June 2018 – Federal Register Recent Federal Regulation Documents

The Coast Guard is establishing a temporary safety zone in the Chicago Harbor, Chicago, IL near the Adler Planetarium on June 26, 2018. This action is necessary and intended to ensure safety of life on the navigable waters of the United States immediately prior to, during, and after a fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Lake Michigan.

The Coast Guard is establishing a temporary safety zone in the Captain of the Port Detroit Zone on the Maumee River in the vicinity of Toledo, Ohio. This Zone is intended to restrict vessels from portions of the Maumee River for the Thunder over Toledo Fireworks Display. Persons and vessels are prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port Detroit, or his designated representative. This temporary safety zone is necessary to protect spectators and vessels from the hazards associated with fireworks displays.

We are amending the fruit and vegetable regulations to allow the importation of tree tomatoes from Ecuador into the continental United States. As a condition of entry, the tree tomatoes must be produced in accordance with a systems approach that includes requirements for importation in commercial consignments, registration and monitoring of places of production, field monitoring and pest control practices, trapping, and inspection for quarantine pests by the national plant protection organization of Ecuador. This action will allow the importation of tree tomatoes from Ecuador while continuing to protect against the introduction of plant pests into the United States.

The Food and Drug Administration (FDA or the Agency) is issuing this proposed order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection as postamendments class III (premarket approval) devices (regulated under product code MYN), into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. These devices are intended to direct the clinician's attention to portions of an image that may reveal abnormalities during interpretation of patient's radiology images by the clinician. If finalized, this order will reclassify these types of devices from class III to class II and reduce regulatory burdens on industry as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a less burdensome premarket notification (510(k)) before marketing their device.

The Bureau of Industry and Security (BIS) publishes this final rule to make certain conforming changes based on the revisions to Export Control Classification Number (ECCN) 1C350 on the Commerce Control List (CCL) contained in a final rule published on April 2, 2018. That final rule amended the Export Administration Regulations (EAR) to implement the recommendations presented at the February 2017 Australia Group (AG) Intersessional Implementation Meeting, and later adopted pursuant to the AG silent approval procedure, and the recommendations made at the June 2017 AG Plenary Implementation Meeting and adopted by the AG Plenary. Among other changes, the April 2, 2018, final rule amended ECCN 1C350 by renumbering paragraphs .b through .d in alphabetical order. Following the publication of that rule, however, certain references to ECCN 1C350.c and 1C350.d in the description of items eligible under the validated end-user authorization (VEU) provisions of the EAR no longer identified the correct subparagraphs in ECCN 1C350 because the rule inadvertently failed to update the references to ECCN 1C350.c and 1C350.d in the description of eligible items for three of the validated end-users identified in Supplement No. 7 to part 748 (Authorization Validated End-User (VEU)) of the EAR. This final rule amends the VEU provisions to provide the correct references to eligible items in ECCN 1C350 for three validated end-users.

The Coast Guard is establishing a temporary safety zone for navigable waters within a 300-foot radius of the launch site located at Presque Isle Bay, Erie, PA. This safety zone is intended to restrict vessels from portions of the Presque Isle Bay during the Flagship Niagara's Mariners Ball fireworks display. This temporary safety zone is necessary to protect mariners and vessels from the navigational hazards associated with a fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Buffalo.

This action corrects a final rule published in the Federal Register on May 17, 2018, amending Class D and Class E airspace at Greenwood, MS, by removing duplicative language added in the legal description of Class E airspace extending upward from 700 feet or more above the surface for Greenwood-Leflore Airport.

This rule establishes initial air quality designations for certain areas in the United States, including areas of Indian country, for the 2015 primary and secondary national ambient air quality standards (NAAQS) for ozone. On November 6, 2017, the Environmental Protection Agency (EPA) designated about 85 percent of the country as attainment/unclassifiable and three counties as unclassifiable. In this action, the EPA is designating all remaining areas, except for eight counties in the San Antonio, Texas metropolitan area. Areas are being designated as either nonattainment, attainment/unclassifiable, or unclassifiable. Areas designated as nonattainment are also being classified by operation of law according to the severity of their air quality problems. The classification categories are Marginal, Moderate, Serious, Severe, and Extreme. In addition, five nonattainment areas in California are being voluntarily reclassified to a higher classification.

The Environmental Protection Agency (EPA) is proposing to take the following four actions regarding the South Carolina State Implementation Plan (SIP): Approve the portion of South Carolina's September 5, 2017, SIP submittal seeking to change reliance from the Clean Air Interstate Rule (CAIR) to the Cross-State Air Pollution Rule (CSAPR) for certain regional haze requirements; convert EPA's limited approval/limited disapproval of South Carolina's regional haze plan to a full approval; remove EPA's Federal Implementation Plan (FIP) for South Carolina, which replaced reliance on CAIR with reliance on CSAPR to address the deficiencies identified in the limited disapproval of South Carolina's regional haze plan; and convert the conditional approvals of the visibility prong of South Carolina's infrastructure SIP submittals for the 2012 Fine Particulate Matter (PM2.5), 2010 Nitrogen Dioxide (NO2), 2010 Sulfur Dioxide (SO2), and 2008 8-hour Ozone National Ambient Air Quality Standards (NAAQS) to full approvals.

