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Code · REGISTER · 2007-01-19 · Agricultural Agricultural Research Service NOTICES Patent licenses; non-exclusive, exclusive, or partially exclusive: General Chemical Performance Products, LLC, 2490 E7-675 Agriculture Agriculture De · Unknown

Unknown. Final rule

46,160 words·~210 min read·/register/2007/01/19/07-231

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

--- schema: federal-register doc_type: fedreg source_file: FR-2007-01-19.xml --- 72 12 Friday, January 19, 2007 Contents Agricultural Agricultural Research Service NOTICES Patent licenses; non-exclusive, exclusive, or partially exclusive: General Chemical Performance Products, LLC, 2490 E7-675 Agriculture Agriculture Department See Agricultural Research Service See Forest Service Arts Arts and Humanities, National Foundation See National Foundation on the Arts and the Humanities Blind Blind or Severely Disabled, Committee for Purchase From People Who Are See Committee for Purchase From People Who Are Blind or Severely Disabled Centers Centers for Disease Control and Prevention NOTICES Agency information collection activities; proposals, submissions, and approvals, 2528-2530 E7-704 E7-705 Meetings:
Breast and Cervical Cancer Early Detection and Control Advisory Committee, 2530 E7-721 Clinical Laboratory Improvement Advisory Committee, 2530-2531 E7-720 National Center for Environmental Health/Agency for Toxic Substances and Disease Registry— Scientific Counselors Board, 2531 E7-707 Centers Centers for Medicare & Medicaid Services NOTICES Agency information collection activities; proposals, submissions, and approvals, E7-604 2531-2533 E7-700 07-154 Coast Guard Coast Guard RULES Ports and waterways safety; regulated navigation areas, safety zones, security zones, etc.:
Savannah River, GA, 2448-2454 E7-728 NOTICES Meetings: Ballast water management reporting requirements; revision, 2536-2537 E7-680 Chemical Transportation Advisory Committee, 2537 E7-679 Commerce Commerce Department See Industry and Security Bureau See International Trade Administration See National Oceanic and Atmospheric Administration Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement list; additions and deletions, 2491-2492 E7-716 E7-717 Commodity Commodity Futures Trading Commission NOTICES Meetings;
Sunshine Act, 2495-2496 07-225 07-226 07-227 07-228 Comptroller Comptroller of the Currency NOTICES Agency information collection activities; proposals, submissions, and approvals, 2592-2593 07-212 Consumer Consumer Product Safety Commission NOTICES Settlement agreements: Nexgrill Industries, Inc., 2496-2497 07-214 Customs Customs and Border Protection Bureau RULES Automated Commercial Environment Truck Manifest System; advance electronic truck cargo information requirement, 2435-2436 E7-762 Defense Defense Department RULES Civilian health and medical program of the uniformed services (CHAMPUS):
TRICARE program— Survivors of deceased active duty members and adoption intermediaries, 2444-2448 E7-709 Education Education Department NOTICES Grants and cooperative agreements; availability, etc.: Elementary and secondary education— Alaska Native Education Program, 2497-2501 E7-683 Indian education programs— Indian Education Formula Grant Program, 2501-2502 E7-760 Energy Energy Department See Federal Energy Regulatory Commission See Western Area Power Administration NOTICES Electricity export and import authorizations, permits, etc.:
Tenaska Power Services Co., 2503 E7-701 EPA Environmental Protection Agency RULES Grants and agreements: Nonprocurement debarment and suspension; OMB guidance; implementation, 2421-2427 E7-641 Superfund program: National oil and hazardous substances contingency plan priorities list, 2454-2458 E7-694 PROPOSED RULES Superfund program: National oil and hazardous substances contingency plan priorities list, 2484-2485 E7-693 NOTICES Agency information collection activities; proposals, submissions, and approvals, 2509-2511 E7-696 E7-698 Environmental statements; availability, etc.:
Agency comment availability, 2511-2512 E7-697 Agency weekly receipts, 2512-2513 E7-695 Superfund; response and remedial actions, proposed settlements, etc.: Bountiful 5 Points PCE Plume Site, UT, 2513 07-202 Toxic and hazardous substances control: New chemicals; receipt and status information, 2513-2517 E7-637 FAA Federal Aviation Administration PROPOSED RULES Airworthiness directives: Airbus, 2464-2475 E7-702 E7-715 Boeing, 2475-2480 E7-708 NOTICES Committees; establishment, renewal, termination, etc.:
National Parks Overflights Advisory Group Aviation Rulemaking Committee, 2582 07-186 FCC Federal Communications Commission PROPOSED RULES Television broadcasting: Advanced television
(ATV)systems— Digital television transition; DTV table of allotments; tentative channel designations, 2485-2487 E7-722 Federal Emergency Federal Emergency Management Agency NOTICES Agency information collection activities; proposals, submissions, and approvals, 2537-2538 E7-674 Federal Energy Federal Energy Regulatory Commission RULES Standards of conduct: Natural gas pipeline transmission providers, 2427-2435 E7-659 NOTICES Electric rate and corporate regulation combined filings, 2506-2507 E7-667 *Applications, hearings, determinations, etc.:* Bonneville Power Administration, 2503-2504 E7-666 City of Rocky Mount, NC, 2504 E7-660 City of Vernon, California, 2504-2505 E7-662 DTE Pontiac North LLC, 2505 E7-663 Occidental Power Services, Inc., 2505 E7-664 Sara Lee Bakery Goods, 2505-2506 E7-665 Southwestern Power Administration, 2506 E7-661 Federal Highway Federal Highway Administration NOTICES Environmental statements; notice of intent: Mecklenburg and Union Counties, NC, 2582-2583 07-196 Federal Mine Federal Mine Safety and Health Review Commission NOTICES Meetings; Sunshine Act, 2517 07-230 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies: Formations, acquisitions, and mergers, 2518 E7-642 Reports and guidance documents; availability, etc.: Payments system risk— Payments and settlement systems risk management; policy statement, 2518-2527 E7-589 Federal Retirement Federal Retirement Thrift Investment Board NOTICES Meetings; Sunshine Act, 2527-2528 07-220 Federal Transit Federal Transit Administration NOTICES Grants and cooperative agreements; availability, etc.: Public-Private Partnership Pilot Program, 2583-2591 E7-651 Fish Fish and Wildlife Service NOTICES Endangered and threatened species permit applications, 2538-2541 E7-745 E7-747 E7-749 Marine mammal permit applications, determinations, etc., E7-746 2541-2542 E7-750 Meetings: Service Regulations Committee, 2542 E7-753 Reports and guidance documents; availability, etc.: Native American Graves Protection and Repatriation Act; feathered headdress possession, 2542-2543 E7-759 Food Food and Drug Administration RULES Medical devices: Gloves; patient examination and surgeon's gloves; test procedures and acceptance criteria Correction, 2436-2444 E7-682 NOTICES Agency information collection activities; proposals, submissions, and approvals, 2533-2535 E7-681 Forest Forest Service NOTICES Environmental statements; availability, etc.: Tongass National Forest, AK, 2490 07-200 Recreation fee areas: Tonto National Forest, AZ; campgrounds, overnight rental fees, 2490-2491 07-204 Health Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Food and Drug Administration NOTICES *Special Exposure Cohort; employee class designations:* Hanford Nuclear Reservation, WA, 2528 07-194 Homeland Homeland Security Department See Coast Guard See Customs and Border Protection Bureau See Federal Emergency Management Agency See Transportation Security Administration NOTICES Secure Fence Act of 2006: Arizona; construction of physical barriers and roads along U.S. international land border; legal requirements waiver; secretarial determination, 2535-2536 E7-738 Housing Housing and Urban Development Department NOTICES Grants and cooperative agreements; availability, etc.: Homeless assistance; excess and surplus Federal properties, 2538 07-140 Indian Indian Affairs Bureau NOTICES Agency information collection activities; proposals, submissions, and approvals, 2543-2544 E7-758 Environmental statements; availability, etc.: Oneida Indian Nation of New York; fee-to-trust land transfer, public hearing, 2544 E7-743 Liquor and tobacco sale or distribution ordinance: Pokagon Band of Potawatomi Indians, MI, 2545-2550 E7-714 Meetings: Exceptional Children Advisory Board, 2550-2551 E7-744 Industry Industry and Security Bureau NOTICES Meetings: Materials Technical Advisory Committee, 2492 07-210 Interior Interior Department See Fish and Wildlife Service See Indian Affairs Bureau See Land Management Bureau See National Park Service International International Trade Administration NOTICES Antidumping: Silicon metal from— Brazil, 2492-2493 E7-726 North American Free Trade Agreement (NAFTA); binational panel reviews: Oil country tubular goods from— Mexico, 2493 E7-727 International International Trade Commission NOTICES Import investigations: Canned pineapple fruit from— Thailand, 2553-2554 E7-718 Clad steel plate from— Japan, 2554 E7-669 Coupler devices for power supply facilities, components and products containing same, 2554-2556 E7-670 Hot-rolled steel products from— Various countries, 2556-2557 E7-672 NAND flash memory devices and products containing same, 2557-2558 E7-673 Pasta from— Italy and Turkey, 2558 E7-719 Labor Labor Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 2559-2560 E7-678 Land Land Management Bureau NOTICES Meetings: Resource Advisory Councils— Utah, 2551 E7-741 Survey plat filings: New Mexico, 2551 07-203 Mine Mine Safety and Health Federal Review Commission See Federal Mine Safety and Health Review Commission National Foundation National Foundation on the Arts and the Humanities NOTICES Agency information collection activities; proposals, submissions, and approvals, 2560 E7-724 National Highway National Highway Traffic Safety Administration PROPOSED RULES Motor vehicle safety standards: Buses manufactured in two or more stages; identification requirements, 2487-2488 E7-654 NOAA National Oceanic and Atmospheric Administration RULES Fishery conservation and management: Alaska; fisheries of Exclusive Economic Zone— Pollock, 2462-2463 07-211 Northeastern United States fisheries— Summer flounder, 2458-2462 07-231 NOTICES Endangered and threatened species: Recovery plans— Puget Sound chinook salmon, 2493-2495 E7-810 National Park National Park Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 2551-2553 07-205 Nuclear Nuclear Regulatory Commission PROPOSED RULES Rulemaking petitions: Massachusetts Attorney General, 2464 E7-712 NOTICES Export and import license applications for nuclear facilities and materials: AREVA NP Inc., 2562-2563 E7-713 *Applications, hearings, determinations, etc.:* Nebraska Public Power District, 2560-2562 E7-699 Research Research and Innovative Technology Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 2591 E7-711 SEC Securities and Exchange Commission NOTICES Securities: Suspension of trading— Forest Resources Management Corp., 2563 07-229 Self-regulatory organizations; proposed rule changes: American Stock Exchange LLC, 2563-2566 E7-690 Depository Trust Co., 2566-2567 E7-692 International Securities Exchange, LLC, 2567-2568 E7-691 National Association of Securities Dealers, Inc., 2568-2577 E7-688 E7-689 New York Stock Exchange, LLC, 2577-2578 07-139 NYSE Arca, Inc., 2578-2581 E7-754 Selective Selective Service System NOTICES Senior Executive Service Performance Review Board; membership, 2581 07-208 State State Department NOTICES Meetings: International Law Advisory Committee, 2581 E7-828 Surface Surface Transportation Board NOTICES Meetings: Rail carriers; cost-of-capital determinations; methodology, 2591-2592 E7-655 Transportation Transportation Department See Federal Aviation Administration See Federal Highway Administration See Federal Transit Administration See National Highway Traffic Safety Administration See Research and Innovative Technology Administration See Surface Transportation Board Transportation Transportation Security Administration PROPOSED RULES Rail transportation security; sensitive security information protection; public meeting and comment request, 2488-2489 E7-671 Treasury Treasury Department See Comptroller of the Currency Veterans Veterans Affairs Department PROPOSED RULES National cemeteries: Headstone and marker application process, 2480-2484 E7-644 Western Western Area Power Administration NOTICES Environmental statement; notice of intent: Eastern Plains Transmission Project, CO and KS; public meetings, 2507-2509 E7-703 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 12 Friday, January 19, 2007 Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 2 CFR Part 1532 40 CFR Parts 26, 30, 32, 35, 36, 46 and 80 48 CFR Part 1509 [FRL-8270-5] RIN 2030-AA94 Environmental Protection Agency Implementation of OMB Guidance on Nonprocurement Debarment and Suspension AGENCY: Environmental Protection Agency. ACTION: Final rule. SUMMARY: The Environmental Protection Agency
(EPA)is publishing a new regulation on nonprocurement debarment and suspension in Title 2 of the Code of Federal Regulations
(CFR)as the final step of a four step process in streamlining the government-wide nonprocurement suspension and debarment rules. The purpose of this government-wide initiative is to make the rule on nonprocurement suspension and debarment easier to find and use by the regulated community. The first step in this process was the update to the nonprocurement suspension and debarment common rule published in the **Federal Register** on November 26, 2003. The second step was the establishment of Title 2 in the Code of Federal Regulations on May 11, 2004. The third step was the publication of the Office of Management and Budget's
(OMB)guidance on nonprocurement suspension and debarment as adoptable guidance of the new 2 CFR on August 31, 2005. This rule adopts OMB guidance on nonprocurement debarment and suspension. The EPA is also removing a regulation containing the existing EPA implementation of the government-wide common rule on nonprocurement debarment and suspension. This regulatory action makes no substantive change in EPA policy or procedures for nonprocurement debarment and suspension. DATES: The effective date for this final rule is February 20, 2007. FOR FURTHER INFORMATION CONTACT: Suzanne Hersh, Office of Grants and Debarment (3901R), Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, by phone
(202)564-5374 or by e-mail ( *hersh.suzanne@epa.gov* ). SUPPLEMENTARY INFORMATION: Background On May 11, 2004, OMB established Title 2 of the CFR with two subtitles (69 FR 26275). Subtitle A, “Government-wide Grants and Agreements,” contains OMB policy guidance to Federal agencies on grants and agreements. Subtitle B, “Federal Agency Regulations for Grants and Agreements,” contains Federal agencies' regulations implementing the OMB guidance, as it applies to grants and other financial assistance agreements and nonprocurement transactions. On August 31, 2005, the OMB published interim final guidance for government-wide nonprocurement debarment and suspension in the **Federal Register** (70 FR 51863). The guidance is located in title 2 of the CFR as new subtitle A, chapter 1, Part 180. The interim final guidance updated previous OMB guidance that was issued pursuant to Executive Order 12549, “Debarment and Suspension” (February 18, 1986), which gave government-wide effect to each agency's nonprocurement debarment and suspension actions. Section 6 of the Executive Order authorized OMB to issue guidance to Executive agencies on nonprocurement debarment and suspension, including provisions prescribing government-wide criteria and minimum due process. Section 3 directed Executive agencies to issue regulations implementing the Executive Order that are consistent with the OMB guidelines. On November 15, 2006, OMB published a final rule adopting the interim final guidance with changes (71 FR 66431). In accordance with OMB's guidance, the EPA issues this final rule to adopt and implement Title 2 CFR, Part 180 with the same additions and clarifications that EPA made to the common rule on nonprocurement debarment and suspension in November 2003 (68 FR 66533). Executive Order 12866 The OMB has determined this rule nonsignificant. Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)) This regulatory action will not have a significant adverse impact on a substantial number of small entities. Unfunded Mandates Act of 1995 (Sec. 202, Pub. L. 104-4) This regulatory action does not contain a Federal mandate that will result in the expenditure by State, local, and tribal governments, in aggregate, or by the private sector of $100 million or more in any one year. Paperwork Reduction Act of 1995 (44 U.S.C., Chapter 35) This regulatory action will not impose any additional reporting or recordkeeping requirements under the Paperwork Reduction Act. Federalism (Executive Order 13132) This regulatory action does not have Federalism implications, as set forth in Executive Order 13132. 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. Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments) Executive Order 13175, entitled “Consultation and Coordination With Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This final rule does not have tribal implications, as specified in Executive Order 13175. Executive Order 13211 (Energy Effects) This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not a significant regulatory action under Executive Order 12866. Congressional Review Act (5 U.S.C. 801, 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. 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). This rule will be effective 30 days from the date of publication in the **Federal Register** . List of Subjects 2 CFR Part 1532 Administrative practice and procedure, Air pollution control, Debarment and suspension, Environmental protection, Government contracts, Grant programs, Loan programs, Reporting and recordkeeping requirements, Technical assistance, Water pollution control. 40 CFR Part 26 Human research subjects, Report and recordkeeping requirements. 40 CFR Part 30 Accounting, Colleges and universities, Grant programs, Hospitals, Nonprofit organizations, Reporting and recordkeeping requirements. 40 CFR Part 32 Administrative practice and procedure, Air pollution control, Debarment and suspension, Environmental protection, Government contracts, Grant programs, Loan programs, Reporting and recordkeeping requirements, Technical assistance, Water pollution control. 40 CFR Part 35 Air pollution control, Coastal zone, Grant programs—environmental protection, Grant programs—Indians, Hazardous waste, Indians, Intergovernmental relations, Pesticides and pests, Reporting and recordkeeping requirements, Technical assistance, Waste treatment and disposal, Water pollution control, Water Supply. 40 CFR Part 36 Administrative practice and procedure, Drug abuse, Grant programs, Loan programs, Reporting and recordkeeping requirements. 40 CFR Part 46 Environmental protection, Grant programs—education, Grant programs—environmental protection, Reporting and recordkeeping requirements, scholarships and fellowships. 40 CFR Part 80 Fuel additives, Gasoline, Imports, Labeling, Motor vehicle pollution, Penalties, Reporting and recordkeeping requirements. 48 CFR Part 1509 Government procurement, Reporting and recordkeeping requirements. Dated: January 8, 2007. Howard Corcoran, Director, Office of Grants and Debarment, U.S. Environmental Protection Agency. For the reasons stated in the preamble, the Environmental Protection Agency amends title 2, subtitle B; title 40, chapter I; and title 48, chapter XV, of the Code of Federal Regulations as follows: Title 2—Grants and Agreements 1. Add Chapter 15, consisting of Part 1532 to Subtitle B to read as follows: Chapter 15—Environmental Protection Agency PART 1532—NONPROCUREMENT DEBARMENT AND SUSPENSION Sec. 1532.10 What does this part do? 1532.20 Does this part apply to me? 1532.30 What policies and procedures must I follow? Subpart A—General 1532.137 Who in the EPA may grant an exception to let an excluded person participate in a covered transaction? Subpart B—Covered Transactions 1532.220 What contracts and subcontracts, in addition to those listed in 2 CFR 180.220, are covered transactions? Subpart C—Responsibilities of Participants Regarding Transactions 1532.332 What methods must I use to pass requirements down to participants at lower tiers with whom I intend to do business? Subpart D—Responsibilities of Federal Agency Officials Regarding Transactions 1532.437 What method do I use to communicate to a participant the requirements described in the OMB guidance at 2 CFR 180.435? Subparts E through F—[Reserved] Subpart G—Suspension 1532.765 How may I appeal my EPA suspension? Subpart H—Debarment 1532.890 How may I appeal my EPA debarment? Subpart I—Definitions 1532.995 Principal (EPA supplement to government-wide definition at 2 CFR 180.995). Subpart J—Statutory Disqualification and Reinstatement Under the Clean Air Act and Clean Water Act 1532.1100 What does this subpart do? 1532.1105 Does this subpart apply to me? 1532.1110 How will a CAA or CWA conviction affect my eligibility to participate in Federal contracts, subcontracts, assistance, loans and other benefits? 1532.1115 Can the EPA extend a CAA or CWA disqualification to other facilities? 1532.1120 What is the purpose of CAA or CWA disqualification? 1532.1125 How do award officials and others know if I am disqualified? 1532.1130 How does disqualification under the CAA or CWA differ from a Federal discretionary suspension or debarment action? 1532.1135 Does CAA or CWA disqualification mean that I must remain ineligible? 1532.1140 Can an exception be made to allow me to receive an award even though I may be disqualified? 1532.1200 How will I know if I am disqualified under the CAA or CWA? 1532.1205 What procedures must I follow to have my procurement and nonprocurement eligibility reinstated under the CAA or CWA? 1532.1210 Will anyone else provide information to the EPA debarring official concerning my reinstatement request? 1532.1215 What happens if I disagree with the information provided by others to the EPA debarring official on my reinstatement request? 1532.1220 What will the EPA debarring official consider in making a decision on my reinstatement request? 1532.1225 When will the EPA debarring official make a decision on my reinstatement request? 1532.1230 How will the EPA debarring official notify me of the reinstatement decision? 1532.1300 Can I resolve my eligibility status under terms of an administrative agreement without having to submit a formal reinstatement request? 1532.1305 What are the consequences if I mislead the EPA in seeking reinstatement or fail to comply with my administrative agreement? 1532.1400 How may I appeal a decision denying my request for reinstatement? 1532.1500 If I am reinstated, when will my name be removed from the EPLS? 1532.1600 What definitions apply specifically to actions under this subpart? Authority: 33 U.S.C. 1251 *et seq.* ; 42 U.S.C. 7401 *et seq.* ; Sec. 2455, Pub. L. 103-355, 108 Stat. 3327 (31 U.S.C. 6101 note); E.O. 11738 (3 CFR, 1973 Comp., p. 799); E.O. 12549 (3 CFR, 1986 Comp., p. 189); E.O. 12689 (3 CFR, 1989 Comp., p. 235). § 1532.10 What does this part do? This part adopts the Office of Management and Budget
(OMB)guidance in subparts A through I of 2 CFR part 180, as supplemented by this part, as the Environmental Protection Agency
(EPA)policies and procedures for nonprocurement debarment and suspension. It thereby gives regulatory effect for the EPA to the OMB guidance as supplemented by this part. This part satisfies the requirements in section 3 of Executive Order 12549, “Debarment and Suspension” (3 CFR 1986 Comp., p. 189), Executive Order 12689, “Debarment and Suspension” (3 CFR 1989 Comp., p. 235) and 31 U.S.C. 6101 note (Section 2455, Pub. L. 103-355, 108 Stat. 3327). § 1532.20 Does this part apply to me? This part and, through this part, pertinent portions of the OMB guidance in Subparts A through I of 2 CFR part 180 (see table at 2 CFR 180.100(b)) apply to you if you are a—
(a)Participant or principal in a “covered transaction” (see subpart B of 2 CFR part 180 and the definition of “nonprocurement transaction” at 2 CFR 180.970;
(b)Respondent in an EPA suspension or debarment action;
(c)EPA debarment or suspension official; or
(d)EPA grants officer, agreements officer, or other official authorized to enter into any type of nonprocurement transaction that is a covered transaction. § 1532.30 What policies and procedures must I follow? The EPA policies and procedures that you must follow are the policies and procedures specified in each applicable section of the OMB guidance in subparts A through I of 2 CFR part 180, as that section is supplemented by the section in this part with the same section number. The contracts that are covered transactions, for example, are specified by section 220 of the OMB guidance (i.e., 2 CFR 180.220) as supplemented by section 220 in this part (i.e., § 1532.220). For any section of OMB guidance in subparts A through I of 2 CFR 180 that has no corresponding section in this part, EPA policies and procedures are those in the OMB guidance. Subpart A—General § 1532.137 Who in the EPA may grant an exception to let an excluded person participate in a covered transaction? The EPA Debarring Official has the authority to grant an exception to let an excluded person participate in a covered transaction, as provided in the OMB guidance at 2 CFR 180.135. If the EPA Debarring Official grants an exception, the exception must be in writing and state the reason(s) for deviating from the governmentwide policy in Executive Order 12549. Subpart B—Covered Transactions § 1532.220 What contracts and subcontracts, in addition to those listed in 2 CFR 180.220, are covered transactions? In addition to the contracts covered under 2 CFR 180.220(b) of the OMB guidance, this part applies to any contract, regardless of tier, that is awarded by a contractor, subcontractor, supplier, consultant, or its agent or representative in any transaction, if the contract is to be funded or provided by the EPA under a covered nonprocurement transaction and the amount of the contract is expected to equal or exceed $25,000. This extends the coverage of the EPA nonprocurement suspension and debarment requirements to all lower tiers of subcontracts under covered nonprocurement transactions, as permitted under the OMB guidance at 2 CFR 180.220(c) (see optional lower tier coverage in the figure in the appendix to 2 CFR part 180). Subpart C—Responsibilities of Participants Regarding Transactions § 1532.332 What methods must I use to pass requirements down to participants at lower tiers with whom I intend to do business? You as a participant must include a term or condition in lower-tier transactions requiring lower-tier participants to comply with subpart C of the OMB guidance in 2 CFR part 180, as supplemented by this subpart. Subpart D—Responsibilities of Federal Agency Officials Regarding Transactions § 1532.437 What method do I use to communicate to a participant the requirements described in the OMB guidance at 2 CFR 180.435? To communicate to a participant the requirements described in 2 CFR 180.435 of the OMB guidance, you must include a term or condition in the transaction that requires the participant's compliance with subpart C of 2 CFR part 180, as supplemented by subpart C of this part, and requires the participant to include a similar term or condition in lower-tier covered transactions. Subpart E through F—[Reserved] Subpart G—Suspension § 1532.765 How may I appeal my EPA suspension?
(a)If the EPA suspending official issues a decision under 2 CFR 180.755 to continue your suspension after you present information in opposition to that suspension under 2 CFR 180.720, you can ask for review of the suspending official's decision in two ways:
(1)You may ask the suspending official to reconsider the decision for material errors of fact or law that you believe will change the outcome of the matter; and/or
(2)You may request the Director, Office of Grants and Debarment (OGD Director), to review the suspending official's decision to continue your suspension within 30 days of your receipt of the suspending official's decision under 2 CFR 180.755 or paragraph (a)(1) of this section. However, the OGD Director can reverse the suspending official's decision only where the OGD Director finds that the decision is based on a clear error of material fact or law, or where the OGD Director finds that the suspending official's decision was arbitrary, capricious, or an abuse of discretion.
(b)A request for review under this section must be in writing; state the specific findings you believe to be in error; and include the reasons or legal bases for your position.
(c)A review under paragraph (a)(2) of this section is solely within the discretion of the OGD Director who may also stay the suspension pending review of the suspending official's decision.
(d)The EPA suspending official and the OGD Director must notify you of their decisions under this section, in writing, using the notice procedures at 2 CFR 180.615 and 180.975. Subpart H—Debarment § 1532.890 How may I appeal my EPA debarment?
(a)If the EPA debarring official issues a decision under 2 CFR 180.870 to debar you after you present information in opposition to a proposed debarment under 2 CFR 180.815, you can ask for review of the debarring official's decision in two ways:
(1)You may ask the debarring official to reconsider the decision for material errors of fact or law that you believe will change the outcome of the matter; and/or
(2)You may request the Director, Office of Grants and Debarment (OGD Director), to review the debarring official's decision to debar you within 30 days of your receipt of the debarring official's decision under 2 CFR 180.870 or paragraph (a)(1) of this section. However, the OGD Director can reverse the debarring official's decision only where the OGD Director finds that the decision is based on a clear error of material fact or law, or where the OGD Director finds that the debarring official's decision was arbitrary, capricious, or an abuse of discretion.
(b)A request for review under this section must be in writing; state the specific findings you believe to be in error; and include the reasons or legal bases for your position.
(c)A review under paragraph (a)(2) of this section is solely within the discretion of the OGD Director who may also stay the debarment pending review of the debarring official's decision.
(d)The EPA debarring official and the OGD Director must notify you of their decisions under this section, in writing, using the notice procedures at 2 CFR 180.615 and 180.975. Subpart I—Definitions § 1532.995 Principal (EPA supplement to government-wide definition at 2 CFR 180.995). In addition to those listed in 2 CFR 180.995, other examples of individuals who are principals in EPA covered transactions include:
(a)Principal investigators;
(b)Technical or management consultants;
(c)Individuals performing chemical or scientific analysis or oversight;
(d)Professional service providers such as doctors, lawyers, accountants, engineers, etc.;
(e)Individuals responsible for the inspection, sale, removal, transportation, storage or disposal of solid or hazardous waste or materials;
(f)Individuals whose duties require special licenses;
(g)Individuals that certify, authenticate or authorize billings; and
(h)Individuals that serve in positions of public trust. Subpart J—Statutory Disqualification and Reinstatement Under the Clean Air Act and Clean Water Act § 1532.1100 What does this subpart do? This subpart explains how the EPA administers section 306 of the Clean Air Act
(CAA)(42 U.S.C. 7606) and section 508 of the Clean Water Act
(CWA)(33 U.S.C. 1368), which disqualify persons convicted for certain offenses under those statutes (see § 1532.1105), from eligibility to receive certain contracts, subcontracts, assistance, loans and other benefits (see coverage under the Federal Acquisition Regulation (FAR), 48 CFR part 9, subpart 9.4 and subparts A through I of 2 CFR part 180). It also explains: the procedures for seeking reinstatement of a person's eligibility under the CAA or CWA; the criteria and standards that apply to EPA's decision-making process; and requirements of award officials and others involved in Federal procurement and nonprocurement activities in carrying out their responsibilities under the CAA and CWA. § 1532.1105 Does this subpart apply to me?
(a)Portions of this subpart apply to you if you are convicted, or likely to be convicted, of any offense under section 7413(c) of the CAA or section 1319(c) of the CWA.
