| Page Range | 52943-53157 | |
| FR Document |
| Page and Subject | |
|---|---|
| 83 FR 53157 - Memorandum for the Secretary of Defense [and] the Secretary of Commerce | |
| 83 FR 53028 - Sunshine Act Meeting Notice | |
| 83 FR 53027 - Sunshine Act Meeting | |
| 83 FR 52962 - Regulation Crowdfunding and Regulation A Relief and Assistance for Victims of Hurricane Michael | |
| 83 FR 53104 - Notice of Intent To Prepare an Environmental Impact Statement for Deepwater Wind South Fork, LLC's Proposed Wind Energy Facility Offshore Rhode Island and Massachusetts | |
| 83 FR 53096 - Commercial Leasing for Wind Power Development on the Outer Continental Shelf (OCS) Offshore California-Call for Information and Nominations (Call) | |
| 83 FR 53089 - Atlantic Wind Lease Sale 4A (ATLW-4A) for Commercial Leasing for Wind Power on the Outer Continental Shelf Offshore Massachusetts-Final Sale Notice | |
| 83 FR 53028 - Notice of Public Meeting of the West Virginia Advisory Committee | |
| 83 FR 53105 - Certain LTE- and 3G-Compliant Cellular Communications Devices Institution of Investigation | |
| 83 FR 52977 - Safety Zone; Delaware River; Penn's Landing; Philadelphia, PA; Fireworks Display | |
| 83 FR 53141 - Presidential Declaration of a Major Disaster for Public Assistance Only for the State of North Carolina | |
| 83 FR 53023 - Safety Zone; NASA Activities, Gulf of Mexico, Galveston, TX | |
| 83 FR 53029 - In the Matter of: Luis Antonio Urdaneta Pozo, Inmate Number: 68375-018, FCI Edgefield, P.O. Box 725, Edgefield, SC 29824; Order Denying Export Privileges | |
| 83 FR 53142 - Presidential Declaration of a Major Disaster for the State of Georgia | |
| 83 FR 53033 - Proposed Monterey Peninsula Water Supply Project; Notice of Availability of Errata Document for the Final Environmental Impact Report/Environmental Impact Statement | |
| 83 FR 52996 - Tetrahydrofurfuryl Alcohol; Exemption From the Requirement of a Tolerance | |
| 83 FR 53050 - Agency Information Collection Activities; Comment Request; The Department of Education Accrediting Agency, Foreign Medical and Foreign Veterinarian Program Comparability Database Approval | |
| 83 FR 53054 - Pesticide Registration Maintenance Fee: Notice of Receipt of Requests To Voluntarily Cancel Certain Pesticide Registrations | |
| 83 FR 52950 - Responsibilities of Boards of Directors, Corporate Practices, and Corporate Governance | |
| 83 FR 53111 - Leadership in Equal Access and Diversity Award; New Information Collection Requirements; Comment Request | |
| 83 FR 52986 - Prothioconazole; Pesticide Tolerances | |
| 83 FR 53143 - Presidential Declaration Amendment of a Major Disaster for the State of Florida | |
| 83 FR 53072 - Certificate of Alternative Compliance for the Blount Boats Inc., Hull TGI-329 | |
| 83 FR 52991 - Boscalid; Pesticide Tolerances | |
| 83 FR 52954 - Amendment of the Prohibition Against Certain Flights in Specified Areas of the Simferopol and Dnipropetrovsk Flight Information Regions (FIRs) (UKFV and UKDV) | |
| 83 FR 53114 - Advisory Committee for Mathematical and Physical Sciences; Notice of Meeting | |
| 83 FR 53144 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition-Determinations: “Mrinalini Mukherjee” Exhibition | |
| 83 FR 53143 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition-Determinations: “Renaissance Splendor: Catherine de Medici's Valois Tapestries” Exhibition | |
| 83 FR 53114 - Proposal Review Panel for International Science and Engineering; Notice of Meeting | |
| 83 FR 53142 - Presidential Declaration of a Major Disaster for the State of Florida | |
| 83 FR 52981 - Safety Zone; Fox River, Brown County Fireworks, Green Bay, WI | |
| 83 FR 53118 - Performance Review Boards for Senior Executive Service | |
| 83 FR 53030 - Carbon and Certain Alloy Steel Wire Rod From Mexico: Preliminary Affirmative Determination of Circumvention of the Antidumping Duty Order | |
| 83 FR 52972 - Medical Devices; Neurological Devices; Classification of the Thermal Vestibular Stimulator for Headache | |
| 83 FR 53032 - Subsidy Programs Provided by Countries Exporting Softwood Lumber and Softwood Lumber Products to the United States; Request for Comment | |
| 83 FR 52964 - Medical Devices; Anesthesiology Devices; Classification of the Positive Airway Pressure Delivery System | |
| 83 FR 53143 - Department of State Performance Review Board Members | |
| 83 FR 52966 - Medical Devices; General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device | |
| 83 FR 53149 - Commercial Driver's License Standards: Application for Exemption; CRST Expedited | |
| 83 FR 53114 - Membership of National Science Foundation's Senior Executive Service Performance Review Board | |
| 83 FR 53151 - Commercial Driver's License Standards: Application for Exemption; Isuzu North America Corporation (Isuzu) | |
| 83 FR 53077 - Final Environmental Impact Statement on American Electric Power's American Burying Beetle Habitat Conservation Plan in Arkansas, Oklahoma, and Texas | |
| 83 FR 53107 - Importer of Controlled Substances Application: Noramco Inc. | |
| 83 FR 53119 - Oyster Creek Nuclear Generating Station; Consideration of Approval of Transfer of License and Conforming Amendment | |
| 83 FR 53107 - Importer of Controlled Substances Registration | |
| 83 FR 53106 - Bulk Manufacturer of Controlled Substances Registration | |
| 83 FR 53108 - Importer of Controlled Substances Application: Fisher Clinical Services, Inc. | |
| 83 FR 53106 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Consortium for Execution of Rendezvous and Servicing Operations | |
| 83 FR 52979 - Safety Zone; Hornblower Fireworks Display; San Francisco Bay; San Francisco, CA | |
| 83 FR 53027 - Information Collection Activity; Comment Request | |
| 83 FR 53029 - Suspension of the Geographically Updated Population Certification Program for Places Incorporating or Annexing Between Censuses | |
| 83 FR 53050 - Combined Notice of Filings | |
| 83 FR 53065 - Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs | |
| 83 FR 53052 - Luminant Energy Company LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 83 FR 53061 - Notice of Agreements Filed | |
| 83 FR 53053 - Combined Notice of Filings #1 | |
| 83 FR 53052 - Alpine Pacific Utilities Hydro, LLC; Notice of Availability of Environmental Assessment | |
| 83 FR 53081 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Data Elements for Student Enrollment in Bureau-Funded Schools | |
| 83 FR 53122 - New Postal Products | |
| 83 FR 53060 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Facility Ground-Water Monitoring Requirements (Renewal) | |
| 83 FR 53070 - National Maritime Security Advisory Committee; Meeting | |
| 83 FR 53033 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to US 101/Chehalis River Bridge-Scour Repair in Washington State | |
| 83 FR 53059 - Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of Georgia | |
| 83 FR 53115 - Interim Storage Partners LLC's Consolidated Interim Storage Facility | |
| 83 FR 53048 - Endangered and Threatened Species; Take of Anadromous Fish | |
| 83 FR 53059 - Proposed Information Collection Request; Comment Request; Fuel Use Requirements for Great Lake Steamships; Renewal | |
| 83 FR 53152 - Proposed Collection; Comment Request for Form 8832 | |
| 83 FR 53067 - Determination of Regulatory Review Period for Purposes of Patent Extension; IMFINZI | |
| 83 FR 53068 - Sanofi-Aventis, U.S., LLC, et al.; Withdrawal of Approval of 20 New Drug Applications | |
| 83 FR 53108 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection; Comments Requested: 2019 School Crime Supplement (SCS) to the National Crime Victimization Survey (NCVS) | |
| 83 FR 53109 - Agency Information Collection Activities: Proposed eCollection eComments Requested; Reinstatement, With Change, of a Previously Approved Collection: 2018 Census of Law Enforcement Training Academies (CLETA) | |
| 83 FR 53110 - Agency Information Collection Activities; Proposed eCollection; eComments Requested; New Collection: Survey of State Attorneys General Offices (SSAGO): Human Trafficking | |
| 83 FR 52976 - Drawbridge Operation Regulation; Willamette River at Portland, OR | |
| 83 FR 53113 - Human Exploration and Operations Research Advisory Committee; Meeting | |
| 83 FR 53113 - NASA Advisory Council; Aeronautics Committee; Meeting | |
| 83 FR 53088 - Notice of Intent To Repatriate Cultural Items: Fowler Museum at the University of California Los Angeles, Los Angeles, CA | |
| 83 FR 53087 - Notice of Inventory Completion: The Field Museum, Chicago, IL | |
| 83 FR 53084 - Notice of Inventory Completion: Department of Anthropology at Indiana University, Bloomington, IN | |
| 83 FR 53085 - Notice of Inventory Completion: Fowler Museum at the University of California Los Angeles, Los Angeles, CA | |
| 83 FR 53083 - Notice of Intent To Repatriate Cultural Items: Fowler Museum at the University of California Los Angeles, Los Angeles, CA | |
| 83 FR 53086 - Notice of Inventory Completion: Fowler Museum at the University of California Los Angeles, Los Angeles, CA; Correction | |
| 83 FR 53082 - Notice of Inventory Completion: Fowler Museum at the University of California Los Angeles, Los Angeles, CA; Correction | |
| 83 FR 53049 - Procurement List; Deletions | |
| 83 FR 53049 - Procurement List; Proposed Addition and Deletions | |
| 83 FR 53071 - Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0095 | |
| 83 FR 52968 - Medical Devices; General and Plastic Surgery Devices; Classification of the Light Based Energy Source Device for Topical Application | |
| 83 FR 52973 - Medical Devices; Ophthalmic Devices; Classification of the Intranasal Electrostimulation Device for Dry Eye Symptoms | |
| 83 FR 52970 - Medical Devices; General and Plastic Surgery Devices; Classification of the Hemostatic Device for Intraluminal Gastrointestinal Use | |
| 83 FR 53072 - Agency Information Collection Activities: Allegation of Counterfeiting and Intellectual Piracy, Form No. 73-048 | |
| 83 FR 53127 - Submission for OMB Review; Comment Request | |
| 83 FR 53128 - Self-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Clearing Agency Policy on Capital Requirements and the Clearing Agency Capital Replenishment Plan | |
| 83 FR 53138 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Clearing Agency Policy on Capital Requirements and the Clearing Agency Capital Replenishment Plan | |
| 83 FR 53131 - Self-Regulatory Organizations; Fixed Income Clearing Corporation; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Clearing Agency Policy on Capital Requirements and the Clearing Agency Capital Replenishment Plan | |
| 83 FR 53134 - Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Delete Current Rules on Arbitration, Under Chapter 18 | |
| 83 FR 53136 - Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to ICC's Stress Testing Framework and ICC's Liquidity Risk Management Framework | |
| 83 FR 53124 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Order Granting Approval of a Proposed Rule Change, as Modified by Amendment No. 1, Relating to the First Trust Senior Loan Fund of First Trust Exchange-Traded Fund IV | |
| 83 FR 53123 - Product Change-Priority Mail Negotiated Service Agreement | |
| 83 FR 53123 - Product Change-Priority Mail Express and Priority Mail Negotiated Service Agreement | |
| 83 FR 53116 - In the Matter of Entergy Nuclear Vermont Yankee, LLC; Entergy Nuclear Operations, Inc.; NorthStar Vermont Yankee LLC; NorthStar Nuclear Decommissioning Company, LLC; Vermont Yankee Nuclear Power Station | |
| 83 FR 53144 - Projects Rescinded for Consumptive Uses of Water | |
| 83 FR 53144 - Projects Approved for Consumptive Uses of Water | |
| 83 FR 53073 - Endangered and Threatened Species; Receipt of Recovery Permit Applications | |
| 83 FR 53075 - South Bay Salt Pond Restoration Project, Phase 2; Don Edwards National Wildlife Refuge, California; Record of Decision for Final Environmental Impact Statement/Environmental Impact Report | |
| 83 FR 52946 - Hazelnuts Grown in Oregon and Washington; Order Amending Marketing Order No. 982 | |
| 83 FR 52943 - General Regulations for Federal Fruit, Vegetable, and Specialty Crop Marketing Agreements and Orders; Electronic Mailing of Notice of Hearing | |
| 83 FR 53069 - National Heart, Lung, and Blood Institute Notice of Closed Meetings | |
| 83 FR 52944 - Oranges and Grapefruit Grown in Lower Rio Grande Valley in Texas; Changing of Container Requirements | |
| 83 FR 53003 - Oranges, Grapefruit, Tangerines, and Pummelos Grown in Florida and Imported Grapefruit; Change in Grade and Size Requirements | |
| 83 FR 53145 - Petition for Exemption; Summary of Petition Received; Anthony Ison, Esq. | |
| 83 FR 53078 - Eastern Collier Property Owners, LLC, Multi-Species Habitat Conservation Plan and Draft Environmental Impact Statement, Collier County, Florida | |
| 83 FR 53064 - Agency Information Collection Activities; Proposed Collection; Public Comment Request; Centers for Independent Living Program Performance Report (0985-NEW) | |
| 83 FR 53063 - Agency Information Collection Activities; Proposed Collection; Public Comment Request; the State Plan for Independent Living (SPIL) (0985-0044) | |
| 83 FR 53020 - Foreign Criminal and Civil Jurisdiction | |
| 83 FR 53062 - Agency Information Collection Activities; Proposed Collection; Public Comment Request; Independent Living Services Program Performance Report (0985-0043) | |
| 83 FR 53074 - Endangered and Threatened Wildlife; Incidental Take Permit Application, Habitat Conservation Plan for the Sand Skink, Lake County, FL | |
| 83 FR 53080 - Endangered and Threatened Wildlife and Plants; Availability of Habitat Conservation Plan and Categorical Exclusion for the Mount Hermon June Beetle, Santa Cruz County, California | |
| 83 FR 53061 - Notice to All Interested Parties of Intent To Terminate Receivership | |
| 83 FR 52976 - Drawbridge Operation Regulation; Sacramento River, Sacramento, CA | |
| 83 FR 53053 - Environmental Impact Statements; Notice of Availability | |
| 83 FR 53112 - Petitions for Modification of Application of Existing Mandatory Safety Standard | |
| 83 FR 53152 - Advisory Committee on Cemeteries and Memorials, Notice of Meeting | |
| 83 FR 53147 - Parts and Accessories Necessary for Safe Operation; Application for an Exemption From Castignoli Enterprises | |
| 83 FR 53007 - Capital, Margin, and Segregation Requirements for Security-Based Swap Dealers and Major Security-Based Swap Participants and Capital Requirements for Broker-Dealers | |
| 83 FR 53145 - Notice of Final Federal Agency Actions on Transportation Project in Washington State | |
| 83 FR 53146 - Notice of Final Federal Agency Actions on Transportation Project in Washington State | |
| 83 FR 53026 - Petition for Reconsideration of Action in Rulemaking Proceeding; Correction | |
| 83 FR 52983 - Determination of Attainment by the Attainment Date and Clean Data Determination for the Logan, UT-ID 2006 24-Hour PM2.5 |
Agricultural Marketing Service
Rural Utilities Service
Census Bureau
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
Community Living Administration
Food and Drug Administration
National Institutes of Health
Coast Guard
U.S. Immigration and Customs Enforcement
Fish and Wildlife Service
Indian Affairs Bureau
National Park Service
Ocean Energy Management Bureau
Antitrust Division
Drug Enforcement Administration
Justice Programs Office
Federal Contract Compliance Programs Office
Mine Safety and Health Administration
Federal Aviation Administration
Federal Highway Administration
Federal Motor Carrier Safety Administration
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Agricultural Marketing Service, USDA.
Final rule.
This rule revises the general regulations for Federal fruit, vegetable, and specialty crop marketing agreements and marketing orders (orders) to allow the use of electronic communication as a method for notifying industry and the public of hearings for proceedings related to proposing new or amending existing orders.
Effective October 19, 2018.
Debbie Wray, Senior Marketing Specialist, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 2202 Monterey Street, Suite 102-B, Fresno, CA 93721; Telephone: (559) 487-5901, Fax: (559) 487-5906 or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
This final rule is issued under the general regulations for Federal marketing agreements and orders (7 CFR part 900), effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”
The Department of Agriculture (USDA) is issuing this final rule in conformance with Executive Orders 12866, 13563, and 13175. Additionally, because this rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See the Office of Management and Budget's (OMB) Memorandum titled, “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).
This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
This final rule authorizes USDA's Agricultural Marketing Service (AMS) to use either electronic communication or a postal or other delivery service to mail a notice of hearing to industry and the public for proceedings related to proposing new or amending existing orders.
Part 900 provides the procedural requirements that govern proceedings to formulate orders and when necessary, to amend existing orders. These proceedings include holding a public hearing where, among other things, witnesses provide testimony about the proposal and evidence is admitted for consideration by the Secretary of Agriculture.
Section 900.4(b) requires AMS to mail a true copy of a notice of hearing to each of the persons known to the AMS Administrator to be interested in the proceedings. However, the method to be used for mailing the notice is not specified. Historically, AMS has mailed paper copies of the notice using the United States Postal Service or other postal delivery services. These mailings may number in the hundreds, depending on the industry affected by the proposal.
This final rule revises § 900.4 to provide that the mailing of a notice of hearing may be done electronically or by using a postal or other delivery service. By providing that electronic communication may be used for mailing, this action will help strengthen and modernize AMS's outreach process and will reduce costs associated with paper mailings. Eventually, if all notice recipients have access to electronic communication as a delivery method and have adapted to its use, the older, more costly paper delivery methods could be eliminated.
This final rule revises agency rules of practice and procedure. Under the Administrative Procedure Act, prior notice and opportunity for comment are not required for the revision of agency rules of practice and procedure. 5 U.S.C. 553(b)(3)(A). Only substantive rules require publication 30 days prior to their effective date. 5 U.S.C. 553(d). Therefore, this final rule is effective upon publication in the
In addition, because prior notice and opportunity for comment are not required to be provided for this final rule, this rule is exempt from the requirements of the Regulatory Flexibility Act, 5 U.S.C. 601,
This rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
AMS is committed to complying with the E-Government Act to promote the use of the internet and other information technologies, to provide increased opportunities for citizen
USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
Administrative practice and procedure, Freedom of information, Marketing agreements, Reporting and recordkeeping requirements.
For the reasons set forth above, 7 CFR part 900 is amended as follows:
7 U.S.C. 601-674 and 7 U.S.C. 7401.
(b) * * *
(1) * * *
(ii) By mailing a true copy of the notice of hearing, using a postal or other delivery service or electronic communication, to each of the persons known to the Administrator to be interested therein;
Agricultural Marketing Service, USDA.
Final rule.
This rule implements a recommendation to change the container requirements under the Marketing Order for oranges and grapefruit grown in the Lower Rio Grande Valley in Texas. This action removes five containers from the list of authorized containers and adds seven new containers to the list. This change also modifies the descriptions of two authorized containers.
Effective November 19, 2018.
Doris Jamieson, Marketing Specialist, or Christian D. Nissen, Regional Director, Southeast Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (863) 324-3375, Fax: (863) 291-8614, or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
This final rule, pursuant to 5 U.S.C. 553, amends regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This final rule is issued under Marketing Agreement and Order No. 906, as amended (7 CFR part 906), regulating the handling of oranges and grapefruit grown in the Lower Rio Grande Valley in Texas. Part 906 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Texas Valley Citrus Committee (Committee) locally administers the Order and is comprised of growers and handlers of Texas citrus operating within the production area.
The Department of Agriculture (USDA) is issuing this final rule in conformance with Executive Orders 13563 and 13175. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
This final rule removes five containers from the list of authorized containers under the Order and adds seven new containers to the list. This action also modifies the descriptions of two authorized containers. The Committee recommended these changes to align the Order's container regulations with current industry practices. The Committee unanimously recommended the changes at a meeting on June 8, 2017.
Section 906.40(d) of the Order authorizes the issuance of regulations to fix the size, weight, capacity, dimensions, or pack of the container or containers which may be used in the packaging, transportation, sale, shipment, or other handling of fruit. Section 906.340 provides that no handler shall handle any variety of oranges or grapefruit grown in the production area unless such fruit is packed in one of the containers specified under the Order. This section also specifies a detailed list of the containers currently authorized under the Order. In addition, this section allows the Committee to approve the use of other types and sizes of containers for testing for research purposes.
The Committee reviewed the containers listed in § 906.340 and compared them to the containers being utilized throughout the industry. This process included surveying handlers to determine which containers were being used. As a result, the Committee determined five of the authorized
The Committee also reviewed the list of experimental containers that had been approved for testing purposes. Seven of the experimental containers have been widely accepted throughout the Texas citrus industry and are being used to pack and ship Texas citrus. As a result of the review, the Committee voted to remove the five containers that were no longer being used from the list of authorized containers and add the seven experimental containers to § 906.340.
The Committee also discussed that while the description in § 906.340(a)(1)(ii) of the closed fully telescopic fiberboard carton with approximate inside dimensions of 16
Further, the Committee noted that in § 906.340(a)(1)(iv) poly or mesh bags can be used to pack oranges and grapefruit to a capacity of 5, 8, 10, or 18 pounds of fruit, but that only oranges can be packed in the 4-pound bags. During the discussion, Committee members agreed handlers should also be allowed to ship grapefruit in 4-pound bags. Thus, the Committee voted to update the description to allow for the packing of both oranges and grapefruit in poly or mesh bags having a capacity of 4 pounds.
These changes reflect the containers being utilized throughout the industry and aligns the regulations with current industry practices.
Section 8e of the Act provides that when certain domestically produced commodities, including oranges, are regulated under a Federal marketing order, imports of that commodity must meet the same or comparable grade, size, quality, and maturity requirements. As this rule changes the container requirements under the domestic handling regulations, no corresponding change to the import regulations is required.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 170 producers of oranges and grapefruit in the production area and 13 handlers subject to regulation under the Order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).
Based on National Agricultural Statistics Service (NASS) and Committee data, the average price for Texas citrus during the 2016-17 season was approximately $16 per carton, and total shipments were 7.6 million cartons. Using the average price and shipment information, the number of handlers (13), and assuming a normal distribution, the majority of handlers would have average annual receipts of $9.4 million, which is greater than $7,500,000. ($16 per carton times 7.6 million cartons equals $121.6 million, divided by 13 equals $9.4 million per handler.) Thus, the majority of Texas citrus handlers may be classified as large business entities.
In addition, based on NASS information, the weighted grower price for Texas citrus during the 2016-17 season was approximately $9.35 per carton. Using the weighted average price and shipment information, the number of producers (170) and assuming a normal distribution, the majority of producers would have annual receipts of $418,000, which is less than $750,000. ($9.35 per carton times 7.6 million cartons equals $71.06 million, divided by 170 equals $418,000 per producer.) Thus, the majority of Texas citrus producers may be classified as small entities.
This final rule revises the container requirements established under the Order. This rule removes five containers from the list of authorized containers and adds seven new containers to the list. This action also updates one container to allow handlers to use it to pack oranges and grapefruit, and modifies the description of another container to indicate it is the standard container used by the industry. These changes align the list of authorized containers with current industry needs and practices. This rule revises § 906.340. Authority for these changes is provided in § 906.40.
It is not anticipated that this final rule will impose additional costs on handlers or growers, regardless of size. The containers removed from the list of authorized containers are no longer being used by the industry. This rule provides an additional container for packing grapefruit, clarifies the description for one container, and adjusts the container regulations to better reflect current industry practices. The benefits of this rule are expected to be equally available to all fresh orange and grapefruit growers and handlers, regardless of size.
The Committee considered alternatives to this action, including making no changes to the list of authorized containers. However, it was determined that making the recommended changes provides an up-to-date list of containers currently being used by the Texas citrus industry. Therefore, the Committee rejected this alternative.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0189, Fruit Crops. No changes in those requirements are necessary as a result of this action. Should any changes become necessary, they would be submitted to OMB for approval.
This final rule does not impose any additional reporting or recordkeeping requirements on either small or large Texas orange and grapefruit handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
AMS is committed to complying with the E-Government Act to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.
The Committee's meeting was widely publicized throughout the Texas citrus industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the June 8, 2017, meeting was a public meeting and all entities, both large and small, were able to express their views on this issue.
A proposed rule concerning this action was published in the
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
After consideration of all relevant matter presented, including the information and recommendation submitted by the Committee and other available information, it is hereby found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.
Grapefruit, Marketing agreements, Oranges, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, 7 CFR part 906 is amended as follows:
7 U.S.C. 601-674.
(a) * * *
(1)
(ii) Closed fully telescopic fiberboard carton with approximate inside dimensions of 16
(iii) Poly or mesh bags having a capacity of 4, 5, 8, 10, or 18 pounds of fruit;
(iv) Rectangular or octagonal bulk fiberboard crib with approximate dimensions of 46 to 47
(v) Rectangular or octagonal
(vi) Octagonal fiberboard crib with approximate dimensions of 46 to 47
(vii) Fiberboard box holding two layers of fruit, with approximate dimensions of 23 inches in length, 15
(viii) Reusable collapsible plastic container with approximate dimensions of 23 inches in length, 15 inches in width, and 7 to 11 inches in depth;
(ix) Reusable collapsible plastic bin with approximate dimensions of 36
(x) Octagonal bulk triple wall fiberboard crib with approximate dimensions of 37
(xi) Bag having the capacity of 15 pounds of fruit, either in a combination
(xii) Reusable collapsible plastic mini bin with approximate dimensions of 39
(xiii) Bag having the capacity of three pounds of fruit;
(xiv) Standard carton with approximate inside dimensions of 16.375 x 10.6875 x 10.25 inches;
(xv)
(xvi) Euro
(xvii) Fiberboard one piece display container with approximate inside dimensions of 23 inches x 15 inches x 9
(xviii) Such types and sizes of containers as may be approved by the committee for testing in connection with a research project conducted by or in cooperation with the committee:
Agricultural Marketing Service, USDA.
Final rule.
This final rule amends Marketing Order No. 982 (Order), which regulates the handling of hazelnuts grown in Oregon and Washington. The amendments were proposed by the Hazelnut Marketing Board (Board) and add the authority to regulate quality for the purpose of pathogen reduction and to establish different regulations for different markets.
This final rule also makes administrative revisions to subpart headings to bring the language into conformance with the Office of Federal Register requirements.
This rule is effective November 19, 2018.
Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, Stop 0237, Washington, DC 20250-0237.
Melissa Schmaedick, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, Post Office Box 952, Moab, UT 84532; Telephone: (202) 557-4783, Fax: (435) 259-1502, or Michelle Sharrow, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, Stop 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
Small businesses may request information on this proceeding by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, Stop 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
Prior documents in this proceeding: Notice of Hearing issued on September 27, 2016, and published in the September 30, 2016, issue of the
This action is governed by the provisions of sections 556 and 557 of title 5 of the United States Code and, therefore, is excluded from the requirements of Executive Orders 12866, 13563, and 13175. Additionally, because this rule does not meet the definition of a significant regulatory action it does not trigger the requirements contained in Executive Order 13771. See the Office of Management and Budget's (OMB) Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).
Notice of this rulemaking action was provided to tribal governments through the Department of Agriculture's (USDA) Office of Tribal Relations.
This action finalizes an amendment to regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This rule is issued under Marketing Order No. 982, as amended (7 CFR part 982), regulating the handling of hazelnuts grown in Oregon and Washington. Part 982 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The final rule was formulated on the record of a public hearing held on October 18, 2016, in Wilsonville, Oregon. The hearing was held pursuant to the provisions of the Act, and the applicable rules of practice and procedure governing the formulation of marketing agreements and orders (7 CFR part 900). Notice of this hearing was published in the
Upon the basis of evidence introduced at the hearing and the record thereof, the Administrator of the Agricultural Marketing Service (AMS) on June 5, 2017, filed with the Hearing Clerk, USDA, a Recommended Decision and Opportunity to File Written Exceptions thereto by July 12, 2017. No exceptions were filed.
A Secretary's Decision and Referendum Order was published in the
The amendments favored by voters and included in this final order authorize the regulation of quality for the purpose of pathogen reduction and the establishment of different outgoing quality regulations for different markets.
USDA also made such changes as were necessary to the Order so that all of the Order's provisions conform to the effectuated amendments. USDA recommended one clarifying change to the language in the new paragraph 982.45(c), which adds authority to regulate quality. USDA determined that the language as presented in the Notice of Hearing was redundant and, therefore, confusing. USDA revised the language in the new paragraph § 982.45(c) so that its intent is more clearly stated. This language is included in the regulatory text of this Order.
The amended marketing agreement was subsequently mailed to all hazelnut handlers in the production area for their approval. The marketing agreement was not approved by handlers representing more than 50 percent of the volume of hazelnuts handled by all handlers during the representative period of July 1, 2016, through June 30, 2017. Consequently, no companion handler agreement will be established.
Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA), AMS has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions so that small businesses will not be unduly or disproportionately burdened. Marketing orders and amendments thereto are unique in that they are normally brought about through group action of essentially small entities for their own benefit.
According to the hearing transcript, there are currently over 800 hazelnut growers in the production area. According to National Agricultural Statistics Service (NASS) data presented at the hearing, 2015 grower receipts averaged $2,800 per ton. With a total 2015 production of 31,000 tons, the farm gate value for hazelnuts in that year totaled $86.8 million ($2,800 per ton multiplied by 31,000 tons). Taking the total value of production for hazelnuts and dividing it by the total number of hazelnut growers provides a return per grower of $108,500. A small grower as defined by the Small Business Administration (SBA) (13 CFR 121.201) is one having annual receipts of less than $750,000 annually. Therefore, a majority of hazelnut growers are considered small entities under the SBA standards. Record evidence indicates that approximately 98 percent of hazelnut growers are small businesses.
According to the industry, there are 17 hazelnut handlers, four of which handle 80 percent of the crop. While market prices for hazelnuts were not included among the data presented at
The production area regulated under the Order covers Oregon and Washington. According to the record, Eastern Filbert Blight has heavily impacted hazelnut production in Washington. One witness stated that there is currently no commercial production in that state. As a result, production data entered into the record pertains almost exclusively to Oregon.
NASS data indicates bearing acres of hazelnuts reached a fifteen-year high during the 2013-2014 crop year at 30,000 acres. Acreage remained steady, at 30,000 bearing acres for the 2015-2016 crop year. By dividing 30,000 acres by 800 growers, NASS data indicate there are approximately 37.5 acres per grower. Industry testimony estimates that due to new plantings, there are potentially 60,000 bearing acres of hazelnuts, or an estimated 75 bearing acres per hazelnut grower.
During the hearing held October 18, 2016, interested parties were invited to present evidence on the probable regulatory impact of the amendments to the Order on small businesses. The evidence presented at the hearing shows that none of the amendments would have a significant economic impact on a substantial number of small agricultural growers or firms.
This action amends the Order to authorize the regulation of quality for the purpose of pathogen reduction and the establishment of different outgoing quality regulations for different markets. These authorities will aid in pathogen reduction in hazelnuts and increase the industry's ability to meet the needs of different market destinations.
During the hearing held on October 18, 2016, interested persons were invited to present evidence on the probable regulatory and informational impact of the amendments to the Order on small businesses. The evidence presented at the hearing shows that the amendments would have no burdensome effects on small agricultural producers or firms.
In discussing the impacts of the amendments on growers and handlers, record evidence indicates that the authority to establish quality regulations that require hazelnuts to be treated prior to shipment to reduce pathogen load would not significantly impact the majority of handlers. Regulations implemented under that authority could impose additional costs on handlers required to comply with them. However, witnesses testified that establishing mandatory treatment regulations could increase the industry's credibility and reduce the risk that shipments of substandard product could jeopardize the entire industry's reputation. Record evidence shows that any additional costs are likely to be offset by the benefits of complying with those requirements.
The record shows that the proposal to add authority to establish different outgoing quality requirements for different markets would, in itself, have no economic impact on growers or handlers of any size. While regulations implemented under that authority could potentially impose additional costs on handlers required to comply with them, the record indicates the benefits of such regulation would outweigh the potential future costs. The record indicates that allowing different regulations for different markets would likely lower the costs to handlers and prevent multiple treatments of hazelnuts while preserving hazelnut quality.
This final rule also makes administrative revisions to subpart headings to bring the language into conformance with the Office of Federal Register requirements.
USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule. These amendments are intended to improve the operation and administration of the Order and to assist in the marketing of hazelnuts.
Current information collection requirements for Part 982 are approved by OMB, under 0581-0178 “Vegetable and Specialty Crops.” No changes are anticipated in these requirements as a result of this proceeding. Should any such changes become necessary, they would be submitted to OMB for approval.
As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public-sector agencies.
AMS is committed to complying with the Government Paperwork Elimination Act, which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible.
AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
The amendments to the Order stated herein have been reviewed under Executive Order 12988, Civil Justice Reform. They are not intended to have retroactive effect. The amendments do not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed no later than 20 days after the date of entry of the ruling.
The findings and determinations hereinafter set forth are supplementary to the findings and determinations that were previously made in connection with the issuance of the Marketing Order; and all said previous findings and determinations are hereby ratified and affirmed, except insofar as such findings and determinations may be in
Pursuant to the provisions of the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), and the applicable rules of practice and procedure effective thereunder (7 CFR part 900), a public hearing was held upon further amendment of Marketing Order No. 982, regulating the handling of hazelnuts grown in Oregon and Washington.
Upon the basis of the record, it is found that:
(1) The Order, as amended, and as hereby further amended, and all of the terms and conditions thereof, would tend to effectuate the declared policy of the Act;
(2) The Order, as amended, and as hereby further amended, regulates the handling of hazelnuts grown in the production area in the same manner as, and is applicable only to, persons in the respective classes of commercial and industrial activity specified in the Order upon which a hearing has been held;
(3) The Order, as amended, and as hereby further amended, is limited in its application to the smallest regional production area that is practicable, consistent with carrying out the declared policy of the Act, and the issuance of several orders applicable to subdivisions of the production area would not effectively carry out the declared policy of the Act;
(4) The Order, as amended, and as hereby further amended, prescribes, insofar as practicable, such different terms applicable to different parts of the production area as are necessary to give due recognition to the differences in the production and marketing of hazelnuts grown in Oregon and Washington; and
(5) All handling of hazelnuts grown in the production area as defined in the Order is in the current of interstate or foreign commerce or directly burdens, obstructs, or affects such commerce.
(b)
(1) Handlers (excluding cooperative associations of growers who are not engaged in processing, distributing, or shipping hazelnuts covered by the order as hereby amended) who, during the period July 1, 2016, through June 30, 2017, handled 50 percent or more of the volume of such hazelnuts covered by said order, as hereby amended, have not signed an amended marketing agreement;
(2) The issuance of this amendatory Order, further amending the aforesaid Order, was favored or approved by at least two-thirds of the growers who participated in a referendum on the question of approval and who, during the period of July 1, 2016, through June 30, 2017 (which has been deemed to be a representative period), have been engaged within the production area in the production of such hazelnuts, such growers having also produced for market at least two-thirds of the volume of such commodity represented in the referendum; and
(3) The issuance of this amendatory Order advances the interests of growers of hazelnuts in the production area pursuant to the declared policy of the Act.
The provisions of the amendments to the Order contained in the Secretary's Decision issued on September 14, 2017, and published in the September 28, 2017, issue of the
Hazelnuts, Marketing agreements, Nuts, Reporting and recordkeeping requirements.
For the reasons set out in the preamble, 7 CFR part 982 is amended as follows:
7 U.S.C. 601-674.
Merchantable hazelnuts means inshell hazelnuts that meet the grade, size, and quality regulations in effect pursuant to § 982.45 and are likely to be available for handling as inshell hazelnuts.
(d) Grade, size, and quality regulations. Prior to September 20, the Board may consider grade, size, and quality regulations in effect and may recommend modifications thereof to the Secretary.
(c)
(d)
(d) Whenever quality regulations are in effect pursuant to § 982.45, each handler shall certify that all product to be handled or credited in satisfaction of a restricted obligation meets the quality regulations as prescribed.
Dated: October 15, 2018.
Federal Housing Finance Agency.
Final rule.
The Federal Housing Finance Agency (FHFA) is amending its regulation on the Responsibilities of Boards of Directors, Corporate Practices, and Corporate Governance for its regulated entities. The final rule amends the existing regulation pertaining to Federal Home Loan Bank strategic business plans so that it applies as well to the Enterprises, and makes a number of adjustments and conforming changes to the existing regulation. As amended, the regulation requires that the board of directors of each regulated entity have in effect at all times a strategic business plan that describes its strategy for achieving its mission and public purposes. It extends to the Enterprise boards the existing provision requiring the board of each Federal Home Loan Bank to review the strategic business plan at least annually, re-adopt it at least once every three years, and establish reporting requirements for and monitor implementation of the strategic business plan. The final rule adds a new provision regarding current and emerging risks, repeals two outdated provisions of the existing regulation, and makes a conforming change to the Office of Finance Board of Directors regulation.
The final rule is effective on December 18, 2018.
Daniel Callis, Principal Risk Analyst, Office of the Chief Accountant, at
On April 6, 2018, FHFA published a proposed rule that would amend the existing FHFA regulation on Responsibilities of Boards of Directors, Corporate Practices and Corporate Governance Matters. The proposed rule would amend, and extend to apply to the board of directors of each Enterprise, the existing provision requiring the board of directors for each Federal Home Loan Bank to have in effect at all times a strategic business plan for the entity. It would also require the strategic business plan to: (1) Articulate measurable operating goals; (2) address credit needs identified through ongoing market research and stakeholder consultations; (3) describe significant activities being planned, including any changes to business strategy; (4) be supported by appropriate and timely research; and (5) identify current and emerging risks, including those associated with the entity's existing activities or new activities. It would also require a board to review the strategic business plan at least annually, re-adopt it at least once every three years, and establish reporting requirements for and monitor implementation of the strategic business plan.
The proposed rule would also repeal two outdated provisions, and make a conforming change to the Office of Finance Board of Directors regulation.
FHFA received comments on the proposed rule from Fannie Mae and Freddie Mac (Enterprises) and U.S. Mortgage Insurers (USMI), a trade association comprising various private mortgage insurance companies. The commenters generally agreed with the establishment of a regulatory requirement for a strategic business plan. Two commenters also argued that a regulated board should be permitted to articulate goals, strategies, and risks at a high level, rather than with granular specificity. Other comments included one concerning the effect that the new activities process and conservatorship have on the strategic business plan process.
The comments are summarized below, along with FHFA's responses and discussion of changes, if any, to the final rule text in consideration of the comments.
The commenters agreed generally with the establishment of a regulatory requirement for a board-approved strategic business plan. The commenters also generally agreed that a strategic business plan should have measurable goals and objectives to hold management accountable.
Commenters differed on the appropriate balance between board flexibility to plan from a high-level perspective and at a more detailed level. Two commenters proposed modifying the final rule to permit a board to articulate goals and strategies at a high level, while one commenter supported requirements on the level of individual activities.
The commenters offered specific suggestions to revise the language of the regulation to permit high-level discussion. With respect to proposed § 1239.14(a)(1)(ii), FHFA received suggestions for the plan to articulate goals and objectives for “strategic activities,” not “for each significant activity and all authorized new activities” as proposed. Another commenter suggested that goals and objectives be articulated for “significant business strategy.”
For proposed § 1239.14(a)(3), one commenter suggested that the requirement should be that the plan describe “significant strategic activities” while another suggested “strategies.” Commenters suggested that the final regulation exclude from strategic planning changes in business strategy not determined “significant.”
For proposed § 1239.14(a)(5), commenters suggested excluding less-than-significant risks from being required to be addressed in the strategic business plan. One commenter
One commenter expressed concern that requiring the plan to address specific activities could be unworkable due to high numbers of Enterprise activities.
In contrast, another commenter supported strategic planning requirements for individual activities, and questioned a threshold prescribing planning only for “significant” activities, because the metric for “significance” remains too broad, and potentially excludes too much from board scrutiny or oversight. This commenter expressed that strategic planning for individual activities and authorized new activities would facilitate a board's monitoring and review of individual activities and market footprint. The same commenter also suggested the rule apply metrics such as stress testing to Enterprise activities to assess their risks.
The management of a regulated entity shall be “by or under the direction” of its board of directors, and the board has “ultimate responsibility” of oversight over the entity, which responsibility may not be delegated to management.
On the other hand, requirements that are too high-level may not provide a board with a sufficient view of the risks of the goals and of strategies deployed to achieve those goals. To support board planning at a meaningful level of involvement, FHFA also declines to modify the rule to permit strategic goals to be articulated at the highest level of generality. FHFA seeks an appropriate balance in the final rule, necessary to support a board's efforts in setting strategic goals, determining a safe and sound strategy to meet those goals, and overseeing execution. The final rule uses a threshold of “significant” activities.
Similarly, the Federal Reserve Board's recent proposed supervisory guidance cited by Freddie Mac provides that a “clear strategy includes sufficient detail to enable senior management to identify the firm's strategic objectives; [and] to create an effective management structure, implementation strategies, plans and budgets for each business line”). 82 FR 37219, 37224 (Aug. 9, 2017). The Federal Reserve Board's proposed guidance thus provides that a strategic plan is expected to communicate to senior management the board's priorities, objectives, and strategies in sufficient detail for senior management to allocate resources appropriately to each business line.
A threshold of “significant” activities would avoid requiring a board to engage with activities that the board does not determine are significant. The rule does not require a board to perform, by itself, every task necessary to determine those activities that are significant. Instead, subject to its duties, a board may set parameters for senior management to apply in identifying activities that the board considers to be significant activities. These parameters could relate to the risks posed by an activity, including whether the activity contributes to or deviates from the entity's strategic goals, statutory mission, and public purposes. They could also relate to any increased scaling of the activity, either planned or in execution.
The final rule does not require specific metrics to address expansion or contraction of activities in response to the entity's mission, public purposes and market assessment. Subject to its duties under applicable law in the absence of specific regulatory requirements, a board will determine, or oversee the determination of, any such appropriate metrics.
The final rule in the opening provision of § 1239.14(a), which establishes a general requirement for a strategic business plan, is revised to require a strategic business plan to describe how the “significant” business activities of the regulated entity will achieve a regulated entity's mission and public purposes. Though FHFA did not receive specific comments to the proposed opening provision of § 1239.14(a), FHFA made the final rule revision to the opening provision based on comments it received on this issue.
The final rule is also revised at § 1239.14(a)(1)(i) and (ii) to state that a board's strategic business plan shall articulate measurable goals and objectives. Also, the proposed reference to “operating” is deleted so that a plan is not required, or limited, to articulate “operating” goals and objectives. Section 1239.14(a)(1)(ii) is revised to clarify that a plan articulate measurable goals and objectives also for “significant” authorized new activities. As a result of this revision, a plan would not be required to address authorized new activities that are not determined to be significant activities. A parallel change was not made to § 1239(a)(1)(i), the provision applying to the Banks. The FHFA regulation covering new business activities process for the Banks already contains a determination that the activity “entails material risks . . .” 12 CFR 1272.1. If FHFA were to amend the regulations regarding Enterprise new activities and new products to include a threshold equivalent to the “significant” activities threshold used in the final rule, FHFA may consider taking a similar approach for the Enterprises in § 1239.14(a)(1)(ii) that it does for the Banks in § 1239.14(a)(1)(i).
At § 1239.14(a)(3), the revised final rule requires a plan to describe any “significant” changes to business strategy that are planned, and not just any change to business strategy. As a result of this revision, a board is not required to address changes to business strategy that the entity is planning to undertake that it does not determine to be significant.
At § 1239.14(a)(5), the revised final rule requires a strategic business plan to identify current and emerging risks associated with the regulated entity's “significant” activities, existing or new. The revised final rule also requires that a plan discuss how the entity intends to address such risks,
FHFA received comments that the proposed rule would impose on the board duties more appropriate for management, and that the final rule should preserve the distinct division of roles between board and management.
The comments arose in the context of the proposed requirements that the strategic business plan discuss credit needs and opportunities identified through market research and stakeholder consultation, and be supported by appropriate and timely research and analysis of relevant market developments. Specific comments suggested that any research and analysis supporting the strategic business plan be as Enterprise management deems appropriate.
The proposed rule at § 1239.14(a)(2) does not affect a board's authority, require the board to conduct market research and stakeholder consultations, or prescribe the manner in which such research and consultation must be conducted. The proposed rule does not prohibit a board from delegating market research and stakeholder consultations, consistent with the board's duties. The final rule adopts § 1239.14(a)(2) as proposed.
Similarly, the proposed rule at § 1239.14(a)(4)(ii) does not require the board to conduct research and analysis of market developments, or prescribe the type of research and analysis. The proposed rule does not affect the board's authority to determine what research and analysis is appropriate to support the plan. Nor does the proposed rule affect the board's authority to assign research to senior management, while overseeing that it is done to the board's satisfaction.
In addition, while Fannie Mae objected to the reference to timely research in § 1239.14(a)(4)(ii), the purpose of that reference is to specify that the supporting research be suitably timed for the plan, and that the research is not stale or expired.
The final rule adopts § 1239.14(a)(4)(ii) as proposed.
FHFA received a comment that the minimum requirements for a strategic business plan adapted from existing requirements applying to the Federal Home Loan Banks are not appropriate for the Enterprises. Specifically, the commenter asserted that, unlike the Banks, the Enterprises are SEC-registered, publicly-traded, and operating under New York Stock Exchange requirements. The commenter further noted that the Enterprises are larger than the Banks and securitize mortgages as their core business model.
FHFA received a comment that the final rule should not apply to diversity and inclusion strategic plans, which are addressed specifically by 12 CFR 1223.21(b), (d), and (e).
The commenters also differed on whether the strategic business plan should address current and emerging risks. With respect to proposed § 1239.14(a)(5), FHFA received a comment that, while current risks may be ascertainable, emerging risks may not be knowable at the outset of a multi-year strategic planning process. Another commenter expressed support for a requirement that the strategic business plan address current and emerging risks.
With the revision discussed above at II.B., the final rule otherwise adopts, as proposed, the provision on emerging risks and furthering the entity's public purposes and mission in a safe and sound manner.
A commenter asked how conservatorship and 12 CFR part 1253 (Prior Approval for Enterprise Products) affects the final rule, how FHFA views the relationship between its conservatorship and regulatory obligations, and how its processes and decisions regarding activities and products are consistent with FHFA's role as conservator. A commenter suggested that FHFA issue guidance on how the final rule would apply to “significant activities” in light of 12 CFR part 1253.
Separately, pursuant to its conservatorship authority, FHFA has provided for Enterprise boards to exercise the functions of management oversight that exist under applicable law and regulation, including FHFA's corporate governance regulation at 12 CFR part 1239. Although the Enterprises remain in conservatorship, their boards of directors have been operating under FHFA regulations, including most recently 12 CFR part 1239, that govern board members outside of conservatorship, except as modified by the conservator. Therefore, under this final rule, the board of directors at each Enterprise is required to adopt and have in effect a strategic business plan.
The Enterprise new activities process (12 CFR part 1253) and the final rule both reference “new activity.” However, they use the term for different supervisory purposes. Part 1253 defines new activities inclusively to support determination of new products, while the final rule establishes strategic plan requirements involving “significant” new activities, which is a smaller subset of new activities. In addition, the Enterprise new activities process is separate from the strategic business plan process. For example, the Enterprise new activities process may result in the review and authorization of new activities that are not required to be addressed in the strategic business plan because the board does not determine them significant. Similarly, a strategic business plan may address significant activities that are not new activities.
The availability or denial of individual new activities may augment or limit a regulated entity's tools for meeting its chosen strategic goals. A strategic business plan could help identify significant activities on which the regulated entity plans to rely to achieve its strategic goals. It could also help identify alternative strategies that may be safer and more effective, and to explain the role, relevance, and risks of significant activities that the regulated entity is planning to undertake.
However, FHFA decisions relating to new activities do not affect a board's
The final rule retains the general requirement for a strategic business plan to address activities the board determines significant. Clarifying revisions are made to specific provisions.
In addition, the final rule requires a strategic business plan to articulate measurable goals, address credit needs and market opportunities, describe significant activities being planned including significant changes in business strategy, be supported by appropriate and timely research, and identify current and emerging risks. It also requires a board to review the strategic business plan at least annually, re-adopt it at least once every three years, and establish reporting requirements for and monitor implementation of the strategic business plan. The final rule also repeals two outdated provisions that required Bank strategic business plans to include quantitative performance goals for Bank products related to multifamily housing and to community financial institution collateral, and that required related reporting. It also makes a conforming change to the Office of Finance Board of Directors regulation.
When promulgating regulations that relate to the Banks, section 1313(f) of the Safety and Soundness Act requires FHFA to consider the differences between the Banks and the Enterprises with respect to the Banks' cooperative ownership structure, mission of
The final rule does not contain any collections of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Regulatory Flexibility Act (5 U.S.C. 601
In accordance with the Congressional Review Act, FHFA has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of the Office of Management and Budget (OMB).
Administrative practice and procedure, Federal home loan banks, Government-sponsored enterprises, Reporting and recordkeeping requirements.
Federal home loan banks, Securities.
Accordingly, for reasons stated in the Supplementary Information, FHFA hereby amends parts 1239 and 1273 of chapter XII of title 12 of the Code of Federal Regulations as follows:
12 U.S.C. 1426, 1427, 1432(a), 1436(a), 1440, 4511(b), 4513(a), 4513(b), 4526, and 15 U.S.C. 78oo(b).
(a)
(1)(i) In the case of a Bank, articulate measurable goals and objectives for each significant business activity and for all authorized new business activities, which must include plans for maximizing activities that further the Bank's housing finance and community lending mission, consistent with part 1265 of this chapter;
(ii) In the case of an Enterprise, articulate measurable goals and objectives for each significant existing activity and for significant authorized new activities;
(2) Discuss how the regulated entity will address credit needs and market opportunities identified through ongoing market research and stakeholder consultations;
(3) Describe any significant activities in which the regulated entity is planning to be engaged, including any significant changes to business strategy or approach that the regulated entity is planning to undertake, and discuss how such activities would further the regulated entity's mission and public purposes;
(4)(i) In the case of a Bank, be supported by appropriate and timely research and analysis of relevant market developments and member and housing associate demand for Bank products and services;
(ii) In the case of an Enterprise, be supported by appropriate and timely research and analysis of relevant market developments; and
(5) Identify current and emerging risks associated with the regulated entity's significant existing activities or new activities, and discuss how the regulated entity plans to address such risks while furthering its public purposes and mission in a safe and sound manner.
(b)
(1) Review the regulated entity's strategic business plan at least annually;
(2) Re-adopt the strategic business plan for the regulated entity at least every three years; and
(3) Establish management reporting requirements and monitor implementation of the strategic business plan and the goals and objectives contained therein.
12 U.S.C. 1431, 1440, 4511(b), 4513, 4514(a), 4526(a).
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
This action extends, with modifications to reflect changed conditions in specified areas of Ukraine, the Special Federal Aviation Regulation (SFAR) prohibiting certain flight operations in the Simferopol Flight Information Region (FIR) (UKFV) and Dnipropetrovsk Flight Information Region (FIR) (UKDV) by all: U.S. air carriers; U.S. commercial operators; persons exercising the privileges of an airman certificate issued by the FAA, except when such persons are operating U.S.-registered aircraft for a foreign air
This final rule is effective on October 19, 2018.
Michael Filippell, Air Transportation Division, Flight Standards Service, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone 202-267-8166; email
This action extends, with modification to reflect changed conditions in Ukraine, the prohibition against U.S. civil flight operations in specified areas of the Simferopol Flight Information Region (FIR) (UKFV) and Dnipropetrovsk Flight Information Region (FIR) (UKDV) by all U.S. air carriers; U.S. commercial operators; persons exercising the privileges of an airman certificate issued by the FAA, except when such persons are operating U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except where the operator of such aircraft is a foreign air carrier, from October 27, 2018, until October 27, 2020. The FAA assesses that security and safety conditions have sufficiently stabilized in certain regions of Ukraine, thereby reducing the area of hazard to U.S. civil aviation in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV). However, the FAA finds an extension of the prohibition is necessary in other specified areas of Ukraine to safeguard against continuing hazards to civil aviation. The new boundaries of the prohibition are described in the preamble to this final rule. In this action, the FAA retains the lateral limits of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV), for reference as definitions in new paragraph (f) of the final rule.
The FAA is responsible for the safety of flight in the U.S. and for the safety of U.S. civil operators, U.S.-registered civil aircraft, and U.S.-certificated airmen throughout the world. The FAA Administrator's authority to issue rules on aviation safety is found in title 49, U.S. Code, Subtitle I, sections 106(f) and (g). Subtitle VII of title 49, Aviation Programs, describes in more detail the scope of the agency's authority. Section 40101(d)(1) provides that the Administrator shall consider in the public interest, among other matters, assigning, maintaining, and enhancing safety and security as the highest priorities in air commerce. Section 40105(b)(1)(A) requires the Administrator to exercise this authority consistently with the obligations of the U.S. Government under international agreements.
This rulemaking is promulgated under the authority described in title 49, U.S. Code, Subtitle VII, Part A, subpart III, section 44701, General requirements. Under that section, the FAA is charged broadly with promoting safe flight of civil aircraft in air commerce by prescribing, among other things, regulations and minimum standards for practices, methods, and procedures that the Administrator finds necessary for safety in air commerce and national security.
This regulation is within the scope of FAA's authority, because it continues to prohibit the persons described in paragraph (a) of SFAR No. 113, 14 CFR 91.1607, from conducting flight operations in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV) due to the continuing hazards to the safety of U.S. civil flight operations in certain regions of Ukraine, as described in the preamble to this final rule.
The FAA also finds that this action is fully consistent with the obligations under 49 U.S.C. 40105(b)(1)(A) to ensure that the FAA exercises its duties consistently with the obligations of the United States under international agreements.
Section 553(b)(3)(B) of title 5, U.S. Code, authorizes agencies to dispense with notice and comment procedures for rules when the agency for “good cause” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Section 553(d) also authorizes agencies to forgo the delay in the effective date of the final rule for good cause found and published with the rule. In this instance, the FAA finds good cause to forgo notice and comment because notice and comment would be impracticable and contrary to the public interest. In addition, it is contrary to the public interest to delay the effective date of this SFAR.
The FAA has identified an ongoing need to maintain the flight prohibition in certain specified areas of Ukraine due to continued safety of flight hazards associated with both Ukraine and Russia air navigation service providers (ANSPs) claiming control of airspace over portions of the Simferopol FIR (UKFV) and due to the ongoing conflict with localized skirmishes within the eastern portion of the Dnipropetrovsk FIR (UKDV). These hazards are further described in the preamble to this rule. To the extent that the rule is based upon classified information, such information is not permitted to be shared with the general public. Also, threats to U.S. civil aviation can evolve rapidly. As a result, the agency's original proposal could become unsuitable for minimizing the hazards to U.S. civil aviation in the affected airspace during or after the notice and comment process. For these reasons, the FAA finds good cause to forgo notice and comment and any delay in the effective date for this rule.
