October 9, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect conditional approval of an application for conditional approval of a new animal drug intended for a minor species filed by Schering-Plough Animal Health Corp. The application seeks conditional approval of the use of florfenicol by veterinary feed directive for the control of mortality in catfish due to columnaris disease associated with Flavobacterium columnare.

EPA is transferring the management of the polychlorinated biphenyl (PCB) cleanup program and most of the PCB disposal program from the Office of Prevention, Pesticides and Toxic Substances (OPPTS) to the Office of Solid Waste and Emergency Response (OSWER). This final rule is a rule of agency organization, procedure, or practice. It makes minor amendments to 40 CFR parts 750 and 761, to update certain titles, organization references, and mailing and website addresses so that required procedures for providing information and seeking approvals will be consistent with EPA's new internal organization for managing the PCB program. OPPTS currently manages the PCB program under the Toxic Substances Control Act (TSCA) and its regulations. OSWER is the office within EPA that manages most cleanup and disposal activities under the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act of 1976 (RCRA) and the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). After the administrative transfer is completed, OSWER will oversee most issues pertaining to PCB cleanup and disposal under TSCA, RCRA, and CERCLA, as appropriate; OPPTS will continue to oversee other issues pertaining to PCBs (e.g., issues pertaining to PCB use) under TSCA. The transfer of the management of the PCB cleanup and disposal program from OPPTS to OSWER will consolidate administration of cleanup and disposal activities within one office. The transfer will not make any substantive changes to the regulatory requirements or standards for PCB cleanup and disposal under TSCA.

We are adopting as a final rule, without change, an interim rule that amended the emerald ash borer regulations by adding Prince George's County, MD, to the list of areas quarantined because of emerald ash borer. The interim rule was necessary to prevent the artificial spread of the emerald ash borer from Prince George's County, MD, into noninfested areas of the United States. As a result of the interim rule, the interstate movement of regulated articles from that county is restricted.

EPA is amending a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) to include certain additional perfluoroalkyl sulfonate (PFAS) chemicals. EPA is amending the PFAS SNUR at 40 CFR 721.9582 by adding a new Table 3 which includes the PFAS chemicals currently on the public TSCA Inventory that are not already covered by the SNUR. This rule requires manufacturers, including importers, to notify EPA at least 90 days before commencing the manufacture or import of the PFAS chemicals listed in Table 3 of the regulatory text for the significant new uses described in this document on or after November 8, 2007. EPA believes that this action is appropriate because these chemical substances may be hazardous to human health and the environment. This required notice will provide EPA the opportunity to evaluate intended significant new uses and associated activities before they occur and, if necessary, to prohibit or limit those uses or activities.

The Commission will hold a public hearing to receive comments on proposed amendments to the Commission's Water Quality Regulations, Water Code and Comprehensive Plan to establish numeric values for existing water quality for the reach of the main stem Delaware River known as the ``Lower Delaware'' and on a permanent basis to assign this reach the SPW classification ``Significant Resource Waters'' (SRW). Since 2005, the Lower Delaware has carried the SRW classification on a temporary basis. Also proposed is language intended to clarify aspects of the SPW regulations that have been a source of confusion for some DRBC docket holders and applicants since the program was originally adopted in 1992 for point sources and in 1994 for non-point sources.

The Coast Guard is establishing a temporary safety zone for the Monthly Biscayne Bay Yacht Racing Association (BBYRA) Cruising Races, which will temporarily limit the movement of non-participant vessels in Biscayne Bay near Miami, FL. This temporary safety zone is intended to restrict vessels from entering the waters where the event will be held unless specifically authorized by the Captain of the Port, Miami, Florida or his designated representative. This regulation is needed to protect the safety of participants, marine spectators and recreational and professional mariner traffic.

We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on a petition to list the black-footed albatross (Phoebastria nigripes) as threatened or endangered under the Endangered Species Act of 1973, as amended (Act). We find that the petition presents substantial scientific or commercial information indicating that listing the black-footed albatross may be warranted. Therefore, with the publication of this notice, we are initiating a status review to determine if listing the species is warranted. To ensure that the review is comprehensive, we are soliciting data and other information regarding this species.

EPA is proposing to approve revisions to the South Carolina State Implementation Plan (SIP) submitted on August 14, 2007. These revisions will incorporate provisions related to the implementation of EPA's Clean Air Interstate Rule (CAIR), promulgated on May 12, 2005 and subsequently revised on April 28, 2006 and December 13, 2006, and the CAIR Federal Implementation Plans (FIPs) concerning sulfur dioxide (SO2), nitrogen oxides (NOX) annual, and NOX ozone season emissions for the State of South Carolina, promulgated on April 28, 2006 and subsequently revised December 13, 2006. EPA is not proposing to make any changes to the CAIR FIPs, but is amending, to the extent EPA approves South Carolina's SIP revisions, the appropriate appendices in the CAIR FIP trading rules simply to note that approval. On September 19, 2007, South Carolina requested that EPA only act on a portion of the August 14, 2007, submittal as an abbreviated SIP. Consequently, EPA is proposing to approve the abbreviated SIP revisions that address the methodology to be used to allocate annual and ozone season NOX allowances under the CAIR FIPs as well as opt-in provisions for the SO2, NOX annual, and NOX ozone season trading programs. South Carolina also requested that EPA approve compliance supplement pool provisions for the NOX annual trading program. In the Final Rules Section of this Federal Register, EPA is approving the State's SIP revision as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this rule, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period on this document. Any parties interested in commenting on this document should do so at this time.

EPA is taking final action to approve a revision to the Georgia State Implementation Plan (SIP) submitted on March 28, 2007. This revision addresses the requirements of EPA's Clean Air Interstate Rule (CAIR) promulgated on May 12, 2005, and subsequently revised on April 28, 2006, and December 13, 2006. EPA has determined that the SIP revision fully implements the CAIR requirements for Georgia. As a result of this action, EPA will also withdraw, through a separate rulemaking, the CAIR Federal Implementation Plans (FIPs) concerning sulfur dioxide (SO2), and nitrogen oxides (NOX annual) season emissions for Georgia. The CAIR FIPs for all States in the CAIR region were promulgated on April 28, 2006, and subsequently revised on December 13, 2006. CAIR requires States to reduce emissions of SO2 and NOX that significantly contribute to, and interfere with maintenance of, the National Ambient Air Quality Standards (NAAQS) for fine particulates (PM2.5) and/or ozone in any downwind state. CAIR establishes State budgets for SO2 and NOX and requires States to submit SIP revisions that implement these budgets in States that EPA concluded did contribute to nonattainment in downwind states. States have the flexibility to choose which control measures to adopt to achieve the budgets, including participating in the EPA-administered cap-and-trade programs. In the SIP revision that EPA is approving today, Georgia has met the CAIR requirements by electing to participate in the EPA-administered cap-and-trade programs addressing SO2 and NOX annual emissions.

EPA is approving a State Implementation Plan (SIP) revision submitted by the Commonwealth of Pennsylvania. The Pennsylvania Department of Environmental Protection (PADEP) is requesting that the Erie 8-hour ozone nonattainment area (``Erie Area'' or ``Area'') be redesignated as attainment for the 8-hour ozone ambient air quality standard (NAAQS). The Area is comprised of Erie County, Pennsylvania. EPA is approving the ozone redesignation request for the Erie Area. In conjunction with its redesignation request, PADEP submitted a SIP revision consisting of a maintenance plan for Erie Area that provides for continued attainment of the 8-hour ozone NAAQS for at least 10 years after redesignation. EPA is approving the 8-hour maintenance plan. PADEP also submitted a 2002 base year inventory for the Erie Area which EPA is approving. In addition, EPA is approving the adequacy determination for the motor vehicle emission budgets (MVEBs) that are identified in the Erie Area maintenance plan for purposes of transportation conformity, and is approving those MVEBs. EPA is approving the redesignation request, and the maintenance plan and the 2002 base year emissions inventory as revisions to the Pennsylvania SIP in accordance with the requirements of the Clean Air Act (CAA).

We, the U.S. Fish and Wildlife Service (Service) announce the reopening of the public comment period and the scheduling of one public hearing on the proposed critical habitat designation for the Sierra Nevada bighorn sheep (Ovis canadensis californiana) and proposed taxonomic revision under the Endangered Species Act of 1973, as amended (Act). This action will provide all interested parties with an additional opportunity to submit written comments on the proposed designation and taxonomic revision. Comments previously submitted need not be resubmitted as they have already been incorporated into the public record and will be fully considered in any final decision.

This document, together with a companion final rule; technical amendments; response to petitions; published in today's edition of the Federal Register, addresses issues raised in petitions received in response to a December 2004 final rule that updated the Federal motor vehicle safety standard on brake hoses, and a related petition for rulemaking. In that rule, we incorporated updated versions of substantive specifications of several Society of Automotive Engineers (SAE) Recommended Practices relating to hydraulic brake hoses, vacuum brake hoses, air brake hoses, plastic air brake tubing, and end fittings. In this NPRM, we respond to some issues raised in the petitions and propose a number of amendments to the brake hose rule in response to the petitions. In the companion document, we deny several of the petitions and also correct typographical errors in, and inadvertent omissions from, the December 20, 2004 final rule.

The Nuclear Regulatory Commission (NRC) is amending its regulations applicable to limited work authorizations (LWAs), which allow certain construction activities on production and utilization facilities to commence before a construction permit or combined license is issued. This final rule modifies the scope of activities that are considered construction for which a construction permit, combined license, or LWA is necessary, specifies the scope of construction activities that may be performed under an LWA, and changes the review and approval process for LWA requests. The NRC is adopting these changes to enhance the efficiency of its licensing and approval process for production and utilization facilities, including new nuclear power reactors.