel engines as a direct final rule (72 FR 20948, April 27, 2007). We received adverse comments from six state and non-governmental organizations. As a result, we retracted the direct final rule and are proceeding with the rulemaking based on the proposal that was published concurrent with the direct final rule. Comments received on the direct final rule are therefore considered to be comments on the concurrent proposed rule. In this action we are announcing our decision to change the regulatory deadline as intended and responding to those comments. II. Summary of the Rule In this final rule we are extending the regulatory deadline for issuing a final rule setting more stringent standards for Category 3 marine diesel engines to December 17, 2009. This additional time will allow us to better address significant remaining concerns about the emission control technologies and create a compliance program that ensures proper implementation of new standards. This approach will allow us to set standards that achieve the maximum emission reductions from these engines. We do not believe this extension will delay emission reductions from Category 3 marine diesel engines beyond what could be achieved by setting standards sooner. Instead, it creates the opportunity for the development and implementation of a more effective program for the longer term. Finally, this delay will allow us to take advantage of information that is being prepared for consideration by the International Maritime Organization as part of the ongoing negotiations to amend MARPOL Annex VI under the International Convention for the Prevention of Pollution from Ships. III. Basis for the Rule A. History of EPA's Category 3 Standards In February 2003, we adopted standards for new marine diesel engines with per-cylinder displacement at or above 30 liters per cylinder (also called Category 3 marine diesel engines; see 68 FR 9746, February 28, 2003). The program consisted of a two-part approach. First, we adopted near-term Tier 1 standards that went into effect in 2004 and were based on readily available control technology. Those standards are identical to the international standards adopted at the International Maritime Organization in MARPOL Annex VI. Second, we adopted regulations that set a schedule for a future rulemaking to assess and adopt an appropriate second tier of standards. We explained that it was appropriate to defer a final decision on the longer-term Tier 2 standard to a future rulemaking because there were several outstanding technical issues concerning the widespread commercial use of advanced control technologies on engines of this size. We highlighted the following concerns in the 2003 final rule: • Selective catalytic reduction has been widely used in stationary applications and there are now efforts underway to use this technology for marine applications. We expressed concerns that these systems may not be capable of working effectively during the low-speed and light-load operation typical of operation closest to port areas where emission control is most important. We also noted that this approach could lead to increased emissions of PM, especially direct sulfate PM. There was also a concern that high fuel sulfur levels could lead to premature wear of catalyst materials. • Various approaches for adding water to the combustion event were also cited as possible approaches to reduce NO <sup>X</sup> emissions by 50 to 80 percent. There were concerns that adding water could increase engine wear with its low lubricity and increase PM emissions (by decreasing combustion temperatures). We also noted that new approaches to adding water—humidification and steam injection—held promise for substantially greater control of NO <sup>X</sup> emissions. • We raised several questions related to implementation and compliance provisions that would be appropriate with a new set of standards. For example, we need to develop an effective approach to address off-cycle emissions and uncertainties related to test-fuel specifications and PM measurement methods relative to the high sulfur concentrations typical of in-use fuels. We also raised the possible need to create a compliance program that would allow for emission controls to be disabled for operation on the open ocean and restored upon entry into some defined boundary representing U.S. coastal waters. These issues are complicated and need time for resolution. We expected new information to become available with respect to
(1)new developments as manufacturers continue to make various improvements with respect to emission aftertreatment;
(2)data or experience from recently initiated in-use installations using advanced technologies; and
(3)information from longer-term in-use experience that would be helpful for evaluating the long-term durability of emission controls. The revision of the deadline for Tier 2 of the standards for new Category 3 marine diesel engine standards is permitted by the Clean Air Act. Clean Air Act section 213(a)(3) requires EPA to adopt and periodically revise regulations that contain standards concerning certain pollutants reflecting the greatest degree of emission reductions achievable through the application of technology that will be available, taking into consideration the availability and costs of the technology, and noise, energy, safety factors and existing motor vehicle standards. EPA's strategy toward achieving the maximum level of emission control from Category 3 marine diesel engines is consistent with those statutory requirements. See *Bluewater Network* v. *EPA* , 372 F. 3d 404 D.C. Cir. (2004). B. Need for Revised Schedule Deferring the Tier 2 standards to a second rulemaking has allowed us to obtain more information on the implementation of advanced technologies. Toward that end, we are publishing an Advance Notice of Proposed Rulemaking elsewhere in today's **Federal Register** in which we describe the new information and our current thinking with regard to potential new requirements for Category 3 marine diesel engines. This new information comes from field experiences related to the continuing pilot projects to test new technologies, several recently published technical papers, and ongoing negotiations in the context of developing MARPOL Annex VI standards. This includes a better understanding of the capabilities and constraints associated with selective catalytic reduction, the potential for seawater scrubbers to control PM emissions, and the possibility of relying on the use of distillate fuel as a part of the overall approach to reducing emissions. For example, it appears that selective catalytic reduction can be quite tolerant of high fuel sulfur levels, but reactors would need to be physically larger to avoid sulfur-related problems. Also, pairing selective catalytic reduction with oxidation catalysts allows for reactivity at substantially lower exhaust temperatures. This would help to address the concern for controlling emission at light engine loads. As we prepare a proposed rule to set standards based on advanced emission control technologies, we intend to resolve remaining questions for crafting a complete set of requirements. This will include consideration of testing requirements that reflect the need for engines using selective catalytic reduction to control emissions at light engine loads typical of operation in port areas. We will also consider whether further technological developments with selective catalytic reduction and water-based technologies will allow us to pursue PM emission standards more stringent than we are currently contemplating. Control of PM and SO <sup>X</sup> emissions depends on a combination of using distillate fuel and adding seawater scrubbers for removing emissions from engines that burn residual fuel. EPA will be separately pursuing the appropriate designations under MARPOL Annex VI such that all vessels would need to either use distillate fuel or achieve an equivalent level of emission control with seawater scrubbers. We intend to address certification requirements for seawater scrubbers in the rulemaking proposal for setting emission standards for Category 3 marine diesel engines. In addition, the proposal will address remaining questions for applying such standards to the current fleet in addition to new vessels, and for disposing of emissions removed from the exhaust gases, including the possible negative impacts on water quality for discharged wastewater. The proposed rule will also rely on development and use of new analytic tools to assess the costs and benefits of alternative emission control strategies, especially related to at-sea emissions and how they are transported to shore. Additional time will also allow us to take advantage of the ongoing negotiations for amendments to MARPOL Annex VI. When we finalized our Tier 1 standards in 2003, we anticipated that negotiations for the next round of international standards would begin shortly thereafter. Due to many delays, Members of the Convention did not agree to begin negotiations until July 2006, and the first round of negotiations did not occur until November 2006. These negotiations are expected to conclude in October 2008. These negotiations provide a key forum for sharing information on the performance of current installations. In addition, the IMO Secretary General has commissioned an experts group to examine control alternatives for PM and SO <sup>X</sup> emissions; this information will also be important for developing the national standards. EPA is involved in these negotiations as a member of the U.S. delegation to IMO. All these rulemaking issues are described in more detail in the Advance Notice of Proposed Rulemaking published elsewhere in today's **Federal Register** . This Advance Notice initiates the rulemaking process for adopting a more stringent set of standards for Category 3 marine diesel engines. C. New Schedule EPA remains committed to developing and proposing Tier 2 emission standards for Category 3 marine diesel engines. Advanced technology solutions are available or under development for these engines. However, it is necessary to resolve the questions described above before we are ready to propose a program with appropriate Tier 2 emission standards for these engines. Our commitment to Tier 2 standards is evidenced by our position at the IMO and in the Advance Notice of Proposed Rulemaking. Specifically, as part of the process for setting new emission standards under IMO, the United States submitted a paper to the April 2007 BLG Sub-Committee meeting (called BLG-11) setting out an approach for substantially reducing emissions from marine diesel engines. 1 If adopted, these standards could achieve significant reductions in NO <sup>X</sup> , particulate matter (PM), and oxides of sulfur (SO <sup>X</sup> ) emissions from marine vessels. 2 This framework formed the basis of the approach we are currently pursuing for an EPA rulemaking under the Clean Air Act to establish Tier 2 standards for Category 3 marine diesel engines, as described in the Advance Notice of Proposed Rulemaking. We expect the information we receive during this international process and as comments on the Advance Notice to provide very useful information in addressing our remaining concerns. 1 “Revision of the MARPOL Annex VI, the NO <sup>X</sup> Technical Code and Related Guidelines; Development of Standards for NO <sup>X</sup> , PM, and SO <sup>X</sup> ,” subitted by the United States, BLG 11/5, Sub-Committee on Bulk Liquids and Gases, 11th Session, Agenda Item 5, February 9, 2007, Docket ID EPA-HQ-OAR-2007-0121-0034. This document is also available on our *Web site: http://www.epa.gov/otaq/oceanvessels.com.* 2 “Revision of MARPOL Annex VI, the NO <sup>X</sup> , PM, and SO <sup>X</sup> ,” Submitted by the United States to the Sub-Committee on Bulk Liquids and Gases, 11th Session, 2007. We do not believe this extension will delay emission reductions from Category 3 marine diesel engines beyond what could be achieved by setting standards sooner. If we would adopt emission standards earlier, we would need to allow several years of lead time to give manufacturers opportunity to work out remaining technological issues in designing engines with advanced emission control technologies for all sizes and types of vessels. Manufacturers have continued to make progress in developing these technologies in the meantime, which will help us tailor requirements to what emission reductions are achievable and should allow us to adopt a program with shorter lead time relative to the final rule setting these emission standards. Any foregone emission reductions from delaying the implementation of emission standards would likely be offset by our ability to set more stringent standards based on the additional information that is available by setting standards at the later date. In sum, the delay in issuing the final rule for more stringent emission standards for Category 3 marine diesel engines is reasonable given the need to address certain technical issues and collect further information. We believe there will be no significant foregone emission reductions resulting from the delayed rulemaking schedule. In contrast, the additional time allows the opportunity to develop and implement a more effective program for the longer term. In recognition of the current situation, we are taking this action to establish a new rulemaking deadline that will facilitate our ability to adopt emission standards consistent with the statutory directive, while advocating adoption of the same controls as part of the international process. In this action we are adopting a new deadline of December 17, 2009 for a final rule that will address additional emission standards for Category 3 marine diesel engines as appropriate under section 213(a)(3) of the Clean Air Act. IV. Summary and Analysis of Comments A. Summary of Comments Commenters pointed out that Category 3 marine diesel engines are significant and growing contributors to air pollution in the United States. This included reference to various EPA estimates and was supplemented by several estimates for specific areas. Several commenters pointed out the acute need for reduced emissions from these engines in California, particularly in the South Coast Air Basin. For example, over half of current or projected levels of SO <sup>x</sup> and diesel PM emissions in the South Coast Air Basin are estimated to come from marine vessels (or all port-related sources). SO <sup>x</sup> emissions from marine vessels in particular would need to be reduced by about 90 percent in the next few years for the South Coast Air Basin to reach timely attainment of the air quality standard for PM <sup>2.5</sup> . The South Coast Basin is also home to the Ports of Los Angeles and Long Beach, which are claimed to be the entry point for 40 percent of the nation's goods, with cargo throughput projected to triple by 2025. Santa Barbara County, California was noted as another particular concern, where 75 percent of local NO <sup>X</sup> emissions are projected to come from marine vessels, even though there are no commercial ports within county boundaries. One commenter referenced a finding that 70 percent of global shipping emissions occur within 400 kilometers of shore, where pollution transport may range from 400 to 1200 kilometers inland. Commenters emphasized that the emissions from Category 3 marine diesel engines contribute to serious public health and environmental problems. Commenters cited the EPA finding that diesel exhaust is a likely human carcinogen. Diesel particulate matter, ozone, SO <sup>x</sup> , and air toxic emissions were identified as substantial causes of environmental degradation, illness, and/or death. Commenters noted that emissions from marine diesel engines also raise concerns for environmental justice, since the pollution effects fall disproportionately on the relatively low-income residential areas surrounding ports and transportation corridors. Commenters cited Clean Air Act section 213 and EPA's 1994 and 1998 findings to establish the significance of emissions from nonroad engines in general and Category 3 marine diesel engines specifically as demonstration that EPA had a mandatory duty to set technology-forcing emission standards for these engines. Commenters further maintained that missing the regulatory deadline violated EPA's repeated statements committing to take final action on the schedule reflected in the regulation. Commenters noted that in similar circumstances the District Court of the District of Columbia compelled EPA to take a final action based on a regulatory deadline EPA had earlier adopted as part of the effort to address hazardous air pollutants from motor vehicles. Commenters further reasoned that the court decision upholding the sufficiency of the Tier 1 standards adopted in February 2003 depended on EPA's commitment to adopt more stringent emission standards for these engines by the established deadline. Commenters claimed that delaying implementation of emission standards based on the need for more time to evaluate potential emission controls is without merit and outside the scope of EPA's rulemaking authority. Rather, commenters view Clean Air Act section 213 as requiring EPA to establish technology-forcing standards based on projected future advances in pollution control capabilities. Commenters further argue that the necessary advances for low-emission technologies for these engines have already occurred and these technologies are widely used in commercial applications today, and that EPA has provided no reasoned basis describing why the originally adopted schedule was not sufficient to address any remaining technical concerns related to emission control technologies. For example, commenters cited EPA's report of more than 300 marine engines operating worldwide with selective catalytic reduction, including oceangoing vessels. Some commenters also disagreed with the logic of EPA's argument that setting intermediate-stringency standards would prevent more effective long-term standards, noting Congress's intent for periodic review and update of nonroad emission standards to reflect the evolutionary nature of emission control technology. Commenters also pointed out that more stringent emission controls are urgently needed, given the large number of ships expected to be built over the coming years and the difficulty of retrofitting vessels to reduce emissions. Commenters also posit that it is impermissible and inappropriate for EPA to allow international negotiations to nullify its obligations under the Clean Air Act. Commenters point out that Clean Air Act section 213 does not allow for foreign-policy considerations to serve as the basis for determining whether or how to set emission standards for nonroad engines, and that the Supreme Court recently reinforced this principle in the decision related to greenhouse gas emissions. This was presented as an inappropriate means of shifting power from the Congress to the Executive Branch. Commenters further maintain that EPA has failed to explain how emission standards adopted for the United States under the Clean Air Act would hamper international negotiations (or how the specific and feasible standards EPA has recommended for consideration at IMO lack information needed for pursuing standards under U.S. law). They emphasized other examples of international agreements that followed implementation of domestic regulations in the United States, and argued that the delays in adoption of international standards for marine diesel engines were in fact a basis for EPA to pursue separate requirements. Aside from a general skepticism that the IMO process would lead to meaningful emission reductions from these engines, commenters promoted the contrary view that rigorous U.S. emission standards would provide the political and technical foundation for international action regarding Category 3 marine diesel engines, and that EPA has missed out on an opportunity to demonstrate to the IMO that the United States is serious about reducing emissions from large marine vessels and will act unilaterally if the IMO does not. Commenters recommended that EPA pursue emission standards based on the recent U.S. proposal for consideration under the IMO process. Commenters noted that the decision to delay the deadline for setting new emission standards also postpones EPA's promised decision regarding the authority to apply U.S. emission standards to engines on foreign-flagged vessels. Commenters also made the following arguments to emphasize that EPA should decide affirmatively to apply emission standards to engines on foreign-flagged vessels: • Clean Air Act section 213 requires EPA to set emission standards for all classes of nonroad engines that contribute to air