The FAA first published SFAR No. 113, § 91.1607, on April 25, 2014, to prohibit certain flight operations in a portion of the Simferopol FIR (UKFV) by all: U.S. air carriers; U.S. commercial operators; persons exercising the privileges of an airman certificate issued by the FAA, except when such persons are operating U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except where the operator of such aircraft is a foreign air carrier.
On July 18, 2014, the FAA issued a Notice to Airmen (NOTAM) FDC4/2182, expanding the flight prohibition to the entire Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV), primarily as an immediate response to the shoot-down of Malaysia Airlines flight MH17 on July 17, 2014, while flying over Ukraine at 33,000 feet just west of the Russian border. The FAA determined that the ongoing conflict in the region posed a significant threat to U.S. civil aviation operations in these FIRs. The
The flight safety concern for the Simferopol FIR (UKFV) at that time was demonstrated by an European Aviation Safety Agency Safety Information Bulletin on February 17, 2016, indicating that ATS routes L851 and M856 could be considered for planning flights in the Simferopol FIR (UKFV), and subsequent Russian Federal Air Transport Agency response in which it asserted that it was responsible for air traffic services in a portion of the Simferopol FIR (UKFV).
Separately, in the Dnipropetrovsk FIR (UKDV), the FAA noted that there was an ongoing risk of skirmishes in the area and a potential for larger-scale fighting in eastern Ukraine involving combined Russian-separatist forces, which could result in civil aircraft being misidentified as a threat and then intercepted or otherwise engaged. In the 2016 final rule, the FAA identified that these combined forces had access to a variety of anti-aircraft weapons, to include man-portable air defense systems (MANPADS) and possibly more advanced surface-to-air missiles (SAMs) that had the capability to engage aircraft at higher altitudes.
Since the 2016 final rule, the FAA assesses that security and safety conditions have sufficiently stabilized in certain regions of Ukraine, thereby reducing the area of impacted airspace in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV) and is revising the flight prohibition to allow U.S. civil flights to resume in certain areas. However, the FAA finds an extension of the prohibition is necessary in other specified areas of Ukraine to safeguard against continuing hazards to civil aviation.
Since 2014, the FAA has prohibited operations within the Simferopol FIR (UKFV) by all U.S. civil operators and airmen, in part, due to continuing flight safety concerns regarding the risk of pilots being given conflicting ANSP guidance within the Simferopol FIR (UKFV). Specifically, in 2014, the Russian Federation annexed the Crimean Peninsula and claimed ANSP authority over the Simferopol FIR (UKFV), including airspace over the Black Sea, and deployed a substantial military force to the Peninsula, including advanced weapon capabilities to enforce their territorial and airspace claims for portions of the Simferopol FIR (UKFV). Since that time, the Russian Federation has claimed authority over the entire Simferopol FIR (UKFV) and continues to assert authority over the Crimean Peninsula and adjacent waters. However, the International Civil Aviation Organization (ICAO) and other countries do not support these assertions by the Russian Federation and recognize the Ukrainian State Air Traffic Service Enterprise as the ANSP with authority over the Simferopol FIR (UKFV).
The previous flight safety concerns for conflicting ANSP guidance for the Black Sea air routes at a distance offshore from the Peninsula within portions of the Simferopol FIR (UKFV) have been addressed by the government of Ukraine. Since the FAA extended the prohibition in SFAR No. 113, § 91.1607, in 2016, the government of Ukraine has established, via its aeronautical information publication (AIP), a restricted airspace area over the Crimean Peninsula and the adjacent territorial sea. In addition, the government of Ukraine has issued flight advisories, prohibitions and other instructions for the safe navigation of civil aircraft, which are published via NOTAMs,
Nevertheless, the government of Ukraine has not mitigated the hazards in all of the Simferopol FIR (UKFV) necessitating a continuing, albeit more limited, flight prohibition. An overwhelming Russian military presence and weapon capabilities continue to be located on the Crimean Peninsula, creating a continuing risk for misidentification of aircraft flying over the Peninsula and in the airspace near the Peninsula. Additionally, Ukraine and Russia continue to assert competing claims of the airspace. For those reasons, and their attendant risk to U.S. civil aircraft operations, the FAA is continuing to prohibit operations by U.S. civil operators and airmen in the Simferopol FIR (UKFV) from the surface to unlimited north and northeast of a line drawn direct from SOBLO (431503N 362298E) to DOLOT (434214N 332819E), direct to SOROK (440628N 324260E), then direct to OTPOL (452738N 313064E). The use of airway M747, which partially overlaps with the line of demarcation for the area of prohibition, is also prohibited. The remaining area of prohibition includes a sufficient buffer from the continuing
In the Dnipropetrovsk FIR (UKDV) there continues to be an inadvertent risk to civil aviation associated with the ongoing conflict, which involves localized skirmishes and the potential for larger scale fighting in the eastern portion of the Dnipropetrovsk FIR (UKDV). These skirmishes and a risk for potential larger-scale fighting could lead to the misidentification and/or engagement of civil aviation by separatist air defense forces, as demonstrated by the shoot-down of Malaysia Airlines flight MH17 on July 17, 2014. The majority of military engagements have been in close proximity to the line of conflict in the eastern portion of the Dnipropetrovsk FIR (UKDV). The various military and militia elements in that region have access to a variety of anti-aircraft weapons systems to include MANPADS and possibly more advanced SAMs that have the capability to engage aircraft at higher altitudes. Separatists have demonstrated their ability to use these anti-aircraft weapons by successfully shooting down a number of aircraft during the course of the fighting in eastern Ukraine in 2014. Organization for Security and Cooperation in Europe Special Monitoring Mission to Ukraine unmanned aircraft systems continue to be shot down by SAMs and small arms ground fire, and brought down with GPS jamming in the eastern portion of the Dnipropetrovsk FIR (UKDV).
These threats are concentrated in the eastern portion of the Dnipropetrovsk FIR (UKDV) within the pro-Russian separatist enclave and in close proximity to the line of control that borders the enclave. The anti-aircraft weapons capabilities and deployments of forces associated with the pro-Russian separatists are limited at this time to within the eastern portion of the Dnipropetrovsk FIR (UKDV). While the potential for fluctuating levels of military engagement continues along the line of control in eastern portions of the Dnipropetrovsk FIR (UKDV), the military conflict has begun to stabilize, which reduces the risk of a larger-scale conflict that might extend into the western portion of the Dnipropetrovsk FIR (UKDV). This results in a reduced risk to civil aviation in the western portion of the Dnipropetrovsk FIR (UKDV), and the FAA is relaxing the area of prohibition to account for the reduced risk.
Therefore, due to the continued threats in the eastern portion of the Dnipropetrovsk FIR (UKDV), the FAA is continuing to prohibit operations by U.S. civil operators and airmen in the Dnipropetrovsk FIR (UKDV) from the surface to unlimited east of a line drawn direct from ABDAR (471802N 351732E) along airway M853 to NIKAD (485946N 355519E), then along airway N604 to GOBUN (501806N 373824E). The use of airways M853 and N604, which partially overlap with the line of demarcation for the prohibition, is also prohibited. This revised area of prohibition includes a sufficient buffer between the conflict region along the Ukraine-Russia border, including known weapons that may be threats to aviation, and the portions of the Dnipropetrovsk FIR (UKDV) where U.S. civil flights are permitted to resume.
Based on the reduced scope of the prohibition, U.S. operators and airmen are permitted to conduct operations in the western portions of the Dnipropetrovsk FIR (UKDV) from the surface to unlimited west of a line drawn direct from ABDAR (471802N 351732E) along airway M853 to NIKAD (485946N 355519E), then along airway N604 to GOBUN (501806N 373824E), which previously had been prohibited.
In addition, due to the relatively close proximity of the approach and departure routes of three airports to the new boundary of the prohibition flight area, the FAA has added an exception for takeoffs and landings. This exception permits operations within the flight prohibition area of the Dnipropetrovsk FIR (UKDV), to the extent necessary to takeoff and land at three specified airports, subject to the approval of, and in accordance with the conditions established by, the appropriate authorities of Ukraine: Kharkiv International Airport (UKHH); Dnipropetrovsk International Airport (UKDD); and Zaporizhzhia International Airport (UKDE). The FAA has determined these operations can be conducted with minimal additional risk due to the sufficient distance provided by the specified prohibition boundary line as a buffer from the area of fighting and associated weapons capabilities.
Therefore, as a result of the significant continuing risk to the safety of U.S. civil aviation in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV), the FAA extends the expiration date of SFAR No. 113, 14 CFR 91.1607, from October 27, 2018, to October 27, 2020, to maintain the prohibition on flight operations in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV) by: All U.S. air carriers; U.S. commercial operators; persons exercising the privileges of an airman certificate issued by the FAA, except when such persons are operating U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except where the operator is a foreign air carrier. While the FAA's flight prohibition does not apply to foreign air carriers, DOT codeshare authorizations prohibit foreign air carriers from carrying a U.S. codeshare partner's code on a flight segment that operates in airspace for which the FAA has issued a flight prohibition. The FAA is also retaining the lateral limits of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV), which are recognized by ICAO, for reference as definitions in new paragraph (f) of the final rule.
The FAA will continue to actively monitor the situation and evaluate the extent to which U.S. civil operators and airmen may be able to operate safely in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV). Amendments to SFAR No. 113, § 91.1607, may be appropriate if the risk to aviation safety and security changes. The FAA may amend or rescind SFAR No. 113, § 91.1607, as necessary, prior to its expiration date.
The FAA is incorporating minor editorial changes for clarifying purposes in § 91.1609, including correcting the title of the FIR and clarifying the procedure for considering approval and exemption requests. These changes are consistent with other recently published SFARs. The FAA is also republishing the details concerning the approval and exemption processes in Sections V and VI of this preamble so that interested persons will be able to refer to this final rule for all relevant information regarding SFAR No. 113.
In some instances, U.S. Government departments, agencies, or instrumentalities may need to engage U.S. civil aviation to support their activities in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV). The FAA is revising the approval process for SFAR No. 113, § 91.1607, to make it consistent with the approval process of more recently published flight prohibition SFARs. If a department, agency, or instrumentality of the U.S. Government determines that it has a
An approval request must be made directly by the requesting department, agency, or instrumentality of the U.S. Government to the FAA's Associate Administrator for Aviation Safety in a letter signed by an appropriate senior official of the requesting department, agency, or instrumentality. The FAA will not accept or process requests for approval by anyone other than the requesting department, agency, or instrumentality. In addition, the senior official signing the letter requesting FAA approval on behalf of the requesting department, agency, or instrumentality must be sufficiently highly placed within the organization to demonstrate that the senior leadership of the requesting department, agency, or instrumentality supports the request for approval and is committed to taking all necessary steps to minimize operational risks to the proposed flights. The senior official must also be in a position to: (1) Attest to the accuracy of all representations made to the FAA in the request for approval and (2) ensure that any support from the requesting U.S. Government department, agency, or instrumentality described in the request for approval is in fact brought to bear and is maintained over time. Unless justified by exigent circumstances, requests for approval must be submitted to the FAA no less than 30 calendar days before the date on which the requesting department, agency, or instrumentality wishes the proposed operations to commence.
The letter must be sent to the Associate Administrator for Aviation Safety, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591. Electronic submissions are acceptable, and the requesting entity may request that the FAA notify it electronically as to whether the approval request is granted. If a requestor wishes to make an electronic submission to the FAA, the requestor should contact the Air Transportation Division, Flight Standards Service, at (202) 267-8166, to obtain the appropriate email address. A single letter may request approval from the FAA for multiple persons covered under SFAR No. 113, § 91.1607, and/or for multiple flight operations. To the extent known, the letter must identify the person(s) expected to be covered under the SFAR on whose behalf the U.S. Government department, agency, or instrumentality is seeking FAA approval, and it must describe—
• The proposed operation(s), including the nature of the mission being supported;
• The service to be provided by the person(s) covered by the SFAR;
• To the extent known, the specific locations in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV) where the proposed operation(s) will be conducted, including, but not limited to, the flight path and altitude of the aircraft while it is operating in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV) and the airports, airfields and/or landing zones at which the aircraft will take-off and land; and
• The method by which the department, agency, or instrumentality will provide, or how the operator will otherwise obtain, current threat information and an explanation of how the operator will integrate this information into all phases of the proposed operations (
The request for approval must also include a list of operators with whom the U.S. Government department, agency, or instrumentality requesting FAA approval has a current contract(s), grant(s), or cooperative agreement(s) (or its prime contractor has a subcontract(s)) for specific flight operations in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV). Additional operators may be identified to the FAA at any time after the FAA approval is issued. However, all additional operators must be identified to, and obtain an Operations Specification (OpSpec) or Letter of Authorization (LOA), as appropriate, from the FAA for operations in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV), before such operators commence such operations. The approval conditions discussed below apply to any such additional operators. Updated lists should be sent to the email address to be obtained from the Air Transportation Division, by calling (202) 267-8166.
If an approval request includes classified information, requestors may contact Aviation Safety Inspector Michael Filippell for instructions on submitting it to the FAA. His contact information is listed in the
FAA approval of an operation under SFAR No. 113, § 91.1607, does not relieve persons subject to this SFAR of their responsibility to comply with all applicable FAA rules and regulations. Operators of civil aircraft must comply with the conditions of their certificate, OpSpecs, and LOAs, as applicable. Operators must also comply with all rules and regulations of other U.S. Government departments or agencies that may apply to the proposed operation(s), including, but not limited to, regulations issued by the Transportation Security Administration.
If the FAA approves the request, the FAA's Aviation Safety Organization will send an approval letter to the requesting department, agency, or instrumentality informing it that the FAA's approval is subject to all of the following conditions:
(1) The approval will stipulate those procedures and conditions that limit, to the greatest degree possible, the risk to the operator, while still allowing the operator to achieve its operational objectives.
(2) Before any approval takes effect, the operator must submit to the FAA:
(a) A written release of the U.S. Government from all damages, claims, and liabilities, including without limitation legal fees and expenses, relating to any event arising out of or related to the approved operations in the Simferopol FIR (UKFV) and/or Dnipropetrovsk FIR (UKDV); and
(b) The operator's written agreement to indemnify the U.S. Government with respect to any and all third-party damages, claims, and liabilities, including without limitation legal fees and expenses, relating to any event arising from or related to the approved operations in specified areas of the Simferopol FIR (UKFV) and/or Dnipropetrovsk FIR (UKDV).
(3) Other conditions that the FAA may specify, including those that may be imposed in OpSpecs or LOAs, as applicable.
The release and agreement to indemnify do not preclude an operator from raising a claim under an applicable non-premium war risk insurance policy issued by the FAA under chapter 443 of title 49, U.S. Code.
If the FAA approves the proposed operation(s), the FAA will issue an OpSpec or LOA, as applicable, to the operator(s) identified in the original request authorizing it to conduct the approved operation(s), and will notify
Any operations not conducted under an approval issued by the FAA through the approval process set forth previously must be conducted under an exemption from SFAR No. 113, § 91.1607. A petition for exemption must comply with 14 CFR part 11 and requires exceptional circumstances beyond those contemplated by the approval process set forth previously. In addition to the information required by 14 CFR 11.81, at a minimum, the requestor must describe in its submission to the FAA—
• The proposed operation(s), including the nature of the operation;
• The service to be provided by the person(s) covered by the SFAR;
• The specific locations in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV) where the proposed operation(s) will be conducted, including, but not limited to, the flight path and altitude of the aircraft while it is operating in specified areas of the Simferopol FIR (UKFV) and Dnipropetrovsk FIR (UKDV) and the airports, airfields and/or landing zones at which the aircraft will take-off and land;
• The method by which the operator will obtain current threat information, and an explanation of how the operator will integrate this information into all phases of its proposed operations (
• The plans and procedures that the operator will use to minimize the risks, identified in the preamble of this rule, to the proposed operations, so that granting the exemption would not adversely affect safety or would provide a level of safety at least equal to that provided by this SFAR. The FAA has found comprehensive, organized plans and procedures of this nature to be helpful in facilitating the agency's safety evaluation of petitions for exemption from flight prohibition SFARs.
Additionally, the release and agreement to indemnify, as referred to previously, are required as a condition of any exemption that may be issued under SFAR No. 113, § 91.1607.
The FAA recognizes that operations that may be affected by SFAR No. 113, § 91.1607, may be planned for the governments of other countries with the support of the U.S. Government. While these operations will not be permitted through the approval process, the FAA will consider exemption requests for such operations on an expedited basis and prior to any private exemption requests.
Changes to Federal regulations must undergo several economic analyses. First, Executive Orders 12866 and 13563 direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as codified in 5 U.S.C. 603
In conducting these analyses, the FAA has determined that this final rule has benefits that justify its costs. This rule is a significant regulatory action, as defined in section 3(f) of Executive Order 12866, as it raises novel policy issues contemplated under that Executive Order. As notice and comment under 5 U.S.C. 553 are not required for this final rule, the regulatory flexibility analyses described in 5 U.S.C. 603 and 604 regarding impacts on small entities are not required. This rule will not create unnecessary obstacles to the foreign commerce of the United States. This rule will not impose an unfunded mandate on State, local, or tribal governments, or on the private sector, by exceeding the threshold identified previously.
On April 25, 2014, the FAA published SFAR No. 113 prohibiting flight operations in part of the Simferopol FIR (UKFV) by U.S. air carriers and airmen because of conflicting airspace claims between Ukraine and the Russian Federation owing to the Russian annexation of the Crimean Peninsula. The FAA expanded this prohibition to the entire Simferopol FIR (UKFV) and also to the Dnipropetrovsk FIR (UKDV), first by NOTAM (July 18, 2014 (UTC)) and then by rule (79 FR 77857, December 29, 2014), owing to conflict between Ukraine military forces and pro-Russian separatists. On October 27, 2015 (80 FR 65621) and October 27, 2016 (81 FR 74671), the FAA further extended this prohibition. The FAA now proposes to extend the prohibition for another two years, but only for portions of the Simferopol (UKFV) and Dnipropetrovsk (UKDV) FIRs where there is a continuing hazard to civil aviation. The FAA is extending the prohibition against U.S. civil operations over the Crimean peninsula in the Simferopol FIR (UKFV), but is permitting U.S. civil operations over four Black Sea routes, sufficiently offshore from the Crimea Peninsula, and over the high seas, due to a stabilization in the security conditions on these routes. In addition, the FAA is extending the prohibition in the eastern part of the Dnipropetrovsk FIR (UKDV), but is permitting U.S. civil operations from the surface to unlimited in the western portion of the Dnipropetrovsk FIR (UKDV). The FAA is also permitting, by exception, takeoffs and landings at three Ukrainian international airports due to proximity of the arrival and departure routes to the area of prohibition within the Dnipropetrovsk FIR (UKDV).
As was noted in the most recent previous amendment to SFAR No. 113, § 91.1607 (81 FR 74671, October 27, 2016), almost all U.S. operators already had voluntarily ceased their operations in these FIRs prior to the issuance of the FAA NOTAM on July 18, 2014 (UTC), which prohibited U.S. civil flight operations in these two FIRs in their entirety. Owing to the continuing hazards to civil flight operations outlined in the preamble, the FAA believes that few, if any, U.S. operators presently seek to conduct operations in the eastern portion of the Dnipropetrovsk FIR (UKDV), or over the Crimean peninsula within the Simferopol FIR (UKFV) in which the FAA continues to prohibit U.S. operations. The FAA notes that since April 25, 2014, when U.S. operators and
As noted in the sections above, the Ukraine ANSP has implemented risk mitigation measures to address safety hazards over the Black Sea routes and on the high seas. These measures have resulted in a significant decrease in safety-related hazards in that part of the Simferopol FIR (UKFV) as shown by over two years of safe flight operations by non-U.S. civil operators on the Black Sea air routes. In the Dnipropetrovsk FIR (UKDV), the deployments of forces associated with the pro-Russian separatists are at this time limited to the eastern part, reducing the risk of a larger-scale conflict that might extend into the western portion of the Dnipropetrovsk FIR (UKDV) and thereby reducing risk to U.S. civil aviation in the western portion. The FAA believes that lifting the prohibition on U.S. civil operations in those parts of the two FIRs will be socially cost-beneficial because it may result in the resumption of safe U.S. civil operations.
The Regulatory Flexibility Act, in 5 U.S.C. 603, requires an agency to prepare an initial regulatory flexibility analysis describing impacts on small entities whenever an agency is required by 5 U.S.C. 553, or any other law, to publish a general notice of proposed rulemaking for any proposed rule. Similarly, 5 U.S.C. 604 requires an agency to prepare a final regulatory flexibility analysis when an agency issues a final rule under 5 U.S.C. 553, after being required by that section or any other law to publish a general notice of proposed rulemaking. The FAA found good cause to forgo notice and comment and any delay in the effective date for this rule. As notice and comment under 5 U.S.C. 553 are not required in this situation, the regulatory flexibility analyses described in 5 U.S.C. 603 and 604 are not required.
The Trade Agreements Act of 1979 (Pub. L. 96-39) prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to this Act, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards.
The FAA has assessed the potential effect of this final rule and determined that its purpose is to protect the safety of U.S. civil aviation from hazards to their operations in the eastern part of the Dnipropetrovsk FIR (UKDV) and over specified areas of the Crimean Peninsula within the Simferopol FIR (UKFV), locations outside the U.S. Therefore, the rule is in compliance with the Trade Agreements Act of 1979.
Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $155.0 million in lieu of $100 million.
This final rule does not contain such a mandate. Therefore, the requirements of Title II of the Act do not apply.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. The FAA has determined that there is no new requirement for information collection associated with this immediately adopted final rule.
In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA's policy to conform to ICAO Standards and Recommended Practices to the maximum extent practicable. The FAA has determined that there are no ICAO Standards and Recommended Practices that correspond to this regulation.
The FAA has analyzed this action under Executive Order 12114, Environmental Effects Abroad of Major Federal Actions (44 FR 1957, January 4, 1979), and DOT Order 5610.1C, Paragraph 16. Executive Order 12114 requires the FAA to be informed of environmental considerations and take those considerations into account when making decisions on major Federal actions that could have environmental impacts anywhere beyond the borders of the United States. The FAA has determined that this action is exempt pursuant to Section 2-5(a)(i) of Executive Order 12114 because it does not have the potential for a significant effect on the environment outside the United States.
In accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 8-6(c), FAA has prepared a memorandum for the record stating the reason(s) for this determination; this memorandum has been placed in the docket for this rulemaking.
The FAA has analyzed this rule under the principles and criteria of Executive Order 13132, Federalism. The agency has determined that this action would not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, would not have Federalism implications.
The FAA analyzed this rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). The agency has determined that it would not be a “significant energy action” under the executive order and would not be likely to have a significant adverse effect on the supply, distribution, or use of energy.
Executive Order 13609, Promoting International Regulatory Cooperation,
This rule is not subject to the requirements of E.O. 13771 (82 FR 9339, Feb. 3, 2017) because it is issued with respect to a national security function of the United States.
An electronic copy of a rulemaking document may be obtained from the internet by—
• Searching the Federal Document Management System (FDMS) Portal (
• Visiting the FAA's Regulations and Policies web page at
• Accessing the Government Publishing Office's web page at
Copies may also be obtained by sending a request (identified by amendment or docket number of this rulemaking) to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW, Washington, DC 20591, or by calling (202) 267-9677.
Except for classified material, all documents the FAA considered in developing this rule, including economic analyses and technical reports, may be accessed from the internet through the Federal Document Management System Portal referenced previously.
The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) (Pub. L. 104-121) (set forth as a note to 5 U.S.C. 601) requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document may contact its local FAA official, or the persons listed under the
Air traffic control, Aircraft, Airmen, Airports, Aviation safety, Freight, Ukraine.
In consideration of the foregoing, the Federal Aviation Administration amends chapter I of title 14, Code of Federal Regulations, part 91, as follows:
49 U.S.C. 106(f), 106(g), 106(g), 1155, 40101, 40103, 40105, 40113, 40120, 44101, 44111, 44701, 44704, 44709, 44711, 44712, 44715, 44716, 44717, 44722, 46306, 46315, 46316, 46504, 46506-46507, 47122, 47508, 47528-47531, 47534, Pub. L. 114-190, 130 Stat. 615 (49 U.S.C. 44703 note); articles 12 and 29 of the Convention on International Civil Aviation (61 Stat. 1180), (126 Stat. 11).
(a)
(1) All U.S. air carriers and U.S. commercial operators;
(2) All persons exercising the privileges of an airman certificate issued by the FAA, except when such persons are operating U.S.-registered aircraft for a foreign air carrier; and
(3) All operators of U.S.-registered civil aircraft, except where the operator of such aircraft is a foreign air carrier.
(b)
(1) Operations within the Simferopol FIR (UKFV) are prohibited from the surface to unlimited, north and northeast of a line drawn direct from SOBLO (431503N 362298E) to DOLOT (434214N 332819E), direct to SOROK (440628N 324260E), then direct to OTPOL (452738N 313064E). This prohibition applies to airway M747.
(2) Operations within the Dnipropetrovsk FIR (UKDV) are prohibited from the surface to unlimited, east of a line drawn direct from ABDAR (471802N 351732E) along airway M853 to NIKAD (485946N 355519E), then along airway N604 to GOBUN (501806N 373824E). This prohibition applies to airways M853 and N604.
(c)
(1) Operations are permitted within the flight prohibition area of the Dnipropetrovsk Flight Information Region (FIR) (UKDV), as described in paragraph (b)(2) of this section, to the extent necessary to takeoff and land at the following three airports, subject to the approval of, and in accordance with the conditions established by, the appropriate authorities of Ukraine:
(i) Kharkiv International Airport (UKHH);
(ii) Dnipropetrovsk International Airport (UKDD); and
(iii) Zaporizhzhia International Airport (UKDE).
(2) Operations are permitted within the flight prohibition areas described in paragraph (b)(1) or (2) of this section provided that such flight operations are conducted under a contract, grant, or cooperative agreement with a department, agency, or instrumentality of the U.S. Government (or under a subcontract between the prime contractor of the department, agency, or instrumentality and the person described in paragraph (a) of this section) with the approval of the FAA, or under an exemption issued by the FAA. The FAA will consider requests for approval or exemption in a timely manner, with the order of preference being: first, for those operations in support of U.S. Government-sponsored activities; second, for those operations in support of government-sponsored activities of a foreign country with the support of a U.S. Government department, agency, or instrumentality; and third, for all other operations.
(d)
(e)
(f)
(2) The Dnipropetrovsk FIR (UKDV) is defined as that airspace from the surface to unlimited within the following lateral limits:
Securities and Exchange Commission.
Interim final temporary rule.
We are adopting interim final temporary rules for issuers subject to reporting obligations pursuant to Regulation Crowdfunding and Regulation A in order to address the needs of companies directly or indirectly affected by Hurricane Michael. The temporary rules extend the filing deadlines for specified reports and forms due pursuant to Regulation Crowdfunding and Regulation A for certain issuers.
These rules are effective from October 19, 2018 through November 23, 2018, except that amendatory instruction 1 revising the authority citation of part 227 is effective October 19, 2018.
Jennifer Zepralka, Office Chief, or Amy Reischauer, Special Counsel, Office of Small Business Policy, Division of Corporation Finance, at (202) 551-3460, U.S. Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-3628.
We are adopting amendments to 17 CFR 227.202 (“Rule 202”) of Regulation Crowdfunding
On October 10, 2018, Hurricane Michael made landfall on the Florida Panhandle. The storm and subsequent flooding have displaced individuals and businesses and disrupted communications and transportation across the affected region. We are adopting these interim final temporary rules to address the needs of companies directly or indirectly affected by Hurricane Michael or its aftermath that are subject to reporting obligations pursuant to Regulation Crowdfunding or Regulation A.
Section 28 of the Securities Act provides that the Commission may, by rule or regulation, “conditionally or unconditionally exempt any person, security, or transaction, or any class or classes of persons, securities, or transactions, from any provision or provisions of this title or of any rule or regulation issued under this title, to the extent that such exemption is necessary or appropriate in the public interest, and is consistent with the protection of investors.”
The lack of communications, transportation, electricity, facilities, and available staff and professional advisors as a result of Hurricane Michael could hamper the efforts of companies with reporting obligations to meet their filing deadlines pursuant to Regulation Crowdfunding or Regulation A. At the same time, investors have an interest in the timely availability of required information about these companies. While the Commission believes that the temporary relief from filing requirements provided by the amendments to Rule 202 of Regulation Crowdfunding
Accordingly, pursuant to Section 28 of the Securities Act, we are adopting interim final temporary rules providing that an issuer subject to the reporting
(a) The issuer is not able to meet a filing deadline due to Hurricane Michael or its aftermath;
(b) The issuer files with the Commission, on or before November 23, 2018, the report or form required to be filed pursuant to either Regulation Crowdfunding or Regulation A during the period from and including October 10, 2018 to and including November 21, 2018; and
(c) In any such report or form, the issuer discloses that it is relying on the interim final temporary rules and states the reasons why, in good faith, it could not file such report or form on a timely basis.
For Regulation Crowdfunding, the relief includes annual reports on Form C-AR, progress updates on Form C-U, and termination of reporting on Form C-TR. For Regulation A, the relief includes post-qualification amendments required at least every 12 months after the qualification date to include updated financial statements, annual reports on Form 1-K, semi-annual reports on Form 1-SA, special financial reports on Forms 1-K or 1-SA, current reports on Form 1-U, and exit reports on Form 1-Z.
Regulation Crowdfunding and Regulation A permit offers and sales of securities without registration under the Securities Act, subject to certain limitations and conditions, including compliance with ongoing reporting requirements. Based on staff analysis, between June 19, 2015 (the effective date of the most recent Regulation A amendments
We lack the data to estimate the number of investors in Regulation A or Regulation Crowdfunding offerings that could be affected if issuers rely on the relief provided by the interim final temporary rules, because information on the number of investors is generally not required to be disclosed in periodic or current reports required under Regulation A or in periodic reports or progress updates required under Regulation Crowdfunding.
We are mindful of the costs and benefits of the interim final temporary rules.
The requirement for an issuer to disclose that it is relying on Rule 202(c) of Regulation Crowdfunding or Rule 257(f) of Regulation A and to state the reasons why, in good faith, it could not file a report or form on a timely basis may impose minimal additional costs on issuers availing themselves of this relief. However, we believe that these minimal costs are justified in light of the significant negative implications of not being able to rely on the exemption and the prohibitively high costs an issuer may incur in attempting to file in a timely manner.
We also acknowledge that there may be costs imposed on investors, intermediaries, and other market participants due to delayed access to information about offerings conducted in reliance on Regulation A and Regulation Crowdfunding. Generally, reporting requirements strengthen investor protection and decrease the extent of information asymmetries between issuers and investors. Ongoing reporting provides investors with periodically updated information, allowing them to assess investment opportunities based on the information provided and their level of risk tolerance, resulting in better informed investment decisions and improved allocative efficiency. Given that the interim final temporary rules allow for delayed reporting for a limited time period and only under specified conditions, we do not believe such costs will be significant.
The interim final temporary rules will not substantially affect competition or capital formation. We acknowledge the possibility that the interim final temporary rules may have a minor impact on efficiency. On the one hand, as noted above, the delay in reporting could marginally affect allocative efficiency to the extent that it allows information asymmetries between investors and issuers to persist for the length of time of the delay. On the other hand, we expect efficiency gains to the extent that the interim final temporary rules allow issuers to continue to rely on either of the exemptions from registration that would not be available if one of the required reports that is a condition to the exemptions was not filed in a timely manner, or to the extent the issuers are able to avoid paying a premium to service providers in an attempt to file in a timely manner by delaying reporting during the specified relief period.
As an alternative to the relief specified in the interim final temporary rules, we could have considered a longer or shorter relief period. While a shorter period would have reduced the costs to investors of asymmetric information, it would also reduce the benefits of the interim final temporary rules to issuers. Similarly, a longer period would increase the costs to investors. We believe that the approximately six-week delay in the interim final temporary rules is appropriate given the potential impact Hurricane Michael or its aftermath could have on the efforts of companies to meet filing deadlines pursuant to Regulation Crowdfunding and Regulation A.
The Administrative Procedure Act (“APA”) generally requires an agency to
Given the temporary nature of the relief contemplated by the interim final temporary rules and the significant and immediate impact of Hurricane Michael and its aftermath on issuers in affected areas, as discussed above, the Commission finds that good cause exists to dispense with notice and comment as impracticable and unnecessary, and to act immediately to amend Rule 202 of Regulation Crowdfunding and Rule 257 of Regulation A.
We are adopting amendments to Rule 202 of Regulation Crowdfunding and Rule 257 of Regulation A under the authority set forth in the Securities Act (15 U.S.C. 77a
Crowdfunding, Funding portals, Intermediaries, Reporting and recordkeeping requirements, Securities.
Reporting and recordkeeping requirements, Securities.
In accordance with the foregoing, title 17, chapter II of the Code of Federal Regulations is amended as follows:
15 U.S.C. 77d, 77d-1, 77s, 77z-3, 78c, 78o, 78q, 78w, 78mm, and Pub. L. 112-106, secs. 301-305, 126 Stat. 306 (2012).
(d)
(2) In any report or form filed pursuant to paragraph (d)(1) of this section, the issuer must disclose that it is relying on this paragraph (d) and state the reasons why, in good faith, it could not file such report or form on a timely basis.
15 U.S.C. 77b, 77b note, 77c, 77d, 77f, 77g, 77h, 77j, 77r, 77s, 77z-3, 77sss, 78c, 78d, 78j, 78l, 78m, 78n, 78o, 78o-7 note, 78t, 78w, 78ll(d), 78mm, 80a-8, 80a-24, 80a-28, 80a-29, 80a-30, and 80a-37, and Pub. L. 112-106, sec. 201(a), sec. 401, 126 Stat. 313 (2012), unless otherwise noted.
(g)
(2) In any report or form filed pursuant to paragraph (g)(1) of this section, the issuer must disclose that it is relying on this paragraph (g) and state the reasons why, in good faith, it could not file such report or form on a timely basis.
By the Commission.
Food and Drug Administration, HHS.
Final order.
The Food and Drug Administration (FDA or we) is classifying the positive airway pressure delivery system 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 positive airway pressure delivery system'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.
This order is effective October 19, 2018. The classification was applicable on June 5, 2018.
Deepika Arora Lakhani, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2543, Silver Spring, MD 20993-0002, 301-796-4042,
Upon request, FDA has classified the positive airway pressure delivery system as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act to a predicate device that does not require premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act and 21 CFR part 807 (21 U.S.C. 360(k) and part 807, respectively).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (21 U.S.C. 360c(f)(2)). Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)). Although the device was automatically within class III, the De Novo classification is considered to be the initial classification of the device.
We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or PMA in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.
On December 14, 2017, FRESCA Medical submitted a request for De Novo classification of the CURVE
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on June 5, 2018, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 868.5273. We have named the generic type of device positive airway pressure delivery system, and it is identified as a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface.
FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.
At the time of classification, positive airway pressure delivery systems are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)).
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collection of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in part 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, part 868 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360
(a)
(b)
(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:
(i) Waveform testing must simulate breathing conditions and evaluate pressure and airflow response over a range and combination of high and low breath rates and tidal volumes.
(ii) Use life testing must demonstrate adequate device performance over the labeled use life of the device.
(iii) Device integrity testing must demonstrate that the device can withstand typical forces expected during use.
(iv) Carbon dioxide rebreathing testing must be performed.
(v) System flow rate, maximum expiratory pressure, inhalation pressure, and intra-mask static pressure testing must be performed.
(vi) Air bolus testing must demonstrate that the device can withstand worst-case scenario air pressures.
(vii) Maximum limited pressure testing of the flow generator in single fault condition must be performed.
(viii) Maximum output temperature testing of delivered gas, if humidified, must be performed.
(3) Performance data must validate reprocessing instructions for any reusable components of the device.
(4) Performance data must demonstrate the electrical, thermal, and mechanical safety and the electromagnetic compatibility of the device.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Labeling must include the following:
(i) Therapy pressure range;
(ii) Use life and replacement schedule for all components;
(iii) Cleaning instructions; and
(iv) Instructions for assembly and connection of device components.
Food and Drug Administration, HHS.
Final order.
The Food and Drug Administration (FDA or we) is classifying the wound autofluorescence imaging device into class I. We are taking this action because we have determined that classifying the device into class I 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.
This order is effective October 19, 2018. The classification was applicable on July 31, 2018.
Yasaman Ardeshirpour, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G455, Silver Spring, MD, 20993-0002, 240-402-3706,
Upon request, FDA has classified the wound autofluorescence imaging device as class I (general controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act to a predicate device that does not require premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (21 U.S.C. 360c(f)(2)). Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)). Although the device was automatically within class III, the De Novo classification is considered to be the initial classification of the device.
We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or PMA in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.
On February 16, 2018, MolecuLight, Inc. submitted a request for De Novo classification of the MolecuLight i:X. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class I if general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(A)). After review of the information submitted in the request, we determined that the device can be classified into class I. FDA has determined that general controls will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on July 31, 2018, FDA issued an order to the requester classifying the device into class I. FDA is codifying the classification of the device by adding 21 CFR 878.4165. We have named the generic type of device wound autofluorescence imaging device, and it is identified as a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.
FDA has identified the following risks to health associated specifically with this type of device: electrical/mechanical/thermal, electromagnetic compatibility (EMC) and optical safety of the device, and the error in fluorescence detection from the wound.
Section 510(
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order refers to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 820, regarding current good manufacturing practices, have been approved under OMB control number 0910-0073; and the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, part 878 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360
(a)
(b)
Food and Drug Administration, HHS.
Final order.
The Food and Drug Administration (FDA or we) is classifying the light based energy source device for topical application 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 light based energy source device for topical application'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.
This order is effective October 19, 2018. The classification was applicable on October 18, 2012.
Neil Ogden, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G414, Silver Spring, MD, 20993-0002, 301-796-6397,
Upon request, FDA has classified the light based energy source device for topical application as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.
We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application (PMA) to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.
For this device, FDA issued an order on June 10, 2009, finding the ViruLite Cold Sore Machine not substantially equivalent to a predicate not subject to PMA. Thus, the device remained in class III in accordance with section 513(f)(1) of the FD&C Act when we issued the order.
On June 30, 2009, Pacer Therapeutics, Ltd. submitted a request for De Novo classification of the ViruLite Cold Sore Machine. FDA reviewed the request in
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on October 18, 2012, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 878.4860. We have named the generic type of device light based energy source device for topical application, and it is identified as a device that emits light energy at near infrared spectrum and is applied externally to the surface of herpes simplex labialis lesions on or around the lips.
FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.
We have determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 878 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) The technical parameters of the device, including wavelength, treatment time, treatment area, energy density, spot size, and power, must be characterized.
(2) The cleaning and disinfection instructions for the device must be validated.
(3) The device must be demonstrated to be biocompatible.
(4) Performance testing must validate electromagnetic compatibility (EMC), ocular safety, and electrical safety of the device.
(5) Labeling must direct end-users to contact the device manufacturer and MedWatch if they experience any adverse events when using this device.
(6) Labeling must include specific information pertinent to use of the device by the intended patient population and the treatment regimen.
(7) Simulated use testing must include information from a usability, label comprehension and self-selection study to demonstrate that the device can be used by the intended patient population without any assistance.
(8) Clinical data must show adequate reduction in time to healing and assess risks of redness, discomfort, burns, and blisters.
Food and Drug Administration, HHS.
Final order.
The Food and Drug Administration (FDA or we) is classifying the hemostatic device for intraluminal gastrointestinal use 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 hemostatic device for intraluminal gastrointestinal use'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.
This order is effective October 19, 2018. The classification was applicable on May 7, 2018.
Maegen Colehour, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G423, Silver Spring, MD, 20993-0002, 301-796-6436,
Upon request, FDA has classified the hemostatic device for intraluminal gastrointestinal use as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.
We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.
On March 9, 2017, Wilson-Cook Medical, Inc. submitted a request for De Novo classification of the Hemospray® Endoscopic Hemostat. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on May 7, 2018, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 878.4456. We have named the generic type of device hemostatic device for intraluminal gastrointestinal use, and it is identified as a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other means.
FDA has identified the following risks to health associated specifically with this type of device and the measures
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. We encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency to an animal test method. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.
At the time of classification, hemostatic devices for intraluminal gastrointestinal use are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)).
We have determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 820, regarding quality system regulations, have been approved under OMB control number 0910-0073; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 878 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) The device must be demonstrated to be biocompatible.
(2) Performance data must support the sterility and pyrogenicity of the device.
(3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(4) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The testing must evaluate the following:
(i) The ability to deliver the hemostatic material to the bleeding site;
(ii) The ability to achieve hemostasis in a clinically relevant model of gastrointestinal bleeding; and
(iii) Safety endpoints, including thromboembolic events, local and systemic toxicity, tissue trauma, gastrointestinal tract obstruction, and bowel distension and perforation.
(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:
(i) Materials characterization of all components must demonstrate the device meets established specifications, which must include compositional identity and purity, characterization of
(ii) Performance testing must demonstrate the mechanical integrity and functionality of the system used to deliver the device and demonstrate the device meets established specifications, including output pressure for propellant-based systems.
(6) Labeling must include:
(i) Information identifying and explaining how to use the device and its components; and
(ii) A shelf life.
Food and Drug Administration, HHS.
Final order.
The Food and Drug Administration (FDA or we) is classifying the thermal vestibular stimulator for headache 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 thermal vestibular stimulator for headache'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.
This order is effective October 19, 2018. The classification was applicable on March 26, 2018.
Stacie Gutowski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993-0002, 240-402-6032,
Upon request, FDA has classified the thermal vestibular stimulator for headache as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.
We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket application to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.
On April 18, 2017, Scion NeuroStim, LLC submitted a request for De Novo classification of the ThermoNeuroModulation Device. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on March 26, 2018, FDA issued an order to the requester classifying the device into class II. FDA
FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.
At the time of classification, thermal vestibular stimulators for headache are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)).
We have determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 820, regarding quality system regulations, have been approved under OMB control number 0910-0073; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, part 882 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360
(a)
(b)
(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Performance testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety.
(3) The technical parameters of the device, including waveform outputs and temperature limits, must be identified.
(4) Cleaning validation of earpieces must be conducted.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Labeling must include the following:
(i) Information on how the device operates and the typical sensations experienced during treatment;
(ii) A detailed summary of the device's technical parameters; and
(iii) Instructions for maintenance and cleaning of the device.
Food and Drug Administration, HHS.
Final order.
The Food and Drug Administration (FDA or we) is
This order is effective October 19, 2018. The classification was applicable on May 17, 2018.
Elvin Ng, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2431, Silver Spring, MD, 20993-0002, 240-402-4662,
Upon request, FDA has classified the intranasal electrostimulation device for dry eye symptoms as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.
We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.
On October 23, 2017, Allergan submitted a request for De Novo classification of the TrueTear Intranasal Tear Neurostimulator. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on May 17, 2018, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 886.5310. We have named the generic type of device intranasal electrostimulation device for dry eye symptoms, and it is identified as a prescription non-implantable, electrostimulation device intended to increase tear production for improvement in dry eye symptoms.
FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k).
At the time of classification, intranasal electrostimulation devices for dry eye symptoms are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)).
We have determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.
Medical devices, Ophthalmic goods and services.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 886 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360
(a)
(b)
(1) Clinical performance testing must evaluate improvement of dry eye symptoms under anticipated conditions of use.
(2) Non-clinical performance testing must assess the following electrical output specifications: waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.
(3) Patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance testing must demonstrate the electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Training for the proper use of the device must be provided.
(7) Physician and patient labeling must include:
(i) Summaries of electrical stimulation parameters;
(ii) Instructions on how to correctly use and maintain the device;
(iii) Instructions and explanations of all user-interface components;
(iv) Information related to electromagnetic compatibility classification;
(v) Instructions on how to clean the device; and
(vi) Summaries of clinical performance testing demonstrating safety and effectiveness.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Tower Drawbridge over the Sacramento River, mile 59.0, at Sacramento, CA. The deviation is necessary to allow the bridge owner to conduct mechanical and electrical rehabilitation work on the bridge. This deviation allows the bridge to remain in the closed-to-navigation position during the deviation period.
This deviation is effective without actual notice from October 19, 2018 through 6 a.m. on December 1, 2018. For the purposes of enforcement, actual notice will be used from 6 a.m. on October 8, 2018 until October 19, 2018.
The docket for this deviation, USCG-2018-0153, is available at
If you have questions on this temporary deviation, call or email Carl T. Hausner, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510-437-3516, email
The California Department of Transportation has requested a temporary change to the operation of the Tower Drawbridge, mile 59.0, over the Sacramento River, at Sacramento, CA. The drawbridge navigation span provides a vertical clearance of 30 feet above Mean High Water in the closed-to-navigation position. The draw operates as required by 33 CFR 117.189(a). Navigation on the waterway is commercial and recreational.
The drawspan will be secured in the closed-to-navigation position from 6 a.m. on October 8, 2018 through 6 a.m. on December 1, 2018, to allow the bridge owner to replace the bridge's wire rope and traveler cable and to conduct chain and trunnion bearing inspection and servicing. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.
Vessels able to pass through the bridge in the closed position may do so at any time. The bridge will be able to open for emergencies if at least 72-hour notice is given to the bridge operator. There is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation; modification.
The Coast Guard has modified a temporary deviation from the operating schedule that governs the Burnside Bridge across the Willamette River, mile 12.4, at Portland, OR. The deviation is necessary to accommodate bridge repairs and upgrades. This modified deviation extends the period the Burnside Bridge is authorized to operate in single leaf mode.
This deviation is effective without actual notice from October 19, 2018 to 4 p.m. on November 30, 2018. For purposes of enforcement, actual notice will be used from 4 p.m. on October 13, 2018, to October 19, 2018.
The docket for this deviation, USCG-2018-0300 is available at
If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email
On June 7, 2018, we published a temporary deviation entitled Drawbridge Operation Regulation; Willamette River at Portland, OR, in the
The Burnside Bridge provides a vertical clearance of 41 feet in the closed-to-navigation position referenced to Columbia River Datum 0.0, and the east leaf will be reduced to 31 feet with scaffolding installed. The horizontal clearance for the west leaf opening will be 100 feet. The normal operating schedule is in 33 CFR 117.897. Waterway usage on this part of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft. The Coast Guard contacted all known users of the Willamette River for comment, and we received no objections for this deviation.
Vessels able to pass through the bridge in the closed-to-navigation position may do so at any time. The bridge will be able to open the west side of the span only for emergencies, and there is no immediate alternate route for vessels to pass. The Coast Guard will inform the users of the waterway, through our Local and Broadcast Notices to Mariners, of the change in operating schedule for the bridges so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedules immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone on a portion of the Delaware River in Philadelphia, PA. This action is necessary to protect the surrounding public and vessels on these navigable waters adjacent to Penn's Landing, Philadelphia, PA, during a fireworks display on October 19, 2018. This regulation prohibits persons and vessels from entering, transiting, or remaining within the safety zone unless authorized by the Captain of the Port Delaware Bay or a designated representative.
This rule is effective from 11 p.m. through 11:59 p.m. on October 19, 2018.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions about this rule, call or email Petty Officer Thomas Welker, U.S. Coast Guard, Sector Delaware Bay, Waterways Management Division; telephone 215-271-4814, email
On June 18, 2018, a wedding party notified the Coast Guard that it will be conducting a fireworks display from 11:15 p.m. to 11:45 p.m. on October 19, 2018. The fireworks are to be launched from a barge in the Delaware River adjacent to Penn's Landing in Philadelphia, PA. In response, on September 28, 2018, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zone; Delaware River; Penn's Landing; Philadelphia, PA; Fireworks Display; 83 FR 49026. There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this fireworks display. During the comment period that ended October 5, 2018, we received one comment.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Delaware Bay (COTP) has determined that potential hazards associated with the fireworks display on October 19, 2018, will be a safety concern for anyone within 500 feet of a fireworks barge in the Delaware River adjacent to Penn's Landing in Philadelphia, PA. The barge will be anchored in approximate position 39°57′05.26″ N Latitude 075°08′10.85″ W Longitude. This rule is needed to protect persons, vessels and the public near the fireworks barge during the fireworks display.
As noted above, we received one comment on our NPRM published September 28, 2018. The comment we received was unrelated to the proposed regulation. There is one change in the regulatory text of this rule from the proposed rule in the NPRM. The enforcement period was changed from 11:15 p.m. through 11:45 p.m. to 11 p.m. through 11:59 p.m. on the same date. We made this change to account for movement of the barge into and out of the anchor location.
This rule establishes a safety zone from 11 p.m. through 11:59 p.m. on October 19, 2018, for the navigable waters in the vicinity of Penn's Landing, Philadelphia, PA, during a fireworks display from a barge. The event is scheduled to take place at approximately 11:15 p.m. on October 19, 2018. The safety zone will extend 500 feet around the barge, which will be anchored at approximate position 39°57′05.26″ N Latitude 075°08′10.85″ W Longitude. Persons or vessels will not be permitted to enter, transit through, or remain within the safety zone without obtaining permission from the COTP or a designated representative.
If authorization to enter, transit through, or remain within the safety zone is granted by the COTP or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the COTP or a designated representative. The Coast Guard will provide public notice of the safety zone by Broadcast Notice to Mariners and by on-scene actual notice.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic would be able to safely transit around this safety zone which will impact a small designated area of the Delaware River for one hour during the evening when vessel traffic is normally low. Moreover, the Coast Guard would issue a Broadcast Notice to
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting one hour that would prohibit entry within 500 feet of a fireworks barge. Normally such actions are categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(i) You may not enter the safety zone described in paragraph (a) of this section unless authorized by the COTP or the COTP's designated representative; and
(ii) All persons and vessels in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.
(2) To request permission to enter the safety zone, contact the COTP or the COTP's representative on marine band radio VHF-FM channel 16 (156.8 MHz) or 215-271-4807.
(3) No vessel may take on bunkers or conduct lightering operations within the safety zone during the enforcement period.
(4) This section applies to all vessels except those engaged in law enforcement, aids to navigation servicing, and emergency response operations.
(d)
(e)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone in the navigable waters of San Francisco Bay in support of the Hornblower Fireworks Display on October 20, 2018. This safety zone is necessary to protect personnel, vessels, and the marine environment from the dangers associated with pyrotechnics. Unauthorized persons or vessels are prohibited from entering into, transiting through, or remaining in the safety zone without permission of the Captain of the Port or their designated representative.
This rule is effective from 11 a.m. to 10:10 p.m. on October 20, 2018.
Documents mentioned in this preamble are part of docket USCG-2018-0847. To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Chief Warrant Officer Mickey Price, U.S. Coast Guard Sector San Francisco; telephone (415) 399-7442 or email at
The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule. Since the Coast Guard received notice of this event on September 8, 2018, notice and comment procedures would be impracticable in this instance.
For similar reasons as those stated above, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port (COTP) San Francisco has determined that potential hazards associated with the Hornblower Fireworks Display on October 20, 2018, will be a safety concern for anyone within a 100 foot radius of the fireworks barge and anyone within a 420 foot radius of the fireworks firing site. This rule is needed to protect spectators, vessels, and other property from hazards associated with pyrotechnics.
This rule establishes a temporary safety zone during the loading, staging, and transit of the fireworks barge, until after completion of the fireworks display. During the loading and staging of the pyrotechnics onto the fireworks barge, scheduled to take place from 11 a.m. to 8:30 p.m. on October 20, 2018, at Pier 50 in San Francisco, CA, the safety zone will encompass the navigable waters around and under the fireworks barge within a radius of 100 feet.
The fireworks barge will remain at Pier 50 until the start of its transit to the display location. Towing of the barge from Pier 50 to the display location is scheduled to take place from 8:30 p.m. to 9 p.m. on October 20, 2018, where it will remain until the conclusion of the fireworks display.
At 9 p.m. on October 20, 2018, 30 minutes prior to the commencement of the 10 minute fireworks display, the safety zone will increase in size and encompass the navigable waters around and under the fireworks barge within a radius of 420 feet in approximate position 37°48′15″ N, 122°23′27″ W (NAD 83) for the Hornblower Fireworks Display. The safety zone shall terminate at 10:10 p.m. on October 20, 2018.
The effect of the temporary safety zone is to restrict navigation in the vicinity of the fireworks loading, staging, transit, and firing site. Except for persons or vessels authorized by the COTP or the COTP's designated representative, no person or vessel may enter or remain in the restricted areas. These regulations are needed to keep spectators and vessels away from the immediate vicinity of the fireworks firing sites to ensure the safety of participants, spectators, and transiting vessels.
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant
This regulatory action determination is based on the limited duration and narrowly tailored geographic area of the safety zone. Although this rule restricts access to the waters encompassed by the safety zone, the effect of this rule will not be significant because the local waterway users will be notified via public Notice to Mariners to ensure the safety zone will result in minimum impact. The entities most likely to be affected are waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
This rule may affect the following entities, some of which may be small entities: owners and operators of waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities and sightseeing, if these facilities or vessels are in the vicinity of the safety zone at times when this zone is being enforced. This rule will not have a significant economic impact on a substantial number of small entities for the following reasons: (i) This rule will encompass only a small portion of the waterway for a limited period of time, and (ii) the maritime public will be advised in advance of these safety zones via Notice to Mariners.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone of limited size and duration. It is categorically excluded from further review under Categorical Exclusion L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(d)
(2) The safety zone is closed to all vessel traffic, except as may be permitted by the COTP or a designated representative.
(3) Vessel operators desiring to enter or operate within the safety zone must contact the COTP or a designated representative to obtain permission to do so. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the COTP or a designated representative. Persons and vessels may request permission to enter the safety zones on VHF-23A or through the 24-hour Command Center at telephone (415) 399-3547.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone on the Fox River in Green Bay, WI, for all navigable waters within a 210-foot radius of the approximate launch position at 44°31.016′ N, 088°01.016′ W (NAD 83). This action is necessary to protect spectators, mariners, vessels, and property from potential 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 Lake Michigan or a designated representative.
This rule is effective from 7 p.m. through 7:30 p.m. on October 26, 2018.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this document, call or email the marine event coordinator, MSTC Kaleena Carpino, Prevention Department, Coast Guard Sector Lake Michigan, Milwaukee, WI; telephone (414) 747-7148, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The final details for this event were not known to the Coast Guard until there was insufficient time remaining before the event to publish an NPRM. Delaying the effective date of this rule to wait for a comment period to run would be both impracticable and contrary to the public interest because it would inhibit the Coast Guard's ability to protect the public, vessels, mariners, and property from the hazards associated with the fireworks display on October 26, 2018.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The legal basis for this rule is the Coast Guard's authority to establish safety zones: 33 U.S.C. 1231; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
The Coast Guard will enforce a safety zone on October 26, 2018, from 7 p.m. through 7:30 p.m., for a fireworks display on Fox River in Green Bay, WI. The Captain of the Port Lake Michigan has determined that this fireworks display will pose a significant risk to public safety and property. Such hazards include premature and accidental detonations, falling and burning debris, and collisions among spectator vessels.