The U.S. Fish and Wildlife Service (Service or we) prescribes final frameworks from which States may select season dates, limits, and other options for the 2018-19 migratory bird hunting seasons. The effect of this final rule is to facilitate the States' selection of hunting seasons and to further the annual establishment of the migratory bird hunting regulations. We annually prescribe frameworks, or outer limits, for dates and times when hunting may occur and the number of birds that may be taken and possessed in hunting seasons. These frameworks are necessary to allow State selections of seasons and limits and to allow recreational harvest at levels compatible with population and habitat conditions.

On October 14, 2016, the Ohio Environmental Protection Agency (OEPA) submitted a State Implementation Plan (SIP) submission for the 2012 Fine Particle (PM2.5) National Ambient Air Quality Standards (``NAAQS'' or ``standards'') for the Cleveland nonattainment area. As required by the Clean Air Act (CAA), OEPA developed an attainment plan to address the Cleveland nonattainment area and evaluate the area's ability to attain the 2012 PM2.5 NAAQS by the ``Moderate'' attainment date of December 31, 2021. The SIP submission addresses specific requirements as outlined in the CAA including: Attainment demonstration; reasonable available control measure (RACM) analysis; emissions inventory requirements; reasonable further progress (RFP) with quantitative milestones; and nonattainment new source review (NNSR). Additionally, the SIP submission includes optional PM2.5 precursor demonstrations for NNSR and attainment planning purposes. EPA has evaluated the SIP submission and is proposing to approve portions of the submission as meeting the applicable CAA requirements for RACM, emissions inventory, attainment demonstration modeling, and precursor insignificance demonstrations for NNSR and attainment planning purposes. EPA is not acting on the other elements of the submission, including reasonable further progress (RFP), with quantitative milestones, and motor vehicle emission budgets (MVEBs).

We propose to adopt 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 proposed AD was prompted by reports that cracks were found on the door mechanism actuator shaft assemblies of the nose landing gear (NLG). This proposed AD would require repetitive inspections of the NLG door mechanism actuator shaft assemblies having certain part numbers, and corrective actions if necessary. This proposed 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 proposing this AD to address the unsafe condition on these products.

The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Connecticut. The SIP revision amends requirements for controlling volatile organic compound (VOC) emissions from consumer products and architectural and industrial maintenance (AIM) coatings by revising Regulations of Connecticut State Agencies (RCSA) sections 22a- 174-40, 22a-174-41, and adding section 22a-174-41a. The intended effect of this action is to propose approval of these regulations into the Connecticut SIP. This action is being taken in accordance with the Clean Air Act (CAA).

We are superseding Airworthiness Directive (AD) 2017-01-07, which applied to all Dassault Aviation Model FAN JET FALCON airplanes; Model FAN JET FALCON SERIES C, D, E, F, and G airplanes; Model MYSTERE- FALCON 200 airplanes; Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20- F5 airplanes; and Model MYSTERE-FALCON 50 airplanes. AD 2017-01-07 required a functional test or check of the main entry door closure and warning system, and applicable door closing inspections, adjustments, operational tests, and corrective actions if necessary. This AD requires repetitive door closing inspections, adjustments, operational tests, and corrective actions if necessary. This AD was prompted by a report indicating that during approach for landing, the main entry door detached from an airplane. We are issuing this AD to address the unsafe condition on these products.

On March 22, 2018, the State of Alabama, through the Alabama Department of Environmental Management (ADEM), submitted a request for the Environmental Protection Agency (EPA) to redesignate the Etowah County, Alabama fine particulate matter (PM2.5) unclassifiable area (hereinafter referred to as the ``Etowah County Area'' or ``Area'') to attainment for the 2006 primary and secondary 24-hour PM2.5 national ambient air quality standards (NAAQS). EPA now has sufficient data to determine that the Etowah County Area is in attainment of the 2006 primary and secondary 24-hour PM2.5 NAAQS. Therefore, EPA is proposing to approve the State's request and redesignate the Area to unclassifiable/ attainment for the 2006 primary and secondary 24-hour PM2.5 NAAQS based upon valid, quality-assured, and certified ambient air monitoring data showing that the PM2.5 monitor in the Area is in compliance with the 2006 primary and secondary 24-hour PM2.5 NAAQS.

This final rule amends the Summer Food Service Program (SFSP) regulations to incorporate statutory changes mandated by Section 738 of the Consolidated Appropriations Act, 2008, which extends simplified cost accounting and reporting procedures to SFSP sponsors in all States, and eliminates the cost comparison requirements for determining payments to sponsors. In addition, this rule makes several discretionary changes to improve administrative efficiency and reduce paperwork in the management of the SFSP. Finally, this rule amends the National School Lunch Program regulations to create consistency among the Child Nutrition Programs with regard to notice procedures. The intended effect of this rule is to simplify and streamline Program administration while ensuring Program integrity.

