Unknown. Final rule
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/register/2008/04/23/08-1173A 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-2008-04-23.xml --- 73 79 Wednesday, April 23, 2008 Contents Agency Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 21954-21956 E8-8445 National Advisory Council for Healthcare Research and Quality: Request for Nominations for Public Members, 21956-21957 E8-8614 Agriculture Agriculture Department See Food and Nutrition Service See Forest Service Antitrust Antitrust Division NOTICES The National Cooperative Research and Production Act of 1993:
Advanced Media Workflow, 21984-21985 E8-8628 DVD Copy Control Association, 21984 E8-8629 Open Devicenet Vendor Association, Inc., 21984 E8-8622 Arts Arts and Humanities, National Foundation See National Foundation on the Arts and the Humanities Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 21957-21959 E8-8624 E8-8625 E8-8626 E8-8648 Coast Guard Coast Guard RULES Special Local Regulation: Opening Day on San Francisco Bay Bay, Pacific Inter-Club Yacht Association, San Francisco, CA, 21824 E8-8736 Special Local Regulation;
Blessing of the Fleet, Corinthian Yacht Club, San Francisco Bay, CA, 21824-21825 E8-8733 PROPOSED RULES Safety Zone; Festival of Sail 2008 Ship's Parade: San Diego Harbor, San Diego, California, 21880-21882 E8-8732 Security Zone; Patapsco River, Middle Branch, Baltimore, MD, 21883-21885 E8-8728 Commerce Commerce Department See Foreign-Trade Zones Board See Industry and Security Bureau See International Trade Administration See National Oceanic and Atmospheric Administration NOTICES Availability of Fleet Alternative Fuel Vehicle Report for Fiscal Year 2007, 21902-21903 E8-8855 Commodity Commodity Futures Trading Commission NOTICES Proposal to Exempt the Trading and Clearing of Certain Products Related to streetTRACKS Gold Trust Shares, 21917-21919 E8-8942 Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 22004-22006 E8-8739 E8-8740 Defense Defense Acquisition Regulations System RULES Defense Federal Acquisition Regulation Supplement; Earned Value Management Systems, 21844-21850 E8-8694 E8-8695 E8-8698 E8-8706 PROPOSED RULES Defense Federal Acquisition Regulation Supplement; Quality Assurance Authorization of Shipment of Supplies, 21891-21893 E8-8696 E8-8697 Defense Defense Department See Defense Acquisition Regulations System NOTICES Meetings:
Defense Intelligence Agency National Defense Intelligence College Board of Visitors, 21919 E8-8801 Defense Science Board, 21919-21920 E8-8806 Secretary of Defense's Defense Advisory Board for Employer Support of the Guard and Reserve, 21920 E8-8803 Threat Reduction Advisory Committee, 21920-21921 E8-8804 TRICARE Voluntary Agreements for Retail Refunds Program, 21921 E8-8802 Record of Decision to Develop, Test, Deploy, and Plan for Decommissioning of the Ballistic Missile Defense System, 21921-21924 E8-8800 Education Education Department PROPOSED RULES Title I—Improving the Academic Achievement of the Disadvantaged, 22020-22044 E8-8700 Employee Employee Benefits Security Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 21987-21988 E8-8701 Employment Employment and Training Administration NOTICES Affirmative Determination for Reconsideration; Household Utilities, Inc., Kiel, WI, 21988 E8-8781 Certification Eligibility Investigation: Petitions for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance, 21988-21989 E8-8774 Eligibility Certification for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance: American Axle & Manufacturing, Buffalo Gear and Axle Facility, Buffalo, NY, 21989-21990 E8-8776 OEM/Erie, Inc., Erie, PA, 21990 E8-8779 Eligibility Determinations for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance, 21990-21992 E8-8775 Negative Determination for Reconsideration;
Dynamerica Manufacturing, LLC, Muncie, IN, 21992 E8-8780 Revised Determination on Reconsideration: Longview Fibre Paper and Packaging, Inc., Longview, WA, 21992-21993 E8-8778 Precision Magnetics, Wayne, NJ, 21993 E8-8777 Termination of Investigation: Mavrick Metal Stamping Inc., Mancelona, MI, 21993-21994 E8-8782 MPC Computers, LLC, La Vergne, TN, 21994 E8-8773 Energy Energy Department See Federal Energy Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 21924 E8-8768 Meetings:
Electricity Advisory Committee, 21924-21925 E8-8769 Environmental Management Site-Specific Advisory Board, Northern New Mexico, 21925-21926 E8-8770 EPA Environmental Protection Agency RULES Cyazofamid; Pesticide Tolerances, 21834-21839 E8-8371 Final Authorization of State Hazardous Waste Management Program Revisions; Utah, 21843 E8-8799 National Emission Standards for Hazardous Air Pollutants: Organic Liquids Distribution (Non-Gasoline), 21825-21834 E8-8810 Pyraclostrobin; Pesticide Tolerance for Emergency Exemptions, 21839-21843 E8-8675 PROPOSED RULES National Emission Standards for Hazardous Air Pollutants:
Organic Liquids Distribution (Non-Gasoline), 21889-21891 E8-8811 Revisions to the California State Implementation Plan: Pesticide Element; Ventura County, 21885-21889 E8-8812 NOTICES Adequacy Status: Indiana and Ohio Portions of Cincinnati-Hamilton; Sumitted 8-hour Ozone Attainment Demonstration, etc., 21932 E8-8858 Certain New Chemicals; Receipt and Status Information, 21932-21941 E8-8794 E8-8796 Draft Toxicological Review of 2-Hexanone: In Support of the Summary Information in the Integrated Risk Information System, 21941-21942 E8-8797 Fenamiphos;
Receipt of Request to Voluntarily Cancel Certain Pesticide Registrations, 21942-21944 E8-8568 Formaldehyde/Paraformaldehyde Risk Assessments: Availability and Risk Reduction Options, 21944-21946 E8-8684 HHT Risk Assessments; Notice of Availability and Risk Reduction Options, 21946-21948 E8-8730 Triforine Reregistration Eligibility Decision; Availability, 21948-21949 E8-8567 Executive Executive Office of the President See Presidential Documents FAA Federal Aviation Administration RULES Airworthiness Directives:
Boeing Model 757 Airplanes and Model 767 200, 767 300, and 767 300F Series Airplanes, 21811-21813 E8-8653 Establishment of Class E Airspace; Winona, MS, 21813-21814 E8-8578 PROPOSED RULES Airworthiness Directives: APEX Aircraft Model CAP 10 B Airplanes, 21851-21852 E8-8752 Bell Helicopter Textron Canada Model 222, 222B, 222U, 230, and 430 Helicopters, 21853-21854 E8-8754 Bell Helicopter Textron Canada Model 230 Helicopters, 21855-21857 E8-8755 Amendment of Class E Airspace; Salyer Farms, CA, 21857-21858 E8-8727 Proposed Establishment of Class E Airspace;
Carson City, NV, 21858-21859 E8-8725 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 21998-22000 E8-8726 E8-8729 E8-8731 E8-8737 Change in Use of Aeronautical Property at Barnes Municipal Airport, Westfield, Massachusetts, 22000 E8-8738 FCC Federal Communications Commission RULES Telecommunications Relay Services and Speech-to-Speech Services for Individuals with Hearing and Speech Disabilities: Request for Stay Pending Judicial Review, 21843-21844 E8-8793 FDIC Federal Deposit Insurance Corporation NOTICES Interim Final Statement of Covered Bond Policy, 21949-21953 E8-8750 Federal Emergency Federal Emergency Management Agency NOTICES Meetings:
National Advisory Council, 21970 E8-8828 Federal Energy Federal Energy Regulatory Commission RULES Statement of Administrative Policy on Processing Reliability Notices of Penalty and Revisions to Order No. 672, 21814-21818 E8-8745 PROPOSED RULES Mandatory Reliability Standard for Nuclear Plant Interface Coordination, 21859-21860 E8-8615 NOTICES Combined Notice of Filings, 21926-21931 E8-8746 E8-8747 E8-8748 E8-8785 Federal Highway Federal Highway Administration NOTICES Environmental Impact Statement:
City of Bakersfield, Kern County, California, 22000-22001 E8-8795 Environmental Statements; Availability, etc.: Cameron County, TX, 22001 E8-8783 I-70 Kansas City to St. Louis, MO, 22002 E8-8761 FMC Federal Maritime Commission NOTICES Ocean Transportation Intermediary License Applicants, 21953 E8-8807 Ocean Transportation Intermediary License Reissuances, 21953-21954 E8-8808 Federal Reserve Federal Reserve System NOTICES Meetings; Sunshine Act, 21954 08-1175 Fish Fish and Wildlife Service NOTICES Availability for the Draft Monument Management Plan and Environmental Assessment, etc.:
Papahanaumokuakea Marine National Monument, HI, 21975-21977 E8-8362 Issuance of Permits, 21977-21978 E8-8786 Lake Woodruff National Wildlife Refuge, Volusia and Lake Counties, FL, 21978-21979 E8-8760 Receipt of Applications for Permit, 21979-21982 E8-8765 E8-8766 E8-8787 Food Food and Drug Administration RULES New Animal Drugs; Enrofloxacin, 21819 E8-8713 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 21959-21962 E8-8710 Public Workshop:
Developing Guidance on Pharmacoepidemiologic Safety Studies— Conducting Scientifically Sound Safety Studies Using Large Electronic Healthcare Data Sets, 21963-21964 E8-8772 Food Food and Nutrition Service RULES Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Miscellaneous Vendor-Related Provisions, 21807-21811 E8-8767 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 21900-21902 E8-8792 E8-8835 MISSING FOR: Foreign-Trade Zones Board Foreign-Trade Zones Board NOTICES Trade Zone 161 Sedgwick County, Kansas:
Application for Subzone Status Hawker Beechcraft Corporation, 21903-21904 E8-8814 Forest Forest Service NOTICES Meetings: Lake Tahoe Basin Federal Advisory Committee, 21902 E8-8627 Termination of Withdrawal; Alaska, 21902 E8-8704 Health Health and Human Services Department See Agency for Healthcare Research and Quality See Children and Families Administration See Food and Drug Administration See Indian Health Service See National Institutes of Health NOTICES Meetings: Advisory Committee on Minority Health, 21954 E8-8705 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency See U.S.
Customs and Border Protection Housing Housing and Urban Development Department NOTICES Federal Property Suitable as Facilities to Assist the Homeless, 21971-21972 E8-8068 HOPE VI Program, 21972 E8-8833 Mortgagors Certificate of Actual Cost, 21972-21973 E8-8830 Privacy Act; Proposed New System of Records, 21973-21975 E8-8844 Indian Indian Affairs Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 21982-21983 E8-8763 Indian Indian Health Service NOTICES Tribal Management Grant Program;
Correction, 22017 Z8-6429 Industry Industry and Security Bureau NOTICES Meetings: Transportation and Related Equipment Technical Advisory Committee, 21904 E8-8741 Interior Interior Department See Fish and Wildlife Service See Indian Affairs Bureau See Land Management Bureau See Surface Mining Reclamation and Enforcement Office IRS Internal Revenue Service PROPOSED RULES Measurement of Assets and Liabilities for Pension Funding Purposes; Hearing, 21860 E8-8816 Nuclear Decommissioning Funds;
Hearing, 21860-21861 E8-8815 Section 1221(a)(4) Capital Asset Exclusion for Accounts and Notes Receivable, 21861 E8-8817 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22006-22016 E8-8818 E8-8819 E8-8820 E8-8854 E8-8856 E8-8857 International International Investment Office PROPOSED RULES Mergers, Acquisitions, and Takeovers by Foreign Persons, 21861-21880 08-1172 International International Trade Administration NOTICES Certain Preserved Mushrooms from the Peoples Republic of China:
Final Results of Antidumping Duty New Shipper Review, 21904-21906 E8-8809 Meetings: Manufacturing Council, 21906 E8-8877 Preliminary Determination of Sales at Less Than Fair Value: Sodium Nitrite from the Federal Republic of Germany, 21909-21912 E8-8836 Sodium Nitrite from the People's Republic of China, 21906-21909 E8-8832 Justice Justice Department See Antitrust Division NOTICES Lodging Proposed Consent Decree, 21983-21984 E8-8647 Labor Labor Department See Employee Benefits Security Administration See Employment and Training Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 21985 E8-8703 Meetings: Public Hearing to Collect Information to Assist in the Development of the List of Goods From Countries Produced by Child Labor or Forced Labor, 21985-21987 E8-8709 Land Land Management Bureau NOTICES Coal Lease Exploration License; WY, 21983 E8-8751 National Foundation National Foundation on the Arts and the Humanities NOTICES Meetings: Arts Advisory Panel, 21994 E8-8550 NIH National Institutes of Health NOTICES Meetings:
Interagency Autism Coordinating Committee, 21964 E8-8724 National Cancer Institute, 21964-21965 E8-8609 National Cancer Institute Clinical Trials Advisory Committee, 21965 E8-8721 National Center for Complementary and Alternative Medicine Special Emphasis Panel, 21965 E8-8712 National Eye Institute, 21965-21966 E8-8605 National Heart, Lung, and Blood Institute Special Emphasis Panel; Women's Health Initiative, 21966 E8-8722 National Human Genome Research Institute, 21966 E8-8611 National Institute of Child Health and Human Development, 21967, 21969 E8-8610 E8-8717 Specific Learning Disabilities National Institute of General Medical Sciences, 21966-21967 E8-8608 National Institute of Mental Health, 21967-21968 E8-8612 National Institute on Aging, 21968 E8-8613 National Institute on Drug Abuse Special Emphasis Panel;
The Interaction of HIV, Drug Abuse and Criminal Justice, 21968-21969 E8-8715 E8-8716 E8-8719 mtgs: National Institute of General Medical Sciences Special Emphasis Panel; NIH Support for Conferences and Scientific Meetings, 21969-21970 E8-8720 NOAA National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska: Pacific Ocean Perch in the Bering Sea and Aleutian Islands Managment Area, 21850 08-1173 PROPOSED RULES Magnuson-Stevens Act Provisions;
Limited Access Privilege Programs: Individual Fishing Quota; Referenda Guidelines and Procedures for the New England Fishery Management Council, et al., 21893-21899 E8-8756 NOTICES Availability for the Draft Monument Management Plan and Environmental Assessment, etc.: Papahanaumokuakea Marine National Monument, HI, 21975-21977 E8-8362 Climate Change Science Program Synthesis and Assessment Product Draft Report 5.2: “Best Practice Approaches for Characterizing, Communicating, and Incorporating Scientific Uncertainty in Decisionmaking”, 21912-21913 E8-8829 Endangered and Threatened Species;
Recovery Plans, 21913-21917 E8-8831 Revised Draft Framework: Developing the National System of Marine Protected Areas and Response to Comments, 21917 E8-8672 Nuclear Nuclear Regulatory Commission NOTICES Meetings: Advisory Committee on Reactor Safeguards, 21994-21995 E8-8764 Progress Energy: Acceptance for Docketing of an Application for Combined License for Shearon Harris Units 2 and 3, 21995-21996 E8-8762 Presidential Presidential Documents EXECUTIVE ORDERS Amendments to Executive Orders 13389 and 13390 (EO 13463), 22045-22047 08-1182 SEC Securities and Exchange Commission RULES Proposed Rule Changes of Self-Regulatory Organizations;
Correction, 22017 Z8-8267 NOTICES Self-Regulatory Organizations: International Securities Exchange, LLC; Limitation of Liability, 21996 E8-8735 Self-Regulatory Organizations; Proposed Rule Changes: Chicago Board Options Exchange, Incorporated Taker Fees, 21996-21997 E8-8784 SBA Small Business Administration NOTICES Disaster Declaration: Mississippi, 21998 E8-8759 Surface Surface Mining Reclamation and Enforcement Office RULES Virginia Regulatory Program, 21819-21823 E8-8838 Surface Surface Transportation Board NOTICES Consummation of Rail Line Abandonments Subject to Historic Preservation and Other Environmental Conditions, 22002-22004 E8-8771 Transportation Transportation Department See Federal Aviation Administration See Federal Highway Administration See Surface Transportation Board Treasury Treasury Department See Comptroller of the Currency See Internal Revenue Service See International Investment Office Customs U.S.
Customs and Border Protection NOTICES Country of Origin Marking for the Republic of Kosovo, 21970-21971 E8-8753 Meetings: The Departmental Advisory Committee on Commercial Operations of Customs and Border Protection and Related Homeland Security Functions (COAC), 21971 E8-8758 Separate Parts In This Issue Part II Education Department, 22020-22044 E8-8700 Part III Executive Office of the President, Presidential Documents, 22045-22047 08-1182 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 73 79 Wednesday, April 23, 2008 Rules and Regulations DEPARTMENT OF AGRICULTURE Food and Nutrition Service 7 CFR Part 246 [FNS-2007-0041] RIN 0584-AD36 Special Supplemental Nutrition Program for Women, Infants and Children (WIC):
Miscellaneous Vendor-Related Provisions AGENCY: Food and Nutrition Service (FNS), USDA. ACTION: Final rule. SUMMARY: This final rule amends the regulations governing the WIC Program to clarify issues that have arisen subsequent to the publication of the WIC Food Delivery Systems Final Rule on December 29, 2000, and to strengthen further the requirements for State vendor management and infant formula cost-containment systems. This rule contains provisions that would prohibit a State agency from requiring an infant formula manufacturer to provide free infant formula or other items in its infant formula rebate bid solicitation and contract; require that a State agency provide an abbreviated administrative review when a vendor receives a WIC civil money penalty
(CMP)as a result of a Food Stamp Program
(FSP)disqualification; and expand the types of vendor information that a State agency may release for general program purposes. Technical changes were also made to 7 CFR 246.16a due to revisions made to the WIC Food Packages, published in the **Federal Register** December 6, 2007. This rule updates regulatory citations contained in 7 CFR 246.16a that refer to 7 CFR 246.10. DATES: *Effective Date:* This rule is effective June 23, 2008. *Implementation Date:* State agencies must implement the provisions of this rule no later than October 23, 2008. FOR FURTHER INFORMATION CONTACT: Debra R. Whitford, Chief, Policy and Program Development Branch, Supplemental Food Programs Division, Food and Nutrition Service, 3101 Park Center Drive, Room 522, Alexandria, Virginia 22302,
(703)305-2746. SUPPLEMENTARY INFORMATION: Executive Order 12866 This rule has been determined to be non-significant and was not reviewed by the Office of Management and Budget in conformance with Executive Order 12866. Regulatory Flexibility Act This rule has been reviewed with regard to the requirements of the Regulatory Flexibility Act of 1980 (5 U.S.C. 601-612). The Administrator, Food and Nutrition Service, has certified that this rule will not have a significant impact on a substantial number of small entities. This rule modifies language used in WIC infant formula rebate solicitations and contracts, as well as in vendor agreements. The effect of these changes would fall primarily on State agencies. Vendors authorized by the WIC Program to provide supplemental foods, some of which are small entities, could also be affected. However, the impact on small entities is expected to be minimal. Unfunded Mandates Reform Act Title II of the 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under Section 202 of the UMRA, the Department generally must prepare a written statement, including a cost/benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, or tribal governments in the aggregate, or to the private sector, of $100 million or more in any one year. When such a statement is needed for a rule, section 205 of the UMRA generally requires the Department to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, more cost-effective or least burdensome alternative that achieves the objectives of the rule. This rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) that impose costs on State, local, or tribal governments or to the private sector of $100 million or more in any one year. This rule is, therefore, not subject to the requirements of sections 202 and 205 of the UMRA. Executive Order 12372 The Special Supplemental Nutrition Program for Women, Infants and Children
(WIC)is listed in the Catalog of Federal Domestic Assistance Programs under No. 10.557. For reasons set forth in the final rule in 7 CFR Part 3015, Subpart V, and related Notice (48 FR 29114), this program is included in the scope of Executive Order 12372 that requires intergovernmental consultation with State and local officials. Federalism Summary Impact Statement Executive Order 13132 requires Federal agencies to consider the impact of their regulatory actions on State and local governments. Where such actions have federalism implications, agencies are directed to provide a statement for inclusion in the preamble to the regulations describing the agency's considerations in terms of the three categories called for under section (6)(b)(2)(B) of Executive Order 13121. Prior Consultation With State Officials Prior to drafting the final rule, a comment period was provided to permit State and local agencies and the general public the opportunity to comment on the proposed changes. Further, because the WIC Program is a State-administered, federally funded program, FNS regional offices have formal and informal discussions with State and local officials on an ongoing basis regarding program and policy issues. This arrangement allows State and local agencies to provide comments that form the basis for many discretionary decisions in this and other WIC Program rules. We have also received oral and written requests for policy guidance on the implications of the Food Delivery Systems Final Rule from State agencies that deliver WIC services. Nature of Concerns and the Need To Issue This Rule This rule addresses the need to assure the soundness of infant formula rebate solicitations and contracts. With limited exceptions, as provided for at 42 U.S.C. 1786(h)(8) and WIC regulations at 7 CFR 246.16a(a), all State agencies must continuously operate a cost containment system for infant formula. Some also have rebates for other supplemental foods, such as infant juice and cereal. As a result, in Fiscal Year 2006, State agencies received approximately $1.7 billion in rebates on infant formula and other supplemental foods purchased by WIC participants. The rebates that State agencies receive allow the WIC Program to serve an estimated 2 million additional participants annually. Infant formula manufacturers have questioned the inclusion of requirements to provide free infant formula and other items in infant formula rebate bid solicitations. Receipt of free infant formula reduces the amount of formula that the State agency potentially could purchase under rebate contracts and may lower the level of rebate bids received. A lower rebate could lead to a reduction in the number of eligible persons that the WIC Program is able to serve. This rule modifies the requirements for rebate solicitations and contracts to address this issue and thereby helps to maintain sound infant formula cost containment systems. Technical changes were made to 7 CFR 246.16a due to revisions made to the WIC Food Packages, published in the **Federal Register** December 6, 2007. This rule updates regulatory citations contained in 7 CFR 246.16a that refer to 7 CFR 246.10. The rule also addresses two issues affecting WIC vendors. First, State agencies have questioned the need to offer a full administrative review to vendors who receive a WIC civil money penalty as a result of FSP disqualification. State agencies are required to impose a civil money penalty when they determine that an authorized vendor that has been disqualified from the FSP is needed to ensure participant access to supplemental foods. In responding to this issue, the rule seeks to assure a vendor's right to due process while encouraging the most cost-effective use of State agency resources. In addition, while implementing the WIC Food Delivery Systems Final Rule, State agencies have sought approval to release basic vendor information that the rule designates as confidential. This rule seeks to accommodate State agency requests to release such information, while preserving the overall confidentiality of vendor information. Extent To Which Those Concerns Have Been Met The rule would substantially resolve the vendor management problems State agencies have identified. It increases a State agency's flexibility in conducting appeals of a civil money penalty imposed in lieu of reciprocal disqualification from the WIC Program, and in disclosing vendor information as part of sound program management. It also supports the integrity of State agency infant formula rebate systems by prohibiting gratis provision requirements in infant formula rebate solicitations and contracts. Executive Order 12988 This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is intended to have preemptive effect with respect to any State or local laws, regulations or policies which conflict with its provisions or which would otherwise impede its full implementation. This rule is not intended to have retroactive effect. Prior to any judicial challenge to the provisions of this rule or the application of its provisions, all applicable administrative procedures must be exhausted. Civil Rights Impact Analysis FNS has reviewed this final rule in accordance with Departmental Regulation 4300-4, “Civil Rights Impact Analysis,” to identify and address any major civil rights impacts this rule might have on minorities, women, and persons with disabilities. All data available to FNS indicate that protected individuals have the same opportunity to participate in the WIC Program as non-protected individuals. FNS specifically prohibits State and local government agencies that administer the WIC Program from engaging in actions that discriminate against any individual in any of the protected classes; see 7 CFR 246.8(a) for the non-discrimination policy of the WIC Program. Where State agencies have options, and they choose to implement a certain provision, they must implement it in such a way that it complies with the regulations at 7 CFR 246.8. Paperwork Reduction Act The Paperwork Reduction Act of 1995 (44 U.S.C. Chap. 35; see 5 CFR 1320) requires that the Office of Management and Budget
(OMB)approve all collections of information by a Federal agency before they can be implemented. Respondents are not required to respond to any collection of information unless it displays a current valid OMB control number. This rule does not contain information collection requirements subject to approval by the Office of Management and Budget under the Paperwork Reduction Act of 1995. E-Government Act Compliance FNS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. Background On July 27, 2005, the Department published a proposed rule at 70 FR 43332, concerning revisions of miscellaneous vendor-related provisions of the WIC Program regulations. The comment period ended on November 25, 2005. Thirteen comment documents were submitted to the Department to provide comments on the proposed revisions. We greatly appreciate these comments, all of which were carefully considered in the development of this final rule. Following is a discussion of each provision as proposed, the comments received, and an explanation of the provisions set forth in this final rule. 1. *Gratis Provisions in Infant Formula Rebate Solicitations and Contracts (7 CFR 246.16a(j)(4))* The Department proposed prohibiting the requirement of gratis infant formula or other items in infant formula rebate solicitations and contracts. The receipt of free infant formula or other items by the State agency from the manufacturer may lower the level of rebate bids received. Therefore, the Department proposed to amend 7 CFR 246.16a(j), by adding to a list of provisions that are prohibited to be included in cost containment contracts the requirement for gratis infant formula and other items. All but one of the comment letters received supported this proposal. Some of the comment letters supporting the provision also recommended allowing:
(1)Exceptions from the gratis prohibition for labels and other inexpensive educational materials that are germane to the contract;
(2)gratis provisions only for new brands of infant formula introduced to participants as a result of the bid process;
(3)State agencies that choose to provide sample infant formula to pay for it at the net contract price;