With the aforementioned hazards in mind, the Captain of the Port Lake Michigan has determined that this temporary safety zone is necessary to protect persons and vessels during the fireworks display in the waters of Fox River, in Green Bay, WI. This zone is effective and will be enforced from 7 p.m. through 7:30 p.m. on October 26, 2018. The safety zone will encompass all navigable waters of Fox River within a 210-foot radius of the approximate launch position at 44°31.016′ N, 088°01.016′ W (NAD 83).
Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Lake Michigan or a designated on-scene representative. The Captain of the Port or a designated on-scene representative may be contacted via VHF Channel 16.
We developed this rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive Orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. The safety zone created by this rule will be relatively small and enforced for only 30 minutes. Under certain conditions, vessels may still transit through the safety zone when permitted by the Captain of the Port. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
This rule will affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in the affected portion of Fox River, in Green Bay, WI between 7 p.m. through 7:30 p.m. on October 26, 2018. This safety zone will not have a significant economic impact on a substantial number of small entities for the reasons cited in the
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of a safety zone surrounding a fireworks display on Fox River, in Green Bay, WI. It is categorically excluded from further review under paragraph L[60(a)] of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) This safety zone is closed to all vessel traffic, except as may be permitted by the Captain of the Port Lake Michigan or a designated on-scene representative.
(3) The “on-scene representative” of the Captain of the Port Lake Michigan is any Coast Guard commissioned, warrant or petty officer who has been designated by the Captain of the Port Lake Michigan to act on his or her behalf.
(4) Vessel operators desiring to enter or operate within the safety zone must contact the Captain of the Port Lake Michigan or an on-scene representative to obtain permission to do so. The Captain of the Port Lake Michigan or an on-scene representative may be contacted via VHF Channel 16. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the Captain of the Port Lake Michigan or an on-scene representative.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is finalizing a determination of attainment by the attainment date and a clean data determination (CDD) for the 2006 24-hour fine particulate matter (PM
This final rule is effective on October 19, 2018.
The EPA has established dockets for this action under Docket ID No. EPA-R08-OAR-2018-0309 and/or Docket ID No. EPA-R10-OAR-2018-0316. All documents in the docket are listed on the
Crystal Ostigaard, Air Program, EPA, Region 8, Mail Code 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129, (303) 312-6602,
Throughout this document, wherever “we”, “us” or “our” is used, it is intended to refer to the EPA.
On October 17, 2006 (71 FR 61144), the EPA revised the level of the 24-hour PM
On July 17, 2018 (83 FR 33886), the EPA proposed to determine, based on the most recent 3 years (2015-2017) of valid data,
The EPA received eight public comments on the proposed action. Three of the comments related to forestry practices and wildfire management, primarily in California. One comment related to child labor practices in South America. One comment related to homelessness in California. Another comment discussed
The ICL comment raises concerns regarding monitoring data trends at the Franklin, ID and, to a lesser extent, the Smithfield, UT sites. The comment states that the 3-year average (2015-2017) at the Franklin, ID monitoring site was 30 µg/m
In accordance with section 188(b)(2) of the CAA, the EPA is required to determine within 6 months of the applicable attainment date whether a nonattainment area attained the standard by that date. On September 8, 2017, the EPA extended the attainment date for the Logan, UT-ID PM
The EPA has established regulations for determining if the 24-hour PM
Also, the 3-year design values are lower for the time period used for this attainment determination compared to the time period when the area was designated nonattainment. The Logan, UT design value used for designations
Pursuant to CAA section 188(b)(2), the EPA is finalizing a determination, based on the most recent 3 years (2015-2017) of valid data, that the Logan, UT-ID nonattainment area has attained the 2006 primary and secondary 24-hour PM
In addition, the EPA is finalizing a determination that the obligation to submit any remaining attainment-related SIP revisions arising from classification of the Logan, UT-ID area as a Moderate nonattainment area under subpart 4 of part D (of title I of the Act) for the 2006 24-hour PM
As discussed in the 2015 PM
This determination does not invalidate any prior actions that the EPA has made on any Moderate PM
This final action does not constitute a redesignation of the Logan, UT-ID nonattainment area to attainment for the 2006 24-hour PM
In accordance with 5 U.S.C. 553(d), the EPA finds there is good cause for these determinations to become effective immediately upon publication in the
This action finalizes a determination of attainment based on air quality and suspends certain federal requirements, and thus would not impose additional requirements beyond those imposed by state law. For this reason, this final action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not expected to be an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because this action is not significant under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 18, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of prothioconazole in or on rapeseed subgroup 20A. Bayer CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective October 19, 2018. Objections and requests for hearings must be received on or before December 18, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0531, is available at
Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Publishing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0531 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 18, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0531, by one of the following methods:
•
•
•
In the
Based upon review of the data supporting the petition, EPA is establishing the tolerance requested by the petitioner as Rapeseed subgroup 20A, to be consistent with the commodity terminology commonly used by the Agency.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of, and to make a determination on aggregate exposure for prothioconazole including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with prothioconazole follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
Prothioconazole degrades into different compounds in different matrices, with prothioconazole-desthio (desthio) being the metabolite and degradate of concern. The target organs of prothioconazole and the desthio metabolite include the liver, kidney, bladder, thyroid and blood. In addition, the chronic studies showed body weight and food consumption changes, and toxicity to the lymphatic and gastrointestinal systems.
Developmental studies show that prothioconazole and its metabolites produce adverse effects including malformations in the conceptus at levels equal to or below maternally toxic levels, particularly those studies conducted using prothioconazole-desthio. Reproduction studies in the rat with prothioconazole and prothioconazole-desthio suggest that these chemicals do not adversely affect reproductive parameters or the offspring except at parentally toxic dose levels. Acute and subchronic neurotoxicity studies, as well as a developmental neurotoxicity study, raise no neurotoxicity concerns. Immunotoxicity data show that prothioconazole is not an immunotoxicant.
The available carcinogenicity and/or chronic studies in the mouse and rat, using both prothioconazole and prothioconazole-desthio, show no increase in tumor incidence and EPA has concluded that prothioconazole and its metabolites are not carcinogenic.
Specific information on the studies received and the nature of the adverse effects caused by prothioconazole as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
A summary of the toxicological endpoints for prothioconazole used for human risk assessment is discussed in Unit III.B of the final rule published in the
1.
i.
Such effects were identified for prothioconazole for females 13-50 years old. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA; 2003-2008). As to residue levels in food, EPA assumed tolerance-level values for the proposed new uses and existing tolerances on berries, cucurbit vegetables, cottonseed, sugar beet roots, and sunflower subgroup 20B, average field trial residues for all other commodities, and DEEM default and empirical processing factors. 100 percent crop treated (PCT) was assumed for all proposed and established commodities.
ii.
iii.
iv.
The Agency did not use percent crop treated estimates for the dietary assessment.
2.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM/GW), the estimated drinking water concentrations (EDWCs) of prothioconazole for acute exposures are estimated to be 109 parts per billion (ppb) for surface water and 132 ppb for ground water and for chronic exposures are estimated to be 97 ppb for surface water and 128 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 132 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 128 ppb was used to assess the contribution to drinking water.
3.
4.
Prothioconazole is a member of the conazole class of pesticides containing the 1,2,4-triazole moiety. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events in mammals (EPA, 2002). In the case of conazoles, however, a variable pattern of toxicological responses is found. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no conclusive data to indicate that conazoles share common mechanisms of toxicity, and EPA is not following a cumulative risk approach for this the conazoles. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's website at
Prothioconazole is a triazole-derived pesticide. This class of compounds can form the common metabolite 1,2,4-triazole and two triazole conjugates (triazolylalanine and triazolylacetic acid). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, including prothioconazole, EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, triazolylalanine, and triazolylacetic acid resulting from the use of all current and pending uses of any triazole-derived fungicide. The risk assessment is a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (
An updated dietary exposure and risk analysis for the common triazole metabolites 1,2,4-triazole (T), triazolylalanine (TA), triazolylacetic acid (TAA), and triazolylpyruvic acid (TP) was completed on July 18, 2017, in association with registration requests for the triazole fungicides difenoconazole and tetraconazole. That analysis concluded that risk estimates were below the Agency's level of concern for all population groups. The proposed new uses of prothioconazole are not expected to significantly increase the dietary exposure estimates for free triazole or conjugated triazoles; thus, the Agency is relying on the July 18, 2017 analysis to support its conclusion that the exposure to the triazole metabolite, including exposures from the use of prothioconazole on the commodities in subgroup 20A, does not present risks of concern. This assessment may be found on
1.
2.
3.
i. The toxicity database for prothioconazole is complete.
ii. No neurotoxicity was seen in acute and subchronic neurotoxicity studies and other studies with prothioconazole or prothioconazole-desthio. Although offspring neurotoxicity was found, characterized by peripheral nerve lesions in the developmental neurotoxicity study on prothioconazole-desthio, the increase was seen only in the highest dose group at 105 mg/kg/day. Further, a NOAEL was established for the peripheral nerve lesions and all of the PODs used in the risk assessment were protective of this finding.
iii. Evidence of quantitative and qualitative susceptibility of offspring were observed in the developmental studies. However, basing the POD on the offspring in the most sensitive of these studies provides the needed protection of offspring.
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues for the proposed new uses and existing tolerances on berries, cucurbit vegetables, cottonseed, sugar beet roots, and sunflower subgroup 20B, average field trial residue levels for the remaining uses, and DEEM default and empirical processing factors. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to prothioconazole in drinking water. These assessments will not underestimate the exposure and risks posed by prothioconazole.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
1.
2.
3.
Both short- and intermediate-term adverse effects were identified; however, prothioconazole is not registered for any use patterns that would result in either short- or intermediate-term residential exposure. Short- and intermediate-term risk is assessed based on short- and intermediate-term residential exposure plus chronic dietary exposure. Because there is no short- or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short- or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for prothioconazole.
4.
5.
Adequate liquid chromatography with tandem mass spectrometry (LC/MS/MS) methods are available for enforcing prothioconazole tolerances in crop and livestock commodities.
The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has established MRL for prothioconazole in or on rapeseed at 0.1 ppm. The MRL is different than the
Two comments were submitted in response to the Notice of Filing for tolerance expansion. One comment (Comment A) requested that EPA deny this tolerance petition based on the radioactivity of prothioconazole and its role as a developmental toxicant. The other comment (Comment B) requested that EPA deny this petition based on the persistence of prothioconazole in the digestive system and effects on the liver, kidney, and thyroid.
Therefore, tolerances are established for residues of prothioconazole, 2-[2-(1-chlorocylcopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thione, and its desthio metabolite, in or on rapeseed subgroup 20A at 0.15 ppm. In addition, EPA is removing the existing tolerance for “rapeseed, seed” as it is superseded by the new tolerance for subgroup 20A.
This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
The addition reads as follows:
(a) * * *
(1) * * *
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of boscalid in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective October 19, 2018. Objections and requests for hearings must be received on or before December 18, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0310, is available at
Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0310 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 18, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0310, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Based upon review of the data supporting the petition, EPA has modified the levels at which some of the tolerances are being established. The reasons for these changes are explained in Unit IV.C.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for boscalid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with boscalid follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
In mammals, the target organs are the liver and the thyroid (indirectly from liver adaptive response). In subchronic and chronic feeding studies in rats, mice and dogs, boscalid generally caused decreased body weights (primarily in mice) and effects on the liver (increase in weights, changes in enzyme levels and histopathological changes) as well as on the thyroid (increase in weights and histopathological changes). Mode of action studies conducted in rats indicated that boscalid has a direct effect upon the liver and that the thyroid effects are secondary. A reversibility study in rats indicated that both liver and thyroid parameters returned to control values after the animals were placed on control diet. Absolute and/or relative thyroid weights were elevated in rats and dogs, but there were no histopathological changes observed in the thyroid in either mice or dogs.
In a developmental toxicity study in rats, no developmental toxicity was observed in the fetuses at the highest dose tested (limit dose). No effects were noted in the dams in this study. In a developmental toxicity study in rabbits, an increased incidence of abortions or early delivery was observed at the limit dose. There was quantitative evidence of increased susceptibility in the two-generation reproduction study in rats, where decreases in body weights in male offspring were seen at a dose that was lower than the dose that induced parental/systemic toxicity. There was quantitative evidence of increased susceptibility in the developmental neurotoxicity study in rats, where decreases in pup body weights on post-natal day four (PND 4) and body weight gains (PND 1-4) were seen in the absence of any maternal toxicity.
In a 2-year chronic toxicity study and a 2-year carcinogenicity study in male and female rats, the combined data showed an increased trend in thyroid follicular cell adenomas that appeared to be treatment-related in males. This was supported by thyroid hypertrophy and hyperplasia of follicular cells at the same dose as well as increased thyroid weights plus mechanistic data. Despite these findings, the Agency has determined that quantification of the cancer risk is not necessary because (1) the adenomas occurred at dose levels above the level used to establish the chronic population adjusted dose (cPAD); (2) statistically significant increases were only seen for benign tumors (adenomas) and not for malignant ones (carcinomas); (3) the increase in adenomas in females was slight; and (4) there was no evidence of mutagenicity. Furthermore, the mouse carcinogenicity study was negative.
There was no evidence of neurotoxicity in rats in the acute, subchronic or developmental studies up to the limit dose. No neurotoxic observations were noted in any of the other studies in any species. Similarly, there was no evidence of immunotoxicity in the available immunotoxicity study in rats, or in any of the other studies in the database.
Specific information on the studies received and the nature of the adverse effects caused by boscalid as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment.
A summary of the toxicological endpoints for boscalid used for human risk assessment is discussed in Unit III.B. of the final rule published in the
1.
i.
ii.
iii.
iv.
2.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) model and Pesticide Root Zone Model Ground Water (PRZM GW) model, the estimated drinking water concentrations (EDWCs) of boscalid for chronic exposures are estimated to be 26.4 ppb for surface water and 697 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the chronic dietary risk assessment, the water concentration of value 697 ppb was used to assess the contribution to drinking water.
3.
Boscalid is currently registered for the following uses that could result in residential exposures: Golf course turf, residential fruit and nut trees, and residential ornamentals and landscape gardens. EPA assessed residential exposure using the following assumptions:
All residential exposures are considered short-term in duration. The residential handler assessment included short-term exposures via the dermal and inhalation routes from treating residential ornamentals, landscape gardens, and trees.
In terms of post-application exposure, there is the potential for dermal post-application exposure for individuals as a result of being in an environment that has been previously treated with boscalid. Short-term dermal exposures were assessed for adults, youth 11 to 16 years old, and children 6 to 11 years old. Incidental oral exposure to children 1 to 2 years old is not expected from treated turf because boscalid is registered for use only on golf course turf and residential gardens and trees, and the extent to which young children utilize these areas is low.
The scenarios used in the aggregate assessment were those that resulted in the highest exposures. The highest exposures for all age groups were associated with only residential post-application dermal exposures, not inhalation exposures, and consist of the following:
• The residential dermal exposure for use in the adult aggregate assessment reflects dermal exposure from post-application activities on treated gardens.
• The residential dermal exposure for use in the youth (11-16 years old) aggregate assessment reflects dermal exposure from post-application golfing on treated turf.
• The residential dermal exposure for use in the child (6-11 years old) aggregate assessment reflects dermal exposure from post-application activities in treated gardens.
Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
4.
EPA has not found boscalid to share a common mechanism of toxicity with any other substances, and boscalid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that boscalid does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at
1.
2.
There was evidence of increased qualitative susceptibility in the rabbit developmental study as characterized by an increased incidence of abortions or early delivery at the limit dose. It could not be ascertained if the abortions were the result of a treatment-related effect on the dams, the fetuses or both. It was concluded that the degree of concern is low because the increased abortions or early delivery was seen only at the limit dose and the abortions may have been due to maternal stress.
There was evidence of increased quantitative susceptibility seen in the rat 2-generation reproduction study and the developmental neurotoxicity study, in that reduced body weights were seen in the offspring at dose levels where no parental toxicity was observed. However, the degree of concern is low because the dose selected for chronic dietary and non-dietary exposure risk assessments is lower than the dose that caused the body weight effects, and the effect was shown to be reversible in the developmental neurotoxicity study.
3.
i. The toxicity database is complete, with the exception of a subchronic inhalation study. EPA is retaining a 10X FQPA SF for assessing residential inhalation risks to adult applicators.
ii. There is no indication that boscalid is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. For the reasons listed in Unit III.D.2., the Agency has concluded that there are no residual uncertainties concerning the potential for prenatal and post-natal toxicity.
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to boscalid in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children. These assessments will not underestimate the exposure and risks posed by boscalid.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
1.
2.
3.
Boscalid is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to boscalid.
Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 300 for adults, 660 for youths 11 to 16 years old and 300 for children 6 to 11 years old. Because EPA's level of concern for boscalid is a MOE of 100 or below, these MOEs are not of concern.
4.
An intermediate-term adverse effect was identified; however, boscalid is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for boscalid.
5.
6.
Adequate enforcement methodology (gas chromatography/mass spectrometry (GC/MS)) is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905;
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has established MRLs for boscalid in or on several of the commodities that are different than the tolerances established for boscalid in the United States, however, the tolerance expression in the U.S. differs from the Codex MRL expression. Also, the submitted residue data support higher tolerance levels than those set by Codex, indicating that harmonization would cause legal application of pyraclostrobin by U.S. users to result in exceedances of domestic tolerances. Therefore, further harmonization of U.S. tolerances with Codex MRLs is not possible at this time.
The petitioner proposed a tolerance of 50 ppm for the
Therefore, tolerances are established for residues of boscalid in or on
Additionally, the following existing tolerances and inadvertent tolerances are removed as unnecessary due to the establishment of the new tolerances.
This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
The additions read as follows:
(a) * * *
(1) * * *
Environmental Protection Agency (EPA).
Final rule.
This regulation amends the exemption from the requirement of a tolerance for residues of tetrahydrofurfuryl alcohol (THFA) (CAS Reg. No. 97-99-4) when used as an inert ingredient in pesticide formulations to add one herbicide application prior to the preboot stage on buckwheat, oats, rye, sorghum, triticale, rice and wild rice; extend use on canola to the early bolting stage; extend use on soybeans prior to the bloom growth stage; and allow use in herbicides with two applications to field corn and popcorn prior to 36 inches tall (V8 stage). Toxcel, LLC, on behalf of Penn A Kem, LLC, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an amendment to an existing exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of tetrahydrofurfuryl alcohol.
This regulation is effective October 19, 2018. Objections and requests for hearings must be received on or before December 18, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2013-0098, is available at
Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2013-0098, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Toxcel, LLC, on behalf of Penn A Kem, LLC, submitted a revised pesticide petition to supersede the previously submitted petition. EPA issued a document in the
Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. In making this safety finding, EPA is required to take into account the considerations set forth in section 408(b)(2)(C) and (D). 21 U.S.C. 346a(c)(2)(B). Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for tetrahydrofurfuryl alcohol including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with tetrahydrofurfuryl alcohol follows.
EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of
Acute toxicity information is available for the oral route with an LD
Although data on chronic effects is unavailable, subchronic studies indicate that systemic effects from repeated dermal and oral exposure to tetrahydrofurfuryl alcohol include decreased body weight and body weight gain. Tetrahydrofurfuryl alcohol also exhibits adverse reproductive and developmental effects, and potential effects on the endocrine system.
Males are not only quantitatively more sensitive to the subchronic effects of tetrahydrofurfuryl alcohol than females, but the male reproductive system appears to be a target for tetrahydrofurfuryl alcohol. Consistent decreases in male reproductive organ weights (testicular, epididymal, and seminal vesicle) were observed in rats in the 90-day dietary (LOAEL 339 mg/kg/day), dermal (LOAEL 300 mg/kg/day), and inhalation (LOAEL <0.21 mg/L/day) toxicity studies. In addition, a 90-day oral (dietary) study in dogs revealed decreased testes weights of males in all treated groups (1,000, 3,000, 6,000 ppm, equivalent to approximately 25, 75, and 150 mg/kg/day), compared to controls, with severe testicular atrophy in all males at the highest dose (6,000 ppm or 150 mg/kg/day). Decreased spermatogenic activity was noted in males of the 3,000 ppm group (75 mg/kg/day) and was interpreted as a prodromal sign of atrophy.
A 28-day repeated oral (gavage) study in rats revealed significant decreases in absolute testes and epididymal weights after 28 days at a dose level of 600 mg/kg/day which continued through the 14-day recovery period. Necrosis of the seminiferous tubular epithelium of the testes was also observed in males of the 150 and 600 mg/kg/day group at 28 days. Necrosis of the testes was also observed in males of the 600 mg/kg/day group at the end of the 14-day recovery period.
In the reproduction/developmental toxicity screening test in rats, no reproductive parameters were affected except slightly increased gestation length at the high dose of 150 mg/kg/day.
The endocrine system may also be a target for tetrahydrofurfuryl alcohol. Alterations in pituitary, thymus, adrenal, and thyroid weights have been reported after subchronic exposure (28 days) to 600 mg/kg/day in male rats and pituitary weights at 150 mg/kg/day in female rats. Decreased absolute and relative adrenal weights were observed in males and females receiving 5,000 ppm (equivalent to 339 mg/kg/day males and 401 mg/kg/day females).
In one developmental toxicity study in rats a quantitative susceptibility based on decreased fetal body weights and a qualitative susceptibility based on increased incidence of filamentous tail was observed. However, in a more recent reproduction/developmental toxicity screening test (OECD 421 guideline study) in rats, an increased incidence of filamentous tail was not evident nor was there any other evidence of increased qualitative susceptibility. Based on the overall weight of evidence for developmental toxicity, it is determined that there is increased quantitative susceptibility but not increased qualitative susceptibility.
A neurotoxicity study is not available for tetrahydrofurfuryl alcohol, however no neurotoxic effects were observed in the available subchronic oral, dermal and inhalation toxicity studies.
Mutagenicity studies indicate tetrahydrofurfuryl alcohol is not mutagenic in
There are currently no chronic toxicity or cancer studies available for tetrahydrofurfuryl alcohol. The Agency used a qualitative structure activity relationship (SAR) database, DEREK Nexus, to determine if there were structural alerts for potential carcinogenicity for tetrahydrofurfuryl alcohol. No structural alerts for carcinogenicity were identified for tetrahydrofurfuryl alcohol. In the absence of any structural alerts and lack of mutagenicity concerns, tetrahydrofurfuryl alcohol is not expected to be carcinogenic.
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
1.
2.
In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper-bound exposure estimates for the subject inert ingredient. Upper-bound exposure estimates are based on the highest tolerance for a given commodity from a list of high-use insecticides, herbicides and fungicides. A complete discussion of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyethoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessment for the Inerts” (D361707, S. Piper 2/25/09) and can be found at
In the case of tetrahydrofurfuryl alcohol residues resulting from foliar applications, EPA made specific adjustments to the dietary exposure assessments to account for the use limitations of tetrahydrofurfuryl alcohol as well as some residue chemistry data (plant uptake data) submitted with the petition. The use of the dietary estimated exposure model (DEEM) for upper-bound dietary risk assessments as described above was modified to include only those commodities on which pesticide formulations containing tetrahydrofurfuryl alcohol are being
For seed treatment use, it was conservatively assumed that all of the following commodities (which represent an agglomeration of all commodities for which seed treatment pesticide products are approved for use) could potentially be treated with a seed treatment pesticide containing tetrahydrofurfuryl alcohol: barley, corn (field, pop, sweet and corn for seed production), legume vegetables (dried shelled peas and beans), brassica and bulb vegetables, alfalfa, cucurbits, rye, wheat, cotton, sugar beets, and sunflowers. For seed treatment use, in the absence of THFA-specific data, residue chemistry data for active ingredients with seed treatment uses were utilized. Residue levels for pesticide active ingredients used for seed treatment are all below the limit of detection, so a highly conservative value of 0.05 ppm is used in the dietary exposure assessment as a residue value for THFA for all seed treatment commodities based on application of Agency policies for assigning values to nondetected/nonquantified pesticide residues.
3.
4.
Tetrahydrofurfuryl alcohol is contained in a pesticide currently registered for uses that could result in residential exposures. The use pattern of the product includes application to dogs. EPA assessed this residential exposure using the Agency's Standard Operating Procedures for Residential Pesticide Exposure Assessment Residential Exposure (Residential SOP). Based on the Treated Pets section of the Residential SOP, the following assumptions are made: for residential handlers, exposure (dermal and inhalation) is expected to be short-term only. Residential post-application dermal exposure (short-term only) was assessed for adults and children. Residential post-application inhalation exposure is generally not assessed for pet treatment product uses as such exposure is typically considered to be negligible. Incidental oral post-application exposure was assessed for children 1 to 2 years old. All post-application exposures are expected to be short-term in duration. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
5.
EPA has not found tetrahydrofurfuryl alcohol to share a common mechanism of toxicity with any other substances, and tetrahydrofurfuryl alcohol does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that tetrahydrofurfuryl alcohol does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at
1.
2.
3.
i. The toxicity database for tetrahydrofurfuryl alcohol consists of a 28-day and 90-day oral toxicity studies in rats, dogs, 90-day dermal toxicity study in rats, 90-day inhalation toxicity study in rats, several mutagenicity studies, developmental/reproductive toxicity screening study in rats, and a developmental toxicity study and reproductive toxicity study in rats.
ii. Slight atrophy of thymus was seen in high dose animal groups in the 28-day oral toxicity study, which may be indicative of an immune response, however no guideline immunotoxicity study is available.
iii. Evidence of increased quantitative susceptibility of offspring is seen in the developmental toxicity study.
iv. Additionally, alterations in the male reproductive system from subchronic exposure to tetrahydrofurfuryl alcohol does indicate
v. The FQPA factor of 10X is considered adequate to account for potential immunotoxicity and uncertainty regarding the developing reproductive system in males because clear NOAELs are established in the available database.
vi. There are no residual uncertainties identified in the exposure databases. As described earlier, EPA used highly conservative assumptions for the dietary food exposure assessment. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to tetrahydrofurfuryl alcohol in drinking water. EPA used similarly conservative assumptions to assess residential exposures of children to tetrahydrofurfuryl alcohol. These assessments will not underestimate the exposure and risks.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
1.
2.
3.
Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined chronic food, water, and short-term residential exposures result in aggregate MOEs of 13,100 for adults and 9,800 for children 1-2 years old. Because EPA's level of concern for tetrahydrofurfuryl alcohol is a MOE of 1,000 or below, these MOEs are not of concern.
4.
An intermediate-term adverse effect was identified; however, tetrahydrofurfuryl alcohol is not contained in any pesticide products registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for tetrahydrofurfuryl alcohol.
5.
6.
An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.
Therefore, the exemption from the requirement of a tolerance under 40 CFR 180.1263 is amended to add exemption from the requirement of a tolerance for residues of tetrahydrofurfuryl alcohol (CAS Reg. No. 97-99-4) when used as an inert ingredient (solvent) in herbicides applied to wheat, buckwheat, barley, oats, rye, sorghum, triticale, rice and wild rice prior to the pre-boot stage; use on canola to the early bolting stage; use on soybeans up to the bloom stage; and two applications to field corn and popcorn up to 36 inches tall (V8 stage).
This final rule establishes exemptions from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as
This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
(d) For use in herbicides with one application to wheat, buckwheat, barley, oats, rye, sorghum, triticale, rice, and wild rice prior to the pre-boot stage.
(e) For use in herbicides with two applications to field corn and popcorn up to 36 inches tall (V8 stage).
(f) For use in herbicides with two applications to canola prior to the early bolting stage.
(g) For use in herbicides with two applications to soybeans prior to the bloom growth stage.
Agricultural Marketing Service, USDA.
Proposed rule.
This proposed rule invites comments on a recommendation from the Citrus Administrative Committee (Committee) to relax the minimum grade requirements for oranges and tangerines, remove grade and size requirements for Ambersweet and Temple oranges, and simplify the tables outlining the grade and size requirements for interstate and export shipments currently prescribed under the marketing order for oranges, grapefruit, tangerines, and pummelos grown in Florida. A corresponding change would be made to the grapefruit import regulation as required by section 8e of the Agricultural Marketing Agreement Act of 1937.
Comments must be received by November 19, 2018.
Interested persons are invited to submit written comments concerning this rule. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or internet:
Abigail Campos, Marketing Specialist, or Christian D. Nissen, Regional Director, Southeast Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (863) 324-3375, Fax: (863) 291-8614, or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
This action, pursuant to 5 U.S.C. 553, proposes amendments to regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This proposed rule is issued under Marketing Order No. 905, as amended (7 CFR part 905), regulating the handling of oranges, grapefruit, tangerines, and pummelos grown in Florida. Part 905 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the Order and is comprised of producers and handlers of citrus operating within the area of production, and a public member.
This rule is also issued under section 8e of the Act, which provides that whenever certain specified commodities, including grapefruit, are regulated under a Federal marketing order, imports of these commodities into the United States are prohibited unless they meet the same or comparable grade, size, quality, or maturity requirements as those in effect for the domestically produced commodities.
The Department of Agriculture (USDA) is issuing this proposed rule in conformance with Executive Orders 13563 and 13175. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this proposed rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).
This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
There are no administrative procedures that must be exhausted prior to any judicial challenge to the provisions of import regulations issued under section 8e of the Act.
This proposed rule invites comments on changes to the grade and size requirements under the Order. This proposal would relax the minimum grade requirements for oranges and Fall-glo, Sunburst, and Honey tangerines from U.S. No. 1 to U.S. No. 2. This action would also remove grade and size requirements for Ambersweet and Temple oranges and simplify the tables outlining the grade and size requirements for interstate and export shipments. These actions would maximize shipments by allowing more citrus to be shipped to the fresh market and would help increase returns to growers and handlers. These changes
Section 905.52 provides authority to establish minimum grade requirements for Florida citrus. Section 905.306 specifies, in part, the minimum grade requirements for citrus. Requirements for domestic shipments are specified in § 905.306 in Table I of paragraph (a) and for export shipments in Table II of paragraph (b). Minimum grade and size requirements for grapefruit imported into the United States are currently in effect pursuant to § 944.106.
The Committee met on April 26, 2018, and discussed ways to provide additional supplies of Florida citrus to the marketplace and increase grower and handler returns. Committee members recognized that with the ongoing impacts of citrus greening, some adjustments should be made to assist growers and handlers and provide for the utilization of additional volume of Florida citrus in the fresh market.
Citrus greening has caused the steady decline in Florida citrus production and has spread to all citrus producing counties in Florida. From the 2011-12 to the 2016-17 season, citrus greening has reduced Florida's orange production by 53 percent and tangerine production by 67 percent. During the same period, fresh shipments have declined by 54 percent for oranges and 80 percent for tangerines.
The industry suffered additional production losses as a result of damage from Hurricane Irma in September 2017. According to USDA`s National Agricultural Statistics Service (NASS), production for the 2016-17 season totaled 68.8 million boxes for oranges and 1.6 million boxes for tangerines. For the 2017-18 season, the forecasted production is expected to decrease by 34 percent for oranges and 53 percent for tangerines. Also, the citrus trees may take several seasons to recover from the hurricane damage, further impacting production and supply.
Given the decrease in production, the Committee recommended relaxing the minimum grade requirements for oranges and Fallglo, Sunburst, and Honey tangerines from U.S. No. 1 to U.S. No. 2. During the discussion of this change, one Committee member stated the reduction in grade could help address the limited volumes of fruit available in the market. It was also stated that there was a good fresh juice market for the U.S. No. 2 orange and that this change could help promote the sale of more oranges for the fresh juice market.
For tangerines, it was stated that the very limited volume of tangerines being produced in Florida was causing a supply concern for shippers. Members agreed that lowering the grade for tangerines would promote increased shipments.
The Committee believes relaxing the grade from U.S. No. 1 to U.S. No. 2 for oranges and Fallglo, Sunburst, and Honey tangerines would allow growers and handlers to utilize a greater percentage of the crop and would make more fruit available for shipment. By implementing this change, the industry would be able to put an additional 300,000 cartons or more into the fresh market, helping to maximize shipments and to increase grower and handler returns.
The Committee also discussed the limited production of Ambersweet and Temple oranges (also known as Royal tangerines). In the past, the Committee has considered removing the grade and size requirements for varieties with limited commercial value due to the very limited supplies available for shipment. Last season, Ambersweet oranges accounted for 4,280 cartons and Temple oranges accounted for a total of 40,227 cartons sold. Given the decline in production, the Committee recommended removing restrictions on grade and size for Ambersweet and Temple oranges to maximize remaining shipments.
The Committee also recommended simplifying Table I and Table II in § 905.306, which outline the grade and size requirements for interstate and export shipments, to have them better reflect current industry requirements. Over the past few years, the Committee has made ongoing changes to both grade and size for a number of Florida citrus varieties. These changes have moved grade and size requirements toward greater commonality for both oranges and grapefruit.
With the grade change considered above, there would be no differences in grade and size requirements for the various types and varieties of oranges listed in the table. Therefore, the Committee recommended that “Early and midseason” oranges be consolidated with “Navel” and “Valencia and other late type” oranges into one “Oranges” classification. For grapefruit, the grade and size requirements for the two listed categories are already the same. “Seedless, red” and “Seedless, except red” would be combined into one “Grapefruit, seedless” classification.
In addition, the Committee recommended removing the “Regulation Period” column from the two tables. With the exception of the dates listed in Table I for Valencia and other late type oranges, the various dates listed are no longer applicable and are not reflective of the current industry. The grade change proposed for oranges would also negate the need for the current dates listed for Valencia and other late type oranges. The Committee made these recommendations to simplify the tables to reflect changes in the industry.
Section 8e of the Act provides that when certain domestically produced commodities, including grapefruit, are regulated under a Federal marketing order, imports of that commodity must meet the same or comparable grade, size, quality, and maturity requirements. Because this proposed rule would combine “Seedless, red” and “Seedless, except red” into one classification for grapefruit in the two domestic handling regulation tables as well as remove the “Regulation Period” column from those tables, a corresponding change to the table in the grapefruit import regulations would be required.
Further, two minor administrative changes would be made to § 944.106. In § 944.106(c), the reference to “§ 905.306” would be revised to read “§ 905.306(a) through (d)” so that the requirements specifically applicable to imports are more clearly defined. Additionally, § 944.106(d) would be updated to reflect the revised name of the Agricultural Marketing Service (AMS) program area that oversees federal marketing orders.
The Committee also recommended establishing new reporting requirements under the Order. That change is being considered under a separate rulemaking action.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 20 handlers of Florida citrus who are subject to regulation under the Order and approximately 500 citrus producers in the regulated area. There are approximately 50 citrus importers. Small agricultural service firms are defined by the Small Business
According to data from NASS, the industry, and the Committee, the weighted average f.o.b. price for Florida citrus for the 2016-17 season was approximately $15.20 per carton with total shipments of 12.6 million cartons. Using the number of handlers, and assuming a normal distribution, the majority of handlers have average annual receipts of more than $7,500,000 ($15.20 times 12.6 million equals $191,520,000 divided by 20 handlers equals $9,576,000 per handler).
In addition, based on the NASS data, the weighted average grower price for the 2016-17 season was around $8.30 per carton of citrus. Based on grower price, shipment data, and the total number of Florida citrus growers, and assuming a normal distribution, the average annual grower revenue is below $750,000 ($8.30 times 12.6 million cartons equals $104,580,000 divided by 500 growers equals $209,160 per grower).
South Africa, Peru, and Mexico are the major grapefruit-producing countries exporting grapefruit to the United States. In 2016, shipments of grapefruit imported into the United States totaled approximately 24,000 metric tons. Information from USDA's Foreign Agricultural Service indicates that the dollar value of imported fresh grapefruit was approximately $11.2 million in 2016. Using this value and the number of importers (approximately 50), most importers would have annual receipts of less than $7,500,000 for grapefruit.
Based on the previously described estimates, the majority of handlers of Florida citrus may be classified as large entities, while the majority of growers and importers may be classified as small entities.
This proposed rule would relax the minimum grade requirements for oranges and tangerines from U.S. No. 1 to U.S. No. 2, remove grade and size requirements for Ambersweet and Temple oranges, and simplify the tables outlining the grade and size requirements for interstate and export shipments. These changes would help maximize shipments by allowing more citrus to be shipped to the fresh market and would provide some additional fruit to address the losses resulting from citrus greening and the September 2017 hurricane. This proposed rule would revise § 905.306. Authority for this change is provided in § 905.52. This proposed rule would also change § 944.106 in the grapefruit import regulation and is required by section 8e of the Act.
This action is not expected to increase the costs associated with the Order's requirements or the grapefruit import regulation. Rather, it is anticipated that this action would have a beneficial impact. Reducing the grade requirements would make additional fruit available for shipment to the fresh market, provide an outlet for fruit that may otherwise go unharvested, and afford more opportunity to meet consumer demand. These changes would provide additional fruit to fill the shortage caused by citrus greening and by Hurricane Irma. By maximizing shipments, this action would help provide additional returns to growers and handlers. Further, removing the grade and size requirements for Ambersweet and Temple oranges would also help maximize shipments of these varieties impacted by declining production.
The benefits of this rule would also be equally available to all growers, handlers, and importers, regardless of their size.
An alternative to this action would be to maintain the current minimum grade requirements for domestic shipments of oranges and tangerines. However, leaving the requirements unchanged would not make additional fruit available for shipment. Following the significant damage experienced by the industry from citrus greening and the September 2017 hurricane, maximizing shipments would help provide additional returns to growers and handlers. Therefore, this alternative was rejected.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0189, Fruit Crops. No changes in those requirements are necessary as a result of this action. Should any changes become necessary, they would be submitted to OMB for approval.
This proposed rule will not impose any additional reporting or recordkeeping requirements on either small or large Florida citrus handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
In addition, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.
The Committee's meeting was widely publicized throughout the citrus industry, and all interested persons were invited to attend the meeting and participate in Committee deliberations. Like all Committee meetings, the April 26, 2018, meeting was a public meeting, and all entities, both large and small, were able to express their views on this issue. Interested persons are invited to submit comments on this proposed rule, including the regulatory and information collection impacts of this action on small businesses.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
In accordance with section 8e of the Act, the United States Trade Representative has concurred with the issuance of this proposed rule.
A 30-day comment period is provided to allow interested persons to respond to this proposal. All written comments timely received will be considered before a final determination is made on this matter.
Grapefruit, Marketing agreements, Oranges, Pummelos, Reporting and recordkeeping requirements, Tangelos, Tangerines.
Avocados, Food grades and standards, Grapefruit, Grapes, Imports, Kiwifruit, Limes, Olives, Oranges.
For the reasons set forth in the preamble, parts 905 and 944 are proposed to be amended as follows:
7 U.S.C. 601-674.
(a) No handler shall ship between the production area and any point outside thereof, in the 48 contiguous States and the District of Columbia of the United States, any variety of fruit listed in column (1) of Table I to paragraph (a), except for Ambersweet and Temple, unless such variety meets the applicable minimum grade and size (with tolerances for size as specified in paragraph (c) of this section) specified for such variety in columns (2) and (3) of Table I to paragraph (a):
(b) No handler shall ship to any destination outside the 48 contiguous States and the District of Columbia of the United States any variety of fruit listed in column (1) of Table II to paragraph (b), except for Ambersweet and Temple, unless such variety meets the applicable minimum grade and size (with tolerances for size as specified in paragraph (c) of this section) specified for such variety in columns (2) and (3) of Table II to paragraph (b):
The revisions to read as follows:
(a) * * *
(c) Terms and tolerances pertaining to grade and size requirements, which are defined in the United States Standards for Grades of Florida Grapefruit (7 CFR 51.750-51.784), and in Marketing Order No. 905 (7 CFR 905.18 and 905.306(a) through (d)), shall be applicable herein.
(d) The Federal or Federal-State Inspection Service, Specialty Crops Program, Agricultural Marketing Service, United States Department of Agriculture, is designated as the governmental inspection service for certifying the grade, size, quality, and
Securities and Exchange Commission.
Proposed rule; reopening of comment period; request for additional comment.
The Securities and Exchange Commission (“Commission”) is reopening the comment period and requesting additional comment (including potential modifications to proposed rule language) on the following: Proposed amendments and new rules that would establish capital and margin requirements for security-based swap dealers (“SBSDs”) and major security-based swap participants (“MSBSPs”) that do not have a prudential regulator, establish segregation requirements for SBSDs, establish notification requirements for SBSDs and MSBSPs relating to segregation, and raise minimum net capital requirements and establish liquidity requirements for broker-dealers permitted to use internal models when computing net capital (“ANC broker-dealers”). The Commission also is reopening the comment period and requesting additional comment on proposed amendments that would establish the cross-border treatment of security-based swap capital, margin, and segregation requirements; and a proposed amendment that would establish an additional capital requirement for SBSDs that do not have a prudential regulator.
The comment periods for portions of the proposed rules published Nov. 23, 2012 (77 FR 70213); May 23, 2013 (78 FR 30967); and May 2, 2014 (79 FR 25193), are reopened. Comments should be submitted by November 19, 2018.
Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
Studies, memoranda, or other substantive items may be added by the Commission or staff to the comment file during this rulemaking. A notification of the inclusion in the comment file of any such materials will be made available on the Commission's website. To ensure direct electronic receipt of such notifications, sign up through the “Stay Connected” option at
Michael A. Macchiaroli, Associate Director, at (202) 551-5525; Thomas K. McGowan, Associate Director, at (202) 551-5521; Randall W. Roy, Deputy Associate Director, at (202) 551-5522; Sheila Dombal Swartz, Senior Special Counsel, at (202) 551-5545; Timothy C. Fox, Branch Chief, at (202) 551-5687; Valentina Minak Deng, Special Counsel, at (202) 551-5778; or Nina Kostyukovsky, Attorney Advisor, at (202) 551-8833, Division of Trading and Markets, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-7010.
In October 2012, the Commission proposed amendments and new rules to: (1) Establish capital and margin requirements for SBSDs and MSBSPs that do not have a prudential regulator
In addition, in May 2013, the Commission proposed provisions to establish the cross-border treatment of security-based swap capital, margin, and segregation requirements.
Finally, in April 2014, the Commission proposed an additional nonbank SBSD capital requirement.
In the releases publishing the
Since publication of the
The Commission has carefully considered the comment letters, and the Commission believes it is prudent to reopen the comment period for the
The Commission renews its request for comment on all aspects of the
1. The
• The greater of the total margin required to be delivered by the nonbank SBSD with respect to security-based swap transactions cleared for security-based swap customers at a clearing agency or the amount of the deductions (haircuts) that would apply to the cleared security-based swap positions of the security-based swap customers pursuant to the proposed capital requirements; and
• The total margin amount calculated by the nonbank SBSD with respect to non-cleared security-based swaps pursuant to the proposed margin rule.
a. The Commission requests comment and supporting data on the potential minimum net capital amounts that would be required of nonbank SBSDs as a result of the requirement, as proposed. How would those potential minimum net capital amounts compare with the amounts of capital currently maintained by entities that may register as nonbank SBSDs?
b. One commenter suggested that the Commission modify its proposed definition of the
Would rule language as described below effect this potential modification to the rule text in the
The potential modifications to paragraph (c)(17) of Rule 15c3-1 would provide that the term
Similarly, the potential modifications to paragraph (c)(6) of Rule 18a-1 would provide that the term
2. The
One commenter opposed this proposal stating that the requirement would “harm customers because it would provide an incentive for the collection of margin by nonbank SBSDs beyond the amount determined by the clearing agency.”
Would rule language as described below effect this potential modification
The potential modifications to paragraph (c)(2)(xv)(A) of Rule 15c3-1 would provide the following deduction from net worth in lieu of collecting collateral for cleared security-based swaps and swap transactions: (
Similarly, the potential modifications to paragraph (c)(1)(ix)(A) of Rule 18a-1 would provide the following deduction from net worth in lieu of collecting collateral for security-based swaps and swap transactions: (
3. The
a. Commenters requested that nonbank SBSDs be permitted to apply the credit risk charge to other types of counterparties.
b. The Commission requests comment on whether the rule should establish a threshold for uncollected margin above which the use of the credit risk charge would not be permitted. Should there be a threshold when the aggregate amount of uncollected margin across all counterparties exceeds a level of the nonbank SBSD's tentative net capital? Should the threshold apply to the aggregate amount of uncollected initial
c. The potential modifications to the rule text in the
The potential modifications to paragraph (a)(7) of Rule 15c3-1 would provide: In accordance with Appendix E to this section (§ 240.15c3-1e), the Commission may approve, in whole or in part, an application or an amendment to an application by a broker or dealer to calculate net capital using the market risk standards of appendix E to compute a deduction for market risk on some or
Similarly, the potential modifications to paragraph (a)(2) of Rule 18a-1 would provide: In accordance with paragraph (d) of this section, the Commission may approve, in whole or in part, an application or an amendment to an application by a security-based swap dealer to calculate net capital using the market risk standards of paragraph (d) to compute a deduction for market risk on some or all of its positions, instead of the provisions of paragraphs (c)(1)(iv), (vi), and (vii) of this section, and § 240.18a-1b, and using the credit risk standards of paragraph (d) to compute a deduction for certain security-based swap and swap transactions, as specified in this paragraph, instead of the provisions of paragraphs (c)(1)(iii), (c)(1)(ix)(B)(
4. The
a. Commenters argued that the charge would discourage the use of segregation under Section 3E(f) of the Act,
b. The Commission is considering providing guidance on ways a nonbank SBSD could structure the account control agreement to meet a requirement that the nonbank SBSD have the same control over the collateral as would be the case if the nonbank SBSD controlled the collateral directly. In developing the guidance on ways this requirement could be met, the Commission asks commenters to address whether the agreement between the nonbank SBSD, counterparty, and the third-party custodian should: (1) Provide that the collateral will be released promptly and directed in accordance with the instructions of the nonbank SBSD upon the receipt of an effective notice from the nonbank SBSD; (2) provide that when the counterparty provides an effective notice to access the collateral the nonbank SBSD will have sufficient time to challenge the notice in good faith and that the collateral will not be released until a prior agreed-upon condition among the three parties has occurred; and (3) give priority to an effective notice from the nonbank SBSD over an effective notice from the counterparty, as well as priority to the nonbank SBSD's instruction about how to transfer the collateral in the event the custodian terminates the account control agreement? Are there any other provisions regarding the account control agreement that the Commission should address to assist nonbank SBSDs in structuring the agreements to meet a requirement in a rule that the nonbank SBSD have the same control over the collateral as would be the case if the nonbank SBSD controlled the collateral directly?
c. The potential modification to the rule text in the
The potential modifications to paragraph (c)(2)(xv)(B) of Rule 15c3-1 would provide the following deductions from net worth in lieu of collecting collateral for security-based swap and swap transactions: (
Similarly, the potential modifications to paragraph (c)(1)(ix) of Rule 18a-1 would provide the following deductions from net worth in lieu of collecting collateral for security-based swap and swap transactions: (
5. The
6. The
Some commenters argued that the Commission should approve a uniform initial margin model because it would reduce counterparty disputes and increase efficiency.
Would rule language as described below effect this potential modification to the rule text in the
The potential modifications to paragraph (d)(2)(i) of Rule 18a-3 would provide: For security-based swaps other than equity security-based swaps, a security-based swap dealer may apply to the Commission for authorization to use a model to compute the margin amount required by paragraph (c)(1)(i)(B) of this section and to compute the deductions required by paragraph § 240.15c3-1(c)(2)(xv) or § 240.18a-1(c)(1)(ix), as applicable, subject to the application process in § 240.15c3-1e or § 240.18a-1(d), as applicable. The model must use a ninety-nine percent (99%), one-tailed confidence level with price changes equivalent to a ten business-day movement in rates and prices, and must use risk factors sufficient to cover all the material price risks inherent in the positions for which the margin amount or deductions are being calculated, including foreign exchange or interest rate risk, credit risk, equity risk, and commodity risk, as appropriate. Empirical correlations may be recognized by the model within each broad risk category, but not across broad risk categories.
7. The
Some commenters encouraged the Commission to adopt a threshold below which initial margin need not be collected and noted that the prudential regulators and the CFTC established a $50 million threshold (consistent with the recommendation of an international standard setting body).
Would rule language as described below effect this potential modification to the rule text in the
The potential modifications to paragraph (c)(1)(iii)(E) of Rule 18a-3 would provide that an SBSD may elect not to collect the amount required under paragraph (c)(1)(ii)(B) of this section to the extent that the amount does not exceed the lesser of: (
8. As noted above, the
A commenter argued that Alternative A was the preferred approach because requiring SBSDs to collect initial margin from other SBSDs would curtail the use of non-cleared security-based swaps for hedging, which would disrupt key financial services, such as those that facilitate the availability of home loans and corporate finance.
a. The Commission requests comment and supporting data that would assist in the quantification of the economic impacts of Alternatives A and B. The
The
Finally, the
b. If Alternative A is adopted, should the exception apply to a broader class of entities than just other SBSDs? Should it apply if the nonbank SBSD's counterparty is an SBSD, broker-dealer, bank, futures commission merchant, foreign bank, or foreign dealer? The purpose of adopting Alternative A with a modification to apply the exception to a broader class of counterparties would be to promote the liquidity of nonbank SBSDs and other market participants by reducing the amount of capital they must post as initial margin to counterparties.
Would rule language as described below effect Alternative A with the potential modification to expand the range of entities from which initial margin need not be collected? If not, please explain why and suggest alternative rule language. If the Commission were to use the language described below, would it strike an appropriate balance in terms of promoting the liquidity of nonbank SBSDs and other market participants and addressing commenters' concerns about building up systemic risk? If not, please explain why and suggest alternative rule language that could more effectively and efficiently strike the balance and achieve the objective.
The potential modifications to paragraph (c)(1)(iii)(B) of Rule 18a-3 would provide that the requirements of paragraph (c)(1)(ii)(B) of this section do not apply to an account of a counterparty that is a security-based swap dealer, swap dealer, broker or dealer, futures commission merchant, bank, foreign bank, or a foreign broker or dealer.
9. In response to the
a. The Commission requests comment on whether swaps should be permitted to be held in a security-based swap account at an entity that is registered as a broker-dealer, nonbank SBSD, and swap dealer to provide a means to portfolio margin security-based swaps with swaps and related cash market and listed options positions. The Commission also requests comment on whether security-based swaps should be permitted to be held in a swap account at an entity that is registered as an FCM, swap dealer, and nonbank SBSD to provide a means to portfolio margin security-based swaps with swaps and related futures positions.
b. The Commission requests comment on whether swaps should be permitted to be held in a security-based swap
c. The Commission requests comment on how security-based swaps, swaps, cash market and listed options positions, and collateral held in a security-based swap account at an entity registered as a broker-dealer, nonbank SBSD, and swap dealer would be treated in a liquidation proceeding. The Commission requests comment on how security-based swaps, swaps, futures positions, and collateral held in a swap account at an entity registered as an FCM, swap dealer, and nonbank SBSD would be treated in a liquidation proceeding. Would the treatment be different if the entity was also registered as a broker-dealer? The Commission requests comment on how swaps and security-based swaps held in a security-based swap account at an entity registered as an SBSD and swap dealer would be treated in a liquidation proceeding and how security-based swaps and swaps held in a swap account at such an entity would be treated in a liquidation proceeding.
For each of the four scenarios described above, what steps should be taken to provide protections to the accountholders? What rights (including rights under the bankruptcy laws) might accountholders have to waive? Should there be limits on the types of counterparties that would be permitted to waive these rights? Should the rule require the nonbank SBSD to provide complete and accurate disclosures about the treatment of assets in a liquidation, bankruptcy, or similar proceeding under each of the scenarios described above so that accountholders and prospective accountholders can make informed decisions about the type of portfolio margin account they want to use and about waiving any rights with respect to the account?
d. The scenarios described above include permitting: (1) An entity registered as a broker-dealer, nonbank SBSD, and swap dealer to hold swaps in a security-based swap account to provide a means to portfolio margin security-based swaps with swaps and related cash market and listed options positions; and (2) an entity that is registered as an SBSD and swap dealer (but not as an FCM or broker-dealer) to hold swaps in a security-based swap account to provide a means to portfolio margin security-based swaps and swaps in a security-based swap account and to use a model to determine portfolio margin requirements for security-based swaps and swaps that reference equity securities, provided the accounts do not hold cash market equity and listed options positions.
Would rule language as described below effect these approaches to implement portfolio margining of swaps in a security-based swap account? If not, please explain why and suggest alternative rule language. If the Commission were to use the language described below, would it strike an appropriate balance in terms of achieving the objectives of the proposed rules and addressing commenters' requests to permit portfolio margining of swaps and security-based swaps? If not, please explain why and suggest alternative rule language that could more effectively and efficiently strike the balance and achieve the objective.
The potential modifications to paragraph (a)(3) of Appendix A to Rule 15c3-1 would provide: The term
The potential modifications to paragraph (a)(4) of Appendix A to Rule 15c3-1 would also provide: The term
The potential modifications to paragraph (a)(3) of Appendix A to Rule 18a-1 would provide: The term
The potential modifications to paragraph (a)(4) of Appendix A to Rule 18a-1 would provide: The term
The potential modifications to paragraph (d)(2)(ii) of Rule 18a-3 would provide: Notwithstanding paragraph (d)(2)(i) of this section, a security-based swap dealer that is not registered as a broker or dealer pursuant to Section 15(b) of the Act (15 U.S.C. 78o(b)) may apply to the Commission for authorization to use a model to compute the margin amount required by paragraph (c)(1)(i)(B) of this section and to compute the deductions required by paragraph § 240.18a-1(c)(1)(ix) for equity security-based swaps and equity swaps, subject to the application process and model requirements of
10. Section 3E(f) of the Act provides that a counterparty to a non-cleared security-based swap with an SBSD can require that initial margin be segregated at a third-party custodian or waive segregation.
a. The Commission received a number of comments asking technical questions about how the proposed omnibus segregation requirements would operate in the context of security-based swap transactions, including specific questions about the computation of the reserve formula, and what types of hedging would be permitted under the proposed definition of “excess securities collateral.”
b. The
c. The
11. The Commission received a comment that the broker-dealer customer protection rule (Rule 15c3-3) should be amended to take into account margin that is posted at a clearing agency by broker-dealers not registered as SBSDs.
12. The
The Commission requests comment on how initial margin posted by an SBSD to a bank SBSD to hedge a transaction with a security-based swap customer should be treated for purposes of the possession or control and customer reserve requirements in the
Would rule language as described below effect this potential modification to the rule text in the
The potential modifications to paragraph (p)(1)(ii) of Rule 15c3-3 would provide: The term
The potential modifications to paragraph (p)(1)(viii) of Rule 15c3-3 would provide: The term
The potential modifications to Line 16 of Exhibit B to Rule 15c3-3 would provide: Margin related to non-cleared security-based swap transactions in accounts carried for security-based swap customers required and held in a qualified registered security-based swap dealer account at another security-based swap dealer or at a third-party custodial account.
