2018 – Federal Register Recent Federal Regulation Documents

The Comprehensive Environmental Response, Compensation, and Liability Act (``CERCLA'' or ``the Act''), as amended, requires that the National Oil and Hazardous Substances Pollution Contingency Plan (``NCP'') include a list of national priorities among the known releases or threatened releases of hazardous substances, pollutants or contaminants throughout the United States. The National Priorities List (``NPL'') constitutes this list. The NPL is intended primarily to guide the Environmental Protection Agency (``EPA'' or ``the agency'') in determining which sites warrant further investigation. These further investigations will allow the EPA to assess the nature and extent of public health and environmental risks associated with the site and to determine what CERCLA-financed remedial action(s), if any, may be appropriate. This rule proposes to add six sites to the General Superfund section of the NPL and proposes to change the name of a site previously added to the NPL.

The Food and Drug Administration (FDA, Agency, or we) is proposing to amend requirements for medical device premarket submissions to remove paper and multiple copies and replace them with requirements for a single submission in electronic format. If finalized, this action would reduce the number of copies in electronic format required, thus improving and making more efficient the FDA's premarket submission program for medical devices. This action is part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations.

The Environmental Protection Agency (EPA) is taking direct final action to amend the EPA Acquisition Regulation (EPAAR). The clause pertaining to ``Release of Contractor Confidential Business'' is updated to incorporate the existing class deviation and make a minor addition. The ``Submission of Invoices'' clause is revised to incorporate the existing class deviation and updated with minor administrative edits. The clause ``Authorized or Required by Statute'' is clarified regarding the applicability of written justification requirements for the exception for other than full and open competition.

We are superseding Airworthiness Directive (AD) 2016-13-06, which applied to certain Saab AB, Saab Aeronautics Model 340A (SAAB/ SF340A) and SAAB 340B airplanes. AD 2016-13-06 required a revision of the applicable airplane flight manual (AFM), repetitive inspections of the horizontal stabilizer de-icing boots, and applicable corrective actions. This AD continues to require a revision of the applicable AFM, repetitive inspections of the horizontal stabilizer de-icing boots, and applicable corrective actions. This AD also requires replacement of single stitched de-icing boots with improved double stitched boots, and re-identification of the modified horizontal stabilizer leading edge. This AD was prompted by reports of ruptured horizontal stabilizer de- icing boots. We are issuing this AD to address the unsafe condition on these products.

The Coast Guard is establishing a temporary safety zone for the navigable waters within 150-yards of the S99 Alford Street Bridge, at mile 1.4 on the Mystic River between Charlestown and Everett, Massachusetts from October 1, 2018 through April 30, 2019. The safety zone is necessary to protect personnel, vessels and the marine environment from potential hazards created during the emergency replacement of the steel grid deck on all four bascule spans of the S99 Alford Street Bridge. This temporary rule would prohibit vessels and persons from being in the safety zone unless authorized by the Captain of the Port Boston or a designated representative.

We propose to supersede Airworthiness Directive (AD) 97-26-03 for Eurocopter Deutschland GmbH Model MBB-BK 117 A-1, MBB-BK 117 A-3, MBB-BK 117 A-4, MBB-BK 117 B-1, MBB-BK 117 B-2, and MBB-BK 117 C-1 helicopters. AD 97-26-03 requires visual inspections for cracks in the ribbed area of the main rotor (M/R) mast flange (flange). Since we issued AD 97-26-03, we have determined that a certain reinforced M/R mast is not affected by the unsafe condition. This proposed AD would retain the requirements of AD 97-26-03 and would remove a certain M/R mast from the applicability. The actions of this proposed AD are intended to address an unsafe condition on these products.

We propose to supersede Airworthiness Directive (AD) 2012-25- 02, which applies to certain Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. AD 2012-25-02 requires revising the airworthiness limitations section (AWL) of the instructions for continued airworthiness (ICA) of the maintenance requirements manual by incorporating new procedures for repetitive inspections for cracking of the rear pressure bulkhead (RPB). AD 2012- 25-02 also requires revising the maintenance program to incorporate a revised task which requires an improved non-destructive inspection procedure. Since we issued AD 2012-25-02, additional in-service crack findings resulted in the development of a structural modification to the RPB. This proposed AD would mandate modification of the RPB and would add repetitive inspections for cracking of the RPB web, which would terminate certain actions in this proposed AD. We are proposing this AD to address the unsafe condition on these products.

This action proposes to modify Class E airspace extending upward from 1,200 feet above the surface at Badami Airport, AK. This proposal would add exclusionary language to the legal description of the airport to ensure the safety and management of aircraft within the National Airspace System. Also, the geographic coordinates of the airport would be adjusted.

This action proposes to modify Class E airspace extending upward from 1,200 feet above the surface at Atqasuk Edward Burnell Sr. Memorial Airport, Atqasuk, AK. This proposal would add exclusionary language to the legal description of the airport to ensure the safety and management of aircraft within the National Airspace System. Also, the geographic coordinates of the airport would be adjusted.