(4)capping the purchase amount of infant formula samples to no more than one percent of the previous year's volume of infant formula; and
(5)gratis provisions as voluntary components of bids which would not be used in evaluating the bidder's qualifications, or economics of the bid. One commenter opposing the provision agreed that the elimination of sample or gratis formula would result in lower cost to the manufacturer, more favorable bids, and ultimately lower WIC food costs. However, the commenter stated that formula is needed by clinics for formula challenges and substitutions for a different type of formula when an infant cannot tolerate the formula initially issued. This commenter requested that the Department require State agencies to evaluate the levels and uses of gratis infant formulas to ensure cost effectiveness and to ensure the needs of infant participants are addressed. The Department has considered these recommendations and discuses them below. One commenter requested State agencies be allowed to purchase limited quantities of sample infant formula. Currently, WIC State agencies are allowed to pay for sample infant formula for clinics to use for formula challenges and substitutions. Contracts can include a provision to allow a State agency to purchase sample formulas at the same net cost as other contract infant formulas. WIC Program funds may not be used to purchase formula for applicants or other individuals who are not WIC participants (7 CFR 246.14(b)(1)(i)). Therefore, State agencies that choose to purchase sample infant formula would be expected to ensure that such formula is issued to a WIC participant only. Commenters also suggested State agencies be given the authority to request the manufacturer provide labels and mixing instructions for safe handling and safe storage of its products. It is not the intent of this regulation to prohibit such practices by State agencies; however, such items may not be included as a required provision in an infant formula rebate solicitation and contract. Several commenters suggested State agencies be required to limit the purchase amount of infant formula samples. If a State agency purchases infant formula to be distributed as samples, or receives sample infant formula voluntarily from an infant formula manufacturer, State agencies may want, as a prudent business decision, to consider capping the amount of sample infant formula that is issued, or to establish other procedures for the control and issuance of sample infant formula. However, no changes will be added to this rule requiring such a cap. FNS continues to believe that contract solicitations should not require any gratis infant formulas, even if these gratis formulas are not included as part of the bid evaluation. Such provisions are considered inappropriate and could have the effect of reducing rebate savings not only to individual State agencies, but also to the WIC Program nationally. Accordingly, after careful consideration of the comments received, 7 CFR 246.16a(j)(4) in this final rule remains as proposed. 2. Abbreviated Administrative Reviews (7 CFR 246.18(a)(1)(ii)) The Department proposed to require a State agency to offer an abbreviated administrative review when a vendor appeals a WIC CMP imposed in lieu of a disqualification that stems from an FSP disqualification unless, as in the case of all adverse actions subject to abbreviated administrative review, the State agency decides to provide a full administrative review. As a result of the WIC/FSP Vendor Disqualification Rule, 64 FR 13311, March 18, 1999, a reciprocal disqualification imposed by a WIC State agency, *i.e.* , a disqualification based on an FSP disqualification, is not currently subject to administrative or judicial review under the WIC Program. However, if the State agency determines that the vendor is needed to ensure participant access to supplemental foods, the State agency must impose a CMP in lieu of a disqualification as provided in 7 CFR 246.12(l)(1)(ix); under 7 CFR 246.18(a)(1)(i), the imposition of a CMP in lieu of disqualification is subject to a full administrative review. The Department took the position that a CMP imposed in lieu of a reciprocal disqualification does not warrant a full administrative review, and instead should be subject to an abbreviated administrative review, because at issue are two factual questions only, namely, whether the vendor has been disqualified from FSP and whether the State agency correctly calculated the amount of the CMP. Answers to these questions can easily be established within the context of an abbreviated review; an abbreviated review would be the more cost-effective means of honoring the vendor's due process protections. This would be consistent with the adverse actions for which WIC Program regulations currently allow abbreviated reviews. All commenters supported the proposal, although one commenter recommended that adverse actions for two other reasons also be made subject to abbreviated administrative review, including denial of authorization based on an absence of FSP authorization and disqualification resulting from failure to pay a CMP. The Department agrees that denial of authorization based on an absence of FSP authorization should also be subject to an abbreviated administrative review. Like termination based on change of location, or denial of an application submitted outside of the timeframe for submitting applications, which are subject to abbreviated administrative review under the current regulations, determination of whether an applicant vendor is currently FSP-authorized is also a narrow factual determination. Many WIC State agencies require FSP authorization as a selection criterion for WIC authorization. Although not a mandatory selection criterion, requiring FSP authorization as a selection criterion for WIC authorization helps the WIC State agency to screen vendor applicants regarding common requirements of the two programs such as business integrity and valid documentation of ownership. However, unlike the absence of FSP authorization, failure to pay a CMP may involve issues that are beyond a narrow factual determination. Therefore, the Department will consider seeking public comment on whether an abbreviated administrative review rather than a full administrative review should be provided for failure to pay a CMP in a future rulemaking. Accordingly, 7 CFR 246.18(a)(1)(ii) in this final rule remains as proposed except that denial of authorization based on an absence of FSP authorization will be included as an additional adverse action which is subject to an abbreviated administrative review. *3. Confidentiality of Vendor Information (7 CFR 246.26(e))* The current 7 CFR 246.26(e) restricts the use or disclosure of information that individually identifies a vendor, except for the vendor's name, address and authorization status, to persons directly connected with the administration or enforcement of WIC or FSP; persons directly connected with the administration or enforcement of any Federal or State law; or vendors who are subject to an adverse action. The Department proposed to amend 7 CFR 246.26(e) to expand the types of vendor information allowed for general release and thus not be subject to confidentiality restrictions, including the vendor's telephone number, Web site and e-mail address, WIC identification number, and store type. The term “store type” refers to ordinary terms for retail food stores, such as “grocery store,” “chain store,” and “convenience store,” but not to specialized regulatory terms such as “above-50-percent vendor” or “WIC-only store”. “Store type” was included in the preamble of the proposed rule, but inadvertently omitted from the proposed rule itself. The Department believed that this increased information would allow WIC State agencies to provide participants with vendors' telephone numbers and Web sites and/or e-mail addresses to assist them with locating authorized vendors in their neighborhood or local service area, and that knowing a vendor's store type also would help participants to determine where to transact their food instruments. Further, the Department proposed to allow WIC State agencies to issue public notices of vendor disqualifications (including the length of disqualification and the reason for the disqualification) and to provide this information to authorized vendors and program participants; the Department believed that issuing public notices of WIC vendor disqualifications would deter vendor fraud and abuse in the WIC Program. The comments were generally supportive, but requested several clarifications and revisions. Many of the commenters objected to release of the vendor identification number, contending that this would not assist the participants or public, and may lead to fraud, *e.g.* , creation of a counterfeit vendor stamp. Also, one of the commenters asserted that knowing the store type of a vendor would not help participants to choose where to shop. Finally, one of the commenters stated that the name of the owner should be released, since this would assist the State health licensing process. The Department agrees that the vendor identification number would be of little value, and that making WIC vendor identification numbers public could lead to fraud. However, the Department cannot consider making the name of the owner available to the general public in this final rule, since the name of the owner was not specified in 7 CFR 246.26(e) of the proposed rule. Removing the confidentiality of such personal information should not be undertaken without an opportunity for comment. Also, the Department disagrees that the store type should not be made available to the general public, since, unlike the name of the owner, there is no privacy issued involved. Accordingly, the vendor identification number and the name of the owner are not included in 7 CFR 246.26(e) of this final rule, while the store type of the vendor is included in 7 CFR 246.26(e). One of the commenters recommended that 7 CFR 246.26(e)(2) should be revised to include local ordinances as well as Federal and State laws regarding the persons directly connected with administration or enforcement, because a city may be responsible for licensing grocery stores, and also because the WIC State agency could benefit by having another source of information on ownership. Another commenter asserted that FNS should clarify that infant formula manufacturers participating in the cost containment process are persons directly connected with the administration or enforcement of the WIC Program in 7 CFR 246.26(e)(1). This commenter pointed out that these companies play a unique and important role regarding WIC, and thus need to know how the retail presence of their products will be impacted by the acceptance of a bid in order to reduce uncertainties which might impede aggressive bidding, and also need to ensure that participants have access to infant formula when a State agency transitions to a new contractor or during periods of inventory shortages. The information of interest includes only the names of the top 20 retailers and their associated percentage of WIC volume. The Department agrees that the State agency should be able to share confidential vendor information with persons who are directly connected with the administration or enforcement of local laws or ordinances on such matters as licensing grocery stores, under agreement with the State agency restricting third party disclosure. Accordingly, 7 CFR 246.26(e)(2) of this final rule includes the reference to local laws and ordinances as well as Federal and State laws. However, the Department does not agree that infant formula manufacturers are persons directly connected with the administration or enforcement of the WIC Program within the meaning of 7 CFR 246.26(e)(1). Although infant formula manufacturers have a unique and important role regarding the WIC Program, these manufacturers do not administer or enforce the Federal, State, or local laws, rules, regulations, or ordinances which govern the WIC Program. Their contracts with WIC State agencies do not include responsibilities for such programmatic activities as the certification of participants, the authorization of vendors, the operation of State agency Management Information Systems, the conducting of audits or investigations on behalf of State agencies, or any other activities applying the Federal WIC-related laws, rules, and regulations, or for such responsibilities related to State or local laws or ordinances. The redemption volume of individual WIC vendors is confidential vendor information under 7 CFR 246.26(e), and thus may not be disclosed by WIC State agencies to infant formula manufacturers under 7 CFR 246.26(e)(1) because infant formula manufacturers are not persons directly connected with the administration or enforcement of the WIC Program. Finally, several commenters expressed reservations or recommended restrictions regarding State agencies issuing public notices of WIC vendor disqualifications. One of the commenters objected to release of the disqualification information because the proposed provision is so broad that it could compromise investigative techniques and lead to release of investigative reports, and that release of derogatory information could unfairly damage the reputation of a vendor who later prevails on appeal. One commenter objected to release of the disqualification information because this may be used to justify an expansive discovery process in legal proceedings regarding information on vendors other than the vendor seeking discovery, recommending that the proposed provision needs to be more specific and should cover CMPs as well as disqualifications. Another commenter asserted that there should be equal treatment for participants and program officials, *i.e.* , public notification of participants and program officials found guilty of fraud; this commenter also asserted that such notification should only occur after due process has been exhausted. The Department agrees with many of these concerns. To accommodate all of these issues, disqualification information is addressed by a new 7 CFR 246.26(e)(4) in this final rule. This new provision explicitly provides that a State agency may release such information at its discretion, that the imposition of CMPs may be included as well as disqualifications, and that State agencies are only permitted to release the vendor's name, address, length of the disqualification or amount of the CMP, and a summary of the reason(s) for such sanction provided in the notice of adverse action. Further, the new provision provides that such information may not be disclosed unless the vendor's right to appeal through the judicial as well as administrative review procedures has been exhausted. Finally, under this new provision, this information may only be disclosed to other authorized vendors or vendor applicants, since such disclosure is intended to deter vendor violations, not the violations of participants or program officials. If a State agency does not view this revised language as meeting all of its concerns, then the State agency may exercise its discretion to not issue such notices. List of Subjects in 7 CFR Part 246 Food assistance programs, Food donations, Grant programs—social programs, Indians, Infants and children, Maternal and child health, Nutrition, Nutrition education, Public assistance programs, WIC, Women. Accordingly, for the reasons set forth in the preamble, 7 CFR part 246 is amended as follows: PART 246—SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS AND CHILDREN 1. The authority citation for part 246 continues to read as follows: Authority: 42 U.S.C. 1786. 2. In § 246.16a: a. Amend paragraph (c)(3)(i), (c)(3)(ii)(A) and
(B)by removing the reference “§ 246.10(c)(1)(i)” wherever it appears and replacing it with “§ 246.10(e)(1)(iii) and § 246.10(e)(2)(iii)”. b. Amend paragraph (c)(4)(i) by removing the reference “§ 246.10(c)(1)(vi)” and replacing it with “§ 246.10(e)(9)(Table1))”. c. Amend paragraph
(e)by removing the reference “§ 246.4(a)(14)(xi)” and replacing it with “§ 246.4(a)(14)(x)”. d. Amend paragraph (j)(2) by removing the reference “§ 246.10(f); or” and replacing it with “§ 246.10(g);”. e. Amend paragraph (j)(3) by removing the period at the end of the paragraph and adding in its place a semicolon followed by the word “or”; and f. Add paragraph (j)(4) to read as follows: § 246.16a Infant formula cost containment.
(j)* * *
(4)Require infant formula manufacturers to provide gratis infant formula or other items. 3. In § 246.18, add new paragraphs (a)(1)(ii)(I) and (a)(1)(ii)(J) to read as follows: § 246.18 Administrative review of State agency actions.
(a)* * *
(1)* * *
(ii)* * *
(I)A civil money penalty imposed in lieu of disqualification based on a Food Stamp Program disqualification under § 246.12(l)(1)(vii) and,
(J)Denial of an application based on a determination of whether an applicant vendor is currently authorized by the Food Stamp Program. 4. In § 246.26: a. Amend the first sentence of the introductory text of paragraph
(e)by removing the words “and authorization status” and by adding, in their place, the words “, telephone number, Web site/e-mail address, store type, and authorization status”; b. Amend paragraph (e)(2) by adding the words “or local law or ordinance” at the end of the first sentence; and, c. Add a new paragraph (e)(4) to read as follows: § 246.26 Other provisions.
(e)* * *
(4)At the discretion of the State agency, all authorized vendors and vendor applicants regarding vendor sanctions which have been imposed, identifying only the vendor's name, address, length of the disqualification or amount of the civil money penalty, and a summary of the reason(s) for such sanction provided in the notice of adverse action. Such information may be disclosed only following the exhaustion of all administrative and judicial review, in which the State agency has prevailed, regarding the sanction imposed on the subject vendor, or the time period for requesting such review has expired. Dated: April 10, 2008. Roberto Salazar, Administrator, Food and Nutrition Service. [FR Doc. E8-8767 Filed 4-22-08; 8:45 am] BILLING CODE 3410-30-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0411; Directorate Identifier 2008-NM-061-AD; Amendment 39-15488; AD 2008-09-07] RIN 2120-AA64 Airworthiness Directives; Boeing Model 757 Airplanes and Model 767-200, 767-300, and 767-300F Series Airplanes AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule; request for comments. SUMMARY: We are adopting a new airworthiness directive
(AD)for all Boeing Model 757 airplanes and Model 767-200, 767-300, and 767-300F series airplanes. This AD requires revising the Limitations section of the airplane flight manual to advise the flight crew of procedures to follow to ensure that a fuel filter impending bypass condition due to gross fuel contamination is detected in a timely manner. This AD was prompted by an error in the operating program software
(OPS)of the engine indication and crew alerting system (EICAS). The error prevents the display of an advisory message to the flight crew of a left engine fuel filter contamination and imminent bypass condition, which may indicate an imminent multiple engine thrust loss or engine malfunction event due to fuel contamination. We are issuing this AD to prevent malfunction and thrust loss on both engines, which could result in a forced off-airport landing. DATES: This AD is effective May 8, 2008. We must receive comments on this AD by June 23, 2008. ADDRESSES: You may send comments by any of the following methods: • Federal eRulemaking Portal: Go to *http://www.regulations.gov.* Follow the instructions for submitting comments. • *Fax:* 202-493-2251. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Hand Delivery:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.gov* ; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. FOR FURTHER INFORMATION CONTACT: Judy Coyle, Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)917-6497; fax
(425)917-6590. SUPPLEMENTARY INFORMATION: Discussion We have been advised that an operator discovered an error in the Engine Indication and Crew Alerting System (EICAS) operating program software
(OPS)Version 6. This software error prevents the display of the “L ENG FUEL FILT” advisory message to the flight crew. This message was intended to be displayed if an impending clogging condition of the left engine fuel filter exists. (The corresponding message for the right engine functions normally.) Boeing has determined that this software error is isolated to the EICAS OPS Version 6. This software is currently approved for installation on all Boeing Model 757 airplanes, and Model 767-200, 767-300, and 767-300F series airplanes. (Model 767-400ER series airplanes use different software.) OPS Version 6 was approved in mid-2007 for production and retrofit installation. Boeing's records show that the majority of the affected airplanes currently have Version 6 software installed. Absence of an engine fuel filter bypass indication for each engine eliminates the only effective advance warning the flight crew will receive of potential engine malfunction due to a gross fuel contamination event on the airplane. Without such advance warning, malfunction and thrust loss on both engines due to fuel contamination could cause a forced off-airport landing. FAA's Determination and Requirements of This AD We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the(se) same type design(s). This AD requires revising the Limitations section of the airplane flight manual
(AFM)to advise the flight crew of procedures to follow to ensure that a fuel filter impending bypass condition due to gross fuel contamination is detected in a timely manner. The actions specified by paragraph
(f)of this AD are not required when all affected airplanes in an operator's fleet have been verified by the operator to have an EICAS computer with a particular part number and EICAS OPS versions other than Version 6 software. This exception is currently available for Model 757 and 767 passenger airplanes and for new production freighter airplanes, but will be available for non-production-modified freighter airplanes only when OPS versions later than Version 6 software become available. Non-production-modified freighter airplanes include, but are not limited to, Model 757 airplanes modified in accordance with Supplemental Type Certificate
(STC)ST01920LA, and Model 767 series airplanes modified in accordance with design approvals granted to Boeing for the Boeing Converted Freighter
(BCF)or Special Freighter
(SF)configurations. Only OPS Version 6 software or a later OPS version was approved by the FAA for use on non-production-modified freighter airplanes; this is because cargo door indications required for certification of those freighter conversion modifications were introduced at Version 6. FAA's Justification and Determination of the Effective Date Because of our requirement to promote safe flight of civil aircraft, and thus the critical need to ensure that the flight crew has procedures to follow to ensure that a fuel filter impending bypass condition due to gross fuel contamination is detected in a timely manner, and because of the short compliance time involved with this action, this AD must be issued immediately. Because an unsafe condition exists that requires the immediate adoption of this AD, we find that notice and opportunity for prior public comment hereon are impracticable and that good cause exists for making this amendment effective in less than 30 days. Comments Invited This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments before it becomes effective. However, we invite you to send any written data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2008-0411; Directorate Identifier 2008-NM-061-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments. We will post all comments we receive, without change, to *http://www.regulations.gov,* including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs” describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. *For the reasons discussed above, I certify that this AD:*
(1)Is not a “significant regulatory action” under Executive Order 12866;
(2)Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
(3)Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. You can find our regulatory evaluation and the estimated costs of compliance in the AD Docket. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new AD: **2008-09-07 Boeing:** Amendment 39-15488. Docket No. FAA-2008-0411; Directorate Identifier 2008-NM-061-AD. Effective Date
(a)This airworthiness directive
(AD)is effective May 8, 2008. Affected ADs
(b)None. Applicability
(c)This AD applies to all Boeing Model 757-200, -200PF, -200CB, and -300 series airplanes, and Model 767-200, 767-300, and 767-300F series airplanes, certificated in any category. Unsafe Condition
(d)This AD was prompted by an error in the operating program software
(OPS)of the engine indication and crew alerting system (EICAS). The error prevents the display of an advisory message to the flight crew of a left engine fuel filter contamination and imminent bypass condition, which may indicate an imminent multiple engine thrust loss or engine malfunction event due to fuel contamination. We are issuing this AD to prevent malfunction and thrust loss on both engines, which could result in a forced off-airport landing. Compliance
(e)Comply with this AD within the compliance times specified, unless already done. Revision of Airplane Flight Manual
(f)Within 30 days after the effective date of this AD, revise the Limitations section of the applicable AFM to include the following. This may be done by inserting a copy of this AD into the AFM. “If the STATUS cue shows while on the ground after engine start or during flight, select the status page on the secondary EICAS display, and verify the “L ENG FUEL FILT” message is not shown. If the “L ENG FUEL FILT” message is not shown on the status page, the secondary engine parameters may be reselected on the secondary EICAS display, or the display may be blanked. If the “L ENG FUEL FILT” message is shown on the status display, accomplish the ENGINE FUEL FILTER non-normal checklist as published in the Boeing Quick Reference Handbook. If on the ground, check the Dispatch Deviations Guide (DDG), or operator equivalent. In the event that the status level “L ENG FUEL FILT” and advisory level “R ENG FUEL FILT” messages are simultaneously shown, an impending fuel filter bypass condition exists on both engines. With both messages shown, airplane fuel system contamination may be present and may result in erratic engine operation or flameout. Further flight crew action in response to either or both the “L ENG FUEL FILT” status-level message and the “R ENG FUEL FILT” advisory level messages being shown are not established by Boeing or the FAA. Any further flight crew action should be determined by individual operator policy. Boeing policy on flight crew use of status-level messages has not changed. After engine start, any condition having an adverse effect on safe continuation of the flight appears as an EICAS alert message (Warning, Caution, or Advisory). If other status-level messages are shown as a consequence of complying with these temporary operating instructions, the flight crew should respond in accordance with the appropriate operator policy. Dispatch of the airplane with an inoperative EICAS display unit is prohibited.
(g)If all affected airplanes in an operator's fleet have been verified by the operator to have EICAS computer part number S242N701-1001 and only EICAS OPS versions other than Version 6 software that are FAA approved for that airplane, then accomplishment of the actions specified in paragraph
(f)of this AD is not required. Alternative Methods of Compliance (AMOCs) (h)(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, ATTN: Judy Coyle, Aerospace Engineer, Propulsion Branch, ANM-140S, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)917-6497; fax
(425)917-6590; has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19.