The potential modifications to paragraph (a)(2) of Rule 18a-4 would provide: The term
The potential modifications to paragraph (a)(10) of Rule 18a-4 would also provide: The term
The potential modifications to Line 14 of Exhibit A to Rule 18a-4 would provide: Margin related to non-cleared security-based swap transactions in accounts carried for security-based swap customers required and held in a qualified registered security-based swap dealer account at another security-based swap dealer or at a third-party custodial account.
13. The
The Commission requests comment on whether, for consistency with broker-dealers, the threshold applicable to SBSD customer reserve accounts held at a bank should be increased to fifteen percent (15%) of the bank's equity capital and whether any cash deposited with an affiliated bank should be excluded. The purpose would be to more closely align the proposed segregation requirements for security-based swaps with the existing customer reserve requirements in Rule 15c3-3, as amended in 2013. Should the fifteen percent (15%) threshold not apply if the SBSD is a bank and maintains the security-based swap customer reserve account itself rather than at an affiliated or non-affiliated bank? The purpose of this exception would be to accommodate a bank SBSD that holds the customer reserve account directly.
The changes discussed above would modify paragraph (c)(1) of proposed Rule 18a-4 and new paragraph (p)(3) of proposed Rule 15c3-3 to more closely align them with the 2013 amendments to Rule 15c3-3 and, with respect to proposed Rule 18a-4, establish an exception from the fifteen percent (15%) threshold for a bank SBSD that maintains the security-based swap customer reserve account itself. Would rule language as described below effect this potential modification to the rule text in the
The potential modifications to paragraph (p)(3)(i) of Rule 15c3-3 would provide: In determining the amount maintained in a special reserve account for the exclusive benefit of security-based swap customers, the security-based swap dealer must deduct (A) the amount of cash deposited with a single non-affiliated bank to the extent the amount exceeds fifteen percent (15%) of the equity capital of the bank as reported by the bank in its most recent Call Report or any successor form the bank is required to file by its appropriate federal banking agency (as defined by Section 3 of the Federal Deposit Insurance Act (12 U.S.C. 1813)); and (B) the total amount of cash deposited with an affiliated bank.
Similarly, the potential modifications to paragraph (c)(1)(i) of Rule 18a-4 would provide: In determining the amount maintained in a special reserve account for the exclusive benefit of security-based swap customers, the security-based swap dealer must deduct (A) the amount of cash deposited with a single non-affiliated bank to the extent the amount exceeds fifteen percent (15%) of the equity capital of the bank as reported by the bank in its most recent Call Report or any successor form the bank is required to file by its appropriate federal banking agency (as defined by Section 3 of the Federal Deposit Insurance Act (12 U.S.C. 1813)); and (B) for a security-based swap dealer for which there is not a prudential regulator, the total amount of cash deposited with an affiliated bank.
The potential modifications to paragraph (c)(1)(ii) of Rule 18a-4 would provide the following exception: A security-based swap dealer for which there is a prudential regulator need not take the deduction specified in paragraph (c)(1)(i)(D) of this section if it maintains the special reserve account for the exclusive benefit of security-based swap customers itself rather than at an affiliated or non-affiliated bank.
14. The
A number of commenters requested that the Commission consider consistency with the prudential regulators, international standards, and foreign regulators when making substituted compliance determinations with respect to the proposed nonbank SBSD capital requirements.
a. Commenters generally requested additional guidance regarding the criteria the Commission would consider when making substituted compliance determinations.
b. The Commission requests comment on the composition of the balance sheets of entities in foreign jurisdictions that may register as nonbank SBSDs. Are the assets and liabilities of these foreign entities similar to the assets and liabilities of U.S. broker-dealers that are subject to the net liquid assets test? If not, explain the differences.
c. The approach described in 14.a would modify Rule 3a71-6 (proposed as Exchange Act Rule 3a71-5 at 78 FR 30967, 31207-08) to describe factors that the Commission would consider in making a substituted compliance determination with respect to the proposed nonbank SBSD capital requirements.
The potential modifications to paragraph (d)(4) of Rule 3a71-6 would provide that substituted compliance is available with respect to: The capital requirements of Section 15F(e) of the Act (15 U.S.C. 78o-10(e)) and § 240.18a-1; provided, however, that prior to making such substituted compliance determination with respect to security-based swap dealers, the Commission intends to consider (in addition to any conditions imposed) whether the capital requirements of the foreign financial regulatory system are designed to help ensure the safety and soundness of registrants in a manner that is comparable to the applicable provisions arising under the Act and its rules and regulations.
15. In the Commission's release establishing the registration process for SBSDs and MSBSPs, the Commission provided that the compliance date for the SBSD and MSBSP registration requirements will be the later of: Six months after the date of publication in the
16. The
The Commission also requests comment and data on how the baseline of the economic analyses has changed since the publication of the
Commenters are asked to describe changes, if applicable, in: (1) The trading volumes in the relevant security-based swap and swap markets; (2) the regulatory structure of these markets; and (3) the number and types of entities that participate in these markets. Commenters also are asked to describe how those changes in the baseline would impact the potential benefits and costs—including the effects on efficiency, competition and capital formation—of the
Finally, the Commission requests comment on whether there are economic considerations apart from those discussed in the
By the Commission.
Department of Defense (DoD).
Proposed rule.
This rule describes procedures concerning trial by foreign criminal courts of, treatment in foreign prisons of, and the payment of counsel fees in certain civil cases for individuals referred to collectively in this rule as “dependents of DoD personnel.”
Comments must be received by December 18, 2018.
You may submit comments, identified by docket number and or RIN number and title, by any of the following methods:
•
•
Bart Wager, 703-571-9355.
Taken together, two statutes authorize the Secretary of Defense to issue legally binding guidelines on the Department of Defense. Under 10 U.S.C. 113, the Secretary has “authority, direction, and control” over the Department of Defense. The Department of Defense is an “executive department,” and the Secretary, as the head of an “executive department,” is empowered under 5 U.S.C. 301 to issue departmental regulations. The General Counsel of the Department of Defense has been delegated authority under Department of Defense Directive 5145.01, “General Counsel of the Department of Defense” (available at
This rule will update 32 CFR part 151, “Status of Forces Policies and Information” which was last updated on March 28, 1980. In 1985, Section 681 of Public Law 99-145 amended 10 U.S.C. 1037 to authorize the payment of counsel fees for those “not subject to the Uniform Code of Military Justice.” So this rule proposes to update and describe procedures concerning trial by foreign criminal courts of, treatment in foreign prisons of, and the payment of counsel fees in certain civil cases for command-sponsored and non-command sponsored dependents of Armed Forces members, and dependents of nationals and non-nationals of the United States who are serving with or accompanying the Military Services.
For dependents of DoD personnel, when those dependents are in a foreign country as a result of accompanying DoD personnel who are assigned duty in that country—it is Department of Defense policy to (a) maximize the exercise of U.S. jurisdiction to the extent permissible under applicable status of forces agreements or other forms of jurisdiction arrangements; (b) protect, to the maximum extent possible, the rights of dependents of DoD personnel who may be subject to criminal trial by foreign courts and imprisonment in foreign prisons; and (c) secure, where possible, the release of an accused to the custody of U.S. authorities pending completion of all foreign judicial proceedings.
A “designated commanding officer” (DCO) in each geographical area assigned to a Combatant Command is to (1) cooperate with the appropriate U.S. Chief of Mission and to the maximum extent possible, ensure that dependents of DoD personnel receive the same treatment, rights, and support as would be extended to U.S. Armed Forces members in comparable situations; (2) report informally and immediately to the General Counsel of the Department of Defense, the applicable geographic Combatant Commander, and the General Counsel and the Judge Advocate General of the respective Military Department, or, in the case of the Marine Corps, to the General Counsel of the Navy and the Staff Judge Advocate to the Commandant of the Marine
The proposed revisions are expected to cause no change to the burden or cost to dependents of DoD personnel. DoD is not changing the process for dependents to access these services and therefore does not anticipate a change in the population of eligible DoD dependents for these services. The Department will continue to provide relevant free legal services to the dependents of DoD personnel and acceptance of these legal services is entirely voluntary.
Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget (OMB) under the requirements of these Executive Orders.
This proposed rule is not expected to be subject to the requirements of E.O. 13771 (82 FR 9339, February 3, 2017) because this proposed rule is expected to be related to agency organization, management, or personnel.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1532) requires agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. This proposed rule will not mandate any requirements for State, local, or tribal governments, nor will it affect private sector costs.
The Department of Defense certifies that this proposed rule is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.
It has been determined that 32 CFR part 151 does not impose reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This proposed rule will not have a substantial effect on State and local governments.
Courts, Foreign relations, Military personnel, Prisons.
Accordingly, 32 CFR part 151 is proposed to be revised to read as follows:
10 U.S.C. chapter 47, 10 U.S.C. 1037.
This rule establishes policy, assigns responsibilities, and prescribes procedures, supplemental to those provided in DoD Instruction 5525.01 “Foreign Criminal and Civil Jurisdiction,” which will be made available at
(a) Command-sponsored and non-command sponsored dependents of Armed Forces members;
(b) Dependents of nationals and non-nationals of the United States who are serving with or accompanying the Military Services (referred to in this rule as “non-military DoD personnel”) in an area outside the United States and its territories and possessions, the Commonwealth of the Northern Mariana Islands, and the Commonwealth of Puerto Rico (referred to collectively in this rule as “outside the United States”);
(c) Dependents of DoD personnel serving under a U.S. Chief of Mission are not considered to be “dependents of DoD personnel” for the purposes of this rule.
This part applies to the Office of the Secretary of Defense, the Military Departments (including the Coast Guard at all times, including when it is a Service in the Department of Homeland Security by agreement with that Department), the Office of the Chairman of the Joint Chiefs of Staff and the Joint Staff, the Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD Field Activities, and all other organizational entities within the DoD.
These terms and their definitions are for the purposes of this part.
(a) The Department of Defense will, for dependents of DoD personnel when those dependents are in a foreign country accompanying DoD personnel who are assigned duty to that foreign country:
(1) Maximize the exercise of U.S. jurisdiction to the extent permissible under applicable status of forces agreements or other forms of jurisdiction arrangements.
(2) Protect, to the maximum extent possible, the rights of dependents of DoD personnel who may be subject to criminal trial by foreign courts and imprisonment in foreign prisons.
(3) Secure, where possible, the release of an accused to the custody of U.S. authorities pending completion of all foreign judicial proceedings.
(b) [Reserved]
(a) The Secretaries of the Military Departments ensure the adequacy of regulations in establishing an information and education policy on the laws and customs of the host country for dependents of DoD personnel assigned to foreign areas.
(b) For each country in their respective assigned area of responsibility (AOR), the geographic Combatant Commanders:
(1) Oversee Command implementation of the procedures in this part.
(2) Oversee DCO responsibilities, as described in paragraphs (c)(1) through (c)(4) of this section.
(c)
(1) Are responsible for formal invocation, where applicable, of the Senate resolution procedure in each foreign country where dependents of DoD personnel are present, consistent with the U.S. Senate Resolution of Ratification, with reservations, to the North Atlantic Treaty Organization Status of Forces Agreement, as agreed to by the Senate on July 15, 1953.
(2) In cooperation with the appropriate U.S. Chief of Mission and to the maximum extent possible, ensure dependents of DoD personnel receive the same treatment, rights, and support as Armed Forces members when in the custody of foreign authorities, or when confined (pre-trial and post-trial) in foreign penal institutions. DCOs will work with the appropriate U.S. Chief of Mission to make appropriate diplomatic contacts for dependents of DoD personnel who are not U.S. nationals.
(3) Report informally and immediately to the General Counsel of the Department of Defense, the applicable geographic Combatant Commander, and the General Counsel and the Judge Advocate General of the respective Military Department or, in the case of the U.S. Marine Corps (USMC), to the General Counsel of the Navy and the Staff Judge Advocate to the Commandant of the Marine Corps, or, in the case of the Coast Guard, the Judge Advocate General of the Coast Guard, about important new cases or important developments in pending cases. Important cases include, but are not limited to, instances of denial of the procedural safeguards under any applicable agreement; deficiency in the treatment or conditions of confinement in foreign penal institutions; or arbitrary denial of permission to visit dependents of DoD personnel.
(4) Take additional steps that may be authorized under relevant international agreements with the receiving State to implement the policy of this part.
(a)
(1) When the DCO determines, after a careful consideration of all the circumstances, including consultation with the Department of Justice where the matter involves possible prosecution in U.S civilian courts, that suitable action can be taken under existing U.S. laws or administrative regulations, the DCO may request the local foreign authorities to waive the exercise of criminal jurisdiction.
(2) When it appears possible that the accused may not obtain a fair trial, the commander exercising general court-martial jurisdiction over the command to which such persons are attached or with which they are associated will communicate directly with the DCO, reporting the full facts of the case. The DCO will then determine, in the light of legal procedures in effect in that country, if there is a risk that the accused will not receive a fair trial. If the DCO determines that there is a risk that the accused will not receive a fair trial, the DCO will decide, after consultation with the U.S. Chief of Mission, whether a request should be submitted through diplomatic channels to foreign authorities seeking their assurances of a fair trial for the accused or, in appropriate circumstances, that they waive the exercise of jurisdiction over the accused. If the DCO so decides, a recommendation will be submitted through the geographic Combatant Commander and the Chairman of the Joint Chiefs of Staff to the Secretary of Defense. Copies must be provided to the Secretary concerned and the GC DoD.
(b)
(i) Unless directed by the DCO, trial observers are not required to attend all preliminary proceedings, such as scheduling hearings, but will attend the trial on the merits and other pre- and post-trial proceedings where significant procedural or substantive matters are decided.
(ii) Trial observer reports regarding dependents of DoD personnel will be handled and processed pursuant to DoD Instruction 5525.01(4)(b-c).
(2) The DCO, upon receipt of a trial observer report, will be responsible for determining whether:
(i) There was any failure to comply with the procedural safeguards secured by the pertinent status of forces agreement.
(ii) The accused received a fair trial under all the circumstances. Due regard should be given to those fair trial rights listed in DoD Instruction 5525.01 “Foreign Criminal and Civil Jurisdiction,” Enclosure 5, “Fair Trial Guarantees” that are relevant to the particular facts and circumstances of the trial. A trial will not be determined to be unfair merely because it is not conducted in a manner identical to trials held in the United States.
(A) If the DCO believes that the procedural safeguards specified in pertinent agreements were denied or that the trial was otherwise unjust, the DCO will submit a recommendation as to appropriate action to rectify the trial deficiencies and otherwise to protect the rights or interests of the accused. This recommendation must include a statement of efforts taken or to be taken at the local level to protect the rights of the accused.
(B) The DCO will submit the recommendation to the Secretary of Defense, through the Under Secretary of Defense for Policy (with an advance copy to the General Counsel of the Department of Defense); copies must be
(c)
(1)
(i) The sentence that is normally imposed includes confinement, whether or not such sentence is suspended;
(ii) Capital punishment might be imposed;
(iii) An appeal is made from any proceeding in which there appears to have been a denial of the substantial rights of the accused;
(iv) The case, although not within the criteria established in paragraphs (c)(1)(i) through (c)(1)(iii) of this section, is considered to have significant impact on U.S. interests, including upon the relations of the Armed Forces with the host country.
(2)
(3)
(ii) No funds will be provided under paragraph (c)(2) of this section to a plaintiff who, if successful, will receive an award, in whole or in part, from the United States.
(iii) As provided for in 10 U.S.C. 1037, a person on whose behalf a payment is made under this provision is not liable to reimburse the United States for that payment, unless he or she is responsible for the forfeiture of bail provided for him or her under this provision.
(d)
(e)
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard is proposing to establish a temporary, moving safety zone for all navigable waters within a 1000-yard radius of the National Aeronautics and Space Administration's (NASA's) crew module uprighting system test article while it is being tested in the territorial waters of the Gulf of Mexico off the coast of Galveston, TX. The safety zone is necessary to protect persons, vessels, and the marine environment from potential hazards created by vessels and equipment engaged in the crew capsule's at-sea testing. This proposed rulemaking would prohibit persons and vessels from being in the safety zone unless authorized by the Captain of the Port Sector Houston-Galveston or a designated representative. We invite your comments on this proposed rulemaking.
Comments and related material must be received by the Coast Guard on or before November 5, 2018.
You may submit comments identified by docket number USCG-2018-0962 using the Federal eRulemaking Portal at
If you have questions about this proposed rulemaking, call or email Lieutenant Collin Sykes, Eighth Coast Guard District, Waterways Management Division, U.S. Coast Guard; telephone 504-671-2119, email
The National Aeronautics and Space Administration's (NASA's) Orion program is evaluating an updated design to the crew module uprighting system (CMUS), the system of five airbags on top of the crew capsule that inflate upon splashdown. NASA tested the CMUS at the Neutral Buoyancy Lab at NASA's Johnson Space Center in Houston, and requested Coast Guard support for the at-sea uprighting tests. The at-sea testing will involve numerous surface vessels, divers, and remote-operated submarine vehicles, and features a rapid rotation of the Orion test article in a confined area and partially controlled environment. Due to the complexity of the test and proximity of the participants, unauthorized access by persons or vessels outside the scope of the test present a significant hazard to human life, vessels, and government property. The Captain of the Port Sector Houston-Galveston (COTP) has determined that this rule is needed to protect persons, vessels, and the marine environment on the navigable waters within the safety zone during the test.
The purpose of this rulemaking is to ensure the safety of persons, vessels, and the marine environment on the navigable waters within a 1000-yard radius of the CMUS test article before, during, and after the scheduled testing activities.
The Coast Guard is issuing this notice of proposed rulemaking (NPRM) with a 15-day prior notice and opportunity to comment pursuant to section (b)(3) of the Administrative Procedure Act (APA) (5 U.S.C. 553). Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good cause exists for publishing this NPRM with a 15-day comment period because it is impractical to provide a 30-day comment period. It is impracticable to publish an NPRM with a 30-day comment period because we must establish this temporary safety zone by November 28, 2018. A 15-day comment period would allow the Coast Guard to provide for public notice and comment, but also publish a rule, if adopted, soon enough that the length of the notice and comment period does not compromise public safety.
The COTP is proposing to establish a temporary, moving safety zone that would cover all navigable waters within 1000 yards of NASA's CMUS test article, which will be located in the territorial waters of the Gulf of Mexico off the coast of Galveston, TX. NASA anticipates that the testing activities will take place on approximately three days during the effective period, during daylight hours only. The effective period of this proposed rule covers a nine day window from November 28, 2018 through December 6, 2018, to allow for scheduling delays due to inclement weather or technical difficulties. On each of the approximately three days that the proposed rule would be enforced, the enforcement periods would begin approximately 2 hours before testing activities and last until approximately 2 hours after the testing activities. The COTP or a designated representative would inform the public through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs), and/or other means of public notice, as appropriate, at least 3 hours in advance of each enforcement period. Such notice of enforcement would also include more specific information regarding the location of the CMUS test article.
The duration of the proposed zone is intended to protect persons, vessels, and the marine environment on these navigable waters during the NASA testing activities. No vessel or person would be permitted to enter or remain in the safety zone without obtaining permission from the COTP or a designated representative. A designated representative is a Coast Guard Patrol Commander, including a Coast Guard coxswain, petty officer, or other officer operating a Coast Guard vessel, and a Federal, State, and local officer designated by or assisting the COTP in the enforcement of the safety zone. The Patrol Commander may be contacted on Channel 16 VHF-FM (156.8 MHz) by the call sign “PATCOM”. Vessels requiring entry into this safety zone must request permission from the COTP or a designated representative. They may be contacted on VHF-FM Channel 16. All persons and vessels permitted to enter this safety zone must transit at their slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative. The COTP or a designated representative will inform the public of the enforcement times, dates, and locations, for this safety zone through BNMs, LNMs, and/or MSIBs, as appropriate. The regulatory text we are proposing appears at the end of this document.
We developed this proposed rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location, and duration of the safety zone. Vessel traffic will be able to safely transit around this safety zone, which would affect a small, designated area off the coast of Galveston, TX, outside of the Houston Ship Channel and safety fairway during daylight hours on approximately three days. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the temporary safety zone may be small
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this proposed rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves a temporary, moving safety zone that would prohibit entry within 1000 yards of the CMUS test article during daylight hours on approximately three days in the Gulf of Mexico. Normally, such actions are categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A preliminary Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard is proposing to amend 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(d)
(2) To seek permission to enter, contact the COTP or a designated representative by VHF Channel 16.
(3) If granted permission to enter, all vessels must transit at their slowest safe speed and comply with all lawful orders or directions of the COTP or a designated representative.
(e)
Federal Communications Commission.
Petition for Reconsideration; correction.
The Federal Communications Commission (Commission) published a document in the
October 19, 2018.
Federal Communications Commission, 445 12th Street SW, Washington, DC 20554.
Michele Berlove, Wireline Competition Bureau, at: (202) 418-1477; email:
In the
Oppositions to the Petition must be filed on or before October 4, 2018. Replies to an opposition must be filed on or before October 15, 2018.
Rural Utilities Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, the United States Department of Agriculture's (USDA) Rural Utilities Service (RUS) invites comments on this information collection for which the Agency intends to request approval from the Office of Management and Budget (OMB).
Comments on this notice must be received by December 18, 2018.
Michele Brooks, Team Lead, Rural Development Innovation Center—Regulatory Team, USDA, 1400 Independence Avenue SW, STOP 1522, Room 5164, South Building, Washington, DC 20250-1522. Telephone: (202) 690-1078. Email:
The Office of Management and Budget's (OMB) regulation (5 CFR part 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies an information collection that RUS is submitting to OMB as a revision to an existing collection. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to: Michele Brooks, Team Lead, Rural Development Innovation Center—Regulatory Team, USDA, 1400 Independence Avenue SW, STOP 1522, Room 5164, South Building, Washington, DC 20250-1522. Telephone: (202) 690-1078. Email:
Copies of this information collection can be obtained from Robin M. Jones, Innovation Center, at (202) 772-1172, Email:
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
October 24, 2018, 10:00 a.m. EDT.
U.S. Chemical Safety Board, 1750 Pennsylvania Ave. NW, Suite 910, Washington, DC 20006.
Open to the public.
The Chemical Safety and Hazard Investigation Board (CSB) will convene a public meeting on Wednesday, October 24, 2018, at 10 a.m. EDT in Washington, DC, at the CSB offices located at 1750 Pennsylvania Avenue NW, Suite 910. The Board will discuss open investigations, the status of audits from the Office of the Inspector General, financial and organizational updates. New business will include an overview of items related to a new “Dust Hazards Perception Report,” a factual update on the CSB's ongoing Kuraray investigation, and a discussion and possible vote on a policy regarding employee participation in CSB investigations.
The meeting is free and open to the public. If you require a translator or interpreter, please notify the individual listed below as the
A conference call line will be provided for those who cannot attend in person. Please use the following dial-in number to join the conference:
The CSB is an independent federal agency charged with investigating incidents and hazards that result, or may result, in the catastrophic release of extremely hazardous substances. The agency's Board Members are appointed by the President and confirmed by the Senate. CSB investigations look into all aspects of chemical accidents and hazards, including physical causes such as equipment failure as well as inadequacies in regulations, industry standards, and safety management systems.
The time provided for public statements will depend upon the number of people who wish to speak. Speakers should assume that their presentations will be limited to three minutes or less, but commenters may submit written statements for the record.
Hillary Cohen, Communications Manager, at
United States Commission on Civil Rights.
Notice of Commission public briefing,
Friday, November 2, 2018, 9:00 a.m. ET.
Place: National Place Building, 1331 Pennsylvania Ave. NW, 11th Floor, Suite 1150, Washington, DC 20245 (Entrance on F Street NW).
Brian Walch, (202) 376-8371; TTY: (202) 376-8116;
The U.S. Commission on Civil Rights will hold a public briefing to evaluate federal civil rights enforcement, examining in particular Fiscal Years 2016 through 2018. With this assessment, the Commission asks: What are the key elements for effective civil rights enforcement? Do federal agencies have sufficient resources to fulfill their enforcement responsibilities? Most importantly, is the federal government satisfying its obligation to the American people to protect and vindicate their civil rights, including in education, housing, healthcare, employment, policing, the justice system, and other areas?
Commissioners will hear from current and former senior federal government officials, academic and legal experts, and advocates. We will also offer an open comment session in which members of the public will be able to address the Commission (see below).
The Commission will issue a report from this investigation in fall 2019, including findings and recommendations.
This briefing is open to the public. The event will also live-stream at
We will offer an open comment session in which members of the public will be able to address the Commission. Detailed information on this open comment session will be announced on the Commission's website (
In addition, the Commission welcomes the submission of additional material for consideration as we prepare our report. Please submit such information to
Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA) that a meeting of the West Virginia Advisory Committee to the Commission will convene by conference call at 12 p.m. (EST) on Friday, November 2, 2018. The purpose of the meeting is to discuss plans for preparing the Committee report on the collateral consequences of a felony record on West Virginians' access to employment, housing, professional licenses and public benefits.
Friday, November 2, at 12 p.m. EST.
Ivy Davis at
Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 1-877-604-9665 and conference call ID: 5788080. Please be advised that before placing them into the conference call, the conference call operator will ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the
Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-888-364-3109 and providing the operator with the toll-free conference call-in number: 1-877-604-9665 and conference call ID: 5788080.
Members of the public are invited to submit written comments. The comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, or emailed to Corrine Sanders at
Records and documents discussed during the meeting will be available for public viewing as they become available at
Bureau of the Census, Department of Commerce.
Notice of suspension of program.
This document serves as notice to state and local governments and to other federal agencies that beginning on January 1, 2019, the Bureau of the Census (Census Bureau) will suspend the Geographically Updated Population Certification Program for three years—the year preceding the decennial census, the decennial census year, and the year following it—to accommodate the 2020 Census operation. During this time, the Census Bureau will not provide the operations necessary to determine the updated April 1, 2010 census population and housing unit counts for entities that: Annex territory; incorporate or organize as counties; or incorporate or organize as boroughs, cities, towns, villages, townships, or other general purpose governments. However, the Census Bureau will consider all requests for population and housing count updates received in writing before January 1, 2019.
As of January 1, 2019, the Geographically Updated Population Certification Program will be suspended. It will remain suspended until December 31, 2021.
Mr. Darryl Cohen, Population Division, U.S. Census Bureau, 4600 Silver Hill Road, Washington, DC 20233, telephone (301) 763-2419, email
The Census Bureau first began to make updated decennial census count determinations to reflect geographic boundary changes in 1972 in response to the requests of local governments to establish eligibility for participation in the General Revenue Sharing Program, authorized under Public Law 92-512. At that time, the Census Bureau established a fee-for-service program enabling entities with annexations to obtain updated decennial census population counts that reflected the population living in the annexed areas. The Census Bureau also received funding from the U.S. Department of the Treasury to make those determinations for larger annexations that met prescribed criteria and for new incorporations. The General Revenue Sharing Program ended on September 30, 1986, but the certification program continued into 1988 with support for the Census Bureau. The program was suspended to accommodate the 1990 Census operations and resumed in 1992. The Census Bureau supported the program through fiscal year 1995 for cities with large annexations and through fiscal year 1996 for new incorporated places. The program was continued on a fee-for-service basis only until June 1, 1998, at which time it was suspended for the 2000 Census (see the
The Census Bureau is suspending the program for the year immediately preceding, the year of, and year following the 2020 Census to permit allocation of necessary resources to the decennial census. However, all requests for population and housing count updates received before January 1, 2019 will be considered. The Census Bureau will announce in a future
Authority to continue this program on a fee-for-service basis is contained in Title 13, United States Code, Section 8.
On June 27, 2017, in the U.S. District Court for the Southern District of Florida, Luis Antonio Urdaneta Pozo (“Pozo”) was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Pozo was convicted of knowingly and willfully exporting from
Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”)
BIS has received notice of Pozo's conviction for violating Section 38 of the AECA, and has provided notice and an opportunity for Pozo to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS has not received a submission from Pozo.
Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Pozo's export privileges under the Regulations for a period of 10 years from the date of Pozo's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Pozo had an interest at the time of his conviction.
Accordingly, it is hereby
A. Applying for, obtaining, or using any license, license exception, or export control document;
B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or engaging in any other activity subject to the Regulations; or
C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or from any other activity subject to the Regulations.
A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;
B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;
C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;
D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or
E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines
Applicable October 19, 2018.
Samuel Brummitt, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-7851.
On August 31, 2001, Co-Steel Raritan, Inc., GS Industries, Keystone Consolidated, Industries, Inc., and North Star Steel Texas, Inc. filed a petition seeking imposition of antidumping duties on imports of wire rod from Mexico.
The products covered by the
The products covered by this inquiry are wire rod with an actual diameter less than 4.75 mm and that are produced and/or exported to the United States by Deacero.
Commerce is conducting this anti-circumvention inquiry in accordance with section 781(c) of the Act. For a full description of the methodology underlying Commerce's preliminary determination,
As detailed in the Preliminary Decision Memorandum, we preliminarily determine, pursuant to section 781(c) of the Act, that wire rod with an actual diameter less than 4.75 mm produced and/or exported by Deacero, constitutes merchandise “altered in form or appearance in minor respects” that should be considered subject to the
As stated above, Commerce has made a preliminary affirmative finding of circumvention of the
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than 21 days after the publication of this preliminary determination in the
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 21 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
This determination is issued and published in accordance with sections 781(c) of the Act and 19 CFR 351.225(f).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) seeks public comment on any subsidies, including stumpage subsidies, provided by certain countries exporting softwood lumber or softwood lumber products to the United States during the period January 1, 2018, through June 30, 2018.
Comments must be submitted within 30 days after publication of this notice.
See the Submission of Comments section below.
Kristen Johnson or Eric B. Greynolds, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4793 or (202) 482-6071, respectively.
On June 18, 2008, section 805 of Title VIII of the Tariff Act of 1930 (the Softwood Lumber Act of 2008) was enacted into law. Under this provision, the Secretary of Commerce is mandated to submit to the appropriate Congressional committees a report every 180 days on any subsidy provided by countries exporting softwood lumber or softwood lumber products to the United States, including stumpage subsidies.
Commerce submitted its last subsidy report on June 20, 2018. As part of its newest report, Commerce intends to include a list of subsidy programs identified with sufficient clarity by the public in response to this notice.
Given the large number of countries that export softwood lumber and softwood lumber products to the United States, we are soliciting public comment only on subsidies provided by countries whose exports accounted for at least one percent of total U.S. imports of softwood lumber by quantity, as classified under Harmonized Tariff Schedule code 4407.1001 (which accounts for the vast majority of imports), during the period January 1, 2018, through June 30, 2018. Official U.S. import data published by the United States International Trade Commission's Tariff and Trade DataWeb indicate that four countries (Brazil, Canada, Germany, and Sweden) exported softwood lumber to the United States during that time period in amounts sufficient to account for at least one percent of U.S. imports of softwood lumber products. We intend to rely on similar previous six-month periods to identify the countries subject to future reports on softwood lumber subsidies. For example, we will rely on U.S. imports of softwood lumber and softwood lumber products during the period July 1, 2018, through December 31, 2018, to select the countries subject to the next report.
Under U.S. trade law, a subsidy exists where an authority: (i) Provides a financial contribution; (ii) provides any form of income or price support within the meaning of Article XVI of the GATT 1994; or (iii) makes a payment to a funding mechanism to provide a financial contribution to a person, or entrusts or directs a private entity to make a financial contribution, if providing the contribution would normally be vested in the government and the practice does not differ in substance from practices normally followed by governments, and a benefit is thereby conferred.
Parties should include in their comments: (1) The country which provided the subsidy; (2) the name of the subsidy program; (3) a brief description (no more than 3-4 sentences) of the subsidy program; and (4) the government body or authority that provided the subsidy.
As specified above, to be assured of consideration, comments must be received no later than 30 days after the publication of this notice in the
Commenters who do not have access to the internet may submit the original and one electronic copy of each set of comments by mail or hand delivery/courier.
All comments should be addressed to Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance, at U.S. Department of Commerce, Room 18022, 1401 Constitution Avenue NW, Washington, DC 20230.
Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.
Notice of availability of Errata for the final environmental impact report/environmental impact statement.
Notice is hereby given that the National Oceanic and Atmospheric Administration (NOAA) has published an errata document for the Final Environmental Impact Report/Environmental Impact Statement (FEIR/EIS) for a permit application to NOAA's Monterey Bay National Marine Sanctuary (MBNMS) submitted by California American Water Company (CalAm) to construct and operate Monterey Peninsula Water Supply Project, a reverse osmosis (RO) desalination facility project (Project) in Monterey County, California. A notice of availability (NOA) of the final EIR/EIS was published in the
This notice is applicable October 19, 2018.
Copies of the FEIR/EIS and the Errata document can be downloaded or viewed on the internet at
Karen Grimmer at 99 Pacific Ave., Bldg. 455a, Monterey, CA 93940, or call 831-647-4253, or email:
NOAA, as the Federal lead agency for purposes of the National Environmental Policy Act (NEPA), and the California Public Utilities Commission (CPUC), the state lead agency for purposes of the California Environmental Quality Act (CEQA), previously released a joint final environmental impact review/environmental impact statement (EIR/EIS) that analyzes the potential effects on the physical and human environment of the proposed Monterey Peninsula Water Supply Project.
The purpose of this notice is to inform the public that the errata document for the Final Environmental Impact Report/Environmental Impact Statement (FEIR/EIS) for the project is available for public inspection. It is available electronically on the website listed in the
16 U.S.C. 1431
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; proposed incidental harassment authorization; request for comments on proposed authorization and possible renewal.
NMFS has received a request from the Washington State Department of Transportation (WSDOT) for authorization to take marine mammals incidental to the US 101/Chehalis River Bridge-Scour Repair Project in Washington State. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on a possible one-year renewal that could be issued under certain circumstances and if all requirements are met, as described in
Comments and information must be received no later than November 19, 2018.
Comments should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service. Physical comments should be sent to 1315 East-West Highway, Silver Spring, MD 20910 and electronic comments should be sent to
Rob Pauline, Office of Protected Resources, NMFS, (301) 427-8401. Electronic copies of the application and supporting documents may be obtained online at:
The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other means of effecting the least practicable adverse impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.
The National Defense Authorization Act (Pub. L. 108-136) removed the small numbers and specified geographical region limitations indicated above and amended the definition of harassment as it applies to a military readiness activity.
To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321
This action is consistent with categories of activities identified in Categorical Exclusion B4 (incidental harassment authorizations with no anticipated serious injury or mortality) of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has preliminarily determined that the issuance of the proposed IHA qualifies to be categorically excluded from further NEPA review.
We will review all comments submitted in response to this notice prior to concluding our NEPA process or making a final decision on the IHA request.
On July 26, 2018, NMFS received a request from WSDOT for an IHA to take marine mammals incidental to US 101/Chehalis River Bridge-Scour Repair in the State of Washington. The application was deemed adequate and complete on September 21, 2018. WSDOT's request is for take of small numbers of harbor seal (
The proposed IHA would authorize work for the US 101/Chehalis River Bridge-Scour Repair Project in Washington State between July 15, 2019 and February 15, 2020. Vibratory pile driving will be required to remove and install timber piles, steel sheets and steel H-piles. Sound in the water from vibratory driving may result in behavioral harassment. NMFS previously issued an IHA to WSDOT to incidentally take five species of marine mammal by Level B harassment on October 18, 2017 (82 FR 50628; November 1, 2017). That IHA is valid from July 1, 2018 through June 30, 2019. However, WSDOT has made minor changes to the project plan and delayed the work by one year. Therefore, WSDOT has requested that NMFS re-issue the IHA with the dates changed to accommodate the analyzed work with minor modifications to the number of piles driven and removed as well as the number of animals authorized for take. No work was conducted or is planned to occur under the original IHA.The purpose of the US 101/Chehalis River Bridge-Scour Repair Project is to make the bridge foundation stable and protect the foundation from further scour. Bridge scour is the removal of sediment such as sand and gravel from around bridge abutments or piles. Scour, caused by swiftly moving water, can scoop out scour holes, compromising the integrity of a structure. WSDOT plans to remove debris from the scour area, fill the scour void under Pier 14 with cement (to protect the pilings from marine borers), fill the scour hole, and protect the pier with scour resistant material.
Note that WSDOT has made revisions to the number and types of piles that would be installed and removed under the proposed 2019 IHA. The first change is the removal of 44 timber piles (some of which may be treated with creosote) from the immediate vicinity of the scour repair project. Additionally, 18 sheet piles will be temporarily installed adjacent to Pier 14, instead of the 44 sheet piles originally proposed.
Due to NMFS and the U.S. Fish and Wildlife Service (USFWS) in-water work timing restrictions to protect Endangered Species Act (ESA)-listed salmonids, planned WSDOT in-water construction is limited each year to July 15 through February 15. For this project, in-water construction is planned to take place between July 15, 2019 and September 30, 2019. The proposed IHA would be effective from July 15, 2019 to February 15, 2020. The estimated maximum time period for pile installation and removal is 37 hours over 6 days (Table 1).
The US 101/Chehalis River Bridge is located in the City of Aberdeen, Grays Harbor County, Washington (Figure 1-1 in the IHA application). Grays Harbor is an estuarine bay located 45 miles (72 km) north of the mouth of the Columbia River, on the Southwest Pacific coast of Washington state. The bridge is located in Township 17 North, Range 9 West, Section 9, where the Chehalis River enters Grays Harbor. Land use in the Aberdeen area is a mix of residential, commercial, industrial, and open space and/or undeveloped lands (Figure 1-2 in the IHA application).
Vibratory hammers are commonly used in steel pile driving and removal when appropriate sediments are found at a specific project site. A pile is
Forty-four 14-inch diameter timber piles/stubs located immediately north of Pier 14 will be removed using a vibratory hammer. If necessary, some deteriorated piles may require cutting below the ground level to minimize turbidity. If use of a clamshell bucket is required due to pile breakage, turbidity curtains will be employed.
A steel template will be located adjacent to or attached to Pier 14. The template will likely be constructed using six steel H piles which will be installed using a vibratory hammer. Using the template as a guide, 18 sheet piles will be driven with a vibratory hammer into the substrate to form a temporary interlocked sheet pile wall shoring system around the scour repair area (Table 1). After the sheet piles have been installed, the template will be removed.
Once the shoring system is in place, cementitious material will be tremie pumped underwater inside the shoring system to fill the voids between the riverbed and the pier seal. A tremie is a large metal hopper and pipe used to distribute freshly mixed concrete over an underwater site. The foot of the pipe is kept below the concrete level, while the upper level of the concrete in the pipe is kept above the water level to prevent the water diluting the concrete. The concrete falls by gravity and is continuously placed until the shaft is full. This material will protect the untreated wood pier piling from marine borers. Following installation of the cementitious sealing material, the shoring system will be considered a permanent feature of the scour repair. The sheet piles will be cut off and removed to the level of final concrete placement. The final steps will be the placement of scour resistant material, such as rip rap, on and around the pier and in the scour hole to protect the pier from future erosion. The cutting of sheet piles and placement of rip rap is not anticipated to result in take.
Proposed mitigation, monitoring, and reporting measures are described in detail later in this document (please see
Sections 3 and 4 of the application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history, of the potentially affected species. Additional information regarding population trends and threats may be found in NMFS's Stock Assessment Reports (
Table 2 lists all species with expected potential for occurrence in the project location and summarizes information related to the population or stock, including regulatory status under the MMPA and ESA and potential biological removal (PBR), where known. For taxonomy, we follow Committee on Taxonomy (2017). PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS's SARs). While no mortality is anticipated or authorized here, PBR and annual serious injury and mortality from anthropogenic sources are included here as gross indicators of the status of the species and other threats.
Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS's stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. For some species, this geographic area may extend beyond U.S. waters. All managed stocks in this region are assessed in NMFS's U.S. 2017 SARs (
All species that could potentially occur in the proposed survey areas are included in Table 2.
Harbor seals haul out on rocks, reefs and beaches, and feed in marine, estuarine and occasionally fresh waters. Harbor seals display strong fidelity for haul out sites (Pitcher and Calkins 1979; Pitcher and McAllister 1981). Harbor seals in Grays Harbor are part of the Oregon/Washington Coast Stock. In Grays Harbor, pups are born from mid-April through July (WDFW 2012). Of the pinniped species that commonly occur within the region of activity, harbor seals are the most common and the only pinniped that breeds and remains in the inland marine waters of Washington year-round (Calambokidis and Baird 1994). Harbor seals are non-migratory; their local movements are associated with such factors as tides, weather, season, food availability and reproduction (Scheffer and Slipp 1944; Fisher 1952; Bigg 1969, 1981). They are not known to make extensive pelagic migrations, although some long-distance movements of tagged animals in Alaska (108 miles) and along the U.S. west coast (up to 342 miles) have been recorded (Pitcher and McAllister 1981).
In order to estimate abundance, aerial surveys of harbor seals in Oregon and Washington were conducted by the National Marine Mammal Laboratory (NMML) and the Oregon and Washington Departments of Fish and Wildlife (ODFW and WDFW) during the 1999 pupping season. Total numbers of hauled-out seals (including pups) were counted during these surveys. In 1999, the mean count of harbor seals occurring along the Washington coast was 10,430 (CV = 0.14) animals. In 1999, the mean count of harbor seals occurring along the Oregon coast and in the Columbia River was 5,735 (CV = 0.14) animals. Combining these counts results in 16,165 (CV = 0.10) harbor seals in the Oregon/Washington Coast stock. However, because the most recent abundance estimate is >8 years old, there is no current estimate of abundance available for this stock and the current population trend is unknown.
The nearest documented harbor seal haul out site to the US 101/Chehalis River Bridge is a low-tide haul out located seven miles to the west. According to Jeffries,
California sea lions are found along the west coast from the southern tip of Baja California to southeast Alaska. They breed mainly on offshore islands from Southern California's Channel
The Steller sea lion is a pinniped and the largest of the eared seals. Steller sea lion populations that primarily occur east of 144° W (Cape Suckling, Alaska) comprise the Eastern Distinct Population Segment (DPS), which was de-listed and removed from the Endangered Species List on November 4, 2013 (78 FR 66140). This stock is found in the vicinity of Grays Harbor. Steller sea lions congregate at rookeries in California, Oregon, Washington, and British Columbia for pupping and breeding from late May to early June (Gisiner 1985; NMFS 2016a). Rookeries are usually located on beaches of relatively remote islands, often in areas exposed to wind and waves, where access by humans and other mammalian predators is difficult (WDFW 1993).
The nearest documented Steller sea lion haul out sites to the U.S. 101 Chehalis River Bridge project site are at Split Rock, 35 miles north of the entrance to Grays Harbor; and at the mouth of the Columbia River, 46 miles south of the entrance to Grays Harbor (Jeffries,
During summer and fall, most whales in the Eastern North Pacific population feed in the Chukchi, Beaufort and northwestern Bering Seas. An exception to this is the relatively small number of whales (approximately 200) that summer and feed along the Pacific coast between Kodiak Island, Alaska and northern California (Calambokidis
Gray whales are known to use Grays Harbor. For example, during a 1996 survey 27 different whales were recorded in the Harbor. (Calambokidis and Guan 1997). However, between 1998 and 2010, gray whale numbers peaked in the spring followed by slightly lesser numbers in the fall in a study area that included Grays Harbor and coastal waters along the south Washington coast. Note, that much of the in-water pile driving work for the proposed action is likely to occur during summer months. (Calambokidis,
The harbor porpoise inhabits temporal, subarctic, and arctic waters. Harbor porpoise are known to occur year-round along the Oregon/Washington coast. Aerial survey data from coastal Oregon and Washington, collected during all seasons, suggest that harbor porpoise distribution varies by depth. Although distinct seasonal changes in abundance along the west coast have been noted, and attributed to possible shifts in distribution to deeper offshore waters during late winter, seasonal movement patterns are not fully understood.
The Northern Oregon/Washington Coast Stock of harbor porpoise may be found near the project site. This stock occurs in waters from Lincoln City, Oregon to Cape Flattery Washington. Little information exists on harbor porpoise movements and stock structure in Grays Harbor, although it is suspected that in some areas harbor porpoises migrate (based on seasonal shifts in distribution).
Harbor porpoise primarily frequent coastal waters and occur most frequently in waters less than 328 ft (100 m) deep (Hobbs and Waite 2010). They may occasionally be found in deeper offshore waters. Hall (WSDOT 2018) found that the highest numbers were observed at water depths ranging from 61 to 100 m. Harbor porpoises are most often observed in small groups of one to eight animals (Baird 2003).
Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Current data indicate that not all marine mammal species have equal hearing capabilities (
• Low-frequency cetaceans (mysticetes): Generalized hearing is estimated to occur between approximately 7 Hz and 35 kHz;
• Mid-frequency cetaceans (larger toothed whales, beaked whales, and most delphinids): Generalized hearing is estimated to occur between approximately 150 Hz and 160 kHz;
• High-frequency cetaceans (porpoises, river dolphins, and members of the genera Kogia and Cephalorhynchus; including two members of the genus Lagenorhynchus, on the basis of recent echolocation data and genetic data): Generalized hearing is estimated to occur between approximately 275 Hz and 160 kHz.
• Pinnipeds in water; Phocidae (true seals): Generalized hearing is estimated to occur between approximately 50 Hz to 86 kHz;
• Pinnipeds in water; Otariidae (eared seals): Generalized hearing is estimated to occur between 60 Hz and 39 kHz.
The pinniped functional hearing group was modified from Southall
For more detail concerning these groups and associated frequency ranges, please see NMFS (2018) for a review of available information. Five marine mammal species (2 cetacean and 3 pinniped (2 otariid and 1 phocid) species) have the reasonable potential to co-occur with the proposed survey activities. Please refer to Table 2. Of the cetacean species that may be present, one is classified as a low-frequency cetacean (
This section includes a summary and discussion of the ways that components of the specified activity may impact marine mammals and their habitat. The
The proposed River Bridge-Scour repair project will utilize in-water vibratory pile driving and pile removal that could adversely affect marine mammal species and stocks by exposing them to elevated noise levels in the vicinity of the activity area.
Exposure to high intensity sound for a sufficient duration may result in auditory effects such as a noise-induced threshold shift (TS)—an increase in the auditory threshold after exposure to noise (Finneran
Threshold Shift (noise-induced loss of hearing)—When animals exhibit reduced hearing sensitivity (
For marine mammals, published data are limited to the captive bottlenose dolphin, beluga, harbor porpoise, and Yangtze finless porpoise (Finneran
Lucke
Marine mammal hearing plays a critical role in communication with conspecifics, and interpretation of environmental cues for purposes such as predator avoidance and prey capture. Depending on the degree (elevation of threshold in dB), duration (
Masking—In addition, chronic exposure to excessive, though not high-intensity, noise could cause masking at particular frequencies for marine mammals that utilize sound for vital biological functions (Clark
Masking occurs at the frequency band that the animals utilize. Therefore, since noise generated from vibratory pile driving activity is mostly concentrated at low frequency ranges, it may have less effect on high frequency echolocation sounds by odontocetes (toothed whales). However, lower frequency man-made noises are more likely to affect detection of communication calls and other potentially important natural sounds such as surf and prey noise. It may also affect communication signals when they occur near the noise band and thus reduce the communication space of animals (
Unlike TS, masking, which can occur over large temporal and spatial scales, can potentially affect the species at
Acoustic Effects, Airborne—Pinnipeds that occur near the project site could be exposed to airborne sounds associated with pile driving that have the potential to cause behavioral harassment, depending on their distance from pile driving activities. Cetaceans are not expected to be exposed to airborne sounds that would result in harassment as defined under the MMPA.
Airborne noise will primarily be an issue for pinnipeds that are swimming or hauled out near the project site within the range of noise levels elevated above the acoustic criteria. We recognize that pinnipeds in the water could be exposed to airborne sound that may result in behavioral harassment when looking with their heads above water. Most likely, airborne sound would cause behavioral responses similar to those discussed above in relation to underwater sound. For instance, anthropogenic sound could cause hauled-out pinnipeds to exhibit changes in their normal behavior, such as reduction in vocalizations, or cause them to temporarily abandon the area and move further from the source. However, these animals would previously have been `taken' because of exposure to underwater sound above the behavioral harassment thresholds, which are in all cases larger than those associated with airborne sound. Thus, the behavioral harassment of these animals is already accounted for in these estimates of potential take. Therefore, we do not believe that authorization of incidental take resulting from airborne sound for pinnipeds is warranted, and airborne sound is not discussed further here.
Behavioral disturbance—Finally, marine mammals' exposure to certain sounds could lead to behavioral disturbance (Richardson
The onset of behavioral disturbance from anthropogenic noise depends on both external factors (characteristics of noise sources and their paths) and the receiving animals (hearing, motivation, experience, demography) and is also difficult to predict (Southall
The biological significance of many of these behavioral disturbances is difficult to predict, especially if the detected disturbances appear minor. However, the consequences of behavioral modification could be biologically significant if the change affects growth, survival, and/or reproduction, which depends on the severity, duration, and context of the effects.
Habitat—The primary potential impacts to marine mammal habitat are associated with elevated sound levels produced by pile driving and removal associated with marine mammal prey species. However, other potential impacts to the surrounding habitat from physical disturbance are also possible. Prey species for the various marine mammals include marine invertebrates and fish species. Short-term effects would occur to marine invertebrates during removal of existing piles. This effect is expected to be minor and short-term on the overall population of marine invertebrates in Grays Harbor. Construction will also have temporary effects on salmonids and other fish species in the project area due to disturbance, turbidity, noise, and the potential resuspension of contaminants. All in-water work will occur during the designated in-water work window, to minimize effects on juvenile salmonids.
SPLs from vibratory driving generally do not have the potential to injure or kill fish in the immediate area. Experiments have shown that fish can sense both the strength and direction of sound (Hawkins and Horner 1981). Primary factors determining whether a fish can sense a sound signal, and potentially react to it, are the frequency of the signal and the strength of the signal in relation to the natural background noise level. The level of sound at which a fish will react or alter its behavior is usually well above the detection level. Fish have been found to react to sounds when the sound level increased to about 20 dB above the detection level of 120 dB; however, the response threshold can depend on the time of year and the fish's physiological condition (Engas
There are no critical habitats or other biologically important areas near the proposed project location, although biologically important feeding and migration areas for gray whales have been established along the coast beyond the mouth of Grays Harbor. However, the project site is upriver to the east of the Harbor, so there will be no impacts to these areas. While harbor seals, California sea lions, and other marine mammals may be present, the area is not an established rookery or breeding ground for local populations. Additionally, during construction activity only a small fraction of the available habitat would be ensonified.
Short-term turbidity is a water quality effect of most in-water work, including pile driving. Cetaceans are not expected to be close enough to the Chehalis River Bridge to experience turbidity, and any pinnipeds will be transiting the terminal area and could avoid localized areas of turbidity. Therefore, the impact from increased turbidity levels is expected to be discountable to marine mammals.
For these reasons, any adverse effects to marine mammal habitat in the area from WSDOT's proposed project would be minor.
This section provides an estimate of the number of incidental takes proposed for authorization through this IHA, which will inform both NMFS' consideration of “small numbers” and the negligible impact determination.
Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral
Authorized takes would be by Level B harassment only, in the form of disruption of behavioral patterns for individual marine mammals resulting from exposure to vibratory driving. Based on the nature of the activity and the anticipated effectiveness of the mitigation measures (
As described previously, no mortality is anticipated or proposed to be authorized for this activity. Below we describe how the take is estimated.
Generally speaking, we estimate take by considering: (1) acoustic thresholds above which NMFS believes the best available science indicates marine mammals will be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) and the number of days of activities. We note that while these basic factors can contribute to a basic calculation to provide an initial prediction of takes, additional information that can qualitatively inform take estimates is also sometimes available (
Using the best available science, NMFS has developed acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur PTS of some degree (equated to Level A harassment).
Level B Harassment for non-explosive sources—Though significantly driven by received level, the onset of behavioral disturbance from anthropogenic noise exposure is also informed to varying degrees by other factors related to the source (
WSDOT's proposed activity includes the use of continuous (vibratory driving and removal and, therefore, the 120 dB re 1 μPa (rms) is applicable.
Level A harassment for non-explosive sources—NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (Version 2.0) (NMFS, 2018) identifies dual criteria to assess auditory injury (Level A harassment) to five different marine mammal groups (based on hearing sensitivity) as a result of exposure to noise from two different types of sources (impulsive or non-impulsive). WSDOT's proposed activity includes the use non-impulsive (vibratory driving) sources.
These thresholds are provided in Table 3 below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS 2018 Technical Guidance, which may be accessed at:
Here, we describe operational and environmental parameters of the activity that will feed into identifying the area ensonified above the acoustic thresholds, which include source levels and transmission loss coefficient.
Reference sound source levels used by WSDOT vibratory piling driving and removal activities were derived from several sources. WSDOT utilized in-water measurements generated by the Greenbusch Group (2018) from the WDOT Seattle Pier 62 project (83 FR 39709) to establish proxy sound source levels for vibratory removal of 14-inch timber piles. The results determined unweighted rms ranging from 140 dB to 169 dB. WSDOT used the 75th percentile of these values (161 dB rms measured at 10 meters) as a proxy for vibratory removal of 14-inch timber piles at the Chehalis River Bridge. However, NMFS reviewed the report by the Greenbusch Group (2018) and determined that the findings were derived by pooling together all steel pile and timber pile at various distance measurements data together. The data was not normalized to the standard 10 m distance. NMFS analyzed source measurements at different distances for all 63 individual timber piles that were removed and normalized the values to 10 m. The results showed that the median is 152 dB SPLrms. This value was used as the source level for vibratory removal of 14-inch timber piles.
The proposed project includes vibratory driving of 18 sheet piles as well as vibratory driving and removal of six steel H piles. Based on in-water measurements at the Elliot Bay Seawall Project, vibratory pile driving of steel sheet piles generated a source level of 165 dB rms measured at 10 m (Greenbush Group 2015). According to CalTrans (2015), 150 dB rms at 10 m is a typical source level for vibratory driving and removal of steel H piles.
The practical spreading model was used by WSDOT to establish the Level B harassment zones for all vibratory pile installation and removal activities. Practical spreading is described in full detail below.
Pile driving generates underwater noise that can potentially result in disturbance to marine mammals in the project area. Transmission loss (TL) is the decrease in acoustic intensity as an acoustic pressure wave propagates out from a source. TL parameters vary with frequency, temperature, sea conditions, current, source and receiver depth, water depth, water chemistry, and bottom composition and topography. The general formula for underwater TL is:
This formula neglects loss due to scattering and absorption, which is assumed to be zero here. The degree to which underwater sound propagates away from a sound source is dependent on a variety of factors, most notably the water bathymetry and presence or absence of reflective or absorptive conditions including in-water structures and sediments. Spherical spreading occurs in a perfectly unobstructed (free-field) environment not limited by depth or water surface, resulting in a 6 dB reduction in sound level for each doubling of distance from the source (20 * log[range]). Cylindrical spreading occurs in an environment in which sound propagation is bounded by the water surface and sea bottom, resulting in a reduction of 3 dB in sound level for each doubling of distance from the source (10 * log[range]). A practical spreading value of 15 is often used under conditions where water increases with depth as the receiver moves away from the shoreline, resulting in an expected propagation environment that would lie between spherical and cylindrical spreading loss conditions.