We, the U.S. Fish and Wildlife Service, are removing the plant Trichostema austromontanum ssp. compactum (Hidden Lake bluecurls) from the Federal List of Endangered and Threatened Plants on the basis of recovery. This action is based on a review of the best available scientific and commercial information, which indicates that the threats to T. a. ssp. compactum have been eliminated or reduced to the point where it no longer meets the definition of an endangered species or a threatened species under the Endangered Species Act of 1973, as amended. This rule also announces the availability of a post-delisting monitoring plan for T. a. ssp. compactum.

The Coast Guard is establishing a temporary special local regulation for all navigable waters of the Osage arm of the Lake of the Ozarks from mile marker (MM) 0.0 to MM 0.4 in Bagnell, MO. This special local regulation is necessary to protect the public, participants, spectators, and the marine environment from potential hazards during the Lake Race 2018. Entry of persons or vessels into this regulated area is prohibited unless authorized by the Captain of the Port Sector Upper Mississippi River or a designated representative.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Long Beach Bridge across Reynolds Channel, mile 4.7, and the Loop Parkway Bridge across Long Creek, mile 0.7, at Nassau County, New York. This deviation is necessary to facilitate a fireworks display and allows the bridge to remain in the closed position for two and a half hours.

The Coast Guard is establishing a temporary safety zone on the navigable waters of the Upper Mississippi River between mile markers 179 and 180, extending the entire width of the river. This action is necessary to provide for the safety of life and property on these navigable waters near the St. Louis Gateway Arch grounds during an air show practice and an air show/fireworks display. This temporary safety zone is necessary to protect persons and property from potential damage and safety hazards during the air show evolutions. Entry into the safety zone is prohibited unless authorized by the Captain of the Port Sector Upper Mississippi River or a designated representative.

We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 777-200 and -300 series airplanes. This proposed AD was prompted by reports of unreliable performance of the water and fuel scavenge system; failure of the fuel scavenge function can cause trapped fuel, resulting in unavailable fuel reserves. This proposed AD would require incorporating operating limitations, or modifying the water and fuel scavenge systems in the fuel tanks and certain electrical panels. We are proposing this AD to address the unsafe condition on these products.

We propose to adopt a new airworthiness directive (AD) for all Airbus Model A310 series airplanes. This proposed AD was prompted by a determination that new or more restrictive maintenance requirements and airworthiness limitations are necessary. This proposed AD would require revising the maintenance or inspection program, as applicable, to incorporate new or more restrictive maintenance requirements and airworthiness limitations. We are proposing this AD to address the unsafe condition on these products.

The Office of Population Affairs (OPA), in the Office of the Assistant Secretary for Health, proposes to revise its Title X regulations (Title X of the Public Health Service Act) to ensure compliance with, and enhance implementation of, the statutory requirement that none of the funds appropriated for Title X may be used in programs where abortion is a method of family planning and related statutory requirements. In addition, OPA proposes amendments to the Title X regulations that would, among other things, clarify grantee responsibilities to provide a broad range of family planning methods; to require documented compliance with State and local laws requiring notification or the reporting of child abuse, child molestation, sexual abuse, rape, incest, intimate partner violence, and human trafficking; to provide free or low cost access to family planning services for those women who are unable to obtain employer-sponsored insurance coverage for certain contraceptive services due to their employers' religious beliefs or moral convictions; to provide for the appropriate expenditure of federal Title X funds on family planning services, rather than on lobbying or related activities; and to appropriately encourage family participation in family planning decisions, all as required by Federal law.

OSHA is proposing a nine-month extension of the compliance date for certain ancillary requirements of the general industry beryllium standard (from March 12, 2018 to December 12, 2018). This proposal would not extend the compliance date for the permissible exposure limits (PELs), exposure assessment, respiratory protection, medical surveillance, or medical removal protection provisions, or for any provisions for which the standard already establishes compliance dates in 2019 and 2020. OSHA has preliminarily determined that this proposal will maintain essential safety and health protections for workers while OSHA prepares an NPRM to clarify specific provisions of the beryllium standard that would both maintain the standard's worker safety and health protections and address employers' compliance burdens.

The Environmental Protection Agency (EPA) is approving a state implementation plan (SIP) revision formally submitted by the Commonwealth of Virginia (Virginia or the Commonwealth). Under the Clean Air Act (CAA), states' SIPs must require stationary sources in ozone nonattainment areas classified as marginal or above to report annual emissions of nitrogen oxides (NOX) and volatile organic compounds (VOC). This emissions statement requirement also applies to stationary sources located in the Ozone Transport Region (OTR) that emit or have the potential to emit at least 50 tons per year (tpy) of VOC or 100 tpy of NOX. The SIP revision provides Virginia's certification that its existing emissions statement program satisfies the emissions statement requirements of the CAA for the 2008 ozone National Ambient Air Quality Standards (NAAQS). EPA is approving Virginia's emissions statement program certification for the 2008 ozone NAAQS as a SIP revision in accordance with the requirements of the CAA.