January 2020 – Federal Register Recent Federal Regulation Documents

The Environmental Protection Agency (EPA) Region 8 is issuing a Notice of Intent to Delete Operable Unit 1 (OU1), Former Export Plant, of the Libby Asbestos Superfund Site (Site), located in Lincoln County, Montana, from the National Priorities List (NPL) and requests public comments on this proposed action. The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the State of Montana (State), through the Department of Environmental Quality (DEQ), have determined that all appropriate response actions at OU1 under CERCLA, other than operation and maintenance and five-year reviews (FYR), have been completed. However, this partial deletion does not preclude future actions under Superfund. This partial deletion pertains only to OU1. Operable Unit 2 (OU2), Former Screening Plant, was deleted from the NPL on April 10, 2019. Operable Unit 3 (OU3), Former Vermiculite Mine; Operable Unit 4 and Operable Unit 7 (OU4/OU7), Residential/Commercial Properties of Libby and Troy; Operable Unit 5 (OU5), Former Stimson Lumber Mill; Operable Unit 6 (OU6), BNSF Rail Corridor; and Operable Unit 8 (OU8), Highways and Roadways, are not being considered for deletion as part of this proposed action and will remain on the NPL.

The U.S. Vessel Monitoring System (VMS) program type-approves enhanced mobile transceiver units (EMTUs) for use in U.S. fisheries. Currently, the only approved method for transferring VMS data from a vessel to NMFS is by satellite-linked communication services. This proposed rule would amend the existing VMS type-approval regulations to add cellular-based EMTUs (EMTU-Cs) type-approval application and testing procedures; compliance and revocation processes; and technical, service, and performance standards. This proposed rule is necessary to allow for the use of EMTU-Cs and cellular communication service, in addition to satellite-only models, in federally managed fisheries.

The Drug Enforcement Administration places methyl 2-(1-(5- fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoat e [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1H-indazole-3- carboxamido)-3-methylbutanoate [5F-AMB]; N-(adamantan-1-yl)-1-(5- fluoropentyl)-1H-indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1- amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-ind azole-3- carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1H-indole-3- carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA]; and methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3- dimethylbutanoate [MDMB-FUBINACA], including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act. This action continues the imposition of the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle 5F- ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA.

This final rule adopts a modification of the requirements for the use of the Telecommunication Standard Implementation Guide, Version D, Release 0 (Version D.0), August 2007, National Council for Prescription Drug Programs, by requiring covered entities to use the Quantity Prescribed (460-ET) field for retail pharmacy transactions for Schedule II drugs. The modification enables covered entities to distinguish whether a prescription is a ``partial fill,'' where less than the full amount prescribed is dispensed, or a refill, where the full amount prescribed is dispensed, in the HIPAA retail pharmacy transactions. This modification is important to ensure the availability of a greater quantum of data that may help prevent impermissible refills of Schedule II drugs, which will help to address the public health concerns associated with prescription drug abuse in the United States.

The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) submission from the Illinois Environmental Protection Agency (IEPA) dated May 16, 2019. The submission provides IEPA's certification that its existing emissions statement program, titled ``Annual Emissions Report'', remains in effect and satisfies the Clean Air Act (CAA) emissions statement requirement for the Illinois portions of the Chicago, Illinois-Indiana-Wisconsin (IL-IN-WI) and St. Louis, Missouri-Illinois (MO-IL) nonattainment areas under the 2015 ozone National Ambient Air Quality Standard (NAAQS). Under the CAA, states' SIPs must require stationary sources in ozone nonattainment areas classified as marginal or above to annually report emissions of Volatile Organic Compounds (VOC) and Oxides of Nitrogen (NOX).

The Environmental Protection Agency (EPA) is taking final action to approve a revision to the State Implementation Plan (SIP) for the State of Missouri submitted by the State on October 25, 2019. The revisions will amend the SIP by providing a more efficient way to perform emissions sampling on air pollution sources throughout Missouri. The State requested approval of incorporating by reference the federally defined methods for stack testing. These revisions are administrative in nature and do not affect the stringency of the SIP. The EPA's approval of this rule revision is being done in accordance with the requirements of the Clean Air Act (CAA).

The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and two abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.

The Securities and Exchange Commission (the ``Commission'') is re-proposing rule 18f-4, a new exemptive rule under the Investment Company Act of 1940 (the ``Investment Company Act'') designed to address the investor protection purposes and concerns underlying section 18 of the Act and to provide an updated and more comprehensive approach to the regulation of funds' use of derivatives and the other transactions addressed in the proposed rule. The Commission is also proposing new rule 15l-2 under the Securities Exchange Act of 1934 (the ``Exchange Act'') and new rule 211(h)-1 under the Investment Advisers Act of 1940 (``Advisers Act'') (collectively, the ``sales practices rules''). In addition, the Commission is proposing new reporting requirements and amendments to Form N-PORT, Form N-LIQUID (which we propose to be re-titled as ``Form N-RN''), and Form N-CEN, which are designed to enhance the Commission's ability to effectively oversee funds' use of and compliance with the proposed rules, and for the Commission and the public to have greater insight into the impact that funds' use of derivatives would have on their portfolios. Finally, the Commission is proposing to amend rule 6c-11 under the Investment Company Act to allow certain leveraged/inverse ETFs that satisfy the rule's conditions to operate without the expense and delay of obtaining an exemptive order.