This action establishes Class E airspace extending upward from 700 feet above the surface, at Washington Island Airport, Washington Island, WI. Controlled airspace is necessary to accommodate new standard instrument approach procedures developed at Washington Island Airport, for the safety and management of instrument flight rules (IFR) operations.

NMFS proposes to reclassify certain management unit species in the Pacific Islands as ecosystem component species. The proposed rule would also update the scientific and local names of certain species. The intent of this proposed rule is to prioritize conservation and management efforts and to improve efficiency of fishery management in the region.

We are adopting a new airworthiness directive (AD) for all Airbus Defense and Space S.A. Model CN-235, CN-235-100, CN-235-200, CN- 235-300, and C-295 airplanes. This AD was prompted by reports that cracks were found on the door mechanism actuator shaft assemblies of the nose landing gear (NLG). This AD requires repetitive inspections of the NLG door mechanism actuator shaft assemblies having certain part numbers, and corrective actions if necessary. This AD would also provide an optional terminating action for the repetitive inspections for Model CN-235, CN-235-100, CN-235-200, and CN-235-300 airplanes. We are issuing this AD to address the unsafe condition on these products.

The Department of Defense (DoD) proposes to revise its Privacy regulation to implement the Privacy Act of 1974, as amended. The rule will also implement changes which conform to the requirements of the Office of Management and Budget Circular A-108, December 23, 2016. This part establishes and promotes uniformity in the DoD Privacy Program, creating a single privacy rule for the Department, while incorporating other administrative changes. It would take precedence over all DoD component publications that supplement and implement the DoD Privacy program. DoD plans to remove individual component rulemakings in this area as subsequent actions.

The Environmental Protection Agency (EPA) Region 1 announces the deletion of the Old Southington Landfill Superfund Site (Site) located in Southington, Connecticut, 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 of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the State of Connecticut, through the Connecticut Department of Energy and Environmental Protection (CTDEEP), have determined that all appropriate response actions under CERCLA, other than operation and maintenance, monitoring, and five-year reviews, have been completed. However, this deletion does not preclude future actions under Superfund.

The Food and Drug Administration (FDA, the Agency, or we) is removing instruction 13 from the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Preventive Controls for Human Food) regulation. Instruction 13 directs the Federal Register to remove and reserve as of September 17, 2018, the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (Human Food CGMP) regulation. Removal of instruction 13 is necessary because the compliance dates for certain facilities subject to the modernized current good manufacturing practice requirements in the Preventive Controls for Human Food regulation have been extended. Retaining the Human Food CGMP regulation will maintain the status quo while these facilities prepare for compliance with the new CGMP requirements and will avoid an unintended gap in public health protection.

This rule implements a recommendation to establish a grower allotment percentage for the 2018-19 crop year and allows for the diversion of processed products from that year under the marketing order for cranberries grown in the production area (Order). This action also specifies handlers subject to the regulation, revises the definition of outlets for excess fruit, revises dates by which certain actions are due, and establishes exemptions to the action.

The New Mexico Environment Department (NMED) has submitted updated regulations for receiving delegation and approval of a program for the implementation and enforcement of certain New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAP) for all sources (both Title V and non-Title V sources). These updated regulations apply to certain NSPS promulgated by the EPA and amended between September 24, 2013 and January 15, 2017; certain NESHAP promulgated by the EPA and amended between January 1, 2011 and January 15, 2017; and other NESHAP promulgated by the EPA and amended between August 30, 2013 and January 15, 2017, as adopted by the NMED. The delegation of authority under this action does not apply to sources located in Bernalillo County, New Mexico, or to sources located in areas defined as Indian Country. The EPA is providing notice that it is updating the delegation of certain NSPS to NMED, and taking final action to approve the delegation of certain NESHAP to NMED.

These amended special conditions are issued for the Boeing Model 777 series airplanes. This amendment states that the Boeing Model 777 series airplanes oblique (side-facing) seats may be installed at an angle of 18 to 45 degrees to the airplane centerline and may include a 3-point or airbag restraint system, or both, for occupant restraint and injury protection. This airplane will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. These design features are oblique (side-facing) single-occupant passenger seats equipped with or without airbag devices or 3-point restraints. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

The Environmental Protection Agency (also, ``the Agency'' or ``we'' in this preamble) is proposing to grant a petition submitted by Sandvik Special Metals (Sandvik), in Kennewick, Washington to exclude (or ``delist'') up to 1,500 cubic yards of F006 wastewater treatment sludge per year from the list of federal hazardous wastes. The Agency is proposing to grant the petition based on an evaluation of waste-specific information provided by Sandvik. This proposed decision, if finalized, conditionally excludes the petitioned waste from the requirements of hazardous waste regulations under the Resource Conservation and Recovery Act. We conclude that Sandvik's petitioned waste is nonhazardous with respect to the original federal listing criteria and that there are no other factors (including additional constituents) other than those for which the waste was listed that would warrant retaining the waste as a hazardous waste. Subject to state-only requirements within the state of Washington, or federally-authorized or state-only requirements in other states where the subject wastes may be disposed of, Sandvik's petitioned waste may be disposed of in a Subtitle D landfill which is permitted, licensed, or registered by a State to manage industrial solid waste.