(2)To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO. Material Incorporated by Reference
(i)None. Issued in Renton, Washington, on April 14, 2008. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-8653 Filed 4-22-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No FAA-2007-29260; Airspace Docket 07-ASO-24] Establishment of Class E Airspace; Winona, MS AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This action establishes Class E airspace at Winona, MS. An Area Navigation
(RNAV)Global Positioning System
(GPS)Standard Instrument Approach Procedures
(SIAP)Runways
(RWY)03-21 has been developed for Winona-Montgomery County Airport and as a result, controlled airspace extending upward from 700 feet Above Ground Level
(AGL)is needed to contain the SIAP and for Instrument Flight Rule
(IFR)operations at Winona-Montgomery County Airport. The operating status of the airport will change from Visual Flight Rules
(VFR)to include IFA operations concurrent with the publication of the SIAP. DATES: 0901 UTC, June 5, 2008. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments. FOR FURTHER INFORMATION CONTACT: Melinda Giddens, System Support, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone
(404)305-5610. SUPPLEMENTARY INFORMATION: History On January 31, 2008, the FAA proposed to amend part 71 of the Federal Aviation Regulations (14 CFR part 71) by establishing Class E at Winona, MS, (73 FR 5776). This action provides adequate Class E airspace for IFR operations at Winona-Montgomery County Airport. Designations for Class E airspace are published in FAA Order 7400.9R, signed August 15, 2007, and effective September 15, 2007, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order. Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No comments objecting to the proposal were received. The area will be depicted on Aeronautical Charts for pilot reference. The Rule The FAA is amending Part 71 of the Code of Federal Regulations (14 CFR part 71) to establish Class E airspace at Winona, MS, to provide controlled airspace required to support the Area Navigation
(RNAV)Global Positioning System
(GPS)Standard instrument Approach Procedures
(SIAP)Runways
(RWY)03/21 that were developed for Winona-Montgomery County Airport. The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore,
(1)is not a “significant regulatory action” under Executive Order 12866;
(2)is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and
(3)does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace at Winona, MS. List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (air). Adoption of the Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows: PART 71—DESIGNATION OF CLASS A, CLASS B, CLASS C, CLASS D, AND CLASS E AIRSPACE AREAS; AIRWAYS; ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389. § 71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.9R, Airspace Designations and Reporting Points, signed August 15, 2007, and effective September 15, 2007, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ASO MS E5 Winona, MS [New] Winona-Montgomery County Airport, MS (Lat. 33°27′54″ N., long. 89°43′48.8″ W.) That airspace extending upward from 700 feet above the surface of the Earth within a 6.9-mile radius of Winona-Montgomery County Airport. Issued in College Park, Georgia, on April 7, 2008. Kathy Swann, Acting Manager, System Support Group, Eastern Service Center, Air Traffic Organization. [FR Doc. E8-8578 Filed 4-22-08; 8:45 am] BILLING CODE 4910-13-M DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 18 CFR Part 39 [Docket Nos. AD08-6-000 and RM05-30-000] Rules Concerning Certification of the Electric Reliability Organization; and Procedures for the Establishment, Approval, and Enforcement of Electric Reliability Standards; Statement of Administrative Policy on Processing Reliability Notices of Penalty and Order Revising Statement in Order No. 672 Issued April 17, 2008. AGENCY: Federal Energy Regulatory Commission, DOE. ACTION: Final Rule: Statement of Administrative Policy. SUMMARY: On February 3, 2006, the Federal Energy Regulatory Commission issued a Final Rule (Order No. 672) implementing Subtitle A (Reliability Standards) of the Electricity Modernization Act of 2005, which is Title XII of the Energy Policy Act of 2005 (EPAct). The Commission is issuing a policy statement that adopts administrative policy on Commission review of notices of penalty for violation of Reliability Standards and that modifies Order No. 672. Dates: *Effective Date:* April 17, 2008. FOR FURTHER INFORMATION CONTACT: Roger P. Morie, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426,
(202)502-8446. Christy Walsh (Legal Information), Office of the General Counsel, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426,
(202)502-6523. SUPPLEMENTARY INFORMATION: *Before Commissioners:* Joseph T. Kelliher, Chairman; Suedeen G. Kelly, Marc Spitzer, Philip D. Moeller, and Jon Wellinghoff. 1. On February 3, 2006, the Commission issued a Final Rule (Order No. 672), 1 implementing Subtitle A (Reliability Standards) of the Electricity Modernization Act of 2005, which is Title XII of the Energy Policy Act of 2005. 2 Among other things, Order No. 672 amended the Commission's regulations to implement section 215(e) of the Federal Power Act (FPA), which authorizes the Electric Reliability Organization
(ERO)to impose a penalty for a violation of a Reliability Standard by a user, owner or operator of the Bulk-Power System, subject to an opportunity for Commission review. 3 In this order, the Commission adopts this statement of administrative policy on Commission review of these penalties. 4 In addition, the Commission modifies our statement in Order No. 672 that any settlement of an alleged violation of a Reliability Standard that the ERO files with the Commission should be filed for information purposes only and that these settlements will not be subject to Commission review pursuant to section 39.7(e) of our regulations. 5 Any settlement filed by the ERO after the date of this order will be subject to Commission review pursuant to section 39.7(e), although the Commission continues to encourage these settlements and expects that it will normally allow ERO or Regional Entity settlements to become effective. 1 *Rules Concerning Certification of the Electric Reliability Organization; Procedures for the Establishment, Approval, and Enforcement of Electric Reliability Standards,* Order No. 672, FERC Stats. & Regs. ¶ 31,204 (2006), *order on reh'g* , Order No. 672-A, FERC Stats. & Regs. ¶ 31,212 (2006). 2 Public Law No. 109-58, Title XII, Subtitle A, 119 Stat. 594, 941, codified at 16 U.S.C. 824o (Supp. V 2005). 3 These implementing regulations are found in Part 39 of our regulations, 18 CFR Part 39 (2007). 4 FPA section 215(e)(3) empowers the Commission itself to impose a penalty against a user, owner or operator for a violation of a Reliability Standard. This order does not address the Commission's procedures for imposing these penalties. The Commission discussed these procedures in *Statement of Administrative Policy Regarding the Process for Assessing Civil Penalties* , 117 FERC ¶ 61,317, at P 5 & n.15 (2006). 5 *See* Order No. 672 at P 598. I. Background 2. Pursuant to FPA section 215(e)(1), 6 the North American Electric Reliability Corporation (NERC), in its capacity as the nation's ERO, 7 may impose a penalty on a user, owner or operator of the Bulk-Power System for a violation of a Reliability Standard approved by the Commission. Pursuant to FPA section 215(e)(4), 8 the Commission authorized NERC to delegate authority to impose such penalties to eight Regional Entities through Commission-approved Delegation Agreements. 9 The Commission also approved, subject to further modifications, NERC's Compliance Monitoring and Enforcement Program (CMEP), which establishes procedures for Regional Entities to impose penalties and for NERC to review them, whether a registered entity appeals a Regional Entity determination, agrees not to contest it, or enters into a settlement with respect to the penalty. 10 NERC itself may also impose a penalty. 6 16 U.S.C. 824o(e)(1) (Supp. V (2005)). 7 *North American Electric Reliability Corp.* , 116 FERC ¶ 61,062 *(ERO Certification Order), order on reh'g and compliance,* 117 FERC ¶ 61,126 (2006). 8 16 U.S.C. 824o(e)(4) (Supp. V (2005)). 9 *North American Electric Reliability Corp.,* 119 FERC ¶ 61,060 *(Delegation Agreement Order), order on reh'g,* 120 FERC ¶ 61,260 (2007), *order on responsive filing,* 122 FERC ¶ 61,245
(2008)( *Second Delegation Agreement Order* ). The Regional Entity Delegation Agreements went into effect on June 5, 2007. *See Delegation Agreement Between the North American Electric Reliability Corp. and Texas Regional Entity, a division of ERCOT,* 119 FERC ¶ 61,232 (2007). 10 *See id.* The relevant CMEP provisions are sections 5.1 through 5.6. 3. FPA section 215(e)(2) provides that a penalty NERC or a Regional Entity imposes may take effect no earlier than 31 days after NERC files with the Commission a notice of penalty and the record of proceedings. 11 FPA section 215(e)(2) further states, “Such penalty shall be subject to review by the Commission, on its own motion or upon application by the user, owner or operator that is the subject of the penalty filed within 30 days after the date such notice is filed with the Commission.” 11 16 U.S.C. 824o(e)(2) (Supp. V (2005)). *See also* 18 CFR 39.7(e). 4. In Order No. 693, the Commission approved 83 Reliability Standards that NERC proposed. 12 These Reliability Standards generally became effective on June 18, 2007. The Commission directed in Order No. 693 that NERC and the Regional Entities, as a matter of enforcement discretion, focus their resources on the most serious violations during an initial period through December 31, 2007, and that this discretion should apply to all users, owners and operators of the Bulk-Power System. 13 The Commission expects that, in due course, NERC will file notices of penalty with respect to certain violations of Reliability Standards that occurred during the June 18 to December 31, 2007 initial period. The Commission further expects that NERC will file notices of penalty representing settlements entered into by it or a Regional Entity of violations that occurred or are alleged to have occurred during this period. The Commission also expects that, in due course, NERC will file notices of penalty for violations that occurred or are alleged to have occurred after this initial six-month period. Accordingly, the Commission believes that an explanation of how it plans to process any notice of penalty filed by NERC will afford entities identified in notices of penalty, and the electric industry as a whole, increased transparency into the Commission's enforcement processes involving Reliability Standards. 12 *Mandatory Reliability Standards for the Bulk-Power System,* Order No. 693, FERC Stats. & Regs. ¶ 31,242, at P 1 (2007), *order on reh'g,* Order No. 693-A, 120 FERC ¶ 61,053 (2007). The Commission subsequently approved other Reliability Standards. *North American Electric Reliability Corp.,* 119 FERC ¶ 61,260
(2007)(approving eight regional standards proposed by the Western Electricity Coordinating Council); Facilities *Design, Connections and Maintenance Reliability Standards* (Order No. 705), 121 FERC ¶ 61,296 (2007); *Mandatory Reliability Standards for Critical Infrastructure Protection* (Order No. 706), 122 FERC ¶ 61,040 (2008). 13 Order No. 693 at P 222. II. Commission Review of ERO-Approved Penalties 5. Pursuant to section 39.7(e)(1) of our regulations, an entity subject to a notice of penalty may file an application for review of it within 30 days of the date NERC files the notice of penalty. 14 Any answer, intervention or comment to an application for review of a proposed penalty must be filed within 20 days after the application is filed, unless otherwise ordered by the Commission. 15 If the entity subject to a proposed penalty files an application for review of the proposed penalty, the Commission will take action on that application within 60 days of the date on which it is filed, unless the Commission determines on a case-by-case basis that an alternative expedited procedure is appropriate. 16 14 18 CFR 39.7(e)(1). 15 18 CFR 39.7(e)(4). All notices of penalty will receive a docket number with an “NP” prefix, as the Commission's Secretary stated in a February 7, 2008 notice. 16 18 CFR 39.7(e)(6). The Commission may determine that an alternative time period is appropriate at any point within the “default” 60-day period that section 39.7(e)(6) establishes. If the Commission determines to extend that period in a particular proceeding, it will issue an order establishing the alternative time period. 6. In addition, any proposed penalty filed by NERC is subject to review by the Commission on its own motion within 30 days after the date on which NERC files the notice of penalty. 17 Should the Commission determine to review a proposed penalty on its own motion, it will issue an order initiating review of the proposed penalty and establishing a filing date for any answers, interventions or comments. The Commission's regulations do not state when answers, interventions and comments ordinarily would be filed if the Commission were to initiate review of a notice of penalty. However, we generally will establish the filing deadline as 20 days after the date of the Commission's order initiating a review of a proposed penalty on its own motion. Likewise, the Commission's regulations do not specify a default time period for the Commission to complete the review of a notice of penalty on its own motion. The Commission nevertheless anticipates that it would ordinarily issue a determination within 60 days of ordering that review, unless issues in a particular case require a longer period for consideration. 17 18 CFR 39.7(e)(1). 7. Section 39.7(e)(1) provides that the Commission may take action within 30 days after NERC files a notice of penalty, other than moving to review the notice of penalty, to prevent a proposed penalty from being affirmed by operation of law on the expiration of that 30-day period. For example, the Commission could issue an order stating that it requires more than 30 days to determine whether it should review a proposed penalty on its own motion. While we anticipate that the Commission will issue such orders rarely, in appropriate instances, the Commission retains the option of doing so. Such an order will not solicit answers, intervention or comments. If the Commission determines to review the notice of penalty, it will issue a subsequent order initiating review of the proposed penalty and establishing a filing deadline for any answers, intervention or comments. Should the Commission decide not to review the notice of penalty, the Commission will issue an order terminating the proceeding. The proposed penalty shall be affirmed by operation of law immediately upon the issuance of that order. 8. We wish to make clear that in an application for review of a proposed penalty filed by NERC, an entity may seek review of the amount of the proposed penalty or its type (i.e., argue that a proposed monetary penalty should be a non-monetary penalty, for example) as well as of any determinations underlying the proposed penalty, including whether a violation of a Commission-approved Reliability Standard occurred or whether there is a sufficient factual record to support any such determination. 18 Likewise, if the Commission moves to review a proposed penalty, it may review the amount or type of the proposed penalty, as well as any determinations underlying it, such as the existence of one or more violations of a Commission-approved Reliability Standard. 18 *See* Order No. 672 at P 508 (allowing the Commission to remand a penalty to the ERO for additional fact-finding proceedings). Nevertheless, for example, it would not be appropriate, absent extraordinary circumstances, for an entity that applies for a review of a notice of penalty to contest a finding of violation included in it if that entity had admitted or not contested a finding of violation, as set forth in the record of proceedings the NERC submits with a notice of penalty. Similarly, we ordinarily would look with great disfavor on an entity's attempt in an application for review to contest a fact or matter if that entity stipulated to it, as described in the record of proceedings. 9. Section 215(e)(6) of the FPA states that a penalty imposed for a violation of a Reliability Standard “shall bear a reasonable relation to the seriousness of the violation and shall take into consideration the efforts of [the registered entity] to remedy the violation in a timely manner.” 19 When reviewing a notice of penalty, whether pursuant to an application for review or on our own motion, we will conduct a *de novo* review of the record of the proceeding below to ascertain whether the record contains adequate evidence that the proposed penalty determination accords with this test. 20 We observe in this regard that FPA section 215(e)(2) states that in any proceeding to review a notice of penalty, the Commission must provide notice and an opportunity for hearing that “may consist solely of the record before the ERO and opportunity for the presentation of supporting reasons to affirm, modify, or set aside the penalty.” 21 As we stated in Order No. 672, based on this provision, we expect in most instances not to open the record set forth in or accompanying a notice of penalty to additional material from third parties. 22 19 16 U.S.C. 824o(e)(6) (Supp. V (2005)). 20 *See* Order No. 672 at P 614 ( *de novo* review is consistent with the practice of other administrative agencies that review sanctions imposed by their associated self-regulatory organizations). We concluded in the *Delegation Agreement Order* that a Regional Entity or NERC may not impose a penalty in an adjudication without concluding that the preponderance of the evidence supports the penalty. *Delegation Agreement Order* at P 146. 21 16 U.S.C. 824o(e)(2) (Supp. V (2005)). 22 Order No. 672 at P 511. In this regard, we emphasize our agreement in the *ERO Certification Order* at P 491 that NERC affords appropriate deference in its procedures to the Regional Entities' role as reliability managers and their familiarity with operating conditions by prohibiting NERC's consideration on appeal of any fact that is not in the record compiled by the relevant Regional Entity. However, the Commission retains the discretion in particular cases to permit additions to the record with respect to a notice of penalty. 23 23 See 18 CFR 39.7(e)(2) (an applicant for Commission review of a penalty in a notice of penalty may support its explanation by providing information that is not included in the ERO's record) and 39.7(e)(3) (when reviewing a notice of penalty, the Commission may “establish a hearing before an administrative law judge or initiate such further procedures as it determines to be appropriate”). However, in neither of these situations is the Commission required to admit into the record information or documents proffered by parties to the review proceeding. In particular, the Commission would look with disfavor on admitting into the record in a proceeding to review a notice of penalty documents or information that a party had an opportunity to move into the record before the Regional Entity, but failed to do so. 10. We believe that entities that are subject to Reliability Standards should have notice of the general criteria the Commission will use to determine whether it will review particular notice of penalty on its own motion. We will use the following principles in this matter. First, the Commission does not anticipate moving to review every notice of penalty that NERC files, or even most. While the Commission is required to review every notice of penalty for which a registered entity files an application for review, the Commission's limited resources would likely preclude review of all uncontested notices of penalty. Second, as described earlier, the Commission has approved NERC's CMEP as the framework for NERC's enforcement authority under section 215 of the FPA, as well as NERC's delegation of enforcement powers to Regional Entities through the Delegation Agreements. The Commission sees no general need to review each notice of penalty for which a Regional Entity has developed a record and which it has approved, and which NERC has reviewed for sufficiency and consistency. Third, the Commission recognizes that, on a continuing basis, Regional Entities and NERC retain an element of enforcement discretion similar to our own discretion in enforcement matters. 24 Reviewing every uncontested notice of penalty on our own motion would be inconsistent with this recognition and would ultimately weaken the enforcement efforts of the Regional Entities and NERC. 25 24 *See* Order No. 693 at P 225 (“The Commission agrees that, separate from our specific directive that all concerned focus their resources on the most serious violations during an initial period, the ERO and Regional Entities retain enforcement discretion as would any enforcement entity.”). 25 *Id.* (observing that NERC's Sanction Guidelines, which set forth the principles under which NERC and the Regional Entities will determine penalties, provide flexibility as to establishing the appropriate penalty within the range of applicable penalties). 11. Nonetheless, because the Commission bears ultimate responsibility for the enforcement of Reliability Standards, we may review a notice of penalty even if the registered entity that is the subject of the notice of penalty does not file an application for review. 26 In determining whether to review a notice of penalty (which will occur prior to receiving an application for review), we would look first to the apparent relative seriousness of the violation at issue in the notice of penalty. For example, we would evaluate the seriousness of a violation by the combination of violation risk factor and violation severity level that NERC has assigned and that we have approved for particular requirements of the Reliability Standards implicated in the notice of penalty. 27 We also will analyze notices of penalty to ascertain the potential risk to the reliability of the Bulk-Power System, as well as any actual harm, presented by their particular fact patterns. The more serious a violation described in a notice of penalty appears to be, the more likely it is that we would review the proposed penalty. In addition, the Commission retains the authority to review notices of penalty on its own motion to ensure that penalties are applied in a reasonably consistent manner, or to improve compliance with Reliability Standards and thereby increase the reliability of the Bulk-Power System. 28 26 It is possible that a registered entity will file an application for review of a notice of penalty after the Commission has issued an order stating that it will review the notice of penalty on its own motion. In that situation, the Commission will adhere to the procedural provisions of section 39.7(e)(4) and (e)(6) with respect to an application for review of a notice of penalty. 27 Pursuant to section 4.1 of NERC's Sanction Guidelines, NERC and Regional Entities use the intersection of the violation risk factor and violation severity level in setting the initial range of the Base Penalty Amount that is calculated in the process of determining an appropriate penalty for a particular violation. *See North American Electric Reliability Corp.* , 119 FERC ¶ 61,248, at P 74 (2007). While the Commission has approved or directed revisions to violation risk factors for all requirements of Reliability Standards it has currently approved to apply nationwide, NERC's proposed violation severity levels for these standards are currently pending before the Commission in Docket No. RR08-4-000. Pending Commission review of this filing, as an interim measure when determining penalties, NERC and Regional Entities may use existing Levels of Non-Compliance assigned to particular standards to substitute for violation severity levels. *Id.* P 79. 28 *See Second Delegation Agreement Order* at P 60 (The Commission's discretion to review penalty determinations on its own motion includes, but is broader than, ascertaining whether they clearly conflict with the goal of consistent national reliability enforcement or whether their revision is needed for oversight of Regional Entity compliance activities, citing *Delegation Agreement Order* at P 173). 12. Section 39.7(e)(3) of our regulations provides that neither an application for review of a notice of penalty nor the Commission's initiation of a review of a notice of penalty will operate as a stay of the proposed penalty unless the Commission otherwise orders, upon application by the subject of a notice of penalty or upon the Commission's own motion. Nevertheless, as a matter of policy, the Commission intends as a general matter to stay any proposed penalty under Commission review. Not doing so would require a user, owner or operator to pay a penalty that the Commission may later set aside or modify. To the extent that any proposed penalty is later affirmed by the Commission, the penalty amount must be paid with interest from the date of the stay. 13. Pursuant to section 39.7(e)(5) of our regulations, in any proceeding to review a proposed penalty, the Commission, after public notice and opportunity for hearing, may by order affirm, set aside, or modify the proposed penalty, or remand the determination of the proposed penalty, or its form or amount, to the ERO for further proceedings. Any party to the proceeding may seek rehearing of the Commission's order, as described in Rule 713 of the Commission's Rules of Practice and Procedure. 29 29 18 CFR 385.713 (2007). III. Commission Review of Settlements of Reliability Penalties by Regional Entities or NERC A. Order No. 672 14. Order No. 672 stated the ERO should file, for informational purposes only, any settlement of an alleged violation regardless of whether the agreement contains an admission by the settling user, owner or operator. While settlements will be made public, Order No. 672 provided that settlements would not be noticed for public comment; nor would they be subject to Commission review pursuant to section 39.7(e) of the Commission's regulations regarding Commission review of a notice of penalty. 30 30 Order No. 672 at P 598. The Commission presumes that a settlement will require a registered entity that is a party to forego any right to file an application for Commission review of the settlement. B. Commission Determination 15. Upon reconsideration based on our experience since Order No. 672 issued, the Commission revises its policy stated in Order No. 672 with regard to reviewing settlements of alleged violations. In modifying our policy regarding ERO and Regional Entity settlements, we note that the Commission may change its policy if it provides, as it does here, a reasoned basis for that change. 31 The Commission believes that, on reflection, our statement in Order No. 672 is not in the public interest for several reasons. First, it is contrary to Commission policy regarding settlements in other contexts. For example, pursuant to Rule 602 of the Commission's Rules of Practice and Procedure, the Commission must review written offers of settlement filed in any proceeding pending before the Commission. 32 Further, the Commission reviews settlements entered into by the Commission's Office of Enforcement. 33 Second, after issuing Order No. 672, the Commission decided that the ERO should have authority on its own motion to reject settlements into which Regional Entities have entered. 34 31 *E.g., B&J Oil and Gas* v. *FERC* , 353 F.3d 71 (D.C. Cir. 2004). 32 18 CFR 385.602(g)(3), (h)(1)(i) (2007). 33 *See, eg., Statement of Administrative Policy Regarding the Process for Assessing Civil Penalties* , 117 FERC ¶ 61,317, at P 2
(2006)(noting that “civil penalties often are negotiated as part of a stipulation and agreement resolving compliance issues” and that “[i]n such cases the civil penalty is imposed through a Commission order approving the negotiated agreement. * * *”) *See also, e.g., In re Gexa Energy, LLC* , 120 FERC ¶ 61,175 (2007); *In re Cleco Power, LLC* , 119 FERC ¶ 61,271 (2007). 34 *Delegation Agreement Order* at P 107. 16. The Commission does not believe that it should afford settlements entered into by the ERO or a Regional Entity relating to an alleged or confirmed violation of Commission-approved mandatory Reliability Standards more deference than we would afford to those entered into by the Office of Enforcement or approved by the Commission's Administrative Law Judges. Nor should the Commission abstain from reviewing settlements approved by the ERO in the manner in which it has permitted the ERO to review Regional Entity settlements. Finally, we do not believe it reasonable to treat settlements as categorically different than other notices of penalty. 17. Not allowing Commission review of a settlement would mean, for example, that an entity that does not contest a proposed penalty would nonetheless have its notice of penalty subject to review by the Commission, whereas an entity that initially contested the proposed penalty but subsequently settled with the Regional Entity would not have its settlement subject to review by the Commission. This distinction makes little sense and could actually increase litigation (in an effort to produce formal settlements) rather than reduce it. Therefore, any settlement entered into by the ERO or a Regional Entity after the date of this order will be subject to Commission review pursuant to section 39.7(e) of the Commission's regulations. 18. As a final matter, we wish to make it clear that the Commission continues to encourage settlements by Regional Entities and NERC. 35 Similar to the Commission's statement that it does not expect the ERO to reject Regional Entity settlements as a normal practice, the Commission expects that it will normally allow ERO or Regional Entity settlements to become effective. 36 35 *See ERO Certification Order* at P 479; *Delegation Agreement Order* at P 107. 36 *Id.* By the Commission. Nathaniel J. Davis, Sr., Deputy Secretary. APPENDIX FLOW CHART ILLUSTRATING NOTICE OF PENALTY PROCESSES BILLING CODE 6717-01-P ER23AP08.000 [FR Doc. E8-8745 Filed 4-22-08; 8:45 am] BILLING CODE 6717-01-C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 522 and 556 New Animal Drugs; Enrofloxacin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration
(FDA)is amending the animal drug regulations to reflect approval of a supplemental new animal drug application
(NADA)filed by Bayer HealthCare LLC. The supplemental NADA provides for use of enrofloxacin injectable solution in swine for the treatment and control of respiratory disease. DATES: This rule is effective April 23, 2008. FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: *cindy.burnsteel@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201, filed a supplement to NADA 141-068 for BAYTRIL 100 (enrofloxacin) injectable solution. The supplemental NADA provides for use of enrofloxacin injectable solution in swine for the treatment and control of swine respiratory disease
(SRD)associated with *Actinobacillus* *pleuropneumoniae* , *Pasteurella* *multocida* , *Haemophilus* *parasuis* , and *Streptococcus* *suis* . The supplemental NADA is approved as of March 14, 2008, and the regulations in 21 CFR 522.812 and 556.228 (§§ 522.812 and 556.228) are amended to reflect the approval. In addition, FDA has noticed that § 556.228 is not in alphabetical sequence in 21 CFR part 556. At this time, that section is being redesignated to correct this error. A conforming change is also being made in § 522.812 to reflect the correction in part 556. In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years of marketing exclusivity beginning on the date of approval. The agency has determined under 21 CFR 25.33(d)(5) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects 21 CFR Part 522 Animal drugs. 21 CFR Part 556 Animal drugs, Food. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 522 and 556 are amended as follows: PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: Authority: 21 U.S.C. 360b. 2. Section 522.812, is amended by revising paragraph
(c)and adding paragraph (e)(3) to read as follows: § 522.812 Enrofloxacin.