(b)Portions of this subpart apply to you if you are the EPA debarring official, a Federal procurement or nonprocurement award official, a participant in a Federal procurement or nonprocurement program that is precluded from entering into a covered transaction with a person disqualified under the CAA or CWA, or if you are a Federal department or agency anticipating issuing an exception to a person otherwise disqualified under the CAA or CWA. § 1532.1110 How will a CAA or CWA conviction affect my eligibility to participate in Federal contracts, subcontracts, assistance, loans and other benefits? If you are convicted of any offense described in § 1532.1105, you are automatically disqualified from eligibility to receive any contract, subcontract, assistance, sub-assistance, loan or other nonprocurement benefit or transaction that is prohibited by a Federal department or agency under the Governmentwide debarment and suspension system (i.e. covered transactions under subpart A through I of 2 CFR part 180, or prohibited awards under 48 CFR part 9, subpart 9.4), if you:
(a)Will perform any part of the transaction or award at the facility giving rise to your conviction (called the violating facility); and
(b)You own, lease or supervise the violating facility. § 1532.1115 Can the EPA extend a CAA or CWA disqualification to other facilities? The CAA specifically authorizes the EPA to extend a CAA disqualification to other facilities that are owned or operated by the convicted person. The EPA also has authority under subparts A through I of 2 CFR part 180, or under 48 CFR part 9, subpart 9.4, to take discretionary suspension and debarment actions on the basis of misconduct leading to a CAA or CWA conviction, or for activities that the EPA debarring official believes were designed to improperly circumvent a CAA or CWA disqualification. § 1532.1120 What is the purpose of CAA or CWA disqualification? As provided for in Executive Order 11738 (3 CFR, 1973 Comp., p. 799), the purpose of CAA and CWA disqualification is to enforce the Federal Government's policy of undertaking Federal procurement and nonprocurement activities in a manner that improves and enhances environmental quality by promoting effective enforcement of the CAA or CWA. § 1532.1125 How do award officials and others know if I am disqualified? If you are convicted under these statutes, the EPA enters your name and address and that of the violating facility into the Excluded Parties List System
(EPLS)as soon as possible after the EPA learns of your conviction. In addition, the EPA enters other information describing the nature of your disqualification. Federal award officials and others who administer Federal programs consult the EPLS before entering into or approving procurement and nonprocurement transactions. Anyone may access the EPLS through the internet, currently at *http://www.epls.gov.* § 1532.1130 How does disqualification under the CAA or CWA differ from a Federal discretionary suspension or debarment action?
(a)CAA and CWA disqualifications are exclusions mandated by statute. In contrast, suspensions and debarments imposed under subparts A through I of 2 CFR part 180 or under 48 CFR part 9, subpart 9.4, are exclusions imposed at the discretion of Federal suspending or debarring officials. This means that if you are convicted of violating the CAA or CWA provisions described under § 1532.1105, ordinarily your name and that of the violating facility is placed into the EPLS before you receive a confirmation notice of the listing, or have the opportunity to discuss the disqualification with, or seek reinstatement from, the EPA.
(b)CAA or CWA disqualification applies to both the person convicted of the offense, and to the violating facility during performance of an award or covered transaction under the Federal procurement and nonprocurement suspension and debarment system. It is the EPA's policy to carry out CAA and CWA disqualifications in a manner which integrates the disqualifications into the Governmentwide suspension and debarment system. Whenever the EPA determines that the risk presented to Federal procurement and nonprocurement activities on the basis of the misconduct which gives rise to a person's CAA or CWA conviction exceeds the coverage afforded by mandatory disqualification, the EPA may use its discretionary authority to suspend or debar a person under subparts A through I of 2 CFR part 180, or under 48 CFR part 9, subpart 9.4. § 1532.1135 Does CAA or CWA disqualification mean that I must remain ineligible? You must remain ineligible until the EPA debarring official certifies that the condition giving rise to your conviction has been corrected. If you desire to have your disqualification terminated, you must submit a written request for reinstatement to the EPA debarring official and support your request with persuasive documentation. For information about the process for reinstatement see §§ 1532.1205 and 1532.1300. § 1532.1140 Can an exception be made to allow me to receive an award even though I may be disqualified?
(a)After consulting with the EPA debarring official, the head of any Federal department or agency (or designee) may exempt any particular award or a class of awards with that department or agency from CAA or CWA disqualification. In the event an exemption is granted, the exemption must:
(1)Be in writing; and
(2)State why the exemption is in the paramount interests of the United States.
(b)In the event an exemption is granted, the exempting department or agency must send a copy of the exemption decision to the EPA debarring official for inclusion in the official record. § 1532.1200 How will I know if I am disqualified under the CAA or CWA? There may be several ways that you learn about your disqualification. You are legally on notice by the statutes that a criminal conviction the CAA or CWA automatically disqualifies you. As a practical matter, you may learn about your disqualification from your defense counsel, a Federal contract or award official, or from someone else who sees your name in the EPLS. As a courtesy, the EPA will attempt to notify you and the owner, lessor or supervisor of the violating facility that your names have been entered into the EPLS. The EPA will inform you of the procedures for seeking reinstatement and give you the name of a person you can contact to discuss your reinstatement request. § 1532.1205 What procedures must I follow to have my procurement and nonprocurement eligibility reinstated under the CAA or CWA?
(a)You must submit a written request for reinstatement to the EPA debarring official stating what you believe the conditions were that led to your conviction, and how those conditions have been corrected, relieved or addressed. Your request must include documentation sufficient to support all material assertions you make. The debarring official must determine that all the technical and non-technical causes, conditions and consequences of your actions have been sufficiently addressed so that the Government can confidently conduct future business activities with you, and that your future operations will be conducted in compliance with the CAA and CWA.
(b)You may begin the reinstatement process by having informal discussions with the EPA representative named in your notification of listing. Having informal dialogue with that person will make you aware of the EPA concerns that must be addressed. The EPA representative is not required to negotiate conditions for your reinstatement. However, beginning the reinstatement process with informal dialogue increases the chance of achieving a favorable outcome, and avoids unnecessary delay that may result from an incomplete or inadequate reinstatement request. It may also allow you to resolve your disqualification by reaching an agreement with the EPA debarring official under informal procedures. Using your informal option first does not prevent you from submitting a formal reinstatement request with the debarring official at any time. § 1532.1210 Will anyone else provide information to the EPA debarring official concerning my reinstatement request? If you request reinstatement under § 1532.1205, the EPA debarring official may obtain review and comment on your request by anyone who may have information about, or an official interest in, the matter. For example, the debarring official may consult with the EPA Regional offices, the Department of Justice or other Federal agencies, or state, tribal or local governments. The EPA debarring official will make sure that you have an opportunity to address important allegations or information contained in the administrative record before making a final decision on your request for reinstatement. § 1532.1215 What happens if I disagree with the information provided by others to the EPA debarring official on my reinstatement request?
(a)If your reinstatement request is based on factual information (as opposed to a legal matter or discretionary conclusion) that is different from the information provided by others or otherwise contained in the administrative record, the debarring official will decide whether those facts are genuinely in dispute, and material to making a decision. If so, a fact-finding proceeding will be conducted in accordance with 2 CFR 180.830 through 180.840, and the debarring official will consider the findings when making a decision on your reinstatement request.
(b)If the basis for your disagreement with the information contained in the administrative record relates to a legal issue or discretionary conclusion, or is not a genuine dispute over a material fact, you will not have a fact-finding proceeding. However, the debarring official will allow you ample opportunity to support your position for the record and present matters in opposition to your continued disqualification. A summary of any information you provide orally, if not already recorded, should also be submitted to the debarring official in writing to assure that it is preserved for the debarring official's consideration and the administrative record. § 1532.1220 What will the EPA debarring official consider in making a decision on my reinstatement request?
(a)The EPA debarring official will consider all information and arguments contained in the administrative record in support of, or in opposition to, your request for reinstatement, including any findings of material fact.
(b)The debarring official will also consider any mitigating or aggravating factors that may relate to your conviction or the circumstances surrounding it, including any of those factors that appear in 2 CFR 180.860 that may apply to your situation.
(c)Finally, if disqualification applies to a business entity, the debarring official will consider any corporate or business attitude, policies, practices and procedures that contributed to the events leading to conviction, or that may have been implemented since the date of the misconduct or conviction. You can obtain any current policy directives issued by the EPA that apply to CAA or CWA disqualification or reinstatement by contacting the Office of the EPA Debarring Official, U.S. EPA, Office of Grants and Debarment (3901R), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. § 1532.1225 When will the EPA debarring official make a decision on my reinstatement request?
(a)The EPA debarring official will make a decision regarding your reinstatement request under § 1532.1205(a), when the administrative record is complete, and he or she can determine whether the condition giving rise to the CAA or CWA conviction has been corrected-usually within 45 days of closing the administrative record.
(b)A reinstatement request is not officially before the debarring official while you are having informal discussions under § 1532.1205(b). § 1532.1230 How will the EPA debarring official notify me of the reinstatement decision? The EPA debarring official will notify you of the reinstatement decision in writing, using the same methods for communicating debarment or suspension action notices under 2 CFR 180.615. § 1532.1300 Can I resolve my eligibility status under terms of an administrative agreement without having to submit a formal reinstatement request?
(a)The EPA debarring official may, at any time, resolve your CAA or CWA eligibility status under the terms of an administrative agreement. Ordinarily, the debarring official will not make an offer to you for reinstatement until after the administrative record for decision is complete, or contains enough information to enable him or her to make an informed decision in the matter.
(b)Any resolution of your eligibility status under the CAA or CWA resulting from an administrative agreement must include a certification that the condition giving rise to the conviction has been corrected.
(c)The EPA debarring official may enter into an administrative agreement to resolve CAA or CWA disqualification issues as part of a comprehensive criminal plea, civil or administrative agreement when it is in the best interest of the United States to do so. § 1532.1305 What are the consequences if I mislead the EPA in seeking reinstatement or fail to comply with my administrative agreement?
(a)Any certification of correction issued by the EPA debarring official whether the certification results from a reinstatement decision under §§ 1532.1205(a) and 1532.1230, or from an administrative agreement under §§ 1532.1205(b) and 1532.1300, is conditioned upon the accuracy of the information, representations or assurances made during development of the administrative record.
(b)If the EPA debarring official finds that he or she has certified correction of the condition giving rise to a CAA or CWA conviction or violation on the basis of a false, misleading, incomplete or inaccurate information; or if a person fails to comply with material condition of an administrative agreement, the EPA debarring official may take suspension or debarment action against the person(s) responsible for the misinformation or noncompliance with the agreement as appropriate. If anyone provides false, inaccurate, incomplete or misleading information to EPA in an attempt to obtain reinstatement, the EPA debarring official will refer the matter to the EPA Office of Inspector General for potential criminal or civil action. § 1532.1400 How may I appeal a decision denying my request for reinstatement?
(a)If the EPA debarring official denies your request for reinstatement under the CAA or CWA, you can ask for review of the debarring official's decision in two ways:
(1)You may ask the debarring official to reconsider the decision for material errors of fact or law that you believe will change the outcome of the matter; and/ or
(2)You may request the Director, Office of Grants and Debarment (OGD Director), to review the debarring official's denial within 30 days of your receipt of the debarring official's decision under § 1532.1230 or paragraph (a)(1) of this section. However, the OGD Director can reverse the debarring official's decision denying reinstatement only where the OGD Director finds that there is a clear error of material fact or law, or where the OGD Director finds that the debarring official's decision was arbitrary, capricious, or an abuse of discretion.
(b)A request for review under this section must be in writing and state the specific findings you believe to be in error and include the reasons or legal bases for your position.
(c)A review under this section is solely within the discretion of the OGD Director.
(d)The OGD Director must notify you of his or her decision under this section, in writing, using the notice procedures at 2 CFR 180.615 and 180.975. § 1532.1500 If I am reinstated, when will my name be removed from the EPLS? If your eligibility for procurement and nonprocurement participation is restored under the CAA or CWA, whether by decision, appeal, or by administrative agreement, the EPA will remove your name and that of the violating facility from the EPLS, generally within 5 working days of your reinstatement. § 1532.1600 What definitions apply specifically to actions under this subpart? In addition to definitions under subpart A through I of 2 CFR part 180 that apply to this part as a whole, the following two definitions apply specifically to CAA and CWA disqualifications under this subpart:
(a)Person means an individual, corporation, partnership, association, state, municipality, commission, or political subdivision of a state, or any interstate body.
(b)Violating facility means any building, plant, installation, structure, mine, vessel, floating craft, location or site of operations that gives rise to a CAA or CWA conviction, and is a location at which or from which a Federal contract, subcontract, loan, assistance award or other covered transactions may be performed. If a site of operations giving rise to a CAA or CWA conviction contains or includes more than one building, plant, installation, structure, mine, vessel, floating craft, or other operational element, the entire location or site of operation is regarded as the violating facility unless otherwise limited by the EPA. Title 40 Environment—Chapter I—Environmental Protection Agency PART 26—[AMENDED] 1. The authority citation for part 26 continues to read as follows: Authority: 5 U.S.C. 301; 7 U.S.C. 163w(a)(1); 21 U.S.C. 346a(e)(1)(C); section 201 of Pub. L. 109-54; and 42 U.S.C. 300v-1(b). § 26.1506 [Amended] 2. Section 26.1506 is amended by revising the citation “40 CFR Part 32” to read “2 CFR part 1532.” PART 30—[AMENDED] 3. The authority citation for part 30 continues to read as follows: Authority: 7 U.S.C. 135 *et seq.* ; 15 U.S.C. 2601 *et seq.* ; 33 U.S.C. *et seq.* ; 42 U.S.C. 241, 242b, 243, 246, 300f, 300j-1, 300j-2, 300j-3, 1857 *et seq.* , 6901 *et seq.* , 7401 *et seq.* , 9601 *et seq.* ; OMB Circular A-110 (64 FR 54926, October 8, 1999). § 30.13 [Amended] 4. Section 30.13 is amended by revising twice the citation “40 CFR Part 32” to read “2 CFR part 1532.” Appendix to Part 30—[Amended] 5. Appendix to part 30 is amended by removing paragraph 8. PART 32—[REMOVED] 6. Under authority Sec. 2455, Pub. L. 103-355, 108 Stat. 3327 (31 U.S.C. 6101 note); E.O. 11738 (3 CFR, 1973 Comp., p. 799); E.O. 12549 (3 CFR, 1986 Comp., p. 189); E.O. 12689 (3 CFR, 1989 Comp., p. 235) part 32 is removed. PART 35—[AMENDED] 7. The authority citation for part 35 continues to read as follows: Authority: 42 U.S.C. 9601 *et seq.* § 35.6055 [Amended] 8. Section 35.6055 is amended by removing paragraphs(a)(3) and (a)(4) and redesignating paragraphs (a)(5) and (a)(6) as (a)(3) and (a)(4) respectively. § 35.6105 [Amended] 9. Section 35.6105 is amended by removing paragraphs(a)(3) and (a)(4) and redesignating paragraphs (a)(5) and (a)(6) as (a)(3) and (a)(4) respectively. PART 36—[AMENDED] 10. The authority citation for part 36 continues to read as follows: Authority: 41 U.S.C. 701 *et seq.* § 36.510 [Amended] 11. Section 36.510(c) is amended by revising the citation “40 CFR Part 32” to read “2 CFR part 1532.” PART 46—[AMENDED] 12. The authority citation for part 46 continues to read as follows: Authority: Section 103(b)(5) of the Clean Air Act, as amended (42 U.S.C. 7403(b)(5)); sections 104(b)(5) and (g)(3)(B) of the Clean Water Act, as amended (33 U.S.C. 1254(b)(5) and (g)(3)(B)); section 1442 of the Safe Drinking Water Act, as amended (42 U.S.C. 300j-1); section 8001 of the Solid Waste Disposal Act, as amended (42 U.S.C. 6981); section 10 of the Toxic Substances Control Act, as amended (15 U.S.C. 2609); section 20 of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. 136r); sections 104(k)(6)and 311 of the Comprehensive Environmental Response, Compensation, and Liability Act (42 U.S.C. 9604(k)(6) and 42 U.S.C. 9660). 13. Section 46.130 is amended by revising the second sentence to read as follows: § 46.130 Debarment and suspension. * * * Names of individuals who are excluded or disqualified are located in the Excluded Parties List System maintained by the General Services Administration and currently located at *http://www.epls.gov* . § 46.215 [Amended] 14. Section 46.215(c) is amended by revising the citation “40 CFR Part 32” to read “2 CFR part 1532.” PART 80—[AMENDED] 15. The authority citation for part 80 continues to read as follows: Authority: 42 U.S.C. 7414, 7545, 7542, and 7610(a). § 80.65 [Amended] 16. Section 80.65(f)(2)(iv) is amended by revising the citation “40 CFR Part 32” to read “2 CFR part 1532.” 17. Section 80.65(f)(2)(v) is amended by revising the citation “40 CFR Part 32” to read “2 CFR part 1532.” § 80.125 [Amended] 18. Section 80.125(e) is amended by revising the citation “40 CFR Part 32” to read “2 CFR part 1532.” Title 48 Federal Acquisition Regulations System—Chapter XV—Environmental Protection Agency PART 1509—[AMENDED] 19. The authority citation for part 1509 continues to read as follows: Authority: Sec. 205(c), 63 Stat. 390, as amended, 40 U.S.C. 486(c). 1509.403 [Amended] 20. Section 1509.403 is amended by revising the citation “40 CFR Part 32” to read “2 CFR part 1532.” [FR Doc. E7-641 Filed 1-18-07; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 18 CFR Part 358 [Docket No. RM07-6-000; Order No. 690] Standards of Conduct for Transmission Providers Issued January 9, 2007. AGENCY: Federal Energy Regulatory Commission, DOE. ACTION: Interim rule. SUMMARY: This interim rule responds to the decision of the United States Court of Appeals for the District of Columbia vacating and remanding the standards of conduct rule, Order No. 2004, as it relates to interstate natural gas pipelines, in *National Fuel Gas Supply Corporation* v. *FERC* , 468 F.3d 831 (D.C. Cir. 2006). The court objected to the Federal Energy Regulatory Commission's (Commission's) expansion of the prior standards of conduct to include energy affiliates, and vacated the entire rule as it relates to natural gas pipelines. The interim rule repromulgates the standards of conduct that were not challenged before the court on an interim basis while the Commission considers how to respond to the court's decision on a permanent basis. EFFECTIVE DATE: This rule is effective January 9, 2007. FOR FURTHER INFORMATION CONTACT: Deme Anas, Office of Enforcement, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. Telephone:
(202)502-8178. E-mail: *demetra.anas@ferc.gov* . Stuart Fischer, Office of Enforcement, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. Telephone:
(202)502-8517. E-mail: *stuart.fischer@ferc.gov* . SUPPLEMENTARY INFORMATION: Before Commissioners: Joseph T. Kelliher, Chairman; Suedeen G. Kelly, Marc Spitzer, Philip D. Moeller, and Jon Wellinghoff. I. Introduction 1. The Federal Energy Regulatory Commission (Commission) is promulgating interim standards of conduct regulations that govern the relationship between natural gas transmission providers and their marketing affiliates to respond to the decision of the United States Court of Appeals for the District of Columbia concerning the Standards of Conduct for Transmission Providers under Order No. 2004. 1 In *National Fuel Gas Supply Corporation* v. *FERC (National Fuel)* , 2 the court found that the Commission did not support the standards of conduct's expansive definition of energy affiliates and vacated Order Nos. 2004, 2004-A, 2004-B, 2004-C and 2004-D (collectively referred to as Order No. 2004) as applied to natural gas pipelines, and remanded the orders to the Commission. 3 Specifically, the court rejected the Commission's attempt to extend the standards of conduct beyond pipelines' relationships with their marketing affiliates to govern pipelines' relationships with numerous non-marketing affiliates, such as producers, gatherers, and local distribution companies (energy affiliates). In light of this finding, the court found moot the other issues raised on appeal. 4 1 On November 25, 2003, the Commission added Part 358 to the Commission's regulations adopting standards of conduct that apply uniformly to natural gas and electric utility transmission providers. *Standards of Conduct for Transmission Providers* , Order No. 2004, FERC Stats. & Regs., Regulations Preambles ¶ 31,155 (2003), *order on reh'g* , Order No. 2004-A, III FERC Stats. & Regs. ¶ 31,161 (2004), 107 FERC ¶ 61,032 (2004), *order on reh'g* , Order No. 2004-B, III FERC Stats. & Regs. ¶ 31,166 (2004), 108 FERC ¶ 61,118 (2004), *order on reh'g* , Order No. 2004-C, 109 FERC ¶ 61,325 (2004), *order on reh'g* , Order No. 2004-D, 110 FERC ¶ 61,320 (2005), vacated and *remanded as it applies to natural gas pipelines, National Fuel Gas Supply Corporation* v. *FERC* , 468 F.3d 831 (D.C. Cir. 2006). 2 *National Fuel* slip op. at 4 [published cite not yet available]. 3 *National Fuel* , slip op. at 4. Order No. 2004 was not appealed as it applies to electric utility transmission providers. 4 *National Fuel* , slip op. at 4. 2. The purpose of this order is to repromulgate the standards of conduct not challenged in the *National Fuel* appeal in the interim while the Commission considers how to respond to the court's decision on a permanent basis. To that end, the Commission plans to issue a Notice of Proposed Rulemaking
(NOPR)in the very near future. The interim rule will thus help eliminate any uncertainty about how the standards of conduct apply to natural gas transmission providers while the Commission develops a final rule. 3. The Commission believes that this interim rule is consistent with the court's decision in *National Fuel* and meets the standards for an interim rule without notice and comment under the Administrative Procedure Act as set out in the court's opinion in *Mid-Tex Electric Cooperative, Inc.* v. *FERC (Mid-Tex)* . 5 In *Mid-Tex* , the court reviewed the Commission's interim rule regarding the construction work in progress
(CWIP)accounts for electric utilities that had previously been vacated and remanded by the court. 6 Despite objections to the interim CWIP rule, the court upheld the interim rule as consistent with the letter and spirit of its previous ruling. 7 The court concluded that the Commission could reasonably infer that should it become necessary or proper to provide a regulation prior to its full reconsideration of the CWIP issue, it may do so if it addresses the issues raised by the court. 8 5 *Mid-Tex Electric Cooperative, Inc.* v. *FERC* , 822 F.2d 1123 (D.C. Cir. 1987). 6 *Mid-Tex Electric Cooperative, Inc.* v. *FERC* , 773 F.2d 327 (D.C. Cir. 1985). 7 *Mid-Tex* , at 1129-30. 8 *Mid-Tex* , at 1130. 4. The *Mid-Tex* court also concluded that the Commission had good cause to adopt an interim rule without prior notice and comment. 9 The Administrative Procedure Act permits rulemaking without prior notice and comment when an agency “for good cause * * * finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest.” 10 In its order adopting the interim rule regarding CWIP, the Commission emphasized three factors for foregoing prior notice and comment. First, the Commission stressed both the interim nature of the CWIP rule and the ongoing public process in formulating a permanent CWIP policy. Second, the Commission observed that the fundamental policy underlying the CWIP had been accepted by the court. Third, the Commission took notice that an interim rule was needed to avoid regulatory confusion. 9 *Mid-Tex* , at 1132. 10 5 U.S.C. 553(b)(3)(B) (2000). 5. Guided by the standards in *Mid-Tex* , the Commission has structured this interim rule in accordance with the court's decision in *National Fuel* while the Commission conducts a public notice and comment process for promulgating a final rule. The Commission has adhered to both the letter and the spirit of the court's decision in *National Fuel* by fashioning an interim rule under which the standards of conduct do not apply to the relationship between natural gas transmission providers and energy affiliates, which is the aspect of the standards of conduct that the court found infirm. 6. The issuance of this interim rule is also consistent with the three factors articulated in *Mid-Tex* for issuing an interim rule without prior notice and comment under the Administrative Procedures Act. First, the Commission stresses that the instant interim rule is not intended to serve as a permanent rule and that it is commencing a rulemaking proceeding through the issuance in the very near future of a NOPR. Second, the interim rule follows both the letter and spirit of the court's opinion in *National Fuel* because, for natural gas pipelines, it eliminates the provisions of Order No. 2004 that were subject to appeal and instead adopts provisions originally promulgated in Order No. 497, which was upheld in relevant part by the court in *Tenneco Gas* v. *FERC* . 11 Third, the Commission needs to issue an interim rule to avoid regulatory confusion. When the Commission adopted Order No. 2004, it rescinded the standards of conduct promulgated by Order No. 497. 12 Because *National Fuel* vacated Order No. 2004 as applied to natural gas transmission providers, there are no existing regulations governing the relationship between natural gas transmission providers and their marketing affiliates. This interim rule repromulgates rules from Order No. 2004 that were not challenged on appeal. With respect to provisions that were challenged, as noted, the Commission is temporarily re-adopting the standards of conduct provisions promulgated under Order No. 497. Otherwise, there would be no rules in place governing the relationship between natural gas pipelines and their affiliates—a situation which the Commission believes would not be in the public interest as such rules have for almost two decades played an important role in the agency's program to ensure non-discriminatory access by pipeline customers to competitive wellhead markets. 11 *Inquiry Into Alleged Anticompetitive Practices related to Marketing Affiliates of Interstate Pipelines,* Order No. 497, 53 FR 223139 (1988), FERC Stats. & Regs., Regulations Preambles 1986-1990 ¶ 30,820 (1988); Order No. 497-A, *order on reh'g* , 54 FR 52781 (1989), FERC Stats & Regs., Regulations Preambles 1986-1990 ¶ 30,868 (1989); Order No. 497-B, *order extending sunset date* , 55 FR 53,291 (1990), FERC Stats. & Regs., Regulations Preambles 1986-1990 ¶ 30,908 (1990); Order No. 497-C, *order extending sunset date* , 47 FR 9 (1992), FERC Stats. & Regs., Regulations Preambles 1991-1996 ¶ 30934 (1991), *reh'g denied* , 47 FR 5815 (1992), 58 FERC ¶ 61,139 (1992); *aff'd in part and remanded in part sub nom. Tenneco Gas v. FERC* , 969 F.2d 1187 (D.C. cir. 1992). 12 Order No. 2004, *supra* note 1, (in the description of the revisions to Title 18 of the Code of Federal Regulations). 7. Accordingly, in this interim rule, for natural gas transmission providers, the Commission modifies the regulations originally promulgated by Order No. 2004 consistent with the court's decision and issues appealed. The interim regulations will make clear that the standards of conduct apply to the relationship between natural gas transmission providers and marketing affiliates, and that the standards of conduct will not govern the relationship between natural gas transmission providers and their other energy affiliates. Because Order No. 2004 defined marketing differently than Order No. 497, the Commission is revising the definition of marketing consistent with Order No. 497. 13 13 Since the standards of conduct will no longer govern the relationship between natural gas transmission providers and their energy affiliates, this addresses the issue concerning the scope of the energy affiliate exception for local distribution companies appealed by National Fuel Gas Distribution Corporation and National Fuel Gas Supply raised in *National Fuel* . 8. Although the court did not consider petitioners' appeals with respect to specific sections of Part 358 as it vacated Order No. 2004 based on the lack of record support for the new definition of energy affiliate, the interim regulations will treat each of the sections challenged on appeal as if the court had held those sections infirm as well. Specifically, for natural gas transmission providers, the interim rule will:
(1)omit restrictions on shared risk management activities and employees 14 and
(2)revise the requirement to post all discretionary acts. 15 Also raised on appeal were two issues discussed in the preamble of Order No. 2004, but not codified in regulatory text. Here, too, although the court did not consider these issues, the Commission will incorporate into this preamble modifications consistent with petitioners' appeals of Order No. 2004 as if the court had ruled in their favor. Specifically, the Commission will
(1)allow natural gas transmission providers to treat lawyers as permissibly shared employees; and
(2)not require newly certificated natural gas pipeline transmission providers to observe the standards of conduct until they commence transmission services. 14 18 CFR 358.4(a)(6) (2006). 15 18 CFR 385.5(c)(4) (2006). 9. In the very near future, the Commission will issue a NOPR, which will seek comments on adopting permanent changes to Part 358 consistent with *National Fuel* . As a result, the Commission expects that the provisions in the interim rule will remain in effect until we have completed the rulemaking process for a final rule for Standards of Conduct for Transmission Providers. The Commission further expects the process for adopting a final rule to proceed without delay. II. Background A. Order No. 2004 10. Prior to Order No. 2004, the Commission had two separate sets of regulations governing standards of conduct for transmission providers. The regulations applicable to natural gas pipelines were issued in Order No. 497 in 1988, 16 pursuant to the agency's statutory authority under sections 4 and 5 of the Natural Gas Act. 17 In 1996, the Commission issued Order No. 889, 18 which created standards of conduct regulations applicable to electric public utilities under sections 205 and 206 of the Federal Power Act. 19 Both rules had the same goal: To prevent transmission providers from exercising their control over transmission to engage in undue discrimination or preference in favor of their marketing affiliates over non-affiliates. Both rules employed the same general approach: Requiring employees engaged in transmission services to function independently from employees of its marketing affiliates and imposing prohibitions restricting transmission providers from sharing certain information with their marketing affiliates. 16 *See supra* note 10. 17 15 U.S.C. 717c and 717d (2000). *See also* former 18 CFR part 161 (2003). 18 *Open Access Same-Time Information System (Formerly Real-Time Information Network) and Standards of Conduct* , Order No. 889, 61 FR 21737 (May 10, 1996), FERC Stats. & Regs., Regulations Preambles 1991-1996 ¶ 31,035 (Apr. 24, 1996); Order No. 889-A, *order on reh'g* , 62 FR 12484 (Mar. 14, 1997), FERC Stats. & Regs., Regulations Preambles 1996-2000 ¶ 31,049 (Mar. 4, 1997); Order No. 889-B, *reh'g denied* , 62 FR 64715 (Dec. 9, 1997), FERC Stats. & Regs., Regulations Preambles 1996-2000 ¶ 31,253 (Nov. 25, 1997). 19 16 U.S.C. 824d and 824e (2000). *See also* former 18 CFR 37.4 (2003). 11. In Order No. 2004, the Commission revised the standards of conduct so that one set of standards of conduct applied uniformly to both natural gas pipelines and electric public utilities. 20 The Commission also expanded the coverage of the standards of conduct to govern the relationships between transmission providers and energy affiliates. 21 Previously, the standards of conduct governed the relationship between transmission providers and their marketing affiliates. 22 20 Order No. 2004 at P 8. 21 The Commission defined energy affiliates as any affiliate that is engaged or involved in transmission transactions; manages or controls pipeline capacity; buys, sells, trades or administers natural gas in domestic energy or transmission markets; and engages in financial transactions relating to the sale or transmission of natural gas in such markets. 18 CFR 358.3(d) (2006). 22 Under Order No. 497, marketing included affiliates and business divisions engaged in making sales for resale of natural gas in interstate commerce (former 18 CFR 161.2(c)); and under Order No. 889, marketing covered affiliates and business divisions engaged in making sales for resale of electric energy in interstate commerce (former 18 CFR 37.3(e)). B. Matters Appealed 12. Five issues were appealed from Order No. 2004:
(1)Extension of the standards of conduct to cover the relationship between natural gas transmission providers and their energy affiliates under section 358.3(d);
(2)the scope of the restrictions on sharing risk management employees between the natural gas transmission providers and their marketing/energy affiliates under section 358.4(a)(6);
(3)the scope of the restrictions on sharing lawyers between natural gas transmission providers and their marketing/energy affiliates;
(4)the scope of the requirement that natural gas transmission providers post all discretionary acts under section 358.5(c)(4); and
(5)the timing as to when newly certificated pipelines become subject to the standards of conduct. C. The Court's Decision 13. In *National Fuel* , the court vacated Order No. 2004 as applicable to natural gas pipelines because of the expansion of the standards of conduct to include the new definition of energy affiliates. The court explained that the Commission relied on both theoretical grounds and on record evidence to justify this expansion. The court concluded that the Commission's record evidence did not withstand scrutiny and, thus, concluded the expansion was arbitrary and capricious in violation of the Administrative Procedure Act. 23 The court vacated Order No. 2004 as applicable to natural gas pipelines. In light of this disposition, the court did not address the other four issues raised on appeal regarding Order No. 2004. 23 *National Fuel* at 4. III. Discussion A. Partially Repromulgating Part 358 14. Much of Order No. 2004 codified case-by-case exceptions that had evolved during the implementation of Order Nos. 497 and 889, which were beneficial to the natural gas transmission providers and not appealed. Some of the provisions under Order No. 2004 that were not challenged on appeal included: codifying exceptions to the independent functioning requirement; 24 revising information sharing prohibitions to reflect practical considerations 25 and emergency circumstances; 26 codifying a training requirement; 27 revising and imposing new posting requirements to improve transparency; 28 and requiring the transmission providers to designate a chief compliance officer. 29 24 18 CFR 358.4 (2006). 25 18 CFR 358.5(b)(6) and
(8)(2006). 26 18 CFR 358.4(a)(2) (2006). 27 18 CFR 358.4(e)(5) (2006). 28 18 CFR 358.5(a) and
(b)(2006). 29 18 CFR 358.4(e)(6) (2006). 15. This interim rule maintains one set of standards of conduct regulations for both the natural gas and electric utility industries. The Commission, however, is only making changes applicable to natural gas transmission providers consistent with *National Fuel.* Therefore, the interim rule makes inapplicable to natural gas transmission providers those portions of the standards of conduct that the court found unsupportable or that were challenged on appeal. However, it also repromulgates those sections that were not appealed and not found infirm. 16. In response to several informal inquiries, the Commission also clarifies that waivers or exemptions that the Commission issued under Order No. 2004 are not negatively impacted by the *National Fuel* decision. B. Natural Gas Transmission Providers and Their Energy Affiliates 17. Because the court's decision focused on the Commission's lack of evidence to support expanding the standards of conduct to govern the relationship between natural gas transmission providers and their energy affiliates, the interim rule adds a new provision stating that the standards of conduct do not govern the relationship between natural gas transmission providers and their energy affiliates. The effect of this change, along with the modification to the definition of marketing as discussed below, is that the standards of conduct for natural gas transmission providers will only govern the relationship between a transmission provider and its marketing affiliates, consistent with the prior standards of conduct before the adoption of Order No. 2004. New section 358.1(e) reads as follows: The standards of conduct in this part do not govern the relationship between a natural gas Transmission Provider as defined in § 358.3(a)(2) and its Energy Affiliates. C. New Definition of Marketing Affiliate 18. Order No. 2004 revised the definition of marketing affiliate previously codified by Order No. 497. As a result, the interim rule will promulgate regulations that mirror the exceptions to the definition of marketing that were found in Order No. 497. 30 Specifically, a new provision at section 358.3(l) provides as follows: 30 Former 18 CFR 161.2(c) (2003). Marketing or brokering under section 358.3(e) means a sale of natural gas to any person or entity by a seller that is not an interstate pipeline, except when:
(1)The seller is selling gas solely from its own production;
(2)The seller is selling gas solely from its own gathering or processing facilities; or
(3)The seller is an intrastate natural gas pipeline or a local distribution company making an on-system sale. D. Sharing of Risk Management Employees 19. Prior to Order No. 2004, the standards of conduct were silent on whether a transmission provider could share risk management employees with its marketing affiliates. In reviewing the standards of conduct procedures submitted by Vector Pipeline, however, the Commission held that a natural gas pipeline could not share risk management employees if the functions included assessing the creditworthiness of a transmission customer. 31 Subsequently, in Order No. 2004, the Commission reiterated that holding and permitted the sharing of risk management employees provided that they were not “engaged in transmission functions or sales or commodity functions with their Marketing or Energy Affiliate.” 32 INGAA appealed this issue. 31 *Vector Pipeline, L.P.* , 97 FERC ¶ 61,085 (2001). 32 Order No. 2004 at P 112. *See also* 18 CFR 358.4(a)(6) (2006). 20. As mentioned above, the court did not address the risk management exception in the independent functioning requirement. Still, because it was raised as an issue on appeal, the Commission believes that to be faithful to the court's decision, section 358.4(a)(6) must be amended. Therefore, the Commission is adding, on an interim basis, a second sentence to that section as follows: This provision does not apply to natural gas transmission providers. E. Discretionary Tariff Provision 21. In Order No. 2004, the Commission required the transmission provider to maintain a log detailing the circumstances and manner in which it exercised discretion under any terms of its tariff and post it on its OASIS or internet Web site. 33 The regulatory language in Order No. 2004 was substantively identical to the requirement under Order No. 889, but it was different than the requirement under Order No. 497. Former section 161.3(k) promulgated under Order No. 497 required a pipeline to maintain a written log of waivers that the pipeline grants with respect to tariff provisions that provide for such discretionary waivers and provide the log to any person requesting it within 24 hours of the request. On appeal, one of the petitioners claimed that section 358.5(c)(4) was much broader than former section 161.3(k), arguing that there was a significant difference between granting waivers of tariff provisions that provide for such discretionary waivers (former section 161.3(k)) and exercising discretion under any terms of its tariff (section 358.5(c)(4)). 33 18 CFR 358.5(c)(4) (2006). 22. In response to the *National Fuel* decision, on an interim basis, the Commission is revising section 358.5(c)(4). First, we will make clear that 358.5(c)(4) only applies to electric public utility transmission providers and, second, we will adopt the language regarding discretionary waivers from Order No. 497 for natural gas transmission providers. Accordingly, we adopt the following language at section 358.5(c)(4):
(i)Electric Transmission Providers must maintain a written log, available for Commission audit, detailing the circumstances and manner in which they exercised their discretion under any terms of the tariff. The information contained in this log is to be posted on the OASIS or Internet Web site within 24 hours of when a Transmission Provider exercises its discretion under any terms of the tariff.
