October 2012 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for four ophthalmic ointments, a change of sponsor's name, and a change of sponsor's address.

The U.S. Environmental Protection Agency Region 5 is publishing a Direct Final Notice of Deletion of the Isle Royale Tailings and Michigan Smelter Tailing parcels of Operable Unit 3 (OU3), and the Mason Sands Tailings parcel of Operable Unit 1 (OU1) of the Torch Lake Superfund Site (Site), located in Houghton County, Michigan from the National Priorities List (NPL). The NPL, promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix to the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). This direct final partial deletion is being published by EPA, with the concurrence of the State of Michigan through the Michigan Department of Environmental Quality (MDEQ), because EPA has determined that all appropriate response actions under CERCLA at these identified parcels have been completed. However, this partial deletion does not preclude future actions under Superfund. This partial deletion pertains to the surface tailings, drums, and slag piles of Isle Royale Tailings and Michigan Smelter Tailings parcels of OU3 and the Mason Sands Tailings parcel of OU1. The following land parcels will remain on the NPL and are not being considered for deletion as part of this action: Dollar Bay, Point Mills, Calumet Lake Tailing, Boston Pond Tailing, North Entry and Quincy Smelter.

The Audio Division, at the request of Sound Enterprises, substitutes Channel 275A for vacant Channel 271A at Randsburg, California to accommodate the hybrid contingent application for Station KSSI (FM), requesting to upgrade the facilities of the FM station from Channel 274A to Channel 271B1 at China Lake, California. A staff engineering analysis determines that Channel 275A can be allotted to Randsburg consistent with the minimum distance separation requirements of the Rules with a site restriction 0.04 kilometers (0.03 miles) southeast of the community. The reference coordinates for Channel 275A at Randsburg are 35-22-06 NL and 117-39-25 WL.

We are adopting a new airworthiness directive (AD) for Agusta S.p.A. (Agusta) Model A109S helicopters to require modifying the electrical power distribution system to carry a higher electrical load. This AD was prompted by an electrical failure on an Agusta Model A109E helicopter that resulted from ``inadequate functioning of the 35 amperes (amps) BATT BUS circuit breaker.'' The actions of this AD are intended to require modifying the electrical power distribution system to prevent failure of the circuit breaker, loss of electrical power to instruments powered by the ``BATT BUS'' system, and subsequent loss of control of the helicopter.

GSA is proposing to amend the Federal Travel Regulation (FTR) by removing the conference lodging allowance reimbursement option for employees on temporary duty (TDY) travel.

We are adopting a new airworthiness directive (AD) for all Airbus Model A300 series airplanes; Model A310 series airplanes; and Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes). This AD was prompted by reports of cracked fuel pump canister hoods located in fuel tanks. This AD requires replacing any cracked hood halves of fuel pump canisters. We are issuing this AD to prevent any detached canister hood fragments/debris from being ingested into the fuel feed system, and becoming a potential source of ignition with consequent fire or explosion.

We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 767-200, -300, -300F, and -400ER series airplanes. This AD was prompted by a design review following a ground fire incident and reports of flammable fluid leaks from the wing leading edge area onto the engine exhaust area. This AD requires modification of the fluid drain path in the leading edge area of the wing. We are issuing this AD to prevent flammable fluid from leaking onto the engine exhaust nozzle, which could result in a fire.

EPA is approving a revision to the North Dakota State Implementation Plan (SIP) relating to regulation of Greenhouse Gases (GHGs) and fine particulate matter (PM2.5) under North Dakota's Prevention of Significant Deterioration (PSD) program. This revision was submitted by the North Dakota Department of Health Division of Air Quality (ND DOH DAQ) to EPA on April 18, 2011. It is intended to align North Dakota's regulations with the ``PSD and Title V Greenhouse Gas Tailoring Final Rule'' and the final rule for ``Implementation of the New Source Review (NSR) Program for PM2.5.'' EPA is approving the revision because the Agency has determined that the SIP revision, already adopted by North Dakota as a final effective rule, is in accordance with the Clean Air Act (CAA or Act) and EPA regulations regarding PSD permitting for GHGs and PM2.5.

EPA is approving in part and disapproving in part State Implementation Plan (SIP) revisions submitted by the state of Nevada pursuant to the requirements of the Clean Air Act (CAA) for the 1997 8- hour ozone national ambient air quality standards (NAAQS) and the 1997 and 2006 NAAQS for fine particulate matter (PM2.5). The CAA requires that each State adopt and submit a SIP for the implementation, maintenance, and enforcement of each NAAQS promulgated by the EPA, and requires EPA to act on such SIPs. Nevada has met most of the applicable requirements. Where EPA is disapproving, in part, Nevada's SIP revisions, the majority of the deficiencies have been already been addressed by a federal implementation plan (FIP). For one remaining deficiency, this final rule sets a two-year deadline for EPA to promulgate a FIP, unless EPA approves an adequate SIP revision prior to that time. EPA remains committed to working with Nevada's environmental agencies to develop such a SIP revision.

We are adopting a new airworthiness directive (AD) to supersede an existing airworthiness directive for MD Helicopters, Inc. (MDHI), Model MD900 helicopters. The existing AD requires a visual inspection, and if necessary, an eddy current inspection of the main rotor lower hub assembly (lower hub) for a crack. If a crack exists, the AD requires replacing the lower hub with an airworthy lower hub before further flight. Because that AD was immediately effective, we declined to require certain long-term actions prior to public comment. This superseding AD will require the same inspections as the existing AD but will also require long-term recurring inspections and replacing the lower hub with an airworthy lower hub. We are issuing this AD to detect a crack in the lower hub and prevent failure of the lower hub and subsequent loss of control of the helicopter.

The Coast Guard is establishing a temporary safety zone for a portion of the Mobile River, Mobile, AL in the vicinity of Cooper Riverside Park. This action is necessary for the protection of persons and vessels on navigable waters during the Cooper T. Smith Fireworks Event. Entry into, transiting or anchoring in this zone is prohibited to all vessels, mariners, and persons unless specifically authorized by the Captain of the Port Mobile or a designated representative.

GSA has adopted as final, an interim rule amending the Federal Travel Regulation (FTR) by changing, updating, and clarifying various provisions regarding temporary duty (TDY) travel. These changes include adjusting the definition of incidental expenses; clarifying necessary deduction amounts from the meals and incidental expense (M&IE) reimbursement on travel days; extending agencies the authority to issue blanket actual expense approval for TDY travel during Presidentially- Declared Disasters; and updating other miscellaneous provisions.

We are revising an earlier NPRM for all PILATUS AIRCRAFT LTD. Models PC-12, PC-12/45, PC-12/47, and PC-12/47E airplanes. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as a need to incorporate new revisions into the Limitations section, Chapter 4, of the FAA-approved maintenance program (e.g., maintenance manual). We are issuing this proposed AD to require actions to address the unsafe condition on these products.

We propose to adopt a new airworthiness directive (AD) for Burkhart GROB Luft-und Raumfahrt GmbH Models GROB G 109 and GROB G 109B sailplanes. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as corrosion and/or cracking of the elevator control rod that could lead to failure of the elevator control rod with consequent loss of control. We are issuing this proposed AD to require actions to address the unsafe condition on these products.

The Pipeline and Hazardous Materials Safety Administration is proposing to amend the Hazardous Materials Regulations to incorporate provisions contained in certain widely used or longstanding special permits and certain competent authority approvals (``approvals'') that have established safety records. Special permits allow a company or individual to package or ship a hazardous material in a manner that varies from the regulations provided an equivalent level of safety is maintained. An approval is a written consent (document) required under an international standard (i.e., International Maritime Dangerous Goods (IMDG) Code, International Civil Aviation Organization (ICAO)), or is specifically provided for in the HMR, and is issued by the Associate Administrator for Hazardous Materials Safety. These proposed revisions are intended to provide wider access to the regulatory flexibility offered in special permits and approvals and eliminate the need for numerous renewal requests, reducing paperwork burdens and facilitating commerce while maintaining an appropriate level of safety. Additionally, this rulemaking will address three petitions for rulemaking regarding the continued use of renewal applications for long standing special permits.

EPA is proposing to approve into the Illinois State Implementation Plan (SIP) an adjusted standard for the Greif Packaging, LLC facility located at 5 S 220 Frontenac Road in Naperville, Illinois (Greif). On June 20, 2012, the Illinois Environmental Protection Agency submitted to EPA for approval an adjustment to the general rule, Organic Material Emission Standards and Limitations for the Chicago Area; Subpart TT: Other Emission Units, as it applies to emissions of volatile organic matter (VOM) from Greif's fiber drum container manufacturing facility. VOM, as defined by the State of Illinois, is identical to volatile organic compound, as defined by EPA. The adjusted standard replaces portions of the general rule for VOM emissions with site-specific reasonably available control technology requirements for the Greif facility.

EPA is finalizing approval of revisions to the San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD) portion of the California State Implementation Plan (SIP). This action was proposed in the Federal Register on June 13, 2012 and concerns volatile organic compound (VOC) emissions from crude oil production sumps and refinery wastewater separators. We are approving local rules that regulate these emission sources under the Clean Air Act (CAA or the Act).

EPA is promulgating a Federal Implementation Plan (FIP) to address regional haze in the Territory of the United States Virgin Islands. EPA determined that the FIP meets the requirements of the Clean Air Act and EPA's rules concerning reasonable progress towards the national goal of preventing any future and remedying any existing man-made impairment of visibility in mandatory Class I areas (also referred to as the ``regional haze program''). The FIP protects and improves visibility levels in the Virgin Islands Class I area, namely the Virgin Islands National Park on the island of St. John. The FIP for the Virgin Islands addresses reasonable progress toward improving visibility and evaluation of Best Available Retrofit Technology.

The Department of the Treasury's Office of Foreign Assets Control (``OFAC'') is changing the heading of the Iranian Transactions Regulations to the Iranian Transactions and Sanctions Regulations (the ``ITSR''), amending the renamed ITSR, and reissuing them in their entirety, to implement Executive Order 13599 of February 5, 2012 (``Blocking Property of the Government of Iran and Iranian Financial Institutions''), and subsections 1245(c) and (d)(1)(B) of the National Defense Authorization Act for Fiscal Year 2012 (the ``NDAA''). OFAC also is adding several new general licenses to the ITSR, removing a few general licenses, and incorporating into the ITSR a general license and a statement of licensing policy that, until now, have appeared only on OFAC's Web site on the Iran sanctions page. Finally, OFAC is updating certain provisions of the ITSR and making other technical and conforming changes. The ITSR are separate and apart from the Iranian Financial Sanctions Regulations, 31 CFR part 561, as amended and reissued in their entirety on February 27, 2012, which were promulgated to implement the Comprehensive Iran Sanctions, Accountability, and Divestment Act of 2010, as well as the provisions of section 1245 of the NDAA other than those set forth above.

NMFS proposes to implement management measures described in Amendment 38 to the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico (FMP) prepared by the Gulf of Mexico (Gulf) Fishery Management Council (Council). If implemented, this rule would modify post-season accountability measures (AMs) that affect shallow- water grouper species (SWG), change the trigger for AMs, and revise the Gulf reef fish framework procedure. The intent of this proposed rule is to achieve optimum yield (OY) while ensuring the fishery resources are utilized efficiently.

NMFS proposes to modify the regulations implementing the Northeast (NE) Multispecies Fishery Management Plan (FMP) to allow vessels to fish with gillnet and longline gear from June through December, and with handline gear from June through August, in a portion of inshore Georges Bank (GB) each year, outside of the requirements of the NE multispecies fishery. This action would allow vessels to harvest spiny dogfish and other non-groundfish species in a manner that is consistent with the bycatch reduction objectives of the FMP.

NMFS announces that the 2012 summer flounder commercial quota allocated to the State of New York has been harvested. Vessels issued a commercial Federal fisheries permit for the summer flounder fishery may not land summer flounder in New York for the remainder of calendar year 2012, unless additional quota becomes available through a transfer from another state. Regulations governing the summer flounder fishery require publication of this notification to advise New York that the quota has been harvested and to advise vessel permit holders and dealer permit holders that no Federal commercial quota is available for landing summer flounder in New York.

NMFS is prohibiting directed fishing for pollock in Statistical Area 610 in the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2012 total allowable catch of pollock for Statistical Area 610 in the GOA.

We, the U.S. Fish and Wildlife Service (Service), propose to revise designation of critical habitat for the Comal Springs dryopid beetle (Stygoparnus comalensis), Comal Springs riffle beetle (Heterelmis comalensis), and Peck's cave amphipod (Stygobromus pecki), under the Endangered Species Act of 1973, as amended (Act). In total, approximately 169 acres (68 hectares) are being proposed for revised critical habitat. The proposed revision of critical habitat is located in Comal and Hays Counties, Texas.

The EPA is proposing to revise the deadlines established in the national ambient air quality standard (NAAQS) for nitrogen dioxide (NO2) for the near-road component of the NO2 monitoring network and to implement a phased deployment approach. This approach would create a series of deadlines that would make the near- road NO2 network operational between January 1, 2014, and January 1, 2017. The EPA is also proposing to revise the approval authority for annual monitoring network plans for NO2 monitoring.