pollution in the United States, without distinguishing between domestic and foreign engines. • EPA has repeatedly acknowledged that foreign-flagged vessels account for the clear majority of emissions from Category 3 marine diesel engines. • Court decisions have established that foreign-flagged vessels in U.S. ports and water are subject to U.S. regulations other than those pertaining to a ship's “internal management and affairs.” • International law explicitly protects the right of the U.S. to regulate foreign-flagged ships in U.S. ports and waters. • As described above for emission standards, the court upheld EPA's refusal to decide whether to regulate foreign flagged vessels on the basis that EPA promised to address the issue in its 2007 rulemaking. Commenters concluded by emphasizing their interest in seeing EPA establish and commit to a firm and timely deadline to develop and implement stringent emission standards for Category 3 marine diesel engines, with rulemaking and implementation schedules expedited as much as possible to address EPA's legal obligations and the compelling air quality needs associated with these standards. B. Analysis of Comments We are mindful of the extent to which Category 3 marine diesel engines contribute to air pollution in coastal and inland areas of the United States. We do not disagree with the general characterization of the emission contribution or health and environmental impacts described by commenters. However, we believe that amending the regulatory deadline to allow more time to address several remaining technical issues and collect some additional information is reasonable and consistent with our authority under the statute. The February 2003 final rule fulfilled our statutory obligation under Clean Air Act section 213 to set standards for Category 3 marine diesel engines. In *Bluewater Network* v. *EPA* , 372 F. 3d 404 D.C. Cir. (2004), the Court upheld EPA's rulemaking as having met the statutory requirement to establish standards that achieve the greatest degree of emission reduction. As a result, we disagree with the comments suggesting that we have failed to meet our mandatory statutory duty to set initial emission standards. We have an additional obligation to periodically revise the emission standards to ensure that they reflect the greatest degree of emission control considering various statutory factors. We set a schedule for producing a new rulemaking to adopt these more stringent emission standards by April 2007 but have found that this did not allow sufficient time for completion, as described above. The delay rulemaking schedule we are adopting in this notice is reasonable in light of these issues and is consistent with Congress' intent that EPA consider the availability of technologies that can achieve the desired reductions, as well as the necessary lead time, cost, noise, energy and safety issues with adopting such standards. As part of the process for setting new emission standards under IMO, the United States submitted a paper to the April 2007 BLG Sub-Committee meeting (called BLG-11) setting out an approach for substantially reducing emissions from marine diesel engines. 3 In parallel with this development toward a new set of international standards, we are initiating a rulemaking under the Clean Air Act to adopt these standards for the United States by publishing an Advance Notice of Proposed Rulemaking elsewhere in today's **Federal Register** . 3 “Revision of the MARPOL Annex VI, the NO <sup>X</sup> Technical Code and Related Guidelines; Development of Standards for NO <sup>X</sup> , PM, and SO <sup>X</sup> ,” submitted by the United States, BLG 11/5, Sub-Committee on Bulk Liquids and Gases, 11th Session, Agenda Item 5, February 9, 2007, Docket ID EPA-HQ-OAR-2007-0121-0034. This document is also available on our Web site: *http://www.epa.gov/otaq/oceanvessels.com* . We believe there has been great progress toward establishing the feasibility of controlling NO <sup>X</sup> , SO <sup>X</sup> , and PM emissions from these engines. Laboratory and in-field pilot demonstrations have significantly advanced the development of emission control technologies and allowed for relatively near-term projections for deploying these technologies in commercial service. These developments have allowed us to advocate specific emission targets as participating members of IMO in the effort to adopt more stringent emission standards. These targets are also the basis of our Advance Notice of Proposed Rulemaking. As described in the Advance Notice, we are still concluding resolution of the technological issues described above. We also expect to receive information through the international process and as comment on the Advance Notice of Proposed Rulemaking to help us address these remaining concerns. While we are supporting the efforts in an international forum to set global emission standards, we are not deferring to that process in pursuing emission standards under the Clean Air Act. By initiating our own rulemaking to set new emission standards, we are pursuing an approach in which harmonized U.S. and global standards would be developed in parallel. While we are mindful of the timing of the international process and the state of these negotiations, the reasons described above for taking additional time to adopt a new round of emission standards hinge on the factors specified by Congress for considering the timing for implementing new emission standards, especially for the feasibility, lead time, and costs associated with new emission controls. Regarding the question of applying emission standards to foreign-flagged vessels, we understand the positions expressed by commenters, as well as the contrary views expressed by commenters in previous rulemaking activity, and will be taking these concerns into account as we pursue a decision on this issue, which we will describe with supporting rationale in the proposal for setting emission standards for these engines. The Advance Notice of Proposed Rulemaking is the next step toward developing more stringent emission standards for Category 3 marine diesel engines under the Clean Air Act. We intend to pursue these aggressive emission reductions, both in the EPA rulemaking and in the international process. The revised regulatory deadline included in this final rule indeed reflects a delay from the original April 2007 target, but we believe the revised schedule will allow for a thorough consideration of a wide range of important issues that need to be addressed before we can adopt an appropriate set of requirements for these engines. We continue to believe that pursuing resolution of these issues in an EPA rulemaking in parallel with the ongoing international negotiations will be the best path to leverage the most effective program for reducing the emissions impact from Category 3 marine diesel engines on U.S. air quality. V. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review Under section (3)(f)(1) Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether the regulatory action is “significant” and therefore subject to review by the Office of Management and Budget
(OMB)and the requirements of this Executive Order. This final rule has been sent to OMB for review under Executive Order 12866 and any changes made in response to OMB recommendations have been documented in the docket for this action. B. Paperwork Reduction Act This action does not impose any new information collection burden. This final rule merely changes the regulatory schedule for a rulemaking to address emissions from Category 3 marine diesel engines. However, the Office of Management and Budget
(OMB)has previously approved the information collection requirements contained in the existing regulations in 40 CFR part 94 under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 *et seq.* and has assigned OMB control number 2060-0287, EPA ICR number 1684.10. A copy of the approved Information Collection Request
(ICR)may be obtained from Susan Auby, Collection Strategies Division; U.S. Environmental Protection Agency (2822T); 1200 Pennsylvania Ave., NW., Washington, DC 20460 or by calling
(202)566-1672. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. 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 Administrative Procedures Act 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 final rule on small entities, a small entity is defined as:
(1)A small business that meets the definition for business based on SBA size standards 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; and
(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. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives “which minimize any significant economic impact of the rule on small entities.” 5 U.S.C. 603 and 604. Thus, an agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect on all of the small entities subject to the rule. This final rule merely changes the regulatory schedule for a rulemaking to address emissions from Category 3 marine engines. We have therefore concluded that this final rule will relieve regulatory burden for all affected small businesses. 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 EPA to identify and consider a reasonable number of regulatory alternatives and to 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 EPA 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 of why such an alternative was adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it 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 rule contains no Federal mandates for State, local, or tribal governments, or the private sector as defined by the provisions of Title II of the UMRA. The rule imposes no enforceable duties on any of these governmental entities. This rule contains no regulatory requirements that would significantly or uniquely affect small governments. EPA has determined that this rule contains no Federal mandates that may result in expenditures of more than $100 million to the private sector in any single year. This final rule merely changes the regulatory schedule for a rulemaking to address emissions from Category 3 marine engines. This rule is not subject to the requirements of sections 202 and 205 of UMRA. 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” are 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.” Under Section 6 of Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law, unless the Agency consults with State and local officials early in the process of developing the regulation. Section 4 of the Executive Order contains additional requirements for rules that preempt State or local law, even if those rules do not have federalism implications ( *i.e.* , the rules 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). Those requirements include providing all affected State and local officials notice and an opportunity for appropriate participation in the development of the regulation. If the preemption is not based on express or implied statutory authority, EPA also must consult, to the extent practicable, with appropriate State and local officials regarding the conflict between State law and Federally protected interests within the agency's area of regulatory responsibility. This 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. This final rule merely changes the regulatory schedule for a rulemaking to address emissions from Category 3 marine diesel engines. Thus, Executive Order 1312 does not apply to this rule. F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (59 FR 22951, November 6, 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.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.” This rule does not have tribal implications. It 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, as specified in Executive Order 13175. This rule does not uniquely affect the communities of Indian Tribal Governments. Further, no circumstances specific to such communities exist that would cause an impact on these communities beyond those discussed in the other sections of this rule. This final rule merely changes the regulatory schedule for a rulemaking to address emissions from Category 3 marine engines. Thus, Executive Order 13175 does not apply to this rule. G. Executive Order 13045: Protection of Children from Environmental Health and Safety Risks Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that
(1)is determined to be “economically significant” as defined under Executive Order 12866, and
(2)concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, Section 5-501 of the Order directs the Agency to evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. This rule is not subject to the Executive Order because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This final rule merely changes the regulatory schedule for a rulemaking to address emissions from Category 3 marine diesel engines. H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use This rule is not a “significant energy action” as defined in Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. This final rule merely changes the regulatory schedule for a rulemaking to address emissions from Category 3 marine engines. I. National Technology Transfer and Advancement Act Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless doing so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (such as materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This final rule does not involve technical standards. This final rule merely changes the regulatory schedule for a rulemaking to address emissions from Category 3 marine engines. Therefore, EPA did not consider the use of any voluntary consensus standards. J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations Executive Order 12898 (59 FR 7629 (Feb. 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 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. This final rule merely changes the regulatory schedule for a rulemaking to address emissions from Category 3 marine diesel engines. K. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as amended 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 Congress and the Comptroller General of the United States. We 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 before 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). This final rule is effective on January 4, 2008. L. Statutory Authority The statutory authority for this action comes from section 213 of the Clean Air Act as amended (42 U.S.C. 7547). This action is a rulemaking subject to the provisions of Clean Air Act section 307(d). See 42 U.S.C. 7607(d). List of Subjects in 40 CFR Part 94 Environmental protection, Administrative practice and procedure, Air pollution control, Confidential business information, Imports, Penalties, Reporting and recordkeeping requirements, Vessels, Warranties. Dated: November 29, 2007. Stephen L. Johnson, Administrator. For the reasons set out in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as follows: PART 94—CONTROL OF AIR POLLUTION FROM MARINE COMPRESSION—IGNITION EMISSIONS 1. The authority citation for part 94 continues to read as follows: Authority: 42 U.S.C. 7401-7671q. 2. Section 94.8 is amended by revising paragraph (a)(2)(ii) to read as follows: § 94.8 Exhaust emission standards.
(a)* * *
(2)* * *
(ii)EPA has not finalized Tier 2 standards for Category 3 engines. EPA will promulgate final Tier 2 standards for Category 3 engines on or before December 17, 2009. [FR Doc. E7-23557 Filed 12-4-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 174 [EPA-HQ-OPP-2007-0574; FRL-8340-5] Bacillus Thuringiensis Vip3Aa20 Protein and the Genetic Material Necessary for its Production in Corn; Extension of Temporary Exemption From the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation extends the temporary exemption from the requirement of a tolerance for residues of *Bacillus thuringiensis* Vip3Aa20 protein in corn when applied or used as a plant-incorporated protectant. Syngenta Seeds, Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting that the temporary tolerance exemption be extended. This regulation eliminates the need to establish a maximum permissible level for residues of the *Bacillus thuringiensis* Vip3Aa20 protein in corn when applied or used as a plant-incorporated protectant on field corn, sweet corn, and popcorn. The temporary tolerance exemption expires on October 31, 2009. DATES: This regulation is effective December 5, 2007. Objections and requests for hearings must be received on or before February 4, 2008, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2007-0574. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., 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 in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Mike Mendelsohn, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)308-8715; e-mail address: *mendelsohn.mike@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this “ **Federal Register** ” document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 174 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, as amended by FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2007-0574 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before February 4, 2008. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2007-0574, by one of the following methods. • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of August 8, 2007 (72 FR 44521) (FRL-8139-7), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 7F7212) by Syngenta Seeds, Inc., 3054 Cornwallis Rd., P.O. Box 12257, Research Triangle Park, NC 27709. The petition requested that 40 CFR 174.458 (now 40 CFR 174.528, see the **Federal Register** issue of April 25, 2007 (72 FR 20431) (FRL-7742-2) be amended such that the temporary tolerance exemption for *Bacillus thuringiensis* Vip3Aa20 protein and the genetic material necessary for its production in corn when applied/used as a plant-incorporated protectant on field corn, sweet corn, and popcorn expires on October 31, 2009. This notice included a summary of the petition prepared by Syngenta Seeds, Inc., the registrant. There were no comments received in response to the notice of filing. Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe, ” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA, which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency consider “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. III. Toxicological Profile Consistent with section 408(c)(2)(B) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Data have been submitted demonstrating a lack of mammalian toxicity at high levels of exposure to the pure (microbially expressed) Vip3Aa20 protein. These data demonstrate the safety of Vip3Aa20 at well above maximum possible exposure levels that are reasonably anticipated in the crops. This is similar to the Agency position regarding toxicity and the requirement of residue data for the microbial *Bacillus thuringiensis* products from which this plant-incorporated protectant was derived (see 40 CFR 158.740(b)(2)(i)). For microbial products, the need for Tier II and III toxicity testing and residue data to verify the observed effects and clarify the source of these effects is triggered only by significant acute effects in studies such as the mouse oral toxicity study. In order to clarify the discussion that follows in the remainder of this final rule, it is necessary to distinguish the various Vip3A designations that are used. Vip3Aa20 is the designation applicable to Vip3A protein expressed in corn. Vip3Aa19 is the designation applicable to Vip3A protein expressed in cotton. Because the Agency has determined that both Vip3Aa19 and Vip3Aa20 are functionally equivalent, the Agency in amending this temporary tolerance exemption for Vip3Aa20 expressed in corn has relied on data and analysis specifically developed for Vip3Aa20, as well as on data and analysis specifically developed for Vip3Aa19. A separate temporary exemption from the requirement of tolerance already has been established for Vip3Aa19 as expressed in cotton (72 FR 40754; 40 CFR 174.501). An acute oral toxicity study was submitted for the Vip3Aa19 protein. Male and female mice (16 of each) were dosed with 3,675 milligrams/kilograms bodyweight (mg/kg bwt) of Vip3Aa19 protein. All mice survived the study, gained weight, had no test material-related clinical signs, and had no test material-related findings at necropsy. This acute oral toxicity data also supports the prediction that the Vip3Aa20 protein would be non-toxic to humans. When proteins are toxic, they are known to act via acute mechanisms and at very low-dose levels (Sjoblad, Roy D., et al. 1992). Therefore, since no effects were shown to be caused by the plant-incorporated protectants, even at relatively high-dose levels, the Vip3Aa20 protein is not considered toxic. Amino acid sequence comparisons showed no similarity between the Vip3Aa20 protein and known toxic proteins available in public protein data bases. According to the Codex Alimintarius guidelines, the assessment of potential toxicity also includes stability to heat Food and Agriculture Organization of the United Nations/World Health Organization Standards Programme, 2001. A heat lability study demonstrated that Vip3Aa19 is inactivated against fall army worm, when heated to 55 °C for 30 minutes. Since Vip3Aa20 is a protein, allergenic sensitivities were considered. Currently, no definitive tests exist for determining the allergenic potential of novel proteins. Therefore, EPA uses a weight of the evidence approach where the following factors are considered: source of the trait; amino acid sequence similarity with known allergens; prevalence in food; and biochemical properties of the protein, including *in vitro* digestibility in simulated gastric fluid, and glycosylation. Current scientific knowledge suggests that common food allergens tend to be resistant to degradation acid and proteases; may be glycosylated; and present at high concentrations in the food. Data have been submitted that demonstrate that the Vip3A from recombinant maize (LPPACHA-0199) and *E. coli* (VIP3A-0100) proteins are rapidly degraded by gastric fluid *in vitro* . (VIP3A-0100 refers to a microbially expressed Vip3A that has been shown to be the equivalent of the plant-expressed Vip3A protein.) In a solution of simulated gastric fluid (containing pepsin) and either 80 microLiter (µL) of LPPACHA-0199 or 320 µL of VIP3A-0100 test protein, both were shown to be susceptible to pepsin degradation. These data support the conclusion that Vip3A proteins expressed in transgenic plants will be readily digested as a conventional dietary protein under typical mammalian gastric conditions. Further data demonstrate that Vip3Aa20 is not glycoslylated and a comparison of amino acid sequences of known allergens uncovered no evidence of any homology with Vip3Aa20, even at the level of 8 contiguous amino acid residues. Preliminary data of the quantification of Vip3Aa20 protein in various maize tissues were also submitted. This data demonstrated that mean Vip3Aa20 concentrations in corn kernels ranged from circa ( *ca* ). 24.6-40.3 microgram (µg) Vip3Aa20/gram
(g)dry weight, representing *ca* . 0.003% of the total protein in grain (assuming that corn grain contains 10% total protein by weight). Therefore, Vip3Aa20 is present in low levels in corn tissue and the protein expression is much lower than the amounts of allergen protein found in commonly allergenic foods. In those foods, the allergens can be 10 to 50% of the total protein found. Therefore, the potential for the Vip3Aa20 protein to be a food allergen is minimal. As noted in grams/kilogram (gm/kg), toxic proteins typically act as acute toxins with low-dose levels. Therefore, since no effects were shown to be caused by this plant-incorporated protectant, even at relatively high-dose levels, the Vip3Aa20 protein is not considered toxic. IV. Aggregate Exposures In examining aggregate exposure, section 408 of FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). The Agency has considered available information on the aggregate exposure levels of consumers (and major identifiable subgroups of consumers) to the pesticide chemical residue and to other related substances. These considerations include dietary exposure under the tolerance exemption and all other tolerances or exemptions in effect for the plant-incorporated protectant chemical residue, and exposure from non-occupational sources. Exposure via the skin or inhalation is not likely since the plant-incorporated protectant is contained within plant cells, which essentially eliminates these exposure routes or reduces these exposure routes to negligible. The amino acid homology assessment revealed no similarities to known aeroallergens, indicating that Vip3A has a low potential to be an inhalation allergen. It has been demonstrated that there is no evidence of occupationally related respiratory symptoms, based on a health survey on migrant workers after exposure to *Bacillus thuringiensis* pesticides (Berstein et al. 1999), which provides further evidence of the negligible respiratory risks of *Bacillus thuringiensis* plant-incorporated protectants. Exposure via residential or lawn use to infants and children is also not expected because the use sites for the Vip3Aa20 protein are all agricultural for control of insects. Oral exposure, at very low levels may occur from ingestion of processed corn products and, theoretically, drinking water. However, oral toxicity testing done at a dose in excess of 3 grams/kilogram showed no adverse effects. Furthermore, the expected dietary exposure from both cotton and corn are several orders of magnitude lower than the amounts of Vip3Aa20 protein shown to have no toxicity. Therefore, even if negligible aggregate exposure should occur, the Agency concludes that such exposure would present no harm due to the lack of mammalian toxicity and the rapid digestibility demonstrated for the Vip3Aa20 proteins. V. Cumulative Effects Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered available information on the cumulative effects of such residues and other substances that have a common mechanism of toxicity. These considerations include the cumulative effects on infants and children of such residues and other substances with a common mechanism of toxicity. Because there is no indication of mammalian toxicity, the Agency concludes that there are no cumulative effects arising from Vip3Aa20 protein residues in corn. VI. Determination of Safety for U.S. Population, Infants and Children A. Toxicity and Allergenicity Conclusions The data submitted and cited regarding potential health effects for the Vip3Aa20 protein include the characterization of the expressed Vip3Aa20 protein in corn, as well as the acute oral toxicity, heat stability, and *in vitro* digestibility of the proteins. The results of these studies were determined applicable to evaluate human risk, and the validity, completeness, and reliability of the available data from the studies were considered. Adequate information was submitted to show that the Vip3A protein test material derived from microbial cultures (designated VIP3A-0100) was biochemically and functionally similar to the Vip3Aa20 protein expressed in corn. Microbially produced protein was chosen in order to obtain sufficient material for testing. The acute oral toxicity data submitted support the prediction that the Vip3Aa20 protein would be non-toxic to humans. As mentioned above, when proteins are toxic, they are known to act via acute mechanisms and at very low- dose levels (Sjoblad, Roy D., et al. 1992). Since no effects were shown to be caused by Vip3Aa20 protein, even at relatively high-dose levels (3,675 mg Vip3Aa19/kg bwt), the Vip3Aa20 protein is not considered toxic. This is similar to the Agency position regarding toxicity and the requirement of residue data for the microbial *Bacillus thuringiensis* products from which this plant-incorporated protectant was derived. Moreover, Vip3Aa20 showed no sequence similarity to any known toxin. Protein residue chemistry data for Vip3Aa20 were not required for a human health effects assessment of the subject plant-incorporated protectant ingredients because of the lack of mammalian toxicity. However, preliminary data (that were submitted with administrative materials for an Experimental Use Permit
(EUP)application for corn expressing the Vip3Aa20 protein) demonstrated low levels of Vip3Aa20 in corn tissues with less than 40 µg Vip3Aa20 protein/g dry weight in kernels and less than 75 μg Vip3Aa20 protein/g dry weight of whole corn plant. Since Vip3Aa20 is a protein, its potential allergenicity is also considered as part of the toxicity assessment. Information considered as part of the allergenicity assessment included data demonstrating that the Vip3Aa20 protein came from a *Bacillus thuringiensis* which is not a known allergenic source, showed no sequence similarity to known allergens, was readily degraded by pepsin, and was not glycosylated when expressed in the plant. Therefore, there is a reasonable certainty that the Vip3Aa20 protein will not be an allergen. Neither available information concerning the dietary consumption patterns of consumers (and major identifiable subgroups of consumers including infants and children), nor safety factors that are generally recognized as appropriate for the use of animal experimentation data were evaluated. The lack of mammalian toxicity at high levels of exposure to the Vip3Aa20 protein, as well as the minimal potential to be a food allergen, demonstrate the safety of Vip3Aa20 at levels well above possible maximum exposure levels anticipated in the crop. The genetic material necessary for the production of the plant-incorporated protectant active ingredients are the nucleic acids (DNA, RNA) which comprise genetic material encoding these proteins and their regulatory regions. The genetic material (DNA, RNA) necessary for the production of Vip3Aa20 protein already are exempted from the requirement of a tolerance under a blanket exemption for all nucleic acids (40 CFR 174.507). B. Infants and Children Risk Conclusions Section 408(b)(2)(C) of FFDCA provides that EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) also provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base, unless EPA determines that a different margin of safety will be safe for infants and children. In this instance, based on all the available information, the Agency concludes that there is a finding of no toxicity for the Vip3Aa20 protein and the genetic material necessary for its production in corn. Because there are no threshold effects of concern, the Agency has determined that the additional tenfold margin of safety is not necessary to protect infants and children. Further, the provisions of consumption patterns, special susceptibility, and cumulative effects do not apply. C. Overall Safety Conclusion There is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of the Vip3Aa20 protein and the genetic material necessary for its production in corn, when it is applied/used in accordance with good agricultural practices on field corn, sweet corn, and popcorn. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion because, as previously discussed, no toxicity to mammals has been observed, nor has there been any indication of allergenicity potential for this plant-incorporated protectant. VII. Other Considerations A. Endocrine Disruptors The pesticidal active ingredient is a protein, derived from sources that are not known to exert an influence on the endocrine system. Therefore, the Agency is not requiring information on the endocrine effects of the plant-incorporated protectant at this time. B. Analytical Method(s) A method for extraction and Enzyme Linked Immunosorbent (ELISA) Analysis of Vip3Aa20 protein in corn has been submitted and is under review by the Agency. C. Codex Maximum Residue Level No Codex maximum residue levels exist for the plant-incorporated protectant *Bacillus thuringiensis* Vip3Aa20 protein and the genetic material necessary for its production in corn. VIII. Statutory and Executive Order Reviews This final rule extends the exemption from the requirement of a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, 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) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq* .) do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). IX. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report 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 this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 174 Environmental protection, Administrative practice and procedure, Corn, Pesticides and pests, Reporting and recordkeeping requirements. Dated: November 19, 2007, Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 174—[AMENDED] 1. The authority citation for part 174 continues to read as follows: Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a and 371. 2. Section 174.528 is revised to read as follows: § 174.528 Bacillus thuringiensis Vip3Aa20 protein in corn; temporary exemption from the requirement of a tolerance. Residues of *Bacillus thuringiensis* Vip3Aa20 protein in corn are temporarily exempt from the requirement of a tolerance when used as a plant-incorporated protectant in the food and feed commodities; corn, field; corn, sweet; and corn, pop. This temporary exemption from the requirement of tolerance will permit the use of the food commodities in this section when treated in accordance with the provisions of the experimental use permit 67979-EUP-6, which is being amended and extended in accordance with the provisions of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136). This temporary exemption from the requirement of a tolerance expires and is revoked October 31, 2009; however, if the experimental use permit is revoked, or if any experience with or scientific data on this pesticide indicate that the temporary tolerance exemption is not safe, this temporary exemption from the requirement of a tolerance may be revoked at any time. [FR Doc. E7-23308 Filed 12-4-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2005-0195; FRL-8342-2] Ethalfluralin; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of ethalfluralin in or on dill, dried leaves; dill, fresh leaves; mustard, seed; potato; and rapeseed, seed. It also removes the current tolerance for residues of ethalfluralin on canola seed since residues on canola are covered by the rapeseed tolerance, thus making the canola tolerance unnecessary. Interregional Research Project Number 4 (IR-4) requested the new tolerances and removal of the canola tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective December 5, 2007. Objections and requests for hearings must be received on or before February 4, 2008, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION) . ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2005-0195. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., 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 in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305-5218; e-mail address: *stanton.susan@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2005-0195 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before February 4, 2008. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2005-0195, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. II. Petition for Tolerance In the **Federal Register** of August 31, 2005 (70 FR 51797) (FRL-7730-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petitions (PP 1E6326, PP 2E6360 and PP2E6466) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540-6635. The petitions requested that 40 CFR 180.416 be amended by establishing tolerances for residues of the herbicide ethalfluralin, [N-ethyl-N-(2-methyl-2-propenyl)-2,6-dinitro-4-(trifluoromethyl)benzenamine], in or on dill (PP 1E6326); rapeseed, canola, crambe and mustard seed (PP2E6466); and potato (PP 2E6360) at 0.05 parts per million (ppm). That notice included a summary of the petitions prepared by Dow AgroSciences LLC, the registrant, which is available to the public in the docket, *http://www.regulations.gov* . There were no comments received in response to the notice of filing. EPA has modified the tolerances proposed in PP 1E6326 (rapeseed, canola, crambe and mustard). The reason for these changes is explained in Unit V. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” These provisions were added to FFDCA by the Food Quality Protection Act
(FQPA)of 1996. Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerance for residues of ethalfluralin on dill, dried leaves; dill, fresh leaves; mustard, seed; potato; and rapeseed, seed at 0.05 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by ethalfluralin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *http://www.regulations.gov* in the document *Ethalfluralin: Human Health Risk Assessment for (IR-4) Proposed Uses on Dill and Potato* . The referenced document is available in the docket established by this action, which is described under ADDRESSES , and is identified as document number EPA-HQ-OPP-2005-0195-0001 in that docket. The toxicity database for ethalfluralin is complete and indicates it has low acute toxicity by oral, dermal, and inhalation routes of exposure. It is moderately irritating to the eye and produces moderate to severe skin irritation. In one study ethalfluralin was negative for dermal sensitization, but in another, it was considered positive. In general, subchronic and chronic feeding studies in rats, mice, and dogs indicate the liver as the target organ, with consistent effects of enzymatic changes, liver weight increases, and histopathology (chronic mouse). A combined chronic/carcinogenicity study in rats showed no non-neoplastic effects at the highest dose tested (32 milligrams/kilogram/day ((mg/kg/day). However, mammary gland fibroadenomas were increased in a dose-related manner. The mouse carcinogenicity study showed no increase in tumor incidence. Ethalfluralin was classified as a possible human carcinogen in 1994 and, pursuant to that classification, cancer risk is assessed using quantitative linear low-dose extrapolation. Ethalfluralin does not produce developmental toxicity in rats at doses up to 1,000 mg/kg/day. There are several rabbit developmental toxicity studies available; together, these studies indicate the potential for ethalfluralin to induce skeletal malformations at doses of >150 mg/kg/day. Maternal toxicity was observed at similar doses. Ethalfluralin did not produce reproductive or offspring effects in the 3-generation reproduction studies; the parental effects consisted of decreased body weight gains. There is no evidence of neurotoxicity in the submitted toxicity studies for ethalfluralin. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern
(LOC)is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors
(UFs)are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose
(aPAD)and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure
(MOE)called for by the product of all applicable UFs is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see *http://www.epa.gov/pesticides/factsheets/riskassess.htm* . A summary of the toxicological endpoints for ethalfluralin used for human risk assessment can be found at *http://www.regulations.gov* in document *Ethalfluralin: Human Health Risk Assessment for (IR-4) Proposed Uses on Dill and Potato* at pages 13-17 in docket ID number EPA-HQ-OPP-2005-0195. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to ethalfluralin, EPA considered exposure under the petitioned-for tolerances as well as all existing ethalfluralin tolerances in (40 CFR 180.416). EPA assessed dietary exposures from ethalfluralin in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effect was identified for the general population, including infants and children, in the toxicological studies for ethalfluralin. However, EPA identified potential acute effects (increased number of resorptions and increased sternal and cranial variations seen in the rabbit developmental toxicity study) for the population subgroup females, 13 to 49 years old. In estimating acute dietary exposure of females, 13 to 49 years old, EPA used food consumption information from the U.S. Department of Agriculture
(USDA)1994-1996 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA relied on anticipated residues derived from field trial data for certain commodities (dry bean, peanuts, dry peas, soybeans and sunflower seed) and assumed tolerance level residues for the remaining commodities, including dill and potato. EPA assumed 100 percent crop treated
(PCT)for all commodities. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the 1994-1996 and 1998 CSFII. As to residues in food, EPA relied on the same anticipated residues and tolerances as in the acute exposure assessment and assumed 100 PCT for all commodities. iii. *Cancer* . EPA has classified ethalfluralin as a possible human carcinogen, based on a dose-related increase in mammary gland fibroadenomas observed in the rat carcinogenicity study. EPA evaluated cancer risk using a quantitative approach based on a cancer potency factor, or Q1*, of 8.9 x 10 -2 (mg/kg/day) -1 . As to residues in food, EPA relied on the same estimates used in the acute and chronic exposure assessments for all commodities except soybean, watermelon and potato. For soybean and watermelon, EPA relied on anticipated residues derived from the USDA Pesticide Data Program monitoring data. The anticipated residue for potatoes was derived from field trial data. EPA assumed 100 PCT for all commodities. iv. *Anticipated residue and PCT information* . Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must pursuant tosection 408(f)(1) of FFDCA require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by section 408(b)(2)(E) of FFDCA and authorized under section 408(f)(1) of FFDCA. Data will be required to be submitted no later than 5 years from the date of issuance of this tolerance. EPA did not use any information on the actual percent of crops treated with ethalfluralin, but rather assumed 100% of each crop would be treated and contain residues of ethalfluralin. 2. *Dietary exposure from drinking water* . Drinking water monitoring data collected by USDA's Pesticide Data Program
(PDP)are available for ethalfluralin for the years 2003, 2004 and 2005. During this time period, a total of 1,253 water samples were collected and found to contain no detectable residues of ethalfluralin. The limit of detection
(LOD)of the method used to collect the data was 45.4 parts per trillion (ppt). EPA used a value equal to ½ the LOD or 22.7 ppt (0.023 parts per billion (ppb)) to assess cancer risk from residues of ethalfluralin in drinking water. The PDP drinking water monitoring data were considered to be appropriate to assess cancer risk from the established and new uses of ethalfluralin for the following reasons: i. Application rates for both existing and new uses are similar; while peak drinking water estimates differ slightly from one crop to another, the Agency's modeled drinking water numbers for the average of yearly means did not differ significantly by crop, supporting the notion that the existing monitoring data can support new uses; ii. The drinking water monitoring data were collected over multiple years from a variety of states which include potential ethalfluralin use areas; iii. The lack of findings of detectable residues is supported by modeled drinking water estimates and by the environmental fate properties of ethalfluralin (e.g., 6-hour half-life for aqueous photolysis). EPA did not use the PDP data to evaluate acute or chronic risk from residues of ethalfluralin in drinking water. PDP drinking water monitoring data are not appropriate for use in acute dietary exposure assessments, because the frequency of sample collection may not accurately capture peak drinking water values. However, for the purpose of chronic and cancer assessments, multiple years of data over multiple seasons and reflecting a variety of sampling regions are considered to provide an additional level of refinement over the use of modeled drinking water estimates. In the case of ethalfluralin, since estimated chronic risks based on more conservative modeled estimates are below the Agency's LOC, the additional refinement provided by the PDP data is not necessary. Therefore, for both the acute and chronic dietary exposure assessments EPA relied on estimates of ethalfluralin residues in drinking water developed through simulation or modeling taking into account data on the environmental fate characteristics of ethalfluralin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm* . Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated environmental concentrations
(EECs)of ethalfluralin for acute exposures are estimated to be 11 ppb for surface water and 0.02 ppb for ground water. The EECs for chronic exposures are estimated to be 0.4 ppb for surface water and 0.02 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 11 ppb was used to access the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 0.4 ppb was used to access the contribution to drinking water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Ethalfluralin is not registered for use on any sites that would result in residential exposure. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to ethalfluralin and any other substances and ethalfluralin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that ethalfluralin has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional (“10X”) tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional UFs and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . The prenatal and postnatal toxicology database for ethalfluralin includes a rat developmental toxicity study, several rabbit developmental toxicity studies and a 3-generation reproduction toxicity study in rats. There was no quantitative or qualitative evidence of increased prenatal or postnatal sensitivity in the rat developmental toxicity study or 3-generation reproduction toxicity study in rats. The rabbit developmental toxicity studies indicate the potential for ethalfluralin to induce skeletal malformations at doses of ≥ 150 mg/kg/day. These effects were seen in the presence of maternal toxicity. Although there is evidence of increased qualitative susceptibility in young in the developmental toxicity studies in rabbits, there are no residual uncertainties and the degree of concern is low. The developmental effects seen at the LOAEL of 150 mg/kg/day are slight (mainly sternal variations in one or two fetuses, incomplete cranial development in 2 fetuses and a slight increase in resorptions). There is a clear NOAEL for these effects and the effects occurred in the presence of maternal toxicity. Additionally, the dose used for risk assessment purposes is 75 mg/kg/day, the NOAEL from the developmental studies in rabbits. Use of this NOAEL for risk assessment is protective of any potential developmental effects. 3. *Conclusion* . EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: i. The toxicity database for ethalfluralin is complete. ii. There is no indication that ethalfluralin is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. Although there is qualitative evidence of increased susceptibility in the prenatal developmental studies in rabbits, the risk assessment team did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of ethalfluralin. The degree of concern for prenatal and/or postnatal toxicity is low. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level or anticipated residues derived using reliable field trial data. Conservative ground and surface water modeling estimates were used to assess threshold acute and chronic risks. These assessments will not underestimate the exposure and risks posed by ethalfluralin. E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to ethalfluralin will occupy less than 1% of the aPAD for females 13 to 49 years old, the population group of concern for acute exposure to ethalfluralin. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to ethalfluralin from food and water will utilize less than 1% of the cPAD for children, 1 to 2 years old, the population group with the greatest estimated exposure. There are no residential uses for ethalfluralin that result in chronic residential exposure to ethalfluralin. 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Ethalfluralin is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Ethalfluralin is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's LOC. 5. *Aggregate cancer risk for U.S. population* . Using the exposure assumptions described in this unit for the cancer risk assessment, EPA has concluded that exposure to ethalfluralin from food and water will result in a lifetime cancer risk of 2 x 10 -6 for the U.S. population. This risk estimate is based, in part, on the conservative assumption that 100% of all crops for which ethalfluralin is registered or proposed for registration are treated. Additional refinement using PCT estimates would result in a lower estimate of dietary cancer risk. EPA generally considers cancer risks in the range of 10 -6 or less to be negligible. The precision which can be assumed for cancer risk estimates is best described by rounding to the nearest integral order of magnitude on the log scale; for example, risks falling between 3.16 x 10 -7 and 3.16 x 10 -6 are expressed as risks in the range of 10 -6 . Considering the precision with which cancer hazard can be estimated, the conservativeness of low-dose linear extrapolation, and the rounding procedure described above, cancer risk should generally not be assumed to exceed the benchmark LOC of the range of 10 -6 until the calculated risk exceeds approximately 3 x 10 -6 . Since the calculated cancer risk for ethalfluralin falls below this level, estimated cancer risk is considered to be negligible. 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to ethalfluralin residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology is available to enforce the tolerance expression. Two gas chromatograph
(GC)methods, Methods I and II, both with electron capture detection
(ECD)are listed in the Pesticide Analytical Manual (PAM, Vol. II, section 180.416). Methods I and II are applicable for the analysis of ethalfluralin residues in/on plant and animal commodities, respectively. The limits of detection
(LODs)are 0.01 and <0.01 ppm for methods I and II, respectively. B. International Residue Limits There are currently no Codex, Canadian, or Mexican Maximum Residue Limits
(MRLs)established on the commodities associated with these petitions. V. Conclusion EPA has determined that the proposed tolerance on crambe is unnecessary, since, pursuant to 40 CFR 180.1(g), the tolerance being established for rapeseed also applies to residues of ethalfluralin on crambe. The rapeseed tolerance also covers residues of ethalfluralin in or on canola seed. Since there is no longer a need for the canola tolerance, EPA is removing this tolerance as requested in IR-4's petition. Therefore, tolerances are established for residues of ethalfluralin, N-ethyl-N-(2-methyl-2-propenyl)-2,6-dinitro-4-(trifluoromethyl)benzenamine, in or on dill, dried leaves; dill, fresh leaves; mustard, seed; potato; and rapeseed, seed at 0.05 ppm. The current tolerance of 0.05 ppm on canola is removed. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, 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) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq* .) do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report 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 this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: November 26, 2007. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.416 is amended by removing the current tolerance on “Canola, seed” and alphabetically adding the following commodities to the table in paragraph
(a)to read as follows: §180.416 Ethalfluralin; tolerances for residues.
(a)* * * Commodity Parts per million * * * * * Dill, dried leaves 0.05 Dill, fresh leaves 0.05 Mustard, seed 0.05 * * * * * Potato 0.05 Rapeseed, seed 0.05 * * * * * [FR Doc. E7-23578 Filed 12-4-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0310; FRL-8339-8] Spinosad; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of spinosad in or on spice, subgroup 19B, except black pepper; pineapple; and pineapple, process residue. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective December 5, 2007. Objections and requests for hearings must be received on or before February 4, 2008, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION) . ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2007-0310. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., 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 in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305-5218; e-mail address: *stanton.susan@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2007-0310 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before January 4, 2008. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2007-0310, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. II. Petition for Tolerance In the **Federal Register** of May 9, 2007 (72 FR 26375) (FRL-8128-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6E7148) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540-6635. The petition requested that 40 CFR 180.495 be amended by establishing a tolerance for residues of the insecticide spinosad, in or on Spice crop subgroup 19B, except black pepper at 1.7 parts per million (ppm); pineapple at 0.02 ppm; and pineapple, process residue at 0.08 ppm. Spinosad is a fermentation product of *Saccharopolyspora spinosa* , consisting of two related active ingredients: Spinosyn A (Factor A; CAS # 131929-60-7) or 2-[(6-deoxy-2,3,4-tri- *O* -methyl-α- *L* -manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D; CAS # 131929-63-0) or 2-[(6-deoxy-2,3,4-tri- *O* -methyl-α- *L* -manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione. That notice referenced a summary of the petition prepared by Dow AgroSciences LLC, the registrant, which is available to the public in the docket, *http://www.regulations.gov* . Comments were received on the notice of filing from a private citizen. EPA's response to these comments is discussed in Unit IV.C. below. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” These provisions were added to FFDCA by the Food Quality Protection Act
(FQPA)of 1996. Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for residues of spinosad on spice, subgroup 19B, except black pepper at 1.7 ppm; pineapple at 0.02 ppm; and Pineapple, process residue at 0.08 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by spinosad as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rule published in the **Federal Register** of September 27, 2002 (67 FR 60923) (FRL-7199-5), available on-line at *http://www.epa.gov/fedrgstr/EPA-PEST/2002/September/Day-27/p24484.htm* . B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern
(LOC)is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors
(UFs)are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose
(aPAD)and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure
(MOE)called for by the product of all applicable UFs is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see *http://www.epa.gov/pesticides/factsheets/riskassess.htm* . The Agency has concluded that spinosad should be considered toxicologically identical to another pesticide, spinetoram. This conclusion is based on the following:
(1)Spinetoram and spinosad are large molecules with nearly identical structures; and
(2)the toxicological profiles for each are similar (generalized systemic toxicity) with similar doses and endpoints chosen for human-health risk assessment. Spinosad and spinetoram should be considered toxicologically identical in the same manner that metabolites are generally considered toxicologically identical to the parent. Although, as stated above, the doses and endpoints for spinosad and spinetoram are similar, they are not identical due to variations in dosing levels used in the spinetoram and spinosad toxicological studies. EPA compared the spinosad and spinetoram doses and endpoints for each exposure scenario and selected the lower of the two doses for use in human risk assessment. A summary of the toxicological endpoints for spinosad and spinetoram used for human risk assessment can be found at *http://www.regulations.gov* in the document *Spinosad and Spinetoram. Human-Health Risk Assessment for Application of Spinosad to Pineapple and the Spice Subgroup (19B, except black pepper)* at page 11 in docket ID number EPA-HQ-OPP-2007-0310. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to spinosad, EPA considered exposure under the petitioned-for tolerances as well as all existing spinosad tolerances in 40 CFR 180.495. Since spinosad and spinetoram are toxicologically identical, EPA considered exposure to both in assessing aggregate risk. EPA assessed dietary exposures from spinosad and spinetoram in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for spinosad and spinetoram; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. *Chronic exposure* . Spinosad and spinetoram are registered for use on the same crops; however, EPA has concluded it would overstate exposure to assume that residues of both spinosad and spinetoram would appear on the same crop. It is unlikely that both will be applied to the same crop, since spinosad and spinetoram control the same pest species. Rather, EPA aggregated exposure from residues of spinosad and spinetoram by assuming that spinosad residues would be present in all commodities, because side-by-side spinosad and spinetoram residue data indicated that spinetoram residues were less than or equal to spinosad residues. EPA assumed that 100 percent of each food crop commodity would be treated with spinosad. For feed crop commodities, EPA summed the percentage of the crop that would be treated with spinosad and the percentage expected to be treated with spinetoram and used this estimate in conjunction with spinosad residue data to develop anticipated residues for livestock commodities. The chronic dietary exposure assessment was conducted using the Dietary Exposure Evaluation Model - Food Consumption Intake Database (DEEM TM -FCID), Version 2.03, which incorporates food consumption data from the United States Department of Agriculture
(USDA)1994-1996 and 1998 Continuing Surveys of Food Intakes by Individuals (CSFII). In addition to the Percent Crop Treated
(PCT)assumptions described above, EPA, in estimating chronic exposure, relied upon average field trial residues for apple, leafy vegetables (except Brassica), citrus and fruiting vegetables; tolerance level residues for the remaining food crop commodities; average feed crop residues for feed commodities from the following crops: Sweet corn forage, leaves of root and tuber vegetables and aspirated grain fractions; average residues from animal feeding and dermal magnitude of residue studies; and DEEM TM (Version 7.81) default processing factors for all commodities, excluding field corn (meal, starch, flour and oil), grape juice and wheat (flour and germ), where processing factors based on the results of processing studies were assumed. iii. *Cancer* . Based on the results of carcinogenicity studies in rats and mice, spinosad has been classified as “Not likely to be carcinogenic to humans.” Preliminary results of a carcinogenicity study in mice indicate that spinetoram is not carcinogenic to mice at doses up to 37.5 milligram/kilogram/day (mg/kg/day). Based on these preliminary results and spinetoram's structural and toxicological similarity to spinosad, spinetoram is also considered to be “Not likely to be carcinogenic to humans.” Consequently, a quantitative cancer exposure and risk assessment is not appropriate for spinosad or spinetoram. iv. *Anticipated residue and PCT information* . Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must pursuant to FFDCA section 408(f)(1) require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of this tolerance. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if: a. The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue. b. The exposure estimate does not underestimate exposure for any significant subpopulation group. c. Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT. The Agency used PCT information as follows: One-hundred percent crop treated was assumed for all food crop commodities and some feed crop commodities (aspirated grain fractions, sugarbeet molasses and cottonseed). For certain feed crop commodities, the Agency summed the projected PCT for spinosad and spinetoram and used the combined estimates in conjunction with average field trial residues to calculate cattle dietary burdens and anticipated residues of spinosad in meat and milk. The following combined projected PCT estimates were used: sweet corn forage (39%), sorghum grain (5%), soybean seed meal (5%) and leaves of root and tuber vegetables (50%). Spinetoram is a new, recently registered pesticide. EPA estimates an upper bound of projected percent crop treated
(PPCT)for a new pesticide use by assuming that its actual PCT during the initial 5 years of use on a specific use site will not exceed the recent PCT of the market leader (i.e., the one with the greatest PCT) on that site. EPA calls this the market leader PPCT estimate. In this specific case, the new use to be estimated is the combined use of spinosad together with that of spinetoram since the most new use of spinetoram will likely replace previous use of spinosad. An average market leader PCT, based on three recent surveys of pesticide usage, if available, is used for chronic risk assessment. The average market leader PCT may be based on one or two survey years if three are not available. Also, with limited availability of data, the average market leader PCT may be based on a cross-section of state PCTs. Comparisons are only made among pesticides of the same pesticide type (i.e., the leading insecticide on the use site is selected for comparison with the new insecticide), or, for refined estimates, among pesticides targeting the same pests. The market leader PCTs used to determine the average may be each for the same pesticide or for different pesticides for any year since the same or different pesticides may dominate for each year. Typically, EPA uses U.S. Department of Agriculture/National Agricultural Statistics Service (USDA/NASS) as the source for raw PCT data because it is publicly available. When a specific use site is not surveyed by USDA/NASS, EPA uses other sources including proprietary data. An estimated PPCT, based on the average PCT of the market leaders, is appropriate for use in chronic dietary risk assessment. This method of estimating PPCT for a new use of a registered pesticide or a new pesticide produces a high-end estimate that is unlikely, in most cases, to be exceeded during the initial 5 years of actual use. Predominant factors that bear on whether the PPCT could be exceeded may include PCTs of similar chemistries, pests controlled by alternatives, pest prevalence in the market and other factors. All relevant information currently available for predominant factors has been considered for the combined use of spinetoram and spinosad on each of these several crops. It is the Agency's opinion that it is unlikely that actual combined PCTs for spinetoram and spinosad will exceed the corresponding estimated PPCTs during the next 5 years. The PPCTs for the combined use of spinosad and spinetoram for chronic risk assessment were determined using the market leader approach for the feed commodities of sweet corn, grain sorghum, soybeans and turnip greens. For turnip greens, the PCTs of market leaders were averaged over states rather than years because only 1-year of data was available. The Agency believes that the three conditions listed in this Unit have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which spinosad may be applied in a particular area. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for spinosad in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of spinosad. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm* . Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated environmental concentrations
(EECs)of spinosad for acute exposures are estimated to be 34.5 parts per billion
(ppb)for surface water and 1.1 ppb for ground water. The EECs for chronic exposures are estimated to be 10.5 ppb for surface water and 1.1 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. As explained above, an acute dietary risk assessment was not conducted for spinosad and spinetoram. For chronic dietary risk assessment, the water concentration of value 10.5 ppb was used to access the contribution to drinking water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). The Agency has concluded that spinosad and spinetoram are toxicologically equivalent; therefore, residential exposure to both spinosad and spinetoram was evaluated. Spinosad is currently registered for the following residential non-dietary sites: Homeowner application to turf grass and ornamentals to control a variety of worms, moths, flies, beetles, midges, thrips, leafminers and fire ants (granular formulation). Spinetoram is registered for homeowner applications to gardens, lawns/ornamentals and turf grass for control of lepidopterous larvae (worms or caterpillars), dipterous leafminers, thrips, sawfly larvae, certain psyllids and leaf-feeding beetles and red imported fire ants. There is potential for residential handler and post-application exposures to both spinosad and spinetoram. Since spinosad and spinetoram control the same pests, EPA concludes that these products will not be used in combination with each other and combining the residential exposures is unnecessary. Short-term residential inhalation risks were estimated for adult residential handlers, as well as short-term post-application incidental oral risks for toddlers, based on applications to home lawns, home gardens and ornamentals. Dermal exposures were not assessed, since no dermal endpoints of concern were identified in the toxicology studies for spinosad and spinetoram. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to spinosad and any other substances and spinosad does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that spinosad has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional (“10X”) tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional UFs and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . The following acceptable studies are available for both spinosad and spinoteram: developmental toxicity studies in rats and rabbits and a two-generation reproduction study in rats. There is no evidence of increased susceptibility of rat or rabbit fetuses to *in utero* exposure to spinosad or spinetoram. In the spinosad and spinetoram rat and rabbit developmental toxicity studies, no developmental toxicity was observed at dose levels that induced maternal toxicity. In the spinosad two-generation reproduction study, maternal and offspring toxicity were equally severe, indicating no evidence of increased susceptibility. In the spinetoram 2-generation reproduction study, no adverse effects were observed in the offspring at dose levels that produced parental toxicity. Therefore, there is no evidence of increased susceptibility and there are no concerns or residual uncertainties for pre and/or post-natal toxicity. 3. *Conclusion* . EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: i. The toxicity database for spinosad is complete. The toxicity database for spinetoram is adequate for this risk assessment despite the lack of a chronic toxicity study in rats. The preliminary review of a mouse carcinogenicity study for spinetoram provides evidence that the chronic toxicity of spinosad and spinetoram are comparable, since spinetoram produced similar toxicity at doses similar to those seen previously with spinosad. Therefore, it is expected that the ongoing spinetoram chronic carcinogenicity study in rats would produce similar chronic toxicity at a similar dose as was seen in the chronic toxicity study in rats with spinosad. ii. There is no indication that spinosad or spinetoram are neurotoxic chemicals and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that spinosad or spinetoram results in increased susceptibility in *in utero* rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction studies. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on tolerance-level residues or anticipated residues derived from reliable field trial data. 100 PCT was assumed for all commodities except certain feed crop commodities. The projected PCT estimates used for these commodities are conservative, high-end estimates developed using the market leader approach that are unlikely to be exceeded. Conservative ground and surface water modeling estimates were used. Similarly, conservative Residential SOPs were used to assess incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by spinosad and spinetoram. E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. *Acute risk* . None of the toxicology studies available for spinosad or spinetoram has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure; therefore, spinosad and spinetoram are not expected to pose an acute risk. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to spinosad and spinetoram from food and water will utilize 81% of the cPAD for children, 1 to 2 years old, the population group with the greatest estimated exposure. Based on the use patterns, chronic residential exposure to residues of spinosad or spinetoram is not expected. 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Spinosad and spinetoram are currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for spinosad and spinetoram. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food, water, and residential exposures aggregated result in aggregate MOEs of 650 to 710 for adults and 180 to 300 for infants and children. The aggregate MOEs for adults are based on the residential turf scenario and include combined food, drinking water and handler inhalation exposures to spinetoram. Inhalation exposures are not expected for residential handlers of spinosad, based on its granular formulation and low vapor pressure. The aggregate MOEs for infants and children include food, drinking water and incidental oral exposures on turf areas previously treated with spinosad or spinetoram. Dermal exposures were not assessed for adults or children, since a dermal endpoint of concern was not identified in the toxicology studies for spinosad or spinetoram. 4. *Intermediate-term risk.* Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Spinosad is not registered for use on any sites that would result in intermediate-term (1-6 months) residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which does not exceed the Agency's level of concern. 5. *Aggregate cancer risk for U.S. population* . Based on the results of carcinogenicity studies with spinosad in rats and mice and the preliminary results of a carcinogenicity study with spinetoram in mice, spinosad and spinetoram are considered “Not likely to be carcinogenic to humans.” Spinosad and spinetoram are not expected to pose a cancer risk. 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to spinosad and spinetoram residues. IV. Other Considerations A. Analytical Enforcement Methodology DowElanco Method 97.05, an immunoassay particle-based method, and Dow AgroSciences Method GRM 03.15, a high performance liquid chromatography method with ultraviolet absorption detection (HPLC/UV), have been adequately validated and determined to be acceptable to enforce the tolerance expression in spices and pineapple, respectively. The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:
(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits There are currently no established Codex, Canadian, or Mexican maximum residue levels
(MRLs)for spinosad (i.e., the combined residues of spinosyn A and D). C. Response to Comments Several comments were received from a private citizen, B. Sachau, objecting to establishing these tolerances for a variety of generalized and unsubstantiated reasons, including the lack of “combinant” testing and long-term testing, pesticide residues and unacceptable risk to Americans. The Agency has received these same or similar comments from this commenter on numerous previous occasions. Refer to **Federal Registers** of June 30, 2005 (70 FR 37683) (FRL-7718-3), January 7, 2005 (70 FR 1349) (FRL-7691-4), and October 29, 2004 (69 FR 63083) (FRL-7681-9) for the Agency's response to these objections. The commenter also objected to issuance of “exemptions” for this pesticide, an irrelevant comment in the context of this tolerance-setting action. Finally, this same commenter raised concerns about risk to insects and other animals from spinosad. EPA considers such environmental risks in deciding whether to register pesticide products under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA); however, the safety standard for approving tolerances under section 408 of the FFDCA focuses on potential harms to human health and does not permit consideration of effects on the environment. Therefore, the comment regarding risk to insects and other animals is not relevant to this tolerance action. V. Conclusion Therefore, tolerances are established for residues of spinosad, consisting of two related active ingredients: Spinosyn A (Factor A; CAS # 131929-60-7) or 2-[(6-deoxy-2,3,4-tri- *O* -methyl-α- *L* -manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D; CAS # 131929-63-0) or 2-[(6-deoxy-2,3,4-tri- *O* -methyl-α- *L* -manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on Spice, subgroup 19B, except black pepper at 1.7 ppm; Pineapple at 0.02 ppm; and Pineapple, process residue at 0.08 ppm. The table of spinosad tolerances at 40 CFR 180.495(a) currently includes a third column for expiration/revocation dates. Since none of the existing tolerances are time-limited and EPA is not time-limiting the new tolerances for spice and pineapple commodities, there is no need for this column. Therefore, the third column of the table is being deleted. Time-limited tolerances were established at 40 CFR 180.495(b) for residues of spinosad in or on livestock commodities in connection with FIFRA section 18 emergency exemptions granted by EPA. All of these time-limited tolerances have expired and are no longer necessary, because permanent tolerances have been established on these commodities at higher levels. Therefore, these expired, time-limited tolerances for residues of spinosad (Factor A and Factor D) are revoked. Finally, EPA is correcting the commodity terminology for “Vegetable, brassica, leafy, group 5” in 40 CFR 180.495(a) to read “Brassica, leafy greens, subgroup 5B” at 10.0 ppm, to undo a transcription error. In 1998, EPA established spinosad tolerances for the two subgroups in Crop Group 5 - Brassica
(Cole)Leafy Vegetables (40 CFR 180.41(c)(5). (63 FR 18329, April 15, 1998). The two subgroups in Group 5 are Crop Subgroup 5A - Head and Stem Brassica and Crop Subgroup 5B - Leafy Brassica Greens. Tolerances were established for the subgroups at levels of 2 ppm and 10 ppm respectively. No tolerance applying across the whole brassica crop group was established. Subsequently, in a rulemaking establishing spinosad tolerances for various non-brassica commodities the tolerance for the “greens” subgroup was incorrectly transcribed as a tolerance for the entire brassica group (70 FR 1349, January 7, 2005). This transcription error occurred when the tolerance table, as revised by the addition of the new non-brassica tolerances, was printed in the **Federal Register** . The changing of the subgroup tolerance to a group tolerance was clearly nothing more than a transcription error, because it was not mentioned in the notice of filing for the rulemaking or the preamble to the final rule. Moreover, it is inconsistent with the generic crop group regulation to establish both a crop group and subgroup of that crop group for the same pesticide because the former would displace the latter. This change merely corrects the tolerance regulation to specify the crop subgroup tolerance that was actually promulgated, since this tolerance is intended to cover only those commodities in the “greens” subgroup. A separate, lower tolerance of 2.0 ppm has been established to cover head and stem Brassica in subgroup 5A. The tolerance for the “greens” subgroup was incorrectly modified in connection with the establishment of new spinosad tolerances in the **Federal Register** of January 7, 2005 (70 FR 1349). EPA finds there is good cause to make these latter three changes without prior notice and comment because they are technical corrections which either eliminate obsolete or unused portions of the regulation or correct a transcription error. EPA concludes notice and comment are unnecessary on such changes. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, 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) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq* .) do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report 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 this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: November 27, 2007. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.495 is revised to read as follows: § 180.495 Spinosad; tolerances for residues.
(a)*General* . Tolerances are established for residues of the insecticide spinosad in or on the food commodities in the table to this paragraph. Spinosad is a fermentation product of *Saccharopolyspora spinosa* . The product consists of two related active ingredients: Spinosyn A (Factor A: CAS # 131929-60-7) or 2-[(6-deoxy-2,3,4-tri- *O* -methyl-α- *L* -manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D; CAS # 131929-63-0) or 2-[(6-deoxy-2,3,4-tri- *O* -methyl-α- *L* -manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione. Commodity Parts per million Acerola 1.5 Alfalfa, seed 0.15 Alfalfa, seed screenings 2.0 Almond, hulls 2.0 Amaranth, grain, grain 1.0 Amaranth, grain, stover 10 Animal feed, nongrass, group, 18 0.02 Animal feed, nongrass, group, 18, forage 35.0 Animal feed, nongrass, group, 18, hay 30.0 Apple pomace 0.5 Artichoke, globe 0.3 Asparagus 0.2 Atemoya 0.3 Avocado 0.3 Banana 0.25 Beet, sugar, molasses 0.75 Biriba 0.3 Brassica, head and stem, subgroup 5A 2.0 Brassica, leafy greens, subgroup 5B 10.0 Bushberry subgroup 13B 0.250 Caneberry subgroup 13A 0.7 Canistel 0.3 Cattle, fat 50 Cattle, liver 10 Cattle, meat 2.0 Cattle, meat byproducts, except liver 5.0 Cherimoya 0.3 Citrus, oil 3.0 Citrus, dried pulp 0.5 Coriander, leaves 8.0 Corn, sweet, kernel plus cob with husks removed 0.02 Cotton, gin byproducts 1.5 Cotton, undelinted seed 0.02 Cranberry 0.01 Custard apple 0.3 Egg 0.30 Feijoa .05 Fig 0.10 Fish 4.0 Fish-shellfish, crustacean 4.0 Fish-shellfish, mollusc 4.0 Food commodities 0.02 Fruit, citrus, group 10 0.3 Fruit, pome, group 11 0.20 Fruit, stone, group 12 0.20 Goat, fat 50 Goat, liver 10 Goat, meat 2.0 Goat, meat byproducts, except liver 5.0 Grain, aspirated fractions 200 Grain, cereal, group 15 1.5 Grain, cereal, group 16, forage, except rice 2.5 Grain, cereal, group 16, hay, except rice 10.0 Grain, cereal, group, 16, stover, except rice 10.0 Grain, cereal, group, 16, straw, except rice 1.0 Grape 0.50 Grape, raisin 0.70 Grass, forage, fodder and hay, group 17, forage 10.0 Grass, forage, fodder and hay, group 17, hay 5.0 Guava 0.3 Herb subgroup 19A, dried 22 Herb subgroup 19A, fresh 3.0 Hog, fat 33 Hog, meat byproducts 8.0 Hog, meat 1.5 Hop, dried cones 22 Horse, fat 50 Horse, liver 10 Horse, meat 2.0 Horse, meat byproducts, except liver 5.0 Ilama 0.3 Jaboticaba 0.3 Juneberry 0.25 Lingonberry 0.250 Longan 0.3 Lychee 0.3 Mango 0.3 Milk 7.0 Milk, fat 85 Nut, tree, group 14 0.02 Okra 0.40 Onion, green 2.0 Papaya 0.3 Passionfruit 0.3 Pea and bean, dried shelled, except soybean, subgroup 6C 0.02 Pea and bean, succulent shelled, subgroup 6B 0.02 Peanut 0.02 Peanut, hay 11.0 Peppermint, tops 3.5 Pineapple 0.02 Pineapple, process residue 0.08 Pistachio 0.020 Poultry, fat 1.3 Poultry, meat 0.10 Poultry, meat byproducts 0.10 Pulasan 0.3 Rambutan 0.3 Rice, hulls 4.0 Salal 0.250 Sapodilla 0.3 Sapote, black 0.3 Sapote, mamey 0.3 Sapote, white 0.3 Sheep, fat 50 Sheep, liver 10 Sheep, meat 2.0 Sheep, meat byproducts, except liver 5.0 Soursop 0.3 Soybean 0.02 Spanish lime 0.3 Spearmint, tops 3.5 Spice, subgroup 19B, except black pepper 1.7 Star apple 0.3 Starfruit 0.3 Strawberry 1.0 Sugar apple 0.3 Ti, leaves 10.0 Vegetable, bulb, group 3, except green onion 0.10 Vegetable, cucurbit, group 9 0.3 Vegetable, foliage of legume, group 7 8.0 Vegetable, fruiting, group 8 0.4 Vegetable, leafy, except brassica, group 4 8.0 Vegetable, leaves of root and tuber, group 2 10.0 Vegetable, legume, edible podded, subgroup 6A 0.30 Vegetable, root and tuber, group 1 0.10 Watercress 8.0 Wax jambu 0.3
(b)*Section 18 emergency exemptions* . [Reserved]
(c)*Tolerances with regional registrations* . [Reserved]
(d)*Indirect or inadvertant residues* . [Reserved] [FR Doc. E7-23579 Filed 12-4-07; 8:45 am] BILLING CODE 6560-50-S 72 233 Wednesday, December 5, 2007 Proposed Rules DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 51 [Docket # AMS-FV-07-0010; FV-06-302] United States Standards for Grades of Sweet Cherries AGENCY: Agricultural Marketing Service, USDA. ACTION: Advanced notice of proposed rulemaking; withdrawal. SUMMARY: The Agricultural Marketing Service
(AMS)is withdrawing the notice soliciting comments on its proposal to amend the voluntary United States Standards for Grades of Sweet Cherries. After reviewing and considering the comments received, the agency has decided not to proceed with this action. EFFECTIVE DATE: December 5, 2007. FOR FURTHER INFORMATION CONTACT: Vincent J. Fusaro, Standardization Section, Fresh Products Branch,