(c)*Related tolerance* . See § 556.226 of this chapter
(e)* * *
(3)*Swine* . Use the product described in paragraph (a)(2) of this section as follows:
(i)*Amount* . Administer 7.5 mg/kg of body weight once, by subcutaneous injection behind the ear.
(ii)*Indications for use* . For the treatment and control of swine respiratory disease
(SRD)associated with *Actinobacillus pleuropneumoniae* , *Pasteurella multocida* , *Haemophilus parasuis* , and *Streptococcus suis* .
(iii)*Limitations* . Animals intended for human consumption must not be slaughtered within 5 days of receiving a single-injection dose. PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 3. The authority citation for 21 CFR part 556 continues to read as follows: Authority: 21 U.S.C. 342, 360b, 371. § 556.228 [Redesignated as § 556.226] 4. Redesignate § 556.228 as § 556.226 and revise newly redesignated § 556.226 to read as follows: § 556.226 Enrofloxacin.
(a)*Acceptable daily intake (ADI)* . The ADI for total residues of enrofloxacin is 3 micrograms per kilogram of body weight per day.
(b)*Tolerances* . The tolerances for enrofloxacin are:
(1)*Cattle* —(i) *Liver (target tissue)* . 0.1 part per million
(ppm)desethylene ciprofloxacin (the marker residue).
(ii)[Reserved]
(2)*Swine* —(i) *Liver (target tissue)* . 0.5 ppm enrofloxacin (the marker residue).
(ii)[Reserved]
(c)*Related conditions of use* . See § 522.812 of this chapter. Dated: April 11, 2008. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. E8-8713 Filed 4-22-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 946 [VA-124-FOR; Docket ID OSM-2007-0013] Virginia Regulatory Program AGENCY: Office of Surface Mining Reclamation and Enforcement (OSM), Interior. ACTION: Final rule; Approval of amendment. SUMMARY: We are approving an amendment to the Virginia regulatory program under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). The revisions concern Virginia's standards for revegetation success for certain postmining land uses, distribution of topsoil and subsoil materials, and allow approval of natural stream restoration channel design, as developed in consultation with the Army Corps of Engineers. The amendment is intended to render the State's regulations no less effective than the Secretary's regulations in meeting the requirements of the Act. DATES: *Effective Date:* April 23, 2008. FOR FURTHER INFORMATION CONTACT: Mr. Earl Bandy, Director, Knoxville Field Office; Telephone:
(865)545-4103 ext. 186. E-mail: *ebandy@osmre.gov* . SUPPLEMENTARY INFORMATION: I. Background on the Virginia Program II. Submission of the Amendment III. OSM's Findings IV. Summary and Disposition of Comments V. OSM's Decision VI. Procedural Determinations I. Background on the Virginia Program Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its program includes, among other things, “* * * a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of the Act * * *; and rules and regulations consistent with regulations issued by the Secretary pursuant to the Act.” See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Virginia program on December 15, 1981. You can find background information on the Virginia program, including the Secretary's findings, the disposition of comments, and conditions of approval of the Virginia program in the December 15, 1981, **Federal Register** (46 FR 61088). You can also find later actions concerning Virginia's program and program amendments at 30 CFR 946.12, 946.13, and 946.15. II. Submission of the Amendment By letter dated February 13, 2007 (Administrative Record Number VA-1059), the Virginia Department of Mines, Minerals and Energy
(DMME)submitted an amendment to the Virginia program. In its submission, DMME proposed to revise the Virginia program regarding revegetation success standards for postmining land uses, distribution of topsoil and subsoil materials, and to allow approval of natural stream restoration channel design as developed in consultation with the Army Corp of Engineers. We announced receipt of the proposed amendment in the April 9, 2007, **Federal Register** (72 FR 17452). The public comment period closed on May 9, 2007. The portion of the February 13, 2007, amendment dealing with revegetation success standards involved proposed changes to Virginia's regulations at 4 VAC 25-130-816 and 817.116(a)(2) and (b)(3)(v)(C). DMME proposed to revise subsection (a)(2) to consider the levels of ground cover, production, or stocking as being equal to the approved success standard when they were not less than 70% of that success standard. DMME also proposed to revise subsection (a)(2) by adding an exception to the success standard requirements as provided for in subsection (b). Subsection
(b)provides success standards for certain approved postmining land uses. Finally, DMME proposed to amend subsection (a)(2) by deleting a provision requiring that the sampling techniques for measuring success use a 90% statistical confidence interval (i.e., one-sided test with a 0.10 alpha error). In subsection (b)(3)(v)(C), DMME proposed to amend standards for herbaceous vegetation success on postmining land uses where woody plants are used for wildlife management, recreation, shelter belts or forest uses other than commercial forest land by requiring that areas planted with a mixture of herbaceous and woody species sustain a herbaceous ground cover of 70%. After the February 13, 2007, proposed rule was published in the **Federal Register** , DMME revised the portion of its proposed amendment dealing with revegetation success standards. By electronic mail dated April 18, 2007, (Administrative Record No. VA-1074), DMME stated that it wished to withdraw the changes it previously made to 4 VAC 25-130-816 and 817.116(a)(2) regarding the sampling techniques and retain the original language. Additionally, DMME indicated that it wished to revise the herbaceous ground cover success standard of 4 VAC 25-130-816 and 817.117(b)(3)(v)(C) to require that postmining land uses of wildlife management, recreation, shelter belts, or forest uses other than commercial forest land that are planted with a mixture of herbaceous and woody species must sustain a herbaceous ground cover of 80%. We announced these proposed revisions in a July 5, 2007, **Federal Register** notice (72 FR 36632) in which we reopened the public comment period. The reopened public comment period closed July 20, 2007. After our review of the second resubmission of the amendments and based on our discussions regarding the amendment with DMME, DMME chose to resubmit 4 VAC 25-130-816 and 817.116(b)(3) and 816 and 817.116(b)(3)(v)(C) with added language that would facilitate the growth of woody plants in areas to be developed for fish and wildlife habitat, recreation, shelter belts, or forestry. By electronic mail dated August 30, 2007 (Administrative Record No. VA-1082), DMME stated that it would revise parts of 4 VAC 25-130-816.116 and 817.116 based, in part, on discussions with us regarding the benefits of using the Forestry Reclamation Approach (FRA). The FRA is a method for reclaiming coal-mined land to forests and is based on knowledge gained from both scientific research and experience. It is designed to restore forest land capability and accelerate the natural process of forest development. The FRA advocates selection of a suitable rooting medium for tree growth, loosely grading the growth medium to reduce compaction, using ground covers compatible with growing trees, planting early succession and commercially valuable tree species, and using proper tree planting techniques. We announced these proposed revisions in the December 17, 2007 (Administrative Record No. VA-1084) **Federal Register** notice (72 FR 71295) in which we reopened the public comment period. The public comment period closed January 2, 2008. No public hearing was held because one was not requested. III. OSM's Findings Following are the findings that we made concerning the amendment under SMCRA and 30 CFR 732.15 and 732.17. We are approving the amendment. 1. *4 VAC 25-130-816.22 and 817.22 Topsoil and subsoil* . Subpart (d)(1) is amended by inserting the words “and substitutes” between the word “materials” and the word “removed.” Also, the phrase “and (b)” is added immediately after the phrase “under Paragraph (a).” The word “Paragraph” is pluralized. Subpart (d)(1)(i) is amended by adding the word “when” between the word “thickness” and the word “consistent.” Also, the following sentence is added at the end of subpart (d)(1)(i): “Soil thickness may also be varied to the extent such variations help meet the specific revegetation goals identified in the permit.” Currently subsection
(d)provides as follows:
(d)Redistribution.
(1)Topsoil materials removed under Paragraph
(a)of this section shall be redistributed in a manner that—
(i)Achieves an approximately uniform, stable thickness consistent with the approved postmining land use, contours, and surface-water drainage systems;
(ii)Prevents excess compaction of the materials; and
(iii)Protects the materials from wind and water erosion before and after seeding and planting. As amended, 4 VAC 25-130-816.22(d) and 817.22(d) provide as follows:
(d)Redistribution.
(1)Topsoil materials and substitutes removed under Paragraphs
(a)and
(b)of this section shall be redistributed in a manner that—
(i)Achieves an approximately uniform, stable thickness when consistent with the approved postmining land use, contours, and surface-water drainage systems. Soil thickness may also be varied to the extent such variations help meet the specific revegetation goals identified in the permit;
(ii)Prevents excess compaction of the materials; and
(iii)Protects the materials from wind and water erosion before and after seeding and planting. We find that as amended, 4 VAC 25-130-816.22 and 817.22 are substantively identical to and no less effective than the Federal regulations concerning topsoil and subsoil at 30 CFR 816.22 and 817.22 and are therefore approved. 2. *4 VAC 25-130-816.43 and 817.43 Diversions.* Subpart (a)(4) is amended by deleting the second sentence and by revising the first sentence. In the first sentence, all the words following the phrase “continuously or frequently shall be” are deleted and are replaced by the words “designed by a qualified registered professional engineer and constructed to ensure stability and compliance with the standards of this Part and any other criteria set by the Division.” Subpart (a)(5) is deleted in its entirety. Currently, subparts (a)(4) and (a)(5) provide as follow:
(a)General requirements.
(4)Diversions which convey water continuously or frequently shall be lined with rock rip rap to at least the normal flow depth, including an allowance for freeboard. Diversions constructed in competent bedrock and portions of channels above normal flow depth shall comply with the velocity limitations of Paragraph
(5)below.
(5)The maximum permissible velocity for the following methods of stabilization are: Vegetated channel constructed in soil: 3.5 feet per second Vegetated channel with jute netting: 5.0 feet per second Rock rip rap lined channel: 16.0 feet per second Channel constructed in competent bedrock: No limit As amended, 4 VAC 25-130-816.43(a)(4) and 817.43(a)(4) provide as follows:
(4)Diversions which convey water continuously or frequently shall be designed by a qualified registered professional engineer and constructed to ensure stability and compliance with the standards of this Part and any other criteria set by the Division. In its submittal letter, the DMME stated that these changes to the Virginia rules will allow the approval of natural stream restoration channel design approved by the U.S. Army Corps of Engineers. While these amendments have no direct federal counterparts, they are consistent with the federal regulations at 30 CFR 816.43(a)(4) and 817.43(a)(4), both of which allow the regulatory authority to specify additional design criteria for diversions to meet the requirements of 30 CFR 816.43 and 817.43. Therefore, the amendments are approved. 3. *4 VAC 25-130-816.116(b)(3) and 817.116(b)(3). Revegetation; standards for success* . Subsection
(b)of each of these sections, concerning standards for success, is amended by revising subpart (b)(3). Currently, subpart (b)(3) provides as follows:
(b)Standards for success shall be applied in accordance with the approved postmining land use and, at a minimum, the following conditions:
(3)For areas to be developed for fish and wildlife habitat, recreation, shelter belts, or forest products, success of vegetation shall be determined on the basis of tree and shrub stocking and vegetative ground cover. Such parameters are described as follows: The DMME is amending these sections to indicate that for areas to be developed for fish and wildlife habitat, recreation, shelter belts, or forest products, woody plants must be stocked at least equal to the rates specified in the approved reclamation plan. Additionally, the DMME is adding a requirement that in order to minimize competition with woody plants, herbaceous ground cover should be limited to that necessary to control erosion and support the postmining land use. Seed mixtures and seeding rates will be specified in the approved reclamation plan. As amended, 4 VAC 25-130-816 and 817.116(b)(3) provide as follows: 4 VAC 25-130-816.116(b)(3) and 817.116(b)(3). Revegetation; standards for success.
(3)For areas to be developed for fish and wildlife habitat, recreation, shelter belts, or forestry, the stocking of woody plants must be at least equal to the rates specified in the approved reclamation plan. To minimize competition with woody plants, herbaceous ground cover should be limited to that necessary to control erosion and support the postmining land use. Seed mixtures and seeding rates will be specified in the approved reclamation plan. Such parameters are described as follows: While these amendments have no direct federal counterparts, they are consistent with the federal regulations at 30 CFR 816.116(b)(3) and 817.116(b)(3), both of which govern revegetation success for areas to be developed for fish and wildlife habitat, recreation, undeveloped land or forest products. Therefore, we are approving the amendments. It should be noted that these amendments mirror the changes recently promulgated by OSM to the counterpart revegetation success standards in the Tennessee federal program, at 30 CFR 942.816(b)(3) and 942.817(b)(3). (72 FR 9637, March 2, 2007) 4. *4 VAC 25-130-816.116(b)(3)(v)(C) and 817.116(b)(3)(v)(C). Revegetation; standards for success* . Subsection (b), concerning standards for success, is amended by revising subparts (b)(3)(v)(C). Currently, subsection (b)(3)(v)(C) provides as follows:
(v)Where woody plants are used for wildlife management, recreation, shelter belts, or forest uses other than commercial forest land:
(C)Areas planted with a mixture of herbaceous and woody species shall sustain an herbaceous vegetative ground cover of 90% and an average of 400 woody plants per acre. At least 40 of the woody plants for each acre shall be wildlife food-producing shrubs located suitably for wildlife enhancement, which may be distributed or clustered on the area. The DMME is amending this section by deleting the 90% herbaceous ground cover requirement, and by adding a phrase requiring herbaceous ground cover to comply with guidelines provided by the division and with the approved forestry reclamation plan. As amended, 4 VAC 25-130-816 and 817.116(b)(3)(v)(C) provide as follows: 4 VAC 25-130-816.116(b)(3)(v)(C) and 817.116(b)(3)(v)(C). Revegetation; standards for success.
(v)Where woody plants are used for wildlife management, recreation, shelter belts, or forest uses other than commercial forest land:
(C)Areas planted with a mixture of herbaceous and woody species shall sustain an herbaceous vegetative ground cover in accordance with guidance provided by the division and the approved forestry reclamation plan and establish an average of 400 woody plants per acre. At least 40 of the woody plants for each acre shall be wildlife food-producing shrubs located suitably for wildlife enhancement, which may be distributed or clustered on the area. While these amendments have no direct federal counterparts, they are consistent with the Federal regulations at 30 CFR 816.116(b)(3) and 817.116(b)(3), which govern revegetation success on areas to be developed for fish and wildlife habitat, recreation, undeveloped land or forest products. Therefore, we are approving the amendments. IV. Summary and Disposition of Comments Public Comments We asked for public comments on the amendment (Administrative Record No. VA-1084) and received comments from one person. The commenter was opposed to the addition “and substitutes” in subpart (d)(1) without any clarification. The commenter's concern was that the word “substitute” could be construed to mean whatever the operator wanted it to mean. However, the Virginia regulation cited below clearly limits the use of substitutes, thereby preventing the unfettered operator discretion feared by the commenter. This limitation is substantively identical to its federal counterparts at 30 CFR 816.22(b) and 817.22(b). The Virginia regulations at 4 VAC 25-130-816.22/817.22(b) state as follows: *Substitutes and supplements.* Selected overburden materials may be substituted for, or used as a supplement to topsoil if the operator demonstrates to the division, in accordance with 4 VAC 25-130-780.18 [or 784.13] that the resulting soil medium is equal to, or more suitable for sustaining vegetation than, the existing topsoil, and the resulting soil medium is the best available in the permit area to support revegetation. The commenter also urged suspension of consideration of these amendments until Virginia submits an adequate definition of the term “substitutes”. In response, we disagree that a definition is needed. The language of limitation above is sufficient to prevent the unrestricted use of substitutes. Also, we note that the Federal regulations likewise contain no definition of this term. Federal Agency Comments Under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, on February 22, 2007, we requested comments on the amendments from various Federal agencies with an actual or potential interest in the Virginia program (Administrative Record No. VA-1060). The United States Department of Labor, Mine Safety and Health Administration responded and stated that such amendments are deemed appropriate and there appears to be no conflict with MSHA regulations (Administrative Record No. VA-1061). The United States Department of the Interior, Bureau of Land Management responded and stated that they found no inconsistencies between the proposed changes and the Federal Laws, which govern mining (Administrative Record No. VA-1062). The United States Department of the Interior, Fish and Wildlife Service, Ecological Services responded and stated that it appears that no impacts to federally listed or proposed species or federally designated critical habitat will occur (Administrative Record No. VA-1066). Environmental Protection Agency
(EPA)Concurrence and Comments Under 30 CFR 732.17(h)(11)(ii), we are required to get a written concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 *et seq.* ) or the Clean Air Act (42 U.S.C. 7401 *et seq.* ). None of the revisions that Virginia proposed to make in this amendment pertain to air or water quality standards. Therefore, we did not ask EPA to concur on the amendment. V. OSM's Decision Based on the above findings, we are approving the amendment sent to us by Virginia on February 13, 2007. To implement this decision, we are amending the Federal regulations at 30 CFR part 946, which codify decisions concerning the Virginia program. We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Section 503(a) of SMCRA requires that the State's program demonstrate that the State has the capability of carrying out the provisions of the Act and meeting its purposes. Making this regulation effective immediately will expedite that process. SMCRA requires consistency of State and Federal standards. VI. Procedural Determinations Executive Order 12630—Takings The provisions in the rule based on counterpart Federal regulations do not have takings implications. This determination is based on the analysis performed for the Federal Regulations. Executive Order 12866—Regulatory Planning and Review This rule is exempt from review by the Office of Management and Budget under Executive Order 12866. Executive Order 12988—Civil Justice Reform The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that this rule meets the applicable standards of subsections
(a)and
(b)of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments because each program is drafted and promulgated by a specific State, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and the Federal regulations at 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR parts 730, 731, and 732 have been met. Executive Order 13132—Federalism This rule does not have Federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA. Executive Order 13175—Consultation and Coordination With Indian Tribal Governments In accordance with Executive Order 13175, we have evaluated the potential effects of this rule on Federally recognized Indian tribes and have determined that the rule does not have substantial direct effects 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. The basis for this determination is that our decision is on a State regulatory program and does not involve Federal regulations involving Indian lands. Executive Order 13211—Regulations That Significantly Affect the Supply, Distribution, or Use of Energy On May 18, 2001, the President issued Executive Order 13211 which requires agencies to prepare a Statement of Energy Effects for a rule that is
(1)considered significant under Executive Order 12866, and
(2)likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required. National Environmental Policy Act This rule does not require an environmental impact statement because section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that agency decisions on proposed State regulatory program provisions do not constitute major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)). Paperwork Reduction Act This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3507 *et seq.* ). Regulatory Flexibility Act The Department of the Interior certifies that the provisions in this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ) because they are based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the Federal regulations. Small Business Regulatory Enforcement Fairness Act This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:
(a)Does not have an annual effect on the economy of $100 million;
(b)Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and
(c)Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This determination is based upon the fact that the State provisions are based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule. Unfunded Mandates This rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that the State submittal, which is the subject of this rule, is based upon Federal regulations for which an analysis was prepared and a determination made that the Federal regulation did not impose an unfunded mandate. List of Subjects in 30 CFR Part 946 Intergovernmental relations, Surface mining, Underground mining. Dated: April 1, 2008. Thomas D. Shope, Regional Director, Appalachian Region. For the reasons set out in the preamble, 30 CFR part 946 is amended as set forth below: PART 946—VIRGINIA 1. The authority citation for part 946 continues to read as follows: Authority: 30 U.S.C. 1201 *et seq.* 2. Section 946.15 is amended in the table by adding a new entry in chronological order by “Date of final publication” to read as follows: § 946.15 Approval of Virginia regulatory program amendments. Original amendment submission date Date of final publication Citation/description * * * * * * * February 13, 2007 April 23, 2008 4 VAC 25-130-816.22(d)(1) and 817.22(d)(1). 4 VAC 25-130-816.43(a) and 817.43(a). 4 VAC 25-130-816.116(b) and 817.116(b). [FR Doc. E8-8838 Filed 4-22-08; 8:45 am] BILLING CODE 4310-05-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG-2008-0210] Special Local Regulation; Opening Day on San Francisco Bay, Pacific Inter-Club Yacht Association, San Francisco, CA AGENCY: Coast Guard, DHS. ACTION: Notice of enforcement of regulation. SUMMARY: The Coast Guard will enforce the Opening Day on San Francisco Bay special local regulation from 11:59 a.m. to 2 p.m. on April 27, 2008. This action is necessary to control vessel traffic and to ensure the safety of event participants and spectators. During the enforcement period, no spectator or vessel shall anchor, block, loiter, nor impede the through transit of participants or official patrol vessels, in the regulated areas during all applicable dates and times, unless cleared to do so by or through an official patrol vessel. DATES: The regulations in 33 CFR 100.1103 will be enforced from 11:59 a.m. to 2 p.m. on April 27, 2008. FOR FURTHER INFORMATION CONTACT: Lieutenant Junior Grade Sheral Richardson, Waterways Management Branch, U.S. Coast Guard Sector San Francisco, at
(415)399-7436. SUPPLEMENTARY INFORMATION: Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for giving notice of the enforcement date less than 30 days before the enforcement period goes into effect. Delaying notice of the enforcement date would be contrary to the public interest, since immediate action is needed to ensure the safety of the event participants, support vessels, spectator craft and other vessels transiting the event area. However advance notification of this recurring event is being given to users of San Francisco Bay via broadcast notice to mariners and yacht club newsletters. The Coast Guard will enforce the special local regulation for the annual Opening Day on the Bay in 33 CFR 100.1103 on April 29, 2008, from 11:59 a.m. to 2 p.m. The special local regulation includes San Francisco waterfront from Crissy Field to Pier 35, and can be defined by a line drawn from Fort Point (37[deg]48.66N, 122[deg]28.64W); thence easterly approximately 5,000 yards to a point located at 37[deg]49.15N, 122[deg]25.61W; thence easterly to the Blossom Rock Bell Buoy (37[deg]49.10N, 122[deg]24.20W); thence westerly to the Northeast corner of Pier 35; thence returning along the shoreline to the point of origin. Under the provisions of 33 CFR 100.1103, spectator vessels may not anchor, block, loiter, nor impede the through transit of participants or official patrol vessels within the area described during the event without permission from the Coast Guard Patrol Commander. Vessels entering the regulated area shall follow the parade route established by the sponsor and be capable of maintaining an approximate speed of six knots. The parade will be interrupted, as necessary, to permit the passage of commercial vessel traffic, which must cross the parade route at a no-wake speed and perpendicular to the parade route. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation. This notice is issued under authority of 33 CFR 100.1103 and 5 U.S.C. 552(a). Even though this notice is published in the **Federal Register** , if the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice, he or she may use a Broadcast Notice to Mariners to grant general permission to enter the regulated area. Dated: April 4, 2008. P.M. Gugg, Captain, U.S. Coast Guard, Captain of the Port, Sector San Francisco. [FR Doc. E8-8736 Filed 4-22-08; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG 2008-0200] Special Local Regulation; Blessing of the Fleet, Corinthian Yacht Club, San Francisco Bay, CA AGENCY: Coast Guard, DHS. ACTION: Notice of enforcement of regulation. SUMMARY: The Coast Guard will enforce the Blessing of the Fleet special local regulation from 8 a.m. to 11:59 a.m. on April 27, 2008. This action is necessary to control vessel traffic and to ensure the safety of event participants and spectators. During the enforcement period, no spectator shall anchor, block, loiter, nor impede the through transit of participants or official patrol vessels, in the regulated areas during all applicable effective dates and times, unless cleared to do so by or through an official patrol vessel. DATES: The regulations in 33 CFR 100.1103 will be enforced from 8 a.m. to 11:59 a.m. on April 27, 2008. FOR FURTHER INFORMATION CONTACT: Lieutenant Junior Grade Sheral Richardson, Waterways Management Branch, U.S. Coast Guard Sector San Francisco, at