(ii)Natural gas Transmission Providers must maintain a written log of waivers that the natural gas Transmission Provider grants with respect to tariff provisions that provide for such discretionary waivers and provide the log to any person requesting it within 24 hours of the request. 23. The Commission recognizes that many natural gas transmission providers have put in place procedures to post information regarding discretionary waivers on their Internet Web sites. Of course, this is an acceptable means of complying with the requirement in lieu of providing the log to any person requesting it within 24 hours of the request. F. Sharing of Lawyers 24. With respect to the sharing of lawyers, under the Order No. 497 standards of conduct, lawyers were treated as permissibly shared employees. 34 Order No. 2004 was silent as to the classification of lawyers. In Order No. 2004-A, the Commission clarified that a lawyer who participates in transmission policy decisions on behalf of a Transmission Provider would be considered a transmission function employee (and hence, not permissibly shared). 35 Additionally, the Commission explained that lawyers may provide legal or regulatory advice in their traditional roles without becoming transmission function employees, 36 but, an individual's title of “lawyer” did not automatically exempt him/her from the independent functioning requirement. The Commission stated that if lawyers participate in transmission policy decisions on behalf of transmission providers, the Commission considers that participation to be a transmission function and the lawyers to be transmission function employees. 37 Following requests for clarification, the Commission stated that lawyers may provide legal or regulatory advice in their traditional roles without becoming transmission function employees, but to the extent that lawyers conduct transmission functions or are involved in planning, directing or organizing transmission functions, the lawyer's status as a “lawyer” does not exempt him/her from also being a transmission function employee. 38 34 Order No. 497 at 31,142. 35 Order No. 2004-A at P 157. 36 Section 358.3(j) defines transmission function employee as an employee, contractor, consultant or agent of a transmission provider who conducts transmission system operations or reliability functions, including, but not limited to, those who are engaged in day-to-day duties and responsibilities for planning, directing, organizing or carrying out transmission-related operations. 37 Order No. 2004-A at P 157. 38 Order No. 2004-B at P 74. 25. This issue was appealed. In light of the court's decision, the Commission clarifies that participating in business decisions by rendering legal advice does not make a lawyer a transmission function employee. Since this issue was discussed in the preamble to Order No. 2004, there is no regulatory text to adopt or revise. However, this clarification is intended to provide direction to the natural gas industry that the Commission will treat lawyers as permissibly shared employees for natural gas transmission providers. G. Timing of When a Natural Gas Transmission Provider Becomes Subject to the Standards of Conduct 26. Under Order No 497, a natural gas transmission provider became subject to the standards of conduct when the transmission provider commenced transportation transactions with its marketing or brokering affiliate. 39 In the preamble of Order No. 2004, the Commission stated that newly formed transmission providers would become subject to the standards of conduct when the transmission providers begin soliciting business or negotiating contracts, as those are activities which the Commission considers transmission function activities. Since the timing of applicability of the standards of conduct was one of the items on appeal, the Commission will treat this issue as if the court had ruled against the Commission on this issue. As a result, the Commission will not require natural gas transmission providers to observe the standards of conduct until they commence transportation transactions with their marketing affiliates. Because this issue was discussed in the preamble to Order No. 2004, there is no regulatory text to adopt or revise. However, in the interim, the foregoing statement is intended to provide direction to the industry with respect to when the Commission will consider natural gas transmission providers subject to the standards of conduct. 39 Former 18 CFR 161.1 (2003). IV. Information Collection Statement 27. The Office of Management and Budget
(OMB)regulations require approval of certain information collection requirements imposed by agency rules. 40 Previously, the Commission submitted to OMB the information collection requirements arising from the standards of conduct adopted in Order No. 2004. OMB approved those requirements. 41 This interim rule does not impose any additional information collection burden on industry participants. 40 5 CFR 1320.11 (2006). 41 Letter from OMB to the Commission (Jan. 20, 2004) (OMB Control Number 1902-0157); “Notice of Action” letter from OMB to the Commission (Jan. 20, 2004) (OMB Control Number 1902-0173). 28. The Commission is submitting notification of the information collection requirements imposed in the Interim Rule to OMB for its review and approval under section 3507(d) of the Paperwork Reduction Act of 1995. 42 Comments are solicited on the Commission's need for this information, whether the information will have practical utility, the accuracy of provided burden estimates, ways to enhance the quality, utility, and clarity of the information to be collected, and any suggested methods of minimizing respondent's burden, including the use of automated information techniques. 42 44 U.S.C. 3507(d) (2000). 29. OMB regulations require OMB to approve certain information collection requirements imposed by agency rule. The Commission is submitting notification of this proposed rule to OMB. *Title:* FERC-592. *Action:* Proposed Collection. *OMB Control No:* 1902-0157. *Respondents:* Business or other for profit. *Frequency of Responses:* On occasion. *Necessity of the Information:* The information is necessary to ensure that all regulated transmission providers treat all transmission customers in a non-discriminatory basis. *Internal Review:* The Commission has reviewed the requirements pertaining to natural gas pipelines and determined the interim rule is necessary to avoid a regulatory gap. 30. These requirements conform to the Commission's plan for efficient information collection, communication, and management within the natural gas and electric public utility industries. The Commission has assured itself, by means of internal review, that there is specific, objective support for the burden estimates associated with the information requirements. 31. Interested persons may obtain information on the reporting requirements by contacting: Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, [Attention: Michael Miller, Office of the Chief Information Officer], phone:
(202)502-8415, fax:
(202)208-2425, e-mail: *Michael.miller@ferc.gov* . Comments on the requirements of the proposed rule also may be sent to the Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503 [Attention: Desk Officer for the Federal Energy Regulatory Commission]. V. Environmental Analysis 32. The Commission is required to prepare an Environmental Assessment or an Environmental Impact Statement for any action that may have a significant adverse effect on the human environment. 43 The Commission has categorically excluded certain actions from these requirements as not having a significant effect on the human environment. 44 The action proposed here falls within the categorical exclusions provided in the Commission's regulations because this rule is clarifying and corrective and does not substantially change the effect of the regulations being amended. 45 Therefore, an environmental assessment is unnecessary and has not been prepared in this rulemaking. 43 Order No. 486, Regulations Implementing the National Environmental Policy Act, 52 FR 47897 (Dec. 17, 1987), FERC Stats. & Regs. Preambles 1986-1990 ¶ 30,783 (1987). 44 18 CFR 380.4 (2006). 45 18 CFR 380.4(a)(2)(ii) and 380.4(a)(5) (2006). VI. Regulatory Flexibility Act 33. The Regulatory Flexibility Act of 1980 46 generally requires a description and analysis of final rules that will have significant economic impact on a substantial number of small entities. Because most transmission providers do not fall within the definition of “small entity,” 47 the Commission certifies that this rule will not have a significant economic impact on a substantial number of small entities. VII. Document Availability 34. In addition to publishing the full text of this document in the **Federal Register** , the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the Internet through FERC's Home Page ( *http://www.ferc.gov* ) and in FERC's Public Reference Room during normal business hours (8:30 a.m. to 5 p.m. Eastern time) at 888 First Street, NE., Room 2A, Washington DC 20426. 35. From FERC's Home Page on the Internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field. 36. User assistance is available for eLibrary and the FERC's website during normal business hours from our Help line at
(202)502-8222 or the Public Reference Room at
(202)502-8371 Press 0, TTY
(202)502-8659. E-Mail the Public Reference Room at *public.referenceroom@ferc.gov* . VIII. Effective Date and Congressional Notification 46 5 U.S.C. 601-612 (2000). 47 *See* 5 U.S.C. 601(3) (2000). 37. These regulations are effective on date of issuance. The Commission has determined, with the concurrence of the Administrator of the Office of Information and Regulatory Affairs of OMB, that this rule is not a “major rule” as defined in section 351 of the Small Business Regulatory Enforcement Fairness Act of 1996. The Commission will submit the interim rule to both houses of Congress and the General Accounting Office. 48 48 5 U.S.C. 801(a)(1)(A) (2000). List of Subjects in 18 CFR Part 358 Electric power plants, Electric utilities, Natural gas, Reporting and recordkeeping requirements. By the Commission. Magalie R. Salas, Secretary. In consideration of the foregoing, the Commission revises part 358, Chapter I, Title 18, *Code of Federal Regulations* , to read as follows. PART 358—STANDARDS OF CONDUCT Sec. 358.1 Applicability. 358.2 General principles. 358.3 Definitions. 358.4 Independent functioning. 358.5 Non-discrimination requirements. Authority: 15 U.S.C. 717-717w, 3301-3432; 16 U.S.C. 791-825r, 2601-2645; 31 U.S.C. 9701; 42 U.S.C. 7101-7352. § 358.1 Applicability.
(a)This part applies to any interstate natural gas pipeline that transports gas for others pursuant to subpart A of part 157 or subparts B or G of part 284 of this chapter.
(b)This part applies to any public utility that owns, operates, or controls facilities used for the transmission of electric energy in interstate commerce.
(c)This part does not apply to a public utility Transmission Provider that is a Commission-approved Independent System Operator
(ISO)or Regional Transmission Organization (RTO). If a public utility transmission owner participates in a Commission-approved ISO or RTO and does not operate or control its transmission facilities and has no access to transmission, customer or market information covered by § 358.5(b), it may request an exemption from this part.
(d)A Transmission Provider may file a request for an exemption from all or some of the requirements of this part for good cause.
(e)The Standards of Conduct in this part do not govern the relationship between a natural gas Transmission Provider as defined in § 358.3(a)(2) and its Energy Affiliates. § 358.2 General principles.
(a)A Transmission Provider's employees engaged in transmission system operations must function independent from employees of its Marketing and Energy Affiliates.
(b)A Transmission Provider must treat all transmission customers, affiliated and non-affiliated, on a non-discriminatory basis, and must not operate its transmission system to preferentially benefit its Marketing or Energy Affiliates. § 358.3 Definitions.
(a)*Transmission Provider* means:
(1)Any public utility that owns, operates or controls facilities used for the transmission of electric energy in interstate commerce; or
(2)Any interstate natural gas pipeline that transports gas for others pursuant to subpart A of part 157 or subparts B or G of part 284 of this chapter.
(3)A Transmission Provider does not include a natural gas storage provider authorized to charge market-based rates that is not interconnected with the jurisdictional facilities of any affiliated interstate natural gas pipeline, has no exclusive franchise area, no captive ratepayers and no market power.
(b)*Affiliate* means:
(1)Another person that controls, is controlled by or is under common control with, such person. An Affiliate includes a division that operates as a functional unit,
(2)For any exempt wholesale generator, as defined under Section 32(a) of the Public Utility Holding Company Act of 1935, as amended, the same as provided in section 214 of the Federal Power Act.
(c)*Control* (including the terms “controlling,” “controlled by,” and “under common control with”) as used in this part and § 250.16 of this chapter, includes, but is not limited to, the possession, directly or indirectly and whether acting alone or in conjunction with others, of the authority to direct or cause the direction of the management or policies of a company. A voting interest of 10 percent or more creates a rebuttable presumption of control.
(d)*Energy Affiliate* means an affiliate of a Transmission Provider that:
(1)Engages in or is involved in transmission transactions in U.S. energy or transmission markets; or
(2)Manages or controls transmission capacity of a Transmission Provider in U.S. energy or transmission markets; or
(3)Buys, sells, trades or administers natural gas or electric energy in U.S. energy or transmission markets; or
(4)Engages in financial transactions relating to the sale or transmission of natural gas or electric energy in U.S. energy or transmission markets.
(5)A local distribution company division of an electric public utility Transmission Provider shall be considered the functional equivalent of an Energy Affiliate, unless it qualifies for the exemption in § 358.3(d)(6)(v).
(6)An Energy Affiliate does not include:
(i)A foreign affiliate that does not participate in U.S. energy markets;
(ii)An affiliated Transmission Provider or an interconnected foreign affiliated natural gas pipeline that is engaged in natural gas transmission activities that are regulated by the state, provincial or national regulatory boards of the foreign country in which such facilities are located.
(iii)A holding, parent or service company that does not engage in energy or natural gas commodity markets or is not involved in transmission transactions in U.S. energy markets;
(iv)An affiliate that purchases natural gas or energy solely for its own consumption. “Solely for its own consumption” does not include the purchase of natural gas or energy for the subsequent generation of electricity.
(v)A State-regulated local distribution company that acquires interstate transmission capacity to purchase and resell gas only for on-system sales, and otherwise does not engage in the activities described in §§ 358.3(d)(1), (2),
(3)or (4), except to the limited extent necessary to support on-system sales and to engage in *de minimis* sales necessary to remain in balance under applicable pipeline tariff requirements.
(vi)A processor, gatherer, Hinshaw pipeline or an intrastate pipeline that makes incidental purchases or sales of *de minimis* volumes of natural gas to remain in balance under applicable pipeline tariff requirements and otherwise does not engage in the activities described in §§ 358.3(d)(1), (2),
(3)or (4).
(e)*Marketing, sales or brokering* means a sale for resale of natural gas or electric energy in interstate commerce. Sales and marketing employee or unit includes:
(1)An interstate natural gas pipeline's sales operating unit, to the extent provided in § 284.286 of this chapter, and
(2)A public utility Transmission Provider's energy sales unit, unless such unit engages solely in bundled retail sales.
(3)Marketing or sales does not include incidental purchases or sales of natural gas to operate interstate natural gas pipeline transmission facilities.
(f)*Transmission* means natural gas transportation, storage, exchange, backhaul, or displacement service provided pursuant to subpart A of part 157 or subparts B or G of part 284 of this chapter; and electric transmission, network or point-to-point service, reliability service, ancillary services or other methods of transportation or the interconnection with jurisdictional transmission facilities.
(g)*Transmission Customer* means any eligible customer, shipper or designated agent that can or does execute a transmission service agreement or can or does receive transmission service, including all persons who have pending requests for transmission service or for information regarding transmission.
(h)*Open Access Same-time Information System or OASIS* refers to the Internet location where a public utility posts the information, by electronic means, required by part 37 of this chapter.
(i)*Internet Web site* refers to the Internet location where an interstate natural gas pipeline posts the information, by electronic means, required by §§ 284.12 and 284.13 of this chapter.
(j)*Transmission Function employee* means an employee, contractor, consultant or agent of a Transmission Provider who conducts transmission system operations or reliability functions, including, but not limited to, those who are engaged in day-to-day duties and responsibilities for planning, directing, organizing or carrying out transmission-related operations.
(k)*Marketing Affiliate* means an Affiliate as that term is defined in § 358.3(b) or a unit that engages in marketing, sales or brokering activities as those terms are defined at § 358.3(e).
(l)*Marketing or brokering* under § 358.3(e) means a sale of natural gas to any person or entity by a seller that is not an interstate pipeline, except when:
(1)The seller is selling gas solely from its own production;
(2)The seller is selling gas solely from its own gathering or processing facilities; or
(3)The seller is an intrastate natural gas pipeline or a local distribution company making an on-system sale. § 358.4 Independent functioning.
(a)*Separation of functions.*
(1)Except in emergency circumstances affecting system reliability, the transmission function employees of the Transmission Provider must function independently of the Transmission Provider's Marketing or Energy Affiliates' employees.
(2)Notwithstanding any other provisions in this section, in emergency circumstances affecting system reliability, a Transmission Provider may take whatever steps are necessary to keep the system in operation. Transmission Providers must report to the Commission and post on the OASIS or Internet Web site, as applicable, each emergency that resulted in any deviation from the standards of conduct, within 24 hours of such deviation.
(3)The Transmission Provider is prohibited from permitting the employees of its Marketing or Energy Affiliates from:
(i)Conducting transmission system operations or reliability functions; and
(ii)Having access to the system control center or similar facilities used for transmission operations or reliability functions that differs in any way from the access available to other transmission customers.
(4)Transmission Providers are permitted to share support employees and field and maintenance employees with their Marketing and Energy Affiliates.
(5)Transmission Providers are permitted to share with their Marketing or Energy Affiliates senior officers and directors who are not “Transmission Function Employees” as that term is defined in § 358.3(j). A Transmission Provider may share transmission information covered by § 385.5(a) and
(b)with its shared senior officers and directors provided that they do not participate in directing, organizing or executing transmission system operations or marketing functions; or act as a conduit to share such information with a Marketing or Energy Affiliate.
(6)Transmission Providers are permitted to share risk management employees that are not engaged in Transmission Functions or sales or commodity Functions with their Marketing and Energy Affiliates. This provision does not apply to natural gas transmission providers.
(b)*Identifying affiliates on the public Internet.*
(1)A Transmission Provider must post the names and addresses of Marketing and Energy Affiliates on its OASIS or Internet Web site.
(2)A Transmission Provider must post on its OASIS or Internet Web site, as applicable, a complete list of the facilities shared by the Transmission Provider and its Marketing and Energy Affiliates, including the types of facilities shared and their addresses.
(3)A Transmission Provider must post comprehensive organizational charts showing:
(i)The organizational structure of the parent corporation with the relative position in the corporate structure of the Transmission Provider, Marketing and Energy Affiliates;
(ii)For the Transmission Provider, the business units, job titles and descriptions, and chain of command for all positions, including officers and directors, with the exception of clerical, maintenance, and field positions. The job titles and descriptions must include the employee's title, the employee's duties, whether the employee is involved in transmission or sales, and the name of the supervisory employees who manage non-clerical employees involved in transmission or sales.
(iii)For all employees who are engaged in transmission functions for the Transmission Provider and marketing or sales functions or who are engaged in transmission functions for the Transmission Provider and are employed by any of the Energy Affiliates, the Transmission Provider must post the name of the business unit within the marketing or sales unit or the Energy Affiliate, the organizational structure in which the employee is located, the employee's name, job title and job description in the marketing or sales unit or Energy Affiliate, and the employee's position within the chain of command of the Marketing or Energy Affiliate.
(iv)The Transmission Provider must update the information on its OASIS or Internet Web site, as applicable, required by §§ 358.4(b)(1),
(2)and
(3)within seven business days of any change, and post the date on which the information was updated.
(v)The Transmission Provider must post information concerning potential merger partners as affiliates within seven days after the potential merger is announced.
(vi)All OASIS or Internet Web site postings required by part 358 must comply, as applicable, with the requirements of § 37.6 or §§ 284.12(a) and (c)(3)(v) of this chapter.
(c)*Transfers* . Employees of the Transmission Provider, Marketing or Energy Affiliates are not precluded from transferring among such functions as long as such transfer is not used as a means to circumvent the Standards of Conduct. Notices of any employee transfers between the Transmission Provider, on the one hand, and the Marketing or Energy Affiliates on the other, must be posted on the OASIS or Internet Web site, as applicable. The information to be posted must include: the name of the transferring employee, the respective titles held while performing each function ( *i.e.* , on behalf of the Transmission Provider, Marketing or Energy Affiliate), and the effective date of the transfer. The information posted under this section must remain on the OASIS or Internet Web site, as applicable, for 90 days.
(d)*Books and records.* A Transmission Provider must maintain its books of account and records (as prescribed under parts 101, 125, 201 and 225 of this chapter) separately from those of its Energy Affiliates and these must be available for Commission inspections.
(e)*Written procedures.*
(1)By February 9, 2004, each Transmission Provider is required to file with the Commission and post on the OASIS or Internet Web site a plan and schedule for implementing the standards of conduct.
(2)Each Transmission Provider must be in full compliance with the standards of conduct by September 22, 2004.
(3)The Transmission Provider must post on the OASIS or Internet Web site, current written procedures implementing the standards of conduct in such detail as will enable customers and the Commission to determine that the Transmission Provider is in compliance with the requirements of this section by September 22, 2004 or within 30 days of becoming subject to the requirements of part 358.
(4)Transmission Providers will distribute the written procedures to all Transmission Provider employees and employees of the Marketing and Energy Affiliates.
(5)Transmission Providers shall train officers and directors as well as employees with access to transmission information or information concerning gas or electric purchases, sales or marketing functions. The Transmission Provider shall require each employee to sign a document or certify electronically signifying that s/he has participated in the training.
(6)Transmission Providers are required to designate a Chief Compliance Officer who will be responsible for standards of conduct compliance. § 358.5 Non-discrimination requirements.
(a)*Information access.*
(1)The Transmission Provider must ensure that any employee of its Marketing or Energy Affiliate may only have access to that information available to the Transmission Provider's transmission customers ( *i.e.* , the information posted on the OASIS or Internet Web site, as applicable), and must not have access to any information about the Transmission Provider's transmission system that is not available to all users of an OASIS or Internet Web site, as applicable.
(2)The Transmission Provider must ensure that any employee of its Marketing or Energy Affiliate is prohibited from obtaining information about the Transmission Provider's transmission system (including, but not limited to, information about available transmission capability, price, curtailments, storage, ancillary services, balancing, maintenance activity, capacity expansion plans or similar information) through access to information not posted on the OASIS or Internet Web site or that is not otherwise also available to the general public without restriction.