The FAA proposes to adopt a new airworthiness directive (AD) for all CFM International S.A. (CFM) LEAP-1B21, -1B23, -1B25, -1B27, - 1B28, -1B28B1, -1B28B2, -1B28B2C, -1B28B3, -1B28BBJ1, and -1B28BBJ2 model turbofan engines. This proposed AD was prompted by reports of two new unsafe conditions and the need to supersede corrective actions for two previously addressed unsafe conditions. The FAA proposes to supersede AD 2018-25-09 and AD 2019-12-01, which apply to the affected LEAP-1B model turbofan engines. Since the FAA issued the ADs, the FAA received information and analysis indicating that supersedure of these ADs is warranted.

The United States Copyright Office is issuing a supplemental interim rule amending its regulations governing recordation of transfers of copyright ownership, notices of termination, and other documents pertaining to a copyright. This rule supplements the Office's current interim recordation regulations in anticipation of the Office's forthcoming pilot program through which participating remitters will be able to record certain types of documents electronically online. The supplemental interim rule and pilot program are the next step in the recordation modernization process, which will lead to a full public release of the Office's electronic recordation system in the future.

The National Marine Fisheries Service (NMFS) publishes this proposed Annual Determination (AD) for 2020, pursuant to its authority under the Endangered Species Act (ESA). Through the AD, NMFS identifies U.S. fisheries operating in the Atlantic Ocean, Gulf of Mexico, and Pacific Ocean that will be required to take fisheries observers upon NMFS' request. The purpose of observing identified fisheries is to learn more about sea turtle interactions in a given fishery, evaluate measures to prevent or reduce sea turtle takes, and implement the prohibition against sea turtle takes. Fisheries identified on the 2020 AD (see Table 1) will remain on the AD for a five-year period from the effective date of the final rule and will be required to carry observers upon NMFS' request.

Notice is hereby given that the comment period for a proposed rule published in the Federal Register on December 17, 2019, is reopened. The document invited comments on draft instructions for validation of refining processes as it pertains to the National Bioengineered Food Disclosure Standard (Standard).

This action amends low altitude area navigation (RNAV) route T-217 in the vicinity of Springfield, OH, to update the facility type listed for the Springfield, OH (SGH), route point in the T-route description. The FAA is taking this action due to the planned decommissioning of the VHF Omnidirectional Range (VOR) portion of the Springfield VOR/Distance Measuring Equipment (VOR/DME) navigation aid (NAVAID). No existing route structure or air traffic services are affected by this action.

This action modifies 3 jet routes, 2 high altitude area navigation (RNAV) Q-routes, and 8 VHF Omnidirectional Range (VOR) Federal airways, and establishes 4 low altitude RNAV T-routes in the vicinity of Houston, TX. The FAA is taking this action due to the planned decommissioning of the Hobby, TX, VOR/Distance Measuring Equipment (VOR/DME) navigation aid (NAVAID), which provides navigation guidance for portions of the affected ATS routes.

This rulemaking proposes changes to simplify meal pattern and monitoring requirements in the National School Lunch and School Breakfast Programs. The proposed changes, including optional flexibilities, are customer-focused and intended to help State and local Program operators overcome operational challenges that limit their ability to manage these Programs efficiently. In the National School Lunch Program, the proposed rule would add flexibility to the existing vegetable subgroups requirement. In the School Breakfast Program, the proposed rule would make it easier for menu planners to offer meats/meat alternates and grains interchangeably (without offering a minimum grains requirement daily), and would allow schools to offer \1/2\ cup of fruit in breakfasts served outside the cafeteria to reduce food waste. Other proposed changes would make it easier for local Program operators to plan menus for different age/grade groups, and expand the entr[eacute]e exemption service timeframe for competitive foods. To improve efficiency in Program monitoring, the proposed rule also would ease several administrative review requirements, including the review cycle. The monitoring changes aim to decrease the burden associated with administrative reviews while rewarding program integrity initiatives at the State and local levels. This rule also proposes to make updates, clarifications, and technical corrections throughout other parts of its regulations. Implementation of the wide range of proposed changes and flexibilities is expected to simplify operational requirements, increase efficiency, and make it easier for State and local Program operators to feed children.