(415)399-7436. SUPPLEMENTARY INFORMATION: Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for giving notice of the enforcement date less than 30 days before the enforcement period goes into effect. Delaying notice of the enforcement date would be contrary to the public interest, since immediate action is needed to ensure the safety of the event participants, support vessels, spectator craft and other vessels transiting the event area. However advance notification of this recurring event is being given to users of San Francisco Bay via broadcast notice to mariners and yacht club newsletters. The Coast Guard will enforce the special local regulation for the annual Blessing of the Fleet in 33 CFR 100.1103 on April 29, 2008, from 8 a.m. to 11:59 a.m. The special local regulation includes Raccoon Straits and can be defined by a line drawn from Bluff Point the southeastern side of Tiburon Peninsula to Point Campbell on the northern edge of Angel Island, and a line drawn from Peninsula Point on the southern edge of Tiburon Peninsula to Point Stuart on the western edge of Angel Island. Under the provisions of 33 CFR 100.1103, no spectator shall anchor, block, loiter, nor impede the through transit of participants or official patrol vessels, in the regulated areas during all applicable effective dates and times, unless cleared to do so by or through an official patrol vessel. Additionally, when hailed and/or signaled by an official patrol vessel, any spectator located within a regulated area during all applicable effective dates and times shall come to an immediate stop. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this special local regulation. This notice is issued under authority of 33 CFR 100.1103 and 5 U.S.C. 552(a). Even though this event is published in the **Federal Register** , if the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice, he or she may use a Broadcast Notice to Mariners to grant general permission to enter the regulated area. Dated: April 4, 2008. P.M. Gugg, Captain, U.S. Coast Guard, Captain of the Port, Sector San Francisco. [FR Doc. E8-8733 Filed 4-22-08; 8:45 am] BILLING CODE 4910-15-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 63 [EPA-HQ-OAR-2003-0138, FRL-8557-1] RIN 2060-AO99 National Emission Standards for Hazardous Air Pollutants: Organic Liquids Distribution (Non-Gasoline) AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: EPA is taking direct final action on the national emission standards for hazardous air pollutants for organic liquids distribution (non-gasoline), which EPA promulgated on February 3, 2004, and amended on July 28, 2006. In this action, EPA is clarifying combustion control device compliance requirements, certain storage tank control compliance dates, and vapor balance system monitoring requirements. In addition, EPA is correcting typographical errors found in the July 28, 2006, final rule amendments. DATES: This direct final rule is effective on July 22, 2008, without further notice, unless EPA receives adverse comment by June 9, 2008. If we receive adverse comment, we will publish a timely withdrawal in the **Federal Register** informing the public that this rule, or the relevant section of this rule, will not take effect. *Public Hearing:* If anyone contacts EPA requesting to speak at a public hearing concerning this rulemaking by May 5, 2008, we will hold a public hearing on May 8, 2008. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2003-0138, by one of the following methods: • *http://www.regulations.gov.* Follow the on-line instructions for submitting comments. • *E-mail: a-and-r-Docket@epa.gov.* • *Fax:*
(202)566-9744. • *Mail:* Air and Radiation Docket, Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Please include a total of two copies. • *Hand Delivery:* In person or by courier, deliver your comments to: Air and Radiation Docket, Public Reading Room, EPA West Building, Room 3334, 1301 Constitution Ave., NW., Washington, DC 20004. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. Please include a total of two copies. We request that a separate copy also be sent to the contact persons listed below (see FOR FURTHER INFORMATION CONTACT ). *Instructions:* Direct your comments to Docket ID No. EPA-HQ-OAR-2003-0138. 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 information about EPA's public docket, visit the EPA Docket Center homepage at *http://www.epa.gov/epahome/dockets.htm.* *Docket:* All documents in the docket are listed either in the *http://www.regulations.gov* index or in the legacy docket, Docket No. A-98-13. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *http://www.regulations.gov* or in hard copy at the Air and Radiation Docket, EPA West Building, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is
(202)566-1744, and the telephone number for the Air and Radiation Docket is
(202)566-1742. *Public Hearing:* If you are interested in attending the public hearing, contact Ms. Janet Eck at
(919)541-7946 to verify that a hearing will be held. If a public hearing is held, it will be held at 10 a.m. at EPA's Campus located at 109 T.W. Alexander Drive in Research Triangle Park, NC, or an alternate site nearby. If no one contacts EPA requesting to speak at a public hearing concerning this rule by May 5, 2008 this hearing will be cancelled without further notice. For Further Information Contact: *General and Technical Information:* Mr. Stephen Shedd, Office of Air Quality Planning and Standards, Sector Policies and Programs Division, Coatings and Chemicals Group (E143-01), EPA, Research Triangle Park, NC 27711, telephone:
(919)541-5397, facsimile number:
(919)685-3195, e-mail address: *shedd.steve@epa.gov.* *Compliance Information:* Ms. Marcia Mia, Office of Compliance, Air Compliance Branch (2223A), EPA, Ariel Rios Building, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, telephone:
(202)564-7042, facsimile number:
(202)564-0050, e-mail address: *mia.marcia@epa.gov.* SUPPLEMENTARY INFORMATION: EPA is publishing this rule without prior proposal because we view this as a noncontroversial action and anticipate no adverse comment because the changes being implemented clarify the application of the rule, make the rule consistent with other regulations with no loss in its effectiveness in achieving emission reductions, and correct typographical and format errors. However, in the Proposed Rules section of this **Federal Register** , we are publishing a separate document that will serve as the proposed rule for these revisions if adverse comments are received on this direct final rule. If we receive adverse comment on a distinct section of this rule, we will publish a timely withdrawal in the **Federal Register** informing the public that some or all of the amendments in this rule will not take effect. The provisions that are not withdrawn will become effective on the date set out above, notwithstanding adverse comment on any other provision, unless we determine that it would not be appropriate to promulgate those provisions due to their being affected by the provisions for which we receive any adverse comments. We will address all public comments in a subsequent final rule based on the proposed rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information about commenting on this rule, see the ADDRESSES section of this document. *Submitting CBI.* Do not submit this information to EPA through *http://www.regulations.gov* or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information on a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. Categories and entities potentially regulated by this action include: Category NAICS* code Examples of regulated entities Industry 325211, 325192, 325188, 32411, 49311, 49319, 48611, 42269, 42271 Operations at major sources that transfer organic liquids into or out of the plant site, including: liquid storage terminals, crude oil pipeline stations, petroleum refineries, chemical manufacturing facilities, and other manufacturing facilities with collocated OLD operations. Federal Government Federal agency facilities that operate any of the types of entities listed under the “industry” category in this table. *North American Industry Classification System/Considered to be the primary industrial codes for the plant sites with OLD operations. This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this final rule. To determine whether your facility is regulated by this action, you should examine the applicability criteria in 40 CFR part 63, subpart EEEE. If you have any questions regarding the applicability of this final rule to a particular entity, consult either the air permit authority for the entity or your EPA regional representative as listed in 40 CFR 63.13. *Worldwide Web (WWW).* In addition to being available in the docket, an electronic copy of this final rule is also available on the WWW through the Technology Transfer Network (TTN). Following signature, a copy of this final rule will be posted on the TTN's policy and guidance page for newly proposed or promulgated rules at the following address: * http://www.epa.gov/ttn/oarpg.* The TTN provides information and technology exchange in various areas of air pollution control. *Outline:* The information presented in this preamble is organized as follows: I. Background II. Summary of These Final Rule Amendments III. Rationale for These Final Rule Amendments A. Use of TOC as a Surrogate for HAP When Demonstrating Compliance with Percent Emission Reduction B. Compliance Date and Initial Demonstration of Compliance for Storage Tanks Using Vapor Balancing or Routing Emissions Back to a Process or a Fuel Gas System C. Monitoring of Vapor Balancing System Components With the Potential To Leak D. Format, Grammatical, and Typographical Errors IV. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer and Advancement Act J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations K. Congressional Review Act I. Background On February 3, 2004 (69 FR 5063), EPA promulgated the National Emission Standards for Hazardous Air Pollutants: Organic Liquids Distribution (Non-Gasoline) (OLD NESHAP) (40 CFR part 63, subpart EEEE) pursuant to section 112 of the Clean Air Act (CAA). In response to several petitions for administrative reconsideration of the OLD NESHAP and several petitions for judicial review filed with the United States Court of Appeals for the District of Columbia Circuit, and pursuant to a settlement agreement between some of the parties to the litigation, EPA proposed amendments to subpart EEEE on November 14, 2005 (70 CFR 69210). EPA received comments from four entities. On July 28, 2006 (71 FR 42898), EPA promulgated amendments to subpart EEEE based on consideration of the comments received on the proposed amendments. II. Summary of These Final Rule Amendments Under these final rule amendments, the following changes or clarifications are being promulgated. • Removing the requirement that owners and operators must obtain prior approval from the Administrator to use total organic compounds
(TOC)as a surrogate for hazardous air pollutants
(HAP)when demonstrating compliance with the percent emission reduction requirements for combustion devices. • Clarifying that demonstration of initial compliance for storage tanks that elect to comply with either the vapor balancing work practice requirement or the routing of emissions to a fuel gas system or back to a process work practice requirement must be made by April 25, 2011, and not 10 years after February 3, 2004. We retain the requirement that compliance must occur prior to the specified date or the first degassing, whichever occur earlier. • Clarifying that the continuous compliance requirements for the monitoring of a transfer rack system using vapor balancing is for all points in the system that may leak and that monitoring is not required in any quarter in which loading does not occur. These final rule amendments also correct several format, grammatical, and typographical errors which occur in Table 2 (item 9.b.ii), Table 5 (item 1.b), Table 6 (item 1), Table 7 (item 1.a.i, item 1.c.i, and item 2.a.i), and § 63.2343(d). III. Rationale for These Final Rule Amendments A. Use of TOC as a Surrogate for HAP When Demonstrating Compliance With Percent Emission Reduction Section 63.2354(b) of the NESHAP specifies that you must comply with various requirements of 40 CFR part 63, subpart SS for performance testing provisions, including § 63.997(e). Additionally, § 63.2346(f) specifies that if you elect to demonstrate compliance with the percent reduction requirements using TOC rather than organic HAP, you must first demonstrate, subject to approval of the Administrator, that TOC is an appropriate surrogate for organic HAP. This requirement was intended to address circumstances under which a device such as a condenser could achieve substantively different results from one compound to another. Under these conditions, an inlet and outlet percent control determination for TOC might not be equivalent to a similar determination for each or total HAP. Since promulgation, we have received questions on whether the requirement to first demonstrate that TOC is an appropriate surrogate for organic HAP is necessary for a combustion device. When organic compounds are controlled by combustion processes, the organic compounds emitted at the outlet of the device are not the same as those entering the inlet to the device and are typically unknown. Further, unlike non-combustion devices, combustion devices achieve a greater uniformity of destruction across all organic HAP compounds. Therefore, we have determined that the requirement to first demonstrate that TOC is an appropriate surrogate for organic HAP is unwarranted for combustion devices and have modified paragraph
(f)of 40 CFR 63.2346 to make this requirement applicable only to non-combustion devices. B. Compliance Date and Initial Demonstration of Compliance for Storage Tanks Using Vapor Balancing or Routing Emissions Back to a Process or a Fuel Gas System Section 63.2342 identifies when an owner or operator must comply with the requirements of subpart EEEEE, while § 63.2358 identifies the dates by which an owner or operator must demonstrate initial compliance. As discussed below, there is an inconsistency in these two sections of the rule as they apply to storage tanks for which vapor balancing or routing of emissions to a fuel gas system or back to a process are used to comply with the rule. Paragraph (b)(1) of § 63.2342 states that owners or operators of existing affected sources must be in compliance with the emission limitations, operating limits, and work practice standards for existing sources by February 5, 2007, except as specified in § 63.2342(b)(2). Paragraph (b)(2) states that “floating roof tanks at existing affected sources must be in compliance with the work practice standards in Table 4 to this subpart, item 1, at all times after the next degassing and cleaning activity or within 10 years after February 3, 2004, whichever occurs first. If the first degassing and cleaning activity occurs during the 3 years following February 3, 2004, the compliance date is February 5, 2007.” With regards to demonstrating initial compliance, paragraph (c)(1) of § 63.2358 states that “for storage tanks at existing affected sources complying with the work practice standard in Table 4 to this subpart, you must conduct your initial compliance demonstration the next time the storage tank is emptied and degassed, but not later than 10 years after February 3, 2004.” The work practice standards in Table 4 for storage tanks at existing facilities are: • Comply with the requirements of 40 CFR part 63, subpart WW (control level 2), which addressed the use of floating roofs; • Comply with the requirements of § 63.984 for routing emissions to a fuel gas system or back to a process; and • Comply with the requirements of § 63.2346(a)(4) for vapor balancing emissions to the transport vehicle from which the storage tank is filled. As stated in the July 28, 2006, **Federal Register** in response to a public comment (71 FR 42899), the technical basis for allowing demonstration of initial compliance up to 10 years after February 3, 2004, applies only to storage tanks with floating roofs and not to storage tanks with fixed roofs. EPA, in both the February 3, 2004 rulemaking promulgating 40 CFR part 63, subpart EEEE, and in the July 28, 2006 rulemaking promulgating amendments to 40 CFR part 63, subpart EEEE, inadvertently failed to revise § 63.2358 to reflect its intent to apply the “up to 10 years” compliance provision to only the “floating roof” work practice standard. As the current regulation stands, owners and operators seeking to comply with the work practice standards for storage tanks would have “up to 10 years” to demonstrate initial compliance if they elect to comply by routing the emissions to a fuel gas system or back to a process or by using a vapor balancing system. This was never EPA's intent for these two types of work practice standards. EPA points out that these same types of work practice standards are allowed for transfer racks, and the rule is unambiguous that demonstration of initial compliance is required within 180 days after the compliance date of February 3, 2007. To correct this oversight, EPA is clarifying that the “up to 10-year” demonstration of initial compliance date applies only when a floating roof is used to comply with 40 CFR part 63, subpart EEEE, and inserting the actual date “February 3, 2014” into the rule text. In addition, the intended compliance date has past (180 days after the compliance date of February 3, 2007) to demonstrate initial compliance if they elect to route storage tank emissions to a fuel system or back to a process or to use vapor balancing. Because facilities will need time to plan and install equipment and affected sources had up to 3 years to comply with the original rule, we are specifying the compliance date for routing storage tank emissions to a fuel gas system or back to a process or to use vapor balancing to be 3 years from this notice. However, we retain and still require compliance by “the next time the storage tank is emptied and degassed, but not later than” 3 years from this notice. C. Monitoring of Vapor Balancing System Components With the Potential To Leak Table 10 to 40 CFR part 63, subpart EEEE addresses continuous compliance requirements, in part, for vapor balancing systems when used for transfer racks and storage tanks. EPA has received a question concerning the relationship between the continuous compliance requirements for vapor balancing systems and those for equipment leak components. For vapor balancing systems, there are two places in 40 CFR part 63, subpart EEEE that identify compliance requirements—Table 10 and § 63.2346(a)(4)(v). As found in item 4.b.i to Table 10, the continuous compliance requirement for a transfer rack using a vapor balancing system reads: “Monitoring each potential source of vapor leakage in the system quarterly during the loading of a transport vehicle or the filling of a container using the methods and procedures described in the rule requirements selected for the work practice standard for equipment leak components as specified in Table 4 to subpart EEEE, item 4. An instrument reading of 500 ppmv defines a leak. Repair of leaks is performed according to the repair requirements specified in your selected equipment leak standards.” Paragraph (a)(4)(v) of § 63.2346 identifies leak detection and repair
(LDAR)requirements for pressure relief devices used in vapor balancing systems. The current rule language is, at best, ambiguous as to the relationship of this paragraph and the language in Table 10. For equipment leak components, which are defined in 40 CFR part 63, subpart EEEE as pumps, valves, and sampling connections, the owner or operator selects one of three 40 CFR part 63 subparts, as specified in item 4 of Table 4. These three subparts identify LDAR provisions that are to be applied to pumps, valves, and sampling connections. To clarify the intended relationship between these various provisions, the phrase “each potential source of vapor leakage” is intended to apply to any and all equipment in the vapor balancing system that may leak, including, but not limited to pumps, valves, and sampling connections. For all such equipment, the owner or operator is to apply the applicable provisions found in the equipment leak standard selected by the owner or operator to comply with the equipment leak components. This could mean that an owner or operator may be applying LDAR requirements found in the selected 40 CFR part 63 subpart for components other than a pump, valve, or sampling connection. If the vapor balancing system has a pressure relief valve, however, the owner or operator would comply with the LDAR provisions for pressure relief valves found in § 63.2346(a)(4)(v). For equipment leak components (as defined in 40 CFR part 63, subpart EEEE) that are not part of a vapor balancing system, continuous compliance is demonstrated as specified in item 5 to Table 10. To clarify these relationships, EPA is revising item 4.b.i in Table 10 or 40 CFR part 63, subpart EEEE to read as follows: “Except for pressure relief devices, monitoring each potential source of vapor leakage in the system, including, but not limited to pumps, valves, and sampling connections, quarterly during the loading of a transport vehicle or the filling of a container using the methods and procedures described in the rule requirements selected for the work practice standard for equipment leak components as specified in Table 4 to this subpart, item 4. An instrument reading of 500 ppmv defines a leak. Repair of leaks is performed according to the repair requirements specified in your selected equipment leak standards. For pressure relief devices, comply with § 63.2346(a)(4)(v). If no loading of a transport vehicle or filling of a container occurs during a quarter, then monitoring of the vapor balancing system is not required.” Finally, item 6.b.i to Table 10 of 40 CFR part 63, subpart EEEE addresses the same vapor balancing system monitoring requirements, but for storage tanks. EPA is making the same changes as in item 4.b.i to Table 10. EPA is also making one additional change. As the rule currently reads, item 6.b.i refers to “monitoring each potential source of vapor leakage in the system quarterly during the loading of a transport vehicle or the filling of a container.” This item should be referring to the loading of a storage tank and not the loading of a transport vehicle or the filling or a container. Therefore, EPA is also correcting this incorrect reference. D. Format, Grammatical, and Typographical Errors 1. In Table 2, item 9.b.ii or 40 CFR part 63, subpart EEEE should have been placed on a separate line rather than on the same line as the end of item 9.b.i. For clarity, item 9.b.ii has been reformatted so that it starts on its own line. 2. In Table 5 of 40 CFR part 63, subpart EEEE, the first two columns associated with item b. were incorrectly placed under the headings “According to * * *” and “Using * * *”. They should have been placed under the headings, respectively, “You must conduct * * *” and “According to * * *”. 3. In Table 6, item 1 of 40 CFR part 63, subpart EEEE, the first column cross-references items 1 through 6 in Table 2. The sentence, therefore, should refer to “meeting *any* set of tank capacity and liquid organic HAP vapor pressure criteria” rather to “meeting *either* set.” 4. In Table 6 of 40 CFR part 63, subpart EEEE, the second column of item 1 states, in part, “or as an option for combustion devices to an exhaust concentration of ≤20 ppmv.” The word “nonflare” was inadvertently omitted from this sentence. This sentence is revised to read, in part, “or as an option for nonflare combustion devices to an exhaust concentration of ≤20 ppmv.” This makes the sentence consistent with the other items in Table 6. 5. In Table 7 of 40 CFR part 63, subpart EEEE, three typographical errors are being corrected from the July 28, 2006, FR notice. In item 1.a.i, “perform” was misspelled as “perofrm.”. In item 1.c.i, the cross-reference was incorrectly identified as § 3.2346(a)(4); the correct cross-reference is § 63.2346(a)(4). In item 2.a.i, “primary” was misspelled as “priamry.” 6. Section 63.2343(d) currently reads: “If one or more of the events identified in paragraphs (d)(1) through
(4)of this section occur since the filing of the Notification of Compliance Status or the last Compliance report, you must submit a subsequent Compliance report as specified in paragraphs (b)(3) and (c)(3) of this section.” The cross-references to paragraphs (b)(3) and (c)(3) are incorrect. The correct cross-references are paragraphs (b)(2) and (c)(2). The direct final rule makes this correction. IV. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under the Executive Order. B. Paperwork Reduction Act This action does not impose any new information collection burden. The final amendments clarify, but do not add requirements increasing the collection burden. However, the Office of Management and Budget
(OMB)has previously approved the information collection requirements contained in the existing regulations at 40 CFR part 63, subpart EEEE under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501, *et seq.,* and has assigned OMB control number 2060-0539. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9. C. Regulatory Flexibility Act The Regulatory Flexibility Act
(RFA)generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the Agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of today's final rule amendments on small entities, a small entity is defined as:
(1)A small business as defined by the Small Business Administration's
(SBA)regulations at 13 CFR 121.201;
(2)a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; or
(3)a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. The final rule amendments will not impose any new requirements on small entities, and, therefore, will have no significant adverse economic impact on subject small entities. The Administrator certifies that this action will not have a significant economic impact on a substantial number of small entities. D. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any 1 year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires us to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows us to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before we establish any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, we must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements. EPA has determined that these final rule amendments do not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any one year. These final rule amendments clarify certain provisions and correct typographical errors in the rule text for a rule EPA determined not to include a Federal mandate that may result in an estimated cost of $100 million or more (69 FR 5061, February 3, 2004). These clarifications do not change the level or cost of the standard, except, in some cases, reduce the cost of testing for combustion control devices at some facilities using that option. Thus, these final rule amendments are not subject to the requirements of section 202 and 205 of the UMRA. EPA has determined that these final rule amendments contain no regulatory requirements that might significantly or uniquely affect small governments. These final rule amendments clarify certain provisions and correct typographical errors in the rule text, thus, should not affect small governments. E. Executive Order 13132: Federalism Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” These final rule amendments do not have federalism implications. They will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. They provide clarification and correct typographical errors. These changes do not modify existing or create new responsibilities among EPA Regional Offices, States, or local enforcement agencies. Thus, Executive Order 13132 does not apply to these final rule amendments. F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” These final rule amendments do not have tribal implications, as specified in Executive Order 13175. They will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Thus, Executive Order 13175 does not apply to these final rule amendments. G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This action is not subject to Executive Order 13045 because it is based solely on technology performance. H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use These final rule amendments are not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because they are not a significant regulatory action under Executive Order 12866. I. National Technology Transfer and Advancement Act Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards
(VCS)in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. VCS are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by VCS bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable VCS. This action does not involve technical standards. Therefore, EPA did not consider the use of any VCS. J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations Executive Order 12898 (59 FR 7629, February 16, 1994) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. EPA has determined that these final rule amendments will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. These final rule amendments do not relax the control measures on sources regulated by the rule and, therefore, will not cause emissions increases from these sources. K. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801, *et seq.,* as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing the final rule amendments and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the United States prior to publication of the final rule amendments in the **Federal Register** . A major rule cannot take effect until 60 days after it is published in the **Federal Register** . This action is not a “major rule” as defined by 5 U.S.C. 804(2). These final rule amendments will be effective on July 22, 2008. List of Subjects in 40 CFR Part 63 Environmental protection, Administrative practice and procedure, Air pollution control, Hazardous substances, Intergovernmental relations, Reporting and recordkeeping requirements. Dated: April 16, 2008. Stephen L. Johnson, Administrator. For the reasons set out in the preamble, title 40, chapter I, part 63 of the Code of Federal Regulations is amended as follows: PART 63—[AMENDED] 1. The authority citation for part 63 continues to read as follows: Authority: 42 U.S.C. 7401, *et seq.* Subpart EEEE—[Amended] 2. Section 63.2343 is amended by revising paragraph
(d)introductory text to read as follows: § 63.2343 What are my requirements for emission sources not requiring control?
(d)If one or more of the events identified in paragraphs (d)(1) through
(4)of this section occur since the filing of the Notification of Compliance Status or the last Compliance report, you must submit a subsequent Compliance report as specified in paragraphs (b)(2) and (c)(2) of this section. 3. Section 63.2346 is amended by revising paragraph
(f)to read as follows: § 63.2346 What emission limitations, operating limits, and work practice standards must I meet?
(f)For noncombustion devices, if you elect to demonstrate compliance with a percent reduction requirement in Table 2 to this subpart using total organic compounds
(TOC)rather than organic HAP, you must first demonstrate, subject to the approval of the Administrator, that TOC is an appropriate surrogate for organic HAP in your case; that is, for your storage tank(s) and/or transfer rack(s), the percent destruction of organic HAP is equal to or higher than the percent destruction of TOC. This demonstration must be conducted prior to or during the initial compliance test. 4. Section 63.2358 is amended by revising paragraphs (b)(1) and (c)(1) to read as follows: § 63.2358 By what date must I conduct performance tests and other initial compliance demonstrations? (b)(1) For storage tanks and transfer racks at existing affected sources complying with the emission limitations listed in Table 2 to this subpart or with the work practice standards in items 1.b or 1.c in Table 4 to this subpart, you must demonstrate initial compliance with the emission limitations the next time the storage tank is emptied and degassed, but not later than April 25, 2011. (c)(1) For storage tanks at existing affected sources complying with the work practice standard in item 1.a in Table 4 to this subpart, you must conduct your initial compliance demonstration the next time the storage tank is emptied and degassed, but not later than February 3, 2014. 5. Table 2 to Subpart EEEE of Part 63 is amended by revising entry 9. to read as follows: Table 2 to Subpart EEEE of Part 63.—Emission Limits If you own or operate . . . And if . . . Then you must . . . * * * * * * * 9. A transfer rack at a new facility where the total actual annual facility-level organic liquid loading volume through transfer racks is less than 800,000 gallons a. The total Table 1 organic HAP content of the organic liquid being loaded through one or more of the transfer rack's arms is at least 25 percent by weight and is being loaded into a transport vehicle i. See the requirements in items 7.a.i and 7.a.ii of this table. b. One or more of the transfer rack's arms is filling a container with a capacity equal to or greater than 55 gallons i. For all such loading arms at the rack during the loading of organic liquids, comply with the provisions of §§ 63.924 through 63.927 of 40 CFR part 63, Subpart PP—National Emission Standards for Containers, Container Level 3 controls; OR ii. During the loading of organic liquids, comply with the work practice standards specified in item 3.a of Table 4 to this subpart. * * * * * * * 6. Table 5 to Subpart EEEE of Part 63 is amended by revising entry 1. to read as follows: Table 5 to Subpart EEEE of Part 63.—Requirements for Performance Tests and Design Evaluations For . . . You must conduct . . . According to . . . Using . . . To determine . . . According to the following requirements . . . 1. Each existing, each reconstructed, and each new affected source using a nonflare control device to comply with an emission limit in Table 2 to this subpart, items 1 through 10 a. A performance test to determine the organic HAP (or, upon approval, TOC) control efficiency of each nonflare control device, OR the exhaust concentration of each combustion device; OR i. § 63.985(b)(1)(ii), § 63.988(b), § 63.990(b), or § 63.995(b)
(1)EPA Method 1 or 1A in appendix A-1 of 40 CFR part 60, as appropriate
(A)Sampling port locations and the required number of traverse points
(i)Sampling sites must be located at the inlet and outlet of each control device if complying with the control efficiency requirement or at the outlet of the control device if complying with the exhaust concentration requirement; AND
(ii)the outlet sampling site must be located at each control device prior to any releases to the atmosphere.
(2)EPA Method 2, 2A, 2C, 2D, or 2F in appendix A-1 of 40 CFR part 60, or EPA Method 2G in appendix A-2 of 40 CFR part 60, as appropriate
(A)Stack gas velocity and volumetric flow rate See the requirements in items 1.a.i.(1)(A)(i) and
(ii)of this table.
(3)EPA Method 3 or 3B in appendix A-2 of 40 CFR part 60, as appropriate
(A)Concentration of CO 2 and O 2 and dry molecular weight of the stack gas See the requirements in items 1.a.i.(1)(A)(i) and
(ii)of this table.
(4)EPA Method 4 in appendix A-3 of 40 CFR part 60
(A)Moisture content of the stack gas See the requirements in items 1.a.i.(1)(A)(i) and
(ii)of this table.
(5)EPA Method 18 in appendix A-6 of 40 CFR part 60, or EPA Method 25 or 25A in appendix A-7 of 40 CFR part 60, as appropriate, or EPA Method 316 in appendix A of 40 CFR part 63 for measuring form-aldehyde
(A)Total organic HAP (or, upon approval, TOC), or formaldehyde emissions
(i)The organic HAP used for the calibration gas for EPA Method 25A in appendix A-7 of 40 CFR part 60 must be the single organic HAP representing the largest percent by volume of emissions; AND
(ii)During the performance test, you must establish the operating parameter limits within which total organic HAP (or, upon approval, TOC) emissions are reduced by the required weight-percent or, as an option for nonflare combustion devices, to 20 ppmv exhaust concentration. b. A design evaluation (for nonflare control devices) to determine the organic HAP (or, upon approval, TOC) control efficiency of each nonflare control device, or the exhaust concentration of each combustion control device § 63.985(b)(1)(i) During a design evaluation, you must establish the operating parameter limits within which total organic HAP, (or, upon approval, TOC) emissions are reduced by at least 95 weight-percent for storage tanks or 98 weight-percent for transfer racks, or, as an option for nonflare combustion devices, to 20 ppmv exhaust concentration * * * * * * * 7. Table 6 to Subpart EEEE of Part 63 is amended by revising entry 1. to read as follows: Table 6 to Subpart EEEE of Part 63.—Initial Compliance With Emission Limits For each . . . For the following emission limit . . . You have demonstrated initial compliance if . . . 1. Storage tank at an existing, reconstructed, or new affected source meeting any set of tank capacity and liquid organic HAP vapor pressure criteria specified in Table 2 to this subpart, items 1 through 6 Reduce total organic HAP (or, upon approval, TOC) emissions by at least 95 weight-percent, or as an option for nonflare combustion devices to an exhaust concentration of ≤20 ppmv Total organic HAP (or, upon approval, TOC) emissions, based on the results of the performance testing or design evaluation specified in Table 5 to this subpart, item 1.a or 1.b, respectively, are reduced by at least 95 weight-percent or as an option for nonflare combustion devices to an exhaust concentration ≤20 ppmv. * * * * * * * 8. Table 7 to Subpart EEEE of Part 63 is amended by revising entries 1. and 2. to read as follows: Table 7 to Subpart EEEE of Part 63.—Initial Compliance With Work Practice Standards For each . . . If you . . . You have demonstrated initial compliance if . . . 1. Storage tank at an existing affected source meeting either set of tank capacity and liquid organic HAP vapor pressure criteria specified in Table 2 to this subpart, items 1 or 2 a. Install a floating roof or equivalent control that meets the requirements in Table 4 to this subpart, item 1.a i. After emptying and degassing, you visually inspect each internal floating roof before the refilling of the storage tank and perform seal gap inspections of the primary and secondary rim seals of each external floating roof within 90 days after the refilling of the storage tank. b. Route emissions to a fuel gas system or back to a process i. You meet the requirements in § 63.984(b) and submit the statement of connection required by § 63.984(c). c. Install and, during the filling of the storage tank with organic liquids, operate a vapor balancing system i. You meet the requirements in § 63.2346(a)(4). 2. Storage tank at a reconstructed or new affected source meeting any set of tank capacity and liquid organic HAP vapor pressure criteria specified in Table 2 to this subpart, items 3 through 5 a. Install a floating roof or equivalent control that meets the requirements in Table 4 to this subpart, item 1.a i. You visually inspect each internal floating roof before the initial filling of the storage tank, and perform seal gap inspections of the primary and secondary rim seals of each external floating roof within 90 days after the initial filling of the storage tank. b. Route emissions to a fuel gas system or back to a process i. See item 1.b.i of this table. c. Install and, during the filling of the storage tank with organic liquids, operate a vapor balancing system i. See item 1.c.i of this table. * * * * * * * 9. Table 10 to Subpart EEEE of Part 63 is amended by revising entries 4. and 6. to read as follows: Table 10 to Subpart EEEE of Part 63.—Continuous Compliance With Work Practice Standards For each . . . For the following standard . . . You must demonstrate continuous compliance by . . . * * * * * * * 4. Transfer rack that is subject to control based on the criteria specified in Table 2 to this subpart, items 7 through 10, at an existing, reconstructed, or new affected source a. Ensure that organic liquids are loaded into transport vehicles in accordance with the requirements in Table 4 to this subpart, items 5 or 6, as applicable i. Ensuring that organic liquids are loaded into transport vehicles in accordance with the requirements in Table 4 to this subpart, items 5 or 6, as applicable. b. Install and, during the loading of organic liquids, operate a vapor balancing system i. Except for pressure relief devices, monitoring each potential source of vapor leakage in the system, including, but not limited to pumps, valves, and sampling connections, quarterly during the loading of a transport vehicle or the filling of a container using the methods and procedures described in the rule requirements selected for the work practice standard for equipment leak components as specified in Table 4 to this subpart, item 4. An instrument reading of 500 ppmv defines a leak. Repair of leaks is performed according to the repair requirements specified in your selected equipment leak standards. For pressure relief devices, comply with § 63.2346(a)(4)(v). If no loading of a transport vehicle or filling of a container occurs during a quarter, then monitoring of the vapor balancing system is not required. c. Route emissions to a fuel gas system or back to a process i. Continuing to meet the requirements specified in § 63.984(b). * * * * * * * 6. Storage tank at an existing, reconstructed, or new affected source meeting any of the tank capacity and vapor pressure criteria specified in Table 2 to this subpart, items 1 through 6 a. Route emissions to a fuel gas system or back to the process i. Continuing to meet the requirements specified in § 63.984(b). b. Install and, during the filling of the storage tank with organic liquids, operate a vapor balancing system i. Except for pressure relief devices, monitoring each potential source of vapor leakage in the system, including, but not limited to pumps, valves, and sampling connections, quarterly during the loading of a storage tank using the methods and procedures described in the rule requirements selected for the work practice standard for equipment leak components as specified in Table 4 to this subpart, item 4. An instrument reading of 500 ppmv defines a leak. Repair of leaks is performed according to the repair requirements specified in your selected equipment leak standards. For pressure relief devices, comply with § 63.2346(a)(4)(v). If no loading of a transport vehicle or filling of a container occurs during a quarter, then monitoring of the vapor balancing system is not required. [FR Doc. E8-8810 Filed 4-22-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0872; FRL-8360-4] Cyazofamid; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a tolerance for combined residues of cyazofamid and its metabloite CCIM in or on carrot, roots. Interregional Research Project Number 4 (IR-4) requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective April 23, 2008. Objections and requests for hearings must be received on or before June 23, 2008, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2007-0872. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305-5218; e-mail address: *stanton.susan@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2007-0872 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before June 23, 2008. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2007-0872, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. II. Petition for Tolerance In the **Federal Register** of September 28, 2007 (72 FR 55204) (FRL-8147-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 7E7244) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.601 be amended by establishing a tolerance for combined residues of the fungicide cyazofamid, 4-chloro-2-cyano- *N* , *N* -dimethyl-5-(4-methylphenyl)-1H-imidazole-1-sulfonamide, and its metabolite CCIM, 4-chloro-5-(4-methylphenyl)-1H-imidazole-2-carbonitrile, expressed as cyazofamid, in or on carrot, roots at 0.06 parts per million (ppm). That notice referenced a summary of the petition prepared by ISK Biosciences Corporation, the registrant, which is available to the public in the docket, *http://www.regulations.gov* . There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, EPA has modified the tolerance level for carrot roots. The reason for this change is explained in Unit IV.C. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue.” Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for combined residues of cyazofamid and its metabolite CCIM on carrot, roots at 0.09 ppm. EPA's assessment of exposures and risks associated with establishing tolerances follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Cyazofamid has a low order of acute toxicity via the oral, dermal and inhalation routes of exposure. Cyazofamid produces minimal but reversible eye irritation, is a slight dermal irritant and is a weak dermal sensitizer. In subchronic toxicity studies in rats cyazofamid exhibited mild or low toxicity with the kidney being the primary target organ. Kidney effects included an increased number of “basophilic kidney tubules” and mild increases in urinary volume, pH, and protein. No adverse kidney effects or any other toxicity findings were noted in chronic toxicity studies in rats. Similarly, cyazofamid's overall toxicity profile in dogs seems to be limited. In both the 13 week and one year dog studies, there were no major toxicity findings up to a dose of 1,000 milligrams/kilogram body weight/day (mg/kg/bwt day). The only possible effect was increased cysts in parathyroids of both sexes and the pituitary in females observed in the high dose groups of the one year study. Skin lesions, which may be due to systemic allergy, were observed in the males of the 18 month mouse carcinogenicity study. At the high dose, approaching 1,000 mg/kg/day, male mice suffered hair loss due to scratching, which was confirmed at necropsy by increased incidence of body sores (head, neck, trunk, limb, and/or tail) and was correlated histologically with an increased incidence of acanthosis (hyperplasia), chronic active dermatitis, ulceration, and premature death. The sulfonamide moiety in the cyanoimidazole ring might have rendered cyazofamid an allergen, albeit a weak one. This is supported by the findings that cyazofamid is a moderate irritant in the primary rabbit skin test and is a positive weak sensitizer in the guinea pig skin maximization test. There were no skin allergies in the rat feeding study, which may be due to possible species variation. There were no maternal or developmental effects observed in the prenatal developmental toxicity study in rabbits and no maternal, reproductive or offspring effects in the 2-generation reproduction study in rats. There was some evidence of increased susceptibility following *in utero* exposure of rats in the prenatal developmental toxicity study. At the highest dose tested
(HDT)(1,000 mg/kg/day), developmental effects (increased incidence of bent ribs) were observed in the absence of maternal toxicity. There were no indications of treatment-related adverse neurotoxicity findings including clinical signs, qualitative or quantitative neurobehavioral effects, brain weight, or gross/microscopic pathology in the acute neurotoxicity study and no evidence of neurotoxicity in other available studies for cyazofamid. There was no evidence of carcinogenicity in the rat and mouse carcinogenicity studies and no evidence that cyazofamid is mutagenic in several *in vivo* and *in vitro* studies. Based on the results of these studies, EPA has classified cyazofamid as “not likely to be carcinogenic to humans.” Specific information on the studies received and the nature of the adverse effects caused by cyazofamid as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *http://www.regulations.gov* in document *Human Health Risk Assessment to Support the Registration of Cyazofamid for Use on Carrot* at pages 10 to 17 in docket ID number EPA-HQ-OPP-2007-0872. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure
(POD)is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) or a Benchmark Dose
(BMD)approach is sometimes used for risk assessment. Uncertainty/safety factors
(UFs)are used in conjunction with the POD to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic dietary risks by comparing aggregate food and water exposure to the pesticide to the acute population adjusted dose
(aPAD)and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the POD by all applicable UFs. Aggregate short, intermediate, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure
(MOE)called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see *http://www.epa.gov/pesticides/factsheets/riskassess.htm* . A summary of the toxicological endpoints for cyazofamid used for human risk assessment can be found at *http://www.regulations.gov* in document *Human Health Risk Assessment to Support the Registration of Cyazofamid for Use on Carrot* at pages 18 to 21 in docket ID number EPA-HQ-OPP-2007-0872. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to cyazofamid, EPA considered exposure under the petitioned-for tolerances as well as all existing cyazofamid tolerances in 40 CFR 180.601. EPA assessed dietary exposures from cyazofamid in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. EPA identified such an effect (increased incidence of bent ribs in the rat prenatal developmental toxicity study) for the population subgroup, females, 13 to 50 years old; however, no such effect was identified for the general population, including infants and children. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture
(USDA)1994-1996 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed tolerance-level residues and 100 PCT for all existing and new uses of cyazofamid. Default processing factors were set to 1x based on the results of processing studies indicating that residues of cyazofamid do not concentrate in processed commodities. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As in the acute dietary exposure assessment, EPA assumed tolerance-level residues and 100 PCT for all existing and new uses of cyazofamid and processing factors of 1x for all processed commodities. iii. *Cancer* . Based on the results of carcinogenicity studies in rats and mice, EPA classified cyazofamid as “not likely to be carcinogenic to humans.” Therefore, a cancer exposure assessment was not conducted. iv. *Anticipated residue and PCT information* . EPA did not use anticipated residue or PCT information in the dietary assessment for cyazofamid. Tolerance-level residues and 100 PCT were assumed for all food commodities. 2. *Dietary exposure from drinking water* . The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for cyazofamid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of cyazofamid. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm* . Available environmental fate studies suggest cyazofamid is not very mobile and quickly degrades into a number of degradation products under different environmental conditions. Among the three major degradates for cyazofamid (CCIM, CCIM-AM, and CTCA), the two terminal ones are CCIM and CTCA. The highest estimated drinking water concentrations resulted from modeling which assumed application of 100% molar conversion of the parent into the terminal degradate CTCA. EPA used these estimates of CTCA in its dietary exposure assessments, a conservative approach that likely overestimates the exposure contribution from drinking water. Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of CTCA for acute exposures are estimated to be 136 parts per billion
(ppb)for surface water and 2.18 ppb for ground water; the EDWCs of CTCA for chronic exposures for non-cancer assessments are estimated to be 133 ppb for surface water and 2.18 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 136 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 133 ppb was used to assess the contribution to drinking water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Cyazofamid is currently registered for the following uses that could result in residential exposures: Disease control on professionally managed turf areas, such as golf courses and college/professional sports fields. EPA assessed residential exposure using the following assumptions: Application by homeowners to residential turf is prohibited. Therefore, non-occupational (i.e., residential) handler exposure is not expected and was not assessed. Short and intermediate term post-application dermal exposure is possible for recreational golfers or players of various sports who use college/professional athletic fields after cyazofamid has been applied. EPA assessed post-application exposure of adult golfers as well as young golfers (children 6-12 and children 3-5 years old). Post-application exposures on college/professional sports fields were assessed only for adults, since children are not expected to play on these types of athletic fields. The post-application exposure assessment was conducted using conservative assumptions, and the resulting exposure estimates are considered to represent high-end exposures. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” EPA has not found cyazofamid to share a common mechanism of toxicity with any other substances, and cyazofamid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that cyazofamid does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408(b)(2)(c) of FFDCA provides that EPA shall apply an additional tenfold
(10X)margin of safety for infants and children in the case of threshold effects to account for pre-natal and post-natal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. *Pre-natal and post-natal sensitivity* . The pre- and post-natal toxicology database for cyazofamid includes rat and rabbit developmental toxicity studies and a 2-generation reproduction toxicity study in rats. In the prenatal developmental toxicity study in rabbits, there were no maternal or developmental effects at any dose up to the limit dose of 1,000 mg/kg/day. Similarly, in the 2-generation reproduction study, the HDT (>1,000 mg/kg/day) did not cause maternal systemic, reproductive or offspring toxicity. There was some evidence of increased susceptibility following *in utero* exposure of rats in the prenatal developmental toxicity study. At the HDT (1,000 mg/kg/day), developmental effects (increased incidence of bent ribs) were observed in the absence of maternal toxicity. EPA concluded that the concern is low for the quantitative susceptibility seen in the rat developmental toxicity study and that there are no residual uncertainties because: i. The developmental effect is well identified with clear NOAEL/LOAEL; ii. The developmental effect (increased bent ribs) is a reversible variation rather than a malformation; iii. The developmental effect is seen only at the limit dose of 1,000 mg/kg/day; iv. This endpoint is used to establish the acute RfD for Females 13-49; and v. The overall toxicity profile indicates that cyazofamid is not a very toxic compound. 3. *Conclusion* . EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings: i. The toxicity database for cyazofamid is complete. ii. There is no indication that cyazofamid is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that cyazofamid results in increased susceptibility in *in utero* rabbits in the prenatal developmental study or in young rats in the 2-generation reproduction study. Although there is quantitative evidence of increased susceptibility in the pre-natal developmental study in rats, the degree of concern for pre-natal toxicity is low and the Agency did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of cyazofamid. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to cyazofamid in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children (young golfers). These assessments will not underestimate the exposure and risks posed by cyazofamid. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short, intermediate, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. *Acute risk* . An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to cyazofamid will occupy <1% of the aPAD for females 13-50 years old, the population group of concern for acute effects. Cyazofamid is not expected to pose an acute risk to the general population, including infants and children. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to cyazofamid from food and water will utilize 1.1% of the cPAD for infants less than 1 year old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of cyazofamid is not expected. 3. *Short-term risk* . Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Cyazofamid is currently registered for uses that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to cyazofamid. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures aggregated result in aggregate MOEs of 330 for adults, 7,100 for children 3-5 years old and 9,100 for children 6-12 years old. The aggregate MOE for adults includes post-application exposures on athletic fields treated with cyazofamid, the worst-case post-application exposure scenario. The aggregate MOEs for children include post-application exposure of young golfers on treated golf courses. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Cyazofamid is currently registered for uses that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure to cyazofamid through food and water with intermediate-term exposures for cyazofamid. Since the endpoints and points of departure (NOAELs) are identical for short and intermediate-term exposures, the aggregate MOEs for intermediate-term exposure are the same as those for short-term exposure (330 for adults, 7,100 for children 3-5 years old and 9,100 for children 6-12 years old). 5. *Aggregate cancer risk for U.S. population* . EPA has classified cyazofamid into the category “Not likely to be carcinogenic to humans”. Cyazofamid is not expected to pose a cancer risk. 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to cyazofamid residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate analytical methodology is available to enforce the tolerance on carrot roots. Cyazofamid and the metabolite CCIM are completely recovered (>80% recovery) using FDA's Multi-Residue Protocol D (without cleanup). In addition, the petitioner has submitted the results of an Independent Laboratory Validation
(ILV)for an HPLC/UV method (high performance liquid chromatography method using an ultra violet detector) which can be used as a single analyte confirmatory method. The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:
(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits There are no maximum residue limits
(MRLs)established by Codex, Canada or Mexico for cyazofamid. C. Revisions to Petitioned-For Tolerances Based upon review of the data supporting the petition, EPA determined that the proposed tolerance on “carrot, roots” should be increased from 0.06 ppm to 0.09 ppm. EPA revised the tolerance level based on analysis of the residue field trial data using the Agency's Tolerance Spreadsheet in accordance with the Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial Data. V. Conclusion Therefore, a tolerance is established for combined residues of cyazofamid, 4-chloro-2-cyano- *N* , *N* -dimethyl-5-(4-methylphenyl)-1H-imidazole-1-sulfonamide, and its metabolite CCIM, 4-chloro-5-(4-methylphenyl)-1H-imidazole-2-carbonitrile, expressed as cyazofamid, in or on carrot, roots at 0.09 ppm. VI. Statutory and Executive Order Reviews This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq* .) do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: April 10, 2008. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.601 is amended by alphabetically adding the following commodity to the table in paragraph
(a)to read as follows: § 180.601 Cyazofamid; tolerances for residues.