(202)720-2185. The United States Standards for Grades of Sweet Cherries are available by accessing the Fresh Products Branch Web site at: *http://www.ams.usda.gov/standards/stanfrfv.htm.* Background AMS identified the United States Standards for Grades of Sweet Cherries for possible revisions. The revision would have included adding standardized row sizes into the standard. These standardized row sizes would establish a uniform basis for defining size in the industry. The standards were last revised on May 7, 1971. On March 30, 2007, AMS published a proposed rule in the **Federal Register** (72 FR 15055) soliciting comments on a possible revision to the United States Standards for Grades of Sweet Cherries. The sixty-day comment period ended May 29, 2007. Three comments were received. All three comments received, one from a grower, packer, shipper, another from a separate grower, packer, shipper, and one from an association representing independent wholesale receivers, were in opposition to revising the United States Standards for Grades of Sweet Cherries. The first commentor stated that the current standard has not been a problem as it is currently written. The second commenter stated that adding standardized row sizes would limit the ability of farmers to market their sweet cherry crop. This commenter also stated that the market already enforced sizing standards that are firm but flexible, which is necessary because sweet cherries are highly perishable and subject to fluctuations in crop size and market conditions. The third commenter stated that there was concern about the viability of the proposal. This commentor suggested several different solutions, however, those solutions are not within the scope of this proposal and therefore will not be addressed in this action. These comments are available by accessing the *http://www.regulations.gov* Web site. After reviewing and considering the comments received, AMS has decided not to proceed with the action. Therefore, the proposed rule published March 30, 2007 (72 FR 15055) is withdrawn. Authority: 7 U.S.C. 1621-1627. Dated: November 29, 2007. Lloyd C. Day, Administrator, Agricultural Marketing Service. [FR Doc. E7-23531 Filed 12-4-07; 8:45 am] BILLING CODE 3410-02-P PENSION BENEFIT GUARANTY CORPORATION 29 CFR Parts 4041 and 4042 RIN 1212-AB14 Disclosure of Termination Information AGENCY: Pension Benefit Guaranty Corporation. ACTION: Proposed rule. SUMMARY: This is a proposed rule to implement section 506 of the Pension Protection Act of 2006 (Pub. L. 109-280) which amends sections 4041 and 4042 of ERISA. These amendments require that a plan administrator disclose information it has submitted to PBGC in connection with a distress termination filing, and that a plan administrator or plan sponsor disclose information it has submitted to PBGC in connection with a PBGC-initiated termination. The new provisions also require PBGC to disclose the administrative record in a PBGC-initiated termination. The disclosures must be made to an affected party upon request. DATES: Comments must be submitted on or before February 4, 2008. ADDRESSES: Comments, identified by Regulatory Information Number (RIN 1212-AB14), may be submitted by any of the following methods: • *Federal eRulemaking Portal: http://www.regulations.gov.* Follow the Web site instructions for submitting comments. • *E-mail: reg.comments@pbgc.gov.* • *Fax:* 202-326-4224. • *Mail or Hand Delivery:* Legislative and Regulatory Department, Pension Benefit Guaranty Corporation, 1200 K Street, NW., Washington, DC 20005-4026. Comments received, including personal information provided, will be posted to *http://www.pbgc.gov.* Copies of comments may also be obtained by writing to Disclosure Division, Office of the General Counsel, Pension Benefit Guaranty Corporation, 1200 K Street, NW., Washington, DC 20005-4026, or calling 202-326-4040 during normal business hours. (TTY and TDD users may call the Federal relay service toll-free at 1-800-877-8339 and ask to be connected to 202-326-4040.) FOR FURTHER INFORMATION CONTACT: Kenneth Cooper, Attorney, Office of the General Counsel; or Catherine Klion, Manager, Regulatory and Policy Division, Legislative and Regulatory Department, Pension Benefit Guaranty Corporation, 1200 K Street, NW., Washington, DC 20005-4026; 202-326-4024. (TTY/TDD users may call the Federal relay service toll-free at 1-800-877-8339 and ask to be connected to 202-326-4024.) SUPPLEMENTARY INFORMATION: Background Pension Benefit Guaranty Corporation (“PBGC”) administers the pension plan termination insurance program under Title IV of the Employee Retirement Income Security Act of 1974, as amended (“ERISA”), 29 U.S.C. 1301-1461. Sections 4041 and 4042 of ERISA govern the termination of single-employer defined benefit pension plans that are subject to Title IV. A plan administrator may initiate a distress termination by sending a notice of intent to terminate to all affected parties pursuant to section 4041(a)(2). Under section 4042 of ERISA, PBGC may itself initiate proceedings to terminate a pension plan if it determines that certain conditions are present. Under section 4041(c), a single-employer plan may terminate in a distress termination if PBGC determines that the requirements of section 4041(c)(2)(B) are met. Before PBGC can make this determination, the plan administrator must provide certain information to PBGC pursuant to section 4041(c)(2)(A). Under section 4041.45(c) of PBGC's regulation on Termination of Single Employer Plans, 29 CFR part 4041, PBGC may also require the submission of additional information. PBGC determines whether a plan meets the criteria for a distress termination or a PBGC-initiated termination through an informal adjudicatory process. If PBGC staff believe that a plan should be terminated, a written recommendation is prepared. With certain exceptions, the recommendation is then reviewed by the Trusteeship Working Group (“TWG”), an interdepartmental body comprised of representatives from PBGC's financial, actuarial, policy, regulatory, and legal departments. If the TWG agrees with the staff recommendation, it forwards its own recommendation concerning the termination to the Director or other designated official (“Deciding Official”). All determinations are documented in a trusteeship decision record. As part of the informal adjudicatory process, PBGC staff may present or make available to the TWG information and documents that relate to a termination recommendation and, if the TWG recommends termination, to the Deciding Official. This material may include information that PBGC has obtained from the plan sponsor or plan administrator, as well as other information that PBGC has obtained or generated. For PBGC-initiated terminations, if the Deciding Official approves the termination, PBGC sends a notice to the plan administrator that the determination has been made (“Notice of Determination”). The plan may then be terminated by agreement or PBGC may apply to the appropriate district court for a decree adjudicating that the plan must be terminated. PPA 2006 Amendments On August 17, 2006, the President signed into law the Pension Protection Act of 2006, Pub. L. 109-280 (“PPA 2006”). Section 506 of PPA 2006 adds disclosure provisions to both sections 4041 and 4042 of ERISA. These provisions allow an affected party to request information related to a plan termination from the plan administrator in the case of a distress termination under section 4041, and from the plan administrator, plan sponsor, and PBGC in the case of a termination under section 4042. “Affected party” is defined in section 4001(a)(21) of ERISA to include each participant in the plan, each beneficiary under the plan, each employee organization representing plan participants, and PBGC. With respect to distress terminations, the new provisions require that a plan administrator that has filed a Notice of Intent to Terminate must provide to an affected party, upon request, information submitted to PBGC in conjunction with the distress termination. This information must be provided not later than 15 days after receipt of the request. One of the new provisions allows a court to limit disclosure of confidential information to an authorized representative of the participants and beneficiaries that agrees to keep the information confidential. With respect to PBGC-initiated terminations, the new provisions require that, following receipt by the plan administrator of a Notice of Determination, the plan sponsor, plan administrator, and PBGC must provide information related to the termination to an affected party upon request. The plan sponsor or plan administrator must, not later than 15 days after receipt of a request, provide copies of any information it provided to PBGC in connection with the termination. PBGC must, not later than 15 days after receipt of a request, provide a copy of the administrative record, including the trusteeship decision record. As in the distress termination provisions, one of the new provisions allows a court to limit disclosure of confidential information to an authorized representative. The new provisions are applicable to terminations initiated on or after August 17, 2006. Proposed Regulation General Provisions Section 506 of PPA 2006 generally requires that information be provided to an affected party upon request. The proposed regulation requires that all requests to the plan administrator, plan sponsor, or PBGC be made in writing, and contain information relating to the plan, and the requestor's status as an affected party. Section 506 of PPA 2006 requires that the plan administrator, plan sponsor, or PBGC provide information not later than 15 days after receipt of a request. A plan administrator or plan sponsor must also provide information not later than 15 days after the submission of additional information to PBGC. For this purpose, because a large amount of information may need to be disclosed in a short time, PBGC is interpreting “day” to mean “business day,” as defined in § 4000.22 of the PBGC's regulation on Filing, Issuance, Computation of Time, and Record Retention, 29 CFR part 4000. Sections 4041(c)(2)(D)(iii) and 4042(c)(3)(D) of ERISA, added by PPA 2006, state that PBGC may prescribe the form and manner of the provision of information under the respective provisions. These provisions state that information may be delivered “in written, electronic or other appropriate form to the extent such form is reasonably accessible” to the individual who makes the request. PBGC's issuance rules in part 4000, subpart B, are appropriate for the provision of information under sections 4041(c)(2)(D)(iii) and 4042(c)(3)(D). Accordingly, the provision of information under section 4041(c)(2)(D)(iii) will be governed by § 4041.3 of PBGC's current regulation, which provides that subpart B of part 4000 applies to issuances relating to plan terminations. The date of issuance will be determined in accordance with part 4000, subpart C, as provided in § 4041.3. With respect to a PBGC-initiated termination, the proposed regulation requires that a plan administrator or plan sponsor respond to a request under section 4042(c)(3)(D) in accordance with part 4000, subpart B. The proposed regulation further provides that the date of issuance is determined in accordance with the rules in part 4000, subpart C. Sections 4041(c)(2)(D)(iii)(II) and 4042(c)(3)(D)(ii) provide that a plan administrator, in the case of a distress termination, and a plan sponsor, in the case of a PBGC-initiated termination, may charge a reasonable fee for any information provided in other than electronic form. Unlike the “form and manner” provisions, the provisions on fees do not give PBGC authority to prescribe what constitutes a reasonable fee. PBGC does not believe it can prescribe such fees in the absence of specific statutory authorization. Information To Be Disclosed by Plan Administrator in Distress Terminations Under section 4041(a)(2) of ERISA, a plan administrator that seeks to terminate a plan in a distress termination must provide a notice of intent to terminate to each affected party. The notice must include information required under PBGC's regulations. Section 4041.43 of PBGC's regulation on Termination of Single Employer Plans specifies the information that must be included in a notice of intent to terminate that is issued to affected parties other than PBGC. The regulation also requires that a separate notice with additional information be filed with PBGC on PBGC Form 600, Distress Termination, Notice of Intent to Terminate. After the notices of intent to terminate have been issued to affected parties other than PBGC and the Form 600 has been filed with PBGC, additional information must be submitted to PBGC at a later date in accordance with section 4041(c)(2) of ERISA and § 4041.45 of the regulation. Section 4041(c)(2)(D)(i) of ERISA, added by PPA 2006, states in relevant part: A plan administrator that has filed a notice of intent to terminate under subsection (a)(2) shall provide to an affected party any information provided to the corporation under subsection (a)(2) not later than 15 days after—
(I)receipt of a request from the affected party for the information; or
(II)the provision of new information to the corporation relating to a previous request. PBGC is interpreting this provision as requiring disclosure of the Form 600 and any additional information submitted to PBGC under section 4041(c)(2) of ERISA. PBGC recognizes that because the statute references only section 4041(a)(2), which addresses the notice of intent to terminate, it is possible to read section 4041(c)(2)(D)(i) as requiring that a plan administrator disclose only the Form 600. Such a narrow reading, however, would be at odds with Congress's intent to provide greater disclosure of information submitted to PBGC in connection with a distress termination. The Technical Explanation of PPA 2006 prepared by the staff of the Joint Committee on Taxation states that section 506 requires “a plan administrator to provide an affected party with any information provided to the PBGC in connection with the proposed plan termination.” The broad reference to “any information * * * in connection with the proposed plan termination”—without the limitation to section 4041(a)(2)—suggests the required disclosures include information submitted to PBGC under section 4041(c)(2), in addition to the Form 600 filed pursuant to section 4041(a)(2) and the implementing regulation. Further, because a plan administrator files the Form 600 once, requiring disclosure of only the Form 600 would give no effect to the requirement in section 4041(c)(2)(D)(i)(II) that a plan administrator must provide copies of new information it submits to PBGC not later than 15 days after such submission. In light of these considerations, the proposed regulation provides that, upon written request of an affected party, a plan administrator must provide copies of any information submitted to PBGC pursuant to sections 4041(a)(2) and 4041(c)(2) of ERISA and sections 4041.43 and 4041.45 of the regulation not later than 15 business days after receipt of the request. If PBGC Form 600 has not been filed with PBGC at the time of the request, the proposed regulation requires the plan administrator to provide the information not later than 15 business days after PBGC Form 600 is filed. In addition, the proposed regulation requires that if the plan administrator has provided information in response to a request and later submits additional information to PBGC in connection with the proposed distress termination, the plan administrator must, not later than 15 business days after the submission, provide copies of that information to any affected party that has made a previous request. If a plan administrator fails to provide information under section 4041(c)(2)(D)(i) of ERISA and the implementing regulation within the specified timeframe, PBGC may assess penalties under section 4071 of ERISA. Information To Be Disclosed by Plan Administrator and Plan Sponsor in a Termination Initiated by PBGC Section 4042(c)(3) of ERISA imposes disclosure requirements on the plan administrator, the plan sponsor, and PBGC in connection with a PBGC-initiated termination. With regard to the plan sponsor and plan administrator, the statute provides that, upon request: A plan sponsor or plan administrator of a single-employer plan that has received a notice from [PBGC] of a determination that the plan should be terminated under this section shall provide to an affected party any information provided to the corporation in connection with the plan termination. Section 4042(c)(3)(A)(i). Under this provision, an affected party may request termination information only after the plan administrator has received a Notice of Determination from PBGC that the plan should be terminated. The proposed regulation adopts an assumed receipt date of 3 business days after PBGC issues the Notice of Determination. Thus, a request for information may be made on or after the third business day after the Notice of Determination is issued. Once such a request is received by the plan administrator or plan sponsor, the information must be provided not later than 15 business days after receipt of the request. As in the case of a distress termination, if new information relating to the request is submitted to PBGC, copies must be provided, not later than 15 business days after the submission, to any affected party that has made a previous request. A plan administrator or plan sponsor that fails to provide information requested under section 4042(c)(3) of ERISA and the implementing regulation within the specified timeframe may be subject to penalties under section 4071 of ERISA. Disclosure of Administrative Record by PBGC in Terminations Initiated by PBGC Section 4042(c)(3)(A)(ii) of ERISA states that, upon request of an affected party, PBGC “shall provide a copy of the administrative record, including the trusteeship decision record of a termination of a plan” not later than 15 days after receipt of the request. The right to request a copy of the administrative record arises only after a Notice of Determination that the plan should be terminated is received by the plan administrator. As in the provisions relating to requests for information from the plan administrator or plan sponsor, the proposed regulation adopts an assumed receipt date of 3 business days after PBGC issues the Notice of Determination. Thus, a request for the administrative record may be made on or after the third business day after the Notice of Determination is issued. The proposed regulation further provides that PBGC will send the administrative record to the affected party not later than 15 business days after it receives the request, and will use measures reasonably calculated to ensure actual receipt (including electronic measures). This standard is analogous to the requirements in Part 4000, subpart B, that the plan administrator and plan sponsor must follow. Disclosure of Confidential Information by Plan Administrator and Plan Sponsor Sections 4041(c)(2)(D)(ii)(I) and 4042(c)(3)(C)(i) of ERISA prohibit the disclosure by the plan administrator, in connection with a distress termination, and the plan administrator or plan sponsor, in connection with a PBGC-initiated termination, of information “that may directly or indirectly be associated with, or otherwise identify, an individual participant or beneficiary.” The proposed regulation incorporates this restriction. In addition, both sections 4041(c)(2)(D)(ii)(I) and 4042(c)(3)(C)(i) of ERISA provide a means for a plan sponsor or plan administrator to seek to restrict the disclosure of confidential information that would be exempt from disclosure under Freedom of Information Act (“FOIA”). Under section 552(b)(4) of FOIA, an agency has discretion to withhold documents on matters that are “trade secrets and commercial or financial information obtained from a person and privileged or confidential.” Sections 4041(c)(2)(D)(ii)(II) and 4042(c)(3)(C)(ii) provide that a court may limit disclosure of confidential information described in section 552(b) of FOIA, 5 U.S.C. 552(b), to “authorized representatives * * * of the participants or beneficiaries that agree to ensure the confidentiality of such information.” Section 4041(c)(2)(D)(iv) defines “authorized representative” for purposes of both sections 4041 and 4042 as “any employee organization representing participants in the pension plan.” Accordingly, the proposed regulation provides that a plan administrator that has received a request for information in connection with a distress termination, and a plan administrator or plan sponsor that has received a request for information in connection with a PBGC-initiated termination, may seek a court order under which confidential information described in 5 U.S.C. 552(b) will be disclosed only to authorized representatives (within the meaning of section 4041(c)(2)(D)(iv) of ERISA) that agree to ensure the confidentiality of such information, and will not be disclosed to other affected parties. Typically, the authorized representative will be a labor union in a plan maintained in conjunction with a collective bargaining agreement. However, there may be no authorized representative where the participants are not covered under a collective bargaining agreement. The new PPA 2006 provisions do not address limiting disclosure of confidential information in such cases. Disclosure of Confidential Information by PBGC By its terms, section 4042(c)(3)(C)(i) of ERISA, which prohibits disclosure of information that identifies an individual participant or beneficiary, applies to a plan administrator or plan sponsor, but not to PBGC. This may be because PBGC is already prohibited from disclosing such information. Under the Privacy Act, 5 U.S.C. 552a, PBGC is prohibited from disclosing personally identifiable information with regard to a participant or beneficiary, without the individual's written consent. There are narrow exceptions stated in 5 U.S.C. 552a(b), but none apply to disclosure of identifying information that may be part of the administrative record in a PBGC-initiated termination. Accordingly, the proposed regulation states that PBGC shall not disclose any portions of the administrative record that are prohibited from disclosure under 5 U.S.C. 552a. With respect to disclosure of confidential information, PBGC believes that, under the provisions added by section 506 of PPA 2006, it must disclose any part of the administrative record that contains confidential information, except as limited by a court. Unlike FOIA, which specifies categories of information that are exempt from disclosure, there are no exemptions under section 4042(c)(3) of ERISA. Rather, disclosure may only be limited by a court to the extent provided in section 4042(c)(3)(C)(ii). In addition, PBGC believes that the Trade Secrets Act, 18 U.S.C. 1805, does not apply to disclosure of the administrative record under section 4042(c)(3) of ERISA. The Trade Secrets Act prohibits disclosure of trade secrets and related information “to any extent not authorized by law.” PBGC believes that the disclosure requirements with respect to PBGC, as set forth in section 4042(c)(3), compel PBGC to disclose the administrative record upon request, subject only to limitation by a court as provided in section 4042(c)(3)(C)(ii). As a result, such disclosure is “authorized by law.” Additionally, PBGC does not believe that information it receives under sections 4010 or 4043 of ERISA that becomes part of an administrative record is exempt from disclosure under section 4042(c)(3). Information and documents submitted to PBGC under those sections are “exempt from disclosure under [FOIA], and * * * may not be made public, except as may be relevant to any administrative or judicial action or proceeding.” 29 U.S.C. 1310(c), 1343(f). The exemption from disclosure under FOIA does not apply to disclosure of the administrative record because requests for the administrative record are made under section 4042(c)(3), not under FOIA. In addition, since material in the administrative record relates to an administrative action or proceeding, the restriction on making such material public does not apply. To address the potential disclosure of confidential information that is part of an administrative record, the proposed regulation provides that PBGC will promptly notify the plan administrator and plan sponsor upon receipt of a request for the administrative record from an affected party. PBGC expects that this notification will be made not later than the second business day after receipt of the request. Under the proposed regulation, the plan administrator or plan sponsor may then seek a court order under which disclosure of those portions of the administrative record that contain confidential information described in 5 U.S.C. 552(b) will be made only to authorized representatives (within the meaning of section 4041(c)(2)(D)(iv) of ERISA) that agree to ensure the confidentiality of such information, and will not be disclosed to other affected parties. The proposed regulation further provides that if PBGC receives such a court order prior to the 15th business day after PBGC receives a request for the administrative record, PBGC will disclose confidential information that is part of the administrative record as provided in the order. Applicability The amendments in this proposed regulation would be applicable to terminations initiated on or after August 17, 2006, but only to requests for information made on or after the effective date of the final rule. Compliance With Rulemaking Guidelines E.O. 12866 The PBGC has determined, in consultation with the Office of Management and Budget, that this rule is a “significant regulatory action” under Executive Order 12866. The Office of Management and Budget has therefore reviewed this notice under E.O. 12866. Pursuant to section 1(b)(1) of E.O. 12866 (as amended by E.O. 13422), PBGC identifies the following specific problems that warrant this agency action: • The statute does not specify the form and manner in which information requested must be provided to the affected party, but instead states that PBGC may prescribe such requirements. Without rules for how the information is to be provided, plan administrators and plan sponsors will not know whether the method they choose for providing requested information is appropriate. • There is uncertainty in the statute with respect to the information that a plan administrator that has filed a notice of intent to terminate a plan in a distress termination must provide, upon request, to an affected party. Without rules for what information is to be provided, plan administrators will not know what information they must provide, and affected parties will not know what information they are entitled to receive. • There is uncertainty in the statute with respect to determining the date as of which an affected party may request information provided to PBGC in connection with a PBGC-initiated termination. Without clarification, affected parties will not know when they can begin to request information, and plan administrators, plan sponsors, and PBGC will not know when their obligation to provide information arises. • Unlike FOIA, which specifies categories of information that are exempt from disclosure, section 4042(c)(3)(c)(ii) of ERISA provides only that a court may limit disclosure by PBGC of confidential information described in section 552(b) to an authorized representative. The statute does not specify when and by whom court limitation may be sought in cases where PBGC receives a request for the administrative record. Without clarification, plan administrators and plan sponsors will not know how disclosure of confidential information they submitted to PBGC can be limited. Regulatory Flexibility Act PBGC certifies under section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) that the amendments in this proposed regulation would not have a significant economic impact on a substantial number of small entities. Accordingly, as provided in section 605 of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), sections 603 and 604 do not apply. The proposed rule would implement statutory changes made by Congress. It would prescribe the form and manner for providing requested information and clarify the type of information that must be provided and the timeframes for providing such information. It would also provide for notification by PBGC to the plan sponsor and plan administrator of a request for an administrative record so that the plan sponsor or plan administrator can, if it chooses, seek a court order limiting disclosure of confidential information as provided in the statute. These provisions impose no significant burden beyond the burden imposed by statute. Paperwork Reduction Act PBGC is submitting the information collection requirements under this proposed regulation to the Office of Management and Budget for review and approval under the Paperwork Reduction Act. Copies of PBGC's request may be obtained free of charge by contacting the Disclosure Division of the Office of the General Counsel of PBGC, 1200 K Street, NW., Washington, DC 20005, 202-326-4040. This proposed regulation would modify information collection requirements under OMB control number 1212-0036 (expires September 30, 2007). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. PBGC needs this information in order to provide sufficient information to affected parties about the termination or possible termination of their pension plans. Section 506 of PPA 2006 has been in effect for less than a year, and PBGC is not aware of any requests for information that have been made to date under its provisions. PBGC estimates that 100 plans with a total of 100,000 participants will terminate annually, and that 10,000 participants (and other affected parties) will annually make requests for information. PBGC estimates that the total annual burden for the collection of information will be about 30,000 hours and $250,000. Comments on the paperwork provisions under this proposed regulation should be mailed to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Pension Benefit Guaranty Corporation, Washington, DC 20503. Although comments may be submitted through February 4, 2008, the Office of Management and Budget requests that comments be received on or before January 4, 2008 to ensure their consideration. Comments may address (among other things)— • Whether the proposed collection of information is needed for the proper performance of PBGC's functions and will have practical utility; • The accuracy of PBGC's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; • Enhancement of the quality, utility, and clarity of the information to be collected; and • Minimizing the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. List of Subjects 29 CFR Part 4041 Disclosure, Pensions, Termination of pension plans. 29 CFR Part 4042 Disclosure, Pensions, Termination of pension plans. For the reasons given above, PBGC proposes to amend 29 CFR chapter XL as follows: PART 4041—TERMINATION OF SINGLE-EMPLOYER PLANS 1. The authority citation for part 4041 continues to read as follows: Authority: 29 U.S.C. 1302(b)(3), 1341, 1344, 1350. 2. New § 4041.51 is added to 29 CFR part 4041 to read as follows: § 4041.51 Disclosure of information by plan administrator in distress termination.
(a)*Request for Information.*
(1)*In general.* If a notice of intent to terminate under § 4041.43 is issued with respect to a plan, an affected party may make a request to the plan administrator for information submitted to PBGC under sections 4041(a)(2) and 4041(c)(2) of ERISA and §§ 4041.43 and 4041.45.
(2)*Requirements.* A request under paragraph
(a)of this section must:
(i)Be in writing to the plan administrator;
(ii)State the name of the plan and that the request is for information submitted to PBGC with respect to the application for a distress termination of the plan;
(iii)State the name of the person making the request for information and such person's relationship to the plan (e.g., plan participant), and that such relationship meets the definition of affected party under § 4001.2 of this chapter; and
(iv)Be signed by the person making the request.
(b)*Response by Plan Administrator.*
(1)*Information.* The information that a plan administrator must provide in response to a request under paragraph
(a)of this section includes the PBGC Form 600, and any information submitted to PBGC pursuant to section 4041(c)(2) of ERISA and § 4041.45.
(2)*Timing of response.* A plan administrator that receives a request under paragraph
(a)of this section must provide the information requested not later than the 15th business day (as defined in § 4000.22 of this chapter) after receipt of the request.
(3)*Deferral of due date.* If, at the time the plan administrator receives a request under paragraph
(a)of this section, the plan administrator has not filed a PBGC Form 600, the plan administrator must provide the information requested under paragraph
(a)not later than the 15th business day (as defined in § 4000.22 of this chapter) after a PBGC Form 600 is filed with PBGC.
(4)*Supplemental responses.* If, at any time after the later of the receipt of a request under paragraph
(a)of this section, or the filing of PBGC Form 600, the plan administrator submits additional information to PBGC with respect to the plan termination under section 4041(c)(2) of ERISA and § 4041.45, the plan administrator must, not later than the 15th business day (as defined in § 4000.22 of this chapter) after each additional submission, provide the additional information to any affected party that has made a request under paragraph
(a)of this section.
(5)*Confidential information.*
(i)In responding to a request under paragraph
(a)of this section, the plan administrator shall not provide information that may, directly or indirectly, identify an individual participant or beneficiary of the plan.
(ii)A plan administrator that has received a request under paragraph
(a)of this section may seek a court order under which confidential information described in section 552(b) of title 5, United States Code—
(A)Will be disclosed only to authorized representatives (within the meaning of section 4041(c)(2)(D)(iv) of ERISA) that agree to ensure the confidentiality of such information, and,
(B)Will not be disclosed to other affected parties. 3. New part 4042 is added to chapter XL to read as follows: PART 4042—SINGLE-EMPLOYER PLAN TERMINATION INITIATED BY PBGC Subpart A—General Provisions Sec. 4042.1 Purpose and scope. 4042.2 Definitions. 4042.3 Issuance rules. Subpart B—Reserved Subpart C—Disclosure 4042.4 Disclosure of information by plan administrator or plan sponsor. 4042.5 Disclosure of administrative record by PBGC. Authority: 29 U.S.C. 1302(b)(3), 1342. Subpart A—General Provisions § 4042.1 Purpose and scope. This part sets forth rules and procedures relating to single-employer plan terminations initiated by PBGC under section 4042 of ERISA. § 4042.2 Definitions. The following terms are defined in § 4001.2 of this chapter: affected party, ERISA, PBGC, and plan administrator. § 4042.3 Issuance rules. PBGC applies the rules in subpart B of part 4000 of this chapter to determine permissible methods of issuance under this part. PBGC applies the rules in subpart C of part 4000 of this chapter to determine the date that an issuance under this part was provided. Subpart B—Reserved Subpart C—Disclosure § 4042.4 Disclosure of information by plan administrator or plan sponsor.
(a)*Request for Information.*
(1)*In general.* Beginning on the third business day (as defined in § 4000.22 of this chapter) after PBGC has issued a notice under section 4042 of ERISA that a plan should be terminated, an affected party may make a request to the plan sponsor or the plan administrator (or both) for any information that such plan administrator or plan sponsor has submitted to PBGC in connection with the plan termination.
(2)*Requirements.* A request under paragraph
(a)of this section must:
(i)Be in writing to the plan administrator or plan sponsor;
(ii)State the name of the plan and that the request is for information submitted to PBGC in connection with the plan termination;
(iii)State the name of the person making the request for information and such person's relationship to the plan (e.g., plan participant), and that such relationship meets the definition of affected party under § 4001.2 of this chapter; and
(iv)Be signed by the person making the request.
(b)*Response by Plan Administrator or Plan Sponsor.*
(1)*Timing of response.* A plan administrator or plan sponsor that receives a request under paragraph
(a)of this section must provide the information requested not later than the 15th business day (as defined in § 4000.22 of this chapter) after receipt of the request.
(2)*Supplemental responses.* If, at any time after receipt of a request under paragraph (a), the plan administrator or plan sponsor submits additional information to PBGC in connection with the plan termination, the plan administrator or plan sponsor must provide such additional information to any affected party that has made a request under paragraph (a), not later than the 15th business day (as defined in § 4000.22 of this chapter) after the information is submitted to PBGC.
(3)*Confidential information.*
(i)In responding to a request under paragraph
(a)of this section, the plan administrator or plan sponsor shall not provide information that may, directly or indirectly, identify an individual participant or beneficiary.
(ii)A plan administrator or plan sponsor that has received a request under paragraph
(a)of this section may seek a court order under which confidential information described in section 552(b) of title 5, United States Code—
(A)Will be disclosed only to authorized representatives (within the meaning of section 4041(c)(2)(D)(iv) of ERISA) that agree, to ensure the confidentiality of such information, and
(B)Will not be disclosed to other affected parties. § 4042.5 Disclosure of administrative record by PBGC.
(a)*Request for Administrative Record.*
(1)*In general.* Beginning on the third business day (as defined in § 4000.22 of this chapter) after PBGC has issued a notice under section 4042 of ERISA that a plan should be terminated, an affected party with respect to the plan may make a request to PBGC for the administrative record of PBGC's determination that the plan should be terminated.
(2)*Requirements.* A request under paragraph
(a)of this section must:
(i)Be in writing;
(ii)State the name of the plan and that the request is for the administrative record with respect to a notice issued by PBGC under section 4042 of ERISA that a plan should be terminated;
(iii)State the name of the person making the request, the person's relationship to the plan (e.g., plan participant), and that such relationship meets the definition of affected party under § 4001.2 of this chapter; and
(iv)Be signed by the person making the request.
(3)A request under paragraph
(a)of this section must be sent to PBGC's Disclosure Officer at the address provided on PBGC's Web site. To expedite processing, the request should be prominently identified as an “Administrative Record Request.”
(b)*PBGC Response to Request for Administrative Record.*
(1)*Notification of plan administrator and plan sponsor.* Upon receipt of a request under paragraph
(a)of this section, PBGC will promptly notify the plan administrator and plan sponsor that it has received a request for the administrative record, and the date by which PBGC will provide the information to the affected party that made the request.
(2)*Confidential information.*
(i)In responding to a request under paragraph
(a)of this section, PBGC will not disclose any portions of the administrative record that are prohibited from disclosure under the Privacy Act, 5 U.S.C. 552a.
(ii)A plan administrator or plan sponsor that has received notification pursuant to paragraph (b)(1) of this section may seek a court order under which those portions of the administrative record that contain confidential information described in section 552(b) of title 5, United States Code—
(A)Will be disclosed only to authorized representatives (within the meaning of section 4041(c)(2)(D)(iv)) of ERISA) that agree to ensure the confidentiality of such information, and
(B)Will not be disclosed to other affected parties.
(iii)If, before the 15th business day (as defined in § 4000.22 of this chapter) after PBGC has received a request under paragraph (a), PBGC receives a court order as described in paragraph (b)(2)(ii) of this section, PBGC will disclose those portions of the administrative record that contain confidential information described in section 552(b) of title 5, United States Code, only as provided in the order.
(3)*Timing of response.* PBGC will send the administrative record to the affected party that made the request not later than the 15th business day (as defined in § 4000.22 of this chapter) after it receives the request.
(4)*Form and manner.* PBGC will provide the administrative record using measures (including electronic measures) reasonably calculated to ensure actual receipt of the material by the intended recipient. Issued in Washington, DC, this 30th day of November, 2007. Charles E.F. Millard, Interim Director, Pension Benefit Guaranty Corporation. [FR Doc. E7-23577 Filed 12-4-07; 8:45 am] BILLING CODE 7709-01-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2007-0105] RIN 1625-AA09 Drawbridge Operation Regulations; Biscayne Bay, Atlantic Intracoastal Waterway, Miami River, and Miami Beach Channel, Miami-Dade County, FL AGENCY: Coast Guard, DHS. ACTION: Notice of proposed rulemaking. SUMMARY: The Coast Guard proposes to change the regulations governing the operation of the east and west spans of the Venetian Causeway bridges across the Miami Beach Channel on the Atlantic Intracoastal Waterway, the Miami Avenue bridge and the Brickell Avenue bridge across the Miami River, Miami-Dade County. This proposed rule would allow these bridges to remain in the closed position for periods of time during the last Sunday in January during the running of an annual marathon. DATES: Comments and related material must reach the Coast Guard on or before January 4, 2008. ADDRESSES: You may submit comments identified by Coast Guard docket number USCG-2007-0105 to the Docket Management Facility at the U.S. Department of Transportation. To avoid duplication, please use only one of the following methods:
(1)*Online: http://www.regulations.gov* .
(2)*Mail:* Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
(3)*Hand delivery:* Room W12-140 on the Ground Floor of the West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202-366-9329. *Fax:* 202-493-2251. FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed rule, call Mr. Gwin Tate, Seventh Coast Guard District, Bridge Administration Branch,
(305)415-6747. If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202-366-9826. SUPPLEMENTARY INFORMATION: Public Participation and Request for Comments We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted, without change, to *http://www.regulations.gov* and will include any personal information you have provided. We have an agreement with the Department of Transportation
(DOT)to use the Docket Management Facility. Please see DOT's “Privacy Act” paragraph below. Submitting Comments If you submit a comment, please include the docket number for this rulemaking (USCG-2007-0105), indicate the specific section of this document to which each comment applies, and give the reason for each comment. We recommend that you include your name and a mailing address, an e-mail address, or a phone number in the body of your document so that we can contact you if we have questions regarding your submission. You may submit your comments and material by electronic means, mail, fax, or delivery to the Docket Management Facility at the address under ADDRESSES ; but please submit your comments and material by only one means. If you submit them by mail or delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing. If you submit them by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period. We may change this proposed rule in view of them. Viewing Comments and Documents To view comments, as well as documents mentioned in this preamble as being available in the docket, go to *http://www.regulations.gov* at any time, click on “Search for Dockets,” and enter the docket number for this rulemaking (USCG-2007-0105) in the Docket ID box, and click enter. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Privacy Act Anyone can search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the Department of Transportation's Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477), or you may visit *http://DocketsInfo.dot.gov* . Public Meeting We do not now plan to hold a public meeting. But you may submit a request for one to the Docket Management Facility at the address under ADDRESSES explaining why one would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the **Federal Register** . Background and Purpose As in previous years, the Miami Marathon Director requested that the Coast Guard change the existing regulations governing the operation of the east and west spans of the Venetian Causeway bridges, the Brickell Avenue bridge and the Miami Avenue bridge to allow them to remain in the closed position during periods of time on the last Sunday in January during the running of an annual marathon. Previously, the Coast Guard issued a temporary rule that provided for these bridge closings, which range from 6:00 a.m. through 12:30 p.m. The marathon route will pass over these four bridges and any bridge opening would disrupt the race. Based on the limited amount of time the bridges would be closed, the proposed rule would still provide for the reasonable needs of navigation on the day of the event. The east and west spans of the Venetian Causeway bridges are located between Miami and Miami Beach. We published the current regulation governing the operation of the east and west spans, mile 1088.6 at Miami, of the Venetian Causeway bridges on April 16, 2007, becoming effective May 16, 2007, which requires the bridges to open on signal, except that from 7 a.m. to 7 p.m., Monday through Friday, except Federal holidays, the drawbridges will open on the hour and half-hour. The regulation governing the Miami Avenue bridge, mile 0.3, at Miami, is published at 33 CFR 117.305(c) and requires that the bridge open on signal; except that, from 7:35 a.m. to 8:59 a.m., 12:05 p.m. to 12:59 p.m. and 4:35 p.m. to 5:59 p.m., Monday through Friday, except Federal holidays, the draw need not open for the passage of vessels. The regulation governing the Brickell Avenue bridge, mile 0.1, at Miami, is published in 33 CFR 117.305(d) and requires that the bridge open on signal; except that, from 7 a.m. to 7 p.m., Monday through Friday, except Federal holidays, the draw need open only on the hour and half-hour. From 7:35 a.m. to 8:59 a.m., 12:05 p.m. to 12:59 p.m. and 4:35 p.m. to 5:59 p.m., Monday through Friday except Federal holidays, the draw need not open for the passage of vessels. This proposed rule would not adversely affect the reasonable needs of navigation due to the limited time (six and one-half hours) that the bridges would remain in the closed position. Discussion of Proposed Rule The Coast Guard proposes to change the operating regulations of the east and west spans of the Venetian Causeway bridges, the Miami Avenue bridge and the Brickell Avenue bridge annually on the last Sunday in January. This proposed rule would allow, annually on the last Sunday in January, the east span of the Venetian Causeway bridge to remain closed from 6 a.m. to 9 a.m., and the west span of the Venetian Causeway bridge to remain closed from 6:10 a.m. to 9:35 a.m. Annually, on the last Sunday in January, the Miami Avenue bridge would remain closed from 6:25 a.m. to 10:20 a.m., and the Brickell Avenue bridge would remain closed from 7:10 a.m. to 12:30 p.m. Public vessels of the United States and vessels in distress would be allowed to pass at any time, upon signal. In past years, these schedule changes have been made annually by using a temporary final rule. This NPRM proposes to make the change permanently in the regulation, to prevent the need for annual publications in the **Federal Register** . Regulatory Evaluation This proposed rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security. We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation is unnecessary. The short duration of time during the morning of the last Sunday in January, that the bridges would remain in the closed position to facilitate the running of the marathon would have little, if any, economic impact, as evidenced by the lack of impact in the past years, when the proposed change was implemented on a temporary basis. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this proposed rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. This proposed rule would affect the following entities, some of which may be small entities: The owners or operators of vessels that would require passage through these bridges during the morning hours annually on the last Sunday in January. These vessels would not be able to pass through these bridges during the effective times of this proposed rule. However, due to the limited effective times of this proposed rule and the nominal amount of marine traffic expected during the early and late morning hours on a Sunday at this time of year, this proposed rule would not have a significant economic impact on a substantial number of small entities. If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed under for FOR FURTHER INFORMATION CONTACT . The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. Collection of Information This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.). Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this proposed rule under that Order and have determined that it does not have implications for federalism. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this proposed rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This proposed rule would not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. Civil Justice Reform This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Protection of Children We have analyzed this proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children. Indian Tribal Governments This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would 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. Energy Effects We have analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. Technical Standards The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this proposed rule under Commandant Instruction M16475 which guides the Coast Guard in complying with the National Environmental Policy Act of 1969
(NEPA)(42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is not likely to have a significant effect on the human environment because it simply promulgates the operating regulations or procedures for drawbridges. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule. List of Subjects in 33 CFR Part 117 Bridges. For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows: PART 117—DRAWBRIDGE OPERATION REGULATIONS 1. The authority citation for part 117 continues to read as follows: Authority: 33 U.S.C. 499; 33 CFR 1.05-1(g); Department of Homeland Security Delegation No. 0170.1. 2. In § 117.261, revise paragraph
(nn)to read as follows: § 117.261 Atlantic Intracoastal Waterway from St. Marys River to Key Largo.
(nn)*The Venetian Causeway Bridge (West), mile 1088.6 at Miami.* The draw shall open on signal; except that, from 7 a.m. to 7 p.m., Monday through Friday, except Federal holidays, the draw need only open on the hour and half-hour; except that on the last Sunday in January, the draw need not open from 6:10 a.m. until 9:35 a.m. 3. Revise § 117.269 to read as follows: § 117.269 Biscayne Bay. The Venetian Causeway Bridge (East), between Miami and Miami Beach, shall open on signal; except that, from 7 a.m. to 7 p.m., Monday through Friday, except Federal holidays, the draw need only open on the hour and half-hour; except that on the last Sunday in January, the draw need not open from 6 a.m. until 9 a.m. Public vessels of the United States and vessels in distress shall be allowed to pass at any time, upon signal. 4. In § 117.305, revise paragraphs
(c)and
(d)to read as follows: § 117.305 Miami River.
(c)The draws of the Miami Avenue Bridge, mile 0.3, and the S.W. Second Avenue Bridge, mile 0.5, at Miami, shall open on signal; except that the draw need not open for the passage of vessels at the following times:
(1)From 7:35 a.m. to 8:59 a.m., Monday through Friday, except Federal holidays,
(2)From 12:05 p.m. to 12:59 p.m., Monday through Friday, except Federal holidays,
(3)From 4:35 p.m. to 5:59 p.m., Monday through Friday, except Federal holidays, and
(4)From 6:25 a.m. to 10:20 a.m., on the last Sunday in January.
(d)The draw of the Brickell Avenue Bridge, mile 0.1, at Miami, shall open on signal; except that, from 7 a.m. to 7 p.m., Monday through Friday except Federal holidays, the draw need open only on the hour and half-hour; except that the draw need not open for the passage of vessels at the following times:
(1)From 7:35 a.m. to 8:59 a.m., Monday through Friday, except Federal holidays,
(2)From 12:05 p.m. to 12:59 p.m., Monday through Friday, except Federal holidays,
(3)From 4:35 p.m. to 5:59 p.m., Monday through Friday, except Federal holidays, and
(4)From 7:10 a.m. to 12:30 p.m., on the last Sunday in January. Dated: November 21, 2007. William Lee, Capt., USCG, Acting District Commander, Seventh Coast Guard District. [FR Doc. E7-23564 Filed 12-4-07; 8:45 am] BILLING CODE 4910-15-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2006-1021; FRL-8501-4] Approval and Promulgation of Air Quality Implementation Plans; Minnesota AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve State Implementation Plan
(SIP)revisions to the sulfur dioxide (SO <sup>2</sup> ) requirements for Northern States Power Company, doing business as Xcel Energy, Inver Hills Generating Plant (Inver Hills), located in Inver Grove Heights, Dakota County, Minnesota. The revisions make the limits of the sulfur content in its fuel and its sulfur dioxide emissions more stringent, and prohibit the burning of residual fuel oil. The revisions allow the facility to use simpler methods to analyze the sulfur content of its fuel. Because the sulfur dioxide emission limits are being reduced, the air quality of Dakota County will be protected. DATES: Comments must be received on or before January 4, 2008. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-OAR-2006-1021, by one of the following methods: 1. *http://www.regulations.gov:* Follow the on-line instructions for submitting comments. 2. *E-mail: mooney.john@epa.gov.* 3. *Fax:* (312)886-5824. 4. *Mail:* John M. Mooney, Chief, Criteria Pollutant Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. 5. *Hand Delivery:* John M. Mooney, Chief, Criteria Pollutant Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. Such deliveries are only accepted during the Regional Office normal hours of operation, and special arrangements should be made for deliveries of boxed information. The Regional Office official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m. excluding Federal holidays. Please see the direct final rule which is located in the Rules section of this **Federal Register** for detailed instructions on how to submit comments. FOR FURTHER INFORMATION CONTACT: Matt Rau, Environmental Engineer, Criteria Pollutant Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604,
(312)886-6524, *rau.matthew@epa.gov.* SUPPLEMENTARY INFORMATION: In the Final Rules section of this **Federal Register** , EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this rule, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. 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. For additional information, see the direct final rule which is located in the Rules section of this **Federal Register** . Dated: November 20, 2007. Bharat Mathur, Acting Regional Administrator, Region 5. [FR Doc. E7-23497 Filed 12-4-07; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 071029623-7624-01] RIN 0648-AW21 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Commercial Dolphin/Wahoo Fishery off the Southern Atlantic States; Control Date AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Advanced notice of proposed rulemaking; request for comments. SUMMARY: NMFS announces that it is considering, and is seeking public comment on proposed rulemaking to control future access to the commercial dolphin/wahoo fishery operating in the exclusive economic zone (EEZ)of the South Atlantic. If changes to the management regime are developed and implemented under the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), a control date could be used to limit the number of participants in the fishery. This announcement is intended, in part, to promote awareness of the potential eligibility criteria for future access so as to discourage speculative entry into the fishery while the South Atlantic Fishery Management Council (Council) and NMFS consider whether and how access to the dolphin/wahoo commercial fishery should be controlled. DATES: Written comments must be received on or before 5 p.m., local time, January 4, 2008. ADDRESSES: You may submit comments, identified by 0648-AW03, by any one of the following methods: • Electronic Submissions: Submit all electronic public comments via the Federal eRulemaking Portal *http://www.regulations.gov* . • Fax: Attn: Kate Michie 727-824-5308. • Mail: Kate Michie, NMFS Southeast Regional Office, Sustainable Fisheries Division, 263 13th Avenue South, St. Petersburg, FL 33701. Instructions: All comments received are a part of the public record and will generally be posted to *http://www.regulations.gov* without change. All Personal Identifying Information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information. NMFS will accept anonymous comments. Attachments to electronic comments will be accepted in Microsoft Word, Excel, WordPerfect, or Adobe PDF file formats only. FOR FURTHER INFORMATION CONTACT: Kim Iverson, Public Information Officer, South Atlantic Fishery Management Council; toll free 1-866-SAFMC-10 or 843-571-4366; *kim.iverson@safmc.net* . SUPPLEMENTARY INFORMATION: At the September 2007 Council meeting, the Council recommended a control date of December 5, 2007 for the commercial dolphin/wahoo fishery. The control date would apply to persons who are contemplating entering the commercial dolphin/wahoo fishery in the EEZ of the South Atlantic region. The Council requested that this control date be published in the **Federal Register** to notify fishermen that if they enter such a fishery after December 5, 2007, they may not be assured of future access if the Council and/or NMFS decide to limit entry or impose other measures to manage these fisheries. Establishment of the control date would allow the Council to evaluate the level of participation in the subject fishery and address any level of overcapacity. Control dates are intended to discourage speculative entry into a fishery, as new entrants entering the fishery after the control date are forewarned that they are not guaranteed future participation in the fishery. Establishment of this control date does not commit the Council or NMFS to any particular management regime or criteria for entry into the commercial dolphin/wahoo fishery. Fishermen are not guaranteed future participation in the fishery regardless of their level of participation before or after the control date. The Council may recommend a different control date or it may recommend a management regime that does not involve a control date. Other criteria, such as documentation of landings or fishing effort, may be used to determine eligibility for participation in a limited access fishery. The Council and/or NMFS also may choose to take no further action to control entry or access to the fisheries, in which case the control date may be rescinded. Any action by the Council will be taken pursuant to the requirements for fishery management plan and amendment development established under the Magnuson-Stevens Act. This notification also gives the public notice that interested participants should locate and preserve records that substantiate and verify their participation in the commercial dolphin/wahoo fishery in the South Atlantic EEZ. Authority: 16 U.S.C. 1801 *et seq.* Dated: November 29, 2007. Samuel D. Rauch III, Deputy Assistant Administrator For Regulatory Programs, National Marine Fisheries Service. [FR Doc. E7-23596 Filed 12-4-07; 8:45 am] BILLING CODE 3510-22-S 72 233 Wednesday, December 5, 2007 Notices AGENCY FOR INTERNATIONAL DEVELOPMENT Notice of Public Information Collection Requirements Submitted to OMB for Review SUMMARY: U.S. Agency for International Development (USAID) has submitted the following information collections to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding this information collection are best assured of having their full effect if received within 30 days of this notification. Comments should be sent via e-mail to *David_Rostker@omb.eop.gov* or fax to 202-395-7285. Copies of submission may be obtained by calling
(202)712-1365. SUPPLEMENTARY INFORMATION: *OMB Number:* OMB 0412-NEW. *Form Number:* N/A. *Title:* Partner Information Form. *Type of Submission:* New Information Collection. *Purpose:* The United States Agency for International Development (USAID). Office of Security, intends to collect information from approximately 2000 individuals and/or officers of non-governmental organizations
(NGOs)who apply for USAID contracts, grants, cooperative agreements, other funding from USAID, or who apply for registration with USAID as Private and Voluntary Organizations (PVO). Collection of personally identifiable information from these individuals is specifically used to conduct screening to ensure that neither USAID funds nor USAID-funded activities inadvertently provide support to entities or individuals associated with terrorism. Annual Reporting Burden *Respondents:* 2000. *Total annual responses:* 2000. *Total annual hours requested:* 500 hours. Dated: November 27, 2007. Joanne Paskar, Chief, Information and Records Division Office of Administrative Services Bureau for Management. [FR Doc. 07-5935 Filed 12-4-07; 8:45 am]
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86 references not yet in our index
  • 7 CFR 905
  • 7 USC 601-674
  • 14 CFR 11
  • 14 CFR 13
  • 14 CFR 17
  • 14 CFR 36
  • 14 CFR 91
  • 14 CFR 139
  • 14 CFR 150
  • 14 CFR 193
  • 14 CFR 404
  • 14 CFR 406
  • 49 CFR 1.47
  • 5 USC 570-581
  • Pub. L. 96-193
  • 94 Stat. 50
  • 61 Stat. 1180
  • 1 CFR 51
  • 49 USC 70101-70121
  • 21 CFR 520.309
  • 21 CFR 20
  • 5 USC 801-808
  • 21 CFR 510
  • 21 CFR 520
  • 21 CFR 558
  • 23 CFR 630
  • Pub. L. 109-59
  • 119 Stat. 1227
  • 5 USC 601-612
  • Pub. L. 104-4
  • 109 Stat. 48
  • 49 CFR 1.48(b)
  • 49 CFR 7
  • 25 CFR 36
  • Pub. L. 107-110
  • 25 CFR 39
  • 115 Stat. 1425
  • 29 CFR 102
  • 451 F. Supp. 2d 57
  • 15 CFR 410(a)
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U.S.C.§ 6002
U.S.C.§ 2461
U.S.C.§ 4321
F. Supp.451 F. Supp. 2d 57
F. App'x372 F.3d 404
Cite7 CFR 905
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