Utilizing the practical spreading loss model, WSDOT determined the distance and area where the noise will fall below the behavioral effects threshold of 120 dB rms. The distances and areas are shown in Table 4. Note that the ensonified area is based on a GIS analysis of the area accounting for structures and landmasses which would block underwater sound transmission.
When the NMFS Technical Guidance (2016) was published, in recognition of the fact that ensonified area/volume could be more technically challenging to predict because of the duration component in the new thresholds, we developed a User Spreadsheet that includes tools to help predict a simple isopleth that can be used in conjunction with marine mammal density or occurrence to help predict takes. We note that because of some of the assumptions included in the methods used for these tools, we anticipate that isopleths produced are typically going to be overestimates of some degree. However, these tools offer the best way to predict appropriate isopleths when more sophisticated 3D modeling methods are not available, and NMFS continues to develop ways to quantitatively refine these tools, and will qualitatively address the output where appropriate. For stationary sources such as vibratory driving, NMFS User Spreadsheet predicts the closest distance at which, if a marine mammal remained at that distance the whole duration of the activity, it would not incur PTS. User Spreadsheet inputs are shown in Table 5 and outputs are shown in Table 6. Note that since no Level A harassment take is proposed, the areas of Level A harassment zones were not calculated.
In this section we provide the information about the presence, density, or group dynamics of marine mammals that will inform the take calculations.
There is little abundance or density data available for marine mammal species that are likely to occur within Grays Harbor and which could potentially be found in the Chehalis River near the project site. In most cases, WSDOT relied on density data from the U.S. Navy Marine Species Density Database (NMSDD) (U.S. Navy 2015). NMFS concurs that this, and the exceptions described below, represent the best available data for use here.
While the NMSDD (U.S. Navy 2015) estimates the density of harbor seals in the waters offshore of Grays Harbor as 0.279 animals per square kilometer, WSDOT relied on a study which identified 44 harbor seal haul outs in Grays Harbor and provided very rough estimates of the number of seals at each site. Twenty-seven haul outs had less than 100 animals; 16 haul outs had 100-500 animals; and two haul outs were reported to support over 500 animals (Jeffries
Only 10 California sea lion strandings have been documented between 2006 and 2015 (NMFS 2016c), and no haul outs have been identified. Therefore, it is expected that the density of California sea lions in Grays Harbor is low. The NMSDD (U.S. Navy 2015) estimates the density of California sea lions in the waters offshore of Grays Harbor as ranging from 0.020 to 0.033 animals per square kilometer in summer and fall. The higher estimate is used as a surrogate for Grays Harbor.
According to the NMFS National Stranding Database, there were four confirmed Steller sea lion strandings in Grays Harbor between 2006 and 2015 (NMFS 2016c) and no haul outs have been identified in Grays Harbor. The NMSDD (U.S. Navy 2015) estimates the density of Steller sea lions in the waters offshore of Grays Harbor as 0.0145 animals per square kilometer. This estimate is used as a surrogate for Grays Harbor.
Between 1998 and 2010, gray whale numbers peaked in spring and fall in a study area that included waters inside Grays Harbor and coastal waters along the south Washington coast (Calambokidis,
The NMSDD (U.S. Navy 2015) estimates the density of harbor porpoises in the waters offshore of Grays Harbor as a range between 0.69 and 1.67 animals per square kilometer. According to Evenson
Here we describe how the information provided above is brought together to produce a quantitative take estimate.
No Level A harassment take is likely because of the small injury zones and relatively low average animal density in the area. Since the largest Level A harassment distance is only 50.9 m from the source for high-frequency cetaceans (harbor porpoise), NMFS considers that WSDOT can effectively monitor such small zones to implement shutdown measures and avoid Level A harassment takes. Therefore, no Level A harassment take of marine mammal is proposed or authorized.
NMFS used an estimated harbor seal density of 29.4 animals/km
• 14-inch timber pile removal: 29.4. animals/km
• Sheet pile installation: 29.4 animals/km
Based on the sum of the equations above, NMFS proposes to authorize 214 takes of harbor seals by Level B harassment.
NMFS inserted the California sea lion density of 0.033 animals/km
NMFS estimated take of Steller sea lions by inserting a density of 0.0145 animals/km
NMFS used the same equation that was used for harbor seals to estimate take for gray whales by inserting a density value of 0.00045 animals/km
A density value of 1.67 animal/km
Table 7 shows total number of authorized Level B harassment takes and take as a percentage of population for each of the species.
In order to issue an IHA under Section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (latter not applicable for this action). NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting such activity or other means of effecting the least practicable adverse impact upon the affected species or stocks and their habitat (50 CFR 216.104(a)(11)).
In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, we carefully consider two primary factors:
(1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat. This considers the nature of the potential adverse impact being mitigated (likelihood, scope, range). It further considers the likelihood that the measure will be effective if implemented (probability of accomplishing the mitigating result if implemented as planned) the likelihood of effective implementation (probability implemented as planned), and;
(2) the practicability of the measures for applicant implementation, which may consider such things as cost, impact on operations, and, in the case of a military readiness activity, personnel safety, practicality of implementation, and impact on the effectiveness of the military readiness activity.
Temporal and Seasonal Restrictions—Timing restrictions would be used to avoid in-water work when ESA-listed salmonids are most likely to be present. The combined work window for in-water work for the U.S. 101/Chehalis River Bridge -Scour Project is July 15 through February 15. Furthermore, work may only occur during daylight hours, when visual monitoring of marine mammals can be effectively conducted.
Establishment of Shutdown Zone—For all pile driving activities, WSDOT will establish a shutdown zone. The purpose of a shutdown zone is generally to define an area within which shutdown of activity would occur upon sighting of a marine mammal (or in anticipation of an animal entering the defined area). In this case, shutdown zones are intended to contain areas in which sound pressure levels (SPLs) equal or exceed acoustic injury criteria for authorized species. If a marine mammal is observed at or within the shutdown zone, work must shut down (stop work) until the individual has been observed outside of the zone, or has not been observed for at least 15 minutes for all marine mammals. A determination that the shutdown zone is clear must be made during a period of good visibility (
For in-water heavy machinery activities other than pile driving, if a marine mammal comes within 10 m, operations must cease and vessels must reduce speed to the minimum level required to maintain steerage and safe working conditions. WSDOT must also implement shutdown measures if the cumulative total number of individuals observed within the Level B harassment monitoring zones for any particular species reaches the number authorized under the IHA and if such marine mammals are sighted within the vicinity of the project area and are approaching the Level B Harassment/Monitoring Zone during in-water construction activities.
Establishment of Level B Harassment/Monitoring Zones—WSDOT must identify and establish Level B harassment zones which are areas where SPLs equal or exceed 120 dB rms. Observation of monitoring zones enables observers to be aware of and communicate the presence of marine mammals in the project area and outside the shutdown zone and thus prepare for potential shutdowns of activity. Monitoring zones are also used to document instances of Level B harassment. Monitoring zone isopleths are shown in Table 4.
Pre-Activity Monitoring—Prior to the start of daily in-water construction activity, or whenever a break in pile driving of 30 minutes or longer occurs, the observer shall observe the shutdown and monitoring zones for a period of 30 minutes. The shutdown zone shall be cleared when a marine mammal has not been observed within the zone for that 30-minute period. When a marine mammal permitted for Level B harassment take is present in the Level B harassment zone, piling activities may begin and Level B harassment take shall be recorded. As stated above, if the entire Level B harassment zone is not visible at the start of construction, piling driving activities can begin. If work ceases for more than 30 minutes, the pre-activity monitoring of both the Level B harassment and shutdown zone shall commence.
Based on our evaluation of the applicant's proposed measures, NMFS has preliminarily determined that the proposed mitigation measures provide the means effecting the least practicable impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance
In order to issue an IHA for an activity, Section 101(a)(5)(D) of the MMPA states that NMFS must set forth, requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. Effective reporting is critical both to compliance as well as ensuring that the most value is obtained from the required monitoring.
Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:
• Occurrence of marine mammal species or stocks in the area in which take is anticipated (
• Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (
• Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;
• How anticipated responses to stressors impact either: (1) Long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks;
• Effects on marine mammal habitat (
• Mitigation and monitoring effectiveness.
WSDOT shall employ NMFS-approved protected species observers (PSOs) to conduct marine mammal monitoring for its US 101/Chehalis River Bridge-Scour Repair Project. The purposes of marine mammal monitoring are to implement mitigation measures and learn more about impacts to marine mammals from WSDOT's construction activities. The PSOs will observe and collect data on marine mammals in and around the project area for 30 minutes before, during, and for 30 minutes after all pile removal and pile installation work. NMFS-approved PSOs shall meet the following requirements:
1. Independent observers (
2. At least one observer must have prior experience working as an observer;
3. Other observers may substitute education (undergraduate degree in biological science or related field) or training for experience;
4. Where a team of three or more observers are required, one observer
5. NMFS will require submission and approval of observer CVs.
WSDOT must ensure that observers have the following additional qualifications:
1. Ability to conduct field observations and collect data according to assigned protocols;
2. Experience or training in the field identification of marine mammals, including the identification of behaviors;
3. Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;
4. Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates, times, and reason for implementation of mitigation (or why mitigation was not implemented when required); and marine mammal behavior; and
5. Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.
Monitoring of marine mammals around the construction site shall be conducted using high-quality binoculars (
For vibratory pile driving and pile removal of sheet piles, a total of four land-based PSOs will monitor the shutdown and Level B harassment zones. For vibratory pile driving and pile removal of H piles and timber piles, a total of three land-based PSOs will monitor the shutdown and Level B harassment zones.
WSDOT is required to submit a draft monitoring report within 90 days after completion of the construction work or the expiration of the IHA (if issued), whichever comes earlier. This report would detail the monitoring protocol, summarize the data recorded during monitoring, and estimate the number of marine mammals that may have been harassed. NMFS would have an opportunity to provide comments on the report, and if NMFS has comments, WSDOT would address the comments and submit a final report to NMFS within 30 days. Reports shall contain, at minimum, the following:
• Date and time that monitored activity begins and ends for each day conducted (monitoring period);
• Construction activities occurring during each daily observation period, including how many and what type of piles driven;
• Deviation from initial proposal in pile numbers, pile types, average driving times, etc.
• Weather parameters in each monitoring period (
• Water conditions in each monitoring period (
• For each marine mammal sighting:
○ Species, numbers, and, if possible, sex and age class of marine mammals;
○ Description of any observable marine mammal behavior patterns, including bearing and direction of travel and distance from pile driving activity;
○ Location and distance from pile driving activities to marine mammals and distance from the marine mammals to the observation point;
○ Estimated amount of time that the animals remained in the Level B harassment zone
• Description of implementation of mitigation measures within each monitoring period (
• Other human activity in the area within each monitoring period;
• A summary of the following:
○ Total number of individuals of each species detected within the Level B harassment zone;
○ Total number of individuals of each species detected within the shutdown zone and the average amount of time that they remained in that zone; and
○ Daily average number of individuals of each species (differentiated by month as appropriate) detected within the Level B harassment zone.
NMFS has defined negligible impact as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
NMFS has identified key qualitative and quantitative factors which may be employed to assess the level of analysis necessary to conclude whether potential impacts associated with a specified activity should be considered negligible. These include (but are not limited to) the type and magnitude of taking, the amount and importance of the available habitat for the species or stock that is affected, the duration of the anticipated effect to the species or stock, and the status of the species or stock. When an evaluation of key factors shows that the anticipated impacts of the specified activity would clearly result in no greater than a negligieble impact on all affected species or stocks, additional evaluation is not required. In this case, the following factors are in place for all affected species or stocks:
• No takes by Level A harassment are anticipated or authorized;
• Takes by Level B harassment constitute less than 5% of the best available abundance estimates for all stocks;
• Take would not occur in places and/or times where take would be more likely to accrue to impacts on reproduction or survival, such as within ESA-designated or proposed critical habitat, biologically important areas (BIA), or other habitats critical to recruitment or survival (
• Take would occur over a short timeframe (less than 30 days of active pile driving required during the IHA effective period);
• Take would occur over <25% of species/stock range; and
• Stock is not known to be declining or suffering from known contributors to
Based on these factors, and taking into consideration the implementation of the prescribed monitoring and mitigation measures, NMFS preliminarily finds that the total take from the proposed activity will have a negligible impact on all affected marine mammal species or stocks.
As noted above, only small numbers of incidental take may be authorized under Sections 101(a)(5)(A) and (D) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.
NMFS has estimated that take for all species authorized is less than two percent of their respective stock abundance (Table 7). Based on the analysis contained herein of the proposed activity (including the proposed mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS preliminarily finds that small numbers of marine mammals will be taken relative to the population size of the affected species or stocks.
There are no relevant subsistence uses of the affected marine mammal stocks or species implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.
No incidental take of ESA-listed species is proposed for authorization or expected to result from this activity. Therefore, NMFS has determined that formal consultation under section 7 of the ESA is not required for this action.
As a result of these preliminary determinations, NMFS proposes to issue an IHA to WSDOT for conducting US 101/Chehalis River Bridge-Scour Repair Project between July 15, 2019, and February 15, 2020, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated. This section contains a draft of the IHA itself. The wording contained in this section is proposed for inclusion in the IHA (if issued).
1. This Authorization is valid from July 15, 2019, through February 15, 2020.
2. This Authorization is valid only for activities associated with in-water construction work at the US 101/Chehalis River Bridge-Scour Repair Project in the State of Washington.
3. General Conditions.
(a) A copy of this IHA must be in the possession of WSDOT, its designees, and work crew personnel operating under the authority of this IHA.
(b) The species and number of authorized Level B harassment takes are provided in Table 7.
(c) The taking by serious injury or death of any of the species listed in condition 3(b), or any taking of any other species of marine mammal not listed in condition 3(b) of the Authorization is prohibited and may result in the modification, suspension, or revocation of this IHA.
(d) WSDOT must conduct briefings between construction supervisors and crews, marine mammal monitoring team, and WSDOT staff prior to the start of all pile driving, and when new personnel join the work, in order to explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures.
4. Mitigation Measures.
The holder of this Authorization is required to implement the following mitigation measures:
(a) In-water construction work must occur only during daylight hours.
(b) For in-water heavy machinery activities other than pile driving, if a marine mammal comes within 10 meters (m), operations must cease and vessels must reduce speed to the minimum level required to maintain steerage and safe working conditions.
(c) Pre-activity marine mammal monitoring must take place from 30 minutes prior to initiation of pile driving and removal. Post-activity marine mammal monitoring must continue through 30 minutes post-completion of pile driving and removal. Pile driving and removal may commence at the end of the 30-minute pre-activity monitoring period, provided observers have determined that the relevant shutdown zone (Table 8) is clear of marine mammals.
(d) WSDOT must establish and monitor shutdown zone and Level B harassment zones:
i. Shutdown zone sizes for various pile driving activities and marine mammal hearing groups are shown in Table 8.
ii. Level B harassment zone sizes are shown in Table 3.
(e) If a marine mammal approaches or enters the shutdown zone (Table 8) during activities or pre-activity monitoring, all pile driving activities at that location must be halted or delayed, respectively. If pile driving is halted or delayed due to the presence of a marine mammal, the activity may not resume or commence until either the animal has voluntarily left and been visually confirmed beyond the shutdown zone or 15 minutes have passed without re-detection of the animal. Pile driving activities include the time to install or remove a single pile or series of piles, as long as the time elapsed between uses of the pile driving equipment is no more than thirty minutes.
(f) WSDOT must establish monitoring locations and protocols as described below. Please also refer to the Marine Species Monitoring Plan (Monitoring Plan; attached).
i. For vibratory pile driving of sheet piles, a total of four land-based PSOs must monitor the shutdown zone and Level B harassment zone as depicted in the Monitoring Plan.
ii. For vibratory pile removal of timber piles and vibratory installation and removal of H piles, a total of three land-based PSOs must monitor the shutdown and Level B harassment zones.
5. Monitoring.
The holder of this Authorization is required to conduct marine mammal monitoring during pile driving and removal.
(a) Monitoring during pile driving and removal must be conducted by NMFS-approved PSOs in a manner consistent with the following:
i. Independent PSOs (
ii. At least one PSO must have prior experience working as a marine mammal observer during construction activities. Other PSOs may substitute education (degree in biological science or related field) or training for experience.
iii. Where a team of three or more PSOs are required, a lead observer or monitoring coordinator must be designated. The lead observer must have prior experience working as a marine mammal observer during construction.
iv. WSDOT must submit PSO CVs for approval by NMFS prior to the onset of pile driving.
v. WSDOT must ensure that observers have the following additional qualifications:
a. Ability to conduct field observations and collect data according to assigned protocols.
b. Experience or training in the field identification of marine mammals, including the identification of behaviors.
c. Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations.
d. Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates, times, and reason for implementation of mitigation (or why mitigation was not implemented when required); and marine mammal behavior.
e. Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.
6. Reporting.
The holder of this Authorization is required to submit marine mammal monitoring and acoustic reports:
(a) WSDOT must submit a draft report on all marine mammal monitoring conducted under this Authorization within ninety calendar days following the completion of monitoring. A final report must be submitted within thirty days following resolution of comments on the draft report from NMFS. The marine mammal monitoring report must contain, at minimum, the informational elements described below:
i. Date and time that monitored activity begins and ends for each day conducted (monitoring period);
ii. Construction activities occurring during each daily observation period, including how many and what type of piles driven;
iii. Deviation from initial proposal in pile numbers, pile types, average driving times, etc.
iv. Weather parameters in each monitoring period (
v. Water conditions in each monitoring period (
vi. For each marine mammal sighting:
a. Species, numbers, and, if possible, sex and age class of marine mammals;
b. Description of any observable marine mammal behavior patterns, including bearing and direction of travel and distance from pile driving activity;
c. Location and distance from pile driving activities to marine mammals and distance from the marine mammals to the observation point;
d. Estimated amount of time that the animals remained in the Level B harassment zone;
vii. Description of implementation of mitigation measures within each monitoring period (
viii. Other human activity in the area within each monitoring period
ix. A summary of the following:
a. Total number of individuals of each species detected within the Level B harassment zone.
b. Total number of individuals of each species detected within the Level A harassment zone and the average amount of time that they remained in that zone.
c. Daily average number of individuals of each species (differentiated by month as appropriate) detected within the Level B Zone, and estimated as taken, if appropriate.
(b) Reporting injured or dead marine mammals:
i. In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by this IHA, such as serious injury, or mortality, WSDOT must immediately cease the specified activities and report the incident to the Office of Protected Resources, NMFS, and the West Coast Region Stranding Coordinator, NMFS. The report must include the following information:
1. Time and date of the incident;
2. Description of the incident;
3. Environmental conditions (
4. Description of all marine mammal observations and active sound source use in the 24 hours preceding the incident;
5. Species identification or description of the animal(s) involved;
6. Fate of the animal(s); and
7. Photographs or video footage of the animal(s).
Activities must not resume until NMFS is able to review the circumstances of the prohibited take. NMFS will work with WSDOT to determine what measures are necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. WSDOT may not resume their activities until notified by NMFS.
ii. In the event WSDOT discovers an injured or dead marine mammal, and the lead observer determines that the cause of the injury or death is unknown and the death is relatively recent (
iii. In the event that WSDOT discovers an injured or dead marine mammal, and the lead observer determines that the injury or death is not associated with or related to the activities authorized in the IHA (
7. This Authorization may be modified, suspended or withdrawn if the holder fails to abide by the conditions prescribed herein, or if NMFS determines the authorized taking is having more than a negligible impact on the species or stock of affected marine mammals.
We request comment on our analyses, the proposed authorization, and any other aspect of this Notice of Proposed IHA for the proposed project. We also request comment on the potential for renewal of this proposed IHA as described in the paragraph below. Please include with your comments any supporting data or literature citations to help inform our final decision on the request for MMPA authorization.
On a case-by-case basis, NMFS may issue a second one-year IHA without additional notice when (1) another year of identical or nearly identical activities as described in the Specified Activities section is planned or (2) the activities would not be completed by the time the IHA expires and a second IHA would allow for completion of the activities beyond that described in the Dates and Duration section, provided all of the following conditions are met:
• A request for renewal is received no later than 60 days prior to expiration of the current IHA;
• The request for renewal must include the following:
(1) An explanation that the activities to be conducted beyond the initial dates either are identical to the previously analyzed activities or include changes so minor (
(2) A preliminary monitoring report showing the results of the required monitoring to date and an explanation showing that the monitoring results do not indicate impacts of a scale or nature not previously analyzed or authorized;
• Upon review of the request for renewal, the status of the affected species or stocks, and any other pertinent information, NMFS determines that there are no more than minor changes in the activities, the mitigation and monitoring measures remain the same and appropriate, and the original findings remain valid.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of intent to prepare a Draft Supplemental Environmental Impact Statement.
Pursuant to the National Environmental Policy Act (NEPA), this notice announces that NMFS is preparing a Draft Supplemental Environmental Impact Statement (DSEIS) to supplement information in the 2017 Draft Environmental Impact Statement (DEIS) for 10 Hatchery and Genetic Management Plans (HGMP) for salmon and steelhead hatchery programs jointly submitted by the Washington Department of Fish and Wildlife (WDFW) with the Muckleshoot Indian Tribe and the Suquamish Tribe (referred to as the co-managers), for NMFS's evaluation and determination under Limit 6 of the Endangered Species Act (ESA) 4(d) Rule for threatened salmon and steelhead. The HGMPs specify the propagation of salmon and steelhead in the Duwamish-Green River basin in Washington State. The DSEIS will analyze an additional alternative reflecting an increase in hatchery production of juvenile Chinook salmon.
Because NMFS has previously requested (81 FR 26776, May 6, 2016) and received information from the public on issues to be addressed in the EIS, and because the Council on Environmental Quality (CEQ) regulations for implementing the National Environmental Policy Act (NEPA) do not require additional scoping for this DSEIS process (40 CFR 1502.9(c)(4)), NMFS is not asking for further public scoping information and comment at this time. Upon release of the DSEIS, NMFS will provide a 45-day public review/comment period.
Copies of the 2017 DEIS are available from NMFS, Sustainable Fisheries Division at 510 Desmond Drive SE, Suite 103, Lacey, WA 98503, and on the web at
Steve Leider, NMFS, by phone at (360) 753-4650, or email to
The WDFW, and the co-managers have jointly submitted to NMFS HGMPs for 10 hatchery programs in the Duwamish-Green River basin in Washington State. The HGMPs reviewed in the DEIS were submitted to NMFS from 2013 to 2015, pursuant to limit 6 of the 4(d) Rule for salmon and steelhead. The hatchery programs include releases of ESA-listed Chinook salmon and winter-run steelhead into the Duwamish-Green River basin. The hatchery programs also release non-listed coho and fall-run chum salmon and summer-run steelhead into the Duwamish-Green River basin. One hatchery program releases coho salmon into marine waters adjacent to the Duwamish-Green River basin. Seven of the programs are currently operating, and three are new.
NEPA requires Federal agencies to conduct environmental analyses of their proposed major actions to determine if the actions may affect the human environment. NMFS's action of determining that implementation of the co-managers' HGMPs would not appreciably reduce the likelihood of survival and recovery of affected threated ESUs under Limit 6 of the 4(d) Rule for salmon and steelhead promulgated under the ESA, is a major Federal action subject to environmental review under NEPA.
On May 4, 2016, NMFS announced its intent to prepare an EIS and the 30-day public scoping period ended on June 3, 2016. On November 3, 2017, NMFS announced the release of a DEIS for public comment. The DEIS includes an analysis of the proposed action identified in the 2016 NOI and the anticipated environmental impacts. Following an extension, the 75-day public comment period ended on January 19, 2018.
In light of subsequent information, NMFS has determined that the Final EIS would benefit from the analysis of an expanded range of potential alternatives for hatchery production of Chinook salmon. The alternative to be analyzed in the DSEIS is informed by the applicant's interest in increasing hatchery production of juvenile Chinook salmon, and NMFS' analysis of the status of endangered Southern Resident Killer Whales and the importance of Chinook salmon prey to their food base. The DSEIS will analyze an increased level of Chinook salmon hatchery production and provide the public with an opportunity for review and comment. The DSEIS, in conjunction with the 2017 DEIS, will collectively evaluate the proposed action and alternatives.
The alternatives analyzed in the 2017 DEIS are summarized in the DEIS Notice of Intent (82 FR 26776, May 4, 2016). The upcoming DSEIS will analyze an alternative in which hatchery production from the Soos Creek Chinook salmon program would produce an additional 2,000,000 juvenile Chinook salmon to be released at Palmer Ponds in the Duwamish-Green River basin.
The environmental review of the 10 salmon and steelhead HGMPs in the Duwamish-Green River basin of Washington State will be conducted in accordance with requirements of the NEPA of 1969 as amended (42 U.S.C. 4321
Committee for Purchase From People Who Are Blind or Severely Disabled.
Deletions from the Procurement List.
This action deletes a product and services from the Procurement List previously furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.
Michael R. Jurkowski, Telephone: (703) 603-2117, Fax: (703) 603-0655, or email
On 9/14/2018 (83 FR 179), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List.
After consideration of the relevant matter presented, the Committee has determined that the product and services listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. The action may result in authorizing small entities to furnish the product and services to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the product and services deleted from the Procurement List.
Accordingly, the following product and services are deleted from the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed addition to and deletions from the Procurement List.
The Committee is proposing to add a service to the Procurement List that will be provided by a nonprofit agency employing persons who are blind or have other severe disabilities, and deletes products previously furnished by such agencies.
Comments must be received on or before: November 18, 2018.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S Clark Street, Suite 715, Arlington, Virginia 22202-4149.
For further information or to submit comments contact: Michael R. Jurkowski, Telephone: (703) 603-2117, Fax: (703) 603-0655, or email
This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
If the Committee approves the proposed addition, the entities of the Federal Government identified in this notice will be required to provide the service listed below from a nonprofit agency employing persons who are blind or have other severe disabilities.
The following service is proposed for addition to the Procurement List for production by the nonprofit agency listed:
The following products are proposed for deletion from the Procurement List:
Office of Postsecondary Education (OPE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Interested persons are invited to submit comments on or before December 18, 2018.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Herman Bounds, 202-453-6128.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This is a supplemental notice in the above-referenced proceeding of Luminant Energy Company LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 5, 2018.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380, the Office of Energy Projects has reviewed the original license application for the Fresno Dam Site Water Power Project, located on the Milk River, at the existing U.S. Bureau of Reclamation's (Reclamation) Fresno Dam, in Hill County, Montana, and has prepared an Environmental Assessment (EA) for the project. The project would occupy 0.07 acre of federal land managed by Reclamation.
The EA contains staff's analysis of the potential environmental impacts of the project and concludes that licensing the project, with appropriate environmental protective measures, would not constitute a major federal action that would significantly affect the quality of the human environment.
A copy of the EA is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at
You may also register online at
Any comments should be filed within 30 days from the date of this notice.
The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at
For further information, please contact John Matkowski at (202) 502-8576 or by email at
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at:
Environmental Protection Agency (EPA).
Notice.
In accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is issuing a notice of receipt of requests by registrants through Pesticide Registration Maintenance Fee responses to voluntarily cancel certain pesticide registrations. EPA intends to grant these requests at the close of the comment period for this announcement unless the Agency receives substantive comments within the comment period that would merit its further review of the requests, or unless the registrants withdraw its requests. If these requests are granted, any sale, distribution, or use of products listed in this notice will be permitted after the registrations have been cancelled only if such sale, distribution, or use is consistent with the terms as described in the final order.
Comments must be received on or before November 19, 2018.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2018-0657, by one of the following methods:
•
•
Submit written withdrawal request by mail to: Information Technology and Resources Management Division (7502P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. ATTN: Michael Yanchulis.
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
Michael Yanchulis, Information Technology and Resources Managements Division (7502P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (703) 347-0237; email address:
This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides.
B. What should I consider as I prepare my comments for EPA?
1.
2.
This notice announces receipt by the Agency of requests from registrants to cancel 200 pesticide products registered under FIFRA section 3 (7 U.S.C. 136a) or 24(c) (7 U.S.C. 136v(c)). These registrations are listed in sequence by registration number (or company number and 24(c) number) in Table 1 of this unit.
Unless the Agency determines that there are substantive comments that warrant further review of the requests or the registrants withdraw their requests, EPA intends to issue an order in the
Table 2 of this unit includes the names and addresses of record for all registrants of the products in Table 1 of this unit, in sequence by EPA company number. This number corresponds to the first part of the EPA registration numbers of the products listed in this unit.
Section 6(f)(1) of FIFRA (7 U.S.C. 136d(f)(1)) provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the
Registrants who choose to withdraw a request for cancellation should submit such withdrawal in writing to the person listed under
Existing stocks are those stocks of registered pesticide products that are currently in the United States and that were packaged, labeled, and released for shipment prior to the effective date of the cancellation action. Because the Agency has identified no significant potential risk concerns associated with these pesticide products, upon cancellation of the products identified in Table 1 of Unit II., EPA anticipates allowing registrants to sell and distribute existing stocks of these products until January 15, 2019, or the date of that the cancellation notice is published in the
7 U.S.C. 136
Environmental Protection Agency (EPA).
Notice.
This notice announces EPA's approval of the State of Georgia's request to revise its National Primary Drinking Water Regulations Implementation EPA-authorized program to allow electronic reporting.
EPA approves the authorized program revision for the State of Georgia's National Primary Drinking Water Regulations Implementation as of November 19, 2018, if no timely request for a public hearing is received and accepted by the Agency.
Devon Martin, U.S. Environmental Protection Agency, Office of Environmental Information, Mail Stop 2824T, 1200 Pennsylvania Avenue NW, Washington, DC 20460, (202) 566-2603,
On October 13, 2005, the final Cross-Media Electronic Reporting Rule (CROMERR) was published in the
On August 8, 2018, the Georgia Department of Natural Resources (GA DNR) submitted an application titled “Electronic Sample Entry Verify” for revision to its EPA-approved drinking water program under title 40 CFR to allow new electronic reporting. EPA reviewed GA DNR's request to revise its EPA-authorized program and, based on this review, EPA determined that the application met the standards for approval of authorized program revision set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve Georgia's request to revise its Part 142—National Primary Drinking Water Regulations Implementation program to allow electronic reporting under 40 CFR part 141 is being published in the
GA DNR was notified of EPA's determination to approve its application with respect to the authorized program listed above.
Also, in today's notice, EPA is informing interested persons that they may request a public hearing on EPA's action to approve the State of Georgia's request to revise its authorized National Primary Drinking Water Regulations Implementation program under 40 CFR part 142, in accordance with 40 CFR 3.1000(f), to allow for electronic reporting. Requests for a hearing must be submitted to EPA within 30 days of publication of today's
(1) The name, address and telephone number of the individual, organization or other entity requesting a hearing;
(2) A brief statement of the requesting person's interest in EPA's determination, a brief explanation as to why EPA should hold a hearing, and any other information that the requesting person wants EPA to consider when determining whether to grant the request;
(3) The signature of the individual making the request, or, if the request is made on behalf of an organization or other entity, the signature of a responsible official of the organization or other entity.
In the event a hearing is requested and granted, EPA will provide notice of the hearing in the
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “Fuel Use Requirements for Great Lakes Steamships” (EPA ICR No. 2458.03, OMB Control No. 2060-0679) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through October 31, 2018. Public comments were previously requested via the
Additional comments may be submitted on or before November 19, 2018.
Submit your comments, referencing Docket ID Number EPA-HQ-OAR-2011-0928, to (1) EPA online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Alan Stout, Office of Transportation and Air Quality, Environmental Protection Agency, 2565 Plymouth Road, Ann Arbor, MI 48105; 734-214-4805;
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Facility Ground-Water Monitoring Requirements (EPA ICR Number 0959.16, OMB Control Number 2050-0033), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through October 31, 2018. Public comments were previously requested via the
Additional comments may be submitted on or before November 19, 2018.
Submit your comments, referencing Docket ID No. EPA-HQ-OLEM-2018-0391, to (1) EPA, either online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Peggy Vyas, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 703-308-5477; fax number: 703-308-8433; email address:
Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at
This ICR examines the ground-water monitoring standards for permitted and interim status facilities at 40 CFR parts 264 and 265, as specified. The ground-water monitoring requirements for regulated units follow a tiered approach whereby releases of hazardous contaminants are first detected (detection monitoring), then confirmed (compliance monitoring), and if necessary, are required to be cleaned up (corrective action). Each of these tiers requires collection and analysis of ground-water samples. Owners or operators that conduct ground-water monitoring are required to report information to the oversight agencies on releases of contaminants and to maintain records of ground-water monitoring data at their facilities. The goal of the ground-water monitoring program is to prevent and quickly detect releases of hazardous contaminants to groundwater, and to establish a program whereby any contamination is expeditiously cleaned up as necessary to protect human health and environment.
The liquidation of the assets for the receivership has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.
Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing, identify the receivership to which the comment pertains, and sent within thirty days of the date of this notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201.
No comments concerning the termination of this receivership will be considered which are not sent within this time frame.
The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on the agreements to the Secretary by email at
Administration for Community Living, HHS.
Notice.
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the
This proposed Extension with Changes of a Currently Approved Collection (ICR Rev) solicits comments on the information collection requirements relating to the Independent Living Services (ILS) program under the Rehabilitation Act of 1973, 29 U.S.C. 701,
Comments on the information collection request must be submitted electronically by 11:59 p.m. (EST) or postmarked by December 18, 2018.
Submit electronic comments on the information collection request to: Peter Nye at
Peter Nye, Administration for Community Living, Washington, DC 20201, (202) 795-7606 or
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
With respect to the following collection of information, ACL invites comments on our burden estimates or any other aspect of this collection of information, including:
(1) Whether the proposed collection of information is necessary for the proper performance of ACL's functions, including whether the information will have practical utility;
(2) the accuracy of ACL's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used to determine burden estimates;
(3) ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques when appropriate, and other forms of information technology.
In the context of ACL, IL programs are supported through funding authorized by the Rehabilitation Act of 1973, as amended (The Act). Title VII, chapter 1 of the Act states the current purpose of the program is to “promote a philosophy of independent living including a philosophy of consumer control, peer support, self-help, self-determination, equal access, and individual and system advocacy, in order to maximize the leadership, empowerment, independence, and productivity of individuals with disabilities, and the integration and full inclusion of individuals with disabilities into the mainstream of American society.”
The ILS program provides financial assistance, through formula grants, to states, the District of Columbia, Puerto Rico, and outlying areas for providing, expanding, and improving the provision of IL services. The Designated State Entity (DSE) is the agency that, on behalf of the state, receives, accounts for, and disburses funds received under Subchapter B of the Act. Funds are also made available for the provisions of training and technical assistance to SILCs.
The Act of 1973 requires three IL program reports: (1) State Plan for Independent Living, (2) ILS PPR, and (3) Centers for Independent Living PPR. The ILS PPR and CIL PPR were previously combined into one submission. However, for the purposes of this data collection, the ILS PPR and CIL PPR are being submitted separately because they are separate collections of different information from different parties. Separating these PRA processes reduces confusion and increases the Independent Living Administration's ability to identify issues specific to DSEs and SILCs. This request is for the ILS PPR, which is submitted annually by the Statewide Independent Living Council and DSE in every state that receives Subchapter B funds. The ILS PPRs are used by ACL to assess grantees' compliance with title VII of the Act, with 45 CFR part 1329 of the Code of Federal Regulations, and with applicable provisions of the HHS Regulations at 45 CFR part 75. The ILS PPR serves as the primary basis for ACL's monitoring activities in fulfillment of its responsibilities under sections 706 and 722 of the Act. The PPR is also used by ACL to design CIL and SILC training and technical assistance programs authorized by section 721 of the Act.
The current version of the ILS PPR that ILA is requesting an extension for was approved by OMB, but will expire on December 31, 2018. ILA plans to
The proposed data collection tools may be found on the ACL website for review at
ACL estimates the burden of this collection of information as follows: Fifty-six jurisdictions—specifically, the fifty states, Puerto Rico, the District of Columbia, and the outlying areas—will each complete ILS PPRs annually, and it will take an estimated 35 hours per jurisdiction per ILS PPR. The 56 jurisdictions combined will take an estimated 1,960 hours per year to complete ILS PPRs. This burden estimate is based on what DSEs and SILCs have told ILA about how long filling out ILS PPRs took in previous reporting years.
Administration for Community Living, HHS.
Notice.
The Administration for Community Living is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the
This Extension Without Changes (Information Collection Request Ext) solicits comments on the information collection requirements related to the State Plan for Independent Living (SPIL) required under the Rehabilitation Act of 1973, as amended. The Independent Living Administration within ACL is proposing to extend the currently approved forms for one year while we work on a revision. However, we expect to complete the redesign of the proposed information collection forms well before the expiration of the extension.
Comments on the collection of information must be submitted electronically by 11:59 p.m. (EST) or postmarked by December 18, 2018.
Submit electronic comments on the collection of information to: Peter Nye at
Peter Nye, Administration for Community Living, Washington, DC 20201, (202) 795-7606, or
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
With respect to the following collection of information, ACL invites comments on our burden estimates or any other aspect of this collection of information, including:
(1) Whether the proposed collection of information is necessary for the proper performance of ACL's functions, including whether the information will have practical utility;
(2) the accuracy of ACL's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used to determine burden estimates;
(3) ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques when appropriate, and other forms of information technology.
Legal authority for the State Plan for Independent Living is contained in Chapter 1 of Title VII of the Rehabilitation Act of 1973, as amended by the Workforce Innovation and Opportunity Act ([the Act], Pub. L. 113-128). Section 704 of the Rehabilitation Act requires that, to be eligible to receive financial assistance under Chapter 1, “a State shall submit to the Department, and obtain approval of, a State plan containing such provisions as the Department may require.” The Administration for Community Living's (ACL) approval of the SPIL is required for states to receive federal funding for both the Independent Living Services State grants and Centers for Independent Living programs. Federal statute and regulations require the collection of this information every three years. The current three-year approval period for the SPIL expires April 30, 2019.
The SPIL is jointly developed by the chairperson of the Statewide Independent Living Council and the directors of the centers for independent living in the State, after receiving public input from individuals throughout the State; and signed by the chairperson of the Statewide Independent Living Council, acting on behalf of—and at the direction of—the Council, the director
The proposed data collection tools may be found on the ACL website for review at
Administration for Community Living, HHS.
Notice.
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the
This New Data Collection (ICR New) solicits comments on the information collection requirements relating to the Centers for Independent Living
Comments on the collection of information must be submitted electronically by 11:59 p.m. (EST) or postmarked by December 18, 2018.
Submit electronic comments on the collection of information to: Peter Nye at
Peter Nye, Administration for Community Living, Washington, DC 20024, (202) 795-7606 or
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
With respect to the following collection of information, ACL invites comments on our burden estimates or any other aspect of this collection of information, including:
(1) Whether the proposed collection of information is necessary for the proper performance of ACL's functions, including whether the information will have practical utility;
(2) the accuracy of ACL's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used to determine burden estimates;
(3) ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques when appropriate, and other forms of information technology.
In the context of ACL, IL programs are supported through funding authorized by the Rehabilitation Act of 1973, as amended (The Act). Title VII, chapter 1 of the Act states the current purpose of the program is to “promote a philosophy of independent living including a philosophy of consumer control, peer support, self-help, self-determination, equal access, and individual and system advocacy, in order to maximize the leadership, empowerment, independence, and productivity of individuals with disabilities, and the integration and full inclusion of individuals with disabilities into the mainstream of American society.”
ILS PPR and CIL PPR are being submitted separately because they are separate collections of different information from different parties. Separating these PRA processes reduces confusion and increases the Independent Living Administration's ability to identify issues specific to CILs. This request is for CIL PPR, which is submitted annually by all CILs receiving IL Subchapter C funds. The PPRs are used by ACL to assess grantees' compliance with title VII of the Act, and with 45 CFR 1329 of the Code of Federal
ACL published a
The proposed data collection tools may be found on the ACL website for review at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by December 18, 2018.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 18, 2018. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 of Title 5 of the United States Code authorize Federal agencies to rate applicants for Federal jobs. The proposed information collection involves brief online applications completed by applicants applying to FDA's Fellowship and Traineeship programs. These voluntary online applications will allow the Agency to easily and efficiently elicit and review information from students and healthcare professionals who are interested in becoming involved in FDA-wide activities. The process will reduce the time and cost of submitting written documentation to the Agency and lessen the likelihood of applications being misrouted within the Agency mail system. It will assist the Agency in promoting and protecting the public health by encouraging outside persons to share their expertise with FDA.
FDA estimates the burden of this collection of information as follows:
Because FDA is developing two new training programs, our estimated burden for the information collection reflects an overall increase of 1,050 hours and a corresponding increase of 1,050 responses/records. We attribute this adjustment to an increase in the number of submissions that we will receive with the new training programs.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IMFINZI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Anyone with knowledge that any of the dates as published (see the
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 17, 2019. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product IMFINZI (durvalumab). IMFINZI is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Subsequent to this approval, the USPTO received a patent term restoration application for IMFINZI (U.S. Patent Nos. 8,779,108 and 9,493,565) from MedImmune Limited, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated, January 9, 2018, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of IMFINZI represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for IMFINZI is 1,755 days. Of this time, 1,554 days occurred during the testing phase of the regulatory review period, while 201 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 159 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 20 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Approval is withdrawn as of November 19, 2018.
Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-796-3601.
The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of November 19, 2018. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on November 19, 2018 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
U.S. Coast Guard, Department of Homeland Security.
Notice of Federal Advisory Committee meeting.
The National Maritime Security Advisory Committee will meet in Houston, Texas, to review and discuss various issues relating to national maritime security. All meetings will be open to the public.
The meeting will be held at the Double Tree Hilton Hotel by Houston Hobby Airport, 8181 Airport Boulevard, Houston, TX 77061,
This meeting will be broadcast via a web enabled interactive online format and teleconference line. To participate via teleconference, contact the individual listed in the
For information on facilities or services for individuals with disabilities, or to request special assistance at the meetings, contact the individual listed in
Written comments must be submitted using the Federal eRulemaking Portal:
Mr. Ryan Owens, Alternate Designated Federal Officer of the National Maritime Security Advisory Committee, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593, Stop 7581, Washington, DC 20593-7581; telephone 202-372-1108 or email
Notice of this meeting is in compliance with the
The National Maritime Security Advisory Committee provides advice, consults with, and makes recommendations to the Secretary of Homeland Security, via the Commandant of the Coast Guard, on matters relating to national maritime security.
The Committee will meet to review, discuss and formulate recommendations on the following issues:
(1) Cyber Security Update. Members will receive an update from the U.S. Coast Guard concerning the draft Cyber Security Navigation and Vessel Inspection Circular and other Cyber Security matters related to the Marine Transportation System.
(2) Unmanned Aircraft Systems. The Committee will receive an update from the U.S. Coast Guard concerning the threat of Unmanned Aircraft Systems and the efforts of the U.S. Coast Guard to provide guidance to the maritime industry in addressing the concern these aircraft pose to critical infrastructure.
(3) Port of Houston Maritime Security Review. The Committee will receive a brief on the current state of maritime security at the Port of Houston.
(4) Public Comment period.
The Committee will meet to review, discuss and formulate recommendations on the following issues:
(1) Member Report. The Committee members will each provide an update on the security developments in each of the respective member's representative segment.
(2) Customs-Trade Partnership Against Terrorism. The Committee will receive an update on efforts of from Customs and Border Protection to revise the security requirements of the program.
(3) American Association of Ports Authority Port Security Grant Survey. The Committee will receive a brief on the results of the Survey, conducted over the past year.
(4) Public comment period.
Public comments or questions will be taken throughout the meeting as the Committee discusses the issues and prior to deliberations and voting. There will also be a public comment period at the end of each meeting.
Speakers are requested to limit their comments to 5 minutes. Please note that the public comment period may end before the period allotted, following the last call for comments. Contact the individual listed in the
A copy of all meeting documentation will be available at
Coast Guard, DHS.
Thirty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0095, Oil and Hazardous Material Pollution Prevention and Safety Records, Equivalents/Alternatives and Exemptions; without change. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.
Comments must reach the Coast Guard and OIRA on or before November 19, 2018.
You may submit comments identified by Coast Guard docket number [USCG-2018-0785] to the Coast Guard using the Federal eRulemaking Portal at
(1)
(2)
A copy of the ICR is available through the docket on the internet at
Contact Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection. The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine whether to approve the ICR referred to in this Notice.
We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG-2018-0785], and must be received by November 19, 2018.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
OIRA posts its decisions on ICRs online at
This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (83 FR 39768, August 10, 2018) required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments. Accordingly, no changes have been made to the Collection.
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Coast Guard, DHS.
Notification of issuance of a certificate of alternative compliance.
The Coast Guard announces that the U.S. Coast Guard First District Prevention Department has issued a certificate of alternative compliance from the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), for the Blount Boats Inc., Hull TGI-329. We are issuing this notice because its publication is required by statute. Due to the construction and placement of the vessel's side lights, Hull TGI-329 cannot fully comply with the light, shape, or sound signal provisions of the 72 COLREGS without interfering with the vessel's design and construction. This notification of issuance of a certificate of alternative compliance promotes the Coast Guard's marine safety mission.
The Certificate of Alternative Compliance was issued on October 15, 2018.
For information or questions about this notice call or email Mr. Kevin Miller, First District Towing Vessel/Barge Safety Specialist, U.S. Coast Guard; telephone (617) 223-8272, email
The United States is a signatory to the International Maritime Organization's International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), as amended. The special construction or purpose of some vessels makes them unable to comply with the light, shape, or sound signal provisions of the 72 COLREGS. Under statutory law, however, specified 72 COLREGS provisions are not applicable to a vessel of special construction or purpose if the Coast Guard determines that the vessel cannot comply fully with those requirements without interfering with the special function of the vessel.
The owner, builder, operator, or agent of a special construction or purpose vessel may apply to the Coast Guard District Office in which the vessel is being built or operated for a determination that compliance with alternative requirements is justified,
The First District Prevention Department, U.S. Coast Guard, certifies that the Blount Boats Inc., Hull TGI-329 is a vessel of special construction or purpose, and that, with respect to the position of the vessels side light, it is not possible to comply fully with the requirements of the provisions enumerated in the 72 COLREGS, without interfering with the normal operation, construction, or design of the vessel. The First District Prevention Department further finds and certifies that the vessel's sidelights (12′ 1.67″ from the vessel's side mounted on the pilot house) are in the closest possible compliance with the applicable provisions of the 72 COLREGS.
This notice is issued under authority of 33 U.S.C. 1605(c) and 33 CFR 81.18.
U.S. Immigration and Customs Enforcement, Department of Homeland Security.
30-Day notice and request for comments; extension, without change, of an existing collection of information.
The Department of Homeland Security, U.S. Immigration and Customs Enforcement (USICE) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published in the
Comments are encouraged and will be accepted until November 19, 2018.
Interested persons are invited to submit written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, to the Office of Information and Regulatory
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(1)
(2)
(3)
(4)
(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: 21,711 responses at .5 hours (30 minutes).
(6)
(7)
Fish and Wildlife Service, Interior.
Notice of receipt of permit applications; request for comments.
We, the U.S. Fish and Wildlife Service, have received applications for permits to conduct activities intended to enhance the propagation or survival of endangered or threatened species under the Endangered Species Act, as amended. We invite the public and local, State, Tribal, and Federal agencies to comment on these applications. Before issuing any of the requested permits, we will take into consideration any information that we receive during the public comment period.
We must receive your written comments on or before November 19, 2018.
•
•
Carlita Payne, 612-713-5343;
We, the U.S. Fish and Wildlife Service, invite the public to comment on applications for permits under section 10(a)(1)(A) of the Endangered Species Act, as amended (ESA; 16 U.S.C. 1531
With some exceptions, the ESA prohibits activities that constitute take of listed species unless a Federal permit is issued that allows such activity. The ESA's definition of “take” includes such activities as pursuing, harassing, trapping, capturing, or collecting in addition to hunting, shooting, harming, wounding, or killing.
A recovery permit issued by us under section 10(a)(1)(A) of the ESA authorizes the permittee to conduct activities with endangered or threatened species for scientific purposes that promote recovery or for enhancement of propagation or survival of the species. These activities often include such prohibited actions as capture and collection. Our regulations implementing section 10(a)(1)(A) for these permits are found in the Code of Federal Regulations at 50 CFR 17.22 for endangered wildlife species, 50 CFR 17.32 for threatened wildlife species, 50 CFR 17.62 for endangered plant species, and 50 CFR 17.72 for threatened plant species.
Proposed activities in the following permit requests are for the recovery and enhancement of propagation or survival of the species in the wild. The ESA requires that we invite public comment before issuing these permits. Accordingly, we invite local, State, Tribal, and Federal agencies and the public to submit written data, views, or arguments with respect to these applications. The comments and recommendations that will be most useful and likely to influence agency decisions are those supported by quantitative information or studies.
Written comments we receive become part of the administrative record associated with this action. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can request in your comment that we withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. All submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public disclosure in their entirety.
If we decide to issue permits to any of the applicants listed in this notice, we will publish a notice in the
Section 10(c) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
The Office of the Federal Register received this document for publication on October 15, 2018.
Fish and Wildlife Service, Interior.
Notice of availability; request for comment and information.
We, the Fish and Wildlife Service (Service), have received an application for an incidental take permit (ITP) under the Endangered Species Act. McDonald Ventures XXXVIII, LLC is requesting a 5-year ITP for take of the federally listed sand skink incidental to construction. We request public
To ensure consideration, please send your written comments by November 19, 2018.
If you wish to review the application, including the HCP, as well as our environmental action statement or low-effect screening form, you may request the documents by email, phone, or U.S. mail. These documents are also available for public inspection by appointment during normal business hours at the office below. Send your comments or requests by any one of the following methods.
Erin M. Gawera, telephone: (904) 731-3121; email:
We, the Fish and Wildlife Service (Service), have received an application for an incidental take permit (ITP) under the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531
We have determined that the Applicant's proposal, including the proposed mitigation and minimization measures, would have minor or negligible effects on the species covered in the HCP. Therefore, we have determined that the incidental take permit for this project would be “low effect” and qualify for categorical exclusion under the National Environmental Policy Act (NEPA). A low-effect HCP is one involving (1) minor or negligible effects on federally listed or candidate species and their habitats, and (2) minor or negligible effects on other environmental values or resources.
Before including your address, phone number, email address, or other personal identifying information in your comment, be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may request in your comment that we withhold your personal identifying information, we cannot guarantee that we will be able to do so.
We will evaluate the HCP and comments we receive to determine whether the ITP application meets the permit issuance requirements of section 10(a) of the ESA. We will also conduct an intra-Service consultation pursuant to section 7 of the ESA. If the requirements for permit issuance are met, we will issue ITP number TE98747C-0 to the Applicant for incidental take of the sand skink.
We provide this notice under section 10 of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531
Fish and Wildlife Service, Interior.
Notice of availability; record of decision.
We, the U.S. Fish and Wildlife Service, and the California State Coastal Conservancy, announce the availability of the record of decision (ROD) for the Don Edwards National Wildlife Refuge—Phase 2 of the South Bay Salt Pond Restoration Project final environmental impact statement/environmental impact report. The ROD explains that the selected alternative is the environmentally preferred alternative.
Chris Barr, Deputy Project Leader, 510-792-0222 (phone), or
We, the U.S. Fish and Wildlife Service (Service), and the California State Coastal Conservancy, announce the availability of the record of decision (ROD) for the final environmental impact statement/environmental impact report (EIS/EIR) for Phase 2 of the South Bay Salt Pond Restoration Project (SBSP) at the Don Edwards National Wildlife Refuge. The ROD explains that the selected alternative is the environmentally preferred alternative.
In December 2007, the USFWS and the California Department of Fish and Wildlife (CDFW) published a Final EIS/EIR for the SBSP Restoration Project at the Don Edwards San Francisco Bay National Wildlife Refuge (Refuge) and the CDFW Eden Landing Ecological Reserve (December 19, 2007; 72 FR 71937). The overall south bay salt pond restoration area includes 15,100 acres, which the USFWS and the CDFW
In January 2008, we signed a Record of Decision selecting the Tidal Emphasis Alternative (Alternative C) for implementation. This alternative will result in 90 percent of the USFWS's ponds on the Refuge being restored to tidal wetlands and 10 percent converted to managed ponds. Under Phase 1 of Alternative C, we restored ponds E8A, E8X, E9, E12, and E13 at the Eden Landing complex; A6, A8, A16, and A17 at the Alviso complex; and SF2 at the Ravenswood complex. We also added several trails, interpretive features, and other recreational access points. Construction was completed on the USFWS ponds in 2013.
The SBSP Phase 2 project site is located on the following three geographically separate pond clusters: the Ravenswood Pond Complex (R3, R4, R5, and S5), the Alviso Pond Complex-Mountain View Ponds (A1 and A2W), the Alviso Pond Complex-A8 Ponds (A8 and A8S), and the Alviso Pond Complex-Island Ponds (A19, A20, and A21). These pond clusters are illustrated in Figures 1-5 on the SBSP Restoration Project website at
Phase 2 of the SBSP Restoration Project will restore and enhance over 2,000 acres of tidal wetlands and managed pond habitats in South San Francisco Bay while providing for flood management and wildlife-oriented public access and recreation. On June 3, 2016, we announced the availability of the Final EIS/EIR for Phase 2 (81 FR 35790).
We analyzed a range of alternatives in the Final EIS/EIR, including No Action Alternatives for each group of ponds. The range of alternatives included varying approaches to restoring tidal marshes (including number and location of breaches and other levee modifications), habitat enhancements (islands, transition zones, and channels), modifications to existing levees and berms to maintain or improve flood protection, and recreation and public access components (including trails, boardwalks, and viewing platforms) which correspond to the project objectives.
The alternatives for each group of ponds, or pond cluster, are described briefly below. The no-action alternatives are described together, followed by the action alternatives that were considered for each pond cluster.
Under Alternatives Island A, Mountain View A, A8 A, and Ravenswood A (the no-action alternative at each of these pond clusters), no new activities would be implemented as part of Phase 2. The pond clusters would continue to be monitored and managed through the activities described in the Adaptive Management Plan (AMP) and in accordance with current USFWS practices.
Alternative Island B would breach Pond A19's northern levee and remove or lower levees between Ponds A19 and A20 to increase connectivity and improve the ecological function of both ponds.
Alternative Island C would include the components of Alternative Island B with the addition of levee breaches on the north sides of Ponds A20 and A21, lowering of portions of levees around Pond A20, pilot channels in Pond A19, and widening the existing breaches on the southern levee of Pond A19.
Under Alternative Mountain View B, Ponds A1 and A2W levees would be breached at several points to introduce tidal flow in the ponds. Portions of Pond A1's western levee would be built up to maintain current levels of flood protection provided by the pond itself. Habitat transition zones and habitat islands would be constructed in the ponds to increase habitat complexity and quality for special-status species. A new trail and viewing platform would be installed to improve recreation and public access at these ponds.