(a)* * * Commodity Parts per million Carrot, roots 0.09 * * * * * [FR Doc. E8-8371 Filed 4-22-08; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2008-0003; FRL-8359-7] Pyraclostrobin; Pesticide Tolerance for Emergency Exemptions AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a time-limited tolerance for combined residues of the fungicide pyraclostrobin (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy metabolite (methyl-N-[[[1-(4-chlorophenyl) pyrazol-3-yl]oxy]o-tolyl]carbamate), expressed as parent compound, in or on Belgian endive. This action is in response to EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing post harvest use of the pesticide on endive, Belgian to control the fungal pathogen, *Sclerotinia sclerotiorum* . This regulation establishes a maximum permissible level for residues of pyraclostrobin in this food commodity. The time-limited tolerance expires and is revoked on December 31, 2009. DATES: This regulation is effective April 23, 2008. Objections and requests for hearings must be received on or before June 23, 2008, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2008-0003. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the Office of Pesticide Programs
(OPP)Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Stacey Groce, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305-2505; e-mail address: *groce.stacey@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2008-0003 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before June 23, 2008. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2008-0003, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. II. Background and Statutory Findings EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing a time-limited tolerance for combined residues of the fungicide, pyraclostrobin, in or on endive, Belgian at 11.0 parts per million (ppm). This time-limited tolerance expires and is revoked on December 31, 2009. EPA will publish a document in the **Federal Register** to remove the revoked tolerance from the CFR. Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related time-limited tolerances to set binding precedents for the application of section 408 of FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a time-limited tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” EPA has established regulations governing such emergency exemptions in 40 CFR part 166. III. Emergency Exemption for Pyraclostrobin on Endive, Belgian and FFDCA Tolerances The California Environmental Protection Agency, Department of Pesticide Regulation, utilized the crisis provision under section 18 of FIFRA for emergency use of pyraclostrobin as a post harvest treatment on chicory roots to control fungal growth of *Sclerotinia sclerotiorum* during cold storage. According to the applicant, portions of the dormant roots are periodically removed from cold storage and propagated in sheds within a controlled environment in order to stimulate bud development. These edible buds are known as Belgian endives, and are marketed. Based on information provided in the submission, an emergency situation exists because the pathogen, *Sclerotinia sclerotiorum* , resides in field soils and can grow on the chicory root during cold storage, which makes the produce unmarketable. The state's application asserts there are currently no other fungicides registered for the post harvest treatment of chicory root to control fungal growth. Further, the State claims that good agricultural practices are not sufficient to suppress this fungal pathogen. EPA has authorized a crisis exemption for the California Department of Pesticide Regulation under FIFRA section 18 for the use of pyraclostrobin on endive, Belgian for control of *Sclerotinia sclerotiorum* . The crisis exemption program ended on January 31, 2008. As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of pyraclostrobin in or on endive, Belgian. In doing so, EPA considered the safety standard in section 408(b)(2) of FFDCA, and EPA decided that the necessary time-limited tolerance under section 408(l)(6) of FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this time-limited tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of FFDCA. Although this time-limited tolerance expires and is revoked on December 31, 2009, under section 408(l)(5) of FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on endive, Belgian after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke this time-limited tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Because this time-limited tolerance is being approved under emergency conditions, EPA has not made any final decisions about whether pyraclostrobin meets FIFRA's registration requirements for use on endive, Belgian or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of pyraclostrobin by a State for special local needs under FIFRA section 24(c). Nor does this time-limited tolerance serve as the basis for persons in any State other than California to use this pesticide on this crop under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for pyraclostrobin, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT . IV. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a time-limited tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see *http:www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . Consistent with the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure expected as a result of this emergency exemption request and the time-limited tolerance for combined residues of pyraclostrobin on endive, Belgian at 11.0 ppm. EPA's assessment of exposures and risks associated with establishing a time-limited tolerance follows. In the **Federal Register** of September 26, 2007 (72 FR 54564, FRL-8148-6), EPA published a final rule establishing tolerances for the combined residues of pyraclostrobin and its desmethoxy metabolite in or on berry, group 13; cotton, undelinted seed; and cotton, gin byproducts. When the Agency conducted the risk assessments in support of the above referenced tolerance action, EPA also assessed data submitted in the California Department of Environmental Protection emergency exemption request from trials that used backpack sprayers in both pre-cold storage and pre-forcing trays. This assessment determined that the backpack sprayer trials reflected the worse-case scenario and that the Agency could support the section 18 request and grant a time-limited tolerance of 11 ppm on Belgian endive. This time-limited tolerance is expected to adequately cover any pyraclostrobin residues using the backpack sprayer application method. The values for combined pyraclostrobin residues were used to calculate the appropriate tolerance for Belgian endive. A detailed summary of this evaluation can be found in the document dated May 30, 2007 entitled, “Pyraclostrobin. Amendment. Petition for Tolerance on Belgian endive. Additional Discussion of Residue Data and Its Use For Adjustment of Previous Tolerance Recommendation” by going to *http://www.regulations.gov* . The referenced document is available in the docket established by this action, which is described under ADDRESSES , and is identified as EPA-HQ-OPP-2008-0003 in that docket. Locate and click on the hyperlink for docket ID number EPA-HQ-OPP-2008-0003. Double-click on the document to view the referenced information of page 2 of 8. Since EPA calculated a time-limited tolerance of 11.0 ppm for Belgian endive in the May 30, 2007 amendment, the establishment of this time-limited tolerance will not change the estimated aggregate risks resulting from use of pyraclostrobin as discussed in the final rule published in the **Federal Register** on September 26, 2007. Refer to this **Federal Register** document available at *http://www.regulations.gov* for a more detailed discussion of the aggregate risk assessments and determination of safety. EPA relies upon those risk assessments and the findings made in the **Federal Register** document in support of this action as well as the amendment dated May 30, 2007 referenced in Unit. IV. Refer to docket ID number EPA-HQ-OPP-2008-0003 at *http://www.regulations.gov* for a detailed review of this document. Based on the risk assessments discussed in the final rule published in the **Federal Register** on September 26, 2007, (72 FR 54564, FRL-8148-6), and the document “Pyraclostrobin. Amendment. Petition for Tolerance on Belgian endive. Additional Discussion of Residue Data and Its Use For Adjustment of Previous Tolerance Recommendation,” EPA concludes that there is reasonable certainty that no harm will result to the general population and to infants and children from aggregate exposure to the combined residues of pyraclostrobin. V. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (a liquid chromatography/mass spectrometry (LC/MS/MS) method (BASF Method D9808), and a high performance liquid chromatography/ultraviolet (HPLC/UV) method (BASF Method D9904)) is available to enforce the tolerance expression. The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:
(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits There are no established or proposed Codex Maximum Residue Limits
(MRLs)for pyraclostrobin. There are no Canadian or Mexican MRLs established for Belgian endive. VI. Conclusion Therefore, a time-limited tolerance is established for combined residues of pyraclostrobin, (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl] phenyl]methoxy-, methyl ester) and its desmethoxy metabolite (methyl-N-[[[1-(4-chlorophenyl) pyrazol-3-yl]oxy]o-tolyl]carbamate), expressed as parent compound, in or on endive, Belgian at 11.0 ppm. This tolerance expires and is revoked on December 31, 2009. VII. Statutory and Executive Order Reviews This final rule establishes tolerances under sections 408(e) and 408(l)(6) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established in accordance with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq* .) do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 9, 2000) do not apply to this rule. In addition, this rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VIII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: April 7, 2008. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.582 is amended by alphabetically adding text to paragraph
(b)after the paragraph heading to read as follows: § 180.582 Pyraclostrobin; tolerances for residues. (b)* * * A time-limited tolerance is established for combined residues of the fungicide pyraclostrobin, (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl] phenyl]methoxy-, methyl ester) and its desmethoxy metabolite (methyl-N-[[[1-(4-chlorophenyl) pyrazol-3-yl]oxy]o-tolyl]carbamate) in connection with use of the pesticide under section 18 emergency exemptions granted by EPA. The time-limited tolerance will expire and is revoked on the date specified in the following table. Commodity Parts per million Expiration/revocation date Endive, Belgian 11.0 12/31/09 [FR Doc. E8-8675 Filed 4-22-08; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 271 [EPA-R08-RCRA-2006-0127; FRL-8556-7] Utah: Final Authorization of State Hazardous Waste Management Program Revisions AGENCY: Environmental Protection Agency (EPA). ACTION: Withdrawal of immediate final rule. SUMMARY: EPA is withdrawing the immediate final rule, Utah: Final Authorization of State Hazardous Waste Management Program Revisions, published on March 7, 2008 at 73 FR 12277, which authorized revisions to Utah's hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA stated in the immediate final rule that if EPA received comments that oppose this authorization, EPA would publish a timely notice of withdrawal in the **Federal Register** . Since EPA did receive comments that oppose this action, EPA is withdrawing the immediate final rule. EPA will address these comments in a subsequent final action based on the proposed rule also published on March 7, 2008, at 73 FR 12340. DATES: As of April 23, 2008, EPA withdraws the immediate final rule published on March 7, 2008, at 73 FR 12277. FOR FURTHER INFORMATION CONTACT: Carl Daly, Solid and Hazardous Waste Program, U.S. Environmental Protection Agency, Region 8, 1595 Wynkoop Street, Denver, Colorado 80202,
(303)312-6416, *daly.carl@epa.gov* . SUPPLEMENTARY INFORMATION: EPA is withdrawing the immediate final rule, Utah: Final Authorization of State Hazardous Waste Management Program Revisions, published on March 7, 2008, at 73 FR 12277, which intended to grant authorization for revisions to Utah's hazardous waste program. EPA stated in the immediate final rule that if EPA received comments that opposed this action, EPA would publish a timely notice of withdrawal in the **Federal Register** . Since EPA did receive adverse comments, EPA is withdrawing the immediate final rule. EPA will address all comments in a subsequent final action based on the proposed rule previously published on March 7, 2008, at 73 FR 12340. EPA will not provide for additional public comment during the final action. Dated: April 15, 2008. Robert E. Roberts, Regional Administrator, Region 8. [FR Doc. E8-8799 Filed 4-22-08; 8:45 am] BILLING CODE 6560-50-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 64 [CG Docket No. 03-123; DA 08-312] Telecommunications Relay Services and Speech-to-Speech Services for Individuals with Hearing and Speech Disabilities; Request for Stay Pending Judicial Review AGENCY: Federal Communications Commission. ACTION: Final rule; stay of effectiveness. SUMMARY: In this document, the Consumer and Governmental Affairs Bureau (Bureau) grants a request to stay the effectiveness of paragraphs 95 and 96 of the *2007 TRS Cost Recovery Declaratory Ruling,* which restrict telecommunications relay service
(TRS)providers from using consumer or call databases to contact TRS users. Because these paragraphs have been challenged in the Court of Appeals, a stay is appropriate pending review of the argument that these paragraphs violate the First Amendment rights of providers. DATES: Paragraphs 95 and 96 of the *2007 TRS Cost Recovery Declaratory Ruling,* as summarized in paragraph 24, published at 73 FR 3197, January 17, 2008, are stayed for 90 days, starting February 7, 2008. ADDRESSES: Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: Thomas Chandler, Consumer and Governmental Affairs Bureau, Disability Rights Office at
(202)418-1475 (voice),
(202)418-0597 (TTY), or e-mail at *Thomas.Chandler@fcc.gov.* SUPPLEMENTARY INFORMATION: This is a summary of the Bureau's Order, DA 08-312, *Telecommunications Relay Services and Speech-to-Speech Services for Individuals with Hearing and Speech Disabilities; Request for Stay Pending Judicial Review,* CG Docket No. 03-123, Order, 23 FCC Rcd 1705 (CGB 2008), adopted and released February 7, 2008. The full text of DA 08-312 and copies of any subsequently filed documents in this matter will be available for public inspection and copying during regular business hours at the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC 20554. DA 08-312 and copies of subsequently filed documents in this matter also may be purchased from the Commission's duplicating contractor at Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554. Customers may contact the Commission's duplicating contractor at its Web site *www.bcpiweb.com* or by calling 1-800-378-3160. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an e-mail to *fcc504@fcc.gov* or call the Consumer and Governmental Affairs Bureau at
(202)418-0530 (voice) or
(202)418-0432 (TTY). DA 08-312 also can be downloaded in Word or Portable Document Format
(PDF)at: *http://www.fcc.gov/cgb/dro/trs.html#orders* . Synopsis 1. On November 19, 2007, the Commission released *Telecommunications Relay Services and Speech-to-Speech Services for Individuals with Hearing and Speech Disabilities,* CG Docket No. 03-123, Report and Order and Declaratory Ruling, 22 FCC Rcd 20140
(2007)( *2007 TRS Cost Recovery Declaratory Ruling* ), published at 73 FR 3197, January 17, 2008, which, among other things, prohibits providers from using a consumer or call database to contact TRS users “for lobbying or any other purpose,” and prohibits providers from using a consumer or call database to “contact TRS users or to in any way attempt to affect or influence, directly or indirectly, their use of relay service.” *2007 TRS Cost Recovery Declaratory Ruling, 22 FCC Rcd* at 20176, paras. 95-96. On January 16, 2008, Sorenson Communications, Inc. (Sorenson) filed a Petition for Review in the United States Court of Appeals for the Tenth Circuit asserting, in part, that the above-quoted language violates the First Amendment rights of TRS providers. On January 28, 2008, Sorenson filed with the Commission a request for a stay of paragraphs 95 and 96 pending judicial review. Sorenson Communications, Inc., *Request for Stay Pending Judicial Review,* CG Docket No. 03-123 (filed Jan. 28, 2008) ( *Stay Request* ). 2. In its *Stay Request,* Sorenson contends that it has a substantial likelihood of prevailing on the merits of the judicial review proceeding in the Tenth Circuit because paragraphs 95 and 96 of the *2007 TRS Cost Recovery Declaratory Ruling* violate Sorenson's First Amendment rights by “limiting [its] ability to engage in core political speech and to petition the government for redress of grievances” and by “restrict[ing] [its] ability to engage in protected commercial speech.” Although Sorenson does not dispute that the Commission has a substantial interest in preventing providers from using customer call data to offer TRS users financial incentives to make unnecessary TRS calls, it contends that the Commission has no substantial interest in preventing providers from contacting users for other reasons, including to assist them with service issues, to educate them about new service features, or to inform them of potential misuse of the service by third parties. Sorenson also asserts that, absent a stay, it will suffer irreparable harm through the loss of its First Amendment rights and harm to its business as a result of its inability to warn its users of scams and abusive relay practices. Sorenson further asserts that a stay will not injure other parties, as it will simply preserve the *status quo.* Finally, Sorenson asserts that a stay is in the public interest because the challenged restrictions run afoul of the First Amendment and impair the ability of TRS users to learn about developments in the provision of relay service. 3. In considering requests for stay, the Commission generally considers the four criteria set forth in *Virginia Petroleum Jobbers Association* v. *Federal Power Commission,* 259 F.2d 921, 925 (DC Cir. 1958). These criteria are:
(1)A likelihood of success on the merits;
(2)the threat of irreparable harm absent the grant of preliminary relief;
(3)the degree of injury to other parties if relief is granted; and
(4)the issuance of the order will further the public interest. As the Commission has explained, the relative importance of the four criteria will vary depending upon the circumstances of the case. If there is a particularly overwhelming showing in at least one of the factors, the Commission may find that a stay is warranted notwithstanding the absence of another one of the factors. 4. The Bureau agrees that a temporary stay of paragraphs 95 and 96 of the *2007 TRS Cost Recovery Declaratory Ruling* is appropriate under the circumstances presented. Specifically, the Bureau concludes that a stay will further the public interest. The Bureau notes that Sorenson and other providers have raised several concerns, including their asserted inability to contact users for emergency or consumer protection-related purposes, that, if borne out by further Commission examination, may cause the Commission to reconsider the language of paragraphs 95 and 96 of the *2007 TRS Cost Recovery Declaratory Ruling.* In order to provide the Commission with sufficient time to consider the arguments presented by Sorenson and others, the Bureau finds that a temporary stay of those paragraphs is warranted. The Bureau therefore finds that it is in the public interest to grant the requested stay for a period of 90 days, starting February 7, 2008. Ordering Clause Pursuant to section 4(i) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), and the authority delegated under §§ 0.141 and 0.361 of the Commission's rules, 47 CFR 0.141, 0.361, the Request for Stay filed by Sorenson Communications, Inc. on January 28, 2008, is *granted,* and will remain in effect for a period of 90 days, starting February 7, 2008. Federal Communications Commission. Nicole McGinnis, Deputy Chief, Consumer and Governmental Affairs Bureau. [FR Doc. E8-8793 Filed 4-22-08; 8:45 am] BILLING CODE 6712-01-P DEPARTMENT OF DEFENSE Defense Acquisition Regulations System 48 CFR Part 201 Defense Federal Acquisition Regulation Supplement; Technical Amendments AGENCY: Defense Acquisition Regulations System, Department of Defense (DoD). ACTION: Final rule. SUMMARY: DoD is making technical amendments to the Defense Federal Acquisition Regulation Supplement (DFARS) to update a subpart heading and a reference to a DoD publication. EFFECTIVE DATE: April 23, 2008. FOR FURTHER INFORMATION CONTACT: Ms. Michele Peterson, Defense Acquisition Regulations System, OUSD (AT&L) DPAP (DARS), IMD 3D139, 3062 Defense Pentagon, Washington, DC 20301-3062. Telephone 703-602-0311; facsimile 703-602-7887. SUPPLEMENTARY INFORMATION: This final rule amends DFARS text as follows: ○ *Subpart 201.6.* Revises the subpart heading for consistency with the corresponding subpart of the Federal Acquisition Regulation. ○ *Section 201.603-2.* Updates references to a DoD publication addressing career development. List of Subjects in 48 CFR Part 201 Government procurement. Michele P. Peterson, Editor, Defense Acquisition Regulations System. Therefore, 48 CFR Part 201 is amended as follows: PART 201—FEDERAL ACQUISITION REGULATIONS SYSTEM 1. The authority citation for 48 CFR Part 201 continues to read as follows: Authority: 41 U.S.C. 421 and 48 CFR Chapter 1. 2. The heading of subpart 201.6 is revised to read as follows: Subpart 201.6—Career Development, Contracting Authority, and Responsibilities 3. Section 201.603-2 is amended by revising the second sentence of paragraph (2)(iii) and the second sentence of paragraph
(3)to read as follows: 201.603-2 Selection.
(2)* * *
(iii)* * * Information on developmental opportunities is contained in DoD Instruction 5000.66, Operation of the Defense Acquisition, Technology, and Logistics Workforce Education, Training, and Career Development Program.
(3)* * * Information on waivers is contained in DoD Instruction 5000.66. [FR Doc. E8-8698 Filed 4-22-08; 8:45 am] BILLING CODE 5001-08-P DEPARTMENT OF DEFENSE Defense Acquisition Regulations System 48 CFR Part 212 RIN 0750-AF93 Defense Federal Acquisition Regulation Supplement; Extension of Authority To Carry Out Certain Prototype Projects (DFARS Case 2008-D008) AGENCY: Defense Acquisition Regulations System, Department of Defense (DoD). ACTION: Final rule. SUMMARY: DoD has issued a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement Section 823 of the National Defense Authorization Act for Fiscal Year 2008. Section 823 provides a 5-year extension of the authority for DoD to carry out a pilot program for transition to follow-on contracting after use of other transaction authority. EFFECTIVE DATE: April 23, 2008. FOR FURTHER INFORMATION CONTACT: Ms. Felisha Hitt, Defense Acquisition Regulations System, OUSD (AT&L) DPAP (DARS), IMD 3D139, 3062 Defense Pentagon, Washington, DC 20301-3062. Telephone 703-602-0310; facsimile 703-602-7887. Please cite DFARS Case 2008-D008. SUPPLEMENTARY INFORMATION: A. Background This final rule implements Section 823 of the National Defense Authorization Act for Fiscal Year 2008 (Pub. L. 110-181). Section 823 amended Section 845 of the National Defense Authorization Act for Fiscal Year 1994 (as amended by Section 847 of the National Defense Authorization Act for Fiscal Year 2004) (10 U.S.C. 2371 note), to provide a 5-year extension of the authority for DoD to carry out a pilot program for follow-on contracting for the production of items or processes begun as prototype projects under other transaction agreements. Items or processes that do not otherwise meet the definition of “commercial item” may be treated as commercial items in the award of contracts and subcontracts under the pilot program. In addition, items or processes acquired under the pilot program may be treated as developed in part with Federal funds and in part at private expense for purposes of negotiating rights in technical data. The pilot program is addressed in DFARS Subpart 212.70. Accordingly, DFARS Subpart 212.70 is amended to reflect the extended expiration date, from September 30, 2008, to September 30, 2013. This rule was not subject to Office of Management and Budget review under Executive Order 12866, dated September 30, 1993. B. Regulatory Flexibility Act This rule will not have a significant cost or administrative impact on contractors or offerors, or a significant effect beyond the internal operating procedures of DoD. Therefore, publication for public comment under 41 U.S.C. 418b is not required. However, DoD will consider comments from small entities concerning the affected DFARS subpart in accordance with 5 U.S.C. 610. Such comments should cite DFARS Case 2008-D008. C. Paperwork Reduction Act The Paperwork Reduction Act does not apply, because the rule does not impose any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, *et seq.* List of Subjects in 48 CFR Part 212 Government procurement. Michele P. Peterson, Editor, Defense Acquisition Regulations System. Therefore, 48 CFR Part 212 is amended as follows: PART 212—ACQUISITION OF COMMERCIAL ITEMS 1. The authority citation for 48 CFR part 212 continues to read as follows: Authority: 41 U.S.C. 421 and 48 CFR Chapter 1. 212.7002-1 [Amended] 2. Section 212.7002-1 is amended in paragraph (a)(4) by removing “2008” and adding in its place “2013”. 212.7002-2 [Amended] 3. Section 212.7002-2 is amended in paragraph (a)(3) by removing “2008” and adding in its place “2013”. [FR Doc. E8-8695 Filed 4-22-08; 8:45 am] BILLING CODE 5001-08-P DEPARTMENT OF DEFENSE Defense Acquisition Regulations System 48 CFR Parts 225 and 252 RIN 0750-AF91 Defense Federal Acquisition Regulation Supplement; Deletion of Obsolete Restriction on Acquisition of Vessel Propellers (DFARS Case 2007-D027) AGENCY: Defense Acquisition Regulations System, Department of Defense (DoD). ACTION: Final rule. SUMMARY: DoD has issued a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to remove text addressing an obsolete restriction on the acquisition of vessel propellers from foreign sources. The statute upon which the restriction was based applied only to acquisitions using fiscal year 2000 or 2001 funds. EFFECTIVE DATE: April 23, 2008. FOR FURTHER INFORMATION CONTACT: Ms. Amy Williams, Defense Acquisition Regulations System, OUSD(AT&L)DPAP(DARS), IMD 3D139, 3062 Defense Pentagon, Washington, DC 20301-3062. Telephone 703-602-0328; facsimile 703-602-7887. Please cite DFARS Case 2007-D027. SUPPLEMENTARY INFORMATION: A. Background The text at DFARS 225.7010 through 225.7010-4, and the corresponding contract clause at DFARS 252.225-7023, were added on December 13, 2000 (65 FR 77827), to implement provisions of Section 8064 of the Fiscal Year 2001 DoD Appropriations Act (Pub. L. 106-259) relating to vessel propellers. Section 8064 prohibited the use of fiscal year 2000 or 2001 DoD appropriated funds for the procurement of vessel propellers, other than those produced by a domestic source and of domestic origin, unless an exception applied or a waiver was granted. This prohibition was not repeated in subsequent appropriations acts and, therefore, is removed from the DFARS. This rule was not subject to Office of Management and Budget review under Executive Order 12866, dated September 30, 1993. B. Regulatory Flexibility Act This rule will not have a significant cost or administrative impact on contractors or offerors, or a significant effect beyond the internal operating procedures of DoD. Therefore, publication for public comment under 41 U.S.C. 418b is not required. However, DoD will consider comments from small entities concerning the affected DFARS subparts in accordance with 5 U.S.C. 610. Such comments should cite DFARS Case 2007-D027. C. Paperwork Reduction Act The Paperwork Reduction Act does not apply, because the rule does not impose any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, *et seq.* List of Subjects in 48 CFR Parts 225 and 252 Government procurement. Michele P. Peterson, Editor, Defense Acquisition Regulations System. Therefore, 48 CFR parts 225 and 252 are amended as follows: 1. The authority citation for 48 CFR parts 225 and 252 continues to read as follows: Authority: 41 U.S.C. 421 and 48 CFR Chapter 1. PART 225—FOREIGN ACQUISITION 225.7010 [Removed and Reserved] 2. Section 225.7010 is removed and reserved. 225.7010-1 through 225.7010-4 [Removed] 3. Sections 225.7010-1 through 225.7010-4 are removed. PART 252—SOLICITATION PROVISIONS AND CONTRACT CLAUSES 252.225-7023 [Removed and Reserved] 4. Section 252.225-7023 is removed and reserved. [FR Doc. E8-8694 Filed 4-22-08; 8:45 am] BILLING CODE 5001-08-P DEPARTMENT OF DEFENSE Defense Acquisition Regulations System 48 CFR Parts 234, 242, and 252 RIN 0750-AF19 Defense Federal Acquisition Regulation Supplement; Earned Value Management Systems (DFARS Case 2005-D006) AGENCY: Defense Acquisition Regulations System, Department of Defense (DoD). ACTION: Final rule. SUMMARY: DoD has issued a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to update requirements for DoD contractors to establish and maintain earned value management systems. The rule also eliminates requirements for DoD contractors to submit cost/schedule status reports. EFFECTIVE DATE: April 23, 2008. FOR FURTHER INFORMATION CONTACT: Mr. Mark Gomersall, Defense Acquisition Regulations System, OUSD (AT&L) DPAP (DARS), IMD 3D139, 3062 Defense Pentagon, Washington, DC 20301-3062. Telephone 703-602-0302; facsimile 703-602-7887. Please cite DFARS Case 2005-D006. SUPPLEMENTARY INFORMATION: A. Background This final rule updates DFARS text addressing earned value management policy for DoD contracts. The rule supplements the final FAR rule published at 71 FR 38238 on July 5, 2006, and establishes DoD-specific earned value management requirements, as permitted by the FAR. The DFARS rule is consistent with the policy in the memorandum issued by the Under Secretary of Defense (Acquisition, Technology, and Logistics) on March 7, 2005, *Subject:* Revision to DoD Earned Value Management Policy (available at *http://www.acq.osd.mil/dpap/ops/policy_vault.html).* The DFARS changes in this rule include the following: ○ For cost or incentive contracts and subcontracts valued at $20,000,000 or more, the rule requires an earned value management system that complies with the guidelines in the American National Standards Institute/Electronic Industries Alliance Standard 748, Earned Value Management Systems (ANSI/EIA-748). ○ For cost or incentive contracts and subcontracts valued at $50,000,000 or more, the rule requires an earned value management system that has been determined by the cognizant Federal agency (as defined in FAR 2.101) to be in compliance with the guidelines in ANSI/EIA-748. ○ For cost or incentive contracts and subcontracts valued at less than $20,000,000, the rule provides that application of earned value management is optional and is a risk-based decision. ○ For firm-fixed-price contracts and subcontracts of any dollar value, the rule discourages the application of earned value management. ○ The Defense Contract Management Agency is assigned responsibility for determining earned value management compliance when DoD is the cognizant Federal agency. ○ Requirements for contractor cost/schedule status reports are eliminated. DoD published a proposed rule at 71 FR 3449 on January 23, 2006. Five sources submitted comments on the proposed rule. A discussion of the comments is provided below. 1. *Comment:* One respondent stated that the $20,000,000 threshold for earned value management