The Environmental Protection Agency (EPA) is proposing the results of the residual risk and technology reviews (RTR) for three rulesthe National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Surface Coating of Large Appliances; the NESHAP for the Printing, Coating, and Dyeing of Fabrics and Other Textiles; and the NESHAP for the Surface Coating of Metal Furniture. The EPA is proposing to find the risks due to emissions of air toxics from these source categories under the current standards to be acceptable and that the standards provide an ample margin of safety to protect public health. We are proposing no revisions to the numerical emission limits based on these risk analyses or technology reviews. The EPA is proposing no new requirements based on the technology review of the NESHAP for the Printing, Coating, and Dyeing of Fabrics and Other Textiles. The EPA is proposing to require the use of high efficiency spray application equipment under the technology review for the two rules that employ the use of coating spray application, the NESHAP for the Surface Coating of Large Appliances and the NESHAP for the Surface Coating of Metal Furniture, if the source is not using the emission rate with add-on control compliance option. The EPA is also requesting comment on whether the high efficiency spray equipment technology requirement under the technology review is necessary in light of the risk analyses indicating that there are ample margins of safety. The EPA also is proposing to amend provisions addressing emissions during periods of startup, shutdown, and malfunction; to amend provisions regarding electronic reporting of performance test results; and to make miscellaneous clarifying and technical corrections.

This regulation establishes an exemption from the requirement of a tolerance for residues of 2-propenoic acid, 2-methyl-, 2- oxiranylmethyl ester, polymer with butyl 2-propenoate, ethenylbenzene and 2-ethylhexyl 2-propenoate; when used as an inert ingredient in a pesticide chemical formulation. Spring Trading Company on behalf of BASF Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 2-propenoic acid, 2-methyl-, 2-oxiranylmethyl ester, polymer with butyl 2-propenoate, ethenylbenzene and 2-ethylhexyl 2-propenoate on food or feed commodities.

NMFS announces that the U.S. purse seine fishery on the high seas in the area of application of the Convention on the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (Convention) between the latitudes of 20[deg] N and 20[deg] S will close as a result of reaching the 2018 limit on purse seine fishing effort in that area. This action is necessary for the United States to implement provisions of a conservation and management measure adopted by the Commission for the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (WCPFC or Commission) and to satisfy the obligations of the United States under the Convention, to which it is a Contracting Party.

On March 8, 2018, President Trump issued Proclamations 9704 and 9705 (referred to henceforth as the ``Proclamations''), imposing duties on imports of aluminum and steel. The Proclamations also authorized the Secretary of Commerce (referred to henceforth as the ``Secretary'') to grant exclusions from the duties if the Secretary determines the steel or aluminum article for which the exclusion is requested is not ``produced in the United States in a sufficient and reasonably available amount or of a satisfactory quality'' or should be excluded ``based upon specific national security considerations.'' On March 19, 2018, the Department issued an interim final rule (referred to henceforth as the ``March 19 rule''), setting forth the requirements a directly affected party located in the United States must satisfy when submitting exclusion requests. The March 19 rule also set forth the requirements that U.S. parties must meet when submitting objections to exclusion requests. The March 19 rule amended the National Security Industrial Base Regulations to add two new supplements. The rule published today by BIS, on behalf of the Secretary, revises the two supplements added by the March 19 rule. The revisions are informed by the comments received in response to the March 19 rule and the U.S. Department of Commerce's (referred to henceforth as ``the Department'') experience with managing the exclusion and objection process. The Department understands the importance of having a transparent, fair and efficient exclusion and objection process. The publication of today's rule should make significant improvements in all three respects, but due to the scope of this new process, BIS is publishing today's rule as an interim final rule with request for comments.

On July 17, 2018, the Agencies published in the Federal Register a notice of proposed rulemaking (proposal) that would amend the regulations implementing section 13 of the Bank Holding Company Act. Section 13 contains certain restrictions on the ability of a banking entity and nonbank financial company supervised by the Board to engage in proprietary trading and have certain interests in, or relationships with, a hedge fund or private equity fund. The proposed amendments are intended to provide banking entities with clarity about what activities are prohibited and to improve supervision and implementation of section 13. In response to requests from commenters regarding issues addressed in the proposal, the public comment period has been extended for 30 days until October 17, 2018. This action will allow interested persons additional time to analyze the proposal and prepare their comments.

The EPA is approving the redesignation request and limited maintenance plan for the PM10 National Ambient Air Quality Standard developed for the City of Pinehurst PM10 Nonattainment Area and the Pinehurst PM10 Expansion Nonattainment Area. This redesignation will change the status of both areas from nonattainment to attainment. The limited maintenance plan for these contiguous nonattainment areas addresses maintenance of the PM10 standard for a ten-year period beyond redesignation. Related to this action, the EPA is taking final agency action on the September 15, 2013, high wind exceptional event at the Pinehurst monitoring station. Additionally, the EPA is finalizing approval of the emissions inventory for the West Silver Valley 2012 annual PM2.5 nonattainment area.