Under Alternative Mountain View C, levees would be breached and lowered to increase tidal flows in Pond A1, Pond A2W, and Charleston Slough. The inclusion of Charleston Slough (by breaching and lowering much of Pond A1's western levee) is the primary distinguishing feature between Alternative Mountain View B and Alternative Mountain View C. Several additional new trails and viewing platforms would be installed or replaced to improve recreation and public access at the pond cluster. To continue providing water to the City of Mountain View's Shoreline Park sailing lake, a new water intake would be constructed at the proposed breach between Pond A1 and Charleston Slough.
Alternative A8 B proposes the construction of habitat transition zones in Pond A8S's southwest corner, southeast corner, or both, depending on the amount of material available.
Alternative Ravenswood B would open Pond R4 to tidal flows, improve levees to provide additional flood protection, create habitat transition zone along the western edge of Pond R4, establish managed ponds to improve habitat for diving and dabbling birds, increase pond connectivity, and add a viewing platform to improve recreation and public access.
Alternative Ravenswood C would be similar to Alternative Ravenswood B, with the following exceptions: Ponds R5 and S5 would be converted to a particular type of managed pond that is operated to maintain intertidal mudflat elevation; water control structures would be installed on Pond R3 to allow for improvement to the habitat for western snowy plover; an additional habitat transition zone would be constructed; and two public access and recreational trails and additional viewing platforms would be constructed.
Alternative Ravenswood D would open Pond R4 to tidal flows, improve levees to provide additional flood protection, create two habitat transition zones in Pond R4, establish enhanced managed ponds in Ponds R5 and S5, increase pond connectivity, enhance Pond R3 for western snowy plover
Following public review of the Draft EIS/EIR, USFWS and the California State Coastal Conservancy, in coordination with the Project Management Team and other project partners, identified the preferred alternative, which is based on restoration enhancements at all four pond clusters, as well as maintained or increased flood protection and additional public access and recreation features at two of the Phase 2 pond clusters. The preferred alternative is described in Chapter 6 of the Final EIS/EIR. A summary is provided below.
• At the
• At the
• At the
• At the
The ROD identifies the preferred alternative as the selected alternative. This alternative is also the environmentally preferred alternative. The basis for the decision, descriptions of the alternatives considered, an overview of the measures to be implemented to avoid and minimized environmental effects, and a summary of the public involvement process are provided in the ROD.
We publish this notice under the authority of the National Environmental Policy Act (42 U.S.C. 4371
Fish and Wildlife Service, Interior.
Notice of availability.
We, the U.S. Fish and Wildlife Service, under the National Environmental Policy Act, make available the final environmental impact statement analyzing the impacts of issuance of an incidental take permit (ITP) for implementation of American Electric Power's
We will finalize a record of decision and issue a permit no sooner than November 19, 2018.
You may obtain copies of the documents in the following formats:
•
○
○
○
○
•
○ Department of the Interior, Natural Resources Library, 1849 C Street NW, Washington, DC 20240. Call 202-208-5815.
○ U.S. Fish and Wildlife Service, 500 Gold Avenue SW, Room 6034, Albuquerque, NM 87102. Call 505-248-6920.
○ U.S. Fish and Wildlife Service, 9014 E 21st St., Tulsa, OK 74129. Call 918-581-7458.
Jonna Polk, Field Supervisor, via U.S. mail at Oklahoma Ecological Services Field Office, U.S. Fish and Wildlife Service, 9014 E. 21st St., Tulsa, OK 74129; or via phone at 918-581-7458.
We, the U.S. Fish and Wildlife Service (Service), announce the availability of several documents related to an incidental take permit (ITP) application under the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531
Our proposed action is to issue an ITP to the applicant under section 10(a)(1)(B) of the ESA that authorizes incidental take of the American burying beetle (
The applicant has agreed to include the following minimization measures:
• Reducing erosion by implementing stormwater best practices;
• Limiting use of motor vehicles, machinery, or heavy equipment in occupied ABB habitat to avoid soil compaction;
• Increasing safety during operation fluid use and storage;
• Limiting disturbance from mechanical vegetation management;
• Limiting the use of artificial lighting in occupied ABB habitat; and
• Providing a training program for all personnel conducting or supervising covered activities that may disturb ABB-occupied habitat.
The mitigation measures include the following commitments:
• Relieve soil compaction by disking (mechanically breaking up) compacted soil in laydown areas and material storage areas;
• Revegetate with a native species composition similar to that of the surrounding area (typically warm season grasses) or of the same vegetation type that existed prior to impacts for areas that experienced ground disturbance causing temporary or permanent cover change habitat impacts; and
• Establish off-site habitat mitigation for temporary or permanent cover change and permanent impacts.
In addition to this notice, the Environmental Protection Agency (EPA) is publishing a notice announcing the EIS, as required under the Clean Air Act, section 309 (42 U.S.C. 7401
The applicant has applied for an ITP under the ESA that would authorize incidental take of the ABB and would be in effect for a period of 30 years. The proposed incidental take of the ABB would occur from lawful, non-Federal activities from the applicant's repair, maintenance, and construction activities for electrical lines and support facilities (
Section 9 of the ESA and its implementing regulations in title 50 of the Code of Federal Regulations (CFR) prohibit “take” of fish and wildlife species listed as endangered or threatened under the ESA. The ESA defines “take” as “to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect listed animal species, or attempt to engage in such conduct” (16 U.S.C. 1533). The term “harm” is defined in the regulations as significant habitat modification or degradation that results in death or injury to listed species by significantly impairing essential behavioral patterns, including breeding, feeding, or sheltering (50 CFR 17.3). However, we may, under specified circumstances, issue permits that allow the take of federally listed species, provided that the take is incidental to, but not the purpose of, otherwise lawful activity. Regulations governing ITPs for endangered and threatened species are at 50 CFR 17.22 and 17.32, respectively.
On July 3, 2018, we published a
We received 10 comments in total: 8 Through
We intend to issue an ITP allowing the applicant to implement the proposed HCP, identified as the preferred alternative (Alternative B) in the final EIS. We determined that the preferred alternative best balances the protection and management of habitat for the ABB, while allowing the applicant to supply the public's energy needs. We based our decision on a thorough review of the alternatives and their environmental consequences. Implementing this decision entails issuing an ITP to American Electric Power and full implementation of the HCP, including minimization and mitigation measures, monitoring and adaptive management, and complying with all terms and conditions in the ITP.
In addition to this notice, EPA is publishing a notice in the
The EPA also serves as the repository (EIS database) for EISs that Federal agencies prepare. All EISs must be filed with EPA, which publishes a notice of availability on Fridays in the
We provide this notice under section 10(c) of the ESA (16 U.S.C. 1531
Fish and Wildlife Service, Interior.
Notice of availability; request for comments.
We, the U.S. Fish and Wildlife Service, announce the availability of our draft environmental impact statement (EIS) and a habitat conservation plan (HCP) associated with the incidental take permit (ITP) applications of eleven Collier County landowners under the Endangered Species Act of 1973, as amended. Each
Mr. David Dell, Regional HCP Coordinator, by mail at Attn: ECPO; U.S. Fish and Wildlife Service; 1875 Century Boulevard, Atlanta, GA 30345 or by telephone at 404-679-7313, or Dr. Constance Cassler, Supervisory Fish and Wildlife Biologist, by mail at the South Florida Ecological Services Office, Attn: ECPO; U.S. Fish and Wildlife Service, 1339 20th Street, Vero Beach, FL 32960 or by telephone at 772-469-4356.
We, the U.S. Fish and Wildlife Service (Service), have received applications for ITPs under the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531
The Eastern Collier Property Owners, LLC (ECPO/Applicants) was formed as a collaborative effort to address long-term land-use planning and conservation issues related to the Florida panther in the east Collier County area (see also
Section 9 of the ESA and its implementing regulations prohibit “take” of Federally-listed “threatened” or “endangered” fish and wildlife species. However, section 10(a) of the Act provides exceptions to the prohibition by allowing us to issue permits authorizing take of listed species where such take is incidental to, and not the purpose of, otherwise lawful activities and where the applicant meets certain statutory requirements.
The Applicants' HCP proposes a programmatic approach and framework for engaging in incidental take of the covered species while providing for the permanent protection of portions of the covered lands via conservation easements and generating funding for conservation activities for the covered species in addition to those provided in the HCP. The individual Applicants collectively own a total of 151,779 acres within the approximately 174,000-acre HCP planning area. Under the HCP, up to 45,000 acres could be developed or
We published a notice of intent to prepare an EIS for this HCP in the
The draft EIS assesses the likely environmental impacts associated with the implementation of the activities proposed in the HCP, compared to the likely consequences of not issuing the requested ITPs,
If you wish to comment on the HCP, or draft EIS, you may submit comments by any one of the methods listed above in
We will evaluate the HCP, draft EIS, and your comments to determine whether the collective ITP application meets the permit issuance requirements of section 10(a) of the ESA. We will also conduct an intra-Service consultation pursuant to section 7 of the ESA. If the requirements for permit issuance are met, we will issue individual ITPs to the Applicants.
We provide this notice under section 10 of the ESA (16 U.S.C. 1531
Fish and Wildlife Service, Interior.
Notice of availability; request for comment.
We, the U.S. Fish and Wildlife Service, have received an application from Lantana, LLC for a 5-year incidental take permit under the Endangered Species Act of 1973, as amended (Act). The permit would authorize “take” of the federally endangered Mount Hermon June beetle, incidental to the otherwise lawful activities associated with the demolition of a single-family home and construction of two duet homes at 22 Blake Lane, Scotts Valley, Santa Cruz County, California. We invite comments from the public on the application package, which includes a low-effect habitat conservation plan.
To ensure consideration, please send your written comments by November 19, 2018.
You may download a copy of the draft habitat conservation plan, draft environmental action statement, and draft low-effect screening form at
Karen Sinclair, Fish and Wildlife Biologist, by U.S. mail to the Ventura address in
We have received an application from Lantana, LLC for a 5-year incidental take permit under the Act. The application addresses the potential for take of the federally endangered Mount Hermon June beetle (
The U.S. Fish and Wildlife Service (Service) listed the Mount Hermon June beetle as endangered on January 24, 1997 (62 FR 3616). Section 9 of the Act (16 U.S.C. 1531
Lantana, LLC (hereafter, the applicant) has submitted a low-effect HCP in support of their application for an incidental take permit (ITP) to address take of the Mount Hermon June beetle that is likely to occur as the result of direct impacts on up to 0.32 acre (ac) (14,031 square feet (sf)) of degraded
The applicant proposes to avoid, minimize, and mitigate take of Mount Hermon June beetle associated with the covered activities by fully implementing the HCP. The following measures will be implemented: (1) Locating the project on a developed parcel where habitat is more degraded relative to intact habitat; (2) Avoiding the flight season, if possible, and using plastic sheeting or other soil-covering material to prevent Mount Hermon June beetles from burrowing into exposed soil in the construction site when/if soil disturbing activities must occur between May and August; (3) Having a qualified biologist translocate any larval beetles unearthed during construction activities to a portion of the project site outside of the impact area that supports intact vegetation; (4) Minimizing hardscaping associated with the project, and using native Sandhills plants and non-invasive ornamental plants in landscape areas; (5) Minimizing removal of native trees on the site, including the ponderosa pines and coast live oaks; (6) Revegetating areas of temporary habitat disturbance with native and non-invasive ornamental plants that do not degrade Mount Hermon June beetle habitat; and (7) Securing off-site mitigation at a ratio of 1:1 to mitigate for habitat impacts through the acquisition of 0.32 ac (14,031 sf) of conservation credits at the Zayante Sandhills Conservation Bank. The applicant will fund all elements of the proposed conservation strategy to ensure implementation of all minimization measures, monitoring, and reporting requirements identified in the HCP.
The Service has made a preliminary determination that issuance of the incidental take permit is neither a major Federal action that will significantly affect the quality of the human environment within the meaning of section 102(2)(C) of NEPA (42 U.S.C. 4321
We request comments on our determination that the applicant's proposal will have a minor or negligible effect on the Mount Hermon June beetle and that the plan qualifies as a low-effect HCP. We will evaluate the permit application, including the plan and comments we receive, to determine whether the application meets the requirements of section 10(a)(1)(B) of the Act. We will use the results of our internal Service consultation, in combination with the above findings, in our final analysis to determine whether to issue the ITP. If the requirements are met, we will issue the ITP to the applicant. We will make the final permit decision no sooner than 30 days after the publication date of this notice.
If you wish to comment on the permit application, HCP, and associated documents, you may submit comments by any one of the methods in
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public view, we cannot guarantee that we will be able to do so.
We provide this notice under section 10 of the Act (16 U.S.C. 1531
Bureau of Indian Affairs, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Education (BIE) are proposing to renew an information collection.
Interested persons are invited to submit comments on or before November 19, 2018.
Send written comments on this information collection request (ICR) to the Office of Management and Budget's Desk Officer for the Department of the Interior by email at
To request additional information about this ICR, contact Dr. Joe Herrin, phone: (202) 208-7658. You may also view the ICR at
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
A
We are again soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BIE; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BIE enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BIE minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
National Park Service, Interior.
Notice; correction.
The Fowler Museum at the University of California Los Angeles (UCLA) has corrected an inventory of human remains and associated funerary objects, published in a Notice of Inventory Completion in the
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to the Fowler Museum at UCLA at the address in this notice by November 19, 2018.
Wendy G. Teeter, Ph.D., Fowler Museum at UCLA, Box 951549, Los Angeles, CA 90095-1549, telephone (310) 825-1864, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the correction of an inventory of human remains and associated funerary objects under the control of the Fowler Museum at UCLA, Los Angeles, CA. The human remains and associated funerary objects were removed from Los Angeles and Santa Barbara Counties, CA.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.
This notice corrects the minimum number of individuals and associated funerary objects published in a Notice of Inventory Completion in the
In the
At an unknown date between 1900 and 1950, human remains representing, at minimum, 26 individuals were removed from Sequit Creek Indian Mound (CA-LAN-52) in Los Angeles County, CA.
In the
The fragmentary human remains represent 20 adult individuals, sex unknown, one sub-adult individual (sex unknown), three juvenile individuals (sex unknown) and two infant individuals (sex unknown).
In the
The two associated funerary objects include two unmodified faunal bones.
In the
At an unknown date, human remains representing, at minimum, four individuals
In the
The fragmentary human remains represent four individuals of unknown age and sex.
In the
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of 1,827 individuals of Native American ancestry.
In the
• Pursuant to 25 U.S.C. 3001(3)(A), the 46,017 objects described in this notice are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to Wendy G. Teeter, Ph.D., Fowler Museum at UCLA, Box 951549, Los Angeles, CA 90095-1549, telephone (310) 825-1864, email
The Fowler Museum is responsible for notifying the Santa Ynez Band of Chumash Mission Indians of the Santa Ynez Reservation, California that this notice has been published.
National Park Service, Interior.
Notice.
The Fowler Museum at the University of California Los Angeles (UCLA), in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, has determined that the cultural items listed in this notice meet the definition of unassociated funerary objects. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request to the Fowler Museum at UCLA. If no additional claimants come forward, transfer of control of the cultural items to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request with information in support of the claim to the Fowler Museum at UCLA at the address in this notice by November 19, 2018.
Wendy G. Teeter, Ph.D., Fowler Museum at UCLA, Box 951549, Los Angeles, CA 90095-1549, telephone (310) 825-1864, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3005, of the intent to repatriate cultural items under the control of the Fowler Museum at UCLA that meet the definition of unassociated funerary objects under 25 U.S.C. 3001.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American cultural items. The National Park Service is not responsible for the determinations in this notice.
In 1978 and 1979, 132 cultural items were removed from Lindero Canyon (CA-VEN-606) in Ventura County, CA. Collections from the site derive from the survey and excavation undertaken during the North Ranch Inland Chumash research project, led by Dr. William Clewlow Jr., on land privately owned by the Prudential Insurance Company. A cemetery was discovered during the 1979 excavations. Thirteen burials were uncovered and left in-situ, but burial objects were removed for study. The unassociated funerary objects were removed from six of the burials and were transferred to UCLA in 1979. The site has been dated to the Late Period, A.D. 1300-1650. The 132 unassociated funerary objects are: 12 pieces and four bags of shell fragments, two shell beads, 62 stone flakes, one cobble, three quartz crystals, 41 pieces and two bags of unmodified animal bone fragments, four ochre fragments, and one charcoal lump.
Officials of the Fowler Museum at UCLA have determined that:
• Pursuant to 25 U.S.C. 3001(3)(B), the 132 cultural items described above are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony and are believed, by a preponderance of the evidence, to have been removed from the specific burial sites of Native American individuals.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the unassociated funerary objects and the Santa Ynez Band of Chumash Mission Indians of the Santa Ynez Reservation, California.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request with information in support of the claim to Wendy G. Teeter, Ph.D., Fowler Museum at UCLA, Box 951549, Los Angeles, CA 90095-1549, telephone (310) 825-1864, email
The Fowler Museum at UCLA is responsible for notifying the Santa Ynez Band of Chumash Mission Indians of the Santa Ynez Reservation, California that this notice has been published.
National Park Service, Interior.
Notice.
The Department of Anthropology at Indiana University has completed an inventory of human remains in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the Indiana University NAGPRA Office. If no additional requestors come forward, transfer of control of the human remains to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to the Indiana University NAGPRA Office at the address in this notice by November 19, 2018.
Dr. Jayne-Leigh Thomas, NAGPRA Director, Indiana University, NAGPRA Office, Student Building 318, 701 E Kirkwood Avenue, Bloomington, IN 47405, telephone (812) 856-5315, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects under the control of the Department of Anthropology at Indiana University, Bloomington, IN. The human remains were removed from an unknown location.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by Indiana University professional staff in consultation with representatives of the Alabama-Coushatta Tribe of Texas (previously listed as the Alabama-Coushatta Tribes of Texas); Alabama-Quassarte Tribal Town; Coushatta Tribe of Louisiana; Kialegee Tribal Town; Miccosukee Tribe of Indians of Florida; Poarch Band of Creeks (previously listed as the Poarch Band of Creek Indians of Alabama); Seminole Tribe of Florida (previously listed as the Seminole Tribe of Florida (Dania, Big Cypress, Brighton, Hollywood & Tampa Reservations)); The Muscogee (Creek) Nation; The Seminole Nation of Oklahoma; and the Thlopthlocco Tribal Town, hereafter referred to as “The Tribes.”
In 1956, human remains representing, at minimum, one individual were donated to the Department of Anthropology at Indiana University from the Cincinnati Society of Natural History. Notes indicate that these human remains may have been part of the Chicago Historical Society collections prior to 1950. The human remains are labeled as being from a Creek individual. No other information is present. No known individuals were identified. No associated funerary objects are present.
Descendants of the Creek Confederacy are members of the federally-recognized tribes of the Alabama-Quassarte Tribal Town, Oklahoma; Kialegee Tribal Town, Oklahoma; Muscogee (Creek) Nation, Oklahoma; Poarch Band of Creek Indians of Alabama; Alabama-Coushatta Tribe of Texas; Coushatta Tribe of Louisiana; Seminole Nation of Oklahoma; Seminole Tribe of Florida; Miccosukee Tribe of Indians of Florida; and the Thlopthlocco Tribal Town, Oklahoma.
Officials of the Department of Anthropology at Indiana University have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and The Tribes.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to Dr. Jayne-Leigh Thomas, NAGPRA Director, Indiana University, NAGPRA Office, Student Building 318, 701 E Kirkwood Avenue, Bloomington, IN 47405, telephone (812) 856-5315, email
The Indiana University NAGPRA Office is responsible for notifying The Tribes that this notice has been published.
National Park Service, Interior.
Notice.
The Department of Anthropology at Indiana University has completed an inventory of human remains in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and present-day Indian Tribes or Native Hawaiian organizations. Lineal
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to the Indiana University NAGPRA Office at the address in this notice by November 19, 2018.
Dr. Jayne-Leigh Thomas, NAGPRA Director, Indiana University, NAGPRA Office, Student Building 318, 701 E Kirkwood Avenue, Bloomington, IN 47405, telephone (812) 856-5315, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains under the control of the Department of Anthropology at Indiana University, Bloomington, IN. The human remains were removed from an unknown location.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by Indiana University professional staff in consultation with representatives of Alabama-Coushatta Tribe of Texas (previously listed as the Alabama-Coushatta Tribes of Texas); Alabama-Quassarte Tribal Town; Coushatta Tribe of Louisiana; Jena Band of Choctaw Indians; Kialegee Tribal Town; Miccosukee Tribe of Indians; Mississippi Band of Choctaw Indians; Poarch Band of Creeks (previously listed as the Poarch Band of Creek Indians of Alabama); Seminole Tribe of Florida (previously listed as the Seminole Tribe of Florida (Dania, Big Cypress, Brighton, Hollywood & Tampa Reservations)); The Choctaw Nation of Oklahoma; The Muscogee (Creek) Nation; The Seminole Nation of Oklahoma; and the Thlopthlocco Tribal Town, hereafter referred to as “The Tribes.”
In 1956, human remains representing, at minimum, one individual were donated to the Department of Anthropology at Indiana University from the Cincinnati Society of Natural History. Notes indicate that these human remains may have been part of the Chicago Historical Society collections prior to 1950. The human remains are labeled as being from a Choctaw-Creek individual. No other information is present. Choctaw descendants are members of the federally-recognized tribes of The Choctaw Nation of Oklahoma, the Jena Band of Choctaw Indians, and the Mississippi Band of Choctaw Indians. Descendants of the Creek Confederacy are members of the federally-recognized tribes of the Alabama-Quassarte Tribal Town, Oklahoma; Kialegee Tribal Town, Oklahoma; Muscogee (Creek) Nation, Oklahoma; Poarch Band of Creek Indians of Alabama; Alabama-Coushatta Tribe of Texas; Coushatta Tribe of Louisiana; Seminole Nation of Oklahoma; Seminole Tribe of Florida; Miccosukee Tribe of Indians of Florida; and the Thlopthlocco Tribal Town, Oklahoma.
Officials of the Department of Anthropology at Indiana University have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and The Tribes.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to Dr. Jayne-Leigh Thomas, NAGPRA Director, Indiana University, NAGPRA Office, Student Building 318, 701 E Kirkwood Avenue, Bloomington, IN 47405, telephone (812) 856-5315, email
The Indiana University NAGPRA Office is responsible for notifying The Tribes that this notice has been published.
National Park Service, Interior.
Notice.
The Fowler Museum at the University of California Los Angeles (UCLA) has completed an inventory of human remains, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the Fowler Museum at UCLA. If no additional requestors come forward, transfer of control of the human remains to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to the Fowler Museum at UCLA at the address in this notice by November 19, 2018.
Wendy G. Teeter, Ph.D., Fowler Museum at UCLA, Box 951549, Los Angeles, CA 90095-1549, telephone (310) 825-1864, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the Fowler Museum at UCLA professional staff in consultation with representatives of the Campo Band of Diegueno Mission Indians of the Campo Indian Reservation, California; Capitan Grande Band of Diegueno Mission Indians of California (Barona Group of Capitan Grande Band of Mission Indians of the Barona Reservation, California; Viejas (Baron Long) Group of Capitan Grande Band of Mission Indians of the Viejas Reservation, California); Ewiiaapaayp Band of Kumeyaay Indians, California; Iipay Nation of Santa Ysabel, California (previously listed as the Santa Ysabel Band of Diegueno Mission Indians of the Santa Ysabel Reservation); Inaja Band of Diegueno Mission Indians of the Inaja and Cosmit Reservation, California; Jamul Indian Village of California; La Posta Band of Diegueno Mission Indians of the La Posta Indian Reservation, California; Manzanita Band of Diegueno Mission Indians of the Manzanita Reservation, California; Mesa Grande Band of Diegueno Mission Indians of the Mesa Grande Reservation, California; San Pasqual Band of Diegueno Mission Indians of California; and Sycuan Band of the Kumeyaay Nation (hereafter referred to as “The Tribes”).
In 1958 and 1959, human remains representing, at minimum, three individuals were collected from CA-SDI-525 (W-9) in San Diego County, CA, by Carl L. Hubbs, G. Shumway, J.R. Moriarty, and Claude Warren in the course of conducting excavations at the site during the construction of two homes in Scripps Estates. The site dates to the Middle Holocene (between 7,000 and 5,500 B.P.) based on radiocarbon dating. Altogether, 16 burials were uncovered, seven of which were left in situ. In 1959, the collections of the other nine burials were sent to UCLA. Subsequently, the collections from seven of these burials were transferred to the University of California, Scripps Institution of Oceanography, while the collections from Burials 9 and 10 remained at UCLA. The identified human remains from Burials 9 and 10 were reportedly sent to “Stanford” for dating. Despite extensive investigations, at this time, the Fowler Museum at UCLA cannot locate these human remains. The human remains in this notice are fragments that were found with faunal remains. They represent two juvenile individuals of unknown sex and one individual of undetermined age and sex. No known individuals were identified. No associated funerary objects were identified.
Based on archeological evidence, geographic location, ethnographic information, and oral history evidence, these human remains have been identified as Native American. Site CA-SDI-525 has been identified through consultation with The Tribes to be within the lands traditionally occupied by the Kumeyaay Nation, which is composed of The Tribes.
Officials of the Fowler Museum at UCLA have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of three individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and The Tribes.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to Wendy G. Teeter, Ph.D., Fowler Museum at UCLA, Box 951549, Los Angeles, CA 90095-1549, telephone (310) 825-1864, email
The Fowler Museum at UCLA is responsible for notifying The Tribes that this notice has been published.
National Park Service, Interior.
Notice; correction.
The Fowler Museum at the University of California Los Angeles (UCLA) has corrected an inventory of human remains and associated funerary objects, published in a Notice of Inventory Completion in the
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to the Fowler Museum at UCLA at the address in this notice by November 19, 2018.
Wendy G. Teeter, Ph.D., Fowler Museum at UCLA, Box 951549, Los Angeles, CA 90095-1549, telephone (310) 825-1864, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the correction of an inventory of human remains under the control of the Fowler Museum at UCLA, Los Angeles, CA. The human remains were removed from Los Angeles County, CA.
This notice is published as part of the National Park Service's administrative
This notice corrects the minimum number of individuals published in a Notice of Inventory Completion in the
In the
In 1981 and 1984, human remains representing, at minimum, four individuals were removed from Playa del Rey Site #2 (CA-LAN-61), also known as the Loyola Marymount Site, in Los Angeles County, CA.
In the
The site was surface collected by Vincent Lambert and excavated by the Archeological Associates of Sun City.
In the
One adult individual represented by burned cranial and limb fragment, two juvenile individuals of unknown sex are represented by a single tooth each, and one infant individual represented by a molar were identified.
In the
In 1981 and 1986, human remains representing, at minimum, 13 individuals were removed from Playa del Rey Site #4 (CA-LAN-63), also known as The Del Rey Site, in Los Angeles County, CA.
In the
The site was surface collected by Vincent Lambert and excavated by the Archeological Associates of Sun City.
In the
Fragmentary human remains represent two adults (some burned), one juvenile, and ten individuals that could not be identified to age or sex.
In the
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of 58 individuals of Native American ancestry based on metric and non-metric analysis.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to Wendy G. Teeter, Ph.D., Fowler Museum at UCLA, Box 951549, Los Angeles, CA 90095-1549, telephone (310) 825-1864, email
The Fowler Museum is responsible for notifying the San Manuel Band of Mission Indians, California (previously listed as the San Manual Band of Serrano Mission Indians of the San Manual Reservation) that this notice has been published.
National Park Service, Interior.
Notice.
The Field Museum has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the Field Museum. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to the Field Museum at the address in this notice by November 19, 2018.
Helen Robbins, The Field Museum, 1400 South Lake Shore Drive, Chicago, IL 60605, telephone (312) 665-7317, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects under the control of the Field Museum, Chicago, IL. The human remains and associated funerary objects were removed from Homolovi I and Homolovi II, Navajo County, AZ.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains and associated funerary objects. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the Field Museum professional staff in consultation with representatives of the Hopi Tribe of Arizona and the Zuni Tribe of the Zuni Reservation, New Mexico.
In 1899, human remains representing, at minimum, 20 individuals were removed from Homolovi I in Navajo County, AZ. The individuals were excavated by J. A. Burt, an employee of the Field Museum, as part of an excavation occurring in the winter of
Homolovi I was occupied from around A.D. 1285 to 1390. Based on archeological research, scholarly research, consultation, and museum records, Homolovi I is affiliated with the Hopi Tribe of Arizona and the Zuni Tribe of the Zuni Reservation, New Mexico.
In 1899, human remains representing, at minimum, 33 individuals were removed from Homolovi II in Navajo County, AZ. The individuals were excavated by J. A. Burt, an employee of the Field Museum, as part of an excavation occurring in the winter of 1899-1900 sponsored by the Museum. No known individuals were identified. The 49 associated funerary objects are seven faunal remains, 29 bowls, four awls, one selenite sheet, one bone whistle, one bone bead, one ladle, two water vessels, two jars, and one cloth fragment. Homolovi II was occupied from around A.D. 1350 to 1400. Based on archeological research, scholarly research, consultation, and museum records, Homolovi II is affiliated with the Hopi Tribe of Arizona and the Zuni Tribe of the Zuni Reservation, New Mexico.
In 1899, human remains representing, at minimum, three individuals were removed from Homolovi I or Homolovi II in Navajo County, AZ. The individuals were excavated by J. A. Burt, an employee of the Field Museum, as part of an excavation occurring in the winter of 1899-1900 sponsored by the Museum. No known individuals were identified. No associated funerary objects are present.
Officials of the Field Museum have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of 56 individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A), the 73 objects described in this notice are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and associated funerary objects and the Hopi Tribe of Arizona and the Zuni Tribe of the Zuni Reservation, New Mexico.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to Helen Robbins, The Field Museum, 1400 South Lake Shore Drive, Chicago, IL 60605, telephone (312) 665-7317, email
The Field Museum is responsible for notifying the Hopi Tribe of Arizona and the Zuni Tribe of the Zuni Reservation, New Mexico that this notice has been published.
National Park Service, Interior.
Notice.
The Fowler Museum at the University of California Los Angeles (UCLA), in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, has determined that the cultural items listed in this notice meet the definition of unassociated funerary objects. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request to the Fowler Museum at UCLA. If no additional claimants come forward, transfer of control of the cultural items to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request with information in support of the claim to the Fowler Museum at UCLA at the address in this notice by November 19, 2018.
Wendy G. Teeter, Ph.D., Fowler Museum at UCLA, Box 951549, Los Angeles, CA 90095-1549, telephone (310) 825-1864, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3005, of the intent to repatriate cultural items under the control of the Fowler Museum at UCLA that meet the definition of unassociated funerary objects under 25 U.S.C. 3001.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American cultural items. The National Park Service is not responsible for the determinations in this notice.
In 1958 and 1959, three cultural items were removed from CA-SDI-525 (W-9) in San Diego County, CA. Carl L. Hubbs, G. Shumway, J. Moriarity, and Claude Warren conducted excavations during the construction of two homes on Scripps Estate Association Lots. The site was dated to the Middle Holocene (between 7,000 and 5,500 B.P.) based on radiocarbon dating. In 1959, the collections were sent to UCLA for curation. 16 burials were uncovered, of which seven were left in situ, two burials (9 and 10) were supposedly sent to UCLA, and the rest were curated with J.R. Moriarty, UC Scripps Institution of Oceanography. Burials 9 and 10 cannot currently be located, although they are reported to have been sent to “Stanford” for dating and despite extensive investigations. Funerary objects were identified in the collections as being removed from these two burials. There were three objects including one stone metate, one shell fragment, and one soil sample. Since the represented burials have not been located these burial items are eligible as NAGPRA unassociated funerary objects.
The site detailed in the paragraphs preceding has been identified through consultation to be within the aboriginal territory of the Kumeyaay people. Based
Officials of the Fowler Museum at UCLA have determined that:
• Pursuant to 25 U.S.C. 3001(3)(B), the three cultural items described above are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony and are believed, by a preponderance of the evidence, to have been removed from a specific burial site of a Native American individual.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the unassociated funerary objects and The Tribes.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request with information in support of the claim to Wendy G. Teeter, Ph.D., Fowler Museum at UCLA, Box 951549, Los Angeles, CA 90095-1549, telephone (310) 825-1864, email
The Fowler Museum at UCLA is responsible for notifying The Tribes that this notice has been published.
Bureau of Ocean Energy Management, Interior.
Final Sale Notice for Commercial Leasing for Wind Power on the Outer Continental Shelf Offshore Massachusetts.
This document is the Final Sale Notice (FSN) for the sale of commercial wind energy leases on the Outer Continental Shelf (OCS) offshore Massachusetts. The Bureau of Ocean Energy Management (BOEM) will offer three leases: Lease OCS-A 0520, Lease OCS-A 0521, and Lease OCS-A 0522 (Lease Areas), which are located within the former Leases OCS-A 0502 and Lease OCS-A 0503 that were unsold during the Atlantic Wind Lease Sale-4 (ATLW-4) on January 29, 2015. BOEM will use an ascending bidding auction format. The FSN contains information pertaining to the areas available for leasing, certain provisions and conditions of the leases, auction details, the lease form, criteria for evaluating competing bids, award procedures, appeal procedures, and lease execution. The issuance of the lease(s) resulting from this sale would not constitute an approval of project-specific plans to develop offshore wind energy. Such plans, if submitted by the lessee, would be subject to subsequent environmental, technical, and public reviews prior to a decision on whether the proposed development should be authorized.
BOEM will hold a mock auction for the bidders starting at 9:00 a.m. Eastern Standard Time (EST) on December 11, 2018. The monetary auction will be held online and will begin at 9:00 a.m. EST on December 13, 2018. Additional details are provided in the section entitled “Deadlines and Milestones for Bidders.”
Jeff Browning, BOEM, Office of Renewable Energy Programs, 45600 Woodland Road, VAM-OREP, Sterling, Virginia 20166, (703) 787-1577 or
In response to the PSN, BOEM received new qualification materials from thirteen entities that BOEM has determined to be qualified to participate in this sale, and four affirmations of interest from entities that were qualified to participate in the first Massachusetts Lease Sale (ATLW-4) in January of 2015. In addition, the two entities that submitted unsolicited lease requests for the Lease Areas have also qualified, resulting in a total of 19 qualified entities.
BOEM made several changes from the description of the lease sale format and leases that were published in the PSN. The primary changes are: The lease sale no longer contains a non-monetary bidding credit, and will instead use a straight ascending bid format; the two proposed lease areas have been re-divided into three Lease Areas; each lease now contains conditions related to vessel transit corridors and setbacks between adjacent leases; and the operations term of each lease has been extended from 25 years to 33 years.
List of Eligible Bidders: BOEM has determined that the following entities are legally, technically, and financially
BOEM considers two entities to be affiliated if (a) one entity (or its parent or subsidiary) has or retains any right, title, or interest in the other entity (or its parent or subsidiary), including any ability to control or direct actions with respect to such entity, either directly or indirectly, individually or through any other party; or (b) the entities are both direct or indirect subsidiaries of the same parent company.
•
•
•
•
•
•
•
•
•
•
A large scale map of the Lease Areas, showing boundaries of the area with numbered blocks, is available from BOEM upon request at the following address: Bureau of Ocean Energy Management, Office of Renewable Energy Programs, 45600 Woodland
BOEM will conduct additional environmental reviews upon receipt of a lessee's proposed project-specific plans, such as a Site Assessment Plan (SAP) or Construction and Operations Plan (COP). As conditions of plan approval, Lessees may be required to contribute to regional environmental monitoring programs that are presently being developed jointly between state and Federal authorities and stakeholder groups. For Lease OCS-A 0522, BOEM may require terms and conditions of project approval aimed at mitigating, minimizing, or avoiding impacts to sea ducks. During the development of the Massachusetts WEA, BOEM took steps to protect sea ducks (among other species) by removing lease blocks. Recent information suggests that high concentrations of sea ducks may forage in the easternmost lease blocks (6251, 6252, & 6302) during the winter months.
BOEM is also adding additional lease stipulations that were not contained in the leases offered in ATLW-4.
• Addendum “A” (Description of Leased Area and Lease Activities);
• Addendum “B” (Lease Term and Financial Schedule);
• Addendum “C” (Lease Specific Terms, Conditions, and Stipulations);
• Addendum “D” (Project Easement);
• Addendum “E” (Rent Schedule post-COP approval);
• Appendix A to Addendum “C” (Incident Report: Protected Species Injury or Mortality); and
• Appendix B to Addendum “C” (Required Data Elements for Protected Species Observer Reports).
Addenda “A,” “B,” and “C” provide detailed descriptions of lease terms and conditions. Addenda “D” and “E” will be completed at the time of COP approval or approval with modifications.
The most recent version of BOEM's renewable energy commercial lease form (BOEM-0008) is available on BOEM's website at:
For a 128,811 acre lease (the size of OCS-A 0520), the rent payment will be $386,433 per year if no portion of the lease area is authorized for commercial operations. If 500 megawatts (MW) of a project's nameplate capacity is operating (or authorized for operation), and the approved COP specifies a maximum project size of 800 MW, the rent payment will be $144,912. This payment is based on the 300 MW of nameplate capacity BOEM has not yet authorized for commercial operations. For the above example, this would be calculated as follows: 300MW/800MW × ($3/acre × 128,811 acres) = $144,912.
If the lessee submits an application for relinquishment of a portion of its leased area within the first 45 calendar days following the date that the lease is received by the lessee for execution, and BOEM approves that application, no rent payment will be due on the relinquished portion of the lease area. Later relinquishments of any portion of the lease area will reduce the lessee's rent payments starting in the year following BOEM's approval of the relinquishment.
The lessee must also pay rent for any project easement associated with the lease, commencing on the date that BOEM approves the COP (or modification thereof) that describes the project easement. Annual rent for a project easement that is 200 feet wide and centered on the transmission cable is $70 per statute mile. For any additional acreage required, the lessee must also pay the greater of $5 per acre per year or $450 per year.
The subsequent annual operating fee payments are calculated by multiplying the operating fee rate by the imputed wholesale market value of the projected annual electric power production. For the purposes of this calculation, the imputed market value is the product of the project's annual nameplate capacity, the total number of hours in the year (8,760), the capacity factor, and the annual average price of electricity derived from a historical regional wholesale power price index. For example, the annual operating fee for an 800 MW wind facility operating at a 40% capacity (
The capacity factor for the year in which the Commercial Operation Date occurs, and for the first six full years of commercial operations on the lease, is set to 0.4 (
BOEM will base the amount of all SAP, COP, and decommissioning financial assurance on cost estimates for meeting all accrued lease obligations at the respective stages of development. The required amount of supplemental and decommissioning financial assurance will be determined on a case-by-case basis.
The financial terms described above can be found in Addendum “B” of the leases, which BOEM has made available with this notice on its website at:
BOEM will not consider BFFs submitted by bidders for previous lease sales to satisfy the requirements of this auction. BOEM will also only consider BFFs submitted after the deadline (November 2, 2018) if BOEM determines that the failure to timely submit the BFF was caused by events beyond the bidder's control. BOEM will only accept an original, executed paper copy of the BFF. The BFF must be executed by an authorized representative listed in the qualifications package on file with BOEM as authorized to bind the company.
Following the auction, bid deposits will be applied against bonus bids or other obligations owed to BOEM. If the bid deposit exceeds a bidder's total financial obligation, BOEM will refund the balance of the bid deposit to the bidder. BOEM will refund bid deposits to non-winners once BOEM has announced the provisional winner.
If BOEM offers a lease pursuant to a provisionally winning bid, and that bidder fails to timely return the signed lease form, establish financial assurance, and/or pay the balance of its bid, BOEM will retain the bidder's $450,000 bid deposit. In such a circumstance, BOEM reserves the right to determine which bid would have won in the absence of the bid previously-determined to be the winning bid, and to offer a lease pursuant to this next highest bid.
As authorized under 30 CFR 585.220(a)(2) and 585.221(a)(1), BOEM will use an ascending bidding auction with cash as the bid variable for this lease sale. BOEM will start the auction using the minimum bid prices for each lease area, and increase those prices incrementally until no more than one active bidder per lease area remains in the auction.
Using an online bidding system to host the auction, BOEM will start the bidding for Lease OCS-A 0520 at $257,622, Lease OCS-A 0521 at $254,776, and for Lease OCS-A 0522 at $264,740. Each bidder may bid on only one lease area at a time, and can win at most one of the three Lease Areas offered in this sale.
The auction will be conducted in a series of rounds. At the start of each round, BOEM will state an asking price for each lease area. If a bidder is willing to meet the asking price for one of the lease areas, it will indicate its intent by submitting a bid equal to the asking price. A bid at the full asking price is referred to as a “live bid.” To participate in the next round of the auction, a bidder must submit a live bid for one of the lease areas in each previous round. As long as there are two or more live bids for at least one lease area, the auction moves to the next round. BOEM will raise the asking price for each lease area that has received two or more live bids in the previous round. Asking price increments will be determined based on several factors, including (but not necessarily limited to) the expected time needed to conduct the auction, and the number of rounds that have already occurred. BOEM reserves the right to increase or decrease bidding increments as appropriate.
Generally, a bidder that submitted a live bid in the previous round is free to bid on any of the three areas in the current round. However, there is an exception. A bidder may switch its live bid from one lease area to another in the current round only if its bid from the previous round was contested—
Between rounds, BOEM will disclose to all bidders that submitted bids in the first round of the auction: (1) The number of live bids (including bids carried forward) for each lease area in the previous round of the auction (
A bidder is only eligible to continue bidding in the auction if it has submitted a live bid (or had a bid carried forward) in the previous round. In any round after the first round, however, a bidder may submit an “exit bid” (also known as an “intra-round bid”). An exit bid is a bid that is higher than the previous round's asking price, submitted for the same lease area as the bidder's contested live bid in the previous round, but less than the current round's asking price. An exit bid is
A lease area with only exit bids in a given round will not have its asking price raised in the next round, since BOEM only raises asking prices when a lease area receives multiple
After the bidding ends, BOEM will determine the provisionally winning bids for each lease area. The provisionally winning bid for a lease area will be the highest bid (live bid or exit bid) received for that lease area, except that no bidder may win more than one lease area. The award procedures described here could result in a tie, for example if two bidders submit identical high exit bids. In such cases, BOEM would resolve the tie by randomized means subject to the constraint of no bidder winning more than one lease area. After the last round of the auction, there will be a listing of all scenarios that would generate the same maximum revenue. This can include multiple ties. Each of those scenarios is given an equal probability of winning. The selection of the winning scenario is determined by pseudorandom numbers.
Provisional winners may be disqualified if they are subsequently found to have violated auction rules or BOEM regulations, or otherwise engaged in conduct detrimental to the integrity of the competitive auction. If a bidder submits a bid that BOEM determines to be a provisionally winning bid, the bidder will be expected to sign the applicable lease documents, establish financial assurance, and submit the cash balance of its bid (
For the online auction, BOEM will require two-factor authentication. After BOEM has processed the bid deposits, the auction contractor sends several bidder authentication packages to the bidders. One package will contain digital authentication tokens needed to allow access to the auction website. As a general practice, tokens are mailed to the Primary Point of Contact indicated on the BFF. This individual is responsible for distributing the tokens to the individuals authorized to bid for that company.
The second package contains login credentials for authorized bidders. The login credentials are mailed to the address provided in the BFF for each authorized individual. Bidders can confirm these addresses by calling 703-787-1320. This package will contain user login information and instructions for accessing the Bidder Manual for the auction system, the Auction System Technical Supplement (ASTS) and the Alternative Bidding Form, all of which are available on BOEM's website at:
The auction will begin at 9:00 a.m. EST on December 13, 2018. Bidders may log in as early as 8:30 a.m. on that day. We recommend that bidders log in earlier than 9:00 a.m. on that day to ensure that any login issues are resolved prior to the start of the auction. Once bidders have logged in, they should review the auction schedule, which lists the anticipated start times, end times, and recess times of each round in the auction. Each round is structured as follows:
• Round bidding begins;
• Bidders enter their bids;
• Round bidding ends and the Recess begins;
• During the Recess, previous Round results and next round asking prices are posted;
• Bidders review the previous Round results and prepare their next Round bids; and
• Next Round bidding begins.
The first round will last about 30 minutes, though subsequent rounds may be shorter. Recesses are anticipated to last approximately 10 minutes. The description of the auction schedule included with this FSN is tentative. Bidders should consult the auction schedule on the bidding website during the auction for updated times. Bidding will continue until about 6:00 p.m. EST
BOEM and the auction contractors will use the auction platform messaging service to keep bidders informed on issues of interest during the auction. For example, BOEM may change the schedule at any time, including during the auction. If BOEM changes the schedule during an auction, it will use the messaging feature to notify bidders that a revision has been made, and will direct bidders to the relevant page. BOEM will also use the messaging system for other updates during the auction.
Bidders may place bids at any time during the round. At the top of the bidding page, a countdown clock shows how much time remains in the round. Bidders have until the scheduled time to place bids. Bidders should do so according to the procedures described in this notice, and the ASTS. Information about the round results will only be made available after the round has closed, so there is no strategic advantage to placing bids early or late in the round.
The ASTS will elaborate on the auction procedures described in this FSN. In the event of an inconsistency between the ASTS and the FSN, the FSN is controlling.
During the auction, bidders are prohibited from communicating with each other regarding their participation in the auction. Also during the auction, bidders are prohibited from communicating to the general public regarding any aspect of their participation or lack thereof in the auction, including, but not limited to, through social media, updated websites, or press releases.
Alternate Bidding Procedures enable a bidder who is having difficulty accessing the internet to submit its bid via fax using an Alternate Bidding Form available on BOEM's website at:
In order to be authorized to use an Alternate Bidding Form, a bidder must call the help desk number listed in the Auction Manual
Anti-competitive behavior determinations are fact-specific. However, such behavior may manifest itself in several different ways, including, but not limited to:
• An express or tacit agreement among bidders not to bid in an auction, or to bid a particular price;
• An agreement among bidders not to bid;
• An agreement among bidders not to bid against each other; or
• Other agreements among bidders that have the potential to affect the final auction price.
BOEM will decline to award a lease pursuant to 43 U.S.C. 1337(c) if the Attorney General, in consultation with the Federal Trade Commission, determines that awarding the lease would be inconsistent with the antitrust laws.
For more information on whether specific communications or agreements could constitute a violation of Federal antitrust law, please see
1. Sign and return the lease copies on the bidder's behalf;
2. File financial assurance, as required under 30 CFR 585.515-537; and
3. Pay by electronic funds transfer (EFT) the balance (if any) of the bonus bid (winning bid less the bid deposit). BOEM requires bidders to use EFT procedures (not
BOEM will not execute a lease until the three requirements above have been satisfied, BOEM has accepted the provisionally winning bidder's financial assurance pursuant to 30 CFR 585.515, and BOEM has processed the provisionally winning bidder's payment.
BOEM may extend the 10 business day deadline for signing a lease, filing the required financial assurance, and/or paying the balance of the bonus bid if BOEM determines the delay was caused by events beyond the provisionally winning bidder's control.
If a provisionally winning bidder does not meet these requirements or otherwise fails to comply with applicable regulations or the terms of the FSN, BOEM reserves the right not to issue the lease to that bidder. In such a case, the provisionally winning bidder will forfeit its bid deposit. Also in such a case, BOEM reserves the right to identify the next highest bid for that lease area submitted during the lease sale by a bidder who has not won one of the other lease areas, and to offer the lease to that bidder pursuant to its bid.
Within 45 calendar days of the date that a provisionally winning bidder receives copies of the lease, it must pay the first year's rent using the
Subsequent annual rent payments must be made following the detailed instructions contained in the “Instructions for Making Electronic Payments,” available on BOEM's website at:
(a) If BOEM rejects your bid, BOEM will provide a written statement of the reasons and refund any money deposited with your bid, without interest.
(b) You will then be able to ask the BOEM Director for reconsideration, in writing, within 15 business days of bid rejection, under 30 CFR 585.118(c)(1). We will send you a written response either affirming or reversing the rejection.
The procedures for appealing final decisions with respect to lease sales are described in 30 CFR 585.118(c).
If you wish to protect the confidentiality of such information, clearly mark it “Contains Privileged or Confidential Information” and consider submitting such information as a separate attachment. BOEM will not disclose such information, except as required by FOIA. Information that is not labeled as privileged or confidential may be regarded by BOEM as suitable for public release. Further, BOEM will not treat as confidential aggregate summaries of otherwise confidential information.
Bureau of Ocean Energy Management, Interior.
Call for Information and Nominations (hereinafter referred to as “Call” or “notice”) for Commercial Leasing for Wind Power Development on the OCS offshore California.
The Bureau of Ocean Energy Management (BOEM) invites the submission of information and nominations for commercial wind leases that would allow a lessee to propose the construction of a wind energy project on the OCS offshore California, and to develop one or more projects, if approved, after further environmental review. This is not a leasing announcement, but the Call Areas or portions of Call Areas described may be available for future leasing. BOEM will use responses to this Call to gauge specific interest in acquiring commercial wind leases in some or all of the Call Areas. Any nominations submitted in response to this Call should provide detailed and specific information addressing the requirements described in the section of this notice entitled, “Required Nomination Information.”
This Call also requests comments and information regarding site conditions, resources, and multiple uses in close proximity to, or within, the Call Areas that would be relevant to BOEM's review of the nominations or to any subsequent decision whether to offer all or part of the Call Areas for commercial wind leasing. In providing this information, please refer to the section of this Call entitled, “Requested Information from Interested or Affected Parties.”
BOEM must receive nominations describing your interest in one or more, or any portion of, the Call Areas, by a postmarked date of January 28, 2019 for your nomination to be considered. BOEM requests comments or submissions of information to be postmarked or delivered by this same date.
If you are submitting a nomination for a lease area in response to this Call, please submit your nomination, following the “Required Nomination Information” section below, to the following address: BOEM, Office of Strategic Resources, 760 Paseo Camarillo (Suite 102), Camarillo, California 93010. In addition to a paper copy of the nomination, include an electronic copy of the nomination on a data storage device. BOEM will list the parties that submitted nominations and the location of the proposed lease areas (
Comments and other information may be submitted by either of the following two methods:
1.
2. U.S. Postal Service or other delivery service. Send your comments and information to the following address: Bureau of Ocean Energy Management, Office of Strategic Resources, 760 Paseo Camarillo (Suite 102), Camarillo, California 93010.
BOEM will post all responses on
Jean Thurston, BOEM California Intergovernmental Renewable Energy Task Force Coordinator, BOEM, Office of Strategic Resources, 760 Paseo Camarillo (Suite 102), Camarillo, California 93010, (805) 384-6303 or
This Call is published pursuant to section 8(p)(3) of the Outer Continental
The three (3) geographically distinct Call Areas described in this notice are located on the OCS offshore California and are the Humboldt Call Area on the north coast and the Morro Bay Call Area and the Diablo Canyon Call Area on the central coast. These areas include 85 whole OCS blocks and 573 partial blocks in total, and comprise approximately 1,073 square statute miles (mi) (687,823 acres). If BOEM determines that there is competitive interest in these areas, BOEM will identify which areas will be subject to an environmental analysis and consideration for leasing as part of the area identification portion of the competitive leasing process. A detailed description of the areas and how they were developed is described in the section of this Call entitled, “Description of the Area.”
OCSLA requires BOEM to award leases competitively, unless BOEM determines that there is no competitive interest (43 U.S.C. 1337(p)(3)). On January 14, 2016, BOEM received an unsolicited lease request from Trident Winds, LLC (Trident Winds) for the development of a wind energy project offshore Morro Bay, on the central coast of California. On August 18, 2016, BOEM published the
On September 11, 2018, BOEM received an unsolicited lease request from the Redwood Coast Energy Authority (RCEA) for the development of a wind energy project offshore Humboldt County. RCEA submitted its request after issuing a Request for Qualifications (RFQ) on February 1, 2018, to select one or more qualified entities to enter into a public-private partnership pursuant to their activities to pursue developing an offshore wind energy project off Humboldt County. The RCEA received responses on their RFQ from six entities, and in April 2018 selected partners for the project. The area requested by RCEA in its unsolicited lease request is included in the Humboldt Call Area.
BOEM will use responses to this Call to confirm competitive interest in the portions of the Call Areas for which BOEM already has information, as well as to solicit new expressions of interest in obtaining a lease within the Call Area(s).
BOEM will make a formal determination of competitive interest after reviewing the nominations and comments provided in response to this Call. Depending on the nominations and comments received, BOEM may proceed with the competitive leasing process as set forth in 30 CFR 585.211 through 585.225; may proceed with the noncompetitive leasing process as set forth in 30 CFR 585.231 and 232; or may decide not to proceed with leasing. BOEM may also determine that some of the Call Areas or portions of Call Areas have competitive interest while other area do not. For instance, BOEM may determine that there is no competitive interest in the Humboldt Call Area and that there is competitive interest in the Morro Bay and Diablo Canyon Call Areas. In this case, BOEM could proceed with the noncompetitive leasing process for the Humboldt Call Area and with the competitive leasing process for the Morro Bay and Diablo Canyon Call Areas. We explain these processes in detail in the section of this notice entitled, “BOEM's Planning and Leasing Process.”
We note that a lease, whether issued through a competitive or noncompetitive process, does not grant the lessee the right to construct any facilities on the lease. The lease only grants the lessee the exclusive right to submit site assessment and construction and operations plans to BOEM, which BOEM must first approve before the lessee may proceed to the next stages of the process (30 CFR 585.600 and 585.601).
Whether competitive or noncompetitive, the leasing process will include subsequent opportunities for public input, and any proposed actions will be reviewed thoroughly for potential environmental impacts and multiple use conflicts. BOEM has not yet determined which area(s) may be offered for lease, if any, has/have not yet been determined, and may include less than the total footprint of any Call Areas or may offer no leasing at all.
Section 8(p) of OCSLA, authorizes the Secretary of the Interior (“Secretary”) to grant leases, easements, or rights-of-way (ROWs) on the OCS for activities not previously authorized by the OCS Lands Act or other applicable law. Under subsection 8(p)(1)(C), the Secretary of the Interior may issue leases for activities that produce or support production, transportation, or transmission of energy from sources other than oil or gas, including renewable energy sources. Section 8(p) also requires the Secretary to issue any necessary regulations to carry out this authority. Regulations were issued for this purpose on April 29, 2009, and are codified in BOEM regulations at 30 CFR part 585. The Secretary has delegated the authority to issue leases, easements, and ROWs to the Director of BOEM.