(b)*Prohibited disclosure.*
(1)An employee of the Transmission Provider may not disclose to its Marketing or Energy Affiliates any information concerning the transmission system of the Transmission Provider or the transmission system of another (including, but not limited to, information received from non-affiliates or information about available transmission capability, price, curtailments, storage, ancillary services, balancing, maintenance activity, capacity expansion plans, or similar information) through non-public communications conducted off the OASIS or Internet Web site, through access to information not posted on the OASIS or Internet Web site that is not contemporaneously available to the public, or through information on the OASIS or Internet Web site that is not at the same time publicly available.
(2)A Transmission Provider may not share any information, acquired from non-affiliated transmission customers or potential non-affiliated transmission customers, or developed in the course of responding to requests for transmission or ancillary service on the OASIS or Internet Web site, with employees of its Marketing or Energy Affiliates, except to the limited extent information is required to be posted on the OASIS or Internet website in response to a request for transmission service or ancillary services.
(3)If an employee of the Transmission Provider discloses information in a manner contrary to the requirements of § 358.5(b)(1) and (2), the Transmission Provider must immediately post such information on the OASIS or Internet Web site.
(4)A non-affiliated transmission customer may voluntarily consent, in writing, to allow the Transmission Provider to share the non-affiliated customer's information with a Marketing or Energy Affiliate. If a non-affiliated customer authorizes the Transmission Provider to share its information with a Marketing or Energy Affiliate, the Transmission Provider must post notice on the OASIS or Internet Web site of that consent along with a statement that it did not provide any preferences, either operational or rate-related, in exchange for that voluntary consent.
(5)A Transmission Provider is not required to contemporaneously disclose to all transmission customers or potential transmission customers information covered by § 358.5(b)(1) if it relates solely to a Marketing or Energy Affiliate's specific request for transmission service.
(6)A Transmission Provider may share generation information necessary to perform generation dispatch with its Marketing and Energy Affiliate that does not include specific information about individual third party transmission transactions or potential transmission arrangements.
(7)Neither a Transmission Provider nor an employee of a Transmission Provider is permitted to use anyone as a conduit for sharing information covered by the prohibitions of §§ 358.5(b)(1) and
(2)with a Marketing or Energy Affiliate. A Transmission Provider may share information covered by §§ 358.5(b)(1) and
(2)with employees permitted to be shared under §§ 358.4(a)(4),
(5)and
(6)provided that such employees do not act as a conduit to share such information with any Marketing or Energy Affiliates.
(8)A Transmission Provider is permitted to share information necessary to maintain the operations of the transmission system with its Energy Affiliates.
(c)*Implementing tariffs* .
(1)A Transmission Provider must strictly enforce all tariff provisions relating to the sale or purchase of open access transmission service, if these tariff provisions do not permit the use of discretion.
(2)A Transmission Provider must apply all tariff provisions relating to the sale or purchase of open access transmission service in a fair and impartial manner that treats all transmission customers in a non-discriminatory manner, if these tariff provisions permit the use of discretion.
(3)A Transmission Provider must process all similar requests for transmission in the same manner and within the same period of time.
(i)Electric Transmission Providers must maintain a written log, available for Commission audit, detailing the circumstances and manner in which they exercised their discretion under any terms of the tariff. The information contained in this log is to be posted on the OASIS or Internet website within 24 hours of when a Transmission Provider exercises its discretion under any terms of the tariff.
(ii)Natural gas Transmission Providers must maintain a written log of waivers that the natural gas Transmission Provider grants with respect to tariff provisions that provide for such discretionary waivers and provide the log to any person requesting it within 24 hours of the request.
(5)The Transmission Provider may not, through its tariffs or otherwise, give preference to its Marketing or Energy Affiliate, over any other wholesale customer in matters relating to the sale or purchase of transmission service (including, but not limited to, issues of price, curtailments, scheduling, priority, ancillary services, or balancing).
(d)*Discounts.* Any offer of a discount for any transmission service made by the Transmission Provider must be posted on the OASIS or Internet Web site contemporaneous with the time that the offer is contractually binding. The posting must include: the name of the customer involved in the discount and whether it is an affiliate or whether an affiliate is involved in the transaction, the rate offered; the maximum rate; the time period for which the discount would apply; the quantity of power or gas upon which the discount is based; the delivery points under the transaction; and any conditions or requirements applicable to the discount. The posting must remain on the OASIS or Internet Web site for 60 days from the date of posting. [FR Doc. E7-659 Filed 1-18-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF HOMELAND SECURITY Bureau of Customs And Border Protection 19 CFR Part 123 Required Advance Electronic Presentation of Cargo Information for Truck Carriers: ACE Truck Manifest AGENCY: Customs and Border Protection, Department of Homeland Security. ACTION: Notice. SUMMARY: Pursuant to section 343(a) of the Trade Act of 2002 and implementing regulations, truck carriers and other eligible parties are required to transmit advance electronic truck cargo information to the Bureau of Customs and Border Protection
(CBP)through a CBP-approved electronic data interchange. In a previous notice, CBP designated the Automated Commercial Environment
(ACE)Truck Manifest System as the approved interchange and announced that the requirement that advance electronic cargo information be transmitted through ACE would be phased in by groups of ports of entry. The previous notice identified the first group of ports where use of the ACE Truck Manifest System is mandated. This notice announces the second group of land border ports that will require truck carriers to file electronic manifests through the ACE Truck Manifest System. DATES: Trucks entering the United States through land border ports of entry in the states of California, Texas, and New Mexico will be required to transmit the advance information through the ACE Truck Manifest system effective April 19, 2007. FOR FURTHER INFORMATION CONTACT: Mr. James Swanson, via e-mail at *james.d.swanson@dhs.gov* . SUPPLEMENTARY INFORMATION: Background Section 343(a) of the Trade Act of 2002, as amended (the Act; 19 U.S.C. 2071 note), required that CBP promulgate regulations providing for the mandatory transmission of electronic cargo information by way of a CBP-approved electronic data interchange
(EDI)system before the cargo is brought into or departs the United States by any mode of commercial transportation (sea, air, rail or truck). The cargo information required is that which is reasonably necessary to enable high-risk shipments to be identified for purposes of ensuring cargo safety and security and preventing smuggling pursuant to the laws enforced and administered by CBP. On December 5, 2003, CBP published in the **Federal Register** (68 FR 68140) a final rule to effectuate the provisions of the Act. In particular, a new § 123.92 (19 CFR 123.92) was added to the regulations to implement the inbound truck cargo provisions. Section 123.92 describes the general requirement that, in the case of any inbound truck required to report its arrival under § 123.1(b), if the truck will have commercial cargo aboard, CBP must electronically receive certain information regarding that cargo through a CBP-approved EDI system no later than 1 hour prior to the carrier's reaching the first port of arrival in the United States. For truck carriers arriving with shipments qualified for clearance under the FAST (Free and Secure Trade) program, § 123.92 provides that CBP must electronically receive such cargo information through the CBP-approved EDI system no later than 30 minutes prior to the carrier's reaching the first port of arrival in the United States. ACE Truck Manifest Test On September 13, 2004, CBP published a notice in the **Federal Register** (69 FR 55167) announcing a test allowing participating Truck Carrier Accounts to transmit electronic manifest data for inbound cargo through ACE, with any such transmissions automatically complying with advance cargo information requirements as provided in section 343(a) of the Trade Act of 2002. Truck Carrier Accounts participating in the test were given the ability to electronically transmit the truck manifest data and obtain release of their cargo, crew, conveyances, and equipment via the ACE Portal or electronic data interchange messaging. A series of notices announced additional deployments of the test, with deployment sites being phased in as clusters. Clusters were announced in the following notices published in the **Federal Register** : 70 FR 30964 (May 31, 2005); 70 FR 43892 (July 29, 2005); 70 FR 60096 (October 14, 2005); 71 FR 3875 (January 24, 2006); 71 FR 23941 (April 25, 2006); 71 FR 42103 (July 25, 2006); and 71 FR 77404 (December 26, 2006). CBP continues to test ACE at various ports. CBP will continue, as necessary, to announce in subsequent notices in the **Federal Register** the deployment of the ACE truck manifest system test at additional ports. Designation of ACE Truck Manifest System as the Approved Data Interchange System In a notice published October 27, 2006, (71 FR 62922), CBP designated the Automated Commercial Environment
(ACE)Truck Manifest System as the approved EDI for the transmission of required data and announced that the requirement that advance electronic cargo information be transmitted through ACE would be phased in by groups of ports of entry. ACE will be phased in as the required transmission system at some ports even while it is still being tested at other ports. However, the use of ACE to transmit advance electronic truck cargo information will not be required in any port in which CBP has not first conducted the test. The October 27, 2006, document identified all land border ports in the states of Washington and Arizona and the ports of Pembina, Neche, Walhalla, Maida, Hannah, Sarles, and Hansboro in North Dakota as the first group of ports where use of the ACE Truck Manifest System is mandated. ACE Mandated at Ports of Entry in California, Texas and New Mexico Applicable regulations (19 CFR 123.92(e)) require CBP, 90 days prior to mandating advance electronic information at a port of entry, to publish notice in the **Federal Register** informing affected carriers that the EDI system is in place and fully operational. Accordingly, CBP is announcing in this document that, effective 90 days from the date of publication of this notice, truck carriers entering the United States at any land border port of entry in the states of California, Texas, and New Mexico will be required to present advance electronic cargo information regarding truck cargo through the ACE Truck Manifest System. Although other systems that have been deemed acceptable by CBP for transmitting advance truck manifest data will continue to operate and may still be used in the normal course of business for purposes other than transmitting advance truck manifest data, use of systems other than ACE will no longer satisfy advance electronic cargo information requirements at a port of entry in California, Texas and New Mexico as of April 19, 2007. Compliance Sequence CBP will be publishing subsequent notices in the **Federal Register** as it phases in the requirement that truck carriers utilize the ACE system to present advance electronic truck cargo information at other ports. ACE will be phased in as the mandatory EDI system at the ports identified below in the sequential order in which they are listed. The sequential order provided below is somewhat different from that announced in the October 27, 2006, notice. Although further changes to this order are not currently anticipated, CBP will state in future notices if changes do occur. In any event, as mandatory ACE is phased in at these remaining ports, CBP will always provide 90 days' notice through publication in the **Federal Register** prior to requiring the use of ACE for the transmission of advance electronic truck cargo information at a particular group of ports. The remaining ports at which the mandatory use of ACE will be phased in, listed in sequential order, are as follows: 1. All ports of entry in the state of New York and Michigan. 2. All ports of entry in the states of Vermont, New Hampshire, and Maine. 3. All ports of entry in the states of Idaho and Montana. 4. The remaining ports of entry in the state of North Dakota and the land border port of Minnesota. 5. All ports of entry in the state of Alaska. Dated: January 16, 2007. Deborah J. Spero, Acting Commissioner, Customs and Border Protection. [FR Doc. E7-762 Filed 1-18-07; 8:45 am] BILLING CODE 9111-14-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 800 [Docket No. 2003N-0056 (formerly 03N-0056)] Medical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and Acceptance Criteria; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correction. SUMMARY: The Food and Drug Administration
(FDA)is correcting a final regulation that appeared in the **Federal Register** of December 19, 2006 (71 FR 75865). The document issued a final regulation that improves the barrier quality of medical gloves marketed in the United States (U.S.). The rule will accomplish this by reducing the current acceptable quality levels
(AQLs)for leaks and visual defects observed during FDA testing of medical gloves. By reducing the AQLs for medical gloves, FDA will also harmonize its AQLs with consensus standards developed by the International Organization for Standardization
(ISO)and ASTM International (ASTM). The document was published with some errors in the use of references. This document corrects those errors. DATES: This correction is effective on January 19, 2007. FOR FURTHER INFORMATION CONTACT: Casper E. Uldriks, Office of Compliance, Center for Devices and Radiological Health (HFZ-300), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 240-276-0100. SUPPLEMENTARY INFORMATION: In FR Doc. E6-21591, appearing on page 75865 in the **Federal Register** of Tuesday, December 19, 2006, the following corrections are made to the SUPPLEMENTARY INFORMATION . 1. On page 75868, in the second column, section III of the document is corrected to read: “III. Analysis of Impacts A. Introduction FDA has examined the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is not a significant regulatory action under the Executive order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of the rule on small entities. Because this final rule will not result in economic impacts on domestic small entities, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any Federal mandate that may result in the expenditure of State, local and tribal governments, in the aggregate, or the private sector of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $122 million, using the most current
(2005)implicit price deflator for the Gross National Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount. The information in the following sections sets forth the bases for the previous conclusions. We show the expected annual costs and benefits of this final rule next in table 1. The average annualized costs of the final rule are estimated to be $6.6 million using either a 3-percent or 7-percent discount rate. Average annualized benefits are expected to be between $14.8 million and $15.1 million, depending on the discount rate. Average annualized net benefits are between $8.2 million and $8.5 million. **Table 1.—Average Annualized Costs and Benefits (in millions)** 1 Annual Discount Rate Costs Benefits Net Benefits 3 Percent $6.6 $14.8 $8.2 7 Percent $6.6 $15.1 $8.5 1 Annualized over a 10-year evaluation period. B. Objective of the Final Rule The objective of the final rule is to reduce the risk of transmission of blood-borne pathogens (particularly human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C
(HCV)infections). The rule accomplishes this objective by ensuring that medical gloves (surgeons' and patient examination gloves) maintain a high level of quality with respect to the level of noted defects. FDA is also harmonizing its level for acceptable defects with consensus quality standards developed by ISO and ASTM. C. Current Risks of Blood-Borne Illness Unnecessary exposures to blood-borne pathogens are of great importance to the health care community because contact with contaminated human blood or tissue products has led to increased cases of HIV, HBV, and HCV infections. Available data cannot precisely quantify the number of new HIV cases that this final rule will prevent. This analysis, however, attempts to derive a conservative estimate. For the year 2000, the Centers for Disease Control
(CDC)reported a cumulative total of approximately 900,000 persons in the United States who had contracted HIV, of which 775,000 cases had progressed to Acquired Immunodeficiency Syndrome (AIDS). Of those patients whose conditions had progressed to AIDS, almost 450,000 (58 percent) had died as of December 2000. For the year 2000, the CDC identified 21,704 new cases of HIV infection (Ref. 1). Approximately 5 percent of the reported HIV/AIDS cases were among health care personnel (Ref. 2). However, in an indepth analysis of occupational risk, the CDC reported that between 1992 and 2002 there had been 56 identified incidents of occupational transmission of the HIV pathogen and all but 7 of these cases (12.5 percent) were due to percutaneous cuts or needlesticks. In addition, there were 138 other cases of HIV infection or AIDS among health care workers with occupational exposures to blood who had not reported other risk factors for HIV infection (Ref. 3). Assuming the same 12.5-percent rate for these workers implies that 17 additional cases of HIV transmission to health care workers during this period might have been caused by cutaneous contact in an occupational setting. Consequently, a total of 24 incidents of occupational transmission of HIV to health care personnel may have occurred over the 10-year period (or 2.4 per year) due to problems with the barrier protection properties of gloves used in health care settings. The CDC also reports approximately 80,000 new cases of HBV for the latest available reporting period
(2001)(Ref. 4). There are approximately 1.25 million people in the United States chronically infected with HBV. While only 6 percent of those who contract hepatitis B after the age of 5 will develop chronic conditions, 15 to 25 percent of those that do will die prematurely. Health care personnel are at some risk from this pathogen, but the availability of a vaccine has reduced the risk of negative outcomes due to exposure. (Ref. 5). FDA has no direct data for estimating the rate of new HBV infections in health care personnel. While the CDC has reported the risk to health care workers as “low,” there is no definition of that term (Ref. 6). FDA estimates that as many as 4,000, or 5 percent, of all new incidents of HBV occur in health care personnel. Because occupational transmissions for HBV may be approximately 5 times more likely than that for HIV, FDA imputes approximately 140 annual cases of occupational transmission of HBV to health care personnel (HIV rate of 7.3/1,085 x 5 x 4,000). CDC analyses communicate that a large portion of HBV infections in health care personnel are the result of direct or indirect blood or bodily fluid exposures that inoculated HBV into cutaneous scratches, abrasions, burns, other lesions, or on mucosal surfaces (Ref. 7). Because 2.4 of the 7.3 annual HIV cutaneous contact transmissions (33 percent) were believed to be attributable to glove defects, FDA similarly expects about one-third of the 140 annual occupational transmissions of HBV infections (approximately 40 cases) may potentially be associated with the current quality level of medical gloves. If only 6 percent of these cases develop chronic conditions, then an average of 2.4 annual cases of chronic HBV are associated with defective medical gloves. HCV currently infects 3.9 million persons in the United States. Over 2.7 million patients have reported chronic conditions. (Ref. 8). More than 40,000 new cases were reported in 1999. The risk of exposure to health care workers, however, appears to be extremely low. In fact, according to the CDC, other than from needle stick punctures, there has been no documented transmission of HCV to health care personnel from intact or non-intact skin exposures to blood or other fluids or tissues (Ref. 9). Thus, there is little evidence that glove defects are associated with HCV exposures. As a result, FDA estimates the overall annual transmission of blood-borne pathogens due to defects in glove barrier protection in health care settings to include 2.4 cases of HIV infection and 2.4 cases of HBV infection. Increasing the AQL of gloves by lowering the rate of acceptable defects should reduce the transmission rates of these pathogens. D. Baseline Conditions The previous AQL (being replaced by this rule) for medical gloves allowed a defect rate of 4.0 percent for patient examination gloves and 2.5 percent for surgeons' gloves. The AQL represents the proportion of sampled gloves from a given lot that may include defects such as leaks or foreign material and still be accepted for entry into the marketplace. Currently, if more than 4 percent of the sampled patient examination gloves exhibit defects in accordance with the sampling criteria, the entire lot of gloves is considered adulterated. Surgeons' gloves are sampled to a higher quality level (lower AQL requires a higher proportion of non-defective gloves in order to pass inspection), because these products have a higher likelihood of contact with bodily fluids. Of course, medical glove lots that fail to meet the AQL may be marketed as household or other products. If a sample of gloves fails to meet the AQL, the marketer may request resampling of the lot. The required sampling plan for a lot originally found to be out of compliance is more intensive than the original sampling plan for a randomly selected lot. Lots initially found to be out of compliance are either resampled and subsequently offered as medical devices after meeting the current AQL, offered as nonmedical gloves, or sold in foreign markets. Approximately 39.5 billion medical gloves were imported into the United States during 2004 (Ref. 10). According to FDA records, there are over 400 manufacturers of medical gloves. Malaysian manufacturers supply almost 40 percent of the medical gloves in the United States while Thailand manufacturers supply approximately 30 percent (Ref. 11). Surgeons' gloves accounted for only about 15 percent of all imported medical gloves during 2004, and the impact of the final rule on this sector is negligibly different from overall patient examination gloves. Therefore, this analysis focuses exclusively on patient examination gloves. FDA expects the demand for medical gloves to increase by the same rate as employment in the medical services industry. The Bureau of Labor Statistics has projected annual employment growth of 2.6 percent for this industry (North American Industry Classification System 6200) (Ref. 12), which implies an annual volume of over 50 billion medical gloves in 10 years. (A 2.6 annual growth rate results in an expected increase of 29.3 percent in 10 years.) Medical glove lot sizes may vary from as few as 25 gloves to as many as 500,000. According to discussions with manufacturers (Eastern Research Group, Inc. (ERG), 2001), a typical production or import lot from a foreign manufacturer contains an average of 325,000 gloves (either patient examination or surgeons'). This implies that the U.S. medical glove market currently imports over 120,600 lots of gloves per year. FDA currently samples only about 1.5 percent of all glove lots, or 1,800 lots per year. Within 10 years, FDA expects the number of lots offered for import to increase to 156,000. If the compliance sampling rate remains constant, FDA would sample about 2,300 lots during that year. FDA's Winchester Engineering and Analytical Center
(WEAC)analyzed results from samples collected from 2000 and 2001. These samples represent approximately one-third of FDA's total sampling effort for the period. (Ref. 13). A total of 98,067 gloves were tested from 942 separate lots. Of these gloves, 2,354 were defective, which implies that 2.4 percent of marketed gloves are likely to be defective. (Ref. 14) If so, then approximately 940 million defective medical gloves are currently marketed (39.2 billion gloves x 0.024). At the current AQL of 4.0, 28 lots (2.97 percent) failed. Consequently, approximately 53 annually sampled lots are defective (1,800 sampled lots x 0.0297). By the 10th year, in the absence of the final regulation, 1.21 billion defective gloves would be marketed and 68 of the sampled lots would fail to meet the AQL. FDA allows glove lots that fail to meet the AQL to be resampled. Sponsors usually attempt to resample the glove lot rather than divert the entire lot to alternative markets. According to discussions with industry sources and testing laboratories, the cost of glove lot resampling and retesting for leakage and tensile strength is approximately $1,400. The current annual industry cost of resampling glove lot failures with the current AQL is approximately $74,000 (53 lots times $1,400 per lot). This resampling and retesting cost would equal $95,000 within 10 years. E. Costs of the Final Rule FDA expects that the final rule will result in changed shipping practices by medical glove manufacturers. Currently, manufacturers use the target AQLs as a guide for releasing production lots of gloves for export to the United States because the release criteria are lower in the United States than in other markets. Manufacturers attempt to avoid having three failures within a 24-month period, because this may result in refusal of future imports under Level 3 detention described in FDA's current policy, “Surveillance and Detention Without Physical Examination of Surgeon's and/or Patient Examination Gloves.” Thus, to maintain an uninterrupted supply of gloves to customers, and to guard brand loyalty while avoiding Level 3 detention, manufacturers would be expected to raise their level of quality control to at least maintain the current average lot rejection rate of 2.97 percent. FDA also expects the rule to increase the costs of sampling by requiring larger and more detailed sampling plans to assure the lower AQL is met for each inspected glove lot. FDA does not envision increased regulatory oversight costs because the rate of inspections is not expected to change. Costs have been analyzed and discounted using the methodology suggested by the Office of Management and Budget's (OMB's) Circular A-4 (September 2003). 1. Costs of Quality Control Manufacturers currently conduct quality control tests on glove lots prior to release. These tests include water-tight leak and tensile strength assays. According to interviews with glove manufacturers, the current cost of conducting these tests at the manufacturing site is approximately $310 per lot, while the more stringent quality control testing required by this rule may cost an additional $45 per lot. The additional cost is for increased inventory and larger sample sizes to ensure more precise measurements at the lower AQL. Because approximately 120,600 lots are currently imported per year, the expected costs are $5.4 million (120,600 lots x $45 per lot). The expected increase in the demand for medical gloves by the 10th evaluation year will result in a compliance cost of meeting this increased quality level of $7.0 million. Over the 10-year period, the average annualized cost of this increased level of testing, at a 3-percent annual discount rate, is $6.2 million and, at a 7-percent annual discount rate, is $6.2 million. 2. Increased Sampling Costs A lower AQL will result in increased sampling costs for imported glove lots. The increased sampling costs will result from the need to test greater quantities of gloves in order to ensure sufficient statistical power. Based on reported costs from U.S. testing laboratories, ERG, an independent economic contractor, estimated that increased testing would add approximately $200 to the current costs of $1,400 per sample. (The difference between this increased cost and the $45 increased quality control cost is attributable to lower costs in foreign countries that produce medical gloves.) FDA currently samples about 1.5 percent of the 120,600 lots imported annually, or 1,800 samples. Thus, the increased sampling costs due to this final rule are $0.4 million (120,600 lots x 0.015 x $200). Within 10 years, this increased cost will equal $0.5 million (due to expected increases in the number of inspected glove lots). The average annualized sampling cost increase at a 3-percent annual discount rate is $0.4 million, and at a 7-percent annual discount rate is $0.4 million. 3. Withheld Lots The lower AQL in this final rule is also likely to result in an increase in the number of lots of medical gloves that are not released for shipment to the U.S. medical market. For example, manufacturers may attempt to maintain a target compliance level in order to avoid FDA's Level 3 detention under “Surveillance and Detentions Without Physical Examination of Surgeon's and or Patient Examination Gloves.” FDA's WEAC laboratory sampled 942 lots and discovered that 28 failed using the current AQL while 79 lots failed using the lower AQL in this final rule. (Ref. 15) To maintain the original 0.0297 (28/942) lot failure rate, the 53 lots with the highest defect rate would have to be held back by the affected manufacturers (.056) 1 . 1 The current lot failure rate (28/942 = 0.0297) is reached by removing 53 defective lots from the sample. If only the 51 additional failing lots are removed, the overall failure rate is 0.0314 (28/891). The expected future failure rate is 0.0292 (26/889). FDA expects the withheld lots to include those with the highest defect rates. Therefore, FDA anticipates that under the lower AQL in the final rule, approximately 6,900 lots will be held back by manufactures. In order to meet the expected demand in 10 years, FDA expects that 9,000 lots will be held back. FDA believes that glove lots that fail to meet the lower AQL in this final rule for medical quality standards will most likely be sold as nonmedical gloves. FDA believes that, although manufacturers and distributors may experience some loss of revenue from this shift (because of the price premium commanded by medical gloves), the loss will be inconsequential. 4. Costs of FDA Inspections FDA does not envision increased inspection costs due to the final rule. The rate of sampled glove lots is not expected to differ and FDA resources are not expected to increase over the evaluation period. 5. Total Costs In sum, FDA estimates that the final rule will have an average annualized cost of about $6.6 million using either a 3-percent or 7-percent annual discount rate. Table 2 of this document presents the costs for each year of the evaluation period. **Table 2.—Costs per Year of the Final Rule (in millions)** Year Costs for Quality Control Costs for Sampling Total Costs Current $5.4 $0.4 $5.8 1 $5.6 $0.4 $6.0 2 $5.7 $0.4 $6.1 3 $5.9 $0.4 $6.3 4 $6.0 $0.4 $6.4 5 $6.2 $0.4 $6.6 6 $6.3 $0.4 $6.7 7 $6.5 $0.4 $6.9 8 $6.7 $0.4 $7.1 9 $6.8 $0.5 $7.3 10 $7.0 $0.5 $7.5 Present Values 3%-$53.2 7%-$43.4 3%-$3.6 7%-$2.9 3%-$56.8 7%-$46.3 F. Benefits of the Rule The final rule will result in public health gains by reducing the frequency of blood-borne pathogen transmissions due to defects in the barrier protection provided by medical gloves. Based on an implied societal willingness to pay (WTP), FDA expects that an annualized monetary benefit of $14.8 million (using a 3-percent discount rate) or $15.1 million (using a 7-percent discount rate) will be realized due to fewer pathogen transmissions and unnecessary blood screens. Fewer glove defects will reduce the cost and anxiety associated with unnecessary blood screens (i.e., those that would yield negative results for health care personnel). Benefits have been analyzed and discounted using the methodology suggested by OMB's Circular A-4 (September 2003). 1. Reductions in the Number of Marketed Defective Gloves As noted in the previous paragraphs, FDA has determined that approximately 940 million defective gloves are marketed each year in the United States, or 2.4 percent of all medical gloves. In the absence of this rule, FDA expects that the number of defective medical gloves marketed in the United States would increase to 1.21 billion per year within 10 years. The final rule will substantially reduce this figure. WEAC's analysis of 98,067 medical gloves from 942 sampled lots collected in 2000 and 2001 resulted in approximately 3-percent lot failures with an AQL of 4.0 (28 lots would fail). This lot failure rate was associated with 2,356 defective gloves, or 2.4 percent of the total number of sampled gloves. (Ref. 16). Under the lower AQL of 2.5 in the rule, the WEAC analysis concluded that 51 additional lots would fail (a total of 79 failed lots), increasing the lot failure rate from 2.91 percent to 8.39 percent. As previously mentioned, FDA provides a Level 3 detention status in its guidance, “Surveillance and Detentions Without Physical Examination of Surgeon's and or Patient Examination Gloves.” Manufacturers on Level 3 detention are not allowed to import medical gloves because they have repeatedly failed analysis. To avoid the denial of entry, manufacturers may be expected to hold a sufficient number of defective lots from shipment in order to maintain the same target lot failure rate (approximately 3 percent) with a new AQL. If so, removing the 53 most defective lots in the testing sample would result in 26 lot failures from 880 total lots, thereby maintaining the original 2.92 percent lot failure rate. This scenario leaves 85,172 total gloves in the sample, of which 1,512 were defective, resulting in a glove defect rate of 1.78 percent. The final rule, therefore, could reduce the proportion of marketed defective medical gloves from 2.4 percent of all marketed gloves to 1.78 percent of all marketed gloves. The implications of this expected reduction in defective gloves are significant. The current AQL is associated with 940 million glove defects during the present year (based on 2004) and within 10 years would result in 1.21 billion marketed defective medical gloves. When the lower AQL is in place, the current number of defective gloves will approximate 700 million and within 10 years will result in 900 million defective marketed gloves. The number of defective gloves, therefore, should be reduced by more than 25 percent due to the new AQL. 2. Reductions in Blood-Borne Pathogens FDA has estimated that there are potentially 4.8 annual transmissions of blood-borne pathogens associated with medical glove defects (section III.C of this document). These transmissions include 2.4 cases of HIV and 2.4 cases of chronic HBV. Because there are currently no documented cases of cutaneous transmission of HCV that would be affected by improving glove quality levels, this analysis does not consider potential HCV transmission. a. *Reductions in HIV transmission* . While the direct relationship between defective medical gloves and the transmission of HIV is unknown, FDA believes it is reasonable to apply the proportional reduction in the number of defective gloves due to the final rule (about 25 percent) to the annual transmission rate of the HIV pathogen to health care personnel. In the absence of this rule, the current expectation of 2.4 annual cases of HIV transmission to health care personnel would likely increase to 3.1 annual cases within 10 years due to the expected growth of employment in the health services industry. However, with the new AQL in place, FDA forecasts the expected annual transmission of HIV to health care personnel to equal 1.8 cases in current conditions and 2.3 cases by the 10th evaluation year (based on the expected proportionate decrease in marketed defective gloves). Over the entire 10-year evaluation period, these assumptions suggest that the rule should prevent approximately seven cases of HIV transmission to health care personnel. b. *Reductions in HBV transmissions* . Hepatitis B transmissions to health care personnel are more common than cutaneous HIV transmissions. However, little specific data are available to identify affected patient populations and routes of transmission. FDA has estimated that as many as 2.4 cutaneous transmissions of chronic HBV may be due to defective medical gloves each year. In the absence of this rule, this number would be expected to increase to 3.1 annual transmissions within 10 years, based on the expected employment growth in the health services industry. Implementation of the final rule should decrease these transmissions by about 25 percent. FDA expects 1.8 HBV transmissions under current conditions, a reduction of 0.6 transmissions from baseline conditions. By the 10th evaluation year, FDA expects that there will be 2.3 chronic HBV transmissions with the lower AQL, or a total of 0.8 fewer cases. Overall, about 7 transmissions of chronic HBV will be avoided due to the final rule over a 10 year evaluation period. 3. Reductions in the Number of Blood Screening Tests As the number of defective gloves marketed in the United States decreases due to this rule, corresponding reductions would be expected in the number of unnecessary blood screens. FDA contacted several research hospitals to ascertain how frequently health care personnel identify glove failure as a reason for initiating blood screens. Respondents stated that about 5-percent of all glove failures are noticed by the user and about 1 percent of these identified failures are reported to the facility for additional screening (Ref. 17). Respondents noted that the glove failure could occur prior to patient contact. Therefore, the additional screening may apply to the affected health care personnel or the patient. The great majority of these screens result in negative findings. As shown in the previous paragraphs, when the final rule is in effect, FDA expects the number of defective gloves marketed to decrease from 940 million to 700 million, a reduction of 240 million defective gloves. By the 10th year, the number of defective gloves is expected to decrease from 1.21 billion to 900 million, a reduction of 310 million defective gloves. At the rates of potential identification (5 percent) and reports of contact with pathogens (1 percent) obtained from the research hospital sector, the final rule should result in 120,000 fewer unnecessary blood screens under current conditions (240 million fewer defects x 0.05 x 0.01). By the 10th year, 155,000 fewer annual blood screens are expected. Over the entire evaluation period, the rule could result in over 1.4 million fewer unnecessary blood screens. 4. Cost-Effectiveness of the Final Rule We analyzed the cost-effectiveness of the final rule using both the cost per transmission of blood-borne pathogen avoided and the cost per unnecessary blood screen avoided. The annual numbers of future avoided transmissions and tests were compared to the present values of the costs for the evaluation period and shown in table 3. Table 3 of this document shows the expected annual reductions in blood-borne pathogens and unnecessary blood screens due to the final rule. **Table 3.—Expected Annual Reductions in Blood-Borne Pathogen Transmissions and Unnecessary Blood Screens** Year Reduction in Blood-Borne Pathogen Transmission Reduction in Unnecessary Blood Screens Current 1.2 120,000 1 1.2 120,000 2 1.2 125,000 3 1.4 135,000 4 1.4 135,000 5 1.4 140,000 6 1.4 145,000 7 1.6 150,000 8 1.4 145,000 9 1.6 155,000 10 1.6 155,000 Although these reductions should continue beyond the evaluation period, we have analyzed only through the 10th year. Each year's expected number of reduced blood-borne pathogen transmissions and unnecessary blood screens are discounted (using both a 3-percent annual discount rate and a 7-percent annual discount rate) to arrive at an equivalent number of reductions if valued during the first evaluation year. The present values of the regulatory costs (shown in table 4 of this document) are divided by the present values of the expected reductions to arrive at the cost per avoided event. This is shown in table 4 of this document. **Table 4.—Regulatory Cost-Effectiveness per Incidence of Blood-Borne Pathogen Transmission Avoided and Unnecessary Blood Screen Avoided** Annual Discount Rate Present Value of Costs (in millions) Present Value of Blood-Borne Pathogens Avoided Cost per Blood-Borne Pathogen Avoided (in millions) Present Value of Blood Screens Avoided Cost per Blood Screen Avoided 3 percent $56.8 12.2 $4.7 1,191,000 $48 7 percent $46.3 9.8 $4.7 971,000 $48 The cost-effectiveness of the final rule is $4.7 million per transmission of blood-borne pathogen avoided, or $48 per unnecessary blood screen avoided for both discount rates. We note that both reductions should occur and the allocation of costs to each outcome would reduce the costs per avoided event for both. 5. Value of Avoiding Blood-Borne Pathogens a. *Quality adjusted life-years* . The economic literature includes many attempts to quantify societal values of health. A widely cited methodology assesses wage differentials necessary to attract labor to riskier occupations. This research indicates that society appears to be WTP approximately $5 million to avoid the probability of a statistical death (Ref. 18). That is, social values appear to show that people are WTP a significant amount to reduce even a small risk of death; or similarly, to demand significant payments to accept marginally higher risks. Because this estimate is predominantly based on blue-collar occupations that mainly attract males between the ages of 30 and 40, FDA adjusted the life-expectancy of a 35-year-old male to account for future bed and non-bed disability (Ref. 19), and amortized the $5 million (at both 3-percent and 7-percent discount rates) over the resulting quality-adjusted life span. The results were estimates of $213,000 per quality adjusted life-year
(QALY)using a 3-percent discount rate and $373,000 per QALY using a 7-percent discount rate, which implies that society is WTP between $213,000 and $373,000 for the statistical probability of a year of perfect health, depending on the discount rate. b. *Value of morbidity losses* . In theory, loss of health reduces the WTP for additional longevity. Many studies have attempted to estimate the relative loss of health for many different conditions of morbidity. One method utilizes the Kaplan-Bush Index of Well-Being. This index assigns relative weights to functional states, and then adjusts the resulting weighted value by the problem/symptom complex that contributed to loss of function (Ref. 20). Functional state is measured in three areas: Mobility, social activity, and physical activity. For example, with most treatment, chronic HBV is unlikely to have a major impact on any of these functions; a patient could drive a car, walk without a physical problem, and conduct work, school, housework and other activities. However, because a patient with HBV has an ongoing problem/symptom complex, the relative weight of this functional state is 0.7433 2 . (Ref. 21). 2 The implication is that an ideal health state is valued as 1.0000 and mortality at 0.0000. Each functional state between these extremes is a proportionate value of “perfect” health. This methodology then adjusts the weighted value of the functional state by the most severe problem/symptom complex contributing to that state. In the case of chronic HBV, the most common symptom is general tiredness, weakness, or weight loss. This complex has a derived relative weight of +0.0027, which when added to the weighted functional state value results in a relative weight of 0.7460. The loss of relative health due to HBV, therefore, is expected to equal 1.0000 minus 0.7460, or 0.2540 of perfect health. When this relative health loss is applied to the derived value of a QALY, it implies that society would be WTP between $54,000 (3 percent) and $93,000 (7 percent) per year to avoid a case of HBV (QALY value x 0.2540). This value includes the potential costs of treatment and additional prevention, as well as any perceived pain and suffering. FDA compared this methodology to a variety of published estimates of preference ratings of morbidity prepared by the Harvard Center for Risk Analysis (HCRA). The published ratings of 14 studies of chronic HBV ranged from 0.75 to 1.00 (no impact) (Ref. 22). While the estimate used in this analysis (0.746) is in the low end of collected published studies, FDA notes that most of the expressed preferences that were derived from time trade-off and standard gamble methodologies, as compared to author judgment, were closer to the FDA estimate. A health care worker who may contract HBV may typically have a life expectancy of approximately 40 years (as of the year 2000, a 40-year-old female had a future life expectancy of 41.1 years (Ref. 23)). The present value
(PV)of $54,000 (3 percent) and $93,000 (7 percent) for 40 years implies that society is WTP $1.25 million (3 percent) or $1.24 million (7 percent) to avoid the statistical likelihood of a case of chronic HBV in health care personnel. Deriving society's implied WTP to avoid HIV is more complicated. The CDC has published data indicating that approximately 80 percent of all HIV infections progress to AIDS within 5 years. Of the cases of AIDS, over half (approximately 60 percent) result in mortality within an additional 5 years. Thus, for a 10 year period, FDA tracked 3 potential outcomes: Patients who contract HIV but do not progress to AIDS (20 percent), patients who contract HIV and progress to AIDS in 5 years and survive (32 percent), and patients who contract HIV, progress to AIDS within 5 years and then die within an additional 5 years (48 percent). HIV infection is not expected to affect either mobility or social activity. However, such an infection is likely to somewhat inhibit physical activity. HIV patients are expected to be able to walk, but with some physical limitations. This functional state has a relative weight of 0.6769. The main problem/symptom complex of HIV is general tiredness (as for HBV), so the selected functional weight is adjusted by +0.0027 to result in relative well-being of 0.6796. As a result, the relative societal WTP to avoid the statistical probability of a case of HIV in health care personnel is approximately $68,000 (3 percent) or $120,000 (7 percent) per year (QALY value x (1.0000 minus 0.6796)). According to the collected preference scores in the HCRA's Catalog of Preference Scores, the average estimated published preference rating for HIV infection was 0.7 (range 0.3 to 1.00). (Ref. 24). If HIV progresses to AIDS, a patient's functional state is likely to be more restricted. An AIDS patient requires some assistance with transportation, is limited in physical activity, and is limited in work, school, or household activity. The relative weight for this functional state is 0.5402. The main problem/symptom of AIDS remains general tiredness and loss of weight (as with HIV and HBV), so the adjusted health state is 0.5429. This results in a derived societal WTP to avoid the statistical probability of a case of AIDS of about $97,000 (3 percent) or $170,000 (7 percent) per year (QALY value x (1.0000 minus 0.5429)). The HCRA's Catalog of Preference Scores reports average preference ratings of 0.375 for cases of AIDS with ranges from 0.0 to 0.5. (Ref. 25). As discussed earlier, the derived societal WTP to avoid a statistical mortality has been estimated to equal approximately $5 million. Using these estimates, the WTP to avoid the statistical probability of an HIV transmission in health care personnel is calculated as the sum of: • 20 percent of the PV (at 3-percent and 7-percent discount rates) of avoiding 40 years of HIV infection. • 32 percent of the sum of the PV of avoiding 5 years of a HIV infection plus the PV of avoiding 35 years of AIDS infection occurring 5 years in the future. • 48 percent of the sum of the PV of avoiding 5 years of HIV infection plus the PV of avoiding 5 years of AIDS infection occurring 5 years in the future plus the discounted WTP of avoiding a statistical mortality occurring 10 years in the future. The PV of avoiding 40 years of health loss valued at $68,000 per year (3 percent) is approximately $1.6 million and if valued at $120,000 per year (7 percent) is also approximately $1.6 million. Twenty percent of this figure equals $320,000. The PV of avoiding 5 years of health loss to due HIV infection is equal to $311,000 (3 percent) or $492,000 (7 percent). The PV of avoiding the health loss expected from 35 years of AIDS infection (valued at $97,000 (3 percent) and $170,000 (7 percent) per year) is equivalent to $2.1 million (3 percent) and $2.2 million (7 percent). The present values of these amounts occurring 5 years in the future are $1.8 million (3 percent) and $1.6 million (7 percent). When added to the PV of avoiding the health loss associated with 5 years of HIV infection ($311,000 (3 percent) and $492,000 (7 percent)), the total estimated PV of the societal WTP to avoid a statistical case of this outcome is about $2.1 million (for both 3-percent and 7-percent discount rates). Thirty-two percent of this figure equals $660,000. The PV of avoiding the health loss associated with 5 years of AIDS infection ($445,000 (3 percent) and $700,000 (7 percent)) occurring 5 years in the future is equivalent to $384,000 (3 percent) and $497,000 (7 percent). The PV of the societal value of avoiding a statistical mortality ($5 million) 10 years in the future is $3.72 million (at 3 percent) and $2.54 million (at 7 percent). The total societal WTP to avoid a case of HIV with mortality as an outcome, therefore, is $4.4 million using a 3-percent discount rate ($311,000 plus $384,000 plus $3.72 million) and $3.5 million using a 7-percent discount rate ($493,000 plus $497,000 plus $2.54 million). Forty-eight percent of these figures equals approximately $2.1 million (3 percent) and $1.7 million (7 percent). Summing the weighted amounts of the three expected outcomes for a case of HIV infection equals an estimated societal WTP of $3.08 million using a 3-percent discount rate ($320,000 plus $660,000 plus $2.1 million) and $2.68 million using a 7-percent discount rate ($320,000 plus $660,000 plus $1,700,000). In sum, the estimated societal values of avoiding morbidity and mortality due to transmission of blood-borne pathogens are estimated to be equivalent to $1.25 million per transmission of chronic HBV and $3.08 million per transmission of HIV using a 3-percent discount rate and $1.24 million per transmission of HBV and $2.68 million per transmission of HIV using a 7-percent discount rate. FDA notes that other cost-effectiveness research has determined cost-effectiveness estimates (excluding pain and suffering) of $2.1 million per avoided case of HIV. (Ref. 26). FDA believes the methodology used to estimate the value of avoided HBV and HIV infection is reasonable and supportable. However, comparative methodologies that demonstrate both higher and lower values on avoidance have been reported. FDA acknowledged these differences in the proposed rule and solicited comment on other appropriate measures for estimating the societal value of avoiding blood-borne pathogens. FDA received no responses. c. *Benefit of morbidity avoidance* . The rule is expected to reduce both HBV and HIV transmissions by reducing the prevalence of defective medical gloves used as barrier protection. During the first evaluation year, the rule is expected to result in 0.6 fewer chronic HBV transmissions to health care personnel. Applying the assumed societal WTPs of $1.25 million (3 percent) and $1.24 million (7 percent) to avoid the probability of an HBV infection, the expected benefit of avoiding these transmissions is $0.8 million (3 percent) and $0.7 million (7 percent). By the 10th evaluation year, 0.8 annual transmissions are expected to be avoided at a value of $1.0 million for either discount rate. The PV of avoiding approximately 7 chronic HBV transmissions over a 10-year period equals $7.6 million (at 3-percent discount rate) and $6.1 million (at 7-percent discount rate). This is equal to an average annualized value of $0.9 million for the entire 10-year evaluation period at either discount rate. Also, in the first evaluation year, FDA expects that the final rule will result in the probability of 0.6 fewer transmissions of HIV caused by defective gloves. Assuming that society is WTP $3.08 million (at 3-percent discount rate) and $2.68 million (at 7-percent discount rate) to avoid the probability of a single HIV transmission, the benefit of avoiding these transmissions equals $1.8 million (3 percent) and $1.6 million (7 percent). By the 10th evaluation year, FDA expects the final rule to result in 0.8 fewer HIV transmissions, which are valued at $2.5 million (3 percent) and $2.1 million (7 percent). The societal PV of avoiding seven transmissions of HIV over the 10-year evaluation period is $18.8 million (at 3-percent discount rate) and $13.1 million (at 7-percent discount rate). These values are equivalent to average annualized benefits of $2.2 million (at 3-percent discount rate) and $1.9 million (at 7-percent discount rate). In sum, FDA estimates that the reduction in blood-borne pathogen transmissions due to this final rule should produce health benefits valued at $3.1 million (at 3-percent discount rate) and $2.8 million (at 7-percent discount rate) per year. Most of this benefit (over 67 percent) is attributable to reducing the incidence of HIV. 6. Value of Avoiding Unnecessary Blood Screens The expected decline in the number of defective medical gloves should lead to fewer unnecessary blood screens and thereby provide two potential benefits. First, the direct cost of conducting screens to determine whether the pathogen was transmitted to health care personnel should decrease. Second, the psychological anxiety and stress that accompanies the possibility that a pathogen was transmitted to an individual should also decrease. a. *Cost of conducting blood screens* . FDA has collected data from the American Red Cross on the costs of conducting blood screening tests in order to ensure the safety of the blood supply. These estimates include the costs of collection (including personnel, needles, bags, and other supplies) at $47.66 per sample; sample testing at $25.16 per sample; and overhead at $3.26 per sample. The estimated direct testing cost per blood sample is the sum of these amounts, or $76 per test (Ref. 27). b. *Anxiety and stress associated with potential transmission of pathogens* . The psychological literature has noted that levels of anxiety and stress impact participation in public health screening programs and thereby affect physiological health (Ref. 28). Also, patients with high levels of uncertainty about whether they have contracted serious, threatening diseases experience heightened levels of stress and anxiety until they learn the results of any testing screens are negative (Ref. 29). According to one measurement scale of well-being, reduced mental lucidity, depression, crying, lack of concentration, or other signs of adverse psychological sequelae may detract as much as 8-percent from overall feelings of well-being and have outcomes similar to physiological morbidity (Ref. 30). Scaling of the relative stress caused by events shows that concerns about personal health, by themselves, are likely, on average, to contribute approximately one-sixth of the total weighting required to trigger a major stressful episode (Ref. 31). Thus, FDA approximates that increased stress and anxiety concerning possible exposure to pathogens may reduce overall sense of well-being and result in health loss of approximately 1.3 percent (0.013). As described earlier, FDA has calculated an assumed WTP of $213,000 (at 3 percent) and $373,000 (at 7 percent) for a statistical QALY. These figures imply that the probability of each day of quality adjusted life has a social value of about $585 (at 3-percent discount rate; $213,000 divided by 365) and $1,020 (at 7-percent discount rate; $373,000 divided by 365). If blood test results are usually obtained within 24 hours, the resultant loss of societal well-being for each test subject is valued at approximately $8 (at 3-percent discount rate; $585 x 0.013) and $13 (at 7-percent discount rate, $1,020 x 0.013). c. *Benefit of test avoidance* . By combining avoided direct costs of tests and the value of avoided anxiety and stress, FDA estimates that the societal benefit of avoiding an unnecessary blood test is $84 per sample (at 3-percent discount rate) and $89 per sample (at 7-percent discount rate). During the first evaluation year, FDA expects that there will be 120,000 fewer unnecessary blood screens because of the expected reduction in defective medical gloves due to the final rule. The implied societal WTP to avoid these unnecessary screens is $10.1 million (3 percent) and $10.7 million (7 percent). During the 10th evaluation year, approximately 155,000 fewer unnecessary blood screens are expected with a resultant benefit of $13.0 million (3 percent) and $14.0 million (7 percent). The PV of each year's reduced cost of testing and anxiety totals $100.0 million (at 3-percent discount rate) and $86.4 million (at 7-percent discount rate). The average annualized equivalent amounts are $11.7 million (3 percent) and $12.3 million (7 percent). Between 85 percent and 90 percent of the average annualized amounts represent reductions in the direct testing costs rather than the reduced anxiety associated with possible infection by a contagious agent. 7. Total Benefits FDA estimates that the final rule will reduce the availability of defective medical gloves by over 25 percent, resulting in over 2.8 billion fewer defective gloves over a 10-year period. During this time, FDA expects that the reduction in defective gloves will result in approximately 7 fewer cases of chronic HBV, 7 fewer cases of HIV, and 1.4 million fewer unnecessary blood screens. Based on an implied societal WTP, the average annualized benefits of the fewer pathogen transmissions and unnecessary blood screens should equal $14.8 million (at 3-percent annual discount rate) and $15.1 million (at 7-percent discount rate). G. Conclusion As noted in the introduction to the analysis of impacts section, FDA is certifying that the final rule will not have a significant impact on a substantial number of small entities. We provided the above information to explain the costs and benefits of the rule. There are currently over 400 manufacturers of medical gloves, a vast majority of which are foreign and not covered by the Regulatory Flexibility Act. There will be little to no impact on domestic entities. Moreover, FDA does not expect any increased manufacturer costs to be directly passed on to end users because the cost increases will affect only a minority of global manufacturers and, therefore, competition will likely force these manufacturers to absorb these costs. The estimated annualized costs equal $6.6 million using either a 3-percent annual discount rate or a 7-percent annual discount rate. Benefits of avoiding transmissions of blood-borne pathogens and unnecessary blood screens have been estimated to equal $14.8 million (using a 3-percent discount rate) or $15.1 million (using a 7-percent discount rate). The final rule is estimated to result in average annualized net benefits of $8.2 million (using a 3-percent discount rate) or $8.5 million (using a 7-percent discount rate).” 2. On page 75875, in the second column, section V of the document is corrected to read: “V. References The following references have been placed on display in the Division of Dockets Management and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. FDA has verified the Web site addresses, but is not responsible for subsequent changes to the Web site after this document publishes in the **Federal Register** . 1. Centers for Disease Control and Prevention (CDC), “HIV/AIDS Surveillance Report,” (vol. 12, no. 2) (pp 5-6), *http://www.cdc.gov/hiv/topics/surveillance/resources/reports/pdf/hasr1202.pdf* , 2000. 2. CDC, “Fact Sheet: Surveillance of Health Care Workers With HIV/AIDS,” *http://www.cdc.gov/hiv/pubs/facts/hcwsurv.htm* , 2001. 3. *Id.* 4. CDC, “Fact Sheet: Viral Hepatitis B,” *http://www.cdc.gov/ncidod/diseases/hepatitis/b/fact.htm* , 2003. 5. *Id.* 6. *Id.* 7. CDC, *Morbidity and Morality Weekly Report,* “Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis,” *http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5011a1.htm* , 2001. 8. CDC, “Fact Sheet: Viral Hepatitis C,” *http://www.cdc.gov/ncidod/diseases/hepatitis/c/fact.htm* , 2003. 9. *Id.* 10. U.S. International Trade Commission, Interactive Tariff and Trade Dataweb: Import Statistics, (Data file), available from *http://dataweb.usitc.gov/* , 2004. 11. Eastern Research Group, Inc., “Cost Analysis of the Labeling and Related Testing Requirements for Medical Glove Manufacturers (Table 2),” Lexington, MA: Eastern Research Group, Inc., March 2002. 12. Bureau of Labor Statistics, “Career Guide to Industries: Health Services,” *http://www.bls.gov/oco/cg/cgs035.htm* , 2002-2003. 13. Winchester Engineering & Analytical Center, Office of Regulatory Affairs Web Reports (data file), available from *http://webrpt.ora.fda.gov* (follow “Access Reports”), 2001. 14. *Id.* 15. *Id.* 16. *Id.* 17. Character, B. J., R. M. McLaughlin, C. S. Hedlund, et al., “Postoperative Integrity of Veterinary Surgical Gloves,” * Journal of the American Animal Hospital Association * , 39, pp. 311 to 320, May/June 2003. 18. Mudarri, D. H., “The Costs and Benefits of Smoking Restrictions: An Assessment of the Smoke-Free Environment Act of 1993,” (H.R. 3434) (p. 14), Washington, DC, U.S. Environmental Protection Agency, April 1994. 19. Mudarri, D. H., “The Costs and Benefits of Smoking Restrictions: An Assessment of the Smoke-Free Environment Act of 1993,” (H.R. 3434) (Appendix A-1), Washington, DC, U.S. Environmental Protection Agency; Kaplan, R. M., J. W. Bush, & C. C. Berry, Health Status: Types of Validity and the Index of Well-Being, *Health Services Research Journal* , pp. 478-507, winter 1976. 20. Kaplan, R. M., J. W. Bush, C. C. Berry, (1976, Winter), “Health Status: Types of Validity and the Index of Well-Being,” *Health Services Research Journal* , pp. 478-507; M. M. Chen, J. W. Bush, D. L. Patrick, (1975), “Social Indicators for Health Planning and Policy Analysis,” *Policy Sciences Journal* , 6, pp. 71-89; R. M. Kaplan, J. W. Bush, (1982), “Health Related Quality of Life Measurement for Evaluation Research and Policy Analysis,” *Health Psychology* , 1(1), pp. 61-80. 21. R. M. Kaplan, J. W. Bush, C. C. Berry, “Health Status: Types of Validity and the Index of Well-Being,” *Health Services Research Journal* , pp. 478-507, winter 1976. 22. Tufts—New England Medical Center. *The CEA Registry: Catalog of Preference Scores* , *http://www.tufts-nemc.org/cearegistry/data/phaseIIpreferenceweights.pdf* , April 5, 2006. 23. U.S. Census Bureau, *Statistical Abstract of the United States: 2002* , *http://www.census.gov/prod/2003pubs/02statab/vitstat.pdf* , 2002, December. 24. Tufts—New England Medical Center, *The CEA Registry: Catalog of Preference Scores* , *http://www.tufts-nemc.org/cearegistry/data/phaseIIpreferenceweights.pdf* , April 5, 2006. 25. *Id.* 26. M. G. Marin, J. Van Lieu, A. Yee, et al., “Cost-Effectiveness of a Post-Exposure HIV Chemoprophylaxis Program for Blood Exposures in Health Care Workers,” *Journal of Occupational and Environmental Medicine* , 41(9), pp. 754-760, September 1999. 27. “Time to Top Off Your Tank?: The Red Cross Says Blood Safety Costs Are Pumping Up Prices,” *The Washington Post* , p. T07, June 12, 2001. 28. Lerman, C., Schwartz, & Schwartz, Marc, “Adherence and Psychological Adjustment Among Women at High Risk for Breast Cancer,” *Breast Cancer Research and Treatment* , 28, pp. 145-155, 1993. 29. Shrout, P. E., “Scaling of Stressful Life Events,”
(in)Dohrenwend, B. Snell, B. P. Dohrenwend (Eds.), *Stressful Life Events & Their Contexts* (pp. 29-47), New Brunswick, NJ, Rutgers University Press, 1984. 30. Kaplan, R. M., J. W. Bush, C. C. Berry, “ Health Status: Types of Validity and the Index of Well-Being,” *Health Services Research Journal* , pp. 478-507, winter 1976. 31. E. Alderete, T. C. Juarbe, C. P. Kaplan, et al., “Depressive Symptoms Among Women With an Abnormal Mammogram,” *Psycho-Oncology* , 15, pp. 66-78, 2006.” Dated: January 11, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-682 Filed 1-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF DEFENSE Office of the Secretary 32 CFR Part 199 [DOD-2006-HA-0194; RIN 0720-AB07] TRICARE; Certain Survivors of Deceased Active Duty Members; and Adoption Intermediaries AGENCY: Office of the Secretary, DoD. ACTION: Interim Final Rule. SUMMARY: This interim final rule implements two provisions of the National Defense Authorization Act for Fiscal Year 2006 (NDAA FY06), Public Law 109-163. First, Section 715 of the NDAA FY06 extends the time frame certain dependents of Active Duty Service Members
(ADSM)who die while on active duty for more than 30 days shall receive TRICARE medical benefits at active duty dependent payment rates. Second, Section 592 of the NDAA FY06 modifies the requirement for those intermediaries who provide adoption placements. Additionally, this interim final rule makes an administrative clarification to the following two eligibility provisions: those placed in the legal custody of a member or former member; and those placed in the home of a member or former member in anticipation of adoption. This clarification makes a distinction between the two groups and specifies that for placement into legal custody by court order, the court order must be for a period of 12 consecutive months. Public comments are invited and will be considered for possible revisions to the final rule. DATES: This rule is effective March 20, 2007. *Comments:* Written comments received at the address indicated below by March 20, 2007 will be accepted. ADDRESSES: You may submit comments, identified by docket number and or RIN number and title, by any of the following methods: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. • Mail: Federal Docket Management System Office, 1160 Defense Pentagon, Washington, DC 20301-1160. *Instructions:* All submissions received must include the agency name and docket number or Regulatory Information Number
(RIN)for this **Federal Register** document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at *http://regulations.gov* as they are received without change, including any personal identifiers or contact information. FOR FURTHER INFORMATION CONTACT: Ms. Ann N. Fazzini,
(303)676-3803 for questions regarding Section 715 as it relates to the TRICARE Basic Program; and also questions regarding Section 592. Mr. Michael Kottyan,
(303)676-3520 for questions regarding Section 715 as it relates to the Extended Health Care Option (ECHO). Mr. John Leininger,
(303)676-3613, for questions regarding TRICARE Prime Remote. Questions regarding payment of specific claims should be addressed to the appropriate TRICARE contractor. SUPPLEMENTARY INFORMATION: The Department is publishing this rule as an interim final rule in order to meet statutorily required effective dates. The Department is not exercising any discretion in implementing these provisions. In accordance with Section 715(b), the effective date for Section 715 is October 7, 2001 and shall apply with respect to deaths occurring on or after that date. The Department has no discretion concerning the benefits available to surviving dependents, the effective date, nor the time periods benefits are available to surviving spouses and children respectively. The effective date for Section 592 is January 6, 2006. Prior to the NDAAFY06, a child placed in the home by a placement agency recognized by the Secretary of Defense in anticipation of the legal adoption of the person was eligible for TRICARE. Section 592 of the NDAA FY06 expands those intermediaries who perform adoption placement to include placement by any source authorized by State or local law to provide adoption placement. The Department is not exercising any discretion in defining who are intermediaries who can perform adoption placement. In accordance with Public Law 103-160, section 702(b), the effective date for placement by a court is July 1, 1994. In accordance with Public Law 103-337, section 701, the effective date for placement by a recognized adoption agency October 5, 1994. These last two changes are administrative corrections only. Public comments are invited and will be considered for possible revisions to the final rule. The effective date for Section 715 is October 7, 2001 and shall apply with respect to deaths occurring on or after that date. The effective date for Section 592 is January 6, 2006. In accordance with Public Law 103-160, section 702(b), the effective date for placement by a court is July 1, 1994. In accordance with Public Law 103-337, section 701, the effective date for placement by a recognized adoption agency October 5, 1994. I. Payment Rates for Dependents of Deceased Active Duty Service Members Introduction and Background Dependents of active-duty members who died while on active duty have been always eligible for TRICARE; however, their payment rates/cost-sharing provisions have changed over time. Initially, their cost-sharing provisions were at the retiree payment rate for all care received. This was amended by Section 707(c) of the National Defense Authorization Act for Fiscal Year 1995, Public Law 103-337, which provided for two changes. First, effective October 1, 1993, care was to be cost-shared at the active duty dependent payment rate for a one-year period. Second, for dependents of active duty members who died while on active duty between January 1, 1993, and October 1, 1993, only care for pre-existing conditions was cost-shared at the active duty dependent payment rate. An additional amendment to the time period for the payment rate for dependents of deceased active duty members was found in Section 704 of the Floyd D. Spence National Defense Authorization Act for Fiscal Year 2001. Section 704 added a two-year extension of the active-duty dependent cost-sharing provision which allowed survivors of deceased active duty members to remain eligible for TRICARE at the active duty dependent payment rate for a total of three years from the date of death. After three years, survivors remained eligible for TRICARE at the retiree payment rate. Section 715 of the NDAA-FY06 General Section 715 of the NDAA FY06 further modified the cost-sharing provision for certain dependents of deceased active duty members by adding the following subparagraph 1079(g)(2) to title 10, United States Code:
(2)In addition to any continuation of eligibility for benefits under paragraph (1), when a member dies while on active duty for a period of more than 30 days, the member's dependents who are receiving benefits under a plan covered by subsection
(a)shall continue to be eligible for benefits under TRICARE Prime during the three-year period beginning on the date of the member's death, except that, in the case of such a dependent of the deceased who is described by subparagraph
(D)or
(I)of section 1072(2) of this title, the period of continued eligibility shall be the longer of the following periods beginning on such date:
(A)Three years.
(B)The period ending on the date on which such dependent attains 21 years of age.
(C)In the case of such a dependent who, at 21 years of age, is enrolled in a full-time course of study in a secondary school or in a full-time course of study in an institution of higher education approved by the administering Secretary and was, at the time of the member's death, in fact dependent on the member for over one-half of such dependent's support, the period ending on the earlier of the following dates:
(i)The date on which such dependent ceases to pursue such a course of study, as determined by the administering Secretary.
(ii)The date on which such dependent attains 23 years of age.
(3)For the purposes of paragraph (2)(C), a dependent shall be treated as being enrolled in a full-time course of study in an institution of higher education during any reasonable period of transition between the dependent's completion of a full-time course of study in a secondary school and the commencement of an enrollment in a full-time course of study in an institution of higher education, as determined by the administering Secretary.
(4)The terms and conditions under which health benefits are provided under this chapter to a dependent of a deceased member under paragraph
(2)shall be the same as those that would apply to the dependent under this chapter if the member were living and serving on active duty for a period of more than 30 days.
(5)In this subsection, the term “TRICARE Prime” means the managed care option of the TRICARE program. Certain Dependents Section 715 of the NDAA FY06 changed the time frame that certain dependents shall continue to retain eligibility to enroll in TRICARE Prime at the active duty dependent payment rate and receive the same health benefits that would apply to them if the member were still living and serving on active duty. Section 715 applies to those dependents defined in 10 U.S.C. Chapter 55, subparagraph
(D)or
(I)of section 1072(2). In the supplementary section of this Interim Final Rule, those dependents in subparagraphs
(D)and
(I)are referred to as “certain dependents” and the specific legislative language for these two subparagraphs is outlined below. Subparagraph
(D)of 1072(2) addresses a child who—
(i)has not attained the age of 21;
(ii)has not attained the age of 23, is enrolled in a full-time course of study at an institution of higher learning approved by the administering Secretary and is, or was at the time of the member's or former member's death, in fact dependent on the member or former member for over one-half of the child's support; or
(iii)is incapable of self-support because of a mental or physical incapacity that occurs while a dependent of a member or former member under clause
(i)or
(ii)and is, or was at the time of the member's or former member's death, in fact dependent on the member or former member for over one-half of the child's support. Subparagraph
(I)addresses an unmarried person who—
(i)is placed in the legal custody of the member or former member as a result of an order of a court of competent jurisdiction in the United States (or possession of the United States) for a period of at least 12 consecutive months;
(ii)either—
(I)has not attained the age of 21;
(II)has not attained the age of 23 and is enrolled in a full time course of study at an institution of higher learning approved by the administering Secretary; or
(III)is incapable of self support because of a mental or physical incapacity that occurred while the person was considered a dependent of the member or former member under this subparagraph pursuant to subclause
(I)or (II);
(iii)is dependent on the member or former member for over one-half of the person's support;
(iv)resides with the member or former member unless separated by the necessity of military service or to receive institutional care as a result of disability or incapacitation or under such other circumstances as the administering Secretary may by regulation prescribe; and
(v)is not a dependent of a member or a former member under any other subparagraph. These certain dependents may avail themselves of the active duty dependent payment rates available under TRICARE Standard, Extra, or Prime and enjoy medical benefits at the active duty dependent payment rate in accordance with the time frames listed in Section 715. Of significance is the cost saving opportunity Section 715 presents for those certain dependents that choose to enroll in TRICARE Prime. Currently, there is no TRICARE Prime enrollment fee and no TRICARE Prime copayment for an active duty dependent Prime enrollee so those certain dependents who are enrolled in Prime also would have no Prime enrollment fee and no Prime copayment. Those certain dependents that choose TRICARE Standard or Extra would be responsible for the active duty payment rate (cost-share) applicable under those two programs. The active duty dependent payment rates for TRICARE Standard and Extra vary by type of service (inpatient, outpatient, etc.) and can be found in 32 CFR 199.4(f). TRICARE Prime Remote Because Section 715 references TRICARE Prime, the Department is interpreting this section to also include the TRICARE “Prime-like” benefit known as TRICARE Prime Remote (TPR). As a result, TPR will be available to surviving spouses and certain dependents whose sponsor died while on active duty for a period of more than 30 days. Surviving spouses will be eligible to enroll in TPR for a three-year period. Certain dependents will be eligible to enroll in TPR as long as they meet the criteria for being a dependent as described in 10 U.S.C. Chapter 55, subparagraph
(D)or
(I)of section 1072(2). For additional information on the TPR program, the reader should refer to the interim final rules that were published in the **Federal Register** on February 6, 2002, (67 FR 5477) and July 31, 2003 (68 FR 44883). Extended Care Health Option
(ECHO)Based on the Department's interpretation of Section 715 of the NDAA FY06, the ECHO is also available to surviving spouses and certain dependents of deceased active duty members because these surviving spouses and certain dependents are treated as if the sponsoring member were still living and serving on active duty. For additional information on the ECHO program, the reader should refer to the final rules that were published in the **Federal Register** on July 28, 2004, (69 FR 44942) and August 20, 2004, (69 FR 51559). Surviving Spouse We note that Section 715 of the NDAA FY 06 provision makes no change to the time frame that the surviving spouse shall receive care at the active duty dependent payment rate. Surviving spouses retain the three year period of TRICARE Prime, TPR, TRICARE Extra or TRICARE Standard at the active duty dependent payment rate. At the end of the three year period, surviving spouses continue eligibility for TRICARE benefits at the retiree payment rate. The provisions found in Section 715 are effective with respect to deaths occurring on or after October 7, 2001. II. Eligibility Determinations Section 715 of the NDAA FY06 authorizes the time frame that certain dependents shall retain active duty dependent payment rates for medical benefits available under TRICARE. The provision has no impact on eligibility rules. Consequently, this provision does not preclude loss of eligibility as a result of any condition which routinely results in loss of TRICARE eligibility such as reaching age limits, marriage, remarriage, etc. Although the TRICARE Management Activity is tasked with publishing legislatively mandated eligibility changes to Title 10 U.S.C., determination of dependent eligibility is the primary responsibility of the Uniformed Services. TRICARE relies primarily on the Defense Enrollment Eligibility Reporting System (DEERS) for eligibility verification. However, a determination by the Uniformed Services that a person is eligible does not automatically entitle such a person to TRICARE payments. Before any TRICARE benefits may be extended, additional requirements of 32 CFR Part 199 must be met. In accordance with 10 U.S.C. 1084, as implemented by § 199.3(h), disputes regarding eligibility as a dependent or dates of beginning eligibility for benefits under TRICARE can only be resolved by the appropriate Uniformed Service Secretary. III. Modification of Requirement for Certain Intermediaries Under Certain Authorities Relating to Adoptions Section 592 of the NDAA FY06 states that:
(a)Reimbursement for Adoption Expenses—Section 1052(g)(1) of title 10, United States Code, is amended by inserting ‘or other source authorized to place children for adoption under State or local law’ after ‘qualified adoption agency’.
(b)Treatment as Children for Medical and Dental Care Purposes—Section 1072(6)(D)(i) of such title is amended by inserting ‘, or by any other source authorized by State or local law to provide adoption placement,’ after ‘(recognized by the Secretary of Defense)’. Prior to the NDAA FY06, a child placed in the home by a placement agency recognized by the Secretary of Defense in anticipation of the legal adoption of the person was eligible for TRICARE. Section 592 of the NDAA FY06 expands those intermediaries who perform adoption placement to include placement by any source authorized by State or local law to provide adoption placement. This expanded language mirrors the language found in Title 10, Subpart A, Part II, Chapter 53, Section 1052, reimbursement for adoption expenses, and provides consistency between personnel benefit policies in chapter 53 of Title 10, United States Code, and eligibility for TRICARE under chapter 55 of Title 10, United States Code. Effective date of the NDAA FY06 (and this provision) is January 6, 2006. IV. Administrative Change—Court Order/Adoption Placement During the course of amending the regulation to incorporate the NDAA FY06 provisions, we identified the need for an administrative clarification to 32 CFR Part 199 Section 3. This interim final rule clarifies the eligibility provisions for an unmarried person who is placed in the legal custody of the member or former member as a result of an order of a court of competent jurisdiction in the United States (or possession of the United States) by stating that the court order must be for a period of at least 12 consecutive months. We currently address a child who is placed in legal custody of a member or former member, but the language unintentionally omitted the 12 consecutive month period required by 10 U.S.C. 1072(I)(i). Additionally, this rule clarifies that an unmarried person placed in legal custody of a member or former member is a category that is separate and distinct from those placed for adoption. We accomplish this by providing separate regulatory paragraphs for each group. For further information on these two groups, we refer the reader to the final rule that established these groups, 64 FR 46133, August 24, 1999. V. Regulatory Procedures We have examined the impact of the interim rule under Executive Order
(EO)13132 and it does not have policies that have federalism implications that would 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, therefore, consultation with State and local officials is not required. Section 801 of title 5, United States Code, and Executive Order 12866 requires certain regulatory assessments and procedures for any major rule or significant regulatory action, defined as one that would result in an annual effect of $100 million or more on the national economy or which would have other substantial impacts. The Regulatory Flexibility Act
(RFA)requires that each Federal agency prepare, and make available for public comment, a regulatory flexibility analysis when the agency issues a regulation which would have a significant impact on a substantial number of small entities. This is not a major rule under 5 U.S.C. 801. It is a significant regulatory action but not economically significant, and has been reviewed by the Office of Management and Budget as required under the provisions of E. O. 12866. In addition, we certify that this proposed rule will not significantly affect a substantial number of small entities. This final rule will not impose additional information collection requirements on the public under the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 55). List of Subjects in 32 CFR Part 199 Claims, Dental health, Health care, Health insurance, Individuals with disabilities, Military personnel. Accordingly, 32 CFR Part 199 is amended as follows: PART 199—[AMENDED] 1. The authority citation for Part 199 continues to read as follows: Authority: 5 U.S.C. 301; 10 U.S.C. chapter 55. 2. Section 199.3 is amended by revising paragraph (b)(2)(ii)(H)( *4* ) and by adding new paragraphs (b)(2)(iv), and (c)(9)(iii) to read as follows: § 199.3 Eligibility.
(b)* * *
(2)* * *
(ii)* * *
(H)* * *
(4)An unmarried person. An unmarried person placed in the home of a member or former member prior to adoption. To be a dependent child, the unmarried person must not have reached the age of 21 (or otherwise meets the requirements of a student or incapacitated child set out in paragraphs (b)(2)((ii)(H)( *1* ) or (b)(2)(ii)(H)( *2* ) of this section) and has been placed in the home of the member or former member by a recognized placement agency or by any other source authorized by State or local law to provide adoption placement, in anticipation of legal adoption by the member or former member.
(iv)An unmarried person who is placed in the legal custody of a member or former member by a court of competent jurisdiction in the United States (or possession of the United States) for a period of at least 12 consecutive months. The unmarried person shall be considered a dependent of the member or former member under this section provided he or she otherwise meets the following qualifications:
(A)Has not reached the age of 21 unless he or she otherwise meets the requirements of a student set out in paragraph (b)(2)(ii)(H)( *1* ) of this section or the requirements for being incapacitated as set out in paragraph (b)(2)(ii)(H)( *2* ) of this section and the incapacitation occurred while he or she was a dependent of the member or former member through court ordered legal custody;
(B)Is dependent on the member or former member for over one-half of the person's support;
(C)Resides with the member or former member unless separated by the necessity of military service or to receive institutional care as a result of disability or incapacitation or under such other authorized circumstances; and,
(D)Is not a dependent of a member or former member under any other provision of law or regulation.
(c)* * *
(9)* * *
(iii)Has been placed in the home of a member by a placement agency or by any other source authorized by State or local law to provide adoption placement, in anticipation of the legal adoption of the member:
(A)All benefits for which entitled, January 6, 2006.
(B)Extended Care Health Option benefits limited to children of members only, January 6, 2006. 3. Section 199.5 is amended by revising paragraphs (a)(2), (b)(1), and (f)(3)(i) to read as follows: § 199.5 TRICARE Extended Care Health Care Option (ECHO).
(a)* * *
(2)The purpose of the ECHO is to provide an additional financial resource for an integrated set of services and supplies designed to assist in the reduction of the disabling effects of the ECHO-eligible dependent's qualifying condition. Services include those necessary to maintain, minimize or prevent deterioration of function of an ECHO-eligible dependent.
(b)* * *
(1)The following categories of TRICARE/CHAMPUS beneficiaries with a qualifying condition are ECHO-eligible dependents:
(i)A spouse, child, or unmarried person (as described in § 199.3(b)(2)(i), (b)(2)(ii), or (b)(2)(iv)) of a member of the Uniformed Services on active duty for a period of more than 30 days.
(ii)An abused dependent as described in § 199.3(b)(2)(iii).
(iii)A spouse, child, or unmarried person (as described in § 199.3(b)(2)(i), (b)(2)(ii), or (b)(2)(iv)), of a member of the Uniformed Services who dies while on active duty for a period of more than 30 days and whose death occurs on or after October 7, 2001. In such case, an eligible surviving spouse remains eligible for benefits under the ECHO for a period of 3 years from the date the active duty sponsor dies. Any other eligible surviving dependent remains eligible for benefits under the ECHO for a period of three years from the date the active duty sponsor dies or until the surviving eligible dependent:
(A)Attains 21 years of age, or
(B)Attains 23 years of age or ceases to pursue a full-time course of study prior to attaining 23 years of age, if, at 21 years of age, the eligible surviving dependent is enrolled in a full-time course of study in a secondary school or in a full-time course of study in an institution of higher education approved by Secretary of Defense and was, at the time of the sponsor's death, in fact dependent on the member for over one-half of such dependent's support.
(iv)A spouse, child, or unmarried person (as defined in paragraphs § 199.3(b)(2)(i), (b)(2)(ii), or (b)(2)(iv)) of a deceased member of the Uniformed Services who, at the time of the member's death was receiving benefits under ECHO, and the member at the time of death was eligible for receipt of hostile-fire pay, or died as a result of a disease or injury incurred while eligible for such pay. In such a case, the surviving dependent remains eligible for benefits under ECHO through midnight of the dependent's twenty-first birthday.
(f)* * *
(3)* * *
(i)*ECHO* . The total Government share of the cost of all ECHO benefits, except ECHO Home Health Care
(EHHC)and EHHC respite care, provided in a given month to a beneficiary may not exceed $2,500 after application of the allowable payment methodology. 4. Section 199.17 is amended by: a. Redesignating paragraphs (c)(3) and (c)(4) as paragraphs (c)(4) and (c)(5) respectively. b. Adding new paragraph (c)(3). c. Revising paragraphs (g)(2) and (g)(3)(i) introductory text. d. Adding new paragraphs (g)(3)(i)(D) and (g)(3)(i)(E) to read as follows: § 199.17 TRICARE Program. *
(c)* * *
(3)*Survivors of Deceased Members.*
(i)The spouse of a member who dies while on active duty for a period of more than 30 days is eligible to enroll in Prime for a 3 year period beginning on the date of the member's death. For the three year period, surviving spouses of a member who dies while on active duty for a period of more than 30 days are subject to the same rules and provisions as dependents of active duty members.
(ii)A dependent child or unmarried person (as described in § 199.3(b)(2)(ii), or (b)(2)(iv)) of a member who dies while on active duty for a period of more than 30 days whose death occurred on or after October 7, 2001, is eligible to enroll in Prime and is subject to the same rules and provisions as dependents of active duty members for a period of three years from the date the active duty sponsor dies or until the surviving eligible dependent:
(A)Attains 21 years of age, or
(B)Attains 23 years of age or ceases to pursue a full-time course of study prior to attaining 23 years of age, if, at 21 years of age, the eligible surviving dependent is enrolled in a full-time course of study in a secondary school or in a full-time course of study in an institution of higher education approved by the Secretary of Defense and was, at the time of the sponsor's death, in fact dependent on the member for over one-half of such dependent's support.
(g)* * *
(2)*Active duty family member.* For purposes of this paragraph (g), the term “active duty family member” means one of the following dependents of an active duty member of the Uniformed Services:
(i)Spouse, child, or unmarried person, as defined in paragraphs § 199.3 (b)(2)(i), (b)(2)(ii) or (b)(2)(iv);
(ii)For a 3-year period, the surviving spouse of a member who dies while on active duty for a period of more than 30 days whose death occurred on or after October 7, 2001; and
(iii)The surviving dependent child or unmarried person, as defined in paragraphs § 199.3 (b)(2)(ii) or (b)(2)(iv), of a member who dies while on active duty for a period of more than 30 days whose death occurred on or after October 7, 2001. Active duty family member status is for a period of 3 years from the date the active duty sponsor dies or until the surviving eligible dependent:
(A)Attains 21 years of age, or
(B)Attains 23 years of age or ceases to pursue a full-time course of study prior to attaining 23 years of age, if, at 21 years of age, the eligible surviving dependent is enrolled in a full-time course of study in a secondary school or in a full-time course of study in an institution of higher education approved by the Secretary of Defense and was, at the time of the sponsor's death, in fact dependent on the member for over one-half of such dependent's support.
(3)*Eligibility.*
(i)An active duty family member is eligible for TRICARE Prime Remote for Active Duty Family Members if he or she is eligible for CHAMPUS and, on or after December 2, 2003, meets the criteria of (g)(3)(i)(A) and (g)(3)(i)(B) or (g)(3)(i)(C) of this section or on or after October 7, 2001, meets the criteria of (g)(3)(i)(D) or (g)(3)(i)(E) of this section:
(D)For a 3 year period, the surviving spouse of a member who dies while on active duty for a period of more than 30 days whose death occurred on or after October 7, 2001.
(E)The surviving dependent child or unmarried person as defined in paragraphs § 199.3 (b)(2)(ii) or (b)(2)(iv), of a member who dies while on active duty for a period of more than 30 days whose death occurred on or after October 7, 2001, for three years from the date the active duty sponsor dies or until the surviving eligible dependent: ( *1* ) Attains 21 years of age, or ( *2* ) Attains 23 years of age or ceases to pursue a full-time course of study prior to attaining 23 years of age, if, at 21 years of age, the eligible surviving dependent is enrolled in a full-time course of study in a secondary school or in a full-time course of study in an institution of higher education approved by the Secretary of Defense and was, at the time of the sponsor's death, in fact dependent on the member for over one-half of such dependent's support. Dated: January 10, 2007. L. M. Bynum, Alternate OSD Federal Register Liaison Officer, Department of Defense. [FR Doc. E7-709 Filed 1-18-07; 8:45 am] BILLING CODE 5001-06-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [CGD07-05-138] RIN 1625-AA11 Regulated Navigation Area: Savannah River, Savannah, GA AGENCY: Coast Guard, DHS. ACTION: Interim rule with request for comments. SUMMARY: On January 23, 2006, the Coast Guard published a notice of proposed rulemaking
(NPRM)to revise the regulated navigation area in Savannah, Georgia, to address changes in Liquefied Natural Gas
(LNG)tankship mooring locations following the creation of two new berths within a slip at the Southern LNG facility on the Savannah River. The previous rule only addressed facility and vessel requirements when an LNG vessel was underway or was moored parallel to the navigational channel outside of the slip. This interim rule describes requirements for three different potential mooring situations following the expansion: an LNG tankship moored outside of the slip, one or more LNG tankships moored inside the slip, and LNG tankships moored both inside and outside of the slip. This interim rule will become effective on February 20, 2007. However, we still encourage you to participate in this rulemaking by submitting comments and related material to the docket. We will accept comments for 60 days from the date this rule is published in the **Federal Register** , after which we intend to publish a final rule. Any comments received will be considered in the final rule. This interim rule is necessary to ensure safe navigation of the Savannah River and the safe transfer of LNG in the Port of Savannah. DATES: This interim rule is effective February 20, 2007. Comments and related material must reach the Coast Guard on or before March 20, 2007. ADDRESSES: Comments and material received from the public, as well as documents indicated in this preamble as being available in the docket [CGD07-05-138], will become part of this docket and will be available for inspection or copying at Marine Safety Unit Savannah, Gordon Low Federal Building, Suite 1017, 100 W. Oglethorpe, Savannah, Georgia 31401, between 7:30 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Lieutenant Robert Webb, Waterways Management Officer, Marine Safety Unit Savannah;
(912)652-4353. SUPPLEMENTARY INFORMATION: Regulatory Information On January 23, 2006, we published a notice of proposed rulemaking
(NPRM)entitled “Regulated Navigation Area: Savannah River, Savannah, GA” (71 FR 3442). To ensure the safe transfer of liquefied Natural Gas in the port of Savannah, we are publishing this interim rule that will become effective February 20, 2007. However, we still encourage you to participate in this rulemaking by submitting comments and related material to the docket. We will accept comments for 60 days after which we intend to consider received comments and publish a final rule. If you submit comments, please include your name and address, identify the docket number for this rulemaking [CGD07-05-138], indicate the specific section of this document to which each comment applies, and give the reason for each comment. Please submit all comments and related material in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying. If you would like to know they reached us, 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 interim rule in view of them. Public Meeting We do not plan to hold a public meeting on the interim rule. But you may submit a request for a meeting by writing to MSU Savannah (see ADDRESSES above) explaining why one would be beneficial. If we determine that one would aid this rulemaking, we will hold one at the time and place announced by a later notice in the **Federal Register** . We did not receive a request for a public meeting in response to the notice of proposed rulemaking and we did not hold a public meeting. Background and Purpose In May of 2002, Southern LNG Inc. submitted a letter of intent to expand the LNG facility on Elba Island that would nearly double LNG storage capacity and substantially increase the number of LNG tankship arrivals. The Coast Guard's positive endorsement was contingent upon the relocation of the primary LNG mooring facility in order to reduce the risk of allision and subsequent breaching of an LNG tankship's cargo tank(s). To meet this Coast Guard requirement, Southern LNG Inc. initiated a project to create a protected docking slip designed to allow simultaneous LNG transfers from vessels. This expansion, completed early in 2006, significantly reduced the level of risk associated with LNG tankship operations and vessels passing by the LNG facility. This interim rule addresses the three possible tankship mooring configurations now available to LNG tankships. The three possible tankship mooring configurations available to LNG tankships are LNG vessels moored inside the slip, outside the slip, and a combination of inside and outside the slip. Discussion of Comments and Changes to the Proposed Rule A single commentor submitted several comments to the Coast Guard during the NPRM comment period (71 FR 3442). Several comments stated that the requirement for standby tugs should be eliminated as unnecessarily duplicative of the new slip and the infrastructure and procedures already in place to prevent an LNG spill. The Coast Guard does not believe the use of standby tugs is duplicative. The use of standby tugs to attend moored LNG vessels is a common practice in the LNG industry with the tugs having the general duties of providing a ready means of assistance to maintain a safe area around the LNG vessel, provide emergency firefighting assistance, and aid the LNG vessel in the event of an emergency departure. For example, Coast Guard Sector Baltimore requires one tractor tug to be on scene and two tractor tugs to be on a 10-minute standby. Also, the vessel operators and/or LNG facility in the ports of Lake Charles and Ponce, Louisiana, require standby tugs although there is no Coast Guard requirement. Due to the Southern LNG facility's location on the Savannah River, approximately 8 nautical miles from the busiest area of the port, it is unlikely that tug assistance could arrive in a reasonable amount of time or guarantee that they would be available at all in the event of an emergency if tugs are not dedicated to standby duties in the immediate vicinity of the moored LNG tankship. Therefore, the requirement for two standby towing vessels to take appropriate actions in an emergency remains. Additionally, the definition of standby was slightly modified to mean readily available at the facility and equipped to provide a ready means of assistance to maintain a safe zone around LNG tankships, provide emergency firefighting assistance, and aid the LNG tankship in the event of an emergency departure. This change makes it clear that the standby towing vessels should remain at the facility unless they are assisting a passing vessel in distress. A requirement for at least one LNG escort towing vessel and at least one standby towing vessel to be FiFi Class 1 equipped was added to ensure adequate fire fighting capabilities. In the case where one LNG tankship is moored at the facility and another LNG tankship is inbound to the facility, one FiFi Class 1 equipped towing vessel shall remain at the facility along with another standby towing vessel not so equipped while another FiFi Class 1 equipped towing vessel shall escort the inbound LNG tankship to the facility along with another escort towing vessel not so equipped. The Coast Guard believes this requirement produces the least risk to the port and takes into account the limited local availability of FiFi Class 1 equipped towing vessels. The requirement for a third towing vessel is eliminated when vessels are moored within the LNG facility slip. Three comments from the commentor stated that the Southern LNG facility is a receiving terminal only and that the “marine-side” services, such as docking, line handling, search and rescue, and towing are specifically not provided under the LNG facility tariff on file with the Federal Energy Regulatory Commission (FERC). Therefore, the LNG facility should not be held responsible for providing the towing vessels required by this regulation. The Coast Guard has changed the rule to specify that an LNG tankship must have towing vessels on-scene when moored at an LNG facility. The provisions in section 165.756(d) are no longer directed at LNG facility operators. These changes provide greater consistency with other provisions in Part 165. Three comments from the commentor noted that the duties of the standby towing vessels outlined in paragraph (d)(3) of 33 CFR 165.756 are vague. The Coast Guard agrees with this assertion and has added the following language to the definition for stand-by , “means readily available at the facility and equipped to provide a ready means of assistance to maintain a safe zone around the moored LNG tankship, to provide emergency firefighting assistance, to aid the LNG tankship in the event of an emergency departure, or to take other appropriate actions in an emergency as necessary.” To clearly outline the type of towing vessels that are required for the standby duties described in this regulation, additional language was also added to outline the minimum firefighting capabilities of at least one of the standby towing vessels. Two comments from the commentor stated that moving the LNG vessels from the river pier to the protected LNG facility slip has made the standby towing vessels unnecessary because the new mooring configuration has eliminated the potential for a passing vessel to allide with a moored LNG tankship causing an LNG spill. The Coast Guard carefully considered this assessment and disagrees. Although the risk has been reduced, there is still a risk of allision while LNG tankships are moored within the LNG facility slip. If a passing vessel loses power and/or steering, it is possible for it to enter the slip and allide with the moored LNG tankship. The existence of the two standby towing vessels allows the passing vessel in distress to request immediate assistance that may prevent an allision and possible LNG spill. Additionally, the standby towing vessels provide a ready means of assistance to maintain a safe area around the LNG vessel, provide emergency firefighting assistance, and aid the LNG vessel in the event of an emergency departure. Therefore, the requirement for two standby towing vessels remains. One comment from the commentor stated the standby towing vessels are not needed to prevent ranging of the LNG tankship at its mooring due to the surge caused by a passing vessel. This assertion was recently proven false when the surge created by a large vessel passing the LNG facility slip at excessive speed caused a moored LNG tankship to range and resulted in the emergency shutdown of the LNG transfer and caused several of the LNG tankship's mooring lines to break. Automatic emergency shutoffs prevented the release of LNG and the standby tugs immediately assisted the LNG tankship back to its original position where it was secured with additional mooring lines. While this occurrence may be unusual, it illustrates that standby towing vessels are valuable assets in the event of an emergency. This occurrence adds support to our decision to keep the requirement for two standby towing vessels. One comment from the commentor stated that the Coast Guard should monitor the speed of passing vessels through a remote monitoring system such as the Automated Information System (AIS). At this time, the local Coast Guard shore units cannot access the AIS information and do not have sufficient personnel resources to monitor such a system on a 24 hour basis. However, the incident described in the above paragraph highlights the risk posed by vessels passing the LNG facility slip at excessive speed. Therefore the “minimum safe speed” language in paragraph (d)(5)(ii) of the proposed rule has been replaced with “bare steerage way” in paragraph (d)(6)(iv) of the interim rule to eliminate any confusion that passing vessels must make every effort to minimize their surge as they pass the LNG facility slip were an LNG tankship is moored. One comment stated that the requirement for emergency towing wires, also known as fire wires, apply only to LNG tankships moored at the river dock. The Coast Guard disagrees with this comment and the requirement for emergency towing wires remains in all mooring configurations unless the LNG tankship is equipped with waterline bollards. Language was added that exempts LNG tankships equipped with waterline bollards from this requirement. The Coast Guard believes that waterline bollards provide an equivalent level of safety and allow for standby towing vessels to quickly “make-up” to an LNG tankship in the event of an emergency. One comment from the commentor stated that the standby towing vessels are not necessary to assist in the emergency departure of a moored LNG tankship from the slip because the LNG tankship will likely be safest at its mooring even in the event of an emergency within the facility. The Coast Guard disagrees with this assertion. Industry publications state that in the case of an internal emergency within the terminal, it is often good practice to remove ships from the berths in order to avoid their possible involvement in the situation. Such emergencies may include a fire on the facility or an imminent terrorist threat to the facility that may prompt the Captain of the Port or the master of an LNG tankship to order departure of the vessel from the LNG facility slip or pier immediately. Therefore, the requirement for two standby towing vessels remains. One additional comment from the commentor requested relief from the towing vessel escort requirements for an outbound vessel in a “heel” condition. The Coast Guard carefully considered this request and believes that LNG vessels carrying only “heel” pose a minimal risk of an LNG spill. Therefore, we included language in the interim rule that removes the requirement to escort LNG vessels in heel when transiting within the Regulated Navigation Area. The definition of heel “is the minimum quantity of liquefied natural gas
(LNG)retained in an LNG tankship after unloading at the LNG facility to maintain temperature, pressure, and/or prudent operations. [A] quantity of LNG less than five percent (5%) of the LNG tankship's carrying capacity shall be presumed to be heel.” This same reasoning led us to remove the restrictions on other vessels while the LNG tankship is outbound in a heel condition. Vessels over 200 gross tons will have a pilot aboard who will know that the outbound LNG tankship is in a heel condition. All other vessels will follow the navigation rules and treat the outbound LNG vessel just as any other deep-draft vessel transiting the Savannah River. Finally, several comments by the commentor also included support for the provisions in the proposed rule. One comment supported keeping unnecessary vessels out of the LNG facility slip. This provision remains in the interim rule. One comment supported limiting passing vessels to minimum safe speed. This provision remains in the interim rule, but the language was changed to “bare steerage way” to eliminate any confusion over a definition of “minimum safe speed.” One comment supported eliminating broadcast notices of LNG transits. This provision remains in the interim rule. One comment supported allowing oral waivers. This provision also remains in the interim rule. Discussion of Interim Rule The interim rule accounts for all three potential mooring arrangements within the LNG facility slip. All of these requirements are needed to reduce the risk associated with marine LNG transfer operations. On-scene standby towing vessels will allow for immediate action in an emergency involving an LNG tankship, the LNG facility, or a vessel passing a moored LNG tankship conducting transfer operations. They will also be available to provide a ready means of assistance to maintain a safe zone around a moored carrier and to provide emergency firefighting support in the event of a fire. When an LNG tankship is moored outside of the slip, the towing vessel requirement of 3 towing vessels as outlined in the Notice of Proposed Rulemaking published in January 2006 remains unchanged. Additionally, the LNG tankship will be required to provide at least one standby towing vessel with a minimum of 90,000 pounds of bollard pull to take appropriate actions in an emergency as directed by the LNG vessel bridge watch. However, one of the two escort towing vessels shall be FiFi Class 1 equipped, and the escort towing vessels shall have a minimum capacity of 100,000 pounds of bollard pull, 4,000 horsepower and capable of safely operating in the indirect mode in order to escort transiting vessels 1,600 gross tons or greater past the moored LNG tankship. When an LNG tankship is moored inside the new slip, the requirement for tethered escorts is removed. However, an LNG tankship will still be required to have two standby towing vessels with a minimum capacity of 100,000 pounds of bollard pull, 4,000 horsepower, and the ability to operate safely in the indirect mode in order to take appropriate actions in an emergency. At least one of these standby towing vessels shall be FiFi Class 1 equipped. These on scene towing vessels shall respond to any emergency situation for the LNG tankship moored within the slip occurring at the facility or caused by vessels transiting the Savannah River past the LNG facility. When two LNG tankships are moored inside the slip each vessel shall provide a standby towing vessel that is FiFi class 1 equipped with a minimum capacity of 100,000 pounds of bollard pull and 4,000 horsepower. When an LNG tankship is moored inside the new slip and another LNG tankship is moored outside of the slip, a minimum of three towing vessels are required. The LNG tankship moored outside the slip shall provide two escort towing vessels each with a minimum of 100,000 pounds of bollard pull, 4,000 horsepower and capable of safely operating in the indirect mode in order to escort transiting vessels 1,600 gross tons or greater past the moored LNG tankship. The LNG tankship moored inside the slip shall have at least one standby towing vessel with a minimum of 100,000 pounds of bollard pull, 4,000 horsepower and FiFi Class 1 equipped to take appropriate actions in an emergency as directed by the LNG vessel bridge watch. When one LNG tankship is moored outside and two LNG tankships are moored inside the LNG facility slip, the LNG tankship moored outside of the LNG facility slip shall have on-scene a minimum of two escort towing vessels each with a minimum of 100,000 pounds of bollard pull, 4,000 horsepower and capable of safely operating in the indirect mode in order to escort transiting vessels 1,600 gross tons or greater past the moored LNG tankship. At least one of these towing vessels shall be FiFi Class 1 equipped. In addition, the LNG tankships moored inside of the slip shall have at least one standby towing vessel between the two ships with a minimum of 100,000 pounds of bollard pull, 4,000 horsepower and FiFi Class 1 equipped to take appropriate actions in an emergency as directed by the LNG vessel bridge watch. Security operations have been added to the list of operations that are exempt from the applicability of this rule. This will allow facility owned or operated security vessels and local state and local law enforcement vessels to operate freely within the RNA. To limit delays to other vessels operating within the RNA, § 165.756(d)(1)(i) has been slightly modified to allow vessels of 1,600 gross tons or greater to pass the facility while the LNG tankships are maneuvering and mooring, as long as the LNG vessels are outside of the Savannah River shipping channel (i.e., inside of the slip) and the other ships are proceeding past the slip at bare steerage way. In the interest of security, paragraph (d)(1)(iii)(C) was removed because it drew undue attention to LNG tankships transiting the area without increasing navigational safety. However, new language has been added for vessels 1,600 gross tons or greater while in the RNA to make a broadcast on channel 13 at the following points on the Savannah River:
(a)Buoy “33” in the vicinity of Fields Cut for inbound vessels and
(b)Buoy “53” in the vicinity of Fort Jackson for outbound vessels. This language was added to improve communications in the interest of safety and to reduce the risk of damage to moored LNG vessels or the facility due to surge or casualty of passing vessels. The subsequent paragraphs have been appropriately redesignated. A requirement for emergency towing wires (fire wires) was added in paragraph (d)(5)(ii) to follow standard industry practice and ensure the vessels are immediately available for emergency towing. LNG vessels equipped with waterline bollards are exempt from this requirement. Due to anticipated and observed hydrodynamic effects on the water within the LNG slip, vessel operating restrictions were added in paragraph (d)(6)(iv) to ensure safe LNG transfer operations. In the interest of safety and security, paragraph (d)(6)(vii) was added to prevent unnecessary vessels from entering the LNG slip. In the interest of port security, this interim rule also eliminates the Captain of the Port requirement to issue a Broadcast Notice to Mariners on scheduled LNG tankship activities during which the restrictions imposed by this section are in effect. The level of safety introduced by broadcasting LNG tankship schedules to the general public via marine radio does not outweigh the potential security impacts. River pilots who operate all vessels over 200 gross tons on the Savannah River are well aware of the LNG tankship transit times. While transiting within the RNA, the LNG tankships carrying LNG in excess of heel will be escorted by towing vessels and security vessels that can effect notice of this rule to any vessels not requiring a river pilot. To further define when the RNA is in effect the following was added to paragraph
(a)of the proposed rule, “when a LNG tankship in excess of heel is transiting the area or moored at the LNG facility.” To ensure the timeliness of response operations and maximize safety and security, the waiver authority in this rule has been modified to allow verbal or written waivers by the Captain of the Port to the requirements of this rule. Administrative Procedure Act We are making this interim rule effective 30 days after publication in the **Federal Register** . Delaying implementation of this rule any longer to await public notice and comment would be contrary to the public interest because of the adverse effect on the safety of navigation in the Savannah River, vessel congestion, and the safety and security of LNG transfer operations in the port. However, we want to receive comments on the changes from the proposed rule before issuing a final rule. Please submit your comment on this interim rule on or before March 20, 2007. We may revise the rule based on your comments. 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. It is not significant under the regulatory policies and procedures of the Department of Homeland Security. Delays for inbound and outbound traffic due to LNG transits will be reduced through this interim rule and through pre-transit conferences between the pilots and the Coast Guard Captain of the Port. Additional financial benefits of this rule are that LNG tankships transiting in heel will not be required to have two escort towing vessels and LNG tankships moored only inside the LNG facility slip will only be required to provide 2 standby towing vessels vice the current requirement of 3 towing vessels. The requirement of having one of the escort towing vessels be FiFi Class 1 equipped does not impose an additional financial burden due to a FiFi Class 1 escort towing vessel is currently being utilized for this purpose. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this 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 LNG facility does not qualify as a small entity. Towing vessels may qualify as small entities; however the economic impact incurred will be borne by the LNG tankships. 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. Delays for inbound and outbound traffic due to LNG transits will be minimized through this change and through pre-transit conferences between the pilots and the Coast Guard Captain of the Port. The RNA requirements are less burdensome for smaller vessels, which are more likely to be small entities; however, there would not be a significant economic impact. If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have 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 (Pubic Law 104-121), we want to assist small entities in understanding this proposal so that they could better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business and you have questions concerning its provisions or options for compliance, please contact the person listed under FOR FURTHER INFORMATION CONTACT . Small businesses may also 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). 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 interim rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This rule would 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 does not create an environmental risk to health or risk to safety that might 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 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. 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. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs 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 We have analyzed this rule under Commandant Instruction M16475.lD and Department of Homeland Security Management Division 5100.0, 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. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES . List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and record keeping requirements, 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. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 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. Revise § 165.756 to read as follows: § 165.756 Regulated Navigation Area; Savannah River, Georgia.
(a)*Regulated Navigation Area (RNA).* The Savannah River between Fort Jackson (32°04.93′ N, 081°02.19′ W) and the Savannah River Channel Entrance Sea Buoy is a regulated navigation area when an LNG tankship in excess of heel is transiting the area or moored at the LNG facility. All coordinates are North American Datum 1983.
(b)*Definitions.* The following definitions apply to this section: *Bare Steerage Way* means the minimum speed necessary for a ship to maintain control over its heading. *Bollard pull* means an industry standard used for rating tug capabilities and is the pulling force imparted by the tug to the towline. It means the power that an escort tug can apply to its working line(s) when operating in a direct mode. *Direct Mode* means a towing technique defined as a method of operation by which a towing vessel generates towline forces by thrust alone at an angle equal to or nearly equal to the towline, or thrust forces applied directly to the escorted vessel's hull. *Fire Wire* means a length of wire rope or chain hung from the bow and stern of a vessel in port to allow the vessel to be towed away from the pier in case of fire; also called fire warp or emergency towing wire. *Heel* means the minimum quantity of liquefied natural gas
(LNG)retained in an LNG tankship after unloading at the LNG facility to maintain temperature, pressure, and/or prudent operations. A quantity of LNG less than five percent (5 %) of the LNG tankship's carrying capacity shall be presumed to be heel. *Indirect Mode* means a towing technique defined as a method of operation by which an escorting towing vessel generates towline forces by a combination of thrust and hydrodynamic forces resulting from a presentation of the underwater body of the towing vessel at an oblique angle to the towline. This method increases the resultant bollard pull, thereby arresting and controlling the motion of an escorted vessel. *LNG tankship* means a vessel as described in 46 CFR 154. *Made-up* means physically attached by cable, towline, or other secure means in such a way as to be immediately ready to exert force on a vessel being escorted. *Make-up* means the act of, or preparations for becoming made-up. *Operator* means the person who owns, operates, or is responsible for the operation of a facility or vessel. *Savannah River Channel Entrance Sea Buoy* means the aid to navigation labeled R W “T” Mo
(A)WHIS on the National Oceanic and Atmospheric Administration's
(NOAA)Nautical Chart 11512. *Standby* means readily available at the facility and equipped to provide a ready means of assistance to maintain a safe zone around LNG tankships, provide emergency firefighting assistance, and aid the LNG tankship in the event of an emergency departure. *Underway* means that a vessel is not at anchor, not made fast to the shore, or not aground.
(c)*Applicability.* This section applies to all vessels operating within the RNA, including naval and other public vessels, except vessels that are engaged in the following operations:
(1)Law enforcement, security, or search and rescue;
(2)Servicing aids to navigation;
(3)Surveying, maintenance, or improvement of waters in the RNA; or
(4)Actively engaged in escort, maneuvering, or support duties for an LNG tankship.
(d)*Regulations* —(1) *Requirements for vessel operations while a LNG tankship, carrying LNG in excess of heel, is underway within the RNA.*
(i)Except for a vessel that is moored at a marina, wharf, or pier, and remains moored, no vessel 1,600 gross tons or greater may come within two nautical miles of a LNG tankship, carrying LNG in excess of heel, which is underway within the Savannah River shipping channel without the permission of the Captain of the Port (COTP).
(ii)All vessels less than 1,600 gross tons shall keep clear of transiting LNG tankships.
(iii)The owner, master, or operator of a vessel carrying liquefied natural gas
(LNG)shall:
(A)Comply with the notice requirements of 33 CFR part 160. The COTP may delay the vessel's entry into the RNA to accommodate other commercial traffic.
(B)Obtain permission from the COTP before commencing the transit into the RNA.
(C)Not enter or get underway within the RNA if visibility during the transit is not sufficient to safely navigate the channel, and/or wind speed is, or is expected to be, greater than 25 knots.
(D)While transiting the RNA, the LNG tankship, carrying LNG in excess of heel, shall have a minimum of two escort towing vessels with a minimum of 100,000 pounds of bollard pull, 4,000 horsepower and capable of safely operating in the indirect mode. At least one of the towing vessels shall be FiFi Class 1 equipped.
(2)*Requirements while an LNG tankship is moored outside of the LNG facility slip* —(i) An LNG tankship moored outside of the LNG facility slip shall have on-scene a minimum of two escort towing vessels each with a minimum of 100,000 pounds of bollard pull, 4,000 horsepower and capable of safely operating in the indirect mode in order to escort transiting vessels 1,600 gross tons or greater past the moored LNG tankship. At least one of these towing vessels shall be FiFi Class 1 equipped.
(ii)In addition to the two towing vessels required by paragraph (d)(2)(i) of this section, the LNG tankship moored outside of the slip shall have at least one standby towing vessel with a minimum of 90,000 pounds of bollard pull to take appropriate actions in an emergency as directed by the LNG vessel bridge watch required in paragraph (d)(5) of this section.
(3)*Requirements while LNG tankships are moored inside the LNG facility slip* —(i) An LNG tankship moored inside the LNG facility slip shall have two standby towing vessels with a minimum capacity of 100,000 pounds of bollard pull, 4,000 horsepower, and the ability to operate safely in the indirect mode. At least one of these towing vessels shall be FiFi Class 1 equipped. The standby towing vessels shall take appropriate action in an emergency as directed by the LNG vessel bridge watch required in paragraph (d)(5) of this section.
(ii)If two LNG tankships are moored inside the LNG facility slip, each vessel shall provide a standby towing vessel that is FiFi class 1 equipped with a minimum capacity of 100,000 pounds of bollard pull and 4,000 horsepower that is available to assist as directed by the LNG vessel bridge watch required in paragraph (d)(5) of this section.
(4)*Requirements while LNG tankships are moored both inside the LNG facility slip and outside the LNG facility slip* —(i) When one LNG tankship is moored inside and one LNG tankship is moored outside of the LNG facility slip, the LNG tankship moored outside of the LNG facility slip shall have on-scene a minimum of two escort towing vessels each with a minimum of 100,000 pounds of bollard pull, 4,000 horsepower and capable of safely operating in the indirect mode in order to escort transiting vessels 1,600 gross tons or greater past the moored LNG tankship. At least one of these towing vessels shall be FiFi Class 1 equipped. In addition, the LNG tankship moored inside of the slip shall have at least one standby towing vessel with a minimum of 100,000 pounds of bollard pull, 4,000 horsepower and FiFi Class 1 equipped to take appropriate actions in an emergency as directed by the LNG vessel bridge watch required in paragraph (d)(5) of this section.
(ii)When one LNG tankship is moored outside and two LNG tankships are moored inside the LNG facility slip, the LNG tankship moored outside of the LNG facility slip shall have on-scene a minimum of two escort towing vessels each with a minimum of 100,000 pounds of bollard pull, 4,000 horsepower and capable of safely operating in the indirect mode in order to escort transiting vessels 1,600 gross tons or greater past the moored LNG tankship. At least one of these towing vessels shall be FiFi Class 1 equipped. In addition, the LNG tankships moored inside of the slip shall have at least one standby towing vessel between the two ships with a minimum of 100,000 pounds of bollard pull, 4,000 horsepower and FiFi Class 1 equipped to take appropriate actions in an emergency as directed by the LNG vessel bridge watch required in paragraph (d)(5) of this section.
(iii)In the event of an actual emergency, escort towing vessels can be utilized as stand-by towing vessels to take appropriate actions as directed by the LNG vessel bridge watch required in paragraph (d)(5) of this section.
(5)*Requirements for moored LNG tankships* —(i) While moored within the RNA, each LNG tankship shall maintain a bridge watch consisting of a docking pilot or licensed deck officer who shall monitor all vessels transiting past the LNG facility. In addition, the LNG Bridge Watch shall communicate with the pilots of vessels greater than 1600 gross tons at the points identified in section (d)(6)(iii) of this section prior to passing the LNG facility in order to take actions of the towing vessel(s) required in paragraphs (d)(2) through
(4)of this section.
(ii)While moored within the RNA, LNG tankships shall have emergency towing wires (fire wires) positioned one meter above the waterline, both on the off-shore bow and quarter of the ship. LNG vessels equipped with waterline bollards are exempt from this requirement.
(6)*Requirements for other vessels while within the RNA* —(i) Transiting vessels 1,600 gross tons or greater, when passing an LNG tankship moored outside of the LNG facility slip, shall have a minimum of two towing vessels with a minimum capacity of 100,000 pounds of bollard pull, 4,000 horsepower, and the ability to operate safely in the indirect mode, made-up in such a way as to be immediately available to arrest and control the motion of an escorted vessel in the event of steering, propulsion or other casualty. At least one of the towing vessels shall be FiFi Class 1 equipped. While it is anticipated that vessels will utilize the towing vessel services required in paragraphs (d)(2)(i) and (d)(4)(i) of this section, this section does not preclude escorted vessel operators from providing their own towing vessel escorts, provided they meet the requirements of this part.
(A)Outbound vessels shall be made-up and escorted from Bight Channel Light 46 until the vessel is safely past the LNG dock.
(B)Inbound vessels shall be made-up and escorted from Elba Island Light 37 until the vessel is safely past the LNG dock.
(ii)The requirements in paragraph (d)(6)(i) of this section do not apply when one or more LNG tankships are moored in the LNG facility slip and no LNG tankship is moored at the pier outside of the LNG facility slip.
(iii)Vessels 1,600 gross tons or greater shall make a broadcast on channel 13 at the following points on the Savannah River:
(A)Buoy “33” in the vicinity of Fields Cut for inbound vessels;
(B)Buoy “53” in the vicinity of Fort Jackson for outbound vessels.
(iv)Vessels 1,600 gross tons or greater shall at a minimum, transit at bare steerageway when within an area 1,000 yards on either side of the LNG facility slip to minimize potential wake or surge damage to the LNG facility and vessel(s) within the slip.
(v)Vessels 1,600 gross tons or greater shall not meet nor overtake within an area 1,000 yards on either side of the LNG facility slip when an LNG tankship is present within the slip.
(vi)All vessels less than 1,600 gross tons shall not approach within 70 yards of an LNG tankship, carrying LNG in excess of heel, without the permission of the Captain of the Port.
(vii)Except for vessels involved in those operations noted in paragraph
(c)of this section entitled Applicability, no vessel shall enter the LNG facility slip at any time without the permission of the Captain of the Port.
(e)*Waivers.*
(1)The COTP may waive any requirement in this section, if the COTP finds that it is in the best interest of safety or in the interest of national security. Such waivers may be verbal or in writing.
(2)An application for a waiver of these requirements must state the compelling need for the waiver and describe the proposed operation and methods by which adequate levels of safety are to be obtained.
(f)*Enforcement.* Violations of this section should be reported to the Captain of the Port, Savannah, at
(912)652-4353. In accordance with the general regulations in § 165.13 of this part, no person may cause or authorize the operation of a vessel in the regulated navigation area contrary to the provisions of this section. Dated: January 5, 2007. D. W. Kunkel, Rear Admiral, U.S. Coast Guard, Commander, Seventh Coast Guard District. [FR Doc. E7-728 Filed 1-18-07; 8:45 am] BILLING CODE 4910-15-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 300 [EPA-HQ-SFUND-1986-0005; FRL-8271-2] National Oil and Hazardous Substance Pollution Contingency Plan; National Priorities List AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final notice of deletion of the Avenue E Groundwater Contamination Superfund Site from the National Priorities List. SUMMARY: The Environmental Protection Agency (EPA), Region V is publishing a direct final notice of deletion of the Avenue E Groundwater Contamination Superfund Site (Site), located in Traverse City, Michigan from the National Priorities List (NPL). The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is appendix B of 40 CFR part 300, which is the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). This direct final deletion is being published by EPA with the concurrence of the State of Michigan, through the Michigan Department of Environmental Quality (MDEQ), because EPA has determined that all appropriate response actions under CERCLA have been completed, and, therefore, further remedial action pursuant to CERCLA is not necessary at this time. DATES: This direct final notice of deletion will be effective March 20, 2007 unless EPA receives adverse comments by February 20, 2007. If adverse comments are received, EPA will publish a timely withdrawal of the direct final notice of deletion in the **Federal Register** informing the public that the deletion will not take effect. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-SFUND-1986-0005 by one of the following methods: • *http://www.regulations.gov:* Follow the on-line instructions for submitting comments. • *E-mail:* *beard.gladys@epa.gov.* • *Fax:* Gladys Beard at
(312)886-4071. • *Mail:* Dave Novak, Community Involvement Coordinator, U.S. EPA (P-19J), 77 W. Jackson, Chicago, Il 60604, 312-886-0269 or 1-800-621-8431. • *Hand Delivery:* Dave Novak, Community Involvement Coordinator, (P-19J), 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-HQ-SFUND-1986-0005. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *http://www.regulations.gov,* including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *http://www.regulations.gov* or e-mail. The *http://www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *http://www.regulations.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. For additional instructions on submitting comments, go to Section I of the SUPPLEMENTARY INFORMATION section of this document. *Docket:* All documents in the docket are listed in the *http://www.regulations.gov* index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *http://www.regulations.gov* or in hard copy at the Environmental Protection Agency, Region 5, Superfund Division, 77 West Jackson Boulevard, Chicago, Illinois 60604. This Facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. We recommend that you telephone Gladys Beard, State NPL Deletion Process Manager at
(312)886-7253, before visiting the Region 5 office. *Information Repositories:* Comprehensive information about the Site is available for viewing and copying at the Site information repositories located at: EPA Region V Record Center, 77 W. Jackson, Chicago, Il 60604,
(312)353-5821, Monday through Friday 8:30 a.m. to 4:30 p.m. FOR FURTHER INFORMATION CONTACT: Linda Martin, Remedial Project Manager at
(312)886-3854, *Martin.Lindab@epa.gov* or Gladys Beard, State NPL Deletion Process Manager at
(312)886-7253, *Beard.Gladys@epa.gov* or 1-800-621-8431, (SR-6J), U.S. EPA Region V, 77 W. Jackson, Chicago, IL 60604. SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction II. NPL Deletion Criteria III. Deletion Procedures IV. Basis for Site Deletion V. Deletion Action I. Introduction EPA Region V is publishing this direct final notice of deletion of the Avenue E Groundwater Contamination Superfund Site from the NPL. The EPA identifies sites that appear to present a significant risk to public health or the environment and maintains the NPL as the list of those sites. As described in section 300.425(e)(3) of the NCP, sites deleted from the NPL remain eligible for remedial actions if conditions at a deleted site warrant such action. Because EPA considers this action to be non-controversial and routine, EPA is taking it without prior publication of a notice of intent to delete. This action will be effective March 20, 2007 unless EPA receives adverse comments by February 20, 2007 on this document. If adverse comments are received within the 30-day public comment period on this document, EPA will publish a timely withdrawal of this direct final deletion before the effective date of the deletion and the deletion will not take effect. EPA will, as appropriate, prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment. Section II of this document explains the criteria for deleting sites from the NPL. Section III discusses procedures that EPA is using for this action. Section IV discusses the Avenue E Groundwater Superfund Site and demonstrates how it meets the deletion criteria. Section V discusses EPA's action to delete the Site from the NPL unless adverse comments are received during the public comment period. II. NPL Deletion Criteria Section 300.425(e) of the NCP provides that releases may be deleted from the NPL where no further response is appropriate. In making a determination to delete a release from the NPL, EPA shall consider, in consultation with the State, whether any of the following criteria have been met: i. Responsible parties or other persons have implemented all appropriate response actions required; ii. All appropriate Fund-financed (Hazardous Substance Superfund Response Trust Fund) responses under CERCLA have been implemented, and no further response action by responsible parties is appropriate; or iii. The remedial investigation has shown that the release poses no significant threat to public health or the environment and, therefore, the taking of remedial measures is not appropriate. Even if a site is deleted from the NPL, where hazardous substances, pollutants, or contaminants remain at the deleted site above levels that allow for unlimited use and unrestricted exposure, CERCLA section 121(c), 42 U.S.C. 9621(c), requires that a subsequent review of the site be conducted at least every five years after the initiation of the remedial action at the deleted site to ensure that the action remains protective of public health and the environment. If new information becomes available which indicates a need for further action, EPA may initiate remedial actions. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system. III. Deletion Procedures The following procedures apply to deletion of this Site:
(1)The EPA consulted with the State of Michigan on the deletion of the Site from the NPL prior to developing this direct final notice of deletion.
(2)Michigan concurred with deletion of the Site from the NPL.
(3)Concurrently with the publication of this direct final notice of deletion a notice of intent to delete is published today in the “Proposed Rules” section of the **Federal Register** , is being published in a major local newspaper of general circulation at or near the Site, and is being distributed to appropriate federal, state, and local government officials and other interested parties. The newspaper notice announces the 30-day public comment period concerning the notice of intent to delete the Site from the NPL.
(4)The EPA placed copies of documents supporting the deletion in the site information repositories identified above.
(5)If adverse comments are received within the 30-day public comment period on this document, EPA will publish a timely notice of withdrawal of this direct final notice of deletion before its effective date and will prepare a response to comments and continue with a decision on the deletion based on the notice of intent to delete and the comments already received. Deletion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a site from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist EPA management. Section 300.425(e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for future response actions should future conditions warrant such actions. IV. Basis for Site Deletion The remedy at the Avenue E Site was found to be protective of human health and the environment. This determination was documented in the five year review conducted in 2005. All groundwater contaminants associated with the Coast Guard facility have reached the clean up standards specified in the 1987 agreement between the Coast Guard and the State of Michigan. All active remediation has been completed and no further actions are required for this Site. The following sections outline additional information reviewed as part of an NPL deletion determination. Site Location The Avenue E Groundwater Contamination Superfund Site was a groundwater contamination plume located in East Bay Township in Traverse County, Traverse City, Michigan. The source of the contamination was located on the U.S. Coast Guard
(USCG)Air Station. The plume was located west of the intersection of Parsons Road and Aero Park Drive. It was traced to the northwest corner of an industrial park back lot located southwest of Nish-Nah-Bee Industries. The plume eventually extended to the East Arm of the Grand Traverse Bay. Site History In 1980, residents of Avenue E in East Bay Township complained of odors and foaming in their well water. Subsequent investigation by the Michigan Department of Public Health
(MDPH)and the Michigan Department of Natural Resources
(MDNR)revealed the existence of a plume of contamination in the underlying aquifer. The plume consisted primarily of hydrocarbons found in petroleum distillates, including benzene and toluene, and some solvents. Removal Actions Performed On June 10, 1982, members of the USCG District 9 air station met with Region V removal staff to discuss the possibilities and procedures for receiving CERCLA funds to pay for the connection of the homes within the Avenue E area of concern to the existing public water supply system while the USCG conducted a hydrogeologic investigation to further determine the source of contamination identified by MDNR and MDPH. According to the On Scene Coordinator's
(OSC)report, the USCG could not pay for such connections without knowing their extent of responsibility. The Coast Guard agreed to enter into a Memorandum of Understanding
(MOU)with USEPA assuring to reimburse the Agency for all costs incurred for the connections should the USCG be found to be the responsible party. USEPA then proceeded with the removal action and all home connections to the existing public water supply were completed on December 12, 1982. A total of 59 homes received city water with nine home owners declining to receive full hookups. A total of 67 homes received some level of service from this action. The total cost reimbursed by the USCG to USEPA was $137,540. Although not all residents received full hookups to the public water supply system, the plume associated with the Coast Guard property no longer exists and therefore would indicate that no risk currently exists to those not fully connected to the public water supply from the contamination associated with the Coast Guard property. Remedial Investigation and Feasibility Study (RI/FS) Groundwater The first investigation of the site was conducted by the MDNR in 1982. The State Agency's study objectives were to locate and delineate the contaminant plume, identify and determine the distribution of its component parts and locate the probable source area of the plume. The MDNR drilled 24 wells and two auger holes along Parsons Road and around the lots of Jacklyn Steel and Nish-Nah-Bee Industries. As a result of this investigation, the MDNR determined that the USCG Air Station property was part of the suspected source area. The USCG contracted with the United States Geological Service
(USGS)in July 1982 to undertake a study of the area's hydrogeologic conditions. Objectives of this study were:
(1)To determine the rate and direction of groundwater flow;
(2)locate the source or sources of contaminants;
(3)determine the extent and distribution of contaminants;
(4)evaluate hydrologically suitable locations for installing purge wells should that be necessary. The USCG installed a total of 138 wells on the Coast Guard property, up and down gradient of the base in and around the industrial areas and residential area. Five wells were installed to conduct a pump test for determining aquifer characteristics. At the request of the USCG, a team from the University of Michigan conducted a study of the site from February through August 1984. Building on the data and results given in the USCG report, the study was to be complementary to the USCG effort. By providing data and analysis on the time variation of contaminants, the effect of soil adsorptive characteristics on contaminant distribution and movement, and the potential risk posed by the contamination to public health, probable contaminant sources could be determined and remedial action alternatives developed. A total of 24 wells including 15 existing and nine new wells were selected for analysis based on previous information. These wells were sampled six times at 21-day intervals. Statistical analysis was performed on the data and various data plots were generated. This information was used to provide supporting information for developing response alternatives. A preliminary risk assessment was made for the various chemical components found in the plume. A contaminant transport computer model was used to help determine the possible origin of the plume and the effectiveness of various purge well combinations. Finally, several cleanup alternatives were identified and discussed. Following the 1982 removal action, the Coast Guard also contracted and supervised additional groundwater investigations complementing those conducted earlier by the MDNR to aid in the planning of a long term response. Results of these investigations concluded the following: • A plume of contamination was found stretching from near the Hanger/Administration
(HA)building on the Coast Guard Property to East Bay. It was approximately 4300 feet long and from 180 to 400 feet wide. Hydrocarbon spectra of the contamination were consistent with that of 115/145 aviation gasoline. Major components were benzene, toluene and xylene with a maximum concentration of 3640 μg/l, 553000 μg/l and 5410 μg/l, respectively. • An additional contaminant plume was discovered on the Coast Guard property with parent origin near the Coast Guard's fueling station. Around the fueling station several inches of pure JP-4 jet fuel product were found floating on the water table. • A third contaminant plume was found along the Coast Guard's south fence line up-gradient from the fuel farm area. Possible origins include a 1979 Republic Airlines jet fuel spill and various underground storage tanks in the area that had since been removed. • The contaminants were located in a sandy aquifer of high permeability. Groundwater flow is to the northeast with a velocity of approximately five feet per day. • A probable source of the original plume was a fuel spill in 1969 at the Coast Guard base in which about 2500 gallons of aviation gasoline leaked into the ground at a fuel station located under the northwest corner of the new HA building. The second plume may have originated from leaking JP4 fuel tanks at the current fuel station. To mitigate adverse effects discovered during the investigation, interim responses were implemented. In addition to providing city water connections to affected residents in the Avenue E area, the USCG also installed and operated interdiction and purge systems with treatment capability to prevent additional offsite contaminant migration and removed and/or repaired tanks at the Coast Guard fueling station. In addition to the investigation of groundwater, the USGS and the University of Michigan
(UM)reported numerous measurements of organics in the soils at the Coast Guard Air Station. The UM study found maximum concentrations of 25.4 μg/g benzene, 27.6 μg/g toluene, and 229 μg/g xylene. Analyses were made for seven other hydrocarbons with negative results. Soil borings indicate that much of the organic material was adsorbed on the soil in a 6” to 12” thick layer in the capillary zone immediately above the water table. The UM suggested that this zone was slowly leaking organic contaminants into the groundwater over time and was serving as a source for the plume. Record of Decision Findings There was no Record of Decision
(ROD)for this site. In 1987, an agreement between the State of Michigan and the USCG was negotiated. USCG agreed to pay the cost of implementing the cleanup of contamination emanating from the USCG air station. All clean up activities associated with the Ave E site were conducted as part of this Settlement agreement. Characterization of Remaining Risk The municipal water supply system serving the East Bay township residences and business currently meets federal and state drinking water standards and is safe for human consumption. The source of the township's municipal water system is groundwater wells located in East Bay Township and monitored every three years. The wells used to supply water to East Bay Township are quite a distance up-gradient of the Coast Guard Facility, and the monitoring frequency for these wells is adequate. Currently, soil vapor intrusion is not considered a possible problem at the Site. Down gradient monitoring wells placed along Avenue E in the residential area where the plume was traced, have found no detectable levels of contaminants of concern associated with the USCG plume. Response Actions In 1987, an agreement between the State of Michigan and the USCG was negotiated. USCG agreed to pay the cost of implementing the cleanup of contamination emanating from the site. The cleanup involved extraction and treatment of contaminated groundwater. Some of the other remedial actions included enhanced biodegradation using hydrogen peroxide and nitrates to reduce plume contaminates. The USCG also implemented groundwater sparging with vapor extraction, venting with vapor extraction, soil venting, natural attenuation and surfactant injection and extraction. All of these additional remedial measures helped to reduce the contaminant source in the soil and speed treatment of the groundwater through the pump and treatment system. The contaminated groundwater was treated by activated carbon prior to discharge to the Traverse City Sewer system. By 1996, the contaminant levels rarely exceeded the cleanup criteria stipulated in the 1987 settlement agreement. In 1999, the wells remained clean. A Preliminary Closeout Report
(PCOR)was completed by U.S. EPA in September 2000. The purpose of the PCOR was to document that all construction activity had been completed at the Site. Institutional Controls There were no provisions for institutional controls in any of the agreements associated with the clean up and monitoring of this site as the groundwater was to be remediated to unrestricted use. Cleanup Standards The cleanup standards in the 1987 Settlement Agreement were designed to meet the contaminant levels for benzene, tetrachloroethylene and trichloroethylene as required by the State of Michigan (MDNR), based on acceptable standards in place at the time the Settlement Agreement was issued. This was an agreement between the MDNR and USCG. If these standards were not met, then additional measures would be taken. This Site is being deleted because the remedial response met all cleanup standards outlined in the 1987 Settlement Agreement. Operation and Maintenance USCG has completed monitoring groundwater at the site in accordance with the Settlement Agreement between the State of Michigan and the USCG filed on June 1, 1987. Per the Settlement Agreement with the State of Michigan, the USCG operated two interdiction fields (pump and treatment systems). There was one at the North of the base and one at the South of the base. They consisted of wells IN2, IN3, IN4, IN5, and IN6 in the North field (avgas plume) and PP5, PP7, and PP8 in the South Field (JP-4 field). Each interdiction point had point of compliance wells along the USCG property boundary. The North field point of compliance wells were M56, M1, M4, M3, and M55. The South field point of compliance wells were M22, M61, M62, and M64. There were a number of other wells installed over the course of the project for various reasons. In 2000, with consent of MDEQ, the USCG removed wells PP5, PP6, PP7 and PP8. In 2001, with the consent of MDEQ, wells IN2, IN3, IN4, IN5 and IN6 were removed along with the associated piping, manifolds, carbon treatment units, and discharge lines for both the North and South interdiction fields. The remaining monitoring wells will be removed after the 10 year post closure period. The post closure period started in October 2005. Five-Year Review EPA conducted a five-year review of the Site in 2005. In the review, EPA concluded that all remedial actions are complete and monitoring indicates that all clean up goals have been reached in connection with the 1987 Settlement Agreement. Therefore, no future five-year review, are required for this Site. Community Involvement Public participation activities have been satisfied as required in CERCLA section 113(k), 42 U.S.C. 9613(k), and CERCLA section 117, 42 U.S.C. 9617. Documents in the deletion docket which EPA relied on for recommendation of the deletion of this Site from the NPL are available to the public in the information repositories, and in *http://www.regulations.gov.* V. Deletion Action The EPA, with concurrence of the State of Michigan, determined that all appropriate responses under CERCLA have been completed, and that no further response actions under CERCLA are necessary. Therefore, EPA is deleting the Site from the NPL. Because EPA considers this action to be non-controversial and routine, EPA is taking it without prior publication. This action will be effective March 20, 2007 unless EPA receives adverse comments by February 20, 2007. If adverse comments are received within the 30-day public comment period, EPA will publish a timely withdrawal of this direct final notice of deletion before the effective date of the deletion and it will not take effect. EPA will prepare a response to comments and, as appropriate, continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment. List of Subjects in 40 CFR Part 300 Environmental protection, Air pollution control, Chemicals, Hazardous waste, Hazardous substances, Intergovernmental relations, Penalties, Reporting and record keeping requirements, Superfund, Water pollution control, Water supply. Dated:January 9, 2007. Mary A. Gade, Regional Administrator, U.S. EPA Region V. For the reasons set out in this document, 40 CFR part 300 is amended as follows: PART 300—[AMENDED] 1. The authority citation for part 300 continues to read as follows: Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p.351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp., p.193. Appendix B—[Amended] 2. Table 1 of Appendix B to Part 300 is amended under “MI” by removing the entry for “Avenue E Groundwater Contamination” and the city “Traverse City.” [FR Doc. E7-694 Filed 1-18-07; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 RIN 0648-AT60 [Docket No.061020273-7001-03; I.D. 010307A] Fisheries of the Northeastern United States; Summer Flounder Fishery; Emergency Rule AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Temporary rule; emergency action; request for comments. SUMMARY: NMFS is implementing, through this emergency rule, revised summer flounder total allowable landings
(TAL)for the 2007 fishing year. This emergency rule specifies allowed harvest limits for both the commercial and recreational summer flounder fisheries. The TAL contained within this emergency rule supersedes the previous harvest limits for summer flounder that became effective on January 1, 2007. This action continues the prohibition on federally permitted commercial vessels landing summer flounder in Delaware in 2007 due to continued quota repayment of previous year's overages. This emergency rule is necessary to increase the 2007 summer flounder harvest levels consistent with the recently enacted Magnuson-Stevens Fishery Conservation and Management Reauthorization Act of 2006 (Reauthorized Magnuson-Stevens Act), while ensuring compliance with regulations implementing the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan (FMP). In addition, this action will continue to ensure that fishing mortality rates
(F)or exploitation rates, as specified in the FMP, are not exceeded. DATES: Effective from January 19, 2007 through July 18, 2007. Comments must be received at the appropriate address or fax number (see ADDRESSES ) by 5 p.m., local time, on February 20, 2007. ADDRESSES: Written comments should be submitted by any of the following methods: • *Mail:* Patricia A. Kurkul, Regional Administrator, NMFS, Northeast Regional Office, One Blackburn Drive, Gloucester, MA 01930. Mark the outside of the envelope, “Comments on Summer Flounder Emergency Action.” • *E-mail:* SummerFlounderEmergency@noaa.gov • *Fax:*
(978)281-9135 • *Electronically through the Federal e-Rulemaking portal: http//www.regulations.gov* . Copies of the Supplemental Environmental Assessment are available from Patricia A. Kurkul, Regional Administrator, Northeast Region, National Marine Fisheries Service, One Blackburn Drive, Gloucester, MA 01930-2298. This document is also accessible via the Internet at *http://www.nero.noaa.gov* . FOR FURTHER INFORMATION CONTACT: Michael P. Ruccio, Fishery Policy Analyst,
(978)281-9104. SUPPLEMENTARY INFORMATION: Summer flounder is currently under a rebuilding plan. NMFS published a final rule containing the 2007 summer flounder TAL on December 14, 2006 (71 FR 75134). The 12.983-million-lb (5,889-mt) TAL contained within that rule became effective on January 1, 2007. The TAL implemented by that rule was a 45-percent decrease from the TAL specified for 2006. The 12.983-million-lb (5,889-mt) TAL was developed utilizing the best available scientific information. The regulations at 50 CFR 648.100 require that NMFS implement measures (e.g., a TAL) necessary to ensure, with at least a 50-percent probability, that F max (i.e., level of fishing that produces maximum yield per recruit) will not be exceeded. The 12.983-million-lb (5,889-mt) TAL has greater than a 99-percent probability of not exceeding F max , the level at which overfishing is considered to be occurring. It also has an associated F level that will provide stock rebuilding within the 10-year statutory period under section 304 of the Magnuson-Stevens Act prior to its December 2006 reauthorization. The F level calculated to rebuild the stock within the 10-year period is F rebuild =0.15; the 12.983-million-lb (5,889-mt) TAL has a 75-percent probability of achieving this F rebuild . Since the publication of the 2007 summer flounder TAL in the **Federal Register** , the Reauthorized Magnuson-Stevens Act was signed into law on January 12, 2007. Contained within the Reauthorized Magnuson-Stevens Act is a specific provision under section 120(a) that provides the Secretary the authority to extend the rebuilding time frame ending date for summer flounder to no later than January 1, 2013, provided that several specific conditions are met. The Secretary must determine that: 1. Overfishing is not occurring in the summer flounder fishery and that a mechanism is in place to ensure overfishing does not occur in the fishery and stock biomass levels are increasing; 2. The biomass rebuilding target previously applicable to the summer flounder stock will be met or exceeded within the new time for rebuilding; 3. The extension period is based on the status and biology of the stock and the rate of rebuilding; 4. Monitoring will ensure rebuilding continues; 5. The extension meets the requirements of National Standard 1 found at section 301(a)(1) of the Magnuson-Stevens Act; and 6. The best scientific information available shows that the extension will allow continued rebuilding. The Secretary has determined that these six criteria have been met and that there is a reasonable basis to extend the summer flounder rebuilding time frame to no later than January 1, 2013. A detailed discussion of the Secretarial determinations occurs later in this preamble, under *Secretarial Determinations Required by Section 120(a) of the Reauthorized Magnuson-Stevens Act* . Based on these determinations, the Secretary is implementing, through this emergency rule, a 17.112-million-lb (7,762-mt) TAL, based on the revised rebuilding time frame ending no later than January 1, 2013, which supersedes the previous TAL of 12.983 million lb (5,889 mt), which was based on a rebuilding period end date of January 1, 2010. The 17.112-million-lb (7,762-mt) TAL will be allocated 10.27 million lb (4,658 mt) to the commercial sector and 6.84 million lb (3,104 mt) to the recreational sector. This emergency rule does not alter the previous amount of summer flounder set aside for research in the December 14, 2006, final rule. The research set-aside
(RSA)level is not being increased by this emergency rule in order to ensure that the issuance of grants and exempted fishing permits required to conduct the research projects occurs in a timely fashion. Four research projects that would utilize the previously established summer flounder RSA of 389,490 lb (177 mt) have been conditionally approved by NMFS and are currently awaiting notice of award. If a project is not approved by the NOAA Grants Office, the research quota associated with the disapproved proposal will be restored to the summer flounder TAL through publication of a notice in the **Federal Register** . Consistent with the revised quota setting procedures for the FMP at § 648.100(a)(1)(ii), summer flounder overages are determined based upon landings for the 2005 calendar year that were not accounted for in the 2006 final rule (70 FR 77060, December 29, 2005), and any 2006 fishing year overages through October 31, 2006. Table 1 summarizes for each state, based on the TAL implemented though this emergency rule, the commercial summer flounder percent share, the 2007 commercial quota (both initial and less the RSA), the quota reductions from overages as previously described, the resulting adjusted 2007 commercial quota, and the increase in quota from the December 14, 2006, final rule resulting from this emergency rule. Recreational harvest limits, based on the TAL implemented by this emergency rule, will be the subject of a separate rulemaking within the first quarter of 2007. COMMERCIAL SUMMER FLOUNDER ALLOCATIONS FOR 2007 State Percent Share Initial Quota lb kg Initial Quota, Less RSA lb kg Quota Overages (through 10/31/06) 1 lb kg Adjusted Quota less RSA 2 lb kg Change in Quota from Dec.14, 2006, Final Rule to Emergency Action lb kg ME 0.04756 4,883 2,215 4,772 2,165 0 0 4,772 2,165 1,178 534 NH 0.00046 47 21 46 21 0 0 46 21 11 5 MA 6.82046 700,270 317,643 684,331 310,413 30,046 13,629 654,285 296,784 168,970 76,645 RI 15.68298 1,610,203 730,388 1,573,553 713,764 0 0 1,573,553 713,764 388,530 176,237 CT 2.25708 231,739 105,117 226,464 102,724 16,470 7,471 209,994 95,253 55,917 25,364 NY 7.64599 785,029 356,089 767,161 347,984 148,038 67,150 619,123 280,834 197,346 89,516 NJ 16.72499 1,717,188 778,917 1,678,103 761,187 0 0 1,678,103 761,187 414,345 187,947 DE 0.01779 1,827 829 1,785 810 50,528 22,920 -48,743 -22,110 441 200 MD 2.03910 209,358 94,965 204,593 92,803 0 0 204,593 92,803 50,516 22,914 VA 21.31676 2,188,634 992,765 2,138,818 970,168 0 0 2,138,818 970,168 528,101 239,547 NC 27.44584 2,817,919 1,278,208 2,753,780 1,249,115 0 0 2,753,780 1,249,115 679,943 308,422 Total 3 100.00 10,267,098 4,657,156 10,033,407 4,551,153 245,082 111,169 9,788,325 4,439,984 2,485,299 1,127,331 1 2006 quota overage is determined through comparison of landings for January through October 2006 plus any landings in 2005 in excess of the 2005 quota that were not previously addressed in the 2006 quota specifications, with the final 2006 quota for each state as published in the December 29, 2006 final rule (70 FR 77060). 2 Negative numbers indicate a state allocation in quota repayment status from previous year's overages. 3 Total quota is the sum of all states having allocation. A state with a negative number has an allocation of zero (0). Kilograms are as converted from pounds and may not necessarily add due to rounding. The Atlantic States Marine Fisheries Commission (Commission) has established a system whereby 15 percent of each state's quota may be voluntarily set aside each year to enable vessels to land an incidental catch allowance after the directed fishery in a state has been closed. The intent of the incidental catch set-aside is to reduce discards by allowing fishermen to land summer flounder caught incidentally in other fisheries during the year, while ensuring that the state's overall quota is not exceeded. These Commission set-asides are not included in these 2007 final summer flounder specifications because NMFS does not have authority to establish such subcategories. Delaware Summer Flounder Closure Table 1 indicates that, for Delaware, the amount of the 2006 summer flounder quota overage (inclusive of overharvest from previous years) is greater than the amount of commercial quota allocated to Delaware for 2007 under this emergency action. As a result, there is no quota available for 2007 in Delaware. The regulations at § 648.4(b) provide that Federal permit holders, as a condition of their permit, may not land summer flounder in any state that the Regional Administrator has determined no longer has commercial quota available for harvest. Therefore, landings of summer flounder in Delaware by vessels holding commercial Federal summer flounder fisheries permits are prohibited for the duration of this emergency rule, unless additional quota becomes available through a quota transfer and is announced in the **Federal Register** . Federally permitted dealers are advised that they may not purchase summer flounder from federally permitted vessels that land in Delaware for the duration of this emergency rule, unless additional quota becomes available through a transfer. Secretarial Determinations Required by Section 120(a) of the Reauthorized Magnuson-Stevens Act *Overfishing is not occurring and a mechanism is in place to ensure that overfishing does not occur.* The Secretary has determined that, as of January 1, 2007, overfishing was not occurring in the summer flounder fishery. The TAL of 12.983 million lb (5,889 mt) was effective January 1, 2007, and has greater than a 99-percent probability of not exceeding the overfishing threshold of F (F max = 0.28). The 17.112-million-lb (7,762-mt) TAL implemented by this emergency rule has a 75-percent probability of achieving the new F level (F rebuild =0.203) calculated for stock rebuilding by January 1, 2013. The 17.112-million-lb (7,762-mt) TAL has a 99-percent probability of not exceeding the 2007 F max threshold (0.28). The 17.112-million-lb (7,762-mt) TAL and associated commercial and recreational management measures will effectively ensure that overfishing does not occur in the summer flounder fishery in 2007. *Stock biomass levels are increasing.* Based on information in the peer reviewed “Summer Flounder Assessment and Biological Reference Point Update for 2006,” the best available scientific information for the summer flounder stock, the stock biomass level has continued to increase during the first 7 years of the rebuilding period. The updated 2006 assessment indicates that stock biomass levels are increasing, though stock growth has slowed. Spawning stock biomass (SSB; age 0+ fish) declined 69 percent from 1983 to 1989 (22,582 mt to 7,025 mt) but, with improved recruitment and decreased fishing mortality, had increased to 47,498 mt by 2005. Recruitment since 1988 has been estimated to have generally improved, although the 2003 and 2005 year classes were estimated to have been well below the median (33 million fish) at 24.5 million fish and 14.5 million fish, respectively. *The biomass target previously applied will be met or exceeded within the new rebuilding time frame.* Analysis conducted by the Northeast Fisheries Science Center (Center) indicates that fishing at a 17.112-million-lb (7,762-mt) TAL in 2007 will have a 75-percent probability of attaining the F target (F rebuild ) necessary to ensure that the rebuilding target (B msy proxy) of 197 million lb (89,359 mt) SSB is attained by January 1, 2013. *The rebuilding extension period is based on the status and biology of the stock and rate of rebuilding.* The information on the status and biology of the stock has been used, through the annual assessment, to derive an appropriate F target and subsequent quota for 2007 that is sufficient to ensure rebuilding occurs by January 1, 2013. Center analysis indicates that attaining the F rebuild target in 2007 will ensure that the stock rebuilding rate will remain on target to rebuild by January 1, 2013. *Monitoring will ensure that rebuilding continues.* The summer flounder stock is assessed annually by the Southern Demersal Working Group, using the latest research survey and fisheries catch data. During this assessment, the working group will assess the status of the stock and recommend to the Council an appropriate F target and TAL to satisfy the requirements of the FMP and the Reauthorized Magnuson-Stevens Act rebuilding requirements. Annual adjustments may be made by the Council and/or the Secretary to the 2008-2012 TALs to ensure that rebuilding continues within the specified time frame. *The extension meets the requirement of section 301(a)(1) (National Standard 1) of the Reauthorized Magnuson-Stevens Act.* The Secretary has determined that setting an appropriate TAL with a sufficient probability of attaining the F needed to ensure rebuilding of the summer flounder stock by January 1, 2013, is consistent with National Standard 1. Such measures will prevent overfishing and provide the optimum yield while so doing. *The best scientific information available shows that the extension will allow continued rebuilding.* The methodology employed in the Center's projections and derivation of the subsequent 17.112-million-lb (7,762-mt) TAL was recommended by the NMFS Office of Science and Technology Peer Review Panel and, as such, constitutes the best available scientific information. These methods had been used to derive the 12.983-million-lb (5,889-mt) TAL in place under the former rebuilding time frame of 10 years. These methods project the summer flounder stock will be rebuilt to the B msy proxy SSB level of 197 million lb (89,359 mt) by January 1, 2013, by employing a constant F strategy at the F rebuild =0.203 level in 2007 and in subsequent years of the rebuilding period. Classification The Assistant Administrator for Fisheries NOAA,
(AA)finds good cause pursuant to 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment because it would be impracticable and contrary to the public interest. This emergency action responds to a recently enacted reauthorization and amendment of the Magnuson-Stevens Fishery Act. Section 120 of the Reauthorized Magnuson-Stevens Act extends the rebuilding period for the summer flounder fishery from January 1, 2010, until no later than January 1, 2013. This extension allows for the setting of a higher TAL than was previously set to rebuild the fishery by the earlier rebuilding deadline. Consequently, this emergency action supersedes the 2007 annual TAL specification for summer flounder published on December 14, 2006, with a higher TAL. The measure contained within this emergency rule meets the fishing mortality objectives of the FMP and satisfies section 120(a) of the Reauthorized Magnuson-Stevens Act. Until this rule is effective, states and commercial fishermen are held to the quotas published on December 14, 2006. As a result of the Reauthorized Magnuson-Stevens Act, the quotas published on December 14, 2006, are rendered unnecessarily restrictive and are substantially less than the quotas available under the increased TAL. If effectiveness of the rule is delayed, state quotas and subsequent management measures designed to attain the quotas derived from the lower TAL would be inconsistent with the increased TAL available from the revised rebuilding period. Waiver of the notice-and-comment rulemaking period will serve the public by allowing states to implement commercial quotas and management measures afforded under the increased TAL in a timely fashion for the 2007 fisheries that began on January 1, 2007. States in the southern reaches of the Northeast Region have very active commercial fisheries that begin in January of each year while more northern states have need of establishing their annual management measures early within the new year so that fishery participants may plan first quarter fishing activities. The time required by NMFS to conduct notice-and-comment rulemaking for this emergency rule would require states to establish management measures for up to several months based on the lower TAL in place as of January 1, 2007. State management measures would likely require more restrictive possession and trip limits that increase the potential for discards and the likelihood that TALs may be attained and fisheries to be closed before additional quota is made available by this emergency rule. In addition, state agencies are currently developing and preparing conservation equivalency proposals for the 2007 recreational fishery to be submitted to the Atlantic States Marine Fisheries Commission during their January 29, 2007, meeting. Recreational fisheries do not begin in earnest until spring and NMFS anticipates publishing a final rule for 2007 recreational measures in March 2007. A delay of this emergency rule by notice-and-comment rulemaking would require states to craft conservation equivalency measures that meet the objectives of the lower TAL. Such measures would be inconsistent with the objectives of the increased TAL and would be unnecessarily more restrictive, requiring further revision after this rule becomes effective. Additional rulemaking would be required to implement less restrictive measures that meet the objectives of the higher TAL. NMFS did not initiate the emergency action earlier because provision of the Reauthorized Magnuson-Stevens Act that allows an extension of the summer founder rebuilding period and the subsequent increase in 2007 TAL was not signed into law by the President until January 12, 2007. The revised TAL is within the range of quota alternatives considered and analyzed by the Council, and discussed in the proposed rule that published on October 27, 2006, with a 21-day comment period. NMFS intends to provide a 30-day post-promulgation comment period following the implementation of this emergency rule. Waiver of this delay will allow state promulgated commercial management measures to be applied within days of the start of the 2007 fishing season and for recreational management measures to be proposed to meet the objectives contained within the higher TAL. These state measures will be consistent with the publicly and Congressionally expected increase in TAL resulting from the extended rebuilding time frame authorized in section 120(a) of the Reauthorized Magnuson-Stevens Act. For the same reasons, the Assistant Administrator for Fisheries, NOAA, finds good cause pursuant to 5 U.S.C 553(d)(3) to make this rule effective immediately, thereby waiving the 30-day delayed effective date required by 5 U.S.C. 553(d). This final rule has been determined to be not significant for purposes of Executive Order 12866. This rule is exempt from the procedures of the Regulatory Flexibility Act because the rule is not subject to the requirement to provide prior notice and opportunity for public comment pursuant to 5 USC 553 or any other law. Dated: January 17, 2007. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service. [FR Doc. 07-231 Filed 1-17-07; 1:10 pm]
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  • 2 CFR 1532
  • 48 CFR 1509
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  • 40 CFR 30
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  • 40 CFR 35
  • 40 CFR 36
  • 40 CFR 46
  • 40 CFR 80
  • Pub. L. 103-355
  • 108 Stat. 3327
  • 2 CFR 180
  • 3 CFR 1986
  • 3 CFR 1989
  • 48 CFR 9
  • EO 11738
  • 7 USC 163w(a)(1)
  • Pub. L. 109-54
  • 42 USC 300v-1(b)
  • 7 USC 135
  • 41 USC 701
  • 63 Stat. 390
  • 40 USC 486(c)
  • 18 CFR 358
  • 468 F.3d 831
  • 822 F.2d 1123
  • 773 F.2d 327
  • 969 F.2d 1187
  • 18 CFR 385.5(c)(4)
  • 18 CFR 161
  • 18 CFR 37.4
  • 18 CFR 161.2(c)
  • 18 CFR 161.1
  • 5 CFR 1320.11
  • 5 USC 601-612
  • 15 USC 717-717w
  • 16 USC 791-825r
  • 42 USC 7101-7352
  • 19 CFR 123
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F. App'x468 F.3d 831
F. App'x822 F.2d 1123
F. App'x773 F.2d 327
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