(EVM)further aggravates the ability to mitigate cost, schedule, and technical risks, since receiving EVM data below that threshold would be helpful in assisting leadership to make affordable decisions. *DoD Response:* The rule allows for EVM below the $20,000,000 threshold when its application is determined to be appropriate as the result of a cost-benefit analysis. 2. *Comment:* Two respondents stated that the rule should be revised to specifically state that EVM requirements do not apply to time-and-materials, labor-hour, and level-of-effort contracts. *DoD Response:* The rule requires EVM to be applied only on cost and incentive type contracts and subcontracts over certain thresholds. EVM is discouraged on firm-fixed-price contracts and subcontracts of any dollar value. Further, performance-based acquisition management on developmental efforts, as described in OMB Circular A-11, Part 7, focuses on the use of EVM on cost and incentive type contracts. 3. *Comment:* One respondent expressed support of the rule, but urged that the Defense Acquisition Regulations Council work with the Civilian Agency Acquisition Council to ensure that the final FAR rule is consistent with the DFARS rule. In particular, the respondent stated that the FAR rule should be revised in four areas to make it consistent with the DFARS rule as follows: Explicitly limit application of EVM requirements to cost or incentive contracts; establish a fixed dollar value for the applicability of EVM requirements; limit integrated baseline reviews to contract post-award; and establish an executive agency (such as the Defense Contract Management Agency (DCMA)) within the Government responsible for Government-wide EVM system compliance reviews. *DoD Response:* The respondent's recommendations regarding the FAR were addressed in the preamble to the FAR rule published at 71 FR 38238 on July 5, 2006. Additional changes have been made to the DFARS rule for consistency with the FAR rule. Those changes include: ○ Relocation of EVM policy from Part 242 to Part 234. ○ For cost or incentive contracts and subcontracts valued at $50,000,000 or more, replacement of the requirement for a contracting officer's formal validation and acceptance with the requirement for an EVM system that has been determined by the cognizant federal agency to be in compliance with the guidelines in ANSI/EIA-748. DCMA is assigned responsibility for determining EVM system compliance when DoD is the cognizant Federal agency. ○ Elimination of the text included in the proposed rule at 252.242-7006(b), which specified that the terms for compliance with ANSI/EIA-748 for contracts below $50,000,000 may be subject to negotiation between the contractor and the contracting officer; compliance with the guidelines in ANSI/EIA-748 is not subject to negotiation. ○ Addition of text in the solicitation provision at 252.234-7001(a)(2)(ii) and
(iii)to require an offeror proposing to use a system that has not been determined to be in compliance with ANSI/EIA-748, to provide information and assistance as required by the contracting officer to support review of the offeror's plan for compliance and to provide milestones that indicate when the offeror will be compliant. ○ Elimination of a separate provision and clause to address requirements for contracts valued at $20,000,000 or more but less than $50,000,000. The provision and clause at 252.234-7001 and 252.234-7002 address requirements for contracts above or below $50,000,000. 4. *Comment:* One respondent recommended that the contract clause for EVM compliance be modified to indicate that the contract performance report may be tailored in accordance with the DoD Earned Value Management Implementation Guide, in order to reduce the burden on contractors while still ensuring that DoD managers receive useful information. The memorandum issued by the Under Secretary of Defense (Acquisition, Technology, and Logistics) on March 7, 2005, indicates that the contract performance report may be tailored, based on guidance in the implementation guide, for cost or incentive contracts valued at $20 million or more but less than $50 million. *DoD Response:* DoD does not believe it is necessary to address tailoring of the contract performance report within the contract clause. The contracting officer may tailor the report in accordance with the DoD Earned Value Management Implementation Guide. A reference to the guide has been added to the DFARS companion resource, Procedures, Guidance, and Information. Any tailoring of contract performance reports for a particular contract will be documented in the contract data requirements list to ensure the contractual requirements are clear. 5. *Comment:* One respondent recommended that language be added to the contract clause to state that the contractor is responsible for ensuring that selected subcontractors comply with ANSI/EIA-748. *DoD Response:* Paragraph
(h)of the contract clause in the final rule specifies that the contractor must require certain subcontractors (or subcontractor effort if subcontractors have not been selected) to comply with the EVM requirements of the clause. This includes compliance with the EVM guidelines in ANSI/EIA-748. 6. *Comment:* One respondent recommended adding the following language to the contract clause for consistency with language included in the solicitation provision: “The terms for compliance with ANSI/EIA-748 may be subject to negotiation between the contractor and subcontractor. The conduct of the integrated baseline reviews also may be subject to negotiation between the contractor and subcontractor.” *DoD Response:* The cited language has been excluded from the final rule. The clause at 252.234-7002 requires contractors to ensure subcontractor compliance with the EVM requirements of the clause, to include compliance with the guidelines in ANSI/EIA-748. Likewise, contractors are required to ensure that any necessary participation by a subcontractor in the performance of integrated baseline reviews is in accordance with the clause. However, since integrated baseline reviews are a joint assessment between the contractor and the Government, the timing of such reviews will necessarily be coordinated between the parties. 7. *Comment:* One respondent indicated that emphasis should be placed on establishing a system that requires a company-wide commitment to standardized actual collection systems, budgeting systems, scheduling systems, status systems, change management systems, and reporting systems, rather than simply emphasizing what threshold should be used to apply EVM. *DoD Response:* The Government can not mandate contractor management and budgetary control systems used outside of Government contracts. However, contractors that are frequently awarded Government contracts that require EVM may find it in their best interests to establish company-wide standardized EVM systems that are in compliance with ANSI/EIA-748. This rule was not subject to Office of Management and Budget review under Executive Order 12866, dated September 30, 1993. B. Regulatory Flexibility Act DoD has prepared a final regulatory flexibility analysis consistent with 5 U.S.C. 604. A copy of the analysis may be obtained from the point of contact specified herein. The analysis is summarized as follows: This final rule amends the DFARS to update requirements for DoD contractors to establish and maintain earned value management systems. The rule revises the dollar thresholds at which DoD applies earned value management policy, and eliminates requirements for DoD contractors to submit cost/schedule status reports. The rule supplements the FAR rule published at 71 FR 38238 on July 5, 2006. The FAR rule provides standard earned value management policy, consistent with the requirements of OMB Circular A-11, Part 7, Planning, Budgeting, Acquisition, and Management of Capital Assets, and the supplement to Part 7, the Capital Programming Guide. The OMB Circular and its supplement implement statutory requirements for the Government to define the cost, performance, and schedule, and schedule goals for major acquisitions and to achieve, on the average, 90 percent of the established goals. The FAR rule permits agency supplementation with regard to earned value management applicability criteria, post-award review requirements, and procedures for implementation of the guidelines in American National Standards Institute/Electronic Industries Alliance Standard 748 (ANSI/EIA-748), Earned Value Management Systems. This DFARS rule establishes the DoD-specific earned value management requirements. The FAR rule permits agency supplementation with regard to earned value management applicability criteria, post-award review requirements, and procedures for implementation of the guidelines in American National Standards Institute/Electronic Industries Alliance Standard 748 (ANSI/EIA-748), Earned Value Management Systems. This DFARS rule establishes the DoD-specific earned value management requirements. The threshold at which a DoD contractor previously was required to have an earned value management system that complied with ANSI/EIA-748 was $73 million for contracts and subcontracts funded with research, development, test and evaluation funding; and $315 million for contracts and subcontracts funded with operation and maintenance or procurement funding. This DFARS rule lowers those thresholds to a single $20 million for all cost or incentive contracts and subcontracts, regardless of funding type, and establishes a new threshold of $50 million for an earned value management system that has been determined by the Government to be in compliance with ANSI/EIA-748. The rule discourages the application of earned value management requirements to fixed-price contracts and subcontracts of any dollar value. During fiscal year 2006, DoD awarded 8,266 cost or incentive contracts to small business concerns, with only 16 of those contracts exceeding $20 million in value. During the same fiscal year, DoD awarded 53,585 fixed-price type contracts to small business concerns, with only 70 of those contracts exceeding $20 million in value. The use of earned value management requirements in fixed-price contracts is expected to be rare. The DFARS rule mitigates the impact on small businesses by establishing a $20 million contract threshold for earned value management requirements, and discouraging the application of earned value management requirements to fixed-price contracts and subcontracts, thereby establishing a very small subset of the small business community for which the rule would be applicable. The cost for a small business concern to establish a compliant earned value management system would be a one-time cost that the concern may offset through cost reimbursement on the resulting Government contract. C. Paperwork Reduction Act This rule does not impose any new information collection requirements that require the approval of the Office of Management and Budget
(OMB)under 44 U.S.C. 3501, *et seq.* The contract performance reports required by the rule are approved under OMB Clearance Number 0704-0188, Acquisition Management Systems and Data Requirements Control List. List of Subjects in 48 CFR Parts 234, 242, and 252 Government procurement. Michele P. Peterson, Editor, Defense Acquisition Regulations System. Therefore, 48 CFR parts 234, 242, and 252 are amended as follows: 1. The authority citation for 48 CFR parts 234, 242, and 252 continues to read as follows: Authority: 41 U.S.C. 421 and 48 CFR Chapter 1. PART 234—MAJOR SYSTEM ACQUISITION § 234.005 [Removed] 2. Section 234.005 is removed. 3. Subpart 234.2 is added to read as follows: Subpart 234.2—Earned Value Management System Sec. 234.201 Policy. 234.203 Solicitation provisions and contract clause. Subpart 234.2—Earned Value Management System § 234.201 Policy.
(1)DoD applies the earned value management system requirement as follows:
(i)For cost or incentive contracts and subcontracts valued at $20,000,000 or more, the earned value management system shall comply with the guidelines in the American National Standards Institute/Electronic Industries Alliance Standard 748, Earned Value Management Systems (ANSI/EIA-748).
(ii)For cost or incentive contracts and subcontracts valued at $50,000,000 or more, the contractor shall have an earned value management system that has been determined by the cognizant Federal agency to be in compliance with the guidelines in ANSI/EIA-748.
(iii)For cost or incentive contracts and subcontracts valued at less than $20,000,000—
(A)The application of earned value management is optional and is a risk-based decision;
(B)A decision to apply earned value management shall be documented in the contract file; and
(C)Follow the procedures at PGI 234.201(1)(iii) for conducting a cost-benefit analysis.
(iv)For firm-fixed-price contracts and subcontracts of any dollar value—
(A)The application of earned value management is discouraged; and
(B)Follow the procedures at PGI 234.201(1)(iv) for obtaining a waiver before applying earned value management.
(2)When an offeror proposes a plan for compliance with the earned value management system guidelines in ANSI/EIA-748, follow the review procedures at PGI 234.201(2).
(3)The Defense Contract Management Agency is responsible for determining earned value management system compliance when DoD is the cognizant Federal agency.
(4)See PGI 234.201(4) for additional guidance on earned value management. 234.203 Solicitation provisions and contract clause. For cost or incentive contracts valued at $20,000,000 or more, and for other contracts for which EVMS will be applied in accordance with 234.201(1)(iii) and (iv)—
(1)Use the provision at 252.234-7001, Notice of Earned Value Management System, instead of the provisions at FAR 52.234-2, Notice of Earned Value Management System—Pre-Award IBR, and FAR 52.234-3, Notice of Earned Value Management System—Post-Award IBR, in the solicitation; and
(2)Use the clause at 252.234-7002, Earned Value Management System, instead of the clause at FAR 52.234-4, Earned Value Management System, in the solicitation and contract. PART 242—CONTRACT ADMINISTRATION AND AUDIT SERVICES 4. Section 242.1106 is amended by revising paragraph
(a)to read as follows: 242.1106 Reporting requirements.
(a)See DoDI 5000.2, Operation of the Defense Acquisition System, for reporting requirements for defense technology projects and acquisition programs. 242.1107-70 [Removed] 5. Section 242.1107-70 is removed. PART 252—SOLICITATION PROVISIONS AND CONTRACT CLAUSES 6. Sections 252.234-7001 and 252.234-7002 are added to read as follows: 252.234-7001 Notice of Earned Value Management System. As prescribed in 234.203(1), use the following provision: Notice of Earned Value Management System (Apr 2008)
(a)If the offeror submits a proposal in the amount of $50,000,000 or more—
(1)The offeror shall provide documentation that the Cognizant Federal Agency
(CFA)has determined that the proposed Earned Value Management System
(EVMS)complies with the EVMS guidelines in the American National Standards Institute/Electronic Industries Alliance Standard 748, Earned Value Management Systems (ANSI/EIA-748) (current version at time of solicitation). The Government reserves the right to perform reviews of the EVMS when deemed necessary to verify compliance.
(2)If the offeror proposes to use a system that has not been determined to be in compliance with the requirements of paragraph (a)(1) of this provision, the offeror shall submit a comprehensive plan for compliance with the guidelines in ANSI/EIA-748.
(i)The plan shall—
(A)Describe the EVMS the offeror intends to use in performance of the contract, and how the proposed EVMS complies with the EVMS guidelines in ANSI/EIA-748;
(B)Distinguish between the offeror's existing management system and modifications proposed to meet the EVMS guidelines;
(C)Describe the management system and its application in terms of the EVMS guidelines;
(D)Describe the proposed procedure for administration of the EVMS guidelines as applied to subcontractors; and
(E)Describe the process the offeror will use to determine subcontractor compliance with ANSI/EIA-748.
(ii)The offeror shall provide information and assistance as required by the Contracting Officer to support review of the plan.
(iii)The offeror's EVMS plan must provide milestones that indicate when the offeror anticipates that the EVMS will be compliant with the guidelines in ANSI/EIA-748.
(b)If the offeror submits a proposal in an amount less than $50,000,000—
(1)The offeror shall submit a written description of the management procedures it will use and maintain in the performance of any resultant contract to comply with the requirements of the Earned Value Management System clause of the contract. The description shall include—
(i)A matrix that correlates each guideline in ANSI/EIA-748 (current version at time of solicitation) to the corresponding process in the offeror's written management procedures; and
(ii)The process the offeror will use to determine subcontractor compliance with ANSI/EIA-748.
(2)If the offeror proposes to use an EVMS that has been determined by the CFA to be in compliance with the EVMS guidelines in ANSI/EIA-748, the offeror may submit a copy of the documentation of such determination instead of the written description required by paragraph (b)(1) of this provision.
(c)The offeror shall identify the subcontractors (or the subcontracted effort if subcontractors have not been selected) to whom the EVMS requirements will apply. The offeror and the Government shall agree to the subcontractors or the subcontracted effort selected for application of the EVMS requirements. The offeror shall be responsible for ensuring that the selected subcontractors comply with the requirements of the Earned Value Management System clause of the contract. (End of provision) 252.234-7002 Earned Value Management System. As prescribed in 234.203(2), use the following clause: Earned Value Management System (Apr 2008)
(a)In the performance of this contract, the Contractor shall use—
(1)An Earned Value Management System
(EVMS)that complies with the EVMS guidelines in the American National Standards Institute/Electronic Industries Alliance Standard 748, Earned Value Management Systems (ANSI/EIA-748); and
(2)Management procedures that provide for generation of timely, reliable, and verifiable information for the Contract Performance Report
(CPR)and the Integrated Master Schedule
(IMS)required by the CPR and IMS data items of this contract.
(b)If this contract has a value of $50,000,000 or more, the Contractor shall use an EVMS that has been determined by the Cognizant Federal Agency
(CFA)to be in compliance with the EVMS guidelines as stated in paragraph (a)(1) of this clause. If, at the time of award, the Contractor's EVMS has not been determined by the CFA to be in compliance with the EVMS guidelines as stated in paragraph (a)(1) of this clause, the Contractor shall apply its current system to the contract and shall take necessary actions to meet the milestones in the Contractor's EVMS plan.
(c)If this contract has a value of less than $50,000,000, the Government will not make a formal determination that the Contractor's EVMS complies with the EVMS guidelines in ANSI/EIA-748 with respect to the contract. The use of the Contractor's EVMS for this contract does not imply a Government determination of the Contractor's compliance with the EVMS guidelines in ANSI/EIA-748 for application to future contracts. The Government will allow the use of a Contractor's EVMS that has been formally reviewed and determined by the CFA to be in compliance with the EVMS guidelines in ANSI/EIA-748.
(d)The Contractor shall submit notification of any proposed substantive changes to the EVMS procedures and the impact of those changes to the CFA. If this contract has a value of $50,000,000 or more, unless a waiver is granted by the CFA, any EVMS changes proposed by the Contractor require approval of the CFA prior to implementation. The CFA will advise the Contractor of the acceptability of such changes as soon as practicable (generally within 30 calendar days) after receipt of the Contractor's notice of proposed changes. If the CFA waives the advance approval requirements, the Contractor shall disclose EVMS changes to the CFA at least 14 calendar days prior to the effective date of implementation.
(e)The Government will schedule integrated baseline reviews as early as practicable, and the review process will be conducted not later than 180 calendar days after
(1)contract award,
(2)the exercise of significant contract options, and
(3)the incorporation of major modifications. During such reviews, the Government and the Contractor will jointly assess the Contractor's baseline to be used for performance measurement to ensure complete coverage of the statement of work, logical scheduling of the work activities, adequate resourcing, and identification of inherent risks.
(f)The Contractor shall provide access to all pertinent records and data requested by the Contracting Officer or duly authorized representative as necessary to permit Government surveillance to ensure that the EVMS complies, and continues to comply, with the performance criteria referenced in paragraph
(a)of this clause.
(g)When indicated by contract performance, the Contractor shall submit a request for approval to initiate an over-target baseline or over-target schedule to the Contracting Officer. The request shall include a top-level projection of cost and/or schedule growth, a determination of whether or not performance variances will be retained, and a schedule of implementation for the rebaselining. The Government will acknowledge receipt of the request in a timely manner (generally within 30 calendar days).
(h)The Contractor shall require its subcontractors to comply with EVMS requirements as follows:
(1)For subcontracts valued at $50,000,000 or more, the following subcontractors shall comply with the requirements of this clause: *[Contracting Officer to insert names of subcontractors (or subcontracted effort if subcontractors have not been selected) designated for application of the EVMS requirements of this clause.]*
(2)For subcontracts valued at less than $50,000,000, the following subcontractors shall comply with the requirements of this clause, excluding the requirements of paragraph
(b)of this clause: *[Contracting Officer to insert names of subcontractors (or subcontracted effort if subcontractors have not been selected) designated for application of the EVMS requirements of this clause.]* (End of clause) 252.242-7001 and 252.242-7002 [Removed and Reserved] 7. Sections 252.242-7001 and 252.242-7002 are removed and reserved. 252.242-7005 and 252.242-7006 [Removed] 8. Sections 252.242-7005 and 252.242-7006 are removed. [FR Doc. E8-8706 Filed 4-22-08; 8:45 am] BILLING CODE 5001-08-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 071106673-8011-02] RIN 0648-XH33 Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Ocean Perch in the Bering Sea and Aleutian Islands Management Area AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Temporary rule; modification of a closure. SUMMARY: NMFS is opening directed fishing for Pacific ocean perch in the Eastern Aleutian District of the Bering Sea and Aleutian Islands management area
(BSAI)for vessels participating in the BSAI trawl limited access fishery. This action is necessary to fully use the 2008 total allowable catch
(TAC)of Pacific ocean perch in this area specified for vessels participating in the BSAI trawl limited access fishery. DATES: Effective 1200 hrs, Alaska local time (A.l.t.), April 18, 2008, through 2400 hrs, A.l.t., December 31, 2008. Comments must be received at the following address no later than 4:30 p.m., A.l.t., * May 5, 2008.* ADDRESSES: Send comments to Sue Salveson, Assistant Regional Administrator, Sustainable Fisheries Division, Alaska Region, NMFS, Attn: Ellen Sebastian. You may submit comments, identified by “RIN 0648-XH33,” by any one of the following methods: • Electronic Submissions: Submit all electronic public comments via the Federal eRulemaking Portal website at *http://www.regulations.gov* ; • Mail: P.O. Box 21668, Juneau, AK 99802; • Fax:
(907)586-7557; or • Hand delivery to the Federal Building: 709 West 9th Street, Room 420A, Juneau, AK. Instructions: All comments received are a part of the public record and will generally be posted to *http://www.regulations.gov* without change. All Personal Identifying Information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information. NMFS will accept anonymous comments. Attachments to electronic comments will be accepted in Microsoft Word, Excel, WordPerfect, or Adobe PDF file formats only. FOR FURTHER INFORMATION CONTACT: Jennifer Hogan, 907-586-7228. SUPPLEMENTARY INFORMATION: NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area
(FMP)prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679. NMFS closed the directed fishery for Pacific ocean perch by vessels participating in the BSAI trawl limited access fishery in the Eastern Aleutian District of the BSAI on March 19, 2008 (73 FR 15458, March 24, 2008). NMFS has determined that approximately 59 mt of the 2008 TAC of Pacific ocean perch for vessels participating in the BSAI trawl limited access fishery in the Eastern Aleutian District of the BSAI remain in the directed fishing allowance. Therefore, in accordance with § 679.25(a)(1)(i), (a)(2)(i)(C), and (a)(2)(iii)(D), and to fully utilize the 2008 TAC of Pacific ocean perch in this area specified for vessels participating in the BSAI trawl limited access fishery, NMFS is terminating the previous closure and is reopening directed fishing for Pacific ocean perch by vessels participating in the BSAI trawl limited access fishery in the Eastern Aleutian District of the BSAI. The opening is effective 1200 hrs, A.l.t., April 18, 2008, through 2400 hours, December 31, 2008. Classification This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA,
(AA)finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such a requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the opening of the Pacific ocean perch fishery in the Eastern Aleutian District of the BSAI for vessels participating in the BSAI trawl limited access fishery. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet and processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of April 17, 2008. The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment. Without this inseason adjustment, NMFS could not allow the Pacific ocean perch fishery in the Eastern Aleutian District of the BSAI for vessels participating in the BSAI trawl limited access fishery to be harvested in an expedient manner and in accordance with the regulatory schedule. Under § 679.25(c)(2), interested persons are invited to submit written comments on this action to the above address until May 5, 2008. This action is required by § 679.20 and § 679.25 and is exempt from review under Executive Order 12866. Authority: 16 U.S.C. 1801 *et seq.* Dated: April 17, 2008. William D. Chappell Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. 08-1173 Filed 4-18-08; 1:37 pm]
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- May I address the unsafe condition in a way other than that set out in the airworthiness directive?§ 39.19
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51 references not yet in our index
- 7 CFR 246
- 7 CFR 246.16
- 7 CFR 246.10
- 5 USC 601-612
- Pub. L. 104-4
- 7 CFR 3015
- 7 CFR 246.8(a)
- 7 CFR 246.8
- 5 CFR 1320
- 7 CFR 246.14(b)(1)(i)
- 7 CFR 246.18(a)(1)(ii)
- 7 CFR 246.12(l)(1)(ix)
- 7 CFR 246.18(a)(1)(i)
- 7 CFR 246.26(e)
- 7 CFR 246.26(e)(2)
- 7 CFR 246.26(e)(1)
- 7 CFR 246.26(e)(4)
- 14 CFR 39
- 14 CFR 71
- 18 CFR 39
- Pub. L. 109-58
- 119 Stat. 594
- 353 F.3d 71
- 21 CFR 556
- 21 CFR 20
- 5 USC 801-808
- 21 CFR 522
- 30 CFR 946
- 33 CFR 100
- 40 CFR 63
- 40 CFR 2
- 70 CFR 69210
- 40 CFR 9
- Pub. L. 104-113
- 40 CFR 60
- 40 CFR 180
- 40 CFR 178
- 40 CFR 180.601
- 40 CFR 166
- 40 CFR 271
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