BOEM appreciates the importance of coordinating its planning endeavors with other OCS users, relevant Federal and state agencies, and tribes. BOEM and the State of California, through the leadership of the California Energy Commission, have engaged in a collaborative, data-based offshore wind energy planning process to foster coordinated and informed decisions about California's shared ocean resources and the many users who depend on them. This outreach has consisted of numerous public meetings, webinars, and briefings with coastal communities, fishing communities, federally and non-federally recognized tribes, state and Federal agencies, academia and scientists, environmental non-governmental organizations (NGOs), and the offshore renewable energy industry. The summary report on this outreach can be viewed at:
At the request of Governor Brown, BOEM established an Intergovernmental Renewable Energy Task Force (Task Force) with California in 2016 to facilitate coordination among relevant Federal agencies and affected state, local, and tribal governments
The State of California established a Renewables Portfolio Standard (RPS) in 2002. California expanded the RPS in 2015 through passage of Senate Bill 350, the Clean Energy and Pollution Reduction Act, and further expanded the RPS in 2018 through passage of Senate Bill (SB) 100. SB 100 increased the state's RPS requirements for powering the electricity system from renewable energy resources. The legislation requires 50 percent powering from renewable resources by 2025, 60 percent by 2030, and 100 percent powering from zero-carbon resources by December 31, 2045, for retail sales of electricity to California end-use customers and electricity procured to serve state agencies. Additional information about California's RPS is available at:
Before deciding whether and where leases may be issued within the Call Areas, BOEM will prepare an environmental assessment (EA) under the National Environmental Policy Act (NEPA) and conduct consultations to consider the environmental consequences associated with issuing commercial wind leases. As the issuance of a lease does not grant the right to construct any facilities within the lease, the EA will consider reasonably foreseeable environmental consequences associated with leasing, site assessment and site characterization activities (including geophysical, geotechnical, archaeological, and biological surveys). If BOEM issues a lease and the lessee proposes the construction and operation of an offshore wind energy facility, BOEM would consider the environmental effects of such construction and operation under a separate, project-specific NEPA process, which would include additional opportunities for public involvement. BOEM would also conduct consultations under other authorities, including, but not limited to, the Coastal Zone Management Act (CZMA), Endangered Species Act (ESA), the Magnuson-Stevens Fishery Conservation and Management Act, Section 106 of the National Historic Preservation Act (NHPA), and Executive Order 13175 (“Consultation and Coordination with Tribal Governments”).
43 U.S.C. 1337(p)(3) states that “the Secretary shall issue a lease, easement, or right-of-way . . . on a competitive basis unless the Secretary determines after public notice of a proposed lease, easement, or right-of-way that there is no competitive interest.” Accordingly, BOEM must first determine whether there is competitive interest in acquiring a lease within the Call Area to develop offshore wind energy. At the conclusion of the comment period for this Call, BOEM will review the nominations received and determine if competitive interest exists in any of the call areas.
For areas with two or more valid nominations, BOEM may consider proceeding with competitive leasing as described in the section of this Call entitled, “Competitive Leasing Process.” For areas where BOEM determines that there is only one interested entity, BOEM may consider proceeding with noncompetitive leasing, as described in the section entitled “Noncompetitive Leasing Process.”
If BOEM determines that competitive interest exists and BOEM identifies those areas as appropriate to lease, BOEM may hold a competitive lease sale on any or all portions of the Call Area. In the event BOEM holds such a lease sale, all qualified bidders, including those bidders which did not submit a nomination in response to this Call, will be able to participate in the lease sale.
BOEM will not issue any leases until it has completed all required consultations and environmental analysis, which include the opportunity for public comment. Furthermore, BOEM reserves the right not to lease certain nominated areas, or modify such areas from their original, proposed form before offering them for lease.
BOEM will follow the steps required by 30 CFR 585.211 through 585.225 if it decides to proceed with the competitive leasing process for any areas after receiving responses and nominations for this Call.
(1)
(2)
(3)
(4)
(5)
BOEM's noncompetitive leasing process would include the following steps:
(1)
(2)
(3)
BOEM delineated the Call Areas in consultation with several parties, including the State of California and the Task Force. In coordination with the State of California, BOEM held multiple stakeholder outreach meetings in northern and central California to obtain input into the development of the Call Areas and gather data and information to use in BOEM's decision making process. More information on these meetings can be found in this notice under “Offshore Wind Energy Planning Efforts in California.” The Call Areas represent portions of the OCS that BOEM has identified to solicit information and nominations so that potential use conflicts can be analyzed and considered in the Area ID stage of the leasing process. During the process of delineating the California Call Areas, BOEM determined that the following areas would not be appropriate for leasing and development at this time:
1.
2.
3.
4.
5.
6.
Conversely, BOEM gave preference to areas within close proximity to existing transmission infrastructure that could provide for potential integration into California's existing electrical grid. These are, on the north coast, Humboldt Bay substation, and on the central coast, Morro Bay and Diablo Canyon substations. Transmission infrastructure information is available online at:
BOEM also endeavored to exclude from Call Areas those places where preliminary analysis indicated the presence of high concentrations of marine mammal and avian species potentially impacted by offshore wind development. These preliminary analyses were based on data found online at:
BOEM's subsequent analysis during Area Identification will evaluate the Call Areas for their appropriateness for offshore wind development, balanced against potential ocean user conflicts. After conducting environmental reviews and associated consultations, analyzing public comments, and continuing to coordinate with other government agencies through the Task Force, BOEM anticipates developing and requiring terms and conditions at the leasing, site assessment, and/or construction and operations phases of its leasing process to avoid or lessen impacts. This Call will allow stakeholders to provide additional input on these areas prior to further modification during the Area Identification process.
The Department of Defense (DoD) conducts offshore testing, training, and operations within all or portions of the Call Areas. BOEM is working with DoD to determine potential compatible areas or mitigating measures between military activities and offshore wind development areas. While conflicting uses may require some areas of the OCS to be deferred from leasing, development in other areas where military activities occur may eventually be compatible with conditions and stipulations. These stipulations could include, but may not be limited to: Hold and save harmless agreements; mandatory coordination with DoD on specified activities; restrictions on electromagnetic emissions; curtailment of wind farm operations during specific DoD events; and evacuation procedures from the lease area for safety reasons when notified by the DoD. Interested parties should also be aware that the Morro Bay and Diablo Canyon Call Areas on the central coast contain OCS blocks that have been assessed as incompatible with wind energy development by DoD. DoD is currently reviewing additional detailed project information supplied by the offshore wind energy industry to determine if any of the areas previously identified by DoD as incompatible in the Morro Bay Call Area may be identified as compatible after further analyses. The Diablo Canyon area is heavily utilized by multiple DoD components and based upon current and future expected use, previous assessments have found development there to be incompatible with the wide array of critical DoD activities. The Humboldt Call Area on the north coast is currently designated as “Site-Specific Stipulations” by DoD. This designation means DoD may recommend additional mitigation measures, but does not presently deem offshore wind to be incompatible with its missions.
The Humboldt, Morro Bay, and Diablo Canyon. These Call Areas include 85 whole OCS blocks and 573 partial blocks in total, and comprise approximately 1,073 square statute miles (mi) (687,823 acres). A map of the Call Areas, and associated GIS files, which are located in UTM Zone 10N, NAD 83 Datum, can be found at the following URL:
The boundary of Call Area Humboldt begins at 21 mi offshore the city of Eureka in northern California. The area is about 28 mi in length from north to south and about 14 mi in width from east to west. The entire area is approximately 206 square mi (132,369 acres) and is described in the table below:
The boundary of Call Area Morro Bay begins 24 mi offshore Cambria, California. The area is about 27 mi in length from north to south and about 27 mi in width from east to west. The entire area is approximately 311 square mi (199,266 acres) and is described in the table below:
The boundary of Call Area Diablo Canyon begins 22 mi offshore Los Osos, California. The area is about 23 mi in length from north to south and about 30 mi in width from east to west. The entire area is approximately 556 square mi (356,188 acres) and is described in the table below:
BOEM requests specific and detailed comments from the public and other interested or affected parties regarding the following features, activities, or concerns in or around Call Areas:
1. Geological, geophysical, and biological conditions (including bottom and shallow hazards and live bottom).
2. Known archaeological and/or cultural resource sites on the seabed.
3. Historic properties potentially affected by site characterization (surveys), site assessment (buoy installation), or commercial wind development. This information will inform BOEM's review of future undertakings under Section 106 of the NHPA and under NEPA.
4. Other uses, including navigation (in particular, commercial and recreational vessel use), recreation, and fisheries (commercial and recreational).
5. Additional information regarding recreational and commercial fisheries including, but not limited to, the use of the areas, the fishing gear types used, seasonal use, and recommendations for reducing use conflicts.
6. Available and pertinent data and information concerning renewable energy resources and environmental conditions. Where applicable, spatial information should be submitted in a format compatible with ArcGIS 10.5 in a geographic coordinate system (NAD 83).
7. Information relating to visual resources and aesthetics, the potential impacts of wind turbines to those resources, and potential strategies to help mitigate or minimize any visual effects.
8. Other relevant socioeconomic, biological, and environmental information.
9. Any other relevant information BOEM should consider during its planning and decision-making process for the purpose of issuing leases in the Call Area.
If you intend to submit one or more nominations for a commercial wind energy lease within any Call Areas identified in this notice, you must provide the following information for each nomination:
1. The BOEM Protraction name, number, and specific whole or partial OCS blocks within the Call Area(s) that you are interested in leasing, inclusive of any potential buffers with adjacent leases. This information should be submitted as a spatial file compatible with ArcGIS 10.5 in a geographic coordinate system (NAD 83) in addition to your hard copy submittal. If your nomination includes one or more partial blocks, please describe those partial blocks in terms of a sixteenth (
2. A description of your objectives and the facilities that you would use to achieve those objectives.
3. A preliminary schedule of proposed activities, including those leading to commercial operations.
4. Available and pertinent data and information concerning renewable energy resources and environmental conditions in the area(s) that you wish to lease, including energy and resource data and information used to evaluate the area. Where applicable, spatial information should be submitted in a format compatible with ArcGIS 10.5 in a geographic coordinate system (NAD 83).
5. Documentation demonstrating that you are legally qualified to hold a lease in accordance with the requirements of forth in 30 CFR 585.106 and 585.107(c). Examples of the documentation appropriate for demonstrating your legal qualifications and related guidance can be found in Chapter 2 and Appendix B of the
6. Documentation demonstrating that you are technically and financially capable of constructing, operating, maintaining, and decommissioning the facilities described in (2) above, in accordance with the requirements of 30 CFR 585.107(a). Guidance regarding the documentation to demonstrate your technical and financial qualifications can be found at:
You are not required to submit a nomination in response to this Call in order to participate in a potential future competitive lease sale offshore California. You will not be able to participate in such a competitive lease sale, however, unless you demonstrate prior to the sale that you are legally, technically, and financially qualified to hold a BOEM renewable energy lease. To ensure that BOEM has sufficient time to process your qualifications package, you should submit this package during the PSN 60-day public comment period. More information can be found at:
BOEM will not disclose privileged or confidential information that you submit if it qualifies for when required by the Freedom of Information Act (FOIA) exemption for trade secrets and commercial or financial information provided that you clearly label the submission with “Contains Confidential Information” and request that BOEM treat it as confidential. Please consider submitting such information as a separate attachment.
BOEM will not treat as confidential any aggregate summaries of such information or comments not containing such confidential or privileged information. Additionally, BOEM will not treat as confidential (1) the legal title of the nominating entity (for example,
BOEM does not consider anonymous comments; please include your name and address as part of your submittal. You should be aware that your entire comment, including your name, address, and your personal identifying information, may be made publicly available at any time. All submissions from identified individuals, businesses and organizations will be available for public viewing on
BOEM is required, after consultation with the Secretary, to withhold the location, character, or ownership of historic resources if it determines that disclosure may, among other things, risk harm to the historic resources or impede the use of a traditional religious site by practitioners. Tribal entities should designate information that falls under Section 304 of NHPA as confidential.
Bureau of Ocean Energy Management, Interior.
Notice of intent to prepare an Environmental Impact Statement.
Consistent with the regulations implementing the National Environmental Policy Act (NEPA), the Bureau of Ocean Energy Management (BOEM) is announcing its intent to prepare an Environmental Impact Statement (EIS) for the review of a Construction and Operations Plan (COP) submitted by Deepwater Wind South Fork, LLC (DWSF) that would allow it to construct and operate up to 15 turbines, an electric service platform offshore Rhode Island and Massachusetts and an export cable to East Hampton, New York. This Notice of Intent (NOI) serves to announce the EIS scoping process for the DWSF COP. Detailed information about the proposed wind energy facility, including the COP, can be found on BOEM's website at:
Comments should be submitted no later than November 19, 2018.
For information on the DWSF COP EIS, the submission of comments, or BOEM's policies associated with this notice, please contact Michelle Morin, BOEM Office of Renewable Energy Programs, 45600 Woodland Road, Sterling, Virginia 20166, (703) 787-1340 or
Once BOEM completes the EIS and associated consultations, BOEM will decide whether to approve, approve with modification, or disapprove the DWSF COP. If BOEM approves the COP and the proposed facility is constructed, the lessee must submit a plan to decommission the facilities before the end of the lease term.
Pursuant to the regulations implementing NEPA (42 U.S.C. 4321
• Amagansett, New York: Monday, November 5, 2018; American Legion Post 419, 15 Montauk Highway (across from Brent's), Amagansett, New York 11930; Open House 5:00-8:00 p.m.; Presentation and Q&A 6:00 p.m.
• New Bedford, Massachusetts: Wednesday, November 7, 2018; University of Massachusetts Dartmouth School for Marine Science and Technology East, 836 South Rodney French Boulevard, New Bedford, Massachusetts 02744; Open House 5:00-8:00 p.m.; Presentation and Q&A 6:00 p.m.
• Narragansett, Rhode Island: Thursday, November 8, 2018; Narragansett Community Center, 53 Mumford Road, Narragansett, Rhode Island 02882; Open House 5:00-8:00 p.m.; Presentation and Q&A 6:00 p.m.
Even if a governmental entity is not a cooperating agency, it will have opportunities to provide information and comments to BOEM during the public input stages of the NEPA process.
1. In written form, delivered by hand or by mail, enclosed in an envelope labeled, “Deepwater Wind South Fork COP EIS” and addressed to Program Manager, Office of Renewable Energy, Bureau of Ocean Energy Management, 45600 Woodland Road, Sterling, Virginia 20166. Comments must be received or postmarked no later than November 19, 2018; or
2. Through the
BOEM does not consider anonymous comments. Please include your name and address as part of your submittal. BOEM makes all comments, including the names and addresses of respondents, available for public review online and during regular business hours. Individual respondents may request that BOEM withhold their names or addresses from the public record; however, BOEM cannot guarantee that it will be able to do so. If you wish your name or address to be withheld, you must state your preference prominently at the beginning of your comment. All submissions from organizations or businesses and from individuals identifying themselves as representatives or officials of organizations or businesses will be made available for public inspection in their entirety.
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on September 14, 2018, under section 337 of the Tariff Act of 1930, as amended, on behalf of INVT SPE LLC of San Francisco, California. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain LTE- and 3G-compliant cellular communications devices by reason of infringement of certain claims of U.S. Patent No. 6,760,590 (“the ’590 patent”); U.S. Patent No. 7,206,587 (“the ’587 patent”); U.S. Patent No. 7,764,711 (“the ’711 patent”); U.S. Patent No. 7,848,439 (“the ’439 patent”); and U.S. Patent No. 7,339,949 (“the ’949 patent”). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute.
The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
The complaint, except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW, Room 112, Washington, DC 20436, telephone (202) 205-2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at
Pathenia M. Proctor, The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560.
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain products identified in paragraph (2) by reason of infringement of one or more of claims 3 and 4 of the ’590 patent; claim 4 of the ’587 patent; claims 1, 2, and 4 of the ’711 patent; claims 1-3 of the ’439 patent; and claim 16 of the ’949 patent; and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2) Pursuant to section 210.10(b)(1) of the Commission's Rules of Practice and Procedure, 19 CFR 210.10(b)(1), the plain language description of the accused products or category of accused products, which defines the scope of the investigation, is “personal electronic devices that are compliant with the LTE and/or 3G 3GPP specifications, and which enable LTE and/or 3G data transfer and communications”;
(3) Pursuant to Commission Rule 210.50(b)(1), 19 CFR 210.50(b)(1), the presiding administrative law judge shall take evidence or other information and hear arguments from the parties and other interested persons with respect to
(4) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainant is:
(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:
(c) The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and
(5) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.
Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
Notice is hereby given that, on September 10, 2018, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Pursuant to Section 6(b) of the Act, the identities of the parties to the venture are: Altius Space Machines, Inc., Broomfield, CO; Analytical Graphics, Inc., Exton, PA; Astroscale PTE. LTD., Tokyo, JAPAN; Ball Aerospace and Technology Corp., Boulder, CO; Chandah Space Technologies, Houston, TX; Hoffer Flow Controls, Inc. Elizabeth City, NC; iBOSS gmbH, Aachen, GERMANY; MacDonald, Dettwiler and Associates, Inc., Brampton, Ontario, CANADA; Thales Alenia Space, Courbevioe, FRANCE; The Aerospace Corporation, El Segundo, CA; and XL Catlin, LLC, New York, NY.
The general area of CONFERS' planned activity is to establish an independent, self-sustaining industry forum to advocate and promote on-orbit satellite maintenance, servicing, and rendezvous operations by collaborating to research, develop, and publish voluntary, consensus technical and safety standards, and engaging with governments on policy and oversight of satellite servicing activities. To fulfill its mission, CONFERS will recruit a broad array of members from satellite operators, service providers, insurers and underwriters, and engage other stakeholders from industry, academia, and governments. The process will be fully collaborative and will include dedicated outreach activities to engage the global commercial satellite community. The members of the CONFERS believe that future standards should be based on a set of guiding principles that will help establish responsible norms of behavior.
Notice of registration.
The registrant listed below has applied for and been granted registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of various classes of schedule I and II controlled substances.
The company listed below applied to be registered as a bulk manufacturer of various basic classes of controlled substances. Information on a previously published notice is listed in the table below. No comments or objections were submitted for this notice.
The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of this registrant to manufacture the applicable basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.
Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed company.
Notice of registration.
Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as importers of various classes of schedule I or II controlled substances.
The companies listed below applied to be registered as importers of various basic classes of controlled substances. Information on previously published notices are listed in the table below. No comments or objections were submitted and no requests for hearings were submitted for these notices.
The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of the listed registrants to import the applicable basic classes of schedule I or II controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated each company's maintenance of effective controls against diversion by inspecting and testing each company's physical security systems, verifying each company's compliance with state and local laws, and reviewing each company's background and history.
Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the DEA has granted a registration as an importer for schedule I or II controlled substances to the above listed companies.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before November 19, 2018. Such persons may also file a written request for a hearing on the application on or before November 19, 2018.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearings should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417, (January 25, 2007).
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on July 4, 2018, Noramco Inc., 1550 Olympic Drive, Athens, Georgia 30601 applied to be registered as an importer of the following basic classes of controlled substances:
The company plans to import phenylacetone (8501), and poppy straw concentrate (9670) to bulk manufacture other controlled substances for distribution to its customers. The company plans to import an intermediate form of tapentadol (9780) to bulk manufacture tapentadol (9780) for distribution to its customers.
The company plans to import impunities of buprenorphine that have been determined by DEA to be captured under drug code (9333) thebaine.
In reference to drug codes 7360 and 7370, the company plans to import a synthetic cannabidiol and a synthetic tetrahydrocannabinol. No other activity for these drug codes is authorized for this registration. Placement of these drug codes onto the company's registration does not translate into automatic approval of subsequent permit applications to import controlled substances. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before November 19, 2018. Such persons may also file a written request for a hearing on the application on or before November 19, 2018.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on June 4, 2018, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown, Pennsylvania 18106 applied to be registered as an importer of the following basic class of controlled substance:
The company plans to import the listed controlled substance for clinical trials.
Bureau of Justice Statistics, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 30 days until November 19, 2018.
If you have additional comments especially on the estimated public burden or associated response time,
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1)
(2)
(3)
(4)
(5)
(6)
Bureau of Justice Statistics, Office of Justice Programs, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for 30 days until November 19, 2018.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Anthony S. Whyde, Statistician, Law Enforcement Statistics Unit, Bureau of Justice Statistics, 810 Seventh Street NW, Washington, DC 20531 (email:
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1)
(2)
(3)
(4)
(5)
(6)
Bureau of Justice Statistics, Office of Justice Programs, Department of Justice.
30-Day notice.
Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 day until November 19, 2018.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Suzanne M. Strong, Statistician, Bureau of Justice Statistics, 810 Seventh Street NW, Washington, DC 20531 (email:
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1)
(2)
(3)
(4)
(6)
Notice.
The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995. The program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Office of Federal Contract Compliance Programs (OFCCP) is soliciting comments concerning its proposal to obtain approval from the Office of Management and Budget (OMB) to implement the Leadership in Equal Access and Diversity (LEAD) award. OFCCP will be sharing the information with DOL's Women's Bureau for the purpose of partnering with them in support of the award. A copy of the proposed information collection request can be obtained by contacting the office listed below in the
Written comments must be submitted to the office listed in the addresses section below on or before December 18, 2018.
You may submit comments by any of the following methods:
Harvey D. Fort, Acting Director, Division of Policy and Program Development, Office of Federal Contract Compliance Programs, Room C-3325, 200 Constitution Avenue NW, Washington, DC 20210. Telephone: (202) 693-0103 (voice) or (202) 693-1337 (TTY) (these are not toll-free numbers). Copies of this notice may be obtained in alternative formats (large print, braille, audio recording) upon request by calling the numbers listed above.
OFCCP administers and enforces the three nondiscrimination and equal employment opportunity laws listed below.
• Executive Order 11246, as amended (E.O. 11246)
• Section 503 of the Rehabilitation Act of 1973, as amended (Section 503)
• Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended (VEVRAA)
These authorities prohibit employment discrimination by covered federal contractors and subcontractors and require that they provide equal employment opportunities regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Additionally, federal contractors and subcontractors are prohibited from discriminating against applicants and employees for asking about, discussing, or sharing information about their pay or the pay of their co-workers. E.O. 11246 applies to federal contractors and subcontractors and to federally assisted construction contractors holding a Government contract in excess of $10,000, or Government contracts that have, or can reasonably be expected to have, an aggregate total value exceeding $10,000 in a 12-month period. E.O. 11246 also applies to government bills of lading, depositories of federal funds in any amount, and to financial institutions that are issuing and paying agents for U.S. Savings Bonds. Section 503 prohibits employment discrimination against applicants and employees because of physical or mental disability and requires affirmative action to ensure that persons are treated without regard to disability. Section 503 applies to federal contractors and subcontractors with contracts in excess of $15,000. VEVRAA prohibits employment discrimination against protected veterans and requires affirmative action to ensure that persons are treated without regard to their status as a protected veteran. VEVRAA applies to federal contractors and subcontractors with contracts of $150,000 or more. This collection will implement the LEAD award that will recognize federal contractor and subcontractor establishments that have developed and successfully implemented comprehensive equal employment opportunity and nondiscrimination programs.
OFCCP is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the compliance assistance functions of the agency that support the agency's compliance mission, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
OFCCP seeks approval of this new information collection in order to carry out and enhance its responsibilities to enforce the nondiscrimination and affirmative action provisions of the three legal authorities it administers.
Mine Safety and Health Administration, Labor.
Notice.
This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by the party listed below.
All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before November 19, 2018.
You may submit your comments, identified by “docket number” on the subject line, by any of the following methods:
1.
2.
3.
MSHA will consider only comments postmarked by the U.S. Postal Service or proof of delivery from another delivery service such as UPS or Federal Express on or before the deadline for comments.
Barbara Barron, Office of Standards, Regulations, and Variances at 202-693-9447 (voice),
Section 101(c) of the Federal Mine Safety and Health Act of 1977 and Title 30 of the Code of Federal Regulations Part 44 govern the application, processing, and disposition of petitions for modification.
Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor (Secretary) determines that:
1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or
2. That the application of such standard to such mine will result in a diminution of safety to the miners in such mine.
In addition, the regulations at 30 CFR 44.10 and 44.11 establish the requirements and procedures for filing petitions for modification.
The petitioner states that:
(1) The alternative method provides a direct reduction of miners' exposure to respirable dust, thus reducing their health risks. The proposed alternative method has been jointly developed between Unimin Corporation and the National Institute of Occupational Safety and Health (NIOSH) and successfully tested by the NIOSH.
(2) The petition proposes the following:
The petitioner asserts that the proposed alternative method will at all times guarantee no less than the same measure of protection afforded by the standard.
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Aeronautics Committee of the NASA Advisory Council (NAC). This meeting will be held for soliciting, from the aeronautics community and other persons, research and technical information relevant to program planning.
Thursday, November 15, 2018, 10:30 a.m.-5:30 p.m., Local Time.
NASA Langley Research Center, 2 Langley Boulevard, Building 2101, Room 305, Hampton, VA 23681.
Ms. Irma Rodriguez, Designated Federal Officer, Aeronautics Research Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-0984, or
The meeting will be open to the public up to the capacity of the room. This meeting is also available telephonically and by WebEx. You must use a touch-tone telephone to participate in this meeting. Any interested person may dial the USA toll-free conference number 1-888-769-8716, participant passcode: 6813159, followed by the # sign to participate in this meeting by telephone. The WebEx link is
For NASA Langley Research Center visitor access, please go through the Main Gate and show a valid government-issued identification (
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Human Exploration and Operations Research Advisory Committee.
November 16, 2018, 9:00 a.m. to 5:00 p.m., Local Time.
NASA Headquarters, Room 7H41, 300 E Street SW, Washington, DC 20546.
Dr. Bradley Carpenter, Designated Federal Officer, Human Exploration and Operations Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-0826, or
The meeting will be open to the public up to the capacity of the room. This meeting is also available telephonically and by WebEx. Any interested person may dial the USA toll free conference call number 1-844-467-6272 or toll number 1-720-259-6462, participant passcode: 535959, followed by the # sign, to participate in this meeting by telephone. The WebEx link is
The agenda for the meeting includes the following topics:
Attendees will be requested to sign a register and to comply with NASA security requirements, including the presentation of a valid picture ID to Security before access to NASA Headquarters. Foreign nationals attending this meeting will be required to provide a copy of their passport and visa in addition to providing the following information no less than 10 working days prior to the meeting: Full name; gender; date/place of birth; citizenship; visa information (number, type, expiration date); passport information (number, country, expiration date); employer/affiliation information (name of institution, address, country, telephone); title/position of attendee; and home address to Dr. Bradley Carpenter via email at
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
National Science Foundation.
Notice.
The National Science Foundation is announcing the members of the Senior Executive Service Performance Review Board.
Comments should be addressed to Branch Chief, Executive Services, Division of Human Resource Management, National Science Foundation, Room W15219, 2415 Eisenhower Avenue, Alexandria, VA 22314.
Ms. Jennifer Munz at the above address or (703) 292-2478.
The membership of the National Science Foundation's Senior Executive Service Performance Review Board is as follows:
This announcement of the membership of the National Science Foundation's Senior Executive Service Performance Review Board is made in compliance with 5 U.S.C. 4314(c)(4).
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended),
Nuclear Regulatory Commission.
Environmental impact statement; extension of comment period.
On September 4, 2018, the U.S. Nuclear Regulatory Commission (NRC) published in the
The due date of comments requested in the document published on September 4, 2018 (83 FR 44922), is extended. Comments should be filed no later than November 19, 2018. Comments received after this date will be considered, if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.
You may submit comments by any of the following methods:
•
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
James Park, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-6954; email:
Please refer to Docket ID NRC-2016-0231 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
•
•
•
•
Please include Docket ID NRC-2016-0231 in your comment submission. Comments received during this extended scoping period will be considered by the NRC in determining the scope of the EIS. Scoping comments submitted previously need not be resubmitted during this extended scoping period.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
On April 28, 2016, WCS submitted a license application to NRC for a proposed CISF for spent nuclear fuel. The NRC accepted the WCS application for detailed review on January 26, 2017. On November 14, 2016 (81 FR 79531), the NRC opened the public scoping period for its EIS on the WCS license application. On April 18, 2017, WCS requested that NRC temporarily suspend its review. The EIS public scoping comment period closed on April 28, 2017.
On June 8, 2018, ISP (a joint venture between WCS and Orano CIS LLC) requested that NRC resume its detailed review and submitted a revised CISF license application. On July 19, 2018, ISP provided an update to its application. On September 4, 2018 (83 FR 44922), the NRC reopened the scoping period for its EIS, with comments to be submitted by October 19, 2018.
The NRC is extending the public comment scoping period to November 19, 2018.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Direct and indirect transfer of license; order.
The U.S. Nuclear Regulatory Commission (NRC) is issuing an order approving the direct transfer of Renewed Facility Operating License No. DPR-28 for the Vermont Yankee Nuclear Power Station (VY), and its general license for the VY Independent Spent Fuel Storage Installation (ISFSI), from the currently licensed operator, Entergy Nuclear Operations, Inc. (ENOI), and currently licensed owner, Entergy Nuclear Vermont Yankee, LLC (ENVY), to NorthStar Nuclear Decommissioning Company, LLC (NorthStar NDC), and to ENVY's successor NorthStar Vermont Yankee, LLC (NorthStar VY). This order also approves the indirect transfer of control of the license from ENVY's Entergy parent holding and investment companies to NorthStar Decommissioning Holdings, LLC and its parents NorthStar Group Services, Inc. (NorthStar), LVI Parent Corp., and NorthStar Group Holdings, LLC. The NRC is also issuing a conforming amendment for the facility operating license for administrative purposes to reflect the approved license transfer.
The NRC confirmed that NorthStar NDC, and the entity to be named NorthStar VY, met the regulatory, legal, technical, and financial obligations necessary to qualify them as a transferee and determined that the transferee is qualified to be the holder of the license; and the transfer of the license is otherwise consistent with the applicable provisions of law, regulations, and orders issued by the Commission. The Order approving the direct transfer of the VY license to NorthStar NDC and NorthStar VY and the indirect transfer to NorthStar Decommissioning Holdings, LLC and its parents became effective on October 11, 2018.
The Order was issued on October 11, 2018, and is effective for one year.
Please refer to Docket ID NRC-2018-0216 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
•
•
•
Jack D. Parrott, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-6634, email:
The text of the Order is attached.
For the Nuclear Regulatory Commission.
Entergy Nuclear Operations, Inc. (ENOI), on behalf of itself and Entergy Nuclear Vermont Yankee, LLC (ENVY), are the holders of Renewed Facility Operating License No. DPR-28, which authorizes the operation of the Vermont Yankee Nuclear Power Station (VY), and the general license for the VY Independent Spent Fuel Storage Installation (ISFSI). VY permanently ceased operations on December 29, 2014. Pursuant to Sections 50.82(a)(1)(i) and (a)(1)(ii) of Title 10 of the
By letter dated February 9, 2017 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML17045A140), and as supplemented by letters dated April 6, 2017 (ADAMS Accession No. ML17096A394), August 22, 2017 (ADAMS Accession No. ML17234A141), August 28, 2017 (ADAMS Accession No. ML17248A468), December 4, 2017 (ADAMS Accession No. ML17339A896), December 22, 2017 (ADAMS Accession No. ML18009A459), May 21, 2018 (ADAMS Accession No. ML18143B484), and June 28, 2018 (ADAMS Accession No. ML18183A220), ENOI, on behalf of itself and ENVY, and NorthStar Nuclear Decommissioning Company, LLC (NorthStar NDC) (together, the Applicants), requested that the U.S. Nuclear Regulatory Commission (NRC) consent to the proposed direct and indirect transfer of the VY Renewed Facility Operating License No. DPR-28 and the general license for the VY ISFSI (collectively referred to as the facility). Specifically, the Applicants requested that the NRC consent to the direct transfer of ENOI's currently licensed authority (licensed operator for decommissioning) to NorthStar NDC. In addition, the Applicants requested the indirect transfer of control of ENVY's ownership interests in the facility licenses to NorthStar Decommissioning Holdings, LLC, and its parents NorthStar Group Services, Inc. (NorthStar), LVI Parent Corp. (LVI) and NorthStar Group Holdings, LLC (Holdings). These direct and indirect transfer requests are submitted to the NRC for approval pursuant to Section 184 of the Atomic Energy Act of 1954, as amended (AEA), “Inalienability of Licenses,” and 10 CFR 50.80, “Transfer of licenses,” 10 CFR 72.50, “Transfer of licenses,” and 10 CFR 50.90, “Application for amendment of license, construction permit, or early site permit.” The supplemental information letters, listed above, contained clarifying information, did not expand the application beyond the scope of the original notice, and did not affect the applicability of the NRC's no significant hazards consideration determination.
ENOI and ENVY intend to transfer the licensed possession, maintenance, and decommissioning authorities to NorthStar NDC in order to implement expedited decommissioning at VY. Following approval and implementation of the proposed direct transfer of control of the license, NorthStar NDC would assume licensed responsibility for VY through the direct transfer of ENOI's responsibility for licensed activities at VY to NorthStar NDC. If the proposed indirect transfer of control is approved, ENVY would change its name to NorthStar VY, but the same legal entity would continue to exist before and after the proposed transfer. NorthStar VY would also enter into an operating agreement with NorthStar NDC, which provides for NorthStar NDC to act as NorthStar VY's agent and for NorthStar VY to pay NorthStar NDC's costs of operation, including all decommissioning costs. NorthStar VY would own the VY facility as well as its associated assets and real estate, including its nuclear decommissioning trust fund, title to spent nuclear fuel, and rights pursuant to the terms of its Standard Contract for Disposal of Spent Nuclear Fuel and/or High-Level Radioactive Waste with the U.S. Department of Energy. Certain off-site assets and real estate of ENVY are excluded, such as administrative offices and off-site training facilities. Upon the proposed license transfer, NorthStar NDC would assume responsibility for compliance with the current licensing basis, including regulatory commitments that exist at the closing of the transaction between the Applicants, and would implement any changes under applicable regulatory requirements and practices. The Applicants also requested that the NRC approve a conforming administrative amendment to the facility license to reflect the proposed direct transfer of the license from ENOI to NorthStar NDC as well as a planned name change for ENVY from ENVY to NorthStar VY.
Notice of NRC consideration of the license transfer application was published in the
The staff notes, by letter dated May 25, 2018 (ADAMS Accession No. ML18150A315), in support of the license transfer request, that NorthStar submitted a request for an exemption to 10 CFR 50.82(a)(8)(i)(A) to use up to $20 million of the VY trust (on a revolving basis) to pay for spent fuel management expenses. The staff approved the exemption request on October 11, 2018 (ADAMS Accession No. ML18274A246). The exemption is being issued simultaneously with this Order.
Pursuant to 10 CFR 50.80, no license for a production or utilization facility, or any right thereunder, shall be transferred, either voluntarily or involuntarily, directly or indirectly, through transfer of control of the license to any person, unless the Commission gives its consent in writing. Upon review of the information in the application and other information before the Commission, and relying upon the representations and agreements contained in the application, the NRC staff has determined that NorthStar VY and NorthStar NDC are qualified to be the holders of the licenses, and that the direct and indirect transfer of the licenses, as described in the application, is otherwise consistent with applicable provisions of law, regulations, and orders issued by the Commission pursuant thereto, subject to the condition set forth below.
Upon review of the application for a conforming amendment to the VY license to reflect the direct and indirect transfer of the VY licenses, the NRC staff determined the following:
(1) The application for the proposed license amendment complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations set forth in 10 CFR Chapter I.
(2) There is reasonable assurance that the activities authorized by the proposed license amendment can be conducted without endangering the health and safety of the
(3) The issuance of the proposed license amendment will not be inimical to the common defense and security or to the health and safety of the public.
(4) The issuance of the proposed license amendment is in accordance with 10 CFR part 51 of the Commission's regulations, and all applicable requirements have been satisfied.
The findings set forth above are supported by an NRC safety evaluation dated October 11, 2018, which is available at ADAMS Accession No. ML18242A639.
Accordingly, pursuant to Sections 161b, 161i, 161o, and 184 of the AEA, 42 U.S.C. Sections 2201(b), 2201(i), 2201(o), and 2234; and 10 CFR 50.80, 10 CFR 72.50, and 10 CFR 50.90, IT IS HEREBY ORDERED that the application for the direct and indirect transfer of the licenses, as described herein is approved for Vermont Yankee Nuclear Power Station and the ISFSI, subject to the following conditions:
(1) Prior to the closing of the license transfer, NorthStar NDC and NorthStar VY shall provide the Directors of NRC's Office of Nuclear Material Safety and Safeguards (NMSS) and Office of Nuclear Reactor Regulation (NRR) satisfactory documentary evidence that they have obtained the appropriate amount of insurance required of a licensee under 10 CFR 140.11(a)(4) and 10 CFR 50.54(w) of the Commission's regulations, consistent with the exemptions issued to VY on April 15, 2016.
(2) NorthStar Vermont Yankee, LLC and NorthStar Nuclear Decommissioning Company, LLC shall take no action to cause NorthStar Group Services, Inc., to void, cancel, or modify the $140 million Support agreement to provide funding for Vermont Yankee as represented in the application without prior written consent of the Director of the Office of Nuclear Reactor Regulation.
(3) NorthStar Vermont Yankee, LLC shall obtain a performance bond if a Settlement Agreement with the U.S. Department of Energy (DOE), on DOE reimbursements for spent fuel management expenses, is not entered into by January 1, 2022. The performance bond will be effective January 1, 2022, initially in the amount of $4.3 million, and it will be renewed annually. This amount covers the annual amount of Independent Spent Fuel Storage Installation (ISFSI) operation and maintenance (O&M) costs projected for 2022-2024. If a settlement is not reached by January 1, 2024, this amount will be increased to $9.3 million, which covers the annual amount of ISFSI O&M costs projected for years after 2024.
IT IS FURTHER ORDERED that, consistent with 10 CFR 2.1315(b), the license amendment that makes changes, as indicated in Enclosure 2 to the cover letter forwarding this Order, to conform the license to reflect the subject direct and indirect license transfer, is approved. The amendment shall be issued and made effective within 30 days of the date of when the proposed direct and indirect license transfer action is completed.
IT IS FURTHER ORDERED that NorthStar NDC and NorthStar VY shall, at least 2 business days prior to closing, inform the Directors of NMSS and NRR in writing of the date of closing of the license transfer for VY and the ISFSI. Should the transfer of the license not be completed within 1 year of this Order's date of issuance, this Order shall become null and void; provided, however, that upon written application and for good cause shown, such date may be extended by order.
This Order is effective upon issuance.
For further details with respect to this Order, see the initial application dated February 9, 2017, as supplemented by letters dated April 6, 2017, August 22, 2017, August 28, 2017, December 4, 2017, December 22, 2017, May 21, 2018, and June 28, 2018, and the associated NRC safety evaluation dated October 11, 2018, which are available for public inspection at the Commission's Public Document Room (PDR), located at One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available documents are accessible electronically through ADAMS in the NRC Library at http://www.nrc.gov/reading-rm/adams.html. Persons who encounter problems with ADAMS should contact the NRC's PDR reference staff by telephone at 1-800-397-4209 or 301-415-4737 or by e-mail to
Dated at Rockville, Maryland this 11th day of October 2018.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Appointments.
The U.S. Nuclear Regulatory Commission (NRC) has announced appointments to the NRC Performance Review Board (PRB) responsible for making recommendations on performance appraisal ratings and performance awards for NRC Senior Executives and Senior Level System employees and appointments to the NRC PRB Panel responsible for making recommendations to the appointing and awarding authorities for NRC PRB members.
October 19, 2018.
Please refer to Docket ID NRC-2018-0219 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
•
•
•
Miriam L. Cohen, Secretary, Executive Resources Board, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-287-0747, email:
The following individuals appointed as members of the NRC PRB are responsible for making recommendations to the appointing and awarding authorities on performance appraisal ratings and performance awards for Senior Executives and Senior Level System employees:
The following individuals will serve as members of the NRC PRB Panel that was established to review appraisals and make recommendations to the appointing and awarding authorities for NRC PRB members:
All appointments are made pursuant to Section 4314 of Chapter 43 of Title 5 of the United States Code.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Application for direct transfer of license; opportunity to comment, request a hearing, and petition for leave to intervene.
The U.S. Nuclear Regulatory Commission (NRC) received and is considering approval of an application filed by Exelon Generation Company, LLC (Exelon), Oyster Creek Environmental Protection, LLC (OCEP), and Holtec Decommissioning International, LLC (HDI) on August 31, 2018. The application seeks NRC approval of the direct transfer of Renewed Facility Operating License No. DPR-16 for Oyster Creek Nuclear Generating Station (Oyster Creek), as well as the general license for the Oyster Creek Independent Spent Fuel Storage Installation (ISFSI), from the current holder, Exelon, to OCEP as the licensed owner and to HDI as the licensed operator. The NRC is also considering amending the renewed facility operating license and ISFSI general license for administrative purposes to reflect the proposed transfer. The application contains sensitive unclassified non-safeguards information (SUNSI).
Comments must be filed by November 19, 2018. A request for a hearing must be filed by November 8, 2018. Any potential party as defined in section 2.4 of title 10 of the
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
•
•
•
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
John G. Lamb, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-3100; email:
Please refer to Docket ID NRC-2018-0237 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
•
•
•
Please include Docket ID NRC-2018-0237 in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
The NRC is considering the issuance of an order under 10 CFR 50.80 and
Following approval of the proposed direct transfer of control of the license, OCEP would acquire ownership of the facility, and HDI would be responsible for the operation and maintenance of Oyster Creek in the permanently shutdown and defueled condition.
No physical changes to the Oyster Creek facility or operational changes are being proposed in the application.
The NRC's regulations at 10 CFR 50.80 state that no license, or any right thereunder, shall be transferred, directly or indirectly, through transfer of control of the license, unless the Commission gives its consent in writing. The Commission will approve an application for the direct transfer of a license if the Commission determines that the proposed transferee is qualified to hold the license, and that the transfer is otherwise consistent with applicable provisions of law, regulations, and orders issued by the Commission.
Before issuance of the proposed conforming license amendment, the Commission will have made findings required by the Atomic Energy Act of 1954, as amended (the Act), and the Commission's regulations.
As provided in 10 CFR 2.1315, unless otherwise determined by the Commission with regard to a specific application, the Commission has determined that any amendment to the license of a utilization facility or to the license of an ISFSI, which does no more than conform the license to reflect the transfer action involves no significant hazards consideration and no genuine issue as to whether the health and safety of the public will be significantly affected. No contrary determination has been made with respect to this specific license amendment application. In light of the generic determination reflected in 10 CFR 2.1315, no public comments with respect to significant hazards considerations are being solicited, notwithstanding the general comment procedures contained in 10 CFR 50.91.
Within 30 days from the date of publication of this notice, persons may submit written comments regarding the license transfer application, as provided for in 10 CFR 2.1305. The Commission will consider and, if appropriate, respond to these comments, but such comments will not otherwise constitute part of the decisional record. Comments should be submitted as described in the
Within 20 days after the date of publication of this notice, any persons (petitioner) whose interest may be affected by this action may file a request for a hearing and petition for leave to intervene (petition) with respect to the action. Petitions shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested persons should consult a current copy of 10 CFR 2.309. The NRC's regulations are accessible electronically from the NRC Library on the NRC's website at
As required by 10 CFR 2.309(d) the petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements for standing: (1) The name, address, and telephone number of the petitioner; (2) the nature of the petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the petitioner's interest.
In accordance with 10 CFR 2.309(f), the petition must also set forth the specific contentions which the petitioner seeks to have litigated in the proceeding. Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner must provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner must also provide references to the specific sources and documents on which the petitioner intends to rely to support its position on the issue. The petition must include sufficient information to show that a genuine dispute exists with the applicant or licensee on a material issue of law or fact. Contentions must be limited to matters within the scope of the proceeding. The contention must be one which, if proven, would entitle the petitioner to relief. A petitioner who fails to satisfy the requirements at 10 CFR 2.309(f) with respect to at least one contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene. Parties have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that party's admitted contentions, including the opportunity to present evidence, consistent with the NRC's regulations, policies, and procedures.
Petitions must be filed no later than 20 days from the date of publication of this notice. Petitions and motions for leave to file new or amended contentions that are filed after the deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i) through (iii). The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document.
A State, local governmental body, Federally-recognized Indian Tribe, or agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1). The petition should state the nature and extent of the petitioner's interest in the proceeding. The petition should be submitted to the Commission no later than 20 days from the date of publication of this notice. The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document, and should meet the requirements for petitions set forth in this section, except that under 10 CFR 2.309(h)(2), a State, local governmental body, or Federally-recognized Indian Tribe, or agency thereof does not need to address the standing requirements in 10 CFR 2.309(d) if the facility is located within its boundaries. Alternatively, a State, local governmental body, Federally-recognized Indian Tribe, or agency thereof may participate as a non-party under 10 CFR 2.315(c).
If a hearing is granted, any person who is not a party to the proceeding and is not affiliated with or represented by a party may, at the discretion of the presiding officer, be permitted to make
All documents filed in NRC adjudicatory proceedings, including a request for hearing and petition for leave to intervene (petition), any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities that request to participate under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007, as amended at 77 FR 46562; August 3, 2012). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Detailed guidance on making electronic submissions may be found in the Guidance for Electronic Submissions to the NRC and on the NRC website at
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
Information about applying for a digital ID certificate is available on the NRC's public website at
A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC's Electronic Filing Help Desk through the “Contact Us” link located on the NRC's public website at
Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing stating why there is good cause for not filing electronically and requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing adjudicatory documents in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at
The Commission will issue a notice or order granting or denying a hearing request or intervention petition, designating the issues for any hearing that will be held and designating the Presiding Officer. A notice granting a hearing will be published in the
For further details with respect to this application, see the application dated August 31, 2018.
Any person who desires access to proprietary, confidential commercial information that has been redacted from the application should contact the applicant by telephoning Tamara Domeyer, Associate General Counsel for Exelon, at 630-657-3753 for the purpose of negotiating a confidentiality agreement or a proposed protective order with the applicant. If no agreement can be reached, persons who desire access to this information may file a motion with the Secretary and addressed to the Commission that requests the issuance of a protective order.
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The October 23, 2018 comment due date applies to Docket Nos. MC2019-5 and CP2019-4; MC2019-6 and CP2019-5; MC2019-7 and CP2019-6; MC2019-8 and CP2019-7.
The October 24, 2018 comment due date applies to Docket Nos. MC2019-9 and CP2019-8; MC2019-10 and CP2019-9.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3010, and 39 CFR part 3020, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comment deadline(s) for each request appear in section II.
1.
2.
3.
4.
5.
6.
This Notice will be published in the
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on October 15, 2018, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on October 15, 2018, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on October 15, 2018, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on October 15, 2018, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on October 15, 2018, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on October 15, 2018, it filed with the Postal Regulatory Commission a
On June 27, 2018, The Nasdaq Stock Market LLC (“Nasdaq” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Commission previously approved the listing and trading of the Shares of the Fund.
The Exchange is proposing to: (i) Amend the definition of the term “under normal market conditions;” (ii) permit the Fund to invest a limited amount of its net assets in Senior Loans
The Prior Notice stated that the Fund, under normal market conditions, would seek to outperform the S&P/LSTA U.S. Leveraged Loan 100 Index (“Primary Index”) and the Markit iBoxx USD Liquid Leveraged Loan Index (“Secondary Index”) by investing at least 80% of its net assets (plus any borrowings for investment purposes) in Senior Loans. The Prior Notice defined “under normal market conditions” as follows:
The term “under normal market conditions” as used herein includes, but is not limited to, the absence of adverse market, economic, political or other conditions, including extreme volatility or trading halts in the fixed income markets or the financial markets generally; operational issues causing dissemination of inaccurate market information; or
The term “under normal market conditions” as used herein includes, but is not limited to, the absence of adverse market, economic, political or other conditions, including extreme volatility or trading halts in the fixed income markets or the financial markets generally; operational issues causing dissemination of inaccurate market information; or
In the Prior Notice, the Exchange represented that the Adviser does not intend to purchase Senior Loans that are in default, but the Fund may hold a Senior Loan that has defaulted subsequent to its purchase by the Fund. In discussing the Fund's other investments, the Exchange also represented that the Fund will not invest in floating rate loans of companies whose financial condition is troubled or uncertain and that have defaulted on current debt obligations, as measured at the time of investment.
The Exchange proposes to permit the Fund to invest a limited portion of its net assets in Senior Loans and other floating rate loans that are in default. As proposed, Defaulted Loans would comprise no more than 15% of the Fund's net assets, as determined at the time of purchase (“15% Limitation”). If, subsequent to being purchased or otherwise obtained by the Fund, a Senior Loan or other floating rate loan defaults, the Fund may continue to hold such Senior Loan or other floating rate loan without regard to the 15% Limitation; however, such Senior Loan or other floating rate loan would be considered a Defaulted Loan for purposes of determining whether the Fund's purchase of additional Defaulted Loans would comply with the 15% Limitation.
As described in the Prior Notice, the Fund may receive equity, warrants, corporate bonds and other such securities
The Exchange proposes to modify the Received Instruments Triggers to provide that the Fund may receive Received Instruments (i) in conjunction with the restructuring or reorganization, as applicable, of an issuer or any debt issued by an issuer, whether accomplished within or outside of a bankruptcy proceeding under 11 U.S.C. 101
The Prior Notice stated that except for investments in exchange-traded funds that may hold non-U.S. issues, the Fund would not otherwise invest in non-U.S. equity issues (“Non-U.S. Equity Restriction”). The Prior Notice also stated that the equity securities in which the Fund may invest would be limited to securities that trade in markets that are members of the ISG or are parties to a comprehensive surveillance sharing agreement with the Exchange (“ISG Restriction”).
The Exchange proposes to permit the Fund to retain, without regard to the Non-U.S. Equity Restriction or the ISG Restriction, Received Instruments that would encompass a broad range of U.S. and non-U.S. equity and equity-like positions and interests (“Equity-Based Received Instruments”). As proposed, Equity-Based Received Instruments means any one or more of the following (whether received individually or as part of a unit or package of securities and/or other instruments): (i) Common and preferred equity interests in corporations; (ii) membership interests (
In the Prior Notice, the Exchange represented that each of the Fund's Senior Loan investments was expected to have no less than $250 million par outstanding (“Par Amount
The Exchange proposes to permit the Fund to retain Received Instruments in its portfolio, without regard to the Par Amount Representation or the Convertible Securities Restriction.
After careful review, the Commission finds that the proposed rule change, as modified by Amendment No. 1, is consistent with the Act and the rules and regulations thereunder applicable to a national securities exchange.
The Commission believes that the proposed definition of “under normal market conditions” would provide flexibility under certain conditions where the Adviser may find that it is appropriate for the Fund to depart from its principal investment strategies, which could potentially help the Fund to mitigate risks that may accompany these conditions.
With respect to the aspect of the proposal that would permit the Fund to invest a portion of its net assets in Defaulted Loans, the Commission believes that the proposal would provide the Adviser with additional flexibility, but would be limited in scope. As discussed above, Defaulted Loans would be subject to the 15% Limitation. If, subsequent to being purchased or otherwise obtained by the Fund, a Senior Loan or other floating rate loan defaults, the Fund may continue to hold such Senior Loan or other floating rate loan without regard to the 15% Limitation; however, such Senior Loan or other floating rate loan would be considered a Defaulted Loan for purposes of determining whether the Fund's purchase of additional Defaulted Loans would comply with the 15% Limitation.
As discussed above, the Exchange also proposes to amend the Received Instruments Triggers and to permit the Fund to retain a limited amount of Received Instruments. The Commission notes that the Fund's ability to retain Received Instruments would be limited in scope. As discussed above, the Fund's aggregate holdings in (a) Received Instruments that are not Senior Loans and (b) Received Instruments that are Senior Loans and do not satisfy the Par Amount Representation would be limited to 20% of the Fund's net assets.
The Commission notes that the Exchange does not propose to change the Fund's investment objectives and, except as provided in the current proposal, all other representations made in the Prior Notice would remain unchanged. The Commission notes that, notwithstanding the proposed changes, the Exchange anticipates that the Fund, in accordance with its principal investment strategy, would continue to invest approximately 50% to 75% of its net assets in Senior Loans that are eligible for inclusion in and meet the liquidity thresholds of the Primary Index and/or the Secondary Index.
The Commission also finds that the proposal is consistent with Section 11A(a)(1)(C)(iii) of the Act,
On each business day, before commencement of trading in Shares in the Regular Market Session on the Exchange, the Fund would continue to disclose on
In support of this proposal, the Exchange also represents that trading in the Shares will be subject to the existing trading surveillances, administered by both the Exchange and the Financial Industry Regulatory Authority (“FINRA”) on behalf of the Exchange, which are designed to detect violations of Exchange rules and applicable federal securities laws,
The Exchange represents that all statements and representations made in the filing regarding (a) the description of the portfolio or reference assets, (b) limitations on portfolio holdings or reference assets, (c) dissemination and availability of the reference asset or intraday indicative values, or (d) the applicability of Exchange listing rules shall constitute continued listing requirements for listing the Shares on the Exchange. In addition, the issuer has represented to the Exchange that it will advise the Exchange of any failure by the Fund to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will monitor
This approval order is based on all of the Exchange's representations, including those set forth above and in Amendment No. 1.
For the foregoing reasons, the Commission finds that the proposed rule change, as modified by Amendment No. 1, is consistent with Section 6(b)(5) of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 15g-5 requires brokers and dealers to disclose to customers the amount of compensation to be received by their sales agents in connection with penny stock transactions. The purpose of the rule is to increase the level of disclosure to investors concerning penny stocks generally and specific penny stock transactions.
The Commission estimates that approximately 195 broker-dealers will spend an average of 87 hours annually to comply with the rule. Thus, the total compliance burden is approximately 16,965 burden-hours per year.
Rule 15g-5 contains record retention requirements. Compliance with the rule is mandatory.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following website:
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed rule change consists of amendments to (i) the Clearing Agency Policy on Capital Requirements (“Capital Policy” or “Policy”) of NSCC and its affiliates, The Depository Trust Company (“DTC”) and Fixed Income Clearing Corporation (“FICC,” and together with DTC and NSCC, the “Clearing Agencies”); and (ii) the Clearing Agency Capital Replenishment Plan (“Capital Replenishment Plan” or “Plan”) of the Clearing Agencies. In particular, the proposed revisions to the Capital Policy and Capital Replenishment Plan would (1) correct typographical errors and make other technical revisions to correct and simplify statements in the Policy and Plan; (2) replace references in the Policy and Plan to the “Credit Risk Capital Requirement” with the “Corporate Contribution;” and (3) update references in the Policy to the Recovery & Wind-down Plans of each of the Clearing Agencies, which were recently adopted by the Clearing Agencies, as described in greater detail below.
In its filing with the Commission, the clearing agency included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The clearing agency has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Clearing Agencies are proposing to revise the Capital Policy and Capital Replenishment Plan, which were adopted by the Clearing Agencies in July 2017
The Capital Policy sets forth the manner in which each Clearing Agency identifies, monitors, and manages its general business risk with respect to the requirement to hold sufficient liquid net assets (“LNA”) funded by equity to cover potential general business losses so the Clearing Agency can continue operations and services as a going concern if such losses materialize.