The Clean Air Act (CAA or the Act) requires each State Implementation Plan (SIP) to contain adequate provisions prohibiting emissions that will have certain adverse air quality effects in other states. On September 26, 2018, the State of Idaho made a submission to the Environmental Protection Agency (EPA) to address these requirements for the 2015 ozone National Ambient Air Quality Standards (NAAQS). The EPA is proposing to approve the submission as meeting the requirement that each SIP contain adequate provisions to prohibit emissions that will significantly contribute to nonattainment or interfere with maintenance of the 2015 ozone NAAQS in any other state.

The Farm Credit Administration (FCA, we, or our) proposes to repeal the regulatory requirement that production credit associations (PCAs) amortize their loans in 15 years or less, while requiring all Farm Credit System (FCS or System) associations to address amortization through their credit underwriting standards and internal controls.

The Department of State (the Department) amends the International Traffic in Arms Regulations (ITAR) to revise Categories Ifirearms, close assault weapons and combat shotguns, IIguns and armament, and IIIammunition/ordnance of the U.S. Munitions List (USML) to describe more precisely the articles that provide a critical military or intelligence advantage or, in the case of weapons, perform an inherently military function and thus warrant export and temporary import control on the USML. These revisions complete the initial review of the USML that the Department began in 2011. Items not subject to the ITAR or to the exclusive licensing jurisdiction of any other set of regulations are subject to the Export Administration Regulations.

This document contains final regulations that provide guidance applicable to transfers of appreciated property by U.S. persons to partnerships with foreign partners related to the transferor. Specifically, when a U.S. person transfers appreciated property to a partnership with a foreign partner related to the transferor, the regulations override the general nonrecognition rule unless the partnership adopts the remedial allocation method and certain other requirements are satisfied. The regulations affect U.S. partners in domestic or foreign partnerships.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Florida East Coast (FEC) Railroad Bridge across the New River, mile 2.5, at Fort Lauderdale, Florida. This deviation will test a change to the drawbridge operation schedule to determine if the proposed operating schedule changes will meet the reasonable needs of maritime traffic and railway traffic. This deviation will allow the drawbridge to operate a more predictable schedule.

The FAA proposes to adopt a new airworthiness directive (AD) for certain Bombardier, Inc., Model BD-100-1A10 airplanes. This proposed AD was prompted by a report of an in-flight event where a flightcrew observed a SPOILER FAIL message and had difficulty maintaining roll control of the airplane. This proposed AD would require revising the existing airplane flight manual (AFM) to provide the flightcrew with procedures related to roll spoiler failures that reduce the flightcrew workload during this type of failure scenario. The FAA is proposing this AD to address the unsafe condition on these products.

This document advises the public that we, the U.S. Fish and Wildlife Service, intends to gather information necessary to develop a proposed rule to expand management of double-crested cormorants (Phalacrocorax auritus) throughout the United States, and prepare a draft environmental review pursuant to the National Environmental Policy Act of 1969, as amended. We are furnishing this advance notice of proposed rulemaking to advise other agencies and the public of our intentions; obtain suggestions and information on the scope of issues to include in the environmental review; and announce public scoping webinars to occur in 2020.

We, the U.S. Fish and Wildlife Service (Service), propose to reclassify the humpback chub (Gila cypha) from an endangered species to a threatened species on the Federal List of Endangered and Threatened Wildlife, due to partial recovery. Based on the best available scientific and commercial data, threats to the humpback chub identified at the time of listing have been eliminated or reduced to the point that the species no longer meets the definition of an endangered species under the Endangered Species Act of 1973, as amended (Act), but is likely to become an endangered species within the foreseeable future. We also propose a rule issued under section 4(d) of the Act that is necessary and advisable to provide for the conservation of the humpback chub.

The Food and Drug Administration (FDA or we) is classifying the radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the radiological CADx software for lesions suspicious for cancer's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

The Environmental Protection Agency (EPA) is proposing to take action pursuant to section 110 of the Clean Air Act (CAA or Act) on State Implementation Plan (SIP) revisions submitted by the State of Utah on July 3, 2019, as supplemented on December 3, 2019, to satisfy certain regional haze requirements for the program's first implementation period. The EPA is proposing to approve the July 2019 SIP revision that provides an alternative to best available retrofit technology (BART) controls for nitrogen oxides (NOX) at the PacifiCorp Hunter and Huntington power plants. The EPA proposes to find that the Utah NOX BART Alternative for Hunter and Huntington would provide greater reasonable progress toward natural visibility conditions than BART, in accordance with the requirements of the CAA and the EPA's Regional Haze Rule (RHR). In conjunction with this proposed approval, we propose to withdraw the federal implementation plan (FIP) that addresses NOX BART for the Hunter and Huntington power plants. The EPA also proposes to approve the December 3, 2019 SIP supplement that would require reporting of all deviations from compliance with the applicable requirements under BART and the BART Alternative, including the emission limits for Hunter and Huntington.