Currently, the Capital Policy also addresses how each Clearing Agency maintains a portion of retained earnings as LNA funded by equity as its Credit Risk Capital Requirement, as a part of its management of credit risk
The Policy also provides a plan for the replenishment of capital through the Capital Replenishment Plan. The Capital Replenishment Plan was adopted by the Clearing Agencies as a plan for the replenishment of capital by each Clearing Agency should its equity fall close to or below the amount being held as its Total Capital Requirement pursuant to the Capital Policy. The Capital Replenishment Plan identifies the circumstances that would trigger implementation of the Plan; the roles, responsibilities, and guiding principles for implementation of the Plan; and an overview and description of each of the tools that may be used to replenish capital..
As described in greater detail below, the Clearing Agencies are proposing to make certain revisions to the Capital Policy and Capital Replenishment Plan.
First, the proposed revisions would correct typographical errors and make other technical revisions to correct and simplify statements in the Capital Policy and Capital Replenishment Plan. Second, the proposed revisions would replace references to the “Credit Risk Capital Requirement” with “Corporate Contribution.” This proposed change would reflect the implementation of recent revisions to the Clearing Agencies' Rules regarding allocation of losses.
These proposed revisions are designed to enhance the clarity of the Policy and Plan and help ensure that they continue to operate as intended.
NSCC is proposing technical revisions to the descriptions within the Capital Policy and Capital Replenishment Plan that would correct typographical errors, including, for example, removing a phrase that was incorrectly repeated in the same sentence. These revisions would also correct an error in Section 3 of the Policy, where the document was incorrectly referred to as the Plan.
Such revisions would also update the documents. For example, the proposed changes would replace references in the Capital Policy and Capital Replenishment Plan to the Finance/Capital Committee of the Boards, which was disbanded September 2017, with the Boards, which has taken on the responsibilities of this Committee set forth in the Policy and Plan. These revisions would also include updating the Capital Replenishment Plan to revise the name of the “Capital Contributions to DTCC Subsidiaries and Joint Ventures Policy” to the new name of this document, the “Capital Contributions Policy.”
Finally, the proposed revisions would also simplify the descriptions in these documents. For example, these revisions would add a defined term for the Clearing Agencies' Rules to the Policy in order to simplify references to such rules and procedures in this document.
The proposed revisions would also replace references in the Capital Policy and Capital Replenishment Plan to the “Credit Risk Capital Requirement” with the “Corporate Contribution.” Currently, the Capital Policy describes how each Clearing Agency maintains a portion of retained earnings as LNA funded by equity as its Credit Risk Capital Requirement, in accordance with their respective Rules. Recently, the Clearing Agencies implemented revisions to their respective Rules to enhance the process by which they may allocate losses to their participants if the size of the losses exceed their prefunded resources.
Specifically, the NSCC Rules previously provided that NSCC would contribute no less than 25 percent of its retained earnings (or such higher amount as the NSCC Board of Directors shall determine) to a loss or liability as the result of the failure of a defaulting member that is not satisfied by the defaulting member's Clearing Fund deposit. Pursuant to these recent changes, the NSCC Rules provide that an amount equal to 50 percent of NSCC's General Business Risk Capital Requirement (as such amount is defined in the Capital Policy), or such greater amount as the NSCC Board of Directors may determine, (“Corporate Contribution”) may be used to address unsatisfied losses or liabilities arising either from a member default or a non-default event. The Corporate Contribution applied to any losses arising from events that may occur during the next 250 business days would be reduced to the remaining unused portion of Corporate Contribution, if any.
The amendments to the calculation and application of the resources that are now referred to as the Corporate Contribution did not change how these resources are described within the Policy or the Plan. The Corporate Contribution continues to represent resources maintained by the Clearing
Therefore, the Capital Policy and Capital Replenishment Plan would be revised to replace references to the Credit Risk Capital Requirement with references to the Corporate Contribution, and no other changes are needed to the description of this amount.
The proposed revisions would also update the Capital Policy to make clear that the Recovery & Wind-down Plans of the Clearing Agencies have been adopted by the Clearing Agencies.
The Recovery/Wind-down Capital Requirement is an amount based on the time estimated to execute a recovery or orderly wind-down of the critical operations of that Clearing Agency and is used by the Clearing Agencies to determine their General Business Risk Capital Requirement. Each of the Clearing Agencies recently adopted a Recovery & Wind-down Plan, which provide plans for the recovery and orderly wind-down of each of the Clearing Agencies necessitated by credit losses, liquidity shortfalls, losses from general business risk, or any other losses.
The Clearing Agencies are proposing to revise the Capital Policy to make clear that the Recovery & Wind-down Plans have now been adopted by the Clearing Agencies.
The Clearing Agencies believe that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a registered clearing agency. In particular, the Clearing Agencies believe that the Capital Policy and the Capital Replenishment Plan are both consistent with Section 17A(b)(3)(F) of the Act
Section 17A(b)(3)(F) of the Act requires, in part, that the rules of the Clearing Agencies be designed to promote the prompt and accurate clearance and settlement of securities transactions, and to assure the safeguarding of securities and funds which are in the custody or control of the Clearing Agency or for which it is responsible.
Rule 17Ad-22(e)(15) requires the Clearing Agencies to establish, implement, maintain and enforce written policies and procedures reasonably designed to identify, monitor, and manage their respective general business risk and hold sufficient liquid net assets funded by equity to cover potential general business losses so that the Clearing Agencies can continue operations and services as a going concern if those losses materialize.
Each of the Clearing Agencies believes that none of the proposed revisions to the Capital Policy and the Capital Replenishment Plan would have any impact, or impose any burden, on competition. The Policy and the Plan are maintained by the Clearing Agencies in order to satisfy their regulatory requirements and generally reflect internal tools and procedures. Tools and procedures that have a direct impact on the rights, responsibilities or obligations of members or participants of the Clearing Agencies are reflected in the Clearing Agencies' Rules. Accordingly, the Capital Policy and Capital Replenishment Plan themselves are documents that enhance the Clearing Agencies' regulatory compliance and internal management and do not have any impact, or impose any burden, on competition.
The proposed revisions to correct and update the Capital Policy and Capital Replenishment Plan would not affect any changes on the fundamental purpose or operation of these documents and, as such, would also not have any impact, or impose any burden, on competition.
The Clearing Agencies have not solicited or received any written comments relating to this proposal. The Clearing Agencies will notify the Commission of any written comments received by the Clearing Agencies.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed rule change consists of amendments to (i) the Clearing Agency Policy on Capital Requirements (“Capital Policy” or “Policy”) of FICC and its affiliates, The Depository Trust Company (“DTC”) and National Securities Clearing Corporation (“NSCC,” and together with DTC and FICC, the “Clearing Agencies”); and (ii) the Clearing Agency Capital Replenishment Plan (“Capital Replenishment Plan” or “Plan”) of the Clearing Agencies. In particular, the proposed revisions to the Capital Policy and Capital Replenishment Plan would (1) correct typographical errors and make other technical revisions to correct and simplify statements in the Policy and Plan; (2) replace references in the Policy and Plan to the “Credit Risk Capital Requirement” with the “Corporate Contribution;” and (3) update references in the Policy to the Recovery & Wind-down Plans of each of the Clearing Agencies, which were recently adopted by the Clearing Agencies, as described in greater detail below.
In its filing with the Commission, the clearing agency included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The clearing agency has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Clearing Agencies are proposing to revise the Capital Policy and Capital Replenishment Plan, which were adopted by the Clearing Agencies in July 2017
The Capital Policy sets forth the manner in which each Clearing Agency identifies, monitors, and manages its general business risk with respect to the requirement to hold sufficient liquid net assets (“LNA”) funded by equity to cover potential general business losses so the Clearing Agency can continue operations and services as a going concern if such losses materialize.
Currently, the Capital Policy also addresses how each Clearing Agency maintains a portion of retained earnings as LNA funded by equity as its Credit Risk Capital Requirement, as a part of its management of credit risk
The Policy also provides a plan for the replenishment of capital through the Capital Replenishment Plan. The Capital Replenishment Plan was adopted by the Clearing Agencies as a plan for the replenishment of capital by each Clearing Agency should its equity fall close to or below the amount being held as its Total Capital Requirement pursuant to the Capital Policy. The Capital Replenishment Plan identifies the circumstances that would trigger implementation of the Plan; the roles, responsibilities, and guiding principles for implementation of the Plan; and an overview and description of each of the tools that may be used to replenish capital.
As described in greater detail below, the Clearing Agencies are proposing to make certain revisions to the Capital Policy and Capital Replenishment Plan.
First, the proposed revisions would correct typographical errors and make other technical revisions to correct and simplify statements in the Capital Policy and Capital Replenishment Plan. Second, the proposed revisions would replace references to the “Credit Risk Capital Requirement” with “Corporate Contribution.” This proposed change would reflect the implementation of recent revisions to the Clearing Agencies' Rules regarding allocation of losses.
These proposed revisions are designed to enhance the clarity of the Policy and Plan and help ensure that they continue to operate as intended.
FICC is proposing technical revisions to the descriptions within the Capital Policy and Capital Replenishment Plan that would correct typographical errors, including, for example, removing a phrase that was incorrectly repeated in the same sentence. These revisions would also correct an error in Section 3 of the Policy, where the document was incorrectly referred to as the Plan.
Such revisions would also update the documents. For example, the proposed changes would replace references in the Capital Policy and Capital Replenishment Plan to the Finance/Capital Committee of the Boards, which was disbanded September 2017, with the Boards, which has taken on the responsibilities of this Committee set forth in the Policy and Plan. These revisions would also include updating the Capital Replenishment Plan to revise the name of the “Capital Contributions to DTCC Subsidiaries and Joint Ventures Policy” to the new name of this document, the “Capital Contributions Policy.”
Finally, the proposed revisions would also simplify the descriptions in these documents. For example, these revisions would add a defined term for the Clearing Agencies' Rules to the Policy in order to simplify references to such rules and procedures in this document.
The proposed revisions would also replace references in the Capital Policy and Capital Replenishment Plan to the “Credit Risk Capital Requirement” with the “Corporate Contribution.” Currently, the Capital Policy describes how each Clearing Agency maintains a portion of retained earnings as LNA funded by equity as its Credit Risk Capital Requirement, in accordance with their respective Rules. Recently, the Clearing Agencies implemented revisions to their respective Rules to enhance the process by which they may allocate losses to their participants if the size of the losses exceed their prefunded resources.
Specifically, the GSD Rules and MBSD Rules previously provided that FICC would contribute up to 25 percent of its retained earnings (or such higher amount as the FICC Board of Directors shall determine) to a loss or liability as the result of the failure of a defaulting member that is not satisfied by the defaulting member's Clearing Fund deposit. Pursuant to these recent changes, the GSD Rules and MBSD Rules provide that an amount equal to 50 percent of FICC's General Business Risk Capital Requirement (as such amount is defined in the Capital Policy), or such greater amount as the FICC Board of Directors may determine, (“Corporate Contribution”) may be used to address unsatisfied losses or liabilities arising either from a member default or a non-default event. The Corporate Contribution applied to any losses arising from events that may occur during the next 250 business days would be reduced to the remaining
The amendments to the calculation and application of the resources that are now referred to as the Corporate Contribution did not change how these resources are described within the Policy or the Plan. The Corporate Contribution continues to represent resources maintained by the Clearing Agencies to address losses due to a participant default, as a part of their management of credit risk.
Therefore, the Capital Policy and Capital Replenishment Plan would be revised to replace references to the Credit Risk Capital Requirement with references to the Corporate Contribution, and no other changes are needed to the description of this amount.
The proposed revisions would also update the Capital Policy to make clear that the Recovery & Wind-down Plans of the Clearing Agencies have been adopted by the Clearing Agencies.
The Recovery/Wind-down Capital Requirement is an amount based on the time estimated to execute a recovery or orderly wind-down of the critical operations of that Clearing Agency and is used by the Clearing Agencies to determine their General Business Risk Capital Requirement. Each of the Clearing Agencies recently adopted a Recovery & Wind-down Plan, which provide plans for the recovery and orderly wind-down of each of the Clearing Agencies necessitated by credit losses, liquidity shortfalls, losses from general business risk, or any other losses.
The Clearing Agencies are proposing to revise the Capital Policy to make clear that the Recovery & Wind-down Plans have now been adopted by the Clearing Agencies.
The Clearing Agencies believe that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a registered clearing agency. In particular, the Clearing Agencies believe that the Capital Policy and the Capital Replenishment Plan are both consistent with Section 17A(b)(3)(F) of the Act
Section 17A(b)(3)(F) of the Act requires, in part, that the rules of the Clearing Agencies be designed to promote the prompt and accurate clearance and settlement of securities transactions, and to assure the safeguarding of securities and funds which are in the custody or control of the Clearing Agency or for which it is responsible.
Rule 17Ad-22(e)(15) requires the Clearing Agencies to establish, implement, maintain and enforce written policies and procedures reasonably designed to identify, monitor, and manage their respective general business risk and hold sufficient liquid net assets funded by equity to cover potential general business losses so that the Clearing Agencies can continue operations and services as a going concern if those losses materialize.
Each of the Clearing Agencies believes that none of the proposed revisions to the Capital Policy and the Capital Replenishment Plan would have any impact, or impose any burden, on competition. The Policy and the Plan are maintained by the Clearing Agencies in order to satisfy their regulatory requirements and generally reflect internal tools and procedures. Tools and procedures that have a direct impact on the rights, responsibilities or obligations of members or participants of the Clearing Agencies are reflected in the Clearing Agencies' Rules. Accordingly, the Capital Policy and Capital Replenishment Plan themselves are documents that enhance the Clearing Agencies' regulatory compliance and internal management and do not have any impact, or impose any burden, on competition.
The proposed revisions to correct and update the Capital Policy and Capital Replenishment Plan would not affect any changes on the fundamental purpose or operation of these documents and, as such, would also not have any impact, or impose any burden, on competition.
The Clearing Agencies have not solicited or received any written comments relating to this proposal. The Clearing Agencies will notify the Commission of any written comments received by the Clearing Agencies.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to delete the current rules on arbitration (“Current Arbitration Rules”), under Chapter 18, and incorporate by reference The Nasdaq Stock Market LLC's (“Nasdaq”) rules on arbitration at General 6 (“Proposed Arbitration Rules”), into General 6 of the Exchange's rulebook's (“Rulebook”) shell structure.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to delete the rules on arbitration, currently under Chapter 18, and incorporate by reference the Nasdaq rules on arbitration at General 6 of Nasdaq's rulebook into General 6 of the Exchange's Rulebook.
The Exchange adopted the Current Arbitration Rules to ensure a fair and efficient manner in which to handle any dispute, claim or controversy arising out of, or in connection with, the business of any Member of the Exchange. To help administer the process of dispute resolution, the Exchange and FINRA are parties to a Regulatory Contract, pursuant to which FINRA has agreed to perform certain functions and provide access to certain services, including: Member regulation and registration; non-real time market surveillance; examinations and investigations; and dispute resolution. FINRA currently operates the largest securities dispute resolution forum in the United States,
Because the Affiliated Exchanges are also parties to similar Regulatory Contracts with FINRA that make their members and associated persons of such members subject to the FINRA Code of Arbitration Procedure, the Exchange believes it is pertinent that a common set of rules on arbitration be included in the General section of the Rulebook's shell. Nasdaq completed this process recently
Therefore, the Exchange will incorporate by reference the Proposed Arbitration Rules in “General 6 Arbitration” of the shell's “General Rules” section.
The relocation and harmonization of the arbitration rules is part of the Exchange's continued effort to promote efficiency and conformity of its processes with those of its Affiliated Exchanges.
GEMX will continue to file proposed rule changes to amend its General 6 Rules until such time as it receives an exemption from the Securities and Exchange Commission, pursuant to its authority under Section 36 of the Exchange Act of 1934 (“Act”) and Rule 0-12
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The proposed changes do not impose a burden on competition because, as previously stated, they are (i) of a non-substantive nature, (ii) intended to harmonize the structure of the Exchange's rules with those of its Affiliated Exchanges, and (iii) intended to organize the Rulebook in a way that it will ease the Members' navigation and reading of the rules across the Affiliated Exchanges.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly.
All submissions should refer to File Number SR-GEMX-2018-35 and should be submitted on or before November 9, 2018.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The principal purpose of the proposed rule change is to revise the ICC Stress Testing Framework and the ICC Liquidity Risk Management Framework. These revisions do not require any changes to the ICC Clearing Rules (“Rules”).
In its filing with the Commission, ICC included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. ICC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of these statements.
ICC proposes revising its Stress Testing Framework and its Liquidity Risk Management Framework. Specifically, ICC proposes clarifying changes regarding current aspects of its stress testing and liquidity stress testing practices to address comments received from independent validations, as well as additional clean-up changes. The independent validator comments revolve around clarification updates that do not change ICC's current stress testing and liquidity stress testing practices. ICC's proposed changes to address the independent validator comments include updates to correct inconsistencies between section numbering and the table of contents, ensure that scenarios are categorized consistently across the ICC Stress Testing Framework and the ICC Liquidity Risk Management Framework, define potentially unclear terminology, and clarify or include additional detail relating to potentially ambiguous phrases or text such that ICC's documentation provides a clearer view of its stress testing and liquidity stress testing practices. ICC believes such revisions will facilitate the prompt and accurate clearance and settlement of securities transactions and derivative agreements, contracts, and transactions for which it is responsible. The proposed revisions are described in detail as follows.
ICC proposes revisions to the Stress Testing Framework to address independent validator comments and to make clarification and clean-up changes to enhance readability. ICC proposes clean-up changes to the Table of Contents to add two sections, which are not new to the document, but were previously excluded from the Table of Contents. ICC also proposes, for clarity, updates to the `Overview' section to abbreviate “Risk Committee” to “RC.” ICC proposes corresponding changes throughout the document.
ICC proposes amendments to the `Predefined Scenarios' section of the Stress Testing Framework. ICC proposes to divide the predefined scenarios into four categories. Previously, the Stress Testing Framework divided the predefined scenarios into three categories by combining the Historically Observed Extreme but Plausible Market Scenarios: Severity of Losses in Response to a Baseline Credit Event and the Hypothetically Constructed (Forward Looking) Extreme but Plausible Market Scenarios into one category. ICC proposes to separate these scenarios into two categories to maintain uniformity throughout the Stress Testing Framework since each represents a distinct sub-section in the `Predefined Scenarios' section of the Stress Testing Framework. Additionally, ICC proposes to categorize the Discordant Spread Scenarios (
ICC proposes clarifying changes to the `Display of Discordant Behavior among Instrument Groups' section. ICC proposes to more clearly define discordant change as discordant relative spread move. ICC proposes to add clarifying language to define the market depth of sovereign reference entities in terms of the observed weekly trading volumes from the Depository Trust & Clearing Corporation (“DTCC”). In addition, ICC proposes to include language to clarify that the historical period selected to represent the greatest combined discordant change for sovereign reference entities can be different from the one selected for corporate single names (“SNs”).
ICC proposes enhancements to the `Reverse Stress Testing: Guaranty Fund Adequacy Analysis' section to provide additional clarity regarding how ICC performs such analysis. Specifically, ICC proposes to add explanatory language to note that, upon the simultaneous default of two Clearing Participant (“CP”) affiliate groups (“AGs”), ICC considers additional adverse spread realizations and idiosyncratic credit events associated with reference obligations on which the stress tested CP sold protection.
ICC proposes enhancements to the `Interest Rate Sensitivity Analysis'
ICC proposes clarification changes to the `Guaranty Fund Sizing Sensitivity Analysis' section. ICC's Guaranty Fund (“GF”) model aims to establish financial resources that are sufficient to cover hypothetical losses associated with the simultaneous credit events where up to five SN Risk Factor Groups (“RFGs”)
ICC proposes updates to the `Interpretation of Results' section. For clarity, ICC proposes revisions to specify when it assesses Cover-2 in terms of two CP AGs generating the largest uncollateralized stress losses (
ICC proposes amending the `Post-Stress Testing Review & Governance Structure' section to more clearly reflect the ICC Risk Department's reporting and stress testing obligations. The proposed changes clarify that, for each considered stress scenario, the ICC Risk Department creates and reviews stress testing results for all applicable CP AGs. The proposed changes further specify which scenarios are provided weekly for reporting purposes and which are provided monthly to the Risk Committee. The proposed changes also note the ICC Risk Department's reporting obligation if deficiencies are uncovered during analysis of certain Cover-2 stress scenarios, along with the ICC Risk Department's obligation to execute stress testing regularly for all CP AGs.
ICC proposes revisions to its Liquidity Risk Management Framework to make clean-up changes and clarification changes in response to independent validator comments. Specifically, ICC proposes to revise the `Discordant Scenario' sub-section to more clearly define discordant change as discordant relative spread move. In addition, consistent with the Stress Testing Framework, ICC proposes modifying the `Required Analysis' section to more clearly reflect the ICC Risk Department's reporting and stress testing obligations. ICC proposes to note that, for each considered stress scenario, the ICC Risk Department executes stress testing daily for all applicable CP AGs. ICC also proposes to specify which scenarios are provided weekly for reporting purposes and which are provided monthly to the Risk Committee.
Section 17A(b)(3)(F) of the Act
In addition, the proposed revisions to the Stress Testing Framework and the Liquidity Risk Management Framework are consistent with the relevant requirements of Rule 17Ad-22.
Rule 17Ad-22(d)(8)
ICC does not believe the proposed rule changes would have any impact, or impose any burden, on competition. The proposed changes to ICC's Stress Testing Framework and ICC's Liquidity Risk Management Framework will apply uniformly across all market participants. Therefore, ICC does not believe the proposed rule changes impose any burden on competition that is inappropriate in furtherance of the purposes of the Act.
Written comments relating to the proposed rule change have not been solicited or received. ICC will notify the Commission of any written comments received by ICC.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act and paragraph (f) of Rule 19b-4 thereunder. At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ICC-2018-010 and should be submitted on or before November 9, 2018.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed rule change consists of amendments to (i) the Clearing Agency Policy on Capital Requirements (“Capital Policy” or “Policy”) of DTC and its affiliates, National Securities Clearing Corporation (“NSCC”) and Fixed Income Clearing Corporation (“FICC,” and together with DTC and NSCC, the “Clearing Agencies”); and (ii) the Clearing Agency Capital Replenishment Plan (“Capital Replenishment Plan” or “Plan”) of the
In its filing with the Commission, the clearing agency included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The clearing agency has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Clearing Agencies are proposing to revise the Capital Policy and Capital Replenishment Plan, which were adopted by the Clearing Agencies in July 2017
The Capital Policy sets forth the manner in which each Clearing Agency identifies, monitors, and manages its general business risk with respect to the requirement to hold sufficient liquid net assets (“LNA”) funded by equity to cover potential general business losses so the Clearing Agency can continue operations and services as a going concern if such losses materialize.
Currently, the Capital Policy also addresses how each Clearing Agency maintains a portion of retained earnings as LNA funded by equity as its Credit Risk Capital Requirement, as a part of its management of credit risk
The Policy also provides a plan for the replenishment of capital through the Capital Replenishment Plan. The Capital Replenishment Plan was adopted by the Clearing Agencies as a plan for the replenishment of capital by each Clearing Agency should its equity fall close to or below the amount being held as its Total Capital Requirement pursuant to the Capital Policy. The Capital Replenishment Plan identifies the circumstances that would trigger implementation of the Plan; the roles, responsibilities, and guiding principles for implementation of the Plan; and an overview and description of each of the tools that may be used to replenish capital.
As described in greater detail below, the Clearing Agencies are proposing to make certain revisions to the Capital Policy and Capital Replenishment Plan.
First, the proposed revisions would correct typographical errors and make other technical revisions to correct and simplify statements in the Capital Policy and Capital Replenishment Plan. Second, the proposed revisions would replace references to the “Credit Risk Capital Requirement” with “Corporate Contribution.” This proposed change would reflect the implementation of recent revisions to the Clearing Agencies' Rules regarding allocation of losses.
These proposed revisions are designed to enhance the clarity of the Policy and Plan and help ensure that they continue to operate as intended.
DTC is proposing technical revisions to the descriptions within the Capital Policy and Capital Replenishment Plan that would correct typographical errors, including, for example, removing a phrase that was incorrectly repeated in the same sentence. These revisions would also correct an error in Section 3 of the Policy, where the document was incorrectly referred to as the Plan.
Such revisions would also update the documents. For example, the proposed changes would replace references in the Capital Policy and Capital Replenishment Plan to the Finance/Capital Committee of the Boards, which was disbanded September 2017, with
Finally, the proposed revisions would also simplify the descriptions in these documents. For example, these revisions would add a defined term for the Clearing Agencies' Rules to the Policy in order to simplify references to such rules and procedures in this document.
The proposed revisions would also replace references in the Capital Policy and Capital Replenishment Plan to the “Credit Risk Capital Requirement” with the “Corporate Contribution.” Currently, the Capital Policy describes how each Clearing Agency maintains a portion of retained earnings as LNA funded by equity as its Credit Risk Capital Requirement, in accordance with their respective Rules. Recently, the Clearing Agencies implemented revisions to their respective Rules to enhance the process by which they may allocate losses to their participants if the size of the losses exceed their prefunded resources.
Specifically, the DTC Rules previously provided that DTC could, in its discretion and in such amounts as it would determine, charge its existing retained earnings and undivided profits to a loss or liability, to the extent that it is not satisfied by the Actual Participants Fund Deposit and Preferred Stock of the defaulting Participant. Pursuant to these recent changes, the DTC Rules require that DTC contribute an amount equal to 50 percent of DTC's General Business Risk Capital Requirement (as such amount is defined in the Capital Policy) (“Corporate Contribution”) towards losses or liabilities arising from a Participant default or non-default event. DTC may also voluntarily apply amounts greater than the Corporate Contribution, as the DTC Board of Directors may determine. The Corporate Contribution applied to any losses arising from events that may occur during the next 250 business days would be reduced to the remaining unused portion of Corporate Contribution, if any.
The amendments to the calculation and application of the resources that are now referred to as the Corporate Contribution did not change how these resources are described within the Policy or the Plan. The Corporate Contribution continues to represent resources maintained by the Clearing Agencies to address losses due to a participant default, as a part of their management of credit risk.
Therefore, the Capital Policy and Capital Replenishment Plan would be revised to replace references to the Credit Risk Capital Requirement with references to the Corporate Contribution, and no other changes are needed to the description of this amount.
The proposed revisions would also update the Capital Policy to make clear that the Recovery & Wind-down Plans of the Clearing Agencies have been adopted by the Clearing Agencies.
The Recovery/Wind-down Capital Requirement is an amount based on the time estimated to execute a recovery or orderly wind-down of the critical operations of that Clearing Agency and is used by the Clearing Agencies to determine their General Business Risk Capital Requirement. Each of the Clearing Agencies recently adopted a Recovery & Wind-down Plan, which provide plans for the recovery and orderly wind-down of each of the Clearing Agencies necessitated by credit losses, liquidity shortfalls, losses from general business risk, or any other losses.
The Clearing Agencies are proposing to revise the Capital Policy to make clear that the Recovery & Wind-down Plans have now been adopted by the Clearing Agencies.
The Clearing Agencies believe that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a registered clearing agency. In particular, the Clearing Agencies believe that the Capital Policy and the Capital Replenishment Plan are both consistent with Section 17A(b)(3)(F) of the Act
Section 17A(b)(3)(F) of the Act requires, in part, that the rules of the Clearing Agencies be designed to promote the prompt and accurate clearance and settlement of securities transactions, and to assure the safeguarding of securities and funds which are in the custody or control of the Clearing Agency or for which it is responsible.
Rule 17Ad-22(e)(15) requires the Clearing Agencies to establish, implement, maintain and enforce written policies and procedures reasonably designed to identify, monitor, and manage their respective general business risk and hold sufficient
Each of the Clearing Agencies believes that none of the proposed revisions to the Capital Policy and the Capital Replenishment Plan would have any impact, or impose any burden, on competition. The Policy and the Plan are maintained by the Clearing Agencies in order to satisfy their regulatory requirements and generally reflect internal tools and procedures. Tools and procedures that have a direct impact on the rights, responsibilities or obligations of members or participants of the Clearing Agencies are reflected in the Clearing Agencies' Rules. Accordingly, the Capital Policy and Capital Replenishment Plan themselves are documents that enhance the Clearing Agencies' regulatory compliance and internal management and do not have any impact, or impose any burden, on competition.
The proposed revisions to correct and update the Capital Policy and Capital Replenishment Plan would not affect any changes on the fundamental purpose or operation of these documents and, as such, would also not have any impact, or impose any burden, on competition.
The Clearing Agencies have not solicited or received any written comments relating to this proposal. The Clearing Agencies will notify the Commission of any written comments received by the Clearing Agencies.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of North Carolina (FEMA-4393-DR), dated 10/12/2018.
Issued on 10/12/2018.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on
The following areas have been determined to be adversely affected by the disaster:
The number assigned to this disaster for physical damage is 157468 and for economic injury is 157470.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for the State of Georgia (FEMA-4400-DR), dated 10/14/2018.
Issued on 10/14/2018.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 10/14/2018, applications for disaster loans may be filed at the address listed above or other locally announced locations. The following areas have been determined to be adversely affected by the disaster:
The number assigned to this disaster for physical damage is 157448 and for economic injury is 157450.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for the State of Florida (FEMA-4399-DR), dated 10/11/2018.
Issued on 10/11/2018.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 10/11/2018, applications for disaster loans may be filed at the address listed above or other locally announced locations. The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 157428 and for economic injury is 157430.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for the State of Florida (FEMA-4399-DR), dated 10/11/2018.
Issued on 10/12/2018.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
The notice of the President's major disaster declaration for the State of Florida, dated 10/11/2018, is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 2.
This is an amendment of the Presidential declaration of a major disaster for the State of Florida (FEMA-4399-DR), dated 10/11/2018.
Issued on 10/13/2018.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
The notice of the President's major disaster declaration for the State of FLORIDA, dated 10/11/2018, is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
In accordance with section 4314(c)(4) of 5 United States Code, the Department of State has appointed the following individuals to the Department of State Performance Review Board for Senior Executive Service members:
Jeffrey C. Mounts, Chairperson, Deputy Comptroller, Comptroller, Global Financial Services, Department of State;
Maegan Conklin, Assistant Legal Adviser, Office of the Legal Adviser, Department of State;
Eliot Kang, Principal Deputy Assistant Secretary, Bureau of International Security and Nonproliferation, Department of State;
Cathy J. Read, Procurement Executive, Bureau of Administration, Department of State; and,
Marc L. Ostfield, Deputy Director, Foreign Service Institute, Department of State.
Notice is hereby given of the following determinations: I hereby determine that the objects to be exhibited in the exhibition “Renaissance Splendor: Catherine de Medici's Valois Tapestries,” imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display
Julie Simpson, Attorney-Adviser, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Notice is hereby given of the following determinations: I hereby determine that the objects to be exhibited in the exhibition “Mrinalini Mukherjee,” imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at The Metropolitan Museum of Art at The Met Breuer, New York, New York, from on or about June 4, 2019, until on or about September 29, 2019, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these determinations be published in the
Julie Simpson, Attorney-Adviser, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Susquehanna River Basin Commission.
Notice.
This notice lists the projects approved by rule by the Susquehanna River Basin Commission during the period set forth in
September 1-30, 2018.
Susquehanna River Basin Commission, 4423 North Front Street, Harrisburg, PA 17110-1788.
Jason E. Oyler, General Counsel, telephone: (717) 238-0423, ext. 1312; fax: (717) 238-2436; email:
This notice lists the projects, described below, receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(e) and 806.22 (f) for the time period specified above:
1. Repsol Oil & Gas USA, LLC, Pad ID: MURPHY (07 075) D, ABR-201309002.R1; Apolacon Township, Susquehanna County, Pa.; Consumptive Use of Up to 6.0000 mgd; Approval Date: September 10, 2018.
2. Repsol Oil & Gas USA, LLC, Pad ID: BUTLER (07 086) J, ABR-201309003.R1; Apolacon Township, Susquehanna County, Pa.; Consumptive Use of Up to 6.0000 mgd; Approval Date: September 10, 2018.
3. Repsol Oil & Gas USA, LLC, Pad ID: OLYMPIC LAKE ESTATES (07 083), ABR-201309005.R1; Apolacon Township, Susquehanna County, Pa.; Consumptive Use of Up to 6.0000 mgd; Approval Date: September 10, 2018.
4. SWN Production Company, LLC, Pad ID: Salt Lick Hunting Club-Range-Pad59, ABR-201310002.R1; New Milford Township, Susquehanna County, Pa.; Consumptive Use of Up to 4.9990 mgd; Approval Date: September 10, 2018.
5. SWEPI LP, Pad ID: Bradford 481, ABR-201309008.R1; Sullivan Township, Tioga County, Pa.; Consumptive Use of Up to 4.0000 mgd; Approval Date: September 21, 2018.
6. Cabot Oil & Gas Corporation, Pad ID: StoddardT P1, ABR-201309012.R1; Lenox Township, Susquehanna County, Pa.; Consumptive Use of Up to 5.0000 mgd; Approval Date: September 24, 2018.
Pub. L. 91-575, 84 Stat. 1509
Susquehanna River Basin Commission.
Notice.
This notice lists the approved by rule projects rescinded by the Susquehanna River Basin Commission during the period set forth in
September 1-30, 2018.
Susquehanna River Basin Commission, 4423 North Front Street, Harrisburg, PA 17110-1788.
Jason E. Oyler, General Counsel, telephone: (717) 238-0423, ext. 1312; fax: (717) 238-2436; email:
This notice lists the projects, described below, being rescinded for the consumptive use of water pursuant to the Commission's approval by rule
Public Law 91-575, 84 Stat. 1509
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before November 8, 2018.
Send comments identified by docket number FAA-2018-0612 using any of the following methods:
•
•
•
•
Christopher Bailey at (202) 267-4158, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Highway Administration (FHWA), Department of Transportation (DOT).
Notice of limitation on claims for judicial review of actions by FHWA.
This notice announces actions taken by the FHWA that are final. The action relates to the need to remove wireless communications facilities serving AT&T, Sprint, T-Mobile, and Verizon from the Montlake 76 Service Station and Montlake Boulevard Market property and replace the service provided at a temporary site for the duration of SR 520, I-5 to Medina construction in the City of Seattle, King County, State of Washington.
A claim seeking judicial review of the Federal agency actions on the listed highway project will be barred unless the claim is filed on or before March 18, 2019. If the Federal law that authorizes judicial review of a claim provides a time period of less than 150 days for filing such claim, then that shorter time period still applies.
Jeff Horton, Area Engineer, Federal Highway Administration, 711 S Capitol Way, Suite 501, Olympia, WA 98501-1284, 360-753-9411, or
On September 7, 2011, FHWA published a “Notice of Final Federal Agency Actions on Proposed Highway in Washington” in the
The project proposed to improve safety and mobility for people and goods across Lake Washington by replacing the SR 520 Portage Bay and Evergreen Point bridges and improve existing roadway between Interstate 5 (I-5) in Seattle and Evergreen Point Road in Medina spanning 5.2 miles. The Final Environmental Impact Statement (EIS) for the project was published in January 2011 and the Record of Decision (ROD) was issued in August 2011.
Since issuance of the FHWA ROD, the design and construction approach has been refined such that wireless communications facilities collocated with the Montlake 76 Service Station and Montlake Boulevard Market property would need to be removed to complete construction of the Montlake Phase. A new temporary wireless communications facility will be constructed along Lake Washington Boulevard East near East Miller Street and 26th Avenue East for the duration of SR 520 construction to replace the service provided by the removed facilities. The re-evaluation considering this refinement was issued on September 4, 2018. It identifies and documents potential effects associated with the refinement. This notice only applies to the re-evaluation.
Information about the re-evaluation and associated records are available from FHWA and WSDOT at the addresses provided above and can be found at:
1.
2.
3.
4.
5.
6.
7.
8.
23 U.S.C. 139(l)(1), as amended by Moving Ahead for Progress in the 21st Century Act, (PL 112-141, 126 Stat. 405).
Federal Highway Administration (FHWA), Department of Transportation (DOT).
Notice of limitation on claims for judicial review of actions by FHWA.
This notice announces actions taken by the FHWA that are final. The action relates to the need to close and demolish the Montlake Boulevard Market for construction along State Route (SR) 520 in the City of Seattle, King County, State of Washington.
A claim seeking judicial review of the Federal agency actions on the listed highway project will be barred unless the claim is filed on or before March 18, 2019. If the Federal law that authorizes judicial review of a claim provides a time period of less than 150 days for filing such claim, then that shorter time period still applies.
Jeff Horton, Area Engineer, Federal Highway Administration, 711 S Capitol Way, Suite 501, Olympia, WA 98501-1284, 360-753-9411, or
On September 7, 2011, FHWA published a “Notice of Final Federal Agency Actions on Proposed Highway in Washington” in the
The project proposed to improve safety and mobility for people and goods across Lake Washington by replacing the SR 520 Portage Bay and Evergreen Point bridges and improve existing roadway between Interstate 5 (I-5) in Seattle and Evergreen Point Road in Medina spanning 5.2 miles. The Final Environmental Impact Statement (EIS) for the project was published in January 2011 and the Record of Decision (ROD) was issued in August 2011.
Since issuance of the FHWA ROD, the design and construction approach has been refined such that the Montlake Boulevard Market will need to be closed and demolished as part of construction activities. The re-evaluation considering this refinement was issued on July 18, 2018. It identifies and documents potential effects associated with the refinement. This notice only applies to the re-evaluation.
Information about the re-evaluation and associated records are available from FHWA and WSDOT at the
1.
2.
3.
4.
5.
6.
7.
8.
23 U.S.C. 139(1)(1), as amended by Moving Ahead for Progress in the 21st Century Act, (PL 112-141, 126 Stat. 405).
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition.
The Federal Motor Carrier Safety Administration (FMCSA) announces its decision to grant Castignoli Enterprises' (Castignoli) application for a limited 5-year exemption to allow a sleeper berth to be installed in the bed of a Ford F350 pickup truck that, when operated in combination with certain trailers, is a commercial motor vehicle (CMV) under the Federal Motor Carrier Safety Regulations (FMCSRs). A sleeper berth installed in the bed of the pickup truck does not meet the access, location, exit, communication, or occupant restraint requirements for sleeper berths as prescribed in the FMCSRs. The Agency has determined that allowing the sleeper berth to be installed in the bed of the pickup would not have an adverse impact on safety and that adherence to the terms and conditions of the exemption will likely achieve a level of safety equivalent to or greater than the level of safety provided by the regulation.
This exemption is applicable October 19, 2018 and ending Thursday, October 19th, 2023.
Mr. Luke Loy, Vehicle and Roadside Operations Division, Office of Carrier, Driver, and Vehicle Safety, MC-PSV, (202) 366-0676, Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from certain parts of the Federal Motor Carrier Safety Regulations. FMCSA must publish a notice of each exemption request in the
The Agency reviews safety analyses and public comments submitted, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the
Castignoli applied for an exemption from 49 CFR 393.76(a)(3), (b)(2), (c), (d), and (h) to allow a sleeper berth to be installed in the bed of a Ford F350 pickup truck. A copy of the application is included in the docket referenced at the beginning of this notice.
Section 393.76 of the FMCSRs provides various requirements for sleeper berths installed in in CMVs. Specific to Castignoli's exemption application:
1. Section 393.76(a)(3), “
2. Section 393.76(b)(2), “
3. Section 393.76(c), “
4. Section 393.76(d), “
5. Section 393.76(h), “
The applicant states that he is the owner/operator of Castignoli, and is the “solo driver of a hot shot hauler, F350 1-ton pickup with trailer . . .”
I plan to incorporate the sleeper berth into the bed of the tow vehicle. The utilization of this type of sleeper berth, would allow myself (as the sole driver) to meet the hours of [10-hour] service rest period requirements by utilizing a sleeper berth incorporated into the bed of the vehicle (Rear covered, ventilated, insulated, bed with cap and full size twin mattress) in lieu of a motel each evening. The tow vehicle/trailer combination would not be operating on the roadway during my 10-hour rest period, so there is no benefit in having the access requirements to the driver compartment, nor any need for communication with the driver (myself), nor any occupant restraint requirement as the vehicle is not moving while I am sleeping. The sleeper berth is separate from the trailer behind the tow vehicle, and is therefore separate from the cargo.
The current FMCSR regulatory requirements for sleeper berth access seem to rely on the assumption that one driver is driving while another driver is in the sleeper berth, and that the truck is moving always. The situation that I have as a single driver is that when I am off duty, the vehicle is not moving and therefore direct access to the sleeper berth area should not be required, and since the vehicle is not moving there is no need for occupant restraint systems nor a means for communication with the driver. All other dimensional requirements, ventilation, and protection against exhaust and fuel leaks will be met.
The applicant states that because of mobility issues associated with a partially fused spine, it is easier for him to access a sleeper berth installed in the bed of the pickup truck as opposed to a sleeper berth that could be installed in the back seat of the pickup truck that meets the requirements of the FMCSRs. The exemption would apply only to Castignoli's sole driver and pickup truck. Castignoli believes that the sleeper berth installed in the bed of the pickup truck will maintain a level of safety that is equivalent to, or greater than, the level of safety achieved without the exemption.
FMCSA published a notice of the application in the
The FMCSA has evaluated the Castignoli exemption application, and the comments received. The Agency believes that granting the temporary exemption to allow a sleeper berth to be installed in the pickup truck bed will provide a level of safety that is equivalent to, or greater than, the level of safety achieved without the exemption. Sleeper berths provide an option for drivers to obtain the rest necessary under the hours-of-service rules in part 395 of the FMCSRs without having to pay lodging costs at a hotel/motel. In the case of team driving operations, a sleeper berth allows one person to obtain the necessary rest (a “relief driver”) while the other person is driving, allowing a vehicle to be operated continuously and thereby increasing productivity.
Previous rulemakings have specifically noted the use of sleeper berths by relief drivers in team driving operations. The sleeper berth requirements were revised in April 1974 to increase the minimum interior dimensional requirements for sleeper berths in CMVs (39 FR 14710). In that final rule, the Federal Highway Administration's Bureau of Motor Carrier Safety (the predecessor to FMCSA) stated that “In sleeper berth trucking operations it is of critical importance that
In team driving operations, it is important for the person in the sleeper berth (
The Agency hereby grants the exemption for a 5-year period, beginning October 19, 2018 and ending
The exemption will be valid for 5 years unless rescinded earlier by FMCSA. The exemption will be rescinded if: (1) Castignoli fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b).
Interested parties possessing information that would demonstrate that Castignoli's use of a sleeper berth installed in the bed of pickup truck when operating as a CMV is not achieving the requisite statutory level of safety should immediately notify FMCSA. The Agency will evaluate any such information and, if safety is being compromised or if the continuation of the exemption is not consistent with 49 U.S.C. 31136(e) and 31315(b), will take immediate steps to revoke the exemption.
In accordance with 49 U.S.C. 31313(d), as implemented by 49 CFR 381.600, during the period this exemption is in effect, no State shall enforce any law or regulation applicable to interstate commerce that conflicts with or is inconsistent with this exemption with respect to Castignoli Enterprises operating under the exemption. States may, but are not required to, adopt the same exemption with respect to operations in intrastate commerce.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition; grant of application for exemption.
FMCSA announces its decision to renew CRST Expedited (CRST) exemption from the regulation that requires a commercial learner's permit (CLP) holder to be accompanied by a commercial driver's license (CDL) holder with the proper CDL class and endorsements, seated in the front seat of the vehicle while the CLP holder performs behind-the-wheel training on public roads or highways. Under the terms and conditions of this exemption, a CLP holder who has documentation of passing the CDL skills test may drive a commercial motor vehicle (CMV) for CRST without being accompanied by a CDL holder in the front seat of the vehicle. The exemption enables CLP holders to drive as part of a team with the same regulatory flexibility as CRST team drivers with CDLs. FMCSA has analyzed the exemption application and the public comments and has determined that the exemption, subject to the terms and conditions imposed, will achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption.
This exemption is effective September 23, 2018 and expires September 24, 2023.
Ms. Pearlie Robinson, FMCSA Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards; Telephone: (202) 366-4225. Email:
To view comments, as well as documents mentioned in this preamble as being available in the docket, go to
FMCSA has authority under 49 U.S.C. 31136(e) and 31315(b) to grant exemptions from certain Federal Motor Carrier Safety Regulations (FMCSRs). FMCSA must publish a notice of each exemption request in the
The Agency reviews safety analyses and public comments submitted, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the
CRST's initial exemption application from the provisions of 49 CFR 383.25(a)(1) was submitted in 2015; a copy is in the docket identified at the beginning of this notice. The 2015 application described fully the nature of the CRST's operations and CMV drivers. The exemption was originally granted on September 23, 2016 (81 FR 65696) for a two-year period. CRST now requests a renewal of the exemption.
The current exemption excuses CRST from the requirement that a driver accompanying a CLP holder must be physically present at all times in the front seat of a CMV, on the condition that the CLP holder has successfully passed an approved CDL skills test. CRST's 2015 application argued that the existing requirement is inefficient and unproductive, as the company must incur added expense to send the driver
CRST states that the exemption does not negatively affect safety outcomes. Instead, the exemption allows drivers trained out-of-State to obtain on-the-job experience in CRST's comprehensive training program while avoiding significant delays and skill degradation. The exemption creates immediate economic and safety benefits for both the CLP holders and CRST—drivers earn an income as part of a team operation while improving their driver skills and gaining valuable experience.
CRST indicated in its renewal application that data show that drivers utilizing the exemption demonstrated better safety outcomes than non-exempt drivers. Through the end of 2017, CRST reported zero accidents to FMCSA involving drivers utilizing the exemption.
In the June 12, 2017,
On August 9, 2018, FMCSA published notice of this application and requested public comment (83 FR 39495). The Agency received eight comments. Seven individuals posted comments in opposition to renewal of the exemption. For example, Mr. Jarrod Hough wrote, “Why would FMCSA even consider this? The roads and traffic is bad enough already. Permit holders don't have the experience to operate a commercial vehicle by themselves without the trainer sitting upfront and in the passenger seat. That is what a trainer is for, to teach and give guidance to the student. Not to be in the sleeper berth while the student is left alone.” Mr. Joe Ammons supported the exemption if CRST was required to meet certain conditions, such as showing the exemption was not continued beyond a reasonable period of time before dispatching a permitted driver to his/her home State to complete the licensing process.
FMCSA has evaluated CRST's application for exemption and the public comments. The Agency believes that CRST's overall safety performance, as reflected in its “satisfactory” safety rating, will enable it to achieve a level of safety that is equivalent to, or greater than, the level of safety achieved without the exemption (49 CFR 381.305(a)). The exemption is restricted to CRST's CLP holders who have documentation that they have passed the CDL skills test. The exemption will enable these drivers to operate a CMV as a team driver without requiring the accompanying CDL holder be on duty and in the front seat while the vehicle is moving. Because these drivers have already met all the requirements for a CDL, but have yet to pick up the CDL document from their State of domicile, their safety performance is expected to be the same as any other newly-credentialed CDL holder.
This exemption from the requirements of 49 CFR 383.25(a)(1) is effective during the period of September 23, 2018 through September 24, 2023.
The exemption is contingent upon CRST maintaining USDOT registration, minimum levels of public liability insurance, and not being subject to any “imminent hazard” or other out-of- service (OOS) order issued by FMCSA. Each driver covered by the exemption must maintain a valid driver's license and CLP with the required endorsements, not be subject to any OOS order or suspension of driving privileges, and meet all physical qualifications required by 49 CFR part 391.
This exemption from 49 CFR 383.25(a)(1) will allow CRST drivers who hold a CLP and have successfully passed a CDL skills test, to drive a CMV without a CDL holder being present in the front seat of the vehicle. The CDL holder must remain in the vehicle at all times while the CLP holder is driving—just not in the front seat.
During the period this exemption is in effect, no State may enforce any law or regulation that conflicts with or is inconsistent with the exemption with respect to a person or entity operating under the exemption (49 U.S.C. 31315(d)).
CRST must notify FMCSA within 5 business days of any accidents (as defined by 49 CFR 390.5) involving the operation of any of its CMVs while utilizing this exemption. The notification must be by email to
a. Exemption Identifier: “CRST”
b. Date of the accident,
c. City or town, and State, in which the accident occurred, or which is closest to the scene of the accident,
d. Driver's name and driver's license number,
e. Vehicle number and State license number,
f. Number of individuals suffering physical injury,
g. Number of fatalities,
h. The police-reported cause of the accident,
i. Whether the driver was cited for violation of any traffic laws, or motor carrier safety regulations, and
j. The total driving time and the total on-duty time of the CMV driver at the time of the accident.
The FMCSA does not believe the CLP-holders covered by the exemption will experience any deterioration of their safety record. However, should this occur, FMCSA will take all steps necessary to protect the public interest, including revocation of the exemption. The FMCSA will immediately revoke the exemption for failure to comply with its terms and conditions.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of application for exemption; request for comments.
FMCSA announces that it has received an application from Isuzu North America Corporation (Isuzu) requesting an exemption from the Federal requirement to hold a U.S. commercial driver's license (CDL) issued by one of the States. Isuzu requests that the exemption cover 12 of its commercial motor vehicle (CMV) drivers who will test-drive CMVs for Isuzu in the United States. Each of these 12 Isuzu employees holds a valid Japanese commercial license but lacks the U.S. residency necessary to obtain a CDL from one of the States of the United States. Isuzu believes the knowledge and skills tests and training program that drivers undergo to obtain a Japanese commercial license ensures that these drivers will achieve a level of safety that is equivalent to, or greater than, the level of safety that would be obtained by complying with the exemption.
Comments must be received on or before November 19, 2018.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket ID FMCSA-2006-25290 using any of the following methods:
•
•
•
•
Each submission must include the Agency name and the docket number for this notice. Note that DOT posts all comments received without change to
For information concerning this notice, contact Ms. Pearlie Robinson, FMCSA Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards; Telephone: 202-366-4325. Email:
FMCSA encourages you to participate by submitting comments and related materials.
If you submit a comment, please include the docket number for this notice (FMCSA-2006-25290), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
To submit your comment online, go to
FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from certain Federal Motor Carrier Safety Regulations. FMCSA must publish a notice of each exemption request in the
The Agency reviews the safety analyses and the public comments, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the
Isuzu has applied for an exemption from the CDL rules, specifically 49 CFR 383.23 that prescribes licensing requirements for drivers operating CMVs in interstate or intrastate commerce. Isuzu requests the exemption because its driver-employees are citizens and residents of Japan, and because they cannot apply for a CDL in any of the United States due to lack of residency. Isuzu explained that the exemption would allow a team of 12 employees (vehicle test engineers, technicians, mechanics and other employees) to drive CMVs in interstate commerce to test and evaluate production and prototype CMVs in the United States in order to design safe and well-tested vehicles for use on U.S. highways. The exemption would further provide an opportunity for these engineers to test how CMVs perform under various environmental and climatic conditions.
The drivers covered by the proposed exemption are Naoto Morimoto, Kenji Sugawara, Ryota Hisamatsu, Takehiro Oshima, Yasuhiro Sakai, Hiroaki Takahashi, Kazunori Aizawa, Atsushi Fujiwara, Kazuya Takahashi, Koichi Ueno, Takahisa Chiba, and Takamasa Ono. According to Isuzu, these drivers will not engage in driving CMVs for purpose of transporting merchandise as a commercial activity.
Each driver holds a valid Japanese commercial license, and as explained by Isuzu in previous exemption requests, drivers applying for a Japanese-issued commercial license must undergo a training program and pass knowledge and skills tests. Isuzu also stated in prior exemption requests that the knowledge and skills tests and training program that Japanese drivers undergo to obtain a Japanese commercial license ensure the exemption provides a level of safety that is equivalent to, or greater than, the level of safety obtained by complying with the U.S. requirement for a CDL. A copy of Isuzu's application for exemption is available for review in the docket for this notice.
FMCSA has previously determined the process for obtaining a Japanese commercial license is comparable to, or as effective as, the Federal CDL knowledge and skills requirements of 49 CFR part 383 as enforced by the States, and adequately assesses the driver's ability to operate CMVs in the U.S. Since 2003, FMCSA has granted Isuzu drivers similar exemptions [October 16, 2003 (68 FR 59677); April 3, 2007 (72 FR 15933); April 5, 2007 (72 FR 16870); September 5, 2008 (73 FR 51878); January 5, 2009 (74 FR 334); July 24, 2009 (74 FR 36809)].
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments concerning Form 8832, Entity Classification Election.
Written comments should be received on or before December 18, 2018 to be assured of consideration.
Direct all written comments to Laurie Brimmer, Internal Revenue Service, Room 6529, 1111 Constitution Avenue NW, Washington, DC 20224. Please send separate comments for each specific information collection listed below. You must reference the information collection's title, form number, reporting or record-keeping requirement number, and OMB number (if any) in you comment.
Requests for additional information or copies of the form and instructions should be directed to Charles G. Daniel at (202) 317-5754, at Internal Revenue Service, Room 6529, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet, at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number.
Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act that a meeting of the Advisory Committee on Cemeteries and Memorials will be held on October 30-October 31, 2018. The meeting sessions will take place at the Denver Regional Benefit Office, 155 Van Gordon Street, Lakewood, CO 80228. Sessions are open to the public, except when the Committee is conducting tours of VA facilities, participating in offsite events, participating in workgroup sessions, and conducting official Administrative business. Tours of the VA facilities are closed, to protect Veterans' privacy and personal information.
The purpose of the Committee is to advise the Secretary of Veterans Affairs on the administration of national cemeteries, soldiers' lots and plots, the selection of new national cemetery sites, the erection of appropriate memorials, and the adequacy of Federal burial benefits. The Committee will make recommendations to the Secretary regarding such activities.
On the morning of Tuesday, October 30, 2018, the Committee will convene with an open session at the Denver Regional Benefit Office from 8:30 a.m.-11:30 a.m., Mountain Time. The dial-in
On the morning of Wednesday, October 31, 2018, the Committee will convene with an open session at the Denver Regional Benefit Office from 8:30 a.m.-10:30 a.m., Mountain Time. The dial-in number is the same. The agenda will include status updates for the National Cemetery Scheduling Office and the Emblems of Belief Regulation; and discussions on any new charges or recommendations. In the afternoon session, 10:30 a.m.-4 p.m., Mountain Time, the Committee convene in a closed session to the Public, as it visits the Pikes Peak National Cemetery to review operations at a new cemetery for the rural Veterans. Under 5 U.S.C. 552b(c) under (9)(B), the meeting is closed because it would reveal information the disclosure of which would, “in the case of an agency, be likely to significantly frustrate implementation of a proposed agency action.” Any precipitous release of those discussions through an open session will frustrate implementation and potentially our Veterans who we consider our greatest customer/benefactor of the commission.
Any member of the public wishing to attend the meeting should contact Ms. Christine Hamilton, Designated Federal Officer, at (202) 461-5681. The Committee will also accept written comments. Comments may be transmitted electronically to the Committee at
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration |